Lunai Bioworks, Inc. Issues Letter to Shareholders

PR Newswire

SACRAMENTO, Calif. , Feb. 9, 2026 /PRNewswire/ --

Dear Shareholders,

We have completed our AI platform in the last 12 months and now it is commercial. Negotiations are moving forward with several pharmaceutical and drug discovery companies. Partnerships and collaborations are imminent. Why? -because Lunai Bioworks operates a closed loop AI system that is truly disruptive (and complementary) to current discovery platforms and that turns complex biology into real-world action in several ways with less cash burn and new revenue streams. Our Augusta platform starts with real biological signals from patients — genetic, molecular, and clinical data — and uses artificial intelligence to reverse-engineer diseases into biologically defined subgroups. Instead of asking, "What drug hits this target?" Lunai asks, "What biology is actually driving this subgroup of patients?"

Then comes the part most AI companies can't do.

Lunai rapidly tests its predictions in living systems using high-throughput in vivo models. That means its drug ideas aren't just computer outputs — they're biologically validated early, before hundreds of millions of dollars are spent. Our approach is designed to shorten pharmaceutical companies' current drug discovery programs from over 2 years to under a year, same them substantial money, and increase the probability of success.

In short:

Better data ? smarter targets ? earlier proof ? lower risk.

Lunia has established three revenue driven engines

A) AI Drug Discovery: enabling pharmaceutical companies to understand disease biology and design better clinical trials, so promising therapies reach patients faster. We have established new fully owned company technologies for royalty-based partnerships.  While we have been focused on CNS diseases today, we launched a new AI oncology pilot with a clinical-stage partner using our Augusta platform to re-analyze data from a randomized Phase 2 metastatic colorectal cancer survival trial—work that can expand into a broader commercial relationship. We validated the foundation for this project in our work for Northwell Health and J&J (Janssen) using real-world hospital data from severe COVID-19 patients to show that different patient subgroups experience very different outcomes. This program demonstrated that analyzing large clinical datasets can reveal which patients are most likely to benefit from specific treatments, reinforcing the value of Lunai's precision-medicine approach.

B) AI Bio-Defense discoveries: using AI to detect emerging chemical/biological threats, understand their effects quickly, and help identify effective antidotes and countermeasures. This initiative applied our same technology stack in reverse. We already understand chemical toxicity which we use to screen out potential new drugs. For biodefense we can use our data in combination with other large data sets to identify new chemical weapons, test antidotes in our closed loop in vivo system, and can then identify countermeasures.  Our goal is to monetize this program through government contracts.

C) Immunotherapy: we reported that its next-generation allogeneic dendritic cell (DC) immunotherapy achieved complete regression of both primary and metastatic pancreatic tumors in preclinical humanized mouse models, and that these results were published in a peer-reviewed Brief Report in the journal Vaccines (Nov. 2025). We have recieved an LOI to license the therapy and are currently in discussion with several other companies for licensing other parts of our oncology platform.

Path A: AI Drug Discovery — making clinical trials smarter and more likely to succeed

Despite billions spent every year, drug development still fails more than it succeeds — especially in brain diseases like Alzheimer's, Parkinson's, alcohol use disorder, and epilepsy. The traditional model is slow, expensive, and based largely on educated guesswork. Companies pick a target, design a drug, and hope it works in humans years later. Most don't. The reason that no drugs have worked for what call Alzheimer's and Parkinsons is that the "one-size-fits-all" drugs were doomed from the start because the assumption was wrong. Each category of these CNS diseases is defined by a collection of different biological subtypes. By standardizing human data, and then using AI to reverse engineer the disease, Lunai traces the biology of each subtype to the related genes and then discovers potential drugs of interest and test them in living systems. We did this for Supernus Pharmaceuticals (NASDAQ: SUPN) by identifying the right epilepsy subgroup for their lead candidate (SPN_817) phase 2 clinical trial. We have recently announced three distinct types of Parkinsons and are working towards commercial deals in Parkinsons and Alzheimer's.

We announced today that we are also applying our drug discovery platform to cancer through the launch of a new oncology collaboration with a clinical-stage partner to analyze data from a randomized Phase 2 metastatic colorectal cancer trial. Cancer trials are expensive and difficult, and many fail late because the right patients weren't identified early enough. What we're doing in the program announced today is straightforward to explain:

We're using Augusta to learn more from existing clinical trial data—combining patient clinical data, AI-derived imaging signals, and long-term outcomes—to identify which patients benefit most from a new colon cancer drug and why. 

Our technology platform identifies biologically meaningful subgroups that are designed to enable our partner to:

• enroll the right patients,
  
  
• choose the right endpoints,
  
  
• size trials more accurately,
  
  
• and reduce costly and time consuming late-stage risk in programs targeting FDA submissions.  

This engagement begins as a defined pilot, with a clear path to expand into a multi-study commercial relationship based on results. For Lunai, this is the kind of near-term work that can translate into repeatable revenue while proving out our approach in real-world datasets. 

Path B: AI Bio Defense discoveries, - prevention, response, and countermeasures when time matters

In parallel, Lunai has built a biodefense platform aimed at a hard problem: modern threats can spread quickly, and decision-makers often need answers when information is incomplete.

Our biodefense stack is designed to support the full lifecycle: 

Sentinel (Prevention): AI systems designed to help detect and prevent the misuse of chemical and biological knowledge before harm occurs. 

Pathfinder (Response): rapid assessment of emerging threats—predicting potential toxicity, affected organ systems, and mechanisms of action. 

CounterAct (Countermeasures): identifying and validating antidotes, including rapid repurposing of approved drugs and development of novel countermeasures where none exist. 

Our objective is to help the U.S. and allied stakeholders prepare for elevated geopolitical risk, including the possibility of chemical weapons deployment, and to support evaluation, regulatory pathways, and potential stockpiling of effective countermeasures. 

We are actively in negotiation's with Government programs and with private-sector partners given the urgency and national security alignment of this work, and we intend to share more details in the near term.  

How these two paths fit together

Both efforts rely on the same core idea: AI should not just generate hypotheses, - we have put AI to work owning serious patents and IP today, so it delivers usable answers:

• In healthcare: answers and tools that improve trial design and reduce development risk.
  
  
• In biodefense: answers and tools that improve prevention, readiness, response, and treatment options under pressure.

What we're focused on next (near-term milestones)

Over the coming period, our focus is to:

1. Advance late-stage commercial discussions across clinical data analytics, precision trial design, and biology-driven discoveries. 
   
   
2. Finalizing biodefense funding conversations and defining the roadmap for Sentinel, Pathfinder, and CounterAct.  
   
   
3. Complete a big new pharma Royalty partnership program on in-house immunotherapy technologies. 

We know many of you have read several Lunai announcements recently. The message we want to leave you with is simple: Lunai has established three immediately scalable revenue generating engines; AI powered drug discovery for CNS diseases and cancer and AI Bio Defense discoveries and tools, each designed for real-world impact, and each capable of creating long-term value and partnerships when implemented and executed with discipline; - our high level focus is driven by one thing only - creating value for our Shareholders. We are trying to fix one of the most expensive problems in medicine using a model that aligns perfectly with how drug development is evolving. When it executes, the gap between what it is today and what it could become is exactly how shareholder value is created.

Thank you for your continued support and confidence in Lunai's mission for a safer and better future for all. 

Sincerely,

David Weinstein

Chief Executive Officer

Lunai Bioworks, Inc. 

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding potential clinical impact, therapeutic benefit, development timelines, partnering strategy, and commercial value. These statements are subject to risks and uncertainties that may cause actual results to differ materially. Lunai Bioworks undertakes no obligation to update forward-looking statements, except as required by law.

SOURCE Lunai Bioworks Inc.