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SciSparc details autism and Tourette drug progress

SciSparc Ltd. (SPRC), through its majority-owned subsidiary NeuroThera Labs, reports operational progress in two key clinical programs.

(Neutral)
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

SciSparc Ltd. (SPRC), through its majority-owned subsidiary NeuroThera Labs, reports operational progress in two key clinical programs. Enrollment in the SCI-210 autism spectrum disorder trial has reached 26 children toward a planned total of 60 in a double-blind, randomized, placebo-controlled study at Soroka Medical Center in Israel, with each participant receiving treatment over 20 weeks. SCI-210 combines cannabidiol (CBD) with CannAmide, a Palmitoylethanolamide-based formulation, and is being evaluated against CBD monotherapy using endpoints such as the ABC-C questionnaire and CGI-I assessment.

NeuroThera is also pursuing FDA Orphan Drug Designation for SCI-110, its cannabinoid-based candidate for adults with Tourette Syndrome, and has engaged U.S. government and public affairs firm RK Strategies to support this regulatory path and U.S. stakeholder engagement. SCI-110, now in a Phase IIb program across three academic centers in the United States, Germany and Israel, previously showed an average 21% tic reduction in a Phase IIa study, providing early clinical support for further development.

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Filing Explained

Form 6-K is an interim report for a foreign private issuer; here, SciSparc furnished two press releases through it. The company states that this report is incorporated by reference into its listed F-3 and S-8 registration statements, making the report part of those filings unless later superseded.

SCI-210 trial enrollment 26 children Enrolled so far toward 60 planned in the autism spectrum disorder trial
Planned SCI-210 sample size 60 children Target enrollment for the double-blind, randomized, placebo-controlled autism trial
SCI-210 treatment duration 20 weeks Each enrolled child in the autism spectrum disorder trial receives treatment over this period
SCI-110 Phase IIa tic reduction 21% Average tic reduction in adults with Tourette Syndrome measured by the Yale Global Tic Severity Scale
U.S. rare disease threshold for Orphan Drug Designation Fewer than 200,000 individuals Maximum affected population in the United States for conditions qualifying for FDA Orphan Drug Designation
SCI-110 Phase IIb trial sites 3 centers Yale Child Study Center, Hannover Medical School, and Tel Aviv Sourasky Medical Center
double-blind, randomized, placebo-controlled medical
"The clinical trial ... is a double-blind, randomized, placebo-controlled study"
A double-blind, randomized, placebo-controlled study is a medical test where participants are randomly assigned to receive either the experimental treatment or an inactive substitute (placebo), and neither the participants nor the researchers know who got which until the study ends. Like a blind taste test, this setup reduces bias and chance results, so investors can have greater confidence that reported effects reflect the treatment itself rather than expectations or selection quirks.
Orphan Drug Designation regulatory
"it is pursuing U.S. Food and Drug Administration ("FDA") Orphan Drug Designation"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
Aberrant Behavior Checklist-Community (ABC-C) medical
"primary efficacy endpoints include the Aberrant Behavior Checklist-Community (ABC-C)"
Clinical Global Impressions-Improvement (CGI-I) medical
"and the Clinical Global Impressions-Improvement (CGI-I) assessment conducted"
Palmitoylethanolamide medical
"CannAmide™, NeuroThera’s Palmitoylethanolamide-based proprietary formulation"
Palmitoylethanolamide (PEA) is a naturally occurring fatty molecule produced in the body and sold as a supplement or experimental therapy for reducing pain and inflammation; think of it as a built‑in calming signal that helps quiet irritated tissues. Investors watch PEA because its potential medical benefits, regulatory path (supplement vs. drug), and clinical evidence drive market demand, pricing and the risk/reward of companies developing or selling PEA-based products — similar to how a promising ingredient can change the fortunes of a consumer brand.
Phase IIb program medical
"advanced SCI-110 into the next stage of clinical development with the initiation of its Phase IIb program"

FAQ

What clinical progress did SciSparc (SPRC) report for the SCI-210 autism trial?

SciSparc reported that 26 children have been enrolled in the SCI-210 autism spectrum disorder trial out of a planned 60, in a 20-week double-blind, randomized, placebo-controlled study at Soroka Medical Center in Israel.

What is SCI-210 in SciSparc’s (SPRC) pipeline and how is it being tested?

SCI-210 is a proprietary combination of cannabidiol (CBD) and CannAmide, a Palmitoylethanolamide-based formulation, being tested versus CBD monotherapy in children with autism using endpoints including the ABC-C questionnaire and CGI-I assessment over 20 weeks.

What regulatory step is NeuroThera, SciSparc’s subsidiary, taking for SCI-110 for Tourette Syndrome?

NeuroThera is pursuing FDA Orphan Drug Designation for SCI-110, its drug candidate for adults with Tourette Syndrome, a rare condition that may qualify if it affects fewer than 200,000 individuals in the United States.

What prior efficacy data support SciSparc’s SCI-110 program for Tourette Syndrome?

In a Phase IIa study, SCI-110 achieved an average 21% tic reduction across the study population, measured by the Yale Global Tic Severity Scale Total Tic Score, providing early clinical support for continued development.

Where is SciSparc’s Phase IIb program for SCI-110 being conducted?

The Phase IIb program for SCI-110 is underway at three academic centers: the Yale Child Study Center in New Haven, USA; Hannover Medical School in Germany; and Tel Aviv Sourasky Medical Center in Israel.

What role does RK Strategies play in SciSparc’s SCI-110 development?

NeuroThera engaged RK Strategies, a U.S. government and public affairs firm, to strengthen its visibility with federal stakeholders, highlight the public-health importance of new adult Tourette Syndrome treatments, and support a policy environment for long-term market access.

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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 September 2026

 

Commission File Number: 001-38041

 

SCISPARC LTD.

(Translation of registrant’s name into English)

 

20 Raul Wallenberg Street, Tower A,

Tel Aviv 6971916 Israel

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

Form 20-F ☒     Form 40-F ☐

 

 

 

 

 

CONTENTS

 

On August 31, 2026, SciSparc Ltd. (the “Company”) issued a press release titled “SciSparc: Subsidiary NeuroThera Labs Achieves Significant Enrollment Momentum in SCI-210 Autism Clinical Trial.” On September 2, 2026, the Company issued a press release titled “SciSparc: Subsidiary NeuroThera Labs Pursues FDA Orphan Drug Designation For Adult Tourette Syndrome Drug; Engages Government and Public Affairs Firm RK Strategies.” Copies of these press releases are furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively, to this Report of Foreign Private Issuer on Form 6-K (this “Report”) and is incorporated by reference herein.

 

This Report is incorporated by reference into the Company’s registration statements on Form F-3 (File Nos. 333-286099333-275305333-269839333-266047333-248670333-255408333-293167 and 333-293533) and on Form S-8 (File Nos. 333-278437333-225773333-286791 and 333-292952) filed with the Securities and Exchange Commission to be a part thereof from the date on which this Report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished. 

 

 1 

 

 

EXHIBIT INDEX

 

Exhibit No.   Description
99.1   Press release issued by SciSparc Ltd. titled “SciSparc: Subsidiary NeuroThera Labs Achieves Significant Enrollment Momentum in SCI-210 Autism Clinical Trial.”
99.2   Press release issued by SciSparc Ltd. titled “SciSparc: Subsidiary NeuroThera Labs Pursues FDA Orphan Drug Designation For Adult Tourette Syndrome Drug; Engages Government and Public Affairs Firm RK Strategies.”

 

 2 

 

 

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.

 

  SCISPARC LTD.
     
  By: /s/ Oz Adler
  Name:  Oz Adler
  Title: Chief Executive Officer and Chief Financial Officer

 

Date: September 2, 2026

 

 3 

Exhibit 99.1

 

 

 

SciSparc: Subsidiary NeuroThera Labs Achieves Significant Enrollment Momentum in SCI-210 Autism Clinical Trial

 

TEL AVIV, Israel, Aug. 31, 2026 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), today announced that NeuroThera Labs Inc. (TSXV: NTLX) ("NeuroThera"), a clinical-stage pharmaceutical company focused on developing novel treatments for central nervous system disorders, continued advancement in participant enrollment for the clinical trial assessing NeuroThera’s innovative SCI-210 treatment for symptoms associated with autism spectrum disorder (“ASD”).

 

The clinical trial, conducted at Soroka Medical Center in Israel, is a double-blind, randomized, placebo-controlled study evaluating the safety and efficacy of SCI-210 in children diagnosed with ASD. To date, 26 children have been enrolled, marking strong progress toward the planned total of 60 children between the ages of five and 18, each of whom will receive treatment over a 20-week period.

 

SCI-210 is an innovative proprietary combination of cannabidiol (“CBD”) and CannAmide™, NeuroThera’s Palmitoylethanolamide-based proprietary formulation. The treatment is being assessed for its ability to alleviate symptoms associated with ASD and to determine whether the dual-compound approach offers advantages beyond CBD monotherapy.

 

The study is designed to evaluate the efficacy and safety of SCI-210 compared with CBD monotherapy. The trial’s primary efficacy endpoints include the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire, the Clinical Global Impressions-Improvement (CGI-I) assessment conducted by a clinician, and determination of the optimal therapeutic dose.

 

The ongoing clinical trial is a key element of NeuroThera’s program for SCI-210 and reflects NeuroThera’s broader commitment to advancing innovative treatments for neurological and neurodevelopmental conditions. The study was designed in collaboration with the National Autism Research Center, a leading authority on autism research in Israel.

 

Subject to the successful completion of the clinical development program and receipt of applicable regulatory approvals, NeuroThera intends to pursue the commercialization of SCI-210, initially in Israel and subsequently in additional markets.

 

About SciSparc Ltd. (Nasdaq: SPRC):

 

The Company, through its subsidiary NeuroThera, engages in clinical-stage pharmaceutical developments. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company, together with its majority-owned subsidiary NeuroThera, is currently engaged in the following drug development programs based on THC and/or non-psychoactive CBD: SCI-110 for the treatment of Tourette syndrome, for the treatment of Alzheimer's disease and agitation; and SCI- 210 for the treatment of autism spectrum disorder and status epilepticus. The Company, through NeuroThera, also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seed oil-based products on the Amazon.com Marketplace.

 

   

 

 

About NeuroThera Labs Inc.

 

NeuroThera is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions through collaborations and innovative combinations.

 

Forward-Looking Statements:

 

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc uses forward-looking statements when it discusses t the continued progress and timing of participant enrollment in NeuroThera's clinical trial of SCI-210, including NeuroThera's ability to enroll the planned total of 60 children; the design, conduct, duration and completion of the clinical trial, including the 20-week treatment period; the potential of SCI-210 to alleviate symptoms associated with autism spectrum disorder; whether the combination of CBD and CannAmide™ offers advantages over CBD monotherapy; the ability of the trial to demonstrate the efficacy and safety of SCI-210, to meet its primary efficacy endpoints and to determine an optimal therapeutic dose; NeuroThera's broader development plans for SCI-210 and other treatments for neurological and neurodevelopmental conditions; and NeuroThera's intention to pursue regulatory approval and commercialization of SCI-210, initially in Israel and subsequently in additional markets.

The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in SciSparc’s Annual Report on Form 20-F, filed with the SEC on April 29, 2026, as amended on August 19, 2026, and in subsequent filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

 

Investor Contact:


IR@scisparc.com
Tel: +972-3-6167055

 

   

 

Exhibit 99.2

 

 

 

SciSparc: Subsidiary NeuroThera Labs Pursues FDA Orphan Drug Designation For Adult Tourette Syndrome Drug; Engages Government and Public Affairs Firm RK Strategies

 

This strategic engagement is designed to strengthen NeuroThera’s U.S. market position, visibility among key U.S. federal stakeholders, reinforce the clinical and public-health importance of advancing new treatment options for adult Tourette Syndrome

 

TEL AVIV, Israel, Sept. 02, 2026 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), today announced that its subsidiary, NeuroThera Labs Inc. (TSXV: NTLX) ("NeuroThera"), a clinical-stage pharmaceutical company focused on developing novel treatments for central nervous system disorders, today announced that it is pursuing U.S. Food and Drug Administration (“FDA”) Orphan Drug Designation covering SCI-110, its drug candidate for the treatment adults with Tourette Syndrome (“TS”), a rare condition that may qualify for Orphan Drug Designation.

 

To support and accelerate this regulatory pathway, NeuroThera has engaged RK Strategies, Inc. (“RK Strategies”), a U.S. government and public affairs consulting and lobbying firm focused primarily on healthcare issues.

 

This strategic engagement is designed to strengthen NeuroThera’s visibility among key federal stakeholders, reinforce the clinical and public-health importance of advancing new treatment options for adult TS, and help shape a policy environment that supports long-term market access and commercial success.  FDA Orphan Drug Designation is a meaningful regulatory and commercial opportunity for NeuroThera. This status is reserved for investigational therapies targeting rare diseases or conditions affecting fewer than 200,000 individuals in the United States. For a company advancing a first-in-class treatment for adult TS, the designation, if granted, can potentially materially strengthen the product’s market profile.

 

SCI-110 is NeuroThera’s proprietary cannabinoid-based therapeutic candidate uniquely formulated to combine dronabinol with palmitoylethanolamide (PEA) in a single oral dosage form. SCI-110 is designed to address a significant unmet need in adult TS by targeting both tic reduction and associated comorbid symptoms, while aiming to minimize side effects. NeuroThera recently advanced SCI-110 into the next stage of clinical development with the initiation of its Phase IIb program, now underway at three leading academic centers: the Yale Child Study Center in New Haven, Connecticut, USA; Hannover Medical School, Hannover, Germany; and Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. This global footprint underscores the continuous growing clinical interest in cannabinoid-based approaches for neuropsychiatric disorders and reflects NeuroThera’s commitment to rigorous, multinational evaluation.

 

The Phase IIb program builds on Phase IIa results in which SCI-110 achieved an average tic reduction of 21% across the study population, as measured by the Yale Global Tic Severity Scale Total Tic Score. These findings provide early clinical validation of the drug’s mechanism and support its potential to become a differentiated therapeutic option in a market with limited effective treatments.

 

Together, the advancing clinical program, multinational trial execution, and potential efficacy signals position SCI-110 as a compelling late-stage asset with meaningful value-creation potential as NeuroThera progresses toward regulatory milestones and future commercialization.

 

RK Strategies is a government and public affairs consulting and lobbying firm founded in 2017 by Ryan Kane. The firm advises private and publicly traded companies in healthcare, pharmaceuticals, preparedness, biodefense, defense and technology, with a focus on engagement before U.S. policymakers and other stakeholders. RK Strategies’ work has included advising elected officials and supporting policy outcomes across healthcare preparedness and related areas.

 

   

 

 

About SciSparc Ltd. (Nasdaq: SPRC):

 

The Company, through its majority-owned subsidiary NeuroThera, engages in clinical-stage pharmaceutical developments. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company, together with its majority-owned subsidiary NeuroThera, is currently engaged in the following drug development programs based on THC and/or non-psychoactive CBD: SCI-110 for the treatment of Tourette syndrome, for the treatment of Alzheimer's disease and agitation; and SCI-210 for the treatment of autism spectrum disorder and status epilepticus. The Company, through NeuroThera, also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seed oil-based products on the Amazon.com Marketplace.

 

About NeuroThera Labs Inc.

 

NeuroThera is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions through collaborations and innovative combinations.

 

Forward-Looking Statements:

 

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc uses forward-looking statements when it discusses NeuroThera’s pursuit of Orphan Drug Designation for NeuroThera’s SCI-110; that the strategic engagement with RK Strategies is designed to strengthen NeuroThera’s visibility among key federal stakeholders, reinforce the clinical and public-health importance of advancing new treatment options for adult TS, and help shape a policy environment that supports long-term market access and commercial success; that Orphan Drug Designation can potentially materially strengthen the product’s market profile; the potential benefits, advantages and capabilities of SCI-110; significant unmet need in adult TS; that global footprint underscores the continuous growing clinical interest in cannabinoid-based approaches for neuropsychiatric disorders; SCI-110’s potential to become a differentiated therapeutic option in a market with limited effective treatments; and that the advancing clinical program, multinational trial execution, and potential efficacy signals position SCI-110 as a compelling late-stage asset with meaningful value-creation potential as NeuroThera progresses toward regulatory milestones and future commercialization. Because such statements deal with future events and are based on SciSparc’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in SciSparc’s Annual Report on Form 20-F, filed with the SEC on April 29, 2026, as amended on August 19, 2026, and in subsequent filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

 

Investor Contact:

 

IR@scisparc.com

Tel: +972-3-6167055

 

   

 

Filing Exhibits & Attachments

2 documents