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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
 
FORM 10-Q
 
(Mark One)
 
 QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the quarterly period ended March 31, 2023
 
OR
 
 TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from to
Commission File Number: 001-38807
 
Chemomab Therapeutics Ltd.
(Exact Name of Registrant as Specified in its Charter)
 
Israel
 
81-3676773
 
 
 
(State or other jurisdiction of
incorporation or organization)
 
(I.R.S. Employer
Identification No.)
 
 
 
Kiryat Atidim, Building 7
Tel Aviv, Israel 6158002
(Address of principal executive offices including zip code)
 
Registrant’s telephone number, including area code: +972-77-331-0156
Securities registered pursuant to Section 12(b) of the Exchange Act:
 
Title of each class
Trading Symbol(s)
 
Name of each exchange on which registered
American Depositary Shares, each representing twenty (20) ordinary shares, no par value per share
 
CMMB
Nasdaq Capital Market
Ordinary shares, no par value per share 
n/a
Nasdaq Capital Market*
 
*Not for trading; only in connection with the registration of American Depository Shares
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
 
Yes ☒    No ☐
 
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
 
Yes ☒    No ☐
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
 
Large accelerated filer
 
Accelerated filer
 
Non-accelerated filer
 
Smaller reporting company
 
 
 
 
Emerging growth company
 
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
 
Yes ☐    No
 
As of May 8, 2023, the registrant had 11,049,812 American Depositary Shares outstanding.
 

 
CHEMOMAB THERAPEUTICS LTD.
 
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTER ENDED MARCH 31, 2023 
 
TABLE OF CONTENTS 
 
1
 
 
1
 
 
10
 
 
18
 
 
18
 
 
19
 
 
19
 
 
19
 
 
19
 
 
21
 
 
19
 
 
19
 
 
20
 
 
21
 

 
CAUTIONARY NOTE ABOUT FORWARD-LOOKING STATEMENTS 
 
This Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical fact are “forward-looking statements” for purposes of this Quarterly Report on Form 10-Q. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” or the negative of these terms or other similar expressions. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Actual results or events could differ materially from those set forth or implied by such forward-looking statements and related assumptions due to certain factors, including, without limitation, the risks set forth under the caption “Risk Factors” below, which are incorporated herein by reference as well as those business risks and factors described elsewhere in this report and in our other filings with the Securities and Exchange Commission (the “SEC”), specifically our most recent Annual Report on Form 10-K, our Quarterly Reports on Form 10-Q and our filed Current Reports on Form 8-K. All forward-looking statements speak only as of the date made, and we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
 
CERTAIN TERMS USED IN THIS QUARTERLY REPORT ON FORM 10-Q 
 
As used in this Quarterly Report on Form 10-Q, unless the context otherwise requires:
 
 
references to “Chemomab Therapeutics Ltd.”, “Chemomab,” the “Company,” “us,” “we” and “our” refer to Chemomab Therapeutics Ltd. an Israeli company and its consolidated subsidiaries, although with respect to the presentation of financial results for historical periods that preceded the Merger (as defined below), these terms refer to the financial results of Chemomab Ltd., which was the accounting acquirer in the Merger;
 
 
references to “ordinary shares,” “our shares” and similar expressions refer to the Company’s ordinary shares, no nominal (par) value;
 
 
references to “ADS” refer to the American Depositary Shares listed on the Nasdaq Capital Market (“Nasdaq”) under the symbol “CMMB,” each representing twenty (20) ordinary shares;
 
 
references to “dollars,” “U.S. dollars” and “$” are to U.S. Dollars;
 
 
references to “NIS” are to New Israeli Shekels;
 
 
references to the “SEC” are to the U.S. Securities and Exchange Commission; and
 
 
references to the “Merger” refer to the merger involving Anchiano Therapeutics Ltd. and Chemomab Ltd., whereby a wholly owned subsidiary of Anchiano Therapeutics Ltd. merged with and into Chemomab Ltd., with Chemomab Ltd. surviving as a wholly owned subsidiary of Anchiano Therapeutics Ltd. Upon consummation of the Merger, Anchiano Therapeutics Ltd. changed its name to “Chemomab Therapeutics Ltd.” and the business conducted by Chemomab Ltd. became primarily the business conducted by the Company.
 

 PART I. – FINANCIAL INFORMATION
 
Item 1. Financial Statements
 
Chemomab Therapeutics Ltd. and
its subsidiaries
 
Condensed Consolidated Interim
Financial Statements
 
As of March 31, 2023
 
(Unaudited)
 

Chemomab Therapeutics Ltd.
and its subsidiaries
 
Unaudited Condensed Consolidated Interim Financial Statements as of March 31, 2023
 
Contents
 
 
2

 
Chemomab Therapeutics Ltd.
and its subsidiaries
 
Condensed Consolidated Balance Sheets
In USD thousands (except for share amounts)
 
         
March 31,
   
December 31,
 
   
Note
   
2023
   
2022
 
 
       
Unaudited
   
Audited
 
Assets
                 
                   
Current assets
                 
Cash and cash equivalents
         
20,765
     
13,519
 
Short term bank deposits
         
11,941
     
26,374
 

Restricted cash

         

77

     

77

 
Other receivables and prepaid expenses
         
995
     
1,766
 
                       
Total current assets
         
33,778
     
41,736
 
                       
Non-current assets
                     
Long term prepaid expenses
         
690
     
733
 
Property and equipment, net
         
352
     
367
 
Operating lease right-of-use assets
         
193
     
227
 
Total non-current assets
         
1,235
     
1,327
 
                       
Total assets
         
35,013
     
43,063
 
                       
Current liabilities
                     
Trade payables
         
2,217
     
1,688
 
Accrued expenses
         
3,164
     
3,378
 
Employee and related expenses
         
1,501
     
1,560
 
Operating lease liabilities
         
115
     
123
 
                       
Total current liabilities
         
6,997
     
6,749
 
                       
Non-current liabilities
                     
Operating lease liabilities - long term
         
62
     
91
 
                       
Total non-current liabilities
         
62
     
91
 
                       
Commitments and contingent liabilities
                 
                       
Total liabilities
         
7,059
     
6,840
 
                       
Shareholders' equity
 
1
                 
                       
Ordinary shares no par value - Authorized: 650,000,000 shares as of  March 31, 2023 and December 31, 2022; 
         
-
     
-
 
                       
Issued and outstanding: 232,636,700 Ordinary shares as of March 31, 2023 and  December 31, 2022; 
         
-
     
-
 
                       

Treasury share at cost (11,640,460 Ordinary shares as of March 31, 2023 and December 31, 2022)

         

(1,218

)    

(1,218

)
Additional paid in capital
         
101,744
     
101,260
 
Accumulated deficit
         
(72,572
)
   
(63,819
)
                       
Total shareholders’ equity
         
27,954
     
36,223
 
Total liabilities and shareholders’ equity
         
35,013
 
   

43,063

 
 
The accompanying notes are an integral part of the condensed consolidated interim financial statements.
3

 
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
 
         
Ended
   
Ended
 
         
March  31,
   
March 31,
 
   
 
   
2023
   
2022
 
Operating expenses
                 
                   
Research and development
         
6,887
     
2,745
 
                       
General and administrative
         
2,162
     
2,575
 
                       
Total operating expenses
         
9,049
     
5,320
 
                       
Financing income, net
         
(317
)
   
(216
)
                       
Loss before taxes
         
8,732
     
5,104
 
                       
Taxes on income
         
21
     
-
 
                       
Net loss for the year
         
8,753
     
5,104
 
                       
Basic and diluted loss per Ordinary Share (*)
         
0.040
     
0.022
 
                       
Weighted average number of Ordinary Shares outstanding, basic, and diluted (*)
         
220,996,240
     
228,090,300
 
 
(*) 20 Ordinary Shares are equal to 1 American Depositary Share (ADS).
 
The accompanying notes are an integral part of the condensed consolidated interim financial statements.
4

 
Chemomab Therapeutics Ltd.
and its subsidiaries
 
Condensed Consolidated Interim Statements of Changes in Equity (Unaudited)
In USD thousands (except share amounts)
 
   
Ordinary
Share
   

Treasury
share

   
Additional
paid in
capital
     
Accumulated
Deficit
   
Total
Shareholders’
equity
 
    Number       USD    

Number

    USD     USD       USD     USD  
For the three-month period ended on March 31, 2023
                                                 
Balance as of January 1, 2023
   
232,636,700
     
-
     

(11,640,460

)

   

(1,218

)

 

101,260

 

   
(63,819
)    
36,223
 
Share-based compensation
   
-
     
-
      -       -      
484
     
-
     
484
 
Net loss for the year
   
-
     
-
      -       -      
-
     
(8,753
)    
(8,753
)
Balance as of March 31, 2023
   
232,636,700
     
-
     

(11,640,460

)

   

(1,218

)

   
101,744
     
(72,572
)    
27,954
 
 
5

 
Chemomab Therapeutics Ltd.
and its subsidiaries
 
Condensed Consolidated Interim Statements of Changes in Equity (Unaudited)
In USD thousands (except share amounts)
 
   
Ordinary
Shares
   
Additional
paid in
capital
   
Accumulated
Deficit
   
Total
Shareholders’
equity
 
   
Number
    USD     USD     USD     USD  
For the three-month period ended on March 31, 2022
                             
Balance as of January 1, 2022
   
228,090,300
     
-
     
97,639
     
(36,173
)
   
61,466
 
Share-based compensation
   
-
     
-
     
874
     
-
     
874
 
Net loss for the period
   
-
     
-
     
-
     
(5,104
)
   
(5,104
)
Balance as of March 31, 2022
   
228,090,300
     
-
     
98,513
     
(41,277
)
   
57,236
 
 
The accompanying notes are an integral part of the condensed consolidated interim financial statements.
6

 
Chemomab Therapeutics Ltd.
and its subsidiaries
 
Condensed Consolidated Interim Statements of Cash flows (Unaudited)
In USD thousands
 
   
Three months
   
Three months
 
   
ended
   
Ended
 
   
March 31,
   
March 31,
 
   
2023
   
2022
 
Cash flows from operating activities
           
Net loss for the period
   
(8,753
)
   
(5,104
)
                 
Adjustments for operating activities:
               
Depreciation
   
16
     
13
 
Share-based compensation
   
484
     
874
 
Change in other receivables and prepaid expenses
   
814
     
(363
)
Change in operating lease liability
   
(3
)
   
12
 
Change in trade payables
   
529
     
151
 
Change in accrued expenses
   
(214
)
   
693
 
Change in employees and related expenses
   
(59
)
   
13
 
     
1,567
     
1,393
 
Net cash used in operating activities
   
(7,186
)
   
(3,711
)
                 
Cash flows from investing activities
               
Decrease in bank deposits
   
14,433
     
2,396
 
Purchase of property and equipment
   
(1
)
   
(14
)
Net cash provided by investing activities
   
14,432
     
2,382
 
                 
Cash flows from financing activities
               
                 
Net cash provided by financing activities
   
-
     
-
 
                 
Change in cash, cash equivalents and restricted cash
   
7,246
     
(1,329
)
                 
Cash, cash equivalents and restricted cash at beginning of period
   
13,596
     
15,241
 
                 
Cash, cash equivalents and restricted cash at end of period
   
20,842
     
13,912
 
 
The accompanying notes are an integral part of the condensed consolidated interim financial statements.
7

 
CHEMOMAB THERAPEUTICS LTD AND ITS SUBSIDIARIES
 (FORMERLY ANCHIANO THERAPEUTICS LTD.)
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
 
Note 1 - General.
 
  A.

Chemomab Therapeutics Ltd. (the “Company") is an Israeli-based company incorporated under the laws of the State of Israel in September 2011. The Company’s registered office is located in Kiryat Atidim, Tel Aviv, Israel. The Company is a clinical-stage biotech company discovering and developing innovative therapeutics for conditions with high-unmet medical need that involve inflammation and fibrosis. 

 
 

B.

The Company currently has no products approved for sale. The Company’s operations are funded primarily by its Shareholders. The Company has incurred operating losses in each year since its inception and does not expect to generate significant revenue unless and until it obtains marketing approval for its products. Continuation of the Company’s development programs depend on its future ability to raise sources of financing. The Company believes that its existing liquidity resources as of March 31, 2023 will enable it to fund its operations through June 30, 2024 with the ability to perform cost reductions in order to extend the operations even further, if required to do so.

     
  C.

On April 30, 2021, the Company entered into an At the Market Offering Agreement (the "ATM Agreement") with Cantor Fitzgerald & Co., ("Cantor"). According to the ATM Agreement, the Company may offer and sell, from time to time, its ADSs having an aggregate offering price of up to $75 million through Cantor or the ATM Agreement. From April 30, 2021, through March 31, 2023 the Company issued 699,806 ADSs at an average price of $22.75 per ADS under the ATM Agreement, resulting in gross proceeds of $15,917 thousand.

 
  D.

On April 25, 2022, the Company filed a prospectus supplement with the SEC for the issuance and sale of up to  $18,125,000 of its ADSs in connection with the reactivation of the ATM Facility and pursuant to General Instruction I.B.6 of Form S-3, which, subject to certain exceptions, limits the amount of securities the Company is able to offer and sell under such registration statement to one-third of our unaffiliated public float. During the year ended December 31, 2022, the Company issued 130,505 ADSs at an average price of $2.11 per ADS under the ATM Agreement, resulting in gross proceeds of $275 thousand.

 

On March 22, 2023 the Company filed with the SEC an amendment to registration statement on form S-1/A for the issuance and sale of up to  $10 million of its ADSs.


On March 27, 2020 and December 27, 2020, the President of the United States signed and enacted into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) and the Consolidated Appropriations Act, 2021 (CAA). Among other provisions, the CARES Act and the CAA provide relief to U.S. federal corporate taxpayers through temporary adjustments to net operating loss rules, changes to limitations on interest expense deductibility, and the acceleration of available refunds for minimum tax credit carryforwards. The CARES Act also includes provisions for a carryback of any net operating loss (NOL) arising in a taxable year beginning after December 31, 2017, and before January 1, 2021, to each of the five taxable years preceding the taxable year in which the loss arises (carryback period).

 

Chemomab Therapeutics Inc., a wholly owned subsidiary of the Company, filed an application with the US Internal Revenue Service to carryback net operating losses. The Company received $351 thousand in 2022 and $187 thousand in March 2023.

 

8


 

CHEMOMAB THERAPEUTICS LTD AND ITS SUBSIDIARIES
(FORMERLY ANCHIANO THERAPEUTICS LTD)
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

 

Note 2 - Basis of Presentation and Significant Accounting Policies
 
 
A.
Basis of Preparation
 
The condensed interim consolidated financial statements included in this quarterly report are unaudited. These financial statements have been prepared in accordance with U.S. GAAP and applicable rules and regulations of the SEC regarding interim financial reporting and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for a fair statement of the Company’s financial position as of March 31, 2023, and its results of operations for the three ended March 31, 2023, and 2022, changes in shareholders’ equity for the three months ended March 31, 2023 and 2022, and cash flows for the three months ended March 31, 2023 and 2022. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any other future annual or interim period. These financial statements should be read in conjunction with the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 and Form 10-Q for the three months ended March 31, 2023 filed with the SEC. The Company’s significant accounting policies are disclosed in the audited financial statements for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies.
 
 
B.
Use of estimates
 
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from those estimates.

 

Note 3 - Contingencies
 
During 2022, the Israeli tax authority ("ITA”) notified the Company that it had initiated a routine VAT audit to include tax years 2017 through 2020. The ITA raised several claims, mainly in respect with the recoverability of VAT with respect to Merger Agreement related expenses and the classification of the Company as a holding company. On July 2022, the ITA proposed a settlement, which the Company rejected. As a result, the ITA issued an assessment. The Company plans to appeal the ITA’s assessment. The Company has recorded a provision in 2022 which is inherently subjective due to the inherent uncertainty of these matters and the judicial process. Therefore, the outcome may differ from the estimated liability recorded by the Company during the period.

9

 
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q, as well as our audited consolidated financial statements and related notes for the year ended December 31, 2022, as filed in our Annual Report on Form 10-K for the year ended December 31, 2022 (the “2022 Annual Report”). Some of the information contained in this discussion and analysis, particularly with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. You should read “Risk Factors” in Item 1A of our 2022 Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. 
 
Overview 
 
We are a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet needs. Based on the unique and pivotal role of the soluble protein CCL24 in promoting fibrosis and inflammation, We developed CM-101, a monoclonal antibody designed to bind and block CCL24 activity. We believe CM-101 has demonstrated the potential to treat multiple severe and life-threatening fibrotic and inflammatory diseases.
 
We have pioneered the therapeutic targeting of CCL24, a chemokine that promotes various types of cellular processes that regulate inflammatory and fibrotic activities through the CCR3 receptor. CCL24 is expressed in various types of cells, including immune cells, endothelial cells and epithelial cells. We have developed a novel CCL24-inhibiting product candidate with dual anti-fibrotic and anti-inflammatory activity that modulates the complex interplay of both of these inflammatory and fibrotic mechanisms, which drives abnormal states of fibrosis and clinical fibrotic diseases. This innovative approach is being developed for difficult-to-treat rare diseases, also known as orphan indications or diseases, such as primary sclerosing cholangitis, or PSC, and systemic sclerosis, or SSc, for which patients have no established disease modifying standard of care treatment options. We estimate that there are approximately 77 thousand patients suffering from PSC in the U.S., EU and Japan, representing an estimated $1 billion market opportunity, and approximately 170 thousand patients suffering from SSc in those same markets, representing an estimated $1.5 billion market opportunity.
 
CM-101, our lead clinical product candidate, is a first-in-class humanized monoclonal antibody that attenuates the basic function of CCL24, also known as eotaxin-2, as a regulator of major inflammatory and fibrotic pathways. We have demonstrated that CM-101 interferes with the underlying biology of inflammation and fibrosis through a novel and differentiated mechanism of action. Based on these findings, we are actively advancing CM-101 in Phase 2 clinical studies directed toward two distinct clinical indications that include patients with liver or skin, and/or lung fibrosis. We are currently conducting a Phase 2 clinical study in PSC, a rare obstructive and cholestatic liver disease. The study is actively recruiting patients in the U.S., Europe and Israel and includes two dose arms (10 and 20mg/kg) as well as an open label extension.
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We are also planning to open a Phase 2 clinical trial in SSc about midyear 2023. The trial in SSc, a rare autoimmune rheumatic disease characterized by fibrosis in the skin and lung and other organs, will focus on establishing biological and clinical proof of concept in this patient population. Although our primary focus is on these two rare indications, as we noted, an additional Phase 2 clinical study in patients with liver fibrosis due to non-alcoholic steatohepatitis, or NASH was completed late last year.  This trial provided safety and pharmacokinetic (PK) data on CM-101 in this patient population and was informative for determining whether the company advances the development of its current subcutaneous formulation of CM-101. Additionally, the trial measured a number of biomarkers that may be relevant to the potential activity of CM-101 in NASH and in other fibro-inflammatory conditions. We reported results from this trial in January 2023 that showed that the trial met its primary endpoint of safety and tolerability, and that CM-101 demonstrated encouraging activity in secondary endpoints that include a range of liver fibrosis biomarkers and physiologic assessments.
 
Fibrosis is the abnormal and excessive accumulation of collagen and extracellular matrix, the non-cellular component in all tissues and organs, which provides structural and biochemical support to surrounding cells. When present in excessive amounts, collagen and extracellular matrix lead to scarring and thickening of connective tissues, affecting tissue properties and potentially leading to organ dysfunction and failure. Fibrosis can occur in many different tissues, including lung, liver, kidney, muscle, skin, and the gastrointestinal tract, resulting in a wide array of progressive fibrotic conditions. Fibrosis and inflammation are intrinsically linked. While a healthy inflammatory response is necessary for efficient tissue repair; after disease or injury, an excessive, uncontrolled inflammatory response can lead to tissue fibrosis that in turn can further stimulate inflammatory processes in a fibro-inflammatory vicious cycle.
 
Recent Developments
 
FDA Clearance of our IND Application to Study CM-101 in a Phase 2 Trial in SSc Patients
 
On February 21, 2023, we reported U.S. Food and Drug Administration (FDA) clearance of our Investigational New Drug (IND) Application to evaluate CM-101 in a Phase 2 trial in adults with systemic sclerosis (SSc). The Phase 2 ABATE trial is a multicenter, randomized, double-blind, proof-of-biology study to evaluate the sAfety, toleraBility, and Activity of CM-101 in patients with sysTEmic sclerosis. It expects to enroll 45 patients with clinically active dermatologic, vascular or pulmonary SSc. The study population is expected to be roughly split between patients with diffuse SSc and patients with limited SSc. The primary outcome measure is safety. Secondary endpoints include multiple serum-based biological markers and a variety of exploratory biological and clinical outcomes, including the American College of Rheumatology Composite Response Index in Systemic Sclerosis (ACR-CRISS) score and its revisions (rCRISS). The trial includes a 24-week double blind period during which active treatment patients will receive 10 mg/kg of CM-101 by intravenous infusion every three weeks, followed by a 24-week open label extension, where all patients will receive a 10 mg/kg dose. The trial includes multiple clinical assessments of the skin, vasculature and pulmonary function. It is expected to generate additional information about disease mechanisms, provide data relevant to future patient stratification strategies and inform the selection of appropriate endpoints for future studies. The trial is expected to begin enrolling patients around midyear 2023. A data read-out is targeted for the second half of 2024.
 
Report Topline Results from CM-101 Phase 2a Liver Fibrosis Biomarker Trial in NASH Patients
 
On January 3, 2023, we reported positive topline results from our Phase 2a liver fibrosis biomarker trial of CM-101 in NASH patients. This trial was primarily designed to assess a subcutaneous formulation of CM-101 and to evaluate the drug’s impact on liver fibrosis biomarkers relevant to both NASH and the fibro-inflammatory conditions that represent the focus for the company, such as PSC and SSc. The trial met its primary endpoint of safety and tolerability, and CM-101 demonstrated encouraging activity in secondary endpoints that include a range of liver fibrosis biomarkers and physiologic assessments measured at baseline and at week 20.
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The randomized, placebo-controlled trial enrolled 23 NASH patients with stage F1c, F2 and F3 disease who were randomized to receive either CM-101 or placebo. Patients received a dose of 5 mg/kg of study drug administered by subcutaneous (SC) injection once every two weeks, for a treatment period of 16 weeks. Key findings of the CM-101 Phase 2a trial included the following.
 
 
CM-101 appeared to be safe when administered subcutaneously. Most reported adverse events observed were mild, with one unrelated serious adverse event reported. No significant injection site reactions were reported and no anti-drug antibodies were detected.
 
 
CM-101 administered subcutaneously demonstrated favorable pharmacokinetics and target engagement profiles as expected, and were similar to what the company has previously reported.
 
 
CM-101-treated patients showed greater improvements than the placebo group in a number of liver fibrosis-related biomarkers, including ProC-3, ProC-4, ProC-18, TIMP-1 and ELF.
 
 
A majority of CM-101-treated patients showed improvements in multiple liver fibrosis-related biomarkers—almost 60% of CM-101 patients were “multiple responders”, responding in at least three biomarkers at week 20, compared to no patients in the placebo group.
 
 
CM-101-treated patients with higher CCL24 levels at baseline showed greater reductions in fibrosis-related biomarkers than patients with lower levels of CCL24 at baseline. More CM-101-treated patients with higher CCL24 levels also were “multiple responders”, responding in three or more of the fibrosis-related biomarkers, compared to patients with lower CCL24 levels at baseline. These findings further add to the growing body of evidence validating the role of CCL24 in the pathophysiology of fibrotic liver disease.
 
 
A higher proportion of patients in the CM-101-treated group showed improvement in a physiologic measure of liver stiffness as compared to placebo (reduction of at least one grade of fibrosis score as assessed by the non-invasive elastography method known as FibroScan®).
 
 
After completion of the study, the unblinded data showed that patients in the CM-101-treated group had higher baseline levels of fibrosis compared to placebo patients. The impact of this difference on the results, if any, is unknown.
 
We believe that the data from this trial provide important insights in support of the CM-101 development program, including the favorable safety and tolerability of CM-101 in patients with serious liver disease, confirmation of early signs of biomarker activity that are relevant for a number of fibro-inflammatory disorders, and support for the tolerability and pharmacokinetic data needed to assess next steps in the development of our SC formulation.
12

 
Corporate Information 
 
We were incorporated on September 22, 2011, under the laws of the State of Israel. In March 2021, in connection with the Merger, we changed our name from Anchiano Therapeutics Ltd. to Chemomab Therapeutics Ltd. Our principal executive offices are located at Kiryat Atidim, Building 7, Tel Aviv, Israel 6158002, and our phone number is +972-77-331-0156. Our website is: www.chemomab.com. The information contained on, or that can be accessed through, our website is not incorporated by reference into this Quarterly Report on Form 10-Q. We have included our website address as an inactive textual reference only.  
 
Components of Operating Results 
 
References to “we,” “us,” “our” and “Chemomab” in this “Components of Operating Results” and in the “Results of Operations” below refer to the Company after the Merger, and, with respect to historical periods preceding the Merger, refer to Chemomab Ltd., whose business became the business of the Company upon consummation of the Merger. 
 
Revenues 
 
To date, we have not generated any revenue. We do not expect to generate revenue unless and until we obtain regulatory approval and commercialize a product candidate, or until we receive revenue from a collaboration such as a co-development or out-licensing agreement. There can be no assurance that we will receive such regulatory approvals, and if any product candidate is approved, that we will be successful in commercializing it.
 
Research and Development Expenses 
 
Research and development expenses consist primarily of costs incurred in connection with the development of our product candidates. These expenses include:
 
 
expenses incurred under agreements with contract research organizations or contract manufacturing organizations, as well as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services;
 
 
manufacturing scale-up expenses and the cost of acquiring and manufacturing preclinical and clinical trial materials;
 
 
employee-related expenses, including salaries, related benefits, travel and share-based compensation expenses for employees engaged in research and development functions, as well as external costs, such as fees paid to outside consultants engaged in such activities;
 
 
license maintenance fees and milestone fees incurred in connection with various license agreements;
 
 
costs related to compliance with regulatory requirements; and
 
 
depreciation and other expenses.
 
We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers.
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We do not allocate employee costs or facility expenses, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We use our internal resources primarily to oversee research, as well as for managing our preclinical development, process development, manufacturing and clinical development activities. Our employees work across multiple programs and, therefore, we do not track costs by program.
 
Research and development activities are fundamental to our business. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will increase substantially over the next several quarters and years as we continue to advance the development of our product candidates. We also expect to incur additional expenses related to milestone and royalty payments payable to third parties with whom we have entered into license agreements to acquire the rights to its product candidates.
 
General and Administrative Expenses 
 
General and administrative expenses consist primarily of salaries, related benefits and share-based compensation expenses for personnel in executive and administrative functions. General and administrative expenses also include professional fees for legal, consulting, accounting and audit services.
 
We anticipate that our general and administrative expenses will increase in the future as we increase headcount and general activities to support our continued research activities and development of our product candidates as well as expanding our presence in the United States. We also anticipate that we will incur increased headcount, accounting, audit, legal, regulatory, compliance, director and officer insurance costs, as well as investor and public relations expenses associated with being a public company. We expect that the additional costs for these services will substantially increase our general and administrative expenses. Additionally, if and when we believe that regulatory approval of a product candidate appears likely, we expect to incur an increase in payroll and related expenses as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of any product candidate.
 
Results of Operations 
 
Three Months Ended March 31, 2023 Compared to the Three Months Ended March 31, 2022 
 
Below is a summary of our results of operations for the periods indicated:
 
 
 
Three months ended
             
 
 
March 31,
   
Increase/(decrease)
 
 
 
2023
   
2022
    $    
%
 
 
 
(in thousands)
               
Operating expenses:
                         
Research and development
   
6,887
     
2,745
     
4,142
     
151
%
General and administrative
   
2,162
     
2,575
     
(413
)
   
(16
)%
Operating loss
   
9,049
     
5,320
     
3,729
     
70
%
Financing income, net
   
(317
)
   
(216
)
   
(101
)
   
47
%
Loss before taxes
   
8,732
     
5,104
     
3,628
     
71
%
Taxes on income
   
21
     
-
     
21
     
100
%
Net loss
 
$
8,753
   
$
5,104
   
$
3,649
     
71
%
 
Our results of operations have varied in the past and can be expected to vary in the future due to numerous factors. We believe that period-to-period comparisons of our operating results are not necessarily meaningful and should not be relied upon as indications of future performance.
14

 
Research and development expenses 
 
Research and development expenses increased by approximately $4.1 million, or 151%, for the three months ended March 31, 2023, as compared to the same period of 2022. The increase was primarily due to increased clinical and preclinical activities.
 
General and administrative expenses 
 
General and administrative expenses decreased by approximately $0.4 million, or 16%, for the three months ended March 31, 2023, as compared to the same period of 2022. The decrease was primarily due to a decrease in non-cash share-based expenses and decrease in insurance expenses.
 
Financing income, net 
 
Financing income, net for the three months ended March 31, 2023 was $317 thousand. Financing income, net for the three months ended March 31, 2022 was $216 thousand. This reflects an increase in finance income, net of $101 thousand, or 47%, for the three months ended March 31, 2023 from the comparable period of 2022. The increase was primarily related to interest earned on bank deposits and to foreign currency exchange rate gains.
 
Liquidity and Capital Resources 
 
Since inception, we have not generated any revenue and have incurred significant operating losses and negative cash flows from our operations, resulting in an accumulated deficit at March 31, 2023 of $73.0 million. We have funded our operations to date primarily with proceeds from the sale of our ADSs, and, prior to the Merger, other equity securities. Cash in excess of immediate requirements is invested primarily in bank deposits with a view to liquidity and capital preservation.
 
On April 30, 2021, the Company entered into an At the Market Offering Agreement (the "ATM Agreement") with Cantor Fitzgerald & Co., ("Cantor"). Pursuant to the ATM Agreement, the Company may offer and sell, from time to time, its ADSs having an aggregate offering price of up to $75 million through Cantor or the ATM Agreement. From April 30, 2021, through December 31, 2022 the Company issued 699,806 ADSs at an average price of $22.75 per ADS under the ATM Agreement, resulting in gross proceeds of $15,917 thousand.

 

On April 25, 2022, the Company filed a prospectus supplement with the SEC for the issuance and sale of up to $18,125,000 of its ADSs in connection with the reactivation of the ATM Facility and pursuant to General Instruction I.B.6 of Form S-3, which, subject to certain exceptions, limits the amount of securities the Company is able to offer and sell under such registration statement to one-third of our unaffiliated public float. During the year ended December 31, 2022, the Company issued 130,505 ADSs at an average price of $2.11 per ADS under the ATM Agreement, resulting in gross proceeds of $275 thousand.

 
Developing product candidates, conducting clinical trials and commercializing products are expensive, and we will need to raise substantial additional funds to achieve our strategic objectives. We believe that our existing cash resources, including from the ADSs sold pursuant to the Sales Agreement, will be sufficient to fund our projected cash requirements through June 30, 2024. Nevertheless, we will require significant additional financing in the future to fund our operations, including if and when we progress into additional clinical trials, obtain regulatory approval for any of our product candidates and commercialize the same. We believe that we will need to raise significant additional funds before we have any cash flow from operations, if at all. Our future capital requirements will depend on many factors, including:
 
 

the progress and costs of our preclinical studies, clinical trials and other research and development activities;
     
 

the scope, prioritization and number of our clinical trials and other research and development programs;
     
 

the amount of revenues and contributions we receive under future licensing, development and commercialization arrangements with respect to our product candidates;
     
 

the costs of the development and expansion of our operational infrastructure;
     
 

the costs and timing of obtaining regulatory approval for our product candidates;
15

 
 

the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
     
 

the costs and timing of securing manufacturing arrangements for clinical or commercial production;
     
 

the costs of contracting with third parties to provide sales and marketing capabilities for us;
     
 

the costs of acquiring or undertaking development and commercialization efforts for any future products, product candidates or platforms;
     
 

the magnitude of our general and administrative expenses; and
     
 

any cost that we may incur under future in- and out-licensing arrangements relating to our product candidates.
 
We currently do not have any commitments for future external funding. In the future, we will need to raise additional funds, and we may decide to raise additional funds even before we need such funds if the conditions for raising capital are feasible. Until we can generate significant recurring revenues, we expect to satisfy our future cash needs through debt or equity financings, credit facilities or by out-licensing applications of our product candidates. The sale of equity or convertible debt securities may result in dilution to our existing shareholders. The incurrence of indebtedness would result in increased fixed obligations and could also subject us to covenants that restrict our operations. We cannot be certain that additional funding, whether through grants from the Israel Innovation Authority, financings, credit facilities or out-licensing arrangements, will be available to us on acceptable terms, if at all. If sufficient funds are not available, we may be required to delay, reduce the scope of or eliminate research or development plans for, or commercialization efforts with respect to, one or more applications of our product candidates, or obtain funds through arrangements with collaborators or others that may require us to relinquish rights to certain potential products that we might otherwise seek to develop or commercialize independently.
 
Cash Flows 
 
The table below shows a summary of our cash flow activities for the periods indicated:
 
 
 
Three months ended
             
 
 
March 31,
   
Change
 
 
 
2023
   
2022
    $    
%
 
 
 
(in thousands)
               
Net cash used in operating activities
 
$
(7,186
)
 
$
(3,711
)
 
$
(3,475
)
   
(94
)%
Net cash provided by investing activities
 
$
14,432
   
$
2,382
   
$
12,050
     
506
%
Net cash used in financing activities
   
-
   
$
-
           
$
-
%
Net increase (decrease) in cash, cash equivalents and restricted cash
 
$
7,246
   
$
(1,329
)
 
$
8,575
     
(645
)%
 
Operating activities 
 
Net cash used in operating activities increased by $3.5 million, or 94%, for the three months ended March 31, 2023, compared to the same period of 2022. The increase is primarily related to the increase in net loss of $3.6 million.
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Investing activities 
 
Net cash provided in investing activities for the three months ended March 31, 2023 increased by approximately $12 million, as compared to the same period of 2022. The increase is primarily related to withdrawal of bank deposits.
 
Contractual Commitments 
 
The Company’s contractual commitments are as follows at March 31, 2023 (in thousands):
 
Remainder of 2023
 
$
6,361
 
2024
   
1,676
 
2025
   
1,060
 
Total
 
$
9,097
 
 
Critical Accounting Estimates
 
The Company’s financial statements are prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). The preparation of the Company’s financial statements and related disclosures in accordance with GAAP requires it to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and the disclosure of contingent assets and liabilities in the Company’s financial statements. The Company bases its estimates on historical experience, known trends and events and various other factors that it believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different assumptions or conditions.
 
While the Company’s significant accounting policies are described in more detail in Note 2 to the Company’s consolidated financial statements included in our 2022 Annual Report, the Company believes that the following accounting estimates are those that include a higher degree of judgment or complexity and are reasonably likely to have a material impact on our financial condition or results of operations and are therefore considered critical accounting estimates.
 
Share-Based Compensation
 
We apply Accounting Standard Codification (ASC) 718-10, “Share-Based Payment,” which requires the measurement and recognition of compensation expenses for all share-based payment awards made to employees and directors, including employee options under the Company’s option plans based on estimated fair values.
 
ASC 718-10 requires that we estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The fair value of the award is recognized as an expense over the requisite service periods in the Company’s statements of comprehensive loss. The Company recognizes share-based award forfeitures as they occur, rather than estimate by applying a forfeiture rate.
 
In June 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting”, which simplifies the accounting for nonemployee share-based payment transactions by aligning the measurement and classification guidance, with certain exceptions, to that for share-based payment awards to employees. The amendments expand the scope of the accounting standard for share-based payment awards to include share-based payment awards granted to non-employees in exchange for goods or services used or consumed in an entity’s own operations and supersedes the guidance related to equity-based payments to non-employees. We adopted these amendments on January 1, 2019.
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We recognize compensation expenses for the fair value of non-employee awards over the requisite service period of each award.
 
We estimate the fair value of options granted as equity awards using a Black-Scholes options pricing model. The option-pricing model requires a number of assumptions, of which the most significant are share price, expected volatility and the expected option term (the time from the grant date until the options are exercised or expire). The Company determines the fair value per share of the underlying stock by taking into consideration its most recent sales of stock, as well as additional factors that the Company deems relevant. The Company’s board determined the fair value of ordinary shares based on valuations performed using the Option Pricing Method subject to relevant facts and circumstances. The Company has historically been a private company and lacks company-specific historical and implied volatility information of its stock. Expected volatility is estimated based on volatility of similar companies in the biotechnology sector. The Company has historically not paid dividends and has no foreseeable plans to issue dividends. The risk-free interest rate is based on the yield from governmental zero-coupon bonds with an equivalent term. The expected option term is calculated for options granted to employees and directors using the “simplified” method. Grants to non-employees are based on the contractual term. Changes in the determination of each of the inputs can affect the fair value of the options granted and the results of operations of the Company.
 
Recently-Issued Accounting Pronouncements 
 
Certain recently-issued accounting pronouncements are discussed in Note 2, Summary of Significant Accounting Policies, to the audited consolidated financial statements in our 2022 Annual Report.
 
Item 3. Quantitative and Qualitative Disclosures About Market Risk. 
 
We are an emerging growth company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and are not required to provide the information under this item.
 
Item 4. Controls and Procedures. 
 
Evaluation of Disclosure Controls and Procedures 
 
Disclosure controls and procedures are designed to ensure that information required to be disclosed by us in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
 
Under the supervision and with the participation of our management, including our principal executive officer and principal financial and accounting officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of March 31, 2023. Based on such evaluation, our principal executive officer and principal financial officer have concluded that that our disclosure controls and procedures were effective as of March 31, 2023.
 
Changes in Internal Control over Financial Reporting 
 
There have been no changes in our internal control over financial reporting that occurred during the last fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. – OTHER INFORMATION 
 
Item 1. Legal Proceedings 
 
From time to time, we may become involved in legal proceedings relating to claims arising from the ordinary course of business. Our management believes that there are currently no claims or actions pending against us, the ultimate disposition of which could have a material adverse effect on our results of operations, financial condition or cash flows.
 
Item 1A. Risk Factors 
 
There have been no material changes from the information set forth in “Item 1A. Risk Factors” in our 2022 Annual Report.
 
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds. 
 
None.
 
Item 3. Defaults Upon Senior Securities. 
 
Not applicable.
 
Item 4. Mine Safety Disclosures. 
 
Not applicable.
 
Item 5. Other Information. 
 
None.
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Item 6. Exhibits.
 
(a) The following documents are filed as exhibits to this Quarterly Report or incorporated by reference herein.
 
Exhibit
Number 
 
Description 
 
 
 
 
 
 
 
 
 
32.2**  
     
101. INS
 
 
Inline XBRL Instance Document
 
101. SCH
 
 
Inline XBRL Taxonomy Extension Schema Document
 
101. CAL
 
 
Inline XBRL Taxonomy Extension Calculation Linkbase Document
 
101. DEF
 
 
Inline XBRL Taxonomy Extension Definition Linkbase Document
 
101. LAB
 
 
Inline XBRL Taxonomy Extension Label Linkbase Document
 
101. PRE
 
 
Inline XBRL Taxonomy Extension Presentation Linkbase Document
 
104
 
 
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
 
*
 
 
Filed herewith.
 
**
 
Furnished herewith.
 
20

SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. 
 
 
CHEMOMAB THERAPEUTICS LTD.
 
 
Date: May 11, 2023
By:
/s/ Dale Pfost 
 
 
Name:
Dale Pfost
 
 
Title:
Chief Executive Officer
 
 
 
 
 
Date: May 11, 2023
By:
/s/ Donald Marvin 
 
 
Name:
Donald Marvin
 
 
Title:
Chief Financial Officer
 
 

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