37 unchanged sentences
We will need to increase the size of our organization and the scope of our outside vendor relationships, and we may experience difficulties in managing growth.
−Removed: As of March 26, 2025, we employed a total of 6 full-time employees and 1 part-time employee.
+Added: As of March 24, 2026, we employed a total of seven full-time employees and one part-time employee.
Our current internal departments include research and development, finance and administration.
42 unchanged sentences
If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, including damages, fines, disgorgement, imprisonment, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, contractual damages, reputational harm and the delay, reduction, termination or restructuring of our operations.
−Removed: International operations may expose us to business, regulatory, political, operational, financial, pricing and reimbursement risks associated with doing business outside of the U.S.
+Added: International operations may expose us to business, regulatory, political, operational, financial, pricing, tariffs, and reimbursement risks associated with doing business outside of the U.S.
Our business will be subject to risks associated with conducting business internationally.
3 unchanged sentences
Doing business internationally involves several risks, including but not limited to:
−Removed: multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;
+Added: multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, tariffs, permits and licenses;
failure by us to obtain and maintain regulatory approvals for the use of our products in various countries;
rejection or qualification of foreign clinical trial data by the competent authorities of other countries;
−Removed: delays or interruptions of clinical trial due to backup at ethical committees and staff shortages causing delays in processing the trials at investigator sites resulting in delayed and slow patient enrollment;
+Added: delays or interruptions of clinical trial due to backlogs at ethical committees and staff shortages causing delays in processing the trials at investigator sites resulting in delayed and slow patient enrollment;
additional potentially relevant third-party patent and other intellectual property rights;
34 unchanged sentences
Risks Related to Our Financial Position and Need for Additional Capital
−Removed: We have a limited operating history and have never generated any revenues other than from research grants and a limited number of DRP ® biomarker development agreements, which may make it difficult to evaluate the success of our business to date and to assess our future viability.
+Added: We have a limited operating history with no product revenues to date and a limited number of DRP ® biomarker development agreements, which may make it difficult to evaluate the success of our business to date and to assess our future viability.
We were incorporated as a Delaware corporation in April 2021 for the purposes of undertaking our Recapitalization Share Exchange.
1 unchanged sentence
Our predecessor, Allarity Therapeutics A/S, was organized under the laws of Denmark on September 9, 2004, and was largely focused on organizing and staffing our company, raising capital, developing our proprietary DRP ® companion diagnostics platform and acquiring the rights to, advancing the development of, our therapeutic candidate, including conducting clinical trials on our therapeutic candidate, and completing our Recapitalization Share Exchange.
−Removed: As such, we have a limited operating history and have not generated any revenues.
+Added: As such, we have a limited operating history and generated no product revenues to date.
+Added: In 2025, the company generated $0.3 million of lab revenues.
In addition, we have not yet demonstrated an ability to successfully obtain marketing approvals, manufacture drugs on a commercial scale, or conduct sales and marketing activities necessary for successful commercialization.
40 unchanged sentences
Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy.
−Removed: As of December 31, 2024, we had cash, cash equivalents and marketable securities of $19.5.
−Removed: In addition, in the first quarter of 2025, we issued and sold an aggregate of 9,719,173 shares of our common stock under our at-the-market offering program for aggregate net proceeds of $9.7 million, after deducting commissions and offering expenses payable by us.
−Removed: We believe that our existing cash, cash equivalents and marketable securities, including the net proceeds from sales of common stock under our at-the-market offering program during the first quarter of 2025, will enable us to fund our operating expenses and capital expenditure requirements at least into the second half of 2026.
+Added: As of December 31, 2025, we had cash of $14.7 million.
+Added: We believe that our existing cash will enable us to fund our operating expenses at least into the second quarter of 2027.
However, we have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us.
339 unchanged sentences
If we are found liable in a clinical trial lawsuit or a product liability lawsuit in the future, we will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.
−Removed: Risks Related to the Approval and Commercialization of Our Stenoparib
+Added: Risks Related to the Approval and Commercialization of Stenoparib
Even if we are successful in completing all preclinical studies and clinical trials, we may not be successful in commercializing stenoparib.
66 unchanged sentences
A Fast Track designation by the FDA may not lead to a faster development or regulatory review or approval process.
−Removed: We may seek Fast Track designation for stenoparib.
+Added: We achieved Fast Track designation for stenoparib.
If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical needs for this condition, the drug sponsor may apply for FDA Fast Track designation.
648 unchanged sentences
We urge our stockholders to consult with their legal and tax advisors with respect to any such legislation and the potential tax consequences of investing in our common stock.
+Added: On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act (the “OBBBA”), which, among other things, modifies the international tax regime and extends or makes permanent various provisions from the Tax Cuts and Jobs Act, including bonus depreciation and research and development expensing.
+Added: The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027.
+Added: The legislation did not have a material impact on our 2025 effective tax rate.
The development and use of artificial intelligence, or AI, presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data and could give rise to legal and/or regulatory actions, damage our reputation or otherwise materially harm our business.
17 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.