Full Press Release Details
Onconova Therapeutics
Reports Second Quarter 2022 Financial Results and Provides Business Update
Conference call and live webcast at 4:30 p.m.
NEWTOWN, PA., August 11, 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 three months ended June 30, 2022, and
provided a business update.
Highlights for the second quarter of 2022 and
recent weeks include:
Management Commentary
"We saw sustained progress across our pipeline
over the past months and are well positioned to complete our current Phase 1 trials as we move through the second half of the year,"
said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "Narazaciclib continues to show a favorable safety
profile in its Phase 1 studies, which will be key to informing the design of future trials seeking to address the unmet needs posed by
the limitations of currently available CDK4/6 inhibitors. These limitations stem from issues related to safety, tolerability, and primary
and acquired drug resistance, which we believe narazaciclib's differentiated inhibitory profile may overcome. We were pleased to
publish preclinical data supporting this hypothesis at the most recent ASCO meeting and look forward to continued efforts to translate
these promising findings to the clinic."
Dr. Fruchtman continued, "Alongside narazaciclib's
advancement, we also made key progress in rigosertib's investigator-sponsored studies. This includes a Phase 2 trial evaluating
rigosertib combined with a PD-1 checkpoint inhibitor in checkpoint inhibitor refractory metastatic melanoma which is on schedule to open
for enrollment in the second half of 2022. This study seeks to leverage rigosertib's immunomodulatory effects and is supported by
initial data from the ongoing trial of rigosertib plus anti-PD-1 therapy in KRAS-mutated NSCLC. These data provided strong evidence of
the studied doublet's activity in patients who previously failed checkpoint inhibitor therapy, which is a finding we aim to build
upon with the presentation of additional data at a medical meeting later this quarter. Data has been presented, which will be updated,
demonstrating that responses seen with rigosertib in this setting are agnostic to the type of KRAS mutation present. This upcoming milestone
highlights how rigosertib's investigator-sponsored studies enable the capital efficient pursuit of value creating opportunities
to complement our lead narazaciclib program."
Second Quarter Financial Results
Cash and cash equivalents as of June 30, 2022,
were $46.5 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 for at least eighteen months.
Research and development expenses were $2.0 million
for the second quarter of 2022, compared with $1.9 million for the second quarter of 2021.
General and administrative expenses were $2.1
million for the second quarter of 2022, compared with $2.9 million for the second quarter of 2021.
Net loss for the second quarter of 2022 was $4.0
million, or $0.19 per share on 20.9 million weighted shares outstanding, compared with a net loss of $4.2 million, or $0.27 per share
for the second quarter of 2021 on 15.8 million weighted 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 second quarter
of 2022, provide a business update, and answer questions. Interested parties can participate by dialing (800) 289-0571 (domestic callers)
or (856) 344-9290 (international callers) and using conference ID 3600715.
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-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 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
| June 30 | December 31, | |||||||
| 2022 | 2021 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 46,533 | $ | 55,070 | ||||
| Receivables | 28 | 28 | ||||||
| Prepaid expenses and other current assets | 1,472 | 332 | ||||||
| Total current assets | 48,033 | 55,430 | ||||||
| Property and equipment, net | 31 | 38 | ||||||
| Other non-current assets | 10 | 10 | ||||||
| Total assets | $ | 48,074 | $ | 55,478 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,003 | $ | 2,757 | ||||
| Accrued expenses and other current liabilities | 3,231 | 3,132 | ||||||
| Deferred revenue | 226 | 226 | ||||||
| Total current liabilities | 6,460 | 6,115 | ||||||
| Deferred revenue, non-current | 3,130 | 3,243 | ||||||
| Total liabilities | 9,590 | 9,358 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock | - | - | ||||||
| Common stock | 209 | 209 | ||||||
| Additional paid in capital | 491,181 | 490,644 | ||||||
| Accumulated other comprehensive loss | (41 | ) | (14 | ) | ||||
| Accumulated deficit | (452,865 | ) | (444,719 | ) | ||||
| Total stockholders' equity | 38,484 | 46,120 | ||||||
| Total liabilities and stockholders' equity | $ | 48,074 | $ | 55,478 |
Consolidated Statements of Operations (unaudited)
(in thousands, except share and per share amounts)
| Three Months Ended June 30, | Six months months ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue | $ | 57 | $ | 57 | $ | 113 | $ | 113 | ||||||||
| Operating expenses: | ||||||||||||||||
| General and administrative | 2,139 | 2,850 | 4,325 | 5,067 | ||||||||||||
| Research and development | 2,038 | 1,852 | 4,040 | 3,789 | ||||||||||||
| Total operating expenses | 4,177 | 4,702 | 8,365 | 8,856 | ||||||||||||
| Loss from operations | (4,120 | ) | (4,645 | ) | (8,252 | ) | (8,743 | ) | ||||||||
| Change in fair value of warrant liability | - | 427 | - | (209 | ) | |||||||||||
| Other income (loss,) net | 96 | (13 | ) | 106 | 6 | |||||||||||
| Net loss | (4,024 | ) | (4,231 | ) | (8,146 | ) | (8,946 | ) | ||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.19 | ) | $ | (0.27 | ) | $ | (0.39 | ) | $ | (0.59 | ) | ||||
| Basic and diluted weighted average shares outstanding | 20,904,085 | 15,780,863 | 20,904,085 | 15,201,719 |