- Phase 2 Trial of Stenoparib Concluded Early due
to Clear Clinical Benefits Achieved
- On Track to Regain Compliance with All Nasdaq
Listing Requirements
- No Variable Priced Securities are
Outstanding
- Warrant Overhang Near Elimination
- Allarity Withdraws its Form S-1
- Establishes Equity of $15 Million
- Cash Balance of $14 Million
Boston (May 14, 2024)—Allarity Therapeutics,
Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2
clinical-stage pharmaceutical company dedicated to developing
personalized cancer treatments, today reported financial results
and provided an update on recent operational highlights for the
first quarter that ended March 31, 2024.
"The start of 2024 has been a pivotal period for Allarity
Therapeutics, marked by significant achievements across financial,
regulatory, and clinical areas," remarked Thomas Jensen, CEO of
Allarity Therapeutics. "Our trials of stenoparib in advanced,
recurrent ovarian cancer have yielded encouraging proof of concept
data, which further boosted our optimism for the future of this
novel PARP inhibitor. Additionally, we've seen several developments
that we believe may strengthen our investment case. Our capital
structure has been simplified, and we have raised new equity, so we
are now on track to fully comply with Nasdaq's listing requirements
and find ourselves in a better position to steer clear of less
favorable future financing arrangements. Reflecting this new
strengthened financial position, we have requested the SEC to
withdraw our Form S-1 filed last October. With a strategic focus
now solely on stenoparib, we can use all our managerial resources
to advance this promising asset toward regulatory approval."
First Quarter 2024 and Recent Operational
Highlights
- Allarity Therapeutics now has a single class of shares after
investor-initiated conversions of all outstanding Series A
Preferred Stock and the majority of warrants into common stock.
Significantly, all variable-priced warrants have been exercised,
reducing market overhang from warrants. A limited number of
fixed-price warrants remain unexercised, each with an exercise
price of $20. Additionally, the Company has fully repaid all bridge
notes. These developments simplify Allarity's capital structure,
enhancing the attractiveness of its stock. As of today, the total
number of shares is 17,606,739.
- Allarity has requested the SEC to withdraw its Form S-1
registration, reflecting its improved financial outlook.
- Stockholders' equity at Allarity significantly exceeds the $2.5
million minimum required by Nasdaq under Listing Rule 5550(b)(1)
due to the fact that the Company has a cash balance of $14 million,
reduced its debts and increased its equity to $15 million utilizing
an "At-The-Market” (ATM) offering under a Form S-3. This method was
the most rapid and cost-effective way to raise capital before the
May 14, 2024, deadline set by Nasdaq. Formal confirmation by Nasdaq
of regaining compliance with Rule 5550(b)(1) is being sought.
- The Company has concluded its Phase 2 clinical trial of
stenoparib early due to clear clinical benefits observed, including
tumor shrinkage and long-term disease stability, in heavily
pre-treated ovarian cancer patients. Using Allarity’s DRP®
companion diagnostic to pre-screen patients, the trial targeted
those most likely to benefit. The promising results have provided
sufficient proof of concept, prompting Allarity to halt enrollment
with the purpose of preparing a follow-on trial with FDA regulatory
intent. The company plans to outline further details in a clinical
update.
- Allarity has regained compliance with Nasdaq’s Listing Rule
5550(a)(2), which mandates a minimum bid price of $1.00, after
executing a reverse stock split on April 9, 2024. Following the
split, the company's stock maintained a closing bid price above
$1.00 for more than ten consecutive trading days, leading to a
confirmation from Nasdaq of compliance.
- Driven by promising Phase 2 trial data, Allarity has
strategically shifted its focus solely to accelerating the
development of stenoparib for targeting advanced, recurrent ovarian
cancer. This shift has allowed significant reductions in ongoing
costs and better alignment with new strategic priorities while
deprioritizing other projects like the development of IXEMPRA® and
dovitinib.
- Allarity received an extension until April 24, 2024, from the
Nasdaq Hearings Panel to meet listing requirements, including
maintaining a minimum $1.00 share price and increasing
stockholders' equity to $2.5 million. The extension was granted
following the Company's presentation of a comprehensive plan to
regain compliance.
- CEO Thomas Jensen presented Allarity Therapeutics’ development
of the DRP® platform for personalized cancer therapy at the
Biomarkers 2024 conference, focusing on its use in a phase 2 study
of stenoparib for ovarian cancer. The presentation took place on
February 29, 2024, in London, UK.
First Quarter 2024 Operating Results
R&D Expenses: Research and Development
(R&D) expenses for the quarter ended March 31, 2024, were
$2.2 million, compared to $1.4 million for the quarter ended March
31, 2023. R&D costs were approximately $743 thousand higher in
2024 than in 2023, primarily because of increased manufacturing
costs of $524 thousand and because of an extension fee payment of
$150 thousand we paid to Eisai Co., Ltd. for our license agreement
on stenoparib.
G&A Expenses: General and Administrative
(G&A) expenses for the quarter ended March 31, 2024, were
$2.1 million, compared to $2.2 million for the quarter ended March
31, 2023. This decrease in G&A expenses was primarily due to
reduced insurance and professional fee expenses.
Net Loss from Operations: Net Loss from
Operations for the quarter ended March 31, 2024, was $4.2 million,
compared to $3.7 million for the quarter ended March 31, 2023.
Net Loss: Net loss was $3.8 million for the
quarter ended March 31, 2024, compared to $3.4 million for the
quarter ended March 31, 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 registration statement filed on April 17,
2024, 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.CONDENSED CONSOLIDATED BALANCE
SHEETS(U.S. dollars in thousands, except for share
and per share data)
|
|
|
March 31, |
|
|
December 31, |
|
|
|
|
2024 |
|
|
2023 |
|
|
|
|
(Unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash |
|
$ |
312 |
|
|
$ |
166 |
|
|
Other current assets |
|
|
110 |
|
|
|
209 |
|
|
Prepaid expenses |
|
|
542 |
|
|
|
781 |
|
|
Tax credit receivable |
|
|
1,331 |
|
|
|
815 |
|
|
Total current assets |
|
|
2,295 |
|
|
|
1,971 |
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
18 |
|
|
|
20 |
|
|
Intangible assets |
|
|
9,656 |
|
|
|
9,871 |
|
|
Total assets |
|
$ |
11,969 |
|
|
$ |
11,862 |
|
|
LIABILITIES AND STOCKHOLDERS’ (DEFICIT)
EQUITY |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
11,058 |
|
|
$ |
8,416 |
|
|
Accrued liabilities |
|
|
1,553 |
|
|
|
1,309 |
|
|
Warrant derivative liability |
|
|
2,664 |
|
|
|
3,083 |
|
|
Income taxes payable |
|
|
43 |
|
|
|
59 |
|
|
Convertible promissory notes and accrued interest, net of debt
discount |
|
|
2,690 |
|
|
|
1,300 |
|
|
Total current liabilities |
|
|
18,008 |
|
|
|
14,167 |
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
|
Deferred tax |
|
|
432 |
|
|
|
446 |
|
|
Total liabilities |
|
|
18,440 |
|
|
|
14,613 |
|
|
Commitments and contingencies (Note 16) |
|
|
|
|
|
|
|
|
|
Stockholders’ (deficit) equity |
|
|
|
|
|
|
|
|
|
Series A Preferred stock $0.0001 par value (20,000 shares
designated) shares issued and outstanding at March 31, 2024 and
December 31, 2023 were 1,215 and 1,417, respectively (liquidation
preference of $4.36 at March 31, 2024) |
|
|
1,510 |
|
|
|
1,742 |
|
|
Common stock, $0.0001 par value (750,000,000 shares authorized, at
March 31, 2024 and December 31, 2023); shares issued and
outstanding at March 31, 2024 and December 31, 2023 were
342,774 and 294,347, respectively |
|
|
— |
|
|
|
— |
|
|
Additional paid-in capital |
|
|
90,699 |
|
|
|
90,369 |
|
|
Accumulated other comprehensive loss |
|
|
(386 |
) |
|
|
(411 |
) |
|
Accumulated deficit |
|
|
(98,294 |
) |
|
|
(94,451 |
) |
|
Total stockholders’ deficit |
|
|
(6,471 |
) |
|
|
(2,751 |
) |
|
Total liabilities, preferred stock and stockholders’
(deficit) equity |
|
$ |
11,969 |
|
|
$ |
11,862 |
|
| |
All common share data has been retroactively adjusted to effect the
reverse stock split 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 endedMarch 31, |
|
|
|
|
2024 |
|
|
2023 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
$ |
2,170 |
|
|
$ |
1,427 |
|
|
General and administrative |
|
|
2,070 |
|
|
|
2,241 |
|
|
Total operating expenses |
|
|
4,240 |
|
|
|
3,668 |
|
|
Loss from operations |
|
|
(4,240 |
) |
|
|
(3,668 |
) |
|
Other income (expenses) |
|
|
|
|
|
|
|
|
|
Interest income |
|
|
— |
|
|
|
4 |
|
|
Interest expense |
|
|
(102 |
) |
|
|
(92 |
) |
|
Foreign exchange gains |
|
|
76 |
|
|
|
95 |
|
|
Change in fair value adjustment of derivative and warrant
liabilities |
|
|
419 |
|
|
|
309 |
|
|
Net other income |
|
|
393 |
|
|
|
316 |
|
|
Net loss for the period before tax benefit |
|
|
(3,847 |
) |
|
|
(3,352 |
) |
|
Income tax benefit |
|
|
4 |
|
|
|
— |
|
|
Net loss |
|
|
(3,843 |
) |
|
|
(3,352 |
) |
|
Deemed dividend of 5% on Series C Convertible Preferred stock |
|
|
— |
|
|
|
(4 |
) |
|
Gain on extinguishment of Series A Convertible Preferred stock |
|
|
191 |
|
|
|
— |
|
|
Deemed dividend on Series A Convertible Preferred stock |
|
|
(228 |
) |
|
|
— |
|
|
Net loss attributable to common stockholders |
|
$ |
(3,880 |
) |
|
$ |
(3,356 |
) |
|
Basic and diluted net loss per common stock |
|
$ |
(22.14 |
) |
|
$ |
(6,356.06 |
) |
|
Weighted-average number of common stock outstanding, basic
and diluted |
|
|
175,266 |
|
|
|
528 |
|
|
Other comprehensive loss, net of tax: |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,843 |
) |
|
$ |
(3,352 |
) |
|
Change in cumulative translation adjustment |
|
|
25 |
|
|
|
84 |
|
|
Total comprehensive loss attributable to common
stockholders |
|
$ |
(3,818 |
) |
|
$ |
(3,268 |
) |
| |
All common share data has been retroactively adjusted to effect the
reverse stock split in 2024. |
###
Company Contact:
investorrelations@allarity.com
Media
Contact: Thomas
Pedersen Carrotize
PR &
Communications +45
6062
9390 tsp@carrotize.com
- Allarity Therapeutics Press Release - Allarity Therapeutics
Reports First Quarter Financial Results
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