Helaina is a food science company defining a new category of consumer immunology by engineering and fermenting yeast to grow human milk proteins bringing the immune-benefits of mothers milk to consumer products, starting with infant formula.
Overview - Why We Built Helaina:
Helaina is a yeast fermentation-based food science company defining a new category of consumer immunology. Helaina is bringing the immune-benefits of human milk to consumer products, starting with infant formula. Founded by food scientist and nutritionist Laura Katz, Helaina applies advanced bioengineering and precision fermentation technology, using yeast to make immune-equivalent human milk proteins for infant formula products.
Laura founded Helaina in 2019 in New York City after spending several years as an Adjunct Professor in the Department of Nutrition and Food Studies at New York University. Having worked in the nutrition and food industry, Laura was inspired by the rapid innovations in alternative proteins being applied to the meat and dairy industries and saw an opportunity to disrupt the infant formula market with a novel alternative protein solution to feed babies. Her vision is to offer babies the highest level of nutrition and immune health moving away from existing infant formula products reliant on animal proteins. While Laura still emphasizes that breastmilk is best, she is striving to offer mothers a near equivalent alternative, especially for the 89% of new moms that struggle to provide breastmilk for their newborns. With a passion for women’s health, Laura conducted extensive research, interviewing more than 150 mothers, and saw the painful challenges most mothers faced with breastfeeding.
The global infant formula market is currently dominated by bovine milk based products with ingredients like corn syrup, sugar, palm oil and maltodextrin. Formula fed babies are more likely to suffer from infections, obesity, and respiratory tract problems in their adulthood than those that are breastfed. Even with the entrants of organic options, there is no infant formula on the market that is made with human proteins. To ensure the mission of providing a healthy early life for the children as well as peace of mind for parents, Laura recruited world class scientists to engineer yeast and ferment it to create patentable proteins. Through Helaina’s proprietary technology, they have taught their yeast to pump out proteins that mimic the immune health attributes of mothers milk.
Through advanced bioengineering and precision fermentation, Helaina’s scientists are using yeast strains -- previously approved by the FDA for various food productions -- to recreate human milk proteins that mimic immune attributes of mothers’ milk. Helaina has filed IP to protect this technology and its high yield yeast strain. With proprietary technology and ongoing innovation, Helaina’s pipeline includes a range of human milk ingredients in development. Using yeast provides Helaina a strategically innovative pathway to commercialization. Yeast has been used for thousands of years to make food ingredients and it is approved by the FDA. Helaina has embarked on their FDA approval process with a target of launching in stores by 2023. In an effort to achieve production at scale at mass market pricing, Helaina has already secured manufacturing partners for the fermentation and production of their infant formula product.
Highlights:
Strong, diverse and seasoned investors. Helaina has attracted a top tier group of investors including Spark Capital, Primary Ventures, and Siam Capital, among others.
Investment Opportunity:
Helaina has just closed a $20M Series A round at a pre-money valuation of $45M led by Spark Capital and Siam Capital. The Plum Alley team has successfully reserved an allocation of up to $1.5M for the Plum Alley Investor Member Syndicate and the Plum Alley Ventures Fund. Of note, the Series A round was oversubscribed and recently closed. However, the Company is reserving an allocation for Plum Alley. We will work closely with Helaina to try to accommodate all member interests. Please submit your commitments here early to help accommodate all orders.
Helaina’s Series A is being led by Spark Capital, an investor of Affirm, Carta, Cruise, Discord, Oculus, Plaid, Postmates, Slack, Twitter, and Wayfair. Other key participants in the round include co-lead Siam Capital and Helaina's seed investor, Primary Venture Partners, an early-stage investor in NYC startups like Jet, Chief, Mirror, K Health, Noom, Latch, Alloy. The Plum Alley investment team completed diligence conversations with Primary Ventures and Siam Capital.
Series A funding will be used to complete the clinical growth study and submit for FDA approval, as well as to support the supply chain scale up and brand & retail partnership-building towards the targeted product launch in 2023. Helaina previously raised a Seed round, which was used to establish its world class team of scientists, build its lab at NYU Langone, establish its proprietary fermentation process, and secure a manufacturing partner.
Market Opportunity & Go to Market:
Helaina is initially focused on achieving commercialization for its infant formula product in 2023.
Market Opportunity and Landscape
Consumers around the globe are increasingly embracing alternatives to animal proteins due to environmental and health considerations. The adoption of alternative proteins will have a measurable positive impact on human health and the environment. What we see today is only the beginning of the alternative protein disruption. In 2021, Boston Consulting Group’s (“BCG”) research data shows that by 2035, every tenth portion of meat, eggs, dairy and seafood consumed globally will be made from alternative protein. Furthermore, the alternative protein market is set to reach $290B as consumer demand accelerates for plant, lab grown cell, and microorganism-based alternatives. BCG highlights that beyond plant-based alternatives, those alternatives produced by microorganisms such as yeast, fungi, or bacteria, or through the cultivation of live animal cells, will see robust market growth.
The global infant formula market size was valued at $70 billion in 2020, with $6.8 billion in the US. This market is projected to reach $100 billion by 2026 with a CAGR of 8% during the forecast period. Helaina’s total addressable market (TAM) exceeds $500 billion in maternal wellness, toddler nutrition and functional foods markets together. Furthermore, with more women returning to work, the demand for nutrition-rich infant formula is rising throughout the world. Increasing demand for clean label, plant-based and organic products has emerged together with a trend towards innovation of vital ingredients such as probiotics and human milk oligosaccharides (HMO). The consumer-driven and rapidly evolving infant formula market can be categorized in the following four groups:
(i) legacy formula brands - cow’s milk based brands like Similac, Enfamil, Gerber
(ii) new formula brands - cow’s milk brands that are organic and grass fed like Bobbie, HiPP and others
(iii) cell-based breast milk alternatives - stem cell based technology that is still quite capital intensive including BioMilq and Turtle Tree Labs
(iv) microbial breast milk alternatives
Microbial breast milk alternatives: This group, including Helaina, uses microbe fermentation to create breast milk ingredients, representing a novel solution in the infant formula market and more broadly for family nutrition. Yeast fermentation has been used traditionally in many food production processes, including bread making and brewing. Yeast grows rapidly and can be easily engineered. There have been successful examples of using yeast for novel food applications including with Impossible Foods, and there is a robust regulatory and manufacturing infrastructure for faster FDA approval as well as production scaling. Other companies in this space include Harmony Baby Nutrition (Founded in 2018) and Sugarlogix (Founded in 2012), representing direct competitors of Helaina. Please refer to the Plum Alley investment memo for more details on the market landscape.
Go to Market Strategy
Helaina plans to launch the first Hero Product, an immune equivalent infant formula with human lactoferrin, following the FDA approval via the GRAS (Generally Recognized as Safe) designation in 2023. They have referenced the regulatory pathway paved by Impossible Foods & Perfect Day. Compared to Impossible Food’s 7-year and Perfect Day’s 6-year FDA approval timeline, Helaina projects it will be able to achieve FDA approval within 3 years from initiation. Helaina is aiming to be the first yeast fermentation-based novel human protein formula brand to go to market, in Q3 2023.
Helaina has already established its relationship with the FDA to map out a pathway to approval. Working with advisor Dr. Mike Pariza, who’s been on numerous GRAS panels in the past and developed the regulatory framework for evaluating safety of microbial expressed ingredients, Helaina’s regulatory approval plans include 3 key steps:
(i) immunoassay testing (test the lactoferrin for its immune equivalency to human lactoferrin)
(ii) toxicology testing (a requirement that all new food ingredients be tested for their toxicological potential)
(iii) infant growth study (FDA-mandated clinical test in infants).
All new infant formulas must feed their product to infants for 15-week and monitor growth. Helaina is partnering with an industry leader, Paidion Pediatric Clinical Research Institution, who will design, run, and analyze this study, starting in Q2 2022.
Beyond regulatory approval, Helaina’s go-to-market plan includes several key components, including building a trusted brand with consumers, establishing education and awareness for microbial based infant formula, and building a deep expert and influencer network. Helaina has already launched efforts on these fronts, including conducting a customer study and securing a group of celebrity mom investors who are joining Helaina’s Series A round. Helaina also intends to build partnerships with clinicians, leveraging the clinical studies as well as sharing the team’s research papers with the medical community.
Brick and mortar storefronts are the main formula sales channel, and account for 80% in the US market. Having established partnerships with industry leaders for manufacturing and distribution to enable a scalable supply chain, Helaina is currently in search for a retailer partner. Once they have the momentum with parents and doctors, Helaina will launch the first product exclusively with a mass retailer in Q3 2023, with the plan to expand through grocery chains, online marketplaces and DTC subscription model in the future.
Helaina Product & Technology:
Helaina uses a proprietary yeast fermentation technology to recreate human milk proteins found in mothers’ milk. In the upstream production, food scientists grow yeast that excretes the human milk proteins of interest, while the downstream process recovers those proteins and removes any impurities.
To start the process, Helaina’s strain engineers genetically modified yeast cells and invented a proprietary yeast strain called “Secretion Signal” that can produce proteins in large quantities. A provisional IP has been filed on this newly invented strain. Helaina scientists then engineer this strain to contain a DNA fragment of a target protein, following which these yeast cells are ready to efficiently produce this protein.
Proprietary Production Process
In the Upstream, the yeast cells are “woken up” from a freezer and moved into the bioreactor to grow in optimal conditions. Once the cells are mature in the reactor, the protein production phase is started. Media is added to both maintain cell health as well as start the production of the proteins of interest till they reach a certain level, then the Downstream process begins. At the Downstream, once the fermentation is complete, the yeast cells and the proteins they produced will be separated via a centrifuge. The proteins then pass through a series of filtration steps to be purified. Finally, the proteins of interest are inserted into a media and are ready to be made into Helaina’s formula product.
Of note, the media needed to feed yeast is much cheaper than the one for stem cells. Additionally, yeast and yeast-made ingredients are already approved by the FDA for food production while stem cells are not. There have been successful examples of yeast fermentation applications in food production to prove the commercial viability, but cell culture has never been commercialized for food. That’s why Helaina chose to work with yeast over cell culture and how they are differentiated from the cell-based formula brands.
Product Roadmap
Lactoferrin (LF) is one of the most important components of the human immune system, known for its antimicrobial activity as well as the important role in brain development and inflammatory responses. Helaina chose to work with LF first because it is well studied and is one of the most predominant proteins in mothers’ milk. It is a perfect immunomodulatory molecule for lowering inflammation and adverse allergy responses, but also ramping up healthy immune support. The immune support is reflected through anti-pathogens in infant guts to help with overall growth and development, among other examples.
Helaina’s ambition is that its innovation will grow with a range of immune-equivalent human milk ingredients in their product pipeline, including:
- Alpha-Lactalbumin: helping babies absorb nutrients
- secretory Immunoglobulin A (sIgA): fighting against infection
- Lysozyme: protecting against pathogenic bacteria
- Breast Milk Fat: supporting healthy brain development
In the future, Helaina aims to expand their consumer immunology product line to include toddler formula, prenatal vitamins and nutrition shakes, as well as engage in licensing opportunities with trusted partners in adjacent markets, including animal feed, dietary supplements, functional foods and pet food, to use Helaina’s ingredients for their product applications.
Leadership Team:
Helaina has recruited a superstar team of world class scientists, including immunologists, food scientists and biochemists. Collectively, they have published scientific research in yeast engineering, human milk, and immunology that has been cited over 700 times. They are also working with renowned industry experts as their advisors & partners to help with product development and regulatory approval strategy.
Laura Katz: Founder & CEO. Laura is a Canadian expat and expert food scientist. She has spent her career developing food products for companies including NUGGS, Plated, and Dylan’s Candy Bar. In 2017, Laura was invited to teach Food Science & Technology as NYU’s youngest ever adjunct Professor.
Dr. Pamela Botero Besada-Lombana: Lead Strain Engineer. Pamela is a yeast expert who has received her PhD in Chemical and Biochemical Engineering by UC Irvine. She has also received two master’s degrees in Bioengineering and Chemical, Biochemical Engineering.
Dr. Baidya Nath Sah: Lead Food Scientist. Dr. Sah is a renowned Human Milk expert. He is one of the top researchers in the world working on the development of recombinant human milk antibodies, in addition to the vast number of key studies on human milk he has conducted over the course of his career.
Dr. Rupsa Basu: Immunologist. Rupsa received her Master’s in Immunology at Presidency University, PhD in Immunology at Michigan Tech. She is an expert in vaccine development and has worked in developing the universal flu and COVID-19 vaccines under the guidance of Dr. Fauci from NIH.
Impact:
140M babies are born each year globally, and the majority of moms struggle to provide breast milk for their newborns and are forced to use infant formula. Many parents are going to great lengths to ensure a healthy future for their children. Combining advanced bioengineering and traditional yeast fermentation, Helaina uses the most novel and commercially viable technology in infant formula innovation to recreate immune-equivalent human milk proteins to provide the first immunity building, digestion and gut health support for infants. Helaina was founded to help establish optimal immunity and gut health for babies from day one. As an alternative to bovine milk based formula products, Helaina is also making a positive impact on the environment. As a food science platform, Helaina aims to utilize their proprietary technology and expand their product lines, to redefine food and nutrition, consumer immunology and wellness, and become a global brand consumers trust and choose.
Sources: Helaina Data Room, CB Insights, PitchBook, Boston Consulting Group, Fortune Business Insights, Clara Health
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