—Continued Strong Progress in Advancing
CM-101 Phase 2 PSC Trial Towards Completion of Enrollment--On Track
for Topline Readout in Second Half of 2024—
—Reiterates Guidance that Cash Reserves Are
Sufficient to Fund the Company Through the End of 2024, with
Decreasing Quarterly Cash Burn Expected to Continue—
TEL
AVIV, Israel, Nov. 9, 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 reported
financial and operating results for the third quarter ended
September 30, 2023, and provided a
corporate update.
"Chemomab made excellent progress during the third quarter,"
said Adi Mor, PhD, co-founder, Chief
Executive Officer and Chief Scientific Officer of Chemomab. "Our
focus on successfully completing our CM-101 Phase 2 trial in
primary sclerosing cholangitis (PSC) is fueling rapid progress, as
robust patient interest is enabling us to advance towards
completion of the enrollment stage of the trial. We expect to
provide more detail on projected trial completion and reporting
timelines early in the new year."
Dr. Mor added, "During the quarter we also participated in
activities to raise awareness about PSC and the high unmet need for
effective PSC therapies. We were an active participant in and
supporter of the annual conference of the leading U.S. patient
advocacy organization, which was complemented by our work with PSC
advocates in Europe and
Israel. We also continued to work
closely with PSC key opinion leaders who are coordinating efforts
to advance the evolving regulatory environment for PSC therapies,
with the goal of incorporating new knowledge and improved
technologies into regulatory decision-making. We expect that our
ongoing collaborations with opinion leaders and patient groups will
help us move expeditiously towards a Phase 3 registrational trial
in PSC, if our current Phase 2 trial is successful."
"We are also continuing our campaign to educate the scientific
and medical communities about CCL24 and CM-101. We have an oral
presentation and multiple posters at both the 2023 AASLD Liver
Meeting® in Boston and
the 2023 ACR Convergence conference in San Diego next week. Our continued success in
achieving oral and poster presentations at top medical conferences
highlights the scientific relevance of our CM-101 programs."
"We are continuing to manage our resources prudently and expect
our quarterly cash burn to continue to decrease in 2024. We
reiterate our prior guidance that we believe we have adequate
financial resources to both achieve our significant Phase 2 PSC
topline data milestone and take us through the end of next year. We
view the upcoming PSC milestone as a major catalyst for Chemomab.
If successful, we expect the trial results to provide us a range of
options for advancing CM-101 in PSC and other indications."
"Finally, I want to note that despite the major challenges
confronting Israel, we do not
expect an impact on our ongoing activities. Currently, our
headquarters and R&D operations in Tel Aviv are fully operational and our
clinical development and medical affairs teams based in the U.S.
are functioning normally, as planned. We would like to thank our
employees and our many colleagues around the globe who have offered
us tremendous support during this difficult time for Israel."
Third Quarter 2023 Corporate Updates
Scientific Studies Accepted for Oral and Poster Presentations
at 2023 AASLD The Liver Meeting® and at ACR Convergence
2023
Studies authored and co-authored by Chemomab scientists
were accepted for presentation at two major U.S. medical
conferences in November, including an oral presentation on PSC and
a scientific poster at the AASLD The Liver Meeting® in
Boston, as well as a poster
presentation on the role of Chemomab's CCL24 target in systemic
sclerosis at the American College of Rheumatology Convergence 2023
conference in San Diego. Further
details of the presentations will be released later this month.
Participated in Investor Conferences
Chemomab
management recently participated in several investor conferences,
including the 2023 Roth MKM Health Opportunities Conference and the
2023 H.C. Wainwright 25th Annual Global Investment
Conference. During the quarter the Company was also proactive in
reaching out to analysts and investors to educate them about
Chemomab's programs and our future plans.
Third Quarter 2023 Financial Highlights
- Cash Position: Cash and cash equivalents were
$21.4 million as of September 30, 2023, compared to $26.7 million for the quarter ended June 30, 2023. The Company currently expects its
cash runway to last through year-end 2024.
- Research and Development (R&D) Expenses: R&D
expenses were $3.4 million for the
third quarter ended September 30,
2023, compared to $5.4 million
for the same quarter in 2022. The decrease in R&D expense
year-over-year primarily reflects a decrease in manufacturing costs
for clinical supplies, which was partly offset by increases in the
company's clinical program activities.
- General and Administrative (G&A) Expenses: G&A
expenses were $1.0 million for the
third quarter ended September 30,
2023, compared to $2.9 million
for the same quarter in 2022. The decrease was primarily due to a
decrease in salaries and related benefits expenses as well as a
decrease in non-cash share-based expenses.
- Net Loss: Net loss was $4.1
million, or a net loss of approximately $0.017 per basic and diluted share, for the third
quarter ended September 30, 2023,
compared to a net loss of $8.1
million, or a net loss of approximately $0.035 per basic and diluted share, for the
quarter ended September 30,
2022.
The weighted average number of Ordinary Shares outstanding,
basic and diluted, for the quarter ended September 30, 2023, was 236,449,153 (equal to
11,822,458 American Depository Shares) compared to 228,773,418
Ordinary Shares (equal to 11,438,671 American Depository Shares)
for the quarter ended September 30,
2022.
For further details on Chemomab's financial results for the
quarter ended September 30, 2023,
refer to the Report of Foreign Private Issuer on Form 6-K, which
was filed with the SEC on November 9,
2023.
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.
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 1b trial in NAFLD patients, a Phase 2a liver
fibrosis trial in NASH patients and an investigator-initiated study
in patients with severe lung injury. The CM-101 program for the
treatment of systemic sclerosis is Phase 2-ready and 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.
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)
|
|
|
|
September 30,
2023
|
December 31,
2022
|
|
|
|
|
Assets
|
|
Unaudited
|
Audited
|
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
|
9,156
|
13,519
|
Short term bank
deposits
|
|
12,216
|
26,374
|
Restricted
cash
|
|
72
|
77
|
Other receivables and
prepaid expenses
|
|
922
|
1,766
|
|
|
|
|
Total current
assets
|
|
22,366
|
41,736
|
|
|
|
|
Non-current
assets
|
|
|
|
Long term prepaid
expenses
|
|
603
|
733
|
Property and equipment,
net
|
|
319
|
367
|
Operating lease
right-of-use assets
|
|
130
|
227
|
Total non-current
assets
|
|
1,052
|
1,327
|
|
|
|
|
Total
assets
|
|
23,418
|
43,063
|
|
|
|
|
Current
liabilities
|
|
|
|
Trade
payables
|
|
731
|
1,688
|
Accrued
expenses
|
|
3,007
|
3,378
|
Employee and related
expenses
|
|
1,527
|
1,560
|
Operating lease
liabilities
|
|
105
|
123
|
|
|
|
|
Total current
liabilities
|
|
5,370
|
6,749
|
|
|
|
|
Non-current
liabilities
|
|
|
|
Operating lease
liabilities - long term
|
|
5
|
91
|
|
|
|
|
Total non-current
liabilities
|
|
5
|
91
|
|
|
|
|
Commitments and
contingent liabilities
|
|
|
|
|
|
|
|
Total
liabilities
|
|
5,375
|
6,840
|
|
|
|
|
Shareholders' equity
(*)
|
|
|
|
Ordinary shares no par
value - Authorized: 650,000,000 shares as of
September 30, 2023 and December
31, 2022
|
|
-
|
-
|
Issued and outstanding:
248,094,700 Ordinary shares as of September 30,
2023 and 232,636,700 as of December 31,
2022
|
|
-
|
-
|
Treasury share at cost
(11,640,460 Ordinary
shares as of September 30,
2023 and December 31, 2022)
|
|
(1,218)
|
(1,218)
|
Additional paid in
capital
|
|
103,884
|
101,260
|
Accumulated
deficit
|
|
(84,623)
|
(63,819)
|
|
|
|
|
Total shareholders'
equity
|
|
18,043
|
36,223
|
Total liabilities
and shareholders' equity
|
|
23,418
|
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
|
Nine
months
|
Nine
months
|
|
Ended
|
Ended
|
Ended
|
Ended
|
|
September
30,
|
September
30,
|
September
30,
|
September
30,
|
|
2023
|
2022
|
2023
|
2022
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
Research and
development
|
3,377
|
5,423
|
15,284
|
11,082
|
|
|
|
|
|
General and
administrative
|
990
|
2,894
|
6,327
|
8,809
|
|
|
|
|
|
Total operating
expenses
|
4,367
|
8,317
|
21,611
|
19,891
|
|
|
|
|
|
Financing expense
(income), net
|
(231)
|
(237)
|
(807)
|
27
|
|
|
|
|
|
Loss before
taxes
|
4,136
|
8,080
|
20,804
|
19,918
|
|
|
|
|
|
Taxes on income (tax
benefit)
|
(55)
|
-
|
-
|
(544)
|
|
|
|
|
|
Net loss for the
period
|
4,081
|
8,080
|
20,804
|
19,374
|
|
|
|
|
|
Basic and diluted loss
per Ordinary Share (*)
|
0.017
|
0.035
|
0.092
|
0.085
|
Weighted average number
of Ordinary Shares
outstanding, basic, and diluted (*)
|
236,449,153
|
228,773,418
|
226,449,755
|
228,349,115
|
|
(*) 1 American
Depositary Share (ADS) represents 20 Ordinary Shares
|
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SOURCE Chemomab Therapeutics, Ltd.