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Kala Bio Engages Dr. Saeid Babaei as Senior Scientific Advisor to Evaluate Clinical Assets and Precision Development Opportunities

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Kala Bio (NASDAQ: KALA) engaged Dr. Saeid Babaei as Senior Scientific Advisor on April 1, 2026 to evaluate clinical and molecular assets, including its MSC Secretome platform, using AI-enabled analytics, digital health tools, and secure data integration to assess responder hypotheses and amended indication opportunities.

The initial work will review Phase 2 datasets, trial protocols, and translational hypotheses to inform development, partnering, licensing, or commercialization pathways.

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Positive

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Negative

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News Market Reaction – KALA

-5.83%
11 alerts
-5.83% Session close to close
+13.0% Peak Tracked
-21.1% Trough Tracked
$157.75M Market Cap
0.3x Rel. Volume

In the Apr 1 session, KALA declined 5.83%, reflecting a notable negative market reaction. Argus tracked a peak move of +13.0% during that session. Argus tracked a trough of -21.1% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -5.8% in the session following this news. A negative reaction despite the advisory e...
Analysis

The stock moved -5.8% in the session following this news. A negative reaction despite the advisory engagement would fit a pattern where some positive AI-related updates have seen selling pressure, as on March 4 and March 30. The company still carries a preliminary 2025 net loss of $27.3 million and a substantial share overhang from 241,435,910 registered resale shares. With the stock trading well below its 200-day MA of 3.83, investors may focus on balance-sheet and dilution risks alongside strategic news.

Key Figures

2025 net loss: $27.3 million 2024 net loss: $38.5 million Debt settled: $10.6 million +5 more
8 metrics
2025 net loss $27.3 million Preliminary result for year ended December 31, 2025 (NT 10-K)
2024 net loss $38.5 million Prior-year result for 2024 (NT 10-K comparison)
Debt settled $10.6 million Loan settlement with Oxford Finance completed as of December 26, 2025
Settlement payment $2.0 million Cash payment under November 25, 2025 Loan Settlement Agreement
Shares registered 241,435,910 shares Common stock registered for resale in 424B3/S-3 filings
Shares outstanding 911,330,225 shares Common shares outstanding as of February 4, 2026
MSC market 2026 USD 5.1 billion Projected mesenchymal stem cell market size in 2026 from article
MSC market 2031 USD 9.1 billion Projected mesenchymal stem cell market size in 2031 from article

Historical Context

5 past events · Latest: Mar 30 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Mar 30 AI agent launch Positive -2.7% Commercial launch of Bionic Intelligence Research Agent via Researgency.ai platform.
Mar 18 AI platform deal Positive +0.2% Researgency.ai engaged to support clinical development of psilocybin candidate PEX010.
Mar 11 AI strategy launch Positive +24.2% Rebrand and launch of Researgency.ai with first commercial agent expected in 14 days.
Mar 04 AI infra initiative Positive -1.5% Strategic move to deploy on‑premises AI platform under exclusive Researgency license.
Jan 05 Debt settlement Positive +6.9% Settlement of about $10.6M of debt with Oxford Finance, removing a capital structure overhang.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent AI and strategic updates have seen mixed reactions, with some positive announcements sold off and others drawing sharp rallies.

Recent Company History

Over the last few months, KALA has shifted toward a dual-engine strategy, combining its MSC-S and KPI-012 programs with the Researgency.ai platform. Key AI initiatives on March 4, March 11, and March 30 focused on on‑premises infrastructure, rapid agent deployment, and launch of the BIRA research agent, producing both gains and pullbacks. A $10.6 million debt settlement on January 5 helped clean up the balance sheet. Today’s announcement extends that AI focus into reassessing clinical assets and the MSC secretome platform.

Key Terms

msc secretome, ai-enabled analytics, responder subgroups, biomarkers, +4 more
8 terms
msc secretome medical
"including the MSC Secretome platformTORONTO, April 01, 2026 -- Kala Bio Inc."
MSC secretome is the collection of molecules and tiny particles released by mesenchymal stem/stromal cells, including growth proteins, signaling molecules and membrane-bound vesicles, that together drive healing and immune effects without transplanting whole cells. Investors track it because companies are developing off-the-shelf therapies and diagnostic products based on these secreted factors; like buying the recipe instead of the baker, the secretome can offer easier manufacturing, clearer safety profiles and distinct regulatory and commercial pathways than live‑cell treatments.
ai-enabled analytics technical
"through the potential application of AI-enabled analytics, digital health tools, and secure"
AI-enabled analytics are computer tools that use artificial intelligence to sift through large amounts of data, spot patterns, make predictions and present insights in a clear way—like a smart assistant that quickly sorts and highlights the most important items in a crowded inbox. For investors this matters because it can speed decision-making, reveal risks or opportunities that humans might miss, and potentially improve forecasting, efficiency and competitive advantage.
responder subgroups medical
"assessing hypotheses related to potential responder subgroups, and contributing scientific input"
Responder subgroups are specific sets of patients within a clinical trial who show a measurable positive reaction to a treatment, like a certain symptom improving or a biomarker changing. For investors, identifying these groups is important because it reveals whether a therapy works reliably for particular types of patients, which affects potential market size, pricing power, regulatory approval chances, and partnership or licensing value—similar to discovering which customer segment prefers a product before scaling it.
biomarkers medical
"data, biological samples, biomarkers, outcomes, and operational metadata that often remain"
Biomarkers are measurable indicators found in the body, such as substances in blood or tissues, that reveal information about health or disease. For investors, they can signal how well a medical treatment is working or whether a disease is developing, helping to assess the potential success or risks of healthcare companies or innovations. Think of biomarkers as biological signals that provide clues about a person’s health status.
secretome medical
"The secretome, the collection of bioactive molecules and extracellular vesicles secreted"
The secretome is the collection of molecules—mainly proteins and signaling factors—that a cell or tissue releases into its surroundings, like the mail a cell sends out to communicate and influence other cells. For investors, the secretome matters because these released molecules can become diagnostic biomarkers, drug targets, or therapeutic products; companies that can identify, measure, or modulate secretome components may create new tests, treatments, or revenue streams.
mesenchymal stem cells medical
"extracellular vesicles secreted by mesenchymal stem cells, represents one of the most rapidly"
Mesenchymal stem cells are adult cells that can develop into bone, cartilage, fat and other connective tissues and act like a versatile repair crew in the body. Investors watch them because they are the basis for many experimental therapies and regenerative medicines: successful clinical results could create large markets, while manufacturing complexity, safety concerns and regulatory hurdles make development costly and risky.
extracellular vesicles medical
"the collection of bioactive molecules and extracellular vesicles secreted by mesenchymal"
Extracellular vesicles are tiny, cell-made particles—think microscopic bubbles—that carry proteins, genetic material and signals between cells. Investors care because these vesicles can be used as disease markers, drug-delivery vehicles, or therapeutic products; that creates opportunities and risks around clinical validation, manufacturing scale-up, intellectual property and regulatory approval that can materially affect the value of biotech and diagnostics companies.
compound annual growth rate financial
"to USD 9.1 billion by 2031, reflecting a compound annual growth rate exceeding 12%."
The compound annual growth rate (CAGR) shows how much an investment or value has grown, on average, each year over a specific period. It considers the effect of growth that compounds or builds upon itself, similar to how interest accumulates in a savings account. Investors use CAGR to compare different investments’ long-term performance and to understand how steady or consistent their growth has been over time.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Engagement will assess KALA’s clinical assets, development options, and AI-enabled analytical opportunities, including the MSC Secretome platform

TORONTO, April 01, 2026 (GLOBE NEWSWIRE) -- Kala Bio Inc. (NASDAQ: KALA), a clinical-stage biopharmaceutical company at the forefront of artificial intelligence and cell and gene therapy innovation, today announced the engagement of Dr. Saeid Babaei, PhD, MBA, as Senior Scientific Advisor.

Dr. Babaei’s engagement will focus on advising on the evaluation of Kala’s clinical and molecular assets, including the proprietary MSC Secretome platform, through the potential application of AI-enabled analytics, digital health tools, and secure data integration approaches. His mandate includes advising on clinical development considerations, assessing hypotheses related to potential responder subgroups, and contributing scientific input to the development of a responsible, regulatory-conscious analytical framework for enterprise-scale biotech applications.

Strategic Context: Unlocking Value Through Amended Indications

This collaboration marks a pivotal step in Kala Bio's strategy to maximize the commercial and scientific value of its existing clinical assets through innovation and precision analytics. The initial phase will include a review of historical datasets, trial protocols, and translational hypotheses to help inform strategic considerations for future development and potential partnering, licensing, or commercialization pathways.

“We will be undertaking a rigorous review of our data to evaluate whether amended indications or revised development strategies may merit further consideration. There are many examples in biopharma where a refined indication strategy has created significant value, and we believe our Phase 2 dataset warrants a disciplined reassessment,” said Avi Minkowitz, Chief Executive Officer of Kala Bio.

AI-Enabled Research and Market Opportunity

Clinical trials generate vast volumes of data, biological samples, biomarkers, outcomes, and operational metadata that often remain underutilized after primary endpoints are reported. Kala Bio’s structured re-analysis, supported by AI and machine learning tools, is intended to explore whether clinically relevant patterns or potential responder hypotheses may be identified to inform future therapeutic development decisions.

A central focus of this engagement is evaluating Kala's work in the MSC secretome space. The secretome, the collection of bioactive molecules and extracellular vesicles secreted by mesenchymal stem cells, represents one of the most rapidly advancing frontiers in regenerative biologics and cell and gene therapies. Industry analysts project the mesenchymal stem cell market to grow from approximately USD 5.1 billion in 2026 to USD 9.1 billion by 2031, reflecting a compound annual growth rate exceeding 12%. Secretome-derived therapies and extracellular vesicle platforms represent a significant component of that expansion.

Dr. Babaei’s assessment will help evaluate the scientific and potential commercial relevance of Kala’s secretome platform and consider possible pathways for future development, partnering, licensing, or strategic collaboration.

“We are pleased to engage Dr. Babaei as a top scientific partner in this critical phase of Kala's evolution,” said Avi Minkowitz, Chief Executive Officer of Kala Bio. “His experience contributing to clinical research and development programs across oncology, genomics, and biologics brings a valuable scientific and strategic perspective at this stage. Our focus is to rigorously analyze these assets and determine whether there may be a structured path forward, including possible development, partnering, commercialization, or licensing opportunities.”

“KALA Bio has assembled a meaningful scientific dataset that warrants a careful and structured reassessment,” commented Dr. Babaei. “My focus is to evaluate where the underlying evidence may support new insight, help shape a more informed future development strategy, and enable the responsible application of AI-enabled analysis, including an objective assessment of the scientific merits and potential strategic relevance of KALA’s secretome platform.”

About Dr. Saeid Babaei

Dr. Saeid Babaei, PhD, MBA, is a serial biotech entrepreneur and executive leader with over 28 years of experience founding, financing, and scaling healthcare and life science companies across genomics, diagnostics, and oncology. He has overseen more than 25 strategic transactions, raised over $50 million, and contributed to multiple clinical research and development programs spanning oncology, genomics, and biologics. Dr. Babaei currently serves as Chairman and CEO of Virotek Biosciences and Managing Director of Ameretat Investment. He is also a Professor of Entrepreneurship and Innovation at the Schulich School of Business, York University.

For Dr. Babaei's full professional profile, visit: linkedin.com/in/saeid-babaei-aa7a19

About Researgency.ai

Researgency.ai is an agentic, on-premises AI platform developed by Kala Bio in collaboration with Younet. Designed for secure, scalable deployment in regulatory-compliant biopharmaceutical environments, Researgency.ai enables biotech companies to turn clinical and molecular data into actionable insights for therapeutic optimization, digital health integration, and commercialization.

ABOUT KALA BIO (NASDAQ: KALA)

KALA BIO, Inc. is a clinical-stage biopharmaceutical company building a dedicated, on-premises AI infrastructure platform for the biotechnology industry. The Company's dual strategy combines a proprietary biologics pipeline—including its mesenchymal stem cell secretome (MSC-S) platform and FDA Orphan Drug- and Fast Track-designated product candidates—with a scalable AI platform-as-a-service business designed to deploy secure, purpose-built AI solutions directly within biotech and pharmaceutical client environments.

Through its exclusive worldwide license for the Researgency AI research platform from Younet, Kala intends to serve as the dedicated AI infrastructure partner for the biotechnology industry, enabling organizations of all sizes to unlock the value of their proprietary biological data without surrendering control. Kala is advancing an agentic transformation strategy for biomedical organizations through Researgency.ai, a platform designed to enable scalable, governed deployment of AI agents across research, documentation, and operational workflows. The Company's focus on enterprise security, real-time performance, and seamless integration positions it at the forefront of innovation in the life sciences AI sector.

Kala believes the future of biomedical innovation is in agentic systems.

For more information, visit www.kalarx.com and www.Researgency.ai

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's strategic initiative to build an AI infrastructure platform for the biotechnology industry, plans to develop and deploy the Researgency AI platform both internally and to external clients, expectations regarding the potential benefits of AI-driven analytical tools, plans to reassess historical datasets and identify new therapeutic indications, expectations regarding the AI drug discovery market and industry trends, expectations regarding the Company's ability to generate recurring platform revenue, plans regarding potential partnerships, client deployments, or technology licensing opportunities, expectations regarding the Company's competitive position and the differentiation of its on-premises deployment model, the potential exercise of development continuation or renewal options under the Agreement, and other statements that are not historical facts.

The Company used words like "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions to identify these forward-looking statements. These statements involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance, or achievements to be materially different from those expressed or implied by such statements. Important factors that could cause such differences include, but are not limited to: risks that AI technologies may not produce expected results in drug discovery or development; risks related to the development, deployment, and performance of the Researgency platform; risks that the Company may not successfully attract or retain external platform clients; risks that the platform-as-a-service business model may not generate anticipated revenues; risks that the Company's product candidates may not be successfully developed or commercialized; risks related to the Company's limited cash resources and ability to continue as a going concern; risks that the third-party information contained herein was not accurate at the time it was published and/or does not accurately predict the future; risks related to the Company's ability to raise future capital and the possibility that market conditions may limit the Company's ability to raise capital on favorable terms; risks related to the Company's ability to regain compliance with Nasdaq listing requirements; competition from larger, better-resourced companies including major technology and pharmaceutical companies; dependence on key personnel and third-party technology providers; the accuracy of third-party market forecasts and projections cited herein; risks that the Company may elect not to expand or continue its deployment of the Researgency platform beyond the initial term; risks that Younet may not perform its obligations under the Agreement; and other risks detailed in the "Risk Factors" section of the Company's Annual Report on Form 10-K as they may be revised in the Company's Quarterly Reports on Form 10-Q and Current Reports on Form 8-K and other filings with the Securities and Exchange Commission.

Forward-looking statements speak only as of the date of this release, and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Contact:

Avi Minkowitz
Chief Executive Officer, KALA BIO, Inc.
am@kalarx.com
www.kalarx.com | www.Researgency.ai


FAQ

What will Dr. Saeid Babaei evaluate for Kala Bio (KALA) after his April 1, 2026 engagement?

Dr. Babaei will assess Kala Bio's clinical and molecular assets, focusing on the MSC Secretome platform and Phase 2 datasets. According to Kala Bio, his role includes applying AI-enabled analytics, reviewing trial protocols, and advising on responder subgroup hypotheses to inform development options.

How could Kala Bio (KALA) use AI in reassessing its Phase 2 data?

Kala Bio plans structured re-analysis using AI and machine learning to identify clinically relevant patterns or responder hypotheses. According to Kala Bio, this approach aims to mine biomarkers, outcomes, and operational metadata to inform amended indications or future development strategies.

What is the immediate strategic goal of Kala Bio (KALA) engaging a senior scientific advisor?

The immediate goal is to determine whether amended indications or revised development strategies merit further consideration. According to Kala Bio, the advisor will rigorously review historical datasets and translational hypotheses to guide potential partnering, licensing, or commercialization decisions.

Will Dr. Babaei's work on KALA's MSC secretome affect partnering or licensing plans?

Dr. Babaei's assessment may inform potential partnering, licensing, or commercialization pathways for the MSC secretome platform. According to Kala Bio, his scientific and strategic input will evaluate commercial relevance and possible development or collaboration routes based on the data review.

What aspects of Kala Bio's (KALA) MSC secretome will be reviewed during the engagement?

The review will cover scientific merits, translational hypotheses, and commercial relevance of the MSC secretome platform. According to Kala Bio, the assessment includes biomarker patterns, extracellular vesicle data, and whether evidence supports targeted responder subgroup strategies.

Does Kala Bio (KALA) expect this advisory review to change its development plans or indications?

Kala Bio is undertaking a disciplined reassessment to evaluate whether amended indications or revised strategies warrant further pursuit. According to Kala Bio, the review of Phase 2 data and protocols will inform any structured path forward, including development, partnering, or commercialization.