On August 15, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported its financial results for the second quarter 2023 and provided a business update (Press release, AIM ImmunoTech, AUG 15, 2023, View Source [SID1234634417]). As previously announced, the Company will host a conference call and audio webcast on Tuesday, August 15, 2023, at 8:30 AM ET (details below).
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"Over the course of the second quarter, our team continued to deliver on our timelines and made significant progress advancing Ampligen through our active human clinical studies in multiple indications. We continue to be encouraged by the growing body of positive and consistent data and believe Ampligen has the potential to be a meaningful treatment option across a number of high-value indications," commented Thomas K. Equels, Chief Executive Officer of AIM. "Our operational execution remains supported by a strong cash position, and we are steadfast in our mission to advance the clinical development of our oncology pipeline, with pancreatic cancer as our lead development program. Looking ahead to the remainder of the year, we believe we are well-positioned to achieve a number of value-driving milestones."
Recent Highlights
Ampligen identified as one of two potential therapeutics possessing modest to high potential for the treatment of post-COVID conditions out of 22 identified on-going randomized clinical trials in recent peer-reviewed publication.
Received updated data from Early Access Program (EAP) at Erasmus Medical Center which bolsters previously published data indicating that treatment with Ampligen following FOLFIRINOX was associated with improved survival rates in pancreatic cancer patients compared to matched controls of patients who did not receive Ampligen.
Commenced and completed full enrollment in the Company’s Phase 2 study evaluating Ampligen as a potential therapeutic for people with post-COVID conditions (AMP-518).
Announced the publication of pre-clinical data that suggests Ampligen has the potential to act directly on tumor cells to reduce tumor cell growth in pancreatic cancer patients with sufficient tumor levels of TLR-3, suggesting a potential biomarker to identify patients who may respond to Ampligen. The anti-tumor analysis was published in the peer-reviewed journal American Journal of Cancer Research in the paper "Rintatolimod: A potential treatment in patients with pancreatic cancer expressing Toll-like receptor 3."
Received the required approvals from the Netherlands for Erasmus Medical Center ("Erasmus MC") to begin a Phase 1b/2 study under the previously announced external sponsored collaborative clinical research agreement with AstraZeneca and Erasmus MC.
Announced the opening of an additional clinical trial site at University of Nebraska for Phase 2 study of Ampligen for the treatment of pancreatic cancer (AMP-270).
Granted patent No. 2022/01079, titled "Compositions and Methods Useful for Ebola Virus Infection" by the South African Patent and Trademark Office (CIPC).
Ampligen Expected Upcoming Pipeline Milestones
Q3 2023
Locally Advanced Pancreatic Cancer: Enroll and dose first patient in Phase 2 study
Advanced Recurrent Ovarian Cancer: Announce protocol-planned interim results
Q4 2023
Metastatic Pancreatic Cancer: Enroll and dose first patient in Phase 1b/2 study evaluating Ampligen in combination with AstraZeneca’s Imfinzi (durvalumab)
Summary of Financial Highlights for Second Quarter 2023
As of June 30, 2023, AIM reported cash, cash equivalents and marketable securities of $28.4 million. Based on management’s current expectation, the Company’s cash runway is expected to fund operations through multiple key milestones through the end of 2024.
Research and development expenses for the three months ended June 30, 2023 were $3.0 million, compared to $2.5 million for the same period in 2022.
General and administrative expenses were $2.6 million for the three months ended June 30, 2023, compared to $2.2 million for the same period 2022.
The net loss from operations for the three months ended June 30, 2023 was $4.9 million, or $0.10 per share, compared to $4.9 million, or $0.10 per share, for the three months ended June 30, 2022.
Please refer to the full 10-Q for complete details.
Conference Call and Webcast Details
As previously announced, the Company will host a quarterly conference call and live audio webcast to discuss the operational and financial results on August 15, 2023, at 8:30 AM ET.
The call will be hosted by members of AIM, CEO Thomas K. Equels and Scientific Officer Christopher McAleer, PhD. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The live webcast will be accessible on the Events page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.