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Washington, DC 20549












Date of Report (Date of earliest event reported): November 14, 2023




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)
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  ¨





Item 2.02 Results of Operations and Financial Condition.


On November 14, 2023, Onconova Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and nine months ended September 30, 2023, a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference. The information contained in this Form 8-K (including the exhibit hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.


Item 9.01 Financial Statements and Exhibits.


(d) Exhibits.


Exhibit No.   Exhibit
99.1   Press release issued by the Company dated November 14, 2023
104   The cover page from this Current Report on Form 8-K, formatted in Inline XBRL.





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: November 14, 2023 Onconova Therapeutics, Inc.
    Name: Mark Guerin
    Title: Chief Operating Officer & Chief Financial Officer



Exhibit 99.1


Onconova Therapeutics Reports Corporate Update and Announces Third Quarter 2023 Financial Results


Narazaciclib progressing towards registrational studies; target engagement and acceptable safety profile support further dose escalation, affirming differentiated profile


Update on the registrational preparations for the narazaciclib program and the rigosertib trial plan expected in the first half of 2024


Company to host conference call and webcast at 4:30 p.m. ET on Tuesday, November 14, 2023


NEWTOWN, Pa., November 14, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today reported third quarter 2023 financial results and provided an update on recent pipeline progress. Management plans to host a conference call and live webcast at 4:30 p.m. ET today to discuss these results.


“Onconova has made excellent progress in the third quarter of 2023. Starting with our lead program, narazaciclib, a differentiated inhibitor of multiple kinases including CDK4/6, we advanced the registrational trial preparations in the first indication, for patients with low grade endometrioid endometrial cancer (LGEEC). CDK4/6 inhibitors have substantially changed the face of cancer care for the better and become a multibillion-dollar drug class. We believe narazaciclib has the potential to be differentiated by potently targeting proteins putatively involved in the resistance pathways of cancer cells that the approved agents fail to significantly inhibit,” said Steve Fruchtman, M.D., President and Chief Executive Officer.


Dr. Fruchtman continued, “We are seeing clinical and biological target engagement with narazaciclib and an acceptable safety profile at therapeutic dosing levels in the Phase 1/2 program. To date, we have not seen significant neutropenia and thus remain on target to deliver narazaciclib as a daily anti-cancer drug not requiring time off to permit marrow recovery, in contrast to the most commonly prescribed CDK4/6 inhibitor. In addition, to date, narazaciclib has not caused significant diarrhea, another limitation of other CDK4/6 inhibitors. Based on this profile, we have decided to dose escalate to at least one more cohort in each of the ongoing U.S. studies, to ensure that we achieve the optimal recommended Phase 2 dose. This may extend the Phase 1/2 program into the first quarter of 2024. We believe this is very good news for the program because it underscores the potential for narazaciclib to have a differentiated safety profile and wide therapeutic index.”


“From a corporate perspective, in the third quarter, we named Dr. Victor Moyo as Chief Medical Officer and Meena Arora as Vice-President, Global Medical Affairs & Research and Development, putting us on very solid footing to advance the clinical plan and regulatory strategy for narazaciclib and rigosertib. In addition, we continue to actively engage in a range of discussions related to partnering opportunities, to support the progression of our programs,” continued Dr. Fruchtman. “Finally, we progressed the development of a registrational study plan for rigosertib, our cell pathway inhibitor, for the ultra-rare indication of recessive dystrophic epidermolysis bullosa-associated squamous cell carcinoma (RDEB-associated SCC). These developments were complemented by impressive medical meeting presentations on both programs by our collaborators.”



Near Term Narazaciclib Milestones: Onconova intends to:


·present preclinical data at two December medical meetings: the San Antonio Breast Cancer Symposium (SABCS) and the annual meeting of the American Society of Hematology (ASH);

·continue the dose escalation segment of the Phase 1/2 program which may bring us into the first quarter of 2024;

·provide a read-out on narazaciclib’s safety and pharmacology in the first half of 2024;

·provide an update on our registrational trial-readiness over the next few quarters, including the definition of our recommended Phase 2 dose, engagement with the FDA on the pivotal trial design, and continuing to work with external clinical experts including the Gynecologic Oncology Group (GOG), and the European Network for Gynecologic Oncology Trials (ENGOT).


Achievement of these milestones will also enable us to establish a solid foundation to expand the program to include other indications such as breast cancer, ovarian cancer, and mantle cell lymphoma.


Rigosertib milestones: Onconova confirms plans to provide an update on the next steps to obtain orphan designation for rigosertib in RDEB-associated SCC and for the registrational program in the first half of 2024.


Second Quarter Financial Results


Cash and cash equivalents as of September 30, 2023, were $25.2 million, compared to $38.8 million as of December 31, 2022. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business into the third quarter of 2024.


Research and development expenses were $2.5 million for the third quarter of 2023, compared with $3.6 million for the second quarter of 2022.


General and administrative expenses were $2.7 million for the third quarter of 2023, compared with $2.1 million for the second quarter of 2022.


Net loss for the third quarter of 2023 was $4.7 million, or $0.23 per share on 21.0 million weighted average shares outstanding, compared with a net loss of $5.4 million, or $0.26 per share for the third quarter of 2022 on 20.9 million weighted average shares outstanding.


Conference Call and Webcast Information


Interested parties who wish to participate in the conference call may do so by dialing:


·(800) 715-9871 for domestic and

·(646) 307-1963 for international callers and

·Using conference ID 3238751


Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the Company's website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.


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’s product candidates, narazaciclib and rigosertib, are proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.


Narazaciclib, Onconova’s novel, multi-kinase inhibitor (formerly ON 123300), is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole, in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova believes narazaciclib has broad potential and is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications, including breast cancer, ovarian cancer and mantle cell lymphoma.



Rigosertib is being studied in an investigator-sponsored trial strategy to evaluate the product candidate in multiple indications, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237, NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).


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.





Investor Contact:

Bruce Mackle

LifeSci Advisors, LLC






Condensed Consolidated Balance Sheets


(in thousands)


   September 30,   December 31, 
   2023   2022 
Current assets:          
Cash and cash equivalents  $25,244   $38,757 
Receivables   18    29 
Prepaid expenses and other current assets   1,749    561 
Total current assets   27,011    39,347 
Property and equipment, net   26    24 
Other non-current assets   1    1 
Total assets  $27,038   $39,372 
Liabilities and stockholders' equity          
Current liabilities:          
Accounts payable  $6,148   $3,860 
Accrued expenses and other current liabilities   3,300    3,960 
Deferred revenue   226    226 
Total current liabilities   9,674    8,046 
Deferred revenue, non-current   2,847    3,017 
Total liabilities   12,521    11,063 
Stockholders' equity:          
Preferred stock   -    - 
Common stock   210    209 
Additional paid in capital   492,784    491,816 
Accumulated other comprehensive loss   (30)   (33)
Accumulated deficit   (478,447)   (463,683)
Total stockholders' equity   14,517    28,309 
Total liabilities and stockholders' equity  $27,038   $39,372 





Condensed Consolidated Statements of Operations (unaudited)


(in thousands, except share and per share amounts)


   Three Months Ended September 30,   Nine Months Ended September 30, 
   2023   2022   2023   2022 
Revenue  $57   $57   $170   $170 
Operating expenses:                    
General and administrative   2,686    2,105    7,010    6,430 
Research and development   2,460    3,593    8,996    7,633 
Total operating expenses   5,146    5,698    16,006    14,063 
Loss from operations   (5,089)   (5,641)   (15,836)   (13,893)
Other income, net   350    243    1,072    349 
Net loss   (4,739)   (5,398)   (14,764)   (13,544)
Net loss per share of common stock, basic and diluted  $(0.23)  $(0.26)  $(0.70)  $(0.65)
Basic and diluted weighted average shares outstanding   21,002,937    20,915,408    20,981,097    20,920,251