Avenue Therapeutics (ATXI) Q2 2024 earnings summary

Executive summary

• Net loss for the six months ended June 30, 2024 was $7.1 million, a 39% improvement year-over-year; accumulated deficit reached $98.0 million as of June 30, 2024.

• Completed last patient visit in Phase 1b/2a trial of AJ201 for SBMA; topline data expected in H2 2024.

• Research and development expenses decreased 55% to $1.4 million for Q2 2024, mainly due to lower clinical development costs.

• General and administrative expenses increased 63% to $1.5 million in Q2 2024, driven by higher payments to InvaGen, stock issued to Fortress, and increased stock compensation.

• Company remains pre-revenue, focused on developing AJ201 for SBMA, IV tramadol for acute pain, and BAER-101 for epilepsy and panic disorders.

Financial highlights

• Cash and cash equivalents were $4.9 million as of June 30, 2024, up from $1.8 million at year-end 2023.

• Net loss attributable to common stockholders for Q2 2024 was $2.7 million ($6.43/share), compared to $4.0 million ($38.74/share) in Q2 2023.

• Net cash used in operating activities was $5.4 million for the first half of 2024, down from $6.2 million in the prior year period.

• Net cash provided by financing activities was $8.5 million in the first half of 2024, mainly from warrant exercises and ATM sales.

• R&D expenses for Q2 2024 were $1.4 million, down from $3.0 million in Q2 2023; G&A expenses for Q2 2024 were $1.5 million, up from $0.9 million in Q2 2023.

Outlook and guidance

• Topline data from the AJ201 Phase 1b/2a trial is anticipated in the second half of 2024.

• Initiation of the IV tramadol Phase 3 safety study and BAER-101 Phase 2a trial is planned, pending necessary financing.

• Additional capital will be required to fund operations beyond Q1 2025; various financing alternatives are being evaluated.