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NEWTOWN, Pa., May 15, 2023 (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 financial results for the three months ended March 31, 2023, and provided a business update.
Highlights for the first quarter of 2023 and recent weeks include:
Management Commentary
“Recent progress has us approaching important clinical and regulatory milestones expected later this year,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “We recently dosed the first participant in our Phase 1/2a trial of narazaciclib plus letrozole in recurrent metastatic LGEEC. This trial is supported by prior clinical data providing proof-of-concept for the studied doublet’s mechanism of action, as well as preclinical and Phase 1 results that suggest narazaciclib can overcome the shortcomings of the off-label agents current combined with letrozole to treat this indication. Collectively, these data fuel our enthusiasm for the program as we advance towards a preliminary data readout expected in the fourth quarter.”
Dr. Fruchtman continued, “In rigosertib’s RDEB-associated SCC program, we have requested a Type B meeting to discuss our encouraging clinical data with the FDA and expect to provide an important regulatory update following the meeting. Though from a small number of patients, these data have far exceeded our expectations, with both of the program’s participants achieving durable, complete clinical responses of all cancerous skin lesions on rigosertib monotherapy. Given the strength of these data, the ultra-rare nature of RDEB-associated SCC, and the stark limitations of currently available therapies, we are committed to working with the agency to determine the best, most expeditious path towards a potential approval.”
First Quarter Financial Results
Cash and cash equivalents as of March 31, 2023 were $34.2 million compared with $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 operations into the first quarter of 2024.
Research and development expenses were $4.1 million for the first quarter of 2023, compared with $2.0 million for the first quarter of 2022.
General and administrative expenses were $2.1 million for the first quarter of 2023, compared with $2.2 million for the first quarter of 2022.
Net loss for the first quarter of 2023 was $5.8 million, or $0.28 per share on 20.9 million weighted shares outstanding, compared with a net loss of $4.1 million, or $0.20 per share for the first quarter of 2022 on 20.9 million weighted shares outstanding.
Conference Call and Webcast
Onconova will host an investment community conference call beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for the first quarter of 2023, provide a business update, and answer questions. Interested parties can participate by dialing (800) 715-9871 (domestic callers) or (646) 307-1963 (international callers) and using conference ID 9090989.
A live webcast of the conference call will be available in the Investors & Media section of the Company's website at www.onconova.com. A replay of the webcast 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 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 a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib 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, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and in advanced malignant melanoma.
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) | |||||||
| March 31, | December 31, | ||||||
| 2023 | 2022 | ||||||
| Assets | (unaudited) | ||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 34,220 | $ | 38,757 | |||
| Receivables | 17 | 29 | |||||
| Prepaid expenses and other current assets | 802 | 561 | |||||
| Total current assets | 35,039 | 39,347 | |||||
| Property and equipment, net | 21 | 24 | |||||
| Other non-current assets | 1 | 1 | |||||
| Total assets | $ | 35,061 | $ | 39,372 | |||
| Liabilities and stockholders' equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 4,896 | $ | 3,860 | |||
| Accrued expenses and other current liabilities | 4,103 | 3,960 | |||||
| Deferred revenue | 226 | 226 | |||||
| Total current liabilities | 9,225 | 8,046 | |||||
| Deferred revenue, non-current | 2,960 | 3,017 | |||||
| Total liabilities | 12,185 | 11,063 | |||||
| Stockholders' equity: | |||||||
| Preferred stock | - | - | |||||
| Common stock | 210 | 209 | |||||
| Additional paid in capital | 492,151 | 491,816 | |||||
| Accumulated other comprehensive loss | (27 | ) | (33 | ) | |||
| Accumulated deficit | (469,458 | ) | (463,683 | ) | |||
| Total stockholders' equity | 22,876 | 28,309 | |||||
| Total liabilities and stockholders' equity | $ | 35,061 | $ | 39,372 | |||
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except share and per share amounts)
| Three months ended March 31, | |||||||
| 2022 | 2022 | ||||||
| Revenue | $ | 56 | $ | 56 | |||
| Operating expenses: | |||||||
| General and administrative | 2,113 | 2,186 | |||||
| Research and development. | 4,080 | 2,002 | |||||
| Total operating expenses | 6,193 | 4,188 | |||||
| Loss from operations | (6,137 | ) | (4,132 | ) | |||
| Change in fair value of warrant liability | --- | --- | |||||
| Other income, net | 362 | 10 | |||||
| Net loss | (5,775 | ) | (4,122 | ) | |||
| Net loss per share of common stock, basic and diluted | $ | (0.28 | ) | $ | (0.20 | ) | |
| Basic and diluted weighted average shares outstanding | 20,960,171 | 20,904,085 | |||||