-
Leadership Changes Led by Appointment of Co-Founder Thomas Jensen
as Interim CEO and Jeremy Graff, Ph.D., former Eli Lilly Executive,
as Executive Advisor
-
Reduced Net Loss from Operations by 50% and Reduced Net Loss by
26%
-
Announced Data in December 2023 from Advanced Ovarian Cancer Phase
2 Stenoparib Study Showing Significant Clinical Benefit
Boston (March 8, 2024) — Allarity Therapeutics,
Inc. (“Company”) (NASDAQ: ALLR), a clinical-stage pharmaceutical
company dedicated to developing personalized cancer treatments,
today reported financial results for the year ended December 31,
2023, and provided a general business update.
The Company's Interim Chief Executive Officer, Thomas Jensen,
stated, “2023 was a year of remarkable achievements for Allarity
Therapeutics as we made significant strides in advancing our
DRP®-guided drug development. Our clinical research has shown
strong indications that we can address a significant unmet medical
need in oncology. In particular, our lead asset, stenoparib, has
demonstrated exceptional promise in advanced ovarian cancer trials.
As we continue through 2024, our focus remains on continuing to
generate and report on additional pivotal clinical trial data for
stenoparib, which we expect will further strengthen interest in our
work from a broad group of stakeholders, including leading
oncologists, potential partner companies, and the biotech investor
community."
2023 Highlights and Recent
Developments
Stenoparib (2X-121): An orally available, small
molecule dual-targeted inhibitor of poly-ADP ribose polymerase
(PARP1/2) and telomerase maintenance enzymes (Tankyrase 1 and
2) in development for advanced ovarian cancer.
- Early data announced in December
2023 from the Phase 2 monotherapy study of stenoparib for advanced
ovarian cancer showed significant clinical benefit in evaluable
patients following a protocol change to twice-daily dosing earlier
in the year. Using the DRP®-Stenoparib companion diagnostic (CDx),
which includes 414 mRNA biomarkers, patients were selected based on
a DRP score above 50%. Of 22 screened, 17 were DRP positive, with
11 treated, of which five were evaluable before the data evaluation
cut-off. One trial participant showed a complete response in
December 2023, and the other four evaluable patients had stable
diseases, all were previously treated with PARP inhibitors and
chemotherapy.
Announced leadership changes and strategic advisory
engagement:
- Appointment of co-founder Thomas H.
Jensen as Interim Chief Executive Officer in December 2023. With
nearly two decades at Allarity Therapeutics, Jensen brings
extensive experience and a deep understanding of the company’s DRP®
to his new role. Mr. Jensen has been instrumental in developing
molecular biological techniques essential for the DRP platform and
played a key role in building investor relations and securing
financing.
- Engaged Jeremy R. Graff, Ph.D., as
an Executive Advisor. Dr. Graff, with over 25 years of experience
in biotech and pharma, is a specialist in both developing clinical
strategy and successful execution of numerous clinical development
programs of cancer therapeutics. His notable career includes
C-level positions and a significant tenure at Eli Lilly, where he
led the translational oncology group.
Anticipated Clinical Milestones in
2024
The focus of the Company remains on generating and disclosing
pivotal clinical data to demonstrate the clinical benefit of our
DRP guided therapies. Accordingly, we expect to announce interim
data from the DRP®-guided Phase 2 clinical trial of stenoparib in
advanced ovarian cancer during the second quarter of 2024. We
believe that this milestone is particularly significant as it will
provide further insights into stenoparib's potential to meet the
unmet needs in the treatment of advanced ovarian cancer.
Full Year 2023 Operating
Results
R&D Expenses: Research and Development
(R&D) expenses were $7.1 million for 2023, compared to $6.9
million for 2022.
G&A Expenses: General and Administrative
(G&A) expenses were $10.0 million for 2023, compared to $10.0
million for 2022.
Net Loss from Operations: Net Loss from
Operations was $17.1 million for 2023, compared to $34 million for
2022.
Net Loss: Net loss was $11.9 million for 2023,
compared to $16.1 million for 2022.
About the Drug Response Predictor – DRP® Companion
Diagnostic Allarity uses its drug-specific DRP® to select
those patients who, by the expression signature of their cancer,
are found to have a high likelihood of benefiting from a specific
drug. By screening patients before treatment, and only treating
those patients with a sufficiently high, drug-specific DRP score,
the therapeutic benefit rate may 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 expression
profiles 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). 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 the peer-reviewed literature.
About Allarity TherapeuticsAllarity
Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage
biopharmaceutical company dedicated to developing personalized
cancer treatments. The Company is focused on development of
stenoparib, a novel PARP/Tankyrase inhibitor for advanced ovarian
cancer patients, using its DRP® companion diagnostic for patient
selection in the ongoing phase 2 clinical trial, NCT03878849.
Allarity is headquartered in the U.S., with a research facility in
Denmark, and is committed to addressing significant unmet medical
needs in cancer treatment. For more information, visit
www.allarity.com.
Follow Allarity on Social MediaLinkedIn:
https://www.linkedin.com/company/allaritytx/X:
https://twitter.com/allaritytx
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 the Company’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 release of the clinical
trial data in 2024 and its impact on strengthening interest in our
work, the availability of interim/final data readout from the DRP
guided Phase 2 clinical trial of stenoparib for advanced ovarian
cancer, the possibility of a financing in Q1 2024 and expected
availability of capital to fund its anticipated clinical trials,
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 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 (the “SEC”), available at the
SEC’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 SEC. 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.
ALLARITY THERAPEUTICS,
INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSSFor the years ended December 31,
2023 and 2022(U.S. dollars in thousands, except
for share and per share data)
|
|
|
2023 |
|
|
2022 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
$ |
7,103 |
|
|
$ |
6,930 |
|
|
Impairment of intangible assets |
|
|
— |
|
|
|
17,571 |
|
|
General and administrative |
|
|
10,026 |
|
|
|
9,962 |
|
|
Total operating expenses |
|
|
17,129 |
|
|
|
34,463 |
|
|
Loss from operations |
|
|
(17,129 |
) |
|
|
(34,463 |
) |
|
Other income (expenses) |
|
|
|
|
|
|
|
|
|
Income from the sale of IP |
|
|
— |
|
|
|
1,780 |
|
|
Interest income |
|
|
22 |
|
|
|
30 |
|
|
Interest expenses |
|
|
(498 |
) |
|
|
(223 |
) |
|
Loss on investment |
|
|
— |
|
|
|
(115 |
) |
|
Foreign exchange gains (losses) |
|
|
133 |
|
|
|
(913 |
) |
|
Fair value of inducement warrants |
|
|
(4,189 |
) |
|
|
— |
|
|
Loss on modification of warrants |
|
|
(591 |
) |
|
|
— |
|
|
Change in fair value adjustment of warrant derivative
liabilities |
|
|
10,434 |
|
|
|
17,125 |
|
|
Penalty on Series A Preferred stock liability |
|
|
— |
|
|
|
(800 |
) |
|
Net other income, net |
|
|
5,311 |
|
|
|
16,884 |
|
|
Net loss before tax recovery (expense) |
|
|
(11,818 |
) |
|
|
(17,579 |
) |
|
Deferred income tax (expense) benefit |
|
|
(83 |
) |
|
|
1,521 |
|
|
Net loss |
|
|
(11,901 |
) |
|
|
(16,058 |
) |
|
Cash payable on converted Series A Preferred Stock |
|
|
— |
|
|
|
(3,421 |
) |
|
Deemed dividends on Series A Preferred Stock |
|
|
(8,392 |
) |
|
|
— |
|
|
Deemed dividend of on Series C Preferred Stock |
|
|
(123 |
) |
|
|
(1,572 |
) |
|
Net loss attributable to common stockholders |
|
$ |
(20,416 |
) |
|
$ |
(21,051 |
) |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common stock |
|
$ |
(10.26 |
) |
|
$ |
(3,093.42 |
) |
|
Weighted average number of common stock outstanding, basic
and diluted |
|
|
1,990,748 |
|
|
|
6,805 |
|
|
Other comprehensive loss, net of tax: |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(11,901 |
) |
|
$ |
(16,058 |
) |
|
Change in cumulative translation adjustment |
|
|
310 |
|
|
|
(121 |
) |
|
Comprehensive loss attributable to common
stockholders |
|
$ |
(11,591 |
) |
|
$ |
(16,179 |
) |
| |
All common share data has been retroactively adjusted to effect
reverse stock splits in 2023. |
ALLARITY THERAPEUTICS,
INC.CONSOLIDATED BALANCE SHEETSAs
of December 31, 2023 and 2022(U.S. dollars in
thousands, except for share and per share data)
|
|
|
December 31, |
|
|
December 31, |
|
|
|
|
2023 |
|
|
2022 |
|
|
ASSETS |
|
|
|
|
|
|
| Current
assets: |
|
|
|
|
|
|
|
Cash |
|
$ |
166 |
|
|
$ |
2,029 |
|
|
Other current assets |
|
|
209 |
|
|
|
1,559 |
|
|
Prepaid expenses |
|
|
781 |
|
|
|
591 |
|
|
Tax credit receivable |
|
|
815 |
|
|
|
789 |
|
|
Total current assets |
|
|
1,971 |
|
|
|
4,968 |
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
20 |
|
|
|
21 |
|
|
Operating lease right of use assets |
|
|
— |
|
|
|
6 |
|
|
Intangible assets |
|
|
9,871 |
|
|
|
9,549 |
|
|
Total assets |
|
$ |
11,862 |
|
|
$ |
14,544 |
|
|
LIABILITIES AND STOCKHOLDERS’ (DEFICIT)
EQUITY |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
8,416 |
|
|
$ |
6,251 |
|
|
Accrued liabilities |
|
|
1,309 |
|
|
|
1,904 |
|
|
Warrant derivative liability |
|
|
3,083 |
|
|
|
374 |
|
|
Income taxes payable |
|
|
59 |
|
|
|
41 |
|
|
Convertible promissory note and accrued interest, net of debt
discount |
|
|
1,300 |
|
|
|
— |
|
|
Secured promissory notes |
|
|
— |
|
|
|
2,644 |
|
|
Operating lease liabilities, current |
|
|
— |
|
|
|
8 |
|
|
Total current liabilities |
|
|
14,167 |
|
|
|
11,222 |
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
|
Convertible promissory note and accrued interest, net of debt
discount |
|
|
— |
|
|
|
1,083 |
|
|
Deferred tax |
|
|
446 |
|
|
|
349 |
|
|
Total liabilities |
|
|
14,613 |
|
|
|
12,654 |
|
|
Redeemable preferred stock (500,000 shares
authorized) |
|
|
|
|
|
|
|
|
|
Series A Preferred Stock $0.0001 par value (20,000 shares
designated) shares issued and outstanding at December 31, 2023 and
2022, were 1,417 and 13,586, respectively (liquidation preference
of $17.54 at December 31, 2023) |
|
|
— |
|
|
|
2,001 |
|
|
Series B Preferred Stock $0.0001 par value (200,000 shares
designated); shares issued at December 31, 2023 and 2022, were
0 and 190,786, respectively (liquidation preference of $0 at
December 31, 2023) |
|
|
— |
|
|
|
2 |
|
|
Series C Convertible Preferred stock $0.0001 par value (50,000 and
0 shares designated at December 31, 2023 and 2022,
respectively); shares issued and outstanding at December 31,
2023 were 0 |
|
|
— |
|
|
|
— |
|
|
Total redeemable preferred stock |
|
|
— |
|
|
|
2,003 |
|
|
Stockholders’ (deficit) equity |
|
|
|
|
|
|
|
|
|
Series A Preferred stock $0.0001 par value (20,000 shares
designated) shares issued and outstanding at December 31, 2023 and
2022, were 1,417 and 13,586, respectively (liquidation preference
of $17.54 at December 31, 2023) |
|
|
1,742 |
|
|
|
— |
|
|
Common Stock, $0.0001 par value (750,000,000 and 30,000,000 shares
authorized, at December 31, 2023 and 2022, respectively);
shares issued and outstanding at December 31, 2023 and 2022,
were 5,886,934 and 11,356, respectively |
|
|
— |
|
|
|
— |
|
|
Additional paid-in capital |
|
|
90,369 |
|
|
|
83,158 |
|
|
Accumulated other comprehensive loss |
|
|
(411 |
) |
|
|
(721 |
) |
|
Accumulated deficit |
|
|
(94,451 |
) |
|
|
(82,550 |
) |
|
Total stockholders’ deficit |
|
|
(2,751 |
) |
|
|
(113 |
) |
|
Total liabilities, preferred stock and stockholders’
(deficit) equity |
|
$ |
11,862 |
|
|
$ |
14,544 |
|
| |
All common share data has been retroactively adjusted to effect
reverse stock splits in 2023. |
###
Company Contact:
investorrelations@allarity.com
Media Contact: Thomas
Pedersen Carrotize
PR & Communications +45 6062
9390 tsp@carrotize.com
- Allarity Press Release - Full Year 2023 Financial Results and
Business Update
Allarity Therapeutics (NASDAQ:ALLR)
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