NurExone Reports Third Quarter 2024 Financial Results and Provides Corporate Update
NurExone Biologic reported its Q3 2024 financial results with a net loss of US$1.25 million, compared to US$1.16 million in Q3 2023. R&D expenses increased to US$0.50 million from US$0.40 million year-over-year, while G&A expenses rose slightly to US$0.78 million. The company's cash position strengthened to US$2.52 million as of September 30, 2024, up from US$0.54 million at end-2023, primarily due to private placements and warrant exercises generating approximately US$5.98 million. The company received European Medicines Agency's Orphan Medicinal Product Designation for its ExoPTEN therapy for acute spinal cord injury treatment.
NurExone Biologic ha riportato i risultati finanziari per il terzo trimestre del 2024 con una perdita netta di 1,25 milioni di dollari, rispetto a 1,16 milioni di dollari nel terzo trimestre del 2023. Le spese per ricerca e sviluppo sono aumentate a 0,50 milioni di dollari da 0,40 milioni di dollari rispetto all'anno precedente, mentre le spese generali e amministrative sono aumentate leggermente a 0,78 milioni di dollari. La posizione di liquidità dell'azienda si è rafforzata a 2,52 milioni di dollari al 30 settembre 2024, in aumento rispetto a 0,54 milioni di dollari a fine 2023, principalmente grazie a collocamenti privati e esercizi di warrant che hanno generato circa 5,98 milioni di dollari. L'azienda ha ricevuto la designazione di Prodotto Medicinale Orfano dall'Agenzia Europea dei Medicinali per la sua terapia ExoPTEN per il trattamento delle lesioni acute del midollo spinale.
NurExone Biologic reportó sus resultados financieros del tercer trimestre de 2024 con una pérdida neta de 1,25 millones de dólares, en comparación con 1,16 millones de dólares en el tercer trimestre de 2023. Los gastos en I+D aumentaron a 0,50 millones de dólares desde 0,40 millones de dólares en el año anterior, mientras que los gastos generales y administrativos subieron ligeramente a 0,78 millones de dólares. La posición de efectivo de la empresa se fortaleció a 2,52 millones de dólares al 30 de septiembre de 2024, comparado con 0,54 millones de dólares a finales de 2023, principalmente debido a colocaciones privadas y ejercicios de opciones que generaron aproximadamente 5,98 millones de dólares. La empresa recibió la designación de Producto Medicinal Huérfano de la Agencia Europea de Medicamentos para su terapia ExoPTEN para el tratamiento de lesiones agudas de la médula espinal.
NurExone Biologic은 2024년 3분기 재무 결과를 보고하며, 순손실이 125만 달러로 2023년 3분기 116만 달러에 비해 증가했습니다. 연구 개발 비용이 전년 대비 40만 달러에서 50만 달러로 증가한 반면, 일반 및 관리 비용은 소폭 증가하여 78만 달러에 이르렀습니다. 회사의 현금 보유액은 2024년 9월 30일 기준으로 252만 달러로, 2023년 말 54만 달러에서 증가했으며, 이는 주로 사모 배정 및 보증 행사로 약 598만 달러를 발생시킨 결과입니다. 이 회사는 급성 척수 손상 치료를 위한 ExoPTEN 요법에 대해 유럽 의약청의 희귀 의약품 지정에 대한 승인을 받았습니다.
NurExone Biologic a publié ses résultats financiers du troisième trimestre 2024, faisant état d'une perte nette de 1,25 million de dollars, contre 1,16 million de dollars au troisième trimestre 2023. Les dépenses de recherche et développement ont augmenté à 0,50 million de dollars, contre 0,40 million de dollars l'année précédente, tandis que les dépenses générales et administratives ont légèrement augmenté à 0,78 million de dollars. La position de trésorerie de l'entreprise s'est renforcée à 2,52 millions de dollars au 30 septembre 2024, contre 0,54 million de dollars fin 2023, principalement grâce à des placements privés et à l'exercice de bons qui ont généré environ 5,98 millions de dollars. L'entreprise a reçu la désignation de Produit Médical Orphelin de l'Agence Européenne des Médicaments pour sa thérapie ExoPTEN destinée au traitement des lésions aiguës de la moelle épinière.
NurExone Biologic berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 mit einem Nettoverlust von 1,25 Millionen US-Dollar, im Vergleich zu 1,16 Millionen US-Dollar im dritten Quartal 2023. Die F&E-Ausgaben stiegen im Jahresvergleich von 0,40 Millionen US-Dollar auf 0,50 Millionen US-Dollar, während die allgemeinen und Verwaltungskosten leicht auf 0,78 Millionen US-Dollar anstiegen. Die Liquiditätslage des Unternehmens verbesserte sich bis zum 30. September 2024 auf 2,52 Millionen US-Dollar, ein Anstieg von 0,54 Millionen US-Dollar Ende 2023, hauptsächlich aufgrund von Privatplatzierungen und der Ausübung von Optionsscheinen, die etwa 5,98 Millionen US-Dollar generierten. Das Unternehmen erhielt die Zulassung als Orphan Medicinal Product von der Europäischen Arzneimittel-Agentur für seine ExoPTEN-Therapie zur Behandlung von akuten Rückenmarkverletzungen.
- Improved cash position to US$2.52M from US$0.54M at end-2023
- Successful fundraising through private placements and warrant exercises totaling US$5.98M
- Obtained European Medicines Agency's Orphan Medicinal Product Designation for ExoPTEN therapy
- Working capital improved to US$2.39M from US$0.07M at end-2023
- Net loss increased to US$1.25M from US$1.16M in Q3 2023
- R&D expenses increased 25% to US$0.50M
- G&A expenses rose to US$0.78M
- Accumulated deficit increased to US$17.55M from US$14.06M
TORONTO and HAIFA, Israel, Nov. 27, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company developing regenerative medicine therapies, is pleased to announce its financial and operational results for the three and nine months ended September 30, 2024, the highlights of which are included in this news release. The Company’s complete set of condensed interim consolidated financial statements for the three and nine months ended September 30, 2024, and accompanying management’s discussion and analysis for the period can be accessed by visiting the Company’s website at www.nurexone.com and its profile page on SEDAR+ at www.sedarplus.ca.
Key Business Highlights
- In July 2024 and September 2024, the Company generated gross proceeds of C
$143,172.05 t hrough the issuance of 409,063 common shares upon the exercise of warrants at price of C$0.35 per common share which were issued in the Company’s January 2024 private placement. - On August 1, 2024, the Company engaged Allele Capital Partners, LLC, an independently owned capital markets advisory firm based in the United States, for investor relations services.
- On September 26, 2024, the Company closed the first tranche of its non-brokered private placement through the issuance of 2,927,541 units at a price of C
$0.55 per unit, resulting in aggregate gross proceeds of C$1,610,147.55 . Each unit consisted of one common share and one common share purchase warrant, with each warrant entitling the holder thereof to purchase one additional common share at a price of C$0.70 per common share for a period of 36 months, subject to acceleration, as more particularly set out in the Company’s September 26, 2024 press release. - On November 1, 2024, the Company closed the final tranche of its non-brokered private placement through the issuance of 231,818 units at a price of C
$0.55 per unit, resulting in aggregate gross proceeds of C$127,499.90 . - On November 1, 2024, the Company engaged Independent Trading Group and Oak Hill Financial Inc. to provide market-making, business, and capital markets advisory services.
- On November 13, 2024, the Company announced that the European Medicines Agency granted Orphan Medicinal Product Designation for the Company’s ExoPTEN therapy, marking a significant step towards making this potential treatment available for acute spinal cord injury patients across Europe.
Third Quarter Fiscal 2024 Financial Results
- Research and development expenses, net, were US
$0.50 million in the third quarter of 2024, compared to US$0.40 million in the same quarter in 2023. The increase was primarily due to higher subcontractor and materials expenses of US$0.15 million , partially offset by a governmental grant receipt of US$0.05 million . - General and administrative expenses were US
$0.78 million in the third quarter of 2024, compared to US$0.76 million in the same period in 2023. The rise was mainly attributed to an increase in non-cash costs associated with granted stock options of US$0.17 , partially offset by professional and legal services expenses of US$0.15 million . - Finance income was US
$0.04 million in the third quarter of 2024, compared to finance income of US$0.01 million in the same period in 2023, primarily due to income from bank interest and financing exchange rate adjustments. - The net loss for the third quarter of 2024 was US
$1.25 million , compared to a net loss of US$1.16 million in the same quarter of 2023.
As of September 30, 2024, the Company held cash and cash equivalents totaling US
As of September 30, 2024, the Company had an accumulated deficit of US
Eran Ovadya, NurExone’s Chief Financial Officer, stated: “Our latest financial performance reflects our commitment to advancing ExoPTEN to clinical trials, while streamlining operations and optimizing our business strategy to drive sustainable growth and secure long-term success.”
Growth Outlook for 2024-2025
According to Chief Executive Officer Dr. Lior Shaltiel, “NurExone is making significant strides on the path towards human trials, including the receipt of Orphan Drug Status for ExoPTEN in Europe, the successful transfer of key manufacturing processes to a Good Manufacturing Practice-compliant facility – an essential step toward clinical trials and commercial production. These efforts are being strengthened by our consultant, Dr. Yona Geffen, a highly respected expert who has successfully guided companies through the regulatory landscape to commercialization. In parallel, the Company is collaborating with the Goldschleger Eye Institute at Sheba Medical Center, ranked by Newsweek as one of the top ten hospitals in the world, to study ExoPTEN for its potential in a second commercial market, the multi-billion-dollar glaucoma market(1), with promising preliminary results.”
About NurExone Biologic Inc.
NurExone Biologic Inc. is a TSX Venture Exchange (“TSXV”) listed pharmaceutical company that is developing a platform for biologically-guided exosome-based therapies to be delivered, non-invasively, to patients who have suffered Central Nervous System injuries. The Company’s first product, ExoPTEN for acute spinal cord injury, was proven to recover motor function in
For additional information, please visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.
For more information, please contact:
Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com
Oak Hill Financial Inc.
2 Bloor Street, Suite 2900
Toronto, Ontario M4W 3E2
Investor Relations - Canada
Phone: +1-647-479-5803
Email: info@oakhillfinancial.ca
Dr. Eva Reuter
Investment Relation - Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu
Allele Capital Partners
Investment Relation - US
Phone: +1 978-857-5075
Email: aeriksen@allelecapital.com
FORWARD-LOOKING STATEMENTS
This press release contains certain “forward-looking statements”, that reflect the Company’s current expectations and projections about its future results. Wherever possible, words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or “potential” or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating to the receipt of the Orphan Medicinal Product Designation having the intended benefits and incentives on the Company and its business as set out herein; the potential glaucoma market; the Company having adequate financing through the end of the year and well into 2025; the Company entering the European market and bringing its products to patients across Europe; the Company’s latest financial performance positioning it for sustained growth and long-term success; the Company making significant strides on the path towards human trials with assistance from Dr. Yona Geffen; the Company collaborating with the Goldschleger Eye Institute at Sheba Medical Center to study ExoPTEN for its potential in a second commercial market, the multi-billion-dollar glaucoma market, with promising preliminary results; and the NurExone platform technology offering novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.
These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including the general business and economic conditions of the industries and countries in which we operate; the general market conditions; the ability to secure additional funding; partnerships having their intended impact on the Company and its business; patents safeguarding NurExone’s technology; the Company’s drug products having its intended benefits and effects; the Company making progress through new partnerships and technologies to move towards commercialization of their products; the Company’s intellectual property and technology being novel and inventive; the intellectual property having the intended impact on the Company and its business; exosomes becoming an ideal and natural choice for drug delivery; the Company making advancements in the manufacturing process of exosomes; exosomes holding immense promise for regenerative medicine; the Company’s preclinical and clinical testing will yield their intended results; the Company will proceed to clinical trials on the timelines setout herein; the Company will have sufficient funding for its operations; the Company will enter into new partnerships and/or licensing agreements; the receipt of the Orphan Medicinal Product Designation having the intended benefits and incentives on the Company and its business as set out herein; the Company will enter the European market and bring its products to patients across Europe; the Company being able to make significant strides on the path towards human trials with assistance from Dr. Yona Geffen; the Company being able to collaborate with the Goldschleger Eye Institute at Sheba Medical Center to study ExoPTEN for its potential in a second commercial market, the multi-billion-dollar glaucoma market, with promising preliminary results; the glaucoma market will grow; the Company will have adequate financing through the end of the year and well into 2025; the Company will position itself for sustained growth and long-term success; and the NurExone platform technology being able to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.
Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to risks related to the Company’s early stage of development; lack of revenues to date; government regulation; market acceptance for its products; rapid technological change; dependence on key personnel; protection of the Company’s intellectual property; dependence on the Company’s strategic partners; the fact that preclinical drug development is uncertain, and the drug product candidates of the Company may never advance to clinical trials and/or on the timelines set out herein; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of the Company; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of the Company; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of the Company; the Company being unable to have sustained growth and/or continued success; risks that the Company’s intellectual property and technology won’t have the intended impact on the Company and/or its business; the Company’s inability to realize upon partnerships; risks that the Company will not have adequate financing through the end of the year and/or well into 2025; risks that the Company will be unable to position itself for sustained growth and long-term success; the receipt of the Orphan Medicinal Product Designation not having the intended benefits and incentives on the Company and its business as set out herein; the Company not entering the European market and bringing its products to patients across Europe; risk that the Company will not make significant strides on the path towards human trials with assistance from Dr. Yona Geffen; risk that the Company will not collaborate with the Goldschleger Eye Institute at Sheba Medical Center to study ExoPTEN for its potential in a second commercial market, the multi-billion-dollar glaucoma market, with promising preliminary results already available; risk that the NurExone platform technology will be unable to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications; and the risks discussed under the heading “Risk Factors” on pages 44 to 51 of the Company’s Annual Information Form dated August 27, 2024, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca. These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.
Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.
___________________________
(1) Global Glaucoma Treatment Market Analysis by Spherical Insights LLP
FAQ
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