ONCR Oncorus Inc.

15.75
-1.12  -7%
Previous Close 16.87
Open 17
52 Week Low 11.5
52 Week High 37.8603
Market Cap $403,611,689
Shares 25,626,139
Float 17,309,587
Enterprise Value $305,886,101
Volume 197,857
Av. Daily Volume 147,133
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Latest News

  1. -- Renowned academic and industry leader brings deep expertise in oncology translational research and drug development, including pioneering work at Merck on KEYTRUDA® (pembrolizumab) --

    CAMBRIDGE, Mass., June 17, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation viral immunotherapies to transform outcomes for cancer patients, today announced the appointment of Eric Rubin, M.D. to its Board of Directors. Dr. Rubin brings to Oncorus an expansive 30-year academic and industry career in cancer drug development, including his oncology leadership roles at Merck, known as MSD outside of the United States and Canada, where he currently serves as Senior Vice President of Global…

    -- Renowned academic and industry leader brings deep expertise in oncology translational research and drug development, including pioneering work at Merck on KEYTRUDA® (pembrolizumab) --

    CAMBRIDGE, Mass., June 17, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation viral immunotherapies to transform outcomes for cancer patients, today announced the appointment of Eric Rubin, M.D. to its Board of Directors. Dr. Rubin brings to Oncorus an expansive 30-year academic and industry career in cancer drug development, including his oncology leadership roles at Merck, known as MSD outside of the United States and Canada, where he currently serves as Senior Vice President of Global Clinical Oncology. As previously announced, the terms of Robert Kirkman, M.D. and Cameron Wheeler, Ph.D. as members of Oncorus' Board of Directors ended upon the conclusion of the company's annual meeting of stockholders held on June 16, 2021.

    "We are thrilled to welcome Eric to our Board as we progress our pipeline of viral immunotherapies engineered for systemic activity," said Theodore (Ted) Ashburn, M.D., Ph.D., President and CEO of Oncorus. "We look forward to the initial readout later this year from our ongoing Phase 1 clinical study of ONCR-177, our lead oncolytic Herpes Simplex Virus (oHSV) candidate, and we are continuing to advance our recently nominated novel Synthetic viral RNA (vRNA) Immunotherapy candidates toward the clinic. Eric's contributions to the oncology field, including his pioneering work at Merck in immuno-oncology, has truly helped transform the care of cancer patients. We look forward to his insights and guidance as we work with urgency to realize the full potential of viral immunotherapies for cancer patients."

    Dr. Ashburn continued, "On behalf of the entire Oncorus team, I would also like to extend my sincere gratitude to Bob and Cam for their service on and many contributions to our Board and our company."

    Oncorus is advancing a portfolio of intratumorally (iTu)- and intravenously (IV)-administered viral immunotherapies for multiple solid tumor indications with significant unmet needs based on its oHSV and Synthetic vRNA Immunotherapy Platforms. Oncorus is currently conducting a Phase 1 clinical trial of ONCR-177, an iTu-administered oHSV viral immunotherapy, for the treatment of solid tumors, both as a monotherapy and in combination with Merck's anti-PD-1-therapy, KEYTRUDA® (pembrolizumab). ONCR-177 uniquely retains the ability to avoid interferon challenge and is armed with five immune-modulatory payloads. With its lead IV-administered Synthetic vRNA Immunotherapy candidates, ONCR-021 and ONCR-788, Oncorus' pioneering IV-administered approach involves encapsulating the genomes of RNA viruses known to kill cancer cells (i.e., oncolytic viruses, or OVs) in a lipid nanoparticle, or LNP, creating a Synthetic vRNA Immunotherapy. ONCR-021 encodes an optimized strain of Coxsackievirus A21 (CVA21), and ONCR-788 encodes a modified version of the Seneca Valley Virus (SVV).

    "Despite the remarkable progress we've made against certain cancers, there is still a great deal of work ahead of us to help more cancer patients and save more lives," said Dr. Rubin. "Viral immunotherapies hold significant promise to be an important immuno-oncology tool that enables us to treat many types of cancer more effectively. However, their potential has been limited thus far by certain challenges. Oncorus has engineered highly innovative technologies into both of its platforms, which may enable the oncolytic virus modality to finally achieve its cancer-fighting and life-saving potential for patients. I look forward to collaborating with Ted and the Oncorus team on this important work."

    Beginning his oncology career in academia, Dr. Rubin served as a faculty member at the Dana-Farber Cancer Institute and then as a senior leader of the Cancer Institute of New Jersey, where he was Director of the Investigational Therapeutics Division. His research efforts focused on mechanisms of resistance to DNA topoisomerase-targeting drugs and his laboratory cloned TOPORS, a novel topoisomerase I- and p53-interacting tumor suppressor gene. In 2008, Dr. Rubin was recruited to Merck to lead the clinical oncology development team. Under his leadership, the clinical oncology group underwent a transformational change to realize the potential of cancer immunotherapy. He led the initial development of the anti-PD-1 antibody pembrolizumab (KEYTRUDA®), which was the first anti-PD-1 therapy approved in the U.S., and in the identification of the significant activity of this breakthrough therapeutic across several cancer types. In 2014, Dr. Rubin was asked to head up Oncology Early Development for Merck, and in this role he oversees development of a promising and expansive early pipeline, as well as translational oncology research activities.

    Dr. Rubin has authored over 100 original, peer-reviewed publications and book chapters related to oncology translational research, clinical trials, and drug development. He has served frequently as a member of National Cancer Institute and American Cancer Society study sections, as well as on program committees for the American Association of Cancer Research (AACR) and the American Society of Clinical Oncology. He is a co-chair of the Cancer Steering Committee of the Biomarkers Consortium, Foundation of the National Institute of Health, a member of the Science Policy and Governmental Affairs Committee for AACR, and was a member of the National Cancer Moonshot Initiative/Blue Ribbon Panel Working Group on Expanding Clinical Trials.

    Upcoming Synthetic vRNA Immunotherapy Investor Event

    Oncorus will host a virtual investor event on Monday, June 21, 2021 from 1:00 pm to 2:30 pm ET to discuss details surrounding its Synthetic vRNA Immunotherapy Platform and its lead Synthetic vRNA Immotherapy clinical candidates, ONCR-021 and ONCR-788. Leena Ghandi, M.D., Ph.D., Director, Center for Cancer Therapeutic Innovation at the Dana-Farber Cancer Institute, will be a featured speaker. For more information or to RSVP for the event, please contact Josh Rauch at .

    Click here to read a white paper published by Oncorus' leadership on the company's Synthetic vRNA Immunotherapy Platform and lead candidates, ONCR-021 and ONCR-788. Click here to read Oncorus' press release announcing its recent nomination of ONCR-021 and ONCR-788.

    About Oncorus

    At Oncorus, we are focused on driving innovation to deliver next-generation viral immunotherapies to transform outcomes for cancer patients. We are advancing a portfolio of intratumorally (iTu) and intravenously (IV) administered viral immunotherapies for multiple indications with significant unmet need based on our oncolytic Herpes Simplex Virus (oHSV) and Synthetic viral RNA (vRNA) Immunotherapy Platforms.

    Designed to deliver next-generation viral immunotherapy impact, our oHSV platform improves upon key characteristics of this therapeutic class to enhance systemic activity. Our lead oHSV program, ONCR-177, is designed to be directly administered into a tumor, resulting in high local concentrations of the therapeutic agent and its five encoded transgenes, as well as low systemic exposure to the therapy, which we believe could potentially limit systemic toxicities. Our pioneering Synthetic vRNA Immunotherapy Platform involves a highly innovative, novel combination of RNA- and oncolytic virus-based modalities to realize the potential of RNA medicines for cancer. Our lead IV-administered Synthetic vRNA clinical candidates, ONCR-021 and ONCR-788, are both currently in IND-enabling studies.

    Please visit www.oncorus.com to learn more.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the evolving immuno-oncology landscape, the potential of Oncorus' Synthetic vRNA Immunotherapy Platform; preclinical and clinical development of ONCR-021 and ONCR-788, including expectations regarding timelines for filing INDs, as well as the product candidates' therapeutic potential and clinical benefits, mechanism of action and the utility; and expectations regarding manufacturing capabilities, including the buildout timeline of Oncorus' viral immunotherapy clinical manufacturing facility. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on Oncorus' operations and the timing and anticipated results of its ongoing and planned clinical trials; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future clinical trials; Oncorus' ability to successfully demonstrate the safety and efficacy of ONCR-021 and ONCR-788; Oncorus' ability to secure adequate quantities of viral immunotherapies manufactured in accordance with regulatory requirements; the expansion of Oncorus' in-house manufacturing capabilities; the adequacy of Oncorus' cash resources and availability of financing on commercially reasonable terms; and Oncorus' ability to obtain, maintain and protect its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Oncorus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 10, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the other filings that Oncorus makes with the Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" page of the Investors section of Oncorus' website at http://investors.oncorus.com. Any forward-looking statements represent Oncorus' views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Oncorus explicitly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

    Investor Contact:Media Contact:
    Alan LadaLiz Melone
    Solebury Trout
    617-221-8006 
     

     



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    • Virtual event will take place on June 21, 2021 from 1:00 – 2:30 p.m. ET
    • Oncorus' novel approach leverages selectively self-amplifying vRNA encoding for oncolytic viruses encapsulated within lipid nanoparticles (LNPs)
    • Oncorus' leadership will discuss its Synthetic vRNA Platform and lead Synthetic vRNA candidates, ONCR-021 and ONCR-788, as well as its state-of-the-art process development and GMP manufacturing facility
    • Guest speaker: Leena Ghandi, M.D., Ph.D., Director, Center for Cancer Therapeutic Innovation at the Dana-Farber Cancer Institute

    CAMBRIDGE, Mass., June 15, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, today announced that…

    • Virtual event will take place on June 21, 2021 from 1:00 – 2:30 p.m. ET
    • Oncorus' novel approach leverages selectively self-amplifying vRNA encoding for oncolytic viruses encapsulated within lipid nanoparticles (LNPs)
    • Oncorus' leadership will discuss its Synthetic vRNA Platform and lead Synthetic vRNA candidates, ONCR-021 and ONCR-788, as well as its state-of-the-art process development and GMP manufacturing facility
    • Guest speaker: Leena Ghandi, M.D., Ph.D., Director, Center for Cancer Therapeutic Innovation at the Dana-Farber Cancer Institute

    CAMBRIDGE, Mass., June 15, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, today announced that it will host an upcoming investor day featuring its intravenous (IV)-administered Synthetic viral RNA (vRNA) Immunotherapy Platform, and its recently nominated lead Synthetic vRNA Immunotherapy product candidates, ONCR-021 and ONCR-788. The virtual event will take place on June 21, 2021 from 1:00 – 2:30 p.m. ET.

    Oncorus Synthetic vRNA Immunotherapies Day Agenda

    • Leena Ghandi, M.D., Ph.D., Director, Center for Cancer Therapeutic Innovation at the Dana-Farber Cancer Institute, will be a featured speaker at the event. Dr. Ghandi will review current clinical practice and the potential for IV-administered viral immunotherapies to address significant unmet needs.
    • Oncorus leadership will discuss the company's pioneering IV-administered approach, which involves encapsulating the genomes of RNA viruses known to kill cancer cells (i.e., oncolytic viruses, or OVs) within a lipid nanoparticle (or LNP), creating a Synthetic vRNA immunotherapy. Oncorus' novel Synthetic vRNA approach holds the potential for repeat IV administration and avoids the challenge of neutralizing antibodies seen in previous approaches with IV-administered, naturally-occurring OVs.
    • Oncorus will review preclinical data supporting the ONCR-021 and ONCR-788 candidate nominations and discuss current clinical development plans for each program. ONCR-021 encodes an optimized strain of Coxsackievirus A21 (CVA21), and ONCR-788 encodes a modified version of the Seneca Valley Virus (SVV).
    • Finally, the company will also provide an overview of its 88,000 square foot state-of-the-art process development and Good Manufacturing Practice (GMP) manufacturing facility in Andover, Mass., which it anticipates will be operational for GMP manufacturing in the first half of 2023.

    A live webcast of the event will be available to registered attendees under the Investors and Media section of Oncorus' website at https://investors.oncorus.com/events-and-presentations. A replay of the presentation will be archived on Oncorus' site for 60 days following the event.

    For more information or to RSVP, please contact Josh Rauch at .

    Click here to read a white paper published by Oncorus' leadership on it Synthetic vRNA Immunotherapy Platform and lead candidates.

    About Oncorus

    At Oncorus, we are focused on driving innovation to deliver next-generation viral immunotherapies to transform outcomes for cancer patients. We are advancing a portfolio of intratumorally (iTu) and intravenously (IV) administered viral immunotherapies for multiple indications with significant unmet need based on our oncolytic Herpes Simplex Virus (oHSV) and Synthetic viral RNA (vRNA) Immunotherapy Platforms.

    Designed to deliver next-generation viral immunotherapy impact, our oHSV platform improves upon key characteristics of this therapeutic class to enhance systemic activity. Our lead oHSV program, ONCR-177, is designed to be directly administered into a tumor, resulting in high local concentrations of the therapeutic agent and its five encoded transgenes, as well as low systemic exposure to the therapy, which could limit systemic toxicities. Our pioneering Synthetic vRNA Immunotherapy Platform involves a highly innovative, novel combination of RNA- and oncolytic virus-based modalities to realize the potential of RNA medicines for cancer. Our lead IV-administered Synthetic vRNA Immunotherapy clinical candidates, ONCR-021 and ONCR-788, are both currently in IND-enabling studies.

    Please visit www.oncorus.com to learn more.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the evolving immuno-oncology landscape, the potential of Oncorus' Synthetic vRNA Immunotherapy Platform; preclinical and clinical development of ONCR-021 and ONCR-788, including expectations regarding timelines for filing INDs, as well as the product candidates' therapeutic potential and clinical benefits, mechanism of action and the utility; and expectations regarding manufacturing capabilities including the buildout timeline of Oncorus' viral immunotherapy clinical manufacturing facility. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on Oncorus' operations and the timing and anticipated results of its ongoing and planned clinical trials; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future clinical trials; Oncorus' ability to successfully demonstrate the safety and efficacy of ONCR-021 and ONCR-788; Oncorus' ability to secure adequate quantities of viral immunotherapies manufactured in accordance with regulatory requirements; the expansion of Oncorus' in-house manufacturing capabilities; the adequacy of Oncorus' cash resources and availability of financing on commercially reasonable terms; and Oncorus' ability to obtain, maintain and protect its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Oncorus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 10, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the other filings that Oncorus makes with the Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" page of the Investors section of Oncorus' website at http://investors.oncorus.com. Any forward-looking statements represent Oncorus' views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Oncorus explicitly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

    Investor Contact:Media Contact:
    Alan LadaLiz Melone
    Solebury Trout
    617-221-8006 
     


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    • Pioneering Synthetic vRNA immunotherapies that are composed of self-amplifying vRNA encoding for oncolytic viruses encapsulated within lipid nanoparticles (LNPs)
    • Novel approach engineered to produce a living immunostimulatory drug in the form of infectious virions in the tumor to destroy cancer cells, and stimulate multiple arms of the immune system
    • Two candidates nominated: ONCR-021 encodes an optimized strain of Coxsackievirus A21 (CVA21), and ONCR-788 encodes a modified version of the Seneca Valley Virus (SVV)
    • In preclinical studies, Oncorus' IV-administered Synthetic vRNA demonstrated efficacy in multiple tumor models and avoided the challenge of neutralizing antibodies seen in previous approaches using IV-administered natural viruses
    • Oncorus…
    • Pioneering Synthetic vRNA immunotherapies that are composed of self-amplifying vRNA encoding for oncolytic viruses encapsulated within lipid nanoparticles (LNPs)
    • Novel approach engineered to produce a living immunostimulatory drug in the form of infectious virions in the tumor to destroy cancer cells, and stimulate multiple arms of the immune system
    • Two candidates nominated: ONCR-021 encodes an optimized strain of Coxsackievirus A21 (CVA21), and ONCR-788 encodes a modified version of the Seneca Valley Virus (SVV)
    • In preclinical studies, Oncorus' IV-administered Synthetic vRNA demonstrated efficacy in multiple tumor models and avoided the challenge of neutralizing antibodies seen in previous approaches using IV-administered natural viruses
    • Oncorus plans to investigate its Synthetic vRNA immunotherapies in multiple histologies including cancer of the lung
    • Company to host virtual investor event on June 21, 2021 focused on its Synthetic vRNA immunotherapy platform, ONCR-021, ONCR-788, and its in-house manufacturing capabilities and featuring a presentation from Leena Ghandi, M.D., Ph.D., Director, Center for Cancer Therapeutic Innovation at the Dana-Farber Cancer Institute

    CAMBRIDGE, Mass., May 27, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, today announced the nomination of its first Synthetic viral RNA (vRNA) immunotherapy clinical candidates, ONCR-021 and ONCR-788. Oncorus' pioneering intravenous (IV)-administered approach involves encapsulating the genomes of RNA viruses known to kill cancer cells (i.e., oncolytic viruses, or OVs) in a lipid nanoparticle (or LNP), creating a Synthetic vRNA immunotherapy. ONCR-021 encodes an optimized strain of Coxsackievirus A21 (CVA21), and ONCR-788 encodes for a modified version of the Seneca Valley Virus (SVV). Both CVA21 and SVV have extensive clinical experience and favorable safety profiles when administered IV. Oncorus' novel Synthetic vRNA approach holds the potential for IV-administration and avoids the challenge of neutralizing antibodies seen in previous approaches with IV-administered OVs. Oncorus plans to investigate its novel Synthetic vRNA immunotherapies in multiple histologies including cancers of the lung both as monotherapy and in combination with immune checkpoint inhibitors and other cancer treatments.

    "There has been a notable rise in the development and approval of RNA-based vaccines, most prominently for COVID-19, and therapeutics for certain rare diseases. To date, however, there are no approved RNA-based cancer therapies. Simultaneously, the therapeutic benefit of viral immunotherapy has been limited to intratumoral (iTu) administration, restricting broader applications of this modality. In addition, past investigational programs that utilized IV-administered natural OVs faced the challenge of neutralizing antibodies which likely hinders the clinical efficacy of later doses. Our proprietary Synthetic vRNA Immunotherapy Platform involves a highly innovative, novel combination of RNA- and OV-based modalities and, in doing so, holds the potential to create a new pillar in cancer therapy," said Theodore (Ted) Ashburn, M.D., Ph.D., President and CEO of Oncorus.

    LNP-encapsulated IV-administered vRNA to create a "living immunostimulatory drug"

    Developing IV-administered RNA medicines for cancer requires addressing two primary technological hurdles: first, getting adequate concentrations of the RNA-based drug candidate to all tumor cells, and second, limiting exposure to normal tissue throughout the body.

    OVs, through rapid, self-amplification of their genomes in permissive cells and their ability to infect nearby cancer cells, are a potential answer to the challenge of the suboptimal LNP delivery of cargo RNA to tumor cells. In addition, OVs are selected or engineered to replicate more robustly in cells with deficiencies in antiviral responses, as is the case for cancer cells. OVs' selectivity for tumors ensures that their genomes, when delivered by LNP, are minimally or not at all replicating in healthy tissues, thus potentially providing a large therapeutic window for Oncorus' Synthetic vRNA immunotherapy candidates. Furthermore, the immunogenic cell death triggered by OVs, and the release of tumor antigens in an inflamed tumor microenvironment, are expected to broadly stimulate the immune system in its fight against cancer.

    "Taken together, the oncolytic and immunogenic properties of OVs, combined with the broad tissue distribution enabled by IV-administered LNPs and the tumor selective self-amplification afforded by vRNA, opens the door to the successful application of IV-administered RNA medicines in cancer," explained Dr. Ashburn. "This approach holds the promise of improving outcomes for patients across multiple types of cancer, in particular those with cancers of the lung."    

    Christophe Quéva, Ph.D., Oncorus' Chief Scientific Officer, said, "We are proud of our team's work to advance both our oncolytic Herpes Simplex Virus and Synthetic Viral RNA Immunotherapy Platforms. With this dual-platform strategy, we are building a versatile pipeline of iTu-administered and IV-administered viral immunotherapy product candidates that will potentially enable the treatment of a broad range of cancer settings. We continue to advance our lead oHSV candidate, ONCR-177, through Phase 1 study, and we are working diligently to progress our lead synthetic candidates, ONCR-021 and ONCR-788, into the clinic."  

    ONCR-021 and ONCR-788 Clinical Development and In-House GMP Manufacturing

    Oncorus plans to file an investigational new drug (IND) application for ONCR-021 in the first half of 2023 to enable clinical development for non-small cell lung cancer and other cancers such as hepatocellular carcinoma, clear cell renal cell carcinoma and melanoma, both as a single agent and in combination with immune checkpoint inhibitors. Following the IND filing for ONCR-021, Oncorus plans to file an IND for ONCR-788 to enable its development in small cell lung cancer, neuroendocrine prostate and other neuroendocrine cancers, both as a single agent and in combination with immune checkpoint inhibitors and other cancer treatments. In the process of developing ONCR-021 and ONCR-788, Oncorus also developed and optimized a proprietary LNP platform for delivery of large nucleic acids, with efficient endosomal escape. Oncorus will manufacture ONCR-021 and ONCR-788 at its 88,000 square foot state-of-the-art process development and Good Manufacturing Practices (GMP) manufacturing facility in Andover, Mass. With the site buildout underway, Oncorus plans to initiate process development activities at the facility in the second half of 2021 and anticipates this facility will be operational for GMP manufacturing in first half of 2023.

    Link here to a white paper on Oncorus' Synthetic vRNA Immunotherapy Platform and lead candidates.

    Upcoming Synthetic vRNA Immunotherapy-Focused Investor Event

    Oncorus will host a virtual investor event on Monday, June 21, 2021 from 1:00 pm to 3:30 pm ET to discuss details surrounding these Synthetic vRNA programs, including preclinical data supporting the ONCR-021 and ONCR-788 candidate nominations and planned clinical studies. Leena Ghandi, M.D., Ph.D., Director, Center for Cancer Therapeutic Innovation at the Dana-Farber Cancer Institute, will be a featured speaker. For more information or to RSVP for the event, please contact Josh Rauch at .

    About Oncorus

    At Oncorus, we are focused on driving innovation to deliver next-generation viral immunotherapies to transform outcomes for cancer patients. We are advancing a portfolio of intratumorally (iTu) and intravenously (IV) administered viral immunotherapies for multiple indications with significant unmet need based on our oncolytic Herpes Simplex Virus (oHSV) and Synthetic viral RNA (vRNA) Immunotherapy Platforms.

    Designed to deliver next-generation viral immunotherapy impact, our oHSV platform improves upon key characteristics of this therapeutic class to enhance systemic activity. Our lead oHSV program, ONCR-177, is designed to be directly administered into a tumor, resulting in high local concentrations of the therapeutic agent and its five encoded transgenes, as well as low systemic exposure to the therapy, which we believe could potentially limit systemic toxicities. Our pioneering Synthetic vRNA Immunotherapy Platform involves a highly innovative, novel combination of RNA- and oncolytic virus-based modalities to realize the potential of RNA medicines for cancer. Our lead IV-administered Synthetic vRNA clinical candidates, ONCR-021 and ONCR-788, are both currently in IND-enabling studies.

    Please visit www.oncorus.com to learn more.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the preclinical and clinical development of ONCR-021 and ONCR-788, including expectations regarding timing for filing INDs, as well as the product candidates' therapeutic potential and clinical benefits and the utility and potential of Oncorus' Synthetic vRNA Immunotherapy Platform; and expectations regarding the buildout timeline of its viral immunotherapy clinical manufacturing facility. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on Oncorus' operations and the timing and anticipated results of its ongoing and planned clinical trials; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future clinical trials; Oncorus' ability to successfully demonstrate the safety and efficacy of ONCR-021 and ONCR-788; Oncorus' ability to secure adequate quantities of viral immunotherapies manufactured in accordance with regulatory requirements; the expansion of Oncorus' in-house manufacturing capabilities; the adequacy of Oncorus' cash resources and availability of financing on commercially reasonable terms; and Oncorus' ability to obtain, maintain and protect its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Oncorus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 10, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the other filings that Oncorus makes with the Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" page of the Investors section of Oncorus' website at http://investors.oncorus.com. Any forward-looking statements represent Oncorus' views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Oncorus explicitly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

    Investor Contact:Media Contact:
    Alan LadaLiz Melone
    Solebury Trout
    617-221-8006 
     

     



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  2. CAMBRIDGE, Mass., May 26, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, today announced that its President and Chief Executive Officer, Theodore (Ted) Ashburn, M.D., Ph.D., will present at the upcoming Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 2:00 p.m. ET.

    A live webcast of the presentation will be available under the Investors & Media section of Oncorus' website at https://investors.oncorus.com/events-and-presentations. A replay of the presentation will be archived on Oncorus' site for 30 days following the event.

    About Oncorus

    At Oncorus, we are focused on driving innovation to deliver next-generation…

    CAMBRIDGE, Mass., May 26, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, today announced that its President and Chief Executive Officer, Theodore (Ted) Ashburn, M.D., Ph.D., will present at the upcoming Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 2:00 p.m. ET.

    A live webcast of the presentation will be available under the Investors & Media section of Oncorus' website at https://investors.oncorus.com/events-and-presentations. A replay of the presentation will be archived on Oncorus' site for 30 days following the event.

    About Oncorus

    At Oncorus, we are focused on driving innovation to deliver next-generation viral immunotherapies to transform outcomes for cancer patients. We are advancing a portfolio of intratumorally and intravenously administered viral immunotherapies for multiple indications with significant unmet needs based on our oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic Virus Platform. Designed to deliver next-generation viral immunotherapy impact, our oHSV platform improves upon key characteristics of this therapeutic class to enhance potency without sacrificing safety, including greater capacity to encode transgenes to drive systemic immunostimulatory activity, retention of full replication competency to enable high tumor-killing potency, and orthogonal safety strategies to restrict viral activity in tumor cells. Our lead oHSV program, ONCR-177, is designed to be directly administered into a tumor, resulting in high local concentrations of the therapeutic agent, as well as low systemic exposure to the therapy, which we believe could potentially limit systemic toxicities. Please visit www.oncorus.com to learn more.

    Media Contact:

    Liz Melone



    617-256-6622



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  3. -- Enrollment continues in Phase 1 clinical trial of lead oncolytic Herpes Simplex Virus (oHSV) viral immunotherapy candidate ONCR-177; initial interim data expected in 2H'21 --

    -- Company plans to nominate first two intravenously (IV) administered synthetic viral RNA (vRNA) immunotherapy candidates in 1H'21 --

    -- Buildout of GMP clinical manufacturing capabilities and facility remain on track; process development activities anticipated to begin at facility in 2H'21 --

    -- Received $57.0 million in aggregate gross proceeds in February 2021 from public offering --

    CAMBRIDGE, Mass., May 04, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, today reported first quarter 2021 financial results and highlighted recent achievements and developments.

    "We began 2021 with strong momentum, announcing the buildout of our GMP manufacturing facility which is now well underway, and we continue to advance our ambitious goals on behalf of cancer patients," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus.

    Dr. Ashburn further commented, "We continue to enroll patients in a Phase 1 clinical trial of ONCR-177, our lead oncolytic Herpes Simplex Virus (oHSV) clinical candidate, and expect initial interim data later this year. We also anticipate nominating our first two synthetic viral RNA (vRNA) immunotherapy candidates in the first half of 2021. These candidates are comprised of vRNA coding for oncolytic viruses encapsulated within lipid nanoparticles, or LNPs – proprietary technologies developed by the Oncorus team. We have designed this novel approach to enable the systemic, repeat intravenous (IV) administration of viral immunotherapies, the so-called ‘holy grail' of this modality, to date unattainable. We're excited to introduce this breakthrough approach and discuss these candidates in more detail at an upcoming virtual investor event."

    First Quarter 2021 and Recent Highlights

    • Enrolling Phase 1 clinical trial of ONCR-177. Oncorus is currently enrolling a Phase 1 clinical trial of its lead product candidate, ONCR-177, an intratumorally (iTu) administered oHSV viral immunotherapy being developed for multiple solid tumor indications. The Phase 1 open-label, multi-center, dose escalation and expansion clinical trial is designed to evaluate the safety and tolerability of ONCR-177. The trial will determine the recommended Phase 2 dose, as well as investigate ONCR-177's preliminary anti-tumor activity, alone and in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors. Oncorus has an ongoing clinical trial collaboration with Merck involving KEYTRUDA and anticipates reporting interim data from the Phase 1 trial in the second half of 2021 through the second half of 2022.

    • Advancing lead Synthetic vRNA Immunotherapy Platform programs toward clinical candidate nomination. Oncorus continues to advance its lead synthetic, IV administered vRNA immunotherapy programs based on the Coxsackievirus A21 (CVA21) and the Seneca Valley Virus (SVV). The company expects to nominate clinical candidates for both programs in the first half of 2021. IV administration of viral immunotherapies is an attractive approach for improving the standard of care for many cancer patients because it allows for all tumors, including micro-metastases, to be directly treated. In addition, it allows for the potential treatment of certain tumors, such as those of the lung, that are less amenable to repeat iTu injection of anti-cancer therapies due to safety and feasibility considerations. Oncorus' Synthetic vRNA Immunotherapy Platform includes a novel LNP delivery strategy designed to overcome the challenges caused by neutralizing antibodies, which have limited the efficacy of previous industry efforts to treat tumors utilizing IV administration of OVs.

    • Advancing second oHSV viral immunotherapy candidate, ONCR-GBM. Leveraging its oHSV Platform, Oncorus is pursuing ONCR-GBM to specifically target brain cancer, including glioblastoma multiforme (GBM). The company is utilizing its knowledge of microRNA expression to engineer a microRNA attenuation strategy to protect healthy brain tissue and select a combination of payloads intended to address the specific drivers of immune suppression in brain cancer. Oncorus plans to nominate its ONCR-GBM clinical candidate in the second half of 2021.

    • Announced buildout of Good Manufacturing Practice (GMP) viral immunotherapy clinical manufacturing facility. In January 2021, Oncorus announced the signing of a 15-year lease to build a state-of-the-art, 88,000 square foot GMP viral immunotherapy clinical manufacturing facility in Andover, Mass. The facility is intended to provide a comprehensive solution for Oncorus' Chemistry, Manufacturing and Controls (CMC) development needs, enabling the manufacture, quality, control and supply of clinical-grade viral immunotherapies for investigational new drug (IND)-enabling and clinical studies. Oncorus anticipates the first phase of the facility's buildout will be completed in late 2021, including process development and quality control, with GMP multi-product manufacturing capabilities and full operation commencing in early 2023.

    • Completed follow-on public offeringIn February 2021, Oncorus completed an underwritten public offering of common stock, at a price of $19.00 per share, raising $57.0 million in aggregate gross proceeds.

    First Quarter Financial Results

    • Cash and cash equivalents were $172.6 million as of March 31, 2021 compared to $130.3 million as of December 31, 2020.
    • Research and development expenses for the quarter ended March 31, 2021 were $8.4 million compared to $5.9 million for the corresponding quarter in 2020. The increase in research and development expenses was mainly attributable to increased rent expense related to the Company's new manufacturing facility, increased personnel-related expenses, including stock-based compensation, driven by increased headcount and increased clinical trial costs for the Company's ongoing Phase 1 clinical trial of ONCR-177.
    • General and administrative expenses for the quarter ended March 31, 2021 were $4.2 million compared to $2.1 million for the corresponding quarter in 2020. The increase in general and administrative expenses was primarily attributable to increases in personnel-related expenses, including stock-based compensation, driven by increased compensation and increased headcount and increased costs, such as insurance expense and professional and consultant expenses, related to operating as a public company.
    • Net loss attributable to common stockholders for the quarter ended March 31, 2021 was $12.7 million, or $0.53 per share, compared to a net loss attributable to common stockholders of $10.6 million, or $10.59 per share for the same quarter in 2020. The share and loss per share amounts in the first quarter of 2021 reflect the impact of the company's IPO, which closed in October 2020, including the conversion of outstanding preferred stock into approximately 15.0 million shares of common stock.

    Financial Guidance

    Based upon its current operating plans and cash and cash equivalents, Oncorus expects to have sufficient capital to fund its operating expenses and capital expenditure requirements into late 2023.

    About Oncorus

    At Oncorus, we are focused on driving innovation to deliver next-generation viral immunotherapies to transform outcomes for cancer patients. We are advancing a portfolio of intratumorally and intravenously administered viral immunotherapies for multiple indications with significant unmet needs based on our oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic viral RNA (vRNA) Immunotherapy Platform. Designed to deliver next-generation viral immunotherapy impact, our oHSV platform improves upon key characteristics of this therapeutic class to enhance potency without sacrificing safety, including greater capacity to encode transgenes to drive systemic immunostimulatory activity, retention of full replication competency to enable high tumor-killing potency, and orthogonal safety strategies to restrict viral activity to tumor cells. Our lead program, ONCR-177, is designed to be directly administered into a tumor, resulting in high local concentrations of the therapeutic agent, as well as low systemic exposure to the therapy, which we believe could potentially limit systemic toxicities. Please visit www.oncorus.com to learn more.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the clinical development of ONCR-177, including expectations regarding timing for reporting data from the ongoing Phase 1 clinical trial, as well as the product candidate's therapeutic potential and clinical benefits; Oncorus' expectations regarding upcoming milestones for its other potential product candidates, including the timing for nomination of candidates from its two Synthetic vRNA Immunotherapy Platform development programs and its second oHSV Platform program, ONCR-GBM; expectations regarding the buildout timeline of its viral immunotherapy clinical manufacturing facility and its belief that its current cash resources will be sufficient to fund its operations into late 2023. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on Oncorus' operations and the timing and anticipated results of its ongoing and planned clinical trials; the risk that the results of a clinical trial may not be predictive of future results in connection with future clinical trials; Oncorus' ability to successfully demonstrate the safety and efficacy of ONCR-177 and obtain regulatory approval; and Oncorus' ability to obtain, maintain and protect its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Oncorus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 10, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the other filings that Oncorus makes with the Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" page of the Investors section of Oncorus' website at http://investors.oncorus.com.

    Any forward-looking statements represent Oncorus' views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Oncorus explicitly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

    Investor Contact:

    Alan Lada

    Solebury Trout

    617-221-8006

    Media Contact:

    Liz Melone





    Oncorus, Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (in thousands, except per share data)

    (Unaudited)

     
     Three Months Ended
     March 31,
      2021   2020 
    Operating expenses:   
    Research and development$8,447  $5,892 
    General and administrative 4,222   2,052 
    Total operating expenses 12,669   7,944 
    Loss from operations (12,669)  (7,944)
    Other income (expense):   
    Other expense -   (11)
    Interest income 6   128 
    Total other income (expense), net 6   117 
    Net loss and comprehensive loss$(12,663) $(7,827)
    Accretion of discount and dividends on redeemable convertible preferred stock -   (2,725)
    Net loss attributable to common stockholders$(12,663) $(10,552)
    Net loss per share - basic and diluted$(0.53) $(10.59)
    Weighted-average number of common shares - basic and diluted 24,009   996 
            



    Oncorus, Inc.
    Selected Condensed Consolidated Balance Sheet Data
    (in thousands)
    (Unaudited)
     
     March 31,

      December 31,
      2021   2020 
    Cash and cash equivalents$172,622  $130,305 
    Working capital (1) 168,763   127,407 
    Right-of-use asset 40,847   41,372 
    Total assets 225,107   182,263 
    Long term lease liability 42,083   41,615 
    Total liabilities 48,852    47,599 
    Total stockholders' equity$176,255  $

    134,664 
            

    (1) Working capital is defined as current assets less current liabilities



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