As the main stock indices like the S&P 500 and Nasdaq continue to climb, penny stocks are becoming attractive for those seeking significant returns. Despite their reputation for extreme price fluctuations and high risk, they offer the potential for impressive gains, especially in a bull market. For May, there are seven penny stocks worth considering. These companies, despite their low market capitalization and liquidity, have solid foundations and promising growth prospects, potentially minting new milliona ...

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]

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, 2022 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 ...

Financial Data and Key Metrics Changes - The company reported a net loss of $4.9 million or $0.11 loss per share for the quarter ended September 30, 2022, compared to a net income of $1 million or $0.03 per share for the same quarter in 2021 [30] - Research and development expenses for the quarter totaled $3.3 million, a significant increase from $0.6 million in the same quarter of the previous year, reflecting the focus on advancing clinical programs [29] - General and administrative expenses decreased to $1.6 million from $2.9 million year-over-year, attributed to reduced professional fees [30] Business Line Data and Key Metrics Changes - GTX-104, the most advanced clinical program, is set to initiate a Phase 3 safety study in the first half of 2023, targeting patients with Subarachnoid Hemorrhage (SAH) [8][18] - GTX-102, a novel oral mucosal spray for Ataxia Telangiectasia, has a potential addressable market of approximately $150 million, with top-line results from a PK study expected by year-end [21][22] - GTX-101, a topical bupivacaine spray for Postherpetic Neuralgia, aims to address significant unmet needs in pain management, with a PK study also expected to be completed by the end of 2022 [23][25] Market Data and Key Metrics Changes - The total available market for GTX-104 in the U.S. is estimated to exceed $300 million, with approximately 50,000 patients affected annually by SAH [19] - The market for GTX-102 is estimated at around $150 million, targeting a patient population of about 4,300 in the U.S. [21] - The company’s market research for GTX-101 indicated a strong demand for faster and more convenient pain relief solutions, validating the product's potential in the market [50] Company Strategy and Development Direction - The company aims to leverage drug delivery technologies to reformulate marketed drugs for orphan indications, utilizing the FDA's Section 505(b)(2) regulatory pathway for potentially shorter and less risky approval processes [12][13] - The strategy includes targeting well-understood orphan diseases with little competition, focusing on improving patient outcomes and quality of life [15] - The company is open to potential partnerships for commercialization, particularly in international markets such as Asia and Europe [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to fund operations through at least March 2024, with sufficient capital to advance GTX-104 into Phase 3 and support GTX-102 and GTX-101 [11][31] - The company anticipates rapid adoption of GTX-104 if approved, due to existing relationships with major healthcare centers [36] - Management highlighted the importance of upcoming milestones, including FDA guidance on the Phase 3 study design for GTX-104 [25] Other Important Information - The company completed a Phase 1 PK bridging study for GTX-104, which met all endpoints, indicating a favorable absorption profile compared to oral nimodipine [16][17] - The company has initiated PK studies for GTX-102 and GTX-101, with results expected to inform further clinical development [22][25] Q&A Session Summary Question: What structure does the company plan to deploy for commercializing GTX-104? - Management indicated that the market is concentrated in major healthcare centers, suggesting a small initial sales force of 15 to 20 representatives, with potential for organic growth [34][35] Question: When can the market expect top-line results for GTX-102? - Management confirmed that top-line results for GTX-102 are expected before the end of December 2022 [37][38] Question: What are the expected timelines for filings for each program? - Management outlined that the GTX-104 study is expected to wrap up by the end of 2024, with a filing anticipated in early 2025 [41][42] Question: What is the expected burn rate going forward? - The CFO indicated a long-term burn rate of about $2 million per month, with expectations for an increase as commercialization efforts ramp up [45] Question: What market research has been conducted for GTX-101? - Management shared that primary research indicated a strong unmet need for GTX-101, with positive feedback from over 250 physicians regarding its potential advantages over current treatments [48][49]