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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) has appointed C. Daniel Myers to its Board of Directors as a Class III director. With over 35 years in ophthalmic pharmaceuticals, Myers will contribute to the Compensation and Nominating Committees. CEO Mark Iwicki expressed optimism about Myers' extensive background, emphasizing its potential to enhance Kala's commercial strategies, particularly for its products EYSUVIS and INVELTYS. Concurrently, Rajeev Shah will step down from the Board after significant contributions since 2015, marking a leadership transition for the company.
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) announced the granting of non-statutory stock options to eleven new employees, totaling 112,000 shares, as inducement awards compliant with NASDAQ Listing Rule 5635(c)(4). The options granted on September 15, 2021, have an exercise price of $3.08 per share, matching the closing price on that date. The awards vest over four years, with 25% vested after the first year and the remainder vesting monthly. The initiative aims to attract talent in the biopharmaceutical sector focused on innovative ocular therapies.
Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company specializing in ocular therapies, announced participation in two virtual healthcare investor conferences in September 2021. The H.C. Wainwright 23rd Annual Global Investment Conference will feature a pre-recorded presentation available from September 13 at 7:00 a.m. ET. Additionally, the Cantor Global Healthcare Conference 2021 will have a presentation starting September 28 at 4:40 p.m. ET. Both events will allow for virtual one-on-one meetings. Archived recordings will be accessible on the company's website for at least 30 days.
Kala Pharmaceuticals (NASDAQ:KALA) announced on August 18, 2021, the granting of non-statutory stock options to eight new employees as inducement awards outside its 2017 Equity Incentive Plan, in compliance with NASDAQ Listing Rule 5635(c)(4). A total of 78,000 stock options were granted at an exercise price of $3.03 per share, the closing price on the grant date. The options have a ten-year term, vesting over four years, with 25% vesting on the first anniversary and the remainder vesting monthly thereafter, contingent upon continued employment.
Kala Pharmaceuticals reported a 93% increase in EYSUVIS prescriptions in Q2 2021, totaling 15,632 prescriptions. The company achieved $3.1 million in net revenue, driven by $1.7 million from EYSUVIS and $1.4 million from INVELTYS. Coverage for EYSUVIS now extends to over 96 million lives, enhancing market access. However, the operating loss widened to $29 million, and the net loss reached $36.5 million or $0.57 per share, compared to a loss of $23.3 million in Q2 2020. Cash reserves were reported at $149.6 million.
Kala Pharmaceuticals (NASDAQ: KALA) announced its participation in two virtual healthcare investor conferences in August 2021. On August 11, COO Todd Bazemore will discuss next-generation ophthalmology treatments, focusing on dry eye and AMD at the Wedbush PacGrow Healthcare Virtual Conference. On August 17, a pre-recorded presentation will be available, followed by a panel featuring CMO Kim Brazzell discussing emerging therapeutics for dry eye disease. Access to the events can be found on the Kala website.
Kala Pharmaceuticals (NASDAQ:KALA), a biopharmaceutical firm specializing in ocular therapies, will report its second quarter 2021 financial results on August 5, 2021. The company will also host a conference call at 8:00 a.m. ET to discuss the results and provide a business update. Kala's products include EYSUVIS for dry eye disease and INVELTYS for post-operative inflammation. The company leverages its proprietary AMPPLIFY mucus-penetrating particle technology to enhance drug delivery.
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) announced the granting of non-statutory stock options to 16 new employees as inducement awards outside its 2017 Equity Incentive Plan. A total of 92,000 stock options were granted on July 15, 2021, with an exercise price of $4.01 per share, reflecting the closing price on that date. These options will vest over four years, with 25% vesting after the first year. This move is part of the company's strategy to attract and retain talent in its ongoing development of innovative ocular therapies.
Kala Pharmaceuticals (NASDAQ: KALA) announced the grant of non-statutory stock options to five new employees, totaling 64,500 shares. This award was made outside the 2017 Equity Incentive Plan in compliance with NASDAQ Listing Rule 5635(c)(4). The options, which vest over four years, were approved by the Compensation Committee and have an exercise price of $5.70 per share, reflecting the closing stock price on June 15, 2021. This move is aimed at incentivizing new hires as the company continues its focus on developing innovative therapies for eye diseases.
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) announced that OptumRx, a major pharmacy benefit manager in the U.S., has included EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% on its commercial formularies, effective May 21, 2021. This addition allows more than 88 million people with commercial health insurance access to EYSUVIS, furthering Kala's goal of widespread market access. EYSUVIS, approved by the FDA in October 2020, is the first prescription therapy specifically for short-term dry eye disease treatment. The company aims to expand payer coverage through ongoing efforts with health plans.
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