Chemomab Therapeutics Ltd (CMMB) 2021 Q4 法說會逐字稿

Greetings. Welcome to Chemomab's fourth-quarter and full-year 2021 earnings call. (Operator Instructions) Please note this conference is being recorded.

I will now turn the conference over to Barbara Lindheim, Vice President of Investor Relations. Thank you. You may begin.

Welcome to the Chemomab Therapeutics 2021 fourth-quarter and full-year results conference call. Thank you for attending.

I am Barbara Lindheim, Consulting Vice President of Communications at Chemomab. With me today are Dale Pfost, our Chairman and CEO; Don Marvin, CFO, Chief Operating Officer and the Executive Vice President; Dr. David Wiener, Chemomab Interim Chief Medical Officer; and Dr. Adi Mor, our Co-Founder and Chief Scientific Officer.

Before I turn 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. 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.

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 in 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 headings in the other reports and materials we filed with the SEC.

Except as required by federal security laws, Chemomab 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. Dale?

Welcome to the first Chemomab 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. I was impressed by the clinical and commercial potential of CM-101, our pipeline in the product focusing on indications at the confluence of inflammation and fibrogenesis, an area of great unmet medical need.

Also, by the rigorous translational and preclinical science produced by our Co-Founder and CSO, Dr. Adi Mor and her team, our lead clinical candidate, CM-101, is a monoclonal antibody that neutralizes CCL24, a unique target that has been validated in 11 preclinical model systems.

CM-101 has demonstrated good safety and pharmacokinetics and pharmacodynamics in two Phase 1 studies, in both healthy volunteers and patients, which further supports our belief that CM-101 has first-in-class potential in the two rare disease indications of primary sclerosing cholangitis or PSC, and systemic sclerosis, SSc, as well as in additional clinical indications.

I'm excited to be Chemomab's CEO, and now also chairman. I believe the company has a very bright future, and I look forward to sharing this progress with you.

First, an overview of our progress in 2021, which was an eventful year for Chemomab. Key accomplishments included, in February, we announced positive results from a Phase 1b trial in patients with nonalcoholic fatty liver disease, reporting that CM-101 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 March, Chemomab completed a merger transaction listed at ADRs on NASDAQ and closed a $45.5 million PIPE. As part of the merger and public listing, Chemomab expanded its Board of Directors, adding industry-savvy directors with business and clinical development expertise.

In April, we dosed the first patient in our CM-101 Phase 2 liver fibrosis biomarker at subcutaneous formulation study.

In June, the company expanded its partnership with AGC Biologics for final optimization and production of GMP manufacturing batches of CM-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 CM-101's target CCL24 in the vascular damage associated with systemic sclerosis.

In November, Don 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 Chemomab.

In December, we received approval from the FDA for our first US IND, aimed at expanding clinical activities in our PSC Phase 2 trial.

We were also fortunate to have had Dr. David Weiner join us as Interim CMO in December. Dave is an accomplished biotech senior executive, who is exceedingly well versed 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 CM-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 onboarding of our expanded senior management team, recent feedback from key global regulatory authorities, COVID's 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 CM-101 by decreasing overall risk in the clinical program, maximizing the clinical information obtained to facilitate decision making, generating critical data to support the advancement to registrational trials, and optimizing the overall clinical development plan for CM-101 in systemic sclerosis and PSC, as well as potentially in additional indications where the scientific rationale is strong. In short, we want to achieve biological and pharmacological validation for CM-101 sooner and prepare to advance to 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 clinically knowledgeable human lab directors, have recommended important modifications to the current clinical programs for CM-101. We believe this is good news and we're excited to share it 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 with an enlarged large clinical trial that adds an important dose-finding component; two, focusing on our systemic sclerosis clinical efforts on establishing earlier biological and clinical proof of concept for CM-101 in this indication; three, 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 that 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 outlined for rapidly generating informative data that will help drive the next steps in clinical programs while decreasing our capital requirements. And we estimate extending our cash runway by about six months through the end of 2023.

We intend to provide significant 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 Wiener, who will provide more background on the clinical rationale for the changes. Dave?

As Dale noted, the strategic review has resulted in a number of important changes to the CM-101 clinical development program. We initiated this review based on multiple relevant factors, most notably upon receipt of key feedback from global regulatory authorities. Today, 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 CM-101 development program by significantly expanding our Phase 2 trial for primary sclerosing cholangitis. We are currently exploring the safety, tolerability and importantly, the biomarker and clinical activity of 10 mgs per kilogram of CM-101 administered intravenously every 3 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 CM-101 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 the study to assess safety and biomarker 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 CM-101 in treating the skin, lung and vascular damage seen in systemic sclerosis patients.

The data obtained from this study can 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 2 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 and systemic sclerosis, we will be winding down our ongoing safety, tolerability and biomarker trial that is evaluating a 5-milligram per kilogram dose of the subcutaneous formulation of CM-101, in liver fibrosis patients. We will be halting screening and enrollment in the coming weeks.

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 CM-101's mechanism of action, providing additional data on the anti-inflammatory and anti-fibrotic activity of CM-101 in liver diseases.

Finally, a key objective of this study is to explore the safety and drug exposures associated with our subcu formulation. And we believe the early completion of this study should be sufficient to achieve this purpose, providing the pharmacokinetic data needed to assess our next steps in the development of the subcutaneous formulation of CM-101.

The proposed changes to the development program for CM-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, a complex rheumatologic disorder with both inflammatory and fibrotic components; to best inform the development path for a novel first-in-class therapeutic like CM-101; and to obtain relevant safety and tolerability data to support the evaluation of higher doses of CM-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. Don?

Good day. As CFO of Chemomab, I am pleased to have this opportunity to communicate directly with our shareholders and other stakeholders. Today, I will review highlights of our 2021 financial performance. Please 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 2022.

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 can be. However, I also know that down cycle's inevitably cycle to better times. And I believe this one will too. We cannot change the markets, but we can ensure that we are not distracted from focusing on what we need to do to build a successful company.

And for Chemomab management, that is to ensure we are pursuing the optimal development plan for CM-101, prudently managing our finances to achieve the greatest ROI on our investments, conserving capital to the extent feasible, while advancing our clinical programs in an as optimal fashion as possible and monitoring our ecosystem for potential opportunities to bring additional attractive assets in-house.

Let me now share a summary of 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 and $6.3 million for the full year ended December 31, 2021, compared to $1.3 million and $4.7 million for the same quarter end year in 2020.

G&A expenses were $2.6 million for the quarter and $6.0 million for the full year ended December 31, 2021, compared to $0.7 million and $1.3 million for the same quarter and year in 2020.

Net loss was $5 million or a net loss of $0.02 per basic and diluted share for the fourth quarter and $12.5 million or a net loss of $0.06 per basic and diluted share for the year ended December 31, 2021, compared to $2.6 million or a net loss of $0.02 per basic and diluted share for the quarter, and $6 million or a net loss of $0.04 per basic and diluted share for the full year ended December 31, 2020.

The weighted average number of ordinary shares outstanding basic and diluted are 207,468,650 and 136,755,498 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 CM-101. As noted, we expect these changes may allow us to achieve clinical validation sooner at less cost and with less risk of providing us more data readouts along the way and better positioning of CM-101 for subsequent registrational trials.

Since its inception, Chemomab has been characterized by a sufficient use of capital. And I'm pleased to report that we are upholding that tradition by ensuring we are continuing to work smarter and more efficiently in 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 costing less than the original plans.

As a result of these expected savings in clinical spend and our plans for continued prudent management of 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 provides us greater flexibility.

Another important initiative for 2022 is enhancing and extending our corporate and investor communication 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 road shows, social media outreach, KOL events and other special virtual and in-person investor activities as appropriate. We believe we have a compelling story to tell, and we'll work to ensure that it is more widely known and appreciated going forward.

In summary, we are excited about the therapeutic potential of CM-101 and the opportunities afforded by our revised clinical development program to achieve strong momentum at Chemomab over the rest of 2022 into 2023. We believe we have the opportunity to make a significant difference in patients' lives while continuing to build a vibrant and valuable company. 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. Dale?

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 see CM-101 has great potential as a 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 medical need and strong commercial potential.

We believe we are on the prudent and right path to building value at Chemomab. With our new plan over the next 24 months, we expect to generate more informative milestones and catalysts, be better positioned for potential registrational trials and achieve 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. This concludes our prepared remarks. Operator, we are ready for questions.

(Operator Instructions) Kristen Kluska, Cantor Fitzgerald.

Hi, good morning and good afternoon, everybody. Thanks for taking my question. They're on systemic sclerosis. So I wanted to ask -- I understand some of the endpoints could differ based on you wanting to look at a more holistic package of effects on the different organs 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 changes across inclusion, exclusion criteria to understand different levels of severity or looking at different doses to study as well as length of time? Or is it kind of all of the above at this point?

Yes, hi. It's kind of all of the above at this point. We have changed the goals of what we're trying to achieve in SSc, and we're moving towards an exploratory and clinical proof of concept. And we're going to do exactly that. We believe CM-101 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, it's just on the subcutaneous study. It 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 assuming that things read out positively, you're happy with the results, is the plan after these initial PSC and SSc studies to then consider moving into a subcutaneous trial?

So yes, we are continuing to explore the nonclinical 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 subcu formulation, that exposure and pharmacokinetic data will determine what our next steps in the clinical program are. And indeed, the goal here is to advance that such that it will be either usable in our registration programs or soon thereafter.

Got it. Thanks so much for taking my question.

Thank you.

(Operator Instructions) Nathan Weinstein, Aegis Capital.

Thank you. Good morning, Dale, Ari and the Chemomab team. So thanks so much for taking my questions. And the first one is just on PSC regarding -- including a higher dose. Just what gives you the confidence to include a higher dose in the revised trial?

I'm not exactly sure what you mean by confidence, but our desire here is to explore more than the single dose that we're currently interrogating in mgs per kg. The rationale is to add a lower dose and a higher dose. We believe that the 20 of the safety observed to date with CM-101 across all the populations, which is quite good, will support us advancing to the evaluation of the 20 mg 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 prospective 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 2023. We will be investigating that further as trials designs become more formative, and we'll communicate that to the investment committee over the next couple of months.

Okay. Okay, fantastic. Thanks again for taking my questions. Appreciate it.

Thank you.

(Operator Instructions) We will pause for a brief moment to pull for any final questions.

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 that they have 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.