Boston (December 12, 2023) —
Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ:
ALLR), a clinical-stage pharmaceutical company developing novel
oncology therapeutics together with drug-specific DRP® companion
diagnostics for personalized cancer care, today announced a
transition in its leadership. Effective immediately, James G.
Cullem is no longer President and CEO. The Company also announced
that Thomas H. Jensen, co-founder and member of the Board of
Directors of Allarity Therapeutics, has been appointed as Interim
Chief Executive Officer. The Company has also engaged Jeremy R.
Graff, Ph.D., as an Executive Advisor. Dr. Graff will work closely
with Mr. Jensen and the Board to provide consulting and advisory
services on Allarity’s research and development programs in the
field of small molecule inhibitors and their use in the treatment
of cancer.
As a co-founder of Allarity Therapeutics with nearly two decades
of dedicated service, Thomas H. Jensen brings a wealth of
experience and expertise to his new role as Interim CEO, rooted in
his deep understanding of the Company’s development of its DRP®
companion diagnostic technology.
In addition to his technological contributions, Mr. Jensen has
been instrumental in building the Company’s investor relations
operations, securing operational financing, and fostering its
overall business progress. His expertise extends to the development
of molecular biological techniques for high-quality, reproducible
RNA extraction and downstream processing. These innovations are
foundational to the DRP® platform, a core aspect of Allarity’s
effort to realize personalized cancer care.
Jerry McLaughlin, Chairman of the Board of Allarity
Therapeutics, expressed his gratitude to James G. Cullem for his
contributions and added, “We are confident in Thomas H. Jensen’s
ability to lead Allarity during this transition. With his deep
understanding of the Company’s mission, its team, and technology,
we look forward to a smooth and successful leadership change.”
Commenting on his appointment as Interim CEO, Thomas H. Jensen
stated, “I am honored to take on the role of Interim CEO at
Allarity Therapeutics. We have a strong team in place, and I am
committed to continuing our mission of advancing personalized
cancer care. I would also like to extend my appreciation to James
G. Cullem for his dedicated service during this tenure as CEO and
in his previous capacities within the Company.”
Additionally, Allarity Therapeutics announced the engagement of
Jeremy R. Graff, Ph.D., to serve as an Executive Advisor to the CEO
and Board of Directors. Dr. Graff brings over 25 years of
experience in the biotech and pharma industry, with a remarkable
track record in the development of targeted cancer therapies.
Previously, Dr. Graff held C-level and senior executive positions
at various biotechnology companies. During his nearly 17-year
tenure at Eli Lilly and Company, Dr. Graff identified and validated
new molecular targets for advanced cancers, working alongside the
clinical development team to establish and lead the translational
oncology group. This group supported and advanced the 31 clinical
assets in Eli Lilly’s oncology portfolio at the time. Dr. Graff
also serves as a member of the Board of Directors of IN8bio, Inc.,
a member of the Board of Trustees for the Wood Hudson Cancer
Research Laboratory, and is on the Scientific Advisory Board of
Avicenna Biosciences, Inc. He completed a post-doctoral fellowship
at the Johns Hopkins University School of Medicine. Dr. Graff’s
contributions to the field of oncology are underscored by his
numerous publications, patents, and affiliations with esteemed
organizations. His expertise and guidance will play a pivotal role
in advancing Allarity’s research and development programs in the
field of small molecule inhibitors for cancer treatment.
About Allarity Therapeutics Allarity
Therapeutics, Inc. (Nasdaq: ALLR) develops drugs for personalized
treatment of cancer guided by its proprietary and highly validated
companion diagnostic technology, the DRP® platform. The
Company’s lead program, stenoparib, is a differentiated
PARP/Tankyrase dual inhibitor currently in Phase 2 development for
ovarian cancer where patients are prospectively selected using the
stenoparib DRP® diagnostic, and in Phase 1 development for advanced
solid tumors in monotherapy and combination settings. The Company’s
other programs include dovitinib, a pan-tyrosine kinase inhibitor
(pan-TKI) that has previously been developed through Phase 3 in
renal cancer; and IXEMPRA® (Ixabepilone), a microtubule
inhibitor approved in the U.S. and marketed by R-PHARM U.S. for the
treatment of second-line metastatic breast cancer, currently in
Phase 2 development in Europe for the same indication.
Additionally, the Company has rights in two secondary assets:
2X-111, a liposomal formulation of doxorubicin for metastatic
breast cancer and/or glioblastoma multiforme (GBM), which is the
subject of discussions for a restructured out-license to Smerud
Medical Research International AS; and LiPlaCis®, a liposomal
formulation of cisplatin and its accompanying DRP®, being developed
via a partnership with CHOSA Oncology AB for late-stage metastatic
breast cancer. The Company is headquartered in the United States
and maintains an R&D facility in Hoersholm, Denmark. For more
information, please visit the Company’s website
at www.Allarity.com.
About the Drug Response Predictor –
DRP® Companion
Diagnostic Allarity uses its drug-specific
DRP® to select those patients who, by the genetic
signature of their cancer, are found to have a high likelihood of
responding to the specific drug. By screening patients before
treatment, and only treating those patients with a sufficiently
high, drug-specific DRP® score, the therapeutic
response rate can be significantly increased. The
DRP® method builds on the comparison of sensitive
vs. resistant human cancer cell lines, including transcriptomic
information from cell lines combined with clinical tumor biology
filters and prior clinical trial outcomes. DRP® is
based on messenger RNA from patient biopsies. The
DRP® platform has proven its ability to provide a
statistically significant prediction of the clinical outcome from
drug treatment in cancer patients in 37 out of 47 clinical studies
that were examined (both retrospective and prospective), including
ongoing, prospective Phase 2 trials of Stenoparib and IXEMPRA®. The
DRP® platform, which can be used in all cancer
types and is patented for more than 70 anti-cancer drugs, has been
extensively published in peer-reviewed literature.
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Forward-Looking Statements This press
release contains “forward-looking statements” within the meaning of
the Private Securities Litigation Reform Act of 1995.
Forward-looking statements provide Allarity’s current expectations
or forecasts of future events. The words “anticipates,” “believe,”
“continue,” “could,” “estimate,” “expect,” “intends,” “may,”
“might,” “plan,” “possible,” “potential,” “predicts,” “project,”
“should,” “would” and similar expressions may identify
forward-looking statements, but the absence of these words does not
mean that a statement is not forward-looking. These forward-looking
statements include, but are not limited to, statements related to
the expected availability of capital to fund its anticipated
clinical trials, statements related to advancing dovitinib in
combination with stenoparib or another therapeutic candidate or
other approved drug, any statements related to ongoing clinical
trials for stenoparib as a monotherapy or in combination with
another therapeutic candidate for the treatment of advanced ovarian
cancer, or ongoing clinical trials (in Europe) for
IXEMPRA® for the treatment of metastatic breast cancer,
statements relating to the effectiveness of the Company’s
DRP® companion diagnostics platform in predicting whether a
particular patient is likely to respond to a specific drug, and
statements related to the Company’s ability to regain compliance
with the Nasdaq Listing Rule. Any forward-looking statements in
this press release are based on management’s current expectations
of future events and are subject to multiple risks and
uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include,
but are not limited to, the risk that the Company is not able to
raise sufficient capital to support its current and anticipated
clinical trials, the risk that early results of a clinical
study do not necessarily predict final results and that one or more
of the clinical outcomes may materially change following more
comprehensive reviews of the data, and as more patient data become
available, the risk that results of a clinical study are subject to
interpretation and additional analyses may be needed and/or may
contradict such results, the receipt of regulatory approval for
stenoparib, dovitinib or any of our other therapeutic
candidates and companion diagnostics or, if approved, the
successful commercialization of such products, the risk of
cessation or delay of any of the ongoing or planned clinical trials
and/or our development of our product candidates, the risk that the
results of previously conducted studies will not be repeated or
observed in ongoing or future studies involving our therapeutic
candidates, and the risk that the current COVID-19 pandemic will
impact the Company’s current and future clinical trials and the
timing of the Company’s preclinical studies and other operations.
For a discussion of other risks and uncertainties, and other
important factors, any of which could cause our actual results to
differ from those contained in the forward-looking statements, see
the section entitled “Risk Factors” in our Form S-1 registration
statement filed on October 30, 2023, as amended and our Form 10-K
annual report on file with the Securities and Exchange
Commission, available at the Securities and Exchange Commission’s
website at www.sec.gov, and as well as discussions of
potential risks, uncertainties and other important factors in the
Company’s subsequent filings with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and the Company undertakes no duty to update this
information unless required by law.
###
Company Contact:
investorrelations@allarity.com
U.S. Media
Contact: Mike
Beyer Sam Brown,
Inc. +1 (312)
961-2502
mikebeyer@sambrown.com EU
Media
Contact: Thomas
Pedersen Carrotize
PR &
Communications +45
6062 9390 tsp@carrotize.com
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