Tag: PRTC

PureTech Health plc (Nasdaq:PRTC, LON:PRTC), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, has announced the appointment of Robert Lyne as Chief Portfolio Officer. Robert brings a decade of experience in international life science deals and portfolio management, along with governance and executive team leadership experience.  Robert is expected to join PureTech by early January 2024.

“We are excited to welcome Rob to our management team and pleased to add a dedicated presence representing our senior leadership team in the UK as we work to deliver impactful new treatments for patients,” said Daphne Zohar, Founder and Chief Executive Officer of PureTech. “His extensive legal, operational and UK listed IP commercialization experience is complementary to PureTech’s own hub-and-spoke business model. We are looking forward to working together closely as we realize the full potential of both our Wholly Owned Programs and Founded Entity stakes and royalties.”

Mr. Lyne joins PureTech from Arix Bioscience plc, a transatlantic venture capital company focused on investing in innovative biotechnology companies, where he served as General Counsel and Chief Operating Officer before being appointed Chief Executive Officer in April 2021. He began his career as a lawyer at international law firm Bird & Bird LLP in London before moving to Touchstone Innovations, a London listed biotech and technology investor, which was acquired in 2017. He has worked on over 80 venture capital financings in Europe and North America as well as multiple trade exits and IPOs. As an experienced UK plc executive, Mr. Lyne has broad experience formulating and implementing corporate strategy. Mr. Lyne has a BA from the University of Oxford and an LLB from Oxford Brookes University.

“I am delighted to be joining the management team at PureTech during such an exciting time in the Company’s growth,” said Mr. Lyne. “As pioneers of the hub-and-spoke model in the biotechnology sector, PureTech’s approach is aligned with my own experience and ambitions. They are highly innovative in their approach to both science and business, which has led to the team delivering an impressive track record of developing new therapies with transformational potential. I look forward to working with the skilled team at PureTech and its outstanding network of advisors to further drive the Company forward.”

PureTech Health plc (Nasdaq: PRTC, LON:PRTC), a clinical-stage biotherapeutics company, has noted today that its Founded Entity, Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, has announced the publication of Phase 2 study results from its lead program, VE303, in the Journal of the American Medical Association (JAMA), as well as a late-breaker oral presentation at the European Congress of Clinical Microbiology in Infectious Diseases (ECCMID) annual event.

The JAMA paper, “VE303, a Defined Bacterial Consortium, vs. Placebo for the Prevention of Recurrent Clostridioides difficile Infection: A Randomized Trial,” expands on the results of the Phase 2 study of VE303, which was designed to identify the recommended dose for a Phase 3 study of VE303. The study data confirmed that VE303 prevented recurrent Clostridioides difficile infection (CDI) compared with placebo in the study population. The publication announced today includes new analyses of secondary efficacy endpoints, such as CDI recurrence rates at week 24, and stool microbiome endpoints, which included both VE303 strain colonization and gut microbiome diversity.

The ECCMID presentation offers more in-depth scrutiny of VE303 strain colonization dynamics and its relationship to the observed clinical effect.

The full text of the announcement from Vedanta is as follows:

Vedanta Biosciences Publishes Phase 2 Results in the Journal of the American Medical Association and Presents at ECCMID

JAMA publication includes in-depth safety and efficacy results from successful Phase 2 study of VE303

Additional analyses support a relationship between VE303 exposure and clinical response via enhanced bacterial colonization, in addition to new evidence of inflammation modulation in treated patients

Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced the publication of Phase 2 study results from its lead program, VE303, in the Journal of the American Medical Association (JAMA), as well as a late-breaker oral presentation at the European Congress of Clinical Microbiology in Infectious Diseases (ECCMID) annual event. The publication includes analyses of safety, efficacy, in preventing recurrence of Clostridioides difficile infection (rCDI), and VE303 strain colonization data from the successfully completed Phase 2 study of VE303. The ECCMID presentation offers more in-depth scrutiny of VE303 strain colonization dynamics and its relationship to the observed clinical effect. Colonization dynamics is analogous to traditional drug pharmacokinetics and refers to the growth and persistence over time of bacterial strain populations in the human gut.

“First-generation microbiome approaches use fecal donor material of variable composition, resulting in inconsistent efficacy outcomes across different clinical studies. In contrast, the results of our VE303 Phase 2 study demonstrate the potential utility of reproducible product candidates that are based on defined bacterial strains grown from clonal cell banks, in a manner analogous to monoclonal antibody production,” said Jeffrey L. Silber, M.D., Chief Medical Officer of Vedanta. “Our targeted approach offers consistent composition and quality attributes, which we believe could provide more consistent clinical benefit. Defined bacterial consortia also avoid the risk of pathogen transfer from donor stool-since there is no donor-and enable greater scalability compared with fecal-derived approaches.”

“Vedanta’s VE303 candidate is based on compelling science that illustrates the role of gut dysbiosis in persistent inflammatory states and the potential for a rationally designed bacterial consortium to restore that balance and support healthy homeostasis of bacterial populations,” said Darrell Pardi, M.D., Chair of the Division of Gastroenterology and Hepatology at the Mayo Clinic in Rochester, Minnesota, and senior author of the JAMA paper. “The notorious difficulty of preventing recurrent CDI creates a large population of patients struggling with the condition, with few therapeutic options. VE303 provides an approach that is designed to address the underlying biology in a novel way. The clinical data to-date have been extremely promising, and we are eager to see future updates on this program as it progresses through the clinic.”

The Journal of the American Medical Association Publication

The JAMA paper, “VE303, a Defined Bacterial Consortium, vs. Placebo for the Prevention of Recurrent Clostridioides difficile Infection: A Randomized Trial,” expands on the results of the Phase 2 study of VE303, which was designed to identify the recommended dose for a Phase 3 study of VE303. The study data confirmed that VE303 prevented recurrent CDI compared with placebo in the study population. The publication announced today includes new analyses of secondary efficacy endpoints, such as CDI recurrence rates at week 24, and stool microbiome endpoints, which included both VE303 strain colonization and gut microbiome diversity.

ECCMID Presentation

This presentation, titled, “An 8-strain defined bacterial consortium promotes microbiota restoration and limits inflammation in patients with recurrent Clostridioides difficile infection (rCDI)” details how VE303 dosing was associated with reduced inflammation within subjects at high risk of rCDI, determined by biomarkers that included a reduction in fecal calprotectin levels and changes in circulating serum cytokines. This analysis demonstrates the possibility that VE303 may provide benefit beyond microbiome restoration in patients with CDI, by limiting pathological inflammation.

About VE303

VE303 is a defined bacterial consortium therapeutic candidate designed for the prevention of recurrent Clostridioides difficile infection (rCDI). It consists of eight strains that were rationally selected using Vedanta’s discovery engine. VE303 is produced from pure, clonal bacterial cell banks, which yield a standardized drug product in powdered form and bypass the need to rely on direct sourcing of donor fecal material of inconsistent composition. Vedanta reported positive topline results in October 2021 from the Phase 2 CONSORTIUM trial, in which VE303 was associated with a 31.7% absolute risk reduction in the rate of recurrence when compared with placebo, representing a greater than 80% reduction in the odds of a CDI recurrence. Vedanta believes VE303 has the potential to become a first-in-class therapeutic based on a defined bacterial consortium. Vedanta Biosciences received a $5.4 million research grant from the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) in 2017 and a contract of up to $81.9 million from Biomedical Advanced Research and Development Authority (BARDA) in 2020 to support clinical studies of VE303. VE303 was granted Orphan Drug Designation in 2017 by the U.S. Food and Drug Administration (FDA) for the prevention of recurrent CDI.

About Vedanta Biosciences

Vedanta Biosciences is leading the development of a potential new category of oral therapies based on defined consortia of bacteria isolated from the human microbiome and grown from pure clonal cell banks. The company’s clinical-stage pipeline includes product candidates being evaluated for the prevention of recurrent C. difficile infection, inflammatory bowel diseases, food allergy, and liver disease. These investigational therapies are grounded in pioneering research by our scientific cofounders – published in leading journals including Science, Nature, and Cell – to identify beneficial bacteria that live symbiotically within the healthy human gut, fight pathogens, and induce a range of potent immune responses. Vedanta Biosciences controls a foundational portfolio of more than 70 patents and has built what it believes is the industry-leading platform for development of defined bacterial consortia drugs. This platform includes one of the largest libraries of bacteria derived from the human microbiome, vast datasets from human interventional studies, proprietary capabilities in consortium design, and end-to-end capabilities for CGMP-compliant manufacturing of oral drug candidates spanning cell banking, fermentation, lyophilization, and fill finish. 

About Defined Bacterial Consortia

Defined Bacterial Consortia are assemblies of bacteria of standardized composition that act cooperatively to exert a therapeutic effect. The constituent strains in each consortium are rationally selected from Vedanta’s extensive in-house strain library, and grown from pure, clonal cell banks using scalable fermentation processes. Each capsule contains precisely controlled compositions and doses of the same live bacterial strains and is formulated for stable oral delivery to the lower gastrointestinal tract. We believe that our targeted approach offers consistent composition and quality attributes, may provide more consistent clinical benefit, limits safety risk, and enables greater scalability compared with fecal-derived approaches.

About PureTech Health

PureTech is a biotherapeutics company dedicated to changing the treatment paradigm for devastating diseases. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech’s Founded Entities, is comprised of 26 therapeutics and therapeutic candidates, including two (Plenity® and EndeavorRx®) that have received both U.S. FDA clearance and European marketing authorization and a third (KarXT) that will soon be filed for FDA approval, as of the most recent update by the Company. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on unique insights in immunology and drug development.

PureTech Health plc (Nasdaq: PRTC, LON:PRTC), a clinical-stage biotherapeutics company, today announced that it has sold 750,000 shares of its Founded Entity, Karuna Therapeutics (“Karuna,” Nasdaq: KRTX), through a block trade executed by Morgan Stanley & Co. LLC for cash consideration of approximately $100 million. PureTech intends to use the proceeds from the Transaction to further the advancement and growth of the Company and will update its cash runway guidance in due course.

Following the Transaction, PureTech continues to hold 1,656,564 of Karuna common stock, which is equal to approximately 5.6% of Karuna’s outstanding shares as of September 30, 2021. PureTech is eligible to receive certain payments from Karuna under its license agreement, including sublicense payments and royalties on any sales of KarXT.

Karuna Therapeutics

Karuna Therapeutics is a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions. Karuna understands there is a need for differentiated and more effective treatments that can help patients navigate the challenges presented by these severe and disabling disorders. Utilizing its extensive knowledge of neuroscience, Karuna is harnessing the untapped potential of the brain in pursuit of novel pathways to develop medicines that make meaningful differences in peoples’ lives.

PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, including inflammatory, fibrotic and immunological conditions, intractable cancers, lymphatic and gastrointestinal diseases and neurological and neuropsychological disorders, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech’s Founded Entities, is comprised of 25 therapeutics and therapeutic candidates, including two that have received both U.S. FDA clearance and European marketing authorization, as of the date of PureTech’s most recently filed Half Year Report and corresponding Form 6-K. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Company’s unique insights into the biology of the brain, immune and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.

PureTech Health plc (Nasdaq: PRTC, LON:PRTC), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, has noted that its Founded Entity, Karuna Therapeutics, Inc. (NASDAQ: KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, announced that results from the EMERGENT-1 Phase 2 clinical trial evaluating KarXT for the treatment of schizophrenia were published in the New England Journal of Medicine (NEJM).

The full text of the announcement from Karuna is as follows:

Karuna Therapeutics Announces New England Journal of Medicine Publication of Data from EMERGENT-1 Phase 2 Trial Evaluating KarXT in Schizophrenia

KarXT demonstrated statistically significant and clinically meaningful improvements in primary and key secondary efficacy measures compared with placebo

Incidences of somnolence, weight gain and extrapyramidal symptoms were similar in KarXT and placebo treatment groups

KarXT is in Phase 3 clinical development for the treatment of psychosis in adults with schizophrenia

Karuna Therapeutics, Inc. (NASDAQ: KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced that results from the EMERGENT-1 Phase 2 clinical trial evaluating KarXT for the treatment of schizophrenia were published in the New England Journal of Medicine (NEJM).

“The publication of the EMERGENT-1 Phase 2 trial results in the peer-reviewed New England Journal of Medicine reinforces earlier clinical and preclinical data that KarXT’s modulation of muscarinic receptor function in the brain improves the symptoms of psychosis in schizophrenia, and underscores the potential of KarXT to offer a novel approach to treating this serious and disabling condition,” said Steve Brannan, M.D., chief medical officer of Karuna Therapeutics and lead author of the manuscript. “These findings support the potential for KarXT to treat symptoms of psychosis in schizophrenia without producing the common problematic side effects of current therapies, such as weight gain and extrapyramidal symptoms. Given these encouraging results, we have advanced KarXT into Phase 3 clinical development in our efforts to provide a meaningful, new, non-dopaminergic treatment option for this serious neuropsychiatric disorder affecting more than 21 million people worldwide.”

The double-blind, placebo-controlled, five-week inpatient EMERGENT-1 Phase 2 trial enrolled 182 adults with an acute exacerbation of schizophrenia. In this trial, a twice-daily, flexible-dose treatment with KarXT demonstrated a statistically significant and clinically meaningful 11.6-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at Week 5, the primary outcome measure of the study, with an effect size of 0.75 (p<0.0001). Results published in NEJM also include data for pre-specified secondary outcome measures. Four of the five pre-specified secondary outcome measures, including PANSS positive symptom subscore, PANSS negative symptom subscore, PANSS Marder negative symptom subscore, and Clinical Global Impression – Severity frequency counts, showed statistically significant reductions following treatment with KarXT compared to placebo at Week 5 (p<0.001).

KarXT was generally well-tolerated, with similar discontinuation rates between KarXT and placebo arms, both overall (20% vs. 21%) and due to treatment-emergent adverse events (2% in both arms). The most common adverse events associated with KarXT, including constipation, nausea, dry mouth, dyspepsia and vomiting, were mild-to-moderate in severity and were not associated with treatment discontinuation. Rates of nausea, vomiting, and dry mouth decreased over the course of the trial, while rates of constipation remained essentially constant. Incidences of somnolence, weight gain and extrapyramidal symptoms, which are common problematic side effects of current antipsychotic therapies, were similar in the placebo and KarXT treatment groups.

“Many people living with schizophrenia have persistent symptoms, experience poor quality of life and impaired ability to function, despite treatment with current antipsychotic drugs,” said Jeffrey Lieberman, M.D., professor and chairman of the Department of Psychiatry, Columbia University, College of Physicians and Surgeons, member of Karuna’s scientific advisory board, and co-author of the manuscript. “The clinical trial results with KarXT highlight its potential to be a differentiated treatment option with a completely new mechanism of action for people living with schizophrenia, offering relief from acute psychotic symptoms without the debilitating side effects associated with the current standard of care.”

About KarXT

KarXT, a proprietary oral modulator of muscarinic cholinergic receptors, is Karuna’s lead product candidate. It combines xanomeline, a novel muscarinic agonist, with trospium, an FDA-approved muscarinic antagonist that does not appreciably cross the blood-brain-barrier, to preferentially stimulate muscarinic receptors in the central nervous system. This novel product candidate, if approved, has the potential to usher in a new treatment paradigm and dramatically impact patients with schizophrenia and other psychotic disorders by providing a differentiated mechanism of action relative to current D2 dopamine and serotonin receptor-targeting antipsychotic drugs.

About Schizophrenia

Schizophrenia is a chronic and often disabling brain condition affecting how a person thinks, feels and behaves. It is estimated to affect more than 21 million people worldwide, and has a young age at onset, typically presenting during late adolescence to early adulthood. Symptoms of schizophrenia generally fall into three categories – positive (delusions, hallucinations, and difficulty organizing and expressing thoughts), negative (difficulty enjoying life and withdrawal from others) and cognitive (deficits in memory, concentration and decision making). Given the nature of these symptoms, schizophrenia can affect all areas of patients’ lives. Many people living with schizophrenia have difficulty finding an effective treatment and continue to experience distressing symptoms. With the help of a dedicated treatment team, it is possible for people with schizophrenia to live full lives. New therapeutic options with different mechanisms of action will enable more patients to find an effective and safe treatment regimen.

About Karuna

Karuna Therapeutics is a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions. At Karuna, we understand there is a need for differentiated and more effective treatments that can help patients navigate the challenges presented by these severe and disabling disorders. Utilizing our extensive knowledge of neuroscience, we are harnessing the untapped potential of the brain in pursuit of novel pathways to develop medicines that make meaningful differences in peoples’ lives.

PureTech Health plc (LON:PRTC), a clinical stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, has announced the appointment of biotech entrepreneur Kiran Mazumdar-Shaw to its board of directors.

Ms Shaw is an industry trailblazer who has spent her career surpassing societal expectations as the founder and chairperson of India’s largest and a leading global biopharmaceutical company, Biocon Limited. Driven by a commitment to provide access to life-saving medicines worldwide, Ms Shaw brings extensive experience in biotherapeutics, strategic leadership, financial and business development and a dedication to improving patients’ lives to PureTech’s board of industry leaders.

“Kiran is a tremendously successful entrepreneur in healthcare and widely recognised as one of the most powerful and influential women in business. She also has a keen interest in improving the health of people around the world,” said Christopher Viehbacher, chairman of PureTech’s board of directors. “Kiran brings a wealth of experience and knowledge to PureTech’s board as we enter this next exciting chapter of growth.”

Ms Shaw is a pioneer of the biotechnology industry in India and a noted philanthropist who has devoted herself to building a sustainable model for delivering top-quality diabetes and cancer care at affordable prices. Since she founded Biocon, she has guided its growth from a leading bioenzymes company of India to a fully integrated and globally recognised multibillion-dollar biopharma company with extensive research efforts in oncology, diabetes and autoimmune disease. In addition to her leadership of Biocon, Ms Shaw chairs the Indian State of Karnataka’s Vision Group on Biotechnology and is on the Advisory Council of the Indian government’s Department of Biotechnology. She serves on the Board of Trustees at Massachusetts Institute of Technology (MIT) and the Keck Graduate Institute (KGI). Ms Shaw is an independent director on the board of Infosys and Narayana Health. She is also an elected international member of the prestigious US National Academy of Engineering (NAE). 

Ms Shaw founded the Mazumdar Shaw Cancer Centre in Bangalore, which focuses on delivering affordable care. She is also the driving force behind the Biocon Foundation, which runs primary healthcare clinics to reach India’s rural poor. Ms Shaw has received multiple industry accolades including being named among Forbes’ World’s 100 Most Powerful Women and World’s Self-Made Women Billionaires, Fortune’s Top 25 Most Powerful Women in Asia-Pacific, TIME Magazine’s 100 Most Influential People in the World, FierceBiotech’s World’s 25 Most Influential People in Biopharma, Scientific American’s The Worldview 100 List of the most influential visionaries, Foreign Policy’s 100 Leading Global Thinkers and the Medicine Maker Power List, a ranking of the 100 most influential people in medicine from across the globe. Ms Shaw was also declared the EY World Entrepreneur of 2020. She is a recipient of several national honours including the Padma Shri (1989) and Padma Bhushan (2005), two of India’s most prestigious civilian awards, the Knight of the Legion d’Honneur, France (2016) and The Order of Australia (2020). Ms Shaw has a graduate degree in zoology from Bangalore University and has earned a master’s degree in malting and brewing from Ballarat College, Melbourne University. She has received honorary doctorates from several institutions globally.

“I am thrilled to join the luminaries on PureTech’s board at a time when the company is poised for rapid growth building on the many successes of recent years,” Ms Shaw said. “With a unique and extremely productive approach towards the development of new medicines, the PureTech team has developed an impressive track record of pioneering new therapies, all of which could be transformational across a number of fields. With exciting programmes within its Wholly Owned Pipeline, PureTech has the potential to be truly disruptive in addressing serious diseases where there is significant need.”

“Kiran is an entrepreneur and visionary who is credited with the conception, development and success of a highly respected and important biopharma enterprise,” said Daphne Zohar, founder and chief executive officer of PureTech. “Her proven track record of entrepreneurial ingenuity and integrity along with her demonstrated business leadership position her as an excellent addition to PureTech’s board of industry leaders. We are excited to work with her as we continue on our growth trajectory.”

On joining the PureTech Health board, Ms Shaw will become a member of the board’s Remuneration and Nomination Committees.

Additional Information

Ms Shaw is independent for the purposes of the UK Corporate Governance Code.

Ms Shaw has served as an independent director of Infosys (NYSE: INFY) since 2014.

Except as set out in this announcement, no disclosure obligations arise under paragraphs (1) to (6) of LR 9.6.13 of the Financial Conduct Authority’s Listing Rules in connection with Ms Shaw’s appointment.

PureTech Health plc (LON:PRTC), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, has noted that its Founded Entity, Akili, today announced that it has received a Conformité Européenne (CE) Mark for EndeavorRx (AKL-T01) as a prescription-only digital therapeutic software intended for the treatment of attention and inhibitory control deficits in paediatric patients with Attention Deficit Hyperactivity Disorder (ADHD). While EndeavorRx is not yet available in Europe, the CE Mark enables Akili to market EndeavorRx in European Economic Area (EEA) member countries. ADHD is one of the most common psychiatric disorders in childhood and nearly five per cent of children in Europe are diagnosed with the disorder.

The CE Mark follows last week’s US Food and Drug Administration (FDA) decision, which made EndeavorRx the first FDA-cleared prescription treatment delivered through a video game and the first game-based therapeutic to be granted marketing authorisation by the FDA for any type of condition. With a near-term focus on launching the EndeavorRx prescription treatment in the US, Akili is exploring expansion opportunities in Europe as part of its global strategy. In March 2019, Akili announced a strategic partnership with Shionogi & Co., Ltd. to develop and commercialise EndeavorRx in Japan and Taiwan.  

The full text of the announcement from Akili is as follows:

Akili Announces CE Mark Approval of EndeavorRx^TM Digital Treatment for Children with ADHD

Approval enables the future marketing of EndeavorRx in European Economic Area member countries

Delivered through a video game experience, EndeavorRx has been studied across five clinical studies including a large, randomised controlled trial

Akili today announced that it has received Conformité Européenne (CE) Mark certification for EndeavorRx (AKL-T01), as a prescription-only digital therapeutic software intended for the treatment of attention and inhibitory control deficits in paediatric patients with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is one of the most common psychiatric disorders in childhood and nearly five per cent of children in Europe are diagnosed with the disorder.

The CE Mark follows last week’s US Food and Drug Administration (FDA) decision, which made EndeavorRx the first FDA-cleared prescription treatment delivered through a video game.

“Following our recent FDA clearance, the CE Mark is another important milestone for Akili,” said Anil Jina, MD, chief medical officer of Akili. “This approval provides a path for the future expansion into Europe and will allow us to offer a new non-drug treatment option to families of children living with ADHD.”

The CE Mark confirms that EndeavorRx meets quality standards for design, manufacture and final inspection. While EndeavorRx is not yet available in Europe, the certification enables Akili to market EndeavorRx in European Economic Area (EEA) member countries. With a near-term focus on launching the EndeavorRx prescription treatment in the US, the company is exploring expansion opportunities in Europe as part of its global strategy. In March 2019, Akili announced a strategic partnership with Shionogi & Co., Ltd. to develop and commercialise EndeavorRx in Japan and Taiwan.

EndeavorRx is built on the Akili Selective Stimulus Management engine (SSME^TM) proprietary technology that presents specific sensory stimuli and simultaneous motor challenges designed to target and activate the neural systems that play a key role in attention function while using adaptive algorithms to personalise the treatment experience for each individual patient.

Clinical Evidence Supporting EndeavorRx

EndeavorRx has been studied across five clinical studies in more than 600 children diagnosed with ADHD, including a prospective, randomised, controlled study published in The Lancet Digital Health journal, which showed EndeavorRx improved objective measures of attention in children with ADHD. After four weeks of EndeavorRx treatment, one-third of children no longer had a measurable attention deficit on at least one measure of objective attention.  Further, about half of parents saw a clinically meaningful change in their child’s day-to-day impairments after one month of treatment with EndeavorRx; this increased to 68% after a second month of treatment. Improvements in ADHD impairments following a month of treatment with EndeavorRx were maintained for up to a month. No serious adverse events have been associated with EndeavorRx in any study to date. Some study participants (9.3%) experienced non-serious treatment-related adverse events with EndeavorRx, including frustration, headache, dizziness, emotional reaction, nausea or aggression.

About Akili

Akili is combining scientific and clinical rigour with the ingenuity of the tech and entertainment industries to challenge the status quo of medicine. Akili has pioneered the development of video game-based digital medicine to improve cognitive function. Akili’s flagship product, EndeavorRx, is a prescription digital treatment to address inattention in children with attention deficit hyperactivity disorder (ADHD). Akili’s patented technology serves as the foundation of its products and is designed to directly activate the networks in the brain responsible for cognitive function. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s treatments are delivered through captivating action video game experiences that drive engagement and compliance. For more information, please visit AkiliInteractive.com.

Daphne Zohar, founder and chief executive officer of PureTech Health said: “Akili’s European marketing authorisation today is an important milestone for families in Europe looking to help their children with ADHD. This is on the heels of the exciting news of Akili’s FDA clearance last week and Gelesis’ receipt of a European CE Mark for Plenity® earlier this month. We are so proud that two products developed from our unique R&D engine have now received marketing authorisation in both the US and Europe.”

PureTech Health plc (LON:PRTC), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, has said that its Founded Entity, Akili, has been granted US Food and Drug Administration (FDA) clearance for EndeavorRxTM (AKL-T01) as a prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD). Delivered through a captivating video game experience, EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. See full indication below. Persistent attention issues have a significant impact on the daily lives of millions of people. Attention impairments are a key component of ADHD for many children.

Daphne Zohar, founder and chief executive officer of PureTech Health said: “The FDA clearance of EndeavorRx is a tremendous milestone as it represents an entirely new class of medicine for children and their families. EndeavorRx is the first digital therapeutic intended to improve symptoms associated with ADHD, and it is also the first game-based therapeutic to be granted marketing authorisation by the FDA for any type of condition. EndeavorRx is now the second product developed from PureTech’s unique R&D model to receive FDA clearance and is further validation of our approach to inventing, identifying, and advancing truly innovative medicines for patients.”

EndeavorRx was granted clearance based on data from five clinical studies in more than 600 children diagnosed with ADHD, including a prospective, randomised, controlled study published in The Lancet Digital Health journal, which showed EndeavorRx improved objective measures of attention in children with ADHD. After four weeks of EndeavorRx treatment, one-third of children no longer had a measurable attention deficit on at least one measure of objective attention. Further, about half of parents saw a clinically meaningful change in their child’s day-to-day impairments after one month of treatment with EndeavorRx; this increased to 68% after a second month of treatment. Improvements in ADHD impairments following a month of treatment with EndeavorRx were maintained for up to a month.

EndeavorRx was reviewed through FDA’s de novo pathway and its clearance creates a new class of digital therapeutics. EndeavorRx is designed to directly target and activate neural systems through the presentation of sensory stimuli and motor challenges to improve cognitive functioning. The EndeavorRx treatment will be available with a prescription to families soon.

EndeavorRx is the second product developed from PureTech Health’s unique R&D model to achieve FDA clearance. In April 2019, Gelesis announced the FDA clearance of PlenityTM as an aid in weight management in overweight and obese adults with a BMI of 25-40 kg/m2, when used in conjunction with diet and exercise. Gelesis also recently received approval to market Plenity in Europe. For the safe and proper use of Plenity, refer to the US Instructions for Use or the EU Instructions for Use.

PureTech Health plc (LON:PRTC), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, has noted that its Founded Entity, Vedanta Biosciences, today announced positive topline data from two Phase 1 studies in healthy volunteers of VE202, the company’s orally-administered live biotherapeutic product (LBP) candidate for inflammatory bowel disease (IBD). The studies showed that VE202 was generally safe and well-tolerated at all doses and demonstrated durable and dose-dependent colonisation. Vedanta expects to begin a Phase 2 study in IBD patients in the next 12 months. The trial was conducted by Janssen Research & Development, LLC; a more complete study dataset and analyses will be submitted to a peer-reviewed journal. Vedanta has regained full rights to the IBD programme and will owe Janssen single-digit royalty payments on net sales of a commercialised product.

Vedanta also announced the receipt of $12 million in additional capital and R&D collaboration funds from new and existing investors, including JSR Corporation, bringing the total Series C/C-2 funding to $71.1 million. Participants in the total Series C round included the Bill & Melinda Gates Foundation, Bristol Myers Squibb, Rock Springs Capital, JSR Corporation, Shumway Capital, Health for Life (Seventure Partners), QUAD Investment Management, SV Investment Corp., Shinhan Investment-Private Equity, Shinhan Capital-Yeollim Partners, Partners Investment Co., Ltd, FC Capital, SymBiosis LLC, and founder PureTech.

Bharatt Chowira, JD, PhD, PureTech’s president and chief of business and strategy, said:

“Vedanta has built an impressive body of evidence that its live biotherapeutic product candidates are safe, well-tolerated and able to modulate the human microbiome in a highly targeted and durable fashion, opening the door for an exciting and entirely novel class of therapeutics. These trial results and the additional Series C funding from leading investors are important milestones for Vedanta and we look forward to the launch of the Phase 2 trial in IBD patients and other advances across the breadth of Vedanta’s pipeline of compelling programmes.”

PureTech Health plc (LON:PRTC), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, has today noted that its Founded Entity, Follica, today announced positive feedback from an End of Phase 2 meeting with the US Food and Drug Administration (FDA) for its lead programme to treat male androgenetic alopecia. The company plans to advance the programme into Phase 3 development this year following the successful safety and efficacy optimisation study announced in December 2019.

Bharatt Chowrira, JD, PhD, president and chief of business and strategy at PureTech, said: “This positive feedback from FDA enables Follica to move forward with its pivotal trial this year. Current treatments for the progressive hair loss caused by androgenetic alopecia are inadequate, and we are pleased with Follica’s progress towards Phase 3 development, bringing us another step closer to a potential new treatment for the millions of people seeking safe, effective, non-surgical treatments to grow new hair.”

Follica plans to launch its Phase 3 programme this year. Overall, approximately 280 patients will be enroled, with efficacy assessed against two co-primary endpoints: visible (non-vellus) hair count and patient-reported outcomes on a pre-established scale. The randomised, controlled, double-blinded studies will be conducted in multiple centers across the US. A maximal use study to further understand the pharmacokinetics of the treatment will be conducted in parallel. The trial design is consistent with feedback from the FDA during the End of Phase 2 meeting.

“In the US alone, 47 million men are affected by progressive hair loss caused by androgenetic alopecia, a condition that is largely unresolved today, leaving many dissatisfied with the current available treatments and looking for a new alternative. Our recent safety and optimisation study points to a new level of effect, enabled by our proprietary approach, which stimulates the growth of new follicles and new hair,” said Jason Bhardwaj, chief executive officer of Follica. “We’re grateful to the FDA for their guidance as we prepare for our pivotal programme, and we look forward to advancing the development of our treatment regimen, which has demonstrated strong potential to address the current need for those who seek treatment for androgenetic alopecia.”

Follica’s approach is based on generating an “embryonic window” in adult scalp cells via a series of short office-based treatments with its proprietary Hair Follicle Neogenesis (HFN) device. The scalp treatments, which last just a few minutes, stimulate stem cells and enable the growth of new hair follicles. A topical drug is then applied to enhance efficacy by growing and thickening new hair follicles and hair on the scalp.

Follica reported topline results from its safety and optimisation study in December 2019. That trial was designed to select the optimal treatment regimen using Follica’s proprietary HFN device in combination with a topical drug and successfully met its primary endpoint. The selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire trial population and a substantially improved outcome with the optimal treatment regimen. Additionally, a prespecified analysis comparing the 44% change in visible (non-vellus) hair count to a 12% historical benchmark set by approved pharmaceutical products established statistical significance (p = 0.005).

In addition to the safety and optimisation study, Follica has validated its approach in prior clinical studies using prototype HFN devices with different treatment parameters and therapeutic compounds. Follica’s translational work builds on research by George Cotsarelis, MD, who isolated and characterised the expression pattern of stem cells from a critical region of the follicle. An expert in epithelial stem cell biology, Dr Cotsarelis is chair of the department of dermatology at the University of Pennsylvania and a co-founder of Follica.

PureTech Health is a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, including intractable cancers, lymphatic and gastrointestinal diseases, central nervous system disorders and inflammatory and immunological diseases, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech’s Founded Entities, is comprised of 23 product candidates and one product that has been cleared by the US Food and Drug Administration (FDA). All of the underlying programmes and platforms that resulted in this pipeline of product candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Company’s unique insights into the biology of the brain, immune and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.

PureTech Health plc (LON:PRTC), a clinical stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, has noted that its Founded Entity, Gelesis, today announced that it has received approval to market Plenity™, a novel weight loss treatment, in Europe. Gelesis received a Conformité Européenne (CE) mark for Plenity as a class III medical device indicated for weight loss in overweight and obese adults with a Body Mass Index (BMI) of 25-40 kg/m2, when used in conjunction with diet and exercise. Gelesis will now be able to market Plenity throughout the European Economic Area and in other countries that recognise the CE mark. Gelesis previously received clearance for Plenity from the US Food and Drug Administration and plans to bring Plenity to the US first, where it is now available to a limited extent while the company ramps up its commercial operations and inventory for a broad launch in 2021.

Eric Elenko, PhD, chief innovation officer at PureTech Health, said: “This is an important milestone for Gelesis and for the millions of adults across Europe who are seeking to manage their weight. We look forward to continued progress from Gelesis’ novel hydrogel platform and to the broad launch of Plenity across of the world.”

About Plenity™

Plenity™ is an oral, non-systemic, superabsorbent hydrogel which has received FDA clearance as an aid in weight management in overweight and obese adults with a BMI of 25-40 kg/m2, when used in conjunction with diet and exercise. It is made by cross-linking two naturally derived building blocks, modified cellulose and citric acid, that create a three-dimensional matrix. Plenity particles rapidly absorb water in the stomach and homogenously mix with ingested foods. Rather than forming one large mass, it creates thousands of small individual gel pieces with the elasticity (firmness) of solid plant-based foods (e.g., vegetables) without caloric value. The Plenity hydrogel increases the volume and elasticity of the stomach and small intestine contents and induces a feeling of fullness and satiety. Once it arrives in the large intestine, the hydrogel is partially broken down by enzymes and loses its three-dimensional structure along with most of its absorption capacity. The released water is reabsorbed in the large intestine, and the remaining cellulosic material is eliminated through the body’s natural digestive processes. Plenity is considered a medical device because it achieves its primary intended purpose through mechanical modes of action consistent with mechanobiology constructs.

PureTech Health plc (LON:PRTC) have today announced that Daphne Zohar, founder and chief executive officer, will present at the 19th Annual Virtual Needham Healthcare Conference on Wednesday, 15 April, at 1:30 PM EDT. The conference is being held virtually, and a webcast of the presentation will be available on the Investors Relations section of the PureTech website at https://www.puretechhealth.com/reports-presentations.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, including intractable cancers, lymphatic and gastrointestinal diseases, central nervous system disorders and inflammatory and immunological diseases, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech’s Founded Entities, is comprised of 23 product candidates and one product that has been cleared by the US Food and Drug Administration (FDA). All of the underlying programmes and platforms that resulted in this pipeline of product candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Company’s unique insights into the biology of the brain, immune and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.

PureTech Health plc (LON:PRTC), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, today announced its annual results for the year ended 31 December 2019. The following information represents select highlights from the full Report, which is available on the Investor Relations section of the PureTech Health website at http://puretechhealth.com/reports-presentations.

Webcast and conference call details

Members of the PureTech management team will host a conference call at 9.00 EDT / 14.00 GMT today, 9 April, to discuss these results. A live webcast and presentation slides will be available on the investors section of PureTech’s website () under the Reports and Presentations tab. To join the conference call please dial:

United Kingdom: 0800 640 6441

United Kingdom (Local): 020 3936 2999

USA (Local): 1 646 664 1960

All other locations: +44 20 3936 2999

Access code: 007425

Participants should log on approximately 10 minutes in advance to download slides and ensure proper setup to receive the webcast. For those unable to listen to the call live, a replay will be available on the PureTech website.

Cash Position

·    As of 31 December 2019, the Company reports PureTech Level Cash Reserves of $120.6 million² along with $200.9 million in proceeds from the 22 January 2020 sale of 2.1 million Karuna common shares, totalling PureTech Level Pro-forma Cash Reserves of $321.5 million¹

·    In 2019, PureTech’s Founded Entities raised $666.8 million³ in financing transactions, of which 622.8 million (93.4 per cent) came from third parties.

Continued growth and expansion of Wholly Owned Pipeline

In 2019, PureTech grew and strengthened its Wholly Owned Internal Pipeline, which is centred on the lymphatic system and related immunological disorders. This pipeline includes one clinical-stage product candidate for the potential treatment of a range of conditions involving fibrosis, inflammation and impaired lymphatic flow (LYT-100), two preclinical product candidates for intractable cancers (LYT-200 and LYT-210) and three discovery platforms. Key developments include the following:

·    In July 2019, PureTech announced the acquisition of a clinical‑stage product candidate LYT-100 (deupirfenidone) for the potential treatment of a range of conditions of fibrosis, inflammation and impaired lymphatic flow, including lymphoedema, idiopathic pulmonary fibrosis (IPF), acute lung injury and inflammation, unclassifiable interstitial lung disease (uILD), focal segmental glomerulosclerosis (FSGS) and radiation-induced fibrosis.

·    In the March 2020 post-period, PureTech announced the initiation of a multiple ascending dose study to evaluate the safety, tolerability and pharmacokinetic profile of LYT-100 in healthy participants. Results are expected in 2020 and may enable the initiation of a proof-of-concept study in people with breast cancer-related, upper limb secondary lymphoedema and an additional fibrosis and inflammation indication in 2020.

·    In April 2019, PureTech announced a collaboration agreement with Boehringer Ingelheim (BI) to evaluate the feasibility of applying PureTech’s lymphatic targeting technology to advance certain of BI’s immuno-oncology product candidates. Under the terms of the agreement, PureTech is eligible to receive up to $26 million in upfront payments, research support and preclinical milestones, and is eligible to receive more than $200 million in development and sales milestones, in addition to royalties on product sales.

·    PureTech presented preclinical data supporting its first-in-class, fully-human monoclonal antibodies targeting galectin-9 (LYT-200) and immunosuppressive γδ1 (gamma delta-1) T cells (LYT-210) at the American Association for Cancer Research (AACR) Annual Meeting in April 2019 and the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2019. PureTech is developing LYT-200 and LYT-210 to treat intractable cancers, including colorectal cancer (CRC), cholangiocarcinoma and pancreatic cancer, along with other relevant cancers and immunological disorders.

·    In June 2019, PureTech expanded to new corporate headquarters and labs in Boston’s Seaport District to advance and accelerate development of the Company’s Wholly Owned Pipeline. In addition to the programmes mentioned above (LYT‑100, LYT‑200, LYT-210 and the lymphatic targeting chemistry platform), PureTech’s Wholly Owned Pipeline includes a milk exosome platform to traffic therapeutics via the lymphatic system and a meningeal lymphatics platform for treating neurodegenerative diseases.

Strong clinical, regulatory and financial progress across the Founded Entities

PureTech’s Founded Entities have made significant progress advancing 20 product candidates, 13 of which are clinical stage. Key developments include the following:

Karuna

·    In June 2019, Karuna announced the successful pricing of its initial public offering (IPO) of common stock on the Nasdaq Global Market under the symbol “KRTX.” Gross proceeds were approximately $102.6 million, including the full exercise of the underwriters’ over-allotment option. Karuna previously completed an $82.1 million Series B round in April 2019, including the issuance of $7.1 million in shares upon conversion of debt into equity.

·    In November 2019, Karuna announced that KarXT achieved the primary endpoint of its Phase 2 clinical trial for the treatment of acute psychosis in patients with schizophrenia. In the clinical trial, KarXT demonstrated a statistically significant and clinically meaningful 11.6 point mean reduction in total Positive and Negative Syndrome Scale (PANSS) score compared to placebo (p<0.0001) and also demonstrated good overall tolerability. A statistically significant reduction in the secondary endpoints of PANSS-Positive and PANSS-Negative scores were also observed (p<0.001). Karuna plans to hold an end-of-Phase 2 meeting with the FDA in the second quarter of 2020, and pending the outcome of that meeting, anticipates advancing KarXT into a Phase 3 clinical trial by the end of 2020.

·    In November 2019, Karuna completed a follow-on offering of 2,600,000 shares of its common stock, with gross proceeds of approximately $250 million.

·    In the January 2020 post-period, PureTech sold 2.1 million of its Karuna shares for a cash consideration of approximately $200 million. PureTech intends to use the proceeds from this transaction to fund its operations and growth for the foreseeable future and to further expand and advance its clinical-stage Wholly Owned Pipeline. Following the sale, PureTech continues to hold 5,295,397 shares of Karuna common stock (20.3% as of 13 March 2020) and has a right to royalty payments as a percentage of net sales.

Gelesis

·    In April 2019, Gelesis received clearance from the FDA for its first product, Plenity™⁵ (Gelesis100), a prescription aid for weight management in adults with a Body Mass Index (BMI) of 25-40 kg/m², when used in conjunction with diet and exercise. Gelesis initiated a Plenity early experience programme in the United States in the second half of 2019 and anticipates Plenity will be available by prescription in the United States in the second half of 2020, with a broad launch in early 2021. Gelesis also filed Plenity for marketing authorisation in Europe in February 2019. Important safety information regarding Plenity can be found at www.myplenity.com.

·    In December 2019, Gelesis announced a partnership with Ro, a leading US telehealth provider, to support the US commercialisation of Plenity, which is expected in the second half of 2020, with a broad launch in early 2021.

·    In 2019, Gelesis secured nearly $100 million in new capital and non-dilutive grants to support the US commercialisation of Plenity, including over $84 million announced in December 2019 and $10.6 million announced in April 2019.

·    In 2019, Gelesis and its research collaborators presented clinical data supporting its proprietary hydrogel platform. Additional safety and efficacy data for Plenity was presented at ObesityWeek, and clinical data for a GS500 prototype in patients with chronic idiopathic constipation (CIC) was presented at Digestive Disease Week. Gelesis also presented preclinical research at the Endocrine Society Annual Meeting and The International Liver Congress suggesting that GS300 may restore gut barrier function after damage as well as prevent the harmful effects of a high-fat diet on the liver and associated metabolic disorders.

·    In the March 2020 post-period, Gelesis was named to Fast Company’s annual list of the World’s Most Innovative Companies for 2020, which honours the businesses making the most profound impact on both industry and culture.

Akili

·    In the January 2020 post-period, Akili announced that a study achieved its primary endpoint evaluating the effects of lead product candidate AKL-T01 in children with Attention Deficit Hyperactivity Disorder (ADHD) when used with and without stimulant medication.

·    In December 2019, Akili presented the results from a trial of AKL-T03 as a potential treatment for cognitive impairments adjunct to anti-depressant medication in adults with Major Depressive Disorder (MDD) at the 58th Annual Meeting of the American College of Neuropsychopharmacology. In the trial, AKL-T03 demonstrated a statistically significant improvement in sustained attention compared to control. AKL-T03 is designed to improve specific cognitive functions and may play a complementary role to antidepressants in the holistic treatment of MDD.

·    Akili is currently actively pursuing FDA clearance for AKL-T01. Clearance for AKL-T01 has not yet been granted, and Akili continues to work with the FDA in an effort to make the product available for children living with ADHD.

·    In March 2019, Akili entered into a strategic partnership with Shionogi & Co., Ltd. for the development and commercialisation of two of Akili’s digital medicine product candidates, AKL-T01 and AKL-T02 (in development for children with ADHD and Autism Spectrum Disorder, respectively), in Japan and Taiwan. Under the terms of the agreement, Akili will build and own the platform technology and received upfront payments totalling $20 million, with potential milestone payments for Japan and Taiwan commercialisation of up to an additional $105 million in addition to substantial royalties.

Follica

·    In December 2019, Follica announced topline results from its safety and efficacy optimisation study of its lead candidate to treat hair loss in male androgenetic alopecia. The study was designed to select the optimal treatment regimen using Follica’s proprietary device in combination with a topical drug and successfully met its primary endpoint. The selected treatment regimen demonstrated a statistically significant 44% improvement of non-vellus (visible) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). The initiation of a Phase 3 registration study in male androgenetic alopecia is expected in 2020.

Vedanta

·    In December 2019, Vedanta Biosciences announced the initiation of a first-in-patient clinical trial of its immuno-oncology candidate, VE800, in patients with select types of advanced or metastatic cancer. The trial will evaluate clinical activity of VE800 in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo® (nivolumab). Topline results are anticipated in 2021.

·    In July 2019, Vedanta Biosciences announced the enrolment of the first patient in its Phase 1/2 clinical study of its product candidate VE416 for food allergy. Topline results are expected in 2021.

·    In January 2019, Vedanta Biosciences published seminal research in Nature that underlies Vedanta’s proprietary oral immuno-oncology product candidate, VE800.

·    In May 2019 and September 2019, Vedanta Biosciences announced extensions to its Series C financing round, bringing the total capital raised in the round to $62.1 million.

·    In December 2019, Vedanta Biosciences announced that it had been awarded a $5.8 million grant from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to advance its VE707 programme targeting multi-drug resistant organisms.

·    In May 2019, Vedanta Biosciences presented expanded data from its Phase 1a/1b study of VE303, the company’s product candidate for high-risk Clostridioides difficile infection (CDI) at Digestive Disease Week.

Alivio

·    In January 2019, Alivio Therapeutics entered into a partnership focused on non-opioid approaches to pain management with Imbrium Therapeutics L.P. to advance ALV-107, a non-opioid treatment being developed for interstitial cystitis/bladder pain syndrome (IC/BPS), through clinical development. Under the terms of the agreement, Alivio is eligible to receive up to $14.75 million in upfront and near-term license exercise payments and is eligible to receive royalties on product sales and over $260 million in research and development milestones. Alivio retains the rights of its inflammation targeting platform for a broad range of internal and partnering applications.

Vor

·    In February 2019, Vor completed a $42.9 million Series A financing round to advance its lead cell therapy product candidate for the treatment of acute myeloid leukaemia (AML) and to further build its pipeline to treat haematologic malignancies.

·    In May 2019, the scientific founder of Vor Biopharma, Dr Siddhartha Mukherjee, and key individuals from his lab at Columbia University, published a preclinical proof-of-concept study supporting Vor’s lead product candidate, VOR33, and its technology platform for treating cancer via engineered haematopoietic stem cells (HSCs) in the Proceedings of the National Academy of Sciences (PNAS).

·    In the January 2020 post-period, Vor held a pre-IND meeting with the FDA to gather important feedback to assemble the data package necessary for a potential IND filing.

Sonde

·    In April 2019, Sonde completed a $16 million Series A financing round, including the issuance of $6 million in shares upon conversion of debt into equity, to expand the capability of its voice-based technology platform for monitoring and diagnosing mental and physical medical conditions across additional health conditions and device types and to fund commercialisation activities.

·    Sonde has collected voice data from over 40,000 subjects as a part of the ongoing validation of its platform, and it has also initiated research and development to expand its proprietary technology into Alzheimer’s disease and respiratory and cardiovascular disease, as well as other health and wellness conditions.

Entrega

·    Entrega continued to advance its platform for the oral delivery of biologics, vaccines and other drugs that are otherwise not efficiently absorbed when taken orally, progressing a broad range of prototypes in additional preclinical studies as part of its collaboration with Eli Lilly.

Commenting on the annual results, Daphne Zohar, founder and chief executive officer of PureTech said:

“2019 was an unprecedented year, and our unique model for drug development and value creation was validated in many ways. Across our Wholly Owned Pipeline and our Founded Entities, we now have one FDA cleared product and 23 product candidates, all of which potentially address major healthcare needs. 14 of these candidates are clinical-stage, and we anticipate at least seven readouts and ten initiations over the course of 2020. We are very proud of this remarkable clinical progress.

“We also saw the value of our innovation recognized when the positive results from Karuna’s (Nasdaq: KRTX) Phase 2 study of KarXT, a candidate [co-]invented by PureTech, generated over several hundred million dollars in value for PureTech. We were able to monetise a portion of that stake in January 2020, resulting in $200.9 million in proceeds and extending our cash runway into the first quarter of 2024, while still maintaining 20.3% share and the right to receive royalties.

“The team at PureTech has consistently been united behind a shared goal: to make a difference in human health by bringing truly novel and differentiated therapeutics to patients where great needs exist. I can think of no greater need at the present date than the global SARS-CoV-2 (COVID-19) pandemic, which we have been monitoring closely. Our mission to develop new classes of medicines for serious and underserved diseases will continue to be driven by our internal capabilities and collaborations with our network of leading experts in an effort to improve care for vulnerable populations affected by immunological diseases, severe infections, neurological disorders and intractable cancers, among other serious disorders.”

Across our organisation, we have taken measures to ensure the safety and well-being of our employees and do our part as global citizens, while continuing to execute against our business objectives. As of 8 April, we do not believe that any of our ongoing work has been materially delayed, but we do anticipate the strain on the global healthcare system may eventually impact timelines, as healthcare providers rightly prioritise acute, near-term needs. We are so grateful to those on the front lines, and we have donated lab supplies and personal protective equipment (PPE) to local hospitals to aid in their heroic efforts.

“This has been an incredibly productive year, as well as a tremendous display of our commitment to developing transformational treatments for devastating diseases and building value for our shareholders. I am grateful to our team, our Board, and our wide network of collaborators who all share our vision, and I thank our shareholders for their continued support as we enter this exciting new phase of PureTech’s development.”

PureTech also notes that Bennett Shapiro, MD, co-founder of PureTech, non-executive director and member of the R&D Committee, will not stand for re-election at the Company’s 2020 Annual General Meeting. As a co-founder, Dr Shapiro has played a critical role in driving the scientific and clinical direction of PureTech since the genesis of the Company. When he led R&D at Merck, he emphasised the external R&D model that Merck and other large pharma companies subsequently embraced, and Dr Shapiro’s guidance was vital to the formation of PureTech’s innovation model and shaping what it is today. His strategic scientific guidance has contributed to the advancement of all of the Company’s current programs, and he has played a particularly noteworthy role in driving successes across Karuna, Gelesis, Vedanta and Akili.

Dr Shapiro will continue to serve on PureTech’s R&D Committee, which is also comprised of:

·      Dennis Ausiello, MD: Massachusetts General Hospital (MGH), chief emeritus of medicine and director of the Center for Assessment Technology and Continuous Health (CATCH); Harvard Medical School, Jackson distinguished professor of clinical medicine

·      Robert Horvitz, PhD: Nobel laureate; MIT, David H. Koch professor of biology; Howard Hughes Medical Institute investigator; MGH neurobiologist (neurology)

·      Raju Kucherlapati, PhD: Harvard Medical School, Paul C. Cabot professor of genetics and a professor of medicine

·      John LaMattina, PhD: Pfizer, former president of Global Research and Development

·      Robert Langer, ScD: MIT, David H. Koch Institute professor of biology

“It has been an honour to serve as a founding member of PureTech’s Board and to contribute to the Company’s unique, highly-productive and mission-oriented enterprise,” said Dr Shapiro. “Together we have opened up new insights and pathways for improving human health, and I look forward to continuing those advancements in my role on the R&D Committee.”

PureTech Health today released its Annual Report for the year ended 31 December 2019. In compliance with the Financial Conduct Authority’s Listing Rule 9.6.3, the following documents have today been submitted to the National Storage Mechanism and will shortly be available for inspection at http://www.morningstar.co.uk/uk/NSM.

·    Annual Report and Accounts for the year ended 31 December 2019; and

·    Notice of 2020 Annual General Meeting.

Printed copies of these documents together with the Form of Proxy will be posted to shareholders. Copies are also available electronically on the Investor Relations section of the Company’s website at http://puretechhealth.com/reports-presentations.

PureTech’s 2020 Annual General Meeting (AGM) will be held on 11 June 2020 at 11.00 EDT / 16.00 BST at PureTech’s headquarters, which is located at 6 Tide Street, Boston, Massachusetts, United States. Please note that in light of the spread of COVID-19 and recent travel restrictions imposed by a number of governments, it will not be possible for the Directors to travel to the United Kingdom. Further, the UK Government has published compulsory measures prohibiting, among other things, public gatherings of more than two people. These “Stay at Home” measures were passed into law in England and Wales with immediate effect on 26 March 2020. The Company has therefore decided to hold the AGM in the United States where most of the Directors are resident. The Company continues to closely monitor the evolving situation in respect of COVID-19 and its forthcoming AGM.

The health and welfare of the Company’s shareholders, as well as its employees and partners, is the Company’s number one priority. The AGM therefore will be kept as concise and efficient as possible, with social interactions kept to a minimum and additional hygiene requirements in force at the meeting and venue.

We appreciate that a number of our shareholders are not resident or located in the United States. Given the recent Government guidance not to travel unless it is essential, we ask shareholders to participate in the AGM by submitting any questions in advance and voting via proxy rather than attending in person. As such, any specific questions on the business of the AGM and resolutions can be submitted ahead of meeting by e-mail to [email protected] (marked for the attention of Mr. Stephen Muniz).

Shareholders are also encouraged to submit their votes by proxy regardless of whether they expect to attend in person, and to do so no later than 16.00 BST on Tuesday 9 June 2020. Details of how to appoint a proxy are set out in the notice of AGM. Shareholders are reminded of their right to appoint the Chairman of the AGM, or any other person, as their proxy to attend the meeting and vote on their behalf.

PureTech is monitoring the rapidly evolving situation and will refuse entry to the AGM where necessary to ensure the safety of attendees and compliance with governmental or regulatory orders. The Company will keep shareholders updated of any changes to the current plans for the AGM. Please visit the Company’s website at www.puretechhealth.com for the most up to date information.

Notes

(1)   PureTech Level Pro-forma Cash Reserves is an alternative performance measure (APM) which includes the PureTech Level Cash Reserves of $120.6 million and the $200.9 million in proceeds from the 22 January 2020 sale of 2.1 million Karuna common shares. PureTech Pro-forma Cash Reserves is therefore considered to be more representative of the Corporate’s cash available for the year 2020 and beyond to advance product candidates within the full breadth of its operations.

(2)   PureTech Level Cash Reserves represent cash balances and short-term investments held at PureTech Health LLC, PureTech Management, Inc., PureTech Health PLC, PureTech Securities Corporation of $112.0 million for the year ended 2019 and the internal pipeline of $8.6 million for the year ended 2019, all of which are wholly-owned entities of PureTech, excluding cash balances and short-term investments of Controlled Founded Entities. The balance excludes the $200.9 million in proceeds from the 22 January 2020 sale of 2.1 million Karuna common shares.

(3)   Funding figure includes private equity financings, public offerings or grant awards. Funding figure excludes upfront payments and future milestone considerations received in conjunction with partnerships and collaborations such as those with Roche, Boehringer Ingelheim, Imbrium Therapeutics L.P., Shionogi & Co., Ltd. or Eli Lilly.

(4)   Unless the context specifically indicates otherwise, references in this report to “Founded Entities” refer to the entities that PureTech founded and in which PureTech continues to hold equity. While PureTech maintains ownership of equity interests in its Founded Entities, the Company does not, in all cases, maintain control over these entities (by virtue of (i) majority voting control and (ii) the right to elect representation to the entities’ board of directors) or direct the management and development efforts for these entities. Consequently, not all such entities are consolidated in the financial statements. Where PureTech maintains control, the entity is referred to as a Controlled Founded Entity in this report and is consolidated in the financial statements. Where PureTech does not maintain control, the entity is referred to as a Non-Controlled Founded Entity in this report and is not consolidated in the financial statements. As of 31 December 2019, Controlled Founded Entities include Alivio Therapeutics, Inc., Follica, Incorporated, Entrega, Inc., Vedanta Biosciences, Inc. and Sonde Health, Inc., and Non-Controlled Founded Entities include Akili Interactive Labs, Inc., Gelesis, Inc., Karuna Therapeutics, Inc., Vor Biopharma Inc. and, for all periods prior to December 18, 2019, resTORbio, Inc.

(5)   Plenity has been cleared by the United States Food and Drug Administration (US FDA) as an aid to weight management in adults with a Body Mass Index (BMI) of 25-40 kg/m², when used in conjunction with diet and exercise. Important Safety Information: Plenity is contraindicated in patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatine, or titanium oxide. Plenity may alter the absorption of medications. Read Sections 6 and 8.3 of the Instructions for Use carefully. Avoid use in patients with the following conditions: oesophageal anatomic anomalies, including webs, diverticuli, and rings; suspected strictures (such as patients with Crohn’s disease); or complications from prior gastrointestinal (GI) surgery that could affect GI transit and motility. Use with caution in patients with: active GI conditions such as gastro-oesophageal reflux disease (GERD), ulcers, or heartburn. Overall, the most common treatment related adverse events (TRAEs) were GI-related TRAEs with 38 per cent of adults in the Plenity group and 28 per cent of adults in the placebo group experiencing a GI-related TRAE. The overall incidence of AEs in the Plenity group was no different than the placebo group. Rx Only. For the safe and proper use of Plenity, refer to the Instructions for Use.

(6)   Nature of announcement: The financial information set out in this Annual Results Release does not constitute the Company’s statutory accounts for 2018 or 2019. Any references to page numbers in this announcement are to pages within the Annual Report and Accounts. Statutory accounts for the year ended 31 December 2019 have been reported on by the Independent Auditor and will be delivered to the Registrar when due.

(7)   Forward looking statements: This Annual Results Release and the Annual Report and Accounts contain 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 management section. 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 Annual Results Release. Except as required by law, regulatory requirement, the Listing Rules and the Disclosure Guidance and Transparency Rules, 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.

Letter from the Chairman

2019 was a year of validation and transformation for PureTech. PureTech has a long track record of identifying and incubating highly innovative technologies to address significant unmet need, then building highly talented and passionate teams around each programme while making remarkably efficient use of resources. What really drives value for investors and patients alike are positive clinical outcomes, regulatory progress and the validation of third-party investors – and PureTech has had an incredible series of such results this past year.

One such example is Karuna. The team identified a portfolio medicine from Eli Lilly with compelling efficacy signals in schizophrenia and Alzheimer’s disease suggesting it could outstrip existing therapies. But, unable to resolve the tolerability profile, Eli Lilly abandoned the drug. PureTech came up with a novel, scientifically elegant way to offset the mechanism causing the tolerability problems without reducing efficacy. Karuna’s successful proof-of-concept studies showed that PureTech’s patience and persistence paid off. Karuna subsequently completed an IPO in July 2019 and, following positive Phase 2 results in November 2019, became a company worth approximately $2 billion¹. Now seeking to validate its Phase 2 findings in a Phase 3 trial, there is new hope for patients with schizophrenia, who have had very few new therapeutic options for decades. At the same time, tremendous value has been created for PureTech investors.

The Karuna results were outstanding in our industry but this was only one of many positive developments for PureTech in 2019.

Among the many metrics that validate PureTech’s novel approach to drug development, this one stands out as particularly striking: 23 product candidates are now in development across PureTech’s Founded Entities and Wholly Owned Pipeline, including 14 in the clinic. Another point of pride: Gelesis’ Plenity™², a highly differentiated approach for weight management, is moving rapidly toward commercialisation after receiving clearance from the US Food and Drug Administration in April 2019.

Across PureTech’s Founded Entities are novel therapeutic approaches to address cancer, schizophrenia, severe infection, ADHD, inflammatory bowel disease and other serious disorders. Tellingly, all these potential breakthroughs originated from research conducted by PureTech’s internal team together with its global network of advisers and collaborators. We have built a truly unparalleled ecosystem for identifying pioneering ideas, subjecting them to rigorous evaluation and then moving the best forward.

This track record of success makes me even more excited about our focused work to advance our Wholly Owned Pipeline. In these programmes, we aim to translate our expertise in the Brain-Immune-Gut axis into novel therapeutics for lymphatic and immunological disorders and intractable cancers. It’s a thrill to be in the clinic with our most advanced wholly-owned programme, LYT-100, which we are initially evaluating for a range of immune and fibrotic disorders, including the potential treatment of lymphoedema, a serious and often disfiguring disease for which there are no approved drugs. LYT-100 has the potential to be developed for a range of fibrotic conditions in addition to lymphoedema. Also advancing quickly through our pipeline are two novel antibody candidates for hard-to-treat cancers. Our proprietary lymphatic targeting platform and our meningeal discovery platform are also building value through substantial partnerships with top-notch collaborators, such as Boehringer Ingelheim, and through our own internal R&D efforts.

PureTech is able to take on such an ambitious scope of work due to strong leadership from the executive team and thoughtful guidance from our wonderful board. We are all committed to creating value as we bring transformational medicines to patients living with substantial need. I extend a sincere thank you to all our shareholders for supporting and enabling our continued growth and to my fellow board members for their thoughtful and strategic guidance. I am proud to be part of the PureTech Health team and I look forward to continued success in 2020.

Christopher Viehbacher

Chairman

(1)      Based on market cap of $1.96 billion on 31 December 2019.

(2)      Plenity has been cleared by the United States Food and Drug Administration (US FDA) as an aid to weight management in adults with a Body Mass Index (BMI) of 25-40 kg/m², when used in conjunction with diet and exercise. Important Safety Information: Plenity is contraindicated in patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatine, or titanium oxide. Plenity may alter the absorption of medications. Read Sections 6 and 8.3 of the Instructions for Use carefully. Avoid use in patients with the following conditions: oesophageal anatomic anomalies, including webs, diverticuli, and rings; suspected strictures (such as patients with Crohn’s disease); or complications from prior gastrointestinal (GI) surgery that could affect GI transit and motility. Use with caution in patients with: active GI conditions such as gastro-oesophageal reflux disease (GERD), ulcers, or heartburn. Overall, the most common treatment related adverse events (TRAEs) were GI-related TRAEs with 38 per cent of adults in the Plenity group and 28 per cent of adults in the placebo group experiencing a GI-related TRAE. The overall incidence of AEs in the Plenity group was no different than the placebo group. Rx Only. For the safe and proper use of Plenity, refer to the Instructions for Use.

PureTech Health plc (LON:PRTC) has today announced that Daphne Zohar, founder and chief executive officer, will present at the 9th Annual SVB Leerink Global Healthcare Conference in New York on Tuesday, 25 February at 9:00 AM EST. A webcast of the presentation will be available at http://puretechhealth.com/investors under the Reports and Presentations tab.

About PureTech Health

PureTech is a clinical stage biotechnology company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, including intractable cancers, lymphatic and gastrointestinal diseases, central nervous system disorders, and inflammatory and immunological diseases, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech’s affiliates, is comprised of 23 product candidates and one product that has been cleared by the US Food and Drug Administration (FDA). All of the underlying programmes and platforms that resulted in this pipeline of product candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Company’s unique insights into the biology of the brain, immune, and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.

PureTech Health plc (LON: PRTC), a clinical stage biotechnology company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, today announces that it has sold 2.1 million shares of its affiliate Karuna Therapeutics (NASDAQ: KRTX) for a cash consideration of approximately $200 million to Goldman Sachs & Co. LLC. PureTech intends to use the proceeds from the Transaction to fund its operations and growth for the foreseeable future and to further expand and advance its clinical stage, wholly owned pipeline.

Following the Transaction, PureTech continues to hold 5,295,397 shares of Karuna common stock, which is equal to 20.4% of Karuna’s outstanding shares, and has a right to royalty payments on net sales of any commercialised product covered by a license granted by PureTech to Karuna.

Daphne Zohar, founder and chief executive officer of PureTech said:

“As a founder of Karuna and co-inventor of the KarXT program, we are delighted to continue to be a major shareholder of Karuna going forward. With multiple efficacy studies validating both xanomeline and KarXT, Karuna is well-positioned to be a major player in the neuropsychiatry field. We are particularly enthusiastic about the potential for patients to have a new and differentiated treatment option for schizophrenia and related diseases. This is an area that – despite a large market where branded therapies have been blockbuster products – has been lacking innovation for decades. We have a high degree of confidence in the team, who have an impressive track record, to unlock the full potential of the growth opportunities that may be available to them.

“This sale of a minority of our holdings in Karuna provides us with additional cash resources to fund our operational growth, including our rapidly growing wholly owned pipeline, for the foreseeable future. We believe that this realisation of value provides additional validation of PureTech’s overall business strategy.”

The Transaction constitutes a class 2 transaction for the purposes of the UK Financial Conduct Authority’s Listing Rules.

About Karuna

Karuna is a clinical-stage biopharmaceutical company committed to developing and delivering first-in-class therapies with the potential to transform the lives of people with CNS disorders – which remain among the most disabling and potentially fatal disorders worldwide. Galvanized by the understanding that today’s neuropsychiatric and pain management patients deserve better, Karuna’s mission is to harness the untapped potential of the brain’s complex biology in pursuit of novel therapeutic pathways that will advance the standard of care. For more information, please visit karunatx.com.

About PureTech Health

PureTech is a clinical stage biotechnology company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, including intractable cancers, lymphatic and gastrointestinal diseases, central nervous system disorders, and inflammatory and immunological diseases, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech’s affiliates, is comprised of 23 product candidates and one product that has been cleared by the US Food and Drug Administration (FDA). All of the underlying programmes and platforms that resulted in this pipeline of product candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Company’s unique insights into the biology of the brain, immune, and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.

PureTech Health plc (LON: PRTC) has today noted that its affiliate Follica today announced topline results from its safety and efficacy optimisation study to treat hair loss in male androgenetic alopecia. The study was designed to select the optimal treatment regimen using Follica’s proprietary device in combination with a topical drug and successfully met its primary endpoint. The selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire study population and a substantially improved outcome seen with the optimal treatment regimen. Additionally, a prespecified analysis comparing the 44% change in visible (non-vellus) hair count to a 12% historical benchmark set by approved pharmaceutical products1 established statistical significance (p = 0.005). The initiation of a Phase 3 registration study is expected in the first half of 2020.

Joseph Bolen, PhD, chief scientific officer at PureTech Health, said:

“Currently, there are only two approved drugs on the market for the treatment of androgenetic alopecia, both of which have only demonstrated a 12% increase of non-vellus hair count over baseline. There remains a significant need for safe, effective, non-surgical treatments to grow new hair, and we believe the Follica data demonstrate strong promise as a potential new standard of care for the millions of people hoping to address their androgenetic alopecia.”

Follica’s proprietary in-office treatment regimen combines targeted scalp disruption using the Follica Hair Follicle Neogenesis (HFN) device, with a topical on-market drug to create and grow new hair follicles. In blinded head-to-head bench testing, the Follica HFN device significantly outperforms available skin disruption devices on key treatment parameters important for hair follicle neogenesis. The topline results from this clinical study, together with three previously conducted clinical trials, provide important validation for Follica’s proprietary approach for the treatment of androgenetic alopecia.

The full text of the announcement from Follica is as follows:

Follica Announces Positive Topline Data from Clinical Study in Male Androgenetic Alopecia

Demonstrated 44% improvement over baseline of visible (non-vellus) hair count, a well-established hair growth measure (p value < 0.001)

Study met primary endpoint and identified optimal frequency and number of treatments with Follica’s proprietary device in combination with a topical drug after three months of treatment

Phase 3 registration study initiation expected in first half of 2020

Follica, Inc. a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other medical indications, today announced topline results from its safety and efficacy optimisation study to treat hair loss in male androgenetic alopecia. The study was designed to select the optimal treatment regimen using Follica’s proprietary device in combination with a topical drug and successfully met its primary endpoint. The selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire study population and a substantially improved outcome seen with the optimal treatment regimen. Additionally, a prespecified analysis comparing the 44% change in visible (non-vellus) hair count to a 12% historical benchmark set by approved pharmaceutical products1 established statistical significance (p = 0.005). The initiation of a Phase 3 registration study is expected in the first half of 2020.

Follica’s proprietary in-office treatment regimen combines targeted scalp disruption using the Follica Hair Follicle Neogenesis (HFN) device, with a topical on-market drug to create and grow new hair follicles. Based on clinical testing over several years, Follica has optimised a range of important parameters to enable the therapeutic effect. Specifically, Follica’s proprietary HFN device is designed to create new hair follicles and hair on the scalp for the treatment of androgenetic alopecia. In blinded head-to-head bench testing, the Follica HFN device significantly outperforms available skin disruption devices on key treatment parameters important for hair follicle neogenesis. The topline results from this clinical study, together with three previously conducted clinical trials, provide important validation for Follica’s proprietary approach for the treatment of androgenetic alopecia.

“The topline results of this study represent an exciting potential new treatment to address a persisting challenge in our field: identifying a successful approach to growing new hair in patients who have lost hair,” said Ken Washenik, MD, PhD, president and medical director of Bosley Medical Group, clinical faculty of dermatology at NYU School of Medicine and senior medical advisor to Follica. “We believe Follica is the first to bring forward an approach to grow new hair that is now supported by strong human efficacy data. The compelling data generated by the company thus far indicate that Follica’s approach could be a promising new option for the approximately 90 million people who are eligible for the treatment of androgenetic alopecia in the United States alone.”

The study involved a less than five-minute in-office experimental scalp procedure using the proprietary Follica HFN device designed to stimulate hair follicle growth and evaluated the optimal frequency and number of treatments across three arms. Follica’s approach is based on generating an “embryonic window” in adults via a series of skin disruptions, stimulating stem cells and causing new hair follicles to grow. This process of hair follicle neogenesis involves minimal daily interruption and is enhanced through the application of a topical compound as part of the treatment regimen following HFN.

“We are very pleased with the results of this study and are especially excited to demonstrate the strength of Follica’s proprietary device and treatment regimen,” said Jason Bhardwaj, chief executive officer of Follica. “Our data show that clinical results differ significantly based on the approach to disrupting the skin and confirm Follica’s proprietary treatment paradigm is optimised for new hair growth. We look forward to initiating the pivotal trial.”

“Some of my past life was spent trying to stop hair from growing, but I’m equally enthusiastic to have been involved in helping advance and optimise George Cotsarelis’ key discovery that shows promise for creating new hair,”

said R. Rox Anderson, MD, PhD, professor of dermatology at Harvard Medical School, director of the Massachusetts General Hospital Laser Center and scientific advisor to Follica, who conceived and developed many of the non-scarring treatments now widely used in medical and aesthetic care. These include laser treatments for birthmarks, microvascular and pigmented lesions, tattoo and permanent hair removal, as well as cryolipolysis (Coolsculpting®).

The safety and efficacy optimisation study was an endpoint-blinded, randomised, controlled study designed to establish therapeutic parameters for Follica’s proprietary device in combination with a topical drug. The study consisted of 48 men aged 18-40 who had moderate grades of androgenetic alopecia (Hamilton Norwood III-IV). The optimal frequency and number of treatments was studied across three treatment arms. The regimen was well tolerated across all treatment arms with no reported serious adverse events. No adverse events were related to device treatment. A single non-severe event (headache) was determined to be related to use of the drug and is in line with minor side effects seen from treatment with the approved drug alone.

In addition to the safety and efficacy optimisation study, Follica has proof-of-concept data from prior clinical studies using prototype devices with different treatment parameters and therapeutic compounds. Follica’s translational work builds on an important basic discovery by George Cotsarelis, MD, chair of the department of dermatology at the University of Pennsylvania and a co-founder of Follica.

About Androgenetic Alopecia

Androgenetic alopecia represents the most common form of hair loss in men and women, with an estimated 90 million people who are eligible for treatment in the United States alone. Only two drugs, both of which have demonstrated a 12% increase of non-vellus hair count over baseline for their primary endpoints, are currently approved for the treatment of androgenetic alopecia1. The most effective current approach for the treatment of hair loss is hair transplant surgery, comprising a range of invasive, expensive procedures for a subset of patients who have enough donor hair to be eligible. As a result, there remains a significant need for safe, effective, non-surgical treatments to grow new hair.

About Follica

Follica is a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other medical indications. Founded by PureTech Health (LSE: PRTC), a co-inventor of the current platform, and a group of world-renowned experts in hair follicle biology and regenerative medicine, Follica’s experimental treatment platform has been shown to stimulate the development of new hair follicles and hair in three previously conducted clinical studies. The company’s proprietary treatment is designed to induce an embryonic window via a device with optimised parameters to initiate hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process is enhanced through the application of a topical compound. Follica completed an optimisation trial and a Phase 3 registration study in androgenetic alopecia is expected to begin in the first half of 2020. Follica’s technology is based on work originating from the University of Pennsylvania that has been further developed by Follica’s internal program. Follica’s extensive IP portfolio includes IP exclusively licensed from the University of Pennsylvania as well as Follica-owned IP.

About PureTech Health

PureTech is a clinical stage biotechnology company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, including intractable cancers, lymphatic and gastrointestinal diseases, central nervous system disorders, and inflammatory and immunological diseases, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech’s affiliates, is comprised of 23 product candidates and one product that has been cleared by the US Food and Drug Administration (FDA). All of the underlying programmes and platforms that resulted in this pipeline of product candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Company’s unique insights into the biology of the brain, immune, and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.

PureTech Health plc (LON: PRTC), a clinical stage biotechnology company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, has today noted that its affiliate Gelesis today announced it has secured $84.6 million in new capital. In total, Gelesis has obtained nearly $100 million this year to support the US launch of PlenityTM.

“We are pleased that Gelesis continues to attract impressive investor interest as they prepare for the US launch of Plenity,”
said Eric Elenko, PhD, chief innovation officer at PureTech Health.

The full text of the announcement from Gelesis is as follows:

Gelesis Secures Over $84 Million in New Capital to Support Commercialisation of PLENITY™

Vitruvian Partners leads a $63.4 million equity round, complemented by $21.2 million in new, non-dilutive grant funding and loans to further support commercialisation efforts

Gelesis, a biotechnology company developing a novel hydrogel platform technology to treat obesity and other chronic diseases related to the gastrointestinal (GI) tract, today announced it secured $84.6 million in new capital. In total, Gelesis has obtained nearly $100 million this year to support the US launch of PlenityTM.

This latest round of equity funding totalling $63.4 million was led by private equity firm Vitruvian Partners and included other investors. The proceeds from the financing will be used primarily to support the US launch of Plenity in the second half of 2020.

“We are delighted to begin this partnership with Vitruvian, whose mission of driving rapid growth and change across industries is very much aligned with our approach to launching this first-of-its-kind product that could potentially make a difference in the lives of people struggling with excess weight,” said Yishai Zohar, founder and chief executive officer of Gelesis. “With this new capital, we are well-positioned to enhance our strategic launch initiatives and leverage our early commercial experience as we prepare for large scale commercial availability of Plenity in the US.”

Based upon the Gelesis’ proprietary manufacturing facility location, the company was also awarded a grant of $12.9 (€11.7) million from the European Regional Development Fund (ERDF), regulated by the Puglia Region of Italy. This builds on the $10.6 (€9.4) million grant announced in April 2019 and brings the total non-dilutive funds secured this year to $23.5 million. The company also further enhanced its financial flexibility by entering into a long-term, low interest $8.3 million loan agreement.

PureTech Health plc (LON: PRTC) a clinical stage biotechnology company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, has today noted that its affiliate, Vedanta Biosciences, has been awarded a $5.8 million grant for its VE707 programme targeting multi-drug resistant infections. The grant was awarded by Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership dedicated to accelerating early development in antibacterial R&D to address the rising global threat of drug-resistant bacteria. Vedanta Biosciences is eligible for $3.5 million in further funding upon completion of specific milestones.

Bharatt Chowrira, JD, PhD, president and chief of business and strategy at PureTech Health said:

“Increasingly the human microbiome is being colonised by dangerous bacteria and other microorganisms that have developed resistance to antimicrobial drugs, mainly through poor global stewardship of antibiotics. This grant from CARB-X recognises Vedanta’s unique platform and advanced understanding of the human gut microbiome for developing live biotherapeutic products with the potential to modulate the intestinal microbiome to address a range of significant human diseases and health issues, including drug-resistant pathogens.”

PureTech Health plc (LON: PRTC), a clinical-stage biotechnology company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, has announced that Daphne Zohar, founder and chief executive officer, will present at the Jefferies 2019 London Healthcare Conference on Wednesday, 20th November, at 3:20PM GMT. A webcast of the presentation will be available at http://puretechhealth.com/investors under the Reports and Presentations tab.

About PureTech

PureTech Health is a clinical stage biotechnology company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, including intractable cancers, lymphatic and gastrointestinal diseases, central nervous system disorders, and inflammatory and immunological diseases, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech’s affiliates, is comprised of 24 product candidates and one product that has been cleared by the US Food and Drug Administration (FDA). All of the underlying programmes and platforms that resulted in this pipeline of product candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Company’s unique insights into the biology of the brain, immune, and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.