Tyme Technologies Inc (TYME) 2022 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to TYME Technologies' Second Fiscal Quarter 2022 Earnings Results Call. (Operator Instructions) As a reminder, this call is being recorded. (Operator Instructions)

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

Thank you, operator. Welcome to TYME Technologies' Second 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 this call. You can also access the webcast of this call through Investors section of the TYME website at 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 SEC. 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 at tymeinc.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on November 8, 2021. Since then, TYME may have made announcements related to the topics discussed, so please reference the company's most recent press release 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, to our presentation this morning, and thank you for the opportunity to share the progress we've made during our second fiscal quarter. It's been a very active and productive quarter as we advance our key strategic initiatives. I'll touch on some of the highlights now, and then discuss them in a bit more detail in a minute.

To start, I'm pleased to report that we've achieved a key milestone this past quarter with the first patient enrolled in the OASIS breast cancer trial. This trial is focused on tumor response rates, and our in-goal in this setting would be an effective, well-tolerated oral treatment for these patients before they advance to chemotherapy treatment. This study aligns with our mission, to deliver viable treatment options to cancer patients without compromising quality of life. And by doing so, we believe we can truly make a positive impact in their fight against cancer.

Another highlight of this past quarter is the expansion announcement of Precision Promise pancreatic cancer trial. PanCAN will be doubling the number of current sites, with an additional 5 sites that are expected to be added in early calendar year 2022 and then another 10 sites to be added by the end of calendar year 2022, doubling the original sites from 15 to 30. We believe these efforts will help accelerate the study while growing the geographic footprint to capture an even larger proportion of the treated pancreatic cancer patients in the U.S.

In addition, we have seen a meaningful increase in the rate of enrollment with our HopES sarcoma trial. This is due in large part to the internal TYME team implementing initiatives to identify potential eligible patients with this ultra-rare disease. The team is now focused on getting remaining patients enrolled in the trial, and we're targeting enrollment completion by the first half of calendar year 2022.

Importantly, we also kicked off our preclinical initiative with Evotec, who you may know is a global leader in drug development. Evotec has been asked to evaluate the potential of expanding our SM-88 platform to other indications as well as to explore the potential for the development of a novel tumor targeting technology, utilizing our patented tyrosine-based analogs. Overall, we're making steady progress, both clinically and preclinically. With $96.6 million of cash and cash equivalents and marketable securities on hand at quarter end, we believe we are well funded to advance and execute on our clinical programs and preclinical initiatives.

Now for those of you who are just getting to know TYME, overall, our approach is focused specifically and selectively in targeting cancer in a unique way. The selectivity to cancer is very important, and why we believe SM-88 has had such a favorable toxicity profile in the hundreds of patients treated to date.

Let me briefly touch on some of the early SM-88 results that support our view that this is a very promising therapy. The completed and published first-in-human study was designed to investigate the safety and tolerability of the therapy in patients over a single 6-week cycle. The study was run in 30 patients, with no concurrent cancer therapies. The early efficacy results of SM-88 ultimately led to the extended treatment with the majority of patients, which were then followed for tumor responses and overall survival.

In parallel to the study, TYME also helps support an expanded access compassionate use program. This program was run under the same Institutional Review Board, or IRB, and it was done at NewYork-Presbyterian. But it allowed patients beyond the initial 30, capturing some who might not have qualified for the first-in-human study. All patients in the expanded access program had metastatic and progressive disease.

The majority of patients in the compassionate use program received SM-88 as a monotherapy. However, there were some patients that received SM-88 in combination with other anticancer therapies, such as chemotherapy and/or radiation. But this typically meant that these patients were continuing a drug from the last regimen and due to disease progression looking for alternative treatments.

For example, in breast cancer, some patients were kept on aromatase inhibitors or hormonal agents because physicians felt stopping these could accelerate the cancer growth as these patients were progressing on current therapies upon starting SM-88 treatment.

Now key takeaways here, but that through these 2 programs, we saw confirmed responses in 15 different cancer types, including complete and partial responses in breast cancer. This, in our view, was an impressive result, which supported the rationale for current clinical development.

Now with this background, let's go through our programs in more depth. Starting with our work in breast cancer. As I mentioned at the start of the call, we've enrolled the first patient in our OASIS trial. The study is being conducted by Georgetown University at its 5 MedStar Health hospitals. MedStar Health is Georgetown's academic clinical partner, and we're excited to be collaborating with them on such an important study.

By way of background, OASIS is an open-label Phase II trial examining SM-88 with methoxsalen, phenytoin and sirolimus, or MPS, in patients with metastatic hormonal positive and HER2-negative advanced breast cancer who have received 2 prior hormonal therapies and failed or progressed after receiving a CDK4/6 inhibitor agent. The primary endpoint of the trial is overall response rate.

We are particularly excited about the opportunity because of the promising antitumor activity previously observed in this setting, especially in HR+/HER2- patients, which account for approximately 73% of the breast cancer diagnoses in the U.S. As a reminder, in this setting, we saw an impressive result with complete responses and partial responses in the 2 studies I just discussed. We believe if we can reproduce this type of result in the current OASIS trial, that it could be incredibly impactful for TYME and these patients.

Turning now to the Precision Promise trial, where oral SM-88 is being studied as a monotherapy in the second-line setting in advanced metastatic pancreatic cancer. The trial is designed as a seamless Phase II/III randomized adaptive trial that is sponsored by the Pancreatic Cancer Action Network, or PanCAN. PanCAN is a well-known organization and a globally recognized leader in advocacy for pancreatic cancer patients. Important to note, this study is considered by the FDA as a pivotal Phase III study that will evaluate the effect of oral SM-88 in all 175 patients scheduled to be treated in the study.

This adaptive randomized platform trial evaluates oral SM-88 in 2 stages. In the first stage, up to 100 patients are enrolled and treated with oral SM-88. At which point, a formal evaluation of efficacy and tolerability is determined by an independent statistical review in order to proceed to Stage 2. If the current enrollment metrics we are experiencing are sustained, we believe enrollment completion and determination of the first stage review will occur by the second half of calendar year 2022.

Now if SM-88 clears the first stage review of 100 patients, the next 75 patients enrolled would then be treated to confirm the initial efficacy and tolerability results from Stage 1. If SM-88 clears both efficacy reviews from Stage 1 and Stage 2, TYME anticipates utilizing these results to support an NDA application for approval in this setting.

So again, the Precision Promise trial began with 15 clinical sites. They include premier pancreatic cancer treatment sites across the United States. As previously mentioned, PanCAN is working to double the number of sites in the U.S. to 30 by the end of calendar year 2022, which we believe will play a significant role in helping expedite further enrollment.

Moving on to our work in sarcomas, which represent an array of different cancers with few effective treatment options and therefore, a high unmet need. As you may recall, for the HopES study, we 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 these sarcoma patients. And clinically, physicians are seeking to extend the time until disease progression, while maintaining the patient's quality of life.

The early efficacy signals for our Phase II HopES study are encouraging. So far, interim clinical data supports the well-tolerated profile of SM-88, and we found several examples of extended treatment durations in patients with advanced sarcomas and/or Ewing sarcomas, meaning these patients were able to stay on SM-88 significantly longer than prior therapies. As I stated earlier, we're targeting the completion of enrollment by the first half of calendar year 2022.

To date, the company is focused on 3 areas which we just reviewed, breast cancer, pancreatic cancer and sarcomas. But SM-88 has the potential to expand to other indications, especially as it's shown confirmed responses in 15 different cancer types during our first-in-human trial. Now through our biomarker research, we aim to identify other areas of expansion where SM-88 produces a significant preclinical efficacy response, and we're actively investing in the work to deepen our understanding of its possibilities.

For this initiative, which we believe has the potential to produce critical insights, we will be partnering with several well-known organizations and preeminent medical institutions, including Georgetown University, NYU Medical Center, the Mayo Clinic and Evotec. These studies have the potential to yield valuable and new insights to move forward on the path of precision medicine by identifying targeted subpopulations of patients. We plan to use the data to guide our future clinical development in a more effective manner. This is truly an exciting area of exploration, and we look forward to sharing our findings as information emerges.

Switching gears a bit, a quick update on other initiatives beyond our cancer therapeutic programs, which we're very excited about. We are in the early stages of attempting to develop a tumor-targeting technology, which combines our patented tyrosine analogs to a second therapeutic agent to create a fusion compound. When that occurs, we believe it could allow for a novel approach and the targeted delivery of a toxic therapeutic agent with specificity to cancer cells while showing a tolerability profile similar to what we are currently experiencing with SM-88. We'll also continue to invest preclinically to further advance our understanding of the potential utility of TYME-19, a bile acid program for the treatment of COVID-19. From an intellectual property standpoint, we have over 200 patent applications pending and granted globally, which we believe gives TYME strong coverage on our pipeline.

All in, we have a robust and diverse pipeline in various stages of development. They are protected by a robust IP estate. We will continue to drive forward our clinical programs, while deepening our understanding of the potential of SM-88. With ample cash on hand and an experienced management team in place, we believe the company is well positioned to successfully execute on our initiatives.

Now I'll turn the call over to Frank for a detailed financial review of the quarter and our outlook. Frank?

Thank you, Richie, and good morning, 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 at least 36 months.

We closed the second quarter of fiscal year 2022 with $96.6 million in cash, cash equivalents and marketable securities. Our operational cash burn rate for the second quarter was $5 million compared to $6.6 million in Q2 of fiscal year 2021. The decrease of $1.6 million was due to lower ongoing trial costs primarily due to the discontinued TYME-88-Panc third-line metastatic pancreatic cancer trial. As our initiatives ramp up, we expect our quarterly operational cash burn for the remaining 2 quarters of the fiscal year to be in the range of $6 million to $8 million.

For the second quarter of 2022, we reported a net loss of $5.6 million or a loss of $0.03 per share. And the net loss for the 6 months of 2022 was $11.5 million or a loss of $0.07 per share. This compares to a net loss of approximately $6.8 million or a loss of $0.05 per share for the second quarter of 2021 and $15.7 million or a loss of $0.12 per share for the first 6 months of 2021. The decrease in losses of $1.2 million for the current 3-month period is largely due to lower clinical trial costs, predominantly the decrease in 88-Panc costs. The decrease in losses of $4.2 million for the current 6-month period is due to the favorable net variance of $2.3 million related to noncash related expenses such as the change in fair value of the warrant liability and stock-based compensation expense as well as $1.9 million related to decreased operating costs primarily due to lower ongoing trial expenses.

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

Thanks, Frank. So as you've heard today, we have a well-defined plan and a means to execute on our plan to advance our pipeline. We're addressing large market opportunities with differentiated therapies in areas with limited or no options for patients. Our diversified pipeline continues to garner interests from premier institutions, and TYME has assembled an experienced team to develop these compounds. We strive to make a difference in the lives of people, and we endeavor to help and reward the stakeholders who give us the ability to do just that. We believe if just one of our many programs in development is successful, it will have a meaningful impact on a company of our size.

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

(Operator Instructions) There are no questions at this time. I will now turn the call back to Mr. Cunningham for closing remarks.

Thank you, Sarah. As we've shared with you today, we're making important progress in our ongoing trials as well as inroads with our preclinical work. We look forward to updating you next quarter, and we thank you for your time today. Stay safe, everyone, and thanks again.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.