What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2026-03-30 compared with 2025-03-31 · 45 added, 29 removed, 724 unchanged (9% of the section changed)

6 unchanged sentences

Historically, we have generated DRP signatures for numerous anti-cancer therapeutics and had in-licensed numerous assets for DRP-guided development, including Liposomal CisPlatin (LiPlaCis), Irofulven and dovitinib as well as the novel PARP/tankyrase inhibitor, stenoparib.

In the second half of 2023, we seated two new independent directors to our board of directors, Laura E.

Benjamin, PhD and Joseph W.

Vazzano, CPA.

Along with the chairman of the board, Gerald W.

McLaughlin, Dr.

Benjamin and Mr.

Vazzano took the decision to replace the prior CEO, Mr.

James Cullem, with Thomas H.

Jensen as interim CEO.

Jensen is a co-founder of Allarity and has extensive experience not only with the core DRP® platform technology but also with capital fund raising.

During 2024, Thomas H.

Jensen, co-founder of Allarity, was permanently installed as Chief Executive Officer due to his extensive experience not only with the core DRP® platform technology but also with capital fund raising.

Jensen was tasked with streamlining the organization and its finances.

In June 2024, Mr.

Jensen was permanently installed as our CEO.

In the second half of 2024, we added a new Chief Financial Officer, Mr.

Alexander Epshinsky, who comes to us after serving in accounting and controller roles in a series of small cap biotech companies.

Jensen re-focus our clinical development program, we also added a new President and Chief Development Officer, Jeremy R.

Graff, PhD, who was brought in with deep experience in cancer drug development, including nearly 17 years at Eli Lilly and Company and 10 more years in various C-suite roles in biotech.

During 2025, Jeffrey Ervin was hired as Chief Financial Officer.

He has a combined seven years of experience as CEO and CFO of Nasdaq- and NYSE-listed companies.

We are now singularly focused on the development of stenoparib and the parallel development of the stenoparib DRP® as a companion diagnostic.

2 unchanged sentences

Stenoparib is a novel, dual inhibitor of poly-ADP-ribose polymerase (PARP1/2) as well as tankyrases, enzymes critically important in the WNT cancer cell survival pathway.

Stenoparib is currently being explored in a phase 2 clinical trial in patients with advanced, recurrent ovarian cancer who have been pre-selected for enrollment using the stenoparib-DRP®.

Stenoparib has been explored in a phase 2 clinical trial in patients with advanced, recurrent ovarian cancer who have been pre-selected for enrollment using the stenoparib-DRP®.

Emerging clinical data from this ongoing trial in heavily pre-treated, advanced ovarian cancer patients show promising clinical benefit including a patient with a complete, confirmed response (i.e., absence of active disease by RECISTv1.1 criteria) as well as a patient with primary platinum refractory disease who stayed on therapy more than 10 months and two additional patients with ongoing stable disease still on therapy more than 30 months.

These compelling data in heavily pre-treated ovarian cancer patients have now prompted us to design a new clinical protocol, guided by key gynecologic oncology experts, to deepen and enrich the understanding of the clinical benefit from stenoparib treatment while also advancing the stenoparib-DRP® as a companion diagnostic used to select patients for stenoparib treatment.

This new trial protocol was initiated in June 2025 and is currently enrolling patients randomized into 2 dose levels:

600 mg daily given twice daily (200 mg in the morning and 400 mg in the evening) and 800 mg given twice daily (400 mg for each of the morning and evening doses).

In total, the trial aims to enroll 20 patients on each dose level for a total of 40 patients.

Importantly, in this trial, only patients with platinum resistant or platinum ineligible ovarian cancer (PROC) with no more than 1 line of chemotherapy beyond the PROC designation will be enrolled.

Moreover, all patients will be enrolled with a fresh tumor biopsy to assess the DRP® score that best aligns with extended, durable clinical benefit.

Defining the DRP® score that best predicts clinical benefit will enable the DRP®to be used as a patient selection tool in subsequent pivotal trials.

In addition to this new trial protocol in Platinum Resistant Ovarian Cancer patients, we have also begun a trial combining stenoparib with Temozolomide in relapsed Small Cell Lung Cancer (SCLC).

This randomized, biomarker-driven trial is fully funded by the US Veteran’s Administration and was opened for enrollment in January 2026.

Allarity ’ s DRP ® Companion Diagnostic Platform

38 unchanged sentences

We also control remaining composition of matter, formulation, and methods of use patent coverage on stenoparib which extends out to 2028 or 2032 depending on the relevant patents.

The patent for the stenoparib-DRP® has been granted recently in Australia and Europe and is currently under review in the United States of America.

These patents would extend the exclusivity period for stenoparib in combination with DRP®-guided patient selection beyond 2040.

Partnerships and Out-Licensing Leverage the DRP ® Platform for Other Cancer Therapeutics

4 unchanged sentences

In 2024, we signed service agreements with external biotech clients for both DRP® analysis and gene expression services.

Leveraging our gene expression and diagnostic capabilities, our laboratory will provide the services to the external clients.

We have received down payments in 2024 totaling approximately $0.2 million, are actively preparing the laboratory and required samples, and expect to start recognizing revenue in 2025.

Leveraging our gene expression and diagnostic capabilities, our laboratory generated $0.3 million of revenue in 2025.

Allarity ’ s Novel, Dual Inhibitor of PARP and Tankyrases

Our therapeutic candidate, stenoparib, is a dual inhibitor of the key DNA damage repair enzyme PARP, as well as Tankyrases, critical enzymes involved in the WNT signaling pathway commonly activated in many cancers.

DNA damage repair mechanisms are crucial to mammalian cell survival and replication.

1 unchanged sentence

Tankyrases are enzymes involved in the stabilization and maintenance of telomeres (the ends of chromosomal DNA) during cell replication.

Tankyrases and the WNT pathway also enable cancer cell survival and are commonly upregulated in advanced, chemo- and radio- resistant cancers including ovarian as well as colon and other cancers.

Tankyrases are also key activators of the WNT pathway which can enable cancer cell survival and are commonly upregulated in advanced, chemo- and radio- resistant cancers including ovarian as well as colon and other cancers.

There are multiple PARP inhibitors currently approved and used for the treatment of cancers, primarily ovarian and breast cancers but now also pancreatic and prostate cancers.

103 unchanged sentences

Consequently, Allarity must perform all of the obligations under these license agreements, including the payment to Esai pharmaceuticals of substantial development milestones and royalties on future sales in the event we receive marketing approval for stenoparib.

Stenoparib is currently in a Phase 2 clinical trial for the treatment of ovarian cancer patients who have had at least 3 prior lines of therapy.

Stenoparib has been assessed in an ongoing Phase 2 clinical trial for the treatment of ovarian cancer patients who have had at least 3 prior lines of therapy.

The trial has been running at numerous trial sites in the U.S.

3 unchanged sentences

Cohort 2 in particular has provided promising clinical efficacy data showing durable clinical benefit in multiple patients including one confirmed, complete response (by RECIST v1.1 criteria) as well as 1 platinum refractory patient remaining on the drug more than 10 months and 2 additional patients with extended stable disease continuing on treatment now beyond 30 months.

This new trial protocol was initiated in June 2025 and is currently enrolling patients randomized into 2 dose levels, 600 mg daily given twice daily (200 mg in the morning and 400 mg in the evening) and 800 mg given twice daily (400 mg for each of the morning and evening doses).

In total, the trial aims to enroll 20 patients on each dose level for a total of 40 patients.

Importantly, in this trial, only patients with platinum resistant or platinum ineligible ovarian cancer (PROC) with no more than 1 line of chemotherapy beyond the PROC designation will be enrolled.

Moreover, all patients will be enrolled with a fresh tumor biopsy to assess the DRP® score that best aligns with extended, durable clinical benefit.

Defining the DRP® score that best predicts clinical benefit will enable the DRP®to be used as a patient selection tool in subsequent pivotal trials.

In addition to this new trial protocol in Platinum Resistant Ovarian Cancer patients, we have also begun a trial combining stenoparib with Temozolomide in relapsed Small Cell Lung Cancer (SCLC).

This randomized, biomarker-driven trial is fully funded by the US Veteran’s Administration and was opened for enrollment in January 2026.

Implications of Being an Emerging Growth Company and a Smaller Reporting Company

11 unchanged sentences

Pursuant to the terms of the Recapitalization Share Exchange, our Acquisition Sub acquired substantially all of the assets and liabilities of Allarity Therapeutics A/S in exchange for shares of our common stock on December 20, 2021, and our common stock began trading on the Nasdaq Global Market on that same day.

Our principal executive offices are located at 24 School Street, 2nd Floor, Boston, MA 02108.

Our principal executive offices are located at 123 E.

Tarpon Ave., Tarpon Springs, FL 34689.

Our telephone number is (401) 426-4664, and our email address is info@allarity.com.

14 unchanged sentences

While retrospective studies guide our clinical development of our companion diagnostics, prospective clinical trials are typically required in order to receive a PMA from the FDA.

Throughout 2024, a deep dive review of our development programs, clinical progress, likelihood of clinical and regulatory success and an evaluation of commercial plausibility prompted new our management to terminate all development candidates except that of stenoparib.

Throughout 2024, a deep dive review of our development programs, clinical progress, likelihood of clinical and regulatory success and an evaluation of commercial plausibility prompted our new management to terminate all development candidates except that of stenoparib.

Not only does this streamline the focus on our most promising asset, but it also enabled critical cost saving measures.

1 unchanged sentence

These data continue to mature and have prompted us to work with Key Opinion Leaders (KOLs) in gynecologic oncology to devise and finalize a follow-on clinical trial in advanced ovarian cancer patients that will more aggressively advance stenoparib toward regulatory approval.

Accordingly, stenoparib is now enrolling in a new phase 2 trial protocol specifically targeting Platinum resistant or ineligible ovarian cancer patients at two dose levels.

A separate phase 2 study fully funded by the US Veteran’s Administration has begun enrolling patients with relapsed Small Cell Lung Cancer for treatment with stenoparib in combination with temozolomide.

Overview of Ovarian Cancer

17 unchanged sentences

Rationale for Targeting PARP in Ovarian Cancer

Ovarian Cancer (OC) is a lethal disease with a 5-year survival rate of 20-30% for advanced OC.

A large proportion of patients with OC are diagnosed at an advanced tumor stage.

The outcome after chemotherapy for advanced OC becomes poorer and poorer each time a new treatment is introduced following progression on the previous treatment.

Approximately 14,000 OC patients die each year due to disease progression.

Poly (ADP-ribose) polymerases (PARPs) are a family of DNA-dependent nuclear enzymes catalyzing the transfer of ADP-ribose moieties from cellular nicotinamide-adenine-dinucleotide (NAD+) to a variety of target proteins.

13 unchanged sentences

There is a current unmet need for treatment of patients with OC who have progressed on PARPi treatment.

Our ongoing Phase 2 study in ovarian cancer allows for enrollment of patients previously treated with a PARPi.

Our ongoing Phase 2 study in ovarian cancer, as well as our new protocol in PROC patients, allows for enrollment of patients previously treated with a PARPi.

We intend to use our Stenoparib-DRP ® to select patients from this group that will have a high likelihood of responding to our PARPi, stenoparib.

Existing PARP Inhibitors and Our Opportunity

Numerous PARP inhibitors, including Lynparza ® (laparib), Rubraca ® (rucaparib camsylate), Zejula ® (niraparib) and Talzenna ® (talazoparib tosylate) have been approved by the FDA for multiple oncology indications, including ovarian, breast, prostate, and pancreatic cancer.

Numerous PARP inhibitors, including Lynparza ® (olaparib), Rubraca ® (rucaparib camsylate), Zejula ® (niraparib) and Talzenna ® (talazoparib tosylate) have been approved by the FDA for multiple oncology indications, including ovarian, breast, prostate, and pancreatic cancer.

Sales of FDA-approved PARP inhibitors were approximately $9.0 billion in 2023 and are forecasted to be over $21.0 billion by 2031.

23 unchanged sentences

Intellectual Property

Our commercial success depends in large part on our ability to obtain and maintain patent protection in the U.S.

Our commercial success depends in large part on our ability to obtain and maintain patent protection and market exclusivity in the U.S.

and other major oncology markets and countries for our investigational products and our DRP ® companion diagnostics, to operate without being subject to the enforcement of third-party patents and proprietary rights, and to prevent others from infringing on our proprietary or intellectual property rights.

65 unchanged sentences

We paid Eisai $850,000 on August 20, 2024 and no payments are currently outstanding.

On August 2, 2024, we entered into a sixth amendment to the Eisai License Agreement with Eisai in order to (1) amend the definition of a successful completion and (2) amend the terms related to Eisai's right of termination for development.

On August 2, 2024, we entered into a sixth amendment to the Eisai License Agreement with Eisai in order to (1) amend the definition of a successful Phase 2 study completion and (2) amend the terms related to Eisai's right of termination for development.

Development Milestone Payments

194 unchanged sentences

The sponsor can request the FDA to designate the product for fast-track status any time before receiving NDA approval, but ideally no later than the pre-NDA meeting with the FDA.

In Q3 2025, the FDA granted fast-track designation to Allarity Therapeutics for stenoparib in advanced, recurrent ovarian cancers.

Any product submitted to the FDA for marketing, including under a fast-track program, may be eligible for other types of FDA programs intended to expedite development and review, such as priority review and accelerated approval.

186 unchanged sentences

Human Capital

As of December 31, 2024, we had 7 employees, 6 of whom were full-time and 1 half-time;

and most of whom were engaged in research and development activities.

As of December 31, 2025, we had eight employees;

seven of whom were full-time and one part-time.

Most employees are engaged in research and development activities.

Of our employees, the majority are in Hoersholm, Denmark.

Among our executive management team members, one is located in Sweden, one near New York, NY, and one near Tampa, FL.

Among our executive management team members, one is located in Sweden, one near Nashville, TN, and one near Tampa, FL.

None of our employees are represented by labor unions or covered by collective bargaining agreements.

2 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business