On November 9, 2021 Brickell Biotech, Inc. ("Brickell" or the "Company") (Nasdaq: BBI), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of dermatologic, autoimmune, and other debilitating diseases, reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Vical, NOV 9, 2021, View Source [SID1234595211]).

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"This has been an exciting period for Brickell, as we announced positive data from our Phase 3 pivotal clinical studies of sofpironium bromide gel, 15% and expanded our pipeline with the acquisition of a Phase 1-ready DYRK1A inhibitor and cutting-edge platform with broad potential in autoimmune and inflammatory disorders. We look to build on this momentum by focusing on several near-term clinical, regulatory, and operational milestones that we believe can drive our growth," commented Robert Brown, Chief Executive Officer of Brickell. "We were pleased to announce last month that the Phase 3 Cardigan I and Cardigan II studies of sofpironium bromide gel, 15% in patients with primary axillary hyperhidrosis, or excessive underarm sweating, achieved statistical significance on all primary and secondary efficacy endpoints. Based on the positive results from these studies, we expect to submit an NDA for sofpironium bromide gel, 15% to the FDA in mid-2022. As we plan the commercial strategy for sofpironium bromide gel, 15%, if approved, we are evaluating all available options to maximize commercial product success and long-term value for the company."
"We look forward to advancing the development of our DYRK1A inhibitor programs that aim to restore immune balance with a novel and differentiated small molecule approach, which we believe will help improve the lives of patients with autoimmune diseases. To this end, we expect to advance our lead DYRK1A inhibitor program, BBI-02, into a Phase 1 clinical study in the first half of 2022, with topline results anticipated by the end of 2022. We look forward to providing updates on this planned study in the coming months," continued Mr. Brown.
Business and Recent Developments
•Reported positive topline results from two U.S. Phase 3 pivotal clinical studies of sofpironium bromide gel, 15%, each of which enrolled approximately 350 patients who were nine years of age and older with primary axillary hyperhidrosis. Both studies achieved statistical significance on all primary and secondary efficacy endpoints, and data demonstrated that sofpironium bromide gel, 15% was generally well-tolerated.
•Acquired exclusive, worldwide rights to research, develop, and commercialize novel therapeutics generated from a proprietary DYRK1A inhibitor platform with broad potential in autoimmune and inflammatory diseases. The acquisition includes BBI-02, a Phase 1-ready, highly selective, and orally bioavailable DYRK1A inhibitor; BBI-03, a topically applied preclinical DYRK1A inhibitor; and a platform of DYRK1A inhibitors with potential to create next-generation kinase inhibitors targeting neuroinflammatory and autoimmune disorders.
•Hosted a Key Opinion Leader ("KOL") webinar featuring a presentation by KOL Bernard Khor, M.D., Ph.D., Benaroya Research Institute at Virginia Mason, who discussed the latest findings on the novel target DYRK1A, its role in autoimmune and inflammatory diseases, and the broad therapeutic potential of restoring immune homeostasis by inhibiting DYRK1A. A replay of the event can be found on the Events and Presentations section of the Company’s website at View Source

•Expanded leadership team by appointing Dr. Monica Luchi as Chief Medical Officer to oversee the Company’s clinical development strategy, including for the DYRK1A inhibitor pipeline, and medical affairs functions.
•Brickell’s development partner, Kaken Pharmaceutical Co., Ltd. ("Kaken"), continued conduct of a Phase 1 clinical study in Japan assessing the pharmacokinetics (PK), safety, and efficacy of sofpironium bromide gel in patients with primary palmoplantar hyperhidrosis.
•Strengthened cash balance with net proceeds of $8.9 million received from a public offering of the Company’s common stock in October 2021.
Upcoming Milestones
•Prospective NDA submission to the U.S. FDA for sofpironium gel, 15% in mid-2022.
•Intend to progress BBI-02 into a Phase 1 clinical study in Canada in the first half of 2022, with topline results expected by the end of 2022.
•Expect to conduct formulation development activities for BBI-03 throughout 2022, and to select and initiate development of a lead next-generation candidate from the DYRK1A inhibitor platform with potential for the treatment of neuroinflammatory and/or autoimmune diseases.
Third Quarter 2021 Financial Results
The Company reported cash and cash equivalents of $21.4 million as of September 30, 2021, compared to $30.1 million as of December 31, 2020.
Revenue was $0.1 million for the third quarter of 2021, which consisted of royalty revenue recognized related to sales of ECCLOCK in Japan by Kaken. Revenue was $0.1 million for the third quarter of 2020, which was driven by collaboration revenue recognized for research and development funding provided by Kaken to Brickell in 2018.
Research and development expenses were $10.2 million for the third quarter of 2021, compared to $1.3 million for the third quarter of 2020. This increase was primarily due to a $4.8 million expense recorded related to the upfront payment in cash and shares of our common stock to Voronoi Inc. in exchange for exclusive, worldwide rights to the proprietary DYRK1A inhibitor platform and an increase of $3.8 million in clinical costs related to sofpironium bromide.
General and administrative expenses were $3.3 million for the third quarter of 2021, compared to $3.2 million for the third quarter of 2020, remaining generally consistent with the comparable period.
Brickell’s net loss was $13.3 million for the third quarter of 2021 compared to $4.3 million for the third quarter of 2020.
Conference Call and Webcast Information
Brickell’s management will host a conference call today at 4:30 p.m. ET to discuss the financial results and recent corporate developments. The dial-in number for the conference call is 1-877-705-6003 for domestic participants and 1-201-493-6725 for international participants, with Conference ID #13723603. A live webcast of the conference call can be accessed at View Source or through the Brickell Biotech website at View Source A replay will be available on this website shortly after conclusion of the event for approximately 90 days.
About Sofpironium Bromide
Sofpironium bromide is a new chemical entity that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are designed to exert their action locally and are potentially rapidly metabolized into a less active form once absorbed into the blood. Brickell has developed sofpironium bromide gel, 15% as a potential best-in-class, self-administered, once daily, topical therapy for the treatment of primary axillary hyperhidrosis, also known as excessive underarm sweating. Sofpironium bromide gel, 15% has completed a U.S. Phase 3 pivotal clinical program for the treatment of primary axillary hyperhidrosis, which achieved statistical significance on all primary and secondary efficacy endpoints, and sofpironium bromide gel, 15% was generally well-tolerated. Sofpironium bromide gel, 5% is approved in Japan for the same indication

under the brand name ECCLOCK. Sofpironium bromide was discovered at Bodor Laboratories, Inc. by Dr. Nicholas Bodor D.Sc., d.h.c. (multi), HoF, Graduate Research Professor Emeritus, University of Florida.
About the DYRK1A Inhibitor Platform
In August 2021, Brickell acquired exclusive, worldwide rights to research, develop, and commercialize novel therapeutics generated from a proprietary DYRK1A inhibitor platform. These novel DYRK1A inhibitors aim to restore immune balance in patients whose immune system has become dysregulated. Based on the promising preclinical efficacy data generated to date on these novel DYRK1A inhibitor programs, Brickell believes this platform has the potential to offer first-in-class, new and potent therapies across a wide array of autoimmune and inflammatory diseases. The initial lead program that the Company expects to advance is BBI-02, a Phase 1-ready, highly selective, and orally bioavailable DYRK1A inhibitor that has demonstrated promising results in various preclinical models, including atopic dermatitis and rheumatoid arthritis. Preclinical data have shown BBI-02 to drive regulatory T-cell differentiation while dampening pro-inflammatory TH17 cells and MyD88/IRAK4-related signaling pathways. Unlike many existing therapies, as well as those currently being investigated, BBI-02 may have the ability to target both the adaptive and innate immune imbalance simultaneously, potentially resulting in, or substantially achieving, restoration of immune homeostasis that, if proven, would represent a paradigm shift in the treatment of certain autoimmune and inflammatory diseases. The platform also includes BBI-03, a topically applied preclinical DYRK1A inhibitor, and has the potential to create next generation kinase inhibitors (NCEs) targeting neuroinflammatory and autoimmune disorders.

On November 9, 2021 Kureha Corporation reported (Press release, Kureha Corporation, NOV 9, 2021, View Source [SID1234595210])

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FY2021 half-year operating profit at ¥11.4bn (up 84% YOY, up 52% from initial forecast); Full-year forecast revised upward to ¥19.5bn (up 13% YOY, up 30% from initial forecast)
◼ FY2021 year-end dividend forecast raised to ¥100 per share, up from ¥85 in prior year
◼ FY2021 business conditions characterized by:-Pandemic-impacted consumer behaviors (under stay-home restrictions) and robust outdoor leisure demand persisting during 1H, which is likely to diminish in 2H-Continued strong demand for automotive lithium-ion batteries as EV production and sales expand across the globe, driven by nations’ environment and economic initiatives-Surging fuel and raw materials prices due to tight oil supply, natural resources deficit and logistics/supply chain disruptions in post-pandemic recovery-Impact of reduced car production on Kureha Group businesses is limited and minimal
◼ Kureha Group has implemented strategic measures to:-Increase sales volumes of high-margin grades and items in PVDF, PPS, ‘NEW Krewrap’ and other product lines, while reducing cost via improved efficiency and expanded production output-Adjust sales prices to align with rising fuel and raw material costs Further risks:-Restriction of energy use in China may affect local manufacturing operations (Changshu PVDF facilities) and procurement of raw materials for PVDF manufacturing in Japan (Iwaki Factory)- Delays in reflecting a further and rapid rise in fuel/raw material prices

Factors attributing to changes in operating profit
AM: Increased sales volumes of PVDF, PPS and other advanced materials
SC: Industrial chemicals returned to generating profit
SP: Higher home products and packaging film volumes
CO: Profit maintained despite delays in civil engineering projects
OO: Absence of prior year’s post-typhoon waste treatment projects

Factors attributing to changes in operating profit
AM: Better-than-expected volume growth for PVDF and carbon products, an increase in equity in PPSrelated affiliate’s earnings
SC: Front-loaded deliveries of agrochemicals (2H→1H) SP: Continued pandemic-impacted demand for home products, fewer expenses
CO: Improved sales cost due to mix changes and cost reduction
OO: Higher sales volumes in the low-PCB waste treatment business

On November 9, 2021 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported that it has completed an amendment to Pulmatrix’s agreement with Cipla Technologies, LLC ("Cipla") for the development and commercialization of Pulmazole (Press release, Pulmatrix, NOV 9, 2021, View Source [SID1234595208]). The completion of the amendment resolves Pulmatrix’s previously disclosed dispute with Cipla regarding the continued funding of the development costs for Pulmazole.

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Pursuant to the 2nd Amendment Cipla will continue to reimburse Pulmatrix for 50% of all third-party costs for the development of Pulmazole, provided Cipla will only be required to reimburse Pulmatrix for 40% of Pulmatrix dedicated personnel and consulting costs ("direct costs"). Upon the timely achievement of certain development milestones, Cipla will reimburse another 10% of Pulmatrix’s "direct costs". The development milestones for Pulmatrix’s planned Phase 2b clinical trial include the dosing of 25% of participants in the clinical trial by June 30, 2023, and the delivery of top-line data results to the joint steering committee for the program by June 30, 2024. If the development milestones are not achieved within 9-months of such dates either party may terminate its obligation to fund its share of development costs. Pulmatrix also granted Cipla exclusive rights to the development and commercialization of Pulmazole in the "Cipla Territory" (India, Nepal, Yemen, Iran, South Africa, Sri Lanka, Myanmar and Algeria) in exchange for, under certain circumstances, 2% royalties on net sales of Pulmazole in the Cipla Territory. For more information about the 2nd Amendment please refer to Pulmatrix’s Current Report on Form 8-K to be filed with U.S. Securities and Exchange Commission on or around the date of this press release.

Pulmatrix successfully completed a Type C Meeting with the U.S. Food and Drug Administration (FDA) in February of 2020 and intends to initiate a Phase 2b clinical study of Pulmazole in allergic bronchopulmonary aspergillosis (ABPA) with registration endpoints in Q1 2023 with topline data expected Q2 2024, which may enable a Phase 3 registration study.

"We are pleased to have come to this resolution which will enable the continued development of Pulmazole globally with our valued partners at Cipla," said Ted Raad, Chief Executive Officer of Pulmatrix. "After a successful Type C Meeting with the FDA, we are now ready to resume clinical activities with Pulmazole which has the potential to address the underlying cause of ABPA while avoiding the side effects of oral antifungals and prolonged steroid treatment."

On November 9, 2021 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 third quarter ended September 30, 2021 and provided a corporate update (Press release, Intra-Cellular Therapies, NOV 9, 2021, View Source [SID1234595183]).

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"We are excited about the progress we have made during the third quarter in the commercialization of CAPLYTA in schizophrenia and in the advancement of our development programs. In addition, our bipolar depression launch preparations are progressing well and we have substantially completed our sales force expansion," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.

Third Quarter Financial Highlights

Total revenues were $22.2 million for the third quarter of 2021, compared to $7.4 million of total revenues for the third quarter of 2020. Net product revenues of CAPLYTA were $21.6 million for the third quarter of 2021, compared to $7.4 million in net product revenues of CAPLYTA for the same period in 2020.
Cost of product sales were $2.0 million in the third quarter of 2021 compared to $0.6 million for the same period in 2020.
Research and development (R&D) expenses for the third quarter of 2021 were $27.0 million, compared to $10.3 million for the third quarter of 2020. This increase is due to higher lumateperone clinical trial costs and an increase in other development program costs.
Selling, general and administrative (SG&A) expenses were $70.5 million for the third quarter of 2021, compared to $52.5 million for the same period in 2020. This increase is primarily due to an increase in marketing and commercialization costs.
Net loss for the third quarter of 2021 was $76.9 million compared to a net loss of $55.2 million for the same period in 2020.
Cash, cash equivalents, restricted cash and investment securities totaled $478.7 million at September 30, 2021, compared to $658.8 million at December 31, 2020.
COMMERCIAL HIGHLIGHTS

Bipolar depression launch preparations continue to progress, and we have substantially completed our sales force expansion. If approved, we expect to launch CAPLYTA in bipolar depression immediately following U.S. Food and Drug Administration (FDA) approval.
Our hybrid commercialization model, combining virtual and in-person engagements, and our digital marketing initiatives continue to deliver consistent revenue and prescription growth despite COVID-19 disruptions affecting the medical care of patients with schizophrenia.
Third quarter CAPLYTA results reflect continued prescription growth, increasing total prescriptions by 15% versus the second quarter of 2021 and approximately 200% versus the same period in 2020.
CLINICAL HIGHLIGHTS

R&D Day Highlighting Development Programs:

The Company hosted an R&D day highlighting its research and development programs. Presentations and discussions from the Company’s management team and external key opinion leaders described different aspects of our broad pipeline, including our lumateperone, ITI-1284, PDE1 inhibitors and ITI-333 platforms.
Lumateperone:

Bipolar Depression Program: The lumateperone sNDAs for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate are under review by the FDA. The Prescription Drug User Fee Act (PDUFA) target action date is December 17, 2021 for these applications.
Adjunctive MDD program: Patient enrollment has been initiated in global studies 501 and 502. These are Phase 3 double blind, placebo-controlled, 6-week studies evaluating lumateperone 42mg as adjunctive treatment to anti-depressants for patients having an inadequate response to antidepressant therapy. The primary endpoint is change from baseline versus placebo on the MADRS total score at week 6, and the CGI-S scale is the key secondary endpoint.
Mixed Features program: Study 403 is ongoing and is evaluating lumateperone 42mg in patients with MDD and in patients with bipolar depression who exhibit mixed features. We expect to complete this study in the second half of 2022.
Lumateperone Long Acting Injectable (LLAI) formulation: Study ITI-007-025, a Phase 1 single ascending dose study of LLAI, is ongoing. We expect to complete this study later this year.
Publications: Announced the publication of Study 404, a Phase 3 clinical study evaluating lumateperone as monotherapy in patients with bipolar depression. The article titled "Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated with Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial," was published online in The American Journal of Psychiatry.
Other Programs:

ITI-1284 program: We have initiated our program for the development of ITI-1284-ODT-SL for the treatment of agitation in patients with probable Alzheimer’s disease. Clinical conduct in this program is expected to commence early in 2022. Studies in dementia-related psychosis and certain depressive disorders in the elderly are planned for the first half of 2022.
Phosphodiesterase type I inhibitor (PDE1) program:
Our Phase 2 clinical program evaluating lenrispodun (ITI-214) in Parkinson’s disease has been initiated, and we expect to commence patient enrollment in the first half of 2022.
We announced four publications highlighting the beneficial effects of PDE1 inhibition with lenrispodun on cardiovascular function in patients with heart failure and in age-related vascular changes in preclinical models associated with stiffening of arteries, vascular endothelial dysfunction, and increased inflammation. In addition, a novel cellular mechanism by which PDE1 stimulates cardiac contraction was described in one of these studies. These findings have broad implications, as cardiovascular dysfunction and inflammation play important roles across multiple chronic and age-related diseases.
ITI-333 program in opioid use disorder: ITI-333 is a novel compound that acts as a partial agonist at mu-opioid (MOP) receptors and as antagonists at the serotonin 5HT2A receptors. At MOP receptors, it acts as a partial agonist signaling through G-protein pathways, but it acts as an antagonist at beta-arrestin pathways. These characteristics and results from early clinical and preclinical models highlight the potential of ITI-333 to address important unmet therapeutic needs in opioid use disorder and pain. A Phase 1 single ascending dose study, evaluating the safety, tolerability and pharmacokinetics of ITI-333 in healthy volunteers, is ongoing. Results from this study are anticipated in the fourth quarter of 2021.
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. The live webcast and subsequent replay may be accessed by visiting the Company’s website at www.intracellulartherapies.com. Please connect to the Company’s website at least 5-10 minutes prior to the live webcast to ensure adequate time for any necessary software download. Alternatively, please call 1-(844) 835-6563 (U.S.) or 1-(970) 315-3916 (international) to listen to the live conference call. The conference ID number for the live call is 3650108. Please dial in approximately 10 minutes prior to the call.

CAPLYTA (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.

Important Safety Information

Boxed Warning: 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.

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.
Sleepiness and Trouble Concentrating. 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, moderate or strong CYP3A4 inhibitors and UGT 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. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.

Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

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

About CAPLYTA (lumateperone)

CAPLYTA 42mg/day is an oral, once daily atypical antipsychotic approved for the treatment of schizophrenia of adults. While the mechanism of action of CAPLYTA in the treatment of schizophrenia 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 investigated for the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders. CAPLYTA is not FDA approved for these disorders.

On November 9, 2021 Avenue Therapeutics, Inc. (NASDAQ: ATXI) ("Avenue"), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, reported the pricing of an underwritten public offering with gross proceeds to the Company expected to be approximately $2.6 million, before deducting underwriting discounts and commissions and other estimated expenses payable by the Company (Press release, Avenue Therapeutics, NOV 9, 2021, View Source [SID1234595127]). The offering equates to 1,946,787 shares at a price to the public of $1.34 per share. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

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In addition, the Company granted the underwriters a 45-day option to purchase additional shares of common stock, representing up to 15% of the number of the shares, solely to cover over-allotments, if any, which would increase the total gross proceeds of the offering to approximately $3 million, if the over-allotment option is exercised in full.

The offering is expected to close on November 12, 2021, subject to the satisfaction of customary closing conditions.

Aegis Capital Corp. is acting as sole book-running manager for the offering.

The securities described above are being offered by Avenue Therapeutics pursuant to an effective registration statement on Form S-3 (No. 333-259850) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on October 1, 2021. A final prospectus (the "Prospectus") describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the Prospectus may be obtained, when available, by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010. Before investing in this offering, interested parties should read in their entirety the Prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such Prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sales of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.