Clene Announces Closing of $7.3 Million Registered Direct Offering and Concurrent Private Placements and Amendment of Debt Facility
Clene Inc. (Nasdaq: CLNN) has announced the closing of a $7.3 million registered direct offering and concurrent private placements of common stock and warrants. The offering was led by a healthcare-focused institutional investor with participation from existing shareholders, including insiders. Additionally, Clene amended its debt facility with Avenue Venture Opportunities Fund, L.P., reducing or deferring future monthly principal payments and extending the maturity date into the first half of 2025.
The combined financing is expected to fund the company's operations into the first quarter of 2025, enabling key milestones such as a face-to-face meeting with the FDA to discuss the potential filing of a new drug application for CNM-Au8® under an accelerated approval pathway. This funding also allows continued provision of CNM-Au8 to ALS patients under compassionate use programs while Clene discusses its data with the FDA.
Clene Inc. (Nasdaq: CLNN) ha annunciato la chiusura di un offerta diretta registrata di 7,3 milioni di dollari e di collocamenti privati concomitanti di azioni ordinarie e warrant. L'offerta è stata guidata da un investitore istituzionale focalizzato sulla salute, con la partecipazione di azionisti esistenti, compresi gli insider. Inoltre, Clene ha modificato la sua struttura debitoria con Avenue Venture Opportunities Fund, L.P., riducendo o posticipando i pagamenti mensili del capitale futuri e prorogando la data di scadenza nella prima metà del 2025.
Il finanziamento combinato è previsto per finanziare le operazioni dell'azienda fino al primo trimestre del 2025, consentendo il raggiungimento di traguardi chiave come un incontro faccia a faccia con la FDA per discutere la potenziale presentazione di una nuova domanda di farmaco per CNM-Au8® sotto un percorso di approvazione accelerato. Questo finanziamento consente anche la continuazione della fornitura di CNM-Au8 ai pazienti affetti da SLA nell'ambito dei programmi di uso compassionevole, mentre Clene discute i suoi dati con la FDA.
Clene Inc. (Nasdaq: CLNN) ha anunciado el cierre de una oferta directa registrada de 7.3 millones de dólares y colocaciones privadas concomitantes de acciones comunes y warrants. La oferta fue liderada por un inversor institucional enfocado en salud, con la participación de accionistas existentes, incluidos los internos. Además, Clene modificó su facilidad de deuda con Avenue Venture Opportunities Fund, L.P., reduciendo o aplazando futuros pagos mensuales de capital y extendiendo la fecha de vencimiento a la primera mitad de 2025.
El financiamiento combinado se espera que financie las operaciones de la empresa hasta el primer trimestre de 2025, permitiendo alcanzar hitos clave como una reunión presencial con la FDA para discutir la posible presentación de una nueva solicitud de medicamento para CNM-Au8® bajo una vía de aprobación acelerada. Este financiamiento también permite la provisión continua de CNM-Au8 a pacientes con ELA bajo programas de uso compasivo mientras Clene discute sus datos con la FDA.
클레네 주식회사 (Nasdaq: CLNN)는 730만 달러 규모의 등록 직접 공모와 일반 주식 및 워런트의 동시 개인 배급 마감을 발표했습니다. 이 공모는 건강 관리에 중점을 둔 기관 투자자가 주도했으며 기존 주주들도 참여했습니다. 또한, 클레네는 Avenue Venture Opportunities Fund, L.P.와의 채무 시설 계약을 수정하여 향후 월별 원금 지급을 줄이거나 유예하고 만기일을 2025년 상반기로 연장했습니다.
결합된 금융 지원은 회사의 운영을 2025년 1분기까지 지원할 것으로 기대됩니다, 이는 CNM-Au8®에 대한 새로운 약물 신청 가능성을 논의하기 위해 FDA와 직접 대면하는 중요한 이정표 달성을 가능하게 합니다. 이 자금 지원은 클레네가 FDA와 데이터를 논의하는 동안 ALS 환자들에게 CNM-Au8을 연민적 사용 프로그램을 통해 지속적으로 제공할 수 있도록 지원합니다.
Clene Inc. (Nasdaq: CLNN) a annoncé la clôture d'une offre directe enregistrée de 7,3 millions de dollars et de placements privés concomitants d'actions ordinaires et de bons de souscription. L'offre a été dirigée par un investisseur institutionnel axé sur la santé et a vu la participation d'actionnaires existants, y compris des initiés. De plus, Clene a modifié sa facilité de crédit avec le Avenue Venture Opportunities Fund, L.P., réduisant ou reportant les paiements mensuels du capital à venir et prolongeant la date d'échéance jusqu'au premier semestre 2025.
Le financement combiné devrait financer les opérations de l'entreprise jusqu'au premier trimestre 2025, permettant d'atteindre des jalons clés tels qu'une réunion en personne avec la FDA pour discuter de la possibilité de soumettre une nouvelle demande de médicament pour CNM-Au8® dans le cadre d'une voie d'approbation accélérée. Ce financement permet également la poursuite de la fourniture de CNM-Au8 aux patients atteints de la SLA dans le cadre de programmes d'utilisation compassionnelle, pendant que Clene discute de ses données avec la FDA.
Clene Inc. (Nasdaq: CLNN) hat den Abschluss eines registrierten Direktangebots über 7,3 Millionen Dollar sowie von parallelen Privatplatzierungen von Stammaktien und Warrants bekannt gegeben. Das Angebot wurde von einem auf Gesundheitswesen fokussierten institutionellen Investor geleitet, an dem auch bestehende Aktionäre, einschließlich Insider, teilnahmen. Darüber hinaus hat Clene sein Schuldenangebot mit Avenue Venture Opportunities Fund, L.P. geändert, um zukünftige monatliche Kapitalzahlungen zu reduzieren oder aufzuheben und das Fälligkeitsdatum auf die erste Hälfte von 2025 zu verlängern.
Die kombinierte Finanzierung wird voraussichtlich die Geschäftstätigkeit des Unternehmens bis zum ersten Quartal 2025 finanzieren, was wichtige Meilensteine ermöglicht, wie ein persönliches Treffen mit der FDA, um die mögliche Einreichung eines neuen Arzneimittelantrags für CNM-Au8® im Rahmen eines beschleunigten Genehmigungsverfahrens zu erörtern. Diese Finanzierung ermöglicht auch die fortgesetzte Bereitstellung von CNM-Au8 für ALS-Patienten im Rahmen von Programmen für mitfühlende Anwendungen, während Clene seine Daten mit der FDA erörtert.
- Secured $7.3 million in funding through registered direct offering and private placements
- Amended debt facility with Avenue Venture Opportunities Fund, reducing or deferring principal payments
- Extended funding runway into Q1 2025, supporting key milestones
- Potential for additional capital through future warrant exercises
- Support from both new healthcare-focused institutional investor and existing shareholders
- Dilution of existing shareholders due to new stock issuance
- Continued reliance on external financing to fund operations
Insights
This financing round is a significant development for Clene, providing important capital to extend its operational runway. The
The participation of both new institutional investors and existing shareholders, including company insiders, signals confidence in Clene's prospects. The debt facility amendment with Avenue Venture Opportunities Fund, reducing or deferring future monthly principal payments and extending the maturity date, provides additional financial flexibility.
For investors, this financing addresses near-term cash concerns and aligns the company's runway with key potential catalysts. However, the dilutive effect of the offering and the addition of warrants should be considered. The market pricing of the offering suggests neutral market sentiment, while the insider participation could be viewed positively. Overall, this financing strengthens Clene's position as it approaches critical regulatory discussions for its lead candidate in ALS and MS treatment.
Clene's financing strategy is closely tied to the development of CNM-Au8, its catalytically active gold nanocrystal suspension for neurological diseases. The extended runway into Q1 2025 is important as it covers the planned FDA meeting to discuss a potential accelerated approval pathway for CNM-Au8. This is a significant milestone that could dramatically shorten the time to market for their lead candidate.
The company's focus on amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS) targets areas of high unmet medical need. The continued support for compassionate use programs during regulatory discussions is noteworthy, as it maintains patient access and could provide additional real-world data to support the drug's efficacy and safety profile.
For investors, the key inflection point to watch is the outcome of the FDA meeting. A positive response regarding the accelerated approval pathway could significantly de-risk the development program and potentially lead to earlier commercialization. However, it's important to note that regulatory discussions are inherently uncertain and the FDA's stance on the accelerated approval pathway for CNM-Au8 will be critical in determining the company's near-term trajectory and potential future financing needs.
- Investment led by healthcare-focused institutional investor with participation from SymBiosis; founding investor Kensington Capital Holdings; Clene’s Chairman of the Board of Directors, Chief Executive Officer and Chief Scientific Officer and Founder; along with support from several other previously existing shareholders
$7.3 million registered direct offering and concurrent private placements priced at market under Nasdaq rules- Amended debt facility with Avenue Venture Opportunities Fund, L.P. in conjunction with financing
- Aggregate financing, including amendment to debt facility, expected to be sufficient to fund Company into the first quarter of 2025, including a face-to-face meeting with the FDA to discuss the potential to file a new drug application under the accelerated approval pathway for CNM-Au8®, a catalytically active gold nanocrystal suspension
SALT LAKE CITY, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly-owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurological diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced the closing of a registered direct offering and concurrent private placements (collectively, the “offering”) of common stock and warrants with a healthcare-focused institutional investor and existing shareholders, including insiders, with total gross proceeds of
Additionally, Clene announced the amendment of its existing debt facility with Avenue Venture Opportunities Fund, L.P. (“Avenue”) in which the parties agreed to reduce or defer future monthly principal payments and extend the principal amortization period and maturity date into the first half of 2025.
The offering was led by a healthcare-focused institutional investor with participation from SymBiosis; founding investor Kensington Capital Holdings; Clene’s Chairman of the Board of Directors, Chief Executive Officer and Chief Scientific Officer and Founder; along with support from several other previously existing shareholders.
The offering, combined with the amendment to the debt facility with Avenue, is expected to enable the Company to fund its operations into the first quarter of 2025. This funding enables runway for key inflection points, including the face-to-face meeting with the United Stated Food and Drug Administration (“FDA”) to discuss the potential to file a new drug application (“NDA”) for CNM-Au8 under an accelerated approval pathway.
David Matlin, Clene’s Chairman of the Board, added, “We are appreciative for the support of both our new healthcare-focused institutional investor as well as existing shareholders, including insiders. The capital raised in this offering along with the debt principal deferral from Avenue will allow the company to fund itself while in discussions with the FDA to potentially file an NDA under the accelerated approval pathway by year end. Most importantly, this financing also enables people with ALS who currently take CMN-Au8 under our compassionate use programs to continue receiving drug while Clene discusses its data with the FDA.”
About Clene
Clene Inc., (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis. CNM-Au8® is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on X (formerly Twitter) and LinkedIn.
Forward Looking Statements:
This press release contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the “safe harbor” provisions created by those laws. Clene’s forward-looking statements include, but are not limited to, statements regarding the Company’s expectations, hopes, beliefs, intentions or strategies. In addition, any statements that refer to characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties and the Company’s expectations, hopes, beliefs, intentions or strategies, the Company’s actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include the Company’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; the Company’s ability to achieve commercial success for its drug candidates, if approved; the Company’s limited operating history and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, and other risks and uncertainties set forth in “Risk Factors” in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.
Media Contact
Ignacio Guerrero-Ros, Ph.D., or
David Schull
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310
Investor Contact
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
(617) 283-2856
FAQ
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