On March 1, 2023 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported operating results for the fourth quarter and year ended December 31, 2022 and provided business updates (Press release, AnaptysBio, MAR 1, 2023, View Source [SID1234627967]).

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"2022 was a significant year of transition for AnaptysBio as we refocused the company on broadly advancing our portfolio of best-in-class immune cell modulators. We are excited by the near-term initiation of our two global Phase 2b trials across rosnilimab, our PD-1 agonist, in rheumatoid arthritis and ANB032, our BTLA agonist, in atopic dermatitis. We believe their mechanisms of action have the potential to meaningfully impact large and significantly underserved patient populations, to restore immune balance by acting directly on cell types mediating disease pathology," said Daniel Faga, interim president and chief executive officer of AnaptysBio. "As we continue to progress our strategic portfolio review, we are well capitalized to deliver on multiple Phase 2 readouts across our wholly owned checkpoint agonists, as well as to advance ANB033, our anti-CD122 antagonist, through clinical proof-of-concept."

Rosnilimab (PD-1 agonist antibody)

•Rosnilimab, its investigational wholly owned PD-1 agonist, demonstrates best-in-class activity in vitro with superior inhibition of T cell proliferation, reduction in inflammatory cytokine secretion (Th1, Th2, Th17) and depletion of PD-1+ T cells via effector function compared to Lilly PD-1 agonist
•PD-1+ T cells are clinically validated drivers of disease in rheumatoid arthritis (RA)
◦RA patient synovial biopsies have dense T cell infiltrates, with >80% of T cells expressing PD-1 and insufficient PD-L1 expression to down-regulate T cell activity
◦Rosnilimab targets multiple distinct inflammatory mechanisms addressed by approved therapies to treat RA
•Initiation in Q3 2023 of a global Phase 2b trial in moderate-to-severe RA
◦Multi-hundred patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab for approximately 6 months on well-established endpoints including ACR20/50/70 and DAS28
◦Top-line interim data anticipated by mid-year 2025
•Second global Phase 2 trial, in an indication to be announced, with study initiation anticipated by year-end 2023

ANB032 (BTLA agonist antibody)
•ANB032, its investigational wholly owned BTLA agonist, demonstrates best-in-class activity in vitro with superior inhibition of T cell proliferation and reduction in inflammatory cytokine secretion (Th1, Th2, Th17) compared to Lilly BTLA agonist
•While Th2 targeted therapies provide benefit to patients with chronic moderate-to-severe atopic dermatitis (AD), there is compelling evidence that AD is broader than a Th2 driven disease, as Th1, Th17 and other cell types, including dendritic cells, may contribute significantly to its pathogenesis
◦ANB032 inhibits inflammatory activity of Th1, Th2 and Th17 and modulates additional cell types such as B cells and dendritic cells, with the potential for broader, deeper and more durable responses than more narrowly targeted interventions
•Initiation in Q2 2023 of a global Phase 2b trial in moderate-to-severe AD
◦160 patient placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for 12 weeks on well-established endpoints, including EASI75 and IGA 0/1
◦Top-line interim data anticipated by year-end 2024
ANB033 (anti-CD122 antagonist antibody)
•ANB033, its investigational wholly owned anti-CD122 antagonist antibody, targets the common beta subunit shared by the IL-15 and IL-2 receptors
◦IL-15 signaling mediates the survival and maintenance of tissue resident memory T cells (TRM)
◦The presence of long-lived and persistent TRM have been shown to drive tissue-specific immune-mediated inflammation
•IND anticipated H1 2024
Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing
•Imsidolimab, its investigational wholly owned anti-IL-36R antagonist antibody, is in Phase 3 trials for generalized pustular psoriasis (GPP)
◦Top-line data from the GEMINI-1 Phase 3 trial anticipated Q4 2023
◦Plan to out-license imsidolimab prior to potential FDA approval
•Etokimab, its investigational wholly owned anti-IL-33 antagonist antibody, is Phase 2/3-ready for the treatment of respiratory disorders
◦No further internal investment in etokimab is being pursued
GSK Immuno-Oncology Financial Collaboration
•Dostarlimab, an anti-PD-1 antagonist antibody, cobolimab, an anti-TIM-3 antagonist antibody, and GSK4074386, an anti-LAG-3 antagonist antibody, were discovered at AnaptysBio and licensed by GSK
•JEMPERLI (dostarlimab-gxly) has the potential for a first-in-class approval in primary advanced or recurrent endometrial cancer after meeting the primary endpoint in the pivotal RUBY Phase 3 trial demonstrating JEMPERLI plus chemotherapy significantly improved PFS versus chemotherapy plus placebo
◦Regulatory submissions anticipated H1 2023
◦GSK expects to publish full results in a medical journal and present at an upcoming scientific meeting

•Dostarlimab plus ZEJULA in the pivotal FIRST Phase 3 trial in 1st line ovarian cancer is ongoing with an interim analysis expected in H2 2023
•Dostarlimab plus cobolimab plus chemotherapy vs. dostarlimab plus chemotherapy is in the pivotal COSTAR Lung Phase 3 trial in advanced non-small cell lung cancer in patients who have progressed on prior anti-PD-(L)1 therapy
Stock Repurchase Plan
•In January 2023, the Board of Directors authorized a Stock Repurchase Plan under which the Company may repurchase up to $50.0 million of the Company’s outstanding common stock. The Stock Repurchase Plan will expire on December 31, 2023, may be suspended or discontinued at any time, and does not obligate the company to acquire any amount of common stock.
Fourth Quarter Financial Results
•Cash, cash equivalents and investments totaled $584.2 million as of December 31, 2022, compared to $615.2 million as of December 31, 2021, for a decrease of $31.0 million. The decrease relates primarily to cash used for operating activities offset by cash received from the Zejula royalty sale and stock option exercises.
•Collaboration revenue was $6.8 million and $10.3 million for the three and twelve months ended December 31, 2022, compared to $1.0 million and $63.2 million for the three and twelve months ended December 31, 2021. The increase for the three months ended December 31, 2022 relates primarily to one development milestone achieved for cobolimab and no development milestones achieved during the three months ended December 31, 2021. The decrease for the twelve months ended December 31, 2022 relates primarily to four development milestones achieved for JEMPERLI for the twelve months ended December 31, 2021, and one development milestone achieved during the twelve months ended December 31, 2022.
•Research and development expenses were $23.4 million and $88.8 million for the three and twelve months ended December 31, 2022, compared to $26.8 million and $98.5 million for the three and twelve months ended December 31, 2021. The decrease for the three and twelve months ended December 31, 2022 was due primarily to reduced clinical and manufacturing costs for the Company’s programs. The R&D non-cash, stock-based compensation expense was $1.8 million and $6.8 million for the three and twelve months ended December 31, 2022, as compared to $1.5 million and $5.9 million in the same period in 2021.
•General and administrative expenses were $9.4 million and $36.6 million for the three and twelve months ended December 31, 2022, compared to $5.4 million and $21.5 million for the three and twelve months ended December 31, 2021. The increase was primarily due to stock compensation expense and $3.8 million of costs incurred from personnel changes in the first quarter of 2022. The G&A non-cash, stock-based compensation expense was $4.9 million and $20.6 million for the three and twelve months ended December 31, 2022, which includes $3.2 million of the $3.8 million one-time costs described earlier as compared to $2.5 million and $9.5 million in the same period in 2021.
•Non-cash interest expense was $4.3 million and $21.1 million for the three and twelve months ended December 31, 2022, compared to $1.5 million for the three and twelve months ended December 31, 2021. The increase in non-cash interest expense during the period is directly related to the interest expense accrued on the liability related to the sale of future royalties, of which we had a full year of expense during 2022 as compared to one month of expense during 2021. We also had an additional sale of future royalties in 2022 compared to period in 2021.
•Net loss was $26.4 million and $128.7 million for the three and twelve months ended December 31, 2022, or a net loss per share of $0.93 and $4.57, compared to a net loss of $32.5 million and $57.8 million for the three and twelve months ended December 31, 2021, or a net loss per share of $1.18 and $2.11.

On March 1, 2023 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that it has received authorization from Health Canada to proceed with a feasibility and safety study of Alpha DaRT in the treatment of liver metastases, subject to final approval by an institutional Research Ethics Board, which the Company expects to receive in the coming weeks (Press release, Alpha Tau Medical, MAR 1, 2023, View Source [SID1234627966]). The study is planned to be conducted at the McGill University Health Center in Montreal, Canada.

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The trial will seek to recruit 10 patients who are eligible for a two-staged hepatectomy to resect liver metastases of colorectal cancer. Specifically, in the first stage, as many metastatic tumors as possible will be surgically removed in a non-curative intervention while Alpha DaRT sources will be inserted into a separate tumor, and in the second stage, after allowing for the resected liver to regenerate naturally, the portion of the liver with the Alpha DaRT sources will be surgically removed.

The study primarily aims to examine the feasibility of delivering Alpha DaRT sources into the liver metastases, as well as the safety of utilizing the Alpha DaRT sources in the liver by assessing the frequency and severity of related adverse events. The study will also examine Alpha DaRT’s efficacy in terms of radiological response, assessed after insertion of the Alpha DaRT sources, and via pathological response assessed after the second stage of surgery.

Alpha Tau CEO Uzi Sofer commented, "The authorization by Health Canada for this study to proceed represents an important milestone for the Company. This trial examining the use of Alpha DaRT in liver metastases for the first time signifies a big step forward in our overall strategy to broaden the use of the Alpha DaRT in hard-to-treat indications, including other cancers such as those of the brain, lung, pancreas, vulva and breast."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On March 1, 2023 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that management will participate in the following upcoming investor conferences (Press release, Alector, MAR 1, 2023, View Source [SID1234627965]).

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Cowen 43rd Annual Health Care Conference (Boston, Massachusetts)
Tuesday, March 7, 2023, at 10:30 a.m. ET, panel
Stifel 2023 CNS Days (Virtual)
Tuesday, March 28, 2023, at 12:00 p.m. ET, fireside chat
A webcast of each conference presentation will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source Replays of the Cowen and Stifel webcasts will be available on the Alector website for 30 and 90 days, respectively, following the presentation dates.

On March 1, 2023 Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, reported its financial results for the fourth quarter and year ended December 31, 2022 and provided a corporate update (Press release, Intra-Cellular Therapies, MAR 1, 2023, View Source [SID1234627957]).

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"The robust growth of CAPLYTA in 2022 marked an extraordinary year for our company. During the year we launched our new bipolar depression indication for CAPLYTA and made considerable progress in advancing our late and early-stage clinical programs," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "I am very proud of our accomplishments and the strong foundation we have built. We expect 2023 to be another year of significant growth for CAPLYTA and the company."

Fourth Quarter Financial Highlights

Net product sales of CAPLYTA were $87.4 million for the fourth quarter of 2022, compared to $25.5 million for the same period in 2021, representing a year-over-year increase of 243% and a 22% increase over the third quarter of 2022

Net loss for the fourth quarter of 2022 was $44.0 million compared to a net loss of $85.7 million for the same period in 2021

Cost of product sales were $6.8 million in the fourth quarter of 2022 compared to $2.5 million for the same period in 2021

Selling, general and administrative (SG&A) expenses were $94.6 million for the fourth quarter of 2022, compared to $79.7 million for the same period in 2021. This increase is primarily due to an increase in commercialization, marketing and advertising costs.

Research and development (R&D) expenses for the fourth quarter of 2022 were $33.9 million, compared to $29.5 million for the fourth quarter of 2021. This increase is primarily due to higher lumateperone and non-lumateperone project costs, including the ITI-1284, ITI-214, and ITI-333 programs.

2022 Financial Highlights

Total revenues were $250.3 million for the full year 2022, compared to $83.8 million for the full year 2021, representing an increase of 199%. Net product sales of CAPLYTA were $249.1 million for the full year 2022, compared to $81.7 million for the full year 2021, representing an increase of 205

Net loss for the year ended December 31, 2022 was $256.3 million or $2.72 per share (basic and diluted) compared to a net loss of $284.1 million or $3.50 per share (basic and diluted) for the year ended December 31, 2021

Cost of product sales was approximately $20.4 million for the year ended December 31, 2022, compared to $8.0 million for the year ended December 31, 2021

SG&A expenses were $358.8 million for the year ended December 31, 2022, compared to $272.6 million for the year ended December 31, 2021. This increase is primarily due to an increase in commercialization, marketing and advertising costs

R&D expenses were $134.7 million for the year ended December 31, 2022, compared to $88.8 million for the year ended December 31, 2021. This increase is primarily due to higher lumateperone clinical and non-clinical project costs, and higher non-lumateperone project costs, including the ITI-1284, ITI-214, and ITI-333 programs

Cash, cash equivalents, restricted cash and investment securities totaled $593.7 million at December 31, 2022, compared to $413.7 million at December 31, 2021.

Fiscal 2023 Financial Outlook

CAPLYTA 2023 net product sales are expected to be $430 to $455 million

SG&A expenses for the full year 2023 are expected to be $420 to $450 million, including approximately $29 million of non-cash, share-based compensation expense. SG&A guidance reflects our commitment to continue to support CAPLYTA commercialization through investments in our sales and marketing activities

R&D expenses for the full year 2023 are expected to be $195 to $220 million, including approximately $17 million of non-cash, share-based compensation expense. R&D guidance reflects investments to support our robust pipeline including our lumateperone clinical programs in mood disorders, our long-acting injectable program, and our other platforms including our phosphodiesterase-1 inhibitors, ITI-1284 and ITI-333.

Expectations (in $ millions)
low high
CAPLYTA Net Product Sales

$ 430 $ 455
SG&A expenses (GAAP)

$ 420 $ 450
R&D expenses (GAAP)

$ 195 $ 220

COMMERCIAL HIGHLIGHTS

Successfully launched CAPLYTA for the treatment of bipolar depression in adults. CAPLYTA is the only U.S. Food and Drug Administration (FDA) approved treatment for depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults as monotherapy and as adjunctive therapy with lithium or valproate.

CAPLYTA prescriptions tripled in 2022, following the launch in bipolar depression, representing 193% total prescription growth in 2022 over 2021. CAPLYTA’s strong uptake continued in the fourth quarter with total prescriptions increasing by 225% compared to the fourth quarter of 2021. Fourth quarter CAPLYTA total prescriptions increased sequentially by 21% versus the third quarter of 2022 while total prescriptions in the overall oral antipsychotic market remained flat.

In 2022 we received FDA approval and subsequently launched two new dosage strengths of CAPLYTA, 10.5 mg and 21 mg. These dosage strengths expand the patient population for CAPLYTA by providing dosage recommendations for patients taking strong or moderate CYP3A4 inhibitors and patients with moderate or severe hepatic impairment.

CAPLYTA maintained broad coverage in the Medicare Part D and Medicaid channels, with greater than 98% of lives covered. CAPLYTA has broad Commercial coverage and we expect to expand this coverage to 90% of lives by the end of the first quarter of 2023.

Our LytaLink patient and prescriber support program continues to be very effective in supporting patient access to CAPLYTA.

CLINICAL HIGHLIGHTS

Lumateperone:

Adjunctive MDD program: Patient enrollment is ongoing in Studies 501 and 502, our global Phase 3 major depressive disorder (MDD) studies evaluating lumateperone 42 mg for the adjunctive treatment of depression in patients who have partially responded to antidepressants. Subject to the results of Studies 501 and 502, we expect to file a supplemental New Drug Application with the FDA for approval of lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD in 2024.

Mixed Features program: We expect to report topline results from Study 403 in the first quarter of 2023. Study 403 is a global clinical trial evaluating lumateperone 42 mg in patients with MDD and in patients with bipolar depression who exhibit mixed features. The primary endpoint is change from baseline versus placebo on the Montgomery-Asberg Depression Rating scale (MADRS) total score at week 6, and the key secondary endpoint is the Clinical Global Impression (CGI-S) scale.

Lumateperone Long Acting Injectable (LAI) formulation: The goal of our program is to develop LAI formulations that are effective, safe and well-tolerated with treatment durations of one month and longer. In 2022 we completed a Phase 1 single ascending dose study with our initial formulation. We have progressed the preclinical development of other formulations and anticipate initiating Phase 1 single ascending dose studies with several formulations in 2023.

Other pipeline programs:

ITI-1284-ODT-SL program: ITI-1284 is a deuterated form of lumateperone, a new chemical entity formulated as an oral disintegrating tablet for sublingual administration.

In 2022, we completed a food intake study and a water intake study. In these studies, ITI-1284 was generally safe and well-tolerated. Previously, we completed Phase 1 safety studies in which ITI-1284 was generally safe and well tolerated in normal healthy volunteers and normal healthy elderly volunteers. Other Phase 1 studies are ongoing or planned and our toxicology program for ITI-1284 continues to progress.

In 2023, we plan to begin Phase 2 programs in agitation in patients with Alzheimer’s disease (AD), generalized anxiety disorder, and psychosis in patients with AD

Phosphodiesterase type I inhibitor (PDE1) program: Our portfolio of PDE1 inhibitors is being developed to treat diseases in which PDE1 activity is highly active

Lenrispodun (ITI-214) is our lead PDE1 inhibitor compound. We completed Phase 1 trials including drug-drug interaction, bioavailability from scale up batches and food effect studies. We also conducted a Phase 1/2 trial in patients with Parkinson’s disease to evaluate safety and tolerability in this patient population. We expect to commence clinical conduct in a Phase 2 trial in Parkinson’s disease later this month.

We have an active Investigational New Drug application to evaluate our newest candidate within the PDE1 inhibitor program, ITI-1020, as a novel cancer immunotherapy. A Phase 1 program in healthy volunteers is anticipated to commence in the first half of 2023

ITI-333 program: ITI-333, a 5-HT2A receptor antagonist and µ-opioid receptor partial agonist, provides potential utility in the treatment of opioid use disorder, pain and mood disorders. A multiple ascending dose study in healthy volunteers evaluating pharmacokinetics (PK), safety and tolerability commenced clinical conduct in the first quarter of 2023. Our neuroimaging study is ongoing.

Conference Call and Webcast Details

The Company will host a live conference call and webcast today at 8:30 AM Eastern Time to discuss the Company’s financial results and provide a corporate update. To attend the live conference call by phone please use this registration link (https://register.vevent.com/register/BI6a2f59692620422cadb6bf7504d5378b). All participants must use the link to complete the online registration process in advance of the conference call.

The live and archived webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

CAPLYTA (lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.

Important Safety Information

Boxed Warnings

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.

Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria.

Warnings & Precautions: Antipsychotic drugs have been reported to cause

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.

Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room

Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued

Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment

Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors

Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension

Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA
Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold

Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them

Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics

Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors

Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Dose reduction is recommended for patients with moderate or severe hepatic impairment.

Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth.

CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.

Please click here to see full Prescribing Information including Boxed Warning.

About CAPLYTA (lumateperone)

CAPLYTA 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

Lumateperone is being studied for the treatment of major depressive disorder, and other neuropsychiatric and neurological disorders. Lumateperone is not FDA-approved for these disorders.

On March 1, 2023 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that Bill Newell, Chief Executive Officer, will participate in an Ovarian Cancer panel discussion at the Cowen 43rd Annual Health Care Conference on Wednesday, March 8, 2023, at 9:10 a.m. ET / 6:10 a.m. PT in Boston, MA (Press release, Sutro Biopharma, MAR 1, 2023, View Source [SID1234627955]).

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The presentation will be accessible through the News & Events page of the Investor Relations section of the company’s website at www.sutrobio.com. An archived replay will be available for at least 30 days after the event.