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spk00: Ladies and gentlemen, thank you for standing by, and welcome to the Time Technologies Fiscal First Quarter 2022 Results Conference Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press the star, then the one key on your touch-tone telephone. Please be advised that today's conference may be recorded. If you recall all the resistance, please press star, then zero. I would now like to hand the conference over to your speaker today. Lisa Wilson, Investor Relations for Time Technologies. Please go ahead.
spk01: Thank you, Lydia. Welcome to Time Technologies Fiscal First Quarter 2022 Earnings Results Call. This is Lisa Wilson of Insight Communications, Investor Relations for Time. With me on today's call are Richie Cunningham, Chief Executive Officer, and Frank Porfito, Chief Financial Officer of Time. With Dr. Jan von Tornout, Acting Chief Medical Officer, and Dr. Jonathan Eckert, Chief Business Officer, joining us for the Q&A portion. You can also access the webcast of this call through the investor section of the TIME website at timeinc.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 times management as of today and involve risks and uncertainties, including those noted in our press release 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. TIME 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, timelink.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on August 10th, 2021. Since then, time may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC filing. And with that, I'll turn the call over to Richie Cunningham, Chief Executive Officer of Time.
spk04: 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 time 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 HR-positive HER2-negative breast cancer as a strategic clinical setting for SM88, and we moved expeditiously to progress plans for the trial with Georgetown University. We presented interim data for the ongoing Phase 2 Hope Sarcoma Trial at ASCO 2021, and this trial is advancing to completion. We commenced a broad biomarker initiative around SM88 that we will believe help us optimize future development. We welcomed Dr. Van Turnout as acting chief medical officer and Frank Porfido as chief financial officer. We maintained 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 up front, our strategic review revealed 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 SM88, we're now focused on these key three programs. One, pancreatic cancer in second-line setting. Two, continuing to advance our work around sarcomas where there's a high unmet need. And three, 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 anti-tumor activity we previously observed in the setting, especially in HR-positive HER2-negative patients. SM88's oral 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 HR-positive HER2-negative 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 SM88 with MPS in patients with metastatic disease who have received two prior hormonal therapies and failed to progress 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're pleased to be partnered with Georgetown University on such an important study. Turning now to Precision Promise Trial. This is a Phase 2-3 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 estimated it was the first agent included in the trial. It is being studied as a monotherapy in second-line setting. We're pleased with the progress of this trial, and PANCAN recently announced that they are currently adding an additional five trial sites to the original 15 sites enrolled in the trial. The sites involved in the Precision Promise Trial are 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 working sarcomas, which are an array of different cancers, most of which have very few effective treatment options, leaving a high unmet need. We're 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. Time and the Joseph Ahmad Foundation continued to work with the Sarcoma Research Center in California to conduct a phase two hope study in sarcoma. The interim clinical data from the trial, which we presented at the 2021 ASCO General Meeting, supported the well-tolerated profile of SM88 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're continuing to work with the investigator to achieve the 24 predefined patient enrollment by early next year, and to identify potential development paths 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 preclinical studies. This is a truly exciting area of exploration for us. We announced a broad initiative to deepen our understanding of the effects of SM88 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 Evatech, 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 SM88. 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 Evotech across a range of cancers, and preclinical work at Georgetown focused on breast cancer models and estimated its impact on mechanisms of resistance to existing treatments. Moving on now to the time team. Having the right people in the right positions is a key success factor for us. And we strengthened our team this past quarter with the additions of Dr. Van Turnout as acting chief medical officer and Frank Profito 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 that had granted additional patent claims related to our metabolic and 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 anti-cancer drugs. The program right now is largely in the early preclinical phase. We have begun the kickoff and taking necessary steps to advance this technology. If it proves successful, it could be a significant asset and potential growth driver for time. 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 SM88, 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 in the OASIS breast cancer trial this quarter. We have a robust patent portfolio covering compositions, methods, manufacturing, and use to 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?
spk02: Thank you, Richie, and good morning, everyone. As Richie noted, We believe we are sufficiently well capitalized to allow us to advance our preclinical 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 SM88 clinical trials and employee-related expenses. Time anticipates that 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 3 cents per share. This compares to a net loss of approximately 8.8 million or 7 cents per share for the fiscal quarter of 2021. The decreased loss for the current three-month period is due to a favorable variance of $4.1 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 three-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.
spk00: Thank you, ladies and gentlemen. As a reminder, to ask a question, you will need to press the star then the one key on your touch-tone telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Again, the star one to ask a question. And I see we have a question coming from the line of Arthur here from HC Wainwright. Your line is open.
spk03: Good morning, everyone. This is Arthur for RK. Thank you for taking my question. 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? Thank you.
spk04: Yeah, absolutely. So right now, we're anticipating what we've communicated is that we're looking towards trial enrollment completeness sometime first half of 2022. We'll need the data to mature at some point and then we'll anticipate, you know, the data thereafter. With that being said, the endpoints are tumor response rate by recess, looking at durable treatment response, and time to disease advancing by looking at duration of treatment to progression. So that's the timing of it and the sort of data we're anticipating at that point in time.
spk03: So I had a follow on that. So based on that data, assuming the positive So what's your plan to go for a pivotal study?
spk04: Yeah, so again, we'll have to assess the data, assess, you know, what ultimately the data tells us. And then based on that, you know, it's a matter of then accelerating a path forward, identifying, you know, within Ewing sarcomas, there's a specific population that we're targeting there. So we're going to be looking at, you know, how to accelerate moving forward, move quickly, Um, you know, as you know, this is a rare disease, um, as we kind of look to expand this potential trial into, you know, a later kind of pivotal trial, you know, we'll have to engage, um, 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, you know, our goal would be is to move in an expeditious manner based on what the data is telling us and to move quickly.
spk03: Thank you. Thank you for taking my question.
spk00: And as a reminder, please press star 1. I'm showing no further questions at this time. I will now turn the call back over to Mr. Rishi Cunningham for any closing remarks.
spk04: Okay, great. Well, thank you again, Arthur, for the question, and thank you, Livia. Thank you. Appreciate it. We're pleased with the outcomes and the priorities that emerged from our comprehensive strategic review as what 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.
spk00: Ladies and gentlemen, that's all from our conference for today. Thank you for your participation. You may now disconnect.
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