Financial Performance - The company reported a net loss of $11.0 million for the six months ended June 30, 2025, with total operating expenses of $13.1 million[153]. - Net loss for Q2 2025 was $5.96 million, representing a 51% increase compared to a net loss of $3.95 million in Q2 2024[169]. - Total operating expenses for the first half of 2025 were $13.12 million, an increase of 7% from $12.30 million in the first half of 2024[173]. - Research and development expenses for the first half of 2025 rose by 17% to $8.28 million, compared to $7.10 million in the first half of 2024[173]. - Other income for Q2 2025 was $0.67 million, a significant decrease of 74% from $2.58 million in Q2 2024[172]. - Other income for the first half of 2025 was $2.12 million, down 75% from $8.47 million in the first half of 2024[175]. - Cash used in operating activities was $11.5 million for the six months ended June 30, 2025, primarily due to the net loss and changes in operating assets and liabilities[194]. - The company has experienced significant operating losses since inception, except for a brief period ending March 31, 2024[192]. Cash and Capital Resources - As of June 30, 2025, the company had an accumulated deficit of $170.8 million and $18.0 million in cash, cash equivalents, and short-term investments[153]. - The company expects to fund its current operating plan into the middle of 2026 with existing cash resources[153]. - The company anticipates needing to raise substantial additional capital to fund product candidates through regulatory approval and further clinical work[178]. - There is substantial doubt about the company's ability to continue as a going concern without additional financing[178]. - The company expects to finance future cash requirements through existing cash, equity offerings, and debt financing, but additional capital raising cannot be assured[183]. - Cash provided by financing activities for the six months ended June 30, 2025, was $10.6 million, primarily from debt financing[197]. - The company raised gross proceeds of $20.4 million from a private placement transaction in January 2024, with net proceeds of approximately $19.0 million after transaction costs[149]. - The company closed an underwritten public offering of 2,720,000 shares at a price of $3.75 per share, generating gross proceeds of $10.2 million[150]. - The company entered into a Loan and Security Agreement for growth capital loans totaling up to $32.5 million, with $10 million funded on the closing date[152]. - The company entered into a Loan Agreement for growth capital loans totaling up to $32.5 million, with specific tranches subject to achieving milestones[189]. - The company filed a Shelf Registration Statement allowing for the offering of up to $100.0 million in various securities, including common stock[184]. Research and Development - The company has conducted multiple Phase 2 clinical trials for its lead product candidate, Auxora, showing a reduction in organ damage and recovery time in treated patients[145]. - The company anticipates data from a Phase 2 trial for acute kidney injury with associated acute hypoxemic respiratory failure in early 2026[145]. - The company expects research and development expenses to increase substantially as it continues to invest in clinical trials and regulatory approvals[159]. - Research and development expenses for Q2 2025 were $4.1 million, a decrease of 3% from $4.2 million in Q2 2024[170]. - The company incurs substantial expenses related to clinical trials, with costs estimated based on the number of services provided but not yet invoiced[203]. - The company has not experienced any material differences between accrued costs and actual costs incurred since its inception[204]. - Clinical trial expenses are accrued based on contracted amounts applied to patient enrollment and activity levels[205]. Company Classification and Accounting - The company is classified as an emerging growth company and will cease this status on December 31, 2025[209]. - The company qualifies as a smaller reporting company, with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million[210]. - As a smaller reporting company, the company may present only the two most recent fiscal years of audited financial statements in its Annual Report[210]. - No recently adopted accounting pronouncements were noted[211]. - The company is not required to provide market risk disclosures due to its smaller reporting company status[213]. Lease Obligations - The company has a lease obligation with a monthly rent expense of approximately $10,000, which is expected to total approximately $63,000 over the next six months[198][199].
Grayscale Investments(GRAY) - 2025 Q2 - Quarterly Report