New York, NY - (NewMediaWire) - May 20, 2021 - PCG Digital -- Anthony Hayes is an optimist, with good reason. The CEO of AIkido Pharmaceuticals (NASDAQ: AIKI), according to the company's Q1 report and a press release recently issued, is expecting positive results from human clinical trials of dual-action peptide receptor radionuclide therapy (PRRT) with notable insider buying in the open market displaying his strong belief in the Company's prospects.
Developed by Weill Cornell Medicine the PRRT targets the prostate-specific membrane antigen (PSMA) on prostate cancer cells. The technique involves combining an antigen (PSMA I&T) with a proprietary antibody (CONV 01), both attached to radioisotopes.
CONV 01 is unique because it can facilitate delivery of a radioactive isotope directly into tumor cells after binding to the PSMA receptor on prostate cancer cells. In layman's terms, this drug is conjugating a monoclonal antibody with a radioactive alpha particle emitter.
The delivery of both drugs is simultaneous and non-competitive, so there's no additive damage from over-lapping biodistributions. With the two molecules bound together, CONV 01 ensures internalization of both drugs, delivering a powerful radioactive payload.
Positive Results in Early Stage and Advanced Clinical Trials
Overseen by Dr. Neil Bander, Professor of Urologic Oncology at Weill Cornell Medicine, there are in-human trials ongoing; the data from one of these studies is being presented at the ASCO Conference on June 4, 2021 and is titled: "Phase I study of 225Ac-J591 for men with metastatic castration-resistant prostate cancer (mCRPC)." The Abstract was released May 19, 2021 at ASCO.org (https://meetinglibrary.asco.org/record/196409/abstract).
The small molecule (PSMA I&T) being used is nearly identical to a Novartis molecule (PSMA 617) being tested as a treatment for metastatic castration-resistant prostate cancer. Novartis recently announced positive results in Phase III clinical trials. Notably, Novartis has been acquisitive in the space over the last few years buying companies for well over $1 - 3 billion each.
Is AIKI Being Promoted?
Though the results of the Phase I-2a trial have not been released yet, the company is confident that the numbers will be good. This assumption is reinforced by the test results coming back from Novartis. Their Phase III results provide strong evidence that radioligand therapies work.
Antiviral Studies at University of Maryland
Working in collaboration with the University of Maryland Baltimore (UMB), AIkido holds exclusive licensing on a Sponsored Research Agreement (SRA) to research computer-designed pan-viral treatments. The study is fully funded and includes three patent applications.
The lead scientist on the program is Dr. Matthew B. Freeman, MD, a well-known virologist who is researching antibodies and vaccines for Influenza, SARS-CoV, MERS-CoV, and SARS-CoV-2. The study includes both novel and repurposed drugs.
The anti-viral program is a continuing mission to find treatment options for Coronavirus, Influenza, and Ebola. Researchers have already identified a SKI complex as a potential broad-spectrum antiviral target with a functional link to viral proteins.
Early results from the project are encouraging. The computer modeling in the study is focused on designing compounds to bind to SKI pockets. The screening has also identified specific compounds that inhibit the target viruses.
In addition to the SRA at UMB, Aikido has also licensed an SRA at the University of Kentucky to study solid tumor treatments using computer-designed drugs. The synthesis of the drug to use in a thirty-day study is nearly complete. Early results are promising.
Financial Outlook for 2021 and Beyond
The Q1 quarterly report from AIkido released earlier this week shows a strong balance sheet, very clean capital structure with approximately $102 million in cash and cash equivalents vs. its market cap of only about $80 million. They also have a few other investments worth an additional few million dollars that also isn't being reflected in its stock price either. There are 89.5 million shares outstanding with a cash per share equivalent of around $1.15, above its current stock price of about $1.05, receiving negative value for its pipeline and potential approaching catalysts.
The burn rate for the first quarter was $1.2 million and just $4 million in 2020, so the company has substantial runway for research and development in 2021 and beyond. The company is currently pursuing additional strategic initiatives and emerging opportunities to further diversify.
In addition to their partnership with Convergent to study synergistic dual radiotherapy for prostate cancer and studies at UMB and UK, AIkido is also sponsoring psychedelic research at Mt. Sinai and the use of psilocybin for cancer treatments with Silo Pharmaceuticals.
Though the stock price has been down recently, much of that can be attributed to market volatility and wavering consumer confidence in micro-cap biotech stocks. Viewed from an analytical perspective, AIkido is a solid company with a bright future, both in the very near term as well as longer term and is well worth paying close attention to.
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