Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage
biopharmaceutical company focused on discovering and developing
novel products to treat cancer, with an initial focus on
myelodysplastic syndromes (MDS), today reported financial results
for the year ended December 31, 2019 and provided a corporate
update.
“Following significant progress throughout 2019,
our team’s immediate focus remains to advance our pivotal Phase 3
INSPIRE trial to the next milestone,” said Steven M. Fruchtman,
M.D., President and Chief Executive Officer. “We are excited to
announce the completion of the planned enrollment of 360 patients
in the INSPIRE trial in higher-risk (HR) MDS patients. INSPIRE
represents one of the largest studies ever conducted in this
patient population. Based on survival trends on the INSPIRE trial
to date, we anticipate reporting topline survival data in the
second half of 2020 and presenting the results at a medical meeting
later this year. We continue to analyze deep genomic sequencing,
including mutations of the Ras pathway, on these patients.
Important genomic results were presented at ASH 2019 and additional
data is expected to be presented at future medical meetings.”
Dr. Selina Luger, M.D., Professor of Medicine at
the Hospital of the University of Pennsylvania Division of
Hematology Oncology, commented, “in second line HR MDS, following
progression or failure of patients to respond to hypomethylating
agents, there is no standard of care and currently no health
authority approved agent in the world. There is a tremendous unmet
medical need for these patients. The INSPIRE trial, which has now
reached full accrual, is studying the experimental agent rigosertib
to determine if it can significantly prolong the survival of these
patients when compared to physician’s choice of therapy. We eagerly
look forward to the results of this pivotal trial.”
Dr. Fruchtman continued, “We are also pleased
about the progress of our plans for additional
investigator-initiated studies – including the Phase 1/2a study of
rigosertib plus nivolumab for the treatment of Stage IV KRAS
mutated lung adenocarcinoma. We anticipate the first patient
to be entered onto the trial once the COVID-19 environment improves
sufficiently.”
Fourth Quarter 2019 and Additional
Achievements
- Knight Therapeutics License for Rigosertib in Canada
- Specialised Therapeutics License for Rigosertib in Australia
and New Zealand
- Inceptua Medicines Pre-approval Access Collaboration for
Rigosertib in Selected Countries Outside the US
- Re-acquired Rigosertib Rights in Greater China
- Next generation CDK 4/6 + ARK5 inhibitor, ON123300, IND
approved in China
Additional Milestones for Rigosertib and Pipeline
Products
- Clinical trial protocol progressing for a randomized Phase 2/3
study of the combination of oral rigosertib plus azacitidine
- Expansion of the rigosertib investigator-initiated studies
program to include KRAS mutated non-small cell lung cancer,
melanoma and other RAS mutated-driven cancers
- Next generation CDK 4/6 + ARK5 inhibitor, ON123300, US IND
submission planned in 4Q 2020
- Pivotal survival data from the INSPIRE trial expected in 2H
2020
Full Year 2019 Financial Results
Cash and cash equivalents as of December 31,
2019, totaled $22.7 million, compared to $17.0 million as of
December 31, 2018. Besides the $9 million of net proceeds from the
financing closed in early 2020, common stock warrant exercises
since 12/31/19 have added $5.7 million to the Company’s cash
balance resulting in a cash balance at February 29, 2020 of $32.6
million. Based on current projections, the Company expects that
cash and cash equivalents will be sufficient to fund ongoing trials
and operations into the third quarter of 2021.
Net loss was $21.5 million for the year ended
December 31, 2019, compared to $20.4 million for the year ended
December 31, 2018. Research and development expenses were
$15.5 million for the year ended December 31, 2019 and $16.9
million for the comparable period in 2018. General and
administrative expenses were $8.3 million for the year ended
December 31, 2019 and $7.6 million for the comparable period in
2018.
Conference Call and Webcast
Information
The Company will host a conference call today,
March 24, 2020, at 4:30 p.m. Eastern Time, to provide a corporate
update and discuss year-end 2019 financial results. Interested
parties may access the call by dialing toll-free (855) 428-5741
from the U.S., or internationally (210) 229-8823 and using
conference ID 3267259. The call will also be webcast live. Please
click here to access the webcast. A replay will be
available following the live webcast.
About Onconova Therapeutics,
Inc.
Onconova Therapeutics, Inc. is a Phase 3-stage
biopharmaceutical company focused on discovering and developing
novel drugs to treat cancer, with an initial focus on
myelodysplastic syndromes (MDS). Onconova has a pipeline of
proprietary targeted agents designed to work against specific
cellular pathways that are important in cancer cells.
Advanced clinical trials with the Company’s lead compound,
rigosertib, are aimed at what the Company believes are unmet
medical needs of patients with MDS. Onconova has conducted
trials with two other research compounds and has a pre-clinical
program with a CDK4/6 and Ark5 inhibitor, ON 123300.
For more information, please visit
http://www.onconova.com.
About Myelodysplastic
Syndromes
Myelodysplastic syndromes (MDS) are conditions
that can occur when the blood-forming cells in the bone marrow
become dysfunctional and thus produce an inadequate number of
circulating blood cells. It is frequently associated with the
presence of blasts or leukemic cells in the marrow. This
leads to low numbers of one or more types of circulating blood
cells, and to the need for blood transfusions. In MDS, some of the
cells in the bone marrow are abnormal (dysplastic) and may have
genetic abnormalities associated with them. Different cell
types can be affected, although the most common finding in MDS is a
shortage of red blood cells (anemia). Patients with
higher-risk MDS may progress to the development of acute
leukemia.
About Rigosertib
Rigosertib, Onconova’s lead candidate, is a
proprietary Phase 3 small molecule. A key publication in a
preclinical model reported rigosertib’s ability to block cellular
signaling by targeting RAS effector pathways (Divakar, S.K., et
al., 2016: "A Small Molecule RAS-Mimetic Disrupts RAS Association
with Effector Proteins to Block Signaling." Cell 165, 643).
Onconova is currently in the clinical development stage with oral
and IV rigosertib, including clinical trials studying single agent
IV rigosertib in second-line higher-risk MDS patients (pivotal
Phase 3 INSPIRE trial) and oral rigosertib plus azacitidine in HMA
naive and refractory higher-risk MDS patients (Phase 2).
Patents covering oral and injectable rigosertib have been issued in
the US and are expected to provide coverage until at least
2037.
About the INSPIRE Phase 3 Clinical
Trial
The clinical trial
INternational Study of
Phase 3 IV
RigosErtib, or
INSPIRE, was finalized following guidance received
from the U.S. Food and Drug Administration and European Medicines
Agency. INSPIRE is a global, multi-center, randomized,
controlled study to assess the efficacy and safety of IV rigosertib
in higher-risk MDS (HR-MDS) patients who had progressed on, failed
to respond to, or relapsed after previous treatment with a
hypomethylating agent (HMA) within nine cycles over the course of
one year after initiation of HMA treatment. This time frame
optimizes the opportunity to respond to treatment with an HMA prior
to declaring treatment failure, as per NCCN Guidelines.
Patients are randomized at a 2:1 ratio into two study arms: IV
rigosertib plus Best Supportive Care versus Physician's Choice plus
Best Supportive Care. The primary endpoint of INSPIRE is
overall survival. The trial continued beyond the
pre-specified interim analysis and is nearing its conclusion. Full
details of the INSPIRE trial, such as inclusion and exclusion
criteria, as well as secondary endpoints, can be found on
clinicaltrials.gov (NCT02562443).
About IV Rigosertib
The intravenous form of rigosertib has been
studied in Phase 1, 2, and 3 clinical trials involving more than
1000 patients, and is currently being evaluated in a randomized
Phase 3 international INSPIRE trial for patients with
HR-MDS after failure of HMA therapy.
About Oral Rigosertib
The oral form of rigosertib was developed to
provide a potentially more convenient dosage form for use where the
duration of treatment may extend to multiple years. This dosage
form may also support combination therapy modalities. To date,
over 400 patients have been dosed with the oral formulation of
rigosertib in clinical trials. Combination therapy of oral
rigosertib with azacitidine, the standard of care in HR-MDS, has
also been studied. Currently, oral rigosertib is being developed as
a combination therapy together with azacitidine for patients with
higher-risk MDS who require HMA therapy. A Phase 1/2 trial of the
combination therapy has been fully enrolled, and the updated
efficacy and safety data was presented at the ASH 2019 Annual
Meeting in December 2019.
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 the
INSPIRE Trial and Onconova’s other development plans. 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 Onconova's ability to continue as a going
concern, maintain its Nasdaq listing, the need for additional
financing, the success and timing of Onconova's clinical trials and
regulatory approval of protocols, our collaborations including the
effective termination of the HanX license and securities purchase
agreements and plans for partnering certain territories, 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.
Press release contact information
Company Contact:Avi Oler Onconova Therapeutics,
Inc.
267-759-3680 ir@onconova.ushttps://www.onconova.com/contact/
MediaDavid Schull, Russo Partners LLC: (212) 845-4271Nic
Johnson, Russo Partners LLC: (212) 845-4242
InvestorsJan Medina, CFA, Russo Partners LLC: (646) 942-5632
TABLES FOLLOW
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Balance
Sheets
(in thousands)
|
|
December 31, |
|
December 31, |
|
|
|
2019 |
|
|
|
2018 |
|
|
Assets |
(unaudited) |
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
22,726 |
|
|
$ |
16,970 |
|
|
Receivables |
|
98 |
|
|
|
35 |
|
|
Prepaid expenses and other current assets |
|
650 |
|
|
|
760 |
|
|
Total current assets |
|
23,474 |
|
|
|
17,765 |
|
|
Property and equipment,
net |
|
50 |
|
|
|
9 |
|
|
Other non-current assets |
|
150 |
|
|
|
149 |
|
|
Total assets |
$ |
23,674 |
|
|
$ |
17,923 |
|
|
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
$ |
4,271 |
|
|
$ |
4,039 |
|
|
Accrued expenses and other current liabilities |
|
3,795 |
|
|
|
4,173 |
|
|
Deferred revenue |
|
226 |
|
|
|
226 |
|
|
Total current liabilities |
|
8,292 |
|
|
|
8,438 |
|
|
Warrant liability |
|
113 |
|
|
|
176 |
|
|
Deferred revenue,
non-current |
|
3,695 |
|
|
|
3,922 |
|
|
Total liabilities |
|
12,100 |
|
|
|
12,536 |
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
Preferred stock |
|
- |
|
|
|
- |
|
|
Common stock |
|
1,112 |
|
|
|
57 |
|
|
Additional paid in capital |
|
413,879 |
|
|
|
387,238 |
|
|
Accumulated other comprehensive income |
|
(18 |
) |
|
|
(12 |
) |
|
Accumulated deficit |
|
(403,399 |
) |
|
|
(381,896 |
) |
|
Total Onconova Therapeutics
Inc. stockholders' equity |
|
11,574 |
|
|
|
5,387 |
|
|
Non-controlling interest |
|
- |
|
|
|
- |
|
|
Total stockholders'
equity |
|
11,574 |
|
|
|
5,387 |
|
|
Total liabilities and
stockholders' equity |
$ |
23,674 |
|
|
$ |
17,923 |
|
|
|
|
|
|
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Statements of
Operations (unaudited)
(in thousands, except share and per share
amounts)
|
Year Ended December 31, |
|
|
2019 |
|
|
|
2018 |
|
|
(unaudited) |
|
|
Revenue |
$ |
2,183 |
|
|
$ |
1,228 |
|
Operating expenses: |
|
|
|
General and administrative |
|
8,345 |
|
|
|
7,586 |
|
Research and development |
|
15,537 |
|
|
|
16,924 |
|
Total operating expenses |
|
23,882 |
|
|
|
24,510 |
|
Loss from operations |
|
(21,699 |
) |
|
|
(23,282 |
) |
|
|
|
|
Change in fair value of
warrant liability |
|
63 |
|
|
|
1,597 |
|
Other income, net |
|
143 |
|
|
|
1,151 |
|
Net loss before income
taxes |
|
(21,493 |
) |
|
|
(20,534 |
) |
Income tax (benefit)
expense |
|
10 |
|
|
|
(124 |
) |
Net loss |
|
(21,503 |
) |
|
|
(20,410 |
) |
Net gain attributable to
non-controlling interest |
|
- |
|
|
|
(163 |
) |
Net loss attributable to
Onconova Therapeutics, Inc |
$ |
(21,503 |
) |
|
$ |
(20,573 |
) |
|
|
|
|
Net loss per share of common
stock, basic and diluted |
$ |
(1.49 |
) |
|
$ |
(4.99 |
) |
Basic and diluted weighted
average shares outstanding |
|
14,384,476 |
|
|
|
4,124,073 |
|
|
|
|
|
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