Full Press Release Details
Onconova Therapeutics Reports Second Quarter
Results and Provides Business Update
Conference call and live webcast at 4:30 p.m. ET
August 12, 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 June 30, 2021 and provided a business update.
Highlights for the second quarter of 2021 and
subsequent weeks include:
Management Commentary
"During the second quarter we achieved key
clinical and corporate milestones," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "In
our lead ON 123300 program, we initiated our U.S. Phase 1 study and recently opened enrollment to the second cohort, and our partner,
HanX Biopharmaceuticals, is currently enrolling to the third dose cohort of the complementary Phase 1 study underway in China. Through
these trials, which are evaluating different dosing administration regimens, we aim to inform the design of a future Phase 2 basket trial
evaluating ON 123300 in multiple high unmet need indications, including CDK 4/6 inhibitor refractory HR+ HER2- metastatic breast cancer.
Given ON 123300's ability in preclinical studies to overcome resistance to the most widely prescribed CDK 4/6 inhibitor, we believe
this novel multi-kinase inhibitor has the potential to be a best-in-class therapy for this and other cancers."
continued, "Beyond our lead program, we also reported very encouraging preliminary results from the investigator-initiated study
evaluating rigosertib plus nivolumab in advanced KRAS-mutated NSCLC. These results highlighted the doublet's favorable safety profile
and provided preliminary evidence of efficacy in an extremely challenging patient population. Additional preliminary data from the trial
is expected to be presented at a RAS-focused medical meeting in September. Looking forward, we will continue to leverage
investigator-initiated programs to further rigosertib's clinical development, while maintaining our primary focus and resources
on ON 123300. Milestones ahead for the remainder of the year include continued progress of our ON 123300 clinical trials, expansion of
rigosertib investigator-initiated studies program, and potentially acquiring new assets to augment our pipeline. With a strong financial
position and a talented management team that was recently bolstered by the appointment of Dr. Mark Gelder as CMO, we believe we
are well positioned to take advantage of the product development opportunities presented."
Second Quarter Financial Results
Cash and cash equivalents as of June 30,
2021 were $43.7 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 eighteen months.
Research and development expenses were $1.9 million
for the second quarter of 2021, compared with $4.8 million for the second quarter of 2020. The decrease was primarily related to higher
clinical trial and consulting expenses in the 2020 period due to the INSPIRE study.
General and administrative expenses were $2.9
million for the second quarter of 2021, compared with $2.6 million for the second quarter of 2020. The increase was primarily due to expenses
related to special meetings by proxy in the 2021 period.
Net loss for the second quarter of 2021 was $4.2
million, or $0.27 per share on 15.8 million weighted average shares outstanding, compared with a net loss for the second quarter of 2020
of $7.4 million, or $0.65 per share on 11.3 million weighted average shares outstanding.
Conference Call and Webcast
an investment community conference call today beginning at 4:30 p.m. Eastern Time, during which management will discuss financial
results for the second 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 3876025.
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 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 targeting patients with KRAS+ non-small cell lung cancer with oral rigosertib in combination with nivolumab.
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,"
"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, the timing of the
Company's annual stockholder meeting, 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
| June 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | (unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 43,709 | $ | 19,025 | ||||
| Receivables | 27 | 37 | ||||||
| Prepaid expenses and other current assets | 457 | 722 | ||||||
| Total current assets | 44,193 | 19,784 | ||||||
| Property and equipment, net | 45 | 52 | ||||||
| Other non-current assets | 140 | 150 | ||||||
| Total assets | $ | 44,378 | $ | 19,986 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,290 | $ | 4,833 | ||||
| Accrued expenses and other current liabilities | 2,983 | 4,962 | ||||||
| Deferred revenue | 226 | 226 | ||||||
| Total current liabilities | 7,499 | 10,021 | ||||||
| Warrant liability | 530 | 321 | ||||||
| Deferred revenue, non-current | 3,356 | 3,469 | ||||||
| Total liabilities | 11,385 | 13,811 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock | - | - | ||||||
| Common stock | 158 | 124 | ||||||
| Additional paid in capital | 470,335 | 434,593 | ||||||
| Accumulated other comprehensive income | 2 | 14 | ||||||
| Accumulated deficit | (437,502 | ) | (428,556 | ) | ||||
| Total stockholders' equity | 32,993 | 6,175 | ||||||
| Total liabilities and stockholders' equity | $ | 44,378 | $ | 19,986 |
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
| Three Months Ended June 30, | Six months months ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue | $ | 57 | $ | 56 | $ | 113 | $ | 108 | ||||||||
| Operating expenses: | ||||||||||||||||
| General and administrative | 2,850 | 2,594 | 5,067 | 4,401 | ||||||||||||
| Research and development | 1,852 | 4,801 | 3,789 | 8,171 | ||||||||||||
| Total operating expenses | 4,702 | 7,395 | 8,856 | 12,572 | ||||||||||||
| Loss from operations | (4,645 | ) | (7,339 | ) | (8,743 | ) | (12,464 | ) | ||||||||
| Change in fair value of warrant liability | 427 | (56 | ) | (209 | ) | (119 | ) | |||||||||
| Other (loss) income, net | (13 | ) | - | 6 | 96 | |||||||||||
| Net loss | (4,231 | ) | (7,395 | ) | (8,946 | ) | (12,487 | ) | ||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.27 | ) | $ | (0.65 | ) | $ | (0.59 | ) | $ | (1.14 | ) | ||||
| Basic and diluted weighted average shares outstanding | 15,780,863 | 11,303,508 | 15,201,719 | 10,996,624 |