Proposed merger heads to shareholder vote on
December 23rd as ongoing Phase I trial shows potential for
unboosted oral regimen
In advance of the shareholder vote for the business combination
between FS Development Corp. II (NASDAQ: FSII) and Pardes
Biosciences, Inc. (“Pardes”), the CEOs of both companies are
sharing their thoughts on the COVID-19 public health emergency and
how they expect the combined company to play an important role in
addressing one of the biggest health crises of our time.
“We believe that direct-acting antivirals against coronavirus
that are taken orally – such as our PBI-0451 – will become
increasingly important in a world where SARS-CoV-2 may become
endemic. This eventuality appears more likely with the spread of
new highly transmissible variants, such as Delta and Omicron,” said
Uri Lopatin, M.D., Chief Executive Officer of Pardes Biosciences.
“At Pardes, our aspiration is to be a leader in the development of
potential therapies against these types of viruses, starting with
PBI-0451 which is in Phase I clinical studies.”
PBI-0451 is a type of antiviral drug called a protease
inhibitor. This class of drug has been successfully deployed
against diseases such as HIV and hepatitis C. More recently, Pfizer
Inc. (“Pfizer”) has helped to demonstrate the potential of their
protease inhibitor (when used together with a second drug called
ritonavir) to be a potentially important new tool to address the
COVID-19 pandemic. This class of drugs has the potential, if taken
upon exposure or as treatment when symptoms arise, to lower the
risk of hospitalization and death, particularly among individuals
who are at higher risk for severe infection, such as those with
other medical conditions who are vaccinated but with a poor or
diminished immune response or are unvaccinated. The Pardes team
believes that oral protease inhibitors are potentially easier to
make, transport, and administer than injectable treatments such as
antibodies and vaccines, so their manufacture and distribution to
patients may face fewer barriers.
Pardes is currently dosing healthy volunteers in a Phase I
clinical study of its protease inhibitor, PBI-0451, that is
exploring potential dosing levels, intervals and regimens. Topline
results are expected to be reported in Q1 2022.
“As we dose escalate, the tolerability and pharmacokinetics to
date continue to support the potential for dosing of PBI-0451 as a
single agent, without the use of a second ‘boosting’ agent to help
increase its levels in the body such as ritonavir, which is used in
conjunction with Pfizer’s protease inhibitor (PAXLOVID™). Assuming
data from our Phase 1 clinical study continues to support
advancement of PBI-0451, we plan to evaluate our tablet formulation
in Q1 2022 and - pending regulatory approval - to initiate a Phase
2/3 registrational study in mid 2022,” continued Dr. Lopatin. “We
believe that the potential for a simple anti-viral treatment for
patients that can be initiated immediately upon diagnosis will be
important - especially for those patients with the greatest need,
such as the elderly and immunocompromised who often take other
medicines for their medical conditions that may be incompatible
with drugs like ritonavir.”
“We believe the coronaviral main protease is a key target for
SARS-CoV-2 antiviral development as inhibitors of this target are
anticipated to have activity against all currently known variants,”
added Jim Tananbaum, M.D., Chief Executive Officer, President and
Director of FSII. “Pfizer’s PAXLOVID™ (nirmatrelvir + ritonavir), a
boosted protease inhibitor, has demonstrated the impressive
potential of this class of drug in humans. We look forward to a
world where the COVID pandemic is defeated by a combination of
outbreak surveillance, vaccines, and oral antivirals.”
The proposed merger heads to a vote of FSII’s stockholders on
December 23, 2021.
About Pardes Biosciences, Inc.
Pardes Biosciences is a clinical-stage biopharmaceutical
company created by and for this moment to help solve pandemic-sized
problems, starting with COVID-19. We are applying modern
reversible-covalent chemistry as a starting point to discover and
develop novel oral drug candidates while reimagining the patient
journey to access these medicines. The company’s lead product
candidate, PBI-0451, is being developed as a direct-acting, oral
antiviral drug to treat and prevent SARS-CoV-2 infections, the
virus responsible for COVID-19. Pardes Biosciences is committed to
innovating every aspect of how we work, including the flexibility
of remote working and regional hubs. We are on a mission to stop a
pandemic and start a movement so patients everywhere can get well
sooner. For more information, please visit www.pardesbio.com.
About PBI-0451
PBI-0451 is an investigational orally bioavailable direct-acting
antiviral inhibitor of the coronaviral “main protease” (Mpro), an
essential protein required for the replication of all known
coronaviruses, including the novel SARS-CoV-2 virus that causes
COVID-19. This protease is highly similar across all coronaviruses,
including known and emerging coronavirus variants. PBI-0451 is
being developed as a direct-acting, oral antiviral drug candidate
for the treatment and prevention of SARS-CoV-2 infection and
associated diseases.
About FS Development Corp. II (FSII)
FS Development Corp. II, sponsored by Foresite Capital, is a
blank check company formed for the purpose of effecting a business
combination with one or more businesses in the biotechnology
sector. The company is led by Jim Tananbaum, M.D., the CEO of
Foresite Capital, an investment firm funding visionary healthcare
entrepreneurs with approximately $4 billion in assets under
management. The firm is headquartered in the San Francisco Bay
Area.
Important Information About the Business Combination and
Where to Find It
In connection with the merger agreement, dated June 29, 2021,
entered into by and among FS Development Corp. II (the
“Company”), Orchard Merger Sub, Inc., Pardes Biosciences,
Inc. (“Pardes”) and Shareholder Representative Services LLC,
relating to a business combination between the Company and Pardes
(the “Business Combination”), the Company has filed with the
U.S. Securities and Exchange Commission (the “SEC”) a
registration statement on Form S-4 (File No. 333-258442) (as
amended, the “Registration Statement”), which includes a
full description of the terms of the Business Combination and
includes a prospectus with respect to the combined company’s
securities to be issued in connection with the Business Combination
and a proxy statement with respect to the shareholder meeting of
the Company to vote on the Business Combination. The Company
urges its investors, stockholders and other interested persons to
read the definite proxy statement/prospectus included in the
Registration Statement, as well as other documents filed with the
SEC, because these documents contain important information about
the Company, Pardes and the Business Combination. The
Registration Statement was declared effective by the SEC on
December 1, 2021 and the definitive proxy statement/prospectus and
other relevant documents have been mailed to the Company’s
stockholders of record as of the close of business on November 18,
2021. Stockholders may also obtain a copy of the definitive proxy
statement/prospectus, and other documents filed with the SEC,
without charge, by directing a request to: FS Development Corp. II,
Attn: Secretary, 900 Larkspur Landing Circle, Suite 150, Larkspur,
California 94939. The definitive proxy statement/prospectus can
also be obtained, without charge, at the SEC’s website at
www.sec.gov.
Participants in the Solicitation
The Company and Pardes and their respective directors and
executive officers may be considered participants in the
solicitation of proxies with respect to the Business Combination
under the rules of the SEC. A list of the names of those directors
and executive officers and a description of their interests in the
Company is contained in the definitive proxy statement/prospectus
included in the Registration Statement and is available free of
charge at the SEC’s website at www.sec.gov or by directing a
request to: FS Development Corp II., Attn: Secretary, 900 Larkspur
Landing Circle, Suite 150, Larkspur, California 94939.
Forward-Looking Statements
This press release of the Company dated December 21, 2021 (this
“Press Release”) contains forward-looking statements that
are based on beliefs and assumptions and on information currently
available. In some cases, you can identify forward-looking
statements by the following words: “may,” “will,” “could,” “would,”
“should,” “expect,” “intend,” “plan,” “anticipate,” “believe,”
“estimate,” “predict,” “project,” “potential,” “continue,”
“ongoing” or the negative of these terms or other comparable
terminology, although not all forward-looking statements contain
these words. These statements involve risks, uncertainties and
other factors that may cause actual results, levels of activity,
performance or achievements to be materially different from the
information expressed or implied by these forward-looking
statements. Although we believe that we have a reasonable basis for
each forward-looking statement contained in this Press Release, we
caution you that these statements are based on a combination of
facts and factors currently known by us and our projections of the
future, about which we cannot be certain. Forward-looking
statements in this Press Release include, but are not limited to,
statements regarding the proposed Business Combination, including
the timing and structure of the Business Combination, the proceeds
of the Business combination, the initial market capitalization of
the combined company and the benefits of the Business Combination,
as well as statements about the potential attributes and benefits
of Pardes’ product candidates, including the potential for dosing
of PBI-0451 as a single agent without a requirement for the
addition of a metabolic boosting agent such as ritonavir, and the
format and timing of Pardes’ product development activities and
clinical trials, including development plans for registrational
trials and regulatory interactions. We cannot assure you that the
forward-looking statements in this Press Release will prove to be
accurate. These forward-looking statements are subject to a number
of significant risks and uncertainties that could cause actual
results to differ materially from expected results, including,
among others, the ability to complete the Business Combination due
to the failure to obtain approval from the Company’s shareholders
or satisfy other closing conditions in the merger agreement, the
occurrence of any event that could give rise to the termination of
the merger agreement, the ability to recognize the anticipated
benefits of the Business Combination, the outcome of any legal
proceedings that may be instituted against the Company or Pardes,
development of competing therapeutic treatments for COVID-19 on
Pardes’ business and/or the ability of the parties to complete the
Business Combination, the ability to obtain or maintain the listing
of the Company’s common stock on Nasdaq following the proposed
Business Combination, costs related to the proposed Business
Combination, changes in applicable laws or regulations, the
possibility that the Company or Pardes may be adversely affected by
other economic, business, and/or competitive factors, the risks
inherent in drug discovery and development, including design,
conduct, timing and results of clinical trials and interactions
with regulatory authorities and other risks and uncertainties,
including those included under the header “Risk Factors” in the
Registration Statement and those included under the header “Risk
Factors” in the final prospectus of the Company related to its
initial public offering. Most of these factors are outside the
Company’s and Pardes’ control and are difficult to predict.
Furthermore, if the forward-looking statements prove to be
inaccurate, the inaccuracy may be material. In light of the
significant uncertainties in these forward-looking statements, you
should not regard these statements as a representation or warranty
by us or any other person that we will achieve our objectives and
plans in any specified time frame, or at all. The forward-looking
statements in this Press Release represent our views as of the date
of this Press Release. We anticipate that subsequent events and
developments will cause our views to change. However, while we may
elect to update these forward-looking statements at some point in
the future, we have no current intention of doing so except to the
extent required by applicable law. You should, therefore, not rely
on these forward-looking statements as representing our views as of
any date subsequent to the date of this Press Release.
No Offer or Solicitation
This Press Release is not a proxy statement or solicitation of a
proxy, consent or authorization with respect to any securities or
in respect of the Business Combination and shall not constitute an
offer to sell or a solicitation of an offer to buy any securities,
nor shall there be any sale of securities in any state or
jurisdiction in which such offer, solicitation, or sale would be
unlawful prior to registration or qualification under the
securities laws of such state or jurisdiction. No offer of
securities shall be made except by means of a prospectus meeting
the requirements of the Securities Act of 1933, as amended.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211221005034/en/
Pardes Investor Contacts: Laurence Watts Gilmartin Group
(619) 916-7620 laurence@gilmartinir.com Stephen Jasper Gilmartin
Group (858) 525-2047 stephen@gilmartinir.com Pardes Media
Contact: Sophia Patel Pardes Biosciences (415) 306-1776
media@pardesbio.com FSII Contact: Foresite Capital Cindy
Mesaros 415-413-7627 press@foresitecapital.com
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