Full Press Release Details
Onconova Therapeutics Reports Full Year
2020 Financial Results, Provides Business Update
Conference call begins at 4:30 p.m. Eastern
NEWTOWN, Pa., March 11, 2021 (GLOBE
NEWSWIRE) - Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical
company focused on discovering and developing novel therapies for patients with cancer, announces financial results for the twelve
months ended December 31, 2020 and provides a business update.
Highlights of the fourth quarter of 2020
and recent weeks include:
Management Commentary
"The fourth quarter and recent weeks
have been active and productive at Onconova as we continue to advance our lead product ON 123300 into the clinic," said Steven
M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "We submitted an Investigational New Drug application
to the FDA for a Phase 1 study in advanced cancers including HR+/HER 2- metastatic breast cancer patients resistant to approved
second-generation CDK 4/6 inhibitors. In December 2020, we received clearance from the FDA to begin the study, and have since
received IRB approval at our first site. We expect the first patient to be enrolled in the second quarter of this year. Two further
sites are in the study set-up process.
"This Phase 1 study will assess the
safety, tolerability and pharmacokinetics of ON 123300 administered orally at increasing doses starting at 40 mg daily continuously.
"Our partner in China, HanX Pharmaceuticals,
continues enrolling a similar patient population in a Phase 1 dose-escalation study with ON 123300 at two sites. The initial dose
cohort has been completed and the second dose cohort is enrolling. We are pleased that ON 123300 appears to be well tolerated so
far as no dose-limiting toxicities have been seen to date. The HanX study is dosing patients on a 21-day cycle. Collectively, the
U.S. and China Phase 1 studies are expected to provide data regarding the safety profile of ON 123300 and potentially provide preliminary
efficacy signals in patients with advanced cancer."
Commenting on ongoing investigator-sponsored
studies with oral rigosertib, the company's RAS pathway inhibitor, Dr. Fruchtman added, "We are currently supporting
investigator-initiated studies that are exploring the use of oral rigosertib for cancers driven by mutation of the RAS gene including
a Phase 1 study in combination with a PD-1 inhibitor for patients with progressive K-RAS mutated non-small cell lung cancer.
This study is open and continues to enroll patients, with the objectives to identify the recommended Phase 2 dose and to characterize
the safety profile of the combination treatment. Results are expected in 2021.
"In addition, an investigator-initiated
Phase 1b/2 study with oral rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis
bullosa is open. A preclinical study is also evaluating oral rigosertib in clear cell renal carcinoma. We anticipate
additional investigator-initiated studies in RAS-driven cancers in combination with PD-1 inhibitors, including in metastatic melanoma.
Other than the cost of supplying oral rigosertib to the investigators, Onconova does not expect to incur significant expense for
these studies," Dr. Fruchtman stated.
Full Year Financial Results
Cash and cash equivalents as of December 31,
2020 were $19.0 million, compared with $22.7 million as of December 31, 2019. Subsequent to the end of the quarter, the Company
raised net proceeds of $35.2 million from two equity offerings with institutional investors. The Company expects that its cash
and cash equivalents as of February 28, 2021 will be sufficient to fund ongoing clinical trials and business operations for
more than eighteen months.
Research and development expenses were
$16.9 million for 2020, compared with $15.5 million for 2019. The increase was primarily related to higher regulatory consulting
fees and manufacturing costs related to clinical supply for ON 123300, partially offset by lower expenses for the oral rigosertib
combination program and the Phase 3 INSPIRE study in the 2020 period.
General and administrative expenses were
$8.3 million for 2020, consistent with 2019. Lower personnel and stock compensation expenses in 2020 due to personnel reductions
in the 2019 period were offset by higher pre-commercialization, insurance, and corporate legal and stockholder meeting expenses
Net loss for 2020 was $25.2 million, or
$0.14 per share on 174.0 million weighted average shares outstanding, compared with a loss of $21.5 million, or $1.49 per share
for 2019 on 14.4 million weighted average shares outstanding.
Conference Call and Webcast
Onconova will host an investment community
conference call today beginning at 4:30 p.m. Eastern time, during which management will discuss financial results for 2020,
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 3863774.
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 therapies 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 ON 123300 is planned to begin a dose-escalation and expansion Phase 1 trial in the U.S. in 2Q21, and a dose-escalation
and expansion Phase 1 trial is currently underway in China. Onconova's product candidate oral rigosertib is currently in
a dose-escalation and expansion Phase 1 investigator-initiated study targeting patients with KRAS+ lung adenocarcinoma in combination
with nivolumab. In addition, Onconova continues to conduct preclinical work investigating rigosertib in COVID-19. 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 the registered direct offering, its patents
and clinical development plans including patient enrollment timelines and indications for its product candidates. Onconova has
attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates,"
"expects," "plans," "intends," "may," "could," "might," "will,"
"should," "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 and regulatory agency and institutional review board approvals of protocols, Onconova's ability
to continue as a going concern, the need for additional financing, 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.
LHA Investor Relations
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
| December 31, | December 31, | |||||||
| 2020 | 2019 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 19,025 | $ | 22,726 | ||||
| Receivables | 37 | 98 | ||||||
| Prepaid expenses and other current assets | 722 | 650 | ||||||
| Total current assets | 19,784 | 23,474 | ||||||
| Property and equipment, net | 52 | 50 | ||||||
| Other non-current assets | 150 | 150 | ||||||
| Total assets | $ | 19,986 | $ | 23,674 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,833 | $ | 4,271 | ||||
| Accrued expenses and other current liabilities | 4,962 | 3,795 | ||||||
| Deferred revenue | 226 | 226 | ||||||
| Total current liabilities | 10,021 | 8,292 | ||||||
| Warrant liability | 321 | 113 | ||||||
| Deferred revenue, non-current | 3,469 | 3,695 | ||||||
| Total liabilities | 13,811 | 12,100 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock | - | - | ||||||
| Common stock | 1,859 | 1,112 | ||||||
| Additional paid in capital | 432,858 | 413,879 | ||||||
| Accumulated other comprehensive income (loss) | 14 | (18 | ) | |||||
| Accumulated deficit | (428,556 | ) | (403,399 | ) | ||||
| Total stockholders' equity | 6,175 | 11,574 | ||||||
| Total liabilities and stockholders' equity | $ | 19,986 | $ | 23,674 |
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Statements of
Operations (unaudited)
(in thousands, except share and per share
| Year Ended December 31, | ||||||||
| 2020 | 2019 | |||||||
| (unaudited) | ||||||||
| Revenue | $ | 231 | $ | 2,183 | ||||
| Operating expenses: | ||||||||
| General and administrative | 8,326 | 8,345 | ||||||
| Research and development | 16,898 | 15,537 | ||||||
| Total operating expenses | 25,224 | 23,882 | ||||||
| Loss from operations | (24,993 | ) | (21,699 | ) | ||||
| Change in fair value of warrant liability | (208 | ) | 63 | |||||
| Other income, net | 48 | 143 | ||||||
| Net loss before income taxes | (25,153 | ) | (21,493 | ) | ||||
| Income tax expense | 4 | 10 | ||||||
| Net loss | (25,157 | ) | (21,503 | ) | ||||
| Net loss per share of common stock, basic and diluted | $ | (0.14 | ) | $ | (1.49 | ) | ||
| Basic and diluted weighted average shares outstanding | 174,035,872 | 14,384,476 |