─On Track to Achieve CM-101 PSC Phase 2
Readout Expected in 2H2024—
─Extended Estimated Cash Runway
Through PSC Readout and 2024 Year-End─
─Reported Positive Secondary Analysis
of Data from CM-101 Phase 2 Liver Fibrosis Trial─
─Successfully Implemented Senior Management
Changes and Cost Saving Measures─
─Published New Peer-Reviewed Articles and
Presented Scientific Posters at European Medical Meetings
Highlighting Therapeutic Potential of CM-101 for
Treating Fibro-inflammatory Diseases─
TEL
AVIV, Israel, Aug. 14,
2023 /PRNewswire/ -- Chemomab Therapeutics Ltd.
(Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company
developing innovative therapeutics to treat rare fibro-inflammatory
diseases with high unmet need, today announced financial and
operating results for the second quarter ended June 30, 2023, and provided a corporate
update.
"I am pleased to report that the company continued to make good
progress during the second quarter," said Adi Mor, PhD, co-founder, Chief Executive
Officer and Chief Scientific Officer of Chemomab. "In June, the
Board of Directors re-appointed me to the CEO position and
re-appointed then Vice President of Finance Sigal Fattal as Chief Financial Officer. Our
extensive prior experience in these roles and ongoing active
involvement in company management have made for a seamless
transition."
Dr. Mor continued, "During the quarter we sharpened our
corporate strategy. We extended our cash runway to take us through
the end of 2024 and the readout of topline results from our Phase 2
trial of CM-101 in patients with primary sclerosing cholangitis
(PSC), expected in the second half of 2024. Extension of the cash
runway was achieved by tightening our focus and selectively pruning
expenses. Enrollment in the PSC trial continues to go very well and
we are pleased to have the resources on-board to take us through
this major milestone. In addition, we are increasingly optimistic
about the potential prospects for the PSC program based on
additional positive biomarker data from our Phase 2 liver fibrosis
trial that may also be applicable to PSC. As part of our strategic
refresh, we suspended the planned start of our Phase 2 systemic
sclerosis (SSc) trial; however, we remain enthusiastic that CM-101
may have disease-modifying potential in this poorly-treated
condition and the SSc program remains fully Phase 2-ready."
Dr. Mor added, "The second quarter was notable for our many
scientific presentations at important European medical meetings
like EASL and EULAR. We also published a research article in a
respected peer-reviewed journal, JCI Insight. As a group,
the studies reinforce our extensive data highlighting the central
role of CCL24 in the pathophysiology of fibro-inflammatory diseases
and confirm that our CCL24-neutralizing antibody, CM-101, has
potential therapeutic utility in these conditions."
"Promising new data from secondary analyses of our Phase 2 liver
fibrosis trial in NASH patients was presented in a late-breaking
poster at the 2023 EASL Congress in July. The new results show
encouraging improvements in additional inflammatory and
fibrogenesis-related biomarkers. Overall, the improvements in
biomarkers seen in the Phase 2 liver fibrosis trial reinforce our
belief that these data may serve as a potential bridge to other
anti-fibrotic indications such as PSC, providing additional
evidence that CM-101 could be a valuable therapy for this
potentially fatal disease that lacks effective treatment
options."
Corporate Developments
Implemented Executive Changes
In June, Chemomab
announced that Adi Mor, PhD,
co-founder and former Chief Executive Officer (CEO), and then
Director and Chief Scientific Officer, had been reappointed to the
role of CEO, replacing Dale Pfost, PhD. Sigal Fattal,
former Chief Financial Officer (CFO) and then Vice President,
Finance, had been reappointed to the role of CFO,
replacing Donald Marvin. Nissim
Darvish, MD, PhD, was appointed Chairman of the Board,
replacing Dr. Pfost. All the appointments were effective June
1, 2023. The company also announced that it was implementing
additional cost-reduction measures that extend its cash runway from
mid-year 2024 to the end of 2024, after the expected topline data
readout from the Phase 2 CM-101 PSC trial.
Presented Data at 2023 EASL Biliary Conference Reinforcing
the Proinflammatory Role of CCL24 in Cholestatic Disease
In
a poster presentation at the 2023 EASL Biliary Conference in May,
researchers used patient proteomic and animal data to demonstrate
the proinflammatory role of CCL24 in cholestatic disease. In these
studies, CM-101 demonstrated an anti-inflammatory effect by
interfering with the migration of monocytes and neutrophils to the
damaged biliary area in a PSC animal model, thereby reducing
fibrosis and biliary hyperplasia.
Presented Patient Data at 2023 EULAR Congress
Showing that Serum CCL24 Levels Can Predict Vascular and Fibrotic
Complications of Systemic Sclerosis
In a poster presentation
at the 2023 EULAR European Congress of Rheumatology in June,
researchers presented results from a patient sample study
demonstrating that high serum levels of CCL24 were correlated with
SSc severity, including a higher incidence of fibrosis-associated
symptoms; a three-fold increased risk of interstitial lung disease
progression; and a shorter SSc-related 5-year survival time.
Reported Secondary Analyses of CM-101 Phase 2 Liver Fibrosis
Trial
In a late-breaking poster presentation at the 2023
EASL Congress in July, Chemomab reported secondary analysis data
from its Phase 2a liver fibrosis trial of CM-101 in patients with
non-alcoholic steatohepatitis (NASH). The data showed improvements
across an additional set of inflammatory and fibrotic biomarkers
that are consistent with the positive topline clinical results
Chemomab released in January. Additionally, in NASH patients at
greater risk of disease progression, CM-101 treatment resulted in a
greater biomarker response than in patients with lower risk disease
or in placebo-treated patients.
Reported Data Reinforcing the Clinical Potential of CM-101 as
a Novel Treatment for PSC
At the 2023 EASL Congress in July,
Chemomab presented two posters discussing the potential of CM-101
as a novel treatment for PSC. One of the posters reported on a new
proteomic study demonstrating a direct relationship between the
pro-inflammatory, pro-fibrotic activity of CCL24 and PSC
disease-related pathways. The other poster described the clinical
design of Chemomab's double-blind, placebo-controlled, multiple
dose Phase 2 trial of CM-101 in PSC patients.
Published Peer-Reviewed Research Article Demonstrating the
Key Role of CCL24 in PSC
This peer-reviewed research article
published in the June issue of JCI Insight was produced
through collaborations with prominent academic groups and supports
the key role of CCL24 in driving the self-perpetuating fibrosis and
inflammation that result in the severe liver damage characterizing
PSC.
Second Quarter 2023 Financial Highlights
- Cash Position: Cash, cash equivalents and short-term
bank deposits were $26.7 million as
of June 30, 2023, compared to
$32.8 million on March 31, 2023.
- Research and Development (R&D) Expenses: R&D
expenses were $5.0 million for the
second quarter ended June 30, 2023,
compared to $2.9 million for the same
quarter in 2022. The increase was primarily due to increased
clinical activities.
- General and Administrative (G&A) Expenses: G&A
expenses were $3.2 million for the
quarter ended June 30, 2023, compared
to $3.3 million for the same quarter
in 2022.
- Net Loss: Net loss was $8.0
million, or a net loss of approximately $0.04 per basic and diluted ordinary share for
the second quarter of 2023, compared to a net loss of $6.2 million, or a net loss of approximately
$0.03 per basic and diluted ordinary
share for the second quarter of 2022. The weighted average number
of ordinary shares outstanding, basic and diluted, was 221,674,130
(equal to approximately 11.1 million ADSs) for the quarter ended
June 30, 2023.
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
designed to neutralize CCL24 activity. In preclinical and clinical
studies, CM-101 appears safe, with the potential to treat multiple
severe and life-threatening fibro-inflammatory diseases. Chemomab
has reported encouraging results from three clinical trials of
CM-101 in patients, including a Phase 2 liver fibrosis trial and an
investigator-initiated study in patients with severe lung injury. A
Phase 2 trial in primary sclerosing cholangitis patients is
ongoing, with topline data expected in the second half of 2024. 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 future operations of Chemomab
and its ability to successfully initiate and complete clinical
trials and achieve regulatory milestones; the Company's cash
position and expectations regarding its ability to achieve the
topline data readout from the Phase 2 primary sclerosing
cholangitis (PSC) trial of CM-101 with its current cash; 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
|
Chemomab Therapeutics
Ltd. and its subsidiaries
|
Condensed
Consolidated Balance Sheets
|
In USD thousands
(except for share amounts)
|
|
|
|
|
|
|
|
June
30,
2023
|
|
December
31,
2022
|
|
|
|
|
|
Assets
|
|
Unaudited
|
|
Audited
|
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash and cash
equivalents
|
|
10,382
|
|
13,519
|
Short term bank
deposits
|
|
16,207
|
|
26,374
|
Restricted
cash
|
|
74
|
|
77
|
Other receivables and
prepaid expenses
|
|
1,042
|
|
1,766
|
|
|
|
|
|
Total current
assets
|
|
27,705
|
|
41,736
|
Non-current
assets
|
|
|
|
|
Long term prepaid
expenses
|
|
646
|
|
733
|
Property and equipment,
net
|
|
338
|
|
367
|
Operating lease
right-of-use assets
|
|
160
|
|
227
|
Total non-current
assets
|
|
1,144
|
|
1,327
|
|
|
|
|
|
Total
assets
|
|
28,849
|
|
43,063
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Trade
payables
|
|
2,347
|
|
1,688
|
Accrued
expenses
|
|
2,503
|
|
3,378
|
Employee and related
expenses
|
|
1,867
|
|
1,560
|
Operating lease
liabilities
|
|
108
|
|
123
|
|
|
|
|
|
Total current
liabilities
|
|
6,825
|
|
6,749
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
Operating lease
liabilities - long term
|
|
33
|
|
91
|
|
|
|
|
|
Total non-current
liabilities
|
|
33
|
|
91
|
|
|
|
|
|
Commitments and
contingent liabilities
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
6,858
|
|
6,840
|
|
|
|
|
|
Shareholders' equity
(*)
|
|
|
|
|
Ordinary shares no
par value - Authorized: 650,000,000 shares as of June 30, 2023
and
December 31, 2022;
Issued and outstanding:
248,058,700 Ordinary shares as of June 30, 2023 and 232,636,700
as of December 31, 2022;
|
|
|
|
|
|
|
|
|
|
-
|
|
-
|
|
|
|
|
|
-
|
|
-
|
Treasury share at cost
(11,640,460 Ordinary
shares as of June 30, 2023 and
December
31, 2022)
|
|
(1,218)
|
|
(1,218)
|
Additional paid in
capital
|
|
103,751
|
|
101,260
|
Accumulated
deficit
|
|
(80,542)
|
|
(63,819)
|
|
|
|
|
|
Total shareholders'
equity
|
|
21,991
|
|
36,223
|
Total liabilities
and shareholders' equity
|
|
28,849
|
|
43,063
|
(*) 1 American
Depositary Share (ADS) represents 20 Ordinary Shares
|
|
|
|
|
Chemomab Therapeutics
Ltd. and its subsidiaries
|
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Interim Statements of Operations
(Unaudited)
|
In USD thousands
(except for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
Three
months
|
|
Three
months
|
|
Six
months
|
|
Six
months
|
|
|
Ended
|
|
Ended
|
|
Ended
|
|
Ended
|
|
|
June
30,
|
|
June
30,
|
|
June
30,
|
|
June
30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
5,020
|
|
2,914
|
|
11,907
|
|
5,659
|
|
|
|
|
|
|
|
|
|
General and
administrative
|
|
3,175
|
|
3,340
|
|
5,337
|
|
5,915
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
8,195
|
|
6,254
|
|
17,244
|
|
11,574
|
|
|
|
|
|
|
|
|
|
Financing expense
(income), net
|
|
(259)
|
|
480
|
|
(576)
|
|
264
|
|
|
|
|
|
|
|
|
|
Loss before
taxes
|
|
7,936
|
|
6,734
|
|
16,668
|
|
11,838
|
|
|
|
|
|
|
|
|
|
Taxes on income
(benefit)
|
|
34
|
|
(544)
|
|
55
|
|
(544)
|
|
|
|
|
|
|
|
|
|
Net loss for the
period
|
|
7,970
|
|
6,190
|
|
16,723
|
|
11,294
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per Ordinary Share (*)
|
|
0.036
|
|
0.027
|
|
0.076
|
|
0.050
|
|
|
|
|
|
|
|
|
|
Weighted average number
of Ordinary
Shares outstanding, basic, and diluted (*)
|
|
221,674,130
|
|
228,173,276
|
|
221,338,951
|
|
228,132,249
|
|
|
|
|
|
|
|
|
|
(*) 1 American
Depositary Share (ADS) represents 20 Ordinary Shares
|
|
|
|
|
|
|
|
|
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SOURCE Chemomab Therapeutics, Ltd.