SAN DIEGO, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biopharmaceutical company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, will present a corporate overview at the 43rd Annual J.P. Morgan Healthcare conference on Thursday, January 16, 2025, at 10:30 AM - 11:10 AM. A live and archived webcast will be accessible on Skye’s website. About Skye Bioscience Skye is focused on unlocking new therapeutic pathw ...

Financial Data and Key Metrics Changes - Research and development expenses for Q3 2024 were $4.9 million, up from $1.3 million in Q3 2023, primarily due to clinical and manufacturing costs associated with the Phase 2 trial for nimacimab [27] - General and administrative expenses increased to $4.6 million in Q3 2024 from $2.2 million in Q3 2023, driven by non-cash stock-based compensation and professional services [28] - The net loss for Q3 2024 was $3.9 million, significantly reduced from a net loss of $24.9 million in Q3 2023, largely due to the absence of a major acquisition expense [29] - Cash and cash equivalents as of September 30, 2024, were $76.5 million, with an expected increase in quarterly burn rate to approximately $9 million in 2025 [30][31] Business Line Data and Key Metrics Changes - The company is focused on advancing the Phase 2 obesity clinical trial named CBeyond, which is currently enrolling patients and tracking towards interim data announcement by Q2 2025 [19][20] - The CBeyond trial aims to demonstrate an 8% difference in mean weight loss using nimacimab versus placebo at 26 weeks, with secondary endpoints evaluating safety and tolerability [20][21] Market Data and Key Metrics Changes - The company is positioning nimacimab as a strong candidate in the anti-obesity medication landscape, aiming to establish itself as a leader in non-incretin metabolic therapies [22][39] - The competitive landscape includes incretin mimetics, with the company emphasizing the unique peripheral mechanism of nimacimab as a complementary alternative [58] Company Strategy and Development Direction - The company aims to create a comprehensive clinical pipeline in metabolic health, focusing on optimizing nimacimab's clinical profile and exploring additional GPCR targets [24][25] - The strategic roadmap over the next three years includes delivering key clinical and preclinical data while preparing for late-stage clinical development of nimacimab [41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of nimacimab to drive significant weight loss without neuropsychiatric adverse events, differentiating it from previous small molecule CB1 inhibitors [39][40] - The company is focused on regulatory approval for nimacimab as a monotherapy, while exploring combination therapies with GLP-1 drugs for future commercial opportunities [90] Other Important Information - The company has added key personnel to its team, including a Chief Medical Officer with extensive metabolic experience, to strengthen its operational capabilities [36] - The company is actively engaging with key opinion leaders (KOLs) to enhance understanding and support for its clinical data and mechanisms of action [52][56] Q&A Session Summary Question: Can you provide an update on CBeyond enrollment and expected data? - Management confirmed that enrollment is progressing well, with expectations to reach 50% enrollment before year-end, focusing on monotherapy weight loss as the primary endpoint [45][46] Question: What feedback was received from KOLs regarding preclinical data? - KOL feedback highlighted the importance of peripheral CB1 inhibition for weight loss, with positive responses to the preclinical efficacy of nimacimab [52][56] Question: How does the company view the commercial path for GLP-1 combinations? - The company sees potential for nimacimab as a complementary treatment alongside GLP-1 drugs, but emphasizes the primary focus on regulatory approval as a monotherapy [90] Question: What are the mechanisms behind neuropsychiatric adverse events in central CB1 targeting? - Management explained that central CB1 inhibition can lead to adverse events by blocking pathways that regulate mood and stress responses, which is not a concern with peripheral targeting [84][86] Question: Will further preclinical work be conducted comparing nimacimab with other CB1 modulators? - The company plans to continue preclinical studies to better understand nimacimab's mechanism and explore combinations with other anti-obesity medications [64][65]

Research and Development Expenses - For the three months ended September 30, 2024, the company incurred $4,883,337 in research and development expenses, a significant increase from $1,254,653 for the same period in 2023, primarily related to the Phase 2 clinical trial of nimacimab for obesity [77]. - Research and development expenses for the three months ended September 30, 2024, increased by $3,628,684 (289%) compared to the same period in 2023, totaling $4,883,337 [82]. - Research and development expenses for the nine months ended September 30, 2024, increased by $6,680,571 (158%) compared to the same period in 2023, totaling $10,908,538 [87]. - The increase in research and development expenses was primarily due to a $2,735,109 increase in contracted clinical and manufacturing costs for the Phase 2 clinical trial of nimacimab for obesity [82]. - The company anticipates ongoing research and development expenses will include costs for employee-related expenses, payments to third-party organizations, and manufacturing [78]. Clinical Trials - The Phase 2 clinical trial, CBeyond, for nimacimab includes 120 patients and aims to achieve 50% enrollment by the end of 2024, with interim data expected in Q2 2025 and topline data in Q4 2025 [73]. - The primary endpoint of the CBeyond trial is to evaluate weight loss using nimacimab compared to placebo, with secondary endpoints including safety, tolerability, and changes in metabolic biomarkers [73]. - The company completed a Phase 2a trial of SBI-100 Ophthalmic Emulsion in June 2024, which did not achieve statistically significant improvement, leading to the elimination of the ocular program [75]. Financial Performance - The company has not generated any revenue to date and does not expect to until regulatory approval and commercialization of nimacimab or future drug candidates [76]. - General and administrative expenses for the three months ended September 30, 2024, increased by $2,403,028 (107%) compared to the same period in 2023, totaling $4,638,927 [84]. - General and administrative expenses for the nine months ended September 30, 2024, increased by $7,813,970 (146%) compared to the same period in 2023, totaling $13,171,547 [90]. - Operating losses for the nine months ended September 30, 2024, were $19,526,617, compared to $30,648,916 for the same period in 2023 [94]. - Cash used in operating activities was $17,064,377 for the nine months ended September 30, 2024, reflecting a net loss of $16,820,644 [97]. Funding and Capital - The company raised a total of $83,556,563 from private placement equity transactions in January and March 2024, which will fund the clinical trial for obesity and expand the metabolic program [75]. - A Convertible Note with a principal value of $5,000,000 was converted into 968,973 shares of common stock in August 2024 [75]. - The company raised $83,556,563 in net proceeds from January and March PIPE Financings to fund its Phase 2 clinical trial for obesity [94]. - The company has not sold any shares under the ATM Agreement as of the date of the report, which allows for the sale of up to $100,000,000 of common stock [94]. Legal and Regulatory Matters - The Ninth Circuit Court of Appeals vacated the judgment in the Cunning Lawsuit, allowing the company to potentially extend its cash runway by the end of 2024 [75]. - The company expects to recover $9,080,202 in cash by exonerating the bond related to the Cunning Lawsuit, which will extend its cash runway [95]. - The change in estimate for legal contingencies for the three months ended September 30, 2024, was $(4,553,468), representing a 100% change [85]. - The change in estimate for legal contingencies for the nine months ended September 30, 2024, was $(4,553,468), a 2899% increase compared to $(151,842) in 2023 [92]. Other Financial Metrics - Interest income for the three months ended September 30, 2024, increased by $891,135 (5381%) compared to the same period in 2023 [86]. - Total other (income) expense for the three months ended September 30, 2024, was $(1,070,499), a decrease of $1,310,567 (546%) compared to the same period in 2023 [86]. - For the nine months ended September 30, 2024, the company reported a net other income of $2,716,044, primarily due to a gain on the sale of the AVI building and collections from the sale of VDL totaling $1,217,978 [93]. - Total other (income) expense for the nine months ended September 30, 2024, was $(2,716,044), a significant change from $2,572,338 in 2023, reflecting a 206% change [93]. - The company had working capital of $74,184,006 and an accumulated deficit of $121,203,193 as of September 30, 2024, with unrestricted cash and cash equivalents amounting to $67,412,614 [94].

Financial Performance - Skye Bioscience reported a net loss of $3.9 million for Q3 2024, a significant decrease from a net loss of $24.9 million in Q3 2023[9]. - General and administrative expenses rose to $4.6 million in Q3 2024, up from $2.2 million in Q3 2023, mainly due to non-cash stock-based compensation and professional services[9]. - The accumulated deficit increased to $(121,203,193) from $(104,382,549), indicating a rise in losses of about 16%[14]. Research and Development - Research and development expenses increased to $4.9 million in Q3 2024, compared to $1.3 million in the same period last year, primarily due to costs associated with the Phase 2 clinical trial for nimacimab[9]. - The Phase 2 obesity trial for nimacimab began patient enrollment in August 2024, targeting an 8% difference in mean weight loss compared to placebo at 26 weeks[3]. - Interim data from the Phase 2 trial is expected in Q2 2025, with topline data anticipated in Q4 2025 after full enrollment of 120 patients[3]. - New preclinical data showed dose-dependent weight loss of up to 16% in a diet-induced obesity model using nimacimab[4]. Cash and Assets - Cash and cash equivalents totaled $76.5 million as of September 30, 2024, with $9.1 million classified as restricted cash[8]. - Total current assets increased significantly to $79,808,229 as of September 30, 2024, compared to $11,650,843 on December 31, 2023, representing a growth of approximately 584%[14]. - Cash and cash equivalents rose to $67,412,614 from $1,256,453, marking an increase of over 5300%[14]. - Total assets reached $81,535,660, a substantial increase from $11,940,411, representing a growth of approximately 583%[14]. Liabilities and Equity - Total liabilities decreased to $5,732,285 from $14,072,229, a reduction of approximately 59%[14]. - Current liabilities decreased to $5,624,223 from $13,900,999, a decline of about 60%[14]. - Stockholders' equity improved to $75,803,375 from a deficit of $(2,131,818), indicating a turnaround of over $77 million[14]. - Additional paid-in capital rose to $196,976,230 from $102,238,382, reflecting an increase of approximately 93%[14]. Leadership and Legal Matters - Skye appointed Dr. Puneet Arora as Chief Medical Officer, enhancing its leadership in metabolic health[6]. - The U.S. Court of Appeals vacated a judgment related to litigation, allowing the company to recover $9 million in cash previously restricted[7].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 000-55136 Skye Bioscience, Inc. _____________________________________________________________ (Exact name of regis ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 000-55136 Skye Bioscience, Inc. _____________________________________________________________ (Exact name of regi ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 000-55136 Skye Bioscience, Inc. (Exact name of registrant as specified in its charter) | --- | --- | |---------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 000-55136 Skye Bioscience, Inc. _____________________________________________________________ (Exact name of ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 000-55136 Skye Bioscience, Inc. _____________________________________________________________ (Exact name of regis ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 000-55136 Skye Bioscience, Inc. _____________________________________________________________ (Exact name of regi ...