KALA BIO : Corporate Overview - June 2024

Innovation in Ophthalmology

Corporate Overview June 2024

NOT FOR PROMOTIONAL USE

NOT FOR PROMOTIONAL USE

Disclaimers and Notices

This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. Any statements in this presentation about KALA's future expectations, plans and prospects, including but not limited to KALA's expectations with respect to potential advantages of KPI-012 and its MSC-S platform; anticipated timelines to report topline data for the CHASE Phase 2b clinical trial of KPI-012; the design of the CHASE Phase 2b clinical trial; KALA's belief that the Chase Phase 2b trial could serve as the first of two pivotal trials required to support the submission of a BLA to the FDA; the clinical utility of KPI-012 for PCED; KALA's plans to pursue research and development of KPI-012 and its MSC-S platform for other indications; KALA's ability to realize potential milestones payments under the transaction with Alcon and the risk that KALA may not realize the expected benefits of the transaction; the sufficiency of KALA's existing cash resources and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "likely," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," "would," and similar expressions constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: KALA's ability to comply with the requirements under the CIRM award; uncertainties inherent in the initiation and conduct of preclinical studies and clinical trials; uncertainties regarding availability and timing of data from clinical trials; whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials; whether results of the Phase 1b clinical trial of KPI-012 will be indicative of results for any future clinical trials and studies of KPI-012, including the CHASE Phase 2b clinical trial; whether interim data from a clinical trial will be predictive of the results of the trial; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; KALA's ability to retain and hire key personnel; the impact of extraordinary external events, such as the pandemic health event resulting from the coronavirus (COVID-19), and their collateral consequences; the sufficiency of cash resources and need for additional financing and other important factors, any of which could cause KALA's actual results to differ from those contained in the forward- looking statements, discussed in the "Risk Factors" section of KALA's Annual Report on Form 10-K, most recently filed Quarterly Report on Form 10-Q and other filings KALA makes with the Securities and Exchange Commission.

All information in this presentation is as of June 5, 2024 and should not be considered current after such date. KALA does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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KALA BIO Clinical Readout Year End 2024 in High Value PCED Market

Late-Stage Lead Program with "Pipeline-in-a- Product" Potential

Meaningful

Upcoming

Milestones

Strong

Corporate

Position

• MSC-SPlatform enables products for multiple potential orphan indications
• Lead MSC-S Product KPI-012 is "Pipeline in a Product" for Rare Ocular Surface Diseases
• • Enrolling patients in CHASE (Corneal Healing After SEcretome therapy) Phase 2b for Persistent Corneal Epithelial Defect (PCED), a potential $1B+ market opportunity in the US alone
  • Evaluating program for limbal stem cell deficiency (LSCD) & other rare corneal diseases
• KPI-014 - MSC-Spre-clinical program for rare inherited retinal diseases
• 4Q 2022: KPI-012 PCED IND filed and accepted ü
• 2Q 2023: CHASE Phase 2b trial in PCED cohort 2 (randomized, double-masked efficacy

portion of trial) initiated ü

• YE 2024: CHASE Phase 2b top-line data in PCED - CHASE could serve as the first of two pivotal trials to support the submission of a Biologics License Agreement (BLA) to the FDA
• Experienced team: Developed & secured FDA approval for two ophthalmology products, EYSUVIS for dry eye disease and INVELTYS for post ocular surgery - Acquired by Alcon
• April 2023: Announced award by California Institute for Regenerative Medicine (CIRM) to support ongoing KPI-012 program for the treatment of PCED
• Cash, equivalents and investments of $48.5 million as of 3/31/24
• Projected cash runway into Q3 2025 including anticipated remaining funding from CIRM grant
• Outstanding shares as of 3/31/24 include 2,816,454 common and preferred shares convertible into 6,507,500 common shares.

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Leadership Team with Extensive

Ophthalmology Innovation Experience

TODD BAZEMORE	KIM BRAZZELL, PhD
President and	Head of R&D and
Chief Operating Officer	Chief Medical Officer

MARK IWICKI

Chair and

Chief Executive Officer

DARIUS KHARABI	MARY REUMUTH, CPA
Chief Business Officer	Chief Financial Officer

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KALA BIO is Advancing an Innovative Pipeline Based on Its

Proprietary Mesenchymal Stem Cell Secretome (MSC-S) Platform for the Treatment of Rare Front and Back of the Eye Diseases

Product Candidate*

Indication

Route of

Administration

Pre-

Clinical

Phase 1

Phase 2

Phase 3

	Persistent Corneal	Topical
	Epithelial Defect (PCED)
KPI-012 for Rare
Limbal Stem Cell
Ocular Surface	Topical
Deficiency (LSCD)
Disease

	Other rare corneal	Topical
	diseases
KPI-014 Program		Intravitreal
for Rare Inherited
	Injection
Retinal Disease

• * Product candidates are investigational and have not been approved by any regulatory authority.

NOT FOR PROMOTIONAL USE

KALA BIO is a Leader in the Emerging Field of

Mesenchymal Stem Cell Secretome (MSC-S) Therapy

Proprietary MSC-S Platform is a Cell-Free, Regenerative Approach to Disease Management

• Secretomes produced by collecting the biomolecules that are secreted by cells into the extracellular space to support their health and viability
• Offer many of the benefits of cell therapy without administering cells
• Avoids many of the safety and logistic concerns associated with current cell therapy approaches
• KALA MSC-S GMP manufactured from proprietary cell bank and well-defined CMC process, enabling consistent lot-to-lot safety, stability and biopotency

Secretomes Have Shown Benefits in	MSC-S Mechanisms of
Ocular Diseases, Including:	Action Include:
- Corneal injury	- Wound Healing/Tissue Repair
- Retinal degeneration	- Anti-inflammatory/Immunomodulatory
- Glaucoma	- Neurotrophic/Neuroprotective
- Dry eye disease

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MSC-S Has Potential Applications in Multiple

Rare Ocular Disease Segments

								Approximate US Prevalence
	Persistent Corneal															100,000
	Epithelial Defect (PCED)
	Limbal Stem Cell															100,000
	Deficiency
	Sjögren's														95,000
	(Moderate-to-Severe)
Anterior	Corneal Ulcers														50,000
Segment
Corneal Burns														36,000
	(Chemical Injury)
	Ocular Chronic Graft														3,000
	v. Host Disease
	Stevens-Johnson														1,000
	Syndrome
															95,000
	Retinitis Pigmentosa
															37,000
Posterior	Stargardt Disease
Segment	Non-arteric Anterior													28,000
	Ischemic Optic Neuropathy
	Leber's Hereditary													9,000
	Optic Neuropathy
	0		20,000	40,000	60,000	80,000	100,000

KPI-012

Ph 2b Program

KPI-012 Clinical

Development

Under Evaluation

• Sources: ClearView Analysis; PEDMarketInsights, Epidemiology, and Market Forecast-2030 Delveinsight, 2020; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4498999/. Accessed4Feb2021.

KPI-012 -

Regenerative

Therapy for

Rare Ocular

Surface Diseases

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NOT FOR PROMOTIONAL USE

KPI-012 - Human Bone Marrow-DerivedMSC-S

Therapy in Development for Persistent Corneal Epithelial Defect (PCED)

KPI-012Cell-Free

Regenerative

Therapy

• Composed of biomolecules produced by human bone marrow-derived MSCs and formulated into topical ocular non-preserved single dose unit formulation
• • The simple convenient topical formulation should improve patient experience
• Contains key classes of biomolecules associated with corneal wound healing including growth factors, protease inhibitors and matrix proteins; provides multifactorial approach to addressing impaired corneal healing
• Currently in development for PCED with the goal of complete healing of the PCED
• • Multifactorial mechanism of action could address all underlying etiologies of
    PCED
• Orphan Drug and Fast Track Designations granted by FDA

KPI-012 Has the Potential to Treat Multiple Rare Corneal Diseases

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KPI-012 in Phase 2b for PCED

• PCED - persistent non-healing corneal defect that is refractory to conventional treatments
• Significant symptoms (e.g., pain, photophobia, visual impairment)
• If not healed, can lead to infection, stromal thinning/scarring, corneal perforation and vision loss
• Can be caused by a number of underlying etiologies including: trauma, neurotrophic keratitis, diabetic keratopathy, severe ocular surface disease, microbial/viral keratitis, corneal transplant/other ocular surgeries
• • Patients often have more than one underlying etiology
• Estimated incidence of approximately 100,000 patients in the US and 238,000 in the US, EU and Japan combined
• In Ph 1b clinical trial, KPI-012 produced clinical improvement in all 8 treated PCED patients with complete healing of the PCED in 6 of 8

PCED is an Underserved Market:

• There are currently no FDA-approved Rx products with a broad PCED indication for all underlying etiologies
• Oxervate® (nerve growth factor) has limited indication for Neurotrophic Keratitis (~1/3 PCED cases) and is complex and burdensome for patients to administer.

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