KRTX Karuna Therapeutics Inc.

124.51
-0.26  -0%
Previous Close 124.77
Open 119
52 Week Low 52.62
52 Week High 146.97
Market Cap $3,364,102,570
Shares 27,018,734
Float 12,368,552
Enterprise Value $3,007,736,487
Volume 893,399
Av. Daily Volume 184,131
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Upcoming Catalysts

Drug Stage Catalyst Date
KarXT
Healthy elderly volunteers / dementia-related psychosis
Phase 1b
Phase 1b
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Drug Pipeline

Drug Stage Notes
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. 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 Therapeutics, Inc. (NASDAQ:KRTX) ("Karuna"), announced the pricing of an underwritten public offering of 2,083,334 shares of its common stock at a public offering price of $120.00 per share. The gross proceeds to Karuna from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $250.0 million. In addition, Karuna has granted the underwriters a 30-day option to purchase up…

    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 Therapeutics, Inc. (NASDAQ:KRTX) ("Karuna"), announced the pricing of an underwritten public offering of 2,083,334 shares of its common stock at a public offering price of $120.00 per share. The gross proceeds to Karuna from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $250.0 million. In addition, Karuna has granted the underwriters a 30-day option to purchase up to an additional 312,500 shares of common stock. The offering is expected to close on or about March 4, 2021, subject to customary closing conditions. All the shares in the proposed offering are to be sold by Karuna.

    Goldman Sachs & Co. LLC and J.P. Morgan are acting as joint book-running managers for the offering. Stifel is also acting as a book-running manager. JMP Securities and Wedbush PacGrow are acting as co-managers for the offering.

    The shares are being offered by Karuna pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission.

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

    Karuna Therapeutics Announces Pricing of Public Offering of Common Stock

    BOSTON, March 1, 2021 – Karuna Therapeutics, Inc. (NASDAQ:KRTX) ("Karuna"), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced the pricing of an underwritten public offering of 2,083,334 shares of its common stock at a public offering price of $120.00 per share. The gross proceeds to Karuna from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $250.0 million. In addition, Karuna has granted the underwriters a 30-day option to purchase up to an additional 312,500 shares of common stock. The offering is expected to close on or about March 4, 2021, subject to customary closing conditions. All the shares in the proposed offering are to be sold by Karuna.

    Goldman Sachs & Co. LLC and J.P. Morgan are acting as joint book-running managers for the offering. Stifel is also acting as a book-running manager. JMP Securities and Wedbush PacGrow are acting as co-managers for the offering.

    The shares are being offered by Karuna pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC's website at www.sec.gov.

    When available, copies of the final prospectus supplement relating to these securities may also be obtained from the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at ; or J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    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 among other things, the timing and completion of the public offering, 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. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, market risks and the satisfaction of customary closing conditions for an offering of securities. These and other risks are described under the heading "Risk Factors" in Karuna's most recent Annual Report on Form 10-K filed with the SEC and in other filings that Karuna makes with the SEC. Karuna's 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, Karuna undertakes no obligation to update or revise these forward-looking statements.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains statements that are or may be forward-looking statements, including statements that relate to our product candidates and approach towards addressing major diseases and the timing and completion of the public offering by our Founded Entity Karuna Therapeutics, Inc.. 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 timing and completion of Karuna's public offering 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 IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF THAT JURISDICTION.

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  2. Karuna Therapeutics, Inc. (NASDAQ:KRTX) ("Karuna"), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced the pricing of an underwritten public offering of 2,083,334 shares of its common stock at a public offering price of $120.00 per share. The gross proceeds to Karuna from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $250.0 million. In addition, Karuna has granted the underwriters a 30-day option to purchase up to an additional 312,500 shares of common stock. The offering is expected to close on or about March 4, 2021…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX) ("Karuna"), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced the pricing of an underwritten public offering of 2,083,334 shares of its common stock at a public offering price of $120.00 per share. The gross proceeds to Karuna from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $250.0 million. In addition, Karuna has granted the underwriters a 30-day option to purchase up to an additional 312,500 shares of common stock. The offering is expected to close on or about March 4, 2021, subject to customary closing conditions. All the shares in the proposed offering are to be sold by Karuna.

    Goldman Sachs & Co. LLC and J.P. Morgan are acting as joint book-running managers for the offering. Stifel is also acting as a book-running manager. JMP Securities and Wedbush PacGrow are acting as co-managers for the offering.

    The shares are being offered by Karuna pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC's website at www.sec.gov.

    When available, copies of the final prospectus supplement relating to these securities may also be obtained from the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at ; or J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    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 among other things, the timing and completion of the public offering, 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. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, market risks and the satisfaction of customary closing conditions for an offering of securities. These and other risks are described under the heading "Risk Factors" in Karuna's most recent Annual Report on Form 10-K filed with the SEC and in other filings that Karuna makes with the SEC. Karuna's 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, Karuna undertakes no obligation to update or revise these forward-looking statements.

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  3. Karuna Therapeutics, Inc. (NASDAQ:KRTX) ("Karuna"), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced that it has commenced an underwritten public offering of $200.0 million of its common stock. Karuna also intends to grant the underwriters a 30-day option to purchase an additional $30.0 million of its common stock offered in the public offering. All the shares in the proposed offering are to be sold by Karuna.

    Goldman Sachs & Co. LLC and J.P. Morgan are acting as joint book-running managers for the offering. Stifel is also acting as a book-running manager. The offering is subject to market and other conditions, and…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX) ("Karuna"), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced that it has commenced an underwritten public offering of $200.0 million of its common stock. Karuna also intends to grant the underwriters a 30-day option to purchase an additional $30.0 million of its common stock offered in the public offering. All the shares in the proposed offering are to be sold by Karuna.

    Goldman Sachs & Co. LLC and J.P. Morgan are acting as joint book-running managers for the offering. Stifel is also acting as a book-running manager. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    The shares are being offered by Karuna pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov.

    When available, copies of the preliminary prospectus supplement relating to these securities may also be obtained from the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at ; or J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at . The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    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 among other things, the timing, size and completion of the proposed public offering, 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. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, market risks, the final terms of the offering, and uncertainties and the satisfaction of customary closing conditions for an offering of securities. These and other risks are described under the heading "Risk Factors" in Karuna's most recent Annual Report on Form 10-K filed with the SEC and in other filings that Karuna makes with the SEC. Karuna's 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, Karuna undertakes no obligation to update or revise these forward-looking statements.

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  4. Two Phase 3 trials, EMERGENT-2 and EMERGENT-4, initiated evaluating KarXT for the treatment of psychosis in adults with schizophrenia

    Results from the Phase 2 EMERGENT-1 clinical trial of KarXT in schizophrenia published in the New England Journal of Medicine

    First two cohorts from Phase 1b trial in healthy elderly volunteers complete, with results from Cohort 3 expected in the second quarter of 2021

    Patent exclusivity granted on co-formulation compositions of KarXT through 2039

    $322.3 million in cash, cash equivalents and available-for-sale investments expected to fund multiple potential milestones, including the completion of EMERGENT program and subsequent New Drug Application (NDA) submission

    Karuna Therapeutics, Inc. (NASDAQ:KRTX

    Two Phase 3 trials, EMERGENT-2 and EMERGENT-4, initiated evaluating KarXT for the treatment of psychosis in adults with schizophrenia

    Results from the Phase 2 EMERGENT-1 clinical trial of KarXT in schizophrenia published in the New England Journal of Medicine

    First two cohorts from Phase 1b trial in healthy elderly volunteers complete, with results from Cohort 3 expected in the second quarter of 2021

    Patent exclusivity granted on co-formulation compositions of KarXT through 2039

    $322.3 million in cash, cash equivalents and available-for-sale investments expected to fund multiple potential milestones, including the completion of EMERGENT program and subsequent New Drug Application (NDA) submission

    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 fourth quarter and year ended 2020 and provided a general business update.

    "This past year was foundational for Karuna. We realized significant milestones and achievements including the initiation of the first Phase 3 trial in our EMERGENT program evaluating our lead asset, KarXT, in schizophrenia, the expansion of our internal drug discovery efforts, as well as establishing multiple strategic collaborations. We have experienced significant growth in our organization as we've nearly tripled in size to support our ongoing efforts and evolution to a late-stage clinical biotech company," said Steve Paul, M.D., chief executive officer, president and chairman. "2021 is off to a great start with the initiation of our Phase 3 EMERGENT-4 clinical trial and the recent publication in the New England Journal of Medicine of our positive Phase 2 EMERGENT-1 data, insights from the first two cohorts of our Phase 1b trial in healthy volunteers, and our recently issued patent extending exclusivity of KarXT through at least 2039."

    "Looking ahead, 2021 is expected to be a year of execution and expansion for Karuna, as we anticipate having comprehensive registrational EMERGENT program for schizophrenia underway within the first half of the year, initiating a Phase 2 trial evaluating KarXT in adults with schizophrenia who inadequately respond to standard of care in the second half of 2021, and exploring KarXT's potential to treat dementia-related psychosis pending results from the third cohort of our ongoing Phase 1b dose-ranging trial in healthy elderly volunteers," Dr. Paul commented further. "These milestones and activities represent great progress in our journey to potentially deliver a completely novel treatment for those living with schizophrenia and other serious neuropsychiatric conditions."

    "We're encouraged by the preliminary analysis of data from the first two completed cohorts in the Phase 1b healthy elderly volunteers trial. In this trial, healthy elderly volunteers achieved mean xanomeline blood levels comparable to, or slightly higher than, the mean xanomeline blood level reported in our EMERGENT-1 trial, which demonstrated clinically meaningful reduction of symptoms of psychosis in adults with schizophrenia," said Stephen Brannan, M.D., chief medical officer. "Data from the two completed cohorts suggest that a lower ratio of trospium to xanomeline, compared to the ratios used in trials in healthy adult volunteers and in adults with schizophrenia, was better tolerated by healthy elderly volunteers. Thus, we believe that potentially therapeutic doses of KarXT can be administered to elderly adults using titration and flexible dosing while maintaining a favorable tolerability profile, providing a path to a Phase 2 trial evaluating KarXT in dementia-related psychosis."

    Pipeline Updates

    KarXT, a proprietary oral modulator of muscarinic cholinergic receptors, is Karuna's lead product candidate combining xanomeline, a novel muscarinic agonist, with trospium, a U.S. Food & Drug Administration approved muscarinic antagonist that does not appreciably cross the blood-brain-barrier, to preferentially stimulate muscarinic receptors in the central nervous system. KarXT is currently being evaluated as a potential treatment for neuropsychiatric conditions, including schizophrenia and dementia-related psychosis.

    • KarXT in schizophrenia. The EMERGENT program, the clinical program evaluating KarXT for the treatment of acute psychosis in adults with schizophrenia, is underway. The EMERGENT program includes the previously completed positive Phase 2 efficacy and safety trial (EMERGENT-1), two Phase 3 trials evaluating efficacy and safety (EMERGENT-2 & EMERGENT-3), and two Phase 3 trials evaluating the long-term safety of KarXT (EMERGENT-4 & EMERGENT-5).
      • The Company initiated EMERGENT-2 and EMERGENT-4 in December 2020 and the first quarter of 2021, respectively. EMERGENT-3 and EMERGENT-5, the remaining trials in the EMERGENT program, are on track to initiate in the first half of 2021.
      • The Company remains on track to initiate a Phase 2 trial evaluating KarXT for the treatment of psychosis in patients with schizophrenia who have an inadequate response to current standard of care therapies in the second half of 2021. The trial will evaluate the efficacy and safety of KarXT when dosed in conjunction with background antipsychotic treatment and its potential to improve symptoms in patients who have not achieved an adequate response on their current antipsychotic treatment.
      • Results from EMERGENT-1 published in the New England Journal of Medicine (NEJM). The published manuscript titled "Muscarinic Cholinergic Receptor Agonist and Peripheral Antagonist for Schizophrenia," is available online, and appears in the February 25, 2021 issue of NEJM.
    • KarXT in dementia-related psychosis. The multi-cohort, placebo-controlled, inpatient Phase 1b dose-ranging trial evaluating the safety and tolerability of KarXT in healthy elderly volunteers is ongoing. The Company completed the first two cohorts in this trial, Cohorts 1 and 2, and expects data from the final cohort, Cohort 3, in the second quarter of 2021.
      • The Company has completed data collection from Cohorts 1 and 2. The two completed cohorts in the ongoing Phase 1b trial consisted of 16 healthy elderly volunteers each, 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 the clinician.
      • In both cohorts, healthy elderly volunteers achieved mean xanomeline blood levels comparable to, or slightly higher than, the mean xanomeline blood levels reported in the EMERGENT-1 trial, which demonstrated a statistically significant reduction in total PANSS score in adults with schizophrenia. The majority of healthy elderly volunteers in both cohorts were titrated to xanomeline doses of 150 to 200 mg when dosed with KarXT three times per day. Data from the two completed cohorts suggest that a lower dose ratio of trospium to xanomeline, compared to the ratios used in trials in healthy adult volunteers and in adults with schizophrenia, was better tolerated by healthy elderly volunteers.
      • The cholinergic and anticholinergic adverse events (or AEs) seen in Cohorts 1 and 2 were similar to those observed in prior trials of KarXT. The vast majority of AEs (>80%) were rated as mild. No syncopal events were observed. In Cohort 1, one serious adverse event (SAE) of urinary retention was reported related to the higher dose of trospium used in this cohort. In Cohort 2, which utilized a lower trospium dose, all AEs were rated mild or moderate in severity and there were no SAEs.
      • Based on data from Cohorts 1 and 2, 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 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 United States Patent and Trademark Office (USPTO) granted a new patent, extending exclusivity through 2039 with potential for patent term extension. USPTO granted US Patent No. 10,925,832 related to compositions and methods for treating disorders ameliorated by muscarinic receptor activation, with an expiration date of September 27, 2039. This patent is directed to co-formulation compositions, dose levels of xanomeline and trospium, and pharmacokinetics.
    • Strengthened Board of Directors and management team through key appointments. In December 2020, the Company announced the appointments of David Wheadon, M.D., former Senior Vice President, Global Regulatory Affairs, Patient Safety and Quality Assurance at AstraZeneca Pharmaceuticals, and Denice Torres, J.D., former Chief Strategy and Business Transformation Officer for the Medical Device division of Johnson & Johnson, to the Board of Directors. In January 2021, the Company appointed Ron Marcus, M.D., as Senior Vice President of Medical. In this role, Dr. Marcus will provide strategic and operational leadership of Karuna's clinical stage pipeline of novel neuropsychiatric medicines, including KarXT.
    • 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.

    Fourth Quarter and Full Year 2020 Financial Results

    The Company reported a net loss of $24.0 million for the fourth quarter 2020, and a net loss of $68.6 million for the year ended 2020, as compared to $7.8 million and $44.0 million for the prior year periods, respectively. The increase in net loss for the year was due to higher research and development expenses related to the Company's preparation and initiation of the Phase 3 clinical trials within its EMERGENT program, increased employee headcount across the organization, and increased general and administrative expenses due to the impact of operating as a public company for the full year in 2020 relative to a partial year in 2019.

    Research and development expenses were $15.6 million for the fourth quarter 2020, and $43.4 million for the year ended 2020, as compared to $5.0 million and $24.5 million for the prior year periods, respectively. The increase in research and development expenses for the year was primarily driven by expenses related to the Company's initiation of EMERGENT-2, and preparation for the initiation of the remaining Phase 3 trials within the EMRGENT program. The Company had additional expenses related to its Phase 1b trial in healthy elderly volunteers, increased personnel-related costs due to the increase in employee headcount, as well as expenses associated with the Company's discovery programs.

    General and administrative expenses were $8.8 million for the fourth quarter 2020, and $28.4 million for the year ended 2020, as compared to $3.9 million and $20.9 million for the prior year periods, respectively. The increase in general and administrative expenses was primarily due to the impact of operating as a public company for the full year in 2020 relative to a partial year in 2019, as well as an increase in employee headcount.

    The Company ended the year 2020 with $322.3 million in cash, cash equivalents and available-for-sale investment securities compared to $389.4 million as of December 31, 2019. The Company expects that current cash, cash equivalents, and available-for-sale investment securities as of December 31, 2020, will enable the Company to fund its operating expenses and capital expenditure requirements into 2023. This includes multiple potential clinical and development milestones, including an NDA submission of KarXT for the treatment of acute psychosis in patients with schizophrenia pending the outcomes of the Company's planned EMERGENT clinical trials. Additional activities which may be funded include the initiation of the potential Phase 2 trial for the treatment of dementia-related psychosis and continued investment into pipeline expansion, including evaluating KarXT in patients with schizophrenia who have an inadequate response to standard of care therapies.

    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

    December 31,

     

     

    Twelve Months Ended

    December 31,

     

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenue

     

     

     

     

     

     

     

     

     

     

     

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    15,584

     

     

    $

    4,992

     

     

    $

    43,408

     

     

    $

    24,536

     

    General and administrative

     

     

    8,823

     

     

     

    3,874

     

     

     

    28,408

     

     

     

    20,869

     

    Total operating expenses

     

     

    24,407

     

     

     

    8,866

     

     

     

    71,816

     

     

     

    45,405

     

    Loss from operations

     

     

    (24,407

    )

     

     

    (8,866

    )

     

     

    (71,816

    )

     

     

    (45,405

    )

    Other income, net:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Interest income

     

     

    441

     

     

     

    1,092

     

     

     

    3,305

     

     

     

    2,517

     

    Interest income, net

     

     

     

     

     

     

     

     

     

     

     

    11

     

    Accretion of debt discount

     

     

     

     

     

     

     

     

     

     

     

    (945

    )

    Change in fair value of derivative

     

     

     

     

     

     

     

     

     

     

     

    (135

    )

    Total other income, net

     

     

    441

     

     

     

    1,092

     

     

     

    3,305

     

     

     

    1,448

     

    Net loss before income taxes

     

     

    (23,966

    )

     

     

    (7,774

    )

     

     

    (68,511

    )

     

     

    (43,957

    )

    Income tax provision

     

     

    (43)

     

     

     

     

     

     

    (43)

     

     

     

     

    Net loss attributable to common stockholders

     

    $

    (24,009

    )

     

    $

    (7,774

    )

     

    $

    (68,554

    )

     

    $

    (43,957

    )

    Net loss per share, basic and diluted

     

    $

    (0.89

    )

     

    $

    (0.32

    )

     

    $

    (2.59

    )

     

    $

    (3.68

    )

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

     

     

    26,883,923

     

     

     

    24,430,145

     

     

     

    26,446,006

     

     

     

    11,958,152

     

     

    Karuna Therapeutics, Inc.

    Unaudited Consolidated Balance Sheet Data

    (in thousands)

     

     

     

    December

    31,

    2020

     

     

    December

    31,

    2019

     

    Cash, cash equivalents and available-for-sale investments

     

    $

    322,330

     

     

    $

    389,397

     

    Working capital

     

     

    337,746

     

     

     

    389,748

     

    Total assets

     

     

    347,625

     

     

     

    393,024

     

    Total stockholders' equity

     

    $

    338,931

     

     

    $

    389,916

     

     

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

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

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

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

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

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

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

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

    The published manuscript titled "Muscarinic Cholinergic Receptor Agonist and Peripheral Antagonist for Schizophrenia" is available online and appears in the February 25, 2021 issue of NEJM.

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

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

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

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

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

    BOSTON, February 24, 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 that results from the EMERGENT-1 Phase 2 clinical trial evaluating KarXT for the treatment of schizophrenia were published in the New England Journal of Medicine (NEJM).

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

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

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

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

    The published manuscript titled "Muscarinic Cholinergic Receptor Agonist and Peripheral Antagonist for Schizophrenia," is available online, and will appear in the February 25, 2021 issue of NEJM.

    About KarXT

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

    About Schizophrenia

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

    About Karuna

    Karuna Therapeutics is a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions. At Karuna, we understand there is a need for differentiated and more effective treatments that can help patients navigate the challenges presented by these severe and disabling disorders. Utilizing our extensive knowledge of neuroscience, we are harnessing the untapped potential of the brain in pursuit of novel pathways to develop medicines that make meaningful differences in peoples' lives. 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, 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, 2019 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 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 intractable cancers, lymphatic and gastrointestinal diseases, central nervous system disorders and inflammatory and immunological diseases, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech's Founded Entities, as of the date of PureTech's most recently filed Registration Statement on Form 20-F, was comprised of 24 products and product candidates, including two that have received FDA clearance and European marketing authorization. All of the underlying programs and platforms that resulted in this pipeline of product candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Company's unique insights into the biology of the brain, immune and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.

    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, our expectations regarding the potential therapeutic benefits of our product candidates, our expectations regarding the results from Karuna's EMERGENT-1 Phase 2 clinical trial evaluating 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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