Financial Performance - The company reported a net loss of $55.2 million for the year ended December 31, 2019, compared to a net loss of $30.1 million for the year ended December 31, 2018, resulting in an accumulated deficit of $258.5 million as of December 31, 2019[297]. - Net loss for 2019 was $55.2 million, compared to a net loss of $30.1 million in 2018, representing an increase of 84%[318]. - Cash used in operating activities was $43.6 million in 2019, up from $28.6 million in 2018, reflecting a significant increase in net loss[321]. - Interest and other income decreased by 44% to $2.1 million in 2019 from $3.8 million in 2018, primarily due to the absence of significant milestone payments[315]. Research and Development - Research and development expenses for the year ended December 31, 2019, totaled $43.9 million, significantly increasing from $21.5 million in 2018, with clinical manufacturing costs rising from $12.2 million to $26.1 million[301]. - Research and development expenses increased by 104% to $43.9 million in 2019 from $21.5 million in 2018, primarily due to increased manufacturing activities and personnel-related expenses[312]. - The company expects research and development expenses to increase materially in 2020 due to costs associated with clinical trials and manufacturing[313]. - The company completed a Phase 1/2 SQ dosing trial for DalcA, achieving protective Factor IX activity levels of 12-30% with no reported serious adverse events[288]. - MarzAA, the company's most advanced product candidate, is currently in a SQ Phase 1 study to evaluate its pharmacokinetics and pharmacodynamics, with interim data indicating target levels consistent with treating a bleed[286]. Collaborations and Funding - The company entered into a collaboration agreement with Biogen, receiving a $15 million upfront payment and being eligible for up to $340 million in milestone payments for the development of anti-C3 proteases[290]. - The company raised approximately $32 million from the sale of 5,307,692 shares of common stock at $6.50 per share in February 2020[295]. - The company plans to fund future losses and capital needs through equity and/or debt financings, with effective registration statements allowing for the sale of up to $200.0 million in securities[319]. Cash and Investments - As of December 31, 2019, the company had cash, cash equivalents, and short-term investments totaling $76.9 million[297]. - Cash provided by investing activities was $27.4 million in 2019, primarily due to $157.4 million in proceeds from maturities of investments[324]. - As of December 31, 2019, the company had $76.9 million in cash, cash equivalents, and short-term investments, with an accumulated deficit of $258.5 million[318]. Operating Expenses - General and administrative expenses rose by 9% to $13.4 million in 2019 from $12.4 million in 2018, driven by higher personnel-related costs[314]. - The company expects to incur significant expenses and increasing operating losses for at least the next several years as it continues clinical development and seeks regulatory approval for its drug candidates[298]. Manufacturing and Agreements - The company has a long-term development and manufacturing services agreement with AGC Biologics for drug substance manufacturing, successfully completing a GMP batch of MarzAA to support future studies[292]. - The company has firm work orders totaling $12.4 million with AGC for the manufacture of MarzAA and DalcA to support clinical trials, with $4.6 million still outstanding[304]. - Contract revenue decreased to $0.0 million in 2019 from $0.01 million in 2018, a decline of 100% due to the end of a collaboration agreement[311]. Lease Accounting - The company adopted the new lease accounting standard ASC 842 on January 1, 2019, using the optional transition method, which does not restate comparative financial information[344]. - Operating lease liabilities and corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term[345]. - The company utilizes its incremental borrowing rate for lease contracts, as the interest rate implicit in lease contracts is typically not readily determinable[345]. - Lease and non-lease components are combined as a single component, with lease expense recognized over the expected term on a straight-line basis[346]. - Operating leases are recognized on the balance sheet as right-of-use assets and operating lease liabilities, eliminating the recognition of deferred rent[346].
Gyre Therapeutics(GYRE) - 2019 Q4 - Annual Report