FLNA
Filana TherapeuticsDDocument history
Earnings documents stored for FLNA.
Investor releaseQuarter not tagged2026-07-29Filana Therapeutics Reports Q2 2026 Financial Results and Provides Business Update
GlobeNewswire
Filana Therapeutics Reports Q2 2026 Financial Results and Provides Business Update
AUSTIN, Texas, July 29, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company currently focused on developing therapies for Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the second quarter ended June 30, 2026 and provided a business update. “The Company continues to engage with the FDA regarding the clinical hold on its proof-of-concept trial in TSC-related epilepsy. The Company is working diligently to address the FDA’s request for information in order to have the clinical hold lifted,” said Rick Barry, President and Chief Executive Officer of Filana Therapeutics, Inc. “In the meantime, we continue to work actively with the TSC community. Participation in the TSC World Conference this week will keep us connected and prepared for future development of simufilam as the regulatory process continues.” Scientific Presentations and Publications Publication of Eilat XVIII Proceedings in Epilepsia: Peer-reviewed proceedings of the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices (Eilat XVIII) have been published in Epilepsia. The proceedings include a summary of the biological rationale and preclinical data supporting the Company’s simufilam program in TSC-related epilepsy, consistent with the presentation Filana Therapeutics delivered at the conference in Madrid, Spain, on May 5, 2026 (see Section 7 of the published proceedings)1. TSC Community Engagement Planned Participation in the 2026 TSC World Conference: Filana is a sponsor of the 2026 TSC World Conference, hosted by the TSC Alliance® and Tuberous Sclerosis Complex International (TSCi), to be held July 30 to August 1, 2026, in Aurora, Colorado. The conference, held every four years, promises to be one of the largest TSC gatherings around the globe, covering all aspects of TSC across a patient’s lifespan. Financial Results for Second Quarter 2026 Cash and cash equivalents at June 30, 2026 were $82.7 million, compared to $95.5 million as of December 31, 2025. The Company has no debt. Research and development (R&D) expenses for the second quarter of 2026 were $3.3 million. This compared to $5.1 million for the same period in 2025. This 35% decrease was due primarily to the previously reported phase out of the Alzheimer’s disease development program, completed in the second quart…Read full documentShow less
AUSTIN, Texas, July 29, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company currently focused on developing therapies for Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the second quarter ended June 30, 2026 and provided a business update. “The Company continues to engage with the FDA regarding the clinical hold on its proof-of-concept trial in TSC-related epilepsy. The Company is working diligently to address the FDA’s request for information in order to have the clinical hold lifted,” said Rick Barry, President and Chief Executive Officer of Filana Therapeutics, Inc. “In the meantime, we continue to work actively with the TSC community. Participation in the TSC World Conference this week will keep us connected and prepared for future development of simufilam as the regulatory process continues.” Scientific Presentations and Publications Publication of Eilat XVIII Proceedings in Epilepsia: Peer-reviewed proceedings of the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices (Eilat XVIII) have been published in Epilepsia. The proceedings include a summary of the biological rationale and preclinical data supporting the Company’s simufilam program in TSC-related epilepsy, consistent with the presentation Filana Therapeutics delivered at the conference in Madrid, Spain, on May 5, 2026 (see Section 7 of the published proceedings)1. TSC Community Engagement Planned Participation in the 2026 TSC World Conference: Filana is a sponsor of the 2026 TSC World Conference, hosted by the TSC Alliance® and Tuberous Sclerosis Complex International (TSCi), to be held July 30 to August 1, 2026, in Aurora, Colorado. The conference, held every four years, promises to be one of the largest TSC gatherings around the globe, covering all aspects of TSC across a patient’s lifespan. Financial Results for Second Quarter 2026 Cash and cash equivalents at June 30, 2026 were $82.7 million, compared to $95.5 million as of December 31, 2025. The Company has no debt. Research and development (R&D) expenses for the second quarter of 2026 were $3.3 million. This compared to $5.1 million for the same period in 2025. This 35% decrease was due primarily to the previously reported phase out of the Alzheimer’s disease development program, completed in the second quarter of 2025. Expenses for the TSC-related epilepsy program are expected to be significantly lower compared to those for the Alzheimer’s disease program. General and administrative (G&A) expenses for the second quarter of 2026 were $6.1 million. This compared to $40.3 million for the same period in 2025. The 85% decrease was due primarily to a $31.25 million securities litigation loss contingency recorded in the second quarter of 2025 not being repeated in 2026. Net cash used in operations was $12.7 million during first-half of 2026 and below previous guidance. Litigation Settlement: On July 23, 2026, the Company paid $31.25 million into escrow in connection with the potential settlement of certain securities litigation recorded in 2025. This funding is a step toward final resolution of the matter, and this cash will remain restricted subject to final court approval. Net cash used in operations for second-half 2026 is expected to be in a range from $11 to $15 million, plus the $31.25 million litigation settlement funding described above. The Company estimates unrestricted cash at year-end 2026 in a range from $36 to $40 million. Net loss for the second quarter of 2026 was $8.6 million, or $0.18 per share. This compares to a net loss of $44.2 million, or $0.92 per share, for the same period in 2025. Shares outstanding were 48.3 million as of July 27, 2026. About TSC and TSC-related Epilepsy TSC is a rare genetic disorder resulting from a mutation in the TSC1 or TSC2 gene. These mutations affect the mechanistic target of rapamycin (mTOR) pathway and can cause tumors to grow in multiple organs2,3. Epilepsy is the most common health issue affecting the TSC community, with 80% to 90% of TSC patients experiencing seizures4. TSC-related epilepsy affects approximately 45,000 people in the U.S.2,5 Most patients start having seizures within their first year of life5. Even with multiple approved treatments, more than 60% of TSC patients remain refractory to antiepileptic therapy6. About Filana Therapeutics, Inc. Filana Therapeutics, Inc. (NASDAQ: FLNA), is a biotechnology company focused on developing novel, investigational therapies to modulate the filamin A protein for the treatment of central nervous system disorders, such as tuberous sclerosis complex (TSC)-related epilepsy, and other diseases associated with dysregulation or overexpression of filamin A. For more information, please visit: https://www.FilanaTx.com References: Bialer M, Johannessen Landmark C, Koepp MJ, Perucca E, Perucca P, Tomson T, et al. Progress report on new epilepsy treatments: a summary of the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XVIII). I. Treatments in preclinical and early clinical development. Epilepsia. 2026. doi:10.1002/epi.70354. https://onlinelibrary.wiley.com/doi/full/10.1002/epi.70354 https://www.tscalliance.org/understanding-tsc/what-is-tsc/ https://www.tscalliance.org/understanding-tsc/genetics/ Crino P, Nathanson K, Petri Henske, E. The Tuberous Sclerosis Complex. N Engl J Med. (2006) 355 (13):1345-56. DOI: 10.1056/NEJMra055323 Zhang L, Huang T, Teaw S, Nguyen LH, Hsieh LS, Wong X, Burns LH, Bordey A. Filamin A inhibition reduces seizure activity in a mouse model of focal cortical malformations. Science Translational Medicine. (2020) 12(531):eaay0289. DOI: 10.1126/scitranslmed.aay0289 Chu-Shore, C. J., Major, P., Camposano, S., Muzykewicz, D., & Thiele, E. A. (2010). The natural history of epilepsy in tuberous sclerosis complex. Epilepsia, 51(7), 1236–1241. https://doi.org/10.1111/j.1528-1167.2009.02474.x For More Information Contact:InvestorsMike [email protected] CompanyEric Schoen, Chief Financial Officer(512) [email protected]@FilanaTx.com Cautionary Note Regarding Forward-Looking Statements: This news release contains forward-looking statements that may include but are not limited to statements regarding: our ability to successfully engage with, and satisfactorily respond to, requests for additional information from the U.S. Food and Drug Administration (FDA) concerning the full clinical hold on our investigational new drug application (IND) for simufilam in TSC-related epilepsy and the timing and outcomes of such interactions, the potential resolution of certain securities litigation and our loss contingency estimates related thereto, the timing and plans to conduct clinical studies with simufilam following approval of our IND, our plans to conduct additional preclinical studies of simufilam relating to seizures in TSC, the potential for simufilam as a treatment for TSC-related epilepsy and other potential indications, the timing of anticipated milestones, expected cash balances and cash use in future periods. These statements may be identified by words such as “anticipate”, “before”, “believe”, “could”, “expect”, “forecast”, “intend”, “may”, ”pending”, “plan”, “possible”, “potential”, “prepares for”, “will”, and other words and terms of similar meaning. Such statements are based on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to our ability to provide FDA with additional information, including additional pre-clinical data, and modifying the proposed clinical trial protocol design, to satisfy completion of FDA’s review and release of full clinical hold, the ability to advance preclinical studies related to TSC-related epilepsy, and other potential indications, the ability to initiate an initial proof-of-concept study of simufilam in TSC-related epilepsy, and other risks inherent in drug discovery and development or specific to Filana Therapeutics, Inc., as described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC’s website at www.sec.gov. All of our pharmaceutical assets under development are investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates is approved or available for sale anywhere in the world. Our clinical results from earlier-stage clinical trials or preclinical studies may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish. We are in the business of new drug discovery and development. Our research and development activities are long, complex, costly and involve a high degree of risk. Holders of our common stock should carefully read our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q in their entirety, including the risk factors therein. Because risk is fundamental to the process of drug discovery and development, you are cautioned to not invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested. – Financial Tables Follow –
Investor releaseQuarter not tagged2026-05-07Filana Therapeutics Reports Q1 2026 Financial Results and Business Update
GlobeNewswire
Filana Therapeutics Reports Q1 2026 Financial Results and Business Update
AUSTIN, Texas, May 07, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company currently focused on developing therapies for Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the first quarter ended March 31, 2026 and provided a business update on the development of simufilam, an oral small molecule intended to modulate filamin A protein. “2026 has been a year of important progress and new beginnings for Filana Therapeutics. Our new name reflects who we are—a team dedicated to rigorous science and to bringing new treatment options to patients with TSC-related epilepsy and their families,” said Rick Barry, President and Chief Executive Officer of Filana Therapeutics, Inc. “We believe the recent publication of preclinical data in Epilepsia and our presentation at the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices further support the biological rationale behind simufilam and our approach to the potential treatment of TSC-related epilepsy. We remain focused on generating the necessary data to resolve the FDA’s Clinical Hold and advance the program. We are committed to keeping our stakeholders informed and look forward to sharing updates as they develop.” Recent Updates: Corporate Developments Name Change to Filana Therapeutics: The new name and brand reflect a shared purpose to develop medicines that modulate filamin A – targeting CNS disorders like TSC-related epilepsy and other conditions associated with filamin A dysregulation or overexpression. Regulatory TSC Program Update: The Company is actively working to address FDA’s Clinical Hold, including the planned submission of additional pre-clinical data and protocol design modifications. The timeline for initiation of a clinical trial will depend on the Company’s ability to provide the requested information to FDA and on satisfactory completion of FDA’s review. Scientific Presentations and Publications Presentation of TSC-Related Epilepsy Program Overview at Eilat XVIII: On May 5, 2026, Filana presented an overview of its TSC-related epilepsy program at the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices (Eilat XVIII) in Madrid, Spain. The presentation highlighted the biological rationale supporting continued evaluation of simufilam in TSC-related epilepsy. Publi…Read full documentShow less
AUSTIN, Texas, May 07, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company currently focused on developing therapies for Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the first quarter ended March 31, 2026 and provided a business update on the development of simufilam, an oral small molecule intended to modulate filamin A protein. “2026 has been a year of important progress and new beginnings for Filana Therapeutics. Our new name reflects who we are—a team dedicated to rigorous science and to bringing new treatment options to patients with TSC-related epilepsy and their families,” said Rick Barry, President and Chief Executive Officer of Filana Therapeutics, Inc. “We believe the recent publication of preclinical data in Epilepsia and our presentation at the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices further support the biological rationale behind simufilam and our approach to the potential treatment of TSC-related epilepsy. We remain focused on generating the necessary data to resolve the FDA’s Clinical Hold and advance the program. We are committed to keeping our stakeholders informed and look forward to sharing updates as they develop.” Recent Updates: Corporate Developments Name Change to Filana Therapeutics: The new name and brand reflect a shared purpose to develop medicines that modulate filamin A – targeting CNS disorders like TSC-related epilepsy and other conditions associated with filamin A dysregulation or overexpression. Regulatory TSC Program Update: The Company is actively working to address FDA’s Clinical Hold, including the planned submission of additional pre-clinical data and protocol design modifications. The timeline for initiation of a clinical trial will depend on the Company’s ability to provide the requested information to FDA and on satisfactory completion of FDA’s review. Scientific Presentations and Publications Presentation of TSC-Related Epilepsy Program Overview at Eilat XVIII: On May 5, 2026, Filana presented an overview of its TSC-related epilepsy program at the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices (Eilat XVIII) in Madrid, Spain. The presentation highlighted the biological rationale supporting continued evaluation of simufilam in TSC-related epilepsy. Publication in Epilepsia of Preclinical Simufilam Data: The preclinical data published in Epilepsia showed that simufilam attenuated seizure progression in a well-accepted mouse model of severe TSC-related epilepsy1. The results, together with published findings in an earlier animal model2, underscore a positive correlation between seizure outcomes and plasma exposure to simufilam, supporting the continued evaluation of simufilam for the treatment of TSC-related epilepsy, which affects approximately 45,000 people in the U.S.2,3 Financial Results for First Quarter 2026 Cash and cash equivalents at March 31, 2026 were $86.6 million, compared to $95.5 million as of December 31, 2025. The Company has no debt. The Company estimates cash at June 30, 2026 in a range from $47 to $50 million. Research and development (R&D) expenses were $4.5 million. This compared to $13.7 million for the same period in 2025. This 67% decrease was due primarily to the previously reported phase out of the Alzheimer's disease development program, completed in the second quarter of 2025. Expenses for the TSC-related epilepsy program are expected to be significantly lower compared to those for the Alzheimer's disease program. General and administrative (G&A) expenses were $6.6 million. This compared to $10.9 million for the same period in 2025. The 39% decrease was due primarily to legal loss contingencies of $3.0 million recorded in Q1 2025 not being repeated in 2026. Net cash used in operations was $8.9 million during the first quarter of 2026. Net cash used in operations for first-half 2026 is expected to be in a range from $14 to $17 million, plus a payment of $31.25 million estimated loss contingency related to the potential settlement of certain securities litigation recorded in 2025. Net loss was $10.3 million, or $0.21 per share. This compares to a net loss of $23.4 million, or $0.48 per share, for the same period in 2025. Shares outstanding were 48.3 million as of May 4, 2026. About TSC and TSC-related Epilepsy TSC is a rare genetic disorder resulting from a mutation in the TSC1 or TSC2 gene. These mutations affect the mechanistic target of rapamycin (mTOR) pathway and can cause tumors to grow in multiple organs3,4. Epilepsy is the most common health issue affecting the TSC community, with 80% to 90% of TSC patients experiencing seizures5. TSC-related epilepsy affects approximately 45,000 people in the U.S.2,3 Most patients start having seizures within their first year of life2. Even with multiple approved treatments, more than 60% of TSC patients remain refractory to antiepileptic therapy6. About Filana Therapeutics, Inc. Filana Therapeutics, Inc. (NASDAQ: FLNA), is a biotechnology company focused on developing novel, investigational therapies to modulate the filamin A protein for the treatment of central nervous system disorders, such as tuberous sclerosis complex (TSC)-related epilepsy, and other diseases associated with dysregulation or overexpression of filamin A. For more information, please visit: https://www.FilanaTx.com References: For More Information Contact: Investors Sandya von der Weid [email protected] Company Eric Schoen, Chief Financial Officer (512) 501-2450 [email protected] [email protected] Cautionary Note Regarding Forward-Looking Statements: This news release contains forward-looking statements that may include but are not limited to statements regarding: our ability to successfully engage with, and satisfactorily respond to, requests for additional information from the U.S. Food and Drug Administration (FDA) concerning the full clinical hold on our investigational new drug application (IND) for simufilam in TSC-related epilepsy and the timing and outcomes of such interactions, the potential resolution of certain securities litigation and our loss contingency estimates and timing of payments related thereto, the timing and plans to conduct clinical studies with simufilam following approval of our IND, our plans to conduct additional preclinical studies of simufilam relating to seizures in TSC, the potential for simufilam as a treatment for TSC-related epilepsy and other potential indications, the timing of anticipated milestones, expected cash balances and cash use in future periods. These statements may be identified by words such as “anticipate”, “before”, “believe”, “could”, “expect”, “forecast”, “intend”, “may”, ”pending”, “plan”, “possible”, “potential”, “prepares for”, “will”, and other words and terms of similar meaning. Such statements are based on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to our ability to provide FDA with additional information, including additional pre-clinical data, and modifying the proposed clinical trial protocol design, to satisfy completion of FDA’s review and release of full clinical hold, the ability to advance preclinical studies related to TSC-related epilepsy, and other potential indications, the ability to initiate an initial proof-of-concept study of simufilam in TSC-related epilepsy, and other risks inherent in drug discovery and development or specific to Filana Therapeutics, Inc., as described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at www.sec.gov. All of our pharmaceutical assets under development are investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates is approved or available for sale anywhere in the world. Our clinical results from earlier-stage clinical trials or preclinical studies may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish. We are in the business of new drug discovery and development. Our research and development activities are long, complex, costly and involve a high degree of risk. Holders of our common stock should carefully read our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q in their entirety, including the risk factors therein. Because risk is fundamental to the process of drug discovery and development, you are cautioned to not invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested.
Investor releaseQuarter not tagged2026-03-12Filana Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results
GlobeNewswire
Filana Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results
Working to advance TSC-related epilepsy program, with a focus on capital efficiency AUSTIN, Texas, March 12, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (formerly Cassava Sciences, Inc.) (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company focused on developing novel medicines to modulate the filamin A protein for the treatment of central nervous system (CNS) disorders, such as Tuberous Sclerosis Complex (TSC)-related epilepsy, and other diseases associated with dysregulation or overexpression of filamin A, today reported financial results for the fourth quarter and year ended December 31, 2025, and provided a business update. Net loss for 2025 was $91.0 million, or $1.88 per share, compared to a net loss of $24.3 million, or $0.53 per share (basic), in 2024. Net cash used in operations was $32.3 million in 2025, consistent with previous guidance. The Company met cash guidance for year-end 2025, reporting $95.5 million, and estimates cash at June 30, 2026 in a range from $47 to $50 million. The Company estimates net cash use in operations for first half of 2026 in a range from $14 to $17 million, plus a payment of a $31.25 million estimated loss contingency related to the potential settlement of certain securities litigation recorded in 2025. “At Filana Therapeutics, our name reflects our deep commitment to science and to patients affected by diseases tied to filamin A dysregulation, including TSC-related epilepsy. We are driven by the urgent need for new treatment options that can meaningfully improve patients’ lives,” said Rick Barry, President and Chief Executive Officer of Filana Therapeutics, Inc. “In partnership with our advisors, we are working diligently to address the FDA’s requests and look forward to sharing a progress update in the coming months.” Corporate Updates: Name change to Filana Therapeutics, Inc.: Filana Therapeutics’ new name and brand reflect the Company’s strategic focus on developing novel medicines to modulate the filamin A protein for the treatment of CNS disorders, such as TSC-related epilepsy, and other diseases associated with dysregulation or overexpression of filamin A. TSC Program Update: The Company is actively addressing FDA’s request for information detailed in the Clinical Hold Letter received in December 2025, including the submission of additional pre-clinical data and protocol design mo…Read full documentShow less
Working to advance TSC-related epilepsy program, with a focus on capital efficiency AUSTIN, Texas, March 12, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (formerly Cassava Sciences, Inc.) (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company focused on developing novel medicines to modulate the filamin A protein for the treatment of central nervous system (CNS) disorders, such as Tuberous Sclerosis Complex (TSC)-related epilepsy, and other diseases associated with dysregulation or overexpression of filamin A, today reported financial results for the fourth quarter and year ended December 31, 2025, and provided a business update. Net loss for 2025 was $91.0 million, or $1.88 per share, compared to a net loss of $24.3 million, or $0.53 per share (basic), in 2024. Net cash used in operations was $32.3 million in 2025, consistent with previous guidance. The Company met cash guidance for year-end 2025, reporting $95.5 million, and estimates cash at June 30, 2026 in a range from $47 to $50 million. The Company estimates net cash use in operations for first half of 2026 in a range from $14 to $17 million, plus a payment of a $31.25 million estimated loss contingency related to the potential settlement of certain securities litigation recorded in 2025. “At Filana Therapeutics, our name reflects our deep commitment to science and to patients affected by diseases tied to filamin A dysregulation, including TSC-related epilepsy. We are driven by the urgent need for new treatment options that can meaningfully improve patients’ lives,” said Rick Barry, President and Chief Executive Officer of Filana Therapeutics, Inc. “In partnership with our advisors, we are working diligently to address the FDA’s requests and look forward to sharing a progress update in the coming months.” Corporate Updates: Name change to Filana Therapeutics, Inc.: Filana Therapeutics’ new name and brand reflect the Company’s strategic focus on developing novel medicines to modulate the filamin A protein for the treatment of CNS disorders, such as TSC-related epilepsy, and other diseases associated with dysregulation or overexpression of filamin A. TSC Program Update: The Company is actively addressing FDA’s request for information detailed in the Clinical Hold Letter received in December 2025, including the submission of additional pre-clinical data and protocol design modifications. The Company intends to submit a response to FDA as soon as practicable. Financial Results for the Fourth Quarter and Full Year 2025: Cash and cash equivalents were $95.5 million, with no debt, as of December 31, 2025. This compares to cash and cash equivalents of $128.6 million at December 31, 2024. The Company estimates cash at June 30, 2026, in a range from $47 to $50 million. Total shares outstanding as of March 9, 2026, were 48.3 million. Net loss for the year ended December 31, 2025, was $91.0 million, or $1.88 per share. This compares to a net loss of $24.3 million, or $0.53 per share (basic) for the same period in 2024. Net loss increased primarily due to a $108.1 million gain in 2024 from change in fair value of warrant liabilities that was not repeated in 2025. Net cash used in operations was $32.3 million in 2025, consistent with previous guidance. The Company estimates net cash use in operations for first half of 2026 in a range from $14 to $17 million, plus a payment of $31.25 million estimated loss contingency related to the potential settlement of certain securities litigation recorded in 2025. Research and development (R&D) expenses for the year ended December 31, 2025, decreased to $26.6 million from $69.6 million in 2024, representing a 62% reduction. This decrease was due primarily to the phase out of the Alzheimer's disease (AD) development program beginning the fourth quarter 2024 and completed in second quarter 2025. The Company’s planned clinical program in TSC-related epilepsy is expected to cost significantly less than the discontinued AD program. General and administrative (G&A) expenses for the year ended December 31, 2025, decreased to $68.8 million from $71.8 million in 2024. The 4% decrease was due primarily to a $40.0 million SEC-related loss contingency recorded in 2024, which was partially offset by $9.9 million in insurance recoveries. This compared to a $31.3 million securities litigation loss contingency and $4 million of other litigation contingencies recorded in 2025, for which there were no insurance recoveries. The change also included a $2.6 million increase in stock-based compensation expense due to new awards granted in late 2024, as well as cost decreases as severance costs recorded in the prior year were not repeated in 2025. About TSC and TSC-related Epilepsy TSC is a rare genetic disorder resulting from a mutation in the TSC1 or TSC2 gene. This affects the mechanistic target of rapamycin (mTOR) pathway and can cause tumors to grow in multiple organs1. Epilepsy is the most common health issue affecting the TSC community, with 80% to 90% of TSC patients experiencing seizures1. TSC-related epilepsy affects approximately 45,000 people in the U.S.2 Most patients start having seizures within their first year of life3. Even with multiple approved treatments, more than 60% of TSC patients remain refractory to antiepileptic therapy4. About Filana Therapeutics, Inc. Filana Therapeutics, Inc. (NASDAQ: FLNA), is a biotechnology company focused on developing novel, investigational therapies to modulate the filamin A protein for the treatment of central nervous system disorders, such as tuberous sclerosis complex (TSC)-related epilepsy, and other diseases associated with dysregulation or overexpression of filamin A. For more information, please visit: https://www.FilanaTx.com References: For More Information Contact: Investors Sandya von der Weid [email protected] Company Eric Schoen, Chief Financial Officer (512) 501-2450 [email protected] [email protected] Cautionary Note Regarding Forward-Looking Statements: This news release contains forward-looking statements that may include but are not limited to statements regarding: our ability to successfully engage with, and satisfactorily respond to, requests for additional information from the U.S. Food and Drug Administration (FDA) concerning the full clinical hold on our investigational new drug application (IND) for simufilam in TSC-related epilepsy and the timing and outcomes of such interactions, the potential resolution of certain securities litigation and our loss contingency estimates and timing of payments related thereto, the timing and plans to conduct clinical studies with simufilam following approval of our IND, our plans to conduct additional preclinical studies of simufilam relating to seizures in TSC, the potential for simufilam as a treatment for TSC-related epilepsy and other potential indications, plans to present preclinical results in an upcoming scientific conference or publication, the timing of anticipated milestones, expected cash balances and cash use in future periods. These statements may be identified by words such as “anticipate”, “before”, “believe”, “could”, “expect”, “forecast”, “intend”, “may”, ”pending”, “plan”, “possible”, “potential”, “prepares for”, “will”, and other words and terms of similar meaning. Such statements are based on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to our ability to provide FDA with additional information, including additional pre-clinical data, and modifying the proposed clinical trial protocol design, to satisfy completion of FDA’s review and release of full clinical hold, the ability to advance preclinical studies related to TSC-related epilepsy, and other potential indications, the ability to successfully carry out the Company’s obligations under the Yale License Agreement, the ability to initiate an initial proof-of-concept study of simufilam in TSC-related epilepsy, and other risks inherent in drug discovery and development or specific to Filana Therapeutics, Inc., as described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the period ended September 30, 2025, and subsequent reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at www.sec.gov. All of our pharmaceutical assets under development are investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates is approved or available for sale anywhere in the world. Our clinical results from earlier-stage clinical trials or preclinical studies may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish. We are in the business of new drug discovery and development. Our research and development activities are long, complex, costly and involve a high degree of risk. Holders of our common stock should carefully read our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q in their entirety, including the risk factors therein. Because risk is fundamental to the process of drug discovery and development, you are cautioned to not invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested. – Financial Tables Follow –
TranscriptFY2024 Q32024-11-07FY2024 Q3 earnings call transcript
Earnings source - 65 paragraphs
FY2024 Q3 earnings call transcript
Ladies and gentlemen, welcome to Cassava Sciences' Report for the Third Quarter 2024. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this audio webcast is being recorded. During this call and the question-and-answer session afterwards, representatives of Cassava Sciences may make what are known as forward-looking statements. A forward-looking statement is one that is not historical fact. Forward-looking statements are not guarantees, and they involve risks, uncertainties, and assumptions. Such statements represent current expectations or beliefs concerning future events or future performance. Forward-looking statements are predictions only based upon information currently available to the company. Actual events or results could differ materially from those made in any forward-looking statement due to a number of factors, risks, and uncertainties.
Please refer to Cassava Sciences' recent filings with the SEC, including Forms 10-K and 10-Q, for a description of the factors that could cause the events or results to differ materially from those made in forward-looking statements. Importantly, this conference call contains time-sensitive information that is accurate only as of the date of the live webcast, November 7, 2024. Except as required by law, the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this webcast. It's now my pleasure to turn today's meeting over to Rick Barry, President and Chief Executive Officer. The floor is yours.
Thank you, Noel, for the introduction. Good morning, everyone, and thank you for joining us. With me today is Chris Cook, our Swiss Army knife, and also our General Counsel, as well as Eric Schoen, who I think of as the Chancellor of the Exchequer, also known as our Chief Financial Officer. Dr. Jim Kupiec, our Chief Medical Officer and the star of the August investor call, will not be able to join us today. As you know, we announced the last patient, last visit of our first phase III trial, RETHINK-ALZ, several weeks ago. Database cleanup is ongoing. This is a routine process that takes place at the end of every clinical trial. The purpose is to ensure the accuracy of all information in the database before it is locked and the statistical analysis begins.
We expect to announce the top-line results of the trial before the end of this year. This is an exciting time for us. We remain optimistic that we will see promising data that could ultimately lead to a best-in-class treatment for Alzheimer's, but we will all see whether our optimism is warranted or misplaced before too long. There really isn't much more we can say about the trial until our data are unblinded and revealed to us by our biostatisticians at Pentara Corporation. We look forward to sharing our data with you. As a reminder, we expect to report our biomarker data from a subset of patients from the RETHINK study at the same time as our cognition data. This will involve approximately 100 patients and provide plasma biomarker results for p-tau-217, neurofilament light chain, otherwise known as NfL, glial fibrillary acidic protein, known as GFAP, and total tau.
I want you to be reassured about a couple of things. Given the scrutiny this company has been under, you can expect that we will measure twice and cut once before we report our results. We will be especially careful to be sure that what we report is accurate to the best of our ability. Also, we will report our data to you, whether it is good, bad, or ambiguous. Last week, a team of us from Cassava attended the Clinical Trials on Alzheimer's Disease, or CTAD, conference in Madrid. First, I have to tell you how impressed I am by our clinical team, which is headed by Dr. Kupiec.
If you aren't aware, Jim is a highly respected member of the Alzheimer's research community, having led Pfizer's neuroscience group for many years, and he has surrounded himself with a team of professionals who are cut from the same dedicated cloth. Jim and his team have assembled a virtual all-star team of principal investigators for our Phase III Program. I had the privilege to meet many of the principal investigators from our Phase III Program, as well as the people who ran the operation of their sites. Many of the investigators are considered the best in their business. These are the same investigators who were also involved, for example, in the successful trials for Eli Lilly's donanemab and Eisai's lecanemab.
The many doctors I met decided to participate in our trials because they made their own assessment of simufilam, and they believed that, based on its hypothesized mechanism of action, the drug had a reasonable chance of working. If the trials are successful, they know it would make a difference in the lives of their patients. These doctors live for innovation in Alzheimer's drug discovery, and they want to be involved with something that could make a real difference. They know better than anyone that there is no sure thing in Alzheimer's, but they believe the drug needed to be studied. Additionally, I believe they chose to be involved because of the trust they have in Jim and his remarkable team.
I am really proud to be associated with this team, and I'm truly grateful to these courageous doctors who have given simufilam the opportunity to demonstrate its potential by participating in our trials when it would have been so much easier to have just said no. We witnessed a lot of very interesting presentations at CTAD last week, but there are a few that I want to focus on. You may recall that in our last call, Jim Kupiec spoke of what he calls the biomarker revolution in Alzheimer's disease. There's been an explosion of innovation in plasma and cerebrospinal fluid biomarkers over the last several years. We now find ourselves at a point where commercially available plasma biomarker tests are demonstrating an extremely high correlation with amyloid beta positivity in the brain, as measured by CSF or PET scans.
Neuroscientists believe that the presence of amyloid beta is one of the key hallmarks of Alzheimer's. Research indicates that a patient with amyloid beta and clinical symptoms has Alzheimer's, or if asymptomatic, is clearly at a high risk of developing the disease. One CTAD presentation reported data from biomarker assays developed by companies such as Eli Lilly, Fujirebio, and C2N Diagnostics. All three showed positive predictive values, that is, the probability that a person has the disease given a positive test result of over 90%. I think you'll agree that it should be the postmortem analysis. Why am I bringing this up? Because these types of tools have the power to change the way medicine is practiced, specifically with respect to the Alzheimer's patient journey. You may recall last quarter that I mentioned Cassava's planning for success.
I specifically told you we were significantly expanding our manufacturing capabilities, including ramping up our active pharmaceutical ingredient production. Those activities are being informed by a commercial plan that we've been developing with the help of an experienced industry consultant. I'd like to share with you some of the things that we're thinking about and just beginning to map out. Before I do that, however, you need to understand that I'm not about to give you forecasts. We do not know how the trials will read out, and I'm not trying to hint that we know we're going to be successful. We do not. I'm just describing our vision of the potential opportunity, how we could focus on commercial efforts on that opportunity, and what the market could look like. We all know that up until recently, physicians have had very few tools to diagnose and treat people with Alzheimer's.
Cholinesterase inhibitors are still widely prescribed, even though they are not disease-modifying. Some doctors are prescribing the recently approved monoclonal antibody-based drugs from Lilly and Eisai. Although these new drugs have demonstrated disease-modifying capabilities, they have their own well-known limitations. The primary care physician is typically the first to diagnose or suspect Alzheimer's. To date, these doctors have had few options at hand to help their patients. In fact, research tells us that 85% of patients get their initial diagnosis from the PCP, but quite often, diagnosis is delayed until a patient is in the moderate and advanced stages of the disease due to many factors, including diagnostic uncertainty. Some PCPs don't feel adequately trained to determine a definitive diagnosis. Doctors also struggle with time constraints, stigma, and fear of causing the patient emotional distress, especially when treatment options are so limited.
We envision a world where that PCP does have a treatment option that is superior to cholinesterase inhibitors and doesn't come with the challenges posed by the new monoclonal antibody-based drugs. If that option is twice a day, more oral medication with an excellent safety profile, the PCP would be in a much better position to treat his or her patient. Now, couple that treatment with a readily available, cost-effective, and accurate plasma biomarker diagnostic assay, and PCPs can actually diagnose and treat their patients. Reimagine the number of moments we can preserve if we can accelerate the point at which treatment is initiated by preparing PCPs for this revolutionary opportunity. If we can realize our vision, the doctor could have high confidence in making a diagnosis and then prescribe a drug that is convenient, safe, and effective. What does the market look like?
We know there are approximately seven million patients currently diagnosed with Alzheimer's disease in the United States, but we also know that the disease is underdiagnosed. We know that half the diagnosed Alzheimer's patients are considered to be mild. Our research tells us that 1.2 million Alzheimer's patients are diagnosed in the U.S. each year, but only about 55% of Alzheimer's patients are treated with a prescription drug approved for the disease. I want you to reimagine Alzheimer's disease treatment possibilities should simufilam's approval become a reality. Simufilam is potentially a first-of-a-kind disease-modifying, specialty-like treatment that could be prescribed by a PCP. This is the scenario for which we are planning if our phase III trials are successful. Even if simufilam is successful, it may still take more time than we would prefer before physicians become comfortable using biomarkers like p-tau-217 to diagnose their patients.
We understand that it will take brilliant execution on our part, even if simufilam shows the kind of results we would all like to see. We are up for the challenge, and if the past few months have proven anything about us, it is that this team doesn't shy away from challenging situations. We lean in, and we work our way through them. Our North Star is to be on the front lines of transforming the way this disease is diagnosed and treated so that the patients can experience the moments they deserve with their loved ones. Well, thank you for indulging the vision that motivates all of us at Cassava. I'd now like to turn the call over to Eric Schoen, who will provide you with a financial update. Eric?
Thanks, Rick. Let's start with our cash and cash equivalents.
We ended the September quarter with $149 million in cash. That balance is expected to be sufficient for operations through the conclusion of both ongoing phase III trials and into calendar 2026. Separate from the $149 million of cash is $40 million of restricted cash. That is a new and temporary line on our balance sheet. That bucket is being held in an escrow account for the sole purpose of satisfying the monetary penalty as part of our settlement with the Securities and Exchange Commission that we announced in September. That settlement is still subject to approval by the U.S. District Court, after which the escrow account will be released to the SEC. We don't anticipate any issues with court approval. On the spending side of the equation, net cash used in operations during the nine months ended September 30 was $55.7 million, or roughly $18.5 million each quarter.
Net cash use in operations for the second half of 2024 is expected to be between $80 and $90 million. This is consistent with our previous guidance. That estimate includes the $40 million settlement I just referenced. Considering this spending level, we will believe we will end the year with between $117-$127 million in cash. That is the same amount as guided to in our last quarterly call. No change. Now on to our profit and loss for the quarter. Our net loss was $27.9 million, or $0.58 per share in Q3, compared to a net loss of $25.7 million, or $0.61 per share for the same period in 2023. Research and development expenses for Q3 were $17.7 million. This compared to $23.6 million for the same period last year.
R&D expenses are naturally decreasing as more and more patients complete the phase III studies and roll over into the lower-cost open-label study. General and administrative expenses for Q3 were $12.9 million, compared to $4.3 million for the same quarter last year. The significant increase was due primarily to higher legal-related expenses, which were partially offset by insurance recoveries, increased compensation costs, including severance costs, as well as an increase in stock-based compensation expense due to new awards granted in late 2023 and 2024. Now I'll turn it back to Rick.
Thank you, Eric. Okay. Operator, could you please open the line for questions?
Thank you. At this time, we will be conducting a question-and-answer session. For those of you on your telephone lines, to ask a question you may press star, then one on your touch-tone telephone. If you are using a speakerphone, please pick your headset up.
Please pick up your headset before pressing the keys. To withdraw your question, please press star, then two. At this time, we will pause momentarily to assemble our roster. Our first question comes from Vernon Bernardino from H.C. Wainwright. Please go ahead.
Hi. Good morning, and thanks for taking my question. Congratulations on the progress. Looking forward to those top-line results. The only question I really had is something that has been developed, and I was just wondering if I could get an update on status. And that is the status of Saladax. One thing that would be important for simufilam's success would be the biomarker diagnostic results, as you mentioned. Obviously, p-tau is something that can be used for a biomarker, but I was wondering if you could give us an update on Saladax.
Sure. Thanks, Vernon.
Hi, Rick.
In a world where the diagnostic tools are becoming so good, particularly p-tau-217, we wonder where Saladax is going to fit into that. That doesn't mean we're not going to pursue it. We will. But we're a small company with limited resources, and there are other ways that we could spend our money, such as looking at additional indications for simufilam, and so there's a lot to think about. Once we have results, how do we want to allocate our capital? Do we want to put it into a diagnostic that may be an improvement over some of the diagnostics that are out there, or do we want to pursue other indications? That's the best answer I can give you.
Terrific, and as a follow-up, I was just wondering again what kind of detail will you be providing in the top-line results before year-end as far as biomarkers are concerned?
So in the biomarkers, we will be measuring p-tau-217, NfL, GFAP, total tau, and I think that's it. And this is remembering, we talked about this. In the second trial, we have a lot more. There's more patients, there's some CSF analysis, and there's also imaging analysis.
And can you remind us the time points at which these in the phase III are being measured? From baseline to last visit. Baseline and last visit only?
I believe so. I mean, I could get back to you. There might have been an interim, not analysis. There might have been an interim draw, but I have it in my head that it was the baseline and finish.
Great. Thanks for taking my question. Looking forward to the results of this I mentioned.
Okay. We are too. Thanks.
Thank you. Next question comes from Elemer Piros from Rodman. Please go ahead.
Yes. Good morning. What I'd like to verify, Rick, is that the statistical analysis plan has been locked down with the FDA, and maybe a part of that question is you're talking about the ADAS-Cog and the ADL as co-primary endpoints. Would both of those or either of those have to hit for success? And obviously, there is a different statistical treatment of either of those or both of those scenarios. If you could elaborate, please.
Sure. Thanks, Elemer, and thanks for the question. There's been this, I don't know, misunderstanding about the SAP. And just to make it clear, so we submitted a statistical analysis plan to the FDA, and you submit this to get their comments. And they gave us some comments, which are relatively minor. Now, we would be not very clever if we didn't take their comments into account and incorporate them in our plan.
But we took their comments, we went back to Pentara, put their comments in, had Pentara make some changes, and then the important thing is that you have to sign the SAP before you lock your database. And we've done that. As far as the endpoints of the trial, we have two primary endpoints, as you know. It's ADAS-Cog12, and it's activities of daily living. And our SPA with FDA says we have to hit on both in order to call the trial successful. And there are secondary endpoints, etc., but they matter a lot less than hitting the primaries.
And Rick, the integrated endpoint of iADRS, is that out of the picture, or is that relegated to as a secondary endpoint?
Yeah. Good question. It's a secondary endpoint.
Okay. Now, is there a pre-specified analysis of mild AD patients only? And if you have to go to that sort of analysis, how does the statistics work there?
There is. We are expecting to have an analysis of mild patients as well as moderate, and then the combined. So I think, as you know, roughly 70% of the patients were mild in this trial. The rest were moderates.
Okay. And just one clarification of the p-tau measurement. I think the enrollment criteria was using p-tau-181, and you mentioned that you'll provide analysis of p-tau-217 as how it may change due to treatment. If you could help us understand whether I'm correct in assuming that, and what's the significance of one versus the other? Has the field evolved into looking at p-tau-217 as a more prominent biomarker?
Yeah. You got it, Elemer.
When we started the trial, I think the scientific community with respect to Alzheimer's leaned towards the p-tau-181 as a better biomarker. But here we are, three-plus years later, and I can tell you being at the conference last week, yeah, people still talk a bit about 181. It's a pretty good tool, but 217 is what everybody in Alzheimer's is focused on right now. So I don't know. I think we're measuring 181 at the end of the trial as well, but it's not. I don't think it's going to be that important of a biomarker.
And maybe one last question. As you look through or work through the data cleanup, roughly what proportion of the total data have you been able to clean and set up for the analysis plan at this stage?
I can't blame you for asking the question. It's a great one. We don't want to go there.
So it's still by year-end?
By year-end, definitely.
Okay. Looking forward to it. Thank you very much, Rick.
Thank you. And thanks for the questions.
Thanks. Our next question comes from Matthew Nachtrab. Please go ahead.
Thanks for bringing me on the call. So the vision that you're laying out around the primary care physician is very exciting. I think all investors and humans are excited about that vision. What I wanted to talk about is, as I've studied the phase II and placebo results of hundreds of AD studies, I believe that hopefully we'll repeat that in phase III and show significant improvement for ADAS-Cog12. But I'm also considering a scenario of phase III results showing that mild significantly improved, but an underperformance of moderate, and potentially resulting in the population missing statistical significance. I have two questions kind of related to that.
First is, how are you thinking the company would navigate a subset of patients performing great with the FDA and taking the drug to market if it's the milds only that are significant? And then the second question I have is, many families are reaching out to me asking when they'll get access to the drug in the U.S. and around the world. And if the drug does perform, what's your upper-level thoughts on when you think the drug could hit the market in the U.S. and around the world?
Very good questions, Matt. So with respect to the potential results, and we're all speculating, but well, I guess the overarching thing is we don't want to rely on subgroup analysis.
However, if we showed statistical significance in mild patients, and for some reason we miss our primary endpoints because of the moderates, we would have an interesting choice to make with respect to our REFOCUS trial because we would have the capability to revise our statistical analysis plan and resubmit to FDA to make the second trial put more of the alpha on the milds. That would be a really big decision to do it. With respect to subgroups, and I've spoken to a few investors about this, what we won't do is we're not going to pick out some niche group that seemed to perform really well based on the drug and then try to convince investors that we're going to take that one over the goal line. That's just not a winning argument.
But if you do have 70% of your trial with statistical significance and showing great results in milds, but it's the moderates that have killed your primary endpoint, that's a different story. And we'd have to go and talk to the agency about that. So I wouldn't think that that situation is hopeless, but it's all going to depend on the data and how the agency responds to it. The second question about when will it be available is a good one. We're kind of thinking, in all likelihood, it would be late summer, early fall of 2026, not next year. Eric, just the heart attack that he was just about to have is recovering from. Let's do it. But there's a lot that depends on that. But I think that's a realistic target to get to market.
You could make some really aggressive assumptions that I don't think I would necessarily make to get maybe a few months off that, but that's probably the right ballpark.
I'd like another question, if you don't mind. Can you elaborate a little bit on what other indications you guys think there is the most potential impact from simufilam and how you might prioritize which indications you would pursue after you get past this phase III for Alzheimer's?
Well, I don't want to go into too much detail. I mean, there's a lot of theoreticals where we have some scientific work that was done in the past, but we got to think about how we're going to allocate the resources and the probability of success.
There is one indication that I think most people who know the company pretty well are aware of, and that is there was a study done by a professor at Yale, which was really a pretty fascinating study where she took our drug and built an animal model based upon tuberous sclerosis, the childhood epilepsy part of it, and she's absolutely convinced that the drug would work in that indication. That would be an indication that would not require enormous trials, huge resources. You get an answer pretty quickly. I don't want to say that we're doing that, but that would be kind of a logical place for us to go next. We have some things that we got to work out, but we're working on them.
I know the resources are strapped, but is this something that you guys are able to do some initial groundwork on now or in the recent past on these different indications? Just kind of get the process started.
Well, we can with the one I was just talking about. The others, no. It's more theoretical.
Okay. Thank you very much.
Okay. Thank you, Matt.
Thank you. This was the last question. I will now turn back to Rick Barry for closing remarks. Please go ahead.
Thanks. Well, we really appreciate you joining the call today. We do, to repeat, expect to announce our top-line phase III results before the end of 2024, and we really look forward to sharing them when they're available. Thanks so much for listening.
This does now conclude today's conference. You may now disconnect your lines at this time. Thank you for participation. Goodbye.

