ANAVEX LIFE SCIENCES CORP

Previous 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.

Current 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.

Previous wording

A larger Phase 2b/3 double-blind, placebo-controlled trial of ANAVEX®2-73 in Alzheimer’s disease commenced in August 2018. The Phase 2b/3 trial enrolled 509 patients, which were treated with a convenient once-daily oral formulation of ANAVEX®2-73 for 48 weeks, randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo. The trial took place at 52 sites across North America, Europe and Australia. Primary and secondary endpoints to assess safety and both cognitive and functional efficacy, were measured through the Alzheimer’s Disease Assessment Scale – Cognitive Subscale test (“ADAS-Cog”), Alzheimer’s Disease Cooperative Study – Activities of Daily Living (“ADCS-ADL”) and Clinical Dementia Rating – Sum of Boxes for cognition and function (“CDR-SB”). In addition to the primary endpoints, the ANAVEX®2-73 Phase 2b/3 trial design incorporated pre-specified statistical analyses related to potential genomic precision medicine biomarkers previously identified in the ANAVEX®2-73 Phase 2a clinical trial. The trial was completed in mid-2022 and, in December 2022, the Company presented positive topline results from the Phase 2b/3 clinical trial.

Current wording

A larger Phase 2b/3 double-blind, placebo-controlled trial of ANAVEX®2-73 in Alzheimer’s disease commenced in August 2018. The Phase 2b/3 trial enrolled 509 patients, which were treated with a convenient once-daily oral formulation of ANAVEX®2-73 for 48 weeks, randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo. The trial took place at 52 sites across North America, Europe and Australia. Primary and secondary endpoints to assess safety and both cognitive and functional efficacy, were measured through the Alzheimer’s Disease Assessment Scale – Cognitive Subscale test (“ADAS-Cog”), Alzheimer’s Disease Cooperative Study – Activities of Daily Living (“ADCS-ADL”) and Clinical Dementia Rating – Sum of Boxes for cognition and function (“CDR-SB”). In addition to these endpoints, the ANAVEX®2-73 Phase 2b/3 trial design incorporated pre-specified statistical analyses related to potential genomic precision medicine biomarkers previously identified in the ANAVEX®2-73 Phase 2a clinical trial. The trial was completed in mid-2022 and, in December 2022, the Company presented topline results from the Phase 2b/3 clinical trial. All statistical analysis were performed by outside consultancy companies.

Previous wording

Furthermore, all pre-specified clinical endpoints were further analyzed using a mixed model for repeated measures (MMRM). Under the multiplicity control rule, a trial is successful in meeting the co-primary endpoints if the significance of each endpoint is P < 0.05, or if the significance of only one co-primary endpoint is P < 0.025. If only one primary endpoint is significant at an α level of 0.025, then the secondary endpoint will be evaluated at the same level of 0.025. The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48 weeks between the ANAVEX®2-73 and placebo groups were −1.783 [95% CI, −3.314 to −0.251]; (P = 0.0226) for ADAS-Cog13, and −0.456 [95% CI, −0.831 to −0.080]; (P = 0.0175) for CDR-SB in patients with early Alzheimer’s disease.

Current wording

Furthermore, all pre-specified clinical endpoints were analyzed using a mixed model for repeated measures (MMRM). Under the multiplicity control rule, a trial is successful in meeting the co-primary endpoints if the significance of each endpoint is P < 0.05, or if the significance of only one co-primary endpoint is P < 0.025. If only one primary endpoint is significant at an α level of 0.025, then the secondary endpoint will be evaluated at the same level of 0.025. The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48 weeks between the ANAVEX®2-73 and placebo groups for ADAS-Cog13 was significant at a level of P < 0.025 and for CDR-SB was significant at a level of P < 0.025, in the patients with early Alzheimer’s disease.

Previous wording

A subsequent long-term open label extension study of ANAVEX®2-73, entitled the ATTENTION-AD trial was initiated for patients who have completed the 48-week Phase 2b/3 placebo-controlled trial referenced above. This trial extension for an additional 96 weeks is currently ongoing, and provides an opportunity to evaluate longer term safety and efficacy of ANAVEX®2-73 in persons with Alzheimer’s disease.

Current wording

A subsequent long-term open label extension study of ANAVEX®2-73, referred to as the ATTENTION-AD trial, was initiated for patients who completed the 48-week Phase 2b/3 placebo-controlled trial referenced above. This trial extension for a duration of up to 96 additional weeks was completed in June 2024. The trial will provide additional longer-term safety and efficacy data of ANAVEX®2-73 in persons with Alzheimer’s disease.

Previous wording

In February 2016, we presented positive preclinical data for ANAVEX®2-73 in Rett syndrome, a rare neurodevelopmental disease. The data demonstrated dose related and significant improvements in an array of behavioral and gait paradigms in a mouse model with an MECP2-null mutation that causes neurological symptoms that mimic Rett syndrome. The study was funded by the International Rett Syndrome Foundation (“Rettsyndrome.org”). In January 2017, we were awarded a financial grant from Rettsyndrome.org of a minimum of $0.6 million to cover some of the costs of a multicenter Phase 2 clinical trial of ANAVEX®2-73 for the treatment of Rett syndrome. This award was received in quarterly instalments which commenced during fiscal 2018.

Current wording

In February 2016, we presented positive preclinical data for ANAVEX®2-73 in Rett syndrome, a rare neurodevelopmental disease. The data demonstrated dose related significant improvements in an array of behavioral and gait paradigms in a mouse model with an MECP2-null mutation that causes neurological symptoms that mimic Rett syndrome. The study was funded by the International Rett Syndrome Foundation (“Rettsyndrome.org”). In January 2017, we were awarded a financial grant from Rettsyndrome.org of a minimum of $0.6 million to cover some of the costs of a multicenter Phase 2 clinical trial of ANAVEX®2-73 for the treatment of Rett syndrome. This award was received in quarterly instalments which commenced during fiscal 2018.

Previous wording

A high enrollment rate in the OLE of over 91% and the high level of requests for the Compassionate Use Program (93%) provide solid numerical evidence for the reported positive Real World Evidence (RWE) from patients with Rett syndrome under Compassionate Use Authorization. Families whose children were previously on drug or placebo in the placebo-controlled trial commented favorably on the improvement of their child’s daily life due to ANAVEX®2-73 treatment in the Compassionate Use Program.

Current wording

A high enrollment rate in the Open Label Extension (“OLE”) of over 91% and the high level of requests for the Compassionate Use Program (93%) provide solid numerical evidence for the reported positive Real World Evidence (RWE) from patients with Rett syndrome under Compassionate Use Authorization. Families whose children were previously on drug or placebo in the placebo-controlled trial commented favorably on the improvement of their child’s daily life due to ANAVEX®2-73 treatment in the Compassionate Use Program.

Previous wording

A 48-week Open Label Extension (“OLE”) ANAVEX2-73-PDD-EP-001 Phase 2 trial was offered to participants after completion of the double-blind placebo-controlled ANAVEX2-73-PDD-001 Phase 2 trial discussed above. The OLE trial assessed safety, tolerability and efficacy, measuring among others, MDS-Unified Parkinson’s Disease Rating Scale Parts I, II, III, REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ), Clinical Global Impression – Improvement (CGI-I), as well as cognitive efficacy endpoint Montreal Cognitive Assessment (MoCA) over a 48-week period.

Current wording

A 48-week OLE ANAVEX2-73-PDD-EP-001 Phase 2 trial was offered to participants after completion of the double-blind placebo-controlled ANAVEX2-73-PDD-001 Phase 2 trial discussed above. The OLE trial assessed safety, tolerability and efficacy, measuring among others, MDS-Unified Parkinson’s Disease Rating Scale Parts I, II, III, REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ), Clinical Global Impression – Improvement (CGI-I), as well as cognitive efficacy endpoint Montreal Cognitive Assessment (MoCA) over a 48-week period.

Previous wording

In addition, preclinical data on ANAVEX®2-73 related to multiple sclerosis indicates that ANAVEX®2-73 may promote remyelination in multiple sclerosis disease. Further, our data also demonstrates that ANAVEX®2-73 has the potential to provide protection for oligodendrocytes (“OL’s”) and oligodendrocyte precursor cells (“OPC’s”), as well as central nervous system neurons in addition to helping repair by increasing OPC proliferation and maturation in tissue culture.

Current wording

In addition, preclinical data on ANAVEX®2-73 related to multiple sclerosis indicates that ANAVEX®2-73 may promote remyelination in multiple sclerosis disease. Further, our data also demonstrates that ANAVEX®2-73 has the potential to provide protection for oligodendrocytes and oligodendrocyte precursor cells (“OPCs”), as well as central nervous system neurons in addition to helping repair by increasing OPC proliferation and maturation in tissue culture.

Previous 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.

Current wording

We hold ownership or exclusive rights to twenty-five (25) U.S. patents, twenty-five 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,” 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…

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Current wording

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 related biochemical and functional abnormalities, or loss-of-function associated with a neurodevelopmental disorder, by administering ANAVEX®2-73, ANAVEX®19-144, and/or ANAVEX®1-41 (another sigma receptor ligand similar to ANAVEX®2-73), or compositions thereof. All four patents are expected to expire in January 2037, absent any patent term extension for regulatory delays. In addition, we own one issued U.S. patent with claims directed to methods of treating melanoma with a compound related to ANAVEX®2-73. This patent is expected to expire in February 2030, absent any patent term extension for regulatory delays. We also own an issued U.S. patent that claims crystalline forms of ANAVEX®19-144, dosage forms and compositions containing the crystalline forms of ANAVEX®19-144, and methods of treatment for Alzheimer’s disease. This patent is expected to expire in July 2036, absent any patent term extension for regulatory delays. Further, we own one issued U.S. patent with claims directed to methods of treating cardiac dysfunction with ANAVEX®2-73. This patent is expected to expire in July 2038, absent any patent term extension for regulatory delays. Additionally, we own two issued U.S. patent for the treatment of insomnia, anxiety, or agitation. The first of the two patents claims methods of treating insomnia or anxiety with ANAVEX®2-73, ANAVEX®19-144, and/or ANAVEX®1-41. This patent is expected to expire in September 2038. The second of the two patents claims a dosage form comprising any of, or any combination of ANAVEX®2-73, ANAVEX®19-144, and/or ANAVEX®1-41. This patent is expected to expire in July 2038, absent any patent term extension for regulatory delays. Further, we own one issued U.S. patent with claims directed to a method of treating systolic hypertension using ANAVEX®2-73. This patent is expected to expire in July 2039, absent any patent term extension for regulatory delays. Additionally, we own one issued U.S. patent with claims directed to pharmaceutical dosage forms of (-) enantiomer of ANAVEX®2-73. This patent is expected to expire in July 2036, absent any patent term extension for regulatory delays.

Previous wording

Comparison of the three and six months ended March 31, 2024 and 2023

Current wording

Comparison of the three and nine months ended June 30, 2024 and 2023

Previous 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.

Current wording

Total operating expenses for the quarter ended June 30, 2024 were $14.7 million, compared to $13.5 million for the comparable quarter ended June 30, 2023. Total operating expenses for the nine-month period ended June 30, 2024 were $38.5 million, compared to $43.1 million for the comparable nine-month period ended June 30, 2023.

Previous wording

The decrease in research and development expenses during the three- and six-month periods is primarily related to the following;

Current wording

Our research and development expenses for the three months ended June 30, 2024 were $11.9 million, as compared to $10.3 million for the three months ended June 30, 2023. The increase in research and development expenses during the three-month period is primarily related to the following:

Previous wording

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 wording

These decreases were partially offset by (i) an increase of $1.4 million in nine-month period relating to expenditures on the ANAVEX®3-71-SZ-001 clinical trial, which trial commenced in the second quarter of fiscal 2024, (ii) an increase of $1.2 million over the comparable period relating to startup costs associated with our planned Phase 2/3 clinical trial in Parkinson’s disease, (iii) an increase of approximately $2.8 million over the comparable period relating to manufacturing activities of ANAVEX®2-73 for potential commercial use and to the support the MAA and (iv) an increase of approximately $1.2 million related to the addition of several new consultants engaged to assist in the preparation for the submission of our MAA.

Previous wording

The following table summarizes our research and development expenses for the three- and six-months ended March 31, 2024 (in thousands):

Current wording

The following table summarizes our research and development expenses for the three- and nine-months ended June 30, 2024 (in thousands):

Previous 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):

Current wording

During the three- and nine-months ended June 30, 2024 and 2023, external service providers cost by product candidate was as follows (in thousands):

Previous 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.

Current wording

General and administrative expenses were $2.9 million for the three months ended June 30, 2024, as compared to $3.2 million for the same quarter of fiscal 2023. General and administrative expenses were $8.3 million for the nine months ended June 30, 2024, as compared to $9.4 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 $0.5 million for the three month period and $1.5 million for the nine 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, 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.

Current wording

We expect to see our research and development expenditures increase from current levels as we advance our clinical programs, including advancement of ANAVEX®3-71 trial in Schizophrenia, preparation of our MAA submission to the EMA, 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 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).

Current wording

The net amount of other income for the three months ended June 30, 2024 was $2.4 million as compared to $2.3 million for the comparable three months ended June 30, 2023. The net amount of other income for the nine months ended June 30, 2024 was $7.3 million as compared to $5.8 million for the comparable nine month period ended June 30, 2023. The increase in other income for the year-to-date period is primarily related to a one-time financing charge of $0.9 million recognized in the comparable nine-month periods associated with entering into the 2023 Purchase Agreement (as described below), and an increase in interest income associated with an increase in interest rates.

Previous 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.

Current wording

Net loss for the three months ended June 30, 2024, was $12.2 million, or $0.14 per share, as compared to $11.3 million, or $0.14 per share in the comparative quarter of fiscal 2023. The net loss for the nine months ended June 30, 2024 was $31.4 million, or $0.38 per share, as compared to $37.4 million, or $0.47 per share in the comparative nine month period. The decrease in net loss for the year-to-date period is primarily related to a decrease in research and development expenditures and an increase in other income, as discussed above.

Previous 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.

Current wording

On June 30, 2024, we had net current assets of $141.5 million, a decrease of approximately $12.9 million from our year ended September 30, 2023. The decrease in net current assets primarily relates to cash utilized in operations, partially offset by $11.9 million in cash generated under the 2023 Purchase Agreement.

Previous 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.

Current wording

During the first nine months of fiscal 2024, we utilized cash and cash equivalents of $24.2 million to fund our operations, compared to $21.9 million during the same period of fiscal 2023. Our cash position was $138.8 million on June 30, 2024 compared to $151.0 million at our fiscal year ended September 30, 2023.

Previous wording

The following table summarizes cash flows during the six months ended March 31, 2024 and 2023 (in thousands):

Current wording

The following table summarizes cash flows during the nine months ended June 30, 2024 and 2023 (in thousands):

Previous 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.

Current wording

Net cash used in operating activities for the nine months ended June 30, 2024 was $24.2 million, compared to $21.9 million during the comparable period ended June 30, 2023. The principal reason for this is an increase in net cash expenses, after taking into account non-cash stock-based compensation, over the comparable period of approximately $0.7 million, as well as positive changes in other working capital accounts in the current nine-month period, as compared to the comparable nine-month period.

Previous wording

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 wording

Cash provided by financing activities for the nine-month period ended June 30, 2024 was $11.9 million, compared to $27.6 million during the comparable nine-month period ended June 30, 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.

Previous wording

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 wording

During the nine-month period ended June 30, 2024, the Company issued to Lincoln Park an aggregate of 2,455,646 shares of Common Stock under the 2023 Purchase Agreement, including 2,450,000 shares of Common Stock for an aggregate purchase price of $11.3 million and 5,646 commitment shares. During the nine-month period ended June 30, 2023, the Company issued to Lincoln Park an aggregate of 3,138,348 shares of Common Stock under the 2023 Purchase Agreement, including 3,125,000 shares of Common Stock for an aggregate purchase price of $26.7 million and 13,348 commitment shares as well as the 75,000 initial commitment shares.

Previous wording

At March 31, 2024, an amount of $114.7 million remained available under the 2023 Purchase Agreement.

Current wording

On June 30, 2024, an amount of $110.8 million remained available under the 2023 Purchase Agreement.

Previous wording

On May 1, 2020, we entered into an Amended and Restated Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. and SVB Leerink LLC (the “Sales Agents”), pursuant to which we may offer and sell shares of Common Stock registered under an effective registration statement from time to time through the Sales Agents (the “At-the-Market Offering”).

Current wording

On May 1, 2020, we entered into an Amended and Restated Sales Agreement (the “2020 Sales Agreement”) with Cantor Fitzgerald & Co. and SVB Leerink LLC (the “Sales Agents”), pursuant to which we could offer and sell shares of Common Stock registered under an effective registration statement from time to time through the Sales Agents (the “At-the-Market Offering”).

Previous wording

Upon delivery of a placement notice based on our instructions and subject to the terms and conditions of the Sales Agreement, the Sales Agents may sell shares of Common Stock by methods deemed to be an “at the market offering”, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices, or by any other method permitted by law, including negotiated transactions, subject to our prior written consent. We are not obligated to make any sales of shares under the Sales Agreement. We or the Sales Agents may suspend or terminate the At-the-Market Offering upon notice to the other party, subject to certain conditions. The Sales Agents will act as agents on a commercially reasonable efforts basis consistent with their normal trading and sales practices, applicable state and federal law, and rules and regulations and the rules of Nasdaq.

Current wording

Upon delivery of a placement notice based on our instructions and subject to the terms and conditions of the 2020 Sales Agreement, the Sales Agents could sell shares of Common Stock by methods deemed to be an “at the market offering”, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices, or by any other method permitted by law, including negotiated transactions, subject to our prior written consent. We were not obligated to make any sales of shares under the 2020 Sales Agreement. We or the Sales Agents could suspend or terminate the At-the-Market Offering upon notice to the other party, subject to certain conditions. The Sales Agents would act as agents on a commercially reasonable efforts basis consistent with their normal trading and sales practices, applicable state and federal law, and rules and regulations and the rules of Nasdaq.

Previous wording

We have agreed to pay the Sales Agents’ commissions for their services of 3.0% of the gross proceeds from the sale of shares of Common Stock pursuant to the Sales Agreement. We have also agreed to provide the Sales Agents with customary indemnification and contribution rights.

Current wording

We agreed to pay the Sales Agents’ commissions for their services of 3.0% of the gross proceeds from the sale of shares of Common Stock pursuant to the 2020 Sales Agreement. We also agreed to provide the Sales Agents with customary indemnification and contribution rights.

Previous 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.

Current wording

No shares were sold during the nine months ended June 30, 2024 and 2023 under the 2020 Sales Agreement. The Company terminated the 2020 Sales Agreement on July 24, 2024.