Anavex Life Sciences Reports Fiscal 2022 Year End Financial Results and Provides Business Update
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:AVXL), a clinical-stage biopharmaceutical company developingdifferentiated therapeutics for the treatment of neurodegenerativeand neurodevelopmental disorders including Alzheimer’s disease,Parkinson’s disease, Rett syndrome and other central nervous system(CNS) diseases, today reported financial results for its fiscalyear ended September 30, 2022.
“This is an exciting time in neuroscience andrare disease drug development and we remain on track for thereadout of the placebo-controlled ANAVEX®2-73 Phase 2b/3Alzheimer’s disease clinical trial, a condition of significantunmet need and economic burden for which there are only limitedapproved pharmacological treatment options,” said Christopher UMissling, PhD, President and Chief Executive Officer of Anavex.“Our recent progress highlights the potential of our clinicalPrecision Medicine SIGMAR1 platform and portfolio, and we lookforward to sharing additional program and data updates.”
ANAVEX®2-73 Program and other Near-TermPipeline Data Updates:
- Late breakingoral communication presentation of top line data of randomized,double-blind, multicenter, placebo-controlled Phase 2b/3 studyANAVEX®2-73-AD-004 for the treatment of early Alzheimer’s diseaseat the upcoming Clinical Trials on Alzheimer’s Disease (CTAD)Congress 2022, December 1, 2022, at 4:30pm PT in San Francisco,CA.
- Nearing theenrollment completion of the randomized, placebo-controlledEXCELLENCE Phase 2/3 study ANAVEX®2-73-RS-003 for the treatment ofpediatric patients with Rett syndrome.
- Guidancereceived from the FDA confirms the Company’s strategy to advanceANAVEX®2-73 for the treatment of Fragile X syndrome in adouble-blind, randomized, placebo-controlled Phase 2/3 developmentprogram.
- UpcomingPipeline expansion of the ANAVEX platform using gene biomarkers ofresponse and applying precision medicine for treatment ofneurological disorders with high unmet medical need are expected:
- Meeting with FDAto discuss ANAVEX®2-73 Parkinson’s disease program includingpivotal Phase 3 study.
- Plannedinitiation of ANAVEX®2-73 imaging-focused Parkinson’s diseaseclinical study.
- Plannedinitiation of a Phase 2/3 clinical trial for the treatment of a newrare-disease indication.
- Plannedinitiation of ANAVEX®3-71 Phase 2 clinical trial forschizophrenia.
Recent Business Highlights:
- Anavex announceda peer-reviewed publication in the journal of Science TranslationalMedicine, titled “Widespread cell stress and mitochondrialdysfunction occur in patients with early Alzheimer’s disease”,which provided further scientific evidence of the relevance ofsigma-1 receptor (SIGMAR1) activation as a compensatory mechanismto chronic CNS diseases.
- Anavex announcedthat the United States Patent and Trademark Office (USPTO) issuedU.S. Patent No. 11,446,275 to Anavex, with claims to treatmentmethods using its leading drug candidate, ANAVEX®2-73(blarcamesine) and its analogs, for amelioratingbiochemical and functional abnormalities associated with methyl-CpGbinding protein 2 defects (MeCP2 defects). Such defects encompass arange of neurodevelopmental and neurological disorders, includingbut not limited to, Rett syndrome, Angelman syndrome, Williamssyndrome, cerebral palsy, autism spectrum disorder, and multiplesclerosis.
- Anavex announcedthat the U.S. Food and Drug Administration (FDA) granted OrphanDrug Designation (ODD) to ANAVEX®2-73 (blarcamesine) forthe treatment of Fragile X syndrome. Fragile X syndrome is the mostcommon form of inherited intellectual disability and the mostfrequent single gene cause of autism spectrum disorder with anestimated population of approximately 62,500 in the US and1,088,500 worldwide.1
Financial Highlights:
- Cash and cashequivalents of $149.2 million at September 30, 2022, compared to$152.1 million at September 30, 2021.
- Net loss for thefourth quarter of $14.3 million, or $0.18 per share, compared to anet loss of $11.7 million, or $0.15 per share for the same periodin fiscal 2021.
- Net loss for the full fiscal yearended September 30, 2022 of $48.0 million, or $0.62 per compared tonet loss of $37.9 million, or $0.54 per share for the full fiscal2021 year.
- Research anddevelopment expenses for the fourth quarter of $11.4 millioncompared to $9.4 million for the same period in fiscal 2021.
- General andadministrative expenses of $3.9 million for fiscal 2022 compared to$2.9 million for the comparable quarter of fiscal 2021.
The financial information for the fiscal yearended September 30, 2022, should be read in conjunction with theCompany’s consolidated financial statements, which will appear onEDGAR, www.sec.gov and will be available on the Anavex website atwww.anavex.com.
Webcast / Conference Call Information:
Management will host a conference call today at 8:30 am ET. Thelive webcast of the conference call will be available on Anavex’swebsite at www.anavex.com.
The conference call can be also accessed bydialing +1 929 205 6099 for participants in the U.S. using thereference passcode 511901. A replay of the conference call willalso be available on Anavex’s website for up to 30 days.
Economic Burden of Alzheimer’sDisease2
Alzheimer’s disease is the most common cause ofdementia and the fifth leading cause of death in adults older than65 years. The estimated total healthcare costs for the treatment ofAlzheimer disease in 2020 is estimated at $305 billion, with thecost expected to increase to more than $1 trillion as thepopulation ages. Most of the direct costs of care for Alzheimer’sdisease are attributed to skilled nursing care, home healthcare,and hospice care. Indirect costs of care, including quality of lifeand informal caregiving, are likely underestimated and areassociated with significant negative societal and personalburden.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is apublicly traded biopharmaceutical company dedicated to thedevelopment of novel therapeutics for the treatment ofneurodegenerative and neurodevelopmental disorders, includingAlzheimer's disease, Parkinson's disease, Rett syndrome, and othercentral nervous system (CNS) diseases, pain, and various types ofcancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine),has successfully completed a Phase 2a clinical trial forAlzheimer's disease, a Phase 2 proof-of-concept study inParkinson's disease dementia, and both a Phase 2 and a Phase 3study in adult patients with Rett syndrome. ANAVEX®2-73 is anorally available drug candidate that restores cellular homeostasisby targeting sigma-1 and muscarinic receptors. Preclinical studiesdemonstrated its potential to halt and/or reverse the course ofAlzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant,anti-amnesic, neuroprotective, and anti-depressant properties inanimal models, indicating its potential to treat additional CNSdisorders, including epilepsy. The Michael J. Fox Foundation forParkinson's Research previously awarded Anavex a research grant,which fully funded a preclinical study to develop ANAVEX®2-73 forthe treatment of Parkinson's disease. ANAVEX®3-71, which targetssigma-1 and M1 muscarinic receptors, is a promising clinical stagedrug candidate demonstrating disease-modifying activity against themajor hallmarks of Alzheimer's disease in transgenic (3xTg-AD)mice, including cognitive deficits, amyloid, and tau pathologies.In preclinical trials, ANAVEX®3-71 has shown beneficial effects onmitochondrial dysfunction and neuroinflammation. Furtherinformation is available at www.anavex.com. You can also connectwith the company on Twitter, Facebook, Instagram, and LinkedIn.
Forward-Looking Statements
Statements in this press release that are notstrictly historical in nature are forward-looking statements. Thesestatements are only predictions based on current information andexpectations and involve a number of risks and uncertainties.Actual events or results may differ materially from those projectedin any of such statements due to various factors, including therisks set forth in the Company’s most recent Annual Report on Form10-K filed with the SEC. Readers are cautioned not to place unduereliance on these forward-looking statements, which speak only asof the date hereof. All forward-looking statements are qualified intheir entirety by this cautionary statement and Anavex LifeSciences Corp. undertakes no obligation to revise or update thispress release to reflect events or circ*mstances after the datehereof.
| Anavex LifeSciences Corp. | |||||||||||||
| ConsolidatedStatements of Operations and Comprehensive Loss | |||||||||||||
| (Unaudited -Expressed in US Dollars) | |||||||||||||
| Three monthsended September 30, | Years endedSeptember 30, | ||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||
| Operating Expenses | |||||||||||||
| General andadministrative | $ | 3,902,508 | $ | 2,878,983 | $ | 13,070,068 | $ | 9,017,511 | |||||
| Research anddevelopment | 11,381,450 | 9,372,786 | 37,915,747 | 32,983,674 | |||||||||
| Total operating expenses | 15,283,958 | 12,251,769 | 50,985,815 | 42,001,185 | |||||||||
| Operating loss | (15,283,958 | ) | (12,251,769 | ) | (50,985,815 | ) | (42,001,185 | ) | |||||
| Other income (expenses) | |||||||||||||
| Grantincome | - | - | - | 54,100 | |||||||||
| Research anddevelopment incentive income | 994,336 | 953,243 | 3,323,011 | 4,547,099 | |||||||||
| Interestincome, net | 704,583 | 7,151 | 946,988 | 26,261 | |||||||||
| Foreignexchange (loss) gain, net | (495,070 | ) | (284,535 | ) | (903,611 | ) | (267,344 | ) | |||||
| Total other income, net | 1,203,849 | 675,859 | 3,366,388 | 4,360,116 | |||||||||
| Net lossbefore provision for income taxes | (14,080,109 | ) | (11,575,910 | ) | (47,619,427 | ) | (37,641,069 | ) | |||||
| Income taxexpense, current | (210,291 | ) | (142,296 | ) | (358,492 | ) | (267,565 | ) | |||||
| Netloss and comprehensive loss | $ | (14,290,400 | ) | $ | (11,718,206 | ) | $ | (47,977,919 | ) | $ | (37,908,634 | ) | |
| Net loss pershare | |||||||||||||
| Basic and diluted | $ | (0.18 | ) | $ | (0.15 | ) | $ | (0.62 | ) | $ | (0.54 | ) | |
| Weightedaverage number of shares outstanding | |||||||||||||
| Basic and diluted | 77,442,470 | 75,714,558 | 76,909,993 | 69,802,960 | |||||||||
| Anavex LifeSciences Corp. | ||||||||
| Consolidated BalanceSheets | ||||||||
| At September 30,2022 and 2021 | ||||||||
| Expressed in US Dollars | ||||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current | ||||||||
| Cash andcash equivalents | $ | 149,157,861 | $ | 152,107,745 | ||||
| Incentiveand tax receivables | 3,192,580 | 9,136,831 | ||||||
| Prepaidexpenses and other current assets | 354,162 | 371,914 | ||||||
| Total Assets | $ | 152,704,603 | $ | 161,616,490 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current Liabilities | ||||||||
| Accountspayable | $ | 3,824,777 | $ | 4,739,781 | ||||
| Accruedliabilities | 5,944,953 | 5,614,774 | ||||||
| Deferredgrant income | 443,831 | 443,831 | ||||||
| Total Liabilities | 10,213,561 | 10,798,386 | ||||||
| CapitalStock | 77,944 | 75,920 | ||||||
| Additionalpaid-in capital | 387,976,881 | 348,328,048 | ||||||
| Accumulateddeficit | (245,563,783 | ) | (197,585,864 | ) | ||||
| Total Stockholders' Equity | 142,491,042 | 150,818,104 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 152,704,603 | $ | 161,616,490 | ||||
For FurtherInformation:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com
____________________________
1https://fragilex.org/understanding-fragile-x/fragile-x-101/prevalence/
2 W Wong Economic Burden of Alzheimer Disease andManaged Care Considerations Am J Manag Care.2020;26:S177-S183
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(\u201cAnavex\u201d or the \u201cCompany\u201d) (Nasdaq: AVXL), a clinical-stage...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93844480\/anavex-life-sciences-to-present-at-the-h-c-wainwr","source":"GlobeNewswire Inc.","source_logo":"\/common\/images\/news-sources\/globe.png","tags":[],"timestamp":1715686200,"date":"Tue May 14, 2024 ","time":"7:30 AM (1 month ago)","full_date":"May 14, 2024 7:30 AM","post_time":"May 14 2024","article_id":93844480,"source_id":"globe","media_url":null,"press_release":true},{"headline":"Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More","short_text":" Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More\nPR Newswire\nNEW YORK, May 10, 2024 NEW YORK, May 10...","one_line_short_text":" Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More\nPR...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93822893\/shareholders-that-lost-money-on-anavex-life-scienc","source":"PR Newswire (US)","source_logo":"\/common\/images\/news-sources\/prnus.png","tags":[],"timestamp":1715334300,"date":"Fri May 10, 2024 ","time":"5:45 AM (1 month ago)","full_date":"May 10, 2024 5:45 AM","post_time":"May 10 2024","article_id":93822893,"source_id":"prnus","media_url":null,"press_release":true},{"headline":"Form 10-Q - Quarterly report [Sections 13 or 15(d)]","short_text":"","one_line_short_text":"","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93818920\/form-10-q-quarterly-report-sections-13-or-15d","source":"Edgar (US Regulatory)","source_logo":"\/common\/images\/news-sources\/edgar2.png","tags":["REGULATORY"],"timestamp":1715286955,"date":"Thu May 09, 2024 ","time":"4:35 PM (1 month ago)","full_date":"May 9, 2024 4:35 PM","post_time":"May 09 2024","article_id":93818920,"source_id":"edgar2","media_url":null,"press_release":true},{"headline":"Form 8-K - Current report","short_text":"","one_line_short_text":"","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93814389\/form-8-k-current-report","source":"Edgar (US Regulatory)","source_logo":"\/common\/images\/news-sources\/edgar2.png","tags":["REGULATORY"],"timestamp":1715256030,"date":"Thu May 09, 2024 ","time":"8:00 AM (1 month ago)","full_date":"May 9, 2024 8:00 AM","post_time":"May 09 2024","article_id":93814389,"source_id":"edgar2","media_url":null,"press_release":true},{"headline":"Anavex Life Sciences Reports\u00a0Fiscal 2024 Second Quarter Financial Results and Provides Business Update","short_text":"Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK, May 09, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (\u201cAnavex\u201d or the \u201cCompany\u201d) (Nasdaq: AVXL), a clinical-stage...","one_line_short_text":"Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK, May 09, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (\u201cAnavex\u201d or...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93813665\/anavex-life-sciences-reports-fiscal-2024-second-qu","source":"GlobeNewswire Inc.","source_logo":"\/common\/images\/news-sources\/globe.png","tags":[],"timestamp":1715254200,"date":"Thu May 09, 2024 ","time":"7:30 AM (1 month ago)","full_date":"May 9, 2024 7:30 AM","post_time":"May 09 2024","article_id":93813665,"source_id":"globe","media_url":null,"press_release":true},{"headline":"The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Anavex Life Sciences Corporation(AVXL) Shareholders","short_text":" The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Anavex Life Sciences Corporation(AVXL) Shareholders\nPR Newswire\nNEW YORK, May 7, 2024 NEW YORK, May 7, 2024...","one_line_short_text":" The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Anavex Life Sciences Corporation(AVXL) Shareholders\nPR...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93789431\/the-gross-law-firm-announces-the-filing-of-a-secur","source":"PR Newswire (US)","source_logo":"\/common\/images\/news-sources\/prnus.png","tags":[],"timestamp":1715075100,"date":"Tue May 07, 2024 ","time":"5:45 AM (1 month ago)","full_date":"May 7, 2024 5:45 AM","post_time":"May 07 2024","article_id":93789431,"source_id":"prnus","media_url":null,"press_release":true},{"headline":"Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material","short_text":"","one_line_short_text":"","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93781112\/form-defa14a-additional-definitive-proxy-solicit","source":"Edgar (US Regulatory)","source_logo":"\/common\/images\/news-sources\/edgar2.png","tags":["REGULATORY"],"timestamp":1714989813,"date":"Mon May 06, 2024 ","time":"6:03 AM (1 month ago)","full_date":"May 6, 2024 6:03 AM","post_time":"May 06 2024","article_id":93781112,"source_id":"edgar2","media_url":null,"press_release":true},{"headline":"Anavex Life Sciences Corporation Sued for Securities Law Violations - Contact The Gross Law Firm Before May 13, 2024 to Discuss Your Rights - AVXL","short_text":" Anavex Life Sciences Corporation Sued for Securities Law Violations - Contact The Gross Law Firm Before May 13, 2024 to Discuss Your Rights - AVXL\nPR Newswire\nNEW YORK, May 3, 2024 NEW YORK, May...","one_line_short_text":" Anavex Life Sciences Corporation Sued for Securities Law Violations - Contact The Gross Law Firm Before May 13, 2024 to Discuss Your Rights...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93774016\/anavex-life-sciences-corporation-sued-for-securiti","source":"PR Newswire (US)","source_logo":"\/common\/images\/news-sources\/prnus.png","tags":[],"timestamp":1714729500,"date":"Fri May 03, 2024 ","time":"5:45 AM (1 month ago)","full_date":"May 3, 2024 5:45 AM","post_time":"May 03 2024","article_id":93774016,"source_id":"prnus","media_url":null,"press_release":true},{"headline":"Anavex Life Sciences to Announce Fiscal 2024 Second Quarter Financial Results\u00a0on Thursday, May 9th, 2024","short_text":"NEW YORK, May 02, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (\u201cAnavex\u201d or the \u201cCompany\u201d) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated...","one_line_short_text":"NEW YORK, May 02, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (\u201cAnavex\u201d or the \u201cCompany\u201d) (Nasdaq: AVXL), a clinical-stage...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/anavex-life-sciences-AVXL\/stock-news\/93766233\/anavex-life-sciences-to-announce-fiscal-2024-secon","source":"GlobeNewswire Inc.","source_logo":"\/common\/images\/news-sources\/globe.png","tags":[],"timestamp":1714649400,"date":"Thu May 02, 2024 ","time":"7:30 AM (2 months ago)","full_date":"May 2, 2024 7:30 AM","post_time":"May 02 2024","article_id":93766233,"source_id":"globe","media_url":null,"press_release":true}],"Preferred Contributors": ""}},created: function () {this.loaded = true;Vue.nextTick(function(){});}});});
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