Company Overview - KALA BIO, Inc. is a clinical-stage biopharmaceutical company focused on innovative therapies for rare and severe eye diseases [3] - The company utilizes a proprietary mesenchymal stem cell secretome (MSC-S) platform for its investigational therapies [3] Product Development - KALA's lead product candidate, KPI-012, is designed to address impaired corneal healing, specifically for persistent corneal epithelial defect (PCED) [3] - KPI-012 has received Orphan Drug and Fast Track designations from the U.S. FDA, indicating its potential significance in treating rare diseases [3] - The company is also exploring KPI-012 for Limbal Stem Cell Deficiency and other rare corneal diseases that threaten vision [3] - Preclinical studies are underway to evaluate the MSC-S platform's potential for treating retinal degenerative diseases, including Retinitis Pigmentosa and Stargardt Disease [3] Upcoming Events - KALA management will present at the TD Cowen 45th Annual Health Care Conference on March 5, 2025, at 11:50 a.m. ET [1] - One-on-one meetings with management will also be available on the same day [1]

Core Viewpoint - KALA BIO, Inc. announces the resignation of CEO Mark Iwicki and the appointment of Todd Bazemore as interim CEO, effective immediately, while Iwicki will remain as Chair of the Board [1][2] Company Overview - KALA BIO, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for rare and severe eye diseases [3] - The company utilizes its proprietary mesenchymal stem cell secretome (MSC-S) platform for its investigational therapies [3] Leadership Transition - Mark Iwicki has been with KALA and is proud of the work done utilizing the MSC-S platform, particularly regarding the lead product candidate KPI-012 for treating persistent corneal epithelial defect (PCED) [2] - Todd Bazemore, who has over 30 years of experience in the pharmaceutical industry, has been with KALA since November 2017 and will lead the company during this transition [2][3] Product Development - KALA's lead product candidate, KPI-012, is in clinical development for PCED and has received Orphan Drug and Fast Track designations from the U.S. FDA [3] - The company is also exploring the potential of KPI-012 for Limbal Stem Cell Deficiency and other rare corneal diseases, as well as preclinical studies for retinal degenerative diseases [3]

Company Overview - KALA BIO, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for rare and severe eye diseases [10] - The company's lead product candidate, KPI-012, is designed to treat persistent corneal epithelial defect (PCED) and has received Orphan Drug and Fast Track designations from the U.S. FDA [10] Private Placement Details - KALA has entered into a securities purchase agreement for a private placement, raising approximately $10.75 million before expenses [1] - The company will sell 1,340,603 shares of common stock at $6.44 per share and 3,286 shares of Series I Preferred Stock at $644.00 per share [2] - The private placement is expected to close on or about December 31, 2024, pending customary closing conditions [2] Use of Proceeds - The net proceeds from the private placement will be used to advance the clinical development of KPI-012 and for general corporate purposes [8] - KALA anticipates that the funds will support operations into the first quarter of 2026 [8] Clinical Development and Trials - KALA is actively recruiting patients for the ongoing Phase 2b CHASE trial of KPI-012, with over 40 clinical trial sites open and enrolling [8] - The company expects to report topline data from the CHASE trial in the second quarter of 2025, which may serve as the first of two pivotal trials required for a Biologics License Application (BLA) submission [8] Investor Participation - The private placement included participation from both new and existing investors, such as SR One, Cormorant Asset Management, and Woodline Partners [7]

Core Viewpoint - KALA BIO has experienced a bearish trend recently, losing 9% over the past week, but the formation of a hammer chart pattern suggests a potential trend reversal as buying interest may be increasing [1] Technical Analysis - The hammer chart pattern indicates a possible bottom formation, suggesting that selling pressure may be subsiding [1] - A hammer pattern occurs during a downtrend when the stock opens lower, makes a new low, but then closes near or above the opening price, signaling a potential loss of control by bears [2] - Hammer candles can appear on various timeframes and should be used alongside other bullish indicators for confirmation [2] Fundamental Analysis - KALA has seen an upward trend in earnings estimate revisions, with a 1.5% increase in the consensus EPS estimate over the last 30 days, indicating analysts expect better earnings than previously predicted [3] - The company holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [3] - The Zacks Rank serves as a timing indicator, suggesting that KALA's prospects are improving, reinforcing the potential for a turnaround [3]

Company Overview - KALA BIO, Inc. is a clinical-stage biopharmaceutical company focused on innovative therapies for rare and severe eye diseases [3] - The company utilizes a proprietary mesenchymal stem cell secretome (MSC-S) platform for its biologics-based investigational therapies [3] Product Development - KALA's lead product candidate, KPI-012, is designed to address persistent corneal epithelial defect (PCED), a rare disease linked to impaired corneal healing [3] - KPI-012 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration [3] - The company is also exploring KPI-012 for Limbal Stem Cell Deficiency and other rare corneal diseases that threaten vision [3] - Preclinical studies are underway to evaluate the MSC-S platform's potential for treating retinal degenerative diseases, including Retinitis Pigmentosa and Stargardt Disease [3] Upcoming Events - Kim Brazzell, Ph.D., Head of R&D and Chief Medical Officer, will present at the Piper Sandler 36th Annual Healthcare Conference on December 4, 2024 [1] - Management will be available for one-on-one meetings on the same day [1]

Core Viewpoint - KALA BIO has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which have a strong correlation with near-term stock price movements [4][6]. - For KALA BIO, the recent upgrade reflects an improvement in the company's underlying business, likely leading to increased stock prices due to investor interest [5][10]. Earnings Estimate Revisions - KALA BIO is expected to earn -$11.76 per share for the fiscal year ending December 2024, representing a 32.2% change from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for KALA BIO has increased by 18.9%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - KALA BIO's upgrade to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Shares of KALA BIO (KALA) have been struggling lately and have lost 17.1% over the past four weeks. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road. The formation of a hammer pattern is considered a technical indication of nearing a bottom with likely subsiding of selling pressure. But this is not the only factor that makes a bullish case fo ...

Clinical Development - KPI-012 is currently in Phase 2b clinical development for the treatment of persistent corneal epithelial defects (PCED), with topline safety and efficacy data expected in Q1 2025[99]. - The CHASE trial has opened approximately 35 to 40 trial sites in the U.S. and is in the process of initiating sites in Latin America, pending regulatory approval[98]. - The company has ceased development of preclinical pipeline programs unrelated to its MSC-S platform to focus resources on KPI-012[100]. - The company anticipates substantial increases in research and development expenses as it advances the clinical development of KPI-012 and other product candidates[164]. Financial Performance - The company reported a net loss of $9.6 million and $21.4 million for the three and six months ended June 30, 2024, respectively, and an accumulated deficit of $650.8 million as of June 30, 2024[104]. - For the three months ended June 30, 2024, total operating expenses were $9.6 million, slightly up from $9.6 million in the same period of 2023[124]. - The net loss for the three months ended June 30, 2024, was $9.6 million, an improvement of $0.8 million compared to a net loss of $10.4 million in the same period of 2023[124]. - General and administrative expenses decreased to $4.3 million for the three months ended June 30, 2024, down from $5.0 million in the same period of 2023, a reduction of $0.6 million[125]. - For the six months ended June 30, 2024, research and development expenses totaled $11.7 million, an increase of $3.4 million from $8.3 million in the same period of 2023[133]. - Net cash used in operating activities for the six months ended June 30, 2024, was $20.1 million, compared to $17.3 million for the same period in 2023, reflecting an increase of $2.8 million[161]. Funding and Capital - The company has incurred significant losses from operations and negative cash flows, financing operations primarily through the sale of its Commercial Business to Alcon and various stock offerings[104]. - The company raised $75.0 million through the sale of common stock under an at-the-market offering, with 565,974 shares sold prior to the termination of the sales agreement on January 10, 2023[142]. - The company completed a private placement in December 2022, raising approximately $31.0 million through the issuance of common stock and Series E Preferred Stock[151]. - The company plans to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute ownership interests[170]. - The company may need to raise additional capital in the future to advance its business, which could adversely affect its financial condition[172]. Grants and Milestones - The company received a $15.0 million grant from CIRM to support the KPI-012 program, with an initial disbursement of $5.9 million received on August 2, 2023[118]. - Grant income for the three months ended June 30, 2024, was $1.0 million related to the CIRM Award, with no grant income recognized in the same period of 2023[130]. - Grant income for the six months ended June 30, 2024, was $2.1 million related to the CIRM Award, while no grant income was recognized in the same period of 2023[138]. - A grant of $15 million was awarded to the company by CIRM on April 28, 2023, to support the KPI-012 program, with $5.9 million disbursed in August 2023 and an additional $3.2 million expected in August 2024[154]. - The company may be required to pay up to $105.0 million in contingent milestone payments to Combangio equityholders based on the achievement of specified milestones[114]. Cash and Debt Management - As of June 30, 2024, the company had $54.2 million in cash and cash equivalents, an increase from $50.9 million as of December 31, 2023[158]. - The company expects existing cash resources to fund operations into the fourth quarter of 2025, but does not anticipate these resources will be sufficient to complete the clinical development of KPI-012[166]. - The aggregate principal amount outstanding under the Loan Agreement bore interest at a floating rate equal to the greater of 30-day LIBOR or 0.11% plus 7.89% through June 30, 2023[174]. - The interest rate on the Loan Agreement is now a floating rate with a minimum of 8.00% effective July 1, 2023[174]. - The company’s cash equivalents as of June 30, 2024 consisted of money market accounts and U.S. treasury securities with maturities of less than 90 days[173].

-- Closed $12.5 million private placement financing led by SR One with participation from ADAR1 Capital Management and another life sciences-focused investor – -- Cash resources of $54.2 million as of June 30, 2024, together with anticipated funding remaining from CIRM award, expected to fund operations into 4Q 2025 – -- Topline data from Phase 2b CHASE trial of KPI-012 for PCED targeted in Q1 2025 -- ARLINGTON, Mass., Aug. 06, 2024 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharm ...

ARLINGTON, Mass., June 27, 2024 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today announced that it has entered into a securities purchase agreement with a select group of institutional accredited investors for the sale, in a private placement, of shares of its common stock and shares of its Series H Convertible Non-Redeemable Preferre ...