What changed in this filing

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Item 1. Business

2025-03-06 compared with 2024-03-22 · 107 added, 114 removed, 528 unchanged (30% of the section changed)

Revelation is a clinical-stage biopharmaceutical company founded in May 2020.

We are focused on the development or commercialization of innate immune system therapeutics and diagnostics.

On January 10, 2022, we consummated our previously announced Business Combination.

Prior to the Business Combination, Petra was a blank check company incorporated under the laws of Delaware for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, or similar business combination with one or more businesses.

In connection with the consummation of the Business Combination, Petra changed its name to Revelation Biosciences, Inc.

Our common stock and Public Warrants are listed on Nasdaq under the ticker symbol “REVB” and “REVBW,” respectively.

Revelation is a clinical-stage life science company that is focused on rebalancing inflammation to optimize health using its proprietary formulation Gemini.

We have multiple ongoing programs to evaluate Gemini, including GEM-AKI as a prevention for acute kidney injury (“AKI”), GEM-CKD as a treatment for chronic kidney disease (“CKD”), and GEM-PSI as a prevention for post surgical infection (“PSI”).

The Company was incorporated in the state of Delaware on November 20, 2019 (originally as Petra Acquisition, Inc.) and is based in San Diego, California.

Our common stock and warrants sold in our initial public offering (“Public Warrants”) are listed on The Nasdaq Stock Market, LLC (“Nasdaq”) under the ticker symbol “REVB” and “REVBW,” respectively.

Recent Developments

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On January 17, 2025, at a special meeting of stockholders, our stockholders approved a Certificate of Amendment to our Third Amended and Restated Certificate of Incorporation to effect a reverse stock split of our outstanding shares of common stock at a specific ratio within a range of one-for-two (1-for-2) to a maximum of a one-for-fifty (1-for-50) split.

Following the special meeting of stockholders and determination by the Board of Directors on the reverse split ratio, we filed a Certificate of Amendment effective on January 28, 2025, which effected a 1-for-16 reverse stock split of our outstanding shares of common stock as of 12:01 a.m.

Eastern Standard Time on January 28, 2025.

2024 Reverse Stock Split

On January 17, 2024, at a special meeting of stockholders, our stockholders approved a Certificate of Amendment to our Third Amended and Restated Certificate of Incorporation to effect a reverse stock split of our outstanding shares of common stock at a specific ratio within a range of one-for-two (1-for-2) to a maximum of a one-for-fifty (1-for-50) split.

On January 22, 2024, we filed the Certificate of Amendment which effected a 1-for-30 reverse stock split of our outstanding shares of common stock as of 12:01 a.m.

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Revelation is developing a pipeline of potential high-value products based on Gemini.

Gemini is Revelation’s proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD ® ) an established TLR4 agonist that can stimulate the human body’s innate immune response to prevent and treat disease.

The product candidates being developed by Revelation are based on our proprietary Gemini formulation of PHAD.

Gemini is Revelation’s proprietary formulation of phosphorylated hexaacyl disaccharide (“PHAD ® ”) an established Toll-like receptor 4 (TLR4”) agonist that can stimulate the human body’s innate immune response to prevent and treat disease.

Our current Gemini based programs consist of:

Gemini-SSI, which is being developed for the prevention of surgical site infection (SSI);

Gemini-AKI, which is being developed for the prevention of acute kidney injury (AKI);

and Gemini-CKD for the treatment of chronic kidney disease (CKD).

Gemini-AKI, which is being developed for the prevention of AKI;

Gemini-CKD for the treatment of CKD;

and Gemini-PSI, which is being developed for the prevention of PSI.

Revelation’s pipeline is summarized in the figure below:

Preclinical and Phase 1 data will be used to support SSI and AKI indications.

The Therapeutic Platform

Our current therapeutic candidates are all based on our proprietary Gemini formulation of PHAD ® , a synthetic version of MPLA, that is known to stimulate TLR4.

Stimulation of TLR4 via Gemini leads to a more controlled production of varied cytokines and chemokines which modulate the activity of the innate and adaptive immune response, relative to LPS, a traditional TLR4 agonist.

This “Immunostimulatory Preconditioning” with Gemini prepares the body to better guard against a rapid upregulation of multiple pro-inflammatory and microbial gene products and proteins, such as PAMPS (pathogen-associated molecular patterns) and DAMPS (damage-associated molecular proteins) (Zwirner 2017, Hernandez 2019, Ismaeli 2002).

The Gemini Platform

Our current therapeutic candidates are all based on our proprietary Gemini formulation of PHAD ® , a synthetic version of monophosphoryl lipid A (“MPLA”), that is known to stimulate TLR4.

This “Immunostimulatory Preconditioning” with Gemini prepares the body to better guard against a rapid upregulation of multiple pro-inflammatory and microbial gene products and proteins, such as pathogen-associated molecular patterns (“PAMPS”) and damage-associated molecular patterns (“DAMPS”) (damage-associated molecular proteins) (Zwirner 2017, Hernandez 2019, Ismaeli 2002).

Modulated activities may include stimulation and recruitment of infection fighting immune cells, reduction of inflammation, and/or regulation of inflammation depending on the degree and nature of the stimulation, which enables the multiple potential product candidates in development.

Interaction of PHAD with TLR4

The Gemini-SSI program is being developed, through a license agreement with Vanderbilt University, as a potential therapy for the prevention or treatment of surgical site infection.

We believe immunologic preconditioning with Gemini prepares the body to resist infection by priming the body’s immune system to better and more rapidly respond to pathogen exposure.

Multiple preclinical studies have shown that systemic pretreatment with PHAD results in a significantly augmented immune response leading to significantly reduced duration and severity of infection following bacterial challenge with either gram-positive or gram-negative bacteria.

Phase 1 safety and biomarker activity data is expected in the summer of 2024.

The Gemini-AKI program is being developed as a potential therapy for the prevention of acute kidney injury (AKI) due to external stress or insult (e.g.

The Gemini-AKI program is being developed as a potential therapy for the prevention of AKI due to external stress or insult (e.g.

surgical procedure, chemotherapy toxicity).

We believe immunologic preconditioning with Gemini prepares the body to handle biologic stress by redirecting the body’s immune system to have an attenuated response to the stress.

Nonclinical studies have demonstrated that preconditioning with PHAD significantly reduces the severity and duration of AKI following an ischemia of the kidney.

Additional data from these nonclinical studies have been accepted for presentation at The International Conference on Advances in Critical Care Nephrology on March 12, 2024.

Phase 1 safety and biomarker activity data is expected in the summer of 2024.

The Gemini-CKD program is being developed as a potential therapy for preventing the progression of chronic kidney disease (CKD).

Preclinical studies have demonstrated that preconditioning with PHAD significantly reduces the severity and duration of AKI following an ischemia of the kidney.

Additional data from these preclinical studies have been accepted for presentation at The International Conference on Advances in Critical Care Nephrology on March 12, 2024.

During 2024 we conducted a Phase 1 clinical study.

safety and biomarker activity data from our Phase 1 clinical study was announced in June of 2024, showing a significant increase in anti-inflammatory cytokines including IL-1RA and IL-10.

In January of 2025 we announced the start of our Phase 1b clinical study in CKD patients.

The Phase 1b clinical study will support further development of Gemini-AKI.

We expect data from our Phase 1b clinic study in the first half of this year.

The Gemini-CKD program is being developed as a potential therapy for preventing the progression of CKD.

We believe Gemini may modulate the immune response from a pro-inflammatory state to an anti-inflammatory (protective) state to rebalance the innate immune response and slow down or halt the progressive destruction and scarring of organ tissue, allowing the healing process to take place.

Nonclinical studies have demonstrated that Gemini significantly reduces the degree of scar tissue formation in a hyperinflammatory kidney injury model.

Revelation plans to conduct additional nonclinical CKD studies in 2024 to optimize the dose and dosing regimen for Gemini in this indication.

Preclinical studies have demonstrated that Gemini significantly reduces the degree of scar tissue formation in a hyperinflammatory kidney injury model.

In January of 2025 we announced the start of our Phase 1b clinical study in CKD patients.

The Phase 1b clinical study will support further development of Gemini-CKD.

We expect data from our Phase 1b clinic study in the first half of this year.

The Gemini-PSI program is being developed, through a license agreement with Vanderbilt University, as a potential therapy for the prevention or treatment of surgical site infection.

We believe immunologic preconditioning with Gemini prepares the body to resist infection by priming the body’s immune system to better and more rapidly respond to pathogen exposure.

Our goal is to become a leading biopharmaceutical company focused on the development of therapeutics that modulate the immune system to prevent and treat conditions with significant unmet needs.

The key components of our strategy are to:

• Advance the development of Gemini for the prevention and treatment of surgical site infection

• Advance the development of Gemini for the prevention of acute kidney injury

• Advance the development of Gemini for the treatment of chronic kidney disease

• Advance the development of Gemini for the prevention and treatment of post surgical infection

Our Corporate History and Team

Revelation Biosciences, Inc.

was formed on May 4, 2020 and is a Delaware corporation.

The Company was incorporated in the state of Delaware on November 20, 2019 (originally as Petra Acquisition, Inc.) and is based in San Diego, California.

We have assembled a management team of biopharmaceutical experts with extensive experience in drug development, manufacturing and commercialization of pharmaceutical products along with broad experience in building companies from inception, including La Jolla Pharmaceutical Company, Pluromed, Inc., and Horizon Pharma, Inc.

We are also supported by a group of directors and leading investors whose collective experience will assist us in realizing our corporate strategy.

Surgical Site Infection Overview

Despite efforts to monitor and prevent infection in hospital care settings, Infections arise from a range of different causes including surgery, burn wounds, central line catheters or urinary catheters, and sepsis, as well as long courses of antibiotic treatment, which may lead to the development of MRSA.

According to the most recent prevalence study data published by the Center for Disease Control and Prevention in 2015, approximately 3% of hospital patients suffered at least one infection, and there were approximately 687,000 infection cases in acute care settings resulting in approximately 72,000 deaths.

According to the CDC, on any given day about 31 hospital patients has at least one healthcare-associated infection.

A World Health Organization cooperative study which included 55 hospitals in 14 countries from four regions, approximately 8.7% of hospitalized patients developed infection within 48 hours of hospitalization (Tikhomirov 1987).

The most common healthcare-associated infections are bloodstream infection, pneumonia, urinary tract infections, and surgical site infections.

Acute Kidney Injury Overview

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Alternatively, ischemia may be the unintentional result of an untoward complication such as intraoperative hypotension.

Regardless of etiology, the ischemic event initially leaves the affected area(s) deprived of blood, oxygen, and other nutrients which then can exacerbate to injury when the blood supply returns to the site along with reactive oxygen species (ROS) and other constituents that cause oxidative stress to the tissues.

Regardless of etiology, the ischemic event initially leaves the affected area(s) deprived of blood, oxygen, and other nutrients which then can exacerbate to injury when the blood supply returns to the site along with reactive oxygen species and other constituents that cause oxidative stress to the tissues.

There are no approved therapies for preventing AKI, including AKI due to cardiac surgery.

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Organ disease (due to chronic inflammation and subsequent fibrosis, for example) is progressive and ultimately results in loss of function of the organ.

Examples of chronic organ and tissue disease include CKD through end-stage renal disease, liver diseases such as NASH, osteoarthritis, rheumatoid arthritis, pulmonary fibrotic disease, heart disease, pancreatitis, cancer, and irritable bowel syndrome.

Examples of chronic organ and tissue disease include CKD through end-stage renal disease, liver diseases such as non-alcoholic steatohepatitis, osteoarthritis, rheumatoid arthritis, pulmonary fibrotic disease, heart disease, pancreatitis, cancer, and irritable bowel syndrome.

Kidney disease is a major public health problem, affecting ~10% of populations in industrialized countries.

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Every day more than 360 people begin treatment for kidney failure (dialysis or transplant).

According to the CDC, more than 1 in 7, that is 15%, of US adults or 37 million people are estimated to have CKD.

According to the Centers for Disease Control and Prevention (the “CDC”), more than 1 in 7, that is 15%, of US adults or 37 million people are estimated to have CKD.

As many as 9 to 10 adults with CKD as well as about 2 in 5 adults with severe CKD do not know they have the disease.

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The CDC estimates Medicare costs in excess of $87 billion and continues to promote reduced costs including better management of CKD.

Post Surgical Infection Overview

Despite efforts to monitor and prevent infection in hospital care settings, infections arise from a range of different causes including surgery, burn wounds, central line catheters or urinary catheters, and sepsis, as well as long courses of antibiotic treatment, which may lead to the development of methicillin-resistant Staphylococcus aureus resistant infection (“MRSA”).

According to the CDC, on any given day about 31 hospital patients has at least one healthcare-associated infection.

The most common healthcare-associated infections are bloodstream infection, pneumonia, urinary tract infections, and surgical site infections.

Current Prevention, Treatment, and Detection Options

Prevention of Surgical Site Infection

There are no approved therapies currently available for the prevention of infection outside of pre- and post-surgical administration of antibiotics and commonly recommended procedures for the preventing the transmission of bacteria including hand washing, mask wearing, and cleaning the surgical site pre- and post-surgery.

In the case of antibiotic pretreatment, the typical course of treatment may require an initial empiric broad-spectrum antibiotic, later targeted to an organism if detected, with consideration for the presence of multidrug resistant pathogens, specifically MRSA.

Antibiotic resistance has become a major consideration in the need for pretreatment of yet-to-be diagnosed infections, as the number of antibiotic resistant strains have increased, and the over prescription of antibiotics further contributes to resistance.

Prevention and Treatment of AKI

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Still, at this time, there is a significant unmet need for therapies that slow disease progression and improve outcomes of patients with chronic kidney disease.

Prevention of Post Surgical Infection

REVELATION’S PROGRAMS

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Cytokines are proteins that direct different activities in cells and can be inflammatory or protective, meaning they may be able to modulate certain established cellular activities.

TLRs serve a vital role in initiating the innate immune system response by recognizing different molecular patterns associated with pathogens such as bacteria and viruses (e.g.

Toll-like receptors serve a vital role in initiating the innate immune system response by recognizing different molecular patterns associated with pathogens such as bacteria and viruses (e.g.

pathogen associated molecular patterns) as well as tissue damage (e.g.

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Revelation Biosciences

Gemini-SSI Program

Gemini is being evaluated as a potential therapy for the prevention or treatment of surgical site infection.

We believe immunologic preconditioning with Gemini prepares the body to resist infection by priming the body’s immune system to respond to pathogen exposure more rapidly.

In addition to surgical site infection, we believe Gemini may also have utility for post-burn infection, urinary tract infection (e.g.

as a result of hospital-based or outpatient catheterization), sepsis, and antibiotic-resistant infection.

Revelation is developing Gemini for the prevention of infection through a license agreement with Vanderbilt University.

Nonclinical studies

Multiple preclinical studies have shown that pretreatment with PHAD results in significantly augmented immune response with significantly reduced duration and severity of infection following bacterial challenge with either gram-positive or gram-negative bacteria as indicated in the following figures.

Pretreatment with PHAD Impart Protection from Gram Negative Bacterial Infection

Pretreatment with PHADs Impart Protection from Gram Positive Bacterial Infection

Clinical Development Plan

Phase 1 safety and biomarker activity data is expected in the summer of 2024.

The Phase 1 study will be followed by a Phase 1b study in patients undergoing colorectal surgery to evaluate safety and efficacy in this patient population.

Gemini-AKI Program

Gemini is being evaluated as a potential therapy for the prevention of acute kidney injury (AKI) due to external stress (e.g.

Gemini is being evaluated as a potential therapy for the prevention of AKI due to external stress (e.g.

surgical procedure, chemotherapy toxicity).

We believe immunologic preconditioning with Gemini prepares the body to handle biologic stress by directing the body’s immune system to have an attenuated response to the stress.

Gemini is being evaluated as a potential therapy for the prevention of acute kidney injury (AKI).

Gemini is being evaluated as a potential therapy for the prevention of AKI.

Preclinical studies have shown that pretreatment with PHAD results in significantly decreased severity and duration of acute kidney injury due to ischemia.

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Clinical Development Plan

Phase 1 safety and biomarker activity data is expected in the summer of 2024.

The Phase 1 study will be followed by a Phase 1b study in patients undergoing cardiac surgery to establish dose and dosing regimen in preparation for Phase 2.

The proposed Phase 1b study will consist of a placebo group and low and high dose Gemini groups.

During 2024 we conducted a Phase 1 clinical study.

Subsequently, safety and biomarker activity data from our Phase 1 clinical study was announced in June of 2024, showing a significant increase in anti-inflammatory cytokines including IL-1RA and IL-10.

In January of 2025 we announced the start of our Phase 1b clinical study in CKD patients.

The Phase 1b clinical study will support further development of Gemini-AKI.

We expect data from our Phase 1b clinic study in the first half of this year.

The Phase 1b study in CKD patients will be followed by a Phase 1b study in patients undergoing cardiac surgery to establish dose and dosing regimen in preparation for Phase 2.

The primary readout will be safety with exploratory endpoints to evaluate biomarkers and rate, duration, and severity of AKI.

Gemini-CKD Program

Gemini is being evaluated as a potential therapy for preventing the progression of chronic kidney disease (CKD).

Gemini is being evaluated as a potential therapy for preventing the progression of CKD.

Revelation conducted a nonclinical study to evaluate the potential of Gemini to prevent kidney fibrosis due to excess inflammation.

Specifically, a range of daily systemic dosing levels of Gemini were tested in a rat Unilateral Ureteral Obstruction (UUO) model.

The unilateral ureteral obstruction (UUO) model is appropriate for studying the anti-inflammatory and anti-fibrotic effects of potential new therapies for acute and chronic kidney disease as complete ureteral obstruction of one kidney results in significant inflammation and subsequent fibrosis of the obstructed kidney over a 7-day period.

The present study consisted of 6 groups with the following outcomes on renal cortical fibrosis as measured by detection of collagen deposition using picosirius red stained histology sections assessed at three different sampling depths.

Specifically, a range of daily systemic dosing levels of Gemini were tested in a rat unilateral urethral obstruction (“UUO”) model.

The UUO model is appropriate for studying the anti-inflammatory and anti-fibrotic effects of potential new therapies for acute and chronic kidney disease as complete ureteral obstruction of one kidney results in significant inflammation and subsequent fibrosis of the obstructed kidney over a 7-day period.

The present study consisted of 6 groups with the following outcomes on renal cortical fibrosis as measured by detection of collagen deposition using picrosirius red stained histology sections assessed at three different sampling depths.

Gemini Treatment Reduces Fibrosis in Acute and Chronic Kidney Model (UUO in Rats)

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TGF-β is pro-fibrotic and is directly linked to the propagation of fibrosis.

The positive control (PC) is an established TGF-β blocker.

The positive control is an established TGF-β blocker.

IL-10 is a key driver for the reduction and resolution of inflammation, and NGAL is an important defense for preventing excessive oxidative damage resulting from injury/ongoing inflammation.

Development Plan

During 2024, Revelation will continue evaluating the potential of Gemini in additional preclinical models of CKD to identify optimal dosing conditions and conduct the nonclinical testing required for chronic dosing in patients.

In January of 2025 we announced the start of our Phase 1b clinical study in CKD patients.

The Phase 1b clinical study will support further development of Gemini-AKI.

We expect data from our Phase 1b clinic study in the first half of this year.

Revelation will continue evaluating the potential of Gemini in additional preclinical models of CKD to identify optimal dosing conditions and conduct the preclinical testing required for chronic dosing in patients.

Gemini-PSI Program

Gemini is being evaluated as a potential therapy for the prevention or treatment of post surgical infection.

We believe immunologic preconditioning with Gemini prepares the body to resist infection by priming the body’s immune system to respond to pathogen exposure more rapidly.

In addition to post surgical infection, we believe Gemini may also have utility for post-burn infection, urinary tract infection (e.g.

as a result of hospital-based or outpatient catheterization), sepsis, and antibiotic-resistant infection.

Revelation is developing Gemini for the prevention of infection through a license agreement with Vanderbilt University.

Preclinical studies

Pretreatment with PHAD Impart Protection from Gram Negative Bacterial Infection

Pretreatment with PHADs Impart Protection from Gram Positive Bacterial Infection

Clinical Development Plan

During 2024 we conducted a Phase 1 clinical study.

We are evaluating the next steps to be taken in the development of Gemini-PSI.

The biopharmaceutical industry is intensely competitive and subject to rapid innovation and significant technological advancements.

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Given the high incidence of AKI and CKD, and the rate of surgical site infections, it is likely that the number of companies seeking to develop products and therapies for the prevention or treatment of such, will increase.

If Gemini-SSI is approved for prevention of surgical site infection, we would face competition from currently approved and marketed products including many antibiotics that are effective against non-resistant strains of bacteria.

We would also have future competition that could arise from products currently in development.

If Gemini-AKI is approved for prevention of acute kidney injury, we would face competition that could arise from products currently in development.

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We would also have future competition that could arise from products currently in development.

If Gemini-PSI is approved for prevention of surgical site infection, we would face competition from currently approved and marketed products including many antibiotics that are effective against non-resistant strains of bacteria.

We would also have future competition that could arise from products currently in development.

Many of our competitors have substantially greater financial, technical, human, and other resources than we do and may be better equipped to develop, manufacture, and market technologically superior products.

Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of competitors.

In addition, many of these competitors have significantly longer operating histories and greater experience than we have in undertaking nonclinical studies and human clinical studies of new pharmaceutical products and in obtaining regulatory approvals of human therapeutic products.

In addition, many of these competitors have significantly longer operating histories and greater experience than we have in undertaking preclinical studies and human clinical studies of new pharmaceutical products and in obtaining regulatory approvals of human therapeutic products.

Many of our competitors have established distribution channels for the commercialization of their products, whereas we have no such channel or capabilities.

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The license grants Revelation the use of issued US patent 11,389,465.

We are obligated to use commercially reasonable efforts to (i) develop, commercialize, market and sell licensed products in a manner consistent with a development plan submitted to Vanderbilt by April 2023 and (ii) achieve certain financing, development, regulatory and clinical milestone events, including, among other things, raising $5 million in financing to advance the development program, commencement of various clinical trials by target dates according to the development plan and the filing of an IND by the end of 2032.

Under the license agreement we are obligated to make payments to Vanderbilt based upon achievement of certain milestones including achievement of various clinical trial events, regulatory approval and sales levels.

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We also rely on trade secret protection of our confidential information and know-how relating to our proprietary technology, platforms, and product candidates.

As of March 18, 2024, our patent portfolio includes one U.S.

provisional patent application directed to methods of treating cancer using MPLA formulations, including GEMINI.

We expect to convert this provisional application to a utility patent application prior to its 1-year anniversary.

Our portfolio also includes two patent families, each of which has been filed in the U.S., Canada, and Europe.

One of these patent families is directed to MPLA formulations, including GEMINI;

the other patent family is directed to the use of GEMINI for the treatment of allergic rhinitis and chronic nasal congestion.

Regarding our GEMINI AKI and GEMINI CKD programs, our portfolio also includes a PCT application directed to the use of MPLA formulations for the prevention of loss of function associated with acute organ disease and chronic organ disease.

Our portfolio additionally includes a PCT application directed to methods of using MPLA formulations, including GEMINI, as an adjuvant to traditional allergy immunotherapy, such as oral allergy immunotherapy.

Finally, we have licensed from Vanderbilt University a patent directed to methods of using phosphorylated hexaacyl disaccharides (PHADs) for treating or preventing infections.

We expect to file a non-provisional patent application prior to the twelve-month convention date for each provisional patent application.

As of March 3, 2025, our patent portfolio includes one patent family directed to MPLA formulations, including Gemini.

This patent family includes one U.S.

application, one European Patent Organization (“EPO”) application, and one Canadian application.

Our portfolio additionally includes a Patent Cooperation Treaty (“PCT”) application directed to methods of using MPLA formulations, including Gemini, as an adjuvant to traditional allergy immunotherapy, such as oral allergy immunotherapy.

Regarding our GEM-AKI and GEM-CKD programs, our portfolio also includes a patent family directed to the use of MPLA formulations for the prevention of loss of function associated with acute organ disease and chronic organ disease.

This patent family includes one application in the U.S., as well as applications filed in the EPO, China, Japan, South Korea, and Canada.

Finally, we have licensed from Vanderbilt University a patent directed to methods of using PHAD for treating or preventing infections.

Our pending and future patent applications may not result in patents being issued which protect our technology or product candidates, or which effectively prevent others from commercializing competitive technologies and product candidates.

Additionally, any U.S.

provisional patent application that we file is not eligible to become an issued patent until, among other things, we file a non-provisional patent application within 12 months of filing the related provisional patent application.

If we do not file a non-provisional patent application in a timely manner, we may lose our priority date with respect to the provisional patent application, and may lose the ability to obtain any associated patent protection on the inventions disclosed in the provisional patent application.

Generally, issued patents are granted a term of 20 years from the earliest claimed non-provisional filing date.

In certain instances, patent term can be adjusted to recapture a portion of delay incurred by the USPTO in examining the patent application (patent term adjustment, or PTA) or extended to account for term effectively lost as a result of the FDA regulatory review period (patent term extension, or PTE), or both.

In certain instances, patent term can be adjusted to recapture a portion of delay incurred by the U.S.

Patent and Trademark Office (the “USPTO”) in examining the patent application (patent term adjustment, or “PTA”) or extended to account for term effectively lost as a result of the FDA regulatory review period (patent term extension, or “PTE”), or both.

In addition, we cannot provide any assurance that any patents will be issued from our pending or future applications or that any issued patents will adequately protect our products or product candidates.

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We consider our relationship with our employees to be good.

Legal Proceedings

On February 18, 2022, LifeSci Capital LLC filed an action against the Company in the U.S.

District Court for the Southern District of New York seeking damages in the amount of approximately $5.3 million plus interest for unpaid banking and advisory fees.

These fees arise under contracts which were entered into prior to the Business Combination and the Company has asserted that LifeSci Capital LLC is not entitled to the fee because it violated its responsibilities by misrepresenting to Petra the funds that would be available following the Business Combination, absent which Petra would not have entered into the Business Combination Agreement.

This action remains pending as of the date of this report.

$1.5 million of the claim relates to deferred underwriting commissions from the Petra initial public offering, which are recorded as a current liability in the financial statements as of September 30, 2022 under deferred underwriting commissions.

On December 1, 2023 a Magistrate Judge issued a report recommending summary judgment in favor of LifeSci Capital LLC.

On December 15, 2023, the Company filed objections to the Magistrate’s report asserting that the Magistrate Judge made factual determinations not appropriate for summary judgment and misapplied the law.

The Magistrate’s report is a recommendation to the trial judge who is responsible for reviewing the case de novo.

Other than the deferred underwriting commissions, no liabilities are reflected in the financial statements as the amount of any additional liability cannot be determined at this time.

On September 27, 2022, A-IR Clinical Research Ltd.

(“A-IR”) filed a claim against the Company in the High Court of Justice, in the Business and Property Courts of England and Wales, seeking £1.6 million in unpaid invoices, plus interest and costs, relating to the Company’s viral challenge study.

The Company is disputing the claim because many of the invoices relate to work that was not performed and A-IR had misrepresented its qualifications to perform the contracted work.

Since this proceeding is at a very early stage, no liability is reflected in the financial statements as the amount of any liability cannot be determined at this time.

Government Regulation

The FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, recordkeeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs.

We, along with our vendors, contract research organizations, or CROs, clinical investigators and contract manufacturing organizations, or CMOs will be required to navigate the various preclinical, clinical, manufacturing and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval of our product candidates.

We, along with our vendors, contract research organizations (“CROs”), clinical investigators and contract manufacturing organizations (“CMOs”) will be required to navigate the various preclinical, clinical, manufacturing and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval of our product candidates.

The process of obtaining regulatory approvals of drugs and ensuring subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources.

In the United States, the FDA regulates drug products under the FD&C Act, its implementing regulations, and other federal, state and local statutes and regulations.

In the United States, the FDA regulates drug products under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), its implementing regulations, and other federal, state and local statutes and regulations.

Drugs are also subject to other federal, state and local statutes and regulations.

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Our product candidates must be approved for therapeutic indications by the FDA before they may be marketed in the United States.

For drug product candidates regulated under the FD&C Act, FDA must approve a NDA.

For drug product candidates regulated under the FD&C Act, FDA must approve a New Drug Application (“NDA”).

The process generally involves the following:

• completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with good laboratory practice, or GLP, requirements;

• completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with good laboratory practice (“GLP”) requirements;

• completion of the manufacture, under current Good Manufacturing Practices (“cGMP”), conditions, of the drug substance and drug product that the sponsor intends to use in human clinical trials along with required analytical and stability testing;

• submission to the FDA of an investigational new drug application, or IND, which must become effective before clinical trials may begin and must be updated annually and when certain changes are made;

• approval by an institutional review board, or IRB, or independent ethics committee at each clinical trial site before each trial may be initiated;

• performance of adequate and well-controlled clinical trials in accordance with applicable IND regulations, good clinical practice, or GCP, requirements and other clinical trial-related regulations to establish the safety and efficacy of the investigational product for each proposed indication;

• approval by an institutional review board (“IRB”), or independent ethics committee at each clinical trial site before each trial may be initiated;

• performance of adequate and well-controlled clinical trials in accordance with applicable IND regulations, good clinical practice (“GCP”), requirements and other clinical trial-related regulations to establish the safety and efficacy of the investigational product for each proposed indication;

• preparation and submission to the FDA of an NDA;

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For clinical studies involving an IND, an IRB must operate in compliance with FDA regulations.

Additionally, some studies are overseen by an independent group of qualified experts organized by the study sponsor, known as a DSMB.

Additionally, some studies are overseen by an independent group of qualified experts organized by the study sponsor, known as a data safety monitoring board (“DSMB”).

This group provides authorization as to whether or not a study may move forward at designated check points based on access that only the DSMB maintains to available data from the study.

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Healthcare Laws and Compliance Requirements

In the United States, our current and future operations are subject to regulation by various federal, state and local authorities in addition to the FDA, including but not limited to, the CMS, other divisions of the HHS (such as the Office of Inspector General, Office for Civil Rights and the Health Resources and Service Administration), the U.S.

In the United States, our current and future operations are subject to regulation by various federal, state and local authorities in addition to the FDA, including but not limited to, the Centers for Medicare & Medicaid Services (“CMS”), other divisions of the U.S.

Department of Health and Human Services (“HHS”) (such as the Office of Inspector General, Office for Civil Rights and the Health Resources and Service Administration), the U.S.

Department of Justice, and state and local governments.

For example, our clinical research, sales, marketing and scientific/educational grant programs may have to comply with the anti-fraud and abuse provisions of the Social Security Act, the false claims laws, the privacy and security provisions of HIPAA, and similar state laws, each as amended, as applicable.

For example, our clinical research, sales, marketing and scientific/educational grant programs may have to comply with the anti-fraud and abuse provisions of the Social Security Act, the false claims laws, the privacy and security provisions of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), and similar state laws, each as amended, as applicable.

The federal Anti-Kickback Statute prohibits, among other things, any person or entity from knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any item or service reimbursable, in whole or in part, under Medicare, Medicaid or other federal healthcare programs.

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Additionally, the intent standard under the Anti-Kickback Statute was amended by the Affordable Care Act, to a stricter standard such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

In addition, the Affordable Care Act also codified case law that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal FCA (discussed below).

The federal false claims and civil monetary penalty laws, including the FCA, which imposes significant penalties and can be enforced by private citizens through civil qui tam actions, prohibit any person or entity from, among other things, knowingly presenting, or causing to be presented, a false or fraudulent claim for payment to, or approval by, the federal government, including federal healthcare programs, such as Medicare and Medicaid;

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Penalties may apply in some cases when such metrics are not submitted accurately and timely.

Additionally, the Sunshine Act within the Affordable Care Act, and its implementing regulations, require that certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) report annually to CMS information related to certain payments or other transfers of value made or distributed to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals and to report annually certain ownership and investment interests held by physicians and their immediate family members.

Additionally, the Physician Payment Sunshine Act (the “Sunshine Act”) within the Affordable Care Act, and its implementing regulations, require that certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) report annually to CMS information related to certain payments or other transfers of value made or distributed to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals and to report annually certain ownership and investment interests held by physicians and their immediate family members.

This information is made publicly available on a CMS website, and failure to report accurately could result in penalties.

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We expect additional state, federal and foreign healthcare reform measures to be adopted in the future, any of which could limit the amounts that federal, state and foreign governments will pay for health products, which could result in reduced demand for our products, if approved or additional pricing pressure.

For instance, in December 2021, the EU Regulation No 2021/2282 on Health Technology Assessment, or HTA, amending Directive 2011/24/EU, was adopted.

For instance, in December 2021, the European Union (“EU”) Regulation No 2021/2282 on Health Technology Assessment, or HTA, amending Directive 2011/24/EU, was adopted.

While the Regulation entered into force in January 2022, it will only begin to apply from January 2025 onwards, with preparatory and implementation-related steps to take place in the interim.

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The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements.

Under the FDASIA, the FDA has additional authority to take action against manufacturers not adhering to pediatric study requirements.

Under the Food and Drug Administration Safety and Innovation Act, the FDA has additional authority to take action against manufacturers not adhering to pediatric study requirements.

Unless otherwise required by regulation, the pediatric data requirements do not apply to products with orphan drug designation.

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Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

Drugs listed in the Orange Book can, in turn, be cited by potential competitors in support of approval of an ANDA.

Drugs listed in the Orange Book can, in turn, be cited by potential competitors in support of approval of an abbreviated new drug application (“ANDA”).

Generally, an ANDA provides for marketing of a drug product that has the same active ingredients in the same strengths and dosage form as the listed drug and has been shown through bioequivalence testing to be therapeutically equivalent to the listed drug.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business