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Release – SelectQuote’s SelectRx Pharmacy to Open a State-of-the-Art Third Fulfillment Center in Olathe, Kansas, to Support Rapid Growth

Posted on September 4, 2024September 4, 2024 by aweinsoff@channelchek.com

09/04/2024

OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT) today announced that SelectRx, the company’s full-service medication management pharmacy that serves all 50 states, will open a third fulfillment facility in Olathe, Kansas, to serve its rapidly expanding customer base, alongside its existing facilities in Monaca, Pennsylvania, and Indianapolis, Indiana.

SelectQuote launched the SelectRx business in 2021 as part of its Healthcare Services Division after acquiring two smaller pharmacy operations. In just over three years, SelectRx has grown its membership from under 5,000 to over 75,000 members who receive regular prescription shipments in adherence-friendly packaging. The new 54,000 square foot state-of-the-art facility at 404 W. Frontier Lane in Olathe, Kansas, is expected to open during the first half of calendar 2025 and should significantly expand the pharmacy’s capacity.

SelectQuote plans to add over 50 new positions at the location and is seeking experienced pharmacists, pharmacy fulfillment technicians (to assist in filling, processing, and shipping prescriptions), and various leadership and support roles such as shipping and inventory management, facilities management and information technology.

In 2023, SelectRx was recognized as a Patient-Centered Pharmacy Home (PCPH) by The Compliance Team. PCPH is based on TCT’s CMS-recognized Patient-Centered Medical Home program, which puts special emphasis on health maintenance, preventative screening, medication management, multi-specialty medical services, patient experience reporting, and benchmarking for chronically-ill patients.

SelectQuote CEO Tim Danker commented, “We are thrilled with the rapid growth of our SelectRx business over the past three years. With this new facility, we will be able to extend this highly convenient and adherence-friendly pharmacy solution to many more Seniors who can benefit from it. We are also thrilled to build out this beautiful new facility in our home market of Kansas City.”

About SelectQuote:

Founded in 1985, SelectQuote (NYSE: SLQT) provides solutions that help consumers protect their most valuable assets: their families, health, and property. The company pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads.

With an ecosystem offering high touchpoints for consumers across Insurance, Medicare, Pharmacy, and Value-Based Care, the company now has four core business lines: SelectQuote Senior, SelectQuote Healthcare Services, SelectQuote Life, and SelectQuote Auto and Home. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a specialized medication management pharmacy, and Healthcare Select which proactively connects its members with best-in-class healthcare services that fit each member’s unique healthcare needs. The platform improves health outcomes and lowers healthcare costs through proactive engagement and access to high-value healthcare solutions.

Investor Relations:
Sloan Bohlen
877-678-4083
investorrelations@selectquote.com

Media:
Matt Gunter
913-286-4931
matt.gunter@selectquote.com

Source: SelectQuote, Inc.

Release – GoHealth Acquiring e-TeleQuote, Strengthening Position as Leading Medicare Insurance Marketplace

Posted on September 4, 2024September 5, 2024 by aweinsoff@channelchek.com

Research News and Market Data on GOCO

Sep 04, 2024 at 7:00 AM EDT

Investment further expands industry-leading shopping, enrollment, and engagement platform, delivering a differentiated experience and driving high quality outcomes while ensuring peace of mind in Medicare consumers’ healthcare decisions.

CHICAGO and CLEARWATER, Fla., Sept. 04, 2024 (GLOBE NEWSWIRE) — GoHealth, Inc. (Nasdaq: GOCO), a leading health insurance marketplace, today announced that it entered into a purchase and subscription agreement which will ultimately lead to the acquisition of e-TeleQuote Insurance, Inc., a distinguished name in the Medicare insurance marketplace. The transaction is expected to close on September 30, 2024. This strategic move represents a significant milestone in GoHealth’s mission to deliver unparalleled consumer-centric solutions while reinforcing the companies’ shared values of integrity, empathy, and accountability.

The investment in e-TeleQuote aligns seamlessly with GoHealth’s strategic vision and commitment to enhancing consumer experiences through innovation and operational excellence. Both companies bring to the table a deep reservoir of industry expertise and a complementary set of strengths that will drive mutual growth and deliver even greater value to consumers, especially as the upcoming benefit season expects to bring significant disruption and high demand for a high-quality shopping experience for Medicare consumers.

Complementary Attributes for Enhanced Value
GoHealth and e-TeleQuote share a dedication to putting consumers at the center of their operations. “GoHealth’s scale, proprietary technology and operational excellence combined with e-TeleQuote’s established talent and high-quality track record will create a mutually accretive relationship poised to drive better outcomes for and meet the evolving needs of our Medicare consumers,” said Vijay Kotte, CEO of GoHealth.

Consumer-First Orientation
“At the heart of this transaction is a shared commitment to a consumer-first approach. Both GoHealth and e-TeleQuote have consistently demonstrated a deep understanding of and responsiveness to consumer needs. We are excited to tap into the power of the proprietary technology at GoHealth, including the PlanFit Checkup, which will better serve our consumers while driving increased efficiency and effectiveness in choosing the Medicare plan that best meets their needs. By combining our resources and expertise, we are poised to collectively elevate our consumer experience and deliver even better tailored solutions that prioritize the well-being of our consumers,” said Craig Uchytil, CEO of e-TeleQuote.

Looking Ahead
“As we embark on this exciting new chapter, we remain committed to a seamless integration process that prioritizes the interests of our customers, team members, and stakeholders. We are confident that this acquisition will not only strengthen our market position but also enhance our ability to deliver exceptional value and service not only in this upcoming Annual Enrollment Period but for years to come,” said Kotte.

Learn more at www.GoHealth.com

About GoHealth, Inc.
GoHealth is a leading health insurance marketplace and Medicare-focused digital health company. Enrolling in a health insurance plan can be confusing for customers, and the seemingly small differences between plans can lead to significant out-of-pocket costs or lack of access to critical medicines and even providers. GoHealth combines cutting-edge technology, data science and deep industry expertise to build trusted relationships with consumers and match them with the healthcare policy and carrier that is right for them. Since its inception, GoHealth has enrolled millions of people in Medicare plans and individual and family plans. For more information, visit https://www.gohealth.com.

About e-TeleQuote Insurance, Inc.
e-TeleQuote is a Medicare Insurance Marketplace which specializes in helping Medicare Beneficiaries compare Medicare Advantage and Medicare Supplement plans from top carriers and enroll in the plan that’s right for them.

Forward-Looking Statements
This release contains forward-looking statements. 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, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release may be forward-looking statements. Statements regarding our future results of operations and financial position, business strategy and plans and objectives of management for future operations, including, among others, statements regarding our expected growth, investment plans and business transformation are forward-looking statements.

In some cases, you can identify forward-looking statements by terms, such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.

These forward-looking statements speak only as of the date of this release and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including important factors described in the section titled “Risk Factors” in our 2023 Form 10-K, and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, and in our other filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it is made, and, except as otherwise required by law, we do not undertake any obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise. New factors emerge from time to time, and it is not possible for us to predict which will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

Media Inquiries
pressinquiries@gohealth.com

Investor Relations
jshave@gohealth.com

This press release was published by a CLEAR® Verified individual.

Release – Eledon Announces Completion of Enrollment in Phase 2 BESTOW Clinical Trial Assessing Tegoprubart for Prevention of Organ Rejection in Kidney Transplant Patients

Posted on September 4, 2024September 4, 2024 by aweinsoff@channelchek.com

Research News and Market Data on ELDN

September 4, 2024

Enrollment Completed Four Months Ahead of Schedule

IRVINE, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that it has successfully completed enrollment for its Phase 2 BESTOW clinical trial, which is designed to assess the safety and efficacy of its investigational immunosuppression therapy tegoprubart for the prevention of organ rejection in patients undergoing kidney transplantation. The trial reached its target enrollment of 120 participants approximately four months earlier than originally planned.

“We are very pleased to achieve this critical milestone ahead of schedule in our BESTOW trial,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The accelerated pace of enrollment reflects the strong interest among both clinicians and patients in new innovative therapies that have the potential to improve outcomes in kidney transplantation compared to current standard of care immunosuppression regimens. We are proud to be leading the effort to transform the prevention of organ rejection and based on the early completion of enrollment, we now anticipate reporting top-line results for the BESTOW trial in the fourth quarter of 2025.”

BESTOW, a multicenter, two-arm, active comparator clinical study, enrolled 120 participants undergoing kidney transplantation at sites in North America, Europe and Latin America to evaluate the safety, pharmacokinetics, and efficacy of tegoprubart, an anti-CD40 ligand antibody, compared to the calcineurin inhibitor tacrolimus. The study’s primary objective is to assess graft function at 12 months post-transplant, as measured by estimated glomerular filtration rate (eGFR), in participants treated with tegoprubart compared to tacrolimus. Research has shown that better graft function as assessed by eGFR has been associated with improved long-term graft survival following kidney transplantation.

“Completing enrollment in the Phase 2 BESTOW trial is a significant achievement for our team and, more importantly, for the transplant community,” said Steve Perrin, Ph.D., Chief Scientific Officer and President of Eledon. “It is a testament to the strong collaboration with our clinical sites and the enthusiasm within the community for advances in immunosuppression therapy, an area of research that has not seen major therapeutic innovation in decades. We are deeply grateful to the patients, their families, and the clinical teams for their continued support in advancing this important study.”

The BESTOW trial builds upon results from Eledon’s ongoing Phase 1b trial presented at the American Transplant Congress (ATC) in June 2024, and further demonstrates that tegoprubart has the potential to provide kidney transplant recipients with a safe and effective alternative to calcineurin inhibitors, which are often associated with side effects such as hyperglycemia, new onset diabetes, hypertension, or tremors. Eledon plans to continue advancing its tegoprubart clinical program with the goal of offering a new standard of care immunosuppression therapy for organ transplant patients.

Eledon is currently conducting the Phase 2 BESTOW trial (NCT05983770), the Phase 1b trial (NCT05027906), and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter/X

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with kidney transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Source: Eledon Pharmaceuticals, Inc.

OpenAI Co-founder Ilya Sutskever’s New AI Venture SSI Raises $1 Billion to Ensure Safe Superintelligence

Posted on September 4, 2024September 4, 2024 by slightbourne@noblecapitalmarkets.com

Key Points:
– SSI, co-founded by Ilya Sutskever, raises $1 billion, valuing the startup at $5 billion.
– The company focuses on developing safe AI that surpasses human capabilities.
– Top investors like Andreessen Horowitz and Sequoia Capital back the project.

Safe Superintelligence (SSI), the latest venture from OpenAI’s former chief scientist Ilya Sutskever, has made a significant splash in the AI world by securing $1 billion in funding just three months after its inception. With a valuation of $5 billion, SSI aims to develop artificial intelligence systems that are not only more powerful than current models but are also designed with safety and ethical considerations at the forefront.

SSI’s funding round saw participation from top-tier venture capital firms such as Andreessen Horowitz, Sequoia Capital, DST Global, and SV Angel. The company’s focus on AI safety—a hotly debated topic in the industry—has attracted significant interest, especially as concerns grow about the potential for rogue AI systems to cause harm. Sutskever’s new venture promises to prioritize safe AI development, a move that aligns with the increasing regulatory scrutiny faced by AI companies worldwide.

The startup, which currently operates with a small team split between Palo Alto, California, and Tel Aviv, Israel, plans to use the newly acquired funds to build its computing power and recruit top-tier talent. This strategic approach underscores SSI’s commitment to creating a team of highly trusted and skilled researchers and engineers who share the company’s mission of developing safe AI.

Sutskever’s decision to leave OpenAI and start SSI was driven by his vision to tackle a different aspect of AI development—one that diverges from the path he was previously on. His departure from OpenAI earlier this year followed a series of internal conflicts, including the controversial removal and subsequent reinstatement of OpenAI CEO Sam Altman. This turn of events diminished Sutskever’s role at OpenAI, leading to his departure and the eventual formation of SSI.

Unlike OpenAI’s unconventional corporate structure, which was designed with AI safety in mind but also led to internal turmoil, SSI operates as a traditional for-profit company. This structure allows SSI to focus more on its mission without the complications that arise from a more complex corporate governance system.

SSI’s CEO Daniel Gross, along with Sutskever and Daniel Levy, a former OpenAI researcher, are steering the company toward becoming a leader in AI safety. The team is committed to building AI systems that not only advance the technology but also ensure that these systems remain aligned with human values. This focus on ethics and safety is becoming increasingly important as AI systems continue to evolve and integrate into more aspects of everyday life.

SSI’s approach to AI development includes rigorous vetting of potential hires to ensure they align with the company’s values. Gross emphasized the importance of recruiting individuals with “good character” who are motivated by the work rather than the hype surrounding AI.

As the AI industry continues to grow, SSI’s emphasis on safety could set it apart from other AI startups. The company plans to partner with cloud providers and chip manufacturers to meet its computing needs, but it has yet to announce specific partnerships. Sutskever’s early advocacy for scaling AI models laid the groundwork for many of the advances seen today, and his new approach at SSI suggests a continuation of this innovative mindset—albeit with a different focus.

With $1 billion in funding and the backing of some of the most prominent venture capitalists, SSI is poised to make a significant impact in the AI industry. The company’s focus on safe superintelligence could pave the way for new advancements that are not only powerful but also ethically sound.

Unicycive Therapeutics (UNCY) – NDA Submission Keeps OLC Approval On Expected Timeline

Posted on September 4, 2024September 4, 2024 by cpereira@noblefcm.com

Wednesday, September 04, 2024

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.

Unicycive Announced Submission Of The OLC Application For Approval. Unicycive has announced that its New Drug Application (NDA) for its phosphate binder OLC (oxylanthanum carbonate) has been submitted to the FDA. This is consistent with our expectations after data from the last clinical study showing efficacy in treating high phosphate levels in chronic kidney disease (CKD) patients on dialysis. We continue to anticipate product approval in 2Q25.

We Believe Dosing and Efficacy Could Make OLC The Leading Phosphate Binding Drug. OLC was developed with proprietary nanoparticle technology to reduce the daily number of pills to just one three times a day for a full dose. This gives an advantage over other phosphate binders, which require 9 to 12 pills each day. Its formulation is based on lanthanum, the active entity in the approved drug Fosrenol. We expect this to be a strong advantage for OLC.

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*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.

Century Lithium Corp. (CYDVF) – Getting Close to Producing Battery Grade Lithium On-Site

Posted on September 4, 2024September 4, 2024 by cpereira@noblefcm.com

Wednesday, September 04, 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.

Lithium carbonate production at the pilot plant. Century Lithium successfully added a lithium carbonate stage at the company’s lithium extraction facility which is part of the company’s Angel Island Mine project. Previously, concentrated lithium solutions from the pilot plant were treated by Saltworks Inc. at their facility in Richmond, British Columbia to produce samples of battery grade lithium carbonate. Century Lithium is now able to do this at the pilot plant and demonstrate it has an end-to-end process to produce lithium carbonate.

Assay results. Century Lithium released assay results from the first lithium carbonate produced at the newly commissioned lithium carbonate stage at the company’s lithium extraction facility. Assays received for the initial five individual lots of lithium carbonate produced indicated purity of the lithium carbonate ranging from 98.2% to 99.2%. While lithium carbonate greater than 99.5% purity is typically considered battery grade, the company has identified steps to improve the purity level.

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Release – Century Lithium Produces Lithium Carbonate Onsite At Pilot Plant

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

Research News and Market Data on CYDVF

August 6, 2024 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (Century Lithium or the Company) is pleased to report the successful addition of a lithium carbonate stage at the Company’s Lithium Extraction Facility (Pilot Plant) in Amargosa Valley, Nevada, USA, part of the Company’s 100%-owned Angel Island Mine (the Project). Prior to this addition, concentrated lithium solutions from the Pilot Plant were treated by Saltworks Inc. at their facility in Richmond B.C. where samples of battery quality lithium carbonate were produced. During the first days of startup of the lithium carbonate stage, Century’s team at the Pilot Plant successfully treated 200 liters of concentrated lithium solution and produced 20 kg of high-grade lithium carbonate onsite.

“At this point in time, the ability to make lithium carbonate at our Pilot Plant is an important step forward, in line with recommendations from our recently completed Feasibility Study” commented President and CEO Bill Willoughby. “The drop in lithium prices over the last year has taken a toll on the share price of all lithium companies. Despite the downturn, domestic production is still key to the security of supply in the U.S. While it is becoming well known that a vast amount of lithium is contained within the claystone deposits of Nevada, the benefit in unlocking these resources is the ability to produce a battery quality lithium product onsite and thereby reducing or eliminating the need for downstream processing.”

The Company continues work at the Pilot Plant, utilizing the Company’s patent-pending process for chloride leaching combined with Direct Lithium Extraction (DLE) to generate data as the Company works to identify further technological breakthroughs to make the extraction of lithium from clay more economic. Adding the lithium carbonate stage at the Pilot Plant is one of the recommendations made in the Feasibility Study, not only to further demonstrate that battery quality lithium carbonate can be made, but to better understand and minimize the recycle streams from the DLE stage through to final product in the process. With the assistance of engineers from Hargrove Engineers and Constructors, Century’s team configured equipment to run 40-liter batches of concentrated lithium solution though precipitation, washing and drying steps. Final assays on the lithium carbonate are pending.

Qualified Person

Todd Fayram, MMSA-QP and Senior Vice President, Metallurgy of Century Lithium is the qualified person as defined by National Instrument 43-101 and has approved the technical information in this release.

ABOUT CENTURY LITHIUM CORP.

Century Lithium Corp. is an advanced stage lithium company, focused on developing its 100%-owned Angel Island Mine in west-central Nevada, USA. Century Lithium recently completed a Feasibility Study on its Clayton Valley Lithium Project and is currently in the permitting stage, with the goal of becoming a domestic producer of lithium for the growing electric vehicle and battery storage market.

ON BEHALF OF CENTURY LITHIUM CORP.
WILLIAM WILLOUGHBY, PhD., PE
President & Chief Executive Officer

For further information, please contact:
Spiros Cacos | Vice President, Investor Relations
Direct: +1 604 764 1851
Toll Free: 1 800 567 8181
scacos@centurylithium.com
centurylithium.com

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.

Cautionary Note Regarding Forward-Looking Statements

This release contains certain forward-looking statements within the meaning of applicable Canadian securities legislation. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved” and similar expressions suggesting future outcomes or statements regarding an outlook.

Forward-looking statements relate to any matters that are not historical facts and statements of our beliefs, intentions and expectations about developments, results and events which will or may occur in the future, without limitation, statements with respect to the potential development and value of the Project and benefits associated therewith, statements with respect to the expected project economics for the Project, such as estimates of life of mine, lithium prices, production and recoveries, capital and operating costs, IRR, NPV and cash flows, any projections outlined in the Feasibility Study in respect of the Project, the permitting status of the Project and the Company’s future development plans.

These and other forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. These risks include those described under the heading “Risk Factors” in the Company’s most recent annual information form and its other public filings, copies of which can be under the Company’s profile at www.sedarplus.com. The Company expressly disclaims any obligation to update-forward-looking information except as required by applicable law. No forward-looking statement can be guaranteed and actual future results may vary materially. Accordingly, readers are advised not to place reliance on forward-looking statements or information. Furthermore, Mineral Resources that are not Mineral Reserves do not have demonstrated economic viability.

Release – Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

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

Research News and Market Data on UNCY

September 03, 2024 7:03am EDT Download as PDF

LOS ALTOS, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway.

“With this NDA submission, we are excited to be one step closer to our goal of bringing OLC to patients with chronic kidney disease who are living with hyperphosphatemia,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “We believe our data support a differentiated and best-in-class therapy that will maintain phosphate control while reducing the onerous pill burden patients currently have to manage. Over the last several months, our team has worked diligently to reach this milestone, and we are now preparing to launch OLC, if approved. We are also pleased to report that the FDA granted a waiver for the NDA application Prescription Drug User Fee Act (PDUFA) fees which is a significant savings of approximately $4 million.”

The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the specifications and practices related to chemistry, manufacturing and controls (CMC).

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.¹ The global market opportunity for treating hyperphosphatemia is expected to exceed $2.5 billion, with the United States accounting for more than $1 billion of that total². Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.

Fosrenol® is a registered trademark of Shire International Licensing BV.
¹Reason Research, LLC 2022 survey. Results here.
²Fortune Business Insights^TM, Hyperphosphatemia Treatment Market, 2021-2028

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.

Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

Source: Unicycive Therapeutics, Inc.

Released September 3, 2024

Wall Street Stumbles into September: Key Economic Data Looms Over Markets

Posted on September 3, 2024September 3, 2024 by slightbourne@noblecapitalmarkets.com

Wall Street started September on a sour note as major indexes fell more than 1%, driven by concerns over the latest U.S. manufacturing data and the anticipation of key labor market reports due later this week. The decline highlights growing investor unease about the direction of the U.S. economy and the potential actions of the Federal Reserve in the coming months.

The U.S. manufacturing sector showed modest improvement in August, rising slightly from an eight-month low in July. However, the overall trend remained weak, pointing to continued challenges within the sector. The S&P 500 industrials sector, which includes industry giants like Caterpillar and 3M, dropped over 1.6% as market participants digested the mixed signals from the manufacturing data. This decline in industrial stocks was mirrored by a significant drop in rate-sensitive technology stocks, with Nvidia leading the losses, falling 5.4%. The Philadelphia SE Semiconductor Index followed suit, losing 4.1%. Other tech heavyweights, including Apple and Alphabet, also felt the pressure, with each company’s stock declining by more than 1.6%.

Investors are now turning their attention to the labor market, with a series of reports scheduled throughout the week, culminating in Friday’s non-farm payrolls data for August. The labor market has been under increased scrutiny since July’s report suggested a sharper-than-expected slowdown, which contributed to a global selloff in riskier assets. This week’s labor data will be closely watched, as it could influence the Federal Reserve’s monetary policy decisions later this month. The Fed’s meeting is expected to provide more clarity on potential policy adjustments, especially after Chair Jerome Powell recently expressed support for forthcoming changes. According to the CME Group’s FedWatch Tool, the probability of a 25-basis point interest rate cut stands at 63%, while the likelihood of a larger 50-basis point reduction is at 37%.

Amid the broader market downturn, defensive sectors such as consumer staples and healthcare managed to post marginal gains, offering some relief to investors. In contrast, energy stocks were the worst performers, with the sector falling 3% due to declining crude prices. The drop in energy stocks underscores the volatility in commodity markets and the broader uncertainty facing investors as they navigate the current economic environment. Despite the recent setbacks, the Dow and S&P 500 have shown resilience, recovering from early August’s losses to end the month on a positive note. Both indexes are near record highs, though September has historically been a challenging month for equities.

Among individual stocks, Tesla managed to gain 0.5% following reports that the company plans to produce a six-seat version of its Model Y car in China starting in late 2025. Conversely, Boeing shares plummeted 8% after Wells Fargo downgraded the stock from “equal weight” to “underweight,” citing concerns about the company’s near-term outlook.

As the week progresses, the market will be closely monitoring labor market data and any signals from the Federal Reserve regarding future monetary policy. With the economic outlook still uncertain, investors are likely to remain cautious, weighing hopes for a soft landing against fears of a more pronounced economic slowdown.

NN Inc. (NNBR) – Some Additional Flexibility

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

Tuesday, September 03, 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.

Flexibility. On Friday, NN filed an 8-K disclosing some amendments to its term loan and ABL agreements. In essence, the amendments to each will provide the Company with additional financial flexibility, in our view. While there does not appear to be any change in interest rates, a reduction in rates is a long-term goal of management.

Term Loan. The amendment raises the amount of the Company’s allowable indebtedness – incurred in connection with the purchase or lease of fixed assets – from $20 million to $40 million, provided that no more than $26.95 million is used with respect to any sale and leaseback transaction. In addition, the amendment requires the Company to use the net cash proceeds obtained in connection with any future sale and leaseback transactions to prepay any outstanding principal indebtedness under the term loan.

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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) – Gearing Up for Sales

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

Tuesday, September 03, 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.

2Q Results. MustGrow had no revenue during the quarter. We estimated revenue of CAD$1,000. Net loss was CAD$960,209, or a loss of $0.02/sh, compared to a loss of CAD$1.2 million last year, or a loss of $0.02/sh. We estimated a net loss of $1.1 million, or a loss of $0.02/sh.

But Revenue Underway. Revenue for MustGrow’s TerraSante product is now coming in. We believe this initial revenue recognition to be an important milestone for the Company, with the product now in farmers’ hands. Management noted that sales are performing as expected, with farmers having small-scale testing of TerraSante to understand the product.

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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).

Lifeway Foods (LWAY) – Positive Momentum for Shares, Increasing Price Target

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

Tuesday, September 03, 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.

Increasing Price Target. Shares of LWAY have risen since the Company had record-breaking operating results in the second quarter. The increase in the share price, of around 15% from the announcement of second quarter results, along with the positive operating momentum of the Company pushes our target price from a previous $20 to $25.

Rise in Price. Since the second quarter results on August 13th, shares of LWAY have risen to $19.18 as of Friday’s close from $16.66. The average volume per day over the course of this time (14 days) was approximately 255,571 shares as opposed to last quarter’s 164,046. Although not all volume is positive, the positive trend indicates more investor interest in Lifeway’s story and being encouraged with the Company’s performance.

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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).

1·800·Flowers.com, Inc. (FLWS) – Why This Company Should Be On Your Radar Screen

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

Tuesday, September 03, 2024

For more than 45 years, 1-800-Flowers.com has offered truly original floral arrangements, plants and unique gifts to celebrate birthdays, anniversaries, everyday occasions, and seasonal holidays, and to deliver comfort during times of grief. Backed by a caring team obsessed with service, 1-800-Flowers.com provides customers thoughtful ways to express themselves and connect with the most important people in their lives. 1-800-Flowers.com is part of the 1-800-FLOWERS.COM, Inc. family of brands. Shares in 1-800-FLOWERS.COM, Inc. are traded on the NASDAQ Global Select Market, ticker symbol: FLWS.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Q4 results. The company reported Q4 revenue of $360.9 million, which was modestly below our estimate of $373.5 million by 3.4%. Additionally, Adj. EBITDA loss in the quarter of $8.8 million was below our estimate of negative $5.8 million. While the results were softer than expected, there were some bright spots. Notably, Q4 gross profit margin increased 130 basis points from the prior year period, which was largely attributed to lower freight and commodity costs, as well as cost saving initiatives.

Increasing revenue investments. Management indicated that it plans to step up marketing, post the upcoming elections, and will introduce new products at price points that may help to offset the lackluster sales particularly for its everyday gifting products. There has been a bifurcation of sales for its products that target its high end consumer and that for consumers that are price sensitive.

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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).