- 2020 marked yr of notable progress for Oncorus. Key highlights included:
- Transitioned to clinical-stage firm with initiation of Part 1 scientific trial of lead viral immunotherapy candidate, ONCR-177, for the therapy of strong tumors
- Introduced scientific trial collaboration and provide settlement with Merck to judge mixture of ONCR-177 with KEYTRUDA® (pembrolizumab) as a part of ongoing ONCR-177 Part 1 scientific trial
- Accomplished IPO, receiving $98.4 million in combination gross proceeds
- Commenced strategic planning for operational and manufacturing scale-up, together with signing of a 15-year lease to construct a state-of-the-art, 88,000 sq. foot GMP viral immunotherapy scientific manufacturing facility
- $130.3 million in money and money equivalents as of December 31, 2020
- In February 2021, Oncorus accomplished an underwritten public providing of widespread inventory, leading to combination gross proceeds of $57.0 million
- Firm anticipates continued development and progress in 2021 throughout its pipeline and enterprise, together with preliminary interim knowledge readout of ONCR-177 Part 1 scientific trial in second half of 2021
CAMBRIDGE, Mass., March 10, 2021 (GLOBE NEWSWIRE) — Oncorus, Inc. (Nasdaq:ONCR), a viral immunotherapies firm centered on driving innovation to rework outcomes for most cancers sufferers, at present reported fourth quarter and full yr 2020 monetary outcomes and supplied enterprise highlights.
“2020 was a yr of great evolution for Oncorus as we efficiently transitioned to a clinical-stage and publicly-traded firm,” mentioned Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Govt Officer of Oncorus. “Along with transferring our lead viral immunotherapy candidate, ONCR-177, right into a scientific trial, we continued to advance a number of pipeline candidates throughout our oncolytic Herpes Simplex Virus (oHSV) and Artificial Virus Platforms. We additionally started to plan operational and manufacturing scale-up to assist our anticipated development within the coming years.”
Dr. Ashburn continued, “Bolstered by a robust money place, we anticipate a number of milestones in 2021 that can additional advance Oncorus’ management within the viral immunotherapy house. These embrace the preliminary interim knowledge readout from our ongoing ONCR-177 scientific trial, the nomination of our first intravenously administered artificial virus scientific candidates in addition to our second intratumorally administered oHSV scientific candidate, and the completion of the primary buildout section of our GMP scientific manufacturing facility. We look ahead to continued development all through 2021, pushed by our mission to comprehend the total promise of viral immunotherapy for most cancers sufferers.”
Oncorus anticipates reporting interim knowledge from its ongoing Part 1 scientific trial of its lead oHSV-based scientific candidate ONCR-177 in sufferers with strong tumor indications within the second half of 2021 by the second half of 2022. The corporate plans to appoint its first artificial virus scientific candidates, coxsackievirus A21 and Seneca Valley Virus applications, within the first half of 2021 and its second oHSV scientific candidate, which is able to particularly goal mind most cancers, together with glioblastoma multiforme, within the second half of 2021.
Fourth Quarter and Full Yr 2020 and Current Highlights
- Just lately accomplished public providing of widespread inventory. In February 2021, Oncorus accomplished an underwritten public providing of widespread inventory, at a public providing value of $19.00 per share, elevating $57.0 million in combination gross proceeds.
- Introduced buildout of Good Manufacturing Apply (GMP) viral immunotherapy scientific manufacturing facility. In January 2021, Oncorus introduced the signing of a 15-year lease to construct a state-of-the-art, 88,000 sq. foot GMP viral immunotherapy scientific manufacturing facility in Andover, Mass. The power is meant to supply a complete answer for Oncorus’ Chemistry, Manufacturing and Controls (CMC) growth wants, enabling the manufacture, high quality, management and provide of clinical-grade viral immunotherapies for investigational new drug (IND)-enabling research and scientific research. Oncorus anticipates the primary section of the ability’s buildout can be accomplished in late 2021, together with course of growth and high quality management, with GMP multi-product manufacturing capabilities and full operation commencing in early 2023. Oncorus plans to proceed partnering with contract manufacturing organizations to supply extra assist and capability. The corporate expects to make use of as much as 100 Oncorus crew members on the website.
- Introduced publication of ONCR-177 preclinical knowledge demonstrating potent and sturdy antitumor exercise. In January 2021, Oncorus introduced the current publication of preclinical knowledge supporting the scientific growth of ONCR-177. Within the paper, entitled, “ONCR-177, an Oncolytic HSV-1 Designed to Potently Activate Systemic Antitumor Immunity” (Haines, et al., 2020), printed on-line within the journal Most cancers Immunology Analysis, ONCR-177 demonstrated potent and sturdy antitumor exercise in a number of immune-competent tumor fashions. The preclinical exercise of ONCR-177 was proven to be pushed by Oncorus’ distinctive mixture of 5 complementary immunomodulatory transgene payloads along with its retention of γ34.5. A herpes simplex virus 1 (HSV-1) gene, γ34.5 permits the virus to copy within the presence of host antiviral immune responses.
Fourth Quarter and Full Yr 2020 Highlights
- Appointed Steve Harbin as Chief Working Officer (COO) and Chief of Employees. In December 2020, Oncorus appointed Steve Harbin as COO and Chief of Employees, to guide planning and execution of its anticipated operational and manufacturing scale-up. Mr. Harbin brings greater than 30 years of numerous operational expertise in biotech, prescribed drugs and in-vitro diagnostics. His expertise consists of serving in a number of government committee roles at Moderna, Inc. for six years, the place he was a key driver of the corporate’s profitable development technique, overseeing scientific and non-clinical manufacturing operations, provide chain, services and human sources. Beforehand Mr. Harbin served as Senior Vice President, International Operations for France-based bioMérieux SA, and in addition held a number of management roles inside Eli Lilly and Firm globally.
- Expanded Board of Administrators with appointment of Scott Canute. In December 2020, Oncorus expanded its Board with the appointment of Scott Canute. Mr. Canute has practically 40 years of broad expertise within the biopharmaceutical business, together with main international manufacturing and operations technique and execution for Genzyme Company and Eli Lilly and Firm.
- Accomplished preliminary public providing. In October 2020, Oncorus accomplished the preliminary public providing of shares of its widespread inventory at a public providing value of $15.00 per share, and raised $98.4 million in combination gross proceeds, together with shares offered to the underwriters pursuant to a partial train of their choice to buy extra shares. On October 2, 2020, Oncorus’ widespread inventory commenced buying and selling on the Nasdaq International Market below the ticker image “ONCR”.
- Publication of preclinical knowledge characterizing ONCR-177’s security methods. In September 2020, ONCR-177’s security methods and their capacity to boost oHSV tolerability with out impeding efficiency have been characterised in a paper printed in Molecular Remedy on ONCR-159, the unarmed model of ONCR-177, titled, “Design of an Interferon-Resistant Oncolytic HSV-1 Incorporating Redundant Security Modalities for Improved Tolerability.” (Kennedy et al., 2020). Oncorus’ oHSV platform incorporates two complementary and proprietary security approaches, together with a microRNA attenuation technique to permit unencumbered viral replication in tumor cells whereas stopping replication in wholesome tissues, and engineered proprietary mutations into UL37 to remove the virus’ capacity to move, replicate and set up latency inside neurons.
- Introduced scientific trial collaboration with Merck. In July 2020, Oncorus entered right into a scientific trial collaboration and provide settlement with Merck (NYSE:MRK), referred to as MSD outdoors of the USA and Canada, by a subsidiary, to judge the mixture of ONCR-177 with KEYTRUDA® (pembrolizumab), as a part of the continued Part 1 scientific trial of ONCR-177 in grownup sufferers with superior and/or refractory cutaneous, subcutaneous or metastatic nodal strong tumors.
- Initiated Part 1 scientific trial of ONCR-177. In June 2020, Oncorus initiated a Part 1 scientific trial of its lead product candidate, ONCR-177, an intratumorally administered oHSV viral immunotherapy being developed for a number of strong tumor indications. The Part 1 open-label, multi-center, dose escalation and growth scientific trial is designed to judge the protection and tolerability of ONCR-177 and to find out the really useful Part 2 dose, in addition to its preliminary anti-tumor exercise, alone and together with Merck’s anti-PD-1 remedy, KEYTRUDA® (pembrolizumab), in sufferers with superior and/or refractory cutaneous, subcutaneous or metastatic nodal strong tumors. Oncorus anticipates reporting interim knowledge from the Part 1 scientific trial within the second half of 2021 by the second half of 2022.
Fourth Quarter Monetary Outcomes
- Money and money equivalents have been $130.3 million as of December 31, 2020 in comparison with $45.3 million as of December 31, 2019.
- Analysis and growth bills for the quarter ended December 31, 2020 have been $7.6 million in comparison with $5.9 million for the corresponding interval in 2019. The rise in analysis and growth bills was primarily attributable to will increase in scientific trial prices for the corporate’s Part 1 scientific trial in addition to elevated personnel-related bills pushed by elevated headcount.
- Basic and administrative bills for the quarter ended December 31, 2020 have been $4.0 million in comparison with $3.1 million for the corresponding interval in 2019. The rise basically and administrative bills was primarily attributable to will increase in personnel-related bills pushed by elevated headcount in addition to elevated prices related to the Firm’s transition to a public firm within the fourth quarter of 2020.
- Internet loss attributable to widespread stockholders for the quarter ended December 31, 2020 was $(11.8) million, or $(0.56) per share, in comparison with a internet loss attributable to widespread stockholders of $(11.5) million, or $(11.78) per share for a similar interval in 2019. The share and loss per share quantities within the fourth quarter of 2020 mirror the affect of the corporate’s IPO, which closed in October 2020.
Based mostly upon its present working plans and money and money equivalents at December 31, 2020, plus the web proceeds from the general public providing of widespread inventory in February 2021, the corporate expects to have adequate capital to fund its working bills and capital expenditure necessities into late 2023.
At Oncorus, we’re centered on driving innovation to ship next-generation viral immunotherapies to rework outcomes for most cancers sufferers. We’re advancing a portfolio of intratumorally and intravenously administered viral immunotherapies for a number of indications with important unmet wants based mostly on our oncolytic Herpes Simplex Virus (oHSV) Platform and Artificial Virus Platform. Designed to ship next-generation viral immunotherapy affect, our oHSV platform improves upon key traits of this therapeutic class to boost efficiency with out sacrificing security, together with higher capability to encode transgenes to drive systemic immunostimulatory exercise, retention of full replication competency to allow excessive tumor-killing efficiency, and orthogonal security methods to limit viral exercise to tumor cells. Our lead program, ONCR-177, is designed to be straight administered right into a tumor, leading to excessive native concentrations of the therapeutic agent, in addition to low systemic publicity to the remedy, which we consider might probably restrict systemic toxicities. Please go to www.oncorus.com to study extra.
Cautionary Word Concerning Ahead-Wanting Statements
This press launch accommodates forward-looking statements throughout the which means of the Personal Securities Litigation Reform Act of 1995, as amended, together with, with out limitation, implied and specific statements concerning the scientific growth of ONCR-177, together with expectations concerning timing for reporting knowledge from the continued Part 1 scientific trial, in addition to the product candidate’s therapeutic potential and scientific advantages; Oncorus’ expectations concerning upcoming milestones for its different potential product candidates, together with the timing for nomination of candidates from its two Artificial Virus Platform growth applications and its second oHSV Platform program, ONCR-GBM; expectations concerning the buildout timeline of its viral immunotherapy scientific manufacturing facility and its perception that its present money sources can be adequate to fund its operations into late 2023. The phrases “might,” “would possibly,” “will,” “might,” “would,” “ought to,” “count on,” “plan,” “anticipate,” “intend,” “consider,” “count on,” “estimate,” “search,” “predict,” “future,” “venture,” “potential,” “proceed,” “goal” and comparable phrases or expressions are supposed to determine forward-looking statements, though not all forward-looking statements include these figuring out phrases. Any forward-looking statements on this press launch are based mostly on administration’s present expectations and beliefs and are topic to numerous dangers, uncertainties and essential elements that will trigger precise occasions or outcomes to vary materially from these expressed or implied by any forward-looking statements contained on this press launch, together with, with out limitation, dangers related to: the affect of COVID-19 on Oncorus’ operations and the timing and anticipated outcomes of its ongoing and deliberate scientific trials; the chance that the outcomes of a scientific trial will not be predictive of future ends in reference to future scientific trials; Oncorus’ capacity to efficiently exhibit the protection and efficacy of ONCR-177 and procure regulatory approval; and Oncorus’ capacity to acquire, preserve and shield its mental property. These and different dangers and uncertainties are described in higher element within the part entitled “Threat Components” in Oncorus’ Annual Report on Kind 10-Okay for the yr ended December 31, 2020, to be filed with the Securities and Trade Fee on March 10, 2021, in addition to discussions of potential dangers, uncertainties, and different essential elements within the different filings that Oncorus makes with the Securities and Trade Fee on occasion. These paperwork can be found below the “SEC filings” web page of the Traders part of Oncorus’ web site at http://investors.oncorus.com.
Any forward-looking statements characterize Oncorus’ views solely as of the date of this press launch and shouldn’t be relied upon as representing its views as of any subsequent date. Oncorus explicitly disclaims any obligation to replace any forward-looking statements, whether or not because of new data, future occasions or in any other case. No representations or warranties (expressed or implied) are made in regards to the accuracy of any such forward-looking statements.
|Investor Contact:||Media Contact:|
|Alan Lada||Liz Melone|
|Solebury Trout||[email protected]|
|Condensed Consolidated Statements of Operations and Complete Loss|
|(in 1000’s, besides per share knowledge)|
|Three Months Ended||Yr Ended|
|December 31,||December 31,|
|Analysis and growth||$||7,593||$||5,864||$||27,153||$||24,047|
|Basic and administrative||3,968||3,141||10,000||7,119|
|Whole working bills||11,561||9,005||37,153||31,166|
|Loss from operations||(11,561||)||(9,005||)||(37,153||)||(31,166||)|
|Different earnings (expense):|
|Change in truthful worth of Collection B tranche rights||–||–||(11,256||)||–|
|Whole different earnings (expense), internet||(6||)||138||(11,146||)||462|
|Internet loss and complete loss||$||(11,567||)||$||(8,867||)||$||(48,299||)||$||(30,704||)|
|Accretion of low cost and dividends on redeemable convertible most well-liked inventory||(229||)||(2,678||)||(8,527||)||(4,287||)|
|Internet loss attributable to widespread stockholders||$||(11,796||)||$||(11,545||)||$||(56,826||)||$||(34,991||)|
|Internet loss per share – primary and diluted||$||(0.56||)||$||(11.78||)||$||(9.35||)||$||(37.42||)|
|Weighted-average variety of widespread shares – primary and diluted||21,126||980||6,080||935|
|Chosen Condensed Consolidated Stability Sheet Knowledge|
|December 31, 2020||December 31, 2019|
|Money and money equivalents||$||130,305||$||45,286|
|Working capital (1)||127,407||40,963|
|Proper-of-use asset (2)||41,372||–|
|Long run lease legal responsibility (2)||41,615||–|
|Redeemable convertible most well-liked inventory||–||116,632|
|Whole stockholders’ fairness (deficit)||$||134,664||$||(74,297||)|
(1) Working capital is outlined as present belongings much less present liabilities
(2) Displays the adoption of ASC 842, Leases, as of January 1, 2020 leading to capitalization of proper of use belongings and a corresponding legal responsibility for the Firm’s working leases