KRTX Karuna Therapeutics Inc.

114.22
+0.81  (+1%)
Previous Close 113.41
Open 113.41
52 Week Low 69.58
52 Week High 146.97
Market Cap $3,364,680,881
Shares 29,457,896
Float 22,654,992
Enterprise Value $2,772,004,985
Volume 130,363
Av. Daily Volume 184,782
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Drug Pipeline

Drug Stage Notes
KarXT
Healthy elderly volunteers / dementia-related psychosis
Phase 1b
Phase 1b
Phase 2 trial to commence 1H 2022.
KarXT
Acute psychosis in patients with schizophrenia
Phase 3
Phase 3
Phase 3 EMERGENT-2 and EMERGENT-4 trials initiated December 2020 and 1Q 2021
KarXT
Pain in healthy volunteers
Phase 1b
Phase 1b
Phase 1b data released August 3, 2020. Insufficient evidence of an analgesic benefit compared to placebo. Development to be discontinued for pain indication.

Latest News

  1. Public listing of Gelesis, along with Karuna Therapeutics (NASDAQ:KRTX) and Vor Biopharma (NASDAQ:VOR), five other private Founded Entities and advanced Wholly Owned Pipeline, further exemplifies the success of PureTech's unique value-generating model for developing new medicines

    At Closing, Gelesis is expected to have a pro forma implied market value of approximately $1.3 billion to support full commercial launch of Plenity® for weight management and further expand manufacturing capacity to meet demand

    Transaction is expected to provide Gelesis with up to $376 million of gross proceeds, including $100 million PIPE anchored by new and existing top tier investors and partners

    PureTech Health plc (NASDAQ:PRTC, LSE: PRTC))) ("PureTech" or the…

    Public listing of Gelesis, along with Karuna Therapeutics (NASDAQ:KRTX) and Vor Biopharma (NASDAQ:VOR), five other private Founded Entities and advanced Wholly Owned Pipeline, further exemplifies the success of PureTech's unique value-generating model for developing new medicines

    At Closing, Gelesis is expected to have a pro forma implied market value of approximately $1.3 billion to support full commercial launch of Plenity® for weight management and further expand manufacturing capacity to meet demand

    Transaction is expected to provide Gelesis with up to $376 million of gross proceeds, including $100 million PIPE anchored by new and existing top tier investors and partners

    PureTech Health plc (NASDAQ:PRTC, LSE: PRTC))) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company announces that its Founded Entity, Gelesis, Inc. ("Gelesis") and Capstar Special Purpose Acquisition Corp. (NYSE:CPSR) ("Capstar"), 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."

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210719005358/en/

    PureTech's Founded Entity Gelesis, the maker of Plenity, is to become a publicly traded company via a merger with Capstar. Gelesis, along with PureTech's other Founded Entities Karuna (KRTX) and Vor (VOR) developed from the Company's R&D engine, will have a combined market value of over $5.4B, further exemplifying the success of PureTech's unique value-generating business model for developing new medicines.

    PureTech's Founded Entity Gelesis, the maker of Plenity, is to become a publicly traded company via a merger with Capstar. Gelesis, along with PureTech's other Founded Entities Karuna (KRTX) and Vor (VOR) developed from the Company's R&D engine, will have a combined market value of over $5.4B, further exemplifying the success of PureTech's unique value-generating business model for developing new medicines.

    "Upon completion of the transaction, Gelesis will be PureTech's third publicly-traded Founded Entity. Based on the expected valuation, Gelesis, along with Karuna and Vor, will have a combined value of over $5.4 billion," said Eric Elenko, Chief Innovation Officer at PureTech. "This is just another example of the unique and multi-pronged model PureTech has created to advance meaningful treatments for patients and drive future growth. We are very pleased with the progress that has been made towards the broad commercial launch of Plenity later this year and that Gelesis has the resources to meet the increasing demand."

    Gelesis and Capstar will host a joint investor conference call to discuss the transaction today, July 19, 2021, at 8:30 a.m. Eastern Time. A telephone replay of the call will be available until July 29, 2021 via the same numbers, and a replay of the webcast will be archived on the investor relations website.

    The conference call can be accessed via webcast on Gelesis' investor relations website at gelesis.com/investors, or by dialing +1 844-512-2921 within the U.S. or +1 412-317-6671 for international callers and entering the passcode 1145464.

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

    Gelesis, a Consumer-Focused Biotherapeutics Company and the Maker of Plenity®, to Become a Publicly Traded Company via Merger with Capstar Special Purpose Acquisition Corp.

    • Building on the successful beta launch of its first product Plenity®, Gelesis aims to transform weight management. Gelesis developed a novel biomimetic therapeutic platform that has yielded Plenity and an advanced pipeline of therapeutic candidates for a range of other gut-related disorders
    • Plenity makes it easier to eat less and feel fuller with smaller portions and offers a new weight management solution for over 150 million Americans, many of whom did not have a prescription alternative before. Plenity is FDA-cleared to aid in weight management in adults with excess weight or obesity, Body Mass Index (BMI) of 25 to 40 kg/m², when used in conjunction with diet and exercise
    • Pro forma implied market value of approximately $1.3 billion and enterprise value of approximately $1.0 billion
    • Transaction is expected to provide Gelesis with up to $376 million of gross proceeds to fund the full commercial launch of Plenity later this year and to expand manufacturing to meet demand, including $100 million from a common stock PIPE financing at $10.00 per share anchored by new and existing top tier investors and partners, including PIMCO private funds, Kennedy Lewis Investment Management, Pritzker Vlock Family Office, China Medical Systems Holdings Limited (CMS), and co-founder PureTech Health

    BOSTON, MA & AUSTIN, TX, JULY 19, 2021 – Gelesis, Inc. ("Gelesis" or the "Company"), a biotherapeutics company advancing biomimetic superabsorbent hydrogels to treat excess weight and metabolic disorders, 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 today 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."

    A New Approach to Weight Management

    Gelesis is a biotherapeutics company aiming to transform weight management using a proprietary biomimetic superabsorbent hydrogel technology. The Company's first commercial product, Plenity®, is a U.S. Food and Drug Administration (FDA) cleared aid in weight management in adults with excess weight or obesity, Body Mass Index (BMI) of 25 to 40 kg/m², when used in conjunction with diet and exercise. Plenity has the broadest BMI range of any prescription weight-management aid to date—over 150 million American adults could be eligible for treatment with Plenity, many of whom did not have a prescription alternative before. Plenity's unique scientific approach and efficacy, safety and tolerability profile allow Gelesis to bring it to market in a completely new way.

    Plenity capsules contain a non-systemic biomimetic hydrogel that is not absorbed but instead acts locally in the gastrointestinal (GI) tract. The capsules are taken with water before meals and are designed to help people feel satisfied with smaller meals. Plenity combines the simplicity and convenience of a consumer product with clinical and scientific validation as well as FDA regulatory clearance as a de novo Class II medical device. In clinical studies, ~6 out of 10 adults had clinically meaningful weight loss and those people lost on average, within six months, ten percent of their body weight (about 22 lbs). There was no difference in overall side effects compared to placebo. The most common side effects were diarrhea, distended abdomen, infrequent bowel movements and flatulence.

    Plenity is a prescription product with a direct-to-patient approach, giving the consumer the option of going through leading telehealth platform Ro, or through an in-person healthcare provider visit. This makes it easier for consumers to seek free physician evaluation on their own time and their own terms. If prescribed, the product is delivered to the consumer's home within two days at a transparent cost of $98/month, or $1.75 per meal.

    Plenity is now available in limited release, and over 48,000 members have begun their weight management journey. During Plenity's beta launch in October 2020, with limited promotion and without brand awareness marketing, Plenity surpassed all branded prescription weight management products in new monthly members during the month of testing, with high satisfaction ratings. The Company anticipates the full commercial launch of Plenity later in 2021 and is currently constructing a larger manufacturing facility to meet anticipated demand.

    Gelesis' novel platform technology is inspired by the structural and mechanical properties of raw vegetables. When consumed, the hydrogel forms small solid gel pieces in the stomach consisting of water held by a 3D cellulose structures, similar to raw vegetables. The structures, which have no calories, are homogeneously mixed with the ingested foods, increasing the volume and firmness of that meal while reducing its caloric density. The hydrogel pieces are not absorbed and partially degrade in the large intestine, releasing the water before leaving the body naturally. In clinical trials, this therapeutic approach demonstrated a strong efficacy and safety profile.

    Management Comments

    "We are delighted to have found such a stellar group of partners and investors as we expand the launch of the first and only FDA-cleared and clinically validated prescription aid for weight management that is available for the broadest range of the population with excess weight, including even those who are overweight without co-morbidities," said Yishai Zohar, Founder and CEO of Gelesis. "Capstar's leadership team has a track record of successfully building known brands and tackling fundamental consumer problems across a variety of industries. We look forward to building on the exciting momentum of our beta launch with this partnership and funding, and we are committed to making a meaningful difference in the lives of millions of Americans seeking scientifically proven and convenient options to manage their weight."

    "Yishai and the Gelesis team have developed a tremendous solution that is poised to transform the weight management industry," said Steve Hicks, the Chairman and CEO of Capstar. "We raised our Capstar SPAC last year with the goal of finding a high-growth, disruptive business that is helping people live a better, healthier life. Gelesis fits that criteria perfectly and we are elated to partner with them as they start their exciting next leg of growth."

    Transaction Overview

    The transaction values the combined company at an implied enterprise value of approximately $1.0 billion and equity value of approximately $1.3 billion, based on a $10.00 per share price of Capstar common stock and assuming no redemptions by Capstar's public shareholders. The transaction will provide up to $376 million in gross proceeds to the combined company from a combination of a $100 million common stock PIPE financing at $10.00 per share along with $276 million of cash held in Capstar's trust account (assuming no redemptions by Capstar's public shareholders). The PIPE financing is anchored by a mix of new and existing top tier investors and partners, including PIMCO private funds, Pritzker Vlock Family Office, China Medical Systems Holdings Limited (CMS), and co-founder PureTech Health. Kennedy Lewis Investment Management will invest $10 million in the PIPE conditioned upon the closing of their $100 million senior secured credit facility to the Company, which is subject to the completion of due diligence, final documentation, and customary closing conditions. Proceeds from the business combination, PIPE, and credit facility will be primarily used to support the full commercial launch of Plenity for weight management later this year and expanded manufacturing to meet consumer demand. Gelesis' existing shareholders will convert 100% of their ownership stakes into the new company.

    The transaction has been unanimously approved by the Boards of Directors of both Gelesis and Capstar. It is expected to close in the fourth quarter of 2021, subject to the satisfaction of certain closing conditions, including a registration statement being declared effective by the U.S. Securities and Exchange Commission (the "SEC") and the approval of Capstar shareholders.

    Additional information about the transaction, including a copy of the business combination agreement and investor presentation, will be provided in a Current Report on Form 8-K to be filed by Capstar with the SEC and available at www.sec.gov.

    Advisors

    Citi is serving as exclusive financial advisor to Gelesis and Goodwin Procter LLP is serving as legal counsel to Gelesis. UBS Investment Bank is serving as exclusive financial and lead capital markets advisor to Capstar and Kramer Levin Naftalis & Frankel LLP is serving as its legal counsel. UBS Investment Bank and Citi are serving as private placement agents to Capstar with respect to the PIPE financing. Winston & Strawn LLP served as counsel to the placement agents. BTIG, LLC is also serving as a capital markets advisor to Capstar.

    Conference Call Information

    Gelesis and Capstar will host a joint investor conference call to discuss the transaction today, July 19, 2021, at 8:30 a.m. Eastern Time. A telephone replay of the call will be available until July 29, 2021 via the same numbers, and a replay of the webcast will be archived on the investor relations website.

    The conference call can be accessed via webcast on Gelesis' investor relations website at gelesis.com/investors, or by dialing +1 844-512-2921 within the U.S. or +1 412-317-6671 for international callers and entering the passcode 1145464.

    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.

    About Gelesis

    Gelesis is a consumer-centered biotherapeutics company advancing a novel category of treatments for weight management and gut related chronic diseases. Our non-systemic superabsorbent hydrogels are inspired by the composition (i.e., water & cellulose) and mechanical properties (e.g., elasticity or firmness) of raw vegetables. They are conveniently administered in capsules to create a much larger volume of small, non-aggregating hydrogel pieces that become an integrated part of the meals, and act locally in the digestive system. Our portfolio includes Plenity®, an FDA-cleared product to aid in weight management, as well as potential therapies in development for Type 2 Diabetes, Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH), and Functional Constipation. For more information, visit gelesis.com, or connect with us on Twitter @GelesisInc.

    About Capstar Acquisition Corp.

    Capstar Special Purpose Acquisition Corp. (NYSE:CPSR) is sponsored by Capstar Sponsor Group, LLC, and is led by Chairman and CEO, R. Steven Hicks. Capstar is a special purpose acquisition company formed for the purpose of effecting a business combination with one or more businesses in the consumer, healthcare and technology, media and telecom industry (TMT) sectors.

    Additional Information and Where to Find It

    Capstar intends to file a Registration Statement on Form S-4 with the SEC, which will include a proxy statement/prospectus, that will be both the proxy statement to be distributed to Capstar shareholders in connection with its solicitation of proxies for the vote by Capstar shareholders with respect to the proposed business combination and other matters as may be described in the Registration Statement, as well as the prospectus relating to the issuance of certain securities to be issued in the proposed business combination. After the Registration Statement is declared effective, the proxy statement/prospectus and other relevant documents will be sent to Capstar and Gelesis shareholders. Capstar also will file other documents regarding the proposed transaction with the SEC. This press release does not contain all the information that should be considered concerning the proposed business combination and is not intended to form the basis of any investment decision or any other decision in respect of the proposed business combination. Before making any voting decision, Capstar's shareholders and other interested persons are advised to read, when available, the preliminary proxy statement/prospectus included in the Registration Statement, the amendments thereto and the definitive proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC in connection with the proposed transaction as they become available because they will contain important information about Gelesis, Capstar and the proposed transaction.

    When available, the definitive proxy statement/prospectus and other relevant materials for the proposed business combination will be mailed to shareholders of Capstar as of a record date to be established for voting on the proposed business combination. Investors and security holders will also be able to obtain free copies of the Registration Statement, the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by Capstar, without charge, once available, through the website maintained by the SEC at www.sec.gov.

    The documents filed by Capstar with the SEC also may be obtained free of charge at Capstar's website at www.capstarspac.com, or by written request to: Capstar Special Purpose Acquisition Corp., 405 West 14th Street, Austin, TX 78701, Attention: R. Steven Hicks, Chief Executive Officer, (512) 340-7800.

    Participants in the Solicitation

    Capstar and its directors and executive officers may be deemed participants in the solicitation of proxies from Capstar's shareholders with respect to the proposed business combination. The names of those directors and executive officers and a description of their interests in Capstar is contained in Capstar's final prospectus dated July 6, 2020 relating to its initial public offering and in subsequent filings with the SEC, which are available free of charge at the SEC's web site at www.sec.gov. To the extent such holdings of Capstar's securities may have changed since that time, such changes have been or will be reflected on Statements of Changes in Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the interests of such participants will be contained in the proxy statement/prospectus for the proposed business combination when available.

    Gelesis and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the shareholders of Capstar in connection with the proposed business combination. A list of the names of such directors and executive officers and information regarding their interests in the proposed business combination will be included in the proxy statement/prospectus for the proposed business combination when available.

    Forward-Looking Statements

    Certain statements, estimates, targets and projections in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws. The words "anticipate," "believe," continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "strive," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements regarding the satisfaction of closing conditions to the proposed business combination and the expected timing of the completion of the proposed business combination, the benefits of the proposed business combination, the competitive environment in which Gelesis operates, the expected future operating and financial performance and market opportunities of Gelesis and statements regarding Gelesis' and Capstar's expectations, hopes, beliefs, intentions or strategies regarding the future,. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Gelesis and Capstar assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Gelesis and Capstar give no assurance that any expectations set forth in this press release will be achieved. Various factors could cause actual future results, performance or events to differ materially from those described herein. Some of the factors that may impact future results and performance may include, without limitation: (i) the size, demand and growth potential of the markets for Plenity®, Gelesis' other product candidates and its ability to serve those markets; (ii) the degree of market acceptance and adoption of Gelesis' products; (iii) Gelesis' ability to develop innovative products and compete with other companies engaged in the weight loss industry; (iv) Gelesis' ability to complete successfully the full commercial launch of Plenity® and its growth plans, including new possible indications and the clinical data from ongoing and future studies about liver and other diseases; (v) the inability of the parties to successfully or timely consummate the proposed business combination, including the risk that any required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the business combination or that the approval of the shareholders of Capstar is not obtained; (vi) the inability of Gelesis to obtain the secured financing from Kennedy Lewis Investment Management; (vii) failure to realize the anticipated benefits of the business combination, including as a result of a delay or difficulty in integrating the businesses of Capstar and Gelesis; (viii) the amount of redemption requests made by Capstar shareholders; (ix) the ability of Capstar or the combined company to issue equity or equity-linked securities or obtain debt financing in connection with the proposed business combination or in the future; (x) the outcome of any legal proceedings that may be instituted against Capstar, Gelesis, the combined company or others following the announcement of the proposed business combination and any definitive agreements with respect thereto; (xi) the ability to meet stock exchange listing standards at or following the consummation of the proposed business combination; (xii) the risk that the proposed business combination disrupts current plans and operations of Gelesis as a result of the announcement and consummation of the proposed business combination, and as a result of the post-transaction company being a publicly listed issuer; (xiii) the regulatory pathway for Gelesis' products and responses from regulators, including the FDA and similar regulators outside of the United States, (xiv) the ability of the combined company to grow and manage growth profitably, maintain relationships with customers and suppliers and retain Gelesis' management and key employees; (xv) costs related to the proposed business combination, including costs associated with the post-transaction company being a publicly listed issuer; (xiv) changes in applicable laws or regulations; (xvi) the possibility that Gelesis or the combined company may be adversely affected by other economic, business, regulatory and/or competitive factors; (xvii) Gelesis' estimates of expenses and profitability; (xviii) ongoing regulatory requirements, (xix) any competing products or technologies that may emerge, (xx) the volatility of the telehealth market in general, or insufficient patient demand; (xxi) the ability of Gelesis to defend its intellectual property and satisfy regulatory requirements; (xxii) the impact of the COVID 19 pandemic on Gelesis' business; (xxiii) the limited operating history of Gelesis; and (xxiv) those factors discussed in Capstar's final prospectus dated July 6, 2020 and Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and the Registration Statement, in each case, under the heading "Risk Factors" and other documents of Capstar filed, or to be filed, with the SEC, including the proxy statement/prospectus on Form S-4 relating to the proposed business combination, which is expected to be filed by Capstar with the SEC. These filings address other important risks and uncertainties that could cause actual results and events to differ materially from those contained in the forward-looking statements.

    Non-Solicitation

    This press release relates to a proposed transaction between Gelesis and Capstar. This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of Capstar, the Company or the combined company, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

    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 26 therapeutics and therapeutic candidates, including two that have received FDA clearance and European marketing authorization, as of the date of PureTech's most recently filed Annual Report on Form 20-F. 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.

    Ownership Information

    PureTech's percentage ownership of Gelesis as at June 30, 2021 was approximately 19.2 percent on a diluted basis, prior to the transaction. This calculation of PureTech's holding includes issued and outstanding shares as well as options and warrants to purchase shares, but excludes unallocated shares authorized to be issued pursuant to equity incentive plans. PureTech's ownership of Gelesis will be updated following completion of the transaction. PureTech has a right to royalty payments as a percentage of net sales from Gelesis.

    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 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, expectations regarding Gelesis' merger with Capstar Special Purpose Acquisition Corp., including expectations regarding the completion of the transaction, expectations regarding the commercial launch of Plenity®, and those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

    This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

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  2. Karuna to initiate a Phase 2 trial evaluating KarXT in dementia-related psychosis in the first half of 2022

    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

    The majority of healthy elderly volunteers in the Phase 1b trial were titrated to xanomeline doses of 150 to 200 mg when dosed with KarXT

    Safety and tolerability profile in Phase 1b trial in healthy elderly volunteers consistent with prior trials of KarXT

    PureTech Health plc (NASDAQ:PRTC, LSE: PRTC))) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated…

    Karuna to initiate a Phase 2 trial evaluating KarXT in dementia-related psychosis in the first half of 2022

    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

    The majority of healthy elderly volunteers in the Phase 1b trial were titrated to xanomeline doses of 150 to 200 mg when dosed with KarXT

    Safety and tolerability profile in Phase 1b trial in healthy elderly volunteers consistent with prior trials of KarXT

    PureTech Health plc (NASDAQ:PRTC, LSE: PRTC))) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, is pleased to note that its Founded Entity, Karuna, today announced data from its completed Phase 1b trial evaluating the safety and tolerability of KarXT (xanomeline-trospium) in healthy elderly volunteers. Karuna had previously announced a preliminary analysis of data from the first two cohorts in the trial earlier this year. 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.

    As of April 30, 2021, PureTech's percentage ownership of Karuna was approximately 8.2 percent on an outstanding voting share basis. PureTech Health has a right to royalty payments as a percentage of net sales from Karuna.

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

    Karuna Therapeutics Announces Results from Phase 1b Trial Evaluating the Safety and Tolerability of KarXT in Healthy Elderly Volunteers

    Company to initiate a Phase 2 trial evaluating KarXT in dementia-related psychosis in the first half of 2022

    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

    The majority of healthy elderly volunteers in the Phase 1b trial were titrated to xanomeline doses of 150 to 200 mg when dosed with KarXT

    Safety and tolerability profile in Phase 1b trial in healthy elderly volunteers consistent with prior trials of KarXT

    BOSTON--(BUSINESS WIRE)--Jun. 23, 2021-- Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced data from its completed Phase 1b trial evaluating the safety and tolerability of KarXT (xanomeline-trospium) in healthy elderly volunteers. The Company had previously announced a preliminary analysis of data from the first two cohorts in the trial earlier this year. Based on results from the Phase 1b trial in healthy elderly volunteers, the Company plans to initiate a Phase 2 trial evaluating KarXT in dementia-related psychosis in the first half of 2022.

    The placebo-controlled, inpatient Phase 1b dose-ranging trial consisted of three cohorts, each enrolling 16 healthy elderly volunteers, randomized 3:1 to receive KarXT or placebo. As part of the flexible dosing protocol, a volunteer's dose was increased if they were tolerating KarXT well at the time of the potential dose increase, as determined by a clinician. In the trial, the majority of healthy elderly volunteers were titrated to xanomeline doses of 150 to 200 mg when dosed with KarXT three times per day. As previously reported, pharmacokinetic data from Cohorts 1 and 2 demonstrated that healthy elderly volunteers achieved mean xanomeline blood levels comparable to, or slightly higher than, the mean xanomeline blood levels reported in the Phase 2 EMERGENT-1 trial evaluating KarXT in adults with schizophrenia. The Company plans to evaluate pharmacokinetic data from Cohort 3, once available. Previous trials of KarXT have demonstrated that the current formulation of KarXT results in xanomeline exposures, or blood levels, that are approximately 10% greater than blood levels seen in earlier trials of xanomeline alone.

    The treatment-related adverse events (AEs) were similar to those observed in prior trials of KarXT, and a majority (>80%) were rated mild in severity. One serious AE of urinary retention was reported in Cohort 1. The Company believes the report of urinary retention was related to a higher dose of trospium used in Cohort 1 compared to doses used in Cohorts 2 and 3, where urinary retention was not observed. No serious or severe AEs were observed in Cohorts 2 and 3. Consistent with prior trials of KarXT, blood pressure in healthy elderly volunteers receiving KarXT was similar to placebo, and no syncopal events were observed. Heart rate increases observed in the trial were also consistent with prior trials of KarXT. Data from the Phase 1b trial 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.

    "We are encouraged that the data from our Phase 1b healthy elderly volunteers trial suggest that potentially therapeutic doses of KarXT can be administered to elderly adults while maintaining a favorable tolerability profile," said Stephen Brannan, M.D., chief medical officer of Karuna Therapeutics. "Results from the third cohort provide additional data as we finalize the dosing and titration protocol for our Phase 2 trial in dementia-related psychosis."

    "The results from the Phase 1b trial in healthy elderly volunteers, as well as a prior Phase 2 study demonstrating the potential of xanomeline to treat and prevent psychosis in patients with Alzheimer's disease, give us confidence in the potential utility of KarXT for the treatment of dementia-related psychosis," added Steve Paul, M.D., chief executive officer, president and chairman of the board of Karuna Therapeutics. "These results support the progression of KarXT into a Phase 2 clinical trial for the treatment of dementia-related psychosis, which we plan to commence in the first half of 2022."

    About KarXT

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

    About Karuna

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

    Forward Looking Statements

    This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about the timing of advancing of our planned clinical trials and regulatory filings, our goals to develop and commercialize our product candidates, and other statements identified by words such as "could," "expects," "intends," "may," "plans," "potential," "should," "will," "would," or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to obtain necessary funding, our ability to generate positive clinical trial results for our product candidates and other risks inherent in clinical development, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, risks relating to business interruptions resulting from the coronavirus (COVID-19) pandemic, and other risks set forth under the heading "Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2020. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.

    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 26 therapeutics and therapeutic candidates, including two that have received FDA clearance and European marketing authorization, as of the date of PureTech's most recently filed Annual Report on Form 20-F. 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 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, expectations regarding the potential of KarXT and those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

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  3. Company to initiate a Phase 2 trial evaluating KarXT in dementia-related psychosis in the first half of 2022

    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

    The majority of healthy elderly volunteers in the Phase 1b trial were titrated to xanomeline doses of 150 to 200 mg when dosed with KarXT

    Safety and tolerability profile in Phase 1b trial in healthy elderly volunteers consistent with prior trials of KarXT

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative…

    Company to initiate a Phase 2 trial evaluating KarXT in dementia-related psychosis in the first half of 2022

    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

    The majority of healthy elderly volunteers in the Phase 1b trial were titrated to xanomeline doses of 150 to 200 mg when dosed with KarXT

    Safety and tolerability profile in Phase 1b trial in healthy elderly volunteers consistent with prior trials of KarXT

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced data from its completed Phase 1b trial evaluating the safety and tolerability of KarXT (xanomeline-trospium) in healthy elderly volunteers. The Company had previously announced a preliminary analysis of data from the first two cohorts in the trial earlier this year. Based on results from the Phase 1b trial in healthy elderly volunteers, the Company plans to initiate a Phase 2 trial evaluating KarXT in dementia-related psychosis in the first half of 2022.

    The placebo-controlled, inpatient Phase 1b dose-ranging trial consisted of three cohorts, each enrolling 16 healthy elderly volunteers, randomized 3:1 to receive KarXT or placebo. As part of the flexible dosing protocol, a volunteer's dose was increased if they were tolerating KarXT well at the time of the potential dose increase, as determined by a clinician. In the trial, the majority of healthy elderly volunteers were titrated to xanomeline doses of 150 to 200 mg when dosed with KarXT three times per day. As previously reported, pharmacokinetic data from Cohorts 1 and 2 demonstrated that healthy elderly volunteers achieved mean xanomeline blood levels comparable to, or slightly higher than, the mean xanomeline blood levels reported in the Phase 2 EMERGENT-1 trial evaluating KarXT in adults with schizophrenia. The Company plans to evaluate pharmacokinetic data from Cohort 3, once available. Previous trials of KarXT have demonstrated that the current formulation of KarXT results in xanomeline exposures, or blood levels, that are approximately 10% greater than blood levels seen in earlier trials of xanomeline alone.

    The treatment-related adverse events (AEs) were similar to those observed in prior trials of KarXT, and a majority (>80%) were rated mild in severity. One serious AE of urinary retention was reported in Cohort 1. The Company believes the report of urinary retention was related to a higher dose of trospium used in Cohort 1 compared to doses used in Cohorts 2 and 3, where urinary retention was not observed. No serious or severe AEs were observed in Cohorts 2 and 3. Consistent with prior trials of KarXT, blood pressure in healthy elderly volunteers receiving KarXT was similar to placebo, and no syncopal events were observed. Heart rate increases observed in the trial were also consistent with prior trials of KarXT.

    Data from the Phase 1b trial 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.

    "We are encouraged that the data from our Phase 1b healthy elderly volunteers trial suggest that potentially therapeutic doses of KarXT can be administered to elderly adults while maintaining a favorable tolerability profile," said Stephen Brannan, M.D., chief medical officer of Karuna Therapeutics. "Results from the third cohort provide additional data as we finalize the dosing and titration protocol for our Phase 2 trial in dementia-related psychosis."

    "The results from the Phase 1b trial in healthy elderly volunteers, as well as a prior Phase 2 study demonstrating the potential of xanomeline to treat and prevent psychosis in patients with Alzheimer's disease, give us confidence in the potential utility of KarXT for the treatment of dementia-related psychosis," added Steve Paul, M.D., chief executive officer, president and chairman of the board of Karuna Therapeutics. "These results support the progression of KarXT into a Phase 2 clinical trial for the treatment of dementia-related psychosis, which we plan to commence in the first half of 2022."

    About KarXT

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

    About Karuna

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

    Forward Looking Statements

    This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about the timing of advancing of our planned clinical trials and regulatory filings, our goals to develop and commercialize our product candidates, and other statements identified by words such as "could," "expects," "intends," "may," "plans," "potential," "should," "will," "would," or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to obtain necessary funding, our ability to generate positive clinical trial results for our product candidates and other risks inherent in clinical development, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, risks relating to business interruptions resulting from the coronavirus (COVID-19) pandemic, and other risks set forth under the heading "Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2020. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.

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  4. Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced that senior management will present at the following upcoming virtual investor conferences:

    Goldman Sachs 42nd Annual Global Healthcare Conference
    Date: Tuesday, June 8, 2021
    Time: 1:20 p.m. ET

    JMP Securities Life Sciences Conference
    Date: Thursday, June 17, 2021
    Time: 4:00 p.m. ET

    A live webcast of the presentations will be available on the Investor Relations page of Karuna's website at investors.karunatx.com. A replay of the webcasts will also be archived for up to 30 days on Karuna's website following the conference.

    About

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced that senior management will present at the following upcoming virtual investor conferences:

    Goldman Sachs 42nd Annual Global Healthcare Conference

    Date: Tuesday, June 8, 2021

    Time: 1:20 p.m. ET

    JMP Securities Life Sciences Conference

    Date: Thursday, June 17, 2021

    Time: 4:00 p.m. ET

    A live webcast of the presentations will be available on the Investor Relations page of Karuna's website at investors.karunatx.com. A replay of the webcasts will also be archived for up to 30 days on Karuna's website following the conference.

    About Karuna Therapeutics

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

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  5. Three Phase 3 trials – EMERGENT-2, EMERGENT-3 and EMERGENT-4 – evaluating KarXT for the treatment of psychosis in adults with schizophrenia are currently enrolling

    On track to complete third cohort in Phase 1b trial evaluating KarXT in healthy elderly volunteers in the second quarter of 2021

    Patents granted on co-formulation compositions of KarXT, extending exclusivity through 2039

    $571.3 million in cash expected to fund operations, including multiple milestones, for at least 12 months following the potential New Drug Application (NDA) submission of KarXT in schizophrenia

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric…

    Three Phase 3 trials – EMERGENT-2, EMERGENT-3 and EMERGENT-4 – evaluating KarXT for the treatment of psychosis in adults with schizophrenia are currently enrolling

    On track to complete third cohort in Phase 1b trial evaluating KarXT in healthy elderly volunteers in the second quarter of 2021

    Patents granted on co-formulation compositions of KarXT, extending exclusivity through 2039

    $571.3 million in cash expected to fund operations, including multiple milestones, for at least 12 months following the potential New Drug Application (NDA) submission of KarXT in schizophrenia

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced financial results for the first quarter of 2021 and provided a general business update.

    "This year is off to a very productive start, with the advancement of our early- and late-stage clinical programs, most notably the initiation and ongoing enrollment of three Phase 3 trials in our EMERGENT program, the clinical program evaluating KarXT, our lead product candidate, in schizophrenia," said Steve Paul, M.D., chief executive officer, president and chairman. "We believe KarXT represents a major advance in the treatment of neuropsychiatric conditions, such as schizophrenia and dementia-related psychosis, where symptoms of psychosis are prominent and disabling. We look forward to furthering our journey to improve the lives of those living with these conditions."

    Pipeline Updates

    KarXT (xanomeline-trospium) is an oral investigational antipsychotic with a novel mechanism of action mediated via muscarinic cholinergic receptors. KarXT is currently being evaluated as a potential treatment for psychiatric disorders, including schizophrenia and dementia-related psychosis.

    • KarXT for the treatment of psychosis in adults with schizophrenia. The U.S. Food & Drug Administration has indicated that the previously completed positive Phase 2 five-week, inpatient safety and efficacy trial (EMERGENT-1), one successful Phase 3 efficacy and safety trial, and additional safety data would be acceptable to support a New Drug Application (NDA) filing in schizophrenia.
      • The Phase 3 EMERGENT-2, EMERGENT-3 and EMERGENT-4 trials are currently enrolling. The Phase 3 EMERGENT-5 trial remains on track to initiate in the second quarter of 2021.
      • The EMERGENT program includes the following Phase 3 trials:
        • EMERGENT-2: A five-week inpatient trial evaluating the efficacy and safety of KarXT compared to placebo in 246 adults with schizophrenia in the U.S.
        • EMERGENT-3: A five-week inpatient trial evaluating the efficacy and safety of KarXT compared to placebo in 246 adults with schizophrenia in the U.S. and Ukraine.
        • EMERGENT-4: A 52-week outpatient, open-label extension trial evaluating the long-term safety and tolerability of KarXT in 350 adults with schizophrenia who completed EMERGENT-2 or EMERGENT-3.
        • EMERGENT-5: A 52-week outpatient, open-label trial evaluating the long-term safety and tolerability of KarXT in 400 adults with schizophrenia in the U.S. in patients who were not enrolled in EMERGENT-2 or EMERGENT-3.
    • KarXT for the treatment of schizophrenia in adults who experience an inadequate response to standard of care. The Company plans to initiate a Phase 2 trial evaluating the potential of KarXT to improve symptoms of schizophrenia in adults who have not achieved an adequate response on their current antipsychotic treatment. This trial will evaluate the safety and efficacy of KarXT when dosed with background antipsychotic treatment, and is expected to initiate in the second half of 2021.
      • Data highlighting the antipsychotic activity of xanomeline in combination with an atypical antipsychotic in pre-clinical models of psychosis will be presented at the 2021 American Society of Clinical Psychopharmacology in June. The poster presentation will include data demonstrating xanomeline's, the active ingredient in KarXT, augmentation of ineffective doses of an atypical antipsychotic in a pre-clinical model.
    • KarXT for the treatment of dementia-related psychosis. The multi-cohort, placebo-controlled Phase 1b dose-ranging trial evaluating the safety and tolerability of KarXT in healthy elderly volunteers is ongoing.
      • Data from Cohort 3 of the Phase 1b trial in healthy elderly volunteers is expected in the second quarter of 2021. Based on interim data from Cohorts 1 and 2, previously reported in the first quarter of 2021, the Company believes that potentially therapeutic doses of KarXT can be administered to elderly adults while maintaining a favorable tolerability profile, providing a path to a Phase 2 trial evaluating KarXT in dementia-related psychosis. Cohort 3 will serve to further refine the dose range of xanomeline and trospium and the titration protocol. Planning for this Phase 2 trial in dementia-related psychosis has commenced and the Company expects to provide further guidance following the completion of Cohort 3 later this year.

    Business Updates

    • The Company completed a successful follow-on offering in the first quarter of 2021. The follow-on public offering resulted in net proceeds of $270.0 million after deducting underwriting discounts and commissions, and other offering related expenses.
    • The United States Patent and Trademark Office (USPTO) granted two patents in the first quarter of 2021, with September 2039 patent expiration dates and the potential for patent term extension. The USPTO granted US Patent Nos. 10,933,020 and 10,925,832 related to compositions and methods for treating disorders ameliorated by muscarinic receptor activation.
    • COVID-19 update. The Company continues to monitor the impact of COVID-19 on operations and will provide relevant updates on its impact on activities as deemed appropriate.

    First Quarter 2021 Financial Results

    The Company reported a net loss of $30.5 million for the first quarter of 2021, as compared to $8.7 million for the prior year period. The increase in net loss for the quarter was due to higher research and development expenses related to the Company's preparation, initiation and enrollment of the Phase 3 clinical trials within its EMERGENT program, NDA-supporting activities such as manufacturing, and increased employee headcount across the organization.

    Research and development expenses were $20.2 million for the first quarter of 2021, as compared to $4.4 million the prior year period. The increase in research and development expenses for the quarter was primarily driven by expenses related to the Company's preparation, initiation and enrollment of the Phase 3 clinical trials within the EMERGENT program, expenses related to manufacturing in preparation for a potential NDA submission, increased spend on the Company's discovery programs and increased personnel-related costs due to the increase in employee headcount.

    General and administrative expenses were $9.8 million for the first quarter of 2021, as compared to $5.6 million for the prior year period. The increase in general and administrative expenses was primarily due to an increase in employee headcount.

    The Company ended the quarter with $571.3 million in cash, cash equivalents and available-for-sale investment securities compared to $322.3 million as of December 31, 2020. The increase was the result of the completion of the Company's public offering. The Company expects that current cash, cash equivalents and available-for-sale investment securities as of March 31, 2021, will enable the Company to fund its operating expenses and capital expenditure requirements for at least 12 months following the potential NDA submission of KarXT for the treatment of psychosis in adults with schizophrenia.

    About Karuna Therapeutics

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

    Forward Looking Statements

    This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about the timing of advancing of our planned clinical trials and regulatory filings, our goals to develop and commercialize our product candidates, our identification of additional product candidates, our liquidity and capital resources and other statements identified by words such as "could," "expects," "intends," "may," "plans," "potential," "should," "will," "would," or similar expressions and the negatives of those terms. Forward looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to obtain necessary funding, our ability to generate positive clinical trial results for our product candidates and other risks inherent in clinical development, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, risks relating to business interruptions resulting from the coronavirus (COVID-19) pandemic, and other risks set forth under the heading "Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2020. Our actual results could differ materially from the results described in or implied by such forward looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.

    Karuna Therapeutics, Inc.

    Unaudited Consolidated Statements of Operations

    (in thousands, except share and per share data)

     

     

     

    Three Months Ended

    March 31,

     

     

     

     

    2021

     

     

    2020

     

     

    Revenue

     

     

     

     

     

     

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    20,186

     

     

    $

    4,420

     

     

    General and administrative

     

     

    9,777

     

     

     

    5,635

     

     

    Total operating expenses

     

     

    29,963

     

     

     

    10,055

     

     

    Loss from operations

     

     

    (29,963

    )

     

     

    (10,055

    )

     

    Other income (loss), net:

     

     

     

     

     

     

     

     

     

    Impairment loss on right-of-use assets

     

     

    (677)

     

     

     

     

     

    Interest income

     

     

    143

     

     

     

    1,397

     

     

    Total other income (loss), net

     

     

    (534)

     

     

     

    1,397

     

     

    Net loss before income taxes

     

     

    (30,497

    )

     

     

    (8,658

    )

     

    Income tax provision

     

     

     

     

     

     

     

    Net loss attributable to common stockholders

     

    $

    (30,497

    )

     

    $

    (8,658

    )

     

    Net loss per share, basic and diluted

     

    $

    (1.10

    )

     

    $

    (0.33

    )

     

    Weighted average common shares outstanding used in computing net loss per share, basic and diluted

     

     

    27,786,538

     

     

     

    26,042,434

     

     

    Karuna Therapeutics, Inc.

    Unaudited Consolidated Balance Sheet Data

    (in thousands)

     

     

     

    March 31,

    2021

     

     

    December 31,

    2020

     

    Cash, cash equivalents and investments

     

    $

    571,295

     

     

    $

    322,330

     

    Working capital

     

     

    583,390

     

     

     

    337,746

     

    Total assets

     

     

    593,264

     

     

     

    347,625

     

    Total stockholders' equity

     

    $

    584,914

     

     

    $

    338,931

     

     

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