ALLR
Allarity TherapeuticsFDocument history
Earnings documents stored for ALLR.
Investor releaseQuarter not tagged2026-08-14Allarity Therapeutics Reports Second Quarter 2026 Results and Completion of the Phase 3-Ready Stenoparib Manufacturing Campaign
GlobeNewswire
Allarity Therapeutics Reports Second Quarter 2026 Results and Completion of the Phase 3-Ready Stenoparib Manufacturing Campaign
- Completed quarter with $26.9 million in cash and restricted cash - Key U.S. patent was awarded, protecting exclusivity of stenoparib when used with the stenoparib-specific DRP® companion diagnostic into 2042 - AACR 2026 data linked higher stenoparib DRP® scores with enhanced overall survival in advanced ovarian cancer, further supporting DRP®-guided patient selection - Obtained CLIA certification for its in-house laboratory, enabling full control of DRP® testing to accelerate and support U.S. clinical trials TARPON SPRINGS, Fla., AUGUST 14, 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 and provided an update on operational highlights for the second quarter ended June 30, 2026. “The second quarter was a highly productive period for Allarity. During the quarter, the USPTO granted the key U.S. patent covering our stenoparib-specific DRP® companion diagnostic, providing exclusivity to develop stenoparib with its DRP® into April 2042. This establishes a critical, long-term intellectual property foundation for stenoparib development and commercialization and reinforces our confidence in the long-term potential of our approach to pairing anticancer therapeutics with drug-specific companion diagnostics,” said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. “Subsequent to quarter-end, we also successfully completed our manufacturing campaign for stenoparib, securing drug supply in accordance with the more stringent standards required for late-stage clinical development. Completion of this campaign represents an important step as we prepare for a pivotal, registrational trial. We have also secured CLIA certification for our in-house laboratory, enabling us to do all of the necessary testing for the DRP® in-house, which will further secure our ability to control and accelerate the advance of stenoparib toward FDA approval. I am particularly proud of these accomplishments as they position the company to drive stenoparib forward as rapidly as possible. Together with the presentation of our promising, durable Phase 2 clinical benefit data in advanced ovarian cancer patients at leading international oncology conferences, these achievements furt…Read full documentShow less
- Completed quarter with $26.9 million in cash and restricted cash - Key U.S. patent was awarded, protecting exclusivity of stenoparib when used with the stenoparib-specific DRP® companion diagnostic into 2042 - AACR 2026 data linked higher stenoparib DRP® scores with enhanced overall survival in advanced ovarian cancer, further supporting DRP®-guided patient selection - Obtained CLIA certification for its in-house laboratory, enabling full control of DRP® testing to accelerate and support U.S. clinical trials TARPON SPRINGS, Fla., AUGUST 14, 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 and provided an update on operational highlights for the second quarter ended June 30, 2026. “The second quarter was a highly productive period for Allarity. During the quarter, the USPTO granted the key U.S. patent covering our stenoparib-specific DRP® companion diagnostic, providing exclusivity to develop stenoparib with its DRP® into April 2042. This establishes a critical, long-term intellectual property foundation for stenoparib development and commercialization and reinforces our confidence in the long-term potential of our approach to pairing anticancer therapeutics with drug-specific companion diagnostics,” said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. “Subsequent to quarter-end, we also successfully completed our manufacturing campaign for stenoparib, securing drug supply in accordance with the more stringent standards required for late-stage clinical development. Completion of this campaign represents an important step as we prepare for a pivotal, registrational trial. We have also secured CLIA certification for our in-house laboratory, enabling us to do all of the necessary testing for the DRP® in-house, which will further secure our ability to control and accelerate the advance of stenoparib toward FDA approval. I am particularly proud of these accomplishments as they position the company to drive stenoparib forward as rapidly as possible. Together with the presentation of our promising, durable Phase 2 clinical benefit data in advanced ovarian cancer patients at leading international oncology conferences, these achievements further strengthen the foundation for accelerating stenoparib toward FDA approval. Finally, I am pleased that we ended the quarter with almost $27 million in cash and restricted cash, providing us with the financial resources to continue the important work of advancing stenoparib.” Clinical and Drug Development Progress Phase 3 manufacturing campaign milestone: During the second quarter, Allarity announced that its active pharmaceutical ingredient (API) manufacturing campaign for stenoparib was progressing in line with the planned timeline at its world-class contract development and manufacturing organization (CDMO). Subsequent to quarter-end, the campaign was successfully completed (July 2026), ahead of the originally planned completion by the third quarter of 2026. The campaign supports accelerating stenoparib toward FDA approval following its FDA Fast Track designation and was completed in anticipation of the generation of clinical benefit data from the ongoing Phase 2 trial in advanced ovarian cancer. All manufacturing-related payments were completed during the second quarter and are recorded as prepaid expenses, and no additional cash outlays for API manufacturing are anticipated. Key U.S. patent granted for the stenoparib DRP® companion diagnostic: The United States Patent and Trademark Office (USPTO) granted the key U.S. patent covering Allarity’s proprietary stenoparib-specific Drug Response Predictor (DRP®) companion diagnostic, with a term extending into April 2042. The grant follows the USPTO’s Notice of Allowance announced in April 2026. The patent covers methods for predicting clinical benefit from stenoparib based on gene-expression profiles derived from tumor samples, as well as methods for selecting patients most likely to benefit from stenoparib treatment, and affords commercial exclusivity protection for stenoparib when used in concert with the stenoparib DRP®. AACR 2026 data linking DRP® to enhanced overall survival in ovarian cancer: At the American Association for Cancer Research Annual Meeting 2026 (AACR 2026), Allarity presented Phase 2 clinical data showing extended overall survival benefit in advanced, platinum-resistant and refractory ovarian cancer patients, particularly in those patients whose tumors have the highest stenoparib DRP® scores. These data reinforce the value of leveraging the DRP-based patient selection strategies to select patients most likely to benefit from stenoparib and to accelerate stenoparib’s advance to FDA approval. AACR 2026 data highlighting stenoparib’s potential in colorectal cancer: In a second AACR 2026 poster, the Company presented new findings demonstrating stenoparib’s mechanism of action—modulating the WNT/β-catenin signaling pathway and inhibiting the growth of human colorectal cancer cell lines at clinically relevant concentrations. The majority of colorectal cancers activate the WNT pathway, enabling cancer progression and metastatic spread. Accordingly, inhibition of the WNT pathway may provide an exciting new therapeutic option for colon and rectal cancers, which remain among the most prevalent and deadly cancers in the United States. Poster presented at ESMO Gynaecological Cancers Congress: Allarity presented a Trial-in-Progress poster outlining the scientific background, study design, and clinical rationale for its ongoing Phase 2 trial evaluating stenoparib in patients with advanced platinum-resistant or platinum-ineligible ovarian cancer. The poster was presented by the study’s Principal Investigator, Kathleen N. Moore, M.D., an internationally recognized specialist in gynecologic oncology and a leading expert in advanced platinum-resistant and platinum-refractory ovarian cancer. Ovarian cancer program continued under FDA Fast Track designation: Allarity continued enrollment in its Phase 2 clinical trial protocol evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The amended protocol is designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum-resistant patients and to accelerate the clinical development of stenoparib toward FDA approval. SCLC combination trial continued enrollment: The Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC)—fully funded by the U.S. Department of Veterans Affairs (VA)—continued enrolling patients across multiple VA medical centers throughout the United States. CLIA certification obtained: Allarity obtained a Certificate of Registration under the Clinical Laboratory Improvement Amendments (CLIA) for its in-house laboratory in Hørsholm, Denmark. The FDA requires that biomarker testing used to select patients for registration trials be performed in a CLIA-certified laboratory environment. For the first time, Allarity is now able to perform its DRP® testing in-house in a CLIA-certified environment to support U.S. clinical trials, including a registrational trial of stenoparib in advanced ovarian cancer. This is expected to reduce reliance on external laboratories, may shorten turnaround times and reduce costs. It also may position the Allarity Therapeutics Medical Laboratory as a preferred CLIA-certified laboratory partner in Northern Europe for other companies seeking to conduct clinical trials in, or commercialize products for the U.S. market. Corporate and Strategic Developments Scientific visibility at Precision Medicine Forum Europe 2026: CEO Thomas Jensen presented at Precision Medicine Forum Europe 2026 in Stockholm, Sweden, discussing stenoparib’s dual mechanism of action and Allarity’s predictive biomarker, as well as the Company’s ongoing Phase 2 trials. Second Quarter 2026 Financial Review Results of Operations for the Three Months Ended June 30, 2026 Cash Position: As of June 30, 2026, cash and restricted cash totaled $26.9 million, compared to $14.7 million as of June 30, 2025. The Company used $2.6 million of cash in operating activities during the quarter. R&D Expenses: Research and development (R&D) expenses were $1.3 million for the quarter ended June 30, 2026, compared to $2.3 million for the quarter ended June 30, 2025. G&A Expenses: General and administrative (G&A) expenses were $1.3 million for the quarter ended June 30, 2026, compared to $1.8 million for the quarter ended June 30, 2025. Total Comprehensive Loss: The total comprehensive loss attributable to common stockholders was $3.7 million for the quarter ended June 30, 2026, compared to $4.2 million for the quarter ended June 30, 2025. For the six months ended June 30, 2026, the loss was $6.5 million, compared to $7.2 million for the six months ended June 30, 2025. About Stenoparib/2X-121Stenoparib 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, especially drug-resistant cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, small cell lung cancer and colorectal 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. Allarity has completed its first Phase 2 trial for stenoparib in advanced ovarian cancer patients. That trial showed promising and durable clinical benefit in ovarian cancer patients who had two or more lines of prior lines of therapy and recieved stenoparib twice daily. The updated data from this study were presented at the AACR special conference on advances in ovarian cancer in September 2025. These analyses are subject to change as follow-up matures. A new protocol was designed expressly to capitalize on this emerging clinical experience with stenoparib in platinum-resistant patients and began enrolling patients in the summer of 2025. This amended protocol enrolls only platinum- resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval. In parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC) began enrolling patients in early 2026 and is currently enrolling patients across multiple VA sites in the U.S. About the Drug Response Predictor – DRP® Companion DiagnosticAllarity 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 Allarity believes may be useful in all cancer types and is patented for dozens of anticancer drugs, has been extensively published in the peer-reviewed literature.About Allarity TherapeuticsAllarity 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’s principal operations are located in Denmark and its U.S. business address is in Florida. The Company is committed to addressing significant unmet medical needs in cancer treatment. For more information, visit www.allarity.com. Follow Allarity on Social MediaLinkedIn: https://www.linkedin.com/company/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 “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “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 regarding the Company’s ongoing and planned clinical development of stenoparib; the enrollment, conduct, timing and potential results of its Phase 2 trials in advanced ovarian cancer and relapsed small cell lung cancer; the potential safety, efficacy, tolerability and clinical benefit of stenoparib; the potential use of the stenoparib DRP® companion diagnostic for patient selection; the advancement of stenoparib toward pivotal development, FDA approval and commercialization; the availability of drug supply from the completed manufacturing campaign; the anticipated benefits of the Company’s CLIA-certified laboratory; the potential commercial use of the DRP® platform and laboratory services; the scope and duration of patent protection for stenoparib and the stenoparib DRP® companion diagnostic; and the Company’s anticipated cash runway and ability to fund its operations and development plans. 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 clinical development, patient enrollment, trial execution and regulatory review; the possibility that clinical results may not demonstrate the anticipated safety, efficacy, durability or clinical benefit of stenoparib; the predictive accuracy, validation, regulatory acceptance and clinical utility of the stenoparib DRP® companion diagnostic; the Company’s ability to obtain, maintain and enforce intellectual property protection; the quality, availability and regulatory compliance of stenoparib drug supply; the Company’s ability to maintain its CLIA certification and other required laboratory approvals; the possibility that anticipated efficiencies, cost savings or commercial opportunities may not be realized; reliance on third-party clinical sites, investigators, manufacturers and suppliers; and the Company’s ability to maintain sufficient financial resources and obtain additional funding, if required. 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 30, 2026, available at the SEC’s website at www.sec.gov, 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: [email protected] Media Contact: Thomas Pedersen Carrotize PR & Communications +45 6062 9390 [email protected] ALLARITY THERAPEUTICS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands, except for share and per share data) ALLARITY THERAPEUTICS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(UNAUDITED)(in thousands, except for share and per share data) Attachment Allarity Therapeutics Press Release - Allarity Therapeutics Reports Second Quarter 2026 Results
Investor releaseQuarter not tagged2026-05-16Allarity Therapeutics Reports First Quarter 2026 Results and Continued Stenoparib Development in Multiple Cancers
GlobeNewswire
Allarity Therapeutics Reports First Quarter 2026 Results and Continued Stenoparib Development in Multiple Cancers
- Stenoparib clinical development continues in relapsed small cell lung cancer and, under FDA Fast Track designation, in advanced ovarian cancer - Allarity has received a Notice of Allowance for new intellectual property covering its stenoparib-specific DRP® companion diagnostic - Strong financial position maintained with approximately $29.8 million in cash and restricted cash as of March 31, 2026 TARPON SPRINGS, Fla., MAY 15, 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 and provided an update on operational highlights for the first quarter ended March 31, 2026. “Q1 2026 was an especially exciting period for Allarity. While we continue to accelerate stenoparib clinical development in advanced ovarian cancer, we have also begun to expand the reach for stenoparib into new cancer indications. Indeed, in Q1, we started enrolling relapsed small cell lung cancer patients onto the VA-funded trial combining stenoparib with temozolomide. This trial may help establish stenoparib as the combination agent of choice in the PARP inhibitor class. Moreover, we reported new preclinical data suggesting that stenoparib’s unique mechanism of action may make it an attractive therapy. And, we continued to strengthen the DRP® companion diagnostic strategy to help identify the patients most likely to benefit from stenoparib. Critically important, we were also notified that one of our critical U.S. patent applications has been allowed, expanding the time horizon for stenoparib’s exclusivity,” said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. “Financially, we also excelled, ending the quarter with a significant cash position and a P&L profile consistent with the prior-year period. Net loss per share was lower compared with the prior-year period, and separately, we reduced our outstanding share count during the quarter through our repurchase program. We believe this combination of clinical and preclinical progress, a Notice of Allowance for new intellectual property and financial discipline solidifies the strongest position Allarity has ever had,” Mr. Jensen continued. Clinical and Drug Development Progress Stenoparib Phase 3-ready drug production campai…Read full documentShow less
- Stenoparib clinical development continues in relapsed small cell lung cancer and, under FDA Fast Track designation, in advanced ovarian cancer - Allarity has received a Notice of Allowance for new intellectual property covering its stenoparib-specific DRP® companion diagnostic - Strong financial position maintained with approximately $29.8 million in cash and restricted cash as of March 31, 2026 TARPON SPRINGS, Fla., MAY 15, 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 and provided an update on operational highlights for the first quarter ended March 31, 2026. “Q1 2026 was an especially exciting period for Allarity. While we continue to accelerate stenoparib clinical development in advanced ovarian cancer, we have also begun to expand the reach for stenoparib into new cancer indications. Indeed, in Q1, we started enrolling relapsed small cell lung cancer patients onto the VA-funded trial combining stenoparib with temozolomide. This trial may help establish stenoparib as the combination agent of choice in the PARP inhibitor class. Moreover, we reported new preclinical data suggesting that stenoparib’s unique mechanism of action may make it an attractive therapy. And, we continued to strengthen the DRP® companion diagnostic strategy to help identify the patients most likely to benefit from stenoparib. Critically important, we were also notified that one of our critical U.S. patent applications has been allowed, expanding the time horizon for stenoparib’s exclusivity,” said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. “Financially, we also excelled, ending the quarter with a significant cash position and a P&L profile consistent with the prior-year period. Net loss per share was lower compared with the prior-year period, and separately, we reduced our outstanding share count during the quarter through our repurchase program. We believe this combination of clinical and preclinical progress, a Notice of Allowance for new intellectual property and financial discipline solidifies the strongest position Allarity has ever had,” Mr. Jensen continued. Clinical and Drug Development Progress Stenoparib Phase 3-ready drug production campaign is on track for third-quarter completion. Subsequent to quarter-end, Allarity announced that its active pharmaceutical ingredient manufacturing (API) campaign for stenoparib is progressing in line with the planned timeline for completion in the third quarter of 2026. No additional cash outlays for this API manufacturing campaign are anticipated. Stenoparib DRP® companion diagnostic received USPTO Notice of Allowance: Subsequent to quarter-end, the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for Allarity’s patent application covering the Company’s DRP® companion diagnostic specific to stenoparib. The allowed application, if issued as a patent, is expected to extend exclusivity at least another 11 years for stenoparib when used in concert with the DRP® as a companion diagnostic. AACR 2026 data on DRP® findings in ovarian cancer: Subsequent to quarter-end, Allarity presented clinical data at the American Association for Cancer Research Annual Meeting 2026 (AACR 2026) demonstrating that the highest stenoparib DRP® scores were associated with the greatest overall survival in patients treated with stenoparib, reinforcing the potential value of DRP-based patient selection. AACR 2026 data indicated stenoparib’s potential in colorectal cancer: Allarity also presented new findings demonstrating stenoparib’s ability to modulate the WNT/β-catenin signaling pathway and inhibit the growth of human colorectal cancer cell lines at clinically relevant concentrations. VA-funded Phase 2 lung cancer trial opened for enrollment and initiated patient dosing: During the first quarter, Allarity announced that enrollment had opened and the first patients had been dosed in its collaborative investigator-initiated Phase 2 trial with the U.S. Department of Veterans Affairs (VA) evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer. The trial, which represents the first clinical evaluation of stenoparib in combination with another anti-cancer agent, is fully funded through the VA’s Special Emphasis Panel on Precision Oncology and is open for enrollment across 11 VA medical centers throughout the United States. Ovarian cancer program continued under FDA Fast Track designation: Allarity continued enrollment in its Phase 2 clinical trial protocol evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The amended protocol is designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum-resistant patients and to accelerate the clinical development of stenoparib toward FDA approval. Corporate and Strategic Developments Closed $20 million promissory note financing to strengthen the Company’s financial position. During the first quarter, Allarity also secured a $6 million equity line of credit to support the continued advancement of stenoparib. Reduced outstanding share count during the quarter while decreasing the net loss per share, reflecting the Company’s continued financial discipline and operational execution. First Quarter 2026 Financial Highlights Results of Operations for the Three Months Ended March 31, 2026 Cash Position: As of March 31, 2026, cash and restricted cash totaled $29.8 million, compared to total cash and restricted cash of $27.7 million at March 31, 2025. Prepaid Expenses: Prepaid expenses increased to $3.5 million at March 31, 2026, compared to $2.1 million at December 31, 2025, primarily reflecting payments related to stenoparib API manufacturing activities supporting potential pivotal-stage development. R&D Expenses: Research and Development (R&D) expenses were $1.3 million for the quarter ended March 31, 2026, compared to $1.4 million for the quarter ended March 31, 2025. G&A Expenses: General and Administrative (G&A) expenses were $1.4 million for the quarter ended March 31, 2026, compared to $1.6 million for the quarter ended March 31, 2025. Net Loss: Net loss attributable to common stockholders was $2.75 million for the quarter ended March 31, 2026, compared to $2.73 million for the quarter ended March 31, 2025. Net loss per common share was $0.17 for the quarter ended March 31, 2026, compared to $0.25 for the quarter ended March 31, 2025. About Stenoparib/2X-121 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, small cell lung cancer and colorectal 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. Allarity has two ongoing Phase 2 trial protocols for stenoparib in ovarian cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at the AACR special conference on advances in ovarian cancer in September 2025. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients in the summer of 2025. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval. In parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC) began enrolling patients in early 2026 and is currently enrolling patients across multiple VA sites. 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’s principal operations are located in Denmark and its U.S. business address is in Florida 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/ 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 regarding the Company’s ongoing and planned clinical development of stenoparib, including its Phase 2 clinical programs in advanced ovarian cancer and relapsed small cell lung cancer; the potential clinical relevance of stenoparib’s dual inhibition of PARP and the WNT pathway; the potential utility and regulatory advancement of the Company’s stenoparib DRP® companion diagnostic; the Company’s ability to generate clinical data supporting regulatory advancement and potential FDA approval of stenoparib; and the Company’s ability to pursue strategic, scientific, and business development opportunities; and statements regarding the expected timing and completion of the Company’s stenoparib API manufacturing campaign, the anticipated absence of additional cash outlays for such campaign, the expected issuance, scope, and potential exclusivity benefits of intellectual property covering the stenoparib DRP® companion diagnostic, and the Company’s ability to advance stenoparib clinically and through regulatory pathways using its DRP®-guided development strategy. 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, risks related to clinical development and regulatory review of stenoparib; the possibility that ongoing or future clinical trials may not support safety, efficacy, durability, overall survival, or biomarker-related claims; risks related to patient enrollment, clinical trial execution, and timing of data readouts; the predictive accuracy, validation, regulatory acceptance, and clinical utility of the Company’s stenoparib DRP® companion diagnostic; and the Company’s ability to secure sufficient funding, partnerships, or other strategic resources to support its development plans; risks related to delays, increased costs, supply constraints, or other challenges in completing the stenoparib API manufacturing campaign; and risks that anticipated patent issuance, patent scope, enforceability, or exclusivity benefits for the stenoparib DRP® companion diagnostic may not be realized. 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 30, 2026, available at the SEC’s website at www.sec.gov, 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: [email protected] Media Contact: Thomas Pedersen Carrotize PR & Communications +45 6062 9390 [email protected] ALLARITY THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except for share and per share data) ALLARITY THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) (in thousands, except for share and per share data) Attachment Allarity Therapeutics - 10Q Q1 2026
Investor releaseQuarter not tagged2026-03-31Allarity Therapeutics Reports Full Year 2025 Financial Results and Corporate Progress
GlobeNewswire
Allarity Therapeutics Reports Full Year 2025 Financial Results and Corporate Progress
Strengthened financial position through disciplined cost management, with a year-end 2025 cash position of $14.7 million and runway into mid-2028 Received FDA Fast Track designation for stenoparib, enabling accelerated development in advanced ovarian cancer Durable clinical benefit observed in ongoing stenoparib ovarian cancer study, including patients treated for nearly 30 months, with new Phase 2 protocol implemented Expansion of stenoparib development beyond ovarian cancer with the launch of a VA-funded Phase 2 combination study in recurrent small cell lung cancer TARPON SPRINGS, Fla., March 31, 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 announced financial results for the year ended December 31, 2025. “2025 was a year of continued execution and clinical progress for Allarity as we advanced stenoparib toward pivotal trials, FDA approval and commercialization in ovarian cancer. The FDA’s Fast Track designation for stenoparib underscores both the encouraging clinical benefit we have observed to date and the significant unmet medical need in this patient population. Over the course of the year, we initiated enrollment in a new Phase 2 clinical trial protocol designed to optimize dosing and refine future DRP-based patient selection in platinum-resistant ovarian cancer patients. This protocol reflects the compelling and durable clinical benefit we have observed throughout 2024 and 2025 and supports the acceleration of stenoparib’s development,” stated Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. “Furthermore, we broadened the potential reach of stenoparib through the launch of our first combination study evaluating stenoparib with temozolomide in recurrent small cell lung cancer in collaboration with the U.S. Veterans Administration. At the same time, we strengthened the scientific foundation of stenoparib through new mechanistic research collaborations, expanded the reach of our DRP® companion diagnostic platform through revenue-generating licensing agreements, and strengthened our leadership team. We achieved this while also reducing cash used in operating activities by approximately $2.4 million. These achievements position Allarity to deliver meanin…Read full documentShow less
Strengthened financial position through disciplined cost management, with a year-end 2025 cash position of $14.7 million and runway into mid-2028 Received FDA Fast Track designation for stenoparib, enabling accelerated development in advanced ovarian cancer Durable clinical benefit observed in ongoing stenoparib ovarian cancer study, including patients treated for nearly 30 months, with new Phase 2 protocol implemented Expansion of stenoparib development beyond ovarian cancer with the launch of a VA-funded Phase 2 combination study in recurrent small cell lung cancer TARPON SPRINGS, Fla., March 31, 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 announced financial results for the year ended December 31, 2025. “2025 was a year of continued execution and clinical progress for Allarity as we advanced stenoparib toward pivotal trials, FDA approval and commercialization in ovarian cancer. The FDA’s Fast Track designation for stenoparib underscores both the encouraging clinical benefit we have observed to date and the significant unmet medical need in this patient population. Over the course of the year, we initiated enrollment in a new Phase 2 clinical trial protocol designed to optimize dosing and refine future DRP-based patient selection in platinum-resistant ovarian cancer patients. This protocol reflects the compelling and durable clinical benefit we have observed throughout 2024 and 2025 and supports the acceleration of stenoparib’s development,” stated Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. “Furthermore, we broadened the potential reach of stenoparib through the launch of our first combination study evaluating stenoparib with temozolomide in recurrent small cell lung cancer in collaboration with the U.S. Veterans Administration. At the same time, we strengthened the scientific foundation of stenoparib through new mechanistic research collaborations, expanded the reach of our DRP® companion diagnostic platform through revenue-generating licensing agreements, and strengthened our leadership team. We achieved this while also reducing cash used in operating activities by approximately $2.4 million. These achievements position Allarity to deliver meaningful clinical milestones and create long-term value for patients and shareholders alike.” 2025 Corporate Highlights and Recent Developments Clinical and Drug Development Progress Stenoparib received Fast Track designation from the U.S. Food and Drug Administration for the treatment of advanced ovarian cancer, enabling more frequent regulatory engagement and the potential for accelerated review pathways. Durable Clinical Benefit as monotherapy dosed twice daily observed: Updated analyses from the ongoing Phase 2 study in advanced ovarian cancer continued to demonstrate durable clinical benefit in heavily pre-treated patients. Certain patients have remained on therapy nearly 30 months, highlighting the long-term therapeutic potential of stenoparib in this population. New Trial Protocol Implemented and Enrolling: Following an in-depth review of maturing clinical data and consultation with leading gynecologic oncologists, the Company implemented a new Phase 2 clinical trial protocol during 2025 designed to accelerate stenoparib’s development toward pivotal studies, regulatory approval and eventual commercialization. The protocol focuses on patients with advanced, recurrent platinum-resistant or platinum-ineligible ovarian cancer—a population with limited therapeutic options—and aims to optimize stenoparib dosing while refining the DRP® companion diagnostic to better identify patients most likely to benefit from treatment. First Combination Trial Launched: During 2025, Allarity announced and initiated a Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer (SCLC), fully funded by the U.S. Veterans Administration. This study represents the first clinical evaluation of the stenoparib–temozolomide combination and expands the development potential of stenoparib beyond ovarian cancer into additional tumor types with significant unmet medical need. Stenoparib has demonstrated a favorable tolerability profile in clinical studies to date, which may support its use in combination with DNA-damaging agents such as temozolomide while potentially avoiding the dose-limiting hematologic toxicities that have historically constrained the use of 1st generation PARP inhibitors in combination regimens. Preparations for the study were completed during 2025, and the trial subsequently opened for enrollment across 11 VA medical centers in the United States, with the first patients dosed in early 2026. Presentations of Scientific and Clinical Data: The Company presented updated clinical and scientific data at multiple major oncology conferences during 2025, including the AACR Special Conference on Ovarian Cancer and the AACR Annual Meeting, highlighting stenoparib’s clinical outcomes as well as the expanding capabilities of the DRP® platform. Leadership Changes During 2025, Allarity strengthened its leadership team and governance structure. Jeff Ervin was appointed Chief Financial Officer of Allarity Therapeutics in July 2025. Mr. Ervin brings nearly two decades of executive leadership experience across healthcare and biotechnology, including previous roles as Chief Executive Officer of NASDAQ-listed IMAC Holdings and Co-Chief Financial Officer at NYSE-listed DDC Enterprises. Jesper Høiland was appointed to the Company’s Board of Directors in 2025. Mr. Høiland brings more than three decades of global pharmaceutical leadership experience, including senior executive roles at Novo Nordisk and Ascendis Pharma. Corporate Development and Financial Strengthening DRP® Platform Expansion: Allarity initiated commercial licensing of its DRP® companion diagnostic platform, marking an important step toward broader external utilization of the Company’s proprietary patient-selection technology. Allarity Medical Laboratory Growth: In connection with the licensing of its DRP® companion diagnostic platform, Allarity’s Medical Laboratory in Denmark also became a supplier of commercial transcriptomic analysis services, supporting the generation of laboratory service revenue. IP Portfolio Expansion: The Company strengthened its intellectual property portfolio through the acceptance of an Australian patent covering the stenoparib DRP companion diagnostic. Recent Financing: In March 2026, Allarity closed a $20 million non-convertible debt financing with Streeterville Capital designed to accelerate the advancement of stenoparib toward pivotal development, FDA approval and commercialization and extend the Company’s cash runway into mid-2028. 2025 Financial Results Results of Operations for the Twelve Months Ended December 31, 2025, compared to the Twelve Months Ended December 31, 2024. Cash Position: As of December 31, 2025, cash totaled $14.7 million, compared to $19.5 million at December 31, 2024. Total Liabilities: As of December 31, 2025, liabilities declined $2.5 million to $8.4 million, compared to $10.8 million on December 31, 2024. Revenue: The company generated $320 thousand during the fourth quarter and for the entire year ended December 31, 2025. There was no revenue in 2024. R&D Expenses: Research and Development (R&D) expenses were $6.6 million for 2025, compared to $6.1 million for 2024. G&A Expenses: General and Administrative (G&A) expenses were $6.3 million for 2025, compared to $11.4 million for 2024. Net Loss: The net loss attributable to shareholders was $11.2 million for 2025, compared to $25.1 million for 2024, representing an improvement of approximately $4.5 million year-over-year, excluding a $9.7 million non-cash asset impairment in 2024. The improvement in net loss, $0.78 per share in 2025 compared to $15.65 per share in 2024, reflects continued cost discipline and operational efficiencies as the company advanced the clinical development of stenoparib. About Stenoparib/2X-121 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, Small Cell Lung Cancer and colorectal 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. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at this AACR special conference on advances in Ovarian Cancer. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients this summer. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval. 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/ 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 regarding the continued clinical development of stenoparib (2X-121) in advanced ovarian cancer and small cell lung cancer; the completion of Phase 2 enrollment; anticipated timing of critical clinical data; preparation for and timing of End-of-Phase-2 FDA meeting; potential initiation of pivotal development; the development and potential prospective use of the Company’s DRP® companion diagnostic platform; and potential exploratory development of stenoparib in additional oncology indications, including other WNT-driven tumor types; the anticipated use of proceeds from the debt financing; and the filing of a Current Report on Form 8-K. 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, risks related to clinical development and regulatory review, including the possibility that future clinical data, may not support safety, efficacy, or durability claims; risks that Phase 2 enrollment may not be completed as planned; delays in patient enrollment or trial completion; risks associated with preparation for or outcome of End-of-Phase-2 FDA meeting; uncertainties regarding potential initiation or timing of pivotal development; reliance on third-party investigators, clinical sites, and manufacturing partners; the predictive accuracy, regulatory acceptance, and clinical utility of the DRP® platform; risks related to exploratory development in additional tumor types; and the Company’s ability to secure sufficient funding or strategic partnerships to support its operations and development plans; risks relating to the Company’s ability to deploy the proceeds as anticipated, satisfy its obligations under the debt instruments, and complete and timely file the Form 8-K. 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, and our Form 10-Q quarterly reports filed with the SEC on May 9, 2025, August 15, 2025 and November 14, 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: [email protected] Media Contact: Thomas Pedersen Carrotize PR & Communications +45 6062 9390 [email protected] ALLARITY THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except for share and per share data) ALLARITY THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS Attachment Allarity Therapeutics Press Release - Full Year 2025 Financial Results and Corporate Progress
Investor releaseQuarter not tagged2025-11-14Allarity Therapeutics Provides Third Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire
Allarity Therapeutics Provides Third Quarter 2025 Financial Results and Provides Business Updates
Received FDA Fast Track designation for stenoparib in advanced ovarian cancer Reported landmark median overall survival now exceeding 25 months in ongoing Phase 2 trial Advanced DRP® platform through new licensing agreement TARPON SPRINGS, Fla., November 14, 2025 – 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 and provided an update on operational highlights for the third quarter ended September 30, 2025. “The third quarter of 2025 was another milestone period for Allarity as we achieved FDA Fast Track designation for stenoparib in advanced ovarian cancer—an important acknowledgment of the potential of our lead program. We also reported new clinical data showing median overall survival now exceeding 25 months for patients in our Phase 2 trial—a remarkable finding in this difficult-to-treat population. Alongside these achievements, we continued to advance our DRP platform commercially through a new licensing and laboratory services agreement,” said Thomas Jensen, CEO of Allarity Therapeutics. “The consistency of our progress reflects our disciplined, focused strategy and execution. Stenoparib continues to show durable clinical benefit in women with advanced, platinum resistant ovarian cancer, and we continue to deepen our understanding of its unique dual mechanism of action through our collaboration with the Indiana Biosciences Research Institute. With both the ongoing ovarian cancer trial progressing under Fast Track designation and the forthcoming U.S. Veterans Administration–funded small cell lung cancer combination study advancing toward initiation, we see the potential to broaden stenoparib’s therapeutic reach—offering new hope for patients across multiple hard-to-treat cancer types.” Clinical and Drug Development Progress FDA Fast Track designation: In August 2025, the U.S. Food and Drug Administration granted Fast Track designation to stenoparib for the treatment of advanced ovarian cancer, recognizing the significant unmet medical need in this patient population. The designation enables more frequent interactions with the FDA and potential eligibility for accelerated and priority review pathways. Landmark survival data: In September 2025, at the AA…Read full documentShow less
Received FDA Fast Track designation for stenoparib in advanced ovarian cancer Reported landmark median overall survival now exceeding 25 months in ongoing Phase 2 trial Advanced DRP® platform through new licensing agreement TARPON SPRINGS, Fla., November 14, 2025 – 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 and provided an update on operational highlights for the third quarter ended September 30, 2025. “The third quarter of 2025 was another milestone period for Allarity as we achieved FDA Fast Track designation for stenoparib in advanced ovarian cancer—an important acknowledgment of the potential of our lead program. We also reported new clinical data showing median overall survival now exceeding 25 months for patients in our Phase 2 trial—a remarkable finding in this difficult-to-treat population. Alongside these achievements, we continued to advance our DRP platform commercially through a new licensing and laboratory services agreement,” said Thomas Jensen, CEO of Allarity Therapeutics. “The consistency of our progress reflects our disciplined, focused strategy and execution. Stenoparib continues to show durable clinical benefit in women with advanced, platinum resistant ovarian cancer, and we continue to deepen our understanding of its unique dual mechanism of action through our collaboration with the Indiana Biosciences Research Institute. With both the ongoing ovarian cancer trial progressing under Fast Track designation and the forthcoming U.S. Veterans Administration–funded small cell lung cancer combination study advancing toward initiation, we see the potential to broaden stenoparib’s therapeutic reach—offering new hope for patients across multiple hard-to-treat cancer types.” Clinical and Drug Development Progress FDA Fast Track designation: In August 2025, the U.S. Food and Drug Administration granted Fast Track designation to stenoparib for the treatment of advanced ovarian cancer, recognizing the significant unmet medical need in this patient population. The designation enables more frequent interactions with the FDA and potential eligibility for accelerated and priority review pathways. Landmark survival data: In September 2025, at the AACR 7th Biennial Special Conference on Ovarian Cancer, Allarity presented new Phase 2 data showing that median overall survival for patients receiving twice-daily stenoparib has not yet been reached and now exceeds 25 months. Ongoing trial enrollment: Enrollment continued in the new Phase 2 trial protocol evaluating stenoparib in recurrent, platinum-resistant or platinum-ineligible advanced ovarian cancer. The study has maintained steady investigator engagement and is expected to generate critical data by end of 2026. IBRI research collaboration: Work with the Indiana Biosciences Research Institute (IBRI) remains on track, with molecular and cellular studies underway to clarify the individual and combined contributions of PARP inhibition and WNT pathway modulation to stenoparib’s anticancer activity. This research aims to deepen the Company’s mechanistic understanding of the molecule and support future development opportunities in ovarian cancers as well as other cancers such as Small Cell Lung Cancer and potentially Colorectal Cancer. Corporate and Strategic Developments DRP® platform expansion: Signed a new commercial agreement with an EU-based biotechnology company providing a non-exclusive global license to selected breast cancer DRP algorithms and securing laboratory service commitments through the Allarity Medical Laboratory in Denmark. Scientific visibility and partnering: In October 2025, CEO Thomas Jensen presented at Biomarkers & Precision Medicine 2025 in London, highlighting the role of the stenoparib DRP® companion diagnostic in optimizing patient selection and advancing precision oncology. Earlier in the third quarter, new survival data from the ongoing ovarian cancer trial were also presented at the AACR 7th Biennial Special Conference on Ovarian Cancer—a premier scientific forum hosted by the American Association for Cancer Research. Financial position: Ended the third quarter with a solid cash position, consistent with prior guidance, maintaining a financial runway through Q4 2026. Anticipated Clinical Milestones in 2025–2026 Ovarian cancer trial progress: Continued extension of median Overall Survival in the first Ovarian cancer trial using twice daily dosing. Fast-paced enrollment in the new protocol in platinum resistant or ineligible ovarian cancer patients. SCLC combination trial launch: U.S. Veterans Administration–funded Phase 2 trial of stenoparib plus temozolomide in recurrent small cell lung cancer expected to be open for enrollment by year-end 2025. This represents the first combination study for stenoparib and may demonstrate that the safety profile of stenoparib makes it an ideal drug for combination therapy. Third Quarter 2025 Financial Highlights Cash Position: As of September 30, 2025, Allarity finished the quarter with $16.9 million in cash, a decrease of $0.9 million since June 30, 2025. The Company continues to maintain a financial runway to December 2026. R&D Expenses: Research and development expenses for the third quarter of 2025 were $1.2 million, compared to $1.0 million for the third quarter of 2024. G&A Expenses: General and administrative expenses for the third quarter of 2025 were $1.3 million, compared to $1.6 million for the third quarter of 2024. Net Loss: Net loss attributable to common stockholders for the third quarter of 2025 was $2.8 million, compared to a net loss of $12.2 million for the third quarter of 2024. About Stenoparib/2X-121 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, Small Cell Lung Cancer and colorectal 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. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at this AACR special conference on advances in Ovarian Cancer. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients this summer. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval. 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/ 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 regarding the continued clinical development of stenoparib (2X-121) in advanced ovarian cancer and small cell lung cancer; the initiation, enrollment, and expected data readouts from ongoing and future clinical trials; the potential safety, efficacy, and durability of clinical benefit of stenoparib; the potential for regulatory advancement, including under FDA Fast Track designation; and the expansion and potential commercial application of the Company’s DRP® companion diagnostic platform, including in antibody-based therapies. 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, risks related to clinical development and regulatory review, including the possibility that future clinical data may not support safety or efficacy claims; delays in patient enrollment or trial completion; reliance on third-party investigators and trial sites; the outcome and timing of decisions by regulatory authorities, including under Fast Track designation; the predictive accuracy and clinical utility of the DRP® platform; and the Company’s ability to secure sufficient funding or partnerships to support its operations and development plans. 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, and our Form 10-Q quarterly reports filed with the SEC on May 9, 2025, August 15, 2025 and November 14, 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: [email protected] Media Contact: Thomas Pedersen Carrotize PR & Communications +45 6062 9390 [email protected] ALLARITY THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except for share and per share data*) * All common share data has been retroactively adjusted to effect reverse stock splits in 2024 (See Note 1 in our Form 10-Q quarterly report filed with the SEC on November 14, 2025, available at the SEC’s website at www.sec.gov). ALLARITY THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) (in thousands, except for share and per share data*) * All common share data has been retroactively adjusted to effect reverse stock splits in 2024 (See Note 1 in our Form 10-Q quarterly report filed with the SEC on November 14, 2025, available at the SEC’s website at www.sec.gov). Attachment Allarity Therapeutics Press Release - Third Quarter 2025 Financial Results and Business Updates
Investor releaseQuarter not tagged2025-08-16Allarity Therapeutics Provides Second Quarter 2025 Update, Highlighting Clinical Progress, IP Expansion, and New Partnerships
GlobeNewswire
Allarity Therapeutics Provides Second Quarter 2025 Update, Highlighting Clinical Progress, IP Expansion, and New Partnerships
- Successfully initiated enrollment in advanced Phase 2 ovarian cancer trial - Expanded global IP protection by securing Australian patent acceptance for the stenoparib DRP® companion diagnostic - Secured new service contract with EU biotech for Allarity Medical Laboratory TARPON SPRINGS, Fla., August 15, 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 and WNT pathway inhibitor—today reported financial results and provided an update on operational highlights for the second quarter ended June 30, 2025. “The second quarter of 2025 marked a period of strong operational execution for Allarity. Most notably, we continued to advance our lead program, stenoparib, with strong momentum in our new ovarian cancer trial protocol. In parallel, we expanded our proprietary DRP® platform—both through a new commercial agreement granting a non-exclusive global license for our breast cancer DRP to a partner company, and scientifically with the development of a new DRP for the antibody therapy, daratumumab. On the financial front, we maintained a solid cash position and reduced liabilities, including a $2 million reduction in accounts payable and accrued expenses during the quarter. These developments position us well to deliver on our upcoming clinical milestones,” said Thomas Jensen, CEO of Allarity Therapeutics. “I would also like to take the opportunity to look further back, as I have now been the CEO for just over 1.5 years. I’m struck by how quickly our Company’s situation has improved. Just a year ago, we were still working to regain compliance with Nasdaq’s listing requirements. At the same time, we had just completed the cleanup of a previously complex capitalization table—which had deterred many prospective investors—and we had committed to a more focused strategy centered solely on the advancement of stenoparib. Thanks to the dedication of our team, the guidance of our board, and the support of our shareholders, we have resolved all compliance and regulatory matters, strengthened our leadership with seasoned management professionals bringing extensive life sciences experience to our board and executive team, and are successfully executing our stenoparib-focused strategy—having launched a refined monotherapy trial protocol, w…Read full documentShow less
- Successfully initiated enrollment in advanced Phase 2 ovarian cancer trial - Expanded global IP protection by securing Australian patent acceptance for the stenoparib DRP® companion diagnostic - Secured new service contract with EU biotech for Allarity Medical Laboratory TARPON SPRINGS, Fla., August 15, 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 and WNT pathway inhibitor—today reported financial results and provided an update on operational highlights for the second quarter ended June 30, 2025. “The second quarter of 2025 marked a period of strong operational execution for Allarity. Most notably, we continued to advance our lead program, stenoparib, with strong momentum in our new ovarian cancer trial protocol. In parallel, we expanded our proprietary DRP® platform—both through a new commercial agreement granting a non-exclusive global license for our breast cancer DRP to a partner company, and scientifically with the development of a new DRP for the antibody therapy, daratumumab. On the financial front, we maintained a solid cash position and reduced liabilities, including a $2 million reduction in accounts payable and accrued expenses during the quarter. These developments position us well to deliver on our upcoming clinical milestones,” said Thomas Jensen, CEO of Allarity Therapeutics. “I would also like to take the opportunity to look further back, as I have now been the CEO for just over 1.5 years. I’m struck by how quickly our Company’s situation has improved. Just a year ago, we were still working to regain compliance with Nasdaq’s listing requirements. At the same time, we had just completed the cleanup of a previously complex capitalization table—which had deterred many prospective investors—and we had committed to a more focused strategy centered solely on the advancement of stenoparib. Thanks to the dedication of our team, the guidance of our board, and the support of our shareholders, we have resolved all compliance and regulatory matters, strengthened our leadership with seasoned management professionals bringing extensive life sciences experience to our board and executive team, and are successfully executing our stenoparib-focused strategy—having launched a refined monotherapy trial protocol, which is now steadily enrolling. In addition, we have advanced the Veterans Administration–funded combination trial of stenoparib and temozolomide in small cell lung cancer, which may provide valuable insights into stenoparib’s potential beyond ovarian cancer—a potential we believe could also extend to additional cancer types. Importantly, we have maintained disciplined spending. Therefore, as we present this business update—showing solid progress in the advancement of stenoparib, continued execution of our IP strategy, expansion of our DRP platform, growth in our laboratory activities, and new collaborations with R&D partners—I’m encouraged that Allarity is on the right path toward building greater interest in stenoparib, our unique DRP® technology, and thereby the Company as a whole. I am deeply grateful for the trust and support from everyone who has made this progress possible.” Clinical and Drug Development Progress Early trial enrollment momentum: First patients dosed in the new Phase 2 clinical trial protocol, reflecting strong investigator engagement. The trial focuses on recurrent, platinum-resistant or platinum-ineligible advanced ovarian cancer patients, with the goal of optimizing dose and refining patient selection to accelerate stenoparib’s path toward regulatory approval. IBRI research collaboration: Initiated partnership with the Indiana Biosciences Research Institute to conduct advanced molecular and cellular studies clarifying the individual and combined contributions of PARP inhibition and WNT pathway modulation to stenoparib’s anti-cancer effects. This work aims to deepen mechanistic understanding, strengthen DRP®-based patient selection, and potentially expand therapeutic opportunities, including in cancers such as colorectal cancer where WNT pathway activation is common. Corporate and Strategic Developments IP portfolio expansion: Received Australian patent acceptance notice for the Stenoparib DRP® companion diagnostic. The acceptance covers 40 claims and marks a key step in Allarity’s global strategy to protect the potential international commercialization of its proprietary DRP® platform alongside the clinical development of stenoparib. Allarity Medical Laboratory growth: Signed a new licensing and laboratory services agreement with an EU-based biotech, providing access to select DRP® algorithms for breast cancer and securing laboratory services revenue commitments. DRP® platform expansion: Presented first antibody therapy–specific DRP® for daratumumab in multiple myeloma at AACR 2025, further showcasing the platform’s broad applicability across numerous cancer types and drug classes, and its ability to aid in the development of personalized, targeted therapies. Partnering outreach: Participated in Pharma Partnering Summit US (May 14–15, 2025), where CEO Thomas Jensen presented a company overview highlighting stenoparib and the DRP® companion diagnostic platform, and held one-on-one partnering meetings. Board changes: Jesper Høiland appointed to the Board of Directors, succeeding Joseph Vazzano, effective June 30, 2025. Høiland brings more than 30 years of biopharmaceutical industry experience, including senior executive roles at Ascendis Pharma and Novo Nordisk, with a proven track record in global commercialization, corporate strategy, and business development. Executive leadership changes: Jeffrey S. Ervin appointed as Chief Financial Officer effective July 1, 2025, succeeding Alexander Epshinsky. Mr. Ervin brings extensive financial and operational leadership experience in the biotechnology and healthcare sectors, having previously served as CEO of IMAC Holdings, where he led the company through its IPO and multiple strategic growth initiatives. Anticipated Clinical Milestones in 2025 Ovarian cancer trial progress: Continued enrollment in new Phase 2 ovarian cancer trial protocol, with initial data expected in 2026. SCLC combination trial launch: U.S. Veterans Administration–funded Phase 2 trial of stenoparib plus temozolomide in recurrent small cell lung cancer should open for enrollment in Q3, with patient recruitment expected to begin during H2 2025. Second Quarter 2025 Operating Results Cash Position: As of June 30, 2025, cash and cash equivalents totaled $17.8 million. The Company implemented a share repurchase plan and used $2.6 million for a stock buyback totaling 2,455,702 shares during the quarter. The Company also reduced accounts payable and accrued expenses by $2 million during the quarter. R&D Expenses: Research and Development (R&D) expenses for the quarter ended June 30, 2025, were $2.3 million, compared to $1.06 million for the quarter ended June 30, 2024. The expense is consistent with planned clinical advancement activities, including the launch of the new Phase 2 ovarian cancer trial. G&A Expenses: General and Administrative (G&A) expenses for the quarter ended June 30, 2025, were $1.8 million, compared to $2.3 million for the quarter ended June 30, 2024. Net Loss: Net loss was $2.3 million for the quarter ended June 30, 2025, compared to $1.6 million for the quarter ended June 30, 2024. For the six months ended June 30, 2025, the Company’s net loss was $5.1 million, down from $5.5 million for the six months ended June 30, 2024. 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/ 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 continued clinical development of stenoparib in ovarian cancer and small cell lung cancer, including the initiation of patient enrollment in the Phase 2 trial and a new combination study; the Company’s ability to generate data to support regulatory approval; the expansion of the DRP® platform to antibody-based therapies; the potential clinical benefit of stenoparib; and the Company’s financial position and ability to support future operations. 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, risks related to clinical development timelines, patient enrollment, trial outcomes, regulatory approval processes, the predictive performance of the DRP® platform, and the Company’s ability to secure sufficient funding or partnerships to support its programs, as well as broader risks related to the biopharmaceutical industry and general economic and market conditions. 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, and our Form 10-Q quarterly report filed with the SEC on August 15, 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: [email protected] Media Contact: Thomas Pedersen Carrotize PR & Communications +45 6062 9390 [email protected] ALLARITY THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except for share and per share data*) * All common share data has been retroactively adjusted to effect reverse stock splits in 2024 (See Note 1 in our Form 10-Q quarterly report filed with the SEC on August 15, 2025, available at the SEC’s website at www.sec.gov). ALLARITY THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) (in thousands, except for share and per share data*) * All common share data has been retroactively adjusted to effect reverse stock splits in 2024 (See Note 1 in our Form 10-Q quarterly report filed with the SEC on August 15, 2025, available at the SEC’s website at www.sec.gov). Attachment Allarity Therapeutics Press Release - Second Quarter 2025 Update
Investor releaseQuarter not tagged2025-05-10Allarity Therapeutics Provides First Quarter 2025 Update, Highlighting Continued Stenoparib Benefit and Upcoming Trial Enrollment
GlobeNewswire
Allarity Therapeutics Provides First Quarter 2025 Update, Highlighting Continued Stenoparib Benefit and Upcoming Trial Enrollment
- Stenoparib continues to demonstrate clinical benefit in heavily pre-treated ovarian cancer, with two patients remaining on treatment for more than 19 months- Initiated utilization of share repurchase program- Cash and restricted cash balance of approximately $27 million at end of Q1 2025, reinforcing financial stability TARPON SPRINGS, Fla., May 9, 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 and WNT pathway inhibitor—today reported financial results and provided an update on recent operational highlights for the first quarter ended March 31, 2025. “The start of 2025 marks an important next chapter for Allarity,” said Thomas Jensen, CEO of Allarity Therapeutics. “With enrollment about to begin in both our self-funded ovarian cancer trial and the Veterans Administration–funded combination trial in small cell lung cancer, we are focused on generating the data needed to advance stenoparib toward regulatory approval. The continued durability of response observed in ovarian cancer patients is encouraging, and we look forward to sharing updates on both trials in the months ahead.” Clinical and Drug Development Progress Durable Clinical Benefit as monotherapy dosed twice daily: Multiple patients treated with stenoparib in the ongoing Phase 2 trial for advanced ovarian cancer exceeded 30 weeks on therapy, with two patients still on treatment and receiving benefit more than 19 months, underscoring the drug’s safety profile. DRP® Platform Expansion Beyond Small Molecules: At AACR 2025, Allarity presented a novel DRP® for daratumumab in multiple myeloma, marking the Company’s first DRP developed for a targeted antibody therapy. This milestone expands the versatility of the DRP® platform, which was previously focused exclusively on small-molecule drugs. New Protocol Implemented: Building on compelling data in the ongoing phase 2 ovarian cancer trial, the Company implemented a new Phase 2 protocol focused on platinum-resistant, advanced ovarian cancer patients, with the goal of optimizing dose and refining patient selection to accelerate stenoparib more aggressively toward regulatory approval. Combination Trial Launched: Allarity announced a new Phase 2 trial evaluating stenoparib in combination with temozolomide for…Read full documentShow less
- Stenoparib continues to demonstrate clinical benefit in heavily pre-treated ovarian cancer, with two patients remaining on treatment for more than 19 months- Initiated utilization of share repurchase program- Cash and restricted cash balance of approximately $27 million at end of Q1 2025, reinforcing financial stability TARPON SPRINGS, Fla., May 9, 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 and WNT pathway inhibitor—today reported financial results and provided an update on recent operational highlights for the first quarter ended March 31, 2025. “The start of 2025 marks an important next chapter for Allarity,” said Thomas Jensen, CEO of Allarity Therapeutics. “With enrollment about to begin in both our self-funded ovarian cancer trial and the Veterans Administration–funded combination trial in small cell lung cancer, we are focused on generating the data needed to advance stenoparib toward regulatory approval. The continued durability of response observed in ovarian cancer patients is encouraging, and we look forward to sharing updates on both trials in the months ahead.” Clinical and Drug Development Progress Durable Clinical Benefit as monotherapy dosed twice daily: Multiple patients treated with stenoparib in the ongoing Phase 2 trial for advanced ovarian cancer exceeded 30 weeks on therapy, with two patients still on treatment and receiving benefit more than 19 months, underscoring the drug’s safety profile. DRP® Platform Expansion Beyond Small Molecules: At AACR 2025, Allarity presented a novel DRP® for daratumumab in multiple myeloma, marking the Company’s first DRP developed for a targeted antibody therapy. This milestone expands the versatility of the DRP® platform, which was previously focused exclusively on small-molecule drugs. New Protocol Implemented: Building on compelling data in the ongoing phase 2 ovarian cancer trial, the Company implemented a new Phase 2 protocol focused on platinum-resistant, advanced ovarian cancer patients, with the goal of optimizing dose and refining patient selection to accelerate stenoparib more aggressively toward regulatory approval. Combination Trial Launched: Allarity announced a new Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer (SCLC), fully funded by the U.S. Veterans Administration. Allarity’s material contribution is limited to supplying the necessary stenoparib drug product. This novel trial is based upon compelling therapeutic rationale for the combination and could provide a new treatment option for these patients whose options are otherwise limited. Clinical Data Presented at SGO: The Company presented updated Phase 2 clinical data at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting, demonstrating durable clinical benefit from stenoparib in heavily pre-treated ovarian cancer patients, including those with platinum-resistant, platinum-refractory, and BRCA wild-type disease. Financial Strengthening and Corporate Development Fully utilized the Company’s At-the-Market (ATM) offering program initiated in March 2024. With all capacity under the related Form S-3 now exhausted, the current ATM program has concluded. Authorized a $5 million share repurchase program, reinforcing confidence in long-term shareholder value. To date, the Company has repurchased approximately 2 million shares under the authorized buyback program. Initiated efforts to combat potential illegal short selling, engaging ShareIntel to investigate trading irregularities through enhanced market surveillance and potential legal action. Ended Q1 2025 with a cash and restricted cash balance of approximately $27 million, further reinforcing the Company’s financial stability and ability to execute on clinical development objectives. Regulatory and Compliance Resolutions Finalized settlement with the SEC following receipt of a Wells Notice in July 2024, resolving all outstanding regulatory matters related to past disclosures by prior management regarding FDA interactions on the Dovitinib NDA, which was submitted to the FDA in 2021. Had class action lawsuit dismissed, closing all related shareholder litigation and further clearing the path for Allarity to focus on clinical and corporate progress. Anticipated Clinical Milestones in 2025 New Ovarian Cancer Trial Protocol—New Protocol Enrollment: In the first half of 2025, Allarity expects to begin enrollment under a new protocol for stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The updated protocol design reflects the compelling, durable clinical benefit observed to date in platinum resistant patients. The protocol aims to provide the definitive foundation for pivotal registration trials for stenoparib in ovarian cancer. New Small Cell Lung Cancer Trial—Combination Study: Patient enrollment will initiate in Q2-Q3 2025 in this new Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer (SCLC). The trial, fully funded by the U.S. Veterans Administration, will assess the potential of this novel combination to improve outcomes in recurrent SCLC patients with extremely limited therapeutic opportunities. First Quarter 2025 Operating Results Cash Position: As of March 31, 2025, cash, cash equivalents and restricted cash totaled $27.7 million compared to $20.9 million of cash and cash receivables at December 31, 2024. R&D Expenses: Research and Development (R&D) expenses for the quarter ended March 31, 2025, were $1.4 million, compared to $2.2 million for the quarter ended March 31, 2024. G&A Expenses: General and Administrative (G&A) expenses for the quarter ended March 31, 2025, were $1.6 million, compared to $2.1 million for the quarter ended March 31, 2024. Net Loss: Net loss was $2.7 million for the quarter ended March 31, 2025, compared to $3.8 million for the quarter ended March 31, 2024. About StenoparibStenoparib 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 DiagnosticAllarity 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 TherapeuticsAllarity 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 MediaLinkedIn: https://www.linkedin.com/company/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 continued clinical development of stenoparib in ovarian cancer and small cell lung cancer, including the initiation of patient enrollment in a redesigned Phase 2 trial and a new combination study; the Company’s ability to generate data to support regulatory approval; the expansion of the DRP® platform to antibody-based therapies; the potential clinical benefit of stenoparib; and the Company’s financial position and ability to support future operations. 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, risks related to clinical development timelines, patient enrollment, trial outcomes, regulatory approval processes, the predictive performance of the DRP® platform, and the Company’s ability to secure sufficient funding or partnerships to support its programs, as well as broader risks related to the biopharmaceutical industry and general economic and market conditions. 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, and our Form 10-Q quarterly report filed with the SEC on May 9, 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: [email protected] Media Contact: Thomas Pedersen Carrotize PR & Communications +45 6062 9390 [email protected] ALLARITY THERAPEUTICS, INC.Condensed Consolidated Balance Sheets(in thousands, except for share and per share data) ALLARITY THERAPEUTICS, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(Unaudited)(in thousands, except for share and per share data) Attachment Allarity Therapeutics Provides First Quarter 2025 Update
Investor releaseQuarter not tagged2025-04-01Allarity Therapeutics Reports Full Year 2024 Financial Results and Provides a Business Update
GlobeNewswire
Allarity Therapeutics Reports Full Year 2024 Financial Results and Provides a Business Update
Cash and cash receivable balance of $20.9 million as of December 31, 2024, expected to fund operations, including clinical activities into 2027 Strengthened cash position expected to support the Company through first substantive data readout in its Phase 2 ovarian cancer trial, with enrollment scheduled to begin H1 2025 Enrollment in new Phase 2 SCLC trial to begin in Q2-Q3 2025, fully funded by the U.S. Veterans Administration At-the-Market (ATM) program, initiated in March 2024, and related Form S-3, both fully utilized and no longer active Stenoparib continues to demonstrate clinical benefit in heavily pre-treated ovarian cancer, with some patients on treatment for more than 17 months Cash balance of approximately $25 million at end of Q1 2025, reinforcing financial stability 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 ProgressIn 2024, Allarity executed a full strategic realignment to focus exclusively on the development of stenoparib, the Company’s novel dual PARP/WNT pathway inhibitor,…Read full documentShow less
Cash and cash receivable balance of $20.9 million as of December 31, 2024, expected to fund operations, including clinical activities into 2027 Strengthened cash position expected to support the Company through first substantive data readout in its Phase 2 ovarian cancer trial, with enrollment scheduled to begin H1 2025 Enrollment in new Phase 2 SCLC trial to begin in Q2-Q3 2025, fully funded by the U.S. Veterans Administration At-the-Market (ATM) program, initiated in March 2024, and related Form S-3, both fully utilized and no longer active Stenoparib continues to demonstrate clinical benefit in heavily pre-treated ovarian cancer, with some patients on treatment for more than 17 months Cash balance of approximately $25 million at end of Q1 2025, reinforcing financial stability 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 ProgressIn 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: Durable Clinical Benefit as monotherapy dosed twice daily: Multiple patients treated with stenoparib in the ongoing Phase 2 trial for advanced ovarian cancer exceeded 30 weeks on therapy, with some still on treatment and receiving benefit more than 17 months, underscoring the drug’s safety profile. New Protocol Implemented: Building on these compelling results, the Company implemented a new Phase 2 protocol narrowing in on platinum-resistant, advanced ovarian cancer patients, with the goal of optimizing dosing and refining patient selection to drive stenoparib more aggressively toward regulatory approval. Combination Trial Launched: Allarity announced a new Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer (SCLC), fully funded by the U.S. Veterans Administration. Allarity’s material contribution is limited to supplying the necessary stenoparib drug product. This marks the first combination therapy trial involving stenoparib and expands stenoparib development—based on its unique therapeutic mechanism—beyond ovarian cancer. Clinical Data Presented at SGO: The Company presented updated Phase 2 clinical data at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting, demonstrating durable clinical benefit from stenoparib in heavily pre-treated ovarian cancer patients, including those with platinum-resistant, platinum refractory, and BRCA wild-type disease. Leadership Changes Thomas Jensen appointed as permanent Chief Executive Officer, transitioning from Interim CEO to lead Allarity’s strategic and clinical advancements, drawing on his deep experience in oncology drug development and the DRP® platform. Jeremy Graff, Ph.D., appointed as President and Chief Development Officer, bringing over 25 years of oncology expertise from Eli Lilly and Company as well as numerous small cap biotechs. Jose Iglesias, M.D., appointed as Consultant Chief Medical Officer, leveraging his deep oncology experience at Lilly and Celgene to drive stenoparib’s clinical development. Alex Epshinsky appointed as Chief Financial Officer, bringing extensive biotech finance experience. Jesper Høiland, former President of Novo Nordisk U.S., appointed as Strategic Advisor, providing expertise in commercial strategy and business development. Financial Strengthening and Corporate Development Implemented cost-reduction initiatives, streamlining operations and reducing expenses to strengthen financial sustainability while prioritizing the advancement of stenoparib. Secured a European patent for the DRP® companion diagnostic for stenoparib, enhancing the international IP portfolio around its core asset. Established Allarity Medical Laboratory as a revenue-generating unit, securing agreements with multiple biotech companies for DRP® analysis and gene expression services, reducing internal lab costs, and further strengthening the Company’s position in the industry. Strengthened the cash balance to provide runway into 2027, allowing Allarity to accelerate stenoparib’s clinical development, and enabling Company operations and trials through to the first substantive data readout in its Phase 2 trial in platinum resistant, advanced ovarian cancer. Fully utilized the Company’s At-the-Market (ATM) offering program initiated in March 2024. With all capacity under the related Form S-3 now exhausted, the current ATM program is concluded. Authorized a $5 million share repurchase program, reinforcing confidence in long-term shareholder value. Initiated efforts to combat potential illegal short selling, engaging ShareIntel to investigate trading irregularities through enhanced market surveillance and potential legal action. Ended Q1 2025 with a cash balance of approximately $25 million, further reinforcing the Company’s financial stability and ability to execute on clinical development objectives. Regulatory and Compliance Resolutions Finalized settlement with the SEC, resolving all outstanding regulatory matters related to past disclosures by prior management regarding FDA interactions on the Dovitinib NDA, which was submitted to the FDA in 2021, following receipt of a Wells Notice in July 2024. Had class action lawsuit dismissed, closing all related shareholder litigation and further clearing the path for Allarity to focus on clinical and corporate progress. Secured shareholder approval and implemented 1-for-30 reverse stock split to maintain Nasdaq listing compliance. Regained compliance with Nasdaq listing requirements following a successful hearing and sustained stock price above the minimum bid threshold while maintaining the minimum shareholder equity threshold. Streamlined equity structure by consolidating to a single class of common stock to enhance transparency and shareholder value by eliminating variable-priced convertible securities, with only a negligible number of legacy warrants remaining unconverted. Anticipated Clinical Milestones in 2025 New Ovarian Cancer Trial Protocol—New Protocol Enrollment: In the first half of 2025, Allarity expects to begin enrollment under a new protocol for stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The updated protocol design, developed with input from leading gynecologic cancer experts, reflects compelling, durable clinical benefit observed to date. The protocol aims to provide the definitive foundation for pivotal registration trials for stenoparib in ovarian cancer. New Small Cell Lung Cancer Trial—VA-Funded Combination Study: Patient enrollment will initiate in Q2-Q3 2025 in this new Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer (SCLC), a combination that potentially leverages stenoparib’s unique mechanism of action to enhance the efficacy of temozolomide. Fully funded by the U.S. Veterans Administration, the trial will assess the potential of this novel combination to improve outcomes in recurrent SCLC patients, patients with extremely limited therapeutic opportunities. This study marks the first clinical evaluation of stenoparib in combination therapy, further expanding its development potential. 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 StenoparibStenoparib 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 DiagnosticAllarity 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 TherapeuticsAllarity 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 MediaLinkedIn: 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: [email protected] Media Contact: Thomas Pedersen Carrotize PR & Communications +45 6062 9390 [email protected] ALLARITY THERAPEUTICS, INC.Consolidated Balance Sheets(in thousands, except for share and per share data) ALLARITY THERAPEUTICS, INC.Consolidated Statements of Operations and Comprehensive Loss(in thousands, except for share and per share data) Attachment Allarity Therapeutics Press Release - Reports Full Year 2024 Financial Results and Provides a Business Update

