Chemomab Therapeutics Ltd. - Quarter Report: 2022 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
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)
|
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*
|
Large accelerated filer
|
☐
|
|
Accelerated filer
|
☐
|
Non-accelerated filer
|
☒
|
|
Smaller reporting company
|
☒
|
|
|
|
Emerging growth company
|
☒
|
1 | |
1 | |
13 | |
21 | |
22 | |
23 | |
23 | |
23 | |
23 | |
23 | |
23 | |
23 | |
24 | |
25 |
● | 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. |
3 | |
4 | |
5 - 6 | |
7 | |
8 - 12 |
2
June 30,
|
December 31,
|
||||||||||
Note
|
2022
|
2021
|
|||||||||
|
Unaudited
|
Audited
|
|||||||||
Assets
|
|||||||||||
Current assets
|
|||||||||||
Cash and cash equivalents
|
9,883
|
15,186
|
|||||||||
Short term bank deposits
|
41,841
|
45,975
|
|||||||||
Other receivables and prepaid expenses
|
3,106
|
1,527
|
|||||||||
Total current assets
|
54,830
|
62,688
|
|||||||||
Non-current assets
|
|||||||||||
Long term prepaid expenses
|
821
|
908
|
|||||||||
Property and equipment, net
|
355
|
357
|
|||||||||
Restricted cash
|
77
|
55
|
|||||||||
Operating lease right-of-use assets
|
295
|
345
|
|||||||||
Total non-current assets
|
1,548
|
1,665
|
|||||||||
Total assets
|
56,378
|
64,353
|
|||||||||
Current liabilities
|
|||||||||||
Trade payables
|
1,433
|
1,336
|
|||||||||
Accrued expenses
|
1,712
|
555
|
|||||||||
Employee and related expenses
|
1,117
|
653
|
|||||||||
Operating lease liabilities
|
132
|
106
|
|||||||||
Total current liabilities
|
4,394
|
2,650
|
|||||||||
Non-current liabilities
|
|||||||||||
Operating lease liabilities - long term
|
148
|
237
|
|||||||||
Total non-current liabilities
|
148
|
237
|
|||||||||
Commitments and contingent liabilities
|
|||||||||||
Total liabilities
|
4,542
|
2,887
|
|||||||||
Shareholders' equity
|
1
|
||||||||||
Ordinary shares no par value - Authorized: 650,000,000 shares as of June 30, 2022 and as of December 31, 2021;
|
- |
- |
|||||||||
Issued and outstanding: 228,633,120 ordinary shares as of June 30, 2022 and 228,090,300 as of December 31, 2021
|
-
|
-
|
|||||||||
Additional paid in capital
|
99,303
|
97,639
|
|||||||||
Accumulated deficit
|
(47,467
|
)
|
(36,173
|
)
|
|||||||
Total shareholders’ equity
|
51,836
|
61,466
|
|||||||||
Total liabilities and shareholders’ equity
|
56,378
|
64,353
|
Three months
|
Three months
|
Six months
|
Six months
|
||||||||||||||||
Ended
|
Ended
|
Ended
|
Ended
|
||||||||||||||||
June 30,
|
June 30,
|
June 30,
|
June 30,
|
||||||||||||||||
Note
|
2022
|
2021
|
2022
|
2021
|
|||||||||||||||
Operating expenses
|
|||||||||||||||||||
Research and development
|
2,914
|
1,307
|
5,659
|
2,464
|
|||||||||||||||
General and administrative
|
3,340
|
1,446
|
5,915
|
1,988
|
|||||||||||||||
Total operating expenses
|
6,254
|
2,753
|
11,574
|
4,452
|
|||||||||||||||
Financing expense, net
|
480
|
17
|
264
|
22
|
|||||||||||||||
Loss before taxes
|
6,734
|
2,770
|
11,838
|
4,474
|
|||||||||||||||
Taxes on income (benefit)
|
|
|
(544
|
)
|
-
|
(544
|
)
|
-
|
|||||||||||
Net loss for the period
|
6,190
|
2,770
|
11,294
|
4,474
|
|||||||||||||||
Basic and diluted loss per Ordinary Share (*) (**)
|
0.027
|
0.013
|
0.050
|
0.024
|
|||||||||||||||
Weighted average number of Ordinary Shares outstanding, basic, and diluted (*) (**)
|
228,173,276
|
216,266,993
|
228,132,249
|
186,840,022
|
Ordinary
Shares
|
Additional
paid in
capital
|
Accumulated
Deficit
|
Total
Shareholders’
equity
|
|||||||||||||||||
Number | USD | USD | USD | USD | ||||||||||||||||
For the six-month period ended on June 30, 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
|
||||||||||||||
Share-based compensation
|
-
|
-
|
761
|
-
|
761
|
|||||||||||||||
Exercise of options
|
542,820
|
-
|
29
|
-
|
29
|
|||||||||||||||
Net loss for the period
|
-
|
-
|
-
|
(6,190
|
)
|
(6,190
|
)
|
|||||||||||||
Balance as of June 30, 2022
|
228,633,120
|
-
|
99,303
|
(47,467
|
)
|
51,836
|
Ordinary
Shares (*)
|
Additional
paid in
capital
|
Accumulated
Deficit
|
Total
Shareholders’
equity
|
|||||||||||||||||
Number
|
USD
|
USD
|
USD | USD | ||||||||||||||||
For the six-month period ended on June 30, 2021
|
||||||||||||||||||||
Balance as of January 1, 2021 (*)
|
9,274,838
|
-
|
34,497
|
(23,695
|
)
|
10,802
|
||||||||||||||
Share-based compensation
|
-
|
-
|
43
|
-
|
43
|
|||||||||||||||
Effect of reverse capitalization transaction
|
152,299,702
|
-
|
2,476
|
-
|
2,476
|
|||||||||||||||
Issuance of shares and warrants, net of issuance costs
|
52,385,400
|
-
|
43,547
|
-
|
43,547
|
|||||||||||||||
Net loss for the period
|
-
|
-
|
-
|
(1,704
|
)
|
(1,704
|
)
|
|||||||||||||
Balance as of March 31, 2021
|
213,959,940
|
-
|
80,563
|
(25,399
|
)
|
55,164
|
||||||||||||||
Share-based compensation
|
-
|
-
|
527
|
-
|
527
|
|||||||||||||||
Issuance of shares, net of issuance costs
|
13,996,120
|
-
|
15,118
|
-
|
15,118
|
|||||||||||||||
Net loss for the period
|
-
|
-
|
-
|
(2,770
|
)
|
(2,770
|
)
|
|||||||||||||
Balance as of June 30, 2021
|
227,956,060
|
-
|
96,208
|
(28,169
|
)
|
68,039
|
Six months
ended
June 30,
2022
|
Six months
Ended
June 30,
2021
|
|||||||
Cash flows from operating activities
|
||||||||
Net loss for the period
|
(11,294
|
)
|
(4,474
|
)
|
||||
Adjustments for operating activities:
|
||||||||
Depreciation
|
27
|
14
|
||||||
Change in other receivables and prepaid expenses
|
(1,483
|
)
|
(2,529
|
)
|
||||
Change in operating lease liability
|
(15
|
)
|
-
|
|||||
Change in trade payables
|
97
|
312
|
||||||
Change in accrued expenses
|
1,157
|
(993
|
)
|
|||||
Change in employees and related expenses
|
464
|
200
|
||||||
Share-based compensation
|
1,635
|
570
|
||||||
1,882
|
(2,426
|
)
|
||||||
Net cash used in operating activities
|
(9,412
|
)
|
(6,900
|
)
|
||||
Cash flows from investing activities
|
||||||||
Increase in deposits
|
-
|
(21,500
|
)
|
|||||
Decrease in deposits
|
4,134
|
-
|
||||||
Sale of asset held for sale
|
-
|
1,000
|
||||||
Purchase of property and equipment
|
(25
|
)
|
(105
|
)
|
||||
Net cash provided by (used in) investing activities
|
4,109
|
(20,605
|
)
|
|||||
Cash flows from financing activities
|
||||||||
Cash acquired in reverse recapitalization
|
-
|
2,427
|
||||||
Exercise of options
|
22
|
-
|
||||||
Issuance of shares, net of issuance costs
|
-
|
15,243
|
||||||
Issuance of shares and warrants, net of issuance costs
|
-
|
43,557
|
||||||
Net cash provided by financing activities
|
22
|
61,227
|
||||||
Change in cash, cash equivalents and restricted cash
|
(5,281
|
)
|
33,722
|
|||||
Cash, cash equivalents and restricted cash at beginning of period
|
15,241
|
11,727
|
||||||
Cash, cash equivalents and restricted cash at end of period
|
9,960
|
45,449
|
||||||
Supplemental disclosure of non-cash investing and financing activities:
|
||||||||
Liabilities assumed, net of non-cash assets received in reverse merger
|
-
|
49
|
||||||
Receivable related to exercise of options
|
7
|
-
|
||||||
Accrued share issuance expenses
|
-
|
135
|
CHEMOMAB THERAPEUTICS LTD AND ITS SUBSIDIARIES
(FORMERLY ANCHIANO THERAPEUTICS LTD)
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.
|
On March 16, 2021, the Company, then known as Anchiano Therapeutics Ltd. (“Anchiano”), completed its merger with Chemomab Ltd., a privately-held Israeli limited company (“Chemomab Ltd.”). Pursuant to the Agreement and Plan of Merger (the “Merger Agreement”) dated as of December 14, 2020, by and among Anchiano, CMB Acquisition Ltd., an Israeli limited company and wholly-owned subsidiary of Anchiano (“Merger Sub”), and Chemomab Ltd., Merger Sub merged with and into Chemomab Ltd., with Chemomab Ltd. being the surviving entity and becoming a wholly owned subsidiary of Anchiano (the “Merger”). Upon consummation of the Merger, the Company changed its name from “Anchiano Therapeutics Ltd.” to “Chemomab Therapeutics Ltd.” and the business conducted by Chemomab Ltd. became primarily the business conducted by the Company. |
8
CHEMOMAB THERAPEUTICS LTD AND ITS SUBSIDIARIES
(FORMERLY ANCHIANO THERAPEUTICS LTD)
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
Note 1 - General. (Cont.)
The accompanying unaudited condensed consolidated financial statements and notes to the unaudited condensed consolidated financial statements give retroactive effect to the exchange ratio and the Reverse Split for all periods presented.
Cash and cash equivalents
|
$
|
2,427
|
||
Asset held for sale
|
1,000
|
|||
Prepaid and other assets
|
236
|
|||
Accrued liabilities
|
(1,187
|
)
|
||
Net acquired assets
|
$
|
2,476
|
C.
|
In connection with the Merger, on March 15, 2021, Anchiano entered into Securities Purchase Agreements with certain purchasers for the issuance and sale by Anchiano in a private placement (the “Private Placement”) of approximately $45.5 million of its ADSs and accompanying warrants to purchase ADSs. The warrants have an exercise price of approximately $17.35 per ADS, expire five years from the date of issuance, and if exercised in full, will provide additional proceeds to the Company of approximately $4.5 million. The Private Placement closed on March 22, 2021.
|
9
CHEMOMAB THERAPEUTICS LTD AND ITS SUBSIDIARIES
(FORMERLY ANCHIANO THERAPEUTICS LTD)
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
Note 1 - General. (Cont.)
D.
|
Pursuant to an Asset Purchase and Assignment Agreement dated as of March 16, 2021, as amended on March 31, 2021, between the Company’s wholly owned subsidiary, Anchiano Therapeutics, Inc., a Delaware corporation (“Anchiano Delaware”) and Kestrel Therapeutics, Inc., a Delaware corporation (“Kestrel”), Anchiano Delaware agreed to sell to Kestrel all of the its rights and obligations in its business to the extent related to the research, development and commercialization of the Compounds and Products (as such terms are defined in the Collaboration and License Agreement entered into as of September 13, 2019, by and between ADT Pharmaceuticals, LLC and Anchiano Delaware), also known as the pan-RAS and PDE10/β-catenin programs. In consideration of the sale and transfer of the Compounds and Products, Kestrel paid the Company a total of $1.0 million.
|
E.
|
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 $75.0 million through Cantor pursuant to the ATM Agreement. From April 30, 2021 through June 30, 2022, the Company sold 699,806 ADSs at an average price of $22.75 per ADS under the ATM Agreement, resulting in gross proceeds of approximately $15.9 million. The offer and sale of ADSs under the ATM Agreement has been registered under the Company’s effective registration statement on Form S-3 (File No. 333-255658), together with a prospectus forming a part thereof, filed with the SEC under the Securities Act of 1933, as amended (the “Securities Act”). Sales, if any, of ADS pursuant to the ATM Agreement may be made in any transactions that are deemed to be “at the market” offerings as defined in Rule 415(a)(4) under the Securities Act. The Company is not obligated to sell any ADSs under the ATM Agreement.
|
F.
|
Since January 2020, the COVID-19 outbreak has dramatically expanded into a worldwide pandemic creating macro-economic uncertainty and disruption in the business and financial markets. Many countries around the world, including Israel, have been taking measures designated to limit the continued spread of the Coronavirus, including the closure of workplaces, restricting travel, prohibiting assembling, closing international borders and quarantining populated areas. The Company's clinical trial sites have been affected by the COVID-19 pandemic, and as a result, commencement of the enrollment of Company’s clinical trials of CM-101 in PSC was delayed and the enrollment rate has been affected as well. As a result, the Company extended patients recruiting to additional territories with significant recruitment potential. In addition, after enrollment in these trials, patients may drop out of the Company's trials because of the COVID-19 possible implications.
|
10
CHEMOMAB THERAPEUTICS LTD AND ITS SUBSIDIARIES
(FORMERLY ANCHIANO THERAPEUTICS LTD)
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
Note 1 - General. (Cont.)
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 expects to receive the refund during the second half of 2022.
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 June 30, 2022, and its results of operations for the three and six months ended June 30, 2022, and 2021, changes in shareholders’ equity for the six months ended June 30, 2022 and 2021, and cash flows for the six months ended June 30, 2022 and 2021. The results of operations for the three and six months ended June 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022 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, 2021 filed with the SEC. The Company’s significant accounting policies are disclosed in the audited financial statements for the year ended December 31, 2021 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.
11
CHEMOMAB THERAPEUTICS LTD AND ITS SUBSIDIARIES
(FORMERLY ANCHIANO THERAPEUTICS LTD)
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
12
• | 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. |
Three months ended | ||||||||||||||||
June 30, | Increase/(decrease) | |||||||||||||||
2022 | 2021 | $ | % | |||||||||||||
(in thousands) | ||||||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 2,914 | $ | 1,307 | $ | 1,607 | 123 | % | ||||||||
General and administrative | 3,340 | 1,446 | 1,894 | 131 | % | |||||||||||
Operating loss | (6,254 | ) | (2,753 | ) | 3,501 | 127 | % | |||||||||
Financing expense, net | 480 | 17 | 463 | 2,724 | % | |||||||||||
Income Tax | (544 | ) | - | (544 | ) | 100 | % | |||||||||
Net loss | $ | (6,190 | ) | $ | (2,770 | ) | $ | (3,420 | ) | 123 | % |
Six months ended | ||||||||||||||||
June 30, | Increase/(decrease) | |||||||||||||||
2022 | 2021 | $ | % | |||||||||||||
(in thousands) | ||||||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 5,659 | $ | 2,464 | $ | 3,195 | 130 | % | ||||||||
General and administrative | 5,915 | 1,988 | 3,927 | 198 | % | |||||||||||
Operating loss | (11,574 | ) | (4,452 | ) | (7,122 | ) | 160 | % | ||||||||
Financing expense, net | 264 | 22 | 242 | 1,100 | % | |||||||||||
Income Tax (benefit) | (544 | ) | - | (544 | ) | 100 | % | |||||||||
Net loss | $ | (11,294 | ) | $ | (4,474 | ) | $ | (6,820 | ) | 152 | % |
• | 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; |
• | 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. |
Six months ended | ||||||||||||||||
June 30, | Increase/(decrease) | |||||||||||||||
2022 | 2021 | $ | % | |||||||||||||
(in thousands) | ||||||||||||||||
Net cash used in operating activities | $ | (9,412 | ) | $ | (6,900 | ) | $ | (2,512 | ) | 36 | % | |||||
Net cash provided by (used in) investing activities | 4,109 | (20,605 | ) | 24,714 | (120 | )% | ||||||||||
Net cash provided by financing activities | 22 | 61,227 | (61,205 | ) | (100 | )% | ||||||||||
Net increase (decrease) in cash, cash equivalents and restricted cash | $ | (5,281 | ) | $ | 33,722 | $ | (39,003 | ) | (116 | )% |
Remainder of 2022 | $ | 5,021 | ||||
2023 | 5,741 | |||||
2024 | 146 | |||||
2025-2027 | - | |||||
Total | $ | 10,908 |
Critical Accounting Policies
Exhibit Number | Description | |
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. |
CHEMOMAB THERAPEUTICS LTD. | ||
Date: August 12, 2022 | By: | /s/ Dale Pfost |
Name: | Dale Pfost | |
Title: | Chief Executive Officer | |
Date: August 12, 2022 | By: | /s/ Donald Marvin |
Name: | Donald Marvin | |
Title: | Chief Financial Officer |
25