Q1 2022 Tyme Technologies Inc Earnings Call
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Ladies and gentlemen, thank you for standing by and welcome to the time technologies fiscal first quarter 2020.2 results conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question. During this session you will need to press the start into 1 key on your Touchtone telephone.
Please be advised that today's conference maybe recorded if he would call offer assistance. 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.
Thank you Olivia welcome to time technologies fiscal first quarter 2020.2 earnings results call. This is Lisa Wilson of insight Communications Investor Relations for time with me on today's call are Ritchie Cunningham, Chief Executive Officer, and Frank Cookie Dough, Chief Financial Officer, Todd with doctors.
John von torn out acting Chief Medical Officer, and Dr. Jonathan Eckard, Chief business officer join Us for the Q&A portion.
You can also access the webcast of this call through the investors section of the time website at time and Dot 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.
These statements include those that express 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 times management as of today and.
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 and the forward looking statements.
<unk>, 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 timing dot com.
For the benefit of those who maybe listening to the web the replay or archived webcast. This call was held and recorded on August 10.2021.
Since then <unk> 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 Ritchie Cunningham Chief Executive officer of time.
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 and extremely productive period force. We recently completed a thorough strategic review of the company to assess opportunities and gaps and to map out the best path forward.
Our goals and determine the most efficient and effective use of our novel technology into identified which disease states and patient populations to focus on all.
All to help us ensure that our technology and resources and fully aligned to our opportunities.
We completed the strategic review and Q1 and believe that time is now better positioned to take full advantage of the many exciting opportunities before us.
As we will discuss this morning, we.
We have a number of promising programs underway and.
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.
Her 2 negative breast cancer as a strategic clinical study for SM 88 and <unk>.
And we moved expeditiously to the growth plans for the trial with Georgetown University.
We presented interim data for the ongoing phase II hopes sarcoma trial.
<unk> 2021, and this trial is advancing to completion and we.
And commenced the broad biomarker initiative around SM 88 that we believe help us optimize future development.
We welcome the Doctor of and in turn out as acting Chief Medical Officer, and Frank Placido as Chief Financial Officer.
We maintain financial discipline and ended the quarter with over $100 million and cash and marketable securities.
Now, let's take a look at each of these programs and more detail.
As I mentioned upfront.
Our strategic review of who built some overlap.
As well as other opportunities that were not being fully captured.
As a result, we took an important step of really our clinical price pipeline.
Given the strong early data with SM 88, we're now focused on these key 3 programs.
<unk> pancreatic.
Cancer and second line setting.
2 continuing to advance our work around Sarcomas.
There is a high unmet need and.
And 3 commencing a study in breast cancer.
Let me start with our work and breast cancer, we're particularly excited about this opportunity because of the promising anti tumor activity. We previously observed and the study, especially and HR positive her 2 negative patients.
In addition, SM 88, all delivery and current Tolerability profile.
Has 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.
HR positive her 2 negative cases represent approximately 73% of the breast cancer diagnosis and the United States.
During the quarter, we announced the Oasis trial.
And open label Phase II trial, examining SM 88, with NPS and patients with metastatic disease, who have received 2 prior hormonal therapies and failed or progressed after receiving a CDK 4.6 inhibitor agent.
The primary endpoint and the trial is overall response rate.
Trough preparations are advancing and we expect the first patient to be enrolled this quarter. We're pleased to be partnered with Georgetown University and such an important study.
Turning now to precision promise trial isn't.
This is a phase III 3 randomized adaptive trial and metastatic pancreatic cancer sponsored by the patriotic cancer action network or pay and can.
The trial will begin enrollment in April of 2020 and estimate it was the first agent included in the trial.
It is being studied as a monotherapy and second line study. We're pleased with the progress of this trial and paint and recently announced that they are currently adding an additional expired trial sites to the original 15 sites enrolled and the trial.
The sites involved and the precision promise trial are the top academic sites and the country for pancreatic cancer treatment and these additions should help expedite the enrollment into this important program.
Moving on to our work and Sarcomas.
Sure and array of different cancers.
Most of which have very few effective treatment options, leaving.
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, where therefore, maintaining sarcomas as a strategic priority.
Time, and the Joe's from Odd Foundation continued to work with the Sarcoma Research Center in California to conduct a phase II study and sarcoma.
Interim clinical data from the trial, which was presented at the <unk> 2021 and ask a general meeting.
And at the well tolerated profile of SM 88 to date and have several examples of clinical benefit and extended treatment durations that were longer than expected and this population.
With 16 patients currently enrolled in the trial and we're continuing to work with the investigators 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 and 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 force, we announced a broad initiative to deepen our understanding of the effects of SM 88, with the goal and identifying.
Potential biomarkers for screening or activity that could help us optimize future development from this drug.
We will be partnering with several well known organizations, including EBIT Tech, which is a global drug development company.
A pre <unk> and pre imminent.
Medical institutions, including Georgetown University, and why your 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 and a more efficient and effective manner.
During the quarter we.
And we were successful with Mayo clinic, and creating and characterizing many patient derived pancreatic cancer overnights.
Organoid are the foundation of the biomarker initiatives.
The aim will be to identify potential biomarkers for activity that can inform and hone and our clinical approach and into the future. Ultimately the goal of precision medicine, the speed and accuracy and we believe that studying biomarkers across patient populations and indications gives us the greatest chance of achieving that goal.
We also initiated a broad collaboration with Eva tech across a range of cancers and preclinical work at Georgetown and focus on breast cancer models and estimate its impact on mechanisms of resistance to existing treatments.
Moving on now to the Italian 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 and Dr. Van turn out exactly Chief Medical officer, and freight per <unk> as Chief Financial Officer.
Together, they add valuable expertise of our teams finance and drug development capabilities, and we look forward to their contributions.
Lasse.
And I'd like to briefly touch on and announcement, we made more recently and late July we received notification from the United States patent and trademark office and.
Granted additional patent claims related to our metabolic of cancer metabolism technology platform.
The patent involves the targeted delivery of therapeutics to cancer cells.
Specifically the concept is to use our patented piracy and analogs to a second therapeutic agent and.
And in a manner that creates a fusion compound that may allow targeted delivery to cancer cells and and novel manner.
This provides us with an opportunity expand our current cancer metabolism based approach with a drug delivery platform that is aimed at delivering toxic therapies and a targeted manner with the potential to improve and offer improved safety and efficacy for a range of anti cancer drugs and <unk>.
Program right now is largely and early preclinical phase.
<unk> begun to kick off and taking necessary steps to advance this technology. If it proves successful it could be a significant assets and potential growth driver per ton.
Looking ahead.
We have many important clinical programs in various stages of development.
We believe the company is well position 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 and the role of Biomarkers and advanced and treatments for cancer patients.
And to drive forward, our drug delivery efforts.
We're excited about achieving our near term milestones included dosing the first patient and the Oasis breast cancer trial this quarter.
In addition, we have a low both robust patent portfolio covering compositions methods manufacturing and use extending beyond 2032 and and innovative pipeline.
Accordingly.
We believe a strong financial foundation will allow us to execute on these priorities.
With that being said now I will turn the call over to Frank for a more detailed financial review of the quarter and our outlook.
Thank you Richard and good.
Morning, everyone.
As Richard 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 and cash cash equivalents and marketable securities.
Our operational cash burn rate for the first quarter was $6 million compared to $6 million.
7 in Q1, 2021 and the decrease of $700000 was attributable attributable to lower spending on SM 88, clinical trials and employee related expenses.
Time anticipate 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 <unk> <unk> per share.
This compares to a net loss of approximately $8.8 million or <unk> <unk> per share for the fiscal quarter of 2021.
The decreased loss for the current 3 month period.
Due to a favorable variance of 4 point.
And the change in fair value of the warrant liability offset by unfavorable variance of $2.2 million and prior year's game on the warrant exchange.
And decreased operating costs.
And $1.1 million.
The decrease in operating costs for the current 3 month period.
A $1.1 billion, 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.
Thank you, ladies and gentlemen, and as a reminder to ask a question you will need to press. The Star then the 1 key on your Touchtone telephone to withdraw your question press the pound key.
Please stand by while we compile the Q&A roster.
Again, Thats star 1 to ask a question.
And I said, we have a question coming from the line of Arthur <unk> from H C. H C. Wainwright Your line is open.
And good morning, everyone did you the odds are haynesville RK. Thank you for taking my question.
And regarding the sarcoma trial.
Could you give us more color on the potential data readout.
And next year and.
What kind of data set and we could expect and from that that the update thank you.
Yeah, absolutely so so right now.
And we're anticipating what we've communicated is that we're looking towards trial enrollment complete and that sometime first half of 2022.
You'll need the data to mature.
To some point and then we will anticipate.
The data thereafter with that being said the endpoints are tumor response rate by resist looking at durable treatment response and time to the vs. Advancing by looking at duration of treatment to progression. So that's the timing of it and what sort of data we are 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 4 it go for a pivotal study.
Yes, so again, we'll have to assess and data access.
Ultimately the data tells us and and based on that.
And matter of Ben and accelerating our path forward and identifying with the Ewing sarcoma and says the specifics specific population that we're targeting there. So we're going to be looking at how can we accelerate moving forward move quickly.
As you know this is a rare disease as we kind of look to expand this potential trial and to a later kind of pivotal trial.
I have to engage a broad group and doing so right now we're focused and working with 1 investigator and so theres a lot of work that needs to be done to expand the trial passed that so our goal would be as to move and expeditious manner based on what the data is telling us and the move quickly.
Thank you. Thank you for taking my question.
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 them and we should kind of him for any closing remarks.
Okay, great well. Thank you again author for for the question and thank you Olivia I appreciate it.
With the outcomes and the priorities that emerged from our comprehensive review strategic review is what was discussed during this quarter is always our focus is on innovation to benefit cancer patients and on delivering value to our stakeholders. We appreciate your interest and the company and we look forward to keeping you updated on our progress and thank you all for your time.
And together together today and and stay safe.
Ladies and gentlemen that that from car conference for today. Thank you for your participation you may now disconnect.
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