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:
- ON 123300, Onconova’s proprietary
multi-kinase inhibitor, received clearance from the U.S. Food and
Drug Administration (FDA) to begin Phase 1 studies
- ON 123300 also received
Institutional Review Board (IRB) approval at one U.S. clinical
trial site
- The Phase 1 solid tumor study with
ON 123300 in China is ongoing and continues to enroll patients
- Raised net proceeds of $35.2
million from two equity offerings; cash and cash equivalents as of
February 28, 2021 were approximately $49.5 million
- An independent
investigator-initiated study with oral rigosertib in combination
with a PD-1 inhibitor in advanced KRAS mutated non-small cell lung
cancer is ongoing
- A Special Meeting of Stockholders
to consider changes to the capital structure of the Company will
reconvene on April 1, 2021
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 ResultsCash
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 in the 2020
period.
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
WebcastOnconova 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 StatementsSome
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.
Company Contact:Avi
OlerOnconova Therapeutics, Inc.267-759-3680
ir@onconova.ushttps://www.onconova.com/contact/
Investor Contact:LHA Investor
Relations Kim Sutton Golodetz212-838-3777kgolodetz@lhai.com
(Tables to follow)
|
ONCONOVA THERAPEUTICS, INC. |
Condensed Consolidated Balance Sheets |
(in thousands) |
|
|
December 31, |
|
|
December 31, |
|
|
2020 |
|
|
2019 |
|
Assets |
(unaudited) |
|
|
|
|
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 amounts) |
|
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 |
|
|
|
|
|
|
|
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