Tyme Technologies Inc (TYME) 2022 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the TYME Technologies Fiscal First Quarter 2022 Results Conference Call. (Operator Instructions) Please be advised that today's conference may be recorded. (Operator Instructions)

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

Thank you, Olivia. Welcome to TYME Technologies Fiscal First 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 us for the Q&A portion. You can also access the webcast of this call through the 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 with 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 or 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 30 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 August 10, 2021. Since then, TYME may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC 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 highlight the progress that we've made during our fiscal first quarter of 2022. It's been an extremely productive period for us. We recently completed a thorough strategic review of the company to assess opportunities and gaps and to map out a best path forward.

Our goal is to determine the most efficient and effective use of our novel technology and to identify which disease states and patient populations to focus on, all to help us ensure that our technology and resources are fully aligned to our opportunities. We completed the strategic review in Q1 and believe that TYME is now better positioned to take full advantage of the many exciting opportunities before us. As we'll discuss this morning, we have a number of promising programs underway, and we believe that we have the financial strength to advance them.

First, let me touch base on a couple of the key accomplishments of the quarter. We identified metastatic HRï±± breast cancer as a strategic clinical setting for SM-88 and we moved expeditiously to progress plans for the trial with Georgetown University. We presented interim data for the ongoing Phase II HopES Sarcoma trial at ASCO 2021 and this trial is advancing to completion. We commenced a broad biomarker initiative around SM-88 that we will believe help us optimize future development. We welcome Dr. Van Tornout as acting Chief Medical Officer; and Frank Porfido as Chief Financial Officer. We maintain financial discipline and ended the quarter with over $100 million in cash and marketable securities.

Now let's take a look at each of these programs in more detail. As I mentioned upfront, our strategic review rebuild some overlap as well as other opportunities that were not being fully captured. As a result, we took the important step of realigning our clinical pipeline. Given the strong early data with SM-88, we're now focused on these key 3 programs; 1, pancreatic cancer and second-line setting; 2, continuing to advance our work around sarcomas, where there's a high unmet need; and 3, commencing a study in breast cancer.

Let me start with our work in breast cancer. We're particularly excited about this opportunity because of the promising antitumor activity we previously observed in the study, especially in HRï±± patients. In addition, SM-88 old delivery and current tolerability profile have the potential to add another treatment option for these patients with the goal of avoiding some of the side effects of other chemotherapy treatments. This is a large patient population as HRï±± cases represent approximately 73% of the breast cancer diagnosis in the United States.

During the quarter, we announced the OASIS trial. It's an open-label Phase II trial examining SM-88 with MPS in patients with metastatic disease who will receive 2 prior hormonal therapies and failed or progressed after receiving a CDK4/6 inhibitor agent. The primary endpoint in the trial is overall response rate. Trial preparations are advancing and we expect the first patient to be enrolled this quarter. We are pleased to be partnered with Georgetown University on such an important study.

Turning now to Precision Promise trial. This is a Phase II/III randomized adaptive trial in metastatic pancreatic cancer, sponsored by the Pancreatic Cancer Action Network or PanCAN. The trial began enrollment in April of 2020 and SM-88 was the first agent included in the trial. It is being studied as a monotherapy in second-line setting. We are pleased with the progress of this trial, and PanCAN recently announced that they are currently adding an additional 5 trial sites to the original 15 sites enrolled in the trial. The sites involved in the Precision Promise trial or the top academic sites in the country for pancreatic cancer treatment. And these additions should help expedite the enrollment into this important program.

Moving on to our work in sarcomas, which are an array of different cancers, most of which have very few effective treatment options, leaving a high unmet need. We are pleased with the early efficacy signals in this area and the potential for smaller trials and expedited regulatory paths. We're, therefore, maintaining sarcomas as a strategic priority. TYME and The Joseph Ahmed Foundation continued to work with the Sarcoma Research Center in California to conduct the Phase II HopES study in sarcoma.

The interim clinical data from the trial, which we present at the 2021 ASCO General Meeting, supported the well tolerated profile of SM-88 to date and had several examples of clinical benefit and extended treatment durations that were longer than expected in this population. With 16 patients currently enrolled in the trial, we are continuing to work with the investigator to achieve the 24 predefined patient enrollment by early next year and to identify potential development path forward based on the data.

Turning now to an important takeaway from our strategic review. We identified the need to take a deeper dive around biomarker data as well as the need for additional pre-clinical studies. This is a truly exciting area of exploration for us. We announced a broad initiative to deepen our understanding of the effects of SM-88 with the goal of identifying potential biomarkers for screening or activity that could help us optimize future development for this drug.

We will be partnering with several well-known organizations, including Evotec, which is a global drug development company, and preeminent medical institutions, including Georgetown University, NYU Medical Center and the Mayo Clinic. These studies have the potential to provide valuable information to identify targeted patient populations that could have a greater response to SM-88. This type of data will help guide our future clinical development in a more efficient and effective manner.

During the quarter, we were successful with Mayo Clinic in creating and characterizing many patient-derived pancreatic cancer organoids These organoids are the foundation of the biomarker initiative. The aim will be to identify potential biomarkers for activity that can inform and hone in our clinical approach and into the future. Ultimately, the goal of precision medicine is speed and accuracy. And we believe that studying biomarkers across patient populations and indications give us the greatest chance of achieving that goal. We also initiated a broad collaboration with Evotec across a range of cancers and pre-clinical work at Georgetown focused on breast cancer models and estimate its impact on mechanisms of resistance to existing treatments.

Moving on now to the TYME team. Having the right people and the right positions is a key success factor for us. And we strengthened our team this past quarter with the additions of Dr. Van Tornout as acting Chief Medical Officer; and Frank Porfido as Chief Financial Officer. Together, they add valuable expertise to our team's finance and drug development capabilities and we look forward to their contributions.

Last, I'd like to briefly touch on an announcement we made more recently. In late July, we received notification from the United States Patent and Trademark Office and had granted additional patent claims related to our metabolic cancer metabolism technology platform. The patent involves a targeted delivery of therapeutics to cancer cells. More specifically, the concept is to fuse our patented tyrosine analogs to a second therapeutic agent in a manner that creates a fusion compound that may allow targeted delivery to cancer cells in a novel manner. This provides us with an opportunity to expand our current cancer metabolism based approach with a drug delivery platform that's aimed at delivering toxic therapies in a targeted manner with the potential to improve and offer improved safety and efficacy for a range of anticancer drugs. The program right now is largely in early pre-clinical phase and had begun to kick off and taking necessary steps to advance this technology. If it proves successful, it could be a significant asset and potential growth driver for TYME.

Looking ahead, we have many important clinical programs in various stages of development. We believe the company is well positioned, well funded and has a strong team to advance these initiatives. We continue to deepen our understanding of the potential of SM-88 to explore the role of biomarkers in advancing treatments for cancer patients and to drive forward our drug delivery efforts. We're excited about achieving our near-term milestones, including dosing the first patient and the OASIS breast cancer trial this quarter. In addition, we have a robust patent portfolio covering compositions, methods, manufacturing and use extend beyond 2032 in an innovative pipeline. Importantly, we believe a strong financial foundation will allow us to execute on these priorities.

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

Thank you, Richie, and good morning, everyone. As Richie noted, we believe we are sufficiently well capitalized to allow us to advance our pre-clinical and clinical development programs to the point where we'll be able to share data on a host of our initiatives. We project our cash balance and investments based on our current operating plan will be sufficient to fund us for at least 36 months.

We closed the first quarter of 2022 with $101.5 million in cash, cash equivalents and marketable securities. Our operational cash burn rate for the first quarter was $6 million compared to $6.7 million in Q1 2021. The decrease of $700,000 was attributable to lower spending on SM-88 clinical trials and employee-related expenses. TYME anticipates that its quarterly operational cash burn will average approximately $6 million to $8 million per quarter for the remainder of fiscal year 2022.

For the first quarter of 2022, we reported a net loss of $5.9 million or $0.03 per share. This compares to a net loss of approximately $8.8 million or $0.07 per share for the fiscal quarter of 2021. The decreased loss for the current 3-month period is due to a favorable variance of $4 million in the change in fair value of the warrant liability, offset by unfavorable variance of $2.2 million in prior year's gain on the warrant exchange and decreased operating costs of $1.1 million. The decrease in operating costs for the current 3-month period of $1.1 million primarily reflected lower ongoing trial costs and employee-related expenses.

With that, I'll open up the call for questions.

Operator, Please go ahead with instructions.

(Operator Instructions) And we have a question coming from the line of Arthur He from H.C. Wainwright.

This is Arthur in for RK. Regarding the sarcoma trial, could you give us more color on the potential data readout in next year? And what kind of data set we could expect from that update?

So right now, we're anticipating what we've communicated is that we're looking towards trial enrollment complete it sometime first half of 2022. We'll need the data to mature to some point and then we'll anticipate the data thereafter. With that being said, the endpoints are to a response rate by resist, looking at durable treatment response and tying to disease advancing by looking at duration of treatment to progression. So that's the timing of it and that's sort of data we're anticipating at that point in time.

So I had a follow-on that. So based on that data, assuming the positive, so what's your plan to for -- go for a pivotal study?

So again, we'll have to assess the data, assess what ultimately the data tells us. And then based on that, it's a matter of accelerating a path forward, identifying whether sarcoma is a specific population that we're targeting there. So we're going to be looking at how to accelerate moving forward, move quickly. As you know, this is the rare disease as we kind of look to expand this potential trial into a later kind of pivotal trial. We'll have to engage a broad group in doing so. Right now, we're focused and working with one investigator. And so there's a lot of work that needs to be done to expand the trial past that. So our goal would be is to move in an expeditious manner based on what the data is telling us and we move quickly.

(Operator Instructions) I'm showing no further questions at this time. I will now turn the call back over to Mr. Richie Cunningham for any closing remarks.

Well, thank you, again, Arthur for the question, and thank you, Olivia. Appreciate it. We're pleased with the outcomes and the priorities that emerged from our comprehensive strategic review as was discussed during this quarter. As always, our focus is on innovation to benefit cancer patients and on delivering value to our stakeholders. We appreciate your interest in the company and we look forward to keeping you updated on our progress and thank you all for your time together today and stay safe.

Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may now disconnect.