Cellares is a biotechnology company specializing in automating and scaling cell therapy manufacturing to enhance accessibility and efficiency.
Fabian, in our interview last year you mentioned that Cellares’ Cell Shuttle could become the de facto standard for cell therapy manufacturing within five years. It seems you have already advanced significantly. Could you share more about your recent progress and how your first Smart Factory in New Jersey is getting started?
Our New Jersey Smart Factory, announced in August of last year, is close to achieving CGMP compliance. We are ramping up to support our customers' clinical trials by the end of 2025. Coming out of stealth last August brought significant milestones, including a $255 million Series C funding round, Bristol-Myers Squibb joining as a strategic investor, and the launch of our Bridgewater Smart Factory. These events galvanized interest, leading to partnerships with biotechs like Lyell and Cabaletta and large pharma companies such as BMS and Gilead’s Kite Pharma.
Within one year of launch, we secured five of the eight large pharma companies active in cell therapy, achieving over 60% market penetration. This year, we announced CGMP-compliant Cell Shuttles in both South San Francisco and Bridgewater, with our California facility obtaining a drug-manufacturing license. This marks our transition from R&D to operations and commercialization, underscored by a $380 million deal with Bristol-Myers Squibb earlier this year.
You initially aimed for clinical readiness by the end of 2024. Is that timeline on track? When will patients receive therapies produced by your Shuttles?
We are aligned with our goal and anticipate supporting the first clinical trials by the second half of 2025. While our facilities and technology are ready, factors like customer regulatory filings and patient recruitment impact the timeline. These elements are crucial for the launch of clinical trials.
By the end of 2025, all timelines should converge, enabling patient access. This readiness reflects our shift from clinical-scale manufacturing in South San Francisco to large-scale manufacturing capabilities in Bridgewater, which can accommodate up to 38 Cell Shuttles compared to two in California.
Could you explain the importance of the Cell Q technology, which you have also recently launched, and its role alongside the Cell Shuttle?
Quality control is a major bottleneck in cell therapy manufacturing, as critical as the Cell Shuttle. While the Cell Shuttle automates manufacturing, the Cell Q automates quality control, replacing labor-intensive manual processes. Currently, quality control involves extensive manual testing across multiple instruments and generates 500 pages of paper records for each patient—a process unsustainable at scale.
Cell Q automates these tests, generates electronic batch records, and resolves the bottleneck in quality control. Together with the Cell Shuttle, it enables high-throughput, commercial-scale manufacturing, reducing costs by approximately half compared to traditional CDMOs.
What capacity are you building for patient therapies, and how does this compare to current industry output?
We are scaling for 150,000 patient doses annually across facilities in the U.S., Europe, and Japan. To put this in context, the entire industry produced just 8,300 doses in 2023. Our capacity addresses the shift from oncology-focused cell therapies, with smaller patient populations, to autoimmune diseases, which demand far greater output.
This dramatic expansion aligns with patient needs, requiring centralized manufacturing facilities on each continent to overcome logistical challenges. For instance, our European facility will supply the entire region, avoiding cold chain complexities tied to transatlantic transport.
Tell us more about your partnerships with Kite and Sony. How do these reinforce Cellares’ ambitions?
Kite Gilead is one of the two pharma companies publicly disclosed among the five we have contracted with—arguably one of the leaders in our space, alongside Bristol-Myers Squibb. Beyond these partnerships, we have formed technology collaborations with Sony and 908 Devices to enhance the second-generation Cell Shuttle.
Sony’s CGX10 cell sorter, integrated into the Cell Shuttle, introduces on-cartridge cell sorting and flow cytometry capabilities. This allows not only for precise cell sorting but also for analytics, such as measuring CAR-positive expression. These advancements significantly broaden the applications and efficiency of cell therapies produced using our technology.
Did you anticipate such rapid expansion at the start of this year?
Yes, this growth aligns with what I have shared in the past. We have achieved tremendous progress in a short time by creating the Cell Shuttle, which automates the entire cell therapy manufacturing process for 16 patients simultaneously—a significant leap compared to traditional methods handling one patient at a time. This innovation addresses critical bottlenecks in the industry, such as patients dying on waitlists despite the availability of life-saving FDA-approved therapies.
In addition to scaling throughput by 10 times, we are cutting costs by 50% compared to CDMOs. This shift makes outsourcing to Cellares not only more efficient but also more affordable than in-house manufacturing for pharma companies. It is a win-win: patients get treated, pharma companies unlock billions in revenue and higher margins, and they avoid the operational burdens of manual manufacturing.
Are you prepared for the challenges of rapid growth?
We have proactively planned for this growth by strengthening our leadership team. Recently, we added key executives, including CFO Justin McAnear, who brings extensive public company experience, notably taking 10x Genomics public. His expertise positions us well for future financial milestones.
Our COO, Ossama Eisssa, is another strategic hire. He previously managed commercial-scale facilities for Legend Bio’s Carvykti and Novartis’ Kymriah—two of the six FDA-approved cell therapies. His unmatched expertise and proximity to our Bridgewater facility make him an invaluable asset as we scale operations.
Do you plan to take Cellares public?
Going public is certainly on the table. While our board will evaluate all options, it is a viable path for Cellares and one we are preparing for as we expand and mature.
What progress do you hope to share when we speak again next year?
By this time next year, I expect to report on new enterprise agreements—our term for commercial-scale capacity reservation deals—similar to the $380 million agreement with Bristol-Myers Squibb. Additionally, we aim to support the first clinical trials for our customers, manufacturing cell therapy products that will be infused into patients. This represents a major milestone in our journey toward transforming cell therapy manufacturing.
