Tonabersat

Phase 1 clinical data to be released in conjunction with Investor Day San Diego, California--(News - October 19, 2023) - Skye Bioscience, Inc. (OTCQB: SKYED) ("Skye" or the "Company"), a pharmaceutical company developing drugs targeting the endocannabinoid system, initially through modulation of the CB1 receptor, to address diseases including glaucoma and metabolic conditions, announces that it will host a virtual Investor Day, called "CB1 Axis: Unlocking the Pharmaceutical Potential of the Endocannabinoid System", on Wednesday, October 25, 2023 at 8:00am ET. To register, click here. In conjunction with this event, Skye will also release its Phase 1 clinical data. The event will feature Brian Levy, O.D. (former CMO, Aerie and Bausch & Lomb), Glenwood Gum, Ph.D. (Pharmaron), and Sameh Mosaed, M.D., Ph.D. (UC Irvine), who will provide an overview of the current glaucoma commercial landscape, drug development pipeline, and perspective on the historical challenges to achieving CB1-targeting therapeutics for the treatment of glaucoma. Skye leadership will provide broad insight into SBI-100 Ophthalmic Emulsion, its CB1 agonist being developed to potentially treat glaucoma, including a nonclinical data overview, clinical data from the company's recently completed Phase 1 study, a Phase 2 clinical update, and an outline of the glaucoma market opportunity and Skye's positioning strategy. A live question and answer session will follow the formal presentations. About Brian Levy, O.D. Dr. Brian Levy, CEO of InflammX Therapeutics, leads the development of Xiflam for dry AMD and diabetic eye/kidney diseases, now in a Phase 2 trial with NIH's DRCR Retinal Network. Formerly CMO at Aerie Pharmaceuticals, he pioneered rho kinase inhibition treatments, including the approvals of Rhopressa® and Rocklatan®. As VP of R&D at Bausch & Lomb for 15 years, he oversaw approvals of Retisert, Zylet, and Besivance. A seasoned ophthalmologist with over 50 publications, Levy holds degrees from UC Berkeley and University of Waterloo. About Glenwood Gum, Ph.D. Dr. Gum has 40+ years' experience in ophthalmology research and development in an academic and industry setting. As the Sr. Director of Ophthalmology at Pharmaron, he's advanced ocular studies, especially using the glaucomatous beagle model. His collaboration with renowned pharmaceutical companies has led to breakthroughs in beta blockers, cannabinoids, and prostaglandins. About Sameh Mosaed, M.D., Ph.D. Dr. Sameh Mosaed, MD, is a Professor of Ophthalmology and Chief of Glaucoma at UC Irvine's Gavin Herbert Eye Institute. She directs the glaucoma fellowship training program and is renowned for her minimally invasive glaucoma surgery expertise. Dr. Mosaed is credited with over 50 published papers and numerous textbook chapters. About SBI-100 Ophthalmic Emulsion Skye's SBI-100 OE possesses a novel molecular structure and nanoemulsion formulation designed to enable effective topical delivery and better penetration of a CB1 agonist into ocular tissue. In preclinical studies involving three different species, the drug resulted in enhanced therapeutic efficacy and duration of response in lowering IOP, comparing favorably to the standard of care for treating glaucoma. About Skye Bioscience Skye is focused on unlocking the pharmaceutical potential of the endocannabinoid system to treat diseases with inflammatory, fibrotic, and metabolic processes. Backed by leading life science venture investors, Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with significant clinical and commercial differentiation. Nimacimab, a negative allosteric modulating antibody, inhibits peripheral CB1 with unprecedented safety and tolerability. A Phase 2 cardio-metabolic related indication study is expected to start in Q1 2024. Skye is also evaluating potential development paths for nimacimab related to obesity and weight loss. SBI-100 Ophthalmic Emulsion is a CB1 agonist that is a potential treatment for glaucoma and is expected to start a Phase 2 clinical trial in Q4 2023. For more information, please visit: . CONTACT Investor Relations Email: ir@skyebioscience.com Phone: (858) 410-0266 FORWARD-LOOKING STATEMENTS This letter contains forward-looking statements, including statements regarding our product development, business strategy, the timing of clinical trials, and commercialization of cannabinoid-derived therapeutics. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. In some cases, forward-looking statements can be identified by terminology including "anticipated," "plans," "goal," "focus," "aims," "intends," "believes," "can," "could," "challenge," "predictable," "will," "would," "may" or the negative of these terms or other comparable terminology. We operate in a rapidly changing environment, and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Risk Factors section of Skye's most recent annual or quarterly report filed with the Securities and Exchange Commission. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements. To view the source version of this press release, please visit

Sarah Silbiger/Getty Images The FDA had a busy week, approving drugs, greenlighting clinical trials and other regulatory activities for Immuneering, Amylyx, Sarepta, Sanofi, Regeneron GE Healthcare and more. Here’s a look. Sept. 30 Immuneering Corporation’s IND for IMM-1-104 was given the green light for a Phase I/IIa trial for advanced RAS mutant solid tumors. Sept. 29 Amylyx’s combination of sodium phenylbutyrate and taurusodiol was approved to treat amyotrophic lateral sclerosis (ALS). It will be marketed under the brand name Relyvrio. Sarepta Therapeutics submitted a BLA to the FDA for accelerated approval of SRP-9001 (delandistrogene moxeparvovec) to treat ambulant patients with Duchenne muscular dystrophy (DMD). SRP-9001 is a gene therapy being developed in partnership with Roche. The BLA was based on the expression of SRP-9001 dystrophin protein as a surrogate endpoint that would probably predict clinical benefit. Napo Pharmaceuticals announced the FDA greenlit its Phase I trial of NP-300 for treatment of moderate-to-severe diarrhea, with or without concomitant antimicrobial therapy. GE Healthcare received FDA 510(K) clearance of its AIR Recon DL for 3D and PROPELLER imaging sequences, which are used by almost all MRI clinical procedures. InflammX Therapeutics submitted an IND Amendment to launch clinical trials with Xiflam, an oral NLRP3 inflammasome inhibitor with broad applications, but initial focus on Diabetic Macular Edema (DME), the intermediate stage of Age-related Macular Degeneration (iAMD) and the Geographic Atrophy form of AMD. InflaRx submitted an Emergency Use Authorization request for vilobelimab for the treatment of critically ill COVID-19 patients. C4 Therapeutics received the go-ahead to launch a Phase I/II trial for CFT1946 to treat BRAF-V600 mutant solid tumors. Alzamend Neuro submitted an IND application to the FDA for ALZN002, an immunotherapy to treat mild to moderate dementia of the Alzheimer’s type. Sept. 28 Sanofi and Regeneron’s Dupixent (dupilumab) was approved for adults with prurigo nodularis. Citius Pharmaceuticals submitted a BLA for denileukin diftitox, an engineered IL-2-diphtheria toxin fusion protein for persistent or recurrent cutaneous T-cell lymphoma. Celltrion USA’s Vegzelma (bevacizumab-adcd), a biosimilar to Avastin, was approved by the FDA for treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer. Pharming Group announced the FDA accepted for priority review its NDA for leniolisib to treat activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years and older. Mallinckrodt Pharmaceuticals submitted a 510(K) premarket notification application for an investigational inhaled nitric oxide delivery system for inhalation of INOmax (nitric oxide) gas. OxyNov filed a 510(k) submission with the FDA for the FreeO2 device, an oxygen therapy device. Sept. 27 Vertex Pharmaceuticals and CRISPR Therapeutics concluded discussions with the FDA, and the FDA granted exagamglogene autotemcel a rolling review for the potential treatment of sickle cell disease and transfusion-dependent beta thalassemia. Blue Earth Diagnostics announced the FDA accepted its NDA application for 19F-rhPSMA-7.3, a radiohybrid Prostate-Specific Membrane Antigen-targeted PET imaging agent. Bellerophon Therapeutics reported the FDA accepted its proposal to reduce the study size of its ongoing REBUILD Phase III trial of INOpulase for fibrotic Interstitial Lung Disease. The new study size will be 140 patients. Ayala Pharmaceuticals was granted Fast Track designation for AL102 for treatment of progressing desmoid tumors. Sept. 26 Atea Pharmaceuticals announced the FDA granted Fast Track Designation to AT-752, an oral therapy for dengue virus infection. Pfizer and BioNTech reported they had completed an Emergency Use Authorization submission to the FDA for a 10-microgram dose of its Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for kids 5 through 11 years of age. CatalYm received the greenlight to expand its ongoing Phase II clinical program to include U.S. sites. The ongoing GDFATHER-2 program is studying visugromab in combination with an anti-PD1 antibody in advanced solid tumors that are relapsed/refractory to previous anti-PD1/PD-L1 treatment.