Everyone knows someone who has been affected by this deadly disease. And while treatment has come a long way, there is still no cure. The disease kills more than 600,000 people in the United States every year. Billions of dollars have been poured into cancer drug development for decades… but to no avail.
Oncolyze, the anti-cancer biotech startup I’m introducing to you today, has some of the most promising efficacy data that I have ever seen. Let me first explain how the cancer-fighting drug works.
In more than 25 types of cancer, a specific protein lives on the surface of cancer cells. This protein, called HDM2, is NOT present on the surface of normal, healthy cells. Oncolyze has developed a drug, called OM-301, that can immediately identify this protein. Once it identifies the protein, the drug latches on and pokes holes in the cancer cells, causing them to immediately die.
In theory, this sounds like the perfect cure to cancer. But does OM-301 actually work? And can it get to market? Let’s take a closer look.
Oncolyze is seeking an initial indication for acute myeloid leukemia (AML). This type of cancer has a mortality rate of 75% within five years of diagnosis. The FDA has far more lenient approval timelines and processes for extreme and incurable diseases like AML. So targeting AML is the quickest way to get OM-301 to market for the least amount of money.
The company will hopefully only need to conduct a 150- to 200-patient trial (far smaller than the typical trial size) to get this drug approved. For pharmaceutical startup investors, this is critically important.
Extremely Promising Animal Studies
When it comes to testing drugs on animals, the gold standard is to transplant live disease tissue directly from a human patient and inject it into mice. That is as close as you can get to testing a real patient.
Oncolyze conducted this exact study by injecting live AML tissue into mice. When the mice were given the OM-301 drug, it worked exactly as anticipated. The drug immediately killed the cancerous cells and left the healthy tissue completely unharmed. And there was absolutely zero unexpected toxicity reported.
While we can’t draw any conclusions for how the drug will react in humans, the early results are extremely promising.
The next step for Oncolyze will be to complete safety studies on mice. From there, the company can move to human clinicals (projected to take place in about a year).
Oncolyze will initially seek approval for treating AML. But here’s the kicker. This HDM2 protein that is the secret sauce to Oncolyze’s drug is found on the surface of more than 25 different forms of cancer cells. Therefore, if this drug gets approved, the company can move to new indications very quickly.
For AML alone, 20,000 patients get treated every year. The standard-of-care drug, called Venclexta, costs $100,000. Multiply those together and you get a yearly market size of $2 billion in the United States. But that is just the tip of the iceberg. If Oncolyze gets more indications (which it plans to), the market upside is significantly higher than this.
The upside is virtually unlimited. And since Oncolyze is raising at a $30 million valuation, your potential for a 10x, 100x, or even 1,000x return is very much in play.
With Great Reward Comes Great Risk
Of course, let’s not lose sight of the space that Oncolyze is in.
Pharmaceuticals are notoriously capital intensive, requiring millions of dollars to get to commercialization. Therefore, Oncolyze carries major funding risk. The company estimates it will take $15 million to get its drug through the first clinical trial. The first step in that process will be to complete safety trials in mice, which will cost an initial $5 million (with human trials costing $10 million).
Additionally, there is always a chance that another pharma company (big or small) is developing the same type of drug (in secret). However, this risk is somewhat reduced since Oncolyze has orphan drug designation, which gives the drug market protection for the specific indication of AML for seven years. There’s also a risk that the clinical trials don’t go well, which could really derail the company and its prospects.
Once-in-a-Lifetime Investment Opportunity
As startup investors, we love pharmaceutical companies because of the major world-changing upside that is baked into the opportunity. If Oncolyze can successfully commercialize this drug, more than 25 forms of cancer could potentially be CURED. Simply put, that would change the world.
Oncolyze CEO Dr. Steven Evans thinks that getting this product to market would be worthy of a Nobel Prize in Medicine. I couldn’t agree more. The company has also had multiple meetings with the FDA regarding manufacturing practices and preliminary data findings. These have all gone very well, and the company is confident it will be able to quickly bring the drug to market once approved. All the pieces are in place for Oncolyze to be successful. If the trials do happen to go poorly, the company told us that there are a number of ways to recalibrate the drug and even immediately switch focus to other indications.
Oncolyze truly represents a once-in-a-lifetime opportunity. Normally, companies like this don’t have much data at this stage and are rarely smart investments. However, Oncolyze has extremely promising animal data with absolutely zero unexpected toxicity so far. If the company gets the funding it needs, signs are pointing to this being a home run investment opportunity.
And to top it off, the company is run by an extremely competent CEO in Dr. Evans. Dr. Evans is a former cardiovascular medical doctor who has succeeded in multiple entrepreneurial endeavors. He founded a medical device company called ImaCor Medical Technologies that he brought through FDA trials and secured venture capital investments for. He also served as CEO of a company with a unique radiation treatment for solid cancers. After having a conversation with Dr. Evans, I believe he has the know-how, personality, and expertise to not only lead the company through successful FDA trials, but also continue raising the funds required to give the company enough runway to get to market.
P.S. By the way, I was so excited when I saw this company that I called up First Stage Investor founder Andy Gordon to see what he thought of it. And he loved it as much as I did.
Security type: Preferred equity
Valuation: $30 million
Minimum investment: $497.55
Where to invest: StartEngine
Deadline: March 24, 2024
How to Invest
Oncolyze is raising capital on StartEngine. If you don’t already have an account, you can sign up for one here.
Once you’re logged in, visit the Oncolyze raise page. Be sure to review the deal page and offering documents thoroughly before making an investment. When you’re ready, click the teal “invest now” button. Enter in the amount you want to invest, starting as low as $497.55, and then move through the required steps. Make sure that your investment is confirmed, and then you’re good to go.
Startup investing is inherently risky, and startup investors should expect to hold their investments without liquidity for five to 10 years. Never invest more money than you can afford to lose.