Artelo Biosciences Reports Fiscal 2023 Year-End Financial Results and Provides Business Update
- Completion of phase 1b and initiation of phase 2a of CAReS with ART27.13.
- Advancement of ART 26.12 towards IND submission for neuropathic pain.
- Data presentation on the efficacy of ART12.11 in anxiety and depression models.
- Safety results and research findings on ART27.13's protective properties.
- Positive effects of ART26.12 in neuropathic pain models.
- Strengthening of patent estate with 52 issued patents and 37 pending applications.
- Cash and investments totaling $10.4 million by the end of 2023.
- R&D expenses of $5.7 million and a net loss of $9.3 million for 2023.
- None.
Insights
Reviewing Artelo Biosciences' fiscal year-end financial results reveals a strategic allocation of capital towards research and development (R&D), which is a positive indicator for a pharmaceutical company heavily invested in clinical trials. The increase in R&D expenses from $4.3 million to $5.7 million year-over-year suggests a commitment to advancing their product pipeline, particularly ART27.13 and ART26.12. This is a common trend for companies in this stage of development, as investment in R&D can lead to significant future revenue streams if the drugs prove successful.
Furthermore, the reduction in general and administrative (G&A) expenses from $6.0 million to $4.2 million indicates improved operational efficiency or a strategic shift to prioritize R&D over other expenditures. This is often viewed favorably by investors as it may signal management's confidence in the company's core scientific projects. However, the reported net loss of $9.3 million, with a reduction from the previous year's $10.1 million, reflects the typical financial position of a clinical-stage biopharmaceutical company, where profitability is not expected until drug approval and commercialization. The cash position of $10.4 million, projected to support operations into the second half of 2025, provides a short-term financial runway, but further capital may be needed to reach commercialization.
The transition of the Cancer Appetite Recovery Study (CAReS) with ART27.13 from phase 1b to phase 2a is a significant milestone, as it moves the drug closer to potential market approval. The study's focus on lean body mass, weight gain and anorexia in cancer patients addresses an unmet need in oncology supportive care, which could lead to a substantial market opportunity if the drug is approved. The absence of grade 3 or 4 adverse events reported at the Cancer Cachexia Society annual conference is a positive safety signal, which is important for patient acceptance and regulatory approval.
Preclinical research demonstrating ART26.12's positive effects in neuropathic pain models, including prevention of Oxaliplatin-induced peripheral neuropathy, suggests potential for addressing another significant unmet medical need. The protective properties of ART27.13 against muscle degeneration caused by cancer, as published in Pharmaceuticals, further underlines the therapeutic potential of Artelo's pipeline.
Given the complexity of drug development, the strengthened patent estate, with 52 issued patents and 37 pending applications, provides a layer of protection against competition and is an important asset for the company's valuation. The implications for stakeholders include the potential for partnerships, licensing deals, or acquisition interest as Artelo progresses through clinical trials.
Artelo Biosciences' strategic focus on modulating lipid-signaling pathways taps into a niche but growing segment within the pharmaceutical industry. The company's progress in clinical trials and patent acquisitions positions it well within the competitive landscape. The market for cancer supportive care and neuropathic pain treatment is substantial and Artelo's advancements in these areas could capture significant market share if their drugs are successful.
From a market perspective, the positive pre-IND meeting outcomes and the anticipated IND submission for ART26.12 are key indicators of the company's trajectory and could serve as catalysts for stock valuation. The projected cash runway into the second half of 2025 suggests that Artelo may avoid immediate dilutive financing, which is often a concern for investors in biotech companies. However, the long-term financial strategy will likely need to address further funding for late-stage trials and potential commercialization efforts.
Major achievements in 2023 lay the foundation for key upcoming milestones
SOLANA BEACH, Calif., March 25, 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 financial and operating results for the fiscal year ended December 31, 2023 and provided a business update.
Key Program Accomplishments in 2023:
- Completed phase 1b and initiated phase 2a of the Cancer Appetite Recovery Study (CAReS) with ART27.13;
- Advanced ART 26.12 toward IND submission in 2024 for the treatment of painful neuropathies following positive pre-IND meeting with the FDA; and
- Presented data demonstrating improved efficacy and bioavailability of ART12.11 compared to cannabidiol in well-established models of anxiety and depression.
“We made substantial progress on multiple programs last year,” commented Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “Notably, CAReS progressed from the dose-ranging phase 1b to the randomized phase 2a where we will assess the safety and efficacy of ART27.13 in terms of lean body mass, weight gain, activity, and improvement of anorexia versus placebo. Importantly, with ART27.13 now being studied in approximately a dozen clinical sites in five countries, we are on track to fully enroll the phase 2a of CAReS before the end of 2024.”
“Additionally, following the positive pre-IND meeting held with the FDA and five preclinical animal studies in painful neuropathies, we completed the critical toxicology studies and important manufacturing steps with ART26.12 necessary for an IND filing in the first half of this year. The momentum from last year and our cash, projected to support operations into the second half 2025, give us confidence in achieving several important clinical milestones that hold the potential to drive significant value for shareholders,” stated Gorgas.
Additional Recent Business Highlights:
- Presented safety results for ART27.13 from the 1b phase of CAReS at the Cancer Cachexia Society annual conference by leading investigator, Dr. Barry Laird, where it was noted there were no grade 3 or 4 adverse events related to ART27.13 in the cancer population.
- Published peer-reviewed research in the journal, Pharmaceuticals, demonstrated protective properties of ART27.13 against muscle degeneration caused by cancer. This data suggests the dual mechanism of ART27.13 is relevant for both the anorexia and the cachexia associated with advanced stage cancer.
- Announced pre-clinical research demonstrating ART26.12’s positive effects in multiple models of neuropathic pain, as well as effectiveness in treating and preventing Oxaliplatin-induced peripheral neuropathy.
- Strengthened patent estate across the entire portfolio with a new total of 52 issued patents and 37 pending applications in US and foreign territories.
Fiscal 2023 Year-End Financial Results
- Cash and Investments: Cash and investments totalled
$10.4 million as of December 31, 2023. - R&D Expenses: Research and development expenses were
$5.7 million for the year ended December 31, 2023, compared to$4.3 million for the same period in 2022. - G&A Expenses: General and administrative expenses were
$4.2 million for the year ended December 31, 2023, compared to$6.0 million for the same period in 2022. - Net Loss: For the year ended December 31, 2023, net loss was
$9.3 million , or$3.14 per basic and diluted common share, which included$0.4 million of non-cash expenses, compared to a net loss of$10.1 million , or$3.56 per basic and diluted common share for the year ended December 31, 2022, which included$2.3 million of non-cash expenses.
About ART27.13
ART27.13 is a G-Protein Coupled Receptor (GPCR) agonist, a highly potent, peripherally restricted new chemical entity, targeting CB1and 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 CAReS
The 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
About ART26.12
Fatty 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, 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, and anxiety disorders.
About ART12.11
ART12.11 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 including the endocannabinoid system. 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, 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, LLC
Tel: 212-671-1020
Email: ARTL@crescendo-ir.com
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