1. 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 Andrew Miller, Ph.D., chief operating officer and founder, will participate in a fireside chat at the ICR Conference 2021 on Thursday, January 14, 2021 at 3:15 p.m. EST.

    A live webcast of the presentation will be available on the Investor Relations page of Karuna's website at investors.karunatx.com. A replay of the webcast will also be archived for up to 90 days on Karuna's website following the conference.

    About Karuna Therapeutics
    Karuna Therapeutics is a clinical-stage biopharmaceutical company driven to create and deliver…

    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 Andrew Miller, Ph.D., chief operating officer and founder, will participate in a fireside chat at the ICR Conference 2021 on Thursday, January 14, 2021 at 3:15 p.m. EST.

    A live webcast of the presentation will be available on the Investor Relations page of Karuna's website at investors.karunatx.com. A replay of the webcast will also be archived for up to 90 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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  2. 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 Steve Paul, M.D., chief executive officer, president and chairman, will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021 at 10:50 a.m. EST.

    A live webcast of the presentation will be available on the Investor Relations page of Karuna's website at investors.karunatx.com. A replay of the webcast 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…

    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 Steve Paul, M.D., chief executive officer, president and chairman, will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021 at 10:50 a.m. EST.

    A live webcast of the presentation will be available on the Investor Relations page of Karuna's website at investors.karunatx.com. A replay of the webcast 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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  3. Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, today announced the appointment of Denice Torres, J.D., to its Board of Directors effective December 22, 2020.

    "Denice is a highly respected leader with an exceptional ability to visualize and achieve operational success by identifying inherent strengths within organizations and fostering diverse and collaborative cultures," said Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics. "Her expertise in leading companies through significant periods of change…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, today announced the appointment of Denice Torres, J.D., to its Board of Directors effective December 22, 2020.

    "Denice is a highly respected leader with an exceptional ability to visualize and achieve operational success by identifying inherent strengths within organizations and fostering diverse and collaborative cultures," said Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics. "Her expertise in leading companies through significant periods of change and growth will be invaluable as we enter this next stage in our evolution as a late-stage clinical biotech company following the recent initiation of our Phase 3 program. We look forward to Denice's contributions as we work towards our goal to develop and deliver meaningful treatment options for people living with disabling and potentially fatal neuropsychiatric disorders."

    "I'm truly pleased to join Karuna's board, particularly during this important inflection point for the company," said Ms. Torres. "The most successful organizations are those that are not only purpose-driven, but also leverage multidimensional thinking. Karuna exemplifies these qualities through their innovative approach to drug development, and their passionate team driven to deliver non-incremental advances in treatments for those living with severe neuropsychiatric disorders. I look forward to applying my leadership and commercial experience as Karuna enters this next period of growth, and contributing to the Company's efforts to deliver impactful medicines for those affected by psychiatric and neurological conditions."

    Ms. Torres brings more than 25 years of healthcare and pharmaceutical experience, most recently serving as the Chief Strategy and Business Transformation Officer for the Medical Device division of Johnson & Johnson. Ms. Torres held several leadership positions at Johnson & Johnson prior to this role, including President of McNeil Consumer Healthcare and President of Janssen Pharmaceuticals, CNS, among others. Before joining Johnson & Johnson, she held senior commercial leadership roles at Eli Lilly, including head of U.S. Women's Health, Global Neuroscience, and Growth Hormone. Ms. Torres has received numerous awards, including Healthcare Businesswomen's Association Woman of the Year, Johnson & Johnson Working Mother of the Year and the Johnson & Johnson H.O.N.O.R. Special Recognition Leadership Award for her work in diversity and inclusion.

    Following her career in the healthcare industry, Ms. Torres founded The Ignited Company, a change management consulting firm focused, and The Mentoring Place, a community-based platform that serves to help women navigate and grow their careers through educational courses and a mentorship program with top women executives and entrepreneurs.

    Ms. Torres serves on the Board of Directors of bluebird bio and National Resilience, Inc. She holds a B.S. in Psychology from Ball State, MBA from University of Michigan, and J.D. Law from Indiana University.

    About Karuna

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

    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, 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, 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, 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.

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  4. Ed Harrigan, M.D., to step down from Karuna's board and continue to serve on the Company's scientific advisory board

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, today announced the appointment of David Wheadon, M.D., to its Board of Directors. In addition, the Company announced that Ed Harrigan, M.D., will step down from the Board of Directors effective December 3, 2020. Dr. Harrigan will continue to serve as a member of the Company's scientific advisory board.

    "We are thrilled to welcome David to our Board of Directors," said Steve…

    Ed Harrigan, M.D., to step down from Karuna's board and continue to serve on the Company's scientific advisory board

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, today announced the appointment of David Wheadon, M.D., to its Board of Directors. In addition, the Company announced that Ed Harrigan, M.D., will step down from the Board of Directors effective December 3, 2020. Dr. Harrigan will continue to serve as a member of the Company's scientific advisory board.

    "We are thrilled to welcome David to our Board of Directors," said Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics. "David is a distinguished pharmaceutical leader with an extensive background in regulatory affairs, global health policy and clinical strategy. His successful track record in drug development, including several important neuropsychiatric medicines, provides an invaluable perspective as Karuna advances to late-stage clinical development and continues to grow a pipeline of novel neuropsychiatric therapies."

    "I am proud to join the board of Karuna and work alongside a passionate team that is uniquely steeped in neuroscience, with first-hand experience developing medicines for those living with disabling psychiatric disorders," stated Dr. Wheadon. "Karuna is entering an exciting phase in neuropsychiatric drug development, and I look forward to contributing to the Company's efforts in delivering meaningful treatment advancements for those affected by psychiatric and neurological conditions."

    Dr. Wheadon is a trained physician and psychiatrist with more than 30 years of industry experience in clinical development, public policy and regulatory affairs. Most recently Dr. Wheadon served as Senior Vice President, Global Regulatory Affairs, Patient Safety and Quality Assurance at AstraZeneca Pharmaceuticals. Prior to AstraZeneca, he held senior regulatory and clinical development leadership positions at Abbott, GlaxoSmithKline, Eli Lilly, the Juvenile Diabetes Research Foundation and the Pharmaceutical Research and Manufacturers of America (PhRMA). Dr. Wheadon is a board member of Assertio Holdings, Inc. He holds an A.B. in biology from Harvard College and an M.D. from Johns Hopkins University School of Medicine. He completed his fellowship training in psychiatry at Tufts New England Medical Center.

    "Ed has provided invaluable guidance and contributions to the clinical and corporate growth of Karuna since joining shortly after the Company's inception," stated Dr. Paul. "The Karuna board and management team extend our profound thanks to Ed for his leadership during these instrumental and formative years, and we look forward to our continued partnership with Ed as a member of our scientific advisory board."

    About Karuna

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

    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, 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, 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, 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.

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  5. Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, today announced that senior management will participate in a fireside chat at the Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17, 2020 at 2:40 p.m. EST.

    A live webcast of the fireside chat will be available on the Investor Relations page of Karuna's website at investors.karunatx.com. A replay of the webcast will also be archived for up to 90 days on Karuna's website following the conference.

    About Karuna

    Karuna is a clinical-stage biopharmaceutical company committed to developing…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, today announced that senior management will participate in a fireside chat at the Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17, 2020 at 2:40 p.m. EST.

    A live webcast of the fireside chat will be available on the Investor Relations page of Karuna's website at investors.karunatx.com. A replay of the webcast will also be archived for up to 90 days on Karuna's website following the conference.

    About Karuna

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

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  6. On track to initiate first Phase 3 trial within the EMERGENT program by the end of 2020

    Topline data from Phase 1b trial in healthy elderly volunteers expected early in the second quarter of 2021

    $344.9 million in cash, cash equivalents and investment securities expected to fund multiple milestones, including progressing KarXT to NDA submission, and operations for at least the next three years

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, today announced financial results for the third quarter of 2020 and provided a general business…

    On track to initiate first Phase 3 trial within the EMERGENT program by the end of 2020

    Topline data from Phase 1b trial in healthy elderly volunteers expected early in the second quarter of 2021

    $344.9 million in cash, cash equivalents and investment securities expected to fund multiple milestones, including progressing KarXT to NDA submission, and operations for at least the next three years

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, today announced financial results for the third quarter of 2020 and provided a general business update.

    "The end of this year will be transformative for Karuna as we initiate our Phase 3 EMERGENT program and transition to a late-stage clinical biotech company," said Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics. "We continue to grow the organization to support our corporate and development objectives, and remain focused on simultaneously advancing our discovery efforts and early- and late-stage clinical programs evaluating KarXT in neuropsychiatric disorders."

    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 (FDA) approved muscarinic antagonist that does not appreciably cross the blood-brain-barrier, to preferentially stimulate muscarinic receptors in the central nervous system (CNS). KarXT is currently being evaluated as a potential treatment for neuropsychiatric disorders, including schizophrenia and dementia-related psychosis.

    • KarXT in schizophrenia: The Company remains on track to initiate EMERGENT-2, the first Phase 3 trial within the Company's EMERGENT clinical program evaluating KarXT for the treatment of acute psychosis in adults with schizophrenia, by the end of 2020. The Company plans to initiate the remaining Phase 3 trials within the EMERGENT program in the first half of 2021.
      • Data highlighting details of efficacy, tolerability and safety from the Company's completed Phase 2 trial (EMERGENT-1) will be presented at the American College of Neuropsychopharmacology Annual Meeting scheduled for December. The presentation will include both efficacy and safety data, including new data on the duration of treatment emergent adverse events of KarXT versus placebo.
      • The Company plans 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. 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 had not achieved an adequate response on their current antipsychotic treatment given the unique mechanism of action of KarXT in comparison to existing standard of care therapies. The Company plans to start this trial following the initiation of the Phase 3 trials within the EMERGENT program.
      • An exploratory endpoint analysis evaluating the impact of KarXT on cognition in the EMERGENT-1 trial was presented at the European College of Neuropsychopharmacology Annual Meeting in September. The analysis demonstrated trends towards improvements in cognition for patients receiving KarXT relative to placebo, with larger benefits seen in patients with greater cognitive impairment at baseline. The Company plans to collect data on the potential benefit of KarXT on negative and cognitive symptoms of schizophrenia as part of the EMERGENT program and the Company's trial evaluating KarXT in patients who have an inadequate response to current standard of care therapies, and will continue to evaluate the timing and design of potential trials specifically directed towards the negative and cognitive symptoms of schizophrenia.
    • KarXT in dementia-related psychosis: The multi-cohort, placebo-controlled, inpatient Phase 1b trial evaluating the safety and tolerability of KarXT in healthy elderly volunteers is ongoing, with results anticipated early in the second quarter of 2021. The trial is designed to assess the safety and tolerability of KarXT in healthy elderly volunteers with the goal of selecting the most appropriate dose and dose-titration schedule to carry forward into future studies in patients with dementia-related psychosis.

    Business Updates

    • Laurie Olson appointed to Board of Directors. In August 2020, the Company's Board of Directors elected Laurie Olson as a director and as a member of its nominating and corporate governance committee. Ms. Olson is a seasoned pharmaceutical executive with more than 30 years of commercial and corporate strategy experience, most recently serving as the Executive Vice President, Strategy and Commercial Operations at Pfizer Inc.
    • COVID-19 update. The Company continues to monitor the impact of COVID-19 across all ongoing and planned clinical trials and will provide updates on enrollment and completion timelines as deemed appropriate.

    Third Quarter 2020 Financial Results

    The Company reported a net loss of $18.8 million for the third quarter of 2020, as compared to $9.0 million for the prior year period. The increase in net loss for the period was due to higher research and development expenses related to the Company's preparation for the initiation of the Phase 3 clinical trials within its EMERGENT program as well as higher general and administrative expense.

    Research and development expenses were $12.6 million for the third quarter of 2020, as compared to $5.8 million for the prior year period. The increase in research and development expenses for the period was primarily driven by expenses related to the Company's preparation for the initiation of the Phase 3 clinical trials within its EMERGENT program, including CRO start-up costs and clinical trial material manufacturing. The Company also 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 $6.9 million for the third quarter of 2020, as compared to $4.1 million for the prior year period. The increase in general and administrative expenses was primarily due to an increase in personnel-related expenses.

    The Company ended the quarter with $344.9 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 its current cash, cash equivalents, and available-for-sale investment securities as of September 30, 2020 will enable the Company to fund its operating expenses and capital expenditure requirements for at least the next three years. 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 and the completion of the Phase 1b healthy elderly trial. 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

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

    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, 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, 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, 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.

    Karuna Therapeutics, Inc.

    Unaudited Consolidated Statements of Operations

    (in thousands, except share and per share data)

     

     

    Three Months Ended

    September 30,

     

     

    Nine Months Ended

    September 30,

     

     

     

    2020 

     

     

     2019

     

     

    2020 

     

     

     2019

     

    Revenue

     

     

     

     

     

     

     

     

     

     

     

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    12,585

     

     

    $

    5,793

     

     

    $

    27,824

     

     

    $

    19,544

     

    General and administrative

     

     

    6,944

     

     

     

    4,103

     

     

     

    19,585

     

     

     

    16,995

     

    Total operating expenses

     

     

    19,529

     

     

     

    9,896

     

     

     

    47,409

     

     

     

    36,539

     

    Loss from operations

     

     

    (19,529

    )

     

     

    (9,896

    )

     

     

    (47,409

    )

     

     

    (36,539

    )

    Other income, net:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Interest income

     

     

    688

     

     

     

    858

     

     

     

    2,864

     

     

     

    1,425

     

    Interest income, net

     

     

     

     

     

     

     

     

     

     

     

    11

     

    Accretion of debt discount

     

     

     

     

     

     

     

     

     

     

     

    (945

    )

    Change in fair value of derivative

     

     

     

     

     

     

     

     

     

     

     

    (135

    )

    Total other income, net

     

     

    688

     

     

     

    858

     

     

     

    2,864

     

     

     

    356

     

    Net loss before income taxes

     

     

    (18,841

    )

     

     

    (9,038

    )

     

     

    (44,545

    )

     

     

    (36,183

    )

    Income tax provision

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss attributable to common stockholders

     

    $

    (18,841

    )

     

    $

    (9,038

    )

     

    $

    (44,545

    )

     

    $

    (36,183

    )

    Net loss per share, basic and diluted

     

    $

    (0.71

    )

     

    $

    (0.39

    )

     

    $

    (1.69

    )

     

    $

    (4.67

    )

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

     

     

    26,663,968

     

     

     

    22,907,349

     

     

     

    26,298,969

     

     

     

    7,755,137

     

     

    Karuna Therapeutics, Inc.

    Unaudited Consolidated Balance Sheet Data

    (in thousands)

     

     

    September 30,

    2020

     

     

    December 31,

    2019

     

    Cash, cash equivalents and investments

     

    $

    344,897

     

     

    $

    389,397

     

    Working capital

     

     

    356,101

     

     

     

    389,748

     

    Total assets

     

     

    364,436

     

     

     

    393,024

     

    Total stockholders' equity

     

    $

    357,259

     

     

    $

    389,916

     

     

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  7. Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, today announced that senior management will participate in the following upcoming virtual investor conferences:

    Citi's 15th Annual BioPharma Virtual Conference
    Date: Wednesday, September 9, 2020
    Time: 2:25 p.m. EDT

    Wells Fargo 2020 Virtual Healthcare Conference
    Date: Thursday, September 10, 2020
    Time: 9:20 a.m. EDT

    Morgan Stanley 18th Annual Global Healthcare Conference
    Date: Tuesday, September 15, 2020
    Time: 3:30 p.m. EDT

    A live webcast of the Wells Fargo presentation will be available…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, today announced that senior management will participate in the following upcoming virtual investor conferences:

    Citi's 15th Annual BioPharma Virtual Conference

    Date: Wednesday, September 9, 2020

    Time: 2:25 p.m. EDT

    Wells Fargo 2020 Virtual Healthcare Conference

    Date: Thursday, September 10, 2020

    Time: 9:20 a.m. EDT

    Morgan Stanley 18th Annual Global Healthcare Conference

    Date: Tuesday, September 15, 2020

    Time: 3:30 p.m. EDT

    A live webcast of the Wells Fargo presentation will be available on the Investor Relations page of Karuna's website at investors.karunatx.com. A replay of the webcast will also be archived for up to 90 days on Karuna's website following the conference.

    About Karuna

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

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  8. Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, today announced the appointment of Laurie Olson to its Board of Directors effective August 12, 2020. Ms. Olson will be part of the nominating and corporate governance committee.

    "We are pleased to welcome Laurie to our board at an exciting moment for Karuna as we continue to advance our pipeline and begin the transition to a late-stage biotech company," said Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics. "Laurie's expertise in commercial and corporate…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, today announced the appointment of Laurie Olson to its Board of Directors effective August 12, 2020. Ms. Olson will be part of the nominating and corporate governance committee.

    "We are pleased to welcome Laurie to our board at an exciting moment for Karuna as we continue to advance our pipeline and begin the transition to a late-stage biotech company," said Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics. "Laurie's expertise in commercial and corporate strategy, with a keen focus on identifying and optimizing synergies between R&D and commercial organizations, experience in growing a culture of engaged teams, and advocacy for workplace diversity and inclusion, will be invaluable as we navigate our next phases of growth."

    "Karuna is making tremendous progress in advancing potential new treatments for some of the most serious and complex neuropsychiatric disorders," said Ms. Olson. "I join Karuna at an important inflection point for the company, and look forward to working with management and the board to help grow the organization and capabilities with the goal of delivering meaningful treatment options to patients."

    Ms. Olson is a seasoned pharmaceutical executive with more than 30 years of commercial and corporate strategy experience, most recently serving as the Executive Vice President, Strategy and Commercial Operations at Pfizer Inc. until 2018. In this role, Ms. Olson led a global organization accountable for corporate strategic planning, portfolio management, and commercial support functions. Ms. Olson served as a member of Pfizer's Portfolio Strategy and Investment Committee as well as the Pfizer Board of Directors' Science and Technology Committee, where she was accountable for informing therapeutic area strategies and the utilization of new technologies and analytic methods to drive R&D and commercial productivity. She also was a member of the Business Development, Disclosure, Diversity, and Compliance Committees where she supported Pfizer's commitment to maintaining its transparency and compliance with internal and external stakeholders. Prior to her role as Executive Vice President, Ms. Olson held various positions of increasing authority during her tenure at Pfizer from 1987 to 2018. She currently serves as a member of the Board of Trustees of the Mystic Seaport Museum in Mystic, Connecticut. Ms. Olson received a B.A. in Economics from State University of New York at Stony Brook and an M.B.A. in Marketing from Hofstra University.

    About Karuna

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

    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, 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, 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, 2019 and our Quarterly Report on Form 10-Q for the quarter ended June 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.

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  9.  On track to initiate Phase 3 trials within the EMERGENT program, the clinical program evaluating KarXT for the treatment of acute psychosis in patients with schizophrenia, by the end of 2020

    Topline data from Phase 1b trial in healthy elderly volunteers expected by the end of 2020

    Plans to initiate Phase 2 trial evaluating KarXT as adjunctive therapy with standard of care for the treatment of psychosis in patients with schizophrenia who remain symptomatic on existing therapies

    $367.6 million in cash, cash equivalents and short-term investments expected to fund multiple milestones, including the Phase 3 program to NDA submission, and operations for at least the next three years

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative…

     On track to initiate Phase 3 trials within the EMERGENT program, the clinical program evaluating KarXT for the treatment of acute psychosis in patients with schizophrenia, by the end of 2020

    Topline data from Phase 1b trial in healthy elderly volunteers expected by the end of 2020

    Plans to initiate Phase 2 trial evaluating KarXT as adjunctive therapy with standard of care for the treatment of psychosis in patients with schizophrenia who remain symptomatic on existing therapies

    $367.6 million in cash, cash equivalents and short-term investments expected to fund multiple milestones, including the Phase 3 program to NDA submission, and operations for at least the next three years

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, today announced financial results for the second quarter of 2020 and provided a general business update.

    "We've made tremendous progress in advancing our clinical development programs evaluating KarXT in neuropsychiatric disorders, including schizophrenia and dementia-related psychosis, where the standards of care are simply insufficient," said Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics. "We remain focused on initiating Phase 3 trials within our EMERGENT program following a successful End-of-Phase 2 meeting with the FDA in the second quarter. This important next step brings us closer to providing a new, unique and differentiated treatment option to patients with schizophrenia."

    Dr. Paul continued: "Our commitment to discover and develop more effective treatments for neuropsychiatric disorders is not only underscored by our clinical-stage programs, but also the expansion of our drug discovery efforts. These discovery efforts have enabled us to broaden our approach to CNS drug discovery and development with the goal of enhancing Karuna's pipeline of novel drug candidates for treating a wide range of neuropsychiatric disorders."

    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 (FDA) approved muscarinic antagonist that does not appreciably cross the blood-brain-barrier, to preferentially stimulate muscarinic receptors in the central nervous system (CNS). KarXT is currently being evaluated as a potential treatment for neuropsychiatric disorders, including schizophrenia and dementia-related psychosis.

    • KarXT in schizophrenia: The Company previously announced a positive outcome of its End-of-Phase 2 meeting with the FDA for KarXT for the treatment of acute psychosis in patients with schizophrenia. The outcome of the meeting supports the progression of KarXT into Phase 3 development. The formal minutes from the meeting also confirmed that the completed Phase 2 trial, along with one successful Phase 3 efficacy and safety trial, and additional safety data to meet regulatory requirements, would be acceptable to support a New Drug Application (NDA) filing.
      • The Company is on track to initiate the first Phase 3 trial within its EMERGENT program, the clinical program evaluating KarXT for the treatment of acute psychosis in adults with schizophrenia, by the end of 2020. The EMERGENT program includes the completed positive Phase 2 clinical trial (EMERGENT-1) and additional planned efficacy and safety trials to support an NDA filing, including:
        • EMERGENT-2: A five-week inpatient trial evaluating the efficacy and safety of KarXT in adults with schizophrenia. The EMERGENT-2 trial design shares many characteristics with the completed EMERGENT-1 trial, including duration of treatment, primary endpoint and patient population. EMERGENT-2 is a 1:1 randomized, flexible-dose, double-blind, placebo-controlled trial enrolling approximately 250 adults in the U.S., and will evaluate the change in Positive and Negative Syndrome Scale (PANSS) total score at Week 5 of KarXT versus placebo as the primary outcome measure. EMERGENT-2 is expected to commence by the end of 2020.
        • EMERGENT-3: A five-week inpatient trial evaluating the safety and efficacy of KarXT in adults with schizophrenia. This trial will share characteristics of the completed EMERGENT-1 trial and planned EMERGENT-2 trial, including duration of treatment, patient population and primary outcome measure. Details of the EMERGENT-3 trial will be finalized by the end of 2020, with initiation expected in the first half of 2021.
        • EMERGENT-4: A 52-week, outpatient, open-label long-term safety and tolerability extension trial of EMERGENT-2 and EMERGENT-3.
        • EMERGENT-5: A 52-week, outpatient, open-label long-term trial evaluating the safety of KarXT in adults with schizophrenia who have not been enrolled in the EMERGENT-2 or EMERGENT-3 trials. This trial is expected to commence the first half of 2021.
      • The Company plans to initiate a Phase 2 trial evaluating KarXT as an adjunctive therapy with standard of care for the treatment of psychosis in patients with schizophrenia who remain symptomatic on existing therapies. The Company previously planned to initiate a Phase 1b trial assessing potential Drug-Drug Interactions with a selection of currently marketed antipsychotics in healthy volunteers, but based on multiple considerations, including the evaluation of existing preclinical and clinical data supporting the potential of KarXT to augment traditional antipsychotic drugs, the Company will move forward directly to initiate a Phase 2 trial. 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 had not achieved an adequate response on their current antipsychotic treatment.
        • Data evaluating KarXT as an adjunctive therapy is intended to support a supplemental NDA filing assuming the successful development of KarXT as a monotherapy for the treatment of adults with schizophrenia. The Company plans to initiate this trial following the initiation of the Phase 3 trials within the EMERGENT program.
      • The use of KarXT for the treatment of negative and cognitive symptoms in patients with schizophrenia remains of interest. The Company will collect data on the potential benefit of KarXT on negative and cognitive symptoms of schizophrenia as part of the EMERGENT program and the Company's adjunctive therapy trial. The Company continues to evaluate the timing of potential trial designs specifically directed towards the negative and cognitive symptoms of schizophrenia.
    • KarXT in dementia-related psychosis: The multi-cohort, placebo-controlled, inpatient Phase 1b trial evaluating the safety and tolerability of KarXT in healthy elderly volunteers is ongoing. The trial is designed to demonstrate safety and tolerability of KarXT in healthy elderly volunteers with the goal of selecting the most appropriate dose and dose-titration schedule to carry forward into future studies in patients with dementia-related psychosis.
      • Topline data from the Phase 1b trial is anticipated by the end of 2020. Due to the particular vulnerability of the elderly population to COVID-19, the Company continues to monitor the ongoing COVID-19 pandemic and may elect to pause recruitment in this trial out of an abundance of caution for the health and safety of the elderly volunteers.
    • KarXT in pain: As previously announced, the Company will not move forward to develop KarXT in pain.

    Business Updates

    • The Company recently announced a drug discovery collaboration with PsychoGenics, a phenotypic drug discovery platform company, to identify potential novel drug candidates for the treatment of severe neuropsychiatric disorders. The multi-year drug discovery collaboration leverages behavioral and physiological phenotypic screening and machine learning to identify novel neuropsychiatric treatments. Under the terms of the agreement, Karuna will provide an upfront payment to PsychoGenics for access to its proprietary platforms. Both parties are eligible to receive payments upon reaching pre-specified development, regulatory and commercial milestones, as well as royalties on net sales, for products developed under the agreement.
    • Recruitment of top talent remains a key organizational priority to meet corporate and product development objectives. The Company continues to grow its leadership team with the addition of new strategic hires across functional areas, including Clinical Operations, Regulatory and Commercial.

    Second Quarter 2020 Financial Results

    The Company reported a net loss of $17.0 million for the second quarter of 2020, as compared to $15.1 million for the prior year period. The increase in net loss for the period was due to higher research and development expenses related to preparation for the initiation of the Company's Phase 3 clinical trials within its EMERGENT program but was partially offset by lower general and administrative stock compensation expense.

    Research and development expenses were $10.8 million for the second quarter of 2020, as compared to $6.8 million for the prior year period. The increase in research and development expenses for the period was primarily driven by expenses related to the preparation for the initiation of the Company's Phase 3 clinical trials within its EMERGENT program, including CRO start-up costs and clinical trial material manufacturing. In addition, the Company had additional expenses related to its Phase 1b trials in healthy elderly volunteers and experimentally induced pain, increased personnel-related costs due to the increase in employee headcount, as well as expenses associated with consulting fees and the Company's discovery programs.

    General and administrative expenses were $7.0 million for the second quarter of 2020, as compared to $8.3 million for the prior year period. The decrease in general and administrative expenses was primarily due to the acceleration of option awards as a result of the Company's IPO and was partially offset by increased expenses related to increased employee headcount and higher costs related to the support of business operations as a publicly traded company.

    The Company ended the quarter with $367.6 million in cash, cash equivalents, and short-term investments compared to $389.4 million as of December 31, 2019. The Company expects that its current cash, cash equivalents, and short-term investments as of June 30, 2020 will enable the Company to fund its operating expenses and capital expenditure requirements for at least the next three years. 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 clinical trials. Additional activities which may be funded include the completion of the Phase 1b and potential Phase 2 trial for the treatment of dementia-related psychosis and continued investment into pipeline expansion, including evaluating KarXT as an adjunctive therapy in patients with schizophrenia.

    About Karuna

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

    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 our cash resources, the timing of advancing of our planned clinical trials and regulatory filings, interim trial results, our goals to develop and commercialize our product candidates, our identification of additional 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, 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, 2019 and our Quarterly Report on Form 10-Q for the quarter ended June 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.

     

    Karuna Therapeutics, Inc.

    Unaudited Consolidated Statements of Operations

    (in thousands, except share and per share data)

     

     

     

    Three Months Ended

    June 30,

     

     

    Six Months Ended

    June 30,

     

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenue

     

     

     

     

     

     

     

     

     

     

     

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    10,819

     

     

    $

    6,784

     

     

    $

    15,239

     

     

    $

    13,751

     

    General and administrative

     

     

    7,006

     

     

     

    8,286

     

     

     

    12,641

     

     

     

    12,892

     

    Total operating expenses

     

     

    17,825

     

     

     

    15,070

     

     

     

    27,880

     

     

     

    26,643

     

    Loss from operations

     

     

    (17,825

    )

     

     

    (15,070

    )

     

     

    (27,880

    )

     

     

    (26,643

    )

    Other income (expense):

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Interest income

     

     

    779

     

     

     

    452

     

     

     

    2,176

     

     

     

    567

     

    Interest income, net

     

     

     

     

     

     

     

     

     

     

     

    11

     

    Accretion of debt discount

     

     

     

     

     

    (522

    )

     

     

     

     

     

    (945

    )

    Change in fair value of derivative

     

     

     

     

     

     

     

     

     

     

     

    (135

    )

    Total other income (expense), net

     

     

    779

     

     

     

    (70

    )

     

     

    2,176

     

     

     

    (502

    )

    Net loss before income taxes

     

     

    (17,046

    )

     

     

    (15,140

    )

     

     

    (25,704

    )

     

     

    (27,145

    )

    Income tax provision

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss attributable to common stockholders

     

    $

    (17,046

    )

     

    $

    (15,140

    )

     

    $

    (25,704

    )

     

    $

    (27,145

    )

    Net loss per share, basic and diluted

     

    $

    (0.65

    )

     

    $

    (146.02

    )

     

    $

    (0.98

    )

     

    $

    (507.76

    )

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

     

     

    26,186,493

     

     

     

    103,684

     

     

     

    26,114,464

     

     

     

    53,460

     

    Karuna Therapeutics, Inc.

    Unaudited Consolidated Balance Sheet Data

    (in thousands)

     

     

     

    June 30,

    2020

     

     

    December 31,

    2019

     

    Cash, cash equivalents and short-term investments

     

    $

    367,585

     

     

    $

    389,397

     

    Working capital

     

     

    370,787

     

     

     

    389,748

     

    Total assets

     

     

    377,816

     

     

     

    393,024

     

    Total stockholders' equity

     

    $

    371,803

     

     

    $

    389,916

     

     

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  10. Topline results of exploratory trial do not provide conclusive evidence of an analgesic benefit of KarXT on experimentally induced pain in healthy volunteers

    The Company will not move forward to evaluate KarXT for the treatment of pain

    The safety and tolerability profile of KarXT was consistent with previous trials

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, today announced results from KAR-020, its Phase 1b trial evaluating the analgesic effects of KarXT on experimentally induced pain in healthy volunteers. Topline results of this…

    Topline results of exploratory trial do not provide conclusive evidence of an analgesic benefit of KarXT on experimentally induced pain in healthy volunteers

    The Company will not move forward to evaluate KarXT for the treatment of pain

    The safety and tolerability profile of KarXT was consistent with previous trials

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, today announced results from KAR-020, its Phase 1b trial evaluating the analgesic effects of KarXT on experimentally induced pain in healthy volunteers. Topline results of this exploratory trial were inconclusive and do not provide sufficient evidence of an analgesic benefit of KarXT compared to placebo. The Company will not move forward to develop KarXT in pain.

    The KAR-020 trial employed an intra-individual cross-over design to evaluate objective and subjective pain measurements of KarXT and placebo in three different skin conditions meant to model nociceptive (normal skin), inflammatory (UVB-irradiated skin) and neuropathic (capsaicin-treated skin) pain in 24 healthy volunteers. The safety and tolerability profile of KarXT was consistent with previous clinical trials of KarXT. There were no serious adverse events observed in the trial, and no clinically meaningful changes in vital signs or clinical laboratory values.

    "Today's results do not provide compelling evidence of the analgesic benefit observed in preclinical trials," said Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics. "While this data does not support the continued development of KarXT in pain, we will continue to evaluate data from this trial to better assess the potential role of muscarinic-targeted receptor treatments in pain management."

    Dr. Paul continued: "Looking ahead, we remain focused on developing KarXT for the treatment of severe neuropsychiatric disorders, including schizophrenia and dementia-related psychosis, where robust evidence from previous clinical trials supports the potential of KarXT to provide a new, unique and mechanistically differentiated therapeutic for the treatment of these disorders. We remain on track to initiate Phase 3 development in schizophrenia later this year."

    About KarXT

    KarXT, a proprietary oral modulator of muscarinic cholinergic receptors, is Karuna's lead product candidate that 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 (CNS). 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. KarXT is currently being evaluated in clinical development as a potential treatment for serious neuropsychiatric disorders, including schizophrenia and dementia-related psychosis.

    About Karuna

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

    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 the timing of advancing of our planned clinical trials and regulatory filings, interim trial results, 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 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, 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, 2019. 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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  11. Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced that senior management will participate in the following upcoming virtual investor conferences:

    William Blair's Biotech Focus Conference
    Date: Thursday, August 6, 2020
    Time: 10:00 a.m. EDT

    Wedbush PacGrow Healthcare Virtual Conference
    Date: Tuesday, August 11, 2020
    Time: 10:55 a.m. EDT

    Canaccord Genuity 40th Annual Growth Conference
    Date: Wednesday, August 12, 2020
    Time: 4:00 p.m. EDT

    JMP Securities CNS Forum
    Date: Wednesday, August 19, 2020
    Time: 11:30 a.m. EDT…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced that senior management will participate in the following upcoming virtual investor conferences:

    William Blair's Biotech Focus Conference

    Date: Thursday, August 6, 2020

    Time: 10:00 a.m. EDT

    Wedbush PacGrow Healthcare Virtual Conference

    Date: Tuesday, August 11, 2020

    Time: 10:55 a.m. EDT

    Canaccord Genuity 40th Annual Growth Conference

    Date: Wednesday, August 12, 2020

    Time: 4:00 p.m. EDT

    JMP Securities CNS Forum

    Date: Wednesday, August 19, 2020

    Time: 11:30 a.m. EDT

    A live webcast of the Wedbush presentation will be available on the Investor Relations page of Karuna's website at investors.karunatx.com. A replay of the webcast will also be archived for up to 90 days on Karuna's website following the conference.

    About Karuna

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

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  12. Multi-year drug discovery collaboration leveraging behavioral and physiological phenotypic screening and machine learning to identify novel neuropsychiatric drug candidates

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, and PGI Drug Discovery LLC (PsychoGenics), a phenotypic drug discovery platform company, today announced that the companies have entered a multi-year drug discovery and development agreement to identify potential novel drug candidates for the treatment of severe neuropsychiatric disorders.

    This press release features…

    Multi-year drug discovery collaboration leveraging behavioral and physiological phenotypic screening and machine learning to identify novel neuropsychiatric drug candidates

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, and PGI Drug Discovery LLC (PsychoGenics), a phenotypic drug discovery platform company, today announced that the companies have entered a multi-year drug discovery and development agreement to identify potential novel drug candidates for the treatment of severe neuropsychiatric disorders.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200728005227/en/

    Under the terms of the agreement, Karuna will provide an upfront payment to PsychoGenics for access to its proprietary screening platforms, which leverage computer vision and machine learning, to discover novel neuropsychiatric treatments. Each party is eligible to receive payments upon reaching pre-specified development, regulatory and commercial milestones, as well as royalties on net sales, for products developed under the agreement.

    "PsychoGenics is a leader in preclinical behavioral neurobiology with a successful track record of identifying novel drug candidates for the treatment of serious and complex neuropsychiatric disorders via its proprietary target-agnostic machine learning approach," said Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics. "We look forward to leveraging our collective expertise in neuroscience and CNS drug discovery to identify and evaluate new drug candidates to further enhance and complement our pipeline of differentiated target-directed neuropsychiatric drugs, including KarXT, our lead candidate in development for the treatment of schizophrenia and dementia-related psychosis."

    "Karuna's established leadership team and demonstrated success in neuropsychiatric drug discovery and development has put them at the forefront of leading the next new generation of neuropsychiatric treatments," said Emer Leahy, Ph.D., chief executive officer and president of PsychoGenics. "Together we share a common vision of discovering novel drug candidates to treat neuropsychiatric disorders. The collaboration with Karuna enables us to continue to contribute to leading discoveries in the field of neuroscience."

    About Karuna

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

    About PsychoGenics Inc. and PGI Drug Discovery LLC

    PsychoGenics Inc. and its discovery arm PGI Drug Discovery LLC (collectively known as PsychoGenics) have pioneered the translation of rodent behavioral and physiological responses into robust, high-throughput and high-content phenotyping. PsychoGenics' drug discovery platforms, SmartCube®, NeuroCube®,PhenoCube®, and eCubeTM have been used in shared-risk partnerships with major pharma companies including Sunovion and Roche, resulting in the discovery of several novel compounds now in clinical trials or advanced preclinical development. PsychoGenics' capabilities also include standard behavioral testing, electrophysiology, translational EEG, molecular biology, microdialysis and quantitative immunohistochemistry. In addition, the company offers a variety of in-licensed transgenic mouse models that support research in areas such as Huntington's disease, autism spectrum disorders, psychosis/schizophrenia, depression, PTSD, Alzheimer's disease, Parkinson's disease, muscular dystrophy, ALS, seizure disorders and pain. For more information on PsychoGenics Inc., visit www.psychogenics.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 identification of additional product candidates, the initiation and advancement of our clinical trials and regulatory filings, our goals to develop and commercialize 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, 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, 2019. 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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  13. One additional Phase 3 trial, along with previously completed Phase 2 trial, would be acceptable to support an efficacy claim for a New Drug Application filing

    Company on track to initiate Phase 3 program, including efficacy and open-label long-term safety trials, by the end of 2020

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced next steps in the clinical program evaluating KarXT for the treatment of acute psychosis in patients with schizophrenia following the completion of a successful End-of-Phase 2 meeting…

    One additional Phase 3 trial, along with previously completed Phase 2 trial, would be acceptable to support an efficacy claim for a New Drug Application filing

    Company on track to initiate Phase 3 program, including efficacy and open-label long-term safety trials, by the end of 2020

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced next steps in the clinical program evaluating KarXT for the treatment of acute psychosis in patients with schizophrenia following the completion of a successful End-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA). The outcome of the meeting supports the progression of KarXT into Phase 3 development. The Company remains on track to initiate the Phase 3 program by the end of 2020.

    "We look forward to progressing KarXT into Phase 3 clinical development for the treatment of schizophrenia following a constructive End-of-Phase 2 meeting with the FDA," said Andrew Miller, Ph.D., chief operating officer and founder of Karuna Therapeutics. "Our team is dedicated to truly advancing the standard of care in schizophrenia, and we believe our planned Phase 3 program sets us on course to potentially offer a new, unique and mechanistically differentiated treatment option relative to current therapies. We are pleased to be working closely with the FDA as we prepare to advance our lead clinical program into Phase 3 by the end of the year."

    The End-of-Phase 2 discussion was supported by pre-clinical and clinical efficacy data, including results from the previously completed positive Phase 2 trial evaluating KarXT in patients with schizophrenia. In the Phase 2 trial, KarXT demonstrated robust efficacy on primary and key secondary outcome measures and was generally safe and well tolerated.

    The Company and FDA aligned on key elements of the Phase 3 program to support a New Drug Application (NDA) filing, including the initiation of additional trials evaluating the efficacy and long-term safety of KarXT. The formal minutes from the meeting confirmed that the completed Phase 2 trial, along with one successful Phase 3 efficacy and safety trial, and additional safety data to meet regulatory requirements, would be acceptable to support an NDA filing.

    The Company plans to initiate two five-week inpatient trials evaluating the efficacy and safety of KarXT for the treatment of acute psychosis in adults with schizophrenia. Both trials will share key characteristics of the completed Phase 2 trial, such as duration of treatment, patient population and primary outcome measure, among other aspects. The first Phase 3 trial is expected to commence by the end of 2020. This five-week, 1:1 randomized, flexible-dose, double-blind, placebo-controlled, inpatient trial will enroll approximately 250 adults in the U.S. and evaluate the change in Positive and Negative Syndrome Scale total score at Week 5 of KarXT versus placebo as the primary outcome measure. Details of the second efficacy trial will be finalized by the end of 2020, with initiation expected in the first half of 2021.

    In conjunction with the short-term efficacy and safety trials, the Company will collect long-term, open-label data to assess the safety and tolerability of KarXT in patients for up to one year in an outpatient setting. Following the five-week, double-blind, inpatient phase in both efficacy trials, patients may enter a 52-week open-label safety and tolerability extension in which all patients will receive active treatment. The Company currently plans to also conduct a separate 52-week open-label trial evaluating the long-term safety of KarXT in adults with schizophrenia who have not been enrolled in the inpatient trials. This trial is expected to begin the first half of 2021. Data from these trials will be used to support regulatory safety requirements for an NDA filing.

    As previously shared, the Company is well capitalized, with sufficient funding to support development activities for the NDA filing. Additional details regarding the development plan, including anticipated completion timelines, will be shared in the second half of 2020.

    About KarXT

    KarXT, a proprietary oral modulator of muscarinic cholinergic receptors, is Karuna's lead product candidate that 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 (CNS). 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, disabling disorder typically diagnosed in late teenage years or early adulthood. Characterized by recurring episodes of psychosis requiring long-term treatment with antipsychotic drugs in most patients, it affects more than 21 million people worldwide and 2.7 million Americans (0.5% - 1.0% of U.S. population).

    At least one-third of patients with schizophrenia fail to respond to current treatments, with 74% of patients discontinuing within 18 months of initiation. People with schizophrenia have a 10- to 15-year reduction in life expectancy and struggle to maintain meaningful interpersonal relationships. The World Health Organization ranks psychosis as the third-most disabling medical condition in the world.

    About Karuna

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

    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 our cash resources, the timing of advancing of our planned clinical trials and regulatory filings, interim trial results, 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, 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, 2019. 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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  14. Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced that Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics, will participate in a fireside chat at the virtual Goldman Sachs Annual Global Healthcare Conference on Thursday, June 11, 2020 at 10:30 a.m. EDT.

    A live webcast of the fireside chat will be available on the Investor Relations page of Karuna's website at investors.karunatx.com. A replay of the webcast will also be archived for up to 90 days on Karuna's website following the…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced that Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics, will participate in a fireside chat at the virtual Goldman Sachs Annual Global Healthcare Conference on Thursday, June 11, 2020 at 10:30 a.m. EDT.

    A live webcast of the fireside chat will be available on the Investor Relations page of Karuna's website at investors.karunatx.com. A replay of the webcast will also be archived for up to 90 days on Karuna's website following the conference.

    About Karuna

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

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    • End of Phase 2 meeting scheduled with the U.S. Food and Drug Administration (FDA) with feedback from the meeting expected to be announced in the second quarter
    • Additional data from Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia to be presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting
    • CNS pipeline programs in pain and healthy elderly volunteers remain on track
    • $383.5 million in cash, cash equivalents and short-term investments, funding operations for at least the next three years
    • Appointed Christopher J. Coughlin to the board of directors and as chair of the audit committee

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage…

    • End of Phase 2 meeting scheduled with the U.S. Food and Drug Administration (FDA) with feedback from the meeting expected to be announced in the second quarter
    • Additional data from Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia to be presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting
    • CNS pipeline programs in pain and healthy elderly volunteers remain on track
    • $383.5 million in cash, cash equivalents and short-term investments, funding operations for at least the next three years
    • Appointed Christopher J. Coughlin to the board of directors and as chair of the audit committee

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced financial results for the first quarter of 2020 and provided a general business update.

    "We are off to a strong start in 2020 and continue to make significant progress advancing our lead program, KarXT for the treatment of acute psychosis in patients with schizophrenia," stated Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics. "On the heels of completing a Phase 2 clinical trial that demonstrated statistically significant and clinically meaningful efficacy and tolerability, we look forward to sharing the outcome from our upcoming end of Phase 2 meeting with the FDA in the second quarter. We plan to highlight KarXT's potential best-in-class clinical profile by presenting additional data at the ASCP Annual Meeting. We are also excited to welcome Chris Coughlin to our board of directors."

    Dr. Paul continued: "The COVID-19 global pandemic has dramatically changed the landscape for biotech companies and has, in many cases, impacted timelines. Karuna has adopted all recommendations in line with guidance from health authorities to protect the safety of our employees and our community. Like so many other companies, we have implemented work-from-home policies and restricted on-site activities when possible. At this point, we remain confident in our ability to deliver upon all stated timelines. Given the dynamic nature of the situation, we will continue to regularly monitor and assess the possible impact of the pandemic on our business and look forward to providing updates over the course of this year."

    Business Highlights

    • KarXT for schizophrenia. KarXT, a proprietary oral modulator of muscarinic cholinergic receptors, is the Company's lead product candidate that 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 (CNS). 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.
      • KarXT Phase 2 data highlighting details of efficacy, tolerability and safety will be presented at the ASCP Annual Meeting scheduled for the end of May. The presentation will include both efficacy and safety data, including the relative rates (versus placebo) and time-course of treatment emergent adverse events.
      • End of Phase 2 meeting with the FDA has been scheduled and is expected to be held virtually; the Company plans to provide feedback from the meeting in the second quarter.
      • On track to initiate Phase 3 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia in 2020. Subject to the outcome of the upcoming end of Phase 2 meeting with the FDA, the Company expects to initiate its Phase 3 clinical trial by the end of 2020.
      • Currently evaluating the KarXT development strategy for use as adjunctive therapy in patients with persistent negative and cognitive symptoms and those with inadequate response to their current antipsychotic therapy. Based on clinical and preclinical data supporting the potential of KarXT to augment traditional antipsychotic drugs, the Company intends to pursue clinical trials to determine the safety and efficacy of KarXT when dosed in conjunction with background antipsychotics to improve negative and cognitive symptoms, and to further improve positive symptoms in patients who remain symptomatic on existing therapies. There are no FDA approved therapies for these indications. The Company had previously planned to initiate a Phase 1b study to assess potential Drug-Drug Interactions (DDI) with a selection of currently marketed antipsychotics in healthy volunteers in order to enable the initiation of Phase 2 adjunctive therapy trials. However, the Company is reevaluating the need to conduct a Phase 1b DDI study and will provide further guidance by mid-year on its strategy and timeline to enter Phase 2 trials.
    • CNS pipeline. The Company's clinical development pipeline is built on the therapeutic potential of KarXT and the established link between the stimulation of muscarinic receptors in the CNS and its ability to beneficially impact a wide range of disorders including schizophrenia, dementia-related psychosis and various forms of pain.
      • Data from Phase 1b clinical trial of KarXT in healthy elderly volunteers expected by the end of 2020. In December 2019, the Company initiated a Phase 1b clinical trial of KarXT designed to demonstrate safety and tolerability in healthy elderly volunteers, with the goal of selecting the most appropriate doses to carry forward into future studies in patients with dementia-related psychosis. The multi-cohort, placebo-controlled, two-week Phase 1b trial utilizes a 3:1 randomization of KarXT to placebo.
      • Dosing completed for Phase 1b clinical trial of KarXT in experimentally induced pain; data expected in mid-2020. Preclinical data published in peer-reviewed scientific journals link the stimulation of xanomeline to analgesic benefits. Xanomeline in particular has demonstrated robust non-opioid analgesic activity in several animal models of pain, including post-operative, inflammatory and neuropathic pain. Based on these data, the Company has recently completed enrollment of a Phase 1b clinical trial of KarXT in experimentally induced pain in healthy volunteers. The results of this trial are expected to help guide the prioritization of pain conditions for potential clinical trials of KarXT in the future.
      • Expansion of organizational capacity to support KarXT product development and regulatory objectives. Karuna continues to grow its leadership team with the addition of new strategic hires across multiple functional areas including Clinical Operations, Medical, Human Resources and Legal. Recruitment of top talent remains a key organizational priority as the Company expands its capacity to meet KarXT development objectives in 2020.
    • Christopher J. Coughlin appointed to Karuna's board of directors. In April 2020, Karuna appointed Christopher J. Coughlin to the board of directors and named him chair of the audit committee. He previously served as advisor to the chairman and CEO of Tyco International Ltd., a global provider of diversified products, services and industries, and as executive vice president and chief financial officer of Tyco during a period of significant international growth and restructuring. Mr. Coughlin currently serves on the boards of Allergan plc, Alexion Pharmaceuticals, Inc. and Prestige Consumer Healthcare Inc. He previously served on the boards of The Dun & Bradstreet Corp, Hologic, Inc., Covidien Ltd, Dipexium Pharmaceuticals, Inc., Forest Laboratories, Inc., Interpublic Group of Companies, Monsanto Company and Perrigo Company.
    • Cash and cash equivalents of $383.5 million sufficient to fund operations for at least the next three years and achieve multiple data catalysts. Current funding is sufficient to fund all development activities leading to the filing of a New Drug Application with the FDA for the treatment of psychosis in schizophrenia, including two Phase 3 clinical efficacy studies and a required long-term safety study. Additional activities funded include the completion of Phase 1b and 2 trials for the treatment of dementia-related psychosis, completion of Phase 1b and 2 trials for the treatment of pain, and continued investment into pipeline expansion.

    First Quarter 2020 Financial Results

    The Company reported a net loss of $8.7 million for the first quarter of 2020, as compared to $12.0 million for the prior year period. The decrease in net loss for the period was due to phasing of research and development expenses related to our schizophrenia program as well as higher interest income generated from our cash equivalents and short-term investments.

    Research and development expenses were $4.4 million for the first quarter of 2020, as compared to $7.0 million for the prior year period. The decrease in research and development expenses for the period was primarily driven by unrepeated spending related to the Company's Phase 2 clinical trial for the treatment of schizophrenia, which was completed in 2019. This decrease was partially offset by additional expenses related to Phase 1b trials in healthy elderly volunteers and experimentally induced pain, increased personnel-related costs due to the increase in employee headcount, as well as expenses associated with consulting fees and our discovery programs.

    General and administrative expenses were $5.6 million for the first quarter of 2020, as compared to $4.6 million for the prior year period. The increase in general and administrative expenses primarily resulted from an increase in employee headcount and higher costs related to the support of business operations as a publicly traded company.

    The Company ended the quarter with $383.5 million in cash, cash equivalents, and short-term investments compared to $389.4 million as of December 31, 2019. The Company expects that current cash, cash equivalents, and short-term investments as of March 31, 2020, will enable the Company to fund its operating expenses and capital expenditure requirements for at least the next three years. 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 clinical trials.

    About Karuna

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

    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 our cash resources, the timing of advancing of our planned clinical trials and regulatory filings, interim trial results, 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, 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, 2019. 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,

     

     

    2020

     

    2019

     

    Revenue

     

     

     

     

    Operating expenses:

     

     

     

     

     

     

    Research and development

    $

    4,420

     

    $

    6,967

     

    General and administrative

     

    5,635

     

     

    4,606

     

    Total operating expenses

     

    10,055

     

     

    11,573

     

    Loss from operations

     

    (10,055

    )

     

    (11,573

    )

    Other income (expense):

     

     

     

     

     

     

    Interest income

     

    1,397

     

     

    115

     

    Interest income, net

     

     

     

    11

     

    Accretion of debt discount

     

     

     

    (423

    )

    Change in fair value of derivative

     

     

     

    (135

    )

    Total other income (expense), net

     

    1,397

     

     

    (432

    )

    Net loss before income taxes

     

    (8,658

    )

     

    (12,005

    )

    Income tax provision

     

     

     

     

    Net loss attributable to common stockholders

    $

    (8,658

    )

    $

    (12,005

    )

    Net loss per share, basic and diluted

    $

    (0.33

    )

    $

    (4,484

    )

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

     

    26,042,434

     

     

    2,677

     

    Karuna Therapeutics, Inc.

    Unaudited Consolidated Balance Sheet Data

    (in thousands)

     

     

     

    March 31,

    2020

     

     

    December 31,

    2019

     

    Cash, cash equivalents and short-term investments

     

    $

    383,491

     

     

    $

    389,397

     

    Working capital

     

     

    384,016

     

     

     

    389,748

     

    Total assets

     

     

    389,718

     

     

     

    393,024

     

    Total stockholders' equity

     

    $

    384,941

     

     

    $

    389,916

     

     

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  15. Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced the appointment of Christopher J. Coughlin to its board of directors. Mr. Coughlin will chair Karuna's audit committee.

    "We are thrilled to have Chris join our board," stated Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics. "Chris brings a broad range of experience in leading and advising companies of all sizes, including a number of successful pharmaceutical and biotechnology companies. His more than 25 years of experience and expertise…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced the appointment of Christopher J. Coughlin to its board of directors. Mr. Coughlin will chair Karuna's audit committee.

    "We are thrilled to have Chris join our board," stated Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics. "Chris brings a broad range of experience in leading and advising companies of all sizes, including a number of successful pharmaceutical and biotechnology companies. His more than 25 years of experience and expertise in strategic financial transactions, acquisitions and divestures, and his strong accounting background will significantly add to the breadth of our current board as Karuna continues to progress and grow as a public company."

    "Karuna is doing remarkable work and its lead product has the potential to dramatically change the CNS treatment landscape," stated Chris Coughlin. "Over the course of my career, I have had the opportunity to be a part of a number of companies and am excited to be joining Karuna's board at this pivotal point as the company scales to meet its goal of delivering transformational therapies to patients. I look forward to working alongside other members of the board and company management to achieve better patient outcomes."

    Mr. Coughlin has served as a senior financial and operating executive at a number of global public companies and has served on the board of directors for many others. Most recently, he was executive vice president and chief financial officer of Tyco International Ltd., a global industrial and healthcare company. Prior to joining Tyco, Mr. Coughlin served as chief operating officer at Interpublic Group, a leading global advertising and market services holding company, as chief financial officer of Pharmacia Corporation, a major pharmaceutical company acquired by Pfizer, and as president of Nabisco International.

    Mr. Coughlin is currently the lead independent director of Allergan plc, and chairs the audit and finance committee for Alexion Pharmaceuticals. He previously served on the board of directors of Dun & Bradstreet, Inc., where he was chairman; Hologic, Inc.; Forest Laboratories (acquired by Allergan plc); Covidien plc (acquired by Medtronic plc); Dipexium Pharmaceuticals Inc.; The Interpublic Group of Companies; Monsanto Company; and Perrigo Company. Mr. Coughlin was named NACD 2015 Corporate Director of the Year.

    Mr. Coughlin holds a bachelor's degree in accounting from Boston College.

    About Karuna

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

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  16. Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced that Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics will participate in a panel presentation at Stifel's 2nd Annual CNS Day Virtual Event on Wednesday, April 1, 2020.

    About Karuna

    Karuna is a clinical-stage biopharmaceutical company committed to developing and delivering first-in-class therapies with the potential to transform the lives of people with CNS disorders – which remain among the most disabling and potentially fatal disorders…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced that Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics will participate in a panel presentation at Stifel's 2nd Annual CNS Day Virtual Event on Wednesday, April 1, 2020.

    About Karuna

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

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    • Met primary endpoint in Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia and demonstrated favorable safety profile with no significant weight gain, somnolence or extrapyramidal side effects relative to placebo
    • Met secondary endpoints on both PANSS positive and negative symptom subscales, PANSS Marder factor and CGI-S
    • Raised more than $430 million in gross proceeds during 2019, funding operations for at least the next three years
    • Initiated a Phase 1b clinical trial to evaluate the safety and tolerability of KarXT in healthy elderly volunteers in order to select the most appropriate doses to study KarXT in dementia-related psychosis patients, with data expected in the second half of 2020
    • Met primary endpoint in Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia and demonstrated favorable safety profile with no significant weight gain, somnolence or extrapyramidal side effects relative to placebo
    • Met secondary endpoints on both PANSS positive and negative symptom subscales, PANSS Marder factor and CGI-S
    • Raised more than $430 million in gross proceeds during 2019, funding operations for at least the next three years
    • Initiated a Phase 1b clinical trial to evaluate the safety and tolerability of KarXT in healthy elderly volunteers in order to select the most appropriate doses to study KarXT in dementia-related psychosis patients, with data expected in the second half of 2020
    • Initiated a Phase 1b clinical trial of experimentally induced pain in healthy volunteers, with data expected mid-2020
    • Expanded discovery research efforts through collaboration with Charles River

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), an innovative clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced financial results for the fourth quarter and year ended 2019 and provided a general business update.

    "2019 has been a transformational year for Karuna. Following our initial public offering in June, we were pleased to announce that the Phase 2 data from our lead program, KarXT, in acute psychosis in patients with schizophrenia demonstrated a highly significant and clinically meaningful reduction in total Positive and Negative Syndrome Scale (PANSS) scores when compared to placebo, the trial's primary efficacy endpoint, while demonstrating overall good tolerability – importantly, KarXT treatment was not associated with the undesirable adverse events commonly observed with currently marketed antipsychotics, namely weight gain, sedation, or extrapyramidal symptoms," stated Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics. "In addition to completing our pivotal Phase 2 trial in schizophrenia, we initiated a Phase 1b trial of KarXT to evaluate its safety and tolerability in healthy elderly volunteers, in order to select the most appropriate doses to study KarXT's efficacy and safety in dementia related psychosis. In addition, we initiated a second Phase 1b trial to assess KarXT's analgesic effect on experimentally induced pain in healthy volunteers. Our momentum in 2019 carried over into 2020 as we increased our R&D efforts to expand our early pipeline to move forward as a multi-program CNS research and clinical development-focused company that is well funded for at least the next three years."

    2019 Business Highlights

    • KarXT for the treatment of acute psychosis in patients with schizophrenia. KarXT, a proprietary oral modulator of muscarinic cholinergic receptors, is the Company's lead product candidate that 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 (CNS). This novel product candidate has the potential to create a new class of antipsychotic drug and produce a differentiated therapy relative to current D2 dopamine and serotonin receptor-based antipsychotic drugs that could dramatically impact patients with schizophrenia and other psychotic disorders, if approved.
    • KarXT met primary and multiple secondary endpoints in Phase 2 clinical trial. In November 2019, the Company announced results of its Phase 2 trial that demonstrated a statistically significant and clinically meaningful 11.6 point mean reduction in total Positive and Negative Syndrome Scale (PANSS) score, the trial's primary efficacy endpoint, when compared to placebo (p<0.0001). The Company has also confirmed that KarXT achieved statistical significance (p<0.001) in the first four of the trial's secondary endpoints (PANSS-Positive, CGI-S, PANSS-Negative and PANSS Marder Factor scores). The Company reported a 4:1 ratio of CGI-S responders between KarXT and placebo, which was the fifth prespecified secondary endpoint (p=0.151). KarXT was well tolerated in the Phase 2 trial, with similar discontinuation rates between KarXT (20%) and placebo (21%). The number of discontinuations due to treatment emergent adverse events (AEs) were equal in the KarXT and placebo arms (n=2 in each group). Notably, in the study KarXT did not result in adverse events commonly associated with currently marketed antipsychotics including weight gain, sedation, or extrapyramidal symptoms.
    • On track to initiate Phase 3 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia in 2020. The Company is completing final analysis of the Phase 2 data and expects to announce additional details of safety and tolerability at upcoming medical meetings and in a peer-reviewed publication. The Company anticipates holding an end-of-Phase 2 meeting with the FDA in Q2 2020. Based on the outcome of this meeting, the Company expects to initiate its Phase 3 clinical trial by the end of 2020.
    • Advanced CNS pipeline in 2019. The Company's pipeline is built on the therapeutic potential of KarXT and the established link between stimulation of muscarinic receptors in the CNS and its ability to beneficially impact a wide range of disorders including schizophrenia, dementia-related psychosis and various forms of pain.
    • Data from Phase 1b clinical trial of KarXT in healthy elderly volunteers expected by the end of 2020. In December 2019, the Company initiated a Phase 1b clinical trial of KarXT designed to demonstrate the safety and tolerability of KarXT in healthy elderly volunteers with the goal of selecting the most appropriate doses to carry forward into future studies in patients with dementia-related psychosis. The placebo-controlled two-week Phase 1 trial utilizes a 3:1 randomization of KarXT to placebo respectively. Top line data from this trial are expected by the end of 2020.
    • Data from the Phase 1b clinical trial of KarXT in experimentally induced pain expected in mid-2020. Preclinical data published in peer-reviewed scientific journals link the stimulation of muscarinic receptors, and specifically xanomeline, to analgesic benefits. Xanomeline has demonstrated robust non-opioid analgesic activity in several animal models of different types of pain including post-operative, inflammatory and neuropathic pain. Based on these data, the Company has initiated a Phase 1b clinical trial of KarXT in experimentally induced pain in healthy volunteers with the goal of translating the preclinical analgesic effects to human to help guide the prioritization of pain conditions for potential future Phase 2 clinical trials. Data from this trial are expected by mid-2020.
    • Expanded discovery research efforts in CNS. In February 2020, the Company announced a new multi-year drug discovery collaboration with Charles River, a leading early-stage contract research organization. In addition, the Company announced the opening of a new office in Indianapolis to support continued growth in its drug discovery efforts and further build a pipeline of product candidates that target key neurotransmitter receptors to treat a broad range of CNS disorders.
    • Completed successful Series B financing, initial public offering, and follow-on offering funding operations for at least the next three years. In November 2019, the Company raised net proceeds of approximately $234 million from its follow-on public offering. The November follow-on offering adds to the strong fundraising year in which the Company raised $75 million in net proceeds from its Series B financing and $93 million in net proceeds from its initial public offering.

    Fourth Quarter and Year End 2019 Financial Results

    The Company reported a net loss of $7.8 million for the fourth quarter 2019, and a net loss of $44.0 million for the year ended 2019, as compared to $8.3 million and $17.5 million for the prior year periods. The increase in net loss for the year was due to increased research and development expenses, increased personnel expenses as a result of an increase in employee headcount, as well as an increase in general and administrative expenses primarily related to investments in the Company's infrastructure as a publicly traded company.

    Research and development expenses were $5.0 million for the fourth quarter 2019, and $24.5 million for the year ended 2019, as compared to $6.7 million and $11.5 million for the prior year periods, respectively. The increase in research and development expenses for the year was primarily driven by increased spending related to the Company's Phase 2 clinical trial for the treatment of schizophrenia, Phase 1b trials in healthy elderly volunteers and experimentally induced pain, increased personnel-related costs due to the increase in employee headcount, as well as expenses associated with consulting fees and our discovery programs.

    General and administrative expenses were $3.9 million for the fourth quarter 2019, and $20.9 million for the year ended 2019, as compared to $1.4 million and $3.0 million for the prior year periods, respectively. The increase in general and administrative expenses was primarily due to an increase in employee headcount inclusive of the impact of stock-based compensation and higher costs related to the support of business operations as a publicly traded company.

    The Company ended the year with $389.4 million in cash, cash equivalents and short-term investments compared to $13.9 million as of December 31, 2018. The increase was primarily the result of the completion of the Company's follow-on public offering which generated $234.2 million in net proceeds, the completion of the initial public offering which generated $93.0 million in net proceeds, and Series B Preferred Stock Financing which generated net proceeds of $74.8 million. The Company expects that current cash, cash equivalents, and short-term investments as of December 31, 2019, will enable the Company to fund its operating expenses and capital expenditure requirements for at least the next three years. This includes multiple potential clinical and development milestones, including an NDA submission of KarXT in psychosis related to schizophrenia, pending the outcomes of the Company's planned clinical trials.

    About Karuna

    Karuna is an innovative clinical-stage biopharmaceutical company primarily focused on developing novel therapies to address disabling neuropsychiatric conditions characterized by significant unmet medical need. Karuna is currently conducting a Phase 2 clinical trial of its lead product candidate, KarXT (Karuna-Xanomeline-Trospium), for the treatment of acute psychosis in patients with schizophrenia. Karuna also plans to initiate clinical trials of KarXT to evaluate its potential therapeutic benefit in other central nervous system disorders, including psychosis in Alzheimer's disease, as well as pain.

    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 our cash resources, the timing of advancing of our planned clinical trials and regulatory filings, interim trial results, 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 costs and timing of establishing, equipping, 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, 2019. 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,

     

     

    2019

     

    2018

    2019

     

    2018

    Revenue

     

     

     

     

     

     

     

     

     

     

     

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    4,992

     

     

    $

    6,720

     

     

    $

    24,536

     

     

    $

    11,536

     

    General and administrative

     

     

    3,874

     

     

     

    1,426

     

     

     

    20,869

     

     

     

    2,974

     

    Total operating expenses

     

     

    8,866

     

     

     

    8,146

     

     

     

    45,405

     

     

     

    14,510

     

    Loss from operations

     

     

    (8,866

    )

     

     

    (8,146

    )

     

     

    (45,405

    )

     

     

    (14,510

    )

    Other income (expense):

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Interest income (expense)

     

     

     

     

     

    (11

    )

     

     

    11

     

     

     

    (407

    )

    Interest income

     

     

    1,092

     

     

     

    25

     

     

     

    2,517

     

     

     

    25

     

    Accretion of debt discount

     

     

     

     

     

    (180

    )

     

     

    (945

    )

     

     

    (2,176

    )

    Change in fair value of derivative

     

     

     

     

     

    (15

    )

     

     

    (135

    )

     

     

    (444

    )

    Total other income (expense), net

     

     

    1,092

     

     

     

    (181

    )

     

     

    1,448

     

     

     

    (3,002

    )

    Net loss before income taxes

     

     

    (7,774

    )

     

     

    (8,327

    )

     

     

    (43,957

    )

     

     

    (17,512

    )

    Income tax provision

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss attributable to common stockholders

     

    $

    (7,774

    )

     

    $

    (8,327

    )

     

    $

    (43,957

    )

     

    $

    (17,512

    )

    Net loss per share, basic and diluted

     

    $

    (0.32

    )

     

    $

    (693,917

    )

     

    $

    (3.68

    )

     

    $

    (4,378,000

    )

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

     

     

    24,430,145

     

     

     

    12

     

     

     

    11,958,152

     

     

     

    4

     

     

    Karuna Therapeutics, Inc.

    Unaudited Consolidated Balance Sheet Data

    (in thousands)

     

     

     

    December 31,

    2019

     

     

    December 31,

    2018

     

    Cash, cash equivalents and short-term investments

     

    $

    389,397

     

     

    $

    13,887

     

    Working capital

     

     

    389,748

     

     

     

    14,400

     

    Total assets

     

     

    393,024

     

     

     

    15,857

     

    Redeemable convertible preferred stock

     

     

    -

     

     

     

    41,965

     

    Total stockholders' equity (deficit)

     

    $

    389,916

     

     

    $

    (29,922

    )

     

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  17. Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced that Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics, will present at the Cowen and Company's 40th Annual Health Care Conference being held at the Boston Marriott Copley Place in Boston, MA. The Company is scheduled to present on Monday, March 2, 2020, at 11:20 a.m. ET.

    A live webcast of the presentation will also be available on the investor relations page of the Karuna corporate website at investors.karunatx.com. After the live webcast…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced that Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics, will present at the Cowen and Company's 40th Annual Health Care Conference being held at the Boston Marriott Copley Place in Boston, MA. The Company is scheduled to present on Monday, March 2, 2020, at 11:20 a.m. ET.

    A live webcast of the presentation will also be available on the investor relations page of the Karuna corporate website at investors.karunatx.com. After the live webcast, the event will remain archived on the Karuna website for 90 days.

    About Karuna

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

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  18. Announces new strategic drug discovery partnership with Charles River

    Opens new office dedicated to drug discovery and potential development of novel CNS therapeutics

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced an update on its research and development efforts in CNS. To accommodate continued growth in its drug discovery efforts, Karuna announced the opening of an office in Indianapolis, Indiana. Additionally, Karuna announced a new multi-year drug discovery collaboration with Charles River, a leading early-stage contract…

    Announces new strategic drug discovery partnership with Charles River

    Opens new office dedicated to drug discovery and potential development of novel CNS therapeutics

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced an update on its research and development efforts in CNS. To accommodate continued growth in its drug discovery efforts, Karuna announced the opening of an office in Indianapolis, Indiana. Additionally, Karuna announced a new multi-year drug discovery collaboration with Charles River, a leading early-stage contract research organization. The collaboration brings together decades of experience, drug discovery capabilities and expertise at both Charles River and Karuna.

    "We are excited to be expanding our discovery efforts that will broaden our early stage pipeline," said Steve Paul, M.D., chief executive officer, president, and chairman of Karuna. "Building on the successful Phase 2 data of our lead product candidate KarXT, we are now expanding our discovery efforts to pursue several novel CNS targets to advance next generation treatments for patients with a variety of disabling neuropsychiatric disorders. We aim to build a pipeline of product candidates targeting key neurotransmitter receptors to treat a broad range of disabling and debilitating CNS disorders through highly differentiated pharmacology."

    To date, Karuna has employed state-of-the-art chemical screening, hit to lead and lead optimization strategies and the collaboration with Charles River will leverage their end-to-end drug discovery and safety assessment platform to facilitate the selection of optimized drug candidates to advance into clinical development. "Both Karuna and Charles River have assembled an unparalleled team of experienced ‘drug hunters' with the potential to discover the next generation of novel CNS therapeutics," adds Dr. Paul.

    About Karuna

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

    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 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 our most recent Quarterly Report on Form 10-Q filed with the SEC and in other filings that Karuna makes with the SEC. 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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  19. Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced that Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics, will present at the 38th Annual J.P. Morgan Healthcare Conference being held at the Westin St. Francis Hotel in San Francisco, CA. The Company is scheduled to present on Thursday, January 16, 2020, at 11:00 a.m. PT.

    Karuna recently announced that KarXT met its primary endpoint in the Phase 2 clinical trial studying KarXT in acute psychosis in patients with schizophrenia. The company will…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced that Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics, will present at the 38th Annual J.P. Morgan Healthcare Conference being held at the Westin St. Francis Hotel in San Francisco, CA. The Company is scheduled to present on Thursday, January 16, 2020, at 11:00 a.m. PT.

    Karuna recently announced that KarXT met its primary endpoint in the Phase 2 clinical trial studying KarXT in acute psychosis in patients with schizophrenia. The company will discuss these results and other business updates during its presentation.

    A live webcast of the presentation will also be available on the investor relations page of the Karuna corporate website at investors.karunatx.com. After the live webcast, the event will remain archived on the Karuna website for 30 days.

    About Karuna

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

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  20. Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced that Andrew Miller, Ph.D., founder and chief operating officer at Karuna, will present and host investor meetings at the Piper Jaffray 31st Annual Healthcare Conference being held at the Lotte New York Palace in New York, NY. The Company is scheduled to present on Thursday, December 5, 2019, at 12:30 p.m. ET.

    A live webcast of the presentation will also be available on the investor relations page of the Karuna corporate website at investors.karunatx.com. After the live webcast…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced that Andrew Miller, Ph.D., founder and chief operating officer at Karuna, will present and host investor meetings at the Piper Jaffray 31st Annual Healthcare Conference being held at the Lotte New York Palace in New York, NY. The Company is scheduled to present on Thursday, December 5, 2019, at 12:30 p.m. ET.

    A live webcast of the presentation will also be available on the investor relations page of the Karuna corporate website at investors.karunatx.com. After the live webcast, the event will remain archived on the Karuna website for 90 days.

    About Karuna

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

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  21. Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced the pricing of its previously announced underwritten public offering of 2,600,000 shares of its common stock at a price to the public of $96.00 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. The offering is expected to close on November 25, 2019, subject to customary closing conditions. In addition, Karuna has granted the…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced the pricing of its previously announced underwritten public offering of 2,600,000 shares of its common stock at a price to the public of $96.00 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. The offering is expected to close on November 25, 2019, subject to customary closing conditions. In addition, Karuna has granted the underwriters a 30-day option to purchase an additional 390,000 shares of its common stock, at the public offering price, less the underwriting discounts and commissions.

    Goldman Sachs & Co. LLC and Citigroup are acting as joint book-running managers for the offering. Stifel, Nicolaus & Company, Incorporated is also acting as a book-running manager. JMP Securities LLC is acting as lead manager.

    A registration statement relating to these securities was filed with the Securities and Exchange Commission ("SEC") on November 18, 2019 and was declared effective by the SEC on November 20, 2019. The offering is being made only by means of a prospectus. A copy of the final prospectus relating to the offering will be filed with the SEC and may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone: 1-866-471-2526 or by emailing ; or Citigroup Global Markets Inc., Attention: Prospectus Department, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by phone at (800) 831-9146.

    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.

    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 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 our most recent Quarterly Report on Form 10-Q filed with the SEC and in other filings that Karuna makes with the SEC. 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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  22. Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced that it has commenced an underwritten public offering of 2,600,000 shares of its common stock. Karuna intends to grant the underwriters a 30-day option to purchase an additional 390,000 shares of its common stock, at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurances as to whether or when the offering may be completed, or as to the actual size and terms of the offering…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced that it has commenced an underwritten public offering of 2,600,000 shares of its common stock. Karuna intends to grant the underwriters a 30-day option to purchase an additional 390,000 shares of its common stock, at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurances as to whether or when the offering may be completed, or as to the actual size and terms of the offering. All the shares to be sold in the proposed offering will be sold by Karuna.

    Goldman Sachs & Co. LLC and Citigroup are acting as joint book-running managers for the offering. Stifel, Nicolaus & Company, Incorporated is also acting as a book-running manager. JMP Securities LLC is acting as a lead manager.

    A registration statement relating to these securities was filed with the Securities and Exchange Commission ("SEC") on November 18, 2019 but has not yet been declared effective. These securities may not be sold nor may offers to buy these securities be accepted prior to the time that the registration statement becomes effective. The offering will be made only by means of a prospectus. Copies of the registration statement and the preliminary prospectus relating to this offering may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone: 1-866-471-2526 or by emailing ; or Citigroup Global Markets Inc., Attention: Prospectus Department, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by phone at (800) 831-9146.

    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.

    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 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 our most recent Quarterly Report on Form 10-Q filed with the SEC and in other filings that Karuna makes with the SEC. 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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  23. KarXT Demonstrated Statistically Significant and Clinically Meaningful Improvement in Total PANSS Score at All Time Points Over Five Weeks and was Well-Tolerated Compared to Placebo

    No Evidence of Somnolence, Extrapyramidal Side Effects or Weight Gain Relative to Placebo

    Data Support Advancing KarXT to Phase 3 and Continued Development in Other CNS Disorders

    Conference Call and Webcast to Take Place Today at 8:30 a.m. EST

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric…

    KarXT Demonstrated Statistically Significant and Clinically Meaningful Improvement in Total PANSS Score at All Time Points Over Five Weeks and was Well-Tolerated Compared to Placebo

    Improvement in Total PANSS Score at Five Weeks was 11.6 Points Compared to Placebo (p<0.0001)

    No Evidence of Somnolence, Extrapyramidal Side Effects or Weight Gain Relative to Placebo

    Data Support Advancing KarXT to Phase 3 and Continued Development in Other CNS Disorders

    Conference Call and Webcast to Take Place Today at 8:30 a.m. EST

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced results from its Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia. In the clinical trial, KarXT demonstrated a statistically significant and clinically meaningful 11.6 point mean reduction in total Positive and Negative Syndrome Scale (PANSS) score compared to placebo (p<0.0001) and also demonstrated good overall tolerability. A statistically significant reduction in the secondary endpoints of PANSS-Positive and PANSS-Negative scores were also observed (p<0.001).

    KarXT was well tolerated in the Phase 2 trial, with similar discontinuation rates between KarXT (20%) and placebo (21%). The number of discontinuations due to treatment emergent adverse events (AEs) were equal in the KarXT and placebo arms (N=2 in each group).

    KarXT is an oral coformulation of xanomeline (a novel muscarinic receptor agonist) and trospium (a muscarinic receptor antagonist) designed to treat psychosis and related symptoms through preferential stimulation of muscarinic receptors in the central nervous system (CNS). This combination has the potential to be a new option for treating the difficult symptoms of debilitating CNS disorders, such as schizophrenia, without subjecting patients to the problematic side effects associated with current antipsychotic standard of care therapies.

    "The results of the Phase 2 trial are impressive and encouraging because they indicate that KarXT, if approved, could represent a game-changing therapeutic advance in the treatment of patients with schizophrenia," said Jeffrey Lieberman, M.D., professor and chairman of the Department of Psychiatry, Columbia University, College of Physicians and Surgeons and a member of Karuna's scientific advisory board. "The effectiveness of antipsychotics has been limited by the frequent and serious side effects of first- and second-generation drugs which are difficult for many patients to tolerate, are potentially harmful, and lead to high rates of discontinuation and relapse. In addition to its novel mechanism of action, KarXT could be a new therapeutic option that has the potential to offer robust efficacy devoid of weight gain, metabolic effects and extrapyramidal side effects."

    In the clinical trial, patients demonstrated a clinically meaningful and statistically significant 11.6 point mean reduction over placebo in total PANSS score, the trial's primary efficacy endpoint. The magnitude of the improvement with KarXT compares favorably to meta-analyses of published clinicals trials of currently approved antipsychotic medicines which reported an average difference of nine to ten points in PANSS score versus placebo. Historically, changes as small as five points have supported the approval of current antipsychotics.

    Overall, KarXT was well tolerated in the clinical trial, with similar discontinuation rates of patients on KarXT, 20%, and placebo, 21%. The number of discontinuations due to treatment emergent AEs were equal in the KarXT and placebo arms (N=2 in each group). The overall AE rate of patients on KarXT was 54% vs. 43% on placebo, with the most common AEs being constipation, nausea, dry mouth, dyspepsia, and vomiting. The tolerability of KarXT was also reflected in the trial's high rate of dose escalation. In the trial, 91% of KarXT treated patients escalated to the increased dose which was similar to the escalation rate with placebo. Occurrences of somnolence, weight gain, and extrapyramidal symptoms were also similar to placebo. One serious adverse event (SAE) was experienced in the drug treatment arm, in which the patient discontinued treatment and subsequently sought hospital care for worsening psychosis, meeting the regulatory definition of an SAE.

    "The schizophrenia treatment landscape has remained rather stagnant for decades with therapeutic options relying on discoveries dating back to the 1950s," said Steve Paul, M.D., chief executive officer, president, and chairman of Karuna. "KarXT and its novel muscarinic receptor mechanism of action represent the potential to become a true advancement in how schizophrenia is treated, allowing patients relief from their debilitating psychotic symptoms without experiencing some of the very troubling side effects associated with current treatments."

    Muscarinic acetylcholine receptors emerged in the 1990s as a promising alternative target to dopamine-receptor based treatments for treating psychosis, but adverse side effects limited their development as a therapeutic option. It is believed that these side effects were the result of the stimulation of muscarinic receptors in peripheral tissues. Karuna addressed this issue by combining xanomeline, a novel muscarinic receptor agonist that preferentially stimulates M1 and M4 muscarinic receptors, with trospium, an approved muscarinic receptor antagonist that does not measurably cross the blood-brain barrier, confining its effects to peripheral tissues. The resulting therapeutic, known as KarXT, was designed to activate muscarinic receptors in the CNS while avoiding the side effects associated with activating muscarinic receptors in peripheral tissues.

    "We are extremely pleased with these results, as the 11.6-point PANSS score separation from placebo far exceeded the five-point minimum improvement that has historically supported approval of current antipsychotics," said Stephen Brannan, M.D., chief medical officer of Karuna. "With this information, and following our anticipated end-of-Phase 2 meeting with the FDA in the second quarter of 2020, we will work to initiate a Phase 3 clinical trial of KarXT in patients with schizophrenia by the end of 2020. We also plan to further analyze these results to better understand the potential of KarXT in patients with schizophrenia experiencing negative and cognitive symptoms, and to explore other CNS disorders that could benefit from this approach, such as psychosis in Alzheimer's disease as well as the management of pain."

    About the Trial

    The Phase 2, randomized, double-blind, placebo-controlled, inpatient trial enrolled 182 adult patients, age 18 to 60, who had been diagnosed with DSM-5 schizophrenia and were experiencing acute psychosis. Patients were washed-out of antipsychotic medicines and randomized 1:1 to receive either KarXT or placebo for five weeks. The primary outcome measure of the trial was the change from baseline on the total PANSS score on KarXT vs. placebo treatment at week five.

    KarXT was dosed as xanomeline 50 mg/trospium 20 mg twice a day for two days and then increased to xanomeline 100 mg/trospium 20 mg starting on day three. Beginning on day eight, if KarXT was well tolerated, an option was given to escalate the dose of KarXT to xanomeline 125 mg/trospium 30 mg twice a day. If a patient escalated to the highest dose, the dose could be decreased back to xanomeline 100 mg/trospium 20 mg twice per day, based on tolerability, if needed. No dose changes were allowed during the last two weeks of the trial.

    About Schizophrenia

    Schizophrenia is a chronic, disabling disorder typically diagnosed in late teenage years or early adulthood. Characterized by recurring episodes of psychosis requiring long-term treatment with antipsychotic drugs in most patients, it affects more than 21 million people worldwide and 2.7 million Americans (0.5% - 1.0% of U.S. population).

    At least one-third of patients with schizophrenia fail to respond to current treatments, with 74% of patients discontinuing within 18 months of initiation. People with schizophrenia have a 10- to 15-year reduction in life expectancy and struggle to maintain meaningful interpersonal relationships. The World Health Organization ranks psychosis as the third-most disabling medical condition in the world.

    Conference Call and Webcast Information

    Karuna will hold a webcast and conference call this morning at 8:30 a.m. EST to provide results from its Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia. The dial-in numbers are 1-855-548-1216 for domestic callers and 1-409-216-6318 for international callers. The conference ID number for the live call will be 9498519. A live webcast of the conference call will also be available on the investor relations page of the Karuna Therapeutics corporate website at www.karunatx.com. After the live webcast, the event will remain archived on the Karuna Therapeutics website for three months.

    About Karuna

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

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  24. Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced it will hold a webcast and conference call on Monday, November 18, 2019 at 8:30 a.m. EST to provide results from its Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia.

    The dial-in numbers are 1-855-548-1216 for domestic callers and 1-409-216-6318 for international callers. The conference ID number for the live call will be 9498519. A live webcast of the conference call will also be available on the investor relations page of the…

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced it will hold a webcast and conference call on Monday, November 18, 2019 at 8:30 a.m. EST to provide results from its Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia.

    The dial-in numbers are 1-855-548-1216 for domestic callers and 1-409-216-6318 for international callers. The conference ID number for the live call will be 9498519. A live webcast of the conference call will also be available on the investor relations page of the Karuna Therapeutics corporate website at www.karunatx.com. After the live webcast, the event will remain archived on the Karuna Therapeutics website for three months.

    About Karuna

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

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    • Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia remains on track with topline data expected in late 2019
    • Phase 1b clinical trials for the treatment of psychosis in Alzheimer's disease and pain on track to commence by the end of 2019
    • Cash, cash equivalents and short-term investment balance of $161.6 million to fund development of novel CNS pipeline

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company primarily focused on developing novel therapies to address disabling neuropsychiatric conditions, today announced financial results for the third quarter 2019 and provided a general business update.

    "At Karuna our mission is to develop first-in-class therapeutics…

    • Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia remains on track with topline data expected in late 2019
    • Phase 1b clinical trials for the treatment of psychosis in Alzheimer's disease and pain on track to commence by the end of 2019
    • Cash, cash equivalents and short-term investment balance of $161.6 million to fund development of novel CNS pipeline

    Karuna Therapeutics, Inc. (NASDAQ:KRTX), a clinical-stage biopharmaceutical company primarily focused on developing novel therapies to address disabling neuropsychiatric conditions, today announced financial results for the third quarter 2019 and provided a general business update.

    "At Karuna our mission is to develop first-in-class therapeutics that dramatically improve the lives of people living with schizophrenia, Alzheimer's disease and pain," stated Steve Paul, M.D., chief executive officer, president and chairman of Karuna Therapeutics. "It has been a very productive quarter as we work towards this mission and look forward to presenting the results of our Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia later this year. KarXT offers a new mechanism of action with the potential for not only improved efficacy, but safety and tolerability as well. If approved, KarXT could substantially improve the treatment paradigm for people suffering from this debilitating and potentially fatal disease."

    Business Highlights

    • KarXT for the treatment of acute psychosis in patients with schizophrenia. KarXT, a proprietary oral modulator of muscarinic receptors, is the Company's lead product candidate that 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 (CNS).
      • Phase 2 topline results expected in late 2019. Karuna has completed enrollment of a multi-site, double-blind, placebo-controlled, inpatient Phase 2 clinical trial of KarXT in 182 schizophrenia patients with acute psychosis. The trial's primary endpoint is the change from baseline in Positive and Negative Syndrome Score (PANSS) total scores for KarXT compared to placebo treated patients. In addition to reporting topline efficacy results, Karuna will also provide an overview of the drug's safety and tolerability. Secondary endpoints include changes in PANSS Marder Factor (including the negative symptom factor), cognitive battery and the clinical global impression severity scale (CGI-S). The Phase 2 clinical trial design represents the same fundamental design and primary endpoint utilized in the previous third-party xanomeline Phase 2 trial in psychosis in schizophrenia, as well as in pivotal trials for several currently approved antipsychotic medicines.
      • Blinded Phase 2 safety data and Independent Safety Monitoring Committee (ISMC) suggests KarXT continues to offer improved tolerability compared to xanomeline. The Phase 2 trial uses a flexible-dose design with the potential to escalate the dose after the first week of treatment based solely on the tolerability experienced by each individual patient. The low dose of KarXT in the Phase 2 study is equivalent to the high dose in the previous third-party xanomeline-alone Phase 2 trials in Alzheimer's disease and schizophrenia. Approximately 90% of patients in Karuna's Phase 2 trial escalated to the highest dose (125mg/30mg twice daily) and less than 5% of patients who dose-escalated have subsequently de-escalated back to the 100mg/20mg twice daily dose level. The early termination rate has been approximately 20-25%, which is lower than the 38% early termination reported in a meta-analysis of 167 placebo-controlled studies in schizophrenia patients with acute psychosis. Additionally, the ISMC completed review of the unblinded safety and tolerability data at three prespecified intervals and each time recommended the trial continue without modification.
    • Advancing CNS pipeline with two Phase 1b clinical programs initiating by the end of 2019. The Company's pipeline is built on the therapeutic potential of KarXT and the established link between muscarinic receptor stimulation in the CNS and its ability to impact a wide range of disorders including schizophrenia, Alzheimer's disease psychosis and various forms of pain.
      • Phase 1b clinical trial of KarXT in healthy elderly volunteers. Expanding upon the two previously completed Phase 1 trials that demonstrated the tolerability of KarXT in healthy volunteers, this trial will investigate the safety and tolerability of KarXT in elderly volunteers. Xanomeline-alone was previously studied by a third party in a placebo-controlled, double-blind Phase 2 clinical trial in 343 Alzheimer's patients that reported both the reduction of emergence and remission of psychotic symptoms and suggested cognitive benefits.
      • Phase 1b clinical trial of KarXT in experimentally induced pain. Preclinical data published in peer-reviewed scientific journals link the stimulation of muscarinic receptors, and specifically xanomeline, to analgesic benefits. Xanomeline has demonstrated robust activity in several animal models of different types of pain including post-operative, inflammatory and neuropathic pain.
    • Karuna added to the Russell 2000 and 3000 Indexes. In September, Karuna was added to the Russell 2000 and 3000 Indexes as part of the FTSE Russell's quarterly update. The Russell U.S. Indexes are widely used by investment managers and institutional investors for passive funds and investment products and as benchmarks for active investment strategies.
    • Continued recruitment of top talent across key functional areas. Karuna has recently expanded its Senior Discovery Team with the addition of James E. Audia, Ph.D. and James A. Monn, Ph.D. As Karuna pursues development of KarXT for additional indications it is also scaling up discovery efforts to expand its product pipeline. "Dr. Audia and Dr. Monn are very accomplished scientific leaders and drug discovery experts who join Karuna at an exciting time," said Steve Paul, M.D., chief executive officer, president and chairman of Karuna. "Their decades long careers will support our early discovery programs focused on developing novel therapies to address disabling neuropsychiatric conditions." Dr. Audia joins as head of medicinal chemistry and senior adviser. He brings over 20 years of medicinal chemistry experience in both the pharmaceutical and biotechnology industries, having most recently served as the chief scientific officer at Constellation Pharmaceuticals and prior to that as distinguished Lilly scholar at Eli Lilly. Dr. Monn joins Karuna as a vice president of medicinal chemistry and brings over 20 years of drug discovery experience as a senior research fellow at Eli Lilly.

    Third Quarter 2019 Financial Results

    The Company reported a net loss of $9.0 million for the third quarter 2019 as compared to $6.2 million for the prior year period. The increase in net loss for the year was due to increased research and development expenses, as well as an increase in general and administrative expenses primarily related to investments in the Company's infrastructure as a publicly traded company.

    Research and development expenses for the third quarter 2019 were $5.8 million as compared to $1.4 million for the prior year period. The increase in research and development expenses was primarily driven by increased spending related to the Company's Phase 2 clinical trial for the treatment of schizophrenia, Phase 1b trial in experimentally induced pain, increased personnel-related costs due to the increase in employee headcount, as well as expenses associated with consulting fees and our discovery programs.

    General and administrative expenses were $4.1 million for the third quarter 2019 as compared to $1.1 million for the prior year period. The increase in general and administrative expenses was primarily due to an increase in employee headcount inclusive of the impact of stock-based compensation and higher costs related to the support of business operations as a publicly traded company.

    The Company ended the quarter with $161.6 million in cash, cash equivalents and short-term investments compared to $13.9 million as of December 31, 2018. The increase was primarily the result of the completion of the Company's initial public offering which generated $93.0 million in net proceeds and Series B Preferred Stock Financing which generated net proceeds of $74.8 million. The Company expects that current cash, cash equivalents, and short-term investments as of September 30, 2019, will enable the Company to fund its operating expenses and capital expenditure requirements into the second half of 2021. This includes multiple clinical and development milestones including a Phase 3 clinical trial of KarXT in psychosis related to schizophrenia.

    About Karuna

    Karuna is an innovative clinical-stage biopharmaceutical company primarily focused on developing novel therapies to address disabling neuropsychiatric conditions characterized by significant unmet medical need. Karuna is currently conducting a Phase 2 clinical trial of its lead product candidate, KarXT (Karuna-Xanomeline-Trospium), for the treatment of acute psychosis in patients with schizophrenia. Karuna also plans to initiate clinical trials of KarXT to evaluate its potential therapeutic benefit in other central nervous system disorders, including psychosis in Alzheimer's disease, as well as pain.

    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 our cash resources, the timing of advancing of our planned clinical trials, interim trial results, 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 costs and timing of establishing, equipping, 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, and other risks set forth under the heading "Risk Factors" of our Quarterly Report on Form 10-Q for the third quarter ended September 30, 2019. 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 Statements of Operations

    (in thousands, except share and per share data)

     

     

     

    Three Months Ended

    September 30,

     

     

    Nine Months Ended

    September 30,

     

     

     

    2019

     

     

    2018

     

     

    2019

     

     

    2018

     

    Revenue

     

     

     

     

     

     

     

     

     

     

     

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    5,793

     

     

    $

    1,417

     

     

    $

    19,544

     

     

    $

    4,816

     

    General and administrative

     

     

    4,103

     

     

     

    1,056

     

     

     

    16,995

     

     

     

    1,548

     

    Total operating expenses

     

     

    9,896

     

     

     

    2,473

     

     

     

    36,539

     

     

     

    6,364

     

    Loss from operations

     

     

    (9,896

    )

     

     

    (2,473

    )

     

     

    (36,539

    )

     

     

    (6,364

    )

    Other income (expense):

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Interest income (expense)

     

     

     

     

     

    192

     

     

     

    11

     

     

     

    (396

    )

    Interest income

     

     

    858

     

     

     

     

     

     

    1,425

     

     

     

     

    Accretion of debt discount

     

     

     

     

     

    (1,324

    )

     

     

    (945

    )

     

     

    (1,996

    )

    Change in fair value of derivative

     

     

     

     

     

    (2,633

    )

     

     

    (135

    )

     

     

    (429

    )

    Total other income (expense), net

     

     

    858

     

     

     

    (3,765

    )

     

     

    356

     

     

     

    (2,821

    )

    Net loss before income taxes

     

     

    (9,038

    )

     

     

    (6,238

    )

     

     

    (36,183

    )

     

     

    (9,185

    )

    Income tax provision

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss attributable to common stockholders

     

    $

    (9,038

    )

     

    $

    (6,238

    )

     

    $

    (36,183

    )

     

    $

    (9,185

    )

    Net loss per share, basic and diluted

     

    $

    (0.39

    )

     

    $

    (1,247,600

    )

     

    $

    (4.67

    )

     

    $

    (4,592,500

    )

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

     

     

    22,907,349

     

     

     

    5

     

     

     

    7,755,137

     

     

     

    2

     

     

    Karuna Therapeutics, Inc.

    Unaudited Balance Sheet Data

    (in thousands)

     

     

     

    September 30,

    2019

     

     

    December 31,

    2018

     

    Cash, cash equivalents and short-term investments

     

    $

    161,605

     

     

    $

    13,887

     

    Working capital

     

     

    162,395

     

     

     

    14,400

     

    Total assets

     

     

    164,227

     

     

     

    15,857

     

    Redeemable convertible preferred stock

     

     

    -

     

     

     

    41,965

     

    Total stockholders' equity (deficit)

     

    $

    162,530

     

     

    $

    (29,922

    )

     

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