ONCR Oncorus Inc.

14.16
-0.09  -1%
Previous Close 14.25
Open 14.03
52 Week Low 11.5
52 Week High 37.8603
Market Cap $362,854,390
Shares 25,625,310
Float 17,907,487
Enterprise Value $277,463,667
Volume 110,986
Av. Daily Volume 191,955
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    • 2020 marked year of notable progress for Oncorus. Key highlights included:
      • Transitioned to clinical-stage company with initiation of Phase 1 clinical trial of lead viral immunotherapy candidate, ONCR-177, for the treatment of solid tumors
      • Announced clinical trial collaboration and supply agreement with Merck to evaluate combination of ONCR-177 with KEYTRUDA® (pembrolizumab) as part of ongoing ONCR-177 Phase 1 clinical trial
      • Completed IPO, receiving $98.4 million in aggregate gross proceeds
      • Commenced strategic planning for operational and manufacturing scale-up, including signing of a 15-year lease to build a state-of-the-art, 88,000 square foot GMP viral immunotherapy clinical manufacturing facility
      • $130.3 million in cash and cash equivalents as…
    • 2020 marked year of notable progress for Oncorus. Key highlights included:

      • Transitioned to clinical-stage company with initiation of Phase 1 clinical trial of lead viral immunotherapy candidate, ONCR-177, for the treatment of solid tumors
      • Announced clinical trial collaboration and supply agreement with Merck to evaluate combination of ONCR-177 with KEYTRUDA® (pembrolizumab) as part of ongoing ONCR-177 Phase 1 clinical trial
      • Completed IPO, receiving $98.4 million in aggregate gross proceeds
      • Commenced strategic planning for operational and manufacturing scale-up, including signing of a 15-year lease to build a state-of-the-art, 88,000 square foot GMP viral immunotherapy clinical manufacturing facility
      • $130.3 million in cash and cash equivalents as of December 31, 2020     
    • In February 2021, Oncorus completed an underwritten public offering of common stock, resulting in aggregate gross proceeds of $57.0 million
    • Company anticipates continued growth and progress in 2021 across its pipeline and business, including initial interim data readout of ONCR-177 Phase 1 clinical trial in second half of 2021

    CAMBRIDGE, Mass., March 10, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, today reported fourth quarter and full year 2020 financial results and provided business highlights.

    "2020 was a year of significant evolution for Oncorus as we successfully transitioned to a clinical-stage and publicly-traded company," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "In addition to moving our lead viral immunotherapy candidate, ONCR-177, into a clinical trial, we continued to advance multiple pipeline candidates across our oncolytic Herpes Simplex Virus (oHSV) and Synthetic Virus Platforms. We also began to plan operational and manufacturing scale-up to support our anticipated growth in the coming years."

    Dr. Ashburn continued, "Bolstered by a strong cash position, we anticipate multiple milestones in 2021 that will further advance Oncorus' leadership in the viral immunotherapy space. These include the initial interim data readout from our ongoing ONCR-177 clinical trial, the nomination of our first intravenously administered synthetic virus clinical candidates as well as our second intratumorally administered oHSV clinical candidate, and the completion of the first buildout phase of our GMP clinical manufacturing facility. We look forward to continued growth throughout 2021, driven by our mission to realize the full promise of viral immunotherapy for cancer patients."

    Oncorus anticipates reporting interim data from its ongoing Phase 1 clinical trial of its lead oHSV-based clinical candidate ONCR-177 in patients with solid tumor indications in the second half of 2021 through the second half of 2022. The company plans to nominate its first synthetic virus clinical candidates, coxsackievirus A21 and Seneca Valley Virus programs, in the first half of 2021 and its second oHSV clinical candidate, which will specifically target brain cancer, including glioblastoma multiforme, in the second half of 2021.

    Fourth Quarter and Full Year 2020 and Recent Highlights

    Recent Highlights

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

    • 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 studies 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. Oncorus plans to continue partnering with contract manufacturing organizations to provide additional support and capacity. The company expects to employ up to 100 Oncorus team members at the site.



    • Announced publication of ONCR-177 preclinical data demonstrating potent and durable antitumor activity. In January 2021, Oncorus announced the recent publication of preclinical data supporting the clinical development of ONCR-177. In the paper, entitled, "ONCR-177, an Oncolytic HSV-1 Designed to Potently Activate Systemic Antitumor Immunity" (Haines, et al., 2020), published online in the journal Cancer Immunology Research, ONCR-177 demonstrated potent and durable antitumor activity in multiple immune-competent tumor models. The preclinical activity of ONCR-177 was shown to be driven by Oncorus' unique combination of five complementary immunomodulatory transgene payloads in addition to its retention of γ34.5. A herpes simplex virus 1 (HSV-1) gene, γ34.5 allows the virus to replicate in the presence of host antiviral immune responses.

    Fourth Quarter and Full Year 2020 Highlights

    • Appointed Steve Harbin as Chief Operating Officer (COO) and Chief of Staff. In December 2020, Oncorus appointed Steve Harbin as COO and Chief of Staff, to lead planning and execution of its anticipated operational and manufacturing scale-up. Mr. Harbin brings more than 30 years of diverse operational experience in biotech, pharmaceuticals and in-vitro diagnostics. His experience includes serving in several executive committee roles at Moderna, Inc. for six years, where he was a key driver of the company's successful growth strategy, overseeing clinical and non-clinical manufacturing operations, supply chain, facilities and human resources. Previously Mr. Harbin served as Senior Vice President, Global Operations for France-based bioMérieux SA, and also held multiple leadership roles within Eli Lilly and Company globally.



    • Expanded Board of Directors with appointment of Scott Canute. In December 2020, Oncorus expanded its Board with the appointment of Scott Canute. Mr. Canute has nearly 40 years of broad experience in the biopharmaceutical industry, including leading global manufacturing and operations strategy and execution for Genzyme Corporation and Eli Lilly and Company.



    • Completed initial public offering. In October 2020, Oncorus completed the initial public offering of shares of its common stock at a public offering price of $15.00 per share, and raised $98.4 million in aggregate gross proceeds, including shares sold to the underwriters pursuant to a partial exercise of their option to purchase additional shares. On October 2, 2020, Oncorus' common stock commenced trading on the Nasdaq Global Market under the ticker symbol "ONCR".

    • Publication of preclinical data characterizing ONCR-177's safety strategies. In September 2020, ONCR-177's safety strategies and their ability to enhance oHSV tolerability without impeding potency were characterized in a paper published in Molecular Therapy on ONCR-159, the unarmed version of ONCR-177, titled, "Design of an Interferon-Resistant Oncolytic HSV-1 Incorporating Redundant Safety Modalities for Improved Tolerability." (Kennedy et al., 2020). Oncorus' oHSV platform incorporates two complementary and proprietary safety approaches, including a microRNA attenuation strategy to allow unencumbered viral replication in tumor cells while preventing replication in healthy tissues, and engineered proprietary mutations into UL37 to eliminate the virus' ability to transport, replicate and establish latency inside neurons.

    • Announced clinical trial collaboration with Merck. In July 2020, Oncorus entered into a clinical trial collaboration and supply agreement with Merck (NYSE:MRK), known as MSD outside of the United States and Canada, through a subsidiary, to evaluate the combination of ONCR-177 with KEYTRUDA® (pembrolizumab), as part of the ongoing Phase 1 clinical trial of ONCR-177 in adult patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors.

    • Initiated Phase 1 clinical trial of ONCR-177. In June 2020, Oncorus initiated a Phase 1 clinical trial of its lead product candidate, ONCR-177, an intratumorally 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 and to determine the recommended Phase 2 dose, as well as its 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 anticipates reporting interim data from the Phase 1 clinical trial in the second half of 2021 through the second half of 2022.

    Fourth Quarter Financial Results

    • Cash and cash equivalents were $130.3 million as of December 31, 2020 compared to $45.3 million as of December 31, 2019.
    • Research and development expenses for the quarter ended December 31, 2020 were $7.6 million compared to $5.9 million for the corresponding period in 2019. The increase in research and development expenses was mainly attributable to increases in clinical trial costs for the company's Phase 1 clinical trial as well as increased personnel-related expenses driven by increased headcount.  
    • General and administrative expenses for the quarter ended December 31, 2020 were $4.0 million compared to $3.1 million for the corresponding period in 2019. The increase in general and administrative expenses was primarily attributable to increases in personnel-related expenses driven by increased headcount as well as increased costs associated with the Company's transition to a public company in the fourth quarter of 2020.  



    • Net loss attributable to common stockholders for the quarter ended December 31, 2020 was $(11.8) million, or $(0.56) per share, compared to a net loss attributable to common stockholders of $(11.5) million, or $(11.78) per share for the same period in 2019. The share and loss per share amounts in the fourth quarter of 2020 reflect the impact of the company's IPO, which closed in October 2020.

    Financial Guidance

    Based upon its current operating plans and cash and cash equivalents at December 31, 2020, plus the net proceeds from the public offering of common stock in February 2021, the company 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 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 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 Virus 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, to be 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 Lada  Liz Melone
     Solebury Trout  
     617-221-8006 
       















    Oncorus, Inc.
     
    Condensed Consolidated Statements of Operations and Comprehensive Loss 
    (in thousands, except per share data) 
    (Unaudited) 
              
       Three Months Ended Year Ended 
       December 31,  December 31,  
           
        2020   2019   2020   2019 
            
    Operating expenses:               
     Research and development$7,593  $5,864  $27,153  $24,047 
     General and administrative 3,968   3,141   10,000   7,119 
    Total operating expenses 11,561   9,005   37,153   31,166 
    Loss from operations (11,561)  (9,005)  (37,153)  (31,166)
    Other income (expense):       
     Change in fair value of Series B tranche rights -   -   (11,256)  - 
     Other expense (11)  (40)  (33)  (47)
     Interest income 5   178   143   509 
          Total other income (expense), net (6)  138   (11,146)  462 
    Net loss and comprehensive loss$(11,567) $(8,867) $(48,299) $(30,704)
    Accretion of discount and dividends on redeemable convertible preferred stock (229)  (2,678)  (8,527)  (4,287)
    Net loss attributable to common stockholders$(11,796) $(11,545) $(56,826) $(34,991)
    Net loss per share - basic and diluted$(0.56) $(11.78) $(9.35) $(37.42)
    Weighted-average number of common shares - basic and diluted 21,126   980   6,080   935 
              
              
    Oncorus, Inc. 
    Selected Condensed Consolidated Balance Sheet Data 
    (in thousands) 
    (Unaudited) 
           December 31, 2020 December 31, 2019
    Cash and cash equivalents    $130,305  $45,286 
    Working capital (1)     127,407   40,963 
    Right-of-use asset (2)     41,372   - 
    Total assets     182,263   50,826 
    Long term lease liability (2)     41,615   - 
    Total liabilities     47,599   8,491 
    Redeemable convertible preferred stock     -   116,632 
    Total stockholders' equity (deficit)    $134,664  $(74,297)
              

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

    (2) Reflects the adoption of ASC 842, Leases, as of January 1, 2020 resulting in capitalization of right of use assets and a corresponding liability for the Company's operating leases

     



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  1. CAMBRIDGE, Mass., Feb. 11, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation, systemically active viral immunotherapies to transform outcomes for cancer patients, today announced the pricing of its underwritten public offering of 3,000,000 shares of its common stock at a price to the public of $19.00 per share. All shares of common stock in the offering are being offered by Oncorus. The gross proceeds to Oncorus from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $57.0 million. In addition, Oncorus has granted the underwriters a 30-day option to purchase up to an additional 450,000 shares of common stock…

    CAMBRIDGE, Mass., Feb. 11, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation, systemically active viral immunotherapies to transform outcomes for cancer patients, today announced the pricing of its underwritten public offering of 3,000,000 shares of its common stock at a price to the public of $19.00 per share. All shares of common stock in the offering are being offered by Oncorus. The gross proceeds to Oncorus from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $57.0 million. In addition, Oncorus has granted the underwriters a 30-day option to purchase up to an additional 450,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on February 17, 2021, subject to satisfaction of customary closing conditions.

    Jefferies, Evercore ISI and Piper Sandler are acting as joint book-running managers for the offering.

    A registration statement relating to these securities has been filed with the Securities and Exchange Commission (SEC) and was declared effective on February 11, 2021. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering, when available, may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, via telephone at (877) 821-7388 or via email at ; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at (888) 474-0200, or by email at ; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, via telephone at (800) 747-3924 or via email at .

    About Oncorus

    At Oncorus, we are focused on driving innovation to deliver next-generation, systemically active 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. Oncorus' 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.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning the expected gross proceeds, timing, satisfaction of closing conditions and our ability to complete the offering. 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: the impact of COVID-19 on Oncorus' operations and the timing and anticipated results of its ongoing and planned preclinical studies and clinical trials; the risk that the preliminary results of preclinical studies or 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-177 and obtain regulatory approval and that Oncorus' other preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; 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' Registration Statement on Form S-1 filed with the SEC on February 9, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the other filings that Oncorus makes with the SEC from time to time.

    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



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  2. CAMBRIDGE, Mass., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation, systemically active viral immunotherapies to transform outcomes for cancer patients, today announced it has commenced an underwritten public offering of 3,000,000 shares of its common stock. All shares of common stock to be sold in the offering will be sold by Oncorus. In addition, Oncorus intends to grant the underwriters a 30-day option to purchase up to an additional 450,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The public offering price has not yet been determined. The offering is subject to market and other conditions and there…

    CAMBRIDGE, Mass., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation, systemically active viral immunotherapies to transform outcomes for cancer patients, today announced it has commenced an underwritten public offering of 3,000,000 shares of its common stock. All shares of common stock to be sold in the offering will be sold by Oncorus. In addition, Oncorus intends to grant the underwriters a 30-day option to purchase up to an additional 450,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The public offering price has not yet been determined. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Jefferies, Evercore ISI and Piper Sandler are acting as joint book-running managers for the offering.

    A registration statement relating to these securities has been filed with the Securities and Exchange Commission (SEC), but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the proposed offering, when available, may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, via telephone at (877) 821-7388 or via email at ; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at (888) 474-0200, or by email at ; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, via telephone at (800) 747-3924 or via email at .

    About Oncorus

    At Oncorus, we are focused on driving innovation to deliver next-generation, systemically active 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. Oncorus' 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.

    Cautionary Note Regarding Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: the completion, timing, terms and size of the proposed offering and Oncorus' expectations with respect to granting the underwriters a 30-day option to purchase additional shares. 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: the impact of COVID-19 on Oncorus' operations and the timing and anticipated results of its ongoing and planned preclinical studies and clinical trials; the risk that the preliminary results of preclinical studies or 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-177 and obtain regulatory approval and that Oncorus' other preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; 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' Registration Statement on Form S-1 filed with the SEC on February 9, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the other filings that Oncorus makes with the SEC from time to time.

    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



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  3. -- Preclinical findings show that ONCR-177's systemic antitumor immunity is driven by its five complementary immunomodulatory transgene payloads and retention of γ34.5 --

    -- Complete and durable tumor regression and protective antitumor memory observed in multiple syngeneic tumor models --

    -- Preclinical safety data and preliminary readout from the ongoing Phase 1 study support Oncorus' proprietary safety strategies --

    CAMBRIDGE, Mass. , Jan. 20, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation, systemically active viral immunotherapies to transform outcomes for cancer patients, announced today the recent publication of preclinical data supporting the clinical development…

    -- Preclinical findings show that ONCR-177's systemic antitumor immunity is driven by its five complementary immunomodulatory transgene payloads and retention of γ34.5 --

    -- Complete and durable tumor regression and protective antitumor memory observed in multiple syngeneic tumor models --

    -- Preclinical safety data and preliminary readout from the ongoing Phase 1 study support Oncorus' proprietary safety strategies --

    CAMBRIDGE, Mass. , Jan. 20, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation, systemically active viral immunotherapies to transform outcomes for cancer patients, announced today the recent publication of preclinical data supporting the clinical development of its lead oncolytic Herpes Simplex Virus (oHSV) clinical candidate, ONCR-177. In the paper, entitled, "ONCR-177, an Oncolytic HSV-1 Designed to Potently Activate Systemic Antitumor Immunity" (Haines, et al., 2020), published online in the journal Cancer Immunology Research, ONCR-177 demonstrated potent and durable antitumor activity in multiple immune-competent tumor models. The preclinical findings demonstrate that the activity of ONCR-177, an intratumorally administered viral immunotherapy engineered for systemic activity currently in a Phase 1 study, is driven by Oncorus' unique combination of five complementary immunomodulatory transgene payloads in addition to its retention of γ34.5. A herpes simplex virus 1 (HSV-1) gene, γ34.5 allows the virus to replicate in the presence of host antiviral immune responses. ONCR-177's safety strategies and their ability to enhance oHSV tolerability without impeding potency were previously characterized in a paper published by Oncorus in September 2020 in Molecular Therapy on ONCR-159, the unarmed version of ONCR-177, (Kennedy et al., 2020) titled, "Design of an Interferon-Resistant Oncolytic HSV-1 Incorporating Redundant Safety Modalities for Improved Tolerability."

    "We are pleased to share these encouraging preclinical findings, which supported our advancement of ONCR-177 into clinical development last year. These data give important insight into how our proprietary engineering of ONCR-177 may enable systemic activity without compromising safety, and position us to advance our mission to realize the full potential of this therapeutic class for cancer patients," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer at Oncorus. "We believe viral immunotherapies as a class are a proven modality and represent the most promising approach in development today to activate multiple arms of the immune system and improve outcomes for cancer patients."

    Oncorus is conducting a Phase 1 study to evaluate the safety and tolerability of ONCR-177 as well as to evaluate preliminary antitumor activity in patients with solid tumors (NCT04348916) as a monotherapy and in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) via a clinical trial collaboration and supply agreement signed with Merck in July 2020. Oncorus expects to report initial interim data from the monotherapy dose escalation part of this trial in the second half of 2021 with addition data readouts through the second half of 2022.

    Christophe Quéva, Ph.D., Oncorus' Chief Scientific Officer and Senior Vice President, Research, commented, "We have designed our proprietary oHSV Platform to safely maximize the impact of viral immunotherapies to foster the development of a potent systemic antitumor activity. With our Phase 1 study of ONCR-177 now well underway, we look forward to the potential of these preclinical findings translating into improving patient outcomes."

    In addition to ONCR-177, Oncorus plans to nominate a second intratumorally administered oHSV clinical candidate to specifically target cancers of the central nervous system, including glioblastoma multiforme, in the second half of 2021 (ONCR-GBM). In the first half of 2021, Oncorus plans to nominate intravenously administered Synthetic Coxsackievirus A21 and Synthetic Seneca Valley Virus clinical candidates from its Synthetic Virus Platform for difficult-to-inject tumors such as those of the lung.

    Preclinical Data Highlights

    Highlights from Oncorus' preclinical data described in these papers include:

    • The murine version of ONCR-177 (mONCR-171) demonstrated durable complete tumor regressions and abscopal activity in four syngeneic tumor models: A20, MC38, CT26 and B16F10N1.
    • Durable survival was achieved in both A20 and CT26 models versus the unarmed version of ONCR-177 (i.e., ONCR-159), specifically demonstrating the impact that ONCR-177's arming strategy has in driving systemic activity in these in vivo models of cancer. Re-challenge experiments in long term responders to mONCR-171 demonstrated that tumor antigen-specific protective memory responses were achieved.
    • The retention of a gene coding for γ34.5 demonstrated more robust replication in the presence of interferon-γ versus viruses that do not contain this gene. Of note, ONCR-159, which also retains γ34.5 expression, demonstrated statistically significant improvement in an in vivo bi-lateral CT26 model of survival.
    • The addition of systemic anti-PD-1 augmented the activity of mONCR-171, particularly for un-injected tumors, suggesting that utilizing systemic anti-PD-1 immunotherapy may augment the systemic antitumor effect of ONCR-177.
    • Directional viral promoters, CAG and MND, were shown to elicit strong transgene expression in injected tumors. Furthermore, the addition of the five complementary immunomodulatory transgenes and other modifications in ONCR-177 remain potently oncolytic in vitro in cancer cell lines. The oncolytic activity of ONCR-177 is on par with what has been reported for talimogene laherparepvec (IMLYGIC®), which is commonly referred to as "T-VEC".1
    • In vivo biodistribution analyses suggest that viral DNA and transgene expression were relegated primarily to the injected tumor. As previously disclosed, no dose limiting toxicities were observed in the first four patients dosed with ONCR-177 suggesting that the safety strategies incorporated into ONCR-177 are working as intended.

    About ONCR-177

    ONCR-177, Oncorus' lead viral immunotherapy candidate, is designed to mount a multidimensional attack on cancer. It induces immunogenic cancer cell death and ignites innate and adaptive immunity to drive a lasting and systemic anti-tumor response.

    Five Complementary Immunomodulatory Transgene Payloads to Recruit Multiple Arms of Immune System

    ONCR-177 is armed with five complementary transgenes with strong clinical and preclinical validation, IL-12, FLT3LG, CCL4, anti-PD-1 and anti-CLTA-4, which were selected by Oncorus to comprehensively drive the Cancer-Immunity Cycle2 at multiple nodes:

    • IL-12 is known to activate and expand CD8, CD4 TH1 and natural killer (NK) cells.
    • FLT3LG is well understood to expand antigen cross-presenting classical dendritic cells, and CCL4 is known facilitate dendritic and CD8 T cell recruitment.
    • ONCR-177's local expression of agonists to PD-1 (via a proprietary PD-1 nanobody) and CTLA-4 (using the ipilimumab sequence) is intended to counteract compensatory upregulation of key immune checkpoints.

    γ34.5 Retention to Enable Resistance to Host Antiviral Immune Responses and Additional Innovations

    ONCR-177 also retains a copy of γ34.5 to enable resistance to host antiviral interferon responses. γ34.5 is known to play a more central role in inhibition of antiviral response than US11.3 Furthermore, ONCR-177 contains a gB:N/T mutation in a surface fusion protein shown to broaden tropism beyond Herpesvirus entry mediator (HVEM) and nectin-1 to include nectins-2, 3 and 4 and enhance infectivity.4 Lastly, ONCR-177 contains inactivating null mutations in ICP47 intended to improve antigen presentation.5

    Orthogonal Safety Strategies to Enable Selective Attenuation and Retention of γ34.5

    Oncorus' oHSV platform incorporates two complementary and proprietary approaches to limit viral replication in normal tissues. First, Oncorus' microRNA attenuation strategy leverages the known differential expression of certain microRNA in tumors versus normal tissues to allow unencumbered viral replication in tumor cells, while preventing replication in healthy tissues. This microRNA attenuation strategy allows ONCR-177 to retain the ability to express the gene encoding for γ34.5, a feature unique among oHSV-based therapies such as T-VEC and others in development today. In addition, ONCR-177 also has engineered proprietary mutations into UL37 to eliminate the virus' ability to transport, replicate and establish latency inside neurons.6

    About Oncorus

    At Oncorus, we are focused on driving innovation to deliver next-generation, systemically active 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. Oncorus' 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 us at 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:  expectations with respect to Oncorus' ability to advance its clinical and preclinical pipelines, including statements regarding the clinical development of ONCR-177 and timing and anticipated data read-outs for the ongoing Phase 1 clinical trial; Oncorus' expectations regarding upcoming milestones for its other potential product candidates, including the timing for nomination of clinical candidates from its two Synthetic Virus Platform development programs and its second oHSV Platform clinical candidate; and the therapeutic potential and clinical benefits of Oncorus' existing and potential product candidates. 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 preclinical studies and clinical trials; the risk that the preliminary results of preclinical studies or 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-177 and obtain regulatory approval and that Oncorus' other preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; 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' Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which was filed with the Securities and Exchange Commission on November 12, 2020, 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                             

    ___________________________________________________  

    1 Moesta, et al, Cancer Research 2017

    2 Chen and Mellman, Immunity 2013

    3 Mulvey et al., J. Virol. 2004 and Peters et al., J. Virol. 2018

    4 Uchida, J. Virol. 2010

    5 Twumasi-Boateng, Nat. Rev. Cancer 2018

    6 Richards et al., PLoS Pathog. 2017 



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  4. -- 88,000 square foot state-of-the-art facility will support Oncorus' advancing, multi-product pipeline of intratumorally and intravenously administered viral immunotherapies

    -- Initial phase of site buildout anticipated to be completed in fourth quarter 2021 --

    -- Company anticipates site will be fully operational in early 2023 and expects to employ up to 100 Oncorus team members --

    CAMBRIDGE, Mass., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation viral immunotherapies to transform outcomes for cancer patients, announced today that it has signed a 15-year lease to build a state-of-the-art, 88,000 square foot Good Manufacturing Practice (GMP) viral…

    -- 88,000 square foot state-of-the-art facility will support Oncorus' advancing, multi-product pipeline of intratumorally and intravenously administered viral immunotherapies

    -- Initial phase of site buildout anticipated to be completed in fourth quarter 2021 --

    -- Company anticipates site will be fully operational in early 2023 and expects to employ up to 100 Oncorus team members --

    CAMBRIDGE, Mass., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation viral immunotherapies to transform outcomes for cancer patients, announced today that it has signed a 15-year lease to build a state-of-the-art, 88,000 square foot Good Manufacturing Practice (GMP) viral immunotherapy clinical manufacturing facility in Andover, Mass.

    Oncorus is advancing a portfolio of intratumorally and intravenously administered viral immunotherapies for multiple cancer indications with significant unmet needs based on its oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic Virus Platform. The company is currently conducting a Phase 1 clinical trial of its lead product candidate, ONCR-177, an intratumorally administered oHSV viral immunotherapy being developed for multiple solid tumor indications. The company anticipates reporting interim data from this Phase 1 trial in the second half of 2021 through the second half of 2022. Oncorus plans to nominate its first intravenously administered synthetic virus clinical candidates (coxsackievirus A21 and Seneca Valley Virus programs) in the first half of 2021 and its second intratumorally administered oHSV clinical candidate, which will specifically target brain cancer, including glioblastoma multiforme, in the second half of 2021.

    "Last year was a year of tremendous progress for Oncorus. We initiated a first-in-human study of our lead viral immunotherapy program, ONCR-177, signed a clinical collaboration agreement and supply agreement with Merck for ONCR-177, made strides advancing multiple earlier stage programs, successfully completed an IPO, and continued to strengthen our team," said Theodore (Ted) Ashburn, M.D., Ph.D., President and CEO at Oncorus. "Now we're thrilled to announce that we've signed a lease for our planned manufacturing facility, which will play a central role in enabling us to advance our mission to realize the full promise of viral immunotherapy for cancer patients. Operational and manufacturing scale-up will be a strategic priority for Oncorus going forward."

    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 studies 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. Oncorus plans to continue partnering with contract manufacturing organizations to provide additional support and capacity.

    "The investment in this manufacturing facility demonstrates our commitment to growth and innovation," said Steve Harbin, Chief Operations Officer and Chief of Staff at Oncorus. "In addition to ramping up GMP activities to support our near-term development needs, we also plan to build robust process development and scale-up infrastructure, which is critical for future efforts, including potential commercial launch support. This facility will give us control over quality and output and enhanced flexibility as we develop our multiple oHSV- and synthetic virus-based viral immunotherapy programs."

    Mr. Harbin, who recently joined Oncorus, is responsible for guiding operations and manufacturing at the company in addition to its Talent and Culture function. Previously, he held senior executive manufacturing and operations leadership roles in the U.S. and globally with Moderna, Inc., bioMérieux SA, and Eli Lilly and Company.

    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 us at 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: expectations with respect to Oncorus' ability to advance its clinical and pre-clinical pipelines, including statements regarding the clinical development of ONCR-177 and timing of reporting interim data, expectations regarding upcoming milestones for its other potential product candidates, as well as the therapeutic potential and clinical benefits of Oncorus' product candidates; Oncorus' expectations with respect to its continued growth, including its ability to expand its infrastructure and organization and its ability to scale-up its platforms, buildout its manufacturing capabilities, including the anticipated timing for completion of the initial buildout phase and full operating capacity at Oncorus' newly leased manufacturing facility, and secure additional manufacturing capacity; the ability of the leadership team to execute Oncorus' strategy and support its future growth; and statements regarding the accomplishments, experience and capabilities of individual members of Oncorus' leadership team and the ability of such qualities to drive Oncorus' success. 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 development of its manufacturing capabilities and progression of its product candidates into the operational scale-up phase; 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' Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which was filed with the Securities and Exchange Commission on November 12, 2020, 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 
    trout.com 



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