Inventiva reports 2025 Third Quarter Financial Information¹




Inventiva reports 2025 Third Quarter Financial Information¹

• Cash and cash equivalents at €97.6 million, and €24.7 million in short-term deposits² as of September 30, 2025.
• Revenues of €4.5 million for the first nine months of 2025.
• Cash runway expected until the end of the first quarter of 2027³, including net proceeds from the November 2025 public offering.

Daix (France), New York City, (New York, United States), November 21, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported its cash position as of September 30, 2025 and its revenues for the first nine months of 2025.

Cash and cash equivalents

As of September 30, 2025, the Company’s cash and cash equivalents amounted to €97.6 million, compared to cash and cash equivalents at €96.6 million as of December 31, 2024.

Net cash used in operating activities amounted to (€76.3) million in the first nine months of 2025, compared to (€63.7) million for the same period in 2024, up by 20%, while R&D expenses for the first nine months of 2025 were slightly lower by 11% at (€64.6) million, compared to the same period of 2024. The increase in net cash used in operating activities is due to working capital evolution and, to a lesser extent, the net cash impact of the implementation of the Company’s previously disclosed pipeline prioritization plan initiated in the first half of 2025.

Net cash used in investing activities for the first nine months of 2025 amounted to (€25.0) million, compared to €8.9 million generated for the same period in 2024. The change is mostly due to the variation in short-term² deposits during the period.

Net cash generated from financing activities for the first nine months of 2025 amounted to €103.4 million, compared to €41.9 million in the same period in 2024. Net cash generated from financing activities during the first nine months of 2025 primarily comes from the receipt of gross proceeds of €115.6 million (net proceeds of €108.0 million) from the settlement in May 2025 of the second tranche⁴ of the structured financing announced by the Company in October 2024 (the “Structured Financing”). Net cash generated from financing activities during the first nine months of 2024 was mainly comprised of (i) the second tranche of €25 million drawn in January 2024 under the unsecured loan agreement granted by the European Investment Bank, and (ii) the issuance of royalty certificates in July 2024 for €20.1 million.

Over the first nine months of 2025, the Company recorded a negative exchange rate effect on cash and cash equivalents of (€1.0) million, compared to none for the same period in 2024, due to the evolution of the EUR/USD exchange rate.

Financial information after closing the accounts

In November 2025, the Company completed a public offering in the United States of 44,805,193 American Depositary Shares (“ADSs”) for aggregate gross proceeds of approximately €149 million (€139.3 million net proceeds)⁵, including the exercise in full of the underwriters’ option to purchase additional ADSs.

Considering its current cost structure and forecasted expenditures, the Company estimates that its cash, cash equivalents and short-term deposits, including the net proceeds from the public offering, should enable it to finance its operations until the end of the first quarter of 2027. Assuming the potential exercise in full of the Tranche 3 warrants issued in the Structured Financing for proceeds of up to €116.0 million, the Company estimates that such potential additional proceeds would enable it to finance its activities until the middle of the third quarter of 2027⁶.

Revenues

Revenues for the first nine months of 2025 amounted to €4.5 million, compared to none generated for the same period in 2024.

Revenues recorded by the Company in the first nine months of 2025 consist mainly of the $10 million gross proceeds (net proceeds of €8.6 million) milestone payment invoiced to Chia Tai Tianqing Pharmaceutical Group (“CTTQ”) and the $5 million (€4.3 million) credit notes recognized under the license agreement with CTTQ following the closing of the second tranche of the Structured Financing in May 2025. The milestone payment from CTTQ was received in July 2025.

          ***

Next key milestones expected

• Topline results of NATiV3 – expected in the second half of 2026

Upcoming shareholders meeting

• Combined General Meeting of Shareholders – November 27, 2025

Upcoming investor conference participation

• Euronext Tech Leaders Forum – November 26, 2025 – Paris
• Piper Sandler 37^th Annual Healthcare Conference – December 2-4, 2025 – New York

Upcoming scientific conference participation

• MASH-TAG – January 7-11, 2026 – Park City

Next financial results publication

• Full-Year 2025 Revenues and cash and cash equivalents: Thursday, February 16, 2026 (after U.S. market close)

About Inventiva

Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease.

Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). http://www.inventivapharma.com  

Contacts

Important Notice

This press release contains certain “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, unaudited financial information, forecasts and estimates with respect to Inventiva’s cash resources, the potential exercise by investors of warrants and pre-funded warrants, including the warrants and pre-funded warrants issued in connection with the Structured Financing, the potential benefit of the pipeline prioritization plan and related workforce reduction, and Inventiva’s future activities, expectations, plans, growth and prospects of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “designed”, “hopefully”, “target”, “potential”, “opportunity”, “possible”, “aim”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva’s control. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due to a number of factors, including that interim data or data from any interim analysis of ongoing clinical trials may not be predictive of future trial results, that the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva’s ability to obtain financing and to enter into potential transactions, on the expected timing or at all, and whether, when and to what extent dilutive instruments may be exercised, and by which holders, Inventiva’s future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva’s and its partners’ clinical trials may not support Inventiva’s and its partners’ product candidate claims, Inventiva’s expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or additional amendments to Inventiva’s clinical trials, Inventiva’s expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva’s ability to identify additional products or product candidates with significant commercial potential, Inventiva’s expectations with respect to its pipeline prioritization plan and related workforce reduction, including potential benefits, expenses and consequences relating thereto, Inventiva’s ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva’s ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva’s and its partners’ control, Inventiva’s product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s business, and pre-clinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, political turmoil, and natural catastrophes, uncertain financial markets and disruptions in banking systems. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. 

Please refer to the Universal Registration Document for the year ended December 31, 2024 filed with the Autorité des Marchés Financiers on April 15, 2025, the interim financial report for the six months ended June 30, 2025 published on September 29, 2025 and the Annual Report on Form 20-F for the year ended December 31, 2024 filed with the Securities and Exchange Commission (the “SEC“) on April 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the caption “Risk Factors”, and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

¹ Non-audited financial information.
² Short-term deposits were included in the category “other current assets” in the IFRS unaudited interim condensed consolidated statement of financial position and were considered by the Company as liquid and easily available.
³ This estimate is based on the Company’s current business plan and excludes any potential milestones payable to or by the Company, any proceeds from the potential exercise of the Tranche 3 warrants issued in the Structured Financing and any additional expenditures related to other product candidates or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based this estimate on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated.
⁴ Press release of May 5, 2025
⁵ Based on the exchange rate of €1.00 = $1.1576 as published by the European Central Bank on November 12, 2025
⁶ These estimates are based on the Company’s current business plan and exclude any potential milestones payable to or by the Company and any additional expenditures related to other product candidates or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated. There can be no assurance whether, and to which extent, the Tranche 3 warrants will be exercised, if at all.

Attachment

• Inventiva – PR – Q3 2025 CA Cash – EN – 11 21 2025

Inventiva reports 2025 Third Quarter Financial Information¹




Inventiva reports 2025 Third Quarter Financial Information¹

• Cash and cash equivalents at €97.6 million, and €24.7 million in short-term deposits² as of September 30, 2025.
• Revenues of €4.5 million for the first nine months of 2025.
• Cash runway expected until the end of the first quarter of 2027³, including net proceeds from the November 2025 public offering.

Daix (France), New York City, (New York, United States), November 21, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported its cash position as of September 30, 2025 and its revenues for the first nine months of 2025.

Cash and cash equivalents

As of September 30, 2025, the Company’s cash and cash equivalents amounted to €97.6 million, compared to cash and cash equivalents at €96.6 million as of December 31, 2024.

Net cash used in operating activities amounted to (€76.3) million in the first nine months of 2025, compared to (€63.7) million for the same period in 2024, up by 20%, while R&D expenses for the first nine months of 2025 were slightly lower by 11% at (€64.6) million, compared to the same period of 2024. The increase in net cash used in operating activities is due to working capital evolution and, to a lesser extent, the net cash impact of the implementation of the Company’s previously disclosed pipeline prioritization plan initiated in the first half of 2025.

Net cash used in investing activities for the first nine months of 2025 amounted to (€25.0) million, compared to €8.9 million generated for the same period in 2024. The change is mostly due to the variation in short-term² deposits during the period.

Net cash generated from financing activities for the first nine months of 2025 amounted to €103.4 million, compared to €41.9 million in the same period in 2024. Net cash generated from financing activities during the first nine months of 2025 primarily comes from the receipt of gross proceeds of €115.6 million (net proceeds of €108.0 million) from the settlement in May 2025 of the second tranche⁴ of the structured financing announced by the Company in October 2024 (the “Structured Financing”). Net cash generated from financing activities during the first nine months of 2024 was mainly comprised of (i) the second tranche of €25 million drawn in January 2024 under the unsecured loan agreement granted by the European Investment Bank, and (ii) the issuance of royalty certificates in July 2024 for €20.1 million.

Over the first nine months of 2025, the Company recorded a negative exchange rate effect on cash and cash equivalents of (€1.0) million, compared to none for the same period in 2024, due to the evolution of the EUR/USD exchange rate.

Financial information after closing the accounts

In November 2025, the Company completed a public offering in the United States of 44,805,193 American Depositary Shares (“ADSs”) for aggregate gross proceeds of approximately €149 million (€139.3 million net proceeds)⁵, including the exercise in full of the underwriters’ option to purchase additional ADSs.

Considering its current cost structure and forecasted expenditures, the Company estimates that its cash, cash equivalents and short-term deposits, including the net proceeds from the public offering, should enable it to finance its operations until the end of the first quarter of 2027. Assuming the potential exercise in full of the Tranche 3 warrants issued in the Structured Financing for proceeds of up to €116.0 million, the Company estimates that such potential additional proceeds would enable it to finance its activities until the middle of the third quarter of 2027⁶.

Revenues

Revenues for the first nine months of 2025 amounted to €4.5 million, compared to none generated for the same period in 2024.

Revenues recorded by the Company in the first nine months of 2025 consist mainly of the $10 million gross proceeds (net proceeds of €8.6 million) milestone payment invoiced to Chia Tai Tianqing Pharmaceutical Group (“CTTQ”) and the $5 million (€4.3 million) credit notes recognized under the license agreement with CTTQ following the closing of the second tranche of the Structured Financing in May 2025. The milestone payment from CTTQ was received in July 2025.

          ***

Next key milestones expected

• Topline results of NATiV3 – expected in the second half of 2026

Upcoming shareholders meeting

• Combined General Meeting of Shareholders – November 27, 2025

Upcoming investor conference participation

• Euronext Tech Leaders Forum – November 26, 2025 – Paris
• Piper Sandler 37^th Annual Healthcare Conference – December 2-4, 2025 – New York

Upcoming scientific conference participation

• MASH-TAG – January 7-11, 2026 – Park City

Next financial results publication

• Full-Year 2025 Revenues and cash and cash equivalents: Thursday, February 16, 2026 (after U.S. market close)

About Inventiva

Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease.

Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). http://www.inventivapharma.com  

Contacts

Important Notice

This press release contains certain “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, unaudited financial information, forecasts and estimates with respect to Inventiva’s cash resources, the potential exercise by investors of warrants and pre-funded warrants, including the warrants and pre-funded warrants issued in connection with the Structured Financing, the potential benefit of the pipeline prioritization plan and related workforce reduction, and Inventiva’s future activities, expectations, plans, growth and prospects of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “designed”, “hopefully”, “target”, “potential”, “opportunity”, “possible”, “aim”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva’s control. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due to a number of factors, including that interim data or data from any interim analysis of ongoing clinical trials may not be predictive of future trial results, that the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva’s ability to obtain financing and to enter into potential transactions, on the expected timing or at all, and whether, when and to what extent dilutive instruments may be exercised, and by which holders, Inventiva’s future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva’s and its partners’ clinical trials may not support Inventiva’s and its partners’ product candidate claims, Inventiva’s expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or additional amendments to Inventiva’s clinical trials, Inventiva’s expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva’s ability to identify additional products or product candidates with significant commercial potential, Inventiva’s expectations with respect to its pipeline prioritization plan and related workforce reduction, including potential benefits, expenses and consequences relating thereto, Inventiva’s ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva’s ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva’s and its partners’ control, Inventiva’s product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s business, and pre-clinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, political turmoil, and natural catastrophes, uncertain financial markets and disruptions in banking systems. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. 

Please refer to the Universal Registration Document for the year ended December 31, 2024 filed with the Autorité des Marchés Financiers on April 15, 2025, the interim financial report for the six months ended June 30, 2025 published on September 29, 2025 and the Annual Report on Form 20-F for the year ended December 31, 2024 filed with the Securities and Exchange Commission (the “SEC“) on April 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the caption “Risk Factors”, and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

¹ Non-audited financial information.
² Short-term deposits were included in the category “other current assets” in the IFRS unaudited interim condensed consolidated statement of financial position and were considered by the Company as liquid and easily available.
³ This estimate is based on the Company’s current business plan and excludes any potential milestones payable to or by the Company, any proceeds from the potential exercise of the Tranche 3 warrants issued in the Structured Financing and any additional expenditures related to other product candidates or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based this estimate on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated.
⁴ Press release of May 5, 2025
⁵ Based on the exchange rate of €1.00 = $1.1576 as published by the European Central Bank on November 12, 2025
⁶ These estimates are based on the Company’s current business plan and exclude any potential milestones payable to or by the Company and any additional expenditures related to other product candidates or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated. There can be no assurance whether, and to which extent, the Tranche 3 warrants will be exercised, if at all.

Attachment

• Inventiva – PR – Q3 2025 CA Cash – EN – 11 21 2025

Scilex Holding Company Announces Update Regarding Distribution of Dream Bowl 2026 Meme Coin by Datavault AI Inc.




Scilex Holding Company Announces Update Regarding Distribution of Dream Bowl 2026 Meme Coin by Datavault AI Inc.

PALO ALTO, Calif., Nov. 21, 2025 (GLOBE NEWSWIRE) — Scilex Holding Company (“Scilex” or the “Company”) (Nasdaq: SCLX), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease, announced today that, with respect to the voluntary distribution by Datavault AI Inc. (“Datavault AI”) (Nasdaq: DVLT) of Dream Bowl 2026 Meme Coins to record holders of Scilex common stock, given that such distribution is being made by Datavault AI as a token of its appreciation for Scilex’s relationship with Datavault AI as a stockholder of Datavault AI, licensing partner and co-sponsor of the Dream Bowl XIV event to be held on January 11, 2026, Nasdaq has informed Datavault AI that it is not planning to make any announcement for Scilex regarding such distribution, whether as to the record date or an ex-dividend date. Notwithstanding the absence of such announcement, Datavault AI has informed the Company that it intends to make such voluntary distribution to record holders of Scilex common stock as of November 25, 2025 concurrently with the distribution of the Dream Bowl 2026 Meme Coins to Datavault AI’s eligible record equity holders, including the Company.

The Dream Bowl 2026 Meme Coins will be airdropped to Data Vault^® wallets following the payment date for the distribution, subject to recipient’s electing to opt-in to the distribution and setting up a digital wallet with Datavault AI and providing Datavault AI with documentation confirming same. Subject to the right of the Board of Directors of Datavault AI to change the record date, the payment date for this distribution will be determined by subsequent resolutions of the Board of Directors of Datavault AI, which will be within 60 days following the record date. Further instructions regarding wallet setup, token access, and distribution procedures will be provided by Datavault AI in a subsequent communication prior to the payment date.

The record date for the distribution may be changed by the Board of Directors of Datavault AI for any reason at any time prior to the actual payment date, and payment of the distribution is conditioned upon the Board not having revoked the dividend prior to the payment date, including for a material change to the solvency or surplus analysis presented to the Board of Directors of Datavault AI. 

For more information on Scilex Holding Company, refer to www.scilexholding.com

For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com

For more information on ZTlido^® including Full Prescribing Information, refer to www.ztlido.com.

For more information on ELYXYB^®, including Full Prescribing Information, refer to www.elyxyb.com.

For more information on Gloperba^®, including Full Prescribing Information, refer to www.gloperba.com.

https://www.facebook.com/scilex.pharm

https://www.linkedin.com/company/scilex-holding-company/

info@scilexholding.com

About Scilex Holding Company

Scilex is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido^® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB^®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba^®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.

In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA” or “SP-102”), which is owned by Semnur (a majority owned subsidiary of Scilex) and is a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia.

Scilex is headquartered in Palo Alto, California.

Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts and may be accompanied by words that convey projected future events or outcomes, such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” or variations of such words or by expressions of similar meaning. These forward-looking statements include, but are not limited to, statements regarding future events, Datavault AI’s potential distribution of the Dream Bowl 2026 Meme Coin and the timing thereof (including that the Board of Directors of Datavault AI may change the record date and, as a result, the payment date thereof), future opportunities for Scilex and its subsidiaries, the future business strategies, long-term objectives and commercialization plans of Scilex and its subsidiaries, the current and prospective product candidates, planned clinical trials and preclinical activities and potential product approvals, as well as the potential for market acceptance of any approved products and the related market opportunity of Scilex and its subsidiaries, statements regarding SP-102, if approved by the FDA, Scilex’s potential to attract new capital and avoid the effects of negative debt leverage and other statements that are not historical facts. These statements are based on management’s current expectations of and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on, by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Scilex. These statements are subject to a number of risks and uncertainties regarding Scilex’s business, and actual results may differ materially. These risks and uncertainties include, but are not limited to, general economic, political and business conditions; risks related to legal proceedings that may be instituted against the parties regarding the Dream Bowl 2026 Meme Coin and the distribution thereof to holders of Scilex common stock; the risks associated with the right of the Board of Directors of Datavault AI to change the record date (and, as a result, the payment date) of the distribution of, and/or to revoke, the Dream Bowl 2026 Meme Coin; the ability of Scilex and its subsidiaries to develop and successfully market products; the ability of Scilex and its subsidiaries to grow and manage growth profitably and retain its key employees; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the prior results of the clinical trials may not be replicated; regulatory and intellectual property risks; the risk of failure to realize the anticipated benefits of the transactions contemplated with Datavault and other risks and uncertainties indicated from time to time and other risks set forth in Scilex’s filings with the SEC. There may be additional risks that Scilex presently does not know or that Scilex currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements provide Scilex’s expectations, plans or forecasts of future events and views as of the date of the communication. Scilex anticipates that subsequent events and developments will cause such assessments to change. However, while Scilex may elect to update these forward-looking statements at some point in the future, Scilex specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Scilex’s assessments as of any date subsequent to the date of this communication. Accordingly, investors are cautioned not to place undue reliance on these forward-looking statements.

Contacts:

Investors and Media
Scilex Holding Company
960 San Antonio Road
Palo Alto, CA 94303
Office: (650) 516-4310

Email: investorrelations@scilexholding.com

Website: www.scilexholding.com

SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a majority-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned.

ZTlido^® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company.

Gloperba^® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company.

ELYXYB^® is a registered trademark owned by Scilex Holding Company.

Scilex Bio™ is a trademark owned by Scilex Holding Company, Inc.

All other trademarks are the property of their respective owners.

© 2025 Scilex Holding Company All Rights Reserved.

Scilex Holding Company Announces Update Regarding Distribution of Dream Bowl 2026 Meme Coin by Datavault AI Inc.




Scilex Holding Company Announces Update Regarding Distribution of Dream Bowl 2026 Meme Coin by Datavault AI Inc.

PALO ALTO, Calif., Nov. 21, 2025 (GLOBE NEWSWIRE) — Scilex Holding Company (“Scilex” or the “Company”) (Nasdaq: SCLX), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease, announced today that, with respect to the voluntary distribution by Datavault AI Inc. (“Datavault AI”) (Nasdaq: DVLT) of Dream Bowl 2026 Meme Coins to record holders of Scilex common stock, given that such distribution is being made by Datavault AI as a token of its appreciation for Scilex’s relationship with Datavault AI as a stockholder of Datavault AI, licensing partner and co-sponsor of the Dream Bowl XIV event to be held on January 11, 2026, Nasdaq has informed Datavault AI that it is not planning to make any announcement for Scilex regarding such distribution, whether as to the record date or an ex-dividend date. Notwithstanding the absence of such announcement, Datavault AI has informed the Company that it intends to make such voluntary distribution to record holders of Scilex common stock as of November 25, 2025 concurrently with the distribution of the Dream Bowl 2026 Meme Coins to Datavault AI’s eligible record equity holders, including the Company.

The Dream Bowl 2026 Meme Coins will be airdropped to Data Vault^® wallets following the payment date for the distribution, subject to recipient’s electing to opt-in to the distribution and setting up a digital wallet with Datavault AI and providing Datavault AI with documentation confirming same. Subject to the right of the Board of Directors of Datavault AI to change the record date, the payment date for this distribution will be determined by subsequent resolutions of the Board of Directors of Datavault AI, which will be within 60 days following the record date. Further instructions regarding wallet setup, token access, and distribution procedures will be provided by Datavault AI in a subsequent communication prior to the payment date.

The record date for the distribution may be changed by the Board of Directors of Datavault AI for any reason at any time prior to the actual payment date, and payment of the distribution is conditioned upon the Board not having revoked the dividend prior to the payment date, including for a material change to the solvency or surplus analysis presented to the Board of Directors of Datavault AI. 

For more information on Scilex Holding Company, refer to www.scilexholding.com

For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com

For more information on ZTlido^® including Full Prescribing Information, refer to www.ztlido.com.

For more information on ELYXYB^®, including Full Prescribing Information, refer to www.elyxyb.com.

For more information on Gloperba^®, including Full Prescribing Information, refer to www.gloperba.com.

https://www.facebook.com/scilex.pharm

https://www.linkedin.com/company/scilex-holding-company/

info@scilexholding.com

About Scilex Holding Company

Scilex is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido^® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB^®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba^®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.

In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA” or “SP-102”), which is owned by Semnur (a majority owned subsidiary of Scilex) and is a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia.

Scilex is headquartered in Palo Alto, California.

Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts and may be accompanied by words that convey projected future events or outcomes, such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” or variations of such words or by expressions of similar meaning. These forward-looking statements include, but are not limited to, statements regarding future events, Datavault AI’s potential distribution of the Dream Bowl 2026 Meme Coin and the timing thereof (including that the Board of Directors of Datavault AI may change the record date and, as a result, the payment date thereof), future opportunities for Scilex and its subsidiaries, the future business strategies, long-term objectives and commercialization plans of Scilex and its subsidiaries, the current and prospective product candidates, planned clinical trials and preclinical activities and potential product approvals, as well as the potential for market acceptance of any approved products and the related market opportunity of Scilex and its subsidiaries, statements regarding SP-102, if approved by the FDA, Scilex’s potential to attract new capital and avoid the effects of negative debt leverage and other statements that are not historical facts. These statements are based on management’s current expectations of and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on, by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Scilex. These statements are subject to a number of risks and uncertainties regarding Scilex’s business, and actual results may differ materially. These risks and uncertainties include, but are not limited to, general economic, political and business conditions; risks related to legal proceedings that may be instituted against the parties regarding the Dream Bowl 2026 Meme Coin and the distribution thereof to holders of Scilex common stock; the risks associated with the right of the Board of Directors of Datavault AI to change the record date (and, as a result, the payment date) of the distribution of, and/or to revoke, the Dream Bowl 2026 Meme Coin; the ability of Scilex and its subsidiaries to develop and successfully market products; the ability of Scilex and its subsidiaries to grow and manage growth profitably and retain its key employees; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the prior results of the clinical trials may not be replicated; regulatory and intellectual property risks; the risk of failure to realize the anticipated benefits of the transactions contemplated with Datavault and other risks and uncertainties indicated from time to time and other risks set forth in Scilex’s filings with the SEC. There may be additional risks that Scilex presently does not know or that Scilex currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements provide Scilex’s expectations, plans or forecasts of future events and views as of the date of the communication. Scilex anticipates that subsequent events and developments will cause such assessments to change. However, while Scilex may elect to update these forward-looking statements at some point in the future, Scilex specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Scilex’s assessments as of any date subsequent to the date of this communication. Accordingly, investors are cautioned not to place undue reliance on these forward-looking statements.

Contacts:

Investors and Media
Scilex Holding Company
960 San Antonio Road
Palo Alto, CA 94303
Office: (650) 516-4310

Email: investorrelations@scilexholding.com

Website: www.scilexholding.com

SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a majority-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned.

ZTlido^® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company.

Gloperba^® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company.

ELYXYB^® is a registered trademark owned by Scilex Holding Company.

Scilex Bio™ is a trademark owned by Scilex Holding Company, Inc.

All other trademarks are the property of their respective owners.

© 2025 Scilex Holding Company All Rights Reserved.

TrialWire’s™ Industry Leading AI-powered Patient Recruitment Platform Delivers Continuous Clinical Trial Referrals over Holiday Season




TrialWire’s™ Industry Leading AI-powered Patient Recruitment Platform Delivers Continuous Clinical Trial Referrals over Holiday Season

SAN FRANCISCO, Nov. 21, 2025 (GLOBE NEWSWIRE) — TrialWire™, the industry’s fastest, advanced AI-powered, algorithm-driven patient recruitment platform, today announced its RapidStart™ and RapidRescue™ solutions are ensuring that biotech-sponsored clinical trials continue enrolling patients without interruption across Thanksgiving and the upcoming holiday season—a period when traditional recruitment often stalls.

As clinical teams prepare for the year-end break, leading sponsors increasingly turn to TrialWire’s™ automated recruitment engine. The platform operates 24/7, pre-qualifying and nurturing trial candidates through intelligent, real-time digital engagement to accelerate enrollment rates and ensure timelines are met regardless of site availability. Recent multi-study data show:

• Studies using TrialWire’s™ automation report a 30–45% increase in eligible referrals compared to conventional outreach in the weeks around major US holidays.
• AI-driven pre-screening reduces manual administrative time by up to 70%, letting sites focus on high-value interactions.
• Platform-triggered SMS engagement delivers a 98% open rate and achieves actionable patient responses within 90 seconds—nearly 60x faster than email or phone outreach—a finding confirmed in 2025 independent surveys.​

“Sponsors see that automated, AI-powered processes not only safeguard enrollment continuity during peak holiday downtime, but deliver better-qualified,motivated ‘trial ready’ referrals—so programs rebound instantly post-holiday,” said Susan Fitzpatrick-Napier, CEO TrialWire™.

As the industry’s fastest AI-powered patient recruitment platform, TrialWire™ can activate within 24 hours and quickly turn around underperforming studies with immediate, compliant recruitment intervention. This cuts timing bottlenecks and ensures recruitment is continually optimized—critical for progressing time-sensitive therapeutics across oncology, rare disease, and high-competition indications.​

By combining predictive analytics, intelligent participant matching, and proactive SMS-based support, TrialWire’s™ end-to-end system maintains participant interest and trust—all while ensuring sites are ready to follow up the moment teams are back online.

Talk to a recruitment expert

About TrialWire™

TrialWire™, the industry’s fastest, advanced AI-powered, algorithm-driven patient recruitment platform, can activate in under 24 hours. TrialWire’s™ solutions including RapidStart™ and RapidRescue™ accelerate enrollment through our award-winning all-in-one platform to quickly reach, engage and pre-screen participants to meet development milestones. Designed for biotech and trial sites the TrialWire™ platform has a track record in accelerating study timelines. Powered by Salesforce Health Cloud and fully HIPAA & GDPR compliant, our system ensures world-class security and data integrity. With locations in San Francisco, Sydney, Singapore, and Paris, TrialWire™ operates globally to deliver rapid recruitment continuity for every client.

CONTACT: Media Contact:
TrialWire PR Team
Team@trial-wire.com
+1 415-951-3228
www.trial-wire.com

TrialWire’s™ Industry Leading AI-powered Patient Recruitment Platform Delivers Continuous Clinical Trial Referrals over Holiday Season




TrialWire’s™ Industry Leading AI-powered Patient Recruitment Platform Delivers Continuous Clinical Trial Referrals over Holiday Season

SAN FRANCISCO, Nov. 21, 2025 (GLOBE NEWSWIRE) — TrialWire™, the industry’s fastest, advanced AI-powered, algorithm-driven patient recruitment platform, today announced its RapidStart™ and RapidRescue™ solutions are ensuring that biotech-sponsored clinical trials continue enrolling patients without interruption across Thanksgiving and the upcoming holiday season—a period when traditional recruitment often stalls.

As clinical teams prepare for the year-end break, leading sponsors increasingly turn to TrialWire’s™ automated recruitment engine. The platform operates 24/7, pre-qualifying and nurturing trial candidates through intelligent, real-time digital engagement to accelerate enrollment rates and ensure timelines are met regardless of site availability. Recent multi-study data show:

• Studies using TrialWire’s™ automation report a 30–45% increase in eligible referrals compared to conventional outreach in the weeks around major US holidays.
• AI-driven pre-screening reduces manual administrative time by up to 70%, letting sites focus on high-value interactions.
• Platform-triggered SMS engagement delivers a 98% open rate and achieves actionable patient responses within 90 seconds—nearly 60x faster than email or phone outreach—a finding confirmed in 2025 independent surveys.​

“Sponsors see that automated, AI-powered processes not only safeguard enrollment continuity during peak holiday downtime, but deliver better-qualified,motivated ‘trial ready’ referrals—so programs rebound instantly post-holiday,” said Susan Fitzpatrick-Napier, CEO TrialWire™.

As the industry’s fastest AI-powered patient recruitment platform, TrialWire™ can activate within 24 hours and quickly turn around underperforming studies with immediate, compliant recruitment intervention. This cuts timing bottlenecks and ensures recruitment is continually optimized—critical for progressing time-sensitive therapeutics across oncology, rare disease, and high-competition indications.​

By combining predictive analytics, intelligent participant matching, and proactive SMS-based support, TrialWire’s™ end-to-end system maintains participant interest and trust—all while ensuring sites are ready to follow up the moment teams are back online.

Talk to a recruitment expert

About TrialWire™

TrialWire™, the industry’s fastest, advanced AI-powered, algorithm-driven patient recruitment platform, can activate in under 24 hours. TrialWire’s™ solutions including RapidStart™ and RapidRescue™ accelerate enrollment through our award-winning all-in-one platform to quickly reach, engage and pre-screen participants to meet development milestones. Designed for biotech and trial sites the TrialWire™ platform has a track record in accelerating study timelines. Powered by Salesforce Health Cloud and fully HIPAA & GDPR compliant, our system ensures world-class security and data integrity. With locations in San Francisco, Sydney, Singapore, and Paris, TrialWire™ operates globally to deliver rapid recruitment continuity for every client.

CONTACT: Media Contact:
TrialWire PR Team
Team@trial-wire.com
+1 415-951-3228
www.trial-wire.com

Brain Injury Association of America Honored Centre for Neuro Skills’ Dr. Mark Ashley as Luminary of the Year




Brain Injury Association of America Honored Centre for Neuro Skills’ Dr. Mark Ashley as Luminary of the Year

BAKERSFIELD, Calif., Nov. 21, 2025 (GLOBE NEWSWIRE) — The Brain Injury Association of America (BIAA) honored Dr. Mark J. Ashley, Founder and Executive Chairman of the Board of Centre for Neuro Skills (CNS), as Luminary of the Year last Friday, November 14, 2025, at the National Press Club in Washington, D.C. The annual award celebrates individuals who have made outstanding contributions to the field of brain injury. The event shines a spotlight on powerful stories of resilience, courage and compassion from the brain injury community.

^{Dr. Mark Ashley holding the Brain Injury Association of America National Luminary of the Year trophy}

“Creating a world with freedom and choices for people affected by brain injury has been my life’s purpose and sole focus for 45 years,” said Dr. Mark Ashley. “BIAA’s tireless advocacy ensures that brain injury survivors will always be seen, heard and prioritized. Their work is crucial to maintaining our collective momentum towards a better future for everyone affected by brain injury.”

^{Rick Willis, President & CEO of the Brain Injury Association of America}

“Dr. Mark Ashley’s contributions to the field of brain injury rehabilitation have been transformative,” said Rick Willis, BIAA’s president and CEO. “Through his decades of leadership, innovation, and unwavering dedication to patient outcomes, he has raised the standard of care and expanded access to life-changing treatment. We are proud to recognize Dr. Ashley as our Luminary of the Year and honor the profound impact he has made on survivors, families and professionals across the country.”

Dr. Ashley founded CNS in 1980 after his brother, Steve, was left completely disabled, suffering from locked-in syndrome—cognitively intact but dependent on a ventilator, unable to move his body, speak or even breathe on his own. Conventional medicine and available rehabilitative therapies gave his brother little hope for significant recovery or regaining his independence. Still, Dr. Ashley believed that Steve could overcome the odds and that rehabilitation was possible through an intense therapy program. His brother became one of CNS’ first patients, and his recovery became the model for the brain injury rehabilitation provider’s philosophy: patients don’t plateau.

^{Dr. Mark Ashley, honored as National Luminary of the Year, joins fellow industry leaders at the Brain Injury Association of America (BIAA) Luminary Event: 
(L–R) Dr. Brent Masel, BIAA National Medical Director; Dr. Gregory O’Shannick, BIAA Medical Director Emeritus; and Joe Richert, former BIAA Board Chair.}

In addition to his work at CNS, Dr. Ashley established the Clinical Research and Education Foundation, a nonprofit research organization that advances public and clinical understanding of brain injury causes and treatment in 2011. He has served on numerous committees and boards for organizations focused on brain injury treatment, research and outcomes. His work has been published in several professional and research publications. Also, he is the author of four books.

At Luminary of the Year gala, attendees and honorees all celebrated Dr. Ashley’s contributions to the field of brain injury and learned about inspiring stories of resolve, determination and compassion from the brain injury community. You can view a video honoring Mark’s career here. The event included a cocktail reception, dinner, auction and Fund the Mission Moment to raise vital funds to directly support the life-changing work of BIAA.

^{Congratulatory poster of Dr. Mark Ashley}

About Brain Injury Association of America
The Brain Injury Association of America is the country’s oldest and largest nationwide brain injury advocacy organization. BIAA’s mission is to improve the quality of life of people affected by brain injury across their lifespan through advancing prevention, awareness, research, treatment, education, and advocacy. BIAA is dedicated to increasing access to quality health care and raising awareness and understanding of brain injury.

Find more information online at our website or follow us on social media.
https://www.biausa.org  
https://www.facebook.com/BrainInjuryAssociationofAmerica/  
https://www.instagram.com/bia_usa/  
https://www.linkedin.com/company/brain-injury-association-of-america  
https://x.com/biaamerica  

About Centre for Neuro Skills 
Centre for Neuro Skills is an experienced and respected world leader in providing intensive rehabilitation and medical programs for those recovering from all types of brain injury. Recognized as one of America’s Greatest Midsize Workplaces 2025 by Newsweek, CNS covers a full spectrum of advanced care from residential and assisted living to outpatient/day treatment. Founded by Dr. Mark Ashley in 1980, CNS has seven locations in California and Texas. For more information about Centre for Neuro Skills visit neuroskills.com, Facebook, X, LinkedIn, YouTube. For a video overview of CNS, visit our YouTube channel. 

Media, please note: To request an interview with CNS leadership or clinical staff, please contact Cheryl Reiss at 415.640.5431 or CNS@landispr.com.

Media Contacts:

Centre for Neuro Skills
Cheryl Reiss
415.640.5431
CNS@landispr.com

Brain Injury Association of America
Steve Walsh
(703) 761-0750 ext. 643
swalsh@biausa.org

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/7a59df8c-b31e-4c2b-8273-bde8b735fae3

https://www.globenewswire.com/NewsRoom/AttachmentNg/a3ee2aa0-6e60-427f-adc7-f994b9206e24

https://www.globenewswire.com/NewsRoom/AttachmentNg/69ba5fff-3fe2-4192-843a-c4f2af3d73e1

https://www.globenewswire.com/NewsRoom/AttachmentNg/d68cb355-c8c8-443d-a418-0c8a80d536e9

A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ada47992-e341-439a-8eee-6cfe830de99b

Brain Injury Association of America Honored Centre for Neuro Skills’ Dr. Mark Ashley as Luminary of the Year




Brain Injury Association of America Honored Centre for Neuro Skills’ Dr. Mark Ashley as Luminary of the Year

BAKERSFIELD, Calif., Nov. 21, 2025 (GLOBE NEWSWIRE) — The Brain Injury Association of America (BIAA) honored Dr. Mark J. Ashley, Founder and Executive Chairman of the Board of Centre for Neuro Skills (CNS), as Luminary of the Year last Friday, November 14, 2025, at the National Press Club in Washington, D.C. The annual award celebrates individuals who have made outstanding contributions to the field of brain injury. The event shines a spotlight on powerful stories of resilience, courage and compassion from the brain injury community.

^{Dr. Mark Ashley holding the Brain Injury Association of America National Luminary of the Year trophy}

“Creating a world with freedom and choices for people affected by brain injury has been my life’s purpose and sole focus for 45 years,” said Dr. Mark Ashley. “BIAA’s tireless advocacy ensures that brain injury survivors will always be seen, heard and prioritized. Their work is crucial to maintaining our collective momentum towards a better future for everyone affected by brain injury.”

^{Rick Willis, President & CEO of the Brain Injury Association of America}

“Dr. Mark Ashley’s contributions to the field of brain injury rehabilitation have been transformative,” said Rick Willis, BIAA’s president and CEO. “Through his decades of leadership, innovation, and unwavering dedication to patient outcomes, he has raised the standard of care and expanded access to life-changing treatment. We are proud to recognize Dr. Ashley as our Luminary of the Year and honor the profound impact he has made on survivors, families and professionals across the country.”

Dr. Ashley founded CNS in 1980 after his brother, Steve, was left completely disabled, suffering from locked-in syndrome—cognitively intact but dependent on a ventilator, unable to move his body, speak or even breathe on his own. Conventional medicine and available rehabilitative therapies gave his brother little hope for significant recovery or regaining his independence. Still, Dr. Ashley believed that Steve could overcome the odds and that rehabilitation was possible through an intense therapy program. His brother became one of CNS’ first patients, and his recovery became the model for the brain injury rehabilitation provider’s philosophy: patients don’t plateau.

^{Dr. Mark Ashley, honored as National Luminary of the Year, joins fellow industry leaders at the Brain Injury Association of America (BIAA) Luminary Event: 
(L–R) Dr. Brent Masel, BIAA National Medical Director; Dr. Gregory O’Shannick, BIAA Medical Director Emeritus; and Joe Richert, former BIAA Board Chair.}

In addition to his work at CNS, Dr. Ashley established the Clinical Research and Education Foundation, a nonprofit research organization that advances public and clinical understanding of brain injury causes and treatment in 2011. He has served on numerous committees and boards for organizations focused on brain injury treatment, research and outcomes. His work has been published in several professional and research publications. Also, he is the author of four books.

At Luminary of the Year gala, attendees and honorees all celebrated Dr. Ashley’s contributions to the field of brain injury and learned about inspiring stories of resolve, determination and compassion from the brain injury community. You can view a video honoring Mark’s career here. The event included a cocktail reception, dinner, auction and Fund the Mission Moment to raise vital funds to directly support the life-changing work of BIAA.

^{Congratulatory poster of Dr. Mark Ashley}

About Brain Injury Association of America
The Brain Injury Association of America is the country’s oldest and largest nationwide brain injury advocacy organization. BIAA’s mission is to improve the quality of life of people affected by brain injury across their lifespan through advancing prevention, awareness, research, treatment, education, and advocacy. BIAA is dedicated to increasing access to quality health care and raising awareness and understanding of brain injury.

Find more information online at our website or follow us on social media.
https://www.biausa.org  
https://www.facebook.com/BrainInjuryAssociationofAmerica/  
https://www.instagram.com/bia_usa/  
https://www.linkedin.com/company/brain-injury-association-of-america  
https://x.com/biaamerica  

About Centre for Neuro Skills 
Centre for Neuro Skills is an experienced and respected world leader in providing intensive rehabilitation and medical programs for those recovering from all types of brain injury. Recognized as one of America’s Greatest Midsize Workplaces 2025 by Newsweek, CNS covers a full spectrum of advanced care from residential and assisted living to outpatient/day treatment. Founded by Dr. Mark Ashley in 1980, CNS has seven locations in California and Texas. For more information about Centre for Neuro Skills visit neuroskills.com, Facebook, X, LinkedIn, YouTube. For a video overview of CNS, visit our YouTube channel. 

Media, please note: To request an interview with CNS leadership or clinical staff, please contact Cheryl Reiss at 415.640.5431 or CNS@landispr.com.

Media Contacts:

Centre for Neuro Skills
Cheryl Reiss
415.640.5431
CNS@landispr.com

Brain Injury Association of America
Steve Walsh
(703) 761-0750 ext. 643
swalsh@biausa.org

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/7a59df8c-b31e-4c2b-8273-bde8b735fae3

https://www.globenewswire.com/NewsRoom/AttachmentNg/a3ee2aa0-6e60-427f-adc7-f994b9206e24

https://www.globenewswire.com/NewsRoom/AttachmentNg/69ba5fff-3fe2-4192-843a-c4f2af3d73e1

https://www.globenewswire.com/NewsRoom/AttachmentNg/d68cb355-c8c8-443d-a418-0c8a80d536e9

A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ada47992-e341-439a-8eee-6cfe830de99b

Pasithea Therapeutics Announces Positive PAS-004 Tablet Pharmacokinetic (PK) Data in Ongoing Phase 1/1b Trial in Adult NF1 Patients




Pasithea Therapeutics Announces Positive PAS-004 Tablet Pharmacokinetic (PK) Data in Ongoing Phase 1/1b Trial in Adult NF1 Patients

— Tablet PK exposure increases proportionally with an increase in dose —

— More favorable PK properties in tablets enable a lower dose to achieve the same exposure as the capsule formulation, with improved predictability and reduced variability —

— Tablet steady state showing Cmax/Cmin ratio <2 —

MIAMI, Nov. 21, 2025 (GLOBE NEWSWIRE) — Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), today announced positive tablet PK data from ongoing Phase 1/1b open-label study evaluating PAS-004 in adult patients with neurofibromatosis type 1 (NF1) with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas (NCT06961565).

Pharmacokinetics (PK)

PAS-004 has demonstrated in the tablet formulation (4mg and 8mg cohorts):

• Linear PK and dose-proportionality
• PK curve with Cmax/Cmin ratio <2, with Cmax and Cmin above the IC50 (half-maximal inhibitory concentration) from our cellular assay
• Long half-life (~57 hours)
  
• Cohort 1 (4mg tablet) has demonstrated:
  • AUC: 1,120 ng·h/mL
  • Cmax: 58.1 ng/mL

    Cmin: 37.6 ng/mL

• Cohort 2 (8mg tablet) has demonstrated:
  • AUC: 2,290 ng·h/mL
  • Cmax: 118 ng/mL
  • Cmin: 75.4 ng/mL

Dose normalized exposures following once daily administration of PAS-004 tablets were approximately 3-fold higher than those following administration with the capsule formulation, resulting in the 8mg tablet area under the curve (AUC) and Cmax being slightly greater than those of the 22mg capsule. The tablet formulation has demonstrated less patient variability and a similar Tmax range when compared to the capsule formulation. This is consistent with the pre-clinical evaluation of the two formulations in the dog toxicology studies.

Graph 1 below represents the tablet PK curve at steady state for the 4mg and 8mg doses and Graph 2 below represents the 8mg tablet PK curve at steady state as compared to 22mg capsule dose at steady state from our ongoing Phase 1 trial in advanced cancer patients:

Graph 1:

Graph 2:

About Pasithea Therapeutics Corp.

Pasithea is a clinical-stage biotechnology company primarily focused on the research and development of its lead drug candidate, PAS-004, a next-generation macrocyclic MEK inhibitor intended for the treatment of RASopathies, MAPK pathway-driven tumors, and other diseases. The Company is currently testing PAS-004 in a Phase 1 clinical trial in advanced cancer patients (NCT06299839), and a Phase 1/1b clinical trial in adult patients with neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas (NCT06961565).

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the Company’s ongoing Phase 1 clinical trial of PAS-004 in advanced cancer patients, the Company’s ongoing Phase 1/1b clinical trial of PAS-004 in adult NF1 patients, and the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD) and preliminary efficacy of PAS-004, as well as all other statements, other than statements of historical fact, regarding the Company’s current views and assumptions with respect to future events regarding its business, as well as other statements with respect to the Company’s plans, assumptions, expectations, beliefs and objectives, the success of the Company’s current and future business strategies, product development, pre-clinical studies, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth and financing opportunities and other statements that are predictive in nature. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including risks that future clinical trial results may not match results observed to date, may be negative or ambiguous, or may not reach the level of statistical significance required for regulatory approval, as well as other factors set forth in the Company’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings made with the U.S. Securities and Exchange Commission. Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.

Pasithea Therapeutics Contact

Patrick Gaynes
Corporate Communications
pgaynes@pasithea.com

Graphs accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/456983e6-8204-4553-b5a5-972eabc348d5

https://www.globenewswire.com/NewsRoom/AttachmentNg/ed3ed272-0b62-4549-8ada-a84eedc6ce66