SKYE

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Major Earnings Reports: Key companies reporting earnings after the market close on Thursday include Micron Technology, NIKE, FedEx Corporation, Luminar Technologies, and Ouster.

Additional Earnings Releases: Other companies expected to release their earnings include CIG, HTHT, IDN, LEN, MGNX, PL, QUBT, RKDA, RWAY, SKYE, and VXRT.

Earnings Announcement: Skye Bioscience is set to release its Q4 earnings results on March 19th, with an expected EPS of -$0.28 and no revenue forecasted.

EPS Estimates: Over the past three months, there has been one downward revision in EPS estimates for Skye Bioscience, with no upward revisions noted.

Conference Call Announcement: Skye Bioscience will host a conference call on March 20, 2025, at 1:30 p.m. PT to discuss its fourth quarter and full-year financial results for 2024, with an earnings press release issued after market close.

Company Focus and Clinical Trials: Skye is developing therapeutics for obesity and metabolic disorders, currently conducting a Phase 2 clinical trial for nimacimab, which targets CB1 receptors and assesses its combination with Wegovy®.

Biotech Stocks Surge in Interest: Several biotech companies, including Vaxcyte and Maravai LifeSciences, are experiencing significant increases in search activity, indicating heightened investor interest. This surge is attributed to their innovative developments and potential market impact.

Recent Developments and Analyst Ratings: Companies like Madrigal Pharmaceuticals and Geron have received various analyst upgrades and downgrades based on recent earnings reports and clinical trial results, reflecting the volatile nature of biotech investments influenced by upcoming FDA approvals and study outcomes.

Stock Option Grant Announcement: Skye Bioscience, Inc. announced the granting of a non-qualified stock option award for 56,000 shares to two new non-executive employees as part of its 2024 Inducement Equity Incentive Plan, with an exercise price of $2.89 per share.

Company Focus and Clinical Trials: Skye is dedicated to developing therapeutics for metabolic health, currently conducting a Phase 2 clinical trial for nimacimab, an antibody targeting obesity, in combination with a GLP-1R agonist.

Skye Bioscience Participation: Skye Bioscience's CEO, Punit Dhillon, will participate in a panel at the South by Southwest (SXSW) conference on March 10, 2025, discussing future obesity management beyond GLP-1 drugs.

Company Focus and Research: Skye Bioscience is developing innovative therapies for metabolic health, including a Phase 2 clinical trial for nimacimab, an antibody targeting obesity, which is being studied in combination with a GLP-1R agonist.

Construction Sector Performance: Construction shares are lagging the market, down approximately 2.3%, with Orion Group Holdings and Comfort Systems USA leading the decline at 8.8% and 6.8%, respectively.

Market Commentary: The views expressed in the article reflect the author's opinions and do not necessarily represent those of Nasdaq, Inc.

Emerging Weight Loss Therapies: Small biotech companies are developing innovative weight loss treatments with unique mechanisms of action, such as Skye Biosciences' nimacimab, which aims to promote sustainable weight loss while preserving lean muscle mass without affecting the central nervous system.

Future Trends in Obesity Treatments: Experts predict that future weight loss therapies will focus on improved dosing frequency, reduced side effects, and enhanced efficacy, with an emphasis on body composition changes as a key metric for treatment success.

Upcoming Conferences: Skye Bioscience, Inc. will participate in several healthcare investment conferences in December, including the Evercore HealthCONx Conference and the Citi Global Healthcare Conference, with webcasts available on their website.

Focus on Metabolic Health: The company is developing nimacimab, a therapeutic for obesity that modulates G-protein coupled receptors, currently undergoing a Phase 2 clinical trial to assess its efficacy and safety.

Skye Bioscience's Drug Development: Skye Bioscience is developing nimacimab, a peripheral cannabinoid receptor 1 (CB1) inhibitor for weight loss, currently in Phase 2 FDA trials. Analysts have high expectations for the drug due to its potential benefits over existing GLP-1 agonists, particularly in reducing gastrointestinal and psychiatric side effects.

Market Potential and Risks: While nimacimab shows promise with fewer side effects compared to competitors, it may achieve lower weight loss results (around 8% after 26 weeks) than other treatments like tirzepatide. The success of nimacimab, especially in combination with Wegovy, could significantly impact Skye's stock price, but the risk remains as only a small percentage of drugs in trials receive FDA approval.

Micro-Cap Stocks Overview: Micro-cap stocks, with market capitalizations between $50 million and $300 million, can offer high returns but also pose significant risks, as demonstrated by examples like NVIDIA's massive gains and SunPower's bankruptcy.

Highlighted Companies: Three micro-cap companies are discussed: Rent the Runway is working to improve its financials amidst competition; 374Water is testing new wastewater technology in Orlando for potential revenue; and Skye Bioscience is developing a weight loss drug that could be a market disruptor if it successfully navigates FDA trials.

Clinical Data Validation: Skye Bioscience's nimacimab, a large-molecule CB1 inhibitor, shows promising safety and efficacy in weight loss compared to Novo Nordisk's small-molecule monlunabant, which has demonstrated neuropsychiatric side effects due to brain exposure.

Ongoing Trials and Future Prospects: Skye is conducting a Phase 2 trial for nimacimab in obesity, with interim results expected in Q2 2025, highlighting its potential as a safer alternative for metabolic health therapies.

Analyst Ratings: Wall Street analyst Jonathan Wolleben from JMP Securities has reiterated a Buy rating for Skye Bioscience (SKYE) with a price target of $15.00, citing the potential advantages of its lead drug candidate, nimacimab, over competitors due to its unique mechanism that may reduce safety concerns.

Stock Performance: Despite a significant drop in SKYE's stock price by 75.19% over the past six months, there is optimism among analysts, including Piper Sandler who also maintains a Buy rating with a higher price target of $20.00, suggesting a potential recovery based on upcoming trial results.

Novo Nordisk's Clinical Trial Results: Novo Nordisk announced positive results from a phase 2a trial of monlunabant, showing significant weight loss in participants compared to placebo, but investor reactions were mixed due to limited additional weight loss at higher doses.

Impact on Competitors' Stocks: Stocks of Corbus Pharmaceuticals and Skye Bioscience fell sharply following the news, as both companies are also developing weight loss drugs targeting CB1 inhibition, with analysts adjusting their price targets for Corbus amid ongoing uncertainties.

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U.S. Stock Market Performance: U.S. stocks opened lower with the Dow Jones down 50 points, while FedEx reported disappointing earnings and lowered its full-year guidance, causing a decline in its stock price.

Global Market Trends: European shares mostly fell, while Asian markets closed higher; Spain's trade deficit narrowed, and retail sales in the UK rose by 1% month-over-month in August.

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Appointment of Chief Medical Officer: Skye Bioscience has appointed Dr. Puneet S. Arora as Chief Medical Officer to lead the Phase 2 CBeyond™ obesity clinical trial for nimacimab, a novel CB1 inhibitor aimed at improving metabolic health.

Nimacimab's Potential and Background: Nimacimab is a first-in-class monoclonal antibody that inhibits CB1 signaling, showing promise in treating obesity and other metabolic diseases, with Dr. Arora bringing over 15 years of experience in clinical trials and drug development to the role.

Stock Option Grant: Skye Bioscience granted a non-qualified stock option award to a new employee for 40,000 shares at an exercise price of $5.28, as part of its 2024 Inducement Equity Incentive Plan, which is designed for new hires or those returning after a period of non-employment.

Clinical Development Focus: The company is advancing its clinical trials, including a Phase 2 trial for nimacimab, aimed at treating obesity by inhibiting CB1 receptors, and is leveraging biologic targets for developing innovative therapeutics.