NeuroSense Therapeutics Ltd 6-K, filed May 31, 2022
NeuroSense Therapeutics Ltd. (NRSN)
About this 6-K
NeuroSense Therapeutics Ltd filed this 6-K on May 31, 2022.
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 May 2022
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 ☐
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): ☐
On May 31, 2022, NeuroSense Therapeutics Ltd. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended March 31, 2022 and a business update. A copy of the press release is filed herewith as Exhibit 99.1.
Exhibit Index
| Exhibit No. | Description | |
| 99.1 | Press Release, dated May 31, 2022 |
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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: May 31, 2022 | By: | /s/ Alon Ben-Noon |
| Alon Ben-Noon | ||
| Chief Executive Officer | ||
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Exhibit 99.1
NeuroSense Announces First Quarter 2022 Financial Results and Provides Business Update
CAMBRIDGE, Mass., May 31, 2022 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today reported its financial results for the quarter ended March 31, 2022 and provided a business update.
Business Update
Initiated Biomarker Studies for ALS and Alzheimer's disease
Throughout Q1 2022, NeuroSense has been working vigorously to meet key drug development milestones. As an integral part of its clinical program, NeuroSense is pioneering the identification and use of novel disease related biomarkers in neurodegenerative diseases. During Q1 2022, the 3rd stage of the Company's amyotrophic lateral sclerosis (ALS) biomarker study was initiated in collaboration with Massachusetts General Hospital (MGH) in Boston, and a new study on Alzheimer's disease (AD) biomarkers also commenced. Results from both studies are expected in Q2 2022.
Received FDA Clearance of IND for PrimeC in Treatment of ALS
NeuroSense continues to advance its regulatory strategy via the U.S. Food and Drug Administration (FDA). In Q1 2022, the FDA cleared NeuroSense's Investigational New Drug (IND) application to initiate a pharmacokinetic (PK) study of PrimeC, its lead combination drug candidate developed for the treatment of ALS. In addition, a Fast Track application was submitted to the FDA and not granted at this time. The Company is planning to resubmit the application upon further generation of data. PrimeC was previously granted Orphan Drug Designation by the FDA and EMA.
Commenced Enrollment and Dosing in U.S. PK Study of PrimeC for ALS
In April 2022, NeuroSense enrolled and dosed the first healthy volunteer in its PK study (NCT05232461) of PrimeC. The PK open-label, randomized, single-dose, three-treatment, three-period crossover study is evaluating the effect of food on the bioavailability of PrimeC as compared to the bioavailability of co-administered ciprofloxacin tablets and celecoxib capsules in 12 healthy adult subjects in the U.S. under an FDA cleared IND protocol. Data are expected in Q3 2022. The combined data from both this PK study and the Company's upcoming Phase IIb ALS study will assist in designing a pivotal Phase III trial of PrimeC for the treatment of ALS in alignment with FDA requirements.
On Track to Initiate Phase IIb PrimeC Study for ALS
In Q2 2022, NeuroSense expects to commence its double blind, placebo controlled, multicenter Phase IIb clinical trial using a unique upgraded formulation of PrimeC which maximizes 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 statistically significant biomarker data from the upcoming Phase IIb trial may enable patient stratification and increased likelihood of success in a pivotal trial.
Patents Granted for PrimeC in Australia and Canada
NeuroSense continues to bolster its intellectual property estate, with patents granted for PrimeC, during Q1 2022 in Australia and Canada. The same patent, titled "Compositions comprising an anti-inflammatory drug and DICER activator for treatment of neuronal diseases" was previously granted in the U.S.
Collaborations & Strategic Partnerships
In expanding its business development objectives, NeuroSense is discussing potential partnerships with pharmaceutical companies devoted to rare and central nervous system diseases. NeuroSense is currently establishing new scientific collaborations, as well as strengthening existing connections.
"The upcoming initiation of our Phase IIb ALS study is a major milestone for NeuroSense. We move forward in a strong financial position, poised to execute our clinical development plans for the benefit of patients and shareholders. With our current cash position, we expect to complete preclinical studies for Alzheimer's and Parkinson's diseases and, most importantly complete our ALS Phase IIb study, leading to a potential inflection point in value for our Company," stated NeuroSense's CEO, Alon Ben-Noon.
Financial Summary
As of March 31, 2022, NeuroSense had cash and short-term deposits in a total amount of $13.74 million, compared to $11.06 million as of December 31, 2021. The increase was due to proceeds received from the exercise of warrants in the amount of $3.87 million, partly offset by ongoing expenses.
Research and development expenses for the three months ended March 31, 2022 were $1.29 million, a decrease of $0.73 million, or 36.14%, compared to $2.02 million for the three months ended March 31, 2021. The decrease is primarily due to the reduction in share-based compensation expenses, offset by an increase in expenses to subcontractors and consultants as a result of preparations to commence a Phase IIb ALS clinical study in Q2 2022. NeuroSense expects research and development expenses will continue to increase through 2022 and beyond.
General and administrative expenses for the three months ended March 31, 2022 were $1.97 million an increase of $1.88 million, or 2,089%, compared to $0.09 million for the three months ended March 31, 2021. This increase is primarily due to the increase in salaries and professional services, director's and officer's 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.
Financing expenses for the three months ended March 31, 2022 were $23,000 an increase of $10,000, or 77%, compared to $13,000 for the three months ended March 31, 2021. The increase was mainly due to higher exchange rate expenses.
Financing income for the three months ended March 31, 2022 was $0.57 million an increase of $0.57 million, compared to $0 for the three months ended March 31, 2021. The increase in financing income was mainly due to the devaluation of the Company's liability with respect to warrants which were issued at the end of 2021 as part of NeuroSense's initial public offering.
Net loss for the three months ended March 31, 2022 was $2.71 million an increase of $0.59 million, compared with a net loss of $2.12 million for the three months ended March 31, 2021. The increase was primarily due to an increase in general and administrative expenses, partly offset by a decrease in research and development expenses and an increase in financing income.
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A summary of Company's unaudited financial results is included in the tables below.
| Condensed Interim Unaudited Statements of Financial Position | ||||||||
| U.S. dollars in thousands | ||||||||
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | 8,735 | 11,063 | ||||||
| Short term deposits | 5,004 | - | ||||||
| Other receivables | 225 | 310 | ||||||
| Restricted deposits | 64 | 39 | ||||||
| Total current assets | 14,028 | 11,412 | ||||||
| Non-current assets: | ||||||||
| Right of use assets | 287 | - | ||||||
| Property, plant and equipment, net | 42 | 19 | ||||||
| Total non-current assets | 329 | 19 | ||||||
| Total assets | 14,357 | 11,431 | ||||||
| Liabilities and Equity Current liabilities: | ||||||||
| Trade payables | 180 | 39 | ||||||
| Other payables | 1,048 | 558 | ||||||
| Total current liabilities | 1,228 | 597 | ||||||
| Non-current liabilities: | ||||||||
| Long term lease liability | 207 | - | ||||||
| Liability in respect of warrants | 816 | 1,828 | ||||||
| 1,023 | 1,828 | |||||||
| Total liabilities | 2,251 | 2,425 | ||||||
| Shareholders' equity: | ||||||||
| Ordinary shares | - | - | ||||||
| Share premium and capital reserve | 23,267 | 17,452 | ||||||
| Accumulated deficit | (11,161 | ) | (8,446 | ) | ||||
| Total Shareholders' equity | 12,106 | 9,006 | ||||||
| Total liabilities and shareholders' equity | 14,357 | 11,431 | ||||||
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| Condensed Interim Unaudited Statements of Income and Comprehensive Loss | ||||||||||||||||
| U.S. dollars in thousands except share and per share data | ||||||||||||||||
| Three months ended | Three months ended | For the year ended | ||||||||||||||
| March 31, | March 31, | December 31, | ||||||||||||||
| Note | 2022 | 2021 | 2021 | |||||||||||||
| Research and development expenses | 5 | (1,296 | ) | (2,019 | ) | (3,082 | ) | |||||||||
| General and administrative expenses | 6 | (1,968 | ) | (92 | ) | (2,505 | ) | |||||||||
| Operating loss | (3,264 | ) | (2,111 | ) | (5,587 | ) | ||||||||||
| Financing expenses | (23 | ) | (13 | ) | (1,186 | ) | ||||||||||
| Financing income | 572 | - | 2,732 | |||||||||||||
| Financing income (expenses), net | 549 | (13 | ) | 1,546 | ||||||||||||
| Net loss and comprehensive loss | (2,715 | ) | (2,124 | ) | (4,041 | ) | ||||||||||
| Basic and diluted net loss per share | (0.24 | ) | (0.38 | ) | (0.65 | ) | ||||||||||
Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 10,994,264 | 5,582,922 | 6,243,411 | |||||||||||||
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| Condensed Interim Unaudited Statements of Changes in Equity | ||||||||||||||||
| U.S. dollars in thousands | ||||||||||||||||
Ordinary Shares | Share Premium And Capital Reserve | Accumulated deficit | Total Equity | |||||||||||||
| Three months ended March 31, 2022: | ||||||||||||||||
| Balance as of January 1, 2022 | - | 17,452 | (8,446 | ) | 9,006 | |||||||||||
| Share-based compensation | - | 1,597 | - | 1,597 | ||||||||||||
| Net loss and comprehensive loss | - | - | (2,715 | ) | (2,715 | ) | ||||||||||
| Cancelation of options | - | (96 | ) | - | (96 | ) | ||||||||||
| Exercise of warrants | - | 4,314 | - | 4,314 | ||||||||||||
| Balance as of March 31, 2022 | - | 23,267 | (11,161 | ) | 12,106 | |||||||||||
| Three months ended March 31, 2021: | ||||||||||||||||
| Balance as of January 1, 2021 | - | 5,064 | (4,405 | ) | 659 | |||||||||||
| Share-based compensation | - | 1,975 | - | 1,975 | ||||||||||||
| Net loss and comprehensive loss | - | - | (2,124 | ) | (2,124 | ) | ||||||||||
| Issuance of SAFE instrument | - | 100 | - | 100 | ||||||||||||
| Balance as of March 31, 2021 | - | 7,139 | (6,529 | ) | 610 | |||||||||||
| For the year ended December 31, 2021: | ||||||||||||||||
| Balance as of January 1, 2021 | - | 5,064 | (4,405 | ) | 659 | |||||||||||
| Issuance of SAFE instrument | - | 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 | |||||||||||
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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 patent applications; the company's PrimeC development program; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the timing of current and future clinical trials; 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
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