Invivyd, Inc. 10-Q

Item 1A . Risk Factors. Information regarding risks and uncertainties related to our business appears in Part I, Item 1A. “Risk Factors” of the 2025 Form 10-K. As of the date of this Quarterly Report on Form 10-Q, there have been no material changes from the risk factors set forth in the 2025 Form 10-K, other than as described below. The HHS declaration under Section 564 of the FDCA authorizing emergency use of COVID-19 drugs and biologics will be terminated, effective June 29, 2027, and, consequently, the EUA for PEMGARDA is set to terminate on such date. When the EUA for PEMGARDA is terminated, we will be unable to sell PEMGARDA unless we are successful in obtaining regulatory approval, the process for which may be lengthy, time consuming and inherently unpredictable. If we are not able to timely obtain regulatory approval for PEMGARDA before the EUA for PEMGARDA terminates, we will not be able to continue to generate product revenue from PEMGARDA and our business will be substantially harmed. PEMGARDA is our first and only product candidate that has received regulatory authorization. PEMGARDA is not approved, but has been authorized for emergency use in the United States by the FDA under an EUA for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients. 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 FDCA, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is revoked sooner. On June 30, 2026, HHS provided advance notice of the termination of the declaration, which will take effect after a twelve-month transition period ending on June 29, 2027. Consequently, the EUA for PEMGARDA is set to terminate on June 29, 2027. We may not market any drug product candidates in the United States unless we have regulatory authorization with an EUA or approval of a BLA from the FDA. Other than the EUA for PEMGARDA in the United States, we have not obtained regulatory authorization or approval for any other product candidate in any other jurisdiction. When the EUA for PEMGARDA is terminated, we will be unable to sell PEMGARDA unless we are successful in obtaining regulatory approval, the process for which may be lengthy, time consuming and inherently unpredictable. The time required to obtain approval depends upon numerous factors, including substantial discretion of the FDA. The FDA may change its policies, issue additional regulations, revise existing regulations or take other actions that could impose requirements upon us that prevent or delay us from successfully pursuing or receiving regulatory approval on a timely basis. Our potential to obtain a BLA for PEMGARDA before the EUA for PEMGARDA terminates will require aligning with the FDA on the data required to support such regulatory approval, including whether the existing body of evidence supporting the emergency use of PEMGARDA is sufficient to satisfy BLA approval standards or whether additional data would be required to support approval. The HHS Secretary is obligated under Section 564(b)(5) of the FDCA to provide sponsors written notice of potential obstacles for an EUA product’s approval, including specific actions to be taken by HHS and the sponsor to overcome the same, when a product’s EUA has been in effect for more than one year. However, neither HHS nor the FDA has provided us with such written advice regarding a regulatory approval pathway for PEMGARDA to date, and there is no guarantee of the outcome of our regulatory engagement with the FDA or the timing thereof. Other risks and uncertainties associated with the future PEMGARDA EUA termination and the twelve-month transition period before the PEMGARDA EUA is set to terminate include: • the potential adverse impact on PEMGARDA demand, including the willingness of physicians to continue to prescribe PEMGARDA and their patients’ willingness to continue to receive PEMGARDA while it remains authorized; • uncertainties regarding third-party payor coverage and reimbursement dynamics; • uncertainties regarding continued PEMGARDA placement in COVID-19 prevention guidelines; • the potential for the future PEMGARDA EUA termination to render certain PEMGARDA inventory obsolete, which may require a write down or write off, which could adversely affect our operating results; 42 • any potential adverse publicity or unfavorable public perceptions related to the termination of the HHS declaration under Section 564 of the FDCA authorizing emergency use of COVID-19 drugs and biologics; • our ability to comply with the covenants or other terms of our Loan Agreement, including our ability to achieve the net product revenue milestones required to enable us to draw down on the term loan facility; and • the potential adverse impact on our stock price and our ability to access capital when needed on acceptable terms. Additionally, in connection with the termination of the declaration under Section 564 of the FDCA authorizing emergency use of COVID-19 drugs and biologics, the FDA intends to decline to review and process any new EUA requests for COVID-19 drugs or biologics. Therefore, although we received an EUA from the FDA for PEMGARDA, we would be precluded from pursuing an EUA from the FDA for VYD2311 or other COVID-19 product candidates and, instead, we would need to pursue traditional regulatory approval processes, which may be lengthy and expensive. Since our inception, we have financed our operations primarily with net proceeds from several public and private offerings of our capital stock. After receiving an EUA from the FDA for PEMGARDA in March 2024, we have also funded our operations from sales of PEMGARDA, but we have no other product candidates authorized or approved for commercialization. We will remain dependent on the commercial success of PEMGARDA, while it remains authorized, until VYD2311, our next-generation mAb candidate for COVID-19, or any other product candidate completes clinical development, receives regulatory approval and is successfully commercialized, if ever. If we are not able to timely obtain regulatory approval for PEMGARDA before the EUA for PEMGARDA terminates, we will not be able to generate product revenue from PEMGARDA and our business will be substantially harmed. We may not be able to regain or maintain compliance with the continued listing standards of Nasdaq. Our common stock is listed on the Nasdaq Global Market, and we are therefore subject to its continued listing requirements, including requirements with respect to the market value of publicly-held shares, market value of listed shares, minimum bid price per share, and minimum stockholders’ equity, among others, and requirements relating to board and committee independence. If we fail to satisfy one or more of the requirements and are unable to timely regain compliance, we may be delisted from the Nasdaq Global Market. For example, on July 23, 2026, we received a letter from Nasdaq notifying us that, because the closing bid price for our common stock had closed below $1.00 per share for 30 consecutive business days, we no longer complied with the minimum bid price requirement for continued listing on the Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Requirement”). Nasdaq’s notice has no immediate effect on the listing of our common stock, and, in accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have until January 19, 2027 to regain compliance with the Minimum Bid Price Requirement by maintaining a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days, unless Nasdaq exercises its discretion to extend this ten-day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). In the event that we do not regain compliance by January 19, 2027, we may be eligible for additional time to regain compliance with the Minimum Bid Price Requirement. We previously received similar letters from Nasdaq on December 27, 2024 and April 21, 2025, and, in each case, we were subsequently notified by Nasdaq that we had regained compliance with the Minimum Bid Price Requirement, and the matter with respect to each period of non-compliance was closed. To the extent that we are unable to regain compliance with the Minimum Bid Price Requirement or fail to maintain compliance with Nasdaq’s other continued listing requirements, there is a risk that our common stock may be delisted from Nasdaq. Delisting from Nasdaq may adversely affect our ability to raise additional financing through the public or private sale of equity securities, significantly affect the ability of investors to trade our securities, or negatively affect the value and liquidity of our common stock. Delisting also could have other negative results, including the potential loss of employee confidence, the loss of institutional investors or interest in potential business development opportunities. Furthermore, if we are delisted from Nasdaq and we are not able to list our common stock on another exchange, our common stock may be eligible to trade on an over-the-counter system, such as the OTCQB market, where an investor may find it more difficult to sell our common stock or obtain accurate quotations as to the market value of our common stock. We cannot assure you that our common stock, if delisted from Nasdaq, will be listed on another national securities exchange or quoted on an over-the-counter quotation system. Item 2 . Unregistered Sales of Equity Securities and Use of Proceeds. Recent Sales of Unregistered Securities; Use of Proceeds We did not issue any unregistered equity securities during the three months ended June 30, 2026. 43 Purchases of Equity Securities by the Issuer We did not purchase any of our equity securities during the three months ended June 30, 2026.