PureTech Regulatory News (PRTC)

13 May 2019

PureTech Health plc

PureTech Health Affiliate Vedanta Biosciences Closes Extended $45.5 Million Series C Financing

Extension raises $18.5 million in new capital to deliver data from three clinical programmes

PureTech Health plc (LSE:PRTC) ("PureTech Health"), an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) axis, is pleased to announce that its affiliate Vedanta Biosciences today announced an $18.5 million extension of its Series C financing round, bringing the total for the round to $45.5 million. The new investment comes from JSR Corporation, Shumway Capital, SymBiosis LLC, and Partners Investment Co., Ltd. These new investors join previously announced participants of the round which included the Bill & Melinda Gates Foundation, Bristol-Myers Squibb, Rock Springs Capital, Invesco Asset Management, Health for Life (Seventure Partners), and founder PureTech Health. As previously announced, the proceeds from the financing will be used to advance Vedanta's broad clinical portfolio in indications including food allergy, advanced or metastatic cancers, and infection. A clinical study is also being advanced with Janssen as part of an ongoing collaboration in inflammatory bowel disease.

Bharatt Chowrira, JD, PhD, president and chief of business and strategy at PureTech Health, said: "Expanding an already impressive syndicate with these additional investors is a tribute to Vedanta's differentiated clinical pipeline and platform which represent a new frontier for immune-mediated diseases."

The full text announcement from Vedanta Biosciences is as follows:

Vedanta Biosciences Closes Extended $45.5 Million Series C Financing

$18.5 million in extension funding will support clinical pipeline of microbiome-derived product candidates

CAMBRIDGE, Mass., May 13, 2019- Vedanta Biosciences, a clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria, has raised an additional $18.5 million as an extension of its Series C financing, bringing the total for the round to $45.5 million. The new investment comes from JSR Corporation, Shumway Capital, SymBiosis LLC, and Partners Investment Co., Ltd., who join previously disclosed investors the Bill & Melinda Gates Foundation, Bristol-Myers Squibb, Rock Springs Capital, Invesco Asset Management, Health for Life (Seventure Partners), and founder PureTech Health. Proceeds from the financing will be used to advance Vedanta's clinical portfolio including a Phase 1/2 study of VE416 in food allergy, a Phase 1b/2 study of VE800 and OPDIVO® (nivolumab) in advanced or metastatic cancers, and the ongoing Phase 2 study of VE303 in recurrent Clostridium difficile infection (rCDI). A Phase 1 clinical study of VE202 in healthy volunteers is being advanced with Janssen as part of an ongoing collaboration in inflammatory bowel disease (IBD).

"Our platform has the potential to address broad medical needs, including the treatment of drug resistant infection, food allergies, and other immune-mediated conditions where current approaches fall short," said Bernat Olle, PhD, co-founder and chief executive officer of Vedanta Biosciences. "This financing will enable us to continue to advance defined bacterial consortia as a new modality, including generating clinical readouts in multiple therapeutic areas, and we are grateful to our new and existing investors for their support."

Vedanta Biosciences is developing consortia of bacterial strains designed to effect robust and durable therapeutic changes in a patient's gut microbiota. In contrast to faecal transplants or administration of faecal fractions, Vedanta Biosciences' consortia are defined compositions of bacteria manufactured from pure, clonal cell banks, without the need to rely on direct sourcing of faecal donor material of inconsistent composition.

About Vedanta Biosciences

Vedanta Biosciences is a clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria. Vedanta Biosciences is a leader in the microbiome field with capabilities and deep expertise to discover, develop, and manufacture live bacteria drugs. These include what is believed to be the largest collection of human-gut associated bacteria, a suite of proprietary assays to select pharmacologically potent strains, vast proprietary datasets from human interventional studies, and facilities for cGMP-compliant manufacturing of rationally-defined bacterial consortia in powder form. Vedanta Biosciences' pioneering work, in collaboration with its scientific co-founders, has led to the identification of human commensal bacteria that induce a range of immune responses - including induction of regulatory T cells, CD8+ T cells, and Th17 cells, among others. These advances have been published in leading peer-reviewed journals, including Science (multiple), Nature (2013, 2019), Cell, and Nature Immunology. Vedanta Biosciences has harnessed these biological insights and its capabilities to generate a pipeline of programmes in infectious disease, autoimmune disease, allergy, and immuno-oncology.

Vedanta Biosciences was founded by PureTech Health (LSE.PRTC). Its scientific co-founders are world-renowned experts in immunology and microbiology who have pioneered the fields of innate immunity, Th17 and regulatory T cell biology, and include Ruslan Medzhitov, PhD, (Yale and Howard Hughes Medical Institute (HHMI)), Brett Finlay, PhD, (University of British Columbia and HHMI), Kenya Honda, PhD, (Keio University and RIKEN), Dan Littman, PhD, (New York University and HHMI), Alexander Rudensky, PhD, (Sloan Kettering and HHMI), and Jeremiah Faith, PhD, (Mount Sinai School of Medicine).

About PureTech Health

PureTech Health (LSE: PRTC) is an advanced biopharmaceutical company developing BIG medicines for dysfunctions of the Brain-Immune-Gut axis. The Company has gained deep insights into the connection between these systems and the resulting role in diseases that have proven resistant to established therapeutic approaches. By harnessing this emerging field of human biology, PureTech Health is developing new categories of medicines with the potential to have great impact on people with serious diseases.

PureTech Health is advancing a rich pipeline of innovative therapies with an unbiased, non-binary, and capital efficient R&D model across its affiliates and its internal labs. PureTech's affiliates include seven clinical-stage platforms, including one product that has been cleared by the US Food and Drug Administration (FDA) and a second product candidate that has been filed with the FDA for review, and several other novel preclinical programmes. The PureTech Health pipeline includes ground-breaking platforms and therapeutic candidates that were developed in collaboration with some of the world's leading experts.

PureTech's internal research and development is centred on tissue-selective immunomodulation for the treatment of oncology, autoimmune, and CNS-related disorders, with a near-term focus on targeting newly-discovered, foundational immunosuppressive mechanisms in oncology and novel approaches that harness the lymphatic infrastructure.

For more information, visit www.puretechhealth.com or connect with us on Twitter @puretechh.

Ownership Information

PureTech's percentage ownership of Vedanta Biosciences following the financing is approximately 57.4% on a diluted basis. This calculation of PureTech's holding includes issued and outstanding shares as well as options and warrants to purchase shares, but excludes unallocated shares authorised to be issued pursuant to equity incentive plans.

Forward Looking Statement

This press release contains statements that are or may be forward-looking statements, including statements that relate to the company's future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.