─Chemomab to Host Conference Call for Investors
Today, November 11 at 8:00 am ET─
TEL
AVIV, Israel, Nov. 11,
2022 /PRNewswire/ -- Chemomab Therapeutics, Ltd.
(Nasdaq: CMMB), a clinical-stage biotechnology company focused on
the discovery and development of innovative therapeutics for
fibrotic and inflammatory diseases with high unmet need, today
announced financial and operating results for the third quarter
ended September 30, 2022 and provided
a corporate update.

"We continued to make good progress in advancing our clinical
programs for CM-101 during the third quarter," said Dale Pfost, PhD, Chief Executive Officer of
Chemomab. "We have been preparing to report the results of our
liver fibrosis biomarker trial in NASH patients in the coming
weeks, while continuing to implement the expansion of our Phase 2
trial in primary sclerosing cholangitis, or PSC. Activities
included opening additional clinical sites in the U.S. and
Europe and filing regulatory
submissions for the dose-finding cohorts and open label extension
we are adding. We also are ramping up recruitment activities with
patients and physicians to ensure enrollment is on-track.
Importantly, during the quarter we wrapped up the design process
for our upcoming Phase 2 trial in systemic sclerosis, or SSc. We
are very pleased with the design, which was developed with input
from a number of systemic sclerosis experts. In this trial we seek
to confirm the critical role of CCL24 in SSc, and to generate data
that can establish biological and clinical proof of concept for
CM-101. The study should also enable us to identify the optimal
patient population for CM-101 and to inform the selection of
appropriate endpoints for subsequent trials. We anticipate
launching the new trial around year-end and enrolling the first
patients early in 2023."
Dr. Pfost continued, "In support of our ongoing efforts to
educate the scientific and medical communities about the critical
role of CCL24 and CM-101 in fibro-inflammatory diseases, our
researchers made presentations at important scientific meetings
during the quarter. A poster at the recent AASLD Liver Meeting
presented new preclinical data supporting the key role of CCL24 in
the pathophysiology of PSC and showing how CM-101 can interfere
with these disease processes. A featured presentation at the
Anti-Fibrosis Drug Development Summit highlighted how Chemomab has
used biomarkers as a strategic translational tool to inform and
de-risk our drug development programs. A third presentation at an
international conference on lung health unveiled new clinical data
from an investigator-initiated open label study assessing CM-101 in
COVID patients with acute lung injury. It showed that CM-101
administration was well tolerated and was associated with decreases
in inflammatory and fibrogenic biomarkers that are also relevant in
other fibro-inflammatory diseases like systemic sclerosis. This is
an excellent example of the types of data we also hope to see in
the liver fibrosis biomarker study that we are looking forward to
reporting later this year."
Clinical Update
Phase 2 Liver Fibrosis Trial in NASH
patients
Chemomab has concluded the treatment phase of
its randomized, placebo-controlled Phase 2 liver fibrosis trial in
NASH patients. Preparations for a planned topline read-out
continued in the third quarter. The main study outcome is safety
and tolerability, with secondary outcomes including a variety of
biomarkers associated with inflammation and fibrosis. These may
provide useful insights in support of the overall CM-101 clinical
development program and should also generate the pharmacokinetic
and tolerability data needed to inform next steps in the
development of the current subcutaneous formulation of CM-101. The
company is on-track to report study results before year-end.
Phase 2 Trial in Primary Sclerosing Cholangitis
patients
The company has been adding additional
clinical sites, along with an open label extension and a dose
finding component intended to inform selection of the optimal dose
of CM-101 to advance in later development. Global regulatory
filings supporting these changes are proceeding, with a number of
new sites in Europe and the U.S.
now open. An interim Drug Monitoring Committee safety review of the
current PSC cohort is targeted for later this year. Additionally, a
number of outreach and education initiatives have been implemented
to support ongoing patient recruitment.
Phase 2 Trial in Systemic Sclerosis
patients
Chemomab has completed the design of its
upcoming Phase 2 trial in systemic sclerosis. The company aims to
establish biological proof of concept for clinically relevant
aspects of this complex disease, focusing on CM-101's potential
activity in modifying the skin, lung and vascular pathophysiology
observed in SSc patients. To that end, we will enrich the study
with SSc patients who have higher levels of CCL24 and may therefore
be more likely to respond to neutralization of this critical
chemokine.
Key design elements include the following:
- The trial is a randomized, double-blind, placebo-controlled
study that will enroll sixty (60) SSc patients.
- To be eligible for the study, patients must manifest two key
characteristics: the presence of clinically active disease, either
dermatologic or pulmonary, and high serum levels of circulating
CCL24.
- Forty (40) patients will be randomized to treatment with CM-101
and twenty (20) will be randomized to placebo.
- Of the 40 patients on active treatment, approximately half will
have limited SSc, and half will have diffuse cutaneous
disease.
- The study includes a 24-week double blind period during which
patients assigned to active treatment will receive CM-101 at a dose
of 10 mg/kg, via intravenous infusion, every three weeks.
- Following the double-blind period, patients will enter a
24-week open label treatment period, where all patients will
receive CM-101 at a dose of 20 mg/kg via intravenous infusion every
three weeks.
- All patients enrolled will undergo a skin biopsy at baseline
and again after the double-blind treatment period, along with
multiple clinical assessments of skin, vascular and pulmonary
function.
- The primary outcome measure for the trial will be demonstration
of the safety and tolerability of treatment with CM-101.
- All other outcome measures will be principally assessed as
changes from baseline to the end of the double-blind treatment
period.
The secondary outcome measures of the trial are focused on
highly relevant and informative biological read-outs. Key secondary
outcomes include:
- Evaluation of multiple serum-based biological markers that are
known to be associated with different manifestations of SSc
including:
-
- Inflammatory cytokines (such a CCL2, IL6 and CXCL10)
- Vascular and growth factor-related biomarkers (such as VEGF and
PDGF)
- Pulmonary-related biomarkers (such as KL-6, SPD and CCL18),
and
- Fibrogenesis and extracellular matrix biomarkers (collagens,
MMPs and ELF score).
- Inflammatory, fibrotic and target expression markers in skin
biopsies, including but not limited to CCL24 and CCR3 expression
levels.
- Pharmacokinetics and target engagement of CM-101.
- Monitoring for the presence of any potential anti-drug
antibodies during the study.
Exploratory biological outcomes assessments will include
immune cell phenotyping, assessments of neutrophil function, and
ex-vivo biological assays.
Exploratory clinical outcomes will include evaluation
of:
- Vascular involvement, using nail fold capillaroscopy, vascular
imaging and digital ulcer burden
- Skin involvement using modified Rodnan scoring
- Pulmonary disease involvement using pulmonary function tests,
and
- Multiple patient-reported outcome measures.
The data collected should also enable us to evaluate global
effects of intervention with CM-101 using the revised CRISS
scale.
We intend to conduct this study at multiple sites in the U.S.,
the E.U. and Israel. We are
currently finalizing the required regulatory documents and we
intend to file an Investigational New Drug application with the
U.S. Food and Drug Administration in the coming weeks.
Recent Highlights
- At the American Association for the Study of Liver Disease
(AASLD) Liver Meeting® 2022, Chemomab presented a
poster, CCL24 Blockade Attenuates Biliary Inflammation by
Interfering with Monocyte and Neutrophil Recruitment, that
reinforces the key role of CCL24 in the pathophysiology of primary
sclerosing cholangitis. Using two in-vivo models for immune cell
trafficking, Chemomab researchers demonstrated that CCL24 plays a
critical role in the recruitment and migration of monocytes and
neutrophils, which are major players in PSC pathophysiology.
Chemomab's CM-101, a first-in-class CCL24 neutralizing monoclonal
antibody, demonstrated an anti-inflammatory effect by interfering
with migration of these cells to the damaged biliary area in an
animal model of PSC. This study adds to the growing body of
evidence validating CCL24 as a target for PSC and confirming the
therapeutic potential of Chemomab's CCL24-neutralizing
antibody.
- At the Union World Conference on Lung Health 2022,
Chemomab CSO Adi Mor presented Treatment with CM-101 Reduced
Inflammatory & Fibrotic Biomarkers in Patients with
COVID-19-Derived Lung Damage, unveiling promising clinical data
from an investigator-initiated open label clinical study showing
that a single 10 mg/kg dose of CM-101 reduced biomarkers of lung
inflammation and fibrogenesis in hospitalized COVID patients with
serious lung involvement. Some of the mechanisms underlying lung
inflammation resulting from COVID-19 infection are similar to those
seen in chronic diseases that involve lung inflammation and
fibrosis. The objective of the study was to assess the safety and
activity of CM-101, including its impact on biomarkers related to
lung inflammation and systemic sclerosis. CM-101 was well tolerated
and demonstrated activity on these key biomarkers of inflammation
and fibrogenesis that are relevant for systemic sclerosis and other
fibro-inflammatory diseases.
- At the Sixth Anti-Fibrotic Drug Development Summit in
Boston, Dr. Mor was a featured
speaker, highlighting the growing use of inflammatory and fibrotic
biomarkers to inform clinical trial design and de-risk drug
development. In her presentation, Crossing the Divide:
Leveraging Fibrosis-Inflammatory Biomarkers to Inform Clinical
Trial Design, Dr. Mor showed how Chemomab has strategically
used biomarkers throughout the drug discovery and development
process as a key translational tool for competitive advantage, and
how the company is continuing to use them today.
Third Quarter 2022 Financial Highlights
- Cash Position: Cash and cash equivalents were
$46.5 million as of September 30, 2022, compared to $51.8 million as of June
30, 2022. The Company currently expects its runway to last
through year-end 2023.
- Research and Development (R&D) Expenses: R&D
expenses were $5.4 million for the
third quarter ended September 30,
2022, compared to $1.5 million
for the same quarter in 2021. The increase in R&D expense
year-over-year primarily reflects the increase in activities in
support of the company's preclinical and clinical programs.
- General and Administrative (G&A) Expenses: G&A
expenses were $2.9 million for the
third quarter ended September 30,
2022, compared to $1.4 million
for the same quarter in 2021. The increase was primarily due to
increases in salaries and related benefits expenses mainly related
to key additions to the senior management team, as well as an
increase in non-cash share-based expenses.
- Net Loss: Net loss was $8.1
million, or a net loss of approximately $0.035 per basic and diluted share, for the third
quarter ended September 30, 2022,
compared to $3.0 million, or a net
loss of approximately $0.013 per
basic and diluted share, for the quarter ended September 30, 2021.
The weighted average number of ordinary shares outstanding,
basic and diluted were 228,773,418 (equal to 11,438,671
American Depository Shares) and 228,349,115 (equal to
11,417,456 American Depository Shares) for the quarters ended
September 30, 2022, and September 30, 2021, respectively.
For further details on Chemomab's financial results for the
quarter ended September 30, 2022,
refer to the Form 10-Q, which was filed with the SEC on
November 10, 2022.
Conference Call
Chemomab management will host a
conference call for investors today, Friday, November 11, 2022, beginning at 8:00
a.m. Eastern Time to discuss these results and answer
questions. Shareholders and other interested parties may
access the live webcast or replay at Webcast link or at Chemomab's
website at https://investors.chemomab.com/events, or by dialing +1
877-407-9208 (in the U.S.) or +1 201-493-6784 (outside the U.S. and
in Israel) and entering passcode
13732524. Upon dialing in, please request the Chemomab conference
call.
A replay of the call will be available on Chemomab's website for
90 days at www.chemomab.com.
About Chemomab Therapeutics Ltd.
Chemomab is a
clinical stage biotechnology company focusing on the discovery and
development of innovative therapeutics for fibrotic and
inflammatory diseases with high unmet need. Based on the unique and
pivotal role of the soluble protein CCL24 in promoting fibrosis and
inflammation, Chemomab developed CM-101, a monoclonal antibody
designed to bind and block CCL24 activity. CM-101 has demonstrated
the potential to treat multiple severe and life-threatening
fibrotic and inflammatory diseases. It is currently in Phase 2
trials for primary sclerosing cholangitis and liver fibrosis, with
a Phase 2 trial in systemic sclerosis expected to open around
year-end, with first patients enrolled in early 2023. 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: the uncertain
and time-consuming regulatory approval process; risks related to
Chemomab's ability to correctly manage its operating expenses and
its expenses; Chemomab's plans to develop and commercialize its
product candidates, focusing on CM-101; the timing of initiation of
Chemomab's planned clinical trials; the timing of the availability
of data from Chemomab's clinical trials; the timing of any planned
investigational new drug application or new drug application;
Chemomab's plans to research, develop and commercialize its current
and future product candidates; the clinical utility, potential
benefits and market acceptance of Chemomab's product candidates;
Chemomab's commercialization, marketing and manufacturing
capabilities and strategy; Chemomab's ability to protect its
intellectual property position; and the requirement for additional
capital to continue to advance these product candidates, which may
not be available on favorable terms or at all. Additional risks and
uncertainties relating to Chemomab's and its business can be 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.
Contacts:
Media:
Chemomab Therapeutics:
Barbara Lindheim
Consulting Vice President
Investor & Public Relations,
Strategic Communications
Phone: +1 917-355-9234
barbara@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 share amounts)
|
|
|
|
September
30,
|
|
December
31,
|
|
|
2022
|
|
2021
|
Assets
|
|
Unaudited
|
|
Audited
|
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash and cash
equivalents
|
|
10,741
|
|
15,186
|
Short term bank
deposits
|
|
35,725
|
|
45,975
|
Other receivables and
prepaid expenses
|
|
2,259
|
|
1,527
|
|
|
|
|
|
Total current
assets
|
|
48,725
|
|
62,688
|
|
|
|
|
|
Non-current
assets
|
|
|
|
|
Long term prepaid
expenses
|
|
776
|
|
908
|
Property and equipment,
net
|
|
380
|
|
357
|
Restricted
cash
|
|
77
|
|
55
|
Operating lease
right-of-use assets
|
|
261
|
|
345
|
Total non-current
assets
|
|
1,494
|
|
1,665
|
|
|
|
|
|
Total
assets
|
|
50,219
|
|
64,353
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Trade
payables
|
|
1,247
|
|
1,336
|
Accrued
expenses
|
|
2,577
|
|
555
|
Employee and related
expenses
|
|
1,527
|
|
653
|
Operating lease
liabilities
|
|
126
|
|
106
|
|
|
|
|
|
Total current
liabilities
|
|
5,477
|
|
2,650
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
Operating lease
liabilities - long term
|
|
118
|
|
237
|
|
|
|
|
|
Total non-current
liabilities
|
|
118
|
|
237
|
|
|
|
|
|
Commitments and
contingent liabilities
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
5,595
|
|
2,887
|
|
|
|
|
|
Shareholders'
equity
|
|
|
|
|
Ordinary shares no par
value - Authorized: 650,000,000 shares as of September
30, 2022 and as of December 31,
2021;
Issued and outstanding:
229,015,402 ordinary shares as of September 30, 2022 and
228,090,300 as of December 31, 2021 (*)
|
|
|
|
|
|
|
|
|
|
-
|
|
-
|
|
|
|
|
|
-
|
|
-
|
Additional paid in
capital
|
|
100,171
|
|
97,639
|
Accumulated
deficit
|
|
(55,547)
|
|
(36,173)
|
|
|
|
|
|
Total shareholders'
equity
|
|
44,624
|
|
61,466
|
Total liabilities
and shareholders' equity
|
|
50,219
|
|
64,353
|
|
(*) 20 Ordinary Shares
are equal to 1 American Depositary Share (ADS).
|
Condensed
Consolidated Interim Statements of Operations
(Unaudited)
|
In USD thousands
(except share amounts)
|
|
|
|
Three
months
|
|
Three
months
|
|
Nine
months
|
|
Nine
months
|
|
|
Ended
|
|
Ended
|
|
Ended
|
|
Ended
|
|
|
September
30,
|
|
September
30,
|
|
September
30,
|
|
September
30,
|
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
5,423
|
|
1,487
|
|
11,082
|
|
3,951
|
|
|
|
|
|
|
|
|
|
General and
administrative
|
|
2,894
|
|
1,404
|
|
8,809
|
|
3,392
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
8,317
|
|
2,891
|
|
19,891
|
|
7,343
|
|
|
|
|
|
|
|
|
|
Financing expense
(income), net
|
|
(237)
|
|
77
|
|
27
|
|
99
|
|
|
|
|
|
|
|
|
|
Loss before
taxes
|
|
8,080
|
|
2,968
|
|
19,918
|
|
7,442
|
|
|
|
|
|
|
|
|
|
Taxes on income
(benefit)
|
|
-
|
|
-
|
|
(544)
|
|
-
|
|
|
|
|
|
|
|
|
|
Net loss for the
period
|
|
8,080
|
|
2,968
|
|
19,374
|
|
7,442
|
Basic and diluted loss
per Ordinary Share (*) (**)
|
|
0.035
|
|
0.013
|
|
0.085
|
|
0.03
|
Weighted average number
of Ordinary Shares outstanding, basic, and diluted (*)
(**)
|
|
228,773,418
|
|
227,956,060
|
|
228,349,115
|
|
195,292,384
|
|
(*) Number of shares
has been retroactively adjusted to reflect the share reverse split
effected on March 16, 2021 (refer to Note 1B).
|
(**) 20 Ordinary Shares
are equal to 1 American Depositary Share (ADS).
|
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SOURCE Chemomab Therapeutics, Ltd.