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/C O R R E C T I O N — NeuroRx/

PR Newswire

In the news release, NeuroRx Announces ZYESAMI™ (aviptadil, RLF-100) Met the Primary Endpoint of Its Phase 2b/3 Clinical Trial and Also Demonstrated a Meaningful Benefit in Survival from Critical COVID-19, issued 29-Mar-2021 by NeuroRx over PR Newswire, we are advised by the company that more media contact information is needed to be included with the release. The complete, corrected release follows:

NeuroRx Announces ZYESAMI™ (aviptadil, RLF-100) Met the Primary Endpoint of Its Phase 2b/3 Clinical Trial and Also Demonstrated a Meaningful Benefit in Survival from Critical COVID-19

RADNOR, Pa., March 29, 2021 /PRNewswire/ — NeuroRx, Inc. today reports 60-day results of the Phase 2b/3 trial of intravenously-administered ZYESAMI™ (aviptadil acetate) for the treatment of respiratory failure in critically-ill patients with COVID-19, which is being developed in collaboration with Relief Therapeutics Holding AG (SIX:RLF, OTCQB:RLFTF). Across all patients and sites, ZYESAMI™ met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site.

In addition to the robust overall significance across all 196 treated patients at all 10 clinical sites, the prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals. In this group, ZYESAMI™ patients had a 71% chance of successful recovery by day 28 vs. 48% in the placebo group (P = .017) and a 75% rate of successful recovery by day 60 vs. 55% in the placebo group (P = .036).  Eighty-four percent (84%) of HFNC patients treated at tertiary medical centers with ZYESAMI™ survived to day 60 compared with 60% of those treated with placebo (P = .007).

To the company’s knowledge, ZYESAMI™ is the first COVID-19 therapeutic to demonstrate advantages in both survival and recovery from critical COVID-19 in a randomized, double-blind multicenter trial. On the basis of these findings, NeuroRx plans to apply immediately to the United States Food and Drug Administration (“FDA”) for Emergency Use Authorization (EUA) and to subsequently submit a New Drug Application (NDA).

Recovery from respiratory failure (without relapse) with discharge from acute care and survival through the observation period was the prespecified primary endpoint specified by FDA for the study, originally intended to be assessed at 28 days and then extended to 60 days based on recently-published FDA guidance. The above analysis includes all 196 participants who were randomized and treated in the placebo-controlled, double-blind clinical trial (www.clinicaltrials.gov NCT04311697) conducted at 10 US hospitals. Treatment with ZYESAMI™ or placebo was in addition to standard of care treatment that included steroids, convalescent plasma, antiviral therapy, anticoagulants, and various anti-cytokine drugs.

NeuroRx has announced the commencement of a clinical trial of inhaled ZYESAMI™ for the treatment of patients with moderate and severe COVID-19 with the aim of preventing progression to respiratory failure. NeuroRx has also announced the inclusion of inhaled ZYESAMI™ in the I-SPY clinical trial platform for patients with COVID-19 respiratory failure. The company has signed a clinical trial participation agreement with the National Institutes of Health.

The study’s coordinating committee, including Professors Dushyantha Jayaweera, MD, FACP (University of Miami), Richard Lee, MD, (UC Irvine), and J. Georges Youssef, MD (Houston Methodist Hospital) commented, “The 60-day observation framework implemented last month by FDA for critically ill patients with COVID-19 is more consistent with the clinical course of this lethal disease than the 28-day time frame originally adapted from other conditions that cause respiratory distress. The association of baseline oxygenation status (high flow nasal oxygen vs. ventilation) is not surprising in that patients who require mechanical or noninvasive ventilation in order to maintain blood oxygen are likely to have substantially more damage to the lining of their lungs compared to patients whose blood oxygen level can be maintained with high-flow oxygen delivered to the nose. The finding that patients fared substantially better in tertiary care centers as compared to regional hospitals may be influenced by the intensity of the public health crisis at the regional hospitals that participated in the study, all of which were operating at 200% or higher overcapacity in their intensive care units with implementation of temporary ICU beds and shortages of critical care staff.”

Prof. Jonathan Javitt, MD, MPH, Chairman and CEO of NeuroRx, said, “ZYESAMI has now demonstrated itself in a phase 2/3 trial, conducted under FDA Fast Track Designation, not only to shorten hospitalization (as was previously reported) but also to save lives and increase the likelihood of patients returning safely home to their families. In exactly 12 months, a lifesaving drug has advanced from concept to clinical success in partnership with Relief Therapeutics in the midst of a public health emergency that has claimed the lives of millions. Today’s findings confirm the often dramatic clinical success that has been seen in numerous patients treated in the US and abroad under emergency use protocols. We look forward to working with the National Institutes of Health, the Department of Defense, the FDA, and regulators around the world to bring this treatment to patients as quickly as possible.”

An investor conference call will be held today, March 29th at 8:30am EDT. Participants can dial (+1) 866-373-3402 or join via webcast at https://bit.ly/3sqPyDS. Those wishing to ask questions should submit those questions to [email protected].

NeuroRx, Inc. has signed an agreement to merge with Big Rock Acquisition Corp. Details may be viewed at http://irdirect.net/filings/viewer/index/1719406/000119312521019278/

About VIP in COVID-19
Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970. Although first identified in the lung, it was purified from the intestinal tract. VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, VIP binds specifically to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung. VIP stimulates ATII cells to make the surfactant that must coat the lining of the lung in order for the lung to exchange oxygen with the blood.  Loss of surfactant causes respiratory failure and alveolar collapse, which is a hallmark of COVID-19.

COVID-19-related respiratory failure is caused by selective infection of the ATII cell by the SARS-CoV-2 virus. The ATII cells are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. Coronavirus infection of the ATII cell shuts down surfactant production, triggers the formation of inflammatory cytokines, and causes cell death (cytopathy). VIP is shown to upregulate surfactant production, block Coronavirus replication in the ATII cell, block cytokine synthesis, and prevent viral-induced cell death (cytopathy). To our knowledge, other than ZYESAMI™, no currently proposed treatments for COVID-19 specifically target this mechanism of action.

About NeuroRx, Inc.
NeuroRx draws upon more than 100 years of collective drug development experience from senior executives of AstraZeneca, Eli Lilly, Novartis, Pfizer, and PPD. In addition to its work on Aviptadil, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression and is currently in Phase 3 trials. Its executive team is led by Prof. Jonathan C. Javitt, MD, MPH, who has served as a health advisor to four Presidential administrations and worked on paradigm-changing drug development projects for Merck, Allergan, Pharmacia, Pfizer, Novartis, and Mannkind, together with Robert Besthof, MIM, who served as the Global Vice President (Commercial) for Pfizer’s Neuroscience and Pain Division. NeuroRx recently announced a plan to complete a business combination with Big Rock Partners Acquisition Corp (NASDAQ:BRPA) (“BRPA”), and intends to apply for listing on the NASDAQ under the proposed symbol “NRXP”.

About Relief Therapeutics Holding AG
Relief focuses primarily on clinical-stage programs based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications. Its lead drug candidate RLF-100™ (aviptadil) is being investigated in two placebo-controlled U.S. phase 2b/3 clinical trials in respiratory failure due to COVID-19. Relief also holds a patent issued in the United States and various other countries covering potential formulations of RLF-100™. Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. www.relieftherapeutics.com.


Cautionary Note Regarding Forward Looking Statements

Statements contained in this press release that are not historical facts may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally relate to future events or NeuroRx’s future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern NeuroRx’s expectations, strategy, plans or intentions. Such forward-looking statements may relate to, among other things, the outcome of any discussions or applications for the future use of ZYESAMI, the approvals, timing, and ability to complete the proposed business combination with BRPA, and the combined company’s ability to continue listing on Nasdaq after closing the proposed business combination. Such forward-looking statements do not constitute guarantees of future performance and are subject to a variety of risks and uncertainties. NeuroRx does not undertake any obligation to update forward-looking statements as a result of new information, future events or developments or otherwise.


Additional Information and Where to Find It

This press release relates to a proposed business combination and related transactions (the “Transactions”) between NeuroRx and BRPA. This press release does not constitute an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. BRPA has filed a registration statement on Form S-4 (“Registration Statement”), which includes a preliminary proxy statement for the solicitation of the approval of BRPA’s stockholders, a preliminary prospectus for the offer and sale of BRPA’s securities in the Transactions and a preliminary consent solicitation statement of NeuroRx, and other relevant documents with the SEC. The proxy statement/prospectus/consent solicitation statement will be mailed to stockholders of NeuroRx and BRPA as of a record date to be established for voting on the proposed business combination. INVESTORS AND SECURITY HOLDERS OF NEURORX AND BRPA ARE URGED TO READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS/CONSENT SOLICITATION STATEMENT AND OTHER RELEVANT DOCUMENTS THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTIONS. Investors and security holders will be able to obtain free copies of the registration statement, proxy statement, prospectus and other documents containing important information about NeuroRx and BRPA once such documents are filed with the SEC, through the website maintained by the SEC at http://www.sec.gov. In addition, copies of the documents filed with the SEC by BRPA can be obtained free of charge on BRPA’s website at www.bigrockpartners.com or by directing a written request to BRPA at 2645 N. Federal Highway, Suite 230 Delray Beach, FL 33483.


Participants in the Solicitation

NeuroRx, BRPA and their respective directors and executive officers, under SEC rules, may be deemed to be participants in the solicitation of proxies of BRPA’s stockholders in connection with the proposed Transactions. Investors and securityholders may obtain more detailed information regarding the names and interests in the proposed Transactions of NeuroRx’s and BRPA’s respective directors and officers in BRPA’s filings with the SEC, including the proxy statement/consent solicitation statement/prospectus statement. You may obtain a free copy of these documents as described in the preceding paragraph.

CORPORATE CONTACT

Jonathan C. Javitt, M.D., MPH
Chairman and Chief Executive Officer
[email protected]  

INVESTOR RELATIONS

Ryan Sheffield

[email protected]  
(484) 254-6134, ext. 723

MEDIA RELATIONS

Greg Parasmo

[email protected]  
(484) 254-6134, ext. 724

 

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SOURCE NeuroRx

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Astanza Laser Designated as a Great Place to Work-Certified™ Company in 2021

Dallas, Texas, March 29, 2021 (GLOBE NEWSWIRE) — Astanza Laser, an award-winning industry-leading aesthetic laser company, has been designated as one of the top places to work in the United States and is now a 2020 Great Place to Work-Certified™ company. Great Place to Work is the global authority on workplace culture, employee experience, and the leadership behaviors proven to deliver market-leading revenue and increased innovation. 

“We are thrilled to be Great Place to Work-Certified™,” says David Murrell, President of Astanza. “We prioritize our team members’ happiness every day to ensure our Astanza family feels respected and valued. It means a lot that our employees have reported a consistently positive experience with their coworkers, their leaders, and their jobs. We often say that Astanza does more than just sell lasers–we’re in the business of changing lives, and that includes everyone from our clients, to their patients, and our team members. This Great Place to Work Certification exemplifies the strong company culture that Astanza has built and proves that employee satisfaction is the driving force for business growth and success and making a true difference in our clients’ lives.”

Certification is a significant achievement that recognizes strong corporate culture, employee empowerment, approachable management, and a positive work environment. Using validated employee feedback gathered with Great Place to Work’s rigorous, data-driven For All methodology, a minimum of 7 out of 10 employees must report a consistently positive experience at Astanza to gain Certification. Furthermore, an organization must meet a positive rate of 46% or higher and a Trust Index™ score of 65% or greater. Overall, 100% of Astanza’s employees participated in the survey which resulted in a 96% Trust Index score, landing Astanza in the top 5% of certified companies nationwide.

“We congratulate Astanza on their Certification,” said Sarah Lewis-Kulin, Vice President of Best Workplace List Research at Great Place to Work. “Organizations that earn their employees’ trust create great workplace cultures that deliver outstanding business results.”

About Astanza Laser

Astanza is the leader in lasers for tattoo removal, hair removal, and additional aesthetic procedures. In addition to delivering cutting-edge medical laser devices such as the Duality, Trinity, MeDioStar, and DermaBlate systems, Astanza offers its customers a complete range of training, marketing, and business consulting services to achieve success in this growing field. Astanza is an award-winning company that has received several accolades from leading industry organizations, including MyFaceMyBody and Aesthetic Everything. They are also certified as a “Great Place to Work”.

Astanza offers a dynamic work environment where initiative, creativity, and education are valued. Interested in joining the Astanza team? Visit our career page to see our available positions.

Astanza Laser is headquartered in Dallas, TX, with customers throughout North America and Europe. For product, investor, or press information, call (800) 364-9010, or visit https://astanzalaser.com/. Connect with Astanza on LinkedIn, Facebook, Instagram, Twitter, and YouTube.

About Great Place to Work®

Great Place to Work® is the global authority on workplace culture. Since 1992, they have surveyed more than 100 million employees around the world and used those deep insights to define what makes a great workplace: trust. Great Place to Work helps organizations quantify their culture and produce better business results by creating a high-trust work experience for all employees. Emprising®, their culture management platform, empowers leaders with the surveys, real-time reporting, and insights they need to make data-driven people decisions. Their unparalleled benchmark data is used to recognize Great Place to Work-Certified™ companies and the Best Workplaces™ in the US and more than 60 countries, including the 100 Best Companies to Work For® and World’s Best list published annually in Fortune. Everything they do is driven by the mission to build a better world by helping every organization become a Great Place to Work For All™.

To learn more, visit greatplacetowork.com, listen to the podcast Better by Great Place to Work, and read “A Great Place to Work for All.” Join the community on LinkedIn, Twitter, and Instagram.



Astanza Laser
Astanza Laser
(800) 364-9010
[email protected]

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Golden Star Announces Amendment of Agreement for the Sale of Bogoso-Prestea

PR Newswire

TORONTO, March 29, 2021 /PRNewswire/ – Golden Star Resources Ltd. (NYSE American: GSS) (TSX: GSC) (GSE: GSR) (“Golden Star” or the “Company”) announces that, on March 28, 2021, the Company and its wholly owned subsidiary, Caystar Holdings (“Caystar”), entered into an agreement (the “Amending Agreement”) with Future Global Resources Limited (“FGR”) and its major shareholder, Blue International Holdings Limited (“BIH”), to amend the share purchase agreement dated July 26, 2020 relating to the sale of Golden Star’s 90% interest in the Bogoso-Prestea Gold Mine (“Bogoso-Prestea”) in Ghana to FGR, as supplemented by a letter agreement dated September 30, 2020 (the “Share Purchase Agreement”). All references herein to “$” are to United States dollars.

The staged payments that form the deferred consideration, as outlined in the Share Purchase Agreement, have now been reprofiled to allow time for FGR to complete the environmental bonding process for Bogoso-Prestea and to bring forward the second deferred payment due in 2021 such that both staged payments will be made together on 31 May, 2021, some two months earlier than previously anticipated. The deferred consideration payments will now fall due as follows:

  • The $5 million payment that was due on March 30, 2021 will now be payable by no later than May 31, 2021;
  • The $10 million payment that was due to be paid on July 31, 2021 will be brought forward for payment by no later than May 31, 2021; and
  • An amount of approximately $4.6m (comprised of the working capital balancing payment of approximately $4.3 million and fees of approximately $0.3 million for services provided by Caystar to FGR pursuant to a transition agreement dated September 30, 2020) will continue to fall due by no later than July 31, 2021.

Pursuant to the terms of the Amendment Agreement, FGR will put in place a reclamation bond in respect of its environmental rehabilitation obligations for Bogoso-Prestea, and pay to the Environmental Protection Agency of Ghana (the “EPA”) the amount agreed with the EPA by no later than March 30, 2021 or such later date (or dates, as applicable) as may be agreed between the EPA and FGR.

Company Profile:

Golden Star is an established gold mining company that owns and operates the Wassa underground mine in the Western Region of Ghana, West Africa.  Listed on the NYSE American, the Toronto Stock Exchange and the Ghanaian Stock Exchange, Golden Star is focused on delivering strong margins and free cash flow from the Wassa mine.  As the winner of the Prospectors & Developers Association of Canada 2018 Environmental and Social Responsibility Award, Golden Star remains committed to leaving a positive and sustainable legacy in its areas of operation.

Statements Regarding Forward-Looking Information

Some statements contained in this news release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and “forward looking information” within the meaning of Canadian securities laws and include but are not limited to, statements and information regarding: the date at which FGR puts in place a new reclamation bond with the EPA; and the receipt by Golden Star of the deferred consideration and/or contingent payment, and the potential amount and timing thereof.  Generally, forward-looking information and statements can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “believes” or variations of such words and phrases (including negative or grammatical variations) or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved” or the negative connotation thereof. Investors are cautioned that forward-looking statements and information are inherently uncertain and involve risks, assumptions and uncertainties that could cause facts to differ materially. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which Golden Star will operate in the future, including the price of gold, anticipated costs and ability to achieve goals. Forward-looking information and statements are subject to known and unknown risks, uncertainties and other important factors that may cause the actual results, performance or achievements of Golden Star to be materially different from those expressed or implied by such forward-looking information and statements, including but not limited to: gold price volatility; discrepancies between actual and estimated production; mineral reserves and resources and metallurgical recoveries; mining operational and development risks; liquidity risks; suppliers suspending or denying delivery of products or services; regulatory restrictions (including environmental regulatory restrictions and liability); actions by governmental authorities; the speculative nature of gold exploration; ore type; the global economic climate; share price volatility; foreign exchange rate fluctuations; risks related to streaming agreements and joint venture operations; the availability of capital on reasonable terms or at all; risks related to international operations, including economic and political instability in foreign jurisdictions in which Golden Star operates; risks related to current global financial conditions including financial and other risks resulting from the impact of the COVID-19 global pandemic; actual results of current exploration activities; environmental risks; future prices of gold; possible variations in mineral reserves and mineral resources, grade or recovery rates; mine development and operating risks; an inability to obtain power for operations on favorable terms or at all; mining plant or equipment breakdowns or failures; an inability to obtain products or services for operations or mine development from vendors and suppliers on reasonable terms, including pricing, or at all; public health pandemics such as COVID-19, including risks associated with reliance on suppliers, the cost, scheduling and timing of gold shipments, uncertainties relating to its ultimate spread, severity and duration, and related adverse effects on the global economy and financial markets; accidents, labor disputes and other risks of the mining industry; delays in obtaining governmental approvals or financing or in the completion of development or construction activities; litigation risks; the quantum and timing of receipt of the proceeds from the sale by the Company of its interest in Bogoso-Prestea; and risks related to indebtedness and the service of such indebtedness. Although Golden Star has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information and statements, there may be other factors that cause results not to be as anticipated, estimated or intended.  There can be no assurance that future developments affecting the Company will be those anticipated by management.  Please refer to the discussion of these and other factors in Management’s Discussion and Analysis of financial conditions and results of operations for the year ended December 31, 2019 and in our annual information form for the year ended December 31, 2019 as filed on SEDAR at www.sedar.com.  The forecasts contained in this press release constitute management’s current estimates, as of the date of this press release, with respect to the matters covered thereby.  We expect that these estimates will change as new information is received.  While we may elect to update these estimates at any time, we do not undertake any estimate at any particular time or in response to any particular event.

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SOURCE Golden Star Resources Ltd.

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Devon Energy Issues Updated Guidance Including Impact from Winter Storm and Asset Sale

KEY MESSAGES

  • Devon provided guidance for the first quarter and full-year 2021, adjusted for weather and an asset sale
  • Severe winter weather is estimated to reduce first-quarter production by 8 percent
  • Guidance excludes WPX results prior to the acquisition close date of Jan. 7, 2021
  • Sale of Wind River asset in Wyoming is expected to reduce 2021 oil production by 2,000 barrels per day

OKLAHOMA CITY, March 29, 2021 (GLOBE NEWSWIRE) — Devon Energy Corp. (NYSE: DVN) today provided guidance for the first quarter and full-year 2021 that incorporates the operational impact from recent winter weather and a minor asset sale. The company has restored its production to pre-storm levels and expects the weather-related downtime to be confined to the first quarter.

First-quarter production is estimated to be reduced by 8 percent due to the impact of severe winter weather. Adjusting for this downtime, Devon expects oil production in the first quarter of 261,000 to 265,000 barrels per day and total production of 485,000 to 499,000 oil-equivalent barrels per day. The company’s guidance also excludes WPX results prior to the acquisition close date of Jan. 7, 2021, limiting production by an incremental 3 percent for the first quarter.

“I would like to personally thank the team for their hard work and dedication preparing for and safely responding to the unprecedented severe weather conditions,” said Rick Muncrief, president and CEO. “With our operations fully restored to pre-storm levels, we are well positioned to execute on our disciplined capital plan, accelerate free cash flow generation and return increasing amounts of cash to shareholders.”

Per-unit expenses are expected to increase by approximately 5 percent in the first quarter as a result of the weather impact across Devon’s operations.

The company’s full-year 2021 guidance was also adjusted for the sale of the company’s Wind River asset in Wyoming which closed on March 3, 2021. This divesture is expected to reduce oil production by approximately 2,000 barrels per day for the full-year 2021.

Additional details of Devon’s forward-looking guidance for the first quarter and full-year 2021 are available on the company’s website at www.devonenergy.com.

ABOUT DEVON ENERGY

Devon Energy is a leading oil and gas producer in the U.S. with a premier multi-basin portfolio headlined by a world-class acreage position in the Delaware Basin. Devon’s disciplined cash-return business model is designed to achieve strong returns, generate free cash flow and return capital to shareholders, while focusing on safe and sustainable operations. For more information, please visit www.devonenergy.com.

Investor Contacts Media Contact
Scott Coody, 405-552-4735 Lisa Adams, 405-228-1732
Chris Carr, 405-228-2496  

FORWARD LOOKING STATEMENTS

This press release contains “forward-looking statements” within the meaning of the federal securities laws. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Devon. These risks include, but are not limited to: the risk that we experience further production downtime, higher-than expected expenses (including from third-party claims) or other adverse impacts from Winter Strom Uri and its effects; and the other risks identified in Devon’s 2020 Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Investors are cautioned that any such statements are not guarantees of future performance and that actual results or developments may differ materially and adversely from those projected in the forward-looking statements. The forward-looking statements in this press release are made as of the date hereof, and Devon does not undertake, and expressly disclaim, any duty to update or revise our forward-looking statements based on new information, future events or otherwise.



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Adagene Announces Clinical Advancement for ADG116

-NEObody™ product candidate ADG116 has been well tolerated in ongoing Phase 1 clinical trial- 

-Promising pharmacodynamic biomarker signals demonstrate clinical proof of mechanism-

-Poised for global expansion-

SAN FRANCISCO and SUZHOU, China, March 29, 2021 (GLOBE NEWSWIRE) — Adagene Inc. (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced the interim dose-escalation data up to 0.3 mg/kg in its ongoing Phase 1 clinical trial in Australia evaluating the safety and tolerability of ADG116 in patients with advanced/metastatic solid tumors. ADG116 is a fully human, anti-CTLA-4 monoclonal antibody (mAb), designed to target a unique conserved epitope of CTLA-4 and utilizes Adagene’s proprietary NEObody platform technology. ADG116 is designed to balance safety and efficacy through a novel mechanism of action; ADG116 maintains its original physiological function via partial blocking of CTLA-4 ligand binding, and in conjunction, depletes Treg in the tumor microenvironment via strong antibody-dependent cellular cytotoxicity (ADCC).

Interim data for the ongoing Phase 1 clinical trial:

  • Safety: Analysis of all safety data generated to date demonstrates that ADG116 has been well-tolerated in more than 10 patients with no dose-limiting toxicities or unexpected safety signals. No drug related Grade 3 and Grade 4 toxicities have been observed.
  • Notable findings in pharmacodynamics: A dose-dependent change in CD8+ and CD4+ TEM / Treg ratios, important pharmacodynamic (PD) biomarkers indicating immune activation, was observed for patients dosed by ADG116. In particular, a patient, refractory to prior pembrolizumab therapy (> 25 cycles), demonstrated striking increases in T and NK cells, and CD8+ and CD4+ TEM / Treg ratios. The Grade 1 treatment-related pruritus of this patient is a clinical symptom consistent with immune-mediated action of ADG116 treatment.
  • Pharmacokinetics: The terminal half-life of ADG116 was within the normal range of IgG1 based antibodies.
  • Clinical proof of mechanism: The Phase 1 dose escalation data demonstrates the clinical proof of mechanism for ADG116 in targeting CTLA-4, consistent with preclinical observations for the potency of ADG116 starting from 0.03 to 0.3 mg/kg.

“We are encouraged by the positive PD marker signals and safety data,” said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. “It is particularly striking to observe immune activation biomarkers at 0.03 mg/kg, especially in the patient refractory to prior pembrolizumab therapies. We believe ADG116 has the potential to overcome the limitations of anti-CTLA-4 checkpoint inhibitors, extending the market potential beyond current anti-CTLA-4 inhibitors in both monotherapy and combination settings. Our highly differentiated anti-CTLA-4 therapeutics hold the potential to improve the clinical benefits by expanding clonal diversity, infiltrating into cold tumors, and treating patients resistant/refractory to current immuno-therapies.”

“We look forward to developing a comprehensive clinical program to evaluate each of our anti-CTLA-4 assets,” continued Dr. Luo. “We will leverage the modality-specific features demonstrated in the preclinical setting, that enable high-fidelity translation into the clinic by targeting unique, highly conserved epitope of CTLA-4 with broad species cross-reactivity. We remain committed to maximizing the full potential of our unique anti-CTLA-4 approach.”

The progression of the Phase 1 dose-escalation trial to the 5th dose, a 0.3mg/kg dose level, builds on encouraging signs of PD markers, normal PK data, strong early clinical data, extensive preclinical and safety tolerability data and a successful Safety Review Committee meeting. Multiple clinical sites are currently open in Australia. In this ongoing Phase 1 clinical trial of ADG116 in patients with advanced/metastatic solid tumors, no dose-limiting toxicity (DLT), treatment-related serious adverse events (SAEs), colitis or hepatitis have been observed. With favorable clinical data to date, Adagene looks forward to expanding the ongoing global Phase 1 trial, with the acceptance of revised study protocol by FDA to expand the trial in the U.S. Adagene has also obtained confirmation from China NMPA to proceed with revised protocol submission at higher starting dose than that in the original submission. Additional information about this clinical trial is available at ClinicalTrials.gov using the identifier: NCT04501276.

About ADG116

ADG116 is a fully human ligand-blocking anti-CTLA-4 mAb generated using NEObody technology. ADG116 is a differentiated anti-CTLA-4 approach, which leverages Adagene’s Dynamic Precision technology to target a conserved epitope with broad species cross-reactivity for translational fidelity and a unique CTLA-4 mechanism of action. In preclinical studies, ADG116 was observed to have softer CTLA-4 ligand blocking and stronger ADCC for depleting regulatory T-cells than ipilimumab. In a head-to-head in vivo efficacy study, ADG116 was observed to have at least a five-fold greater preclinical antitumor activity in comparison with ipilimumab. In preclinical studies, ADG116 was well tolerated in rats and cynomolgus monkeys in four-week repeat-dose GLP toxicology studies at doses up to 30 mg/kg, and demonstrated an encouraging antitumor response in multiple immune-competent mouse tumor models in a dose-dependent manner both as a single agent (showing initial response at 0.02mg/kg, and complete response at 0.1 mg/kg for tumor size of ~100mm3 in sensitive tumor models) and in combination with other therapies.

About Adagene

Adagene Inc. is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science.

For more information, please visit: https://investor.adagene.com.

Safe Harbor Statement

This press release contains forward-looking statements, including statements regarding data from the ADG116 preclinical studies and Phase 1 clinical trial, the potential implications of clinical data for patients, and Adagene’s advancement of, and anticipated clinical development, regulatory milestones, and commercialization of ADG116. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene’s drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the COVID-19 pandemic on Adagene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Investors Contact

Raymond Tam
Adagene
86-512-8777-3626
[email protected]

Bruce Mackle
LifeSci Advisors
646-889-1200
[email protected]

Media Contact

Annie Starr
6 Degrees
973-768-2170
[email protected]



Posted on

Advanced Emissions Solutions Will Increase Prices on all Activated Carbon Products and Front-End Coal Additives

GREENWOOD VILLAGE, Colo., March 29, 2021 (GLOBE NEWSWIRE) — Advanced Emissions Solutions, Inc. (NASDAQ: ADES) (the “Company” or “ADES”), the parent company of ADA-ES, Inc. and ADA Carbon Solutions, LLC (collectively, “ADA”), today announced a price increase, effective April 1, 2021 or as contract terms permit, on all activated carbon products and front-end coal additives. The increase will vary from 10% to 15% depending on the specific product, grade, and application.

Throughout the COVID-19 Global Pandemic, our team has remained focused on continuing to meet the needs of our customers reliably and consistently. We have adapted our processes, improved our safety protocols, and worked closely to maintain a robust supply chain. These price increases have become necessary due to increases in raw material, transportation, and operational costs to produce and deliver our products. This price recovery is a necessary step to ensure the business remains in a strong position to continue reliably serving our customers.

About Advanced Emissions Solutions, Inc.

Advanced Emissions Solutions, Inc. serves as the holding entity for a family of companies that provide emissions solutions to customers in the power generation and other industries.

ADA brings together ADA Carbon Solutions, LLC, a leading provider of powder activated carbon (“PAC”) and ADA-ES, Inc., the providers of ADA® M-Prove™ Technology.  We provide products and services to control mercury and other contaminants at coal-fired power generators and other industrial companies. Our broad suite of complementary products control contaminants and help our customers meet their compliance objectives consistently and reliably.

CarbPure Technologies LLC, (“CarbPure”), formed in 2015 provides high-quality PAC and granular activated carbon ideally suited for treatment of potable water and wastewater. Our affiliate company, ADA Carbon Solutions, LLC manufactures the products for CarbPure.

Tinuum Group, LLC (“Tinuum Group”) is a 42.5% owned joint venture by ADA that provides patented Refined Coal (“RC”) technologies to enhance combustion of and reduce emissions of NOx and mercury from coal-fired power plants.

Caution on Forward-Looking Statements

Statements in this press release regarding the Company’s business that are not historical facts, including statements concerning maintaining business profitability and allowing for future investment, are forward-looking statements that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the Company’s Annual Report on Form 10-K.

Source: Advanced Emissions Solutions, Inc.

Investor Contact:

Alpha IR Group
Ryan Coleman or Chris Hodges
312-445-2870
[email protected]



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Eagle Bulk Shipping Inc. to Participate in Bloomberg DryBulk Webinar

STAMFORD, Conn., March 29, 2021 (GLOBE NEWSWIRE) — Eagle Bulk Shipping Inc. (NASDAQ: EGLE) (“Eagle Bulk”, “Eagle” or the “Company”), one of the world’s largest owner-operators within the Supramax / Ultramax drybulk segment, today announced that Gary Vogel, the Company’s Chief Executive Officer will participate in a Bloomberg Intelligence Webinar titled “Will Dry Bulk Finally Deliver?” on April 1, 2021 at 10:30 AM Eastern Time.

During the 1-hour webinar, which will be hosted by Lee Klaskow, Senior Analyst, Bloomberg Intelligence, Mr. Vogel will discuss the current dynamics in the drybulk shipping market, Eagle Bulk’s strategy and competitive positioning and the prospects for continued market strength throughout 2021 and beyond.

The webinar will be broadcast live and available for on-demand replay. It can accessed through a Bloomberg terminal or at no cost using Bloomberg’s website.

Please visit https://www.bloomberg.com/event-registration/?id=106179 to register for the webinar.

About Eagle Bulk Shipping Inc.

Eagle Bulk Shipping Inc. (“Eagle” or the “Company”) is a U.S. based fully integrated shipowner-operator providing global transportation solutions to a diverse group of customers including miners, producers, traders, and end users. Headquartered in Stamford, Connecticut, with offices in Singapore and Copenhagen, Denmark, Eagle focuses exclusively on the versatile mid-size drybulk vessel segment and owns one of the largest fleets of Supramax/Ultramax vessels in the world. The Company performs all management services in-house (including strategic, commercial, operational, technical and administrative) and employs an active management approach to fleet trading with the objective of optimizing revenue performance and maximizing earnings on a risk-managed basis. For further information, please visit our website: www.eagleships.com.

CONTACT

Company Contact:
Frank De Costanzo
Chief Financial Officer
Eagle Bulk Shipping Inc.
Tel. +1 203-276-8100
Email: [email protected]

Media:
Rose and Company
Tel. +1 212-359-2228



Posted on

TG Therapeutics Completes Rolling Submission of Biologics License Application to the U.S. Food and Drug Administration for Ublituximab in Combination with UKONIQ™(umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia

NEW YORK, March 29, 2021 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the completion of the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, in combination with UKONIQTM (umbralisib) , the Company’s once-daily, oral, inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL). The U.S. FDA previously granted Fast Track designation to the combination of ublituximab and umbralisib (U2) for the treatment of adult patients with CLL and orphan drug designation for ublituximab in combination with umbralisib for the treatment of CLL. The BLA submission was based on the results of the UNITY-CLL trial, a global Phase 3 trial evaluating the combination of umbralisib plus ublituximab (U2) compared to obinutuzumab plus chlorambucil in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL). 

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, “The rapid completion of this BLA submission is a critical step forward in our mission to bring our first proprietary combination regimen to patients with both treatment naïve and relapsed or refractory chronic lymphocytic leukemia. The FDA has previously granted the U2 combination both fast track designation as well as orphan drug designation for patients with CLL and we look forward to continuing to work closely with the FDA with the goal of bringing this novel treatment regimen to patients as quickly as possible.” Mr. Weiss continued, “I want to thank the patients, their families and caregivers, as well as the research teams who participated in the UNITY-CLL trial, and also commend the TG team for their hard work to get this submission completed ahead of schedule.”

ABOUT UNITY-CLL PHASE 3 TRIAL
UNITY-CLL is a global Phase 3 randomized controlled clinical trial comparing the combination of ublituximab plus UKONIQ (umbralisib), or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia (CLL). The trial randomized patients into four treatment arms: ublituximab single agent, UKONIQ single agent, ublituximab plus UKONIQ, and an active control arm of obinutuzumab plus chlorambucil. A prespecified interim analysis was conducted to assess the contribution of ublituximab and UKONIQ in the U2 combination arm and allowed for the termination of the single agent arms. Accordingly, the UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil. Approximately 420 subjects enrolled to the two combination arms and approximately 60% of patients were treatment-naïve and 40% were relapsed or refractory. The primary endpoint for this study was superior progression-free survival (PFS) for the U2 combination compared to the control arm to support the submission of the U2 combination in CLL. The trial met its primary endpoint and results were presented at the American Society of Hematology (ASH) Annual Meeting in December 2020. The UNITY-CLL Phase 3 trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

ABOUT CHRONIC LYMPHOCYTIC LEUKEMIA
Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia. It is estimated there will be more than 20,000 new cases of CLL diagnosed in the United States in 2020 and approximately 45,000 new cases globally in 2020.1,2 Although signs and symptoms of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of malignant cells.

ABOUT FAST TRACK

Fast Track is a program designed to expedite the development and review of drugs that treat serious conditions and that demonstrate the potential to address an unmet medical need. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy that may be potentially better than available therapy.

A drug that receives Fast Track designation is eligible for more frequent interactions with the FDA, priority review if relevant criteria are met, and rolling submission of the Biologics License Application or New Drug Application.

ABOUT ORPHAN DRUG DESIGNATION
Orphan drug designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity.

ABOUT TG THERAPEUTICS, INC. 

TG Therapeutics is a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. In addition to an active research pipeline including five investigational medicines across these therapeutic areas, UKONIQTM (umbralisib) received accelerated approval from the U.S. FDA for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed/refractory follicular lymphoma who have received at least three prior lines of systemic therapies. Currently, the Company has programs in Phase 3 development for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and for the treatment of patients with chronic lymphocytic leukemia (CLL) as well as several investigational medicines in Phase 1 clinical development. For more information, visit www.tgtherapeutics.com, and follow us on Twitter @TGTherapeutics and Linkedin.

UKONIQTM is a trademark of TG Therapeutics, Inc.

ABOUT UKONIQ™ (umbralisib)
UKONIQ is the first and only oral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon. PI3K-delta is known to play an important role in supporting cell proliferation and survival, cell differentiation, intercellular trafficking and immunity and is expressed in both normal and malignant B-cells. CK1-epsilon is a regulator of oncoprotein translation and has been implicated in the pathogenesis of cancer cells, including lymphoid malignancies. 

UKONIQ is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.

These indications are approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

IMPORANT SAFETY INFORMATION

Infections: Serious, including fatal, infections occurred in patients treated with UKONIQ. Grade 3 or higher infections occurred in 10% of 335 patients, with fatal infections occurring in <1% . The most frequent Grade ≥3 infections included pneumonia, sepsis, and urinary tract infection. Provide prophylaxis for Pneumocystis jirovecii pneumonia (PJP) and consider prophylactic antivirals during treatment with UKONIQ to prevent CMV infection, including CMV reactivation. Monitor for any new or worsening signs and symptoms of infection, including suspected PJP or CMV, during treatment with UKONIQ. For Grade 3 or 4 infection, withhold UKONIQ until infection has resolved. Resume UKONIQ at the same or a reduced dose. Withhold UKONIQ in patients with suspected PJP of any grade and permanently discontinue in patients with confirmed PJP. For clinical CMV infection or viremia, withhold UKONIQ until infection or viremia resolves. If UKONIQ is resumed, administer the same or reduced dose and monitor patients for CMV reactivation by PCR or antigen test at least monthly.

Neutropenia: Serious neutropenia occurred in patients treated with UKONIQ. Grade 3 neutropenia developed in 9% of 335 patients and Grade 4 neutropenia developed in 9%. Monitor neutrophil counts at least every 2 weeks for the first 2 months of UKONIQ and at least weekly in patients with neutrophil count <1 x 109/L (Grade 3-4) neutropenia during treatment with UKONIQ. Consider supportive care as appropriate. Withhold, reduce dose, or discontinue UKONIQ depending on the severity and persistence of neutropenia.

Diarrhea or Non-Infectious Colitis: Serious diarrhea or non-infectious colitis occurred in patients treated with UKONIQ. Any grade diarrhea or colitis occurred in 53% of 335 patients and Grade 3 occurred in 9%. For patients with severe diarrhea (Grade 3, i.e., > 6 stools per day over baseline) or abdominal pain, stool with mucus or blood, change in bowel habits, or peritoneal signs, withhold UKONIQ until resolved and provide supportive care with antidiarrheals or enteric acting steroids as appropriate. Upon resolution, resume UKONIQ at a reduced dose. For recurrent Grade 3 diarrhea or recurrent colitis of any grade, discontinue UKONIQ. Discontinue UKONIQ for life-threatening diarrhea or colitis.

Hepatotoxicity: Serious hepatotoxicity occurred in patients treated with UKONIQ. Grade 3 and 4 transaminase elevations (ALT and/or AST) occurred in 8% and <1%, respectively, in 335 patients. Monitor hepatic function at baseline and during treatment with UKONIQ. For ALT/AST greater than 5 to less than 20 times ULN, withhold UKONIQ until return to less than 3 times ULN, then resume at a reduced dose. For ALT/AST elevation greater than 20 times ULN, discontinue UKONIQ.

Severe Cutaneous Reactions: Severe cutaneous reactions, including a fatal case of exfoliative dermatitis, occurred in patients treated with UKONIQ. Grade 3 cutaneous reactions occurred in 2% of 335 patients and included exfoliative dermatitis, erythema, and rash (primarily maculo-papular). Monitor patients for new or worsening cutaneous reactions. Review all concomitant medications and discontinue any potentially contributing medications. Withhold UKONIQ for severe (Grade 3) cutaneous reactions until resolution. Monitor at least weekly until resolved. Upon resolution, resume UKONIQ at a reduced dose. Discontinue UKONIQ if severe cutaneous reaction does not improve, worsens, or recurs. Discontinue UKONIQ for life-threatening cutaneous reactions or SJS, TEN, or DRESS of any grade. Provide supportive care as appropriate.

Allergic Reactions Due to Inactive Ingredient FD&C Yellow No. 5: UKONIQ contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons, frequently in patients who also have aspirin hypersensitivity.

Embryo-fetal Toxicity: Based on findings in animals and its mechanism of action, UKONIQ can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females and males with female partners of reproductive potential to use effective contraception during treatment and for at least one month after the last dose.

Serious adverse reactions occurred in 18% of 221 patients who received UKONIQ. Serious adverse reactions that occurred in ≥2% of patients were diarrhea-colitis (4%), pneumonia (3%), sepsis (2%), and urinary tract infection (2%). Permanent discontinuation of UKONIQ due to an adverse reaction occurred in 14% of patients. Dose reductions of UKONIQ due to an adverse reaction occurred in 11% of patients. Dosage interruptions of UKONIQ due to an adverse reaction occurred in 43% of patients.

The most commonadverse reactions (>15%), including laboratory abnormalities, in 221 patients who received UKONIQ were increased creatinine (79%), diarrhea-colitis (58%, 2%), fatigue (41%), nausea (38%), neutropenia (33%), ALT increase (33%), AST increase (32%), musculoskeletal pain (27%), anemia (27%), thrombocytopenia (26%), upper respiratory tract infection (21%), vomiting (21%), abdominal pain (19%), decreased appetite (19%), and rash (18%).

Lactation: Because of the potential for serious adverse reactions from umbralisib in the breastfed child, advise women not to breastfeed during treatment with UKONIQ and for at least one month after the last dose.

Please visit www.tgtherapeutics.com/prescribing-information/uspi-ukon for full Prescribing Information and Medication Guide.

1 Cancer Stat Facts: Leukemia — Chronic Lymphocytic Leukemia (CLL). National Cancer Institute Surveillance, Epidemiology, and End Results Program website. https://seer.cancer.gov/statfacts/html/clyl.html. Accessed October 26, 2020.
2 EpiCast Report: Chronic Lymphocytic Leukemia – Epidemiology Forecast to 2025. Available at: https://store.globaldata.com/report/gdhcer164-17–epicast-report-chronic-lymphocytic-leukemia-epidemiology-forecast-to-2025/.


Cautionary Statement

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements relating to the BLA submission of ublituximab in combination with UKONIQTM (umbralisib), the clinical development of our product candidates, and anticipated milestones. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission, factors that could cause our actual results to differ materially are the following: risk that the FDA will not accept the BLA submission of ublituximab in combination with UKONIQ in patients with CLL, or if accepted, the risk that the FDA will not approve the BLA submission; the risk that fast track designation may not actually lead to a faster regulatory review or approval process; the risk that safety issues or trends will be observed in the UNITY-CLL study or in other studies that prevent approval of ublituximab in combination with UKONIQ; the risk that ublituximab in combination with UKONIQ, or any other product candidates, will not be commercially successful if approved; the risk that the differentiated tolerability profile for UKONIQ previously observed in clinical trials will not be reproduced in the UNITY-CLL trial or any other on-going studies; our ability to successfully and cost effectively complete preclinical and clinical trials; the uncertainties inherent in research and development; and the risk that the ongoing COVID-19 pandemic and associated government control measures have an adverse impact on our research and development plans or commercialization efforts. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in our other filings with the U.S. Securities and Exchange Commission.

Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

CONTACT:

Investor Relations

Email: [email protected]
Telephone: 1.877.575.TGTX (8489), Option 4

Media Relations:

Email: [email protected]
Telephone: 1.877.575.TGTX (8489), Option 6



Posted on

Arcosa, Inc. Announces Proposed Offering of $400 Million of Senior Notes

Arcosa, Inc. Announces Proposed Offering of $400 Million of Senior Notes

DALLAS–(BUSINESS WIRE)–
Arcosa, Inc. (NYSE: ACA) (“Arcosa”), a provider of infrastructure-related products and solutions, today announced that it intends to commence, subject to market conditions and other factors, a private offering of $400 million aggregate principal amount of senior notes due 2029 (the “Notes”).

Arcosa intends to use the net proceeds of the offering to fund the payment of the purchase price of the previously announced acquisition of StonePoint Ultimate Holding, LLC and affiliated entities (“StonePoint”), which is expected to close in April 2021, to repay any borrowings that may be outstanding under a new $150 million 364-day credit facility at the closing of the offering of the Notes, and to use any remaining net proceeds for general corporate purposes, which may include repayment in whole, or in part, of amounts outstanding under its existing revolving credit facility and other potential strategic investments. The closing of the offering is not conditioned upon the completion of the StonePoint acquisition. The Notes will be senior unsecured obligations of Arcosa and will initially be guaranteed on a senior unsecured basis by each of Arcosa’s domestic subsidiaries that is a guarantor under its existing senior credit facility.

The Notes and the related guarantees are being offered and sold only to persons reasonably believed to be “qualified institutional buyers” in reliance on Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”), and outside the United States to certain non-U.S. persons in compliance with Regulation S under the Securities Act. The Notes and the related guarantees have not been and will not be registered for sale under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, the Notes or any other securities, and shall not constitute an offer to sell, solicitation of an offer to buy, or sale of any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offers of the Notes will be made only by means of a private offering memorandum.

About Arcosa

Arcosa, Inc. (NYSE: ACA), headquartered in Dallas, Texas, is a provider of infrastructure-related products and solutions with leading positions in construction, engineered structures, and transportation markets. Arcosa reports its financial results in three principal business segments: Construction Products, Engineered Structures, and Transportation Products. For more information, visit www.arcosa.com.

Some statements in this release, which are not historical facts, are “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements about Arcosa’s estimates, expectations, beliefs, intentions or strategies for the future. Arcosa uses the words “anticipates,” “assumes,” “believes,” “estimates,” “expects,” “intends,” “forecasts,” “may,” “will,” “should,” “guidance,” “outlook,” “strategy,” and similar expressions to identify these forward-looking statements. Forward-looking statements speak only as of the date of this release, and Arcosa expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statement contained herein, except as required by federal securities laws. Forward-looking statements are based on management’s current views and assumptions and involve risks and uncertainties that could cause actual results to differ materially from historical experience or our present expectations, including but not limited to assumptions, risks and uncertainties regarding the completion of the StonePoint acquisition; the impact of the COVID-19 pandemic on Arcosa’s customer demand for Arcosa’s products and services, Arcosa’s supply chain, Arcosa’s employees’ ability to work because of COVID-19 related illness, the health and safety of our employees, the effect of governmental regulations imposed in response to the COVID-19 pandemic; assumptions, risks and uncertainties regarding achievement of the expected benefits of Arcosa’s spin-off from Trinity; tax treatment of the spin-off; market conditions and customer demand for Arcosa’s business products and services; the cyclical nature of, and seasonal or weather impact on, the industries in which Arcosa competes; competition and other competitive factors; governmental and regulatory factors; changing technologies; availability of growth opportunities; market recovery; ability to improve margins; risks and uncertainties related to the capital markets generally; whether Arcosa will consummate the offering; the anticipated terms of the Notes and the anticipated use of proceeds; and Arcosa’s ability to execute its long-term strategy, and such forward-looking statements are not guarantees of future performance. For further discussion of such risks and uncertainties, see “Risk Factors” and the “Forward-Looking Statements” section of “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Arcosa’s Form 10-K for the year-ended December 31, 2020, as may be revised and updated by Arcosa’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.

INVESTORS

Scott C. Beasley

Chief Financial Officer

Gail M. Peck

SVP, Finance & Treasurer

T 972.942.6500

[email protected]

David Gold

ADVISIRY Partners

T 212.661.2220

[email protected]

MEDIA

[email protected]

KEYWORDS: United States North America Texas

INDUSTRY KEYWORDS: Construction & Property Other Manufacturing Other Transport Engineering Logistics/Supply Chain Management Other Construction & Property Transport Manufacturing

MEDIA:

Posted on

Nomad Foods to Acquire Fortenova’s Frozen Food Business Group

 Nomad Foods to Acquire Fortenova’s Frozen Food Business Group

 Further reinforces Nomad’s European frozen food leadership with multiple levers for value creation & synergies

Market leading brands Ledo and Frikom provide entry into attractive Central & Eastern European markets

Expect 2021 combined Adjusted EPS above $2.00 per share on an annualized basis

Expected to be high-single digit % accretive to Adjusted EPS in Year 1, before synergies

FELTHAM, England–(BUSINESS WIRE)–
Nomad Foods Limited (NYSE: NOMD) announced today that it has entered into an agreement to acquire Fortenova Group’s Frozen Food Business Group (FFBG) for aggregate consideration of approximately €615 million on a debt-free, cash free basis.

FFBG is a leading European frozen food portfolio operating in attractive markets new to Nomad, including Croatia, Serbia and Bosnia & Herzegovina, Hungary, Slovenia, Kosovo, North Macedonia and Montenegro. Its two anchor brands, Ledo and Frikom, have unparalleled consumer awareness and #1 market share in many of these markets and offer a broad range of frozen food products including fish, fruits, vegetables, ready meals, pastry and ice cream.

Stéfan Descheemaeker, Nomad Foods’ Chief Executive Officer, stated, “The acquisition of FFBG reinforces Nomad’s European frozen food leadership while strategically expanding our portfolio into attractive new markets and creating an exciting new category adjacency in ice cream. Like Birds Eye, Findus and iglo, Ledo and Frikom are institutions in their respective markets with strong consumer awareness and #1 market share. Similar to Nomad, FFBG is singularly focused on frozen food, a fantastic category that is aligned with consumer trends including convenience and sustainability. We plan to leverage our combined pan-European scale, commercial expertise and passion for frozen food while harnessing the unique local characteristics and traditions of FFBG’s brands.”

Noam Gottesman, Nomad Foods’ Co-Chairman and Founder, commented, “We are delighted to announce this acquisition, which is consistent with our growth strategy and builds on our five-year track record of top-tier shareholder value creation. This transaction provides a natural extension to our existing business and creates a new platform for future expansion within Central and Eastern Europe. It also introduces us to ice cream, an exciting new category which opens new potential avenues for growth. Following the acquisition, our annual revenue will approach €3 billion, nearly doubling the revenue base of Iglo Group, our initial anchor acquisition in 2015. We are proud of what we have accomplished so far, and we believe there is much more to come. We look forward to welcoming the FFBG team into the Nomad family.”

This acquisition is highly strategic and financially impactful for Nomad:

  • Expansion into New and Attractive Central & Eastern European markets. FFBG is the leading frozen food company in several European markets, including Croatia, Serbia and Bosnia & Herzegovina, Hungary, Slovenia, Kosovo, North Macedonia and Montenegro. These are large and attractive markets where consumer demand for frozen food is developing, which creates a compelling long-term growth opportunity. Management expects FFBG’s organic growth to be in the mid-single digits range, double the 2-3% organic growth profile of Nomad’s existing business. The acquisition of FFBG will expand Nomad’s portfolio into this attractive region while creating a strategic platform for further expansion within Central & Eastern Europe.
  • Ledo and Frikom Brands are the Clear Frozen Food Leaders. FFBG’s core brands, Ledo and Frikom, have strong consumer awareness and #1 market share in many of their respective markets. Ledo and Frikom share many of the same characteristics as Nomad’s existing power brands Birds Eye, Findus and iglo which are sold across Western Europe. As a result, FFBG’s brands stand to benefit from the commercial playbook that has enabled Nomad’s profitable growth to-date, including portfolio management, innovation, R&D, net revenue management, and media efficiency.
  • Entry into Ice Cream Creates an Exciting New Product Adjacency and is Seasonally Complementary to Nomad’s Core Savory Portfolio. Ice Cream, a new category to Nomad, represents approximately 50% of FFBG’s revenues and will account for approximately 5% of the combined annual revenue base. This profitable category is highly synergistic with savory frozen food in FFBG’s core markets and provides Nomad with new category expertise. Further, the seasonal concentration of ice cream profits in the summer months will be seasonally complementary to Nomad’s existing frozen savory portfolio, which is skewed to the winter months, namely Q1 and Q4.
  • Multiple Levers for Value Creation and Synergies. Management sees an opportunity to expand FFBG’s Adjusted EBITDA base by approximately 50%, partly driven by an estimated €15 million of annual run-rate synergies by 2024 through a combination of scale, operational excellence, commercial optimization, and expense management.
  • Anticipate High-Single Digit % Accretion in Year 1 with 2021 Combined Annual Adjusted EPS Above $2.00 Per Share. FFBG is expected to generate annual revenue and Adjusted EBITDA of €279 million and €53 million, respectively in 2021. Management anticipates the transaction to enhance Nomad’s long-term organic revenue and Adjusted EBITDA growth profiles while also being high-single digit % accretive to Adjusted EPS in Year 1, before synergies. Combined 2021 Adjusted EPS is expected to exceed $2.00 per share on an annualized basis.
  • Firmly Aligned with Management’s Disciplined Acquisition Criteria. The acquisition of FFBG aligns with management’s articulated strategy of expanding Nomad’s frozen food portfolio into new geographies, categories and channels. FFBG has a market leading position, an attractive growth profile and generates strong cash flow consistent with Nomad’s investment criteria. Furthermore, the implied transaction multiple of under 10x EBITDA, including run-rate synergies, reflects the Company’s commitment to valuation discipline.

Management intends to update guidance on the combined entities for the current year upon closing of the transaction, which is expected to be completed during the third quarter of 2021 subject to approval of a majority of the depositary receipt holders of the ultimate parent of the seller and satisfactions of other certain closing conditions. The purchase price is expected to be funded through cash on hand and debt. The transaction has been unanimously approved by the board of directors of the seller which consists of representatives of more than a majority of the depositary receipt holders of the ultimate parent of the seller.

Morgan Stanley acted as financial advisor and Norton Rose Fulbright, Divjak Topic Bahtijarevic & Krka Law Firm and BDK Advokati are acting as legal advisors to Nomad Foods on the transaction.

Conference Call and Webcast

The Company will host a conference call with members of the executive management team to discuss the transaction today, Monday, March 29, 2021 at 1:30 p.m. BST (8:30 a.m. Eastern Daylight Time). Investors interested in participating in the live call can dial +1-877-451-6152 from North America. International callers can dial +1-201-389-0879.

In addition, the call will be broadcast live over the Internet hosted at the “Investor Relations” section of the Company’s website at http://www.nomadfoods.com. The webcast will be archived for 30 days. A replay of the conference call will be available on the Company website for two weeks following the event and can be accessed by listeners in North America by dialing +1-844-512-2921 and by international listeners by dialing +1-412-317-6671; the replay pin number is 13718228.

About Nomad Foods

Nomad Foods (NYSE: NOMD) is Europe’s leading frozen foods company. The company’s portfolio of iconic brands, which includes Birds Eye, Findus, iglo, Aunt Bessie’s and Goodfella’s, have been a part of consumers’ meals for generations, standing for great tasting food that is convenient, high quality and nutritious. Nomad Foods is headquartered in the United Kingdom. Additional information may be found at www.nomadfoods.com.

Forward-Looking Statements and Disclaimers

Certain statements in this announcement are forward-looking statements which are based on the Company’s expectations, intentions and projections regarding its future performance, anticipated events or trends and other matters that are not historical facts, including expectations regarding: (i) the Company’s ability to create shareholder value through a combination of organic growth and the accretive deployment of capital; (ii) the Company’s ability to replicate its growth model, expand its geographic reach within Central and Eastern Europe and extend its product offering and brand family; (iii) the success of the Company’s strategic initiatives and growth strategy, including the impact of the acquisition on long-term value creation and long-term growth; (iv) the organic growth of FFBG; (v) the future operating and financial performance of the Company, including the expected annual revenue and adjusted EBITDA of FFBG in 2021; (vi) achievement of run-rate synergies through a combination of scale, operational excellence, commercial optimization and expense management; and (vii) the funding and timing of closing of the acquisition. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements, including (i) the operating and financial performance of the Company following the acquisition is worse than anticipated; (ii) the Company is not able to achieve the planned synergies; (iii) economic conditions, competition and other risks that may affect the Company’s future performance; and (iv) the other risks and uncertainties disclosed in the Company’s public filings and any other public disclosures by the Company. Given these risks and uncertainties, prospective investors are cautioned not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date of such statements and, except as required by applicable law, the Company does not undertake any obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

This press release contains forward-looking non-IFRS financial measures within the meaning of Regulation G promulgated by the Securities and Exchange Commission including combined adjusted EBITDA and combined revenues. The Company uses certain non-IFRS financial measures that are included in this press release and the additional financial information both in explaining its results to shareholders and the investment community and in its internal evaluation and management of its businesses. The Company does not provide reconciliations of forward-looking non-U.S. IFRS financial information due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations, the amount of which, based on historical experience, could be significant.

Investor Relations Contacts

Taposh Bari, CFA

Nomad Foods Limited

+1-718-290-7950

John Mills

ICR, Partner

+1-646-277-1254

Media Contact

Felipe Ucros

Gladstone Place Partners

+1-212-230-5930

RELATED LINKS

http://www.nomadfoods.com

KEYWORDS: United Kingdom Europe

INDUSTRY KEYWORDS: Retail Supermarket Food/Beverage

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