Q4 2021 Chemomab Therapeutics Ltd Earnings Call
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Greetings and welcome.
<unk> fourth quarter, and full year, 2020 one 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. Please note. This conference is being recorded.
I will turn the conference over to Barbara Linda <unk>, Vice President of Investor Relations.
Welcome.
Welcome to the <unk> Therapeutics, 2021 fourth quarter and full year results conference call.
Thank you for attending I am Barbara Lean time consulting Vice President of Communications are keen on that with me today are Dale coast, our chairman and CEO , Don logging CFO , Chief operating officer, and Executive Vice President Dr. David winner Shimon that interim chief medical.
So sure Dr. Jim Moore, our co founder and Chief Scientific Officer.
Before I turn the call over to Gail. So you should 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. All forward looking statements made today are based on management's current expectations. Some.
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 before.
Looking statements you can read a comprehensive list of those factors under the heading risk factors.
Thank you and our annual report on Form 10-K , together with factors under similar heading and the other reports and materials, we filed with the SEC, except as required by federal security laws Human <unk> does not undertake to publicly update or revise any forward looking statements subsequent to the date.
<unk> made as a result of new information future events changing circumstances or for any other reason.
We now turn the call over to jail Dale.
Welcome to the first quarterly conference call covering 2021 fourth quarter and full year, along with an update on our planned activities for 2022.
I came on board as CEO . This past September after a careful review of the company's science.
He was impressed by the clinical and commercial potential of C. Am 101, our pipeline in the product focusing on indications that the confluence of inflammation fibrogenesis area of great unmet medical need.
Also by the rigorous translational and preclinical science produced by our co founder and CSO, Dr. A deep more entertainment.
Our lead clinical candidate <unk> hundred one is a monoclonal antibody that neutralizes CCL 24, a unique target that has been validated and 11 preclinical model systems.
<unk> has demonstrated good safety and pharmacokinetics and pharmacodynamics and two phase one studies in both healthy volunteers and patients, which further supports our belief that see them. One one is first in class potential cause of two rare disease indications of primary sclerosing cholangitis or PSC and so.
Stomach cirrhosis SSE.
As well as an additional clinical indications.
But it became a M CEO and now also chairman I believe the company has a very bright future and I look forward to sharing that progress with you.
First an overview of our progress in 2021 which was an eventful year for came about.
Accomplishments included.
In February we announced positive results from a phase one b trial in patients with non alcoholic fatty liver disease reporting that <unk> see them. One on one was observed to be safe and well tolerated upon multiple administrations.
With evidence for dose dependent target engagement and positive changes in fibrotic biomarkers in.
In March he remember had completed a merger transaction listed as a D ours on NASDAQ and closed a $45 $5 million of pipe.
As part of the merger and public listing human Mab expanded its board of directors, adding industry savvy directors with business and clinical development expertise in <unk>.
April we dosed the first patient in our C am 101 phase two liver fibrosis biomarker and subcutaneous formulation study in.
In June the company expanded its partnership with AGC Biologics for final optimization and production of GMP manufacturing batches of C. Am 101, a partnership that continues to go well.
In September we announced a collaboration with researchers at Leeds University to further elucidate the role of C. Am 100 ones target CCL 24 in the vascular damage associated with systemic sclerosis.
In November Dawn, Marvin joined as Chief Financial Officer, Executive Vice President and Chief Operating Officer, Don and I have worked together in the past and I can attest to the tremendous strategic and operating expertise he brings to <unk>.
In December we received approval from the FDA for our first U S. I N D aimed at expanding clinical activities in our PSC phase II trial.
We were also fortunate to have had doctor David Winter joined US as interim CMO in December David is an accomplished biotech senior executive who was exceedingly well burst in the design implementation and interpretation of large and small molecule clinical development programs.
And at the start of the new year. He was joined by Jack Lawler, Our VP of global clinical development operations, who also brings us a wealth of practical clinical development execution experience.
We've recently undertaken a review of our C am 101 clinical programs, bringing fresh perspectives to an assessment of the company's strategic aims and how best to achieve them.
This review was based on several important developments, including the on boarding of our expanded senior management team.
Recent feedback from key global regulatory authorities.
<unk> continuing impact on clinical trial recruitment and development timelines and the challenging financial markets for newly public small cap biotechnology companies.
Our aim is to optimize the clinical development of C. F 101 by decreasing overall risk.
Clinical program.
Maximizing the clinical information obtained to facilitate decision making.
Generating critical data to support advancement to Registrational trials and optimizing the overall clinical development plan for <unk> hundred one in systemic sclerosis N P. S C as well as potentially an additional indications where the scientific rationale and strong in short we want to achieve biological and pharmacological validation for <unk>.
101 sooner and prepare to advance two registrational trials quickly and efficiently.
I'm going to come back to these aims in a few minutes. The reviewers who included our research and clinical teams and our clinical eat knowledgeable human lab directors have recommended important modifications to the current clinical programs for see them one on one.
We believe this is good news and we're excited to share with you today.
I'll first give a brief overview and then Dave will expand on a few major points.
There are three Keystone improvements one.
Expanding our commitment to PSC within a large clinical trial that adds an important dose finding component.
To.
Focusing on our systemic sclerosis clinical efforts on establishing earlier biological and clinical proof of concept for see them. One on one in this indication free.
Free.
Winding down enrollment in our safety PK and biomarker liver fibrosis study with final clinical Readouts expected near the end of this year.
One benefit of these revisions is.
They will provide more clinical data readouts over the next 24 months, we anticipate three to four clinical readouts compared to the two previously planned and importantly, they are designed to achieve the aims I outline more rapidly generating informative data. They will help drive the next steps in clinical programs, while decreasing our cap.
Requirements, and we estimate extending our cash runway by about six months through the end of 2023.
We intend to provide significantly more detail about the revised clinical program in the next few months likely around the first quarter 2022 earnings call in May.
I will now turn the call over to Dr. David winner, who will provide more background on the clinical rationale for the changes.
Dale.
As Dale noted the strategic review has resulted in a number of important changes to the <unk> hundred one clinical development program.
We initiated this review based on multiple relevant factors, most notably upon receipt of key feedback from global regulatory authorities.
I am presenting the broad outlines of the revised plan, we expect to provide significantly more detail in several months time.
Key elements of the revised clinical program include.
Implementing a dose finding component to the sea am 101 development program by significantly expanding our phase two trial for primary sclerosing cholangitis.
We are currently exploring the safety Tolerability and importantly, the biomarker and clinical activity of 10 Megs per kilogram of sea am 101 administered intravenously every three weeks over 15 weeks.
We will be increasing the size of the study by adding additional dose cohorts, including plans to evaluate both a lower and a higher dose level of <unk> hundred one in this ongoing trial.
In addition, we plan to add an open label extension to the trial to evaluate the safety tolerability and durability of effect over longer treatment durations. Finally, we will be performing an interim analysis of the currently enrolling dose cohort in this study to assess safety and biomarker.
Marker data with an expected readout in the second half of this year.
Regarding systemic sclerosis focus the goals of our systemic sclerosis trial towards establishing biological and clinical proof of concept in this patient population.
We are revising the design of our planned systemic sclerosis trial in a way that should enable an expedited path to proof of concept data.
As well as further elucidation of the different mechanisms of action of <unk> hundred one in treating the skin lung and vascular damage seen in systemic sclerosis patients.
The data obtained from this study could potentially provide a clear and rapid clinical route forward by enabling more informed decisions about the selection of patients and primary endpoints for Registrational trials.
We are currently working with key systemic sclerosis research and clinical experts to refine and finalize the design and study endpoints of the phase II trial.
We anticipate that these activities will result in trial initiation in the second half of this year.
Lastly, as we ramp up our activities for our primary indications of primary sclerosing cholangitis in systemic sclerosis.
We'll be winding down our ongoing safety Tolerability and biomarker trial that is evaluating a five milligram per kilogram dose of the subcutaneous formulation of <unk> hundred one and liver fibrosis patients.
We will be halting screening and enrollment in the coming weeks and.
And based on the timing required for all enrolled patients to complete all study visits we anticipate the final clinical readout will be around the end of this year.
The data Readouts in this study will include safety and Tolerability data to support future development.
And deeper insight into C. M 100 one's mechanism of action, providing additional data on the anti inflammatory and anti fibrotic activity of C. M. One O one and liver diseases.
Finally, a key objective of this study is to explore the safety and drug exposures associated with our sub Q formulation.
We believe the early completion of the study should be sufficient to achieve this purpose.
<unk> the pharmacokinetic data needed to assess our next steps in the development of the subcutaneous formulation of <unk> hundred one.
The proposed changes to the development program for <unk> 101 are expected to provide the following key data.
To obtain important data on the clinical dose response relationships to inform the broader development program.
And if the data are supportive to identify the optimal dose to advance in later trials in primary sclerosing cholangitis.
To obtain proof of concept data on clinically relevant aspects of systemic sclerosis.
Complex rheumatologist disorder, with both inflammatory and fibrotic components.
To best inform the development path for a novel first in class therapeutic like <unk> 101.
And to obtain relevant safety and Tolerability data.
To support the evaluation of higher doses of <unk> 101.
As well as inform the next steps in the development of the subcutaneous formulation.
Overall these changes should also provide additional benefits, including sharpening our focus on our clinical efforts on the rare diseases of primary sclerosing cholangitis and systemic sclerosis.
Accelerate the timeline, particularly in systemic sclerosis to the achievement of meaningful mechanistic biological and clinical proof of concept data.
With that I will turn the call over to Don Marvin Our Chief Financial Officer, Chief Operating Officer, and Executive Vice President.
Sean.
Good day.
F O of chemo that I am pleased to have this opportunity.
Communicate directly with our shareholders and other stakeholders.
Today I will review highlights of our 2021 financial performance.
See the press release, we issued this morning for more detail.
I will also briefly discuss our thoughts about the company's financial outlook for 2020 two.
Our first ever quarterly conference call is taking place during a particularly challenging time in the biotech industry.
Like many of you I have been through tough market cycles, before and know how painful they could be however.
Also note that down cycles inevitably cycle to better times.
I believe this one will too.
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 keeping them bad management that is to ensure we are pursuing the optimal development plan for <unk> hundred one.
Prudently managing our finances.
<unk> the greatest ROI on our investments.
Conserving capital to the extent feasible, while advancing our clinical programs and as optimal fashion as possible and monitoring our ecosystem where potential opportunities to bring additional attractive assets in house.
Let me now share a summary.
Our financial performance in 2021.
In addition to the detail included in today's press release, we also expect to be filing our 10-K annual report before the end of March.
Cash and cash equivalents were $61 2 million as of December 31, 2021, compared to $11 8 million as of December 31, 2020.
R&D expenses were $2 4 million for the quarter.
$6 3 million for the full year ended December 31, 2021, compared to $1 3 million and $4 7 million.
For the same quarter and year in 2020.
G&A expenses were $2 6 million.
Quarter, and $6 1 million for the full year.
We ended December 31, 2021 compared to <unk> 7 million and $1 3 million for the same quarter and year end 2020.
Net loss was 5 million or a net loss of two cents per basic and diluted share for the fourth quarter and $12 5 million or a net loss of six cents per basic and diluted share for the year ended December 31st 2021, compared to $2 6 million.
Or a net loss of two cents per basic and diluted share for the quarter and $6 million or a net loss of four cents per basic and diluted share for the full year ended December 31st plenty plenty.
The weighted average number of ordinary shares outstanding basic and diluted of $207 million 468650, and $136 million 750498 for the year ended December 31.
2021, and December 31 2020, respectively.
As Dale and Dave described a cornerstone of our efforts over the coming months will be to implement revisions to our clinical program for Syn 101.
As noted we expect these changes may allow us to achieve clinical validation sooner.
Cost and with less risk, while providing us more data readouts, along the way and better positioning of C. M. One O one for subsequent Registrational trials.
Since its inception chemo map has been characterized by a sufficient use of capital and I'm pleased to report that we are upholding that tradition.
Sharing we are continuing to work smarter and more efficiently and every area of our operations.
And as we have noted.
The changes we are implementing to strengthen our clinical programs also have the beneficial effect of causing less than the original plans.
As a result of these expected savings and clinical spend and our plans for continued prudent management.
Corporate resources I am pleased to confirm that we now expect to have adequate capital to sustain the company through the end of 2023.
This is about six months longer than our prior forecast.
Not being required to raise new funds during market downturns is a good thing and it provides us greater flexibility.
Another important initiative for 2022 is enhancing and extending our corporate and Investor communications and outreach to better educate.
And inform our various stakeholders about the potential and progress of our clinical programs.
We are updating and refreshing, our corporate and investor materials and are planning an active round of investor conferences non deal Roadshows, social media outreach K O L events, and other special virtual and in person investor activities as appropriate.
We believe we have a compelling story to tell and we will work to ensure that it is more widely known and appreciated going forward.
Summary, we are excited about the therapeutic potential of C am 101, and the opportunities afforded by our revised clinical development program to achieve strong momentum at chemo bad over the rest of 2022 into 2023.
We believe we have the opportunity to make a significant difference.
Patients' lives, while continuing to build a vibrant and valuable company.
We appreciate your continued support.
Might you to reach out if you would like to communicate with us directly.
I will now turn the call back to Dale.
Bill.
We are excited about the revised clinical program, we outlined today I believe our team has done an outstanding job of developing practical and achievable plans to strengthen our clinical programs.
We'd see see am 101 has great potential as a 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 medical need and strong commercial potential.
We believe we're on the prudent and right path to building value it came about.
With our new plan over the next 24 months, we expect to.
Generate more informative milestones and catalysts b.
Be better positioned for a potential registrational trials and achieved this while preserving capital.
We look forward to sharing more details of our revised clinical programs with you in the next few months and thank you for your continued support.
Thank you Dale.
Concludes our prepared remarks, operator, we are ready for questions.
Thank you if he would like to ask a question. Please press star one on your telephone keypad.
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You May press Star two.
Remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing I'm sorry, Keith.
Please ask one question and one follow up question and then re queue for additional questions.
Our first question is from Kristen.
Scott with Cantor Fitzgerald. Please proceed.
Hi, good morning, and good afternoon, everybody. Thanks for taking my question there on systemic sclerosis, So I wanted to ask.
I understand some of the endpoint could differ based on you wanting to look at a more holistic package of effect on the different Oregon that play a role for these patients, but maybe could you further comment on some of the trial design implementations you're considering at this point. So for example are you looking at gene.
Across inclusion exclusion criteria to understand different levels of severity or looking at different doses.
Study as well as length of time or is it kind of all of the above at this point.
Yes, hi, it's it's kind of all of the business.
We are we have changed the goals of what we're trying to achieve and SFC and we're moving towards an exploratory and clinical proof of concept and we're going to do exactly that we believe <unk> hundred one has a unique opportunity in this very heterogeneous disease to address multiple components, so rather than initially.
Focusing on a composite endpoint, we intend to more deeply explore each of those individual components in a more in a revised trial design and we intend to provide more clarity on that design in the coming months.
Okay got it thanks for that and then my second and final question is just on the subcutaneous study.
Sounds like based off this decision that you think that there is at least enough definitive evidence for you to understand the effects with this type of formulation.
So can you just confirm that and then you know assuming that things readout positively you're happy with the result is the plan. After these initial PSTN SSE studies to then consider moving into a subcutaneous trial.
So yes, we are continuing to explore the non clinical aspects of the formulation and optimizing them and later this year when we get the readout from the liver fibrosis trial, which is the trial that is being conducted with the sub Q formulation that exposure and pharmacokinetic data, we will determine what our.
Next steps in the clinical program.
And indeed the goal here is to advance that such that it'll be either usable in our registration programs or soon thereafter.
Okay.
Got it thanks, so much for taking my question.
Thank you.
As a reminder, this star one on your telephone keypad, if he would like to ask a question. Our next question is from Nathan Weinstein with Aegis capital. Please proceed.
Thank you good morning, Dan and the team on that team. So thanks, so much for taking my questions and the first one is just on P. S. C. A regarding including a higher dose just what gives you the confidence to include a higher dose in the revised Ah trial.
I'm not exactly sure what mean by confidence, but we our desire here.
Is to explore more than the single dose that we're currently interrogating mix per gig. The rationale is to add a lower dose and a higher dose. We believe that the 20 the safety observed to date with C. M. One O one across all of the populations, which is quite good we will support us advancing too.
To the evaluation of the 20 Meg per kg.
Dosing in the PSC trial in the near future.
Okay. That's exactly what I was hoping to hear so I appreciate that and then secondly, with the extended cash runway I guess conceivably does that take us through at least the initiation of a perspective, a registration study in one or both of the indications.
As we've stated before we have sufficient cash to run the operations through the end of 'twenty to 'twenty three we will be investigating that further as trials designs become more formative and we'll communicate that to the investment can moody over the next couple of months.
Okay. Okay fantastic. Thanks, again for taking my questions I appreciate it.
Thank you.
As a reminder to star one on your telephone keypad, if he would like to ask your question.
For a brief moment to poll for any final questions.
Okay.
There are no more questions at this time I would like to turn the conference back over to management for closing comments.
Well, thank you very much for attending our first.
Quarterly earnings call.
I'm real proud of the team and their processes are undertaken over the last couple of months to come to these adjustments to our clinical plans I'm real excited about the potential we're looking forward to updating you again in the May quarterly conference call.
Thank you.
Thank you. This does conclude today's conference you may disconnect. Your lines at this time and thank you for your participation.
Okay.
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