Equillium(US:EQ)2025-05-14 20:10Financial Position - As of March 31, 2025, the company had $14.5 million in cash and cash equivalents, with an accumulated deficit of $202.5 million[91][100]. - The accumulated deficit as of March 31, 2025, was $202.5 million, indicating ongoing financial challenges[136]. - The company believes its cash and cash equivalents can fund operations into the third quarter of 2025, but there is substantial doubt about its ability to continue as a going concern[129]. - The company will need to raise additional capital to fund operations beyond the third quarter of 2025, with uncertainty regarding the ability to secure such funding[130]. - The company has no material non-cancelable purchase commitments with service providers, indicating flexibility in cash management[135]. - The company has experienced extreme volatility in financial markets, impacting liquidity and credit availability, which may affect future financing efforts[134]. Revenue and Expenses - The company has not generated any revenues from product sales, with past revenues derived from an upfront payment of $26.4 million under the Asset Purchase Agreement with Ono[104][105]. - Revenue for the three months ended March 31, 2025, was $0, a decrease of $10.7 million compared to $10.7 million in the same period of 2024[118]. - Research and development expenses primarily consist of costs associated with non-clinical research and clinical development of product candidates[108]. - Research and development expenses decreased to $5.9 million for the three months ended March 31, 2025, down from $9.7 million in 2024, a reduction of $3.8 million[120]. - General and administrative expenses were $2.9 million for the three months ended March 31, 2025, compared to $3.7 million in 2024, a decrease of $0.8 million[122]. - Interest income decreased to $0.2 million for the three months ended March 31, 2025, from $0.4 million in 2024, a decline of $0.2 million[123]. - Other income was $43,000 for the three months ended March 31, 2025, compared to an expense of $0.4 million in 2024, reflecting a change of $0.4 million[124]. - Cash used in operating activities was $8.2 million for the three months ended March 31, 2025, a decrease from $8.8 million in the prior year[137]. - The company expects to continue incurring operating losses and negative cash flows for at least the next several years due to ongoing development costs[136]. Clinical Development - The company plans to initiate a first-in-human Phase 1 clinical study for EQ504 in the first quarter of 2026, pending additional capital[92]. - Itolizumab (EQ001) did not meet primary outcomes in the Phase 3 EQUATOR study for acute graft-versus-host disease, but showed clinically meaningful improvements in durable complete response from Day 29 to 99[94][95]. - The company submitted data from the EQUATOR study to the FDA for Breakthrough Therapy Designation, but the FDA declined to grant it based on the current data[96]. - EQ302, a preclinical-stage product candidate, is on hold due to financial constraints, with plans to resume development contingent on securing additional funding[98]. - The company anticipates significant increases in expenses as it resumes development activities for EQ504, itolizumab (EQ001), and EQ302, contingent on raising additional capital[127]. - The company paused research and development activities pending the ability to raise capital in the second quarter of 2025, with potential strategic alternatives including mergers[91][102]. Capital Raising Activities - The company entered into a 2023 ATM Facility allowing for the sale of up to $21.95 million in common stock, with gross proceeds of approximately $55,000 from 109,410 shares sold during the three months ended March 31, 2025[126]. - The company raised approximately $53,000 from the sale of shares under the 2023 ATM Facility during the three months ended March 31, 2025[139]. - The company has contingent consideration liabilities related to potential milestone payments under various agreements, but these are considered unlikely to come due within the next 12 months[141].