Loading...
•
Jan 31
KalVista Q3 2025 Earnings Report
KalVista Pharmaceuticals, Inc. reported a net loss of $48.51 million and an EPS of -$0.92 for the three months ended January 31, 2025.
Key Takeaways
KalVista Pharmaceuticals, Inc. experienced a significant net loss of $48.51 million in the third quarter of fiscal year 2025, with a diluted EPS of -$0.92. Operating expenses increased, driven by a substantial rise in general and administrative costs, while research and development expenses decreased. The company's financial position was bolstered by proceeds from a royalty agreement and common stock issuance.
Net loss for the three months ended January 31, 2025, was $48.509 million, compared to $29.028 million in the same period last year, indicating a significant increase in losses.
Diluted net loss per share was -$0.92 for the current quarter, worsening from -$0.84 in the prior year's comparable quarter.
General and administrative expenses surged to $30.346 million from $10.628 million in the prior year, primarily due to increased personnel and commercial strategy costs.
Research and development expenses decreased to $12.594 million from $22.523 million, mainly due to the completion of the Phase 3 KONFIDENT trial.
KalVista
KalVista
Forward Guidance
KalVista anticipates continued losses and increased expenses as it progresses product development and commercialization efforts for sebetralstat. The company expects to fund operations for at least the next twelve months through existing capital resources and potential future financings.
Positive Outlook
- The company has sufficient funding to operate for at least the next twelve months based on current operating plans and capital resources.
- Potential for future financing through equity offerings, debt financing, corporate partnerships, and product sales.
- Sebetralstat has received Fast Track and Orphan Drug designations from the FDA, and an Innovation Passport from the MHRA.
- Submitted a New Drug Application (NDA) with the U.S. FDA for sebetralstat, with a PDUFA notification date of June 17, 2025.
- Submitted Marketing Authorization Applications (MAA) for sebetralstat to the European Medicines Agency (EMA) and other regulatory authorities, with a Japanese New Drug Application submitted in January 2025.
Challenges Ahead
- The company has not generated any product sales revenues to date and does not expect to generate significant revenue until regulatory approval and commercialization.
- Anticipates continued and increasing losses as development and commercialization efforts progress.
- Subject to risks and uncertainties common in the pharmaceutical industry, including unforeseen expenses, difficulties, and delays.
- Failure to obtain regulatory approval for product candidates would materially adversely affect business and prospects.
- Additional capital raises through equity or debt may dilute ownership interest or involve restrictive covenants.