Full Press Release Details
Invivyd Reports First Quarter 2023 Financial Results and Business Highlights
Completed dosing of the Phase 1 clinical trial of VYD222, a broadly neutralizing monoclonal antibody (mAb) candidate being developed to
protect immunocompromised people from COVID-19
Initial data readouts from Phase 1 VYD222
clinical trial planned for Q2 with additional clinical readouts from the VYD222 program anticipated in 2023
clinical research in Science Translational Medicine that provides strong scientific rationale for using surrogate endpoints to expedite clinical development of mAbs for the prevention of symptomatic COVID-19
Well capitalized with $333.4 million in cash, cash equivalents and marketable securities expected to support operating runway
into second half of 2024 excluding potential contribution of commercial product revenue
Conference call scheduled for Thursday, May
11th at 4:30 p.m. ET
Waltham, MA May 11, 2023 Invivyd,
Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced financial results for the quarter ended March 31, 2023, and recent business
We ve made great strides in the first part of 2023, including the swift progress in our Phase 1 VYD222 clinical trial underway in
Australia, the FDA clearance of our VYD222 IND application, and the continued advancement of our work engineering and characterizing potential next-generation mAb candidates targeting
SARS-CoV-2, said Dave Hering, chief executive officer of Invivyd. These are all important steps in our strategy to serially innovate at a speed that matches
the pace of SARS-CoV-2 viral evolution. With the previously authorized anti-SARS-CoV-2
mAbs losing activity against variants of concern, our mission is critical for the millions of immunocompromised people who may not generate adequate protection from COVID-19 vaccines and are at increased risk
for severe outcomes.
Mr. Hering continued, We look forward to continuing to engage with global regulators with the aim to establish new
clinical and regulatory paradigms that reflect the rate of SARS-CoV-2 viral evolution. Leveraging clinical data from our previous adintrevimab trial, we are proud to
have recently published landmark research which showed that serum virus neutralizing titers predicted protection against symptomatic SARS-CoV-2 infection, a finding that
we believe has the potential to substantially accelerate our clinical development of VYD222. We believe that the use of surrogate endpoints will be an important component of new paradigms.
Recent VYD222 Program Updates
Recent Corporate Updates
First Quarter 2023 Financial Results
In connection with this announcement,
Invivyd will host a conference call and webcast today at 4:30 p.m. ET. A live audio webcast will be available at https://investors.invivyd.com/. Interested parties may also 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 in the investor section of the company s website approximately two hours after the end of the call. Those who plan on
participating are advised to join 15 minutes prior to the start time.
Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company on a mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable
people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2. Invivyd s technology works at the intersection of evolutionary
virology, predictive modeling, and antibody engineering, and is designed to identify high-quality, long-lasting antibodies with the potential to resist viral escape. The company is generating a robust pipeline of product candidates which could be
used in prevention or treatment of serious viral diseases, starting with COVID-19 and expanding into influenza and other high-need indications. 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, the future of the COVID-19
landscape; the company s ongoing research and clinical development plans and the timing thereof, including with respect to the clinical development of VYD222; the timing of anticipated dosing completion and data readouts with respect to the
company s VYD222 program; the company s continued work engineering and characterizing potential next-generation mAb candidates targeting SARS-CoV-2; the
company s plans to continue to engage with global regulators with the aim to establish new clinical and regulatory paradigms, which may involve use of surrogate endpoints, which may accelerate clinical development of mAbs designed to prevent COVID-19; the potential for the
adintrevimab clinical data to support accelerated development of VYD222; the company s strategy to serially innovate, plans to advance a stream of mAb candidates designed to keep pace with SARS-CoV-2 viral evolution, and progress developing the company s platform and pipeline of
anti-SARS-CoV-2 mAbs; the potential for VYD222 or other product candidates to demonstrate activity against predominant SARS-CoV-2 variant(s); the company s expectations regarding the anticipated timeline of its cash runway; anticipated benefits to the company of recent executive officer appointments; the company s
ability to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats; the potential for VYD222 and other product candidates to be high-quality, long-lasting
antibodies with the potential to resist viral escape; the company s plans to generate a robust pipeline of product candidates which could be used in prevention or treatment of serious viral threats, starting with
COVID-19 and expanding into influenza and other high-need indications; and other statements that are not historical fact. We 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: the ability to gain alignment with the applicable regulatory authorities on the clinical trial design and development
pathway for VYD222 and the timing thereof; the timing and progress of the company s discovery, preclinical and clinical development activities; the ability of the company to generate and utilize tools to discover and develop a pipeline of
antibodies to treat current and potential future SARS-CoV-2 variants; the impacts of the COVID-19 pandemic on the company s
business and those of its collaborators, the company s clinical trials and its financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of VYD222 or
other pipeline product candidates based on neutralizing activity in preclinical studies; variability of results in models used to predict activity against SARS-CoV-2
variants of concern; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval
process, including the outcome of the company s discussions with regulatory authorities concerning its clinical trials and platform-based approach to development; whether VYD222 or any other product candidate or combination of candidates is
able to demonstrate and sustain neutralizing activity against predominant SARS-CoV-2 variant(s); whether VYD222 or other product candidates will be high-quality,
long-lasting antibodies with the potential to resist viral escape; whether the company is able to successfully submit an emergency use authorization in the future, and the outcome of any such emergency use authorization submission; whether the
company s research and development efforts will identify and result in safe and effective therapeutic options for infectious diseases other than COVID-19; 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, 2022 filed with the Securities and Exchange Commission (the
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. Such risks may be amplified by the impacts of the
COVID-19 pandemic. 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.
Kate Burdick, Evoke Canale
Chris Brinzey, ICR Westwicke
CONDENSED CONSOLIDATED BALANCE SHEETS
thousands, except share and per share amounts)
| March 31, 2023 | December 31, 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 126,473 | $ | 92,076 | ||||
| Marketable securities | 206,955 | 279,915 | ||||||
| Prepaid expenses and other current assets | 11,195 | 4,926 | ||||||
| Total current assets | 344,623 | 376,917 | ||||||
| Property and equipment, net | 2,252 | 2,282 | ||||||
| Operating lease right-of-use assets | 3,398 | 3,777 | ||||||
| Other non-current assets | 291 | 191 | ||||||
| Total assets | $ | 350,564 | $ | 383,167 | ||||
| Liabilities, Preferred Stock and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,913 | $ | 1,517 | ||||
| Accrued expenses | 14,501 | 21,911 | ||||||
| Operating lease liabilities, current | 1,585 | 1,559 | ||||||
| Other current liabilities | 58 | 44 | ||||||
| Total current liabilities | 22,057 | 25,031 | ||||||
| Operating lease liabilities, non-current | 1,758 | 2,165 | ||||||
| Early-exercise liability | 1 | |||||||
| Total liabilities | 23,815 | 27,197 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity (deficit): | ||||||||
| Preferred stock (undesignated), $0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding at March 31, 2023 and December 31, 2022 | ||||||||
| Common stock, $0.0001 par value; 1,000,000,000 shares authorized, 109,316,226 shares issued and outstanding at March 31, 2023; 109,044,046 shares issued and outstanding at December 31, 2022 | 11 | 11 | ||||||
| Additional paid-in capital | 895,600 | 889,657 | ||||||
| Accumulated other comprehensive loss | (115 | ) | (272 | ) | ||||
| Accumulated deficit | (568,747 | ) | (533,426 | ) | ||||
| Total stockholders equity | 326,749 | 355,970 | ||||||
| Total liabilities, preferred stock and stockholders equity | $ | 350,564 | $ | 383,167 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
thousands, except share and per share amounts)
| Three Months Ended March 31, | Three Months Ended March 31, | |||||||
| 2023 | 2022 | |||||||
| Operating expenses: | ||||||||
| Research and development (1) | $ | 27,201 | $ | 92,035 | ||||
| Acquired in-process research and development (2) | 825 | |||||||
| Selling, general and administrative | 11,045 | 8,704 | ||||||
| Total operating expenses | 39,071 | 100,739 | ||||||
| Loss from operations | (39,071 | ) | (100,739 | ) | ||||
| Other income: | ||||||||
| Other income | 3,750 | 73 | ||||||
| Total other income | 3,750 | 73 | ||||||
| Net loss | (35,321 | ) | (100,666 | ) | ||||
| Other comprehensive income (loss) | ||||||||
| Unrealized gain on available-for-sale securities, net of tax | 157 | 8 | ||||||
| Comprehensive loss | $ | (35,164 | ) | $ | (100,658 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.32 | ) | $ | (0.93 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 108,785,519 | 107,869,570 |