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Sep 30, 2023
Kala Bio Q3 2023 Earnings Report
KALA BIO reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.
Key Takeaways
KALA BIO reported a net loss of $8.7 million for the third quarter of 2023, with research and development expenses at $5.6 million and selling, general and administrative expenses at $5.0 million. The company's cash and cash equivalents totaled $56.1 million as of September 30, 2023, expected to fund operations into the second quarter of 2025.
Enrollment is ongoing in the CHASE Phase 2b clinical trial of KPI-012 for PCED, with topline data expected in the second half of 2024.
KALA BIO had $56.1 million in cash and cash equivalents as of September 30, 2023.
Cash resources, combined with anticipated funding from CIRM, are expected to fund operations into the second quarter of 2025.
KALA is advancing its MSC-S pipeline and exploring opportunities to expand KPI-012 into additional corneal indications.
Kala Bio
Kala Bio
Forward Guidance
KALA BIO anticipates that its cash resources as of September 30, 2023, together with anticipated remaining funding under the CIRM award, will enable it to fund operations into the second quarter of 2025.
Positive Outlook
- KPI-012 has the potential to correct the impaired corneal healing.
- CHASE Phase 2b trial could serve as the first of two pivotal trials to support the submission of a BLA to the FDA.
- KALA plans to pursue research and development of KPI-012 and its MSC-S platform for other indications.
- KALA expects benefits and future operation of the CIRM award.
- KALA expects to achieve the specified milestones and obtain the full funding under the CIRM award.
Challenges Ahead
- KALA's ability to comply with the requirements under the CIRM award is uncertain.
- There are uncertainties inherent in the initiation and conduct of preclinical studies and clinical trials.
- The availability and timing of data from clinical trials are uncertain.
- The results of early clinical trials may not be indicative of the results of ongoing or future trials.
- The pandemic health event resulting from the coronavirus (COVID-19), and their collateral consequences.