Core Insights - Acasti Pharma Inc. is advancing GTX-104, a novel injectable formulation of nimodipine, targeting aneurysmal subarachnoid hemorrhage (aSAH) with a potential NDA submission to the FDA anticipated in the first half of calendar 2025 [1][2][3] Financial Performance - For the fiscal year ended March 31, 2024, Acasti reported a net loss of $12.9 million, or $1.35 loss per share, a significant decrease from a net loss of $42.4 million, or $5.71 per share, for the previous year [4][24] - Research and development expenses were $4.7 million, down from $10.0 million in the prior year, primarily due to strategic realignment efforts [5] - General and administrative expenses decreased to $6.4 million from $7.6 million, attributed to reduced headcount and restructuring costs [5] Cash Position - As of March 31, 2024, the company had cash and cash equivalents of $23.0 million, down from $27.9 million a year earlier, with a projected cash runway extending into the second calendar quarter of 2026 [6][2] Clinical Development - The STRIVE-ON trial, a pivotal Phase 3 safety trial for GTX-104, is progressing well, with steady patient enrollment since its initiation in October 2023 [2][3] - Acasti hosted a Key Opinion Leader event in October 2023 to discuss GTX-104 as a potential new treatment standard for aSAH [3] Market Opportunity - The addressable market for GTX-104 in the United States is estimated to be approximately $300 million, based on market research [9] - Aneurysmal subarachnoid hemorrhage affects around 50,000 patients annually in the U.S., with significant mortality and dependency rates [7]

Financial Position - As of March 31, 2024, the company reported cash and cash equivalents of $23.0 million and intangible assets and goodwill of $49.3 million[282]. - Cash and cash equivalents as of March 31, 2024, were $23.0 million, a decrease of $4.9 million from $27.9 million in 2023[306]. - The company has $6.0 million in commitments for contract research organizations (CROs) for the next twelve months as of March 31, 2024[314]. - The company maintains cash and cash equivalents at accredited financial institutions, exceeding federally insured limits, to manage credit risk[331]. - Interest rate risk exposure as of March 31, 2024, is limited due to short-term investments held to maturity[332]. Financial Performance - The net loss for the year ended March 31, 2024, was $12.9 million, a decrease of $29.6 million from the net loss of $42.4 million for the year ended March 31, 2023[286]. - Net cash used in operating activities improved to $12.3 million in 2024 from $15.9 million in 2023, a reduction of $3.6 million[306]. - Investing activities generated cash of $104 thousand in 2024, a significant decrease from $13.2 million in 2023[307]. - Net cash provided by financing activities was $7.4 million in 2024, primarily from a September 2023 offering, compared to $304 thousand in 2023[308]. - The company completed a private placement on September 24, 2023, raising approximately $7.3 million by selling 1,951,371 Class A common shares at $1.848 each[309][311]. Expenses - Research and development expenses for the year ended March 31, 2024, totaled $4.7 million, down from $10.0 million in the previous year, primarily due to a focus on the GTX-104 drug candidate[284][289]. - General and administrative expenses decreased to $6.4 million for the year ended March 31, 2024, from $7.6 million in the prior year, mainly due to a reduction in headcount[294]. - Sales and marketing expenses were $252 thousand for the year ended March 31, 2024, down from $661 thousand in the previous year, reflecting a reduction in headcount[296][297]. - The company incurred $1.5 million in restructuring costs related to workforce reductions aimed at prioritizing resources for GTX-104[298]. Impairment and Valuation - An impairment of intangible assets of $28.7 million was recorded for the year ended March 31, 2023, compared to none for the year ended March 31, 2024[301]. - The impairment of intangible assets recorded for the year ended March 31, 2023, was $28.7 million, resulting in a recovery of $8.6 million of the related deferred tax liability[323]. - The estimated fair values of intangible assets are based on significant assumptions, including the probability of clinical success and projected net sales[324]. - The projected discounted cash flow model indicates that an impairment loss for GTX-101, GTX-102, and GTX-104 would occur if net sales assumptions decrease by more than approximately 32.3%, 21.0%, and 50.7% respectively[326]. - Changes in forecasted cash flows and selected discount rates could materially affect the estimation of fair value and result in impairment charges in future quarters[328]. Future Outlook - The company plans to defer further development of GTX-102 and GTX-101 until additional funding or strategic partnerships are secured[299]. - The company does not expect to generate revenue from product sales until drug development is successfully completed and regulatory approval is obtained, which is anticipated to take several years[334]. - The company expects to have sufficient cash resources to meet objectives into the second calendar quarter of 2026, requiring additional capital to fund operations beyond that time[335]. - The company has incurred operating losses and negative cash flows from operations since inception, expecting significant expenses and continued losses for the foreseeable future[333]. Internal Controls - Management has concluded that internal controls over financial reporting were effective as of March 31, 2024, based on an assessment using COSO criteria[338]. - No changes were made to internal controls over financial reporting during the three months ended March 31, 2024, that materially affected their effectiveness[339]. Interest Income - Interest income increased to $911 thousand for the year ended March 31, 2024, compared to $246 thousand in the previous year, due to higher interest rates on cash balances[304]. Derivative Liabilities - The fair value of derivative warrant liabilities increased by $2.7 million for the year ended March 31, 2024, primarily due to an increase in the company's stock price[303].

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-Q ______________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35776 ______________________________________ A ...

PRINCETON, N.J., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (NASDAQ:ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that a poster outlining its pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405) has been accepted for presentation at the 2024 International Stroke Conference, to be held F ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-Q ______________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35776 ______________________________________ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-Q ______________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35776 ______________________________________ Acast ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35776 ACASTI PHARMA INC. (Exact name of registrant as specified in its charter) Québec, Canada 98-1359336 (State or other jurisdiction ...

Financial Data and Key Metrics Changes - The company ended the third fiscal quarter with $31.3 million in cash, cash equivalents, and short-term investments, down from $34.9 million as of September 30, 2022 [9][35] - Research and development expenses for the quarter totaled $2.5 million, an increase from $2.2 million in the same quarter of the previous year [33] - General and administrative expenses decreased to $1.6 million from $1.8 million year-over-year, attributed to reduced professional fees [33] - The net loss for the quarter was $3.9 million, consistent with the previous year's loss of $3.8 million [34] Business Line Data and Key Metrics Changes - GTX-101, a topical spray for postherpetic neuralgia, successfully met all primary outcome measures in its pharmacokinetic study, allowing advancement to the next clinical stage [11][18] - GTX-102 also met all primary outcome measures in its PK bridging study, paving the way for a Phase 3 safety and efficacy trial [19][24] - GTX-104, aimed at treating aneurysmal subarachnoid hemorrhage, is awaiting FDA guidance to initiate its Phase 3 safety study [25][28] Market Data and Key Metrics Changes - The total addressable market for GTX-101 is estimated at $2.5 billion, with $200 million for PHN pain and $2.3 billion for non-PHN pain [18] - The potential addressable market for GTX-102 in Ataxia Telangiectasia is approximately $150 million, affecting around 4,300 patients annually in the U.S. [22] - The market for GTX-104 addresses a critical need in the care of aSAH patients, a condition with high mortality rates and limited treatment options [26] Company Strategy and Development Direction - The company is focused on leveraging its drug delivery capabilities by reformulating and repurposing marketed drugs for orphan indications with significant unmet medical needs [29][30] - All three drug candidates have received orphan drug designation from the FDA, which may facilitate expedited development and market exclusivity [30] - The strategy includes engaging with key opinion leaders and building relationships with major medical centers to prepare for market adoption upon approval [51][52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming year, anticipating the initiation of Phase 3 studies for GTX-104 and GTX-102 [36] - The company is awaiting FDA guidance on its proposed Phase 3 study designs, which is crucial for moving forward with clinical trials [28] - The management emphasized the importance of addressing the unmet needs of patients with rare diseases through innovative treatments [59] Other Important Information - The company has completed three successful clinical trials, with two reporting results in December 2022 [36] - The company plans to submit a draft protocol to the FDA for GTX-102's Phase 3 study following the final clinical trial report [40] Q&A Session Summary Question: Enrollment timelines and potential timing for GTX-102 - Management is waiting for the final clinical trial report before submitting to the FDA and expects to initiate study startup activities in the second half of the year [40] Question: Clarification on Type C meeting with the FDA for GTX-104 - The company is still waiting for guidance from the FDA and has not yet had the meeting [42][46] Question: Commercial relationships for GTX-104 - The company is building relationships with key opinion leaders and major medical centers to prepare for market adoption [51][52] Question: Update on GTX-101's pharmacodynamics data - The final clinical report is expected in May, and while pharmacodynamics data will be shared, it was not a primary endpoint of the study [56]