Predict your next investment

CONSUMER PRODUCTS & SERVICES | Veterinary Care Services

See what CB Insights has to offer

Stage

Acquired | Acquired

About Capstar

Capstar is a brand of oral flea medicine for cats and dogs. On July 16, 2020, Capstar was acquired by PetIQ for $95 million.

Capstar Headquarter Location

Greenfield, Indiana, 46140,

United States

Latest Capstar News

PureTech Health plc : – Half-Year Report

Aug 24, 2021

PureTech Health plc 333.5 08/23 08/17 08/24/2021 | 02:01am EDT Message : *Required fields Strong capital base and cash runway expected into the first quarter of 2025, with PureTech level cash and cash equivalents of $409.7 million1 and consolidated cash and cash equivalents of $439.8 million2 as of June 30, 2021 Continued advancement of PureTech’s Wholly Owned Programs, with two Phase 2 and four Phase 1 clinical trials underway and key preclinical data published in peer-reviewed journals for two of PureTech’s four lymphatic and inflammation platforms Significant developments across the Founded Entities, Vor’s Nasdaq listing, Gelesis’ merger agreement with Capstar SPAC to become publicly-traded, Karuna’s progress with its Phase 3 program for KarXT in schizophrenia and Akili’s scaled U.S. commercialization of EndeavorRx® Company to host a webcast and conference call today at 9:00am EDT / 2:00pm BST PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”) today announces its half-yearly results for the six months ended June 30, 2021. 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 Entities3, is comprised of 25 therapeutics and therapeutic candidates, including 15 that are clinical stage and two that have received both U.S. Food and Drug Administration (FDA) clearance and European marketing authorization. The following information will be filed on Form 6-K with the United States Securities and Exchange Commission and is also available at https://investors.puretechhealth.com/financials-filings/reports . 1. PureTech Level Cash and Cash equivalents as of June 30, 2021 represent cash and cash equivalents held at PureTech Health plc and its wholly-owned subsidiaries only. Please refer to the Financial Review section of this report for additional detail. 2. Consolidated Cash and cash equivalents as of June 30, 2021 represent cash and cash equivalents of $439.8 million as shown on the Consolidated Statements of Financial Position. 3. 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’ boards of directors) or direct the management and development efforts for these entities. Consequently, not all such entities are consolidated in the Company’s 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 Company’s financial statements. As of June 30, 2021, PureTech’s Controlled Founded Entities included Follica Incorporated, Vedanta Biosciences, Inc., Sonde Health, Inc. and Entrega, Inc., and PureTech’s Non-Controlled Founded Entities included Gelesis, Inc., Karuna Therapeutics, Inc., Akili Interactive Labs, Inc. and Vor Biopharma Inc. Relevant ownership interests for Founded Entities were calculated on a diluted basis (as opposed to a voting basis) as of June 30, 2021, including outstanding shares, options and warrants, but excluding unallocated shares authorized to be issued pursuant to equity incentive plans. Vedanta ownership was calculated on a diluted basis as of July 16, 2021. For each of Karuna and Vor, ownership was calculated on an outstanding voting share basis as of June 30, 2021. Webcast and conference call details Members of the PureTech management team will host a conference call at 9:00am EDT / 2:00pm BST today, August 24, 2021, to discuss these results. A live webcast and presentation slides will be available on the investors section of PureTech’s website under the Events and Presentations tab. To join by phone, please dial: United Kingdom: 0800 640 6441 United Kingdom (Local): 020 3936 2999 United States: 1 855 9796 654 United States (Local): 1 646 664 1960 All other locations: +44 20 3936 2999 Access code: 499281 For those unable to listen to the call live, a replay will be available on the PureTech website. Commenting on PureTech’s half-yearly results, Daphne Zohar, Founder and Chief Executive Officer of PureTech, said: “This has been another strong period for PureTech. We have made exciting clinical progress across both our Wholly Owned Pipeline and our Founded Entities, and substantial financial momentum leaves us in an excellent position to continue delivering on our promise to patients and to creating value for shareholders. “Our Wholly Owned Programs have rapidly accelerated and grown, with six therapeutic candidates now in development to potentially address serious patient needs. LYT-100 is being evaluated in two ongoing Phase 2 clinical trials in Long COVID and breast cancer-related lymphedema, and we have also initiated three additional Phase 1 clinical trials to further inform the development of LYT-100 in these indications as well as in idiopathic pulmonary fibrosis (IPF). We look forward to sharing our potentially registration-enabling development plans in IPF in the fourth quarter of this year following discussion with the FDA and other regulatory bodies. Additionally, the Phase 1 portion of a Phase 1/2 trial of LYT-200 for the potential treatment of difficult-to-treat solid tumors is expected to read out in the fourth quarter of this year, and – pending the results – a Phase 2 trial is planned to evaluate LYT-200 both alone and in combination with BeiGene’s tislelizumab or chemotherapy. “Our Founded Entities have also had a productive period. Gelesis’ merger agreement with Capstar Special Purpose Acquisition Corp., upon completion, will make it the third of PureTech’s Founded Entities to become publicly traded. Along with Vor (Nasdaq:VOR) and Karuna (Nasdaq:KRTX), these three entities will have a combined value of over $5.4 billion as of June 30th, including the expected valuation of Gelesis following the completion of its Capstar merger. In addition to our equity holdings across all of our Founded Entities, we are also due royalties on potential product sales from Gelesis, Karuna and Follica. Royalties due to us from each of those programs could potentially be worth as much as - or more than - our equity in each program, depending on the extent of future product sales. “Our pioneering hub and spoke model of developing new medicines has yielded 25 therapeutics and therapeutic candidates to date with clinical development success rates that significantly outperformed biopharma industry averages. The common theme underlying all of these programs has been to start with a tremendous patient need and to identify or invent a solution based on signals of human efficacy and clinically validated biology. In many cases, this approach has enabled us to advance a new candidate with a significantly de-risked profile, resulting in what we believe are differentiated treatments for devastating diseases. “I remain proud of and energized by the progress our team has made this year, and I look forward to the many milestones ahead throughout the remainder of 2021 and into 2022. “ Operational Highlights Wholly Owned Programs4 PureTech’s team, network and insights and expertise in the biology of the brain, immune and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis have enabled the rapid advancement and growth of the Company’s Wholly Owned Programs. Focused on the lymphatic system and related immunological and inflammatory disorders, PureTech’s Wholly Owned Pipeline currently consists of six therapeutic candidates including: LYT-100 (deupirfenidone), a clinical therapeutic candidate that the Company is pursuing for inflammatory and fibrotic conditions and disorders of lymphatic flow; LYT-200, a clinical therapeutic candidate targeting a foundational immunosuppressor, galectin-9, that the Company is developing for the potential treatment of a range of cancer indications; LYT-210, a preclinical therapeutic candidate targeting immunomodulatory gamma delta-1 T cells that the Company is developing for a range of cancer indications; LYT-300 (oral allopregnanolone), a preclinical therapeutic candidate derived from PureTech’s GlyphTM platform that the Company is developing for a range of neurological and neuropsychological conditions; LYT-500, a preclinical, orally-administered therapeutic candidate derived from PureTech’s AlivioTM platform that the Company is developing for inflammatory bowel disease (IBD); and LYT-503/IMB-150, a preclinical therapeutic candidate derived from PureTech’s Alivio platform that is being advanced in collaboration with Imbrium Therapeutics as a potential non-opioid treatment for interstitial cystitis or bladder pain syndrome (IC/BPS). PureTech’s Wholly Owned Programs also include four lymphatic and inflammation platforms: Glyph – a synthetic lymphatic targeting chemistry platform – and OrasomeTM – an oral biotherapeutics platform – both of which leverage the absorption of dietary lipids to traffic therapeutics via the lymphatic system, Alivio – an inflammation-targeting immunomodulation platform for the potential treatment of a range of chronic and acute inflammatory disorders – and a meningeal lymphatics research program to develop potential treatments for neurodegenerative and neuroinflammatory diseases. Key developments and progress during the period across PureTech’s Wholly Owned Programs include: In the first half of 2021, PureTech progressed two ongoing Phase 2 clinical trials of LYT-100 including 1) a global, randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the efficacy, safety and tolerability of LYT-100-COV in adults with Long COVID5 respiratory complications and related sequelae. Topline results from this trial are expected by the end of 2021, and 2) a Phase 2a proof-of-concept study of LYT-100-LYMPH in patients with breast cancer-related, upper limb secondary lymphedema. Topline results from this trial are expected in 2022. PureTech has also initiated a three-month, open-label extension of the LYT-100-COV Phase 2 trial in adults with Long COVID respiratory complications and related sequelae who completed the first portion of the trial. The primary endpoint of the extension trial is to assess the longer-term safety and tolerability of LYT-100-COV through up to 182 days of treatment. In the first half of 2021, PureTech initiated three additional Phase 1 clinical trials of LYT-100 to explore further the pharmacokinetic (PK), dosing and tolerability in healthy volunteers. One of these trials is an extension of the previously completed multiple ascending dose (MAD) study of LYT-100 and is designed to determine the maximum tolerated dose of LYT-100 in healthy volunteers. Results from these trials are anticipated in the fourth quarter of 2021 and are expected to provide additional data to inform future clinical development of LYT-100 across multiple indications. In April 2021, PureTech announced the formation of its Clinical Advisory Board for IPF and other progressive fibrosing interstitial lung diseases (PF-ILDs). Comprised of physicians and researchers with deep expertise in the clinical development of novel therapies in PF-ILDs, the Clinical Advisory Board will work closely with PureTech as it advances LYT-100-ILD. PureTech is planning the trial design that will potentially enable registration of LYT-100-ILD for the treatment of IPF and potentially other PF-ILDs. PureTech expects to provide additional guidance in the fourth quarter of 2021, following discussion with regulatory agencies and which may also be informed by additional ongoing Phase 1 studies of LYT-100. In the August 2021 post-period, PureTech presented the results of the Phase 1 multiple ascending dose and food effect study of LYT-100 at the virtual European Respiratory Society International Congress. In the July 2021 post-period, PureTech announced a clinical trial and supply agreement with an affiliate of BeiGene, Ltd. to evaluate BeiGene’s tislelizumab, an anti-PD-1 monoclonal antibody, in combination with PureTech’s LYT-200, an investigational monoclonal antibody (mAb) targeting galectin-9, for the potential treatment of difficult-to-treat solid tumors that are associated with poor survival rates. Under the terms of the agreement, PureTech will maintain control of the LYT-200 program, including global R&D and commercial rights, and BeiGene has agreed to supply tislelizumab for use in combination with LYT-200 for the planned study. LYT-200 is currently being evaluated as a single agent in the Phase 1 portion of a Phase 1/2 clinical trial. The primary objective of the Phase 1 portion of the trial is to assess the safety and tolerability of escalating doses of LYT-200 to identify a dose to carry forward into the Phase 2 portion of the trial. The Phase 1 portion will also assess the PK and pharmacodynamic (PD) profiles of LYT-200. Results from the Phase 1 portion of the study are anticipated in the fourth quarter of 2021. Pending these results, PureTech intends to initiate the Phase 2 expansion cohort portion of the trial, which is designed to evaluate LYT-200 both alone and in combination with BeiGene’s tislelizumab or chemotherapy. In the first half of 2021, PureTech continued to advance LYT-300, its most advanced Glyph candidate, towards the clinic. LYT-300 is an oral form of allopregnanolone, an IV version of which is approved by the FDA and administered over 60 hours, and PureTech believes LYT-300 may be applicable to a range of neurological and neuropsychological conditions. PureTech expects to initiate a clinical trial of LYT-300 by the end of 2021. The initial objective of the clinical program is to characterize the safety, tolerability and PK of orally administered LYT-300 in a Phase 1 clinical trial in healthy volunteers. This study may also explore the impact of LYT-300 on ß-EEG, a marker of GABAA target engagement. Data from this study will be used to define a potential range of future studies and planned indications. In February 2021, a preclinical proof-of-concept study for the Glyph technology was published in the Journal of Controlled Release. The results demonstrate the ability of this platform to directly target gut lymphatics with an orally dosed small molecule immunomodulator. In June 2021, PureTech announced its acquisition of the remaining 22 percent of shares outstanding in its Founded Entity, Alivio Therapeutics (Alivio). Alivio’s therapeutic candidates, in development for inflammatory disorders including IBD, have been integrated into PureTech’s Wholly Owned Pipeline, and the underlying Alivio technology platform, which is designed to enable inflammation-targeted immunomodulation for the potential treatment of a range of chronic and acute inflammatory disorders, and related undisclosed anti-inflammatory candidates, have been added to PureTech’s discovery programs. The lead candidate from within the Alivio technology platform is LYT-500, which is a preclinical, orally-administered therapeutic candidate in development for IBD. PureTech expects preclinical proof-of-concept data for LYT-500 in the first half of 2022. In the August 2021 post-period, PureTech announced that Imbrium exercised a license option under the companies’ research and development collaboration agreement to develop PureTech’s LYT-503/IMB-150 for the potential treatment of IC/BPS. In connection with the option exercise, PureTech received an upfront payment of $6.5 million and is eligible to receive up to $53 million in additional development milestone payments for this program as well as royalties on product sales. An IND application for LYT-503/IMB-150 is planned to be filed in early 2022. In April 2021, PureTech announced the publication of preclinical research in Nature around its meningeal lymphatics research program, suggesting that restoring lymphatic flow in the brain, either alone or in combination with passive immunotherapies such as antibodies directed at amyloid beta, has the potential to address a range of neurodegenerative diseases including Alzheimer's and Parkinson's diseases and the associated neuroinflammation. The work also uncovered a link between dysfunctional meningeal lymphatics and damaging microglia activation in Alzheimer's disease, which potentially impairs the efficacy of passive immunotherapies such as amyloid beta-targeting antibodies. This suggests another route by which restoring healthy drainage patterns could improve clinical outcomes. In the first half of 2021, PureTech also progressed its Orasome technology platform, which is a novel programmable and scalable approach for the oral administration of nucleic acids and other biologics. Preclinical proof-of-concept data is expected in 2021. In the August 2021 post-period, PureTech announced the appointment of Julie Krop, M.D., as Chief Medical Officer. Dr. Krop will oversee all clinical development, regulatory, CMC, and medical affairs for the Company’s advancing Wholly Owned Pipeline. 4. References in this report to “Wholly Owned Programs” refer to the Company’s six therapeutic candidates (LYT-100, LYT-200, LYT-210, LYT-300, LYT-500 and LYT-503/IMB-150), four lymphatic and inflammation platforms and potential future therapeutic candidates and platforms that the Company may develop or obtain. References to “Wholly Owned Pipeline” refer to LYT-100, LYT-200, LYT-210, LYT-300, LYT-500 and LYT-503/IMB-150. On July 23, 2021, Imbrium Therapeutics exercised its option to license LYT-503/IMB-150 pursuant to which it is responsible for all future development activities and funding for LYT-503/IMB-150. 5. Long COVID is a term being used to describe the emerging and persistent complications following the resolution of COVID-19 infection, also known as post-acute COVID-19 syndrome (PACS). Founded Entities In 2021, PureTech’s Founded Entities have made significant progress advancing 19 therapeutics and therapeutic candidates, of which two have been cleared for marketing by the FDA and granted marketing authorization in the European Economic Area (EEA), and 13 are clinical stage. PureTech’s Founded Entities have also made significant progress during the period, including: Founded Entities in which PureTech has a controlling interest or the right to receive royalties, in order of development stage Gelesis, Inc. (PureTech’s ownership as of June 30, 2021 was 19.2%. PureTech’s ownership will be updated following completion of the Capstar merger announced in the July 2021 post-period. PureTech also has a right to royalty payments as a percentage of net sales.) − In the July 2021 post-period, Gelesis and Capstar Special Purpose Acquisition Corp. (NYSE: CPSR) (Capstar) a special purpose acquisition company sponsored by affiliates of Capstar Partners, LLC and certain private funds managed by PIMCO announced that they have entered into a definitive business combination agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on the New York Stock Exchange (NYSE) under the symbol “GLS.” The transaction is expected to close in the fourth quarter of 2021, subject to the satisfaction of certain closing conditions. − In the first half of 2021, Gelesis made progress towards the full U.S. commercial launch of Plenity® 6 in the second half of 2021. Gelesis also plans to seek FDA input on the requirements for potentially expanding the Plenity label for treating adolescents. − In May 2021, Gelesis presented a scientific poster at the American Association of Clinical Endocrinology (AACE) 2021 Annual Virtual Meeting. The post-hoc analysis showed that treatment for weight management with Plenity decreased a marker for liver fibrosis (the NAFLD fibrosis score) compared to placebo. − In April 2021, Gelesis announced the appointment of marketing executive Jane Wildman to its Board of Directors. Ms. Wildman has extensive experience as a board member, President and Chief Marketing Officer across Fortune-25, mid-sized and start-up companies, including having spent over 25 years at Procter & Gamble. Karuna Therapeutics, Inc. (PureTech ownership: 8.1%; PureTech also has a right to royalty payments as a percentage of net sales) − In the August 2021 post-period, Karuna announced all Phase 3 trials in the EMERGENT clinical program evaluating KarXT (xanomeline-trospium) for the treatment of psychosis in adults with schizophrenia are enrolling. Karuna anticipates reporting topline data from the Phase 3 EMERGENT-2 trial in mid-2022. − In the August 2021 post-period, Karuna also announced it is on track to initiate the Phase 3 ARISE trial evaluating the safety and efficacy of KarXT compared to placebo as an adjunctive treatment in adults with schizophrenia who have an inadequate response to their current antipsychotic therapy in the second half of 2021. − In June 2021, Karuna announced data from its completed Phase 1b trial evaluating the safety and tolerability of KarXT in healthy elderly volunteers, which followed a preliminary analysis of data from the first two cohorts in the trial announced earlier this year. The results suggest that KarXT can be administered to elderly volunteers at doses which achieve xanomeline blood levels similar to those reported in the Phase 2 EMERGENT-1 trial in adults with schizophrenia while maintaining a favorable tolerability profile. Data from the trial also suggest that a lower dose ratio of trospium to xanomeline, compared to the ratios used in Phase 1 trials in healthy adult volunteers and in the Phase 2 EMERGENT-1 trial evaluating KarXT in adults with schizophrenia, was better tolerated by healthy elderly volunteers. Karuna plans to initiate a Phase 2 trial evaluating KarXT in dementia-related psychosis in the first half of 2022. − In March 2021, Karuna completed a follow-on public offering of its common stock, from which it received gross proceeds of $269.8 million, before deducting the underwriting discounts and commissions and other estimated offering expenses. − In February 2021, Karuna 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). − In February 2021, PureTech sold one million shares of Karuna common stock for cash consideration of approximately $118 million. Follica, Incorporated (PureTech ownership: 76.0%. PureTech also has a right to royalty payments as a percentage of net sales) − In January 2021, Follica announced the appointment of two leaders in aesthetic medicine and dermatology to its Board of Directors. Tom Wiggans, former CEO of Dermira, joined as Executive Chairman with over 30 years of experience leading biopharmaceutical companies from the start-up stage to global commercialization, and Michael Davin, former CEO of Cynosure, joined as an Independent Director with over 30 years of experience in the medical device industry. Vedanta Biosciences, Inc. (PureTech ownership: 41.4%) − In June 2021, Vedanta presented additional results from a Phase 1 study in healthy volunteers of VE202, Vedanta’s 16-strain defined bacterial consortium candidate for IBD, at the International Human Microbiome Consortium Congress 2021 (IHMC). The data summarized the long-term safety and colonization dynamics of the 16-strain version of VE202 in 31 healthy volunteers. Vedanta plans to move this consortium forward to a Phase 2 study in patients with mild to moderate ulcerative colitis in the second half of 2021. The study will be partially funded with proceeds from a $25 million investment from Pfizer, as part of the Pfizer Breakthrough Growth Initiative, which was announced in January 2021. − In the July 2021 post-period, Vedanta announced the closing of a $68 million Series D financing and provided a pipeline update. As part of the announcement, Vedanta stated it is nearing completion of Stage 1 of an open-label Phase 1 study to evaluate the safety and initial clinical activity of VE800 in combination with Bristol Myers Squibb’s Opdivo® (nivolumab) in 54 patients across select types of advanced or metastatic cancers. To date, VE800 has demonstrated an acceptable safety and tolerability profile, though the observed response rates did not meet the prespecified criteria to expand into the next stage of the study. Vedanta plans to present the results at a future medical conference and will continue work to identify cancer settings and patient populations that might benefit from microbiome manipulation with its defined bacterial consortia. − In February 2021, Vedanta announced the appointment of Mark Mullikin as Chief Financial Officer. Mr. Mullikin brings 25 years of experience raising and deploying capital for life sciences companies, and most recently held leadership roles in finance and investor relations at publicly-traded Editas Medicine and Novartis. Sonde Health, Inc. (PureTech ownership: 44.6%) − In the July 2021 post-period, Sonde announced that it will collaborate with leading chipmaker Qualcomm Technologies, Inc. (Qualcomm) to optimize use of Sonde’s vocal biomarker technology on the flagship and high-tier Qualcomm® Snapdragon™ 888 and 778G 5G Mobile Platforms to help bring native, machine learning-driven vocal biomarker capabilities to mobile and IoT devices globally. The optimization has the potential to unlock several native health screening and monitoring applications on up to the hundreds of millions of mobile devices that use these Snapdragon mobile platforms. Entrega, Inc. (PureTech ownership: 72.9%) − Entrega continued to advance its platform for the oral administration of biologics, vaccines and other drugs that are otherwise not efficiently absorbed when taken orally. As part of its collaboration with Eli Lilly, Entrega has continued to investigate the application of its peptide administration technology to certain Eli Lilly therapeutic candidates. The partnership has been extended into 2021. Founded Entities in which PureTech has an equity interest, in order of development stage: Akili Interactive Labs, Inc. (PureTech ownership: 23.4%) − In May 2021, Akili announced the closing of a $160 million combined equity and debt financing. With the completion of the oversubscribed Series D financing, the funding is expected to accelerate commercialization of EndeavorRx 7, enable expansion of core technologies to treat acute and chronic cognitive disorders and drive further research and development of potential new digital therapeutics. − In April 2021, Akili announced collaborations with Weill Cornell Medicine, New York-Presbyterian Hospital and Vanderbilt University Medical Center to evaluate Akili digital therapeutic AKL-T01 as a treatment for patients with cognitive dysfunction following COVID-19 (also known as “COVID brain fog”). Under each collaboration, Akili will work with research teams at each institution to conduct two separate randomized, controlled clinical studies evaluating AKL-T01’s ability to target and improve cognitive functioning in COVID-19 survivors who have exhibited a deficit in cognition. − In March 2021, Akili announced the publication of full data from a multi-site open-label study (the STARS Adjunct study) evaluating the impact of EndeavorRx (AKL-T01) on symptoms and functional impairments in children with attention-deficit/hyperactivity disorder (ADHD). Statistically significant improvement was demonstrated in all predetermined endpoints of the study, which included parent and clinician ratings of children’s ADHD symptoms and related impairments in daily life. The results have been published in the international peer-reviewed journal, Nature Digital Medicine. − In the July 2021 post-period, Akili introduced new gaming features and functionalities to its EndeavorRx treatment. Akili is releasing these new gameplay features as it expands its go-to market approach to bring EndeavorRx to families and healthcare professionals at scale. − In the August 2021 post-period, Akili and Australian digital health company TALi® (ASX:TD1), completed an agreement for Akili to license TALi's technology designed to address early childhood attention impairments. The companies plan to work together to execute clinical trials of the TALi technology in pediatric ADHD in the United States and pursue FDA regulatory clearance. Under the terms of the agreement, Akili will lead potential U.S. commercialization and roll-out. Vor Biopharma Inc. (PureTech ownership: 8.6%) − In February 2021, Vor announced the pricing of its initial public offering of common stock on the Nasdaq Global Market under the symbol “VOR”. The aggregate gross proceeds to Vor from the offering were approximately $203.4 million, before deducting the underwriting discounts and commissions and other offering expenses payable by Vor. − In January 2021, Vor announced that the FDA had accepted Vor’s investigational new drug application (IND) application for VOR33. − In June 2021, Vor announced it has entered into a multi-year strategic collaboration and license agreement with Abound Bio to research both single- and multi-targeted CAR-T treatments to be used in combination with Vor’s engineered HSC (eHSC) platform, with the goal of generating novel treatment systems for patients fighting acute myeloid leukemia (AML) and other devastating forms of blood cancer. − In June 2021, Vor announced the appointment of Matthew R. Patterson as Chairman of its Board of Directors. − In the July 2021 post-period, Vor announced the formation of a collaboration with Janssen Biotech, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The agreement was facilitated by Johnson & Johnson Innovation. Under the terms of the collaboration, Vor will investigate the combination of these two technologies into a treatment solution, pairing Vor’s “invisible” eHSC transplant platform with one of Janssen’s bi-specific antibodies in development for AML. The collaboration agreement provides that each company retains all rights and ownership to their respective programs and platforms. − In the August 2021 post-period, Vor announced it expects to enroll the first patient in a Phase 1/2a clinical trial for VOR33 in AML in the next few months. Vor remains on track to report initial clinical data from this trial in the first half of 2022. Additionally, Vor expects initial VCAR33 monotherapy clinical data in 2022, depending on investigator’s timing of data release. Vor also expects to file an IND for the VOR33/VCAR33 Treatment System in the second half of 2022. 6. Important Safety Information: Patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide should not take Plenity. To avoid impact on the absorption of medications: For all medications that should be taken with food, take them after starting a meal. For all medications that should be taken without food (on an empty stomach), continue taking on an empty stomach or as recommended by your physician. The overall incidence of side effects with Plenity was no different than placebo. The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. Contact a doctor right away if problems occur. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. Rx Only. For the safe and proper use of Plenity or more information, talk to a healthcare professional, read the Patient Instructions for Use, or call 1-844-PLENITY. 7. EndeavorRx is a digital therapeutic 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. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure, Test of Variables of Attention (TOVA®) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. There were no serious adverse events; 9.3% of subjects experienced side effects, including frustration, headache, dizziness, emotional reaction, nausea or aggression. EndeavorRx is only available to your patients through a prescription, and is not intended as a stand-alone therapeutic or a substitute for your patient’s medication. Upcoming Milestones (next 12 to 24 months) Multiple important milestones are anticipated over the next 12 to 24 months: PureTech is planning the trial design that will potentially enable registration of LYT-100-ILD for the treatment of IPF and potentially other PF-ILDs. PureTech expects to provide additional guidance in the fourth quarter of 2021, following discussion with regulatory agencies and which may also be informed by additional ongoing Phase 1 studies of LYT-100. PureTech expects topline results from the Phase 2 trial of LYT-100-COV in adults with Long COVID respiratory complications and related sequelae by the end of 2021. PureTech expects topline results from the Phase 2a proof-of-concept study of LYT-100-LYMPH in patients with breast cancer-related, upper limb secondary lymphedema in 2022. PureTech expects topline results from three additional clinical trials of LYT-100 in the fourth quarter of 2021. These additional studies are designed to explore further the PK, dosing and tolerability in healthy volunteers. One of these trials is an extension of the previously completed MAD study and is designed to determine the maximum tolerated dose of LYT-100 in healthy volunteers. Results from these trials are expected to provide additional supportive data to support clinical development of LYT-100 across indications. PureTech expects results from the Phase 1 portion of a Phase 1/2 clinical trial of LYT-200 in metastatic solid tumors in the fourth quarter of 2021. Pending these results, PureTech intends to initiate the Phase 2 expansion cohort portion of the trial, which is designed to evaluate LYT-200 both alone and in combination with BeiGene’s tislelizumab or chemotherapy for the potential treatment of difficult-to-treat solid tumors. PureTech will continue to explore additional biomarker studies for LYT-210 in 2021. LYT-210 is a preclinical therapeutic candidate targeting immunomodulatory gamma delta-1 T cells that is in development to potentially treat a range of cancer indications. PureTech expects to initiate a clinical trial of LYT-300 by the end of 2021. The initial objective of the clinical program is to characterize the safety, tolerability and PK of orally administered LYT-300 in a Phase 1 clinical trial in healthy volunteers. This study may also explore the impact of LYT-300 on ß-EEG, a marker of GABAA target engagement. Data from this study will be used to define a potential range of future studies and planned indications. PureTech expects preclinical proof-of-concept data for LYT-500 in the first half of 2022. LYT-500 contains a unique combination of IL-22 and an anti-inflammatory drug, which is designed to address the two key underlying causes of IBD pathogenesis and progression, namely mucosal barrier disruption and inflammation. An IND application for LYT-503/IMB-150 is planned to be filed in early 2022. LYT-503/IMB-150 is being advanced in collaboration with Imbrium Therapeutics as a potential non-opioid treatment for IC/BPS. PureTech expects preclinical proof-of-concept data for its Orasome technology platform in 2021. The proof-of-concept study is designed to observe the presence of therapeutic serum levels of biotherapeutics (peptides and proteins, such as antibodies) produced by the body following the oral administration of designer payloads. This work could lay the foundation for IND-enabling clinical studies for one or more additional therapeutic candidates to be included in the Company’s Wholly Owned Pipeline. Gelesis anticipates the full commercial U.S. launch of Plenity in the second half of 2021. Gelesis expects topline results from a Phase 2 study of GS200 in weight management and glycemic control in adults with type 2 diabetes and prediabetes in 2021. Data from a pilot study of GS200 demonstrated that administration of GS200 ten minutes prior to a meal increased fullness throughout the entire day (P=0.012). Gelesis expects topline results of a pilot study of GS300 in NASH/NAFLD in the fourth quarter of 2023. Gelesis expects topline results from a pivotal study of GS500 in functional constipation in the second quarter of 2023. Karuna is on track to initiate the Phase 3 ARISE trial evaluating the safety and efficacy of KarXT compared to placebo as an adjunctive treatment in adults with schizophrenia who have an inadequate response to their current antipsychotic therapy in the second half of 2021. Karuna plans to initiate a Phase 2 trial evaluating KarXT in dementia-related psychosis in the first half of 2022. Karuna anticipates reporting topline data from the Phase 3 EMERGENT-2 trial in mid-2022. Follica plans to initiate a Phase 3 registration program in male androgenetic alopecia in 2022. Vedanta anticipates topline results from the Phase 2 clinical trial of VE303 in patients at high risk of recurrent Clostridioides difficile infection (CDI) in the third quarter of 2021 and to initiate a Phase 3 trial of VE303 in mid-2022. Vedanta expects to complete the build-out of its Phase 3 and commercial launch cGMP manufacturing facility for supply of VE303 by the end of 2021. Vedanta expects to initiate a Phase 2 study of VE202 in patients with mild to moderate ulcerative colitis in the second half of 2021. Vedanta expects topline data from the Phase 1/2 clinical trial of VE416 for food allergy in 2022, subject to investigator timelines. In the third quarter of 2021, Sonde plans to announce the launch of Sonde Mental Fitness. Sonde expects to expand outside of respiratory indications, beginning with mental fitness. Sonde plans to launch key pilot programs in the employer wellness, health system and provider space in 2022. Akili expects a scaled approach to the commercial launch of EndeavorRx in the second half of 2021. Akili is exploring geographic expansion opportunities as part of its global strategy with a near-term focus on launching the EndeavorRx prescription treatment in the U.S. first. Vor expects to enroll the first patient in a Phase 1/2a clinical trial for VOR33 in AML in the next few months. Vor remains on track to report initial clinical data from the VOR33 Phase 1/2a clinical trial in the first half of 2022. Vor expects initial VCAR33 monotherapy clinical data in 2022, depending on investigator’s timing of data release. Vor expects to file an IND for the VOR33/VCAR33 Treatment System in the second half of 2022. Financial Highlights: PureTech Level Cash and Cash Equivalents as of June 30, 2021 were $409.7 million1 (December 31, 2020: $349.4 million) Consolidated Cash and Cash Equivalents as of June 30, 2021 were $439.8 million2 (December 31, 2020: $403.9 million) Founded Entities also strengthened their collective balance sheets by attracting $636.2 million8 as of June 30, 2021 in equity investments and non-dilutive funding, including $634.6 million from third parties. The balance of the funding is between PureTech and its Founded Entities. Since July 2018, Founded Entities have raised over $1,636 million, of which $1,566 million (96%) was from third parties. Operating Loss for the period was $68.1 million (June 30, 2020: 52.8 million). 8. Funding figure includes private equity financings, loans and promissory notes, public offerings, or grant awards. Funding figure excludes future milestone considerations received in conjunction with partnerships and collaborations such as with, Boehringer Ingelheim, Imbrium Therapeutics L.P., Shionogi & Co Ltd, or Eli Lilly About 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. 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. For more information, visit www.puretechhealth.com or connect with us on Twitter @puretechh. Cautionary Note Regarding Forward-Looking Statements This press release contains statements that are or may be forward-looking statements, including statements that relate to the Company's and its Founded Entities’ future prospects, plans, 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, our expectations regarding the potential therapeutic benefits of our product candidates and those of our Founded Entities, our expectations regarding upcoming milestones and timing, including with respect to filings with regulators, clinical trial initiations and expected data readouts, our ability to broaden access to an international investor base, our cash runway and financial position as well as those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc (including the risk factors in our most recently filed Annual Report and Accounts and Form 20-F). These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Interim Management Report Introduction PureTech’s distinctive model for bringing innovative medicines to patients has led to rapid advancement across its Wholly Owned Pipeline and Founded Entities over the first six months of 2021. These programs have achieved a number of clinical and business milestones towards the Company’s mission of developing transformational medicines for millions of people who have long struggled to find effective treatments. PureTech’s productive R&D engine has resulted in 25 therapeutics and therapeutic candidates that are being advanced across its Wholly Owned Pipeline and Founded Entities, including two that have been cleared for marketing both by the U.S. FDA and granted marketing authorization in the EEA. 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 into the biology of the BIG systems and the interface between those systems, which is referred to as the BIG Axis. The PureTech R&D model leverages collaboration with the world’s leading experts around specific diseases, bringing together cross disciplinary perspectives and exploring multiple approaches to tackling that disease. The process to identify, invent and advance scientific breakthroughs also includes de-risking experiments before advancing new programs. This model has enabled PureTech to consistently gain early access to breakthrough discoveries well before the rest of the world reads about them in major scientific journals. PureTech’s R&D focus has centered on the biology of the Brain-Immune-Gut Axis and the crosstalk between those systems is gaining prominence across scientific disciplines. PureTech’s Wholly Owned Pipeline, in which PureTech retains 100 percent ownership, has rapidly advanced during the first six months of 2021, with two Phase 2 and four Phase 1 clinical trials underway and the trial design that will potentially enable registration of LYT-100-ILD for the treatment of IPF and potentially other PF-ILDs being planned. PureTech’s four lymphatic and inflammation platforms, from which three novel therapeutic candidates have already been identified, have also continued to progress, with key preclinical data published in two peer-reviewed journals so far in 2021. PureTech’s eight Founded Entities, which PureTech initiated and co-invented, also achieved key milestones, including Vor’s $203.4 million initial public offering in February 2021, Gelesis’ announcement that it has entered into a definitive business combination agreement with Capstar Special Purpose Acquisition Corp. in the July 2021 post-period, Karuna’s continued progress with its Phase 3 program for KarXT in schizophrenia and Akili’s scaled approach to the U.S. commercialization of EndeavorRx. PureTech holds sizable equity positions across its Founded Entities and continues to benefit from their growth, including from events such as M&A transactions, IPOs and potential royalties from certain product sales. For example, in the first half of 2021, PureTech generated $118 million from the monetization of some of its equity positions in Founded Entities. The combination of the development of the Wholly Owned Programs, advancement of the Founded Entities and optionality to pursue non-dilutive partnerships and funding provides a distinctive and multi-pronged engine to fuel potential future growth while allowing PureTech to more fully capture the value of milestones at a PureTech parent company level. Notable Developments Wholly Owned Programs In the first half of 2021, PureTech has continued to strengthen its Wholly Owned Programs focused on the lymphatic system and related immunological and inflammatory disorders. PureTech has continued to advance its clinical-stage product candidate LYT-100 (deupirfenidone) for the potential treatment of conditions involving inflammation and fibrosis, including lung disease (e.g., IPF and potentially other PF-ILDs and Long COVID respiratory complications and related sequelae), and disorders of lymphatic flow, such as lymphedema. Two Phase 2 clinical trials of LYT-100 progressed in the first half of 2021: 1) A global, randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the efficacy, safety and tolerability of LYT-100-COV in adults with Long COVID respiratory complications and related sequelae. Topline results from this trial are expected by the end of 2021. 2) A Phase 2a proof-of-concept study of LYT-100-LYMPH in patients with breast cancer-related, upper limb secondary lymphedema. Topline results from this trial are expected in 2022. PureTech has also initiated a three-month, open-label extension of the LYT-100-COV Phase 2 trial in adults with Long COVID respiratory complications and related sequelae who completed the first portion of the trial. The primary endpoint of the extension trial is to assess the longer-term safety and tolerability of LYT-100-COV through up to 182 days of treatment. Additionally, PureTech also initiated three additional Phase 1 clinical trials in 2021 to explore further the PK, dosing and tolerability of LYT-100 in healthy volunteers. One of these trials is an extension of the previously completed MAD study and is designed to determine the maximum tolerated dose of LYT-100 in healthy volunteers. Results from these trials are anticipated in the fourth quarter of 2021 and are expected to provide additional data to inform the clinical development of LYT-100 across indications. In April 2021, PureTech announced the formation of its Clinical Advisory Board for IPF and other PF-ILDs. Comprised of physicians and researchers with deep expertise in the clinical development of novel therapies in PF-ILDs, the advisory group will work closely with PureTech as it advances LYT-100-ILD. PureTech is planning the trial design that will potentially enable registration of LYT-100-ILD for the treatment of IPF and potentially other PF-ILDs. PureTech expects to provide additional guidance in the fourth quarter of 2021, following discussion with regulatory agencies and which may also be informed by additional ongoing Phase 1 studies of LYT-100. Additionally, in the August 2021 post-period, PureTech presented the results of the Phase 1 multiple ascending dose and food effect study of LYT-100 at the virtual European Respiratory Society International Congress. LYT-200 is currently being evaluated as a single agent in the Phase 1 portion of a Phase 1/2 clinical trial. The primary objective of the Phase 1 portion of the trial is to assess the safety and tolerability of escalating doses of LYT-200 to identify a dose to carry forward into the Phase 2 portion of the trial. The Phase 1 portion will also assess the PK and PD profiles of LYT-200. Results from the Phase 1 portion of the study are anticipated in the fourth quarter of 2021. Pending these results, PureTech intends to initiate the Phase 2 expansion cohort portion of the trial, which is designed to evaluate LYT-200 both alone and in combination with chemotherapy or BeiGene’s tislelizumab, an anti-PD-1 mAb for which PureTech and an affiliate of BeiGene, Ltd. entered into a clinical trial and supply agreement in the July 2021 post-period. Under the terms of the agreement, PureTech will maintain control of the LYT-200 program, including global R&D and commercial rights, and BeiGene has agreed to supply tislelizumab for use in combination with LYT-200 for the planned study. PureTech will also continue to explore additional biomarker studies for LYT-210 in 2021. In the first half of 2021, PureTech also progressed LYT-300, its most advanced candidate derived from the Glyph technology platform, towards the clinic. LYT-300 is an oral form of natural allopregnanolone which PureTech believes may be applicable for the potential treatment of a range of neurological and neuropsychological conditions. PureTech expects to initiate a clinical trial of LYT-300 by the end of 2021. The initial objective of the clinical program is to characterize the safety, tolerability and PK of orally administered LYT-300 in a Phase 1 clinical trial in healthy volunteers. Data from this study will be used to define a potential range of future studies and planned indications. PureTech also continued to advance the underlying Glyph technology platform, which is designed to employ the body’s natural lipid absorption and transport process to orally administer drugs via the lymphatic system. In February 2021, a preclinical proof-of-concept study for the Glyph technology was published in the Journal of Controlled Release. Results demonstrated the ability of this platform to directly target gut lymphatics with an orally dosed small molecule immunomodulator. In June 2021, PureTech announced the acquisition of the remaining 22 percent of shares outstanding in its Founded Entity, Alivio. The underlying Alivio technology platform, which is designed to enable inflammation-targeted immunomodulation for the potential treatment of a range of chronic and acute inflammatory disorders, and related undisclosed anti-inflammatory candidates have also been added to PureTech’s discovery programs. Alivio’s therapeutic candidates, in development for inflammatory disorders including IBD, have also been integrated into PureTech’s Wholly Owned Pipeline. The first of these candidates is LYT-500, an orally-administered therapeutic candidate in development for the treatment of IBD that contains a unique combination of IL-22 and an anti-inflammatory drug and is designed to address the two key underlying causes of IBD pathogenesis and progression, namely mucosal barrier disruption and inflammation. PureTech expects preclinical proof-of-concept data for LYT-500 in the first half of 2022. In addition, LYT-503/IMB-150 is a therapeutic candidate being advanced in collaboration with Imbrium Therapeutics for the potential treatment of IC/BPS, a chronic inflammatory condition of the bladder that lacks an effective treatment option. The LYT-503/IMB-150 therapeutic candidate is designed to selectively treat inflamed tissues along the bladder wall, while minimizing the potential for drug- related side effects in healthy parts of the body. In the August 2021 post-period, PureTech announced that Imbrium exercised a license option under the companies’ research and development collaboration agreement to develop PureTech’s LYT-503/IMB-150. In connection with the option exercise, PureTech received an upfront payment of $6.5 million and is eligible to receive up to $53 million in additional development milestone payments for this program as well as royalties on product sales. Imbrium plans to file an IND application for LYT-503/IMB-150 in early 2022. PureTech also progressed its Orasome technology platform, which utilizes a programmable and scalable approach for the oral administration of nucleic acids and other biologics. PureTech expects preclinical proof-of-concept data in 2021. The proof-of-concept study is designed to observe the presence of therapeutic serum levels of biotherapeutics (peptides and proteins, such as antibodies) produced by the body following the oral administration of designer payloads. This work could lay the foundation for IND-enabling clinical studies for one or more additional therapeutic candidates to be included in the Company’s Wholly Owned Pipeline. PureTech intends to leverage its proprietary technology platforms, as well as its extensive network with major pharmaceutical companies and world-leading scientists in immunology and lymphatics, to generate additional novel therapeutic candidates. PureTech continued to advance its meningeal lymphatics research program, which harnesses the meningeal lymphatics to potentially treat a range of neurodegenerative and neuroinflammatory conditions. In April 2021, PureTech announced the publication of preclinical research in Nature, suggesting that restoring lymphatic flow in the brain has the potential to address a range of neurodegenerative diseases, such as Alzheimer's and Parkinson's diseases, and associated neuroinflammation. The work also uncovered a link between dysfunctional meningeal lymphatics and damaging microglia activation in Alzheimer's disease, suggesting another route by which restoring healthy drainage patterns could improve clinical outcomes. In the August 2021 post-period, PureTech announced the appointment of Julie Krop, M.D., as Chief Medical Officer. Dr. Krop will oversee all clinical development, regulatory, CMC and medical affairs for the Company’s advancing Wholly Owned Pipeline. Dr. Krop joins PureTech from Freeline Therapeutics, a clinical-stage gene therapy company, where she served as Chief Medical Officer. Prior to this role, Dr. Krop served as Chief Medical Officer of AMAG Pharmaceuticals (acquired by Covis group for $647 million), where she oversaw clinical development, regulatory affairs, clinical operations, medical affairs, program management and pharmacovigilance. During her time at AMAG, Dr. Krop was responsible for the oversight of three FDA approvals. Earlier in her career, she held leadership positions at Vertex Pharmaceuticals, Stryker Regenerative Medicine, Peptimmune, Millennium Pharmaceuticals and Pfizer. Dr. Krop received her M.D. from Brown University School of Medicine and completed an internal medicine residency at Georgetown University Hospital. Additionally, she completed fellowships in epidemiology, clinical trial design and endocrinology as a Robert Wood Johnson Foundation Clinical Scholar at the Johns Hopkins School of Medicine. Commenting on her appointment, Dr. Krop said: “I am thrilled to join the leadership team at PureTech during such an exciting time in the Company’s growth and clinical development. PureTech’s research and development model is a truly unique approach that has fostered a broad wealth of expertise within the Company that now powers the team’s innovative development efforts across multiple therapeutic candidates. I look forward to helping drive PureTech’s mission and advancing an incredibly promising pipeline of investigational therapies for patients in need.” Founded Entities PureTech’s Founded Entities have had a productive 2021 so far with significant clinical progress and a number of strategic financings. Founded Entities in which PureTech has a controlling interest or the right to receive royalties, in order of development stage Gelesis has continued to advance its novel category of treatments for weight management and gut related chronic diseases. Gelesis made progress towards the full commercial U.S. launch of Plenity in the second half of 2021 and plans to seek FDA input on the requirements for potentially expanding the Plenity label for treating adolescents. In the July 2021 post-period, Gelesis and Capstar Special Purpose Acquisition Corp. (NYSE: CPSR) (Capstar) and certain private funds managed by PIMCO announced that they have entered into a definitive business combination agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on the NYSE under the symbol “GLS.” The transaction is expected to close in the fourth quarter of 2021, subject to satisfying certain closing conditions. With input from a scientific advisory board of scientific leaders in NASH research, Gelesis developed a research protocol for a pilot study of GS300. Gelesis expects to enroll approximately 250 subjects in the study with topline results anticipated in the fourth quarter of 2023. Gelesis also expects topline results from a pivotal study of GS500, the company’s therapeutic candidate designed to treat functional constipation, in the second quarter of 2023. Additionally, Gelesis expects topline results from a Phase 2 study of GS200, Gelesis’ candidate for weight management and glycemic control in adults with type 2 diabetes and prediabetes, in 2021. Data from a pilot study of GS200 demonstrated that administration of GS200 ten minutes prior to a meal increased fullness throughout the entire day (P=0.012). Additionally, in May 2021, Gelesis presented a scientific poster at the AACE 2021 Annual Virtual Meeting. The post-hoc analysis showed that treatment for weight management with Plenity decreased a marker for liver fibrosis (the NAFLD fibrosis score) compared to placebo. This retrospective analysis of Gelesis' GLOW (Gelesis Loss of Weight) pivotal study assessed the impact of oral superabsorbent hydrogel (OSH) treatment on liver health as measured by the NFS, which is intended to predict the presence of significant fibrosis using common clinical and laboratory values, including age, BMI, diabetes status, AST/ALT ratio, platelet count and serum albumin. The data support the rationale for conducting further trials to evaluate OSH for the treatment of metabolic-related liver diseases. In April 2021, Gelesis announced the appointment of marketing executive Jane Wildman to its Board of Directors. Ms. Wildman has extensive experience as a board member, President and Chief Marketing Officer across Fortune-25, mid-sized and start-up companies, including having spent over 25 years at Procter & Gamble. Karuna made progress towards developing its novel therapies with the potential to transform the lives of people with psychiatric and neurological conditions, including schizophrenia and dementia-related psychosis. In the August 2021 post-period, Karuna announced that all Phase 3 trials in the EMERGENT clinical program evaluating KarXT for the treatment of psychosis in adults with schizophrenia are enrolling. Karuna anticipates reporting topline data from the Phase 3 EMERGENT-2 trial in mid-2022. Also in the August 2021 post-period, Karuna announced that it is on track to initiate the Phase 3 ARISE trial evaluating the safety and efficacy of KarXT compared to placebo as an adjunctive treatment in adults with schizophrenia who have an inadequate response to their current antipsychotic therapy in the second half of 2021. The Phase 3, six-week, 1:1 randomized, double-blind, placebo-controlled trial will enroll approximately 400 adults with schizophrenia who have not achieved an adequate response to current atypical antipsychotic treatment. Participants in this trial will continue their currently prescribed atypical antipsychotic therapy at the same dose or regimen schedule as prior to entry in the study, and will receive a flexible dose of KarXT or placebo based on tolerability and clinical response as determined by a clinician. The primary outcome measure of the trial is change in Positive and Negative Syndrome Scale (PANSS) total score of KarXT compared to placebo at Week 6. Upon completion of the trial at week 6, participants will have the opportunity to enroll in a 52-week outpatient, open-label extension trial evaluating the long-term safety and tolerability of KarXT when dosed with antipsychotic treatment. In June 2021, Karuna announced data from its completed Phase 1b trial evaluating the safety and tolerability of KarXT in healthy elderly volunteers, which followed a preliminary analysis of data from the first two cohorts in the trial announced earlier this year. The results suggest that KarXT can be administered to elderly volunteers at doses which achieve xanomeline blood levels similar to those reported in the Phase 2 EMERGENT-1 trial in adults with schizophrenia while maintaining a favorable tolerability profile. Data from the trial also suggest that a lower dose ratio of trospium to xanomeline, compared to the ratios used in Phase 1 trials in healthy adult volunteers and in the Phase 2 EMERGENT-1 trial evaluating KarXT in adults with schizophrenia, was better tolerated by healthy elderly volunteers. Based on results from the Phase 1b trial in healthy elderly volunteers, Karuna plans to initiate a Phase 2 trial evaluating KarXT in dementia-related psychosis in the first half of 2022. In February 2021, Karuna announced that results from the EMERGENT-1 Phase 2 clinical trial evaluating KarXT for the treatment of schizophrenia were published in NEJM. In March 2021, Karuna completed a follow-on public offering of its common stock, from which it received gross proceeds of $269.8 million, before deducting the underwriting discounts and commissions and other estimated offering expenses. Also in February 2021, PureTech sold one million shares of Karuna common stock for cash consideration of approximately $118 million. PureTech intends to use the proceeds from the transaction to further expand and advance its clinical-stage Wholly Owned Pipeline. Follica continued to advance its regenerative biology platform designed to treat androgenetic alopecia, epithelial aging and other medical indications. In January 2021, Follica announced the appointment of two leaders in aesthetic medicine and dermatology to its Board of Directors. Tom Wiggans, former CEO of Dermira, joined as Executive Chairman with over 30 years of experience leading biopharmaceutical companies from the start-up stage to global commercialization, and Michael Davin, former CEO of Cynosure, joined as an Independent Director with over 30 years of experience in the medical device industry. Preparations are underway for the Phase 3 registration program in male androgenetic alopecia and initiation is anticipated in 2022. The company also has proprietary amplification compounds in development and ongoing discovery efforts to expand its pipeline. Vedanta

Predict your next investment

The CB Insights tech market intelligence platform analyzes millions of data points on venture capital, startups, patents , partnerships and news mentions to help you see tomorrow's opportunities, today.

CB Insights uses Cookies

CBI websites generally use certain cookies to enable better interactions with our sites and services. Use of these cookies, which may be stored on your device, permits us to improve and customize your experience. You can read more about your cookie choices at our privacy policy here. By continuing to use this site you are consenting to these choices.