Autism Spectrum Disorder

SAN DIEGO, March 19, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced the publication of a study of optical genome mapping (OGM) in hereditary breast and ovarian cancer (HBOC) syndrome showing that when tumors exhibited higher overall numbers of structural variations (SVs) they tended to have more mutated genes and altered signaling pathways, which may correlate with poor prognosis, tumor progression and chemotherapy resistance. Researchers also found that OGM was able to detect chromothripsis events and novel gene fusions in cancer tissues with high accuracy, including novel gene fusions that were not detected by other methods. HBOC syndrome is estimated to cause 5-10% of all breast cancers and is commonly characterized by harmful germline mutations in the BRCA1 or BRCA2 genes. Due to limitations inherent in common methods of genome analysis, researchers have limited knowledge regarding the potential impact of structural abnormalities and SV heterogeneity in HBOC-related cancers. The study authors selected OGM for this analysis due to its ability to detect multiple classes of SVs with genome-wide coverage, high resolution and accuracy. Study authors categorized the HBOC-related breast cancer samples into two groups, SVhigh and SVlow, based on the number of SVs detected by OGM, high or low Ki-67 expression, and the number of mutated genes and altered signaling pathways. The authors noted that SVhigh samples were associated with higher Ki-67 expression and higher homologous recombination deficiency (HRD) scores, indicating that genetic alterations may have potential predictive and therapeutic significance. The SVhigh samples also showed higher numbers of chromothripsis events and novel gene fusions than the SVlow samples. Eight novel gene fusions were identified by OGM, including three that had not previously been detected by other methods of analysis. These gene fusions may be involved in drug resistance and tumor development. “We are pleased to see the publication of this study, which highlights OGM as a promising tool for detecting novel variants in HBOC-related breast cancer that have oncogenic potential. We believe the comprehensive assessment of the role SVs play in breast cancers with abnormal DNA repair functions might expand our current understanding of disease progression and precision medicine in breast cancer," commented Erik Holmlin, PhD, president and chief executive officer of Bionano. The paper is available at: About Bionano Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through OGM solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also provides diagnostic testing for patients with clinical presentations consistent with autism spectrum disorder and other neurodevelopmental disabilities. The Company also offers an industry-leading, platform-agnostic software solution, which integrates next-generation sequencing and microarray data designed to provide analysis, visualization, interpretation and reporting of copy number variants, single-nucleotide variants and absence of heterozygosity across the genome in one consolidated view. The Company additionally offers nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. For more information, visit , or . Bionano’s OGM products are for research use only and not for use in diagnostic procedures. Forward-Looking Statements of Bionano This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “may,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and utility of OGM to detect SVs in samples suspected of HBOC syndrome; and the ability and utility of OGM to detect chromothripsis events and novel gene fusions in cancer tissues with high accuracy, including novel gene fusions that were not detected by other methods. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of geopolitical and macroeconomic developments, such as recent and potential future bank failures, supply chain disruptions, global pandemics, inflation and the ongoing conflicts between Ukraine and Russia and Israel and Hamas, on our business and the global economy; general market conditions; the failure of OGM to detect SVs in samples suspected of HBOC syndrome; the failure of OGM to detect chromothripsis events and novel gene fusions in cancer tissues with high accuracy, including novel gene fusions that were not detected by other methods; study results that differ or contradict the results reported in the study referenced in this press release; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; changes in our strategic and commercial plans; our need and ability to obtain sufficient financing to fund our strategic plans and commercialization efforts, our ability to effectively manage our uses of cash, and our ability to continue as a “going concern”; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2023 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. CONTACTS Company Contact: Erik Holmlin, CEO Bionano Genomics, Inc. +1 (858) 888-7610 eholmlin@bionano.com Investor Relations: David Holmes Gilmartin Group +1 (858) 888-7625 IR@bionano.com

TEL AVIV, Israel, March 18, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, today announced that it has been granted a patent for its core-technology, the combination of cannabinoids and n-acylethanolamines, by the Canadian Intellectual Property Office (the “Patent”). The Patent aligns seamlessly with the Company's proprietary technology and is designed to enhance the safety of cannabinoids by using low dosages of active components while maintaining their therapeutic benefits. This patent grant adds to the patent portfolio of the Company, thereby supporting the innovation of SciSparc’s technologies. Oz Adler, CEO of SciSparc, commented, “With this patent, we continue to strengthen our global intellectual property rights. SciSparc is a unique company in the cannabis space. We believe we are building value for our investors, as the Company continues to develop technologies for the treatment of central nervous system disorders." The Patent covers the compositions and methods for potentiating therapeutic effects and/or reducing the side-effects of selected cannabinoids initially discovered in the cannabis plant. The Patent was granted on account of the unique composition of cannabinoids and n-acylethanolamines and the methods for their use in preventing and treating a variety of cannabinoid-treated conditions. About SciSparc Ltd. (Nasdaq: SPRC): SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company 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; SCI-160 for the treatment of pain; and SCI- 210 for the treatment of ASD and status epilepticus. The Company also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seeds oil-based products on the Amazon.com Marketplace. 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 is using forward-looking statements when it discusses: the Company’s continued effort to strengthen its global intellectual property rights; its belief that its is building value for its inestors; and that it continues to develop technologies for the treatment of central nervous system disorders. 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 May 1, 2023, 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.comTel: +972-3-6167055

First patient has been dosed in the randomized, controlled, double blind clinical trial for Autism Spectrum Disorder in pediatric patients TEL AVIV, Israel, March 14, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, today announced that it has successfully dosed the first patient in its SCI-210 clinical trial at the Soroka Medical Center for pediatric patients who have Autism Spectrum Disorder ("ASD"). This significant milestone follows the Company's recent announcement about the successful delivery of its innovative SCI-210 treatment to the clinical trial site, enabling the commencement of dosing. SciSparc's proprietary SCI-210 treatment combines cannabidiol-rich oil (“CBD”) and CannAmide™, SciSparc’s proprietary palmitoylethanolamide-based tablets. The dosing of the first patient signifies the transition from preparatory phases to active treatment evaluation in the quest to offer a more effective and safe treatment option for ASD. "Dosing the first patient is always an exciting moment in any clinical trial. As we work to offer new hope to the patients, family members, and caretakers who are battling this disorder, we are excited to kick-off this next phase of development for SCI-210,” said Oz Adler, SciSparc's Chief Executive Officer. "We are thrilled to reach this milestone, which brings us one step closer to potentially offering a new beacon of hope for patients and families affected by ASD. We are grateful to the patients, Professor Meiri and his team involved in the clinical trial. This achievement represents a pivotal moment for SciSparc as we introduce SCI-210, an innovative cannabinoid-based treatment." The clinical trial aims to rigorously evaluate the safety, tolerability, and efficacy of SCI-210 in comparison to CBD monotherapy for the treatment of ASD. Designed as a randomized, double-blind, placebo-controlled clinical trial with cross-over, the study will span 20 weeks and enroll 60 children. The trial's primary efficacy endpoints include three rigorous assessments: the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire; the Clinical Global Impressions-Improvement (CGI-I) scale administered by healthcare professionals; and the determination of the effective therapeutic dosage. About SciSparc Ltd. (Nasdaq: SPRC): SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company 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; SCI-160 for the treatment of pain; and SCI- 210 for the treatment of ASD and status epilepticus. The Company also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seeds oil-based products on the Amazon.com Marketplace. 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 is using forward-looking statements when it discusses the aims of the SCI-210 clinical trial. 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 May 1, 2023, 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