Tyme Technologies Inc (TYME) 2022 Q3 法說會逐字稿

Good day. Thank you for standing by, and welcome to the TYME Technologies' Third Fiscal Quarter 2022 Earnings Results Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions)

I would now like to hand the conference over to your speaker today, Lisa Wilson, Investor Relations. Please go ahead.

Thank you, operator. Welcome to TYME Technologies' Third Fiscal Quarter 2022 Earnings Results Call. This is Lisa Wilson of In-Site Communications, Investor Relations for TYME.

With me on today's call are Richie Cunningham, Chief Executive Officer; and Frank Porfido, Chief Financial Officer of TYME; with Dr. Jan Van Tornout, acting Chief Medical Officer; and Dr. Jonathan Eckard, Chief Business Officer, joining for the Q&A portion at the end of the call. You can also access the webcast of this call through the Investors section of the TYME website @tymeinc.com.

Before we get started, I would like to remind everyone that today's conference call will include forward-looking statements as defined by the Private Securities Litigation Reform Act. These statements include those that express a belief, expectation, projection, forecast, anticipation or intent regarding future events and the company's future performance. These forward-looking statements are based on information available to TYME's management as of today and involve risks and uncertainties, including those noted in our press release issued this morning and our filings with the Securities and Exchange Commission. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements.

TYME specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law. The archived webcast will be available for 90 days on our website, tymeinc.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on February 11, 2022. Since then, TYME may have made announcements related to the topics discussed, so please reference the company's most recent press releases and Securities and Exchange Commission filings.

And with that, I'll turn the call over to Richie Cunningham, Chief Executive Officer of TYME.

Thank you, Lisa, and welcome, everyone, and thank you for joining the call this morning. As you will hear today, TYME is a company with a diverse pipeline backed by compelling clinical data. We're also in a strong financial position, with approximately $92 million of cash and marketable securities at quarter end, which gives us the ability to execute on our current clinical initiatives as well as to assess some attractive options to build upon our pipeline.

As many of you know, the Precision Promise trial conducted by the Pancreatic Cancer Action Network, or PanCAN, with monotherapy SM-88 in second-line pancreatic cancer was discontinued due to the lack of efficacy when compared to standard of care chemotherapy. Naturally, we were incredibly disappointed to see one of our programs discontinued. And I can speak for everyone at the company that we have great compassion for those suffering from pancreatic cancer, and we're eager to provide those in need with a novel treatment.

Pancreatic cancer is recognized as a challenging setting for drug development, as reflected by the numerous prior drugs that have been unsuccessful in showing clinical benefit. Important to note, based on the information provided by PanCAN, no new trends in serious adverse events have been reported from the Precision Promise trial. And as we have reported previously, there have been minimal serious adverse events reported on SM-88. We remain committed to continuing our programs in breast cancer and sarcomas. There are many examples of drug candidates, finding success in other indications despite failing to succeed in pancreatic cancer. We expect that to be the case with SM-88, and we remain confident in its potential efficacy.

Once we get the full data set from PanCAN, we will conduct a thorough analysis. Between this data and our ongoing biomarker work, we hope to better understand if there are particular patient subsets that show benefit with SM-88. As a reminder, SM-88 has demonstrated confirmed responses in 15 different cancer types in our previous First In Human study and Compassionate Use program. For those of you who are new to TYME and our story, I will take a minute to provide background about how SM-88 works and the potential additional avenues for development.

SM-88 is an orally administered cancer metabolism-based therapy that is chemically altered to be nonfunctional for fundamental tumor cell processes, including protein synthesis. Scientific literature has highlighted that cancer cells can have a significantly higher consumption of certain amino acids compared to healthy cells, and these amino acids are required for cancer cell growth and function. We believe that SM-88, our proprietary modified dysfunctional tyrosine, is selectively consumed by cancer cells and interrupts various cell functions, including protein synthesis, autophagy and other cellular defenses that ultimately leads to oxidative stress, related apoptosis or cell death. We also believe this selective cancer uptake of nonessential amino acids is supported by the current safety profile for SM-88 that is shown minimal observed drug-related SAEs in the hundreds of patients treated to date.

Regarding the patients treated to date, in conjunction with our strategic review last year, we set about trying to better understand some of the early clinical work done on SM-88. There were 2 concurrent studies. One was the First In Human study designed to investigate the safety and tolerability of SM-88 in 30 patients over a 6-week cycle with no concurrent cancer therapies. The early results led to extended treatment for the majority of patients who would then follow to collect data on tumor responses and overall survival. In parallel with the study, there was a second related TYME supported expanded access Compassionate Use program being conducted. This program allowed for enrollment beyond the initial 30 patients, including for patients who may not have been eligible for the trial. It was through these programs that the antitumor efficacy signals were observed in 15 different cancer types, as I mentioned before.

Notably, SM-88 showed particular efficacy in breast cancer patients, including patients with hormonal positive and HER2-negative disease, which represent over 70% of the breast cancer diagnosis in the United States. In this group of patients, SM-88 had a 42% objective overall tumor response rate, which is one of the reasons for our focus in this area and our OASIS breast cancer trial. The OASIS trial is an open-label Phase II trial examining SM-88 with methoxsalen, phenytoin and sirolimus, or MPS, in patients with metastatic hormonal positive HR+/HER2- advanced breast cancer who have received 2 prior hormonal therapies and failed or progressed after receiving a CDK4/6 inhibitor agent. The OASIS study is being conducted by Georgetown University through its medical network, Medstar Health. The trial is focused on tumor response rates, and our end goal is an effective, well-tolerated oral treatment for patients before they advance the chemotherapy treatment.

We currently have 5 sites open. And as mentioned in last quarter's call, we've begun enrollment and expect a data update in the first half of 2023. We remain excited about the opportunity given the promising antitumor activity previously observed in the setting.

In addition to breast cancer, sarcoma also emerged as a strategic indication through our SM-88 studies. Sarcomas represent a range of different cancers with few effective treatment options and a high unmet medical need, which could potentially lead to an accelerated development path and approval. For this investigator-sponsored HopES study, we have partnered with the Joseph Ahmed Foundation, who is sponsoring the trial, and the Sarcoma Oncology Research Center in California. Safety and quality of life are essential to sarcoma patients, and physicians seek to extend the time until disease progression while maintaining patient quality of life.

To date, we've seen encouraging efficacy signals for our Phase II study and have found several examples of extended treatment durations, meaning patients were able to stay on SM-88 longer than what they experienced on their prior therapies as well as antitumor activity. We continue to enroll patients and plan to complete enrollment in mid-2022.

Although the company remains focused on breast cancer and sarcomas, as mentioned earlier, SM-88 has the potential to expand to other indications, and we're exploring which areas could be the most beneficial for TYME to pursue. Through our biomarker preclinical program, we aim to identify the settings where the drug produces a significant response. To achieve this objective, we have partnered with several preeminent organizations, including Georgetown University, NYU Medical Center, the Mayo Clinic and Evotec and plan to use these results generated to guide our future clinical development. We expect to report out in the data by mid-2022.

Our preclinical work also includes the development of a new tumor-targeting technology, which would combine our patented tyrosine analogs with a second therapeutic agent. We believe this fusion compound could offer a novel approach to the targeted delivery of a toxic therapeutic agent to cancer cells with an improved tolerability profile. If our technology is able to selectively deliver cancer agents in a more precise way to the tumor, we believe it could open up the door for partnering opportunities for a range of different cancer treatments.

We're also advancing our understanding of the potential utility of TYME-19, an oral synthetically produced member of the bile acid family that is being studied for the treatment of COVID-19 and possible future variants. Based on the publicly reported projections, the 2022 consensus estimate for oral COVID-19 therapeutics is expected to be over $20 billion globally. It is our belief that TYME-19 works in a manner that is not dependent on the COVID-19 spike protein to be effective. It differs from the recently approved drugs from Merck and Pfizer. As a result, if approved, it is possible that TYME-19 could end up being used in combination with other therapies to fight COVID-19 infections. We expect to have TYME-19 MOA preclinical data in the first half of 2022.

With that, I'll turn the call over to our CFO, Frank Porfido, for a detailed financial review of the quarter and our outlook. Frank?

Thank you, Richie, and good morning to everyone. As Richie noted, we believe we are well capitalized to advance our preclinical and clinical development programs. Based on our current operating plan, we project our cash balance and investments will be sufficient to fund us for approximately 36 months.

We closed the third quarter of fiscal year 2022 with $92 million in cash, cash equivalents and marketable securities. Our operational cash burn rate for the second quarter was $4.5 million compared to the third quarter of fiscal year 2021 of $5.9 million. The year-over-year decrease of $1.4 million was due to lower ongoing trial costs, primarily the discontinuation of the TYME-88-Panc third-line metastatic pancreatic cancer trial. We expect our quarterly operational cash burn for the remaining quarter of the fiscal year to be in the range of $6 million to $7 million, and this incorporates some of the savings from the Precision Promise trial that was discontinued.

For the third quarter of fiscal year 2022, we reported a net loss of $5.3 million or a loss of $0.03 per share and a net loss for the 9 months of fiscal year '22 was $16.8 million or a loss of $0.10 per share. This compares to a net loss of approximately $6.1 million or a loss of $0.05 per share for the third quarter of fiscal year 2021 and a $21.8 million loss or $0.17 per share for the first 9 months of fiscal year 2021. The year-over-year decrease in losses of $0.8 million for the 3-month period is largely due to the lower clinical trial costs, predominantly the decrease in TYME-88-Panc trial costs. The year-over-year decrease in losses of $5 million for the 9-month period is due to the favorable net variance of $2.4 million related to the noncash warrant related expenses and lower operating costs of $2.6 million, reflecting lower research and development expenses of $1.9 million due to lower ongoing trial costs and lower general and administrative expenses of $0.7 million.

I'll now turn the call back to Richie for his closing comments, and we'll then open it up for your questions. Richie?

Thanks, Frank. So before we move to take your questions, I want to first share a few final thoughts. First, we remain confident and committed in SM-88 and its potential impact in breast cancer and sarcomas. In addition, we will continue to explore the broad activity observed in the First In Human studies, together with the biomarker data as they emerge.

One of the stated goals coming out of last year's strategic review was to diversify our pipeline. You have also heard us talk about our very strong financial position. This provides us with the flexibility to consider other compelling cancer drugs under development. There are many interesting assets that are currently in need of capital, so we believe it is an opportune time for any well-funded company to consider that path, bringing in a product candidate that has a different mechanism than SM-88 could also add to the diversity of our pipeline.

As those in the biotech space are well aware, pipeline setbacks are part of the difficult process of developing new drugs. But our march towards bringing compelling novel agents that will help people in need is far from over. Our plan is to continue learning more about SM-88 through our preclinical and biomarker work, add clinical sites for the trials we're enrolling and utilize our financial strength to potentially bring in a new program or commence another one internally. The team and I remain optimistic about the potential of SM-88 as well as the other opportunities to drive value for patients and all-time stakeholders.

And with that, I'll open up the call to your questions. Operator, please.

(Operator Instructions) And at this time, I'm not showing any questions in the queue. I'd like to turn the call back over to Richie Cunningham, CEO, for any closing remarks.

Thank you, operator, and thanks, everyone, for listening in today and for your interest in TYME. We certainly look forward to updating you on our progress moving forward, and stay safe.

And this concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.