Skye Bioscience Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
-- Enrollment completed in Phase 2a CBeyond$(TM)$ trial of CB1 inhibitor, nimacimab, in obesity and overweight -- Faster-than-expected enrollment enables full top-line Phase 2a data in late Q3/early Q4 2025, ahead of schedule; interim analysis removed -- Phase 2a dosing extended to 52 weeks to enhance long-term safety, tolerability, and efficacy data -- Cash runway projected through at least Q1 2027
SAN DIEGO, March 20, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. $(SKYE)$ ("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, 2024, along with key accomplishments and upcoming milestones.
"Skye's prime accomplishment in 2024 was the initiation and rapid advancement of its comprehensive Phase 2a clinical study of nimacimab, a novel and differentiated CB1 inhibitor," said Punit Dhillon, President & CEO of Skye. "Maturation of the obesity therapeutics landscape, including expanding clinical evidence, M&A, and licensing, highlights the strategic importance of alternative mechanisms of action with attributes differentiated from incretins. We believe nimacimab's product profile is well-positioned to potentially fulfill critical unmet needs in this rapidly evolving therapeutic area.
"Our team showed discipline in capital allocation and focus in executing the Company's priorities. We surpassed our enrollment target ahead of schedule and have to-date executed the Phase 2a clinical plan on target and within our budget. We disclosed preclinical data in November 2024 which achieved significant dose-dependent weight loss, significant fat mass loss with lean mass preservation, and dose-dependent improvement in glucose tolerance. These outcomes are indicative of the potentially compelling attributes of Skye's highly peripherally-restricted CB1 inhibitor. In 2025 and beyond we will continue to apply this discipline and focus. We are enthusiastic about our updated clinical development plan, which will dramatically speed up our path to important 52-week treatment data from this extension study. Robust data in 2025 and 2026 will be valuable to various stakeholders and inform our regulatory engagement for future studies and decision-making."
Clinical Highlights: CBeyond(TM) Phase 2 Obesity Trial
-- CBeyond(TM) trial completed enrollment of 136 patients: Study enrollment
exceeded the initial target of 120, with data blinded through the
completion of the 26-week treatment and 13-week follow-up period.
-- Data Safety Monitoring Board reviews completed: Two independent data
safety monitoring board reviews have been successfully completed.
-- 16 US Clinical Sites: Welcomed a leading academic center of excellence in
obesity as a clinical trial site during Q1 2025.
-- Accelerated timeline for 26-week data to late Q3/early Q4 2025: Due to
faster-than-anticipated enrollment the interim analysis has been removed
and top line data is expected to be reported earlier than previously
reported.
-- Expansion of the CBeyond(TM) trial: To obtain 52 weeks of treatment data,
the trial extension increases the originally planned 26 weeks of
treatment to provide a longer-term assessment of safety, tolerability and
efficacy. The protocol extension will provide for continued assessment of
both the nimacimab monotherapy (primary endpoint) and the nimacimab/GLP-1
combination cohort (exploratory endpoint).
Research & Development Highlights
-- Vital role and sufficiency of peripherally-targeted CB1 inhibition:
Initial data from our diet-induced obesity model in mice released in
November 2024 confirms that central CB1 inhibition is not required, and
supports our hypothesis that nimacimab's peripherally-targeted CB1
inhibition drives significant weight loss and improved metabolic
parameters, consistent with the compound's differentiated mechanism of
action. An ongoing effort to characterize various attributes of
nimacimab's capabilities as the most peripherally restricted CB1
inhibitor is expected to result in further preclinical data outcomes.
-- Broadening metabolic pathway understanding: Current studies are
leveraging translational models to demonstrate nimacimab's role in
modulating hormones, inflammatory mediators, lipid metabolism, and
glycemic control. We believe that additional data expected in the coming
quarters may further clarify nimacimab's potential across a range of
metabolic disorders.
-- Next-generation GPCR programs: The Company is advancing development of
next-generation GPCR-targeting molecules designed to address diverse
metabolic disorders.
Manufacturing Highlights
-- Strengthening manufacturing: Advancing activities in collaboration with
contract manufacturing organizations to prepare for future clinical
demand for nimacimab and further optimize its potential for the treatment
of obesity, overweight, and related metabolic disorders.
-- Optimizing scale-up processes: Evaluating modifications to upstream and
downstream manufacturing processes to improve product yield and establish
a commercial manufacturing process that is reliable and repeatable for
large-scale commercial production.
-- Advancing toward monthly dosing: We are working to optimize nimacimab's
formulation and delivery to transition from weekly to monthly dosing to
potentially improve patient experience, adherence, and commercial
viability.
Corporate Highlights
-- Chief Development Officer promotion: Skye recently promoted Tu Diep, to
COO, recognizing his leadership throughout the Company. In this role, Mr.
Diep is overseeing our development operations, CMC, corporate development
and broader strategic execution.
-- Strengthened the internal and external chemistry, manufacturing, and
controls team: During 2024, Skye added to its team with seasoned
individuals who bring significant experience in quality control and
scale-up to nimacimab's manufacturing processes.
-- Resolved litigation matter: Skye settled its insurance litigation case
and received $2 million in cash proceeds from its former D&O carrier in
the fourth quarter of 2024.
Upcoming Milestones
-- Q2 2025: Nimacimab preclinical data being presented at scientific/medical
conferences.
-- Q2 2025: Analyst event in conjunction with the Scientific Sessions of the
American Diabetes Association $(ADA.AU)$ in June to introduce additional
preclinical data, market research insights, and other aspects of the
Company's development program.
-- Late Q3/early Q4 2025: Phase 2a CBeyond top-line data; full patient
enrollment over 26 weeks of treatment and follow-up.
Fourth Quarter and Full Year 2024 Financial Results:
Balance Sheet Highlights:
-- In January and March 2024, Skye closed two private investment in public
equity transactions which collectively resulted in approximately $83.6
million in net proceeds.
-- Cash and cash equivalents totaled $68.4 million on December 31, 2024. The
Company expects its current capital to fund projected operations and key
clinical milestones through at least Q1 2027, including completion of its
Phase 2a study for nimacimab and Phase 2b manufacturing but excluding the
Phase 2b clinical study or manufacturing activities necessary to supply a
Phase 3 clinical study.
-- Elimination of all related party balances, including the conversion of $5
million of debt to equity.
Operating Results:
-- R&D Expenses:Research and development (R&D) expenses for the three months
ended December 31, 2024, were $7.8 million, as compared to $1.6 million
for the same period in 2023. The increase was primarily due to contracted
clinical and manufacturing costs associated with our Phase 2 clinical
trial for nimacimab in obesity and employee related benefits.R&D expenses
for the year ended December 31, 2024, were $18.7 million, as compared to
$5.8 million for the same period in 2023. The increase was primarily due
to contracted clinical and manufacturing costs associated with our Phase
2 clinical trial for nimacimab in obesity. The remainder of the increase
resulted from increases in discovery research efforts, consulting fees,
employee benefits driven by increases in headcount, and general expenses.
-- G&A Expenses:General and administrative (G&A) expenses for the three
months ended December 31, 2024, were $4.6 million, as compared to $2.5
million for the same period in 2023. The increase was primarily related
to non-cash incentive stock-based compensation, payroll, benefits and
other employee costs, professional services including fees for tax, audit,
legal services, financial advisory services, and other general business
expenses.G&A expenses for the year ended December 31, 2024, were $17.7
million, as compared to $7.9 million for the same period in 2023. The
increase 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, 2024, totaled
$9.7 million, with non-cash share-based compensation expense of $2.1
million, compared to $4.4 million for the year ended 2023, with non-cash
share-based compensation expense of $0.6 million.Net loss for the year
ended December 31, 2024, totaled $26.6 million, with non-cash share-based
compensation expense of $8.3 million, compared to $37.6 million for the
year ended 2023, with non-cash share-based compensation expense of $1.0
million. The primary reason for the significant decrease related to the
acquisition of the nimacimab in-process research and development asset
for $21.2 million during the year ended December 31, 2023, all of which
was expensed upon acquisition. 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 $1.4
million from the sale of real estate.
Conference Call Details
Skye will host a conference call to discuss its FY 2024 and Q4 2024 results at 1:30 p.m. PT/4:30 p.m. ET today, March 20th. The live streaming of the call can be accessed at the Skye Investor Relations website, along with the Company's earnings press release, financial tables, and investor presentation. Following the call, a replay and transcript will be available at the same website.
About Skye Bioscience
Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors. Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with clinical and commercial differentiation. Skye is conducting a Phase 2 clinical trial (ClinicalTrials.gov: NCT06577090) in obesity for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy$(R)$). 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: Skye's future plans and prospects, Skye's product development plan for nimacimab; the planned timing for reporting of data from Skye's phase 2a study of nimacimab in obesity; the therapeutic potential of nimacimab, including based on Skye's diet induced obesity mouse model; the potential applications of nimacimab; expectations around nimacimab's differentiated mechanism of action; expectations regarding the superior safety and tolerability profile of nimacimab relative to other small molecule CB1 inhibitors 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. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements.
SKYE BIOSCIENCE, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended
December 31
(Unaudited) Year Ended December 31
2024 2023 2024 2023
------------- ------------ ------------- ---------------
Operating
expenses
Research and
development $ 7,793,156 $ 1,591,494 $ 18,701,694 $ 5,819,461
Cost to acquire
IPR&D asset -- -- -- 21,215,214
General and
administrative 4,622,945 2,494,763 17,725,741 7,852,340
Change in
estimate for
legal
contingency -- -- (4,234,717) (151,842)
Income from
insurance
recovery (1,750,000) -- (2,000,000) --
----------- ---------- ----------- -----------
Total
operating
expenses 10,666,101 4,086,257 30,192,718 34,735,173
----------- ---------- ----------- -----------
Operating loss (10,666,101) (4,086,257) (30,192,718) (34,735,173)
----------- ---------- ----------- -----------
Other (income)
expense
Interest
expense (46,914) 430,135 749,308 906,270
Interest income (732,274) (50,305) (3,028,762) (99,974)
Wind-down costs -- (46,157) -- 409,347
(Gain) loss
from asset
sale (140,434) -- (1,358,412) 307,086
Debt conversion
inducement
expense -- -- -- 1,383,285
Other expense
(income) -- -- 2,200 (3)
----------- ---------- ----------- -----------
Total other
(income)
expense,
net (919,622) 333,673 (3,635,666) 2,906,011
Loss before
income taxes (9,746,479) (4,419,930) (26,557,052) (37,641,184)
Provision for
income taxes -- -- 10,071 3,600
----------- ---------- ----------- -----------
Net loss $ (9,746,479) $(4,419,930) $(26,567,123) $(37,644,784)
=========== ========== =========== ===========
Loss per common
share
Basic $ (0.24) $ (0.36) $ (0.73) $ (5.37)
----------- ---------- ----------- -----------
Diluted $ (0.24) $ (0.36) $ (0.73) $ (5.37)
----------- ---------- ----------- -----------
Weighted average
shares of common
stock outstanding
used to compute
loss per share:
Basic 39,968,601 12,343,269 36,486,519 7,006,038
----------- ---------- ----------- -----------
Diluted 39,968,601 12,343,269 36,486,519 7,006,038
----------- ---------- ----------- -----------
SKYE BIOSCIENCE, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
December 31, December 31,
2024 2023
ASSETS
Current assets
Cash and cash equivalents $ 68,415,741 $ 1,256,453
Restricted cash -- 9,080,202
Prepaid expenses 201,962 194,259
Other current assets 2,209,544 1,119,929
------------ ------------
Total current assets 70,827,247 11,650,843
Property and equipment, net 1,432,752 43,276
Operating lease right-of-use asset 449,864 237,983
Other assets 53,910 8,309
------------ ------------
Total assets $ 72,763,773 $ 11,940,411
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT)
Current liabilities
Accounts payable $ 569,252 $ 956,754
Accrued interest - related party -- 126,027
Accrued interest - legal
contingency -- 234,750
Accrued payroll liabilities 1,114,255 888,381
Other current liabilities 654,201 991,805
Estimate for accrued legal
contingencies and related
expenses 1,818,751 6,259,246
Convertible note - related party,
net of discount -- 4,371,998
Operating lease liability, current
portion 182,428 72,038
------------ ------------
Total current liabilities 4,338,887 13,900,999
Non-current liabilities
Operating lease liability, net of
current portion 273,162 171,230
------------ ------------
Total liabilities 4,612,049 14,072,229
------------ ------------
Commitments and contingencies
Stockholders' equity (deficit)
Preferred stock, $0.001 par value;
200,000 shares authorized at
December 31, 2024 and December 31,
2023; no shares issued and
outstanding at December 31, 2024
and December 31, 2023 -- --
Common stock, $0.001 par value;
100,000,000 shares authorized at
December 31, 2024 and December
31, 2023; 30,974,559 and
12,349,243 shares issued and
outstanding at December 31, 2024
and December 31, 2023,
respectively 30,975 12,349
Additional paid-in-capital 199,070,421 102,238,382
Accumulated deficit (130,949,672) (104,382,549)
------------ ------------
Total stockholders' equity
(deficit) 68,151,724 (2,131,818)
------------ ------------
Total liabilities and
stockholders' equity
(deficit) $ 72,763,773 $ 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
(END) Dow Jones Newswires
March 20, 2025 16:01 ET (20:01 GMT)
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