Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted
to delivering protection from serious viral infectious diseases,
today announced financial results for the fourth quarter and full
year ended December 31, 2024, and recent business highlights.
“We are pleased with the significant PEMGARDA™ revenue growth of
48% in the fourth quarter, reflecting increased provider awareness
and adoption,” said Bill Duke, Chief Financial Officer of Invivyd.
“We look forward to raising further awareness of PEMGARDA in the
healthcare community and working to achieve near-term
profitability. In parallel, we are advancing VYD2311, our next
generation monoclonal antibody that has demonstrated highly
promising Phase 1 clinical data and has the potential to offer an
improved route of administration to protect vulnerable patient
populations from COVID-19.”
“With our impressive fourth quarter growth as our catalyst, we
began 2025 with a newly transitioned, in-house sales force,” said
Tim Lee, Chief Commercial Officer. “Vulnerable patient populations
such as cancer patients, those undergoing or living with an organ
transplant, and those who are on immunosuppressive therapies are at
risk of the short-term and long-term systemic damage of COVID-19.
With hospitalizations and deaths from COVID-19 greater than
influenza and RSV combined, it’s imperative to keep COVID-19 at the
forefront of the minds of vulnerable patients and their healthcare
providers – including hematologists, transplant physicians,
infectious disease clinicians, rheumatologists and primary care
doctors.”
Recent Business Highlights
- PEMGARDA Neutralization Data Updates
- Continued, neutralization activity of PEMGARDA shown against
currently dominant SARS-CoV-2 variants LP.8.1, KP.3.1.1 and XEC,
comprising the majority of SARS-CoV-2 variants currently
circulating in the U.S. This aligns with Invivyd’s broader clinical
and virology data, which have consistently demonstrated structural
stability of the targeted epitope of PEMGARDA and prolonged
neutralizing activity against contemporary variants.
- LP.8.1 in vitro neutralization data provided to the U.S. Food
and Drug Administration (FDA)
- Regulatory Developments
- In February 2025, the FDA declined Invivyd’s request to expand
the existing emergency use authorization of PEMGARDA to include
treatment of mild-to-moderate COVID-19 for immunocompromised
patients who have no alternative therapeutic options. Invivyd has
submitted a response requesting that the FDA reconsider and looks
forward to meeting to discuss next steps.
- Partnership & Awareness Campaigns
- The company announced collaboration with renowned professional
football coach Jim Harbaugh to elevate awareness of the ongoing
impact of COVID-19 and options available to vulnerable
populations.
- Manufacturing & Supply
- VYD2311 commercial manufacturing has been substantially
completed.
- Minimal manufacturing expenses expected in 2025, contributing
to ongoing cost reductions.
Recent Pipeline Highlights
- Positive Phase 1 clinical data announced in February 2025 for
VYD2311, a next-generation monoclonal antibody for COVID-19
- Phase 1 clinical data, combined with antiviral assessment and
COVID-19 antiviral correlate of protection data, including
Invivyd's Phase 3 CANOPY clinical trial data for pemivibart,
support a potentially attractive clinical profile for VYD2311.
- VYD2311 pooled, blinded adverse events were mild or moderate
and thus far deemed unrelated to study drug or largely related to
injection site reaction or infusion reactions.
- In February 2025, the company announced that in vitro
neutralization potency of VYD2311 assessed across contemporary
SARS-CoV-2 variants tested showed an average 17-fold greater
neutralization potency than pemivibart.
- VYD2311 has also demonstrated stable epitope and clinically
meaningful in vitro neutralization against LP.8.1 providing further
validation of the company’s integrated technology platform’s
potential to produce monoclonal antibodies with broad and durable
viral protection along with improved drug properties.
Fourth Quarter and Full-Year 2024 Financial
Results
- Revenue: Reported full year 2024 net product
revenue of PEMGARDA of $25.4 million. Reported $13.8 million of net
product revenue of PEMGARDA in Q4 2024, marking a 48% increase when
compared to $9.3 million in Q3 2024.
- Cash Position: Cash and cash equivalents were
$69.3 million as of December 31, 2024.
- Research & Development (R&D) Expenses:
R&D expenses were $137.3 million for the year ended December
31, 2024, compared to $163.6 million (inclusive of in-process
R&D) for the comparable period in 2023. This decrease is
primarily attributable to lower personnel costs and commercial
manufacturing costs of PEMGARDA, partially offset by commercial
manufacturing costs of VYD2311 in 2024.
- Selling, General & Administrative (SG&A)
Expenses: SG&A expenses were $63.4 million for the
year ended December 31, 2024, compared to $49.1 million for the
comparable period in 2023. This increase is primarily attributable
to an increase in personnel costs and costs associated with
commercialization of PEMGARDA.
- Net Loss and Net Loss per Share: Net loss was
$169.9 million for the year ended December 31, 2024, compared to
$198.6 million for the comparable period in 2023. Basic and diluted
net loss per share was $1.43 for the year ended December 31, 2024,
compared to $1.81 for the comparable period in 2023.
About PEMGARDA
PEMGARDA™ (pemivibart) is a half-life extended investigational
monoclonal antibody (mAb). PEMGARDA was engineered from
adintrevimab, Invivyd’s investigational mAb that has a robust
safety data package and provided evidence of clinical efficacy in
global Phase 2/3 clinical trials for the prevention and treatment
of COVID-19. PEMGARDA has demonstrated in vitro neutralizing
activity against major SARS-CoV-2 variants, including JN.1,
KP.3.1.1, XEC and LP.8.1. PEMGARDA targets the SARS-CoV-2 spike
protein receptor binding domain (RBD), thereby inhibiting virus
attachment to the human ACE2 receptor on host cells.
PEMGARDA (pemivibart) injection (4500 mg), for intravenous use
is an investigational mAb that has not been approved, but has been
authorized for emergency use by the U.S. FDA under an EUA for the
pre-exposure prophylaxis (prevention) of COVID-19 in adults and
adolescents (12 years of age and older weighing at least 40 kg) who
have moderate-to-severe immune compromise due to certain medical
conditions or receipt of certain immunosuppressive medications or
treatments and are unlikely to mount an adequate immune response to
COVID-19 vaccination. Recipients should not be currently infected
with or have had a known recent exposure to an individual infected
with SARS-CoV-2.
PEMGARDA is not authorized for use for treatment of COVID-19 or
post-exposure prophylaxis of COVID-19. Pre-exposure prophylaxis
with PEMGARDA is not a substitute for vaccination in individuals
for whom COVID-19 vaccination is recommended. Individuals for whom
COVID-19 vaccination is recommended, including individuals with
moderate-to-severe immune compromise who may derive benefit from
COVID-19 vaccinations, should receive COVID-19 vaccination. In
individuals who have recently received a COVID-19 vaccine, PEMGARDA
should be administered at least 2 weeks after vaccination.
Anaphylaxis has been observed with PEMGARDA and the PEMGARDA
Fact Sheet for Healthcare Providers includes a boxed warning for
anaphylaxis. The most common adverse reactions included systemic
infusion-related reactions and hypersensitivity reactions, local
infusion site reactions, and infusion site infiltration or
extravasation. For additional information, please see the PEMGARDA
full product Fact Sheet for Healthcare Providers, including
important safety information and boxed warning.
To support the EUA for PEMGARDA, an immunobridging approach was
used to determine if PEMGARDA may be effective for pre-exposure
prophylaxis of COVID-19. Immunobridging is based on the serum virus
neutralizing titer-efficacy relationships identified with other
neutralizing human mAbs against SARS-CoV-2. This includes
adintrevimab, the parent mAb of pemivibart, and other mAbs that
were previously authorized for EUA. There are limitations of the
data supporting the benefits of PEMGARDA. Evidence of clinical
efficacy for other neutralizing human mAbs against SARS-CoV-2 was
based on different populations and SARS-CoV-2 variants that are no
longer circulating. Further, the variability associated with
cell-based EC50 value determinations, along with limitations
related to pharmacokinetic data and efficacy estimates for the mAbs
in prior clinical trials, impact the ability to precisely estimate
protective titer ranges. Additionally, certain SARS-CoV-2 viral
variants may emerge that have substantially reduced susceptibility
to PEMGARDA, and PEMGARDA may not be effective at preventing
COVID-19 caused by these SARS-CoV-2 viral variants.
The emergency use of PEMGARDA is only authorized for the
duration of the declaration that circumstances exist justifying the
authorization of the emergency use of drugs and biological products
during the COVID-19 pandemic under Section 564(b)(1) of the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the declaration is terminated or authorization revoked sooner.
PEMGARDA is authorized for use only when the combined national
frequency of variants with substantially reduced susceptibility to
PEMGARDA is less than or equal to 90%, based on available
information including variant susceptibility to PEMGARDA and
national variant frequencies.
About VYD2311
VYD2311 is a novel monoclonal antibody (mAb) candidate being
developed for COVID-19 to continue to address the urgent need for
new prophylactic and therapeutic options. The pharmacokinetic
profile and antiviral potency of VYD2311 may offer the ability to
deliver clinically meaningful titer levels through more
patient-friendly means such as an intramuscular route of
administration.
VYD2311 was engineered using Invivyd’s proprietary integrated
technology platform and is the product of serial molecular
evolution designed to generate an antibody optimized for
neutralizing contemporary virus lineages. VYD2311 leverages the
same antibody backbone as pemivibart, Invivyd’s investigational mAb
granted emergency use authorization in the U.S. for the
pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain
immunocompromised patients, and 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 the prevention and treatment of COVID-19.
About Invivyd
Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company
devoted to delivering protection from serious viral infectious
diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary
integrated technology platform unique in the industry designed to
assess, monitor, develop, and adapt to create best in class
antibodies. In March 2024, Invivyd received emergency use
authorization (EUA) from the U.S. FDA for a monoclonal antibody
(mAb) in its pipeline of innovative antibody candidates. Visit
https://invivyd.com/ to learn more.
Trademarks are the property of their respective owners.
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,”
“estimates,” “intends,” “potential,” “predicts,” “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 company’s goal of near-term profitability; the
company’s expectations regarding anticipated net product revenue
growth and continued reduction of manufacturing expenses; the
future of the COVID-19 landscape and potential impact of COVID-19
on certain patients; the company’s plans to raise further awareness
of PEMGARDA in the healthcare community; the company’s ongoing
research and development activities, as well as future potential
research and development efforts; the ongoing in vitro neutralizing
activity of PEMGARDA and VYD2311 against dominant SARS-CoV-2
variants; the potential of PEMGARDA as a mAb for pre-exposure
prophylaxis (prevention) of COVID-19 in certain adults and
adolescents who have moderate-to-severe immune compromise; the
company’s expectations regarding engagement with the FDA; the
potential of VYD2311 as a novel mAb candidate that may be able to
deliver clinically meaningful titer levels through more
patient-friendly means; the company’s devotion to delivering
protection from serious viral infectious diseases, beginning with
SARS-CoV-2; 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: uncertainties regarding the company’s expectations,
projections and estimates regarding future costs and expenses,
future revenue, capital requirements, and the availability of and
the need for additional financing; whether the company’s cash and
cash equivalents are sufficient to support its operating plan for
as long as anticipated; uncertainties regarding market acceptance,
payor coverage and reimbursement, or future revenue generated by
PEMGARDA; how long the EUA granted by the FDA for PEMGARDA will
remain in effect and whether the EUA is revised or revoked by the
FDA; the ability to maintain a continued acceptable safety,
tolerability and efficacy profile of any product candidate
following regulatory authorization or approval; the success of the
company’s in-house sales force, and company’s ability to maintain
and expand sales, marketing and distribution capabilities to
successfully commercialize PEMGARDA; changes in expected or
existing competition; changes in the regulatory environment; the
outcome of the company’s engagement with regulators; uncertainties
related to the regulatory authorization or approval process, and
available development and regulatory pathways; the timing, progress
and results of the company’s discovery, preclinical and clinical
development activities; unexpected safety or efficacy data observed
during preclinical studies or clinical trials; the predictability
of clinical success of the company’s product candidates based on
neutralizing activity in nonclinical studies; the risk that results
of nonclinical studies or clinical trials may not be predictive of
future results, and interim data are subject to further analysis;
potential variability in neutralizing activity of product
candidates tested in different assays, such as pseudovirus assays
and authentic assays; variability of results in models and methods
used to predict activity against SARS-CoV-2 variants; whether the
epitope that pemivibart and VYD2311 targets remains structurally
intact; whether the company’s product candidates are able to
demonstrate and sustain neutralizing activity against major
SARS-CoV-2 variants, particularly in the face of viral evolution;
whether the company’s integrated technology platform is able to
produce mAbs with broad and durable viral protection along with
improved drug properties; the company’s reliance on third parties;
clinical trial site activation or enrollment rates; the
complexities of manufacturing mAb therapies; macroeconomic and
political uncertainties; the company’s ability to continue as a
going concern; 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, 2023 and the company’s Quarterly Report on
Form 10-Q for the quarter ended September 30, 2024, each 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:
Media Relations(781)
208-1747media@invivyd.com
Investor Relations(781)
208-1747investors@invivyd.com
|
INVIVYD, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS (UNAUDITED)(In
thousands, except share and per share amounts) |
|
|
|
December 31,2024 |
|
|
December 31,2023 |
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
69,349 |
|
|
$ |
200,641 |
|
Accounts receivable |
|
|
10,906 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
20,426 |
|
|
|
24,240 |
|
Total current assets |
|
|
100,681 |
|
|
|
224,881 |
|
Inventory, net |
|
|
25,907 |
|
|
|
— |
|
Property
and equipment, net |
|
|
1,508 |
|
|
|
1,896 |
|
Operating lease right-of-use assets |
|
|
1,385 |
|
|
|
2,229 |
|
Other
non-current assets |
|
|
34 |
|
|
|
175 |
|
Total assets |
|
$ |
129,515 |
|
|
$ |
229,181 |
|
Liabilities, Preferred Stock and Stockholders’
Equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
10,448 |
|
|
$ |
7,953 |
|
Accrued expenses(1) |
|
|
50,197 |
|
|
|
40,860 |
|
Operating lease liabilities, current |
|
|
1,304 |
|
|
|
1,443 |
|
Other current liability |
|
|
27 |
|
|
|
35 |
|
Total current liabilities |
|
|
61,976 |
|
|
|
50,291 |
|
Operating lease liabilities, non-current |
|
|
— |
|
|
722 |
|
Other
non-current liability(2) |
|
|
— |
|
|
700 |
|
Total liabilities |
|
|
61,976 |
|
|
|
51,713 |
|
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 December
31, 2024 and December 31, 2023 |
|
|
— |
|
|
|
— |
|
Common
stock, $0.0001 par value; 1,000,000,000 shares authorized,
119,835,162 shares issued and outstanding at December 31, 2024;
110,160,684 shares issued and outstanding at December 31, 2023 |
|
|
12 |
|
|
|
11 |
|
Additional paid-in capital |
|
|
969,526 |
|
|
|
909,539 |
|
Accumulated other comprehensive loss |
|
|
(5 |
) |
|
|
(13 |
) |
Accumulated deficit |
|
|
(901,994 |
) |
|
|
(732,069 |
) |
Total stockholders’ equity |
|
|
67,539 |
|
|
|
177,468 |
|
Total liabilities, preferred stock and stockholders’ equity |
|
$ |
129,515 |
|
|
$ |
229,181 |
|
(1) |
Includes related-party amounts of $1,274 and $0 for the years ended
December 31, 2024 and 2023, respectively. |
(2) |
Includes related-party amounts of $0 and $700 for the years ended
December 31, 2024 and 2023, respectively. |
|
INVIVYD, INC. CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)(In thousands, except share and
per share amounts) |
|
|
|
|
|
Year Ended December 31, |
|
|
Year Ended December 31, |
|
|
|
|
|
2024 |
|
|
2023 |
|
Revenue: |
|
|
|
|
|
|
|
|
Product revenue, net |
|
|
|
$ |
25,384 |
|
|
$ |
— |
|
Total revenue |
|
|
|
|
25,384 |
|
|
|
— |
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
Cost of product revenue(1) |
|
|
|
|
1,618 |
|
|
|
— |
|
Research and development (2) |
|
|
|
|
137,254 |
|
|
|
158,658 |
|
Acquired in-process research and development (3) |
|
|
|
|
— |
|
|
|
4,975 |
|
Selling, general and administrative |
|
|
|
|
63,388 |
|
|
|
49,125 |
|
Total operating costs and expenses |
|
|
|
|
202,260 |
|
|
|
212,758 |
|
Loss
from operations |
|
|
|
|
(176,876 |
) |
|
|
(212,758 |
) |
Other
income: |
|
|
|
|
|
|
|
|
Other income, net |
|
|
|
|
6,951 |
|
|
|
14,115 |
|
Total other income, net |
|
|
|
|
6,951 |
|
|
|
14,115 |
|
Net
loss |
|
|
|
|
(169,925 |
) |
|
|
(198,643 |
) |
Other
comprehensive income (loss) |
|
|
|
|
|
|
|
|
Unrealized gain on available-for-sale securities, net of tax |
|
|
|
|
8 |
|
|
|
259 |
|
Comprehensive loss |
|
|
|
$ |
(169,917 |
) |
|
$ |
(198,384 |
) |
Net loss
per share attributable to common stockholders, basic and
diluted |
|
|
|
$ |
(1.43 |
) |
|
$ |
(1.81 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
|
|
118,555,073 |
|
|
|
109,526,053 |
|
(1) |
Includes related-party amounts of $1,027 and $0 for the years ended
December 31, 2024 and 2023, respectively. |
(2) |
Includes related-party amounts of $4,546 and $8,418 for the years
ended December 31, 2024 and 2023, respectively. |
(3) |
Includes related-party amounts of $0 and $4,975 for the years ended
December 31, 2024 and 2023, respectively. |
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