Full Press Release Details
Invivyd Reports First Quarter 2025 Financial Results and Recent Business Highlights
WALTHAM, Mass., May 15, 2025 Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the quarter ended
March 31, 2025, and provided recent business highlights.
To drive long-term topline growth, we made a strategic decision to internalize our
sales force at the beginning of 2025, said Bill Duke, Chief Financial Officer of Invivyd. Although this shift created a short-term headwind, we re now seeing positive momentum with a return to growth and early signs of acceleration
in Q2 2025. Backed by a strong cash position and potential to access up to $30 million in non-dilutive funding through our term loan facility, we remain focused on disciplined financial execution and
continue to target profitability by the end of the first half of 2025.
Recent Business Highlights
Recent Pipeline Highlights
First Quarter 2025 Financial Results:
Conference Call & Webcast
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 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 90%, based on available information including variant susceptibility to PEMGARDA and national variant frequencies.
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.
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
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.
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, the company s goal of
near-term profitability; the company s expectations regarding anticipated growth of net product revenue and continued reduction of operating expenses; expectations related to the company s term loan facility; the company s
ongoing research and development activities, as well as future potential research and development efforts; 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 adults and adolescents who have moderate-to-severe immune compromise; the potential of VYD2311 as a novel mAb
candidate that may be able to deliver clinically meaningful titer levels through more patient-friendly means, and potentially available regulatory pathways; 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 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 the 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; 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; clinical trial site activation or enrollment rates; the complexities of
manufacturing mAb therapies; 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, 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.
CONDENSED CONSOLIDATED BALANCE SHEETS
thousands, except share and per share amounts)
| March 31, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 48,078 | $ | 69,349 | ||||
| Accounts receivable | 8,561 | 10,906 | ||||||
| Prepaid expenses and other current assets | 19,186 | 20,426 | ||||||
| Total current assets | 75,825 | 100,681 | ||||||
| Inventory | 25,419 | 25,907 | ||||||
| Property and equipment, net | 1,523 | 1,508 | ||||||
| Operating lease right-of-use assets | 953 | 1,385 | ||||||
| Other non-current assets | 24 | 34 | ||||||
| Total assets | $ | 103,744 | $ | 129,515 | ||||
| Liabilities, Preferred Stock and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 8,739 | $ | 10,448 | ||||
| Accrued expenses (1) | 39,928 | 50,197 | ||||||
| Operating lease liabilities | 894 | 1,304 | ||||||
| Other current liability | 34 | 27 | ||||||
| Total current liabilities | 49,595 | 61,976 | ||||||
| Total liabilities | 49,595 | 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 March 31, 2025 and December 31, 2024 | ||||||||
| Common stock, $0.0001 par value; 1,000,000,000 shares authorized, 119,961,445 shares issued and outstanding at March 31, 2025; 119,835,162 shares issued and outstanding at December 31, 2024 | 12 | 12 | ||||||
| Additional paid-in capital | 972,433 | 969,526 | ||||||
| Accumulated other comprehensive loss | (13 | ) | (5 | ) | ||||
| Accumulated deficit | (918,283 | ) | (901,994 | ) | ||||
| Total stockholders equity | 54,149 | 67,539 | ||||||
| Total liabilities, preferred stock and stockholders equity | $ | 103,744 | $ | 129,515 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
thousands, except share and per share amounts)
| Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | |||||||
| Revenue: | ||||||||
| Product revenue, net | $ | 11,304 | $ | |||||
| Total revenue | 11,304 | |||||||
| Operating costs and expenses: | ||||||||
| Cost of product revenue (1) | 834 | |||||||
| Research and development (2) | 10,641 | 31,160 | ||||||
| Selling, general and administrative | 16,751 | 14,929 | ||||||
| Total operating costs and expenses | 28,226 | 46,089 | ||||||
| Loss from operations | (16,922 | ) | (46,089 | ) | ||||
| Other Income: | ||||||||
| Other Income, net | 633 | 2,593 | ||||||
| Total other income, net | 633 | 2,593 | ||||||
| Net Loss | (16,289 | ) | (43,496 | ) | ||||
| Other comprehensive income (loss) | ||||||||
| Unrealized (loss) gain, net of tax | (8 | ) | 1 | |||||
| Comprehensive loss | $ | (16,297 | ) | (43,495 | ) | |||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.14 | ) | $ | (0.38 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 119,883,479 | $ | 115,618,209 |