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Release – Cadrenal Therapeutics Highlights Presentation Of New Trial Data At ISHLT Conference Demonstrating The Importance Of Anticoagulation Quality In LVAD Patients

Posted on June 3, 2024June 3, 2024 by aweinsoff@channelchek.com

Tecarfarin, which recently received Orphan Drug Designation from the FDA for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device, has the potential to improve the time in therapeutic range a factor correlated in the ARIES-HM3 trial with better patient outcomes

PONTE VEDRA, Fla., June 3, 2024 — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions, today highlighted a groundbreaking presentation at the International Society for Heart & Lung Transplantation (ISHLT) 44th Annual Meeting & Scientific Sessions.

These new findings from secondary analyses of the ARIES-HM3 trial were released in a presentation titled, “Impact of Vitamin K Antagonist (VKA) Therapy On Outcomes In a Randomized Controlled Trial of Aspirin Removal In Left Ventricular Assist Device (LVAD) Patients – A Pre-Specified Analysis From the Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure, or the ARIES-HM3, Randomized Clinical Trial.”

The ARIES-HM3 trial data demonstrated that lower time in therapeutic range, or TTR, translated directly to excessive bleeding events. The “average” patient in the ARIES-HM3 study had a 30% rate of serious bleeding events even after aspirin was eliminated as part of the antithrombotic regimen, and persistent bleeding was inversely correlated with TTR.

The ARIES-HM3 clinical study was sponsored by Abbott (NYSE: ABT), which evaluated a new clinical approach to patient management that included removal of aspirin as part of the antithrombotic regimen warfarin. The data is currently under review by the FDA. Labeling changes related to the antithrombotic regimen have not been approved by the FDA at this time.

Dr. Mandeep Mehra, who chaired the ARIES-HM3 study, holds the William Harvey Distinguished Chair in Advanced Cardiovascular Medicine and is Executive Director of the Center for Advanced Heart Disease at Brigham and Women’s Hospital, commented, “This comprehensive analysis identifies adequacy of VKA use (as measured by TTR) as a significant risk marker for bleeding events and provides new clinical direction for further mitigation of bleeding to enhance hemocompatibility with the HeartMate 3 LVAD.” Mehra continued, “Each incremental improvement of 10% above the median of 56% TTR trends in a significant further reduction in bleeding rate. Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic anti-coagulation since it does not get affected by drug-drug interactions or changes in kidney function like warfarin and deserves further study.”

“The ARIES-HM3 trial data underscores the deficiencies of warfarin and the need for a new VKA therapy for patients with LVADs. We believe our drug candidate, the next-generation VKA tecarfarin, with its unique retrometabolic design that provides for more stable anticoagulation than warfarin, is the much-needed replacement therapy. We intend to pursue a pivotal trial evaluating tecarfarin effectiveness for LVAD patients,” said Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “Cadrenal commends Abbott’s commitment to LVAD patients in sponsoring this important trial and analyses.”

On April 9, 2024, Cardenal Therapeutics announced that the United States Food and Drug Administration (FDA) had granted tecarfarin Orphan Drug Designation for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device, which includes the left ventricular assist device (LVAD).

The current market-leading direct oral anticoagulants (DOACs), such as Eliquis, are not indicated for patients with LVADs due to a lack of evidence of benefit, while the level of anticoagulation achieved with warfarin was achieved in the target range only 56% of the time in the ARIES-HM3 trial. Patients whose level of anticoagulation was in the therapeutic range > 56% had better outcomes than those with lower levels. This highlights the potential role for investigating new VKA agents in improving clinical outcomes in LVAD patients.

VKA anticoagulation is prescribed for the prevention of LVAD-related clotting. However, the only available VKA is warfarin, which was approved for human use in 1954. Tecarfarin has been shown to improve TTR, particularly in patients taking multiple medications, and be more stable in patients with renal dysfunction which is common in LVAD patients.

ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions. Tecarfarin has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib) and just received orphan drug designation for the prevention of thrombosis and thromboembolism in patients with ventricular assist devices (VADs). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with thrombotic antiphospholipid syndrome (APS). Tecarfarin is a next-generation Vitamin K Antagonist (VKA) specifically designed to use a different metabolism pathway than the oldest and most commonly prescribed VKA warfarin. Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.

Safe Harbor Statement
Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding tecarfarin having the potential to improve the time in therapeutic range which analysis of the ARIES-HM3 trial reveals is associated with better patient outcomes. TTRs as predicting increased risk for bleeding events, the VKA tecarfarin, filling the market void for a next-generation VKA, the Company pursuing a pivotal trial evaluating tecarfarin effectiveness for LVAD patients. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to improve the time in therapeutic range, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

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SOURCE Cadrenal Therapeutics, Inc.

Release – Tonix Pharmaceuticals Presented New Data on Tonmya™ Suggesting Activity for Improvement in Fibromyalgia-Associated Depression Severity in an Oral Presentation at ASCP Annual Meeting

Posted on June 3, 2024June 3, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 03, 2024 8:00am EDT

Tonmya treatment was associated with improvement in depressive symptoms as measured by the Beck Depression Inventory-II

In addition, post-hoc analyses showed improvement in depression, anxiety, memory and energy items on the Fibromyalgia Impact Questionnaire-Revised

New Drug Application (NDA) submission to the FDA on track for the second half of 2024

CHATHAM, N.J., June 03, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, presented new data from the Phase 3 RESILIENT trial of Tonmya (TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia in an oral presentation at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting on May 29, 2024 in Miami Beach, Fla. A copy of the presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

In the oral presentation titled, “Effects of Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl) on Mood and Anxiety Symptoms in Fibromyalgia: Results of the Phase 3 RESILIENT Trial,” Seth Lederman, MD, Chief Executive Officer, presented new data suggesting activity for improvement in depressive symptoms with Tonmya.

Depression was frequent among patients enrolled in the RESILIENT trial: ~47% reported experiencing depression within the past 6 months upon fibromyalgia diagnosis and ~25% of the intent-to-treat (ITT) population had experienced a lifetime major depressive episode (MDE). The effect of Tonmya on depressive symptoms was studied using the Beck Depression Inventory-II (BDI-II). Patients started with a baseline mean (standard deviation) for placebo of 10.0 (6.72) and Tonmya of 9.6 (6.32). The BDI-II score separated at Week 2 with a nominal p-value of <0.01. By Week 14, the total BDI-II score in the TNX-102 SL group improved over placebo with a nominal p-value of 0.005 and an effect size of 0.27.

Dr. Lederman said, “Although pain is the prototypic symptom in fibromyalgia and the validated FDA endpoint for the approval of a new drug, depression severity is also a prominent factor in the quality of life for fibromyalgia sufferers. In one study, depressive symptoms had a higher correlation with impaired quality of life than any other symptom, including pain frequency and intensity.² The improvement in depression observed in the Phase 3 RESILIENT was particularly striking since the mean entry score of 10 reflects mild depression. Others have struggled to show benefits of traditional antidepressants in mild depression and consequently many antidepressants have been studied in moderate or severely depressed patients and the benefits of such drugs for patients with mild depression have been inferred.”

Dr. Lederman continued, “In addition to the BDI-II score, in post hoc analyses several individual items on the Fibromyalgia Impact Questionnaire-Revised (FIQR) also improved in the Tonmya-treated group, including : depression (p < 0.001), anxiety (p = 0.001), sensitivity (p = 0.020), memory problems (p = 0.001) and energy (p < 0.001), for which these p-values were not corrected for multiplicity. Together these findings indicate that Tonmya has broad-spectrum activity against fibromyalgia symptoms and may improve fibromyalgia at the syndromal level.”

In the RESILIENT trial, as previously reported, Tonmya improved overall daily pain (p=0.00005), the pre-specified primary endpoint, making it the second Phase 3 study of Tonmya in the management of fibromyalgia to reach statistical significance on the pre-specified primary endpoint. Tonmya also demonstrated statistically significant and clinically meaningful results in all six pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function.”

In the RESILIENT trial, there were no new safety signals, low rates of systemic adverse events, and a favorable tolerability profile.

Tonix remains on track to submit an NDA to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia and has scheduled a Type B pre-NDA meeting with FDA for the second quarter of 2024.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya¹, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace^® SymTouch^® (sumatriptan injection) 3 mg and Tosymra^® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

¹Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

²Offenbaecher M, et al. Pain is not the major determinant of quality of life in fibromyalgia. Rheumatology International 2021; 41:1995–2006

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Source:

Released June 3, 2024

Haynes International (HAYN) – Acquisition Expected to Close in the Fourth Calendar Quarter of 2024

Posted on June 3, 2024June 3, 2024 by cpereira@noblefcm.com

Monday, June 03, 2024

Haynes International, Inc. is a leading developer, manufacturer and marketer of technologically advanced, nickel and cobalt-based high-performance alloys, primarily for use in the aerospace, industrial gas turbine and chemical processing industries.

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Merger receives regulatory scrutiny in the United Kingdom and in Austria. The Competition and Markets Authority in the United Kingdom (CMA) intends to conduct a formal investigation into Haynes’ proposed merger with North American Stainless, Inc., a wholly owned subsidiary of Acerinox S.A. This follows the Austrian Federal Competition Authority’s referral to the Austrian Cartel Court for a Phase II investigation of the transaction (See our research note dated May 3).

Closing expected in the fourth calendar quarter of 2024. Haynes’ management remains optimistic that the regulatory reviews will be positively resolved, and the required clearances will be obtained. Based on the expected timeline of the U.K. formal investigation and the Austrian Phase II investigation, Haynes now expects the merger will close in the fourth calendar quarter of 2024. While the timeline has been extended one calendar quarter, we remain confident that the new timeline will allow enough time for both examinations to run their course with outcomes that support a fourth calendar quarter closing.

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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.

Aurania Resources (AUIAF) – Private Placement Financing Successfully Closed

Posted on June 3, 2024June 3, 2024 by cpereira@noblefcm.com

Monday, June 03, 2024

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Third and final tranche closed. Aurania closed the third and final tranche of its non-brokered private placement financing. With the third tranche, the company raised gross proceeds of C$724,400.00 with the sale of 3,622,000 units at a price of C$0.20 per unit. In total, the private placement raised gross proceeds of C$3,743,222.40 with the sale of 18,716,112 at a price of C$0.20 per unit. The proceeds will fund exploration and target refinement at the Kuri-Yawi target area in Ecuador, along with general working capital needs.

Exploration plan. Aurania’s 2024 exploration program will focus on the Kuri-Yawi epithermal gold target. In 2020 and 2021, nine scout holes were drilled, totaling 4,957 meters, to test soil geochemistry anomalies and one of the geophysical anomalies detected during a MobileMT survey in 2021. The results revealed intense and pervasive hydrothermal clay mineral alteration and silica-carbonate veinlets exhibiting epithermal textures which are features consistent with proximity to an epithermal system. While Aurania’s property package offers an abundance of promising targets, Kuri-Yawi may offer the quickest path for a successful outcome based on work that has already been completed.

Get the Full Report

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

GameStop Stock Erupts Again as ‘Roaring Kitty’ Reveals $175 Million Position

Posted on June 3, 2024June 4, 2024 by slightbourne@noblecapitalmarkets.com

The original meme stock mania has been reawakened with a vengeance. GameStop (GME) shares skyrocketed over 70% amid frantic trading on Monday after retail trader Keith Gill, popularly known as “Roaring Kitty,” revealed a colossal new bullish position in the video game retailer.

In his first major post on Reddit in years, Gill shared a screenshot that appeared to show a staggering $175 million bet on GameStop. The purported stake consisted of 5 million shares valued at $116 million and $65.7 million worth of call options expiring in June.

The revelation instantly reignited the meme stock frenzy. Feverish trading volumes in GameStop stock spiked more than tenfold, briefly surpassing even the mighty Apple (AAPL) at one point. By mid-morning, GameStop’s heavily shorted shares had skyrocketed as high as 75% in an explosive upward move reminiscent of the legendary January 2021 short squeeze.

Fellow meme favorites like AMC Entertainment (AMC) caught a powerful sympathy rally bid as well, surging over 20% on massive volumes before getting temporarily halted. The meme stock comeback had arrived in full force.

Gill’s outsize position punched far above GameStop’s relatively small $7 billion market cap. Analysts noted the dramatic price impact stemmed from the stock’s concentrated short position, which got pulverized as the fortunes quickly shifted.

The sudden lurch higher put short sellers covering their losing bets on a pace to absorb nearly $1 billion in losses, according to analytics firm Ortex. GameStop once again became the most frenzied trading name across no-fee retail platforms like Robinhood (HOOD).

Longtime GameStop investors flooded Reddit forums like WallStreetBets and Superstonk with jubilant scenes. Rocket emojis and feverish rallying cries echoed the legendary meme stock heydays of 2021 as the “diamond hands” crowd smelled redemption.

However, some analysts cautioned that chasing GameStop’s vertigo-inducing rally carried substantial risks. The company continues grappling with operational challenges like slowing sales and a customer shift away from physical games toward digital downloads and streaming.

Still, the meme mania machine may be too powerful to stop now that it has been reactivated by its celebrity mascot. GameStop raised $933 million last month from a stock sale, taking advantage of May’s initial retail resurgence to fortify its turnaround ambitions.

While May’s hype dissipated quickly without broad staying power, the same explosive ingredients powering 2021’s mania remain in place today – and have only intensified with Gill’s outsized position. GameStop’s short interest spiked to nosebleed levels, leaving bearish traders acutely vulnerable to getting blown out by a sustained rally.

Those dynamics set the stage for an epic rematch between the “diamond hands” unleashed and hedge funds caught flat-footed. Redemption beckons for the OG meme crowd still down on their initial GameStop bets. Meanwhile, a new generation of retail traders is getting initiated into the frenzy, enticed by visions of generational wealth on a lucky long-shot wager.

There are no guarantees the meme stock fever lasts. But the tantalizing combination of high short interest, heavy retail buy interest, and now the return of an idolized icon like Roaring Kitty has all the makings of another wild speculative blowoff. The opening act of 2021’s wildest stock story may ultimately prove just the warmup before a shocking meme stock encore too insane to script.

Release – Conduent Recognized as a Leader in 2024 NelsonHall Report on Multi-Process HR Transformation Services

Posted on May 31, 2024May 31, 2024 by aweinsoff@channelchek.com

Research News and Market Data on CNDT

MAY 31, 2024

FLORHAM PARK, N.J. — Conduent Incorporated (Nasdaq: CNDT), a global technology-led business solutions and services company, today announced that NelsonHall, a global analyst firm, has named the company a market leader in the 2024 NelsonHall Evaluation and Assessment Tool (NEAT) for Multi-Process HR Transformation Services for Large Enterprises. This year’s NelsonHall NEAT evaluates participants across a range of criteria and business situations in specific areas of capability, company focus, and geographic coverage.

“Conduent has proven capabilities and well-established HR operational expertise in the Large Enterprise market segment, where 80% of its business supports organizations with over 15,000 employees,” said Liz Rennie, HR Technology and Services Research Director at NelsonHall. “It delivers digital transformations with AI, automation, optimization, engagement, and accuracy, and brings ongoing operational refinements in areas such as employee experience and omni-channel digital solutions. Conduent’s partnership approach and delivery expertise are well-suited to supporting the transformation of complex and large organizations.”

For Large Enterprise Focus, this year’s NEAT report recognizes Conduent for:

The breadth of its Human Capital Solutions, including HR administration, global payroll data management services, benefits administration, and learning services;
Ability to drive global processes and support products such as HRO-in-a-Box, with more than 120 globally configurable and digitally enabled processes spanning the HR lifecycle (from recruitment to retirement);
Investment in front-end proprietary technology with a design approach that uses personas to drive personalization. Proprietary applications include Life@Work Connect, chat automation and real-time dashboards with program analytics and service levels;
Capability to serve clients on leading Cloud HCM platforms, including Oracle Cloud, SAP SuccessFactors, and Workday; and
CX approach to employee experience supported by an employee-centric delivery model.

“As NelsonHall noted, Conduent remains committed to providing our HR clients with solutions that are grounded in leading digital HR technology so that HR functions can perform better, while also increasing employee engagement and satisfaction,” said Jeff Weiner, Vice President and General Manager of Human Capital Solutions at Conduent. “NelsonHall’s recognition is a great affirmation that the work and investments we are putting into our offerings and delivering to our clients is positively impacting the employee’s experience and is a differentiator when HR teams need to select a partner.”

NelsonHall defines leaders as providers that exhibit a high capability relative to their peers to deliver both immediate benefit and future client requirements. In addition to Large Enterprise Focus, Conduent was also a “Leader” in Overall, Efficiency Focus, Europe Focus, Multi-Country Focus and North America Focus in this year’s NelsonHall NEAT Report. Earlier this year NelsonHall named Conduent a leader in HR Benefits Administration.

To read the custom report of Conduent’s evaluation in the 2024 NelsonHall NEAT Report, visit https://insights.conduent.com/reports/mphr-transformation-neat-report.

About NelsonHall

NelsonHall is the leading global analyst firm dedicated to helping organizations understand the ‘art of the possible’ in digital operations transformation. With analysts in the U.S., U.K., Continental Europe, and Asia, NelsonHall provides buy-side organizations with detailed, critical information on markets and vendors (including NEAT assessments) that helps them make fast and highly informed sourcing decisions. And for vendors, NelsonHall provides deep knowledge of market dynamics and user requirements to help them hone their go-to-market strategies. NelsonHall’s analysis is based on rigorous, all-original research, and is widely respected for the quality and depth of its insight.

About Conduent

Conduent delivers digital business solutions and services spanning the commercial, government and transportation spectrum – creating valuable outcomes for its clients and the millions of people who count on them. The Company leverages cloud computing, artificial intelligence, machine learning, automation and advanced analytics to deliver mission-critical solutions. Through a dedicated global team of approximately 59,000 associates, process expertise and advanced technologies, Conduent’s solutions and services digitally transform its clients’ operations to enhance customer experiences, improve performance, increase efficiencies and reduce costs. Conduent adds momentum to its clients’ missions in many ways including disbursing approximately $100 billion in government payments annually, enabling 2.3 billion customer service interactions annually, empowering millions of employees through HR services every year and processing nearly 13 million tolling transactions every day. Learn more at www.conduent.com.

Note: To receive RSS news feeds, visit www.news.conduent.com. For open commentary, industry perspectives and views, visit http://twitter.com/Conduent, http://www.linkedin.com/company/conduent or http://www.facebook.com/Conduent.

Trademarks
Conduent is a trademark of Conduent Incorporated in the United States and/or other countries. Other names may be trademarks of their respective owners.

Media Contacts

LISA PATTERSON

Conduent

lisa.patterson@conduent.com

+1-816-305-4421

GILES GOODBURN

Conduent

ir@conduent.com

+1-203-216-3546

Release – Data And Safety Monitoring Board Approves Simultaneous Enrollment In Cohort 3 And Phase 2 Initiation In OCU410 ArMaDa Study For Geographic Atrophy

Posted on May 31, 2024May 31, 2024 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

May 31, 2024

Established Medium Dose as Safe and Tolerable Dose in Current OCU410 Clinical Trial
DSMB Recommends Continuing with High-Dose Cohort Dosing with Concurrent Phase 2 Dosing

MALVERN, Pa., May 31, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced a positive outcome of the Data and Safety Monitoring Board (DSMB) Review for its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV5-hRORA)—a modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). GA affects approximately 2-3 million people in the U.S. and Europe combined.

Six subjects with GA were dosed in the Phase 1/2 clinical trial to date—three subjects were dosed with the low dose and three subjects were dosed with the medium dose. An additional three patients will be dosed with the high dose of OCU410 in the dose-escalation phase.

“The DSMB has recommended to proceed with dosing subsequent GA subjects with the high dose of OCU410 in the dose-expansion phase of the study and concurrently initiate Phase 2 dosing,” said Dr. Peter Chang, MD, FACS, DSMB Chair for the OCU410 clinical trial. “No serious adverse events (SAEs) related to OCU410 have been reported to date in both low- and medium-dose cohorts. I believe that this marks a critical next step towards determining the maximum tolerated dose for OCU410 and is an important milestone for its clinical development.”

“We are delighted to report a second positive DSMB recommendation for the treatment of GA, which significantly builds on the favorable safety and tolerability profile exhibited by OCU410,” said Huma Qamar, MD, MPH, CMI, Chief Medical Officer of Ocugen. “We are very enthusiastic about the potential of OCU410 as a potential one-time treatment for GA with a single sub-retinal injection. The currently approved treatments for GA target only the complement pathway and require approximately 6-12 intravitreal injections annually. OCU410 addresses multiple pathways causing dAMD, including complement, lipid metabolism, inflammation, and oxidative stress, providing long-term benefit to patients.”

The ArMaDa clinical trial will assess the safety and efficacy of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels [low dose (2.5×10¹⁰ vg/mL), medium dose (5×10¹⁰ vg/mL), and high dose (1.5 ×10¹¹ vg/mL)]. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups or to an untreated control group.

About dAMD and GA
dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula. The macula is the part of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function and central vision impairment. dAMD accounts for 85-90% of the total AMD population.

About OCU410
OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA (ROR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role as well as inhibiting the complement system in in-vitro and in-vivo (animal model) studies. These results demonstrate the ability for OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of GA.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
Tiffany.Hamilton@ocugen.com

Virtual Therapeutics Levels Up in Digital Mental Health With $276M Akili Deal

Posted on May 31, 2024May 31, 2024 by slightbourne@noblecapitalmarkets.com

One of the pioneering players in applying video game technology to treating mental health conditions is going all-in on its digital therapeutic ambitions. Virtual Therapeutics announced Monday it has struck a deal to acquire Akili, Inc. in an all-cash transaction valuing the digital therapeutics firm at $276 million.

The acquisition marks a bold consolidation move as Virtual Therapeutics aims to establish itself as a diversified leader in the rapidly evolving digital health landscape. Akili shareholders will receive $0.4340 per share under the terms of the agreement, representing an 85% premium to the stock’s closing price in late April before a strategic review was announced.

Virtual Therapeutics has built a portfolio of virtual reality and immersive game experiences explicitly designed to provide mental health and cognitive fitness solutions. By adding Akili’s clinically-validated mobile software products to its platform, the combined company can offer a multi-modal suite of digital therapeutic offerings across multiple therapeutic areas.

For Akili investors, the all-cash bid comes as a welcome event after a turbulent stretch for the newly-public company. Shares had plunged over 80% from their 2022 IPO price amid slower-than-expected uptake for its flagship ADHD treatment. The $276 million deal price provides Akili shareholders with a rare exit opportunity in the cash-burning digital health space.

Founded in 2011, Boston-based Akili pioneered a new category of medicine it calls “digital therapeutics” – video game-like software programs prescribed by doctors that are clinically validated to treat medical conditions directly through cognitive engagement and video inputs. Its lead product, EndeavorRx, was cleared by the FDA in 2020 as a treatment for children with ADHD.

Take a moment to discover more emerging growth biotechnology companies by taking a look at Noble Capital Markets’ Research Analyst Robert LeBoyer’s coverage list.

Virtual Therapeutics has been taking a different tack, creating visually-rich, immersive game worlds as mental health interventions for conditions like depression, anxiety, PTSD and cognitive decline. The two approaches could prove complementary, with Akili’s mobile experiences providing one delivery mechanism and Virtual Therapeutics’ VR worlds offering an alternative modality.

Combining platforms may allow the merged company to deliver a truly multi-channel digital therapeutic offering spanning mobile, console and virtual reality environments. Cost synergies from eliminating redundancies in technology, R&D and sales infrastructure could also drive improved profitability over time.

For Virtual Therapeutics CEO and co-founder Dan Elenbaas, the Akili merger represents a major milestone in his mission to “bring behavioral health services to as many patients as possible” through engaging, accessible digital experiences. With clinical validation and regulatory clearance already in hand for Akili’s products, the road to scaling distribution and driving adoption may become clearer.

Weighing the deal’s benefits, BTIG analyst Mark Westbrook called the transaction “highly complementary” and stated it positions Virtual Therapeutics as a “clear leader” in delivering validated digital mental health solutions through novel experiential mediums like gaming.

While the digital therapeutics space is still in its infancy, the Virtual Therapeutics-Akili merger creates a formidable platform anchored by real-world clinical data and evidence. Akili gets taken private at a meaningful premium, while Virtual Therapeutics absorbs validated products to accelerate growth in its core mission of delivering modern, scalable solutions to the mental health crisis.

For healthcare investors seeking new frontiers, the combined digital mental health company resulting from this deal could be an enticing way to capitalize on gaming technology being repurposed for medical applications. Virtual reality video games may be just what the doctor ordered.

Tonix Pharmaceuticals (TNXP) – Tonmya Presentations From Previous and Upcoming Trials

Posted on May 31, 2024May 31, 2024 by cpereira@noblefcm.com

Friday, May 31, 2024

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Presentations On Long COVID Trial, Upcoming PTSD Trial. Tonix presented data from its Phase 2 PREVAIL trial testing Tonmya, previously TNX 102 SL, at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting. The data showed improvement in symptoms that we believe support findings from Phase 3 trials in fibromyalgia. A poster presentation detailed design of an upcoming study in Acute Stress disorders after automobile accidents, expected to begin in 2Q24.

PREVIAL Data Showing Improvement In Symptoms. The study was designed as a proof-of-concept in Long COVID. Although the primary endpoint of multi-site pain reduction after 14 weeks was not met, the treatment group showed measures of effect size that met prespecified criteria for further evaluation. The study showed improvements in fatigue, sleep quality, cognition function, disability, and Patient Global Impression of Change. We believe these measures are consistent with effects seen in the Phase 3 RELIEF and RESILIENT trials.

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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

MustGrow Biologics Corp. (MGROF) – Waiting for the Revenue to Come

Posted on May 31, 2024May 31, 2024 by cpereira@noblefcm.com

Friday, May 31, 2024

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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First Quarter Results. MustGrow reported zero revenue in the quarter and a net loss of CAD$1.0 million or a loss of $0.02 per share. We estimated revenue of CAD$1,000 and a net loss of CAD$1.2 million or a loss of $0.02 per share. We expect similar revenue performance until the fourth quarter of the 2024 fiscal year when TerraSante sales are expected to begin.

Cash Flow/Capital Use. MustGrow had cash used in operating activities of CAD$931,372, similar to last year at CAD$912,387. The Company had cash and cash equivalents of CAD$5.9 million as of March 31, 2024. Barring any revenue generation, we estimate an approximate 18-month runway before needing new capital.

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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

Hemisphere Energy (HMENF) – Steady quarter sets the company up for future growth

Posted on May 31, 2024May 31, 2024 by cpereira@noblefcm.com

Friday, May 31, 2024

Michael Heim, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.

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Hemisphere Energy reported production results, pricing, and costs in line with expectations. The company remains on track to meet or beat management guidance. With production and oil prices rising, we expect cash flow and earnings to improve in upcoming quarters.

The company is actively drilling, including in a new area. Hemisphere drilled five wells during the quarter which should lead to production growth. Current production has already reached peak levels. The recently acquired property Marsden play represents a step out of current production and could be an important area for future growth.

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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

Bit Digital (BTBT) – Riot Platforms Goes Public With Bitfarms Offer

Posted on May 31, 2024May 31, 2024 by cpereira@noblefcm.com

Friday, May 31, 2024

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Riot’s Offer. Riot Platforms went public with a proposal to acquire all of the outstanding shares of Bitfarms Ltd. The initial April 22nd private proposal was rejected by Bitfarms’ Special Committee of the Board. Riot Platforms also announced that it accumulated a 10% stake in the Company and is now its largest shareholder. With the stake, Riot intends to requisition a Special Meeting of Bitfarms’ shareholders to add new directors to Bitfarm’s Board following its Annual General and Special Meeting on May 31, 2024.

Proposal Details. The offer from Riot is for $2.30 per share, an approximately 20% premium to Bitfarms’ closing price of $1.92 as of April 19, 2024, the day before Riot’s private proposal. The proposal results in a total equity value of $950 million.

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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

Tech Sell-Off Hits Broader Stock Market

Posted on May 31, 2024May 31, 2024 by slightbourne@noblecapitalmarkets.com

After a torrid five-week run higher, Wall Street took its foot off the gas this week as investors moved to book some profits. The S&P 500 dropped 1.8% over the last five sessions, ending an impressive stretch that saw the broad index rally over 6% since late April.

At the core of this week’s pullback was a cooldown in red-hot technology stocks benefiting from the artificial intelligence frenzy. Semiconductor giant Nvidia, whose blowout earnings last week turbocharged the AI trade, shed over 9% this week as traders moved to cash in some of those monster gains.

Other mega cap tech leaders like Microsoft, Amazon, and Alphabet also gave back ground, contributing to a 2.4% weekly slide for the Nasdaq Composite. With Big Tech serving as a weight on the market’s shoulders, the venerable Dow Jones Industrial Average wasn’t spared either – the blue-chip index dropped over 2% itself.

The downshift marked an overdue pause that refreshed for the often overly-exuberant market. After storming nearly 15% off the lows over the previous seven weeks, a little air had to come out of the balloon, even with economic data continuing to hold up.

On the economic front, the core Personal Consumption Expenditures (PCE) reading rose 2.8% year-over-year in April, slightly exceeding estimates. While inflation remains stubbornly high, the lack of a major upside surprise helped soothe fears of the Fed needing to pivot towards an even more aggressive policy stance.

The underlying commodity and service costs feeding into the PCE suggest inflation could start to moderate in the second half of 2023. That aligns with current Fed forecasts projecting two more 25 basis point rate hikes before calling it quits on this tightening cycle.

Assuming the Fed can stick the landing without snuffing out economic growth, conditions could remain conducive for further equity upside. History shows the S&P 500 tends to bottom around six months before the end of a tightening cycle – and rally sharply in the following 12 months.

This week’s dip may have seemed like an ominous turn, but it really just returned the major indexes back in line with the performance of other segments of the market. The Russell 2000 small-cap index and Russell 3000 representing the entire U.S. equity market have been lagging the S&P 500’s advance.

Over the past month, the Russell 3000 is up a more modest 2.8% versus a 5.2% gain for the big-cap dominated S&P 500. Small-caps as represented by the Russell 2000 have fared even worse with a 1.4% advance over that span.

Analysts pointed out small-caps have struggled to sustain upside momentum. Despite bouncing back from October’s lows, the Russell 2000 is still down 6% year-to-date versus a 10% rise for the large-cap Russell 1000.

Higher financing costs, softer economic growth prospects, and the fading benefits of 2022’s rally could continue to weigh on smaller stocks in the second half.

If large-cap tech remains under pressure, it could help narrow the performance gap – with the Russell mega-caps ceding some of their market-leading gains. But for now, most of Wall Street appears comfortable viewing this week’s pullback as simply clearing the way for the next move higher.

After all, some long-overdue profit-taking and consolidation can ultimately be healthy, helping reset overbought conditions and set the stage for sustained upside.