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 quarter ended March 31, 2020, and provided a business
update.
“With enrollment completed in March, Onconova’s
pivotal Phase 3 INSPIRE trial is advancing to the next catalyst. We
are fortunate to have achieved full enrollment of INSPIRE prior to
the pandemic-driven disruptions to research studies at hospitals
and cancer centers across the globe,” said Steven M. Fruchtman,
M.D., President and Chief Executive Officer. “Based on survival
trends in the INSPIRE trial, we continue to anticipate reporting
topline survival data in the second half of 2020. We expect to
present the results of this trial at a major medical meeting later
this year.”
Dr. Fruchtman continued, “Beyond INSPIRE, we are
primed for additional progress, including the to be initiated Phase
1/2a study of rigosertib plus nivolumab in Stage IV KRAS mutated
lung adenocarcinoma, following the renewal of clinical cancer
research programs post their COVID-mandated stoppage, as well as
additional planned studies of rigosertib and our pipeline programs.
We are preparing for and look forward to multiple corporate
milestones in the second half of 2020.”
First Quarter 2020 Developments and
Recent Highlights
- Completed enrollment of the pivotal
Phase 3 INSPIRE trial
- Opened investigator-initiated study
of rigosertib plus nivolumab in Stage IV KRAS mutated lung
adenocarcinoma
- Re-acquired rights to rigosertib in
Greater China
- Next generation CDK 4/6 + ARK5
inhibitor, ON123300, IND approved in China
- Nominated life sciences industry
veteran Terri Shoemaker to the Company’s Board of Directors
Additional Upcoming Company Milestones
Expected
- Pivotal survival data from the
INSPIRE trial expected in 2H 2020
- European Hematology Association
Virtual Congress presentation in June 2020:
- Mutations in RAS Pathway Genes Correlates with Type of Failure
to Azacitidine: Genomic Analysis at Randomization onto the Inspire
Trial (EHA-4044)
- Type C meeting to be requested in
2Q 2020 for a randomized Phase 2/3 study of the combination of oral
rigosertib plus azacitidine
- Expansion of the rigosertib
investigator-initiated 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 for 4Q 2020, and
Phase 1 study commencement in China planned for 2H 2020
- Anticipated launch of Early Access
Program with Inceptua Medicines Group in 2H 2020
First Quarter 2020 Financial
ResultsCash and cash equivalents as of March 31, 2020,
totaled $31.0 million, compared to $22.7 million as of December 31,
2019. Common stock warrant exercises since our financing
transaction in November 2019 have added $10.6 million to our
balance sheet. Of the almost 29 million common stock warrants
outstanding as of March 31, 2020, over 80% of them were
in-the-money as of May 13th. Based on current projections, the
Company continues to expect that its cash and cash equivalents as
of March 31, 2020 will be sufficient to fund ongoing trials and
operations into the third quarter of 2021.
Net loss was $5.1 million for the quarter ended
March 31, 2020, compared to $7.6 million for the quarter ended
March 31, 2019. Research and development expenses were $3.4 million
for the quarter ended March 31, 2020 and $4.1 million for the
comparable period in 2019. General and administrative expenses were
$1.8 million for the quarter ended March 31, 2020 and $3.2 million
for the comparable period in 2019.
Conference Call and Webcast
InformationThe Company will host a conference call today,
May 14, 2020, at 4:30 p.m. Eastern Time, to provide a corporate
update and discuss first quarter 2020 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 3488818. The call will also be webcast live. Please
click here to access the webcast. A replay will be
available following the live webcast.
To facilitate an on-time conference call start,
Onconova recommends that participants dial in 15 minutes before the
4:30 p.m. ET start time.
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 https://www.onconova.com/.
About Myelodysplastic
SyndromesMyelodysplastic 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 RigosertibRigosertib,
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-naïve 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
TrialThe clinical
trial INternational Study
of Phase
3 IV RigosErtib
(INSPIRE) was finalized following guidance
received from the U.S. Food and Drug Administration and the
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 RigosertibThe
intravenous form of rigosertib has been studied in Phase 1, 2, and
3 clinical trials involving more than 1,200 patients, and is
currently being evaluated in a randomized Phase 3 international
trial (INSPIRE) 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 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 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
OlerOnconova Therapeutics, Inc.267-759-3680ir@onconova.us
Media David Schull, Russo Partners
LLC: (212) 845-4271Nic Johnson, Russo Partners LLC: (212)
845-4242
Investors Jan Medina, CFA, Russo Partners LLC:
(646) 942-5632
TABLES FOLLOW
ONCONOVA THERAPEUTICS,
INC.Condensed Consolidated Balance
Sheets(in thousands)
|
March 31, |
|
December 31, |
|
|
2020 |
|
|
|
2019 |
|
Assets |
(unaudited) |
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
31,036 |
|
|
$ |
22,726 |
|
Receivables |
|
45 |
|
|
|
98 |
|
Prepaid expenses and other current assets |
|
795 |
|
|
|
650 |
|
Total current assets |
|
31,876 |
|
|
|
23,474 |
|
Property and equipment, net |
|
47 |
|
|
|
50 |
|
Other non-current assets |
|
150 |
|
|
|
150 |
|
Total assets |
$ |
32,073 |
|
|
$ |
23,674 |
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
4,183 |
|
|
$ |
4,271 |
|
Accrued expenses and other current liabilities |
|
2,501 |
|
|
|
3,795 |
|
Deferred revenue |
|
226 |
|
|
|
226 |
|
Total current liabilities |
|
6,910 |
|
|
|
8,292 |
|
Warrant liability |
|
176 |
|
|
|
113 |
|
Deferred revenue, non-current |
|
3,639 |
|
|
|
3,695 |
|
Total liabilities |
|
10,725 |
|
|
|
12,100 |
|
|
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock |
|
- |
|
|
|
- |
|
Common stock |
|
1,674 |
|
|
|
1,112 |
|
Additional paid in capital |
|
428,189 |
|
|
|
413,879 |
|
Accumulated other comprehensive loss |
|
(24 |
) |
|
|
(18 |
) |
Accumulated deficit |
|
(408,491 |
) |
|
|
(403,399 |
) |
Total stockholders' equity |
|
21,348 |
|
|
|
11,574 |
|
Total liabilities and stockholders' equity |
$ |
32,073 |
|
|
$ |
23,674 |
|
|
|
|
|
ONCONOVA THERAPEUTICS,
INC.Condensed Consolidated Statements of
Operations (unaudited)(in thousands, except share and per
share amounts)
|
Three months ended March 31, |
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
Revenue |
$ |
52 |
|
|
$ |
68 |
|
Operating expenses: |
|
|
|
General and administrative |
|
1,807 |
|
|
|
3,234 |
|
Research and development |
|
3,370 |
|
|
|
4,075 |
|
Total operating expenses |
|
5,177 |
|
|
|
7,309 |
|
Loss from operations |
|
(5,125 |
) |
|
|
(7,241 |
) |
|
|
|
|
Change in fair value of warrant liability |
|
(63 |
) |
|
|
(427 |
) |
Interest income |
|
96 |
|
|
|
68 |
|
Net loss |
|
(5,092 |
) |
|
|
(7,600 |
) |
Net loss per share of common stock, basic and diluted |
$ |
(0.03 |
) |
|
$ |
(1.29 |
) |
Basic and diluted weighted average shares outstanding |
|
160,346,087 |
|
|
|
5,890,098 |
|
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