Revelation Biosciences, Inc 8-K, filed Aug 31, 2021
Revelation Biosciences, Inc. (REVB)
About this 8-K
Revelation Biosciences, Inc filed this 8-K on August 31, 2021.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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Item 7.01 Regulation FD Disclosure
On August 30,2021, Petra Acquisition Inc. (“PAI”) and Revelation Biosciences, Inc. (“Revelation”) issued a joint press release announcing the execution of the Agreement and Plan of Merger between PAI, Revelation and Petra Acquisition Merger, Inc. (the “Merger Agreement”), and announcing that PAI and Revelation will hold an investor conference call on August 30, 2021 at 4:30 p.m. Eastern Time (the “Conference Call”). Attached hereto as Exhibit 99.1 and incorporated into this Item 7.01 by reference is the copy of the joint press release issued on August 30, 2021 by PAI and Revelation announcing the execution of the Merger Agreement. Attached hereto as Exhibit 99.2 and incorporated into this Item 7.01 by reference is the script for the Conference Call.
Attached hereto as Exhibit 99.3 and incorporated into this Item 7.01 by reference is the investor presentation that will be used by PAI in making presentations to certain existing stockholders of PAI and other persons with respect to the transactions contemplated by the Merger Agreement.
The information in this Item 7.01 (including Exhibits 99.1, 99.2 and 99.3) is being furnished and shall not be deemed to be filed for purposes of Section 18 of the Exchange Act, or otherwise be subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act.
Important Information and Where To Find It
In connection with the Merger Agreement and transactions contemplated thereby, PAI intends to file relevant materials with the SEC, including a Registration Statement on Form S-4, which will include apreliminary proxy statement/prospectus and a definitive proxy statement/prospectus. Promptly after filing its definitive proxy statement with the SEC, PAI 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 PAI ARE URGED TO READ THESE MATERIALS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS IN CONNECTION WITH THE TRANSACTION THAT PAI WILL FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT PAI, REVELATION AND THE TRANSACTION. The Registration Statement, definitive proxy statement/prospectus, and other relevant materials in connection with the transaction (when they become available), and any other documents filed by PAI with the SEC, may be obtained free of charge at the SEC’s website (www.sec.gov).
Participants in the Solicitation
PAI and its directors and executive officers may be deemed participants in the solicitation of proxies from PAI’s stockholders with respect to the proposed business combination. A list of the names of those directors and executive officers and a description of their interests in PAI will be included in the proxy statement/prospectus 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/prospectus for the proposed business combination when available. Information about PAI’s directors and executive officers and their ownership of PAI common stock is set forth in PAI’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 from the sources indicated above.
REVELATION and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the stockholders of PAI 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/prospectus for the proposed business combination.
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Forward-Looking Statements
This Current Report on Form 8-K and the documents incorporated by reference herein (this “Current Report”) contain certain “forward-looking statements” within the meaning of “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, as amended, . Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “shall,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” “forecast,” “intend,” “plan,” “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Examples of forward-looking statements include, among others, statements made in this Current Report regarding the proposed transactions contemplated by the Merger Agreement, including the benefits of the Merger, integration plans, expected synergies and revenue opportunities, anticipated future financial and operating performance and results, including estimates for growth, the expected management and governance of the combined company, and the expected timing of the Merger. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on PAI’s and REVELATION’s managements’ current beliefs, expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, the following: (1) 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; (2) the inability to complete the transactions contemplated by the Merger Agreement due to the failure to obtain approval of the stockholders of PAI or Revelation or other conditions to closing in the Merger Agreement; (3) the inability to project with any certainty the amount of cash proceeds remaining in the PAI trust account at the closing of the transaction; (4) the uncertainty relative to the cash made available to Revelation at the closing should any material redemption requests be made by the PAI stockholders (since the sources of cash projected in this press release assume that no redemptions will be requested by PAI stockholders); (5) the inability of the company post-closing to obtain or maintain the listing of its securities on Nasdaq following the business combination; (6) the amount of costs related to the business combination; (7) 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; (8) 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; (9) the ability of Revelation to meet its post-closing financial and strategic goals, due to, among other things, competition; (10) the ability of the company post-closing to grow and manage growth profitability and retain its key employees; (11) 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; (12) the clinical utility of an increase in intranasal IP-10 levels as a treatment for viral infections; the ability to complete planned clinical studies of REVTx-99; (13) expected initiation of the clinical studies, the timing of clinical data; (14) the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; (15) the outcome of data collected, including whether the results of such data and/or correlation can be replicated; (16) the timing, costs, conduct and outcome of our other clinical studies; (17) 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; (18) the success of future development activities for REVTx-99 and expanded indications, REVTx-200, REVDx-501, or any other product candidates; (19) potential indications for which product candidates may be developed; (20) the potential impact that COVID-19 may have on Revelation’s suppliers, vendors, regulatory agencies, employees and the global economy as a whole; (21) the expected duration over which Revelation’s balances will fund its operations; (22) and other risks and uncertainties described herein, as well as those risks and uncertainties indicated from time to time in the final prospectus of PAI for its initial public offering dated October 7, 2020 filed with the SEC and the proxy statement on Schedule 14A relating to the proposed business combination, including those under “Risk Factors” therein, and in PAI’s other filings with the SEC. PAI cautions that the foregoing list of factors is not exclusive. PAI and REVELATION caution readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. PAI and REVELATION do not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its their expectations or any change in events, conditions, or circumstances on which any such statement is based.
No Offer or Solicitation
This Current Report on Form 8-K 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.
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Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1* | Press Release dated August 30, 2021 | |
| 99.2* | Conference Call Script | |
| 99.3* | Investor Presentation dated August 30, 2021 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
| * | Furnished but not filed. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: August 31, 2021 | ||
PETRA ACQUISITION INC. |
||
| By: | /s/ Andreas Typaldos | |
| Name: | Andreas Typaldos | |
| Title: | Chief Executive Officer | |
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Exhibit 99.1
Revelation Biosciences, Inc., a Life Sciences Company Developing Therapeutics and Diagnostics for Respiratory Viral Infections, Including COVID-19, to Become Publicly Traded through a Merger with Petra Acquisition, Inc.
| ● | Revelation’s lead product candidate REVTx-99, has potential, through innate immune system stimulation, to broadly prevent or treat infections caused by various respiratory viruses such as SARS-CoV-2 including its variants, influenza A and B, parainfluenza, rhinovirus, and respiratory syncytial virus (RSV). |
| ● | Combined company expected to have a post-transaction pro forma total enterprise value of approximately $128 million |
| ● | Merger expected to close in Q4 2021, and combined company will be listed on NASDAQ under the ticker symbol “REVB” |
| ● | Revelation and Petra Acquisition will host a joint investor conference call and webcast to discuss the proposed transaction on August 30, 2021 at 4:30 p.m. Eastern Time. The conference call can be accessed by dialing 877-407-0792 for domestic callers and 201-689-8263 for international callers. Please provide the operator with the conference ID number 13722753 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. |
NEW YORK, NY & SAN DIEGO, CA – August 30, 2021 – Revelation Biosciences, Inc. (“Revelation”), a clinical-stage life sciences company focused on the development of immunologic-based therapies for the prevention and treatment of disease, and Petra Acquisition, Inc. (“Petra”) (NASDAQ: PAICU, PAIC, & PAICW), a special purpose acquisition company (“SPAC”), today announced they have entered into a definitive merger agreement for a business combination that will result in Revelation becoming a publicly traded company.
An Urgent Need for Prevention and Treatment of Respiratory Infections
In 2019, lower respiratory tract infections (LRTIs), including pneumonia and bronchiolitis, affected 489 million people globally. 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.
The burden of respiratory infections on the healthcare system and economy is significant, with respiratory infections leading to more doctor visits and absences from school and work than any other illness. In addition, recent studies suggest a troubling increase in deaths from these viruses.
Beyond this, a recent study from Houston Methodist shows a rapid return of seasonal respiratory viruses after COVID-19 restrictions were relaxed in the state of Texas. In England, positive RSV samples among suspected cases in children have increased from 1.2% to 8.9%, which is of particular concern to local health leaders given the disease is most common during the winter months.
The global pandemic brought on by COVID-19, with over 4.4 million deaths globally, has only heightened the need for easy-to-use, effective therapies that prevent the user from becoming infected, or that activate the innate immune system to combat early infections.
As respiratory infections impact populations and economies around the world – including the global pandemic brought on by COVID-19 – Revelation is developing innate immune system based therapeutics and diagnostics for the identification, prevention and treatment of respiratory diseases.
Revelation – Proven Leadership with Extensive Product Development Experience Across Multiple Indications
Revelation’s leadership and scientific teams bring extensive product development experience across multiple indications, spanning all stages of drug development, including 8 FDA and EMA approvals. The leadership team has a successful track record in multiple startups and turn-arounds including, 3 NASDAQ and 1 NYSE listings.
Currently, Revelation has several product candidates in development:
| ● | REVTx-99, the lead therapeutic candidate, is a broad anti-viral nasal drop solution that can be used 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 works by boosting the body’s innate immune system, preventing the user from becoming infected or activating the innate immune response to combat early infection. REVTx-99 is also being developed for the treatment of chronic nasal congestion. Revelation has completed a Phase 1 clinical study testing the safety, pharmacokinetics and pharmacodynamics of REVTx-99. REVTx-99 was well tolerated and stimulated significant production of Interferon-Induced Protein-10 (IP-10). |
Revelation plans to start a Phase 2 viral challenge study in the first quarter of 2022, as well as a Phase 1 proof of concept study, which is intended to support the chronic nasal congestion program, in the fourth quarter of 2021.
| ● | 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. |
| ● | REVDx-501 is a rapid point-of-care diagnostic that can be used to detect various respiratory viral infections regardless of virus type without the need for specialized instrumentation. Data collected to date shows that results correlate well with PCR for COVID-19 (100% positive agreement for replicating virus). |
Transaction Overview
Pursuant to the merger agreement, Revelation will merge with a wholly owned subsidiary of Petra, with Revelation being the surviving entity of the merger and a wholly owned subsidiary of Petra. Petra, which currently holds approximately $73 million of cash in trust, will be renamed to Revelation Biosciences, Inc. following the merger. The combined entity will have an estimated pro forma enterprise value of approximately $128 million. Assuming no trust account redemptions by Petra’s public stockholders, Revelation’s existing stockholders will own approximately 54% of the fully diluted shares of common stock of the combined company immediately following the closing of the business combination.
The combined company expects to receive approximately $73 million in gross proceeds from the trust account, assuming no redemptions by Petra’s existing public shareholders. The cash proceeds from the transaction are expected to fund the continued development of REVTx-99, Revelation’s lead therapeutic candidate. REVTx-99 is being developed to prevent or treat respiratory viral infections and chronic nasal congestion. Proceeds from the transaction will also be used to fund the continued development of REVDx-501, a rapid point-of-care diagnostic that can be used to detect various respiratory viral infections, regardless of virus type and without the need for specialized instrumentation.
Following the closing of the transaction, the company will be led by existing management from Revelation, including CEO James Rolke.
The transaction has been approved by the Board of Directors of both Petra and Revelation and is subject to the satisfaction of customary closing conditions, including the approval of Petra’s stockholders. The transaction is expected to close in the fourth quarter of 2021.
Additional information about the proposed business combination, including a copy of the merger agreement and investor presentation, will be provided in a Current Report on Form 8-K to be filed by Petra with the Securities and Exchange Commission (the “SEC”) and available at www.sec.gov. In addition, Petra Acquisition, Inc. intends to file a registration statement on Form S-4 with the SEC, which will include a proxy statement/prospectus, and will file other documents regarding the proposed transaction with the SEC.
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Management Comments
“We have all seen the crippling effects on lives and economies when a virus takes over,” said James Rolke, Chief Executive Officer of Revelation. “We believe innovations like REVTx-99 will enable a return to normalcy, alleviating concerns about exposure to severe respiratory infections. The mechanism of REVTx-99, which activates the innate immune system, has the potential to reduce the exposure risks associated with travel, medical care and normal daily interactions by preventing and combating early infection. Our merger with Petra Acquisition will provide the capital needed to further our innovations and ensure they are widely available to transform the prevention and treatment landscape of viral respiratory diseases which lead to millions of deaths annually as well as immense healthcare and economic disruptions.”
“Revelation Biosciences represents an opportunity to dramatically reduce the impact and severity respiratory infections have on our lives,” said Andreas Typaldos, CEO and Chairman of the Board of Petra. “This transaction will provide James and the proven leadership team at Revelation the capital necessary to continue innovating in the world of innate immune system therapeutics and diagnostics – the first step towards a healthier future.”
Investor Conference Call Information
Revelation and Petra will host a joint investor conference call and webcast to discuss the proposed transaction on August 30, 2021 at 4:30 p.m. Eastern Time. The conference call can be accessed by dialing 877-407-0792 for domestic callers and 201-689-8263 for international callers. Please provide the operator with the conference ID number 13722753 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.
Advisors
| ● | Roth Capital Partners is acting as financial advisor to Revelation |
| ● | LifeSci Capital is acting as financial and capital markets advisor to Petra |
| ● | Loeb & Loeb LLP is acting as legal counsel to Petra |
| ● | Fox Rothschild LLP and J.P. Galda & Co are acting as legal counsel to Revelation |
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 point-of-care 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.
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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: 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 treatment for 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.
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Important Information for Investors and Stockholders
This press release relates to a proposed transaction between Petra Acquisition, Inc. and Revelation Biosciences, Inc. This press release does not constitute either (a) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination or (b) an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
Petra intends to file a registration statement on Form S-4 with the SEC, which will include a document that serves as a prospectus and proxy statement of Petra, referred to as a proxy statement/prospectus. The proxy statement/prospectus will be sent to all Petra and Revelation shareholders after the registration statement is declared effective by the SEC. Petra will also file other documents regarding the proposed transaction with the SEC. This press release does not contain all of the information that will be contained in the proxy statement/prospectus or other documents filed with the SEC. Before making any voting decision, investors and security holders of Petra and Revelation are urged to read the registration statement, the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC in connection with the proposed transaction as they become available because they will contain important information about the proposed transaction.
Investors and security holders will be able to obtain free copies of the registration statement, the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by Petra through the website maintained by the SEC at www.sec.gov or by sending a written request to Petra at: sean.fitzpatrick@petraacquisition.com.
Participants in the Solicitation
Petra and its directors and executive officers may be deemed to be participants in the solicitation of proxies from Petra’s shareholders in connection with the proposed transaction. A list of the names of such directors and executive officers and information regarding their interests in the proposed business combination will be contained in the proxy statement/prospectus when available. You may obtain free copies of these documents as described in the preceding paragraph.
Revelation and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from Petra’s stockholders in connection with the proposed transaction. A list of the names of such directors and executive officers and information regarding their interests in the proposed business combination will be contained in the proxy statement/prospectus when available. You may obtain free copies of these documents as described in the second preceding paragraph.
For Revelation Biosciences, Inc.:
Investor Contact:
Sandra Vedrick
Vice President, Investor Relations & Human Resources
Revelation Biosciences Inc.
Email: svedrick@revbiosciences.com
Media contact:
Kristin Faulder
kristin@heurisay.com
For Petra Acquisition, Inc.:
Contact:
Sean Fitzpatrick
Chief Financial Officer
sean.fitzpatrick@petraacquisition.com
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Exhibit 99.2
Petra
Andreas Typaldos
CEO
| 1. | Thank you everybody for taking the time to learn about Petra’s merger with Revelation Biosciences. I’m excited to present this opportunity to you after looking at a number of potential companies for Petra to merge with. |
| 2. | I think you will share our excitement at Petra about Revelation. Both because of the opportunity that its merger with Petra represents for Petra’s shareholders. And because of the better health outcomes that could result, for a large segment of healthcare – for people with viral respiratory diseases and COVID-19. |
| 3. | Our excitement stems from a couple of reasons: |
| a. | As always, first and foremost is the Revelation Team, whom I will introduce shortly. 3 NASDAQ and one NYSE listing are testament to the ability of the mgt and scientific teams to deliver on product development across multiple indications, spanning all stages of drug development, including 8 FDA and EMA approvals. So, we feel confident about Revelation’s ability to execute and deliver on their business plan |
| b. | Secondly, the therapeutic market of respiratory viral infections and COVID-19 that Revelation is addressing is significant. And, with current COVID-19 developments, it’s urgent and global. |
| c. | Third, Revelation has developed unique technology in connection with its products that the management team will describe. |
| 4. | So, without further delay, it’s time to meet the Revelation Team. They will describe the Company. Its products and technology. The development path and timeframes. The market, and potential health outcomes for the hundreds of millions of people suffering from viral infectious diseases and COVID-19. And the CFO will also go over the transaction itself. |
Then, I think, the prospects and opportunity for the combined company’s shareholders, employees, and many constituencies will be clear and I believe compelling.
So, it’s now my pleasure to introduce Sandra Vedrick, Revelation’s VP of IR and HR, and the Revelation management team. Sandra?
Revelation
Sandra Vedrick
Vice President IR & HR
Thank you, Andy and thank you for taking time to learn about Revelation Biosciences and its merger with Petra.
A copy of the press release is available on Revelation’s website at RevBiosciences.com.
Page 1 of 7
I’d like to remind everyone that today’s call is being recorded and the replay can be found our website.
This conference call today will contain certain forward-looking statements, and this must be viewed in conjunction with the risks that our business entails. Please read Forward-Looking Statements discussion on slide 3 of our corporate slide deck, a copy of which will be attached to Petra’s SEC Form 8-K to be filed with the SEC. Petra will be filing a registration statement with the SEC containing more complete information regarding our business and the proposed transaction and investors should not rely solely on this presentation to make any investment decision.
Thank you and I’ll turn the presentation over to our CEO, James Rolke
Revelation
James Rolke
CEO
Slide 4:
Thank you Sandra and thank you Andreas.
And thank you to the audience for taking the time to learn a little more about revelation biosciences. I am very excited to present to you as we have made significant progress since our inception in May of 2020.
The Covid-19 pandemic really exposed gaps in our ability to detect, treat and prevent respiratory viral infections. Aside from COVID, there are many other existing viruses that have significant social and economic impact, in particular influenza.
Vaccines are only part of the solution as they are very pathogen specific, and their effectiveness can be limited due to viral mutations. We may be starting to see this with the COVID-19 variants.
Revelation decided to take a different approach and develop products that would potentially work pan-virally, meaning for multiple types of virus and viral mutations.
Slide 5:
We accomplished this by developing our products based on modulation or measurement of the innate immune response.
To remind everyone, the innate immune response is our primary defense against infection that is mainly driven by the production and activity of multiple cytokines and chemokines.
These cytokines and chemokines act immediately upon the start of an infection and work in non-specific ways to blunt the ability of a virus to proliferate and survive.
In addition, cytokines and chemokines recruit the adaptive immune response leading to the generation of pathogen specific antibodies. These antibodies take time to develop. This is where vaccines play a role.
Again, Revelation is taking advantage of the innate immune response.
Slide 6.
The 4 key messages I’d like to make today are that we:
| a. | Have a multiple products in development that are broadly applicable to many types of viral infection and also have potential uses beyond viral infection. | |
| b. | Our products are all based on a solid scientific foundation and our early clinical biomarker and safety data supports continued development | |
| c. | We have multiple near-term value driving milestones and | |
| d. | We have assembled an excellent management and scientific team with a strong track record for developing drugs and growing organizations. |
Slide 7.
Our pipeline consists of our lead product REVTx-99, which is being developed first as a potential treatment for preventing and possibly treating early respiratory viral infection.
In addition, REVTx-99 may also be useful for treating chronic nasal congestion due to allergies or chronic rhinosinusitis.
REVTx-200 is our intranasal adjunct to an IM vaccine to provide a more complete immunization
And finally, REVDx-501 is our rapid at home universal screening test for any type of respiratory infection.
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Slide 8.
As I mentioned, we have several near-term value driving milestones. Most importantly, the start of the phase 2 viral challenge study with influenza in the first quarter of 2022 and the start of the phase 1b allergen challenge study at the end of this year.
Slide 9.
Now I’m going to tell you a little more about REVTx-99
Slide 10.
REVTx-99 is given intranasally. The active ingredient is called PHAD.
PHAD interacts with toll-like receptor 4, TLR4, which is widely expressed in the nasal mucosa.
This interaction stimulates the TRIF pathway which leads to the production of multiple protective cytokines and chemokines, including interferons that again work to blunt the ability of a virus to survive and proliferate.
Slide 11.
Interestingly, clinical studies using interferon-alpha drops showed a substantial reduction in clinically confirmed infections for multiple virus types vs. placebo.
Since REVTx-99 produces multiple protective cytokine including interferons, it is believed REVTx-99 will work as well if not better than any single interferon alone.
Slide 12.
In addition, PHAD was studied in a preclinical lethal influenza virus challenge model. As indicated, when given prior to the challenge, PHAD imparted significant protection vs. no treatment.
Slide 13.
Based on this strong scientific foundation we conducted a phase 1 healthy volunteer study.
The primary endpoints were safety and pharmacodynamic effects as measured by intranasal cytokines.
The study consisted of 6 cohorts, the first 5 were single ascending doses and the 6th was 5 daily doses at the highest dose.
Slide 14.
From a safety perspective, REVTx-99 was very well tolerated with no significant or serious adverse events. All adverse events associated with the drug were mild in nature and limited to the local nasal mucosa at the highest doses.
From a biomarker perspective, REVTx-99 induced the production of several protective cytokines including IP10 a key cytokine of interest. As indicated, IP10 was significantly upregulated vs placebo.
Slide 15.
IP10 was chosen a priori as a key cytokine of interest for several reasons, principally.
It is an excellent surrogate for interferons as interferons are required to get to IP10
It is a known TRIF dependent cytokine
And increases in IP10 have been shown to be protective in clinical viral challenge studies with influenza and rhinovirus.
Slide 16.
Here is a box and whisker plot of all IP10 data collected regardless of time. As you can see, there is a nice dose dependent response for intranasal IP10, but also importantly, there is no increase in systemic IP10 which again speaks to the local nature of the drug and its potential safe usage.
Slide 17.
In addition to IP10, several other TRIF dependent cytokines were also upregulated and tracked with IP10. Importantly IL6, an inflammatory cytokine, was not upregulated which again speaks to the drugs potential safety.
Slide 18.
Based on the positive outcome from the phase 1 study, we plan to conduct a phase 2 influenza viral challenge study with REVTx-99 starting in the 1st quarter of 2022. Success in this study is highly predictive of success in later stage real world studies.
Page 3 of 7
Slide 19.
For prevention of viral infection, REVTx-99 may have several broad marketing opportunities.
For seasonal prophylaxis, REVTx-99 would be given to high risk individuals, such as hospital workers, over the course of a season (e.g. the flu season).
For the situational and contact prophylaxis, REVTx-99 would be given over the course of 1 to several days to individuals such as travelers or visitors to a hospital.
Slide 20.
During formulation development it was observed that REVTx-99 may be beneficial for people with allergies or chronic rhinosinusitis.
Slide 21.
The rationale for why this would be is two-fold. First, the protective cytokines produced by REVTx-99 may shift the immune system from an inflammatory state to a more protective state.
And second, the IP10 generated by REVTx-99would compete for the same receptor as Eotaxin. Eotaxin is a chemokine that promotes the allergic response. This competition would result in a down regulation of the allergic response.
Slide 22.
We plan to evaluate REVTx-99 as both a prevention and a treatment in a phase 1b allergen challenge study starting later this year.
Slide 23
REVTx-200 is an earlier stage program, where…
Slide 24.
REVTx-200 would be given intranasally, concurrently with an intramuscular vaccine to give a more complete immunization.
Most respiratory viral vaccines are given IM including all the current COVID vaccines.
While intramuscular vaccination results in a strong systemic immunity, it does not elicit a strong mucosal (for example in the nose) immunity. Since most respiratory viruses enter through the nose this would be desired.
REVTx-200 is believed to work by stimulating protective cytokines and chemokines.
And these work to recruit activated B and T-cells from the systemic space into the mucosal space resulting in a stronger mucosal immunity.
Our plan is to study REVTx-200 in nonclinical studies in the first part of 2022.
Slide 25
Now I’ll tell you a little about our rapid, easy to use at-home diagnostic REVDx-501 also known as REVID
Slide 26
Like all our product candidates, REVID works to detect multiple types of viral infection.
It is similar to a pregnancy test, in that the user collects a sample from the lower portion of the nose, not way up like other products, applies the sample to the application pad and waits about 15 minutes for a result that is read visually
The result is a simple Yes I have a respiratory viral infection or No, I don’t have a respiratory viral infection.
Slide 27.
As such, REVID can be used a universal screening tool to allow for testing of large numbers of people rapidly and inexpensively.
Slide 28.
Like REVTx-99, REVID has multiple potentially broad markets. Most importantly as an individual screening tool that allows the user to make informed decisions on their general health and whether to quarantine or go about their daily lives.
Slide 29.
Testing has shown that the REVID kit correlates very well with PCR for COVID with a 0% false negative rate, meaning no one with an active COVID infection was allowed through the test.
The 14% false positive rate is artificially high.
Those subjects who tested positive using REVID, but negative for COVID by PCR, when subjected to additional PCR testing were shown to have infection with another virus type like rhinovirus, influenza and other coronaviruses.
Thus, the test works as it is supposed to as a universal screening tool.
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Slide 30.
Pause and then advance
Slide 31.
Our Board is comprised of industry veterans with skills that are complimentary to those required to develop drugs and grow companies.
Slide 32.
In addition, we have assembled a fantastic management and scientific team with proven track records of success.
Slide 33.
Lastly, I want to remind you of the four key takeaways.
We have multiple products in development with broad applicability to viral infection and beyond
Our product candidates are all based on a strong scientific foundation
We have several near-term value driving milestones including two clinical studies
And we have the right management and scientific team to get it done.
With that, I’ll turn it over to Chester Zygmont our CFO, to talk about the transaction.
Revelation
Chester Zygmont III
CFO
Transaction Overview:
Thank you James.
Slide 35
Highlights from the transaction between Revelation and Petra include Petra’s IPO in October 2020 of approximately $74 million, which under the rules governing SPACs is held in trust and will be released to the company, after closing following any requested redemptions,
Revelation is to receive stock consideration totaling $105 million, this is an issuance of 10.5 million Petra shares at the IPO price of $10, and after the transaction is closed, the net proceeds remaining in the Petra trust account, after payment of expenses, will be available to help fund the continued development of the company’s therapeutic and diagnostic candidates.
When we refer to the continued development of our therapeutic and diagnostic candidates, the therapeutic includes the Phase 2 Viral Challenge Study, and further program development needs to reach a Phase 3 study.
This also includes a Phase 1 study of REVTx-99 for the treatment of chronic nasal congestion and the continued development of REVDx-501, our diagnostic candidate.
Assuming limited redemptions, our expected runway of this cash brings us into Q2 of 2023.
In addition, the Revelation leadership – both management and board – will be the successors of the company.
Revelation is also expected to be traded on Nasdaq under the ticker symbol, REVB, after the closing of the transaction, expected in Q4 of 2021.
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Slide 36
Examining the transaction overview, under the Sources and Uses previously mentioned, Petra has $73.5 million in trust with an equity rollover of $105 million for Revelation, and Petra’s Sponsor having $18.4 million totaling $196.9 million dollars from the Sources.
Looking at the Uses, two items that stand out are the net cash to Revelation’s balance sheet of approximately $65 million, with assumed transaction expenses of $8.5 million.
The approximate $65 million in net proceeds, however, assumes no investor redemption of amounts from the Petra trust fund.
This assumption is not necessarily indicative of what has been realized by other similar SPAC transactions and at this point in time we cannot offer assurances as to the amount we will yield from the trust.
On a Proforma basis, the equity value of the company is $197.9 million with a Proforma Enterprise value $127.7 million.
In the area of Proforma Ownership, Revelation shareholders will hold 53.6% of the company, the Petra public shareholders will hold 37.1%, and the Petra Sponsor will hold 9.3% of the overall company after the close.
The proforma ownership estimates also assume that Petra shareholders will not request redemption of any of their shares.
Beneficial Holders:
Slide 38 -
Regarding Revelation’s beneficial holders prior to the merger, currently Dr. George Tidmarsh our chairman and largest single shareholder, holds 17.5% of Revelation’s shares on a fully diluted basis.
The Company management holds 30.7% of Revelation’s shares, on a fully diluted basis. Institutions that hold Revelation stock include, AXA Prime Impact Fund, LifeSci Venture Partners, and Monashee investments.
Management’s ownership of Petra will be based on that portion of the 10.5 million Petra shares to which they are entitled on a proforma basis.
At this time I will turn it back over to James.
Revelation
James Rolke
CEO
Thank you Chester, and thank everyone for taking the time to listen about Revelation Biosciences. At this time we will open for questions. Sandra?
Revelation
Sandra Vedrick
Vice President IR & HR
Thank you, James.
Page 6 of 7
We will proceed with your questions and I would like to caution each of you that our comments may be limited in some regard under applicable securities laws. First, to the extent any of our responses contain forward-looking statements, any such forward-looking statements are qualified as being subject to a number of risks and uncertainties, and our actual results may differ materially. Certain of the factors that may have an effect on any such forward-looking statements are identified in Petra’s SEC filings and other public documents. Our comments will be further limited in accordance with SEC Regulation FD, as this meeting is not deemed by the SEC to be a Regulation FD compliant forum; thus, we are only allowed to provide information that is currently available in Petra’s public filings. Operator?
Revelation
James Rolke
CEO
Thank you for taking the time to learn about Revelation Biosciences. Good bye.
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Exhibit 99.3
Using cutting edge science to develop innovative therapeutics and diagnostics Corporate Presentation / August 2021
Legal Disclaimer About this Presentation This presentation is provided for informational purposes only and is subject to change . The information contained herein does not purport to be all - inclusive . The data contained herein is derived from various internal and external sources, and may rely upon assumptions, stated or otherwise, and forward - looking statements discussed on page 3 of this presentation . No representation is made as to the reasonableness of the assumptions made within or the accuracy or completeness of any forward - looking statements, modeling or any other information contained herein . Petra Acquisition, Inc . (“Petra”) and Revelation Biosciences Inc . (“Revelation” or “Company”) assume no obligation to update the information in this presentation . This material is not for the benefit of, and does not convey any rights or remedies for the benefit of, any holder of securities or any other person . This material is not intended to provide the basis for evaluation of any transaction and does not purport to contain all information that may be required and should not be considered a recommendation or opinion of any kind with respect to any transaction . Important Information and Where to Find It In connection with the proposed business combination, Petra intends to file with the SEC a registration statement on Form S - 4 covering Petra’s securities to be issued to the security holders of Revelation at the closing of the business combination, which registration statement will contain preliminary and definitive proxy statements of Petra in connection with a special meeting of the stockholders of Petra to consider and vote on the business combination and related matters . Petra will mail the definitive registration statement on Form S - 4 containing the definitive proxy statement and other relevant documents to its stockholders in connection with the meeting . Investors and security holders of Petra and Revelation are advised to read, when available, the draft of the registration statement, the preliminary proxy statement, and amendments thereto, and the definitive registration statement and proxy statement, which will contain important information about the proposed business combination and the parties to it . The registration statement and definitive proxy statement will be mailed to stockholders of Petra and Revelation as of a record date to be established for voting on the proposed business combination . Stockholders will also be able to obtain copies of the registration statement and proxy statement, without charge, once available, at the SEC’s website at www . sec . gov . Participants in the Solicitation Petra, Revelation and their respective directors, executive officers and other members of their management and employees, under SEC rules, may be deemed to be participants in the solicitation of proxies of Petra stockholders in connection with the proposed business combination . Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies to Petra’s stockholders in connection with the proposed business combination will be set forth in the proxy statement for the proposed business combination when available . Information concerning the interests of Petra’s and Revelation’s participants in the solicitation, which may, in some cases, be different than those of Petra’s and Revelation’s stockholders generally, will be set forth in the proxy statement relating to the proposed business combination when it becomes available . No Offer or Solicitation This material is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed transaction 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 any such 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 Section 10 of the Securities Act of 1933 , as amended . 2
Forward - Looking Statements Certain statements made herein are "forward - looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 . Forward - looking statements may be identified by the use of words such as "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters . Such forward - looking statements include timing of the proposed business combination ; the business plans, objectives, expectations and intentions of the parties once the proposed business combination is complete, and Petra’s and Revelation’s estimated and future results of operations, business strategies, competitive position, industry environment and potential growth opportunities, relating to the acquired business . These forward - looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties . As a result, caution must be exercised in relying on forward - looking statements . Due to known and unknown risks, our actual results may differ materially from our expectations or projections . The following factors, among others, could cause actual results to differ materially from those described in these forward - looking statements : 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 ; should any material redemption requests be made by the Petra stockholders (since the sources and uses of cash projected in this presentation assume that no redemptions will be withdrawn from the Petra trust account) ; whether the amount of redemption requests made by the Company’s stockholders will exceed the zero amount projected in this presentation ; the inability to obtain or maintain the listing of the post - acquisition company’s securities on Nasdaq following the business combination ; costs related to the business combination ; the Company’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 amount 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 the combined company to meet its financial and strategic goals, due to, among other things, competition, the ability of the combined company to grow and manage growth profitability and retain its key employees ; the possibility that the combined company 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 treatment for viral infections and whether this data can be replicated in future clinical studies for REVTx - 99 ; the timing, costs, conduct, and outcome of clinical studies ; the ability to achieve project milestones and their timing and costs ; the impact of the ongoing COVID - 19 pandemic on our business and operations, including enrollment in our clinical trials, our continued reliance on third parties to conduct additional clinical trials our current and future product candidates, and for the manufacture of Revelation’s product candidates ; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities ; potential indications, for which our drug candidates may be developed ; market potential and patient population ; and the expected duration over which Revelation's cash 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 Securities and Exchange Commission (the “SEC”) by Petra . 3
Respiratory Viral Infections: A Perpetual Problem • COVID - 19 exposed gaps in currently approved methods to diagnose, prevent and treat respiratory viral infections • Existing and emerging respiratory viruses effect large numbers of people annually and have a substantial social and economic impact. Prior to COVID - 19, influenza alone was responsible for $87B economic impact annually • Vaccines are an important tool, but due to viral mutation, vaccines are only part of the solution as their effectiveness has been as low as 25% and each virus requires a separate vaccine • Our products are being developed to work pan - virally. Influenza RSV SARS - CoV - 2 Annual Cases 9 - 45 million ~33 million Annual Hospitalizations 14,000 - 810,000 ~250,000 Annual Deaths 12,000 - 61,000 ~14,000 ~600,000 4 CDC March 15, 2021
Revelation Biosciences – Our Focus 5 • The innate immune response is our first line of defense against viral invasion • The innate response is non - specific and is immediately activated upon viral invasion • It works via the production and activity of cytokines and chemokines that inhibit the ability of the virus to proliferate and recruit the adaptive immune response • Revelation’s products take advantage of this innate immune response Developing therapeutics and diagnostics for respiratory viral infections based on modulation or measurement of the innate immune system • The adaptive immune response results in the production of pathogen specific antibodies • The production of antibodies takes days to weeks to develop • Vaccines take advantage of the adaptive immune response Experienced Management and Scientific Team Pathogen Innate Immune Response Adaptive Immune Response • Respiratory viruses enter through the nose and mouth
Revelation Biosciences – Executive Summary 6 Revelation’s portfolio consists of three product candidates: REVTx - 99 (Phase 2), REVTx - 200 (Preclinical) and REVDx - 501 (Pre - 510(k)) REVTx - 99 is a broad anti - viral nasal drop solution in development for the prevention or treatment of respiratory viral infections including influenza A & B, SARS - CoV - 2 and its variants, parainfluenza, RSV, and emerging viruses. REVTx - 99 is also being developed for the treatment chronic nasal congestion REVDx - 501 is a diagnostic device in development for the detection of any respiratory viral infection regardless of virus type without the need for specialized instrumentation REVTx - 99 stimulates the production of multiple, local interferons and other protective cytokines via TLR - 4 agonism. Phase 1 biomarker data is supportive of continued development REVDx - 501 Rapid screen allows for virus negative patients to be eliminated, thus increasing the efficiency of SARS - CoV - 2 specific testing REVTx - 99 topline data for Phase 2 viral challenge study estimated to be available in Q2 2022 REVDx - 501 is expected to gain marketing clearance in 2H 2022 Revelation Portfolio Scientific Rationale Near Term Value Drivers Extensive product development experience across multiple indications spanning all stages of drug development including 8 FDA and EMA approvals Successful track record in multiple startups and turn - arounds including, 3 NASDAQ listings and 1 NYSE listing Experienced Management and Scientific Team
Development Pipeline 7 Pipeline consists of two therapeutic product candidates (REVTx - 99 and REVTx - 200) and one diagnostic product (REVDx - 501) Therapeutic Pipeline Discovery Preclinical Phase 1 Phase 2 Phase 3 Approval REVTx - 99 REVTx - 200 Diagnostic Pipeline Research Development Clinical Testing Approval REVDx - 501 Prevention of respiratory viral Infection Treatment of respiratory viral infection Chronic nasal congestion Adjunct to IM vaccine Detection of respiratory viral infection 510(k)
Project Milestones Project Milestone Estimated Timing REVTx - 99: Nasal drops for the prevention and/or treatment of respiratory viral infection • Completion of Phase 1 single dose escalation x Jan 2021 • Completion of Phase 1 multidose cohort x Mar 2021 • Phase 1 clinical Proof - of - Principle data x Mar 2021 • Initiate Phase 2 influenza viral challenge study Q1 2022 • Phase 2 influenza viral challenge study top line data Q2 2022 • Initiate Phase 3 study for the prevention of respiratory viral infection Q4 2022 • Initiate Phase 1 study for treatment of chronic nasal congestion Q4 2021 REVTx - 200: Nasal drops for the improvement of IM vaccinations • Establish relation with vaccine development company(s) 1H 2022 • Study REVTx - 200 using established vaccines and nonclinical models 1H 2022 REVDx - 501: Point of care/at - home diagnostic for the detection of respiratory viral infection • Identify development and commercialization partner Q1 2022 • 510(k) submission 1H 2022 8
REVTx - 99 For the Prevention of Respiratory Viral Infection
REVTx - 99 Overview • REVTx - 99 is prophylaxis for respiratory viral infections ▪ Active ingredient: Phosphorylated Hexa - Acyl Disaccharide ( PHAD) ▪ Formulation: intranasal drops • Mechanism of action: REVTx - 99 stimulate s the innate immune system via TLR4 TRIF pathway agonism to produce protective cytokines including interferons (IFNs) • IFNs and other protective cytokines blunt the ability of an invading virus to replicate. Status: • Phase 1 study single and multiple dose - completed with positive top - line data • Phase 2 viral challenge study with influenza - expected to begin in Q1 2022 • REVTx - 99 • REVTx - 200 • REVDx - 501 10
Strong Scientific Rationale 4 Emerging Microbes and Infections, Dec 11, 2019 DOI: 10.1080/22221751.2019.1698271 5 Journal of Biological Chemistry, June 25, 2020 DOI: 10.1074/jbc.AC120.013788 6 Vaccine, April 2010, DOI:10.1016/j.vaccine.2010.03.062 7 Bio. Pharmacology Vol. 183, Jan. 2021, 114316 DOI:10.1016/j.bcp.2020.114316 Virus Placebo Group Infection Rate (%) IFN - ࢻ Group Infection Rate ( % ) Influenza A 22.6 6.4 Influenza B 15.8 4.3 Parainfluenza A 15.9 4.1 Adenovirus 7.2 3.1 Respiratory Syncytial Virus 2.8 0.8 IFN - ࢻ is beneficial for reducing clinically confirmed respiratory infection against multiple virus types in humans 3 • Influenza and coronavirus viruses can block interferon production, 1,2 leading to more severe disease 3 • Interferon have been shown to be effective vs influenza 4 and SARS - COV - 2 5 in vitro • Exogenous interferons have been shown to be effective in preventing respiratory viral infections in humans 6 • REVTx - 99 stimulates the production of protective cytokines including multiple types of interferon via TLR - 4 agonism 7 1 Virus Research, 2011, DOI :10.1016/j.viruses.2011.10.017 2 PLoS ONE, February 1, 2012, DOI:10.1371/journal.pone.0030802 3 Cell Host & Microbe 19 , pg.181 – 193, February 10, 2016 x REVTx - 99 has been shown to significantly increase key innate immune system cytokines which should translate into clinical success • REVTx - 99 • REVDx - 200 • REVDx - 501 11
PHAD is effective against viral infections due to the activation of innate immune system cytokines such as interferon Preclinical Activity of PHAD in Mouse Model 1 Trends in Microbiology, October 1, 2002, DOI: 10.1016/S0966 - 842X(02)02426 - 5 12 0 10 20 30 40 50 60 70 80 90 100 -3 -2 -1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Percent survival Days post influenza challenge PHAD (Day -2) PHAD (Day 0) No Treatment Researchers have shown that PHAD protects against lethal influenza virus challenge 1 • REVTx - 99 • REVDx - 200 • REVDx - 501
• Total number of subjects: 48 (6 cohorts, 8 subjects per cohort) • Cohorts 1 - 5: treated group (N=6) receives a dose of either 5, 15, 30, 50 or 100 µg • Cohort 6: treated group (N=6) receives a dose of 100 µg daily x 5 • Readouts : Safety measurements, systemic and nasal cytokine levels, systemic pK • Primary Endpoints: a) Safety and tolerability of REVTx - 99 from Day 1/Predose through End - of - Study (EOS) b) Pharmacodynamic effect from Day 1/Predose to EOS • Secondary Endpoints: a) Change in serum cytokine levels from screening to EOS b) Treatment emergent adverse events (TEAEs) from Day 1/Hour 0 through study completion • Exploratory Endpoints: a) Plasma PK levels 13 RVL - HV01: Phase 1 Healthy Volunteer Study with REVTx - 99 Study Endpoints Study Design RVL - HV01: A Phase 1, Placebo - Controlled, Single Dose, Escalating Dose, Followed by Multiple Dose Study to Determine the Safety and Tolerability of Intranasal REVTx - 99 in Healthy Adult Volunteers in Australia Study Title • REVTx - 99 • REVDx - 200 • REVDx - 501
Summary of Phase 1 Study Results Safety • All doses of REVTx - 99 were well tolerated with no significant or serious adverse events • Drug related adverse events were all mild and limited to the local nasal mucosa and included runny nose or mild nasal congest ion at the higher doses Biomarkers • REVTx - 99 significantly increased the levels of intranasal IP - 10, a key cytokine that correlates with the desired biologic activity • Additional protective cytokines were also upregulated intranasally • The inflammatory cytokine IL - 6 was not upregulated intranasally • Systemic cytokines were not upregulated supporting the concept that REVTx - 99 acts locally Conclusion x REVTx - 99 significantly increases key innate immune system cytokines predictive of clinical efficacy and this biomarker data and excellent safety profile supports continued development x 50 µg will be the dose used for the Phase 2 influenza viral challenge study IP - 10 response rate at 50 µg dose 1 A response was defined as a >5 - fold increase in IP - 10. The nostrils meeting the criteria of a response were assigned a 1, those that did not a 0. The percent response rate was calculated by dividing the number of responding nostrils by the total nostril s e xamined. A p - value was calculated using a t - test assuming equal variances comparing placebo to a specific dose group • REVTx - 99 • REVDx - 200 • REVDx - 501 14
1 PLoS ONE, 2011 DOI:10.1371/journal.pone.0016333 2 PREP - 001 is a TLR - 3 agonist that demonstrated effectiveness in preventing both infection with rhinovirus and influenza in human clinical studies. The primary cytokine upregulated by PREP101 is IP - 10. IP - 10 was identified a priori as the key cytokine of interest based on the following five characteristics : 1. IP - 10 production requires interferon 2. IP - 10 is a known TRIF dependent cytokine 1 that attracts and activates macrophage and dendritic, natural killer cells, and activated T lymphocytes 3. IP - 10 is readily measured in nasal mucosal samples 4. IP - 10 is actively upregulated at the onset of respiratory viral infection (e.g., infection with influenza, SARS - CoV - 2, rhinoviru s) 5. Stimulation of IP - 10 has been shown to track with clinical efficacy in clinical viral challenge studies 2 For the RVL - HV01 study, the average fold - change per nostril from baseline for placebo IP - 10 was 1.5 - fold with a standard deviation of ± 1.4. 2 standard deviations = 4.3 - fold placebo (95% Confidence interval) Response based on PREP - 001 data: • PREP median baseline : 550 pg/mL • PREP median value post dose : 1920 pg/mL • Fold - change from baseline : 3.5 - fold 15 RVL - HV01: Primary Endpoint – Pharmacodynamic Effect on IP - 10 Interferon - induced Protein 10 (IP - 10) was identified a priori as the key cytokine of interest Response based on PREP - 001 Data 2 Response based on placebo • REVTx - 99 • REVDx - 200 • REVDx - 501 Response rate Based on the above, we defined a response of >5 - fold increase in IP - 10 as clinically meaningful
Placebo N: 88 Mean: 1.5 50 ug N: 48 Mean: 9.1 P: 0.06 100 ug N: 48 Mean: 16.7 P: 0.10 50+100 N: 96 Mean: 12.9 P: 0.03 50+100+multi N: 120 Mean: 10.9 P: 0.02 5+15+30 N: 144 Mean: 1.5 P: 0.9 Fold change from Baseline REVTx - 99 Produced a Dose Dependent Increase in Intranasal IP - 10 16 x REVTx - 99 stimulated an intranasal dose dependent response for IP - 10 in this Phase 1 study x REVTx - 99 did not stimulate a systemic IP - 10, supporting the concept that REVTx - 99 acts locally x Preliminary PK data shows no systemic exposure above the 5 pg /mL limit of quantitation Presented is a box and whisker plot of the fold - change values for all data and time - points including the mean fold - change and p - value calculated using a t - test comparing placebo to each data set presented • REVTx - 99 • REVDx - 200 • REVDx - 501 Placebo (Systemic) N: 88 Mean: 1.0 50 ug (Systemic) N: 48 Mean: 0.9 P: 0.27
REVTx - 99 also Stimulated other Protective Cytokines MCP - 1 and IFN - ࢽ tracked with IP - 10 0 20 40 60 80 100 120 0 200 400 600 800 1000 1200 0 50 100 150 200 MCP - 1, IFN - g (pg/mL) IP10 (pg/mL) Time (hours) IP10-Right MCP1-Right IFN-g-Right 50 µg N: 11 Rate: 27% P: 0.05 0% 5% 10% 15% 20% 25% 30% Placebo 50 ug Percent of Nostrils with >4.5 - fold change from Baseline Placebo N: 24 Rate: 4% 0% 5% 10% 15% 20% 25% 30% Placebo 50 ug Percent of Nostrils with >7.7 - fold change from Baseline Placebo N: 22 Rate: 14% 50 µg N: 12 Rate: 17% P: NS IL - 7 IL - 6 • IL - 7, another TRIF protective cytokine trended in the right direction • IL - 7 is responsible for B and T cell development • IL - 6, an inflammatory cytokine was not upregulated • MCP - 1 and IFN - ࢽ , TRIF protective cytokines • At higher doses, MCP - 1 and IFN - ࢽ were also observed and tracked well with IP - 10 • REVTx - 99 • REVDx - 200 • REVDx - 501 - - 17
• Objective: To evaluate the efficacy of REVTx - 99 in reducing influenza virus load in the upper airways during infection • Primary Endpoint: Are a under the curve (AUC) of viral load by qPCR from nasal pharyngeal swabs • REVTx - 99 • REVDx - 200 • REVDx - 501 Next Step: Phase 2 Viral Challenge Study (De - Risking for Phase 3) 18 Study Title: A Phase 2, study assessing prophylactic efficacy of intranasal REVTx - 99 in an H3N2 influenza challenge model in healthy humans • Total number of subjects: 60 • 2 cohorts (30 per cohort; 1:1 Placebo vs Treatment) • Cohort 1: REVTx - 99 Day - 2 and Day - 1 (prior to infection) 50 µg single dose (25 µg per nostril) • Cohort 2: REVTx - 99 Day - 2 (prior to infection) 50 µg single dose (25 µg per nostril) • Full protocol currently in development, including logistics • Expected study start: 1Q 2022 Objective and Primary Endpoints Study Design Status and Timing
• REVTx - 99 • REVDx - 200 • REVDx - 501 Market Need: REVTx - 99 has Multiple Possible Uses with Potentially Large Markets 19 Seasonal virus prophylaxis (e.g. influenza season ) Seasonal Prophylaxis Potential Target Population At Risk Population. For example: • Health care workers • Elderly • Immunocompromised REVTx - 99 can be taken prophylactically prior to an anticipated potential exposure Situational Prophylaxis Potential Target Population General population. For example: • Travelers • Visitors to hospitals, nursing homes 19 REVTx - 99 can be taken prophylactically to prevent infection if exposed to someone with an active infection Contact Prophylaxis Potential Target Population General population. For example: • Family • Coworkers • Visitors to a doctor’s office 19
REVTx - 99 For the Treatment of Chronic Nasal Congestion
Rationale for Chronic Nasal Congestion: Eotaxin, Allergies and REVTx - 99 21 • Eotaxin propagates allergies and inflammation • Eotaxin binds to its receptor CCR3, which is expressed on a range of different cell types • A number of effector cells associated with allergies express the CCR3 receptor 1. Eosinophils 2. Th2 Lymphocytes 3. Mast cells 4. Basophils • Mast cells, eosinophils, and basophils are aggressively cytotoxic • IP - 10 binds to CCR3 and will directly compete with eotaxin binding CCR3, limiting immediate inflammation to provide rapid relief • In addition, TRIF stimulation biases toward a Th1 cellular responses (protective), versus a Th2 cellular response (inflammatory) potentially resulting in sustained relief No REVTx - 99 With REVTx - 99 IP10 Confidential • REVTx - 99 • REVDx - 200 • REVDx - 501
Phase 1b Nasal Challenge Study (RVL - CLR01) 22 Confidential Study Title: Effect of REVTx - 99 on Nasal Challenge with Allergen in Participants with Chronic Rhinosinusitis without Polyps Milestones • Enrollment up to 28 participants, randomized 1:1 across 4 cohorts • This will be a Phase 1b, randomized, double - blind, placebo - controlled, crossover design • Enrollment up to 28 participants, across 2 drug regimen investigations (Part 1 and Part 2) • Part 1 (pre - challenge study), n=14, randomized 1:1 between 2 cohorts (7 per cohort) that will complete both treatment arms (REVTx - 99 and placebo) in a crossover manner • Part 2 (post - challenge study), n=14, randomized 1:1 between 2 cohorts (7 per cohort) that will complete both treatment arms (REVTx - 99 and placebo) in a crossover manner Study Design • Primary Objective: To evaluate the effects of REVTx - 99 versus placebo on nasal symptoms elicited by nasal allergen challenge (NAC) administered after study drug administration (Part 1) and before study drug administration (Part 2). • Primary Endpoint: Area under the curve (AUC) TNSS (0 - 60 minutes after NAC) Objective and Primary Endpoints • Site selected (Australia) • Full protocol is in development • Ethics submission planned for Q3 2021 • First patient planned to dose Q4 2021 Status and Timing • REVTx - 99 • REVDx - 200 • REVDx - 501
REVTx - 200 Intranasal PHAD ® for Improved Intramuscular (IM) Vaccination
REVTx - 200 Overview • REVTx - 200 is being developed as an intranasal adjunct to intramuscular vaccines to produce a superior, more complete immunization • REVTx - 200 is based on the same platform as REVTx - 99 • IP on formulation and method have been filed • Development rationale ▪ IM vaccination typically results in a robust immune response imparting systemic immunity, but elicitation of a weak mucosal response ▪ REVTx - 200 stimulates the mucosal immune response to induce production of secretory IgA, cytokines, and chemokines, which in turn recruit vaccine - specific T and B cells to the mucosal space, further enhancing the protection of the selected vaccine • Identify and work with multiple partners with existing vaccines to evaluate REVTx - 200 nonclinically in 1H 2022 • Initial clinical studies will likely be viral challenge in nature, post immunization • REVTx - 200 has the potential to be used with most respiratory viral vaccines currently in use or being developed • REVTx - 99 • REVDx - 200 • REVDx - 501 24
REVDx - 501 Rapid testing kit for viral infection
REVDx - 501: Broadly Applicable to Most Infectious Viruses • REVDx - 501 (REVID Œ ) is a diagnostic device in development for the detection of respiratory viral infection (SARS - CoV - 2, influenza A and B, parainfluenza, etc.) • REVDx - 501 detects IP - 10, a key cytokine that is upregulated in nasal and oral secretions at the onset of respiratory viral infection • Easy to use and understand kit that can be deployed anywhere ▪ Lateral flow format (similar to a pregnancy test kit) ▪ No equipment required to read ▪ Sample collected by simple swab of the lower portion of the nostril (nares) • Inexpensive and easy to manufacture • Rapid point - of - care (POC) results: <15 minutes ▪ Allows for repeated or daily testing • Kit design minimizes assignment of false negative: ▪ Results corelate well with PCR for COVID - 19 (100% positive agreement for replicating virus) • 510(k) submission planned for 1H 2022 Overview • Test Line (red): If present, indicates viral infection • Sample Control Line (navy blue): demonstrates sample properly collected • Assay Control Line (red): demonstrates device works The REVID Œ Device • REVTx - 99 • REVTx - 200 • REVDx - 501 26
A Universal Screening Tool Current Testing Paradigm • REVID Rapid Screen allows for testing of large bodies of people because test: ▪ Works regardless of virus type and any viral variants ▪ Is rapid ▪ Is inexpensive REVID Œ Rapid Screen REVID Rapid Screen will allow large numbers of people to be screened regardless of type of virus • Current testing for respiratory viral infection does not allow for testing of large bodies of people effectively because testing is: ▪ Specific ▪ Slow ▪ Expensive All Comers All Comers All Comers No Virus All Comers • REVTx - 99 • REVTx - 200 • REVDx - 501 27
Market Need: REVDx - 501 has Multiple Possible Uses with Potentially Large Markets 28 The simplicity of the kit will allow individuals to make informed decisions on their general health and whether to quarantine or go about daily life Individual Screening Tool Potential Target Population General population The simplicity and rapidity of the test kit allows for the screening of large numbers of people efficiently Institutional Screening Tool Potential Target Population Businesses with large crowds or at - risk individuals x Sports/concert arenas x Airports x Nursing homes x Hospitals 28 REVID Œ Rapid Screen can make more efficient usage of PCR testing by screening out those who do not have an infection up front Pre - PCR Screening Tool Potential Target Population Health care facilities 28 • REVTx - 99 • REVTx - 200 • REVDx - 501
Excellent Correlation between REVID Œ and PCR for COVID COVID PCR Positive (N=37) COVID PCR Negative (N=153) REVID Positive 37 21 REVID Negative 0 132 • The results from the REVID Test Kit are in good agreement with PCR ▪ 0% false negative rate for replicating SARS - CoV - 2 virus ▪ 14% false positive rate attributed to symptomatic subjects who had infection with a virus other than SARS - CoV - 2 (e.g. rhinovirus infection) Assay Performance False Negative Rate 0% False Positive Rate 14% • Samples were collected from symptomatic and asymptomatic subjects ▪ Symptomatic subjects included those presenting with fever, cough, loss of taste or loss of smell ▪ Samples were tested by PCR and using the REVID test kit • REVTx - 99 • REVTx - 200 • REVDx - 501 29
Management Leadership and Board of Directors
Board – R&D Leadership, Therapeutic & Diagnostic Development, Commercialization, Finance and Transactional Success George Tidmarsh M.D., Ph.D. Chairman M.D. and Ph.D. from Stanford University. Currently Adjunct Faculty of Pediatrics and Neonatology. Over 30 years of experience in biotechnology, including the successful clinical development of 7 FDA - approved drugs. CEO Secretary and a Director of La Jolla Pharmaceutical, Founder and Chief Executive Officer of Horizon Pharma, Threshold Pharmaceuticals. Jennifer Carver Director Over 19 years of industry experience. Formerly Chief Operating Officer at Kartos Therapeutics, Chief Operating Officer at La Jolla Pharmaceutical Company development, approval and launch of GIAPREZA. Spectrum Pharmaceuticals and Allos Therapeutics, leading teams through the development and approval of Belionostat and Folotyn respectively. Jess Roper C.P.A. Director Over 20 years of financial and audit experience in the sectors of medical device, life sciences, technology, manufacturing, and financial institutions. Currently serves as a Board Member and Audit Chair for Biolase. Senior Vice President and Chief Financial Officer of Dexcom; PricewaterhouseCoopers. Curt LaBelle M.D. Director Over 20 years of industry experience. President of the Global Health Investment Fund (GHIF). M.D. and M.B.A from Columbia University. 31
Management has a Strong History Building Successful Commercial Organizations (e.g., 3 NASDAQ and 1 NYSE Listings) James Rolke Director and Chief Executive Officer Over 30 years of experience in the biotechnology industry. Chief Scientific Officer of La Jolla Pharmaceutical Company, development of multiple technologies including 6 INDs and 2 marketing approvals. Chief Technology Officer at Pluromed, Inc. (acquired by Sanofi) approvals of two medical devices via the 510K and PMA approval pathways. Chester Zygmont, III Chief Financial Officer Over 17 years of experience in finance. Interim CFO and Senior Director of Finance, at La Jolla Pharmaceutical Company. During Mr. Zygmont’s tenure at La Jolla, he brought the company to its NASDAQ listing. While at La Jolla it grew from a market cap of $2.5 million to over $875 million, with trading volume increasing from $2,500 to over $15 million per day. Robin Marsden Vice President, Biology Over 25 years of experience in biotechnology, which has included executing the successful bioanalytical and immunogenicity strategy supporting three FDA - approved products: Symlin and Byetta and Giapreza Carol Odle Vice President, Clinical Ops Over 30 years of industry experience working for clinical sites, CROs and a Pharmaceutical Company on numerous indications. Site experience includes Executive Director and part owner of a clinical research site. Sandra Vedrick Vice President, Human Resources and Investor Relations For the 6 years prior to joining Revelation, Ms. Vedrick was Senior Director and Head of Investor Relations and Human Resources at La Jolla Pharmaceutical Company Picture to be updated Picture to be updated 32
Key Takeaways 33 Revelation Portfolio Scientific Rationale Near Term Value Drivers Experienced Management and Scientific Team
Transaction Overview
Revelation Biosciences, Inc. to go public through a SPAC merger with Petra Acquisition, Inc. (PAIC) 35 • PAIC is a healthcare - focused Special Purpose Acquisition Company (“SPAC”) that raised approximately $74 million in its IPO in Oc tober 2020, with its common stock trading on NASDAQ under the symbol PAIC • PAIC to acquire Revelation Biosciences for stock consideration valued at $105,000,000 • After the closing of the transaction, the combined company may have up to approximately $70 1 million in pro forma cash to fund operations (assuming no redemptions), with a potential additional $84 million in proceeds from cash warrants outstanding at a strike price of $11. 50 1 ▪ Net proceeds are primarily expected to fund clinical development of the company’s therapeutic and diagnostic candidates, incl udi ng: – advancing REVTx - 99 through its Phase 2 viral challenge study and further development needs; – Initiating Phase 1 clinical study of REVTx - 99 for the treatment of chronic nasal congestion; and – Continuing development of REVDx - 501 Revelation’s diagnostic for the detection of viral infections ▪ Expected to provide runway into Q2 2023 • The combined company is to be led by the existing Revelation leadership, including experienced executives in the life science s s ector • Revelation is expected to trade on the Nasdaq under the ticker “REVB” at closing • The transaction is expected to close in Q4 2021 Transaction Highlights 1 Pro forma cash balance calculated as sum of Revelation’s projected ending Q3 cash balance of $5.2M plus cash delivered from P AIC trust, assuming no redemptions from the trust, less assumed transaction expenses of $8.5M. $ 65 million in trust, net of estimated transaction expenses, would only be available assuming no redemptions from the Petra trust fu nd occur. However, since the Merger Agreement requires no minimum level of funding within the closing date Petra trust fund, there can be no assurances that $65 million in net proceeds will remain in the trust fund upon closing of the merger. See – “Forward - Looking Statements” on page 3 of this Presentation.
36 Sources and Uses Sources Amount ($M) Cash From PAIC Trust (1) $73.5 Revelation Equity Rollover $105.0 PAIC Sponsor Equity $18.4 Total Sources $196.9 Uses Amount ($M) Revelation Equity Rollover $105.0 PAIC Sponsor Equity $18.4 Net Cash to Revelation BS (1)* $65.0 Assumed Transaction Expenses (2) $8.5 Total Uses $196.9 (1) Assumes no redemptions from PAIC trust. (2) Includes certain advisory fees that may be paid in equity in lieu of cash. (3) Excludes 7.3M public PAIC warrants which are exercisable on a cash basis with a strike price of $11.50, and 3.2M private PAIC warrants which are exercisable on a cashless basis with a strike price of $11.50. (4) Pro form a c ash balance calculated as sum of Revelation’s projected ending Q3 cash balance of $5.2M plus cash delivered from PAIC trust, assuming no redemptions from the trust, less assumed transaction expenses of $8.5M. *How eve r, since the Merger Agreement requires $5,000,001 minimum level of funding within the closing date Petra trust fund, there can be no assurances that $65 million will remain in the trust fund upon closing of the mer ger. See – “Forward - Looking Statements” on page 3 of this Presentation. Pro Forma Valuation Particulars Amount Assumed Share Price $10.10 Pro Forma Shares Outstanding (1)(3) 19.6 Pro Forma Equity Value $197.9 Less: Pro Forma Cash (4)* $70.2 Pro Forma Enterprise Value $127.7 53.6% 37.1% 9.3% Pro Forma Ownership Revelation Shareholders Petra Public Shareholders Petra Sponsor Transaction Overview
Beneficial Holders
Revelation Beneficial Holders Significant Beneficial holders Percent pre - merger 1 Dr. George Tidmarsh (Chairman) 17.5% Company Management 30.7% AXA IM Prime Impact Fund 2 16.5% LifeSci Venture Partners 9.4% Monashee Investments 7.9% Total 64.5% 1. Fully diluted basis 2. Series A preferred stock as converted 38
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