- Announced unprecedented Phase 1b/2a topline results in chronic spinal cord injury
- NVG-291 is the first pharmacologic candidate to demonstrate statistically significant improvement in corticospinal connectivity with clinically meaningful functional gains
- Ongoing comprehensive analysis of NVG-291's efficacy profile will support upcoming regulatory discussions, including seeking alignment with FDA on potential expedited approval pathways
Letter from Adam Rogers, MD, Chairman and Interim Chief Executive Officer:
To my fellow shareholders,
The medical community has long been taught that after spinal cord injury, neurons surrounding a lesion become dystrophic and die, leaving little hope for recovery. The late Dr. Jerry Silver devoted his career to challenging this narrative, and in doing so, laid the scientific foundation for NervGen.
As Chairman and NervGen's largest investor, I stepped into the role of Interim Chief Executive Officer because I am determined to ensure that the breakthrough science and pioneering vision of Dr. Silver, whose life's work culminated in the creation of NVG-291, fulfills its potential to restore function and independence for people living with spinal cord injury (SCI).
In carrying forward this vision, I am committed to raising the standard of communication at NervGen. We will provide shareholders and the SCI community with clear, accessible insights and transparent interpretations of our results, so that the impact of our CONNECT SCI Study, and the promise NVG-291 holds, is fully recognized and appreciated.
The second quarter of 2025 marked a historic turning point for NervGen and the SCI community. After decades of virtually no therapeutic progress in spinal cord injury, we announced unprecedented topline results from our CONNECT SCI Study. We show for the first time that daily subcutaneous NVG-291 treatment, a pharmacologic candidate, significantly improved corticospinal connectivity and restored meaningful function for people with chronic SCI. These results represent both a scientific breakthrough and a pivotal step forward for the millions worldwide living with spinal cord injuries.
For too long, the standard of care in SCI has been limited to acute stabilization and rehabilitation, offering little to no path to functional recovery. NervGen is redefining this outdated paradigm. Our mission is to advance NVG-291 and establish a new standard of care capable of restoring function, increasing independence, and transforming lives.
The coming months represent a significant inflection point as we move from proof-of-concept success into the next stage of development. Since sharing positive topline data from our CONNECT SCI Study, we have initiated a comprehensive analysis of NVG-291's efficacy profile, which remains ongoing. To fully characterize these results, we are collaborating with key opinion leaders at leading spinal cord injury centers of excellence, along with clinical experts, bioinformatics specialists, and patient advocacy organizations. This forthcoming analysis will guide near-term regulatory discussions with the U.S. Food and Drug Administration (FDA), including seeking alignment on expedited pathways and designations that could potentially accelerate access to NVG-291 for people living with spinal cord injury.
NervGen stands at a rare moment of opportunity. Our CONNECT SCI Study topline results are more than a milestone; they demonstrate that recovery after spinal cord injury is possible. We are advancing NVG-291 to establish a future in which pharmacologic therapy can restore function and increase independence for people living with spinal cord injury. With the continued trust of our shareholders, the engagement of the SCI community, and the dedication of the NervGen team, we enter a new chapter defined by purpose, progress, and renewed hope.
Sincerely,
Adam Rogers, MD
Chairman and Interim CEO
NervGen Pharma Corp.
Pipeline Progress
The Company has initiated a comprehensive analysis of NVG-291's efficacy profile following its CONNECT SCI Study topline results. This forthcoming analysis will guide near-term regulatory discussions with the FDA, including seeking alignment on expedited pathways and designations to potentially accelerate access to NVG-291 for people living with spinal cord injury.
In August 2025, the Company announced positive preclinical results from two U.S. Department of Defense sponsored studies, where NVG-291-R demonstrated significant functional recovery in models of traumatic hearing loss and peripheral nerve injury (PNI):
Novel Preclinical Findings in Blast-Induced Sensorineural Hearing Loss
- Significant Hearing Restoration: In a rat model exposed to shock waves, either a single high-pressure blast or a series of low-pressure blasts, daily subcutaneous NVG-291-R treatment led to statistically significant improvements in hearing thresholds across all frequencies by end-of-study at Day 30, preventing profound and permanent hearing loss observed in untreated animals.
- Significant Neuromuscular Function and Axonal Regeneration: In moderate and severe models of PNI, daily subcutaneous NVG-291-R treatment led to statistically significant improvements in neuromuscular function and axonal regrowth. Increases in compound muscle action potentials and specific tetanic force were associated with a higher total number and density of axons distal to the injury site. Functional and regenerative gains were observed as early as 4 weeks post-injury.
Landmark Proof-of-Concept Efficacy and Safety in Chronic SCI
NVG-291 is the first pharmacologic candidate to demonstrate statistically significant improvements in corticospinal connectivity to the hand (first dorsal interosseous), as measured by motor evoked potential (MEP) magnitude, with clinically meaningful functional gains in chronic cervical incomplete SCI.
Electrophysiological Efficacy in the Hand
- Results reported as improvement in normalized MEP magnitude in the first dorsal interosseous, a measure of corticospinal connectivity in the hand
- 10.2-fold improvement in observed mean change from baseline at end-of-treatment vs. placebo
- 5.7-fold improvement based on linear mixed effects estimated change from baseline
vs. placebo, demonstrating statistically significant improvement (p = 0.0155) - 3.0-fold improvement in observed mean change from baseline at end-of-treatment within the NVG-291 group, as previously announced on June 2, 2025
- Results reported as observed mean change from baseline vs. placebo
- 2.0-fold improvement in total GRASSP scores (cumulative measure of all GRASSP domains)
- 9.3-fold improvement in quantitative prehension (measure of functional hand use in activities of daily living)
- 5.2-fold improvement in qualitative prehension (measure of preparation and initiation of functional hand use in activities of daily living)
- NVG-291 was generally safe and well tolerated, with no treatment-emergent adverse events leading to discontinuation or serious adverse events
In July 2025, NervGen transitioned its senior leadership to ensure continuity of its mission and position the Company for the next stage of NVG-291 development. Adam Rogers, MD, was appointed Interim Chief Executive Officer and Randall Kaye, MD, as Chief Medical Advisor:
- Adam Rogers, MD, Chairman and largest shareholder, is a board-certified physician and seasoned biotech executive. He most recently served as founder and CEO of Hemera Biosciences for more than a decade until its acquisition by Janssen Pharmaceuticals, Inc.
- Randall Kaye, MD, brings over 30 years of medical expertise and extensive clinical development experience in central nervous system conditions and disorders. He most recently served as Chief Medical Officer of Longboard Pharmaceuticals, where he helped guide the company through its $2.6 billion acquisition by H. Lundbeck A/S.
Cash and Investments: NervGen had cash and investments of $15.7 million as of June 30, 2025, compared to $17.3 million as of December 31, 2024. The decrease in funds available is due to operating activities related to the ongoing CONNECT SCI Study, which were partially offset by proceeds from the Company's ATM program, warrant exercises, and option exercises in the current year.
Research & Development (R&D) Expenses: R&D expenses were $2.7 million for the three months ended June 30, 2025, compared to $3.8 million in the same period in 2024. The decrease in the three months ended June 30, 2025, is related to lower clinical and regulatory costs primarily due to a grant milestone earned during the period which is recorded as an offset to clinical costs and decreased costs due to the completion of the chronic cohort of the CONNECT SCI Study during the quarter. Decreased clinical spend was offset by increased costs incurred for research, preclinical, and quality related initiatives.
General and Administrative (G&A) Expenses: G&A expenses were $3.8 million for the three months ended June 30, 2025, compared to $2.2 million for the same period in 2024. The increase in the three months ended June 30, 2025, is primarily related to higher compensation related expenses, including non-cash stock-based compensation expense. Additionally, expenses were higher due to external legal counsel costs in relation to Canadian and U.S. corporate securities matters.
Net Loss: For the three months ended June 30, 2025, net loss was $9.1 million, or $0.13 per basic and diluted common share. The net loss for the quarter included $4.8 million of non-cash expenses pertaining to amortization, stock-based compensation, unrealized foreign exchange and a $2.7 million non-cash loss due to the fair value adjustment of the warrant derivative. For the three months ended June 30, 2024, net loss was $7.8 million, or $0.11 per basic and diluted common share which included $3.5 million of net non-cash expenses pertaining to amortization, stock-based compensation, unrealized foreign exchange gain on cash and a $2.2 million non-cash loss due to the fair value adjustment of the warrant derivative.
About NVG-291
NervGen holds exclusive worldwide rights to NVG-291, a first- and potential best-in-class therapeutic peptide targeting nervous system repair. NVG-291's technology is licensed from Case Western Reserve University and is based on academic studies that demonstrated the preclinical efficacy of NVG-291-R, the rodent variant of NVG-291, in animal models of spinal cord injury. These studies implicated multiple potential molecular and cellular mechanisms by which NVG-291-R promotes neurorepair and functional improvement in both central and peripheral nervous system injury models. The implicated mechanisms include the promotion of neuronal sprouting, or plasticity, remyelination, and promotion of a non-inflammatory phenotype in the microglial cells. NervGen has received Fast Track designation from the FDA and Orphan Designation from the EMA for NVG-291 in individuals with spinal cord injury.
About NervGen
NervGen (TSXV: NGEN) (OTCQB: NGENF) is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies to promote nervous system repair in settings of neurotrauma and neurologic disease. The Company is evaluating the clinical efficacy of its first- and potential best-in-class lead candidate, NVG-291, in the Phase 1b/2a CONNECT SCI Study in spinal cord injury. Topline data from the chronic cohort (1-10 years post-injury) of this trial showed that NVG-291 significantly increased electrophysiological connectivity and demonstrated clinically meaningful functional gains. Continued analysis of NVG-291's efficacy profile is ongoing. Enrollment in the subacute cohort (20-90 days post-injury) of the trial continues, and more information about participation in the subacute study is available at www.connectscistudy.com. For more information about NervGen, visit www.nervgen.com and follow NervGen on X and LinkedIn for the latest news on the company.
Contacts
Huitt Tracey, Investors
htracey@nervgen.com
604.537.2094
David Schull or Ignacio Guerrero-Ros, Ph.D., Media
Russo Partners
David.Schull@russopartnersllc.com
Ignacio.Guerrero-Ros@russopartnersllc.com
858.717.2310
Bill Adams, Chief Financial Officer
info@nervgen.com
778.731.1711
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Cautionary Note and Forward Looking-Statements
This news release may contain "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian and United States securities legislation (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 potential best-in-class candidate, NVG-291; the potential broad therapeutic applications of NVG-291; the future growth of the Company; the Company's mission of transforming the lives of individuals living with spinal cord injury; the objectives, planned clinical endpoints, timing, expected rate of enrollment, and final results from our Phase 1b/2a clinical trial of NVG-291 in individuals with spinal cord injury; the future development plans and benefits of NVG-291; our upcoming regulatory discussions including potential accelerated development pathways; and the creation of neuro-reparative therapeutics to promote nervous system repair 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 prospectus supplement, short form base shelf prospectus, annual information form, financial statements and management discussion and analysis all of which can be found on NervGen's profile on SEDAR+ at www.sedarplus.ca. 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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