Artelo Biosciences, Inc 10-Q for FY2025 Q2

Artelo Biosciences, Inc. (ARTL)

10-Q 2025-08-13 For: 2025-06-30

Added on April 10, 2026

About this 10-Q

Artelo Biosciences, Inc filed this 10-Q on August 13, 2025, covering the quarter ended June 30, 2025 (FY2025 Q2).

Headline figures

Quarter ended June 30, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $3.22M; compared with a net loss of $2.43M a year earlier
Diluted EPS: -$5.61; compared with -$4.52 a year earlier

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Nevada		33-1220924
(State or other jurisdiction of incorporation or organization)		(IRS Employer Identification No.)

505 Lomas Santa Fe, Suite 160, Solana Beach, CA USA		92075
(Address of principal executive offices)		(Zip Code)

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.001 par value per share	ARTL	The Nasdaq Stock Market, LLC

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

PART I - FINANCIAL INFORMATION

Item 1.	Financial Statements	3
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	30
Item 4.	Controls and Procedures	30

PART II - OTHER INFORMATION

Item 1.	Legal Proceedings	31
Item 1A.	Risk Factors	31
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	71
Item 3.	Defaults Upon Senior Securities	71
Item 4.	Mine Safety Disclosures	71
Item 5.	Other Information	71
Item 6.	Exhibits	72

SIGNATURES		73

	June 30,			December 31,
	2025			2024

ASSETS
Current Assets
Cash and cash equivalents	$	2,066		$	2,338
Prepaid expenses and other current assets		167			219
Total Current Assets		2,233			2,557
Operating lease right-of-use assets		82			99
Intangible asset		2,039			2,039
Other assets		3			3
TOTAL ASSETS	$	4,357		$	4,698

LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities
Accounts payable and accrued liabilities	$	4,841		$	1,676
Accrued interest – convertible notes		18			-
Due to related parties		26			61
Operating lease liabilities - current portion		36			35
Convertible notes		791			-
Total Current Liabilities		5,712			1,772

Operating lease liabilities		51			69
TOTAL LIABILITIES		5,763			1,841

STOCKHOLDERS' EQUITY
Preferred Stock, par value $0.001, 69,445 shares authorized, 0 shares issued and outstanding as of June 30, 2025 and December 31, 2024		-			-
Common Stock, par value $0.001, 8,333,333 shares authorized and 704,425 and 567,582 shares issued and outstanding as of June 30, 2025, and December 31, 2024, respectively		1			1
Additional paid-in capital		54,617			53,194
Accumulated deficit		(55,729	)		(50,136	)
Accumulated other comprehensive loss		(295	)		(202	)
TOTAL STOCKHOLDERS' (DEFICIT) EQUITY		(1,406	)		2,857

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$	4,357		$	4,698

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

	For the quarterly period ended: June 30, 2025

☐	TRANSITION REPORT PERSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

	For the transition period from ___________ to ___________

	Three months ended						Six months ended
	June 30,						June 30,
	2025			2024			2025			2024

OPERATING EXPENSES
General and administrative	$	1,279		$	827		$	2,274		$	1,909
Research and development		1,871			1,685			3,255			3,192
Total Operating Expenses		3,150			2,512			5,529			5,101

Loss from Operations		(3,150	)		(2,512	)		(5,529	)		(5,101	)

OTHER INCOME (EXPENSE)
Interest income		1			-			8			-
Interest expense		(72	)		-			(72	)		-
Net change in fair value of trading marketable securities		-			79			-			185
Total other income		(71	)		79			(64	)		185

Provision for income taxes		-			-			-			-

NET LOSS	$	(3,221	)	$	(2,433	)	$	(5,593	)	$	(4,916	)

OTHER COMPREHENSIVE INCOME (LOSS)
Foreign currency translation adjustments		(68	)		-			(93	)		-
Total Other Comprehensive Income (Loss)		(68	)		-			(93	)		-

TOTAL COMPREHENSIVE LOSS	$	(3,289	)	$	(2,433	)	$	(5,686	)	$	(4,916	)

Basic and Diluted Loss per Common Share	$	(5.61	)	$	(4.52	)	$	(9.80	)	$	(9.17	)

Basic and Diluted Weighted Average Common Shares Outstanding		574			538			571			536

					Additional					Accumulated Other
	Common stock				Paid-in		Accumulated			Comprehensive
	Shares		Amount		Capital		Deficit			Income (loss)			Total

Balance, December 31, 2024		567	$	1	$	53,194	$	(50,136	)	$	(202	)	$	2,857

Common shares issued for cash		-		-		-		-			-			-
Stock based compensation		-		-		192		-			-			192
Net loss for the period		-		-		-		(2,372	)		-			(2,372	)
Other comprehensive loss		-		-		-		-			(25	)		(25	)
Balance, March 31, 2025		567	$	1	$	53,386	$	(52,508	)	$	(227	)	$	652

Common shares issued for cash, net of issuance costs		137		-		1,081		-			-			1,081
Stock based compensation		-		-		150		-			-			150
Net loss for the period		-		-		-		(3,221	)		-			(3,221	)
Other comprehensive loss		-		-		-		-			(68	)		(68	)
Balance, June 30, 2025		704	$	1	$	54,617	$	(55,729	)	$	(295	)	$	(1,406	)

(a)	Consists of sales and marketing, investor relations, travel and other office expenses.

(b)	Consists of supplies and other items used in research and development activities.

					Weighted
	Number of		Weighted Average		Average
	shares		Exercise Price		Life (years)
Outstanding, December 31, 2024		23,315	$	67.50		0.79
Granted		783,249		6.36		5.00
Expired		-		-		-
Exercised		-		-		-
Outstanding, June 30, 2025		806,564	$	8.12		4.85

	Options Outstanding				Weighted Average
	Number of		Weighted Average		Remaining life
	Options		Exercise Price		(years)
Outstanding, December 31, 2024		128,976	$	11.02		7.76
Granted		-		-		-
Exercised		-		-		-
Forfeited/canceled		-		-		-
Outstanding, June 30, 2025		128,976	$	11.02		7.26

Exercisable options, June 30, 2025		54,629	$	13.69		7.10

	Total
Year Ended December 31,
2025	$	21
2026		43
2027		30
2028		-
Thereafter		-
		94
Less: Imputed interest		(6	)
Operating lease liabilities		88

Operating lease liability - current		38
Operating lease liability - non-current	$	50

	·	The Company is invoiced monthly and quarterly in connection with several research and development contracts.
	·	The Company may be obligated to make additional payments related to research and development contracts entered into, dependent on the progress and milestones achieved through the programs.
	·	The Company’s principal executive office is currently located at 505 Lomas Santa Fe Drive, Suite 160, Solana Beach, CA, US. Additionally, we have an office outside Manchester, UK, which serves as administrative spaces for managing our subsidiaries, Trinity Reliant Ventures, Ltd (Ireland) and Artelo Biosciences Limited (UK). We do not currently own any properties, laboratories, or manufacturing facilities. The Solana Beach lease runs through August 2027 and the Manchester UK lease is month-to-month.
	·	The Company agreed that $250 of the proceeds of the financing closed June 26, 2025, will be used to purchase SOL.

	·	our financial condition and our ability to continue as a going concern;

	·	our plans to obtain funding for our operations, including funding necessary to complete our clinical trials, develop, manufacture and commercialize our product candidates;

	·	our Digital Asset Treasury strategy pursuant to which we anticipate purchasing the digital currency known as Solana (“SOL”);

	·	our ability to raise any current or future funding to meet our capital requirements;

	·	the expected timing of the initiation and completion of our clinical studies for our product candidates;

	·	the size and growth of the markets for our product candidates;

	·	our commercialization, marketing, and manufacturing capabilities and strategies;

	·	geopolitical tensions, including tariffs and any war, regional conflict, or acts of terror, that can disrupt investment, supply chains and the economy generally;

	·	our ability to compete with companies currently producing alternative treatment methods;

	·	the cost, timing and outcomes of any potential litigation involving our product candidates;

	·	regulatory developments in the U.S. and internationally;

	·	the development, regulatory approval, efficacy and commercialization of competing product candidates;

	Six Months ended
	June 30,
	2025		2024

General and administrative
Employee and director compensation	$	471	$	474
Stock-based compensation		200		273
Professional fees		1,037		553
Other general and administrative ^(a)		566		609
Total general and administrative		2,274		1,909

	Six months ended
	June 30,
	2025			2024

Lease cost
Operating lease cost	$	17		$	16

Other information
Cash paid for operating cash flows from operating leases	$	17		$	14
Right-of-use assets obtained in exchange for new operating lease liability	$	-		$	111

Weighted-average remaining lease term — operating leases (year)		2.08			3.33
Weighted-average discount rate — operating leases		7.50	%		7.50	%

	·	our ability to attract and retain key scientific or management personnel;

	·	the scope of protection we are able to establish and maintain for intellectual property rights covering our products and technology;

	·	the terms and conditions of licenses granted to us and our ability to license additional intellectual property related to our product candidates, as appropriate;

	·	potential claims related to our intellectual property;

	·	the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

	·	our ability to regain and maintain compliance with Nasdaq listing requirements;

	·	our ability to develop and maintain our corporate infrastructure, including our internal controls;

	·	our cash investment strategy;

	·	our ability to develop innovative new product candidates; and

	·	our financial performance.

	·	*DAT Strategy. We have adopted a Digital Asset Treasury strategy whereby we will purchase the digital currency known as Solana (“SOL”). As of August 6, 2025, the Company has* expended $250,000 to purchase SOL.

	·	August 2025 Private Placement. On August 4, 2025, we entered into a securities purchase agreement for an at-the market PIPE (private investment in public equity) for the purchase and sale of securities at a price of $10.45 per security, consisting of: (a) 906,687 shares of common stock (or pre-funded warrants in lieu thereof); (b) three-year warrants to purchase 906,687 shares of common stock at an exercise price of $10.20 per share; and (c) three-year warrants to purchase 906,687 shares of common stock at an exercise price of $50.00 per share, for expected aggregate gross proceeds of approximately $9.475 million. We agreed that the net proceeds of the sale will be used to purchase Solana (“SOL”).

	·	ATM Sales Agreement. On July 18, 2025, we entered into an At-The-Market Offering Agreement (the “Sales Agreement”) with R.F. Lafferty & Co., Inc. (“R.F. Lafferty”) under which we may offer and sell up to $6.5 million of shares of our common stock from time to time through an “at the market” offering program under which R.F. Lafferty will act as sales agent. Under the Sales Agreement, we will set the parameters for the sale of shares, including the number or dollar amount of shares to be issued, the time period during which sales are requested to be made, limitations on the number or dollar amount of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, R.F. Lafferty may sell the shares by methods deemed to be an “at the market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. We have no obligation to sell any shares under the Sales Agreement and may at any time suspend solicitation and offers under the Sales Agreement. The shares will be issued pursuant to our shelf registration statement on Form S-3, including the prospectus supplement contained therein, which was declared effective by the SEC on July 14, 2023. As of August 11, 2025, 4,580 common stock shares have been sold under the ATM for net proceeds of $47,000.

	·	June 2025 Private Placement. On June 26, 2025, we completed a private placement (the “Private Placement”) of (i) 136,843 shares (the “Shares”) of our common stock, par value $0.001 per share (the “Common Stock”), at $5.82 per share, (ii) pre-funded warrants to purchase 93,180 shares of Common Stock at an exercise price of $0.001 per Share (the “Pre-Funded Warrants”) at $5.819 per Pre-Funded Warrant, (iii) warrants to purchase 460,046 shares of Common Stock at an exercise price of $5.82 per share (the “$5.82 Warrants”), and (iv) warrants to purchase 230,023 shares of Common Stock at an exercise price of $10.00 per share (the “$10.00 Warrants”). The Pre-Funded Warrants, the $5.82 Warrants and the $10.00 Warrants are collectively referred to herein as the “Warrants” and the shares issuable upon such Warrants, the “Warrant Shares.” Gross proceeds were $1.425 million.

	·	*Reverse Stock Split.* On June 12, 2025, we filed with the Secretary of State of the State of Nevada a Certificate of Change (the “Certificate of Change”), pursuant to Nevada Revised Statutes 78.209, to effect a one-for-six (1-for-6) reverse stock split (the “Reverse Split”) of our issued and outstanding common stock, par value $0.001 per share (the “Common Stock”). The Reverse Split was effective as of 12:01 a.m. Eastern Time on June 13, 2025 (the “Effective Time”). Pursuant to the Nevada Revised Statutes 78.207, our board of directors has the authority to effect a reverse stock split without stockholder approval if the number of authorized shares of common stock and the number of outstanding shares of common stock are proportionally reduced.

	·	Asset. SOL only.

	·	Source of funds. (i) $250,000 of proceeds from the June 2025 private placement offering of equity securities and (ii) all net cash proceeds from the $9.4 million August 2025 private placement offering.

	·	Execution. Spot purchases for cash on U.S. venues that are registered or chartered, and subject to BSA/AML obligations. No leverage, margin, or derivatives are permitted.

	·	Custody. The initial $250,000 in SOL acquired pursuant to the June 2025 private placement offering is held in custody with BitGo, a U.S.-regulated, qualified digital-asset custodian. Certain amounts of SOL acquired with proceeds from the August 2025 private placement offering, are held with CUBE, a U.S.-regulated, qualified digital-asset custodian that provides segregated, cold-storage accounts, multi-signature authorization, SOC-2 reporting, and a limited insurance program.

	·	Private keys are maintained exclusively with BitGo and CUBE; we do not self-custody.

	·	Use of SOL. Our holdings are maintained as a long-term, non-core treasury reserve asset. No SOL has been loaned, staked, pledged, or otherwise encumbered.

	·	Reporting. Our holdings are measured at fair value pursuant to ASU 2023-08. Changes in fair value flow through net income each reporting period. The Audit Committee will receive reports covering holdings, valuation, counter-party exposure, and compliance with Board resolutions on a quarterly or more frequent basis.

	·	Liquidity & Working-Capital Treatment. Although SOL is not treated as cash, cash equivalents, or a financial asset for Nasdaq continued-listing standards, the private placements described above increased shareholder equity. We will attempt to establish and maintain a separate reserve of liquid cash resources sufficient to fund at least twelve months of projected operating expenses to support ongoing biopharmaceutical development activities, without relying on the sale of digital assets. Seeking to maintain this twelve-month operating runway will support regulatory compliance, mitigate liquidity risk, and provide assurance to auditors and stakeholders that our core biopharmaceutical operations remain fully funded.

	·	Our historical financial statements do not reflect the potential variability in earnings that we may experience in the future from holding or selling significant amounts of SOL. The prices of digital assets have historically been subject to dramatic price fluctuations and are highly volatile. In December 2023, the Financial Accounting Standards Board issued Accounting Standards Update 2023-08, Intangibles-Goodwill and Other-Crypto Assets (Subtopic 350-60): Accounting for and Disclosure of Crypto Assets (“ASU 2023-08”), which we are required to adopt under GAAP. ASU 2023-08 requires us to measure our SOL holdings at fair value in our statement of financial position, and to recognize gains and losses from changes in the fair value of our SOL in net income each reporting period. ASU 2023-08 also requires us to provide certain interim and annual disclosures with respect to our SOL holdings. As a result, volatility in our earnings may be significantly more than what we experienced in prior periods.

	·	We expect to continue to incur future R&D expenses associated with the continued development of our drug candidates. The level of expenses will be highly dependent upon the scope of pre-clinical and clinical development activities and strategies, and will also be directly dependent upon the level of our available funding for R&D activities.

	·	We expect to continue to incur general and administrative expenses in the future, which are expected, in the near-term, to be broadly comparable to the level of general and administrative expenses incurred year-to-date.

	Three months ended
	June 30,
(In thousands)	2025			2024			Change
Operating Expenses
General and administrative	$	1,279		$	827		$	452
Research and development		1,871			1,685			186
Total Operating Expenses		3,150			2,512			638
Loss from Operations		(3,150	)		(2,512	)		(638	)
Other income		(71	)		79			(150	)
Net Loss	$	(3,221	)	$	(2,433	)	$	(788	)

	·	continue our research and development activities;

	·	maintain, protect and expand our intellectual property portfolio, including patents, trade secrets and know how;

	·	implement operational, financial and management information systems;

	·	attract, hire and retain additional management, scientific and administrative personnel; and

	·	operate as a public company.

	·	We will need to raise additional financing to support our business objectives. We cannot be sure we will be able to obtain additional financing on terms favorable to us when needed, or at all. If we are unable to obtain additional financing to meet our needs, our operations may be adversely affected or terminated.

	·	We are currently receiving Research and Development, or R&D, tax credits from the UK in connection with our clinical trials being conducted in the UK. With effect for accounting periods starting on or after April 1, 2024, expenditure on certain staffing costs in connection with activities which take place outside the UK as part of our clinical trials, will not qualify for R&D tax credits unless restrictive conditions are met.

	·	If we fail to comply with our obligations under our patent licenses with third parties, we could lose license rights that are vital to our business.

	·	Changes in regulatory requirements or other unforeseen circumstances may impact the timing of the initiation or completion of our clinical trials.

	·	We face many of the risks and difficulties frequently encountered by relatively new companies with respect to our operations.

	·	We have no mature product candidates and may not be successful in licensing any.

	·	Even if we are successful in licensing lead product candidates, resource limitations may limit our ability to successfully develop them.

	·	SOL is a highly volatile asset, and fluctuations in the price of SOL may influence our financial results and the market price of our listed securities.

	·	SOL and other digital assets are novel assets and are subject to significant legal and regulatory uncertainty.

	·	Our SOL digital asset holdings may not be recognized as cash or financial assets under Nasdaq listing standards, which could jeopardize our continued listing and adversely affect the liquidity and market price of our Common Stock.

	·	Our Solana treasury strategy could divert resources and attention away from our biopharmaceutical business and adversely affect our operations.

	·	Our SOL treasury strategy subjects us to enhanced regulatory oversight.

	·	We plan to use a portion of our capital raised that is not required to provide working capital for our ongoing operations to acquire SOL, which may adversely affect our financial results and the market price of our securities.

	·	If we were deemed to be an investment company under the Investment Company Act, applicable restrictions likely would make it impractical for us to continue segments of our business as currently contemplated.

	·	We face risks relating to the custody of SOL, including the loss or destruction of private keys required to access SOL and cyberattacks or other data loss relating to SOL, including smart contract related losses and vulnerabilities.

	·	Due to the unregulated nature and lack of transparency surrounding the operations of many SOL trading venues, SOL trading venues may experience greater fraud, security failures or regulatory or operational problems than trading venues for more established asset classes, which may result in a loss of confidence in SOL trading venues and adversely affect the value of SOL.

	·	Our SOL holdings will be less liquid than our cash and cash equivalents and may not be able to serve as a source of liquidity for us to the same extent as cash and cash equivalents.

	·	If we are unable to obtain and maintain patent protection for our products, our competitors could develop and commercialize products and technology similar or identical to our product candidates, and our ability to successfully commercialize any product candidates we may develop, and our science may be adversely affected.

	·	Obtaining and maintaining our patent protection depends on compliance with various procedural measures, document submissions, fee payments and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

	·	We may be subject to claims challenging the inventorship of our patents and other intellectual property.

	·	Intellectual property rights do not necessarily address all potential threats.

	·	Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.

	·	Our Common Stock may be delisted from The Nasdaq Capital Market if we cannot maintain compliance with Nasdaq’s continued listing requirements.

	·	If we sell securities in future financings stockholders may experience immediate dilution and, as a result, our stock price may decline.

	·	The price of our securities may be volatile, and you could lose all or part of your investment. Further, we do not know whether an active, liquid and orderly trading market will continue for our securities or what the market price of our securities will be and as a result it may be difficult for you to sell your shares of our securities.

	·	Any market activity involving short selling or other market making activities could result in negative impact to the market price for our Common Stock.

	·	A sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.

	·	We could be subject to securities class action litigation.

	·	Shares of our Common Stock that have not been registered under federal securities laws are subject to resale restrictions imposed by Rule 144, including those set forth in Rule 144(i) which apply to a former “shell company.”

	·	Sales of our currently issued and outstanding stock may become freely tradable pursuant to Rule 144 and sales of such shares may have a depressive effect on the share price of its Common Stock.

	·	the costs related to initiation, progress, timing, and results of preclinical studies and clinical trials for our product candidates;

	·	any change in the clinical development plans for these product candidates;

	·	the number and characteristics of product candidates that we develop or acquire;

	·	our ability to establish and maintain strategic collaborations, licensing or other commercialization arrangements and the terms and timing of such arrangements;

	·	the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of other products or treatments;

	·	the events related to the outcome, timing and cost of meeting regulatory requirements established by the U.S. Drug Enforcement Agency (the “DEA”), the FDA or other comparable foreign regulatory authorities;

	·	the potential costs of filing, prosecuting, defending and enforcing our patent claims and other intellectual property;

	·	changes in economic conditions, including recessionary effects and inflationary pressures;

	·	the costs associated with attracting and retaining skilled personnel;

	·	the costs associated with being a public company;

	·	the cost of defending intellectual property disputes; and

	·	the cost of marketing and generating revenues for any of our product candidates.

	·	our research and development efforts, including preclinical studies and clinical trials of our product candidates;

	·	developing sustainable, scalable, reliable and cost-effective manufacturing and distribution processes for our product candidates, including establishing and maintaining commercially viable supply relationships with third parties and establishing our own cGMPs, manufacturing facilities and processes;

	·	addressing any competing technological and industry developments;

	·	identifying, assessing, acquiring and/or developing new technology platforms and product candidates across numerous therapeutic areas;

	·	obtaining regulatory approvals and marketing authorizations for product candidates;

	·	launching and commercializing any approved products, either directly or with a collaborator or distributor;

	·	obtaining market acceptance of and acceptable reimbursement for any approved products;

	·	completing collaborations, licenses and other strategic transactions on favorable terms, if at all;

	·	maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; and

	·	attracting, hiring and retaining qualified personnel.

	·	identifying, licensing and obtaining development programs and lead candidates;

	·	conducting initial research required to identify a lead candidate as the result of intellectual property we have licensed;

	·	initiating preclinical, clinical or other required studies for future product candidates;

	·	adding manufacturers and suppliers required to advance our programs;

	·	obtaining regulatory and marketing approvals for our product candidates that successfully complete clinical studies;

	·	making milestone or other payments under any license agreements;

	·	expanding, maintaining and protecting our intellectual property portfolio;

	·	attracting and retaining skilled personnel; and

	·	creating and maintaining an infrastructure required to support our operations as a public company.

	·	generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical trials;

	·	obtain regulatory approval, or feedback on clinical trial design, to commence a clinical trial;

	·	identify, recruit and train suitable clinical investigators;

	·	reach agreement on acceptable terms with prospective CROs and clinical trial sites;

	·	obtain and maintain IRB, approval at each clinical trial site;

	·	identify, recruit, and enroll suitable patients to participate in a clinical trial;

	·	have a sufficient number of patients complete a clinical trial or return for post-treatment follow-up;

	·	ensure clinical investigators observe clinical trial protocol or continue to participate in a clinical trial;

	·	address any patient safety concerns that arise during the course of a clinical trial;

	·	address any conflicts with new or existing laws or regulations;

	·	add a sufficient number of clinical trial sites;

	·	timely manufacture sufficient quantities of a product candidate for use in clinical trials; or

	·	raise sufficient capital to fund a clinical trial.

	·	lack of effectiveness of any formulation or delivery system during clinical trials;

	·	discovery of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues;

	·	slower than expected rates of subject recruitment and enrollment rates in clinical trials;

	·	delays or inability in manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to regulatory and manufacturing constraints;

	·	delays in obtaining regulatory authorization to commence a trial, including IRB or Ethics Committee approvals, licenses required for obtaining and using cannabinoids for research, either before or after a trial is commenced;

	·	unfavorable results from ongoing non-clinical studies and clinical trials;

	·	patients or investigators failing to comply with study protocols;

	·	patients failing to return for post-treatment follow-up at the expected rate;

	·	sites participating in an ongoing clinical study withdraw, requiring us to engage new sites;

	·	third-party clinical investigators decline to participate in our clinical studies, do not perform the clinical studies on the anticipated schedule, or act in ways inconsistent with the established investigator agreement, clinical study protocol, good clinical practices, and other IRB requirements;

	·	third-party entities do not perform data collection and analysis in a timely or accurate manner or at all; or

	·	regulatory inspections of our clinical studies require us to undertake corrective action or suspend or terminate our clinical studies.

●	decreased user and purchaser confidence in SOL, including due to the various factors described herein;

●	transactional activities such as (i) activities of highly active retail and institutional users, speculators and holders or (ii) actual or expected significant dispositions of SOL by large holders, including the expected liquidation of digital assets seized by governments or associated with entities that have filed for bankruptcy protection;

●	negative publicity, media or social media coverage, or sentiment due to events in or relating to, or perception of, SOL or the broader digital assets industry;

●	changes in consumer preferences and the perceived value or prospects of SOL;

●	competition from other blockchains, centralized exchanges or decentralized exchanges that exhibit comparable or better speed, security, scalability or energy efficiency, or that feature other more favored characteristics;

●	competition from other digital assets that feature other more favored characteristics, are backed by governments, including the U.S. government, or reserves of fiat currencies, or that represent ownership or security interests in physical assets;

●	a decrease in the price of other digital assets, to the extent the decrease in the price of such other digital assets may cause a decrease in the price of SOL or adversely affect investor confidence in digital assets generally;

●	disruptions, failures, unavailability, or interruptions in services of venues for acquiring SOL;

●	the filing for bankruptcy protection by, liquidation of, or market concerns about the financial viability of digital asset custodians, trading venues, lending platforms, investment funds, or other digital asset industry participants;

●	transaction congestion and fees associated with processing transactions on the SOL network;

●	macroeconomic changes, such as changes in the level of interest rates and inflation, fiscal and monetary policies of governments, trade restrictions and fiat currency devaluations;

●	developments in mathematics or technology, including in digital computing, algebraic geometry and quantum computing, that could result in the cryptography used by the SOL blockchain becoming insecure or ineffective; and

●	changes in national and international economic and political conditions, including, without limitation, federal government policies, trade tariffs and trade disputes, and the adverse impacts attributable to global conflicts, including those between Russia and Ukraine, China and Taiwan, and in the Middle East.

●	President Donald J. Trump signed an Executive Order instructing a working group comprised of representatives from key federal agencies to evaluate measures that can be taken to provide regulatory clarity and certainty built on technology-neutral regulations for individuals and firms involved in digital assets, including through well-defined jurisdictional regulatory boundaries, and this working group is required to submit a report with regulatory and legislative proposals on or before July 22, 2025;

●	in January 2025, the SEC announced the formation of a “Crypto Task Force,” which was created to provide clarity on the application of the federal securities laws to the crypto asset market and to recommend policy measures with respect to digital asset security status, registration and listing of digital asset-based investment vehicles, and digital asset custody, lending and staking;

●	in May 2025, the SEC issued a statement providing its view that certain staking activities on blockchain networks that use protocol staking activities do not involve the offer or sale of securities under the Securities Act or the Exchange Act;

●	in April and August 2024, Uniswap Labs and OpenSea, respectively, publicized that they had each received a Wells Notice from the SEC, notifying them that the SEC was planning to recommend legal action against them based on allegations that they operate as unregistered securities exchanges;

●	in November 2023, Binance Holdings Ltd. (“Binance”) and its then chief executive officer reached a settlement with the U.S. Department of Justice, the Commodity Futures Trading Commission, the U.S. Department of Treasury’s Office of Foreign Asset Control, and the Financial Crimes Enforcement Network to resolve a multi-year investigation by the agencies and a civil suit brought by the Commodity Futures Trading Commission, pursuant to which Binance agreed to, among other things, pay $4.3 billion in penalties across the four agencies and to discontinue its operations in the United States;

●	in November 2023, the SEC filed a complaint against Payward Inc. and Payward Ventures Inc., together known as Kraken, alleging, among other claims, that Kraken’s crypto trading platform was operating as an unregistered securities exchange, broker, dealer and clearing agency;

●	in June 2023, the SEC filed complaints against Binance and Coinbase, Inc. (“Coinbase”), and their respective affiliated entities, relating to, among other claims, assertions that each party was operating as an unregistered securities exchange, broker, dealer and clearing agency;

●	the European Union adopted Markets in Crypto Assets Regulation, a comprehensive digital asset regulatory framework for the issuance and use of digital assets, like bitcoin;

●	in June 2023, the United Kingdom adopted and implemented the Financial Services and Markets Act 2023, which regulates market activities in “cryptoassets;” and

●	in China, the People’s Bank of China and the National Development and Reform Commission have outlawed cryptocurrency mining and declared all cryptocurrency transactions illegal within the country.

	·	others may be able to make products that are similar to our product candidates or utilize similar science or technology but that are not covered by the claims of the patents that we may own or license from our licensors or that incorporate certain research in our product candidates that is in the public domain;

	·	we, or our licensors or collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we or our licensors own now or in the future;

	·	we, or our licensors or collaborators, might not have been the first to file patent applications covering certain of our or their inventions;