EXHIBIT 99.1 ARTELO BIOSCIENCES, INC. INDEX TO AUDITED FINANCIAL STATEMENTS | | Page | | --- | --- | | Report of Independent Registered Public Accounting Firm (PCAOB ID 206). | 2 | | Consolidated Balance Sheets at December 31, 2024 and 2023. | 3 | | Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2024 and 2023. | 4 | | Consolidated Statements of Stockholders' Equity for the years ended December 31, 2024 and 2023. | 5 | | Consolidated Statements of Cash Flows for ...

Core Insights - Artelo Biosciences, Inc. presented preclinical data on its lead fatty acid binding protein 5 (FABP5) inhibitor, ART26.12, at the 35th Annual International Cannabinoid Research Society Symposium, demonstrating its potential to alleviate osteoarthritis (OA) pain [1][2][5] Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing treatments that modulate lipid-signaling pathways for various conditions, including cancer, pain, and neurological disorders [7] - The company is advancing a portfolio of product candidates aimed at addressing significant unmet medical needs across multiple diseases [7] Product Development - ART26.12 is a first-in-class, non-opioid, non-steroidal analgesic drug candidate that has shown significant efficacy in alleviating OA pain in preclinical models [2][3] - The drug demonstrated comparable efficacy to naproxen, a commonly prescribed NSAID, without developing tolerance over a four-week chronic dosing period [3][5] - ART26.12's administration led to increased plasma levels of endocannabinoids 2-Arachidonoylglycerol (2-AG) and Oleoylethanolamide (OEA), which were positively correlated with pain relief [3] Safety Profile - ART26.12 may offer a safer alternative to NSAIDs, which are associated with gastrointestinal side effects in about one-third of patients and a five-fold increase in gastric ulcer complications [4] - The distinct pharmacological profile of ART26.12 suggests it could provide ongoing pain relief without the adverse effects commonly seen with NSAIDs [4][5] Research Collaboration - The research on ART26.12 was conducted in collaboration with Stony Brook University, highlighting the company's commitment to translational research [3][5] Market Context - Osteoarthritis affects approximately 606.9 million people globally, with over 32 million in the U.S., indicating a significant market opportunity for effective pain management solutions [9]

Core Viewpoint - Artelo Biosciences, Inc. has been upgraded from Hold to Buy by D. Boral Capital, with a price target of $20, highlighting its focus on Cachexia and chemotherapy-induced peripheral neuropathy (CIN) [1] Group 1: Drug Development and Pipeline - ART27.13, a Phase 2 asset, is a selective benzimadazole agonist acquired from AstraZeneca, showing potential to stimulate appetite and promote weight gain, which could improve the quality of life for cancer patients [1][2] - ART26.12, another asset licensed from the University of Stonybrook, appears to protect nerves from damage without compromising chemotherapy efficacy, with favorable results from its first-in-human study affirming its safety and pharmacokinetic profile [3] - New preclinical data on ART12.11, a Cannabidiol and Tetramethylpyrazine cocrystal drug candidate, was presented, indicating its potential for treating depression and anxiety, particularly in patients with cognitive dysfunction [4][6] Group 2: Efficacy and Market Position - ART12.11 demonstrated significant behavioral improvements in male rats under chronic stress, showing efficacy comparable to sertraline (Zoloft), a leading SSRI, while also reversing stress-induced memory deficits [6][7] - Artelo Biosciences stock increased by 14.66% to $16.42 following these developments, reflecting positive market sentiment [6]

Core Insights - Artelo Biosciences, Inc. presented new preclinical data on its drug candidate ART12.11, a cocrystal of Cannabidiol (CBD) and Tetramethylpyrazine (TMP), at the 35th Annual International Cannabinoid Research Society Symposium, indicating its potential as a next-generation antidepressant [1][2][3] Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing treatments for various conditions, including cancer, pain, and neurological disorders, by modulating lipid-signaling pathways [1][9] - The company is advancing a portfolio of therapeutics aimed at addressing significant unmet medical needs across multiple diseases [9] Product Details - ART12.11 is a proprietary cocrystal composition that has shown better pharmacokinetics and efficacy compared to other forms of CBD in nonclinical studies [6][8] - The drug demonstrated robust antidepressant-like effects in a 28-day treatment regimen, significantly reversing behavioral impairments in stressed male rats, comparable to the leading SSRI sertraline [7] - ART12.11 not only restored mood-related behaviors but also reversed cognitive deficits associated with chronic stress, an area where sertraline was less effective [4][7] Research Findings - The preclinical studies indicated that ART12.11 improved depression-related behaviors and cognitive functions, positioning it as a differentiated candidate in the multi-billion-dollar antidepressant market [2][5][7] - The cocrystal's unique dual-action profile suggests it could meet critical needs in mental health by providing both mood-lifting and cognitive benefits [6][7] Intellectual Property - The US issued a composition of matter patent for ART12.11, enforceable until December 10, 2038, with additional patents granted or validated in 19 other countries [8]

Core Insights - Artelo Biosciences, Inc. has announced favorable results from its first-in-human study of ART26.12, a novel inhibitor of Fatty Acid Binding Protein 5 (FABP5), which shows promising safety and pharmacokinetic profiles [1][4][5] Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing treatments that modulate lipid-signaling pathways for various conditions including cancer and pain [1][8] - The company is advancing a portfolio of therapeutics aimed at addressing significant unmet needs in multiple diseases and conditions [8] Product Development - ART26.12 is the first orally administered, selective, and peripherally restricted FABP5 inhibitor to enter human clinical evaluation, targeting chronic pain management [4][5] - The Phase 1 Single Ascending Dose (SAD) study enrolled 49 healthy volunteers to assess the safety, tolerability, and pharmacokinetics of ART26.12 [2][5] Market Opportunity - The chronic pain therapeutics market exceeded $97 billion globally in 2023 and is projected to surpass $159 billion by 2030, driven by increasing prevalence of conditions such as neuropathic pain and arthritis [5] - There is a significant gap in innovation for non-opioid therapies in the pain management market, which ART26.12 aims to fill with its unique mechanism of action [5] Safety and Efficacy Findings - All adverse events reported in the study were mild, transient, and self-resolving, with no drug-related adverse events observed [7] - The pharmacokinetic profile showed dose-dependent, linear absorption, indicating a predictable response to the drug [7] - A wide safety margin was observed between estimated therapeutic plasma concentrations and the highest exposure levels achieved, supporting potential titration for maximum efficacy [7] Future Development Plans - A Multiple Ascending Dose study is expected to commence in the fourth quarter of this year to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 with repeated dosing [5]

Core Viewpoint - Artelo Biosciences, Inc. has entered into a definitive securities purchase agreement for an At-the-Market private placement, aiming to raise approximately $1.425 million to support clinical data announcements and general corporate purposes [1][2]. Group 1: Securities Offering Details - Artelo will issue 136,844 shares of common stock and 93,179 pre-funded warrants, along with warrants to purchase 460,046 shares at $5.82 per share and 230,023 shares at $10.00 per share [2]. - The offering aims to provide sufficient capital for announcing clinical data regarding two phase 1 studies for ART26.12 and a phase 2 study readout from the CAReS trial for ART27.13 [2]. - The company plans to allocate $250,000 of the net proceeds to purchase the digital currency SOL, with the remainder for general corporate and working capital purposes [2]. Group 2: Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing treatments that modulate lipid-signaling pathways for various conditions, including cancer, pain, and dermatological issues [4]. - The company is advancing a portfolio of product candidates aimed at addressing significant unmet medical needs across multiple diseases [4]. - Artelo is led by experienced biopharmaceutical executives and collaborates with respected researchers and technology experts to develop impactful therapies [4].

Core Viewpoint - Artelo Biosciences, Inc. has announced a 6-for-1 reverse stock split to increase the price per share to meet Nasdaq's minimum listing requirement of $1.00 per share, effective June 13, 2025 [1][2]. Company Overview - Artelo Biosciences, Inc. is a clinical-stage pharmaceutical company focused on developing treatments that modulate lipid-signaling pathways for various conditions including cancer, pain, and dermatological issues [3]. - The company is advancing a portfolio of product candidates aimed at addressing significant unmet medical needs across multiple diseases [3]. Reverse Stock Split Details - The reverse stock split will automatically convert every six shares of the company's common stock into one share, maintaining shareholders' pro-rata ownership [2]. - Post-split, approximately 546,667 shares of common stock will be issued and outstanding [2].

Core Insights - Artelo Biosciences, Inc. presented new data at the British Pain Conference, highlighting the therapeutic potential of Fatty Acid Binding Protein (FABP) inhibitors for treating osteoarthritis (OA) pain [1][2] - The lead FABP5 inhibitor, ART26.12, demonstrated analgesic effects comparable to naproxen in animal studies, with sustained effects over 28 days [4][3] - OA affects approximately 606.9 million people globally, with over 32 million in the U.S., leading to significant mobility loss and reduced quality of life [5] Company Overview - Artelo Biosciences is a clinical-stage pharmaceutical company focused on developing therapeutics that modulate lipid-signaling pathways for various conditions, including cancer, pain, and inflammation [7] - The company is advancing a portfolio of product candidates aimed at addressing unmet medical needs across multiple diseases [7] - ART26.12 is currently undergoing human trials, with initial clinical development targeting chemotherapy-induced peripheral neuropathy (CIPN) [6]

Core Insights - Artelo Biosciences, Inc. is focused on developing treatments for cancer, pain, and neuropsychiatric conditions through modulation of lipid-signaling pathways [1][5] - A recent publication highlights the therapeutic potential of Fatty Acid Binding Protein (FABP) inhibitors in treating mood and anxiety disorders, emphasizing the role of FABP5, FABP3, and FABP7 in neuroinflammatory signaling [2][3] Company Developments - Artelo's lead candidate, ART26.12, is a FABP5 inhibitor aimed at treating chemotherapy-induced peripheral neuropathy (CIPN) and is expected to report Phase 1 trial results in Q2 2025 [4] - The company has completed enrollment for a Phase 1 Single Ascending Dose study of ART26.12 with nearly 50 healthy volunteers, with data announcements anticipated this quarter [3][4] - Artelo's proprietary platform includes several backup and follow-on leads targeting FABP5 to elevate endogenous anandamide levels, which may provide anxiety-reducing and antidepressant effects without cognitive side effects [3][4] Research and Clinical Evidence - The peer-reviewed article co-authored by Doctor Steven Laviolette presents extensive preclinical evidence supporting the role of FABPs in the pathophysiology of anxiety and depression [2] - The findings suggest that inhibition of FABP5 can significantly elevate anandamide levels and modulate stress-related neurocircuits, indicating a promising avenue for neuropsychiatric treatment [3]

Drug Development - Artelo Biosciences is developing a dual cannabinoid agonist, ART27.13, for cancer-related anorexia, with Phase 1b enrollment completed in Q1 2023 and Phase 2a initiation in April 2023[91]. - The company received FDA clearance for ART26.12 in July 2024, with Phase 1 clinical trials for chemotherapy-induced peripheral neuropathy (CIPN) completed in April 2025[87][93]. - ART12.11, a proprietary cocrystal of CBD and TMP, is expected to have improved stability and bioavailability compared to non-cocrystal CBD compositions, with multiple potential indications being explored[94][95]. - Approximately 60% of advanced stage cancer patients are affected by cancer-related anorexia, highlighting the market need for ART27.13[90]. - ART26.12 has shown promising preclinical evidence in multiple pain models, prioritizing CIPN as the initial indication due to the lack of approved treatments[93]. - The company plans to develop ART12.11 for indications including PTSD, depression, epilepsy, and insomnia[95]. - The company has established a comprehensive approach to drug development, leveraging lipid signaling modulation pathways[86]. Intellectual Property - Artelo has secured two U.S. patents and multiple foreign patents for its CBD cocrystal composition, aiming for long-lasting market exclusivity[95]. Financial Performance - The company has not generated any revenue to date and may not do so in the near future[105]. - Total operating expenses for Q1 2025 were $2.4 million, a decrease of $0.2 million from $2.6 million in Q1 2024[108]. - The net loss for Q1 2025 was $2.4 million, compared to a net loss of $2.5 million in Q1 2024, reflecting a decrease of $0.1 million[108]. - Current assets decreased to $1.4 million as of March 31, 2025, from $2.6 million as of December 31, 2024[120]. - Current liabilities increased to $2.8 million as of March 31, 2025, from $1.8 million as of December 31, 2024[120]. - Cash used in operating activities for Q1 2025 was $1.6 million, down from $2.9 million in Q1 2024[122]. - The total working capital as of March 31, 2025, was negative $1.4 million, a decrease of $2.2 million from positive $0.8 million in 2024[119]. Capital and Funding - The company has issued a total of 425,344 shares under the Equity Line, generating aggregate proceeds of $679,000[111]. - The company filed a $75.0 million shelf registration statement effective for three years to provide flexibility for capital access[112]. - The company plans to pursue additional funding through equity or debt offerings to support ongoing operations[115]. Accounting and Reporting - Financial statements prepared in accordance with GAAP, requiring management estimates and assumptions[127]. - Actual results may differ from estimates due to inherent unpredictability and uncertainties[128]. - No new accounting standards adopted during the three months ended March 31, 2025[129]. - As a smaller reporting company, not required to provide detailed market risk disclosures[130]. - No off-balance sheet arrangements that materially affect financial condition or results of operations[126]. Management and Strategy - Artelo's management team has experience in developing and commercializing first-in-class therapeutics, with plans to retain rights for internal development[96]. - The company is actively pursuing collaborations in the biopharmaceutical industry to maximize shareholder value[96].