ANAVEX LIFE SCIENCES CORP
For the period ended Mar 31, 2024. Filed May 9, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2024 · Filed May 9, 2024
AVXL$1.15+3.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2023-12-31; filed 2024-02-07.
0001731122-24-000206
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-Q
Period ended 2024-03-31; filed 2024-05-09.
0001731122-24-000760
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 152 previous paragraphs and 158 current paragraphs.
123 unchanged; 26 reworded; 7 added; 3 removed; 0 previous and 2 current paragraphs rearranged.
Tables are not compared: 19 previous and 19 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (7)
Current report
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
Current report
Schizophrenia
Current report
The decrease in research and development expenses during the three- and six-month periods is primarily related to the following;
Current report
These decreases were partially offset by an increase of $0.5 million in both the three- and six-month periods relating to expenditures on the ANAVEX®3-71-SZ-001 clinical trial, which trial commenced in the current period.
Current report
Cash provided by financing activities for the six-month period ended March 31, 2024 was $7.3 million, compared to $18.6 million during the comparable six-month period ended March 31, 2023. Cash provided by financing activities in both periods is primarily attributable to cash received from the issuance of common shares at various market prices under the 2023 Purchase Agreement.
Current report
During the six-month period ended March 31, 2024, the Company issued to Lincoln Park an aggregate of 1,503,707 shares of Common Stock under the 2023 Purchase Agreement, including 1,500,000 shares of Common Stock for an aggregate purchase price of $7,411,700 and 3,707 commitment shares. During the six-month period ended March 31, 2023, the Company issued to Lincoln Park an aggregate of 2,159,080 shares of Common Stock under the 2023 Purchase Agreement, including 2,075,000 shares of Common Stock for an aggregate purchase price of $18,152,000, 9,080 commitment shares as well as the 75,000 initial commitment shares.
Current report
At March 31, 2024, an amount of $114.7 million remained available under the 2023 Purchase Agreement.
Removed paragraphs (3)
Previous report
Cash provided by financing activities for the three months ended December 31, 2023 was $0.06 million, from the exercise of stock options during the period. Cash provided by financing activities for the three months ended December 31, 2022 was$0.3 million, also attributable to the exercise of stock options during that period. The Company did not sell any shares under the 2023 Purchase Agreement or Sales Agreement, both described below, during either of the periods.
Previous report
During the three months ended December 31, 2023 and 2022, the Company did not issue any shares of Common Stock to Lincoln Park under the 2023 Purchase Agreement.
Previous report
As of December 31, 2023, an amount of $122.1 million in shares of our Common Stock remains available for purchase by Lincoln Park under the 2023 Purchase Agreement.
Reworded paragraphs (26)
Previous wording
Many diseases are possibly directly caused by chronic homeostatic imbalances or cellular stress of brain cells. In pediatric diseases, such as Rett syndrome or infantile spasms, the chronic cellular stress is possibly caused by the presence of a constant genetic mutation. In neurodegenerative diseases, such as Alzheimer’s and Parkinson’s diseases, chronic cellular stress is possibly caused by age-correlated buildup of cellular insult and hence chronic cellular stress. Specifically, defects in homeostasis of protein or ribonucleic acid (“RNA”) lead to the death of neurons and dysfunction of the nervous system. The spreading of protein aggregates resulting in a proteinopathy, a characteristic found in Alzheimer’s and Parkinson’s diseases that results from disorders of protein synthesis, trafficking, folding, processing or degradation in cells. The clearance of macromolecules in the brain is particularly susceptible to imbalances that result in aggregation and degeneration in nerve cells. For example, Alzheimer’s disease pathology is characterized by the presence of amyloid plaques, and neurofibrillary tangles, which are aggregates of hyperphosphorylated Tau protein that are a marker of other diseases known as tauopathies as well as inflammation of microglia. With the SIGMAR1 activation through SIGMAR1 agonists like ANAVEX®2-73 (blarcamesine), our approach is to restore cellular balance (i.e. homeostasis). Therapies that correct defects in cellular homeostasis might have the potential to halt or delay neurodevelopmental and neurodegenerative disease progression.
Current wording
Many diseases are possibly directly caused by chronic homeostatic imbalances or cellular stress of brain cells. In pediatric diseases, such as Rett syndrome or infantile spasms, chronic cellular stress is possibly caused by the presence of a constant genetic mutation. In neurodegenerative diseases, such as Alzheimer’s and Parkinson’s diseases, chronic cellular stress is possibly caused by age-correlated buildup of cellular insult and hence chronic cellular stress. Specifically, defects in homeostasis of protein or ribonucleic acid (“RNA”) lead to the death of neurons and dysfunction of the nervous system. The spreading of protein aggregates resulting in a proteinopathy, a characteristic found in Alzheimer’s and Parkinson’s diseases that results from disorders of protein synthesis, trafficking, folding, processing or degradation in cells. The clearance of macromolecules in the brain is particularly susceptible to imbalances that result in aggregation and degeneration in nerve cells. For example, Alzheimer’s disease pathology is characterized by the presence of amyloid plaques, and neurofibrillary tangles, which are aggregates of hyperphosphorylated Tau protein that are a marker of other diseases known as tauopathies as well as inflammation of microglia. With the SIGMAR1 activation through SIGMAR1 agonists like ANAVEX®2-73 (blarcamesine), our approach is to restore cellular balance (i.e. homeostasis). Therapies that correct defects in cellular homeostasis might have the potential to halt or delay neurodevelopmental and neurodegenerative disease progression.
Previous wording
As part of some of our clinical trials, we have incorporated a genomic analysis to better understand potential populations for whom our clinical programs might benefit. In our clinical trials, a full genomic analysis of Alzheimer’s disease patients treated with ANAVEX®2-73 (blarcamesine) has helped us identify actionable genetic variants. A significant impact of the genomic biomarkers SIGMAR1, the direct target of ANAVEX®2-73 (blarcamesine) and COMT, a gene involved in memory function, on the drug response level was identified, leading to an early ANAVEX®2-73 (blarcamesine) specific biomarker hypothesis. We believe thatexcluding patients with SIGMAR1 identified biomarker variant (approximately 10%-20% of the population) in prospective studies would identify approximately 80%-90% patients that would display clinically significant improved functional and cognitive scores. The consistency between the identified DNA and RNA data related to ANAVEX®2-73 (blarcamesine), which are considered independent of Alzheimer’s disease pathology, as well as multiple endpoints and time-points, provides support for the potential precision medicine clinical development of ANAVEX®2-73 (blarcamesine) by using genetic biomarkers identified within the trial population itself to either confirm the mechanism of action of ANAVEX®2-73 (blarcamesine) or target patients who are most likely to respond to ANAVEX®2-73 (blarcamesine) treatment. We may in the future utilize such an approach in Alzheimer’s disease as well as indications like Parkinson’s disease dementia or Rett syndrome in which ANAVEX®2-73 (blarcamesine) is currently being studied.
Current wording
a gene involved in memory function, on the drug response level was identified, leading to an early ANAVEX®2-73 (blarcamesine) specific biomarker hypothesis. We believe thatexcluding patients with SIGMAR1 identified biomarker variant (approximately 10%-20% of the population) in prospective studies would identify approximately 80%-90% patients that would display clinically significant improved functional and cognitive scores. The consistency between the identified DNA and RNA data related to ANAVEX®2-73 (blarcamesine), which are considered independent of Alzheimer’s disease pathology, as well as multiple endpoints and time-points, provides support for the potential precision medicine clinical development of ANAVEX®2-73 (blarcamesine) by using genetic biomarkers identified within the trial population itself to either confirm the mechanism of action of ANAVEX®2-73 (blarcamesine) or target patients who are most likely to respond to ANAVEX®2-73 (blarcamesine) treatment. We may in the future utilize such an approach in Alzheimer’s disease as well as indications like Parkinson’s disease dementia or Rett syndrome in which ANAVEX®2-73 (blarcamesine) is currently being studied.
Previous wording
ANAVEX®2-73 met the co-primary endpoints ADAS-Cog and ADCS-ADL and key secondary endpoint CDR-SB. ANAVEX®2-73 treatment slowed decline of cognition and function in patients with early Alzheimer’s disease over 48 weeks. Patients treated with ANAVEX®2-73 had 1.84 times higher odds, or likelihood, to improve cognitively compared to placebo, with a ADAS-Cog score threshold change of -0.5 points or better [Odds Ratio = 1.84 (p = 0.015)]. At clinically significant levels of improvement in function (ADCS-ADL score threshold change of +3.5 points or better), patients treated with ANAVEX®2-73 had 2.67 times higher odds, or likelihood, to improve function compared to placebo [Odds Ratio = 2.67 (p = 0.0255)]. Additionally, treatment with ANAVEX®2-73 reduced cognitive decline at end of treatment, measured with the ADAS-Cog, as compared to placebo, by 45%, representing a treatment difference in mean score change of -1.85 points (p=0.033). Compared to placebo, ANAVEX®2-73 reduced clinical decline of cognition and function by 27% with mean score difference of -0.42 points (p=0.040) as measured by the CDR-SB. ANAVEX®2-73 was generally safe and well tolerated. All statistical analyses were performed by outside consultancy companies.
Current wording
ANAVEX®2-73 met the co-primary endpoints ADAS-Cog and ADCS-ADL and key secondary endpoint CDR-SB. ANAVEX®2-73 treatment slowed decline of cognition and function in patients with early Alzheimer’s disease over 48 weeks. In addition, patients treated with ANAVEX®2-73 had 1.84 times higher odds, or likelihood, to improve cognitively compared to placebo, with an ADAS-Cog score threshold change of -0.5 points or better [Odds Ratio = 1.84 (p = 0.015)]. At clinically significant levels of improvement in function (ADCS-ADL score threshold change of +3.5 points or better), patients treated with ANAVEX®2-73 had 2.67 times higher odds, or likelihood, to improve function compared to placebo [Odds Ratio = 2.67 (p = 0.0255)]. Additionally, treatment with ANAVEX®2-73 reduced cognitive decline at end of treatment, measured with the ADAS-Cog, as compared to placebo, by 45%, representing a treatment difference in mean score change of -1.85 points (p=0.033). Compared to placebo, ANAVEX®2-73 reduced clinical decline of cognition and function by 27% with mean score difference of -0.42 points (p=0.040) as measured by the CDR-SB. ANAVEX®2-73 was generally safe and well tolerated. All statistical analyses were performed by outside consultancy companies.
Previous wording
The next study with ANAVEX®3-71 is the U.S. FDA cleared placebo-controlled Phase 2 ANAVEX®3-71-SZ-001 study, will consist of two parts to explore multiple ascending doses in individuals with schizophrenia followed bya 28-day treatment period in a larger cohort. The study will utilize standard clinical outcome measures for schizophrenia including the Positive and Negative Symptoms Scale (PANSS) and novel electrophysiological biomarkers identified by the ERP Biomarker Qualification Consortium for use in schizophrenia clinical trials.
Current wording
In March 2024, we commenced the U.S. FDA cleared ANAVEX®3-71-SZ-001 clinical trial, a double-blind, placebo-controlled Phase 2 trial in schizophrenia. The trial consists of two parts to explore multiple ascending doses in individuals with schizophrenia followed by a 28-day treatment period in a larger cohort. The trial will utilize standard clinical outcome measures for schizophrenia including the Positive and Negative Symptoms Scale (PANSS), and novel fluid and electrophysiological biomarkers will also be assessed, leveraging several advances in electroencephalography/event-related potential (EEG/ERP) biomarkers in schizophrenia developed in collaboration with the industry-led ERP Biomarker Qualification Consortium. In addition to the electrophysiological biomarkers, we are also applying novel neuroinflammatory, metabolomic, and transcriptomic biomarkers at the intersection of schizophrenia pathophysiology and ANAVEX®3-71’s novel, dual mechanism of action.
Previous wording
In May 2016 and June 2016, the FDA granted Orphan Drug Designation to ANAVEX®2-73 for the treatment of Rett syndrome and infantile spasms, respectively. In November 2019, the FDA granted to ANAVEX®2-73 the Rare Pediatric Disease (RPD) designation for the treatment of Rett syndrome. The RPD designation is intended to encourage the development of treatments for rare pediatric diseases.
Current wording
In May 2016 and June 2016, the FDA granted Orphan Drug Designation to ANAVEX®2-73 for the treatment of Rett syndrome and infantile spasms, respectively. In November 2019, the FDA granted ANAVEX®2-73 the Rare Pediatric Disease (RPD) designation for the treatment of Rett syndrome. The RPD designation is intended to encourage the development of treatments for rare pediatric diseases.
Previous wording
We hold ownership or exclusive rights to twenty-four (24) U.S. patents, twenty-three U.S. patent applications, and various PCT or ex-U.S. patent applications relating to our drug candidates, methods associated therewith, and to our research programs.
Current wording
We hold ownership or exclusive rights to twenty-five (25) U.S. patents, twenty-four U.S. patent applications, and various PCT or ex-U.S. patent applications relating to our drug candidates, methods associated therewith, and to our research programs.
Previous wording
We own one issued U.S. patent entitled “ANAVEX®2-73 and certain anticholinesterase inhibitors composition and method for neuroprotection” claims a composition of matter of ANAVEX®2-73 directed to a novel and synergistic neuroprotective compound combined with donepezil and other cholinesterase inhibitors. This patent is expected to expire in June 2034, absent any patent term extension for regulatory delays. We own one issued U.S. patent entitled “A2-73 crystalline polymorph compositions of matter and methods of use thereof”. It claims crystals of A2-73 freebase or its fumarate salt, dosage forms and pharmaceutical formulations. This patent is expected to expire in July 2039, absent any patent term extension for regulatory delays. We own four issued U.S. patents each with claims directed to crystalline forms of ANAVEX®2-73. The first of these four patents claims crystalline forms of ANAVEX®2-73, dosage forms and compositions containing crystalline ANAVEX®2-73, and methods of treatment for Alzheimer’s disease using them. This patent is expected to expire in July 2036, absent any patent term extension for regulatory delays. The second of these four patents claims pharmaceutical compositions containing a crystalline form of ANAVEX®2-73, and methods of treatment for Alzheimer’s disease using the compositions. This patent is expected to expire in June 2036, absent any patent term extension for regulatory delays. The third of these four patents claims pharmaceutical compositions containing a crystalline form of ANAVEX®2-73, and methods of treatment for Alzheimer’s disease using the compositions. This patent is expected to expire in June 2036, absent any patent term extension for regulatory delays. The fourth of these four patents claims method of making certain crystalline forms ANAVEX®2-73. This patent is expected to expire in October 2036, absent any patent term extension for regulatory delays. We also own three issued U.S. patents for seizure treatment. The first of these three patents claims methods and dosage forms for treating seizures, the dosage forms containing a low-dose anti-epilepsy drug combined with either: (i) ANAVEX®2-73 and its active metabolite ANAVEX®19-144; or (ii) ANAVEX®19-144. The second of these three patents further claims a combination seizure treatment involving administration of an anti-epilepsy drug combined with (i) ANAVEX®19-144, or (ii) ANAVEX 19-144® and ANAVEX 2-73®. The third of these three patents claims a dosage form for seizure reduction, comprising (i) ANAVEX®19-144, (ii) ANAVEX®2-73, or (iii) a combination of ANAVEX®19-144 and ANAVEX®2-73; and optionally further comprising a low-dose anti-epilepsy drug. All three patents are expected to expire in October 2035, absent any patent term extension for regulatory delays. We also own four issued U.S. patents with claims directed to treating neurodevelopmental disorders. These patents claim methods for treating a neurodevelopmental disorder, multiple sclerosis, their relat…
Excerpt shortened here; the source contains the full paragraph.
Current wording
We own one issued U.S. patent entitled “ANAVEX®2-73 and certain anticholinesterase inhibitors composition and method for neuroprotection,” which claims a composition of matter of ANAVEX®2-73 directed to a novel and synergistic neuroprotective compound combined with donepezil and other cholinesterase inhibitors. This patent is expected to expire in June 2034, absent any patent term extension for regulatory delays. We own one issued U.S. patent entitled “A2-73 crystalline polymorph compositions of matter and methods of use thereof”. It claims crystals of A2-73 freebase or its fumarate salt, dosage forms and pharmaceutical formulations. This patent is expected to expire in July 2039, absent any patent term extension for regulatory delays. We own four issued U.S. patents each with claims directed to crystalline forms of ANAVEX®2-73. The first of these four patents claims crystalline forms of ANAVEX®2-73, dosage forms and compositions containing crystalline ANAVEX®2-73, and methods of treatment for Alzheimer’s disease using them. This patent is expected to expire in July 2036, absent any patent term extension for regulatory delays. The second of these four patents claims pharmaceutical compositions containing a crystalline form of ANAVEX®2-73, and methods of treatment for Alzheimer’s disease using the compositions. This patent is expected to expire in June 2036, absent any patent term extension for regulatory delays. The third of these four patents claims pharmaceutical compositions containing a crystalline form of ANAVEX®2-73, and methods of treatment for Alzheimer’s disease using the compositions. This patent is expected to expire in June 2036, absent any patent term extension for regulatory delays. The fourth of these four patents claims method of making certain crystalline forms ANAVEX®2-73. This patent is expected to expire in October 2036, absent any patent term extension for regulatory delays. We also own three issued U.S. patents for seizure treatment. The first of these three patents claims methods and dosage forms for treating seizures, the dosage forms containing a low-dose anti-epilepsy drug combined with either: (i) ANAVEX®2-73 and its active metabolite ANAVEX®19-144; or (ii) ANAVEX®19-144. The second of these three patents further claims a combination seizure treatment involving administration of an anti-epilepsy drug combined with (i) ANAVEX®19-144, or (ii) ANAVEX 19-144® and ANAVEX 2-73®. The third of these three patents claims a dosage form for seizure reduction, comprising (i) ANAVEX®19-144, (ii) ANAVEX®2-73, or (iii) a combination of ANAVEX®19-144 and ANAVEX®2-73; and optionally further comprising a low-dose anti-epilepsy drug. All three patents are expected to expire in October 2035, absent any patent term extension for regulatory delays. We also own four issued U.S. patents with claims directed to treating neurodevelopmental disorders. These patents claim methods for treating a neurodevelopmental disorder, multiple sclerosis, thei…
Excerpt shortened here; the source contains the full paragraph.
Previous wording
We also own two issued U.S. patents related to ANAVEX®1066. The first of these two patents claims methods for treating or preventing pain using (+) ANAVEX®1066 isomer. The second patent claims methods for treating or preventing pain using (-) ANAVEX®1066 isomer. Both patents are expected to expire in November 2036, absent any patent term extension for regulatory delays.
Current wording
We also own three (3) issued U.S. patents related to ANAVEX®1066. The first of these two patents claims methods for treating or preventing pain using (+) ANAVEX®1066 isomer. The second patent claims methods for treating or preventing pain using (-) ANAVEX®1066 isomer. The third patent claims dosage forms and pharmaceutical compositions comprising (+) ANAVEX®1066 isomer. All three patents are expected to expire in November 2036, absent any patent term extension for regulatory delays.
Previous wording
We also own other patent applications directed to enantiomers, crystals, formulations, uses, and patient selection methods that may provide additional protection for one or more of our product candidates.
Current wording
We also own other patent applications and certain granted foreign patents directed to enantiomers, crystals, formulations, uses, and patient selection methods that may provide additional protection for one or more of our product candidates.
Previous wording
Comparison of the three months ended December 31, 2023 and 2022
Current wording
Comparison of the three and six months ended March 31, 2024 and 2023
Previous wording
Total operating expenses for the quarter ended December 31, 2023 were $11.3 million, compared to $15.4 million for the comparable quarter ended December 31, 2022.
Current wording
Total operating expenses for the quarter ended March 31, 2024 were $12.5 million, compared to $14.2 million for the comparable quarter ended March 31, 2023. Total operating expenses for the six-month period ended March 31, 2024 were $23.8 million, compared to $29.6 million for the comparable six month period ended March 31, 2023.
Previous wording
Our research and development expenses for the three months ended December 31, 2023 were $8.7 million, as compared to $12.1 million for the three months ended December 31, 2022. The decrease in research and development expenses is primarily related to the following;
Current wording
Our research and development expenses for the three months ended March 31, 2024 were $9.7 million, as compared to $11.3 million for the three months ended March 31 2023. Our research and development expenses for the six months ended March 31, 2024 were $18.4 million, as compared to $23.4 million for the comparable six month period ended March 31 2023.
Previous wording
The following table summarizes our research and development expenses for the three months ended December 31, 2023 and 2022 (in thousands):
Current wording
The following table summarizes our research and development expenses for the three- and six-months ended March 31, 2024 (in thousands):
Previous wording
During the three months ended December 31, 2023 and 2022, external service providers cost by product candidate was as follows (in thousands):
Current wording
During the three- and six-months ended March 31, 2024 and 2023, external service providers cost by product candidate was as follows (in thousands):
Previous wording
General and administrative expenses were $2.6 million for the three months ended December 31, 2023, as compared to $3.3 million for the same quarter of fiscal 2022. The primary reason for the decrease in general and administrative expenses was a reduction in stock-based compensation charges of $0.8 million as a result of the vesting of previously awards stock options and the extended timeline of milestone based vesting awards.
Current wording
General and administrative expenses were $2.8 million for the three months ended March 31, 2024, as compared to $2.9 million for the same quarter of fiscal 2023. General and administrative expenses were $5.4 million for the six months ended March 31, 2024, as compared to $6.2 million for the same period of fiscal 2023.The primary reason for the decrease in general and administrative expenses was a reduction in stock-based compensation charges of $0.3 million for the three month period and $1.1 million for the six month period, as a result of the vesting of previous option awards and the extended timeline of milestone based vesting awards.
Previous wording
We expect to see our research and development expenditures increase from current levels as we advance our clinical programs, including ongoing extension trials of our Alzheimer’s and Rett syndrome programs, planned initiation of an ANAVEX®3-71 trial in Schizophrenia, planned advancement of ANAVEX®2-73 for Parkinson’s disease, planned initiation of an ANAVEX®2-73 for Fragile X clinical trial, and as we continue to add additional staffing to manage and support these clinical initiatives.
Current wording
We expect to see our research and development expenditures increase from current levels as we advance our clinical programs, including ongoing extension trials of our Alzheimer’s and Rett syndrome programs, advancement of ANAVEX®3-71 trial in Schizophrenia, planned advancement of ANAVEX®2-73 for Parkinson’s disease, planned initiation of an ANAVEX®2-73 for a Fragile X clinical trial, and as we continue to add additional staffing to manage and support these clinical initiatives.
Previous wording
The net amount of other income for the three months ended December 31, 2023 was $2.8 million as compared to $2.4 million for the comparable three months ended December 31, 2022. The increase in other income for the quarter is primarily related to an increase in return on excess cash invested in cash equivalents due to a marketwide increase in interest rates.
Current wording
The net amount of other income for the three months ended March 31, 2024 was $2.1 million as compared to $1.1 million for the comparable three months ended March 31, 2023. The net amount of other income for the six months ended March 31, 2024 was $4.8 million as compared to $3.5 million for the comparable six month period ended March 31, 2023. The increase in other income for the quarter is primarily related to a one-time financing charge of $0.9 million recognized in the comparable three- and six-month periods associated with entering into the 2023 Purchase Agreement (as described below).
Previous wording
Net loss for the three months ended December 31, 2023, was $8.6 million, or $0.11 per share, as compared to $13.0 million, or $0.17 per share in the comparative quarter of fiscal 2023. The decrease in net loss for the quarter is primarily related to a decrease in research and development expenditures and an increase in other income, as discussed above.
Current wording
Net loss for the three months ended March 31, 2024, was $10.5 million, or $0.13 per share, as compared to $13.1 million, or $0.17 per share in the comparative quarter of fiscal 2023. The net loss for the six months ended March 31, 2024 was $19.2 million, or $0.23 per share, as compared to $26.1 million, or $0.33 per share in the comparative six month period. The decrease in net loss for the quarter is primarily related to a decrease in research and development expenditures and an increase in other income, as discussed above.
Previous wording
At December 31, 2023, we had net current assets of $135.6 million, a decrease of $6.3 million from September 30, 2023. The decrease in net current assets primarily relates to a decrease in cash and cash equivalents of $7.3 million due to cash utilized in operations, which were funded using cash and cash equivalents on hand.
Current wording
At March 31, 2024, we had net current assets of $144.5 million, a decrease of $10.0 million from September 30, 2023. The decrease in net current assets primarily relates to a decrease in cash and cash equivalents of $11.6 million due to cash utilized in operations, partially offset by $7.2 million in cash generated under the 2023 Purchase Agreement. Over the period, our net working capital position decreased by $6.9 million to $135.0 million.
Previous wording
During the first three months of fiscal 2023, we utilized cash and cash equivalents of $7.3 million to fund our operations, compared to $5.8 million during the same period of fiscal 2022. Our cash position was $143.8 million at December 31, 2023 compared to $151.0 million at our fiscal year ended September 30, 2023.
Current wording
During the first six months of fiscal 2024, we utilized cash and cash equivalents of $19.0 million to fund our operations, compared to $14.3 million during the same period of fiscal 2023. Our cash position was $139.4 million at March 31, 2024 compared to $151.0 million at our fiscal year ended September 30, 2023.
Previous wording
The following table summarizes cash flows during the three months ended December 31, 2023 and 2022 (in thousands):
Current wording
The following table summarizes cash flows during the six months ended March 31, 2024 and 2023 (in thousands):
Previous wording
Net cash used in operating activities for the three months ended December 31, 2023 was $7.3 million, compared to $5.8 million during the comparable period ended December 31, 2022. The principal reason for this increase in net cash used in operating activities in the current period is due to a net increase in accounts payable and accrued liabilities in the comparable quarter.
Current wording
Net cash used in operating activities for the six months ended March 31, 2024 was $19.0 million, compared to $14.3 million during the comparable period ended March 31, 2023. The principal reason for this increase in net cash used in operating activities in the current period is due to a net decrease (pay down) of $3.0 million in accounts payable and accrued liabilities during the six-month period ended March 31, 2024, as compared to a net increase of $3.3 million in accounts payable and accrued liabilities in the comparable six-month period.
Previous wording
On any business day and subject to certain customary conditions, the Company may direct Lincoln Park to purchase up to 200,000 shares of Common Stock (such purchases, “Regular Purchases”). The amount of a Regular Purchase may increase under certain circumstances based on the market price of the Common Stock; provided, however, that Lincoln Park’s committed obligation under any Regular Purchase shall not exceed $4.0 million. The purchase price of shares of Common Stock will be based on the then prevailing market prices of such shares at the time of sales as described in the Purchase Agreement. There are no limits on the price per share that Lincoln Park may pay to purchase Common Stock under the Purchase Agreement. In addition, if the Company has directed Lincoln Park to purchase the full amount of Common Stock available as a Regular Purchase on a given day, it may direct Lincoln Park to purchase additional amounts as “accelerated purchases” and “additional accelerated purchases,” each as set forth in the Purchase Agreement.
Current wording
On any business day and subject to certain customary conditions, the Company may direct Lincoln Park to purchase up to 200,000 shares of Common Stock (such purchases, “Regular Purchases”). The amount of a Regular Purchase may increase under certain circumstances based on the market price of the Common Stock; provided, however, that Lincoln Park’s committed obligation under any Regular Purchase shall not exceed $4.0 million. The purchase price of shares of Common Stock will be based on the then prevailing market prices of such shares at the time of sales as described in the 2023 Purchase Agreement. There are no limits on the price per share that Lincoln Park may pay to purchase Common Stock under the 2023 Purchase Agreement. In addition, if the Company has directed Lincoln Park to purchase the full amount of Common Stock available as a Regular Purchase on a given day, it may direct Lincoln Park to purchase additional amounts as “accelerated purchases” and “additional accelerated purchases,” each as set forth in the 2023 Purchase Agreement.
Previous wording
The Purchase Agreement limits the Company’s sale of shares of Common Stock to Lincoln Park to 15,606,426 shares of Common Stock, representing 19.99% of the shares of the Common Stock outstanding on the date of the Purchase Agreement unless (i) stockholder approval is obtained to issue more than such amount or (ii) the average price of all applicable sales of Common Stock to Lincoln Park under the Purchase Agreement equals or exceeds the lower of (A) the closing price of the Common Stock on the Nasdaq Capital Market immediately preceding the Execution Date or (B) the average of the closing price of the Common Stock on the Nasdaq Capital Market for the five Business Days immediately preceding the Execution Date.
Current wording
The 2023 Purchase Agreement limits the Company’s sale of shares of Common Stock to Lincoln Park to 15,606,426 shares of Common Stock, representing 19.99% of the shares of the Common Stock outstanding on the date of the 2023 Purchase Agreement unless (i) stockholder approval is obtained to issue more than such amount or (ii) the average price of all applicable sales of Common Stock to Lincoln Park under the 2023 Purchase Agreement equals or exceeds the lower of (A) the closing price of the Common Stock on the Nasdaq Capital Market immediately preceding the Execution Date or (B) the average of the closing price of the Common Stock on the Nasdaq Capital Market for the five Business Days immediately preceding the Execution Date.
Previous wording
The Purchase Agreement also prohibits the Company from directing Lincoln Park to purchase any shares of Common Stock if those shares, when aggregated with all other shares of Common Stock then beneficially owned by Lincoln Park and its affiliates, would result in Lincoln Park and its affiliates having beneficial ownership, at any single point in time, of more than 4.99% of the then total outstanding shares of Common Stock, as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder.
Current wording
The 2023 Purchase Agreement also prohibits the Company from directing Lincoln Park to purchase any shares of Common Stock if those shares, when aggregated with all other shares of Common Stock then beneficially owned by Lincoln Park and its affiliates, would result in Lincoln Park and its affiliates having beneficial ownership, at any single point in time, of more than 4.99% of the then total outstanding shares of Common Stock, as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder.
Previous wording
No shares were sold during the three months ended December 31, 2023 and 2022 under the Sales Agreement. The Company currently is unable to sell shares of common stock under the Sales Agreement.
Current wording
No shares were sold during the six months ended March 31, 2024 and 2023 under the Sales Agreement. The Company currently is unable to sell shares of Common Stock under the Sales Agreement.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
As part of some of our clinical trials, we have incorporated a genomic analysis to better understand potential populations for whom our clinical programs might benefit. In our clinical trials, a full genomic analysis of Alzheimer’s disease patients treated with ANAVEX®2-73 (blarcamesine) has helped us identify actionable genetic variants. A significant impact of the genomic biomarkers SIGMAR1, the direct target of ANAVEX®2-73 (blarcamesine) and COMT,
Current report — wording carried from elsewhere
The first of these trials, the ANAVEX®3-71-SZ-001 clinical trial, commenced in March 2024 and is more fully described above underClinical Trials Overview – Schizophrenia.