Full Press Release Details
Announces Second Quarter 2023 Financial Results and Provides Business Update
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."
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
Phase 2b Amyotrophic Lateral Sclerosis (ALS) PARADIGM Trial Completed
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
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.
Six Months Ended June 30, 2023
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
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 Premium And 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 |
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
Forward-Looking Statements
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.
For further information: Email: info@neurosense-tx.com, Tel: +972 (0)9