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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38150 KALA BIO, Inc. (Exact name of registrant as specified in its charter) Delaware 27-0604595 (State or other jurisdict ...

Financial Performance - KALA reported a net loss of $11.8 million, or $4.20 per share, for Q1 2024, compared to a net loss of $14.5 million, or $6.99 per share, for the same period in 2023[11]. - General and administrative expenses for Q1 2024 were $5.4 million, a decrease from $6.0 million in Q1 2023, primarily due to lower administrative and professional service fees[11]. - Research and development expenses for Q1 2024 increased to $6.4 million from $4.0 million in Q1 2023, driven by higher development costs for KPI-012[11]. - KALA's total assets as of March 31, 2024, were $53.0 million, down from $55.9 million as of December 31, 2023[15]. - As of March 31, 2024, KALA had cash and cash equivalents of $48.5 million, down from $50.9 million as of December 31, 2023, reflecting cash used in operations[8]. Product Development and Market Opportunity - KALA is targeting topline data from the ongoing Phase 2b CHASE trial of KPI-012 for persistent corneal epithelial defect (PCED) by year-end 2024, which could support a Biologics License Application (BLA) submission[2]. - The estimated incidence of PCED in the U.S. is approximately 100,000 patients, representing a significant market opportunity as there are currently no FDA-approved products for all underlying etiologies of PCED[5]. - KALA is exploring the potential of KPI-012 for additional rare corneal diseases, including Limbal Stem Cell Deficiency (LSCD), which also has an estimated incidence of 100,000 patients in the U.S.[6]. - KPI-014, KALA's preclinical program, is being evaluated for inherited retinal degenerative diseases, with preclinical studies initiated for conditions such as Retinitis Pigmentosa and Stargardt Disease[7]. Future Outlook - The company anticipates that its cash resources will fund operations into the third quarter of 2025, supported by anticipated funding from the CIRM award[8].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38150 KALA BIO, Inc. (Exact name of registrant as specified in its charter) Delaware 27-0604595 (State or other jurisdiction o ...

ARLINGTON, Mass., March 29, 2024 – 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 reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a corporate update. "In 2023, we focused on clinical execution, advancing our Phase 2b CHASE trial of KPI-012 for the treatment of PCED. In March 2023, we announced positi ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38150 KALA BIO, Inc. (Exact name of registrant as specified in its charter) Delaware 27-0604595 (State or other juris ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38150 KALA BIO, Inc. (Exact name of registrant as specified in its charter) Delaware 27-0604595 (State or other jurisdicti ...