Galera(US:GRTX)2023-05-11 11:31Financial Performance - Net loss for the three months ended March 31, 2023, was $17,710,000, compared to a net loss of $15,443,000 for the same period in 2022, reflecting a 15% increase in losses[16] - The company reported a comprehensive loss of $17,672,000 for the three months ended March 31, 2023, compared to $15,490,000 for the same period in 2022, which is a 14% increase[19] - The company incurred a net loss of $62.2 million for the year ended December 31, 2022, and $17.7 million for the three months ended March 31, 2023, with an accumulated deficit of $396.0 million[93] - For the three months ended March 31, 2023, the net loss was $17.7 million, compared to a net loss of $15.4 million for the same period in 2022, representing an increase of $2.3 million[116] Assets and Liabilities - Total current assets increased to $54,243,000 as of March 31, 2023, compared to $38,535,000 as of December 31, 2022, representing a 41% increase[14] - The company’s total liabilities increased to $157,327,000 as of March 31, 2023, from $153,217,000 as of December 31, 2022, reflecting a 3% increase[14] - The company’s accumulated deficit reached $396,034,000 as of March 31, 2023, compared to $378,324,000 at the end of 2022, indicating an increase of 5%[14] - As of March 31, 2023, the company had $47.8 million in cash, cash equivalents, and short-term investments, expected to fund operations into Q4 2023[96] Research and Development - Research and development expenses decreased to $7,272,000 for Q1 2023, down from $8,107,000 in Q1 2022, indicating a 10% reduction[16] - Research and development expenses for the three months ended March 31, 2023, totaled $7.3 million, a decrease from $8.1 million in the same period of 2022[105] - The company has successfully completed Phase 1 trials of rucosopasem and is currently evaluating it in combination with SBRT in ongoing clinical trials[29] - The company is also developing rucosopasem to enhance the anti-cancer efficacy of stereotactic body radiation therapy, with ongoing clinical trials in patients with non-small cell lung cancer and locally advanced pancreatic cancer[87] Funding and Capital - The company raised $27,598,000 from the sale of common stock in a registered direct offering during Q1 2023[24] - The company completed a registered direct offering on February 17, 2023, resulting in gross proceeds of $30.0 million from the issuance of 14,320,000 shares of common stock and warrants[33] - The company expects to need substantial additional funding to support ongoing operations and product development, with existing cash expected to last into Q4 2023[131] - The Royalty Agreement with Blackstone Life Sciences allows for up to $80.0 million in funding based on clinical milestones, with the first three tranches already received[136] Commercialization and Market Potential - The company’s lead product candidate, avasopasem, targets a market opportunity of over $1.5 billion in the U.S. for the reduction of severe oral mucositis in head and neck cancer patients[79] - The Phase 3 ROMAN trial demonstrated a statistically significant reduction in the incidence of severe oral mucositis, with a median of 8 days in the avasopasem arm compared to 18 days in the placebo arm[80] - The company anticipates significant commercialization expenses if any product candidates receive marketing approval, impacting future financial performance[93] - The company expects to incur significant commercialization expenses related to manufacturing, product sales, marketing, and distribution if marketing approval is obtained for any product candidates[152] Legal and Compliance - The company is not subject to any material legal proceedings, indicating a stable legal environment[150] - The company has opted out of the extended transition period under the JOBS Act, committing to comply with new accounting standards as required for non-emerging growth companies[141] - The report includes certifications from the Principal Executive Officer and Principal Financial Officer under the Sarbanes-Oxley Act[164] Stock and Shareholder Information - The weighted-average shares of common stock outstanding increased to 35,196,134 in Q1 2023 from 26,749,379 in Q1 2022, representing a 31% increase[16] - The company has 7,269,032 stock options and 14,870,661 common stock warrants excluded from the computation of diluted weighted-average shares due to their anti-dilutive effect[46] - The company has 1,007,332 shares available for future issuance under the 2019 Incentive Award Plan as of March 31, 2023[68] - The company reserved 1,500,000 shares of common stock for issuance under the 2023 Employment Inducement Award Plan[70]