Galera(GRTX) - 2022 Q2 - Quarterly Report

Financial Performance - Net loss for the three months ended June 30, 2022, was $14,558,000, compared to a net loss of $22,386,000 for the same period in 2021, indicating a 35% improvement year-over-year[16]. - The company reported a comprehensive loss of $14,607,000 for the three months ended June 30, 2022, compared to a comprehensive loss of $22,393,000 for the same period in 2021, showing a 35% reduction[19]. - The company's net loss was $14.6 million for the three months ended June 30, 2022, and $30.0 million for the six months ended June 30, 2022, compared to $80.5 million for the year ended December 31, 2021[82]. - Total operating expenses for the three months ended June 30, 2022, were $11.9 million, a decrease of $9.1 million from $21.1 million for the same period in 2021[103]. Assets and Liabilities - Total current assets decreased from $77,392,000 as of December 31, 2021, to $55,188,000 as of June 30, 2022, representing a decline of approximately 29%[14]. - Total liabilities increased from $141,315,000 as of December 31, 2021, to $144,324,000 as of June 30, 2022, marking a rise of approximately 2%[14]. - The total stockholders' deficit increased from $58,004,000 as of December 31, 2021, to $83,246,000 as of June 30, 2022, representing a decline of approximately 43%[14]. - As of June 30, 2022, the company had $52.0 million in cash, cash equivalents, and short-term investments, with an accumulated deficit of $346.1 million[112]. Cash Flow - Cash and cash equivalents at the end of the period were $17,376,000, down from $19,859,000 at the beginning of the period, reflecting a decrease of 12.5%[24]. - Cash used in operating activities for the six months ended June 30, 2022, was $20,271,000, a decrease from $32,108,000 in the same period of 2021, indicating improved cash flow management[24]. - During the six months ended June 30, 2022, the company used $20.3 million in net cash for operating activities, reflecting a net loss of $30.0 million[115]. - The company generated $16.6 million in cash from investing activities during the six months ended June 30, 2022, primarily from net sales of short-term investments[117]. Research and Development - Research and development expenses for the six months ended June 30, 2022, were $28,389,000, a decrease of 10% from $31,758,000 in the same period of 2021[16]. - Research and development expenses for the six months ended June 30, 2022, totaled $14.8 million, down from $28.4 million for the same period in 2021, reflecting a significant reduction in clinical trial costs[105]. - Avasopasem development costs decreased by $12.9 million for the six months ended June 30, 2022, primarily due to reduced clinical trial expenses as the ROMAN, EUSOM, and AESOP trials completed enrollment in 2021[106]. - The company plans to submit a New Drug Application for avasopasem to the FDA by the end of 2022[28]. Stock and Financing - The weighted-average shares of common stock outstanding increased from 25,401,046 in Q2 2021 to 26,821,303 in Q2 2022, reflecting an increase of approximately 5.6%[16]. - The company sold 314,296 shares under the Sales Agreement at a weighted average price of $3.70, generating net proceeds of $1.1 million[111]. - The Royalty Agreement with Blackstone Life Sciences allows the company to receive up to $117.5 million in total, contingent on achieving specified clinical milestones[127]. - The company may need to rely on additional financing to achieve business objectives, as commercial revenues are not expected for the next couple of years[122]. Compliance and Risks - The company received a notice from Nasdaq indicating non-compliance with the minimum Market Value of Listed Securities of $50.0 million, with a compliance deadline of December 5, 2022[86]. - If the company does not regain compliance, it may face delisting from Nasdaq, which could adversely affect its business and stock price[143]. - Investing in the company's common stock involves a high degree of risk, and additional risks may impair business operations[141]. - There have been no material changes to the risk factors described in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2021[141].