NervGen Pharma Reports 2024 Year-End Financial Results and Provides Business Updates
NervGen Pharma (NGENF) has reported its 2024 year-end financial results and key developments. The company completed enrollment in the chronic cohort of its Phase 1b/2a clinical trial for NVG-291 in spinal cord injury (SCI), with topline data expected in early June 2025. The company also initiated enrollment in the subacute cohort and received FDA approval for an expanded access protocol.
Financial highlights include a cash position of $17.3 million as of December 31, 2024, bolstered by a $23 million bought deal financing. R&D expenses increased to $15.7 million from $8.0 million in 2023, while G&A expenses decreased to $9.2 million from $9.7 million. The company reported a net loss of $24.0 million ($0.36 per share) for 2024.
The company's pipeline candidate NVG-300 showed promising preclinical results in ischemic stroke and SCI models, demonstrating decreased lesion volume and improved functional outcomes.
NervGen Pharma (NGENF) ha riportato i risultati finanziari di fine anno 2024 e i principali sviluppi. L'azienda ha completato l'arruolamento nel gruppo cronico del suo trial clinico di fase 1b/2a per NVG-291 in caso di lesioni del midollo spinale (SCI), con i dati preliminari attesi all'inizio di giugno 2025. L'azienda ha inoltre avviato l'arruolamento nel gruppo subacuto e ha ricevuto l'approvazione della FDA per un protocollo di accesso espanso.
I punti salienti finanziari includono una posizione di cassa di 17,3 milioni di dollari al 31 dicembre 2024, rafforzata da un finanziamento di 23 milioni di dollari tramite un accordo di acquisto. Le spese per R&S sono aumentate a 15,7 milioni di dollari rispetto a 8,0 milioni nel 2023, mentre le spese generali e amministrative sono diminuite a 9,2 milioni di dollari rispetto a 9,7 milioni. L'azienda ha riportato una perdita netta di 24,0 milioni di dollari (0,36 dollari per azione) per il 2024.
Il candidato in pipeline dell'azienda NVG-300 ha mostrato risultati preclinici promettenti in modelli di ictus ischemico e SCI, dimostrando una riduzione del volume delle lesioni e un miglioramento degli esiti funzionali.
NervGen Pharma (NGENF) ha informado sobre sus resultados financieros de fin de año 2024 y los desarrollos clave. La compañía completó la inscripción en el grupo crónico de su ensayo clínico de fase 1b/2a para NVG-291 en lesiones de la médula espinal (SCI), con datos preliminares esperados para principios de junio de 2025. La empresa también inició la inscripción en el grupo subagudo y recibió la aprobación de la FDA para un protocolo de acceso expandido.
Los aspectos financieros destacados incluyen una posición de efectivo de 17,3 millones de dólares al 31 de diciembre de 2024, reforzada por un financiamiento de 23 millones de dólares a través de un acuerdo de compra. Los gastos de I+D aumentaron a 15,7 millones de dólares desde 8,0 millones en 2023, mientras que los gastos generales y administrativos disminuyeron a 9,2 millones de dólares desde 9,7 millones. La compañía reportó una pérdida neta de 24,0 millones de dólares (0,36 dólares por acción) para 2024.
El candidato en desarrollo de la compañía NVG-300 mostró resultados preclínicos prometedores en modelos de accidente cerebrovascular isquémico y SCI, demostrando una disminución en el volumen de lesiones y una mejora en los resultados funcionales.
NervGen Pharma (NGENF)는 2024년 연말 재무 결과 및 주요 개발 사항을 보고했습니다. 이 회사는 척수 손상(SCI)에 대한 NVG-291의 1b/2a 임상 시험의 만성 집단에 대한 등록을 완료했으며, 초기 데이터는 2025년 6월 초에 예상됩니다. 회사는 또한 아급성 집단에 대한 등록을 시작했으며, 확대 접근 프로토콜에 대한 FDA 승인을 받았습니다.
재무 하이라이트로는 2024년 12월 31일 기준 1,730만 달러의 현금 보유액이 있으며, 2,300만 달러의 매입 거래 자금으로 강화되었습니다. 연구개발(R&D) 비용은 2023년 800만 달러에서 1,570만 달러로 증가했으며, 일반 관리(G&A) 비용은 970만 달러에서 920만 달러로 감소했습니다. 회사는 2024년 동안 2,400만 달러 (주당 0.36달러)의 순손실을 보고했습니다.
회사의 파이프라인 후보인 NVG-300은 허혈성 뇌졸중 및 SCI 모델에서 유망한 전임상 결과를 보여주었으며, 병변의 부피 감소와 기능적 결과의 개선을 입증했습니다.
NervGen Pharma (NGENF) a rapporté ses résultats financiers de fin d'année 2024 ainsi que ses développements clés. La société a terminé le recrutement dans la cohorte chronique de son essai clinique de phase 1b/2a pour NVG-291 dans le cadre des lésions de la moelle épinière (SCI), avec des données préliminaires attendues début juin 2025. L'entreprise a également lancé le recrutement dans la cohorte subaiguë et a reçu l'approbation de la FDA pour un protocole d'accès élargi.
Les faits saillants financiers incluent une position de trésorerie de 17,3 millions de dollars au 31 décembre 2024, renforcée par un financement de 23 millions de dollars par le biais d'un accord d'achat. Les dépenses de R&D ont augmenté à 15,7 millions de dollars contre 8,0 millions en 2023, tandis que les dépenses générales et administratives ont diminué à 9,2 millions de dollars contre 9,7 millions. L'entreprise a signalé une perte nette de 24,0 millions de dollars (0,36 dollar par action) pour 2024.
Le candidat de pipeline de l'entreprise NVG-300 a montré des résultats précliniques prometteurs dans des modèles d'accident vasculaire cérébral ischémique et de SCI, démontrant une diminution du volume des lésions et une amélioration des résultats fonctionnels.
NervGen Pharma (NGENF) hat seine finanziellen Ergebnisse zum Jahresende 2024 sowie wichtige Entwicklungen berichtet. Das Unternehmen hat die Rekrutierung in der chronischen Kohorte seiner Phase 1b/2a-Studie für NVG-291 bei Rückenmarksverletzungen (SCI) abgeschlossen, wobei die vorläufigen Daten Anfang Juni 2025 erwartet werden. Das Unternehmen hat außerdem die Rekrutierung in der subakuten Kohorte gestartet und die FDA-Zulassung für ein erweitertes Zugangsprotokoll erhalten.
Zu den finanziellen Highlights gehören eine Liquiditätsposition von 17,3 Millionen Dollar zum 31. Dezember 2024, unterstützt durch eine 23 Millionen Dollar große Kaufvereinbarung. Die F&E-Ausgaben stiegen auf 15,7 Millionen Dollar von 8,0 Millionen im Jahr 2023, während die allgemeinen und administrativen Ausgaben auf 9,2 Millionen Dollar von 9,7 Millionen sanken. Das Unternehmen berichtete für 2024 von einem Nettoverlust von 24,0 Millionen Dollar (0,36 Dollar pro Aktie).
Der Pipeline-Kandidat des Unternehmens NVG-300 zeigte vielversprechende präklinische Ergebnisse in Modellen für ischämischen Schlaganfall und SCI und demonstrierte eine Verringerung des Läsionsvolumens sowie verbesserte funktionale Ergebnisse.
- Completed enrollment in chronic cohort of Phase 1b/2a trial with data expected June 2025
- Secured $23 million through bought deal financing
- FDA approved expanded access protocol for NVG-291
- Promising preclinical results for NVG-300 in stroke and SCI models
- Successfully initiated enrollment in subacute cohort
- Net loss increased to $24.0 million in 2024
- R&D expenses nearly doubled to $15.7 million
- Current cash runway only extends through Q3 2025
- Paused preclinical validation in ALS indication
- Completed enrollment in the chronic cohort and commenced enrollment in the subacute cohort of its Phase 1b/2a clinical trial for lead drug candidate, NVG-291, in spinal cord injury (SCI)
- Initiated an expanded access protocol for NVG-291 for individuals with SCI who have participated in a NervGen clinical trial and meet specific eligibility criteria
- Pipeline candidate NVG-300 showing promising activity in preclinical models of ischemic stroke and SCI
Vancouver, British Columbia--(Newsfile Corp. - April 3, 2025) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company dedicated to developing neurorestorative therapeutics, today reported its financial and operational results for the full year ended December 31, 2024.
"2024 was a very productive year for NervGen as we advanced the clinical development of our lead candidate, NVG-291, in spinal cord injury and delivered on key research activities and business milestones," said Mike Kelly, President and Chief Executive Officer of NervGen Pharma. "Most notably, we completed enrollment in the chronic cohort of our Phase 1b/2a clinical study of NVG-291 for individuals with SCI and anticipate a topline data readout for this cohort in early June 2025. We also received Institutional Review Board approval for an amendment to the subacute cohort of our Phase 1b/2a clinical trial and initiated enrollment. This important proof-of-concept study is aimed at demonstrating for the first time the potential of NVG-291 in enabling repair of nervous system damage in individuals with spinal cord injury.
"Importantly, we expect that the net proceeds from our
Earlier this week, NervGen also reported that the FDA informed the company that an expanded access protocol for NVG-291 may proceed. The protocol submission was in response to a request from a physician for expanded access to NVG-291 for a patient who participated in the chronic cohort of the Phase 1b/2a clinical trial.
In addition, preclinical studies of NVG-300 in ischemic stroke and SCI, initiated during 2024, showed promising initial results, suggesting further investigation is warranted. Key preclinical findings in ischemic stroke and SCI include:
- NVG-300-R, the rodent variant of NVG-300, in ischemic stroke: Preclinical data from a rat model of ischemic stroke showed rapid decrease in the ischemic lesion volume in animals treated with NVG-300-R. Significant effects of NVG-300-R also included improved performance in the functional memory and spatial recognition (Y-maze), and locomotor function (horizontal ladder) tests.
- NVG-300-R and NVG-300 in SCI: In the preclinical model of SCI caused by thoracic contusion, animals treated with NVG-300-R or NVG-300 showed improvement in gait quality assessed by NeuroCube®, an in vivo AI platform that uses computer vision combined with bioinformatics to perform objective multivariate analysis of gait patterns.
"The preclinical evidence of NVG-300 and NVG-300-R activity in animal models of ischemic stroke and SCI is encouraging," said Matvey Lukashev, Ph.D., Vice President of Research and Preclinical Development of NervGen Pharma. "Taken together, the results of this latest set of in vivo studies offer further preclinical validation of NVG-300. Preclinical validation in amyotrophic lateral sclerosis (ALS) will be paused at this time."
Full Year and Recent Business Highlights
- We advanced the clinical development of NVG-291:
- In February 2024, we announced that we are developing plans to initiate a new study in which subjects completing the current trial who received placebo, would have the option to receive open-label NVG-291 under a separate protocol. We plan to initiate this open-label study, provided that an efficacy signal is observed in the chronic cohort, contingent upon protocol approval by the FDA as well as the study's Institutional Review Board.
- At several scientific conferences during 2024, Daniel Mikol, M.D., Ph.D., Chief Medical Officer of NervGen Pharma, presented the trial design, the rationale for evaluating clinical outcome measures in addition to electrophysiological measures as biomarkers of efficacy, and provided an update on the baseline demographic and clinical characteristics of randomized subjects.
- At year end, we announced the completion of enrollment in the chronic cohort of our Phase 1b/2a clinical trial of NVG-291 in individuals with SCI; topline data from the chronic cohort is expected in early June 2025. The company also received Institutional Review Board approval for an amendment to its Phase 1b/2a clinical trial protocol and initiated screening of subjects for the subacute cohort. The enrollment and dosing of the first subject in the subacute cohort was announced in early February 2025 and enrollment continues.
- Subsequent to year-end, on March 31, 2025, we announced the initiation of an expanded access policy to allow treatment use of the investigational product NVG-291 for those individuals with SCI who have participated in NervGen clinical trials and meet specific eligibility criteria. We received a request from a physician for expanded access to NVG-291 for a subject who participated in the chronic cohort of the Phase 1b/2a clinical trial. After we submitted an expanded access protocol for NVG-291 to the FDA, the FDA informed us that the study could proceed.
- We advanced our research activities related to our drug candidates:
- During 2024, we initiated preclinical test-of-concept evaluation of a potential second development candidate, NVG-300, in models of ischemic stroke, ALS and SCI. In addition, we initiated studies to further elucidate the mechanism of NVG-291 therapeutic action.
- We improved our position with equity proceeds of over
$23 million and established an ATM program to fund our ongoing clinical trial:- On March 28, 2024, we announced the closing of the previously announced public offering, including the full exercise of the underwriters' over-allotment option for aggregate gross proceeds of
$23 million . Pursuant to the offering, the underwriters purchased, on a bought deal basis, and we issued 9,792,250 units at a price of$2.35 per unit. Each unit was comprised of one common share and one-half of one common share purchase warrant. Each whole warrant is exercisable to acquire one common share for a period of 36 months following the closing of the offering at an exercise price of$3.00 per warrant share. In connection with the offering, we issued an aggregate of 170,127 broker warrants and paid a cash commission of$1.1 million to the underwriters and incurred approximately$0.54 million in other share issue costs related to legal and listing fees.
- On March 28, 2024, we announced the closing of the previously announced public offering, including the full exercise of the underwriters' over-allotment option for aggregate gross proceeds of
- On December 20, 2024, we announced the establishment of an ATM equity program that allows us to issue and sell common shares to the public from time to time through an agent at our discretion and subject to regulatory requirements. We initiated sales under the ATM in January 2025.
- During the year, we continued to add expertise to our team with the following additions and appointments:
- In July 2024, Mr. Neil Klompas was appointed to our Board of Directors. Mr. Klompas is an experienced life sciences and healthcare sector executive and board member. He is currently the President and Chief Executive Officer, and a member of the Board of Directors, of Augurex Life Sciences Corp. Prior to Augurex, he served as Chief Financial Officer, and later President and Chief Operating Officer of Zymeworks Inc. During his time with the company, he oversaw finance and operations, including leading the execution 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 M&A Transaction Services practice in Princeton, NJ, and with KPMG LLP in the life sciences assurance practice based in Vancouver. He holds a BSc in Microbiology & Immunology from the University of British Columbia and is a Chartered Professional Accountant.
- During the year, we also added senior level talent to oversee our clinical operations, program management, regulatory affairs, technical operations and CMC, and corporate development.
Full Year 2024 Financial Highlights
- Cash and Investments: NervGen had cash and investments of
$17.3 million as of December 31, 2024, compared to$11.7 million as of December 31, 2023. Our cash balance was improved during the year by the net proceeds of the March 2024 bought deal financing and approximately$1.4 million in proceeds from the exercise of stock options and warrants during the year. The net cash burn for the year ended December 31, 2024, from operating activities was approximately$16.8 million .
- R&D Expenses: Research and development expenses were
$15.7 million for the year ended December 31, 2024, compared to$8.0 million for the year ended December 31, 2023. The increase in the year ended December 31, 2024, is primarily related to clinical spend associated with a full year of Phase 1b/2a clinical trial activity, an increase in preclinical translational research, an increase in drug manufacturing costs, and an increase in headcount related spend within the R&D function. In the year ended December 31, 2023, clinical study costs were comparatively lower as we completed dosing in our Phase 1 clinical trial and we received grant funding that partially offset the costs of our Phase 1b/2a clinical trial that commenced in the second half of 2023.
- G&A Expenses: General and administrative expenses were
$9.2 million for the year ended December 31, 2024, compared to$9.7 million for the year ended December 31, 2023. The decrease was primarily due to non-cash stock-based compensation expenses due to the hiring of our new President & CEO and other employees and consultants in the prior comparative period, and the timing of the related vesting.
- Net Loss: For the year ended December 31, 2024, net loss was
$24.0 million , or$0.36 per basic and diluted common share. The net loss for the year included$6.3 million of non-cash expenses pertaining to amortization, stock-based compensation, unrealized foreign exchange and the fair value adjustment of the warrant derivative. For the year ended December 31, 2023, net loss was$22.4 million , or$0.38 per basic and diluted common share which included$11.3 million of non-cash expenses pertaining to amortization, stock-based compensation, unrealized foreign exchange and the fair value adjustment of the warrant derivative.
The company also announces that it has engaged Sam Brown Healthcare Communications, a Blue Matter Company (Sam Brown), a leading integrated communications and public relations agency focused on corporate, clinical and commercial communications for the life sciences industry. Sam Brown will provide media and public relations and related services for the company and is engaged for an initial period of nine months that will continue thereafter on a month-to-month basis unless terminated by either party with 30 days' notice. It is expected that the cash compensation that is paid in the first twelve months will not exceed US
About Phase 1b/2a Trial
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 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. More information about participation in the subacute study is available at www.connectscistudy.com.
About NVG-291
NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic peptide targeting nervous system repair. NVG-291's technology was licensed from Case Western Reserve University and is based on academic studies demonstrating the preclinical efficacy of NVG-291-R, the rodent prototype of NVG-291, in animal models of spinal cord injury. Effects of NVG-291-R reported in multiple independent academic studies include the promotion of neuroplasticity, remyelination, anti-inflammatory polarization of microglia, and functional improvement in preclinical models of spinal cord injury, stroke, dementia, and peripheral nervous system injury. NVG-291 has received Fast Track designation in spinal cord injury from the FDA.
About NVG-300
The discovery of NVG-300, a new biological molecule, is the result of a research effort initiated by NervGen in 2022, leveraging NervGen's extensive internal expertise and the evolving scientific understanding of the mechanisms involved in nervous system repair. NVG-300 is the first of what NervGen believes will be a pipeline of new molecules addressing high unmet need neurologic indications. NVG-300 product and process development have progressed to successfully establish manufacturability and feasibility of high concentration liquid formulation to enable self-administration of the product in a prefilled syringe format. NVG-300 will be developed under the Biologics License Application regulatory framework that provides 12 years of market exclusivity post-approval, and its composition of matter intellectual property protection is expected to extend beyond 2040.
About Ischemic Stroke
Stroke is the leading cause of death and severe disability worldwide, significantly diminishing the quality of life for many affected individuals. Globally, nearly 17 million people experience a stroke each year, with over two million cases annually in the United States, Europe, and Japan combined. The most prevalent type of stroke, ischemic stroke, occurs when a blockage in the brain's blood flow deprives it of oxygen and nutrients, often leading to long-term or permanent neurological damage. Unfortunately, treatment options for ischemic stroke are limited. Current therapies, such as the administration of the clot-dissolving agent tissue plasminogen activator or surgical clot removal, must generally be performed within a few hours of stroke onset.
About Sam Brown Healthcare Communications
A Blue Matter company, Sam Brown Healthcare Communications is a leading corporate, clinical, and commercial communications agency for the life sciences industry. Sam Brown provides broad strategic communications services to a wide range of biotechnology, biopharmaceutical and venture capital companies whose cutting-edge science and innovation impact human health. For more information, visit www.sambrown.com.
About NervGen
NervGen (TSXV: NGEN) (OTCQB: NGENF) is a clinical-stage biotech company dedicated to developing innovative treatments to promote nervous system repair in settings of neurotrauma and neurologic disease. The company is testing the clinical efficacy of its lead molecule, NVG-291, in a Phase 1b/2a clinical trial in spinal cord injury and has initiated preclinical evaluation of a new development candidate, NVG-300, in models of ischemic stroke and spinal cord injury. For more information, visit www.nervgen.com and follow NervGen on X, LinkedIn, and Facebook for the latest news on the company.
Contacts
Huitt Tracey, Investor Relations
htracey@nervgen.com
604.537.2094
Bill Adams, Chief Financial Officer
info@nervgen.com
778.731.1711
Christy Curran
Sam Brown Healthcare Communications
christycurran@sambrown.com
615.414.8668
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Cautionary Note Regarding 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 and information 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 objectives, planned clinical endpoints, timing, expected rate of enrollment, and timing of data readout and study design of our Phase 1b/2a clinical trial of NVG-291 in individuals with spinal cord injury; the potential access to NVG-291 through the company's expanded access policy; our belief that the net proceeds from our bought deal financing, along with our current working capital and anticipated proceeds from our ATM program is sufficient to fund our planned research and development activities through Q3 2025; the development plans, timelines, expected benefits, and prospective target indications for NVG-300; the expected contributions from the added senior level talent and engagement of Sam Brown; the expected compensation payable to Sam Brown in the next twelve months; the receipt of the milestone-based grant payments; and the creation of neurorestorative 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, we have relied on various assumptions, including, but not limited to: our ability to obtain future funding on favourable terms or at all; the accuracy of our financial projections; obtaining positive results in our clinical and other trials; our ability to obtain necessary regulatory approvals; our ability to arrange for the manufacturing of our product candidates and technologies; and general business, market and economic conditions.
Many factors could cause our 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 we have no intention and undertake 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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