Q4 2021 Salarius Pharmaceuticals Inc Earnings Call
[music].
Good day and thank you for standing by.
Good day, and thank you for standing by.
Welcome to Q4 2021 Solarius Pharmaceuticals Earnings Webcast and Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session.
Welcome to Q4, 2021, hilarious Pharmaceuticals earnings webcast and conference 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, you will need to press star 1 on your telephone.
Ask a question during this session you will need to press star one on your telephone.
If you require any further assistance, please press star zero.
You're correct any further assistance please press star zero.
I would now like to hand the conference over to Jason Randolph of CBRAND Strategic Advisors. Please go ahead.
I would now like to hand, the conference over to Jason Rando <unk> strategic advisors. Please go ahead.
Jason Randolph: Good afternoon and thank you for joining Solaris Pharmaceuticals 2021 fourth quarter and full year financial and corporate results call.
Good afternoon, and thank you for joining Soliris Pharmaceuticals, 2021, fourth quarter and full year financial and corporate results call.
Jason Randolph: This afternoon, Slayer's Pharmaceuticals issued a press release detailing its financial results for the three months and full year ended December 31st, 2021, which we encourage listeners to read.
Good afternoon, Ladies Pharmaceuticals issued a press release detailing its financial results for the three months and full year ended December 31, 2021, which we encourage listeners to read.
Jason Randolph: The press release can be found in the news section of solariusfarmer.com.
The press release can be found in the news section of Soliris farmer dotcom.
Jason Randolph: Before beginning today's call, I would like to make the following statement.
Before beginning todays call I would like to make the following statement.
Jason Randolph: Today, we'll be making certain forward-looking statements about operating metrics, future expectations, plans, events, and circumstances.
Today, we'll be making certain forward looking statements about operating metrics future expectations plans events and circumstances.
Jason Randolph: including statements about our strategy, future operation, the development and effectiveness of our investigational drug candidates, Ceclodemstat, and SP3164, as well as our targeted protein degradation program.
Please statements about our strategy future operations, the development and the effectiveness of our investigational drug candidates <unk>.
<unk> set an FSP 364, as well as our targeted protein degradation program.
Jason Randolph: and expectations regarding our capital allocation and cash resources. These statements are based on our current expectations, and you should not place undue reliance on these statements.
And expectations regarding our capital allocation and cash resources.
These statements are based on our current expectations and you should not place undue reliance on these statements.
Actual results may differ materially due to our risks and uncertainties, including those detailed in the risk factors section of Soliris Pharmaceuticals annual report on Form 10-K for the year ended 2021, and subsequent quarterly reports on Form 10-Q , which have been filed with the SEC as well as well as in other filings.
Jason Randolph: Including those details in the risk factors section of Solaris Pharmaceuticals annual report on Form 10-K for the year ended 2021 and subsequent quarterly reports on Form 10-Q which have been filed with the SEC as well as in other filings we make with the SEC from time to time.
Make with the SEC from time to time.
Jason Randolph: Solaris Pharmaceuticals disclaims any obligation to update information contained in these forward-looking statements, whether as a result of new information, future events, or otherwise.
So first pharmaceuticals disclaims any obligation to update information contained in these forward looking statements, whether as a result of new information future events or otherwise.
Jason Randolph: With us on today's call is David Arthur, Director and CEO of Solaris Pharmaceuticals, who provided an update on Solaris' corporate and clinical achievements during the fourth quarter and its vision for the future.
With us on today's call are David Arthur Director, and CEO , Slayers Pharmaceuticals, who will provide an update ancillary since corporate and clinical achievements during the fourth quarter and its vision for the future.
Jason Randolph: And Mark Rosenblum, CFO , will review Solaris's fourth quarter financial results.
And Mark Rosenblum, CFO will review Solaris since fourth quarter financial results.
David Please go ahead.
Mark Rosenblum: Thank you, Jason. And thank you to everyone dialing into our conference call, particularly all of you joining us for the first time.
Thank you, Jason and thank you to everyone dialing into our conference call, particularly all of you joining us for the first time.
Mark Rosenblum: Last year and recent weeks were an exciting time for Solaris, highlighted by the continuing progress developing Secwed MSTAT and the expansion of our development pipeline.
Last year in recent weeks, where an exciting time for <unk> highlighted by the continuing progress developing second with <unk> staff and the expansion of our development pipeline.
Mark Rosenblum: In January , we acquired a portfolio of assets from Dudorex, LLC, which included the drug candidate 3164, SP3164.
In January we acquired a portfolio of assets from <unk> LLC, which included the drug candidate <unk> 164, SP $31 64.
Mark Rosenblum: a related intellectual property portfolio, and the opportunity to develop additional cancer-fighting assets.
Our related intellectual property portfolio and the opportunity to develop additional cancer fighting assets.
Mark Rosenblum: This acquisition formed the basis of our new cancer drug development program focused on targeted protein degradation, a fast-growing field of cancer.
This acquisition formed the basis of our new cancer drug development program focused on targeted protein degradation.
The fast growing field of cancer drug research.
Mark Rosenblum: With this one transaction, Solaris has grown from a company with a single clinical program into a company with an internal pipeline consisting of multiple drug development programs built around two exciting approaches to cancer drug development, protein inhibition and protein.
With this one transaction Soliris has grown from a company with a single clinical program into a company with an internal pipeline consisting of multiple drug development programs built around two exciting approaches to cancer drug development.
Protein inhibition and protein degradation.
Mark Rosenblum: This acquisition marks a significant step forward for Solaris and provides a bookend for what was a busy 2021, where in addition to advancing CYCLADEMSTAT,
This acquisition marks a significant step forward for Soliris and provides a bookend for what was a busy 2021, where in addition to advancing several of them staffed we completed financial transactions that strengthened our financial position completed the dose escalation portion of our sarcoma.
Mark Rosenblum: We completed financial transactions that strengthened our financial position, completed the dose escalation portion of our sarcoma trial.
Mark Rosenblum: added two additional patient treatment groups to our sarcoma trial, added numerous clinical trial sites to enroll patients in our sarcoma trial.
While added two additional patient treatment groups to our sarcoma trial added numerous clinical trial sites to enroll patients in our sarcoma trial activated an investigator initiated clinical trial in hematologic cancers at MD Anderson Anderson cancer Center.
Mark Rosenblum: Activated an investigator-initiated clinical trial in hematologic cancers at MD Anderson Cancer Center.
Mark Rosenblum: closed our advanced solid tumor trial, which supported our sarcoma trial expansion, and initiated a number of research collaborations.
<unk>, our advanced solid tumor trial, which supported our sarcoma trial expansion.
And initiated a number of research collaborations.
Mark Rosenblum: We believe 2021 was a successful year.
We believe 2021 was a successful year.
Mark Rosenblum: But now I'd like to spend some time talking about the future.
But now I'd like to spend some time talking about the future.
Mark Rosenblum: Our priorities for 2022 are clear. We believe that we are well-positioned, and I'd like to tell you what we plan to achieve, both with SEPA Demstat and with SP 3164. I think you'll understand why we at Solaris are excited about the future.
Our priorities for 2022 were clear we believe that we are well positioned and I would like to tell you what we plan to achieve both with <unk> and with SP 31, 64, I think you'll understand why we are hilarious are excited about the future.
Mark Rosenblum: For a long time, I've talked to you almost exclusively about Cyclademstat.
For a long time I've talked to you almost exclusively about Cyclothyme staff Cyclotome stat. As you know is a reversible protein inhibitor that targets.
Mark Rosenblum: Cyclodemstat, as you know, is a reversible protein inhibitor that targets.
Mark Rosenblum: LSD-1, an enzyme that is overexpressed in many types of cancer and is a promising target for anti-cancer drug therapy.
LSD one an enzyme that is over expressed in many types of cancer and has a promising target for anti cancer drug therapies.
Mark Rosenblum: As I've discussed in previous calls, cyclodemstat is currently the subject of two separate phase one, two clinical trials. The first trial is exploring its potential as a monotherapy treatment in two groups of sarcoma patients, mixed-load liposarcoma and FEP-rearranged sarcomas.
As I've discussed in previous calls Cyclotome status currently the subject of two separate phase one two clinical trials. The first trial is exploring its potential as a monotherapy treatment in two groups of sarcoma patients Myxoid LIFO sarcoma in FTE PV arrange sarcomas.
Mark Rosenblum: and also exploring its potential in chemotherapy combination treatment in a third type of sarcoma, Ewing sarcoma.
And also exploring its potential in chemotherapy combination treatment and a third type of sarcoma Ewing sarcoma.
Mark Rosenblum: The second trial is exploring its potential in patients with two aggressive forms of hematologic or blood cancer.
Second trial is exploring its potential in patients with too aggressive forms of hematologic or blood cancers.
Mark Rosenblum: Eclodemstat continues to advance in the clinic with patients enrolling across both clinical trials, and as we've discussed previously, we are looking forward to providing updates later this year.
And as that continues to advance in the clinic with patients enrolling across both clinical trials and as we've discussed previously we are looking forward to providing updates later this year.
Mark Rosenblum: With that said, I'd like to take the opportunity to discuss our recent acquisition involving SP3164 and how this acquisition adds additional potential above and beyond our protein inhibition program led by Cekla Dempstad.
With that said I'd like to take the opportunity to discuss our recent acquisition involving SP $31 64, and how this acquisition adds additional potential above and beyond our protein inhibition program led by cycle them stock.
Mark Rosenblum: As mentioned earlier, the assets acquired through our transaction with Dudirex form the basis of our new cancer drug.
As mentioned earlier the assets acquired through our transaction with <unk> formed the basis of our new cancer drug development program. This program is focused on targeted protein degradation of fast growing field of cancer drug research protein targeted protein degradation involve harnessing the body's natural.
Mark Rosenblum: This program is focused on targeted protein degradation, a fast-growing field of cancer drug research.
Mark Rosenblum: Protein, targeted protein degradation involves harnessing the body's natural degradation system to selectively target and eliminate disease-causing proteins. And by doing so, stop the development and progression of cancer.
<unk> degradation system to selectively target.
And eliminate disease, causing proteins and by doing so.
The development and progression of cancer.
Mark Rosenblum: This field of research has already transformed the treatment of cancer with products like BMS cell genes, Revl-Ed, and Pomelast, both protein degraders, which combined for over $15 billion in global sales in 2020, and are indicated for treatment of cancers such as non-Hodgkin's lymphoma and multiple myeloma.
This field of research has already transformed the treatment of cancer with products like BMS, Celgene, Revlimid and <unk>, both protein Degraders, which combined for over $15 billion in global sales in 2020 and are indicated for treatment of cancers, such as non Hodgkin's lymphoma and multiple myeloma.
Mark Rosenblum: We believe these early generation protein degraders are only the tip of the iceberg in the potential for protein degradation to deliver efficacious medicines that are able to overcome drug resistance and achieve a therapeutic effect with small quantities of drug. Perhaps the most exciting is the potential to use targeted protein degradations to pursue medicines targeting cancer-promoting proteins that have historically been considered undruggable.
Emma.
We believe these early generation protein degraders are only the tip of the iceberg and the potential for protein degradation to deliver efficacious medicines that are able to overcome drug resistance and achieve a therapeutic effect with small quantities of drug for.
Perhaps the most exciting is the potential to use targeted protein degradation to pursue medicines targeting cancer promoting proteins that have historically been considered undruggable.
Mark Rosenblum: Other pharmaceutical companies seem to share our vision as demonstrated by recent deal making around targeted protein degradation that reads like a who's who list of the biopharmaceutical industry. For example, last year Pfizer inked a drug development deal with Arvinas worth about $1
Other pharmaceutical companies seem to share our vision as demonstrated by recent dealmaking around targeted protein degradation that reads like a who's who list of the biopharmaceutical industry. For example, last year Pfizer, Inc to drug development deal with our venous worth.
About $1 billion.
Mark Rosenblum: Bayer acquired Vividium Therapeutics for $1.5 billion and Novartis entered into a transaction with UK-based Dunab Therapeutics worth $1.3 billion.
Bayer acquired <unk> therapeutics for $1 5 billion and Novartis entered into a transaction with UK based done add therapeutics worth $1 3 billion and.
Mark Rosenblum: And just last month, Amgen completed a $500 million multi-year drug development deal with Plexium.
And just last month, Amgen completed a $500 million multiyear drug development deal with flexible.
Mark Rosenblum: From our viewpoint, it is apparent that these drug makers see value in targeted protein degradation given the commercial success of the first generation molecular glues or protein degraders and the tremendous upside to developing new drugs targeting previously or historically undruggable targets.
Our viewpoint. It is apparent that these drugmakers see value and targeted protein degradation given the commercial success of the first generation molecular glues or protein degraders.
And the tremendous upside to developing new drugs targeting previously or historically undruggable targets.
Mark Rosenblum: But beyond the financial allure and multi-billion dollar commercial market potential, we believe that targeted protein degradation represents an excellent strategic fit for celeria.
But beyond the financial Allure in multibillion dollar commercial market potential we believe the targeted protein degradation represents an excellent strategic fit for Soliris. We believe we can harness our existing scientific expertise in gene dysregulation and protein expression and our growing clinical infrastructure to.
Mark Rosenblum: We believe we can harness our existing scientific expertise in gene dysregulation and protein expression and our growing clinical infrastructure to efficiently advance 3164 into the clinic.
Recently advanced $31 64 into the clinic.
Mark Rosenblum: Building on our optimism around 3164 is our belief that the asset will have a strong clinical safety profile and the potential to be superior from an efficacy perspective versus other comparable drugs.
Building on our optimism around $31 64 is our belief that the asset will have a strong clinical safety profile and the potential to be superior from an efficacy perspective versus other comparable drugs.
Mark Rosenblum: 3164 is an oral, small-molecule, cereblon-binding protein degrader.
$31 64 is an oral small molecule <unk> binding protein to greater risk.
Mark Rosenblum: referred to as a molecular glue because it is designed to attract or bring disease-causing proteins into proximity with an enzyme that induces targeted protein degradation.
<unk> as a molecular gloom because it is designed to attract or bring disease, causing proteins into proximity with an enzyme that induces targeted protein degradation.
Mark Rosenblum: Or, in simpler terms, it eliminates the disease-causing protein.
Or in simpler terms it eliminates the disease, causing protein.
30, <unk> hundred 64 was engineered by due to Rex.
Mark Rosenblum: from a first-generation molecular glue, avatamide, using a unique process called deuterium-enabled switching, or DECS, D-E-C-S, to create a new novel molecular entity with the potential for increased efficacy and improved safety compared to avatamide.
From a first generation molecular glu <unk> using a unique process called deuterium enabled switching or decks.
U S to create a new novel molecular entity with the potential for increased efficacy and improved safety compared to <unk>.
Mark Rosenblum: Why is this important? This is important because avatamide, also known as CC122 or Celgene 122, was widely studied in over 400 patients across 10 clinical trials.
Why is this important this is important because the <unk> also known as Cc 122, or Celgene. One two was widely studied in over 400 patients across 10 clinical trials. It showed a promising safety profile, good pharmacokinetics and importantly anti tumor.
Mark Rosenblum: It showed a promising safety profile, good pharmacokinetics, and importantly, anti-tumor activity across several cancer types with what we believe is strong data in lymphoma.
Activity across several cancer types with what we believe is strong data in lymphomas. So we believe that the considerable amount of validated published data produced in the development of <unk> will significantly help US guide $31 64 is development.
Mark Rosenblum: So we believe that the considerable amount of validated, published data produced in the development of avatamide will significantly help us guide 3164's development.
Mark Rosenblum: But let's remember that 3164 is an entirely new molecular entity with its own unique and improved characteristic and its own composition of matter patent. In fact, in preclinical animal studies, 3164 showed improved efficacy and increased antitumor activity compared to a vatavod in multiple myeloma.
But let's remember the $31 64 is an entirely new molecular entity with its own unique and improved characteristics and its own composition of matter patent in fact in preclinical animal studies $31 64 showed improved efficacy and increased anti tumor activity.
Compared to about a five in multiple myeloma.
Mark Rosenblum: Clearly, we can learn from the vast body of research surrounding nevadama.
Clearly, we can learn from the vast body of research surrounding Nevada.
Mark Rosenblum: To help us achieve this potential, DoDirect's worked with Solaris to structure a transaction that focuses today's resources on developing 3164 by backloading development milestones. In fact, the first 3164 milestone is not due until the initiation of a registration clinical trial.
To help us achieve this potential do direct work with Soliris to structure a transaction that focuses today's resources on developing 31 64 buy back loading development milestones in fact, the first $31 64 milestone is not due until the initiation of a registration clinical trial.
Mark Rosenblum: With this in mind, we are focused on advancing 3164 into the clinic as a potential treatment for hematological cancers and solid tumors in 2023. During 2022, we will prepare for an IMD submission, and we look forward to providing additional preclinical data updates later this year.
With this in mind, we are focused on advancing $31 64 into the clinic as a potential treatment for hematological cancers and solid tumors in 2023. During 2022, we will prepare for an IND submission and we look forward to providing additional preclinical data updates later this year.
Mark Rosenblum: While all this is happening, Solaris is continuing to advance the clinical development of Ceclodemstat and continuing to explore opportunities to further expand the Ceclodemstat.
While all this is happening soliris is continuing to advance the clinical development of <unk> and continuing to explore opportunities to further expand.
The second item is that development pipeline.
Speaker Change: But before I discuss further details about Solaris' future, I would like to ask Mark Rosenblum, Chief Financial Officer, to discuss our strong financial foundation, which is enabling all of this growth.
But before I discuss further details about soliris as future I would like to ask Mark Rosenblum, Chief Financial Officer to discuss our strong financial Foundation, which is enabling all of this growth.
Mark Thank.
Thank you David.
Mark Rosenblum: For the three-month period ending December 31, 2021, Solaris reported a net loss of $4.1 million, or nine cents per basic and diluted share.
For the three month period, ending December 31, 2021, Soliris reported a net loss of $4 1 million or <unk> <unk> per basic and diluted share.
Mark Rosenblum: per diluted share compared to a net loss of 1.8 million, or 10 cents per basic and diluted share for the same period in 2020.
Per diluted share compared to a net loss of $1 8 million or 10 cents per basic and diluted share for the same period in 2020.
Mark Rosenblum: The loss for the three-month period increased by $2.3 million compared to the loss for the same time span last year, primarily due to high...
The loss for the three months period.
Increased by $2 $3 million compared to the loss for the same time span last year, primarily due.
Mark Rosenblum: higher overall costs, and the absence of grant revenue in the current period.
Higher overall costs and the absence of grant revenue in the current period.
Mark Rosenblum: For the 12-month period ended December 31, Solaris reported a net loss of $12.8 million, or $0.31, per basic and diluted share.
For the 12 months period ended December 31, Soliris reported a net loss of $12 8 million or <unk> 31 per basic and diluted share.
Mark Rosenblum: compared to a net loss of $7.4 million, or $0.50 per basic share, for the same period in 2020.
Compared to a net loss of $7 4 million or <unk> 50 per basic and diluted share for the same period in 2020.
Mark Rosenblum: The loss for the 12-month period increased by $5.4 million compared to the loss for the same period last year, resulting from increased charges related to R&D personnel and higher clinical trial costs, more than offsetting lower drug development costs.
The loss for the 12 month period increased by $5 4 million.
Compared to the loss for the same period last year, resulting from increased charges related to our R&D personnel and higher clinical trial costs more than offsetting lower drug development costs.
Mark Rosenblum: Net cash used for operating activities during the 12-month period ended December 31, 2021. Total 10.2 million, essentially the same as approximately 10.3 million in the prior year.
Net net cash used for the opera for operating activities. During the 12 month period ended December 31, 2021 totaled $10 2 million essentially the essentially the same as approximately $10 3 million in the prior year.
Mark Rosenblum: During 2021, the company collected approximately $4.1 million on its outstanding grant receivable.
During during 2021, the company collected approximately $4 1 million on its outstanding Grant receivable.
Mark Rosenblum: compared to $0.8 million in the prior year.
Compared to <unk> 8 million in the prior year.
Mark Rosenblum: Research and development costs increased approximately $1.6 million, resulting from higher overall personnel costs and clinical trial expenditures, again, more than offsetting lower drug development costs.
Research and development costs increased approximately $1 6 million, resulting from higher overall personnel costs clinical trial expenditures again more than offsetting lower drug development costs.
Mark Rosenblum: General administrative costs year-to-year were essentially flat.
General and administrative cost year to year were essentially flat.
Mark Rosenblum: On December 31, 2021, our balance sheets state
On December 31, 2021, our balance sheet states.
Mark Rosenblum: that the company had $29.2 million in cash and cash equivalents compared to $11.1 million at year-end 2020. The balance sheet this year was strengthened as the company raised more than $28.3 million in 2021, primarily driven by the sale of equity securities during the first quarter of 2021.
The company at $29 $2 million in cash and cash equivalents compared to 11 point.
$1 billion at year end 2020 the.
The balance sheet. This year was strengthened as the company raised more than $28 3 million in 2021, primarily driven by the sale of equity securities during the first quarter of 2021.
Speaker Change: We believe Solaris has the financial resources to advance our ongoing clinical programs through completion and beyond. With that, I'd like to.
We believe Soliris has the financial resources to advance our ongoing clinical programs through through completion and beyond.
With that I'd like to return the call to David.
Jason Randolph: Thank you, Mark. As I mentioned earlier, the clinical programs investigating Ceclodemstat, our most advanced product candidate, are continuing to enroll. And we look forward to sharing updates from both ongoing clinical trials later this year.
Thank you Mark as I mentioned earlier, the clinical programs investigating several of them that are most advanced product candidate are continuing to enroll and we look forward to sharing updates from both ongoing clinical trials later this year.
Jason Randolph: As I've stated before, and stated often, our aim is to maximize the potential of cyclodemstat by expanding its use into new and larger indications.
As I've stated before and stated often our aim is to maximize the potential of cycle of them step by expanding its use into new and larger indications during our past discussions I have described Soliris is two pronged development strategy speed to market represented by our company sponsored sarcoma program and expand the <unk>.
Jason Randolph: During our past discussions, I have described Solaris' two-pronged development strategy, speed to market, represented by our company-sponsored Sarcoma program, and expand the market represented by the MD Anderson Cancer Center Hematologic Cancer Investigator-Initiated Trial.
Represented by the MD Anderson Cancer Center hematologic cancer investigator initiated trial.
Jason Randolph: and as well as the continued exploration into additional larger market indications.
And as well as the continued exploration into additional larger market indications.
Jason Randolph: With this in mind, we are actively researching other promising drug combinations where Ceclodemstat can address large unmet medical needs. We are also investigating the impact of Ceclodemstat's scaffolding inhibition properties to identify cancer indications where the drug can improve treatment options.
With this in mind, we are actively researching other promising drug combinations. We're cycling stack can address large unmet medical needs. We're also investigating the impact of <unk> scaffolding inhibition properties to identify cancer indications, where the drug can improve treatment options.
Jason Randolph: And as we announced last year, helping in these efforts is the research partnership established with the Cancer Epigenetics Institute at Fox Chase Cancer Center.
And as we announced last year, helping in these efforts is the research partnership established with the cancer Epigenetics Institute at Fox Chase Cancer Center.
Jason Randolph: one of several prestigious cancer hospitals and research centers that have joined the growing list.
One of several prestigious cancer hospitals and research centers that have joined the growing list of those involved in our ongoing clinical trials or helping our search for new opportunities to expand the utility of <unk>.
Jason Randolph: of those involved in our ongoing clinical trials or helping us search for new opportunities to expand the utility of cyclodemstats.
Jason Randolph: As I said earlier today, these are exciting times for Solaris, and as Mark just informed you, we reported slightly over $25 million in cash and cash equivalents at the end of last year.
As I said earlier today. These are exciting times for Soliris and as Mark just informed view, we reported slightly over $25 million in cash and cash equivalents at the end of last year.
Jason Randolph: And we are looking forward to building on our current momentum as we continue into 2022. I would now like to take questions. Joining me for the Q&A portion of this call is Mark Rosenbloom.
And we're looking forward to building on our current momentum as we continue into 2022.
I would now like to take questions. Joining me for the Q&A portion of this call is Mark Rosenblum.
Mark Rosenbloom: Dr. Nadeem Mirza, Senior Vice President of Clinical Development, and Dr. Daniela Santiestima, Director of our new Targeted Protein Degradation Program. With that, I will now open the
Nadeem Mirza senior Vice President of clinical development and Dr. Daniela <unk> the record director of our new targeted protein degradation program with that I will now open the call to your questions.
Speaker Change: As a reminder, to ask a question, you will need to press star 1 on your telephone. Again, that is star 1. To withdraw a question, press the pound key.
As a reminder to ask a question you will need to press star one on your telephone again that is star one to me.
Your question press the pound key.
Speaker Change: Your first question comes from the line of Ahu Demir of Lidingberg, Salmon. Your line is open.
Your first question comes from the line of AHU Demir.
Ladenburg Thalmann your line is open.
Good afternoon, and thank you for taking my question.
Ahu Demir: My first question will be on the 3164 program. We are looking forward for this program to advance to the clinic. In the meantime, I know we are looking for some preclinical data. I'm curious if you could elaborate more on what type of data we are going to see and when do you plan to disclose those data? Will it be around a conference? Just curious if you could give a bit of color on that.
Mike.
On the 31 64 program. We are looking forward for this program to advance to the clinic in the meantime, I know, they're looking for some preclinical data.
If you could elaborate more on.
What type of data, we are going to see and then do you plan to disclose those.
Data will appear on the comp ramp just curious if you could give a bit color on that.
Ahu Demir: Ahu, it's good to hear from you. This is David. Thanks for joining the call.
AHU, it's good to hear from you. This is David thanks for joining the call.
Ahu Demir: Um, let me let me make a couple of comments and then turn it over to Daniela.
Let me, let me make a couple of comments and then turn it over to Daniela.
Daniela Santiestima: When we're very excited about acquiring 3164 and we really feel it's a diamond in the rough, we purchased the asset from Dudirex and they had done a minimal amount of development work.
We're very excited about acquiring $31 64.
And we really feel it's a diamond in the rough we partnered while we purchased the asset from <unk> and they had done a minimal amount of development work.
Daniela Santiestima: And when we took it over, we realized that while we were convinced.
And when we took it over we realized that while we were convinced that the story was very sound.
Daniela Santiestima: the story was very sound, you know, the work, you know, Revlimid was there, Avatamide, had great comparable data to Revlimid.
Revlimid was there a atomized had great comparable data to Revlimid and.
Daniela Santiestima: and 3164 had great data compared to evitamide, we were sold. But we also knew that the marketplace was going to want to see more preclinical data, more traditional preclinical data that looked at 3164 in combination with other drugs, in vivo models, in other indications other than just multiple myeloma. And so those are the types of studies that we're working on right now.
360, <unk> had great data compared to about <unk>, we were sold but we also knew that the marketplace was going to want to see more preclinical data more traditional preclinical data that looked at $31 64 in combination with other drugs in vivo models in other indications other.
And then just multiple myeloma and so those are the types of studies that we're working on right now.
Speaker Change: Daniella is deep into planning those studies, and she might want to comment a little bit about where we're focusing, and I will share with you that as soon as the data is available, we're looking forward to getting it out, and it'll probably be, you know, probably third, late third, fourth quarter this year. But Daniella, any additional comments?
Daniela is deep into planning those studies and she might want to comment a little bit about where we're focusing.
I will share with you that as soon as the data is available we're looking forward to getting it out and it will probably be.
Third late third fourth quarter, this year, but daniela any additional comments.
Daniella: Yeah, thank you, David. And thanks also for the question. Like David said, we are really excited.
Yes, Thank you David and Thanks also for the question.
David said, we are really excited.
Daniella: planning a variety of different studies to show why 3164 has so much potential. So, we'll be doing, you know, your traditional in vitro work looking at the profile of proteins degraded. We'll look at in vivo models, as David said, both in hematological indications and solid tumors as a single agent in combination with standard of care agents. And then we're also going to be exploring the immunomodulation that's been recorded with these types of drugs.
Planning a variety of different any if so why 31 64 has so much potential and there will be doing your traditional in vitro work looking at the profile of protein integrated well look at in vivo models as David said.
In Hematological indications in solid tumors.
And in combination with standard of care agent.
And then we're also going to be exploring that immuno modulation that been recorded with these types of drugs.
Speaker Change: So yeah, like David said, looking forward to presenting the data third quarter, fourth quarter of this year, you can anticipate and maybe guess that we'll be trying to present at ASH this year as we start to generate some of the preclinical data in the HEIM space.
Yes, like David said looking forward to presenting the data third quarter fourth quarter of this year.
And then maybe get back will be trying to present at ash. This year as we start to generate some of the preclinical data in the Q.
Okay.
Speaker Change: Sounds great, thank you. I have one more follow-up question, that would be...
Great. Thank you I have one more follow up question.
Jim that would be.
Speaker Change: I know we talked about the evidence might show some data in the liver cancers multiple myeloma and you also mentioned some particular interest in the solid tumor arena. Are we going to see any specific towards solid tumors for the preclinical data that will be disclosed this year?
I know you talked about.
I know Mike showed some data in the liver cancer multiple myeloma and you also mentioned some parts to the interest in this call. The tumor arena are we going to see any specific towards solid tumors for the preclinical data that will be disclosed this year.
Yes.
<unk>.
Speaker Change: Dave, yeah, I can take this one. Yeah, please.
Dave Yes.
I can take this one please.
Please.
Dave: So yeah, we're exploring the heme space because that's really where evitamines, which are an improved version of evitamines for great activities. But like you said, they also support solid tumors. And we'll also be doing that. We do believe 3164 is differentiated from other molecular glues.
So yes.
One vacant spaces.
That's really where our bottom line.
Which are an improved version of that in mind, so great activity, but like you said they also reported solid tumor.
We will also be doing that we do believe 31 before is differentiated from other molecular glues.
Dave: and we'll have promising activity in a variety of solid tumors and so we do have a short list that we're actively looking into and should be generating some data in that space this year as well.
And we will have.
Promising activity in a variety of solid tumor.
So we do have a shortlist that were actively looking.
And should be generating some data in that space this year as well.
Speaker Change: Thank you. This is very helpful. I'll hop back on the queue. Thank you.
Thank you that's very helpful I'll hop back on the queue.
Speaker Change: Thank you. Your next question comes from Hunter Diamond with Diamond Equity.
Thank you. Your next question comes from Hunter Diamond.
Gentlemen, ladies.
Hunter Diamond: Hi everyone, hope everyone's doing well. So I had a couple of questions. The first one was, can you comment more on the recently filed form fours?
Hi, everyone and hope everyone is doing well so I had a couple of questions.
First one was can you comment more on the recently filed form fours.
Hunter Diamond: Hunter, this is David. Good to hear from you. Thank you for joining the call.
Hunter. This is David good to hear from you. Thank you for joining the call.
David Arthur: Yes, both Mark Rosenblum and I filed Form 4s today. We were able to participate in a company-wide program that allowed us to
Yes, both Mark and Mark Rosenblum <unk> filed form fours today.
We were able to participate in a company wide program that allowed us to.
David Arthur: purchase stock with a portion of our annual bonus.
Purchase stock with a portion of our annual bonus.
David Arthur: And as CEO of Solaris, and I'm sure you're aware of this, I have very limited opportunities to purchase stock.
And as CEO .
Soliris and I'm sure you're aware of this I have very limited opportunities to purchase stock.
David Arthur: You know, there's the blackout periods, I have to wait for an open window, I have to make sure that I'm not in possession of material non-public information, and this program, programs like our employee stock purchase program, which I participate in, and, you know, and other activities, if I have an opportunity to participate, I do. So I, as I've said to a number of people, and I talk about in all of our calls, I'm very bullish on.
There is a there is the blackout periods I have to wait for an open window I have to make sure that I'm not in possession of material nonpublic information.
And this program programs like our employee stock purchase program, which I participate in it.
And.
And other activities.
If I have an opportunity to participate I do.
So I as I've said to a number of people and I talk about in all of our calls I'm very bullish on.
David Arthur: on Solaris as a company. I think the, you know, Seclademstat has potential. I'm looking forward to the readouts in the middle of the year. I couldn't be more excited about the acquisition of 3164. When the opportunity presented itself to take the maximum opportunity available to purchase some stock at today's prices, you know, I jumped all over it.
On Soliris as a company I think.
<unk> has potential I'm looking forward to the readouts in the middle of the year I Couldnt be more excited about the acquisition of $31 64, and when the opportunity presented itself.
Take the maximum opportunity available to purchase some stock at today's prices jumped all over it.
Speaker Change: Great, no, I appreciate the clarification. It makes perfect sense. My other question was, and maybe it's more for Mark, talking about, you know, the cash burn in the runway, you know, with the new asset.
Great No I appreciate the clarification and it makes perfect sense. My other question was maybe it's more for Mark.
Talking about the cash burn and the runway with the new asset.
Well.
<unk>.
Mark: Our cash burn, as you can see, for most every quarter in the last year, even a little bit more, is about $3.5 to $3.8 million per quarter.
Our cash burn as you can see for most every quarter.
Last year, even a little bit more is about.
Three five to $3 $8 million per quarter.
Speaker Change: The studies that are required, my understanding of the studies, and David can provide a little bit of color commentary here.
The studies that are required my understanding of the studies and David can provide a little bit of color commentary here my understanding of the studies that we are initially.
Speaker Change: My understanding of the study is that we are initially performing them on 3164, and the ongoing studies, of course, on secular DEMSTAT, we've already budgeted for. It's already been in our cash runway. The 3164 activities are largely in the beginning all tolerable by our current, you know, by our current cash flow. We can handle them. They're not all that expensive until we get into the future a little bit more.
Initially performing.
$31 64, and the ongoing studies of course on <unk>, we've already budgeted for its already been in our cash runway the $31 64.
Activities are largely in the beginning.
All tolerable by our current.
Our current cash flow, we can handle them. They are not all that expensive until we get into the future a little bit more.
Speaker Change: But right now, it seems as though we can fit them in.
What.
Right now we've seen it seems as though we can we can fit them in.
So David do you want to.
Speaker Change: But Mark, I think you hit the nail on the head. You can look at it mathematically and say, we've just reported.
Mark I think you hit the nail on the head you can look at it mathematically and say, we've just reported $29 million and change in cash and cash equivalents at the end of last year, and we burn 1 million to $1. Three a month you can do the math and come up with the one number and then you can look at the fact that come <unk>.
Speaker Change: 29 million and change in cash and cash equivalents at the end of last year. And we burn a million, two, a million, three a month. You can do the math and come up with one number and then you can look at the fact that come second half of this year, we're gonna get data releases on Ewing's sarcoma and that data can take us in one direction or it can take us in another. So, we strategically.
Half of this year, we're going to get data releases on Ewing sarcoma and that data can take us in one direction or it can take us on another so.
We strategically.
Speaker Change: The second half of this year and the first half of next year is going to be exciting times for Solaris, but what we feel good about is we're sitting on enough cash runway to cover us during that period and give us some operating space.
The second half of this year in the first half of next year is going to be exciting times for <unk>, but what we feel good about is we're sitting on enough cash runway to cover us in during that period and give us some operating space.
Speaker Change: Great, exactly. And that's what you want to hear in this risk-off environment. So the next question was, you know, the targeted protein degradation is obviously a huge market, you know, multi-billionth, and you announced some of the, you know, deals on the call. Does that worry you in terms of, you know, how crowded it is, or are there a lot of competitors in this space?
Great exactly and that's what you want to hear in this risk off environment.
The next question was the targeted protein degradation is obviously, a huge market multi billions and you announced some of the deals on the call.
Does that worry you in terms of how crowded it is or are there a lot of competitors in this space.
Speaker Change: Um, you know, Hunter, let me take a crack at that first, and then I'll see if Daniela wants to follow on.
Let me take a crack at that first and then I'll see if Daniela wants to follow on.
Speaker Change: No, it doesn't bother me at all. In fact, it makes me feel good about our decision. Let's face it, if we were entering a space with no competition, it would tell me that A, we made a bad choice, or B, it's because no one wants to be there, or B, it's such a difficult space, nobody wants to be in it.
No. It doesn't bother me at all in fact, it makes me feel good about our decision let's face. It. If we were entering this space with no competition. It would tell me that hey, we made a bad choice or be it because no one wants to be there or be it such a difficult space nobody wants to be in it. So the fact that.
Speaker Change: So the fact that we're pursuing, we're entering a space and we're entering it with a drug where we hope to be planned to be in the clinic next year.
We're pursuing we're entering our space, we're entering it with a drug where we hope to be planned to be in the clinic next year.
Speaker Change: And you look at the fact that the other people in this space read like a who's who of the biopharmaceutical industry.
And you look at the fact that the other people in this space read like a who's who of the biopharmaceutical industry.
Speaker Change: I'm pretty excited. I mean, we're in the game with some really good players and based on the data we've seen about 3164, I think we have a very competitive product and we're looking forward to getting some additional data.
I am pretty excited I mean, we are we're in the game with some really good players in and based on the data we've seen about.
$31 64, I think we have a very competitive product and we're looking forward to getting some additional data.
Speaker Change: out into the marketplace to help support that knowledge that we have.
Out into the marketplace to help support that that that knowledge that we have.
Speaker Change: Great. No, I appreciate the color. In terms of, I guess, evitamide, you discussed that a lot with 3164. Can you just explain sort of the logic why that's always mentioned?
Great No I appreciate the color and.
In terms of I guess <unk> you discuss that a lot with 364 can you just explain sort of the logic why that's always mentioned.
Speaker Change: You know, Daniela, would you like to take that and tell a little bit about the 3164 nevadamide story?
No Daniella would you like to take that until a little bit about the $31 64 in Nevada might story.
Daniela Santiestima: Yeah, yeah, happy to. And I'll just add to your previous question, Hunter, that in addition to what David said, the targeted protein degradation phase is still relatively new. So if you look at where all the programs are, most of them are actually in phase one development with actually over 70% being in preclinical or discovery phase.
Yeah, Yeah happy to and I'll just add to your previous question I'm Terry that.
In addition to what David said the targeted protein degradation still.
Still relatively new so if you look at where all of the programs are most of them are actually.
As one development with actually over 70% being in preclinical or discovery.
Daniela Santiestima: So while there is competition, and like David said, it's good to enter a space that others think is attractive, we're in a great position in terms of timing with 3164.
So while there is competition and like David said.
Great to enter space that others think is attractive.
We're in great position in terms of timing with 31 before.
Daniela Santiestima: So then moving on to your next question, like David mentioned in his call, what we have with 3164 is an improved version of Vatimibe.
And then moving onto your next question like David mentioned in his call of what we have with 31 64.
Proved version of that in mind.
Daniela Santiestima: Avatamide, not to get too sciency, but it exists as a racemic mixture, so two enantiomers, but it's only one of those enantiomers that's actually the active species. And that means that it's only one of the enantiomers that's having that anti-cancer effect that you want in an anti-cancer drug.
With that in mind not to get too sciences.
Does that make next year.
Two in the ancillary, but it's only one of those Amanda that's actually the EC and that means that it's only one of the <unk>.
Having that anti cancer effect that you want in an anti cancer drugs.
Daniela Santiestima: one half of the drug is not contributing any therapeutic activity.
One half of the drug is not contributing any therapeutic activity and so what we have with 31 64 purified the active species that has that anti cancer activity and Thats why when we go into preclinical models, we see improved therapeutic activity when we compare it to.
Daniela Santiestima: And so what we have with 3164 is we've purified the active species that has that anti-cancer activity.
Daniela Santiestima: And that's why when we go into preclinical models, we see improved therapeutic activity when we compare to evitamide. And this is important because like David said, evitamide already in clinics showed a nice safety profile.
And this is important because like David said <unk> already in clinic.
Nice safety profile showed good therapeutic activity in lymphomas and solid tumors.
Daniela Santiestima: showed good therapeutic activity in lymphomas and in solid tumors.
Daniela Santiestima: And so if we can show an improvement over a drug that already showed promising activity in clinics.
We can show an improvement over a drug that already has shown promising activity in clinic.
Daniela Santiestima: it would be great. And that's why we were really excited about 3164's potential. And to your question, that's why it's compared to evitamide, an improved version of it.
It would be great and Thats why we are really excited about 31 64, its potential and to your question Thats why its compared to about a much improved version of it.
Does that help.
Speaker Change: Absolutely. No, thank you. That's a great, great color on that. So the last question, and I'll open the line for other investors, in terms of upcoming milestones, can you just kind of pinpoint, you know, what you view as the main ones and what you view investors should be monitoring the next 12 months?
Absolutely no. Thank you that's great.
Good color on that so the last question and then I'll open the line for other investors in terms of upcoming milestones can you just kind of pinpoint what you view as the main ones and what your investors should be monitoring the next 12 months.
Speaker Change: Yeah, Hunter I'd be happy to, you know, we've been talking a lot about clinical trial enrollment and in the sarcoma and in the hematologic study and now we're talking about 3164, so it's a pretty full plate.
Yes Hunter.
Be happy too we've been talking a lot about clinical trial enrollment in the sarcoma in the hematologic study and now we're talking about 31 64, so it's a pretty full plate.
Speaker Change: So, let's start with seculodemstat. Enrollment is continuing. We have three patient populations, Ewing, sarcoma.
<unk>.
So I'll start with cycle of them stopped enrollment is continuing.
Three patient populations Ewing's sarcoma.
Speaker Change: We have mixed liposarcoma, we have FVT rearranged sarcomas.
Have mixed with LIFO sarcoma, we have FCT rearrange sarcomas.
Speaker Change: And we are looking to report out some interim data in mid-year third quarter ish
And we are looking to report out some interim data in mid year third quarter ish.
Speaker Change: You know, we have patients that we're actively treating. We just need to see, you know, we need to get some months under our belt. These are, these are diseases where the real benefit to patient is to increase their progression-free survival. And to get that data, you've got to get patients on treatment and let them stay on treatment for a while.
We have patients that were actively treating and we just need to see and we need to get some months under our belt. These are these are diseases, where the real benefit to patients is to increase their progression free survival and to get that data you've got to get patients on treatment and let them stay on treatment for a while.
Speaker Change: So that's coming mid-year. And now what we've added to that list of milestones is the 3164.
<unk>.
So thats coming mid year and now what we've added to that list.
A list of milestones is the $31 64 portfolio.
Speaker Change: portfolio of data. And as Daniela said, we've, we've, you know, we brought the drug in house, we've
Portfolio of data and as Daniela has said we would be.
What the drug in house we've.
Speaker Change: Spent a lot of time building our our early development plans We have a list of studies that we think is exactly the type of information that not only we want to see but that the marketplace wants to see and potentially strategic partners want to see and we're hoping to complete that work in late q3 early q4 and start getting it out and
Spent a lot of time building out our early development plans, we have a list of studies that we think is exactly the type of information that not only we want to see but that the marketplace wants to see and potentially strategic partners want to see and we're hoping to complete that work in late Q3.
Q4 and start getting it out.
Speaker Change: potentially at conferences, potentially at press releases. And so the second half of this year is gonna be pretty exciting.
Potentially conferences potentially press releases and so the second half of this year is going to be pretty exciting.
Speaker Change: Great. I look forward to the continued progress. And again, thank you for taking my questions. Thank you for taking the
Great look forward to the continued progress and again, thank you for taking my questions.
Thank you for taking the time to join the call take care.
Speaker Change: Once again, if you would like to ask a question, please press star 1 on your telephone.
Once again, if you would like to ask a question. Please press star one on your telephone.
Yes.
There are no further questions.
Speaker Change: Okay. Thank you. Thank you, Ashley. So let me make a few concluding remarks. As you've heard from today's discussion, we view this year as a year of optimism.
Okay. Thank you.
Thank you Ashley So let me make a few concluding remarks.
You have heard from today's discussion we view this year as a year of optimism.
Speaker Change: Given our expansion into targeted protein degradation, our continuing clinical development of ceclovimstat, our continued strong financial footing, and as, you know, we discussed with.
Given our expansion into targeted protein degradation, our continuing clinical development second with them Stat, Our continued strong financial footing and as we discussed with.
Speaker Change: Hunter's question the value building opportunities and and data points in in the future. We think it's going to be a great year for hilarious
Hunters question, the value building opportunities and data points in the future, we think it's going to be.
Great year.
Hilarious.
Speaker Change: I look forward to working with my management team and our board of directors to execute our business and clinical strategy that has, as I mentioned, the potential to build Solarius Pharmaceuticals into an anti-cancer drug development powerhouse. We really believe that.
I look forward to working with my management team and our board of directors to execute our business and clinical strategy has as I mentioned the potential to build soliris pharmaceuticals into an anti cancer drug development powerhouse, we really believe that supporting all of this is the dedication of our employees and the support of our stakeholders with.
Speaker Change: Supporting all of this is the dedication of our employees and the support of our stakeholders. Without all of them, Solaris would not be where it is today.
All of them Soliris would not be where it is today, we look forward to embarking on what we believe will be a productive year. We appreciate your continued support.
Speaker Change: We look forward to embarking on what we believe will be a productive year and we appreciate your continued support.
Speaker Change: Thank you everyone for your time and attention today, and I extend my sincerest wishes for good health to all. Thank you.
You everyone for your time and attention today and I extend my sincerest wishes for good health to all.
Yes.
Speaker Change: This concludes today's conference call. You may now disconnect.
This concludes today's conference call you may now disconnect.
Great.
Okay.
Okay.
Thank you.
Okay.
[music].
Speaker Change: ?? ?? ?? ?? ??
Sure.
[music].
Speaker Change: Thanks for watching!
Speaker Change: ? ? ? ? ? ? ? ? ? ? ? ?
Speaker Change: ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?
[music].
Speaker Change: ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?
Speaker Change: .
Speaker Change: ♪ ♪ ♪ ♪ ♪ ♪ ♪ ♪ ♪ ♪ ♪ ♪ ♪ ♪ ♪
Speaker Change: ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ??
[music].
Speaker Change: ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?
Speaker Change: ? ? ? ? ? ? ? ?
Speaker Change: ______________
[music].
Speaker Change: ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?
Speaker Change: you