As the year draws to a close today, I’d like to reflect on the microbiome landscape in 2024:
Unfortunately, conditions remained particularly challenging for pre-revenue biotechs raising funds for microbiome-based therapeutic programs, and this was felt by the market with several programs discontinued, a handful of biotechs closing their doors, and even some microbiome industry-specific service providers shutting down.
Despite this, 2024 was an extremely significant and historical year for the field as we had indisputable scientific evidence that defined Live Biotherapeutics work!
Infant Bacterial Therapeutics’ Phase 3 readout demonstrated a 27% reduction in all-cause mortality for infants with necrotizing enterocolitis. Beyond its significance for the market as potentially the first FDA and EMA-approved single-strain LBP, Infant Bacterial Therapeutics’ product saves babies’ lives!
This, for me, is far more important than any short-term hurdles our industry is currently facing and is what should also be more important for everyone else too. At the end of the day, it is now a fact that defined LBPs have the potential to save lives, and IBT’s Phase 3 study comprising 2,153 premature infants is testimony to just that.
Of course, there were other important milestones reached by a number of companies progressing microbiome science in and out of the clinic, some sizeable fundraises, new spin-outs, and important clinical data. Furthermore, it was great to see some very sizeable public investment commitments.
Below, I share some highlights throughout 2024 and some of the things that I am particularly excited about coming up in 2025:
Fundraising in the Microbiome
Despite 2024 being a difficult year for early-stage biotechs, there were some significant investments across the microbiome field, such as:
$12M raised by Kanvas Biosciences, Siolta Therapeutics, and Z-Biotics.
A $10.4M strategic grant from the Bill & Melinda Gates Foundation into Freya Biosciences.
£27M raised by EnteroBiotix.
Additional funding rounds: $9M for Holobiome, $4.2M for Ancilia Biosciences, and $2M for Neobe Therapeutics.
€20M funding for SNIPR Biome from the European Innovation Council.
On the public funding side, the Dutch government allocated €200 million specifically for microbiome research through the establishment of the Holomicrobiome Institute.
M&A and Partnerships in 2024
2024 also witnessed strategic mergers and acquisitions:
The formation of the Cmbio brand through the merger of Clinical Microbiomics, CosmosID, MS-Omics, DNASense, and Microba’s Research Services Unit.
Probi’s acquisition by Symrise.
Lactobio’s acquisition by L’Oréal.
One standout partnership was between the Novo Nordisk Foundation, Wellcome Trust, and the Bill & Melinda Gates Foundation, with a $300M commitment aimed at advancing global health equity. Notably, the microbiome was highlighted as a key area of focus for addressing nutritional and immunological health challenges.
Clinical read-outs
As already mentioned, Infant Bacterial Therapeutics (IBT) reported positive Phase 3 results for their candidate targeting infant necrotizing enterocolitis, showing a 27% reduction in all-cause mortality. If approved, this would represent the first FDA approval of a single-strain Live Biotherapeutic Product (LBP).
Maat Pharma presented positive 18-month data for MaaT013, showing a clear overall survival advantage in acute Graft-versus-Host Disease (aGvHD) for 140 patients at the 2024 Annual congress of the European Society for Bone and Marrow Transplantation. As we enter 2025, I am particular excited for MaaT Pharma’s official phase 3 Ares read-out!
MRM Health announced positive Phase 2a results for pouchitis and ulcerative colitis, significant indications with substantial market potential.
EnteroBiotix reported successful Phase 1b results for their program in liver cirrhosis.
Seres Therapeutics shared positive Phase 1b safety and clinical results.
Additionally, during the Microbes in Women’s Health Congress in Copenhagen (April 2024), I had the opportunity to present alongside leading KOLs Caroline Mitchell and Jacques Ravel on the development of two multi-strain LBPs, LC106 and LC115, targeting bacterial vaginosis (BV). These drug products, each containing multiple Lactobacillus crispatus strains, were designed based on insights from stable vaginal microbiomes.
2024 also saw two landmark Nature publications:
Eligo Bioscience’s study on genetically modifying bacteria in the gut with nearly 100% efficiency.
Immunobiome’s research on microbiome-based cancer therapies, focusing on iron deprivation in the tumor microenvironment.
Some other promising 2025 clinical read-outs I am excited about include:
Genome & Company’s Phase 2 trials for GEN001, targeting stomach cancer and biliary tract cancer
Microbiotica’s Phase 1b trial for MB097, targeting advanced melanoma in patients who have failed to respond to immunotherapies
Biomica’s Phase 1 trial for BMC128, focused on patients with non-small cell lung cancer (NSCLC), melanoma or renal cell carcinoma (RCC) who previously progressed on immunotherapy
CJ Biosciences’ Phase 1/2 trial for CJRB-101, investigating its efficacy in solid tumours including NSCLC and melanoma
Everimmune’s Phase 1/2 trial for EV997, evaluating safety and preliminary efficacy in combination with immune checkpoint inhibitors for solid tumour
New spinouts on the scene
Despite the challenging fundraising landscape, 2024 saw the emergence of several promising biotech spinouts:
Ostia Biosciences (University of Toronto) – Developing probiotics producing novel antimicrobials, with trials starting in early 2025.
32 Biosciences (Ginkgo Bioworks) – Focused on diagnostics and therapeutic modulation of bacterial virulence.
Taylored Biotherapeutics (UCalgary) – Targeting the gut-brain axis for mental health applications.
Florey Biosciences (Harvard Wyss) – Innovating with engineered yeast strains to address antibiotic-induced microbiome disruptions.
Concordance Therapeutics are developing smart bacteria that localize to disease sites in the gut, consuming toxic metabolites and converting them into anti-inflammatory compounds.
The Consumer Microbiome Market
In 2024, the consumer microbiome market experienced significant momentum, driven by groundbreaking innovations and product launches from key players in the field. Next-Generation Probiotics (NGPs) continue to gain traction, offering targeted solutions for metabolic health, gut health, and women’s health.
Companies like Pendulum Therapeutics have showcased the potential of precision probiotics with products designed to address metabolic pathways. Similarly, Z-Biotics has expanded its footprint with innovative GMO-based probiotic solutions, addressing emerging consumer needs in metabolic health. Seed Health, on the other hand, has made notable progress in women’s health with their vaginal synbiotic, setting new standards for efficacy in microbiome-focused solutions.
These developments underscore the growing maturity of the NGP market, where science-backed innovation continues to drive both clinical and commercial success on a global scale.
Biose’s year in review
Reflecting on 2024, I am incredibly proud of the achievements of our team at Biose Industrie:
600+ bacterial strains manufactured.
80+ drug substance batches and 25+ clinical drug product batches produced.
10 million finished products delivered globally.
New major and fantastic clients onboarded, reflecting our growing global reputation.
Looking ahead, we are actively preparing for a Pre-Approval Inspection (PAI) by the FDA. This preparation is closely aligned with the clinical advancements of our clients’ programs and represents a critical milestone in enabling commercial manufacturing of approved therapies.
We will also be expanding of our Boston laboratory in 2025 to serve as a small-scale GMP Phase 1 product manufacturing suite, complementing its state-of-the-art R&D services.
Furthermore, we are heavily investing in cutting-edge technologies to enhance both efficiency and scalability. This includes advanced fermentation techniques, optimized anaerobic production processes, innovative lyophilization strategies, and real-time quality monitoring systems to guarantee precision at every stage of production.
Signing off
Despite difficulties and challenges faced by the microbiome field, 2024 will remain for me as a pivotal and extremely significant year for our industry, as it is the year in which defined LBPs showed therapeutic reality.
With significant clinical trial results, significant investments from the public and private sectors, new company formations and good science continuing to emerge, it is important that stakeholders of the industry continue to focus on their end goal, which is ultimately bringing new therapies to patients in need.
I can say with certainty that this is the goal which continues to drive the team at Biose Industrie to maintaining the gold standard in bacterial manufacturing.
With this, I would like to wish all our friends, colleagues, clients and collaborators a very successful 2025!
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