SAN DIEGO - Skye Bioscience Inc. (NASDAQ:SKYE) has announced the discontinuation of its SBI-100 Ophthalmic Emulsion (OE) program following the failure to meet the primary endpoint in a Phase 2a clinical trial. The trial, which involved patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT), did not demonstrate a statistically significant improvement in lowering intraocular pressure (IOP) compared to placebo.
The double-masked, randomized, placebo-controlled trial included 56 patients diagnosed with POAG or OHT. Participants were treated with either 1.0% or 0.5% concentrations of SBI-100 OE, or a placebo, administered as one drop in each eye twice daily over a 14-day period. Despite the drug's safety and no early discontinuations due to adverse events, the trial did not meet the pre-set criteria for continued development of SBI-100 OE as an alternative treatment for glaucoma and ocular hypertension.
Skye's Chief Development Officer, Tu Diep, expressed gratitude to the patients and investigators involved in the study and confirmed the company's intention to publish the full data set. The company has decided to redirect all clinical development resources to its metabolic program, particularly focusing on Nimacimab, a CB1 inhibitor expected to enter a Phase 2 obesity clinical trial in the third quarter of 2024.
According to Skye's CEO and Chair, Punit Dhillon, the shift in focus aims to diversify the company's product portfolio and expand clinical and business opportunities. Nimacimab is highlighted as a potential contributor to sustainable weight loss and improved treatments for co-morbid conditions. Dhillon underlined the unique mechanism of peripheral CB1 inhibition that Nimacimab offers, which could play a role in an incretin-biased anti-obesity therapeutic landscape.
Nimacimab is described as a first-in-class humanized monoclonal antibody that inhibits CB1 signaling in the periphery, with potential applications in a range of diseases with unmet medical needs including obesity, chronic kidney disease, and metabolic dysfunction-associated steatohepatitis (MASH).
Skye Bioscience's strategic decision to halt the SBI-100 OE program and concentrate on its metabolic clinical pipeline is expected to extend the company's cash runway into 2027. This pivot is based on the results from the recent clinical trial, as stated in the press release issued by the company.
In other recent news, Skye Bioscience has been the subject of attention from both Cantor Fitzgerald and Piper Sandler. Cantor Fitzgerald initiated coverage on the company, assigning an Overweight rating and a price target of $21.00. The firm's analysis highlighted Skye Bioscience's promising pipeline, including a Phase 2 trial for nimacimab, aimed at treating obesity, and the anticipated release of top line data from the Phase 2a trial of SBI-100 Ophthalmic Emulsion for glaucoma treatment.
On a similar note, Piper Sandler raised its price target on Skye Bioscience to $20, following progress in the company's Phase IIa study evaluating the efficacy of the CB1 agonist SBI-100. The company is also preparing for a Phase II study of nimacimab in obese patients, expected to commence in mid-2024.
In tandem with these developments, Skye Bioscience recently secured $40 million in gross proceeds through a private placement deal. The funding, according to Skye's CEO, Punit Dhillon, will support the company's upcoming Phase 2 clinical trials for obesity and glaucoma. Participating investors in this private investment included Perceptive Advisors, Velan Capital, Schonfeld Strategic Advisors, and several existing Skye shareholders such as 5AM Ventures, Altium Capital, and Sphera Healthcare.
InvestingPro Insights
In light of Skye Bioscience Inc.'s recent announcement to discontinue its SBI-100 OE program, investors may be interested in how the company's financial metrics and market performance align with these developments. According to InvestingPro data, Skye's price-to-book ratio stands at 4.32 as of the last twelve months ending Q1 2024, suggesting a higher valuation compared to its book value. Despite the setback in its clinical trial, Skye has demonstrated significant market resilience with a year-to-date price total return of 302.21% and a one-year price total return of 189.8%, reflecting investor optimism about the company's potential, particularly in its pivot to the metabolic program.
From an operational perspective, Skye's cash management appears to be a strength, as an InvestingPro Tip highlights that the company holds more cash than debt on its balance sheet. This financial stability may provide the necessary buffer to weather the discontinuation of the SBI-100 OE program and support the continued development of Nimacimab. Additionally, another InvestingPro Tip indicates that while the stock has experienced considerable volatility, with a large price uptick over the last six months, analysts are cautious about the company's profitability in the short term.
For investors seeking a deeper analysis of Skye Bioscience and additional insights into its future prospects, InvestingPro offers a comprehensive set of tips, with 11 additional tips available beyond what has been shared here. To access these valuable insights, consider subscribing to InvestingPro using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. This may help investors make more informed decisions as Skye Bioscience navigates its strategic shift towards its metabolic program.
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