CMMB | Chemomab Therapeutics Ltd. | earnings call 2026-09-10
Verbatim transcript (source: faster-whisper-small.en)

Greetings and welcome to the Chemomap Therapeutics and Cypher Medicine merger announcement conference call. At this time, all participants are on a listen-only mode. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Barbara Lindheim, head of Strategic Communications and Investor Relations for Chemomap. Thank you. Please go ahead. Good morning, and thank you for joining today's conference call to discuss the merger agreement between Chemomap Therapeutics and Cypher Medicine. The link to this webcast is available at the Investors page of the Chemomap website and at the homepage of the Cypher corporate website. There will also be a presentation deck containing information relevant to the merger posted on the Chemomap and Cypher websites shortly. Before we begin, I would like to remind you that today's discussion will contain forward-looking statements regarding Chemomap, Cypher, the proposed merger, the concurrent financing, the expected ownership and leadership of the combined company, the anticipated use of proceeds and runway, and the planned development of Novocatog for rheumatoid arthritis. Certain statements in this conference call, other than purely historical information, may constitute forward-looking statements within the meaning of the Federal Security's laws, including for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the party's current knowledge and their present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These forward-looking statements involve a number of risks, uncertainties, some of which are beyond the combined company's control, or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, and those uncertainties and factors described under the heading Risk Factors in Chemomap's annual report on Form 20F for the year ended December 31, 2025, and Chemomap's other filings from time to time with the SEC. Nothing in this conference call should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The combined company does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. I will now turn the call over to Dr. Adee Moore, co-founder and chief executive officer of Chemomap's Therapeutics. Adee, please go ahead. Thank you, Barbara. It's a pleasure to be here today with Reg to discuss this important new chapter for Chemomap, Cypher, and our investors. I believe that the proposed merger of our companies has the potential to benefit our shareholders and the millions of patients in need of better therapies for serious conditions involving inflammation and fibrosis. This transaction is the culmination of a comprehensive review of strategic alternatives by Chemomap's board and management team. We assessed many potential partnering opportunities to advance our lead asset in the Bokeh Tag over the years and feel confident that the merger with Cypher, a leader in AI-powered precision medicine and the planned development of the Bokeh Tag as a novel precision medicine for macular trices are the best options going forward. As we announced this morning, Chemomap and Cypher Medicine have entered into a definitive agreement under which the companies will combine in an all-stock transaction. Upon closing, the combined company is expected to operate as Cypher Medicine Corporation and trade on NASDAQ under the ticker symbol SCIP. Dr. Reg Sito, Cypher's chief executive officer, would lead the combined company and I am very pleased to join the combined company's board of directors. From a transaction perspective, pre-merger Chemomap stockholders are expected to own approximately 32% of the combined company and pre-merger Cypher stockholders are expected to own approximately 68% prior to giving effect to the concurrent financing which is expected to dilute both parties' prorata. Chemomap stockholders will also receive contingent value rights, CVRs, providing the opportunity to realize additional value upon achievement of specific milestones subjected to the terms of the CVR agreement. Importantly, the transaction is supported by a committed 30 million private placement from Cypher's existing investor syndicates of top-tier biotech investors, including Northpond Ventures, Cosla Ventures, Blue Owl Healthcare Opportunities, Norburger, Berman, and others, which together with the revenues from Cypher's growing precision medicine business is expected to fund the combined company through the planned readout of an Abocitag phase two trial in patients with rheumatoid arthritis in the first half of 2028. The transaction has been unanimously approved by the boards of directors of both companies and is expected to close in the fourth quarter of 2026 subjected to required approval and customary clothing conditions. At Chemomap, we developed Nebocitag, a first-in-class anti-CCL24 antibody with a dual anti-inflammatory and anti-fibrotic mechanism of action and therapeutic potential across a broad range of inflammatory and fibrotic diseases where CCL24 biology plays a major role. We initially focused on rare diseases, successfully completed the phase two spring trial in primary cirrhosincholangitis, which established clinical proof of concept and validated the role of our CCL24 target as an important contributor to the fiber and inflammatory disease cycle. Over 48 weeks of treatment, Nebocitag demonstrated a favorable safety profile with no serious treatment related adverse events. Importantly, treatment with Nebocitag resulted in improvements in anti-inflammatory and anti-fibrotic endpoint across a range of relevant disease biomarkers. Nebocitag has now been administered to more than 100 patients across five different clinical studies consistently demonstrating a favorable safety profile and evidence of therapeutic activity. What makes this proposed merger so compelling is the strong science and precision medicine-based, their risking strategy powering the Nebocitag clinical program in rheumatoid arthritis. Cypher has developed and has deep expertise in rheumatoid arthritis. It developed and markets PrismRA, the only CMS-approved test for RA patients that predict treatment response. It is designed to identify the sizable population of patients with rheumatoid arthritis who do not benefit from the TNF inhibitor blockbuster drugs that currently dominate the RA market. Cypher's independent analysis powered by its rich AI precision medicine platform identified CCL24 inhibition as the top-ranked clinical stage therapeutic opportunity for RA, strongly validating the strategic rationale for combining Cypher's platform with Chemomab's CCL24 program. As a first-in-class anti-CCL24 antibody with favorable safety and positive evidence of anti-inflammatory and anti-fibrotic activity in a phase two trial, Nebocitag was understandably an attractive option. I also want to note that the Chemomab research team who pioneered the study of CCL24 as a powerful driver of inflammation and fibrosis believe there is considerable evidence for the therapeutic potential of Nebocitag in rheumatoid arthritis and our clinical studies to date have shown activity in biomarkers and pathways that directly shows relevance to the RA disease process. We believe this transaction provides Chemomab stockholders with meaningful ownership in a combined company that is well-funded to advance Nebocitag into a large indication with substantial unmet needs with well-established clinical endpoints and at the risking precision medicine clinical strategy. By applying precision medicine to patient selection, we believe this strategy has the potential to substantially derisk the study and increase the probability of clinical success. And for many of our stakeholders who supported the development of Nebocitag as a potential treatment for primary sclerosis cholangitis, the opportunity remains for further partnering in this indication. I will now turn the call over to Reg Sito, Chief Executive Officer of Cypher. Reg. Thank you Adi and good morning everyone. I want to begin by explaining why Cypher pursued this transaction and why we believe the combination of Cypher's precision medicine platform and Chemomab's anti-CCL24 antibody creates a unique and differentiated opportunity in rheumatoid arthritis, a 24 billion global market size that leaves far too many patients inevitably treated today. First, for those who are new to Cypher, a few words about my background and why I decided to join Cypher. Trained as a physician scientist, I'm a global biopharmaceutical and diagnostic CEO and board director with a deep and varied background in building growth companies across both biopharma and diagnostics. Two years ago, before joining a Cypher CEO, the board and I agreed there would be the opportunity and support to evolve Cypher into a therapeutics company. What I saw in Cypher was a company that built an incredible transformative technology that could predict the patient's response to drug treatment. This was highlighted by Prisma Ray, the only approved CMES molecular treatment response to the gene immunology. What was clear to me in 2024 and is just as clear now, is that the greatest potential impact the Cypher's proprietary AI network medicine platform will be during drug development. We should be able to understand which patients respond to a drug during a time when it is developed, not after approval, especially in immunology where the failure rate is high. Oncology has already demonstrated the power of precision medicine and has successfully targeted patients with high response rates during drug development. This has led to more choices with the right treatments for patients and their physicians. Ultimately, I see Cypher as the next generation of precision medicine as we target treatment response using multimodal and multi-omic signatures. I thank Cypher's board for their support in beginning to make this decision into reality. Second, in immunology and rheumatology, there remains a significant unmet need with current treatments as both a physician and an immunology patient. I'm aware of the limitations of our current approach, which lies too much in trial and error. As a result, two out of three patients in RA today did not achieve low disease activity or remission. Immune-media diseases are chronic and we need treatments that can achieve low disease activity and remission. On behalf of immunology patients across the world, I believe Biopharmic can do much better and that the technology to advance this vision now exists through Cypher. Beyond being a patient, what makes my perspective truly unique is my deep experience in both precision medicine and therapeutics. This is why the combination of Chemomab, a clinical stage company that is a novel safe and well-tolerated asset with a first-in-class mechanism of action with demonstrated anti-inflammatory and anti-fibrotic activity, and Cypher, a company known for its pioneering work in precision medicine, makes so much sense. Before joining Cypher, I was the CEO of KDX, a leading precision medicine public company in transplant medicine, where we rapidly expanded by building a differentiated set of novel diagnostics and created a future platform for growth with data and digital solutions. Part of this, I held executive roles at large, mid-size, and small therapeutic companies across all functions, ranging from business development, clinical, commercial, and corporate strategy. These include being the Chief Operating Officer at Adelex, Executive Vice President Corporate Development Strategy at Medimmune, the Biologics Division at Vastra Zeneca, and in senior commercial roles at Organon and Burrowing Ingle Home. Turning now to the Novogadog opportunity for Cypher and Chemmab. We have four topics to cover. First, I'd like to describe Cypher's technology, including our RA assets, and why we focus on RA as our first commercial opportunity. Second, I'll discuss why Novogadog was our first choice to develop an RA. Third, I'll outline the clinical development plan and our precision medicine approach. And fourth, I'll finish by noting how we are financing and funding the Novogadog opportunity. Now on to Cypher. Cypher was built around the conviction that precision medicine can transform immunology in the way it has transformed oncology. We spent years developing spectra, our AI network medicine platform, which integrates large-scale transatomic data and network biology to identify molecular treatment response signatures and support target selection in complex immune-mediated diseases. The commercial proof point for this approach is PRISM-RA, the first and only CMS-approved molecular treatment response signature, designed to help guide targeted therapy selection in rheumatoid arthritis. PRISM-RA has already been ordered by more than 1,700 rheumatologists and used in over 45,000 individual patients. In real-world data submitted to CMS, PRISM-RA guided patients achieve low disease activity at a two times higher rate and remission at a three times higher rate than external controls receiving standard care treatment with statistical significance across reported outcomes. As we look at entering the therapeutic development arena, we focus on RA opportunities given the large $24 billion plus global market in which about two thirds of patients fail to achieve low disease activity with current therapy. Additionally, there's been limited innovation in the field with the last novel drug mechanism for RA approved in 2012. Notably, there are currently no novel RA drugs in phase three development in the United States. If successful, this program could deliver the newest novel therapeutic in RA since 2012 and become the first precision medicine approval in rheumatoid arthritis. As noted, RA affects millions of patients globally and is currently characterized by trial and error prescribing. Even worse, the current market leading therapies has safety issues and include black box warnings. We believe RA patients deserve better treatment options and more precisely targeted treatment disease. No one decides to assessment a CCL-24 and its role in RA. We believe using molecular treatment response signatures to guide treatment selection improves RA treatment decision making and provides a real-world foundation that ciphers broader precision medicine strategies. We use our platform to systematically identify current targets in clinical stage development to those predicted to have the highest efficacy response. Across our analysis, CCL-24 emerged as the leading target. The Bogota's anti-CCL-24 mechanism of action ranked in the top 1% of targets analyzed on our clinical platform for predicted RA efficacy, providing a strong biological rationale for the clinical advancement of CCL-24 blockade by the Bogota and in precision medicine selected RA population. Next, we looked at external validation by both hema-mab and third-party list to evidence. Hema-mab's phase two spring trial showed that the Bogota produced statistically significant reductions in key inflammatory and fibrotic biomarkers in moderate to advanced PSC patients. These biomarkers that are directly relevant to the inflammatory and fibrotic pathways driving RA disease. Importantly, it showed a favorable safety profile that's been administered in five trials with over 100 treated patients. There was considerable external evidence supporting the role of CCL-24 and CCL-24 blockade in RA, including preclinical animal models. In addition, recent independent publications have further reinforced the mechanistic rationale, including reports that CCL-24 is upregulated in arthritis patients, and CCL-24 promotes fibrosis through the CCR3 TGF beta pathway. Earlier this year, a nature immunology publication demonstrated TGF beta agonist fibro- fibro- signaling, which is directly impacted by CCL-24, is a key driver of treatment refractory RA. In general, the fibrosis component of RA has not been directly addressed by current therapies, and we are excited to assess the impact of the Bogota with its anti-fibrotic activity on the disease. Taken together, SIFAS platform analysis, the clinical biomarker data, and the external literature all support our confidence in advancing this program into RA. Now on to SIFAS clinical development planning, incorporating precision medicine. We believe SIFAS is well positioned to execute this development program because we have built unique RA capabilities. We have RA-specific clinical infrastructure, including over 30 clinical sites recently participating in our PREDICT trial, which was designed to expand our RA precision medicine test menu. We have an established care-water relationship within the rheumatology community, and we have an efficient commercial team that can be scaled rapidly. In addition, we have both a CAHPS and clear certified laboratory in North Carolina, where the PRISM RA assay is analyzed. The plan phase two trial is designed to use PRISM RA to pre-screen and identify the two-thirds of patients who don't achieve low disease activity and or remission with TNF inhibitors, the current standard of care in first-line treatment. We believe the Bogadox mechanism action has potential to show a differentiated benefit in this patient population, especially with its dual anti-inflammatory and anti-fibrotic activity. Again, as a reminder, we know that in most refractory RA patients, the disease is driven by ongoing fibrosis. The plan study uses well-established RA endpoints, including the composite ACR20 index, which measures the efficacy of RA patient treatments at week 12 as the primary endpoints, along with standard secondary endpoints. The primary goal is to demonstrate that the Bogadox can achieve standalone efficacy on the ACR20. The study plan itself enrolls approximately 140 patients at global sites across two dosing cohorts and a placebo cohort. We currently expect to submit the pre-ID package in the second half of 2026 and subject to regulatory feedback, those the first patient in the first quarter of 2027. With top-line phase two data anticipating the first half of 2028. Beyond screening for this enrollment eligibility, SISRA identified a preliminary CCL24 biomarker response signature. We believe this signature can further stratify patients, most likely response to Bogadox. Following completion of this phase two study, we plan to use the patient samples collected during the trial to fully validate the CCL24 biomarker signature with the goal of supporting a companion diagnostic strategy for the phase three program. In essence, we're taking a two-stage precision medicine approach to de-risk development. First, we use PRISM-RA to identify TNF non-responders. Second, we apply the CCL24 specific response signature to enrich the patients most likely to benefit from the Bogadox in phase three. Together, these steps create a true precision medicine approach, a strategy that's designed to maximize patient benefit and also increase the probability of clinical success. This is the model that has driven the most successful precision medicine approvals in oncology, pairing a novel drug and its companion diagnostic that would develop and validate together. Now on to financing, funding and key milestones. We're proud that Cypher is supported by top tier biotech investors who are committing 30 million in a pipe financing. The new funds, along with Cypher's precision medicine revenues, are expected to fund the combined company through the planned top line phase two readouts in the first half of 2020, which we view as a key near-term potential value inflection point for our investors. So in summary, we believe a precision medicine developed approach using a first-in-class anti-CCL24 therapy with a demonstrated safety profile and a very distinctive dual action with anti-inflammatory anti-fibroxy mechanism to represent a differentiated option for many RA patients whose disease remains active despite current therapies, as this will provide a first new option for newly diagnosed, also new options and newly diagnosed RA patients. So in closing, I want to thank the Chemimab team and their board for their confidence in Cypher and for their commitment to bringing the Bogotas to this next chapter of development. We believe the combined company will have a rare set of assets, a validated data-rich AI-powered precision medicine platform for drug development and a revenue-generating commercial RA precision medicine diagnosis business, including infrastructure. We'll have a clinically validated first-in-class anti-CCL24 antibody with good safety and therapeutic potential across multiple, multiple inflammatory and fibrotic conditions, including RA, with a true medicine development strategy approach linking phase two biomarker data to companion diagnostic. This will set the stage for potentially de-risk phase two programming RA. And we've committed financing to reach our major phase two data readouts and central inflection points for new companies. We look forward to working closely with ARDI and the Chemimab team as we complete the transaction and advance towards this trial initiation. I will now turn the call back to the operator. Ladies and gentlemen, thank you for your participation and interest in Chemimab and Cypher. This concludes today's presentation. You may disconnect or log off at this time and enjoy the rest of your day.