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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
August 7, 2023
ALLARITY THERAPEUTICS, INC.
(Exact name of registrant as specified in our charter)
| Delaware |
|
001-41160 |
|
87-2147982 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
24 School Street, 2nd Floor
Boston, MA |
|
02108 |
| (Address of Principal Executive Offices) |
|
(Zip Code) |
(401) 426-4664
(Registrant’s telephone number, including
area code)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
| ☐ | Written communications pursuant
to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to
Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
| Common Stock, par value $0.0001 per share |
|
ALLR |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act.
Item 5.02 Departure of Directors or Certain Officers; Appointment
of Certain Officers; Compensatory Arrangements of Certain Officers.
(b) On August 7, 2023, the Board of Directors
(the “Board”) of Allarity Therapeutics, Inc. (the “Company”) received the resignation of Mr. Robert Oliver as
director of the Company, including his position on each Board committee on which he was appointed
to, effective immediately. Mr. Oliver’s resignation is for personal reasons and
not due to any disagreement with the Company’s management team or the Company’s Board on any matter relating to the operations,
policies or practices of the Company or any issues regarding the Company’s accounting policies or practices.
(d) To fill the vacancy on the Board committees
as a result of Mr. Oliver’s resignation, the Board appointed Dr. Laura Benjamin as a member of the Audit Committee and Compensation
Committee of the Board, effective as of August 7, 2023. Dr. Benjamin was previously appointed as an independent director and is also a
member of the Nominating and Governance Committee of the Board since August 1, 2023.
Item 7.01 Regulation FD Disclosure.
On August 11, 2023, the
Company issued a letter to its stockholders from the Company’s Chief Executive Officer, James G. Cullem. The letter is also posted
on the Company’s website. A copy of the letter is attached Exhibit 99.1 to this Current Report
on Form 8-K and is incorporated herein by reference.
The information reported
under Item 7.01 in this Current Report on Form 8-K, and Exhibit 99.1 attached hereto are being “furnished” and shall not be
deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise
subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of
1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing. This Current Report on Form 8-K
will not be deemed an admission as to the materiality of any information contained herein.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
| Exhibit |
|
Exhibit Description |
| 99.1 |
|
Letter to Stockholders |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
Allarity Therapeutics, Inc. |
| |
|
|
| |
By: |
/s/ James G. Cullem |
| |
|
James G. Cullem |
| |
|
Chief Executive Officer |
| |
|
|
| Dated: August 11, 2023 |
|
|
2
Exhibit 99.1
Allarity Therapeutics CEO Letter to Shareholders
BOSTON, August 11, 2023
Dear Allarity Therapeutics Shareholders:
As we recently marked the end of my first year as CEO, I wanted to
reflect on our collective journey, address concerns that have been raised, acknowledge challenges we have faced, and highlight the significant
progress we have towards “Realizing the Promise of Personalized Cancer Care.” As always, your continuing support of, and trust
in, our mission remain essential to our progress, and I am grateful for your steadfast dedication to Allarity Therapeutics.
First, from the time of our Nasdaq listing in late 2021 to the present
time, we acknowledge and are equally frustrated by the decline of our market capitalization. Our executive management and clinical teams
continue to firmly believe that Allarity’s current share price and market capitalization are truly not indicative of the underlying
value of our therapeutic programs, our DRP® platform technology, or our Company.
That being said, I am thrilled to acknowledge that we have succeeded,
despite an incredibly difficult life sciences capital market environment over the past 18 months, to raise capital needed to advance our
clinical programs towards anticipated interim data readouts for our two Phase 2 clinical trials (for stenoparib and IXEMPRA®) later
this year.
Since the start of 2023, Allarity Therapeutics has successfully raised
a total of $18.5 million of new investment capital. We have doggedly succeeded in these new capitalizations against the backdrop of a
capital market (for sub-$100M market capitalization public companies) that has seen an overall decline of 55% since January 2022 and during
which dozens of biotech companies in our sector have gone bankrupt, been dissolved, or substantially suspended operations and laid off
employees. Despite these very challenging headwinds, we have persisted in securing the necessary financing to advance our vision and the
potential of our innovative oncology therapeutics pipeline together with our core DRP® companion diagnostics platform.
I am extremely pleased with, and thankful for, the non-stop efforts
and commitment of our executive team, our employees, and our external team of advisors, legal counsel, and consultants for helping us
weather this continuing storm. But, the reality is that we cannot advance our clinical programs and enhance shareholder value without
accessing new capital to support our efforts. So, we must “continue the march” towards that goal.
Our success in raising new capital resulted, among other clinical program
progress, in the initiation of Allarity’s first combination therapy study, for stenoparib + dovitinib in a Phase 1b/2 clinical trial,
in early 2023. This milestone marks the first major event in the strategic refocus of our pipeline development activities announced in
August of last year.
Allarity
Therapeutics, Inc. I 24 School Street, 2nd Floor I Boston,
MA I U.S.A. I NASDAQ: ALLR I
www.allarity.com
Additionally, Allarity recently issued two press releases highlighting
positive clinical data from studies prospectively using our DRP® companion diagnostics (CDx) to improve cancer treatments.
| ● | In our ongoing IXEMPRA® Phase 2 trial in Europe, we announced very early data relating to the use of our DRP®-IXEMPRA®
CDx for patient selection and treatment. The data indicated promising, early signs of improved clinical benefit in metastatic breast cancer
(mBC), with notable data on tumor shrinkage and stable disease periods. |
| ● | Additionally, our concluded Phase 2 trial with one of Allarity’s prior programs, LiPlaCis® (a novel liposomal formulation
of the chemotherapeutic, cisplatin) in metastatic breast cancer patients (mBC) showcased the DRP®’s ability to identify mBC
patients that would likely benefit from this drug (which is now out-licensed). The encouraging results of this clinical study were selected
and accepted for abstract presentation at the 2023 ASCO Annual Meeting in Chicago and were published on June 3 of this year. |
These prospective trial data support what we have seen in many previous
retrospective studies: the significant potential for our DRP® CDx to improve cancer patient care by identifying those most likely
to respond to a given treatment. With these recent data, we remain highly optimistic about the progress of our ongoing clinical programs
and the advancement of our core DRP® platform. Our commitment to DRP® CDx is unwavering and with your ongoing trust and support,
we will continue to push through these challenging times to finance our clinical programs and succeed in Allarity’s vision to advance
personalized medicine for cancer patients.
I am further pleased to announce that our PARP inhibitor, stenoparib,
is now our lead clinical asset, and is currently being advanced in two out of three of our ongoing clinical trials. We will continue to
focus our energies, efforts, and resources on advancing clinical development of stenoparib, supported by continuing clinical development
of our IXEMPRA® and dovitinib assets, both of which we continue to believe have substantial clinical and commercial potential.
Most recently, we announced the expansion of our Board of Directors
with several new, highly-qualified and independent Directors, which completes a Board restructuring that we initiated shortly after Allarity
was listed on Nasdaq. Our Board is now the strongest and most qualified that it has ever been, and will provide us with the highest level
of corporate oversight and guidance.
On the heels of our Board expansion, we also recently announced a clinical
development collaboration with FivepHusion in which Allarity will support their clinical advancement of Deflexifol™ (a novel and
promising formulation of the widely used chemotherapeutic 5-fluorouracil (5FU)) with our validated 5FU-DRP® CDx, among others, to
select and treat cancer patients most likely to respond to Deflexifol™. This exciting clinical collaboration demonstrates our continued
commitment to “Realizing the Promise of Personalized Cancer Care” through the use of DRP® CDx, and also provides us with
an opportunity to monetize certain of our validated DRP® CDx’s that are outside the scope of our own therapeutic development
programs and focus.
Allarity
Therapeutics, Inc. I 24 School Street, 2nd Floor I Boston,
MA I U.S.A. I NASDAQ: ALLR I
www.allarity.com
Additionally, we continue to explore potential strategic partnerships,
merger & acquisition opportunities. Both the Board and the executive management team take evaluation of such potential opportunities
seriously. Our evaluation reflects not only our commitment to advancing the mission and pipeline of Allarity, but also our efforts to
enhance shareholder value.
In closing, over the past year, we have been working tirelessly to
reset the stage for Allarity to enjoy a stronger financial footing. Our goal is to succeed in advancing our clinical programs, thereby
optimizing the potential for enhanced Shareholder value, while also achieving our vision and mission to improve care for cancer patients.
Looking ahead, I am filled with optimism and excitement about the future
of Allarity Therapeutics. Our clinical portfolio of former Big Pharma drug candidates, dovitinib, IXEMPRA®, and especially stenoparib,
together with their respective DRP® CDx’s, holds immense potential for “Realizing the Promise of Personalized Cancer Care”
and improving patient outcomes. Our proprietary DRP® platform continues to demonstrate its predictive power in prospective (as well
as retrospective) clinical trials. This unique combination of novel cancer drug + patient-selective DRP® CDx positions us at the forefront
of personalized medicine, enabling us to positively impact and improve cancer patients’ lives worldwide.
I want to express my deep gratitude to our dedicated Allarity team,
whose unwavering commitment and hard work have been instrumental in overcoming the many obstacles we have faced throughout the last 18
months and brought us to this point of solid advancement toward achieving our mission. Their expertise and passion drive us forward every
day. I want to sincerely thank you, our Shareholders, for your continued support and belief in our team and our important mission, and
to assure you that we remain steadfast in our commitment to creating long-term value.
Thank you for your continuing trust and partnership. I ask you to stay
on this journey with our dedicated team. Allarity Therapeutics will continue to push the boundaries of what is possible in oncology therapeutic
development and to improve the lives of cancer patients worldwide.
With Warm Regards,
James G. Cullem
CEO, Allarity Therapeutics
Allarity
Therapeutics, Inc. I 24 School Street, 2nd Floor I Boston,
MA I U.S.A. I NASDAQ: ALLR I
www.allarity.com
Forward-Looking Statements
This lettter 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,” “toward,” “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, including but not limited to Deflexifol™,
and statements related to the Company’s ability to maintain 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 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 dovitinib or any of our other therapeutic candidates 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 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.
Allarity
Therapeutics, Inc. I 24 School Street, 2nd Floor I Boston,
MA I U.S.A. I NASDAQ: ALLR I
www.allarity.com
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