Month: June 2024

Release – Unicycive Therapeutics Achieves Study Objective in Oxylanthanum Carbonate (OLC) Pivotal Clinical Trial

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

June 25, 2024 7:30am EDT 

– Successfully Established Favorable Tolerability and Safety of OLC –

– New Drug Application (NDA) Submission Anticipated in Q3 2024 –

– Webcast and Conference Call Today at 8:30 A.M. ET –

LOS ALTOS, Calif., June 25, 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 positive results from the Oxylanthanum Carbonate (OLC) UNI-OLC-201 pivotal clinical trial with regard to both safety and tolerability endpoints. OLC 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).

The study established promising tolerability of OLC at clinically effective doses in CKD patients on hemodialysis. In terms of tolerability, OLC had a low rate of discontinuation due to adverse events (AEs) with only 5/86 patients (6%) discontinuing from the Study. Of the 5 discontinuations, 3 were treatment-related and 2 were not related to treatment. Importantly, the Company believes the low discontinuation rate for OLC compares favorably to a discontinuation rate due to AEs of 14% for Fosrenol® from its U.S. Food and Drug Administration (FDA)-approved Package Insert.

The primary endpoint was defined as the rate of discontinuations due to treatment-related AEs leading to discontinuation in the maintenance period. In the UNI-OLC-201 trial, there was only 1 discontinuation due to a treatment-related AE in the Evaluable Population (n=71), a rate of 1.4%. In the full Safety Population, a total of 3 patients discontinued due to treatment-related AEs, a rate of 3.5%.

The secondary endpoint assessing safety was also favorable as most treatment-related AEs were mild to moderate in severity and there were no treatment-related serious adverse events (SAEs) reported in the Safety Population. The treatment-related AEs reported in ≥5% of patients were diarrhea (9%) and vomiting (6%) which also compares favorably to Fosrenol and other phosphate binders on the market.

While the study was not designed to evaluate efficacy, the trial enrolled patients on stable doses of approved hyperphosphatemia medications. At baseline approximately 59% of patients had phosphate levels ≤5.5 mg/dL, the level recommended by KDOQI guidelines. After washout from the prior phosphate binders, 90% of patients were able to achieve phosphate levels ≤5.5ng/dL at the end of titration with OLC.

“We are immensely pleased with the outcome of the UNI-OLC-201 clinical trial as the results demonstrate extremely promising tolerability results in real-world dialysis patients,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “The study was well received by investigators and patients as we were able to successfully over-enroll the study with 71 evaluable patients. In addition, we were able to obtain phosphate control in 90% of the Safety Population during titration and OLC proved to be highly potent at lower doses. We would like to thank our investigators, study coordinators, and the patients who dedicated their time and energy for our clinical trial.”

Dr. Gupta continued, “We believe these favorable results confirming tolerability for OLC are the final data component needed to support submission of a New Drug Application to the FDA utilizing the 505(b)(2) regulatory pathway. The submission package will also include the previously disclosed preclinical data and the data establishing bioequivalence to Fosrenol. The encouraging performance of OLC gives us a high degree of confidence and provides potential clinical validation of OLC’s best-in-class commercial promise for patients suffering from hyperphosphatemia.”

“Based on real world evidence, approximately 40% of patients on dialysis are unable to achieve adequate serum phosphate control as defined by established KDOQI treatment guidelines1. The UNI-OLC-201 study was representative of the U.S. dialysis patient population. Uncontrolled hyperphosphatemia is an important problem for patients and physicians because it can lead to other major complications including cardiovascular disease. I am encouraged by the results from the OLC pivotal trial, and I believe that a product like OLC that improves phosphate control and reduces the number of pills could have a meaningful impact on the overall care of CKD patients on dialysis,” added Pablo Pergola, MD, PhD, Research Director, Clinical Advancement Center, Renal Associates, P.A., and principal investigator for the UNI-OLC-201 trial.

Conference Call & Webcast Details

Unicycive will host a webcast and conference call with accompanying slides today at 8:30 a.m. ET. The live and archived webcast may be accessed on the Unicycive website under the Investors section: Events and Presentations. The live call can be accessed by dialing +1 (646) 876-9923 with Meeting ID: 96518079674 and Passcode: 273069.

Presentation slides will be provided at the start of the conference call on the Unicycive website under the Investors section: Events and Presentations.

OLC-201 Data Summary

Overview

The results from the trial are focused on two patient populations: the full Safety Population and the Evaluable Population. The Safety Population (n=86) included all patients who entered titration and received at least one dose of OLC. The Evaluable Population (n=71) required a patient to have a serum phosphate level of ≤5.5 mg/dL at the end of titration and received at least one dose of OLC in the maintenance period.   

Once patients were enrolled into the trial, they went through a washout period for two weeks to clear their current phosphate binder from the body. Participants were initially dosed at 500 mg of OLC three times a day (TID) and titrated to a clinically effective dose that is defined as the dose required to achieve a serum phosphate level of ≤5.5 mg/dL. The maximum dose of OLC tested was 3000 mg/day (1000 mg TID). As a reminder, all approved phosphate binders are administered on a dose titration schedule based on the control of serum phosphate. Once titrated to a clinically effective dose, patients were then treated in a maintenance period with OLC for four weeks to evaluate tolerability.

Demographics and Enrollment Summary

In the study, 106 patients were enrolled, of which 86 patients entered titration and were followed as the Safety Population. Of the 86, 78 entered the maintenance period. Of the 78 patients that entered maintenance, 7 patients did not have phosphate control, leaving an Evaluable Population of 71 patients, exceeding the planned enrollment number of 60. Of the 86 patients, the trial enrolled 47 males and 39 females with a mean age of 62. Renvela® was the most prescribed phosphate binder for patients entering the study.

Primary Endpoint – Tolerability:

The objective of the OLC-201 trial was to evaluate the tolerability of clinically effective doses of OLC in CKD patients on dialysis. A clinically effective dose was established when a patient achieved a serum phosphate level ≤5.5 mg/dL. Tolerability was assessed based on the incidence of treatment-related AEs leading to discontinuation from the study in the maintenance period. In the OLC-201 trial, there was only 1 discontinuation due to a treatment-related AE in the Evaluable Population, a rate of 1.4%. In the Safety Population of 86 patients there were only 3 treatment-related discontinuations, a rate of 3.5%. In total, 5 patients discontinued due to AEs in the Safety Population, 3 were related to OLC and 2 were deemed unrelated to OLC.

Secondary Endpoint – Safety:

The secondary endpoint assessing safety was reported as the treatment-related AEs occurring in ≥5% of patients. The safety analysis covered all 86 patients in the Safety Population. Consistent with the AEs observed with other phosphate binders, the AEs were gastrointestinal related with diarrhea and vomiting being the most common at 9% and 6% respectively. There were no treatment-related serious adverse events (SAEs). Six patients experienced SAEs but those were deemed not related to OLC treatment. Most treatment-related AEs were mild to moderate in severity with only 2 AEs reported as severe.

Unicycive continues to assess the pharmacokinetics from this trial and those final data will be included in the NDA package.

Serum Phosphate Control

While the UNI-OLC-201 study was not designed to evaluate efficacy, the trial enrolled patients on stable doses of approved hyperphosphatemia medications. At baseline 59% of patients had phosphate levels ≤5.5 mg/dL, the level recommended by KDOQI guidelines. After washout from the prior phosphate binders, 90% of patients were able to achieve phosphate levels ≤5.5ng/dL at the end of titration with OLC. This includes the last serum phosphate levels from all patients including those that discontinued during titration: 77/86 (90%).

In addition, 69% of the 71 Evaluable Patients achieved a target serum phosphate level of ≤5.5 mg/dL at OLC doses of 1500 mg/day or lower.

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). 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.2 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.5 billion in 2023, with the United States accounting for more than $1 billion of that total.3 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.

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. As part of the clinical development program, two prior clinical studies were conducted in over 100 healthy volunteers. The first study was a dose-ranging Phase I study to determine safety and tolerability. The second study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between OLC and Fosrenol. Based on the topline results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of OLC to Fosrenol was established.

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. Topline data from the Oxylanthanum carbonate (OLC) pivotal trial is preliminary and subject to change based on further detailed analysis. 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.

Fosrenol® (lanthanum carbonate) is a registered trademark of Shire International Licensing BV.
Renvela® (sevelamer carbonate) is a registered trademark of Sanofi.

1KDOQI treatment guidelines
2Reason Research, LLC 2022 company sponsored survey. Results here.
3Fortune Business InsightsTM, Hyperphosphatemia Treatment Market, 2021-2028

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d5d3fbf1-f566-4d9c-9a33-489e7b4cf1f4

Source: Unicycive Therapeutics, Inc.

Released June 25, 2024

NN, Inc. (NNBR) – A CFO Change

Posted on by cpereira@noblefcm.com


Tuesday, June 25, 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.

A CFO Change. Yesterday, NN, Inc. announced the appointment of Chris Bohnert as Chief Financial Officer, effective June 25, 2024. Mr. Bohnert assumes the position from Mike Felcher, who will stay on as a consultant, most likely through the second quarter reporting season.

Why? In a word, experience. According to management, NN needed a “been there, done that” to of finance person and Mr. Bohnert’s background fit the bill. Mr. Bohnert had been working with NN on an advisory basis in the refinancing process and previously worked with CEO Harold Bevis at Commercial Vehicle Group (CVG). We believe his appointment will enable CEO Bevis to push for faster change, both operationally and financially.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Maple Gold Mines (MGMLF) – Restructuring Transaction Provides a Clear Path to Development

Posted on by cpereira@noblefcm.com


Tuesday, June 25, 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.

JV restructuring transaction. Maple Gold and Agnico Eagle Mines Limited (NYSE: AEM) entered into an agreement pursuant to which: 1) the existing joint venture agreement dated February 2021 between Agnico and Maple will be terminated, 2) Maple will obtain a 100% ownership interest in the Douay Gold and Joutel Gold Projects, 3) Maple will grant Agnico a 1.0% net smelter return royalty associated with the properties, and 4) Agnico Eagle will retain certain options to acquire a 50% ownership interest in the projects.

Agnico back-in option. Agnico’s option to acquire a 50% interest in the projects will be exercisable by Agnico following the closing of the restructuring transaction until 90 days following receipt of a notice from Maple Gold that its board of directors has authorized the development of a mine complex at the project. The mine will need to be supported by a preliminary feasibility study or feasibility study affirming a C$300 million net present value. If the option is exercised, Agnico will be required to make a cash payment to Maple Gold equal to 200% of expenditures incurred by Maple Gold, along with C$12 million.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Comstock Inc. (LODE) – Comstock Metals Receives Conditional Use Permit for its First Planned Industry Scale Facility

Posted on by cpereira@noblefcm.com


Tuesday, June 25, 2024

Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.

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.

Taking the next step. The company’s demonstration facility has enabled the acceleration of the design and permitting of the first industry scale facility targeting 100 thousand tons per year of waste solar panel processing capacity. Comstock Metals is engaged with major, large-scale customers for high-volume, longer-term commitments that will be able to be serviced with expanded storage capacity and a planned industry-scale site.

Conditional use permit. The Lyon County, Nevada Board of County Commissioners unanimously approved a conditional use permit for the operations and material storage of solar panels at Comstock Metals first planned industrial scale facility in Silver Springs, Nevada. The facility will serve the expanding solar industry in the western United States. Once the company demonstrated its ability to recycle and reuse 100% of the recycled materials, it accelerated permitting for the expansion, both for storage and industry-scale operations.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Novo Nordisk’s $4.1 Billion Bet on Weight Loss

Posted on by slightbourne@noblecapitalmarkets.com

In a bold move that underscores the burgeoning demand for weight loss and diabetes treatments, Danish pharmaceutical giant Novo Nordisk has announced a monumental $4.1 billion investment to construct a state-of-the-art manufacturing facility in Clayton, North Carolina. This strategic decision marks a significant escalation in the company’s commitment to increasing the supply of its blockbuster drugs, Wegovy and Ozempic, which have taken the medical world by storm.

The new 1.4 million-square-foot plant, slated for completion between 2027 and 2029, will be dedicated to the crucial tasks of filling and packaging syringes and injection pens for these game-changing medications. This expansion is not just about bricks and mortar; it represents a transformative step in Novo Nordisk’s production capabilities and its position in the competitive pharmaceutical landscape.

The timing of this investment is critical. Wegovy and Ozempic, both part of a class of drugs known as GLP-1s, have seen demand skyrocket, outpacing the company’s current production capacity. The resulting shortages have left many patients struggling to access these treatments, which have shown remarkable efficacy in managing weight and diabetes. The new facility aims to bridge this gap, potentially revolutionizing access to these sought-after therapies.

The scale of Novo Nordisk’s commitment is evident in the numbers. The company plans to invest a staggering $6.8 billion in production this year alone, a significant increase from the $4 billion invested last year. This ramping up of investment reflects not just the current demand but also the company’s bullish outlook on the future of these treatments.

The impact of this expansion extends beyond the realm of healthcare. The new facility is set to create 1,000 new jobs, adding to the 2,500 employees already working at Novo Nordisk’s existing North Carolina plants. This influx of high-quality jobs represents a significant economic boon for the region, further cementing North Carolina’s status as a hub for pharmaceutical manufacturing.

The demand for Wegovy, in particular, underscores the potential market for effective weight loss treatments. With an average of 35,000 U.S. patients starting Wegovy each week – up from 27,000 in May – the drug has clearly struck a chord in a nation grappling with an obesity epidemic. However, the current shortage of lower doses has hampered the drug’s rollout, a problem this new facility aims to address.

Novo Nordisk’s expansion is not happening in isolation. The weight loss and diabetes treatment market has become a battleground for pharmaceutical giants, with companies like Eli Lilly also investing heavily in manufacturing capacity for similar drugs. This competition is likely to drive further innovation and potentially lead to more accessible treatments for patients in the future.

The Clayton facility will join Novo Nordisk’s existing manufacturing network, which includes plants in Denmark, France, China, Japan, and several other countries. However, this significant investment in U.S. manufacturing capacity signals the company’s recognition of the importance of the American market and its commitment to serving patients in the region.

As construction begins on this new facility, the pharmaceutical industry watches with keen interest. The success of this venture could set a new standard for production capacity in the industry and potentially reshape how companies approach the manufacturing of high-demand drugs.

In the grand scheme of things, Novo Nordisk’s $4.1 billion investment is more than just an expansion of manufacturing capacity. It represents a vote of confidence in the future of weight loss and diabetes treatments, a commitment to addressing critical healthcare needs, and a strategic move to solidify the company’s position as a leader in this rapidly evolving field. As the facility takes shape over the coming years, it may well become a symbol of the transformative power of targeted pharmaceutical investment in addressing global health challenges.

$381M Alimera Acquisition Propels ANI Pharmaceuticals into New Markets

Posted on by slightbourne@noblecapitalmarkets.com

In a strategic move to bolster its position in the rare disease and ophthalmology markets, ANI Pharmaceuticals has announced its acquisition of Alimera Sciences for approximately $381 million. This transformative deal, expected to close in the third quarter of 2024, marks a significant step in ANI’s growth strategy and expansion into the global pharmaceutical landscape.

The acquisition terms include an upfront payment of $5.50 per share in cash, representing a substantial 75% premium over Alimera’s recent closing price. Additionally, Alimera shareholders will receive a contingent value right (CVR) of up to $0.50 per share, tied to the achievement of specific revenue targets in 2026 and 2027. This structure aligns the interests of both companies and incentivizes future growth.

At the heart of this acquisition are Alimera’s two key commercial products, ILUVIEN® and YUTIQ®, both targeting eye conditions such as diabetic macular edema and chronic non-infectious uveitis. These assets are expected to contribute significantly to ANI’s revenue stream, adding approximately $105 million in highly durable branded revenue. The integration of these products aligns with ANI’s recent strategic focus on ophthalmology, complementing its existing rare disease portfolio.

The deal is projected to have a substantial positive impact on ANI’s financial performance. The company anticipates high single-digit to low double-digit accretion in adjusted non-GAAP earnings per share (EPS) in 2025, with even more substantial accretion expected in subsequent years. Furthermore, ANI projects an additional $35-$38 million in adjusted non-GAAP EBITDA for 2025, including approximately $10 million in identified cost synergies.

Beyond the immediate financial benefits, this acquisition significantly expands ANI’s geographic footprint. Alimera’s established presence in European markets, including direct operations in Germany, the United Kingdom, Portugal, and Ireland, provides ANI with a springboard for international growth. The deal also brings valuable partnerships in Asia and the Middle East, further diversifying ANI’s global reach.

Strategically, this move strengthens ANI’s position in the rare disease sector, which is expected to become the company’s primary growth driver. Post-acquisition, the rare disease segment is projected to account for approximately 45% of ANI’s pro forma 2024 revenues, with robust growth potential. The transaction also leverages ANI’s existing rare disease infrastructure, creating operational efficiencies and expanding its reach to over 3,600 physicians in the ophthalmology field.

To finance the acquisition, ANI will utilize a combination of cash on hand and $280 million in committed debt financing from J.P. Morgan and Blackstone Credit & Insurance. The company anticipates a pro-forma leverage of 3.2x upon closing, with significant organic de-levering expected in 2025.

The boards of directors of both companies have approved the transaction, which now awaits customary closing conditions, including regulatory approvals and Alimera shareholder approval. Both companies have enlisted top-tier financial and legal advisors to navigate the complexities of the deal, underscoring its strategic importance.

This acquisition represents a pivotal moment for ANI Pharmaceuticals, positioning it as a stronger player in the rare disease and ophthalmology markets. By integrating Alimera’s products and expertise, ANI is set to enhance its market presence, diversify its revenue streams, and potentially accelerate the growth of its existing products, including Purified Cortrophin® Gel, in the ophthalmology sector.

As the pharmaceutical industry continues to evolve, with an increasing focus on specialized treatments for rare diseases, this strategic move by ANI Pharmaceuticals demonstrates its commitment to growth and innovation. The successful integration of Alimera Sciences could serve as a catalyst for ANI’s long-term success, benefiting patients, physicians, and shareholders alike in the rapidly advancing field of ophthalmology and rare disease treatment.

Release – Bowlero’s Summer Season Pass Hits $6 Million In Sales

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BOWL

06/24/2024

RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corp. (NYSE: BOWL) (“Bowlero” or the “Company”), one of the World’s premier operators of location-based entertainment announced today that its Summer Season Pass exceeded $6 million in sales to date, marking an all-time high in pass sales for the company with over two months worth of sales opportunity remaining. This achievement highlights the growing popularity of the Summer Season Pass and Bowlero’s commitment to delivering value and entertainment to its guests.

“Our Summer Season Pass was specifically designed to enhance the bowling experience for our guests,” said Lev Ekster, President of Bowlero Corp. “This year’s sales reflect our commitment to innovation and guest satisfaction and we are pleased to see such a positive response from the consumer this early in the season. It remains our mission to create memorable experiences for our guests, and the Summer Season Pass is a key part of that customer journey.”

The Summer Season Pass allows guests to enjoy two games of bowling every day throughout the summer, with the option to upgrade to a Premium Pass for additional perks such as 15% off food and non-alcoholic beverages, a $5 arcade card reload each visit, and use at all participating locations nationwide. With extended hours at locations over the summer months, Bowlero is guaranteeing guests have more opportunities to bowl, meeting the needs of avid bowlers and attracting new customers looking for summer activities.

This initiative offers additional benefits to the company by encouraging guests to visit Bowlero locations more frequently over the summer months, creating a consistent flow of traffic. The Summer Season Pass not only introduces a new revenue stream for the company but also expands Bowlero’s reach to a broader audience. By offering an affordable and attractive entertainment option, Bowlero can appeal to new guests, foster long-term customer relationships, and improve brand loyalty carrying that positive consumer sentiment into the fall and winter seasons.

“Our team has gone above and beyond to create an unforgettable environment for guests this summer,” said Jeff Gliner, Chief Operating Officer of Bowlero Corp. “The increased traffic from the summer pass holders will drive uptake in our updated menu offerings rolling out this summer.”

The Summer Season Pass is on sale now at www.SummerSeasonPass.com and can be redeemed through September 2, 2024.

About Bowlero Corp.

Bowlero Corporation is one of the World’s premier operators of location-based entertainment. With approximately 350 locations across North America, the Company serves more than 40 million guest visits annually through a family of brands that include Lucky Strike, Bowlero and AMF. In 2019, Bowlero acquired the Professional Bowlers Association, the major league of bowling and a growing media property that boasts millions of fans around the globe. For more information on Bowlero, please visit BowleroCorp.com.

Forward Looking Statements

Some of the statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risk, assumptions and uncertainties, such as statements of our plans, objectives, expectations, intentions and forecasts. These forward-looking statements are generally identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “confident,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on our management’s current expectations, estimates, forecasts, projections, assumptions, beliefs and information. Although management believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that these expectations will prove to have been correct. All such forward-looking statements are subject to risks and uncertainties, many of which are outside of our control, and could cause future events or results to be materially different from those stated or implied in this document. It is not possible to predict or identify all such risks. These risks include, but are not limited to: our ability to design and execute our business strategy; changes in consumer preferences and buying patterns; our ability to compete in our markets; the occurrence of unfavorable publicity; risks associated with long-term non-cancellable leases for our centers; our ability to retain key managers; risks associated with our substantial indebtedness and limitations on future sources of liquidity; our ability to carry out our expansion plans; our ability to successfully defend litigation brought against us; our ability to adequately obtain, maintain, protect and enforce our intellectual property and proprietary rights and claims of intellectual property and proprietary right infringement, misappropriation or other violation by competitors and third parties; failure to hire and retain qualified employees and personnel; the cost and availability of commodities and other products we need to operate our business; cybersecurity breaches, cyber-attacks and other interruptions to our and our third-party service providers’ technological and physical infrastructures; catastrophic events, including war, terrorism and other conflicts; public health emergencies and pandemics, such as the COVID-19 pandemic, or natural catastrophes and accidents; changes in the regulatory atmosphere and related private sector initiatives; fluctuations in our operating results; economic conditions, including the impact of increasing interest rates, inflation and recession; and other factors described under the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) by the Company on September 11, 2023, as well as other filings that the Company will make, or has made, with the SEC, such as Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this press release and in other filings. We expressly disclaim any obligation to publicly update or review any forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by applicable law.

For Media:

IRSupport@BowleroCorp.com

Source: Bowlero Corp

Release – NN, Inc. Announces Chris Bohnert as Chief Financial Officer

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on NNBR

30 Year Veteran Brings Decades of Global Manufacturing Experience and Expertise Leading Through Transformative Periods

CHARLOTTE, N.C., June 24, 2024 (GLOBE NEWSWIRE) — NN, Inc. (NASDAQ: NNBR), a global diversified industrial company that engineers and manufactures high-precision components and assemblies, today announced the appointment of Chris Bohnert as Chief Financial Officer, effective June 25, 2024. Bohnert brings over 30 years of global manufacturing leadership experience as an accomplished CFO with significant experience in successful business transitions and deep accounting expertise. Bohnert will report directly to NN’s Chief Executive Officer, Harold Bevis. Bohnert succeeds Mike Felcher, who is departing the company to pursue other opportunities. Felcher will stay on as a consultant to assist with the transition.

“Chris’s deep experience in manufacturing company turnarounds, IT, investor relations, and banking will make an immediate impact,” said Harold Bevis, President and CEO of NN, Inc. “Chris and I have worked together before and now is the right time to make this change. We are going to both pick up the pace and broaden our objectives. Chris is operationally savvy, proactive and has a track record of delivering results. This will be an accelerator for NN’s transformation.”

Bohnert has extensive experience in senior financial leadership roles at public and private equity companies, having most recently served as advisor to the CEO at Commercial Vehicle Group (CVG), and prior to that, EVP and CFO. In his role at CVG, he led a global team of 200 people across finance, accounting and IT, and helped lead a significant transformation of the company. Bohnert has also held senior financial leadership roles at Calumet, Titan International, Silgan Plastics and Fleischmann’s Yeast.

“I am deeply honored to join NN and help the team achieve its transformation goals,” said Bohnert. “This role represents a unique opportunity to blend my financial skills in banking and investor relations with my global operations, IT and manufacturing expertise. The company has significantly enhanced its operations, cash flow and profitability profile in the last year, and I believe we have a significant opportunity to step up the pace and magnitude of our efforts. This will help us drive value for all of our stakeholders.”

As a material inducement to Mr. Bohnert to enter into employment with the Company, the Board of Directors approved the grant of the following inducement equity awards (collectively, the Inducement Awards), granted outside the Company’s stockholder-approved equity incentive plan, with a grant date of June 25, 2024: (i) 189,000 time-vesting restricted stock units (RSUs), which will vest ratably in one-fifth increments on each of the first five anniversaries of the grant date; and (ii) 287,000 performance-vesting RSUs (PSUs), 41,000 of which will be earned upon the Company’s average stock price meeting or exceeding a price of $5.00 per share over a period of 20 consecutive days, with an additional 41,000 PSUs being earned for each dollar increase to the average stock price thereafter, with a cap of $11.00, subject further to a five-year vesting period.

As a result of the Inducement Grants, the Company does not anticipate granting any further equity, as part of his annual compensation or otherwise, to Mr. Bohnert before 2029, and as such, the Inducement Awards effectively serve as his 2024, 2025, 2026, 2027, and 2028 annual long-term incentive awards. The Company designed the Inducement Awards, in part, to (i) align, in case of the PSUs, the interests of Mr. Bohnert and the Company’s shareholders, as the equity is only earned as shareholders experience value creation, and (ii) prioritize retention of Mr. Bohnert through the entire five-year performance and vesting period.

About NN, Inc.

NN, Inc., a global diversified industrial company, combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets on a global basis. Headquartered in Charlotte, North Carolina, NN has facilities in North America, Europe, South America, and Asia. For more information about the company and its products, please visit www.nninc.com.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include this statement for purposes of complying with these safe harbor provisions. Except for specific historical information, many of the matters discussed in this press release may express or imply projections of revenues or expenditures, statements of plans and objectives or future operations or statements of future economic performance. These statements may discuss goals, intentions, and expectations as to future trends, plans, events, results of operations or financial condition, or state other information relating to NN, Inc. based on current beliefs of management as well as assumptions made by, and information currently available to, management. Forward-looking statements generally will be accompanied by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “intend,” “may,” “possible,” “potential,” “predict,” “project” or other similar words, phrases or expressions. Forward-looking statements involve a number of risks and uncertainties that are outside of management’s control and that may cause actual results to be materially different from such forward-looking statements. Such factors include, among others, general economic conditions and economic conditions in the industrial sector; the impacts of pandemics, epidemics, disease outbreaks and other public health crises on our financial condition, business operations and liquidity; competitive influences; risks that current customers will commence or increase captive production; risks of capacity underutilization; quality issues; material changes in the costs and availability of raw materials; economic, social, political and geopolitical instability, military conflict, currency fluctuation, and other risks of doing business outside of the United States; inflationary pressures and changes in the cost or availability of materials, supply chain shortages and disruptions, the availability of labor and labor disruptions along the supply chain; our dependence on certain major customers, some of whom are not parties to long-term agreements (and/or are terminable on short notice); the impact of acquisitions and divestitures, as well as expansion of end markets and product offerings; our ability to hire or retain key personnel; the level of our indebtedness; the restrictions contained in our debt agreements; our ability to obtain financing at favorable rates, if at all, and to refinance existing debt as it matures; new laws and governmental regulations; the impact of climate change on our operations; and cyber liability or potential liability for breaches of our or our service providers’ information technology systems or business operations disruptions. The foregoing factors should not be construed as exhaustive and should be read in conjunction with the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the Company’s filings made with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. New risks and uncertainties may emerge from time to time, and it is not possible for the Company to predict their occurrence or how they will affect the Company. The Company qualifies all forward-looking statements by these cautionary statements.

Contact:
Joe Caminiti or Stephen Poe, Investors
Tim Peters or Emma Brandeis, Media
NNBR@alpha-ir.com
312-445-2870

Source: NN, Inc.

Release – Ahead of Artemis 2, V2X Awarded $265 Million Contract to Support NASA Astronauts Going to Space

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on VVX

MCLEAN, Va., June 24, 2024 /PRNewswire/ — V2X, Inc. (NYSE: VVX) has been awarded a $265 million contract to maintain safe operations at NASA’s Johnson Space Center in Houston, specifically at the Sonny Carter Training Facility, where astronauts receive crucial training to prepare for human spaceflight missions. V2X will deliver technical support to ensure the reliability of the integrated hardware and software systems utilized at the Neutral Buoyancy Laboratory (NBL). The contract’s period of performance extends until 2033, including option periods.

The NBL will serve as a training ground for NASA’s upcoming Artemis 2 mission, scheduled to launch in September 2025. The Artemis 2 missions will include the historic journey of the first woman and person of color to visit the moon, marking humanity’s return to the lunar surface after more than fifty years. The crew will land near the moon’s south pole, a region characterized by immense craters, extreme temperatures, and areas of permanent darkness, thus requiring extensive and meticulous preparation.

“We are honored to continue our partnership with NASA and support their mission to explore the frontiers of space,” said Jeremy Wensinger, President and Chief Executive Officer of V2X. “The Neutral Buoyancy Laboratory is an unparalleled facility, and we are committed to ensuring its readiness for the next generation of space exploration, including the groundbreaking Artemis 2 mission.”

At the NBL astronauts rehearse recovery missions, which are vital for the final stage of spaceflight when the crew’s capsule returns to Earth and splashes down into the ocean. Additionally, the laboratory houses a replica of the International Space Station, where astronauts practice working in microgravity, simulating the reduced gravity experienced in space. Recently, NASA and V2X have upgraded the NBL by converting a section into a realistic model of the moon’s surface.

As a critical asset for NASA, the NBL operates continuously to support the dynamic demands of human spaceflight.  For over 30 years, it has been instrumental in training astronauts for space exploration, providing a realistic environment for practicing spacewalks and recovery missions.

About V2X

V2X delivers a comprehensive suite of integrated solutions across defense and commercial training, operations and logistics, aerospace, and technology markets to national security, defense, civilian and international clients. Our global team of approximately 16,000 employees brings innovation to every point in the mission lifecycle, from preparation to operations, to sustainment, as it tackles the most complex challenges with agility, grit, and dedication.

Media Contact
Angelica Spanos Deoudes 
Director, Corporate Communications  
Angelica.Deoudes@goV2X.com 
571-338-5195

Investor Contact
Mike Smith, CFA 
Vice President, Treasury, Corporate Development and Investor Relations 
IR@goV2X.com 
719-637-5773

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ahead-of-artemis-2-v2x-awarded-265-million-contract-to-support-nasa-astronauts-going-to-space-302179705.html

SOURCE V2X, Inc.

Vince Holding Corp. (VNCE ) – Fashioning A Growth Company

Posted on by cpereira@noblefcm.com


Monday, June 24, 2024

500 5th Avenue 20th Floor New York, NY 10110 United States Sector(s): Consumer Cyclical Industry: Apparel Manufacturing Full Time Employees: 599 Key Executives Name Title Pay Exercised Year Born Mr. Jonathan CEO & Director 825.62k N/A 1958 Ms. Marie Fogel Senior VP and Chief Merchandising & Manufacturing Officer 633.19k N/A 1961 Mr. John Chief Financial Officer

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

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

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

Initiating coverage. The company appears to be well on its way toward favorable revenue growth and improving margins, along with a healthier balance sheet. We believe that investors have not yet caught up to the story of the company’s transformation. We are initiating coverage with an Outperform rating and a $3 price target. 

Attractive position in the fashion industry. The company offers luxury, high quality men’s and women’s apparel that is in a fashion growth category of sophisticated, unstructured, casual wear. We believe that there is a significant price umbrella with other designer brands that should allow the company to reduce discounting, raise prices and increase its market share in the premium brand space. 


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

The GEO Group (GEO) – A Contract Termination

Posted on by cpereira@noblefcm.com


Monday, June 24, 2024

The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 103 facilities totaling approximately 83,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.

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.

Lawton Termination. GEO announced the discontinuation of its contract with the Oklahoma Department of Corrections for the company-owned, 2,600-bed Lawton Correctional and Rehabilitation Facility, which is set to expire on June 30, 2024, unless extended for an additional three months under terms proposed by GEO.

Why? In our discussions with management, the facility is not performing up to GEO expectations due to inadequate current funding levels provided by the State and difficulty in attracting sufficient staffing, a problem across the State DOC. GEO noted a closure would not have a material impact on financial guidance for 2024. It is our view that by providing notice to the State, GEO is hopeful a realistic funding solution can be found with the State, either as currently operated or, potentially, with GEO entering into a lease of the facility with the State operating the facility.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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

Graham Corp. (GHM) – Mission Critical Supplier With Solid Growth Prospects

Posted on by cpereira@noblefcm.com


Monday, June 24, 2024

Graham Corporation designs, manufactures and sells critical equipment for the energy, defense and chemical/petrochemical industries. The Company designs and manufactures custom-engineered ejectors, vacuum pumping systems, surface condensers and vacuum systems. It is a nuclear code accredited fabrication and specialty machining company. It supplies components used inside reactor vessels and outside containment vessels of nuclear power facilities. Its equipment is found in applications, such as metal refining, pulp and paper processing, water heating, refrigeration, desalination, food processing, pharmaceutical, heating, ventilating and air conditioning. For the defense industry, its equipment is used in nuclear propulsion power systems for the United States Navy. The Company’s products are used in a range of industrial process applications in energy markets, including petroleum refining, defense, chemical and petrochemical processing, power generation/alternative energy and other.

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.

Initiating Research Coverage. We are initiating research coverage of Graham Corporation with an Outperform rating and a $35 price target. GHM is a provider of  mission critical fluid, power, heat transfer, and vacuum technologies for the defense, space, energy, and process industries. The Company’s expanding business with the defense industry, specifically the U.S. Navy, has reduced cyclicality, while enabling the Company to target other, high growth end markets.

Improving Margins. With the completion of first order units for the U.S. Navy and the implementation of a strategic plan, Graham is well positioned to drive increased profitability. In fiscal 2024, gross margin expanded by 570 bp to 21.9%, which is expected to grow to 22%-23% in fiscal 2025.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Lassonde Industries Expands Specialty Food Presence with $235 Million Acquisition of Summer Garden

Posted on by slightbourne@noblecapitalmarkets.com

In a strategic move to bolster its position in the North American specialty food market, Lassonde Industries Inc. has announced an agreement to acquire Summer Garden Food Manufacturing for $235 million USD. This acquisition marks a significant step in Lassonde’s ambition to become a more diversified food and beverage powerhouse in North America.

Summer Garden, operated by The Zidian Group and based in Boardman, Ohio, is a renowned manufacturer and distributor of premium sauces and condiments. With a workforce of approximately 200 employees, the company has built a strong reputation for its high-quality products, including pasta sauces, BBQ sauces, dipping sauces, and dressings. The acquisition brings popular brands such as Gia Russa, Little Italy in the Bronx, and G Hughes – a leader in the sugar-free BBQ sauce segment – under the Lassonde umbrella.

The deal structure includes an initial payment of $235 million USD at closing, with the potential for additional payments of up to $45 million USD over the next three years, contingent on meeting certain financial targets and conditions. This approach aligns the interests of both parties and incentivizes continued growth and performance.

Financially, the acquisition appears promising for Lassonde. Summer Garden reported impressive figures for the 12-month period ending May 2024, with sales of $148 million USD and adjusted EBITDA of approximately $27.9 million USD. Lassonde expects the transaction to be accretive to margins and earnings, even before considering potential synergies. The company also anticipates that the acquisition’s internal rate of return will exceed its weighted-average cost of capital, indicating a sound financial investment.

Moreover, the transaction structure allows Lassonde to benefit from tax deductibility, generating an estimated $30 million USD in net present value. Post-acquisition, Lassonde projects its pro forma net debt to adjusted EBITDA ratio to remain under 2.20 to 1, providing ample room for future strategic initiatives.

Nathalie Lassonde, CEO and Vice-Chair of Lassonde’s board of directors, emphasized the strategic importance of the acquisition, stating that it supports the company’s ambition to diversify and grow its specialty food activities. She also highlighted the cultural alignment between the two family-owned businesses, noting their shared entrepreneurial spirit and commitment to stakeholders.

For Summer Garden, this acquisition ensures the continuation of its legacy under the stewardship of a larger, like-minded organization. Thomas Zidian, President and CEO of Summer Garden, expressed confidence that the partnership would benefit customers through enhanced products and offer employees new opportunities for development and advancement.

The acquisition is expected to close within 30 to 45 days, subject to regulatory clearance and other closing conditions. Lassonde plans to finance the transaction through its available credit facilities, demonstrating its strong financial position and commitment to growth.

This move by Lassonde Industries represents a significant consolidation in the specialty food sector and aligns with broader trends of larger food and beverage companies expanding their portfolios through strategic acquisitions. By integrating Summer Garden’s products, brands, and manufacturing capabilities, Lassonde is poised to enhance its market presence, diversify its product offerings, and potentially realize operational synergies.

As the food industry continues to evolve, with consumers increasingly seeking premium, specialized products, this acquisition positions Lassonde to capitalize on these trends and reinforce its status as a leading player in the North American food and beverage landscape.

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