Invivyd Reports First Quarter 2024 Financial Results and Recent Business Highlights Launched PEMGARDA in the U.S. for COVID-19 pre-exposure prophylaxis (PrEP) in certain adults and adolescents with moderate-to-severe imm

Invivyd Reports First Quarter 2024 Financial Results and Recent Business Highlights

WALTHAM, Mass., May 9, 2024 (GLOBE NEWSWIRE) Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from

serious viral infectious diseases, today announced financial results for the quarter ended March 31, 2024, and recent business highlights.

recent months have been incredibly productive for Invivyd. Moving into the commercial phase is a critical step for the company and we are executing on the PEMGARDA launch with maximum focus across the company, said Marc Elia, Chairman of the

Invivyd Board of Directors. In addition, we look forward to sharing on today s quarterly update call more of the scientific underpinnings of our plans going forward, including detail on the innovative engine we believe can deliver

meaningful product-level advancements with associated medical and economic value creation.

Recent Business Highlights

Recent Pipeline Highlights

First Quarter 2024 Financial Results:

Conference Call & Webcast

Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A

replay of the webcast will be available via the company s investor website approximately two hours after the call s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

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 a global Phase 2/3 clinical trial for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity in pseudotyped

virus-like particle and authentic virus neutralization assays against major SARS-CoV-2 variants, including JN.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. Anaphylaxis has been observed with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed

warning for anaphylaxis. The most common adverse events (all grades, incidence 2%) observed in participants who have moderate-to-severe immune compromise treated

with PEMGARDA included systemic and local infusion-related or hypersensitivity reactions, upper respiratory tract infection, viral infection, influenza-like illness, fatigue, headache, and nausea. 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. Additionally, 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.

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.

Invivyd, Inc. (Nasdaq: IVVD) is a

biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. The company s proprietary INVYMAB platform approach combines state-of-the-art viral surveillance and

predictive modeling with advanced antibody engineering. INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs) to address evolving viral threats. In March 2024, Invivyd received emergency use authorization

(EUA) from the U.S. FDA for its first mAb in a planned series 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, intends, potential, 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, PEMGARDA as a mAb for COVID-19

PrEP in certain adults and adolescents with moderate-to-severe immune compromise; the company s plans and expectations related to the commercialization of PEMGARDA;

the company s intention to pursue a rapid immunobridging pathway to potential EUA for COVID-19 treatment in certain immunocompromised people; the company s anticipated submission of a COVID-19 treatment EUA request to the FDA for pemivibart, and the timing thereof; the company s research and clinical development efforts, and the timing thereof; the potential of VYD222 for clinical protection

from symptomatic COVID-19 based on interim exploratory data from the CANOPY Phase 3 clinical trial; the company s expectation that PEMGARDA is the first mAb in a planned series of innovative antibody

candidates and VYD2311 will be the next mAb candidate to advance into clinical development; the future of the COVID-19 landscape; the company s belief that its innovative engine can deliver meaningful

product-level advancements with associated medical and economic value creation; the company s anticipated 2024 net product revenue and projected 2024 year-end cash position; the company s commitment

to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; the design of the company s INVYMAB platform approach to facilitate the

rapid, serial generation of new mAbs to address evolving viral threats; 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: how long the EUA granted by the FDA for PEMGARDA for COVID-19 PrEP in certain adults and adolescents with moderate-to-severe immune compromise will remain in effect and whether such EUA is revoked or revised by the FDA; the company s ability to maintain and expand sales,

marketing and distribution capabilities to successfully commercialize PEMGARDA; changes in expected or existing competition; the company s ability to effectively utilize an immunobridging pathway to potential EUA for pemivibart for COVID-19 treatment in certain immunocompromised people; whether the company is able to successfully submit a COVID-19 treatment EUA request to the FDA, and the timing, scope

and outcome of any such EUA request; uncertainties related to the regulatory authorization or approval process; changes in the regulatory environment; the timing and progress of the company s discovery, preclinical and clinical development

activities; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of PEMGARDA or any other product candidate following

regulatory authorization or approval; the predictability of clinical success of the company s product candidates based on neutralizing activity in preclinical studies; the risk that results of preclinical studies or clinical trials may not be

predictive of future results, and interim data are subject to further analysis; the company s reliance on third parties with respect to virus assay creation and product candidate testing and with respect to its clinical

trials; variability of results in models used to predict activity against SARS-CoV-2 variants; whether PEMGARDA or

any other product candidate is able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the

complexities of manufacturing mAb therapies; the company s dependence on third parties to manufacture, label, package, store and distribute clinical and commercial supplies of its product candidates; whether the company is able to provide

sufficient commercial supply of PEMGARDA to meet market demand; whether the company can obtain and maintain third-party coverage and adequate reimbursement for PEMGARDA or any other product candidate; the company s ability to deliver meaningful

product-level advancements with associated medical and economic value creation; the company s ability to leverage its INVYMAB platform approach to facilitate the rapid, serial generation of new mAbs to address evolving viral threats; any

litigation and other proceedings or government investigations relating to the company; the company s ability to continue as a going concern; the company s ability to optimize operating expenses; 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, 2023 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.

contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.

CONDENSED CONSOLIDATED BALANCE SHEETS

thousands, except share and per share amounts)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

thousands, except share and per share amounts)