NeuroSense Therapeutics Ltd 6-K, filed Mar 15, 2022
NeuroSense Therapeutics Ltd. (NRSN)
About this 6-K
NeuroSense Therapeutics Ltd filed this 6-K on March 15, 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 March 2022
Commission File Number: 001-41084
NeuroSense Therapeutics Ltd.
(Translation of registrant’s name into English)
11 HaMenofim Street, Building B
Herzliya 562 Israel
+972-9-9531142
(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): ☐
Special Meeting of Shareholders
On March 10, 2022, NeuroSense Therapeutics Ltd. (the “Company”) held a Special Meeting of Shareholders (the “Meeting”). At the Meeting, all proposed resolutions, as further detailed in the Company’s Notice and Proxy Statement furnished on Form 6-K to the Securities and Exchange Commission on January 31, 2022, were approved by shareholders.
The foregoing paragraph of this Form 6-K is hereby incorporated by reference into the Company's Registration Statement on Form S-8 (Registration No. 333-262480).
Company Presentation
The Company has made available a presentation about its business (the “Presentation”), a copy of which is furnished herewith as Exhibit 99.1 to this Report on Form 6-K and is hereby incorporated by reference. The furnishing of the Presentation is not an admission as to the materiality of any information therein. The information contained in the Presentation is summary information that should be considered in the context of the Company’s filings with the SEC and other public announcements the Company may make by press release or otherwise from time to time.
Press Release
On March 15, 2022, the Company issued a press release announcing its participation in the 2022 Virtual Growth Conference, presented by Maxim Group LLC and hosted by M-Vest, on March 28, 2022. A copy of the press release is filed herewith as Exhibit 99.2 .
Exhibit Index
| Exhibit No. | Description | |
| 99.1 | Presentation, dated March 2022 | |
| 99.2 | Press Release, dated March 15, 2022 |
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: March 15, 2022 | By: | /s/ Alon Ben-Noon |
| Alon Ben-Noon | ||
| Chief Executive Officer | ||
2
Exhibit 99.1
1 Corporate Presentation March 2022 Nasdaq: NRSN
Trademarks in this presentation are the property of their respective owners and used for informational and educational purposes only. 2 Disclaimer This presentation and oral statements made regarding the subject of this presentation contain "forward - looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements contained in this presentation other than statements of historical facts, including our business strategy and plans and objectives for future operations, including our financial performance, are forward looking statements. The words " anticipate"," believe," "continue," "estimate," "expect," "intend," "may," "will" and similar expressions are intended to identify forward looking statements. We have based these forward looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short term and long term business operations and objectives, and financial needs. Forward looking statements made in this presentation include statements about the market for therapeutics targeting neurodegenerative diseases and its opportunities for our product candidates; our expectations regarding our competitive advantages; the planned development timeline of our product candidates; and characterizations of the pre - clinical and clinical trial results of our product candidates. Forward looking statements are subject to a number of risks and uncertainties and represent our views as of the date of the presentation. The future events and trends discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's final prospectus filed with the Securities and Exchange Commission on December 10, 2021. We undertake no obligation or duty to update information contained in these forward looking statements, whether as a result of new information, future events or otherwise.
3 S t r ong Pr e - clini c al Results Compl e t e d Ph a se I I a A LS study m e t pri m a r y endpoints Pa t e nt G ra nte d , 2 Pending; Orphan Designation G ra nte d (FD A & EMA) N o v e l f ormul a t ion of F D A approv e d drugs f or m ulti - t a rg e t e d approach FDA: 50 5 ( b ) ( 2 ) pathway Pipe line programs f or Par k inson's and Alzheimer's NeuroSense is a Leader in Developing Novel Combination Therapies for Highly Debilitating Neurodegenerative Diseases Inspiration I n cep tion Innovation
Phase IIa NST002 Trial Biomarker Analysis Statistically Significant Results Following Treatment with PrimeC
5 A n Inno v ative A ppro a ch Gene Therapy Str a tegy Antisense M olecular Str a tegy Antibodies Chemica l Strategy Sma l l molecu l es Cel l B a s ed St r ate g y Cel l an d Gene therapies Combine d Thera p e u ti c Strategy Targeting M ult i pl e Pathways ALS Drug s in Tria ls
6 Experienced Leadership H e a d o f Scie n tif ic Progra m Shira n Zimr i , PhD C MO Fere n c Tr a cik , MD C EO , Board M e mber Alo n B e n - Noon C h airm a n of t h e Board M a rk Le u chtenberger C FO O r Eisenberg Niva R usse k - B l u m , PhD VP Disco v e ry & IP G e n e rator VP B D Ne d ir a S a lzman H e a d o f A L S P rogram Av it a l Pushett
7 Scientific Adviso r y Boa r d P r of. Jerem y S h e f ne r ( Cha i r) • Senior VP at the Barrow Neurological Institute • C h a i r o f t h e D e p a r t m e n t o f N e ur olog y Dr. Jins y A n d rews • As s o c i a t e P r o fe sso r o f N e ur olog y , D i v i s i o n of Neuromuscular Medicine, Columbia University • Director of Neuromuscular Clinical Trials Prof . M e r i t Cu d kow i c z • C h ie f o f N e ur olog y a t Ma ss G e n e r a l a n d D i r e c t o r , S e a n M . H e a l e y & AM G C e n t e r f o r A L S • P r o fe sso r o f N e ur olog y a t H a r v a rd Me d i c a l S c h oo l Dr. Je f f e ry R o se n f e ld • Professor of Neurology and Associate Chairman of Neurology at Loma L i n d a U n i v e r s i t y S c h oo l o f Me d i c i n e • Medical Director of Center for Restorative Neurology at Loma Linda University Prof . Or l a Ha r di m a n • Head of Academic Unit of Neurology at Trinity College Dublin and Consultant Neurologist at Beaumont • Co - Chair of the European Consortium to Cure ALS and Chair o f t h e S c i e n t ific C o mmi tt e e o f ENC A L S
8 NeuroS e ns e ’ s De v el o p men t Pipel ine ALS: Amyotrophic Lateral Sclerosis, AD: Alzheimer's Disease, PD: Parkinson’s Disease • C omple t e Toxicological Stud y • Init i at e Pharma co k i n e ti c S tu d y • Init i at e Phase I I b in H 1 ‘ 22 • Init i at e P h a s e I I I in H 2 ‘ 23 • C omple t e Pr e - cli n ical Studie s A h e a d o f P la n n e d P h a s e I / II • C omple t e P r e - C li n ical Studie s A h e a d of Phase I / II
9 AL S in Nu m bers ~24% Gr o wt h i n P a tien ts b y 2 0 40 i n the U S a nd EU ALS i s a n incur a bl e n e urodegen e rative dise a s e ca u sin g c o mpl e te paralysis and ultimately death within 2 - 5 years from diagnosis >$1B A n n u a l burden i n the U S a lone + 5 , 00 0 1 P eo p l e a re d i a gnos ed wit h ALS e a c h y e a r (US) > 80 , 00 0 2 A L S P a tien ts i n Ne u ro S en s e ’ s pl a n n e d target mark e t 2 3 1. ALS - Amyotrophic Lateral Sclerosis, Johns Hopkins Medicine 2. Projected increase in amyotrophic lateral sclerosis from 2015 to 2040, Nature Communications, 2016 3. Cost of illness for neuromuscular diseases in the United States, Muscle & Nerve, 2013
10 The People Behind T he Num b ers Oct. 2016
11 Current Treatments Show Limited Efficacy Phase 3 C l ini c a l tri a l s i n th e past 1 5 yea r s have failed , w e belie v e , due mai nl y to: A N E W APPROA C H WA S N E E DED A Combined Therapeutic Strategy Targeting Multiple Pathways Single Target - Aiming for only one target in complex di s e a ses wit h m u l tipl e m e chani s ms Current Treatments Two F D A a p p r o ved dru g s, Ri l u zole a n d Ed a r a v o n e , both k n o w n t o hav e mild eff ect on pro l on g ing l i f es p a n o r i m p r o v i n g patient s ’ qu a l ity o f l i f e a nd independence
12 NeuroSense ' s Lea d Cand i date : P r imeC Two Compoun ds - One Po t ent i al ly Po w erfu l Outcome N e u r oSense ’ s F l a g ship Tr e a t ment A novel formulation , consisting of specific doses of two FDA - approved drugs, Ciprofloxacin & Celecoxib, designed to work synergistically on more than one target : • Re g ul a ti n g microRNA synth esis • Affect i n g ir o n accumul a t ion • Reduci n g neuro i n f l a m m ation 1. Management estimate $ 3. 2 B A n n u a l mark e t potential 1
13 Prim e C – Mechan i sm o f A c tion PrimeC is a novel formulation of : Celecoxib - an NSAID that inhibits COX - 2 enzyme, reducing inflammatory processes, glutamate excitotoxicity and oxidative stress, among others Ciprofloxacin - a fluoroquinolone family member, inducing Dicer activity, regulating microRNA synthesis and reducing iron accumulation
14 P r e - Clinic al Results in a K e y A nima l Model 1. Efficacy of Ciprofloxacin/Celecoxib combination in zebrafish models of amyotrophic lateral sclerosis, Annals of Clinical and Translational Neurology, 2020. Pr i m e C im p rove d loco m o tor and cel l ular def i cits of ALS zebrafish models, indicating a neuroprotective effect 1 Pr i meC tre a t m ent: x Improved motor performance of both SOD1 and TDP - 43, widely accepted models, by 84% and 110% respectively x Recovered impa i r e d motor n e u r o n s morp h ol ogy x Recovered a bnormal n e u r o m u scul a r j u n cti o n str u ct u re x Preserve d t h e r a mifi e d morp h ol og y o f m i c r o g l ia ce ll s
15 Pre - Clinical Results in Zebrafish, a Key Animal Model for ALS: 1 . I m p r o ved mot o r perf o rm a nc e 2 . Rec o ve r e d ne u r o na l struct u re Efficacy of Ciprofloxacin/Celecoxib combination in zebrafish models of amyotrophic lateral sclerosis, Annals of Clinical and Translational Neurology, 2020 *mSOD1 - Mutation in sod1 gene is prevalent in ALS
16 Phase IIa Trial Design P r o f . V i v ia n D r or y Phas e IIa NS T 00 2 : Te l A v i v Sour a s k y Me d i c a l Ce n ter Safety Blood test, electrocardiogram ( E C G), u r e a , vital sig n s, a dv e rs e e v e n ts (AE) Efficacy AL S FR S - R - Revis ed A LS F u n ction a l R a tin g S c a le – 0 - 48 FV C - Forc e d Vit a l Capacity Biomarkers E x amination o f k ey el e me n t s for A LS di a g n osi s a s w e ll a s PrimeC me c h a n ism o f a ction NST002 15 patients , 12 months dosing, clinic visit every 3 month s , p h one vi s it eve ry 1 . 5 months
17 * P oo l e d R e so u r ce O pe n - A cc es s ALS C l inical T r ials D ata base All patients completing the trial have opted to continue into an extension study with PrimeC Exploratory Endpoint: PrimeC vs. PRO - ACT* (matched) The tr i al w a s co n d u cted with an i n t erm e diate fo r mu l ation and dose Pr i meC Red u ce d th e Rat e of Decline
18 Phase IIa Clinical Trial: PrimeC intermediate formulation Primary endpoint met, exploratory endpoints showed positive results with PrimeC x Reduced Functional and Respiratory Deterioration x Si g ni f icant changes i n AL S - re l ate d bi o mark e rs x Well Tolerated, No Drug Related SAEs
Phase IIa AL S Bioma r ker s : Stage I: Case study experiment: Analysis of ALS pathology – healthy vs ALS blood samples Stage II: NST002 clinical study: Assessing the Effect of PrimeC on Key Biomarkers
*All measurements of exosome protein are in ng/ml Stage I*: Case Study Results of ALS Biomarkers in Blood Samples Im paired Aut o pha g y L yso s omal D y sfunct ion T D P - 4 3 Acc u m u lat ion m i RN A D y s r egu lat ion Ir o n Acc u m u lat ion Ne u r o infl a mma tion
Stage II*: Phase IIa Trial Biomarker Analysis *All measurem e n t s a r e in n g/ml Ne u r o infl a mma tion Im paired Aut o pha g y T D P - 4 3 Acc u m u lat ion L yso s omal D y sfunct ion
23 The biological activity observed in TDP - 43 levels may serve to indicate clinical outcomes, as can be seen from the relative correlation between the reduction in TDP - 43 levels and slower deterioration in ALSFRS - R . Correlation Between Biological Activity and Clinical Outcome
24 Planned Development Timeline • Pharmacokinetic study • ALS Phase IIb study initiation Expected: • 9 0 d a y T o xicity s tudy c o m p le ti o n • • AD Pre - clinical studies completion PD Pre - clinical studies completion • ALS Phase IIb Top - Line results • ALS End of Phase II meeting • ALS Phase III initiation AD PD H 1 / 20 2 2 H 2 / 20 2 2 H 1 / 20 2 3 H 2 / 20 2 3 Achieved: x 21 days Tox study completed x FDA IND - submitted on Feb 16 x Biomarkers - 3rd stage initiated (results in May 22) x Additional patent in Australia ; Patent allowance in Canada and Europe ALS
25 Hig h Leve l Gantt Q 1 Q 2 2022 Q 3 Q 4 Q 1 Q 2 2023 Q 3 Q 4 Dis c o ve r y R & D a ctivi tie s (Bi o markers A D / PD) 90 day s T o x St u dy PK Study Po t e n tia l Po C c l inic a l st u die s f o r A D a n d PD PK B a t c h . I N D Su b. I RB Sub. Ph I I Bat c h. T op - L in e E n d o f P h I I Results meeting Ph II I I n i t i ati on AL S P h aseI I b C l inic a l Tri al PhaseIIb - flexible design, could turn into a Pivotal study for approval , pending the changing regulatory environment R & D a ctivi tie s (Bi o markers A D / PD)
26 NRS N – Highlight s Su m mary x Novel formulation addresses multiple targets in a synergistic manner x Promising Phase 2a efficacy results x Statistically significant biomarkers data which corelates to meaningful clinical effect x Patents granted and additional IP coverage (valid till 2038) x Funded expected until completion of Phase 2b ALS study (Q2 2023) x Strong pipeline with short, mid and long term developments in big market indications
27 Fu n Facts : Managemen t Team 66% o f B o a r d m e mbers a r e US based w i t h v a st experienc e in B i otech p u b l ic c o m p a nies 50% o f N e u ro S e n se B o a rd M e m bers a r e Women < 70% o f N e u r o Sens e t e a m a re Women
28 THAN K YOU! For more information: www.NeuroSense - tx.com i n f o@Neu r oSen s e - tx . c om
Exhibit 99.2
NeuroSense Therapeutics to Participate in the 2022 Virtual Growth Conference Presented by Maxim Group LLC and hosted by M-Vest on March 28th – 30th from 9:00 a.m. - 5:00 p.m. EDT
CAMBRIDGE, Mass., March 15, 2022 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, announced today that the company's CEO, Alon Ben-Noon, has been invited to present at the 2022 Virtual Growth Conference, presented by Maxim Group LLC and hosted by M-Vest, on March 28th - 30th from 9:00 a.m. - 5:00 p.m. EDT.
Mr. Ben-Noon will be presenting during the fireside chat entitled "NeuroSense – Novel Approach to Tackle ALS on Multiple Fronts" on Wednesday, March 30, at 09:30am EDT.
During this virtual conference, investors will hear from executives from a wide range of sectors including Biotech, Clean Energy, Electric Vehicles, Financial Services, Fintech & REITS, Gaming & Entertainment, Healthcare, Healthcare IT, Infrastructure, Shipping and Technology/ Media/Telecom. The conference will feature company presentations, fireside chats, roundtable discussions, and live Q&A with CEOs moderated by Maxim Research Analysts.
This conference will be live on Maxim's M-Vest platform. To attend, just sign up to become an M-Vest member by clicking here and click here to reserve your seat.
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 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, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
NeuroSense completed a Phase 2a clinical study with 15 ALS patients in 2021. In this study, PrimeC was given in an intermediate formulation for 12 months to all of the patients. The study results showed meaningful clinical outcomes along with ALS related biological markers that were significantly changed, indicating a biological activity of PrimeC. NeuroSense plans to initiate a Phase 2b study, double-blind, placebo controlled, multicentered in Israel and the US in the first half of 2022 to evaluate the final formulation of PrimeC. PrimeC is a novel extended-release formulation composed of unique doses of two FDA-approved drugs, which aim to synergistically inhibit the progression of ALS. PrimeC has received orphan drug status from the FDA and EMA.
In addition, NeuroSense has recently announced the third stage of its collaboration with Massachusetts General Hospital in Boston on novel Neuron-Derived Exosomes (NDEs) to determine further the biological changes in ALS related pathologies and the effect of PrimeC on the relevant targets.
NeuroSense is also advancing programs in Alzheimer's disease and Parkinson's disease, and is aiming to initiate clinical studies in these indications in the first half of 2023.
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)9 953 1146