Chemomab Therapeutics Announces First Quarter 2024 Financial Results and Provides Corporate Update
09 Maio 2024 - 8:00AM
Chemomab Therapeutics Ltd. (Nasdaq:CMMB), (Chemomab), a
clinical-stage biotechnology company developing innovative
therapeutics for fibro-inflammatory diseases with high unmet need,
today announced financial and operating results for the first
quarter ended March 31, 2024, and provided a corporate update.
“These are exciting times for Chemomab. We began the new year
announcing early completion of enrollment in our CM-101 Phase 2
trial in patients with primary sclerosing cholangitis (PSC) six
months ahead of schedule, allowing us to move up our topline
readout to midyear 2024. This potentially transformative milestone
for Chemomab will be followed by additional significant catalysts
later this year or early in 2025, when we expect to report topline
results from the 33-week open label extension of the PSC trial as
well as feedback from the FDA on a possible Phase 3 trial design,”
said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief
Scientific Officer of Chemomab. “These achievements reflect the
superb work of our medical and clinical development teams and the
support of our PSC investigators, along with the enthusiastic
response of patients eager to help advance the quest for effective
new treatments.”
Dr. Mor added, “In the first months of 2024, we also reported
new peer reviewed publications further validating the role of our
CCL24 target and our CCL24-neutralizing antibody CM-101 in both PSC
and systemic sclerosis (SSc). Our CM-101 SSc program is Phase 2
ready with an open IND, and we look forward to initiating patient
enrollment when resources permit. Our robust patent estate for
CM-101 was reinforced with additional patents granted in the E.U.,
Brazil and Israel. In April, we hosted an expert PSC webinar that
included informative updates on diagnosis and treatment, as well as
emerging knowledge around the role of surrogate biomarkers and
other noninvasive clinical endpoints in PSC management and clinical
development. We look forward to building on these positive
developments during what we expect to be an eventful remainder of
the year.”
First Quarter 2024 and Recent Updates
- In April, 2024, Chemomab announced
the publication of a new study in the journal Arthritis Care and
Research that further confirms the key role of its novel target
CCL24 in systemic sclerosis. The longitudinal study of a cohort of
more than 200 SSc patients showed that CCL24 is associated with
increased mortality and disease severity across the fibrotic and
vascular manifestations of the disease.
- In April, 2024, Chemomab hosted a
well-attended webinar on primary sclerosing cholangitis featuring
Christopher Bowlus, MD, of UC Davis Health; Ricky Safer, founder
and CEO of PSC Partners Seeking a Cure and Massimo Pinzani, MD,
PhD, of the UCL Institute for Liver and Digestive Health and UPMC
ISMETT. Topics included an overview of current PSC diagnosis and
treatment, the emerging consensus around surrogate biomarkers and
other noninvasive clinical endpoints and the role of patient
advocacy groups in supporting advances in treatment. Click here for
a replay of the webinar.
- In March, 2024,
Chemomab reported that the European Patent Office had granted a new
patent for CM-101, Chemomab’s first-in-class monoclonal antibody,
covering the use of CM-101 and sequence-related anti-CCL24
antibodies for the treatment of hepatic (liver) diseases, including
PSC. In February, the company announced new patents were granted in
Brazil and Israel. The Brazilian patent includes claims broadly
covering CM-101 and related anti-CCL24 antibodies along with their
use for the treatment of fibrotic, inflammatory and autoimmune
diseases. The Israeli patent covers the use of CM-101 in the
treatment of hepatic diseases, including PSC. These patents
supplement the extensive protections afforded by CM-101 patents
issued and allowed in the U.S. and other major territories.
- In January, 2024, Chemomab reported
publication of new proteomics research in the peer-reviewed journal
Cells reinforcing the clinical potential of CM-101 in primary
sclerosing cholangitis. The proteomic analyses of human samples
highlighted the unique role of CCL24 in activating key PSC-related
disease mechanisms. These findings further confirm the potential of
CM-101 as a promising therapy for PSC.
- In January, 2024, Chemomab announced early completion of
patient enrollment in the CM-101 Phase 2 PSC SPRING trial and moved
up the expected topline data readout to midyear 2024, rather than
in the second half of 2024 as had been previously projected.
First Quarter
2024 Financial
Highlights
- Cash Position: Cash, cash equivalents and
short-term bank deposits were $16.0 million as of March 31, 2024,
compared to $19.9 million as of December 31, 2023.
- Research and Development (R&D) Expenses:
R&D expenses were $3.1 million for the first quarter of 2024,
compared to $6.9 million for the first quarter of 2023. The
decrease in R&D expenses in the first quarter of 2024 compared
to the first quarter of 2023 primarily resulted from the early
completion of patient enrollment in the company’s CM-101 Phase 2
PSC trial.
- General and Administrative (G&A) Expenses:
G&A expenses were $0.9 million for the first quarter of 2024,
compared to $2.2 million for the first quarter of 2023. The
decrease in G&A expenses primarily reflected reductions in
headcount, consulting fees and other cost savings.
- Net Loss: Net loss was $3.9 million, or a net
loss of approximately $0.01 per basic and diluted ordinary share
for the first quarter of 2024, compared to $8.8 million, or a net
loss of approximately $0.04 per basic and diluted ordinary share
for the first quarter of 2023. The weighted average number of
ordinary shares outstanding, basic and diluted, was 284,151,752
(equal to approximately 14.2 million ADSs) for the first quarter of
2024.
- Liquidity and Capital Resources: Chemomab
believes its existing liquidity resources as of March 31, 2024 will
enable it to fund its operations through March 31, 2025.
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
Company’s ability to regain compliance with Nasdaq’s Marketplace
Rule 5550(a)(2) prior to the expiration of the 360-day grace
period; the clinical development pathway for CM-101; the
expectation that Chemomab will report topline data from the PSC
clinical trial by midyear 2024; the Company’s ability to fund its
operations through March 31, 2025 based on its existing liquidity
resources; the length, duration and impact of the war in Israel on
Chemomab’s business and operations; 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 communication, 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
that neutralizes CCL24 activity. In clinical and preclinical
studies, CM-101 appears safe, with the potential to treat multiple
severe and life-threatening fibro-inflammatory diseases. Chemomab
has reported positive results from three clinical trials of CM-101
in patients, including a Phase 2a liver fibrosis trial in NASH
patients and an investigator-initiated study in patients with
severe lung injury. A Phase 2 trial in primary sclerosing
cholangitis has completed patient enrollment, with topline data
expected midyear 2024. Chemomab’s CM-101 program for the treatment
of systemic sclerosis is Phase 2-ready with an open U.S. IND. For
more information about Chemomab, visit chemomab.com.
Contacts:
Media &
Investors:Chemomab TherapeuticsBarbara
LindheimConsulting Vice PresidentInvestor & Public Relations,
Strategic CommunicationsPhone: +1
917-355-9234barbara.lindheim@chemomab.com IR@chemomab.com
Interim Unaudited Condensed Consolidated Balance
Sheet |
|
|
|
In
USD thousands (except for share amounts) |
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2024 |
|
2023 |
Assets |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
|
4,665 |
|
|
9,292 |
|
Short term bank deposits |
|
11,212 |
|
|
10,492 |
|
Restricted cash |
|
75 |
|
|
76 |
|
Other receivables and prepaid expenses |
|
885 |
|
|
1,037 |
|
|
|
|
|
Total current assets |
|
16,837 |
|
|
20,897 |
|
|
|
|
|
Non-current assets |
|
|
|
Long term prepaid expenses |
|
516 |
|
|
559 |
|
Property and equipment, net |
|
289 |
|
|
303 |
|
Operating lease right-of-use assets |
|
367 |
|
|
392 |
|
Total non-current assets |
|
1,172 |
|
|
1,254 |
|
|
|
|
|
Total assets |
|
18,009 |
|
|
22,151 |
|
|
|
|
|
Current liabilities |
|
|
|
Trade payables |
|
527 |
|
|
516 |
|
Accrued expenses |
|
3,401 |
|
|
3,423 |
|
Employee and related expenses |
|
360 |
|
|
823 |
|
Operating lease liabilities |
|
110 |
|
|
76 |
|
|
|
|
|
Total current liabilities |
|
4,398 |
|
|
4,838 |
|
|
|
|
|
Non-current liabilities |
|
|
|
Operating lease liabilities - long term |
|
280 |
|
|
316 |
|
|
|
|
|
Total non-current liabilities |
|
280 |
|
|
316 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
4,678 |
|
|
5,154 |
|
|
|
|
|
Shareholders' equity (*) |
|
|
|
|
|
|
|
Ordinary shares no par value - Authorized: 650,000,000 shares as of
March 31, 2024 and December 31, 2023; |
|
- |
|
|
- |
|
Issued and outstanding: 284,379,960 Ordinary shares as of March 31,
2024 and 284,094,700 as of December 31, 2023; |
|
- |
|
|
- |
|
|
|
|
|
|
|
|
Additional paid in capital |
|
105,877 |
|
|
105,675 |
|
Accumulated deficit |
|
(92,546 |
) |
|
(88,678 |
) |
|
|
|
|
Total shareholders’ equity |
|
13,331 |
|
|
16,997 |
|
Total liabilities and shareholders’ equity |
|
18,009 |
|
|
22,151 |
|
(*) 1 American Depositary Share (ADS) represents 20 Ordinary
Shares
Interim Unaudited Condensed Consolidated Statements of
Operations |
In
USD thousands (except for share and per share amounts) |
|
|
|
|
|
|
|
Three months |
|
Three months |
|
|
Ended |
|
Ended |
|
|
March 31, |
|
March 31, |
|
|
2024 |
|
2023 |
Operating expenses |
|
|
|
|
|
|
|
|
|
Research and development |
|
3,112 |
|
6,887 |
|
|
|
|
|
General and administrative |
|
936 |
|
2,162 |
|
|
|
|
|
Total operating expenses |
|
4,048 |
|
9,049 |
|
|
|
|
|
Financing income, net |
|
180 |
|
317 |
|
|
|
|
|
Loss before taxes |
|
3,868 |
|
8,732 |
|
|
|
|
|
Taxes on income |
|
- |
|
21 |
|
|
|
|
|
Net loss for the period |
|
3,868 |
|
8,753 |
|
|
|
|
|
Basic and diluted loss per Ordinary Share (*) |
|
0.014 |
|
0.040 |
Weighted average number of Ordinary Shares outstanding, basic, and
diluted (*) |
|
284,151,752 |
|
220,996,240 |
(*) 1 American Depositary Share (ADS) represents 20 Ordinary
Shares
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