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01/11 11:29
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reveals several negative factors: a delay in the XPro FDA meeting, limited efficacy in the INKmune trial, and cautious partnership progress. While financial losses decreased and cash runway extends to Q4 2026, the need for additional financing looms. The Q&A session highlights uncertainties and management's reluctance to provide detailed guidance. These elements, combined with the lack of a new partnership announcement or strong guidance, suggest a negative stock price movement in the short term.
Net loss attributable to common stockholders Approximately $6.5 million for the quarter ended September 30, 2025, compared with approximately $12.1 million for the comparable period in 2024. This represents a significant reduction in net loss year-over-year, attributed to decreased research and development expenses.
Research and development expenses Approximately $4.9 million for the quarter ended September 30, 2025, compared with approximately $10.1 million for the comparable period in 2024. This represents a reduction in R&D expenses year-over-year, likely due to the completion of certain clinical trials.
General and administrative expenses Approximately $2.5 million for the quarter ended September 30, 2025, compared with approximately $2.2 million for the comparable period in 2024. This represents a slight increase in G&A expenses year-over-year, potentially due to increased operational activities.
Cash and cash equivalents Approximately $27.7 million as of September 30, 2025. The company believes this is sufficient to fund operations into Q4 2026.
Shares of common stock outstanding Approximately 26.6 million shares as of October 30, 2025.
CORDStrom: Preparing for submission for marketing approval in the U.K. and U.S. Demonstrated benefits for patients with recessive dystrophic epidermolysis bullosa (RDEB), including reduced itch and improved quality of life. Potential for systemic treatment and platform expansion to other diseases, including cancer.
XPro: Submitted Phase II MINDFuL trial results for peer-review publication. Positive results in patients with higher baseline inflammation in Alzheimer's disease. Pursuing accelerated regulatory pathway and preparing for end of Phase II meeting with the FDA.
INKmune: Completed Phase II trial in prostate cancer ahead of schedule. Met primary endpoint and two secondary endpoints. Planning a randomized Phase II trial in 2026.
Financial Performance: Net loss reduced to $6.5 million in Q3 2025 from $12.1 million in Q3 2024. Cash and cash equivalents of $27.7 million, sufficient to fund operations into Q4 2026.
Strategic Focus: Transitioned focus from Alzheimer's trial to advancing platform drug programs. Developing three distinct drug platforms in parallel to strengthen opportunities.
Regulatory Approval Challenges: The company is preparing for regulatory submissions for CORDStrom in the U.K. and U.S., which involves complex data analysis and compliance with stringent manufacturing and testing standards. Failures in these areas could delay approvals.
Manufacturing and Testing Risks: The company faces challenges in confirming the mechanisms of action for CORDStrom and validating assays for drug potency, which are critical for regulatory approval. Failures in these processes have historically delayed other drug approvals.
Strategic Execution Risks: The company is managing three different drug platforms simultaneously, which could strain resources and impact the timely advancement of each program.
Alzheimer's Drug Development Challenges: XPro faces inherent challenges in Alzheimer's drug development, including the need for targeted patient selection and demonstrating disease-modifying effects. Regulatory alignment and securing an accelerated approval pathway are critical hurdles.
Financial Risks: The company reported a net loss of $6.5 million for the quarter and has cash reserves sufficient only until Q4 2026, which may limit its ability to fund operations and clinical trials beyond this period without additional financing.
Clinical Trial Risks: The INKmune program in prostate cancer showed limited efficacy in patients with high disease burden, raising concerns about patient selection and trial design for future studies.
CORDStrom Program: The company is preparing for submission for marketing approval to regulatory bodies in the U.K. and the U.S. for CORDStrom, targeting mid-2026 for the U.K. marketing authorization application (MAA) and a few months later for the U.S. biologics licensing application (BLA). The drug has shown potential as a systemic treatment for recessive dystrophic epidermolysis bullosa (RDEB) and may be expanded to other indications in the future.
XPro Platform: The company is pursuing an accelerated regulatory pathway for XPro and preparing for an end of Phase II meeting with the FDA. They expect to receive feedback on the accelerated pathway and meeting minutes in Q1 2026. The drug has shown promise in treating neuroinflammation in Alzheimer's disease, particularly in patients with higher baseline inflammation, and has demonstrated no ARIA-related safety signals.
INKmune Program: The Phase II trial for INKmune in prostate cancer has been completed ahead of schedule, meeting the primary endpoint and two of three secondary endpoints. The company plans to design a randomized Phase II trial during 2026 as resources become available.
Financial Outlook: The company has cash and cash equivalents of approximately $27.7 million as of September 30, 2025, which is expected to fund operations into Q4 2026.
The selected topic was not discussed during the call.
The earnings call presents a mixed sentiment. Positive aspects include strong generative AI revenue growth and successful commerce bookings. However, the renegotiated Salesforce contract and negative cash flow are concerns. The Q&A reveals some uncertainties, such as delayed deals and the impact of the Salesforce contract on guidance. Overall, these factors balance each other, leading to a neutral sentiment. Without market cap data, the stock's reaction is uncertain, but the mixed signals suggest limited short-term movement.
The earnings call reveals several negative factors: a delay in the XPro FDA meeting, limited efficacy in the INKmune trial, and cautious partnership progress. While financial losses decreased and cash runway extends to Q4 2026, the need for additional financing looms. The Q&A session highlights uncertainties and management's reluctance to provide detailed guidance. These elements, combined with the lack of a new partnership announcement or strong guidance, suggest a negative stock price movement in the short term.
The earnings call presents a mixed picture. Financial performance shows a significant net loss due to impairment, but cost-saving measures are in place. Product development is promising with positive feedback on XPro, but faces delays and dependence on partnerships. Market strategy is cautious, focusing on rare diseases. Cash reserves are adequate for the near term. Q&A highlights potential partnerships post-FDA meeting, but uncertainties remain. Overall, the sentiment balances out, leading to a neutral rating, with no strong catalysts for a significant stock price movement in the short term.
The earnings call highlights several concerns: regulatory challenges, financial sustainability issues, and market competition. The Q&A section reveals management's reluctance to provide clear timelines or metrics, which may unsettle investors. The net loss and limited cash reserves further exacerbate financial worries. While there is potential excitement for new therapies, the overall sentiment leans negative due to uncertainties and lack of strong positive catalysts.
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