Full Press Release Details
Therapeutics Reports Full Year 2023
Financial Results and Provides a Business Update
(March 8, 2024) - Allarity Therapeutics, Inc. ("Company") (NASDAQ: ALLR), a clinical-stage pharmaceutical company
dedicated to developing personalized cancer treatments, today reported financial results for the year ended December 31, 2023, and provided
a general business update.
Company's Interim Chief Executive Officer, Thomas Jensen, stated, "2023 was a year of remarkable achievements for Allarity
Therapeutics as we made significant strides in advancing our DRP -guided drug development. Our clinical research has shown strong
indications that we can address a significant unmet medical need in oncology. In particular, our lead asset, stenoparib, has demonstrated
exceptional promise in advanced ovarian cancer trials. As we continue through 2024, our focus remains on continuing to generate and report
on additional pivotal clinical trial data for stenoparib, which we expect will further strengthen interest in our work from a broad group
of stakeholders, including leading oncologists, potential partner companies, and the biotech investor community."
Highlights and Recent Developments
(2X-121): An orally available, small molecule dual-targeted inhibitor of poly-ADP ribose polymerase (PARP1/2) and telomerase maintenance
enzymes (Tankyrase 1 and 2) in development for advanced ovarian cancer.
Therapeutics, Inc. | 210 Broadway, #201 | Cambridge, MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
leadership changes and strategic advisory engagement:
Clinical Milestones in 2024
focus of the Company remains on generating and disclosing pivotal clinical data to demonstrate the clinical benefit of our DRP guided
therapies. Accordingly, we expect to announce interim data from the DRP -guided Phase 2 clinical trial of stenoparib in advanced
ovarian cancer during the second quarter of 2024. We believe that this milestone is particularly significant as it will provide further
insights into stenoparib's potential to meet the unmet needs in the treatment of advanced ovarian cancer.
Year 2023 Operating Results
Expenses: Research and Development (R&D) expenses were $7.1 million for 2023, compared to $6.9 million for 2022.
Expenses: General and Administrative (G&A) expenses were $10.0 million for 2023, compared to $10.0 million for 2022.
Loss from Operations: Net Loss from Operations was $17.1 million for 2023, compared to $34 million for 2022.
Loss: Net loss was $11.9 million for 2023, compared to $16.1 million for 2022.
the Drug Response Predictor - DRP Companion Diagnostic
uses its drug-specific DRP to select those patients who, by the 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 in
37 out of 47 clinical studies that were examined (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.
Allarity Therapeutics
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.
Therapeutics, Inc. | 24 School Street, 2nd Floor | Boston, MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
Allarity on Social Media
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, statements related to release of the clinical trial data in 2024 and its impact on strengthening interest in our work, the
availability of interim/final data readout from the DRP guided Phase 2 clinical trial of stenoparib for advanced ovarian cancer, the
possibility of a financing in Q1 2024 and expected availability of capital to fund its anticipated clinical trials, 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 and statements related to the Company's ability to regain 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 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, 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 S-1 registration statement filed on October 30, 2023, as amended 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.
Therapeutics, Inc. | 24 School Street, 2nd Floor | Boston, MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
For the years ended December 31, 2023 and 2022
(U.S. dollars in thousands, except for share and per share data)
| 2023 | 2022 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 7,103 | $ | 6,930 | ||||
| Impairment of intangible assets | - | 17,571 | ||||||
| General and administrative | 10,026 | 9,962 | ||||||
| Total operating expenses | 17,129 | 34,463 | ||||||
| Loss from operations | (17,129 | ) | (34,463 | ) | ||||
| Other income (expenses) | ||||||||
| Income from the sale of IP | - | 1,780 | ||||||
| Interest income | 22 | 30 | ||||||
| Interest expenses | (498 | ) | (223 | ) | ||||
| Loss on investment | - | (115 | ) | |||||
| Foreign exchange gains (losses) | 133 | (913 | ) | |||||
| Fair value of inducement warrants | (4,189 | ) | - | |||||
| Loss on modification of warrants | (591 | ) | - | |||||
| Change in fair value adjustment of warrant derivative liabilities | 10,434 | 17,125 | ||||||
| Penalty on Series A Preferred stock liability | - | (800 | ) | |||||
| Net other income, net | 5,311 | 16,884 | ||||||
| Net loss before tax recovery (expense) | (11,818 | ) | (17,579 | ) | ||||
| Deferred income tax (expense) benefit | (83 | ) | 1,521 | |||||
| Net loss | (11,901 | ) | (16,058 | ) | ||||
| Cash payable on converted Series A Preferred Stock | - | (3,421 | ) | |||||
| Deemed dividends on Series A Preferred Stock | (8,392 | ) | - | |||||
| Deemed dividend of on Series C Preferred Stock | (123 | ) | (1,572 | ) | ||||
| Net loss attributable to common stockholders | $ | (20,416 | ) | $ | (21,051 | ) | ||
| Basic and diluted net loss per common stock | $ | (10.26 | ) | $ | (3,093.42 | ) | ||
| Weighted average number of common stock outstanding, basic and diluted | 1,990,748 | 6,805 | ||||||
| Other comprehensive loss, net of tax: | ||||||||
| Net loss | $ | (11,901 | ) | $ | (16,058 | ) | ||
| Change in cumulative translation adjustment | 310 | (121 | ) | |||||
| Comprehensive loss attributable to common stockholders | $ | (11,591 | ) | $ | (16,179 | ) |
Therapeutics, Inc. | 24 School Street, 2nd Floor | Boston, MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
CONSOLIDATED BALANCE SHEETS
As of December 31, 2023 and 2022
(U.S. dollars in thousands, except for share and per share data)
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash | $ | 166 | $ | 2,029 | ||||
| Other current assets | 209 | 1,559 | ||||||
| Prepaid expenses | 781 | 591 | ||||||
| Tax credit receivable | 815 | 789 | ||||||
| Total current assets | 1,971 | 4,968 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 20 | 21 | ||||||
| Operating lease right of use assets | - | 6 | ||||||
| Intangible assets | 9,871 | 9,549 | ||||||
| Total assets | $ | 11,862 | $ | 14,544 | ||||
| LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 8,416 | $ | 6,251 | ||||
| Accrued liabilities | 1,309 | 1,904 | ||||||
| Warrant derivative liability | 3,083 | 374 | ||||||
| Income taxes payable | 59 | 41 | ||||||
| Convertible promissory note and accrued interest, net of debt discount | 1,300 | - | ||||||
| Secured promissory notes | - | 2,644 | ||||||
| Operating lease liabilities, current | - | 8 | ||||||
| Total current liabilities | 14,167 | 11,222 | ||||||
| Non-current liabilities: | ||||||||
| Convertible promissory note and accrued interest, net of debt discount | - | 1,083 | ||||||
| Deferred tax | 446 | 349 | ||||||
| Total liabilities | 14,613 | 12,654 | ||||||
| Redeemable preferred stock (500,000 shares authorized) | ||||||||
| Series A Preferred Stock $0.0001 par value (20,000 shares designated) shares issued and outstanding at December 31, 2023 and 2022, were 1,417 and 13,586, respectively (liquidation preference of $17.54 at December 31, 2023) | - | 2,001 | ||||||
| Series B Preferred Stock $0.0001 par value (200,000 shares designated); shares issued at December 31, 2023 and 2022, were 0 and 190,786, respectively (liquidation preference of $0 at December 31, 2023) | - | 2 | ||||||
| Series C Convertible Preferred stock $0.0001 par value (50,000 and 0 shares designated at December 31, 2023 and 2022, respectively); shares issued and outstanding at December 31, 2023 were 0 | - | - | ||||||
| Total redeemable preferred stock | - | 2,003 | ||||||
| Stockholders' (deficit) equity | ||||||||
| Series A Preferred stock $0.0001 par value (20,000 shares designated) shares issued and outstanding at December 31, 2023 and 2022, were 1,417 and 13,586, respectively (liquidation preference of $17.54 at December 31, 2023) | 1,742 | - | ||||||
| Common Stock, $0.0001 par value (750,000,000 and 30,000,000 shares authorized, at December 31, 2023 and 2022, respectively); shares issued and outstanding at December 31, 2023 and 2022, were 5,886,934 and 11,356, respectively | - | - | ||||||
| Additional paid-in capital | 90,369 | 83,158 | ||||||
| Accumulated other comprehensive loss | (411 | ) | (721 | ) | ||||
| Accumulated deficit | (94,451 | ) | (82,550 | ) | ||||
| Total stockholders' deficit | (2,751 | ) | (113 | ) | ||||
| Total liabilities, preferred stock and stockholders' (deficit) equity | $ | 11,862 | $ | 14,544 |
Therapeutics, Inc. | 24 School Street, 2nd Floor | Boston, MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
Therapeutics, Inc. | 24 School Street, 2nd Floor | Boston, MA | U.S.A. | NASDAQ: ALLR | www.allarity.com