Latest News by Industry
Novel monoclonal antibody combination candidate (NVD200) on track to advance into clinical trials in Q1 2023
$419 million in cash, cash equivalents and marketable securities expected to support operating runway into Q2 2024
Conference call scheduled for Thursday, November 10that 4:30 p.m. ET
WALTHAM, Mass., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) a clinical-stage biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases, today announced financial results and business highlights for the third quarter ended September 30, 2022.
“It has been a productive quarter starting with a corporate rebrand emphasizing our commitment to efficiently generating antibodies that transcend the limits of naturally occurring immunity to prevent and treat life-threatening viral infections, including COVID-19,” said David Hering, chief executive officer of Invivyd. “Innovation in the monoclonal antibody space is desperately needed to create new options that overcome diminishing efficacy due to the rapidly changing nature of the virus. Leveraging our integrated discovery platform, we have engineered NVD200, our recently announced combination antibody product candidate which has potential to provide broad and durable protection against currently circulating and future COVID-19 variants. We look forward to advancing this important program into the clinic in the first quarter of 2023.”
Third Quarter and Recent Business Highlights
Third Quarter 2022 Financial Results
Conference Call
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 invivyd.com/investors. 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 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 Invivyd
(Nasdaq: IVVD)
Invivyd, formerly Adagio Therapeutics (Nasdaq: ADGI), is a biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases. The company is developing antibodies to transcend the limits of naturally occurring immunity and provide superior protection from viral diseases, beginning with COVID-19. 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 a high barrier to viral escape. The company’s integrated discovery platform is generating a robust pipeline of products for use in both prevention and treatment of disease. NVD200, Invivyd’s first antibody combination product candidate for the prevention and treatment of COVID-19, includes a re-engineered version of adintrevimab, an investigational monoclonal antibody which demonstrated clinically meaningful results against multiple variants of concern in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19, prior to the emergence of Omicron. The safety and efficacy of adintrevimab have not been established. The company also has multiple discovery stage candidates for the prevention of seasonal influenza. Visit www.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 including the expectation of continued evolution and emergence of new variants and subvariants; our ongoing research and clinical development plans and the timing thereof; our plans to advance adintrevimab, NVD200, or other early stage candidates as a potential prophylaxis and treatment option for COVID-19, including disease caused by most variants, as either a single or combination agent, including our intention to initiate clinical development of NVD200 in the first quarter of 2023; the potential for adintrevimab and NVD200 to demonstrate activity against predominant SARS-CoV-2 variant(s), provide durable and broad protection against currently circulating and future COVID-19 variants, and to overcome diminishing efficacy due to the rapidly changing nature of the virus in the U.S. and globally; our expected cash runway, our plans, technology and resources to develop therapeutic or preventative options for other infectious diseases, such as additional coronaviruses and seasonal influenza, in the U.S. and globally; the benefit of the increased leased laboratory space to allow for additional discovery and development capabilities and output from our integrated discovery platform; the implementation and impact of the restructuring plan and the intended benefits to the company from the plan; and other statements that are not historical fact. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: we may not realize the expected benefits from the restructuring plan, including accelerated timelines and enhanced discovery and development process and outcomes, and we may incur costs associated with implementation of the restructuring plan in addition to those currently contemplated; potential disruptions to the business as a result of the restructuring plan and the management transition; we may not realize discovery or development benefits from the additional leased lab space; the impacts of the COVID-19 pandemic on our business and those of our collaborators, our clinical trials and our financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of adintrevimab, NVD200, or other pipeline candidates or combination of candidates based on neutralizing activity in pre-clinical 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 our discussions with regulatory authorities concerning our clinical trials; whether adintrevimab, NVD200, or any other pipeline candidate or combination of candidates is able to demonstrate activity against predominant SARS-CoV-2 variant(s), provide durable and broad protection against currently circulating and future COVID-19 variants, or overcome diminishing efficacy due to the rapidly changing nature of the virus in the U.S. and globally; whether we are able to successfully submit an emergency use authorization in the future, and the outcome of any such emergency use authorization submission; whether research and development efforts will improve efficacy of adintrevimab against predominant variants or identify additional monoclonal antibodies or combination of antibodies for the prevention and treatment of COVID-19 and other infectious diseases; whether research and development efforts will identify and result in safe and effective therapeutic or preventative options for other infectious diseases in the U.S. or globally and whether we have adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause our 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 our Annual Report on Form 10-K for the year ended December 31, 2021 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, each filed with the Securities and Exchange Commission (the “SEC”), our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 to be filed after the issuance of this release, and in our other filings with the SEC, and in Invivyd’s 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.
Contacts
Media Contact:
Tony Berry, Evoke Canale
774-317-0422
anthony.berry@evokegroup.com
Investor Contact:
Chris Brinzey, ICR Westwicke
339-970-2843
chris.brinzey@westwicke.com
INVIVYD, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share and per share amounts) September 30,
2022 December 31,
2021 Assets Current assets: Cash and cash equivalents$278,152 $542,224 Marketable securities 140,517 49,194 Prepaid expenses and other current assets 2,927 25,293 Total current assets 421,596 616,711 Property and equipment, net 1,429 83 Operating lease right-of-use assets 1,486 — Other non-current assets 236 3,297 Total assets$424,747 $620,091 Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit) Current liabilities: Accounts payable$16,770 $5,783 Accrued expenses 28,974 56,277 Operating lease liability, current 329 — Other current liabilities 53 — Total current liabilities 46,126 62,060 Early-exercise liability 1 6 Operating lease liability, non-current 1,177 — Other non-current liability — 6 Total liabilities 47,304 62,072 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 September 30, 2022
and December 31, 2021 — — Common stock, $0.0001 par value; 1,000,000,000 shares authorized,
108,957,401 shares issued and outstanding at September 30, 2022;
1,000,000,000 shares authorized, 111,251,660 shares issued and
110,782,909 shares outstanding at December 31, 2021 11 11 Treasury stock, at cost; 0 shares and 468,751 shares at
September 30, 2022 and December 31, 2021, respectively — — Additional paid-in capital 866,238 850,125 Accumulated other comprehensive income (loss) 46 (8)Accumulated deficit (488,852) (292,109)Total stockholders’ equity (deficit) 377,443 558,019 Total liabilities, convertible preferred stock and stockholders’ equity (deficit)$424,747 $620,091
INVIVYD, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(In thousands, except share and per share amounts) Three Months Ended September 30, Three Months Ended September 30, Nine Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Operating expenses: Research and development(1)$30,131 $45,366 $159,295 $114,465 Acquired in-process research and development(2) 4,000 4,000 4,000 7,500 Selling, general and administrative 13,200 11,052 36,524 21,853 Total operating expenses 47,331 60,418 199,819 143,818 Loss from operations (47,331) (60,418) (199,819) (143,818)Other income (expense): Other income (expense), net 2,244 43 3,076 70 Total other income (expense), net 2,244 43 3,076 70 Net loss (45,087) (60,375) (196,743) (143,748)Other comprehensive income (loss) Unrealized gain on available-for-sale securities, net of tax 46 3 54 3 Comprehensive loss$(45,041) $(60,372) $(196,689) $(143,745)Net loss per share attributable to common stockholders, basic and diluted$(0.42) $(0.98) $(1.82) $(7.06)Weighted-average common shares outstanding, basic and diluted 108,420,674 61,297,086 108,154,397 20,346,771 (1)Includes related-party amounts of $1,742 and $6,027 for the three and nine months ended September 30, 2022, respectively, and $1,826 and $2,261 for the three and nine months ended September 30, 2021, respectively.(2)Includes related-party amounts of $4,000 for both the three and nine months ended September 30, 2022, and $4,000 and $7,500 for the three and nine months ended September 30, 2021, respectively.