Revelation Biosciences Inc. (Revelation), a clinical-stage life
sciences company that is focused on the development of
immunologic‑based therapies for the prevention and treatment of
disease, announced today it has received approval from the Federal
Agency for Medicines and Health Products (FAMHP) and the local
Committee of Medical Ethics in Belgium to conduct a Phase 2b
influenza viral challenge study. The Phase 2b, randomized,
double-blind, influenza viral challenge study (RVL-VRL01) is
planned in healthy volunteers. This viral challenge investigation
will evaluate the potential efficacy of a single- and repeat-dose
(twice) of REVTx-99 prophylaxis versus placebo on viral load and
clinical illness influenza symptoms (Influenza Patient-reported
Outcome (FLU-PRO) questionnaire). The study will include up to 60
participants and is expected to begin enrolling participants in the
first quarter of 2022 with top-line data in the second quarter of
2022. Success in this type of viral challenge study may be
predictive of future activity in later stage real-world field
studies.
“We have spent far too long accepting the deadly
and economic impacts of respiratory viruses, including influenza,
as something we have to live with,” said James Rolke, Chief
Executive Officer of Revelation Biosciences. “COVID-19 has
highlighted the global need for new solutions that address
respiratory viruses and their many inevitable variants. The results
of this viral challenge study are an important step in the
development of REVTx-99 for the potential prevention and treatment
of respiratory viral infections, like influenza and COVID-19.”
An initial Phase 1 clinical study (RVL-NHV01) was conducted in
healthy volunteers to evaluate the safety and tolerability of
REVTx-99 as well as its effect on levels of intranasal cytokines.
The study consisted of 5 single ascending cohorts oof single
escalating doses and repeat doses of REVTx-99. In addition, in this
study, 40 healthy participants were dosed in five ascending single
dose cohorts and 8 healthy participants were dosed at the highest
dose daily for 5 days. REVTx-99 was well tolerated with no
significant or serious adverse events. REVTx-99 also showed a dose
dependent increase in intranasal cytokines including a key cytokine
of interest, IP-10.
For more information on Revelation, please visit
www.RevBiosciences.com.
About REVTx-99
REVTx-99 is a proprietary intranasal drop
formulation in development for the prevention or treatment of
respiratory viral infection and is broadly applicable to most
infectious viruses including Influenza A, Influenza B,
parainfluenza, rhinovirus, respiratory syncytial virus (RSV),
SARS-CoV-2 and its variants. Influenza and SARS-CoV-2 have viral
proteins that have been shown to block the production of
interferons, a key part of the innate immune response to viral
infection, resulting in worsened clinical outcomes. REVTx-99 acts
by stimulating the innate immune system at the site of infection
via an alternative pathway (TLR4) to produce protective cytokines
including Type I and Type II interferons.
The innate immune system is the first line of
defense against invading pathogens such as bacteria and viruses.
Toll-like receptors (TLRs) are associated with sentinel cells (e.g.
macrophages, dendritic cells) and serve a vital role in the innate
immune response. TLRs recognize repeated molecular patterns
associated with pathogens (PAMPS). When a pathogen invades a
person, TLRs recognize PAMPS as foreign and activate the innate
immune response, inducing the production of numerous cytokines to
combat the invading pathogen and stimulate the adaptive immune
response.
Other indications for REVTx-99 are planned
including allergic rhinitis and chronic nasal congestion.
About Revelation Biosciences Inc.
Revelation Biosciences, Inc. is a clinical stage
life sciences company focused on the development of
immunologic-based therapies for the prevention and treatment of
disease. Revelation has several product candidates in development.
REVTx-99, the lead therapeutic candidate, is an intranasal
immunomodulator to prevent or treat infections caused by various
respiratory viruses such as SARS-CoV-2 including its variants,
influenza A and B, parainfluenza, rhinovirus, and RSV. REVTx-200 is
an intranasal immunomodulator adjunct to be used in combination
with an intramuscular vaccination for more complete immunity.
REVTx-200 is based on the same technology used in REVTx-99. In
addition to Revelation’s therapeutic pipeline, Revelation is also
developing REVDx-501, a rapid home use diagnostic that can be used
to detect any respiratory viral infection, regardless of virus type
or strain, without the need for specialized instrumentation.
Revelation recently announced that it has
entered into a definitive merger agreement (Merger Agreement) with
Petra Acquisition, Inc. (NASDAQ: PAICU, PAIC, & PAICW), a
special purpose acquisition company, for a business combination
that will result in Revelation becoming a publicly traded company.
The merger is expected to close in Q4 2021. After the close of the
merger the combined company will be listed on NASDAQ under the
ticker symbol “REVB.”
For more information on Revelation, please visit
www.RevBiosciences.com.
About Petra Acquisition,
Inc.
Petra Acquisition, Inc. (Nasdaq: PAIC) is a
blank check company organized for the purpose of effecting a
merger, share exchange, asset acquisition, stock purchase,
recapitalization, reorganization or other similar business
combination with one or more businesses or entities, with an
initial focus on target businesses in the healthcare or a
healthcare-related industry.
Forward-Looking Statements
This press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended, including statements regarding the
anticipated benefits of the transaction, the anticipated timing of
the transaction, the future business and financial condition of the
company post-closing and expected financial impacts of the
transaction, the satisfaction of closing conditions to the
transaction, the level of redemptions of Petra’s public
stockholders; the market opportunities for Revelation’s product
candidates; and the potential for regulatory approval for
Revelation’s product candidates. These forward-looking statements
are generally identified by the words "anticipate", "believe",
"expect", "estimate", "plan", "outlook", and "project" and other
similar expressions. Forward-looking statements are statements that
are not historical facts. We caution investors that forward-looking
statements are based on management’s expectations and are subject
to various risks and uncertainties. As a result, caution must be
exercised in relying on forward-looking statements, which speak
only as of the date they were made. The following factors, among
others, could cause actual results to differ materially from those
described in these forward-looking statements: risks relating to
the successful completion of RVL-VRL01 clinical study; the risk
that we may not fully enroll our RVL-VRL01 clinical study or
enrollment will take longer than expected; risks relating to the
occurrence of adverse safety events and/or unexpected concerns that
may arise from additional data or analysis from our RVL-VRL01
clinical study; the risk that the results from RVL-VRL01 may differ
significantly from the results of our Phase 1 clinical study; the
occurrence of any event, change or other circumstances that could
give rise to an amendment or termination of the Merger Agreement
and the proposed transaction contemplated thereby; the inability to
complete the transactions contemplated by the Merger Agreement due
to the failure to obtain approval of the stockholders of Petra or
Revelation or other conditions to closing in the Merger Agreement;
the inability to project with any certainty the amount of cash
proceeds remaining in the Petra trust account at the closing of the
transaction; the uncertainty relative to the cash made available to
Revelation at the closing should any material redemption requests
be made by the Petra stockholders (since the sources of cash
projected in this press release assume that no redemptions will be
requested by Petra stockholders); the inability of the company
post-closing to obtain or maintain the listing of its securities on
Nasdaq following the business combination; the amount of costs
related to the business combination; Revelation’s ability to yield
sufficient cash proceeds from the transaction to support its
short-term operations and research and development efforts since
the Merger Agreement requires no minimum level of funding in the
trust fund to close the transaction; the outcome of any legal
proceedings that may be instituted against the parties following
the announcement of the business combination; changes in applicable
laws or regulations; the ability of Revelation to meet its
post-closing financial and strategic goals, due to, among other
things, competition; the ability of the company post-closing to
grow and manage growth profitability and retain its key employees;
the possibility that the company post-closing may be adversely
affected by other economic, business, and/or competitive factors;
risks relating to the successful development of Revelation’s
product candidates; the clinical utility of an increase in
intranasal IP-10 levels as a biomarker of viral infections; the
ability to complete planned clinical studies of REVTx-99; expected
initiation of the clinical studies, the timing of clinical data;
the outcome of the clinical data, including whether the results of
such study is positive or whether it can be replicated; the outcome
of data collected, including whether the results of such data
and/or correlation can be replicated; the timing, costs, conduct
and outcome of our other clinical studies; the anticipated
treatment of future clinical data by the FDA, the EMA or other
regulatory authorities, including whether such data will be
sufficient for approval; the success of future development
activities for REVTx-99 and expanded indications, REVTx-200,
REVDx-501, or any other product candidates; potential indications
for which product candidates may be developed; the potential impact
that COVID-19 may have on Revelation’s suppliers, vendors,
regulatory agencies, employees and the global economy as a whole;
the expected duration over which Revelation’s balances will fund
its operations; and other risks and uncertainties described herein,
as well as those risks and uncertainties discussed from time to
time in other reports and other public filings with the SEC by
Petra.
No Offer or Solicitation
This press release shall not constitute an offer
to sell or the solicitation of an offer to buy any securities, nor
shall there be any sale of securities in any states or
jurisdictions in which such offer, solicitation, or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering of securities
shall be made except by means of a prospectus meeting the
requirements of Section 10 of the Securities Act, or an exemption
therefrom.
Important Information and Where to Find
It
In connection with the proposed Business
Combination described herein, Petra has filed relevant materials
with the SEC, including a Registration Statement on Form S-4, that
includes a preliminary proxy statement/prospectus, and when
available, will file a definitive proxy statement and final
prospectus. Promptly after filing its definitive proxy statement
with the SEC, Petra will mail the definitive proxy statement and a
proxy card to each stockholder entitled to vote at the Special
Meeting relating to the transaction. INVESTORS AND STOCKHOLDERS OF
PETRA ARE URGED TO READ THESE MATERIALS (INCLUDING ANY AMENDMENTS
OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS IN
CONNECTION WITH THE TRANSACTION THAT PETRA WILL FILE WITH THE SEC
WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION ABOUT PETRA, REVELATION AND THE BUSINESS COMBINATION.
The definitive proxy statement, the preliminary proxy statement and
other relevant materials in connection with the transaction (when
they become available), and any other documents filed by Petra with
the SEC, may be obtained free of charge at the SEC’s website
(www.sec.gov).
Participants in the
Solicitation
Petra and its directors and executive officers
may be deemed participants in the solicitation of proxies from
Petra’s stockholders with respect to the Business Combination. A
list of the names of those directors and executive officers and a
description of their interests in Petra will be included in the
proxy statement for the proposed Business Combination and be
available at www.sec.gov. Additional information regarding the
interests of such participants will be contained in the proxy
statement for the proposed Business Combination when available.
Information about Petra’s directors and executive officers and
their ownership of Petra common stock is set forth in Petra’s
prospectus, dated October 7, 2020, as modified or supplemented by
any Form 3 or Form 4 filed with the SEC since the date of such
filing. Other information regarding the interests of the
participants in the proxy solicitation will be included in the
proxy statement pertaining to the proposed business combination
when it becomes available. These documents can be obtained free of
charge at the SEC’s website (www.sec.gov).
Revelation and its directors and executive officers may also be
deemed to be participants in the solicitation of proxies from the
stockholders of Petra in connection with the proposed Business
Combination. A list of the names of such directors and executive
officers and information regarding their interests in the proposed
Business Combination will be included in the proxy statement for
the proposed Business Combination.Company
Contacts
Sandra VedrickVice President, Investor Relations & Human
ResourcesRevelation Biosciences Inc. Email:
svedrick@revbiosciences.com
and
Chester Zygmont, IIIChief Financial OfficerRevelation
Biosciences Inc. Email: czygmont@revbiosciences.com
Media contact: Kristin Faulder kristin@heurisay.com
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