SKYE

This article first appeared on GuruFocus. Release Date: August 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Skye Bioscience Inc (NASDAQ:SKYE) shareholders will receive a contingent value right entitling them to 90% of net proceeds from any monetization of Nimacimab within 12 months post-closing. The combined company, Fibrex Therapeutics, will be well-capitalized with $125 million in financing, providing a cash runway into 2029. The lead asset RXC008 has demonstrated strong preclinical efficacy, including full reversal of established fibrosis in animal models. RXC008 has a favorable safety profile with negligible systemic exposure, confirmed by a 750-fold safety margin below the IC50 for hypotension. The transaction provides Skye Bioscience Inc (NASDAQ:SKYE) shareholders with a 5.4% stake in a new pure-play fibrosis company with multiple value inflection points, including Phase 2 data expected in H2 2028. Skye Bioscience Inc (NASDAQ:SKYE) shareholders will own only approximately 5.38% of the combined company, a significant dilution of their ownership. The legacy program Nimacimab has been discontinued due to an unfavorable market landscape, requiring a substantial multi-year Phase 3 investment with no assurance of a differentiated label. The transaction is subject to multiple conditions, including shareholder approvals and court sanction, creating uncertainty about completion. RXC008's Phase 2 trial is only set to begin in Q4 2026, with top-line data not expected until H2 2028, leaving a long period of no near-term catalysts. The discontinuation of Nimacimab development may be seen as a setback for investors who supported the original pipeline, and the CVR's value is uncertain as it depends on future monetization. Warning! GuruFocus has detected 1 Warning Sign with SKYE. Is SKYE fairly valued? Test your thesis with our free DCF calculator. Q: What is the rationale behind Skye Bioscience's decision to discontinue its legacy nimacimab program and merge with Redx Pharma?A: Punit Dhillon (CEO of Skye Bioscience) explained that the decision was driven by a capital allocation strategy rather than a conclusion about nimacimab's biology. The anti-obesity landscape has shifted rapidly with oral GLP-1 options and highly efficacious combination/triple agonists advancing. Nimacimab would require a dose of at least 600 mg with an injection volume of roughly 6 mL weekly, which falls outside the convenience window, and would need substantial multi-year Phase 3 investment with no assurance of a differentiated label. Sky shareholders will receive a contingent value right entitling them to 90% of net cash proceeds from any monetization of nimacimab within 12 months post-closing, plus a 5.4% stake in the combined company. Q: What is the new combined company's focus and what are its lead assets?A: Lisa Anson (CEO of Redx Pharma) stated that the combined company will be named Fibrex Therapeutics and will focus on developing Redx's fibrosis portfolio. The lead asset is RXC008, a GI-restricted Pan-ROC inhibitor entering Phase 2 for fibrostenotic Crohn's disease. The pipeline also includes a preclinical discoidin domain receptor (DDR) inhibitor program and Zolacidil (RXC007), a selective ROCK2 inhibitor that completed a successful Phase 2 study in idiopathic pulmonary fibrosis. Q: What is the expected ownership structure of the combined company post-transaction?A: Punit Dhillon detailed that pre-transaction Sky equity holders are expected to own approximately 5.38% of the combined company, pre-transaction Redx equity holders approximately 59.75%, and investors participating in the concurrent $125 million financing approximately 34.87%. These percentages are subject to adjustment based on Sky's actual net cash immediately prior to closing. Q: What is the unmet medical need and commercial opportunity for RXC008 in fibrostenotic Crohn's disease?A: Lisa Anson highlighted that fibrostenotic Crohn's disease affects roughly half of the 1.7 million Crohn's disease patients, with no approved therapeutics targeting the underlying fibrotic aspects. Current standard of care uses anti-inflammatory therapies that do not prevent fibrosis progression, often leading to debilitating surgical interventions. RXC008 is designed as a first-in-class approach that can be used in combination with patients' current standard-of-care anti-inflammatory drugs, representing a significant commercial opportunity. Q: What preclinical efficacy data supports RXC008's potential?A: Lisa Anson presented robust preclinical data demonstrating that RXC008 achieved 100% reversal of established fibrosis back to baseline in the DSS model of Crohn's disease. In the adoptive T-cell transfer model, which more closely mimics human autoimmune disease, anti-TNF monotherapy did not affect ongoing fibrosis, but the combination of anti-TNF with RXC008 showed full reversal of fibrosis. The drug also demonstrated penetration to multiple layers of GI tract tissue where fibrosis occurs, without systemic exposure. Q: How does RXC008's GI-restricted mechanism work and what safety data was shown?A: Lisa Anson explained that RXC008 achieves GI restriction through three distinct mechanisms: low permeability and high efflux to keep most of the dose in the GI tract, rapid metabolism by paraoxonases in plasma for any drug entering systemic circulation, and high clearance by CYP enzymes in the liver. The Phase 1 healthy volunteer study showed no serious adverse events and zero evidence of hypotension via 24-hour telemetry monitoring. Plasma exposure was negligible with a 750-fold safety margin below the ROCK IC50, while tissue concentrations in the ileum, ascending colon, and descending colon were within the predicted efficacious range. Q: What is the timeline for RXC008's Phase 2 trial and expected data readouts?A: Lisa Anson confirmed that Phase 2 preparation is well underway with the CRO partner selected and site setup initiated. First patient enrollment is expected in Q4 2026, with top-line data expected in H2 2028 and the full data set expected in the first half of 2029. The company is collaborating with the STAR consortium and the FDA to define appropriate regulatory endpoints. Q: What is the expected cash runway for the combined company?A: Punit Dhillon stated that the concurrent financing will provide the combined company with aggregate proceeds of $125 million, providing an expected cash runway into 2029 through significant value inflection points, including the Phase 2 data readout for RXC008. Q: What is the expected timeline for closing the transaction?A: Punit Dhillon confirmed that the transaction has been unanimously approved by both boards and is expected to close in Q4 2026, subject to customary closing conditions, shareholder approvals from both Sky and Redx, sanction of the scheme of arrangement by the High Court of Justice of England and Wales, and approval of shares for listing on Nasdaq. Q: What is the status of Zolacidil (RXC007) and the DDR inhibitor program?A: Lisa Anson noted that Zolacidil has completed a successful signal-seeking Phase 2 study in idiopathic pulmonary fibrosis, with a broad preclinical dataset highlighting utility across other interstitial lung diseases, MASH, and cancer-associated fibrosis. The company is establishing the most appropriate clinical development plan, including the possibility of delivering its full potential through a partnership. The DDR program represents a novel target with a leading patent position for both selective DDR1 inhibitors and DDR1/2 inhibitors. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

CBeyond™ Expansion Study (Part C) initiated; Cohort Review Committee review scheduled for May 18, 2026, to evaluate available safety data and potential progression to Cohort 2 SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye” or the “Company”), a clinical stage biotechnology company developing next-generation molecules that modulate G-protein-coupled receptors to treat obesity, overweight, and related conditions, today reported financial results for the first quarter ended March 31, 2026, along with recent business updates and anticipated milestones. “Since our March update, execution has focused on turning CBeyond into a Phase 2b-ready development program,” said Punit Dhillon, President & CEO of Skye. “We have now initiated enrollment of Cohort 1 of the CBeyond Expansion Study, executed the compatibility and in-use study with ENHANZE to support a practical high-volume subcutaneous approach, and engaged external development advisors to help pressure-test our target product profile, dose-selection rationale and Phase 2b trial design. Our objective in 2026 remains focused on defining the dose and exposure that can support a larger Phase 2b study evaluating nimacimab as a complementary add-on approach for GLP-1-experienced patients.” Business and Clinical Highlights CBeyond™ Expansion Study (Part C) Cohort 1 is designed to evaluate nimacimab 400 mg IV (equivalent to ~700 mg SC) once weekly versus matched placebo, randomized 3:1, over a 16-week treatment period followed by 12 weeks of follow-up. The Cohort Review Committee (CRC) is scheduled to meet on May 18, 2026 to review available Cohort 1 safety data and determine whether safe-to-proceed criteria have been met to initiate enrollment in Cohort 2. Cohort 2 is designed to evaluate nimacimab 600 mg IV (equivalent to ~1000 mg SC) once weekly versus matched placebo, randomized 3:1, over the same treatment and follow-up period. Skye continues to expect topline clinical data from the CBeyond Expansion Study in Q4 2026. The study is designed to generate higher-exposure human safety and pharmacokinetic data to inform dose selection for a planned Phase 2b study. Q1 Accomplishments Skye has completed all previously announced clinical milestones for Q1: reported CBeyond interim extension data, received FDA Type C meeting minutes, launched the CBeyond Expansion Study (Part C), and completed a compatibility and in-use stability study with ENHANZE. The Company remains on track to complete the Q2 2026 catalyst set, including initiation of Cohort 2 enrollment, pending receipt of the CRC’s determination that safe-to-proceed criteria have been met, completion of enrollment across Cohorts 1 and 2, presentation or disclosure of additional preclinical bioconjugation data, and completion of feasibility work for the high-concentration nimacimab program. Clinical Data Foundation Supporting the Current Development Strategy In previously reported CBeyond data, nimacimab plus semaglutide demonstrated an approximately 3% incremental weight-loss benefit versus semaglutide alone at 26 weeks, with statistically significant improvements in waist circumference and lean-to-fat mass ratio. In the previously reported interim 52-week combination update, participants receiving nimacimab 200 mg plus semaglutide 2.4 mg achieved 22.3% mean weight loss, with no plateau observed at the time of analysis. At the tested dose, nimacimab demonstrated a favorable tolerability profile, with no nimacimab-associated neuropsychiatric safety signal observed and no additive gastrointestinal adverse-event burden when combined with semaglutide. During off-therapy follow-up, the nimacimab plus semaglutide cohort demonstrated lower weight regain than the semaglutide-alone cohort, and available body-composition data suggested maintenance of fat-mass loss and improvement in lean-to-fat mass ratio during follow-up. Skye believes these findings support development of nimacimab as complementary to, rather than competitive with, incretin therapies, particularly for GLP-1-experienced patients who plateau, require additional weight loss, are titration-limited, or need more durable metabolic control. Phase 2b Planning Skye has received written FDA Type C meeting minutes and is incorporating feedback into ongoing Phase 2b planning, including dose, duration, endpoints, inclusion/exclusion criteria and a defined indication and patient population for nimacimab as an add-on therapy to incretins. Skye has engaged Lilly Catalyze360-ExploR&D in a development consulting engagement to provide written feedback on the nimacimab target product profile, and Phase 2b trial architecture. This engagement is a development advisory engagement and does not constitute a commitment regarding any future transaction, therapeutic interest, exclusivity or corporate business development process. CMC and Drug Delivery Strategy Skye has executed the compatibility and in-use study with Halozyme’s ENHANZE® (rHuPH20) technology to support a planned site-based “mix-and-deliver” approach for high-volume subcutaneous administration of nimacimab in future clinical development. Co-formulation with ENHANZE is intended to support practical subcutaneous delivery of higher nimacimab doses. Skye continues feasibility work on a high-concentration nimacimab formulation, with the objective of reducing injection volume and supporting patient-friendly subcutaneous administration across potential dose levels. Skye continues to evaluate manufacturing process improvements, supply-chain options and cost-of-goods levers to support late-stage development and potential commercial scalability if nimacimab is approved. Upcoming Anticipated Milestones Q2 2026: Cohort Review Committee review of available Cohort 1 safety data and potential initiation of Cohort 2 enrollment. Q2 2026: Complete enrollment across CBeyond Expansion Study Cohorts 1 and 2. Q2 2026: Complete feasibility work for the high-concentration nimacimab formulation program. Q4 2026: Report topline clinical data from the CBeyond Expansion Study. Q4 2026: Finalize planned Phase 2b study design, including dose-selection rationale, protocol architecture and operational readiness plan. First Quarter 2026 Financial Results: Balance Sheet and Cash Flow Highlights Cash, cash equivalents and short-term investments totaled $17.1 million as of March 31, 2026. The Company expects its current capital to fund projected operations and key clinical milestones through the fourth quarter of 2026, including completion of its Phase 2a extension study for nimacimab and initial manufacturing to enable the anticipated Phase 2b clinical study, but excluding the anticipated clinical cost of a proposed Phase 2b clinical study and additional anticipated drug manufacturing costs to supply any such Phase 2b study. Operating Results R&D Expenses Research and development (R&D) expenses for the three months ended March 31, 2026, were $7.9 million, as compared to $7.2 million for the same period in 2025. The increase was primarily due to contract manufacturing, clinical trial costs associated with our clinical study for nimacimab, discovery research and development expenses, salaries and stock-based compensation expense, and consulting advisory and professional fees. G&A Expenses General and administrative (G&A) expenses for the three months ended March 31, 2026, were $4.7 million, as compared to $4.6 million for the same period in 2025. The increase was primarily related to increased legal fees, partially offset by decreases in investor relations, marketing and communications expenses, salaries, benefits and other direct employee related costs, and consulting, advisory and professional fees. Net Loss Net loss for the three months ended March 31, 2026, totaled $12.5 million, with non-cash stock-based compensation expense of $1.5 million, compared to $11.1 million for the same period in 2025, with non-cash stock-based compensation expense of $2.2 million. ABOUT SKYE BIOSCIENCE Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors. Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with clinical and commercial differentiation. Skye is conducting a Phase 2a clinical trial (ClinicalTrials.gov: NCT06577090) in obesity for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy®). For more information, please visit: www.skyebioscience.com. Connect with us on X and LinkedIn. FORWARD LOOKING STATEMENTS This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements relating to: nimacimab’s potential as a combination or maintenance therapy by supplement GLP-1 therapies; future clinical development of nimacimab, including the initiation and design of any future clinical trials; expectations regarding the CRC’s review of available Cohort 1 safety data to determine whether safe-to-proceed criteria have been met to initiate enrollment in Cohort 2; the outcome of Skye's evaluation of its manufacturing process improvements, supply-chain options and cost of goods levers; the expected timing for reporting data from the Phase 2a extension study; and the Company’s cash runway. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “planning,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important risks and uncertainties, including, without limitation, the initiation and design of any future clinical trials will be impacted by the Company’s capital resources, the Company’s ability to obtain additional sources of capital, program considerations and potentially other factors outside the Company’s control; the potential for additional weight loss after 26 weeks may not ultimately be observed; there is no guarantee that higher dosing of nimacimab will achieve increased efficacy, and likewise it is possible that higher dosing will produce adversely different safety and tolerability results than those observed to date; the Company’s dependence on third parties in connection with product manufacturing; research and preclinical and clinical testing; the Company’s ability to advance, obtain regulatory approval of and ultimately commercialize nimacimab; competitive products or approaches limiting the commercial value of nimacimab; the timing and results of preclinical and clinical trials; the Company’s ability to fund development activities and achieve development goals; the impact of any global pandemics, inflation, supply chain issues, government shutdowns, high interest rates, adverse regulatory changes; the Company’s ability to protect its intellectual property; risks associated with the Company’s common stock and the other important factors discussed under the caption “Risk Factors” in the Company’s filings with the Securities and Exchange Commission, including in its Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, which are accessible on the SEC’s website at www.sec.gov and the Investors section of the Company’s website. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause the Company’s views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. CONTACTS Investor Relations [email protected] (858) 410-0266 LifeSci Advisors, Mike Moyer [email protected] (617) 308-4306 Media Inquiries LifeSci Communications, Michael Fitzhugh [email protected] (628) 234-3889

CBeyond™ Expansion Study (Part C) initiated; Cohort Review Committee review scheduled for May 18, 2026, to evaluate available safety data and potential progression to Cohort 2 Engaged Lilly Catalyze360 to provide strategic guidance on nimacimab TPP and Phase 2b trial design SAN DIEGO, May 11, 2026 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye” or the “Company”), a clinical stage biotechnology company developing next-generation molecules that modulate G-protein-coupled receptors to treat obesity, overweight, and related conditions, today reported financial results for the first quarter ended March 31, 2026, along with recent business updates and anticipated milestones. “Since our March update, execution has focused on turning CBeyond into a Phase 2b-ready development program,” said Punit Dhillon, President & CEO of Skye. “We have now initiated enrollment of Cohort 1 of the CBeyond Expansion Study, executed the compatibility and in-use study with ENHANZE to support a practical high-volume subcutaneous approach, and engaged external development advisors to help pressure-test our target product profile, dose-selection rationale and Phase 2b trial design. Our objective in 2026 remains focused on defining the dose and exposure that can support a larger Phase 2b study evaluating nimacimab as a complementary add-on approach for GLP-1-experienced patients.” Business and Clinical Highlights CBeyondTM Expansion Study (Part C) Cohort 1 is designed to evaluate nimacimab 400 mg IV (equivalent to ~700 mg SC) once weekly versus matched placebo, randomized 3:1, over a 16-week treatment period followed by 12 weeks of follow-up. The Cohort Review Committee (CRC) is scheduled to meet on May 18, 2026 to review available Cohort 1 safety data and determine whether safe-to-proceed criteria have been met to initiate enrollment in Cohort 2. Cohort 2 is designed to evaluate nimacimab 600 mg IV (equivalent to ~1000 mg SC) once weekly versus matched placebo, randomized 3:1, over the same treatment and follow-up period. Skye continues to expect topline clinical data from the CBeyond Expansion Study in Q4 2026. The study is designed to generate higher-exposure human safety and pharmacokinetic data to inform dose selection for a planned Phase 2b study. Q1 Accomplishments Skye has completed all previously announced clinical milestones for Q1: reported CBeyond interim extension data, received FDA Type C meeting minutes, launched the CBeyond Expansion Study (Part C), and completed a compatibility and in-use stability study with ENHANZE. The Company remains on track to complete the Q2 2026 catalyst set, including initiation of Cohort 2 enrollment, pending receipt of the CRC’s determination that safe-to-proceed criteria have been met, completion of enrollment across Cohorts 1 and 2, presentation or disclosure of additional preclinical bioconjugation data, and completion of feasibility work for the high-concentration nimacimab program. Clinical Data Foundation Supporting the Current Development Strategy In previously reported CBeyond data, nimacimab plus semaglutide demonstrated an approximately 3% incremental weight-loss benefit versus semaglutide alone at 26 weeks, with statistically significant improvements in waist circumference and lean-to-fat mass ratio. In the previously reported interim 52-week combination update, participants receiving nimacimab 200 mg plus semaglutide 2.4 mg achieved 22.3% mean weight loss, with no plateau observed at the time of analysis. At the tested dose, nimacimab demonstrated a favorable tolerability profile, with no nimacimab-associated neuropsychiatric safety signal observed and no additive gastrointestinal adverse-event burden when combined with semaglutide. During off-therapy follow-up, the nimacimab plus semaglutide cohort demonstrated lower weight regain than the semaglutide-alone cohort, and available body-composition data suggested maintenance of fat-mass loss and improvement in lean-to-fat mass ratio during follow-up. Skye believes these findings support development of nimacimab as complementary to, rather than competitive with, incretin therapies, particularly for GLP-1-experienced patients who plateau, require additional weight loss, are titration-limited, or need more durable metabolic control. Phase 2b Planning Skye has received written FDA Type C meeting minutes and is incorporating feedback into ongoing Phase 2b planning, including dose, duration, endpoints, inclusion/exclusion criteria and a defined indication and patient population for nimacimab as an add-on therapy to incretins. Skye has engaged Lilly Catalyze360 in a development consulting engagement to provide written feedback on the nimacimab target product profile, and Phase 2b trial architecture. This engagement is a development advisory engagement and does not constitute a commitment regarding any future transaction, therapeutic interest, exclusivity or corporate business development process. CMC and Drug Delivery Strategy Skye has executed the compatibility and in-use study with Halozyme’s ENHANZE® (rHuPH20) technology to support a planned site-based “mix-and-deliver” approach for high-volume subcutaneous administration of nimacimab in future clinical development. Co-formulation with ENHANZE is intended to support practical subcutaneous delivery of higher nimacimab doses. Skye continues feasibility work on a high-concentration nimacimab formulation, with the objective of reducing injection volume and supporting patient-friendly subcutaneous administration across potential dose levels. Skye continues to evaluate manufacturing process improvements, supply-chain options and cost-of-goods levers to support late-stage development and potential commercial scalability if nimacimab is approved. Upcoming Anticipated Milestones Q2 2026: Cohort Review Committee review of available Cohort 1 safety data and potential initiation of Cohort 2 enrollment. Q2 2026: Complete enrollment across CBeyond Expansion Study Cohorts 1 and 2. Q2 2026: Complete feasibility work for the high-concentration nimacimab formulation program. Q4 2026: Report topline clinical data from the CBeyond Expansion Study. Q4 2026: Finalize planned Phase 2b study design, including dose-selection rationale, protocol architecture and operational readiness plan. First Quarter 2026 Financial Results: Balance Sheet and Cash Flow Highlights Cash, cash equivalents and short-term investments totaled $17.1 million as of March 31, 2026. The Company expects its current capital to fund projected operations and key clinical milestones through the fourth quarter of 2026, including completion of its Phase 2a extension study for nimacimab and initial manufacturing to enable the anticipated Phase 2b clinical study, but excluding the anticipated clinical cost of a proposed Phase 2b clinical study and additional anticipated drug manufacturing costs to supply any such Phase 2b study. Operating Results R&D Expenses Research and development (R&D) expenses for the three months ended March 31, 2026, were $7.9 million, as compared to $7.2 million for the same period in 2025. The increase was primarily due to contract manufacturing, clinical trial costs associated with our clinical study for nimacimab, discovery research and development expenses, salaries and stock-based compensation expense, and consulting advisory and professional fees. G&A Expenses General and administrative (G&A) expenses for the three months ended March 31, 2026, were $4.7 million, as compared to $4.6 million for the same period in 2025. The increase was primarily related to increased legal fees, partially offset by decreases in investor relations, marketing and communications expenses, salaries, benefits and other direct employee related costs, and consulting, advisory and professional fees. Net Loss Net loss for the three months ended March 31, 2026, totaled $12.5 million, with non-cash stock-based compensation expense of $1.5 million, compared to $11.1 million for the same period in 2025, with non-cash stock-based compensation expense of $2.2 million. ABOUT SKYE BIOSCIENCE Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors. Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with clinical and commercial differentiation. Skye is conducting a Phase 2a clinical trial (ClinicalTrials.gov: NCT06577090) in obesity for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy®). For more information, please visit: www.skyebioscience.com. Connect with us on X and LinkedIn. FORWARD LOOKING STATEMENTS This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements relating to: nimacimab’s potential as a combination or maintenance therapy by supplement GLP-1 therapies; future clinical development of nimacimab, including the initiation and design of any future clinical trials; expectations regarding the CRC’s review of available Cohort 1 safety data to determine whether safe-to-proceed criteria have been met to initiate enrollment in Cohort 2; the outcome of Skye's evaluation of its manufacturing process improvements, supply-chain options and cost of goods levers; the expected timing for reporting data from the Phase 2a extension study; and the Company’s cash runway. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “planning,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important risks and uncertainties, including, without limitation, the initiation and design of any future clinical trials will be impacted by the Company’s capital resources, the Company’s ability to obtain additional sources of capital, program considerations and potentially other factors outside the Company’s control; the potential for additional weight loss after 26 weeks may not ultimately be observed; there is no guarantee that higher dosing of nimacimab will achieve increased efficacy, and likewise it is possible that higher dosing will produce adversely different safety and tolerability results than those observed to date; the Company’s dependence on third parties in connection with product manufacturing; research and preclinical and clinical testing; the Company’s ability to advance, obtain regulatory approval of and ultimately commercialize nimacimab; competitive products or approaches limiting the commercial value of nimacimab; the timing and results of preclinical and clinical trials; the Company’s ability to fund development activities and achieve development goals; the impact of any global pandemics, inflation, supply chain issues, government shutdowns, high interest rates, adverse regulatory changes; the Company’s ability to protect its intellectual property; risks associated with the Company’s common stock and the other important factors discussed under the caption “Risk Factors” in the Company’s filings with the Securities and Exchange Commission, including in its Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, which are accessible on the SEC’s website at www.sec.gov and the Investors section of the Company’s website. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause the Company’s views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. CONTACTS Investor Relations [email protected] (858) 410-0266 LifeSci Advisors, Mike Moyer [email protected] (617) 308-4306 Media Inquiries LifeSci Communications, Michael Fitzhugh [email protected] (628) 234-3889

This article first appeared on GuruFocus. Release Date: March 10, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Skye Bioscience Inc (NASDAQ:SKYE) has established a potential path for namasimab alongside existing incretin therapies, showing additive weight loss and favorable tolerability. The company has delivered a series of firsts in the CB1 field, including the first human obesity program to evaluate a CB1 monoclonal antibody. Namasimab demonstrated a favorable safety profile with placebo-like tolerability and no neuropsychiatric events observed. The combination of namasimab and semaglutide achieved significant weight loss, with a 22.3% mean weight loss over 52 weeks. Skye Bioscience Inc (NASDAQ:SKYE) is advancing its R&D infrastructure, including a collaboration with Halozyme to develop a co-formulation for high-volume subcutaneous injections. The 200 mg weekly dose of namasimab was found to be underexposed for peripheral tissues, necessitating higher doses for efficacy. Despite similar serum target engagement, clinical outcomes diverged, with namasimab showing less weight loss compared to other treatments. The company is still in the process of confirming safety and PK at higher doses, which could delay further clinical trials. There is a need for a practical subcutaneous delivery path, which is still under development. The expansion study is primarily a PK and safety study, with no immediate efficacy readout expected, which may delay efficacy validation. Warning! GuruFocus has detected 1 Warning Sign with SKYE. Is SKYE fairly valued? Test your thesis with our free DCF calculator. Q: Can you talk about your plans to share data from the higher dose cohorts above 200 mg and the status of your formulation work using Halozyme technology? A: We are expanding into Part C of the CBond study to generate higher exposure data. We expect to have this data by Q4 2026. Regarding formulation, we are working with Halozyme on a mix-and-deliver approach for subcutaneous delivery, which will be ready for the Phase 2B study. The auto-injector component will be prepared for the Phase 3 trial. - Puneet Dillon, CEO; Tu, COO Q: Do you think you're going high enough with the doses in the expansion study, and is there a reason to explore even higher doses of nemasimab? A: The selected doses are consistent with our models for peripheral target engagement. We are confident these doses will provide the necessary exposure for Phase 2B selection. We are evaluating higher dosing, but the current doses should suffice. - Puneet Dillon, CEO; Chris Twitty, CSO Q: What do you see as the profile for the new program, and how do you anticipate developing it? A: The new program is long-term optionality, not a near-term value driver. The APC data supports a broader combination platform over time. Namassimab remains the core value driver, but the APC platform offers significant upside. - Puneet Dillon, CEO; Chris Twitty, CSO Q: Why are you using IV in the Part C phase of the study instead of using Enhance reconstituted at the site? A: IV provides the fastest way to generate high exposure PK and safety data. It's not the end-state product; we're building a subcutaneous path with Enhance for Phase 2B. We wouldn't have started the expansion study as quickly if we relied only on Enhance. - Puneet Dillon, CEO Q: What is the bar for success from the expanded study regarding the dose to be taken forward for monotherapy? A: The Part C study is primarily a PK and safety study. We expect the monotherapy directionality at higher exposure to validate our model. Any emerging signal will help finalize our Phase 2B dosing with confidence. - Puneet Dillon, CEO For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Initiated higher-dose CBeyond Expansion Study (Part C) to generate higher-exposure human safety and pharmacokinetic data with 400 mg and 600 mg IV cohorts; Received written FDA Type C meeting minutes; feedback is informing key Phase 2b combination design elements and the Company’s ongoing evaluation of a potential add-on development path with incretin therapy; Presented new body composition data demonstrating differentiated weight maintenance profile for patients that have discontinued combination therapy; Proof-of-concept preclinical data validates Skye's antigen-peptide conjugate platform, a single unimolecular therapeutic of nimacimab-GLP1RA that delivers additive weight-loss. SAN DIEGO, March 10, 2026 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (NASDAQ: SKYE) (“Skye” or the “Company”), a clinical stage biopharmaceutical company pioneering next-generation molecules that modulate G-protein-coupled receptors to treat obesity, overweight, and related conditions, today reported financial results for the fourth quarter and full year ended December 31, 2025, along with key accomplishments and upcoming milestones. “All of the data generated and reported in the past year along with the incremental data highlighted in todays release reinforces our strategy to develop nimacimab as a differentiated peripheral CB1 program designed to complement current incretin therapies and next-generation combination regimens. CBeyond confirmed the safety foundation and combination potential of peripheral CB1 inhibition, including a 22.3% mean weight loss at 52 weeks with nimacimab plus semaglutide and no plateau observed,” said Punit Dhillon, President & CEO of Skye. “Just as important, CBeyond has now given us three practical learnings that shape what comes next: a meaningful combination signal, clean safety with no drug-related central nervous system toxicity at the tested dose, and a clear exposure question to solve in monotherapy. Our next step is straightforward: define the peripheral exposure-response at higher doses through the Expansion Study while using the FDA Type C feedback to shape a disciplined Phase 2b evaluation with clear dose-selection logic and success criteria across monotherapy and combination development.” Clinical Highlights CBeyond Expansion Study (Part C): Higher-Exposure Evaluation Initiated the Expansion Study of CBeyond to assess preliminary safety and pharmacokinetics of nimacimab administered intravenously (IV) at doses higher than the subcutaneous (SC) regimen used in the main or extension portion of the Phase 2a trial. The CBeyond Expansion Study includes two dose cohorts of nimacimab monotherapy (400 mg IV and 600 mg IV) compared to placebo administered weekly over 15 weeks, with a 12-week follow-up period. The CBeyond Expansion Study will enroll eight (8) participants per cohort randomized 3:1 for a total of 16 participants. Skye expects to report topline data from the CBeyond Expansion Study in Q4 2026. Phase 2b (CBeyond 2): Regulatory Alignment and Protocol Finalization Completed an FDA Type C meeting and received written minutes. As Skye continues its review of the written feedback, the Company is using the minutes to sharpen its ongoing Phase 2b evaluation across key design elements (including dose, duration, endpoints and inclusion/exclusion criteria) and to assess the data package needed for potential combination development with an incretin therapy. Skye is evaluating a Phase 2b protocol that could study multiple doses of nimacimab as a monotherapy and in combination with an incretin therapy, using an adaptive design framework. Skye is continuing Phase 2b protocol development for the study. CBeyond Phase 2a Obesity Trial: 26-week Outcomes Combination signal with incretin therapy: At 26 weeks, nimacimab plus semaglutide achieved an approximately 3% incremental weight-loss benefit versus semaglutide alone, with statistically significant improvements in lean-to-fat mass ratio and waist circumference; no plateau observed through week 26. Safety and tolerability: Nimacimab demonstrated placebo-like tolerability. In combination with semaglutide, there was no increase in gastrointestinal adverse events and no difference in neuropsychiatric adverse events compared to placebo or semaglutide alone. Dose/exposure learning: Nimacimab monotherapy at 200 mg weekly did not achieve the targeted weight-loss effect; Skye believes dose and exposure are the primary variables to solve and is testing higher peripheral exposure of nimacimab. Interim 52-Week Combination Update In February 2026, Skye reported interim 52-week results in participants receiving nimacimab (200 mg dose) plus semaglutide (2.4 mg) combination, demonstrating 22.3% weight loss with no plateau observed, suggesting potential for further efficacy beyond one year and at higher nimacimab doses. Strong safety and tolerability profile maintained with no added gastrointestinal adverse events, and importantly, no drug-related neuropsychiatric adverse events. Follow-up Period 13-Week Weight Regain Update Weight regain during off-treatment follow-up was lower by over 50% — nimacimab plus semaglutide cohort regained only 17.8% of lost weight vs. 37.3% for semaglutide alone during 13-week off-therapy follow-up. Semaglutide weight regain profile similar to what has been reported in STEP-1 extension trial. Body composition data from 13-week follow-up period shows differentiated weight regain profile: Combination cohort maintained fat mass loss and gained lean mass over 13-week off-treatment follow-up period. Semaglutide cohort gained fat mass over 13-week off-treatment period. Overall, combination cohort improved lean-to-fat mass ratio during 13-week off-treatment period. Research & Development Highlights Dosing Rationale & CBeyond Trial The 200 mg weekly CBeyond dose was selected based on availability of drug and comparable Phase 1 PK modeling and IC90-normalized comparisons to monlunabant’s P2 mid-dose level — however, clinical outcomes diverged, with monlunabant achieving –6.3% weight loss versus nimacimab's –1.5%. Translational biodistribution studies across mice, NHP, and published human data revealed that peripheral tissue exposure — not serum levels — is the key determinant of efficacy. Increased dosing achieves the tissue target engagement required for robust metabolic benefit, while maintaining minimal central nervous system exposure and a strong safety margin. APC Pipeline Skye has developed an antibody-peptide conjugate (APC) program that unites nimacimab's unique CB1 inhibitory mechanism and extended half-life with the power of a GLP-1 receptor agonist in a single, unimolecular therapeutic, with a broader pipeline of novel bioconjugated molecules in development. In a preclinical proof-of-concept study, the APC dosed every three days matched the efficacy of a daily combination regimen and meaningfully exceeded either agent alone. Manufacturing Readiness and CMC Development Highlights Higher Volume Dose Delivery: Licensed ENHANZE® (recombinant human hyaluronidase) drug delivery technology from Halozyme to enable patient-friendly, high volume subcutaneous administration. Phase 2b Readiness: Manufacturing of nimacimab drug substance in anticipation of the proposed Phase 2b trial supply continued in Q4 2025, and will continue in 2026, along with manufacturing of nimacimab drug product. Optimizing Manufacturing Process for Supply & Competitive Cost of Goods (COGs): Continued evaluating manufacturing process development options aimed at increasing batch output via improvements in upstream process productivity (titer) and downstream process yield. Expanding and Strengthening the Supply Chain: Advanced diligence and discussions with commercial contract manufacturing organizations to support development and manufacturing of commercial-scale processes to enable cost-efficient supply of nimacimab for late-stage clinical trials and eventual commercial supply for the treatment of obesity, overweight, and related metabolic disorders. Drug Formulation Optimization: Continued progress in the development of a higher-concentration nimacimab formulation aimed at reducing SC injection volume in support of patient-friendly subcutaneous administration across a range of potential dose levels. Advancing Toward Monthly Dosing: Working to further evaluate and optimize nimacimab’s formulation, administration and dosing paradigm to potentially enable the transition from weekly to monthly dosing with the intent to improve the patient experience, patient and physician adoption, and overall commercial attractiveness for improved positioning of nimacimab in obesity and overweight market entry dynamics. Upcoming Anticipated Milestones Q2 2026: Present nimacimab preclinical data at scientific/medical conferences. Q2 2026: Analyst event in conjunction with the Scientific Sessions of the American Diabetes Association (ADA) in June to introduce additional clinical and preclinical data, market research insights, and other aspects of the Company’s development program. Q4 2026: CBeyond Phase 2a Expansion Study topline results to 16-weeks. Q4 2026: Finalize Phase 2b (CBeyond 2) study design. Fourth Quarter and Full Year 2025 Financial Results Balance Sheet Highlights: Cash, cash equivalents, and short-term investments totaled $25.7 million as of December 31, 2025. The Company expects its current capital to fund projected operations and key clinical milestones through the fourth quarter of 2026, including completion of its Phase 2a extension study for nimacimab and initial manufacturing to enable the anticipated Phase 2b clinical study, but excluding the anticipated clinical cost of a proposed Phase 2b clinical study and additional anticipated drug manufacturing costs to supply any such Phase 2b study. Operating Results: R&D Expenses: Research and development (R&D) expenses for the three months ended December 31, 2025, were $11.5 million, as compared to $7.8 million for the same period in 2024. The increase was primarily due to contracted manufacturing costs associated with our anticipated Phase 2b clinical trial for nimacimab in obesity and overweight, and employee related benefits. Increases were offset by a decrease in clinical costs, for the three months ended December 31, 2025 vs. 2024. R&D expenses for the year ended December 31, 2025, were $42.4 million, as compared to $18.7 million for the same period in 2024. The increase was primarily due to contracted clinical study and manufacturing costs associated with our anticipated Phase 2b clinical trial for nimacimab in obesity and overweight. The remainder of the increase resulted from increases in discovery research efforts, salaries and stock based compensation expense, and consulting fees offset by a decrease in clinical study costs. G&A Expenses: General and administrative (G&A) expenses for the three months ended December 31, 2025, were $3.4 million, as compared to $4.6 million for the same period in 2024. The decrease was primarily related to non-cash incentive stock-based compensation, payroll, benefits and other employee costs, professional services including fees for tax, audit, financial advisory services, and other general business expenses. G&A expenses for the year ended December 31, 2025, were $15.8 million, as compared to $17.7 million for the same period in 2024. The decrease was primarily related to non-cash incentive stock-based compensation, professional services including fees for tax, audit, legal services, financial advisory services, patent prosecution for nimacimab intellectual property, other general business expenses. Net Loss: Net loss for the three months ended December 31, 2025, totaled $14.4 million, with non-cash share-based compensation expense of $1.6 million, compared to $9.7 million for the same period in ended 2024, with non-cash share-based compensation expense of $2.1 million. Net loss for the year ended December 31, 2025, totaled $55.9 million, with non-cash share-based compensation expense of $7.8 million, compared to $26.6 million for the year ended 2024, with non-cash share-based compensation expense of $8.3 million. The primary reason for the significant increase in net loss is related to a $20.7 million increase in contract manufacturing costs primarily related to the Phase 2a study extension and Phase 2b drug supply. In addition, during 2024 we recognized a $4.2 million gain from the partial derecognition of contingent liabilities and a $2.0 million gain from insurance recoveries related to legal proceedings, $3.0 million in interest income and a gain of $1.4 million from the sale of real estate. Conference Call Details Skye will host a conference call to discuss its FY 2025 and Q4 2025 results at 1:30 p.m. PT/4:30 p.m. ET today, March 10th. The live streaming of the call can be accessed at the Skye Investor Relations website, along with the Company's earnings press release, financial tables, and investor presentation. Following the call, a replay and transcript will be available at the same website. About Skye Bioscience Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors. Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with clinical and commercial differentiation. Skye is conducting a Phase 2a clinical trial (ClinicalTrials.gov: NCT06577090) in obesity and overweight for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy®). For more information, please visit: www.skyebioscience.com. Connect with us on X and LinkedIn. Forward-looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements, among others, regarding: Skye’s expectations for nimacimab, including our clinical trial plans, enrollment in clinical trials, the potential applications of nimacimab; nimacimab’s potential as a combination or maintenance therapy by supplementing GLP-1 therapies, the timing of initiating clinical trials and data read-outs, including the expected timing for reporting topline data from the Phase 2a extension study; the potential for Skye to develop a leading orthogonal platform to intensify incretin outcomes and help patients achieve more durable metabolic benefit; Skye’s product development plan for nimacimab; and the Company’s cash runway. 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,” “expects,” “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 Company’s periodic filings with the Securities and Exchange Commission, including in the “Risk Factors” section of Skye’s most recent Annual Report on Form 10-K. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements. Contacts Investor Relations [email protected] (858) 410-0266 LifeSci Advisors, Mike Moyer [email protected] (617) 308-4306 Media Inquiries LifeSci Communications, Michael Fitzhugh [email protected] (628) 234-3889

22.3% total weight loss at 52 weeks with nimacimab (200 mg dose) + semaglutide (2.4 mg) combination — no plateau observed, suggesting potential for further efficacy beyond one year and at higher nimacimab doses Weight regain during treatment interruption reduced by over 50% — nimacimab + semaglutide cohort regained only 17.8% of lost weight vs. 37.3% for semaglutide alone during 13-week off-therapy follow-up, demonstrating durability advantage Strong safety and tolerability profile maintained — no serious adverse events or adverse events of special interest reported during the 52-week extension period SAN DIEGO, Feb. 02, 2026 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”) a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today announced interim 52-week data from the combination therapy arms in the extension phase of the Phase 2a CBeyond™ proof-of-concept study of nimacimab, its peripherally-restricted CB1 inhibitor antibody. CBeyond Extension Study Design and Interim Data Summary The blinded extension of the CBeyond study for combination cohorts was opened in May 2025 for participants assigned to either nimacimab plus semaglutide or placebo plus semaglutide arms. Eligible patients completed 26 weeks of treatment and were precluded from being off therapy for longer than 4 weeks. In total, 19 participants in the combination cohorts who completed week 26 were eligible for and elected to enroll in the extension study. The extension continued in a blinded manner for an additional 26 weeks, maintaining their original treatment assignment (10 nimacimab plus semaglutide; 9 placebo plus semaglutide). An additional 22 participants completed week 26 and were either ineligible for the extension or chose not to join the extension study and continued for 13 weeks on post-treatment follow-up (11 nimacimab plus semaglutide; 11 placebo plus semaglutide). Of the 10 participants in the nimacimab plus semaglutide arm who joined the extension study, the mean weight loss at 26 weeks was 14.4%. Seven (7) participants completed the additional 26 weeks of treatment and lost an additional 7.9% of weight, resulting in a mean weight loss of 22.3% after 52 weeks of treatment with no weight loss plateau observed. The combination therapy continued to demonstrate safety and was well tolerated at the tested doses. No serious adverse events or adverse events of special interest were reported during the extension period. Of the 9 participants in the placebo plus semaglutide arm that joined the extension study, mean weight loss at 26 weeks was 13.9%. Seven (7) participants completed treatment of the additional 26 weeks and lost an additional 5.8% of weight during the extension period, resulting in a mean weight loss of 19.7% after 52 weeks of treatment. In October 2025, Skye reported top-line 26-week data from CBeyond showing that the nimacimab and semaglutide combination cohort achieved clinically meaningful weight loss compared with semaglutide alone (-13.2% vs -10.25%, p=0.0372, mITT), with no plateau observed. CBeyond Interim Results – Combination Arm “Compared to other combination treatments, we believe 22.3% weight loss with no observed plateau at 52 weeks is clinically meaningful and commercially competitive, and is comparable to other combinations that have been evaluated,” said Puneet Arora, MD, FACE, Chief Medical Officer of Skye. “These results suggest that we could see even more weight loss with treatment beyond 52 weeks. We also expect even deeper weight loss with more optimized dosing of nimacimab in potential future clinical trials. Importantly, the interim data showed that the combination treatment remains safe and tolerable at the tested doses.” Weight Regain During CBeyond Off-therapy Follow-Up Period The participants treated with nimacimab + semaglutide that continued to the 13-week off-therapy follow-up regained only 17.8% of the total weight loss at 26 weeks, which represents a greater than 50% mitigation of weight rebound. In comparison, semaglutide treatment alone demonstrated a weight regain of 37.3% from the weight lost at 26 weeks, indicating a potential durable response to treatment. “Today’s interim data reinforces our vision to build a leading platform that is distinct yet complementary and able to intensify incretin outcomes and help patients achieve more durable metabolic benefit,” said Punit Dhillon, Chief Executive Officer of Skye. “We believe nimacimab’s attributes complement GLP-1 therapy through peripheral CB1 inhibition, with the potential to deepen weight loss and mitigate rebound during treatment interruptions. Our focus now is characterizing peripheral drug exposure at higher doses, dose selection, and developing plans to advance a Phase 2b program to rigorously reproduce the combination effect at scale, and optimize dose and regimen, with a goal of positioning nimacimab as a potential differentiated long-term option in obesity and related metabolic diseases.” Full topline reporting of the CBeyond Phase 2a extension data, including nimacimab monotherapy data and 13-week off-therapy follow-up, is expected in Q3 2026. About Nimacimab Nimacimab is a potential first-in-class, peripherally-restricted monoclonal antibody inhibitor of the CB1 receptor. Unlike previous CB1-targeting drugs, nimacimab is designed to avoid central nervous system penetration, potentially limiting neuropsychiatric side effects seen with small-molecule antagonists. As a non-incretin, non-peptide agent, nimacimab acts independently of the GLP-1 pathway and has also demonstrated additive or complementary effects in combination with incretin-based therapies in preclinical and clinical studies. Skye Bioscience Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors. Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with clinical and commercial differentiation. Skye is conducting a Phase 2a clinical trial (ClinicalTrials.gov: NCT06577090) in obesity for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy®). For more information, please visit: www.skyebioscience.com. Connect with us on X and LinkedIn. CONTACTS Investor Relations [email protected] (858) 410-0266 LifeSci Advisors, Mike Moyer [email protected] (617) 308-4306 Media Inquiries LifeSci Communications, Michael Fitzhugh [email protected] (415) 269-7757 FORWARD LOOKING STATEMENTS This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements relating to: the potential for higher dosing of nimacimab to achieve increased efficacy; the potential for the combination of nimacimab and semaglutide to deepen weight loss and mitigate weight rebound; the potential for future weight loss beyond 52 weeks; plans to advance nimacimab into the next stage of development to optimize dosing; future clinical development of nimacimab, including the initiation and design of any future clinical trials; the expected timing for reporting topline data from the Phase 2a extension study; the ability of nimacimab to drive weight loss without neuropsychiatric and other adverse events; the potential for nimacimab to be a first-in-class drug; the potential for Skye to develop a leading orthogonal platform to intensify incretin outcomes and help patients achieve more durable metabolic benefit; the commercially competitive nature of nimacimab combined with semaglutide; and the potential for nimacimab to be a long term option in obesity and related metabolic diseases. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “planning,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All forward-looking statements are based upon Skye’s current expectations and various assumptions. Skye believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Skye may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important risks and uncertainties, including, without limitation, the initiation and design of any future clinical trials will be impacted by Skye’s capital resources, Skye’s ability to obtain additional sources of capital needed to run an additional Phase 2 clinical trial, program considerations and potentially other factors outside the Skye’s control; the potential for additional weight loss after 52 weeks may not ultimately be observed; there is no guarantee that higher dosing of nimacimab will achieve increased efficacy, and likewise it is possible that higher dosing will produce adversely different safety and tolerability results than those observed to date; Skye’s dependence on third parties in connection with product manufacturing; research and preclinical and clinical testing; Skye’s ability to advance, obtain regulatory approval of and ultimately commercialize nimacimab, competitive products or approaches limiting the commercial value of nimacimab; the timing and results of preclinical and clinical trials; Skye’s ability to fund development activities and achieve development goals; the impact of any global pandemics, inflation, supply chain issues, government shutdowns, high interest rates, adverse regulatory changes; Skye’s ability to protect its intellectual property; risks associated with Skye’s common stock and the other important factors discussed under the caption “Risk Factors” in Skye’s filings with the Securities and Exchange Commission, including in its Annual Report on Form 10-K for the year ended December 31, 2024, which are accessible on the SEC’s website at www.sec.gov and the Investors section of Skye’s website. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Skye may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause Skye’s views to change. These forward-looking statements should not be relied upon as representing Skye’s views as of any date subsequent to the date of this press release.

ObesityWeek 2025, held in Atlanta from November 4-7, showcased unprecedented clinical data that signals a fundamental shift in the obesity treatment landscape. The most striking breakthrough at ObesityWeek 2025 came from next-generation combination therapies and innovative approaches addressing treatment limitations that have plagued earlier interventions. LAS VEGAS, Nov. 13, 2025 /PRNewswire/ -- The annual conference presented over 100 scientific sessions featuring innovations from leading pharmaceutical companies, including Novo Nordisk, Eli Lilly and Company, Viking Therapeutics, Ascletis Pharma, Skye Bioscience, Palatin Technologies, Inc., Neurogastrx, Inc., OrsoBio, Metsera, and others, revealing not only significant advances in drug efficacy but also reshaping the multibillion-dollar obesity therapeutics market. These presentations collectively demonstrate that obesity management has matured from a niche pharmaceutical focus into a major healthcare and commercial priority. Download the updated obesity market report featuring key results from ObesityWeek 2025 @ Anti-Obesity Market Let's dive deep into the promising results presented at the ObesityWeek 2025 Novo Nordisk's CagriSema: Dual and Multi-Agonist Dominance The most impactful findings centered on dual agonist therapies. CagriSema, Novo Nordisk's once-weekly injection combining cagrilintide (an amylin analogue) with semaglutide (a GLP-1 receptor agonist), demonstrated superiority over monotherapy in the REDEFINE 5 trial presented at the conference. In 331 Asian participants with overweight or obesity across 22 sites in Japan and Taiwan, CagriSema achieved an 18.4% mean weight reduction compared to 11.9% with semaglutide alone. More impressively, 95.4% of CagriSema recipients achieved ≥5% weight loss versus 78.7% on semaglutide, and 39.4% achieved ≥20% weight loss compared to only 18.6% with semaglutide. The combination therapy also reduced waist circumference by 13.5 centimeters, compared to 9.7 centimeters with semaglutide, while maintaining a comparable safety profile. This development marks a significant shift in the pharmaceutical landscape for obesity. The synergistic approach of combining mechanism classes represents an emerging standard where incremental weight loss improvements, often 5-7 percentage points, translate into substantially different patient outcomes and market positioning. Novo Nordisk's Oral Semaglutide Advances Novo Nordisk presented compelling data supporting oral semaglutide as a significant therapeutic advancement. The OASIS 4 trial, published simultaneously in The New England Journal of Medicine, demonstrated that oral semaglutide at 25 mg once daily resulted in a mean body weight reduction of 14%, compared to 2% with placebo. Notably, 30% of participants achieved a≥20% weight loss, compared to only 3% receiving the placebo, with comparable efficacy to injectable semaglutide formulations. Physical function scores improved significantly by 16 points with oral semaglutide versus 8 points with placebo, addressing a key quality-of-life metric that influences real-world adoption. The emergence of oral formulations with comparable efficacy to injectable versions fundamentally democratizes access to obesity treatment. Oral administration eliminates injection anxiety, enhances compliance, and broadens patient eligibility to those previously unwilling or unable to self-administer injectables, a substantial untapped obesity market segment. Eli Lilly's Novel Amylin Agonist Potential Eli Lilly's eloralintide, a selective amylin receptor agonist, presented impressive Phase 2 results at ObesityWeek that exceed previously established safety-efficacy trade-offs. Across 48 weeks, eloralintide demonstrated mean weight reductions ranging from 9.5% to 20.1%, depending on the dose, with all treatment arms significantly outperforming the placebo's 0.4% reduction. Remarkably, the Phase 2 results suggest improved tolerability compared to GLP-1-based agents while maintaining clinically meaningful weight loss. These findings triggered Lilly's decision to initiate Phase 3 clinical studies, anticipated to commence in December 2025. Eloralintide's distinct mechanism represents a critical therapeutic diversification. As GLP-1 supply constraints ease, this alternative pathway addresses the substantial patient population that experiences intolerance to the gastrointestinal side effects associated with incretin agonists. Viking Therapeutics' VK2735 Dual Agonist Success Viking Therapeutics presented compelling Phase 2 data from their VENTURE trial of VK2735, a dual GLP-1/GIP receptor agonist administered as a weekly subcutaneous injection. The exploratory analysis revealed that 78% of VK2735-treated patients who presented with prediabetes at baseline had successfully shifted to a normal glycemic status by week 13, dramatically outperforming the 29% normalization rate in placebo recipients (p = 0.0008). Similarly, profound results emerged for the reversal of metabolic syndrome: 68% of VK2735-treated patients who met the metabolic syndrome criteria at baseline no longer satisfied the diagnostic criteria at week 13, compared to 38% of placebo patients (p = 0.02). Previously reported data showed that VK2735 achieved statistically significant reductions in mean body weight up to 14.7% from baseline after 13 weeks, with no observed plateau. Remarkably, 88% of patients receiving VK2735 achieved ≥10% weight loss compared to only 4% in the placebo group, and the majority of treatment-emergent adverse events (92%) were mild to moderate in severity. Ascletis Pharma's Positive Obesity Pipeline Data Ascletis Pharma announced promising results from multiple studies of their obesity drug candidates at ObesityWeek 2025. The Phase Ib study of ASC30, a once-daily oral GLP-1R-biased small molecule agonist, demonstrated up to 6.5% placebo-adjusted mean body weight reduction after 28 days, with the highest dose cohort achieving a maximum weight reduction of 9.3%. The drug was well-tolerated, with only mild to moderate gastrointestinal side effects and no serious adverse events. In addition, ASC30 demonstrated ultra-long-acting potential in subcutaneous injectable forms, with half-lives supporting once-monthly treatment and once-quarterly maintenance dosing schedules. These formulations demonstrated favorable safety profiles, comparable to or superior to those of current GLP-1R agonists. Preclinical studies on a novel combination therapy of ASC31 (a dual GLP-1R and GIPR peptide agonist) with ASC47 (a thyroid hormone receptor beta-selective small molecule targeting adipose tissue) revealed significantly greater weight and body fat reduction compared to tirzepatide or ASC31 alone in diet-induced obese mice. The combination also preserved muscle and restored body composition closer to healthy levels. These data validate Ascletis' proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies, highlighting a pipeline with both oral and injectable candidates offering potential breakthroughs in chronic weight management through improved efficacy, safety, and patient convenience. Ascletis is committed to advancing clinical development and strategic partnerships globally. Skye Bioscience's Combination Approach to Weight Regain Prevention One of the most strategically important presentations came from Skye Bioscience, addressing a critical unmet clinical need: preventing weight regain after discontinuation of GLP-1 agonists. Data from their Phase 2 CBeyond trial demonstrated that nimacimab (a peripherally-restricted CB1 inhibitor antibody) plus semaglutide blunted rebound weight gain during a 12-week post-treatment period, with only 18.1% weight regain compared to 49.8% in the semaglutide-alone group. At 12 weeks post-treatment, the combination group maintained statistical significance compared to placebo (p=0.006), while the semaglutide-alone group lost statistical significance (p=0.12), following the established trajectory of rebound weight gain documented in the STEP-1 Trial Extension. During the active treatment phase, nimacimab plus semaglutide achieved additional weight loss of −13.2% versus −10.25% with semaglutide alone (p=0.0372), representing approximately a 30% improvement in weight loss magnitude. Waist circumference reductions were also superior with the combination, showing −11.26 cm versus −8.09 cm with semaglutide alone (p=0.0492). Palatin Technologies' Melanocortin Pathway Innovation Palatin Technologies presented preclinical and clinical evidence for melanocortin-4 receptor (MC4R) agonists as a complementary mechanism to incretin-based therapies. Their poster presentations highlighted PL7737, an oral MC4R small molecule agonist, which demonstrated dose-dependent weight loss in diet-induced obese mice with no observed effects on systolic blood pressure and favorable pharmacokinetics, including approximately 50% oral bioavailability and a half-life exceeding three hours in rats. A Phase II study (BMT-801) evaluated combining bremelanotide, a melanocortin-4 receptor agonist, with tirzepatide in obesity patients, revealing that adding a low-dose MC4R agonist led to greater weight loss compared to tirzepatide alone while maintaining excellent tolerability with no increased gastrointestinal side effects. Critically, sustained weight maintenance was observed when low-dose MC4R activation was used to prevent weight regain after stopping tirzepatide, a finding that parallels Skye's discoveries with the CB1 pathway. Palatin received Orphan Drug Designation for PL7737 for the treatment of leptin receptor deficiency–related obesity, with IND filing and Phase 1 trial initiation expected in the first half of 2026. Neurogastrx's Solution to GLP-1 Tolerability Challenges Addressing perhaps the most commercially significant barrier to GLP-1 therapy utilization, Neurogastrx presented proof-of-concept data from its Phase 2 study of NG101 (metopimazine mesylate), an oral peripherally restricted dopamine D2 receptor antagonist for treating GLP-1-induced gastrointestinal side effects. The study enrolled 90 participants aged 18-55 who received semaglutide plus either NG101 20 mg twice daily or placebo. Results demonstrated that NG101 significantly reduced nausea incidence by 40% (p=0.0203) and vomiting incidence by 67% (p=0.0274), while decreasing the number of discrete vomiting episodes by 56% (p=0.0238). The duration of gastrointestinal symptoms also improved substantially, with nausea and vomiting lasting more than one day occurring in 22% of NG101 recipients versus 51% of placebo recipients (p = 0.0063). Patient-reported outcomes showed a 70% reduction in nausea severity (p = 0.0138). At 12 weeks post-treatment, NG101 recipients achieved significantly reduced maximum nausea ratings of moderate-severe nausea by 31% (p=0.0225). The significance of this data becomes apparent when contextualizing that only 30% of patients initiating GLP-1 therapy for weight loss remain on treatment after one year, with gastrointestinal side effects cited as the leading cause of discontinuation. Metsera's MET-097i Phase IIb Trial Results Metsera presented positive results from two Phase IIb trials (VESPER-1 and VESPER-3) of its weight-loss drug candidate MET-097i at ObesityWeek 2025, demonstrating a strong weight loss profile comparable to that of leading drugs, such as Eli Lilly's ZEPBOUND. In the VESPER-1 trial, MET-097i achieved a placebo-subtracted mean weight loss of up to 14.1% at 28 weeks, with some individuals experiencing weight loss as high as 26.5%. The drug demonstrated competitive efficacy comparable to that of dual-agonist therapies, despite being a mono-agonist. A key highlight was MET-097i's excellent tolerability, with a low discontinuation rate of 2.9% in VESPER-1 and minimal gastrointestinal side effects, including nausea (13%) and vomiting (11%) at the highest dose in VESPER-3, along with minimal diarrhea. This tolerability profile stands out compared to current market leaders, which often cause more side effects, leading to treatment discontinuation. This progress occurs amid a bidding war for Metsera between Pfizer and Novo Nordisk, with Pfizer emerging as the winner, signaling significant interest in MET-097i's market potential. OrsoBio's Mitochondrial Protonophore Therapies for Obesity OrsoBio presented Phase 1 data for TLC-6740, while also initiating first-in-human trials for TLC-1180, a novel oral amylin receptor agonist. Preliminary seven-week efficacy data showed that low-dose TLC-1180 and semaglutide achieved similar vehicle-adjusted weight loss (11% and 14%, respectively), high-dose TLC-1180 achieved 20% weight loss, and the combination of TLC-1180 and semaglutide produced 27% weight loss with 67% reduction in fat mass without affecting lean muscle mass—a critical differentiation factor versus existing therapies. Other Notable Results Presented at ObesityWeek 2025 ObesityWeek 2025 also featured a surge of promising findings from several other pharma companies involved in obesity treatment research and innovation, including Ro, Hengrui Pharma, Kailera Therapeutics, MetaVia, Veru, Currax Pharmaceuticals, Biomea Fusion, and Aion Medicines, among others. Ro, a direct-to-patient healthcare company, presented eight research abstracts highlighting the real-world outcomes of GLP-1 treatments, such as tirzepatide and semaglutide, delivered via telehealth. Their data show substantial weight loss (up to 19.5% at 12 months) and symptom improvements in specific populations such as those with osteoarthritis or post-bariatric surgery. Ro also demonstrated how AI, including large language model triage tools, improves patient care efficiency. Additionally, they explored patient experiences such as "food noise," a measure of intrusive food thoughts that negatively affect quality of life, aiming to refine obesity care through nuanced patient insights. Hengrui Pharma and Kailera Therapeutics unveiled results from the Phase 3 GEMINI-1 trial of HRS9531, a novel dual GLP-1/GIP receptor agonist developed for Chinese adults with obesity. The trial confirmed the drug's potential for significant weight loss, surpassing that of the placebo, and improvement in cardiometabolic risk factors, including blood pressure and insulin resistance. Kailera is planning global Phase 3 trials to evaluate higher doses and longer treatment durations, advancing this treatment further. MetaVia presented Phase 1 and preclinical data for DA-1726, a dual agonist, showing promising safety and pharmacokinetics that support once-weekly dosing, as well as meaningful reductions in body weight and waist circumference in obese adults. Preclinical rodent studies suggest DA-1726 improves weight loss through increased energy expenditure and superior lipid-lowering compared to comparators. Veru Inc. presented two abstracts at ObesityWeek 2025, highlighting their next-generation drug enobosarm, a selective androgen receptor modulator (SARM) designed to enhance the selectivity of GLP-1 RA-driven weight loss for fat reduction while preserving lean mass and physical function. Their Phase 2b QUALITY clinical trial and extension demonstrated that combining enobosarm with semaglutide preserves lean body mass and function, potentially enabling greater fat loss and increased energy expenditure during active weight reduction phases. Ongoing studies are planned to assess whether enobosarm can help break weight loss plateaus in patients receiving GLP-1 RAs. Currax Pharmaceuticals highlighted new research on their oral non-GLP-1 combination therapy, CONTRAVE, focusing on craving control, behavioral adherence, and efficacy in subpopulations. Their presentations underline CONTRAVE's role in expanding obesity treatment options by addressing biological and behavioral determinants of weight management. Biomea Fusion showcased preclinical advances for BMF-650 and Icovamenib, used in combination with low-dose semaglutide, demonstrating enhanced glycemic control and weight reduction effects in rodent models. Meanwhile, Aion Medicines shared preclinical data for AM-710, an ultra-long-acting GLP-1 receptor agonist prodrug capable of dosing intervals every 3 to 6 months or longer, which showed profound and sustained weight loss and metabolic benefits in animal studies. These presentations collectively reflect significant progress in obesity treatment, emphasizing novel and long-acting therapeutics, innovative telehealth delivery models, and technology-enhanced patient management approaches, all of which are poised to redefine obesity care paradigms globally. Obesity Market Implications and Expansion ObesityWeek 2025 data crystallized a shifting competitive dynamic. The anti-obesity market is projected to grow from USD 12 billion in 2024 to approximately USD 86 billion by 2034 across the leading markets (the US, EU4, the UK, and Japan), representing a 617% increase, as per DelveInsight. These market projections reflect multiple expanding vectors: the newly diagnosed population under broadened diagnostic criteria, patients previously rationed or denied access now transitioning to treatment, and emerging therapeutic classes expanding beyond existing monotherapy limitations. While Novo Nordisk's WEGOVY and Eli Lilly's ZEPBOUND maintain dominant obesity market positioning, the proliferation of next-generation agents is establishing differentiation pathways. The emerging multi-option landscape enables precision medicine approaches where clinicians stratify patients by efficacy targets, tolerability preferences, and comorbidity profiles. This represents maturation from monotherapy-dominated markets toward personalized treatment algorithms, a transition that historically expands overall market volume by 30-50% through improved patient retention and expanded indication penetration. In summary, the conference highlighted the increasing importance of treating obesity as a chronic disease through multidisciplinary approaches that span basic science, clinical application, and public policy. Notable highlights included promising new data on GLP-1 agonists and emerging oral treatments, which showed meaningful weight loss and metabolic improvements. Notably, the event underscored challenges such as treatment adherence and access issues while highlighting innovative strategies to sustain long-term outcomes and improve quality of life for individuals living with obesity. As a global gathering of experts, ObesityWeek 2025 advanced the dialogue on transforming obesity care into personalized, patient-centered approaches. Source: Obesity Market Report Obesity Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key obesity companies, including Novo Nordisk, Eli Lilly and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, Glaceum, Shionogi, Aardvark Therapeutics, NuSirt Biopharma, Novartis, CSPC Baike (Shandong) Biopharmaceutical, Jiangsu HengRui Medicine, Carmot Therapeutics, Pfizer, Sciwind Biosciences, Empros Pharma, among others. Conference Coverage Services DelveInsight's Conference Coverage Services provide a comprehensive analysis of outcomes from major events, including ObesityWeek, AACR, ASCO, ESMO, ATS, ERS, EULAR, AAD, AAN, and SIRS, among others. Our expert team monitors key abstracts presented at conferences worldwide, delivering timely and actionable intelligence. This detailed examination provides businesses with essential insights for competitive intelligence and market trend forecasting, supporting the formulation of future strategies. Partner with DelveInsight to maximize your conference investments and stay informed on the latest industry trends, breakthroughs, and competitive dynamics. Connect with us to discover how our analysts can provide exclusive conference coverage for you @ Schedule a Meeting Now About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharmaceutical companies by providing comprehensive, end-to-end solutions to enhance their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakur [email protected] +14699457679 www.delveinsight.com Logo: https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpg View original content:https://www.prnewswire.com/news-releases/obesityweek-2025-breakthrough-results-reshaping-the-obesity-market-landscape--delveinsight-302614380.html

This article first appeared on GuruFocus. Release Date: November 10, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Skye Bioscience Inc (NASDAQ:SKYE) ended the third quarter with $35.3 million in cash and cash equivalents, expected to fund operations into 2027. The company reported promising results from its phase 2A study, showing synergistic efficacy of nemasimab plus semaglutide, achieving approximately 3% additional weight loss compared to semaglutide alone. The combination of nemasimab and semaglutide improved lean to fat mass ratio and reduced waist circumference, indicating a quality weight loss. No neuropsychiatric signals or additive gastrointestinal burdens were observed, suggesting a favorable safety profile for nemasimab. Skye Bioscience Inc (NASDAQ:SKYE) is advancing its manufacturing and CMC work, focusing on scalability and reducing costs, which aligns with their target product profile. R&D expenses increased significantly to $9.4 million from $4.9 million in the same period in 2024, primarily due to contract manufacturing and clinical trial costs. The net loss for the quarter was $12.8 million, a substantial increase from $3.9 million in the same period in 2024. The 26-week extension study enrolled only 43 patients, raising concerns about the statistical significance of the insights that can be drawn. There is uncertainty regarding the optimal dosing for nemasimab, as the current doses did not achieve the expected efficacy. The company faces challenges in ensuring compliance and retention in clinical trials, which could impact the reliability of the data. Warning! GuruFocus has detected 3 Warning Signs with RLGT. Is SKYE fairly valued? Test your thesis with our free DCF calculator. Q: Have you gained any additional insight between weight loss and exposure from the trial data? Also, regarding the 26-week extension, are 43 patients enough to draw statistically significant insights? A: We have looked at a more complete PK data set, and while the final PKPD analysis is still underway, the current data shows a credible response related to exposure. We are confident that better exposures will lead to better weight loss outcomes. Regarding the 26-week extension, although the number of patients is smaller, we believe there will be a clear separation in results, especially since the initial 26-week data showed strong differences without plateauing. Q: Do you need monotherapy approval before a potential maintenance approval? Also, why was the weight regain in the semaglutide arm faster than expected? A: For maintenance therapy with nemasimab as a monotherapy, monotherapy approval would be required. We are exploring the optimal dosing and frequency for monotherapy, including maintenance. Regarding the faster weight regain, we don't have specific demographic characteristics to explain it, but it was observed in the study. Q: What magnitude of data do you believe is clinically and commercially viable for the combo potential, and what was the quality of weight loss in terms of lean mass? A: Effective weight loss medications typically show around 20-22% weight loss. Our combination treatment has shown a 14% weight loss at 26 weeks, which is a 35% increase over semaglutide alone. The combination also improved body composition, with a higher percentage of fat loss and a better lean-to-fat mass ratio. Q: How are you weighing the pros and cons of studying a combination of namaszimab plus semaglutide for induction versus maintenance of weight loss? A: We are focused on the induction side, as the early data shows synergistic activity with no observed plateau at 26 weeks. We are evaluating the optimal dose in combination with semaglutide, and preclinical data supports the potential for deeper weight loss with higher dosing. Q: What feedback have you received from KOLs following the top-line CB on phase 2A data and at Obesity Week? A: The feedback has been positive, with interest in the combination data and the potential for a dosing holiday without significant weight regain. KOLs recognize the need for higher dosing in monotherapy and are enthusiastic about the lack of neuropsychiatric adverse events, which is a significant step forward for the class. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Topline nimacimab Phase 2a study data showed clinically meaningful weight loss in nimacimab/semaglutide combination cohort versus semaglutide alone after 26 weeks of treatment; the data demonstrated a clean neuropsychiatric safety profile and no increase in gastrointestinal adverse events. Nimacimab plus semaglutide showed additional reduction in waist circumference of -3.2 cm vs. semaglutide alone. Rebound weight gain was lower in the 12-week post-treatment follow-up period in patients treated with nimacimab plus semaglutide vs. semaglutide alone. SAN DIEGO, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye” or the “Company”), a clinical stage biotechnology company developing next-generation molecules that modulate G-protein-coupled receptors to treat obesity, overweight, and related conditions, today reported financial results for the third quarter ended September 30, 2025, along with key accomplishments and upcoming milestones. “As we obtain additional data from our CBeyond Phase 2a study, a holistic review provides us with additional confidence that nimacimab’s biology is active and has the potential to fill notable gaps in the obesity and overweight landscape in order to support a healthier weight loss journey for patients,” said Punit Dhillon, President & CEO of Skye. “With the positive combination data, we are shifting our focus to a combination development pathway while simultaneously planning to further understand nimacimab’s potential benefit in a monotherapy setting. We anticipate that forthcoming biomarker data and the readout from the 26-week extension will continue to build upon this story and provide further insights into nimacimab’s full potential as a metabolic therapy.” Clinical Highlights: CBeyond™ Phase 2a Obesity Trial Phase 2a Data Highlights: In October 2025, Skye reported 26-week topline data from its ongoing CBeyond Phase 2a study demonstrating a 29% relative increase in weight loss when nimacimab was dosed in combination with semaglutide compared to semaglutide alone. At ObesityWeek 2025, Skye shared new weight rebound data highlighting that after treatment discontinuation nimacimab plus semaglutide blunted rebound weight gain compared to semaglutide alone (18.1% versus 49.8% weight regained over 12 weeks). Moreover, at 12 weeks post-treatment, the nimacimab plus semaglutide group maintained significant weight loss compared to the placebo group. The nimacimab plus semaglutide combination also achieved an additional decrease in waist circumference of 3.2 cm (1.25 inches) compared to patients treated with semaglutide alone. In the context of the obesity treatment landscape, we believe that this data highlights nimacimab’s potential as a combination or maintenance therapy by supplementing GLP-1 therapeutics to enhance weight loss and improve body composition by targeting fat loss, without adding gastrointestinal side effects. Extension Study Fully Enrolled: In September, Skye completed the enrollment of its 26-week extension study. A total of 43 patients were enrolled, with 19 and 24 patients in the combination and monotherapy cohorts, respectively. Data from the 26-week extension is expected in Q1 2026 and will provide information on the potential full treatment duration of 52 weeks followed by a 12-week follow-up period. In the combination arms, patients will continue with blinded treatment with nimacimab or placebo and will continue receiving semaglutide (Wegovy®). Patients in the monotherapy arm will receive a higher dose of nimacimab (300 mg), which we expect will assist in refining our PK model. Third Quarter 2025 Financial Results: Balance Sheet and Cash Flow Highlights: Cash, cash equivalents and short-term investments totaled $35.3 million as of September 30, 2025. The Company expects its current capital to fund projected operations and key clinical milestones into 2027, including completion of its Phase 2a extension study of nimacimab and certain manufacturing and clinical activities, initial manufacturing runs needed to start a subsequent trial, and planning activities. In addition, our runway supports our discovery, research and development efforts along with formulation and development work in preparation for nimacimab’s later stage studies. Operating Results: R&D Expenses: Research and development (R&D) expenses for the three months ended September 30, 2025, were $9.4 million, as compared to $4.9 million for the same period in 2024. The increase was primarily due to contract manufacturing, clinical trial costs associated with our clinical study for nimacimab, discovery research and development expenses, salaries and stock based compensation expense, and consulting advisory and professional fees. G&A Expenses: General and administrative (G&A) expenses for the three months ended September 30, 2025, were $3.9 million, as compared to $4.6 million for the same period in 2024. The decrease was primarily related to decreases in consulting, advisory and professional fees, recruitment fees, salaries, and stock based compensation expense. Net Loss: Net loss for the three months ended September 30, 2025, totaled $12.8 million, with non-cash stock-based compensation expense of $1.9 million, compared to $3.9 million for the same period in 2024, with non-cash stock-based compensation expense of $1.9 million. Conference Call Details Skye will host a conference call to discuss its Q3 2025 results at 1:30 p.m. PT/4:30 p.m. ET today, November 10, 2025. The live streaming of the call can be accessed at the Skye investor relations website, along with the Company's earnings press release and financial tables. Following the call, a replay and transcript will be available at the same website. ABOUT SKYE BIOSCIENCE Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors. Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with clinical and commercial differentiation. Skye is conducting a Phase 2a clinical trial (ClinicalTrials.gov: NCT06577090) in obesity for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy®). For more information, please visit: www.skyebioscience.com. Connect with us on X and LinkedIn. FORWARD LOOKING STATEMENTS This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements relating to: nimacimab’s potential to fill notable gaps in the obesity and overweight landscape; nimacimab’s potential as a combination or maintenance therapy by supplement GLP-1 therapies; future clinical development of nimacimab, including the initiation and design of any future clinical trials; the expected timing for reporting data from the Phase 2a extension study; the Company’s cash runway. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “planning,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important risks and uncertainties, including, without limitation, the initiation and design of any future clinical trials will be impacted by the Company’s capital resources, the Company’s ability to obtain additional sources of capital, program considerations and potentially other factors outside the Company’s control; the potential for additional weight loss after 26 weeks may not ultimately be observed; there is no guarantee that higher dosing of nimacimab will achieve increased efficacy, and likewise it is possible that higher dosing will produce adversely different safety and tolerability results than those observed to date; the Company’s dependence on third parties in connection with product manufacturing; research and preclinical and clinical testing; the Company’s ability to advance, obtain regulatory approval of and ultimately commercialize nimacimab; competitive products or approaches limiting the commercial value of nimacimab; the timing and results of preclinical and clinical trials; the Company’s ability to fund development activities and achieve development goals; the impact of any global pandemics, inflation, supply chain issues, government shutdowns, high interest rates, adverse regulatory changes; the Company’s ability to protect its intellectual property; risks associated with the Company’s common stock and the other important factors discussed under the caption “Risk Factors” in the Company’s filings with the Securities and Exchange Commission, including in its Annual Report on Form 10-K for the year ended December 31, 2024, which are accessible on the SEC’s website at www.sec.gov and the Investors section of the Company’s website. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause the Company’s views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. CONTACTS Investor Relations [email protected] (858) 410-0266 LifeSci Advisors, Mike Moyer [email protected] (617) 308-4306 Media Inquiries LifeSci Communications, Michael Fitzhugh [email protected] (628) 234-3889