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NervGenF
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-13
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Investor releaseQuarter not tagged2026-08-13

NervGen Reports Second Quarter 2026 Financial Results and Provides Business Updates

GlobeNewswire
Site activation and screening for the Phase 3 RESTORE study is expected to begin in September 2026, with the first participant anticipated to be dosed shortly thereafter. Strengthened leadership team, appointing Keith Vendola, MD, MBA as Chief Financial Officer and Marissa Volpe as SVP, Clinical Development. C$86.8 million (US$61.1 million) in cash and cash equivalents as of June 30, 2026, which is expected to fund operations through anticipated topline data readout from RESTORE in 1H 2028. Company plans to host inaugural R&D Day in Fall 2026, bringing together members of NervGen’s management team and leading SCI experts. VANCOUVER, British Columbia, Aug. 13, 2026 (GLOBE NEWSWIRE) -- NervGen (NASDAQ: NGEN), a late-stage clinical biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions, today reported financial results for the second quarter ended June 30, 2026, and provided business updates. “With FDA alignment and funding to support RESTORE now in place, we have expanded our organization with experienced professionals who understand the operational demands of late-stage clinical development and have the experience and judgement required to execute successfully. We are now advancing a coordinated site activation strategy and preparing to begin screening and enrollment across multiple centers,” said Adam Rogers, MD, President and Chief Executive Officer of NervGen. “For the SCI community, RESTORE represents a rare and important registrational study of a pharmacologic candidate in individuals living with chronic SCI. September also marks SCI Awareness Month and will include an externally led Patient-Focused Drug Development meeting, providing a notable forum to elevate the perspectives and priorities of individuals living with SCI.” Second Quarter 2026 and Other Recent Highlights Expanded the organization with key leadership and operational hires; site activation and screening for the Phase 3 RESTORE study is expected to begin in September 2026, with the first participant anticipated to be dosed shortly thereafter. Achieved alignment with the FDA on the clinical trial design of RESTORE, a Phase 3 registrational study of NVG-291 in individuals with chronic SCI. Announced positive results from independent, blinded biomechanical gait analyses from CONNECT SCI,…Read full document

Site activation and screening for the Phase 3 RESTORE study is expected to begin in September 2026, with the first participant anticipated to be dosed shortly thereafter. Strengthened leadership team, appointing Keith Vendola, MD, MBA as Chief Financial Officer and Marissa Volpe as SVP, Clinical Development. C$86.8 million (US$61.1 million) in cash and cash equivalents as of June 30, 2026, which is expected to fund operations through anticipated topline data readout from RESTORE in 1H 2028. Company plans to host inaugural R&D Day in Fall 2026, bringing together members of NervGen’s management team and leading SCI experts. VANCOUVER, British Columbia, Aug. 13, 2026 (GLOBE NEWSWIRE) -- NervGen (NASDAQ: NGEN), a late-stage clinical biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions, today reported financial results for the second quarter ended June 30, 2026, and provided business updates. “With FDA alignment and funding to support RESTORE now in place, we have expanded our organization with experienced professionals who understand the operational demands of late-stage clinical development and have the experience and judgement required to execute successfully. We are now advancing a coordinated site activation strategy and preparing to begin screening and enrollment across multiple centers,” said Adam Rogers, MD, President and Chief Executive Officer of NervGen. “For the SCI community, RESTORE represents a rare and important registrational study of a pharmacologic candidate in individuals living with chronic SCI. September also marks SCI Awareness Month and will include an externally led Patient-Focused Drug Development meeting, providing a notable forum to elevate the perspectives and priorities of individuals living with SCI.” Second Quarter 2026 and Other Recent Highlights Expanded the organization with key leadership and operational hires; site activation and screening for the Phase 3 RESTORE study is expected to begin in September 2026, with the first participant anticipated to be dosed shortly thereafter. Achieved alignment with the FDA on the clinical trial design of RESTORE, a Phase 3 registrational study of NVG-291 in individuals with chronic SCI. Announced positive results from independent, blinded biomechanical gait analyses from CONNECT SCI, demonstrating statistically significant improvement in gait quality across established hallmarks of SCI-specific recovery: coordination, mechanical effort, and postural stability. Completed a US$60.0 million underwritten public offering with participation from leading institutional healthcare investors, strengthening the Company’s balance sheet and extending its expected operating runway through anticipated topline data readout from RESTORE in 1H 2028. Phase 3 RESTORE Study Update In April 2026, NervGen announced alignment with the FDA on the clinical trial design of RESTORE, the Company’s Phase 3 registrational study of NVG-291 in individuals with chronic SCI. Since then, NervGen has expanded its clinical development and operations team and has completed several key start-up activities, including finalizing site selection which has prioritized neurorehabilitation hospitals and clinics in the United States and Canada that specialize in the treatment of individuals with SCI. NervGen is advancing a coordinated site activation strategy for RESTORE and expects to begin screening in September 2026, with the first participant anticipated to be dosed shortly thereafter. Additional sites are expected to be activated on a rolling basis. The Company continues to expect completion of enrollment in 2H 2027, with anticipated topline data readout in 1H 2028. Upcoming Company and Related Events SCI Patient-Focused Drug Development (PFDD) Meeting — September 29, 2026. An externally led PFDD meeting concerning SCI is scheduled to be held virtually from 10:00 a.m. to 3:00 p.m. ET. Registration and additional information are available at www.scipfdd.org/register. Inaugural R&D Day — Fall 2026. NervGen plans to host its inaugural R&D Day featuring members of the Company’s management team and leading SCI experts. The event will highlight the biological rationale supporting NVG-291 as a neuroreparative therapeutic candidate, clinical data generated to date, the Phase 3 RESTORE study and the Company’s broader clinical development strategy. Additional details, including the date, time, agenda, participating experts and webcast information, will be provided in a separate announcement. Second Quarter 2026 Financial Results Cash and Investments. As of June 30, 2026, NervGen had cash and cash equivalents of C$86.8 million (US$61.1 million), compared to C$22.1 million (US$16.1 million) as of December 31, 2025. Based on its current operating plan, the Company believes that its cash and cash equivalents as of June 30, 2026, will be sufficient to fund its operations through the anticipated topline data readout from RESTORE in 1H 2028. Subsequent to quarter-end, on July 2, 2026, the Company established a new at-the-market (ATM) facility with Leerink Partners LLC, under which the Company may offer and sell common shares having an aggregate offering price of up to US$50.0 million. Through the date of this release, no common shares have been sold under the ATM program. Research & Development (R&D). R&D expenses were C$7.9 million for the three months ended June 30, 2026, compared to C$2.7 million for the same period in 2025. The increase was primarily attributable to RESTORE study start-up costs, clinical manufacturing, and preclinical embryofetal and chronic toxicology studies. General and Administrative (G&A). G&A expenses were C$4.3 million for the three months ended June 30, 2026, compared to C$3.8 million for the same period in 2025. The increase was primarily attributable to an increase in non-cash stock-based compensation expense due to additions to the leadership team, and higher insurance premiums as a result of the Company’s listing on Nasdaq. Net Loss. Net loss for the three months ended June 30, 2026, was C$29.2 million, or C$0.32 per weighted-average common share outstanding (basic) and C$0.37 per weighted-average common share outstanding (diluted), compared to a net loss of C$9.1 million, or C$0.13 per weighted-average common share outstanding (basic and diluted), for the same period in 2025. Net loss for the period includes a C$19.4 million non-cash unrealized loss on the warrant derivatives compared to C$2.7 million non-cash unrealized loss on the warrant derivative, for the same period in 2025. The warrant derivative is remeasured each period and is not indicative of the Company’s operating performance or cash requirements. The Company’s financial statements for the quarter ended June 30, 2026, and the related management’s discussion and analysis (MD&A) will be available on SEDAR+ at www.sedar.com and on EDGAR at www.sec.gov/edgar. About the Phase 3 RESTORE StudyRESTORE is a randomized, double-blind, placebo-controlled Phase 3 study of NVG-291 in approximately 150 adults aged 18 to 75 with chronic cervical SCI (neurological level of injury at or above C7; ASIA Impairment Scale C or D), one to ten years post-injury. Participants will receive 12 weeks of once-daily subcutaneous NVG-291 or placebo, followed by a four-week observational period, with an optional 12-week open-label extension. The primary endpoint is the change from baseline to Week 12 in the GRASSP Quantitative Prehension assessment of fine-motor hand function. Key secondary endpoints include the Patient and Clinician Global Impression of Change, the Spinal Cord Independence Measure Version III, and the Modified Ashworth Scale for spasticity. A blinded qualitative interview will also assess participants’ lived experience during RESTORE and contextualize clinically meaningful change. About NervGenNervGen (NASDAQ: NGEN) is a late-stage clinical biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions. The Company’s mission is to transform the lives of individuals living with SCI by enabling the nervous system to repair itself. NervGen’s lead therapeutic candidate, NVG-291, is a subcutaneously administered, neuroreparative peptide designed to target the inhibitory CSPG-PTPσ pathway. NVG-291 is the first pharmacologic candidate to improve function, independence, and quality of life in chronic SCI, as observed in the Phase 1b/2a CONNECT SCI study. NVG-291 has received Fast Track designation from the FDA and Orphan Drug designation from the European Medicines Agency for the treatment of SCI. Through NVG-291 and the Company’s next-generation candidate, NVG-300, NervGen is pursuing a pharmacologic approach to transform the treatment paradigm for neurotraumatic and neurologic conditions with significant unmet medical need. For more information, visit www.nervgen.com and follow NervGen on X and LinkedIn. Cautionary Note Regarding Forward-Looking Statements This news release may contain "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws (collectively, "forward-looking statements"). Such forward-looking statements include, but are not limited to, statements regarding the Company's current and future plans, expectations and intentions; results; levels of activity; performance; goals or achievements; and other future events or developments constitute forward-looking statements, and the words "may", "will", "would", "should", "could", "expect", "plan", "intend", "trend", "indication", "anticipate", "believe", "estimate", "predict", "likely" or "potential", or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements include, without limitation, statements relating to: the timing and status of the Company’s initiation of the RESTORE registrational study in chronic SCI; the sufficiency of the Company’s cash resources and the period into which they are expected to fund operations; the Company’s planned R&D Day and the content thereof; the expected timing of the Company’s indication prioritization framework; the Company's ability to develop and commercialize NVG-291 for chronic SCI; the potential broad therapeutic applications of NVG-291 and NVG-300; and ability of the Company to develop neuroreparative therapeutics to enable the nervous system to repair itself in settings of neurotrauma and neurologic disease. Forward-looking statements are based on estimates and assumptions made by the Company in light of management's experience and perception of historical trends, current conditions and expected future developments, as well as other factors that management believes are appropriate and reasonable in the circumstances. In making forward-looking statements, the Company has relied on various assumptions, including, but not limited to: its ability to obtain future funding on favorable terms, if at all; the accuracy of its financial projections; obtaining positive results in its clinical trials; its ability to obtain necessary regulatory approvals; its ability to arrange for the manufacturing of its product candidates and technologies; and general business, market and economic conditions. Numerous factors could cause the Company's actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements, including without limitation, insufficient funding, reliance upon key personnel, the uncertainty of the clinical development process, competition, and other factors set forth in the “Risk Factors” section of the Company's most recently filed Annual Information Form, which is available under the Company’s profile on SEDAR+ at www.sedarplus.ca (which are also incorporated in the filed Form 40-F available on the website of the U.S. Securities and Exchange Commission (the “SEC”) at www.sec.gov), including the management’s discussion and analysis for the year ended December 31, 2025. All clinical development plans are subject to additional funding. Readers should not place undue reliance on forward-looking statements made in this news release. Furthermore, unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement. ContactsOn365 Partners, Investor [email protected] 203.293.8091 David Schull or Ignacio Guerrero-Ros, Ph.D., MediaRusso [email protected]@russopartnersllc.com 858.717.2310

Investor releaseQuarter not tagged2026-05-18

NervGen Reports First Quarter 2026 Financial Results and Provides Business Updates

GlobeNewswire
Completed successful FDA End-of-Phase 2 meeting, reaching alignment on the study parameters of RESTORE, a registrational study of NVG-291 in chronic tetraplegia, with site activation underway and study initiation on track for mid-2026.  Independent, blinded biomechanical gait analyses of the CONNECT SCI study designed to differentiate genuine neural recovery from compensatory movement remain ongoing, with results anticipated in 2Q 2026. Successfully listed on Nasdaq under the symbol 'NGEN' on January 8, 2026, and voluntarily delisted from the TSX Venture Exchange. Strengthened leadership team with three senior appointments to support late-stage clinical development and Nasdaq listing. VANCOUVER, British Columbia, May 18, 2026 (GLOBE NEWSWIRE) -- NervGen Pharma Corp. (“NervGen” or the “Company") (NASDAQ: NGEN), a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions, today reported financial results for the first quarter ended March 31, 2026, and provided business updates. "With the achievement of FDA alignment on the study parameters of RESTORE, our registrational study of NVG-291 in chronic tetraplegia, NervGen is now firmly in execution mode," said Adam Rogers, MD, President and Chief Executive Officer of NervGen. "Our focus is on initiating the registrational study in mid-2026, advancing forward on behalf of the individuals living with SCI who today have no pharmacologic options capable of enabling meaningful recovery of function, independence, or quality of life. The progress we are making, including activating study sites and expanding our senior leadership team, reflect the necessary steps to advance a therapy of this magnitude toward potential approval." Business HighlightsNVG-291 in Chronic Tetraplegia RESTORE Registrational Study Progress NervGen completed a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), reaching alignment on the study parameters of RESTORE, a registrational study evaluating NVG-291 in chronic tetraplegia. The RESTORE study is on track for initiation in mid-2026, with site activation underway. CONNECT SCI Biomechanical Gait Analyses Independent, blinded biomechanical gait analyses of the Phase 1b/2a CONNECT SCI study remain ongoing, conducted by a specialized mov…Read full document

Completed successful FDA End-of-Phase 2 meeting, reaching alignment on the study parameters of RESTORE, a registrational study of NVG-291 in chronic tetraplegia, with site activation underway and study initiation on track for mid-2026.  Independent, blinded biomechanical gait analyses of the CONNECT SCI study designed to differentiate genuine neural recovery from compensatory movement remain ongoing, with results anticipated in 2Q 2026. Successfully listed on Nasdaq under the symbol 'NGEN' on January 8, 2026, and voluntarily delisted from the TSX Venture Exchange. Strengthened leadership team with three senior appointments to support late-stage clinical development and Nasdaq listing. VANCOUVER, British Columbia, May 18, 2026 (GLOBE NEWSWIRE) -- NervGen Pharma Corp. (“NervGen” or the “Company") (NASDAQ: NGEN), a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions, today reported financial results for the first quarter ended March 31, 2026, and provided business updates. "With the achievement of FDA alignment on the study parameters of RESTORE, our registrational study of NVG-291 in chronic tetraplegia, NervGen is now firmly in execution mode," said Adam Rogers, MD, President and Chief Executive Officer of NervGen. "Our focus is on initiating the registrational study in mid-2026, advancing forward on behalf of the individuals living with SCI who today have no pharmacologic options capable of enabling meaningful recovery of function, independence, or quality of life. The progress we are making, including activating study sites and expanding our senior leadership team, reflect the necessary steps to advance a therapy of this magnitude toward potential approval." Business HighlightsNVG-291 in Chronic Tetraplegia RESTORE Registrational Study Progress NervGen completed a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), reaching alignment on the study parameters of RESTORE, a registrational study evaluating NVG-291 in chronic tetraplegia. The RESTORE study is on track for initiation in mid-2026, with site activation underway. CONNECT SCI Biomechanical Gait Analyses Independent, blinded biomechanical gait analyses of the Phase 1b/2a CONNECT SCI study remain ongoing, conducted by a specialized movement intelligence company. The analyses are designed to objectively differentiate genuine neural recovery from compensatory movement by evaluating established recovery hallmarks: coordination, mechanical effort, and postural stability. The Company continues to anticipate presenting results from these analyses in 2Q 2026. Pipeline Expansion NervGen continues to advance its strategy to expand NVG-291 into additional, complementary clinical indications as informed by preclinical evidence supporting potential efficacy across neurotraumatic and neurologic conditions. The Company continues to expect to communicate its indication prioritization framework, supported by biological rationale, in mid-2026. The framework is intended to inform the initiation of clinical development activities in the selected indications. Senior Leadership Additions During the First Quarter 2026NervGen strengthened its leadership team with three senior appointments to support late-stage clinical development and its Nasdaq listing. Keith Vendola, MD, MBA, Chief Financial Officer: Dr. Vendola brings more than 30 years of healthcare corporate finance experience. He most recently served as Chief Financial Officer of Wugen, a clinical-stage cell therapy company. Prior to Wugen, he was Chief Financial Officer of IO Biotech, leading the company through its initial public offering. Earlier in his career, he served as Chief Financial Officer and Chief Strategy Officer of Rezolute, where he led the company through financial transformation and its Nasdaq listing, as well as Chief of Staff to the Chief Executive Officer and Vice President of Competitive Strategy and Investor Relations at Coherus BioSciences, where his responsibilities spanned corporate development, strategy, operations, and investor relations. Shamim Ruff, Chief Regulatory Affairs Officer: Ms. Ruff brings more than 30 years of strategic leadership in regulatory affairs. Most recently, Ms. Ruff served as Chief Regulatory Affairs Officer and Senior Vice President, Head of Quality Assurance at Stoke Therapeutics, leading regulatory strategy for the company's RNA medicine platform. Prior to Stoke, Ms. Ruff served as Chief Regulatory Affairs Officer at Sarepta Therapeutics, where she built the company's regulatory affairs and quality organizations and led regulatory strategy for its rare and infectious disease pipelines. She also served as Chair of the Development Advisory Board and Strategic Regulatory Advisor to the Chief Executive Officer and New Drug Application Submissions Team at Soleno Therapeutics and on the Board of Directors of Reata Pharmaceuticals until its acquisition by Biogen. Christine McSherry, Senior Vice President, Patient Advocacy & Clinical Affairs: Ms. McSherry brings more than 30 years of experience bridging patient advocacy and clinical development. Most recently, Ms. McSherry co-founded Casimir, a clinical research organization that worked across more than 20 rare diseases, capturing and quantifying patient and caregiver perception of treatment benefit. Casimir's work pioneered the development of outcome measures to advance the FDA's patient-focused drug development initiative. Ms. McSherry served as Chief Executive Officer of Casimir until its acquisition by Emmes. In 2001, she founded the Jett Foundation following the diagnosis of her son, Jett, with Duchenne muscular dystrophy (DMD). The Foundation became a leading voice for affected families and played a central role in the advocacy efforts that contributed to the FDA's approval of Sarepta’s Exondys 51, the first approved therapy for DMD. Ms. McSherry continues to serve as a Director of the Jett Foundation and previously served on the Board of Directors of the Duchenne Alliance. Additional Corporate Updates NervGen successfully listed on Nasdaq under the symbol 'NGEN' on January 8, 2026, and voluntarily delisted its common shares from the TSX Venture Exchange in March 2026. First Quarter 2026 Financial ResultsCash and Investments. As of March 31, 2026, NervGen had cash and investments of $16.6 million. Research & Development (R&D). R&D expenses were $4.9 million for the three months ended March 31, 2026, compared to $3.1 million for the same period in 2025. General and Administrative (G&A). G&A expenses were $2.7 million for the three months ended March 31, 2026, compared to $2.9 million for the same period in 2025. Net Loss. Net loss for the three months ended March 31, 2026 was $1.7 million, or $0.02 per weighted-average common share outstanding (basic) and $0.09 per weighted-average common share outstanding (diluted), compared to a net loss of $3.9 million, or $0.06 per weighted-average common share outstanding (basic and diluted), for the same period in 2025. The reduction in net loss reflects a $5.7 million non-cash unrealized gain on the warrant derivative recorded during the period, compared to a $2.0 million non-cash unrealized gain for the same period in 2025, partially offset by higher operating expenses associated with preparation for the RESTORE registrational study. About NervGen PharmaNervGen Pharma Corp. (NASDAQ: NGEN) is a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions. The Company’s mission is to transform the lives of individuals living with SCI by enabling the nervous system to repair itself. NervGen’s lead therapeutic candidate, NVG-291, is a subcutaneously administered, neuroreparative peptide designed to target the inhibitory CSPG-PTPσ pathway. NVG-291 is the first pharmacologic candidate to improve function, independence, and quality of life in chronic tetraplegia, as demonstrated in the Phase 1b/2a CONNECT SCI study. NVG-291 has received Fast Track designation from the FDA and Orphan Drug designation from the European Medicines Agency for the treatment of SCI. Through NVG-291 and the Company’s next-generation candidate, NVG-300, NervGen is pursuing a pharmacologic approach to transform the treatment paradigm for neurotraumatic and neurologic conditions with significant unmet medical need. For more information, visit www.nervgen.com and follow NervGen on X and LinkedIn. Cautionary Note Regarding Forward Looking Statements This news release may contain "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws (collectively, "forward-looking statements"). Such forward-looking statements herein include but are not limited to, the Company's current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or any other future events or developments constitute forward-looking statements, and the words "may", "will", "would", "should", "could", "expect", "plan", "intend", "trend", "indication", "anticipate", "believe", "estimate", "predict", "likely" or "potential", or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements include, without limitation, statements relating to: the timing and status of the Company's initiation of the RESTORE registrational study in chronic tetraplegia, including site activation; the timing of the presentation of results from the independent, blinded biomechanical gait analyses of the CONNECT SCI Phase 1b/2a study; the Company's ability to distinguish genuine neural recovery from compensatory movement through such biomechanical analyses; the Company's plans to expand NVG-291 into additional, complementary clinical indications; the timing of communication of the Company's indication prioritization framework and the initiation of clinical development activities in selected indications; the Company's continued advancement of late-stage clinical development; the Company's potentially first-in-class candidate, NVG-291; the potential broad therapeutic applications of NVG-291; NVG-291 as potentially the first approved pharmacologic treatment for chronic tetraplegia; and the creation of neuroreparative therapeutics to enable the nervous system to repair itself in settings of neurotrauma and neurologic disease. Forward-looking statements are based on estimates and assumptions made by the Company in light of management's experience and perception of historical trends, current conditions and expected future developments, as well as other factors that we believe are appropriate and reasonable in the circumstances. In making forward-looking statements, the Company has relied on various assumptions, including, but not limited to: its ability to obtain future funding on favorable terms, if at all; the accuracy of its financial projections; obtaining positive results in its clinical trials; its ability to obtain necessary regulatory approvals; its ability to arrange for the manufacturing of its product candidates and technologies; and general business, market and economic conditions. Many factors could cause the Company's actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements, including without limitation, a lack of revenue, insufficient funding, reliance upon key personnel, the uncertainty of the clinical development process, competition, and other factors set forth in the "Risk Factors" section of the Company's most recently filed Annual Information Form, which is available under the Company’s profile on SEDAR+ at www.sedarplus.ca (which are also incorporated in the recently filed form 40-F available on the website of the U.S. Securities and Exchange Commission (the “SEC") at www.sec.gov), including the management’s discussion & analysis for the year-ended December 31, 2025. All clinical development plans are subject to additional funding. Readers should not place undue reliance on forward-looking statements made in this news release. Furthermore, unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement. ContactsHuitt Tracey, [email protected] David Schull or Ignacio Guerrero-Ros, Ph.D., MediaRusso [email protected]@russopartnersllc.com858.717.2310

Investor releaseQuarter not tagged2026-03-31

NervGen Pharma Reports Full Year 2025 Financial Results and Provides Business Updates

GlobeNewswire
Completed End-of-Phase 2 meeting with the FDA; Company expects to provide a regulatory update in early 2Q 2026 and remains on track to initiate a Phase 3 study in chronic tetraplegia in mid-2026. Company expects to present clinical data from independent, blinded biomechanical gait analyses of the CONNECT SCI study in 2Q 2026, providing additional evidence with the potential to further support the systemic biological effect of NVG-291, differentiating genuine neural recovery from compensatory movement. Company expects to expand NVG-291 into complementary clinical indications, as informed by established preclinical efficacy, with prioritization expected to be announced by mid-2026. Successful Nasdaq listing and continued growth of leadership team supports the Company’s emergence as a leader in the development of neuroreparative therapeutics. VANCOUVER, British Columbia, March 31, 2026 (GLOBE NEWSWIRE) -- NervGen Pharma Corp. (“NervGen” or the “Company") (NASDAQ: NGEN), a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions, today reported its full year 2025 financial results and provided business updates. “2025 was a transformative year for NervGen, but more importantly the SCI community,” said Adam Rogers, MD, President and Chief Executive Officer of NervGen. “We’ve demonstrated the potential best-in-class profile of NVG-291 and its ability to meaningfully improve the lives of those with chronic tetraplegia in the CONNECT SCI study, and we continue to strengthen our understanding of the breadth and quality of that recovery.” “It is our responsibility now to make the promise of NVG-291 a reality and execute on both its increasingly de-risked late-stage clinical development and commercial potential,” continued Dr. Rogers. “We are now more confident than ever that we are positioned to carry forward our significant momentum through the rest of 2026. We look forward to providing a regulatory update and delivering on a series of meaningful catalysts throughout the year, including NVG-291’s expansion into complementary clinical indications and the initiation of our Phase 3 study in chronic tetraplegia in mid-2026.” Business Highlights NVG-291 Chronic Tetraplegia Clinical Development In June 2025, NervGen reported positive topline results from th…Read full document

Completed End-of-Phase 2 meeting with the FDA; Company expects to provide a regulatory update in early 2Q 2026 and remains on track to initiate a Phase 3 study in chronic tetraplegia in mid-2026. Company expects to present clinical data from independent, blinded biomechanical gait analyses of the CONNECT SCI study in 2Q 2026, providing additional evidence with the potential to further support the systemic biological effect of NVG-291, differentiating genuine neural recovery from compensatory movement. Company expects to expand NVG-291 into complementary clinical indications, as informed by established preclinical efficacy, with prioritization expected to be announced by mid-2026. Successful Nasdaq listing and continued growth of leadership team supports the Company’s emergence as a leader in the development of neuroreparative therapeutics. VANCOUVER, British Columbia, March 31, 2026 (GLOBE NEWSWIRE) -- NervGen Pharma Corp. (“NervGen” or the “Company") (NASDAQ: NGEN), a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions, today reported its full year 2025 financial results and provided business updates. “2025 was a transformative year for NervGen, but more importantly the SCI community,” said Adam Rogers, MD, President and Chief Executive Officer of NervGen. “We’ve demonstrated the potential best-in-class profile of NVG-291 and its ability to meaningfully improve the lives of those with chronic tetraplegia in the CONNECT SCI study, and we continue to strengthen our understanding of the breadth and quality of that recovery.” “It is our responsibility now to make the promise of NVG-291 a reality and execute on both its increasingly de-risked late-stage clinical development and commercial potential,” continued Dr. Rogers. “We are now more confident than ever that we are positioned to carry forward our significant momentum through the rest of 2026. We look forward to providing a regulatory update and delivering on a series of meaningful catalysts throughout the year, including NVG-291’s expansion into complementary clinical indications and the initiation of our Phase 3 study in chronic tetraplegia in mid-2026.” Business Highlights NVG-291 Chronic Tetraplegia Clinical Development In June 2025, NervGen reported positive topline results from the Phase 1b/2a CONNECT SCI study in chronic tetraplegia (1-10 years post-injury). NVG-291 met its primary endpoint, demonstrating statistically significant improvement in upper-limb corticospinal connectivity (p=0.0155), with an 825% improvement versus placebo in functional hand use, as measured by GRASSP Quantitative Prehension. Additional analyses reported in November 2025 further support the biological basis for NVG-291’s observed clinical effects, including statistically significant improvement in the normalization of maladaptive hyperexcitable reticulospinal activity in the upper (p=0.0280) and lower limbs (p=0.0062). Functional improvements were durable, both persisting and continuing to improve beyond the 12-week treatment period, as reported at Week 16 and via blinded qualitative exit interviews conducted up to 364 days after the study period. Independent, blinded biomechanical gait analyses of the CONNECT SCI study are ongoing, conducted by a specialized third-party motion analysis group to provide additional evidence with the potential to further support the systemic biological effect of NVG-291, differentiating genuine neural recovery from compensatory movement. These analyses assess joint kinematics, inter-joint coordination, and postural stability across treatment groups. The Company expects to present these data in 2Q 2026. NervGen completed its End-of-Phase 2 meeting with the FDA in 1Q 2026 and expects to provide a regulatory update in early 2Q 2026. The Company previously completed a Type C Meeting in September 2025, in which FDA indicated that multiple regulatory pathways may be available to support approval, given the significant unmet need among the SCI community and the lack of approved pharmacologic treatments. The Company remains on track to initiate its Phase 3 study in chronic tetraplegia in mid-2026. NVG-291 Subacute Tetraplegia Clinical Development NervGen expects to provide an update on the status of the Phase 1b/2a CONNECT SCI study in subacute tetraplegia in 2Q 2026. NVG-291 Clinical Indication Expansion NervGen expects to expand NVG-291 into complementary clinical indications, as informed by established preclinical efficacy, with prioritization expected to be announced by mid-2026. NVG-291 has demonstrated preclinical efficacy across more than 15 unique models of neurotraumatic and neurologic conditions, including in collaboration with the U.S. Department of Defense and leading independent academic institutions. Growth of Senior Leadership In 2025 and early 2026, NervGen strengthened its leadership team with the appointments of Dr. Adam Rogers as Chairman, President and Chief Executive Officer and Dr. Randall Kaye as Chief Medical Advisor. In March 2026, NervGen appointed Shamim Ruff as Chief Regulatory Affairs Officer, bringing more than 30 years of regulatory leadership experience, and Christine McSherry as SVP, Patient Advocacy and Clinical Affairs, adding deep expertise in patient-focused drug development. In March 2026, NervGen announced the retirement of Bill Adams as Chief Financial Officer and engaged a leading executive search firm to identify a successor. Mr. Adams has remained in an advisory capacity to support the transition. Full Year 2025 Financial Results Cash and Investments. As of December 31, 2025, NervGen had cash and investments of $22.1 million, compared to $17.3 million as of December 31, 2024. The increase is primarily due to proceeds from the private placement completed in November 2025, as well as proceeds from warrant and option exercises, partially offset by ongoing operating expenditures. Research & Development (R&D). R&D expenses were $13.9 million for the year ended December 31, 2025, compared to $15.8 million for the year ended December 31, 2024. The decrease is primarily related to the completion of the chronic cohort of the CONNECT SCI study, with lower preclinical development costs as resources are concentrated on NVG-291 manufacturing and clinical development, as well as procuring drug supply for future NVG-291 clinical trials. General and Administrative (G&A). G&A expenses were $11.2 million for the year ended December 31, 2025, compared to $9.4 million for the year ended December 31, 2024. The increase is primarily related to increased legal and professional expenses associated with the Company's Nasdaq listing. Net Loss. Net loss was $44.1 million for the year ended December 31, 2025, or $0.61 per weighted-average common share outstanding, basic and diluted, including $24.8 million of non-cash expenses pertaining to amortization, stock-based compensation, unrealized foreign exchange and the fair value adjustment of the warrant derivative. This is compared to a net loss of $24.3 million for the year ended December 31, 2024, or $0.36 per weighted-average common share outstanding, basic and diluted, including $6.0 million of non-cash expenses pertaining to amortization, depreciation, stock-based compensation, unrealized foreign exchange and the fair value adjustment of the warrant derivative. About NervGen Pharma NervGen Pharma Corp. (NASDAQ: NGEN) is a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions. The Company’s mission is to transform the lives of individuals living with SCI by enabling the nervous system to repair itself. NervGen’s lead therapeutic candidate, NVG-291, is a subcutaneously administered, neuroreparative peptide designed to target the inhibitory CSPG-PTPσ pathway. NVG-291 is the first pharmacologic candidate to improve function, independence, and quality of life in chronic tetraplegia, as demonstrated in the Phase 1b/2a CONNECT SCI study. NVG-291 has received Fast Track designation from the FDA and Orphan Drug designation from the European Medicines Agency for the treatment of SCI. Through NVG-291 and the Company’s next-generation candidate, NVG-300, NervGen is pursuing a pharmacologic approach to transform the treatment paradigm for neurotraumatic and neurologic conditions with significant unmet medical need. For more information, visit www.nervgen.com and follow NervGen on X and LinkedIn. Contacts Huitt Tracey, Investors [email protected] 604.537.2094 David Schull or Ignacio Guerrero-Ros, Ph.D., Media Russo Partners [email protected] [email protected] 858.717.2310 Cautionary Note and Forward Looking-Statements This news release may contain "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws (collectively, "forward-looking statements"). Such forward-looking statements herein include but are not limited to, the Company's current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or any other future events or developments constitute forward-looking statements, and the words "may", "will", "would", "should", "could", "expect", "plan", "intend", "trend", "indication", "anticipate", "believe", "estimate", "predict", "likely" or "potential", or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements include, without limitation, statements relating to: the Company's potentially best-in-class candidate, NVG-291; the potential broad therapeutic applications of NVG-291; the regulatory pathways available to the Company for NVG-291; the objectives, planned clinical endpoints, timing, expected rate of enrollment, and results from the Company's Phase 1b/2a clinical trial of NVG-291 in individuals with subacute spinal cord injury; the anticipated time of initiating a Phase 3 clinical trial in chronic tetraplegia; the potential of NVG-291 to address the unmet medical need for patients with SCI; ; the anticipated timing of additional data and analyses relating to NVG-291 for SCI; the procurement of drug supply for future NVG-291 clinical trials; the sufficiency of the Company's cash and investments to fund its operations and clinical development plans; and the creation of neuroreparative therapeutics to enable the nervous system to repair itself in settings of neurotrauma and neurologic disease. Forward-looking statements are based on estimates and assumptions made by the Company in light of management's experience and perception of historical trends, current conditions and expected future developments, as well as other factors that we believe are appropriate and reasonable in the circumstances. In making forward-looking statements, the Company has relied on various assumptions, including, but not limited to: its ability to obtain future funding on favorable terms, if at all; the accuracy of its financial projections; obtaining positive results in its clinical trials; its ability to obtain necessary regulatory approvals; its ability to arrange for the manufacturing of its product candidates and technologies; and general business, market and economic conditions. Many factors could cause the Company's actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements, including without limitation, a lack of revenue, insufficient funding, reliance upon key personnel, the uncertainty of the clinical development process, competition, and other factors set forth in the "Risk Factors" section of the Company's most recently filed Annual Information, which is available under the Company’s profile on SEDAR+ at www.sedarplus.ca (which are also available on the website of the U.S. Securities and Exchange Commission (the “SEC") at www.sec.gov), including the management’s discussion & analysis for the year-ended December 31, 2025. All clinical development plans are subject to additional funding. Readers should not place undue reliance on forward-looking statements made in this news release. Furthermore, unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

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