Tillkännagivande • 10h
NervGen Pharma Corp. has filed a Follow-on Equity Offering. NervGen Pharma Corp. has filed a Follow-on Equity Offering.
Security Name: Common Shares
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Tillkännagivande • Apr 29
Nervgen Pharma Corp. Announces Appointment of Keith Vendola as Chief Financial Officer, Effective April 27, 2026 NervGen Pharma Corp. announced the appointment of Keith Vendola, MD, MBA, as Chief Financial Officer, effective April 27, 2026. Dr. Vendola will lead the Company’s financial strategy and operations, including capital markets activity, financial planning, corporate development and supporting strategic initiatives. With more than two decades of experience spanning financial and strategic roles at clinical-stage biopharmaceutical companies, healthcare investment banking, corporate strategy, and scientific research, Dr. Vendola brings a distinctive combination of capital markets, operational, and medical expertise to NervGen. Dr. Vendola joins NervGen from Wugen, a clinical-stage cell therapy company, where he served as CFO. Prior to Wugen, he was CFO of IO Biotech, leading the company through its IPO. Earlier in his career, he served as CFO 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 CEO and Vice President of Competitive Strategy and Investor Relations at Coherus BioSciences, where his responsibilities spanned corporate development, strategy, and operations. Dr. Vendola began his corporate finance career as a healthcare investment banker at BofA Securities and JPMorgan Chase. Dr. Vendola earned his MBA in finance from Northwestern's Kellogg School of Management, MD from Dartmouth Medical School, and BA in psychology, with honors, from the College of the Holy Cross. He completed an executive education program in strategic negotiations at Harvard Business School and was a research fellow at the National Institutes of Health. Tillkännagivande • Apr 08
NervGen Pharma Corp Announces Successful End-Of-Phase 2 Meeting And FDA Alignment On RESTORE, A Phase 3 Registrational Study Of NVG-291 For Chronic Tetraplegia NervGen Pharma Corp. completed a successful End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) and alignment on RESTORE, the Company’s Phase 3 registrational study designed to evaluate NVG-291 for the treatment of chronic tetraplegia. Alignment with the FDA across proposed study parameters of RESTORE, a 16-week registrational study evaluating NVG-291 in chronic tetraplegia. Primary endpoint will be the change from baseline in GRASSP Quantitative Prehension at Week 12, a validated functional endpoint designed to capture improvement in fine-motor hand use, the highest priority domain in tetraplegia. Key secondary endpoints include Patient and Clinician Global Impression of Change (PGIC/CGIC), and blinded qualitative interviews designed to contextualize the clinical meaningfulness of NVG-291. RESTORE initiation remains on-track for mid-2026, with study initiation activities underway. Overview of the RESTORE Phase 3 Registrational Study Design: Study Design: Randomized, double-blind, placebo-controlled; approximately 150 subjects. Population Characteristics: Adults aged 18-75 with chronic tetraplegia due to traumatic SCI (=C7; ASIA Impairment Scale C or D), 1-10 years post-injury. Study Sites: Up to 60 sites across the United States and Canada. Dosing Regimen: Daily subcutaneous injections of NVG-291 for 12 weeks, followed by a 4-week observational period. Primary Endpoint: Change from baseline to Week 12 in GRASSP Quantitative Prehension (QtP), a validated measure of functional hand use. Key Secondary Endpoints: PGIC, CGIC, Spinal Cord Independence Measure, Version-III (SCIM-III), and lower extremity spasticity, as measured by the Modified Ashworth Scale. Qualitative Assessments: Blinded qualitative interviews will be conducted when exiting the 16-week study period to contextualize the clinical meaningfulness and real-world impact of NVG-291. Open-Label Extension (OLE): An optional 12-week OLE will follow the main study, providing access to NVG-291 for all placebo-randomized subjects. The RESTORE registrational study remains on-track for initiation in mid-2026, with study initiation activities underway. Phase 1b/2a CONNECT SCI Chronic Tetraplegia Data Supports the RESTORE Phase 3 Registrational Study Design. Data from the randomized, placebo-controlled Phase 1b/2a CONNECT SCI study in chronic tetraplegia supports the RESTORE registrational study design, including endpoint selection, timing of assessments, and dosing regimen. Primary Endpoint Selection (GRASSP QtP): A mean improvement of +3.7 points at Week 12 in NVG-291-treated subjects versus +0.4 points for placebo-treated subjects (+3.3-point treatment difference), exceeding the 2.0-point minimally important difference. Sustained Treatment Effect at Week 16: Continued improvement in GRASSP QtP to +4.4 points for NVG-291-treated subjects versus +1.2 points for placebo-treated subjects, demonstrating a sustained treatment effect at Week 16, four weeks after treatment cessation. Clinical Meaningfulness (PGIC): 75% (6/8) of NVG-291-treated subjects reported being “much” or “very much” improved (=6/7 PGIC score) versus 33% (3/9) of placebo-treated subjects, reinforcing the relevance of observed functional gains. Real-World Impact: Blinded qualitative interviews conducted up to 364 days post-study contextualized systemic improvements, including 67% (6/9) of NVG-291-treated subjects reporting improved bladder control and 56% (5/9) reporting reduced muscle spasticity. Dosing Regimen and Safety: Favorable safety and tolerability across 12 weeks of daily subcutaneous dosing of NVG-291, with no treatment-related serious adverse events or treatment discontinuations. Phase 1b/2a CONNECT SCI Subacute Tetraplegia Update. Following a successful EOP2 meeting and FDA alignment across the proposed study parameters of RESTORE, NervGen has elected to conclude enrollment in the Phase 1b/2a CONNECT SCI study in subacute tetraplegia and unblind available data. FDA alignment on the RESTORE registrational study design emphasizes clinical endpoints that capture how individuals with chronic tetraplegia function, feel, and succeed in everyday life. The Company intends to apply this regulatory alignment and endpoint framework to inform a future registrational-quality study in subacute tetraplegia. Tillkännagivande • Mar 06
NervGen Pharma Corp. Announces Executive Changes NervGen Pharma Corp. appointed Shamim Ruff as Chief Regulatory Affairs Officer and Christine McSherry as Senior Vice President (SVP), Patient Advocacy and Clinical Affairs. Shamim Ruff brings more than 30 years of strategic leadership in regulatory affairs to NervGen, where she will oversee the company’s regulatory strategy and work closely with the executive team to support the realization of NervGen’s mission to transform the lives of individuals living with SCI. Most recently, Ms. Ruff served as Chief Regulatory Affairs Officer and SVP, 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 CEO and NDA Submissions Team at Soleno Therapeutics and on the Board of Directors of Reata Pharmaceuticals until its acquisition by Biogen. Her earlier career included leadership roles at Sanofi-Genzyme, Amgen, Abbott, and AstraZeneca. Ms. Ruff holds a master's degree in analytical chemistry from the University of Loughborough, U.K., and a bachelor's degree in chemistry and biology from the University of Leicester, U.K. Christine McSherry brings more than 30 years of experience bridging patient advocacy and clinical development. She will play a pivotal role in ensuring the voice of the SCI community is central to NervGen’s clinical strategy. Previously, 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 CEO of Casimir until its acquisition by Emmes. In 2001, she founded the Jett Foundation, after 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 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. She holds a BSN from Northeastern University and is a registered nurse. Recent Insider Transactions • Mar 03
Insider recently sold US$80k worth of stock On the 2nd of March, Krista McKerracher sold around 20k shares on-market at roughly US$3.98 per share. This transaction amounted to 30% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger sale worth US$115k. Insiders have been net sellers, collectively disposing of US$235k more than they bought in the last 12 months. New Risk • Feb 24
New minor risk - Insider selling There has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: US$155k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Major Risks Negative equity (-CA$2.9m). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Significant insider selling over the past 3 months (US$155k sold). 
