Case 1:24-cv-03529-CM Document 23-5 Filed 08/23/24 Page 1 of 13 Case 1:24-cv-03529-CM Document 23-5 Filed 08/23/24 Page 2 of 13 EXHIBIT 99.1 Forward Looking Statement This presentation contains forward-looking statements made within the meaning of the Private Securities Litigation Reform Act of 1995 by Anave x® Life Sciences Corp. and its representatives. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates, " "forecasts ," "projects," or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual resu lts to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in reports filed by Anavex Life Sciences Corp. with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Anavex Life Sciences Corp. undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise . Anavex Life Sciences Corp. cannot be sure when or if it will be permitted by regulatory agencies to undertake clinical trials or to commence any particular phase of any clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Anavex Life Sciences Corp. will obtain regulatory approval for any "phase" of clinical trials. We also cannot be sure of the clinical outcome for efficacy or safety of our compounds. Potential investors should refer to the risk factors in our reports filed on Edgar. anavex 2 Case 1:24-cv-03529-CM Document 23-5 Filed 08/23/24 Page 3 of 13 What is Rett Syndrome? Devastating Neuro-developmental Disease in Girls with both Movement Impairment and Cogn t ve Impairment Rett Syndrome (RTT) • Non-Inherited genetic postnatal disorder caused by mutations In the MECP2 gene Occurs almost exclusively in girls Leads to severe impairments, affecting nearly every aspect of the child's life Impairment includes ability to speak, walk, eat and even breathe easily Hallmark of RTT is near constant repetitive hand movements while awake Occurs worldwide in approximately one in every 10,000 to 15,000 live female births The population of patients with Rett syndrome is estimated to be -11,000 patients in the U.S. There is currently no cure for Rett syndrome Source: https:llwww.rettsy11ti-0 HQ d dcee ongoing Week 0 Week 4 Week 7 (Base line) (End of Trial [E OT] ) Assessments: Primary: Assessment of RSBQ AUC response and safety • Secondary: Emotional behavior (ADAMS) response and CGl-1 (Clinical Global Impression of Improvement) response • Exploratory: Sleep (CSHQ), VAS (top caregiver concerns), Child Health Questionnaire PFSO (CHQ-PFSO), Rett syndrome Caregiver Inventory Assessment (RTT-CIA), Seizure diary • Biomarkers of response and/or surrogate endpoints: DNA & mRNA profiles and metabolomics biomarkers SIGMAR1 variants: Prespecified analyses of population with wi ld type (WT) variant CfinfcBITriBls.gov: NCT0394 1444 Separate paUenl co/Jori (n=3) underwent " 3-weeh inlensi"" ph1Jm>acok1netic (PK) assessment wlfh s1Jfely, toiembiMy. phann,,colII P. Validity of area-under-the-curve analysis lo summarize effect in rheumatoid arthritis c/10,ca/ lna/s. J Rheumalol. 1999;26(3):712-716. anavex CG -1 Scale crn·cal Glob I lmpress·on of l11provem t (CGl-1) The Clinical Global Impression of Improvemen t Scale (CGl-I) is a measure developed for use in clinical trials to provide a brief. stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. Each time the patient is seen after medication has been initiated. the clinician compares the patient's overall clinical condition to the period just prior to the initiation of medication use (the so-called baseline visit).' Mimics what a physician would do in practice if an intervention is helping Measure both global and individual domain ratings like CGI-S (Clinical Global Impression of Severity) CGl-I measures clinical change in a "Very Much Worse" (7 score) to "Very Much Improved" (1 score) range The CGI-S score obtained at the baseline (initiation) visit serves as a good basis for making this assessment The following question is rated on a seven-point scale: ·compared to the patient's condition at admission to the project [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse: l=very much worse since the initiation of treatment.·· Only scores of 1 or 2 or 3 are defined as treatment "responders" Score of 3 or less represent clearly observable clinically meaningful manifestation of drug effect This implies that the minimal important difference is a change of 1 unit from a CGl-1 of 4 (no change) to a CGl-I of 3 (minimal improvement) iltillllll=El1ll1l·II Il X 7 X 6 X 5 X 4 " 3 "2 T "1 Very Much Much Mi nimally Minima lly Much Very M uch No Change Worse Wors e Wor:se Im p roved lmp,oved Im proved ' Busner J, T8fgtim SD. The cliroca/ global impressions scale.· applying a research loo/ in cl,mca/ practice. Psychiatry (Edgroonl), 2007;4(7):28-37, 10 Case 1:24-cv-03529-CM Document 23-5 Filed 08/23/24 Page 7 of 13 ADAMS Scale Anxiety, Depression, and Mood Scale (ADAMS) The Anxiety, Depression, and Mood Scale (ADAMS) is a measure of anxiety and mood symptoms in individuals with intellectual disability. 1 It has been clinically validated for use in Rett syndrome 2 and in Fragile X syndrome 3 The ADAMS generates a total score and 5 subscale scores: Manic/hyperactive behavior Depressed mood Social avoidance General anxiety Obsessive compulsive behavior 1) Esbensen AJ, Roja Im J, Amen MG, Ruedlicll S. Reliability and validity of an assessme/l/ 1ns/romen/ tor anxiety, depression, and mood among individuals with ment,,t retardatioo. J Autism Dev D,sord. 2003;33:617-29 K!u""'r Academ,c Publishers-Plenum Publishers. 2) Bames KV; Coughlin FR, O'Lea,y HM, Bruck N, Baz,n GA, &in<>cke EB, Walco AC, Cantwell NG, Kaufmann WE. Anri<>ty-llke l)ehavK)I" in Reff syndrome: characterislics and assessment t,y anxiety scales, J Neurodev Disord, 2015;7(1):30, do,; 10, 11Ws11689-0115-9127-4 Epub 2015 Sep 15. 3) Corr:leiro L. Ballinger E, Hi!!J6rman R. Hess/ D. Clinical assessment of DSM-IV anxo,ty disorders in fra,}ila >< syndrome: prevalanca and charar;terizali-On. J Neurodev Disord. 2011;3.57-oT. do/: 10.1007/s11689.()10•~7-y. Epub 2010 Dec 3. anav _ 11 Primary Endpoint Primary Efficacy Endpoint 80 72.2 70 p = 0037 38.S 10 ANAVEX2-73 Placebo ANAVEX®2-73 induces a clinical meaningful improvement of RSBQ AUC* in 72.2% of patients as compared to 38.5% on placebo; (p = 0.037) Cohen's d effect size 1.91 (very large) "Improvement tl,reshold of al leas/ 1 full point in the CGl-1 scale from 'No Change ' (I.e .. 4) to at least 'Minimally Improved' (I.e., 3) or 'Much Improved' (I.e.. 2) or 'Ve,y Much Improved · (i.e .. 1) :vex 12 Case 1:24-cv-03529-CM Document 23-5 Filed 08/23/24 Page 8 of 13 Secondary Endpoints Secondary Efficacy Endpoints ADAMS and CGl-1 . 80 72.l "' 70 "' . '7 Lo ;::- 60 p = 0.010 p = 0.037 ,. 40 38.5 ,. §. 30 20 a u IO 10 0 ANil.'a'flQ -73 pi.c.,t,(> A.NA\IE:Q•73 Clinically meaningful and statistically significant reduction of Significantly more patients achieve clinically meaningful CGl-I emotional behavioral symptoms (ADAMS) response• for response'* over the treatment duration in ANAVEX®2-73-treated ANAVEX®2-73 treated adult patients with Rett syndrome (52 .9%) group (72.2%) as compared with placebo (38.5%); (p = 0.037) vs placebo (8.3%); (p = 0.010) Cohen 's d effect size 1.91 (very large) Cohen's d effect size 0.609 (large) • /mprow,meol I/iresllold o/ al /eaS/ -20% c/Jar,ge (lmprovemenl) o/ ADAMS Iota/ •• Improve men/ lhreshold of al least 1 full point in /he CGl-1 scale from 'No Change· scorn from baseline (i.e., 4) lo al leas/ 'Minimally Improved· (1.e., 3) or "Much Improved' (i.e., 2) or 'Ve,y a Much Improved' /i.e., 1) 13 Other Endpoints Quality of Life (QoL) Assessment and Distribution of Seizure Count by Treatment Arm ANAVEX2-73 Placebo Child Health Questionnaire-Parent Form 50 (CHQ-PF50) The CHQ-PF50 is an internationally recognized general health-related 60- global measure of Quality of Life (Qol) encompassing physical and Treatment psychosocial concepts (physical ANAVEX2-73 function , psychosocial, behavior, bodily Plocebo pain, emotional impact, family activities, family cohesion, and general 20- health perception) ANAVEX®2-73 demonstrated dose- related significant improvement in o- • • • 0 2'5 5'0 75 I) 2'5 50 75 . overall Quality of Life (Qol) measured Seizure counts with CHQ-PF50 Total Score (p = 0.030) ANAVEX®2-73 is associated with a 50.7% reduction in weekly seizure risk :vex 14 Case 1:24-cv-03529-CM Document 23-5 Filed 08/23/24 Page 9 of 13 Biomarkers Increase Probability of Success Precision Medicine 76% Patient selection biomarkers 55% 46% Higher therapeutic response 28% Lower variability in the target population Phase 11to Phase Il l Phase Ill to NDNBLA • Without Bi oma rkers Wi lh Patient Selecti on Biomarkers Thomas DWel 81. CJ,nicaJ Development Sucoess RB/es 2006-2015. BIO Industry Analysis anavex 15 ANAVEX®2-73 Mechanism of Action for Rett Syndrome SIG AR1 Activation is e efcial i Restoring Neuronal Homeostasis MECP2 mutation alters S/GMAR1 act1vatlon closes ANAVEX®2-73 reverses synaptic development and chromatin to counteract ch ron,c behaviora l, motor, and drives ch ronic cellu lar stress cell ular stress, restoring synaptic imbalances by by open ing chromatin 1,2 mitochondria and synapses 3.4 activating StGMAR1s. 6 7.a, ! l;',:.~:;'i:;::.:~ MECP2 Aberrant Expression Synaptic Balance V Mitochondrial Function f Inflammation Synaptogenesis M,tochondnal Function l l 1nflammat1on GABA Neurotrophic Factors l (BONF) Seizures Neurodegeneration Markers (L-AAA) 1/ U et o/.. 2020; 2) Wang eta/ 2020; 3/ Crouzieret o/., 2020: 4/ Lee el al, 2020; 5) Kaufmann et a/, 2019; ij/ Kaolmann el al , 201!11;,; 7) Lahmy el al, 2015; ~) Lioak el al., 2020; 9) ANAVfaX2-7J-R$-002 Dalo :vex 16 Case 1:24-cv-03529-CM Document 23-5 Filed 08/23/24 Page 10 of 13 GABA a Potential Biomarker, Predicting Clinical Outcome in ANAVEX®2-73 Rett Syndrome Study In patients with RTT. MECP2 • AVATAR efficacy endpoints deficiency disrupts the demonstrated statistically significant and clinically meaningful reductions GABAergic cycle 1, resulting in in Rett syndrome symptoms with decreased GABA, and impaired related changes in potential synaptic and mitochondrial biomarkers of disease pathology: fu net ion 1.2,3,4.5,s • GABA7was significantly increased (p = 0.0205) GAIAP;athw;rys Otli1t1illll!llo - Onli-mfl • Gliotoxin L-Alpha-aminoadipic acid (L-AAA) 8 was significantly decreased (p = 0.0392) 1) Jin et Bl., 2015: 2) Chao et Bl., 2020: 3) HBmbergeret Bl. , 1992: 4) l..appB/Binen et Bl., 1996; 5) Neu/ et al., 2020 6) KBufmBnn et Bl., 2005 7} U,e K, Lu H, Wang W, el Bl. RestornlHJn of Meq,2 express,oo m GABAe,gic neurons ,s sufficient to rescue mu/~ple disease featu,es m a mouse model of Rett syndrome. Elite 2016 Jun 21;5:e 14198; 8) Wu HQ, Ungerste.3'}' kll'Phre!Dklglcal llra,11 plaebcty In m,oe Ellf ~europ,;yd,oph;mn.,CDI 2(120 Od:39 29-45 l1ol 10 1016,lj i:tJrnn~uro 2020 08 010 tt.,r.tshi T Su TP" Si.ginit-1 r~~pklr d1.:1pero11es.itl 1t11~ ERr11irocho11drion inl.t!rfit0e regul.:!!e Ca(2•)s~n!!tmy 1111d ot!ll surviv~ Cell. 2007 No~ 2 131(3).596-610. doi. 10.1D16.•j ~1.2007.08.03.EI l(eufmM'ln WE S~IJlie J. Retl0'""9 N. Haner,111 T Klami;ir D. Mlsslil'l!J CU ANA'VEX©2-f3.(tllercarn9illl4!/. a Sl!lma-1 r909Ptor 9gonl&t Bn1ellQJate& n0vrok)glc1mp miB'f!tEi In a mou:e,,e m:idl;ll Flelti;~mtome Ph1nm:2col Biochcr11 Beh;:i-.,_ 2019 187.17279113 dai. 10.1D1EI~ pbb.2019. 172796 l(aufmann WE. Pett:-/ A¥. Lane JB. OD8fl'Tl1111 LM Touta,n S. F«iroch JA, ~IS611ng CU Treelrn~of Aet1 &:;ndrome ..,.,th the :sigma-1 recep1orblareame&lne prel1n,r1111")' effcacyanaty.&es lnadul15 NORD R11re Di~.:12!1 zmd Orpho,m Producl.!i 6r~k1!1rough Surrir11il (1:1bslntct/, Oe1olit!1 2t-22 20Hfu W1t!ihlr1glon.. 0 C Lahmy V, Loog Fl. Mc,rin D Vd~ V, "'1aur,ce T. toctlondrl&I prol&etlon by lhe mlJ:edmo&CllftOO'o1 Ilg.and A.NAVEX2-73, a 1e-trah)'iittll'uren l8. J NeurCNmmWlAd~. J Neoroscl. 2015 Feb 11,J5161.2516-29 001. 10.1523/JNEUROSCl.277B-14.2D15 K.,ufrn.1Tifl WE. Jotin,;ton Ml/, Blut1 r,.i E Mr.CP2 r-xprr-.,;~il)lt .ind frJnr.tion d.1ring br.a'1 dcvr.Jopmr.nt implc.1bon~ ftir Rr.tt ,;:,nliromr."s p,,ittiogr.nr.:-.,~ ;md cinir~ r.,v,oiuhOfl Br.iin Or.y 2005 t,,lcw 27 SuFJ!I 1·S77-S87 1101 10 1016,'j 1>ra1n<1e~.2~.1D.008 Lappalain,en Fl R kon&n RS Hl;ih leYel& of oeretro&p nal lluh:t ~tamale In Rett &"~l'l(JtOIJ'le Pedl~r Neurol 1996 Oct H,{3}21~ dol· 10 1016ts08Bt-8994({)6)0021S-4 N~ul JL SJw,n~ SA. Armet1e f Lane J. Ht!yder11i:iru1 P' Jare11, M, Kl!Ufn'll!lnn WE Gl.:!Lt! P ~ AK M~labolil: Siyna!ure11, Difft!~nlii:ill!I Rt!l! Syndron,e frcrn UrllLffl!ld.t!d Slilir,g11, Frcr1I lnlft!Jf ~rD:M:i. 2020 Ft!b 2~14·/ dol· 1033,8.9,'tn,nt2:02000001 dn~vex •4