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KALA BIO, Inc. (Nasdaq: KALA) is a clinical-stage biopharmaceutical company that specializes in the development and commercialization of innovative therapies for rare and severe eye diseases. Leveraging its proprietary mesenchymal stem cell secretome (MSC-S) platform, KALA is pioneering treatments that aim to address significant unmet medical needs.
The company's lead product candidate, KPI-012, is a human MSC-S with numerous biofactors, such as growth factors, protease inhibitors, matrix proteins, and neurotrophic factors, aimed at correcting impaired corneal healing. Currently in Phase 2b clinical development for the treatment of persistent corneal epithelial defect (PCED), KPI-012 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration.
KALA BIO is also exploring the potential of KPI-012 for additional rare, front-of-the-eye diseases, such as Limbal Stem Cell Deficiency. Beyond KPI-012, the company has initiated preclinical studies for KPI-014, targeting inherited retinal degenerative diseases like Retinitis Pigmentosa and Stargardt Disease.
Recent corporate updates show substantial progress, including a $15 million grant from the California Institute for Regenerative Medicine (CIRM) to support the KPI-012 program. Financially, the company reported having $56.1 million in cash and equivalents as of September 30, 2023, with resources expected to fund operations into 2025.
For more information, please visit www.kalarx.com.
KALA BIO has secured a $10.75 million private placement through the sale of common stock and Series I Convertible Non-Redeemable Preferred Stock to institutional investors, including SR One, Cormorant Asset Management, and Woodline Partners. The company will sell 1,340,603 common shares at $6.44 per share and 3,286 preferred shares at $644.00 per share.
The funding, expected to close by December 31, 2024, will extend KALA's operations into Q1 2026. Proceeds will support the clinical development of KPI-012 for persistent corneal epithelial defect. The CHASE trial has achieved over 80% enrollment across 40+ clinical sites, with topline data expected in Q2 2025.
KALA BIO (NASDAQ:KALA) has announced its participation in the Piper Sandler 36th Annual Healthcare Conference in New York. Kim Brazzell, Ph.D., Head of R&D and Chief Medical Officer, will deliver a presentation on December 4, 2024, at 11:30 a.m. ET. The company, which focuses on developing innovative therapies for rare and severe eye diseases, will also be available for one-on-one meetings during the conference. A webcast of the presentation will be accessible through the 'Presentations' section on KALA's website.
KALA BIO reported Q3 2024 financial results and provided updates on its Phase 2b CHASE trial of KPI-012 for Persistent Corneal Epithelial Defect (PCED). The company reported cash and equivalents of $49.2 million as of September 30, 2024, expecting to fund operations into Q4 2025. Q3 net loss was $9.0 million ($1.93 per share), compared to $8.7 million in Q3 2023. The company initiated five clinical trial sites in Argentina and expects topline results from the CHASE trial in Q2 2025. KPI-012 aims to be a first-in-class treatment for PCED, targeting an estimated U.S. market of 100,000 patients.
KALA BIO (NASDAQ:KALA), a clinical-stage biopharmaceutical company focused on innovative therapies for rare and severe eye diseases, has announced its participation in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference. Kim Brazzell, Ph.D., Head of R&D and Chief Medical Officer, will deliver a pre-recorded presentation available from August 15, 2024, at 7:00 a.m. ET.
The company's management team will also be available for virtual one-on-one meetings throughout the conference. Interested parties can access the webcast and subsequent recording of the presentation through the 'Presentations' section of KALA BIO's website at www.kalarx.com.
KALA BIO (NASDAQ:KALA) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
- Closed a $12.5 million private placement financing
- Cash resources of $54.2 million as of June 30, 2024
- Funding expected to last into Q4 2025
- Topline data from Phase 2b CHASE trial of KPI-012 for PCED targeted in Q1 2025
The company is advancing its MSC-S platform technology, focusing on KPI-012 for PCED and exploring potential in other eye diseases. Q2 2024 financial results show a net loss of $9.6 million, or $3.16 per share, compared to $10.4 million, or $4.36 per share, in Q2 2023.
KALA BIO, a clinical-stage biopharmaceutical company, announced a private placement agreement with institutional investors to sell 1,197,314 shares of common stock at $5.85 per share and 9,393 shares of Series H Preferred Stock at $585.00 per share, raising approximately $12.5 million before expenses.
The placement, led by SR One with participation from ADAR1 Capital Management and another life sciences-focused investor, is set to close around June 28, 2024, pending customary conditions. Net proceeds will fund the clinical development of KPI-012 for persistent corneal epithelial defects and general corporate purposes.
The securities are unregistered under the Securities Act of 1933 and will only be offered via a prospectus. KALA will file a registration statement with the SEC within 30 days post-closing for resale purposes.
KALA BIO (NASDAQ:KALA) will present at the Jefferies Global Healthcare Conference on June 5, 2024, in New York, NY. Kim Brazzell, Ph.D., Head of R&D and Chief Medical Officer, will deliver the presentation at 12:30 p.m. ET. The company's management team is also available for one-on-one meetings on the same day. The presentation's webcast and archived recording will be accessible on the KALA website.
KALA BIO (NASDAQ: KALA) released its first quarter 2024 financial results and corporate update, emphasizing ongoing patient enrollment in the Phase 2b CHASE trial for KPI-012 targeting persistent corneal epithelial defect (PCED), with topline data expected by year-end 2024.
The company is also exploring KPI-012 for other corneal diseases like Limbal Stem Cell Deficiency (LSCD) and the preclinical KPI-014 for inherited retinal diseases.
As of March 31, 2024, KALA had cash resources of $48.5 million, expected to fund operations into 3Q 2025. First-quarter financials revealed a net loss of $11.8 million ($4.20 per share), compared to a $14.5 million loss ($6.99 per share) in the same period in 2023. G&A expenses decreased to $5.4 million, while R&D expenses increased to $6.4 million.
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