─Chemomab to Host Webcast and Conference
Call for Investors Today, August 12
at 8:00 am ET─
TEL
AVIV, Israel, Aug. 12,
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 second quarter
ended June 30, 2022 and provided a
corporate update.
"We continued to make good progress on multiple fronts in the
second quarter," said Dale Pfost,
PhD, Chairman and Chief Executive Officer of Chemomab. "We advanced
our clinical programs for CM-101, our first-in-class monoclonal
antibody that neutralizes CCL24, a novel disease target at the
confluence of fibrosis and inflammation; we added to our
intellectual property portfolio for CM-101; we presented important
new data at major scientific meetings; and we added several highly
experienced staff essential to progressing our scientific and
clinical priorities."
Dr. Pfost continued, "Congratulations to our research team for
gaining issuance of a new U.S patent covering the use of CM-101 in
liver diseases such as primary sclerosing cholangitis (PSC),
thereby further extending our proprietary protection for disease
targets involving hepatic and cholestatic conditions. I am also
very pleased at how active our researchers and consultants have
been in the past few months educating their scientific and medical
peers by presenting data on CCL24 and CM-101 at major international
scientific meetings. We recently added several outstanding research
and clinical experts to our team to help ensure rapid advancement
of our preclinical and clinical programs. In addition, we
added a new director, Jill Quigley,
JD, who brings a wealth of biotechnology strategic and operational
expertise to our board. These are exciting times for our company,
and I look forward to reporting more details on our progress in the
coming months."
Clinical Update:
Phase 2 Liver Fibrosis Trial in NASH patients
Chemomab concluded the treatment phase of its randomized,
placebo-controlled Phase 2 liver fibrosis trial that included a
total of 23 NASH patients, with patients in the active arm
receiving 5mg/kg of CM-101 delivered subcutaneously in 8 doses
administered once every two weeks. This sets the stage for a
planned topline study read-out before year-end. Importantly, these
data represent the first read-out of CM-101's activity in patients
with established liver disease. The main study outcome is safety
and tolerability. Additionally, based on the encouraging signs of
activity observed in the CM-101 Phase 1b study in patients with non-alcoholic fatty
liver disease, the company believes that evaluations of similar
secondary outcomes in this patient population with more severe
liver fibrosis and inflammation could be informative, and may
provide useful insights in support of the overall CM-101 clinical
development program. The trial results should also generate the
pharmacokinetic and tolerability data needed to inform next steps
in the development of the subcutaneous formulation of CM-101.
Phase 2 Trial in Primary Sclerosing Cholangitis
patients
Chemomab previously indicated its intention to increase its
efforts in the rare disease primary sclerosing cholangitis, or PSC,
including expanding the size and scope of the ongoing randomized,
placebo-controlled Phase 2 trial. The company is adding an open
label extension and a dose finding component intended to better
inform selection of the optimal dose of CM-101 to advance into late
development. These revisions have been finalized and global
regulatory filings supporting the trial expansion have been
initiated, while new sites in Europe and the U.S. continue to open. The
company plans to enroll a total of 93 patients: 25 patients in each
of the three dosing cohorts, which include the current 10mg/kg dose
along with a lower 5 mg/kg dose and a higher 20mg/kg dose. Another
18 patients are receiving placebo. All outcome measures in the
trial, including evaluations of serum ALP levels, serum biological
markers, and Fibroscan, remain unchanged, except that the primary
outcome now is safety. Consistent with this change, the study is
not formally powered to assess efficacy. However, cohort sizes
sufficient to detect, with expected variability, a clinically
relevant improvement in serum ALP levels (defined as change from
baseline), which is a key secondary outcome for studies in PSC,
have been maintained. A blinded interim Drug Monitoring
Committee safety review of the current cohort is planned for late
this year, and Chemomab anticipates reporting topline data from the
trial in the second half of 2024.
Phase 2 Trial in Systemic Sclerosis patients
Chemomab has made significant progress in delineating the design
of its upcoming Phase 2 trial in systemic sclerosis, or SSc,
working closely with a number of top systemic sclerosis experts.
The company aims to establish biological proof of concept on
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. Plans to launch
the trial by the end of this year remain on track. A special
webcast to provide details on the final trial design is planned in
the next several months.
Recent Highlights:
- Awarded U.S. Patent No.11365246, "Anti CCL24 (eotaxin 2)
Antibodies for Use in the Treatment of Hepatic Disease," a new
method of use patent that covers the use of CM-101 and other
anti-CCL24 antibodies and binding fragments in the treatment of a
range of fibro-inflammatory liver diseases, including primary
sclerosing cholangitis and other cholestatic-related disorders. The
new patent extends Chemomab's intellectual property protection for
CM-101 in the U.S. for another three years through at least 2038,
with additional extensions possible.
- At a poster presentation at the EULAR European Congress of
Rheumatology (June 1-4, Copenhagen, DK), Chemomab collaborator
Professor Francesco Del Galdo of the
University of Leeds presented a
poster further supporting the role of CCL24 as a therapeutic target
for systemic sclerosis. This study, which examined the role of
CCL24 in longitudinal cohorts of diffuse cutaneous SSc patients,
reported elevated serum levels of CCL24 in these patients and
showed that high circulating CCL24 levels were correlated with
disease activity and worse prognosis, as reflected by high fibrotic
activity and deterioration of lung function over time.
- In an oral presentation at the 2022 EASL International Liver
Congress (June 22-26, London, UK), Chemomab researchers presented
data from a preclinical PSC model that used advanced technologies
to reveal unique liver macrophage subpopulations as the major
source of CCL24 production in the area of the bile duct that is
damaged in PSC. Chemomab scientists also demonstrated in this model
that treatment with CM-101 interfered with core PSC disease
pathways in a way that is potentially associated with therapeutic
activity.
- At the first international Extracellular Matrix Pharmacology
Conference (June 23-25, Copenhagen
DK), Chemomab researchers presented a poster that included both
preclinical and early clinical data demonstrating that CM-101
attenuates biomarkers associated with extracellular matrix (ECM)
expression. ECM expression is involved in PSC pathophysiology and
is closely related to CM-101's mechanism of action. Importantly,
this dataset supports the company's efforts to translate findings
on preclinical biomarkers associated with ECM remodeling in the
liver to the use of similar serum biomarkers in patients in its
clinical trials.
- Appointed Jill M. Quigley, JD,
to the Chemomab board of directors. Ms. Quigley brings more than 20
years of biotechnology industry leadership experience encompassing
executive management, corporate operations, legal affairs,
financings, and board membership. Previously Ms. Quigley was Chief
Operating Officer at Passage Bio.
- Appointed Ilan Vaknin, PhD, MBA,
as Vice President of Research & Development. Dr. Vaknin brings
Chemomab more than 20 years of biotechnology drug discovery and
development experience in immunology, translational research,
antibody development and manufacturing, and bioassay development,
including more than a decade in senior science roles at Compugen,
Ltd.
- Appointed Christina Crater, MD,
as Vice President of Clinical Development. Dr. Crater brings
Chemomab an extensive background in medical affairs and clinical
trial design and execution, across a broad range of therapeutic
indications. She has served as medical monitor, safety
physician, therapeutic expert and study director in all phases of
clinical development. Dr. Crater's experience spans pharmaceutical
firms including Bristol-Myers Squibb, as well as major clinical
research organizations including PRA Health Sciences and PAREXEL
International.
- Presented at the JMP Securities Life Sciences and HC Wainwright
Global Investment Conferences. Recorded webcasts from these events
can be accessed at Chemomab's website at
https://investors.chemomab.com/events.
Second Quarter 2022 Financial Highlights
- Cash Position: Cash, cash equivalents and bank deposits
were $51.8 million as of June 30, 2022, compared to $57.5 million at March 31, 2022. The company currently expects its
runway to last through the end of 2023, consistent with the update
provided last quarter.
- Research and Development (R&D) Expenses: R&D
expenses were $2.9 million for the
quarter ended June 30, 2022, compared
to $1.3 million for the same quarter
in 2021. The increase in R&D expense quarter-over-quarter
primarily reflects the ramp-up in activities supporting the
company's clinical programs for CM-101.
- General and Administrative (G&A)
Expenses: G&A expenses were $3.3 million for the quarter ended June 30, 2022, compared to $1.5 million for the same quarter in 2021. The
increase in cash G&A in the second quarter partly reflects key
additions to the senior management team, as well as a non-cash
charge for previously disclosed equity-based compensation plus a
provision accrued for a potential tax liability, the majority of
which arises from transactions that took place prior to the
company's reverse merger in March
2021.
- Net Loss: Net loss was $6.2
million, or a net loss of approximately $0.03 cents per basic and diluted ordinary share,
for the second quarter of 2022, compared to $2.8 million, or a net loss of approximately
$0.01 per basic and diluted ordinary
share, for the quarter ended June 30,
2021. The weighted average number of Ordinary Shares
outstanding, basic and diluted were 228,173,276 (equal to
11,408,664 ADS's) for the quarter ended June 30, 2022.
For further details on Chemomab's financial results for the
quarter ended June 30, 2022, refer to
the Form 10-Q, which will be filed with the SEC today, August 12, 2022.
Live Webcast and Conference Call at 8:00 am Eastern Time, Friday, August 12, 2022
Chemomab management will host a webcast and conference
call today, Friday, August 12,
2022, beginning at 8:00 a.m. Eastern Time to
discuss these results and answer questions. Shareholders and
other interested parties may participate in the conference call by
clicking this Webcast link to access the live webcast or replay, or
by dialing 877-407-9208 (in the U.S.) or 201-493-6784 (outside the
U.S. and in Israel) and entering
passcode 13730646. Please call 5-10 minutes before the scheduled
start time, enter the conference passcode and ask the operator for
the Chemomab conference call. The webcast link is also available on
the company's website at https://investors.chemomab.com/events
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 begin in late 2022. For more information,
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: risks related to Chemomab's ability to effectively
implement the revised clinical strategy and its ability to achieve
the anticipated results; risks related to the projections and
associated benefits in pursuing the contemplated changes to the
clinical strategy; risks associated with the ongoing transitions of
certain of our executive officers; 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 including any potential
delays associated with Chemomab's contemplated revised clinical
strategy; 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, except to the extent required by applicable law.
Contacts:
|
|
Investor
Relations:
|
Media:
|
Irina Koffler
|
Barbara
Lindheim
|
LifeSci Advisors,
LLC
|
Chemomab
Therapeutics
|
Phone: +1 (917)
734-7387
|
Consulting Vice
President
|
ir@chemomab.com
|
Investor & Public
Relations,
|
|
Strategic
Communications
|
|
Phone: +1 (917)
355-9234
|
|
barbara@chemomab.com
|
Condensed
Consolidated Balance Sheets
|
In USD thousands
(except share amounts)
|
|
|
|
June
30,
|
December
31,
|
|
|
2022
|
2021
|
Assets
|
|
Unaudited
|
Audited
|
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
|
9,883
|
15,186
|
Short term bank
deposits
|
|
41,841
|
45,975
|
Other receivables and
prepaid expenses
|
|
3,106
|
1,527
|
|
|
|
|
Total current
assets
|
|
54,830
|
62,688
|
|
|
|
|
Non-current
assets
|
|
|
|
Long term prepaid
expenses
|
|
821
|
908
|
Property and equipment,
net
|
|
355
|
357
|
Restricted
cash
|
|
77
|
55
|
Operating lease
right-of-use assets
|
|
295
|
345
|
Total non-current
assets
|
|
1,548
|
1,665
|
|
|
|
|
Total
assets
|
|
56,378
|
64,353
|
|
|
|
|
Current
liabilities
|
|
|
|
Trade
payables
|
|
1,433
|
1,336
|
Accrued
expenses
|
|
1,712
|
555
|
Employee and related
expenses
|
|
1,117
|
653
|
Operating lease
liabilities
|
|
132
|
106
|
|
|
|
|
Total current
liabilities
|
|
4,394
|
2,650
|
|
|
|
|
Non-current
liabilities
|
|
|
|
Operating lease
liabilities - long term
|
|
148
|
237
|
|
|
|
|
Total non-current
liabilities
|
|
148
|
237
|
|
|
|
|
Commitments and
contingent liabilities
|
|
|
|
|
|
|
|
Total
liabilities
|
|
4,542
|
2,887
|
|
|
|
|
Shareholders'
equity
|
|
|
|
Ordinary shares no par
value - Authorized: 650,000,000 shares as of
June 30, 2022 and as of December
31, 2021
|
|
-
|
-
|
Issued and outstanding:
228,633,120 ordinary shares as of June 30,
2022 and 228,090,300 as of December 31, 2021*
|
|
-
|
-
|
Additional paid in
capital
|
|
99,303
|
97,639
|
Accumulated
deficit
|
|
(47,467)
|
(36,173)
|
|
|
|
|
Total shareholders'
equity
|
|
51,836
|
61,466
|
Total liabilities
and shareholders' equity
|
|
56,378
|
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 and per share amounts)
|
|
|
|
Three
months
|
Three
months
|
Six
months
|
Six
months
|
|
|
|
Ended
|
Ended
|
Ended
|
Ended
|
|
|
|
June
30,
|
June
30,
|
June
30,
|
June
30,
|
|
|
|
2022
|
2021
|
2022
|
2021
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
2,914
|
1,307
|
5,659
|
2,464
|
|
|
|
|
|
|
|
|
General and
administrative
|
|
3,340
|
1,446
|
5,915
|
1,988
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
6,254
|
2,753
|
11,574
|
4,452
|
|
|
|
|
|
|
|
|
Financing expense,
net
|
|
480
|
17
|
264
|
22
|
|
|
|
|
|
|
|
|
Loss before
taxes
|
|
6,734
|
2,770
|
11,838
|
4,474
|
|
|
|
|
|
|
|
|
Taxes on income
(benefit)
|
|
(544)
|
-
|
(544)
|
-
|
|
|
|
|
|
|
|
|
Net loss for the
period
|
|
6,190
|
2,770
|
11,294
|
4,474
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per Ordinary Share (*) (**)
|
|
0.027
|
0.013
|
0.050
|
0.024
|
|
|
|
|
|
|
|
|
Weighted average
number of Ordinary Shares outstanding, basic, and diluted (*)
(**)
|
|
228,173,276
|
216,266,993
|
216,266,993
|
186,840,022
|
|
|
|
|
|
|
|
|
|
|
|
(*) Number of shares
has been retroactively adjusted to reflect the share reverse split
effected on March 16, 2021
|
(**) 20 Ordinary Shares
are equal to 1 American Depositary Share (ADS)
|
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SOURCE Chemomab Therapeutics, Ltd.