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NervGen Pharma Corp (symbol: NGENF) is a clinical-stage biotech company focused on developing cutting-edge solutions for treating nervous system damage. Their lead drug candidate, NVG-291, is currently in a Phase 1b/2a clinical trial, targeting spinal cord injury as the initial indication. The company recently reported its financial and operational results, highlighting progress in recruitment for their clinical study and receiving Fast Track designation from the FDA. With a strong focus on innovative treatments and dedicated research efforts, NervGen is committed to enabling the nervous system to repair itself in cases of injury or disease.
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company focused on neurorestorative therapeutics, has announced the granting of 627,200 incentive stock options. The options were distributed to company employees, with 505,200 options allocated to Officers. These options are exercisable at $2.97 per share with a 10-year duration and vest equally every six months over a two-year period. The grants comply with TSX Venture Exchange policies and the company's stock option plan.
NervGen Pharma has announced the dosing of its first subject in the subacute cohort of its Phase 1b/2a clinical trial for NVG-291, targeting spinal cord injury (SCI) treatment. The trial (NCT05965700) is designed as a proof-of-concept, double-blind, randomized placebo-controlled study.
The company has implemented protocol amendments for the subacute cohort, including revising the timing window to 20-90 days post-injury and reducing the number of visits and assessments to decrease participant burden. The trial evaluates efficacy in two separate cohorts: chronic and subacute cervical spinal cord injury.
Results for the chronic cohort, which has completed enrollment, are expected in Q2 2025. The company plans to continue enrollment in the subacute cohort throughout 2025.
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company focused on neurorestorative therapeutics, has announced its participation in the upcoming Oppenheimer 35th Annual Healthcare Life Sciences Conference. The company's President & CEO, Mike Kelly, will engage in a fireside chat on February 11, 2025, at 8:40 a.m. EST.
The conference, scheduled for February 11-12, 2025, will be held in a virtual format. NervGen's management team will be available for one-on-one virtual meetings with investors throughout the conference. A webcast of the presentation will be made available and archived for later viewing.
NervGen Pharma has completed enrollment of 20 subjects in the chronic cohort of its Phase 1b/2a clinical trial for NVG-291, its lead candidate for spinal cord injury (SCI) treatment. The company expects to release topline data in Q2 2025 after completing data collection, review, database lock, unblinding, and analysis.
The company has also received IRB approval for a protocol amendment and begun screening subjects for the subacute cohort. The trial (NCT05965700) is designed as a proof-of-concept, double-blind, randomized placebo-controlled study.
Management believes their experience from recruiting the chronic cohort, combined with the recently approved protocol amendment, will improve the recruitment process for the subacute cohort while reducing the burden on participants.
NervGen Pharma (TSXV: NGEN) (OTCQB: NGENF) has established an at-the-market equity program (ATM Program) allowing the company to issue and sell common shares through Stifel Nicolaus Canada Inc. The program has a limit of up to C$30 million in common shares, with sales occurring at prevailing market prices on the TSX Venture Exchange or other recognized marketplaces in Canada.
The ATM Program will run until December 19, 2026, unless terminated earlier. The company plans to use the net proceeds for general corporate purposes, including ongoing operations, working capital, research and development, intellectual property development, preclinical and clinical expenses, and potential future acquisitions. The program provides NervGen with enhanced flexibility for future additional financing needs.
NervGen Pharma reported Q3 2024 financial results, highlighting the approaching completion of target enrollment in the chronic cohort of their Phase 1b/2a clinical trial for NVG-291 in spinal cord injury. The company initiated preclinical studies for NVG-300 in ischemic stroke, ALS, and SCI. Financial results show cash position of $21.0 million as of September 30, 2024, with Q3 R&D expenses of $4.4 million and G&A expenses of $2.8 million. Net loss for Q3 was $5.2 million ($0.07 per share).
NervGen Pharma (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company focusing on neurorestorative therapeutics, has announced its participation in the Stifel 2024 Healthcare Conference. CEO Mike Kelly will lead a fireside chat on November 18, 2024, at 10:20 a.m. EST. The conference will be held at the Lotte New York Palace Hotel from November 18-19, 2024. Management will be available for one-on-one investor meetings during the event, and a webcast of the presentation will be available for replay.
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF) has announced that target enrollment for the chronic cohort in its Phase 1b/2a clinical trial of NVG-291 for spinal cord injury (SCI) is nearing completion. The study (NCT05965700) is a proof-of-concept, double-blind, randomized placebo-controlled trial. Mike Kelly, NervGen's President & CEO, expressed excitement about the progress but noted challenges in forecasting enrollment due to various factors and the study's novel design.
The company remains confident in advancing NVG-291 and will provide updates when enrollment is completed and when topline data is expected. NervGen plans to allow all subjects who have started the screening process when the 20-subject target is reached to enroll if they meet the criteria, potentially resulting in more than 20 subjects in the chronic cohort.
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company, announced that its Chief Medical Officer, Daniel Mikol, MD, Ph.D., will present at the Unite 2 Fight Paralysis (U2FP) 19th Annual Science & Advocacy Symposium on September 27-28, 2024, in Atlanta, Georgia.
Dr. Mikol's presentation, titled 'Clinical Trials in Spinal Cord Injury ... Lost in Translation?', will be delivered during Session 6 on Saturday, September 28, from 11:00 a.m. to 11:20 a.m. EDT at the Atlanta Marriott Marquis. He will discuss the challenges of translating results from animal models to human clinical trials for spinal cord injury (SCI).
The U2FP Symposium is a significant event that gathers research scientists, clinicians, investors, SCI survivors, and family members to promote knowledge, collaboration, and empowerment for stakeholders dedicated to finding a cure for SCI.
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company, announced that its Chief Medical Officer, Dr. Daniel Mikol, will present at the 63rd International Spinal Cord Society (ISCoS) Annual Scientific Meeting in Antwerp, Belgium, on September 23, 2024. Dr. Mikol will provide a clinical trial update on the Phase 1b/2a study of NVG-291 in individuals with subacute or chronic spinal cord injury (SCI).
The presentation will cover the trial design, rationale for evaluating clinical and electrophysiological measures, and baseline characteristics of randomized subjects. NVG-291 has shown promise in preclinical studies for promoting functional recovery through neural repair mechanisms. The company hopes that the trial results will demonstrate the potential of NVG-291 to enable neural repair in SCI patients and support further investigation.
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