Summit Therapeutics (US:SMMT)2023-08-09 20:03Financial Performance - Revenue for the three months ended June 30, 2023, was $0, compared to $0.2 million for the same period in 2022, and for the six months ended June 30, 2023, revenue was $0.5 million, down from $0.5 million in 2022[141]. - Total operating expenses for the three months ended June 30, 2023, were $15.8 million, slightly down from $15.9 million in 2022, while for the six months ended June 30, 2023, total operating expenses surged to $553.5 million from $43.2 million in 2022[141]. - The company reported a net loss of $14.7 million for the three months ended June 30, 2023, compared to a net loss of $16.8 million in 2022, and a net loss of $557.0 million for the six months ended June 30, 2023, compared to $38.2 million in 2022[141]. Research and Development - Research and development expenses for the three months ended June 30, 2023, were $9.5 million, compared to $9.0 million in 2022, and for the six months ended June 30, 2023, they were $19.3 million, down from $29.6 million in 2022[141]. - The company has shifted its focus from anti-infectives to oncology, resulting in a decrease of $10.3 million in research and development expenses during the six months ended June 30, 2023, compared to the same period in the prior year[146]. - The company plans to invest in the clinical development of ivonescimab and expand its intellectual property portfolio[166]. Clinical Trials and Studies - The company plans to initiate Phase III clinical studies for ivonescimab in non-small cell lung cancer (NSCLC), with the first patient enrolled in the Phase III HARMONi study on May 9, 2023[137]. - The company reported a median progression-free survival of 11.0 months and an overall response rate of 67% in patients treated with ivonescimab in a Phase II study[138]. - The company anticipates potential delays or issues in clinical trials, regulatory challenges, and the need for additional funding to support ongoing operations[169][170]. Financing and Capital Structure - The company raised $500,000 from the 2023 Rights Offering, selling 476,190,471 shares at $1.05 per share[133]. - The company increased the number of authorized shares of common stock by 650 million, from 350 million to 1 billion, effective January 19, 2023[134]. - The company received net proceeds of $25.0 million from the issuance of unsecured promissory notes on March 10, 2022[162]. - The company issued unsecured promissory notes totaling $520 million to its Co-CEOs in December 2022, with varying maturity dates[163]. - The company has a $100 million promissory note payable to a related party maturing on September 6, 2024, and intends to raise additional capital or seek an extension for repayment[168]. Cash Flow and Financial Position - For the six months ended June 30, 2023, the company incurred a net loss of $557.1 million and cash flows used in operating activities were $42.4 million[167]. - As of June 30, 2023, the company had an accumulated deficit of $935.4 million and cash and cash equivalents of $42.1 million[167]. - The company plans to fund its operating costs and working capital needs for at least the next twelve months with existing financial resources[168]. - Net cash used in investing activities for the six months ended June 30, 2023, was $644.9 million, primarily due to a $475.0 million upfront payment to Akeso[172][175]. - Net cash provided by financing activities was $80.0 million for the six months ended June 30, 2023, mainly from the issuance of common stock[177]. Other Income and Expenses - General and administrative expenses decreased by $0.6 million for the three months ended June 30, 2023, compared to the same period in the prior year, totaling $6.3 million[150]. - Stock-based compensation decreased by $1.2 million for the three months ended June 30, 2023, due to awards becoming fully amortized and lower fair values compared to the prior period[150]. - U.K. research and development tax credits decreased by $0.8 million for the three months ended June 30, 2023, due to reduced clinical and manufacturing activity spend[154]. - Funding income from BARDA decreased by $1.2 million for the three months ended June 30, 2023, as the BARDA contract ended in 2022[155]. - Grant income from CARB-X decreased by $1.0 million for the three months ended June 30, 2023, due to the conclusion of the CARB-X arrangement in 2022[156]. - Other income (expense), net increased by $5.2 million for the three months ended June 30, 2023, primarily due to favorable changes in foreign currency gains and increased interest income[159]. Commitments and Future Plans - The company has approximately $6.9 million of non-cancellable purchase commitments associated with clinical trials as of June 30, 2023[183]. - The company aims to establish a sales, marketing, and distribution infrastructure in jurisdictions where it retains commercialization rights[166]. - The company expects to continue incurring significant expenses and increasing operating losses for at least the next few years due to ongoing research and development efforts[165].