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WALTHAM, Mass., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the quarter ended June 30, 2025, and provided recent business highlights.
“We believe we are entering a remarkable period of change for the company that points toward an exciting future,” said Marc Elia, Chairman of the Board at Invivyd. “Having characterized VYD2311 safety and pharmacokinetics in our Phase 1/2 trial, we are fully engaged on designing our clinical and go-to-market strategy for what we believe will be an exciting alternative to COVID-19 vaccination. As PEMGARDA® (pemivibart) moves into the fall season, we expect to move quickly to cement our position as the leading provider of monoclonal antibody technology for Americans in need of COVID-19 protection. With U.S. Food and Drug Administration (FDA) advice in hand, we look forward to the VYD2311 Phase 2/3 clinical trial design and finalization with the FDA, including anticipated alignment on a pivotal study plan for pediatrics, and advancement of other pipeline opportunities that leverage our technology, such as RSV and measles.”
“While the second quarter PEMGARDA growth was modest, the base business is growing along with our internal commercial capabilities, while we are simultaneously looking toward an improved target product profile with VYD2311 to protect ordinary Americans from symptomatic COVID-19,” said Bill Duke, Chief Financial Officer of Invivyd. “In addition to further protocol development to advance VYD2311, we look forward to additional upcoming anticipated milestones including identification of a potentially best-in-class RSV candidate in Q3 2025, identification of a preclinical measles candidate by the end of 2025, and advancement of our efforts to support the Long COVID community with the recently formed SPEAR Study Group.”
Recent Business Highlights
Second Quarter 2025 Financial Results:
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, treatment of Long COVID, 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 90%, based on available information including variant susceptibility to PEMGARDA and national variant frequencies.
About CANOPY
The CANOPY Phase 3 clinical trial was designed to evaluate the safety and tolerability of pemivibart and to assess immunobridging from pemivibart to certain historical data from the company’s previous Phase 2/3 clinical trial of adintrevimab (ADG20) for the prevention of symptomatic COVID-19 (EVADE). Additionally, there were pre-specified exploratory endpoints through three, six and twelve months to evaluate clinical efficacy of pemivibart compared to placebo in the prevention of RT-PCR-confirmed symptomatic COVID-19. The latest analysis from the Phase 3 CANOPY clinical trial included 365-day data. The CANOPY clinical trial enrolled participants in two cohorts: Cohort A was a single-arm, open-label trial in adults with moderate-to-severe immune compromise including complex underlying medical conditions. Cohort B was a randomized, placebo-controlled cohort that enrolled adults without moderate-to-severe immune compromise at risk of acquiring COVID-19 due to regular unmasked face-to-face interactions in indoor settings.
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 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.
Trademarks are the property of their respective owners.
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, the company’s target of achieving profitability; expectations regarding the COVID-19 landscape and upcoming respiratory virus season; beliefs about the company’s market position; plans related to the company’s research and development activities; expectations regarding the biophysical properties, clinical trial design, regulatory pathway, target product profile and target populations for VYD2311; the anticipated focus and goals of the SPEAR Study Group; the ongoing in vitro neutralizing activity of PEMGARDA against dominant SARS-CoV-2 variants; the potential of PEMGARDA as a mAb for pre-exposure prophylaxis (prevention) of COVID-19 in certain immunocompromised persons; the potential of VYD2311 as a novel mAb candidate that may be able to deliver clinically meaningful titer levels through more patient-friendly means; the company’s devotion to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; potential pipeline expansion beyond SARS-CoV-2, including potential targets such as RSV and measles, and expected announcements related thereto; 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: uncertainties regarding the company’s expectations, projections and estimates regarding future costs and expenses, future revenue, capital requirements, and the availability of and the need for additional financing; whether the company’s cash and cash equivalents are sufficient to support its operating plan for as long as anticipated; uncertainties regarding market acceptance, payor coverage and reimbursement, or future revenue generated by PEMGARDA; how long the EUA granted by the FDA for PEMGARDA will remain in effect and whether such EUA is revised or revoked by the FDA; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of any product candidate following regulatory authorization or approval; the success of the company’s in-house sales force, and company’s ability to maintain and expand sales, marketing and distribution capabilities to successfully commercialize PEMGARDA; changes in expected or existing competition; changes in the regulatory environment; the outcome of the company’s engagement with regulators; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways; uncertainties related to reaching agreement with FDA on the safety database size for the pivotal clinical trial of VYD2311 and full protocol review; clinical trial site activation or enrollment rates; the timing, progress and results of the company’s discovery, preclinical and clinical development activities; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of the company’s product candidates based on neutralizing activity in nonclinical studies; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; whether the epitope that pemivibart and VYD2311 targets remains structurally intact; whether the company’s product candidates are able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; whether the company’s integrated technology platform is able to produce mAbs with broad and durable viral protection along with improved drug properties; the company’s reliance on third parties; complexities of manufacturing mAb therapies, and availability of quantities of commercial product in the future, if authorized or approved; macroeconomic and political uncertainties; the company’s ability to realize the anticipated benefits of its term loan facility; 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 and the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, each 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.
This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.
Contacts:
Media Relations
(781) 208-1747
[email protected]
Investor Relations
(781) 208-1747
[email protected]
| INVIVYD, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (In thousands, except share and per share amounts) | |||||||
| June 30, 2025 | December 31, 2024 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 34,905 | $ | 69,349 | |||
| Accounts receivable, net | 8,698 | 10,906 | |||||
| Prepaid expenses and other current assets | 15,678 | 20,426 | |||||
| Total current assets | 59,281 | 100,681 | |||||
| Inventory | 25,440 | 25,907 | |||||
| Property and equipment, net | 1,392 | 1,508 | |||||
| Operating lease right-of-use assets | 3,010 | 1,385 | |||||
| Other non-current assets | 15 | 34 | |||||
| Total assets | $ | 89,138 | $ | 129,515 | |||
| Liabilities, Preferred Stock and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 18,051 | $ | 10,448 | |||
| Accrued expenses(1) | 25,307 | 50,197 | |||||
| Operating lease liabilities | 1,067 | 1,304 | |||||
| Other current liability | 26 | 27 | |||||
| Total current liabilities | 44,451 | 61,976 | |||||
| Operating lease liabilities, non-current | 1,898 | — | |||||
| Total liabilities | 46,349 | 61,976 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Preferred stock (undesignated), $0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding at June 30, 2025 and December 31, 2024 | — | — | |||||
| Common stock, $0.0001 par value; 1,000,000,000 shares authorized, 120,142,811 shares issued and outstanding at June 30, 2025; 119,835,162 shares issued and outstanding at December 31, 2024 | 12 | 12 | |||||
| Additional paid-in capital | 975,759 | 969,526 | |||||
| Accumulated other comprehensive loss | (39 | ) | (5 | ) | |||
| Accumulated deficit | (932,943 | ) | (901,994 | ) | |||
| Total stockholders’ equity | 42,789 | 67,539 | |||||
| Total liabilities, preferred stock and stockholders’ equity | $ | 89,138 | $ | 129,515 | |||
(1) Includes related-party amounts of $490 and $1,274 as of June 30, 2025 and December 31, 2024, respectively.
| INVIVYD, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) (In thousands, except share and per share amounts) | ||||||||||||||||
| Three Months Ended June 30, | Three Months Ended June 30, | Six Months Ended June 30, | Six Months Ended June 30, | |||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue, net | $ | 11,786 | $ | 2,264 | $ | 23,090 | $ | 2,264 | ||||||||
| Total revenue | 11,786 | 2,264 | 23,090 | 2,264 | ||||||||||||
| Operating costs and expenses: | ||||||||||||||||
| Cost of product revenue(1) | 685 | 88 | 1,519 | 88 | ||||||||||||
| Research and development(2) | 9,573 | 30,334 | 20,214 | 61,494 | ||||||||||||
| Selling, general and administrative | 16,588 | 21,089 | 33,339 | 36,018 | ||||||||||||
| Total operating costs and expenses | 26,846 | 51,511 | 55,072 | 97,600 | ||||||||||||
| Loss from operations | (15,060 | ) | (49,247 | ) | (31,982 | ) | (95,336 | ) | ||||||||
| Other income: | ||||||||||||||||
| Other income, net | 400 | 2,000 | 1,033 | 4,593 | ||||||||||||
| Total other income, net | 400 | 2,000 | 1,033 | 4,593 | ||||||||||||
| Net loss | (14,660 | ) | (47,247 | ) | (30,949 | ) | (90,743 | ) | ||||||||
| Other comprehensive income (loss) | ||||||||||||||||
| Unrealized (loss) gain, net of tax | (26 | ) | — | (34 | ) | 1 | ||||||||||
| Comprehensive loss | $ | (14,686 | ) | $ | (47,247 | ) | $ | (30,983 | ) | $ | (90,742 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.12 | ) | $ | (0.40 | ) | $ | (0.26 | ) | $ | (0.77 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 120,016,132 | 119,362,670 | 119,950,172 | 117,490,439 | ||||||||||||
(1) Includes related-party amounts of $472 and $924 for the three and six months ended June 30, 2025 and no related-party amounts for the three and six months ended June 30, 2024.
(2) Includes related-party amounts of $1,140 and $2,268 for the three and six months ended June 30, 2025 and $1,131 and $2,266 for the three and six months ended June 30, 2024, respectively.
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