Aerovate Therapeutics Inc Reports Increased R&D Expenses and Net Loss in Q3

In this article:
  • Aerovate Therapeutics Inc (NASDAQ:AVTE) reported a net loss of $19.6 million for Q3 2023, up from $13.6 million in Q3 2022.

  • R&D expenses rose to $16.9 million, driven by higher costs associated with clinical trials and headcount.

  • The company's cash reserves are expected to fund operations into 2026, with a current total of $135.2 million.

On November 13, 2023, Aerovate Therapeutics Inc (NASDAQ:AVTE) released its 8-K filing, detailing the financial results for the third quarter ended September 30, 2023, and providing updates on its business operations. The clinical-stage biopharmaceutical company, which focuses on rare cardiopulmonary diseases, has reported a net loss and an increase in both research and development (R&D) and general and administrative (G&A) expenses.

Financial Performance

Aerovate Therapeutics Inc (NASDAQ:AVTE) has seen its R&D expenses climb to $16.9 million in Q3 2023, a significant increase from $10.8 million in the same quarter of the previous year. This rise is attributed to expanded clinical trial activities, contract manufacturing costs, and an increase in headcount. G&A expenses also grew to $4.5 million, up from $3.4 million in Q3 2022, primarily due to higher personnel-related costs.

The company's net loss widened to $19.6 million for the quarter, compared to a net loss of $13.6 million in Q3 2022. This net loss included stock-based compensation expenses of $3.2 million for the current quarter, an increase from $1.5 million in the corresponding quarter of the previous year.

Liquidity and Capital Resources

Aerovate Therapeutics Inc (NASDAQ:AVTE) reported cash, cash equivalents, and available-for-sale securities totaling $135.2 million as of September 30, 2023, an increase from $129.2 million at the end of 2022. The company attributes this increase to net proceeds from its "at-the-market" program, which have helped offset operational costs for the nine-month period. The financial guidance provided by AVTE suggests that these funds will be sufficient to support the company's operations into 2026, based on its current operating plan.

Business Highlights and Future Outlook

AVTE has made significant strides in its clinical development, with the IMPAHCT Global Phase 2b/Phase 3 Clinical Trial for its leading candidate, AV-101, progressing as planned. The company expects to report topline data from the Phase 2b portion of the trial in the second quarter of 2024. Additionally, AVTE has expanded its intellectual property portfolio, securing a new patent and continuing to prosecute multiple applications globally.

AV-101, a dry powder inhaled formulation of imatinib, is designed to treat pulmonary arterial hypertension (PAH) and is currently being evaluated in the IMPAHCT trial. The trial aims to determine the safety and efficacy of AV-101 in adults with PAH, with a primary endpoint of change in pulmonary vascular resistance (PVR) for Phase 2b and six-minute walk distance (6MWD) for Phase 3.

Despite the increased net loss and operational expenses, Aerovate Therapeutics Inc (NASDAQ:AVTE) remains committed to advancing its clinical programs and strengthening its financial position. The company's focus on developing treatments for rare cardiopulmonary diseases continues to drive its research and development efforts, with the anticipation of delivering meaningful improvements to patients' lives.

For more detailed information, readers can access the full financial statements and business highlights in the company's 8-K filing.

Explore the complete 8-K earnings release (here) from Aerovate Therapeutics Inc for further details.

This article first appeared on GuruFocus.

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