Allarity Therapeutics

Allarity, Inc., is a clinical-stage precision medicine company committed to advancing a pipeline of in-licensed oncology therapeutics for patients with difficult-to-treat cancers. Currently one of its therapies, 2X-121/stenoparib, a differentiated, dual PARP and WNT pathway inhibitor, has advanced into clinical testing (Phase 2) for treatment of advanced recurrent, platinum-resistant or platinum-ineligible ovarian cancer and for treatment of recurrent small cell lung cancer (SCLC) in combination with temozolomide.

Access Through Clinical Trials:
The primary option for patients to get access to investigational products is to participate in a clinical trial. Patients and physicians can learn more information about Allarity’s ovarian cancer clinical trial by visiting https://clinicaltrials.gov/study/NCT03878849.

Individual Patient Expanded Access Applications:
At this time, Allarity does not have an expanded access (EA) (also known as compassionate use) program; however, it will consider providing 2X-121/ stenoparib for individual patients on a case-by-case basis. This opportunity applies only to patients with serious or life-threatening conditions who are unable to participate in a clinical trial and for whom there are no comparable or satisfactory alternative therapy options.

Evaluation Criteria and Request Process:
In determining whether an Individual Patient EA is appropriate outside of a clinical trial, Allarity will consider many factors, including:
• the strength of available efficacy and safety data;
• the patient’s medical condition and history;
• the benefit-risk profile of our drug in relation to the patient’s situation;
• the potential impact on the clinical development program; and
• the ability and willingness of the patient’s physician to sponsor the treatment application.

Requests for single-patient expanded access must be made by the patient’s physician. Allarity may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting.

For Patients:
If you are a patient, you should discuss your situation with your treating physician. Your physician can make a request on your behalf.

For Physicians:
If you are physician and believe your patient may be a candidate for single-patient access to 2X-121/ stenoparib, please submit your request to expandedaccess@amarexcro.com. We regularly monitor this mailbox and will use our best efforts to respond to your request within 5 business days after receiving