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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 Pharmaceuticals (NASDAQ:KALA) announced the addition of EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% to UnitedHealthcare's commercial formularies, expanding its coverage to approximately 118 million lives, or 70% of all commercial lives. Cigna Medicare also added EYSUVIS as a preferred brand, increasing its total Medicare coverage to 7.1 million lives, or 15%. EYSUVIS, approved by the FDA in October 2020, is the first FDA-approved treatment for short-term dry eye disease symptoms.
Kala Pharmaceuticals (NASDAQ:KALA) announced the granting of non-statutory stock options to a new employee as an inducement award on February 15, 2022. The options allow the purchase of up to 15,000 shares at an exercise price of $0.77, matching the closing stock price on the grant date. These options have a ten-year term and vest over four years, contingent on the employee's continued service. This move aligns with NASDAQ Listing Rule 5635(c)(4) and is part of the company’s strategy to attract talent to support its growth in innovative ocular therapies.
Kala Pharmaceuticals (NASDAQ:KALA) announced on December 17, 2021, the grant of non-statutory stock options to four new employees, totaling 13,500 shares. The options were issued as inducement awards outside the 2017 Equity Incentive Plan and have an exercise price of $1.44 per share, reflecting the stock's closing price on the grant date. Options will vest over four years, with 25% vesting after the first year and the rest in monthly installments, contingent on continued employment.
Kala Pharmaceuticals announced the granting of non-statutory stock options to new employees as inducement awards under Nasdaq Listing Rule 5635(c)(4). A total of 131,500 shares were granted to three new employees following the acquisition of Combangio, including 100,000 shares to Darius Kharabi, the new Chief Business Officer. The options have an exercise price of $2.10 per share and a ten-year term, with vesting over four years. These steps align with the company’s ongoing focus on innovative therapies for eye diseases.
Kala Pharmaceuticals reported $3.1 million in net revenue for Q3 2021, up from a year earlier, with EYSUVIS prescriptions rising by 19% compared to Q2 2021. The company has expanded its pipeline through the acquisition of Combangio, focusing on KPI-012, for treating rare ocular surface diseases. However, the net loss for Q3 2021 was $28.1 million or $0.43 per share, slightly higher than the $27.9 million loss in Q3 2020. The financial outlook expects operational funding through Q2 2023, considering ongoing revenue generation and cost containment strategies.
Kala Pharmaceuticals has acquired Combangio, a clinical-stage company, to enhance its pipeline for severe ocular surface diseases. The acquisition includes KPI-012, a promising therapy for persistent corneal epithelial defect (PCED). The Phase 1b trial showed positive results, with six out of eight patients achieving complete healing. Kala plans to submit an IND application to the FDA and initiate a Phase 2/3 trial in 3Q 2022. Mark S. Blumenkranz joins Kala's Board of Directors as part of this strategic move, expected to strengthen its offerings in eye health.
Kala Pharmaceuticals (NASDAQ:KALA) has rescheduled its financial results conference call to report Q3 2021 results on November 15 at 10:30 AM ET. The call will provide a business update, with access available via dial-in or a live webcast on the company's investor site. Kala focuses on innovative therapies for eye diseases, featuring products like EYSUVIS and INVELTYS, utilizing the AMPPLIFY Drug Delivery Technology. For further details, visit their website.
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) has announced its participation in two upcoming virtual healthcare investor conferences in November 2021. The Jefferies London Healthcare Conference will feature a pre-recorded fireside chat available on November 18, 2021, starting at 3:00 am ET. Additionally, management will engage in a virtual fireside chat at Ophthalmology Day at BTIG on November 30, 2021, at 10:00 am ET. Kala is known for its innovative therapies for eye diseases, including EYSUVIS® and INVELTYS®. For more details, visit kalarx.com.
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) will report its third quarter 2021 financial results on November 15, 2021. A conference call is scheduled for 8:30 a.m. ET to discuss these results and provide a business update. The company focuses on developing innovative therapies for eye diseases using its AMPPLIFY® mucus-penetrating particle Drug Delivery Technology. Its key products include EYSUVIS® for dry eye disease and INVELTYS® for post-operative inflammation following ocular surgery. Further details and the live webcast are available on Kala's website.
Kala Pharmaceuticals (NASDAQ: KALA) announced the grant of non-statutory stock options to ten new employees as inducement awards apart from its 2017 Equity Incentive Plan, complying with NASDAQ Listing Rule 5635(c)(4). The options, totaling 70,000 shares, were granted on October 18, 2021, with an exercise price of $1.85 per share. The options have a ten-year term and vest over four years, with 25% vesting after the first year. This move aims to attract and retain talent while aligning employee incentives with shareholder interests.
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