Artificial Intelligence
BioXcel Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
New Drug Application (“NDA”) submitted to the U.S. Food and Drug Administration (“FDA”) for BXCL501 for the acute treatment of schizophrenia and bipolar disorder related agitation
TRANQUILITY achieved primary and secondary endpoints with both doses of BXCL501; End of Phase 2 meeting with the FDA planned for Q2 2021
RELEASE trial on track to report topline results in Q1 2021
Topline results from two ongoing trials with BXCL701 in aggressive forms of prostate cancer and advanced solid tumors are expected in mid-2021
Company to host conference call today at 8:30 a.m. ET NEW HAVEN, Conn., March 11, 2021 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced its quarterly results for the fourth quarter and full year ended December 31, 2020 and provided an update on key strategic and operational initiatives.
“Over the last 12 months, we have made significant progress with our leading neuroscience program, BXCL501, including reporting successful data readouts, submitting our first NDA, as well as advancing other potential indications,” stated Vimal Mehta, Chief Executive Officer of BioXcel. “In addition to submitting our NDA for the acute treatment of schizophrenia and bipolar disorder related agitation, we also announced positive data from the TRANQUILITY Phase 1b/2 trial in dementia related agitation and will be discussing our plans for a pivotal Phase 3 program with the FDA in the second quarter of 2021. In parallel, we continue to evaluate BXCL501’s potential in a wide range of neuropsychiatric conditions with ongoing trials in opioid withdrawal symptoms and delirium related agitation. As we develop the commercial infrastructure needed to bring this potential candidate to market, we continue to execute on our clinical and corporate milestones, as well as leverage our unique AI platform to reach new patient populations where there are large unmet medical needs.”
Dr. Mehta continued, “Moreover, our immuno-oncology candidate, BXCL701, has demonstrated encouraging signals of activity in difficult-to-treat tumors across both combination trials. We expect to report topline data from the ongoing trials in mid-2021, in hopes of further demonstrating this candidate’s potential at enhancing an individual’s innate immunity.”
Fourth Quarter and Full Year 2020 and Recent Highlights
BXCL501-Neuroscience Program BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist, designed for the treatment of agitation and opioid withdrawal symptoms. The Company believes BXCL501 may directly target a causal agitation mechanism.
Commercial Highlights
Medical Affairs Initiatives
BXCL701-Immuno-Oncology Program
BXCL701 is an orally-delivered small molecule, immunomodulator designed to inhibit dipeptidyl peptidase (DPP) 8/9 and block immune evasion by targeting Fibroblast Activation Protein (FAP). It has shown single agent anti-tumor activity in melanoma and safety has been evaluated in more than 700 healthy subjects and cancer patients.
Corporate Highlights
Fourth Quarter and Full Year 2020 Financial Results
BioXcel reported a net loss of $21.1 million for the fourth quarter of 2020, compared to a net loss of $8.3 million for the same period in 2019. For the full year, BioXcel reported a net loss of $82.2 million, compared to a net loss of $33.0 million for the same period in 2019.
For the fourth quarter of 2020, research and development expenses were $11.4 million as compared to $6.5 million for the same period in 2019. The increase was primarily attributable to increased personnel, clinical trial and professional research costs primarily related to our BXCL501 studies.
Research and development expenses were $58.0 million for the full year 2020, as compared to $25.8 million for the same period in 2019. The increase for the year ended December 31, 2020 was generally attributable to increased clinical trial costs, compensation costs and professional research costs associated with BXCL501, as the Company continues to expand its clinical programs. General and administrative expenses were $9.7 million for the fourth quarter of 2020, as compared to $1.9 million for the same period in 2019. The increase was primarily due to an increase in compensation costs related to the growth of BioXcel’s operations. Professional fees also increased primarily related to costs associated with preparation for the potential commercial launch of BXCL501.
General and administrative expenses were $24.3 million for full year 2020, as compared to $7.8 million for the same period in 2019. The increase was primarily due to the growth of BioXcel’s operations. Professional and consulting fees also increased due to the expansion of our corporate activities.
The fourth quarter 2020 results include approximately $6.6 million in non-cash stock-based compensation costs. For the full year, non-cash stock-based compensation costs totaled $14.6 million.
As of December 31, 2020, cash and cash equivalents totaled approximately $213.1 million.
Conference Call: BioXcel will host a conference call and webcast today at 8:30 a.m. ET. To access the call, please dial 877-407-2985 (domestic) and 201-378-4915 (international). A live webcast of the call will be available on the Investors sections of the BioXcel website at www.bioxceltherapeutics.com. The replay will be available through at least March 25, 2021.
About BioXcel Therapeutics, Inc.:
BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. BioXcel’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. BioXcel’s two most advanced clinical development programs are BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation and opioid withdrawal symptoms, and BXCL701, an investigational, orally administered, systemic innate immunity 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. 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 timing and data from clinical trials for BXCL501 and BXCL701, the Company’s planned commercial structure, the potential value of BXCL501 and BXCL701 as treatment options, and the outcome of the Company’s new drug application. When used herein, words including “anticipate,” “being,” “will,” “plan,” “may,” “continue,” 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 BioXcel’s current expectations and various assumptions. BioXcel believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. BioXcel 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 BXCL501 and BXCL701 and other product candidates; 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 BioXcel’s product candidates; its approach to the discovery and development of product candidates based on EvolverAI is novel and unproven; 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 Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 as will be updated by its Annual Report on Form 10-K for the year ended December 31 2020, as such factors may further be updated from time to time in its other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the Investors section of BioXcel’s website at www.bioxceltherapeutics.com.
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 BioXcel 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 BioXcel’s views as of any date subsequent to the date of this press release.
BioXcel Therapeutics, Inc.
Statement of Operations
(Unaudited, in thousands, except per share amounts) BioXcel Therapeutics, Inc.
Condensed Balance Sheet
(Unaudited, in thousands)
Contact Information:
BioXcel Therapeutics, Inc. Investor Relations:
Mary Coleman John Graziano Media: Julia Deutsch
Three Months Ended
December 31,
Year Ended
December 31,
2020
2019
2020
2019
Revenues
$
–
$
–
$
–
$
–
Operating Expenses
Research and Development
$
11,401
$
6,495
$
57,995
$
25,797
General and administrative
9,696
1,918
24,302
7,804
Total operating expenses
21,097
8,413
82,297
33,601
Loss from Operations
(21,097
)
(8,413
)
(82,297
)
(33,601
)
Other Income (expense)
Interest income, net
11
138
128
633
Net loss
$
(21,086
)
$
(8,275
)
$
(82,169
)
$
(32,968
)
Net loss per share – basic and diluted
$
(0.87
)
$
(0.45
)
$
(3.79
)
$
(2.02
)
Weighted average shares outstanding – basic and diluted
24,375
18,051
21,683
16,289
December 31,
December 31,
2020
2019
Cash and cash equivalents
213,119
32,426
Working capital
205,223
25,639
Total assets
219,936
36,392
Long-term liabilities
1,398
1,029
Total liabilities
13,240
9,497
Total stockholders’ equity
206,696
26,895
BioXcel Therapeutics, VP of Investment Relations
[email protected]
1.475.238.6837
Solebury Trout
[email protected]
1.646.378.2942
Solebury Trout
[email protected]
1.646.378.2967
Artificial Intelligence
Kazakhstan Government Delegation Visited SUPCON
HANGZHOU, China, Sept. 29, 2024 /PRNewswire/ — On September 26, a delegation from the Ministry of Digital Development, Innovations and Aerospace Industry of the Republic of Kazakhstan, led by Minister Madiyev Zhaslan, visited SUPCON. SUPCON’s Chairman and President, Mr.Cui Shan, warmly welcomed the delegation.
The Kazakhstan government representatives expressed their appreciation and recognition of SUPCON’s expertise and innovation in intelligent manufacturing, digital transformation, and industrial AI.
Madiyev Zhaslan expressed a strong interest in industrial AI technologies of SUPCON, particularly their applications in intelligent and low-carbon facilities. He looks forward to exploring extensive collaboration with SUPCON across various sectors in Kazakhstan.
Cui Shan emphasized that as a leading industrial AI company with a global presence, SUPCON will leverage its technological advantages to meet Kazakhstan’s industry development requirements and trends, injecting new momentum into the country’s industrial digitalization.
In 2023, SUPCON established a subsidiary in Kazakhstan as its Central Asia regional headquarters and set up a localized operational system. SUPCON will continue to invest in the long-term development of the Central Asia region, contributing further wisdom and strength to the industrial digital transformation in Kazakhstan and beyond.
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Artificial Intelligence
Huawei Peer-Recognized as a 2024 Gartner® Peer Insights™ Customers’ Choice for Enterprise Wired and Wireless LAN Infrastructure
SHENZHEN, China, Sept. 29, 2024 /PRNewswire/ — On September 24, 2024, Huawei announced that it has been peer-recognized a 2024 Gartner® Peer Insights™ Customers’ Choice in the Voice of the Customer for Enterprise Wired and Wireless LAN Infrastructure thanks to its Xinghe Intelligent Campus offerings. This marks the fifth year in a row that Huawei has received this distinction. Notably, Huawei receives Customers’ Choice distinctions in four of the six customer segments: Midsize Enterprise (50M – 1B USD); Public Sector, Government and Education; Asia/Pacific; and Europe, the Middle East and Africa.
As of June 30, 2024, customers across diverse sectors — including manufacturing, IT services, education, and telecommunication — have reviewed Huawei’s complete Xinghe Intelligent Campus offerings on the Gartner Peer Insights platform. We believe their impressive feedback showed global recognition of Huawei from the industry influence, deployment scales, and mature commercial use perspectives.
“We’re thrilled to be named a Gartner® Peer Insights™ Customers’ Choice for Enterprise Wired and Wireless LAN Infrastructure again,” said Shawn Zhao, President of Huawei’s Campus Network Domain. “Recently, Huawei launched the newly upgraded Xinghe Intelligent Campus that takes wireless, application, and O&M experience to new levels with AI technologies, ultimately accelerating the digital transformation of enterprises.”
Looking ahead, Huawei will further innovate Xinghe Intelligent Campus offerings from wireless, application, and O&M experience upgrade perspectives, helping all industries stride to the future of experience-centric intelligent campus networks.
For more about Gartner® Peer Insights™ Customers’ Choice, visit: https://www.gartner.com/reviews/market/enterprise-wired-wireless-lan-access-infrastructure
Disclaimer:
Gartner, Voice of the Customer for Enterprise Wired and Wireless LAN Infrastructure, Peer Contributors, 12 September 2024
Gartner, Peer Insights, Magic Quadrant and Customers’ Choice badge are trademarks of Gartner, Inc. and/or its affiliates. All rights reserved. Gartner Peer Insights content consists of the opinions of individual end users based on their own experiences, and should not be construed as statements of fact, nor do they represent the views of Gartner or its affiliates. Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.
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View original content:https://www.prnewswire.co.uk/news-releases/huawei-peer-recognized-as-a-2024-gartner-peer-insights-customers-choice-for-enterprise-wired-and-wireless-lan-infrastructure-302261856.html
Artificial Intelligence
Huawei Wen Tong: 6G Needs to Embrace AI for Shaping Future Network
SHENZHEN, China, Sept. 29, 2024 /PRNewswire/ — At the 6G Conference held in Istanbul, on September 24, 2024, Dr. Wen Tong, Huawei Wireless CTO, delivered a keynote speech on 6G standardization and innovation. With the release of the ITU-R 6G vision framework, the 3GPP will start 6G standardization in 2025. “6G is a new generation of mobile technology, not a simple upgrade of 5G, it should bring new value to users,” said Dr. Tong, “6G is a true intergenerational technological disruption. 6G standard, key technologies, and network architecture should be re-defined based on application scenarios and requirements from 2030 to 2040. 6G should not be another way to implement 5G. Instead, 6G should embrace the AI revolution with a quantum leap and generate new values for the consumers. In this way, 3GPP standards can truly realize the 6G vision and create greater value for the entire industry.”
Centered “6G Standardization Direction” and “6G Innovation Driving Force”, Dr. Tong shared important views on the future architecture, terminal development, and key technologies of 6G.
In terms of architecture design, 6G should go beyond Service-Based Architecture and move towards Application-Driven Network.
5G has already achieved market success and continues to evolve towards 5G-Advanced. 6G will not simply reuse 5G network architecture, without generational and fundamental innovations, which will limit the mobile industry’s aspiration and imagination to dive the innovation in the 6G era. 6G must have obvious cross-generational characteristics and technical breakpoint.
On the core side, reusing the 5G core network will hinder the innovation in AI. We should use Agentic-AI based technology to re-architect 6G Core that goes beyond 5G Service-Based Architecture and support the foundational capabilities of AI, Sensing and NTN , and thus evolve towards the Application Driven Network .
In terms of terminal evolution, 6G user device calls for a breakthrough to lead the success of the entire industry chain.
It is the law of the mobile industry to drive the evolution of the market with the pioneering technology. The 6G networks and 6G terminals must meet the requirements of consumers and vertical industries in the 6G market phase from 2030 to 2040.
Currently, smartphones are evolving to AI terminals to usher in the mobile AI era. In post-MBB era, breakthroughs in terminal technologies will be the key to the evolution of the mobile industry. Therefore, 6G user device calls for a breakthrough towards “Full-AI”, thus to drive 6G network upgrade and the success of the entire industry ecosystem.
In terms of technology development, AI will become a key enabler for 6G with network paradigm shifting.
Twenty years ago, the Internet was the enabler of the technology innovations. Mobile communications embraced the Internet and achieved great business success. Today, AI maybe the disruptive enabler of the latest technology innovations.
6G should embrace the AI revolution with a quantum leap. However, 6G networks should not be limited to generative AI, Artificial General Intelligence (AGI) and Embodiment-AI are the main directions of future AI development. Therefore, AGI should run through the whole process of sensing, reasoning, decision, and action of terminals, wireless networks, and core networks of 6G, to welcome the arrival of a new network paradigm.
At the end, Dr. Tong Wen emphasized the relationship between 5G and 6G: “The global 5G deployment is on the rise and evolving to 5G-Advanced, which not only meets the current requirements of operators, but also protects their investment. Therefore, 6G technologies should not overlap with 5G in technologies and market space. The specifications, technologies, and architecture of 6G must be based on the scenarios and requirements from 2030 to 2040. We should focus on true generational technology disruption, embrace the new opportunities brought by AI, expand the mobile industry in the next generation.”
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