KRTX Karuna Therapeutics Inc.

98.37
-1.4  -1%
Previous Close 99.77
Open 100.2
52 Week Low 52.62
52 Week High 123.73
Market Cap $2,636,961,897
Shares 26,806,566
Float 12,156,384
Enterprise Value $2,332,479,089
Volume 97,028
Av. Daily Volume 169,588
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Upcoming Catalysts

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

Drug Stage Notes
KarXT
Acute psychosis in patients with schizophrenia
Phase 3
Phase 3
Phase 3 trial to be initiated by the end of 2020.
KarXT
Pain in healthy volunteers
Phase 1b
Phase 1b
Phase 1b data released August 3, 2020. Insufficient evidence of an analgesic benefit compared to placebo. Development to be discontinued for pain indication.

Latest News

  1. 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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  2. 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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  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 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.

    View Full Article Hide Full Article
  4. 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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  5.  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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