Anuncio • 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. Anuncio • 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. Anuncio • 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). Recent Insider Transactions • Feb 24
Insider recently sold US$115k worth of stock On the 20th of February, Krista McKerracher sold around 30k shares on-market at roughly US$3.83 per share. This transaction amounted to 31% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$155k more than they bought in the last 12 months. Recent Insider Transactions • Feb 19
Insider recently sold US$40k worth of stock On the 12th of February, Krista McKerracher sold around 10k shares on-market at roughly US$4.00 per share. This transaction amounted to 9.3% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months. Anuncio • Feb 17
NervGen Pharma Corp., Annual General Meeting, Apr 23, 2026 NervGen Pharma Corp., Annual General Meeting, Apr 23, 2026. Location: ontario, toronto Canada Anuncio • Feb 14
NervGen Pharma Corp. Announces Executive Changes, Effective March 15, 2026 NervGen Pharma Corp. announced that William J. Adams tendered his resignation as Secretary and Principal Financial and Accounting Officer of the Company, due to his retirement. Mr. Adams' resignation is effective as of March 15, 2026. Mr. Adams' resignation was not the result of any disagreements with the Company, its management or the Company's Board of Directors. On February 12, 2026, the Board approved the appointment of Dr. Adam Rogers as the Company's Principal Financial and Accounting Officer, effective as of March 15, 2026. Anuncio • Feb 13
NervGen Pharma Corp. Announces CFO Changes, Effective March 15, 2026 NervGen Pharma Corp. announced that Bill Adams will retire as Chief Financial Officer, effective March 15, 2026. The Company has engaged a leading executive search firm to identify a successor, and Mr. Adams will continue in an advisory capacity following his retirement date to support the transition. On February 12, 2026, the Board approved the appointment of Dr. Adam Rogers as the Company’s interim Chief Financial Officer and the Company’s Principal Financial and Accounting Officer, effective as of March 15, 2026. Breakeven Date Change • Jan 08
Forecast to breakeven in 2028 The 2 analysts covering NervGen Pharma expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of CA$1.09m in 2028. Average annual earnings growth of 71% is required to achieve expected profit on schedule. Anuncio • Jul 02
NervGen Pharma Corp. Announces Resignation of Daniel Mikol, MD, Ph.D as Chief Medical Officer NervGen Pharma Corp. announced resignation of Daniel Mikol, MD, Ph.D as Chief Medical Officer in order to pursue new opportunities. Randall Kaye, MD, who was recently appointed Chief Medical Advisor, will increase the scope of his role as the company initiates a search for Dr. Mikol's replacement. Anuncio • Jun 02
NervGen Pharma Corp. Reports Positive Topline Data from the Chronic Cohort of its Phase 1b/2a Clinical Trial Evaluating NVG-291 in Spinal Cord Injury NervGen Pharma Corp. announced positive Topline results from the chronic cohort (1-10 years post injury) of its Phase 1b/2a clinical trial evaluating its lead drug candidate, NVG-291, as a potential treatment for spinal cord injury. The double-blind, placebo-controlled proof-of-concept Phase 1b/2a Clinical trial (NCT05965700) evaluates the safety and efficacy of NVG-291 in two separate cohorts of individuals with cervical motor incomplete spinal cord injury: chronic (1-10 years post-in injury) and subacute (20-90 days post-in injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial. NervGen has received Fast Track designation from the FDA for NVG-291 in individuals with spinal cord injury. The company is testing the clinical efficacy of its lead candidate, NVG-291. in a Phase 1b/2 a clinical trial in spinal cord injury and has initiated preclinical test of concept evaluation of pipeline candidate, NVG-300, in models of neurotrauma and spinal cord injury. As the first pharmaceutical candidate to show improved motor recovery based on increased motor evoked potential amplitude, these study results represent a significant scientific advance and step forward in the potential to treat SCI, where there remains no approved pharmaceuticals to enable sustained functional recovery. Topline safety and efficacy results reinforce the potential of NVG-291 to promote nervous system repair in individuals living with traumatic cervical SCI, the expected benefits of changes in upper extremity motor function for individuals living with SCI and the potential to otherwise treat SCI. Anuncio • Mar 05
NervGen Pharma Corp., Annual General Meeting, May 06, 2025 NervGen Pharma Corp., Annual General Meeting, May 06, 2025. Location: ontario, toronto Canada Anuncio • Feb 08
NervGen Pharma Corp. Completes Dosing of First Subject in Subacute Cohort of its Phase 1b/2a Clinical Trial of NVG-291 in Spinal Cord Injury NervGen Pharma Corp. announced that the first subject has been enrolled and dosed in the subacute cohort of its Phase 1b/2a proof-of-concept, double-blind, randomized placebo-controlled clinical trial (NCT05965700) evaluating its lead candidate, NVG-291, in individuals with spinal cord injury (SCI). The company previously reported the completion of enrollment of the chronic cohort and announced that results for the chronic cohort are expected in Second Quarter 2025. Recently, the company received IRB approval for an amendment focused on the subacute cohort of the Phase 1b/2a clinical trial. Key changes to the protocol were implemented to facilitate enrollment, for example, revising the timing of subacute SCI to 20 to 90 days post-injury, and to decrease the burden on study participants by reducing the number of visits and assessments. About Phase 1b/2a Trial. The double-blind, placebo-controlled proof-of-concept Phase 1b/2aclinical trial (NCT05965 700) evaluates the safety and efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (20-90 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate the efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function. The trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial. NVG-291 has received Fast Track designation in spinal cord injury from the U.S. Food and Drug Administration. Anuncio • Jan 02
NervGen Pharma Corp. Completes Enrollment in Chronic Cohort of its Phase 1b/2a Clinical Trial of NVG-291 in Spinal Cord Injury NervGen Pharma Corp. announced that it has enrolled the 20th and final subject in the chronic cohort of its Phase 1b/2a proof-of-concept, double-blind, randomized placebo-controlled clinical trial (NCT05965700) evaluating its lead candidate, NVG-291, in individuals with spinal cord injury (SCI). Furthermore, the company has received IRB approval for an amendment to its Phase 1b/2 a clinical trial and has initiated the screening of subjects for the subacute cohort of the study. The double-blind, placebo-controlled proof-of-concept Phase 1b/2a clinical trial (NCT059 65700) evaluates the safety and efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (20-90 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate the efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function. Specifically, the primary objective is to assess the change in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment based on changes in motor evoked potential amplitudes. Secondary objectives are to evaluate changes in a number of clinical outcome assessments focusing on motor function and strength, as well as changes in additional electrophysiological measurements. The cohorts will be comprised of approximately 20 subjects each and will be evaluated independently as the data becomes available. The trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial. Anuncio • Dec 20
NervGen Pharma Corp. has filed a Follow-on Equity Offering in the amount of CAD 30 million. NervGen Pharma Corp. has filed a Follow-on Equity Offering in the amount of CAD 30 million.
Security Name: Common Shares
Security Type: Common Stock
Transaction Features: At the Market Offering Anuncio • Jul 25
NervGen Pharma Corp. Appoints Neil Klompas to Board of Directors NervGen Pharma Corp. announced the appointment of Mr. Neil Klompas to the company's Board of Directors. Mr. Klompas is an experienced life sciences and healthcare sector executive and board member, who recently served as President and Chief Operating Officer of Zymeworks Inc. During his time with the company, he oversaw finance and operations executing the company's initial public offering on the NYSE and TSX. Prior to Zymeworks, Mr. Klompas worked with KPMG LLP as part of the Pharmaceutical, Biotech Medical Devices MA Transaction Services practice in Princeton, NJ, and with KPMG LLP in the life sciences assurance practice based in Vancouver. Mr. Klompas has served as Board Chair for Ovensa Inc., and as the Chair of the Audit Committee and Special Committee of Liminal Biosciences Inc. until its acquisition in 2023. He holds his BSc in Microbiology Immunology from the University of British Columbia and is a Chartered Professional Accountant. The company also announced that it has granted 150,000 incentive stock options to Mr. Klompas exercisable at a price of $2.85 per share for a period of five years and that vest equally every three months over a one-year period. All options have been granted in accordance with the policies of the TSX Venture Exchange and the conditions of the company's stock option plan. Anuncio • Jun 06
NervGen Pharma Corp. Approves Board and Audit Committee Elections NervGen Pharma Corp. at the AGM held on June 4, 2024, approved to appoint John Ruffolo as the new Chair of Audit Committee. As the Founder and Managing Partner of Maverix Private Equity, founder of OMERS Ventures and a Fellow of the Chartered Professional Accountants, John's experience is a great fit to support NervGen's growth. Glenn Ives was elected by his fellow Board members as Chair of the Board following the AGM. As a past Chair of Deloitte Canada and the Deloitte Global Risk Committee, Glenn's experience is well suited to lead NervGen's board as they advance their programs into later-stage clinical development. Anuncio • Oct 26
NervGen Pharma Corp. Receives Fast Track Designation for NVG-291 for the Treatment of Individuals with Spinal Cord Injury NervGen Pharma Corp. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI). FDA's Fast Track program is designed to facilitate the development of drugs intended to treat serious conditions and fill unmet medical needs as part of the FDA's goal to get important new drugs to patients earlier. Fast Track also provides eligibility for both Priority Review, which can shorten the New Drug Development (NDA) review process, and for Accelerated Approval, which can allow for an earlier or faster approval based on a surrogate or intermediate clinical endpoint. Anuncio • Oct 18
Nervgen Pharma Appoints John Ruffolo to Board of Directors NervGen Pharma appointed John Ruffolo to Board of Directors . He has Extensive experience in private equity, venture capital and advising high growth, innovative companies, Brings personal experience and knowledge of spinal cord injury to NervGen's board, Important board addition joins as Company advances clinical milestone with Phase 1b/2a study of NVG-291 underway. John Ruffolo is the Founder and Managing Partner of Maverix Private Equity, a private equity firm focused on innovation-enabled growth and disruption investment strategies. Previously he founded OMERS Ventures, the venture capital arm of the large Ontario pension fund where he led early investments in startup success stories such as Shopify Inc. He has also championed Canada's technology industry as a co-founder of the Council of Canadian Innovators, along with former Research in Motion co-CEO Jim Balsillie. As an active board member in the profit and not-for-profit sectors, John currently works with many leading innovative organizations includingAI Partnerships Corp., engineering.com, OneEleven, the Rick Hansen Foundation, the CIBC Foundation, Caldwell's Top 40 Under 40, the Investigative Journalism Foundation, and the Dean's Global Council for the Schulich School of Business. The Company also announced that it has granted 150,000 incentive stock options to Mr. Ruffolo exercisable at a price of $1.75 per share for a period of five years and that vest equally every three months over a one-year period. Anuncio • Sep 26
NervGen Pharma Corp. Announces First Subject Dosed in Landmark Phase 1b/2a Clinical Trial for NVG-291 in Spinal Cord Injury NervGen Pharma Corp. announced the first subject has been dosed in the Company's landmark Phase 1b/2a proof-of-concept placebo-controlled clinical trial for its proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI). Given there are approximately 300,000 people with SCI living in the United States alone, the limited number of clinical trials in this area and the tremendous anticipation for this trial within the SCI community, recruitment for the chronic cohort (1-10 years post injury) is anticipated to happen relatively quickly with results expected by mid-2024. Results from the subacute cohort (10-49 days post-injury) are expected in late 2024/early 2025. The trial is being conducted at Shirley Ryan AbilityLab in Chicago. Anuncio • Feb 16
NervGen Pharma Announces Completion of Dosing of All Subjects in Phase 1 Clinical Trial of Proprietary Drug Candidate NVG-291 NervGen Pharma Corp. announced that all subjects (male, premenopausal and post-menopausal females) in the Phase 1 clinical trial of the Company's proprietary lead compound, NVG-291, have completed dosing. The Company now plans to initiate a Phase 1b/2a clinical trial of NVG-291 in individuals with spinal cord injury in Third Quarter 2023. Based on the encouraging results from preclinical studies, the Company plans to evaluate the efficacy of NVG- 291 versus placebo in two cohorts: individuals with a chronic injury (1-10 years post-injury) and individuals with a subacute injury (10-49 days post-injury). In preclinical studies of spinal cord injury, NervGen's NVG-291 has been demonstrated to promote neural repair mechanisms, including axonal regeneration, remyelination and plasticity.