UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

  

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 12, 2022

 

Chemomab Therapeutics Ltd.

(Exact name of Registrant as Specified in Its Charter)

 

State of Israel 001-38807
81-3676773
(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)

 

Kiryat Atidim, Building 7
 
Tel Aviv, Israel 6158002
(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: +972-77-331-0156

 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the 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 Depositary Shares.

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

 

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.  ☐




Item 2.02.    Results of Operations and Financial Condition.

On May 12, 2022, Chemomab Therapeutics Ltd. (the “Company”) issued a press release announcing its financial results for its first quarter ended March 31, 2022. A copy of the press release is furnished herewith as Exhibit 99.1 and incorporated herein by reference.
 
The information contained herein and in the accompanying exhibit are “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference in such filing.
 
Item 9.01 Financial Statements and Exhibits.
 
(d) Exhibits
 
Exhibit Number
 
Exhibit Description

104
 
Cover Page Interactive Data File (embedded within the Inline XBRL document)

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SIGNATURE
 
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 hereunto duly authorized.
 
 
CHEMOMAB THERAPEUTICS LTD.
 
 
 
 
 
Date: May 12, 2022
By:
/s/ Donald Marvin
 
 
 
Name: Donald Marvin
 
 
 
Title: Executive V.P., Chief Financial Officer and Chief Operating Officer
 

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Exhibit 99.1

Therapeutics Announces First Quarter 2022 Financial Results and Provides
Corporate Update

─Company to Host Conference Call for Investors Today, May 12 at 8:00 am ET

TEL AVIV, Israel, May 12, 2022 -- 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.

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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

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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
 

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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.

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