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BioXcel Therapeutics Reports First Quarter 2022 Financial Results and Recent Operational Highlights

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Received FDA approval of IGALMI™ (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults

Top-line data readout in Q4 2022/early Q1 2023 for TRANQUILITY II Phase 3 trial evaluating BXCL501 in acute treatment of agitation associated with Alzheimer’s disease

Extended cash runway into 2025 with $260 million strategic financing for IGALMI commercial launch and clinical and regulatory milestones

U.S. national salesforce deployment to commence on May 23, 2022

To host conference call today, May 9, 2022, at 8:30 a.m. ET

NEW HAVEN, Conn., May 09, 2022 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced its financial results for the first quarter ended March 31, 2022 and provided an update on key strategic initiatives.

“2022 has already been a transformative year during which we have made monumental progress on our journey to become the leading AI-enabled neuroscience company. Our recent achievements across our clinical, business, and commercial priorities, highlighted by our first FDA approval of IGALMI, have positioned us to realize our 2022 goals and beyond,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “Building on this momentum, we are excited to launch IGALMI, advance our proven technology, and continue delivering innovative medicines to patients and caregivers.”

Company Highlights

Neuroscience Franchise

IGALMI™ Approval and Commercial Launch

IGALMI was approved by the FDA on April 5, 2022 for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.1 Within these two patient populations in the U.S., up to 25 million agitation episodes occur each year.2-4

The Company is focused on the following key commercial launch activities to provide access to patients and caregivers:

  • Institutional Sales Force: Seasoned sales specialists were onboarded, undergoing training, and will be deployed for launch. The team has an average of over 21 years of industry experience, 14 years in hospital settings, and 8 product launches.
    • Launch meeting to be held in mid-May in preparation for national salesforce deployment on May 23rd across priority regions and customers.
  • Market Access Team: Currently engaging with group purchasing organizations (GPOs) and high value Integrated Delivery Networks (IDNs).
  • Trade Launch: Product load into distribution channels in Q3 2022.

Clinical Pipeline

BXCL501, a proprietary, sublingual film formulation of dexmedetomidine, is being investigated in multiple neuropsychiatric conditions. BXCL501 has received Breakthrough Therapy and Fast Track designation for the acute treatment of agitation associated with dementia.

Indication Expansion

  • Alzheimer’s Disease-related Agitation: TRANQUILITY program designed to maximize BXCL501 opportunity to treat Alzheimer’s Disease-related agitation. There are an estimated 100 million agitation episodes in Alzheimer’s patients occurring in the U.S. annually.5
    • TRANQUILITY II: First patient dosed; top-line data readout in Q4 2022/early Q1 2023.
    • TRANQUILITY III: Trial underway with enrollment initiating in 2H 2022.
    • Selection of 40 mcg and 60 mcg dosing regimens in pivotal trial supported by breakthrough designation from the FDA, along with positive efficacy, safety, and tolerability data observed in 100 patients in the Phase 1b/2 TRANQUILITY trial and a recent study of BXCL501 40 mcg.
  • Adjunctive Treatment for Major Depressive Disorder (MDD): Initiated Phase 1 multiple ascending dose trial in healthy volunteers.

Geographic Expansion

  • Marketing Authorization Application: Submission to the European Medicines Agency (EMA) for BXCL501 for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults in 2Q 2022.
  • Japan Entry: Company exploring market entry strategies to expand access of IGALMI to patients in Japan.

OnkosXcel Therapeutics

Established OnkosXcel Therapeutics as a wholly owned subsidiary to focus on the sustained expansion and optimization of the Company’s immuno-oncology (I-O) franchise, including its most advanced I-O program, BXCL701. BXCL701 is an investigational, orally administered, systemic innate immune activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors.

  • Metastatic Castration-Resistant Prostate Cancer (mCRPC) Program: Following positive Phase 2 data for BXCL701 in combination with KEYTRUDA® (pembrolizumab) announced this past February, continued ongoing Phase 2 trial in mCRPC patients with either small cell neuroendocrine carcinoma (SCNC) or adenocarcinoma phenotype.
    • Expect to complete enrollment of 28-patient SCNC cohort in 2H 2022.
    • First patient enrolled in adenocarcinoma randomized trial expansion evaluating BXCL701 monotherapy vs. BXCL701-KEYTRUDA combination therapy.
  • Solid Tumors Program (Checkpoint Naïve and Refractory): Additional efficacy data from MD Anderson-led open-label Phase 2 basket trial of BXCL701 and KEYTRUDA is expected in 2H 2022.

Strategic Financing

  • Announced $260 Million Strategic Financing with Oaktree and Qatar Investment Authority: Full execution of this financing would extend the Company’s cash runway into 2025 to support the commercial launch of IGALMI and achieve key clinical and regulatory milestones.

First Quarter 2022 Financial Results

Research and Development Expenses:   Research and development expenses were $18.6 million for the first quarter of 2022, compared to $14.7 million for the same period in 2021. The increased expenses were primarily attributable to clinical trial costs related to the Company’s TRANQUILITY program.

General and Administrative Expenses: General and administrative expenses were $12.9 million for the first quarter of 2022, as compared to $11.6 million for the same period in 2021. The increase was primarily due to personnel and costs related to the commercial launch readiness efforts for IGALMI in the U.S.

Net Loss: BioXcel Therapeutics reported a net loss of $31.5 million for the first quarter of 2022, compared to a net loss of $26.4 million for the same period in 2021.

As of March 31, 2022, cash and cash equivalents totaled approximately $200 million. This excludes contributions from the $260 million strategic financing announced in April. To date the Company has drawn $70M of the loan agreement and has met the milestone to receive $30M of the royalty financing which is expected to be drawn in the second quarter of 2022.

Conference Call

BioXcel Therapeutics will host a conference call and webcast May 9, 2022, at 8:30 a.m., ET, to discuss its first quarter 2022 financial results and provide an update on recent operational highlights. To access the call, please dial 877-407-5795 (domestic) and 201-689-8722 (international). A live webcast of the call will be available on the Investors section of the BioXcel website, www.bioxceltherapeutics.com, and a replay of the call will be available through August 9, 2022. 

BioXcel Therapeutics may use its website as a distribution channel of material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investors sections of its website at www.bioxceltherapeutics.com. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the “Email Alerts” option under the News/Events menu of the Investors & Media section of its website. 

About TRANQUILITY II and III
Initiated in December of 2021, TRANQUILITY II and III are pivotal Phase 3 trials evaluating BXCL501 for the acute treatment of agitation in patients with Alzheimer’s disease. The trials expand the evaluation of patients who experience agitation across diverse medical settings and across the range of dementia severity. TRANQUILITY II and III are designed to maximize the opportunity of BXCL501 for the treatment of the full spectrum of agitation associated with AD. Each trial will enroll approximately 150 dementia patients 65 years and older who will self-administer 40 mcg or 60 mcg of BXCL501 or placebo whenever agitation episodes occur over a three-month period. TRANQUILITY II will assess patients in assisted living or residential facilities requiring minimal assistance with activities of daily living. TRANQUILITY III will assess patients residing in nursing homes with moderate to severe dementia and require moderate or greater assistance with activities of daily living. The studies will assess agitation as measured by the changes from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) and Pittsburgh Agitation Scale (PAS) total scores. The primary efficacy endpoint for both studies is change in PEC score from baseline measured at two hours after the initial dose and subsequent doses.

About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. is a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. The Company’s commercial product, IGALMI™ (developed as BXCL501) is a proprietary, sublingual film formulation of dexmedetomidine approved by the FDA for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The safety and effectiveness of IGALMI has not been established beyond 24 hours from the first dose. BXCL501 is also being evaluated for the acute treatment of agitation associated with Alzheimer’s disease, and as an adjunctive treatment for major depressive disorder. The Company is also developing BXCL502 as a potential therapy for chronic agitation in dementia and, under its subsidiary OnkosXcel Therapeutics, BXCL701, an investigational, orally administered, systemic innate immunity activator for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. For more information, please visit www.bioxceltherapeutics.com.

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to the commercialization and medical affairs plans for IGALMI, timing and data from clinical trials for BXCL501 and BXCL701, the timing of the Company’s MAA application for BXCL501, and future financial and operational results. When used herein, words including “anticipate,” “will,” “plan,” “may,” “continue,” “intend,” “designed,” “goal” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its limited experience in drug discovery and drug development; its dependence on the success and commercialization of IGALMI™, BXCL501, BXCL502 and BXCL701 and other product candidates; the Company has no experience in marketing and selling drug products; IGALMI™ or the Company’s product candidates may not be accepted by physicians or the medical community in general; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by the Company’s product candidates; its novel approach to the discovery and development of product candidates based on EvolverAI; its exposure to patent infringement lawsuits; its ability to comply with the extensive regulations applicable to it; impacts from the COVID-19 pandemic; its ability to commercialize its product candidates; and the other important factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, as such factors may be updated from time to time in its other filings with the SEC which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

Contact Information

Corporate

BioXcel Therapeutics
Erik Kopp
1.203.494.7062
[email protected]

Investor Relations

FTI Consulting
Matt Ventimiglia
1.212.850.5624
[email protected]

Media

FTI Consulting
Helen O’Gorman
1.718.408.0800
[email protected]

Source: BioXcel Therapeutics, Inc.

References

  1. IGALMI™ (dexmedetomidine) [package insert]. New Haven, CT: BioXcel Therapeutics, Inc.; 2022.
  2. Wu EQ, Shi L, Birnbaum H, et al. Annual prevalence of diagnosed schizophrenia in the USA: a claims data analysis approach. Psychol Med. 2006;36(11):1535-1540.
  3. National Institute of Mental Health. Bipolar Disorder. Accessed April 5, 2022. https://rb.gy/lqz4rn
  4. UN Population Prospectus. Retrieved May 6, 2021. https://population.un.org/wpp.
  5. Tractenberg, R Neuropsychiatry Clin Neuroscience 14:1 Winter 2002
BioXcel Therapeutics, Inc.          
           
Statements of operations          
(Unaudited, in thousands, except per share amounts)          
           
  Three months ended March 31, 
    2022          2021  
           
Revenues $     $ $  
           
Operating expenses          
  Research and development $ 18,559     $   14,741  
  General and administrative   12,921         11,638  
    Total operating expenses $ 31,480     $   26,379  
Loss from operations $ (31,480 )   $   (26,379 )
Other income (expense)          
  Interest income, net   8         3  
Net loss and comprehensive loss $ (31,472 )   $   (26,376 )
           
Net loss per share – basic and diluted $ (1.12 )   $   (1.08 )
Weighted average shares outstanding – basic and diluted   27,980         24,524  
           
           
Condensed Balance Sheets          
(Unaudited, in thousands)          
           
    March 31, 2022     December 31, 2021
           
Cash and cash equivalents $ 200,435     $   232,968  
Working capital $ 191,565     $   220,145  
Total assets $ 211,045     $   239,439  
Long-term liabilities $ 1,028     $   1,105  
Total liabilities $ 17,025     $   17,772  
Total stockholders’ equity $ 194,020     $   221,667  

 

 

 

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Artificial Intelligence

XtalPi Unveils XtalGazer: A Comprehensive AI-Driven Polymorph Selection Platform

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CAMBRIDGE, Mass., March 28, 2024 /PRNewswire/ — XtalPi Inc., a leading global technology company in integrating artificial intelligence (AI) and robotics to advance the discovery of groundbreaking medicine and innovative materials, announced today the launch of its proprietary comprehensive solid form discovery and selection platform, XtalGazer. This advanced platform aims to significantly improve the polymorph selection process for the pharmaceutical industry by integrating AI- and automation-powered experimental and computational approaches.

XtalGazer provides a total solution for delivering high-quality polymorph screening and selection methods to expedite drug development and mitigate risks. It represents a paradigm shift in solid-state research, moving from the traditional trial-and-error approach to a data-driven, design-led methodology. The platform provides an expansive suite of foundational tools to accelerate polymorph discovery, characterization, and selection process, empowering pharmaceutical companies to conduct thorough research with less active pharmaceutical ingredient (API) in shorter development cycles.
A key component of XtalGazer is XtalCSP, a crystal structure prediction platform to perform global searches of crystal structures for target molecules and the other optional components in the corresponding searching space, offering a deep insight into possible stable forms. Furthermore, crystallization strategy recommendations will provide AI-backed experimental design to help avoid human bias. XtalGazer also utilizes MicroED to rapidly elucidate crystal structures from powder samples, reducing the need for growing single crystals.
XtalPi’s launch of XtalGazer marks another significant step in the company’s ongoing exploration of solid-state research. From crystal structure prediction platforms being one of the first products to launch at XtalPi, to today’s comprehensive polymorph selection platform, XtalPi will keep fulfilling its promise to solving challenging problems in this space. XtalPi will continue to deliver faster, more accurate, and more comprehensive approaches to building an ecosystem for the R&D process in solid-state, pre-formulation and crystallization.
For more information about XtalPi, please visit www.xtalpi.com.
About XtalPi:
XtalPi is an innovative technology company powered by artificial intelligence (AI) and robotics. Founded in 2015 on the MIT campus, XtalPi is dedicated to driving intelligent and digital transformation in the life science and new materials industries. With tightly interwoven quantum physics, AI, cloud computing, and large-scale clusters of robotic workstations, XtalPi offers a range of technology solutions, services, and products to accelerate and empower innovation for biopharmaceutical and new materials companies worldwide.
Media Contact: Vivienne [email protected]
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ICIS and Base Oil News Announce Partnership to Enhance Market Insights

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LONDON, March 28, 2024 /PRNewswire/ — ICIS, a global source of commodity intelligence, is pleased to announce a strategic partnership with Base Oil News, a premier news outlet founded by industry expert Iain Pocock that provides in-depth coverage of the base oils and lubricants market. This collaboration marks a significant milestone in the dissemination and exchange of critical market data and insights.

With more than two decades of journalism experience at Bloomberg, Reuters, and Argus Media, Iain Pocock brings unparalleled expertise to this partnership. His deep understanding of illiquid energy markets makes him a credible and influential figure in the industry. Since November 2023, Iain has been working closely with ICIS to share and exchange valuable data and insights, enhancing the services both platforms offer to the base oils and lubricants market.
Through the collaboration, Iain integrates ICIS’ extensive content and data resources in Base Oil News market coverage. In return, he contributes market insights to ICIS News, including expert and exclusive analysis of supply and demand dynamics, price margins, and other critical market drivers. This exchange ensures that subscribers of both ICIS and Base Oil News have access to the most comprehensive, timely, and accurate market information, empowering them to make informed decisions.
“It’s a very exciting partnership – where we leverage each other’s strengths and provide actionable insights to our customers,” said Iain Pocock, Founder of Base Oil News. “The market is the winner.”
“As ICIS is already the world’s most trusted pricing benchmark for base oils, this collaboration with Iain Pocock and Base Oil News provides an even stronger and deeper service to our customers,” said Stephen Burns, Editorial Director at ICIS. “Iain’s expertise and extensive industry connections are invaluable, and we have established a fruitful partnership that benefits the market at large.”
For the latest insights from Iain Pocock on ICIS News, visit ICIS News.  
About ICIS
ICIS – Independent Commodity Intelligence Services – helps businesses through seamlessly delivering data and analytics, across the chemical, fertilizer and energy markets. A trusted source and benchmark for price information and insight across key commodities markets worldwide. Our independent, transparent market intelligence informs thousands of quality decisions every day, taking the pressure out of negotiations and giving customers space for more innovative thinking, through published datasets including price assessments, price forecasts, supply and demand fundamentals and more.
Over 150 years of shaping the world by connecting markets to optimise the world’s valuable resources. With a global team of more than 600 experts, ICIS has employees based in London, New York, Houston, Karlsruhe, Milan, Mumbai, Singapore, Guangzhou, Beijing, Shanghai, Dubai, Sao Paulo, Seoul, Tokyo and Perth.
ICIS is part of RELX, a FTSE15 company with a market cap of £64bn and an employee base of over 30,000 experts across 40 countries.
About RELX
RELX is a global provider of information and analytics for professional and business customers across industries. The Group serves customers in more than 180 countries and has offices in about 40 countries. It employs approximately 30,000 people of whom almost half are in North America. RELX PLC is a London listed holding company which owns 52.9% of RELX Group. RELX NV is an Amsterdam listed holding company which owns 47.1% of RELX Group. The shares are traded on the London, Amsterdam and New York Stock Exchanges using the following ticker symbols: London: REL; Amsterdam: REN; New York: RELX and RENX. Total market capitalisation is approximately £64bn | €75bn | $81bn.
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Trianz Welcomes Israel Abraham as Vice President of Services for Extrica.ai – The Data to AI Platform

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SANTA CLARA, Calif., March 28, 2024 /PRNewswire/ — Digital transformation technology & services company Trianz is pleased to announce the appointment of Israel Abraham as Vice President of Extrica Platform Services.

Trianz has embarked on a transformative journey, redefining its value proposition with an ‘IP Led’ model, with a commitment to deliver the fastest time to value, lowest human dependence, and highest ROI. Central to this approach are our hyper-automated platforms, Concierto.Cloud, Extrica.AI, and Pulse, driving industry-leading transformations in cloud, data and analytics, AI, and the digital workplace.
Israel Abraham is a very well-known pioneer and industry leader in AI, data management, and analytics systems, with over three decades of experience. He joins as the services leader for Extrica- the Trianz Data to AI platform, which productizes data, provides data a face and purpose, and accelerates time to insights and AI by 50% or more. In the role of Extrica Services leader, Israel will lead the shaping, visioning, and delivery of Extrica.ai based enterprise wide datamesh, BI, and AI solutions for customers worldwide.
“We are thrilled to welcome Israel Abraham to the Trianz family,” said Sri Manchala, CEO of Trianz and author of Crossing the Digital Faultline. “He is a leader in modernization as well as conceptualization of data platforms anew. Israel’s prior background in the industry with financial services and insurance giants underscores our commitment to securing top-tier talent that brings real-world experiences and needs to our technology platforms. As we continue to broaden our footprint in the digital transformation space, Israel’s visionary leadership and practical experience will serve as the cornerstone in accelerating insights and AI to deliver transformative value to our clients.”
Having played pivotal roles in highly reputed and large organizations such as Liberty Mutual Insurance, MassMutual, Safeco, and CNA Insurance, Israel has garnered recognition as a seasoned leader in big data and AI cloud implementations. His accolades include the prestigious 2014 Ventana Research IT Innovation Award, the 2009 Informatica MDM Innovation Award, and three filed Data Engineering patents in the last four years.
“Trianz has been at the forefront of digital innovation, and Extrica.ai is a paradigm shifting data to AI platform that completely changes how analytics and AI are delivered- much faster, taking business ahead of change. I am excited to scale the adoption of the Extrica platform, which has attracted attention from giants across the industry and hyperscalers,” said Israel Abraham. “I look forward to engaging with customers, bringing my own experiences, and collaborating with the talented team at Trianz to further enhance the capabilities of the Extrica Platform Services to transform data & AI strategies, execution, and outcomes for customers.”
About Trianz
Trianz is a leading-edge technology platforms and services company that accelerates digital transformations at Fortune 100 and emerging companies worldwide in data & analytics, digital experiences, cloud infrastructure, and security. Our ‘IP Led Transformations’ approach, informed by insights from a recent global study spanning 20+ industries and 5000+ companies, addresses challenges posed by the rapid pace of AI-driven transformation, digital talent scarcity, and economic uncertainty. Our IP and platforms, including Concierto, Extrica, and Pulse, revolutionize cloud adoption, data analytics, and AI insights, empowering organizations to navigate the complexities of digital transformation seamlessly.
Founded in California and with an organization of over 2,000 associates across the United States and India, Trianz is a Premier Partner of AWS, consistently rated #1 by clients for value delivery over the past five years. Trianz has been ranked as one of the best Consulting Firms by Forbes and has been certified as a Great Place to Work for three years in a row. To learn more about Trianz, email [email protected] or visit www.trianz.com.
Watch Trianz CEO Sri Manchala’s insightful interview with Bloomberg on Partner | Crossing The Digital Faultline & Leading Towards Transformative Success – YouTube and delve deeper into his book Crossing the Digital Faultline at Crossing the Digital Faultline | Trianz.
Trianz Media [email protected] +1-408-387-5800
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