Onconova Therapeutics, Inc. (NASDAQ: ONTX), a biopharmaceutical
company focused on discovering and developing novel products to
treat cancer, today reported financial results for the quarter
ended September 30, 2020 and provided a business update.
Management commentary
“During the third quarter, our product pipeline
advanced while we pursued various licensing opportunities. We are
particularly pleased that ON 123300, our proprietary,
differentiated, first-in-class multi-kinase inhibitor, entered the
clinic with HanX Biopharmaceuticals, our partner in China,” said
Steven M. Fruchtman, M.D., President and Chief Executive Officer of
Onconova. “The HanX Phase 1 dose-escalation study has enrolled
three patients to date, and is expected to continue to enroll
patients with advanced relapsed/refractory cancer at two sites
until the recommended Phase 2 dose is identified.
“In parallel, we are preparing to file an
Investigational New Drug application (IND) with the U.S. Food and
Drug Administration by the end of this year, with patient
enrollment expected to begin in the first quarter of 2021. We
expect that our Phase 1 dose-escalation and dose-expansion study in
the U.S. will differ from the HanX study in dose regimens and
treatment cycles, and believe that data from these two studies will
generate important information to inform anticipated later-stage
studies. Our plan is to enroll patients with a variety of advanced
solid tumors including an initial focus on HR+ HER2- postmenopausal
metastatic breast cancer patients with resistance to approved
second-generation CDK 4/6 inhibitors, as well as patients diagnosed
with advanced non-Hodgkin’s lymphoma based on efficacy data from
our preclinical models. We believe that, with its novel mechanism
of action targeting both CDK4/6 and ARK5, ON 123300 presents an
innovative approach for potentially treating HR+ HER2- metastatic
breast cancer that is or has become resistant to the commercial
CDK4/6 inhibitors, and potentially other cancers including mantle
cell lymphoma, multiple myeloma, advanced colorectal cancer,
advanced hepatocellular carcinoma, and inoperable
glioblastoma.”
“Important investigator-initiated studies are
also underway or planned with oral rigosertib,” added Richard
Woodman, M.D, Chief Medical Officer. “We are currently supporting a
Phase 1 dose-escalation study at a leading medical center in New
York City exploring the use of rigosertib in combination with the
PD-1 inhibitor nivolumabin progressive K-RAS mutated non-small cell
lung cancer (NSCLC). That study has enrolled five patients to date,
and is designed to identify the recommended Phase 2 dose of the
combination for future studies. Results are expected in 2021. In
addition, an investigator-initiated phase 1b/2 study with
rigosertib monotherapy in advanced squamous cell carcinoma
associated with recessive dystrophic epidermolysis bullosa has
opened, with first-patient-in expected 2021. Additional
investigator-initiated preclinical studies with rigosertib are
under consideration.”
“Our focus is on advancing our pipeline, and
while we believe ON 123300 and oral rigosertib have excellent
prospects, we are also engaged in licensing discussions, both for
geographic rights to certain of our assets, and evaluating the
potential to in-license additional compounds to expand our product
portfolio,” Dr. Fruchtman concluded.
Third
quarter
financial
results
Cash and cash equivalents as of September 30,
2020 were $24.2 million, compared with $22.7 million as of December
31, 2019. The Company expects that its cash and cash equivalents
will be sufficient to fund ongoing clinical trials and business
operations into the first quarter of 2022. During the third quarter
of 2020, the Company received $2.7 million from the exercise of
warrants.
Research and development expenses were $4.2
million for the third quarter of 2020, compared with $3.5 million
for the third quarter of 2019. The increase was primarily related
to higher 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.
General and administrative expenses were $2.1
million for the third quarter of 2020, compared with $1.6 million
for the third quarter of 2019. The increase was due to higher
pre-commercialization, insurance, and corporate legal and
stockholder meeting expenses.
Net loss for the third quarter of 2020 was $6.2
million, compared with $4.6 million for the comparable prior-year
quarter.
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 2020 third
quarter, 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 8687160.
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 biopharmaceutical
company focused on discovering and developing novel products to
treat 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 currently in a dose-escalation and expansion
Phase 1 trial in China, and the IND filing in the U.S. is
anticipated in the fourth quarter of 2020. 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.
Preclinical work with rigosertib in COVID-19 is ongoing as well. We
do not anticipate conducting clinical trials with rigosertib in
COVID-19 without securing additional funding. For more information,
please visit https://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 expectations regarding its
clinical development plans and patents. 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 approval of protocols, Onconova’s ability to
continue as a going concern, the need for additional financing, our
collaborations, 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.
Contact
information
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
|
|
|
|
ONCONOVA
THERAPEUTICS, INC. |
Condensed
Consolidated Balance Sheets |
(in thousands) |
|
September
30, |
|
December
31, |
|
2020 |
|
2019 |
Assets |
(unaudited) |
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
24,198 |
|
|
$ |
22,726 |
|
Receivables |
|
46 |
|
|
|
98 |
|
Prepaid expenses and other current assets |
|
757 |
|
|
|
650 |
|
Total current assets |
|
25,001 |
|
|
|
23,474 |
|
Property and
equipment, net |
|
56 |
|
|
|
50 |
|
Other
non-current assets |
|
150 |
|
|
|
150 |
|
Total
assets |
$ |
25,207 |
|
|
$ |
23,674 |
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
5,725 |
|
|
$ |
4,271 |
|
Accrued expenses and other current liabilities |
|
3,339 |
|
|
|
3,795 |
|
Deferred revenue |
|
226 |
|
|
|
226 |
|
Total current liabilities |
|
9,290 |
|
|
|
8,292 |
|
Warrant
liability |
|
176 |
|
|
|
113 |
|
Deferred
revenue, non-current |
|
3,526 |
|
|
|
3,695 |
|
Total
liabilities |
|
12,992 |
|
|
|
12,100 |
|
|
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock |
|
- |
|
|
|
- |
|
Common stock |
|
1,845 |
|
|
|
1,112 |
|
Additional paid in capital |
|
432,499 |
|
|
|
413,879 |
|
Accumulated other comprehensive loss |
|
(2 |
) |
|
|
(18 |
) |
Accumulated deficit |
|
(422,127 |
) |
|
|
(403,399 |
) |
Total
stockholders' equity |
|
12,215 |
|
|
|
11,574 |
|
Total
liabilities and stockholders' equity |
$ |
25,207 |
|
|
$ |
23,674 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
Revenue |
$ |
66 |
|
|
$ |
63 |
|
|
$ |
174 |
|
|
$ |
2,153 |
|
Operating
expenses: |
|
|
|
|
|
|
|
General and administrative |
|
2,147 |
|
|
|
1,640 |
|
|
|
6,548 |
|
|
|
6,634 |
|
Research and development |
|
4,193 |
|
|
|
3,521 |
|
|
|
12,364 |
|
|
|
11,490 |
|
Total operating expenses |
|
6,340 |
|
|
|
5,161 |
|
|
|
18,912 |
|
|
|
18,124 |
|
Loss from
operations |
|
(6,274 |
) |
|
|
(5,098 |
) |
|
|
(18,738 |
) |
|
|
(15,971 |
) |
|
|
|
|
|
|
|
|
Change in
fair value of warrant liability |
|
56 |
|
|
|
476 |
|
|
|
(63 |
) |
|
|
80 |
|
Other (loss)
income, net |
|
(23 |
) |
|
|
27 |
|
|
|
73 |
|
|
|
135 |
|
Net
loss |
|
(6,241 |
) |
|
|
(4,595 |
) |
|
|
(18,728 |
) |
|
|
(15,756 |
) |
Net loss per
share of common stock, basic and diluted |
$ |
(0.03 |
) |
|
$ |
(0.75 |
) |
|
$ |
(0.11 |
) |
|
$ |
(2.63 |
) |
Basic and
diluted weighted average shares outstanding |
|
180,877,623 |
|
|
|
6,141,933 |
|
|
|
170,297,531 |
|
|
|
5,994,423 |
|
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