Q2 2022 Tyme Technologies Inc Earnings Call
[music].
Yes.
Good day, ladies and gentlemen, and welcome to the time technologies second fiscal quarter 2022 earnings results call. At this time all participant lines are in a listen only mode. Later, we will conduct a question and answer session and instructions will be given at that time to ask a question you will need to press Star then one on your telephone as well.
Reminder, this call is being recorded if anyone should require operator assistance. Please press Star then zero I would now like to hand, the conference over to your host today, Lisa Wilson Investor Relations for time. Please go ahead.
Thank you operator, welcome to time technologies second fiscal quarter 2022 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 Frankfurt, Vito Chief Financial Officer at a time.
With Doctor Jan Van torn up acting Chief Medical Officer, and Dr. Jonathan Eckard, Chief business officer, joining for the Q&A portion at the end of this call.
You can also access the webcast of this call through the investors section of the time website at time, Inc. 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 a belief expectation projection forecast anticipation or intent.
Guarding future events and the company's future performance.
These forward looking statements are based on information available at the time as management as of today and involve risks and uncertainties, including those noted in our press release issued this morning, and our filings with the SEC.
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 at 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 November eight 2021.
Since then time may have made announcements related to the topics discussed. So please reference the company's 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 to our presentation. This morning, and thank you for the opportunity to share the progress we've made during our second fiscal quarter.
It's been a very active and productive quarter as we advanced our key strategic initiatives.
I'll touch on some of the highlights now and then discuss them in a bit more detail in a minute.
To start.
I'm pleased to report that we've achieved a key milestone this past quarter with.
With the first patient enrolled in the Oasis breast cancer trial.
This trial is focused on tumor response rates.
And our Ingalls in this setting would be effective.
Well tolerated all treatment.
These patients before they advance to chemotherapy treatment.
This study aligns with our mission to.
To deliver viable treatment options to cancer patients without compromising quality of life.
And by doing so we believe we can truly make a positive impact in their fight against cancer.
Another highlight of this past quarter is the expansion announcement of precision promise pancreatic cancer trial.
And Ken will be doubling the number of current sites.
With an additional five sites that are expected to be added in early calendar year 2022.
And then another 10 sites to be added by the end of calendar year 2022.
Doubling the original sites from 15 to 30.
We believe these efforts will help accelerate the study while growing the geographic footprint to capture an even larger proportion of the treat of pancreatic cancer patients in the U S.
In addition, we have seen a meaningful increase in the rate of enrollment with our hopes sarcoma trial.
This is due in large part to the internal time team implementing initiatives to identify potential eligible patients with this ultra rare disease.
The team is now focused on getting remaining patients enrolled in the trial and we're targeting enrollment completion by the first half of calendar year 2022.
Importantly, we also kicked off our preclinical initiatives with Evo Tech.
Who you May know is a global leader in drug development.
EBIT check has been asked to evaluate the potential of expanding our S immediate platform to other indications as well as to explore the potential for the development of a novel tumor targeting technology utilizing our patented tyrosine based analogs.
Overall, we're making steady progress both clinically and pre clinically.
With $96 6 million of cash and cash equivalents in marketable securities on hand at quarter end, we believe we're well funded to advance and execute on our clinical programs and preclinical initiatives.
Now for those of you who are just getting to know time.
Overall, our approach is focused specifically and selectively targeting cancer in a unique way.
The selectivity of the cancer is very important and why we believe estimate it has had such a favorable toxicity profile and the hundreds of patients treated to date.
Let me briefly touch on some of the early estimate results that support our view that this is a very promising therapy.
The completed and published first in human study was designed to investigate the safety and Tolerability of the therapy and patients over a single six week cycle.
The study was running 30 patients with no concurrent cancer therapies.
The early efficacy results of estimate eight ultimately led to the extended treatment with the majority of patients which were then followed for tumor responses and overall survival.
In parallel with the study.
I'm also help support an expanded access compassionate use program.
This program was run under the same institutional review board or IRB.
And it was done at New York Presbyterian.
But it allowed patients beyond the initial third capturing some who might not have qualified for the first in human study.
All patients in the expanded access program had metastatic and progressive disease.
The majority of patients in the compassionate use program received estimating as a monotherapy.
However, there were some patients that received estimate in combination with other anti cancer therapies, such as chemotherapy and radiation, but this typically met these patients we're continuing a drug from the last regimen.
And due to disease progression looking for alternative treatments.
For example in breast cancer.
Patients were kept on an aromatase inhibitors or hormonal agents, because physicians felt stopping needs could accelerate the cancer growth.
These patients were progressing on current therapies upon starting estimated treatment.
Now Keith.
Key takeaways here are that through these two programs. We saw confirmed responses in 15 different cancer types, including complete and partial responses in breast cancer.
This is in our view was an impressive result, which supported the rationale for current clinical development.
Now with this background, let's go through our programs in more depth.
Starting with our work in breast cancer.
As I mentioned at the start of the call we've enrolled the first patient in Oasis trial.
The study is being conducted by Georgetown University at its five Medstar health hospitals.
Medstar health is georgetown's academic clinical partner and we're excited to be collaborating with them on such an important study.
By way of background Oasis is an open label phase two trial examining SM 88, with the Sox win phenytoin, and Sirolimus or M. P S and.
Patients with metastatic hormone positive in her two negative advanced breast cancer, who have received two prior hormonal therapies and failed or progressed after receiving a CDK four six inhibitor agent.
The primary endpoint of the trial is overall response rate.
We are particularly excited about the opportunity because of the promising anti tumor activity previously observed in this study.
Especially in HR positive <unk> negative patients.
Which account for approximately 73% of the breast cancer diagnoses in the U S.
As a reminder, in this setting we saw an impressive result, with complete responses and partial responses in the two studies I just discussed.
We believe we can reproduce this type of result in the current Oasis trial.
But it could be incredibly impactful from time and these patients.
Turning now to the precision promise strong where oral SM 88 is being studied as a monotherapy and the second line setting in advanced metastatic pancreatic cancer.
The trial is designed.
As he seamless phase three randomized adaptive trial that is sponsored by the pancreatic cancer action network or panicking.
<unk> is a well known organization and a globally recognized leader in advocacy for pancreatic cancer patients.
Important to note this.
This study is.
Is considered by the FDA as a pivotal phase III study that will evaluate the effect of all estimated eight and all 175 patient scheduled to be treated in this study.
This adaptive randomized platform trial of.
Evaluates all estimating in two stages.
In the first stage up to 100 patients are enrolled and treated with oral SM 88.
At which point a formal evaluation of efficacy and Tolerability is determined by an independent Statistical review in order to proceed to stage two.
If the current enrollment metrics, we are experiencing a sustained.
We believe enrollment completion and determination, where the first stage review will occur by the second half of calendar year 2022.
Now SM 88 clears the first stage review of 100 patients. The next 75 patients enrolled would then be treated to confirm the initial efficacy and tolerability results from stage one.
If that's the immediate cause both efficacy reviews from stage, one and stage two.
<unk> anticipates utilizing these results.
To support an NDA application for approval in this setting.
So again the precision promise trial began with 15 clinical sites. They include premier pancreatic cancer treatment sites across the United States.
As previously mentioned Pantene is working to double the number of sites in the U S to 30.
The end of calendar year 2022.
Which we believe will play a significant role in helping expedite further enrollment.
Moving on to our work in sarcoma.
Which represent an array of different cancers with few effective treatment options.
And therefore, a high unmet need.
As you may recall for the hope study.
We partnered with the Joseph Abboud Foundation, who is sponsoring the trial.
In the sarcoma oncology Research center in California.
Safety and quality of life are essential to the sarcoma patients.
And clinically physicians are seeking to extend the time until disease progression, while maintaining the patient's quality of life.
The early efficacy signals for our phase two hope study are encouraging.
So far.
Interim clinical data supports the well tolerated profile of SM 88.
And we found several examples of extended treatment durations in patients with advanced Sarcomas and or using sarcomas, meaning these patients were able to stay on estimate eight significantly longer than prior therapies.
I stated earlier, we're targeting completion of enrollment by the first half of calendar year 2022.
To date the company is focused on three areas, which we've just reviewed first cancer pancreatic cancer and sarcoma.
But estimate it has the potential to.
To expand to other indications, especially as it's shown confirmed responses in 15 different cancer types during our first in human trial.
Now through our biomarker research, we aim to identify other areas of expansion. We're estimating produces a significant preclinical efficacy response.
We're actively investing in the work to deepen our understanding of its possibilities.
For this initiative.
Which we believe has the potential to produce critical insights.
We will be partnering with several well known organizations and pre eminent medical institutions, including Georgetown University.
NYU Medical center, the Mayo clinic and Evo Tech.
These studies have the potential to yield valuable new insights to move forward on the path of precision medicine by identifying targeted sub populations of patients.
We plan to use the data to guide our future clinical development and a more effective than.
This is truly an exciting area of exploration and we look forward to sharing our findings as information emerges.
Switching gears a bit.
A quick update on other initiatives beyond cancer therapy programs, which we're very excited about it.
We're in the early stages of attempting to develop.
A tumor targeting technology, which combines our patented piracy analogs to a second therapeutic agent to create infusion compounds.
When that occurs we believe it could allow for a novel approach.
And the targeted delivery of a toxic therapeutic agent with specificity the cancer cells, while showing a tolerability profile similar to what we're currently experiencing with SM 88.
We will also continue to invest preclinical to further advance our understanding of the potential utility of time 19, a bile acid program for the treatment of COVID-19.
From an intellectual property standpoint, we have over 200 patent applications pending and granted globally, which we believe gives time strong coverage on our pipeline.
All in we have a robust and diverse pipeline in various stages of development.
There are protected by a robust IP estate.
We will continue to drive forward, our clinical programs, while deepening our understanding of the potential of SM 88.
With ample cash on hand.
And an experienced management team in place we believe the company is well positioned to successfully execute on our initiatives.
Now I'll turn the call over to Frank for a detailed financial review of the quarter and our outlook Frank.
Thank you Richard and good morning, everyone.
As Richard noted, we believe we are well capitalized to advance our preclinical and clinical development programs.
On our current operating plan, we project, our cash balance and the investments will be sufficient to fund us for at least 36 months.
We closed the second quarter of fiscal year, 2022, with $96 6 million in cash cash equivalents and marketable securities.
Our operational cash burn rate for the second quarter was 5 million compared to $6 6 million and <unk>.
Q2 of fiscal year 2021.
The decrease of $1 6 million was due to lower ongoing trial costs, primarily due to the discontinued time 88, Pink third line metastatic pancreatic cancer trial.
As our initiatives ramp up we expect our quarterly operational cash burn for the remaining two quarters of the fiscal year to be in the range of $6 million to $8 million.
For the second quarter of 2022.
We reported a net loss of $5 6 million or a loss of <unk> <unk> per share and the net loss for the six months of 2022 was $11 5 million or a loss of seven cents per share.
This compares to a net loss of approximately $6 8 million or a loss of five cents per share for the second quarter of 2021, and $15 7 million or a loss of <unk> 12 per share for the first six months of 2021.
Decrease in losses of $1 2 million for the current three month period is largely due to lower clinical trial costs.
Predominantly the decrease in 88 paint cost.
The decrease in losses of $4 2 million for the current six month period.
Due to the favorable net variance of $2 3 million related to noncash related expenses, such as the change in fair value of the warrant liability and stock based compensation expense.
As well as $1 9 million related to decreased operating costs.
Primarily due to lower ongoing trial expenses.
I'll now turn the call back to Richard for his closing comments and we will then open it up.
To your questions.
Thanks Frank.
So as you've heard today.
We have a well defined plan.
And the means to execute on our plan to advance our pipeline.
We are addressing large market opportunities with differentiated therapies in areas with limited or no options for patients.
Our diversified pipeline continues to garner interest from Premier institutions, and time has assembled an experienced team to develop these compounds.
We strive to make a difference in the lives of people and we endeavor to help and reward the stakeholders, who give us the ability to do just that.
We believe just one of our many programs in development is successful.
It will have a meaningful impact on our company of our size.
And with that I'll open up the call to your questions. Operator. Please proceed.
Thank you to ask a question you will need to press Star then one on your telephone to withdraw your question. Please press the pound key please standby, while we compile the Q&A roster.
Yeah.
Again that is star then one if he would like to ask a question.
Yeah.
There are no questions at this time.
I will now turn the call back to Mr. Cunningham for closing remarks.
Thank you Sir.
We've shared with you today, we're making important progress in our ongoing trials as well as inroads with our preclinical work.
We look forward to updating you next quarter and we thank you for your time today stay safe everyone and thanks again.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.
Okay.
[music].
Okay.
Got it.
Yes.
Yes.
Yes.
Yes.
Yes.
Thank you.
Okay.
Okay.
Okay.
Okay.
Yeah.
[music].
[music].
[music].
Good day, ladies and gentlemen, and welcome to the time technologies second fiscal quarter 2022 earnings results call. At this time all participant lines are in a listen only mode. Later, we'll conduct a question and answer session and instructions will be given at that time to ask a question you will need to press Star then one on your telephone as a reminder.
This call is being recorded if anyone should require operator assistance. Please press Star then zero I would now like to hand, the conference over to your host today, Lisa Wilson Investor Relations for time. Please go ahead.
Thank you operator, welcome to time technologies second fiscal quarter 2022 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 poor Phaedo, Chief financial Officer of time with.
With Doctor Jan Van torn up acting Chief Medical Officer, and Dr. Jonathan Eckard, Chief business officer, joining for the Q&A portion at the end of this call.
You can also access the webcast of this call through the investors section of the time website at time, Inc. 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 a 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 time of management as of today and involve risks and uncertainties, including those noted in our press release issued this morning, and our filings with the SEC.
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 at 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 November eight 2021.
Since then time may have made announcements related to the topics discussed. So please reference the company's 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.
Okay.
Thank you Lisa and welcome everyone to our presentation. This morning, and thank you for the opportunity to share the progress we've made during our second fiscal quarter.
It's been a very active and productive quarter as we are.
Advanced our key strategic initiatives.
I'll touch on some of the highlights now.
Then discuss them in a bit more detail in a minute.
To start.
I'm pleased to report that we've achieved a key milestone this past quarter.
With the first patient enrolled in the Oasis breast cancer trial.
This trial is focused on tumor response rates.
And our goal in this setting.
<unk> is well tolerated oral treatment for these patients before they advance to chemotherapy treatment.
This study aligns with our mission to.
To deliver viable treatment options to cancer patients without compromising quality of life.
And by doing so we believe we can truly make a positive impact in their fight against cancer.
Another highlight of this past quarter is the expansion announcement of precision promise pancreatic cancer trial.
And Ken will be doubling the number of current sites.
With an additional five sites that are expected to be added in early calendar year 2022.
And then another 10 sites to be added by the end of calendar year 2022.
Doubling the original sites from 15 to 30.
We believe these efforts will help accelerate the study while growing the geographic footprint to capture an even larger proportion of the treat of pancreatic cancer patients in the U S.
In addition, we have seen a meaningful increase in the rate of enrollment with our hopes sarcoma trial.
This is due in large part to the internal time team implementing initiatives to identify potential eligible patients with this ultra rare disease.
The team is now focused on getting remaining patients enrolled in the trial and we're targeting enrollment completion by the first half of calendar year 2022.
Importantly, we also kicked off our preclinical initiatives with Evo Tech.
Who you May know is a global leader in drug development.
<unk> has been asked to evaluate the potential of expanding our S immediate platform to other indications as well as to explore the potential for the development of a novel tumor targeting technology utilizing our patented tyrosine basically analogs.
Overall, we're making steady progress both clinically and pre clinically.
With $96 $6 million of cash and cash equivalents in marketable securities on hand at quarter end. We believe we are well funded to advance and execute on our clinical programs and preclinical initiatives.
Now for those of you who are just getting to know time.
Overall, our approach is focused specifically and selectively targeting cancer and a unique way.
The selectivity of the cancer is very important and why we believe estimate he has had such a favorable toxicity profile and the hundreds of patients treated to date.
Let me briefly touch on some of the early estimate results that support our view that this is a very promising therapy.
The completed and published first in human study was designed to investigate the safety and Tolerability of the therapy and patients for a single six week cycle.
The study was running 30 patients with no concurrent cancer therapies.
The early efficacy results of estimate eight ultimately led to the extent of treatment with the majority of patients, which was then followed for tumor responses and overall survival.
In parallel with the study.
I am also help support an expanded access compassionate use program.
This program was run under the same institutional review board or IRB.
And it was done at New York Presbyterian.
But it allowed patients beyond the initial 30, capturing some who might not have qualified for the first in human study.
All patients in the expanded access program had metastatic and progressive disease.
The majority of patients in the compassionate use program received estimating as a monotherapy.
However, there were some patients that received estimating it in combination with other anti cancer therapies, such as chemotherapy and radiation.
This typically met these patients we're continuing our drawn from the last regimen.
And due to disease progression, we're looking for alternative treatments.
For example in breast cancer.
Some patients were kept on an aromatase inhibitors are hormonal agents, because physicians felt stopping needs could accelerate the cancer growth.
As these patients were progressing on current therapies upon starting SMA treatment.
Now Keith.
He's takeaways here are that through these two programs. We saw confirmed responses in 15 different cancer types, including complete and partial responses in breast cancer.
This is in our view was an impressive result, which supported the rationale for current clinical development.
Now with this background, let's go through our programs in more depth.
Starting with our work in breast cancer.
As I mentioned at the start of the call we've enrolled the first patient in Oasis trial.
Studies being conducted by Georgetown University at its five Medstar health hospitals.
Medstar health Georgetown academic clinical partner.
We're excited to be collaborating with them on such an important study.
By way of background <unk>.
This is an open label phase two trial examining SM 88, with thoughts, one phenytoin and thrombus or M. PFS in patients with metastatic hormone positive in her two negative advanced breast cancer, who have received two prior hormonal therapies and failed or progressed after.
Receiving a CDK four six inhibitor agent.
The primary endpoint of the trial is overall response rate.
We are particularly excited about the opportunity because of the promising anti tumor activity previously observed in this setting.
Especially in HR positive <unk> negative patients with.
Which account for approximately 73% of the breast cancer diagnoses in the U S.
As a reminder, in this setting we saw an impressive result, with complete responses and partial responses in the two studies I just discussed.
We believe if we can reproduce this type of result in the current Oasis trial.
That it can be incredibly impactful from time and these patients.
Turning now to the precision promise Trump where oral SM 88 is being studied as a monotherapy and the second line setting in advanced metastatic pancreatic cancer.
The trial is designed.
As a seamless phase II three randomized adaptive trial is sponsored by the pancreatic cancer action network or pancakes.
<unk> is a well known organization and a globally recognized leader in advocacy for pancreatic cancer patients.
Important to note this study.
Is considered by the FDA as a pivotal phase III study that will evaluate the effect of all estimate eight and all 175 patient scheduled to be treated in this study.
This adaptive randomized platform trial evaluates.
Evaluates all estimating in two stages.
In the first stage up to 100 patients are enrolled and treated with oral SM 88.
At which point a formal evaluation of efficacy and Tolerability is determined by independent Statistical review in order to proceed to stage two.
If the current enrollment metrics, we are experiencing are sustained.
We believe enrollment completion and determination with the first stage review will occur by the second half of calendar year 2022.
Now SM 88 clears the first stage review of 100 patients. The next 75 patients enrolled would then be treated to confirm the initial efficacy and tolerability results from stage one.
If that's the immediate cause both efficacy reviews from stage, one and stage two.
<unk> anticipates utilizing these results.
To support an NDA application for approval in this setting.
So again the precision promise trial began with 15 clinical sites. They include premier pancreatic cancer treatment sites across the United States.
As previously mentioned Pantene is working to double the number of sites in the U S to 30 by the.
The end of calendar year 2022.
Which we believe will play a significant role in helping expedite further enrollment.
Moving on to our work in sarcoma.
Which represent an array of different cancers with few effective treatment options.
And therefore, a high unmet need.
As you may recall for the hope study.
We've partnered with the Joseph Abboud Foundation, who is sponsoring a trial.
In the sarcoma oncology Research center in California.
Safety and quality of life are essential to the sarcoma patients.
And clinically physicians are seeking to extend the time until disease progression, while maintaining the patient's quality of life.
The early efficacy signals for our phase two hope study are encouraging.
So far.
Interim clinical data supports the well tolerated profile of SM 88.
And we found several examples of extended treatment duration in patients with advanced Sarcomas and or do you mean sarcomas, meaning these patients were able to stay on estimate eight significantly longer than prior therapies.
As stated earlier, we're targeting the completion of enrollment by the first half of calendar year 2022.
To date the company is focused on three areas, which we've just reviewed first cancer pancreatic cancer and sarcoma.
But estimate it has the potential.
To expand to other indications, especially as it's shown confirmed responses in 15 different cancer types during our first in human trial.
Now through our biomarker research, we aimed to identify other areas of expansion. We're estimating produces a significant preclinical efficacy response.
We're actively investing in the work to deepen our understanding of its possibilities.
For this initiative.
Which we believe has the potential to produce critical insights.
We will be partnering with several well known organizations and pre eminent and medical institutions, including Georgetown University.
Why you Medical center, the Mayo clinic and Evo Tech.
These studies have the potential to yield valuable new insights to move forward on the path of precision medicine by identifying targeted sub populations of patients.
We plan to use the data to guide our future clinical development and a more effective manner.
This is truly an exciting area of exploration and we look forward to sharing our findings as information emerges.
Switching gears a bit.
A quick update on other initiatives beyond cancer therapeutic programs, which we're very excited about.
We're in the early stages of attempting to develop.
A tumor targeting technology, which combines our patented piracy analogs to a second therapeutic agent to create infusion compounds.
When that occurs we believe it could allow for a novel approach.
The targeted delivery of a toxic therapeutic agent with specificity the cancer cells, while showing a tolerability profile similar to what we're currently experiencing with SM 88.
We will also continue to invest pre clinically to further advance our understanding of the potential utility of <unk> 19, a bile acid program for the treatment of COVID-19.
From an intellectual property standpoint, we have over 200 patent applications pending and granted globally.
Which we believe gives time strong coverage on our pipeline.
All in we have robust and diverse pipeline in various stages of development.
There are protected by a robust IP estate.
We will continue to drive forward, our clinical programs, while deepening our understanding of the potential of SM 88.
With ample cash on hand.
And an experienced management team in place we believe the company is well positioned to successfully execute on our initiatives.
Now I'll turn the call over to Frank for a detailed financial review of the quarter and our outlook Frank.
Thank you Richard and good morning, everyone.
As Richard noted, we believe we are well capitalized to advance our preclinical and clinical development programs.
On our current operating plan, we project, our cash balance and investments will be sufficient to fund us.
For at least 36 months.
We closed the second quarter of fiscal year, 2022, with $96 6 million in cash cash equivalents and marketable securities are.
Our operational cash burn rate for the second quarter was 5 million compared to $6 6 million and <unk>.
Q2 of fiscal year 2021.
The decrease of $1 6 million was due to lower ongoing trial costs, primarily due to the discontinued time 88 tank third line metastatic pancreatic cancer trial.
As our initiatives ramp up we expect our quarterly operational cash burn for the remaining two quarters of the fiscal year to be in the range of $6 million to $8 million.
For the second quarter of 2022.
We reported a net loss of $5 6 million or a loss of <unk> <unk> per share and the net loss for the six months of 2022 was $11 5 million or a loss of seven cents per share.
This compares to a net loss of approximately $6 8 million or a loss of five cents per share for the second quarter of 2021, and $15 7 million or a loss of 12 <unk> per share for the first six months of 2021.
Decrease in losses of $1 2 million for the current three month period is largely due to lower clinical trial costs.
Predominantly the decrease in 88 paint cost.
The decrease in losses of $4 2 million for the current six month period.
Due to the favorable net variance of $2 3 million related to noncash related expenses, such as the change in fair value of the warrant liability and stock based compensation expense.
As well as $1 9 million related to decreased operating costs.
Primarily due to lower ongoing trial expenses.
I'll now turn the call back to Ritchie for his closing comments and we'll then open it up to.
To your questions.
Thanks Frank.
So as you've heard today.
We have a well defined plan and.
And the means to execute on our plan to advance our pipeline.
We are addressing large market opportunities with differentiated therapies in areas with limited or no options for patients.
Our diversified pipeline continues to garner interest from Premier institutions, and time has assembled an experienced team to develop these compounds.
We strive to make a difference in the lives of people and we endeavor to help and reward the stakeholders, who give us the ability to do just that.
We believe is just one of our many programs in development is successful.
It will have a meaningful impact on a company of our size.
And with that I'll open up the call to your questions. Operator. Please proceed.
Thank you.
I'll ask a question you will need to press Star then one on your telephone to withdraw your question. Please press the pound key please standby, while we compile the Q&A roster.
Again that is star then one if you would like to ask a question.
Yes.
Okay.
There are no questions at this time.
I'll now turn the call back to Mr. Cunningham for closing remarks.
Thank you Sarah.
As we've shared with you today, we're making important progress in our ongoing trials as well as inroads with our preclinical work we.
We look forward to updating you next quarter and we thank you for your time today stay safe everyone and thanks again.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.