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.
· 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:
· 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.
· 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.
· 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.
· 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.
· 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.
· 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.
· 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.
· 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 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 firstname.lastname@example.org (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.
(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.
(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.