Onconova Therapeutics, Inc. (NASDAQ: ONTX),
a Phase 3 stage biopharmaceutical company focused on developing
rigosertib, a novel small molecule drug candidate to treat cancer, with a
primary focus on Myelodysplastic Syndromes (MDS), today provided a
corporate update and reported financial results for the second quarter
of 2018, ended June 30, 2018. The Company ended the second quarter with
$29.5 million in cash and cash equivalents, which included proceeds from
an underwritten public offering completed in this quarter.
“We
are pleased to have completed our public offering in May, which
included new fundamental institutional biotech investors and broadened
our shareholder base,” commented Dr. Ramesh Kumar, Chief Executive
Officer. “Combined with the financing we completed earlier this year and
a licensing agreement in Latin America with Pint Pharma, we have
significantly strengthened our balance sheet, providing a pathway to
reaching anticipated key milestones in 2018 and 2019.”
Steven
M. Fruchtman, M.D., President, stated, “During the second quarter of
2018, we continued to make progress in our rigosertib clinical programs,
including our IV rigosertib Phase 3 INSPIRE trial for 2nd-line
higher-risk (HR) MDS patients. For this trial, we have opened new sites
in countries already participating and added another country. We expect
to complete the INSPIRE trial in the second half of 2019. After full
enrollment of the Phase 2 oral rigosertib trial in combination with
azacitidine in patients with either 1st-line HR-MDS or those
with azacitidine-resistant disease, we are continuing to collect safety
and efficacy data from this study. The combination trial with
azacitidine is expected to advance to a pivotal Phase 3 trial for 1st-line HR-MDS patients in 2019, pending funding.”
Upcoming Milestones (H2-2018 and 2019)
- Top-line data for the pivotal Phase 3 INSPIRE study, which will be available after 288 death events. Total enrollment is expected to be 360 randomized patients
- Presentation of updated efficacy and safety data from rigosertib/azacitidine combination Phase 2 studies in MDS at a medical meeting
- Regulatory submissions for the Phase 3 trial in MDS of the combination program
- Advance of RASopathy collaborative program to the clinic funded by NCI CRADA
- Investigator initiated studies for rigosertib indications beyond MDS
- IND for Dual CDK 4/6 + ARK5 inhibitor ON 123300 (IND studies funded by HanX Biopharmaceuticals)
Second Quarter Highlights
- In
June, Steven M. Fruchtman, M.D., Chief Medical Officer and Senior Vice
President, Research and Development, was promoted to President. During
his three and a half year tenure, Dr. Fruchtman has been instrumental in
advancing rigosertib to key data milestones. In his new role, Dr.
Fruchtman is now providing leadership across the Company’s entire
product portfolio.
- In May, Onconova strengthened its
balance sheet with the successful completion of a $28.75 million upsized
underwritten public offering. This financing, combined with the $10.0
million offering completed in February 2018, enables the Company to
advance its late-stage programs in MDS to key upcoming milestones; the
start of the combination therapy pivotal studies in MDS will require
additional funding and/or business development transactions.
- ON 123300, a first-in-class dual inhibitor of CDK4/6 + ARK5 has potential applications in a variety of cancers and is advancing toward clinical development in partnership with HanX Biopharmaceuticals, our Greater China collaborator. Following pre-IND consultations with the U.S. Food and Drug Administration, HanX has commenced manufacturing and toxicology studies to support filing of an IND in the U.S.
Second Quarter 2018 Financial Results
Cash
and cash equivalents at June 30, 2018, totaled $29.5 million, compared
to $4.0 million at December 31, 2017. This includes the net proceeds
from the $28.75 million financing completed in May 2018, including the
exercise in full of the underwriter's over-allotment option.
Net
loss was $4.3 million for the second quarter ended June 30, 2018,
compared to a net loss of $2.6 million for the second quarter ended June
30, 2017, primarily due to a $3.5 million gain on the change in warrant
liability in the 2017 period compared to $0.5 million gain in the 2018
period. Research and development expenses were $4.1 million for the
second quarter ended June 30, 2018, and $4.6 million for the comparable
period in 2017. General and administrative expenses were $2.1 million
for the second quarter ended June 30, 2018, and $1.8 million for
comparable period in 2017.
Net loss was $9.4
million for the six months ended June 30, 2018, compared to a net loss
of $10.9 million for the six months ended June 30, 2017, primarily due
to $0.8 million of license fee revenue and $0.9 million less research
and development expenses in the 2018 period.
The
Company will host a conference call on Tuesday, August 14, at 9:00 a.m.
Eastern Time to provide a corporate update and discuss second quarter
2018 financial results. Interested parties may access the call by
dialing toll-free (855) 428-5741 from the U.S., or (210) 229-8823
internationally, and using conference ID: 5287175. The call will also be
webcast live. Please click here to access the webcast. A replay will be available at this link until November 30, 2018.
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.
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.
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).
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 U.S. patent with earliest expiration in 2028.
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(in thousands)
Condensed Consolidated Balance Sheets
(in thousands)
June 30, | December 31, | ||||||||
2018 | 2017 | ||||||||
Assets | (unaudited) | ||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 29,540 | $ | 4,024 | |||||
Receivables | 72 | 59 | |||||||
Prepaid expenses and other current assets | 545 | 820 | |||||||
Total current assets | 30,157 | 4,903 | |||||||
Property and equipment, net | 34 | 64 | |||||||
Other non-current assets | 12 | 12 | |||||||
Total assets | $ | 30,203 | $ | 4,979 | |||||
Liabilities and stockholders' equity | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 5,949 | $ | 6,186 | |||||
Accrued expenses and other current liabilities | 3,572 | 3,335 | |||||||
Deferred revenue | 455 | 455 | |||||||
Total current liabilities | 9,976 | 9,976 | |||||||
Warrant liability | 448 | 1,773 | |||||||
Deferred revenue, non-current | 3,864 | 4,091 | |||||||
Total liabilities | 14,288 | 15,840 | |||||||
Stockholders' deficit: | |||||||||
Preferred stock | - | - | |||||||
Common stock | 851 | 108 | |||||||
Additional paid in capital | 385,966 | 350,514 | |||||||
Accumulated other comprehensive income | (5 | ) | 3 | ||||||
Accumulated deficit | (370,897 | ) | (362,316 | ) | |||||
Total Onconova Therapeutics Inc., stockholders' deficit | 15,915 | (11,691 | ) | ||||||
Non-controlling interest | - | 830 | |||||||
Total stockholders' deficit | 15,915 | (10,861 | ) | ||||||
Total liabilities and stockholders' deficit | $ | 30,203 | $ | 4,979 | |||||
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except share and per share amounts)
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Revenue | $ | 485 | $ | 324 | $ | 1,049 | $ | 534 | |||||||
Operating expenses: | |||||||||||||||
General and administrative | 2,054 | 1,779 | 3,943 | 3,895 | |||||||||||
Research and development | 4,070 | 4,614 | 8,647 | 9,500 | |||||||||||
Total operating expenses | 6,124 | 6,393 | 12,590 | 13,395 | |||||||||||
Income (loss) from operations | (5,639 | ) | (6,069 | ) | (11,541 | ) | (12,861 | ) | |||||||
Gain on dissolution of GBO | 693 | - | 693 | - | |||||||||||
Change in fair value of warrant liability | 513 | 3,474 | 1,325 | 1,925 | |||||||||||
Other income, net | 112 | 11 | 112 | 11 | |||||||||||
Net loss | (4,321 | ) | (2,584 | ) | (9,411 | ) | (10,925 | ) | |||||||
Net loss attributable to non-controlling interest | (163 | ) | - | (163 | ) | - | |||||||||
Net loss applicable to common stockholders | $ | (4,484 | ) | $ | (2,584 | ) | $ | (9,574 | ) | $ | (10,925 | ) | |||
Net loss per share of common stock, basic and diluted | $ | (0.07 | ) | $ | (0.29 | ) | $ | (0.25 | ) | $ | (1.38 | ) | |||
Basic and diluted weighted average shares outstanding | 61,056,072 | 8,999,125 | 38,224,211 | 7,891,408 | |||||||||||
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