─Accelerated Phase 2 CM-101 PSC Trial
Timeline with Topline 15-Week Data Now Planned for Midyear 2024
and Topline Open Label Data Expected in Late 2024/Early
2025─
─Cash Runway Extended through End of First
Quarter 2025 as a Result of Early Completion of Phase 2 PSC
Trial and Effective Financial Management─
─2023 Achievements Position Chemomab for a
Potentially Transformational 2024─
TEL AVIV,
Israel, March 7, 2024 /PRNewswire/ -- 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,
today announced financial and operating results for the full year
and fourth quarter ended December 31,
2023, and provided a corporate update.
"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.
About Chemomab Therapeutics
Ltd.
Chemomab is a clinical stage biotechnology company
developing innovative therapeutics for fibro-inflammatory diseases
with high unmet need. Based on the unique and pivotal role of CCL24
in promoting fibrosis and inflammation, Chemomab developed CM-101,
a monoclonal antibody that neutralizes CCL24 activity. In clinical
and preclinical studies, CM-101 appears safe, with the
potential to treat multiple severe and life-threatening
fibro-inflammatory diseases. Chemomab has reported positive results
from three clinical trials of CM-101 in patients, including a Phase
2a liver fibrosis trial in NASH patients and an
investigator-initiated study in patients with severe lung injury. A
Phase 2 trial in primary sclerosing cholangitis has completed
patient enrollment, with topline data expected midyear 2024.
Chemomab's CM-101 program for the treatment of systemic sclerosis
is Phase 2-ready. For more information about Chemomab, visit
chemomab.com.
Forward Looking Statements
This press
release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act. These forward-looking
statements include, among other things, statements regarding the
clinical development pathway for CM-101; the expectation that
Chemomab will report topline data from the PSC clinical trial by
mid-year 2024; the length, duration and impact of the war in
Israel on Chemomab's business and
operations; the future operations of Chemomab and its ability to
successfully initiate and complete clinical trials and achieve
regulatory milestones; the nature, strategy and focus of Chemomab;
the development and commercial potential and potential benefits of
any product candidates of Chemomab; and that the product candidates
have the potential to address high unmet needs of patients with
serious fibrosis-related diseases and conditions. Any statements
contained in this communication that are not statements of
historical fact may be deemed to be forward-looking statements.
These forward-looking statements are based upon Chemomab's current
expectations. Forward-looking statements involve risks and
uncertainties. Because such statements deal with future events and
are based on Chemomab's current expectations, they are subject to
various risks and uncertainties and actual results, performance or
achievements of Chemomab could differ materially from those
described in or implied by the statements in this presentation,
including those found under the caption "Risk Factors" and
elsewhere in Chemomab's filings and reports with the SEC. Chemomab
expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in Chemomab's expectations
with regard thereto or any change in events, conditions or
circumstances on which any such statements are based, except as
required by law.
Contacts:
Media and Investors:
Barbara Lindheim
Consulting Vice President, Investor & Public Relations,
Strategic Communications
Phone: +1 917-355-9234
barbara.lindheim@chemomab.com
IR@chemomab.com
Consolidated
Balance Sheets
|
In USD thousands
(except share and per share amounts)
|
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
|
2023
|
|
2022
|
Assets
|
|
Unaudited
|
|
Audited
|
|
|
|
|
|
Current assets
|
|
|
|
|
Cash and cash
equivalents
|
|
9,292
|
|
13,519
|
Short-term bank
deposit
|
|
10,492
|
|
26,374
|
Restricted
cash
|
|
76
|
|
77
|
Other receivables and
prepaid expenses
|
|
1,037
|
|
1,766
|
|
|
|
|
|
Total current assets
|
|
20,897
|
|
41,736
|
|
|
|
|
|
Non-current assets
|
|
|
|
|
Long-term prepaid
expenses
|
|
559
|
|
733
|
Property and equipment,
net
|
|
303
|
|
367
|
Operating lease
right-of-use assets
|
|
392
|
|
227
|
|
|
|
|
|
Total non-current assets
|
|
1,254
|
|
1,327
|
|
|
|
|
|
Total assets
|
|
22,151
|
|
43,063
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
Trade
payables
|
|
516
|
|
1,688
|
Accrued
expenses
|
|
3,423
|
|
3,378
|
Employee and related
expenses
|
|
825
|
|
1,560
|
Operating lease
liabilities
|
|
76
|
|
123
|
|
|
|
|
|
Total current liabilities
|
|
4,840
|
|
6,749
|
Non-current liabilities
|
|
|
|
|
Non-current operating lease
liabilities
|
|
316
|
|
91
|
Total non-current liabilities
|
|
316
|
|
91
|
|
|
|
|
|
Commitments and contingent
liabilities
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
5,156
|
|
6,840
|
|
|
|
|
|
Shareholders' equity (*)
|
|
|
|
|
Ordinary Shares no par
value - Authorized: 650,000,000 Ordinary Shares
as of December 31, 2023 and 2022;
|
|
|
|
|
Issued and outstanding:
284,094,700 Ordinary shares at December 31,
2023 and 232,636,700 Ordinary shares at December 31,
2022
|
|
-
|
|
-
|
Treasury share at cost
(11,640,460 shares as of December
31, 2022)
|
|
-
|
|
(1,218)
|
Additional paid-in
capital
|
|
105,675
|
|
101,260
|
Accumulated
deficit
|
|
(88,680)
|
|
(63,819)
|
|
|
|
|
|
Total shareholders' equity
|
|
16,995
|
|
36,223
|
|
|
|
|
|
Total liabilities and shareholders'
equity
|
|
21,151
|
|
43,063
|
|
(*) 1 American
Depositary Share (ADS) represents 20 Ordinary Shares
|
Consolidated
Statements of Operations
|
In USD thousands
(except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
Three months
|
|
Three months
|
|
Year
|
|
Year
|
|
Ended
|
|
Ended
|
|
Ended
|
|
Ended
|
|
December 31,
|
|
December 31,
|
|
December 31,
|
|
December 31,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
Unaudited
|
|
Unaudited
|
|
Unaudited
|
|
Audited
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
3,097
|
|
5,895
|
|
18,381
|
|
16,977
|
|
|
|
|
|
|
|
|
General and
administrative
|
751
|
|
2,747
|
|
7,078
|
|
11,556
|
|
|
|
|
|
|
|
|
Total operating expenses
|
3,848
|
|
8,642
|
|
25,459
|
|
28,533
|
|
|
|
|
|
|
|
|
Financing income,
net
|
(431)
|
|
(380)
|
|
(1,238)
|
|
(353)
|
|
|
|
|
|
|
|
|
Loss before taxes
|
3,417
|
|
8,262
|
|
24,221
|
|
28,180
|
Taxes on income
(Benefit)
|
-
|
|
10
|
|
-
|
|
(534)
|
|
|
|
|
|
|
|
|
Net loss
|
3,417
|
|
8,272
|
|
24,221
|
|
27,646
|
Basic and diluted loss
per Ordinary Share*
|
0.013
|
|
0.036
|
|
0.103
|
|
0.121
|
Weighted average number
of Ordinary Shares
outstanding, basic, and diluted*
|
260,274,470
|
|
230,966,824
|
|
234,998,859
|
|
227,589,288
|
|
(*) 1 American
Depositary Share (ADS) represents 20 Ordinary Shares
|
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SOURCE Chemomab Therapeutics Ltd