Boston (March 31, 2025) — Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP/WNT pathway inhibitor—today announced financial results for the year ended December 31, 2024, and provided a general business update.
Thomas Jensen, Chief Executive Officer of Allarity Therapeutics, stated:
"2024 was a transformational year for Allarity as we made significant progress in advancing stenoparib as a next-generation treatment for advanced ovarian cancer. Our clinical development efforts continue to advance stenoparib for treatment of heavily pre-treated patients afflicted with ovarian and other cancers. Over the past year, we undertook a comprehensive strategic realignment—streamlining our pipeline, simplifying our capital structure, and strengthening our leadership team with key industry experts. Additionally, we reinforced our financial position, ensuring a strong foundation for continued progress as we restart enrollment in our ongoing Phase 2 trial in ovarian cancer in the first half of 2025. Importantly, we are now positioned with a cash runway that extends into 2027. With this momentum, we are well-positioned to deliver meaningful clinical milestones and create long-term value for patients and shareholders alike."
2024 Highlights and Recent Developments
Clinical and Drug Development Progress
In 2024, Allarity executed a full strategic realignment to focus exclusively on the development of stenoparib, the Company’s novel dual PARP/WNT pathway inhibitor, discontinuing other clinical programs, including dovitinib and IXEMPRA®. This singular focus enabled the Company to accelerate progress across multiple fronts in the stenoparib program and reach several achievements:
Leadership Changes
Financial Strengthening and Corporate Development
Regulatory and Compliance Resolutions
Anticipated Clinical Milestones in 2025
Full Year 2024 Operating Results
Cash Position: As of December 31, 2024, cash and cash receivables totaled $20.9 million compared to $0.2 million at December 31, 2023, an increase of $20.7 million.
R&D Expenses: Research and Development (R&D) expenses were $6.1 million for 2024, compared to $7.1 million for 2023. Additionally, the Company recorded a $9.7 million intangible asset impairment charge (non-cash) in 2024.
G&A Expenses: General and Administrative (G&A) expenses were $11.4 million for 2024, including a $2.5 million accrual for the SEC settlement, compared to $10.0 million for 2023.
Net Loss: Net loss was $24.5 million for 2024, compared to $11.9 million for 2023. The increase from 2023 to 2024 is largely attributable to a $9.7 million non-cash impairment charge and costs related to the SEC investigation, which include a $2.5 million SEC settlement and legal and indemnification expenses.
About Stenoparib
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant Wnt/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121.
About the Drug Response Predictor – DRP® Companion Diagnostic
Allarity uses its drug-specific DRP® to select those patients who, by the gene expression signature of their cancer, may 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 enhanced. 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 shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.
About Allarity Therapeutics
Allarity 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® technology to develop a companion diagnostic that can be used to select those patients expected to derive the greatest clinical benefit from stenoparib. 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 Media
LinkedIn: https://www.linkedin.com/company/allaritytx/
X: https://x.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, statements related to the initiation and progress of the updated Phase 2 protocol for stenoparib in platinum-resistant ovarian cancer, the launch and conduct of the fully VA-funded Phase 2 trial evaluating stenoparib in combination with temozolomide for small cell lung cancer, the durability and regulatory potential of clinical benefit observed in ongoing studies, the Company’s strengthened financial position and expected ability to fund operations into 2027, potential market expansion supported by recent patent grants, and the resolution of regulatory and legal matters. 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 may not be able to secure sufficient capital to support its ongoing and planned clinical development activities, including the updated ovarian cancer protocol and the new VA-funded SCLC trial; the risk that observed clinical benefit, including durable responses and disease stability, may not be replicated in larger or later-stage studies; the risk that final trial data may differ materially from interim observations; the risk that stenoparib may not receive regulatory approval or, if approved, may not achieve commercial success; the potential for delays or challenges in patient enrollment, site activation, or data collection; the risk that the Company’s DRP® companion diagnostic may not be validated or approved for use with stenoparib; and broader operational risks related to market conditions, regulatory developments, or unforeseen external events that could affect the Company’s clinical execution or financial trajectory. 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 filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2025, 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:
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Media Contact:
Thomas Pedersen
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ALLARITY THERAPEUTICS, INC.
Consolidated Balance Sheets
(in thousands, except for share and per share data)
| December 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash | $ | 19,533 | $ | 166 | ||||
| Receivables from ATM sales | 1,416 | — | ||||||
| Other current assets | 115 | 209 | ||||||
| Prepaid expenses | 507 | 781 | ||||||
| Tax credit receivable | 770 | 815 | ||||||
| Total current assets | 22,341 | 1,971 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 309 | 20 | ||||||
| Intangible assets | — | 9,871 | ||||||
| Total assets | $ | 22,650 | $ | 11,862 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,182 | $ | 8,416 | ||||
| Accrued expenses and other current liabilities | 5,232 | 1,309 | ||||||
| Warrant derivative liability | 1 | 3,083 | ||||||
| Income taxes payable | 74 | 59 | ||||||
| Convertible promissory note and accrued interest | 1,350 | 1,300 | ||||||
| Total current liabilities | 10,839 | 14,167 | ||||||
| Non-current liabilities: | ||||||||
| Deferred tax | — | 446 | ||||||
| Total liabilities | 10,839 | 14,613 | ||||||
| Commitments and contingencies (Note 16) | ||||||||
| Stockholders’ equity (deficit) | ||||||||
| Series A Preferred stock, $0.0001 par value, 500,000 authorized, 20,000 designated Series A shares, 0 and 1,417 shares issued and outstanding at December 31, 2024 and 2023, respectively (liquidation preference of $17.54 at December 31, 2023) | — | 1,742 | ||||||
| Common Stock, $0.0001 par value, 250,000,000 and 750,000,000 shares authorized, at December 31, 2024 and 2023, respectively; 7,302,797 and 9,812 shares issued and outstanding at December 31, 2024 and 2023, respectively | 1 | — | ||||||
| Additional paid-in capital | 131,130 | 90,369 | ||||||
| Accumulated other comprehensive loss | (354 | ) | (411 | ) | ||||
| Accumulated deficit | (118,966 | ) | (94,451 | ) | ||||
| Total stockholders’ equity (deficit) | 11,811 | (2,751 | ) | |||||
| Total liabilities and stockholders’ equity (deficit) | $ | 22,650 | $ | 11,862 | ||||
ALLARITY THERAPEUTICS, INC.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except for share and per share data)
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 6,096 | $ | 7,103 | ||||
| Impairment of intangible assets | 9,703 | — | ||||||
| General and administrative | 11,442 | 10,026 | ||||||
| Total operating expenses | 27,241 | 17,129 | ||||||
| Loss from operations | (27,241 | ) | (17,129 | ) | ||||
| Other income (expense) | ||||||||
| Interest income | 533 | 22 | ||||||
| Interest expenses | (653 | ) | (498 | ) | ||||
| Foreign exchange gains (losses) | (212 | ) | 133 | |||||
| Fair value of inducement warrants | — | (4,189 | ) | |||||
| Loss on modification of warrants | — | (591 | ) | |||||
| Change in fair value adjustment of warrant derivative liabilities | 2,677 | 10,434 | ||||||
| Total other income | 2,345 | 5,311 | ||||||
| Loss before income tax expense (benefit) | (24,896 | ) | (11,818 | ) | ||||
| Income tax expense (benefit) | (381 | ) | 83 | |||||
| Net loss | (24,515 | ) | (11,901 | ) | ||||
| Deemed dividends on Series A Preferred Stock | (299 | ) | (8,392 | ) | ||||
| Deemed dividend on Series A Convertible Preferred Stock | (562 | ) | — | |||||
| Gain on extinguishment of Series A Convertible Preferred Stock | 222 | — | ||||||
| Deemed dividend of on Series C Preferred Stock | — | (123 | ) | |||||
| Net loss attributable to common stockholders | $ | (25,154 | ) | $ | (20,416 | ) | ||
| Net loss per common share, basic and diluted | $ | (15.65 | ) | $ | (6,031.31 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 1,606,989 | 3,385 | ||||||
| Other comprehensive loss | ||||||||
| Net loss | $ | (24,515 | ) | $ | (11,901 | ) | ||
| Change in cumulative translation adjustment | 57 | 310 | ||||||
| Total comprehensive loss | $ | (24,458 | ) | $ | (11,591 | ) | ||
| Last Trade: | US$0.80 |
| Daily Change: | 0.0049 0.62 |
| Daily Volume: | 1,367,964 |
| Market Cap: | US$3.530M |
February 24, 2025 February 06, 2025 November 18, 2024 | |
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