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BioXcel Therapeutics Announces $260 Million Strategic Financing with Oaktree and Qatar Investment Authority

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Investment will support upcoming U.S. commercial launch activities of IGALMI™ and further clinical pipeline development

Extends Company’s cash runway into 2025

NEW HAVEN, Conn., April 19, 2022 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (Nasdaq: BTAI) (the “Company” or “BioXcel Therapeutics”), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced strategic financing agreements with funds managed by Oaktree Capital Management, L.P. (“Oaktree”) and Qatar Investment Authority (“QIA”). Under the agreements, Oaktree and QIA will provide up to $260 million in gross funding to support the Company’s commercial activities of IGALMI™ (dexmedetomidine) sublingual film. In addition, the financing is intended to support the expansion of clinical development efforts of BXCL501, which includes a pivotal Phase 3 program for the acute treatment of agitation in patients with Alzheimer’s Disease (AD), and for the Company’s additional neuroscience and immuno-oncology clinical programs.

The long-term strategic financing process was led by Oaktree and is comprised of the following components:

  • Credit Agreement: Up to $135 million in a delayed draw term loan1
  • Revenue Interest Financing Agreement: Up to $120 million in a capped revenue interest on net sales of IGALMI and any other future BXCL501 products
  • Equity Investment: Up to $5 million purchase of BioXcel Therapeutics common stock

Under the agreement, BioXcel Therapeutics will receive $100 million in the first tranches of the strategic financing following approval by the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) in respect of the use of the Company’s BXCL501 product for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. This condition was satisfied on April 5, 2022 with the FDA’s approval of IGALMI.

Key features of the financing include a credit facility with an interest-only period lasting through the duration of the facility of five years, which can be extended for an additional year at the Company’s option upon approval of BXCL501 by the FDA for the acute treatment of agitation associated with Alzheimer’s Disease. The credit facility includes substantial flexibility for future business development and monetization events, including BXCL701, the Company’s investigational, oral innate immunity activator. Under the terms of the revenue interest financing agreement, Oaktree and QIA will receive tiered revenue interest financing payments on U.S. net sales of IGALMI and any other future BXCL501 products up to a capped return. The revenue interest financing rate ranges from 0.375% to 7.750% of annual net sales of IGALMI and any other future BXCL501 products in the U.S. The total revenue interest financing payable by BioXcel Therapeutics to Oaktree and QIA has a cap at 1.75x of the amount funded, with the ability to redeem the revenue interest financing agreement at lower multiples within the first three years from funding. The strategic financing also includes a potential equity investment of up to $5 million for shares of the Company’s common stock, to be made at the option of Oaktree and QIA, while the credit agreement is outstanding at a price per share equal to a 10% premium over the stock’s 30-day volume weighted average price leading up to the exercise by Oaktree and/or QIA of such option.

Upon closing of this transaction, and together with the Company’s cash balance and anticipated business plan, BioXcel Therapeutics is expected to have a substantial multi-year working capital runway. Full execution of this financing would result in cash runway into 2025 for the Company.

“Following our recent approval of IGALMI and today’s financing announcement, we have never been in a better position to realize our vision of becoming the leading AI-enabled neuroscience company,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “We are pleased to have strengthened our cash position with primarily non-dilutive capital as we prepare to launch IGALMI and progress our three-pillar portfolio growth strategy for this franchise, which includes pursuing additional indications, extending our geographical reach, and expanding the medical settings where IGALMI is offered. In parallel, we remain committed to advancing our additional neuroscience and immuno-oncology portfolio, including BXCL502 and BXCL701.”

“We are delighted to partner with BioXcel Therapeutics during this upcoming period of anticipated growth, highlighted by the recent approval and anticipated commercial launch of IGALMI as an acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults,” said Aman Kumar, Co-Portfolio Manager of Life Sciences Lending at Oaktree. “The Company has an exciting, AI-driven approach to drug discovery and development, and we look forward to funding the expansion of these efforts and assisting the Company in bringing new, innovative therapies to patients worldwide.”

Further information with respect to the strategic financing is set forth in a Form 8-K to be filed by BioXcel Therapeutics with the Securities and Exchange Commission (SEC).

About IGALMI™ (dexmedetomidine) Sublingual Film

IGALMI (dexmedetomidine) sublingual film, previously known as BXCL501, is a proprietary, orally dissolving film formulation of dexmedetomidine indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults under supervision by a healthcare provider. The safety and effectiveness of IGALMI has not been established beyond 24 hours from the first dose. The April 5, 2022 U.S. Food and Drug Administration (FDA) approval of IGALMI is based on data from two pivotal randomized, double-blinded, placebo-controlled, parallel group Phase 3 trials evaluating IGALMI for the acute treatment of agitation associated with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II).

About BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc. is a 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. BXCL501 is also being evaluated for the acute treatment of 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 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.

Advisors

BofA Securities acted as sole structuring advisor to BioXcel Therapeutics and Cooley LLP served as legal counsel to BioXcel Therapeutics. Sullivan & Cromwell LLP served as legal counsel to Oaktree and Shearman & Sterling LLP served as legal counsel to QIA.

About Oaktree

Oaktree is a leader among global investment managers specializing in alternative investments, with $166 billion in assets under management as of December 31, 2021. The firm emphasizes an opportunistic, value-oriented and risk-controlled approach to investments in credit, private equity, real assets and listed equities. The firm has over 1,000 employees and offices in 20 cities worldwide. For additional information, please visit Oaktree’s website at http://www.oaktreecapital.com/.

About QIA

Qatar Investment Authority (“QIA”) is the sovereign wealth fund of the State of Qatar. QIA was founded in 2005 to invest and manage the state reserve funds. QIA is among the largest and most active sovereign wealth funds globally. QIA invests across a wide range of asset classes and regions as well as in partnership with leading institutions around the world to build a global and diversified investment portfolio with a long-term perspective that can deliver sustainable returns and contribute to the prosperity of the State of Qatar. For more information on QIA, visit its website at www.qia.qa.

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 timing of the U.S. commercial launch of IGALMI for the acute treatment of agitation in schizophrenia and bipolar disorder patients; clinical development plans, including the Company’s ongoing development of BXCL501 for the treatment of agitation in dementia patients and as an adjunctive treatment for major depressive disorder; the Company’s future growth plans; expected financing under the agreements with Oaktree and QIA and the Company’s estimated cash runway and the expected sufficiency of the Company’s capital resources. When used herein, words including “anticipate,” “will,” “plan,” “potential,” “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: the Company’s need for substantial additional funding and ability to raise capital when needed; the regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, expensive and inherently unpredictable; the Company has limited experience in drug discovery and drug development; regulatory agencies, may not accept or agree with the Company’s assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and the Company in general; the Company has no experience in marketing and selling drug products and has not entered into arrangements for the sale and marketing of IGALMI or BXCL501; IGALMI or the Company’s other product candidates may not be accepted by physicians or the medical community in general; the Company may not be able to obtain marketing approvals for BXCL501 in Europe or other jurisdictions; the Company may need substantial additional funding to develop and conduct clinical trials with respect to its product candidates and support its operations; the Company must comply with extensive regulations applicable to it; and healthcare reform could adversely impact future commercial success. These and other important factors are discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2021, 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.

1 Financing also includes warrants to purchase shares of common stock of the Company and warrants to purchase LLC units in a subsidiary of the Company, as more fully described in the Current Report on Form 8-K to be filed on April 19, 2022.

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Artificial Intelligence

Brainomix Achieves Breakthrough with FDA Clearance of e-Lung AI Software

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Established market leader in stroke AI imaging receives its first FDA clearance in the lung imaging space.With this expanded foundation of AI-driven healthcare solutions, the Oxford-based company remains committed to driving innovation and delivering impactful advancements in imaging biomarkers.OXFORD, England, and CHICAGO, May 17, 2024 /PRNewswire/ — Brainomix, a pioneer in artificial intelligence (AI) imaging solutions to enable precision medicine, is proud to announce the FDA clearance of its latest product, Brainomix 360 e-Lung. Brainomix’s entry into the lung imaging space follows a series of successful clearances and widespread clinical adoption of its Brainomix 360 Stroke platform in both the US and Europe.

The clearance of e-Lung marks a significant milestone in Brainomix’s journey to expand its footprint in medical imaging beyond stroke-related applications and represents a notable step forward in the quest for advanced lung imaging solutions. The company, with its rich academic heritage and record of scientific excellence, will expand its research collaborations in the pulmonology space to yield new insights to inform future iterations of e-Lung and chart a path towards continual improvements for the lung imaging technology.
Dr Deji Adegunsoye, Assistant Professor of Medicine and Scientific Director of the Interstitial Lung Disease Program at University of Chicago Medicine, said: “This is an exciting step for Brainomix, who have a demonstrated track record of developing novel AI-based solutions in stroke and are now applying that expertise to develop innovative tools in the lung space. The preliminary data for e-Lung is impressive and would indicate that we have a promising tool that could help to expedite healthcare delivery and improve clinically meaningful outcomes for patients with lung disease.”
Brainomix recently announced the publication of a new study1 in the prestigious peer-reviewed journal American Journal of Respiratory and Critical Care Medicine (AJRCCM), resulting from a research collaboration with AstraZeneca. The results showed that Brainomix’s proprietary lung imaging biomarkers, which include the weighted reticulovascular score (WRVS), stratified patients at risk of Idiopathic Pulmonary Fibrosis (IPF) progression, outperforming standard measures.
Dr Michalis Papadakis, CEO and Co-Founder of Brainomix, said: “We are harnessing our expertise in AI-powered imaging to develop novel biomarkers in other disease indications where AI can support imaging-based diagnostic and treatment decisions.
“This e-Lung FDA clearance reflects our focus on developing innovative solutions that empower healthcare professionals with cutting-edge tools for sophisticated disease evaluation, enhancing access to treatments that can ultimately work to improve patient outcomes.”
Brainomix will be presenting its latest e-Lung data at the American Thoracic Society (ATS) annual conference in San Diego May 17th – 22nd, including results from research collaborations with Heidelberg University and with Seattle-based Avalyn Pharma.
Am. J. Respir. Crit. Care Med.: 2024 Feb 16 – e-Lung CT Biomarker Stratifies Patients at Risk of IPF Progression in a 52-Week Clinical Trialhttps://www.atsjournals.org/doi/abs/10.1164/rccm.202312-2274LEAbout Brainomix
Brainomix specializes in the creation of AI-powered software solutions to enable precision medicine for better treatment decisions in stroke and lung fibrosis. With origins as a spin-out from the University of Oxford, Brainomix is an expanding commercial-stage company with offices in the UK, Ireland and the USA, and operations in more than 30 countries. A private company, backed by leading healthtech investors, Brainomix has innovated award-winning imaging biomarkers and software solutions that have been clinically adopted in hundreds of hospitals worldwide. Its first product, the Brainomix 360 stroke platform, provides clinicians with the most comprehensive stroke imaging solution, driving increased treatment rates and improving functional independence for patients.
To learn more about Brainomix and its technology visit www.brainomix.com, and follow us on Twitter, LinkedIn and Facebook.
Contacts
Jeff Wyrtzen, Chief Marketing & Business Development [email protected] +44 (0)7927 164210T +44 (0)1865 582730
Media enquiries
Charles ConsultantsSue [email protected] M +44 (0)7968 726585
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CUBE acquires global regulatory intelligence businesses from Thomson Reuters

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LONDON, May 17, 2024 /PRNewswire/ — CUBE, a global leader in Automated Regulatory Intelligence (ARI) and Regulatory Change Management (RCM), announces today its acquisition of the Thomson Reuters Regulatory Intelligence and Oden products and businesses.

The acquisition of these global businesses represents a major step forward in CUBE’s growth plans. It will deliver significant scale across many of the world’s leading and systemically important financial institutions. CUBE’s existing global customer base will be expanded to total approximately 1,000 customers in banking, insurance, asset and investment management, payments and adjacent regulated industries.
CUBE’s global employees will expand to 600, of which close to 250 are highly qualified regulatory subject matter experts, legal and compliance professionals.
Ben Richmond, founder and CEO of CUBE said: “Thomson Reuters is known to be the biggest and best in the industry for providing regulatory expert analysis and subject matter expertise, alongside world-leading journalism and news. The combination of CUBE’s purpose-built AI, with the years of content curated by Thomson Reuters Regulatory Intelligence and Oden expert analysts, will accelerate innovation. Together, we will deliver regulatory transformation capabilities for our global customers that could only have been imagined before.”
Richmond continues: “This combination will provide tremendous scale and depth across CUBE’s regulatory content and technology. It is a significant step toward creating an industry-defining regulatory compliance and risk platform that will benefit all customers and elevate the industry as a whole.”
Through this acquisition, CUBE will provide an expanded and comprehensive selection of specialized regulatory intelligence and regulatory change services, committed to excellence, quality, and highly contextualised and meaningful regulatory content for customers. By combining cutting-edge technology and subject matter expertise at scale CUBE will set a new bar for the industry in regulatory automation and content.
Chris Maguire, General Manager, Risk and Fraud, Corporates, Thomson Reuters said: “It was clear to us that CUBE had established itself as a leading regulatory intelligence provider for global enterprise clients in the financial services and insurance sectors. We wanted to ensure our customers and employees could work with an organisation that would continue to innovate and significantly invest in solutions like Thomson Reuters Regulatory Intelligence and Oden. We are working tirelessly to ensure a seamless and value-enhancing transition for customers and employees, and we are looking forward to working with the CUBE team during this transition.” 
Christopher Fielding, Hg, said: “We’re delighted to further extend our market reach, bringing in two high quality and complementary global businesses to the CUBE platform.”
Thomas Martin, Hg, added: “We see these acquisitions as enabling further innovation in the regulatory intelligence and change management sector, leading to strengthened demand for these quality solutions across the globe.”
The terms of the transaction will not be disclosed.
About CUBE
CUBE provides a highly comprehensive and robust source of classified, and meaningful AI-driven regulatory data to power its Automated Regulatory Intelligence (ARI) and Regulatory Change Management (RCM) solutions. CUBE’s purpose-built regulatory technology including its AI engine (RegBrain) and software platform (RegPlatform) tracks, analyses, and monitors laws, rules, and regulations in every country and in every published language to create an always up-to-date regulatory footprint that transforms visibility and compliance capability for customers across the globe.
With operations across Europe, North America, Canada, Asia, and Australia, CUBE serves a diverse and global base of customers and partners including the largest financial institutions in the world who leverage CUBE’s platform to streamline their complex regulatory intelligence and change management processes.
Following the strategic partnership with Hg in March 2024, CUBE announced the acquisition of US-based Reg-Room in May 2024.
About Hg
Hg supports the building of sector-leading enterprises that supply businesses with critical software applications or workflow services, delivering a more automated workplace for their customers.
This industry is characterised by digitisation trends that are in early stages of adoption and are set to transform the workplace for professionals over decades to come. Hg’s support combines deep end-market knowledge with world class operational resources, together providing compelling support to entrepreneurial leaders looking to scale their business – businesses that are well invested, enduring and serve their customers well.
With a vast European network and strong presence across North America, Hg’s 400 employees and around $70 billion in funds under management support a portfolio of around 50 businesses, worth over $140 billion aggregate enterprise value, with over 110,000 employees, consistently growing revenues at more than 20%.
About Regulatory Intelligence
Regulatory Intelligence is a proactive, connected, and comprehensive solution that tracks and analyses regulatory changes within ~2,000 regulatory bodies and rulebooks for more than 20 countries. It enables banking, financial services, and insurance (BFSI) sectors to manage exposure to operational, regulatory, and compliance risk.
About Oden
Oden State Rules and Regulations (SR&R), Oden Policy Terminator/Sentry PT, and OdenTrack provide repositories and automated solutions for complying with state rules and regulations on the provisioning of Personal and Business Insurance in the US.

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Cayman Enterprise City Publishes Socio-Economic Impact Assessment by Economist and Leading Advisor on the Caribbean, Marla Dukharan

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The Impact of Cayman Enterprise City’s Socio-Economic Development Project Nears USD $1 Billion
GRAND CAYMAN, Cayman Islands, May 16, 2024 /PRNewswire/ — Cayman Enterprise City (CEC) has released a Socio-Economic Impact Assessment by Marla Dukharan. The report illustrates that CEC is increasing its impact by supporting higher earnings for Caymanians and is driving a shift towards a knowledge-based economy by focusing on high productivity sectors. The release by Dukharan reads, “Caymanian resourcefulness and private sector-led innovation have been the driving force behind the islands’ outstanding socio-economic success. Cayman Enterprise City underpins the next generation of Cayman innovation and dynamism.”

With an economic impact of USD $130 million in 2023, contributing just under USD $1 billion to the local economic activity in 12 years since inception, “CEC is helping the nation to diversify economically, in terms of sectors and jobs, ensuring locals have economic and employment opportunities that match the nation’s progress,” the report reads.
The CEC socio-economic development project is now home to 352 Special Economic Zones Companies (SEZCos), many of which are globally recognised institutions led by top executives and industry experts. “CEC member companies are providing high-value employment with salaries exceeding those typically found outside of the special economic zone,” said Charlie Kirkconnell, Chief Executive Officer at CEC. “The CEC community is fully invested in Cayman and the report illustrates that the CEC socio-economic development project is making a very significant impact on Cayman’s economy and community.”
“As CEC continues to grow, it continues to create significant employment and entrepreneurial opportunities for Caymanians and we encourage anyone that might be interested in finding out how they might get involved, whether as a member of the community and/or as a volunteer in our Enterprise Cayman non-profit organisation (NPO).”
77% of Caymanian-held jobs at CEC member companies, are in sectors with high social returns and increasing global demand. “By putting skills first and prioritizing learning, CEC is enabling new industries to take root,” the release by Dukharan reads.
CEC, through its Enterprise Cayman NPO, is a first-mover in private sector-facilitated education and training in the Caribbean, making it a leading force to boost youth participation in the economy. By offering training in specialised skills, Enterprise Cayman is helping to close the gap in higher education and earnings for Caymanians. “Through Enterprise Cayman we’ve set out to strategically support meaningful employment and entrepreneurial opportunities for Caymanians, by providing internship and mentorship opportunities, by hosting skill-building and career focused training, and by providing invaluable networking and community engagement opportunities,” said Kirkconnell.
In 2023 individuals took advantage of 4,226 opportunities to participate in education, training, and career development events and, since launching entrepreneurial programming in 2021, Enterprise Cayman has worked with 41 new Cayman-born business ventures. “We’re helping to develop a local talent pool that meets the demand of Cayman’s growing digital innovation and technology sectors while, in parallel, offering exciting opportunities for individuals to launch new business ventures within an innovative business environment,” said Kirkconnell.  
With CEC’s new campus and state-of-the-art facilities, Signal House, the project “holds the promise of deep, continued economic impact,” the report concludes.
To access CEC’s economic impact assessments and Enterprise Cayman’s annual reports please visit https://www.enterprisecayman.ky/reports. For more information on how to get involved and for upcoming programmes and events visit www.enterprisecayman.ky. 
Website: www.caymanenterprisecity.com LinkedIn: @CaymanEnterpriseCityTwitter:  @CEC_CaymanInstagram: @CaymanEnterpriseCityFacebook: @CaymanEnterpriseCityYouTube: @ceccayman
About Cayman Enterprise City 
Cayman Enterprise City (CEC) is an award-winning development project which consists of three special economic zones (SEZs) focused on attracting knowledge-based and specialised-services businesses to set up a genuine physical presence in the Cayman Islands. The zones included within CEC are Cayman Tech City, Cayman Commodities & Derivatives Centre, and Cayman Maritime & Aviation City. With a dedicated Government Authority, licensing fee concessions and guaranteed fast-track processes, CEC enables international companies to quickly and efficiently establish a Cayman Islands office, which in turn enables them to generate active business income within a tax neutral environment.
About Enterprise Cayman 
Enterprise Cayman is a non-profit organisation (NPO) powered by Cayman Enterprise City in partnership with Cayman Islands’ special economic zone companies (SEZCos). The organisation, which applies the Theory of Change (TOC) methodology, provides Caymanians and residents with access to high-quality learning experiences and opportunities to develop and launch new business ventures, to pursue careers within the technology and innovation sectors, and to join a dynamic network of industry professionals. Let’s grow the next generation of Caymanian innovators and entrepreneurs with Enterprise Cayman!
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FOR MORE INFORMATION:Contact: Kaitlyn Elphinstone  Email: [email protected]  

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