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Anavex Life Sciences (AVXL) - 2023 Q2 - Quarterly Report

PART I FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS This section presents unaudited interim consolidated financial statements, including balance sheets, statements of operations, equity changes, and cash flows, with notes on business and accounting policies Condensed Interim Consolidated Balance Sheets Total assets increased to $159.2 million at March 31, 2023, from $152.7 million at September 30, 2022, driven by cash and cash equivalents, with liabilities and equity also rising Condensed Interim Consolidated Balance Sheets | Metric | March 31, 2023 | September 30, 2022 | | :-------------------------------- | :------------- | :----------------- | | Cash and cash equivalents | $153,466,962 | $149,157,861 | | Total Assets | $159,186,397 | $152,704,603 | | Total Liabilities | $14,021,343 | $10,213,561 | | Total Stockholders' Equity | $145,165,054 | $142,491,042 | Condensed Interim Consolidated Statements of Operations Net loss increased for both three and six months ended March 31, 2023, primarily due to higher operating expenses, especially research and development, despite increased other income Condensed Interim Consolidated Statements of Operations | Metric | 3 Months Ended Mar 31, 2023 | 3 Months Ended Mar 31, 2022 | 6 Months Ended Mar 31, 2023 | 6 Months Ended Mar 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Total operating expenses | $14,189,159 | $11,519,747 | $29,573,114 | $23,243,137 | | Operating loss | $(14,189,159) | $(11,519,747) | $(29,573,114) | $(23,243,137) | | Total other income, net | $1,131,880 | $1,111,736 | $3,524,071 | $1,982,739 | | Net loss | $(13,107,279) | $(10,437,811) | $(26,078,997) | $(21,320,178) | | Net Loss per share (Basic and diluted) | $(0.17) | $(0.14) | $(0.33) | $(0.28) | Condensed Interim Consolidated Statements of Changes in Stockholders' Equity Stockholders' equity increased from $142.5 million to $145.2 million due to additional paid-in capital from common stock issuances and stock-based compensation, partially offset by net loss Condensed Interim Consolidated Statements of Changes in Stockholders' Equity | Metric | Balance, Oct 1, 2022 | Balance, Mar 31, 2023 | | :-------------------------------- | :------------------- | :-------------------- | | Common Stock Par Value | $77,944 | $80,236 | | Additional Paid-in Capital | $387,976,881 | $416,727,598 | | Accumulated Deficit | $(245,563,783) | $(271,642,780) | | Total Stockholders' Equity | $142,491,042 | $145,165,054 | - Shares issued under 2023 purchase agreement: 2.15 million shares for $18.15 million19 - Share based compensation: $9.32 million for the six months ended March 31, 202319 - Net loss for the six months ended March 31, 2023: $(26.08) million19 Condensed Interim Consolidated Statements of Cash Flows Net cash used in operating activities increased to $14.3 million for the six months ended March 31, 2023, while cash provided by financing activities rose to $18.6 million from common share issuances, leading to a $4.3 million increase in cash and cash equivalents Condensed Interim Consolidated Statements of Cash Flows | Metric | 6 Months Ended Mar 31, 2023 | 6 Months Ended Mar 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | | Net cash used in operating activities | $(14,282,836) | $(13,140,439) | | Net cash provided by financing activities | $18,591,937 | $14,375,250 | | Increase in cash and cash equivalents | $4,309,101 | $1,234,811 | | Cash and cash equivalents, end of period | $153,466,962 | $153,342,556 | - Issuance of common shares: $18.15 million in 2023 vs $14.40 million in 202221 Notes to the Condensed Interim Consolidated Financial Statements This section provides detailed explanations and disclosures for the interim consolidated financial statements, covering business, accounting policies, liquidity, estimates, and specific financial items Note 1 Business Description Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company developing precision medicine for CNS diseases, with lead compound ANAVEX2-73 targeting Alzheimer's, Parkinson's, Rett, and Fragile X syndromes - Clinical stage biopharmaceutical company developing precision medicine for CNS diseases23 - Lead compound: ANAVEX2-73, targeting Alzheimer's, Parkinson's, Rett syndrome, and Fragile X syndrome23 Note 2 Basis of Presentation Unaudited interim consolidated financial statements are prepared under SEC rules and U.S. GAAP, with management believing current working capital is sufficient for 12 months, while consolidating subsidiaries and using estimates - Financial statements are unaudited and prepared under SEC rules and U.S. GAAP for interim reporting24 - Management believes current working capital is sufficient to meet requirements beyond the next 12 months29 - The company has not generated any revenues from operations and expects negative cash flows for the foreseeable future27 - Consolidates Anavex Australia, Anavex Germany GmbH, and Anavex Canada Ltd32 Note 3 Other Income Grant income of $25,000 and R&D incentive income of $1.48 million were recognized for the six months ended March 31, 2023, with the latter decreasing from the prior year Other Income | Income Type | 3 Months Ended Mar 31, 2023 | 3 Months Ended Mar 31, 2022 | 6 Months Ended Mar 31, 2023 | 6 Months Ended Mar 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Grant income | $0 | $0 | $25,000 | $0 | | Research and development incentive income | $749,681 | $835,513 | $1,483,271 | $1,646,243 | - Received $0.50 million of a $1.00 million Michael J. Fox Foundation grant during the six months ended March 31, 202340 - Deferred grant income at March 31, 2023: $0.92 million (September 30, 2022: $0.44 million)42 Note 4 Accrued Liabilities Total accrued liabilities increased to $6.8 million at March 31, 2023, from $5.9 million, driven by clinical site costs, compensation, and milestone-based contract accruals Accrued Liabilities | Accrued Liability Component | March 31, 2023 | September 30, 2022 | | :-------------------------------- | :------------- | :----------------- | | Accrued clinical site and patient visits costs | $2,168,950 | $2,031,105 | | Accrued compensation and benefits | $1,572,500 | $1,297,337 | | Milestone based contract accruals | $1,041,930 | $137,337 | | Total accrued liabilities | $6,822,838 | $5,944,953 | Note 5 Equity Offerings The company entered a new $150 million Purchase Agreement in February 2023, issuing 2.16 million common shares for $18.2 million during the period, with $131.8 million remaining available, while no shares were sold under the previous Sales Agreement - Entered into a $150 million Purchase Agreement with Lincoln Park Capital Fund, LLC on February 3, 2023, valid for three years53 - Issued 75,000 common shares as an initial commitment fee for the Purchase Agreement, valued at $0.84 million54 - Issued 2.16 million common shares under the 2023 Purchase Agreement for an aggregate purchase price of $18.15 million during the six months ended March 31, 202355 - $131.85 million remained available under the 2023 Purchase Agreement as of March 31, 202355 - No shares sold under the Sales Agreement during the six months ended March 31, 202352 Note 6 Commitments and Contingencies Office lease expenses and 401(k) contributions increased, with 160,000 share purchase warrants outstanding. Stock-based compensation expense rose to $9.3 million, with $21.8 million expected through fiscal 2026, and 14.8 million options outstanding - Office lease expense for six months ended March 31, 2023: $60,140 (2022: $21,333)58 - 401(k) matching contributions for six months ended March 31, 2023: $99,876 (2022: $93,622)59 - 160,000 share purchase warrants outstanding at March 31, 2023, with a weighted average exercise price of $3.726162 - Stock-based compensation expense for six months ended March 31, 2023: $9.32 million (2022: $8.35 million)7374 - Approximately $21.78 million in stock-based compensation expected to be recorded through fiscal 202674 - Outstanding stock options at March 31, 2023: 14.84 million shares with a weighted average exercise price of $6.9769 - Exercisable stock options at March 31, 2023: 9.94 million shares with a weighted average exercise price of $4.7869 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. Management discusses financial condition, operations, forward-looking statements, business, clinical trials, pipeline, target indications, IP, and financial performance for Q1 and H1 2023 vs 2022 Forward-Looking Statements The report contains forward-looking statements on clinical milestones, financial position, strategy, and operations, subject to risks and uncertainties detailed in the 'Risk Factors' section of the annual report - Report contains forward-looking statements about future clinical/regulatory milestones, financial position, business strategy, and operations79 - Statements are subject to risks and uncertainties, including those in the "Risk Factors" section of the Annual Report on Form 10-K80 Our Current Business Anavex is a clinical-stage biopharmaceutical company developing precision medicine for CNS diseases, with ANAVEX2-73 as its lead candidate, and a portfolio of SIGMAR1-activating compounds - Clinical-stage biopharmaceutical company developing precision medicine for CNS diseases83 - Utilizes genomic data to identify biomarkers for clinical trials83 - Lead product candidate: ANAVEX2-73, for Alzheimer's, Parkinson's, Rett syndrome, and other CNS diseases83 - Portfolio of compounds varying in sigma-1 receptor (SIGMAR1) binding activities, aiming to restore cellular homeostasis8487 Clinical Trials Overview Anavex provides an overview of clinical trials for ANAVEX2-73 in Alzheimer's, Rett, and Parkinson's, and ANAVEX3-71 in FTD, emphasizing a precision medicine approach with genomic biomarkers - ANAVEX2-73-specific Biomarkers: Genomic analysis in Alzheimer's trials identified actionable genetic variants (SIGMAR1, COMT) impacting drug response, supporting a precision medicine approach89 - Alzheimer's Disease: Completed Phase 2a trial met primary and secondary endpoints90 Completed Phase 2b/3 trial met co-primary endpoints (ADAS-Cog, ADCS-ADL) and key secondary endpoint (CDR-SB), showing ANAVEX2-73 slowed cognitive and functional decline9294 Patients treated with ANAVEX2-73 had 1.84 times higher odds to improve cognitively (p=0.015) and 2.67 times higher odds to improve function (p=0.0255) compared to placebo95 An open-label extension study (ATTENTION-AD) is ongoing95 - Rett Syndrome: Positive preclinical data96 Completed Phase 2 trial (ANAVEX2-73-RS-001) showed statistically significant improvements in RSBQ (p=0.011) and CGI-I (p=0.014)98 Completed Phase 3 AVATAR trial (ANAVEX2-73-RS-002) met all primary and secondary efficacy and safety endpoints101 EXCELLENCE trial (Phase 2/3 in pediatric patients) completed enrollment in February 2023, with topline results expected in H2 2023102 - Parkinson's Disease: Positive preclinical data103 Completed Phase 2 proof-of-concept trial showed ANAVEX2-73 was safe, well-tolerated, and resulted in clinically meaningful, dose-dependent, and statistically significant improvements in CDR computerized assessment and MDS-UPDRS total score104105 Preliminary data from the 48-week Open Label Extension (OLE) trial demonstrated longitudinal beneficial effects108 Awarded a $1.0 million research grant from The Michael J. Fox Foundation in January 2021109 - Frontotemporal Dementia (FTD): ANAVEX3-71 granted orphan drug designation by the FDA110 Completed First-in-Human Phase 1 trial met primary and secondary endpoints for safety, tolerability, and PK111112 Intends to advance ANAVEX3-71 into a biomarker-driven clinical development dementia program for schizophrenia, FTD, and Alzheimer's disease113 Our Pipeline Anavex's SIGMACEPTOR™ Discovery Platform generates small molecule drug candidates, primarily through sigma-1 receptor activation, for neurodegenerative and neurodevelopmental diseases, including ANAVEX2-73, ANAVEX3-71, ANAVEX1-41, ANAVEX1066, and ANAVEX1037 - Proprietary SIGMACEPTOR™ Discovery Platform produces small molecule drug candidates targeting sigma receptors116 - ANAVEX2-73 (blarcamesine): Disease-modifying approach by activating SIGMAR1 for neurodegenerative and neurodevelopmental diseases117 Granted Orphan Drug Designation by FDA for Rett syndrome (May 2016) and infantile spasms (June 2016)119 Granted Rare Pediatric Disease (RPD) designation for Rett syndrome (November 2019) and Fast Track designation for Rett syndrome clinical development (February 2020)128130 Preclinical data supports use in epilepsy, infantile spasms, Fragile X syndrome, Angelman syndrome, multiple sclerosis, and tuberous sclerosis complex (TSC)131132 - ANAVEX3-71: Clinical drug candidate with novel mechanism via SIGMAR1 activation and M1 muscarinic allosteric modulation133 Demonstrated disease-modifying activity against Alzheimer's hallmarks in preclinical studies134 Granted Orphan Drug Designation for FTD by FDA (April 2016)134 - ANAVEX1-41: Sigma-1 agonist showing significant neuroprotective benefits by modulating endoplasmic reticulum, mitochondrial, and oxidative stress138 - ANAVEX1066: Mixed sigma-1/sigma-2 ligand designed for neuropathic and visceral pain, showing rapid and significant efficacy in preclinical models139 - ANAVEX1037: Designed for prostate and pancreatic cancer, exhibiting high affinity for SIGMAR1 and moderate for sigma-2 receptors, showing antitumor potential in preclinical studies140 Our Target Indications Anavex is developing compounds for CNS diseases like Alzheimer's, Parkinson's, Rett syndrome, Fragile X, Depression, and Epilepsy, as well as for Cancer indications including Neuropathic Pain, Malignant Melanoma, Prostate Cancer, and Pancreatic Cancer - Central Nervous System Diseases: Alzheimer's disease (6.7 million Americans age 65+ in 2023, urgent unmet need)144 Parkinson's disease (10 million+ worldwide, market expected to reach $11.5 billion by 2029)145 Rett syndrome (1 in 10,000-15,000 females, severe impairments)146 Fragile X syndrome (1:4,000 males, 1:6,000-8,000 females, intellectual disability/autism)147 Depression (global antidepressant market projected to $21 billion by 2030)148 Epilepsy (3.4 million Americans in 2015, need for combination drugs)149 - Cancer: Neuropathic Pain (difficult to treat)151 Malignant Melanoma (worldwide market expected to grow to $7.5 billion by 2029)152 Prostate Cancer (drug therapeutics market expected to increase to $10.1 billion by 2030)152 Pancreatic Cancer (global pharmaceutical treatment market predicted to reach $3.73 billion by 2027)152 Patents, Trademarks and Intellectual Property Anavex holds 18 U.S. patents, 21 U.S. patent applications, and international applications covering its drug candidates and research programs for various CNS disorders and cancer, actively protecting its intellectual property - Holds 18 U.S. patents, 21 U.S. patent applications, and various international applications153 - Patents cover ANAVEX2-73 compositions, crystalline forms, and methods for neuroprotection, Alzheimer's, seizure treatment, neurodevelopmental disorders, cardiac dysfunction, insomnia/anxiety, and melanoma154156 - Patents for ANAVEX2-73 and related compounds are expected to expire between 2030 and 2039154156 - Owns two U.S. patents for ANAVEX1066 related to pain treatment, expiring in November 2036157 - Owns exclusive rights to two U.S. patents for ANAVEX3-71 compound and methods of treating diseases, expiring in April 2030 and January 2030158 - Protects intellectual property through filings and confidentiality agreements159 Financial Overview Anavex is a development-stage company with no revenue since 2004, anticipating revenue only upon establishing alliances, with operating costs primarily driven by research and development and general and administrative expenses - Development-stage company with no revenue since 2004162 - Anticipates revenue only after establishing alliances for product development or marketing162 - Operating costs primarily consist of research and development (clinical trials, manufacturing, personnel) and general and administrative expenses (personnel, professional services, public company operations)163164 Comparison of the three and six months ended March 31, 2023 and 2022 This section compares financial performance for the three and six months ended March 31, 2023, versus 2022, focusing on operating expenses, other income, and net loss, driven by increased R&D Operating Expenses Total operating expenses increased for both three and six months ended March 31, 2023, primarily due to higher R&D expenses from personnel, manufacturing, and trial enrollment, while G&A expenses remained consistent or slightly increased Operating Expenses | Metric | 3 Months Ended Mar 31, 2023 | 3 Months Ended Mar 31, 2022 | 6 Months Ended Mar 31, 2023 | 6 Months Ended Mar 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Total operating expenses | $14.2 million | $11.5 million | $29.6 million | $23.2 million | | Research and development expenses | $11.3 million | $8.6 million | $23.4 million | $17.3 million | | General and administrative expenses | $2.9 million | $2.9 million | $6.2 million | $6.0 million | - R&D increase (3 months): +$0.5 million personnel, +$1.0 million ANAVEX2-73 manufacturing, +$0.4 million ANAVEX3-71 manufacturing/Phase 1, increased EXCELLENCE trial enrollment costs166 - R&D increase (6 months): +$1.2 million personnel, +$1.2 million stock-based compensation, +$2.1 million manufacturing (ANAVEX2-73 & ANAVEX3-71), increased EXCELLENCE trial enrollment costs167 - G&A increase (6 months): +$0.2 million primarily due to professional and IP related costs172 Other income (net) Net other income remained consistent at $1.1 million for the three months ended March 31, 2023, but significantly increased to $3.5 million for the six-month period, primarily due to higher returns on excess cash equivalents Other Income (Net) | Metric | 3 Months Ended Mar 31, 2023 | 3 Months Ended Mar 31, 2022 | 6 Months Ended Mar 31, 2023 | 6 Months Ended Mar 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Total other income, net | $1.1 million | $1.1 million | $3.5 million | $2.0 million | - 3-month period: Increase in interest income offset by $0.96 million one-time financing expense from 2023 Purchase Agreement174 - 6-month period: Increase primarily due to higher return on excess cash invested in cash equivalents174 Net loss Net loss increased to $13.1 million ($0.17 per share) for the three months and $26.1 million ($0.33 per share) for the six months ended March 31, 2023, primarily due to higher research and development expenditures Net Loss | Metric | 3 Months Ended Mar 31, 2023 | 3 Months Ended Mar 31, 2022 | 6 Months Ended Mar 31, 2023 | 6 Months Ended Mar 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Net loss | $(13.1) million | $(10.4) million | $(26.1) million | $(21.3) million | | Net Loss per share | $(0.17) | $(0.14) | $(0.33) | $(0.28) | - Increase in net loss primarily due to increased research and development fees176 Liquidity and Capital Resources Working capital increased due to higher cash and cash equivalents from common share issuances, despite increased cash used in operations, and the company secured future funding through a new $150 million purchase agreement Working Capital Working capital increased to $145.2 million at March 31, 2023, from $142.5 million, driven by a $6.5 million rise in current assets from common share issuance, offset by cash used in operations, with current liabilities also increasing Working Capital | Metric | March 31, 2023 | September 30, 2022 | | :---------------- | :------------- | :----------------- | | Current Assets | $159,186,397 | $152,704,603 | | Current Liabilities | $14,021,343 | $10,213,561 | | Working Capital | $145,165,054 | $142,491,042 | - Increase in cash and cash equivalents of $4.3 million, mainly from $18.0 million net proceeds from common shares issuance, offset by $14.3 million cash used in operations177 - Increase in current liabilities partly due to $0.5 million deferred grant income and manufacturing/laboratory costs178 Cash Flows Net cash used in operating activities increased to $14.3 million, while net cash provided by financing activities significantly increased to $18.6 million from common share issuances, resulting in a $4.3 million overall increase in cash and cash equivalents Cash Flows | Metric | 6 Months Ended Mar 31, 2023 | 6 Months Ended Mar 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | | Net cash flows used in operating activities | $(14,282,836) | $(13,140,439) | | Net cash flows from financing activities | $18,591,937 | $14,375,250 | | Increase in cash and cash equivalents | $4,309,101 | $1,234,811 | - Increase in cash used in operating activities due to increased net loss181 - Cash provided by financing activities mainly from common shares issuance under 2023 Purchase Agreement182 Other Financings The company entered a $150 million Purchase Agreement in February 2023, issuing 2.16 million common shares for $18.2 million during the period, with $131.8 million remaining available, and no sales under the previous agreement - Entered $150 million Purchase Agreement with Lincoln Park Capital Fund, LLC on February 3, 2023, for a three-year period183 - Issued 2.16 million common shares for $18.2 million under the 2023 Purchase Agreement during the six months ended March 31, 2023187 - $131.8 million in common stock remains available for purchase under the Purchase Agreement as of March 31, 2023187 - No shares sold under the Controlled Equity Offering Sales Agreement during the six months ended March 31, 2023190 Off-Balance Sheet Arrangements The company has no material off-balance sheet arrangements that are reasonably likely to affect its financial condition, results of operations, or capital resources - No material off-balance sheet arrangements191 CRITICAL ACCOUNTING POLICIES Financial statements are prepared using U.S. GAAP, requiring estimates and assumptions, with no significant changes to critical accounting policies since the September 30, 2022, Annual Report on Form 10-K - Financial statements prepared in accordance with U.S. GAAP, requiring estimates and assumptions192 - No significant changes to critical accounting policies since the September 30, 2022, 10-K192 RECENT ACCOUNTING PRONOUNCEMENTS Readers should refer to Note 2 'Recent Accounting Pronouncements' within the Condensed Interim Consolidated Financial Statements for details on recently adopted accounting standards - Refer to Note 2 for recent accounting pronouncements193 ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS. This item is marked 'Not applicable,' indicating no material market risks requiring disclosure in this interim report - Not applicable193 ITEM 4. CONTROLS AND PROCEDURES This section confirms the effectiveness of disclosure controls and procedures as of March 31, 2023, with no material changes in internal control over financial reporting Disclosure Controls and Procedures Management, including the CEO and CFO, evaluated and concluded that the company's disclosure controls and procedures were effective as of March 31, 2023, ensuring timely and accurate reporting of material information - Disclosure controls and procedures were evaluated and deemed effective as of March 31, 2023196 - Controls designed to ensure timely and accurate reporting of material information195 Changes in Internal Control over Financial Reporting There were no material changes in the company's internal control over financial reporting during the quarter ended March 31, 2023 - No material changes to internal control over financial reporting during the quarter ended March 31, 2023197 PART II OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS The company is not aware of any material pending legal proceedings, and no directors, officers, affiliates, or major stockholders have adverse interests in any proceedings - No material pending legal proceedings198 - No adverse interests from directors, officers, affiliates, or major stockholders in any proceedings198 ITEM 1A. RISK FACTORS There have been no material changes to the risk factors previously discussed in the 'Risk Factors' section of the company's Annual Report on Form 10-K for the fiscal year ended September 30, 2022 - No material changes to risk factors since the Annual Report on Form 10-K filed November 28, 2022199 ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS During the reporting period, the company did not sell any unregistered equity securities that were not previously reported in a Current Report on Form 8-K - No unregistered sales of equity securities not previously reported199 ITEM 3. DEFAULTS UPON SENIOR SECURITIES This item is marked 'None,' indicating no defaults upon senior securities during the reporting period - None199 ITEM 4. MINE SAFETY DISCLOSURES This item is marked 'Not applicable,' indicating that mine safety disclosures are not relevant to the company's operations - Not applicable199 ITEM 5. OTHER INFORMATION This item is marked 'None,' indicating no other information to disclose that is not covered elsewhere in the report - None199 ITEM 6. EXHIBIT This section lists the exhibits filed with the Form 10-Q, including corporate documents, agreements, and various certifications, as well as XBRL documents - Lists exhibits including corporate documents, agreements, and certifications201 - Includes Registration Rights Agreement and Purchase Agreement dated February 3, 2023201 SIGNATURES The report is signed by Christopher Missling, PhD (CEO) and Sandra Boenisch (CFO), dated May 9, 2023 - Signed by Christopher Missling, PhD (CEO) and Sandra Boenisch (CFO)203204 - Signatures dated May 9, 2023204