- Current
Cash Balance of $20 million Expected to Provide Runway Into
2026
- Allarity
to Pause Use of ATM
- Cap
Table Successfully Cleaned Up
-
Allarity’s Stenoparib Shows Extended Duration of Phase 2 Clinical
Benefit
Boston (July 22, 2024)—Allarity Therapeutics,
Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2
clinical-stage pharmaceutical company dedicated to developing
personalized cancer treatments, today outlines the Company’s
progress in 2024 and future objectives.
Led by New Management Allarity has Materially
Strengthened its Finances
The Company’s overall financial situation significantly improved
as the Company today announced a new, strong cash balance and
pausing of At-The-Market (ATM) offering:
- New Strong Cash Balance: Allarity Therapeutics
is pleased to announce that the Company now has a financial runway
extending into 2026 at its current burn rate with a cash balance of
$20M as of July 19, 2024.
- Pausing the ATM: In line with this newly
achieved financial position, Allarity plans to pause its ATM
offering program for the foreseeable future.
This new financial situation led by a new management that,
throughout 2024, has implemented several key actions to improve
Allarity’s future outlook:
- Cleaning Up the Capitalization Table:
Consolidated to a single class of common stock, eliminating
variable-priced convertible securities, including both warrants and
Series A Preferred Stock.
- Streamlining Operations and Cutting Costs:
Enhancing operational efficiency and reducing the cost base.
- Focusing Resources on Stenoparib:
Concentrating all company efforts on advancing stenoparib, a novel
dual PARP and Tankyrase inhibitor, the Company’s promising clinical
asset.
Stenoparib Continues To Show Extended Duration of
Clinical Benefit in Phase 2 Trial
Earlier this year, Allarity Therapeutics made a strategic pivot
away from a multi-asset pipeline strategy to accelerate and focus
solely on stenoparib.
As previously announced, in its Phase 2 clinical trial in
advanced, recurrent ovarian cancer patients, stenoparib continues
to show durable clinical benefit when given twice daily as
monotherapy, with multiple patients remaining on treatment more
than 30 weeks.
These results provided clinical proof of concept for stenoparib,
prompting Allarity to focus its resources on developing a follow-on
clinical trial to accelerate potential regulatory approval by the
FDA of stenoparib.
Company Receives Wells Notice
As Allarity disclosed today in a Form 8-K filing, on July 18,
2024, Allarity received a “Wells Notice” from the Staff of the
Securities and Exchange Commission (the “SEC”), relating to the
previously disclosed SEC investigation. The Wells Notice relates to
the Company’s disclosures regarding meetings with the United States
Food and Drug Administration (the “FDA”) regarding our NDA for
Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021.
Allarity also understands that three of its former officers
received Wells Notices from the SEC relating to the same
conduct.
The Company understands that all of the conduct relating to the
SEC Staff’s Wells Notice occurred during or prior to fiscal year
2022. A Wells Notice is neither a formal charge of wrongdoing nor a
final determination that the recipient has violated any law. The
Wells Notice informed the Company that the SEC Staff has made a
preliminary determination to recommend that the SEC file an
enforcement action against the Company that would allege certain
violations of the federal securities laws. The Company is
continuing to cooperate with the SEC and maintains that its actions
were appropriate and intends to pursue the Wells Notice process,
including submitting a formal response to the SEC.
Proposed Reverse Stock Split Necessary to Maintain
NASDAQ Listing
The Company’s board of directors has put a proposal before
shareholders for a reverse stock split. Allarity has requested
approval of the reverse stock split to regain and sustain
compliance with NASDAQ requirements. The reverse split is essential
to enabling compliance with this objective. If the Reverse Stock
Split is not approved by the Company’s stockholders, the Company’s
common stock may be delisted from NASDAQ. Maintaining a NASDAQ
listing is crucial for investor confidence and to maintain
liquidity in the Company’s common stock. Put simply, a NASDAQ
delisting could complicate stockholder’s ability to trade the
Company’s common stock, impact its stock price and affect
stockholder’s ability to buy or sell when desired. Failure to
secure approval for the reverse stock split may hinder management’s
ability to execute its strategy, to the detriment of shareholders.
Additionally, it may impede strategic initiatives dependent on the
issuance of common stock. It is essential to understand that a
reverse stock split consolidates existing shares, preserving the
Company’s overall value and each shareholder’s respective ownership
percentage.
We respectfully request that you vote in favor of the
reverse split proposal. If you have already
voted, it is not too late to change your vote should you wish to do
so. If you have any questions or need help voting, please call
Allarity’s proxy solicitor, Sodali & Co, at +1 212 300
2470.
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 clinical and operational
achievements on future trial designs and regulatory progress,
potential commercial partnerships, planning and execution of
registrational intent clinical trials, the anticipated progress of
stenoparib following its Phase 2 clinical trial, the potential
outcomes of ongoing SEC investigations, the proposal and potential
approval of a reverse stock split, and the possibility of Nasdaq
listing compliance issues or changes. 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, the
trading price of Allarity’s shares of common stock may be volatile
and other risks inherent in Allarity’s business including, 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, and 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 possible impact of SEC investigations and Wells
Notices, and the possibility of Nasdaq delisting. 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.
###
Company Contact:
investorrelations@allarity.com
Media
Contact: Thomas
Pedersen Carrotize
PR &
Communications +45
6062 9390 tsp@carrotize.com
- Allarity Therapeutics Press Release - Allarity Outlines
Company's 2024 Progress and Objectives
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