Evelo Biosciences(US:EVLO)2022-08-11 10:46Financial Performance - Net loss for the six months ended June 30, 2022, was $60.422 million, slightly higher than the $59.794 million loss for the same period in 2021[25]. - Net loss for the three months ended June 30, 2022, was $30.6 million, compared to a net loss of $31.6 million for the same period in 2021, representing a decrease of 3.3%[112]. - For the six months ended June 30, 2022, the company reported a net loss of $60.4 million, with an accumulated deficit of $475.1 million as of the same date[166]. - Net loss for the six months ended June 30, 2022, was $60.4 million, compared to $59.8 million for the same period in 2021, reflecting a $3.2 million loss on debt extinguishment recognized last year[209]. Assets and Liabilities - Total assets increased to $111.901 million as of June 30, 2022, up from $87.871 million at December 31, 2021, representing a growth of 27.3%[15]. - Total liabilities decreased to $76.253 million from $79.204 million, a reduction of 3.7%[15]. - Stockholder's equity increased to $35.648 million as of June 30, 2022, up from $8.667 million at the end of 2021, representing a growth of 311.5%[15]. - As of June 30, 2022, the company held cash, cash equivalents, and restricted cash totaling $93.2 million, with an accumulated deficit of $475.1 million[29]. Cash Flow - Cash and cash equivalents rose to $92.007 million, compared to $68.441 million at the end of 2021, marking an increase of 34.4%[15]. - Net cash used in operating activities for the six months ended June 30, 2022, was $55.458 million, compared to $41.712 million in 2021, indicating a 32.9% increase in cash outflow[25]. - Cash and cash equivalents increased from $68.4 million as of December 31, 2021, to $92.0 million as of June 30, 2022, representing a growth of approximately 34.5%[41]. Expenses - Total operating expenses for the six months ended June 30, 2022, were $58.325 million, compared to $55.127 million in the same period of 2021, an increase of 4.0%[17]. - Total operating expenses for the three months ended June 30, 2022, were $29.6 million, an increase of $1.9 million from $27.7 million in the prior year[200]. - Research and development expenses for the six months ended June 30, 2022, were $40.5 million, down from $42.2 million in the same period of 2021, due to the completion of certain trials[210]. - General and administrative expenses for the six months ended June 30, 2022, were $17.8 million, an increase of $4.8 million compared to $13.0 million in the prior year, driven by higher personnel costs and stock-based compensation[212]. Research and Development - Research and development expenses for Q2 2022 were $21.221 million, up from $20.655 million in Q2 2021, reflecting a 2.7% increase[17]. - The company has not generated any product or license revenue to date, focusing primarily on research and development[28]. - The company expects significant increases in expenses related to ongoing clinical trials for EDP1815 and EDP2939, as well as strategic investments in manufacturing capabilities[167]. - EDP1815, the most advanced product candidate, is being developed for the treatment of inflammatory diseases, with positive Phase 2 trial results showing a PASI-50 response rate of 29% compared to 12% for placebo[129]. Funding and Capital - Proceeds from the issuance of common stock, net of issuance costs, amounted to $79.092 million during the six months ended June 30, 2022[25]. - The company plans to obtain additional funding through public offerings, private financing, or strategic partnerships to support its operations[30]. - In February 2021, the company completed a public offering of 5,175,000 shares at $15.00 per share, generating gross proceeds of $77.6 million and net proceeds of $72.7 million[88]. - In May 2022, the company conducted a registered direct offering of 54,246,358 shares at $1.46 per share, resulting in gross proceeds of $79.2 million[92]. Stock and Equity - The company reported a weighted-average number of common shares outstanding of 75,719,092 for Q2 2022, compared to 53,379,415 for Q2 2021, an increase of 41.8%[17]. - As of June 30, 2022, the company had total unrecognized stock-based compensation expense of $28.5 million, expected to be recognized over a weighted average period of 2.6 years[105]. - The company issued 2,032,505 stock options during the six months ended June 30, 2022, with a weighted average exercise price of $4.64[103]. Regulatory and Compliance - The company is classified as an "emerging growth company," allowing it to take advantage of reduced reporting requirements until it exceeds certain thresholds[35]. - The European Medicines Agency approved a Pediatric Investigation Plan for EDP1815, allowing inclusion of patients aged 12-17 in Phase 3 trials and requiring trials for younger age groups post-Marketing Authorization Application[148]. Strategic Collaborations - A strategic collaboration with Meddist Company Limited aims to develop and commercialize EDP1815 in the Middle East, Turkey, and Africa, addressing healthcare access disparities[160]. - A collaboration agreement with ALJ will result in the recognition of $7.5 million in revenue upon regulatory approval of EDP1815 in designated markets[182].