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Total Assets	22.68M
Total Liability	12.01M
Assets-to-Libability Ratio	1.89

Total Current Assets	22.66M
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News

Onconova Therapeutics to Present at NobleCon19, Noble Capital Markets’ Nineteenth Annual Emerging Growth Equity ConferenceNEWTOWN, Pa., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Steven Fruchtman, M.D., President ...
NEWTOWN, Pa., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Steven Fruchtman, M.D., President & CEO, will present at NobleCon19, Noble Capital Markets’ Nineteenth Annual Emerging Growth Equity Conference, being held December 3-5, 2023 at Florida Atlantic University, Executive Education Complex, in Boca Raton, FL. Presentation Details Date/Time:Monday, December 4, 2023, 10:30 AM ET followed by a Breakout SessionSpeaker:Steven Fruchtman, M.D., President & CEO1X1 meetings:The Onconova Management Team will be available for 1X1 meetings during the conference. Those interested in requesting a meeting should contact their Noble Capital Markets representative. A webcast of the presentation will be available the following day on the “Corporate Events and Presentations” section of the Onconova website, and as part of a complete catalog of presentations available at Noble Capital Markets’ Conference website www.nobleconference.com, and on Channelchek www.channelchek.com. The webcast will be archived on the Onconova website, the NobleCon website, and on Channelchek.com for 90 days following the event. 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. 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
ONTX | globenewswire | about 2 years ago | Neutral

Onconova Therapeutics Reports Corporate Update and Announces Third Quarter 2023 Financial ResultsNarazaciclib 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 ...
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., Nov. 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 meetingpresentations 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 andUsing 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. 267-759-3680 ir@onconova.us https://www.onconova.com/contact/ Investor Contact: Bruce Mackle LifeSci Advisors, LLC 646-889-1200 bmackle@lifesciadvisors.com ONCONOVA THERAPEUTICS, INC.Condensed Consolidated Balance Sheets(in thousands) September 30, December 31, 2023 2022Assets(unaudited) 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 ONCONOVA THERAPEUTICS, INC. 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
ONTX | globenewswire | about 2 years ago | Neutral

Onconova Therapeutics to Provide Corporate Update and Announce Third Quarter 2023 Financial Results on November 14, 2023NEWTOWN, Pa., Nov. 07, 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 announced that the Company intends to release i...
NEWTOWN, Pa., Nov. 07, 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 announced that the Company intends to release its third quarter 2023 financial results on Tuesday, November 14, 2023. Management plans to host a conference call and live webcast at 4:30 p.m. ET on the same day to discuss these results and provide an update on its pipeline programs. 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 or(646) 307-1963 for international callers andUsing conference ID 3238751 Those interested in listening to the conference call via the internet may do so by visiting the Upcoming Events investors and media page on the Company's website at www.onconova.com or by clicking on this webcast link just prior to the event. 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. 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. 267-759-3680 ir@onconova.us https://www.onconova.com/contact/ Investor Contact: Bruce Mackle LifeSci Advisors, LLC 646-889-1200 bmackle@lifesciadvisors.com
ONTX | globenewswire | about 2 years ago | Neutral

Onconova Therapeutics’ ASH Poster To Focus on Narazaciclib in MCLPreclinical data indicate that narazaciclib shows monotherapy and combination anti-tumor activity in ibrutinib-sensitive and resistant cells and xenograft models NEWTOWN, Pa., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-s...
Preclinical data indicate that narazaciclib shows monotherapy and combination anti-tumor activity in ibrutinib-sensitive and resistant cells and xenograft models NEWTOWN, Pa., Nov. 02, 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 announced that Onconova and collaborators will present a preclinical poster related to its lead program, narazaciclib, at the 65th American Society for Hematology Annual Meeting & Exposition (ASH), taking place in San Diego, California from December 9 to 12, 2023. “The poster that we and researchers from the Josep Carreras Leukaemia Research Institute in Barcelona, Spain are presenting at ASH 2023 shows that the study of narazaciclib, either as a single agent or in combination with ibrutinib, effectively controls tumor growth in preclinical models of mantle cell lymphoma (MCL), including those that are resistant to Bruton’s tyrosine kinase inhibitors (BTKis), a mainstay of care for this aggressive and difficult to treat cancer. The experiments included a broad comparison of narazaciclib with three other approved cyclin-D-kinase inhibitors (CDKis), used in combination with several BTKis,” said Steven Fruchtman, M.D., President and CEO of Onconova. Dr. Fruchtman continued, “We were especially pleased by the broad translational data set that provided an understanding of narazaciclib’s role in cell cycle blockade. These studies show that narazaciclib appears to act in the G1 phase of the cell cycle. Furthermore, the studies also indicate that the combination of narazaciclib and ibrutinib act in a synergistic way to achieve in vitro and in vivo anti-tumor activity in ibrutinib sensitive- and resistant -cells and xenograft models. Together, these data support the potential use of narazaciclib in MCL and other cyclin-dependent indications, and further inform our understanding of narazaciclib’s mechanism of action as we advance the clinical program, led by the Phase 1/2a study in patients with low grade endometrioid endometrial cancer, an indication with a great unmet medical need.” Poster Presentation Information: Title: Narazaciclib, a Differentiated CDK4/6 Antagonist, Prolongs Cell Cycle Arrest and Metabolomic Reprogramming, Enabling Restoration of Ibrutinib Sensitivity in Btki-Resistant Mantle Cell Lymphoma Session Name: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster III Session Date: Monday, December 11, 2023 Presentation Time: 6:00 PM - 8:00 PM PT Location: San Diego Convention Center, Halls G-H Poster Number: 4181 Presenters: Dr. Nuria Profitos-Peleja, Lymphoma Translational Group, Josep Carreras Leukaemia Research Institute, Barcelona, Spain 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. 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. 267-759-3680 ir@onconova.us https://www.onconova.com/contact/ Investor Contact: Bruce Mackle LifeSci Advisors, LLC 646-889-1200 bmackle@lifesciadvisors.com
ONTX | globenewswire | about 2 years ago | Neutral

Onconova Expands Leadership Team with Two Key AppointmentsDr. Victor Moyo named Chief Medical Officer Meena Arora joins as Vice President Global Medical Affairs and R&D NEWTOWN, Pa., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering...
Dr. Victor Moyo named Chief Medical Officer Meena Arora joins as Vice President Global Medical Affairs and R&D NEWTOWN, Pa., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company expanded its leadership team with the naming of Dr. Victor Moyo as Chief Medical Officer (CMO), and the addition of Meena Arora as Vice President, Global Medical Affairs and Research and Development (R&D). “We are delighted to have Dr. Moyo and Ms. Arora as integral members of our team at Onconova as we prepare to enter the next phase of development for narazaciclib and rigosertib, our novel and proprietary cell pathway inhibitors for oncology,” said Dr. Steven Fruchtman, President and Chief Executive Officer (CEO). Both are accomplished experts in their fields and bring significant and wide expertise in drug development. I believe Victor’s extensive track record as a clinical researcher and drug developer in oncology and Meena’s unique medical affairs expertise in rare diseases and oncology will be instrumental to the Company’s success as we advance the clinical plan and regulatory strategy for each program.” Victor Moyo commented, “I am very pleased to be named as Onconova’s Chief Medical Officer. Working with the team over the last quarter has given me the opportunity to appreciate the potential for Onconova’s product pipeline, especially the excellent work that the Company has done differentiating narazaciclib from other CDK4/6 inhibitors. I believe narazaciclib holds the promise of prolonging progression in patients with endometrial and other gynecological cancers as well as hematologic malignancies in indications where there is still an unmet medical need. I look forward to working with my colleagues at Onconova and our clinical collaborators to contribute to our mission of bringing narazaciclib and rigosertib to patients with cancer. Meena Arora shared, “I am excited to join Onconova’s talented and experienced group of professionals and look forward to beginning my tenure as Vice President Global Medical Affairs and Research and Development to execute on Onconova’s vision. I joined the Company because I believe that our oncology programs are based on impressive science and preliminary clinical results and are focused on important indications where there is a need for improved clinical outcomes. I am excited to couple my expertise in rare disease and oncology with my dedicated experience in medical and regulatory affairs and research and development strategy to help advance Onconova’s potential priority therapies for people with cancer.” Dr. Moyo is a highly experienced physician researcher and drug developer, with extensive clinical research pharmaceutical industry experience. He has held a variety of senior leadership positions with responsibility for a number of clinical development plans, IND filings, NDA filings, post-market development plans, notably including his work on such programs as Onivyde® for metastatic pancreatic cancer, epoetin alpha trial in myelodysplastic syndrome, and the Doxil® trial in advanced ovarian cancer. He is also a named inventor on numerous granted patents and patent applications. Dr. Moyo joined Onconova as Consulting Chief Medical Officer in August, 2023. He has also held various leadership roles as Vice President of Clinical Investigations at Merrimack Pharmaceuticals and the Centocor Ortho Biotech Services, LLC division of Johnson & Johnson. Dr. Moyo earned his M.D. from the University of Zimbabwe. Following his move to the U.S., he went on to complete his internship and residency in Internal Medicine at the George Washington School of Medicine and Health Sciences and his fellowship in Hematology and Oncology at the Johns Hopkins University School of Medicine Meena Arora is a highly credentialed executive with experience in both pharmaceutical and emerging biotechnology companies, working in roles of increasing responsibility in medical affairs, regulatory strategy and scientific leadership in oncology, rare disease immunology, and inflammation. Over the course of her career, she has worked on development programs for notable products including Filsuvez®, Revlimid®, Imnovid®, Abraxane®, Vidaza® and CAR-T cell therapy (Breyanzi® and Abecma®). Most recently, Ms. Arora served as Vice President/Head of Global Medical Affairs – Epidermolysis Bullosa (EB) for Amryt Pharma. Prior to that, she held various leadership roles as Medical Director or Associate Medical Director, as well as roles in Investigator Research and Medical Affairs at Celgene International. Ms. Arora has also held multiple advancing roles in medical and commercial development at GlaxoSmithKline and SmithKline Beecham. Ms Arora earned degrees in Pharmaceutical Science, Pharmaceutical Medicine and Biomedical Science with a Master of Science in Drug Development Science with studies in Biotechnology and Advanced Therapeutics from Kings College London and a Post Graduate Diploma in Pharmaceutical Medicine/Clinical Research from the University of Surrey. Ms. Arora received a Chartered Institute of Marketing Advanced Diploma from Cambridge Marketing College and earned a Post Graduate Diploma in Pharmaceutical Science and Bachelor of Science (Hons) in Biomedical Science from the Nottingham Trent University. Ms Arora is the recipient of multiple industry awards and publication co-author. 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. 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. 267-759-3680 ir@onconova.us https://www.onconova.com/contact/ Investor Contact: Bruce Mackle LifeSci Advisors, LLC 646-889-1200 bmackle@lifesciadvisors.com
ONTX | globenewswire | about 2 years ago | Neutral

Promising Preclinical Narazaciclib Data Presented at MCL MeetingData for Mantle cell lymphoma (MCL) presented in Ireland on Oct. 7, 2023 Additional studies support broad potential, especially in cyclin-dependent cancers NEWTOWN, Pa., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage bi...
Data for Mantle cell lymphoma (MCL) presented in Ireland on Oct. 7, 2023 Additional studies support broad potential, especially in cyclin-dependent cancers NEWTOWN, Pa., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that one of the Company’s scientific collaborators, Gaël Roué, Ph.D., from the Josep Carreras Leukaemia Research Institute, Spain, made a podium presentation during the European MCL Network Annual Meeting in Dublin, Ireland on October 7, 2023 regarding promising ongoing preclinical studies of narazaciclib, in combination with ibrutinib and other targeted therapies used in the treatment for mantle cell lymphoma. “Mantle cell lymphoma (MCL) is an aggressive and devastating disease, marked by frequent relapses and poor prognosis. The biology of MCL is very interesting to Onconova because of the link to cyclin D1 (CD1) overexpression. Onconova’s proprietary multi-kinase inhibitor, narazaciclib, has nanomolar potency across a range of targets including CD1. We believe this molecular feature could make MCL amenable to treatment combinations that include narazaciclib,” said Steven Fruchtman, M.D., President and CEO of Onconova. “Dr. Roué’s recent work expands the dataset regarding the potential use of narazaciclib in combination with ibrutinib and other targeted therapies in sensitive and resistant MCL cell lines. Together, these data provide a foundation of support for using narazaciclib in MCL and other cyclin-dependent indications. We look forward to incorporating these important findings into the development plan for narazaciclib as we advance the clinical program, led by the Phase 1/2a study in patients with LGEEC.” Onconova plans to provide an update on the Phase 1/2a clinical program with narazaciclib in patients with low grade endometriod endometrial cancer (LGEEC), including topline safety, pharmacology data, and selection of a recommended Phase 2 dose, in Q4 2023. Data featured in the presentation in Dublin and in a prior presentation at the American Association for Cancer Research (AACR) Annual Meeting in April of 2023 outlined promising results from preclinical studies that compared combinations of narazaciclib and other approved CDK4/6 inhibitors with ibrutinib and other next-generation BTK inhibitors to assess potential treatment synergies. Data from the combination of narazaciclib and ibrutinib showed significant synergistic anti-tumor activity in both sensitive and ibrutinib-resistant MCL models. 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. 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. 267-759-3680 ir@onconova.us https://www.onconova.com/contact/ Investor Contact: Bruce Mackle LifeSci Advisors, LLC 646-889-1200 bmackle@lifesciadvisors.com
ONTX | globenewswire | about 2 years ago | Neutral

Encouraging Rigosertib Data Presented at EADV as Late BreakerNEWTOWN, Pa., Oct. 12, 2023 (GLOBE NEWSWIRE) -- (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that a late-breakin...
NEWTOWN, Pa., Oct. 12, 2023 (GLOBE NEWSWIRE) -- (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that a late-breaking abstract studying rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB), associated with advanced/metastatic squamous cell carcinoma (SCC), will be presented today in the Late Breaking News session at the European Academy of Dermatology and Venereology (EADV) in Berlin, Germany, by Professor Dr. Johann Bauer, from the University Hospital Salzburg, Dermatology and Allergology of the PMU, Salzburg, Austria, an Investigator on the investigator-led study (IST). “RDEB-associated SCC is a devastating disease with few if any treatment options for advanced patients. We are very pleased for additional data on the potential use of rigosertib in patients with RDEB-associated SCC to be presented as a ‘late breaker’ at EADV 2023,” said Steven Fruchtman, M.D., President and CEO of Onconova. “We believe that rigosertib’s profile and impact on key cell signaling pathway targets, including PLK-1 kinase, could make rigosertib a very attractive approach for this indication and other cancers. We are employing an “investigator-sponsored trial” strategy to evaluate rigosertib and believe the data that are being presented at EADV 2023 highlight the potential clinical utility of the compound.” Professor Bauer commented, “I have been working with patients and their families affected by RDEB and the devastating sequalae of squamous cell carcinoma. I am pleased to share the initial encouraging patient experience with rigosertib at this conference. We are keen to further enroll other potential patients on this study.” Presentation Details Date:Thursday, October 12, 2023Time:4:00 to 4:15 p.m. in Germany/10:00 to 10:15 a.m. ETAbstract Title:Efficacy and Safety of Rigosertib in Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB) Associated Advanced/Metastatic Squamous Cell Carcinoma (SCC)Presenter:Prof. Dr. Johann Bauer, M.D., MBASession:D2T01.3: Late breaking news Abstract Details The abstract outlines promising results from an open-label, single arm safety and efficacy study of four patients with recessive dystrophic epidermolysis bullosa (RDEB) associated advanced/metastatic squamous cell carcinoma (SCC) treated with intravenous/IV or oral rigosertib. Two patients achieved complete cutaneous responses of 12 months or more, one patient experienced metastatic disease progression, and one patient remains on study. Responding patients included one patient who achieved both cutaneous and histological remission of 16 months. The patient’s rigosertib dose was reduced following the report of a grade 2 adverse event (irritative cystitis), which led to symptomatic relief. The other responding patient achieved a complete cutaneous remission and completed the protocol-specified 12-months of therapy. The authors suggest that the preliminary study results indicate rigosertib as a potential treatment for RDEB-associated SCC. Additional patients are being sought for the trial. A copy of the Abstract will be available on the Scientific Presentations section of the Onconova website following the Presentation. 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. 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. 267-759-3680 ir@onconova.us https://www.onconova.com/contact/ Investor Contact: Bruce Mackle LifeSci Advisors, LLC 646-889-1200 bmackle@lifesciadvisors.com
ONTX | globenewswire | about 2 years ago | Neutral

Onconova Therapeutics to Present a Late-Breaking Abstract on Rigosertib at the 2023 EADV CongressNEWTOWN, Pa., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that a late-breaking abstract reportin...
NEWTOWN, Pa., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that a late-breaking abstract reporting the use of rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB) associated with advanced/metastatic squamous cell carcinoma (SCC) will be presented in the Late Breaking News session at the European Academy of Dermatology and Venereology (EADV) 2023 Congress taking place October 11-14 in Berlin, Germany. Presentation Details Date: Thursday, October 12, 2023 Time:4:00-4:15 p.m. in Germany / 10:00-10:15 a.m. ET Abstract Title:Efficacy and Safety of Rigosertib in Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB) Associated Advanced/Metastatic Squamous Cell Carcinoma (SCC) Presenter:Prof. Dr. Johann Bauer, MD University Hospital Salzburg Session:D2T01.3: Late breaking news 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. 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. 267-759-3680 ir@onconova.us https://www.onconova.com/contact/ Investor Contact: Bruce Mackle LifeSci Advisors, LLC 646-889-1200 bmackle@lifesciadvisors.com
ONTX | globenewswire | about 2 years ago | Neutral

Onconova Therapeutics to Participate at the H.C. Wainwright 25th Annual Global Investment ConferenceNEWTOWN, Pa., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Steven Fruchtman, M.D., President...
NEWTOWN, Pa., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Steven Fruchtman, M.D., President & CEO, will participate in the H.C. Wainwright 25th Annual Global Investment Conference being held September 11-13, 2023. Presentation Details Date/Time: Monday, September 11, 2023, available on-line beginning at 7:00 AM ETSpeaker:Steven Fruchtman, M.D., President & CEOInvestor Access:Webcast Link1X1 meetingsThe Onconova Management Team will be available for 1X1 meetings during the conference. Those interested in requesting a meeting should contact their H.C. Wainwright representative. The presentation can be viewed here or on the “Corporate Events and Presentations” section of the Onconova website and will be archived for 90 days. 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 include 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 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 is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies, 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. 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
ONTX | globenewswire | about 2 years ago | Neutral

Onconova Therapeutics Reports Corporate Update and Announces Second Quarter 2023 Financial ResultsAnticipate topline results from the Phase 1 monotherapy and Phase 1/2 combination study with letrozole in Q4 2023 Plans are underway for a registrational trial with rigosertib in patients with RDEB-associated squamous cell carcinoma based on a constructive Type B FDA meeting held in June Company t...
Anticipate topline results from the Phase 1 monotherapy and Phase 1/2 combination study with letrozole in Q4 2023 Plans are underway for a registrational trial with rigosertib in patients with RDEB-associated squamous cell carcinoma based on a constructive Type B FDA meeting held in June Company to host conference call and webcast at 4:30 p.m. ET on Thursday, August 10, 2023 NEWTOWN, Pa., Aug. 10, 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 second 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. “We are very encouraged about the recent progress that the Onconova team has made for our two lead programs, narazaciclib, a differentiated multikinase CDK4/6 inhibitor targeting proteins involved in resistance pathways, and rigosertib, a cell signaling inhibitor, over the last few months, while effectively managing our financial resources. In addition, we are pleased that Victor Moyo, M.D., a highly experienced and successful clinical researcher and drug developer, has agreed to join the Company as Consulting Chief Medical Officer. We look forward to sharing several important updates in the coming months,” said Steve Fruchtman, M.D., President and Chief Executive Officer. Dr. Fruchtman continued, “For narazaciclib, our efforts have been dedicated to completing a Phase 1 program and defining a recommended Phase 2 dose to support evaluation of narazaciclib in a randomized trial. Onconova believes this CDK4/6 compound has the potential to provide differentiated efficacy based on targeting proteins that have been implicated in resistance mechanisms and the potential for an improved safety profile. We are pleased to see target engagement based on an assay measuring proliferation. We expect to report the results from our Phase 1 monotherapy and Phase 1/2 combination study with letrozole in Q4 2023. The readout will include safety, pharmacokinetics and the definition of a recommended Phase 2 dose.” Dr. Fruchtman concluded, “For rigosertib, we continue to believe this rigosertib’s unique action on cell signaling pathways, including K-RAS and PLK-1, combined with an acceptable safety profile, could position it as an attractive anti-cancer agent. In June, we had a constructive Type B meeting with the FDA for the use of rigosertib monotherapy in the lead, ultra-rare indication of RDEB-associated squamous cell carcinoma. Based on that meeting and the impressive clinical responses in previously refractory patients we have seen and presented at major medical meetings, we plan to design a registrational trial and will look to provide an update on next steps in H1 2024. In the meantime, we continue to support two investigator sponsored studies for rigosertib, underway in melanoma and KRAS mutated non-small cell lung cancer which includes any KRAS mutation that may be present.” Second Quarter Financial Results Cash and cash equivalents as of June 30, 2023, were $29.7 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 second quarter of 2024. Research and development expenses were $2.5 million for the second quarter of 2023, compared with $2.0 million for the second quarter of 2022. General and administrative expenses were $2.2 million for the second quarter of 2023, compared with $2.1 million for the second quarter of 2022. Net loss for the second quarter of 2023 was $4.3 million, or $0.20 per share on 21.0 million weighted shares outstanding, compared with a net loss of $4.0 million, or $0.19 per share for the second quarter of 2022 on 20.9 million weighted 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 andUsing conference ID 9506701 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 include 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 a Phase 1/2 combination trial with the estrogen blocker, letrozole, in advanced low grade endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include 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 and 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-sponsored trials, 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 ONCONOVA THERAPEUTICS, INC. Condensed Consolidated Balance Sheets (in thousands) June 30, December 31, 2023 2022 Assets(unaudited) Current assets: Cash and cash equivalents$29,729 $38,757 Receivables 17 29 Prepaid expenses and other current assets 704 561 Total current assets 30,450 39,347 Property and equipment, net 17 24 Other non-current assets 1 1 Total assets$30,468 $39,372 Liabilities and stockholders' equity Current liabilities: Accounts payable$5,071 $3,860 Accrued expenses and other current liabilities 3,369 3,960 Deferred revenue 226 226 Total current liabilities 8,666 8,046 Deferred revenue, non-current 2,904 3,017 Total liabilities 11,570 11,063 Stockholders' equity: Preferred stock - - Common stock 210 209 Additional paid in capital 492,424 491,816 Accumulated other comprehensive loss (28) (33)Accumulated deficit (473,708) (463,683)Total stockholders' equity 18,898 28,309 Total liabilities and stockholders' equity$30,468 $39,372 ONCONOVA THERAPEUTICS, INC.Condensed Consolidated Statements of Operations (unaudited)(in thousands, except share and per share amounts) Three Months Ended June 30, Six months months ended June 30, 2023 2022 2023 2022 Revenue$57 $57 $113 $113 Operating expenses: General and administrative 2,211 2,139 4,324 4,325 Research and development 2,456 2,038 6,536 4,040 Total operating expenses 4,667 4,177 10,860 8,365 Loss from operations (4,610) (4,120) (10,747) (8,252) Change in fair value of warrant liability - - - - Other income, net 360 96 722 106 Net loss (4,250) (4,024) (10,025) (8,146)Net loss per share of common stock, basic and diluted$(0.20) $(0.19) $(0.48) $(0.39)Basic and diluted weighted average shares outstanding 20,979,766 20,904,085 20,970,022 20,904,085
ONTX | globenewswire | about 2 years ago | Neutral

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Onconova Therapeutics Inc (ONTX)

Onconova Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on discovering and developing novel products to treat cancer in the United States. It has two clinical-stage programs, including narazaciclib, a multi-targeted kinase inhibitor that is in Phase I study for solid tumors, as well as hematological malignancies as a single agent or in combination with other anti-cancer therapies; and oral rigosertib alone or in combination with PD-1 inhibitor, which is in Phase I/IIa study for the treatment of progressive K-Ras mutated non-small cell lung cancer. The company also conducting a Phase II investigator-initiated study with rigosertib monotherapy in patients with advanced/metastatic squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa. It has a license and collaboration agreement with HanX Biopharmaceuticals, Inc. for the development, registration, and commercialization of narazaciclib in China. Onconova Therapeutics, Inc. was incorporated in 1998 and is headquartered in Newtown, Pennsylvania.

Exchange: NASDAQ

IPO Date: 7/25/2013

Sector: Healthcare

Industry: Biotechnology

Employees: 16

Address: 12 Penns Trail, Newtown, PA, United States, 18940

https://www.onconova.com

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