Founder Spotlight #51: Nikole Kimes @ Siolta Therapeutics
BIOS: Nucleus of Life Science Innovation 🚀
JOBS
- BIOS Talent: Find Jobs @ Breakout TechBio Companies — Search Jobs 🚀
- Post Jobs: Add Your Startup to BIOS Talent — Post Now 🎉
- Students: Join Alix Ventures Fellowship — Join Now 🧬
- BIOS Contributor: Share Your Thought Leadership — Join Now🔬
CONTENT & COMMUNITY
- BIOS Daily: Join 25K+ Subscribers Following TechBio — Sign Up 🔥
- BIOS Insider: Premium TechBio Thought Leadership — Sign Up ✨
- BIOS Commons: World’s Largest #TechBio Community — Join Now 🎉
INVEST
- BIOS Angels: 1st TechBio Angel Investing Syndicate — Join Now 🌟
- Alix Limited: Invest in Breakout TechBio Startups — Learn More 🧠
By:
Alix Ventures: Supporting Early Stage Life Science Startups Engineering Biology to Drive Radical Advances in Human Health
Calling All Innovators — Click to Reach Out 🚀
Siolta Therapeutics is a clinical-stage biopharmaceutical company developing targeted microbiome-based therapeutics to prevent and treat diseases of high unmet medical need. Its lead program, STMC-103H is currently in phase 2 development to prevent atopic diseases in at-risk newborns. Siolta has successfully scaled up a multi-strain LBP drug product STMC-103H (>100K doses), completed a First-In-Human descending-age clinical trial (STMC-103H-101), and was recently awarded a $2.7M NIH grant to further advance its proprietary mixed-strain LBP manufacturing methods. By leveraging its Precision Symbiotics Platform™ the company is expanding its product pipeline into additional pediatric and women’s health indications.
Nikole Kimes is CEO & Co-Founder @ Siolta Therapeutics. Driving Siolta’s early-stage development, Nikole heads a talented team of scientists, blending microbiology, immunology, and bioinformatics expertise to leverage microbiome data for the improvement of patient stratification and development of precision microbial therapeutics. Nikole has over a decade of experience in microbial ecology and host/microbe interactions, supported by the National Science Foundation (NSF), the European Commission FP7, and the University of California San Francisco (UCSF). As an inventor of Siolta’s technology, her research in Susan Lynch’s lab @ UCSF provided the foundation for the company’s translational research program. Nikole is also the Chairman of the Microbiome Therapeutics Innovation Group (MTIG), an independent coalition of companies leading the research and development of FDA-approved microbiome therapeutics to address unmet medical needs, improve clinical outcomes, and reduce health care costs.
Personal Spark
What prompted you to pursue a career in Life Sciences? Was there a specific moment in time or influence you can remember? What drives you to work in this space?
I have always had two loves from an academic and career perspective: human health and environmental science. These concepts were often presented as competing interests despite my intuitive sense suggesting that they are intrinsically and inextricably linked. Thus, my early academic career was a bit meandering as I attempted to find ways to combine both passions in a single career objective.
Early in my career, I obtained a BS in science and a MA in holistic health, followed by a stint in the Peace Corp teaching human health, environmental education, and basic business principles, and after which I returned to human health doing neurobiology research. Although each of these events were vital to my development, I had not yet successfully integrated my interests in a meaningful manner.
As a result, I kept searching for something I could not yet name or fully describe. I eventually found myself in a unique opportunity to participate in a PhD program at the Medical University of South Carolina (MUSC) that combined environmentally focused molecular and cellular biology with translational human health. Although the genesis for this program was more of a small molecule drug discovery approach, my exposure to systems biology was life altering and afforded me the “ah ha” moment that I had been seeking.
Can you tell us a bit about your background & career thus far? What were you doing before you started leading a startup?
My doctoral work focused on characterizing environmental microbiomes (e.g., the coral microbiome) both taxonomically and functionally. My particular focus was on how these amazing microbial systems were influenced by changing environmental parameters and consequently impacted the health of the entire ecosystem. During this time, I learned to appreciate not only the intricacies of specific molecular interactions but also the complexity of interdependent networks driving a given ecosystem’s functionality.
This grand awakening in my own education occurred in parallel with the broader microbiome revolution that has changed our understanding of all ecosystems, including the human holobiont. A term that references the co-evolution of human beings with their complex microbial counterpart, the human microbiome. It was always my belief that if we could unlock the connection between our environment and our health, we would be able to address health conditions that had to date remained significant unmet clinical needs due to their complexity and recalcitrant nature (e.g., chronic inflammatory diseases and multi-factorial infections). At this point in my education, I had the tools to elucidate more specifically how the human microbiome connected our environmental exposures to our long-term health. This revelation and knowledge provided a much clearer vision of my future from an academic and career perspective.
Importantly, my family and I chose to return to San Francisco where I sought to find an innovative scientist as a mentor in the human microbiome space. This was a critical step in which I had the privilege of working with an amazing scientist, Dr. Susan Lynch at UCSF. She had incorporated an ecological perspective into her understanding of the human microbiome and more specifically its impact on systemic health through immunomodulation in early life development. This approach and years of scientific research coming out of Sue’s lab was eventually the foundation on which we have built Siolta Therapeutics.
Genesis
Tell us about the founding of your company — how did everything come together?
The founding of Siolta Therapeutics at its very foundation is a scientific story. Dr. Lynch is a pioneer in the human microbiome field, and her work has moved far beyond the early characterization studies. In fact, her work has provided greater understanding of the gut microbiome’s systemic modulation of immune development and overall health. As a result of her work at UCSF, Sue worked with influential people, such as Marc Benioff, and eventually interacted with the different players in biotech, including venture capitalists such as Samir Kaul. As a result in 2016, there was a fortuitous alignment of factors. First and most importantly, the science proved to be compelling in a more mature manner than previously. Second, the interest in backing an innovative approach that would truly transform our approach to healthcare existed. Finally, although I had never previously considered becoming an entrepreneur, I was open to the unique opportunity at hand.
What felt random in the moment proved to make perfect sense in reflection. Much like Systems biology is not a linear process; founding a successful company requires an almost mystical confluence of events in a complex, yet systematic way that is not always obvious initially.
How did you get your training, if any, to be able to build your company?
The early days consisted of a lot of on the job learning. The amazingly supportive early biotech support systems available in the Bay area, MBC BioLabs and California Life Sciences for example, were also essential to our initial success. I learned the vast majority of what I needed to know through a welcoming community that openly and willingly shared their experiences and resources. I was willing to ask questions about all the things I never even knew I needed to know to develop therapeutics, everything from business licenses to intellectual property to accounting practices. The skills for building a team were a bit more intuitive, although they needed to be fostered through mentoring and guidance. Interestingly for me, I found all the new aspects of daily life to be just as compelling as the science, and eventually it became clear that I was actually the perfect person to lead this company on a such a unique journey.
Company Overview
What problem is your company solving?
Traditional drug development often utilizes screened molecules to target specific pathways in the body that help alleviate the symptoms of disease. Although effective in many ways, this approach does not alleviate the underlying cause of disease and often is associated with unwanted side-effects. In contrast, our microbiome-based therapeutics are designed to work with the body’s natural systems to stop diseases before they start. We know that the human microbiome plays essential roles across a broad spectrum of critical functionalities in healthy individuals, including proper metabolism, immune modulation, inflammatory signaling, and even neurophysiology. This provides a natural reservoir of synergistic therapeutic agents that can work together to address the underpinnings of complex and multifactorial diseases, and we founded Siolta to develop targeted microbiome-based therapeutics that have the potential to be more efficacious with less side-effects.
How did you become motivated to tackle this particular problem?
Through our work at USCF, we recognized that the gut microbiome plays a critical role in regulating the immune system and that modulating it could potentially provide a novel approach to treating inflammatory-related diseases. Our team at Siolta Therapeutics have been working on developing therapeutics that can restore the balance of the human microbiome in infants at risk of developing atopic diseases (i.e., atopic dermatitis, food allergy, and allergic asthma) as well as other indications.
Quite simply, what does your company do?
Most simply stated, we are harnessing the human microbiome to develop a new class of drugs that will address the underlying causes of disease. To do this, we are integrating sophisticated bioinformatics with complex biology to develop targeted therapeutics and diagnostics across a number of indications.
Now in more depth, what are the specifics of what your company does?
Siolta Therapeutics is a clinical-stage biotechnology company that develops targeted microbiome-based therapeutics to prevent and treat diseases of high unmet medical need. Our lead program, STMC-103H is currently in phase 2 development to prevent atopic diseases in at-risk newborns.
Our targeted consortia Live Biotherapeutic Products (LBPs) are defined, multi-strain, combinations of live bacteria of high therapeutic value, isolated from the healthy human microbiome, and manufactured under strict pharmaceutical grade GMP standards.
Siolta Therapeutics is a biotechnology company that develops microbiome-based therapies to treat and prevent inflammatory diseases and recurrent infections. The company’s initial focus is on the role of the gut microbiome in immune system development and function. Siolta’s lead therapeutic candidate is a live biotherapeutic product called STMC-103H, which is designed to modulate the gut microbiome to prevent or treat a range of inflammatory diseases, including allergic asthma and eczema. Siolta is also developing a pipeline of microbiome-based therapies for unmet needs in women’s health and rare pediatric disease.
Why does your solution matter for the world when you get it right?
Imagine holding your new born baby and knowing that they are at-risk for developing a life-long chronic disease. Now imagine being provided a relatively low-cost solution that you provide in the first months of life that would alleviate that outcome. Siolta’s approach is to target multiple mechanisms of action simultaneously in order to solve for the underlying “root” cause of disease, rather than simply addressing individual symptoms. This approach has the potential to provide more comprehensive and long-lasting treatment outcomes for patients. This approach of addressing disease before it causes permanent damage is a fundamentally different way of thinking about healthcare. Not only would it transform health outcomes, it would also dramatically reduce the cost burden of such diseases.
Accomplishments
What are some of the notable milestones your company has achieved thus far?
Deciding to start a company, I imagine is never an easy task. We are focused on a solution that involves emerging technology; we are integrating a transformative approach focused on prevention; and we believe that we will be most impactful if we start with our children. Although traditional drug development norms would readily argue against our approach, the science is telling us something different. At Siolta we are compelled by the science to follow a different path, and we are proud of the team we’ve built both internally and externally to support such a unique endeavor. Although we have had to build each stepping stone along the way, we have successfully navigated a path from academic ideation into clinical trials to test this potentially groundbreaking approach in an amazingly efficient manner having added significant value and de-risked our future efforts substantially.
Siolta has successfully scaled up a multi-strain LBP drug product STMC-103H (>100K doses), completed a First-In-Human descending-age clinical trial (STMC-103H-101), and was recently awarded a $2.7M NIH grant to further advance its proprietary mixed-strain LBP manufacturing methods. By leveraging its Precision Symbiotics Platform™ the company is expanding its product pipeline into additional pediatric and women’s health indications.
What are some of the biggest hurdles ahead? How do these create points of value inflection?
We are currently enrolling in our Phase 2 adored study for the prevention of allergic diseases in newborns. Making sure that we continue to attract talent to our team.
Pay It Forward
Throughout the journey, what have been some of your biggest takeaways thus far? What advice/words of wisdom would you share from your story for other founders?
Systems, whether they are ecosystems, biological systems or even human systems, are always complex, multifactorial, and powerful. From this perspective rarely is anything a simple linear equation. One of the greatest lessons I’ve absorbed along this journey has been to accept a systems perspective for my own life trajectory. Often, we like to think of successful leaders as being visionaries who knew from day one what the solution needed to be. When in reality there is a complex web of experiences, knowledge and serendipity that occurs over time driving the greatest outcomes. As an entrepreneur, do not be fooled into thinking there is “a right path” because there are always alternatives and it’s more important to find the path that is uniquely suited for you. As long as you have an idea, determination, and resources, it can be done in many different ways.
What are some of the must-haves for an early stage Life Sciences startup in your eyes? (Key critical components like team, academic papers, industry know-how, etc.)
The right team, mission and vision. Also make sure you have strong IP to operate in your space.
What are some of the traits that make a good founder? What type of risk profile/archetype does someone need to have to be a founder in your opinion?
Grit and strong persistence. Determination to keep going.
For folks coming out of academia, what advice would you share?
Do enough market research on the industry you’re planning to go into. Talk to as many people as possible about the problem you’re trying to solve.
Not everyone knows everything. Often founders have to learn either the science or the business side better. What advice would you give for someone picking up a new skill set such as this?
Find great advisors and mentors. There are also a number of great accelerator and incubator groups these days like Nucleate or Pillar VC.
Can you demystify the process of what it takes to raise VC funding? What were the highlights & lowlights? Any advice or words of wisdom for future founders?
Remember to stay grounded, and make time for yourself during the fundraising process. It can get tough at times, so make sure you have a strong support network and system. You have to find the right investors who will believe and support you on a long-term basis, and if that fit isn’t right — move on. Bringing on a VC or investor to your Board who is not aligned with your vision, will significantly hinder company growth. Make sure you’re focusing on the right fit, and not just the term sheet.
What advice for managing and hiring a great team can you share?
Hire A-level team members. Hire the best talent, to create the best work. Provide an internal culture for mentorship and training for onboarding.
📣 If you enjoyed this post please clap 👏 & comment 💬 to let us know
Alix Ventures, by way of BIOS Community, is providing this content for general information purposes only. Reference to any specific product or entity does not constitute an endorsement or recommendation by Alix Ventures, BIOS Community, or its affiliates. The views expressed by guests are their own and their appearance on the program does not imply an endorsement of them or any entity they represent. Views and opinions expressed by Alix Ventures employees are those of the employees and do not necessarily reflect the view of Alix Ventures, BIOS Community, affiliates, and content sponsors.
Join BIOS Community 🎉
Become a member, continue the conversation, connect with like-minded Life Science innovators, access exclusive resources, & invite-only events…
Apply to Join — Membership Application
For More Interesting Content 💭
🧬 Podcast — Stream Full Episodes
🧪 YouTube — Watch Videos
🩺 Twitter — Explore Feed
🦠 LinkedIn — Read Posts
