Q3 2022 Tyme Technologies Inc Earnings Call

Yeah.

Good day. Thank you for standing by that time technologies third fiscal quarter 2022 earnings results call. At this time, all participants are in a listen only mode.

After the speaker's presentation, there will be a question and answer session to ask a question. During this session will need to press star one on your telephone. Please be advised that today's conference is being recorded and if you could.

Any further assistance please press star zero.

And the conference over to your Speaker today, Lisa Wilson Investor Relations. Please go ahead.

Thank you operator, welcome to time technologies.

Third fiscal quarter 2022 earnings results call. This.

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 <unk>, Chief Financial Officer of time with Dr. Jan one torn out acting Chief Medical Officer, and Dr. Jonathan Eckard, Chief business officer, joining for the Q&A portion at the end of the call.

You can also access the webcast of this call through the Investor section of the time website at timing 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 statements include those that express the belief expectation projection forecast anticipation or intent regarding future events and the companys future performance.

These forward looking statements are based on information available to times management as of today and involve.

All risks and uncertainties, including those noted in our press release issued this morning, and our filings with the Securities and Exchange Commission.

Such forward looking statements are not guarantees of future performance actual results may differ materially from those projected in 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 90 days on our website time, Inc. Dot com.

For the benefit of those who may be listening to the replay or archived webcast. This call was held and recorded on February 11 2022.

Since then time may have made announcements related to the topics discussed. So please reference the Companys. Most recent press releases and Securities and Exchange Commission filings and with that I'll turn the call over to Ritchie Cunningham Chief Executive Officer of time.

Thank you Lisa.

And welcome everyone and thank you for joining the call. This morning.

As you will hear today time as a company with a diverse pipeline backed by compelling clinical data.

We're also in a strong financial position.

With approximately $92 million in cash and marketable securities at quarter end.

Which gives us the ability to execute on our current clinical initiatives.

As well as to assess some attractive options to build upon our pipeline.

As many of you know the precision promise trial conducted by the pancreatic cancer action.

Our pancreas.

With monotherapy SM 88 in second line pancreatic cancer was discontinued due to the lack of efficacy when compared to standard of care chemotherapy.

Naturally we.

We were incredibly disappointed to see one of our programs discontinued.

And I can speak for everyone at the company that.

We have great compassion for those suffering from pancreatic cancer.

We're eager to.

To provide those in need with a novel treatment.

Pancreatic cancer is recognized as a challenging setting for drug development.

As reflected by the numerous prior drugs that have been unsuccessful in showing clinical benefit.

Important to note.

Based on the information provided by <unk> Kim.

No new trends and serious adverse events have been reported from the precision promise trial.

And as we have reported previously there have been minimal serious adverse events reported on SM 88.

We remain committed to continuing our programs in breast cancer and sarcoma.

There are many examples of drug candidates finding success in other indications despite failing to succeed in pancreatic cancer.

We expect that to be the case with SM 88, and we remain confident in its potential efficacy.

Once we get the full dataset from Pan can we will conduct a thorough analysis.

Between this data and our ongoing biomarker work, we hope to better understand if there are particular patient subsets that youll benefit with SM 88.

As a reminder, estimated has demonstrated confirmed responses in 15 different cancer types and our previous first in human study and compassionate use program.

For those of you who are newer to time in our story.

I'll take a minute to provide background about how estimate works and the potential additional avenues for development.

<unk> is an orally administered cancer metabolism based therapy.

That is chemically altered.

Nonfunctional for fundamental tumor cell processes, including protein synthesis.

Scientific literature has highlighted that cancer sales can have a significantly higher consumption of certain amino acids compared to healthy cells. In these amino acids are required for cancer cell growth and function.

We believe that estimate.

Our proprietary modified dysfunctional tyrosine.

Flexibly consumed by cancer cells.

And interrupt various cell functions, including protein synthesis.

<unk> and other cellular defenses that ultimately leads to oxidative stress related apoptosis or cell death.

We also believe this selective cancer uptake of non essential amino acids.

<unk> by the current safety profile for estimating.

That has shown minimal observed drug related aes in the one hundreds of patients treated to date.

Regarding the patients treated to date in <unk>.

Conjunction with our strategic review last year.

We set about trying to better understand some of the early clinical work done on SM 88.

There were two concurrent studies.

One was the first in human study designed to investigate the safety and Tolerability of estimated 30 patients over a six week cycle with no concurrent cancer therapies.

The early results led to extended treatment for the majority of patients who would then followed to collect data on tumor responses and overall survival.

In parallel with this study there was a second related time supported expanded access compassionate use program being conducted.

This program allows for enrollment beyond the initial 30 patients.

Including for patients who may not have been eligible for the trial.

It was through these programs that the anti tumor efficacy signals were observed in 15 different cancer types as I mentioned before.

Notably.

Estimate each showed particular efficacy in breast cancer patients incur.

Including patients with hormonal positive and her two negative disease, which.

Which represent over 70% of the breast cancer diagnosis in the United States.

In this group of patients estimated eight had a 42% objective overall tumor response rate, which is one of the reasons for our focus in this area and our Oasis breast cancer trial.

The <unk> trial is an open label Phase II trial examining estimate eight with Fox Lynn Phenytoin and through all of this.

Our NPS.

In patients with metastatic hormone positive nature.

HR positive <unk> negative advanced breast cancer, who have received two prior hormonal therapies and failed or progressed.

After receiving a CDK <unk> inhibitor agent.

The way the study is being conducted by Georgetown University.

Through its medical network Medstar health.

The trial is focused on tumor response rates and are in gold is an effective well tolerated oral treatment for patients before they advance to chemotherapy treatment.

We currently have five sites open.

And as mentioned in last quarter's call.

We've begun enrollment and expect the data update in the first half of 2023.

We remain excited about the opportunity given the promising anti tumor activity previously observed in this study.

In addition to breast cancer sarcoma also emerged as a strategic indication through our estimate eight studies.

Sarcomas represent a range of different cancers with few effective treatment options and a high unmet medical need.

Which could potentially lead to an accelerated development path and approval.

With this investigator sponsored hope study, we've partnered with the Joseph Abboud Foundation.

Who is sponsoring the trial.

And as sarcoma oncology Research center in California.

Safety and quality of life or central to sarcoma patients and.

Physicians seek to extend the time until disease progression, while maintaining patient quality of life.

To date <unk>.

We've seen encouraging efficacy signals for our phase II study.

And have found several examples of extended treatment durations.

Many patients were able to stay on SMB longer than what they experienced on their prior therapies as well as anti tumor activity.

We continue to enroll patients and plan to complete enrollment in mid 2022.

Although the company remains focused on breast cancer and Sarcomas as mentioned earlier SM.

SM 88 has the potential to expand to other indications.

And we're exploring which areas could be the most beneficial for time to pursue.

Through our biomarker preclinical program, we aim to identify the settings, where the drug produces a significant response.

To achieve this objective we.

We've partnered with several pre eminent organizations.

And in Georgetown University NYU Medical Center.

<unk> clinic and Evo Tech.

And plan to use these results generated.

To guide our future clinical development.

We expect to report out in the data by mid 2022.

Our preclinical work also includes the development of a new tumor targeting technology.

Which would combine our patented tyrosine analogs with a second therapeutic agents.

We believe this fusion compound could offer a novel approach to the targeted delivery of a toxic therapeutic agent to cancer cells with an improved tolerability profile.

If our technology is able to selectively deliver cancer agents and a more precise way to the tumor.

We believe it could open up the door for partnering opportunities for a range of different cancer treatments.

We're also advancing our understanding of the potential utility of <unk> 19, and.

An oral synthetically produced member of the bile acid family that.

That has been studied for the treatment of COVID-19.

And possible future variants.

Based on the publicly reported projections.

22 consensus estimate for oral COVID-19 therapeutics is expected to be over $20 billion globally.

It is our belief that time 19 works in a manner that is not dependent on the COVID-19 spike protein to be effective in.

And differs from the recently approved drugs for Merck and Pfizer.

As a result, if approved it is possible that time 19 could end up being used in combination with other therapies to fight COVID-19 infections.

We expect to have time 19, MLA preclinical data in the first half of 2022.

With that I'll turn the call over to our CFO <unk> <unk> for a detailed financial review of the quarter and our outlook right.

Thank you Richard and good morning to everyone.

As Richard noted, we believe we are well capitalized to advance our preclinical and clinical development programs.

Based on our current operating plan.

Project, our cash balance and investments will be sufficient to fund us for approximately 36 months.

We closed the third quarter of fiscal year, 2022 with $92 million in cash.

Cash equivalents and marketable securities.

Our operational cash burn rate.

The second quarter.

Was $4 5 million.

<unk> to the third quarter of fiscal year 2021 of $5 9 million.

The year over year decrease.

$1 4 million was due to lower ongoing trial costs.

Primarily the discontinuation of the time 88 tank third line metastatic pancreatic cancer trial.

We expect our quarterly operational cash burn for the remaining quarter of the fiscal year to be in the range of $6 million to $7 million.

This incorporates some of the savings.

From the precision promise trial that was discontinued.

For the third quarter of fiscal year 2022, we reported a net loss of $5 3 million or a loss of <unk> <unk> per share.

The net loss for the nine months of fiscal year 'twenty, two was $16 8 million.

Or a loss of <unk> <unk> per share.

This compares to a net loss of approximately $6 1 million or a loss of <unk> <unk> per share for the third quarter of fiscal year 2021.

And a $21 8 million loss.

Or <unk> <unk> per share for the first nine months of fiscal year 2021.

The year over year decrease in losses of <unk> 8 million for the three months period.

Largely due to the lower clinical trial costs for <unk>.

Dominantly the decrease.

In time 88 peg trial costs.

The year over year decrease in losses of $5 million for the nine month period due to the variable net value of $2 4 million related to the noncash warrant related expenses and lower operating costs of $2 6 million.

Reflecting lower research and development expenses of $1 9 million due to lower ongoing trial cost.

And lower general and administrative expenses of <unk> 7 million.

I'll now turn the call back to Ritchie for his closing comments.

We'll then open it up for your questions Richie.

Thanks Frank.

So before we move to take your questions.

I want to first share a few final thoughts.

First.

We remain confident and committed and SM 88, and its potential impact on breast cancer and sarcoma.

In addition.

We will continue to explore the broad activity observed in the first in human studies together with the buyer market data as they emerge.

One of the stated goals coming out of last year's strategic review.

Was to diversify our pipeline.

You've also heard us talk about our very strong financial position.

This provides us with the flexibility to consider other compelling cancer drugs under development.

There are many interesting assets that are currently in need of capital.

So we believe it is an opportune time for any well funded company to consider that path.

Bringing in a product candidate that has a different mechanism than estimate eight could also add to the diversity of our pipeline.

As those in the biotech space are well aware pie.

Pipeline setbacks are part of the difficult process of developing new drugs.

But our march towards bringing compelling novel agents that will help people in need is far from over.

Our plan is to continue learning more about estimating eight through our preclinical and biomarker work.

Add clinical sites for the trials were enrolling.

And utilize our financial strength to potentially bring in a new program or commenced another one internally.

The team and I remain optimistic about the potential of SM 88, as well as the other opportunities to drive value for patients and all time stakeholders.

And with that I'll open up the call to your questions operator.

Please.

As a reminder to ask a question you will need to press star.

One on your telephone.

To withdraw your question press the pound key please standby only compile the Q&A roster.

Once again Thats star one for a question Star one.

And at this time im not showing any questions in the queue.

I'd like to turn the call back over to Ritchie Cunningham CEO for any closing remarks.

Thank you operator.

And thanks to everyone for listening in today and for your interest and time.

We certainly look forward to updating you on our progress moving forward.

They say.

And this concludes today's conference call. Thank you for participating you may now disconnect everyone have a great day.

Okay.

Okay.

Okay.

Okay.

[music].

Okay.

Yes.

[music].

Yes.

Okay.

Yes.

Okay.

Thanks.

Thanks.

Okay.

[music].

Okay.

Okay.

[music].

Yes.

[music].

[music].

[music].