ASLAN Pharmaceuticals(ASLN) - 2023 Q4 - Annual Report

PART I Key Information The company faces principal investment risks from significant financial losses, going concern doubts, and heavy dependence on its two main product candidates Risk Factors The company faces significant financial and operational risks, including substantial net losses, going concern doubts, and dependence on its two main product candidates Financial Performance and Position | Metric | 2021 | 2022 | 2023 | | :--- | :--- | :--- | :--- | | Net Loss | $31.6M | $51.4M | $44.2M | | Accumulated Deficit (Year-End) | - | $278.4M | $321.1M | - The company's current liquidity and recurring losses raise substantial doubt about its ability to continue as a going concern, with cash and equivalents of approximately $21.3 million as of December 31, 2023[33] - The company's success is heavily dependent on its two main product candidates: eblasakimab for atopic dermatitis and farudodstat for alopecia areata[23][38] - On January 5, 2024, the company received a notice from Nasdaq for non-compliance with the $1.00 minimum bid price requirement and has until July 3, 2024, to regain compliance[206] Information on the Company ASLAN Pharmaceuticals is a clinical-stage immunology biopharmaceutical company focused on its lead candidates, eblasakimab for atopic dermatitis and farudodstat for alopecia areata History and Development of the Company Founded in 2010, the company is incorporated in the Cayman Islands with ADSs listed on the Nasdaq Capital Market under the symbol "ASLN" - ASLAN Pharmaceuticals Limited was incorporated in the Cayman Islands in June 2014, with its ADSs trading on Nasdaq under the symbol "ASLN"[253] - The company established a joint venture, JAGUAHR Therapeutics Pte. Ltd., with Bukwang Pharmaceutical Co., Ltd. to develop aryl hydrocarbon receptor (AhR) antagonists[255] Business Overview The company's business focuses on developing innovative treatments for immunological diseases, led by its pipeline candidates eblasakimab and farudodstat Product Candidate Pipeline | Product Candidate | Target | Indication | Stage of Development | | :--- | :--- | :--- | :--- | | Eblasakimab | IL-13Rα1 | Atopic Dermatitis (AD) | Phase 2b Completed | | | | Dupilumab-experienced AD | Phase 2 | | Farudodstat | DHODH | Alopecia Areata (AA) | Phase 2 | | AhR Antagonists | AhR | Immuno-oncology | Preclinical | - Eblasakimab (ASLAN004): A potential first-in-class monoclonal antibody targeting IL-13Rα1, with positive Phase 2b data supporting a potential monthly dosing regimen[257][258][262] - Farudodstat (ASLAN003): An oral DHODH inhibitor for autoimmune diseases, with a Phase 2 trial in Alopecia Areata (AA) expecting an interim readout in Q3 2024[259][264] - The company holds global rights for its product candidates, with specific regional licenses granted to partners in South Korea and Japan[261] Organizational Structure The Cayman Islands parent company fully owns subsidiaries in five countries and holds a 35% non-controlling interest in its associate, JAGUAHR Therapeutics - The parent company is ASLAN Pharmaceuticals Limited (Cayman Islands) with wholly-owned R&D subsidiaries in Singapore, Australia, Hong Kong, China, and the USA[431] - The company's shareholding in the joint venture JAGUAHR Therapeutics Pte. Ltd. was diluted to a 35% non-controlling interest in April 2021[431] Operating and Financial Review and Prospects The company reported its first revenue in 2023 but incurred a significant net loss driven by R&D expenses, raising substantial doubt about its going concern status Operating Results In 2023, the company generated its first revenue of $12.0 million but recorded a net loss of $44.2 million due to increased R&D and G&A expenses Consolidated Results of Operations (in thousands) | Metric | 2021 | 2022 | 2023 | | :--- | :--- | :--- | :--- | | Net Revenues | $0 | $0 | $12,000 | | R&D Expenses | $(22,021) | $(38,000) | $(42,495) | | G&A Expenses | $(11,825) | $(9,882) | $(13,240) | | Loss from Operations | $(33,846) | $(47,882) | $(43,736) | | Net Loss for the Year | $(31,590) | $(51,382) | $(44,220) | | Net Loss per ADS | $(2.40) | $(3.68) | $(2.69) | - Revenue of $12.0 million in 2023 was generated from an upfront payment under an out-licensing arrangement with Zenyaku Kogyo Co., Ltd[449][452][467] - Research and development expenses increased by $4.5 million (11.8%) YoY to $42.5 million in 2023, primarily due to costs for eblasakimab[471] - General and administrative expenses increased by $3.3 million (33.4%) YoY to $13.2 million in 2023, mainly due to higher employee-related and legal costs[469] Liquidity and Capital Resources With $21.3 million in cash, the company's resources are insufficient for the next 12 months, necessitating recent and future capital-raising activities Cash Flow Summary (in thousands) | Metric | 2021 | 2022 | 2023 | | :--- | :--- | :--- | :--- | | Net Cash Used in Operating Activities | $(33,995) | $(38,405) | $(46,639) | | Net Cash from Investing Activities | $(28) | $414 | $269 | | Net Cash from Financing Activities | $109,867 | $4,725 | $10,720 | | Net Change in Cash | $75,844 | $(33,266) | $(35,650) | - The company had cash and cash equivalents of $21.3 million as of December 31, 2023, which is not sufficient to cover planned expenditures for the next 12 months[477] - Recent financing includes a $20.0 million private placement in February 2023 and a $5.0 million registered direct offering in March 2024[439][437][478] - In December 2023, the company amended its loan with K2HV, making a $12.0 million prepayment and leaving $13.0 million of principal outstanding[487] Directors, Senior Management and Employees This section details the company's leadership, compensation structure, board practices, and employee base of 35 full-time staff as of year-end 2023 Directors and Senior Management The company is led by an experienced executive team and a board of non-executive directors chaired by Andrew Howden - The executive team includes Carl Firth, Ph.D. (CEO), Alexandre Kaoukhov (CMO), Stephen Doyle (CBO), Kiran Asarpota (COO and Head of Finance), and Ben Goodger (General Counsel)[503] - The non-executive directors are Andrew Howden (Chairman), Robert E. Hoffman, Neil Graham, M.D., and Kathleen M. Metters, Ph.D[503] Compensation In 2023, aggregate compensation was $5.5 million for executive officers and $280,417 for non-employee directors, utilizing equity-based awards Aggregate Compensation for FY 2023 | Group | Aggregate Compensation | | :--- | :--- | | Executive Officers | $5,512,479 | | Non-Employee Directors | $280,417 | - The company utilizes the 2020 Equity Incentive Plan (2020 EIP) for granting equity awards to employees, officers, and directors[520][541] Board Practices The Board comprises five members, four of whom are independent, and has four standing committees, adhering to Cayman Islands governance practices - The Board has four standing committees: Audit, Remuneration, Nomination, and Research and Development[553] - All directors, except for CEO Dr. Firth, are considered independent under Nasdaq rules, and the audit committee consists exclusively of independent members[548][554] - The company has adopted a Code of Business Conduct and Ethics applicable to all directors and employees[563] Employees As of December 31, 2023, the company had 35 full-time employees, with 17 in R&D and 18 in general and administrative roles across three countries - As of December 31, 2023, the company had 35 full-time employees: 17 in R&D and 18 in general and administrative functions[566] - The employees are located in Singapore (20), the United States (14), and the United Kingdom (1)[566] Major Shareholders and Related Party Transactions Entities affiliated with BVF Partners L.P. are the largest shareholder, and a key related party transaction was a $20.0 million private placement involving them Major Shareholders As of April 1, 2024, major shareholders include BVF Partners L.P. (9.99%) and Lind Global Fund II LP (5.52%), with management owning 5.91% Beneficial Ownership as of April 1, 2024 | Shareholder | Percentage of Ordinary Shares Beneficially Owned | | :--- | :--- | | Entities affiliated with BVF Partners L.P. | 9.99% | | Entities affiliated with Lind Global Fund II LP | 5.52% | | All current executive officers and directors as a group | 5.91% | Related Party Transactions The most significant recent related party transaction was a February 2023 private placement with BVF Partners L.P. that raised $20.0 million - On February 24, 2023, the company entered into a Unit Purchase Agreement with purchasers including entities affiliated with BVF Partners L.P., raising gross proceeds of approximately $20.0 million[577] Financial Information The company has never paid dividends, is restricted from doing so by a loan agreement, and is not currently party to any material legal proceedings - The company has never declared or paid a dividend and does not anticipate doing so, intending to retain earnings for business operations[586] - The K2HV loan agreement contains terms that prohibit or limit the amount of dividends that can be declared or paid[586] - The company is not currently a party to any legal proceedings that would have a material adverse effect on its business[589] Additional Information This section details the company's corporate structure, material contracts like the K2HV loan, and tax considerations, including its PFIC risk for U.S. holders Memorandum and Articles of Association As a Cayman Islands exempted company, its governance framework differs from U.S. corporate law regarding shareholder rights and director duties - The company is an exempted company incorporated under the Companies Act of the Cayman Islands, which provides certain governance advantages[606] - Holders of ordinary shares are entitled to one vote per share, and a special resolution requires a two-thirds majority vote[594] - Cayman Islands law provides for mergers and consolidations with procedures and dissenting shareholder rights that differ from those under Delaware law[622] Material Contracts Key contracts include an ATM offering agreement with Jefferies and a loan facility with K2 HealthVentures, which was recently amended - The company has an Open Market Sale Agreement with Jefferies LLC, allowing it to sell ADSs through at-the-market (ATM) offerings[634] - The loan agreement with K2 HealthVentures (K2HV) was amended in December 2023 to extend the principal repayment start date to January 1, 2025[636][638] Taxation The company is tax-exempt in the Cayman Islands but poses a risk of being classified as a Passive Foreign Investment Company (PFIC) for U.S. tax purposes - The company is incorporated in the Cayman Islands, which has no income, corporate, or capital gains tax[666][667] - There is a risk the company could be classified as a Passive Foreign Investment Company (PFIC); it believes it was not a PFIC in 2023 but was a PFIC in 2022[240][648] - If classified as a PFIC, U.S. Holders could face adverse tax consequences unless a mark-to-market or QEF election is made[649][652] Quantitative and Qualitative Disclosures about Market Risk The company is exposed to foreign currency exchange risk and interest rate risk, with a hypothetical 5% USD weakening increasing net loss by $0.58 million - The company is primarily exposed to foreign currency risk from assets and liabilities denominated in Singapore Dollars (SGD) and Australian Dollars (AUD)[674][675] - A hypothetical 5% weakening of the U.S. dollar against the Singapore dollar would result in a $0.58 million increase to net loss[678] - A hypothetical 100-basis point increase in interest rates would have increased the pre-tax loss for 2023 by approximately $265,989[679] Description of Securities Other than Equity Securities Each American Depositary Share (ADS), issued by JPMorgan, represents twenty-five ordinary shares and requires holders to act through the depositary - Each American Depositary Share (ADS) represents twenty-five ordinary shares of the company, with the depositary being JPMorgan Chase Bank, N.A[1][681] - ADS holders do not have direct shareholder rights and must exercise them, such as voting, through the depositary[683] - If an ADS holder does not provide timely voting instructions, the depositary may give a discretionary proxy to a person designated by the company[699] PART II Controls and Procedures Management concluded that the company's disclosure controls, procedures, and internal control over financial reporting were effective as of December 31, 2023 - Management, including the CEO and COO, concluded that as of December 31, 2023, the company's disclosure controls and procedures were effective[737] - Management assessed the internal control over financial reporting and concluded it was effective as of December 31, 2023, based on the COSO framework[739] - The company's independent registered public accounting firm issued an unqualified attestation report on management's assessment of internal control over financial reporting[740][773] Corporate Governance As a foreign private issuer, the company follows Cayman Islands governance practices, taking exemptions from certain Nasdaq corporate governance standards - As a foreign private issuer, the company follows home country (Cayman Islands) governance practices instead of certain Nasdaq corporate governance standards[748] - Specific exemptions include not being required to hold an annual general meeting and not needing shareholder approval for certain equity issuances[748][749] Cybersecurity The company manages cybersecurity risks through board oversight and processes like risk assessments and an incident response plan, relying on third-party providers - The company's cybersecurity risk management is overseen by the Board of Directors, with implementation managed by the CEO, General Counsel, COO, and IT Manager[758][759] - Cybersecurity processes include an incident response plan, risk assessments, access controls, and employee training, with assistance from third-party vendors[755][756] - As the company's IT services are cloud-based, it relies on third-party service providers for its infrastructure, introducing risks associated with their security practices[756] PART III Financial Statements This section contains the company's audited IFRS financial statements, which received an unqualified opinion with a "Going Concern" explanatory paragraph - The report includes audited consolidated financial statements for the three years ended December 31, 2023, prepared in conformity with IFRS[772] - The independent auditor's report from Deloitte & Touche LLP contains an unqualified opinion but includes a "Going Concern" paragraph, highlighting substantial doubt about its ability to continue[774][778]