Ernexa Therapeutics is a biotechnology company that develops innovative cell therapies for treating advanced cancer and autoimmune diseases. Pulse 2.0 interviewed Ernexa Therapeutics President and CEO Sanjeev Luther to gain a deeper understanding of the company.
Sanjeev Luther’s Background
Can you share a bit about your professional journey and background? Luther said:
“I’ve spent the past few decades working in the life sciences industry, with a focus on oncology, biotechnology innovation, and corporate leadership across both U.S. and global markets. My approach has always been strategic and pragmatic, aimed at helping companies navigate complex challenges, grow responsibly, and stay grounded in scientific and operational excellence. My mantra has always been to remain laser-focused with relentless execution, delivering hope to patients.”
“I’ve had the opportunity to lead clinical-stage biopharmaceutical companies through a wide range of business functions, including corporate strategy, R&D, investor relations, business development and licensing, regulatory affairs, and medical operations. At one company, I helped guide its evolution from an early-stage to a late-stage clinical organization, overseeing multiple global Phase 3 trials, managing budgets, and securing capital through institutional investors and partnerships. I’ve also led in- and out-licensing deals, product portfolio expansion, and commercial planning across therapeutic areas such as oncology, autoimmune disease, ophthalmology, dermatology, and CNS.”
“Prior to joining Ernexa Therapeutics, I served as President and CEO of Cornerstone Pharmaceuticals (formerly Rafael Pharmaceuticals), where I led operations and strategic direction and helped position the company for clinical and financial growth. Earlier in my career, I held leadership roles at companies including Mallinckrodt Pharmaceuticals, GE Healthcare, Bristol Myers Squibb, Bausch + Lomb, and Novartis, where I worked on commercial strategy, business development, and global expansion efforts.”
“Along the way, I’ve had the privilege of working with talented teams, managing organizations ranging from 10 to 200 people and overseeing budgets from $5 million to $500 million. I’ve also contributed to health policy initiatives, providing input on Cures 2.0, supporting U.S. manufacturing discussions, and contributing to congressional task force reports in 2020. Outside of industry, I serve on the board of non-profit South Asian Pharmaceutical Council (SAPC), which supports workforce development in pharma/biotech, and I’m involved in providing housing and food assistance to adults living with dementia.”
“Now at Ernexa Therapeutics, I’m excited to be part of a team that’s pushing the frontiers of cell therapy for the treatment of cancer and autoimmune disease.”
Primary Responsibilities
What are your primary responsibilities? Luther shared:
“As President & CEO of Ernexa, I’m responsible for defining and executing our strategic vision. That includes overseeing research and development, regulatory affairs, investor and partner relationships, and daily operations. I also work closely with our board of directors, scientific and medical advisory boards, and leadership team to ensure we’re making smart, science-driven decisions that advance our mission and benefit patients.”
Favorite Moment
Do you have a favorite moment or experience since joining the company? Luther reflected:
“One of the most rewarding experiences has been seeing our scientific vision come to life through the development of ERNA-101 and ERNA-201. Watching our team translate complex bioengineering concepts into promising therapeutic candidates – designed to meaningfully change the treatment landscape for patients with ovarian cancer and autoimmune disease – has been incredibly fulfilling. Another highlight has been establishing a culture of curiosity and rigor, where cross-functional collaboration drives innovation every day.”
“When I joined Ernexa, our burn rate was unsustainable, and much of the spending was not fueling innovation. By reducing expenses and focusing resources where they matter most, we cut the burn rate significantly and now dedicate the vast majority of our budget to R&D, positioning us to bring therapies into the clinic and, ultimately, to patients.”
Core Products
What are the core products or capabilities the company is built around? Luther explained:
“At Ernexa, we’re focused on developing synthetic, allogeneic induced mesenchymal stem cells (iMSCs) – engineered stem cells that offer a scalable, off-the-shelf treatment option without the need for patient-specific cell harvesting. These cells are derived from a single healthy donor and can be produced in large batches, making them consistent, reproducible, and readily available for multiple patients.”
“What sets our approach apart is the combination of synthetic bioengineering and allogeneic sourcing. By creating synthetic iMSCs, we’re able to enhance and optimize the therapeutic properties of the cells. And because the product is standardized and controlled, we can address some of the key limitations of traditional MSC therapies, such as immune rejection and short durability, while maintaining scalability and quality.”
“We are developing two highly innovative cell therapy products, both currently in preclinical stages. ERNA-101 is the company’s lead cell therapy product with a primary focus on ovarian cancer, designed to activate and regulate the immune system’s response to recognize and attack cancer cells. ERNA-201 is a cell therapy product designed to target inflammation and deliver the anti-inflammatory cytokine IL-10 to inflamed tissue, treating autoimmune disease.”
“Our goal is to deliver a next-generation cell therapy platform that’s not only effective but also practical for broad clinical use.”
Challenges Faced
What recent challenges has your industry presented, and how has the team navigated them? Luther acknowledged:
“Cell therapy is evolving rapidly, but the field faces real challenges around manufacturing scalability, regulatory pathways, and demonstrating durable clinical outcomes. Additionally, the competitive landscape is intensifying, and access to capital remains constrained for many biotech companies.”
“At Ernexa, we’ve navigated these headwinds by staying focused on our differentiated platform – synthetic, allogeneic iMSCs – and enhancing our development processes, from biomarker discovery to preclinical modeling and product optimization. Our team has remained agile, data-driven, and committed to building a reproducible, high-quality platform with long-term value. With laser focus, we invest 80% of every dollar spent on R&D wisely and strategically.”
Evolution Of The Company’s Technology
In what ways has your technology or platform evolved since launch? Luther noted:
“Since launching, we’ve made important advancements in the engineering and manufacturing of synthetic iMSCs. We’ve optimized the design of our cell lines for greater potency, persistence, targeting capabilities, and cytokine profiles. We continue refining our cell engineering strategies, optimizing products, and analyzing preclinical datasets to identify biomarkers and support patient stratification.”
“On the manufacturing side, we’ve partnered with experts in manufacturing under cGMP conditions, ensuring consistency and scalability.”
“These enhancements are helping us move with greater speed and precision toward the clinic.”
Significant Milestones
What milestones or achievements have been most meaningful for the company to date? Luther cited:
“Over the past year, we’ve made tremendous strides in advancing Ernexa’s strategic, scientific, and operational foundation.”
“One of the most meaningful milestones was the strategic repositioning of the company to focus on two areas of significant unmet need: ovarian cancer and autoimmune disease. This sharpened focus – fortified by our new name – reflects the strength of our platform and the urgency of the clinical challenges we’re aiming to solve.”
“From a scientific perspective, we’ve announced compelling preclinical data for our lead program, ERNA-101, in ovarian cancer – demonstrating its ability to activate the immune system, target the tumor microenvironment, and drive potent anti-cancer activity. We’ve since presented this data at major medical meetings, including AACR and ASCO, further validating our approach and building enthusiasm across the oncology community.”
“To support future clinical development, we established a Texas-based subsidiary that will serve as a hub for advancing ERNA-101 and scaling our operations. At the same time, we’ve expanded our scientific and medical advisory boards, integrating expert perspectives across oncology, immunology, and translational medicine to guide our path forward.”
“We also enhanced our board of directors and scientific and medical advisory boards to strengthen governance and position the company for long-term growth.”
“Collectively, these milestones reflect our evolution into a focused, clinically driven company with a bold vision for the future of cell therapy.”
Customer Success Story
When asking Luther about customer success story, he highlighted:
“As we’re still in the preclinical stage, we don’t yet have patient outcomes to share. But in preclinical models, we’ve seen remarkable tumor infiltration and immune activation using our IL-7/IL-15 iMSC approach.”
“These results give us confidence in our mechanism and reinforce the potential of iMSCs as a powerful delivery system. We’re eager to validate these findings in the clinic.”
Funding
When asking Luther about the company’s funding details, he revealed:
“We’ve taken important steps to strengthen Ernexa’s financial position as we prepare to enter the clinic. In the past year, we closed multiple rounds of financing. This capital supports our transition from preclinical development into clinical-stage operations and reinforces investor confidence in our platform, leadership, and strategic direction. We plan to raise our next round to provide runway through early 2027 and support key inflection points, including IND submission and first-in-human studies.”
“It also reflects the growing interest in scalable, next-generation cell therapies – particularly those, like ours, that are grounded in solid science and designed for real-world application. With this added financial strength, we’re well-positioned to advance ERNA-101 into first-in-human studies and continue developing ERNA-201 for autoimmune disease.”
Market Size
What is the size of the market you’re aiming to serve, and what’s the opportunity ahead? Luther assessed:
“The opportunity ahead is significant.
In ovarian cancer alone, 300,000 women worldwide are diagnosed annually, with a five-year survival rate of only 20% when diagnosed in late stages. Our goal is to address this urgent need with ERNA-101, especially among the platinum-resistant population, who have a significant unmet need.
On the autoimmune side, tens of millions of people worldwide suffer from diseases that are often treated with nonspecific immunosuppressants. ERNA-201 has the potential to offer a targeted, tissue-specific alternative.
With our scalable, off-the-shelf platform, we’re designing therapies that could reach broad patient populations with greater precision and fewer side effects.”
Biggest Differentiator
What do you see as your biggest differentiator in an increasingly competitive space? Luther affirmed:
“Our biggest differentiator is our synthetic, allogeneic iMSC platform. Unlike traditional MSC therapies, which often suffer from variability and limited durability, our approach delivers standardized, reproducible, and highly targeted engineered cell therapies that can home to disease sites and deliver potent therapeutic payloads.”
“This combination of tumor-homing capability, cytokine delivery, and platform scalability sets us apart. Additionally, our integration of AI across R&D gives us a competitive edge in accelerating insights and development.”
Future Goals
What are the company’s biggest priorities or goals looking ahead? Luther emphasized:
“Our top priority is advancing ERNA-101 into clinical trials for platinum-resistant ovarian cancer and continuing preclinical development of ERNA-201 for autoimmune disease. We’re also focused on scaling our manufacturing processes, expanding our leadership team, and deepening our strategic partnerships.”
“Ultimately, our goal is to bring transformative, scalable cell therapies to patients who need them most.”
Additional Thoughts
Is there anything else you’d like to share that we haven’t covered? Luther concluded:
“Biotech innovation doesn’t happen in isolation. I’m incredibly proud of the collaborative spirit at Ernexa and grateful to our team, advisors, investors, and partners who are helping bring our vision to life. We’re standing at the frontier of a new era in cell therapy – one where advanced engineering, smart data use, and bold thinking converge to deliver real hope for patients. We’re excited to be part of that future.”
