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Cingulate and Indegene Announce Joint Commercialization Agreement for Lead ADHD Candidate CTx-1301

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Go-to-Market Solution Provides Full Commercial Support for the First, True Entire Active-Day Medication Designed to treat ADHD

Indegene Model Geared for Efficient National Commercial Launch in Multibillion-Dollar ADHD Market

KANSAS CITY, Kan. and PRINCETON, N.J., March 13, 2023 (GLOBE NEWSWIRE) — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, and Indegene, a digital-first, life sciences commercialization company, today announced a joint commercialization agreement to provide commercial support for Cingulate’s lead candidate CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for attention deficit/hyperactivity disorder (ADHD), upon approval from the U.S. Food and Drug Administration (FDA).

The agreement spans cross-functional services through an omnichannel marketing approach uniquely designed to successfully manage pre-commercial support during Cingulate’s Phase 3 clinical trials and to effectively commercialize CTx-1301 nationwide following potential FDA approval. Cingulate recently announced the initiation of its first Phase 3 trial for CTx-1301, an adult dose-optimization efficacy and safety study to assess onset and duration, with results expected in the third quarter of 2023. In addition, the Company plans to initiate its pivotal Phase 3 trial, a fixed-dose, placebo-controlled study in pediatric and adolescent patients with ADHD, in mid-2023.

“This agreement provides a clear path to commercialize CTx-1301, upon FDA approval, designed specifically to tackle the unmet needs of this $20 billion market by providing the first true, entire-active-day treatment for ADHD. But the clinical success of a potential treatment can only be realized with commercial excellence, making this partnership between Cingulate and Indegene a critical step for our Company,” said Shane J Schaffer, Chairman and CEO, Cingulate. “We believe Indegene provides a comprehensive solution combining sales professionals and field medical personnel, and its AI-driven omnichannel marketing suite is unparrellled in the industry, making them the right partner at the right time to help Cingulate redefine the ADHD treatment paradigm. Additionally, this allows Cingulate to focus on clinical development by reducing the internal resources and risks associated with building out these functional areas.”

Cingulate’s comprehensive agreement with Indegene covers most facets of the commercialization process, including sales, PRMA (pricing, reimbursement and market access), medical affairs, medical communications, pharmacovigilance, regulatory, marketing and commercial operations support. The partnership is focused on driving revenue and is designed to ensure predictable cash outflow and continues through three years post-launch of CTx-1301.

“We believe the unique attributes of CTx-1301 differentiate Cingulate’s product from other available products in the market, which aligns well to Indegene’s omnichannel approach to raising awareness among physicians and patients,” said Timothy Moore, Senior Vice President of Emerging Biotech at Indegene.

Data show that Indegene’s omnichannel marketing solution has a greater impact than field sales representatives alone, with better customer experiences at a fraction of the cost of the more traditional model. Utilizing proprietary artificial intelligence (AI) and data to reach health care professional (HCP) targets in the most effective and efficient manner, Indegene leverages a large database of HCPs and HCP interactions to develop a curated sales and marketing strategy. An algorithm then learns and adapts in real-time to deliver content that ultimately changes prescribing behaviors.

“We believe the ability to deploy Indegene’s range of digital best practices and new communications channels will play a large role in the pre-launch preparation, and enable Cingulate to immediately tap into the proven market access, sales force effectiveness and medical commercialization operations critical to a successful launch,” Moore added. “We have worked with 19 of the top 20 global pharmaceutical companies, and this joint commercialization agreement expands Indegene’s services to an emerging growth company, positioning Cingulate for success in the event CTx-1301 is approved by the FDA.”

Of the multitude of medications available for the more than 17 million child, adolescent, and adult patients in the U.S. living with ADHD, there is currently no available medication offering a single oral dose that provides patients entire active-day efficacy. CTx-1301 aims to be the first medication to achieve fast onset of action (in 30 minutes or less) and efficacy that lasts up to 16 hours while improving patient tolerability.

About CTx-1301
Cingulate’s lead candidate, CTx-1301, utilizes the Company’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior.

While stimulants are the gold-standard of ADHD treatment due to their efficacy and safety, the long-standing challenge remains, providing patients entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off.

The company has initiated the first of two Phase 3 clinical studies of CTx-1301 to support its NDA submission. The pivotal, Phase 3 fixed-dose trial in children and adolescents is scheduled to begin in mid-2023.

About Precision Timed Release™ (PTR™) Platform Technology
Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using the Company’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma.

Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies.

For more information visit Cingulate.com/technology.

About Cingulate Inc.
Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR™ drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information visit Cingulate.com.

About Indegene
We are a digital-first, life sciences commercialization company. We help biopharmaceutical, emerging biotech and medical device companies develop products, get them to the market, and grow their impact through the life cycle in a more effective, efficient, and modern way. We bring together healthcare domain expertise, fit-for-purpose technology, and an agile operating model to provide a diverse range of solutions. These aim to deliver, amongst other outcomes, a personalized, scalable and omnichannel experience for patients and physicians. It’s what drives our team and our purpose to enable healthcare organizations to be future ready. To learn more, please visit www.indegene.com

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature.

These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 28, 2022. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Investor Relations:

Thomas Dalton
Vice President, Investor & Public Relations, Cingulate
[email protected]
(913) 942-2301

Matt Kreps
Darrow Associates
[email protected]
214-597-8200

Media Relations:

Melysa Weible
Elixir Health Public Relations
[email protected]
201-723-5805

Yadunandan K V
Director – Corporate Communications, Indegene
[email protected]

CING-US-120-0324

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US Air Force Awards ThroughPut.ai Direct-to-Phase-II Contract for Boeing, Lockheed Martin, and Sikorsky Mission Design Series to Accelerate Aircraft Readiness

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Leveraging Data to Drive Maintenance-first actions that improve overall supply chain throughput across the DAF.
NEW YORK, May 28, 2024 /PRNewswire/ — ThroughPut.ai, the Supply Chain Decision Intelligence Pioneer, announces it has been selected by AFWERX for a (SBIR Direct-to-Phase II contract) in the amount of $1,248,627.00 focused on “AI-Powered Proactive Supply Chain Capabilities” to address the most pressing challenges in the Department of the Air Force (DAF). The Air Force Research Laboratory and AFWERX have partnered to streamline the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) process by accelerating the small business experience through faster proposal to award timelines, changing the pool of potential applicants by expanding opportunities to small business and eliminating bureaucratic overhead by continually implementing process improvement changes in contract execution. The DAF began offering the Open Topic SBIR/STTR program in 2018 which expanded the range of innovations the DAF funded and now on April 17th, 2024, ThroughPut.ai will start its journey to create and provide innovative capabilities that will strengthen the national defense of the United States of America.

“ThroughPut.ai looks forward to supporting efforts to accelerate inventory flow across the United States Air Force,” said Ali Raza, CEO & Founder of ThroughPut.ai. “By driving inventory/materiel management changes at the maintenance endpoint first, supply chain improvements can then be amplified across the greater industrial base to create aircraft capacity.”
“The views expressed are those of the author and do not necessarily reflect the official policy or position of the Department of the Air Force, the Department of Defense, or the U.S. government.”
About (ThroughPut.ai)
ThroughPut.ai is a Silicon Valley-based supply chain optimization & predictive replenishment company. The company’s software AI platform has the ability to identify location-, product-, and customer-based demand changes sooner in order to adjust order frequencies, vendor sources, and parts buffer levels at a global and local scale. ThroughPut’s platform was designed by Fortune 500 & technology executives with real-world experience managing demand & supply chain disruptions and war-zone logistics across the Middle East.
About AFRLThe Air Force Research Laboratory is the primary scientific research and development center for the Department of the Air Force. AFRL plays an integral role in leading the discovery, development, and integration of affordable warfighting technologies for our air, space and cyberspace force. With a workforce of more than 12,500 across nine technology areas and 40 other operations across the globe, AFRL provides a diverse portfolio of science and technology ranging from fundamental to advanced research and technology development. For more information, visit afresearchlab.com.
About AFWERXAs the innovation arm of the DAF and a directorate within the Air Force Research Laboratory, AFWERX brings cutting-edge American ingenuity from small businesses and start-ups to address the most pressing challenges of the DAF. AFWERX employs approximately 370 military, civilian and contractor personnel at five hubs and sites executing an annual $1.4 billion budget. Since 2019, AFWERX has executed over 6,100 new contracts worth more than $4 billion to strengthen the U.S. defense industrial base and drive faster technology transition to operational capability. For more information, visit: www.afwerx.com. 
Company Press Contact:Ali RazaCEO/[email protected] 

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Data Center Investments Soar: 200% Rise Since 2016 and Projected 89% Increase by 2028

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USA News Group CommentaryIssued on behalf of Avant Technologies Inc.
VANCOUVER, BC, May 28, 2024 /PRNewswire/ — Since 2016, investment in data centre infrastructure has risen 200%, with a further 89% increase expected by 2028 as more opportunities emerge with the rise of artificial intelligence (AI). According to Jones Lang LaSalle Inc.’s CEO Christian Ulbrich, data centers are “the hottest asset class at the moment.” Analysts at Technavio are projecting the global data center market to record an additional US$329.82 billion in growth at a CAGR of 12.73% through 2027. Capitalizing on the opportunity are several players recently announcing developments regarding their involvement in the data centers sector, including

Avant Technologies Inc. (OTCQB: AVAI), Amazon.com, Inc. (NASDAQ: AMZN), Applied Digital Corporation (NASDAQ: APLD), Digital Realty Trust, Inc. (NYSE: DLR), and Equinix, Inc. (NASDAQ: EQIX).
As an early pioneer in generative AI, Avant Technologies Inc. (OTCQB: AVAI) continues to enhance its flagship asset, Avant AITM, a sophisticated machine and deep learning AI system designed for versatility and customization across various industries and applications. Recently, Avant announced plans to equip its AI-managed data center, currently in development, with High-Performance Computing (HPC) systems. According to IBM, HPC technology utilizes clusters of powerful processors working in parallel to process massive multi-dimensional data sets and solve complex problems at exceptionally high speeds.
“The rise of AI is revolutionizing industries, and Avant Technologies is committed to being at the forefront of this transformation,” said William Hisey, CEO of Avant. “By building an AI-managed data center with HPC systems, we will gain the computational power and infrastructure required to train and deploy sophisticated AI models, which will ultimately provide even greater value to our customers.”
The new data center will leverage AI-driven management technology to optimize resource allocation and enhance efficiency in all aspects of data center operations. Avant will meticulously design its HPC infrastructure to meet the demands of AI workloads, selecting high-performance CPUs and GPUs (or TPUs) specifically suited for deep learning tasks. This cutting-edge facility will enable Avant to accelerate AI advancements, delivering innovative solutions to clients by improving data center efficiency and empowering them with exceptional AI capabilities.
Additionally, Avant will implement a high-speed network to ensure efficient data transfer and select a scalable storage solution to manage the large datasets necessary for training and utilizing AI models. The HPC systems will prioritize security, incorporating robust measures to protect sensitive data and create a secure environment for AI deployment. Furthermore, the data center will integrate energy-efficient technologies and sustainable design practices, reflecting Avant’s commitment to environmental responsibility.
Avant Technologies also recently announced plans to implement AI-empowered Zero Trust Architecture (ZTA) across its data center operations. Additionally, the company has expanded its AvantAI™ platform to include intelligent, proactive monitoring and management for data centers.
Over the past few weeks Amazon.com, Inc. (NASDAQ: AMZN) has collectively committed to investing $20 billion into new data centers for its subsidiary Amazon Web Services (AWS). The first to be announced was an $11-billion data center to be built in Indiana, with another $9 billion set to accelerate cloud-infrastructure in Singapore. The moves fall in line with Amazon CEO Andy Jassy’s projection that 85% of IT spending will remain on premises, in the race for Gen AI supremacy.
Amazon also recently announced an extension on its partnership between AWS and CrowdStrike to unify cybersecurity protection on its CrowdStrike Falcon platform. As per the agreement, Amazon is replacing a variety of cloud point products with Falcon Cloud Security, is using Falcon Next-Gen SIEM to secure big data logging and is deploying Identity Threat Detection and Response to prevent identity-based attacks.
“CrowdStrike and AWS have a deep history of working together to secure the most innovative companies in the world,” said CJ Moses, Chief Information Security Officer and Vice President of Security Engineering at Amazon. “Amazon uses CrowdStrike to provide visibility, detection, and response across our businesses in order to protect the cloud, infrastructure, and services for our customers. This is part of our shared mission to help all organizations build, operate, and secure their business.”
In a move to shore-up its market position as a designer, builder, and operator of next-generation digital infrastructure designed for High-Performance Computing (“HPC”) applications, Applied Digital Corporation (NASDAQ: APLD) recently announced the appointment of industry veteran Todd Gale as its new Chief Development Officer. The announcement came just one month after the company announced it had issued a $50 million unsecured convertible debenture to advance its HPC Data Center Project in Ellendale, North Dakota.
“We intend to use the net proceeds from the private financing, supplemented by the proceeds from our announced sale of the Garden City facility, to finance substantial advancements in our construction phase of the HPC data center in Ellendale, North Dakota,” said David Rench, CFO of Applied Digital. “Concurrently, we continue negotiating our project-level financing to ensure timely project completion and fulfillment of our contractual obligations.”
Applied Digital intends to utilize chipmaking giant NVIDIA’s new Blackwell platform into its cloud offerings. The company’s next-generation data center campuses are specifically designed to host HPC/AI applications, offering more cost-effective and efficient alternatives to traditional data centers.
In Japan, Digital Realty Trust, Inc. (NYSE: DLR) recently announced the expansion of its NRT Campus, by commencing construction of its third data center to support AI. Upon completion of the site in late 2025, the campus’s capacity will rise to 104MW, with the intention of meeting rising demand for next-generation infrastructure, and seamless access to Japan’s connected data communities.
“Japan’s rapidly increasing demand for AI deployments creates the need for scalable, flexible, and highly connected AI-ready data centers in the Tokyo metropolitan area,” said Serene Nah, Managing Director and Head of Asia Pacific, Digital Realty. “We believe NRT14’s next-generation data center infrastructure and Digital Realty’s connected global open data center platform provide the foundational pillars our customers need to drive innovation in the coming years.”
Equinix, Inc. (NASDAQ: EQIX), another digital infrastructure company, has recently launched a $600 million joint venture with PGIM Real Estate to develop and operate the first xScale data center in the US, situated in California’s Silicon Valley. This follows their successful collaboration on the first xScale data center in Australia in 2022, which was part of a similar $575 million joint venture announced in 2021.
Under the terms of the new agreement, PGIM Real Estate will hold an 80% equity interest in the joint venture, while Equinix will retain a 20% equity stake. xScale data centers by Equinix enable hyperscale companies to expand their core deployments within Equinix’s IBX data centers, facilitating growth in over 70 global metros through a platform that supports direct interconnections with more than 10,000 customers.
This joint venture complements Equinix’s existing hyperscale collaborations in Europe, Asia-Pacific, and the Americas, significantly enhancing the global xScale data center portfolio. Once completed, this global expansion is set to exceed $8 billion, encompassing more than 35 facilities and providing over 725 megawatts of power capacity.
Source: https://usanewsgroup.com/2023/10/26/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/ 
CONTACT:USA NEWS [email protected](604) 265-2873
DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. (“MIQ”). MIQ has been paid a fee for Avant Technologies Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares Avant Technologies Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Avant Technologies Inc. which were purchased as a part of a private placement. MIQ reserves the right to buy and sell, and will buy and sell shares of Avant Technologies Inc. at any time thereafter without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been approved by the above mentioned company; this is a paid advertisement, and we own shares of the mentioned company that we will sell, and we also reserve the right to buy shares of the company in the open market, or through further private placements and/or investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.

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Lucinity Wins the Microsoft Partner Awards for 2024 for Partner of the Year – Iceland and Sustainability and Social Impact

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REYKJAVÍK, Iceland, May 28, 2024 /PRNewswire/ — Lucinity, a leading AI company for financial crime prevention, won two awards at the Microsoft Partner Awards for 2024, including Partner of the Year – Iceland and Sustainability and Social Impact, highlighting Lucinity’s innovations and contribution to positive societal change. 

“Congratulations to Lucinity for being recognized as the Partner of the Year – Iceland 2024! Lucinity is leading digital transformation and delivering innovative products in their domain,” says Microsoft’s leadership.
“For the past year, they have played a key role with their offerings, skilled resources, and their ability to drive change and innovative solutions both locally in Iceland and across the globe. Lucinity has had significant social impact and growth while supporting our joint customers in their AI-transformation journeys.”
In June 2023, Lucinity launched the world’s first copilot for FinCrime prevention powered by Microsoft Azure OpenAI called Luci. Luci stands out in the financial services industry with specialized skills for FinCrime prevention such as adverse media checks, case analysis, and SAR writing. 
Built on the robust and scalable Microsoft Azure platform, Lucinity offers customers a trusted SaaS product. Additionally, Lucinity’s presence on the Microsoft Azure Marketplace allows companies to leverage their Microsoft Azure credits to access the platform. 
The seamless integration with Microsoft’s Azure stack has enabled Lucinity to implement advanced AI capabilities, fostering rapid innovation and enabling banks and fintech companies to utilize AI securely and audibly. Furthermore, Luci significantly reduces investigation times from 2.5 hours to just 25 minutes, saving Tier 1 banks an estimated $25 million annually.
Guðmundur Kristjánsson (GK), Lucinity’s Founder and CEO comments, “These awards are a testament to the strength and reliability of our solutions, made possible by our strategic partnership with Microsoft. Utilizing Microsoft Azure, we have been able to drive rapid innovation and create a robust, scalable platform that meets the rigorous requirements of compliance teams.” 
On the Sustainability and Social Impact Partner Award, Microsoft says, “Lucinity, with their innovative AI solutions, has really tried to combat this huge global challenge. They use ‘Human AI’ to enhance financial crime prevention, combining AI with human expertise for efficient, user-friendly solutions. Additionally, Lucinity has developed a tool called Luci, an AI-powered copilot that helps transform financial crime prevention from a process that took hours to one that takes minutes.”
Logo: https://mma.prnewswire.com/media/2208676/4669079/Lucinity_Logo.jpg
 

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