TEL AVIV, Israel, March 9, 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
fourth quarter and year ended December 31,
2021, and provided a corporate update.
2021 Highlights:
- In February, announced positive results from a Phase
1b trial in patients with
non-alcoholic fatty liver disease. CM-101 appeared safe and well
tolerated upon multiple administrations, with evidence for dose
dependent target engagement and positive changes in fibrotic
biomarkers.
- In March, completed a merger transaction, listed the company's
ADS's on Nasdaq and closed a $45.5M
PIPE financing.
- In April, dosed the first patient in a CM-101 Phase 2 liver
fibrosis biomarker and subcutaneous formulation study.
- In June, expanded partnership with AGC Biologics for final
optimization and production of GMP manufacturing batches of
CM-101.
- In September, Dale Pfost, PhD,
joined the company as chief executive officer. Chemomab co-founder,
former CEO and chief scientific officer Adi
Mor, PhD, continues as CSO and a director.
- In September, announced a collaboration with researchers at
Leeds University to further elucidate the role of CM-101's target,
CCL24, in the vascular damage associated with systemic sclerosis
(SSc).
- In November, announced that experienced biotechnology executive
Donald Marvin joined as chief
financial officer, executive vice president and chief operating
officer.
- In December, received approval from the FDA for first U.S.
Investigational New Drug application aimed at expanding clinical
activities in Phase 2 trial in primary sclerosing cholangitis.
- In December, biotechnology executive and medical and clinical
trial expert David Weiner, MD,
joined as interim chief medical officer.
In January 2022, the company
announced the addition of Jack
Lawler, who brings extensive experience managing global
clinical trials, as vice president of global clinical development
operations. In February 2022, in a
planned move approved by the company's shareholders, CEO
Dale Pfost assumed the additional
role of Chairman.
Revisions to Chemomab Clinical Programs
Chemomab also announced today that following a comprehensive
strategic review it is making revisions to its current clinical
programs. The changes are designed to optimize the clinical
development of lead product candidate CM-101 by maximizing the
clinical information obtained, generating additional important data
to support future advancement to registration trials, and
decreasing the overall risk in the CM-101 clinical development
program in the lead indications of PSC and SSc, as well as
potentially in additional indications where the scientific
rationale is strong. The key top-line changes to the clinical
development programs include the following:
Expanding the company's commitment to primary sclerosing
cholangitis with an enlarged clinical trial that adds an important
dose finding component. The company plans to implement a dose
finding component to the CM-101 development program by
significantly expanding its Phase 2 trial for PSC. The company will
be increasing the size of the study by adding additional dose
cohorts, including plans to evaluate both a lower and a higher dose
level of CM-101 to support future potential registrational trials.
In addition, the company plans to add an open-label extension to
the trial to evaluate the safety, tolerability and durability of
effect over longer treatment durations. Chemomab plans to perform
an interim analysis of the currently enrolling dose cohort in the
study to assess safety and biomarker data, with an expected
read-out in the second half of this year.
Focusing Chemomab's clinical efforts in systemic sclerosis on
establishing earlier biological and clinical proof of concept.
Chemomab plans to focus its SSc trial towards establishing
biological and clinical proof of concept in this patient
population. The company is revising the design of its planned SSc
trial in a way that should enable an expedited path to proof of
concept data, as well as further elucidation of the different
mechanisms of action of CM-101 in treating the skin, lung and
vascular damage seen in SSc patients. The company is currently
working with key systemic sclerosis researchers and clinical
experts to refine and finalize the design and study endpoints of
the Phase 2 trial and anticipates that these activities will result
in trial initiation in the second half of 2022.
Winding down enrollment in the company's safety,
pharmacokinetic and biomarker liver fibrosis study, yielding a data
readout targeted near the end of 2022. The company will be
winding down its ongoing safety, tolerability and biomarker trial
that is evaluating the subcutaneous formulation of CM-101 in liver
fibrosis patients. Chemomab believes the early completion of this
study should be sufficient to achieve its key objectives—exploring
safety and providing the pharmacokinetic data needed to assess next
steps in the development of the subcutaneous formulation—while
allowing the company to focus its resources on its lead indications
of PSC and SSc. The company will be halting screening and
enrollment in the coming weeks and anticipates results near the end
of 2022. The data readouts in this study will include safety and
tolerability data to support future development of, and deeper
insights into CM-101's mechanism of action and are expected to
provide additional data on the anti-inflammatory and antifibrotic
activity of CM-101 in liver disease.
The company expects that the proposed changes to the CM-101
development program will provide important data on the clinical
dose response relationship to inform the broader development
program and to identify the optimal dose to advance in later PSC
trials. The modifications are also expected to generate proof of
concept data on clinically relevant aspects of SSc, a complex
rheumatological disorder, to best inform the development path for a
novel, first-in-class therapeutic like CM-101, along with relevant
safety and tolerability data to support the evaluation of higher
doses and inform decisions on next steps in the development of the
subcutaneous formulation.
Chemomab intends to provide more detailed information on these
clinical program changes around the time of its first quarter 2022
conference call in May.
"2021 was a transformational year for Chemomab as we became a
public company, launched two Phase 2 trials and expanded our
management team to include highly experienced biotech executives
from the U.S.," said Dale Pfost,
PhD, CEO of Chemomab. "With this foundation in place, we
conducted a comprehensive review of our clinical programs, which
recommended significant changes designed to achieve biological and
pharmacological validation for CM-101 sooner and to prepare us to
advance to registrational trials in as capital and time-efficient a
manner as possible. Overall, we believe that these changes
will sharpen our focus on our clinical efforts in PSC and SSC, and
accelerate the timelines, particularly in SSc, to achieve
meaningful mechanistic, biological and clinical proof of concept
data. These revisions are expected to provide more clinical
data read-outs over the next 24 months—we anticipate 3-4 data
readouts compared to the two previously planned. They are also
expected to decrease our capital requirements and enable us to
extend our cash runway by about six months through to the end of
2023. We are excited about moving forward with this revised
clinical program and look forward to providing more detail on our
plans in the next few months."
Fourth Quarter and Full-Year 2021 Financial
Highlights
- Cash Position: Cash, cash equivalents and short-term
bank deposits were $61.2 million as
of December 31, 2021, compared to
$11.8 million as of December 31, 2020.
- Research and Development (R&D) Expenses: R&D
expenses were $2.4 million for the
quarter and $6.3 million for the full
year ended December 31, 2021,
compared to $1.3 million and
$4.7 million for the same quarter and
year in 2020.
- General and Administrative (G&A) Expenses: G&A
expenses were $2.6 million for the
quarter and $6.0 million for the full
year ended December 31, 2021,
compared to $0.7 million and
$1.3 million for the same quarter and
year in 2020.
- Net Loss: Net loss was $5.0
million, or a net loss of $0.02 per basic and diluted Ordinary Share, for
the fourth quarter and $12.5 million,
or a net loss of $0.06 per basic and
diluted Ordinary Share for the year ended December 31, 2021, compared to $2.0 million, or a net loss of $0.01 per basic and diluted share, for the
quarter and $6.0 million, or a net
loss of $0.04 per basic and diluted
Ordinary Share, for the full year ended December 31, 2020. The weighted average number of
Ordinary Shares outstanding, basic and diluted were 207,468,650 and
136,755,498 for the year ended December 31,
2021, and December 31, 2020,
respectively.
For further details on the company's financial results for the
year ended December 31, 2021, please
refer to the company's Annual Report on Form 10-K, which will be
filed with the SEC before the end of March
2022.
Conference Call
Chemomab management will host a
conference call for investors today, Wednesday, March 9, 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 13727097. The
live webcast will also be available on the company's website at
https://investors.chemomab.com/events.
A replay of the call will be available for 90 days at
www.chemomab.com.
About Chemomab Therapeutics
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 two Phase 2
safety and efficacy trials—one in patients with primary sclerosing
cholangitis and the second in patients with liver fibrosis, with a
third Phase 2 trial in systemic sclerosis expected to begin in
2022. For more information on Chemomab,
visit www.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,
including Chemomab's new Chief Executive Officer; 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:
Irina Koffler
LifeSci Advisors, LLC
Phone: +1-917-734-7387
ir@chemomab.com
Chemomab Therapeutics:
Barbara Lindheim
Consulting Vice
President
Investor & Public Relations,
Strategic Communications
Phone: +1-917-355-9234
barbara@chemomab.com
Consolidated
Balance Sheets as of
|
In USD thousands
(except share and per share amounts)
|
|
|
|
December
31,
|
December
31,
|
|
|
2021
|
2020
|
Assets
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
|
14,686
|
11,674
|
Short-term bank
deposit
|
|
46,475
|
24
|
Other receivables and
prepaid expenses
|
|
1,527
|
141
|
|
|
|
|
Total current
assets
|
|
62,688
|
11,839
|
|
|
|
|
Non-current
assets
|
|
|
|
Long-term
deposits
|
|
-
|
4
|
Long-term prepaid
expenses
|
|
908
|
-
|
Restricted
cash
|
|
55
|
53
|
Property and
equipment, net
|
|
357
|
152
|
Operating lease
right-of-use assets
|
|
345
|
428
|
|
|
|
|
Total non-current
assets
|
|
1,665
|
637
|
|
|
|
|
Total
assets
|
|
64,353
|
12,476
|
|
|
|
|
Current
liabilities
|
|
|
|
Trade
payables
|
|
1,336
|
93
|
Accrued
expenses
|
|
555
|
715
|
Employee and related
expenses
|
|
653
|
438
|
Operating lease
liabilities
|
|
106
|
70
|
|
|
|
|
Total current
liabilities
|
|
2,650
|
1,316
|
Non-current
liabilities
|
|
|
|
Non-current operating lease
liabilities
|
|
237
|
358
|
Total non-current
liabilities
|
|
237
|
358
|
|
|
|
|
Commitments and
contingent liabilities
|
|
|
|
|
|
|
|
Total
liabilities
|
|
2,887
|
1,674
|
|
|
|
|
Shareholders'
equity
|
|
|
|
Ordinary shares no
par value - Authorized: 650,000,000 shares as of
December 31, 2021 and 500,000,000 shares as of December 31,
2020;
|
|
|
|
Issued and
outstanding: 228,090,300 ordinary shares at December 31,
2021 and 9,274,838 ordinary shares at December 31, 2020
|
|
|
|
|
|
-
|
-
|
Additional paid-in
capital
|
|
97,639
|
34,497
|
Accumulated
deficit
|
|
(36,173)
|
(23,695)
|
|
|
|
|
Total
shareholders' equity
|
|
61,466
|
10,802
|
|
|
|
|
Total liabilities
and shareholders' equity
|
|
64,353
|
12,476
|
|
|
|
|
|
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,
|
|
2021
|
2020
|
2021
|
2020
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
Research and
development
|
2,383
|
1,254
|
6,334
|
4,684
|
|
|
|
|
|
General and
administrative
|
2,641
|
688
|
6,033
|
1,288
|
|
|
|
|
|
Total operating
expenses
|
5,024
|
1,942
|
12,367
|
5,972
|
|
|
|
|
|
Financing income,
net
|
12
|
9
|
111
|
(21)
|
|
|
|
|
|
Net loss for the
period
|
5,036
|
1,951
|
12,478
|
5,951
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per Ordinary Share*
|
0.022
|
0.014
|
0.060
|
0.044
|
|
|
|
|
|
Weighted average
number of Ordinary
Shares outstanding, basic, and diluted*
|
228,018,874
|
143,861,509
|
207,468,650
|
136,755,498
|
|
*Number of shares has
been retroactively adjusted to reflect the share reverse split
effected on March 16,
2021
|
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SOURCE Chemomab Therapeutics, Ltd.