NeuroSense Therapeutics Ltd 6-K/A, filed Jan 19, 2023
NeuroSense Therapeutics Ltd. (NRSN)
About this 6-K/A
NeuroSense Therapeutics Ltd filed this 6-K/A on January 19, 2023.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16
Under the Securities Exchange Act of 1934
For the Month of January 2023
Commission
File Number:
(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 ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
This Form 6-K/A amends the Form 6-K submitted to the Securities and Exchange Commission by NeuroSense Therapeutics Ltd. (the “Company”) on August 31, 2022 (the “Original 6-K”), which inadvertently did not include the Company’s financial results for the second quarter ended June 30, 2022 in XBRL format.
Attached hereto and incorporated by reference herein are Exhibits 99.1, 99.2 and 99.3 that were included in the Original 6-K as well as the Company’s financial results for the second quarter ended June 30, 2022 in XBRL format.
This Report on Form 6-K/A (including, in Exhibit 99.1, only the text under the headings “Financial Summary” and “Forward-Looking Statements”, 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Form F-1 (File No. 333-260338), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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
| Exhibit No. | Description | |
| 99.1 | Press Release, dated August 31, 2022 | |
| 99.2 | Condensed Interim Unaudited Financial Statements as of June 30, 2022 | |
| 99.3 | Operating and Financial Review and Prospects as of June 30, 2022 | |
| 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). |
1
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: January 19, 2023 | By: | /s/ Alon Ben-Noon |
| Alon Ben-Noon | ||
| Chief Executive Officer | ||
2
Exhibit 99.1
NeuroSense Announces Second Quarter 2022 Financial Results and Provides Business Update
CAMBRIDGE, Mass., August 31, 2022 -- 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, 2022 and provided a business update.
“Throughout this quarter NeuroSense achieved multiple milestones, including the initiation of our Phase IIb ALS study. As an integral part of our clinical program, NeuroSense is pioneering the identification and use of novel biomarkers in neurodegenerative diseases. Results observed from the biomarker studies are promising, especially in that they support our clinical strategy. These findings, along with the data we collect from our Phase IIb study, could inform the optimization of a pivotal Phase III study of PrimeC in ALS,” stated NeuroSense’s CEO, Alon Ben-Noon. “With over $10 million in cash and equivalents on our balance sheet at the end of Q2, we are well positioned to complete our Phase IIb study and report topline results in Q2 2023.”
Business Update
| ● | Commenced ALS Phase IIb PARADIGM Clinical Trial with PrimeC |
In Q2 2022, NeuroSense commenced its double-blind, placebo-controlled, multi-center Phase IIb 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 amyotrophic lateral sclerosis (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 IIb trial may enable patient stratification and increase the likelihood of success in a pivotal trial.
| ● | PrimeC and CogniC observed to Target ALS and Alzheimer’s Disease in Successfully Completed Biomarker Studies |
During Q2 2022, the 3rd stage of the Company’s ALS biomarker study was completed. The study revealed that levels of disease-related biomarkers remained unchanged in people living with ALS who were treated with standard of care, in contrast to the statistically significant decline observed in these biomarkers in patients treated with PrimeC in NeuroSense’s Phase IIa study.
Furthermore, a new study on Alzheimer’s disease (AD) biomarkers was also completed. The study identified several biomarkers associated with AD, which the Company believes indicate NeuroSense’s combination drug CogniC, for the treatment of AD, may be effective in targeting the pathways involved in the disease.
| ● | Completed Single and Multi-Dose PK Studies of PrimeC for ALS and GLP Toxicology Study |
In April 2022, NeuroSense initiated a pharmacokinetic (PK) study (NCT05232461) of PrimeC. The PK open-label, randomized, single-dose, three-treatment, three-period crossover study evaluated the effect of food on the bioavailability of PrimeC as compared to the bioavailability of co-administered ciprofloxacin tablets and celecoxib capsules in adult subjects in the U.S. under an FDA cleared IND protocol. Based on preliminary results, the PK profile of PrimeC supports the formulation’s extended-release properties as the active components are released simultaneously.
In August 2022, NeuroSense completed enrollment and dosing of all subjects in a multi-dose PK study (NCT05436678), with results expected in September 2022.
In addition, NeuroSense reported the successful completion of the “in-life” phase of its 90-day GLP Toxicology study. In this study, the components of PrimeC, celecoxib and ciprofloxacin, were administered to rodents at doses 4x the maximal clinical dose. All animals appeared normal, with no significant findings observed. The Company intends to present the data from this study to the FDA as part of PrimeC’s drug development plan.
| ● | Expanded IP Portfolio |
The Canadian Intellectual Property Office granted NeuroSense a key patent titled “Compositions comprising an anti-inflammatory drug and DICER activator for treatment of neuronal diseases” for its lead drug candidate PrimeC. This patent has already been issued to the Company in the U.S. and Australia.
| ● | Key Industry Collaborations and Conferences |
During Q2 2022, NeuroSense strengthened existing connections and explored new scientific collaborations through ALS conferences. NeuroSense’s Chief Medical Officer, Dr. Ferenc Tracik, MD, presented at the ALS Drug Development Summit in Boston, “From Monotherapy to Combination Therapy: Considering a Paradigm Shift to Target Complexity of ALS.” The Company also participated in Maxim Group’s panel discussion on Innovations in ALS: Exploring New Treatments In Development. Following the end of the second quarter, at the World Orphan Drug Congress in Boston, NeuroSense’s Head of Scientific Program, Dr. Shiran Zimri, presented “PrimeC Significantly Alters Key ALS Biomarkers”.
In July, NeuroSense announced a collaboration agreement with NeuraLight Ltd. to advance the science of oculometric digital biomarkers in the detection and monitoring of neurological diseases including ALS through the use of computer vision, artificial intelligence (AI), deep learning algorithms, and machine learning (ML). The NeuroSense-NeuraLight collaboration entails sharing and tracking patient data to advance the identification and use of ALS digital biomarkers.
In addition, NeuroSense joined the EverythingALS Open Innovation Consortium. NeuroSense will support the patient-focused non-profit with ground-breaking patient research in a joint effort to develop treatments. This collaboration will provide insight into patients’ needs and allow the company to better serve the ALS community. NeuroSense’s CEO, Alon Ben-Noon presented at EverythingALS’s Expert Talk Series on August 3, 2022.
Financial Summary
Six Months Ended June 30, 2022
| ● | Research and development expenses for the six months ended June 30, 2022 increased to $3.17 million (of which $2.31 million was in cash) compared to $2.52 million for the six months ended June 30, 2021. This increase was primarily attributable to an increase in expenses to subcontractors and consultants as a result of the commencement of a Phase IIb ALS clinical study in Q2 2022 which were offset by a decrease in share-based compensation expenses. NeuroSense expects research and development expenses will remain steady through 2022, as a result of the clinical study. |
| ● | General and administrative expenses for the six months ended June 30, 2022 increased to $3.69 million (of which $1.74 million in cash) compared to $0.55 million for the six months ended June 30, 2021. This increase was primarily attributable to an increase in salaries and professional services, directors and officers insurance expenses, and share-based compensation related to the costs of being a public company. NeuroSense expects that general and administrative expenses will remain at the same level through 2022. |
| ● | Operating expenses for the six months ended June 30, 2022 were $6.85 million (of which $4.05 million in cash) compared to $3.06 million for the six months ended June 30, 2021 due to the reasons described above. |
2
As of June 30, 2022, NeuroSense had cash and short-term deposits of $10.37 million.
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, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | 4,349 | 11,063 | ||||||
| Short term deposits (*) | 6,025 | - | ||||||
| Other receivables | 707 | 310 | ||||||
| Restricted deposits | 23 | 39 | ||||||
| Total current assets | 11,104 | 11,412 | ||||||
| Non-current assets: | ||||||||
| Right of use assets | 268 | - | ||||||
| Non-current restricted deposit | 35 | - | ||||||
| Property, plant and equipment, net | 46 | 19 | ||||||
| Total non-current assets | 349 | 19 | ||||||
| Total assets | 11,453 | 11,431 | ||||||
| Liabilities and Equity | ||||||||
| Current liabilities: | ||||||||
| Trade payables | 120 | 39 | ||||||
| Other payables | 616 | 558 | ||||||
| Total current liabilities | 736 | 597 | ||||||
| Non Current liabilities: | ||||||||
| Long term lease liability | 190 | - | ||||||
| Liability in respect of warrants | 691 | 1,828 | ||||||
| 881 | 1,828 | |||||||
| Total liabilities | 1,617 | 2,425 | ||||||
| Shareholders’ equity: | ||||||||
| Ordinary shares | - | - | ||||||
| Share premium and capital reserve | 24,478 | 17,452 | ||||||
| Accumulated deficit | (14,642 | ) | (8,446 | ) | ||||
| Total Shareholders’ equity | 9,836 | 9,006 | ||||||
| Total liabilities and shareholders’ equity | 11,453 | 11,431 | ||||||
| (*) | Short term bank deposits for periods of 5-12 months with annual interest rate of 0.91%-2.3%. |
3
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 | 2022 | 2021 | 2021 | |||||||||||||||
| Research and development expenses | 7 | (3,166 | ) | (2,517 | ) | (3,082 | ) | |||||||||||
| General and administrative expenses | 8 | (3,688 | ) | (545 | ) | (2,505 | ) | |||||||||||
| Operating loss | (6,854 | ) | (3,062 | ) | (5,587 | ) | ||||||||||||
| Financing income | 716 | 11 | 2,732 | |||||||||||||||
| Financing expenses | (58 | ) | (1 | ) | (1,186 | ) | ||||||||||||
| Financing income, net | 658 | 10 | 1,546 | |||||||||||||||
| Net loss and comprehensive loss | (6,196 | ) | (3,052 | ) | (4,041 | ) | ||||||||||||
| Basic and diluted net loss per share | (0.55 | ) | (1.62 | ) | (0.65 | ) | ||||||||||||
Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 11,294,701 | 1,887,196 | 6,243,411 | |||||||||||||||
4
Condensed Interim Unaudited Statements of Changes in Equity
U.S. dollars in thousands
| Ordinary | Share Premium And Capital |
Accumulated |
Total | |||||||||||||
| Shares | Reserve | deficit | Equity | |||||||||||||
| Six months ended June 30, 2022: | ||||||||||||||||
| Balance as of 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 of June 30, 2022 | - | 24,478 | (14,642 | ) | 9,836 | |||||||||||
| Six months ended June 30, 2021: | ||||||||||||||||
| Balance as of January 1, 2021 | - | 5,064 | (4,405 | ) | 659 | |||||||||||
| Share-based compensation | - | 2,630 | - | 2,630 | ||||||||||||
| Net loss and comprehensive loss | - | - | (3,052 | ) | (3,052 | ) | ||||||||||
| Issuance of SAFE instruments | - | 700 | - | 700 | ||||||||||||
| Balance as of June 30, 2021 | - | 8,394 | (7,457 | ) | 937 | |||||||||||
| For the year ended December 31, 2021: | ||||||||||||||||
| Balance as of January 1, 2021 | - | 5,064 | (4,405 | ) | 659 | |||||||||||
| Issuance of SAFE instruments | - | 800 | - | 800 | ||||||||||||
| Exercise of warrants and options | - | 1,311 | - | 1,311 | ||||||||||||
| Share-based compensation | - | 4,716 | - | 4,716 | ||||||||||||
| Issuance of ordinary shares, net upon IPO | - | 5,561 | - | 5,561 | ||||||||||||
| Net loss and comprehensive loss | - | - | (4,041 | ) | (4,041 | ) | ||||||||||
| Balance as of December 31, 2021 | - | 17,452 | (8,446 | ) | 9,006 | |||||||||||
5
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 company’s PrimeC and CogniC development programs; 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; and the development and commercial potential of any product candidates of the company. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. 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.
For further information: Email: info@neurosense-tx.com, Tel: +972 (0)9 799 6183
6
Exhibit 99.2
NEUROSENSE THERAPEUTICS LTD.
CONDENSED FINANCIAL STATEMENTS
AS OF JUNE 30, 2022
UNAUDITED
INDEX
NeuroSense Therapeutics Ltd.
Condensed Interim Unaudited Statements of Financial Position
U.S. dollars in thousands
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | ||||||||
| Short term deposits (*) | ||||||||
| Other receivables | ||||||||
| Restricted deposits | ||||||||
| Total current assets | ||||||||
| Non-current assets: | ||||||||
| Right of use assets | - | |||||||
| Non-current restricted deposit | - | |||||||
| Property, plant and equipment, net | ||||||||
| Total non-current assets | ||||||||
| Total assets | ||||||||
| Liabilities and Equity | ||||||||
| Current liabilities: | ||||||||
| Trade payables | ||||||||
| Other payables | ||||||||
| Total current liabilities | ||||||||
| Non Current liabilities: | ||||||||
| Long term lease liability | - | |||||||
| Liability in respect of warrants | ||||||||
| Total liabilities | ||||||||
| Shareholders’ equity: | ||||||||
| Ordinary shares | - | |||||||
| Share premium and capital reserve | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total Shareholders’ equity | ||||||||
| Total liabilities and shareholders’ equity | ||||||||
(*)
Date of approval of the interim financial statements: August 30, 2022
| Alon Ben-Noon | Or Eisenberg | |||
| Chief Executive Officer | Chief Financial Officer | |||
The accompanying notes are an integral part of the condensed interim financial statements.
2
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 | 2022 | 2021 | 2021 | |||||||||||||
| Research and development expenses | 7 | ( | ) | ( | ) | ( | ) | |||||||||
| General and administrative expenses | 8 | ( | ) | ( | ) | ( | ) | |||||||||
| Operating loss | ( | ) | ( | ) | ( | ) | ||||||||||
| Financing income | ||||||||||||||||
| Financing expenses | ( | ) | ( | ) | ( | ) | ||||||||||
| Financing income, net | ||||||||||||||||
| Net loss and comprehensive loss | ( | ) | ( | ) | ( | ) | ||||||||||
| ( | ) | ( | ) | ( | ) | |||||||||||
The accompanying notes are an integral part of the condensed interim financial statements.
3
NeuroSense Therapeutics Ltd.
Condensed Interim Unaudited Statements of Changes in Equity
U.S. dollars in thousands
| Ordinary | Share Premium And Capital |
Accumulated |
Total | |||||||||||||
| Shares | Reserve | deficit | Equity | |||||||||||||
| Six months ended June 30, 2022: | ||||||||||||||||
| Balance as of January 1, 2022 | ( | ) | ||||||||||||||
| Share-based compensation | - | |||||||||||||||
| Net loss and comprehensive loss | - | ( | ) | ( | ) | |||||||||||
| Cancelation of options | - | ( | ) | - | ( | ) | ||||||||||
| Exercise of warrants | - | - | ||||||||||||||
| Balance as of June 30, 2022 | ( | ) | ||||||||||||||
| Six months ended June 30, 2021: | ||||||||||||||||
| Balance as of January 1, 2021 | ( | ) | ||||||||||||||
| Share-based compensation | - | |||||||||||||||
| Net loss and comprehensive loss | - | ( | ) | ( | ) | |||||||||||
| Issuance of SAFE instruments | - | - | ||||||||||||||
| Balance as of June 30, 2021 | ( | ) | ||||||||||||||
| For the year ended December 31, 2021: | ||||||||||||||||
| Balance as of January 1, 2021 | ( | ) | ||||||||||||||
| Issuance of SAFE instruments | - | |||||||||||||||
| Exercise of warrants and options | - | |||||||||||||||
| Share-based compensation | - | |||||||||||||||
| Issuance of ordinary shares , net upon IPO | - | |||||||||||||||
| Net loss and comprehensive loss | - | ( | ) | ( | ) | |||||||||||
| Balance as of December 31, 2021 | ( | ) | ||||||||||||||
The accompanying notes are an integral part of the condensed interim financial statements.
4
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, | ||||||||||
| 2022 | 2021 | 2021 | ||||||||||
| Cash flows from operating activities | ||||||||||||
| Net loss for the period | ( | ) | ( | ) | ( | ) | ||||||
| Adjustments: | ||||||||||||
| Depreciation and amortization | ||||||||||||
| Share-based compensation | ||||||||||||
| Revaluation of liability in respect to warrants | ( | ) | ( | ) | ||||||||
| Loss from disposal of property and equipment | ||||||||||||
| Finance expenses | ||||||||||||
| Changes in assets and liabilities: | ||||||||||||
| Decrease (increase) in other receivables | ( | ) | ( | ) | ||||||||
| Increase (decrease) in trade payables | ( | ) | ( | ) | ||||||||
| Increase (decrease) in other payables | ||||||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ( | ) | ||||||
| Cash flows from investing activities | ||||||||||||
| Investment in short term deposit, net | ( | ) | ||||||||||
| Investment in restricted deposit | ( | ) | ||||||||||
| Purchase of property, plant and equipment | ( | ) | ( | ) | ( | ) | ||||||
| Net cash used in investing activities | ( | ) | ( | ) | ( | ) | ||||||
| Cash flows from financing activities | ||||||||||||
| Proceeds from issuance of SAFE instruments | ||||||||||||
| Share based payment acquired | ( | ) | ||||||||||
| Exercise of warrants and options | ||||||||||||
| Proceeds from issuance of shares and warrants, net | ||||||||||||
| Repayment of lease liability | ( | ) | ||||||||||
| Net cash provided by financing activities | ||||||||||||
| Effects of exchange rate changes on cash and cash equivalents | ( | ) | ||||||||||
| Net increase (decrease) in cash and cash equivalents | ( | ) | ||||||||||
| Cash at beginning of the period | ||||||||||||
| Cash at end of the period | ||||||||||||
| Non-cash activity | ||||||||||||
| Exercise of warrants | ||||||||||||
| Exercise of options | ||||||||||||
| Recognition of right of use assets | ||||||||||||
| (*) |
The accompanying notes are an integral part of the condensed interim financial statements.
5
NeuroSense Therapeutics Ltd.
Notes to the Condensed Interim Financial Statements as of June 30, 2022
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 and initial public offering. 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. The Company will require additional cash to fund the execution of its mid 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. While management is progressing with its plans to secure external financing, there is no assurance that any such arrangement will be entered into or that financing will be available when needed in order to allow the Company 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 decisions could have a material adverse effect on the Company’s business. Based on its current expected level of operating expenditures, the Company believes that its cash resources as of June 30, 2022 will be sufficient to continue the development of the Company’s product through the end of the third quarter of 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, 2021 (the “annual financial statements”).
These condensed interim financial statements were authorized for issuance by the Company’s Board of Directors on August 30, 2022.
6
NeuroSense Therapeutics Ltd.
Notes to the Condensed Interim Financial Statements as of June 30, 2022
Note 2 – Basis of Preparation (Cont.)
| 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.
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 except the following:
IFRS 16, Leases
During the reporting period, International Financial Reporting Standard 16, Leases (hereinafter: “IFRS 16” or “the standard”) become applicable to the Company’s financial statements.
In accordance with IFRS 16, the Company recognizes a right-of-use asset and a lease liability at the commencement of the lease contract for all the leases in which the Company has a right to control identified assets for a specified period of time, other than exceptions specified in the standard. Accordingly, the Company recognizes depreciation and amortization expenses in respect of a right-of-use asset, tests a right-of-use asset for impairment in accordance with IAS 36 and recognizes financing expenses on a lease liability. Therefore, as from the date of January 1, 2022, lease payments relating to assets leased under an operating lease, which were presented as part of general and administrative expenses in the income statement, are capitalized to assets and written down as depreciation and amortization expenses.
On January 1, 2022, the Company
recognized a liability at the present value of the balance of future lease payments discounted at its incremental borrowing rate at
that date calculated according to the average duration of the remaining lease period as from the date of initial application which
was
Furthermore, as part of the initial application of the standard, the Company has chosen to apply the following expedients:
Applying the practical expedient regarding the recognition and measurement of short-term leases, for both leases that end within 12 months from the date of initial application and leases for a period of up to 12 months from the date of their commencement for all groups of underlying assets to which the right-of-use relates.
7
NeuroSense Therapeutics Ltd.
Notes to the Condensed Interim Financial Statements as of June 30, 2022
Note 3 - Significant Accounting Policies (cont’d)
Presented hereunder are the main changes in accounting policies following the application of IFRS 16 as from January 1, 2022:
Contracts that award the Company control over the use of a leased asset for a period of time in exchange for consideration, are accounted for as leases. Upon initial recognition, the Company recognizes a liability at the present value of the balance of future lease payments, and concurrently recognizes a right-of-use asset at the same amount of the lease liability, adjusted for any prepaid or accrued lease payments, plus initial direct costs incurred in respect of the lease.
Subsequent to initial recognition, the right-of-use asset is accounted for using the cost model, and depreciated over the shorter of the lease term or useful life of the asset, which is 4 years.
The lease term
The lease term is the non-cancellable period of the lease plus periods covered by an extension or termination option if it is reasonably certain that the lessee will or will not exercise the option, respectively.
Variable lease payments
Variable lease payments that depend on an index or a rate are initially measured using the index or rate existing at the commencement of the lease and are included in the measurement of the lease liability. When the cash flows of future lease payments change as the result of a change in an index or a rate, the balance of the liability is adjusted against the right-of-use asset.
Other variable lease payments that are not included in the measurement of the lease liability are recognized in profit or loss in the period in which the event or condition that triggers payment occurs.
Note 4 - Liability in Respect of Warrants
The fair value of the liability in respect to the warrants at June 30, 2022 and December 31, 2021 was determined according to the warrant price at the stock market (fair value measurement at level 1).
The Company’s financial liabilities measured at fair value on a recurring basis, consisted of the following types of instruments as of the following dates:
| June 30, 2022 | ||||||||||||||||
| Description | Fair value | Level 1 | Level 2 | Level 3 | ||||||||||||
| Liability in respect of warrants | $ | $ | $ | $ | ||||||||||||
| December 31, 2021 | ||||||||||||||||
| Description | Fair value | Level 1 | Level 2 | Level 3 | ||||||||||||
| Liability in respect of warrants | $ | $ | $ | $ | ||||||||||||
8
NeuroSense Therapeutics Ltd.
Notes to the Condensed Interim Financial Statements as of June 30, 2022
Note 5 – Lease
In December 2021, the Company entered
into an office space lease agreement, which commenced on January 1, 2022. Monthly rent payments including utilities amount to approximately
Right-of-use-assets
Carrying amounts of right-of-use assets and movement during the period:
| June 30, 2022 | ||||
| Balance as of January 1, 2022 | ||||
| Initial recognition | ||||
| Depreciation on right-of-use-assets | ( | ) | ||
| Balance as of June 30, 2022 | ||||
Lease liability
Maturity analysis of the Company’s lease liabilities
| June 30, 2022 | ||||
| Less than one year | ||||
| One to four years | ||||
| Total | ||||
| Current maturities of lease liability | ( | ) | ||
| Long-term lease liability | ||||
Additional information on leases
The following is a summary of weighted average remaining lease terms and discount rate for Company’s leases:
| June 30, 2022 | ||||
| Lease term (years) | ||||
| Weighted average discount rate | % | |||
The following are the amounts recognized in profit or loss:
| June 30, 2022 | ||||
| Interest expenses on lease liability | ||||
| Amortization of right-of-use-assets | ||||
| Total | ||||
9
NeuroSense Therapeutics Ltd.
Notes to the Condensed Interim Financial Statements as of June 30, 2022
Note 5 – Lease (Cont.)
Presented hereunder are the lease payments the Company paid in respect of these leases in the six months ended June 30, 2022:
| Fixed payments | Total payments | |||||||
| Lease payments | $ | |||||||
Amounts recognized in the statement of cash flows
| Six months ended June 30, 2022 | Six months ended June 30, 2021 | For the year ended December 31, 2021 | ||||||||||
| Cash flows for leases | $ | |||||||||||
Note 6 – Shareholders’ Equity
On January 10 and
January 11, 2022, the Company entered into option settlement agreement (“Agreements”) with certain consultants of the Company.
Pursuant to the Agreements, the Company exchanged
On January 25, 2022 and March 10, 2022,
the Company’s board of directors and shareholders, respectively, approved the compensation of each of the Company’s external directors
and a newly appointed director.
On January 25, 2022, the Company’s
board of directors approved the grant of aggregate amount of
In March 2022, the Company’s board
of directors approved the grant of an aggregate amount of
10
NeuroSense Therapeutics Ltd.
Notes to the Condensed Interim Financial Statements as of June 30, 2022
Note 6 – Shareholders’ Equity (Cont.)
The following table lists the inputs used for calculation of fair value of the options granted to employees and directors during the reporting period, at the date of grant:
| Grant date | |||||
| Expected volatility | |||||
| Exercise price | |||||
| Share price | |||||
| Risk-free interest rate | |||||
| Dividend yield | |||||
| Expected life | |||||
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, | ||||||||||
| 2022 | 2021 | 2021 | ||||||||||
| Share-based compensation expense – Research and development | ||||||||||||
| Share-based compensation expense – General and administrative | ||||||||||||
| Share-based compensation expense – Finance expenses | ||||||||||||
In March 2022, the
Company received an amount of $
Note 7 – Research and development expenses
| Six months | Six months | For the year | ||||||||||
| ended | ended | ended | ||||||||||
| June 30, | June 30, | December 31, | ||||||||||
| 2022 | 2021 | 2021 | ||||||||||
| Subcontractors and consultants | ||||||||||||
| Share-based compensation | ||||||||||||
| Salaries and social benefits | ||||||||||||
| Others | - | |||||||||||
11
NeuroSense Therapeutics Ltd.
Notes to the Condensed Interim Financial Statements as of June 30, 2022
Note 8 – General and administrative expenses
| Six months | Six months | For the year | ||||||||||
| ended | ended | ended | ||||||||||
| June 30, | June 30, | December 31, | ||||||||||
| 2022 | 2021 | 2021 | ||||||||||
| Professional services | ||||||||||||
| Share-based compensation | ||||||||||||
| Salaries and social benefits | ||||||||||||
| Insurance | ||||||||||||
| Traveling abroad | ||||||||||||
| Others | ||||||||||||
Note 9 – Subsequent Events
On August 30, 2022, the Company’s board of directors approved an amendment to the Company’s 2018 Employee Share Option Plan (the “Amendment”). Among other things, the Amendment provides the ability to grant additional equity instruments (as opposed to just options).
On August 30, 2022, the Company’s
board of directors approved the grant of aggregate amount of
12
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 3.5 to $1.00, based on the representative exchange rate reported by the Bank of Israel on June 30, 2022.
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 April 14, 2022 (the “20-F”), and our other filings with the SEC from time to time. These risks and uncertainties include factors relating to:
| ● | 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.
2
Overview
We are a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. We believe that these diseases, which include 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. 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 develop combined therapies targeting multiple pathways associated with these diseases.
Our lead product candidate, PrimeC, is a novel extended-release, or ER, oral formulation of a fixed dose combination of two generic FDA-approved drugs, ciprofloxacin and celecoxib, combined in a specific ratio. Ciprofloxacin was approved to treat or prevent a variety of bacterial infections and celecoxib was approved as a prescription nonsteroidal anti-inflammatory drug used to treat pain.
PrimeC is designed to treat ALS by regulating microRNA, or miRNA, synthesis, influencing iron accumulation and reducing neuroinflammation, all of which are hallmarks of ALS pathologies. The U.S. Food and Drug Administration, or FDA, and the European Medicines Agency, or EMA, have both granted PrimeC an 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 recently initiated 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 $6.20 million and $3.05 million for the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022, we had an accumulated deficit of $14.64 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 a Phase IIb trial and commence a pivotal Phase III trial for PrimeC, in addition to additional clinical studies to support our future regulatory submissions; |
| ● | 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; |
3
| ● | 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
The largest component of our total operating expenses has historically been, and we expect will continue to be, research and development (excluding share based payments). 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, 2022, no development expenditures have met the recognition criteria and thus we have expensed all of our development expenditures as incurred.
4
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, 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 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 $6.20 million as of June 30, 2022. 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.
5
Results of Operations
Our results of operations for the six months ended June 30, 2022 and 2021 were as follows:
| For the Six Months Ended June 30, | ||||||||
| (U.S. dollars in thousands except share and per share data) | 2022 | 2021 | ||||||
| Statement of Operations: | ||||||||
| Research and Development Expenses | (3,166 | ) | (2,517 | ) | ||||
| General and Administrative Expenses | (3,688 | ) | (545 | ) | ||||
| Operating Loss | (6,854 | ) | (3,062 | ) | ||||
| Financing Expenses | (58 | ) | (1 | ) | ||||
| Financing Income | 716 | 11 | ||||||
| Net Loss and Comprehensive Loss | (6,196 | ) | (3,052 | ) | ||||
| Basic and Diluted Net Loss per Share | (0.55 | ) | (1.62 | ) | ||||
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 11,294,701 | 1,887,196 | ||||||
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) | 2022 | 2021 | ||||||
| Subcontractors and consultants | $ | 1,782 | 144 | |||||
| Share-based compensation | 855 | 2,210 | ||||||
| Salaries and social benefits | 529 | 150 | ||||||
| Others | - | 13 | ||||||
| Total research and development expenses | $ | 3,166 | 2,517 | |||||
Our research and development expenses for the six months ended June 30, 2022 and 2021 were $3,166 thousand and $2,517 thousand, respectively. The increase of $649 thousand, or 26%, was mainly attributed to an increase in expenses for subcontractors and consultants as a result of the commencement of a Phase IIb ALS clinical study in 2022, which was offset by a decrease in share-based compensation expenses.
6
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, | ||||||||
| 2022 | 2021 | |||||||
| U.S. dollars in thousands | ||||||||
| Professional services | $ | 457 | 84 | |||||
| Share-based compensation | 1,953 | 420 | ||||||
| Salaries and social benefits | 406 | 21 | ||||||
| Insurance | 645 | 3 | ||||||
| Traveling abroad | 56 | 10 | ||||||
| Others | 171 | 7 | ||||||
| $ | 3,688 | 545 | ||||||
Our general and administrative expenses for the six months ended June 30, 2022 and 2021 were $3,688 thousand and $545 thousand, respectively. The increase of $3,143 thousand, or 576%, was mainly attributed to an increase in salaries and professional services, directors and officers insurance expenses, and share-based compensation, all related to the costs of being a public company.
Financing Expenses
Our financing expenses for the six months ended June 30, 2022 and 2021, were $58 thousand and $1 thousand, respectively. The increase of $57 thousand, or 570%, was mainly attributed to exchange rate expenses.
Financing Income
Our financing income for the six months ended June 30, 2022 and 2021 was $716 thousand and $11 thousand, respectively. The increase of $705 thousand, or 640%, was mainly attributed to a revaluation of the fair value of warrants.
7
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, 2022, we incurred a net loss of $6.19 million while net cash of $4.28 million was used in our operating activities. As of June 30, 2022, we had working capital of $10.37 million, and an accumulated deficit of $14.64 million. As of June 30, 2022, our cash and short term deposits totaled approximately $10.37 million. Based on current expected level of operating expenditures, our cash resources as at June 30, 2022 will be sufficient will be sufficient to continue the development of the Company’s product through the end of the third quarter of 2023. Through June 30, 2022, we have financed our operations primarily through our initial public offering, private placements and crowd funding of equity securities. Total gross invested capital as of June 30, 2022 was $20.3 million, which included ordinary shares, SAFE Agreements, options and warrants to purchase ordinary shares. 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; and in March 2022 we received gross proceeds of approximately $3.8 million from the exercise of warrants.
Cash flows
The following table summarizes our statement of cash flows for the six months ended June 30, 2022 and 2021:
| For the Six Months Ended June 30, | ||||||||
| (U.S. dollars in thousands except share and per share data) | 2022 | 2021 | ||||||
| Net cash used in operating activities and exchange rates | $ | (4,372 | ) | (403 | ) | |||
| Net cash used in investing activities | (6,049 | ) | (2 | ) | ||||
| Net cash provided by financing activities | 3,707 | 700 | ||||||
| (Decrease) increase in cash and cash equivalents | $ | (6,714 | ) | 295 | ||||
Net cash used in operating activities
Net cash used in operating activities (including $86 thousand from the effect of exchange rate changes on cash and cash equivalents) was $4,372 thousand and $403 thousand for the six months ended June 30, 2022 and 2021, respectively. The increase of $3,969 thousand was mainly attributed to an increase in our operating expenses.
Net cash used in investing activities
Net cash used in investing activities was $6,049 thousand and $2 thousand for the six months ended June 30, 2022 and 2021, respectively. The increase of $6,047 thousand was mainly attributed to an increase in investment in short term deposits.
8
Net cash provided by financing activities
Net cash provided by financing activities was $3,707 thousand and $700 thousand for the six months ended June 30, 2022 and 2021, respectively. The increase of $3,007 thousand was mainly attributed to an increase in funds received from the exercise of warrants and options, and was offset by a decrease in proceeds from the issuance of SAFE instruments.
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, 2022, we had cash and short term deposits of $10.37 million. Based on our current expected level of operating expenditures, we believe that our cash resources as of June 30, 2022 will be sufficient to continue our operations through the end of the third quarter of 2023.
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.
9
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, 2022 to June 30, 2022 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.
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.
10