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BOSTON--(BUSINESS WIRE)--Nov 3, 2022--
Karuna Therapeutics, Inc. (NASDAQ: KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced financial results for the third quarter of 2022 and provided a general business update.
“The third quarter was truly a transformational time for Karuna, marked by the positive results from the Phase 3 EMERGENT-2 trial and further diversification of our pipeline through the initiation of ADEPT-1, our Phase 3 trial in psychosis in Alzheimer’s disease, the third therapeutic area we’re evaluating with KarXT,” said Steve Paul, M.D., chief executive officer, president, and chairman. “The work our team has accomplished this quarter illustrates and underscores our ongoing commitment to developing and delivering transformational medicines – such as KarXT, a true ‘pipeline in a product’ – to people living with serious psychiatric and neurological conditions.”
Pipeline Updates
Karuna is advancing a pipeline of novel drug candidates for the treatment of various psychiatric and neurological conditions. The clinical pipeline is led by KarXT (xanomeline-trospium), an oral investigational medicine with a novel mechanism of action mediated via muscarinic cholinergic receptors, that is currently being evaluated in ongoing Phase 3 clinical trials as a potential treatment for schizophrenia as a monotherapy and adjunctive therapy, as well as psychosis in Alzheimer’s disease.
KarXT for the treatment of schizophrenia:
KarXT for the treatment of psychosis in Alzheimer’s disease:
Discovery and early-stage pipeline:
Corporate Updates
Anticipated Upcoming Milestones
Third Quarter 2022 Financial Results
The Company reported a net loss of $77.0 million for the third quarter of 2022, as compared to $50.9 million for the prior year period. The increase in net loss for the quarter was driven by research and development expenses related to the Company’s enrollment of the Phase 3 EMERGENT and ARISE trials, NDA-supporting activities, increased employee headcount across the organization, and higher stock-based compensation expense.
Research and development expenses were $62.0 million for the third quarter of 2022, as compared to $38.8 million for the prior year period. The increase in research and development expenses for the quarter was primarily driven by expenses related to the Company’s Phase 3 EMERGENT, ARISE and ADEPT trials, manufacturing to support ongoing and planned clinical trials, activities to support the Company’s planned NDA submission and potential commercialization of KarXT for schizophrenia, personnel-related costs due to the increase in employee headcount, and higher stock-based compensation expense.
General and administrative expenses were $19.1 million for the third quarter of 2022, as compared to $12.4 million for the prior year period. The increase in general and administrative expenses was primarily due to an increase in employee headcount and an increase in stock-based compensation expense.
The Company ended the quarter with $1.2 billion in cash, cash equivalents and available-for-sale investment securities compared to $494.0 million as of December 31, 2021. The increase was primarily the result of the completion of the Company’s public offering in August 2022, which resulted in net proceeds of $819.1 million. The Company expects that current cash, cash equivalents and available-for-sale investment securities as of September 30, 2022, will enable to Company to fund operating expenses and capital expenditure requirements through the end of 2025.
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 serious mental illness. Utilizing our extensive knowledge of neuroscience, we are harnessing the untapped potential of the brain in pursuit of novel pathways to develop medicines that make meaningful differences in peoples’ lives. For more information, please visit www.karunatx.com.
Forward-Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about the timing of our ongoing and planned clinical trials and regulatory filings, our goals to develop and commercialize our product candidates, our liquidity and capital resources and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to obtain necessary funding, our ability to generate positive clinical trial results for our product candidates and other risks inherent in clinical development, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, risks relating to business interruptions resulting from the coronavirus (COVID-19) pandemic, and other risks set forth under the heading “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2021. 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 |
|
| Nine Months Ended |
| ||||||||||||
|
| September 30, |
|
| September 30, |
| ||||||||||||
|
| 2022 |
|
|
| 2021 |
|
| 2022 |
|
| 2021 |
| |||||
License and other revenue |
| $ | 81 |
|
|
| $ | — |
|
| $ | 5,359 |
|
| $ | — |
| |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
Research and development |
|
| 61,950 |
|
|
|
| 38,775 |
|
|
| 158,243 |
|
|
| 83,108 |
| |
General and administrative |
|
| 19,125 |
|
|
|
| 12,393 |
|
|
| 51,756 |
|
|
| 32,554 |
| |
Total operating expenses |
|
| 81,075 |
|
|
|
| 51,168 |
|
|
| 209,999 |
|
|
| 115,662 |
| |
Loss from operations |
|
| (80,994 | ) |
| — |
|
| (51,168 | ) |
|
| (204,640 | ) |
|
| (115,662 | ) |
Other income (loss), net: |
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
Interest income |
|
| 3,884 |
|
|
|
| 114 |
|
|
| 4,611 |
|
|
| 363 |
| |
Sublease income |
|
| 147 |
|
|
|
| 122 |
|
|
| 433 |
|
|
| 131 |
| |
Impairment loss on right-of-use assets |
|
| — |
|
|
|
| — |
|
|
| — |
|
|
| (677 | ) | |
Total other income (loss), net |
|
| 4,031 |
|
|
|
| 236 |
|
|
| 5,044 |
|
|
| (183 | ) | |
Net loss before income taxes |
|
| (76,963 | ) |
|
|
| (50,932 | ) |
|
| (199,596 | ) |
|
| (115,845 | ) | |
Income tax provision |
|
| — |
|
|
|
| — |
|
|
| (528 | ) |
|
| — |
| |
Net loss attributable to common stockholders |
| $ | (76,963 | ) |
|
| $ | (50,932 | ) |
| $ | (200,124 | ) |
| $ | (115,845 | ) | |
Net loss per share, basic and diluted |
| $ | (2.38 | ) |
|
| $ | (1.72 | ) |
| $ | (6.52 | ) |
| $ | (4.00 | ) | |
Weighted average common shares outstanding used in computing net loss per share, basic and diluted |
|
| 32,349,111 |
|
|
|
| 29,572,289 |
|
|
| 30,693,117 |
|
|
| 28,953,654 |
|
Karuna Therapeutics, Inc. Unaudited Consolidated Balance Sheet Data (in thousands) | ||||||||
|
| September 30, |
|
| December 31, |
| ||
Cash, cash equivalents and investments |
| $ | 1,192,034 |
|
| $ | 493,991 |
|
Working capital |
|
| 1,178,933 |
|
|
| 497,121 |
|
Total assets |
|
| 1,228,412 |
|
|
| 527,671 |
|
Total stockholders’ equity |
| $ | 1,183,955 |
|
| $ | 502,026 |
|
View source version on businesswire.com:https://www.businesswire.com/news/home/20221103005136/en/
CONTACT: Investor Contact:
Alexis Smith
518-338-8990
asmith@karunatx.com
Media Contact:
Lauren Sneider
917-886-0247
lsneider@karunatx.com
KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: MENTAL HEALTH FDA HEALTH CLINICAL TRIALS PHARMACEUTICAL BIOTECHNOLOGY
SOURCE: Karuna Therapeutics, Inc.
Copyright Business Wire 2022.
PUB: 11/03/2022 06:30 AM/DISC: 11/03/2022 06:32 AM
http://www.businesswire.com/news/home/20221103005136/en