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Onconova Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update Conference call and live webcast at 4:30 p.m. ET today NEWTOWN, PA.

Key Takeaway: Onconova Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update Conference call and live webcast at 4:30 p.m. NEWTOWN, PA., November 11, 2021 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova"), a clinical-stage biophar

Full Press Release Details

Onconova Therapeutics
Reports Third Quarter 2021 Financial Results and Provides Business Update
Conference call and live webcast at 4:30 p.m.
NEWTOWN, PA., November 11, 2021 (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 September
30, 2021, and provided a business update.
Highlights for the third quarter of 2021 and subsequent
Management Commentary
"Our progress during the third quarter has
us on track to achieve milestones across our pipeline," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of
Onconova. "In our lead narazaciclib program, the advancement of our complementary Phase 1 studies has us on track to identify a
recommended Phase 2 dose in the first half of 2022 and then initiate a Phase 2 safety and efficacy study in the second half. This Phase
2 study will focus on multiple oncology indications with high unmet need, including CDK 4/6 inhibitor refractory HR+ HER2- metastatic
breast cancer. Preclinical studies have shown that narazaciclib may be able overcome resistance to approved CDK 4/6 inhibitors, and therefore
may have an improved on-target toxicity profile. We believe this positions narazaciclib as a potentially important therapeutic in a multi-billion-dollar
drug class. We look forward to evaluating this hypothesis through narazaciclib's continued clinical development."
Dr. Fruchtman continued, "Outside our
narazaciclib program, we recently reported very encouraging data from the Phase 1/2a investigator-initiated study (IIS) of oral
rigosertib plus the PD-1 checkpoint inhibitor nivolumab in advanced KRAS+ NSCLC. These data showed partial responses across multiple
KRAS variants in patients who previously failed the standard of care including PD-1 checkpoint inhibitors. This suggests rigosertib
may augment the efficacy of checkpoint inhibitors and could differentiate it from competing RAS pathway modulators that target a
particular KRAS mutation. Looking ahead, we expect to provide an additional data update from this study in 2022 and begin an
additional IIS evaluating rigosertib in combination with anti-PD-1 therapy in malignant melanoma in the first half of next year.
Through the progression of these and our other IIS in RDEB-associated SCC, we aim to generate value and address the needs of
patients through rigosertib's development, while maintaining our primary focus on our lead narazaciclib program."
Third Quarter Financial Results
Cash and cash equivalents as of September 30,
2021, were $59.4 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 more than two years.
Research and development expenses were $1.8 million
for the third quarter of 2021, compared with $4.2 million for the third quarter of 2020. The decrease was primarily related to higher
costs related to the INSPIRE study in the 2020 period.
General and administrative expenses were $2.3
million for the third quarter of 2021, compared with $2.1 million for the third quarter of 2020.
Net loss for the third quarter of 2021 was $3.5
million, or $0.22 per share on 16.0 million weighted average shares outstanding, compared with a net loss for the third quarter of 2020
of $6.2 million, or $0.52 per share on 12.1 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 the third quarter of 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 5367655.
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 two separate and complementary Phase 1 dose-escalation and expansion
studies. These trials are currently underway in the United States and China.
Onconova's product candidate rigosertib
is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1/2a investigator-initiated
study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.
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 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 Balance Sheets
September 30 December 31,
2021 2020
(unaudited)
Assets
Current assets:
Cash and cash equivalents $ 59,378 $ 19,025
Receivables 29 37
Prepaid expenses and other current assets 529 722
Total current assets 59,936 19,784
Property and equipment, net 42 52
Other non-current assets 12 150
Total assets $ 59,990 $ 19,986
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 4,050 $ 4,833
Accrued expenses and other current liabilities 2,749 4,962
Deferred revenue 226 226
Total current liabilities 7,025 10,021
Warrant liability - 321
Deferred revenue, non-current 3,299 3,469
Total liabilities 10,324 13,811
Stockholders' equity:
Preferred stock - -
Common stock 209 124
Additional paid in capital 490,418 434,593
Accumulated other comprehensive (loss) income (6 ) 14
Accumulated deficit (440,955 ) (428,556 )
Total stockholders' equity 49,666 6,175
Total liabilities and stockholders' equity $ 59,990 $ 19,986
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Statements
of Operations (unaudited)
(in thousands, except share and per share amounts)
Three Months Ended September 30, Nine months months ended September 30,
2021 2020 2021 2020
Revenue $ 57 $ 66 $ 170 $ 174
Operating expenses:
General and administrative 2,284 2,147 7,351 6,548
Research and development 1,763 4,193 5,552 12,364
Total operating expenses 4,047 6,340 12,903 18,912
Loss from operations (3,990 ) (6,274 ) (12,733 ) (18,738 )
Change in fair value of warrant liability 530 56 321 (63 )
Other income (loss,) net 7 (23 ) 13 73
Net loss (3,453 ) (6,241 ) (12,399 ) (18,728 )
Net loss per share of common stock, basic and diluted $ (0.22 ) $ (0.52 ) $ (0.80 ) $ (1.65 )
Basic and diluted weighted average shares outstanding 15,979,180 12,058,508 15,463,720 11,353,169
Last updated: Nov 11, 2021