8-K
false000167181800016718182021-11-092021-11-09

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 09, 2021

 

 

ONCORUS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-39575

47-3779757

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

50 Hampshire Street

Suite 401

 

Cambridge, Massachusetts

 

02139

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (857) 320-6400

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, $0.0001 par value per share

 

ONCR

 

The NASDAQ Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 


Item 7.01 Regulation FD Disclosure.

On November 9, 2021, Oncorus, Inc. (the “Company”) issued a press release announcing details of its upcoming presentation at the Society for Immunotherapy of Cancer’s 2021 Annual Meeting and that it will host an upcoming investor call and webcast event to discuss initial data from its ongoing Phase 1 clinical trial of ONCR-177. The virtual event will take place on Friday, November 12, 2021 at 8:30 a.m., Eastern Time. The virtual event and related materials can be accessed via the Investors and Media section of the Company’s website and will be available for 30 days following the event. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation by reference language in such a filing, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

Exhibit Number

 

Description

 

 

 

99.1

 

Press release issued by Oncorus, Inc. on November 9, 2021

 

 

 

104

 

Cover Page Interactive Data File (embedded within the inline XBRL document)

 

 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

ONCORUS, INC.

 

 

 

 

Date:

November 9, 2021

By:

/s/ John McCabe

 

 

 

John McCabe
Chief Financial Officer

 


EX-99.1

https://cdn.kscope.io/d7686636188996d7bca49f19ffe2fe18-img130253335_0.jpg 

Exhibit 99.1

Oncorus Announces Details of Upcoming ONCR-177 Phase 1 Initial Clinical Data Presentation at the Society for Immunotherapy of Cancer’s (SITC) 2021 Annual Meeting

 

-- Company to host conference call and webcast on Friday, November 12, 2021 at 8:30 a.m. ET --

 

CAMBRIDGE, Mass., November 9, 2021 – Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapy company focused on driving innovation to transform outcomes for cancer patients, today announced details of its upcoming presentation of initial data from the ongoing Phase 1 dose escalation and expansion clinical trial of ONCR-177 at the upcoming Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting, taking place November 12–14, 2021 in Washington, D.C. and virtually. ONCR-177, Oncorus’ lead product candidate built on the company’s oncolytic Herpes Simplex Virus (HSV) platform, is an intratumorally administered viral immunotherapy being developed for the treatment of multiple solid tumor indications.

Poster Presentation Details:

Title: Initial results of a Phase 1 study of intratumoral ONCR-177, an oncolytic herpes-simplex virus-1 expressing five immunomodulatory transgenes, in subjects with advanced injectable tumors

Presenter: Jong Park, M.D., Instructor, Medicine, Harvard Medical School and Assistant, Medicine, Massachusetts General Hospital

Abstract #: 511

Location: Poster Hall at the Walter E. Washington Convention Center

Date and Time: November 12–14th from 7:00 a.m.– 8:30 p.m. ET

 

An e-version of the poster will be available on Oncorus’ website, in the Publications & Presentations section, as of 7:00 a.m. ET on Friday, November 12th.

 

The submitted abstract reflects a data cut-off date of June 28, 2021, whereas the poster presentation will reflect a data cut-off date of November 1, 2021. Additional data will be presented on several evaluable patients treated with ONCR-177 monotherapy at the recommended Phase 2 dose since the June cut-off date.

 

Conference Call and Webcast Information
Oncorus will host a conference call and live webcast with slides and Q&A on Friday, November 12th at 8:30 a.m. ET. Igor Puzanov, M.D., MSCI, FACP, who serves as Director of Center for Early Phase Clinical Trials, Senior Vice President of Clinical Investigations, and Chief of the Melanoma Section, at the Roswell Park Comprehensive Cancer Center in Buffalo, New York, will join Oncorus management for the call. Dr. Puzanov is also participating as an investigator in the ONCR-177 Phase 1 clinical trial.

 

To participate in the conference call, please dial (833) 614-1530 (domestic) or (520) 809-9930 (international) and refer to conference ID 8556488. A live webcast of the presentation will be available at https://investors.oncorus.com/. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Oncorus’ website for 30 days following the call.

 

 


 

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 (HSV) Platform and Synthetic viral RNA (vRNA) Immunotherapy Platform.

Designed to deliver next-generation viral immunotherapy impact, our HSV Platform improves upon key characteristics of this therapeutic class to enhance systemic activity. Our lead HSV 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 designed 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 clinical development of ONCR-177, including expectations regarding timing for reporting additional data from the ongoing Phase 1 clinical trial of ONCR-177, as well as the product candidate’s therapeutic potential and clinical benefits and the utility and potential of Oncorus’ HSV Platform. 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 risk that the results of preclinical studies and early results from clinical trials may not be predictive of future clinical trial results; the impact of COVID-19 on Oncorus’ operations and the timing and anticipated results of its ongoing and planned clinical trials; Oncorus’ ability to successfully demonstrate the safety, tolerability and efficacy of ONCR-177, ONCR-021 and ONCR-788, or any future product candidates, and obtain regulatory approval thereof; Oncorus’ ability to obtain the requisite components for its product candidates 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.

 

Media Contact:

Liz Melone

liz@scientpr.com

 

Investor Contact:

Stern Investor Relations

Julie Seidel

Julie.seidel@sternir.com