Tyme Technologies, Inc.
Q4 2019 Earnings Call Transcript

Published: 29 May 2019

[Operator:]

Good morning. And welcome to Tyme’s Fourth Quarter Fiscal 2019 Conference Call. I would like remind you this call is being recorded. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. [Operator Instructions] I would now like to turn the call over to Brian Gill, Corporate Communications and Investor Relations for Tyme. Thank you. You may begin.

[Brian Gill:]

Thank you, Operator. And welcome everyone to our fourth quarter and fiscal year 2019 conference call. The press release reporting our operating and financial results in addition to the presentation for today’s webcast can be access by going to the Investor Relations section of the corporate website at www.tymeinc.com. Joining me today with prepared remarks are Steve Hoffman, our Chief Executive Officer; Ben Taylor, our President and Chief Financial Officer; Michele Korfin, our Chief Operating officer; and our Chief Medical Officer, Dr. Giuseppe Del Priore; and our Chief Business Officer, Jonathan Eckard. As a reminder, during today’s call we will be making forward-looking statements regarding our financial and operational outlook in addition to regulatory and product development plans. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. The description of these risks can be found in our most recent 10-Q filed with the SEC. These statements speak only as of today’s date and we specifically disclaim any obligation to update or revise them. I’d now like to turn the call over to our Chief Executive Officer, Steve Hoffman.

[Steve Hoffman:]

Thank you, Brian. Good morning, everybody, and thanks for joining us. I’d like to start today’s call by showing my perspective on three key points I’m often asked about. The first is our ongoing success in clinical trials, the second is our encouraging new data from recent preclinical findings, and the third is our financial help. First, today we announced topline data from our ongoing TYME-88-Panc Phase II study, which continues to demonstrate encouraging overall survival in patients with advanced pancreatic cancer. Preliminary results from Part 1 of the 88-Panc using information available as of April 25, 2019 demonstrated the following. First, overall survival of evaluable patients is trending to be approximately double the reported survival of this patient population. Second, from patients originally reported at ASCO GI, 32% were still alive at six months or longer. Third, remarkably one of the earlier patients has just achieved over a year of survival. And fourth, in addition we learned that circulating tumor cells response correlate with longer survival. Circulating tumor cells have been correlated to prognosis and progression in other type of cancer. So it is not surprising to see as a good indicator in pancreatic as well. These findings are significantly robust and it is our plan to do everything in our power to optimize this data to benefit our pivotal trial and increase prospects of successful NDA filing with the FDA. The second point is recent preclinical data in SM-88 validates the general safety and tolerability of our cancer metabolism-based platform and reinforces our confidence in our ongoing trial in prostate, sarcoma, and of course, our planned initiation for pivotal trial for patients with third-line pancreatic cancer. This data demonstrates that SM-88 clearly works as a single agent demonstrating substantial inhibition of tumor growth. Moreover, results in the study will support our regulatory efforts, our future product development and continue to expand our strong patent portfolio. And as of April 2, 219, Tyme had approximately $25.5 million in cash and cash equivalents. This cash position ensures that our pivotal study in third-line pancreatic cancer patients can proceed as planned and we expect the pivotal Part 2 of the 88-Panc to initiate in third quarter of 2019 and complete enrollment before the end of 2020. Everyday all of us at Tyme are working on multiply the value we can create for all stakeholders to transformational research and drug development, and our passion to help cancer patients live longer better lives through better safer medicines worldwide. To begin discussion of our 2019 results, I like to turn the call over to Michele Korfin and thank everybody for their interest in Tyme. Michele?

[Michele Korfin:]

Thank you, Steve. Our focus at Tyme is developing our cancer metabolism-based therapies to provide new treatment options for patients with unmet medical needs. SM-88 has demonstrated encouraging efficacy across 15 different tumor types, including both solid tumors and hematologic malignancies. SM-88 also has demonstrated a well-tolerated safety profile. In our recently published First Human Study we’ve reported an median overall survival of almost 30 months amongst 30 patients who were treated with our oral SM-88. These patients in the study all had actively progressing metastatic cancers. Based on these encouraging results we initiated our Phase II pancreatic study. Pancreatic cancer is such a challenging diagnosis, approximately 80% of patients will unfortunately passed away within the first year of diagnosis and the estimated five-year survival for metastatic patients is only about 3%. Based on our initial data that we presented at ASCO GI, Tyme had a very informative Type C meeting with the FDA. We will now be amending our Phase II trial to be a pivotal study focused on third-line patients. Over 10,000 patients with pancreatic cancer in the U.S. reached third-line. There are not only no FDA approved therapies for these patients, but also no ASCO or NCC and recommended therapies. These patients need treatment options. We are encouraged by the initial data we’ve seen with SM-88 and advanced pancreatic cancer, and we are committed to our TYME-88-Panc study. At this time, I would like to turn the call over to the Dr. Giuseppe Del Priore, our Chief Medical Officer, who will provide the clinical update.

[Dr. Giuseppe Del Priore:]

Thank you, Michele. I would like to emphasize that the patients within Part 1 of 88-Panc are in almost unprecedented cohort of underrepresented individuals rarely are patients like these allowed into trials without severely restricting the enrollment to an unrealistic healthy representation of the real life situation reflected by the TYME-88-Panc patients. I know of no other trial where so many concessive patients died in the prescreening period before randomization. Despite the obvious difficulties these patients face enrollment completed ahead of schedule. We are using the results of Part 1 to inform the design of the upcoming pivotal trials that will be randomized and have overall survival as the primary outcome as specified in FDA guidance and reflected in our communications with the agency. As just stated, enrollment completed ahead of schedule with 49 patients consented, resulting in 39 evaluable as pre-specified in the protocol. As previously mentioned, overall survival of the evaluable patient is trending towards an approximate doubling compared to other reports in similar patient populations. For instance, estimated overall survival was two months to two-and-a-half months as presented at ASCO GI in 2019 by Manax et al. Also reported at ASCO GI in 2019 but updated here as of April 25th nine of 28 patients or 32% were still alive at least six months or longer with an early patients still alive one year after enrollment. We now have enough data to report that circulating tumor cells response correlate with longer survival. Similarly, women have emerged as significantly -- having significantly greater survival. Equally important, we have identified several screening criteria that were associated with rapidly declining prognosis and will be reflected in the design of our third-line pivotal trial. Once on SM-88 patients tolerated treatment better than nearly all other therapies I have worked with. The level of safety in this frail group of patients is especially important given the toxicity of other treatments prohibit most options for similar third-line patients. The relative lack of toxicity we believe is consistent with the theoretical mechanism of action, which also maybe the explanation for the reported lack of cross resistance and broad efficacy across multiple tumor types and spectrum of disease. We will present the details related to these observations at upcoming academic meetings. Beyond encouraging details -- beyond the encouraging updated results in the advanced pancreas cancer, we are also updating the now concluded trial of SM-88 in early PSA recurrent prostate cancer. That trial is now ready to direct hypotheses and future investigations in patients at risk for metastatic disease. You can see in the upper left figure that remarkably few patients have had any progression on imaging studies, and even more importantly, no patient develop metastasis, despite an aggressive PSA doubling time and enrollment. On the upper right, we show the intriguing universal reduction in circulating tumor cells, which are very significant in prostate cancer and has now been confirmed in 88-Panc. At the bottom of the slide, we again show the continued favorable toxicity profile so important for the treatment of tens of thousands of men facing hormone deprivation and the consequences of testosterone deprivation. And now, I’d like to turn the call back to Michele.

[Michele Korfin:]

Thank you, Giuseppe. Tyme is proud to partner with Pancreatic Cancer Action Network or PCAN for the innovative precision promise, adaptive design study. Tyme recently joined PCAN for a meeting with the FDA to finalize the precision promise protocol. The second-line arm will open in the second half of 2019. SM-88 was the first experimental therapy chosen for this second-line arm. There are over 20,000 patients with pancreatic cancer seeking second-line therapy. There been limited advances for second-line treatments. The most recently approved therapy demonstrated a 6.1-month median overall survival versus 4.2-month median for the control arm. Current second-line therapies are also very challenging from a safety standpoint. We saw encouraging SM-88 data in the second-line patients we have studied and are proud of our partnership with PCAN to advance care for these patients. Tyme is also finalizing the protocol with the FDAs for the TYME-88-Panc amended study. This is the pivotal path for SM-88 third-line. This will be a study comparing SM-88 versus an active control of physician choice, with the primary end point being overall survival. We received initial feedback from the FDA at our February Type C Meeting and the FDA confirmed the amended study design as discussed could be a registration trial. We look forward to incorporating their feedback into the final protocol. Another clinical area of focus for Tyme is sarcoma. Sarcoma’s are an orphan diseases with approximately 12,000 new cases annually in the U.S. Viewing sarcoma accounts for 30% of bone cancers in children and sadly the five-year overall survival rate for metastatic disease is only 3 -- 30%. We have had two viewing patients treated in the past with SM-88. One had a complete response and one had a partial response. Based on this initial encouraging data we were approached to study SM-88 further in sarcoma. We are proud of our partnership with the Joseph Ahmed Foundation and Dr. Sant Chawla, to initiate the SM-88 study with the first cohort focused on viewing sarcoma, with the primary endpoint of this study being overall response. At Tyme, we are committed to partnering with physicians patients and their loved ones to advanced cancer treatments through next-generation cancer metabolism-based therapies to address unmet needs and help cancer patients live longer better life. Now, let me turn the call over to Ben Taylor, our President and CFO, who will provide a financial overview and corporate update.

[Ben Taylor:]

Thank you, Michele. Total operating cash burn for the fourth quarter of fiscal 2019 was $4.2 million. The quarter was below are guided $5 million quarterly burn, primarily due to a $500,000 clinical expense that fell into the first quarter of fiscal 2020. Approximately 60% of our annual operating burn was associated with clinical research and development expenses, reflecting the continued focus of the company on advancing our pipeline. As of April 2, 2019, we had $25.5 million in cash and cash equivalents. Looking forward to fiscal 2020, we expect operational cash burn of approximately $5 million to $6 million per quarter. Historically, approximately one-third to one-half of our annual operational cash burn has been offset outside of significant financings. We believe that that is appropriate guidance for fiscal 2020 as well. Driving SM-88’s commercial availability is the core focus of the company and SM-88 is currently initiating two pivotal studies in pancreatic cancer that represent potentially rapid clinical pathways. Through our 88-Panc clinical investigators and the outstanding network of oncologists from Precision Promise, we continue to hear from KOL communities that SM-88 meets a critical unmet need in the pancreatic treatment paradigm. Michele mentioned earlier that 10,000 patients annually seek third-line therapy with no existing standard of care. But over 40,000 patients annually received first-line and 20,000 received second-line all with limited efficacy and substantial treatment related toxicity. Pancreatic cancer patients need a better option. At the same time, SM-88 has shown response in 15 different cancer types and we want to continue expanding development into new cancer indications. Our Precision Promise and sarcoma program both reflect how we have tried to balance our expanded development with capital efficiency. The Precision Promise trials save more than one-third in patient cost compared time doing a similar study internally. In addition, our partnership with JAF covers the large portion of the cost associated with the sarcoma trial. I would expect us to explore options in breast, prostate hematology and other areas that would move development forward, while also conserving capital. We focus most of our discussion on SM-88, but it’s important to note that we the pipeline waiting for the right time to move forward. We believe that the results from TYME-18 were so compelling that we needed to continue advancing it towards an IND. TYME-18 is intra-tumoral injection that leverages the same principle as SM-88, but has a completely different chemical composition. Ideally, TYME-18 could be used in connection with SM-88 to provide localized treatment for large or difficult to treat tumors, while using SM-88 to address the patient’s metastatic disease. In the first half of calendar 2019, we announce initial results on 88-Panc in our Phase II prostate study. We published the First Human Study in a peer-reviewed journal. We made significant progress with the FDA on a path to an NDA and we launched the sarcoma trial. Looking forward to the second half of 2019, we expect to continue this momentum, including data publications for both Part 1 of 88-Panc and the final results for Phase II prostate studies. Two pivotal trials are expected to initiate in the second half through Part 2 of 88-Panc and Precision Promise. We will also be diving into the mechanism of action, with results from preclinical in-vitro and in-vivo work, especially on SM-88 as a single agent in use without the conditioning agent. Lastly we’ll provide an update on TYME-18’s pathway for an IND around year end. In closing, we’re looking forward to a fiscal 2020 as a transformational year for Tyme. That ends our remarks. I would now like to turn the call over to the operator for our Q&A session.

[Operator:]

Thank you. [Operator Instructions] Our first question is from Sean Lee with H.C. Wainwright. Please proceed.

[Sean Lee:]

Hi, guys. Thank you for taking my questions. Look like we can expect a lot of progress going into the next 12 months. Regarding the upcoming pivotal part -- pivotal study, could you provide us a little more color, maybe the potential size of the study? What the competitor would be and what’s the dose of SM-88 going to be used?

[Michele Korfin:]

Yes. Hi. This is Michele and thank you for the question. So in regards to the site and comparative, so this is an amendment to the TYME-88-Panc study. So the positive news is we will be leveraging the sites. Many of the sites that participated in the Part 1, so that’s a positive, and then under the leadership of Giuseppe and [inaudible] from the clinical operation side, we also had the chance to interact with other sites through the Precision Promise program. So we may look to add on some other sites that we been interacting with through our Medical Advisory Board. So the positive news is because this is the amendment we do have the Part 1 sites that that would be ready for the amended protocol. And then in terms of comparative arm, so it will be a physician choice, so the physicians will have the option of approximately three therapies that they would be using for the third-line patient population. Now, as I mentioned in my prepared remarks, there’s unfortunately no FDA approved therapy, no ASCO or NCC and recommended therapies. So based on feedback from the medical advisors and from the FDA, we felt that the physicians choice was the most appropriate comparative. And then in terms of the dose, we will proceed -- we will be proceeding with the 920-milligram daily dose.

[Sean Lee:]

Thank you for that. And on the upcoming prostate study data in second half, what’s different from the previous updated at ASCO GU, what new stuff can we expect?

[Dr. Giuseppe Del Priore:]

This is Dr. Del Priore. I think you’ll see an increase in data points, so narrower confidence intervals. I think the message it was clear. It’s pretty dramatic. No metastases, very little progress on any imaging, and of course, the circulating tumor cells, which we’ve now confirmed in 88-Panc. So tighter intervals, I think, that’s going to lead to some wonderful collaborations and interesting follow-up studies.

[Sean Lee:]

Are there any plans right now to move that into a Phase III study as well?

[Dr. Giuseppe Del Priore:]

We’ve had a great deal of interest. You can see it reflected in our pancreas community. But also within the prostate community and we hope to have some presentations that will add to those plans at upcoming medical meetings.

[Sean Lee:]

I see. And my final question is on the newly announce TYME-18 program. Could you provide us little bit more color on that one? What it does and when can we see some maybe preclinical results from it?

[Jonathan Eckard:]

Good morning, Sean. This is Jon. So, we did put on our press release a little while ago, showing that TYME-18 and initial animal demographic models had a dramatic effect on these tumors, with about 90% of the tumors completely resolving in the animals. What we have -- what we plan on doing is gathering some more details around what is actually occurring in some of the detailed mechanisms around those observations to package them into more of a scientific presentation for appropriate scientific meeting. So, as the guidance is set, we will be providing updates on what the plans are for that program over the course of this year and we look forward to providing more details around at that time.

[Sean Lee:]

I see. Thank you for taking all of my questions.

[Operator:]

Our next question is from Arlinda Lee with Canaccord Genuity. Please proceed.

[Unidentified Analyst:]

Good morning, everyone. This is Jen James [ph] on for Arlinda. Congrats on all this progress, looking forward to it on the second half. My question, I have two questions. Can you guys tell us little bit more about the one-year survivor is Part 1 of 88-Panc and anything that’s stands out with that patient clinically?

[Dr. Giuseppe Del Priore:]

Yes. So this is Del Priore. I -- us is reflective of our population extremely poor prognosis with multiple prior lines.

[Unidentified Analyst:]

Okay.

[Dr. Giuseppe Del Priore:]

This person had actually nearly every class that’s available within pancreas cancer plus some investigational agent, plus immune oncology therapy. Despite all that she was able to have the long survival that we alluded to and we hope that it will in fact be described in more complete details either at meetings or in additional publications.

[Unidentified Analyst:]

Can you hypothesize what is the distinguishing factor between men and women survival with this disease -- treatment?

[Dr. Giuseppe Del Priore:]

So, just before I answer your question about the, Jen, I did want to add that, the patient with the longest survival is also one our CTC responders, which we think is extremely important in looking at the SM-88 mechanism of CTCs and pancreas cancer and whole host of other reasons. Now the question of gender is important, it certainly has been looked at extensively in pancreas cancer and other diseases. So we are extremely encouraged that we’ve identified a subgroup and we’re searching for the underlying mechanism. But that implies if there’s a biomarker or genotype that explains this phenotypic difference in outcomes. So I think it’s a wonderful endorsement and validation of the mechanism of actions and the benefits of SM-88 and pancreas and other ones.

[Unidentified Analyst:]

Okay. I mean just circulating to cell counts. It’s -- what is the possibility of that potentially being an clinical endpoint given the state of diagnostics today?

[Michele Korfin:]

Yeah. So, thank you for the question. So circulating tumor cells have been a very important prognostic in a number of different tumor types, we’ve seen Dr. Sharon in prostate make a comment on that. So, I know there’s active discussions with the FDA around how to further the use of circulating tumor cells as an important efficacy mark. It was -- it’s been very exciting for us to see the data with SM-88. Now we’ve seen both in our Phase II prostate study and our Phase II pancreatic study. The strong reduction in circulating tumor cells in those two different patient populations.

[Unidentified Analyst:]

Okay. That’s very helpful. Thank you very much.

[Operator:]

Ladies and gentlemen, we have reached the end of our question and answer session. I would like to turn the conference back over to management for closing remarks.

[Steve Hoffman:]

Thank you, Operator. We appreciate the attention and interest in Tyme. The management team will be available throughout the course of the day, if you have additional questions and we look forward to sharing with you our achievements and milestones throughout the course of the year. So, thanks again and look forward to our next call.

[Operator:]

Thank you. This concludes today’s conference. You may disconnect your lines at this time and thank you for your participation.