SEC 8-K filings with transcript text
Jul 29, 2026
2 exh_991.htm
EdgarFiling
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 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.Fil
May 7, 2026
2 exh_991.htm
EdgarFiling
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
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
Mar 12, 2026
2 exh_991.htm
EdgarFiling
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 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. Thi
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