Full Press Release Details
Onconova Therapeutics
Reports Full Year 2021 Financial Results and
Provides Business Update
and live webcast at 4:30 p.m. ET today
March 17, 2022 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova"), a clinical-stage
biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced financial results
for the twelve months ended December 31, 2021, and provided a business update.
the fourth quarter of 2021 and recent weeks include:
made across our pipeline over the past months have us on track for an exciting 2022," said Steven M. Fruchtman, M.D., President
and Chief Executive Officer of Onconova. "We continue to be pleased with the safety findings from narazaciclib's ongoing
Phase 1 program and remain on track to identify a recommended Phase 2 dose in the second half of the year. Narazaciclib shows low nanomolar
activity against kinases associated with tumor growth, metastasis, and potentially drug resistance, which differentiates it from currently
approved CDK 4/6 inhibitors. We thus believe it may have broad therapeutic potential in monotherapy and combination settings, both in
patients showing resistance to approved CDK 4/6 inhibitors and in indications where these agents are not currently approved. Narazaciclib's
clinical development plan is designed to test this hypothesis, and we look forward to its continued progress."
continued, "Beyond our lead program in narazaciclib, we also reported compelling preliminary clinical data from an investigator-sponsored
study of rigosertib in RDEB-associated SCC. These data showed a sustained complete response in a patient that was unresponsive to several
prior treatments. Though from a single patient, we believe these data represent a potentially powerful observation in this ultra-rare
indication given its invariably fatal nature and the lack of effective therapies. Rigosertib's additional investigator-sponsored
trials have also shown strong progress, as we are on track to report updated data from the Phase 1/2a study evaluating rigosertib-nivolumab
combination therapy in KRAS+ NSCLC this year, and to open a Phase 2 metastatic melanoma trial of oral rigosertib plus pembrolizumab in
the first half. Looking ahead, we will continue to leverage the collaborations that form the basis of these trials to pursue rigosertib's
clinical development across multiple indications while remaining primarily focused on our lead narazaciclib program."
Cash and cash equivalents
as of December 31, 2021, were $55.1 million, compared with $19.0 million as of December 31, 2020. The Company believes that
its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for at least two years.
Research and development
expenses were $7.3 million for 2021, compared with $16.9 million for 2020. The decrease was primarily related to the Company's
focus on its Phase 1 program with narazaciclib, following the completion of the Phase 3 INSPIRE study in 2020.
General and administrative
expenses were $9.4 million for 2021, compared with $8.3 million for 2020. The increase was primarily related to costs related to special
and annual general meeting expenses in the 2021 period.
was $16.2 million, or $0.96 per share on 16.8 million weighted average shares outstanding, compared with a net loss of $25.2 million,
or $2.17 per share for 2020 on 11.6 million weighted average shares outstanding.
an investment community conference call today beginning at 4:30 p.m. Eastern Time, during which management will discuss financial
results for 2021, provide a business update, and answer questions. Interested parties can participate by dialing (855) 428-5741 (domestic
callers) or (210) 229-8823 (international callers) and using conference ID 8097917.
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.
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.
novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase
1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.
product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion
Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung
For more information, please visit www.onconova.com.
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 the timing of Onconova's and investigator-initiated clinical
development and data presentation plans, and the mechanisms and indications for Onconova's product candidates. 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.
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated
| December 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | (unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 55,070 | $ | 19,025 | ||||
| Receivables | 28 | 37 | ||||||
| Prepaid expenses and other current assets | 332 | 722 | ||||||
| Total current assets | 55,430 | 19,784 | ||||||
| Property and equipment, net | 38 | 52 | ||||||
| Other non-current assets | 10 | 150 | ||||||
| Total assets | $ | 55,478 | $ | 19,986 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,757 | $ | 4,833 | ||||
| Accrued expenses and other current liabilities | 3,132 | 4,962 | ||||||
| Deferred revenue | 226 | 226 | ||||||
| Total current liabilities | 6,115 | 10,021 | ||||||
| Warrant liability | - | 321 | ||||||
| Deferred revenue, non-current | 3,243 | 3,469 | ||||||
| Total liabilities | 9,358 | 13,811 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock | - | - | ||||||
| Common stock | 209 | 124 | ||||||
| Additional paid in capital | 490,644 | 434,593 | ||||||
| Accumulated other comprehensive (loss) income | (14 | ) | 14 | |||||
| Accumulated deficit | (444,719 | ) | (428,556 | ) | ||||
| Total stockholders' equity | 46,120 | 6,175 | ||||||
| Total liabilities and stockholders' equity | $ | 55,478 | $ | 19,986 |
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated
Statements of Operations
except share and per share amounts)
| Year Ended December 31, | ||||||||
| 2021 | 2020 | |||||||
| (unaudited) | ||||||||
| Revenue | $ | 226 | $ | 231 | ||||
| Operating expenses: | ||||||||
| General and administrative | 9,425 | 8,326 | ||||||
| Research and development | 7,297 | 16,898 | ||||||
| Total operating expenses | 16,722 | 25,224 | ||||||
| Loss from operations | (16,496 | ) | (24,993 | ) | ||||
| Change in fair value of warrant liability | 321 | (208 | ) | |||||
| Other income, net | 12 | 48 | ||||||
| Net loss before income taxes | (16,163 | ) | (25,153 | ) | ||||
| Income tax expense | - | 4 | ||||||
| Net loss | (16,163 | ) | (25,157 | ) | ||||
| Net loss per share of common stock, basic and diluted | $ | (0.96 | ) | $ | (2.17 | ) | ||
| Basic and diluted weighted average shares outstanding | 16,832,198 | 11,602,391 |