-Progress across all commercial and charitable clinical research programs

-Strong growth in headcount and facilities, including newly commissioned cGMP plant

-$36 million in new funding in 2H2022, including major new research grants and equity

Seattle, WA, January 5, 2023 – Lumen Bioscience— a clinical-stage biotechnology company developing biologic drugs for highly prevalent diseases — today provided a review of the company’s 2022 growth, including progress in its clinical development programs, GMP manufacturing expansion, and funding. Together, these efforts bolster Lumen Bio’s unique drug development and manufacturing platform: a new way of making and delivering biologic drugs that promises to transform the industry through increased speed, mass-market scale, and exponentially lower costs.

“In 2022 we experienced strong growth across all facets of our company and operations, positioning Lumen for significant events in the coming year,” said Brian Finrow, co-founder and CEO of Lumen Bio. “We’re especially grateful for the continuing support of our shareholders and charitable research supporters. Thanks to them—and our broad team of internal and external researchers—we face 2023 with tremendous optimism.”

Some aspects of 2022 progress include:

Commercial Pipeline — An accelerating pipeline of clinical stage programs targeting prevalent, unmet needs backed by blockbuster commercial opportunities.

• LMN-201 for prevention of C. difficile infection – LMN-201 is the world’s first rationally engineered, complex biologic cocktail to enter human clinical trials. The investigational product is orally delivered and designed to prevent C. difficile infection, a >$5 billion cash drain on the U.S. healthcare system. 2022 progress includes:
  • FDA cleared IND application supporting a Phase 2/3 multi-center, placebo-controlled trial to evaluate the efficacy of LMN-201 in preventing C. difficile recurrence (NCT05330182).
  • Completed Phase 1 pharmacokinetics trial (NCT04893239) demonstrating successful ileal delivery of LMN-201 and stability against human gastrointestinal protease digestion.
  • Published LMN-201 pre-clinical data manuscript (journal submission process underway).
  • Completed preliminary commercial planning and market analysis.
• Kyorin Pharmaceuticals collaboration – A new commercial collaboration with Kyorin Pharmaceuticals was announced in March.
  • Like Lumen’s other commercial programs, the investigational product is a cocktail of orally delivered therapeutic proteins.
  • The program remains on track to initiate clinical trials in early 2024.

• Biologic cocktail for treatment of inflammatory bowel disease (IBD) – An orally delivered biologic cocktail for treating and preventing IBD (Crohn’s disease and ulcerative colitis).
  • Lumen initiated preclinical development of this complex biologic cocktail in 2022.
  • Program remains on track for initial regulatory filings by the end of 2023.

Charitable (ESG) Clinical Development Pipeline — The unique scalability, low GMP COGS, and easy distributability of Lumen Bio’s products make them uniquely applicable for a variety of neglected diseases. Where public research funding is available, Lumen Bio is committed to opening its platform for these diseases.

• LMN-101 for traveler’s diarrhea – Major funding received for two additional mid-stage clinical trials in 2023, a gastrointestinal pharmacokinetics trial and an enhanced dose-ranging challenge study in C. jejuni. Lumen also made strong progress in the CARB-X-funded program to develop a broad antibody cocktail offering protection against most clinically important strains of ETEC and C. jejuni.
• LMN-301 for Covid-19 – In 2022, Lumen Bio’s Covid-19 funding consortium expanded to include BARDA and the Bill & Melinda Gates Foundation. Strong preclinical data with an intranasal formulation was announced in December. The program is on track to initiate human clinical trials in mid-2023.
• Intranasal malaria vaccine – Development of needle-free spirulina produced recombinant protein against malaria. Published findings in Nature Partner Journals (NPJ) Vaccines. Program funding renewed by NIH to advance the vaccine into IND-enabling studies.
• Antibiotic-resistant bacterial infections – In December, Lumen Bio announced significant new funding support from the US Navy Medical Research Center to develop a biologic cocktail to prevent antibiotic infections, a major unmet medical need in battlefield medicine.

Facilities, Platform, and Team

• Platform technology paper featured on the cover of Nature Biotechnology.
• Major expansion of cGMP manufacturing facility commissioned in Seattle.
• New lease quadrupling Lumen’s laboratory and office space at existing headquarters in Seattle.
• Expanded headcount to 90, with growth across the clinical, GMP manufacturing, R&D, and quality teams.

Funding – support from venture, grant funding and non-dilutive funds from collaborations

• Lumen closed an equity round in late June, bringing total venture funding to $43 million.
• Lumen announced multiple non-dilutive funding in the second half of 2022, including significant new support from BARDA, CARBX, The Bill & Melinda Gates Foundation, and USAMRD/MTEC ($20 million total).