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 September 30, 2023, and recent
business highlights.
“I am immensely proud of our team and their remarkable
performance throughout the third quarter. In September, less than
six months after initiating a Phase 1 clinical trial, we announced
we had dosed the first participant in CANOPY, our Phase 3 pivotal
clinical trial investigating VYD222 for the prevention of
symptomatic COVID-19. Today we are pleased to announce that we have
completed enrollment in the CANOPY trial and continue to expect to
have initial primary endpoint data in late 2023 or early Q1 2024,”
said Dave Hering, Chief Executive Officer of Invivyd. “Given the
urgent unmet medical need, we continue to aim to submit an
application for EUA to the U.S. Food and Drug Administration (FDA)
as soon as practicable.”
Mr. Hering added, “In preparation for a potential EUA, we have
been engaged in commercial planning for an anticipated market entry
of VYD222 in 2024. With an estimated total addressable market of
more than 9 million immunocompromised individuals in the U.S., our
teams have been developing and refining our strategy, which will
initially focus on serving the highest risk immunocompromised
people. Furthermore, we continue to have constructive dialogue with
the FDA regarding potential pathways that would enable us to fully
leverage our INVYMAB platform approach to rapidly and perpetually
deliver monoclonal antibody candidates designed to keep pace with
viral evolution.”
Recent VYD222 Program Updates:
- Enrollment completed in CANOPY
Phase 3 pivotal clinical trial of VYD222: Invivyd enrolled
approximately 750 participants across two cohorts, including
approximately 300 individuals who are significantly
immunocompromised in Cohort A and approximately 450 individuals at
risk of exposure to SARS-CoV-2 in Cohort B. The company plans to
include Day 28 serum neutralizing titers as calculated from the
pharmacokinetic concentrations from the immunocompromised cohort,
along with safety data from both cohorts, as part of the clinical
data package for a potential EUA submission in the U.S.
- VYD222 shows
in vitro neutralizing activity against
recent SARS-CoV-2 variants tested: Recent in vitro
pseudovirus testing of VYD222 continues to show neutralizing
activity against Omicron variants including XBB.1.5.10/EG.5.
Importantly, VYD222 shows in vitro neutralizing activity against
SARS-CoV-2 variants that harbor the F456L mutation in the spike
glycoprotein, which is currently estimated to be present in
approximately 80% of CDC-tracked variants.
- Commercial preparations
underway for VYD222: The company is actively preparing for
the commercial launch of VYD222 in the U.S., if authorized. The
company has conducted market research to further refine its
understanding of the different immunocompromised populations and
mapped the market access landscape, among other go-to-market
planning activities. In addition, Invivyd has initiated the
manufacturing of VYD222 commercial supply.
Recent Corporate Updates:
- William Duke appointed Chief
Financial Officer: On September 5, 2023, Invivyd announced
the appointment of William (Bill) Duke as Chief Financial Officer.
Mr. Duke has more than 25 years of finance, accounting, and
operations experience, including over a decade of senior leadership
experience in the biotechnology industry.
- Company continues to advance
INVYMAB™, its propriety platform approach: In the third
quarter, Invivyd filed a trademark application with the U.S. Patent
and Trademark office for INVYMAB™, the company’s platform approach
which combines state-of-the-art viral surveillance and predictive
modeling with advanced antibody engineering. Leveraging its INVYMAB
platform approach, the company continues to advance its preclinical
work optimizing and characterizing potential future anti-SARS-CoV-2
monoclonal antibody candidates.
- Presented VYD222 Phase 1
clinical trial data at IDWeek 2023 (Abstract
#1363): On October 13, 2023, the company delivered a
poster presentation at IDWeek which updated previously released
safety data showing that, as of September 6, 2023, a single
administration of VYD222 or placebo was generally well-tolerated at
all three dose levels tested (1500 mg, 2500 mg and 4500 mg) with no
serious adverse events reported (N=30).
Third Quarter 2023 Financial Results:
- Cash position: Cash, cash equivalents and
marketable securities were $264.9 million as of September 30,
2023.
- Cash runway: Based on current operating
plans, Invivyd continues to expect 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 $30.2 million for
the quarter ended September 30, 2023, compared to $34.1 million for
the comparable period of 2022. The decrease is primarily
attributable to higher clinical trial costs in 2022 due to ongoing
adintrevimab clinical trials, with no comparable costs during the
same period in 2023 due to the wind-down of adintrevimab clinical
trials, partially offset by clinical trial costs associated with
dosing of our CANOPY clinical trial in September 2023.
- Selling, general & administrative (SG&A)
expenses: SG&A expenses remained relatively
consistent at $12.9 million for the quarter ended September 30,
2023, compared to $13.2 million for the comparable period of
2022.
- Net loss and net loss per share: Net loss
was $39.4 million for the quarter ended September 30, 2023,
compared to $45.1 million for the comparable period in 2022. Basic
and diluted net loss per share was $0.36 for the quarter ended
September 30, 2023, compared to $0.42 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 CANOPY The CANOPY pivotal
clinical trial is an ongoing Phase 3 clinical trial designed to
evaluate protection against symptomatic COVID-19 after receiving
VYD222. The safety, tolerability, pharmacokinetic profile, and
immunogenicity of VYD222 will also be evaluated. In November 2023,
Invivyd announced the completion of enrollment in the CANOPY
clinical trial, with approximately 750 participants enrolled in two
cohorts (A and B) across multiple trial sites in the
U.S. Cohort A enrolled approximately 300 participants who are
significantly immunocompromised. For this cohort, the company will
use serum neutralizing titers against relevant SARS-CoV-2 variants
at Day 28 as the primary efficacy endpoint, which will be
calculated based on the pharmacokinetic concentration of VYD222
from the immunocompromised participants and the IC50 value for
VYD222 against relevant SARS-CoV-2 variants. The primary efficacy
analysis will use an immunobridging approach comparing data
obtained in the CANOPY clinical trial 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 received VYD222 administered
via intravenous (IV) infusion.
Cohort B enrolled approximately 450 participants at risk of
exposure to SARS-CoV-2. The primary endpoint is safety and
tolerability. Cohort B participants were randomized 2:1 to receive
VYD222 or placebo administered via IV infusion.
Invivyd is evaluating the 4500 mg dose of VYD222 in the CANOPY
clinical trial. The company expects to have initial primary
endpoint data by late 2023 or early Q1 2024.
About VYD222VYD222 is a broadly neutralizing,
half-life extended monoclonal antibody (mAb) candidate in
development for the prevention of symptomatic COVID-19 in
vulnerable populations, such as immunocompromised people. Globally,
there are millions of immunocompromised people, with more than 9
million in the U.S. alone who may not adequately respond to
COVID-19 vaccination, increasing their risk for severe outcomes
from COVID-19. Currently, there are no monoclonal antibodies
authorized or approved in the U.S. for the prevention of
symptomatic COVID-19. VYD222 was designed for broad activity
and has demonstrated in vitro neutralizing activity
against various pre-Omicron and Omicron variants, such as XBB.1.5,
XBB.1.16, and XBB.1.5.10, an Omicron variant that has the same
spike glycoprotein sequence as EG.5. VYD222 was engineered from
adintrevimab, Invivyd’s investigational mAb that has a robust
safety data package and demonstrated clinically meaningful results
in global Phase 2/3 clinical trials for both the prevention and
treatment of COVID-19.
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. The company’s proprietary INVYMAB™
platform approach combines state-of-the-art viral surveillance and
predictive modeling with advanced antibody engineering. Leveraging
its INVYMAB platform approach, 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 progress and timing of the company’s ongoing
research and clinical development activities, including with
respect to VYD222; the timing of anticipated initial primary
endpoint data from the CANOPY Phase 3 pivotal clinical trial; the
company’s plans to submit an application for EUA in the U.S. as
soon as practicable; the company’s expectations regarding the size
of target patient populations and the potential market opportunity
for its product candidates; the anticipated commercial launch of
VYD222, if authorized, in the U.S.; the potential of the company’s
INVYMAB platform approach to rapidly, serially generate new
antibodies to address viral threats; the company’s dialogue with
the FDA regarding potential pathways that would enable the company
to fully leverage its INVYMAB platform approach; 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 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 timing and progress of the company’s discovery,
preclinical and clinical development activities, including the
company’s ability to generate the data needed from the CANOPY
clinical trial to support a potential EUA submission for VYD222;
whether the company is able to successfully submit an EUA in the
future, and the outcome of any such EUA submission; 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; potential variability in neutralizing activity
of product candidates tested in different assays, such as
pseudovirus assays and authentic assays; 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; 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; variability of results in
models used to predict activity against SARS-CoV-2 variants of
concern; 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 is able to demonstrate and sustain neutralizing activity
against predominant SARS-CoV-2 variants, particularly in the face
of viral evolution; 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.
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:
Scott Young(781) 208-1747syoung@invivyd.com
Gabriella Linville-Engler(781) 208-0160gengler@invivyd.com
INVIVYD, INC.CONDENSED
CONSOLIDATED BALANCE
SHEETS(UNAUDITED)(In thousands,
except share and per share amounts)
|
|
September 30,2023 |
|
|
December 31,2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
181,822 |
|
|
$ |
92,076 |
|
Marketable securities |
|
|
83,063 |
|
|
|
279,915 |
|
Prepaid expenses and other current assets |
|
|
5,218 |
|
|
|
4,926 |
|
Total current assets |
|
|
270,103 |
|
|
|
376,917 |
|
Property and equipment, net |
|
|
2,002 |
|
|
|
2,282 |
|
Operating lease right-of-use
assets |
|
|
2,625 |
|
|
|
3,777 |
|
Other non-current assets |
|
|
187 |
|
|
|
191 |
|
Total assets |
|
$ |
274,917 |
|
|
$ |
383,167 |
|
Liabilities, Preferred
Stock and Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
9,168 |
|
|
$ |
1,517 |
|
Accrued expenses |
|
|
15,958 |
|
|
|
21,911 |
|
Operating lease liabilities, current |
|
|
1,638 |
|
|
|
1,559 |
|
Other current liabilities |
|
|
27 |
|
|
|
44 |
|
Total current liabilities |
|
|
26,791 |
|
|
|
25,031 |
|
Operating lease liabilities,
non-current |
|
|
927 |
|
|
|
2,165 |
|
Other non-current liability |
|
|
700 |
|
|
|
— |
|
Early-exercise liability |
|
|
— |
|
|
|
1 |
|
Total liabilities |
|
|
28,418 |
|
|
|
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 September
30, 2023 and December 31, 2022 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 1,000,000,000 shares authorized,
109,846,329 shares issued and outstanding at September 30, 2023;
109,044,046 shares issued and outstanding at December 31, 2022 |
|
|
11 |
|
|
|
11 |
|
Additional paid-in capital |
|
|
904,905 |
|
|
|
889,657 |
|
Accumulated other comprehensive
loss |
|
|
(2 |
) |
|
|
(272 |
) |
Accumulated deficit |
|
|
(658,415 |
) |
|
|
(533,426 |
) |
Total stockholders’ equity |
|
|
246,499 |
|
|
|
355,970 |
|
Total liabilities, preferred stock and stockholders’ equity |
|
$ |
274,917 |
|
|
$ |
383,167 |
|
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, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development(1) |
|
$ |
25,574 |
|
|
$ |
30,131 |
|
|
$ |
96,393 |
|
|
$ |
159,295 |
|
Acquired in-process research and development(2) |
|
|
4,600 |
|
|
|
4,000 |
|
|
|
5,575 |
|
|
|
4,000 |
|
Selling, general and administrative |
|
|
12,886 |
|
|
|
13,200 |
|
|
|
34,038 |
|
|
|
36,524 |
|
Total operating expenses |
|
|
43,060 |
|
|
|
47,331 |
|
|
|
136,006 |
|
|
|
199,819 |
|
Loss from operations |
|
|
(43,060 |
) |
|
|
(47,331 |
) |
|
|
(136,006 |
) |
|
|
(199,819 |
) |
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
Other income |
|
|
3,620 |
|
|
|
2,244 |
|
|
|
11,017 |
|
|
|
3,076 |
|
Total other income |
|
|
3,620 |
|
|
|
2,244 |
|
|
|
11,017 |
|
|
|
3,076 |
|
Net loss |
|
|
(39,440 |
) |
|
|
(45,087 |
) |
|
|
(124,989 |
) |
|
|
(196,743 |
) |
Other comprehensive income
(loss) |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on available-for-sale securities, net of tax |
|
|
20 |
|
|
|
46 |
|
|
|
270 |
|
|
|
54 |
|
Comprehensive loss |
|
$ |
(39,420 |
) |
|
$ |
(45,041 |
) |
|
$ |
(124,719 |
) |
|
$ |
(196,689 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(0.36 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.14 |
) |
|
$ |
(1.82 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
109,754,812 |
|
|
|
108,420,674 |
|
|
|
109,333,684 |
|
|
|
108,154,397 |
|
(1) Includes
related-party amounts of $1,448 and $6,666 for the three and
nine months ended September 30, 2023, respectively, and $1,742
and $6,027 for the three and nine months ended September 30,
2022, respectively.(2) Includes
related-party amounts of $4,600 and $4,975 for the three and nine
months ended September 30, 2023, respectively, and $4,000 for
both the three and nine months ended September 30, 2022.
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