NEWS RELEASE
Allarity Therapeutics CEO Letter to Shareholders
8/11/2023
BOSTON, August 11, 2023
Dear Allarity Therapeutics Shareholders:
As we recently marked the end of my
concerns that have been raised, acknowledge challenges we have faced, and highlight the signi
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
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 di
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 o
securing the necessary
pipeline together with our core DRP® companion diagnostics platform.
I am extremely pleased with, and thankful for, the non-stop e
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 e
Our success in raising new capital resulted, among other clinical program progress, in the initiation of Allarity's
combination therapy study, for stenoparib + dovitinib in a Phase 1b/2 clinical trial, in early 2023. This milestone
marks the
last year.
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 bene
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 bene
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 signi
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
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, e
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-quali
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 quali
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 De
formulation of the widely used chemotherapeutic 5-
others, to select and treat cancer patients most likely to respond to De
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.
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 re
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
enhanced Shareholder value, while also achieving our vision and mission to improve care for cancer patients.
Looking ahead, I am
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
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 e
particular patient is likely to respond to a speci
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 di
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 su
the risk that results of a clinical study do not necessarily predict
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 di
10-K annual report on
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
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.
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Allarity Therapeutics Inc. published this content on 11 August 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 11 August 2023 12:05:03 UTC.