Karuna Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides General Business Update
New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults under review with a Prescription Drug User Fee Act (PDUFA) action date of
Results from the Phase 3 EMERGENT-2 trial of KarXT in schizophrenia published in
Announced appointments of
Previously announced proposed acquisition of Karuna by
“2023 was a landmark year for Karuna, marked by the FDA acceptance of our NDA for KarXT for the treatment of schizophrenia in adults, with a potential launch in the second half of this year, and the continued advancement of our late-stage pipeline of KarXT as a potential adjunctive treatment for schizophrenia and in psychosis in Alzheimer’s disease,” said
KEY PIPELINE HIGHLIGHTS
Karuna is advancing a pipeline of novel drug candidates for the treatment of various psychiatric and neurological conditions led by KarXT (xanomeline-trospium), an oral, investigational M1/M4-preferring muscarinic agonist.
KarXT
The NDA for KarXT for the treatment of schizophrenia in adults is under review by the
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Schizophrenia
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The NDA for KarXT for the treatment of schizophrenia in adults was accepted for review by the FDA in the fourth quarter of 2023 and assigned a PDUFA action date of
September 26, 2024 .
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Results from the EMERGENT-2 trial published in
The Lancet inDecember 2023 . The published manuscript, titled “Efficacy and safety of the muscarinic receptor agonist KarXT (xanomeline-trospium) in schizophrenia (EMERGENT-2) in theUSA : results from a randomised, double-blind, placebo-controlled, flexible-dose phase 3 trial,” is available online, and appears in theJanuary 13, 2024 print issue. -
Announced
positive results from the Phase 1b Ambulatory Blood Pressure Monitoring trial in schizophrenia in the fourth quarter of 2023. Results from the trial demonstrate that KarXT was not associated with clinically meaningful increases in blood pressure in adults with schizophrenia.
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Presented additional data from the EMERGENT program at the 2023
Neuroscience Education Institute (NEI) Congress and the CNS Summit in the fourth quarter of 2023. Poster presentations included new pooled efficacy and safety analyses across the three completed EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials, where:- KarXT demonstrated statistically significant and clinically meaningful improvements in symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 5 compared to placebo (p<0.0001), the primary endpoint in the trials.
- KarXT demonstrated statistically significant improvements across all secondary efficacy measures, including the PANSS positive subscale score (p<0.0001), PANSS negative subscale score (p<0.0001), PANSS Marder negative factor score (p<0.0001), and CGI-S score (p<0.0001).
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KarXT was generally well tolerated, with common adverse reactions (>5% and at least twice placebo) being mostly cholinergic in nature, mild to moderate in severity, and transient over time. Further, KarXT was not associated with weight gain, adverse changes in metabolic parameters, or extrapyramidal symptoms.
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Interim long-term data from the EMERGENT-4 & 5 trials to be presented at upcoming medical congresses in the spring.
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The NDA for KarXT for the treatment of schizophrenia in adults was accepted for review by the FDA in the fourth quarter of 2023 and assigned a PDUFA action date of
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Adjunctive treatment in schizophrenia
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Topline data from the Phase 3 ARISE trial evaluating the efficacy and safety of KarXT in schizophrenia when combined with a background antipsychotic is anticipated in 2025.
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Topline data from the Phase 3 ARISE trial evaluating the efficacy and safety of KarXT in schizophrenia when combined with a background antipsychotic is anticipated in 2025.
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Psychosis in Alzheimer’s disease
- Topline data from the Phase 3 ADEPT-1 and ADEPT-2 trials evaluating KarXT in psychosis in Alzheimer’s disease is anticipated in 2026.
Early-stage and discovery programs
The Karuna pipeline also includes clinical-stage candidate KAR-2618, a TRPC4/5 inhibitor for the treatment of mood and anxiety disorders, as well as pre-clinical muscarinic, TRPC4/5, and target-agnostic compounds for the treatment of psychiatric and neurological conditions.
- The Company is on track to initiate a Phase 1b trial of KAR-2618 in major depressive disorder (MDD) in 2024.
BUSINESS UPDATES
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Key leadership appointments. In
January 2024 , the Company appointedAndrew Miller , Ph.D. as President of Research and Development andMia Kelley , J.D. as General Counsel.Dr. Miller succeedsSteve Paul , M.D., who continues to serve on the Company’s Board of Directors and was appointed as a member of the Company’sScientific Advisory Board .
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Proposed acquisition of
Karuna Therapeutics byBristol Myers Squibb . InDecember 2023 , Karuna andBristol Myers Squibb announced they have entered into a definitive merger agreement under whichBristol Myers Squibb has agreed to acquire Karuna for$330.00 per share in cash, for a total equity value of$14.0 billion , or$12.7 billion net of estimated cash acquired. The Boards of Directors of both companies have unanimously approved the transaction. The transaction is expected to close in the first half of 2024, subject to customary closing conditions, including approval of Karuna stockholders and receipt of required regulatory approvals.
ANTICIPATED UPCOMING MILESTONES
- Topline data from the Phase 3 EMERGENT-4 trial (2H 2024)
- Topline data from the Phase 3 EMERGENT-5 trial (2H 2024)
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KarXT in schizophrenia PDUFA action date (
September 26, 2024 ) - Launch of KarXT in schizophrenia, if approved (2H 2024)
- Initiation of the Phase 1b trial of KAR-2618 in major depressive disorder (2024)
- Topline data from the Phase 3 ARISE trial (2025)
- Topline data from the Phase 3 ADEPT-1 trial (2026)
- Topline data from the Phase 3 ADEPT-2 trial (2026)
FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS
The Company reported a net loss of
Research and development expenses were
General and administrative expenses were
The Company ended the year 2023 with
About
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 our ongoing and planned clinical trials and regulatory filings, our goals to develop and commercialize our product candidates, our liquidity and capital resources, the proposed acquisition of Karuna by
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Three Months Ended |
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Year Ended |
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2023 |
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2022 |
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2023 |
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2022 |
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License and other revenue |
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$ |
— |
|
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$ |
5,278 |
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$ |
654 |
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$ |
10,637 |
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Operating expenses: |
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Research and development |
|
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82,192 |
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66,004 |
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|
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364,101 |
|
|
|
224,247 |
|
General and administrative |
|
|
47,394 |
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|
|
24,310 |
|
|
|
131,330 |
|
|
|
76,066 |
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Total operating expenses |
|
|
129,586 |
|
|
|
90,314 |
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|
|
495,431 |
|
|
|
300,313 |
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Loss from operations |
|
|
(129,586 |
) |
|
|
(85,036 |
) |
|
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(494,777 |
) |
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(289,676 |
) |
Other income, net: |
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Interest income |
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16,285 |
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9,567 |
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61,179 |
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|
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14,178 |
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Sublease income |
|
|
147 |
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|
|
147 |
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|
|
588 |
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|
580 |
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Total other income, net |
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16,432 |
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9,714 |
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61,767 |
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14,758 |
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Net loss before income taxes |
|
|
(113,154 |
) |
|
|
(75,322 |
) |
|
|
(433,010 |
) |
|
|
(274,918 |
) |
Income tax provision |
|
|
(670 |
) |
|
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(890 |
) |
|
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(670 |
) |
|
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(1,418 |
) |
Net loss attributable to common stockholders |
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$ |
(113,824 |
) |
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$ |
(76,212 |
) |
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$ |
(433,680 |
) |
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$ |
(276,336 |
) |
Net loss per share, basic and diluted |
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$ |
(3.01 |
) |
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$ |
(2.22 |
) |
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$ |
(11.73 |
) |
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$ |
(8.74 |
) |
Weighted average common shares outstanding used in computing net loss per share, basic and diluted |
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37,780,998 |
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|
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34,406,182 |
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36,959,049 |
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31,629,013 |
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Cash, cash equivalents and investments |
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$ |
1,260,780 |
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$ |
1,124,044 |
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Working capital |
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1,247,184 |
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1,120,823 |
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Total assets |
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1,336,209 |
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1,163,334 |
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Total stockholders’ equity |
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$ |
1,254,235 |
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$ |
1,126,238 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20240222875274/en/
Investors:
+1 (617) 352-9917
asmith@karunatx.com
Media:
+1 (917) 647-0159
julie.ciardiello@karunatx.com
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