─Reported Top-line Results from CM-101 Phase 2
Liver Fibrosis Trial in NASH Patients Demonstrating Safety and
Positive Activity Across Multiple Fibrotic and Inflammatory
Biomarkers─
─Received FDA Clearance for CM-101 Systemic
Sclerosis IND—Phase 2 Trial Expected to Open Mid-year─
─Advancing Phase 2 PSC Trial and Enrolling
Patients in Higher Dose Cohort ─
─Extending Estimated Cash Runway Through First
Half of 2024─
─Company to Host Conference Call for
Investors Today, May 11 at
8:00 am ET ─
TEL
AVIV, Israel, May 11, 2023
/PRNewswire/ -- Chemomab Therapeutics, Ltd. (Nasdaq: CMMB),
(Chemomab), 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 first quarter ended
March 31, 2023, and provided a
corporate update.
"I am pleased to report that we have continued to make good
progress on multiple fronts since our last quarterly update," said
Dale Pfost, PhD, Chief Executive
Officer of Chemomab. "In January we reported encouraging top-line
results from our CM-101 Phase 2 liver fibrosis trial in
nonalcoholic steatohepatitis (NASH) patients. In this study CM-101
appeared safe and demonstrated improvement across multiple
disease-related fibrotic and inflammatory biomarkers. In our view,
these data have been generally well-received by opinion leaders and
potential partners. Importantly, these results also are consistent
with the encouraging biomarker changes that were observed in two
earlier CM-101 clinical trials and reinforce our optimism about
CM-101's potential as a treatment for fibro-inflammatory
diseases."
Dr. Pfost continued, "We continue to make good progress in
advancing our CM-101 Phase 2 clinical program in primary sclerosing
cholangitis (PSC). We have opened additional clinical sites, added
an open label extension and enhanced our patient outreach
activities, supporting our goal of reporting top-line data in the
second half of next year."
"Turning to systemic sclerosis (SSc), earlier this year we
reported that our Investigational New Drug (IND) submission for our
CM-101 Phase 2 trial was cleared by the FDA. We have been working
diligently to prepare for the start of this proof-of-concept trial
and we are on track to open our initial U.S. sites around mid-year.
We expect to report data from this trial in the latter part of
2024. We also are supporting our clinical programs with an active
schedule of scientific presentations at major medical meetings in
the U.S. and Europe, and we
anticipate several scientific publications in respected journals
going forward. These activities aim to build knowledge about, and
interest in, our unique approach to fibro-inflammatory diseases
among researchers and opinion leaders."
"Since our last call, we have also added two exceptional senior
executives—our Chief Medical Officer, Dr. Matt Frankel, and our Vice President of
Corporate Development and Strategy, Dr. Mitch Jones. Matt brings us a wealth of global
clinical and medical affairs experience, along with his track
record in helping to bring numerous drugs to market. Mitch is an
MD/PhD with a rich combination of science and business skills that
make him uniquely well qualified to lead the corporate development
function at Chemomab."
"I am also pleased to announce that today we are extending our
estimated cash runway by another quarter through the first half of
2024," said Dr. Pfost. "We accomplished this extension while
maintaining the resources needed to advance our two clinical
programs towards our expected data read-outs in the second half of
2024. In conclusion, we believe that CM-101 has the potential to
make a difference in deadly diseases with few current treatment
options and we are committed to staying laser-focused on assessing
its potential."
Clinical Update
Reported Top-line Results from CM-101 Phase 2 Liver Fibrosis
Trial in NASH Patients
Top-line results were reported in January demonstrating that
CM-101 met its primary endpoint of safety and tolerability and
showed positive activity across multiple liver fibrosis biomarkers
and physiologic assessments. These results provide insights
supporting the overall CM-101 clinical development program as well
as pharmacokinetic and tolerability data needed to inform next
steps in the development of the current subcutaneous formulation of
CM-101.
Advanced Phase 2 Trial in PSC Patients
Late last year, the independent Drug Monitoring Committee for
the PSC trial reviewed CM-101 safety data and cleared the addition
of a planned higher dose arm to the trial. In recent months
Chemomab has opened additional clinical trial sites and implemented
a protocol amendment adding the higher dose cohort and an open
label extension. Currently Chemomab believes it is on track to
report top-line data from the double-blind portion of this trial in
the second half of 2024.
Received FDA IND Clearance for CM-101 Phase 2 Trial in SSc
Patients
Following the recent IND clearance, Chemomab is finalizing plans
to open the Phase 2 SSc trial to patient enrollment by mid-year.
The study will be conducted at multiple sites in the U.S.,
Europe and Israel. It aims to confirm the critical role
of CCL24 in SSc and to establish biological and clinical
proof-of-concept for CM-101 in patients with SSc. The study is
designed to generate additional information about disease
mechanisms and to enable more informed decisions about future
patient stratification strategies and the selection of endpoints
for registrational studies. An initial data read-out is planned for
the second half of 2024.
First Quarter 2023 Financial Highlights
- Cash Position: Cash, cash equivalents and short-term
bank deposits were $32.8 million as
of March 31, 2023, compared to
$39.9 million at December 31, 2022.
- Research and Development (R&D) Expenses: R&D
expenses were $6.9 million for the
quarter ended March 31, 2023,
compared to $2.7 million for the same
quarter in 2022. The increase was primarily due to increased
clinical and preclinical activities.
- General and Administrative (G&A) Expenses: G&A
expenses were $2.2 million for the
quarter ended March 31, 2023,
compared to $2.6 million for the same
quarter in 2022.
- Net Loss: Net loss was $8.8
million, or a net loss of approximately $0.04 per basic and diluted ordinary share for
the first quarter of 2023, compared to $5.1
million, or a net loss of approximately $0.02 per basic and diluted ordinary share for
the quarter ended March 31, 2022. The
weighted average number of ordinary shares outstanding, basic and
diluted, was 220,996,240 (equal to approximately 11 million
ADSs) for the quarter ended March 31,
2023.
For further details on the company's financial results for the
quarter ended March 31, 2023, please
refer to the company's quarterly report on Form 10-Q filed with the
Securities and Exchange Commission today.
Conference Call and Webcast
Chemomab management will host a conference call for
investors today, Thursday, May 11,
2023, beginning at 8:00 a.m. Eastern Time to
discuss these results and answer questions.
Click this Webcast link to access the live webcast or replay.
The live webcast and replay can also be accessed at the News &
Events section of the Investors page on
the Chemomab website
at investors.chemomab.com/events.
To access the conference call via telephone, shareholders and
other interested parties can dial
+1 (877) 407-9208 (in the U.S.) or +1 (201) 493-6784 (outside the
U.S., including Israel) and enter
passcode 3735393. Please call 5-10 minutes before the scheduled
start time, enter the conference passcode and ask the operator for
the Chemomab conference call.
Or click on Call meTM starting 15 minutes before the
scheduled start time for instant telephone access without having to
wait for an operator.
A replay of the call will be available on Chemomab's website for
90 days at www.chemomab.com.
About Chemomab Therapeutics
Chemomab is a clinical stage biotechnology company discovering
and developing innovative therapeutics for fibro-inflammatory
diseases with high unmet need. Based on the unique and pivotal role
of the chemokine CCL24 in promoting fibrosis and inflammation,
Chemomab developed CM-101, a monoclonal antibody designed to
neutralize CCL24 activity. In preclinical and clinical studies to
date, CM-101 appears safe, with the potential to treat multiple
severe and life-threatening fibro-inflammatory diseases.
Encouraging results from a Phase 2 biomarker study in NASH patients
and an investigator study in patients with severe lung injury were
recently reported. A Phase 2 trial in primary sclerosing
cholangitis patients is ongoing and a Phase 2 systemic sclerosis
trial is expected to begin around midyear. For more information on
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
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 & Investors:
Chemomab Therapeutics:
Barbara Lindheim
Consulting Vice President
Investor & Public Relations,
Strategic Communications
Phone: +1 917-355-9234
barbara.lindheim@chemomab.com
Investor Relations:
Irina Koffler
LifeSci Advisors, LLC
Phone: +1 917-734-7387
ir@chemomab.com
Condensed
Consolidated Balance Sheets
|
In USD thousands
(except for share amounts)
|
|
|
|
March 31,
|
December 31,
|
|
|
2023
|
2022
|
Assets
|
|
Unaudited
|
Audited
|
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
|
20,765
|
13,519
|
Short term bank
deposits
|
|
11,941
|
26,374
|
Restricted
cash
|
|
77
|
77
|
Other receivables and
prepaid expenses
|
|
995
|
1,766
|
|
|
|
|
Total current
assets
|
|
33,778
|
41,736
|
|
|
|
|
Non-current
assets
|
|
|
|
Long term prepaid
expenses
|
|
690
|
733
|
Property and equipment,
net
|
|
352
|
367
|
Operating lease
right-of-use assets
|
|
193
|
227
|
Total non-current
assets
|
|
1,235
|
1,327
|
|
|
|
|
Total
assets
|
|
35,013
|
43,063
|
|
|
|
|
Current
liabilities
|
|
|
|
Trade
payables
|
|
2,217
|
1,688
|
Accrued
expenses
|
|
3,164
|
3,378
|
Employee and related
expenses
|
|
1,501
|
1,560
|
Operating lease
liabilities
|
|
115
|
123
|
|
|
|
|
Total current
liabilities
|
|
6,997
|
6,749
|
|
|
|
|
Non-current
liabilities
|
|
|
|
Operating lease
liabilities - long term
|
|
62
|
91
|
|
|
|
|
Total non-current
liabilities
|
|
62
|
91
|
|
|
|
|
Commitments and
contingent liabilities
|
|
|
|
|
|
|
|
Total
liabilities
|
|
7,059
|
6,840
|
|
|
|
|
Shareholders'
equity
|
|
|
|
Ordinary shares no par
value - Authorized: 650,000,000 shares as of March 31, 2023
and December 31, 2022;
|
|
-
|
-
|
Issued and outstanding:
232,636,700 Ordinary shares as of March 31, 2023 and December
31, 2022;
|
|
-
|
-
|
Treasury share at cost
(11,640,460 Ordinary
shares as of March 31, 2023 and December
31, 2022)
|
|
(1,218)
|
(1,218)
|
Additional paid in
capital
|
|
101,744
|
101,260
|
Accumulated
deficit
|
|
(72,572)
|
(63,819)
|
|
|
|
|
Total shareholders'
equity
|
|
27,954
|
36,223
|
Total liabilities
and shareholders' equity
|
|
35,013
|
43,063
|
Condensed
Consolidated Interim Statements of Operations
(Unaudited)
|
In USD thousands
(except for share and per share amounts)
|
|
|
|
Three
months
|
Three
months
|
|
|
Ended
|
Ended
|
|
|
March
31,
|
March
31,
|
|
|
2023
|
2022
|
Operating
expenses
|
|
|
|
|
|
|
|
Research and
development
|
|
6,887
|
2,745
|
|
|
|
|
General and
administrative
|
|
2,162
|
2,575
|
|
|
|
|
Total operating
expenses
|
|
9,049
|
5,320
|
|
|
|
|
Financing income,
net
|
|
(317)
|
(216)
|
|
|
|
|
Loss before
taxes
|
|
8,732
|
5,104
|
|
|
|
|
Taxes on
income
|
|
21
|
-
|
|
|
|
|
Net loss for the
year
|
|
8,753
|
5,104
|
|
|
|
|
Basic and diluted loss
per Ordinary Share (*)
|
|
0.04
|
0.02
|
Weighted average number
of Ordinary Shares outstanding, basic, and diluted (*)
|
|
|
228,090,300
|
|
(*) 20 Ordinary Shares
are equal to 1 American Depositary Share (ADS)
|
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SOURCE Chemomab Therapeutics, Ltd.