TYME Technologies Inc. has become one of the top-trading penny stocks on the market over the past five trading days. On July 26th, they dropped a press release that covered a new patent claim. We will touch more on their patented technology later. First, I’d like to start off with a summary of their company. Then, we can dive deeper into their revolutionary technology and finish with a look at any available financial information available to the public.
TYME Tech Overview
TYME Technologies is committed to delivering Cancer Metabolism Based Therapies (CMBTs™) for patients with advanced, difficult-to-treat cancers. Doing all of this while reducing the burden on our healthcare system is a tall task to take on. They are an emerging biotech company developing cancer therapeutics. These therapeutics are broadly effective across tumor types and have low toxicity profiles. These low toxicity levels minimize the impact that cancer patients go through when recovering from their disease. Their approach takes advantage of a cancer cell’s innate metabolic weaknesses to compromise its defenses. Their therapy causes oxidative stress on cancer cells and higher exposure to the body’s natural immune system. This process can lead to a high level of cancer cell death in patients. Additionally, they believe their pipeline offers hope to patients in the long-term management of different types of cancers.
“This is a next generation approach that is designed to both control cancer and allow patients to have a more normal quality of life.”
Ben Taylor, a past CFO of Tyme Technologies Inc.
The company has forward-looking statements that go as far as 2032. They currently have 150 patents pending. Additionally, many that have already been granted. This shows how they are keeping a long-term focus. The company will look to further develop their proprietary technology into the future.
Scientific Solutions Without Compromise
SM-88 is TYME Technologies Inc.’s main “product”. It is the company’s patented Cancer Metabolism-Based Therapy. The technology behind SM-88 is a modified proprietary tyrosine derivative. It is built to interrupt the cancer cells’ metabolic processes. The team hypothesizes by breaking down the cells’ main defenses will eventually lead to cell death. TYME representatives are also eager to combine their approach with other innovative treatments. Now, here is an overview of how it works: cancer cells need amino acids to thrive and the metabolic approach makes one of those amino acids dysfunctional. The cancer cells don’t recognize the metabolic treatment as being extraordinary, so they don’t try to fight it. The cancer cells have one less amino acid to feed off. Thus, the treatment causes the cancer cells to die from within as it loses one of its necessary amino acids.
Recent Investor Presentation and Future Outlook
In their most recent investor presentation, Tyme Technologies Inc.’s executives share how their SM-88 therapy allows for combination with other therapies. Due to its favorable safety profile, well-established chemotherapies and new procedures like immuno-oncology allow for this potential. The team seems to be focusing on pancreatic and breast cancers, as well as soft tissue sarcomas. They were able to come to this plan by looking at past data markers, finding high levels of unmet needs, and attractive timeline to validation.
The company believes that if they are able to offer their SM-88 therapy earlier in the 2nd-Line pancreatic cancer metastatic phase, then it will offer the highest cost-benefit for itself and its patients.
Upcoming Trial Milestones
As far as timelines go, TYME Technologies Inc. plans to have its first patient enrolled in the OASIS Breast trial by Q3 2021. Then, by Q2 2022, they aim to have the sarcoma trial enrollment completed and a part 1 pancreatic cancer data update available. Finally, by Q3 of 2022 they plan to have the Precision Promise pancreatic cancer 2nd-line graduation decision.
Overall, the company seems to have a robust pipeline of new therapies they’ve created. Plus, they remain focused on understanding the full potential of SM-88. They strive to learn new ways to apply this breakthrough technology. Over time, they may look to find new partners to offer their technology together.
To be a pessimist for a minute here, there is still much discovery the company needs to go through. This all leads to a series of headwinds that many biotech companies find themselves going through.
Clinical Trial Data
So far, clinical trial data has shown positive responses among 15 different cancers. Some of these cancers include pancreatic, lung, breast, prostate, and sarcoma. Keeping patient safety in mind, they have had “minimal Grade 3 or higher adverse events”. However, a Grade 3 adverse event can be a severe and undesirable adverse event. This can include significant symptoms requiring hospitalization or invasive intervention, among other things. Moving on, it will be important to see how patients continue to respond to this type of therapy.
As far as clinical trials go, SM-88 has three different clinical trials underway. Two that are in Phase 2(OASIS – focused on breast cancers, HoPES – focused on metastatic sarcomas) and one currently in Phase 2/3 (Precision Promise – focused on pancreatic cancers). They also have three other preclinical trials underway. They cover solid tumors, multiple different oncology indications, and COVID-19.
Leadership Review
Currently, the CEO of Tyme Technologies Inc. is Richie Cunningham. Richie brings an in-depth understanding of maximizing therapeutic lifecycles and enhancing outcomes in biotech business models. Most recently, Richie was the CEO at Icagen, where he successfully negotiated multiple licensing deals, as well as led two acquisitions. Richie’s experience with M&A, licensing structures, and history in the industry could prove valuable to TYME’s future success.
Their Chief Science Officer is Steven Hoffman. Steven co-founded TYME and has over 30 years of experience in biochemistry and physics. He has been the lead author on over 40 patents and has focused on oncology and metabolic syndrome with biopharmaceuticals for the last decade.
Finally, the Chief Financial Officer, Frank Porfido has over 25 years of strategic financial leadership under his belt. He spent over 15 years with Novartis and became responsible for developing its $15 billion global strategic plan. Before joining TYME Technologies Inc., he worked as the VP of Finance for UroGen Pharma Inc. While there, he played a significant role in the launch of the company’s first commercial project.
Although there are plenty more leaders in the company, these three men provide vast experience and past success in related markets. Although past success does not determine the future, this certainly is something that early-stage investors like to see.
Most Up-to-Date SEC Filings
In their most recent investor presentation, the team also shared their overall financial picture. They had more than $107 million available in cash, and an expected cash burn of $24-$32 million. TYME is set to have an expected cash balance of $75-$83 million come March 31, 2022. For those wondering, TYME has their fiscal year end set for March 31st.
In their most recent 10-K, we can see that much of their cash accumulation came from proceeds from registered stock offerings, and exercising of stock options. As the company continues to be at $0 revenue, it will be imperative for their Phase 2 and 3 trials to prove valuable for future commercialization of their products. However, based on their current cash burn rate the company could last 2-3 years past March, 2022 with their current cash reserves.
Review
TYME Technologies is dedicated to allowing a better quality of life to those suffering from advanced cancers. They aim to change the way therapies are offered to patients and leverage a biotechnology that fights with the immune system, not against it. Being able to continue to leverage R&D for the coming years without financial burden will allow them to continue to build potential for a pipeline if their trials can prove to show positive results. The direct markets they aim to take on have an almost $50 billion valuation. If they are able to take 1% of the market, that could yield ~$500 million in revenue per year. With industry average P/S at about 5x, that could bring a $2.5 billion valuation. With a current market cap of less than $200 million today, July 30th, 2021, a speculative investment is worth doing some more research into.
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Do Your Own Research
*Disclaimer: The opinions expressed in the Blog are for general informational purposes only. They are not intended to provide specific advice or recommendations for any individual or on any specific security or investment product. Our goal is to provide education about the financial industry.
Sources
https://www.linkedin.com/company/tymeinc/
https://s22.q4cdn.com/265040820/files/doc_presentations/2021/06/TYME_Q4FY21_jun10_rs-compressed.pdf
https://d18rn0p25nwr6d.cloudfront.net/CIK-0001537917/8d2cf959-8dca-4c55-a075-7c8654836d9d.pdf
