Syndax Pharmaceuticals (SNDX) Q2 2024 earnings summary

Executive summary

• Anticipated FDA approvals for revumenib (KMT2A-rearranged acute leukemias) and axatilimab (chronic GVHD) position the company for commercial-stage transformation in 2024, with launches planned upon approval.

• Multiple positive clinical milestones achieved, including updated data from BEAT AML, AUGMENT-102, and AGAVE-201 trials, supporting efficacy and safety of both lead assets.

• Commercial launch preparations are advanced, with experienced teams, robust market access strategies, and targeted physician engagement.

• For Q2 2024, net loss was $68.1 million, with an accumulated deficit of $1.0 billion as of June 30, 2024.

• Cash, cash equivalents, and investments totaled $454.6–$455 million as of June 30, 2024, expected to fund operations through 2026.

Financial highlights

• Cash, cash equivalents, and investments totaled $454.6–$455 million as of June 30, 2024.

• Q2 2024 net loss was $68.1 million, or $0.80 per share, compared to $44.6 million, or $0.64 per share, in Q2 2023.

• Q2 operating expenses were $77.7 million, including $48.7 million in R&D and $29.1 million in SG&A.

• Q2 2024 revenue was $3.5 million, up from $0 in Q2 2023, due to milestone achievement for entinostat in China.

• Full-year 2024 guidance: R&D expense of $240–$260 million; total operating expenses of $355–$375 million, including $43 million in non-cash stock compensation.

Outlook and guidance

• Axatilimab PDUFA date: August 28, 2024; expected commercial launch in Q4 2024 with Incyte.

• Revumenib PDUFA date extended to December 26, 2024, due to FDA request for supplemental information; launch readiness maintained.

• Pivotal topline data for revumenib in NPM1 AML expected in Q4 2024, with sNDA filing planned for H1 2025.

• Q3 2024 guidance: R&D expense of $70–$75 million; total operating expenses of $105–$110 million.

• Sufficient capital to fund operations through 2026.