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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): December 15, 2022

 

 

 

Onconova Therapeutics, Inc.

(Exact name of Registrant as specified in its charter)

 

 

 

Delaware   001-36020   22-3627252
(State or Other Jurisdiction
of Incorporation or Organization)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)

 

12 Penns Trail

Newtown, PA 18940
(267) 759-3680

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

 

Not Applicable 

(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 (17CFR 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, par value $.01 per share   ONTX   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  o

 

 

 

 

 

  

Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

On December 15, 2022 the Board of Directors (the “Board”) of Onconova Therapeutics, Inc. (the “Company”) increased the size of the Board to eight members and, upon the recommendation of the Nominating and Corporate Governance Committee of the Board, elected Peter Atadja, Ph.D. and Trafford Clarke, Ph.D. as members of the Board, effective immediately. Dr. Atadja’s term and Dr. Clarke’s term will expire at the Company’s 2023 Annual Meeting of Stockholders.

 

The Board also has appointed Dr. Atadja as the Chairperson of the Nominating and Corporate Governance of the Board and Dr. Clarke as a member of the Compensation Committee of the Board.

 

As non-employee directors, each of Dr. Atadja and Dr. Clarke will receive cash and equity compensation paid by the Company pursuant to its non-employee director compensation program as described in the Company’s proxy statement, including a one-time grant of an option to purchase 100,000 shares of the Company’s common stock . There are no arrangements or understandings between Dr. Atadja and any other persons or Dr. Clarke and any other person pursuant to which each of them was selected as a director, and there are no transactions between Dr. Atadja and the Company or Dr. Clarke and the Company that would require disclosure under Item 404(a) of Regulation S-K. In addition, the Company will enter into indemnification agreements with Dr. Atadja and Dr. Clarke in connection with their appointment to the Board which will be in substantially the same form as that entered into with the other directors of the Company.

 

A copy of the Company’s press release announcing the appointments of Dr. Atadja and Dr. Clarke is attached as Exhibit 99.1.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.    
     
Exhibit No.   Exhibit
99.1   Press release issued by the Company dated December 19, 2022
104   The cover page from this Current Report on Form 8-K, formatted in Inline XBRL.

 

 

 

 

SIGNATURE

 

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

 

Dated: December 19, 2022Onconova Therapeutics, Inc.
   
 By: /s/ MARK GUERIN
  Name: Mark Guerin
  Title: Chief Operating Officer & Chief Financial Officer

 

 

 

 

Exhibit 99.1

 

Onconova Therapeutics Appoints Drs. Peter Atadja and Trafford Clarke to its Board of Directors

 

NEWTOWN, PA., December 19, 2022 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced the appointments of Peter Atadja, Ph.D., and Trafford Clarke, Ph.D., as independent members of the Company’s Board of Directors.

 

“It is my pleasure to welcome Peter and Trafford to our Board,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “Their track record of successfully building and leading teams tasked with the discovery, development, and delivery of novel therapies is impressive. I look forward to benefiting from their strategic counsel and expect their decades of experience in leadership roles at premier pharmaceutical companies will be invaluable as we work to efficiently advance our pipeline and execute on our corporate objectives.”

 

Dr. Atadja commented, “Joining Onconova’s Board is an honor and truly exciting opportunity. The Company’s lead asset, narazaciclib, has the potential to address unmet needs in a variety of cancers and overcome the limitations of currently approved CDK 4/6 inhibitors. The upcoming trial of narazaciclib plus letrozole in endometrial cancer is both well designed and supported by a robust clinical dataset providing proof-of-concept for narazaciclib’s differentiated mechanism of action in this indication. I am eager to begin working with my fellow Board members and the Company’s management team to advance its lead program and help guide rigosertib through investigator-sponsored trials.”

 

Dr. Clarke added, “I believe Onconova is well-positioned for sustained growth, as the Company is advancing differentiated, clinical-stage assets with a strong financial foundation and a talented team that has brought some of the most impactful oncology products to the clinic. I look forward to lending my insights to company management as they progress towards their goal of providing cancer patients with novel, best-in-class therapies that improve survival and quality of life.”

 

Dr. Atadja joins Onconova’s Board with over two decades of experience in the pharmaceutical industry. He is currently the Chief Scientific Officer (CSO) of CommBio Therapeutics, a biotechnology company dedicated to developing a new class of medicine for a spectrum of diseases by modulating intestinal functions. Prior to joining CommBio, Dr. Atadja co-founded and served as the CSO of K36 Therapeutics, a biotechnology company that aims to translate epigenetic modulation of oncogenic pathways into first-in-class small molecule therapeutics. From 1997 – 2021, Dr. Atadja held roles of increasing responsibility at Novartis Pharmaceuticals, most recently serving as the company’s Executive Director & Head, Drug Discovery & Translational Research. While at Novartis, he led the discovery, development, and registration of the first FDA and EMA approved HDAC inhibitor (FARYDAK®) and launched three major research programs (oncology, liver diseases, regenerative medicine), resulting in the addition of 20 novel targets, eight first-in-class candidates, and two clinical candidates to the company’s global pipeline. In 2008, Dr. Atadja was the Novartis VIVA Discovery Award Winner endowed with “Novartis Leading Scientist” title. He has a Ph.D. in molecular oncology from University of Calgary, a Master of Science in pharmaceutical and medicinal chemistry from Hebrew University, and a Bachelor of Pharmacy in medicinal chemistry from Kumasi University of Science and Technology, in Kumasi, Ghana.

 

 

 

 

Dr. Clarke is a pharmaceutical industry veteran who has dedicated his career to the discovery, development, and launch of new medicines. He spent 31 years working in roles of increasing responsibility at Eli Lilly and Company before retiring in 2017, most recently serving as a Managing Director and UK Research and Development Site Head from 2013 to 2017. In this role, Dr. Clarke led a team of approximately 700 people and oversaw site productivity, infrastructure investment, and ethics and compliance standards. In addition, from 2013 to 2017, as Eli Lilly’s European Federation of Pharmaceutical Industries and Associations R&D representative, Dr. Clarke was a member of the Research Directors Group and championed Lilly’s strategic engagement and leadership of 32 European Union Innovative Medicine Initiative projects. From 2013 to 2017, he served as Board Member for Eli Lilly and Company Ltd. UK and was a member of the Innovation Board of the Association of the British Pharmaceutical Industry. From 2020 to present, Dr. Clarke served as a mentor to student entrepreneurs at the MIT Sandbox Innovation Fund Program. Dr. Clarke has a Ph.D. in organic chemistry from Imperial College, London, and a Bachelor of Science in organic chemistry from University of Liverpool.

 

About Onconova Therapeutics, Inc.

 

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

 

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

 

Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

 

For more information, please visit www.onconova.com.

 

 

 

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," “preliminary,” “encouraging,” "approximately" or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova's clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading "Risk Factors" in Onconova's most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. 

 

Company Contact:

Mark Guerin

Onconova Therapeutics, Inc.

267-759-3680

ir@onconova.us

https://www.onconova.com/contact/

 

Investor Contact:

Bruce Mackle

LifeSci Advisors, LLC
646-889-1200

bmackle@lifesciadvisors.com