WALTHAM, Mass., Aug. 14, 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 June 30, 2024, and recent business highlights.
Shortly after the PEMGARDA Emergency Use Authorization (EUA) was issued by the U.S. Food and Drug Administration (FDA) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised patients, Invivyd transitioned its commercial strategy to reflect the novel features of a newly commercial COVID-19 PrEP antibody marketplace. This commercial transition was designed to increase the company’s capabilities and accelerate awareness and education about PEMGARDA across multiple stakeholders in the field including healthcare professionals (HCPs), academic and major community medical institutions, and high-volume infusion centers. Under new commercial leadership, the company has onboarded multiple, highly experienced biopharmaceutical commercial leaders with an eye toward activating the marketplace in the coming respiratory virus season.
“Against the backdrop of rising, persistent COVID-19 disease, we are pleased with our progress in the quarter establishing a robust infrastructure to support PEMGARDA demand, access and utilization. We believe our early revenues reflect just the beginning of a unique, fast growing, medically critical prophylactic category in infectious disease. As we enter the peak fall/winter respiratory virus season, we aim to substantially increase PEMGARDA awareness and activation among HCPs, institutions, and vulnerable populations. Our expectation is that our ongoing commercial work can build a broad, high medical value category starting with PEMGARDA and continuing through novel pipeline molecules that may offer step changes in patient- and system-friendliness,” said Marc Elia, Chairperson of the Invivyd Board of Directors.
In addition, Invivyd expects to initiate in late August dosing a first-in-human clinical trial for VYD2311, a next generation anti-RBD monoclonal antibody (mAb) with substantially increased measured in vitro potency to date and other potentially favorable biophysical properties. While Invivyd has secured more than 100,000 total doses of PEMGARDA, expected potency and associated potential improvements to dose may result in substantially greater commercial quantities of VYD2311 should the molecule achieve regulatory authorization.
“Over two months at Invivyd, my appreciation for the company’s unique technology platform and ability for PEMGARDA to address the significant COVID-19 unmet need for certain immunocompromised people has grown tremendously,” said Tim Lee, Chief Commercial Officer of Invivyd. “We are excited about the positive commercial momentum we’ve seen, doubling available infusion sites from the end of May to the end of June, and again doubling from the end of June to the end of last week. We are enthusiastic about our efforts to drive awareness of PEMGARDA in the HCP community, expand reach to additional infusion centers, and add new programs to support patients. The fall will be here in weeks and the team is ready for action.”
Recent Business Highlights
Recent Pipeline Highlights
Second 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.
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 a global Phase 2/3 clinical trial for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity 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.
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.
About Invivyd
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 immunocompromised patients; the company’s plans, strategies, goals and expectations related to the commercialization of PEMGARDA; the company’s EUA amendment request to the FDA for PEMGARDA for the treatment of mild-to-moderate COVID-19 in certain immunocompromised patients; the company’s general alignment with the FDA on a immunobridging pathway to future potential EUAs for serial, novel mAbs for the prevention and treatment of symptomatic COVID-19, including the company’s beliefs regarding the potential benefits of utilizing such pathway; the company’s research and clinical development efforts, and the timing thereof, including with respect to a first-in-human clinical trial for VYD2311; the company’s expectation that PEMGARDA is the first mAb in a planned series of innovative antibody candidates; the company’s aim to build a broad, high medical value category starting with PEMGARDA and continuing through novel pipeline molecules; the future of the COVID-19 landscape, including the anticipated fall/winter respiratory virus season; 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 immunocompromised patients 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 outcome of the company’s EUA amendment request for PEMGARDA for treatment of mild-to-moderate COVID-19 in certain immunocompromised patients, and the timing thereof; 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 any product candidate following regulatory authorization or approval; 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; the company’s reliance on third parties with respect to virus assay creation and product candidate testing and with respect to its clinical trials; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; 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 can obtain and maintain third-party coverage and adequate reimbursement for PEMGARDA or any other product candidate; the company’s ability to build a broad, high medical value category starting with PEMGARDA and continuing through novel pipeline molecules; 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 legal proceedings or investigations relating to the company; 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, 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.
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| INVIVYD, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (In thousands, except share and per share amounts) | ||||||||
| June 30, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 147,881 | $ | 200,641 | ||||
| Accounts receivable, net | 2,888 | — | ||||||
| Inventory, net | 5,333 | — | ||||||
| Prepaid expenses and other current assets | 16,909 | 24,240 | ||||||
| Total current assets | 173,011 | 224,881 | ||||||
| Property and equipment, net | 1,772 | 1,896 | ||||||
| Operating lease right-of-use assets | 782 | 2,229 | ||||||
| Other non-current assets | 1,781 | 175 | ||||||
| Total assets | $ | 177,346 | $ | 229,181 | ||||
| Liabilities, Preferred Stock and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 7,499 | $ | 7,953 | ||||
| Accrued expenses | 26,822 | 40,860 | ||||||
| Deferred revenue | 1,681 | — | ||||||
| Operating lease liabilities, current | 681 | 1,443 | ||||||
| Other current liability | 21 | 35 | ||||||
| Total current liabilities | 36,704 | 50,291 | ||||||
| Operating lease liabilities, non-current | — | 722 | ||||||
| Other non-current liability | — | 700 | ||||||
| Total liabilities | 36,704 | 51,713 | ||||||
| Commitments and contingencies (Note 9) | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Preferred stock (undesignated), $0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding at June 30, 2024 and December 31, 2023 | — | — | ||||||
| Common stock, $0.0001 par value; 1,000,000,000 shares authorized, 119,442,635 shares issued and outstanding at June 30, 2024; 110,160,684 shares issued and outstanding at December 31, 2023 | 12 | 11 | ||||||
| Additional paid-in capital | 963,454 | 909,539 | ||||||
| Accumulated other comprehensive loss | (12 | ) | (13 | ) | ||||
| Accumulated deficit | (822,812 | ) | (732,069 | ) | ||||
| Total stockholders’ equity | 140,642 | 177,468 | ||||||
| Total liabilities, preferred stock and stockholders’ equity | $ | 177,346 | $ | 229,181 | ||||
| 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, | |||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue, net | $ | 2,264 | $ | — | $ | 2,264 | $ | — | ||||||||
| Total revenue | 2,264 | — | 2,264 | — | ||||||||||||
| Operating costs and expenses: | ||||||||||||||||
| Cost of product revenue | 88 | — | 88 | — | ||||||||||||
| Research and development (1) | 30,334 | 43,618 | 61,494 | 70,819 | ||||||||||||
| Acquired in-process research and development (2) | — | 150 | — | 975 | ||||||||||||
| Selling, general and administrative | 21,089 | 10,107 | 36,018 | 21,152 | ||||||||||||
| Total operating costs and expenses | 51,511 | 53,875 | 97,600 | 92,946 | ||||||||||||
| Loss from operations | (49,247 | ) | (53,875 | ) | (95,336 | ) | (92,946 | ) | ||||||||
| Other income: | ||||||||||||||||
| Other income, net | 2,000 | 3,647 | 4,593 | 7,397 | ||||||||||||
| Total other income, net | 2,000 | 3,647 | 4,593 | 7,397 | ||||||||||||
| Net loss | (47,247 | ) | (50,228 | ) | (90,743 | ) | (85,549 | ) | ||||||||
| Other comprehensive income (loss) | ||||||||||||||||
| Unrealized gain on available-for-sale securities, net of tax | — | 93 | 1 | 250 | ||||||||||||
| Comprehensive loss | $ | (47,247 | ) | $ | (50,135 | ) | $ | (90,742 | ) | $ | (85,299 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.40 | ) | $ | (0.46 | ) | $ | (0.77 | ) | $ | (0.78 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 119,362,670 | 109,450,071 | 117,490,439 | 109,119,630 | ||||||||||||
(1) Includes related-party amounts of $1,131 and $2,266 for the three and six months ended June 30, 2024, respectively, and $2,258 and $5,218 for the three and six months ended June 30, 2023, respectively.
(2) Includes no related-party amounts for both the three and six months ended June 30, 2024, and $0 and $375 for the three and six months ended June 30, 2023, respectively.
| Last Trade: | US$0.67 |
| Daily Change: | 0.08 14.24 |
| Daily Volume: | 2,043,805 |
| Market Cap: | US$80.500M |
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