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BioXcel Therapeutics Reports Second Quarter 2023 Financial Results and Announces Strategic Reprioritization

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Business to prioritize high-potential agitation market opportunities for BXCL501 in bipolar disorders, schizophrenia, and Alzheimer’s disease

Commercial reprioritization intended to reduce related expenses by 80% with focus on market access through contracting with large hospital systems (IDNs)

Requested meeting with FDA to discuss TRANQUILITY II, audit plan, and data package to support potential submission of sNDA for BXCL501 in patients with agitation associated with mild to moderate dementia due to probable Alzheimer’s disease

SERENITY III Phase 3 trial (part 2) protocol amendment in process to evaluate BXCL501 80 mcg dose for at-home use in bipolar disorder or schizophrenia agitation

Cash runway post-strategic reprioritization, expected through mid-2024; discussions underway with existing strategic finance partners

Company to host conference call at 8:00 a.m. ET today

NEW HAVEN, Conn., Aug. 14, 2023 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced its financial results for the second quarter ended June 30, 2023, and a strategic reprioritization to strengthen its focus and significantly reduce operating expenses.

Strategic Reprioritization and Clinical Development Initiatives
Following a comprehensive review of the business, the Company has determined to focus on high-potential agitation-market opportunities using its innovative, AI-based clinical drug development platforms. The Company intends to reduce more than 50% of its cash burn to approximately $80 million on a go-forward annualized basis. The Company will also be reducing its workforce from approximately 190 to 80 employees. These actions include a shift in commercial strategy for IGALMI™ in the institutional setting, a reduction of in-hospital commercialization expenses, a suspension of programs no longer deemed core to the Company’s business, and a shift in focus to develop BXCL501 for use in the at-home setting in the treatment of agitation in schizophrenia, bipolar disorders, and in patients with mild to moderate dementia due to probable Alzheimer’s disease.

“We are shifting our primary focus to development in the at-home setting while maintaining our value-creating core capabilities ranging from AI innovation to commercialization,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “Our AI-driven drug re-innovation approach has led to the capital-efficient development of product candidates in underserved therapeutic areas. We intend to prioritize our resources to develop BXCL501 for use in assisted living facility (ALF) and at-home settings and continue to advance our neuroscience pipeline. Unfortunately, this reprioritization requires us to reduce our workforce. We are grateful to all employees for their contributions and will support those who are impacted through their transitions.”

Strengthened Focus on At-home Market Opportunities for BXCL501

TRANQUILITY Program: Alzheimer’s Dementia Agitation

  • TRANQUILITY II: Announced positive topline results in June 2023 from a Phase 3 trial that evaluated the safety and efficacy of BXCL501 for the acute treatment of agitation in mild to moderate dementia patients with probable Alzheimer’s disease, who were 65 years and older living in ALFs and residential care settings and required minimal assistance with activities of daily living.
    • Trial met primary endpoint with the 60 mcg dose, with BXCL501 demonstrating a statistically significant 39% greater reduction in PEC score from baseline compared to placebo at 2 hours (p=0.0112).
    • Met a key secondary endpoint with statistically significant reduction (p=0.0185) in agitation symptoms versus placebo, as measured by PEC score change from baseline at 1 hour with 60 mcgdose.
    • 443 episodes for 149 patients were treated over 12 weeks across all doses; dosing with 60 mcg showed a similar reduction in agitation for first and all treated episodes at 1 and 2 hours, as measured by average change in PEC score.
    • An independent third party has been retained to initiate and perform a data integrity audit of the TRANQUILITY II clinical site where the principal investigator has engaged in misconduct.
    • Company has requested a meeting with FDA to discuss its TRANQUILITY program, including TRANQUILITY II, the data audit, TRANQUILITY III, and the data package that may be required to support submission of a supplemental New Drug Application (sNDA) seeking approval of BXCL501 for the acute treatment of agitation in mild to moderate dementia patients with probable Alzheimer’s disease in the ALF and at-home setting.
    • Specifically, the Company plans to request feedback from FDA about the sufficiency of data from its TRANQUILITY I and II clinical trials, pharmacology, and toxicology package to support a potential sNDA submission seeking approval in the ALF and/or at-home settings. The Company has not conducted a clinical trial evaluating the at-home use of BXCL501 in mild to moderate dementia patients with probable Alzheimer’s disease. However, the TRANQUILITY II trial included both ALF and residential settings. The Company seeks feedback from the FDA as to whether any additional clinical studies may be required.
    • The Company also plans to discuss TRANQUILITY III trial insights with FDA and has elected to pause additional enrollment in this Phase 3 trial in patients with agitation associated with moderate to severe dementia with probable Alzheimer’s disease in nursing homes; enrolled patients are continuing the 12-week treatment period. The initial enrolled patients were observed to have more frequent episodes of agitation than originally anticipated, suggesting that agitation may present chronically in this population. Due to the chronic nature of agitation episodes observed thus far, the Company believes that continued evaluation of BXCL501 in this population would require a different development program targeting more frequent or chronic use. The Company has chosen to focus its development efforts on the urgent need for episodic treatment in the ALF and at-home setting, consistent with the Breakthrough Therapy designation FDA has granted to BXCL501 for acute treatment of agitation associated with dementia.
    • For a further discussion of the results from and certain risks associated with the TRANQUILITY II trial, please see the Company’s Form 8-K filed with the SEC on June 29, 2023 and its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023.

SERENITY Program: Agitation Associated with Bipolar Disorders or Schizophrenia (At-Home Use)

  • SERENITY III Part 1 (completed): assessed the safety and efficacy of a 60 mcg dose of BXCL501 using the same primary and secondary endpoints as used in SERENITY I and II, which supported IGALMI’s approval, with patients in a monitored medical setting used as surrogates for the at-home setting.
    • Reported topline data in May 2023; did not meet the primary endpoint of change in PEC score from baseline at 2 hours with half (60 mcg) of the approved dose of IGALMI, but clinically meaningful efficacy results were observed, including a statistically significant change in PEC score from baseline at 4 hours, a secondary endpoint in the trial.
    • BXCL501 was well tolerated and demonstrated favorable safety results supporting potential for at- home use.
  • SERENITY III Part 2 (ongoing): underway using a 60 mcg dose with an optional second 60 mcg dose, while pharmacokinetic and pharmacodynamic modeling suggested that use of an 80 mcg dose of BXCL501 could provide an optimal balance between potential safety and efficacy for at-home use. The Company believes that evaluation of an 80 mcg dose is further supported by previous clinical experience with an 80 mcg BXCL501 dose in a Phase 1b study in schizophrenia patients with agitation. The Company believes the totality of evidence provides support for evaluating this dose in Part 2. Further, the Company plans to meet with FDA to discuss the 80 mcg dose and the elements of the proposed protocol amendment. Part 2 is primarily intended to evaluate safety of BXCL501 over 12 weeks when used as needed for episodes of agitation associated with schizophrenia and bipolar at home. The primary objective is to describe the incidence of treatment-emergent adverse events. The primary endpoint of the trial is a comparison of serious adverse events and treatment-emergent adverse events as compared to placebo, though the secondary endpoints for Part 2 include a number of efficacy assessments.

Adjunctive treatment in Major Depressive Disorder (MDD)

  • Phase 1b Multiple Ascending Dose (MAD) trial tested safety and tolerability of daily dosing of BXCL501, including in combination with duloxetine, for seven days in healthy volunteers.
    • Company reported positive topline results in May.
    • As part of its strategic reprioritization, the Company is pausing its plan to develop a Phase 2 human proof-of-concept (POC) trial design to investigate BXCL501 as an adjunctive treatment and its potential accelerant effect in combination with first-line selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors.

Neuroscience Pipeline Development

  • The Company is planning to host a neuroscience R&D Day in H2 2023, which will:
    • Highlight its neuroscience pipeline, including BXCL502
    • Showcase its next-generation AI-based drug discovery and development platform that has identified potential new product candidate concepts (BXCL503 and BXCL504).

IGALMI Commercialization
IGALMI continued to build on its momentum through the second quarter, climbing to over 185 formulary approvals and unlocking up to $80 million in market potential. There are more than 650 additional formulary reviews scheduled, representing up to an additional $275 million in bipolar and schizophrenia agitation market opportunity. Recent substantial orders through the contracting process resulted in the doubling of Q2 revenues sequentially, a process which the Company will emphasize moving forward.

  • The commercial reprioritization is designed to pivot focus to market access with contracting by existing customers and large systems (Integrated Delivery Networks or IDNs).
  • The Company plans to continue to support hospitals ordering IGALMI and those with positive formulary status through trade, distribution, and medical support. 

OnkosXcel Therapeutics Immuno-oncology Subsidiary

  • Continuing to actively evaluate strategic options for OnkosXcel Therapeutics, including potential financing or strategic partnership, M&A, or sale.

Second Quarter 2023 Financial Results

Net Revenue: Net revenue of IGALMI was approximately $457 thousand for the quarter.

Research and Development (R&D) Expenses: R&D expenses were $27.0 million for the second quarter of 2023, compared to $17.9 million for the same period in 2022. The increased expenses were primarily attributable to increased clinical trial expenses for SERENITY III and TRANQUILITY II.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $25.9 million for the second quarter of 2023, compared to $18.4 million for the same period in 2022. The increased expenses were primarily attributable to an increase in personnel and related costs to support the commercialization of IGALMI™.

Net Loss: BioXcel Therapeutics had a net loss of $53.5 million for the second quarter of 2023, compared to a net loss of $37.7 million for the same period in 2022. The loss for the quarter included approximately $6.1 million in non-cash stock-based compensation.

Cash and cash equivalents totaled $127.5 million as of June 30, 2023. As noted above, the Company is undertaking a strategic reprioritization, which includes a reduction in force of more than 50%, that is expected to reduce expenses significantly. In the absence of additional capital becoming available to the Company under the strategic financing agreements or otherwise, the Company estimates that its current cash and cash equivalents will last through mid-2024.

The Company’s previously disclosed cash runway projection assumed the full utilization of its strategic financing agreements ($155 million of potential additional availability) with Oaktree Fund Administration LLC and Qatar Investment Authority. Based on recent events, the Company is not likely to be in a position to meet the milestones required to access additional capital under the financing agreements. The Company has initiated discussions with its strategic financing partners to amend the agreements. Successful modification of these agreements could further extend the Company’s cash runway.

Conference Call
BioXcel Therapeutics will host a conference call and webcast on August 14, 2023 at 8:00 a.m. ET to discuss its second quarter 2023 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 will be available on the Investors section of the corporate website, bioxceltherapeutics.com, and a replay will be available through November 14, 2023.

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 sign up to
automatically receive email alerts and other information about the Company by visiting the “Email Alerts” option under the News/Events section of the Investors & Media website section and submitting your email address.

About IGALMI™ (dexmedetomidine) sublingual film

INDICATION

IGALMI™ (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children.

IMPORTANT SAFETY INFORMATION

IGALMI can cause serious side effects, including:

  • Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint.
  • Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations.
  • Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI.
  • Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours.

The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing.

These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects.

Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids.

Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201- 1088 or [email protected].

Please see full Prescribing Information at igalmi.com.

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 indications. The Company’s commercial product, IGALMI™ (developed as BXCL501), is a proprietary, sublingual film formulation of dexmedetomidine approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The safety and effectiveness of IGALMI have not been established beyond 24 hours from the first dose. For more information, please visit igalmi.com and also see the IGALMI full Prescribing Information. BXCL501 is under evaluation for at-home use for the acute treatment of agitation in bipolar and schizophrenia patients, for acute treatment of agitation associated with Alzheimer’s disease, and as an adjunctive treatment for major depressive disorder. The safety and efficacy of BXCL501 for these uses have not been established. The Company is also developing BXCL502 as a potential therapy for chronic agitation in dementia. Under its subsidiary, OnkosXcel Therapeutics, the Company is developing BXCL701, an investigational, oral systemic innate immune activator for the treatment of aggressive forms of prostate cancer and other solid and liquid tumors. The safety and efficacy of BXCL502 and BXCL701 have not been established. For more information, please visit bioxceltherapeutics.com.

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the Company’s expected timing of, and data results from, trials and clinical studies involving its product candidates; the potential for the results from the Company’s completed, ongoing and proposed clinical trials to support regulatory approvals for its product candidates, including the results from the TRANQUILITY II and SERENITY III clinical trials; its ongoing marketing, commercialization and expansion efforts, plan and strategy for IGALMI; statements regarding the Company’s strategic reprioritization; anticipated cost savings; expected cash runway and cash burn rates; planned discussions with the FDA and paths to potential FDA approval of BXCL501; strategic options for OnkosXcel; the Company’s participation in upcoming events and presentations; potential modifications to the terms of the Company’s financing arrangements with Oaktree/QIA; future access to capital; and the Company’s future financial and operational results, including future revenue growth. The words “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. 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 ability to successfully negotiate amended terms under the financing agreements to be able to access funding and to obtain relief under financial covenants; its significant indebtedness and potential payment obligations related to such indebtedness and other contractual obligations; risks associated with the strategic reprioritization; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY II Phase 3 trial and related audit; its dependence on the success and commercialization of IGALMI™, BXCL501, BXCL502 BXCL701 and BXCL702 and other product candidates; its lack of experience in marketing and selling drug products; the risk that 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; the significant influence of and dependence on BioXcel LLC; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; impacts from the COVID-19 pandemic; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; its ability to commercialize its product candidates; and the other important factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as such factors may be updated from time to time in its other filings with the SEC, including without limitation, its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023, 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
BioXcel Therapeutics
Brennan Doyle
1.475.355.8462
[email protected]

Media
Russo Partners
David Schull or Scott Stachowiak
1.858.717.2310
[email protected]
[email protected]

Source: BioXcel Therapeutics, Inc.

IGALMI is a trademark of BioXcel Therapeutics, Inc. All other trademarks are the properties of their respective owners. Copyright © 2023, BioXcel Therapeutics, Inc. All rights reserved.

BioXcel Therapeutics, Inc.                              
Statements of operations                              
(in thousands, except per share amounts)                              
  Three months ended June 30,     Six months ended June 30,  
    2023       2022       2023       2022  
                               
Revenues $ 457     $     $ 663     $  
                               
Operating expenses                              
Cost of goods sold $ 26     $     $ 34     $  
Research and development $ 26,973     $ 17,906     $ 54,773     $ 36,593  
Selling, general and administrative $ 25,872     $ 18,382     $ 49,467     $ 31,175  
                               
Loss from operations $ (52,414 )   $ (36,288 )   $ (103,611 )   $ (67,768 )
Other expense (income)                              
Interest expense $ 3,259     $ 1,586     $ 6,627     $ 1,593  
Interest income $ (1,621 )   $ (204 )   $ (3,636 )   $ (219 )
Other income, net $ (537 )   $     $ (291 )   $  
                               
Net loss $ (53,515 )   $ (37,670 )   $ (106,311 )   $ (69,142 )
Net loss per share – basic and diluted $ (1.83 )   $ (1.35 )   $ (3.68 )   $ (2.47 )
Weighted average shares outstanding – basic and diluted   29,187       27,989       28,903       27,985  
                               
                               
Condensed Balance Sheets                              
(in thousands)                              
                               
   June 30, 2023      December 31, 2022                  
                               
Cash and cash equivalents $ 127,545     $ 193,725                  
Working capital $ 103,491     $ 169,970                  
Total assets $ 140,097     $ 205,853                  
Long-term liabilities $ 99,489     $ 96,180                  
Total liabilities $ 134,233     $ 129,078                  
Total stockholders’ equity $ 5,864     $ 76,775                  

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Artificial Intelligence

More than $9 Million Awarded to High School Scientists and Engineers at the Regeneron International Science and Engineering Fair 2024

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Grace Sun, 16, receives $75,000 Top Award for a new kind of organic electrochemical transistor at the world’s largest pre-college science, technology, engineering and math (STEM) competition.
TARRYTOWN, N.Y. and WASHINGTON, May 17, 2024 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Society for Science (the Society) announced that Grace Sun, 16, of Lexington, Kentucky, won the $75,000 top award, the George D. Yancopoulos Innovator Award, named in honor of the pioneering drug researcher and Regeneron co-Founder, Board co-Chair, President and Chief Scientific Officer, in the 2024 Regeneron International Science and Engineering Fair (Regeneron ISEF), the world’s largest pre-college science and engineering competition. Other top prizes went to projects in second-order cone programming, microplastics filtration and multi-sensory therapy for dementia.

The top winners were honored during two award ceremonies: the Special Awards on May 16 and the Grand Awards Ceremony on the morning of May 17. In total, over $9 million USD was awarded to the finalists based on their projects’ creativity, innovation and depth of scientific inquiry. The competition featured nearly 2,000 young scientists representing 49 U.S. states and nearly 70 countries, regions and territories across the world.
Grace Sun, 16, of Lexington, Kentucky, won first place and received the $75,000 George D. Yancopoulos Innovator Award for her research on building a better organic electrochemical transistor that she hopes will be used to develop new electronic devices that could help detect and treat serious illnesses like diabetes, epilepsy and organ failure. To overcome the problems that have previously prevented such devices from working effectively inside the body, Grace developed a new way of chemically treating their organic components, which greatly improved their laboratory performance.
Michelle Wei, 17, of San Jose, California, received one of two Regeneron Young Scientist Awards of $50,000 for her research to improve the speed and efficiency of a type of software that is useful in many fields such as machine learning, transportation and financial systems. Michelle’s new approach involved determining a quick approximate solution to the second-order cone programming problem, then splitting the initial cone into smaller cones, which enabled her new algorithm to greatly outperform previous approaches.
Krish Pai, 17, of Del Mar, California, received the second Regeneron Young Scientist Award of $50,000 for his machine-learning research to identify microbial genetic sequences that can be modified to biodegrade plastic. His new software, called Microby, scans databases of microorganisms and determines which ones can be changed genetically to biodegrade plastics. In tests, he identified two microorganisms that can be genetically modified to degrade plastic at a cost he believes would be ten times less than traditional recycling.
 “Congratulations to the Regeneron International Science and Engineering Fair 2024 winners,” said Maya Ajmera, President and CEO, Society for Science and Executive Publisher, Science News. “I’m truly inspired by the ingenuity and determination shown by these remarkable students. Coming from around the world with diverse backgrounds and academic disciplines, these students have shown that it is possible to come together in unity to tackle some of the toughest challenges facing our world today, and I could not be prouder.”
Regeneron ISEF provides a global stage for the world’s best and brightest young scientists and engineers. Through this competition, Regeneron and the Society are fostering the next generation of STEM leaders who are pioneering solutions to improve our world. Since 2020, Regeneron has provided STEM experiences to approximately 2.4 million students, on track to meet its goal of 2.5 million by 2025.
“The talent, intelligence and potential of this year’s Regeneron ISEF finalists is truly inspiring, and I congratulate each on their remarkable achievements,” said George D. Yancopoulos, M.D., Ph.D., co-Founder, Board co-Chair, President and Chief Scientific Officer of Regeneron. “Science competitions like ISEF were pivotal in shaping my own career and fueling my passion to fight back against disease. I look forward to seeing these students continue to push the boundaries of science and technology to create positive and sustainable change for all humanity.”
Other top honors from the competition include:
Justin Huang and Victoria Ou, both 17, of Woodlands, Texas, received the Gordon E. Moore Award for Positive Outcomes for Future Generations of $50,000 for their new prototype filtration system that uses ultrasonic waves to remove microscopic plastic particles from water. In lab tests, the acoustic force from the high-frequency sound waves removed between 84% and 94% of the suspended microplastic particles in a single pass. The students are now working to scale up and fine-tune their experimental system.
Ingrid Wai Hin Chan, 17, of Hong Kong, China received the Craig R. Barrett Award for Innovation of $10,000 for her research on using a multi-sensory therapy for dementia patients. Her mixed therapy app would allow patients to practice physical and cognitive skills through a personalized, immersive environment using virtual reality headsets. Ingrid conducted an eight-week study with six people living with dementia and found that the cognitive function of patients who used her prototype improved in several areas. She believes her app could serve as a viable option for dementia patients with limited access to in-person professional therapy.
Tanishka Balaji Aglave, 15, of Valrico, Florida, received the H. Robert Horvitz Prize for Fundamental Research of $10,000 for her investigation into a natural alternative treatment against citrus greening, a disease that threatens citrus farming in many parts of the world and is currently only treated with antibiotics. Tanishka injected the trunks of infected trees with an extract from the curry leaf tree, and found through tests that this potential method could effectively and sustainably manage citrus greening disease.
Maddux Alexander Springer, 18, of Honolulu, Hawaii, received the Peggy Scripps Award for Science Communication of $10,000 for his research into fibropapillomatosis (FP), a disease that is the primary cause of death in green sea turtles. Some turtles he studied in Kaneohe Bay, Hawaii, were stricken with a disease that causes internal and external tumors that inhibit their everyday lives. After analyzing the turtles’ diet of green algae, Maddux concluded that this disease, wastewater, invasive algae and the amino acid arginine all pose a grave risk to these endangered sea creatures.
Ria Kamat, 17, of Hackensack, New Jersey; Anna Oliva, 17, of Houston, TX; and Shuhan Luo, 18, of Worcester, MA, received the Dudley R. Herschbach SIYSS Award, which provides finalists an all-expense paid trip to attend the Stockholm International Youth Science Seminar during Nobel Week in Stockholm, Sweden.
Jack Shannon, 18, of Clane, Kildare, Ireland, and Nikhil Vemuri, 17, of Cary, North Carolina, received the EU Contest for Young Scientists Award. Their projects will represent Regeneron ISEF at the EU Contest for Young Scientists to be held this September in Katowice, Poland.
For more information about the top winners and access to visual assets visit:  https://www.societyforscience.org/isef-2024-media-kit.
The full list of Special Award ISEF 2024 Finalists can be found at https://www.societyforscience.org/press-release/regeneron-isef-2024-special-awards-winners.
In addition to the Top Award winners, more than 450 finalists received awards and prizes for their innovative research, including “First Award” winners, who each received a $5,000 prize.
The following lists the First Award winners for each of the 22 categories, from which the Top Awards were chosen:
Animal Sciences, sponsored by Society for ScienceMaddux Alexander Springer, Honolulu, Hawaii
Behavioral and Social Sciences, sponsored by Society for ScienceAndrew Y. Liang, San Jose, California
Biochemistry, sponsored by RegeneronAmy Hong Xiao, Garden City, New York
Biomedical and Health Sciences, sponsored by RegeneronRia Kamat, Hackensack, New Jersey; Kevin Xuan Lei, Shanghai, China
Biomedical Engineering, sponsored by Alfred E. Mann CharitiesAyush Garg, Dublin, California; Divij Motwani, Palo Alto, California; Akash Ashish Pai, Portland, Oregon
Cellular and Molecular Biology, sponsored by RegeneronLara and Maya Sarah Hammoud, Beverly Hills, Michigan
Chemistry, sponsored by Society for ScienceAkilan Sankaran, Albuquerque, New Mexico; Arjun Suresh Malpani and Siddharth Daniel D’costa, Portland, Oregon
Computational Biology and Bioinformatics, sponsored by RegeneronKun-Hyung Roh, Bronx, New York
Earth and Environmental Sciences, sponsored by Google.orgNikhil Vemuri, Durham, North Carolina; Justin Yizhou Huang and Victoria Ou, The Woodlands, Texas
Embedded Systems, sponsored by HPChloe Rae and Sophie Rose Filion, Welland, Ontario, Canada
Energy: Sustainable Materials and Design, sponsored by Siemens EnergyAlia Wahban, Hamilton, Ontario, Canada
Engineering Technology: Statics and Dynamics, sponsored by Howmet Aerospace FoundationChiyo Nakatsuji, Bunkyoku, Tokyo, Japan; Kevin Shen, Olympia, Washington
Environmental Engineering, sponsored by JacobsKrish Pai, San Diego, California; Jack Shannon, Clane, Kildare, Ireland
Materials Science, sponsored by Howmet Aerospace FoundationGrace Sun, Lexington, Kentucky
Mathematics, sponsored by Akamai FoundationAnna Oliva, Houston, Texas
Microbiology, sponsored by Schattner FoundationMatthew Chang, Irvine, California
Physics and Astronomy, sponsored by Richard F. Caris Charitable Trust IIHarini Thiagarajan and Vishal Ranganath Yalla, Bothell, Washington; Shuhan Luo, Worcester, Massachusetts
Plant Sciences, sponsored by Society for SciencePauline Estrada, Fresno, California; Tanishka Balaji Aglave, Dover, Florida
Robotics and Intelligent Machines, sponsored by RegeneronMichal Lajciak, Dubnica nad Vahom, Trenciansky kraj, Slovakia; Anthony Efthimiadis, Oakville, Ontario, Canada
Systems Software, sponsored by MicrosoftMichelle Wei, San Jose, California
Technology Enhances the Arts, sponsored by Society for ScienceAnant Khandelwal, Sritan Motati and Siddhant Sood, Alexandria, Virginia
Translational Medical Science, sponsored by RegeneronZheng-Chi Lee, West Lafayette, Indiana; Ingrid Wai Hin Chan, Hong Kong, China
The full list of all award-winning ISEF 2024 finalists is available here: https://www.societyforscience.org/press-release/regeneron-isef-2024-full-awards.
View all the finalists’ research here: https://projectboard.world/isef.
About the Regeneron International Science and Engineering FairThe Regeneron International Science and Engineering Fair (Regeneron ISEF), a program of Society for Science for over 70 years, is the world’s largest global science competition for high school students. Through a global network of local, regional and national science fairs, millions of students are encouraged to explore their passion for scientific inquiry. Each spring, a group of these students is selected as finalists and offered the opportunity to compete for approximately U.S. $9 million in awards and scholarships.
In 2019, Regeneron became the title sponsor of ISEF to help reward and celebrate the best and brightest young minds globally and encourage them to pursue careers in STEM to positively impact the world. Regeneron ISEF is supported by a community of additional sponsors, including Akamai Foundation, Alfred E. Mann Charities, Aramco, Caltech, Google.org, Gordon and Betty Moore Foundation, Howmet Aerospace Foundation, HP, , Jacobs, King Abdulaziz & his Companions Foundation for Giftedness and Creativity, Microsoft, National Geographic Society, Richard F. Caris Charitable Trust II, Rise, an initiative of Schmidt Futures and the Rhodes Trust, Schattner Foundation, Siemens Energy, Annenburg Foundation, Ballmer Group, Broadcom Foundation, Cesco Linguistic Services, Conrad N. Hilton Foundation, Edison International, Insaco, Oracle Academy, The Eli and Edythe Broad Foundation, The Ralph M. Parsons Foundation and US Army ROTC. Many are entrepreneurs across a wide range of industries. Learn more at https://www.societyforscience.org/isef/.
About Society for ScienceSociety for Science is a champion for science, dedicated to promoting the understanding and appreciation of science and the vital role it plays in human advancement. Established in 1921, Society for Science is best known for its award-winning journalism through Science News and Science News Explores, its world-class science research competitions for students, including the Regeneron Science Talent Search, the Regeneron International Science and Engineering Fair and the Thermo Fisher Scientific Junior Innovators Challenge, and its outreach and equity programming that seeks to ensure that all students have an opportunity to pursue a career in STEM. A 501(c)(3) membership organization, Society for Science is committed to inform, educate and inspire. Learn more at www.societyforscience.org and follow us on Facebook, Twitter, Instagram and Snapchat (Society4Science).
About RegeneronRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases and rare diseases. 
Regeneron believes that operating as a good corporate citizen is crucial to delivering on our mission. We approach corporate responsibility with three goals in mind: to improve the lives of people with serious diseases, to foster a culture of integrity and excellence and to build sustainable communities. Regeneron is proud to be included on the Dow Jones Sustainability World Index and the Civic 50 list of the most “community-minded” companies in the U.S. Throughout the year, Regeneron empowers and supports employees to give back through our volunteering, pro bono and matching gift programs. Our most significant philanthropic commitments are in the area of early science education, including the Regeneron Science Talent Search and the Regeneron International Science and Engineering Fair (ISEF).
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.
More information about the top winners and access to visual assets visit:  https://www.societyforscience.org/isef-2024-media-kit.
Media ContactsJoseph Brown, [email protected]
Gayle Kansagor, Society for [email protected]
Photo – https://mma.prnewswire.com/media/2416174/Regeneron_ISEF_2024_Winners_Photo.jpg 
Logo – https://mma.prnewswire.com/media/2416197/Society_for_Science_Logo.jpg 

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J.P. Morgan Life Sciences Private Capital, Blue Horizon Advisors and United Al Saqer Announce Winner of Inaugural 2024 Life Sciences Innovation Summit

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In conjunction with Abu Dhabi Global Healthcare Week 2024
ABU DHABI, UAE, May 17, 2024 /PRNewswire/ — J.P. Morgan Life Sciences Private Capital, Blue Horizon Advisors and United Al Saqer Group announced today Rayees Rahman of Harmonic Discovery as the winner of the inaugural J.P. Morgan Asset Management: Life Sciences Innovation Summit. Harmonic Discovery is a precision pharmacology company applying its generative chemistry platform to advance next-generation kinase inhibitors.

In partnership with the Department of Health – Abu Dhabi (DoH), the Summit took place on May 14-15, 2024 at Cleveland Clinic Abu Dhabi and showcased the 11 innovative finalists, as well as highlighted existing innovators and opportunities in the Emirate of Abu Dhabi. The event also featured keynote speeches from Dr. Laurie Glimcher of Dana-Farber Cancer Institute, Dr. Shahrukh Hashmi of the Department of Health – Abu Dhabi, and Dr. David Ho of Columbia University Medical Center and provided attendees networking opportunities to gain valuable insights into the future of life sciences innovation. 
In addition, the jury designated Chun-Hao Huang of Algen Biotechnologies as honourable mention. Algen Biotechnologies is a platform therapeutics and drug discovery company using world-leading CRISPR and AI to find treatments for cancer, inflammation and metabolic diseases.
The winners were selected by an esteemed, international panel of judges, which included:Laurie Glimcher, MD, President and CEO at Dana-Farber Cancer InstituteJorge Guzman, MD, CEO at Cleveland Clinic Abu DhabiProf. Shahrukh Khurshid Hashmi, MD, Director of Research, Department of Health, Abu DhabiYasmine Hayek Kobeissi, PhD, CQF, BSc., Executive Director at Blue Horizon AdvisorsAnya Schiess, Managing Partner at J.P. Morgan Life Sciences Private CapitalWalid Zaher, PhD, Co-Founder and CEO, Carexso
Dr. Asma Al Mannaei, Executive Director of the Research and Innovation Centre at the Department of Health – Abu Dhabi said: “Under the directives of the UAE’s wise leadership, and renowned for its world-leading medical infrastructure, Abu Dhabi stands at the forefront of healthcare excellence, offering an unparalleled opportunity for advancement in healthcare for global partners. It was our utmost pleasure hosting the J.P. Morgan Asset Management Life Sciences Innovation Summit 2024 on the sidelines of Abu Dhabi Global Healthcare Week and we commend the winners for their pioneering efforts in driving impactful advancements in healthcare; their dedication to innovation not only transforms the landscape of medicine, but also holds the promise of improving lives worldwide.” 
Stephen Squinto, PhD, Chief Investment Officer, J.P. Morgan Life Sciences Private Capital said: “We are thrilled with the level of biotech passion and innovation that we observed at this year’s Summit in Abu Dhabi. The energy was truly palpable we are thrilled to announce Rayees Rahman as the winner of our first Life Sciences Innovation Summit. Harmonic Discovery’s approach embodies the next generation of drug discovery and development. We appreciate the time and effort of all participants and cannot wait for our next event in the region.”
Nabil Kobeissi, Chief Executive Officer of Blue Horizon Advisors, said: “As the main sponsor, we are committed to nurturing and fostering the growth of all 11 finalists in this vibrant biotech ecosystem. This Summit marks the beginning of a transformative journey, and we are confident that it will pave the way for a flourishing hub in the region. We are also pleased to announce that we will commit to invest in and partner with the winner, Harmonic Discovery, to support its future growth in the region.”
Sponsors for the event included J.P. Morgan Life Sciences Private Capital, J.P. Morgan Commercial Bank, Blue Horizon Advisors, United Al Saqer Group, Thermo Fisher Scientific, and Salam Capital. The Summit organisation, logistics and finalist recruitment were facilitated by Lyfebulb.
Of importance, at the Summit, Mr. Mohamed Al Breiki, Executive Director of Sustainable Development at Masdar City, announced that Masdar City Free Zone would award all 11 Finalists complimentary business licenses to further support their establishment in the region. Masdar City is one of the world’s most sustainable urban developments and innovation hubs with a growing focus on life science entrepreneurship in Abu Dhabi.

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Congregating in the Lion City for a Win-Win Future of Intelligent Computing at the Global Data Center Facility Summit 2024

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SINGAPORE, May 17, 2024 /PRNewswire/ — On May 17, 2024, the Global Data Center Facility Summit 2024 was held in Singapore with the theme of “Power the Digital Era Forward.” At the summit, over 600 data center industry leaders, technical experts, and ecosystem partners gathered to discuss new trends and opportunities of the global data center industry in the intelligent computing era. The attendees also got to experience all-scenario, all-ecosystem, and all-service end-to-end (E2E) solutions, share innovative practices of green data centers in the Asia Pacific and Europe, and experience the exhibition vehicle to unveil the mystery of Outdoor PowerPOD that features one power system per container. By fully embracing the intelligent computing era, Huawei strives to power the digital era forward.

Seizing Opportunities Brought by AI and Jointly Building Green & Reliable Computing Infrastructure
At the opening speech, Charles Yang, Senior Vice President of Huawei and President of Marketing, Sales and Services, Huawei Digital Power, noted that since ChatGPT ushered in the AI era, large models keep pushing the limits of computing power and the intelligent computing industry is witnessing an unprecedented construction boom. As predicted, 100 GW will be added to the global data center installed capacity and the market value will exceed US$600 billion in the next five years.
According to Charles, with opportunities come challenges. The primary challenge concerning the data center industry is reliability and electricity. Data centers are scaling up from the MW-level to the GW-level. E2E reliability of data centers is becoming even more important than ever. In response to the opportunities, Huawei will work with customers and partners to expand the industry space.
Steering Data Centers to the AI Era with Product + Service + Ecosystem
During the summit, Sun Xiaofeng, President of Huawei Data Center Facility & Critical Power Business, delivered a speech titled “Power the Digital Era Forward. ” He stated that as AI large models are penetrating, the surging compute demands drive the expansive growth in data center.
To address the challenges, Huawei strives to build product + service + ecosystem E2E data center solutions that feature fast deployment, flexible cooling, green energy, and ultimate reliability.
Fast deployment: Data centers are fully modularized and prefabricated to ensure high quality and efficient construction.Flexible cooling: Air-liquid fusion and integrated cooling source emerges as the optimal cooling architecture for intelligent computing.Green energy: New generation-grid-load-storage integrated solution is built to ensure the sound operations of intelligent computing centers.Ultimate reliability: Data centers are safeguarded through reliable products and preventive protection.Currently, Huawei’s global service network covers more than 170 countries with over 1800 professional engineers, providing 24/7 technical support. With N+ flagship service centers, Huawei has built a one-hour service radius for its customers.
The ecosystem is a key part for a win-win future of intelligent computing. Huawei works with partners to develop comprehensive E2E solutions and provide customers with one-stop data center services.
During the summit, Huawei and the ASEAN Centre for Energy released a white paper on “Building Next Generation Data Center Facility in ASEAN.” The document provides insights into the status quo, challenges, and trends of data centers in the ASEAN region, and emphasizes that efficient and energy-saving products and solutions should be applied. It also proposes future-oriented policy recommendations for data center markets.
In the ecosystem exhibition area, Huawei showcased scenario-based solutions for large-, medium-, and small-sized data centers, and demonstrated data center consulting, design, integrated development, and delivery capabilities with dozens of ecosystem partners including CIMC, Weichai, CSCEC, and Huashi.
On a special note, the Huawei Outdoor PowerPOD exhibition vehicle made its global debut. The Huawei Outdoor PowerPOD features one power system per container, outdoor deployment, plug-and-play, and high protection rating and reliability. It has become the preferred choice for decoupling the power supply architecture.
A single tree cannot make a forest.
AI is presenting great opportunities. By delving into the industry, aggregating partner ecosystems, and making innovations applicable to transformations, Huawei will continue to help customers build reliable computing infrastructure, accelerating the industry to embrace AI and powering the digital era forward.
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