- Interim objective response rate of 100% in evaluable patients
with CLL receiving the recommended dosing regimen of cirmtuzumab +
ibrutinib supports opening Phase 2
- Two product candidates moving forward in clinical trials
- Conference call today at 5:00 p.m. EDT
SAN DIEGO, August 8, 2019 -- Oncternal
Therapeutics, Inc., (Nasdaq: ONCT) a clinical-stage biotechnology
company developing potential first-in-class product candidates for
cancers with critical unmet medical needs, today announced
financial results for the second quarter, which ended June 30,
2019, and provided a business update.
“Oncternal is thrilled to provide its first quarterly results as
a Nasdaq-listed Company. We are making great progress
developing our clinical and preclinical programs as we head into
the second half of 2019,” said James Breitmeyer, M.D., Ph.D.,
Oncternal’s President and CEO. “We are very encouraged by initial
results from our lead clinical program’s Phase 1/2 study of
cirmtuzumab in combination with ibrutinib in patients with chronic
lymphocytic leukemia, and excited to be opening the randomized
Phase 2 portion of the study. The early results for cirmtuzumab in
combination with ibrutinib in patients with mantle cell lymphoma
are also encouraging, and we expect to report data in this patient
population before the end of the year. With respect to our other
pipeline programs, our clinical study of TK216 in combination with
vincristine in patients with Ewing sarcoma is advancing as planned,
and we expect to begin enrolling patients in an expansion cohort of
this study soon. Finally, we anticipate selecting a construct for
IND-enabling studies of our ROR1 CAR-T program before the end of
this year.”
Recent Corporate Highlights
- In August 2019, Oncternal announced it has opened for
enrollment its randomized Phase 2 study of cirmtuzumab, a
ROR1-targeted monoclonal antibody, combined with ibrutinib in
patients with chronic lymphocytic leukemia (CLL). The decision to
open the Phase 2 portion of the Company’s ongoing Phase 1/2 CIRLL
(Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and
Lymphoma) clinical trial was triggered by favorable outcomes from
the Part 1 dose-finding and Part 2 dose-confirming cohorts of the
clinical trial, including the recently announced interim objective
response rate (ORR) of 100% for the first nine CLL patients with
evaluable data receiving the recommended dosing regimen who have
completed 12 weeks of cirmtuzumab plus ibrutinib treatment in Part
2. The Company continues to see a well-tolerated safety profile
consistent with that seen with ibrutinib treatment alone.
- In June 2019, Oncternal announced that the reverse merger
between GTx, Inc., GTx’s merger subsidiary and privately-held
Oncternal Therapeutics, Inc., had closed and the combined company
was renamed Oncternal Therapeutics, Inc. Trading on the Nasdaq
stock exchange under the ticker symbol “ONCT” began on June
10, 2019. The closing of the merger was a transformative event that
the Company believes will allow it to pursue its next level of
corporate growth and continue to advance its oncology drug
candidates in multiple cancer indications.
- In June 2019, Oncternal presented interim data from its ongoing
Phase 1/2 study of cirmtuzumab in combination with ibrutinib at the
2019 American Society of Clinical Oncology (ASCO) Annual Meeting –
the largest oncology conference of the year. Results from the first
12 patients with CLL treated in the Part 1 dose-finding portion of
the Phase 1 study showed an interim ORR of 91.7% for the
combination of cirmtuzumab plus ibrutinib, including three patients
with clinical or confirmed complete responses, and a well-tolerated
safety profile consistent with that seen for ibrutinib treatment
alone.
- Oncternal also disclosed at the ASCO meeting that six patients
with mantle cell lymphoma (MCL), had been treated in a separate
cohort of the CIRLL study. One patient with MCL who had relapsed
following an allogeneic stem cell transplant experienced a
confirmed complete response (CR) after 3 months of cirmtuzumab plus
ibrutinib treatment, including complete resolution of a large
mediastinal mass. This CR appears to be durable, and has been
confirmed after 6, 9 and 11 months of cirmtuzumab plus ibrutinib
treatment.
Expected Upcoming Milestones
- Cirmtuzumab Program
- Oncternal anticipates reporting additional data from its Phase
1/2 study of cirmtuzumab in combination with ibrutinib from
patients with CLL at a scientific conference in the fourth quarter
of 2019
- Oncternal anticipates reporting additional data from its Phase
1/2 study of cirmtuzumab in combination with ibrutinib from
patients with MCL at a scientific conference in the fourth quarter
of 2019
- Oncternal anticipates reporting data from its Phase 1 study of
cirmtuzumab in combination with paclitaxel from patients with
breast cancer at a scientific conference in the fourth quarter of
2019
- TK216 Program
- Oncternal anticipates completing the dose finding portion of
its Phase 1 study of TK216 for patients with Ewing sarcoma and
opening the expansion cohort in the third quarter of 2019
- Oncternal anticipates reporting data from its Phase 1 study of
TK216 from patients with Ewing sarcoma at a scientific conference
in the fourth quarter of 2019
- ROR1 CAR-T Program
- Oncternal anticipates selecting a candidate CAR-T construct for
IND-enabling studies in hematologic cancers in the second half of
2019, and opening clinical trials for hematological cancers in
2020
- Oncternal anticipates selecting a candidate CAR-T construct for
IND-enabling studies in solid tumors in 2020
Financial ResultsOn June 7, 2019, the former
privately-held Oncternal Therapeutics, Inc. (“Private Oncternal”),
completed a reverse merger transaction with GTx, Inc. and its
merger subsidiary. Under the merger agreement, a wholly-owned
subsidiary of GTx, Inc. merged with and into Private Oncternal,
with Private Oncternal surviving as a wholly-owned subsidiary of
the merged parent company. The surviving parent entity changed its
corporate name from GTx, Inc. to Oncternal Therapeutics, Inc., and
commenced trading on the Nasdaq stock exchange under the ticker
symbol “ONCT.”
The transaction was accounted for as a reverse asset acquisition
in accordance with generally accepted accounting principles. Under
this method of accounting, Private Oncternal was deemed to be the
accounting acquirer for financial reporting purposes. As a result,
effective as of the closing date of the merger, the reported
historical operating results prior to the merger closing date will
be those of Private Oncternal. Information regarding the reverse
merger transaction and our financial results is also included on
form 10-Q to be filed with the SEC.
Grant revenue was $0.7 million for the quarter
ended June 30, 2019. Our grant revenue is derived from a
California Institute for Regenerative Medicine (CIRM) grant
subaward with the University of California, San Diego. The grant
was awarded to advance our lead program in a Phase 1/2 clinical
trial evaluating cirmtuzumab in combination with ibrutinib for the
treatment of patients with B-cell lymphoid malignancies CLL and
MCL.
Total operating expenses for the second quarter ended June 30,
2019 were $22.3 million, which included in-process research and
development expenses of $18.1 million that was recorded in
connection with the closing of our merger transaction in June
2019.
Research and development expenses for the quarter totaled $2.6
million.
General and administrative expenses for the quarter totaled $1.6
million.
Including the one-time merger charge, net loss for the second
quarter was $22.8 million, or a loss of $3.38 per share,
basic and diluted.
As of June 30, 2019, Oncternal has $28.5 million in cash and
cash equivalents. The Company believes these funds will be
sufficient to fund its operations into the second quarter of 2020.
As of June 30, 2019, we had 15.4 million shares of common stock
outstanding.
Oncternal Management Hosting Conference Call and Live
Webcast Oncternal will host a conference call
today, August 8, 2019, at 2:00 p.m. PDT (5:00 p.m.
EDT) to review quarterly results and provide an update on
clinical and preclinical development programs. A live webcast of
the call will be available online and may be accessed from the
“Investors” page of the company website
at http://investor.oncternal.com/. A replay of the webcast
will be available beginning approximately one hour after the
conclusion of the call and will remain available for at least 30
days thereafter.
About Oncternal Therapeutics Oncternal
Therapeutics is a clinical-stage biopharmaceutical company focused
on developing a diverse pipeline of product candidates for the
treatment of cancers with critical unmet medical need. Oncternal
focuses drug development on promising yet untapped biological
pathways implicated in cancer generation and progression. The
pipeline includes its lead clinical program, cirmtuzumab, a
monoclonal antibody designed to inhibit the ROR1 receptor that is
being evaluated in a Phase 1/2 clinical trial in combination with
ibrutinib for the treatment of CLL and MCL, and TK216, a
small-molecule compound that is designed to inhibit ETS-family
oncoproteins, which is being evaluated in a Phase 1 clinical trial
alone and in combination with vincristine as a treatment for Ewing
sarcoma, a rare pediatric cancer. In addition, Oncternal has
a CAR-T program targeting ROR1, which is currently in
preclinical development as a potential treatment for hematologic
cancers and solid tumors. More information is available
at www.oncternal.com.
Forward-Looking Information Oncternal cautions
you that statements included in this press release that are not a
description of historical facts are forward-looking statements. In
some cases, you can identify forward-looking statements by terms
such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,”
“could,” “intend,” “target,” “project,” “contemplates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negatives
of these terms or other similar expressions. These statements are
based on the Company’s current beliefs and expectations.
Forward looking statements include statements regarding:
Oncternal’s belief that favorable outcomes from the ongoing Phase 1
portion of the CIRLL clinical trial support opening the randomized
Phase 2 portion; Oncternal’s plans for enrolling patients in, and
presenting data from its clinical studies of cirmtuzumab and TK216;
the anticipated timing of initiation and enrollment of clinical
trials for our product candidates; expectations on the timing of
data readouts from our clinical studies and presentation of such
results at scientific conferences; plans to select a construct for
IND-enabling studies of our ROR1 CAR-T program or otherwise advance
our programs; the Company’s belief that the closing of the merger
was a transformative event that will allow it to pursue its
next level of corporate growth and continue to advance its oncology
drug candidates in multiple cancer indications, and that it has
sufficient funds to fund its development programs and operations
into the second quarter of 2020. The inclusion of forward-looking
statements should not be regarded as a representation by Oncternal
that any of its plans will be achieved. Actual results may differ
from those set forth in this release due to the risks and
uncertainties inherent in Oncternal’s business, including, without
limitation: uncertainties associated with the clinical development
and process for obtaining regulatory approval of cirmtuzumab, TK216
and Oncternal’s other product candidates, including potential
delays in the commencement, enrollment and completion of clinical
trials; Oncternal’s dependence on the success of cirmtuzumab, TK216
and its other product development programs; the risk that interim
results of a clinical trial do not necessarily predict final
results and that one or more of the clinical outcomes may
materially change as patient enrollment continues, following more
comprehensive reviews of the data, and as more patient data become
available; the risk that unforeseen adverse reactions or side
effects may occur in the course of developing and testing product
candidates such as cirmtuzumab and Oncternal’s other product
candidates; Oncternal’s limited operating history and the fact that
it has incurred significant losses, and expects to continue to
incur significant losses for the foreseeable future; risks related
to the inability of Oncternal to obtain sufficient additional
capital to continue to advance the development of cirmtuzumab,
TK216 and its other product candidates; and other risks described
in Oncternal’s prior press releases as well as in public periodic
filings with the U.S. Securities & Exchange Commission. All
forward-looking statements in this press release are current only
as of the date hereof and, except as required by applicable law,
Oncternal undertakes no obligation to revise or update any
forward-looking statement, or to make any other forward-looking
statements, whether as a result of new information, future events
or otherwise. All forward-looking statements are qualified in their
entirety by this cautionary statement. This caution is made under
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995.
Oncternal Contacts:
Investors Richard Vincent
858-434-1113 rvincent@oncternal.com
Media Jason Spark619-849-6005
jason@canalecomm.com
Oncternal Therapeutics, Inc. Condensed Consolidated
Balance Sheets Data (in thousands)
|
June 30,2019 |
|
|
December 31,2018 |
|
|
(Unaudited) |
|
|
|
|
|
Cash and cash equivalents |
$ |
28,516 |
|
|
$ |
20,645 |
|
Total assets |
|
30,903 |
|
|
|
21,962 |
|
Total liabilities |
|
7,967 |
|
|
|
5,005 |
|
Accumulated deficit |
|
(56,524 |
) |
|
|
(31,384 |
) |
Total convertible preferred stock
and stockholders’ equity (deficit) |
|
22,936 |
|
|
|
16,957 |
|
|
|
|
|
|
|
|
|
Oncternal Therapeutics, Inc. Condensed Consolidated
Statements of Operations Data (Unaudited; in thousands, except per
share data
|
Three Months EndedJune 30, |
|
|
Six Months
EndedJune 30, |
|
|
2019 |
|
2018 |
|
|
2019 |
|
2018 |
|
Grant revenue |
$ |
|
674 |
|
|
$ |
|
1,527 |
|
|
$ |
|
1,144 |
|
|
$ |
|
1,715 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
2,587 |
|
|
|
|
3,513 |
|
|
|
|
4,483 |
|
|
|
|
4,802 |
|
In-process research and
development |
|
|
18,088 |
|
|
|
|
— |
|
|
|
|
18,088 |
|
|
|
|
— |
|
General and administrative |
|
|
1,619 |
|
|
|
|
555 |
|
|
|
|
2,551 |
|
|
|
|
1,136 |
|
Total operating expenses |
|
|
22,294 |
|
|
|
|
4,068 |
|
|
|
|
25,122 |
|
|
|
|
5,938 |
|
Loss from operations |
|
|
(21,620 |
) |
|
|
|
(2,541 |
) |
|
|
|
(23,978 |
) |
|
|
|
(4,223 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of warrant liability |
|
|
(1,285 |
) |
|
|
|
114 |
|
|
|
|
(1,268 |
) |
|
|
|
77 |
|
Other income |
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
216 |
|
Interest expense |
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
(1 |
) |
Interest income |
|
|
59 |
|
|
|
|
15 |
|
|
|
|
106 |
|
|
|
|
28 |
|
Total other income (expense) |
|
|
(1,226 |
) |
|
|
|
129 |
|
|
|
|
(1,162 |
) |
|
|
|
320 |
|
Net loss |
$ |
|
(22,846 |
) |
|
$ |
|
(2,412 |
) |
|
$ |
|
(25,140 |
) |
|
$ |
|
(3,903 |
) |
Net loss per share, basic and
diluted |
$ |
|
(3.38 |
) |
|
$ |
|
(0.68 |
) |
|
$ |
|
(4.81 |
) |
|
$ |
|
(1.10 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
|
6,765 |
|
|
|
|
3,573 |
|
|
|
5,229 |
|
|
|
|
3,555 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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