Full Press Release Details
INVIVYD REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS
WALTHAM, Mass., August 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.
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.
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.
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/
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.
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)
| 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 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
(In thousands, except share and per share amounts)
| Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 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 |