Release Date: August 16, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Ampligen shows potential in oncology, particularly in combination with dendritic cell vaccines and checkpoint inhibitors.
- Positive preclinical data published in a peer-reviewed journal, indicating slowed tumor growth and improved survival.
- Progress in clinical trials for pancreatic and ovarian cancer, with some patients showing stable disease.
- Commitment to transparency through the CEO Corner program, providing stakeholders with regular updates.
- Sufficient cash position of $10.1 million to fund operations through multiple key milestones.
Negative Points
- Progress in clinical trials for metastatic pancreas cancer is slow due to the complexity of the disease.
- High recurrence rate in ovarian cancer, with approximately 80% for Stages 3 and 4 patients.
- General and administrative expenses increased to $6.4 million for the first half of 2024, compared to $4.8 million in the same period of 2023.
- Research and development expenses decreased, which may indicate slower progress in some areas.
- Dependence on collaborations with big pharma companies, which could pose risks if partnerships do not yield expected results.
Q & A Highlights
Q: Can you provide an update on the DURIPANC trial for metastatic pancreas cancer?
A: Chris McAleer, Scientific Officer: The DURIPANC trial is a Phase 1/2 study combining Ampligen with AstraZeneca's durvalumab. The first cohort completed the safety evaluation, and the medical review committee approved moving to the next dosing level. The second grouping also passed the safety evaluation, and additional patients are being enrolled at the highest dose level. Preliminary data from the lowest dose level show stable disease in two patients and minor progression in one, with two patients still showing stable disease.
Q: What progress has been made in the locally advanced pancreas cancer trial?
A: Chris McAleer, Scientific Officer: We received the FDA's written response to our Type D meeting package in June, agreeing in principle with our proposed changes to the inclusion criteria and treatment arms. We are finalizing protocol changes and believe this new protocol will allow for greater site and patient recruitment in the US.
Q: How is the advanced recurrent ovarian cancer trial progressing?
A: Chris McAleer, Scientific Officer: The trial using Ampligen plus pembrolizumab and cisplatin has shown a clinical benefit rate of over 60%. Dr. Robert Edwards at the University of Pittsburgh is impressed with the immune changes to the tumor microenvironment. The trial is wrapping up enrollment, and manuscripts highlighting the data are expected by the end of the year.
Q: What are the financial highlights for AIM ImmunoTech?
A: Thomas Equels, CEO: As of June 30, 2024, our cash, cash equivalents, and marketable securities are $10.1 million. Research and development expenses for the three and six months ending June 30, 2024, were $1.1 million and $3.1 million, respectively. General and administrative expenses for the same periods were $2.6 million and $6.4 million, respectively.
Q: Can you discuss the progress of Ampligen for post-COVID fatigue?
A: Chris McAleer, Scientific Officer: We have identified certain inclusion criteria to delineate high responders and are awaiting biomarker data expected in mid-September. We are working with patient advocacy groups to design the subsequent trial and aim to submit a preliminary regulatory package to the FDA in Q4.
Q: What are the future steps for the advanced recurrent ovarian cancer trial?
A: Chris McAleer, Scientific Officer: Future steps include wrapping up enrollment and planning subsequent trials. We are eager to see follow-up data on the duration of response, as ovarian cancer has a high recurrence rate. Preliminary data from the Phase 2 study combining Ampligen with cisplatin and dendritic cell vaccine is also anticipated.
Q: How does AIM ImmunoTech plan to maintain transparency with stakeholders?
A: Thomas Equels, CEO: We are committed to transparency and continue to be active on the CEO Corner program, providing information and access. We invite stakeholders to sign up for alerts and submit topics of interest on our website.
Q: What collaborations does AIM ImmunoTech have with big pharma companies?
A: Thomas Equels, CEO: We are collaborating with Merck on the advanced recurrent ovarian cancer study at the University of Pittsburgh and with AstraZeneca on the DURIPANC study. These collaborations are crucial for advancing our clinical programs.
Q: What is the significance of the recent data on Ampligen in oncology?
A: Thomas Equels, CEO: Recent data show that Ampligen, in combination with dendritic cell vaccines and checkpoint inhibitors, slowed tumor growth and improved survival in preclinical models. This data, published in the peer-reviewed journal Vaccines, gives us confidence as we advance our clinical oncology programs.
Q: What are the key milestones AIM ImmunoTech is focusing on?
A: Thomas Equels, CEO: We are focusing on advancing our clinical trials, securing regulatory approvals, and maintaining financial stability to fund operations through multiple key milestones. We believe Ampligen has the potential to unlock tremendous value for all stakeholders.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
