On March 7, 2024 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), a clinical stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported financial and operating results for the full year and fourth quarter ended December 31, 2023, and provided a corporate update (Press release, Chemomab, MAR 7, 2024, View Source [SID1234640921]).
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"In 2023 Chemomab achieved great progress, positioning the company for what we believe could be major catalysts in 2024 and early 2025," said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. "The superb work of our clinical and medical teams enabled us to complete patient enrollment in our Phase 2 primary sclerosing cholangitis (PSC) trial ahead of schedule and move up the topline readout to midyear 2024. Building on the positive data we have reported from our Phase 2a clinical trial in patients with liver fibrosis, we expect a successful readout would be a potential major catalyst for Chemomab, providing the first substantial clinical proof-of-concept for CM-101 and affording us the potential to advance to a registrational trial in consultation with the FDA, with an End-of-Phase 2 meeting possible later this year. We also look forward to a second readout from the trial’s open label extension, expected in late 2024 or early 2025, which we believe will provide additional clinical data on longer-term safety and activity, as well as another potential catalyst. Additionally, I am proud that our team has accomplished so much while maintaining tight fiscal discipline. As a result, we have been able to extend our cash runway until the end of the first quarter of 2025."
Dr. Mor continued, "We started the year reporting positive safety and activity data from our Phase 2a trial in liver fibrosis patients, showing that CM-101 demonstrated consistent positive effects across a range of biomarkers associated with fibrosis and inflammation. Our multiple scientific presentations and publications during the year further confirmed the role of our CCL24 target in driving key fibro-inflammatory pathways and CM-101’s ability to interrupt these disease processes."
Dr. Mor added, "We are collaborating with thought leaders and advocates who are working to build consensus around the use of non-invasive biomarker and imaging endpoints that will facilitate the conduct of late-stage PSC clinical trials. We are encouraged by the emerging view that these regulatory changes are both feasible and essential to advance new treatments for this rare orphan disorder that currently lacks any FDA-approved therapies."
Dr. Mor concluded, "The success of our Phase 2 PSC trial would be transformational for Chemomab, potentially allowing us to advance into a Phase 3 trial and to initiate additional clinical trials in other indications. We invite you to attend our upcoming webinar on Breaking New Ground: Expert Perspectives on Primary Sclerosing Cholangitis scheduled for April 10, 2024, and look forward to reporting on our further progress during the year."
2023 and Recent Highlights:
In January, 2024, Chemomab reported publication of new proteomics research in the peer-reviewed journal Cells reinforcing the clinical potential of CM-101 in primary sclerosing cholangitis.
In January, 2024, Chemomab announced early completion of patient enrollment in the CM-101 Phase 2 PSC SPRING trial and moved up the expected topline data readout to midyear 2024.
In November, 2023, Chemomab presented new data at ACR Convergence 2023 further confirming that its CCL24 target is a major driver of the fibrotic and inflammatory processes underlying systemic sclerosis (SSc) and other fibro-inflammatory diseases.
In November, 2023, Chemomab announced that CM-101 had received FDA Fast Track designation for the treatment of PSC in adult patients.
In November, 2023, at AASLD’s The Liver Meeting 2023, Chemomab hosted several presentations. An oral presentation of new proteomic patient data highlighted the unique association of the company’s CCL24 target with key PSC pathways and provided further evidence that CM-101 ameliorates these damaging effects.
In June, 2023, Chemomab announced a new publication in the peer-reviewed journal JCI Insight demonstrating the key role of CCL24 in PSC and presenting data showing how CM-101 interrupts the fibro-inflammatory processes underlying the disease.
In June, 2023, at the 2023 EASL Congress, Chemomab hosted a late-breaking presentation reporting new positive data from its CM-101 Phase 2a liver fibrosis trial.
In June, 2023, Chemomab announced that Adi Mor, PhD, had been reappointed to the role of Chief Executive Officer. Sigal Fattal was reappointed as Chief Financial Officer. Nissim Darvish, MD, PhD, was appointed Chairman of the Board. The company also announced that it was implementing cost-reduction measures that extended its cash runway to the end of 2024.
In June, 2023, Chemomab presented patient data at the 2023 EULAR Congress showing that serum CCL24 levels can predict the vascular and fibrotic complications of systemic sclerosis.
In May, 2023, Chemomab presented data at the 2023 EASL Biliary Conference reinforcing the pro-inflammatory role of CCL24 in PSC and other cholestatic diseases.
In February, 2023, Chemomab received FDA IND clearance for a CM-101 Phase 2 trial in SSc patients. Chemomab has not yet initiated patient enrollment in this trial.
In January, 2023, Chemomab reported topline results from its Phase 2a Liver Fibrosis trial in NASH patients demonstrating that CM-101 met its primary endpoint of safety and tolerability and showed positive activity across multiple liver fibrosis biomarkers and physiologic assessments.
Full Year and Fourth Quarter 2023 Financial Highlights:
Cash Position: Cash, cash equivalents and short-term bank deposits were $19.9 million as of December 31, 2023 compared to $39.9 million as of December 31, 2022.
Research and Development (R&D) Expenses: R&D expenses were $3.1 million for the fourth quarter and $18.4 million for the full year ended December 31, 2023, compared to $5.9 million and $17.0 million for the respective periods in 2022. The decrease in R&D expenses in the fourth quarter of 2023 compared to the fourth quarter of 2022 figure primarily resulted from the early completion of patient enrollment in the company’s CM-101 Phase 2 PSC trial.
General and Administrative (G&A) Expenses: G&A expenses were $0.8 million for the fourth quarter and $7.1 million for the full year ended December 31, 2023, compared to $2.7 million and $11.6 million for the fourth quarter and full year in 2022. The decrease in G&A expenses reflected selected reductions in headcount, and reductions in share-based payments and recruitment costs.
Net Loss: Net loss was $3.4 million, or a net loss of $0.01 per basic and diluted Ordinary Share, for the fourth quarter and $24.2 million, or a net loss of $0.10 per basic and diluted Ordinary Share for the year ended December 31, 2023, compared to a net loss of $8.3 million, or a net loss of $0.04 per basic and diluted share, for the fourth quarter of 2022 and $27.6 million, or a net loss of $0.12 per basic and diluted Ordinary Share, for the full year ended December 31, 2022.
The weighted average number of Ordinary Shares outstanding, basic and diluted was 234,998,859 (equal to 11,749,943 ADSs) for the year ended December 31, 2023, and 227,589,288 (equal to 11,379,464 ADSs) for the year ended December 31, 2022, respectively.
For further details on the company’s financial results for the year ended December 31, 2023, please refer to the company’s annual report on Form 20-F, which will be filed with the SEC later this month.