Q3 2022 Chemomab Therapeutics Ltd Earnings Call
Greetings and welcome to Chemo map third quarter 2022 earnings conference call. At this time all participants all participants are in a listen only mode. A brief 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 key.
Pat.
As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host Linda Vice President of strategic Communications. Thank you you may begin.
Welcome to the chemo math Therapeutics 2022 third quarter conference call. Thank you for attending I am Barbara Lean time consulting Vice President of strategic communications at Cana that we can meet today, our Gal post our chairman and CEO, Don Marvin CFO Chief operator.
Officer, and executive Vice President Doctor I do more our co founder and Chief Scientific Officer and Dr. David with interim CMO 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 will expect intend plan and other similar words and expressions. All forward looking statements made today are based on management's current expectations.
Our 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.
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 implied.
Forward looking statements you can read 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 in the other unfortunate materials, we filed with the SEC.
Except as required by federal Securities laws Human <unk> 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 to Dale.
Welcome to the conference call covering the third quarter of 2022 I'm pleased to report that we have continued to make good progress on multiple fronts since our last call.
Today I will cover the following three advances we achieved during the third quarter first we advanced our clinical programs for <unk> hundred one our first in class molecule antibody that neutralizes CCL 24, a novel disease target at the confluence of fibrosis and inflammation.
Second we unveil promising clinical data from an investigator initiated lung injury study showing that see I'm wondering one reduce the biomarkers of lung inflammation and fiber Genesis in hospitalized COVID-19 patients with severe pneumonia.
Third we presented new preclinical data at two major scientific meetings.
Supporting the role of <unk> 24 in the pathophysiology of primary sclerosing cholangitis and second showing how chemo map has used biomarkers as a strategic tool to inform and Derisk our drug development programs.
We continued to make good progress in our <unk> 101 clinical programs as Dr. David Wiener will discuss in greater detail.
Summary, we have been working to ensure that our phase two liver fibrosis biomarker data will be analyzed and reported in the coming weeks. We continue to open new clinical sites for our phase III trial in primary sclerosing, cholangitis or PSC, while expanding our patient recruitment and outreach efforts and submitting the global regulatory.
Tori filings required to support trial expansion.
Lastly, we have designed our planned phase II trial in systemic sclerosis or SSC.
<unk> initiated study start up activities.
In support of our ongoing efforts to educate the scientific and medical communities about the critical role of <unk> 24 in fibro inflammatory diseases. The company made a number of presentations at important scientific meetings.
Most significantly with Dr. <unk> presentation of data from an investigator initiated clinical study of CMO no. One in hospitalized COVID-19 patients with serious lung involvement.
Andy will discuss these planning shortly we were very pleased to see that <unk> 101 was well tolerated and demonstrated activity on key biomarkers of inflammation and fiber Genesis that are also relevant for systemic sclerosis.
These seeing am 101 induced changes in biomarkers that have relevance across other fibrotic and inflammatory indications are a good example of the types of data we hope to see in the liver fibrosis biomarker study, we won't be reporting on later this year.
At the important American Association for the study of liver diseases a S. L. D meeting, we presented a poster with data that reinforces the key role of CCL 24 in the pathophysiology of PSC.
Human bed researchers used two animal models testing immune cell trafficking to show that CCL 24 plays a critical role in the recruitment and migration of monocytes and neutral bills major players in causing the biliary damage it characterizes PSC.
We also showed that <unk> 101 can interfere with CCL 24 stimulated migration of immune cells and an experiment animal model P. S C.
This new study adds to the growing body of evidence validating our CCL 24 target and confirming the therapeutic potential for our CCL 24 neutralizing antibody.
And yesterday, Dr. Moore was a featured speaker at the anti Fibrotic drug development summit in Boston, where she gave a presentation highlighting the growing use of inflammatory and fibrotic biomarkers to inform clinical trial design and Derisk drug development.
<unk>, how chemo map has strategically used biomarkers throughout the drug discovery and development process as a key translational tool and how we are continuing to use them today.
Let me now turn the call over to a D Moore, our co founder and CSO.
Thank you Bill today, I want to share new positive clinical data from our clinical study assessing San Juana line activity and safety in hospitalized patients with severe lung injury derived from COVID-19.
Earlier this week I presented this study and the Union Conference an international conference on lung health.
We also issued a press release on the study and the slides from the presentation will be available on the Q on my website.
So all of the mechanisms underlying lung inflammation, resulting from COVID-19 infection are similar to those seen in chronic diseases involving lung inflammation and fibrosis.
This study was initiated by Professor Hey, your Levy of Merit Medical Center in Israel, a rheumatologist, who treats patients with systemic sclerosis, and other room with a logical interviews.
The objective of the study was to evaluate the drug safety and activity in hospitalized COVID-19 patients with severe pneumonia, including its impact on biomarkers related to lung inflammation that are also relevant in systemic sclerosis.
The open label single arm trial, and they're all fixed in COVID-19 patients with severe respiratory involvement.
All patients were hospitalized anywhere a soothing styles of care therapy, including antiviral agent corticosteroids and supplemental oxygen.
Although were treated with a single 10 milligram per kilogram and prevent those are seeing why no. One on the first day of the study and followed for 30 days.
Clinical parameters worth us daily during hospitalization and serum biomarkers or tested at the baseline and on days 137, and 30 following drug administration.
Administration of see them one of them onto this acutely ill patient population was found to be safe and well tolerated.
101 exposures and target engagement profiles, where similar to let the team of researchers have seen in previous clinical studies with <unk> hundred one.
Importantly, rapid reductions in serum biomarkers of lung inflammation, Fibrogenesis and no default activity were observed post treatment with <unk> alone.
Reductions in serum levels of Biomarkers included the cytokine and fix your mine in <unk> field than two biomarkers that are highly associated with lung inflammation and are known to be strongly correlated with the respiratory severity for.
For example, fix Hilton was reduced by a median change of 65% from baseline as soon as 24 hour post strictness, let's see them one on one and further reduced by almost 80% of day three.
The effects were sustained through the end of the follow up period.
It was noteworthy too that the patients for saving CMO onto one demonstrated a rapid and robust median reduction of 50% and C reactive protein or CRP.
No in general marker of inflammation as soon as 48 hours plus of administration.
CRP levels were further decreased by more than 90% of basics after seeing one O. One administration and remain stable until the end of the follow up period.
See I'm wondering also demonstrated larger and more rapid CRP reductions compared to retrospective COVID-19 control group or had similar clinical characteristics and also received standard of care therapy.
Lastly, treatments with San Juan one impacted biomarkers that are associated with the formation of degradation of the extracellular matrix such as truckload that far and see three of them, which are highly elevated in these patients at baseline and were significantly reduced by a median change of 25% as soon as 72 hours post.
Treatment of reduction that remains stable until the end of the follow up period.
In conclusion. This study confirmed and extended the safety and Tolerability profile of <unk> see them, one on one and demonstrated a clinically relevant changes in biomarker associated with lung inflammation and Firebird Genesis further supporting San Juana ones aren't inflammatory and anti fibrotic effects.
Moreover, we believe that these results add to the data, suggesting the Tijuana one has the potential to attenuate as lung inflammation and fibrosis further strengthening the rationale for treating systemic through all these patients with this drug.
These new clinical data also contribute to a growing body of evidence demonstrating C and one on ones anti fibrotic and anti inflammatory effects in various organs, including the lung liver and skin.
We look forward to supplementing these encouraging data with the clinical and biomarker data, we will be reporting in the coming weeks for a lever fibrosis study in Nash patients.
Together, we expect them to increase our understanding of the potential throughput I think you'd see what you see in one to one across a number of fiber and inflammatory disorders.
I will now turn the call over to Dr. Dave Rayner, our interim Chief Medical Officer.
Good morning today, I will be providing brief updates on the status of our cm. One O one liver fibrosis trial in Nash patients and our phase two trial in primary sclerosing cholangitis I.
I will focus my remarks on providing an overview of the design of our phase two trial of <unk> hundred one in patients with systemic sclerosis, we've been working closely with experts and look forward to sharing the planned study with you in the systemic sclerosis community.
Let me begin with the liver fibrosis trial, a randomized placebo controlled trial evaluating <unk> hundred one administered subcutaneously at a dose of five milligrams per kilogram in patients with nonalcoholic <unk> hepatitis or Nash.
We are on target for our final trial readout before year end and look forward to sharing the clinical data at that time.
We believe that the data from this trial will provide useful insights in support of the overall 101 development program.
Although the sample size is small the encouraging signs of activity. We saw in the phase <unk> study of <unk> 101 in Nashville to patients and the biomarker activity reported this week and a lung injury study in hospitalized COVID-19 patients.
Makes us optimistic that this study will produce informative results.
Importantly, these data represent the first readout of C am 100 ones activity in patients with established liver disease.
As I've noted previously we believe the study results should also provide us the pharmacokinetic and tolerability data needed to inform the next steps in the development of our current subcutaneous formulation of <unk> hundred one.
Turning to our phase two primary sclerosing cholangitis trial.
We continue to actively recruit patients across clinical trials sites in the U S Europe and Israel.
We're adding additional trial sites and are advancing the regulatory submissions needed for implementation of a major protocol Amendment supporting trial expansion and open label dosing.
We are ramping up recruitment activities via personal outreach to clinical investigators and staff.
Forming collaborations with patient advocacy groups, enhancing our patient and physician communications and.
And increasing our use of social media and other proven method of reaching patients and referring physicians.
We believe these efforts will enable us to meet our recruitment goals.
We currently remain on track to report out top line data from the double blind portion of the trial in the second half of 'twenty 'twenty four.
Lastly, we will be performing an interim safety analysis of the currently enrolling dose cohort and expect the analysis to be completed before the end of this year.
The primary purpose of this safety analysis is to enable review by the Cm One O one data monitoring committee.
To support the evaluation of the higher 20 milligram per kilogram dose in the sea am 101 clinical development program.
Turning to systemic sclerosis.
We are providing an overview of our planned clinical trial in systemic sclerosis or F. F C.
FSC is a complex room at a logic disorder characterized by inflammatory and fibrotic pathophysiology in multiple tissues.
<unk> recent approvals of therapies that can slow the progression of interstitial lung disease and FSC patients there remains a clear unmet medical need in this disorder.
Our novel Therapeutics that address various manifestations of the disease.
Particularly the dermatologic aspects would represent a major advance in the treatment of FSC.
We are initiating our clinical evaluations based on a strong therapeutic rationale for the neutralization of CCL 24 in this rare disease.
This rationale includes multiple convergent lines of evidence including.
Demonstration of CCL twenty-four expression and relevant physiology in the skin vasculature and lung.
Demonstration that genetic deletion of CCL 24 in rodents attenuates medical stations of skin and lung disease and of Bleomycin challenge model of FSC.
And translational data, suggesting that patients with SSE have high serum levels of CTO 24, and that higher levels of PCL 'twenty four and these patients are correlated with a greater likelihood of developing pulmonary disease.
In this trial and SFC patients, we seek to confirm the critical role of <unk> 24 in this disease.
And to generate data that can establish biological and clinical proof of concept, where Sam water one.
This study is designed to enable us to identify the optimal patient population within the SFC to target with the am 101 as.
As well as inform the selection of appropriate endpoints for subsequent trials.
To that end, we will enrich the study with epilepsy patients who have higher levels of PCL 24, and may therefore be more likely to respond to neutralization of this critical came a carton.
We will also study patients with limited and those with diffused cutaneous manifestations of the disease.
The trial will be a randomized double blinded placebo controlled study that will enroll 60 patients with FSC.
To be eligible for the study patients must manifest two key characteristics.
The presence of clinically active disease.
Is there a dermatologic or pulmonary and high serum levels of circulating CPL 24.
40 patients will be randomized to treatment with see them one on one and 20 patients will be randomized to placebo.
Of the 40 patients on active treatment approximately half will have limited efficacy and half will have diffuse cutaneous disease.
This study includes a 24 week double blind period during which patients assigned to active treatment will receive C. Am 101 at a dose of 10 milligrams per kilogram via intravenous infusion every three weeks.
Following the double blind period patients will enter a 24 week open label treatment period, where all patients will receive C. Am 101 at a dose of 20 milligrams per kilogram via intravenous infusion every three weeks.
All patients enrolled will undergo a skin biopsy at baseline and again after the double blind treatment period, along with multiple clinical assessments of skin vascular and pulmonary function.
The primary outcome measure for the trial will be demonstration of the safety and tolerability of treatment with <unk> hundred one.
All other outcome measures will be principally assessed as changes from baseline to the end of the double blind treatment period.
The secondary outcome measures of the trial are focused on highly relevant and informative biological readouts.
Secondary outcomes include.
Evaluation of multiple serum based biological markers that are known to be associated with different manifestations of FSC, including.
Inflammatory cytokines, such as C. C O two IL six and C C O pen.
So vascular and growth factor related biomarkers, such as bed draft and PDGF.
Pulmonary related biomarkers, such as K O S.
S P D and CCL 18.
And lastly, fiber Genesis and extra cellular matrix biomarkers, such as collagen and then Pes and E. L F scores.
Inflammatory fibrotic and target expression markers in skin biopsies, including but not limited to <unk> 24, and CCR three expression levels.
Pharmacokinetics and target engagement of C am 101.
And we will monitor for the presence of any potential anti drug antibodies during the study.
Exploratory biological outcome assessments will include immune cell phenotyping.
Assessments of neutrophil function and ex vivo biological assay.
Exploratory clinical outcomes will include evaluations of <unk>.
<unk> involvement using nail full capital Uroscopy vascular imaging and digital ulcer burden.
Skin involvement using the modified rodman, scoring.
Pulmonary disease involvement using pulmonary function tests.
And multiple patient reported outcome measures.
The data collected should also enable us to evaluate global effect on intervention with am 101, using the revised Chris Yeah.
We intend to conduct this study at multiple sites in the United States.
European Union and Israel.
We are currently finalizing the required regulatory documents and we intend to file an investigational new drug application with the U S food and drug administration in the coming weeks.
We anticipate that the trial will be open for enrollment by the end of this year or early in Q1 of 2023.
And we anticipate that the top line data readouts for the trial will be available in the second half of 'twenty 'twenty four.
With that I will turn the call over to Don Marvin Our Chief Financial Officer, Chief Operating Officer, and Executive Vice President.
Yeah.
Good day.
So Kim I Mab I am pleased to have this opportunity to communicate directly with our shareholders and other stakeholders.
Today, I will review highlights of our third quarter 2022 financial performance.
Please see the press release, we issued this morning for more detail.
As you know the market for biotech stocks remains very challenging.
I want to note again that while we cannot change the markets. We can ensure that we are not distracted from focusing on what we need to do to build a successful company.
And for Chemo bad that is to ensure we are pursuing the optimal development path towards see them one on one.
Prudently managing our finances.
Serving capital to the extent feasible, while advancing our clinical programs and as rigorous a fashion as possible.
And monitoring our ecosystem for potential opportunities to bring additional attractive assets.
House as resources permit.
And for tracking and competitive challenges.
We believe we are doing a good job delivering on these goals.
We will strive to do so going forward.
Let me now share a summary of our financial performance for the third quarter of 2022.
Cash cash equivalents and bank deposits were $46 5 million.
As of September 30th 2022.
Paired to $51.8 million.
June 30th 2022.
R&D expenses were $5 4 million for the quarter ended September 32022.
Paired to $1 5 million for the same quarter in 2021.
The increase in R&D expense year over year, primarily reflects the increase in activities in support of our preclinical and clinical programs.
G&A expenses were $2 9 million for the quarter.
At September 32022.
Compared to $1 4 million for the same quarter in 2021.
The increase was primarily due to increases in salaries and related benefits expenses, mainly related to key additions to the senior management team.
As well as increases in noncash share based expenses.
Net loss was $8 1 million or a net loss of approximately three and a half cents per basic and diluted ordinary share for the third quarter of 2022.
Impaired to $3 million or a net loss of approximately one.
One of the third cents per basic and diluted ordinary share for the quarter ended September 30th 2021.
Weighted average number of ordinary shares outstanding basic and diluted were $228 million 773418 equal to approximately $11 4 million.
Dsos for the quarter ended September 30th 2000.
'twenty two.
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.
We appreciate your continuing 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.
Dale.
I hope we have conveyed some of our excitement about the momentum we are building a chemo mill, we look forward to sharing the results of our liver fibrosis biomarker trial in the coming weeks to continuing to expand and accelerate our PSC trial and to launching our innovative systemic sclerosis trial.
These debilitating diseases are currently so poorly treated.
We are optimistic that the unique dual mechanism of <unk> hundred one has the potential to modify the progression of these disorders at the confluence of inflammation and fibrosis.
To make a real difference for patients.
We do appreciate your continued support stay tuned.
Operator, we are ready to open the floor to questions.
Thank you we will now be conducting a question and answer session. If he would 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.
You May press star two if he would like to remove your question from the queue.
Participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
One moment, please while we poll for questions.
Our first question is from Christian <unk> with Cantor Fitzgerald. Please proceed with your question.
Hi, good morning, and good afternoon, everybody. Thanks for taking my questions first on FSC could you talk about the percent of the overall patient population that has these higher levels of CCL 24, and that you're hoping to enroll and then I know not preclinical you've shown a.
<unk> 24, a levels and disease severity. So should we be expecting these patients to be more on the moderate to severe disease spectrum.
David you want to start with that and then maybe I'll pass it to Andy.
Yeah happy to do that good morning system, Yes, we are actually mapping out currently what CCL 24 levels look like across the systemic sclerosis population the intent and the trial is to not impair enrollment the will enroll those with probably with a roughly about 70% to 75%.
Tile or greater.
Levels within systemic sclerosis, as we screen and so without a deep knowledge and deep understanding of what exact cutoffs are for this particular experimental cytokine in that population, we're approaching it from a very practical perspective, where we intend to.
Essentially exclude those with very low levels.
Sure.
Yeah. Thank you so I just going to add to your second question of Christian and thank you for that.
Is that indeed, we have seen in the past that the sales went too far correlate with several of the measure of randomness manifestations of systemic sclerosis.
Now you did your title or basketball IRA related one as well as some fibrotic related biomarkers like al. So we just see that or believed that this population with the cost of average will be determined and will provide a better chance for success are in terms of.
And you're rolling the more relevant fashion twist yourself went too far and the one that are more active overall in that different spaces.
Thank you for that and are you aware of any obvious items that might correlate with higher levels of CCL 24 without necessarily conducting some of these extensive tests. So I know it has a role in both the fibrotic and inflammatory markers of these condition.
But for example, like are there certain symptomology that are more reflective of having CCL 24 levels or perhaps have you noted any differences related to different patient from coming from different geographies.
Do you want to take that one yeah sure. So that's about the geographies, but we did see definitely correlations between Seychelles went before and now we have seen that patients with higher socio plentiful at baseline of half or more predictive for the penetration of their lung function and we're also seeing a day.
Correlations with them or basketball or did you sell all sort of related that manifestation of the disease. So this is overall, what we've seen so far and part of why we have decided to include this parameter.
Criteria.
Okay. Thanks, and maybe last question for me you've had a number of scientific presentations over the last couple of days here, we'd love to hear some of the feedback you've heard from the scientific community.
Yeah sure so actually at the graduate forgot at the Sheraton, just yesterday, I presented and in Boston and the asset with a great audience of physicians and researchers are specifically in the sale of a fat inflammation and fibrosis and I also presented that the study that was presented at the Union conference that.
A day earlier.
Well, we've seen clearly that the administration of San Juan and one single dose of <unk>, one O one into patients with lung injury derived Joseph COVID-19, and obviously well all know all know the similarity in the lung injury between club at 19, and some other chronic diseases like sustaining projects.
Okay.
Okay.
Our next question comes from Jeff Jones with Oppenheimer. Please proceed with your question.
Good morning, or good afternoon, guys, depending on where you're sitting and thanks for taking the question.
I guess.
Two questions one I guess just following on the biomarker.
Discussion is there a way that you've looked at to evaluate if the CCL twenty-four elevation as a result of the inflammatory state or if it's a driver.
Using related Biomarkers.
As to differentiate those patient populations more discriminate Lee as to who are likely to be responders to therapy.
And then on the PSC side.
I believe you indicated topline data from the blind courts population or the.
The portion of the study in two weeks 24.
Have you given any thought to reporting out interim data, perhaps on the original 10 Meg per kg cohort.
Thanks.
Dave you want to pick up the second one first.
Sure happy to do that so morning, exactly true, yes that is certainly a consideration we may we have that as an option that we can include particularly since that cohort is likely as you surmise to enroll in the nearer term than the full Covid then all the additional cohorts that we added through the <unk>.
Amendment and trial expansion as we position this study and think about this study.
It is our hope in the longer run that this could be a regulatory only supportive study and as such we would like to protected in that sense and so that decision. Although its an option to us those are the two things that will Wang an earlier look at data versus the quote unquote hate you take when you're doing it.
Interim analysis on study power for any particular outcome.
I think more more more to here there is as our travel unfolds.
Also.
Yes.
Yes, I'm happy to start on the second question then if I do the returns on the timeframe of Harris is you can hear me.
Okay, Great wonderful on the CCL 24, the strategy here is to <unk>.
To enrich biologically and this early trial for patients that have high levels of our target right and this is a mechanism to do that quite straightforwardly. The questions that you've asked the very are exactly the ones. We're exploring right. So <unk> and her colleagues and many people have been exploring and looking at.
Neither through retrospectively or looking at.
Different patient populations and trying to ask the question of what is the relevance of those elevated levels with respect to how do they correlate either to biomarkers or to clinical outcomes and clearly we see very encouraging data. There. This is the motivation for us to study exactly that population with our antibody that neutralize.
The CCL 24, so I think the actual trial itself is going to ask the question, you're asking which is in that group of patients does is what is the relationship between those higher levels and biomarkers with clinical outcomes, we'll get insight in that from the trial and will also understand whether neutralizing that.
But would have a greater effect size given the higher levels to begin with so that's part of the strategy there Audi.
Yeah, I think you covered that are very well you were asking Jeff is it's kind of a the cause or are part of the cycle and you know for systemic sclerosis, and PC, where obviously I'm not familiar with with what is the cause of disease, but we have seen pre clinically.
T cells 94, he's involved in kind of perpetuating this vicious cycle of inflammation and fibrosis. So even if the injury or some kind of an environmental or genetic trying to fat arisen. Since he has went to four was found by our models to kind of further progression of disease in this vicious cycle by its expression alone.
Great.
I appreciate that insight.
Yes.
Thank you.
As a reminder, if you'd like to ask a question. Please press star one on your telephone keypad.
Yeah.
Okay. It appears that there are no further questions at this time, so I would now like to turn the floor back over to management for closing comments.
Well. Thank you for your questions and interest in keeping them up today I believe our team and programs are making great progress and we look forward to further updates in the months ahead. Thank you very much.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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