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BEHRENBRUCH,\n\n Defendants.\n\n\n\n\n Defendants Telix Pharmaceuticals Ltd. and Christian P. Behrenbruch (\u201cDefendants\u201d),\n\n pursuant to Federal Rules of Civil Procedure 9(b) and 12(b)(6) and the Private Securities Litigation\n\n Reform Act of 1995, hereby move to dismiss the Consolidated Class Action Complaint (Dkt. 47)\n\n with prejudice.1 In support of this Motion, Defendants submit an accompanying Memorandum of\n\n Law.\n\n\n\n Dated: June 26, 2026 Respectfully submitted,\n\n By: /s/ Nilofer Umar\n Jacob V. Bradley\n Lucy R. Dollens\n QUARLES & BRADY LLP\n 135 N. Pennsylvania St., Suite 2400\n Indianapolis, IN 46204\n Telephone: (317) 957-5000\n\n 1\n The Parties have agreed to amend the case caption as reflected above to conform to the\n Consolidated Class Action Complaint, which asserts claims on behalf of Co-Lead Plaintiffs Tracy\n Tripp and Song Chee Tan against only two Defendants, Telix Pharmaceuticals Ltd. and Christian\n Behrenbruch.\n\n\n 1\n\fCase 1:25-cv-02299-JRO-MG Document 54 Filed 06/26/26 Page 2 of 3 PageID #: 447\n\n\n\n\n Fax: (317) 957-5010\n jacob.bradley@quarles.com\n lucy.dollens@quarles.com\n\n Nilofer Umar (pro hac vice)\n Heather Benzmiller Sultanian (pro hac vice)\n SIDLEY AUSTIN LLP\n One South Dearborn Street\n Chicago, IL 60603\n Telephone: (312) 853-7000\n Fax: (312) 853-7036\n numar@sidley.com\n hsultanian@sidley.com\n\n Counsel for Defendants\n\n\n\n\n 2\n\fCase 1:25-cv-02299-JRO-MG Document 54 Filed 06/26/26 Page 3 of 3 PageID #: 448\n\n\n\n\n CERTIFICATE OF SERVICE\n\n I hereby certify that on June 26, 2026, a copy of the foregoing Motion to Dismiss was filed\n\n electronically. 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(Attachments: # 1 Proposed Order)(Bradley, Jacob) (Entered: 06/19/2026)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/464402201/","id":464402201,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/71895569/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/479574720/","id":479574720,"tags":[],"absolute_url":"/docket/71895569/50/thomas-v-telix-pharmaceuticals-ltd/","date_created":"2026-05-18T10:21:28.925924-07:00","date_modified":"2026-05-18T10:21:28.932931-07:00","sha1":"","page_count":null,"file_size":null,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"50","attachment_number":null,"pacer_doc_id":"073011775607","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Order on Motion to Vacate","acms_document_guid":""}],"date_created":"2026-05-18T10:21:28.901192-07:00","date_modified":"2026-08-12T20:24:11.470687-07:00","date_filed":"2026-05-18","time_filed":"12:21:11","entry_number":50,"recap_sequence_number":"2026-05-18.001","pacer_sequence_number":168,"description":"ORDER granting 49 Joint MOTION to Suspend Initial Pretrial Conference. The June 29, 2026 Initial Pretrial Conference at 2:00 p.m. (Eastern) is hereby VACATED. Counsel to notify the magistrate judge's chambers once a ruling is issued on the pending Motion to Dismiss. Signed by Magistrate Judge Mario Garcia on 5/18/2026.(SPT) (Entered: 05/18/2026)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/464114055/","id":464114055,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/71895569/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/479278355/","id":479278355,"tags":[],"absolute_url":"/docket/71895569/49/thomas-v-telix-pharmaceuticals-ltd/","date_created":"2026-05-14T14:25:17.825100-07:00","date_modified":"2026-05-14T14:25:17.830892-07:00","sha1":"","page_count":null,"file_size":null,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"49","attachment_number":null,"pacer_doc_id":"073011772142","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Vacate","acms_document_guid":""}],"date_created":"2026-05-14T14:25:17.804321-07:00","date_modified":"2026-08-12T20:24:11.448396-07:00","date_filed":"2026-05-14","time_filed":"16:39:48","entry_number":49,"recap_sequence_number":"2026-05-14.001","pacer_sequence_number":163,"description":"Joint MOTION to Vacate Initial Pretrial Conference, filed by Defendants CHRISTIAN P BEHRENBRUCH, DARREN SMITH, TELIX PHARMACEUTICALS LTD, KYAHN WILLIAMSON. (Attachments: # 1 Text of Proposed Order)(Bradley, Jacob) (Entered: 05/14/2026)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/463132504/","id":463132504,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/71895569/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/478269098/","id":478269098,"tags":[],"absolute_url":"/docket/71895569/48/thomas-v-telix-pharmaceuticals-ltd/","date_created":"2026-05-06T09:25:58.033276-07:00","date_modified":"2026-05-06T09:25:58.041568-07:00","sha1":"","page_count":null,"file_size":null,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"48","attachment_number":null,"pacer_doc_id":"073011753644","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"SCHEDULING Order","acms_document_guid":""}],"date_created":"2026-05-06T09:25:57.989545-07:00","date_modified":"2026-08-12T20:24:11.425197-07:00","date_filed":"2026-05-05","time_filed":null,"entry_number":48,"recap_sequence_number":"2026-05-05.001","pacer_sequence_number":161,"description":"SCHEDULING ORDER: Telephonic Initial Pretrial Conference set for 6/29/2026 at 2:00 PM (Eastern Time) before Magistrate Judge Mario Garcia. The information needed to participate in this telephonic conference will be provided by a separate notification. Signed by Magistrate Judge Mario Garcia on 5/5/2026.(SPT) (Entered: 05/06/2026)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/462127116/","id":462127116,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/71895569/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/477234898/","id":477234898,"tags":[],"absolute_url":"/docket/71895569/47/thomas-v-telix-pharmaceuticals-ltd/","date_created":"2026-04-27T14:07:06.394850-07:00","date_modified":"2026-10-01T19:33:29.734349-07:00","sha1":"12c6b6c7eaa337d7e85f3aebaea88dfc9eb34896","page_count":90,"file_size":916645,"filepath_local":"recap/gov.uscourts.insd.225663/gov.uscourts.insd.225663.47.0.pdf","filepath_ia":"https://archive.org/download/gov.uscourts.insd.225663/gov.uscourts.insd.225663.47.0.pdf","ia_upload_failure_count":1,"thumbnail":null,"thumbnail_status":0,"plain_text":"Case 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 1 of 90 PageID #:\n 241\n\n\n\n UNITED STATES DISTRICT COURT\n SOUTHERN DISTRICT OF INDIANA\n\n JOHN THOMAS, Individually and on Case No: 1:25-cv-02299-JRO\n behalf of all others similarly situated,\n\n Plaintiff, CONSOLIDATED CLASS ACTION\n COMPLAINT FOR VIOLATIONS OF\n v. THE FEDERAL SECURITIES LAWS\n\n TELIX PHARMACEUTICALS LTD., JURY TRIAL DEMANDED\n CHRISTIAN P. BEHRENBRUCH, DARREN\n SMITH, and KYAHN WILLIAMSON,\n\n Defendants.\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 2 of 90 PageID #:\n 242\n\n\n\n TABLE OF CONTENTS\n\n I. NATURE OF THE ACTION ............................................................................................. 1\n\n II. JURISDICTION AND VENUE ......................................................................................... 6\n\n III. PARTIES ............................................................................................................................ 7\n\n A. Plaintiffs .................................................................................................................. 7\n\n B. Defendants .............................................................................................................. 7\n\n C. Relevant Non-Parties .............................................................................................. 8\n\n IV. SUBSTANTIVE ALLEGATIONS .................................................................................... 9\n\n A. Background ............................................................................................................. 9\n\n B. Telix Knew the FDA Would Not Approve TLX101-CDx (Brain Agent) ............ 10\n\n 1. TLX101-CDx (Pixclara) for Brain Cancer Imaging ................................. 10\n\n 2. Defendants Knew the FDA Found its Clinical Data Insufficient ............. 10\n\n 3. Defendants Made False and Misleading Statements About\n TLX101-CDx (Brain Agent)..................................................................... 12\n\n 4. The FDA Rejects TLX101-CDx (Brain Agent), Causing the\n Telix Stock to Fall Damaging Investors ................................................... 13\n\n C. The FDA Did Not Approve a Phase 3 Trial of TLX591 (Prostate Drug)............. 14\n\n 1. TLX591 For the Treatment of Prostate Cancer ........................................ 14\n\n 2. Telix Misleads Investors as to the \u201cPhase 3\u201d Status of TLX591\n (Prostate Drug) .......................................................................................... 15\n\n 3. The Formal SEC Investigation is Revealed; Telix Stock Drops\n Damaging Investors .................................................................................. 17\n\n 4. The Aftermath of the Announced SEC Investigation ............................... 18\n\n\n i\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 3 of 90 PageID #:\n 243\n\n\n\n 5. Defendants\u2019 Post-Class Period Statements Prove Class Period\n Statements Were Misleading .................................................................... 19\n\n D. Telix Misrepresents TLX250 (Kidney Agent) Risks ............................................ 22\n\n 1. Background - First FDA Rejection ........................................................... 22\n\n 2. Defendants Ignore the FDA\u2019s Recommendations .................................... 23\n\n 3. Prior to Resubmission in December 2024, Telix Employees\n Presented Behrenbruch with a List of the Risks to FDA Approval .......... 23\n\n 4. Telix Resubmits the TLX250 BLA (Kidney Agent) ................................ 25\n\n 5. The Second FDA Rejection of TLX250 (Kidney Agent) ......................... 27\n\n 6. Telix Knew it had a Comparability Problem Between the Trial\n Drug and Commercial Product, Highlighted by Particulates in\n the Solution ............................................................................................... 28\n\n 7. Telix Knew of the Problems at GBI ......................................................... 31\n\n 8. Telix Knew of the Problems at 3DI .......................................................... 33\n\n 9. Telix is Still Working to Address the FDA\u2019s Concerns ........................... 36\n\n E. The \u201cPump-and-Dump\u201d Scheme .......................................................................... 36\n\n F. Defendant Behrenbruch\u2019s Stock Sales Triggered a Duty to Disclose .................. 41\n\n V. DEFENDANTS\u2019 MISREPRESENTATIONS .................................................................. 42\n\n VI. LOSS CAUSATION ......................................................................................................... 67\n\n VII. ADDITIONAL SCIENTER ALLEGATIONS ................................................................. 72\n\n A. Defendants Were Motivated to Conceal the Truth While Telix\u2019s\n Co-Founders Sold Four Million Shares ................................................................ 73\n\n B. Behrenbruch\u2019s Refusal to Heed Expert Advice Can Best Be Explained\n by Fraudulent Intent .............................................................................................. 74\n\n ii\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 4 of 90 PageID #:\n 244\n\n\n\n C. Defendant Behrenbruch was a \u201cVery Hands-on CEO\u201d ........................................ 75\n\n D. Defendant Behrenbruch was Debriefed After Every FDA Meeting ..................... 76\n\n E. The FDA was in Regular Contact With Telix ...................................................... 76\n\n F. Telix\u2019s Pipeline Drugs Were of Critical Importance to the Company.................. 77\n\n VIII. CLASS ACTION ALLEGATIONS ................................................................................. 77\n\n IX. CAUSES OF ACTION ..................................................................................................... 80\n\n X. PRAYER FOR RELIEF ................................................................................................... 83\n\n XI. JURY TRIAL DEMANDED ............................................................................................ 84\n\n\n\n\n iii\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 5 of 90 PageID #:\n 245\n\n\n\n Court-appointed co-Lead Plaintiffs Tracy Tripp and Song Chee Tan (\u201cPlaintiffs\u201d),\n\n individually and on behalf of all other persons similarly situated, by Plaintiffs\u2019 undersigned\n\n attorneys, for Plaintiffs\u2019 complaint against Defendants (defined below), allege the following based\n\n upon personal knowledge as to Plaintiffs and Plaintiffs\u2019 own acts, and information and belief as to\n\n all other matters, based upon, among other things, the investigation conducted by and through\n\n Plaintiffs\u2019 attorneys, which included, among other things, a review of the Defendants\u2019 public\n\n documents, public filings, wire and press releases published by and regarding Telix\n\n Pharmaceuticals Ltd. (\u201cTelix\u201d or the \u201cCompany\u201d), and information readily obtainable on the\n\n Internet, as well as through interviews of former employees of the Company. Plaintiffs believe that\n\n substantial evidentiary support will exist for the allegations set forth herein after a reasonable\n\n opportunity for discovery.\n\n I. NATURE OF THE ACTION\n\n 1. This is a class action on behalf of persons or entities who purchased or otherwise\n\n acquired publicly traded Telix American Depository Shares (\u201cADSs\u201d) between November 14,\n\n 2024 and August 28, 2025, inclusive (the \u201cClass Period\u201d). Plaintiffs seek to recover compensable\n\n damages caused by Defendants\u2019 violations of the federal securities laws and to pursue remedies\n\n under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the \u201cExchange Act\u201d) and\n\n Rule 10b-5 promulgated thereunder.\n\n 2. The Class Period begins on November 14, 2024, with the commencement of trading\n\n in Telix ADSs on the Nasdaq Global Select Market. Prior to that date, Telix shares traded only on\n\n the Australian Securities Exchange.\n\n 3. Telix is a biopharmaceutical company and Defendant Behrenbruch is Telix\u2019s CEO.\n\n Defendants misled investors regarding Telix\u2019s three most important drug candidates so that\n\n 1\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 6 of 90 PageID #:\n 246\n\n\n\n Defendant Behrenbruch could sell two million shares of his Telix stock at artificially inflated\n\n prices. First, Defendants touted the abilities of Telix\u2019s investigation agent for the imaging of brain\n\n cancer (TLX101-CDx (Pixclara), or the \u201cBrain Agent\u201d), even though the Food and Drug\n\n Administration (the \u201cFDA\u201d) had already told the Company the clinical data in its New Drug\n\n Application (\u201cNDA\u201d) did not provide substantial evidence of effectiveness. When the FDA\n\n rejected the Brain Agent NDA on April 25, 2025, the Company\u2019s ADSs dropped from $18.80 to\n\n $17.57. Second, Defendants asserted Telix\u2019s prostate cancer treatment (TLX591, or the \u201cProstate\n\n Drug\u201d) had commenced Phase 3 trials, but the FDA had not authorized a full Phase 3 trial. When\n\n Telix announced on July 22, 2025, it had been subpoenaed by the Securities and Exchange\n\n Commission (the \u201cSEC\u201d) regarding these statements, the stock price dopped from $16.28 to\n\n $13.89. Finally, Defendants omitted to disclose material deficiencies in Telix\u2019s Biologics License\n\n Application (\u201cBLA\u201d) for the Company\u2019s kidney cancer imaging agent (TLX250-CDx (Zircaix),\n\n or the \u201cKidney Agent\u201d). According to a former high-level Telix employee, Defendant Behrenbruch\n\n knew all about these material undisclosed deficiencies but insisted on pushing the BLA regardless.\n\n When Telix announced the FDA rejected the Kidney Agent BLA on August 28, 2025, Telix ADSs\n\n declined from $12.10 to $9.55. Defendant Behrenbruch sold his two million Telix shares on\n\n February 27, 2025 before the truth was disclosed, when the Company\u2019s ADSs traded in the range\n\n of $18.60 to $19.30.\n\n 4. Prior to the Class Period, on October 17, 2024, Telix filed a Form 20-F registration\n\n statement with the SEC containing false and misleading statements about the Company\u2019s Prostate\n\n Drug. Though Telix boasted about its Prostate Drug being in Phase 3 trials in the United States,\n\n the FDA had not actually authorized a full Phase 3 trial. The FDA had only authorized the first\n\n\n\n 2\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 7 of 90 PageID #:\n 247\n\n\n\n part of the two-part Phase 3 trial. These false statements caused the ADSs to trade at artificially\n\n inflated prices from the moment they began trading on the NASDAQ on November 14, 2024.\n\n 5. On February 20, 2025, Telix reported its full year 2024 financial results and updated\n\n the market on its new cancer drugs. Investors were keenly attuned to the new drug pipeline and\n\n Telix highlighted the planned commercial launches of Telix\u2019s Kidney Agent and Brain Agent, as\n\n well as reporting on its Prostate Drug.\n\n 6. In Telix\u2019s 2024 Annual Report issued the same day, the Company\u2019s founder and\n\n CEO Christian Behrenbruch proudly provided the market with good news: Telix\u2019s \u201cnew drug\n\n applications . . . have the potential to significantly impact the standard of care while super-\n\n charging Telix\u2019s cash generation capability.\u201d1 Behrenbruch\u2019s assessment was unabashedly\n\n positive, Telix had \u201cbuilt a strong foundation over the last few years, and with several major\n\n inflection points achieved in 2024, we are on the cusp of exponential growth.\u201d The news was\n\n bullish, and the market reacted accordingly with the ADSs increasing from a close of $17.41 prior\n\n to the statements to close at $20.93 two days later.\n\n 7. Over the next several days, Telix issued two additional press releases announcing\n\n purported milestones for its pipeline drugs. On February 25, 2025, Telix reported that it had begun\n\n dosing patients in its Phase 3 trial of TLX591 (Prostate Drug). On February 26, 2025, Telix\n\n announced the FDA had accepted the Company\u2019s BLA for Telix\u2019s key imaging agent TLX250-\n\n CDx (Kidney Agent), \u201cpaving the way for a U.S. commercial launch in 2025.\u201d\n\n\n\n\n 1\n Unless otherwise stated, all emphasis is added.\n\n 3\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 8 of 90 PageID #:\n 248\n\n\n\n 8. One day later, on February 27, 2025, Defendant Behrenbruch and his co-founder\n\n Andreas Kluge each sold two million Telix shares for $29.50 per share Australian for a total of\n\n $118 million Australian (over $73 million American). (The sale was at a discount to the closing\n\n market price on the Australian Securities Exchange where Telix common shares trade, a standard\n\n practice for block trades.) Behrenbruch and Kluge\u2019s timing was impeccable, as is indicated in the\n\n chart of the common shares below.\n\n\n\n\n 9. This sale was unusual, as a diligent search found that neither Behrenbruch nor\n\n Kluge had sold any shares since January 2022. Further, their timing was not mere luck.\n\n Behrenbruch knew something the market didn\u2019t. He traded on the basis of material non-public\n\n inside information. Defendants\u2019 statements were false and misleading and calculated to enable\n\n Behrenbruch to sell a massive portion of his holdings for significantly more than the stock would\n\n be worth when the truth was eventually revealed.\n\n 10. Contrary to Defendants\u2019 public statements, Defendants knew Telix\u2019s drug pipeline\n\n was not what they had portrayed it to be. For instance, on April 25, 2025, the FDA rejected Telix\u2019s\n\n application for approval of TLX101-CDx (Brain Agent) because the \u201cclinical data submitted in\n\n\n 4\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 9 of 90 PageID #:\n 249\n\n\n\n this application did not provide substantial evidence of effectiveness.\u201d Investors were surprised,\n\n and the ADSs declined from $18.80 to $17.57. Defendants were not. The FDA had already told\n\n Telix of \u201cany issues that could preclude an approval action\u201d at the mid-cycle meeting in early\n\n February 2025. See \u00a7 IV.B.\n\n 11. Further, contrary to Defendants\u2019 statements to investors, the FDA had not\n\n authorized a full Phase 3 clinical trial of TLX591 (Prostate Drug). The FDA only approved a\n\n portion of the Phase 3 trial. Defendants\u2019 statements on the subject were so misleading that the SEC\n\n authorized a formal investigation of Telix. When announced to investors on July 22, 2025, this\n\n caused Telix ADSs to drop from $16.28 to $13.89. The SEC formal investigation remains ongoing.\n\n See \u00a7 IV.C.\n\n 12. Finally, Defendants knew the TLX250-CDx (Zircaix) (Kidney Agent) BLA was\n\n plagued by material deficiencies prior to Telix submitting it to the FDA in December 2024. On\n\n August 28, 2025, Telix announced that the FDA rejected the BLA. The announcement shocked\n\n the market causing Telix ADSs to drop from $12.10 to $9.55, off 21%. The FDA was troubled by\n\n a change in the manufacturing process that created particulates in the drug solution, a problem that\n\n Defendants knew about since the first half of 2024. Further, the FDA found deficiencies at two\n\n third-party manufacturers that required remediation. Prior to submitting the BLA in December\n\n 2024, Telix had documented serious concerns at both third-party manufactures, and conducted a\n\n mock audit of one of them that discovered such significant deficiencies that a senior level Telix\n\n employee urged Defendant Behrenbruch to find another provider. Behrenbruch refused to do so.\n\n See \u00a7 IV.D.\n\n 13. Defendants chose to speak about Telix\u2019s drug pipeline. The federal securities laws\n\n prohibit them from omitting information that made their affirmative statements misleading. Not\n\n 5\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 10 of 90 PageID #:\n 250\n\n\n\n only did Defendants omit material information making their statements misleading, but Defendant\n\n Behrenbruch had a duty to disclose any material non-public information known to him before he\n\n could sell Telix shares. Defendant Behrenbruch remained silent and sold two million shares of\n\n Telix stock at artificially inflated prices netting proceeds of $59 million Australian. He\n\n substantially benefited by breaking the law. Plaintiffs were not so lucky.\n\n II. JURISDICTION AND VENUE\n\n 14. The claims asserted herein arise under and pursuant to Sections 10(b) and 20(a) of\n\n the Exchange Act (15 U.S.C. \u00a7\u00a7 78j(b) and 78t(a)) and Rule 10b-5 promulgated thereunder by the\n\n SEC (17 C.F.R. \u00a7 240.10b-5).\n\n 15. This Court has jurisdiction over the subject matter of this action pursuant to 28\n\n U.S.C. \u00a7 1331, and Section 27 of the Exchange Act (15 U.S.C. \u00a778aa).\n\n 16. Venue is proper in this judicial district pursuant to 28 U.S.C. \u00a7 1391(b) and Section\n\n 27 of the Exchange Act (15 U.S.C. \u00a7 78aa(c)) as the alleged misstatements entered and the\n\n subsequent damages took place in this judicial district. According to Telix\u2019s 2024 Form 20-F filed\n\n with the SEC on February 24, 2025, the \u201cmajority of [Telix\u2019s] workforce is in the United States,\n\n based out of our U.S. headquarters in Indianapolis, Indiana. . . .\u201d\n\n 17. In connection with the acts, conduct and other wrongs alleged in this complaint,\n\n Defendants, directly or indirectly, used the means and instrumentalities of interstate commerce,\n\n including but not limited to, the United States mails, interstate telephone communications and the\n\n facilities of the national securities exchange.\n\n\n\n\n 6\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 11 of 90 PageID #:\n 251\n\n\n\n III. PARTIES\n\n A. Plaintiffs\n\n 18. Plaintiffs, as set forth in their previously-filed Certifications (ECF Nos. 10-1 and\n\n 14-3), acquired Telix ADSs at artificially inflated prices during the Class Period and were damaged\n\n upon the revelation of the alleged corrective disclosures and materialization of the misrepresented\n\n risks.\n\n B. Defendants\n\n 19. Defendant Telix is a biopharmaceutical company focused on the development and\n\n commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical\n\n technologies. Telix is incorporated in Australia, and its U.S. headquarters are in Indianapolis.\n\n 20. Telix American Depositary Shares (\u201cADS\u201d or \u201cADSs\u201d)\n\n trade on the Nasdaq Global Select Market (the \u201cNASDAQ\u201d) under the ticker symbol \u201cTLX\u201d. Telix\n\n \u201cordinary shares\u201d or \u201ccommon shares\u201d have been listed on the Australian Securities Exchange, or\n\n ASX, since November 2017. Each Telix ADS represents one ordinary share. Telix ADSs trade in\n\n American dollars and the ordinary shares trade in Australian dollars. Unless otherwise noted, all\n\n ADS references are in American dollars and common share or ordinary share references are in\n\n Australian dollars.\n\n 21. Defendant Christian P. Behrenbruch (\u201cBehrenbruch\u201d) served as the Company\u2019s\n\n Chief Executive Officer (\u201cCEO\u201d) at all relevant times. He co-founded Telix and is its executive\n\n director.\n\n 22. Defendant Behrenbruch:\n\n (a) directly participated in the management of the Company;\n\n\n\n\n 7\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 12 of 90 PageID #:\n 252\n\n\n\n (b) was directly involved in the day-to-day operations of the Company at the\n\n highest levels;\n\n (c) was privy to confidential proprietary information concerning the Company\n\n and its business and operations;\n\n (d) was directly or indirectly involved in drafting, producing, reviewing and/or\n\n disseminating the false and misleading statements and information alleged\n\n herein;\n\n (e) was directly or indirectly involved in the oversight or implementation of the\n\n Company\u2019s internal controls;\n\n (f) was aware of or recklessly disregarded the fact that the false and misleading\n\n statements were being issued concerning the Company; and/or\n\n (g) approved or ratified these statements in violation of the federal securities\n\n laws.\n\n 23. Telix is liable for the acts of Defendant Behrenbruch and its employees under the\n\n doctrine of respondeat superior and common law principles of agency because all of the wrongful\n\n acts complained of herein were carried out within the scope of their employment.\n\n 24. The scienter of Defendant Behrenbruch and other employees and agents of the\n\n Company is similarly imputed to Telix under respondeat superior and agency principles.\n\n 25. Defendant Telix and Defendant Behrenbruch are collectively referred to herein as\n\n \u201cDefendants.\u201d\n\n C. Relevant Non-Parties\n\n 26. Dr. Andreas Kluge co-founded Telix with Defendant Behrenbruch and served as a\n\n director of the Company from its inception in 2017 until October 17, 2024. Dr. Kluge sold two\n\n 8\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 13 of 90 PageID #:\n 253\n\n\n\n million ordinary shares of Telix stock on February 27, 2025, for $29.50 (Australian) per ordinary\n\n share, as described herein. Kluge continued to work for Telix as a consultant after retiring from\n\n the Board of Directors.\n\n 27. Former Employee Number 1 (\u201cFE-1\u201d) was the Senior Vice-President of Global\n\n Manufacturing at Telix Pharmaceuticals from November 2023 to August 2025, and the VP of\n\n Commercial Manufacturing from April 2023 to October 2023. FE-1 was in charge of the global\n\n team at Telix responsible for drug development and manufacturing. FE-1 oversaw supply chain\n\n and logistics for drug delivery. FE-1 reported to Group Chief Operating Officer Darren Patti. As\n\n detailed herein, FE-1 dealt directly with CEO Behrenbruch on a regular basis. FE-1 participated\n\n in meetings with the FDA, and/or participated in team debriefings that occurred directly after Telix\n\n had meetings with the FDA. James Stonecypher, Telix\u2019s Chief Development Officer, typically\n\n attended FDA meetings on behalf of Telix, and then immediately debriefed senior Telix executives\n\n including FE-1 and Defendant Behrenbruh. As a result of the Chemistry, Manufacturing, and\n\n Controls (\u201cCMC\u201d) issues with TLX250-CDx (Zircaix) (Kidney Agent), FE-1 was significantly\n\n involved in the BLA for the Kidney Agent. FE-1 has 30 years of experience working in drug\n\n manufacturing and has been a part of numerous NDAs and BLAs at different companies. FE-1\n\n never experienced so many CMC issues on one BLA/NDA as Telix did with the Kidney Agent.\n\n IV. SUBSTANTIVE ALLEGATIONS\n\n A. Background\n\n 28. Telix is a biopharmaceutical company focused on sales, development and\n\n commercialization of therapeutic and diagnostic radiopharmaceuticals.\n\n 29. Radiopharmaceuticals are a class of drugs that combine radioactive isotopes with\n\n biological molecules to target, diagnose and treat specific diseases. The combination of a targeting\n\n 9\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 14 of 90 PageID #:\n 254\n\n\n\n agent with radioactive isotope allows, at least in theory, precise delivery of radiation to the tumor\n\n while minimizing harm to surrounding healthy tissue.\n\n B. Telix Knew the FDA Would Not Approve TLX101-CDx (Brain Agent)\n\n 1. TLX101-CDx (Pixclara) for Brain Cancer Imaging\n\n 30. TLX101-CDx (Pixclara) (Brain Agent) is an investigation agent for the imaging of\n\n glioma, a rare and life-threatening brain cancer. In October 2020, TLX101-CDx was granted\n\n orphan drug designation by the FDA in the United States for the imaging of glioma.\n\n 31. In August 2024, Telix submitted an NDA to the FDA for TLX101-CDx for the\n\n characterization of progressive or recurrent glioma from treatment related changes in both adult\n\n and pediatric patients through the 505(b)(2) NDA regulatory pathway.\n\n 32. In October 2024, the FDA accepted the NDA, granted priority review and assigned\n\n a PDUFA goal date of April 26, 2025.\n\n 33. TLX101-CDx was granted fast track designation by the FDA for this indication in\n\n April 2024.\n\n 34. The FDA rejected TLX101-CDx in April 2025.\n\n 2. Defendants Knew the FDA Found its Clinical Data Insufficient\n\n 35. On April 25, 2025, the FDA issued a Complete Response Letter (\u201cTLX101 CRL\u201d)\n\n to Telix rejecting its application for approval of TLX101-CDx (Brain Agent). The TLX101 CRL\n\n made clear that Telix\u2019s trial did not achieve statistically significant results in diagnosing the target\n\n cancer. The TLX101 CRL stated:\n\n The clinical data submitted in this application did not provide substantial\n evidence of effectiveness for floretyrosine F 18 [TLX101]. The efficacy study, 18F-\n TLX101-CDx-203, was considered adequate and well-controlled but demonstrated\n borderline diagnostic performance with lower bounds of the 95% confidence\n intervals ranging from 58% to 73% sensitivity and from 36% to 51% specificity\n across three blinded central readers. In addition, it was a single center study and\n 10\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 15 of 90 PageID #:\n 255\n\n\n\n had potential for bias in reference standard determination, further limiting its\n persuasiveness.\n\n 36. The TLX101 CRL was not publicly available at the time it was issued. However, a\n\n redacted version of the TLX CRL was later posted on the FDA\u2019s website. The publicly available\n\n version of the TLX CRL is attached hereto as Exhibit A.\n\n 37. The April 25, 2025 TLX101 CRL did not come as a surprise to Defendants. The\n\n FDA communicated its concerns to Telix numerous times and for months prior to issuing the\n\n TLX101 CRL.\n\n 38. The FDA maintains strict requirements for communications to sponsors of drug\n\n applications granted priority review such as Telix\u2019s TLX101-CDx submission. These requirements\n\n are set forth in the FDA\u2019s \u201cReview Process Desk Reference Guide\u201d for NDAs. See Ctr. for Drug\n\n Eval. & Rsch., CDER 21st Century Review Process Desk Reference Guide: New Drug Application\n\n and Biologics License Application Reviews (\u201cCDER Review Process\u201d) available at\n\n https://www.fda.gov/media/78941/download.\n\n 39. The FDA review team holds an internal mid-cycle meeting within 3 months of\n\n accepting an NDA for priority review \u2013 and then conveys an update to the applicant within two\n\n weeks of that mid-cycle review meeting. Id. at 28-30. At the mid-cycle meeting, the FDA review\n\n team\u2019s objectives include: \u201cIdentify any issues that could preclude an approval action.\u201d Id. at 28.\n\n The review team is generally expected to update the applicant on the review process within two\n\n weeks of the mid-cycle meeting and inform the applicant of \u201c[a]ny significant issues identified by\n\n the review team to date.\u201d Id. at 30.\n\n 40. This mid-cycle FDA communication of \u201cany issues that could preclude an approval\n\n action\u201d to Telix would have occurred no later than three months and two weeks after the FDA\n\n\n 11\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 16 of 90 PageID #:\n 256\n\n\n\n accepted the NDA for TLX101-CDx (Pixclara) on October 24, 2024 \u2013 which would have been\n\n early February 2025.\n\n 41. After the mid-cycle meeting, the CDER Review Process specifically required (i) a\n\n \u201clate-cycle meeting\u201d between Telix and the FDA at least two months prior to the April 26, 2025\n\n PDUFA date\u2014late February 2025, and (ii) a \u201cbackground package\u201d for the late-cycle meeting be\n\n provided by the FDA to Telix not less than 12 days prior to that late-cycle meeting \u2013 or mid\n\n February 2025. See CDER Review Process at 39-40. \u201cThe late-cycle meeting is intended to share\n\n information [and] identify deficiencies . . . .\u201d Id. at 40. The background package would have\n\n specifically identified the \u201c[m]eeting agenda\u201d and \u201c[s]ubstantive application issues.\u201d Id.\n\n 42. The FDA would have notified Telix of the deficiencies identified in the April 25,\n\n 2025, Complete Response Letter via the background package and late-cycle review meeting before\n\n Defendants\u2019 false and misleading statements in the February 20, 2025, press release, conference\n\n call and Annual Report, and before Telix\u2019s co-founders sold four million Telix shares on February\n\n 27, 2025.\n\n 3. Defendants Made False and Misleading Statements About TLX101-\n CDx (Brain Agent)\n\n 43. Until April 25, 2025, when the FDA rejected the NDA for TLX101-CDx (Pixclara),\n\n Defendants made misleading statements about launching TLX101. For example, as detailed herein\n\n at Section V detailing all of Defendants\u2019 false and misleading statements, the Company\u2019s press\n\n release and Annual Report published on February 20, 2025, both indicated that Telix anticipated\n\n commercial launch of TLX101-CDx (Pixclara) in 2025.\n\n 44. Similarly, during the Company\u2019s February 20, 2025 conference call after the press\n\n release and annual report were published, Telix told investors:\n\n\n 12\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 17 of 90 PageID #:\n 257\n\n\n\n [G]lobal expansion of Telix\u2019s industry leading precision medicine portfolio is a key\n driver of our growth strategy. In the U.S. our commercial portfolio will continue\n to expand with the launches of our urology products Gozellix and Zircaix,\n followed by Pixclara for our neuro franchise.\n\n ***\n\n Finally, our Pixclara agent will bring to neurology customers a technology that\n will quickly identify treatment related inflammation from tumor progression or\n pseudo progression and determine the best treatment pathway for the patient.\n\n 45. On February 24, 2025, Telix filed a Form 20-F annual report that misleadingly\n\n described the trial data for TLX101-CDx, claiming its \u201ctrials provided evidence that TLX101-\n\n CDx tended to result in higher sensitivity and specificity\u201d than magnetic resonance imaging and\n\n MRI. (See \u00b6 223 for full quoted text.)\n\n 46. As Defendants already knew at the time of these statements, the FDA had found\n\n the trial data in the NDA for TLX101-CDx (Pixclara) \u201cdid not provide substantial evidence of\n\n effectiveness.\u201d Accordingly, there was no reasonable basis to state that Telix anticipated launching\n\n TLX101 (Pixclara) in 2025 or that it would expand the Company\u2019s commercial portfolio in the\n\n U.S., and it was misleading for Defendants to assert the TLX101 (Pixclara) trial data \u201cprovided\n\n evidence\u201d that TLX101-CDx was better than alternative methods of imaging.\n\n 4. The FDA Rejects TLX101-CDx (Brain Agent), Causing the Telix Stock\n to Fall Damaging Investors\n\n 47. On April 28, 2025, Telix posted an announcement on its website entitled \u201cTelix\n\n Provides Regulatory Update on TLX101-CDx\u201d announcing the Company had received a Complete\n\n Response Letter from the FDA requiring Telix to provide \u201cadditional confirmatory clinical\n\n evidence\u201d to \u201cprogress the application.\u201d\n\n\n\n\n 13\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 18 of 90 PageID #:\n 258\n\n\n\n 48. The market reaction to news of the TLX101 CRL was significant. Telix ADSs\n\n declined from a close of $18.80 on April 25, 2025, to close at $17.57 on the next trading day April\n\n 28, 2025.\n\n 49. Telix did not launch TLX101 (Pixclara) in 2025. Telix did not resubmit an\n\n application for Pixclara to the FDA for approval until March 16, 2026. The deficiencies in the\n\n original application were material and the delays significant to the Company\u2019s ability to monetize\n\n its capital investment in the research and development of the Brain Agent.\n\n C. The FDA Did Not Approve a Phase 3 Trial of TLX591 (Prostate Drug)\n\n 1. TLX591 For the Treatment of Prostate Cancer\n\n 50. In February 2025, Telix described TLX 591 in the Company\u2019s Form 20-F filing\n\n with the SEC as its \u201clead therapeutic product candidate.\u201d Telix claimed TLX591 \u201chas the potential\n\n to deliver improved patient outcomes with an efficient dosing regimen.\u201d\n\n 51. The stated belief from Telix was that TLX591 has a number of advantages over the\n\n current radiopharmaceutical prostate therapeutic (Pluvicto), including a short, patient-friendly\n\n dosing regimen that delivers a meaningful therapeutic index and low occurrence of the off-target\n\n side effects that are common with currently marketed small molecule PSMA\n\n radiopharmaceuticals.\n\n 52. TLX591, unlike Pluvicto, utilizes a novel antibody approach to target cancer cells.\n\n TLX591 combines a radioactive isotope (lutetium-177) with the antibody rosopatamab, which\n\n targets PSMA (prostate-specific membrane antigen).\n\n 53. According to Telix\u2019s Form 20-F filed with the SEC: \u201cOur prostate cancer programs\n\n target PSMA, a well-validated protein target for the delivery of both therapeutic and diagnostic\n\n radiopharmaceuticals that is highly expressed on prostate cancer cells with low expression on\n\n 14\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 19 of 90 PageID #:\n 259\n\n\n\n healthy cells.\u201d The antibody (along with the radiation) attaches to the PSMA on the tumor cell,\n\n and the radiation is delivered directly to the cancer.\n\n 2. Telix Misleads Investors as to the \u201cPhase 3\u201d Status of TLX591 (Prostate\n Drug)\n\n 54. Prior to and during the Class Period, Defendants misled investors about the FDA\u2019s\n\n approval of Telix\u2019s Phase 3 trial of TLX591 referred to as ProstACT Global.\n\n 55. When the FDA approved ProstACT Global Phase 3 to commence enrollment in the\n\n U.S., the approval was only for the first part of the trial, which was similar to a Phase 2 study to\n\n determine drug safety and proper dosage (\u201cPart 1\u201d).\n\n 56. Before Telix could commence \u201cPart 2\u201d of the ProstACT Global Phase 3 trial, which\n\n would test for efficacy and was more akin to a standard Phase 3 trial, Telix would have to first\n\n present the safety data from Part 1 to the FDA and obtain FDA approval to move forward with\n\n Part 2.\n\n 57. The FDA\u2019s requirement that Telix obtain the FDA\u2019s approval before moving to\n\n Part 2 of the Phase 3 trial is not normally required in a Phase 3 trial. Most Phase 3 trials run straight\n\n through.\n\n 58. The FDA did not give Telix approval for a full Phase 3 trial. Nonetheless,\n\n Defendants repeatedly represented that Telix had approval for a full Phase 3 trial.\n\n 59. For instance, prior to the Class Period, on August 22, 2024, Telix issued a press\n\n release stating: \u201cFor the Phase III ProstACT GLOBAL trial (TLX591), the Investigational New\n\n Drug application was cleared by the U.S. Food and Drug Administration (FDA) and site activation\n\n commenced in the U.S.\u201d Similarly, in the Company\u2019s Form 20-F filed on October 17, 2024 with\n\n the SEC, Telix again told investors it had been approved for a Phase 3 trial in the United States \u2013\n\n without disclosing that only the first part of the Phase 3 trial had been approved.\n 15\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 20 of 90 PageID #:\n 260\n\n\n\n 60. On February 20, 2025, Telix issued a press release announcing its 2024 financial\n\n results and achievements, held a conference call for investors, and publicly released its 2024\n\n Annual Report. In all three, Telix falsely and/or misleadingly asserted it had been authorized to\n\n proceed with its Phase 3 ProstACT Global trial of TLX591, without disclosing that the FDA\u2019s\n\n approval had been limited to Part 1 of the trial. These statements are detailed infra at Section V.\n\n 61. On February 24, 2025, Telix filed its 2024 Form 20-F annual report with the SEC,\n\n and again falsely and/or misleadingly asserted it had been authorized to proceed with a Phase 3\n\n trial of TLX591.\n\n 62. On February 25, 2025, just two days before Telix\u2019s co-founders sold four million\n\n shares, Telix issued a press release titled \u201cRecruitment Spotlight: Phase 3 Clinical Trial of Novel\n\n Prostate Cancer Radiopharmaceutical Now Active in Miami.\u201d The press release stated:\n\n Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company)\n announces that the Biogenix Molecular Research Center in Miami, FL, is recruiting\n and dosing patients in the ProstACT Global Phase 3 trial1 of TLX591 for patients\n with advanced prostate cancer, as part of a wider United States (U.S.) roll-out.\n\n ProstACT Global is trialling a promising new treatment option for prostate cancer,\n which is the most commonly diagnosed cancer and the second leading cause of\n cancer-related death for U.S. men. This month, Biogenix Molecular Research\n Center successfully administered two doses of TLX591, 14 days apart, to a local\n Miami-based patient, and continues to recruit eligible patients in the Miami area.\n 1\n ClinicalTrials.gov ID: NCT06520345.\n\n 63. The February 25, 2025, press release misrepresented that the FDA had authorized\n\n a full Phase 3 trial of TLX591, and failed to reveal that the FDA had expressly conditioned Telix\u2019s\n\n ability to proceed to Part 2 of the trial on FDA review and approval of the Part 1 data.\n\n\n\n\n 16\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 21 of 90 PageID #:\n 261\n\n\n\n 3. The Formal SEC Investigation is Revealed; Telix Stock Drops\n Damaging Investors\n\n 64. On July 22, 2025, before the market opened, Telix issued a press release and filed\n\n with the SEC a current report on Form 6-K. Attached to the current report was a copy of the press\n\n release. In pertinent part, it stated the following:\n\n Telix has received a subpoena from the [SEC] seeking various documents and\n information primarily relating to the Company\u2019s disclosures regarding the\n development of the Company\u2019s prostate cancer therapeutic candidates.\n\n The Company is fully cooperating with the SEC and is in the process of responding\n to the information request. At this stage, this matter is a fact-finding request. The\n Company has elected to notify the Australian Securities and Investments\n Commission of the SEC\u2019s information request. Telix\u2019s policy is not to discuss any\n details of an ongoing regulatory inquiry.\n\n ***\n\n While the matter is ongoing, Telix will continue with its clinical development\n programs relating to its prostate cancer therapy candidates, in the ordinary course\n of business. The information requested does not extend to Telix\u2019s commercial and\n late-stage precision medicine products including Illuccix, Gozellix, Zircaix,\n Pixclara and Scintimun\u00ae[.]\n\n 65. On July 22, 2025, after market close, Bloomberg published an article entitled \u201cTelix\n\n Shares Drop as SEC Probes Disclosures Tied to Prostate Cancer Drug Pipeline.\u201d This article stated\n\n that \u201c[Telix] slumped as much as 16%, the most in 21 months, after the Australian developer of\n\n radioactive drugs said it received a subpoena from the [SEC] seeking information about disclosures\n\n related to its prostate cancer therapeutic candidates.\u201d\n\n 66. The market understood the SEC\u2019s investigation and subpoena to concern Telix\u2019s\n\n disclosures regarding the development of its prostate cancer therapeutic candidate TLX591.\n\n 67. The fact that the SEC served a subpoena upon Telix indicates the SEC was not\n\n merely conducting an informal inquiry but had commenced a formal investigation. The SEC\n\n\n 17\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 22 of 90 PageID #:\n 262\n\n\n\n cannot issue subpoenas without a formal order of investigation. A formal order of investigation\n\n necessarily means the SEC has reason to believe Telix may have violated federal securities law.\n\n 68. On this news, Telix ADSs fell $1.70/ADS, or 10.4%, to close at $14.58 on July 23,\n\n 2025. The next day, Telix ADSs fell a further $0.69/ADS, or 4.7%, to close at $13.89 on July 24,\n\n 2025.\n\n 69. Defendants did not correct the record in July 2025 by publicly and clearly\n\n disclosing that the FDA had only authorized Part 1 of the Phase 3 trial.\n\n 4. The Aftermath of the Announced SEC Investigation\n\n 70. Telix did not immediately correct investors\u2019 confusion over the need for FDA\n\n approval to proceed to Part 2 of the ProstACT Global Phase 3 trial. After the Class Period, on\n\n December 8, 2025, Telix issued a press release titled \u201cProstACT Global Phase 3 Update: First\n\n Patient Dosed in Randomized Treatment Expansion, Part 1 Readout Plans Confirmed.\u201d The press\n\n release explained that Telix was going forward with Part 2 of the trial in certain countries but could\n\n not proceed to Part 2 in the United States. The press release further stated: \u201cAs previously agreed\n\n with FDA and disclosed to the market, Telix will submit Part 1 data to the United States (U.S.)\n\n Food and Drug Administration (FDA) to enable clearance to expand Part 2 of the trial to U.S.\n\n sites. A public disclosure of preliminary results from Part 1 of the study will be aligned to\n\n engagement with the FDA.\u201d\n\n 71. On December 17, 2025, Telix issued a press release titled \u201cProstACT Global Study:\n\n Status,\u201d which stated:\n\n Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, \u201cTelix\u201d) today\n provides an update to confirm the current status of the ProstACT Global Phase 3\n study of its lead prostate cancer therapy candidate TLX591. . . . This announcement\n is provided in response to inaccurate information in market circulation.\n\n ***\n 18\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 23 of 90 PageID #:\n 263\n\n\n\n\n Preparation is now underway to complete data lock and read-out. This includes data\n from each of the three cohorts in Part 1, including the docetaxel cohort which was\n the final cohort to complete enrolment. As previously disclosed[2], data from Part\n 1 will be presented to the United States (U.S) Food and Drug Administration\n (FDA) to ascertain eligibility for U.S. patients to participate in the Part 2\n (randomized treatment expansion) portion of the study. Preliminary results from\n Part 1 of the study will be publicly disclosed at the time of readout and\n engagement with the FDA.\n\n [2] Telix ASX disclosure 8 December 2025.\n\n 72. The Telix December 17, 2025 press release included a footnote referencing the\n\n December 8, 2025 press release as evidence Telix had previously disclosed to the public that the\n\n Company was required to obtain FDA approval before enrolling US patients in Part 2 of the\n\n ProstACT Global phase 3 trial.\n\n 73. On this news, the price of Telix ADSs declined from $8.34 to $7.85, a drop of\n\n nearly 6%.\n\n 74. As of the filing of Telix\u2019s 2025 Annual Report on February 20, 2026, the SEC\n\n investigation is ongoing.\n\n 75. On March 10, 2026, Telix reported the safety and dosimetry data from Part 1 of the\n\n ProstACT Global phase 3 trial and announced: \u201cPart 1 data will be presented to the United States\n\n (U.S.) Food and Drug Administration (FDA) to seek an Investigational New Drug (IND)\n\n amendment to progress Part 2 in the U.S.\u201d\n\n 5. Defendants\u2019 Post-Class Period Statements Prove Class Period\n Statements Were Misleading\n\n 76. A comparison of (i) Defendants\u2019 statements prior to when the SEC issued its\n\n subpoena to (ii) similar statements after the Class Period, demonstrate the misleading nature of\n\n Defendants\u2019 earlier statements.\n\n\n 19\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 24 of 90 PageID #:\n 264\n\n\n\n 77. On February 24, 2025, the Company filed with the SEC its Annual Report on Form\n\n 20-F for the year ended December 31, 2024 (the \u201c2024 Form 20-F\u201d). The 2024 Form 20-F stated\n\n the Company had authority to go forward with a Phase 3 trial of TLX591:\n\n We have not submitted any applications for regulatory approval or obtained\n regulatory approval for any of our therapeutic product candidates. Our most\n advanced therapeutic candidate, TLX591 (177Lu-rosopatamab tetraxetan), is a\n lutetium-labeled radio antibody-drug conjugate, or rADC, which we are evaluating\n in a Phase 3 clinical trial in patients with advanced prostate cancer. We dosed\n the first patient in this clinical trial in November 2023 in Australia. We received\n authorization to conduct the trial in the United States in April 2024 and are\n actively dosing patients at multiple clinical trial sites. We cannot be certain that\n TLX591, or any of our clinical trials of our other therapeutic product candidates,\n will generate safety and efficacy data sufficient for regulatory approval in any\n jurisdiction.\n\n 78. After the Class Period, on February 20, 2026, the Company filed with the SEC its\n\n Annual Report on Form 20-F for the year ended December 31, 2025 (the \u201c2025 Form 20-F\u201d). The\n\n 2025 Form 20-F rewrote that section to indicate the Company only had authority to go forward\n\n with part 1 of the Phase 3 study of TLX591:\n\n We have not submitted any applications for regulatory approval or obtained\n regulatory approval for any of our therapeutic product candidates. Our most\n advanced therapeutic candidate, TLX591-Tx (lutetium (Lu177) rosopatamab\n tetraxetan), is a lutetium-labeled radio antibody-drug conjugate (\"rADC\"), which\n we are evaluating in a two-part Phase 3 clinical trial in patients with advanced\n prostate cancer, called ProstACT Global. We dosed the first patient in this clinical\n trial in November 2023 in Australia. We received authorization to conduct Part 1\n of the trial in the U.S. in April 2024 and completed target enrollment of 30 patients\n in August 2025. We dosed the first patient in ProstACT Global Part 2 (randomized\n treatment expansion) in Australia in December 2025. We cannot be certain that\n TLX591-Tx, or any of our clinical trials of our other therapeutic product candidates,\n will generate safety and efficacy data sufficient for regulatory approval in any\n jurisdiction.\n\n 79. The 2024 Form 20-F stated that Telix would proceed to the second portion of the\n\n Phase 3 ProstACT Global trial after finishing the first part, without any reference to the required\n\n FDA approval to do so.\n\n 20\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 25 of 90 PageID #:\n 265\n\n\n\n We are also investigating TLX591 in the Phase 3 ProstACT GLOBAL clinical trial.\n We expect this trial to enroll 30 patients in a dosimetry and safety lead-in portion\n in replicating the prior study using the product candidate specifications intended\n for commercial release and then proceed to a randomized treatment expansion\n portion, in up to approximately 490 patients. The trial is a multi-national, multi-\n center, prospective, randomized, controlled, open label study designed to\n investigate and confirm the benefits and risks associated with TLX591 a high-\n affinity PSMA-targeted rADC that delivers DNA breaking radiation directly to\n PSMA-positive bone, nodal, or visceral metastases in patients with mCRPC. The\n trial will enroll patients that have PSMA-positive mCRPC who have experienced\n disease progression following treatment with an androgen receptor pathway\n inhibitor (abiraterone or enzalutamide) that was received in either the metastatic\n castration-sensitive prostate cancer or first-line mCRPC treatment setting. The\n primary endpoint of the randomized portion of the trial is radiographic progression-\n free survival and secondary endpoints include overall survival, objective response\n rate, time to first symptomatic skeletal events, PFS, PSA decline of more than 50%,\n quality of life and safety and tolerability.\n\n 80. After the Class Period, the 2025 Form 20-F clearly indicated Telix could not\n\n proceed to a randomized treatment expansion portion in Part 2 of the trial without first getting\n\n FDA approval:\n\n ProstACT Global is a randomized, multinational, multicenter, open-label Phase 3\n trial for the treatment of PSMA-positive mCRPC patients in combination with the\n standard of care, compared to the standard of care alone. In August 2025, Part 1 of\n this trial, a dosimetry and safety lead-in portion, completed target enrollment of 30\n patients. The results will be presented to the FDA to obtain their agreement for\n the commencement of the randomized treatment expansion arm (Part 2), in the\n U.S. Part 2 already has regulatory approvals to commence in Australia, Canada,\n China, New Zealand, Singapore, South Korea, T\u00fcrkiye and the United Kingdom.\n We dosed the first patients in Part 2 in Australia in December 2025, and are actively\n dosing patients at multiple clinical trial sites outside the U.S.\n\n 81. Unlike the 2025 Form 20-F, the 2024 Form 20-F did not disclose to investors that\n\n the FDA had only authorized Telix to proceed with Part 1 of the ProstACT Global trial of TLX591.\n\n 82. As is detailed infra at \u00a7 V, Defendants made a number of false and misleading\n\n statements misrepresenting and/or implying that Telix had been authorized by the FDA to conduct\n\n the full Phase 3 ProstACT Global trial of TLX591.\n\n\n 21\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 26 of 90 PageID #:\n 266\n\n\n\n 83. Only after the SEC issued a formal subpoena to Telix regarding its statements to\n\n the public about the TLX591 trials, did the Defendants attempt in earnest to fix the false impression\n\n created by their misleading statements.\n\n D. Telix Misrepresents TLX250 (Kidney Agent) Risks\n\n 1. Background - First FDA Rejection\n\n 84. TLX250-CDx (Zircaix) is used for kidney cancer imaging. TLX250 combines an\n\n antibody (girentuximab) and an isotope (Zirconium89) to enable the antibody to find and bind to\n\n a protein (CAIX) on kidney cancer cells, with the isotope on the kidney cancer cells being visible\n\n on a PET scan.\n\n 85. In May 2024, prior to the Class Period, Telix submitted a biologics license\n\n application (\u201cBLA\u201d) to the FDA for TLX250-CDx (Zircaix). In July 2024, the FDA declined to\n\n review the BLA and issued a Refuse to File (\u201cRTF\u201d) determination (the \u201cFirst RTF\u201d). An RTF\n\n determination is a response from the FDA following its preliminary review, communicating the\n\n FDA\u2019s determination that the application does not include all pertinent information and data. The\n\n FDA\u2019s denial of acceptance for filing was based on a filing concern related to demonstrating\n\n adequate sterility assurance during dispensing of TLX250 in the radiopharmacy production\n\n environment.\n\n 86. Telix\u2019s July 31, 2024 press release indicated the FDA \u201cidentified a filing issue in\n\n the Chemistry, Manufacturing and Controls (CMC) package. The specific filing concern relates to\n\n demonstrating adequate sterility assurance during dispensing of TLX250-CDx in the\n\n radiopharmacy production environment.\u201d The press release continued:\n\n Dr Christian Behrenbruch, Managing Director and Group Chief Executive Officer\n at Telix, stated, \u201cTLX250-CDx is a breakthrough product and, if approved, would\n be the first targeted imaging agent for the non-invasive detection of renal cancer.\n We have been working closely with the FDA through the BLA rolling review due\n 22\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 27 of 90 PageID #:\n 267\n\n\n\n to the novel nature of this product candidate and value the FDA\u2019s constructive\n feedback at this early stage in the process. We expect to be able to satisfy its\n requirements within a minimal time frame and continue to see a clear path to\n product commercialisation in 2025.\u201d\n\n 2. Defendants Ignore the FDA\u2019s Recommendations\n\n 87. After the FDA rejected Telix\u2019s first BLA for TLX250, Telix had an opportunity to\n\n correct deficiencies discovered by the FDA. Telix did not do so.\n\n 88. According to FE-1, the FDA issued the First RTF in July 2024 because Telix did\n\n not have results for a sterility test of the antibody at the time of submission. Telix was still\n\n conducting the relevant sterility test, but Defendant Behrenbruch insisted that Telix submit the\n\n BLA anyway. The sterility test ultimately failed and the FDA cited it as the reason for the First\n\n RTF.\n\n 89. By the time Telix resubmitted the BLA for TLX250 in December 2024, the sterility\n\n test issue was addressed and the results were successful. This corrected the reason for the First\n\n RTF. However, when the FDA issued the First RTF in July 2024, the FDA also provided a list of\n\n other items that did not cause the RTF but were items the FDA suggested Telix address before\n\n resubmission.\n\n 90. According to FE-1, Telix did not address all of the FDA\u2019s recommendations prior\n\n to the resubmission December 2024.\n\n 3. Prior to Resubmission in December 2024, Telix Employees Presented\n Behrenbruch with a List of the Risks to FDA Approval\n\n 91. After the FDA rejected Telix\u2019s first BLA for TLX250 in July 2024, Telix had an\n\n opportunity to address risks raised by the Company\u2019s employees. Telix did not do so.\n\n 92. In late-2024, Telix employees created a list of top risks to FDA approval of\n\n TLX250. Before Telix resubmitted the BLA in late 2024, FE-1 attended a meeting at which Telix\n\n 23\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 28 of 90 PageID #:\n 268\n\n\n\n VP and President of Global Drug Development Habi Soulaihi presented these risks to Defendant\n\n Behrenbruch. Telix COO Darren Patti and Telix Group Drug Chief Medical Officer David Cade\n\n were also in attendance, as well as other senior Telix employees.\n\n 93. One of the main risks identified on the list presented to Defendants Behrenbruch at\n\n this meeting was the existence of particulates within the liquid product to be administered to\n\n patients. \u201cThe particulates were always a top one [risk] we were worried about,\u201d according to FE-\n\n 1. \u201cYou can\u2019t have visible particulates in an injectable product.\u201d\n\n 94. Telix had uncovered the existence of the particulates in the solution in the first half\n\n of 2024, according to FE-1.\n\n 95. According to FE-1, the particulates risk was heightened because Telix had changed\n\n the process by which it manufactured TLX250 for commercial use compared to what it used for\n\n the clinical trial. \u201cIt was a new development as a result of the formulation change. The process\n\n changes created it.\u201d\n\n 96. Once the particulates were discovered in the first half of 2024, according to FE-1,\n\n Telix leadership decided the particulates would not be a concern for patients. Top leadership\n\n decided they would deal with the particulates by changing the description of the product\u2019s\n\n appearance in its BLA filing. In the earlier Investigational New Drug filing for the Company\u2019s\n\n clinical trials of TLX250-CDx, the product\u2019s \u201cappearance specification\u201d did not allow for\n\n particulates, and the product was described as a completely clear liquid. In the BLA filing, Telix\n\n changed the \u201cappearance specifications\u201d to now allow for a certain amount of particulates that are\n\n \u201cinherent to the product.\u201d\n\n 97. Clinical trials are designed to make sure a drug product is safe for the population\n\n that will be using that drug. When, as is the case here, the drug that is to be used by the general\n\n 24\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 29 of 90 PageID #:\n 269\n\n\n\n population is somehow different than the drug that was tested in the clinical trials, there is an\n\n obvious red flag regarding whether the clinical trial data on safety can still be relied upon.\n\n 98. According to FE-1, one of the FDA\u2019s primary concerns and bases for rejecting\n\n TLX250 was patient safety related to these visible particulates in the injectable solution,\n\n particularly because the product was different than what had been used in the trials.\n\n 99. Another of the main risks identified on the list presented to Defendant Behrenbruch\n\n was the quality of the zirconium provided by a third-party manufacturer named 3DI. That risk\n\n remained on the list through the FDA\u2019s review of TLX250, according to FE-1. The Telix team that\n\n put together the risks list thought Telix did not have sufficient tests to prove the quality of the\n\n Zirconium to the FDA. This risk was difficult for Telix to address because \u201cthe 3DI owner didn\u2019t\n\n want to do anything additional,\u201d according to FE-1.\n\n 100. According to FE-1, Defendant Behrenbruch simply dismissed these risks: \u201cChris\n\n would justify them himself, [saying] Oh, it\u2019s ok. It\u2019s fine. It\u2019s fine.\u201d \u201cIt didn\u2019t matter what we\n\n said.\u201d \u201cHe was going to say push forward. Don\u2019t worry about it. It\u2019s fine. It was a strange way to\n\n operate.\u201d These risks ultimately resulted in the FDA\u2019s rejection of the TLX250 BLA in August\n\n 2025\n\n 4. Telix Resubmits the TLX250 BLA (Kidney Agent)\n\n 101. Despite not correcting deficiencies previously discovered by the FDA or addressing\n\n significant risks identified by its employees, Telix resubmitted its TLX250 BLA to the FDA in\n\n December 2024.\n\n 102. Defendants knew these risks when the Company resubmitted its BLA in late 2024.\n\n Telix announced the resubmission in a press release on December 30, 2024, but failed to disclose\n\n these material facts to investors.\n\n 25\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 30 of 90 PageID #:\n 270\n\n\n\n 103. On February 26, 2025, Telix issued a press release announcing the FDA had\n\n accepted its BLA for TLX250. The press release was effusive in its praise for TLX250. It stated:\n\n Telix today announces that the United States (U.S.) Food and Drug Administration\n (FDA) has accepted the Biologics License Application (BLA) for its breakthrough\n investigational kidney cancer PET1 imaging agent TLX250-CDx (Zircaix\u00ae2, 89Zr-\n DFO-girentuximab), granted a Priority Review and provided a PDUFA3 date of 27\n August 2025, paving the way for a U.S. commercial launch in 2025.\n\n If approved, TLX250-CDx will become the first commercially available imaging\n agent to accurately and non-invasively diagnose and characterize clear cell renal\n cell carcinoma (ccRCC), the most common and one of the most aggressive sub-\n types of kidney cancer. It works by specifically binding to carbonic anhydrase IX\n (CAIX), a validated target protein expressed on 95% of ccRCC cells to produce\n images with high tumor-to-background ratio and high intra- and inter-reader\n consistency.\n\n The BLA is based on Telix\u2019s successful global Phase 3 ZIRCON4 study, which\n demonstrated a sensitivity of 86%, specificity of 87% and a positive predictive\n value (PPV) of 93% for ccRCC, including in very small, difficult-to-detect lesions5.\n The results of this study were published in The Lancet Oncology in September\n 2024, in a peer-reviewed manuscript by Professor Brian Shuch (University of\n California, Los Angeles, UCLA) and colleagues6. The paper outlines the critical\n unmet need for a new, non-invasive technique that can accurately detect and\n differentiate ccRCC from other renal masses in patients and concluded that\n TLX250-CDx meets this need and \u2018has the potential to be practice changing.\u2019\n\n Kevin Richardson, Chief Executive Officer, Precision Medicine, said, \u201cWe are\n delighted that the FDA has accepted this BLA as it moves us one step closer to\n bringing our breakthrough product to patients. We are aiming to revolutionize\n the management of kidney cancer, just as PSMA-PET/CT7 scanning has changed\n the management of prostate cancer. By providing a more definitive clinical\n diagnosis for renal masses, we believe that Zircaix2 will help physicians make more\n timely and confident patient management decisions and more quickly provide\n patients with a clear understanding of their disease and treatment options. Building\n further on Telix\u2019s successful urology franchise, we are preparing to bring this\n powerful precision medicine product to market in 20258.\u201d\n 1\n Positron emission tomography.\n 2\n Brand name subject to final regulatory approval.\n 3\n Prescription Drug User Fee Act.\n 4\n Zirconium in Renal Cancer Oncology, ClinicalTrials.gov ID: NCT03849118.\n 5\n Telix ASX disclosures 7 November 2022.\n 6\n Shuch et al. Lancet Oncology. 2024.\n\n 26\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 31 of 90 PageID #:\n 271\n\n\n 7\n Imaging of prostate-specific membrane antigen with positron emission\n tomography/computed tomography.\n 8\n Subject to regulatory approval.\n\n 104. Telix did not disclose the FDA-identified issues or employee-identified risks in its\n\n press release. The FDA\u2019s acceptance of the BLA had not \u201cpaved the way for a U.S. commercial\n\n launch in 2025\u201d because, as Defendants knew, the BLA suffered from material deficiencies.\n\n 105. On the next day, Telix\u2019s co-founders would sell four million shares of Telix stock\n\n at a price double the value after the truth was disclosed.\n\n 5. The Second FDA Rejection of TLX250 (Kidney Agent)\n\n 106. On the last day of the Class Period August 28, 2025, Telix posted an announcement\n\n on its website informing investors that the FDA had once again rejected its BLA for TLX250 in\n\n the form of a Complete Response Letter. The press release was entitled \u201cTelix Provides Regulatory\n\n Update on TLX250-CDx.\u201d It stated the following:\n\n Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, \u201cTelix\u201d) today\n announces that it has received a Complete Response Letter (CRL) from the United\n States (U.S.) Food and Drug Administration (FDA) for the Biologics License\n Application (BLA) for TLX250-CDx (Zircaix\u00ae1, 89Zr-DFO-girentuximab), an\n investigational PET2 agent for the diagnosis and characterization of renal masses\n as clear cell renal cell carcinoma (ccRCC).\n\n The CRL identifies deficiencies relating to the Chemistry, Manufacturing, and\n Controls (CMC) package. The FDA has requested additional data to establish\n comparability between the drug product used in the ZIRCON Phase 3 clinical\n trial and the scaled-up manufacturing process intended for commercial use.\n Additionally, the FDA has documented notices of deficiency (Form 483) issued to\n two third-party manufacturing and supply chain partners that will require\n remediation prior to resubmission.\n 1\n Brand name subject to final regulatory approval.\n 2\n Position emission tomography.\n\n\n\n\n 27\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 32 of 90 PageID #:\n 272\n\n\n\n 107. On this news, the price of Telix ADSs fell $1.95 per ADS, or 16.1%, to close at\n\n $10.15 on August 28, 2025. The next day, Telix ADSs fell a further $0.60 per ADS, or 5.9%, to\n\n close at $9.55 on August 29, 2025.\n\n 108. The two third-party manufacturing and supply chain partners \u2013 whose identities\n\n were not publicly disclosed in the press release \u2013 were 3D Imaging Drug Design and Development\n\n (\u201c3DI\u201d) and Goodwin Biotechnology Inc. (\u201cGBI\u201d).\n\n 109. According to Telix, the FDA rejected the TLX250 BLA for two main reasons (i)\n\n comparability, and (ii) the deficiencies at its third-party manufacturers. The FDA\u2019s rejection of the\n\n TLX250 BLA was not a surprise to Defendants, however, as they had known during the Class\n\n Period about the very problems the FDA cited as the basis for its rejection. These were the very\n\n same issues which Telix VP and President of Global Drug Development Habi Soulaihi had\n\n presented to Defendant Behrenbruch, and which (as detailed infra) Telix had been dealing with\n\n for some time.\n\n 6. Telix Knew it had a Comparability Problem Between the Trial Drug\n and Commercial Product, Highlighted by Particulates in the Solution\n\n 110. The version of TLX250-CDx used in the clinical trials was not manufactured the\n\n same way as the version of TLX250-CDx that Telix planned to sell commercially. This change\n\n was made prior to submitting the first BLA in May 2024.\n\n 111. According to FE-1, when a drug company changes the manufacturing process for\n\n its commercial product from how it was made for use in the clinical trials, the FDA closely\n\n scrutinizes the comparability of the commercial product to the drug used in the clinical trials to\n\n ensure patients will receive the same product that was tested in trials.\n\n\n\n\n 28\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 33 of 90 PageID #:\n 273\n\n\n\n 112. Therefore, according to FE-1, making a manufacturing change between clinical and\n\n commercial use makes the Chemistry Manufacturing & Controls (or \u201cCMC\u201d) part of BLA review\n\n more difficult.\n\n 113. Telix changed the way TLX250-CDx was manufactured when it was scaled up\n\n from production for clinical use to production for commercial use.\n\n 114. Consequently, the FDA wanted sufficient data from Telix to prove that the product\n\n made for commercial use was comparable to the product that was used in clinical trials.\n\n 115. According to FE-1, Telix began receiving significant Information Requests (\u201cIRs\u201d)\n\n from the FDA indicating the agency\u2019s concerns about comparability issues in February 2025. The\n\n FDA\u2019s core focus of its questions and ongoing concerns was comparability issues that were\n\n eventually cited as a reason for the CRL.\n\n 116. FE-1 stated: \u201cI think their initial concern that never went away was the original\n\n Phase 3 trial for Zircaix was executed with a certain product profile and a lot of changes were\n\n made to get the product ready for commercialization after that Phase 3 trial.\u201d \u201cThat\u2019s a tough one\n\n because the FDA wants comparability [data] to show what you\u2019re coming to market with\u2026is\n\n essentially the same.\u201d\n\n 117. In this case, the need for data demonstrating comparability was particularly acute.\n\n According to FE-1, as part of its comparability review, the FDA had patient safety concerns about\n\n particulate matter that was found in the product manufactured for commercial use. The FDA asked\n\n Telix to do a number of tests to prove what the particulates were, what was causing them, and that\n\n they were fully filtered out of the solution at the point of injection in patients.\n\n 118. The issue of particulates in the solution was the same problem identified and\n\n presented to Defendant Behrenbruch prior to the resubmission in December 2024.\n\n 29\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 34 of 90 PageID #:\n 274\n\n\n\n 119. Telix attempted to assuage the FDA by explaining that the particulates were filtered\n\n out of the product at the clinics where the product was injected into patients for imaging scans.\n\n According to FE-1, Telix \u201ctried to demonstrate with some studies that the filter [at the clinics] was\n\n removing [the particulates] and there was no risk to patients.\u201d The FDA was not satisfied with the\n\n studies Telix presented, particularly because the product to be sold commercially was\n\n manufactured differently than the one used in clinical trials.\n\n 120. Telix presented the FDA with analytical studies comparing the clinical and\n\n commercial version of TLX250, but the data was not conclusive enough for the FDA.\n\n 121. According to FE-1, in April or May 2025 the FDA told Telix to perform a\n\n statistically significant human trial to prove comparability. In May 2025, FE-1 told Telix Group\n\n Chief Operating Officer Darren Patti that Telix would have to do statistically significant human\n\n trials, as requested by the FDA. \u201cI was trying to be very clear with them that we weren\u2019t going to\n\n get there [with the analytical comparison,] that we were going to need the clinical study.\u201d Patti\n\n conveyed this message to CEO Behrenbruch.\n\n 122. Though the FDA did not request the human study until April or May 2025, Telix\n\n realized all along that they could have to do such a statistically significant human study. Indeed,\n\n Telix had already begun a human study to prove comparability before the FDA requested it. But\n\n the study that Telix was conducting was too small (only 10 to 12 patients) to satisfy the FDA\u2019s\n\n requirement that the study be statistically significant. This posed a real problem for Telix.\n\n According to FE-1, a statistically significant study would require 80 patients and that would take\n\n a longer time and could not be completed before the August 2025 PDUFA date.\n\n 123. Defendant Behrenbruch was adamant that Telix not agree to the FDA\u2019s request to\n\n perform a statistically significant human study to prove comparability. According to FE-1, Telix\n\n 30\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 35 of 90 PageID #:\n 275\n\n\n\n pushed back on the FDA\u2019s request. From the moment the FDA requested the statistically\n\n significant human study in April or May 2025, Behrenbruch was adamant that Telix not do one.\n\n Behrenbruch \u201cwas kind of trying to put his foot down on what he would allow the team to do \u2013\n\n that somehow we\u2019d be able to convince the FDA\u201d that the larger trial wasn\u2019t necessary. Telix\n\n senior management simply refused to do the statistically significant human trial because it would\n\n be impossible to do so before the PDUFA date in August 2025.\n\n 124. Ultimately, in June 2025 Telix met with the FDA for the Late-Cycle Review\n\n Meeting, which FE-1 attended along with Defendant Behrenbruch. During this meeting, the FDA\n\n once again expressed its ongoing concerns about the comparability data, the patient safety issues\n\n related to the particulates, and deficiencies found during the pre-approval inspections of GBI and\n\n 3DI (all of which are detailed infra). It was clear that the FDA would not approve TLX250.\n\n 125. The Complete Response Letter for TLX250-CDx (the \u201cTLX250 CRL\u201d) was not\n\n made publicly available until an edited and redacted version of it was published on the FDA\u2019s\n\n website on or about April 23, 2026, in response to Lead Counsel\u2019s FOIA request to the FDA. A\n\n copy of the TLX250 CRL is attached hereto as Exhibit B. The TLX250 CRL confirms the account\n\n of FE-1.\n\n 7. Telix Knew of the Problems at GBI\n\n 126. The FDA ultimately rejected the TLX250-CDx (Zircaix) (Kidgney Agent) BLA for\n\n several reasons, one of which was deficiencies found at third-party manufacturers. One of those\n\n third-party manufacturers was GBI.\n\n 127. Telix contracted with Goodwin Biotechnology Inc. (\u201cGBI\u201d) in Plantation, Florida\n\n to manufacture the bioconjugator or \u201cchelator\u201d for TLX250-CDx, which worked to bind the\n\n isotope to the antibody.\n\n 31\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 36 of 90 PageID #:\n 276\n\n\n\n 128. According to FE-1, GBI had never been inspected or approved by the FDA to\n\n manufacture products for commercial use. Knowing that GBI had not ever passed a pre-approval\n\n inspection by the FDA, Telix hired a third party to conduct a mock FDA inspection at the facility.\n\n 129. According to FE-1, the mock inspection occurred at the end of 2024, and identified\n\n a number of deficiencies. Telix\u2019s mock-inspectors \u201cdiscovered a pretty long list of concerns\u201d and\n\n GBI only made a \u201cwishy-washy commitment\u201d to fix them.\n\n 130. FE-1 recalled that there was an email about the mock inspection results that was\n\n circulated internally at Telix, which Defendant Behrenbruch received and later referenced in a\n\n meeting attended by FE-1.\n\n 131. After the mock inspection and GBI\u2019s lackluster response, FE-1 and her team\n\n recommended to top Telix leadership, including Defendant Behrenbruch, that they find a back-up\n\n manufacturer. According to FE-1: \u201cThe feedback I got was, Chris said no, make it work with these\n\n guys.\u201d\n\n 132. GBI never satisfactorily addressed the issues discovered in the mock audit. \u201cThey\n\n weren\u2019t really working on the systematic issues,\u201d FE-1 said. \u201cThey were fixing things on the\n\n surface here and there.\u201d FE-1 said Telix was keeping track of GBI\u2019s efforts in early 2025 and was\n\n aware that the problems persisted, which is why FE-1 recommended finding another manufacturer\n\n as a back-up.\n\n 133. It wasn\u2019t just FE-1 voicing concerns. The head of quality and the rest of the quality\n\n department were also worried about GBI. The head of the quality department briefed Darren Patti,\n\n Group Chief Operating Officer, on a regular basis. Patti reported to CEO Behrenbruch on a weekly\n\n basis about the issues at GBI.\n\n\n\n 32\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 37 of 90 PageID #:\n 277\n\n\n\n 134. From May 13-16, 2025, the FDA conducted a pre-approval inspection at GBI in\n\n Plantation, FL, as part of the BLA for TLX250-CDx.\n\n 135. The FDA issued a Form 483 listing the deficiencies found during that inspection to\n\n GBI on May 16, 2025. A redacted copy of that Form 483, obtained via a FOIA request, is attached\n\n as Exhibit C.\n\n 136. Telix received the Form 483 from GBI shortly after it was issued. According to FE-\n\n 1, the FDA findings in the Form 483 included multiple deficiencies identified by Telix in its mock\n\n inspection of GBI in 2024.\n\n 137. In June 2025 Telix met with the FDA for the Late-Cycle Review Meeting, which\n\n FE-1 attended along with Defendant Behrenbruch. During this meeting, the FDA indicated it could\n\n not approve TLX250 until, among other things, GBI passed a follow-up inspection to show it had\n\n corrected the deficiencies cited in the Form 483. According to FE-1: \u201cThe FDA was clear in the\n\n June meeting that successful inspections at the manufacturers were required for approval.\u201d It was\n\n also clear that there was not enough time for the re-inspection of GBI to occur before the August\n\n 2025 PDUFA date.\n\n 138. After the FDA issued the Form 483 to GBI, and GBI was given time to respond in\n\n writing, the FDA issued an Establishment Inspection Report (EIR) on October 16, 2025. The\n\n October 2025 EIR provides more details about the inspection and the deficiencies found. A\n\n redacted copy of the October 2025 EIR, obtained via a FOIA request, is attached as Exhibit D.\n\n 8. Telix Knew of the Problems at 3DI\n\n 139. The FDA ultimately rejected the TLX250-CDx (Zircaix) (Kidgney Agent) BLA for\n\n several reasons, one of which was deficiencies found at third-party manufacturers. One of those\n\n third-party manufacturers was 3DI.\n\n 33\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 38 of 90 PageID #:\n 278\n\n\n\n 140. Telix contracted with 3D Imaging Drug Design and Development (\u201c3DI\u201d) to\n\n manufacture the radioisotope zirconium-89 that is used in TLX250-CDx.\n\n 141. According to FE-1, as described supra in Section IV.D.3., in late 2024 Telix\n\n employees created a list of top risks to FDA approval of TLX250 that was presented to Defendant\n\n Behrenbruch. One of the main risks identified was the quality of the zirconium provided by 3DI.\n\n That risk remained throughout the BLA review period because \u201cthe 3DI owner didn\u2019t want to do\n\n anything additional\u201d to address Telix\u2019s quality concerns, according to FE-1. The risk \u201cdidn\u2019t get\n\n addressed. It remained a top risk that was always out there.\u201d\n\n 142. Telix did not disclose that it relied upon 3DI to obtain Zirconium for TLX250-CDx.\n\n Rather, Telix referenced different suppliers. On February 24, 2025, Telix filed its Form 20-F with\n\n the SEC, in which Telix indicated its \u201caim to continue to deepen our relationship with key\n\n manufacturing networks in the United States\u201d for Zirconium, specifically naming Pharmalogic and\n\n Cardinal Health. This statement was false and misleading.\n\n 143. 3DI had previously been issued Form 483 citations by the FDA in 2019 and 2024.\n\n 144. From June 9-13, 2025, the FDA conducted a pre-approval inspection at 3DI in Little\n\n Rock Arkansas, as part of the BLA for TLX250-CDx.\n\n 145. The FDA issued a Form 483 listing the deficiencies found during that inspection to\n\n 3DI on June 13, 2025. A redacted copy of that Form 483, obtained via a FOIA request, is attached\n\n as Exhibit E.\n\n 146. According to FE-1, Telix learned of the FDA inspection of 3DI and Telix received\n\n a summary of the Form 483 shortly after the FDA closed the inspection in June 2025.\n\n 147. The Form 483 noted a number of deficiencies and found that the facility was not\n\n compliant with standards governing commercial manufacturing of radiopharmaceuticals.\n\n 34\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 39 of 90 PageID #:\n 279\n\n\n\n 148. According to FE-1, 3DI was \u201ca small outfit run by one guy\u201d and he was not willing\n\n to make all of the changes requested by the FDA to bring 3DI\u2019s manufacturing process into\n\n compliance. This was a serious problem for Telix\u2019s ability to obtain approval of TLX250-CDx.\n\n 149. In June 2025 Telix met with the FDA for the Late-Cycle Review Meeting, which\n\n FE-1 attended along with Defendant Behrenbruch. During this meeting, the FDA indicated it could\n\n not approve TLX250 until, among other things, 3DI passed a follow-up inspection to show it had\n\n corrected the deficiencies cited in the Form 483. According to FE-1: \u201cThe FDA was clear in the\n\n June meeting that successful inspections at the manufacturers were required for approval.\u201d It was\n\n also clear that there was not enough time for the re-inspection of 3DI to occur before the August\n\n 2025 PDUFA date.\n\n 150. Ultimately, 3DI did not address all of the FDA\u2019s concerns. After 3DI had an\n\n opportunity to respond to the FDA\u2019s Form 483 findings in writing, the FDA issued 3DI a Warning\n\n Letter in December 2025. Lead Counsel has requested that Warning Letter from the FDA but has\n\n not yet received a response.\n\n 151. Defendants made numerous false and misleading statements about TLX250-CDx\n\n (Zircaix) during the Class Period that omitted to disclose that Telix relied upon 3DI as a third-\n\n party manufacturer even though Defendants had substantial concerns about the quality of the\n\n zirconium from 3DI and knew about the FDA\u2019s findings of material deficiencies at 3DI. The FDA\n\n ultimately rejected the TLX250-CDx (Zircaix) BLA because of, among other things, the\n\n deficiencies at 3DI and this came as no surprise to Defendants.\n\n\n\n\n 35\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 40 of 90 PageID #:\n 280\n\n\n\n 9. Telix is Still Working to Address the FDA\u2019s Concerns\n\n 152. On February 20, 2026, Telix filed its annual Form 20-F for 2025 with the SEC (the\n\n \u201c2025 Form 20-F\u201d) revealing that the Company has not yet been able to address the FDA\u2019s\n\n concerns from the prior TLX250 BLA submission. The 2025 Form 20-F stated:\n\n In December 2024 we resubmitted our BLA to the FDA for TLX250-Px, and the\n FDA accepted our application in February 2025. In August 2025, the FDA issued\n a Complete Response Letter (\u201cCRL\u201d) citing deficiencies relating to the Chemistry,\n Manufacturing, and Controls (\u201cCMC\u201d) package. The FDA requested additional\n data to establish comparability between the drug product used in the ZIRCON\n Phase 3 clinical trial and the scaled-up manufacturing process intended for\n commercial use. Additionally, the FDA documented notices of deficiency (Form\n 483) issued to two third-party manufacturing and supply chain partners that\n required remediation prior to resubmission. In December 2025 we participated in a\n Type A meeting with the FDA to align on plans to address CMC deficiencies cited,\n and in January 2026 we participated in an additional Type A meeting to align on\n plans to address comparability between the clinical drug product and that intended\n for commercial use. Following these meetings, Telix believes it has alignment with\n the Agency on key resubmission aspects, and is working both internally and with\n third-party vendors to implement these items for resubmission. While we believe\n that the planned remediation of the BLA for TLX250-Px will meet FDA\n requirements, there can be no assurance that, once resubmitted, the FDA will\n accept our BLA for review, or approve TLX250-Px.\n\n 153. The fact that Telix still has not been able to fix the problems with the TLX250-CDx\n\n BLA \u2013 first submitted to the FDA in May 2024 and again in December 2024, illustrates the\n\n materiality and the seriousness of the problems with the BLA identified by Telix employees and\n\n brought to Defendant Behrenbruch\u2019s attention multiple times, but which he refused to disclose to\n\n investors even though he sold 2 million of his shares at the peak of the stock price.\n\n E. The \u201cPump-and-Dump\u201d Scheme\n\n 154. Defendants made false and misleading statements enabling the Company\u2019s co-\n\n founders to sell four million shares of their personal holdings at artificially inflated prices far in\n\n excess of the Company\u2019s true value once the truth about Telix\u2019s pipeline of new drugs became\n\n known publicly.\n 36\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 41 of 90 PageID #:\n 281\n\n\n\n 155. On February 20, 2025, Telix\u2019s common stock on the Australian stock market closed\n\n at $26.46 (Australian) and Telix\u2019s ADSs traded in America closed at $17.41 (American). After the\n\n stock market closed, Telix issued a press release announcing its full year 2024 financial results\n\n and reporting on its \u201ckey achievements.\u201d Telix then held a conference call for investors and\n\n analysts to elaborate on these \u201ckey achievements.\u201d Telix also published its 2024 Annual Report\n\n on its website.\n\n 156. The market reaction to the press release, conference call, and 2024 Annual Report\n\n was overwhelmingly positive. On February 21, 2025, Telix common stock closed at $30.12\n\n (Australian) and its ADSs closed at $19.50 (American). The next trading day was February 24,\n\n 2025, as markets were closed for the weekend, and Telix ADSs closed at $20.93. This was a\n\n significant increase in both the common shares and ADSs resulting from Defendants\u2019 statements.\n\n 157. The positive market reaction was for good reason. Defendants made numerous false\n\n and misleading but glowing statements about the Company\u2019s drug pipeline and manufacturing\n\n capabilities. As detailed further infra at Section V. Defendants\u2019 Misrepresentations, Telix\u2019s\n\n February 20, 2025 press release, conference call, and 2024 Annual Report each contained\n\n misleading statements highlighting the Company\u2019s (i) impending launch of TLX101 (Pixclara),\n\n (ii) Phase 3 trial of TLX591, and (iii) its new drug application for TLX250 (Zircaix).\n\n 158. For example, in the Company\u2019s 2024 Annual Report Defendant Behrenbruch wrote\n\n a letter to shareholders highlighting Telix\u2019s purported accomplishments in 2024, including that\n\n Telix\u2019s \u201cnew drug applications . . . have the potential to significantly impact the standard of care\n\n while super-charging Telix\u2019s cash generation capability[.]\u201d Behrenbruch concluded: \u201cHaving\n\n built a strong foundation over the last few years, and with several major inflection points\n\n achieved in 2024, we are on the cusp of exponential growth.\u201d\n\n 37\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 42 of 90 PageID #:\n 282\n\n\n\n 159. That purported \u201cstrong foundation\u201d was an illusion. The \u201cmajor inflection points\n\n achieved\u201d were not as Defendants represented. Unbeknownst to investors, (i) Defendants already\n\n knew the FDA had found the clinical data submitted in Telix\u2019s new drug application for TLX101\n\n (Pixclara) \u201cdid not provide substantial evidence of effectiveness\u201d (see \u00a7 IV.B.); (ii) the FDA had\n\n not approved a full Phase 3 trial of TLX591, but rather had only approved the first part of a Phase\n\n 3 trial and Defendants\u2019 statements to the contrary would lead to an ongoing formal SEC\n\n investigation (see \u00a7 IV.C.); and (iii) Telix\u2019s Biologics License Application to the FDA for\n\n TLX250-CDx (Zircaix) suffered from multiple defects including that it relied upon third-party\n\n manufacturers Defendants knew did not conform with industry standards that, if discovered by the\n\n FDA, would result in (and did result in) the FDA rejecting the application (see \u00a7 IV.D.).\n\n 160. Analysts didn\u2019t know the truth. They were impressed by Defendants\u2019 statements.\n\n For example, Auerbach Grayson issued an analyst report on February 20, 2025, raising its price\n\n target for Telix common shares 40% to $35 per share Australian. The reason for the price target\n\n increase was directly attributable to Defendants\u2019 false and misleading statements. The analyst\n\n wrote \u201c\u2018de-risking\u2019 the GOZELLIX, PIXCLARA, and ZIRCAIX components all contributed [to\n\n the increased price target]. All three products approach FDA approval with compelling clinical\n\n cases.\u201d With respect to the impact of TLX591 on the price target increase, the Auerbach Grayson\n\n analyst wrote: \u201cConfirmation that US patient enrolment is happening helps firm up timelines for\n\n expected newsflow but more importantly runs counter to the anti-591 narratives that impact\n\n valuation from time to time.\u201d\n\n 161. A few days later, on February 23, 2025, Bell Potter issued an analyst report\n\n upgrading its rating on Telix to buy from hold and raising its price target to $36 per share from\n\n $21.60 per share Australian. The analyst report noted that Telix missed projected earnings but \u201cthe\n\n 38\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 43 of 90 PageID #:\n 283\n\n\n\n market shrugged off the miss in favour of the glowing outlook for acquisition and organic revenue\n\n and earnings growth driven by a rapidly expanding program of therapeutic products to enter the\n\n clinic and imminent likely approvals for Pixclara, Gozellix and potentially Zircaix later in the\n\n year.\u201d\n\n 162. As detailed herein, both Pixclara and Zircaix would not launch in 2025 but be\n\n rejected by the FDA for reasons known to Defendants, and Defendants\u2019 characterizations of the\n\n ProstACT Global trial are under formal SEC investigation for being false and misleading.\n\n 163. On February 25, 2025, Telix issued another very positive press release to announce\n\n that it was \u201crecruiting and dosing patients in the ProstACT Global Phase 3 trial1 of TLX591 for\n\n patients with advanced prostate cancer, as part of a wider United States (U.S.) roll-out.\u201d (omitting\n\n footnote citing the trial protocol). This press release failed to properly disclose that the FDA had\n\n not approved a full Phase 3 trial of TLX591.\n\n 164. The February 25, 2025 press release was calculated merely to pump up the stock\n\n price. Telix had previously disclosed dosing had been ongoing at multiple U.S. sites. See 2024\n\n Form 20-F at 106 (\u201cWe received authorization to conduct the trial in the United States in April\n\n 2024 and are actively dosing patients at multiple clinical trial sites.).\n\n 165. Then, on February 26, 2025, Telix issued two press releases. One announced the\n\n FDA had accepted Telix\u2019s application for TLX250-CDx (Zircaix). Though Defendants knew the\n\n application suffered substantial flaws that put FDA approval in serious jeopardy, Telix\u2019s press\n\n release praised TLX250-CDx (Zircaix) as fulfilling a \u201ccritical unmet need,\u201d a \u201cbreakthrough\n\n product,\u201d and characterized Telix as \u201cpreparing to bring this powerful precision medicine product\n\n to market in 2025.\u201d The FDA would ultimately reject the application for reasons known to\n\n Defendants at the time of the Company\u2019s February 26, 2025 press release.\n\n 39\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 44 of 90 PageID #:\n 284\n\n\n\n 166. Also on February 26, 2025, Telix issued a second press release informing investors\n\n that Telix\u2019s CEO would be selling two million shares of Telix stock.\n\n 167. On February 27, 2025, Telix issued a follow-up press release announcing that\n\n Defendant Behrenbruch and his co-founder Andras Kluge each sold two million Telix shares for\n\n $29.50 per share (in Australian dollars) for a total of $118 million Australian dollars. The private\n\n block sale was conducted at a discount to the closing price of $30.38 on the Australian stock\n\n exchange, as is customary for such large block sales. The closing price and sales price\n\n corresponded to approximately $18.85 to $18.95 and $18.30 to $18.40 American.\n\n 168. When the truth about Telix\u2019s leading pipeline drugs/diagnostics was revealed to\n\n investors, the Company\u2019s common stock price and ADSs collapsed. On August 29, 2025, the day\n\n after the Class Period ended, Telix common stock closed at $14.60 (Australian) and ADSs closed\n\n at only $9.55 (American). Neither the common stock nor ADSs price has recovered.\n\n 169. Had Telix\u2019s co-founders sold these four million shares after the market learned the\n\n truth about the Company\u2019s drug pipeline, they would have recognized approximately half the $118\n\n million Australian dollars they received. The co-founders benefitted significantly from the\n\n Defendants\u2019 pump-and-dump scheme.\n\n 170. Defendant Behrenbruch and his co-founder Andreas Kluge\u2019s stock sales were\n\n unusual in size and timing, and inconsistent with their prior history of trading. A review of Telix\u2019s\n\n SEC filings and website indicates neither Behrenbruch nor Kluge sold a single Telix share or ADS\n\n in 2024 or 2025 other than the block sales on February 27, 2025. On information and belief, the\n\n last time either one had sold any shares was January 27, 2022.\n\n\n\n\n 40\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 45 of 90 PageID #:\n 285\n\n\n\n 171. Defendant Behrenbruch and his co-founder Andreas Kluge\u2019s stock sales were timed\n\n nearly to perfection, as is indicated in the chart of the common shares below.\n\n\n\n\n 172. Defendant Behrenbruch\u2019s sale of two million shares on February 27, 2025 violated\n\n Telix\u2019s Securities Dealing Policy, adopted by the Board of Directors effective December 12, 2024,\n\n and filed with the SEC as an exhibit to the Company\u2019s Form 20-F on February 24, 2025.\n\n 173. As set forth in Section V, Telix\u2019s February 26, 2025 press release falsely assured\n\n investors that Defendant Behrenbruch did not possess material inside information regarding\n\n Telix\u2019s FDA drug approvals at the time of his sales.\n\n F. Defendant Behrenbruch\u2019s Stock Sales Triggered a Duty to Disclose\n\n 174. Defendant Behrenbruch sold Telix shares while in possession of material, non-\n\n public information concerning TLX591, TLX250 (Zircaix), and TLX101 (Pixclara), as detailed\n\n herein.\n\n 175. Section 10(b) of the Securities Exchange Act of 1934 and the Securities and\n\n Exchange Commission's Rule 10b\u20135 prohibit undisclosed trading on inside corporate information\n\n by individuals who are under a duty of trust and confidence that prohibits them from secretly using\n\n such information for their personal advantage. Salman v. United States, 137 S. Ct. 420, 423 (2016).\n\n 176. Under the traditional or classical theory of insider trading liability, \u00a7 10(b) and\n\n Rule 10b-5 are violated when a corporate insider trades in the securities of his corporation on the\n\n 41\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 46 of 90 PageID #:\n 286\n\n\n\n basis of material, nonpublic information. Trading on such information qualifies as a deceptive\n\n device under \u00a7 10(b), because a relationship of trust and confidence exists between the\n\n shareholders of a corporation and those insiders who have obtained confidential information by\n\n reason of their position with that corporation. Chiarella v. United States, 445 U. S. 222, 228 (1980).\n\n That relationship gives rise to a duty to disclose or to abstain from trading. Id. at 228-229. As\n\n detailed herein, on the date of his stock sales, Defendant Behrenbruch knew, but did not disclose\n\n despite having a duty to do so, that (i) Telix\u2019s TLX101 (Pixclara) drug application to the FDA \u201cdid\n\n not provide substantial evidence of effectiveness\u201d (see \u00a7\u00a7 IV.B.); (ii) Telix had not obtained FDA\n\n approval for a full phase 3 trial of TLX591 (see \u00a7\u00a7 IV.C.); and (iii) that Telix\u2019s BLA for TLX250\n\n (Zircaix) had multiple material deficiencies that would preclude FDA approval (see \u00a7\u00a7 IV.D.).\n\n V. DEFENDANTS\u2019 MISREPRESENTATIONS\n\n 177. On October 17, 2024, Telix filed a Form 20-F with the SEC signed by Defendant\n\n Behrenbruch. The Form 20-F contained numerous false and misleading statements about TLX591\n\n (Prostate Drug), including:\n\n Our most advanced therapeutic candidate, TLX591 (177Lu-rosopatamab tetraxetan), is a\n lutetium-labelled radio antibody-drug conjugate, or rADC, which we are evaluating in a\n Phase 3 clinical trial in patients with advanced prostate cancer. We dosed the first patient\n in this clinical trial in November 2023 in Australia. We received authorization to conduct\n the trial in the United States in April 2024 and have opened clinical trial sites in the United\n States.\n\n 178. Defendants\u2019 statement about TLX591 were false and misleading as the FDA had\n\n not approved a full Phase 3 trial of TLX591, but only approved Part 1 of the ProstACT Global\n\n Phase 3 trial. See \u00a7IV.C.\n\n 179. Also on October 17, 2024, Telix issued a press release reporting on key\n\n achievements from the prior quarter. Defendant Behrenbruch was quoted as saying:\n\n\n 42\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 47 of 90 PageID #:\n 287\n\n\n\n Our achievements over the past quarter reinforce Telix\u2019s leadership in the\n radiopharmaceutical sector. We continue to make excellent progress across multiple late-\n stage assets in our therapeutic pipeline, while preparing to commercialise three new\n imaging agents within our precision medicine portfolio.\n\n 180. The press release assured investors that Telix was on track to resubmit its BLA for\n\n TLX250-CDx in November 2024, without disclosing the material deficiencies in that BLA then\n\n known to Defendants:\n\n Kidney cancer imaging, TLX250-CDx (Zircaix\u00ae15, 89Zr-girentuximab): Telix is on track\n to resubmit the Biologics License Application (BLA) for its kidney cancer imaging agent\n in November 2024, consistent with prior guidance, and continues to target a full U.S.\n commercial launch in 2025.\n\n 181. The press release also told investors that Telix had been cleared to begin a Phase 3\n\n trial of TLX591, without revealing that the FDA had only authorized the first part of that trial. The\n\n press release stated: \u201cFollowing allowance of an Investigational New Drug (IND) application by\n\n the U.S. Food and Drug Administration (FDA) in April 2024, the ProstACT GLOBAL Phase III\n\n trial is now enrolling patients at its first U.S. sites, in addition to ongoing patient dosing at sites in\n\n the Asia Pacific region.\u201d\n\n 182. Defendants\u2019 statements in the October 17, 2024 press release were false and\n\n misleading because: (i) Telix\u2019s BLA for TLX250-CDx (Zircaix) was plagued with serious\n\n deficiencies then known to Defendants, including the existence of particulates in the solution that\n\n did not exist in the version of the drug used in the clinical trials, such that asserting Telix would\n\n be able to commercialize TLX250-CDx in 2025, or that Telix was on track to file its BLA in\n\n November 2024, gave investors a false impression of the true state of development of TLX250,\n\n (see \u00a7IV.D.); and, (ii) Telix had not been \u201callowed\u201d by the FDA to conduct a full Phase 3 trial of\n\n TLX591 in the ProstACT Global trial (see \u00a7IV.C.).\n\n\n\n 43\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 48 of 90 PageID #:\n 288\n\n\n\n 183. On December 30, 2024, Telix filed a press release announcing it had submitted its\n\n BLA for TLX250-CDx (Zircaix) (Kidney Agent) to the FDA. The press release quoted Kevin\n\n Richardson, Chief Executive Officer of Telix\u2019s Precision Medicine Unit as stating:\n\n We are pleased to be progressing the BLA for TLX250-CDx, which has been granted\n Breakthrough designation, and may therefore be eligible for priority review. Telix\n continues to target a full U.S. commercial launch in 2025 addressing a major unmet\n medical need for patients with suspected ccRCC.\n\n 184. The Defendants\u2019 statements about Telix\u2019s Kidney Agent in the December 30, 2024\n\n press release were false and misleading because Defendants omitted to disclose that (i) Telix knew\n\n prior to submission of material deficiencies in the BLA, see \u00a7\u00a7 IV.D.2.-4; (ii) Telix had altered the\n\n manufacturing process from the clinical trial to the commercial version of TLX250 (Zircaix),\n\n which Defendants knew would raise comparability concerns with the FDA, see \u00a7 IV.D.6.; (iii)\n\n Telix relied on third-party manufacturers GBI and 3DI to make TLX250 (Zircaix), which had\n\n deficiencies known to Defendants that jeopardized FDA approval, see \u00a7\u00a7 IV.D.7. and IV.D.8; and\n\n (iv) the commercial version of TLX250 (Zircaix) contained visible particulates, further raising\n\n concerns about the manufacturing process and comparability, see \u00a7\u00a7 IV.D.3. and IV.D.6.\n\n Furthermore, the material deficiencies in the BLA for TLX250-CDx meant that Defendants could\n\n not reasonably believe Telix would make a commercial launch of TLX250-CDx in 2025, and it\n\n was materially misleading to assert such a launch date in light of the omitted material deficiencies\n\n in the BLA.\n\n 185. On February 20, 2025, after market close, Telix issued a press release, which\n\n misleadingly represented the status of the Company\u2019s drug pipeline without disclosing material\n\n facts known to Defendants. The press release stated:\n\n Telix continued to deliver on its growth strategy. The Company\u2019s key\n achievements, aligned to its strategic pillars:\n\n 44\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 49 of 90 PageID #:\n 289\n\n\n\n\n \u2022 Grow precision medicine: Prepared for launch of three new products\n TLX007-CDx (Gozellix\u00ae), TLX101-CDx (Pixclara\u00ae) and TLX250-CDx\n (Zircaix\u00ae)4 in 2025 while continuing to increase sales and market share for\n Illuccix\u00ae.\n\n \u2022 Deliver late-stage therapeutics: Expanded ProstACT GLOBAL Phase 3\n prostate cancer therapy trial recruitment in the U.S. and continued to\n advance therapeutic trials for the brain and kidney cancer programs.\n 4\n Launch and brand names subject to regulatory approval.\n\n 186. The press release quoted Defendant Behrenbruch:\n\n \u201c2024 has been an extraordinary year for Telix. We generated strong financial\n growth while investing for the future. The Precision Medicine business is poised\n for step-change growth with three commercial product launches planned for this\n year in the U.S. and the European rollout of Illuccix. We have a deep therapeutic\n pipeline with multiple assets moving into pivotal trials, and we are building out\n the infrastructure to ensure we can deliver our products to patients around the\n world. We see 2025 as a year of significant growth and evolution for Telix in terms\n of international business, multiple product launches and the integration of key\n infrastructure that will further deliver on our mission to ensure global patient\n access.\u201d\n\n 187. The February 20, 2025 press release was false and misleading because, as\n\n Defendants knew before February 20, 2025, (i) Telix\u2019s precision medicine unit faced material,\n\n undisclosed risks to being able to launch TLX250 (Zircaix) and TLX101 (Pixclara) in 2025, see\n\n \u00a7\u00a7 IV.B. and D.; (ii) Telix had not received FDA approval for the complete Phase 3 trial of\n\n TLX591, but only Part 1 of the Phase 3 trial, see \u00a7 IV.C.; and (iii) Telix had not built out the\n\n infrastructure to ensure it could deliver TLX250 (Zircaix) safely to patients, but rather had relied\n\n on third-party manufacturers GBI and 3DI, that had known deficiencies that placed FDA approval\n\n of TLX250 (Zircaix) at grave risk, see \u00a7\u00a7 IV.D.7. and IV.D.8.\n\n 188. On February 20, 2025, after market close, Telix held its earnings call for the 2024\n\n fiscal year. Defendant Behrenbruch participated in the conference call. During the February 20,\n\n\n 45\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 50 of 90 PageID #:\n 290\n\n\n\n 2025 conference call, an analyst asked about whether Telix anticipated any delays in its PDUFA\n\n dates for drugs being evaluated by the FDA. Defendant Behrenbruch and Telix\u2019s CEO of Precision\n\n Medicine Kevin Richardson responded that they anticipated no delays. Defendant Behrenbruch\n\n stated: \u201cWe\u2019ve already got clinical site inspections happening for Zircaix as well.\u201d Richardson\n\n continued: \u201cI would just add that, we continue to have good communications [with the FDA] as\n\n of today. And as Chris [Behrenbruch] mentioned, our visits [to the manufacturers of TLX250\n\n (Zircaix)] are scheduled and we\u2019re moving forward in the process. So that really hasn\u2019t changed.\u201d\n\n 189. Defendants\u2019 statements about \u201cgood communications\u201d with the FDA and the\n\n scheduled inspections of the TLX250 (Zircaix) manufacturing facilities were false and misleading\n\n when made because, as Defendants knew before February 20, 2025, (i) Telix had altered the\n\n manufacturing process from the clinical trial to the commercial version of TLX250 (Zircaix),\n\n which Defendants knew raised comparability concerns and the FDA raised these concerns with\n\n Telix in February 2025, see \u00a7\u00a7 IV.D.3. and IV.D.6.; (ii) Telix relied on third-party manufacturers\n\n GBI and 3DI to make TLX250 (Zircaix), which had known deficiencies that jeopardized FDA\n\n approval, see \u00a7\u00a7 IV.D.3., IV.D.7. and IV.D.8.; and (iii) the commercial version of TLX250\n\n (Zircaix) contained visible particulates, further raising concerns about safety, the manufacturing\n\n process, and comparability, see \u00a7\u00a7 IV.D.3. and IV.D.6.\n\n 190. During the February 20, 2025, conference call, Telix\u2019s CEO of Precision Medicine\n\n Kevin Richardson spoke in glowing terms of Telix\u2019s new imaging commercial portfolio of\n\n products:\n\n [G]lobal expansion of Telix\u2019s industry leading precision medicine portfolio is a key\n driver of our growth strategy. In the U.S. our commercial portfolio will continue\n to expand with the launches of our urology products Gozellix and Zircaix,\n followed by Pixclara for our neuro franchise.\n\n\n 46\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 51 of 90 PageID #:\n 291\n\n\n\n ***\n\n Zircaix is our first-in-class renal imaging agent designed to diagnose patients with\n ccRCC with undiagnosed renal masses. This is a new diagnostic area for PET\n imaging and Telix will leverage our success with the urologic physician and\n imaging centers who have growing confidence in PSMA imaging.\n\n Finally, our Pixclara agent will bring to neurology customers a technology that\n will quickly identify treatment related inflammation from tumor progression or\n pseudo progression and determine the best treatment pathway for the patient.\n\n ***\n\n Turning towards 2025, we\u2019ve already talked about the potential to launch three new\n products this year, which are subject to regulatory approval. Our launch planning\n is well underway. We built out the commercial infrastructure, we trained our\n customer facing teams and we\u2019re currently delivering disease awareness education\n to the customer base through multiple channels.\n\n ***\n\n In the U.S., Zircaix has filed a BLA in December of 2024 and we are expecting a\n PDUFA date after the U.S. summer in 2025.With an expanded access program\n already in place across the U.S. and globally, physicians are already using our\n innovative kidney agent around the world on their patients and it is included in the\n EAU guidelines as an emerging technology.\n\n Moving to our neurology platform, Pixclara has an NDA with a PDUFA date of\n April 26, 2025, also with an ongoing expanded access program in the U.S. Our\n neurology franchise will target global regulatory filings based on market\n opportunities as we go \u2013as we gain momentum around the globe.\n\n All the hard work our teams put in, in 2024 has set 2025 to be an exciting year as\n we transition to a multi-product multi-national commercial company,\n diversifying our revenue streams through multiple products across geographies.\n\n 191. Telix\u2019s statements in the above paragraph from the February 20, 2025 conference\n\n call were false and misleading because, as Defendants knew before February 20, 2025, (i) both\n\n TLX250 (Zircaix) and TLX101 (Pixclara) faced material, undisclosed risks to FDA approval that\n\n meant they would not contribute to Telix\u2019s precision medicine portfolio being \u201ca key driver of\n\n [Telix\u2019s] growth strategy\u201d in 2025, see \u00a7\u00a7 IV.B. and IV.D.; (ii) Telix had not \u201cbuilt out the\n\n 47\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 52 of 90 PageID #:\n 292\n\n\n\n commercial infrastructure\u201d necessary to launch TLX250 (Zircaix), but rather had relied on third-\n\n party manufacturers GBI and 3DI which had known material deficiencies placing FDA approval\n\n of TLX250 (Zircaix) at grave risk, see \u00a7\u00a7 IV.D.7 and IV.D.8.; and (iii) Telix had not put in \u201cthe\n\n hard work\u201d in 2024 necessary to make 2025 \u201can exciting year\u201d to transition Telix into a \u201cmulti-\n\n product multi-national commercial company\u201d through the approval of Zircaix and Pixclara, see \u00a7\u00a7\n\n IV.B. and IV.D.\n\n 192. During the February 20, 2025, conference call, Telix\u2019s CEO of Therapeutics\n\n Richard Valeix stated:\n\n Moving to TLX591, our lead therapeutic candidate. It is a highly differentiated\n asset. It\u2019s an antibody versus the classical peptide PSMA available. It\u2019s a big\n opportunity.\n\n ***\n\n As mentioned, this asset is now being studied in the ProstACT GLOBAL Phase 3\n trial. ProstACT GLOBAL is the first trial to combine the synergistic effects of\n PSMA radioactive antibody drug conjugate with androgen receptor pathway\n inhibition and the well-known docetaxel. It is generating a lot of KOL interest. This\n study is rebooting well, including ramping up in the U.S. we are on track to deliver\n interim readout in H1. As a reminder, the interim readout will be focusing on the\n Part 1 of the study with the first 30 patients, which is looking at safety and\n dosimetry of TLX591 in combination with the standard of care administered in the\n study.\n\n 193. Telix\u2019s statement about TLX591 was false and misleading, as the FDA had not\n\n approved a full Phase 3 trial of TLX591, but only approved Part 1 of the ProstACT Global trial.\n\n See \u00a7 IV.C.\n\n 194. During the February 20, 2025, conference call, Defendant Behrenbruch\n\n misrepresented Telix\u2019s manufacturing capacity, specifically as it applied to TLX250 (Zircaix).\n\n Telix relied on GBI and 3DI to manufacture TLX250 (Zircaix), which Defendants knew to suffer\n\n\n\n 48\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 53 of 90 PageID #:\n 293\n\n\n\n from material deficiencies. Defendant Behrenbruch made the following statement on the\n\n conference call:\n\n To deliver these products globally, you need to have infrastructure to really be able\n to go that last mile and make the product available with a high degree of confidence\n for patients.\n\n We\u2019ve been focusing on building that infrastructure, scaling it to meet the demand\n both today and the expected demand for our products. And this is really a two-part\n model for success. We are heavily dependent on key partnerships. Our goal is not\n to go at the task of manufacturing alone. And in almost every market we operate\n in, we have key supply chain, manufacturing, distribution and even sales and\n marketing partnerships. But we also have a certain amount of facilitative\n infrastructure ourselves.\n\n 195. Defendant Behrenbruch\u2019s statements about the Company having the ability to\n\n deliver product \u201cwith a high degree of confidence for patients\u201d because it had \u201ckey supply chain,\n\n manufacturing [and] distribution\u201d partnerships were false and misleading when made because, as\n\n Defendant Behrenbruch knew prior to February 20, 2025, Telix relied on 3DI and GBI to\n\n manufacture TLX250 (Zircaix), both of which suffered from deficiencies that would cause them\n\n to fail FDA inspections. Telix only had a couple of commercial products and TLX250 (Zircaix)\n\n was one of Telix\u2019s leading new drug applications, so Defendant Behrenbruch\u2019s statements would\n\n be understood by investors to pertain to TLX250 (Zircaix). See \u00a7\u00a7 IV.D.3., IV.D.7. and IV.D.8.\n\n 196. On February 20, 2025, Telix also published the Company\u2019s Annual Report for 2024\n\n (the \u201c2024 Annual Report\u201d), which it posted to the Company\u2019s website and then filed with the\n\n SEC on February 21, 2024. The 2024 Annual Report began with \u201cA message from the Chair\u201d that\n\n stated:\n\n Our precision medicine business is expanding Illuccix\u00ae into global markets\n including Europe and the United Kingdom, and, subject to regulatory approval, has\n planned commercial launches of our new prostate cancer imaging agent\n TLX007-CDx (Gozellix\u00ae3), our kidney cancer imaging agent TLX250-CDx\n\n\n 49\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 54 of 90 PageID #:\n 294\n\n\n\n (Zircaix\u00ae3), and TLX101-CDx (Pixclara\u00ae3) our imaging agent for cancerous\n brain lesions.\n\n We are progressing our therapeutic pipeline, through the Phase 3 ProstACT\n GLOBAL4 trial of TLX591, a therapeutic agent for prostate cancer. This trial has\n been expanded in 2024 to include U.S. sites. An interim read-out of Part 1 is\n expected in H1 2025.\n\n 3. Brand name subject to final regulatory approval.\n 4. ClinicalTrials.gov ID: NCT06520345.\n\n 197. The above statements in the 2024 Annual Report were false and misleading as (i)\n\n commercial launches were not going to happen because both TLX250 (Zircaix) and TLX101\n\n (Pixclara) suffered from known, undisclosed material defects that would foreclose FDA approval,\n\n see \u00a7\u00a7 IV.B. and IV.D.; and (ii) the FDA had not approved a full Phase 3 trial of TLX591, but only\n\n approved Part 1 of the ProstACT Global trial, see \u00a7 IV.C.\n\n 198. The 2024 Annual Report included a letter from Defendant Behrenbruch in which\n\n he claimed that Telix\u2019s three new drug applications \u2013 including TLX250 (Zircaix) and TLX101\n\n (Pixclara) \u2013 demonstrated that the Company\u2019s new strategy was a success:\n\n Our Strategy\n\n We have a clear strategy in place to leverage the near-term clinical and commercial\n opportunities within our Px (imaging) business, while continuing to develop the\n therapies that will define our future clinical and shareholder value creation. Our Px\n and Tx businesses share a common investment in the infrastructure we are building,\n both through direct investments in supply chain and manufacturing capabilities, as\n well as strategic partnerships in key markets.\n\n 2024 has therefore been a transformative year, in which we have laid the strategic\n foundation for the next phase of growth. Our strategy is simple: deliver, grow,\n build and expand.\n\n ***\n\n This strategy is evident in our execution. We filed three new drug applications\n for Px products that have the potential to significantly impact the standard of\n care while super-charging Telix\u2019s cash generation capability. We advanced our\n\n 50\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 55 of 90 PageID #:\n 295\n\n\n\n highly-differentiated Tx radiopharmaceutical pipeline, which, we believe, is the\n deepest in the industry. This included the acquisition of new targets and modalities\n with the potential to considerably broaden our future clinical impact. Our clinical\n and regulatory activities are driving geographic expansion across multiple markets\n with the goal of being commercially active in over 30 countries by the end of 2025.\n Finally, our investments in supply chain, manufacturing and distribution\n capabilities are designed to ensure Telix and select partners achieve best-in-class\n delivery performance and reliability to patients \u2013 wherever we operate.\n\n Investing for growth\n\n By the end of 2025, we expect Telix to look like a different company yet again. Our\n metamorphosis is well underway, as we become a globally active, multi-product\n company, with the infrastructure in place to scale for future demand.\n\n ***\n\n Conclusion\n\n Having built a strong foundation over the last few years, and with several major\n inflection points achieved in 2024, we are on the cusp of exponential growth.\n\n 199. The above statements in the 2024 Annual Report were false and misleading as (i)\n\n Telix had not \u201claid the strategic foundation for the next phase of growth\u201d and Telix\u2019s \u201cthree new\n\n drug applications\u201d were not evidence of the Company\u2019s execution, as two of these new drug\n\n applications \u2013 TLX250 (Zircaix) and TLX101 (Pixclara) \u2013 contained serious material deficiencies,\n\n see \u00a7\u00a7 IV.B. and IV.D.; and (ii) Telix had not made \u201cinvestments in supply chain, manufacturing\n\n and distribution capabilities\u201d sufficient to \u201censure Telix and select partners achieve best-in-class\n\n delivery performance and reliability to patients\u201d as Telix had in fact relied upon 3DI and GBI to\n\n manufacture TLX250 (Zircaix), and both suffered from material undisclosed deficiencies, see \u00a7\u00a7\n\n IV.D.3., IV.D.7 and IV.D.8.\n\n 200. The 2024 Annual Report further falsely assured investors that Telix believed it\n\n would launch TLX250 in 2025, without disclosing the known deficiencies in the BLA Telix\n\n submitted to the FDA. It stated:\n\n 51\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 56 of 90 PageID #:\n 296\n\n\n\n TLX250-CDx (Zircaix2, 89Zr- girentuximab) is a PET diagnostic imaging agent for\n the characterization of renal masses as ccRCC. Telix completed its U.S. BLA for\n TLX250-CDx PET imaging of ccRCC in December 2024. We continue to target a\n U.S. commercial launch in H2 2025, pending acceptance of the BLA for filing, and\n regulatory approval.\n\n 2. Brand name subject to final regulatory approval.\n\n 201. The 2024 Annual Report also included disclosures on known risks, and false and\n\n misleading \u201cKey mitigation strategies and tactics\u201d to deal with these known risks. For instance,\n\n the 2024 Annual Report indicated \u201cSupply chain resilience and responsibility\u201d as a known risk\n\n and falsely stated the Company had taken significant precautions to address this risk, when in fact\n\n Telix knew its TLX250 (Zircaix) third-party suppliers were materially deficient and would not\n\n pass an FDA inspection:\n\n Telix has dual supply surety where possible and continues to seek viable and\n sustainable opportunities for end-to-end supply chain integration within the Group\n structure - for example, through the acquisition and development of in-house\n manufacturing capability at its TMS facilities, reducing exposure to third-party risk.\n Supplier risk programs are critical elements of Telix\u2019s risk mitigation tactics in\n this area and we aim to continuously improve our vendor selection, diligence and\n vendor management strategy and framework to manage supply chain resilience\n and related risk.\n\n 202. The 2024 Annual Report similarly reassured investors that Telix validated the\n\n manufacturing processes used to produce its products to ensure product quality, even though Telix\n\n knew its third-party manufacturers of TLX250 (Zircaix) were deficient. The 2024 Annual Report\n\n stated:\n\n Telix is committed to delivering high quality innovative medicines to patients and\n conducting our clinical trials with a philosophy and in a manner that recognizes the\n importance of patient safety and respecting the rights of participants.\n\n ***\n\n Telix has a Quality Management System (QMS) in place based on the international\n ISO 9001 series of Quality Management standards that is consistently\n\n 52\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 57 of 90 PageID #:\n 297\n\n\n\n implemented, and risk-based to maintain quality product for clinical and\n commercial distribution.\n\n ***\n\n Telix products are researched, manufactured and tested at certified Good\n Laboratory Practice (GLP), Good Distribution Practice (GDP) and Good\n Manufacturing Practice (GMP) facilities, and processes, methods and change\n control are validated.\n\n 203. Defendants\u2019 above statements from the 2024 Annual Report were false and\n\n misleading when made because Telix had in fact relied upon 3DI and GBI to manufacture TLX250\n\n (Zircaix), and both suffered from material undisclosed deficiencies known to Defendants. See \u00a7\u00a7\n\n IV.D.3., IV.D.7., and IV.D.8.\n\n 204. The 2024 Annual Report also falsely assured investors that Defendants anticipated\n\n that TLX101-CDx would be approved and be sold commercially in 2025. It stated:\n\n The FDA accepted the NDA and granted priority review for Pixclara on 24 October\n 2024. With priority review status and PDUFA goal date of 26 April 2025, a\n commercial launch is anticipated in 2025.\n\n 205. Defendants\u2019 above statement from the 2024 Annual Report was false and\n\n misleading when made because Telix had already been notified by the FDA of significant\n\n deficiencies in its TLX101 NDA and therefore knew there was not a reasonable basis to believe it\n\n would launch in 2025. See \u00a7 IV.B.\n\n 206. On February 24, 2025, the Company filed with the SEC its Annual Report on Form\n\n 20-F for the year ended December 31, 2024 (the \u201c2024 Form 20-F\u201d). Attached to the 2024 Form\n\n 20-F were certifications pursuant to the Sarbanes-Oxley Act of 2002 (\u201cSOX\u201d) signed by Defendant\n\n Behrenbruch attesting to the accuracy of financial reporting, the disclosure of any material changes\n\n to the Company\u2019s internal control over financial reporting, and the disclosure of all fraud.\n\n\n\n 53\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 58 of 90 PageID #:\n 298\n\n\n\n 207. The 2024 Form 20-F falsely stated the Company had authority to go forward with\n\n a Phase 3 trial of TLX591:\n\n We have not submitted any applications for regulatory approval or obtained\n regulatory approval for any of our therapeutic product candidates. Our most\n advanced therapeutic candidate, TLX591 (177Lu-rosopatamab tetraxetan), is a\n lutetium-labeled radio antibody-drug conjugate, or rADC, which we are evaluating\n in a Phase 3 clinical trial in patients with advanced prostate cancer. We dosed\n the first patient in this clinical trial in November 2023 in Australia. We received\n authorization to conduct the trial in the United States in April 2024 and are\n actively dosing patients at multiple clinical trial sites. We cannot be certain that\n TLX591, or any of our clinical trials of our other therapeutic product candidates,\n will generate safety and efficacy data sufficient for regulatory approval in any\n jurisdiction.\n\n 208. Similarly, the 2024 Form 20-F stated:\n\n In 2024, we expanded the dosing of patients in the Phase 3 ProstACT GLOBAL\n study from the Asia Pacific region to the U.S. This is a study of TLX591 (177Lu-\n rosopatamab tetraxetan), our lead radio antibody-drug conjugate therapy candidate\n for advanced prostate cancer. This [is a] multinational Phase 3 study to investigate\n and confirm the benefits and risks associated with TLX591, when administered\n together with standard of care, or SoC, and compared to SoC alone.\n\n 209. The 2024 Form 20-F also stated that Telix would proceed to the second portion of\n\n the Phase 3 ProstACT Global trial of TLX591 after finishing the first part, without any reference\n\n to the required FDA approval to do so.\n\n We are also investigating TLX591 in the Phase 3 ProstACT GLOBAL clinical trial.\n We expect this trial to enroll 30 patients in a dosimetry and safety lead-in portion\n in replicating the prior study using the product candidate specifications intended\n for commercial release and then proceed to a randomized treatment expansion\n portion, in up to approximately 490 patients. The trial is a multi-national, multi-\n center, prospective, randomized, controlled, open label study designed to\n investigate and confirm the benefits and risks associated with TLX591 a high-\n affinity PSMA-targeted rADC that delivers DNA breaking radiation directly to\n PSMA-positive bone, nodal, or visceral metastases in patients with mCRPC. The\n trial will enroll patients that have PSMA-positive mCRPC who have experienced\n disease progression following treatment with an androgen receptor pathway\n inhibitor (abiraterone or enzalutamide) that was received in either the metastatic\n castration-sensitive prostate cancer or first-line mCRPC treatment setting. The\n primary endpoint of the randomized portion of the trial is radiographic progression-\n\n 54\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 59 of 90 PageID #:\n 299\n\n\n\n free survival and secondary endpoints include overall survival, objective response\n rate, time to first symptomatic skeletal events, PFS, PSA decline of more than 50%,\n quality of life and safety and tolerability.\n\n 210. Similarly, the 2024 Form 20-F stated:\n\n In November 2023, we initiated a randomized, multinational, multicenter, open-label Phase\n 3 trial, which we refer to as the ProstACT GLOBAL trial, to evaluate TLX591 for the\n treatment of PSMA-positive mCRPC patients in combination with the standard of care\n compared to the standard of care alone. We expect this trial to enroll 30 patients in a\n dosimetry and safety lead-in portion replicating the prior study using the product candidate\n specifications intended for commercial release and then proceed to a randomized\n treatment expansion portion, in up to approximately 490 patients.\n\n 211. The 2024 Form 20-F also falsely stated that Telix had been given approval to\n\n conduct efficacy testing in the PROSTACT clinical trials, when the Company had only been\n\n granted FDA approval for Part 1 of the study testing safety. The 2024 Form 20-F stated: \u201cWe are\n\n evaluating the safety and efficacy of TLX591 in the ProstACT series of clinical trials.\u201d\n\n 212. Defendants\u2019 statements in the 2024 Form 20-F concerning TLX591 were false and\n\n misleading because the FDA had not authorized Telix to conduct a full Phase 3 trial, but only\n\n approved Part 1 of the trial. Telix could not automatically \u201cproceed to a randomized treatment\n\n expansion portion\u201d of the trial. As set forth in Section IV.C.5., Telix\u2019s 2025 Form 20-F corrected\n\n the misleading statements in the 2024 Form 20-F after the SEC opened a formal investigation of\n\n Telix and subpoenaed the Company.\n\n 213. The 2024 Form 20-F included the following false and misleading risk disclosure.\n\n Additionally, as we expect the market for Illuccix and PSMA-PET imaging to\n expand and our product candidates progress through preclinical studies and clinical\n trials towards potential approval and commercialization, it is possible that various\n aspects of manufacturing will be altered in an effort to optimize processes and\n results. Such changes may require new submissions to and approval from\n regulators, which may further delay the timeframes under which modified\n manufacturing processes can be used for Illuccix or any of our product\n candidates, and additional bridging studies or trials may be required. Any such\n\n\n 55\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 60 of 90 PageID #:\n 300\n\n\n\n delay could harm our business, financial condition, results of operations and\n prospects.\n\n 214. This statement of a purported, future hypothetical risk was false and misleading at\n\n the time it was made because Telix had in fact, as Defendants knew, already altered the\n\n manufacturing process for the commercial version of TLX250-CDx versus the version used in the\n\n clinical study. As detailed in Sections IV.D.3. and IV.D.6. supra, according to FE-1 the changed\n\n manufacturing process caused the FDA to more closely scrutinize the comparability of the clinical\n\n and commercial version of TLX250, which Telix knew would be of significant concern to the FDA\n\n particularly in light of the particulate matter in the solution and which ultimately led to the FDA\n\n rejecting TLX250. Telix did not disclose this actual risk that had occurred, rather than the\n\n hypothetical risk disclosure that it was \u201cpossible.\u201d\n\n 215. The 2024 Form 20-F included the following risk disclosures regarding the\n\n Company\u2019s reliance upon third-party manufacturers to comply with \u201cCurrent Good Manufacturing\n\n Practices\u201d or cGMPs:\n\n We, our contract manufacturers, any future collaborators and their contract\n manufacturers could be subject to periodic unannounced inspections by the FDA\n or other comparable foreign regulatory authorities, to monitor and ensure\n compliance with cGMPs or similar foreign requirements. Despite our efforts to\n audit and verify regulatory compliance, we or one or more of our third-party\n manufacturing vendors may be found on regulatory inspection by the FDA or\n other comparable foreign regulatory authorities to be noncompliant with cGMPs\n or similar foreign regulations. This may result in shutdown of our facility or that\n of the third-party vendor or invalidation of product lots or processes, which could\n adversely affect our business, financial condition, results of operations and\n prospects. In some cases, a product recall may be warranted or required, which\n would materially affect our ability to supply and market our products and could be\n costly and result in reputational damage.\n\n 216. This statement of a purported, future hypothetical risk was false and misleading at\n\n the time it was made because Telix had in fact, as Defendants knew, already conducted an audit\n\n\n 56\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 61 of 90 PageID #:\n 301\n\n\n\n and inspection of GBI, one of the third-party manufacturers of TLX250-CDx and discovered that\n\n GBI had material deficiencies that needed to be fixed. Telix submitted the TLX250-CDx BLA\n\n anyway. As detailed in Section IV.D.7. supra, according to FE-1 GBI failed the audit in late-2024\n\n and had not addressed the problems identified, which Telix knew would be of significant concern\n\n to the FDA and which ultimately led to the FDA rejecting TLX250. Telix did not disclose GBI\n\n suffered from known deficiencies, but merely that the FDA could find noncompliance.\n\n 217. The 2024 Form 20-F included the following risk disclosures regarding the\n\n Company\u2019s reliance upon third-party manufacturers to comply with FDA requirements:\n\n Third-party manufacturers may not be able to comply with cGMPs or similar\n regulatory requirements outside of the United States. If our manufacturers cannot\n successfully manufacture material that conforms to our specifications and the\n strict regulatory requirements of the FDA and any applicable foreign regulatory\n authority, they will not be able to secure and/or maintain regulatory approval for\n their manufacturing facilities. If these facilities are not approved for commercial\n manufacture or are not able to maintain approval, we may need to find alternative\n manufacturing facilities, which could significantly impact our ability to develop,\n obtain regulatory approval for or market our products or product candidates as\n alternative qualified manufacturing facilities may not be available on a timely or\n cost-efficient basis, or at all.\n\n 218. This statement of a purported, future hypothetical risk was false and misleading at\n\n the time it was made because Defendants already knew both 3DI and GBI did not conform to the\n\n strict regulatory requirements of the FDA, as detailed in Sections IV.D.3., IV.D.7., and IV.D.8.\n\n supra.\n\n 219. The 2024 Form 20-F misleadingly assured investors that Telix resubmitted its BLA\n\n for TLX250 after addressing the concerns raised by the FDA in the first application:\n\n We submitted a BLA for TLX250-CDx to the FDA for regulatory approval in\n December 2023 for characterization of masses as ccRCC. The BLA was granted on\n a rolling review process. We completed the BLA submission in May 2024, and in\n July 2024, the FDA declined to review the BLA and issued an RTF determination.\n The denial of acceptance for filing was based on a filing concern related to\n\n 57\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 62 of 90 PageID #:\n 302\n\n\n\n demonstrating adequate sterility assurance during dispensing of TLX250-CDx in\n the radiopharmacy production environment. We resubmitted the BLA to the FDA\n in December 2024. While we believe that TLX250-CDx has met all sterility\n requirements of product release and that we have completed the required\n remedial actions, there can be no assurance that FDA will accept the BLA for\n review or that we will obtain regulatory approval from the FDA. If approved,\n TLX250-CDx would be the first targeted radiopharmaceutical imaging agent for\n kidney cancer to be approved in the United States.\n\n 220. Defendants\u2019 statements in the 2024 Form 20-F concerning TLX250-CDx were false\n\n and misleading because, among other things, Telix had failed to address remedial actions the FDA\n\n suggested when the FDA declined to review the first BLA submission for TLX250-CDx. See \u00a7\n\n IV.D.2. In this context, after Telix had already engaged in dialogue with the FDA on the first\n\n submission, the statement \u201cwe have completed the required remedial actions\u201d misled investors\n\n by suggesting Telix had addressed all of the FDA\u2019s concerns. Telix had not, and Defendants were\n\n aware of other material concerns that would cause the FDA to reject the application. See \u00a7 IV.D.3.\n\n 221. The Telix 2024 Form 20-F also misleadingly stated \u201cwe intend to broaden our\n\n commercial footprint in precision medicine by . . . obtaining approval for TLX101-CDx for the\n\n imaging of glioma. The application has been granted priority review and designated a PDUFA\n\n goal date of April 26, 2025, paving the way for a U.S. commercial launch in 2025.\u201d\n\n 222. Defendants\u2019 statement regarding the commercial launch of TLX101-CDx was\n\n misleading. As set forth in \u00a7 IV.B., Defendants knew the FDA had found significant deficiencies\n\n in the NDA for TLX101-CDx (Pixclara). There was no legitimate basis to assert the April 26, 2025\n\n PDUFA date \u201cpaved the way\u201d for a U.S. launch in 2025.\n\n 223. The Telix 2024 Form 20-F also misleadingly described the trial data for TLX101-\n\n CDx:\n\n\n\n\n 58\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 63 of 90 PageID #:\n 303\n\n\n\n Clinical Programs and Data \u2013 TLX101-CDx\n\n In August 2024, we submitted an NDA to the FDA for regulatory approval of\n TLX101-CDx as a radioactive diagnostic agent indicated for use with PET imaging\n for the characterization of progressive or recurrent glioma from treatment related\n changes in both adult and pediatric patients through the 505(b)(2) NDA regulatory\n pathway.\n\n The ability of TLX101-CDx trials to differentiate between various tumor subtypes\n and disease stages has been evaluated in 725 glioma patients across 14 comparative\n trials. Trial designs were both prospective and retrospective. Using various imaging\n technique specifications, studies compared TLX101-CDx with magnetic resonance\n imaging, [and other methods commonly used]. These trials provided evidence that\n TLX101-CDx tended to result in higher sensitivity and specificity.\n\n TLX101-CDx was also the subject of a published systemic review and meta-\n analysis covering 26 studies with a total of 1206 patient/lesions, that conclude that\n TLX101-CDx showed promise as a complementary modality to standard-of-care\n MRI for the management of brain malignancies.\n\n 224. Defendants\u2019 statements regarding the trial data supporting TLX101-CDx were\n\n misleading. As set forth in \u00a7 IV.B., Defendants knew the FDA had found the trial data in the NDA\n\n for TLX101-CDx (Pixclara) \u201cdid not provide substantial evidence of effectiveness\u201d and it was\n\n therefore misleading to tell investors otherwise.\n\n 225. The Telix 2024 Form 20-F also misleadingly stated: \u201cWith respect to producing\n\n radiolabeled drug product, we aim to continue to deepen our relationship with key manufacturing\n\n networks in the United States: Pharmalogic for [Zirconium] products [and] Cardinal Health for\n\n [Zirconium] products. . . .\u201d\n\n 226. This statement was false and misleading. Telix did not disclose that it relied upon\n\n 3DI for zirconium for TLX250-CDx (Zircaix) (Kidney Agent).\n\n 227. On February 25, 2025, Telix issued a press release titled \u201cRecruitment Spotlight:\n\n Phase 3 Clinical Trial of Novel Prostate Cancer Radiopharmaceutical Now Active in Miami.\u201d The\n\n press release stated:\n\n 59\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 64 of 90 PageID #:\n 304\n\n\n\n Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company)\n announces that the Biogenix Molecular Research Center in Miami, FL, is\n recruiting and dosing patients in the ProstACT Global Phase 3 trial1 of TLX591\n for patients with advanced prostate cancer, as part of a wider United States (U.S.)\n roll-out.\n\n ProstACT Global is trialling a promising new treatment option for prostate cancer,\n which is the most commonly diagnosed cancer and the second leading cause of\n cancer-related death for U.S. men. This month, Biogenix Molecular Research\n Center successfully administered two doses of TLX591, 14 days apart, to a local\n Miami-based patient, and continues to recruit eligible patients in the Miami area.\n 1\n ClinicalTrials.gov ID: NCT06520345.\n\n 228. The press release further stated:\n\n The ProstACT Global trial design consists of an international, multicenter trial in\n two parts: Part 1, safety and dosimetry run-in with 30 patients; and Part 2, 2:1\n randomized global expansion with an overall target enrolment of approximately\n 490 patients. Eligible patients must have confirmed progressive mCRPC assessed\n with a 68Ga-PSMA-11 PET6 imaging agent (such as Illuccix\u00ae) following prior\n treatment with an ARPI.\n 6\n Positron emission tomography.\n\n 229. The February 25, 2025 press release was false and misleading because the FDA\n\n had not approved a full Phase 3 trial of TLX591, but only approved Part 1 of the ProstACT Global\n\n trial. See \u00a7 IV.C. Furthermore, it was misleading for Telix to tout the dosing of patients in Miami\n\n when dosing had already been ongoing for months, but Telix issued the press release precisely to\n\n support the stock price knowing its CEO would sell a massive block of shares only two days later.\n\n See \u00a7 IV.E.\n\n 230. On February 26, 2025, Telix issued a press release announcing the FDA had\n\n accepted its BLA for TLX250. The press release was effusive in its praise for TLX250. It stated:\n\n Telix today announces that the United States (U.S.) Food and Drug Administration\n (FDA) has accepted the Biologics License Application (BLA) for its breakthrough\n investigational kidney cancer PET1 imaging agent TLX250-CDx (Zircaix\u00ae2, 89Zr-\n\n\n 60\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 65 of 90 PageID #:\n 305\n\n\n\n DFO-girentuximab), granted a Priority Review and provided a PDUFA3 date of 27\n August 2025, paving the way for a U.S. commercial launch in 2025.\n\n If approved, TLX250-CDx will become the first commercially available imaging\n agent to accurately and non-invasively diagnose and characterize clear cell renal\n cell carcinoma (ccRCC), the most common and one of the most aggressive sub-\n types of kidney cancer. It works by specifically binding to carbonic anhydrase IX\n (CAIX), a validated target protein expressed on 95% of ccRCC cells to produce\n images with high tumor-to-background ratio and high intra- and inter-reader\n consistency.\n\n The BLA is based on Telix\u2019s successful global Phase 3 ZIRCON4 study, which\n demonstrated a sensitivity of 86%, specificity of 87% and a positive predictive\n value (PPV) of 93% for ccRCC, including in very small, difficult-to-detect lesions5.\n The results of this study were published in The Lancet Oncology in September\n 2024, in a peer-reviewed manuscript by Professor Brian Shuch (University of\n California, Los Angeles, UCLA) and colleagues6. The paper outlines the critical\n unmet need for a new, non-invasive technique that can accurately detect and\n differentiate ccRCC from other renal masses in patients and concluded that\n TLX250-CDx meets this need and \u2018has the potential to be practice changing.\u2019\n\n Kevin Richardson, Chief Executive Officer, Precision Medicine, said, \u201cWe are\n delighted that the FDA has accepted this BLA as it moves us one step closer to\n bringing our breakthrough product to patients. We are aiming to revolutionize the\n management of kidney cancer, just as PSMA-PET/CT7 scanning has changed the\n management of prostate cancer. By providing a more definitive clinical diagnosis\n for renal masses, we believe that Zircaix2 will help physicians make more timely\n and confident patient management decisions and more quickly provide patients\n with a clear understanding of their disease and treatment options. Building further\n on Telix\u2019s successful urology franchise, we are preparing to bring this powerful\n precision medicine product to market in 20258.\u201d\n 1\n Positron emission tomography.\n 2\n Brand name subject to final regulatory approval.\n 3\n Prescription Drug User Fee Act.\n 4\n Zirconium in Renal Cancer Oncology, ClinicalTrials.gov ID: NCT03849118.\n 5\n Telix ASX disclosures 7 November 2022.\n 6\n Shuch et al. Lancet Oncology. 2024.\n 7\n Imaging of prostate-specific membrane antigen with positron emission\n tomography/computed tomography.\n 8\n Subject to regulatory approval.\n\n 231. The February 26, 2025 press release was false and misleading because, as detailed\n\n in Section IV.D., it failed to disclose that Defendants already knew the BLA for TLX250-CDx\n\n 61\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 66 of 90 PageID #:\n 306\n\n\n\n (Zircaix) suffered from numerous material deficiencies that were likely to be discovered by the\n\n FDA and lead to the BLA being denied, but Defendants had submitted the BLA anyway to prop\n\n up the Company\u2019s stock price so CEO Behrenbruch could sell shares at artificially inflated prices.\n\n 232. On February 26, 2025, Telix issued a press release notifying investors that\n\n Defendant Behrenbruch would be selling two million shares of Telix stock, and that the \u201cBoard of\n\n Directors has approved the sale[.]\u201d\n\n 233. The February 26, 2025 press release was false and misleading in that Defendant\n\n Behrenbruch was then in possession of material non-public information regarding Telix, and any\n\n sale of Telix shares by him would be a violation of American and Australian securities laws, as\n\n well as Telix\u2019s Securities Dealing Policy adopted by the Board of Directors effective December\n\n 12, 2024. Telix\u2019s Securities Dealing Policy states that \u201can Employee [ ] who possesses Inside\n\n Information in relation to Telix Securities . . . must not: apply for, acquire or dispose of those\n\n securities, or agree to do so . . . .\u201d The Telix Securities Dealing Policy states: \u201cInside Information\n\n may include matters of supposition, matters that are not yet certain and matters relating to a\n\n person\u2019s intentions\u201d and would include \u201cundisclosed material operational or regulatory\n\n developments\u201d and \u201clikely receipt or grant (or decline) of a market authorization approval by a\n\n regulatory agency[.]\u201d Defendant Behrenbruch was in possession of such information.\n\n 234. Furthermore, the February 26, 2025 press release was also false and misleading in\n\n that it asserted the Telix Board of Directors had approved Defendant Behrenbruch\u2019s sales, even\n\n though such sales clearly failed the \u201cFront Page Test.\u201d The Telix Securities Dealing Policy states:\n\n \u201cWhere any approval is required for a dealing under this Policy, approval will not be granted where\n\n the dealing would not satisfy the Front Page Test.\u201d The Front Page Test, as set forth in Telix\u2019s\n\n Securities Dealing Policy, states that Employees should ask themselves: \u201cIf the market was aware\n\n 62\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 67 of 90 PageID #:\n 307\n\n\n\n of all the current circumstances, could I be perceived to be taking advantage of my position in an\n\n inappropriate way? How would it look if the transaction were reported on the front page of the\n\n newspaper?\u201d Here, Behrenbruch sold two million shares while knowing material inside\n\n information concerning the drug applications for TLX591, TLX250-CDx, and TLX101-CDx, all\n\n of which negatively impacted the Company\u2019s stock price. Behrenbruch violated the Securities\n\n Dealing Policy, and approval by the Board of Directors was either obtained through subterfuge or\n\n willing disregard for the truth. The Company\u2019s press release painted the false impression that\n\n Behrenbruch had no material negative information about the Company\u2019s drug applications and\n\n thus enabled Behrenbruch to sell shares at an artificially inflated stock price.\n\n 235. On April 22, 2025, after market close, Telix issued a press release, which\n\n misleadingly represented the status of the Company\u2019s drug pipeline without disclosing the material\n\n facts known to Defendants. The press release stated:\n\n ProstACT\u2122 Global, the Phase 3 trial of TLX591 (177Lu-rosopatamab tetraxetan),\n Telix\u2019s prostate cancer therapy candidate, continues to recruit and remains on track\n to deliver a Part 1 readout (safety and dosimetry) in H1 2025.\n\n ***\n\n The FDA accepted the Biologics License Application (BLA) for Telix\u2019s kidney\n cancer imaging candidate TLX250-CDx (Zircaix\u00ae15, 89Zr-DFO-girentuximab),\n granted a Priority Review, and provided a PDUFA16 goal date of 27 August 2025.\n\n The NDA for TLX101-CDx (Pixclara\u00ae15, 18F-floretyrosine or 18F-FET), Telix\u2019s\n brain cancer imaging candidate, continues to progress with a PDUFA goal date of\n 26 April 2025.\n 15\n Brand name subject to final regulatory approval.\n 16\n Prescription Drug User Fee Act.\n\n 236. These statements were materially false and misleading at the time they were made\n\n for the reasons stated in Section IV. In particular, by April 22, 2025, Defendants already had been\n\n\n 63\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 68 of 90 PageID #:\n 308\n\n\n\n updated by the FDA as to the significant deficiencies in the application for TLX101-CDx\n\n (Pixclara). See \u00a7IV.B. Indeed, the FDA would deny the application only three days later on April\n\n 25, 2025; the rejection was not a surprise. Id.\n\n 237. After the market closed on August 20, 2025, Telix issued a press release reporting\n\n its first half of 2025 financials. The press release included the following statement from Defendant\n\n Behrenbruch:\n\n Telix continues to deliver strong revenue growth while building a foundation for\n the future. The first half of 2025 was a period of rapid transformation as we\n expanded our global manufacturing operations, invested in launching new products\n in new markets, and accelerated the development of our therapeutic pipeline. These\n investments have positioned Telix for sustainable, long-term growth, while our\n diversified business provides multiple drivers of success. To generate future\n revenue growth, we are confident in securing product approvals for Pixclara and\n Zircaix while advancing geographic and indication expansion for the PSMA\n portfolio.\n\n 238. After the market close on August 20, 2025, Telix conducted its earnings call for the\n\n first half of 2025 (the \u201c1H Call\u201d). Defendants misleadingly told investors that the Company\u2019s sales\n\n force was ready to sell Zircaix and that the Company was \u201cexcited about the launch\u201d of Zircaix\n\n because the \u201cmarket is ready for this product[,]\u201d when in fact Defendants knew in August 2025\n\n that the FDA would reject the Zircaix BLA.\n\n [Analyst] Xiaochuan Dai\n\n Congrats on the quarter. I\u2019m just curious about the Zircaix launch readiness. Maybe\n you can highlight some of the things you\u2019ve been doing for Zircaix and how should\n we think about the launch in the first and the second quarter after approval on\n August 27?\n\n [Defendant] Christian P. Behrenbruch\n\n There\u2019s probably not too much to really kind of openly discuss. I mean the\n commercial team, it\u2019s not their first rodeo. We\u2019re selling into the same customer\n base, same referral physician base as Illuccix. So it\u2019s a very straightforward\n pathway to the customer. We\u2019re clearly focused on using our Illuccix customer base\n\n 64\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 69 of 90 PageID #:\n 309\n\n\n\n to seed that product launch. And I would say commercial team is ready to rock\n and roll on Zircaix. I don\u2019t know if you want to add anything to that, Kev?\n\n [Telix CEO Precision Medicine] Kevin Richardson\n\n No, I think the combination of a urological call point with a nuclear med physician\n base that\u2019s reading that is really the key to success there. And we\u2019ve had an\n expanded access program going for a while that\u2019s demonstrated exactly what we\n saw in the ZIRCON study. So we\u2019re excited about the launch and just haven\u2019t\n given guidance for 2026 yet.\n\n [Defendant] Christian P. Behrenbruch\n\n Yes. I mean we\u2019ve had a lot -- the expanded access program, the EAP has been a\n huge success. We\u2019ve done a very, I think, well-orchestrated unbranded physician\n education campaign. So as far as we\u2019re concerned, the market is ready for this\n product.\n\n 239. As detailed in Section IV.D., Defendants\u2019 August 20, 2025 press release and\n\n statements concerning bringing TLX250 (Zircaix) to market were false and misleading.\n\n Defendants, including Behrenbruch, could not possibly be \u201cconfident in securing product\n\n approval[ ] for [ ] Zircaix\u201d or \u201cexcited about the launch,\u201d and any such statements were misleading\n\n in light of the material facts known to Defendants at that time, but undisclosed to investors. As\n\n detailed in Sections IV.D.6., IV.D.7., and IV.D.8., Telix met with the FDA for the Late-Cycle\n\n Review Meeting in June 2025, which FE-1 attended along with Defendant Behrenbruch. During\n\n this meeting, the FDA indicated it could not approve TLX250 until, among other things, GBI and\n\n 3DI passed follow-up inspections to show they had corrected the deficiencies cited in the Form\n\n 483 reports. According to FE-1: \u201cThe FDA was clear in the June meeting that successful\n\n inspections at the manufacturers were required for approval.\u201d It was also clear that there was not\n\n enough time for the re-inspection of 3DI to occur before the August 2025 PDUFA date. Further,\n\n the FDA wanted Telix to run a statistically significant human study to demonstrate comparability,\n\n which Telix could not do before the PDUFA date.\n\n 65\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 70 of 90 PageID #:\n 310\n\n\n\n 240. Also on the August 20, 2025 conference call, Telix\u2019s Chief Financial Officer\n\n Darren Smith made the following statement regarding the Company\u2019s manufacturing and supply\n\n chain, which was vital to Telix\u2019s ability to deliver highly sensitive radioactive medicines and\n\n diagnostic products:\n\n We continue to invest strategically into our manufacturing and supply chain\n infrastructure to preserve our competitive edge and to ensure we are in a position\n to scale efficiently as demand grows.\n\n 241. Adding to Smith\u2019s comments regarding the supply chain, Defendant Behrenbruch\n\n made the following statements on the 1H Call without revealing that the FDA had already found\n\n numerous deficiencies in Telix\u2019s manufacturing and supply chain that would indefinitely delay\n\n approval of TLX250 (Zircaix):\n\n Turning to manufacturing and supply chain excellence. I want to emphasize that\n radiopharmaceutical manufacturing and distribution is an extremely complex\n business from an operational quality and regulatory perspective. A robust, reliable\n supply chain is critical to long-term success, especially for a multiproduct\n portfolio like ours that\u2019s also going to one day deliver therapeutic outcomes.\n\n This is why we\u2019ve made strategic investments in selective aspects of vertical\n integration over the past couple of years, alongside deepening relationships with\n key strategic partners that we think are best aligned with our long-term\n commercial strategy.\n\n Our investment in commercial infrastructure is starting to deliver real operational\n and financial returns, including with continued volume growth for Illuccix in a\n maturing market landscape. This performance reflects our proven track record in\n commercial execution and I think it positions us very well for future product\n launches.\n\n 242. Defendant Behrenbruch continued:\n\n Let\u2019s take a moment to understand what transitioning from a single product, single\n market company to a multiproduct, multi-region commercial organization actually\n means. It takes a highly complex global manufacturing and distribution\n infrastructure to deliver our precision medicine assets and obviously, future\n therapeutics that are coming down the pathway to patients.\n\n\n 66\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 71 of 90 PageID #:\n 311\n\n\n\n Due to the relatively short half-lives of isotopes and the need for just-in-time\n manufacturing, highly specialized facilities and logistics are required to avoid\n factors throughout the journey that can lead to disruption and delays. We have\n continued investing in our manufacturing infrastructure globally to have greater\n control throughout the process and significantly reduce quality and delivery risk.\n We see this as a crucial point of competitive advantage because without\n reliability, there is no commercial traction in this industry.\n\n 243. Defendants\u2019 statements concerning the Company\u2019s \u201cmanufacturing and supply\n\n chain excellence\u201d by creating \u201cdeepening relationships with key strategic partners\u201d and how that\n\n \u201cposition[ed Telix] very well for future product launches\u201d and gave Telix a \u201ccompetitive\n\n advantage\u201d were materially false and misleading at the time they were made because, as detailed\n\n in Sections IV.D.7 and IV.D.8., Defendants knew that Telix had partnered with GBI and 3DI for\n\n the purported upcoming launch of TLX250 (Zircaix) and that the FDA had already found both of\n\n these Telix partners to be materially deficient in numerous ways such that Telix would not be able\n\n to launch TLX250 (Zircaix) after the PDUFA date at the end of August 2025. Indeed, such\n\n deficiencies in Telix\u2019s manufacturing and supply chain still remain to be fixed and Telix has not\n\n been able to resubmit a BLA for TLX250 (Zircaix).\n\n VI. LOSS CAUSATION\n\n 244. Defendants, as alleged herein, directly and proximately caused Plaintiffs\u2019 and Class\n\n members\u2019 economic loss. During the Class Period, Defendants engaged in a scheme and wrongful\n\n course of business conduct that was designed to, and did, inflate the Company\u2019s stock and ADS\n\n price through attempting to push drug candidates through FDA approval without proper\n\n compliance with FDA requirements, and/or making false and misleading statements about the\n\n Company\u2019s drug candidates without disclosing material facts necessary to render those statements\n\n not false or misleading. Telix\u2019s ADSs traded at artificially inflated prices as a direct result of\n\n Defendants\u2019 materially false and misleading statements, and concealment of the relevant truth\n\n 67\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 72 of 90 PageID #:\n 312\n\n\n\n about Telix\u2019s and Defendants\u2019 fraudulent scheme. Plaintiffs and other Class members purchased\n\n Telix\u2019s ADSs at artificially inflated prices and suffered damages when Telix\u2019s ADS price declined\n\n as the relevant truth entered the market.\n\n 245. As discussed below, the artificial inflation in Telix\u2019s ADS price was dissipated by\n\n partial corrective disclosures on April 28, 2025, July 22, 2025, and August 28, 2025, of new,\n\n Company-specific, material information. The resulting significant ADS price declines upon\n\n release of this new material information, and related increased risks, were due to Company-\n\n specific, fraud-related disclosures, and not a result of macroeconomic or industry factors, or\n\n Company-specific factors unrelated to Defendants\u2019 wrongful conduct.\n\n 246. On April 28, 2025, Telix posted an announcement on its website entitled \u201cTelix\n\n Provides Regulatory Update on TLX101-CDx\u201d announcing the Company had received a Complete\n\n Response Letter from the FDA requiring Telix to provide \u201cadditional confirmatory clinical\n\n evidence\u201d to \u201cprogress the application.\u201d\n\n 247. The market reaction to the announcement was significant. Telix ADSs declined\n\n from a close of $18.80 on April 25, 2025 (the last trading day), to close at $17.57 on the next\n\n trading day April 28, 2025.\n\n 248. Analysts were quick to connect the stock price decline to the announcement of the\n\n CRL. For example, The Motley Fool published an article on the morning of April 28, 2025, titled:\n\n \u201cTelix shares crash 8% on US FDA blow.\u201d Referencing prices of the Australian traded shares, the\n\n article stated:\n\n Telix Pharmaceuticals Ltd(ASX: TLX) shares are tumbling on Monday morning.\n\n At the time of writing, the radiopharmaceuticals company\u2019s shares are down 8% to\n $26.35.\n\n\n 68\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 73 of 90 PageID #:\n 313\n\n\n\n Why are Telix shares sinking?\n\n Investors have been selling the company\u2019s shares today after it was dealt a blow\n from the US Food and Drug Administration (FDA).\n\n According to the release, Telix has received a Complete Response Letter from the\n FDA for its New Drug Application (NDA) for TLX101-CDx (Pixclara). It is an\n investigational agent for the imaging of glioma, a rare and life-threatening brain\n cancer.\n\n 249. The new, Company-specific, material information released on April 28, 2025, was\n\n directly related to the false and/or misleading statements previously made by the Defendants\n\n concerning TLX101 (Pixclara).\n\n 250. On July 22, 2025, before the market opened, Telix issued a press release and filed\n\n with the SEC a current report on Form 6-K. Attached to the current report was a copy of the press\n\n release. In pertinent part, it stated the following:\n\n Telix has received a subpoena from the [SEC] seeking various documents and\n information primarily relating to the Company\u2019s disclosures regarding the\n development of the Company\u2019s prostate cancer therapeutic candidates.\n\n The Company is fully cooperating with the SEC and is in the process of responding\n to the information request. At this stage, this matter is a fact-finding request. The\n Company has elected to notify the Australian Securities and Investments\n Commission of the SEC\u2019s information request. Telix\u2019s policy is not to discuss any\n details of an ongoing regulatory inquiry.\n\n ***\n\n While the matter is ongoing, Telix will continue with its clinical development\n programs relating to its prostate cancer therapy candidates, in the ordinary course\n of business. The information requested does not extend to Telix\u2019s commercial and\n late-stage precision medicine products including Illuccix, Gozellix, Zircaix,\n Pixclara and Scintimun\u00ae[.]\n\n 251. On July 22, 2025, after market close, Bloomberg published an article entitled \u201cTelix\n\n Shares Drop as SEC Probes Disclosures Tied to Prostate Cancer Drug Pipeline.\u201d This article stated\n\n that \u201c[Telix] slumped as much as 16%, the most in 21 months, after the Australian developer of\n\n 69\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 74 of 90 PageID #:\n 314\n\n\n\n radioactive drugs said it received a subpoena from the [SEC] seeking information about disclosures\n\n related to its prostate cancer therapeutic candidates.\u201d\n\n 252. Similarly, The Motley Fool published an article titled \u201cWhy did the Telix share\n\n price just crash 16%?\u201d stating:\n\n Telix share price hit by US subpoena\n\n The Telix share price has come under heavy selling pressure today amid news the\n company has been issued with a subpoena from the United States Securities and\n Exchange Commission (SEC).\n\n As the company reported after market close yesterday, the subpoena involves\n disclosures related to Telix\u2019s prostate cancer therapies.\n\n 253. The SEC\u2019s investigation and subpoena focused primarily on the Company\u2019s\n\n disclosures regarding the development of its prostate cancer therapeutic candidates, specifically\n\n TLX591.\n\n 254. The fact that the SEC served a subpoena upon Telix indicates the SEC was not\n\n merely conducting an informal inquiry but had commenced a formal investigation. The SEC\n\n cannot issue subpoenas without a formal order of investigation. A formal order of investigation\n\n necessarily means the SEC believes Telix may have violated federal securities law.\n\n 255. On this news, Telix ADSs fell $1.70 per ADS, or 10.4%, to close at $14.58 on July\n\n 23, 2025. The next day, Telix ADSs fell a further $0.69 per ADS, or 4.7%, to close at $13.89 on\n\n July 24, 2025.\n\n 256. The new, Company-specific, material information released on July 22, 2025, was\n\n directly related to the false and/or misleading statements previously made by the Defendants\n\n concerning TLX591.\n\n\n\n\n 70\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 75 of 90 PageID #:\n 315\n\n\n\n 257. On the last day of the Class Period August 28, 2025, Telix posted an announcement\n\n on its website informing investors that the FDA had once again rejected its BLA for TLX250. The\n\n press release was entitled \u201cTelix Provides Regulatory Update on TLX250-CDx.\u201d It stated the\n\n following:\n\n Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, \u201cTelix\u201d) today\n announces that it has received a Complete Response Letter (CRL) from the United\n States (U.S.) Food and Drug Administration (FDA) for the Biologics License\n Application (BLA) for TLX250-CDx (Zircaix\u00ae1, 89Zr-DFO-girentuximab), an\n investigational PET2 agent for the diagnosis and characterization of renal masses\n as clear cell renal cell carcinoma (ccRCC).\n\n The CRL identifies deficiencies relating to the Chemistry, Manufacturing, and\n Controls (CMC) package. The FDA has requested additional data to establish\n comparability between the drug product used in the ZIRCON Phase 3 clinical trial\n and the scaled-up manufacturing process intended for commercial use.\n Additionally, the FDA has documented notices of deficiency (Form 483) issued to\n two third-party manufacturing and supply chain partners that will require\n remediation prior to resubmission.\n 1\n Brand name subject to final regulatory approval.\n 2\n Positron emission tomography.\n\n 258. On this news, the price of Telix ADSs fell $1.95 per ADS, or 16.1%, to close at\n\n $10.15 on August 28, 2025. The next day, Telix ADSs fell a further $0.60 per ADS, or 5.9%, to\n\n close at $9.55 on August 29, 2025.\n\n 259. Analysts were quick to link the stock/ADS price decline to the FDA decision on\n\n TLX250 (Zircaix). For example, The Motley Fool published an article titled \u201cTelix shares just\n\n crashed 24%! Here\u2019s why\u201d and reported:\n\n Telix shares tumble on FDA response\n\n Telix shares are taking a tumble after the company announced that it had received\n a Complete Response Letter (CRL) from the United States Food and Drug\n Administration (FDA).\n\n\n\n 71\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 76 of 90 PageID #:\n 316\n\n\n\n The FDA letter addresses Telix\u2019s Biologics License Application (BLA) for its\n TLX250-CDx (Zircaix) product. Zircaix is an investigational positron emission\n tomography (PET) agent intended to diagnose and characterise renal masses as\n clear cell renal cell carcinoma (ccRCC).\n\n As you can likely guess by the plunging Telix share price today, the company\n revealed that the FDA's response identified deficiencies relating to the Chemistry,\n Manufacturing, and Controls (CMC) package.\n\n 260. The new, Company-specific, material information released on August 28, 2025,\n\n was directly related to the false and/or misleading statements previously made by the Defendants\n\n concerning TLX250 (Zircaix).\n\n 261. In sum, as detailed above, Telix\u2019s significant ADS price declines described herein\n\n removed the artificial inflation from the price of Telix ADSs, and were the direct and foreseeable\n\n consequences of the revelations of the relevant truth concealed by Defendants. The declines in the\n\n price of Telix ADSs described herein were a direct result of the nature, extent, and impact of\n\n Defendants\u2019 prior false and misleading statements and omissions being revealed to investors and\n\n the market. The timing and magnitude of the price declines of Telix ADSs negates any inference\n\n that the losses suffered by Plaintiffs and other Class members were caused by changed market\n\n conditions, macroeconomic or industry factors, or Company specific factors unrelated to\n\n Defendants\u2019 wrongful conduct.\n\n 262. As a result of Defendants\u2019 wrongful acts and omissions, and the precipitous decline\n\n in the market value of the Company\u2019s ADSs, Plaintiffs and other Class members have suffered\n\n significant losses and damages.\n\n VII. ADDITIONAL SCIENTER ALLEGATIONS\n\n 263. During the Class Period, Defendant Behrenbruch had both the motive and\n\n opportunity to commit fraud. He also had actual knowledge of the misleading nature of the\n\n statements he made or acted in reckless disregard of the true information known to him at the time.\n 72\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 77 of 90 PageID #:\n 317\n\n\n\n Defendant Behrenbruch participated in conference calls and creating public disclosure documents\n\n and allowed other Telix employees to make false and misleading statements without correcting\n\n those statements. In so doing, Defendant Behrenbruch participated in a scheme to defraud and\n\n committed acts, practices, and participated in a course of business that operated as a fraud or deceit\n\n on purchasers of the Company\u2019s ADSs during the Class Period.\n\n 264. As detailed herein, Telix and Defendant Behrenbruch knew (i) Telix\u2019s TLX101\n\n (Pixclara) drug application to the FDA \u201cdid not provide substantial evidence of effectiveness\u201d (see\n\n \u00a7 IV.B.); (ii) Telix had not obtained FDA approval for a full phase 3 trial of TLX591 (see \u00a7 IV.C.);\n\n and (iii) that Telix\u2019s BLA for TLX250 (Zircaix) had multiple material deficiencies that would\n\n preclude FDA approval (see \u00a7 IV.D.). Accordingly, Defendants\u2019 statements to investors were\n\n made with an intent to deceive investors. A strong inference of Defendants\u2019 scienter is further\n\n supported by the following factors.\n\n A. Defendants Were Motivated to Conceal the Truth While Telix\u2019s Co-\n Founders Sold Four Million Shares\n\n 265. On February 27, 2025, Defendant Behrenbruch and his co-founder Andreas Kluge\n\n sold four million Telix shares for $118 million at the very peak of the Company\u2019s stock price, and\n\n before the shares were cut in half by the disclosures of the truth regarding Telix\u2019s pipeline drugs.\n\n See \u00a7 IV.E.\n\n 266. Defendant Behrenbruch and his co-founder Kluge did not make these sales through\n\n a Rule 10b5-1 trading plan.\n\n 267. Behrenbruch and Kluge sold all four million shares in one transaction via a block\n\n sale \u2013 not over multiple trading days on the open market \u2013 to execute the sale as quickly as possible\n\n and at precisely the peak of the stock price.\n\n\n 73\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 78 of 90 PageID #:\n 318\n\n\n\n 268. Behrenbruch timed his sale shortly after the FDA\u2019s late-cycle meeting with Telix\n\n in which the FDA expressed that the NDA for TLX101 (Pixclara) had substantive application\n\n issues and identified those deficiencies, including: \u201cThe clinical data submitted in this application\n\n did not provide substantial evidence of effectiveness . . . .\u201d See \u00a7 IV.B.\n\n 269. Only two days before he sold shares, Behrenbruch caused Telix to issue a press\n\n release touting that Telix was \u201crecruiting and dosing patients in the ProstACT Global Phase 3 trial\u201d\n\n even though Telix had not been approved for a full Phase 3 trial and Telix had been \u201cactively\n\n dosing patients at multiple clinical trial sites\u201d for months. See \u00a7 IV.C.\n\n 270. Defendant Behrenbruch timed the sale of his shares to occur just one day after Telix\n\n announced the FDA accepted Telix\u2019s BLA for TLX250-CDx (Zircaix) \u2013 which Telix publicized\n\n in a press release that did not disclose (among other things) that Telix employees had presented\n\n Behrenbruch with a presentation of the deficiencies in the BLA that would ultimately cause the\n\n FDA to deny its approval. See \u00a7 IV.D.3.\n\n B. Behrenbruch\u2019s Refusal to Heed Expert Advice Can Best Be Explained by\n Fraudulent Intent\n\n 271. FE-1 left Telix because FE-1 was frustrated that Telix management, particularly\n\n Behrenbruch, refused to heed FE-1 and other experts\u2019 advice.\n\n 272. According to FE-1, Telix management (including Behrenbruch) was dismissive of\n\n Telix\u2019s internal experts and of the FDA\u2019s requests for more information, which put the BLA for\n\n TLX250-CDx at greater risk of being denied.\n\n 273. For example, FE-1 advised Behrenbruch to find an alternative to GBI, but he\n\n refused to do so. Telix conducted a mock inspection of GBI (the company that manufactured the\n\n bioconjugator for TLX250-CDx) in 2024 before Telix resubmitted its BLA to the FDA in\n\n December 2024. Telix discovered numerous deficiencies at GBI. FE-1 recommended that Telix\n 74\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 79 of 90 PageID #:\n 319\n\n\n\n get another manufacturer because FE-1 doubted GBI could fix the deficiencies. Defendant\n\n Behrenbruch refused to do so. Behrenbruch ordered the Telix team to go forward with the\n\n TLX250-CDx BLA regardless of the known serious deficiencies at GBI that would ultimately\n\n result in the BLA being denied.\n\n 274. Similarly, before Telix resubmitted the BLA for TLX250-CDx, Telix employees\n\n told Defendant Behrenbruch they were concerned about the quality of the zirconium provided by\n\n 3DI. Again, according to FE-1, Defendant Behrenbruch simply dismissed these risks: \u201cChris\n\n would justify them himself, [saying] Oh, it\u2019s ok. It\u2019s fine. It\u2019s fine.\u201d \u201cIt didn\u2019t matter what we\n\n said.\u201d \u201cHe was going to say push forward. Don\u2019t worry about it. It\u2019s fine. It was a strange way to\n\n operate.\u201d These risks ultimately resulted in the FDA\u2019s rejection of the TLX250 BLA in August\n\n 2025.\n\n 275. Behrenbruch\u2019s refusal to heed FE-1\u2019s advice to correct the problems with GBI and\n\n 3DI is consistent with Behrenbruch desiring to create the appearance of a successful drug\n\n application to artificially increase the Company\u2019s stock price before he sold shares.\n\n 276. Behrenbruch\u2019s refusal to heed FE-1\u2019s advice was inconsistent with Behrenbruch\n\n acting in the best interests of Telix and inconsistent with his own statements to investors regarding\n\n the market launch of TLX250-CDx.\n\n C. Defendant Behrenbruch was a \u201cVery Hands-on CEO\u201d\n\n 277. FE-1 described Defendant Behrenbruch as \u201ca very hands-on CEO for sure \u2013 he\n\n comes from a science background.\u201d\n\n 278. Further, there can be no doubt that Defendant Behrenbruch had the training and\n\n experience to appreciate the significance of the matters plaguing FDA approval of TLX101\n\n (Pixclara), TLX591, and TLX250-CDx (Zircaix). Behrenbruch has a PhD in biomedical\n\n 75\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 80 of 90 PageID #:\n 320\n\n\n\n engineering from the University of Oxford and over two decades of radiopharmaceutical\n\n experience, including that he founded Telix.\n\n D. Defendant Behrenbruch was Debriefed After Every FDA Meeting\n\n 279. According to FE-1, Telix\u2019s James Stonecypher was the Chief Development Officer\n\n at Telix, and he was in direct communications with the FDA about drugs in the pipeline. According\n\n to FE-1, \u201cJames talked directly to the FDA at every meeting.\u201d\n\n 280. Further, according to FE-1, \u201cAfter every FDA meeting, we would have an\n\n immediate debrief.\u201d Defendant Behrenbruch \u201cwould join these\u201d meetings.\n\n 281. FE-1 was a part of these debriefing meetings.\n\n 282. FE-1 heard Stonecypher report to Behrenbruch the questions and concerns the FDA\n\n had raised.\n\n E. The FDA was in Regular Contact With Telix\n\n 283. The time between submitting an application to the FDA and the FDA\u2019s final\n\n decision on a drug application is not a black box.\n\n 284. To the contrary, the FDA maintains strict requirements for communications to\n\n sponsors of drug applications granted priority review such as Telix\u2019s TLX101-CDx and TLX250-\n\n CDx, which are set forth in the FDA\u2019s \u201cReview Process Desk Reference Guide.\u201d See Ctr. for Drug\n\n Eval. & Rsch., CDER 21st Century Review Process Desk Reference Guide: New Drug Application\n\n and Biologics License Application Reviews (\u201cCDER Review Process\u201d) available at\n\n https://www.fda.gov/media/78941/download.\n\n 285. The CDER Review Process includes a \u201cFormal Communication Plan\u201d with\n\n elements such as mid-cycle communication and late-cycle meetings during NDA/BLA review.\n\n\n\n 76\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 81 of 90 PageID #:\n 321\n\n\n\n 286. Defendants would not have been surprised by the FDA\u2019s decisions, but rather\n\n informed throughout the process of what deficiencies the FDA found problematic to the approval\n\n of Telix\u2019s pipeline drugs.\n\n 287. The formal requirements of the CDER Review Process are consistent with the\n\n account of FE-1, who indicated that Telix met with the FDA a number of times in 2025 to discuss\n\n the FDA\u2019s requests and concerns. \u201cWe had quite a few meetings during the review period with\n\n them trying to address some of their concerns. It was pretty clear in those meetings they [the FDA]\n\n had serious concerns.\u201d\n\n F. Telix\u2019s Pipeline Drugs Were of Critical Importance to the Company\n\n 288. Defendants told investors that the Company\u2019s new drugs in the pipeline \u2013 TLX101-\n\n CDx (Pixclara), TLX591, and TLX250-CDx (Zircaix) \u2013 were very important to the Company\u2019s\n\n future growth. We can thus infer Defendants actually paid attention to what was happening with\n\n these drugs.\n\n 289. For example, in the 2024 Annual Report Behrenbruch wrote to investors that the\n\n Company\u2019s new \u201cstrategy is evident in our execution. We filed three new drug applications for Px\n\n products that have the potential to significantly impact the standard of care while super-charging\n\n Telix\u2019s cash generation capability.\u201d\n\n 290. Given the importance of these new drug applications to Telix, Defendants would\n\n have been most keenly aware of what was going on with them.\n\n VIII. CLASS ACTION ALLEGATIONS\n\n 291. Plaintiffs bring this action as a class action pursuant to Federal Rule of Civil\n\n Procedure 23(a) and (b)(3) on behalf of a class consisting of all persons other than Defendants who\n\n acquired Telix ADSs publicly traded on the NASDAQ during the Class Period, and who were\n\n 77\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 82 of 90 PageID #:\n 322\n\n\n\n damaged thereby (the \u201cClass\u201d). Excluded from the Class are Defendants, the officers and directors\n\n of Telix, members of Defendant Behrenbruch\u2019s immediate family and their legal representatives,\n\n heirs, successors or assigns and any entity in which Defendants have or had a controlling interest.\n\n 292. The members of the Class are so numerous that joinder of all members is\n\n impracticable. Throughout the Class Period, Telix ADSs were actively traded on NASDAQ. While\n\n the exact number of Class members is unknown to Plaintiffs at this time and can be ascertained\n\n only through appropriate discovery, Plaintiffs believe that there are hundreds, if not thousands of\n\n members in the proposed Class.\n\n 293. Plaintiffs\u2019 claims are typical of the claims of the members of the Class as all\n\n members of the Class are similarly affected by Defendants\u2019 wrongful conduct in violation of\n\n federal law that is complained of herein.\n\n 294. Plaintiffs will fairly and adequately protect the interests of the members of the Class\n\n and have retained counsel competent and experienced in class and securities litigation. Plaintiffs\n\n have no interests antagonistic to or in conflict with those of the Class.\n\n 295. Common questions of law and fact exist as to all members of the Class and\n\n predominate over any questions solely affecting individual members of the Class. Among the\n\n questions of law and fact common to the Class are:\n\n \u2022 whether the Exchange Act was violated by Defendants\u2019 acts as alleged herein;\n\n \u2022 whether statements made by Defendants to the investing public during the Class\n\n Period misrepresented material facts about the business and financial condition of\n\n Telix;\n\n\n\n\n 78\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 83 of 90 PageID #:\n 323\n\n\n\n \u2022 whether Defendants\u2019 public statements to the investing public during the Class\n\n Period omitted material facts necessary to make the statements made, in light of the\n\n circumstances under which they were made, not misleading;\n\n \u2022 whether the Defendants caused Telix to issue false and misleading filings during\n\n the Class Period;\n\n \u2022 whether Defendants acted knowingly or recklessly in issuing false filings;\n\n \u2022 whether the prices of Telix ADSs during the Class Period were artificially inflated\n\n because of the Defendants\u2019 conduct complained of herein; and\n\n \u2022 whether the members of the Class have sustained damages and, if so, what is the\n\n proper measure of damages.\n\n 296. A class action is superior to all other available methods for the fair and efficient\n\n adjudication of this controversy since joinder of all members is impracticable. Furthermore, as the\n\n damages suffered by individual Class members may be relatively small, the expense and burden\n\n of individual litigation make it impossible for members of the Class to individually redress the\n\n wrongs done to them. There will be no difficulty in the management of this action as a class action.\n\n 297. Plaintiffs will rely, in part, upon the presumption of reliance established by the\n\n fraud-on-the-market doctrine in that:\n\n \u2022 Telix shares met the requirements for listing, and were listed and actively traded on\n\n NASDAQ, an efficient market;\n\n \u2022 As a public issuer, Telix filed periodic public reports;\n\n \u2022 Telix regularly communicated with public investors via established market\n\n communication mechanisms, including through the regular dissemination of press\n\n releases via major newswire services and through other wide-ranging public\n 79\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 84 of 90 PageID #:\n 324\n\n\n\n disclosures, such as communications with the financial press and other similar\n\n reporting services;\n\n \u2022 Telix\u2019 ADSs were liquid and traded with moderate to heavy volume during the\n\n Class Period; and\n\n \u2022 Telix was followed by a number of securities analysts employed by major\n\n brokerage firms who wrote reports that were widely distributed and publicly\n\n available.\n\n 298. Based on the foregoing, the market for Telix ADSs promptly digested current\n\n information regarding Telix from all publicly available sources and reflected such information in\n\n the prices of the shares, and Plaintiffs and the members of the Class are entitled to a presumption\n\n of reliance upon the integrity of the market.\n\n 299. Alternatively, Plaintiffs and the members of the Class are entitled to the\n\n presumption of reliance established by the Supreme Court in Affiliated Ute Citizens of the State of\n\n Utah v. United States, 406 U.S. 128 (1972), as Defendants omitted material information in their\n\n Class Period statements in violation of a duty to disclose such information as detailed above.\n\n IX. CAUSES OF ACTION\n\n COUNT I\n For Violations of Section 10(b) And Rule 10b-5 Promulgated Thereunder\n Against All Defendants\n\n 300. Plaintiffs repeat and reallege each and every allegation contained above as if fully\n set forth herein.\n 301. This Count is asserted against Defendants is based upon Section 10(b) of the\n Exchange Act, 15 U.S.C. \u00a7 78j(b), and Rule 10b-5 promulgated thereunder by the SEC.\n 302. During the Class Period, Defendants, individually and in concert, directly or\n\n indirectly, disseminated or approved the false statements specified above, which they knew or\n 80\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 85 of 90 PageID #:\n 325\n\n\n\n deliberately disregarded were misleading in that they contained misrepresentations and failed to\n\n disclose material facts necessary in order to make the statements made, in light of the\n\n circumstances under which they were made, not misleading.\n\n 303. Defendants violated \u00a710(b) of the 1934 Act and Rule 10b-5 in that they:\n\n \u2022 employed devices, schemes and artifices to defraud;\n\n \u2022 made untrue statements of material facts or omitted to state material facts\n\n necessary in order to make the statements made, in light of the\n\n circumstances under which they were made, not misleading; or\n\n \u2022 engaged in acts, practices and a course of business that operated as a fraud\n\n or deceit upon Plaintiffs and others similarly situated in connection with\n\n their purchases of Telix ADSs during the Class Period.\n\n 304. Defendants acted with scienter in that they knew that the public documents and\n\n statements issued or disseminated in the name of Telix were materially false and misleading; knew\n\n that such statements or documents would be issued or disseminated to the investing public; and\n\n knowingly and substantially participated, or acquiesced in the issuance or dissemination of such\n\n statements or documents as primary violations of the securities laws. These defendants by virtue\n\n of their receipt of information reflecting the true facts of Telix, their control over, and/or receipt\n\n and/or modification of Telix\u2019 allegedly materially misleading statements, and/or their associations\n\n with the Company which made them privy to confidential proprietary information concerning\n\n Telix, participated in the fraudulent scheme alleged herein.\n\n 305. Defendant Behrenbruch, who is the CEO of the Company, had actual knowledge\n\n of the material omissions and/or the falsity of the material statements set forth above, and intended\n\n to deceive Plaintiffs and the other members of the Class, or, in the alternative, acted with reckless\n\n 81\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 86 of 90 PageID #:\n 326\n\n\n\n disregard for the truth when they failed to ascertain and disclose the true facts in the statements\n\n made by them or other Telix personnel to members of the investing public, including Plaintiffs\n\n and the Class.\n\n 306. As a result of the foregoing, the market price of Telix ADSs was artificially inflated\n\n during the Class Period. In ignorance of the falsity of Defendants\u2019 statements, Plaintiffs and the\n\n other members of the Class relied on the statements described above and/or the integrity of the\n\n market price of Telix ADSs during the Class Period in purchasing Telix ADSs at prices that were\n\n artificially inflated as a result of Defendants\u2019 false and misleading statements.\n\n 307. Had Plaintiffs and the other members of the Class been aware that the market price\n\n of Telix ADSs had been artificially and falsely inflated by Defendants\u2019 misleading statements and\n\n by the material adverse information which Defendants did not disclose, they would not have\n\n purchased Telix ADSs at the artificially inflated prices that they did, or at all.\n\n 308. As a result of the wrongful conduct alleged herein, Plaintiffs and other members\n\n of the Class have suffered damages in an amount to be established at trial.\n\n 309. By reason of the foregoing, Defendants have violated Section 10(b) of the 1934 Act\n\n and Rule 10b-5 promulgated thereunder and are liable to the Plaintiffs and the other members of\n\n the Class for substantial damages which they suffered in connection with their purchase of Telix\n\n ADSs during the Class Period.\n\n COUNT II\n Violations of Section 20(a) of the Exchange Act\n Against Defendant Behrenbruch\n\n 310. Plaintiffs repeat and reallege each and every allegation contained in the foregoing\n\n paragraphs as if fully set forth herein.\n\n\n\n 82\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 87 of 90 PageID #:\n 327\n\n\n\n 311. During the Class Period, Defendant Behrenbruch participated in the operation and\n\n management of Telix, and conducted and participated, directly and indirectly, in the conduct of\n\n Telix\u2019 business affairs. Because of his senior position, he knew the adverse non-public information\n\n about Telix\u2019s business practices.\n\n 312. As an officer and director of a publicly owned company, Defendant Behrenbruch\n\n had a duty to disseminate accurate and truthful information with respect to Telix\u2019 financial\n\n condition and results of operations, and to correct promptly any public statements issued by Telix\n\n which had become materially false or misleading.\n\n 313. Because of his position of control and authority as a senior officer, Defendant\n\n Behrenbruch was able to, and did, control the contents of the various reports, press releases and\n\n public filings which Telix disseminated in the marketplace during the Class Period concerning\n\n Telix\u2019 results of operations. Throughout the Class Period, Defendant Behrenbruch exercised his\n\n power and authority to cause Telix to engage in the wrongful acts complained of herein. He\n\n therefore was a \u201ccontrolling person\u201d of Telix within the meaning of Section 20(a) of the Exchange\n\n Act. In this capacity, they participated in the unlawful conduct alleged which artificially inflated\n\n the market price of Telix ADSs.\n\n 314. By reason of the above conduct, Defendant Behrenbruch is liable pursuant to\n\n Section 20(a) of the Exchange Act for the violations committed by Telix.\n\n X. PRAYER FOR RELIEF\n\n WHEREFORE, Plaintiffs, on behalf of themselves and the Class, pray for judgment and\n relief as follows:\n\n\n\n\n 83\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 88 of 90 PageID #:\n 328\n\n\n\n (a) declaring this action to be a proper class action, certifying Plaintiffs as class\n\n representatives under Rule 23 of the Federal Rules of Civil Procedure and designating Plaintiffs\u2019\n\n counsel as Lead Counsel;\n\n (b) awarding damages in favor of Plaintiffs and the other Class members against all\n\n Defendants, jointly and severally, together with interest thereon;\n\n (c) awarding Plaintiffs and the Class reasonable costs and expenses incurred in this\n\n action, including counsel fees and expert fees; and\n\n (d) awarding Plaintiffs and other members of the Class such other and further relief as\n\n the Court may deem just and proper.\n\n XI. JURY TRIAL DEMANDED\n\n Plaintiffs hereby demand a trial by jury.\n\n\n Dated: April 27, 2026\n\n By:\n Brad A. Catlin, Atty No. 21570-29\n WILLIAMS LAW GROUP, LLC\n 1101 N. Delaware Street\n Indianapolis, IN 46202\n Phone: (317) 633-5270\n brad@williamsgroup.law\n\n Liaison Counsel for co-Lead Plaintiff Song Chee\n Tan and the Class\n\n Phillip Kim (pro hac vice)\n THE ROSEN LAW FIRM, P.A.\n 275 Madison Avenue, 40th Floor\n New York, NY 10016\n Telephone: (212) 686-1060\n Fax: (212) 202-3827\n philkim@rosenlegal.com\n\n\n\n 84\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 89 of 90 PageID #:\n 329\n\n\n\n\n Matthew Siben (pro hac vice)\n THE ROSEN LAW FIRM, P.A.\n 355 South Grand Avenue, Suite 2450\n Los Angeles, CA 90071\n Telephone: (213) 785-2610\n Fax: (213) 226-4684\n msiben@rosenlegal.com\n\n Counsel for co-Lead Plaintiff Song Chee Tan co-\n Lead Counsel for the Class\n\n STOLL KEENON OGDEN PLLC\n Offer Korin, No. 14014-49\n Brooke Smith, No. 32427-0\n 334 N. Senate Avenue\n Indianapolis, IN 46204-1708\n Office: 317-464-100;\n Fax: 317-464-1111\n offer.korin@skofirm.com\n brooke.smith@skofirm.com\n\n Liaison Counsel for co-Lead Plaintiff Tracy Tripp\n and the Class\n\n Charles H. Linehan (pro hac vice to be filed)\n GLANCY PRONGAY & MURRAY LLP\n 1925 Century Park East, Suite 2100\n Los Angeles, CA 90067\n Telephone: (310) 201-9150\n Fax: (310) 201-9160\n clinehan@glancylaw.com\n\n Counsel for co-Lead Plaintiff Tracy Tripp and co-\n Lead Counsel for the Class\n\n Frank R. Cruz (pro hac vice to be filed)\n THE LAW OFFICES OF FRANK R. CRUZ\n 1999 Avenue of the Stars, Suite 1100\n Los Angeles, CA 90067\n Telephone: (310) 914-5007\n\n Additional Counsel for co-Lead Plaintiff Tracy\n Tripp\n\n\n 85\n\fCase 1:25-cv-02299-JRO-MG Document 47 Filed 04/27/26 Page 90 of 90 PageID #:\n 330\n\n\n\n CERTIFICATE OF SERVICE\n\n I hereby certify that on April 27, 2026, a copy of the foregoing Consolidated Complaint\n\n was filed electronically. Service of this filing will be made on all ECF-registered counsel by\n\n operation of the Court\u2019s electronic filing system. Parties may access this filing through the\n\n court\u2019s system.\n\n\n\n\n By:\n Brad A. Catlin, Atty No. 21570-29\n WILLIAMS LAW GROUP, LLC\n 1101 N. Delaware Street\n Indianapolis, IN 46202\n Phone: (317) 633-5270\n brad@williamsgroup.law\n\n\n\n\n 86\n\f","ocr_status":2,"date_upload":"2026-09-22T00:55:37.070285-07:00","document_number":"47","attachment_number":null,"pacer_doc_id":"073011735448","is_available":true,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Amended Complaint","acms_document_guid":""},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/494519487/","id":494519487,"tags":[],"absolute_url":"/docket/71895569/47/1/thomas-v-telix-pharmaceuticals-ltd/","date_created":"2026-09-22T00:55:08.786613-07:00","date_modified":"2026-09-22T00:55:08.786636-07:00","sha1":"","page_count":6,"file_size":790138,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"47","attachment_number":1,"pacer_doc_id":"073011735449","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":2,"description":"Exhibit Exhibit A - TLX101 CRL","acms_document_guid":""},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/494519488/","id":494519488,"tags":[],"absolute_url":"/docket/71895569/47/2/thomas-v-telix-pharmaceuticals-ltd/","date_created":"2026-09-22T00:55:08.878728-07:00","date_modified":"2026-09-22T00:55:08.878754-07:00","sha1":"","page_count":20,"file_size":1467691,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"47","attachment_number":2,"pacer_doc_id":"073011735450","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":2,"description":"Exhibit Exhibit B - TLX250 CRL","acms_document_guid":""},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/494519489/","id":494519489,"tags":[],"absolute_url":"/docket/71895569/47/3/thomas-v-telix-pharmaceuticals-ltd/","date_created":"2026-09-22T00:55:08.901396-07:00","date_modified":"2026-09-22T00:55:08.901418-07:00","sha1":"","page_count":7,"file_size":2701445,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"47","attachment_number":3,"pacer_doc_id":"073011735451","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":2,"description":"Exhibit Exhibit C - GBI Form 483","acms_document_guid":""},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/494519490/","id":494519490,"tags":[],"absolute_url":"/docket/71895569/47/4/thomas-v-telix-pharmaceuticals-ltd/","date_created":"2026-09-22T00:55:08.924051-07:00","date_modified":"2026-09-22T00:55:08.924080-07:00","sha1":"","page_count":53,"file_size":29923432,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"47","attachment_number":4,"pacer_doc_id":"073011735452","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":2,"description":"Exhibit Exhibit D - GBI Est. Inspect Report","acms_document_guid":""},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/494519491/","id":494519491,"tags":[],"absolute_url":"/docket/71895569/47/5/thomas-v-telix-pharmaceuticals-ltd/","date_created":"2026-09-22T00:55:08.946139-07:00","date_modified":"2026-09-22T00:55:08.946167-07:00","sha1":"","page_count":8,"file_size":4454305,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"47","attachment_number":5,"pacer_doc_id":"073011735453","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":2,"description":"Exhibit Exhibit E - 3DI Form 486 06.2025","acms_document_guid":""}],"date_created":"2026-04-27T14:07:06.365013-07:00","date_modified":"2026-08-12T20:24:11.384295-07:00","date_filed":"2026-04-27","time_filed":"16:52:41","entry_number":47,"recap_sequence_number":"2026-04-27.001","pacer_sequence_number":158,"description":"AMENDED COMPLAINT Consolidated Class Action Complaint for Violations of the Federal Securities Laws against All Defendants, filed by All Plaintiffs. (Attachments: # 1 Exhibit Exhibit A - TLX101 CRL, # 2 Exhibit Exhibit B - TLX250 CRL, # 3 Exhibit Exhibit C - GBI Form 483, # 4 Exhibit Exhibit D - GBI Est. Inspect Report, # 5 Exhibit Exhibit E - 3DI Form 486 06.2025)(Catlin, Brad) (Entered: 04/27/2026)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/457427408/","id":457427408,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/71895569/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/472411744/","id":472411744,"tags":[],"absolute_url":"/docket/71895569/46/thomas-v-telix-pharmaceuticals-ltd/","date_created":"2026-03-17T09:26:00.380908-07:00","date_modified":"2026-04-26T23:40:56.699783-07:00","sha1":"","page_count":null,"file_size":null,"filepath_local":null,"filepath_ia":"","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"","ocr_status":null,"date_upload":null,"document_number":"46","attachment_number":null,"pacer_doc_id":"073011651464","is_available":false,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Practices and Procedures","acms_document_guid":""}],"date_created":"2026-03-17T09:26:00.357189-07:00","date_modified":"2026-04-26T23:40:56.667827-07:00","date_filed":"2026-03-17","time_filed":"11:25:36","entry_number":46,"recap_sequence_number":"2026-03-17.001","pacer_sequence_number":156,"description":"PRACTICES AND PROCEDURES before District Judge Justin R. Olson. (Morrison, Griffen) (Entered: 03/17/2026)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/455840290/","id":455840290,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/71895569/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/470793880/","id":470793880,"tags":[],"absolute_url":"/docket/71895569/45/thomas-v-telix-pharmaceuticals-ltd/","date_created":"2026-03-04T13:28:34.558738-08:00","date_modified":"2026-05-22T04:01:14.911228-07:00","sha1":"f674df91c8561acb75e30e981a40cdd6f3e5f5ce","page_count":1,"file_size":264469,"filepath_local":"recap/gov.uscourts.insd.225663/gov.uscourts.insd.225663.45.0.pdf","filepath_ia":"https://archive.org/download/gov.uscourts.insd.225663/gov.uscourts.insd.225663.45.0.pdf","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"Case 1:25-cv-02299-JRO-MG Document 45 : Filed 03/04/26 Page 1 of 1 PageID #: 220\n\n\n\n IN THE UNITED STATES DISTRICT COURT\n FOR THE SOUTHERN DISTRICT OF INDIANA\n INDIANAPOLIS DIVISION\n\n\n\n JOHN THOMAS, Individually and On Behalf of All\n Others Similarly Situated,\n\n Plaintiff,\n\n vs. Case No.: 1:25-cv-02299-JRO-MG\n\n TELIX PHARMACEUTICALS LTD., CHRISTIAN P.\n BEHRENBRUCH, DARREN SMITH, and KYAHN\n WILLIAMSON,\n\n Defendants.\n\n\n ORDER\n\n The Court, having reviewed the Joint Motion Regarding Schedule for Filing Consolidated\n\n Complaint and Motion(s) to Dismiss and being duly advised, hereby GRANTS the Motion.\n\n IT IS THEREFORE ORDERED that (i) Plaintiffs shall file a Consolidated Complaint\n\n on or before April 27, 2026; (ii) Defendants shall file answer(s) or motion(s) to dismiss the\n\n Consolidated Complaint on or before June 26, 2026; (iii) Plaintiffs shall file opposition brief(s) to\n\n any motion(s) to dismiss on or before August 25, 2026; and (iv) Defendants shall file reply brief(s)\n\n in support of any motion(s) to dismiss on or before October 9, 2026.\n\n IT IS SO ORDERED.\n\n Date: 3/4/2026\n\n\n Ma r\n ioGa r\n cia\n Unit\n e dSta\n tesMa gi\n st\n rateJudge\n Souther\n nDi s\n tri\n ctofIndia\n na\n\n\n\n Service on all ECF-registered counsel via email generated by the Court\u2019s ECF system.\n\f","ocr_status":2,"date_upload":"2026-05-18T09:41:12.455865-07:00","document_number":"45","attachment_number":null,"pacer_doc_id":"073011627805","is_available":true,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Order on Motion","acms_document_guid":""}],"date_created":"2026-03-04T13:28:34.525854-08:00","date_modified":"2026-04-26T23:40:56.595777-07:00","date_filed":"2026-03-04","time_filed":"15:41:52","entry_number":45,"recap_sequence_number":"2026-03-04.001","pacer_sequence_number":154,"description":"ORDER granting 44 Joint Motion Regarding Schedule for Filing Consolidated Complaint and Motion(s) to Dismiss - IT IS THEREFORE ORDERED that (i) Plaintiffs shall file a Consolidated Complaint on or before April 27, 2026; (ii) Defendants shall file answer(s) or motion(s) to dismiss the Consolidated Complaint on or before June 26, 2026; (iii) Plaintiffs shall file opposition brief(s) to any motion(s) to dismiss on or before August 25, 2026; and (iv) Defendants shall file reply brief(s) in support of any motion(s) to dismiss on or before October 9, 2026. Signed by Magistrate Judge Mario Garcia on 3/4/2026. (AAS) (Entered: 03/04/2026)","tags":[]},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/docket-entries/455671176/","id":455671176,"docket":"https://www.courtlistener.com/api/rest/v4/dockets/71895569/","recap_documents":[{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/470620191/","id":470620191,"tags":[],"absolute_url":"/docket/71895569/44/thomas-v-telix-pharmaceuticals-ltd/","date_created":"2026-03-03T11:18:29.328314-08:00","date_modified":"2026-05-22T03:57:27.604683-07:00","sha1":"310064b4b04983a382e9904d0ec3eeb27e868288","page_count":4,"file_size":184887,"filepath_local":"recap/gov.uscourts.insd.225663/gov.uscourts.insd.225663.44.0.pdf","filepath_ia":"https://archive.org/download/gov.uscourts.insd.225663/gov.uscourts.insd.225663.44.0.pdf","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"Case 1:25-cv-02299-JRO-MG Document 44 Filed 03/03/26 Page 1 of 4 PageID #: 215\n\n\n\n UNITED STATES DISTRICT COURT\n SOUTHERN DISTRICT OF INDIANA\n INDIANAPOLIS DIVISION\n\n\n JOHN THOMAS, Individually and On Behalf of All\n Others Similarly Situated,\n Case No.: 1:25-cv-02299-JRO-MG\n Plaintiff,\n JOINT MOTION REGARDING\n vs.\n SCHEDULE FOR FILING\n CONSOLIDATED COMPLAINT\n TELIX PHARMACEUTICALS LTD., CHRISTIAN P.\n AND MOTION(S) TO DISMISS\n BEHRENBRUCH, DARREN SMITH, and KYAHN\n WILLIAMSON,\n\n Defendants.\n\n\n\n Defendants Telix Pharmaceuticals Ltd., Christian Behrenbruch, Darren Smith, and Kyahn\n\nWilliamson (\u201cDefendants\u201d) and Court-appointed co-Lead Plaintiffs Song Chee Tan and Tracy Tripp\n\n(\u201cPlaintiffs\u201d) respectfully request that the Court enter an order governing the filing of Plaintiffs\u2019\n\nConsolidated Complaint and Defendants\u2019 anticipated motion(s) to dismiss. In support of this motion,\n\nDefendants and Plaintiffs state the following:\n\n 1. On November 10, 2025, Plaintiff John Thomas in the above-captioned action (the\n\n\u201cAction\u201d) filed a putative class action complaint alleging claims against Defendants pursuant to\n\nSections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended by the Private Securities\n\nLitigation Reform Act, 15 U.S.C. \u00a7 78u-4 et seq. (the \u201cPSLRA\u201d).\n\n 2. In accordance with the PSLRA, the Court appointed co-Lead Plaintiffs on February 24,\n\n2026, and, on that same date, ordered Plaintiffs and Defendants to meet and confer within fourteen\n\n(14) days and \u201csubmit a proposed schedule for the filing of a consolidated and/or amended complaint\n\nand for Defendants\u2019 anticipated motion(s) to dismiss.\u201d (ECF No. 43 at 6.)\n\n 3. The Parties have met and conferred.\n\fCase 1:25-cv-02299-JRO-MG Document 44 Filed 03/03/26 Page 2 of 4 PageID #: 216\n\n\n\n WHEREFORE, Plaintiffs and Defendants respectfully request that the Court enter an order\n\nproviding that (i) Plaintiffs shall file a Consolidated Complaint on or before April 27, 2026; (ii)\n\nDefendants shall file answer(s) or motion(s) to dismiss the Consolidated Complaint on or before June\n\n26, 2026; (iii) Plaintiffs shall file opposition brief(s) to any motion(s) to dismiss on or before August\n\n25, 2026; and (iv) Defendants shall file reply brief(s) in support of any motion(s) to dismiss on or\n\nbefore October 9, 2026.\n\nDated: March 3, 2026 Respectfully submitted,\n\n\n\n By: /s/ Nilofer Umar By: /s/ Brad S. Catlin\n Nilofer Umar (pro hac vice) Brad A. Catlin, Atty No. 21570-29\n Heather Benzmiller Sultanian (pro hac vice) WILLIAMS LAW GROUP, LLC\n SIDLEY AUSTIN LLP 1101 N. Delaware Street\n One South Dearborn Street Indianapolis, IN 46202\n Chicago, IL 60603 Phone: (317) 633-5270\n Telephone: (312) 853-7000 brad@williamsgroup.law\n Fax: (312) 853-7036\n numar@sidley.com Liaison Counsel for co-Lead Plaintiff Song Chee Tan\n hsultanian@sidley.com and the Class\n\n Jacob V. Bradley Phillip Kim (pro hac vice)\n Lucy R. Dollens THE ROSEN LAW FIRM, P.A.\n QUARLES & BRADY LLP 275 Madison Avenue, 40th Floor\n 135 N. Pennsylvania St., Suite 2400 New York, NY 10016\n Indianapolis, IN 46204 Telephone: (212) 686-1060\n Telephone: (317) 957-5000 Fax: (212) 202-3827\n Fax: (317) 957-5010 philkim@rosenlegal.com\n jacob.bradley@quarles.com\n lucy.dollens@quarles.com Matthew Siben (pro hac vice)\n THE ROSEN LAW FIRM, P.A.\n Counsel for Telix Pharmaceuticals Ltd. 355 South Grand Avenue, Suite 2450\n Christian Behrenbruch, Darren Smith, and Los Angeles, CA 90071\n Kyahn Williamson Telephone: (213) 785-2610\n Fax: (213) 226-4684\n msiben@rosenlegal.com\n\n Counsel for co-Lead Plaintiff Song Chee Tan co-\n Lead Counsel for the Class\n\n\n\n\n 2\n\fCase 1:25-cv-02299-JRO-MG Document 44 Filed 03/03/26 Page 3 of 4 PageID #: 217\n\n\n\n STOLL KEENON OGDEN PLLC\n Offer Korin, No. 14014-49\n Brooke Smith, No. 32427-0\n 334 N. Senate Avenue\n Indianapolis, IN 46204-1708\n Office: 317-464-100;\n Fax: 317-464-1111\n offer.korin@skofirm.com\n brooke.smith@skofirm.com\n\n Liaison Counsel for co-Lead Plaintiff Tracy Tripp and\n the Class\n\n GLANCY PRONGAY & MURRAY LLP\n Charles H. Linehan (pro hac vice to be filed)\n 1925 Century Park East, Suite 2100\n Los Angeles, CA 90067\n Telephone: (310) 201-9150;\n Fax: (310) 201-9160\n clinehan@glancylaw.com\n\n Counsel for co-Lead Plaintiff Tracy Tripp and co-\n Lead Counsel for the Class\n\n THE LAW OFFICES OF FRANK R. CRUZ\n Frank R. Cruz (pro hac vice to be filed)\n 1999 Avenue of the Stars, Suite 1100\n Los Angeles, CA 90067\n Telephone: (310) 914-5007\n\n Additional Counsel for co-Lead Plaintiff Tracy\n Tripp\n\n\n\n\n 3\n\fCase 1:25-cv-02299-JRO-MG Document 44 Filed 03/03/26 Page 4 of 4 PageID #: 218\n\n\n\n\n CERTIFICATE OF SERVICE\n\n I hereby certify that on March 3, 2026, a copy of the foregoing Joint Motion Regarding Schedule\n\nfor Filing Consolidated Complaint and Motion(s) For Dismissal was filed electronically. Service of this\n\nfiling will be made on all ECF-registered counsel by operation of the court's electronic filing system.\n\nParties may access this filing through the court's system.\n\n /s/ Brad A. Catlin\n Brad A. Catlin\n Williams Law Group, LLC\n 1101 N. Delaware Street\n Indianapolis, IN 46202\n Phone: (317) 633-5270\n Fax: (317) 426-3348\n\n\n\n\n 4\n\f","ocr_status":2,"date_upload":"2026-05-18T09:41:15.521206-07:00","document_number":"44","attachment_number":null,"pacer_doc_id":"073011624455","is_available":true,"is_free_on_pacer":null,"is_sealed":null,"document_type":1,"description":"Motion (Other)","acms_document_guid":""},{"resource_uri":"https://www.courtlistener.com/api/rest/v4/recap-documents/479567044/","id":479567044,"tags":[],"absolute_url":"/docket/71895569/44/1/thomas-v-telix-pharmaceuticals-ltd/","date_created":"2026-05-18T09:41:14.852132-07:00","date_modified":"2026-05-22T04:29:47.466505-07:00","sha1":"1a06390fa5995eae61d11f69582db3c29b743a4c","page_count":1,"file_size":119675,"filepath_local":"recap/gov.uscourts.insd.225663/gov.uscourts.insd.225663.44.1.pdf","filepath_ia":"https://archive.org/download/gov.uscourts.insd.225663/gov.uscourts.insd.225663.44.1.pdf","ia_upload_failure_count":null,"thumbnail":null,"thumbnail_status":0,"plain_text":"Case 1:25-cv-02299-JRO-MG Document 44-1 Filed 03/03/26 Page 1 of 1 PageID #:\n 219\n\n\n\n IN THE UNITED STATES DISTRICT COURT\n FOR THE SOUTHERN DISTRICT OF INDIANA\n INDIANAPOLIS DIVISION\n\n\n JOHN THOMAS, Individually and On Behalf of All\n Others Similarly Situated,\n\n Plaintiff,\n\n vs. Case No.: 1:25-cv-02299-JRO-MG\n\n TELIX PHARMACEUTICALS LTD., CHRISTIAN P.\n BEHRENBRUCH, DARREN SMITH, and KYAHN\n WILLIAMSON,\n\n Defendants.\n\n\n [PROPOSED] ORDER\n\n The Court, having reviewed the Joint Motion Regarding Schedule for Filing Consolidated\n\n Complaint and Motion(s) to Dismiss and being duly advised, hereby GRANTS the Motion.\n\n IT IS THEREFORE ORDERED that (i) Plaintiffs shall file a Consolidated Complaint\n\n on or before April 27, 2026; (ii) Defendants shall file answer(s) or motion(s) to dismiss the\n\n Consolidated Complaint on or before June 26, 2026; (iii) Plaintiffs shall file opposition brief(s) to\n\n any motion(s) to dismiss on or before August 25, 2026; and (iv) Defendants shall file reply brief(s)\n\n in support of any motion(s) to dismiss on or before October 9, 2026.\n\n IT IS SO ORDERED this ____ day of _________________, 2026.\n\n\n Hon. Justin R. Olson\n United States District Judge\n Southern District of Indiana\n\n Service on all ECF-registered counsel via email generated by the Court\u2019s ECF system.\n\f","ocr_status":2,"date_upload":"2026-05-18T09:41:28.854660-07:00","document_number":"44","attachment_number":1,"pacer_doc_id":"073011624456","is_available":true,"is_free_on_pacer":null,"is_sealed":null,"document_type":2,"description":"Text of Proposed Order","acms_document_guid":""}],"date_created":"2026-03-03T11:18:29.300350-08:00","date_modified":"2026-04-26T23:40:56.529026-07:00","date_filed":"2026-03-03","time_filed":"13:21:28","entry_number":44,"recap_sequence_number":"2026-03-03.001","pacer_sequence_number":149,"description":"Joint MOTION Regarding Schedule for Filing Consolidated Complaint and Motion(s) to Dismiss, filed by Plaintiff SONG CHEE TAN. 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