preloader icon

Apex Trader Funding (ATF) - News

NeuroSense Management Provides Corporate Update and First Quarter 2024 Financial Results

Following positive 6-month clinical outcomes from phase 2b (PARADIGM) clinical trial, Company expects additional biomarker and 12-month clinical in the near term  CAMBRIDGE, Mass., June 24, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a company developing novel treatments for severe neurodegenerative diseases, today provides a corporate update following its recently announced analyses from its Phase 2b PARADIGM clinical trial, which demonstrated a statistically significant slowing of disease progression in high-risk ALS patients treated with PrimeC by 43% (p=0.02) as compared to placebo in the pre-specified per protocol (PP) population analysis after six months of treatment.[1]  As previously indicated, the slowing of disease progression demonstrated by PrimeC versus placebo translates to a 5.04-point difference in the ALSFRS-R in favor of PrimeC (Confidence Interval: 0.862, 9.214; n=38). Corporate Highlights for the near term include: 12-month clinical results, including survival, expected in June 2024 FDA meeting anticipated in Q3 2024 Started preparations for Phase 3 clinical trial in the US, including protocol submission expected by year-end 2024 NeuroSense CEO Alon Ben-Noon states, "We are continuing to see additional results coming in from the PARADIGM trial and as they are being analyzed and verified, we intend to share them with shareholders.  We anticipate sharing 12-month survival data, ALSFRS-R –as well as providing some additional biomarker data.  These will include iron, ferritin and transferrin. We are looking forward to presenting target-engagement biomarkers alongside the clinical outcomes. In the meantime, we continue our discussions with several potential partners in order to drive our clinical programs forward efficiently." In addition, the Company hereby provides its Q1 2024 financial results: Research and development expenses for the three months ended March 31, 2024 and 2023 were $1.88 and $1.85 million, respectively. Research and development expenses remained at the same level primarily due to an increase in expenses to subcontractors and consultants as well as salaries and social benefits as a result of the progression of the Phase 2b ALS clinical study, which were fully offset by a decrease in share-based compensation expenses. NeuroSense expects research and development expenses to remain steady through the remainder of 2024 as a result of the open label extension of the Phase 2b ALS clinical study and the ongoing of the Phase 2 AD study. General and administrative expenses for the three months ended March 31, 2024 and 2023 were $1.11 and $1.14 million, respectively. General and administrative expenses remained at the same level primarily due to a decrease in salaries and social benefits, share-based compensation and insurance expenses, which were fully offset by increase in professional services. NeuroSense expects general and administrative expenses to remain steady through the remainder of 2024. Operating expenses for the three months ended March 31, 2024 and 2023 were $3 million due to the reasons described above. As of March 31, 2024, NeuroSense had cash of $0.74 million, which does not include gross proceeds of approximately $4.5 million from a financing that the Company completed in April 2024. As part of the transaction, the Company entered into a securities purchase agreement, pursuant to which the Company issued in a registered direct offering (i) 1,732,000 ordinary shares; (ii)pre-funded warrants to purchase 1,248,000 ordinary shares at an exercise price of $0.0001, exercisable at any time upon their issuance until exercised in full and (iii) warrants to purchase 2,980,000 ordinary shares at an exercise price of $1.50. Following the end of the first quarter of 2024, the Company determined to change its accounting method from IFRS to U.S. GAAP and accordingly has reissued its audited financial statements for all periods covered by its 2023 financial statements under U.S. GAAP. A copy of the reissued financial statements and accompanying financial data has been filed with the Securities and Exchange Commission on Form 6-K. The Company's unaudited consolidated financial results for the three months ended March 31, 2024 are presented in accordance with US GAAP Reporting Standards. A summary of NeuroSense's unaudited consolidated financial results is included in the tables below. Ben-Noon concluded, "We continue to build strong clinical evidence for PrimeC and are looking forward to upcoming announcements. Concurrently, we are working to safeguard our financial future and ability to continue our clinical activities so as to ensure that there is adequate cash on the balance sheet to complete these milestones. We plan to meet with the FDA in Q3 2024 to discuss the clinical path forward towards an NDA submission, which we believe will be a major inflection point for NeuroSense. The coming months hold tremendous potential, and we are optimistic about the outcomes and the future for NeuroSense Therapeutics." [1] High-risk patients, defined by the European Network for the Cure of ALS (ENCALS) Risk Factor as those with a higher risk for rapid disease progression, comprise approximately 50% of the total ALS population.   NeuroSense Therapeutics Ltd. Condensed Interim Balance Sheets U.S. dollars in thousands except share and per share data March 31, December 31, 2024 2023 Unaudited Assets Current assets: Cash and cash equivalent 735 2,640 Other receivables 421 236 Restricted deposit 36 40 Total current assets 1,192 2,916 Non-current assets: Property and equipment, net 88 85 Operating right of use assets 143 162 Restricted deposit 23 22 Total non-current assets 254 269 Total assets 1,446 3,185 Liabilities and Shareholders' Deficit Current liabilities: Trade payables 2,384 1,459 Other payables 2,151 2,000 Total current liabilities 4,535 3,459 Non-Current liabilities: Operating long-term lease liability 55 73 Liability in respect of warrants 3,849 1,412 3,904 1,485 Total liabilities 8,439 4,944