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 been granted ethics committee
approval (Bellberry Limited Human Research Ethics Committee [HREC])
in Australia to conduct a Phase 1b allergen challenge clinical
study (RVL-CLR01) to evaluate the potential utility of REVTx-99 for
treating patients with allergic rhinitis and patients with chronic
nasal congestion.
“REVTx-99 is being developed for preventing and
treating respiratory viral infections, like influenza and COVID-19.
However, based on our phase 1 biomarker data, we believe REVTx-99
may also prove successful in reducing allergy symptoms, including
chronic nasal congestion,” said James Rolke, Chief Executive
Officer of Revelation Biosciences.
In the US, approximately 8% of adults and 7% of
children have allergies that cause symptoms of allergic rhinitis,
also called hay fever, based on current CDC data. Hay fever
symptoms include itchy eyes, itchy nose, sneezing, runny nose and
nasal congestion caused by seasonal, perennial, or even unknown
sources of allergies. In some people the allergies can trigger long
term allergen-related chronic nasal congestion (nasal congestion
lasting for twelve or more weeks). Chronic nasal congestion affects
approximately 12% of the US adult population, equating to at least
29 million people in the US having nasal congestion for three or
more months out of the year.
The Phase 1b, randomized, double-blind,
placebo-controlled, crossover design study will enroll up to 28
participants. The primary endpoint is to evaluate the effects of
REVTx-99 versus placebo on safety and tolerability. Key secondary
endpoints include allergy symptoms and peak nasal inspiratory flow
elicited by nasal allergen challenge. The study will have two
cohorts, each cohort will receive an allergen challenge
administered either before (prophylactic) study drug administration
or after (treatment) study drug administration, then after a
washout period the cohorts will crossover to either after or before
(i.e. before->after, after->before). Revelation expects
enrollment of RVL‑CLR01 to begin during the fourth quarter of 2021
with topline data early in the first quarter of 2022.
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. REVTx-99 is also being developed for
other indications such as: allergic rhinitis and chronic nasal
congestion. 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. 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. Through stimulation of TLR4, locally administered
REVTx-99 induces the upregulation of localized cytokines and
chemokines, which may directly compete for binding to eotaxin via
the CCR3 receptor, preventing eotaxin from recruiting
eosinophils, thereby reducing recruitment of Th2 cells, and
attenuating the allergic response.
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-99 is
also being developed for other indications such as: allergic
rhinitis and chronic nasal congestion. 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
(Business Combination). 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: PAICU, PAIC,
& PAICW) 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-CLR01 clinical study; the risk
that we may not fully enroll our RVL-CLR01clinical 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 data or analysis from our RVL-CLR01 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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