Revelation Biosciences Inc. Announces Data Demonstrating REVTx-99
In Vitro Anti-Viral Activity Against SARS-CoV-2; Commencement of Trading
as a Public Company
-A greater than 50% reduction in SARS-CoV-2 Delta viral load was observed-
-REVTx-99 was tested prior to infection in multiple standard in vitro anti-viral activity assay systems-
-Previously announced SPAC merger closes, Revelation Biosciences, Inc. publicly listed on the NASDAQ under symbol REVB-
-Revelation to host conference call and webcast at 4:30 p.m. Eastern Time on January 11, 2022. The conference call can be accessed by dialing 877-815-0146 for domestic callers and 631-625-3219 for international callers. Please provide the operator with the passcode 1847899 to join the conference call or click here for the webcast. An archive of the conference call and webcast will be available on Revelation’s website for 30 days following the call.-
San Diego, CA – January 11, 2022 – Revelation Biosciences Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on the development of immunologic‑based therapies for the prevention and treatment of disease, today announced it has observed significant decrease in viral load with prophylactic treatment of REVTx-99 in three independent in vitro single cell-based assay models of SARS-CoV-2 infection.
In addition, the company announced that they have completed their business combination with Petra Acquisition, Inc. and will trade under “REVB” and “REVBW” beginning today, January 11, 2022.
How REVTx-99 Works
REVTx-99 binds to toll-like receptor 4 (TLR4), stimulating and inducing host-directed factors that augment the production of protective cytokines including interferons and interferon-related proteins which contributes to the establishment of an anti-viral state regardless of virus type, strain, or variant.
The Studies and Findings
REVTx-99 was assessed for prophylactic anti-viral activity against SARS-CoV-2 Delta infection in three separate cell lines, each expressing sufficient levels of ACEII and TLR4, receptors required to sufficiently demonstrate viral infection as well as REVTx-99 activity, respectively.
• Human primary bronchial/tracheal cells were expanded and treated with 250 nanograms per mL (ng/mL) REVTx-99 one hour prior to infection. SARS-CoV-2 viral spike protein was measured using a cell-based ELISA. Viral load was reduced by more than 50% when compared to the non-treated viral assay control.
• Human alveolar epithelial cells (A549, Adenocarcinomic) were treated with 250 ng/mL REVTx-99 24 hours prior to infection. SARS-CoV-2 viral load was measured using RT-qPCR. Viral load was reduced more than 50% when compared to the non-treated viral assay control.
• Human lung epithelial cells (Calu-3, Adenocarcinomic) were treated with REVTx-99 one hour prior to infection. SARS-CoV-2 was measured using the plaque formation assay, which detected SARS-CoV-2 plaque forming units (PFUs). Treatment with REVTx-99 at 250ng/mL and 1000ng/mL reduced the number of PFUs by 19%, and 29%, respectively, compared to the non-treated viral control.
These studies were conducted on behalf of Revelation by a third-party contract research laboratory specializing in viral activity assays.
Revelation is continuing to develop and optimize in vitro and in vivo models to define TLR4 stimulation in response to REVTx-99, and identify a dose range for optimal anti-viral efficacy against SARS-CoV-2, additional variants such as Omicron, and other viruses including rhinovirus, respiratory syncytial virus, and influenza. Additional in vitro anti-viral dose response results for REVTx-99 will be used to inform the design for our planned preclinical studies.
"These results, along with our early clinical study results, (Revelation study REV-NHV01), suggest REVTx-99 creates an anti-viral state in relevant cell types and encourage us to continue our work to demonstrate the anti-viral potential for REVTx-99, especially considering the continuous introduction of new variants, such as Omicron”, said James Rolke, Chief Executive Officer of Revelation. “With new, more infective SARS-CoV-2 variants emerging, and the continued impact of COVID-19 on the daily lives of people around the world, we remain focused on rapidly advancing this urgently needed protective therapy to fill the current unmet need."
During the 2019-2020 season, the CDC estimates that influenza was associated with 38 million illnesses, 18 million medical visits, 405,000 hospitalizations, and 22,000 deaths. Globally, COVID-19 is responsible for more than 5 million deaths, with thousands of people dying every day.
Revelation Biosciences, Inc. Publicly Listed on the NASDAQ
Revelation has completed its previously-announced business combination with Petra Acquisition, Inc., a special purpose acquisition company. The transaction was approved at a special meeting of the Petra stockholders on January 6, 2022 following unanimous approval by Revelation stockholders. The common stock of the combined company will trade under “REVB”, “REVBW”, and “REVBU” beginning today, January 11, 2022.
For more information on Revelation, please visit www.RevBiosciences.com.
Investor Conference Call Information
Revelation will host investor conference call and webcast on January 11, 2022 at 4:30 p.m. Eastern Time. The conference call can be accessed by dialing 877-815-0146 for domestic callers and 631-625-3219 for international callers. Please provide the operator with the passcode 1847899 to join the conference call or click here for the webcast. An archive of the conference call and webcast will be available on Revelation’s website for 30 days following the call
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. The active ingredient in REVTx-99 stimulates the nasal (mucosal) innate immune system via interaction with toll-like receptor 4 (TLR4) to produce protective cytokines including interferons and interferon-related proteins. These protective cytokines work in concert to blunt the ability of an invading virus to proliferate and survive. Phase 1 data showed REVTx-99 to be well-tolerated and to significantly increase intranasal protective cytokines.
In addition, to viral infection, REVTx-99 is also being developed for management of allergic rhinitis symptoms and chronic nasal congestion without polyps. REVTx-99 upregulates a protein which competes for the native eotaxin receptor, CCR3, 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.
For more information on Revelation, please visit www.RevBiosciences.com.
Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions. We caution investors that forward-looking statements are based on management’s expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such 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: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth profitability and retain its key employees; the possibility that the Revelation 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 cytokine levels as a biomarker of viral infections; the ability to complete planned clinical studies of REVTx-99; risks relating to the successful completion of RVL-CLR01 and RVL-VRL01 clinical studies; the risk that we may not fully enroll our clinical studies 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 clinical studies; changes in applicable laws or regulations; 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 ability of Revelation to maintain the listing of its securities on NASDAQ; 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 Revelation.
Company Contacts
Sandra Vedrick
Vice President, Investor Relations & Human Resources
Revelation Biosciences Inc.
Email: svedrick@revbiosciences.com
and
Chester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.com
Media contact:
Kristin Faulder
kristin@heurisay.com