Onconova Therapeutics Announces Compliance with Nasdaq Bid Price Requirement
August 04 2020 - 08:00AM
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 announced that on August 3,
2020 it received a letter from The Nasdaq Stock Market LLC stating
that the Company had regained compliance with the minimum bid price
requirement of the Nasdaq Listing Rule 5550(a)(2) because
the Company’s common stock had a minimum closing price of at least
$1.00 per share for a minimum ten consecutive business days.
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). Patents covering oral and injectable
rigosertib have been issued in the US and are expected to provide
coverage until at least 2037. Preclinical studies with rigosertib
are underway in COVID-19 as well.
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 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 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, the timing for
data read outs 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.267-759-3680
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
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