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SOLANA BEACH, Calif., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic and neurological conditions, today reported its financial and operating results for the three months ended June 30, 2024 and provided a business update. “Artelo is entering an unprecedented phase of productivity in clinical development,” commented Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “Specifically, we look forward to multiple clinical readouts over the next 18 months across our portfolio. Most recently, we received clearance from the U.S. Food and Drug Administration (FDA) to initiate clinical trials for ART26.12 for the treatment of chemotherapy-induced peripheral neuropathy and Phase 1 trial results are expected during the first half of 2025. In addition, we anticipate full enrollment in the Phase 2a portion of the CAReS trial with our lead clinical asset, ART27.13, for the treatment of cancer-related anorexia near the end of 2024 or early 2025. To date, there have been no serious adverse events reported related to the study drug in CAReS. Finally, ART12.11, our proprietary cocrystal of CBD and TMP intended for the treatment of anxiety and depression, is in the final stages of product formulation as an oral solid, creating the potential to enter a clinical study early next year.” “With over $5.6 million of cash and cash equivalents as of June 30, 2024, and the receipt of approximately $1.3 million in cash from the UK government from R&D tax credits on July 10, 2024, we have the momentum to meaningfully advance our asset portfolio over the coming months,” concluded Mr. Gorgas. Other Company Highlights: Presented data from multiple preclinical studies at the 34th Annual International Cannabinoid Research Society Symposium Efficacy of ART26.12 in Breast Cancer-Induced Bone PainResults supporting broad potential utility of FABP Inhibitor platformMultiple studies confirming ART12.11’s potential advantages as a product candidate for the treatment of anxiety related disorders Presented highly encouraging data towards developing a solid dosage form of ART12.11, including comparative data to the Epidiolex formulation of CBD. Epidiolex had annual sales in excess of $700 million in 2023Announced publication of peer-reviewed article highlighting FABP7 as a promising novel target in cancer therapy Financial Results for Quarter Ended June 30, 2024 Cash and Investments: Cash and investments totaled $5.6 million as of June 30, 2024.R&D Expenses: Research and development expenses were $1.7 million for the three months ended June 30, 2024, compared to $0.8 million for the same period in 2023.G&A Expenses: General and administrative expenses were $0.8 million for the three months ended June 30, 2024, compared to $1.0 million for the same period in 2023.Net Loss: For the three months ended June 30, 2024, net loss was $2.4 million, or $0.75 per basic and diluted common share, which included $0.1 million of non-cash expenses, compared to a net loss of $1.6 million, or $0.56 per basic and diluted common share for the three months ended June 30, 2023, which included $0.2 million of non-cash expenses.R&D Tax Credit: Subsequent to the end of the quarter, the Company received approximately $1.3 million in cash on July 10, 2024, from the UK government related to qualified prior research and development expenses. About ART27.13ART27.13 is a G-Protein Coupled Receptor (GPCR) agonist, a highly potent, peripherally restricted new chemical entity, targeting CB1 and CB2 receptors, with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Originally developed by AstraZeneca plc, ART27.13 has been in clinical studies with over 250 subjects. A statistically significant and dose-dependent increase in body weight was observed in patients with back pain who were otherwise healthy. Importantly, the drug enables systemic metabolic effects while minimizing central nervous system-mediated toxicity. Having completed a Phase 1 study in cancer patients where ART27.13 demonstrated an excellent safety profile, Artelo is now advancing it in the CAReS trial as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Currently, there is no FDA-approved treatment for cancer anorexia cachexia syndrome. About CAReSThe Cancer Appetite Recovery Study (CAReS) is a Phase 1b/2a randomized, placebo-controlled trial of the Company’s lead clinical program, ART27.13, in patients with cancer anorexia and weight loss. Cancer-related anorexia, or the lack or loss of appetite in the person with cancer, may result from the cancer and/or its treatment with radiation or chemotherapy. It is common for people with cancer to lose weight. Anorexia and the resulting weight loss can affect a patient’s health, often weakening their immune system and causing discomfort and dehydration. A weight loss of more than 5% can predict a poor outcome for cancer patients and a lower response to chemotherapy. Now completed, the Phase 1b portion of the CAReS study was designed to determine the most effective and safest dose of ART27.13 for dosing in the Phase 2a stage. Currently enrolling, the Phase 2a portion of the CAReS study is designed to determine estimates of activity of ART27.13 in terms of lean body mass, weight gain, and improvement of anorexia. (ISRCTN registry: https://www.isrctn.com/ISRCTN15607817) About ART26.12Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids including endocannabinoids and fatty acids. FABP is overexpressed and associated with abnormal lipid signaling in a number of pathologies. ART26.12, Artelo’s lead FABP inhibitor cleared by FDA to initiate first-in-human studies, is a potent and selective inhibitor of FABP5 being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic, with an initial clinical study planned for chemotherapy-induced peripheral neuropathy (CIPN). Beyond ART26.12, Artelo’s extensive library of small molecule inhibitors of FABPs have shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, dermatologic conditions, and anxiety disorders. About ART12.11ART12.11 is Artelo’s wholly owned, proprietary cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP). Isolated as a single crystalline form, ART12.11 has exhibited better pharmacokinetics and improved efficacy compared to other forms of CBD in nonclinical studies. Superior pharmaceutical properties, including physicochemical, pharmacokinetic, and pharmacodynamic advantages have been observed with ART12.11. Artelo believes a more consistent and improved bioavailability profile may ultimately lead to increased safety and efficacy in humans, thus making ART12.11 a preferred CBD pharmaceutical composition. The US-issued composition of matter patent for ART12.11 is enforceable until December 10, 2038. About Artelo Biosciences Artelo Biosciences, Inc. is a clinical-stage pharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that modulate lipid-signaling pathways. Artelo is advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts, the Company applies leading-edge scientific, regulatory, and commercial discipline to develop high-impact therapies. More information is available at www.artelobio.com and Twitter: @ArteloBio. Forward Looking Statements This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission, including our ability to raise additional capital in the future. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by applicable securities laws. Investor Relations Contact:Crescendo Communications, LLCTel: 212-671-1020Email: ARTL@crescendo-ir.com

Primary and secondary objectives were met in the open-label randomized Part 1 of the clinical trial to treat uncomplicated UTIs caused by antibiotic-resistant E. coli Dosing has begun in Part 2, the controlled, double-blind portion of the trial triggered by the success in Part 1 Data support potential of Locus’ engineered bacteriophage platform in combatting the global health crisis of infections caused by multidrug-resistant (MDR) pathogens RESEARCH TRIANGLE PARK, N.C., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Locus Biosciences, Inc. (“Locus”), a clinical-stage biotechnology company developing a new class of precision engineered bacteriophage treatments for a diverse set of bacterial diseases, today announced positive results from Part 1 of its two-part Phase 2 ELIMINATE trial. This Phase 2 trial is evaluating LBP-EC01, a CRISPR-Cas3 genetically engineered bacteriophage therapy designed to treat patients with uncomplicated urinary tract infections (uUTIs) caused by antimicrobial-resistant (AMR) and multi-drug-resistant (MDR) Escherichia coli (E. coli). Data from the randomized, uncontrolled, open-label Part 1 portion of the trial were published in The Lancet Infectious Diseases. Locus also announced that dosing has begun in the randomized, controlled, and blinded Part 2 portion of this Phase 2 study. This clinical trial is supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Worldwide, an estimated 150 million people are affected by UTIs each year. Approximately 80% of these are caused by E. coli, often including difficult-to-treat strains that are resistant to commonly used antibiotics. Up to 40% of UTI patients experience a recurrence, often within months of the first episode. Both the U.S. Centers for Disease Control and Prevention and the World Health Organization have identified antibiotic-resistant E. coli as an urgent and serious public health threat requiring the development of new treatments. Part 1 of ELIMINATE enrolled 39 adult female patients, across six United States-based clinical centers and had an overall objective of defining a dosing regimen of LBP-EC01 and oral trimethoprim/sulfamethoxazole (TMP/SMX) to advance to Part 2 of the trial. This overall objective was supported by analysis of the primary outcome of pharmacokinetics (PK) in urine and blood, and the secondary outcome of safety, which were assessed on randomized patients dosed at least once with LBP-EC01. In addition, an exploratory outcome of pharmacodynamic (PD) assessments was performed on 16 evaluable patients. “The need for new targeted antibacterial therapies is urgent given the increasing impact of antibiotic-resistant pathogens, which we see in our clinic every day,” said Juvenal E. Martinez, M.D., an investigator in the trial. “As the first Phase 2 engineered bacteriophage trial, ELIMINATE is breaking new ground in the quest to address increasingly prevalent serious MDR infections. This encouraging initial data support the possible utility of bacteriophages and the potential of LBP-EC01 as a therapeutic option to address drug-resistant bacterial infections, such as UTIs, which have a high recurrence rate due to MDR pathogens.” ELIMINATE Trial Part 1 Results The primary and secondary outcomes of Part 1 were met, and a dosing regimen was identified that was well-tolerated and which led to high drug exposure at the site of infection. No serious adverse events were observed in Part 1, and exposure to LBP-EC01 did not lead to any observations of genetic resistance in any subsequently recovered E. coli samples. Part 1 was initiated with three treatment groups focused on intravenous (IV) delivery of a high 1×1011 plaque forming units (PFU)/dose of LBP-EC01 which was halted after three patients discontinued dosing due to non-serious adverse events of mild tachycardia and afebrile chills. Three updated treatment groups, which focused on a short, 3-day course of intra-urethral (i.e., IU or direct to bladder) and lower exposure IV dosing, replaced the original treatment groups. With this updated dosing approach, a rapid reduction of E. coli in urine was observed four hours after the first treatment which was maintained to the day 10 test of cure (TOC) evaluation. All (16 of 16) patients in the evaluable population had complete resolution of UTI symptoms and 14 of 16 (87.5%) patients demonstrated microbiologic cure or reduction of their bacterial infection below 1×103 colony forming units (CFU)/mL in urine by the day 10 TOC. A dosing regimen of LBP-EC01 given for 2 days IU (2×1012 PFU/dose) and given concurrently for 3 days IV (1×1010 PFU/dose) with concomitant oral TMP/SMX (160 mg TMP/800 mg SMX twice daily) has been advanced into Part 2. ELIMINATE Trial Part 2 underway Part 2 of the ELIMINATE trial has been initiated with patient dosing underway. This randomized, controlled, double-blind portion of the trial will evaluate the efficacy, safety, tolerability, and pharmacokinetics of LBP-EC01 with TMP/SMX. Up to 288 female uncomplicated UTI patients will be enrolled and randomized in a 1:1 ratio where patients will receive LBP-EC01 or placebo for the 3-day dosing regimen selected from Part 1. The primary objective will be to evaluate the effect of LBP-EC01 given with TMP/SMX on its ability to treat acute UTIs in patients with a history of UTI recurrence. The impact of the treatment on reducing UTI recurrence and/or extending the duration of time to the next UTI recurrence will be examined as an exploratory endpoint in a 6-month follow-up evaluation. This trial is registered with ClinicalTrials.gov, NCT05488340, and is ongoing. “These milestones represent a huge step forward in the critical fight against MDR. Over the past eight years, we have invested significant resources to build the Locus engineered bacteriophage platform. We developed our high-throughput robotics and AI technology to optimize a fixed set of precisely engineered phages that target over 95 percent of current uropathogenic E. coli strains, including MDR strains. We also built a world-class viral vector manufacturing facility that produces GMP materials at potency and purity levels higher than any others we have seen in the field to date. These Part 1 data validate our platform and support the advancement of a potential first-in-class therapy,” said Paul Garofolo, Co-founder and CEO of Locus. “We are grateful for the participating sites, clinicians, and patients, and our funding partner BARDA. We are eager to build on this positive momentum as we continue Part 2 of the ELIMINATE trial.” For more information on Part 1 of the ELIMINATE trial, visit clinicaltrials.gov using the identifier NCT05488340. Patients interested in participating in Part 2 can visit www.eliminateuti.com. About LBP-EC01LBP-EC01 is a CRISPR-enhanced bacteriophage therapy in development for the treatment of urinary tract infections and other infections caused by the pathogen E. coli. It is a bacteriophage cocktail engineered with a CRISPR-Cas3 construct targeting the E. coli genome. The precision medicine product works through a unique dual mechanism of action utilizing both the natural lytic activity of the bacteriophage along with the DNA-targeting activity of CRISPR-Cas3. LBP-EC01 previously met all primary and secondary endpoints and demonstrated safety and tolerability in a Phase 1b trial. LBP-EC01 is currently being evaluated in a Phase 2 trial for the treatment of UTIs caused by E. coli. In 2020, Locus and BARDA, part of the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), announced an agreement to co-fund development of LBP-EC01. Under the partnership agreement, contract number 75A50120C00169, BARDA will provide up to $93 million to Locus as part of a $152 million program to support Phase 2 and Phase 3 clinical trials and other activities required to seek marketing approval from the U.S. Food and Drug Administration (FDA) for LBP-EC01. About Locus BiosciencesLocus Biosciences is creating a new class of precision biotherapeutics with clinical-stage engineered bacteriophage treatments for a diverse set of bacterial and microbiome/inflammatory diseases. A world-leading bacteriophage discovery, synthetic biology, and manufacturing platform powers the company. Locus engineers bacteriophage - naturally occurring viruses that target bacteria - to kill pathogenic bacteria, while sparing good bacteria, through programmable precision anti-bacterials with CRISPR-Cas3 and other therapeutic payloads. Its artificial intelligence and machine-learning based discovery engine targets bacteria that are associated with disease across multiple therapeutic areas including infectious disease, immunology, and oncology. Locus has secured multiple non-dilutive partnerships to support development of the company’s platform and programs. These include anti-bacterial partnerships with Biomedical Advanced Research and Development Authority (BARDA) for its lead asset targeting E. coli and Combatting Antibiotic Resistant Bacteria Accelerator (CARB-X) for its asset targeting K. pneumoniae. For more on the Research Triangle Park, N.C.-based company, visit www.locus-bio.com. Media Contact:Gina Mangiaracina6 Degrees gmangiaracina@6degreespr.com