Q1 2022 Chemomab Therapeutics Ltd Earnings Call

May 12, 2022

Yes.

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Greetings and welcome to the Chemo maps first quarter 2022 earnings call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad as a reminder, this conference.

Greetings and welcome to the ChemoMaps First Quarter 2022 Earnings Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I'd now like to turn the conference over to your host, Barbara Lindheim, Consulting Vice President of Strategic Communications for ChemoMaps. Thank you. You may begin.

Is being recorded I'd now like to turn the conference over to your host Barbara Lean time consulting Vice President Chief Communications for Chemo Ma'am. Thank you you may begin.

Welcome to the acumen that therapeutic 2022 first quarter conference call. Thank you for attending I am Barbara in time consulting Vice President of Strategic Communications Act you know that when you meet your J R. J I'll publish our chairman and CEO, Don Marvin CFO Chi.

Welcome to the TimaMap Therapeutics 2022 First Quarter Conference Call. Thank you for attending. I am Barbara Lindheim, Consulting Vice President of Strategic Communications at TimaMap. With me today are Dale Post, our Chairman and CEO , Don Marvin, and I'm going to be

CFO , Chief Operating Officer, and Executive Vice President, Dr. David Wiener, Interim CMO, and Dr. Adi Moore, our Co-Founder and Chief Scientific Officer.

Operating officer, and executive Vice President, Dr. David Wiener interim CMO and Doctor out even more our co founder and Chief Scientific Officer.

Before turning the call over to Dale, please take note of our forward-looking statement.

Before turning the call over to Dale. Please take note of our forward looking statements.

Today's call may contain forward-looking statements, which may be identified by words such as may, could, will, expect, intend, plan, and other similar words and expressions.

Today's call May contain forward looking statements, which may be identified by words, such as may could well expect intend plan and other similar words and expressions.

All forward-looking statements made today are based on management's current expectations, assumptions, and beliefs about our business and the environment in which we operate. These statements are subject to risks and uncertainties that could cause our actual results to materially differ from those expressed or implied on today's call.

Forward looking statements made today are based on management's current expectations assumptions and beliefs about our business and the environment in which we operate these statements are subject to risks and uncertainties that could cause our actual results to materially differ from those expressed or implied on today's.

Carl.

Listeners should not place undue reliance on forward-looking statements and are encouraged to review our earnings press release that we issued this morning, together with our SEC filings

Listeners should not place undue reliance on forward looking statements and are encouraged to review our earnings press release that we issued this morning together with our SEC filings.

for a more complete discussion of factors that could cause our actual results to differ materially from those expressed or applied in forward-looking statements.

For a more complete discussion of factors that could cause our actual results to differ materially from those expressed or implied in forward. Looking statements. You can make a comprehensive list of those factors under the heading risk factors contained in our annual report on Form 10-K, together with factors under similar heading.

You can make a comprehensive list of those factors under the heading Risk Factors, contained in our annual report on Form 10K, together with factors under similar headings in the other reports and materials we file with the SEC.

And the other reports and materials, we filed with the SEC, except as required by federal Securities laws Shimon that does not undertake to publicly update or revise any forward looking statements.

Accepted as required by Federal Securities Laws, TimaMap does not undertake to publicly update or revise any forward-looking statements subsequent to the date made as a result of new information, future events, changing circumstances, or for any other reason. Let me now turn the call over.

Subsequent to the date made as a result of new information future events changing circumstances or for any other reason, let me now turn the call over to Dale.

Welcome to the Keemabab conference call covering the first quarter of 2022. It's just been two months since our last conference call and I'm pleased to report that we have been making good progress in refining and implementing the revisions to the CM 101 clinical program that we outlined in March.

Welcome to the human about conference call covering the first quarter of 2022, it's just been two months since our last conference call and I'm pleased to report that we have been making good progress in refining and implementing the revisions to they see them. One on one clinical program that we outlined in March.

CM-101 is a first in class monoclonal antibody that neutralizes CCL-24, a soluble protein implicated in both fibrosis and inflammation.

So I am 101 is a first in class monoclonal antibody that neutralizes tcl twenty-four a soluble protein implicated in both the fibrosis and inflammation we.

We are currently developing CM 101 for the rare disease indications of primary sclerosis and colonitis, or PSD, and systemic sclerosis, or FS.

We are currently developing the am 101 for the rare disease indications of primary sclerosing, cholangitis, or PSC and systemic sclerosis or S. S C.

as well as evaluating other potential clinical indications where its multiple mechanisms of action at the confluence of fibrosis and inflammation could be valuable.

As well as evaluating other potential clinical indications, where it's multiple mechanisms of action at the confluence of fibrosis and inflammation could be valuable.

Our interim PMO, David Wiener, will have more to say on our clinical progress shortly.

Our interim CMO, David Wiener will have more to say on our clinical progress shortly.

There are several areas of notable developments in the first quarter. We named Jack Lawler, Vice President of Global Clinical Development Operations. Jack, who is based in the US, is a tremendous addition to our clinical team, bringing us more than 20 years of diverse clinical drug development experience.

There are several areas of notable developments in the first quarter, we named Jack Lawlor, Vice President of Global clinical development operations, Jack who is based in the U S is a tremendous addition to our clinical team, bringing us more than 20 years of diverse clinical drug development experience.

Jack's deep knowledge of clinical trial operations is already proving invaluable working with both our existing clinical trial staff in Israel and with additional essential team members he is bringing on board, including in the United States.

<unk> deep knowledge of clinical trial operations is already proving invaluable working with both our existing clinical trial staff in Israel and with additional with Central team members. He is bringing on board, including in the United States.

Jack will be playing a pivotal role in advancing our clinical development objectives and we are delighted to have someone with his expertise and hands on knowledge in this important position.

Jack will be playing a pivotal role in advancing our clinical development objectives, and we are delighted to have someone with his expertise and hands on knowledge in this important position.

During the quarter, we presented data at two scientific meetings. At the International Rheumatology Conference in Israel, our CSO, Dr. Adimor, presented preclinical data on CM-101 as a possible treatment for systemic sclerosis with the potential to impact inflammation, fibrosis, and endothelial damage.

During the quarter, we presented data at two scientific meetings at the International Rheumatology Conference in Israel, Our CSO. Dr. D. Mor presented preclinical data on <unk> hundred one as a possible treatment for systemic sclerosis, with the potential to impact inflammation fibrosis and endothelial damage.

Data from patient samples demonstrated that the soluble protein, PCL24, the target of CM101, is highly expressed in samples from systemic sclerosis patients compared to healthy individuals.

Different patient samples demonstrated that the soluble protein Tcl 24, the target up to see them. One on one is highly expressed in samples from systemic sclerosis patients compared to healthy individuals.

CCL-24 levels also correlated with fibrotic markers and disease progression, and in a well-established experimental systemic sclerosis model, CM-101 profoundly reduced skin and lung fibrosis.

Tcl 24 levels also correlated with fibrotic markers and disease progression and in a well established experimental systemic sclerosis model C. I'm wondering one profoundly reduced skin and lung fibrosis.

Our scientific collaborator, Professor Francisco Delgado, a respected scleroderma key opinion leader at the University of Leeds, presented CM1-101 data at the Seventh Annual Systemic Sclerosis World Congress.

Our scientific collaborator Professor Francisco they'll go to a respected scleroderma key opinion leader at the University of Leeds presented the them on one on one data at the seventh annual systemic sclerosis World Congress.

The data supports the role of CCL24 as a novel biological target for systemic sclerosis, demonstrating that systemic sclerosis patients have elevated serum levels of CCL24. Furthermore, high CCL24 serum levels were correlated with disease activity and worse prognosis in these patients as reflected by high fibrotic activity and deterioration of lung function over time.

The data supports the role of CCL 24, as a novel biological target for systemic sclerosis, demonstrating that systemic sclerosis patients have elevated serum levels of C. C. All 24.

Furthermore, high C. C. L 24 serum levels were correlated with disease activity and worst prognosis in these patients as reflected by high fibrotic activity and deterioration of lung function over time.

This provides additional evidence that CM-101 is addressing an important biological target in systemic growth.

This provides additional evidence that see them one on one is addressing an important biological target in systemic sclerosis.

These data contribute to our optimism that CM101 could be a valuable new therapy for the treatment of systemic sclerosis, a progressive and lethal disease that currently lacks effective therapy.

These data contribute to our optimism that see I'm wondering one could be a valuable new therapy for the treatment of systemic sclerosis, a progressive and lethal disease. They currently lacks effective therapies.

During the quarter, we also participated in the annual Oppenheimer Health Care Conference and the Cantor Fitzgerald Rare Orphan Disease Summit.

During the quarter. We also participated in the annual Oppenheimer Healthcare conference and the Cantor Fitzgerald rare orphan disease stomach.

Now, let me turn it over to Dr. David Wiener, who is leading our clinical team as we focus on advancing our clinical development program for CM101. Recall that our aims in the program are to optimize the overall clinical development plan for CM101 by, first, decreasing overall development risk, and second, maximizing the clinical data obtained to facilitate clinical decision-making and support advancement to registration trials.

Now, let me turn it over to Dr. David Wiener, who is leading our clinical team as we focus on advancing our clinical development program for see them one on one.

Recall that our Ames in the program are to optimize the overall clinical development plan for <unk> 101, right first decreasing overall development risk and second maximizing the clinical data obtained to facilitate clinical decision, making and support advancement to registration trials.

David.

Good morning, let me start by taking a moment to recall the three key elements of our C. M. One O one clinical development program, one expanding our effort in PSC with another large clinical trial that adds an important dose finding component.

Good morning. Let me start by taking a moment to recall the three key elements of our SAM 101 clinical development program.

1. Expanding our effort in PFC with an enlarged clinical trial that adds an important dose finding component.

Two, establishing biological and clinical proof-of-concepts for CM-101 in systemic sclerosis.

To establishing biological and clinical proof of concept for the am 101 in systemic sclerosis.

and three, completing enrollment in our safety, PK, and biomarker liver fibrosis study in NASH patients, with final readouts expected near the end of this year.

And three completing enrollment in our safety PK and biomarker of liver fibrosis study in Nash patients with final Readouts expected near the end of this year.

Let me begin with the liver fibrosis trial. I'm pleased to report that patient enrollment in this study is now complete and we are on target for a final day to read out in the fourth quarter.

Let me begin with the liver fibrosis trial I'm pleased to report that patient enrollment in this study is now complete and we're on target for a final data readout in the fourth quarter.

The data readout in this study will include safety and tolerability data to support future development and deeper insights into CM-101's mechanism of action, providing additional data on the anti-inflammatory and anti-fibrotic activity of CM-101 in liver disease.

The data read out in this study will include safety and Tolerability data to support future development.

And deeper insight into see him 100 one's mechanism of action.

<unk> additional data on the anti inflammatory and anti fibrotic activity.

I am 101 and liver disease.

Additionally, a key objective of this study was to explore the safety and drug exposure achieved with our sub-Q formulation.

Additionally, a key objective of this study was to explore the safety and drug exposure achieved with our sub Q formulation and.

And we believe the early completion of this study should be sufficient to achieve this purpose.

providing us the pharmacokinetic and tolerability data needed to assess our next steps in the development of the current subcutaneous formulation of CM-101.

Providing us the pharmacokinetic and Tolerability data needed to assess our next step in the development of the current subcutaneous formulation of <unk> hundred one.

Turning to P. S C.

The trial is currently recruiting and dosing patients, and we are expanding the number of clinical trials sites.

The trial is currently recruiting and dosing patients and we are expanding the number of clinical trial sites.

We have ongoing recruitment of patients in Israel, the UK, and at new clinical sites in Germany.

We have ongoing recruitment of patients in Israel, the U K and that new clinical sites in Germany.

New clinical sites in the US and Spain are expected to start patient enrollment shortly. And we anticipate that these additional sites will be open and actively enrolling patients before the end of the second quarter. Regarding the revised study design in PSC, we will be adding additional dose finding cohorts to this study to ensure that we have the data needed to select the optimal dose for later stage trials.

New clinical sites in the U S and Spain are expected to start patient enrollment shortly and we anticipate that these additional sites will be open and actively enrolling patients before the end of the second quarter regarding the revised study design and P. F E. We will be adding additional dose finding.

Cohort to the study to ensure that we have the data needed to select the optimal dose for later stage trial.

We expect to begin enrolling patients in the lower dose cohort later this year and anticipate being able to open a higher dose cohort to patient enrollment in early 2023.

We expect to begin enrolling patients in the lower dose cohort later this year.

And anticipate being able to open a higher dose cohort the patient enrollment in early 'twenty two 'twenty three.

Finally, we are also adding an open label extension to the trial to evaluate the safety Tolerability and durability of effect of the am 101 over longer treatment duration.

Finally, we are also adding an open label extension to the trial to evaluate the safety, tolerability, and durability of effective CM-101 over longer treatment duration.

As we also noted, we will be performing an interim analysis of the currently enrolling dose cohort in the PSD study with an expected readout in the second half of this year. The purpose of this interim analysis will be first to evaluate the safety of the Q3 weekly administration of 10 milligrams per kilogram of CM-101 to support advancement to the planned higher dose of 20 milligrams per kilogram.

As we also noted we will be performing an interim analysis of the currently enrolling dose cohort and the PSC study with an expected readout in the second half of this year. The purpose of this interim analysis will be first to evaluate the safety of the Q3 Weekly administration.

10 milligrams per kilogram of sea M. One O one to support advancement to the planned higher dose of 20 milligrams per kilogram.

And second, to assess the observed variability in serum biomarkers and clinical biochemistries in order to confirm the planned sample sizes for the CM101 dose COPA.

And second who.

That's the observed variability in serum biomarkers and clinical biochemistry in order to confirm the planned sample sizes, so to see him one O one dose cohorts.

turning to our phase 2 systemic sclerosis trial.

Turning to our phase two systemic sclerosis trial.

As we discussed on our call in March, we are focusing the goals for this trial towards establishing biological and clinical proof of concept in this complex disease.

As we discussed on our call in March we are focusing the goals for this trial towards establishing biological and clinical proof of concept in this complex disease.

Our Phase II trial leverages the broad range of organs and tissues involved in SSC pathophysiology to provide additional details on the therapeutic activity of CM101.

Our phase two trial Leverages, the broad range of Oregon's in tissues involved in S. C pathophysiology to provide additional detail on the therapeutic activity of T. M. One O one.

We expect the revised trial design to enable an expedited path to proof of concept data in SSC and, importantly, to provide additional information on CM101's activity in modifying the skin, lung, and vascular pathophysiology seen in SSC patients.

We expect the revised trial design to enable an expedited path to proof of concept data and that's S. C and importantly to provide additional information on sand water ones activity in modifying the skin lung and vascular pathophysiology seen in SSD.

Patients.

This study is being designed to enable us to make more informed decisions about specific patient stratification strategies, as well as to optimize the selection of endpoints for our subsequent trials in systemic sclerosis.

This study is being designed to enable us to make more informed decisions about specific patient stratification strategies as well as to optimize the selection of endpoints for our subsequent trials in systemic sclerosis.

We are currently actively engaged in designing this trial with the assistance of key opinion leaders in the field and are on track to launch the trial by the end of this year.

we will be providing further details on the PSD and SSD study designs this summer.

We will be providing further detail on the PSC and SSC study design this summer.

In summary, I'm pleased to report that we're making good progress towards obtaining.

In summary, I'm pleased to report that we're making good progress towards obtaining

data on dose-response relationships to inform the broader CM101 development program.

Ada on dose response relationship to inform the broader C am 101 development program.

proof of concept data on clinically relevant aspects of systemic sclerosis, a complex disorder with inflammatory vascular and fibrotic components.

Proof of concept data on clinically relevant aspect of systemic sclerosis, a complex disorder with inflammatory vascular and fibrotic components.

relevant safety and tolerability data to support the evaluation of higher doses of CM101, as well as to inform the next steps in the development of a subcutaneous formulation.

Relevant safety and Tolerability data to support the evaluation of higher doses of <unk> hundred one as well as to inform the next steps in the development of a subcutaneous formulation.

With that, I will turn the call over to Don Marvin, our Chief Financial Officer, Chief Operating Officer, and Executive Vice President. Don?

With that I will turn the call over to Don Marvin Our Chief Financial Officer, Chief Operating Officer, and Executive Vice President Don.

Good day. As CFO of HemaMab, I am pleased to have this opportunity to communicate directly with our shareholders and other stakeholders.

Good day.

CFO CMO Mab I am pleased to have this opportunity to communicate directly with our shareholders and other stakeholders.

Today, I will review highlights of our first quarter.

2022 financial performance. Please see the press release we issued this morning for more detail.

2022 financial performance. Please see the press release, we issued this morning for more detail.

The market for biotech stocks remains very challenging.

The market for biotech stock remains very challenging.

I want to reiterate that while we cannot change the market.

I want to reiterate that while we did not change the markets. We can ensure that we are not distracted from focusing on what we need to do to build a successful company.

we can ensure that we are not distracted from focusing on what we need to do to build a successful company.

And for ChemO-MAB, that is to ensure that we are pursuing the optimal development path for CM101.

For chemo Mab that is to ensure that we are pursuing the optimal development path or see them one on one.

prudently managing our finances, conserving capital to the extent feasible while advancing our clinical programs in as optimal fashion as possible, and monitoring our ecosystem for potential opportunities to bring additional attractive assets in-house and for tracking competitive challenges. We believe we are doing a good job delivering on these.

Prudently managing our finances, conserving capital to the extent feasible, while advancing our clinical programs and as optimal fashion as possible and monitoring our ecosystem for potential opportunities to bring additional attractive assets in house and for tracking competitive.

Challenges.

We believe we are doing a good job delivering on these and we will strive to do so going forward.

Let me now share a summary of our financial performance in the first quarter of 2022.

Cash, cash equivalents, and bank deposits were $57.5 million as of March 31, 2022, compared to $61.2 million at December 31, 2021.

Cash cash equivalents and bank deposits were $57 5 million as of March 31, 2022 compared to $61 2 million at December 31, 2021.

R&D expenses were $2.7 million for the quarter ended March 31, 2022, compared to $1.2 million for the same quarter in 2021. The increase in R&D expense year-over-year partly reflects the ramp-up in activities supporting our clinical programs for CM101.

R&D expenses were $2 7 million for the quarter ended March 31, 2022, compared to $1 2 million for the same quarter in 2021 the increase in R&D expense year over year, partly reflects the ramp up in activities supporting our clinical programs, we're seeing them.

One O one.

G&A expenses were $2 6 million for the quarter ended March 31, 2022, compared to <unk> 5 million for the same quarter in 2021.

G&A expenses were $2.6 million for the quarter ended March 31, 2022, compared to $0.5 million for the same quarter in 2021.

Please note that the 2022 figure includes a $900,000 non-cash stock-based compensation payment.

Please note that the 2022 figure includes a 900000 dollar noncash stock based compensation payment.

The increase in cash GNA in the first quarter partly reflects additions to the senior management team as well as upgrades to our Tel Aviv facilities.

The increase in cash G&A in the first quarter, partly reflects additions to the senior management team as well as upgrades to our Tel Aviv facilities.

Net loss was $5 1 million or a net loss of two cents per basic and diluted share for the first quarter of 2022.

Net loss was $5.1 million, or a net loss of $0.02 per basic and diluted share for the first quarter of 2022, compared to $1.7 million, or a net loss of $0.01 per basic and diluted share for the quarter ended March 31, 2021.

Compared to $1 7 million or a net loss of one cents per basic and diluted share for the quarter ended March 31, 2021.

The weighted average number of ordinary shares outstanding, basic and diluted were 228,090,300 which equals 11,404,515 ADSes and 156,751,771 which equals 7,837,589 ADSes.

Weighted average number of ordinary shares outstanding basic and diluted were 228.090 million 300.

Which equals 11.404 million 515, a D S says.

$156 million, 751771, which equals $7 million 837580, 980 S as well.

for the quarters ended March 31st, 2022 and March 31st, 2021, respectively.

For the quarters ended March 31, 2022 at March 31, 2021 respectively.

We continue to prudently manage our cash and currently expect our runway to last through the end of 'twenty 'twenty three as we indicated in our last call, which is six months longer than our previous guidance last year.

We continue to prudently manage our cash and currently expect our runway to last through the end of 2023, as we indicated in our last call, which is six months longer than our previous guidance last year.

Last month, we renewed our existing ATM facility with Cantor Fitzgerald with a current cap of about $18 million, a reduction from the $75 million cap in our original ATM facility.

Last month, we renewed our existing ATM facility with Cantor Fitzgerald with a current cap of about $18 million a reduction from the 75 million cap and our original ATM facility.

We consider this renewal to be a matter of prudent financial housekeeping and do not plan to draw on the facility at this time.

We appreciate your continued support and invite you to reach out if you would like to communicate with us directly I.

We appreciate your continued support and invite you to reach out if you would like to communicate with us directly. I will now turn the call back to Dale.

I will now turn the call back to Dale Dale.

We remain excited about the progress we've outlined today. I believe our team is doing an outstanding job of developing and implementing practical and achievable plans to strengthen our clinical programs and our company.

We remain excited about the progress we've outlined today I believe our team is doing an outstanding job of developing and implementing practical and achievable plan to strengthen our clinical programs and our company.

We see CM101 as a true pipeline and a product with its ability to act at the confluence of inflammation and fibrosis that is implicated in a variety of indications with high unmet need and strong commercial potential. We believe we are on the prudent and right path to building value in chemomab. We look forward to sharing more details with you in the next few months and appreciate your continued support. Operator, we're ready now to open.

We see C M. One O one as a true pipeline in a product with its ability to act at the confluence of inflammation and fibrosis that is implicated in a variety of indications with high unmet need and strong commercial potential. We believe we're on the prudent and right past the building value and chemo Mab.

We look forward to sharing more details with you in the next few months and appreciate your continued support.

Greater we're ready now to open the floor to questions.

Thank you at this time I will be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.

Thank you. At this time, I'll be conducting a question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question comes from the line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your question.

You May press star two if you'd like to remove your question from me Kim for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.

Our first question comes from the line of Kristen <unk> with Cantor Fitzgerald. Please proceed with your question.

Hi, good morning and good afternoon, everybody. Thanks for keeping my questions.

Hi, good morning, and good afternoon, everybody. Thanks for taking my questions. The first one I had was more of a big picture question first time of your program.

The first one I had was more of a big picture question for some of your programs.

given that these have traditionally been tougher hurdles for other companies in the past with their drugs. So to what degree in these indications do you believe that inflammation and fibrosis

These have traditionally been tougher hurdle for other companies in the past with their drugs. So to what degree and these indications do you believe that inflammation and fibrosis.

play a role together versus some of the failed approaches we've seen that really the mechanism is only able to impact or address one component and not the other. And then do you think that some of your early guided readouts are going to help provide more context around this point and thesis?

<unk> a barrel together versus some of the failed approaches we've seen that really the mechanism not only able to impact our dress one component and not the other and then do you think that some of your early guided readouts are going to help provide more context around the cleaning and thesis.

Thank you, Kristen. I think Adi Moore will be able to answer that question.

Thank you Kristen I think Oh D O more we'll be able to answer that question.

Yeah. Hi, Kristen. Thank you for the question. So, yes, you're right. Those are, those primary sclerosis and colangitis and systemic sclerosis are complex diseases that involve inflammation, fibrosis.

Hi, Kristen. Thank you for the question. So yes, you're right those are those paramus girls apologize in systemic sclerosis complex diseases involved inflammation fibrosis and even the either are processes that are involved and we believe based on the robust preclinical and initial clinical data that we already obtained over the year.

and even other processes that are involved. And we believe, based on the robust preclinical and initial clinical data that we already obtained over the years, that the unique MOA of CM101, enabling it to interfere with fibrosis by inhibiting fibrous activation with inflammation, by inhibiting type 2 immunity that is essential to support fibrosis, but also interfering with other pathologies that are very relevant for those diseases.

But the unique MLA with CMO under one enabling ethane to fear leads by Brexit by inhibiting Fabulous activation with inflammation by inhibiting type two immunity that is essential to support favorable but also interfering with other pathologies that are very relevant for that those diseases like.

Columbia sites proliferation for farmers to RASM cholangitis or the vascular angle in systemic sclerosis. So all of those combined differentiate <unk> from other drugs that were SaaS.

differentiating one-on-one from other drugs that were tested in

either of those indications and definitely pave the way for CM101 to be efficient in those indications.

Either of those indications and definitely paved the way for steam run around to be efficient in those indications.

As for your second question, so this is exactly why we are going to conduct these trials for systemic sclerosis, for example, the essence of this clinical trial will be to gain some initial proof of concept on the mechanism of CM1 in systemic sclerosis to allow us to design then the registrational study in a way that will increase significantly the chances for success you know with regards to CM101 and MOA specific

As for your second question. So this is exactly why we're going to from that these trials for systemic skirt. All this for example, the essence of this clinical trial will be today and some initial proof of concept on the mechanism. The same wanting to sense for others to allow us to design then the registration the Registrational study.

In a way that you have.

We increased significantly the chances for success and you know with regards to see him Leno won an MLA specifically.

Okay. I appreciate that thanks, and then can you help us frame some of the expectation for the PFC unless you read out I know, it's a largely to assess the safety, but do you expect the signals from these biomarkers that youre looking at are going to be able to speak to your point.

Okay, I appreciate that. Thanks. And then can you help us frame some of the expectations for the PSC in this readout? I know it's largely to assess the safety

But do you expect signals from these biomarkers that you're looking at are going to be able to speak to or point to the potential clinical efficacy at this dose and the follow-up period? And what exactly are you going to be looking for to help you really understand the different sample sizes for the other dose cohorts, both the lower and the higher?

The potential clinical efficacy.

And the follow up period, and what exactly are you going to be looking for to help you really understand the different sample sizes for the other dose cohort.

Higher.

Okay, I think Dave Wiener, our interim chief medical officer, would be able to answer that.

Okay, I think Oh, Dave Winter, our interim Chief Medical officer would be able to answer that.

Yeah happy to do so the purpose of the interim primarily is for us to gather the safety data that we've accrued on the 10 milligram per kilogram cohort. In addition to a safety data that is being derived from our liver fibrosis trial and that data will support advancement to the higher.

Yep, happy to do so. The purpose of the interim primarily is for us to gather the safety data that we've accrued on the 10 milligram per kilogram cohort, in addition to safety data that is being derived from our liver fibrosis trial. And that data will support advancement to the higher dose groups of 20 megs per Kig. So the primary purpose for the interim is to enable that dosing paradigm and cohort

Dose groups of 20 Megs per king so the the primary.

Purpose for the interim is to enable that dosing.

Paradigm in cohort going forward as you noted the second purpose there will be to look at the baseline variability on some of the key measures in the trial, including serum alkaline phosphatase and some in fibrosis and other related biomarkers to understand whether grew the group sizes that we have.

As you noted, the second purpose there will be to look at the baseline variability on some of the key measures in the trial, including serum alkaline phosphatase and some fibrosis and other related biomarkers to understand whether the group sizes that we are planning will be sufficient for us to detect the signal as the trial progresses and completes.

Our planning will be sufficient for us to detect a signal as the trial progresses and completes.

We will not be looking at measures of change from baseline in those markers. So at this interim analysis, we will not be reading out on any efficacy readouts from the limited number of patients that have been accrued to date in the 10 milligram per kilogram cohort, but we will be doing so in the near term as the trial progresses.

We will not be looking at measures of change from baseline in those markers. So at this interim analysis, we will not be reading out on any efficacy readouts from the limited number of patients that has been accrued to date in the 10 milligram per kilogram cohort, but we will be doing so in the near term as the trial.

Dresses.

Okay. Thank you and then last question for me just on the could you further elaborate on some of the other endpoint criteria, you're considering and speaking to you about kols at this time I know you know part of this is really just to kind of look at more of a holistic features.

Okay, thank you. And then last question for me just on SSC. Could you further elaborate on some of the other endpoint criteria you're considering and speaking to about KOLs at this time? I know, you know, part of this is really just to kind of look at more of the holistic features of the disease.

<unk>.

I think Dave you want to take that one.

Yeah happy to do that where we're in the midst of that process now we're refining the final outcomes that we intend to apply in the trial and that design as we noted before with some of the key experts in the field and we're going to provide a significant detail on that on our next call in August .

Yep, happy to do that. We're in the midst of that process now. We're refining the final outcomes that we intend to apply in the trial and that design, as we noted before, with some of the key experts in the field, and we're going to provide a significant detail on that on our next call in August .

Great. Thank you so much everybody.

Thank you.

Thank you. Our next question comes from the line of Jeff Jones with Oppenheimer. Please proceed with your question.

Thank you. Our next question comes from the line of Jeff Johnson with Oppenheimer. Please proceed with your question.

Good morning or afternoon, guys. Thanks for taking the question. A couple of questions in terms of the PSC trial. How many patients are you expecting to be in that safety readout?

Good morning, or afternoon, guys. Thanks for taking the question a couple of questions in terms of the PSC trial, how many patients are you expecting to be in that safety readout.

And.

The how.

The, how long will those patients have been treated when you get that readout?

How long will those patients have been treated.

When you use when you get that readout.

Dave I'll take that.

Yep. Well, we don't know yet because we have not created the date at which the data cutoff for that readout will be done. That will be determined in Q3 of this year to support the readout by the end of the year. So, we'll actually have a better idea as we get closer to that date to the exact number that will have been recruited into that cohort at that time.

Yeah, well, we don't know yet because we have not created the date at which the data cutoff for that readout will be done that that will be determined in Q3 of this year to support the readout by the end of the year. So we will actually have a better idea as we get closer to that date to the exact number that we'll have.

Been recruited into that cohort at that time.

All right. In terms of timing of the updates around PSC planning and SSC, you've mentioned sort of summer, you've mentioned August , so what is the plan around that and what format do you anticipate that taking?

Alright.

In terms of timing of the updates around PSC planning and the SSC.

You've mentioned sort of the summer you mentioned August so what is the plan around that and what format do you anticipate that take.

Dave you want to take that again.

Yeah.

Indeed, at our next quarterly call in August , we will relay significant details on the final amendment and revisions to the PSC trial and the core design for the SSC trial.

Indeed.

Our next quarterly call in August we will be it will relate significant details on the final amendment and revisions to the PSC trial and the core design for the excess C trial.

Great, Okay and then.

Great. Okay, and then last question. I know that you guys are going to be doing some BD work at the bio conference coming up. What's the focus of your BD activities?

Last question I know that you guys are going to be doing some BD work at the bio conference coming up what's.

What's the focus of your BD activities.

Okay, I think as Don Marvin you'll take that question yes.

Okay, I think Don Marvin will be able to take that question. Yeah, Jeff, it'll be a partnering. Obviously, we'll be talking to a number of potential interest in parties in CM101. We'll also be talking to other potential partners on assets that we have interest in. I think, as I mentioned earlier, we have a number of lines in the water and looking at possibility licensing or acquiring other assets to expand our pipeline. We'll be following up on those calls and those earlier discussions in San Diego in June .

Yeah, Jeff a it'll be a partnering obviously, we will be talking to a number of potential interested parties and see them. One on one will also be talking to other potential partners on assets that we have interest and I think as I've mentioned earlier, we have a number of lines in the water and looking at possibilities licensing or acquiring other assets to expand our.

Pipeline will be following up on those calls and those early discussions in San Diego in June .

Great.

Thank you.

There are more questions for me.

No more questions for me.

Thank you.

Thank you. Our next question comes from the line of Nathan Weinstein with Aegis capital. Please proceed with your question.

Thank you. Our next question comes from the line of Nathan Weinstein with Aegis Capital. Please proceed with your question.

Hey, good morning, Dale and the chemo and that team. So thanks for taking my questions.

Okay, good morning, Dale and the chemo-man team, so thanks for taking my questions. I guess just to start with on the sub-Q potential dosing route, can you opine on the importance of that route with the dosing convenience just in light of the fact that there's really nothing out there for these patients in PSC and SSC?

I guess just to start with on the sub Q potential dosing route can you opine on the importance of that route with the dosing convenience just in light of the fact that there's really nothing out there for these patients and P. S. T N F S C.

David would you like to take that.

Yep, happy to do so. I think, thanks for the question, Nathan. You are correct. You know, if CM 101 is able to have a significant impact on either of those disease states, the IV route of administration will not be a barrier to patient access and to treatment, given, as you just mentioned, the paucity of truly effective treatments in either one of those diseases.

Yeah happy to do so I think thanks for that.

Nathan you're correct.

<unk> see them one O. One is able to have a significant impact on either of those disease states.

IV route of administration will not be a barrier to patient access and to treatment given as you as you just mentioned the paucity of truly effective treatments in either one of those illnesses I think over time by the development of the sub Q formulation will add additional patient convenience and those indications.

I think over time, by the development of the sub-Q formulation, we'll add additional patient convenience in those indications. But importantly, we think it's quite critical for us, since we have a viable subcutaneous formulation, to continue to develop that to support any indication we may end up in, even though we may go beyond PSP or SPP.

But importantly, we think it is quite critical for us since we have a viable subcutaneous formulation to continue to develop that to support any indication. We may end up in even though we may go beyond the P. S. T. R. S. S C.

Okay, fair enough. Thank you. And maybe just one follow-up for me. On Total OPEX, it looks like it's been very well managed. And you guys have discussed the extended cash runway versus prior guidance, taking you, I think, to the end of 2023. Maybe just a housekeeping question in terms of some detail. How could those line items trend this year? Should we expect some sequential growth in OPEX throughout the year?

Okay Fair enough. Thank you and maybe just one follow up for me on on total Opex. It looks like it's been very well managed and you guys have discussed the extended cash runway versus prior guidance are taking you I think you said to the end of 2020 three maybe just a housekeeping.

Keeping question in terms of some detail how could those line items trend this year or should we expect some sequential growth in opex throughout the year.

Okay, Don Martin I'll take that yeah.

Okay, Don Marvin will take that. Yeah, OPEX is going to begin trending up over the balance of the year as we expand our PSC trial in the US and certainly in Spain as we indicated earlier and we begin to kick off the SSC trial in the fourth quarter of this year. So you'll see those OPEX expenses begin to trend up over the balance of the year.

Opex is going to begin trending up over the balance of the year as we expand our PSC trial.

In the U S and certainly in Spain, as we indicated earlier and we begin to kick off the SFC trial in the fourth quarter of this year. So you'll see those opex expenses begin to trend up over the balance of the year.

Okay, that makes sense. So thanks again for taking my questions and we're definitely excited to see how the rest of the year pans out for you guys.

Okay that makes sense. So thanks again for taking my questions and we're definitely excited to see how the rest of the year pans out for you guys.

Thank you.

Thank you, ladies and gentlemen that concludes our question and answer session I'll turn the floor back to Mr. Brooks for any final comments.

Thank you. Ladies and gentlemen, that concludes our question and answer session. I'll turn the floor back to Mr. Pokes for any final comments.

Yeah.

Thank you. This concludes our update on QMAP for Q1 2022 and we look forward to updating you at our next call. Thank you.

Thank you. This concludes our update on <unk> for Q1, 2022, and we look forward to updating you at our next call. Thank you.

Thank you. This concludes today's conference call you may disconnect. Your lines at this time. Thank you for your participation.

Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.

Q1 2022 Chemomab Therapeutics Ltd Earnings Call

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