|
Exhibit
|
Description
|
|
|
|
|
|
CHEMOMAB THERAPEUTICS LTD.
|
|
|
|
|
|
|
Date: May 15, 2025
|
By:
|
/s/ Sigal Fattal
|
|
|
|
Sigal Fattal
|
|
|
|
Chief Financial Officer
|

| • |
On May 5, 2025, Chemomab announced that data from the company’s Phase 2 SPRING trial of nebokitug in PSC was presented in an oral Distinguished Abstract Plenary
session at Digestive Disease Week® (DDW 2025) in San Diego, California. The DDW 2025 session presented data from the double-blind, placebo-controlled 15-week treatment period and the 48-week open label extension portion of the study.
|
| • |
On April 28, 2025 Chemomab reported data from two study abstracts that were presented as posters at EASL 2025, the Annual Congress of the European Association for the
Study of the Liver. In one study, comprehensive proteomic analyses of 3,000 circulating proteins in patient samples from the Phase 2 SPRING trial showed that nebokitug-treated patients exhibited significant and dose-dependent changes in
proteins playing a key role in fibrosis, immune cell recruitment and inflammation. Nebokitug-treated patients showed reductions in multiple proteins, including those involved in downregulation of biological processes related to
fibrosis and inflammation. The authors highlighted how nebokitug’s ability to neutralize CCL24 exerts a wide impact, including reductions in a broad array of inflammatory and fibrotic biomarkers in treated patients. The second study
analyzed the pharmacodynamics and pharmacokinetics (PK) of nebokitug and CCL24 using data from the SPRING trial. PK analyses indicated effective antibody-target engagement, and linear regression analyses found trends between increasing
patient exposure to nebokitug and decreasing levels of PSC disease biomarkers.
|
| • |
On April 15, 2025, Chemomab announced new medical and clinical appointments. David M. Weiner, MD, rejoined Chemomab as Interim Chief Medical Officer, binging
extensive biotechnology and pharmaceutical industry R&D, drug development and strategic experience, and Jack Lawler, who oversaw the conduct of Chemomab’s successful Phase 2 SPRING Trial in PSC, was promoted to the position of Chief
Development Officer.
|
| • |
On March 27, 2025, Chemomab announced positive results from the Open Label Extension (OLE) portion of the Phase 2 SPRING trial of nebokitug in PSC. The OLE study
confirmed that the drug was safe and well-tolerated in PSC patients for up to 48 weeks and resulted in positive effects, including continued improvements in key liver biomarkers such as the ELF score, the fibrosis-related components of ELF
and the fibrosis biomarker PRO-C3. Liver stiffness scores as measured by FibroScan® were substantially lower in the nebokitug-treated patients with moderate/advanced disease compared to historical controls. Cholestasis-related markers
stabilized over 48 weeks of treatment and total serum bile acids were reduced. Importantly, OLE patients with moderate/advanced disease treated with nebokitug for 48 weeks showed a significantly lower number of clinical events compared to
historical controls.
|
| • |
On March 6, 2025, Chemomab announced a new scientific presentation at the 8th International Congress on Controversies in Rheumatology and Autoimmunity (CORA 2025)
that further confirmed the potential of nebokitug as a novel treatment for systemic sclerosis. The new data added to the extensive body of preclinical evidence that CCL24 is a key driver of the skin, lung and vascular manifestations of this
disabling condition that lacks disease-modifying therapies.
|
| • |
On February 19, 2025, Chemomab announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) and alignment with
FDA on the design of a Phase 3 registration study for nebokitug for the treatment of PSC. The design provides clarity on a streamlined path to full regulatory approval based on a single pivotal trial that does not require liver biopsies or
confirmatory studies. The primary endpoint measures time-to-first clinical event and encompasses multiple clinical events associated with disease progression. Key publications have shown that the reductions in PSC biomarkers seen in the
nebokitug Phase 2 SPRING trial are associated with reductions in clinical events, increasing confidence in the relevance of this approach for the nebokitug Phase 3 trial.
|
| • |
On February 19, 2025, Chemomab reported that the International Nonproprietary Names (INN) program of the World Health Organization had assigned the INN designation
nebokitug to the company’s lead product candidate CM-101.
|
| • |
On January 13, 2025, a new peer-reviewed publication in the journal Cells
further confirmed the key role of the soluble protein CCL24 in driving the fibro-inflammatory pathologies underlying PSC, systemic sclerosis and other fibrotic diseases. The review describes the pivotal role CCL24 plays in initiating and advancing fibrotic processes, highlighting its impact on fibrotic, immune and vascular pathways. It also presented preclinical and
clinical evidence supporting the therapeutic potential of blocking CCL24 in diseases that involve excessive inflammation and fibrosis.
|
| ◾ |
Cash Position: Cash, cash equivalents and short-term bank
deposits were $10.6 million as of March 31, 2025, compared to $14.3 million as of December 31, 2024. This cash runway is expected to fund the company through the second quarter of 2026.
|
| ◾ |
Research and Development (R&D) Expenses: R&D expenses
were $2.5 million for the first quarter of 2025, compared to $3.1 million for the first quarter of 2024. The decrease in R&D expenses in the first quarter of 2025 compared to the first quarter of 2024 primarily resulted from the
continued winding down of activities related to the Phase 2 SPRING trial .
|
| ◾ |
General and Administrative (G&A) Expenses: G&A expenses were $1.0 million for the first quarter of 2025, compared to
$0.9 million for the first quarter of 2024. The increase in G&A expenses primarily reflects increases in share-based expenses.
|
| ◾ |
Net Loss: Net loss was $3.3 million, or a net loss of less than
$0.01 per basic and diluted ordinary share for the first quarter of 2025, compared to $3.9 million, or a net loss of less than $0.01 per basic and diluted ordinary share for the first quarter of 2024. The weighted average number of ordinary
shares outstanding, basic and diluted, was 456,149,916 (equal to approximately 22.8 million ADSs) for the first quarter of 2025.
|
| ◾ |
Liquidity and Capital Resources: Chemomab believes its existing
liquidity resources as of March 31, 2025 will enable it to fund its operations through the second quarter of 2026.
|
| ◾ |
Number of Issued and Outstanding Shares: As of March 31, 2025, the company had 377,256,460 Ordinary shares issued and outstanding (equal to 18,862,823 ADSs), compared to 377,132,220 (equal to
18,856,611 ADSs) as of December 31, 2024.
|
|
March 31,
2025
|
December 31,
2024
|
|||||||
|
Assets
|
||||||||
|
Current assets
|
||||||||
|
Cash and cash equivalents
|
8,338
|
6,071
|
||||||
|
Short term bank deposits
|
2,225
|
8,195
|
||||||
|
Restricted cash
|
140
|
76
|
||||||
|
Other receivables and prepaid expenses
|
1,274
|
1,698
|
||||||
|
Total current assets
|
11,977
|
16,040
|
||||||
|
Non-current assets
|
||||||||
|
Long term prepaid expenses
|
341
|
385
|
||||||
|
Property and equipment, net
|
237
|
250
|
||||||
|
Operating lease right-of-use assets
|
264
|
289
|
||||||
|
Total non-current assets
|
842
|
924
|
||||||
|
Total assets
|
12,819
|
16,964
|
||||||
|
Current liabilities
|
||||||||
|
Trade payables
|
490
|
666
|
||||||
|
Accrued expenses
|
1,365
|
1,563
|
||||||
|
Employee and related expenses
|
279
|
874
|
||||||
|
Operating lease liabilities
|
113
|
115
|
||||||
|
Total current liabilities
|
2,247
|
3,218
|
||||||
|
Non-current liabilities
|
||||||||
|
Operating lease liabilities - long term
|
179
|
209
|
||||||
|
Total non-current liabilities
|
179
|
209
|
||||||
|
Commitments and contingent liabilities
|
||||||||
|
Total liabilities
|
2,426
|
3,427
|
||||||
|
Shareholders' equity (*)
|
||||||||
|
|
||||||||
|
Ordinary shares no par value - Authorized: 4,650,000,000 shares as of March 31, 2025, and as of December 31, 2024;
Issued and outstanding: 377,256,460 Ordinary shares as of March 31, 2025 and 377,132,220 as of December 31, 2024;
|
||||||||
|
-
|
||||||||
|
Additional paid in capital
|
116,339
|
116,160
|
||||||
|
Accumulated deficit
|
(105,946
|
)
|
(102,623
|
)
|
||||
|
Total shareholders’ equity
|
10,393
|
13,537
|
||||||
|
Total liabilities and shareholders’ equity
|
12,819
|
16,964
|
||||||
|
Three months
|
Three months
|
|||||||
|
Ended
|
Ended
|
|||||||
|
March 31,
|
March 31,
|
|||||||
|
2025
|
2024
|
|||||||
|
Operating expenses
|
||||||||
|
Research and development
|
2,493
|
3,152
|
||||||
|
General and administrative
|
994
|
896
|
||||||
|
Total operating expenses
|
3,487
|
4,048
|
||||||
|
Financing income, net
|
164
|
180
|
||||||
|
Net loss for the period
|
3,323
|
3,868
|
||||||
|
Basic and diluted loss per Ordinary Share (*)
|
0.007
|
0.014
|
||||||
|
Weighted average number of Ordinary Shares outstanding, basic, and diluted (*)
|
456,149,916
|
284,151,752
|