According to the World Health Organization, one in five people worldwide develops some form of cancer in their lifetime. While certain cancers respond well to treatment, others manage to “shield” themselves from targeted therapies. The micro-cap company MAIA Biotechnology is developing a drug to “trick” cancer cells, infiltrate them, and destroy them from within. As for the investment opportunity, MAIA shares are valued as having 600% upside by the investment firm Noble Capital Markets.
The story of a ‘cap’
MAIA Biotechnology was founded in 2018 by Romanian-born Vlad Vitoc, who had extensive experience leading the development of therapies for multiple cancer types at major pharmaceutical companies, such as Bayer and Novartis.
That same year, MAIA obtained a global exclusive license from the University of Texas Southwestern Medical Center for the drug THIO. This license grants MAIA full rights to develop and commercialize THIO.
THIO represents a groundbreaking approach to cancer treatment. But how exactly does it work?
Let’s start with some background. Chromosomes within each cell consist of long strands of DNA and contain hundreds of connected genes. At the ends of chromosomes, there are repeating DNA sequences called telomeres, which are often depicted in imagery like the end of a shoelace, as noted by MAIA in its 2023 financials.
In the 1930s, scientists Hermann Muller and Barbara McClintock discovered that telomeres prevent chromosomes from attaching to each other, but how they work remained unclear. In the 1950s, scientists found that during DNA replication, when one cell produces two identical copies with the same set of genetic information, the end of one strand is not copied. Logically, repeated cell divisions should result in chromosome shortening over time, but this did not occur. The reason why stayed a mystery.
A breakthrough came in the 1980s, when scientists Elizabeth Blackburn and Jack Szostak discovered unique DNA sequences at the ends of chromosomes — telomeres — that act like “caps” protecting the internal parts of chromosomes. Soon after, graduate student Carol Greider and Blackburn, her supervisor, discovered telomerase, an enzyme that prevents chromosomes from shortening. Their subsequent experiments revealed that telomeres and telomerase delay cellular aging, whereas mutations in telomerase accelerate the process.
In 2009, Blackburn, Szostak, and Greider were awarded the Nobel Prize. Oncology was among the fields that benefited from their discoveries. Unlike normal cells, cancer cells divide endlessly (causing tumors to grow) while maintaining their telomeres — thanks to telomerase. This prompted some scientists to explore the idea of treating cancer by eradicating the enzyme.
A ‘saboteur’ inside cells
MAIA’s THIO works as a “saboteur” inside cells to treat cancer.
THIO is recognized by telomerase and incorporated into the structure of the telomeres, causing them to break apart and the cancer cell DNA to unwind, leading to the tumor cell’s death, Vitoc explained in an interview with Oncology Compass.
Additionally, THIO triggers an immune response.
“An immune response [is] so effective that if you follow THIO with an immune checkpoint inhibitor, you get a complete response,” Vitoc noted.
Checkpoint inhibitors are drugs that block the signaling through immune checkpoints in a cell. While these checkpoints typically play a crucial role in the human immune system by preventing immune responses from becoming overly aggressive and by stopping the body from turning against itself, they can also hinder the immune system’s ability to fight cancer. Blocking these checkpoints, which is what inhibitors do, allows immune cells to attack cancer more effectively.
However, cancer cells can be quite adept at evading such therapies. THIO is designed to outsmart and weaken these cells, making treatment more effective, particularly when used in combination with a checkpoint inhibitor.
MAIA spotlights its chief scientific officer, Sergei Gryaznov, as a cocreator of this approach. Before joining MAIA, Gryaznov, born in the USSR, cofounded the biotech company Lynx Therapeutics and worked at Geron Corporation (where he contributed to a research program focused on a telomerase-targeting drug) before joining Janssen, a Johnson & Johnson division. It is possible that he played a key role in helping MAIA to obtain the THIO rights. As early as 2015, Gryaznov coauthored a study on the effects of 6-thio-dG (THIO) on telomerase alongside Jerry Shay from the University of Texas Southwestern Medical Center.
Better together
In 2022, MAIA commenced clinical trials of THIO in combination with a checkpoint inhibitor on patients with non-small-cell lung cancer, which accounts for 85% of all lung cancer cases.
The first two patients treated with this therapy survived 14.6 and 12.5 months after treatment, Vitoc told Oncology Compass. In the real world, the survival rate for such patients is typically just 3-4 months.
“We also believe we can improve the immunotherapy efficacy and we can restore the immunotherapy efficacy in patients who have progressed or developed resistance to prior immunotherapy,” the company wrote in its 2023 financials.
The U.S. FDA has granted THIO orphan drug designation for three indications: liver cancer, small-cell lung cancer, and glioblastoma, an aggressive brain cancer. This designation provides drugmakers with financial incentives and a seven-year market exclusivity period after regulatory approval, meaning no other company can receive approval for a drug with the same active ingredient during that period. As Vitoc pointed out, the FDA rarely grants orphan designation for multiple indications.
On January 7, MAIA announced a partnership with China-based BeiGene to test THIO in combination with BeiGene’s tislelizumab-based drug (marketed as Tevimbra) for liver cancer, colorectal cancer, and small-cell lung cancer. MAIA is now seeking FDA approval to conduct trials for each of the three indications. If approved, the combination therapy could grant MAIA access to markets worth tens of billions of dollars, according to its press release.
Following the partnership announcement, Noble Capital Markets reiterated its “buy” recommendation for MAIA stock, with a target price of $14 per share. On Thursday, January 16, shares closed at $2.02 apiece.
“We see the agreement as an important milestone in starting the trial and expanding indications for THIO. MAIA retained all development and commercial rights and is free to make additional partnerships with other companies,” Noble stated in its report.
In addition, the company is also working on next-generation small-molecule agents to modify telomeres. Out of 82 newly created compounds, two have been identified as the most promising after testing.
The MAIA business
MAIA admits that it has yet to make a profit. In 2023, its net loss came in at $19.8 million, having grown 25% year over year. For the first nine months of 2024, the company reported a net loss of $19.7 million, a 46% year-over-year increase.
For some time, MAIA relied in part on private share placements to fund itself, according to its financials. For instance, in 2022, the company sold 274,800 shares at $9 apiece for a raise of about $2.4 million.
In the summer of 2022, MAIA went public on the New York Stock Exchange, selling 2 million shares at $5 each and raising a total of $10 million before expenses. Later, its IPO underwriter exercised its option to purchase an additional 300,000 shares for $1.5 million. The company intends to use the proceeds to fund the trials of THIO and evaluate their efficacy, according to its latest quarterly report.
Since going public, MAIA has sold shares worth at least $19 million, according to company communications.
For investors
MAIA warned investors in its 2023 financials that, given its funding needs for research and development and regulatory compliance, losses will persist for several years. The company expects to make its first money when its drug goes to market. It is targeting a potential accelerated approval for its non-small-cell lung cancer treatment by the end of 2025 or in 2026, Vitok told Oncology Compass.
The company has cautioned investors that even if everything goes as planned, it may still face headwinds. THIO only works on cancer cells containing telomerase, the presence of which can be detected only through a diagnostic test. The issue, however, is that no FDA-approved tests are available yet. This could hinder THIO’s approval as the FDA generally does not approve a product if the “companion” diagnostic test is not approved as well, the company notes.
Another risk for MAIA is the rapid technological progress in the biotech sector. The industry is highly competitive, with pharmaceutical companies vying not only for a bigger market share but also for research center resources and trial participants. MAIA is likely to run into these challenges, it has warned investors.
