Full Press Release Details
Onconova Therapeutics Reports Full Year 2022
Financial Results and Provides Business Update
Conference call and live webcast at 4:30 p.m. ET
March 16, 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 twelve months ended December 31, 2022, and provided a business update.
Highlights for the fourth quarter of 2022 and
recent weeks include:
Management Commentary
"We recently received IRB approval at New
York University Langone Health for our Phase 1/2a trial of narazaciclib plus letrozole in recurrent LGEEC, which is on track for an important
preliminary readout later this year," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "Prior
preclinical data as well as single arm and randomized Phase 2 clinical data provide strong proof-of-concept for narazaciclib's mechanism
of action in LGEEC and demonstrate its potential to overcome the numerous shortcomings of the CDK 4/6 inhibitors that are currently used
off-label in combination with letrozole in this indication. We look forward to building on these datasets in our upcoming trial, which
we believe will further highlight the advantages of narazaciclib's differentiated kinase inhibitory profile."
Dr. Fruchtman continued, "Recent progress
in rigosertib's investigator-sponsored trials was highlighted by data from our RDEB-associated SCC program. With both of the program's
evaluable participants achieving a complete clinical response of all cancerous skin lesions with rigosertib monotherapy, we now intend
to engage with regulators to identify the most expeditious path to a potential approval in this ultra-orphan indication. In addition,
trials of rigosertib combined with checkpoint inhibition continue to advance, with a Phase 2 study in checkpoint-inhibitor refractory
melanoma expected to open for enrollment later this quarter and additional data from a Phase 1/2a trial in KRAS-mutated NSCLC expected
next quarter. Looking forward, we expect the continued progress of these investigator-sponsored trials to provide an important source
of value to complement our lead narazaciclib program, which remains our primary focus."
Full Year Financial Results
Cash and cash equivalents as of December 31,
2022, were $38.8 million, compared with $55.1 million as of December 31, 2021. 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 $11.4 million
for 2022, compared with $7.3 million for 2021. The increase was primarily related to the narazaciclib development program and drug manufacturing.
General and administrative expenses were $8.4
million for 2022, compared with $9.4 million for 2021. The decrease was primarily related to lower costs for our annual general meeting
than in the 2021 period.
Net loss for 2022 was $19.0 million, or $0.91
per share on 20.9 million weighted average shares outstanding, compared with a net loss of $16.2 million, or $0.96 per share for 2021
based on 16.8 million weighted average 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 full year 2022, 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 3097517.
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 two separate and complementary Phase 1 dose escalation and expansion
studies. These trials are currently underway in the United States and China. Based on preclinical and clinical studies of CDK 4/6 inhibitors,
Onconova is also planning a combination trial of narazaciclib with estrogen blockade in advanced endometrial cancer, as well as its clinical
study 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, and a Phase 2 program evaluating rigosertib monotherapy
in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC).
For more information,
please visit www.onconova.com.
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.
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
| December 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 38,757 | $ | 55,070 | ||||
| Receivables | 29 | 28 | ||||||
| Prepaid expenses and other current assets | 561 | 332 | ||||||
| Total current assets | 39,347 | 55,430 | ||||||
| Property and equipment, net | 24 | 38 | ||||||
| Other non-current assets | 1 | 10 | ||||||
| Total assets | $ | 39,372 | $ | 55,478 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,860 | $ | 2,757 | ||||
| Accrued expenses and other current liabilities | 3,960 | 3,132 | ||||||
| Deferred revenue | 226 | 226 | ||||||
| Total current liabilities | 8,046 | 6,115 | ||||||
| Deferred revenue, non-current | 3,017 | 3,243 | ||||||
| Total liabilities | 11,063 | 9,358 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock | - | - | ||||||
| Common stock | 209 | 209 | ||||||
| Additional paid in capital | 491,816 | 490,644 | ||||||
| Accumulated other comprehensive loss | (33 | ) | (14 | ) | ||||
| Accumulated deficit | (463,683 | ) | (444,719 | ) | ||||
| Total stockholders' equity | 28,309 | 46,120 | ||||||
| Total liabilities and stockholders' equity | $ | 39,372 | $ | 55,478 |
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
| Year Ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| (unaudited) | ||||||||
| Revenue | $ | 226 | $ | 226 | ||||
| Operating expenses: | ||||||||
| General and administrative | 8,447 | 9,425 | ||||||
| Research and development | 11,406 | 7,297 | ||||||
| Total operating expenses | 19,853 | 16,722 | ||||||
| Loss from operations | (19,627 | ) | (16,496 | ) | ||||
| Change in fair value of warrant liability | - | 321 | ||||||
| Other income, net | 663 | 12 | ||||||
| Net loss | (18,964 | ) | (16,163 | ) | ||||
| Net loss per share of common stock, basic and diluted | $ | (0.91 | ) | $ | (0.96 | ) | ||
| Basic and diluted weighted average shares outstanding | 20,908,235 | 16,832,198 |