Invivyd Reports Second Quarter 2023 Financial Results and Business Highlights
11 August 2023 - 6:01AM
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:
- Plans to initiate VYD222
pivotal clinical trial using a surrogate endpoint to
generate the clinical
data needed to
enable a potential
emergency use authorization
(EUA)
submission: In a pivotal clinical
trial of VYD222, referred to as the CANOPY trial, Invivyd plans to
enroll approximately 750 participants across two cohorts in
parallel. Cohort A is expected to enroll approximately 300
participants who are significantly immunocompromised. For Cohort A,
the company plans to use serum neutralizing titers against relevant
SARS-CoV-2 variants at Day 28 as the primary efficacy endpoint. The
primary efficacy analysis will use an immunobridging approach
comparing data obtained in the CANOPY trial for VYD222 to certain
historical data from the company’s previous Phase 2/3 clinical
trial of adintrevimab for the prevention of symptomatic COVID-19,
in which serum neutralizing titers correlated with observed
clinical efficacy. All Cohort A participants will receive VYD222
administered via IV infusion.In Cohort 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.
- Reported positive initial Phase
1 VYD222 clinical trial
data: In June and July 2023, Invivyd announced
positive initial data from the ongoing Phase 1 healthy volunteer
clinical trial of VYD222. The initial Phase 1 data showed a
favorable safety and tolerability profile, as well as robust serum
neutralizing titers against Omicron XBB.1.5 at Day 7 from all three
dose levels tested (1500 mg, 2500 mg, and 4500 mg). Previous
COVID-19 vaccine and monoclonal antibody (mAb) clinical trials,
including the company’s past Phase 2/3 adintrevimab clinical trial,
have demonstrated that serum neutralizing titers are correlated
with the prevention of symptomatic COVID-19.
- Reached general alignment with
FDA on pathway to potential EUA for VYD222 and anticipated
follow-on mAb candidates designed to prevent COVID-19:
Based on FDA feedback, the use of a correlate of protection, or a
surrogate of clinical efficacy, in an immunobridging approach to a
pivotal clinical trial may be a reasonable approach to support an
EUA for new mAb candidates when clinical trial data from a
“prototype” mAb are available, provided that certain criteria are
met. Invivyd plans to leverage its previous candidate,
adintrevimab, as the prototype mAb for VYD222.
Recent Corporate
Updates:
- Continued progress advancing
the company’s platform and pipeline of anti-SARS-CoV-2
mAbs: As part of its commitment to serial innovation,
Invivyd is continuously monitoring SARS-CoV-2 viral evolution and
leveraging its predictive modeling, B-cell mining and antibody
engineering capabilities to identify and optimize potential next
generation mAb candidates. The company continues to advance its
preclinical work characterizing potential future anti-SARS-CoV-2
mAb candidates.
- Appointed Sara Cotter to
board of
directors: In July 2023, Invivyd
appointed Sara Cotter to its board of directors. Ms. Cotter brings
extensive leadership experience spanning healthcare investment
management and drug development, including experience as the
founder and chief executive officer of Levo Therapeutics, Inc.
Second Quarter 2023
Financial Results:
- Cash
position: Cash, cash
equivalents and marketable securities were $298.4 million as of
June 30, 2023.
- Cash
runway: Based on current
operating plans, Invivyd expects its existing total cash, cash
equivalents and marketable securities will enable the company to
fund its operating expenses into the fourth quarter of 2024,
excluding potential contribution of commercial product revenue if a
mAb candidate is authorized or approved.
- Research &
development (R&D)
expenses (including
in-process
research &
development): R&D
expenses were $43.8 million for the quarter ended June 30, 2023,
compared to $37.1 million for the comparable period of 2022. This
increase is attributable to higher contract manufacturing costs
driven by VYD222 commercial manufacturing, partially offset by a
decrease in adintrevimab-related contract manufacturing and
contract research activities.
- Selling, general
& administrative
(SG&A)
expenses: SG&A expenses
were $10.1 million for the quarter ended June 30, 2023, compared to
$14.6 million for the comparable period of 2022. This decrease is
attributable primarily to reduced consulting costs, professional
fees and public company costs.
- Net loss and
net loss
per share: Net loss
was $50.2 million for the quarter ended June 30, 2023, compared to
$51.0 million for the comparable period in 2022. Basic and diluted
net loss per share was $0.46 for the quarter ended June 30, 2023,
compared to $0.47 for the comparable period in 2022.
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
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.
About InvivydInvivyd, 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 this press
release.
Contacts
Media Contact:Kate Burdick, Evoke
Canale860-462-1569kate.burdick@evokegroup.com
Investor Contact:Chris Brinzey, ICR
Westwicke339-970-2843chris.brinzey@westwicke.com
|
|
INVIVYD,
INC.CONDENSED CONSOLIDATED
BALANCE SHEETS(UNAUDITED)(In
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 |
|
|
|
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, |
|
|
|
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 |
|
(1) |
Includes related-party amounts of $2,258 and $5,218 for the
three and six months ended June 30, 2023, respectively, and
$2,285 and $4,285 for the three and six months ended June 30,
2022, respectively. |
(2) |
Includes related-party amounts of $0 and $375 for the three and six
months ended June 30, 2023, respectively, and includes no
related-party amounts for both the three and six months ended
June 30, 2022. |
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