Invivyd Announces $30M Non-dilutive Loan Facility with Silicon Valley Bank
Invivyd (Nasdaq: IVVD) has secured a $30 million term loan facility with Silicon Valley Bank (SVB), a division of First Citizens Bank. The non-dilutive financing agreement allows for future capital drawdown subject to meeting specific conditions and milestones.
The company's CFO Bill Duke highlighted that this facility was secured ahead of important anticipated catalysts, including alignment with the FDA on the regulatory pathway for their pipeline candidate VYD2311. The non-dilutive nature of the financing is aimed at maintaining balance sheet flexibility while focusing on per-share value creation.
Invivyd (Nasdaq: IVVD) ha ottenuto una linea di credito a termine da 30 milioni di dollari con Silicon Valley Bank (SVB), una divisione di First Citizens Bank. L'accordo di finanziamento non diluitivo consente prelievi futuri di capitale, subordinati al raggiungimento di specifiche condizioni e traguardi.
Il CFO dell'azienda, Bill Duke, ha sottolineato che questa linea di credito è stata assicurata in vista di importanti catalizzatori attesi, incluso l'allineamento con la FDA sul percorso regolatorio del loro candidato di pipeline VYD2311. La natura non diluitiva del finanziamento mira a mantenere la flessibilità del bilancio, concentrandosi sulla creazione di valore per azione.
Invivyd (Nasdaq: IVVD) ha asegurado una línea de préstamo a plazo de 30 millones de dólares con Silicon Valley Bank (SVB), una división de First Citizens Bank. El acuerdo de financiamiento no dilutivo permite futuros desembolsos de capital, sujetos al cumplimiento de condiciones y hitos específicos.
El CFO de la compañía, Bill Duke, destacó que esta línea fue asegurada antes de importantes catalizadores anticipados, incluyendo la alineación con la FDA sobre la vía regulatoria para su candidato de pipeline VYD2311. La naturaleza no dilutiva del financiamiento busca mantener la flexibilidad del balance mientras se enfoca en la creación de valor por acción.
Invivyd (나스닥: IVVD)는 First Citizens Bank의 자회사인 Silicon Valley Bank(SVB)와 함께 3천만 달러 규모의 기한부 대출 시설을 확보했습니다. 이 비희석성 금융 계약은 특정 조건과 이정표를 충족하는 경우 향후 자본 인출이 가능합니다.
회사의 CFO 빌 듀크는 이 시설이 파이프라인 후보인 VYD2311에 대한 FDA와의 규제 경로 조율 등 중요한 예상 촉매 전에 확보되었다고 강조했습니다. 비희석성 금융의 목적은 대차대조표 유연성을 유지하면서 주당 가치 창출에 집중하는 것입니다.
Invivyd (Nasdaq : IVVD) a obtenu une ligne de crédit à terme de 30 millions de dollars auprès de Silicon Valley Bank (SVB), une division de First Citizens Bank. Cet accord de financement non dilutif permet des tirages de capital futurs sous réserve de la réalisation de conditions et jalons spécifiques.
Le directeur financier de la société, Bill Duke, a souligné que cette facilité avait été obtenue avant des catalyseurs importants attendus, notamment l'alignement avec la FDA sur la voie réglementaire pour leur candidat pipeline VYD2311. Le caractère non dilutif du financement vise à préserver la flexibilité du bilan tout en se concentrant sur la création de valeur par action.
Invivyd (Nasdaq: IVVD) hat eine 30-Millionen-Dollar-Terminkreditfazilität mit der Silicon Valley Bank (SVB), einer Tochtergesellschaft der First Citizens Bank, gesichert. Die nicht verwässernde Finanzierungsvereinbarung erlaubt zukünftige Kapitalabrufe, vorbehaltlich der Erfüllung bestimmter Bedingungen und Meilensteine.
Der CFO des Unternehmens, Bill Duke, betonte, dass diese Fazilität vor wichtigen erwarteten Katalysatoren gesichert wurde, einschließlich der Abstimmung mit der FDA bezüglich des regulatorischen Wegs für ihren Pipeline-Kandidaten VYD2311. Die nicht verwässernde Natur der Finanzierung zielt darauf ab, die Bilanzflexibilität zu erhalten und gleichzeitig den Fokus auf die Wertschöpfung pro Aktie zu legen.
- Secured $30M non-dilutive loan facility providing additional capital without shareholder dilution
- Flexible drawdown terms based on milestone achievements
- Strengthens balance sheet ahead of FDA regulatory discussions
- Loan facility adds debt to company's balance sheet
- Capital access contingent on meeting undisclosed conditions and milestones
WALTHAM, Mass., April 21, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it has signed a
“We are pleased to have secured this term loan facility ahead of important anticipated catalysts, including gaining alignment with the FDA on the regulatory pathway of our pipeline candidate, VYD2311,” said Bill Duke, Chief Financial Officer of Invivyd. “The non-dilutive nature of this financing facility supports balance sheet optionality so the company can focus on per-share value creation.”
About VYD2311
VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration.
VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd’s investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19.
About PEMGARDA
PEMGARDA™ (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1, XEC and LP.8.1. PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby inhibiting virus attachment to the human ACE2 receptor on host cells.
PEMGARDA (pemivibart) injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
PEMGARDA is not authorized for use for treatment of COVID-19 or post-exposure prophylaxis of COVID-19. Pre-exposure prophylaxis with PEMGARDA is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate-to-severe immune compromise who may derive benefit from COVID-19 vaccinations, should receive COVID-19 vaccination. In individuals who have recently received a COVID-19 vaccine, PEMGARDA should be administered at least 2 weeks after vaccination.
Anaphylaxis has been observed with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis. The most common adverse reactions included systemic infusion-related reactions and hypersensitivity reactions, local infusion site reactions, and infusion site infiltration or extravasation. For additional information, please see the PEMGARDA full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning.
To support the EUA for PEMGARDA, an immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA. There are limitations of the data supporting the benefits of PEMGARDA. Evidence of clinical efficacy for other neutralizing human mAbs against SARS-CoV-2 was based on different populations and SARS-CoV-2 variants that are no longer circulating. Further, the variability associated with cell-based EC50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges. Additionally, certain SARS-CoV-2 viral variants may emerge that have substantially reduced susceptibility to PEMGARDA, and PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants.
The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner. PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to
About Invivyd
Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit https://invivyd.com/ to learn more.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “estimates,” “intends,” “potential,” “predicts,” “projects,” and “future” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, expectations related to the company’s term loan facility with SVB; the potential drawdown of capital in the future if certain conditions and milestones are met; the expected benefits of the financing facility; the company’s intention to focus on per-share value creation; anticipated catalysts of the company; the company’s expectation of gaining alignment with the FDA on the regulatory pathway for the company’s next product candidate; the company’s devotion to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company’s forward-looking statements and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the timing, progress and results of the company’s discovery, preclinical and clinical development activities; how long the EUA granted by the U.S. FDA for PEMGARDA will remain in effect and whether the EUA is revised or revoked by the U.S. FDA; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of any product candidate following regulatory authorization or approval; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways; changes in the regulatory environment; the outcome of the company’s engagement with regulators; the company’s ability to maintain and expand sales, marketing and distribution capabilities to successfully commercialize any authorized or approved product candidate; changes in expected or existing competition; the company’s reliance on third parties; the complexities of manufacturing mAb therapies; macroeconomic and political uncertainties; the company’s ability to realize the anticipated benefits of the company’s term loan facility with SVB; the company’s ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.
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Contacts:
Media Relations
(781) 208-1747
media@invivyd.com
Investor Relations
(781) 208-1747
investors@invivyd.com
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