Skye Bioscience Reports Third Quarter 2024 Financial Results and Recent Highlights
Skye Bioscience reported Q3 2024 financial results and highlighted the launch of its Phase 2 obesity clinical trial for nimacimab, a CB1-inhibiting monoclonal antibody. The company reported cash position of $76.5 million, including restricted cash of $9.1 million. R&D expenses increased to $4.9 million from $1.3 million year-over-year, while G&A expenses rose to $4.6 million from $2.2 million. Net loss decreased to $3.9 million compared to $24.9 million in Q3 2023. The Phase 2 trial started enrolling patients in August 2024, with interim data targeted for Q2 2025 and topline data for Q4 2025.
Skye Bioscience ha riportato i risultati finanziari del terzo trimestre 2024 e ha evidenziato il lancio del suo trial clinico di Fase 2 per l'obesità con nimacimab, un anticorpo monoclonale inibitore del CB1. L'azienda ha riportato una posizione liquidità di 76,5 milioni di dollari, inclusi 9,1 milioni di dollari di liquidità vincolata. Le spese per R&S sono aumentate a 4,9 milioni di dollari rispetto a 1,3 milioni di dollari nell'anno precedente, mentre le spese generali e amministrative sono salite a 4,6 milioni di dollari rispetto a 2,2 milioni di dollari. La perdita netta è diminuita a 3,9 milioni di dollari rispetto ai 24,9 milioni di dollari nel terzo trimestre del 2023. Il trial di Fase 2 ha iniziato a reclutare pazienti ad agosto 2024, con dati intermedi previsti per il secondo trimestre del 2025 e dati finali per il quarto trimestre del 2025.
Skye Bioscience informó los resultados financieros del tercer trimestre de 2024 y destacó el lanzamiento de su ensayo clínico de Fase 2 para la obesidad utilizando nimacimab, un anticuerpo monoclonal inhibidor de CB1. La compañía reportó una posición de efectivo de $76.5 millones, incluyendo efectivo restringido de $9.1 millones. Los gastos de I+D aumentaron a $4.9 millones desde $1.3 millones en el año anterior, mientras que los gastos generales y administrativos subieron a $4.6 millones desde $2.2 millones. La pérdida neta disminuyó a $3.9 millones en comparación con $24.9 millones en el tercer trimestre de 2023. El ensayo de Fase 2 comenzó a reclutar pacientes en agosto de 2024, con datos interinos esperados para el segundo trimestre de 2025 y datos finales para el cuarto trimestre de 2025.
Skye Bioscience는 2024년 3분기 재무 결과를 발표하고 nimacimab의 비만 임상 시험 2단계 시작을 강조했습니다. nimacimab은 CB1을 억제하는 단일클론항체입니다. 회사는 7억 6500만 달러의 현금 보유액을 보고했으며, 이 중 910만 달러는 제한된 현금입니다. 연구개발 비용은 지난해 130만 달러에서 490만 달러로 증가했으며, 일반 관리 비용은 220만 달러에서 460만 달러로 증가했습니다. 순손실은 2023년 3분기 2억 4900만 달러에 비해 390만 달러로 감소했습니다. 2단계 시험은 2024년 8월에 환자 모집을 시작했으며, 중간 데이터는 2025년 2분기를 목표로 하고 있으며, 주요 데이터는 2025년 4분기를 목표로 하고 있습니다.
Skye Bioscience a publié les résultats financiers du troisième trimestre 2024 et a souligné le lancement de son essai clinique de phase 2 sur l'obésité avec le nimacimab, un anticorps monoclonal inhibiteur du CB1. L'entreprise a annoncé une position de liquidités de 76,5 millions de dollars, y compris des liquidités restreintes de 9,1 millions de dollars. Les dépenses en R&D ont augmenté à 4,9 millions de dollars contre 1,3 million de dollars l'année précédente, tandis que les dépenses générales et administratives sont passées à 4,6 millions de dollars contre 2,2 millions de dollars. La perte nette a été réduite à 3,9 millions de dollars par rapport à 24,9 millions de dollars au troisième trimestre 2023. L'essai de phase 2 a commencé le recrutement des patients en août 2024, avec des données intermédiaires prévues pour le deuxième trimestre 2025 et des données finales pour le quatrième trimestre 2025.
Skye Bioscience hat die Finanzergebnisse für das dritte Quartal 2024 veröffentlicht und den Start seiner klinischen Studie der Phase 2 zur Behandlung von Adipositas mit nimacimab hervorgehoben, einem CB1-inhibierenden monoklonalen Antikörper. Das Unternehmen berichtete von einer liquiden Mittelposition von 76,5 Millionen Dollar, einschließlich 9,1 Millionen Dollar an eingeschränkten Geldern. Die Forschungs- und Entwicklungskosten stiegen auf 4,9 Millionen Dollar im Vergleich zu 1,3 Millionen Dollar im Vorjahr, während die allgemeinen und administrativen Kosten auf 4,6 Millionen Dollar von 2,2 Millionen Dollar anstiegen. Der Nettverlust verringerte sich auf 3,9 Millionen Dollar im Vergleich zu 24,9 Millionen Dollar im dritten Quartal 2023. Die Phase-2-Studie begann im August 2024 mit der Rekrutierung von Patienten, wobei die vorläufigen Daten für das zweite Quartal 2025 und die endgültigen Daten für das vierte Quartal 2025 vorgesehen sind.
- Strong cash position of $76.5 million expected to fund operations through Q3 2027
- Significant reduction in net loss to $3.9M from $24.9M YoY
- Recovery of $9M restriction on cash expected before year-end
- Preclinical data showed up to 16% weight loss in DIO model
- R&D expenses increased 277% YoY to $4.9M
- G&A expenses increased 109% YoY to $4.6M
Insights
The Q3 results reveal a strategic shift in Skye's focus toward metabolic health, backed by a solid financial position of
The Phase 2 trial's interim data expected in Q2 2025 represents a important catalyst. The preclinical data showing up to
SAN DIEGO, Nov. 07, 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 third quarter ended September 30, 2024, and highlighted recent corporate achievements.
“The third quarter marked an important transition for Skye as a metabolic-focused company with the launch of our Phase 2 obesity clinical trial for nimacimab. We believe our truly peripherally-restricted CB1 inhibitor has the differentiated attributes necessary to realize the unique benefits of this class of drug within the overall obesity landscape,” said Punit Dhillon, CEO of Skye. “We also recently announced new preclinical data from a diet-induced obesity (DIO) model in mice. Nimacimab achieved significant dose-dependent weight loss of up to
“In the first half of the year we built on the foundation of the company in terms of people, capital, systems and preparation. Now we are focused on executing our development and clinical milestones in 2025, including interim Phase 2 data in Q2 of 2025.”
Key Corporate and Clinical Program Highlights
CBeyond Phase 2 Obesity Trial for Peripheral CB1 Inhibitor Advancing
Skye started enrolling patients in its Phase 2 study of nimacimab in August 2024. Nimacimab, a first-in-class CB1-inhibiting monoclonal antibody, is a negative allosteric modulator that acts as both an inverse agonist and antagonist. Study design:
- Randomized, doubled-blind, placebo-controlled
- Primary endpoint: designed to demonstrate an
8% difference in mean weight loss of nimacimab versus placebo at 26 weeks, with 13 weeks of follow-up - Secondary and exploratory endpoints will evaluate safety, tolerability, neuropsychiatric and cognitive outcomes, and change in body composition by DEXA, and is also assessing synergistic outcomes when nimacimab is combined with semaglutide, a GLP-1 receptor agonist
- Interim data targeted for Q2 2025:
50% enrollment of planned 120 patients after 26 weeks of treatment - Topline data targeted for Q4 2025 after full enrollment.
New Preclinical Data Provides Insight into Mechanism of CB1 Inhibition and Nimacimab
To evaluate and provide more insight into the mechanisms of CB1 inhibition and the unique elements of its differentiated CB1 inhibitor, Skye developed a novel diet-induced obesity (DIO) model. Results:
- DIO model uses a transgenic mouse expressing the human CB1 receptor (hCB1R)
- Dose-dependent weight loss with nimacimab of
4.5% ,11.4% and16.0% compared to vehicle - Significant fat mass loss with lean mass preservation
- Dose-dependent improvement in glucose tolerance
- Preliminary results provide first direct evidence supporting hypothesis that peripheral CB1 inhibition is the primary driver of weight loss whereas central CB1 inhibition contributes minimally to efficacy yet promotes neuropsychiatric adverse events. Further data will be forthcoming. A recording of this presentation, conducted as a satellite event at ObesityWeek 2024, is available here.
Corporate Highlights
- Skye appointed Dr. Puneet Arora as its Chief Medical Officer. Dr. Arora is an endocrinologist with extensive metabolic experience.
- Skye recently announced the appointment of Paul Grayson as its new Chairman of the Board.
- Subsequent to quarter end, the United States Court of Appeals for the Ninth District vacated the judgment with respect to an outstanding litigation matter. As a result, the Company will be able to recover the
$9 million restriction on its cash related to the appeal bond, which is expected to be released before year-end.
Third Quarter 2024 Financial Highlights:
Cash Position: Cash and cash equivalents totaled
R&D Expenses: Research and development (R&D) expenses for the third quarter of 2024 were
G&A Expenses: General and administrative (G&A) expenses for the third quarter of 2024 were
Net Loss: Net loss for the third quarter of 2024 totaled
Conference Call Details
Skye will host a conference call to discuss its results at 1:30 p.m. PT/4:30 p.m. ET today, November 7th. The live webcast 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 2 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 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, reporting of interim and final data from Skye’s phase 2 study of nimacimab in obesity, the timing of clinical trials for nimacimab, the therapeutic potential of nimacimab (including based on Skye’s DIO model) 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 September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 4,883,337 | $ | 1,254,653 | $ | 10,908,538 | $ | 4,227,967 | ||||||||
| Cost to acquire IPR&D asset | — | 21,215,214 | — | 21,215,214 | ||||||||||||
| General and administrative | 4,638,927 | 2,235,899 | 13,171,547 | 5,357,577 | ||||||||||||
| Change in estimate for legal contingencies | (4,553,468 | ) | — | (4,553,468 | ) | (151,842 | ) | |||||||||
| Total operating expenses | 4,968,796 | 24,705,766 | 19,526,617 | 30,648,916 | ||||||||||||
| Operating loss | (4,968,796 | ) | (24,705,766 | ) | (19,526,617 | ) | (30,648,916 | ) | ||||||||
| Other expense (income) | ||||||||||||||||
| Interest (income) expense | (90,766 | ) | 271,307 | 796,222 | 476,135 | |||||||||||
| Interest income | (907,697 | ) | (16,562 | ) | (2,296,488 | ) | (49,669 | ) | ||||||||
| (Gain) loss from asset sales | (72,837 | ) | — | (1,217,978 | ) | 307,086 | ||||||||||
| Debt conversion inducement expense | — | — | — | 1,383,285 | ||||||||||||
| Wind-down costs | — | (14,677 | ) | — | 455,504 | |||||||||||
| Other expense (income) | 801 | — | 2,200 | (3 | ) | |||||||||||
| Total other (income) expense, net | (1,070,499 | ) | 240,068 | (2,716,044 | ) | 2,572,338 | ||||||||||
| Loss before income taxes | (3,898,297 | ) | (24,945,834 | ) | (16,810,573 | ) | (33,221,254 | ) | ||||||||
| Provision for income taxes | — | — | 10,071 | 3,600 | ||||||||||||
| Net loss | $ | (3,898,297 | ) | $ | (24,945,834 | ) | $ | (16,820,644 | ) | $ | (33,224,854 | ) | ||||
| Loss per common share: | ||||||||||||||||
| Basic | $ | (0.10 | ) | $ | (3.17 | ) | $ | (0.48 | ) | $ | (6.38 | ) | ||||
| Diluted | $ | (0.10 | ) | $ | (3.17 | ) | $ | (0.48 | ) | $ | (6.38 | ) | ||||
| Weighted average shares of common stock outstanding used to compute earnings per share: | ||||||||||||||||
| Basic | 38,819,387 | 7,880,546 | 35,317,352 | 5,207,411 | ||||||||||||
| Diluted | 38,819,387 | 7,880,546 | 35,317,352 | 5,207,411 | ||||||||||||
| SKYE BIOSCIENCE, INC. AND SUBSIDIARIES | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (UNAUDITED) | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 67,412,614 | $ | 1,256,453 | ||||
| Restricted cash | 9,080,202 | 9,080,202 | ||||||
| Prepaid expenses | 664,604 | 194,259 | ||||||
| Other current assets | 2,650,809 | 1,119,929 | ||||||
| Total current assets | 79,808,229 | 11,650,843 | ||||||
| Property and equipment, net | 1,516,612 | 43,276 | ||||||
| Operating lease right-of-use asset | 184,509 | 237,983 | ||||||
| Other assets | 26,310 | 8,309 | ||||||
| Total assets | $ | 81,535,660 | $ | 11,940,411 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 780,025 | $ | 1,155,785 | ||||
| Accrued interest – related party | — | 126,027 | ||||||
| Accrued interest – legal contingency | — | 234,750 | ||||||
| Accrued payroll liabilities | 903,271 | 888,381 | ||||||
| Other current liabilities | 2,065,658 | 998,552 | ||||||
| Estimate for accrued legal contingencies and related expenses | 1,792,337 | 6,053,468 | ||||||
| Convertible note – related party, net of discount | — | 4,371,998 | ||||||
| Operating lease liability, current portion | 82,932 | 72,038 | ||||||
| Total current liabilities | 5,624,223 | 13,900,999 | ||||||
| Noncurrent liabilities | ||||||||
| Operating lease liability, net of current portion | 108,062 | 171,230 | ||||||
| Total liabilities | 5,732,285 | 14,072,229 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 30,338 | 12,349 | ||||||
| Additional paid-in-capital | 196,976,230 | 102,238,382 | ||||||
| Accumulated deficit | (121,203,193 | ) | (104,382,549 | ) | ||||
| Total stockholders’ equity | 75,803,375 | (2,131,818 | ) | |||||
| Total liabilities and stockholders’ equity | $ | 81,535,660 | $ | 11,940,411 | ||||
Contacts
Investor Relations
ir@skyebioscience.com
(858) 410-0266
LifeSci Advisors, Mike Moyer
mmoyer@lifesciadvisors.com
(617) 308-4306
Media Inquiries
LifeSci Communications, Michael Fitzhugh
mfitzhugh@lifescicomms.com
(628) 234-3889
FAQ
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