{"success":true,"data":{"pressRelease":{"id":"101930","rtpr_id":"nGNX8P0Wj","ticker":"FLNA","exchange":"NASDAQ","all_tickers":["FLNA"],"title":"Filana Therapeutics Reports Q2 2026 Financial Results and Provides Business Update","author":"Globe Newswire","published_at":"2026-07-29T12:00:01.032Z","article_body":"AUSTIN, Texas, July 29, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc.\n(NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology\ncompany currently focused on developing therapies for Tuberous Sclerosis\nComplex (TSC)-related epilepsy, today reported financial results for the\nsecond quarter ended June 30, 2026 and provided a business update.\n\n“The Company continues to engage with the FDA regarding the clinical hold on\nits proof-of-concept trial in TSC-related epilepsy. The Company is working\ndiligently to address the FDA’s request for information in order to have the\nclinical hold lifted,” said Rick Barry, President and Chief Executive\nOfficer of Filana Therapeutics, Inc. “In the meantime, we continue to work\nactively with the TSC community. Participation in the TSC World Conference\nthis week will keep us connected and prepared for future development of\nsimufilam as the regulatory process continues.”\n\nScientific Presentations and Publications\n* Publication of Eilat XVIII Proceedings in Epilepsia: Peer-reviewed\nproceedings of the Eighteenth Eilat Conference on New Antiepileptic Drugs and\nDevices (Eilat XVIII) have been published in Epilepsia. The proceedings\ninclude a summary of the biological rationale and preclinical data supporting\nthe Company’s simufilam program in TSC-related epilepsy, consistent with the\npresentation Filana Therapeutics delivered at the conference in Madrid, Spain,\non May 5, 2026 (see Section 7 of the published proceedings\n(https://onlinelibrary.wiley.com/doi/full/10.1002/epi.70354))(1).\nTSC Community Engagement\n* Planned Participation in the 2026 TSC World Conference: Filana is a sponsor\nof the 2026 TSC World Conference, hosted by the TSC Alliance® and Tuberous\nSclerosis Complex International (TSCi), to be held July 30 to August 1, 2026,\nin Aurora, Colorado. The conference, held every four years, promises to be one\nof the largest TSC gatherings around the globe, covering all aspects of TSC\nacross a patient’s lifespan.\nFinancial Results for Second Quarter 2026\n* Cash and cash equivalents at June 30, 2026 were $82.7 million, compared to\n$95.5 million as of December 31, 2025. The Company has no debt.\n* Research and development (R&D) expenses for the second quarter of 2026 were\n$3.3 million. This compared to $5.1 million for the same period in 2025. This\n35% decrease was due primarily to the previously reported phase out of the\nAlzheimer’s disease development program, completed in the second quarter of\n2025. Expenses for the TSC-related epilepsy program are expected to be\nsignificantly lower compared to those for the Alzheimer’s disease program.\n* General and administrative (G&A) expenses for the second quarter of 2026\nwere $6.1 million. This compared to $40.3 million for the same period in 2025.\nThe 85% decrease was due primarily to a $31.25 million securities litigation\nloss contingency recorded in the second quarter of 2025 not being repeated in\n2026.\n* Net cash used in operations was $12.7 million during first-half of 2026 and\nbelow previous guidance.\n* Litigation Settlement: On July 23, 2026, the Company paid $31.25 million\ninto escrow in connection with the potential settlement of certain securities\nlitigation recorded in 2025. This funding is a step toward final resolution of\nthe matter, and this cash will remain restricted subject to final court\napproval.\n* Net cash used in operations for second-half 2026 is expected to be in a\nrange from $11 to $15 million, plus the $31.25 million litigation settlement\nfunding described above. The Company estimates unrestricted cash at year-end\n2026 in a range from $36 to $40 million.\n* Net loss for the second quarter of 2026 was $8.6 million, or $0.18 per\nshare. This compares to a net loss of $44.2 million, or $0.92 per share, for\nthe same period in 2025.\n* Shares outstanding were 48.3 million as of July 27, 2026.\nAbout TSC and TSC-related Epilepsy\n\nTSC is a rare genetic disorder resulting from a mutation in the TSC1 or TSC2\ngene. These mutations affect the mechanistic target of rapamycin (mTOR)\npathway and can cause tumors to grow in multiple organs(2)(,)(3). Epilepsy is\nthe most common health issue affecting the TSC community, with 80% to 90% of\nTSC patients experiencing seizures(4). TSC-related epilepsy affects\napproximately 45,000 people in the U.S.(2,)(5) Most patients start having\nseizures within their first year of life(5). Even with multiple approved\ntreatments, more than 60% of TSC patients remain refractory to antiepileptic\ntherapy(6).\n\nAbout Filana Therapeutics, Inc.\n\nFilana Therapeutics, Inc. (NASDAQ: FLNA), is a biotechnology company focused\non developing novel, investigational therapies to modulate the filamin A\nprotein for the treatment of central nervous system disorders, such as\ntuberous sclerosis complex (TSC)-related epilepsy, and other diseases\nassociated with dysregulation or overexpression of filamin A.\n\nFor more information, please visit: https://www.FilanaTx.com\n\nReferences:\n1. Bialer M, Johannessen Landmark C, Koepp MJ, Perucca E, Perucca P, Tomson T,\net al. Progress report on new epilepsy treatments: a summary of the Eighteenth\nEilat Conference on New Antiepileptic Drugs and Devices (EILAT XVIII). I.\nTreatments in preclinical and early clinical development. Epilepsia. 2026.\ndoi:10.1002/epi.70354.\nhttps://onlinelibrary.wiley.com/doi/full/10.1002/epi.70354\n2. https://www.tscalliance.org/understanding-tsc/what-is-tsc/\n3. https://www.tscalliance.org/understanding-tsc/genetics/\n4. Crino P, Nathanson K, Petri Henske, E. The Tuberous Sclerosis Complex. N\nEngl J Med. (2006) 355 (13):1345-56. DOI: 10.1056/NEJMra055323\n(https://www.nejm.org/doi/abs/10.1056/NEJMra055323)\n5. Zhang L, Huang T, Teaw S, Nguyen LH, Hsieh LS, Wong X, Burns LH, Bordey A.\nFilamin A inhibition reduces seizure activity in a mouse model of focal\ncortical malformations (https://pmc.ncbi.nlm.nih.gov/articles/PMC12290962/).\nScience Translational Medicine. (2020) 12(531):eaay0289. DOI: 10.112\n(https://pmc.ncbi.nlm.nih.gov/articles/PMC12290962/)6/scitranslmed.aay0289\n(https://pmc.ncbi.nlm.nih.gov/articles/PMC12290962/)\n6. Chu-Shore, C. J., Major, P., Camposano, S., Muzykewicz, D., & Thiele, E. A.\n(2010). The natural history of epilepsy in tuberous sclerosis complex.\nEpilepsia, 51(7), 1236–1241.\nhttps://doi.org/10.1111/j.1528-1167.2009.02474.x\nFor More Information Contact:\nInvestors\nMike Moyer\nmmoyer@lifesciadvisors.com\n\nCompany\nEric Schoen, Chief Financial Officer\n(512) 501-2450\nESchoen@FilanaTx.com\nIR@FilanaTx.com\n\nCautionary Note Regarding Forward-Looking Statements:\n\nThis news release contains forward-looking statements that may include but are\nnot limited to statements regarding: our ability to successfully engage with,\nand satisfactorily respond to, requests for additional information from the\nU.S. Food and Drug Administration (FDA) concerning the full clinical hold on\nour investigational new drug application (IND) for simufilam in TSC-related\nepilepsy and the timing and outcomes of such interactions, the potential\nresolution of certain securities litigation and our loss contingency estimates\nrelated thereto, the timing and plans to conduct clinical studies with\nsimufilam following approval of our IND, our plans to conduct additional\npreclinical studies of simufilam relating to seizures in TSC, the potential\nfor simufilam as a treatment for TSC-related epilepsy and other potential\nindications, the timing of anticipated milestones, expected cash balances and\ncash use in future periods. These statements may be identified by words such\nas “anticipate”, “before”, “believe”, “could”, “expect”,\n“forecast”, “intend”, “may”, ”pending”, “plan”,\n“possible”, “potential”, “prepares for”, “will”, and other\nwords and terms of similar meaning.\n\nSuch statements are based on our current expectations and projections about\nfuture events. Such statements speak only as of the date of this news release\nand are subject to a number of risks, uncertainties and assumptions,\nincluding, but not limited to, those risks relating to our ability to provide\nFDA with additional information, including additional pre-clinical data, and\nmodifying the proposed clinical trial protocol design, to satisfy completion\nof FDA’s review and release of full clinical hold, the ability to advance\npreclinical studies related to TSC-related epilepsy, and other potential\nindications, the ability to initiate an initial proof-of-concept study of\nsimufilam in TSC-related epilepsy, and other risks inherent in drug discovery\nand development or specific to Filana Therapeutics, Inc., as described in the\nsection entitled “Risk Factors” in our Annual Report on Form 10-K for the\nyear ended December 31, 2025 and subsequent reports to be filed with\nthe SEC. The foregoing sets forth many, but not all, of the factors that\ncould cause actual results to differ from expectations in any forward-looking\nstatement. In light of these risks, uncertainties and assumptions, the\nforward-looking statements and events discussed in this news release are\ninherently uncertain and may not occur, and actual results could differ\nmaterially and adversely from those anticipated or implied in the\nforward-looking statements. Accordingly, you should not rely upon\nforward-looking statements as predictions of future events. Except as required\nby law, we disclaim any intention or responsibility for updating or revising\nany forward-looking statements. For further information regarding these and\nother risks related to our business, investors should consult our filings with\nthe SEC, which are available on the SEC’s website at www.sec.gov.\n\nAll of our pharmaceutical assets under development are investigational product\ncandidates. These have not been approved for use in any medical indication by\nany regulatory authority in any jurisdiction and their safety, efficacy or\nother desirable attributes, if any, have not been established in any patient\npopulation. Consequently, none of our product candidates is approved or\navailable for sale anywhere in the world.\n\nOur clinical results from earlier-stage clinical trials or preclinical studies\nmay not be indicative of future results from later-stage or larger scale\nclinical trials and do not ensure regulatory approval. You should not place\nundue reliance on these statements or any scientific data we present or\npublish.\n\nWe are in the business of new drug discovery and development. Our research and\ndevelopment activities are long, complex, costly and involve a high degree of\nrisk. Holders of our common stock should carefully read our Annual Report on\nForm 10-K and subsequent Quarterly Reports on Form 10-Q in their entirety,\nincluding the risk factors therein. Because risk is fundamental to the process\nof drug discovery and development, you are cautioned to not invest in our\npublicly traded securities unless you are prepared to sustain a total loss of\nthe money you have invested.\n\n– Financial Tables Follow –\n\n FILANA THERAPEUTICS, INC. \n CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS \n (unaudited, in thousands, except per share amounts) \n \n Three months ended June 30, Six months ended June 30, \n 2026 2025 2026 2025 \n Operating expenses \n Research and development $ 3,303 $ 5,116 $ 7,847 $ 18,782 \n General and administrative 6,090 40,276 12,714 51,196 \n Total operating expenses 9,393 45,392 20,561 69,978 \n Operating loss (9,393 ) (45,392 ) (20,561 ) (69,978 ) \n Interest income 747 1,214 1,536 2,479 \n Other income (loss), net 43 (46 ) 91 (128 ) \n Net loss $ (8,603 ) $ (44,224 ) $ (18,934 ) $ (67,627 ) \n \n Net loss per share, basic and diluted $ (0.18 ) $ (0.92 ) $ (0.39 ) $ (1.40 ) \n \n Weighted-average shares used in computing net loss per share, basic and diluted 48,308 48,308 48,308 48,285 \n \n CONDENSED CONSOLIDATED BALANCE SHEETS \n (unaudited, in thousands) \n June 30, 2026 December 31, 2025 \n Assets \n Current assets \n Cash and cash equivalents $ 82,681 $ 95,502 \n Prepaid expenses and other current assets 1,042 2,207 \n Total current assets 83,723 97,709 \n Property and equipment, net 20,180 20,646 \n Total assets $ 103,903 $ 118,355 \n Liabilities and stockholders’ equity \n Current liabilities \n Accounts payable and other accrued expenses $ 39,291 $ 41,647 \n Accrued development expense 361 364 \n Accrued compensation and benefits 385 1,625 \n Other current liabilities 121 198 \n Total current liabilities 40,158 43,834 \n Other non-current liabilities 136 118 \n Total liabilities 40,294 43,952 \n Stockholders’ equity \n Common Stock and additional paid-in-capital 578,627 570,487 \n Accumulated deficit (515,018 ) (496,084 ) \n Total stockholders’ equity 63,609 74,403 \n Total liabilities and stockholders’ equity $ 103,903 $ 118,355 \n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/984a6554-2b2a-4cf7-9a32-72ac808d52ac)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX8P0Wj","title":"Filana Therapeutics Reports Q2 2026 Financial Results and Provides Business Update","author":"Globe Newswire","ticker":"FLNA","created":"2026-07-29T12:00:01.032Z","tickers":["FLNA"],"exchange":"NASDAQ","article_body":"AUSTIN, Texas, July 29, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc.\n(NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology\ncompany currently focused on developing therapies for Tuberous Sclerosis\nComplex (TSC)-related epilepsy, today reported financial results for the\nsecond quarter ended June 30, 2026 and provided a business update.\n\n“The Company continues to engage with the FDA regarding the clinical hold on\nits proof-of-concept trial in TSC-related epilepsy. The Company is working\ndiligently to address the FDA’s request for information in order to have the\nclinical hold lifted,” said Rick Barry, President and Chief Executive\nOfficer of Filana Therapeutics, Inc. “In the meantime, we continue to work\nactively with the TSC community. Participation in the TSC World Conference\nthis week will keep us connected and prepared for future development of\nsimufilam as the regulatory process continues.”\n\nScientific Presentations and Publications\n* Publication of Eilat XVIII Proceedings in Epilepsia: Peer-reviewed\nproceedings of the Eighteenth Eilat Conference on New Antiepileptic Drugs and\nDevices (Eilat XVIII) have been published in Epilepsia. The proceedings\ninclude a summary of the biological rationale and preclinical data supporting\nthe Company’s simufilam program in TSC-related epilepsy, consistent with the\npresentation Filana Therapeutics delivered at the conference in Madrid, Spain,\non May 5, 2026 (see Section 7 of the published proceedings\n(https://onlinelibrary.wiley.com/doi/full/10.1002/epi.70354))(1).\nTSC Community Engagement\n* Planned Participation in the 2026 TSC World Conference: Filana is a sponsor\nof the 2026 TSC World Conference, hosted by the TSC Alliance® and Tuberous\nSclerosis Complex International (TSCi), to be held July 30 to August 1, 2026,\nin Aurora, Colorado. The conference, held every four years, promises to be one\nof the largest TSC gatherings around the globe, covering all aspects of TSC\nacross a patient’s lifespan.\nFinancial Results for Second Quarter 2026\n* Cash and cash equivalents at June 30, 2026 were $82.7 million, compared to\n$95.5 million as of December 31, 2025. The Company has no debt.\n* Research and development (R&D) expenses for the second quarter of 2026 were\n$3.3 million. This compared to $5.1 million for the same period in 2025. This\n35% decrease was due primarily to the previously reported phase out of the\nAlzheimer’s disease development program, completed in the second quarter of\n2025. Expenses for the TSC-related epilepsy program are expected to be\nsignificantly lower compared to those for the Alzheimer’s disease program.\n* General and administrative (G&A) expenses for the second quarter of 2026\nwere $6.1 million. This compared to $40.3 million for the same period in 2025.\nThe 85% decrease was due primarily to a $31.25 million securities litigation\nloss contingency recorded in the second quarter of 2025 not being repeated in\n2026.\n* Net cash used in operations was $12.7 million during first-half of 2026 and\nbelow previous guidance.\n* Litigation Settlement: On July 23, 2026, the Company paid $31.25 million\ninto escrow in connection with the potential settlement of certain securities\nlitigation recorded in 2025. This funding is a step toward final resolution of\nthe matter, and this cash will remain restricted subject to final court\napproval.\n* Net cash used in operations for second-half 2026 is expected to be in a\nrange from $11 to $15 million, plus the $31.25 million litigation settlement\nfunding described above. The Company estimates unrestricted cash at year-end\n2026 in a range from $36 to $40 million.\n* Net loss for the second quarter of 2026 was $8.6 million, or $0.18 per\nshare. This compares to a net loss of $44.2 million, or $0.92 per share, for\nthe same period in 2025.\n* Shares outstanding were 48.3 million as of July 27, 2026.\nAbout TSC and TSC-related Epilepsy\n\nTSC is a rare genetic disorder resulting from a mutation in the TSC1 or TSC2\ngene. These mutations affect the mechanistic target of rapamycin (mTOR)\npathway and can cause tumors to grow in multiple organs(2)(,)(3). Epilepsy is\nthe most common health issue affecting the TSC community, with 80% to 90% of\nTSC patients experiencing seizures(4). TSC-related epilepsy affects\napproximately 45,000 people in the U.S.(2,)(5) Most patients start having\nseizures within their first year of life(5). Even with multiple approved\ntreatments, more than 60% of TSC patients remain refractory to antiepileptic\ntherapy(6).\n\nAbout Filana Therapeutics, Inc.\n\nFilana Therapeutics, Inc. (NASDAQ: FLNA), is a biotechnology company focused\non developing novel, investigational therapies to modulate the filamin A\nprotein for the treatment of central nervous system disorders, such as\ntuberous sclerosis complex (TSC)-related epilepsy, and other diseases\nassociated with dysregulation or overexpression of filamin A.\n\nFor more information, please visit: https://www.FilanaTx.com\n\nReferences:\n1. Bialer M, Johannessen Landmark C, Koepp MJ, Perucca E, Perucca P, Tomson T,\net al. Progress report on new epilepsy treatments: a summary of the Eighteenth\nEilat Conference on New Antiepileptic Drugs and Devices (EILAT XVIII). I.\nTreatments in preclinical and early clinical development. Epilepsia. 2026.\ndoi:10.1002/epi.70354.\nhttps://onlinelibrary.wiley.com/doi/full/10.1002/epi.70354\n2. https://www.tscalliance.org/understanding-tsc/what-is-tsc/\n3. https://www.tscalliance.org/understanding-tsc/genetics/\n4. Crino P, Nathanson K, Petri Henske, E. The Tuberous Sclerosis Complex. N\nEngl J Med. (2006) 355 (13):1345-56. DOI: 10.1056/NEJMra055323\n(https://www.nejm.org/doi/abs/10.1056/NEJMra055323)\n5. Zhang L, Huang T, Teaw S, Nguyen LH, Hsieh LS, Wong X, Burns LH, Bordey A.\nFilamin A inhibition reduces seizure activity in a mouse model of focal\ncortical malformations (https://pmc.ncbi.nlm.nih.gov/articles/PMC12290962/).\nScience Translational Medicine. (2020) 12(531):eaay0289. DOI: 10.112\n(https://pmc.ncbi.nlm.nih.gov/articles/PMC12290962/)6/scitranslmed.aay0289\n(https://pmc.ncbi.nlm.nih.gov/articles/PMC12290962/)\n6. Chu-Shore, C. J., Major, P., Camposano, S., Muzykewicz, D., & Thiele, E. A.\n(2010). The natural history of epilepsy in tuberous sclerosis complex.\nEpilepsia, 51(7), 1236–1241.\nhttps://doi.org/10.1111/j.1528-1167.2009.02474.x\nFor More Information Contact:\nInvestors\nMike Moyer\nmmoyer@lifesciadvisors.com\n\nCompany\nEric Schoen, Chief Financial Officer\n(512) 501-2450\nESchoen@FilanaTx.com\nIR@FilanaTx.com\n\nCautionary Note Regarding Forward-Looking Statements:\n\nThis news release contains forward-looking statements that may include but are\nnot limited to statements regarding: our ability to successfully engage with,\nand satisfactorily respond to, requests for additional information from the\nU.S. Food and Drug Administration (FDA) concerning the full clinical hold on\nour investigational new drug application (IND) for simufilam in TSC-related\nepilepsy and the timing and outcomes of such interactions, the potential\nresolution of certain securities litigation and our loss contingency estimates\nrelated thereto, the timing and plans to conduct clinical studies with\nsimufilam following approval of our IND, our plans to conduct additional\npreclinical studies of simufilam relating to seizures in TSC, the potential\nfor simufilam as a treatment for TSC-related epilepsy and other potential\nindications, the timing of anticipated milestones, expected cash balances and\ncash use in future periods. These statements may be identified by words such\nas “anticipate”, “before”, “believe”, “could”, “expect”,\n“forecast”, “intend”, “may”, ”pending”, “plan”,\n“possible”, “potential”, “prepares for”, “will”, and other\nwords and terms of similar meaning.\n\nSuch statements are based on our current expectations and projections about\nfuture events. Such statements speak only as of the date of this news release\nand are subject to a number of risks, uncertainties and assumptions,\nincluding, but not limited to, those risks relating to our ability to provide\nFDA with additional information, including additional pre-clinical data, and\nmodifying the proposed clinical trial protocol design, to satisfy completion\nof FDA’s review and release of full clinical hold, the ability to advance\npreclinical studies related to TSC-related epilepsy, and other potential\nindications, the ability to initiate an initial proof-of-concept study of\nsimufilam in TSC-related epilepsy, and other risks inherent in drug discovery\nand development or specific to Filana Therapeutics, Inc., as described in the\nsection entitled “Risk Factors” in our Annual Report on Form 10-K for the\nyear ended December 31, 2025 and subsequent reports to be filed with\nthe SEC. The foregoing sets forth many, but not all, of the factors that\ncould cause actual results to differ from expectations in any forward-looking\nstatement. In light of these risks, uncertainties and assumptions, the\nforward-looking statements and events discussed in this news release are\ninherently uncertain and may not occur, and actual results could differ\nmaterially and adversely from those anticipated or implied in the\nforward-looking statements. Accordingly, you should not rely upon\nforward-looking statements as predictions of future events. Except as required\nby law, we disclaim any intention or responsibility for updating or revising\nany forward-looking statements. For further information regarding these and\nother risks related to our business, investors should consult our filings with\nthe SEC, which are available on the SEC’s website at www.sec.gov.\n\nAll of our pharmaceutical assets under development are investigational product\ncandidates. These have not been approved for use in any medical indication by\nany regulatory authority in any jurisdiction and their safety, efficacy or\nother desirable attributes, if any, have not been established in any patient\npopulation. Consequently, none of our product candidates is approved or\navailable for sale anywhere in the world.\n\nOur clinical results from earlier-stage clinical trials or preclinical studies\nmay not be indicative of future results from later-stage or larger scale\nclinical trials and do not ensure regulatory approval. You should not place\nundue reliance on these statements or any scientific data we present or\npublish.\n\nWe are in the business of new drug discovery and development. Our research and\ndevelopment activities are long, complex, costly and involve a high degree of\nrisk. Holders of our common stock should carefully read our Annual Report on\nForm 10-K and subsequent Quarterly Reports on Form 10-Q in their entirety,\nincluding the risk factors therein. Because risk is fundamental to the process\nof drug discovery and development, you are cautioned to not invest in our\npublicly traded securities unless you are prepared to sustain a total loss of\nthe money you have invested.\n\n– Financial Tables Follow –\n\n FILANA THERAPEUTICS, INC. \n CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS \n (unaudited, in thousands, except per share amounts) \n \n Three months ended June 30, Six months ended June 30, \n 2026 2025 2026 2025 \n Operating expenses \n Research and development $ 3,303 $ 5,116 $ 7,847 $ 18,782 \n General and administrative 6,090 40,276 12,714 51,196 \n Total operating expenses 9,393 45,392 20,561 69,978 \n Operating loss (9,393 ) (45,392 ) (20,561 ) (69,978 ) \n Interest income 747 1,214 1,536 2,479 \n Other income (loss), net 43 (46 ) 91 (128 ) \n Net loss $ (8,603 ) $ (44,224 ) $ (18,934 ) $ (67,627 ) \n \n Net loss per share, basic and diluted $ (0.18 ) $ (0.92 ) $ (0.39 ) $ (1.40 ) \n \n Weighted-average shares used in computing net loss per share, basic and diluted 48,308 48,308 48,308 48,285 \n \n CONDENSED CONSOLIDATED BALANCE SHEETS \n (unaudited, in thousands) \n June 30, 2026 December 31, 2025 \n Assets \n Current assets \n Cash and cash equivalents $ 82,681 $ 95,502 \n Prepaid expenses and other current assets 1,042 2,207 \n Total current assets 83,723 97,709 \n Property and equipment, net 20,180 20,646 \n Total assets $ 103,903 $ 118,355 \n Liabilities and stockholders’ equity \n Current liabilities \n Accounts payable and other accrued expenses $ 39,291 $ 41,647 \n Accrued development expense 361 364 \n Accrued compensation and benefits 385 1,625 \n Other current liabilities 121 198 \n Total current liabilities 40,158 43,834 \n Other non-current liabilities 136 118 \n Total liabilities 40,294 43,952 \n Stockholders’ equity \n Common Stock and additional paid-in-capital 578,627 570,487 \n Accumulated deficit (515,018 ) (496,084 ) \n Total stockholders’ equity 63,609 74,403 \n Total liabilities and stockholders’ equity $ 103,903 $ 118,355 \n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/984a6554-2b2a-4cf7-9a32-72ac808d52ac)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-07-29T12:00:01.456069101Z","server_sent_at_ms":1785326401456},"received_at":"2026-07-29T12:00:01.505Z","source_url":"https://www.globenewswire.com/news-release/2026/07/29/3335160/8339/en/filana-therapeutics-reports-q2-2026-financial-results-and-provides-business-update.html"},"analysis":{"id":"90950","press_release_id":"101930","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Lead program (simufilam) remains under FDA clinical hold with no resolution date","$31.25M restricted for litigation settlement reduces liquidity runway"],"eventType":"earnings","narrative":"Filana Therapeutics reported a narrower net loss of $8.6 million ($0.18 per share) for Q2 2026, compared to a loss of $44.2 million in the prior year, primarily due to the absence of a large litigation charge recorded in 2025.\n\nCash position decreased to $82.7 million from $95.5 million at year-end, with $31.25 million moved to restricted escrow for a potential litigation settlement, leaving estimated unrestricted cash of $36–$40 million by year-end.\n\nThe company continues to engage with the FDA regarding the clinical hold on its simufilam trial for TSC-related epilepsy, with no update on when the hold might be lifted.","sentiment":"mixed","agentHooks":{"shouldPost":false,"suggestedAngle":"Earnings improvement is overshadowed by persistent FDA clinical hold on lead asset and cash pressure from litigation settlement."},"keyFigures":{"customDimensions":{"net_loss":8600000,"ga_expenses":6100000,"rd_expenses":3300000,"cash_position":82700000,"net_cash_used_operations_h1":12700000,"litigation_settlement_payment":31250000,"projected_unrestricted_cash_year_end":"36 to 40 million"}},"quotedText":"The Company continues to engage with the FDA regarding the clinical hold on its proof-of-concept trial in TSC-related epilepsy.","namedEntities":{"people":[{"name":"Rick Barry","role":"President and CEO"},{"name":"Eric Schoen","role":"CFO"},{"name":"Mike Moyer","role":"Investor Contact"}],"products":["simufilam"],"companies":[{"name":"Filana Therapeutics, Inc.","ticker":"FLNA"},{"name":"TSC Alliance","relationship":"conference host"},{"name":"Tuberous Sclerosis Complex International","relationship":"conference host"}],"dollarAmounts":[{"amount":"$82.7 million","context":"Cash and cash equivalents at June 30, 2026"},{"amount":"$95.5 million","context":"Cash and cash equivalents at December 31, 2025"},{"amount":"$3.3 million","context":"Q2 2026 R&D expenses"},{"amount":"$6.1 million","context":"Q2 2026 G&A expenses"},{"amount":"$31.25 million","context":"Litigation settlement payment into escrow"},{"amount":"$36 to $40 million","context":"Estimated unrestricted cash at year-end 2026"},{"amount":"$8.6 million","context":"Q2 2026 net loss"},{"amount":"$0.18 per share","context":"Q2 2026 net loss per share"}]},"materialImpact":{"score":3,"reasoning":"Financials improved significantly due to lapping prior-year litigation charges, but the company's lead program (simufilam) remains under an FDA clinical hold, and a $31.25M litigation settlement payment was moved to restricted cash, pressuring liquidity."},"tickerRelevance":{"others":[],"primary":"FLNA"},"globalImportance":25,"audienceRelevance":20,"eventTypeSecondary":["legal_litigation"],"importanceComponents":{"tickerTier":"small-cap","clinicalHold":"bearish","eventGravity":"earnings_with_program_delay","sectorWeight":"Biotech"}},"event_type":"earnings","event_type_secondary":["legal_litigation"],"sentiment":"mixed","material_impact_score":3,"narrative":"Filana Therapeutics reported a narrower net loss of $8.6 million ($0.18 per share) for Q2 2026, compared to a loss of $44.2 million in the prior year, primarily due to the absence of a large litigation charge recorded in 2025.\n\nCash position decreased to $82.7 million from $95.5 million at year-end, with $31.25 million moved to restricted escrow for a potential litigation settlement, leaving estimated unrestricted cash of $36–$40 million by year-end.\n\nThe company continues to engage with the FDA regarding the clinical hold on its simufilam trial for TSC-related epilepsy, with no update on when the hold might be lifted.","key_figures":{"customDimensions":{"net_loss":8600000,"ga_expenses":6100000,"rd_expenses":3300000,"cash_position":82700000,"net_cash_used_operations_h1":12700000,"litigation_settlement_payment":31250000,"projected_unrestricted_cash_year_end":"36 to 40 million"}},"named_entities":{"people":[{"name":"Rick Barry","role":"President and CEO"},{"name":"Eric Schoen","role":"CFO"},{"name":"Mike Moyer","role":"Investor Contact"}],"products":["simufilam"],"companies":[{"name":"Filana Therapeutics, Inc.","ticker":"FLNA"},{"name":"TSC Alliance","relationship":"conference host"},{"name":"Tuberous Sclerosis Complex International","relationship":"conference host"}],"dollarAmounts":[{"amount":"$82.7 million","context":"Cash and cash equivalents at June 30, 2026"},{"amount":"$95.5 million","context":"Cash and cash equivalents at December 31, 2025"},{"amount":"$3.3 million","context":"Q2 2026 R&D expenses"},{"amount":"$6.1 million","context":"Q2 2026 G&A expenses"},{"amount":"$31.25 million","context":"Litigation settlement payment into escrow"},{"amount":"$36 to $40 million","context":"Estimated unrestricted cash at year-end 2026"},{"amount":"$8.6 million","context":"Q2 2026 net loss"},{"amount":"$0.18 per share","context":"Q2 2026 net loss per share"}]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-07-29T15:25:03.902Z","global_importance":25,"audience_relevance":20,"importance_components":{"tickerTier":"small-cap","clinicalHold":"bearish","eventGravity":"earnings_with_program_delay","sectorWeight":"Biotech"}},"durationMs":100516,"modelName":"glm-4.7"}}