-- Merger will combine Oncternal’s clinical
stage oncology pipeline and expertise with GTx’s preclinical
Selective Androgen Receptor Degrader (SARD) program for
castration-resistant prostate cancer --
-- Conference call to be held today at 8:30
a.m. Eastern Time/5:30 a.m. Pacific Time --
GTx, Inc. (Nasdaq: GTXI) and Oncternal Therapeutics,
Inc., a privately held clinical-stage biotechnology company
developing potential first-in-class therapeutic candidates for
cancers with critical unmet medical need, today jointly
announced that they have entered into a definitive merger
agreement under which the stockholders of Oncternal would become
the majority owners of GTx’s outstanding common stock. The proposed
merger will create a publicly-traded, clinical-stage oncology
company.
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The combined company will be named Oncternal Therapeutics, Inc.
and plans to change its ticker symbol on the Nasdaq Capital Market
to ONCT upon closing of the transaction.
The combined company will have a strong balance sheet and deep
pipeline of promising oncology drug programs advancing in
development:
- Oncternal’s lead program, cirmtuzumab,
is an investigational, potential first-in-class anti-ROR1
monoclonal antibody. Cirmtuzumab is currently in a Phase 1/ 2
clinical trial in combination with ibrutinib for the treatment of
chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).
In addition, an investigator-initiated Phase 1 clinical trial of
cirmtuzumab in combination with paclitaxel for women with
metastatic breast cancer is being conducted at the University of
California San Diego (UC San Diego).
- TK216, an investigational, potential
first-in-class small molecule designed to inhibit the biological
activity of ETS-family transcription factor oncoproteins, is being
evaluated alone and in combination with vincristine in a Phase 1
clinical trial in patients with relapsed or refractory Ewing
sarcoma.
- A ROR-1 targeted chimeric antigen
receptor T-cell (CAR-T) program is in preclinical development at UC
San Diego for hematologic and solid tumors.
- A Selective Androgen Receptor Degrader
(SARD) program, an investigational, potential first-in-class
preclinical program designed for oral administration to treat
castration-resistant prostate cancer in men who are non-responsive
to current androgen targeted therapies.
Cash, cash equivalents and short-term investments for the
combined company are expected to be approximately $26 million, if
the merger closes by the end of the second quarter of 2019. These
funds are expected to be sufficient to advance Oncternal’s programs
into the second quarter of 2020, including the Phase 2 study of
cirmtuzumab and ibrutinib, and will fund the planned SARD
preclinical studies to support the submission of an investigational
new drug application with the U.S. Food and Drug
Administration.
James Breitmeyer, MD, PhD, cofounder, president and CEO of
Oncternal and a 30-year veteran of the pharmaceutical industry,
will continue as president and CEO of the combined company. David
Hale, cofounder of Oncternal and a 35-year veteran of numerous
successful private and public biotech companies, will continue as
Chairman of the Board of the combined company.
“This merger introduces Oncternal and its promising oncology
pipeline to the public market and provides additional capital
resources to advance our programs to potential value inflection
points,” said Dr. Breitmeyer. “In addition to clinical data
expected from our cirmtuzumab and TK216 programs later this year
and during the first half of 2020, we also plan to have preclinical
results that get us ready for clinical testing of our ROR1 CAR-T
program. The addition of GTx’s SARD technology strengthens our
pipeline and augments our entire oncology franchise, which includes
a range of therapeutic approaches for a variety of difficult to
treat cancers.”
“This transaction with Oncternal reflects the continued
commitment of our management team and Board of Directors to deliver
value to stockholders and make a difference in patients’ lives,”
said Robert J. Wills, PhD, Executive Chairman of GTx. “Following a
thorough review of strategic alternatives, we have determined that
a reverse merger with Oncternal will enable GTx investors to
participate in Oncternal’s broader pipeline of oncology
opportunities, including product candidates designed to address
rare disease indications, and enable the continued development of
our first-in-class SARD technology by a company whose leadership
has deep experience in developing oncology medicines.”
About the Proposed Merger
The merger is structured as a stock-for-stock transaction
whereby all of Oncternal’s outstanding shares of common stock and
securities convertible into or exercisable for Oncternal’s common
stock will be converted into GTx common stock and securities
convertible into or exercisable for GTx common stock. Immediately
following the closing of the transaction, the former stockholders
of Oncternal will hold approximately 75% of the outstanding shares
of common stock of the combined company. In addition to retaining
an ownership interest representing approximately 25% of the
outstanding shares of common stock of the combined company, the GTx
stockholders of record as of immediately prior to the effective
time of the merger will receive non-transferable contingent value
rights (“CVR”) entitling the holders to receive in the aggregate
50% of any net proceeds derived from the grant, sale or transfer of
rights to SARD or selective androgen receptor modulator (SARM)
technology during the term of the CVR and, if applicable, to
receive royalties on the sale of any SARD products by the combined
company during the term of the CVR. Under certain circumstances
further described in the merger agreement, the exchange ratio of
the outstanding shares of common stock of the combined company may
be adjusted upward or downward based on cash levels of each of the
companies at closing.
Upon closing of the transaction, GTx will be renamed Oncternal
Therapeutics, Inc. and will be headquartered in San Diego,
California under the leadership of Oncternal’s current management
team. Although no GTx employee is expected to remain an employee of
the combined company, the merger agreement provides that the Board
of Directors of the combined company will be comprised of nine
members, including seven designated Oncternal directors as well as
Robert J. Wills, PhD and Michael G. Carter, MD, from GTx’s current
Board. The combined company is expected to trade on The Nasdaq
Capital Market under a new ticker symbol, ONCT. The merger
agreement has been unanimously approved by the Board of Directors
of each company. The transaction is expected to close in the second
quarter of 2019, subject to approvals by stockholders of each
company and other customary closing conditions.
Aquilo Partners, L.P. is acting as exclusive financial advisor
to GTx on the proposed transaction and Cooley LLP serves as legal
counsel to GTx. Piper Jaffray is acting as exclusive financial
advisor to Oncternal on the proposed transaction and Latham &
Watkins, LLP serves as legal counsel to Oncternal.
Conference Call Information
Dr. Wills and Dr. Breitmeyer will co-host a conference call to
discuss the proposed merger on March 7, 2019, at 5:30 A.M. Pacific
Time at Oncternal’s headquarters in San Diego.
To access the live conference call, please dial 1.877.407.2991
from the U.S. and Canada or 1.201.389.0925 internationally. A
playback of the call will be available from approximately 12:00
P.M. Pacific Time today through May 7, 2019 and may be accessed by
dialing 877.660.6853 from the U.S. and Canada or 201.612.7415
internationally, and using conference ID 13688553. The conference
call information will also be available on the Investor section of
the GTx website at www.gtxinc.com.
About GTx
GTx, Inc., headquartered in Memphis, Tenn., is a
biopharmaceutical company dedicated to the discovery, development
and commercialization of small molecules for the treatment of
muscle-related diseases and other serious medical conditions.
About Oncternal Therapeutics
Oncternal Therapeutics is a clinical-stage oncology company
developing novel, potential first-in-class therapeutic candidates
for cancers with critical unmet medical need. The company is
leveraging its scientific and development expertise, as well as
academic collaborations, to rapidly advance its pipeline.
About Cirmtuzumab
Cirmtuzumab is an investigational, potential first-in-class
humanized monoclonal antibody that is designed to bind with high
affinity to a biologically important epitope on ROR1
(Receptor-tyrosine kinase-like Orphan Receptor 1). Cirmtuzumab has
been developed in collaboration with UC San Diego, and with the
California Institute for Regenerative Medicine (CIRM), which funded
both previous preclinical development work, as well as previous and
ongoing clinical trials. ROR1 is a type 1 transmembrane protein
expressed on the plasma membrane with an extracellular domain that
is essential for ligand binding and signal transduction. In
preclinical studies, it has been observed to bind to many different
types of cancer cells, but not to most normal human tissues. Tumor
cells that express ROR1 have tumor-initiating features that are
associated with a de-differentiated oncogenic state. When expressed
by hematologic malignancies such as mantle cell lymphoma (MCL),
chronic lymphocytic leukemia (CLL), and small lymphocytic leukemia
(SLL), ROR1 has been observed to act as a receptor for the tumor
growth factor Wnt5a. Cirmtuzumab is designed to bind to ROR1 in
such a manner that it blocks Wnt5a activation and inhibits
tumor-cell proliferation, migration and survival and induces
differentiation. Early clinical data suggests that cirmtuzumab may
synergize with ibrutinib, and Oncternal is evaluating this pairing
as a potential combination treatment for CLL and MCL.
About TK216
TK216 is an investigational, potential first-in-class small
molecule that is designed to inhibit the biological activity of
ETS-family transcription factor oncoproteins in a variety of tumor
types, in an effort to inhibit cancer cell growth and tumor
formation. In Ewing sarcoma, it is designed to target the
well-characterized fusion proteins that cause the disease. TK216 is
being developed collaboratively by Georgetown University and
Oncternal. Oncternal is also planning clinical studies of TK216 in
leukemia and performing preclinical studies in prostate cancer.
Additional Information about the Proposed Merger and Where to
Find It
In connection with the proposed merger, GTx and Oncternal intend
to file relevant materials with the Securities and Exchange
Commission, or the SEC, including a registration statement on Form
S-4 that will contain a prospectus, a proxy statement and an
information statement. Investors and security holders of GTx and
Oncternal are urged to read these materials when they become
available because they will contain important information about
GTx, Oncternal and the merger. The proxy statement, prospectus,
information statement and other relevant materials (when they
become available), and any other documents filed by GTx with the
SEC, may be obtained free of charge at the SEC web site at
www.sec.gov. In addition, investors and security holders may obtain
free copies of the documents filed with the SEC by GTx by directing
a written request to: GTx, Inc., 175 Toyota Plaza, 7th Floor,
Memphis, Tennessee 38103, Attention: Corporate Secretary. Investors
and security holders are urged to read the proxy statement,
prospectus, information statement and other relevant materials when
they become available before making any voting or investment
decision with respect to the merger.
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering of securities
shall be made except by means of a prospectus meeting the
requirements of Section 10 of the Securities Act of 1933, as
amended.
Participants in the Solicitation
GTx and its directors and executive officers and Oncternal and
its directors and executive officers may be deemed to be
participants in the solicitation of proxies from the stockholders
of GTx in connection with the proposed transaction. Information
regarding the special interests of these directors and executive
officers in the merger will be included in the proxy statement/
prospectus/information statement referred to above. Additional
information regarding the directors and executive officers of GTx
is also included in GTx’s definitive proxy statement in connection
with its 2018 Annual Meeting of Stockholders filed with the SEC on
March 23, 2018. These documents are available free of charge at the
SEC web site (www.sec.gov) and from the Corporate Secretary of GTx
at the address above.
GTx Forward-Looking Information is Subject to Risks and
Uncertainty
This press release contains forward-looking statements based
upon GTx’s and Oncternal’s current expectations. Forward-looking
statements involve risks and uncertainties, and include, but are
not limited to, statements about the structure, timing and
completion of the proposed merger; the combined company's listing
on Nasdaq after closing of the proposed merger; the timing and
results of planned preclinical studies or clinical trials of
cirmtuzumab, TK216 or Oncternal’s ROR-1 targeted CAR-T product
candidates; the possibility that any grant, sale or transfer of
rights to SARD or SARM technology or the sale of any SARD or SARM
products will occur during the term of the CVR and that the
conditions to payment under the CVRs will be met; expectations
regarding the ownership structure of the combined company; the
combined company’s expected cash position at the closing of the
proposed merger; the future operations of the combined company,
including with respect to the continued development of GTx’s SARD
technology; the nature, strategy and focus of the combined company;
the development and commercial potential and potential benefits of
any product candidates of the combined company; the executive and
board structure of the combined company; the location of the
combined company's corporate headquarters; anticipated preclinical
and clinical drug development activities and related timelines,
including the expected timing for data and other clinical and
preclinical results; Oncternal having sufficient resources to
advance its pipeline; and other statements that are not historical
fact. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation: (i) the risk that the conditions to
the closing of the proposed merger are not satisfied, including the
failure to timely obtain stockholder approval for the transaction,
if at all; (ii) uncertainties as to the timing of the consummation
of the proposed merger and the ability of each of GTx and Oncternal
to consummate the proposed merger; (iii) risks related to GTx’s
ability to manage its operating expenses and its expenses
associated with the proposed merger pending closing; (iv) risks
related to the failure or delay in obtaining required approvals
from any governmental or quasi-governmental entity necessary to
consummate the proposed merger; (v) the risk that as a result of
adjustments to the exchange ratio, GTx stockholders and Oncternal
stockholders could own more or less of the combined company than is
currently anticipated; (vi) risks related to the market price of
GTx’s common stock relative to the exchange ratio; (vii) unexpected
costs, charges or expenses resulting from the transaction; (viii)
potential adverse reactions or changes to business relationships
resulting from the announcement or completion of the proposed
merger; (ix) the uncertainties associated with the clinical
development and regulatory approval of product candidates such as
cirmtuzumab and TK216, including potential delays in the
commencement, enrollment and completion of clinical trials; (x)
risks related to the inability of the combined company to obtain
sufficient additional capital to continue to advance these product
candidates and its preclinical programs, including GTx’s SARD
program and Oncternal’s CAR-T program; (xi) uncertainties in
obtaining successful clinical results for product candidates and
unexpected costs that may result therefrom; (xii) risks related to
the failure to realize any value from product candidates and
preclinical programs being developed and anticipated to be
developed in light of inherent risks and difficulties involved in
successfully bringing product candidates to market; (xiii) the risk
that the conditions to payment under the CVRs will be not be met
and that the CVRs may otherwise never deliver any value to GTx
stockholders; and (xiv) risks associated with the possible failure
to realize certain anticipated benefits of the proposed merger,
including with respect to future financial and operating results.
Actual results and the timing of events could differ materially
from those anticipated in such forward-looking statements as a
result of these risks and uncertainties. These and other risks and
uncertainties are more fully described in periodic filings with the
SEC, including the factors described in the section entitled “Risk
Factors” in GTx’s Quarterly Report on Form 10-Q for the quarter
ended September 30, 2018 filed with the SEC, and in other filings
that GTx makes and will make with the SEC in connection with the
proposed transactions, including the proxy statement/prospectus
described above under "Additional Information about the Proposed
Merger and Where to Find It." You should not place undue reliance
on these forward-looking statements, which apply only as of the
date of this press release. GTx expressly disclaims any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in its expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are
based.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190307005220/en/
GTx, Inc.InvestorsMarc
Hanover901-523-9700mhanover@gtxinc.comMediaDenise
Powell510-703-9491denise@redhousecomms.comOncternal
Contacts:InvestorsRichard
Vincent858-434-1113rvincent@oncternal.comMediaJason
Spark619-849-6005jason@canalecomm.com
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