Source: Oncovonva Therapeutics, Inc.
Onconova Therapeutics, Inc. (NASDAQ:ONTX),
a Phase 3 stage biopharmaceutical company focused on discovering and
developing novel small molecule drug candidates to treat cancer, with a
primary focus on Myelodysplastic Syndromes (MDS), today provided a
corporate update and reported financial results for the first quarter of
2018 ended March 31, 2018.
“We have
strengthened our balance sheet after completing a $28.75 million upsized
underwritten public offering this month. Combined with the funds raised
in February, we now have the resources necessary to advance our INSPIRE
Phase 3 clinical trial of IV Rigosertib towards complete enrollment,
which we expect in the first half of 2019,” said Dr. Ramesh Kumar,
President and Chief Executive Officer. “After enrollment of our expanded
Phase 2 combination therapy trial and the advance of our CDK inhibitor
preclinical program towards the clinic, we are well-positioned in our
quest to serve the unmet needs of cancer patients.”
Recent Highlights
- In May, we strengthened our balance sheet with a $28.75 million upsized underwritten public offering. This financing, combined with the $10.0 million offering completed in February, should permit the Company to advance its late stage programs in MDS to key milestones;
- We executed a licensing agreement with Pint Pharma to commercialize Rigosertib for treatment of Myelodysplastic Syndromes in Latin America;
- We presented promising Phase 2 data from the expansion study of oral Rigosertib and Azacitidine combination in patients with Myelodysplastic Syndromes at the 6th International Bone Marrow Failure Disease Symposium on March 26th;
- We completed the Pre-IND consultation with the US Food and Drug Administration (FDA) regarding ON 123300, a dual ARK5+CDK4/6 inhibitor, in collaboration with our partner, HanX Biopharmaceuticals. This guidance will help advance our differentiated compound to the clinic;
- We presented data on our first-in-class dual inhibitor of CDK4/6 + ARK5 at the American Association for Cancer Research Annual Meeting 2018 on April 19th.
First Quarter 2018 Financial Results
Cash
and cash equivalents as of March 31, 2018, totaled $7.3 million,
compared to $4.0 million as of December 31, 2017. This excludes the
proceeds from the financing completed in May 2018, in which the Company
raised net proceeds of approximately $25.6 million in a public offering,
including the exercise in full of the underwriter's over-allotment
option. Based on the Company’s current projections, Onconova expects
that cash and cash equivalents will be sufficient to fund ongoing trials
and operations into the fourth quarter of 2019.
Net
loss was $5.1 million for the first quarter ended March 31, 2018,
compared to $8.3 million for the first quarter ended March 31, 2017,
primarily due to a decrease in the fair value of warrant liability, and
the recognition of revenue during the quarter from our license and
collaborative development agreement with HanX Biopharmaceuticals.
Research and development expenses were $4.6 million for the first
quarter ended March 31, 2018, and $4.9 million for the comparable period
in 2017. General and administrative expenses were $1.9 million for the
first quarter ended March 31, 2018, and $2.1 million for comparable
period in 2017.
The Company will host a
conference call on Tuesday, May 15 at 9:00 a.m. Eastern Time to provide a
corporate update and discuss first quarter 2018 financial results.
Interested parties may access the call by dialing toll-free (855)
428-5741 from the US, or (210) 229-8823 internationally and using
conference ID: 2573768. The call will also be webcast live. Please click
here to access the webcast. A replay will be available at this link until August 15, 2018.
About Onconova Therapeutics, Inc.
Onconova
Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company focused
on discovering and developing novel small molecule drug candidates to
treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS).
Rigosertib, Onconova's lead candidate, is a proprietary Phase 3 small
molecule agent, which the Company believes blocks cellular signaling by
targeting RAS effector pathways. Using a proprietary chemistry
platform, Onconova has created a pipeline of targeted agents designed to
work against specific cellular pathways that are important in cancer
cells. Onconova has three product candidates in the clinical stage and
several pre-clinical programs. 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. For more
information, please visit http://www.onconova.com.
About IV Rigosertib
The
intravenous form of rigosertib has been employed in Phase 1, 2, and 3
clinical trials involving more than 800 patients, and is currently being
evaluated in a randomized Phase 3 international INSPIRE trial for
patients with higher-risk MDS, after failure of hypomethylating agent,
or HMA, therapy.
About INSPIRE
The INternational Study of Phase III IV RigosErtib, or INSPIRE,
was finalized following guidance received from the U.S. Food and Drug
Administration and European Medicines Agency and derives from the
findings of the ONTIME Phase 3 trial. INSPIRE is a multi-center,
randomized controlled study to assess the efficacy and safety of IV
rigosertib in HR-MDS patients who had progressed on, failed to respond
to, or relapsed after previous treatment with an HMA within the first 9
months or 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. Following interim analysis in early 2018, the independent
Data Monitoring Committee recommended that the trial continue with an
expansion in enrollment to 360 patients based on a pre-planned sample
size re-estimation. Patients are randomized at a 2:1 ratio into two
treatment arms: IV rigosertib plus Best Supportive Care versus
Physician's Choice plus Best Supportive Care. The primary endpoint of
INSPIRE is overall survival. 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 Rigosertib
The
oral form of rigosertib was developed to provide more convenient dosing
for use where the duration of treatment may extend to multiple years.
This dosage form may also support many combination therapy modalities.
To date, 368 patients have been treated with the oral formulation of
rigosertib. Initial studies with single-agent oral rigosertib were
conducted in hematological malignancies, lower-risk MDS, and solid
tumors. Combination therapy of oral rigosertib with azacitidine and
chemoradiotherapy has also been explored. 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
preliminary results were presented in 2016. This novel combination is
the subject of an issued US patent with earliest expiration in 2028.
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