Financial Performance - The company reported net losses of US$58.8 million, US$109.2 million (revised), and US$51.9 million for the years ended December 31, 2022, 2023, and 2024, respectively [625]. - The total operating loss for the years ended December 31, 2022, 2023, and 2024 was US$67.3 million, US$72.6 million, and US$52.5 million, respectively [647]. - The company has not generated any revenue from product sales to date, with no revenue reported for the years 2023 and 2024 [629][649]. - Loss for the period decreased from US$109.2 million in 2023 to US$51.9 million in 2024 [654]. Research and Development - Research and development expenses increased from US$54.5 million in 2022 to US$58.2 million in 2023, and decreased to US$44.9 million in 2024 [648]. - AN2025, the lead product, is undergoing a Phase III clinical trial across more than 180 sites in 18 jurisdictions, with patient enrollment completed in November 2023 [623]. - The company plans to submit IND filings for AN8025 and AN9025 in mid-2025 and the second half of 2025, respectively [623]. - Research and development expenses decreased by 22.8%, from US$58.2 million in 2023 to US$44.9 million in 2024, primarily due to a decrease in CRO service fees and payroll expenses [651]. Financial Position and Cash Flow - As of December 31, 2024, the company had US$60.9 million in cash and cash equivalents [662]. - Net cash used in operating activities was US$51.8 million in 2024, compared to US$56.7 million in 2023 [665]. - Net cash from investing activities was US$28.1 million in 2024, primarily due to recovery of investments at amortized cost [668]. - Net cash from financing activities was US$116.2 million in 2023, primarily due to the completion of the initial public offering [670]. Administrative and Other Expenses - The company anticipates increased administrative expenses to support ongoing research and development activities and compliance with public company requirements [631]. - Administrative expenses decreased by 34.9%, from US$15.3 million in 2023 to US$10.0 million in 2024 [650]. - Other income and gains decreased by 7.7%, from US$3.3 million in 2023 to US$3.0 million in 2024 [652]. Financial Liabilities and Risks - Fair value loss on financial liabilities at FVTPL decreased from US$39.2 million in 2023 to US$0 in 2024 [653]. - The fair value of financial liabilities, including convertible loans and warrants, is measured at FVTPL using valuation techniques such as discounted cash flow [688]. - The company is exposed to foreign currency risk due to income and expenditures in both U.S. dollars and Renminbi, with plans to fund expenditures in China using Renminbi [809]. - A 10% depreciation of the Renminbi against the U.S. dollar would result in a decrease of $4.3 million, or 7.1%, in cash and cash equivalents as of December 31, 2024 [810]. Accounting Policies - The company prepares its consolidated financial statements in accordance with IFRS, requiring estimates and assumptions that may differ from actual results [683]. - Research and development costs are expensed as incurred, while product development expenditures are capitalized only when technical feasibility is demonstrated [684]. - Impairment assessments for non-financial assets are conducted at the end of each relevant period, with calculations based on fair value less costs of disposal or value in use [691]. - Deferred tax assets are recognized for unused tax losses, requiring significant management judgment regarding future taxable profits [692]. - The incremental borrowing rate is estimated for lease liabilities when the interest rate implicit in a lease cannot be readily determined [693]. Capital Expenditures - Capital expenditures were US$1.2 million, US$0.2 million, and US$0.2 million in 2022, 2023, and 2024, respectively [675]. Liquidity Management - The company monitors liquidity to maintain adequate cash and cash equivalents for operations and to mitigate cash flow fluctuations [811]. Share-Based Payments - Share-based payments are recognized in employee benefit expense, reflecting the fair value at the grant date determined by an external valuer [686].

Core Insights - Adlai Nortye Ltd. is set to present two abstracts at the upcoming American Association for Cancer Research (AACR) Annual Meeting from April 25-30, 2025, in Chicago, showcasing its innovative cancer therapies [1][2]. Group 1: Presentation Details - The first poster presentation is titled "Coordinated stimulation of APC and T cell functions by first-in-class, tri-specific AN8025 for next-generation cancer immunotherapy," scheduled for April 28, 2025 [3]. - The second poster presentation is titled "AN9025, an orally bioavailable pan-RAS(ON) inhibitor with potent, broad-spectrum anti-tumor activity," scheduled for April 29, 2025 [3]. Group 2: Product Information - AN8025 is a proprietary tri-specific antibody fusion protein designed to enhance T cell and antigen-presenting cell functions, with preclinical studies showing robust anti-tumor efficacy [4]. - AN9025 is an oral small molecule pan-RAS(ON) inhibitor targeting a broad spectrum of RAS mutations, demonstrating potent efficacy against various cancers, including pancreatic, lung, and colorectal adenocarcinomas [5]. Group 3: Company Overview - Adlai Nortye is a global clinical-stage biotechnology company focused on developing innovative cancer therapies, with R&D centers in the U.S. and China [6]. - The company is advancing a robust oncology pipeline, including its lead candidate Buparlisib (AN2025), currently in a Phase 3 trial for recurrent or metastatic head and neck squamous cell cancer [6].

Core Viewpoint - Adlai Nortye Ltd. (ANL) has experienced significant selling pressure, resulting in a 33.1% decline over the past four weeks, but analysts anticipate improved earnings ahead, indicating potential for recovery [1]. Group 1: Stock Performance - ANL's stock has lost 33.1% in the last four weeks, indicating a substantial decline [1]. - The stock is currently in oversold territory, with an RSI reading of 28.1, suggesting that the heavy selling may be exhausting itself [3]. Group 2: Analyst Expectations - Analysts have raised earnings estimates for ANL by 32.6% over the past 30 days, indicating a positive shift in expectations [4]. - ANL holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [4].

Core Viewpoint - Adlai Nortye Ltd. is set to present promising preliminary data on its drug AN0025 in combination with definitive chemoradiotherapy for treating unresectable locally advanced or locally recurrent esophageal cancer at the ASCO Annual Meeting in Chicago from May 31 to June 4, 2024 [1][3]. Company Overview - Adlai Nortye Ltd. is a clinical-stage biotechnology company focused on developing innovative cancer therapies, with R&D centers in New Jersey, US, and Hangzhou, China [4]. - The company has a robust pipeline of six drug candidates aimed at addressing various tumor types [4]. - Adlai Nortye aims to become a global leader in oncology therapies through a combination therapy strategy, with the goal of transforming deadly cancers into chronic and eventually curable diseases [5]. Clinical Study Details - AN0025 is a selective EP4 inhibitor that modulates macrophages and immunosuppressive myeloid cells in the tumor microenvironment, showing antitumor activity [2]. - The AN0025S0104 study is a Phase Ib clinical trial designed to evaluate the safety, tolerability, and feasibility of AN0025 combined with definitive chemoradiotherapy for esophageal cancer [2]. - The study is a single-arm, open-label, multicenter trial that includes a dose escalation phase followed by an expansion phase [2]. Upcoming Presentation - The abstract for the ASCO presentation is titled "AN0025 in combination with definitive chemoradiotherapy (dCRT) in unresectable locally advanced or locally recurrent esophageal cancer (EC): a single-arm, open-label, multicenter, Phase Ib study (AN0025S0104)" [3]. - The first author of the abstract is Nan Bi from the Department of Radiation Oncology, National Cancer Center, Chinese Academy of Medical Sciences [3].

Core Insights - Adlai Nortye Ltd. is set to present promising preliminary data on its drug AN0025 in combination with definitive chemoradiotherapy for treating unresectable locally advanced or locally recurrent esophageal cancer at the ASCO Annual Meeting in Chicago from May 31 to June 4, 2024 [1][3] Company Overview - Adlai Nortye is a clinical-stage biotechnology company focused on developing innovative cancer therapies, with R&D centers in New Jersey, US, and Hangzhou, China [4] - The company has a robust pipeline of six drug candidates aimed at addressing various tumor types [4] - Adlai Nortye aims to become a global leader in oncology therapies through a combination therapy strategy, with the goal of transforming deadly cancers into chronic and eventually curable diseases [5] Clinical Study Details - AN0025 is a selective EP4 inhibitor that modulates macrophages and immunosuppressive myeloid cells in the tumor microenvironment, showing synergistic antitumor efficacy when combined with chemoradiotherapy in previous trials [2] - The ongoing AN0025S0104 study is a Phase Ib, single-arm, open-label, multicenter trial evaluating the safety and feasibility of AN0025 plus definitive chemoradiotherapy for esophageal cancer [2][3] Strategic Partnerships - The company has established a global management team and scientific advisory board to guide its R&D and business development efforts [5] - Adlai Nortye is actively seeking partnerships with leading pharmaceutical companies like Eisai and Novartis to enhance the potential of its pipeline programs [5]

Core Insights - Adlai Nortye Ltd. has initiated the Phase II clinical trial ARTEMIS to evaluate the efficacy of palupiprant (AN0025) in combination with chemoradiotherapy for treating rectal cancer [1][2][3] Company Overview - Adlai Nortye is a clinical-stage biotechnology company focused on developing innovative cancer therapies, with R&D centers in New Jersey, US, and Hangzhou, China [5] - The company has a robust pipeline of six drug candidates and aims to transform cancer into a chronic and eventually curable disease through combination therapy strategies [6] Clinical Trial Details - The ARTEMIS study is a randomized, multi-center, open-label trial involving 140 patients with moderate to high-risk rectal cancer, comparing total neoadjuvant therapy (TNT) with and without AN0025 [2][3] - The primary endpoint of the study is the clinical complete response (cCR) rate at six months post-radiotherapy [2] Drug Information - Palupiprant (AN0025) is a small molecule EP4 antagonist designed to modulate the tumor microenvironment, currently under development for locally advanced rectal cancer [4] - Previous Phase 1b results indicated that the combination therapy with AN0025 and radiotherapy/chemoradiotherapy was safe and resulted in a 36% cCR or pathologic complete response (pCR) rate [4]

Core Insights - Adlai Nortye Ltd. has initiated the Phase II clinical trial ARTEMIS to evaluate the efficacy of palupiprant (AN0025) in combination with chemoradiotherapy for treating rectal cancer [1][2][3] Company Overview - Adlai Nortye is a clinical-stage biotechnology company focused on developing innovative cancer therapies, with R&D centers in New Jersey, US, and Hangzhou, China [5] - The company has a robust pipeline of six drug candidates and aims to transform cancer into a chronic and eventually curable disease [6] Clinical Trial Details - The ARTEMIS study is a randomized, multi-center, open-label trial involving 140 patients with moderate to high-risk rectal cancer, comparing total neoadjuvant therapy (TNT) with and without AN0025 [2] - The primary endpoint of the study is the clinical complete response (cCR) rate at six months post-radiotherapy [2] Drug Information - Palupiprant (AN0025) is a small molecule EP4 antagonist designed to modulate the tumor microenvironment, currently under development for locally advanced rectal cancer [4] - Previous Phase 1b results indicated that 36% of patients achieved either a cCR or pathologic complete response (pCR) when treated with AN0025 in combination with radiotherapy [4]

Group 1 - Adlai Nortye Ltd. Sponsored ADR (ANL) has returned 44.6% year-to-date, significantly outperforming the Medical sector average of 4.3% [2] - The Zacks Rank for ANL is 2 (Buy), indicating a positive earnings outlook with a 3.6% increase in the consensus estimate for full-year earnings over the past quarter [2] - ANL belongs to the Medical - Biomedical and Genetics industry, which has an average loss of 3.4% year-to-date, further highlighting ANL's strong performance [3] Group 2 - Boston Scientific (BSX) is another Medical stock that has outperformed the sector, with a year-to-date increase of 27.1% [3] - The Zacks Rank for Boston Scientific is also 2 (Buy), with a 3.1% increase in the consensus estimate for current year EPS over the past three months [3] - The Medical - Products industry, to which Boston Scientific belongs, has returned +3.3% year-to-date, ranking 145 in the Zacks Industry Rank [3]

Group 1 - Adlai Nortye Ltd. Sponsored ADR (ANL) is currently outperforming its Medical sector peers with a year-to-date gain of approximately 50.7%, while the average gain for Medical stocks is only 1.2% [2][3] - The Zacks Consensus Estimate for ANL's full-year earnings has increased by 3.6% over the past three months, indicating improving analyst sentiment and a positive earnings outlook [2] - ANL holds a Zacks Rank of 2 (Buy), suggesting it is positioned to outperform the broader market in the near term [1][2] Group 2 - Adlai Nortye Ltd. is part of the Medical - Biomedical and Genetics industry, which has seen an average loss of 7.9% this year, further highlighting ANL's strong performance within its specific industry [3] - Elevance Health (ELV) is another Medical stock that has outperformed its sector, with a year-to-date increase of 13.2% and a Zacks Rank of 2 (Buy) [2][3] - The Medical Services industry, to which Elevance Health belongs, is currently ranked 80 and has gained 5% this year [3]

Financial Contributions and Dividends - Capital contributions from Adlai Nortye Ltd. to Adlai Nortye USA Inc. increased from $18,670 thousand in 2021 to $32,369 thousand in 2023[23]. - Intercompany loans from Adlai Nortye Ltd. to Adlai Nortye (HK) Limited decreased from $46,794 thousand in 2021 to $8,350 thousand in 2023[23]. - Adlai Nortye Ltd. has not declared or paid any dividends to its shareholders as of the date of the report[20]. - The ability of Adlai Nortye's PRC subsidiaries to distribute dividends is limited by foreign exchange restrictions under PRC law[21]. - A withholding tax rate of up to 10% may apply to dividends payable by Chinese companies to non-PRC-resident enterprises[21]. - Capital contributions from Adlai Nortye (HK) Limited to its mainland China subsidiaries decreased from $33,960 thousand in 2021 to $10,826 thousand in 2023[23]. - The company may depend on receipt of funds from its subsidiaries to pay cash dividends in the future[20]. - The company may rely on dividends from its PRC subsidiaries to fund cash requirements, and limitations on these payments could adversely affect operations[32]. Regulatory and Compliance Risks - The PCAOB determined in December 2021 that it could not fully inspect registered public accounting firms in mainland China and Hong Kong, impacting the company's auditor[24]. - The Consolidated Appropriations Act, signed into law on December 29, 2022, reduced the number of consecutive non-inspection years from three to two under the HFCAA[24]. - The company has substantial operations in mainland China and is subject to evolving PRC laws and regulations, which may impact its ability to accept foreign investments and list on U.S. exchanges[25]. - The company is required to make milestone payments under licensing agreements, which may pose financial challenges if development timelines are not met[62]. - The company’s clinical trials are subject to oversight by regulatory authorities, and any non-compliance could lead to suspensions or terminations[45]. - Compliance with good clinical practice (GCP) and regulatory requirements is critical; failure to comply may result in unreliable clinical data and delays in regulatory approvals[70]. - The company must comply with stringent privacy laws and data protection regulations, which are evolving and may increase compliance costs[169]. Financial Performance and Losses - The company has incurred net losses and anticipates continuing to do so for the foreseeable future, relying on the success of its preclinical and clinical drug candidates[27]. - The net loss for the company was $56.7 million, $58.8 million, and $104.9 million for the years ended December 31, 2021, 2022, and 2023, respectively[198]. - The company anticipates significant commercialization expenses if regulatory approvals for drug candidates are obtained, necessitating substantial additional funding[204]. - The company expects ongoing net cash outflows from operating activities and may require additional cash resources in the future[203]. - The company had accumulated deficits as of December 31 for the years 2021, 2022, and 2023, indicating potential liquidity risks[205]. - Financial assets at fair value through profit or loss (FVTPL) decreased from US$53.8 million in 2021 to US$7.0 thousand in 2023[206]. - Share-based payment expenses were US$4.3 million in 2023, down from US$6.1 million in 2022 and up from US$3.4 million in 2021[207]. Research and Development - Research and development expenses for the years ended December 31 were US$42.1 million, US$54.5 million, and US$58.2 million for 2021, 2022, and 2023 respectively[44]. - The company is conducting preclinical studies and clinical trials for existing and new drug candidates, which may take multiple years to develop[201]. - The company may need to conduct additional clinical trials or testing, which could delay regulatory approvals or limit the scope of approved indications[49]. - The company may face increased costs for clinical trials due to unexpected delays and regulatory issues, which could impact commercialization timelines[50]. - The company may seek additional fast track designations for other drug candidates to address unmet medical needs[182]. Intellectual Property Risks - The company relies on third-party licensors for intellectual property rights, which may limit its ability to develop or commercialize certain drug candidates[56]. - Intellectual property rights could be challenged or invalidated, leading to potential loss of valuable patents or narrowing of patent claims[79]. - The outcome of patent litigation is unpredictable, and adverse results could lead to invalidation or narrow interpretation of patents, affecting the company's ability to protect its drug candidates[88]. - The company faces uncertainties regarding the scope and protection of its patents, which may be interpreted narrowly by courts, potentially diminishing their value[90]. - The company cannot guarantee that it or its licensors were the first to file on the inventions claimed in its patents, which may affect patent issuance[92]. - Compliance with patent administration authorities is crucial; failure to meet requirements could result in reduced or eliminated patent protection[95]. Market and Competitive Risks - The company may face significant competition from other pharmaceutical or biotechnology companies, which could hinder the establishment of strategic partnerships[66]. - The company faces intense competition from larger pharmaceutical and biotechnology companies, which may have more resources and faster regulatory approval processes[152]. - Future approved drug candidates may struggle to gain market acceptance due to competition, pricing, and reimbursement issues[148]. - The company may encounter delays in clinical trials or commercialization due to manufacturing problems, which could increase costs and impact revenue generation[141]. - The illegal importation of competing products and counterfeit pharmaceuticals may adversely affect demand for future approved drug candidates[163][164]. Manufacturing and Supply Chain Risks - The company relies on third-party contract manufacturers (CMOs) for the production of drug candidates, which poses risks related to compliance with regulatory requirements and quality control[135]. - Manufacturing biopharmaceutical products is complex, and the company may face challenges such as equipment malfunctions and supply chain issues that could impact production[139]. - The company is dependent on third-party suppliers for raw materials, which may lead to delays or increased costs if supply issues arise[147]. - The company may need to scale up production significantly to meet anticipated market demand, which could be challenging if contract manufacturers cannot meet quantity requirements[146]. Strategic Initiatives - The company may seek strategic alliances or collaborations for drug development, which could involve relinquishing some control over drug candidates[51]. - The company currently has no sales, marketing, or commercial product distribution capabilities and plans to develop an in-house marketing organization, which will require significant capital expenditures and management resources[155]. - The company intends to operate in 18 significant markets across North America, Europe, and Asia, facing complex regulatory compliance burdens[166].