Syndax(US:SNDX)2023-08-03 20:06Financial Performance - For the six months ended June 30, 2023, the company reported a net loss of $85.7 million, compared to a net loss of $74.7 million for the same period in 2022, resulting in an accumulated deficit of $778.8 million as of June 30, 2023[62]. - The company has an accumulated deficit of $778.8 million as of June 30, 2023, and anticipates continued significant losses for the next several years[104]. - Net cash used in operating activities for the six months ended June 30, 2023, was $74.6 million, reflecting a net loss of $85.7 million adjusted for non-cash items[106]. - Net cash used in operating activities for the six months ended June 30, 2022, was $82.2 million, primarily due to a net loss of $74.7 million and increased clinical trial activities[107]. Research and Development - Research and development expenses for the three months ended June 30, 2023, increased by $5.0 million, or 17%, to $34.8 million from $29.7 million in the prior year, primarily due to increased employee-related expenses[83]. - Total research and development expenses for the three months ended June 30, 2023, increased by $5.0 million, or 17%, to $34.8 million compared to $29.7 million in the prior year[84]. - Total research and development expenses for the six months ended June 30, 2023, increased by $9.1 million, or 15%, to $68.8 million from $59.8 million in the prior year[90]. - The pivotal Phase 2 portion of AUGMENT-101 is enrolling patients with relapsed/refractory acute leukemias, with an NDA filing expected by the end of 2023[64]. - The company plans to submit a New Drug Application (NDA) for revumenib by the end of 2023, with topline data from a pooled analysis of KMT2Ar cohorts expected in Q3 2023[64]. - The company expects to initiate a trial assessing axatilimab in combination with Jakafi® for chronic graft-versus-host disease by year-end 2023[70]. - Axatilimab demonstrated an overall response rate of 74%, 67%, and 50% across three dose cohorts in the pivotal Phase 2 AGAVE-201 trial for chronic graft-versus-host disease[64]. Operating Expenses - Total operating expenses for the three months ended June 30, 2023, were $49.7 million, an increase of 32% compared to $37.7 million in the same period of 2022[82]. - Total operating expenses for the six months ended June 30, 2023, increased by $21.1 million, or 28%, to $95.7 million from $74.6 million in the prior year[89]. - General and administrative expenses for the three months ended June 30, 2023, rose by $6.9 million, or 87%, to $14.9 million from $8.0 million in the same period last year[85]. Cash and Investments - As of June 30, 2023, the company had cash, cash equivalents, and short and long-term investments totaling $418.3 million, expected to fund operations for at least the next 12 months[96]. - As of June 30, 2023, the company had cash and cash equivalents of $97.3 million and short-term investments of $301.5 million[112]. - Net cash provided by investing activities for the six months ended June 30, 2023, was $93.8 million, resulting from $236.4 million in proceeds from the maturities of available-for-sale securities[108]. - The company entered into a new sales agreement in May 2023, allowing for the issuance and sale of shares with aggregate sales proceeds of up to $200.0 million[98]. Interest Income - Interest income for the three months ended June 30, 2023, increased by 491% to $5.2 million, compared to $0.9 million in the prior year[82]. - Interest income for the three months ended June 30, 2023, increased by $4.3 million to $5.2 million from $0.9 million in the prior year, primarily due to higher interest rates and increased average balances[86]. - Interest income for the six months ended June 30, 2023, increased by $9.2 million to $10.3 million from $1.1 million in the prior year[93]. Market Conditions - The company does not expect significant effects on operating results or cash flows from changes in market interest rates due to the ability to hold investments until maturity[112]. - The company does not believe inflation and changing prices significantly impacted its results of operations for the periods presented[113].