Chemomab Therapeutics Ltd. - Quarter Report: 2022 September (Form 10-Q)
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
Israel
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81-3676773
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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Kiryat Atidim, Building 7
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Tel Aviv, Israel 6158002
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(Address of principal executive offices including zip code)
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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American Depositary Shares, each representing twenty (20)
ordinary shares, no par value per share
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CMMB
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Nasdaq Capital Market
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Ordinary shares, no par value per share
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n/a
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Nasdaq Capital Market*
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Large accelerated filer
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☐
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Accelerated filer
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☐
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Non-accelerated filer
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☒
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Smaller reporting company
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☒
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Emerging growth company
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☒
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1 | |
1 | |
13 | |
19 | |
19 | |
20 | |
20 | |
20 | |
20 | |
20 | |
20 | |
20 | |
21 | |
22 |
● | 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. |
Page | |
3 | |
4 | |
5-6 | |
7 | |
8-12 |
2
September 30,
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December 31,
|
||||||||||
Note
|
2022
|
2021
|
|||||||||
|
Unaudited
|
Audited
|
|||||||||
Assets
|
|||||||||||
Current assets
|
|||||||||||
Cash and cash equivalents
|
10,741
|
15,186
|
|||||||||
Short term bank deposits
|
35,725
|
45,975
|
|||||||||
Other receivables and prepaid expenses
|
2,259
|
1,527
|
|||||||||
Total current assets
|
48,725
|
62,688
|
|||||||||
Non-current assets
|
|||||||||||
Long term prepaid expenses
|
776
|
908
|
|||||||||
Property and equipment, net
|
380
|
357
|
|||||||||
Restricted cash
|
77
|
55
|
|||||||||
Operating lease right-of-use assets
|
261
|
345
|
|||||||||
Total non-current assets
|
1,494
|
1,665
|
|||||||||
Total assets
|
50,219
|
64,353
|
|||||||||
Current liabilities
|
|||||||||||
Trade payables
|
1,247
|
1,336
|
|||||||||
Accrued expenses
|
2,577
|
555
|
|||||||||
Employee and related expenses
|
1,527
|
653
|
|||||||||
Operating lease liabilities
|
126
|
106
|
|||||||||
Total current liabilities
|
5,477
|
2,650
|
|||||||||
Non-current liabilities
|
|||||||||||
Operating lease liabilities - long term
|
118
|
237
|
|||||||||
Total non-current liabilities
|
118
|
237
|
|||||||||
Commitments and contingent liabilities
|
|||||||||||
Total liabilities
|
5,595
|
2,887
|
|||||||||
Shareholders' equity
|
1
|
||||||||||
Ordinary shares no par value - Authorized: 650,000,000 shares as of September 30, 2022 and as of December 31, 2021;
|
-
|
-
|
|||||||||
Issued and outstanding: 229,015,402 ordinary shares as of September 30, 2022 and 228,090,300 as of December 31, 2021
|
-
|
-
|
|||||||||
Additional paid in capital
|
100,171
|
97,639
|
|||||||||
Accumulated deficit
|
(55,547
|
)
|
(36,173
|
)
|
|||||||
Total shareholders’ equity
|
44,624
|
61,466
|
|||||||||
Total liabilities and shareholders’ equity
|
50,219
|
|
64,353 |
Three months
|
Three months
|
Nine months
|
Nine months
|
|||||||||||||||||
Ended
|
Ended
|
Ended
|
Ended
|
|||||||||||||||||
September 30,
|
September 30,
|
September 30,
|
September 30,
|
|||||||||||||||||
Note
|
2022
|
2021
|
2022
|
2021
|
||||||||||||||||
Operating expenses
|
||||||||||||||||||||
Research and development
|
5,423
|
1,487
|
11,082
|
3,951
|
||||||||||||||||
General and administrative
|
2,894
|
1,404
|
8,809
|
3,392
|
||||||||||||||||
Total operating expenses
|
8,317
|
2,891
|
19,891
|
7,343
|
||||||||||||||||
Financing expense (income), net
|
(237
|
)
|
77
|
27
|
99
|
|||||||||||||||
Loss before taxes
|
8,080
|
2,968
|
19,918
|
7,442
|
||||||||||||||||
Taxes on income (benefit)
|
-
|
-
|
(544
|
)
|
-
|
|||||||||||||||
Net loss for the period
|
8,080
|
2,968
|
19,374
|
7,442
|
||||||||||||||||
Basic and diluted loss per Ordinary Share (*) (**)
|
0.035
|
0.013
|
0.085
|
0.038
|
||||||||||||||||
Weighted average number of Ordinary Shares outstanding, basic, and diluted (*) (**)
|
228,773,418
|
227,956,060
|
228,349,115
|
195,292,384
|
Ordinary
Shares
|
Additional
paid in
capital
|
Accumulated
Deficit
|
Total
Shareholders’
equity
|
|||||||||||||||||
Number | USD | USD | USD | USD | ||||||||||||||||
For the nine-month period ended on September 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
|
||||||||||||||
Share-based compensation
|
-
|
-
|
836
|
-
|
836
|
|||||||||||||||
Exercise of options
|
382,282
|
-
|
32
|
-
|
32
|
|||||||||||||||
Net loss for the period
|
-
|
-
|
-
|
(8,080
|
)
|
(8,080
|
)
|
|||||||||||||
Balance as of September 30, 2022
|
229,015,402
|
-
|
100,171
|
(55,547
|
)
|
44,624
|
Ordinary
Shares (*)
|
Additional
paid in
capital
|
Accumulated
Deficit
|
Total
Shareholders’
equity
|
|||||||||||||||||
Number
|
USD | USD | USD | USD | ||||||||||||||||
For the nine-month period ended on September 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
|
||||||||||||||
Share-based compensation
|
-
|
-
|
441
|
-
|
441
|
|||||||||||||||
Net loss for the period
|
-
|
-
|
-
|
(2,968
|
)
|
(2,968
|
)
|
|||||||||||||
Balance as of September 30, 2021
|
227,956,060
|
-
|
96,649
|
(31,137
|
)
|
65,512
|
Nine months
|
Nine months
|
|||||||
ended |
Ended
|
|||||||
September 30,
|
September 30,
|
|||||||
2022
|
2021
|
|||||||
Cash flows from operating activities
|
||||||||
Net loss for the period
|
(19,374
|
)
|
(7,442
|
)
|
||||
Adjustments for operating activities:
|
||||||||
Depreciation
|
44
|
23
|
||||||
Change in other receivables and prepaid expenses
|
(600
|
)
|
(2,145
|
)
|
||||
Change in operating lease liability
|
(15
|
)
|
-
|
|||||
Change in trade payables
|
(89
|
)
|
321
|
|||||
Change in accrued expenses
|
2,022
|
(1,261
|
)
|
|||||
Change in employees and related expenses
|
874
|
13
|
||||||
Share-based compensation
|
2,471
|
1,011
|
||||||
4,707
|
(2,038
|
)
|
||||||
Net cash used in operating activities
|
(14,667
|
)
|
(9,480
|
)
|
||||
Cash flows from investing activities
|
||||||||
Increase in deposits
|
-
|
(26,500
|
)
|
|||||
Decrease in deposits
|
10,250
|
-
|
||||||
Sale of asset held for sale
|
-
|
1,000
|
||||||
Purchase of property and equipment
|
(67
|
)
|
(105
|
)
|
||||
Net cash provided by (used in) investing activities
|
10,183
|
(25,605
|
)
|
|||||
Cash flows from financing activities
|
||||||||
Cash acquired in reverse recapitalization
|
-
|
2,427
|
||||||
Exercise of options
|
61
|
-
|
||||||
Issuance of shares, net of issuance costs
|
-
|
15,181
|
||||||
Issuance of shares and warrants, net of issuance costs
|
-
|
43,547
|
||||||
Net cash provided by financing activities
|
61
|
61,155
|
||||||
Change in cash, cash equivalents and restricted cash
|
(4,423
|
)
|
26,070
|
|||||
Cash, cash equivalents and restricted cash at beginning of period
|
15,241
|
11,727
|
||||||
Cash, cash equivalents and restricted cash at end of period
|
10,818
|
37,797
|
||||||
Supplemental disclosure of non-cash investing and financing activities:
|
||||||||
Liabilities assumed, net of non-cash assets received in reverse merger
|
-
|
49
|
||||||
Accrued share issuance expenses
|
-
|
63
|
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.)
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
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 September 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.
Based on management’s assessment, the extent to which the coronavirus will further impact the Company’s operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the outbreak, and the actions that may be required to contain the coronavirus or treat its impact. The Company is carefully monitoring the restrictions due to the COVID-19 outbreak and will adjust activities accordingly.
|
10
CHEMOMAB THERAPEUTICS LTD AND ITS SUBSIDIARIES
(FORMERLY ANCHIANO THERAPEUTICS LTD)
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
A.
|
Basis of Preparation
|
B.
|
Use of estimates
|
11
CHEMOMAB THERAPEUTICS LTD AND ITS SUBSIDIARIES
(FORMERLY ANCHIANO THERAPEUTICS LTD)
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
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 failure. Excessive 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.
• | 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 | ||||||||||||||||
September 30, | Increase/(decrease) | |||||||||||||||
2022 | 2021 | $ | % | |||||||||||||
(in thousands) | ||||||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 5,423 | $ | 1,487 | $ | 3,936 | 265 | % | ||||||||
General and administrative | 2,894 | 1,404 | 1,490 | 106 | % | |||||||||||
Operating loss | 8,317 | 2,891 | 5,426 | 188 | % | |||||||||||
Financing expense (income), net | (237 | ) | 77 | (314 | ) | (408 | )% | |||||||||
Net loss | $ | 8,080 | $ | 2,968 | $ | 5,112 | 172 | % |
Nine months ended | |||||||||||||||
September 30, | Increase/(decrease) | ||||||||||||||
2022 | 2021 | $ | % | ||||||||||||
(in thousands) | |||||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 11,082 | $ | 3,951 | $ | 7,131 | 180 | ||||||||
General and administrative | 8,809 | 3,392 | 5,417 | 160 | |||||||||||
Operating loss | 19,891 | 7,343 | 12,548 | 171 | |||||||||||
Financing expense, net | 27 | 99 | (72) | (73) | |||||||||||
Income Tax (benefit) | (544) | - | (544) | (100) | |||||||||||
Net loss | $ | 19,374 | $ | 7,442 | $ | 11,932 | 160 |
• | 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. |
Nine months ended | ||||||||||||||||
September 30, | Increase/(decrease) | |||||||||||||||
2022 | 2021 | $ | % | |||||||||||||
(in thousands) | ||||||||||||||||
Net cash used in operating activities | $ | (14,667 | ) | $ | (9,480 | ) | $ | (5,187 | ) | 55 | % | |||||
Net cash provided by (used in) investing activities | 10,183 | (25,605 | ) | 35,788 | (140 | )% | ||||||||||
Net cash provided by financing activities | 61 | 61,155 | (61,094 | ) | (99 | )% | ||||||||||
Net increase (decrease) in cash, cash equivalents and restricted cash | $ | (4,423 | ) | $ | 26,070 | $ | (30,493 | ) | (117 | )% |
Remainder of 2022 | $ | 1,860 | |||
2023 | 6,878 | ||||
2024 | 634 | ||||
2025-2027 | 159 | ||||
Total | $ | 9,531 |
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. | |
** | The certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing. |
CHEMOMAB THERAPEUTICS LTD. | ||
Date: November 10, 2022 | By: | /s/ Dale Pfost |
Name: | Dale Pfost | |
Title: | Chief Executive Officer | |
Date: November 10, 2022 | By: | /s/ Donald Marvin |
Name: | Donald Marvin | |
Title: | Chief Financial Officer |