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NeuroSense Announces Second Quarter 2022 Financial Results and Provides Business Update

Key Takeaway: NeuroSense Therapeutics Ltd. has announced its financial results for the second quarter of 2022, highlighting advancements in its Phase IIb clinical trial for ALS. The company has successfully completed a significant milestone with the initiation of ALS biomarker studies, which yielded promising results. Despite facing substantial net losses, NeuroSense's cash position remains robust at over $10 million. Additionally, strategic collaborations are underway to enhance ALS monitoring using advanced technologies.

Market Sentiment Analysis

POSITIVE FACTORS

  • NeuroSense is progressing well in its Phase IIb ALS study, initiating multiple milestones.
  • The financial position is strong with over $10 million in cash and equivalents.
  • Promising biomarkers results may enhance clinical strategy and patient outcomes.
  • Collaboration with NeuraLight is expected to advance ALS detection and monitoring.

CONCERNS & RISKS

  • The company reported a significant net loss of approximately $6.2 million for H1 2022.
  • Cash reserves decreased since the previous quarter ended in December 2021, raising concerns over future funding.

Full Press Release Details

NeuroSense Announces Second Quarter 2022 Financial
Results and Provides Business Update
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
"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."
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.
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.
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
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.
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".
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.
Six Months Ended June
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.
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
Interim Unaudited Statements of Income and Comprehensive Loss
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
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
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.
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

Frequently Asked Questions

What recent milestone did NeuroSense achieve in ALS research?

NeuroSense initiated its Phase IIb ALS study during Q2 2022.

How much cash did NeuroSense have by the end of Q2 2022?

NeuroSense reported over $10 million in cash and equivalents.

What is PrimeC used for in NeuroSense's clinical trials?

PrimeC is being tested for its efficacy in treating amyotrophic lateral sclerosis (ALS).

What key patent did NeuroSense receive in Canada?

NeuroSense received a patent for PrimeC for treating neuronal diseases.

What study did NeuroSense complete related to Alzheimer's disease?

NeuroSense completed a study identifying biomarkers associated with Alzheimer's disease.

Last updated: Jan 19, 2023