Allarity Therapeutics Reports Third Quarter 2026 Results and Provides Full Year 2026 Financial Guidance
News originally published by
GlobeNewswire- Ended third quarter with $24.1 million in cash and restricted cash
- Expects positive fourth quarter earnings between $0.01 and $0.04 per share
TARPON SPRINGS, Fla., November 13, 2026 – Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor—
today reported financial results for the third quarter ended September 30, 2026, and provided an update on its clinical and business activities.
Third Quarter 2026 Financial Highlights
- Cash Position: As of September 30, 2026, Allarity had $24.1 million in cash and restricted cash, including $10.0 million in restricted cash.
- R&D Expenses: Research and Development expenses were $4.2 million, compared with $1.2 million in the third quarter of 2025. The increase primarily reflected a $3.2 million charge for manufacturing stenoparib active pharmaceutical ingredient (API) to support drug supply for a potential Phase 3 trial.
- G&A Expenses: General and administrative expenses for the third quarter of 2026 were $1.3 million, unchanged from $1.3 million for the third quarter of 2025.
- Net Loss: Net loss attributable to common stockholders for the third quarter of 2026 was $6.2 million, compared to $2.8 million for the third quarter of 2025. A $3.2 million one-time manufacturing expense accounted for most of the year-over-year increase.
Fourth Quarter and Full Year 2026 Guidance
- Liability Settlement Agreement: Subsequent to quarter-end, Allarity entered into a Settlement and Release Agreement with Novartis Pharma AG relating to liabilities arising from the previously terminated dovitinib license agreement. Under the agreement, Allarity paid $1.0 million in full settlement of an aggregate liability of $4.9 million, plus accrued interest.
- Fourth Quarter and Full Year 2026 Guidance: Allarity is providing guidance for earnings of $0.01 to $0.04 per share in the fourth quarter. The one-time extraordinary gain from extinguishment of debt is expected to exceed operating expenses for the quarter. Allarity anticipates a full year 2026 loss between $0.73 and $0.76 per share. These figures are preliminary and unaudited, and actual results may differ from these estimates. The Company is not providing financial guidance for 2027.
“Completing API manufacturing gives us a head start on drug supply for a potential Phase 3 trial of stenoparib in advanced ovarian cancer while enrollment continues in our Phase 2 studies,” said Thomas Jensen, Chief Executive Officer of Allarity. “We resolved a significant legacy liability and the expected gain from that settlement is the primary driver of our fourth-quarter earnings guidance. Our first contract under the CLIA laboratory services strategy is an early step toward generating revenue from capabilities we built for our own development programs. We're also strengthening the intellectual property behind those programs, with a newly granted Japanese patent that protects our stenoparib DRP® companion diagnostic into 2039.”
Clinical and Drug Development Progress
- Phase 2 Ovarian Cancer Program: Enrollment continued in the Phase 2 trial evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer under U.S. Food and Drug Administration (FDA) Fast Track designation.
- VA-funded Phase 2 Combination Trial: In parallel, the study evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer continued to enroll patients across multiple U.S. Department of Veterans Affairs (VA) medical centers. The combination trial is fully funded by the VA.
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Japanese Patent for the Stenoparib DRP® Companion Diagnostic: In September, the Japan Patent Office granted a patent for the stenoparib DRP® companion diagnostic, providing protection into 2039. The patent further strengthens the intellectual property supporting stenoparib development with its drug-specific DRP® companion diagnostic.
Corporate and Strategic Developments
- CLIA Certification: In July, Allarity announced that its laboratory in Hoersholm, Denmark, had obtained a Certificate of Registration under the Clinical Laboratory Improvement Amendments (CLIA). The certification supports in-house DRP® testing for U.S. clinical trials, including a potential registrational stenoparib trial in advanced ovarian cancer, and enables Allarity to offer laboratory services to other biotechnology and pharmaceutical companies.
- First Contract Under the CLIA Laboratory Services Strategy: Subsequent to quarter-end, in October, Allarity announced its first revenue-generating contract under its newly established CLIA-certified laboratory services strategy. Under the agreement, the Company will provide a European biotechnology company with development, validation and related laboratory services to support implementation of a proprietary precision oncology predictive device for use in the United States.
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Expanded Research Capabilities: Allarity expanded its in-house laboratory capabilities to include proteomics and cell line research, complementing its existing gene-expression and DRP® services. The expanded capabilities support further investigation of stenoparib’s mechanism of action and broaden the research services available to external partners.
"Our priority is to build the clinical evidence that will guide the next stage of stenoparib development," Mr. Jensen concluded. "As we advance that work, we're focused on delivering for our first CLIA services customer and building a laboratory business that can generate revenue alongside our clinical programs."
About Allarity Therapeutics
Allarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage pharmaceutical company focused on developing personalized cancer treatments. The Company is developing stenoparib, a novel PARP/tankyrase inhibitor for patients with advanced ovarian cancer, and is using its proprietary DRP® technology to develop a companion diagnostic designed to identify patients expected to derive the greatest clinical benefit from stenoparib. Allarity’s principal operations are located in Denmark, and its U.S. business address is in Florida. For more information, visit www.allarity.com.
About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. Tankyrases have emerged as potential therapeutic targets in cancer due in part 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, including drug-resistant cancers. Through its inhibition of PARP and the WNT signaling pathway, stenoparib has the potential to provide therapeutic benefit across multiple cancer types, including ovarian cancer, small cell lung cancer and colorectal cancer.
Allarity has secured exclusive global rights to develop and commercialize stenoparib, which was originally developed by Eisai Co., Ltd. and was formerly known as E7449 and 2X-121.
Allarity has completed its first Phase 2 trial evaluating stenoparib in patients with advanced ovarian cancer. The trial demonstrated promising and durable clinical benefit in patients with ovarian cancer who received two or more prior lines of therapy and were treated with stenoparib twice daily. Updated data from the trial were presented at the AACR Special Conference on Advances in Ovarian Cancer in September 2025. These analyses remain subject to change as the study data mature. Based on the emerging clinical experience with stenoparib, Allarity developed a new protocol focused on patients with platinum-resistant ovarian cancer, which began enrolling patients in the summer of 2025. The study initially enrolled platinum-resistant or platinum-ineligible patients and has since expanded eligibility to include patients with primary platinum-refractory disease and patients whose disease is clinically evaluable but not measurable by standard RECIST criteria. The additional patient populations will be assessed separately from the original cohort. The study is designed to advance the clinical development of stenoparib toward potential FDA approval.
In parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for patients with relapsed small cell lung cancer, or SCLC, began enrolling in early 2026 and is currently enrolling patients at multiple U.S. Department of Veterans Affairs sites.
About the Drug Response Predictor – DRP® Companion Diagnostic
Allarity uses its drug-specific DRP® technology to identify patients who, based on the gene expression signature of their cancer, may be more likely to benefit from a particular drug. By screening patients before treatment, and selecting those with a sufficiently high, drug-specific DRP score, the DRP technology is designed to increase the likelihood of therapeutic benefit.
The DRP methodology is based on the comparisons of sensitive and resistant human cancer cell lines, and incorporates transcriptomic data, clinical tumor biology filters and prior clinical trial outcomes. The DRP uses messenger RNA expression profiles derived from patient biopsies to generate drug-specific predictive scores. The DRP® platform has demonstrated the ability to provide statistically significant predictions of clinical outcome following drug treatment across dozens of retrospective and prospective clinical studies. The platform is designed for potential application across multiple cancer types, is patented for dozens of anti-cancer drugs and has been extensively described in peer-reviewed scientific literature.
Follow Allarity on Social Media
LinkedIn: https://www.linkedin.com/company/allaritytx/
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable federal securities laws. Forward-looking statements reflect current expectations or forecasts regarding future events. The words “anticipates,” “believes,” “continues,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “possible,” “potential,” “predicts,” “projects,” “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 regarding the enrollment, conduct and potential results of the Company’s clinical trials; the potential benefits of expanded study eligibility and DRP®-guided patient selection; the development and potential regulatory approval of stenoparib; the availability of drug supply for potential pivotal development; the Company’s financial guidance for the fourth quarter and full year 2026, including the expected accounting impact of the settlement and extinguishment of debt; the potential benefits and commercial opportunities associated with the Company’s CLIA-certified laboratory and expanded research capabilities; potential recurring laboratory service revenues; the scope and duration of patent protection. 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 from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to patient enrollment, trial execution, clinical outcomes and regulatory review; the predictive accuracy and clinical utility of the stenoparib DRP® companion diagnostic; manufacturing quality and drug supply; the possibility that the accounting treatment or financial impact of the settlement may differ from current expectations, and that actual operating expenses, earnings per share or other financial results may differ from the Company’s guidance; maintenance of laboratory certifications and approvals; successful completion of development and validation services and conversion into recurring commercial testing; the scope, validity and enforceability of intellectual property rights; market conditions and the completion of proposed financing transactions; and the Company’s operating costs, debt obligations, liquidity and ability to obtain additional financing. For a discussion of risks and uncertainties and other important factors that could cause actual results to differ materially from those contained in the forward-looking statements, see the risk factors and other disclosures in Allarity’s filings with the SEC, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These filings are available through the SEC’s website. All information in this press release is as of the date of the release, and the Company undertakes no obligation to update or revise this information, except as required by applicable law.
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Company Contact:
investorrelations@allarity.com
ALLARITY THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except for share and per share data)
| September 30, | December 31, | |||||||
| 2026 | 2025 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash | $ | 14,092 | $ | 14,687 | ||||
| Restricted Cash | 9,998 | — | ||||||
| Other current assets | 74 | 265 | ||||||
| Derivative Asset | 8 | — | ||||||
| Prepaid expenses | 987 | 2,110 | ||||||
| Tax credit receivable | 1,707 | 866 | ||||||
| Total current assets | 26,866 | 17,928 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 354 | 330 | ||||||
| Total assets | $ | 27,220 | $ | 18,258 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 4,284 | $ | 4,282 | ||||
| Accrued expenses and other current liabilities | 2,099 | 2,667 | ||||||
| Income taxes payable | 80 | 81 | ||||||
| Promissory note, net of discounts and accrued interest | 21,584 | — | ||||||
| Convertible promissory notes and accrued interest | 1,435 | 1,400 | ||||||
| Total current liabilities | 29,482 | 8,430 | ||||||
| Total liabilities | 29,482 | 8,430 | ||||||
| Commitments and contingencies (Note 9) | ||||||||
| Stockholders’ equity | ||||||||
| Common stock, $0.0001 par value (250,000,000 shares authorized); 19,363,667 and 19,030,619 shares issued and 16,150,028 and 16,080,980 outstanding at September 30, 2026 and December 31, 2025, respectively | 3 | 3 | ||||||
| Additional paid-in capital | 145,099 | 144,233 | ||||||
| Accumulated other comprehensive loss | (1,360 | ) | (1,021 | ) | ||||
| Accumulated deficit | (142,552 | ) | (130,197 | ) | ||||
| Treasury stock, at cost; 3,213,639 and 2,949,639 shares at September 30, 2026, and December 31, 2025, respectively | (3,452 | ) | (3,190 | ) | ||||
| Total stockholders’ equity (deficit) | (2,262 | ) | 9,828 | |||||
| Total liabilities and stockholders’ equity | $ | 27,220 | $ | 18,258 | ||||
ALLARITY THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(in thousands, except for share and per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Revenue: | ||||||||||||||||
| License Revenue | $ | 5 | $ | — | $ | 30 | $ | — | ||||||||
| Total revenue | 5 | — | 30 | — | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 4,219 | 1,203 | 6,861 | 4,927 | ||||||||||||
| General and administrative | 1,293 | 1,315 | 4,035 | 4,760 | ||||||||||||
| Total operating expenses | 5,512 | 2,518 | 10,896 | 9,687 | ||||||||||||
| Loss from operations | (5,507 | ) | (2,518 | ) | (10,866 | ) | (9,687 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 205 | 187 | 585 | 646 | ||||||||||||
| Interest expense | (1,012 | ) | (57 | ) | (1,960 | ) | (126 | ) | ||||||||
| Foreign exchange gain (loss) | (22 | ) | (418 | ) | (122 | ) | 1,308 | |||||||||
| Change in fair value of derivative and warrant liabilities | 136 | — | 8 | 1 | ||||||||||||
| Total other income (expense), net | (693 | ) | (288 | ) | (1,489 | ) | 1,829 | |||||||||
| Net loss | $ | (6,200 | ) | $ | (2,806 | ) | $ | (12,355 | ) | $ | (7,858 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.39 | ) | $ | (0.19 | ) | $ | (0.77 | ) | $ | (0.57 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 15,937,567 | 14,739,800 | 15,942,556 | 13,849,976 | ||||||||||||
| Other comprehensive loss | ||||||||||||||||
| Net loss | $ | (6,200 | ) | $ | (2,806 | ) | $ | (12,355 | ) | $ | (7,858 | ) | ||||
| Change in cumulative translation adjustment | (14 | ) | 158 | (339 | ) | (1,949 | ) | |||||||||
| Total comprehensive loss | $ | (6,214 | ) | $ | (2,648 | ) | $ | (12,694 | ) | $ | (9,807 | ) | ||||
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