-- Company to Host Conference Call for
Investors Today, May 12 at
8:00 am ET --
TEL
AVIV, Israel, May 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 first quarter
ended March 31, 2022 and provided a
corporate update.
"During the quarter we continued to make good progress in
refining and implementing revisions to our CM-101 clinical program
aimed at decreasing overall development risk, maximizing the
clinical data obtained to facilitate clinical decision-making, and
generating critical data to support advancement to registration
trials," said Dale Pfost, PhD, Chief
Executive Officer of Chemomab. "We are expanding our efforts in
primary sclerosing cholangitis (PSC) with an enlarged clinical
trial that is recruiting patients from new sites in the U.S. and
Europe, while adding an important
dose finding component and an open-label extension. We will be
performing an interim analysis of the currently enrolling dose
cohort in the PSC study to assess safety and to confirm the planned
sample sizes for the CM-101 dose cohorts. This planned interim
read-out is expected late this year."
Dr. Pfost added, "In systemic sclerosis (SSc), we expect the
revised Phase 2 trial design to enable an expedited path to
proof-of-concept data, and, importantly, to provide additional
information on CM-101's activity in modifying the skin, lung and
vascular pathophysiology seen in SSc patients. We are designing
this trial with the assistance of key SSc opinion leaders and are
on track to launch the trial by the end of the year. I am also
pleased to report that we have now completed enrollment in our
Phase 2 safety, pharmacokinetic and biomarker liver fibrosis study,
with final readouts expected near year's end. We continue to use
our capital efficiently and look forward to providing further
details on our progress with the PSC and SSc Phase 2 trials this
summer."
Recent Highlights:
- Named Jack Lawler Vice President of Global Clinical
Development Operations. Mr. Lawler, who is based in the U.S.,
brings the company more than 20 years of diverse global clinical
drug development experience.
- Chief Scientific Officer Dr. Adi
Mor presented "Blocking CCL24, a novel target regulating
inflammation fibrosis and endothelial damage, shows promising
potential as treatment for Systemic Sclerosis" at the biennial
International Rheumatology Conference in Israel. Study data from experimental models
and patient samples demonstrated that CCL24, the target for CM-101,
is overexpressed in skin and serum samples of diffuse SSc patients
compared to healthy individuals. CCL24 levels also correlated with
fibrotic biomarkers and disease progression. In an experimental
mouse model of SSc, CM-101 profoundly reduced skin and lung
fibrosis.
- Professor Francesco Del Galdo of
the University of Leeds presented "CCL24 as a Marker of Worse
Prognosis in diffuse cutaneous SSc: a Promising Novel Biological
Target" at the 7th Systemic Sclerosis World
Congress. Professor Del Galdo's findings support the role
of CCL24 as a potential therapeutic target, demonstrating elevated
serum levels of CCL24 in diffuse cutaneous SSc patients. High CCL24
serum levels were correlated with disease activity and worse
prognosis as reflected by high fibrotic activity and deterioration
of lung function over time in a longitudinal patient cohort.
- Participated in the 32nd Annual Oppenheimer
Healthcare Conference
- At the Cantor Fitzgerald Rare Orphan Disease Summit, Dr.
Adi Mor described how Chemomab's
CM-101 "pipeline in a product" strategy offers important synergies
and efficiencies in the drug development process.
First Quarter 2022 Financial Highlights
- Cash Position: Cash and cash equivalents were
$57.5 million as of March 31, 2022, compared to $61.2 million as of December 31, 2021.
- Research and Development (R&D) Expenses: R&D
expenses were $2.7 million for the
first quarter ended March 31, 2022,
compared to $1.2 million for the same
quarter in 2021.
- General and Administrative (G&A)
Expenses: G&A expenses were $2.6 million for the first quarter ended
March 31, 2022, compared to
$0.5 million for the same quarter in
2021. The current quarter figure includes a $0.9 million non-cash stock-based compensation
payment.
- Net Loss: Net loss was $5.1
million, or a net loss of $0.02 per basic and diluted share, for the first
quarter ended March 31, 2022,
compared to $1.7 million, or a net
loss of $0.01 per basic and diluted
share, for the quarter ended March
31, 2021. The weighted average number of Ordinary
Shares outstanding, basic and diluted were 228,090,300 (equal to
11,404,515 American Depository Shares) and 156,751,771 (equal to
7,837,589 American Depository Shares) for the quarters ended
March 31, 2022, and March 31, 2021, respectively.
For further details on the company's financial results for the
quarter ended March 31, 2022, refer
to the Form 10-Q, which will be filed with the SEC today,
May 12, 2022.
Conference Call
Chemomab management will host a
conference call for investors today, Thursday, May 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 13728593. Ask
for the Chemomab conference call. The call also will be webcast
live on the company's website at
https://investors.chemomab.com/events
A replay of the call will be available on the company 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 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: 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
Condensed
Consolidated Balance Sheets
|
In USD thousands (except share amounts)
|
|
|
|
March
31,
|
December
31,
|
|
|
2022
|
2021
|
Assets
|
|
Unaudited
|
Audited
|
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
|
13,827
|
15,186
|
Short term bank
deposits
|
|
43,579
|
45,975
|
Other receivables and
prepaid expenses
|
|
1,934
|
1,527
|
|
|
|
|
Total current
assets
|
|
59,340
|
62,688
|
|
|
|
|
Non-current
assets
|
|
|
|
Long term prepaid
expenses
|
|
864
|
908
|
Property and equipment,
net
|
|
358
|
357
|
Restricted
cash
|
|
85
|
55
|
Operating lease
right-of-use assets
|
|
309
|
345
|
Total non-current
assets
|
|
1,616
|
1,665
|
|
|
|
|
Total
assets
|
|
60,956
|
64,353
|
|
|
|
|
Current
liabilities
|
|
|
|
Trade
payables
|
|
1,487
|
1,336
|
Accrued
expenses
|
|
1,248
|
555
|
Employee and related
expenses
|
|
666
|
653
|
Operating lease
liabilities
|
|
116
|
106
|
|
|
|
|
Total current
liabilities
|
|
3,517
|
2,650
|
|
|
|
|
Non-current
liabilities
|
|
|
|
Operating lease
liabilities - long term
|
|
203
|
237
|
|
|
|
|
Total non-current
liabilities
|
|
203
|
237
|
|
|
|
|
Commitments and
contingent liabilities
|
|
|
|
|
|
|
|
Total
liabilities
|
|
3,720
|
2,887
|
|
|
|
|
Shareholders'
equity
|
|
|
|
Ordinary shares no par
value - Authorized: 650,000,000 shares as of March
31, 2022 and as of December 31,
2021;
Issued and outstanding:
228,090,300 ordinary shares as of March 31, 2022 and as of December
31, 2021
|
|
|
|
|
|
|
|
-
|
-
|
|
|
|
|
-
|
-
|
Additional paid in
capital
|
|
98,513
|
97,639
|
Accumulated
deficit
|
|
(41,277)
|
(36,173)
|
|
|
|
|
Total shareholders'
equity
|
|
57,236
|
61,466
|
Total liabilities
and shareholders' equity
|
|
60,956
|
64,353
|
Condensed
Consolidated Interim Statements of Operations
(Unaudited)
|
In USD thousands
|
|
|
Three
months
|
Three
months
|
|
Ended
|
Ended
|
|
March
31,
|
March
31,
|
|
2022
|
2021
|
|
|
Operating
expenses
|
|
|
|
|
|
Research and
development
|
2,745
|
1,157
|
|
|
|
General and
administrative
|
2,575
|
542
|
|
|
|
Total operating
expenses
|
5,320
|
1,699
|
|
|
|
Financing expenses
(income), net
|
(216)
|
5
|
|
|
Net loss for the
period
|
5,104
|
1,704
|
|
|
|
|
|
|
Basic and diluted loss
per Ordinary Share*
|
0.022
|
0.011
|
|
|
|
Weighted average number
of Ordinary Shares outstanding,
basic, and diluted*
|
228,090,300
|
156,751,771
|
* Number of shares has
been retroactively adjusted based on the equivalent number of
shares received by the accounting acquirer's shareholders in the
reverse recapitalization transaction.
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/chemomab-therapeutics-announces-first-quarter-2022-financial-results-and-provides-corporate-update-301545733.html
SOURCE Chemomab Therapeutics, Ltd.