Revelation Biosciences Inc - Using cutting edge science to develop innovative therapeutics and diagnostics
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Revelation Biosciences Inc. Using cutting edge science to develop innovative therapeutics and diagnostics January 2021
Forward Looking Statements
This presentation is being provided by Revelation Biosciences Inc., a Delaware corporation ("Revelation”). The information provided in this
presentation is the confidential and proprietary information of Revelation and is provided for informational purposes only. The information
provided in this presentation is provided on an “as is” basis. Revelation makes no representation or warranty, express or implied, with respect
to any information provided in this presentation, and will not be liable in any way to you or to any other person for any inaccuracy, error,
or omission of any information provided herein.
This presentation contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. We caution
investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this presentation and
involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks
and uncertainties include, but are not limited to: risks relating to the successful development of REVTx-99, REVTx-200, and REVDx-501; the
timing for the filing of an Investigational New Drug Application; the timing, costs, conduct, and outcome of clinical study (or studies); the
availability of emergency use authorization (“EUA”) and whether REVDx-501 would qualify for EUA; our ability to achieve the project
milestones; the timing and cost to achieve the project milestones; potential indication for which our drug candidates may be developed;
market potential and patient population; potential timeline to commercialization; and the expected duration over which Revelation's cash
balances will fund its operations. Forward-looking statements in this presentation apply only as of the date made, and we undertake
no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.
Mission Statement We develop immunologic therapeutics and diagnostics designed to make the world a healthier place 3
Experienced Management Experienced Successful track A history of building Management has management and record in multiple successful commercial broad experience in scientific team startups and turn- organizations financings and investor arounds including relations Extensive product Approval and development experience commercialization of drugs Experience with equity and 3 NASDAQ listings and 1 across multiple indications (e.g. GIAPREZA™) other types of financings NYSE listing spanning all stages of drug development including 8 Manufacturing scale up and Executive management of FDA and EMA approvals validation, development of companies that raised over sales force, regulatory path and $1 billion in multiple compliance financings 2021 Corporate Presentation I 4
Pipeline: Broadly Applicable to Most Infectious Viruses Therapeutics REVTx-99 • Lead Indication: Intranasal immunomodulator for the early treatment of SARS-CoV-2 infection − Phase 1 underway, cohort dosing ongoing − Safety and biomarker readout expected in Q1 2021 • Expanded Indications: REVTx-99 is also being developed for other indications targeting early treatment and prevention of respiratory viral infection such as with SARS-CoV-2, influenza A or B, parainfluenza and respiratory syncytial virus (RSV) − Viral Challenge study with influenza expected to start mid-2021 REVTx-200 • Intranasal immunomodulator adjunct to intramuscular (IM) vaccination using same platform as REVTx-99 Diagnostics REVDx-501 • Rapid, inexpensive, point-of-care diagnostic that is designed to detect any respiratory viral infection, regardless of virus type or strain without the need for specialized instrumentation 2021 Corporate Presentation I 5
Project Milestones, Timing, and Cash Through Q4 2021 Project Milestone Estimated Timing • Last study participant last visit cohort 5 Jan 2021 • Phase 1 clinical Proof-of-Principle Data Q1 2021 REVTx-99 • Initiate Phase 1/2 study in COVID-19 Patients Apr 2021 • Top-line data for Phase 1/2 COVID-19 study Dec 2021 • Start Phase 2 Viral Challenge study Jun 2021 REVTx-99 Expanded Indications • Phase 2 Viral Challenge Study Data Dec 2021 REVTx-200 • Partner asset Q1-Q2 2021 • File Emergency Use Authorization Application Jan 2021 REVDx-501 • Identify development and commercialization partner Q1-Q2 2021 • $9.1 million equity financing closed Dec 30, 2020 o Current cash takes us through Q4 2021 2021 Corporate Presentation I 6
Revelation Product Candidates May be Eligible for Expedited FDA Approval • FDA has issued criteria for Emergency Use Authorization (EUA) • REVTx-99 and REVDx-501 may be eligible for EUA following completion of a single study • Phase 1/2 Study Planned for first half of 2021 2021 Corporate Presentation I 7
REVTx-99 Intranasal PHAD® for the early treatment of COVID-19
REVTx-99 Overview and Proof-of-Principle • REVTx-99 is in development for the early treatment of SARS-CoV-2, and is broadly applicable to most infectious viruses including SARS-CoV-2 variants • Phosphorylated hexaacylated disaccharide (PHAD®) is synthetically manufactured in GMP form • Proof-of-principle for treatment of COVID-19 - SARS-CoV-2 viral proteins block innate immune signaling pathway, decreasing interferon production leading to more severe infection1 - Interferons inhibit SARS-CoV-2 replication in vitro2 - Exogenous interferons have been shown to be effective in vivo vs. SARS-CoV-2 infection2,3,4,5,6,7,8 - Intranasal REVTx-99 stimulates the production of multiple, local interferons as well as other protective cytokines via TLR4 agonism9 - Therefore REVTx-99 will likely ameliorate COVID-19 in humans • Phase 1 underway, cohort dosing ongoing • Phase 1/2 study in early COVID-19 patients expected to begin in 1H 2021 • Potentially Rapid Regulatory Path via Emergency Use Authorization10 1 PLoS ONE Volume 7, Number 2, February 1, 2012, doi.org/10.1371/journal.pone.0030802 6 Gao, et al., 2010 Vaccine Volume 28, April 2010, pp. 4445–4451 doi:10.1016/j.vaccine.2010.03.062 2 Journal of Biological Chemistry June 25, 2020 DOI: 10.1074/jbc.AC120.013788 7 Monk, et al., 2020, Lancet Respiratory Med, November 12, 2020, https://doi.org/10.1016/ S2213-2600(20)30511-7 3 Lokugamage 2020. DOI: https://doi.org/10.1101/2020.03.07.982264 8 Channappanavar, 2016, Cell Host & Microbe 19, 181–193, February 10, 2016 4 Meng et al 2020. https://doi.org/10.1101/2020.04.11.20061473 9 PLoS ONE Volume 7, Number 7, July 19, 2012 doi:10.1371/journal.pone.0041144 5 Hayden, et al., 1984, The Journal of Infectious Diseases, Volume 150, Number 2, pp. 174-180 10 Doran Fink, December 10, 2020, Emergency Use Authorization, USFDA Presentation 2021 Corporate Presentation I 9
REVTx-99 Chemistry and Manufacture Active Pharmaceutical Ingredient • Phophorylated hexaacylated disaccharide (PHAD®) is the active ingredient in REVTx-99 • PHAD is synthetic and manufactured in GMP form • Adequate supply to support development through Phase 2 purchased • Low-cost API Drug Product • Simple formulation for Phase 1 testing to be delivered as nasal drops • Drug is prepared for Phase 1 by compounding pharmacy • Additional formulation work ongoing 2021 Corporate Presentation I 10
REVTx-99 Active Pharmaceutical Ingredient (API) Acts to Stimulate Interferon Production via TLR4 Stimulation • Stimulation of TLR4 can activate two distinct pathways − MYD88 – leads to production of inflammatory cytokines − TRIF – leads to production of interferons and adaptive immune response • REVTx-99 API acts by stimulating TLR4 and preferentially activates the TRIF pathway Weak Induction of Strong induction of proinflammatory cytokines protective cytokines including IL-6 including interferons 2021 Corporate Presentation I 11
Interferon Anti-Viral Mechanism of Action • IFNs have potent antiviral effects and are the first line of defense against viral infections (SARS-CoV-2, influenza A and B, parainfluenza, etc.) • IFNs bind to cell surface receptors and activate the transcription of hundreds of genes • IFN-induced gene expression protects cells from viral invasion • REVTx-99 works by stimulating the endogenous production of Interferons (IFNs) and other protective cytokines via agonism of TLR-4 and preferential activation of the TRIF pathway • REVTx-99 should be effective against SARS-CoV-2, SARS-CoV-2 variants and broadly applicable to other infectious viruses such as influenza, parainfluenza, etc Nature Reviews Immunology, Volume 5, May 2005, pp. 375-386 doi:10.1038/nri1604 2021 Corporate Presentation I 12
Interferon and SARS-CoV-2 infection • A proportional deficiency and/or deactivation in Type I and III interferons has been observed for patients with increasingly severe COVID-19 symptoms1,2,3 • This decrease in IFN disrupts normal recognition and signaling of viral invasion and appears to allow for unchecked viral replication • Multiple nonclinical studies have demonstrated IFN as effective in preventing or reducing proliferation of SARS-CoV-24,5 • Administration (4x/day) of IFN-a2 to hospital workers in Hubei province during outbreak resulted in zero confirmed cases of COVID-196 • Clinical intranasal administration of IFN-a2 results reduced7 and prevented viral infection8 • Administration of inhaled IFN-β to COVID-19 patients resulted in greater odds of improvement and more rapid recovery from SARS-CoV-2 infection9 • Early treatment with interferon was effective at reducing SARS-CoV-2 infection10 1. Blanco-Melo et al., 2020, Cell 181:1-10. https://doi.org/10.1016/j.cell.2020.04.026 6. Meng et al 2020. https://DOI.org/10.1101/2020.04.11.20061473 2. J. Hadjadj et al., 2020 Science DOI 10.1126/science.abc6027 (2020) 7. Hayden, et al., 1984, The Journal of Infectious Diseases, Volume 150, Number 2, pp. 174-180 3. Trouillet-Assant 2020 J Allergy Clin Immunol 146 1:206-208, Letter to the editor 8. Gao, et al., 2010 Vaccine Volume 28, April 2010, pp. 4445–4451 doi:10.1016/j.vaccine.2010.03.062 4. Felgenhauer et al, 2020 Journal of Biological Chemistry DOI: 10.1074/jbc.AC120.013788 9. Monk, et al., 2020, Lancet Respiratory Med, November 12, 2020, https://doi.org/10.1016/ S2213-2600(20)30511-7 5. Lokugamage 2020. DOI: https://doi.org/10.1101/2020.03.07.982264 10. Channappanavar, 2016, Cell Host & Microbe 19, 181–193, February 10, 2016 2021 Corporate Presentation I 13
Early Interferon Treatment Ameliorates SARS-CoV Infection • Delayed Type I IFN response results in dysregulated immune response and severe disease • Early treatment with IFN ameliorates SARS-CoV pathology • Further supported by data for T-Covid which upregulates innate immune system protecting against viral challenge (ALT:Nasdaq) “Exogenous IFN-I delivered prior to peak virus titers abrogates this cascade of events and ameliorates immuno- pathological disease....” IFN delivered intranasally post infection Cell Host & Microbe 19, 181–193, February 10, 2016 WHO, Business Insider; April 20, 2020. 2021 Corporate Presentation I 14
Clinical Studies Have Shown that Intranasal IFN- 2 Prevents Viral Infections • This Proof-of-Concept study supports the hypothesis that stimulation of endogenous IFNs would be clinically beneficial for multiple types of respiratory infection Virus Placebo Group Infection Rate (%) IFN- 2 Group Infection Rate(%) Relative Risk (95% CI) Influenza A 22.6 6.4 0.236 (0.153-0.363) Influenza B 15.8 4.3 0.238 (0.164-0.388) Parainfluenza A 15.9 4.1 0.226 (0.139-0.368) Adenovirus 7.2 3.1 0.406 (0.165-0.999) Respiratory Syncytial Virus 2.8 0.8 0.279 (0.057-1.356) • Nasal spray of IFN- 2 or placebo twice daily for 5 days while at risk for infection • Significant reduction in infection with influenza A and B as well as parainfluenza • Mild side effects include throat dryness (16% placebo v 27% IFN- 2) and nose bleeds (3.6% placebo v 4.6% IFN- 2) Vaccine Volume 28, April 2010, pp. 4445–4451 doi:10.1016/j.vaccine.2010.03.062 2021 Corporate Presentation I 15
Summary of Proof-of-Principle for REVTx-99 for Treatment of COVID-19 • SARS-CoV-2 viral proteins block innate immune signaling pathway, decreasing interferon production leading to more severe infection • Interferons inhibit SARS-CoV-2 replication in vitro • Exogenous interferons have been shown to be effective in vivo vs. SARS-CoV and SARS-CoV- 2 infection • Intranasal REVTx-99 stimulates the production of multiple, local interferons as well as other protective cytokines via TLR4 agonism • Therefore REVTx-99 will likely be an effective treatment for SARS-CoV-2, SARS-CoV-2 variants, and broadly applicable to most infectious viruses such as influenza, parainfluenza, etc 2021 Corporate Presentation I 16
RVL-HV01: Phase 1 Health Volunteer Study – Single Ascending Dose Study Title RVL-HV01: A Phase 1, Placebo-Controlled, Single Dose, Escalating Dose Study to Determine the Safety and Tolerability of Intranasal REVTx-99 in Healthy Adult Volunteers in Australia Study Endpoints • Primary: 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: 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: a) Plasma PK levels Study Design • Total number of subjects: 40 • 5 cohorts, 8 per cohort (6 treated and 2 placebo). Each treated group will receive a dose of either 5, 15, 30, 50 or 100 µg • Readouts: Safety measurements, systemic and nasal cytokine levels, systemic pK Status and Timing • Study approved by Ethics Committee in Australia • Cohort dosing ongoing • Expected top-line data: Q1 2021 2021 Corporate Presentation I 17
REVTx-99 Expanded Indications Overview • REVTx-99 may have applications beyond early treatment of COVID-19, as such Revelation intends to pursue: – Early treatment of other respiratory viral infections such as those caused by viruses like influenza A and B, parainfluenza, and RSV – Prevention of respiratory viral infection in at-risk populations such as health care workers, the elderly, and immunocompromised patients • Product rationale - Published preclinical studies have shown PHAD can substantially prevent death following a lethal challenge of influenza virus - Published clinical studies have shown that intranasal IFNs can prevent or reduce the severity of respiratory viral infection • A viral challenge study in patients with H1N1 or H5N1 is expected to be initiated in mid-2021 - REVTx-99 will be given either prophylactically or post-viral challenge 2021 Corporate Presentation I 18
Market Need and Competition
Market Need: REVTx-99 Broadly Applicable to Most Infectious Viruses • According to the US CDC, between 5 and 20% of people living in the US contract influenza each year – with a total economic cost that exceeds $87 billion. • A third wave of COVID-19 cases is currently accelerating worldwide. Physicians and public health workers are concerned about the superimposition of this third wave on top of seasonal spikes in RSV and influenza cases. • New variants of SARS-CoV-2 have emerged and may escape vaccination and current experimental therapies. Current vaccines against COVID-19 may not be effective against SARS-CoV-2 variants Tamiflu sales were $277 million in 1H 2019 despite strong generic competition and modest effectiveness Baloxavir (XofluzaTM) sales expected to reach $204 million per year in the US by 2024 Morgan Stanley Research; April 15, 2020. 2021 Corporate Presentation I 20
REVTx-99 Potentially Effective Regardless of Viral Strain • New strains of SARS-CoV-2 have emerged in several countries “The South African variant is very concerning right now because it does appear to obviate some of our medical countermeasures, particularly the antibody drugs.” – Dr. Scott Gottlieb, January 5, 2021 • Monoclonal antibody therapeutics are engineered to target short protein sequences • Alterations to these sequences through mutation can prevent the antibody from recognizing the pathogen, rendering the antibody therapeutic less effective or ineffective • Site E484 is contained within the receptor binding domain of the SARS-CoV-2 spike protein, where the virus docks onto ACEII receptors, and is key to effective antibody neutralization1 • Mutation at site E484 has been observed for SARS-CoV-2, which may significantly reduce efficacy of therapeutic antibodies – There is a possibility these mutations may also attenuate native polyclonal antibody immunity elicited by infection or vaccination • Through the upregulation of interferons, REVTx-99 is potentially broadly effective against viral infection, regardless of viral type or strain, or potential mutation 1 - Comprehensive mapping of mutations to the SARS-CoV-2 receptor-binding domain that affect recognition by polyclonal human serum antibodies, Greaney, et.al. 2020 2021 Corporate Presentation I 21
REVTx-99:Distinct Mechanism of Action with Low Cost and Convenient Delivery Admin in Tx Name Company ROA MOA Est Rx cost/Tx 1 Status clinic/home REVTx-99 Revelation Biosciences Intranasal Innate immune system activation $50-$100 Home Phase 1 REGN-CoV2 Regeneron Infusion Neutralization of SARS-CoV-2 spike proteins $10,000 2 Clinic EUA Approval Bamlanivimab Eli Lilly Infusion Neutralization of SARS-CoV-2 spike proteins $10,000 2 Clinic EUA Approval AdCOVID Altimmune Intranasal Induction of Interferons $250-$500 3 Home PhI/II T-COVID Altimmune Intranasal Induction of Interferons $250-$500 3 Home PhI PUL-042 Pulmotect Inhalation Innate immune system activationn Cannot determine Home PhII Poly I:C multiple including PrEP, Janssen Inhalation Induction of Interferons Cannot determine Home Ph1 EC-18 Enzychem Lifesciences (South Korea) Oral Anti-inflammatory Cannot determine Home PhII M5046/MK-4482/EIDD-2801 Merck, Germany Oral Anti-inflammatory Cannot determine Home PhII/III Imiquimod 3M TBD Innate immune system activation Cannot determine TBD Preclinical darunavir Janssen Oral Protease inhibitor $500-1000 Home P3 dexamethasone Multiple IM, Oral, SC, IV, IO, eye drop Anti-inflammatory inexpensive Home Approved galidesivir Bio cryst IV infusion Inhibits viral replication Cannot determine Clinic P1 ivermectin Wellona Pharma Oral Blocks viral entry Cannot determine Home P1/P2 lopinavir/ritonavir (Kaletra) AbbVie Oral (solution, tablet) Inhibits viral replication $500-1000 Home P2/P2B/P3 remdesivir (Veklury) Gilead Sciences IV infusion (oral tablet in development) Inhibits viral replication $3,000 Clinic EUA in US triazavirin Russian Academy of Sciences Oral Inhibits viral replication Cannot determine Home P1 1 - Costs are estimated per single full course of treatment under normal conditions (non-Emergency status) 2 - Global Journal on Quality and Safety in Healthcare, average cost of MAb therapy at $3200 per infusion 3 - Based on Altimmune NasoShield price target being half of NasoThrax (Emergent Biosolutions) 2020 Corporate Presentation I 22
Summary of REVTx-99 • REVTx-99 is in development for the early treatment of SARS-CoV-2, and is broadly applicable to most infectious viruses including SARS-CoV-2 variants • Well understood mechanism of action for inducing endogenous protective cytokines including interferons • Strong rationale for the treatment of COVID-19 – Proof of principle animal studies demonstrating interferon β treatment of SARS-CoV infection • Phase 1 biomarker study approved – Cohort dosing ongoing • Phase 1/2 COVID-19 study planned to start mid-2021 • Additional indications including prevention of respiratory viral infections – Strong proof of concept in animal studies preventing systemic influenza infection • Well controlled GMP synthetic manufacturing process established • Rapid approval for COVID-19 possible via Emergency Use Authorization • Large market need and well differentiated product (low cost, easy to use, at home delivery) 2021 Corporate Presentation I 23
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 formulations and methods have been filed • Development Rationale – IM vaccination results in a strong systemic immune response imparting systemic immunity, but a weak mucosal immune response – Contrary to this, intranasal vaccination (e.g. FluMist®) has been shown to illicit a strong mucosal response and a moderate systemic response – REVTx-200 API has been shown to stimulate the innate and adaptive immune system when given intranasally • Identify and work with multiple partners with existing vaccines to evaluate REVTx-200 during 2021 • Initial clinical studies will likely be viral challenge in nature, post immunization 2021 Corporate Presentation I 25
REVDx-501 Rapid testing kit for viral infection
REVDx-501: Broadly Applicable to Most Infectious Viruses • REVDx-501 is a diagnostic device in development for the detection of respiratory viral infection (SARS-CoV-2, influenza A and B, parainfluenza, etc.) • REVDx-501 can be used: − To allow for SARS-CoV-2 tests to be more efficiently used by screening out negative patients − As a triage tool to categorize subjects: e.g. normal activity, further testing, or continued quarantine • Development rationale: − Multiple studies have demonstrated nasal and oral secretion of multiple cytokines at the onset of wide range of respiratory viral infections − These cytokines are detectable via ELISA testing which can be translated into a lateral flow assay format • Status: − Provisional patent for assay and device has been filed − LFA methods: 3 different cytokines have been established with low pg/mL sensitivity and excellent correlation to ELISA results. These cytokines can be tested together in one test or separately. − On track to submit Emergency Use Authorization (EUA) application in Q1 2021 − Results exceed threshold for FDA approval 2021 Corporate Presentation I 27
REVDx-501 vs. Current EUA PCR Tests in SARS-CoV-2 Variants • FDA has issued a statement warning of the heightened ability of False Negative test results from SARS-CoV-2 variants on current PCR tests • Accuracy can suffer from changes in specific areas of the virus’s genome • REVDx-501 detects the innate immune response to any type of virus and should not be affected by variants fda.gov, January 8, 2021 2021 Corporate Presentation I 28
Improving SARS-CoV-2 Testing • Current COVID-19 screening includes all patients including those that are virus negative • REVDx-501 Rapid Screen allows for virus negative patients to be eliminated, thus increasing the efficiency of SARS-CoV-2 specific testing No Screening REVDx-501 Rapid Screen Reported positive rate 9-15% Applies to all All Comers All Comers respiratory viruses High negative test rate wastes Earlier detection resources means earlier isolation Virus Influenza Possible increase SARS CoV-2 Negative Negative to 50-60% test positive rate SARS CoV- Influenza SARS-CoV-2 2 Negative Positive Increase SARS SARS-CoV-2 Virus Negative CoV-2 testing Positive availability 5-6x 2021 Corporate Presentation I 29
Nasal Secretion of Cytokines Correlates with Viral Shedding Nasal Influenza Virus Titer (TCID50 /ml) • Healthy volunteers challenged with influenza H1N1 • Nasal secretion of cytokines correlated with viral shedding at day 2 − Additional timepoints with modern reagents before day 2 to Study Day confirm full correlation • Other cytokine concentrations also correlated out to day 6 IL-6 Nasal Lavage Cytokine Concentration (pg/ml) • Analysis of multiple cytokines will improve sensitivity and decrease false positive rate Study Day The Journal of Clinical Investigation Volume 101, Number 3, February 1998, 643–649 doi.org/10.1172/JCI1355. 2021 Corporate Presentation I 30
Conceptual Lateral Flow Assay Readout Detection of a positive sample. Subject is infected and may be spreading virus. 1st Cytokine 2nd Cytokine Assay Band Band Controls Detection of a negative sample. Subject is not infected or spreading virus. 1st Cytokine 2nd Cytokine Assay Band Band Controls 2021 Corporate Presentation I 31
Correlation between REVDx-501 and PCR PCR vs. REVDx-501 Test Kit PCR POSITIVE PCR NEGATIVE Test Kit Positive 22 9 Test Kit Negative 2 35 TOTAL SAMPLES 24 44 • REVDx-501 is highly predictive of SARS-CoV-2 infection ü Positive Percent Agreement = 91.7 ü Negative Percent Agreement = 79.5 (excess positives likely represent other viral infections) ü Results exceed threshold for FDA EUA approval 2021 Corporate Presentation I 32
REVDx-501: Current Status Update • Good progress has been made on the REVDx-501 project to date – LFA methods with excellent sensitivity (low pg/mL) have been established for 3 cytokine (10, 25 and ~150 pg/mL respectively) – Clinical samples demonstrate a high degree of correlation between REVDx-501 and PCR for COVID Positive and negative patients – Additional clinical samples to be analyzed to further define error rates • Preparing to file and obtain Emergency Use Authorization (EUA) to allow for field testing 2021 Corporate Presentation I 33
Market Need: REVDx-501 Broadly Applicable to Most Infectious Viruses • 35.5 million Americans contract influenza each year • 42 million COVID-19 cases and 1.1 million deaths from COVID-19 have been reported to the WHO as of Oct 25, 2020 • RSV infection is responsible for 57,000 hospitalizations in young children in the US each year. The US CDC estimates that 177,000 hospitalizations and 14,000 deaths occur New cases of COVID-19 per day in the United States, March 1, 2020 through October 13, 2020. Source: NY Times, 10/15/20. among US adults each year due to RSV infection. • A diagnostic test to discriminate between viral and bacterial infection could help reduce over-prescribing of antibiotics We are headed in the wrong direction, and that’s reflected not only in the number of new cases but also in test positivity and the number of hospitalizations. Caitlin Rivers, PhD Rockefeller Bloomberg School Foundation COVID-19 of Public National Testing & Tracing Action Plan Health Number of COVID-19 cases reported weekly by WHO Region and global deaths, Dec 30, 2019 through October 25, 2020. Source: WHO, 10/28/20. 2021 Corporate Presentation I 34
Summary
Pipeline: Broadly Applicable to Most Infectious Viruses Therapeutics REVTx-99 • Lead Indication: Intranasal immunomodulator for the early treatment of SARS-CoV-2 infection − Phase 1 underway, cohort dosing ongoing − Safety and biomarker readout expected in Q1 2021 • Expanded Indications: REVTx-99 is also being developed for other indications targeting early treatment and prevention of respiratory viral infection such as with SARS-CoV-2, influenza A or B, parainfluenza and respiratory syncytial virus (RSV) − Viral Challenge study with influenza expected to start mid-2021 REVTx-200 • Intranasal immunomodulator adjunct to intramuscular (IM) vaccination using same platform as REVTx-99 Diagnostics REVDx-501 • Rapid, inexpensive, point-of-care diagnostic that is designed to detect any respiratory viral infections regardless of virus type without the need for specialized instrumentation 2021 Corporate Presentation I 36
Project Milestones, Timing, and Cash Through Q4 2021 Project Milestone Estimated Timing • Last study participant last visit cohort 5 Jan 2021 • Phase 1 clinical Proof-of-Principle Data Q1 2021 REVTx-99 • Initiate Phase 1/2 study in COVID-19 Patients Apr 2021 • Top-line data for Phase 1/2 COVID-19 study Dec 2021 • Start Phase 2 Viral Challenge study Jun 2021 REVTx-99 Expanded Indications • Phase 2 Viral Challenge Study Data Dec 2021 REVTx-200 • Partner asset Q1-Q2 2021 • File Emergency Use Authorization Application Jan 2021 REVDx-501 • Identify development and commercialization partner Q1-Q2 2021 • $9.1 million equity financing closed Dec 30, 2020 o Current cash takes us through Q4 2021 2021 Corporate Presentation I 37
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