IN8bio(US:INAB)2025-05-07 20:03Clinical Trials and Product Development - The company has conducted two Phase 1 clinical trials for gamma-delta T cell technologies, demonstrating long-term durable remissions with patients remaining alive and in remission for over three years[95]. - INB-100 showed a 100% complete remission rate in acute myeloid leukemia patients with a median follow-up of 20.1 months, exceeding real-world control groups[96]. - INB-200 demonstrated a 79% increase in median progression-free survival (12.4 months) compared to the standard-of-care regimen (6.9 months)[98]. - INB-600, a new T cell engager platform, has shown potential for sustained anti-tumor responses and minimal risk of cytokine release syndrome[100]. - The company has a portfolio of preclinical programs, including INB-300 and INB-500, aimed at advancing cellular manufacturing for allogeneic therapies[103]. - The company is actively seeking collaborative partners for its product candidates, including INB-400[125]. Financial Position and Funding - The company has $11.9 million in cash as of March 31, 2025, which is not anticipated to fund operations for the next 12 months, raising concerns about its ability to continue as a going concern[107]. - The company expects to incur additional losses as it advances product candidates through clinical trials and seeks to expand its portfolio[107]. - In April 2025, the company raised $1.9 million through the exercise of Series A and Series B warrants, resulting in the issuance of 9,321,081 shares of common stock[110]. - The company has not generated any revenue since inception and does not expect to do so in the foreseeable future[112]. - The company is seeking alternative funding sources and strategic partnerships to support the development of its product candidates[99]. - The company plans to seek additional capital through equity and/or debt offerings to support ongoing operations and product development[125]. - The company raised an aggregate of $135.9 million from the sale of securities through March 31, 2025[124]. - The company sold 7,362,852 shares under the ATM program during the three months ended March 31, 2025, resulting in net proceeds of approximately $3.7 million[132]. - Cash used in operating activities was $3.1 million for the three months ended March 31, 2025, primarily due to a net loss of $5.6 million[143]. - Cash provided by financing activities was $3.9 million during the three months ended March 31, 2025, mainly from $3.7 million in net proceeds from the ATM program[147]. - The company expects to continue financing operations through additional equity or debt financings, which may result in dilution to existing stockholders[138]. - The company had no long-term debt and no material non-cancelable purchase commitments as of the reporting date[141]. - The company may face challenges in raising additional funds due to potential worsening global economic conditions and geopolitical tensions[139]. Operating Expenses and Losses - Research and development expenses decreased to $2.972 million for the three months ended March 31, 2025, from $4.903 million in the same period of 2024, a reduction of $1.931 million[120]. - General and administrative expenses were $2.688 million for the three months ended March 31, 2025, down from $3.742 million in the prior year, reflecting a decrease of $1.054 million[120]. - The total operating expenses for the three months ended March 31, 2025, were $5.660 million, compared to $8.645 million for the same period in 2024, a decrease of $2.985 million[120]. - The net loss for the three months ended March 31, 2025, was $5.550 million, an improvement of $3.012 million compared to a net loss of $8.562 million in the prior year[120]. - As of March 31, 2025, the company had cash of $11.9 million, which is expected to fund operations into March 2026[125]. - The company reported a net increase in cash and restricted cash of $771,000 for the three months ended March 31, 2025[142]. Regulatory and Reporting Status - The company adopted ASU 2023-07 effective January 1, 2025, which requires enhanced disclosures about reportable segments[155]. - The company is classified as a "smaller reporting company" with a market value threshold of $250.0 million for non-affiliates[160]. - Annual revenue must be less than $100.0 million to maintain smaller reporting company status, alongside a market value of less than $700.0 million[160]. - As a smaller reporting company, the company can present only the two most recent fiscal years of audited financial statements in its Annual Report[161]. - Reduced disclosure obligations regarding executive compensation apply to the company as a smaller reporting company[161]. - The company is not required to provide certain market risk disclosures due to its classification as a smaller reporting company[162].