SAN DIEGO, Aug. 09, 2024 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (NASDAQ: SKYE) (“Skye” or the “Company”), a clinical-stage biopharmaceutical company focused on unlocking new therapeutic pathways for metabolic health, today reported financial results for the second quarter ended June 30, 2024, and highlighted recent corporate achievements.
“Our strategic acquisition of nimacimab in August 2023 has propelled Skye into the metabolic landscape, where there is a need to provide patients with obesity more tolerable and sustainable therapeutic alternatives to manage weight loss and address comorbid conditions,” said Punit Dhillon, CEO of Skye. “In Q2, at our event, ‘Metabolic Rewiring with CB1 Inhibition,’ we outlined our CBeyond™ Phase 2 clinical trial design and highlighted nimacimab’s differentiators, which we believe competitively position Skye. During the second quarter of 2024, we made changes to further support our metabolic focus by adding expertise to our Board of Directors and forming a clinical and scientific advisory board with key opinion leaders. We believe that our uplisting to NASDAQ and strong cash position provide us with the foundation to efficiently execute our Phase 2 obesity clinical trial and build on our strategic vision.”
Key Corporate and Clinical Program Highlights
Phase 2 Trial in Obesity Expected to Begin in Q3 2024
Nimacimab, is a first-in-class humanized monoclonal antibody that acts as a negative allosteric modulator to inhibit CB1 signaling in the periphery.
Completion of Glaucoma Study
Corporate Highlights
Second Quarter 2024 Financial Highlights:
Cash Position: Cash and cash equivalents totaled $74.1 million, excluding restricted cash of $9.1 million on June 30, 2024. The Company expects its current cash and cash equivalents to fund projected operations through at least the first half of 2027.
R&D Expenses: Research and development (R&D) expenses for the second quarter of 2024 were $4.1 million, as compared to $1.8 million for the same period in 2023. The increase was primarily due to costs associated with the completion of our Phase 2a clinical trial for glaucoma, which has since been discontinued, and the costs from the preparation of the launch of our Phase 2 clinical trial for the treatment of obesity.
G&A Expenses: General and administrative (G&A) expenses for the second quarter of 2024 were $4.3 million, as compared to $1.2 million for the same period in 2023. The increase was primarily due to increases in non-cash incentive stock-based compensation, professional services and fees associated with the Company’s January and March 2024 PIPE financings, uplisting to NASDAQ and expansion to support and advance its operations as a publicly-traded company.
Net Loss: Net loss for the second quarter of 2024 totaled $7.9 million, with non-cash share-based compensation expense of $1.8 million and non-cash interest expense of $0.3 million, compared to $3.1 million for the second quarter of 2023 with non-cash share-based compensation expense of $0.1 million.
1 Shazia Jehan et al, “Obstructive Sleep Apnea and Obesity: Implications for Public Health,” Sleep Med Disord. 2017; 1(4): 00019. Published online 2017 Dec 12.
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 plans to start a Phase 2 clinical trial in obesity in Q3 2024 for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1, comparing monotherapy and combination arms of nimacimab and a GLP-1R agonist (Wegovy®). For more information, please visit: https://www.skyebioscience.com. Connect with us on Twitter 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 regarding our product development for nimacimab, business strategy, the timing of clinical trials for nimacimab, the therapeutic potential of nimacimab and the expected timing through which our current cash and cash equivalents will fund our operating plans. 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 and Quarterly Report on Form 10-Q. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements.
SKYE BIOSCIENCE, INC. AND SUBSIDIARIES | |||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
(UNAUDITED) | |||||||||||||||
For the Three Months Ended June 30, | For the Six Months Ended June 30, | ||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
Operating expenses | |||||||||||||||
Research and development | $ | 4,078,751 | $ | 1,788,434 | $ | 6,025,201 | $ | 2,973,314 | |||||||
General and administrative | 4,326,820 | 1,206,405 | 8,532,620 | 3,121,683 | |||||||||||
Estimated legal contingency | — | (151,842 | ) | — | (151,842 | ) | |||||||||
Total operating expenses | 8,405,571 | 2,842,997 | 14,557,821 | 5,943,155 | |||||||||||
Operating loss | (8,405,571 | ) | (2,842,997 | ) | (14,557,821 | ) | (5,943,155 | ) | |||||||
Other (income) expense | |||||||||||||||
Interest expense | 450,052 | 186,429 | 886,988 | 204,828 | |||||||||||
Interest income | (961,237 | ) | (8,598 | ) | (1,388,791 | ) | (33,112 | ) | |||||||
(Gain) loss from asset sales | — | — | (1,145,141 | ) | 307,086 | ||||||||||
Debt conversion inducement expense | — | — | — | 1,383,285 | |||||||||||
Wind-down costs | — | 87,072 | — | 470,181 | |||||||||||
Other expense (income) | 359 | — | 1,399 | (3 | ) | ||||||||||
Total other (income) expense, net | (510,826 | ) | 264,903 | (1,645,545 | ) | 2,332,265 | |||||||||
Loss before income taxes | (7,894,745 | ) | (3,107,900 | ) | (12,912,276 | ) | (8,275,420 | ) | |||||||
Provision for income taxes | 8,071 | 3,600 | 10,071 | 3,600 | |||||||||||
Net loss | $ | (7,902,816 | ) | $ | (3,111,500 | ) | $ | (12,922,347 | ) | $ | (8,279,020 | ) | |||
Loss per common share: | |||||||||||||||
Basic | $ | (0.20 | ) | $ | (0.80 | ) | $ | (0.39 | ) | $ | (2.16 | ) | |||
Diluted | $ | (0.20 | ) | $ | (0.80 | ) | $ | (0.39 | ) | $ | (2.16 | ) | |||
Weighted average shares of common stock outstanding used to compute earnings per share: | |||||||||||||||
Basic | 38,669,330 | 3,886,198 | 33,334,616 | 3,827,216 | |||||||||||
Diluted | 38,669,330 | 3,886,198 | 33,334,616 | 3,827,216 |
SKYE BIOSCIENCE, INC. AND SUBSIDIARIES | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
(UNAUDITED) | |||||||
June 30, 2024 | December 31, 2023 | ||||||
ASSETS | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 74,120,854 | $ | 1,256,453 | |||
Restricted cash | 9,080,202 | 9,080,202 | |||||
Prepaid expenses | 1,096,039 | 194,259 | |||||
Other current assets | 2,707,368 | 1,119,929 | |||||
Total current assets | 87,004,463 | 11,650,843 | |||||
Property and equipment, net | 45,772 | 43,276 | |||||
Operating lease right-of-use asset | 202,987 | 237,983 | |||||
Other assets | 8,309 | 8,309 | |||||
Total assets | $ | 87,261,531 | $ | 11,940,411 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | |||||||
Current liabilities | |||||||
Accounts payable | $ | 1,079,493 | $ | 1,155,785 | |||
Accrued interest - related party | 124,658 | 126,027 | |||||
Accrued payroll liabilities | 556,573 | 888,381 | |||||
Accrued interest - legal contingency | 384,896 | 234,750 | |||||
Other current liabilities | 1,184,795 | 998,552 | |||||
Estimate for legal contingency | 6,053,468 | 6,053,468 | |||||
Convertible note - related party, net of discount | 4,859,525 | 4,371,998 | |||||
Operating lease liability, current portion | 79,165 | 72,038 | |||||
Total current liabilities | 14,322,573 | 13,900,999 | |||||
Non-current liabilities | |||||||
Operating lease liability, net of current portion | 129,907 | 171,230 | |||||
Total liabilities | 14,452,480 | 14,072,229 | |||||
Commitments and contingencies (Note 9) | |||||||
Stockholders’ equity (deficit) | |||||||
Preferred stock, $0.001 par value; 200,000 shares authorized at June 30, 2024 and December 31, 2023; no shares issued and outstanding at June 30, 2024 and December 31, 2023 | — | — | |||||
Common stock, $0.001 par value; 100,000,000 shares authorized at June 30, 2024 and December 31, 2023; 28,067,907 and 12,349,243 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | 28,068 | 12,349 | |||||
Additional paid-in-capital | 190,085,879 | 102,238,382 | |||||
Accumulated deficit | (117,304,896 | ) | (104,382,549 | ) | |||
Total stockholders’ equity (deficit) | 72,809,051 | (2,131,818 | ) | ||||
Total liabilities and stockholders’ equity (deficit) | $ | 87,261,531 | $ | 11,940,411 |
Contacts
Investor Relations
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(858) 410-0266
LifeSci Advisors, Mike Moyer
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(617) 308-4306
Media Inquiries
LifeSci Communications, Michael Fitzhugh
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(628) 234-3889
Last Trade: | US$4.17 |
Daily Change: | -0.11 -2.57 |
Daily Volume: | 101,177 |
Market Cap: | US$126.520M |
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