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01/11 03:33
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reveals a mixed sentiment. While there is progress in clinical trials and a strong cash position due to private placement, increased expenses and net losses are concerning. The Q&A section highlights positive drug safety feedback and trial progression but lacks specifics on enrollment rates, indicating potential uncertainties. The absence of new partnerships or shareholder return plans further tempers enthusiasm. Given these factors, the stock price is likely to remain stable, suggesting a neutral sentiment.
Cash, cash equivalents, and short-term investments $55.3 million as of September 30, 2025, compared to $30 million as of June 30, 2025, and $44.1 million as of the prior year-end. The increase is attributed to net proceeds from the July private placement.
Net cash used in operating activities $21.3 million for the 9 months ended September 30, 2025, compared to $15.6 million for the same period in 2024. The increase is primarily due to a higher net loss in 2025, partially offset by changes in operating assets and liabilities.
R&D expenses $6.4 million for Q3 2025 and $17.9 million for the 9 months ended September 30, 2025, compared to $5 million and $12.6 million for the same periods in 2024. The increase is due to progress in the ReMEDy2 clinical trial, global expansion, and the Phase 2 preeclampsia trial, as well as team expansion. Partially offset by reduced manufacturing process development costs.
General and administrative expenses $2.6 million for Q3 2025 and $7.3 million for the 9 months ended September 30, 2025, compared to $1.9 million and $5.7 million for the same periods in 2024. The increase is due to higher noncash share-based compensation, personnel costs, and increased investor relations, patents, and professional fees.
Net losses $8.6 million for Q3 2025 and $24.0 million for the 9 months ended September 30, 2025, compared to $6.3 million and $16.5 million for the same periods in 2024. The increase is due to higher R&D and administrative expenses.
DM199: Lead product candidate, a recombinant form of the human tissue KLK1 protein, showing potential as a first-in-class disease-modifying treatment for preeclampsia, fetal growth restriction, and acute ischemic stroke. Positive interim results from Phase 2 trial in South Africa validate its biological activity and safety, with no placental barrier crossing. Demonstrated dose-dependent reductions in blood pressure, improved placental perfusion, and endothelial function.
Global Expansion of ReMEDy2 Trial: Progress in the global expansion of the ReMEDy2 clinical trial for stroke treatment. However, enrollment rates are lower than expected due to changes in stroke referral patterns and increased use of tele neurology. Strategies are being developed to address these challenges.
Financial Position: Cash, cash equivalents, and short-term investments increased to $55.3 million as of September 30, 2025, from $30 million in June 2025. Current cash position expected to fund operations into the second half of 2027.
R&D Expenses: Increased to $6.4 million for Q3 2025, up from $5 million in Q3 2024, due to progress in clinical trials and team expansion.
General and Administrative Expenses: Increased to $2.6 million for Q3 2025, up from $1.9 million in Q3 2024, driven by higher personnel costs, share-based compensation, and professional fees.
U.S. Phase 2 Preeclampsia Trial: Preparation underway for a U.S. Phase 2 trial in early onset preeclampsia patients, following a productive pre-IND meeting with the FDA.
Enrollment Challenges in Stroke Trial: Enrollment rates for the ReMEDy2 stroke trial are lower than initially projected due to changes in stroke referral patterns, such as increased use of AI and tele-neurology, which reduce patient transfers to larger research centers. This could delay trial timelines and impact the development of DM199 for stroke treatment.
Financial Losses and Increased Expenses: The company reported higher net losses of $8.6 million for Q3 2025 and $24 million for the first nine months of 2025, compared to the same periods in 2024. Increased R&D and administrative expenses, including costs for clinical trials and team expansion, are contributing to these losses, which could strain financial resources.
Regulatory and Clinical Trial Risks: The company is preparing for a U.S. Phase 2 trial for preeclampsia and implementing protocol amendments for ongoing trials. Any delays or issues in regulatory approvals or trial execution could impact the development timeline and market entry of DM199.
Operational Risks in Global Expansion: The global expansion of the ReMEDy2 trial and other clinical programs increases operational complexity and costs, which could lead to inefficiencies or delays.
Preeclampsia Program: The company plans to expand its clinical study into early onset preeclampsia and fetal growth restriction cohorts. Completion of the expansion cohort is anticipated in the first half of 2026. Parts 1b and 2 protocol amendments are being implemented to refine the treatment regimen. A U.S. Phase 2 trial for early onset preeclampsia patients is being prepared, with updates expected after receiving final meeting minutes from the FDA.
Stroke Program: Enrollment rates for the Phase 2b/3 ReMEDy2 stroke trial have been updated due to changes in stroke referral patterns. The interim analysis based on the first 200 patients is now expected in the second half of 2026. The independent Data Safety Monitoring Board has reported no safety concerns and recommended continued enrollment.
Financial Outlook: The company’s current cash position of $55.3 million is expected to fund planned clinical studies and corporate operations into the second half of 2027.
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The earnings call reveals a mixed sentiment. While there is progress in clinical trials and a strong cash position due to private placement, increased expenses and net losses are concerning. The Q&A section highlights positive drug safety feedback and trial progression but lacks specifics on enrollment rates, indicating potential uncertainties. The absence of new partnerships or shareholder return plans further tempers enthusiasm. Given these factors, the stock price is likely to remain stable, suggesting a neutral sentiment.
The earnings call reveals mixed elements: increased R&D and G&A expenses leading to higher net losses, but also a promising outlook on clinical trials and a strong cash position post-private placement. The Q&A highlights positive sentiment towards leadership and program potential, yet some concerns over enrollment and lack of specific guidance. These factors balance out to a neutral sentiment, with no strong catalysts for significant stock movement in either direction over the next two weeks.
The earnings call reveals financial strain, with a decrease in cash and rising R&D expenses. Supply chain challenges and enrollment issues further raise concerns. Although there is potential in the preeclampsia program, uncertainties in laboratory results and management's unclear responses about U.S. expansion contribute to a negative outlook. The lack of clear guidance and financial stability issues suggest a stock price decline of -2% to -8%.
The earnings call highlighted several risks including financial, operational, regulatory, and market challenges. Despite ongoing clinical trials and expansions, there's a decrease in cash and investments, increased R&D expenses, and no share repurchase program, indicating potential liquidity issues. The Q&A session revealed uncertainties in regulatory timelines and expansion plans. These factors suggest a negative sentiment, likely leading to a stock price decrease of -2% to -8% over the next two weeks.
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