I’ve followed AIM ImmunoTech (NYSEAMERICAN: AIM) for some time now and have been impressed with the idea that its drug Ampligen brings to the table. A versatile therapy, orchestrating the reprogramming of the tumor microenvironment and the body’s innate immune system to potentially fight off some of the world’s most debilitating conditions, Ampligen could be key to solving some of the world’s most pressing medical challenges.
The implications of a treatment such as this could be massive. Improved survival rates coupled with a reduced risk of toxicity are potentially possible here. Patients with cancers that come with median survival rates sitting around a year may enjoy longer lives.
The quality of life for these patients could also improve with treatment. Of course, if this is achieved, it’s an investment opportunity with the potential to create serious gains.
Quite a bit has changed since the last time I looked into the stock. The company has made impressive progress from clinical and operational standpoints, setting the stage for strong growth ahead.
AIM Will Have Several Catalysts Ahead
I’ve pointed to the fact that the robust pipeline at AIM could lead to multiple catalysts ahead. This could be no clearer after the update that the company released on October 7th, wherein the company specifically identified multiple upcoming inflection points, including two major inflection points at six months and 12 months in two Phase 2 clinical trials combining Ampligen and pembrolizumab — better known as Keytruda — for the treatment of Stage 4 metastatic triple-negative breast cancer and advanced recurrent ovarian cancer.
Here’s a list of catalystic events that we can expect to see over the next 12 months:
Any Day Now – In the press release issued early this month, AIM said that it expected a Phase 2 clinical trial of Ampligen in the treatment of early-stage prostate cancer to start in as early as two weeks from the date of the release publication. That means the start could be coming any day now. The trial is designed to assess the efficacy and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A). The combination treatment is being assessed as a potential option for prostate cancer before undergoing radical prostatectomy. While there are some internal tasks that will need to take place before the trial starts, the study has already received approval from the FDA to proceed.
About 2 Months – The company expects enrollment to start in a Phase 1 early-stage triple negative breast cancer clinical trial using Ampligen within the next 60 days. This study will combine Ampligen with celecoxib with or without Intron A as well as chemotherapy. The goal of the study is to increase survival for patients with this type of breast cancer.
About 2 Months – Results from confirmatory experiments in animals are expected in as little as two months. These experiments are assessing the combination of checkpoint blockade therapy with Ampligen as a potential treatment for pancreatic cancer. The goal is to bring this combination therapy into Phase 2 studies.
About 4 Months – In about 4 months, AIM is expecting that a team at the University of Pittsburgh Medical Center (UPMC) will publish interim data from a Phase 1 / 2 study of intraperitoneal chemo-immunotherapy — and Ampligen — in advanced recurrent ovarian cancer.
About 6 Months – Ampligen is currently in the middle of a Phase 2 clinical trial as a potential option for patients with Stage 4 metastatic triple-negative breast cancer. The goal of the trial is to assess potential synergistic effect when combining Ampligen and pembrolizumab. AIM said that it expects for this data to be available in as early as six months.
About 6 Months – AIM also expects to receive and provide interim data from a Phase 2a study in about 6 months. This study is assessing the combination of Ampligen, interferon Alfa-2b and celecoxib as a potential option for colorectal cancer metastatic to the liver.
About 12 Months – The company also said that we could see another Phase 2 data readout in as little as 12 months, this one assessing the synergistic effect when combining Ampligen and pembrolizumab in patients with advanced recurrent ovarian cancer.
In the world of clinical-stage biotechnology investing, the name of the game is catalystic events. These stocks can see tremendous gains when patient enrollments, data releases, trial initiations and other events of the like take place.
At this stage of the game, it’s not common to see companies outlining times to watch for seven specific catalysts within a 12-month period. This, my friends, is exciting news.
Other Potential Catalysts
The events listed above aren’t likely to be the only catalysts that we see over the next 12 months. The company also outlined several clinical trials that may begin in 2019 and 2020. These trials are all dependent on funding, which we’ll talk about in a bit:
Brain-Metastatic Breast Cancer – A Phase 2 study in brain-metastatic breast cancer. The trial will combine distinct immunotherapy approaches, including Ampligen. Both Roswell Park Comprehensive Cancer Center and Moffitt Cancer Center received a combined approximately $15 million in “Breakthrough Awards” from the U.S. Department of Defense (DOD) to fund the two separate but parallel clinical trials.
Stage 4 Refractory Metastatic Colorectal Carcinoma – AIM is actively working to generate grant funding for a Phase 2 clinical study of Ampligen plus pembrolizumab in Stage 4 refractory metastatic colorectal carcinoma. The study will enroll up to 25 patients and will take place at Roswell Park Comprehensive Cancer Center.
Stage 4 Urothelial, Melanoma and Renal Cell Carcinoma – The company is also looking forward to a potential Phase 2 study of Ampligen plus checkpoint blockade therapy. The goal of the trial will be to improve outcomes for patients with advanced-stage urothelial cancer, melanoma or renal cell carcinoma. The protocol is currently being designed.
Non-Small Cell Lung Cancer – Roswell Park is currently exploring a pilot study to establish proof of concept. The goal is to assess chemotherapy in combination with Ampligen plus checkpoint blockade therapy as a first-line option for non-small cell lung cancer.
Important Financial Milestones Achieved
Funding is a constant concern in the clinical-stage biotechnology space, where in most cases it costs tens of millions of dollars to bring a new drug to market. Sometimes, the cost can be higher! Nonetheless, due to the achievement of recent financial milestones, this may not be a limiting factor for AIM in the short term.
The company has been able to raise substantial funding as investors and grantors see value in Ampligen. In fact, AIM has raised about $10 million from the public markets. Combined with the approximately $15 million in DOD funding granted directly to the clinical sites conducting the two brain-metastatic breast cancer studies, AIM believes it has the funding support it needs to get through the catalysts mentioned above.
In the company’s October 7 quarterly oncology update, AIM CEO Thomas K. Equels had the following to offer:
“The $10 million that we raised over the past few months is critical for our ongoing research and development, as it provides us with a financial cushion while we await reportable data in our immuno-oncology clinical trials — trials that are already funded by grants to the research institutions from prestigious third parties. This type of third-party support mitigates our risk in these projects, as the grantors directly fund the research institutions and our principal obligation is to supply the Ampligen.
I am pleased to report that, as of the end of the third quarter, we will report approximately $12.5 million of cash on hand. At the same time, we are carefully managing our expenses in a way we believe will allow us to clearly focus on near-term clinical goals, as outlined below, and as our short-term clinical trial manufacturing objectives are reached we will strive to reduce our burn rate.”
Expanded Access Program
Ampligen has been the subject of an Expanded Access Program (EAP) as a standalone treatment in pancreatic cancer for some time. The program is taking place in the Netherlands at Erasmus University Medical Center.
Patients must have undergone treatment with either FOLFIRINOX or post-Whipple procedure prior to acceptance in the program. Patients also must be 18 years or older to take part in the EAP.
The EAP was initially approved for extremely advanced cases of metastatic or locally advanced pancreatic carcinoma. However, the program has been expanded with an approval for all pancreatic cancer, regardless of stage.
It is expected that the Investigators will publish data from the first two years of the program within the first half of 2020.
Approval for Shipment to Argentina
In other news, AIM said that it recently received great news from the FDA. The regulatory body has cleared the export of Ampligen to Argentina.
Ampligen was previously approved for commercial sale as a treatment for ME/CFS in Argentina. This is the first time an approval has taken place for this indication ever, around the world! However, commercialization has been on hold as the FDA needed to approve the export of the drug.
This is great news as with this approval, AIM has more to offer a potential partner that is interested in teaming up to bring Ampligen to Argentina. As such, this could lead to a large catalyst ahead.
The Market Potential Here Is Incredible
Should Ampligen break into any one of its oncology indications in the United States, the market opportunity would be a very large one. AIM is actively seeking a co-development or out-licensing deal with an established Big Pharma company, and this potential partner would be primed to tap into an overall oncology drug market that is expected to grow to be worth about $176.51 billion by the year 2025.
The vast market offers up several subcategories with tremendous opportunity. Hard-to-treat cancers are at the top of this list. Essentially, if Ampligen were to receive approval for just one of these indications, to a big pharma final developer it could mean potentially hundreds of millions of dollars in revenue per year. With a market cap in the sub-$5 million range, this is an incredible growth opportunity!
The Bottom Line
The bottom line here is simple. If you have put your faith into AIM and hoped that you would see strong progress over the past few months, you have not been let down. The company has been aggressively working to achieve key developmental and financial milestones.
Today’s AIM is a much different company than it was even a few months ago. Investors can look forward to several catalysts that we now KNOW are coming. Moreover, the short-term threat of further dilution in an effort to raise funds is behind AIM as it works through these catalysts.
All in all, AIM is becoming an opportunity that’s hard to ignore
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