OCALA, FL / ACCESSWIRE / November 15, 2019 / AIM ImmunoTech (NYSE American:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers and immune-deficiency diseases - such as severe chronic fatigue syndrome (CFS) - provides a business update for the third quarter ended September 30, 2019, and has filed its form 10-Q with the U.S. Securities and Exchange Commission, which is available on the Company's website.
- Reported positive safety data in Phase 1 stage 4 ovarian cancer clinical study using Ampligen
- Announced the U.S. Department of Defense's (DOD) $6.42M "Breakthrough Award" to Roswell Park Comprehensive Cancer Center to fund a clinical trial to study Ampligen as a potential synergistic agent in combination with several other immunotherapies, such as pembrolizumab, in the treatment of brain-metastatic breast cancer.
- Announced a second DOD "Breakthrough Award" of $8.3 million to fund a similar Phase 2 clinical trial to study Ampligen as part of a new treatment for brain-metastatic breast cancer at the Moffitt Cancer Center
- Received clearance from the FDA for exportation of Ampligen to Argentina for the treatment of severe chronic fatigue syndrome
AIM ImmunoTech CEO Thomas K. Equels commented: "We continue to rapidly progress our clinical activities, as illustrated by a number of major upcoming expected milestones. These include:
- In as early as the end of the first quarter of 2020, publication of data from a Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer at University of Pittsburgh Medical Center.
- In as early as 11 months, interim data from a follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin, pembrolizumab, plus Ampligen at University of Pittsburgh Medical Center.
- In as early as five months, interim data from a Phase 2 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab, at Roswell Park Comprehensive Cancer Center.
- In as early as one month, first enrollment in a Phase 1 study evaluating the safety and tolerability of a combination of Ampligen and celecoxib, with or without Intron A, when given along with chemotherapy in the treatment of patients with early-stage triple negative breast cancer.
- In as early as three months, submission to the U.S. Food and Drug Administration of the protocol for two separate but parallel Phase 2 clinical trials to study Ampligen as a potential synergistic agent in combination with several other immunotherapies - including pembrolizumab and Intron A - in the treatment of brain-metastatic breast cancer (See details above in Recent Highlights).
Balance Sheet Highlights
As of September 30, 2019, AIM ImmunoTech had cash, cash equivalents and marketable securities of $11,730,000 compared with $1,825,000 as of December 31, 2019. The increase is primarily due to capital raises totaling approximately $10 million.
"The $10 million that we raised over the past few months provides us a substantial runway to support our activities while we await reportable data in the six ongoing immuno-oncology clinical trials studying Ampligen. Our role in these trials is solely to supply the Ampligen, as the trials are funded by grants from prestigious third parties directly to the clinical sites. We believe this third-party funding provides substantial validation of our platform and we look forward to providing further updates in the near-term. Meanwhile, we continue to carefully manage expenses in a way we believe will allow us to concentrate on near-term clinical goals, and as our short-term clinical trial manufacturing objectives are reached we expect to further reduce our burn rate."
Third Quarter Financial Highlights
Research and development-related expenses for the third quarter of 2019 were $1,190,000, compared with $1,595,000 million for the third quarter of 2018. Costs decreased primarily due to a general reduction in the level of Ampligen manufacturing and a decrease in clinical research costs.
General and administrative expenses for the third quarter of 2019 were $1,846,000, compared with $1,273,000 for the third quarter of 2018. The increase in G&A expenses during the current period was mainly due to an increase in stock-based compensation, an increase in public relations expenses, an increase in investment banking fees and an increase in legal fees.
The net loss from continuing operations for the third quarter of 2019 was $2,948,000, compared with $3,078,000 for the third quarter of 2018.
About AIM ImmunoTech
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For example, no assurance can be given as to whether the current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful, or yield any useful data or require additional funding. Among other things, for forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.aimimmuno.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
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AIM ImmunoTech Inc.
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SOURCE: AIM ImmunoTech Inc