Full Press Release Details
Invivyd Reports Second Quarter 2023 Financial Results and Business Highlights
August 10, 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 June 30, 2023, and recent business highlights.
I am very excited with the progress we made in the second quarter. On the heels of
positive initial data from our Phase 1 VYD222 clinical trial and productive conversations with the FDA on a rapid pathway to a potential EUA, we are working with urgency to initiate a pivotal clinical trial of VYD222 for the prevention of
symptomatic COVID-19, referred to as the CANOPY trial, said Dave Hering, Chief Executive Officer of Invivyd. With the size and efficient design of the CANOPY trial, including a primary efficacy
endpoint based on the analysis of serum neutralizing titers at Day 28, we believe that we can swiftly enroll the trial and generate the data necessary to enable a potential EUA submission. We ve continued to see strong interest from our
clinical sites and immunocompromised people, with more than 1,000 immunocompromised individuals now in our database of potentially eligible individuals, which speaks to the strong unmet medical need.
Recent VYD222 Program Updates:
B, the company expects to enroll approximately 450 participants at risk of exposure to SARS-CoV-2. The primary endpoint will be safety and tolerability. Secondary and
exploratory endpoints will include serum neutralizing titers and clinical efficacy. Cohort B participants will be randomized 2:1 to receive VYD222 or placebo administered via IV infusion.
Invivyd plans to initiate the CANOPY trial with the 4500 mg dose of VYD222. While the
company believes that all three VYD222 doses tested in the Phase 1 clinical trial (1500 mg, 2500 mg, and 4500 mg) have the potential to provide clinically meaningful protection against symptomatic COVID-19,
the company has decided to initiate the CANOPY trial with the VYD222 dose that provided the highest serum neutralizing titers against Omicron XBB.1.5. This decision was informed by the FDA s preference for a conservative serum neutralizing
titer benchmark and the 4500 mg VYD222 dose. The company believes that the 4500 mg dose has the potential to provide a significant duration of protection, while also providing protection against potential loss of neutralization activity as SARS-CoV-2 evolves over time.
The company expects to have
initial primary endpoint data from the CANOPY trial by approximately the end of 2023.
Recent Corporate Updates:
Second 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/. 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 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 company s plans to initiate a pivotal clinical trial of VYD222 (CANOPY)
using a surrogate endpoint to generate the clinical data needed to enable a potential EUA submission, and the timing of anticipated initial primary endpoint data from the CANOPY trial; the company s anticipated CANOPY trial design; the
possibility for VYD222 and anticipated follow-on mAb candidates designed to prevent COVID-19 to follow a development pathway for mAbs in the U.S. using a correlate of
protection in an immunobridging approach to a pivotal clinical trial, and the company s plans to utilize adintrevimab as the prototype mAb for VYD222; the company s progress advancing its platform and pipeline of anti-SARS-CoV-2 mAbs; the company s expectations regarding the anticipated timeline of its cash runway; the company s ability 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; 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, if authorized or approved, could be used
in prevention or treatment of serious viral diseases, starting with COVID-19 and expanding into influenza and other high-need indications; 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: the ability to gain complete alignment with
the applicable regulatory authorities on the clinical trial design and development pathway for VYD222, including the use of an immunobridging pathway in the U.S., and the timing thereof; the timing and progress of the company s discovery,
preclinical and clinical development activities, including the company s ability to rapidly initiate a VYD222 pivotal clinical; 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 product
candidates based on neutralizing activity in preclinical studies; the risk that results of preclinical studies or clinical trials may not be predictive of future results in connection with current or future clinical trials; 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; whether VYD222 or any other product candidate or combination of candidates is able to demonstrate and sustain
neutralizing activity against predominant SARS-CoV-2 variants, particularly in the face of viral evolution; whether VYD222 or other product candidates will be
high-quality, long-lasting antibodies that resist viral escape; whether the company is able to successfully submit an EUA in the future, and the outcome of any such EUA 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 (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
Kate Burdick, Evoke Canale
Chris Brinzey, ICR Westwicke
CONDENSED CONSOLIDATED BALANCE SHEETS
thousands, except share and per share amounts)
| June 30, 2023 | December 31, 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 121,947 | $ | 92,076 | ||||
| Marketable securities | 176,483 | 279,915 | ||||||
| Prepaid expenses and other current assets | 11,556 | 4,926 | ||||||
| Total current assets | 309,986 | 376,917 | ||||||
| Property and equipment, net | 2,123 | 2,282 | ||||||
| Operating lease right-of-use assets | 3,014 | 3,777 | ||||||
| Other non-current assets | 291 | 191 | ||||||
| Total assets | $ | 315,414 | $ | 383,167 | ||||
| Liabilities, Preferred Stock and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,112 | $ | 1,517 | ||||
| Accrued expenses | 26,744 | 21,911 | ||||||
| Operating lease liabilities, current | 1,611 | 1,559 | ||||||
| Other current liabilities | 38 | 44 | ||||||
| Total current liabilities | 32,505 | 25,031 | ||||||
| Operating lease liabilities, non-current | 1,346 | 2,165 | ||||||
| Early-exercise liability | 1 | |||||||
| Total liabilities | 33,851 | 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 June 30, 2023 and December 31, 2022 | ||||||||
| Common stock, $0.0001 par value; 1,000,000,000 shares authorized, 109,570,333 shares issued and outstanding at June 30, 2023; 109,044,046 shares issued and outstanding at December 31, 2022 | 11 | 11 | ||||||
| Additional paid-in capital | 900,549 | 889,657 | ||||||
| Accumulated other comprehensive loss | (22 | ) | (272 | ) | ||||
| Accumulated deficit | (618,975 | ) | (533,426 | ) | ||||
| Total stockholders equity | 281,563 | 355,970 | ||||||
| Total liabilities, preferred stock and stockholders equity | $ | 315,414 | $ | 383,167 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
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, | |||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development(1) | $ | 43,618 | $ | 37,129 | $ | 70,819 | $ | 129,164 | ||||||||
| Acquired in-process research and development(2) | 150 | 975 | ||||||||||||||
| Selling, general and administrative | 10,107 | 14,620 | 21,152 | 23,324 | ||||||||||||
| Total operating expenses | 53,875 | 51,749 | 92,946 | 152,488 | ||||||||||||
| Loss from operations | (53,875 | ) | (51,749 | ) | (92,946 | ) | (152,488 | ) | ||||||||
| Other income: | ||||||||||||||||
| Other income | 3,647 | 759 | 7,397 | 832 | ||||||||||||
| Total other income | 3,647 | 759 | 7,397 | 832 | ||||||||||||
| Net loss | (50,228 | ) | (50,990 | ) | (85,549 | ) | (151,656 | ) | ||||||||
| Other comprehensive income (loss) | ||||||||||||||||
| Unrealized gain on available-for-sale securities, net of tax | 93 | 250 | 8 | |||||||||||||
| Comprehensive loss | $ | (50,135 | ) | $ | (50,990 | ) | $ | (85,299 | ) | $ | (151,648 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.46 | ) | $ | (0.47 | ) | $ | (0.78 | ) | $ | (1.40 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 109,450,071 | 108,166,890 | 109,119,630 | 108,019,051 |