UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16
Under the Securities Exchange Act of 1934
For the Month of August 2023
Commission File Number: 001-41084
NeuroSense Therapeutics Ltd.
(Translation of registrant’s name into English)
11 HaMenofim Street, Building B
Herzliya 4672562 Israel
+972-9-799-6183
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
On August 16, 2023, NeuroSense Therapeutics Ltd. (the “Company”) issued a press release announcing the Company’s financial results for the second quarter ended June 30, 2023. A copy of the press release is furnished herewith as Exhibit 99.1.
In addition, attached are the Company’s condensed interim unaudited financial statements and a summary of its operating and financial review and prospects, each as of June 30, 2023, furnished herewith as Exhibits 99.2 and 99.3, respectively.
This Report on Form 6-K (including the text under the headings “Financial Summary” and “Forward-Looking Statements” in Exhibit 99.1, Exhibit 99.2 and Exhibit 99.3) is hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File No. 333-262480) and Form F-1 (File No. 333-273375), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit Index
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.
NeuroSense Therapeutics Ltd. | ||
Date: August 16, 2023 | By: | /s/ Alon Ben-Noon |
Alon Ben-Noon | ||
Chief Executive Officer |
2
Exhibit 99.1
NeuroSense Announces Second Quarter 2023 Financial Results and Provides Business Update
● | ALS Phase 2b PARADIGM Trial Completed Patient Enrollment |
● | Topline results expected in Q-4 2023 |
● | Cash runway beyond topline clinical study readouts, into Q-2 2024 |
CAMBRIDGE, Mass., Aug. 16, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a company developing treatments for severe neurodegenerative diseases, today published its financial results for the quarter ended June 30, 2023 and provided a business update.
“Throughout this quarter NeuroSense achieved multiple milestones, including the completion of patient enrollment of our Phase 2b ALS study. Results observed from several biomarker studies are promising, especially in that they support our clinical strategy. The findings, along with the data we collect from our Phase 2b study, could inform the optimization of a pivotal Phase 3 study of PrimeC in ALS,” stated NeuroSense’s CEO, Alon Ben-Noon. “We are well positioned to complete our Phase 2b study and report topline results in Q-4 2023.”
Business Update
Capital Raise of $4.5 Million
In Q-2 2023, NeuroSense raised $4.5 million in capital and based on our current expense projections is now funded into Q-2 2024, well beyond the expected timing for the release of topline results from the PARADIGM study.
Phase 2b Amyotrophic Lateral Sclerosis (ALS) PARADIGM Trial Completed Patient Enrollment
In Q-2 2023, NeuroSense completed enrollment of its double-blind, placebo-controlled, multi-center Phase 2b clinical trial using a unique upgraded formulation of PrimeC, which is designed to maximize the synergistic effect between the compounds in its combination drug. The clinical trial endpoints include assessment of ALS biomarkers, evaluation of clinical efficacy, and improvement in quality of life to demonstrate an attenuation in disease progression. Elucidation of the mechanism of action of PrimeC utilizing data from the upcoming Phase 2b trial may enable patient stratification and increase the likelihood of success in a pivotal trial. Topline results are expected in Q-4 2023. Significantly, over 96% of participants who completed the trial chose to continue in the study and be treated with PrimeC through a 12-month open-label extension.
Strategic Scientific Agreement with Biogen
In May 2023, NeuroSense announced a collaboration agreement with Biogen to evaluate the impact of PrimeC on neurofilament levels in the plasma of participants in NeuroSense’s Phase 2b ALS PARADIGM trial. Biogen will fund this meaningful neurofilament biomarker study and upon receipt of results has the right of first refusal to co-develop and/or commercialize PrimeC for the treatment of ALS for a limited time.
Phase 2 Alzheimer’s Disease (AD) Trial Under Preparation
In Q-1 2023, NeuroSense published data from a biomarker study, which revealed elevated levels of novel biomarker TDP-43 in AD as compared to healthy controls. NeuroSense believes these results support the therapeutic potential of its combination drug platform for AD. NeuroSense is preparing to commence a Phase 2 double-blind proof-of-concept clinical study, with regulatory submissions and site readiness ongoing during Q-2 2023 and first patient enrolled expected in the next few weeks.
Parkinson’s Disease (PD) Biomarker Study Completed
In Q-2 2023, NeuroSense published data from a biomarker study in Parkinson’s disease, which observed a statistically significant decrease in levels of AGO2, a novel PD biomarker, in newly diagnosed PD patients when compared to the healthy control group. The Company is exploring potential co-development for the PD indication.
Key Industry Conferences
In addition, NeuroSense joined EverythingALS in the EverythingALS Digital Biomarkers Summit in July 2023.
Financial Summary
Six Months Ended June 30, 2023
● | Research and development expenses for the six months ended June 30, 2023 increased to $4.0 million compared to $3.17 million for the six months ended June 30, 2022. This increase was primarily attributable to subcontractors and consultants with respect to our Phase 2b clinical study that started in May 2022. NeuroSense expects research and development expenses to remain steady until the end of 2023, and then slightly decrease as a result of completing the double blind stage of the clinical study. |
● | General and administrative expenses for the six months ended June 30, 2023 decreased to $3.11 million compared to $3.69 million for the six months ended June 30, 2022. This decrease was primarily attributable to lower share-based compensation and insurance expenses. NeuroSense expects that general and administrative expenses will remain at the same level through 2023. |
● | Financing expenses for the six months ended June 30, 2023 and 2022, were $2.2 million and $58,000, respectively. The increase of $2.14 million, or 3,686%, was mainly attributed to liability with respect to warrants and prefunded warrants. |
● | Financing income for the six months ended June 30, 2023 and 2022 were $200,000 and $716,000, respectively. The decrease of $516,000, or 72%, was mainly attributed to change in rate differentials and warrants. |
● | Operating expenses for the six months ended June 30, 2023 were $7.12 million compared to $6.85 million for the six months ended June 30, 2022 due to the reasons described above. |
As of June 30, 2023, NeuroSense had cash and short-term deposits of $7.1 million. NeuroSense reported a $1.55 million deficit in shareholder equity as of June 30, 2023, resulting from the required accounting treatment under IFRS related to the pre-funded warrants and warrants that the Company issued as part of the $4.5 million financing completed on June 26, 2023. A summary of the Company’s unaudited financial results is included in the tables below.
Condensed Interim Unaudited Statements of Financial Position
U.S. dollars in thousands
June 30, 2023 |
December 31, 2022 |
|||||||
Assets | ||||||||
Current assets: | ||||||||
Cash | 7,089 | 3,543 | ||||||
Short term deposits | - | 3,547 | ||||||
Other receivables | 434 | 255 | ||||||
Restricted deposit | 38 | 36 | ||||||
Total current assets | 7,561 | 7,381 | ||||||
Non-current assets: | ||||||||
Property, plant and equipment, net | 93 | 77 | ||||||
Right of use assets | 191 | 229 | ||||||
Non-current restricted deposit | 23 | 23 | ||||||
Total non-current assets | 307 | 329 | ||||||
Total assets | 7,868 | 7,710 | ||||||
Liabilities and Equity | ||||||||
Current liabilities: | ||||||||
Trade payables | 1,090 | 498 | ||||||
Other payables | 1,915 | 1,228 | ||||||
Total current liabilities | 3,005 | 1,726 | ||||||
Non Current liabilities: | ||||||||
Long term lease liability | 104 | 147 | ||||||
Liability in respect of warrants and pre-funded warrants | 6,304 | 218 | ||||||
6,408 | 365 | |||||||
Total liabilities | 9,413 | 2,091 | ||||||
Shareholders’ equity: | ||||||||
Ordinary shares | - | - | ||||||
Share premium and capital reserve | 28,355 | 26,405 | ||||||
Accumulated deficit | (29,900 | ) | (20,786 | ) | ||||
Total Shareholders’ equity (deficit) | (1,545 | ) | 5,619 | |||||
Total liabilities and shareholders’ equity (deficit) | 7,868 | 7,710 |
Condensed Interim Unaudited Statements of Income and Comprehensive
Loss
U.S. dollars in thousands except share and per share data
Six months ended June 30, 2023 |
Six months ended June 30, 2022 |
For the year ended December 31, 2022 |
||||||||||
Research and development expenses | (4,005 | ) | (3,166 | ) | (6,416 | ) | ||||||
General and administrative expenses | (3,113 | ) | (3,688 | ) | (7,136 | ) | ||||||
Operating loss | (7,118 | ) | (6,854 | ) | (13,552 | ) | ||||||
Financing expenses | (2,196 | ) | (58 | ) | (45 | ) | ||||||
Financing income | 200 | 716 | 1,257 | |||||||||
Financing income (expenses), net | (1,996 | ) | 658 | 1,212 | ||||||||
Net loss and comprehensive loss | (9,114 | ) | (6,196 | ) | (12,340 | ) | ||||||
Basic and diluted net loss per share | (0.77 | ) | (0.55 | ) | (1.07 | ) | ||||||
Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 13,623,042 | 11,294,701 | 11,504,521 |
Condensed Interim Unaudited Statements of Changes in Equity
U.S. dollars in thousands
Ordinary Shares |
Share Capital Reserve |
Accumulated Deficit |
Total Equity (Deficit) |
|||||||||||||
Six months ended June 30, 2023: | ||||||||||||||||
Balance as at January 1, 2023 | - | 26,405 | (20,786 | ) | 5,619 | |||||||||||
Share-based compensation | - | 1,945 | - | 1,945 | ||||||||||||
Exercise of options | - | 5 | - | 5 | ||||||||||||
Net loss and comprehensive loss | - | - | (9,114 | ) | (9,114 | ) | ||||||||||
Balance as at June 30, 2023 | - | 28,355 | (29,900 | ) | (1,545 | ) | ||||||||||
Six months ended June 30, 2022: | ||||||||||||||||
Balance as at January 1, 2022 | - | 17,452 | (8,446 | ) | 9,006 | |||||||||||
Share-based compensation | - | 2,808 | - | 2,808 | ||||||||||||
Net loss and comprehensive loss | - | - | (6,196 | ) | (6,196 | ) | ||||||||||
Cancelation of options | (96 | ) | - | (96 | ) | |||||||||||
Exercise of warrants | - | 4,314 | - | 4,314 | ||||||||||||
Balance as at June 30, 2022 | - | 24,478 | (14,642 | ) | 9,836 | |||||||||||
For the year ended December 31, 2022: | ||||||||||||||||
Balance as at January 1, 2022 | - | 17,452 | (8,446 | ) | 9,006 | |||||||||||
Share-based compensation | - | 4,735 | - | 4,735 | ||||||||||||
Net loss and comprehensive loss | - | - | (12,340 | ) | (12,340 | ) | ||||||||||
Cancelation of options | - | (96 | ) | - | (96 | ) | ||||||||||
Exercise of warrants | - | 4,314 | - | 4,314 | ||||||||||||
Balance as at December 31, 2022 | - | 26,405 | (20,786 | ) | 5,619 |
Condensed Interim Unaudited Statements of Cash Flows
U.S. dollars in thousands
Six months ended June 30, 2023 |
Six months ended June 30, 2022 |
For
the year ended December 31, 2022 |
||||||||||
Cash flows from operating activities | ||||||||||||
Net loss for the period | (9,114 | ) | (6,196 | ) | (12,340 | ) | ||||||
Adjustments: | ||||||||||||
Depreciation and Amortization | 47 | 41 | 89 | |||||||||
Share-based compensation | 1,784 | 2,808 | 5,105 | |||||||||
Revaluation of liability in respect to warrants and pre-funded warrants | (73 | ) | (693 | ) | (1,166 | ) | ||||||
Loss from financial instruments issuance as of the date of issuance | 1,659 | |||||||||||
Finance expenses (income), net | 365 | 65 | (24 | ) | ||||||||
Changes in assets and liabilities: | ||||||||||||
Decrease (increase) in other receivables | (179 | ) | (397 | ) | 55 | |||||||
Increase in trade payables | 592 | 81 | 459 | |||||||||
Increase in other payables | 841 | 5 | 236 | |||||||||
Net cash used in operating activities | (4,078 | ) | (4,286 | ) | (7,586 | ) | ||||||
Cash flows from investing activities | ||||||||||||
Interest received | 47 | - | 49 | |||||||||
Change in short term deposit | 3,500 | (6,000 | ) | (3,500 | ) | |||||||
Investment in restricted deposit | (2 | ) | (19 | ) | (20 | ) | ||||||
Purchase of property, plant and equipment | (25 | ) | (30 | ) | (70 | ) | ||||||
Net cash provided by (used in) investing activities | 3,520 | (6,049 | ) | (3,541 | ) | |||||||
Cash flows from financing activities | ||||||||||||
Payment in respect of cancellation of options | - | (96 | ) | (96 | ) | |||||||
Exercise of warrants and options | 5 | 3,870 | 3,870 | |||||||||
Issuance of shares, warrants and pre-funded warrants, net | 4,142 | - | - | |||||||||
Repayment of lease liability | (44 | ) | (67 | ) | (79 | ) | ||||||
Net cash provided by financing activities | 4,103 | 3,707 | 3,695 | |||||||||
Effects of exchange rate changes on cash and cash equivalents | 1 | (86 | ) | (88 | ) | |||||||
Net increase (decrease) in cash and cash equivalents | 3,546 | (6,714 | ) | (7,520 | ) | |||||||
Cash and cash equivalents at beginning of the period | 3,543 | 11,063 | 11,063 | |||||||||
Cash and cash equivalents at end of the period | 7,089 | 4,349 | 3,543 |
About NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
For additional information, we invite you to visit our website and follow us on LinkedIn and Twitter.
Forward-Looking Statements
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of top-line results of, and the results of, the PARADIGM clinical trial, cash runway estimate and the timing of patient enrollment in our Alzheimer’s Disease (AD) clinical trial. Further, forward-looking statements are subject to a number of risks and uncertainties as a result of which actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include a delay in the reporting of top-line results from PARADIGM clinical trial and a delay in patient enrollment in our AZ clinical trial; greater than anticipated costs and expenses; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the timing of current and future clinical trials, timing for reporting data; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC), including NeuroSense’s Annual Report on Form 20-F filed with the SEC on March 22, 2023. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense Therapeutics Ltd. undertakes no duty to update such information except as required under applicable law.
Logo - https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg
For further information: Email: info@neurosense-tx.com, Tel: +972 (0)9 799 6183
7
Exhibit 99.2
NeuroSense Therapeutics Ltd.
Condensed Interim Unaudited Statements of Financial Position
U.S. dollars in thousands
June 30, | December 31, | |||||||
2023 | 2022 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash | 7,089 | 3,543 | ||||||
Short term deposits | 3,547 | |||||||
Other receivables | 434 | 255 | ||||||
Restricted deposit | 38 | 36 | ||||||
Total current assets | 7,561 | 7,381 | ||||||
Non-current assets: | ||||||||
Property, plant and equipment, net | 93 | 77 | ||||||
Right of use assets | 191 | 229 | ||||||
Non-current restricted deposit | 23 | 23 | ||||||
Total non-current assets | 307 | 329 | ||||||
Total assets | 7,868 | 7,710 | ||||||
Liabilities and Equity | ||||||||
Current liabilities: | ||||||||
Trade payables | 1,090 | 498 | ||||||
Other payables | 1,915 | 1,228 | ||||||
Total current liabilities | 3,005 | 1,726 | ||||||
Non Current liabilities: | ||||||||
Long term lease liability | 104 | 147 | ||||||
Liability in respect of warrants and pre-funded warrants | 6,304 | 218 | ||||||
6,408 | 365 | |||||||
Total liabilities | 9,413 | 2,091 | ||||||
Shareholders’ equity: | ||||||||
Ordinary shares | ||||||||
Share premium and capital reserve | 28,355 | 26,405 | ||||||
Accumulated deficit | (29,900 | ) | (20,786 | ) | ||||
Total Shareholders’ equity (deficit) | (1,545 | ) | 5,619 | |||||
Total liabilities and shareholders’ equity (deficit) | 7,868 | 7,710 |
Date of approval of the interim financial statements: August 15, 2023
Mark Leuchtenberger | Alon Ben-Noon | Or Eisenberg | ||
Chairman of the Board of Directors | Chief Executive Officer | Chief Executive Officer |
The accompanying notes are an integral part of the condensed interim financial statements.
NeuroSense Therapeutics Ltd.
Condensed Interim Unaudited Statements of Income and Comprehensive Loss
U.S. dollars in thousands except share and per share data
Six months | Six months | For the year | |||||||||||||
ended | ended | ended | |||||||||||||
June 30, | June 30, | December 31, | |||||||||||||
Note | 2023 | 2022 | 2022 | ||||||||||||
Research and development expenses | 7 | (4,005 | ) | (3,166 | ) | (6,416 | ) | ||||||||
General and administrative expenses | 8 | (3,113 | ) | (3,688 | ) | (7,136 | ) | ||||||||
Operating loss | (7,118 | ) | (6,854 | ) | (13,552 | ) | |||||||||
Financing expenses | (2,196 | ) | (58 | ) | (45 | ) | |||||||||
Financing income | 200 | 716 | 1,257 | ||||||||||||
Financing income (expenses), net | 9 | (1,996 | ) | 658 | 1,212 | ||||||||||
Net loss and comprehensive loss | (9,114 | ) | (6,196 | ) | (12,340 | ) | |||||||||
(0.77 | ) | (0.55 | ) | (1.07 | ) | ||||||||||
13,623,042 | 11,294,701 | 11,504,521 |
The accompanying notes are an integral part of the condensed interim financial statements.
NeuroSense Therapeutics Ltd.
Condensed Interim Unaudited Statements of Changes in Equity
U.S. dollars in thousands
Ordinary | Share Premium And Capital |
Accumulated | Total Equity |
|||||||||||||
Shares | Reserve | Deficit | (Deficit) | |||||||||||||
Six months ended June 30, 2023: | ||||||||||||||||
Balance as at January 1, 2023 | 26,405 | (20,786 | ) | 5,619 | ||||||||||||
Share-based compensation | 1,945 | 1,945 | ||||||||||||||
Exercise of options | 5 | 5 | ||||||||||||||
Net loss and comprehensive loss | (9,114 | ) | (9,114 | ) | ||||||||||||
Balance as at June 30, 2023 | 28,355 | (29,900 | ) | (1,545 | ) | |||||||||||
Six months ended June 30, 2022: | ||||||||||||||||
Balance as at January 1, 2022 | 17,452 | (8,446 | ) | 9,006 | ||||||||||||
Share-based compensation | 2,808 | 2,808 | ||||||||||||||
Net loss and comprehensive loss | (6,196 | ) | (6,196 | ) | ||||||||||||
Cancelation of options | (96 | ) | (96 | ) | ||||||||||||
Exercise of warrants | 4,314 | 4,314 | ||||||||||||||
Balance as at June 30, 2022 | 24,478 | (14,642 | ) | 9,836 | ||||||||||||
For the year ended December 31, 2022: | ||||||||||||||||
Balance as at January 1, 2022 | 17,452 | (8,446 | ) | 9,006 | ||||||||||||
Share-based compensation | 4,735 | 4,735 | ||||||||||||||
Net loss and comprehensive loss | (12,340 | ) | (12,340 | ) | ||||||||||||
Cancelation of options | (96 | ) | (96 | ) | ||||||||||||
Exercise of warrants | 4,314 | 4,314 | ||||||||||||||
Balance as at December 31, 2022 | 26,405 | (20,786 | ) | 5,619 |
The accompanying notes are an integral part of the condensed interim financial statements.
NeuroSense Therapeutics Ltd.
Condensed Interim Unaudited Statements of Cash Flows
U.S. dollars in thousands
Six months | Six months | For the year | ||||||||||
ended | ended | ended | ||||||||||
June 30, | June 30, | December 31, | ||||||||||
2023 | 2022 | 2022 | ||||||||||
Cash flows from operating activities | ||||||||||||
Net loss for the period | (9,114 | ) | (6,196 | ) | (12,340 | ) | ||||||
Adjustments: | ||||||||||||
Depreciation and Amortization | 47 | 41 | 89 | |||||||||
Share-based compensation | 1,784 | 2,808 | 5,105 | |||||||||
Revaluation of liability in respect to warrants and pre-funded warrants | (73 | ) | (693 | ) | (1,166 | ) | ||||||
Day 1 loss from issuance of financial instruments | 1,659 | |||||||||||
Finance expenses (income), net | 365 | 65 | (24 | ) | ||||||||
Changes in assets and liabilities: | ||||||||||||
Decrease (increase) in other receivables | (179 | ) | (397 | ) | 55 | |||||||
Increase in trade payables | 592 | 81 | 459 | |||||||||
Increase in other payables | 841 | 5 | 236 | |||||||||
Net cash used in operating activities | (4,078 | ) | (4,286 | ) | (7,586 | ) | ||||||
Cash flows from investing activities | ||||||||||||
Interest received | 47 | 49 | ||||||||||
Change in short term deposit | 3,500 | (6,000 | ) | (3,500 | ) | |||||||
Investment in restricted deposit | (2 | ) | (19 | ) | (20 | ) | ||||||
Purchase of property, plant and equipment | (25 | ) | (30 | ) | (70 | ) | ||||||
Net cash provided by (used in) investing activities | 3,520 | (6,049 | ) | (3,541 | ) | |||||||
Cash flows from financing activities | ||||||||||||
Payment in respect of cancellation of options | (96 | ) | (96 | ) | ||||||||
Exercise of warrants and options | 5 | 3,870 | 3,870 | |||||||||
Issuance of shares, warrants and pre-funded warrants, net | 4,142 | |||||||||||
Repayment of lease liability | (44 | ) | (67 | ) | (79 | ) | ||||||
Net cash provided by financing activities | 4,103 | 3,707 | 3,695 | |||||||||
Effects of exchange rate changes on cash and cash equivalents | 1 | (86 | ) | (88 | ) | |||||||
Net increase (decrease) in cash and cash equivalents | 3,546 | (6,714 | ) | (7,520 | ) | |||||||
Cash and cash equivalents at beginning of the period | 3,543 | 11,063 | 11,063 | |||||||||
Cash and cash equivalents at end of the period | 7,089 | 4,349 | 3,543 | |||||||||
Non-cash activity | ||||||||||||
Exercise of warrants | 444 | 444 | ||||||||||
Recognition of right of use assets | 306 | 306 | ||||||||||
Share based payment modification | 161 |
The accompanying notes are an integral part of the condensed interim financial statements.
NeuroSense Therapeutics Ltd.
Notes to the Condensed Interim Financial Statements as at June 30, 2023
Note 1 - General and Basis for Presentation
Note 1 — General
A. | NeuroSense Therapeutics Ltd. (“NeuroSense” or the “Company”) was incorporated in Israel on February 13, 2017. NeuroSense is a clinical-stage pharmaceutical company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. The Company’s lead product candidate, PrimeC, is a novel oral formulation of a fixed dose combination composed of a specific ratio and doses of two FDA-approved drugs. |
In addition to PrimeC, the Company has initiated research and development efforts in Alzheimer’s disease and Parkinson’s disease, with a similar strategy of combined products.
The Company’s ordinary shares and warrants began trading on the Nasdaq Capital Market on December 9, 2021 under the ticker symbols “NRSN” and “NRSNW,” respectively.
B. | The Company currently has no products approved for sale, and the Company’s operations have been funded primarily by its shareholders. To date, the Company has generated no sales or revenues, has incurred losses and expects to incur significant additional losses due to the continuing focus on the research, development, clinical activities of its product candidates, preclinical programs, business development, organizational structure and to advance the programs within the Company’s pipeline. Consequently, its operations are subject to all the risks inherent in the establishment of a pre-revenue business enterprise as well as those risks associated with a company engaged in the research and development of pharmaceutical compounds. |
Based on current expected level of operating expenditures, the Company’s cash resources as at June 30, 2023 shall not be sufficient to fund the Company’s operations for a period of at least 12 months from the approval of these interim consolidated financial statements, assuming that the Company will continue its development plan in accordance with the original pipeline and without delaying or slowing down the progress of its plans. The Company will require additional cash to fund the execution of its mid-term and long-term development program. The Company anticipates raising additional funds through public or private sales of debt or equity securities, collaborative arrangements, or some combination thereof. Whilst management is progressing with its plans to secure external financing, these still require approval by third parties, and accordingly, there is no assurance that any such arrangement will be entered into or that financing will be available when needed in order to allow it to continue its operations, or if available, on terms favorable or acceptable to it.
In the event financing is not obtained, the Company may pursue cost cutting measures or may be required to delay, reduce the scope of, or eliminate any of its development programs or clinical trials, these events could have a material adverse effect on its business. These factors raise significant doubt about the Company ability to continue as a going concern. The consolidated financial statements do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
NeuroSense Therapeutics Ltd.
Notes to the Condensed Interim Financial Statements as at June 30, 2023
Note 2 — Basis of Preparation
A. | Statement of compliance |
These condensed interim financial statements have been prepared in accordance with International Accounting Standards (“IAS”) 34 “Interim Financial Reporting”. The condensed interim financial statements do not include all of the information required for full annual financial statements and should be read in conjunction with the Company’s financial statements for the year ended December 31, 2022 (“annual financial statements”).
These condensed interim financial statements were authorized for issuance by the Company’s Board of Directors on August 15, 2023.
B. | Use of estimates and judgments |
The preparation of interim financial statements in accordance to IFRS requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets and liabilities, income and expense. Actual results may differ from these estimates.
In preparing these condensed consolidated interim financial statements, the significant judgments made by management in applying the Company’s accounting policies and the key sources of estimation uncertainty were the same as those that applied to the annual financial statements except for the described below:
Fair value measurement of liability in respect of Warrants
Warrants that provide the holders with an option for cashless exercise are considered a derivative liability and are classified as financial liabilities at fair value through profit or loss. Accordingly, these warrants are measured at fair value and the changes in fair value in each reporting period are recognized in profit or loss.. The fair values of these instruments are determined by using the Black-Scholes model.
For information on details regarding fair value measurement at Level 2 see Note 4.
Note 3 — Significant Accounting Policies
The accounting policies applied by the Company in these condensed interim financial statements are the same as those applied by the Company in its annual financial statements.
NeuroSense Therapeutics Ltd.
Notes to the Condensed Interim Financial Statements as at June 30, 2023
Note 4 — Financial instruments
On June 22, 2023, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) pursuant to which the Company agreed to issue and sell, in a registered direct offering: (i) an aggregate of 1,330,000 ordinary shares, no par value, and (ii) an aggregate of 1,670,000 Pre-Funded warrants, each representing the right to acquire one ordinary share with exercise price of $0.0001, exercisable at any time until exercised in full and (iii) an aggregate of 3,000,000 Warrants. The Warrants are exercisable immediately upon issuance at an exercise price of $1.50 per Ordinary Share and will expire on the fifth anniversary of the original issuance date. The gross proceeds were approximately $4.5 million before deducting the placement agent fee and related offering expenses. Total issuance expenses in connection with the offering were $455 thousands.
In certain cases, the Warrants and Pre-Funded warrants above may be exercised on a cashless basis. Therefore, the Pre-Funded Warrants accounted for as financial liability and the Warrants are accounted for as derivative instruments and accordingly also classified as a liability. Both liabilities are measured at fair value through profit or loss. In accordance with IFRS 9, the consideration received from the issuance of different financial instruments in a single transaction is attributed initially to financial liabilities that are measured at each period at fair value through profit or loss, and then to financial liabilities that are measured only upon initial recognition at fair value and the remaining amount is recognized as equity component. At the closing, the fair value of the Warrants and Pre-Funded warrants was greater that the gross proceeds received. Therefore, the Company recognized an immediate loss of $1,659 thousand and the entire consideration of $4,500 thousand was allocated to the Warrants and Pre- Funded warrant liability and no consideration has been allocated to equity component. As a result, applicable issuance costs have been recorded as an expense under financing expenses.
The table below presents an analysis of the fair value of the liability in respect to the warrants and prefunded warrants as of June 30, 2023:
Description | Fair value | Level 1 | Level 2 | Level 3 | ||||||||||||
Liability in respect of Pre-Funded Warrants (*) | $ | 2,488 | $ | 2,488 | $ | |||||||||||
Liability in respect of Warrants (**) | $ | 3,495 | $ | 3,495 | $ | |||||||||||
Liability in respect of Warrants (***) | $ | 321 | $ | 321 | $ |
(*) | The fair value of the Pre-Funded Warrant was determined by using the Company’s share price. |
(**) | The fair value of the Warrants was determined by using Black & Sholes method. The following inputs were used to determine the fair value of the Warrant: |
June 30, 2023 |
||||
Financial liabilities: | ||||
Expected volatility (%) | 104.97 | |||
Share price (in $) | 1.49 | |||
Risk-free interest rate (%) | 4.17 | |||
Expected life (years) | 4.98 |
(***) | The fair value of the liability in respect Warrants under level 1 was determined by using the those Warrants price in market. |
NeuroSense Therapeutics Ltd.
Notes to the Condensed Interim Financial Statements as at June 30, 2023
Note 5 — Shareholders’ Equity
Share capital
1. | On April 14, 2023, the Company entered into a sales agreement with Alliance Global Partners, pursuant to which the Company may offer and sell, from time to time, to or through the Alliance Global Partners as agent or principal, ordinary shares an at-the-market offering, having an aggregate offering price of up to $5,744 thousands. On June 22, 2023, the Company filed a prospectus supplement reflecting a reduction in the size of the at-the-market offering to $502 thousands. During the reporting period, the Company sold 3,600 ordinary shares for a gross proceed of $7 thousands through the at-the-market offering. Issuance expenses were equal to the proceeds received. |
2. | On June 23, 2023, one of the Company’s employees exercised 126,000 options into 126,000 ordinary shares for a total consideration of $5 thousands. |
The following table summarizes the movement in share capital:
Ordinary shares |
||||
Six months ended June 30, 2023 |
||||
Issued and paid-in share capital as at January 1 | 11,781,963 | |||
ATM | 3,600 | |||
RSU vesting | 381,479 | |||
Exercise of options to shares | 126,000 | |||
Fund raising | 1,330,000 | |||
Total | 13,623,042 |
NeuroSense Therapeutics Ltd.
Notes to the Condensed Interim Financial Statements as at June 30, 2023
Note 6 — Share Based Payment
On March 20, 2023, the Company’s board of directors, approved the following awards:
● | Grant of 132,040 RSUs to certain officers, in lieu of cash with respect to the 2022 bonus plan grants in the amount of $161 thousand (as described in Note 14(C) to the Company’s 2022 annual financial statement). The RSUs vest quarterly over two years with acceleration condition upon meeting certain milestones. |
● | A bonus for certain employees in the form of 100,000 and 60,000 RSU’s. The RSUs vest on a quarterly basis over one year following the grant and on an annual basis over three years following the grant, respectively. |
● | In addition to the grants in accordance with the 2022 bonus plan mentioned above, additional amount of 137,844 RSUs were granted to one officer. The RSUs vest quarterly over two years with acceleration condition upon meeting certain milestones. |
● | In addition to the grants in accordance with the 2022 bonus plan mentioned above, a grant of additional amount 50,594 RSUs to one officer. The RSUs vest quarterly over two years with acceleration condition upon meeting certain milestones. |
● | In addition to the grants in accordance with the 2022 bonus plan mentioned above, a raise of additional 30% of the annual 2022 bonus will be granted to the Company’s CEO. |
● | The grant of 13,628 Options to a consultant of the Company in in a total fair value of $22,500. The options have an exercise price of $1.82 per share. The options will vest monthly, over 9 months commencing January 1, 2023. The options expire 10 years after their grant date. |
On May 30, 2023, the Company granted 160,000 RSUs to directors of the Company. The RSUs have an exercise price of $1.53 per share. The RSUs shall vest entirely on the first anniversary of the Vesting Commencement Date, provided that no Termination of Employment of the Grantee occurs prior to such anniversary.
The following table lists the inputs used for calculation of fair value of the options granted to consultants as follows:
Six months | ||||
ended | ||||
June 30, | ||||
2023 | ||||
Expected volatility | 100.37%-99.19% | |||
Exercise price | 1.82-2.18 | |||
Share price | 1.49 | |||
Risk-free interest rate | 3.95%-3.94% | |||
Dividend yield | 0 | |||
Expected life (years) | 9.07-9.72 |
NeuroSense Therapeutics Ltd.
Notes to the Condensed Interim Financial Statements as at June 30, 2023
Note 6 — Share Based Payment (Cont.)
The share-based expense recognized in the statements of income were as follows:
Six months | Six months | For the year | ||||||||||
ended | ended | ended | ||||||||||
June 30, | June 30, | December 31, | ||||||||||
2023 | 2022 | 2022 | ||||||||||
Share-based compensation expense – Research and development | 562 | 855 | 1,592 | |||||||||
Share-based compensation expense – General and administrative | 1,222 | 1,953 | 3,513 | |||||||||
1,784 | 2,808 | 5,105 |
Note 7 — Research and development expenses.
Six months | Six months | For the year | ||||||||||
ended | ended | ended | ||||||||||
June 30, | June 30, | December 31, | ||||||||||
2023 | 2022 | 2022 | ||||||||||
Subcontractors and consultants | 2,385 | 1,782 | 3,612 | |||||||||
Share-based compensation | 1,008 | 855 | 1,592 | |||||||||
Salaries and social benefits | 612 | 529 | 1,212 | |||||||||
4,005 | 3,166 | 6,416 |
Note 8 — General and administrative expenses.
Six months | Six months | For the year | ||||||||||
ended | ended | ended | ||||||||||
June 30, | June 30, | December 31, | ||||||||||
2023 | 2022 | 2022 | ||||||||||
Professional services | 529 | 457 | 1,085 | |||||||||
Share-based compensation | 1,271 | 1,953 | 3,513 | |||||||||
Salaries and social benefits | 700 | 406 | 837 | |||||||||
Insurance | 266 | 645 | 1,174 | |||||||||
Traveling abroad | 98 | 56 | 165 | |||||||||
Others | 249 | 171 | 362 | |||||||||
3,113 | 3,688 | 7,136 |
NeuroSense Therapeutics Ltd.
Notes to the Condensed Interim Financial Statements as at June 30, 2023
Note 9 — Financing income (expenses), net
Six months | Six months | For the year | ||||||||||
ended | ended | ended | ||||||||||
June 30, | June 30, | December 31, | ||||||||||
2023 | 2022 | 2022 | ||||||||||
Fair value revaluation of warrants and pre-funded warrants | 73 | 693 | 1,166 | |||||||||
Day 1 loss from issuance of financial instruments | (1,659 | ) | ||||||||||
Bank management fees and commissions | 91 | 23 | 90 | |||||||||
Exchange rate differences | 36 | (50 | ) | (29 | ) | |||||||
Interest on lease liabilities | (6 | ) | (8 | ) | (15 | ) | ||||||
Issuance expenses | (531 | ) | ||||||||||
(1,996 | ) | 658 | 1,212 |
Note 10 — Subsequent events
On August 15, 2023 the Company’s board of directors approved (i) the grant of aggregate amount of 60,000 options to several employees. The options have an exercise price of $0.96 per share and vest quarterly over 3 years starting August 15, 2023, and (ii) the grant of 9,000 options to an employee. The options have an exercise price of $0.96 per share and vest annually over 3 years starting August 15, 2023
11
Exhibit 99.3
OPERATING AND FINANCIAL REVIEW AND PROSPECTS
You should read the following selected financial data and discussion of our operating and financial condition and prospects in conjunction with the financial statements and the notes thereto included elsewhere in this 6-K. Our financial statements are prepared in in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board. Unless otherwise indicated or the context otherwise requires, all references herein to the terms “NeuroSense,” “NeuroSense Therapeutics,” the “Company,” “we,” “us” and “our” refer to NeuroSense Therapeutics Ltd. The term “NIS” refers to New Israeli Shekels, the lawful currency of the State of Israel, and the terms “dollar” or “$” refer to U.S. dollars, the lawful currency of the United States. Unless derived from our financial statements or otherwise indicated, U.S. dollar translations of NIS amounts presented in this exhibit are translated using the rate of NIS 3.7 to $1.00, based on the representative exchange rate reported by the Bank of Israel on June 30, 2023.
Forward Looking Statements
This exhibit contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Many of the forward-looking statements contained in this exhibit can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and other similar expressions that are predictions of or indicate future events and future trends, although not all forward-looking statements contain these identifying words.
Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to substantial risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to a variety of factors, including, but not limited to, those identified under the section titled “Risk Factors” in our Annual Report on Form 20-F, filed with the SEC on March 22, 2023 (the “20-F”), and our other filings with the SEC from time to time. These risks and uncertainties include factors relating to:
● | the going concern reference in our financial statements and our need for substantial additional financing to achieve our goals; | |
● | our limited operating history and history of incurring significant losses and negative cash flows since our inception, which we anticipate will continue for the foreseeable future; |
● | our dependence on the success of our lead product candidate, PrimeC, including our obtaining of regulatory approval to market PrimeC in the United States; |
● | our limited experience in conducting clinical trials and reliance on clinical research organizations and others to conduct them; |
● | our ability to advance our preclinical product candidates into clinical development and through regulatory approval and commercialization; |
● | the results of our clinical trials, which may fail to adequately demonstrate the safety and efficacy of our product candidates; |
● | our ability to achieve the broad degree of physician adoption and use and market acceptance necessary for commercial success; |
● | our reliance on third parties in marketing, producing or distributing products and research materials for certain raw materials, compounds and components necessary to produce PrimeC for clinical trials and to support commercial scale production of PrimeC, if approved; |
● | our receipt of regulatory clarity and approvals for our therapeutic candidates and the timing of other regulatory filings and approvals; |
● | estimates of our expenses, revenues, capital requirements and our needs for additional financing; |
● | our efforts to obtain, protect or enforce our patents and other intellectual property rights related to our product candidates and technologies; and |
● | the impact of the public health, political and security situation in Israel, the U.S. and other countries in which we may obtain approvals for our products or our business. |
The preceding list is not intended to be an exhaustive list of all of our risks and uncertainties. As a result of these factors, we cannot assure you that the forward-looking statements in this exhibit will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of the 6-K that accompanies this exhibit, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information.
The forward-looking statements and opinions contained in this exhibit are based upon information available to us as of the date of the 6-K that accompanies this exhibit and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. The forward-looking statements contained in this exhibit speak only as of the date of the 6-K that accompanies this exhibit, and unless otherwise required by law, we do not undertake any obligation to update them in light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events.
You should read this exhibit, and the documents that we reference herein, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
Overview
We are a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s disease (AD), and Parkinson’s disease (PD). We believe that these diseases represent some of the most significant unmet medical needs of our time, with limited effective therapeutic options available. The burden of these diseases on both patients and society is substantial. For example, the average annual cost of ALS alone is $180,000 per patient, and its estimated annual burden on the U.S. healthcare system is greater than $1 billion. Due to the complexity of neurodegenerative diseases, our strategy is to utilize a combined therapeutic approach to target multiple disease-related pathways.
Our lead therapeutic candidate, PrimeC, is a novel extended-release oral formulation, fixed-dose combination of two FDA-approved drugs, ciprofloxacin and celecoxib. PrimeC is designed to treat ALS by modulating microRNA, synthesis, iron accumulation and neuroinflammation, all of which are hallmarks of ALS pathologies. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have granted PrimeC orphan drug designation for the treatment of ALS. We believe PrimeC’s multifactorial mechanism of action has the potential to significantly prolong lifespan and improve ALS patients’ quality of life, thereby reducing the burden of this debilitating disease on both patients and healthcare systems.
In addition to PrimeC, we have conducted research and development efforts in Alzheimer’s disease and Parkinson’s disease, with a similar strategy of combined products.
We have incurred operating losses in each year since our inception. We incurred net losses of $9.11 million and $6.2 million for the six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023, we had an accumulated deficit of $29.9 million. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates from formulation development through preclinical development and clinical trials, seek regulatory approval and pursue commercialization of any approved product candidate. In addition, we expect that our expenses will increase substantially in connection with our ongoing activities as we:
● | continue the clinical development of PrimeC; |
● | continue the preclinical development of our other product candidates; |
● | file an NDA seeking regulatory approval for any product candidates; |
● | establish a sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any products for which we obtain manufacturing approval; |
● | maintain, expand and protect our intellectual property portfolio; |
● | add equipment and physical infrastructure to support our research and development; |
● | hire additional clinical development, quality control and manufacturing personnel; |
● | incur additional expenses associated with operating as a U.S. public company, including significant legal, accounting, investor relations and other expenses that we did not incur as a private company; and |
● | add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization. |
Operating Results
Revenue
We have not recognized any revenue to date and we do not expect to generate revenue from the sale of products in the near future.
Operating Expenses
Our current operating expenses consist primarily of research and development as well as general and administrative expenses.
Research and Development Expenses
Research and development expenses consist primarily of:
● | salaries for research and development staff and related expenses, including employee benefits and share-based compensation expenses; |
● | expenses for production of our product candidates by contract manufacturers; |
● | expenses paid to contract research organizations and other third parties in connection with the performance of preclinical studies, clinical trials and related expenses; |
● | expenses incurred under agreements with other third parties, including subcontractors, suppliers and consultants that conduct formulation development, regulatory activities and preclinical studies; |
● | expenses incurred to acquire, develop and manufacture preclinical study and clinical trial materials. |
Expenses on research activities is recognized in profit or loss when incurred. Development expenditures, including patent registration costs, are capitalized only if development costs can be measured reliably, the product or process is technically and commercially feasible, future economic benefits are probable, and we intend to and have sufficient resources to complete development and to use or sell the asset. As of June 30, 2023, no development expenditures have met the recognition criteria and thus we have expensed all of our development expenditures as incurred.
We are currently focused on advancing our product candidates, and our future research and development expenses will depend on their clinical success. Research and development expenses will continue to be significant and will increase over at least the next several years as we continue to develop our product candidates and conduct preclinical studies and clinical trials of our product candidates.
We do not believe that it is possible at this time to accurately project total expenses required for us to reach commercialization of our product candidates. Due to the inherently unpredictable nature of preclinical and clinical development, we are unable to estimate with certainty the costs we will incur and the timelines that will be required in the continued development and approval of our product candidates. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. See “Risk Factors—Risks Related to Our Business and Strategy” in the 20-F. In addition, we cannot forecast which product candidates may be subject to future collaborations, if and when such arrangements will be entered into, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel costs, including share-based compensation, related to directors, executive, finance, and human resource functions, insurance costs, facility costs and external professional service costs, including legal, accounting, marketing and audit services and other consulting fees.
We anticipate that our general and administrative expenses will increase in the future as we increase our administrative headcount and infrastructure to support our continued research and development programs and the potential approval and commercialization of our product candidates. We also anticipate that we will incur increased expenses related to audit, legal, regulatory and tax-related services associated with maintaining compliance with Nasdaq and SEC requirements, director and officer insurance premiums, director compensation, and other costs associated with being a public company.
In addition, if any of our product candidates receives regulatory approval and if we determine to invest in building a commercial infrastructure to support the marketing of our products, we expect to incur greater expenses.
Financing income (Expenses), net
Our net financing expenses (income), net consist primarily of fair value revaluation of warrants and prefunded warrants, issuance costs, interest income on deposits, interest expenses on lease liability and differences in the exchange rate between NIS and the U.S. Dollar.
Income Taxes
We have yet to generate taxable income in Israel, as we have historically incurred operating losses resulting in carry forward tax losses totaling approximately $13 million as of June 30, 2023. We anticipate that we will continue to generate tax losses for the foreseeable future and that we will be able to carry forward these tax losses indefinitely to future taxable years. Accordingly, we do not expect to pay taxes in Israel until we have taxable income after the full utilization of our carry forward tax losses.
Results of Operations
Our results of operations for the six months ended June 30, 2023 and 2022 were as follows:
For the Six Months Ended June 30, |
||||||||
(U.S. dollars in thousands except share and per share data) | 2023 | 2022 | ||||||
Statement of Operations: | ||||||||
Research and Development Expenses | (4,005 | ) | (3,166 | ) | ||||
General and Administrative Expenses | (3,113 | ) | (3,688 | ) | ||||
Operating Loss | (7,118 | ) | (6,854 | ) | ||||
Financing Expenses | (2,196 | ) | (58 | ) | ||||
Financing Income | 200 | 716 | ||||||
Net Loss and Comprehensive Loss | (9,114 | ) | (6,196 | ) | ||||
Basic and Diluted Net Loss per Share | (0.77 | ) | (0.55 | ) | ||||
Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 13,623,042 | 11,294,701 |
Research and Development Expenses
The following table describes the breakdown of our research and development expenses for the indicated periods:
For the Six Months Ended June 30, |
||||||||
(U.S. dollars in thousands except share and per share data) | 2023 | 2022 | ||||||
Subcontractors and consultants | $ | 2,385 | 1,782 | |||||
Share-based compensation | 1,008 | 855 | ||||||
Salaries and social benefits | 612 | 529 | ||||||
Others | - | - | ||||||
Total research and development expenses | $ | 4,005 | 3,166 |
Our research and development expenses for the six months ended June 30, 2023 and 2022 were $4,005 thousand and $3,166 thousand, respectively. The increase of $839 thousand, or 27%, was mainly attributed to subcontractors and consultants with respect to our phase 2b clinical study that started in May 2022.
General and Administrative Expenses
The following table describes the breakdown of our general and administrative expenses for the indicated periods:
For the Six Months Ended June 30, |
||||||||
2023 | 2022 | |||||||
U.S. dollars in thousands | ||||||||
Professional services | $ | 529 | 457 | |||||
Share-based compensation | 1,271 | 1,953 | ||||||
Salaries and social benefits | 700 | 406 | ||||||
Insurance | 266 | 645 | ||||||
Traveling abroad | 98 | 56 | ||||||
Others | 249 | 171 | ||||||
$ | 3,113 | 3,688 |
Our general and administrative expenses for the six months ended June 30, 2023 and 2022 were $3,113 thousand and $3,688 thousand, respectively. The decrease of $575 thousand, or 15.6%, was mainly attributed to lower share-based compensation and insurance expenses.
Financing Expenses
Our financing expenses for the six months ended June 30, 2023 and 2022, were $2,196 thousand and $58 thousand, respectively. The increase of $2,138 thousand, or 3,686%, was mainly attributed to liability in respect of warrants and prefunded warrants.
Financing Income
Our financing income for the six months ended June 30, 2023 and 2022 was $200 thousand and $716 thousand, respectively. The decrease of $516 thousand, or 72%, was mainly attributed to change in rate differentials and warrants.
Liquidity and Capital Resources
Overview
Since our inception, we have incurred losses and negative cash flows from our operations. For the six months ended June 30, 2023, we incurred a net loss of $9.1 million while net cash of $4.1 million was used in our operating activities. As of June 30, 2023, we had working capital of $4.56 million, and an accumulated deficit of $29.9 million. As of June 30, 2023, our cash totaled approximately $7.1 million. Our financial statements have been prepared on a going concern basis under which an entity is considered to be able to realize its assets and satisfy its liabilities in the ordinary course of business, and our financial status creates a doubt whether we will continue as a going concern. Our future operations are dependent upon the identification and successful completion of equity or debt financing and the achievement of profitable operations at an indeterminate time in the future. There can be no assurances that we will be successful in completing an equity or debt financing or in achieving or maintaining profitability. The financial statements do not give effect to any adjustments relating to the carrying values and classification of assets and liabilities that would be necessary should we be unable to continue as a going concern.
Through June 30, 2023, we have financed our operations primarily through our initial public offering, private placements, crowd funding and a registered direct offering of equity securities. In May, June and July of 2021, we received $0.80 million from SAFE agreements; in September 2021, we received an additional $1.23 million from previous investors as a result of their exercise of outstanding warrants; in December 2021, we received gross proceeds of approximately $12.0 million from our initial public offering; during 2022, we received approximately $3.87 million as a result of exercise of outstanding warrants; and in June 2023 we received additional gross proceeds of approximately $4.5 million before deducting placement agent fee and related offering expenses million from a registered direct offering.
Cash flows
The following table summarizes our statement of cash flows for the six months ended June 30, 2023 and 2022:
For the Six Months
Ended June 30, |
||||||||
(U.S. dollars in thousands except share and per share data) | 2023 | 2022 | ||||||
Net cash used in operating activities and exchange rates | $ | (4,077 | ) | (4,372 | ) | |||
Net cash used in investing activities | 3,520 | (6,049 | ) | |||||
Net cash provided by financing activities | 4,103 | 3,707 | ||||||
(Decrease) increase in cash and cash equivalents | $ | 3,546 | (6,714 | ) |
Net cash used in operating activities
Net cash used in operating activities (including $1 thousand from the effect of exchange rate changes on cash and cash equivalents) was $4,077 thousand and $4,372 thousand for the six months ended June 30, 2023 and 2022, respectively. The decrease of $295 thousand was mainly attributed to a decrease in operational expenditures during the period.
Net cash used in investing activities
Net cash used in investing activities was $3,520 thousand and $(6,049( thousand for the six months ended June 30, 2023 and 2022, respectively. The increase of $9,569 thousand was mainly attributed to the Change in short term deposit.
Net cash provided by financing activities
Net cash provided by financing activities was $4,103 thousand and $3,707 thousand for the six months ended June 30, 2023 and 2022, respectively. The increase of $396 thousand was mainly attributed to increase in Issuance of shares, warrants and prefunded warrants, net which was partially offset by decrease in Exercise of warrants and options.
Funding Requirements
Since our inception, almost all of our resources have been dedicated to the preclinical and clinical development of our lead product candidate, PrimeC. As of June 30, 2023, we had cash of $7.1 million. We believe that our existing cash as of June 30, 2023 will be sufficient to fund our operations into the second quarter of 2024.
Our present and future funding requirements will depend on many factors, including, among other things:
● | the progress, timing and completion of clinical trials for PrimeC; |
● | preclinical studies and clinical trials for our other product candidates; |
● | the costs related to obtaining regulatory approval for PrimeC and any of our other product candidates, and any delays we may encounter as a result of regulatory requirements or adverse clinical trial results with respect to any of these product candidates; |
● | selling, marketing and patent-related activities undertaken in connection with the commercialization of PrimeC and any of our other product candidates, and costs involved in the development of an effective sales and marketing organization; |
● | the costs involved in filing and prosecuting patent applications and obtaining, maintaining and enforcing patents or defending against claims or infringements raised by third parties, and license royalties or other amounts we may be required to pay to obtain rights to third party intellectual property rights; |
● | potential new product candidates we identify and attempt to develop; and |
● | revenues we may derive either directly or in the form of royalty payments from future sales of PrimeC and any other product candidates. |
For more information as to the risks associated with our future funding needs, see “Risk Factors — We will require substantial additional financing to achieve our goals, and a failure to obtain this capital when needed and on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, commercialization efforts or other operations” in the 20-F.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.
Research and Development, Patents and Licenses, Etc.
For a description of our research and development programs and the amounts that we have incurred pursuant to those programs, please see above, “Operating and Financial Review and Prospects — Operating Results — Research and Development Expenses.”
Trend Information.
Other than as disclosed elsewhere in this exhibit and the accompanying 6-K, we are not aware of any trends, uncertainties, demands, commitments or events for the period from January 1, 2023 to June 30, 2023 that are reasonably likely to have a material adverse effect on our revenue, income, profitability, liquidity or capital resources, or that caused that disclosed financial information to be not necessarily indicative of future operating results or financial condition.