Allarity Therapeutics Reports Third Quarter 2024 Financial Results and Provides Recent Operational Highlights
14 Novembre 2024 - 2:00PM
- Cash
balance at $18.5 million
-
Strengthened leadership team with new members driving stenoparib
development
- NASDAQ
compliance regained
Boston (November 14, 2024)—Allarity
Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a
Phase 2 clinical-stage pharmaceutical company dedicated to
developing personalized cancer treatments using its proprietary,
drug-specific patient selection technology, today reported
financial results for the third quarter ended September 30, 2024,
and provided an update on recent operational highlights.
“This quarter’s progress marks a steady period of advancement
for Allarity as we have maintained a strong cash position, achieved
record patient duration on stenoparib treatment, and welcomed new
members to our leadership team who bring the expertise needed to
shape a successful future for the Company," said Thomas Jensen, CEO
of Allarity Therapeutics. "We continue to drive the development of
our promising, novel dual PARP/tankyrase inhibitor, stenoparib,
forward, and we remain optimistic that our efforts will ultimately
bring new hope to ovarian cancer patients, especially those who
currently have few or no treatment options.”
Third Quarter 2024 and Recent Operational
Highlights
- Encouraging Patient Outcomes in Phase 2 Stenoparib
Trial: On September 16, 2024, the Company announced that
two patients in its Phase 2 trial for stenoparib in advanced
ovarian cancer had exceeded one year on treatment, demonstrating
durable clinical benefit in this heavily pre-treated population and
highlighting the potential of stenoparib as a meaningful treatment
option for patients with limited or no alternatives.
- New Leadership to Drive Clinical Development:
The Company, led by President and Chief Development Officer Jeremy
R. Graff, Ph.D., and Consultant Chief Medical Officer Jose
Iglesias, M.D., both appointed in October 2024, is working closely
with its scientific advisors to prepare a follow-on trial aimed at
FDA regulatory intent. Dr. Graff—a distinguished oncology expert
with over 25 years in drug development who previously served as a
consultant to Allarity—and Dr. Iglesias—a seasoned leader in
oncology clinical trials and former Celgene executive—bring
invaluable experience and strategic insight to advance Allarity’s
clinical trial efforts.
- Appointment of New CFO: In September 2024,
Allarity appointed Alexander Epshinsky as Chief Financial Officer.
With nearly a decade of financial leadership experience in the
biotech sector, Mr. Epshinsky brings valuable expertise to support
the Company’s financial strategy as it advances the development of
stenoparib.
- European Patent Secured for Stenoparib
DRP®: The Company was granted a European
patent in October 2024 for its proprietary DRP® companion
diagnostic specific to stenoparib, strengthening Allarity’s market
position by securing critical IP protection for this unique
diagnostic in an important market. Patent applications are also
pending in other key regions, including the U.S., Japan, and
China.
- Regained NASDAQ Compliance: In October 2024,
the Company received formal notice from The Nasdaq Stock Market LLC
confirming that it had regained compliance with the minimum bid
price requirement under Nasdaq Listing Rule 5550(a)(2) for
continued listing on the Nasdaq Capital Market, effectively
concluding the previously disclosed listing matter.
Third Quarter 2024 Financial
HighlightsCash Position: As of September
30, 2024, Allarity had cash and cash equivalents of $18.5 million,
compared to $0.2 million at December 31, 2023. The Company
maintains a financial runway extending into 2026.
R&D Expenses: Research and development
expenses for the third quarter of 2024 were $1.0 million, compared
to $1.9 million for the third quarter of 2023. Additionally, the
Company recorded a $9.7 million intangible asset impairment charge
(non-cash) for the third quarter of 2024.
G&A Expenses: General and administrative
expenses for the third quarter of 2024 were $1.6 million, compared
to $2.5 million for the third quarter of 2023.
Net Loss: Net loss attributable to common
stockholders for the third quarter of 2024 was $12.2 million
(primarily due to the aforementioned $9.7 million intangible asset
impairment charge), compared to a net loss of $5.6 million for the
third quarter of 2023.About the Drug Response Predictor –
DRP® Companion DiagnosticAllarity uses its drug-specific
DRP® to select those patients who, by the gene 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 dozens of clinical studies (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, the impact of recent financial and operational
achievements on future quarterly performance, potential future
financings, and the anticipated regulatory progress of stenoparib
following the final outcome of our Phase 2 clinical trial. 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 risks associated
with maintaining compliance with Nasdaq's continued listing
requirements, obtaining regulatory approval for stenoparib, and
potential market fluctuations that could impact our financial
stability and the drug's market entry. 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/A registration statement filed on April
17, 2024, our Form 10-K annual report on file with the Securities
and Exchange Commission (the “SEC”) and our Form 10-Q quarterly
report filed with the SEC on November 14, 2024, 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.CONDENSED CONSOLIDATED BALANCE
SHEETS(Unaudited)(U.S. dollars in
thousands, except for share and per share data)
| |
|
September 30, |
|
|
December 31, |
|
| |
|
2024 |
|
|
2023 |
|
|
ASSETS |
|
|
|
|
|
|
|
|
| Current assets |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
18,463 |
|
|
$ |
166 |
|
|
Other current assets |
|
|
100 |
|
|
|
209 |
|
|
Prepaid expenses |
|
|
151 |
|
|
|
781 |
|
|
Tax credit receivable |
|
|
1,652 |
|
|
|
815 |
|
|
Total current assets |
|
|
20,366 |
|
|
|
1,971 |
|
| |
|
|
|
|
|
|
|
|
| Property, plant and
equipment, net |
|
|
12 |
|
|
|
20 |
|
| Intangible
assets |
|
|
— |
|
|
|
9,871 |
|
| Total
assets |
|
$ |
20,378 |
|
|
$ |
11,862 |
|
| |
|
|
|
|
|
|
|
|
| LIABILITIES
AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
| Current
liabilities |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
4,693 |
|
|
$ |
8,416 |
|
|
Accrued liabilities |
|
|
1,322 |
|
|
|
1,309 |
|
|
Warrant derivative liability |
|
|
2 |
|
|
|
3,083 |
|
|
Income taxes payable |
|
|
60 |
|
|
|
59 |
|
|
Convertible promissory notes and accrued interest, net of debt
discount |
|
|
1,337 |
|
|
|
1,300 |
|
|
Total current liabilities |
|
|
7,414 |
|
|
|
14,167 |
|
| |
|
|
|
|
|
|
|
|
| Deferred tax |
|
|
— |
|
|
|
446 |
|
| Total
liabilities |
|
|
7,414 |
|
|
|
14,613 |
|
| |
|
|
|
|
|
|
|
|
| Commitments
and contingencies (Note 15) |
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
Stockholders’ equity (deficit) |
|
|
|
|
|
|
|
|
|
Series A Preferred stock $0.0001 par value (500,000 and 20,000
shares designated at September 30, 2024 and December 31, 2023,
respectively) shares issued and outstanding at September 30, 2024
and December 31, 2023 were 0 and 1,417, respectively |
|
|
— |
|
|
|
1,742 |
|
| Common stock,
$0.0001 par value (250,000,000 and 750,000,000 shares authorized,
at September 30, 2024 and December 31, 2023, respectively); shares
issued and outstanding at September 30, 2024 and December 31, 2023
were 2,759,070 and 9,812, respectively |
|
|
— |
|
|
|
— |
|
| Additional paid-in
capital |
|
|
125,170 |
|
|
|
90,369 |
|
| Accumulated other
comprehensive loss |
|
|
(693 |
) |
|
|
(411 |
) |
| Accumulated
deficit |
|
|
(111,513 |
) |
|
|
(94,451 |
) |
| Total stockholders’
equity (deficit) |
|
|
12,964 |
|
|
|
(2,751 |
) |
| Total
liabilities and stockholders’ equity |
|
$ |
20,378 |
|
|
$ |
11,862 |
|
| |
All common share data has been retroactively adjusted to effect the
reverse stock splits in 2024. |
ALLARITY
THERAPEUTICS, INC.CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS(Unaudited)(U.S. dollars in
thousands, except for share and per share data)
| |
|
Three Months Ended |
|
|
Nine Months Ended |
|
| |
|
September 30, |
|
|
September 30, |
|
| |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
| Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,021 |
|
|
$ |
1,948 |
|
|
$ |
4,249 |
|
|
$ |
4,480 |
|
|
Impairment of intangible assets |
|
|
9,703 |
|
|
|
— |
|
|
|
9,703 |
|
|
|
— |
|
|
General and administrative |
|
|
1,589 |
|
|
|
2,478 |
|
|
|
5,972 |
|
|
|
7,770 |
|
| Total operating
expenses |
|
|
12,313 |
|
|
|
4,426 |
|
|
|
19,924 |
|
|
|
12,250 |
|
| Loss from
operations |
|
|
(12,313 |
) |
|
|
(4,426 |
) |
|
|
(19,924 |
) |
|
|
(12,250 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Other income
(expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
261 |
|
|
|
12 |
|
|
|
314 |
|
|
|
19 |
|
|
Interest expense |
|
|
(50 |
) |
|
|
(34 |
) |
|
|
(578 |
) |
|
|
(268 |
) |
|
Foreign exchange (losses) gains |
|
|
121 |
|
|
|
(156 |
) |
|
|
69 |
|
|
|
(87 |
) |
|
Fair value of New September Warrants |
|
|
— |
|
|
|
(4,189 |
) |
|
|
— |
|
|
|
(4,189 |
) |
|
Fair value of modification to April & July 2023 Warrants |
|
|
— |
|
|
|
(591 |
) |
|
|
— |
|
|
|
(591 |
) |
|
Change in fair value of derivative and warrant liabilities |
|
|
14 |
|
|
|
4,937 |
|
|
|
2,676 |
|
|
|
7,187 |
|
| Total other income
(expense) |
|
|
346 |
|
|
|
(21 |
) |
|
|
2,481 |
|
|
|
2,071 |
|
| Net loss before tax
benefit |
|
|
(11,967 |
) |
|
|
(4,447 |
) |
|
|
(17,443 |
) |
|
|
(10,179 |
) |
| Income tax
benefit |
|
|
377 |
|
|
|
— |
|
|
|
381 |
|
|
|
— |
|
| Net
loss |
|
|
(11,590 |
) |
|
|
(4,447 |
) |
|
|
(17,062 |
) |
|
|
(10,179 |
) |
| Deemed dividend on
Series A Preferred Stock |
|
|
— |
|
|
|
(1,105 |
) |
|
|
(299 |
) |
|
|
(8,392 |
) |
| Deemed dividend on
Series A Convertible Preferred Stock |
|
|
(562 |
) |
|
|
— |
|
|
|
(562 |
) |
|
|
— |
|
| Gain on
extinguishment of Series A Convertible Preferred Stock |
|
|
— |
|
|
|
— |
|
|
|
222 |
|
|
|
— |
|
| Deemed dividend on
Series C Preferred Stock |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(123 |
) |
| Net loss
attributable to common stockholders |
|
$ |
(12,152 |
) |
|
$ |
(5,552 |
) |
|
$ |
(17,701 |
) |
|
$ |
(18,694 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Basic and diluted
net loss per common stock |
|
$ |
(7.71 |
) |
|
$ |
(1,346.09 |
) |
|
$ |
(25.33 |
) |
|
$ |
(11,630.75 |
) |
| Weighted-average
number of common stock outstanding, basic and diluted |
|
|
1,575,762 |
|
|
|
4,125 |
|
|
|
698,877 |
|
|
|
1,607 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Other comprehensive
loss, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(11,590 |
) |
|
$ |
(4,447 |
) |
|
$ |
(17,062 |
) |
|
$ |
(10,179 |
) |
|
Change in cumulative translation adjustment |
|
|
(163 |
) |
|
|
(92 |
) |
|
|
(282 |
) |
|
|
(37 |
) |
| Total comprehensive
loss attributable to common stockholders |
|
$ |
(11,753 |
) |
|
$ |
(4,539 |
) |
|
$ |
(17,344 |
) |
|
$ |
(10,216 |
) |
| |
All common share data has been retroactively adjusted to effect the
reverse stock splits in 2024. |
###
Company Contact:
investorrelations@allarity.com
Media
Contact: Thomas
Pedersen Carrotize
PR &
Communications +45
6062
9390 tsp@carrotize.com
- Allarity Therapeutics Q3 Report Press Release
Allarity Therapeutics (NASDAQ:ALLR)
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