
Financial Performance - The company incurred a net loss of $13.7 million for the three months ended March 31, 2025, compared to a net loss of $18.5 million for the same period in 2024, representing a 26.5% improvement[20]. - The accumulated deficit as of March 31, 2025, was $395.4 million, up from $381.7 million at the end of 2024, indicating ongoing financial challenges[26]. - The net loss for the three months ended March 31, 2025, was $13.702 million, compared to a net loss of $18.504 million for the same period in 2024, indicating a 26.0% improvement[109]. - The company anticipates continued significant expenses and operating losses in the near term as it advances SL-325 and other product candidates[121][122]. - The company anticipates incurring additional net losses and negative cash flows from operations in the near future until significant sales of product candidates can be generated[144]. Revenue and Collaboration - The company reported collaboration revenue of $0 for Q1 2025, down from $1.1 million in Q1 2024, reflecting a significant decline in revenue generation[20]. - The Company derived all of its revenue in 2024 from collaborations with Ono Pharmaceutical Co., Ltd. and ImmunoGen, with all services required under these agreements completed by December 31, 2024[35]. - The Company recognized revenue of $5.4 million for preclinical research activities under the Ono Agreement for the three months ended March 31, 2024[88]. - The Company has not recognized any revenue from the ImmunoGen Agreement for the three months ended March 31, 2025[91]. - Collaboration revenue decreased by $1.1 million, or 100.0%, to $0.0 million for the three months ended March 31, 2025, due to the completion of obligations under previous agreements[124][138]. Research and Development - Research and development expenses decreased to $9.9 million in Q1 2025 from $16.3 million in Q1 2024, a reduction of 39.5%[20]. - Research and development expenses totaled $9.9 million for the three months ended March 31, 2025, down 39.0% from $16.3 million in the same period in 2024[121][137]. - Research and development costs are expensed as incurred, including salaries, stock-based compensation, and clinical trial expenses, reflecting the Company's ongoing investment in innovation[65]. - The Company is developing a first-in-class antibody for inflammatory bowel disease, with a focus on the SL-325 program targeting the TL1A/DR3 pathway[25]. - SL-325, the Company's lead program, is a high-affinity DR3 blocking monoclonal antibody aimed at treating inflammatory bowel disease (IBD)[111]. Cash and Liquidity - Cash and cash equivalents increased to $60.9 million as of March 31, 2025, up from $57.4 million at the end of 2024, marking a 4.4% increase[24]. - As of March 31, 2025, the company believes that cash and cash equivalents are sufficient to fund projected operations into 2027[146]. - The company has the ability to offer and sell up to $24.5 million of shares under the ATM Facility as of March 31, 2025[143]. - The company estimates that its existing cash and cash equivalents will fund operating expenses into 2027, but may require additional funding sooner than expected[170]. - Minimal cash was provided by financing activities during the three months ended March 31, 2025[151]. Economic and Market Conditions - The global macroeconomic environment remains uncertain, potentially impacting future operations[123]. - The United States imposed a 25% tariff on imports from Canada and Mexico, and a 10% additional tariff on imports from China, which may adversely affect global economic conditions[167]. - The Federal Reserve has raised interest rates multiple times, which may increase economic uncertainty and affect consumer spending[168]. - Increased inflation rates could adversely affect the company by increasing costs, including labor and employee benefit costs[168]. - The ongoing military conflicts and rising geopolitical tensions have created extreme volatility in global capital markets, potentially disrupting the global supply chain[168]. Operational Risks - The Company is highly dependent on a limited number of contract development and manufacturing organizations (CDMOs) for drug product supply, which poses a risk to its research and development activities[36]. - The ability to raise additional funds will depend on financial, economic, and market conditions, which may be beyond the company's control[171]. - The company may face delays or difficulties in initiating or expanding clinical trials and manufacturing sufficient quantities of materials due to macroeconomic conditions[169]. - The company is evaluating options related to the advancement of its mRNA/LNP administered multifunctional GLP-1 constructs and TRIM7 program, which may include independent financing[145]. Stock and Equity - The Company has 3,100,823 pre-funded warrants outstanding, which are included in the calculation of basic loss per share[72]. - The Company’s stock options outstanding increased from 6,468,859 as of March 31, 2024, to 8,458,834 as of March 31, 2025[73]. - The Company has 8,458,834 stock options outstanding as of March 31, 2025, with a weighted average exercise price of $5.52[100]. - The share reserve under the 2020 Equity Incentive Plan increased by 1,908,588 shares on January 1, 2025, with 3,721,751 shares available for future grants as of March 31, 2025[96].