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 June 30, 2020, and provided a business
update.
“With INSPIRE recently meeting the number of
survival events required by the study’s statistical analysis plan,
we anticipate reporting topline data by the end of the current
quarter,” said Steven M. Fruchtman, M.D., President and Chief
Executive Officer. “If the data readout demonstrates a significant
prolongation of survival for patients randomized to intravenous
rigosertib, we believe this could represent a significant medical
advancement for patients with higher-risk MDS. Following such data
readout, we anticipate submitting a New Drug Application to the FDA
to seek approval to commercially launch rigosertib.”
Second Quarter 2020 Developments and
Recent Highlights
- Pivotal Phase 3 INSPIRE trial reached the required number of
survival events for data analysis
- Initiation of and first patient enrollment in a Phase 1/2a
study exploring an oral rigosertib plus nivolumab combination in
KRAS+ lung cancer patients
- Applications submitted for rigosertib to participate in
federally funded human studies in COVID-19 disease based on
early-stage preclinical evidence of rigosertib inhibition of
SARS-COV-2 replication
- Election of life sciences industry veteran Terri Shoemaker to
the Company’s Board of Directors
- Nasdaq compliance regained with achievement of dollar bid price
listing requirement
Recent Presentations and Scientific
Publications
- Presentation of updated aggregated baseline genomic data from
HMA-failure patients screened and randomized for the INSPIRE trial,
in e-poster form, at the virtual 25th Annual European Hematology
Association (EHA) Congress
- Publication in Molecular Cell of preclinical data supporting
rigosertib’s mechanism of action as a targeted anticancer
agent
- Publication of Phase 1 results in Leukemia Research for oral
rigosertib in combination with azacitidine in higher-risk (HR)-MDS
and acute leukemia
Additional Expected Company
Milestones
- Announcement of topline INSPIRE results by the end of the third
quarter of 2020, with data presentation at a major medical meeting
later in the year
- FDA review of Phase 2/3 trial protocol of oral rigosertib plus
azacitidine in hypomethylating agent (HMA) naïve HR-MDS
- Federal funding agencies review of applications for clinical
trials with rigosertib in SARS-COV-2 disease
- Virtual presentation at the 2nd Annual RAS-Targeted Drug
Development Summit September 14-16, 2020
- US IND submission planned for 4Q 2020 for next generation CDK
4/6 + ARK5 inhibitor, ON 123300, with first in-human Phase 1 trial
anticipated in 1Q 2021, and Phase 1 study commencement in China
planned for 2H 2020
- Anticipated launch of Early Access Program with Inceptua
Medicines Group in 2H 2020
- Expansion of rigosertib investigator-initiated development
program to encompass additional RAS-driven cancers
Second Quarter 2020 Financial
ResultsCash and cash equivalents as of June 30, 2020,
totaled $27.2 million, compared to $22.7 million as of December 31,
2019. Exercises of common stock warrants from our financing
transactions in November and December 2019 have added $9.8 million
to our balance sheet since January 1, 2020, and as of August 12,
2020, we have 183,578,267 common shares outstanding. Of the 12.6
million common stock warrants which remain outstanding at August
12, 2020, 80% were in-the-money. Based on current projections, the
Company expects that its cash and cash equivalents will be
sufficient to fund ongoing trials and operations into the fourth
quarter of 2021.
Net loss was $7.4 million for the quarter ended
June 30, 2020, compared to $3.6 million for the quarter ended June
30, 2019. Research and development expenses were $4.8 million for
the quarter ended June 30, 2020 and $3.9 million for the comparable
period in 2019. General and administrative expenses were $2.6
million for the quarter ended June 30, 2020 and $1.8 million for
the comparable period in 2019.
Conference Call and Webcast
InformationThe Company will host a conference call today,
August 12, 2020, at 4:30 p.m. Eastern Time. Interested parties who
wish to participate in the conference call may do so by dialing
(855) 428-5741 for domestic and (210) 229-8823 for international
callers and using conference ID 2875654.
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.
Those interested in listening to the conference
call via the internet may do so by visiting the investors and media
page on the company's website at www.onconova.com and clicking on
the webcast link. In addition to the live webcast, a replay will be
available on the Onconova website for 90 days following the
call.
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 additional
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 naive and refractory higher-risk
MDS patients (Phase 2). Preclinical studies with rigosertib are
underway in COVID-19 as well. 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, 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 RigosertibThe
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 RigosertibThe 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.
About SARS-CoV-2 and
COVID-19Severe acute respiratory syndrome due to
SARS-CoV-2 has impacted millions of people worldwide and has led to
the death of hundreds of thousands of individuals. Collaborative
efforts to test many experimental and health authority approved
agents are ongoing worldwide to address the global pandemic through
the development of therapeutic antiviral drugs to treat COVID-19
infection, and with vaccines to prevent infection with
SARS-CoV-2.
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 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 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.267-759-3680
ir@onconova.us https://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
ONCONOVA THERAPEUTICS,
INC.Condensed Consolidated Balance
Sheets(in thousands)
|
June
30, |
|
December
31, |
|
|
2020 |
|
|
|
2019 |
|
Assets |
(unaudited) |
|
|
Current
assets: |
|
|
|
Cash
and cash equivalents |
$ |
27,228 |
|
|
$ |
22,726 |
|
Receivables |
|
41 |
|
|
|
98 |
|
Prepaid expenses and other current assets |
|
720 |
|
|
|
650 |
|
Total
current assets |
|
27,989 |
|
|
|
23,474 |
|
Property and
equipment, net |
|
60 |
|
|
|
50 |
|
Other
non-current assets |
|
150 |
|
|
|
150 |
|
Total
assets |
$ |
28,199 |
|
|
$ |
23,674 |
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
5,148 |
|
|
$ |
4,271 |
|
Accrued expenses and other current liabilities |
|
3,377 |
|
|
|
3,795 |
|
Deferred revenue |
|
226 |
|
|
|
226 |
|
Total
current liabilities |
|
8,751 |
|
|
|
8,292 |
|
Warrant
liability |
|
232 |
|
|
|
113 |
|
Deferred
revenue, non-current |
|
3,583 |
|
|
|
3,695 |
|
Total
liabilities |
|
12,566 |
|
|
|
12,100 |
|
|
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock |
|
- |
|
|
|
- |
|
Common stock |
|
1,742 |
|
|
|
1,112 |
|
Additional paid in capital |
|
429,794 |
|
|
|
413,879 |
|
Accumulated other comprehensive income |
|
(17 |
) |
|
|
(18 |
) |
Accumulated deficit |
|
(415,886 |
) |
|
|
(403,399 |
) |
Total
stockholders' equity |
|
15,633 |
|
|
|
11,574 |
|
Total
liabilities and stockholders' equity |
$ |
28,199 |
|
|
$ |
23,674 |
|
|
|
|
|
ONCONOVA THERAPEUTICS,
INC.Condensed Consolidated Statements of
Operations (unaudited)(in thousands, except share and per
share amounts)
|
Three Months Ended June 30, |
|
Six months months ended June 30, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
Revenue |
$ |
56 |
|
|
$ |
2,022 |
|
|
$ |
108 |
|
|
$ |
2,090 |
|
Operating
expenses: |
|
|
|
|
|
|
|
General and administrative |
|
2,594 |
|
|
|
1,760 |
|
|
|
4,401 |
|
|
|
4,994 |
|
Research and development |
|
4,801 |
|
|
|
3,895 |
|
|
|
8,171 |
|
|
|
7,969 |
|
Total
operating expenses |
|
7,395 |
|
|
|
5,655 |
|
|
|
12,572 |
|
|
|
12,963 |
|
Loss from
operations |
|
(7,339 |
) |
|
|
(3,633 |
) |
|
|
(12,464 |
) |
|
|
(10,873 |
) |
|
|
|
|
|
|
|
|
Change in
fair value of warrant liability |
|
(56 |
) |
|
|
32 |
|
|
|
(119 |
) |
|
|
(395 |
) |
Other
income, net |
|
- |
|
|
|
40 |
|
|
|
96 |
|
|
|
107 |
|
Net
loss |
|
(7,395 |
) |
|
|
(3,561 |
) |
|
|
(12,487 |
) |
|
|
(11,161 |
) |
Net loss per
share of common stock, basic and diluted |
$ |
(0.04 |
) |
|
$ |
(0.60 |
) |
|
$ |
(0.08 |
) |
|
$ |
(1.89 |
) |
Basic and
diluted weighted average shares outstanding |
|
169,552,619 |
|
|
|
5,948,471 |
|
|
|
164,949,353 |
|
|
|
5,919,446 |
|
|
|
|
|
|
|
|
|
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