Author: aweinsoff@channelchek.com

Release – GeoVax Receives Notice of Allowance for Malaria Vaccine Patent

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

  • Last updated: 28 August 2023 13:12
  • Created: 28 August 2023 12:59
  • Hits: 12

Patent Covers Multiple Component Vaccine for Both Prevention and Treatment

Atlanta, GA, August 28, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/726,254 titled “Compositions and Methods for Generating an Immune Response to Treat or Prevent Malaria”.

The allowed claims cover compositions comprising GeoVax’s modified vaccinia Ankara (MVA) vector expressing Plasmodium antigens and methods of inducing an immune response to malaria utilizing the compositions. The compositions and methods covered in the allowed claims are useful both prophylactically and therapeutically and may be used to prevent and/or treat malaria.

According to data from the World Health Organization, globally, malaria causes 227 million infections and 619,000 deaths annually. Despite decades of vaccine research, vaccine candidates have failed to induce substantial protection. Most of these vaccines are based on individual proteins that induce immune responses targeting only one stage of the malaria parasite’s life cycle. GeoVax’s MVA-VLP malaria vaccine candidates incorporate antigens derived from multiple stages of the parasite’s life cycle and are designed to induce an immune response with durable functional antibodies and CD4+ and CD8+ T cell responses, all hallmarks of an ideal vaccine-induced immune response.

David Dodd, GeoVax President and CEO, commented, “We remain strongly committed to advancing innovation towards improving public health worldwide and this patent allowance reflects a potentially significant advancement relative to malaria prevention. Our development priorities continue to be our next-generation COVID-19 vaccine, currently in Phase 2 clinical trials, and our cancer immunotherapy program, with Gedeptin® as our lead product in a Phase 1/2 clinical trial for Advanced Head and Neck cancer. However, developing vaccines against global public health threats, such as malaria, is also part of our longer-term commitment focus. This patent allowance adds to our growing portfolio of wholly owned, co-owned, and in-licensed intellectual property, now standing at over 115 granted or pending patent applications spread over 24 patent families.”

About the GV-MVA-VLPTM Platform

GeoVax’s GV-MVA-VLPTM vaccine platform utilizes modified vaccinia Ankara (MVA), a large virus capable of carrying several vaccine antigens, that expresses proteins that assemble into virus-like particles (VLP) immunogens in the person receiving the vaccine. The production of VLPs in the person being vaccinated can mimic the virus production that occurs in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP derived vaccines can elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Contact:

GeoVax Labs, Inc.

investor@geovax.com

678-384-7220

Release – Maple Gold Announces the Appointments of Kiran Patankar as Interim President & CEO and Michael Rukus as Interim CFO

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MGMLF

Vancouver, British Columbia–(Newsfile Corp. – August 28, 2023) – Maple Gold Mines Ltd. (TSXV: MGM) (OTCQB: MGMLF) (FSE: M3G) (“Maple Gold” or the “Company“) today announced the immediate departure of Matthew Hornor as President, Chief Executive Officer and a Director of Maple Gold and the concurrent appointment of Kiran Patankar, an experienced mining executive and current Chief Financial Officer of Maple Gold, as its Interim President and Chief Executive Officer. The Company also announced the appointment of Michael Rukus, a Chartered Professional Accountant (CPA) and current Corporate Controller of Maple Gold, as its Interim Chief Financial Officer to fill the vacancy created by Mr. Patankar’s appointment.

Mr. Patankar brings to the role an extensive public company leadership, investment banking and capital markets background and a diverse financial, technical, and strategic skill set, including mergers and acquisitions, capital raising, project evaluation and development, financial controls and reporting, stakeholder engagement and corporate governance. His appointment will ensure a smooth transition and operational continuity while the Board pursues an active strategy to unlock value through prudent capital allocation and disciplined exploration and development of the Company’s district-scale gold projects located in Québec, Canada.

“After careful review and discussion, the Independent Directors unanimously concluded that a leadership transition is in the best interests of the Company’s shareholders and stakeholders,” stated Michelle Roth, Maple Gold’s Chairperson, speaking on behalf of the Board. “The Board would like to thank Mr. Patankar and Mr. Rukus for stepping into their respective positions and looks forward to working with them in their expanded roles as we execute on our value creation initiatives and deliver on the Company’s enormous growth potential.”

Mr. Patankar has more than 15 years of senior leadership experience in the mining industry. He has served as Maple Gold’s Chief Financial Officer since 2022, after serving as the Company’s Senior Vice President, Growth Strategy since 2021. From 2015 to 2018, Mr. Patankar served as President, CEO and a Director of two TSX-V listed gold exploration and development companies, where he led growth initiatives and orchestrated successful company turnarounds. As an investment banker with leading Canadian and global financial institutions from 2007 to 2014, he worked exclusively with mining companies on strategic corporate matters and executed M&A and corporate finance transactions totaling more than $3 billion in value. Mr. Patankar holds a Bachelor of Science in Geological Engineering from the Colorado School of Mines and an MBA from the Yale School of Management.

Mr. Rukus has more than 15 years of progressive leadership experience in finance and accounting, including over 10 years in the exploration and mining industry. He has led and directed global accounting and finance teams across multiple jurisdictions and has helped companies drive efficient and comprehensive financial plans and analysis to meet their strategic goals. Mr. Rukus attained a Bachelor of Arts from Simon Fraser University with majors in both Economics and Business Administration and holds Certified Public Accountant (CPA) and Certified General Accountant (CGA) designations.

About Maple Gold

Maple Gold Mines Ltd. is a Canadian advanced exploration company in a 50/50 joint venture with Agnico Eagle Mines Limited to jointly advance the district-scale Douay and Joutel gold projects located in Québec’s prolific Abitibi Greenstone Gold Belt. The projects benefit from exceptional infrastructure access and boast ~400 km2 of highly prospective ground including an established gold resource at Douay (SLR 2022) that holds significant expansion potential as well as the past-producing Eagle, Telbel and Eagle West mines at Joutel. In addition, the Company holds an exclusive option to acquire 100% of the Eagle Mine Property.

The district-scale property package also hosts a significant number of regional exploration targets along a 55 km strike length of the Casa Berardi Deformation Zone that have yet to be tested through drilling, making the project ripe for new gold and polymetallic discoveries. The Company is well capitalized and is currently focused on carrying out exploration and drill programs to grow resources and make new discoveries to establish an exciting new gold district in the heart of the Abitibi. For more information, please visit www.maplegoldmines.com.

ON BEHALF OF MAPLE GOLD MINES LTD.

“Michelle Roth”

Michelle Roth, Chairperson

For Further Information Please Contact:

Mr. Kiran Patankar
Interim President & CEO
Tel: 604.639.2536
Email: kpatankar@maplegoldmines.com

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS PRESS RELEASE.

Forward Looking Statements:

This press release contains “forward-looking information” and “forward-looking statements” (collectively referred to as “forward-looking statements”) within the meaning of applicable Canadian securities legislation in Canada, including statements about exploration work and results from current and future work programs. Forward-looking statements are based on assumptions, uncertainties and management’s best estimate of future events. Actual events or results could differ materially from the Company’s expectations and projections. Investors are cautioned that forward-looking statements involve risks and uncertainties. Accordingly, readers should not place undue reliance on forward-looking statements. For a more detailed discussion of such risks and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements, refer to Maple Gold Mines Ltd.’s filings with Canadian securities regulators available on www.sedarplus.ca or the Company’s website at www.maplegoldmines.com. The Company does not intend, and expressly disclaims any intention or obligation to, update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/178645

Release – Salem Media Group Announces Plan to Sell Its Greenville Radio Stations

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SALM

August 23, 2023 3:32pm EDT

IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM) announced today that it entered into an agreement to transfer the ownership of its Greenville-Spartanburg stations, WGTK-FM, WRTH-FM, and WLTE-FM to Educational Media Foundation (EMF). Salem Media CEO David Santrella stated, “We have enjoyed our years in the Greenville-Spartanburg market but have made the strategic decision to divest our interests there. As we do, we are grateful to be able to place these signals in the hands of Educational Media Foundation (EMF) who share a like-minded mission with Salem through their music programming. We are also thankful to our Greenville-Spartanburg staff for their many years of service.”

ABOUT SALEM MEDIA GROUP:

Salem Media Group is America’s leading multimedia company specializing in Christian and conservative content, with media properties comprising radio, digital media and book and newsletter publishing. Each day Salem serves a loyal and dedicated audience of listeners and readers numbering in the millions nationally. With its unique programming focus, Salem provides compelling content, fresh commentary and relevant information from some of the most respected figures across the Christian and conservative media landscape. Learn more about Salem Media Group, Inc. at www.salemmedia.com, Facebook and Twitter.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230821844514/en/

Company Contact:
Evan D. Masyr
Executive Vice President and Chief Financial Officer
(805) 384-4512
evan@salemmedia.com

Source: Salem Media Group, Inc.

Released August 23, 2023

Release – Baudax Bio Announces Distribution of Series C Preferred Stock to Holders of its Common Stock

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BXRX

 Download as PDF

August 23, 2023 8:00am EDT

MALVERN, Pa., Aug. 23, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced that its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series C Preferred Stock, par value $0.01 per share, for each outstanding share of the Company’s common stock held of record as of 5:00 p.m. Eastern Time on September 5, 2023. The shares of Series C Preferred Stock will be distributed to such recipients at 5:00 p.m. Eastern Time on September 7, 2023. The outstanding shares of Series C Preferred Stock will vote together with the outstanding shares of the Company’s common stock, as a single class, exclusively with respect to a proposal to approve a reverse stock split, as well as any proposal to adjourn any meeting of shareholders called for the purpose of voting on the reverse stock split, and will not be entitled to vote on any other matter, except to the extent required under the Pennsylvania Business Corporation Law. Subject to certain limitations, each outstanding share of Series C Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series C Preferred Stock).

All shares of Series C Preferred Stock that are not present in person or by proxy at the meeting of shareholders held to vote on the reverse stock split as of immediately prior to the opening of the polls at such meeting will automatically be redeemed by the Company and shall have no voting power. Any outstanding shares of Series C Preferred Stock that have not been so redeemed will be redeemed if such redemption is ordered by the Company’s Board of Directors or automatically upon the approval by the Company’s shareholders of an amendment to the Company’s articles of incorporation effecting the reverse stock split at such meeting.

The Series C Preferred Stock will be uncertificated, and no shares of Series C Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Company’s common stock held by such holder. In that case, a number of one one-thousandths of a share of Series C Preferred Stock equal to the number of shares of the Company’s common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.

Further details regarding the Series C Preferred Stock will be contained in a report on Form 8-K to be filed by the Company with the Securities and Exchange Commission.

About Baudax Bio

Baudax Bio/TeraImmune is a biotech company focused on innovative products for certain auto-immune conditions, of which many but not all, are orphan drug conditions as well as acute care and related settings. The combined company will further the development of Treg therapy specific to HA (pipeline candidate TI-168). TI-168 is a next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitor. By combining the patented Treg culture method and TeraImmune designed FVIII-specific TCR, the Company has successfully demonstrated the therapeutic concept of FVIII TCR-Treg therapy in controlling of FVIII ADA in a hemophilic animal model. The lead program TI-168 has shown encouraging pre-clinical data and the FDA has cleared an IND to commence a Phase 1/2a clinical trial for the treatment of Hemophilia A with inhibition.

In addition, over time, the combined company will advance the development of TeraImmune’s innovative immune-cell therapies, leveraging a dual Treg manufacturing platform consisting of both natural regulatory Tregs isolated from patients and induced Tregs converted from a patient’s T-effector (“Teff”) cells. This Treg platform technology is designed for conditions that suppress unwanted immune reactions and includes the allogenic, or off-the-shelf, Tregs obtained from Umbilical Cord Blood for the treatment of skin diseases such as Atopic Dermatitis. For more information, please visit www.baudaxbio.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio or its management, and TeraImmune or its management, are intended to identify such forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Baudax Bio’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, clinical results and other future conditions. There are a number of important factors that could cause Baudax Bio’s actual results to differ materially from those indicated or implied by such forward-looking statements including, without limitation: whether Baudax Bio will be able to successfully integrate the TeraImmune operations and realize the anticipated benefits of the acquisition of TeraImmune; whether Baudax Bio’s shareholders approve the conversion of the Series X Preferred Stock and the required cash payment of the then-current fair value of the Series X Preferred Stock if such approval is not provided; whether Baudax Bio’s cash resources will be sufficient to fund Baudax Bio’s continuing operations and the newly acquired TeraImmune operations, including the liabilities of TeraImmune incurred in connection with the completion of the Merger; whether Baudax Bio’s collaborations will be successful; whether Baudax Bio will be able to advance its current product candidate pipeline through preclinical studies and clinical trials, that interim results may not be indicative of final results in clinical trials, that earlier-stage trials may not be indicative of later-stage trials, the approvability of product candidates; whether Baudax Bio will be able to comply with the financial and other covenants under its credit facility; and whether Baudax Bio will be able to maintain its listing on the Nasdaq Capital Market. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Baudax Bio may not actually achieve the forecasts disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Baudax Bio’s most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the SEC. Any forward looking statement speaks only as of the date on which it was made. Neither Baudax Bio, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Baudax Bio’s views as of any date subsequent to the date hereof.

Investor Relations Contact:

Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

Release – Snail, Inc. Announces Wandering Wizard to Showcase Latest Games at PAX West 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SNAL

August 22, 2023 at 7:52 AM EDT

PDF Version

CULVER CITY, Calif., Aug. 22, 2023 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail” or “the Company”), a leading, global independent developer and publisher of interactive digital entertainment, today announced that its indie publishing sub-label, Wandering Wizard, will be showcasing its latest games, Survivor Mercs, West Hunt and Expedition Agartha, at the upcoming PAX West 2023 event in Seattle, running from September 1 through 4, 2023.

Survivor Mercs, developed by Wolperginger Games, is an Early Access roguelite action game that blends the bullet-heaven and extraction shooter genre for a challenging single-player experience where no two gameplay runs are alike. West Hunt, developed by NewGen Studio, is a one-to-six-player social deduction game set in the Old West. The game allows players to immerse themselves in the Wild West as hardworking townsfolk, sheriffs, or outlaws. Expedition Agartha, developed by Matrioshka Games, is an Early Access multiplayer First Person Looter Survival game that challenges players to explore a mysterious island in the Lost Continent of Mu and uncover the secrets of Agartha.

After the commendable reception at PAX East 2023 held in Boston earlier in March, Wandering Wizard is excited to reconnect with fans and industry professionals from the West Coast at this notable event and generate buzz around its latest games. PAX West 2023 is one of the largest gaming conventions in North America, providing an ideal opportunity for Wandering Wizard to promote its games and expand its reach.

At booth 608 on the 4th Floor of the Seattle Convention Center, Wandering Wizard will provide visitors with the opportunity to get hands-on gameplay experience with West Hunt and Expedition Agartha. Additionally, a demo presentation of Survivor Mercs will be available at the booth. The onsite team from Wandering Wizard will be available for discussion, offering insight into game development. In addition, visitors stand a chance to win Early Access codes, exclusive merchandise, both on-site and online.

Jim Tsai, Chief Executive Officer of Snail, commented: “The upcoming PAX West 2023 provides an unparalleled platform for Wandering Wizard to engage with the expansive gaming community. Our dedicated team at Wandering Wizard strives to deliver top-tier gaming experiences with a distinct emphasis on player feedback and sustained improvement. As we approach PAX West 2023, we look forward to showcasing our game offerings and enhancing our visibility.”

About Snail, Inc.

Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. The statements Snail makes regarding the following matters are forward-looking by their nature: growth prospects and strategies; launching new games and additional functionality to games that are commercially successful, including the launch of ARK: Survival Ascended, ARK: The Animated Series and ARK 2; expectations regarding significant drivers of future growth; its ability to retain and increase its player base and develop new video games and enhance existing games; competition from companies in a number of industries, including other game developers and publishers and both large and small, public and private Internet companies; its relationships with third-party platforms such as Xbox Live and Game Pass, PlayStation Network, Steam, Epic Games Store, the Apple App Store, the Google Play Store, My Nintendo Store and the Amazon Appstore; expectations for future growth and performance; and assumptions underlying any of the foregoing.

Contacts:

Investors:

investors@snail.com

Release – ZyVersa Therapeutics Reports Second Quarter 2023 Corporate and Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Aug 21, 2023

PDF Version

Key Highlights:

  • Advanced clinical development initiatives for Cholesterol Efflux Mediator™ VAR 200, with planned initiation of a Phase 2a clinical trial in diabetic kidney disease (DKD) in the first quarter of 2024
  • Granted a European patent covering Phase 2a-ready Cholesterol Efflux MediatorTM VAR 200 (2-hydroxypropyl-beta-cyclodextrin) for use in diabetic nephropathy/diabetic kidney disease
  • Published new white paper detailing the critical role of inflammasome ASC in inflammatory diseases, and the potential of Inflammasome ASC Inhibitor IC 100 to address multiple CNS and non-CNS diseases
  • Added Dr. Douglas Golenbock to ZyVersa’s Inflammatory Disease Scientific Advisory Board to support advancement of Inflammasome ASC Inhibitor IC 100

WESTON, Fla., Aug. 21, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq-GM: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, today provides a corporate update and reports financial results for the second quarter of 2023 ending June 30, 2023.

“The second quarter of 2023 was a period of continued progress at ZyVersa as we completed key corporate, developmental, regulatory and financial initiatives designed to position the company to achieve value-building milestones involving our Cholesterol Efflux Mediator™ VAR 200 and Inflammasome ASC Inhibitor IC 100,” said Stephen C. Glover, Co-founder, Chairman, Chief Executive Officer, and President of ZyVersa. “We are pleased to report our VAR 200 program is progressing as planned, and we anticipate initiation of a Phase 2a clinical trial in diabetic kidney disease (DKD) in the first quarter of 2024. For our Inflammasome ASC Inhibitor IC 100, we are completing final preclinical activities to enable submission of an Investigational New Drug (“IND”) application and initiation of a first-in-human clinical trial in 2024.”

Mr. Glover concluded: “This is a very exciting time for ZyVersa as we seek to create shareholder value through the development of first-in-class drugs at the forefront of renal and inflammatory diseases. Significant value-building milestones are expected to be achieved for Cholesterol Efflux MediatorTM VAR 200 and Inflammasome ASC Inhibitor IC 100 over the remainder of 2023 and early 2024 to increase shareholder value.”

SECOND QUARTER AND RECENT PROGRAM UPDATES

Phase 2a-Ready Cholesterol Efflux Mediator™ VAR 200

  • European patent was granted covering VAR 200 for use in diabetic nephropathy/diabetic kidney disease
  • Planning and key initiatives are underway to initiate a Phase 2a clinical trial in patients with DKD, with initial patient enrollment expected by first quarter 2024

Inflammasome ASC Inhibitor IC 100

  • Continued to provide support for the mechanism of action of Inflammasome ASC Inhibitor IC 100 with consistent evidence across peer-reviewed academic literature on the role of inflammasomes in the pathogenesis of a broad range of diseases including Parkinson’s disease, Alzheimer’s disease, lupus nephritis, peripheral arterial disease, juvenile idiopathic arthritis, and alcoholic hepatitis
  • Enhanced Inflammatory Disease Scientific Advisory Board with the addition of Dr. Douglas Golenbock, a pioneer and internationally recognized authority in the field of innate immunity
  • Dr. Golenbock is The Neil and Margery Blacklow Chair in Infectious Diseases and Immunology and Professor and Chief, Division of Infectious Diseases and Immunology at the UMass Chan Medical School

SECOND QUARTER FINANCIAL RESULTS

Since its inception in 2014 through June 30, 2023, ZyVersa has not generated any revenue and has incurred significant operating losses and negative cash flows from its operations. Based on our current operating plan, we expect our cash of $0.2 million as of June 30, 2023, will only be sufficient to fund our operating expenses and capital expenditure requirements on a month-to-month basis. ZyVersa will need additional financing to support its continuing operations. ZyVersa will seek to fund its operations through public or private equity or debt financings or other sources, which may include government grants and collaborations with third parties.

Research and development expenses were $1.2 million for the three months ended June 30, 2023, an increase of $0.5 million or 69.7% from the three months ended June 30, 2022. The increase is primarily attributable to an increase of $0.5 million in the costs of manufacturing of IC 100.

General and administrative expenses were $3.9 million for the three months ended June 30, 2023, an increase of $2.8 million or 237.5% from the three months ended June 30, 2022. The increase is primarily attributable to $1.2 million of common stock granted to certain stockholders in exchange for increasing the duration of their lockup period for certain common stockholdings, $0.5 million in professional fees associated with being a public company, a $0.5 million increase in marketing costs for investor and public relations, $0.4 million in director and officer insurance, and $0.2 million for bonus accruals.

Pre-tax losses were $86.3 million for the three months ended June 30, 2023, an increase of $84.3 million compared to a pre-tax loss of approximately $2.0 million, for the three months ended June 30, 2022. The higher net loss reported for the three months ended June 30, 2023 is primarily due to the impairment of in-process research and development and impairment of goodwill of $69.3 million and $11.9 million, respectively, compared to none for the three months ended June 30, 2022. The impairment is a result of the decline in ZyVersa’s market capitalization as of June 30, 2023.

Net losses were $78.5 million for the three months ended June 30, 2023, an increase of $76.5 million compared to a net loss of approximately $2.0 million for the three months ended June 30, 2022. A deferred tax benefit of $7.8 million for the three months ended June 30, 2023, compared to no tax benefit or expense during the three months ended June 30, 2022, resulted from the impairment of the in-process research and development.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq-GM: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 developed to ameliorate renal lipid accumulation that damages the kidneys’ filtration system in patients with glomerular kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s additional financing and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Media Contacts
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
Dschemelia@tiberend.com
609-468-9325

 
ZYVERSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
 
   Successor
   June 30, December 31,
   2023 2022
   (Unaudited)  
Assets   
      
Current Assets:   
 Cash$228,693  $5,902,199 
 Prepaid expenses and other current assets 886,911   225,347 
 Vendor deposits –   235,000 
  Total Current Assets 1,115,604   6,362,546 
Equipment, net 12,133   17,333 
In-process research and development 30,806,158   100,086,329 
Goodwill –   11,895,033 
Security deposit –   46,659 
Operating lease right-of-use asset 53,898   98,371 
      
  Total Assets$31,987,793  $118,506,271 
      
Liabilities, Temporary Equity and Stockholders’ Equity   
      
Current Liabilities:   
 Accounts payable$8,144,033  $6,025,645 
 Accrued expenses and other current liabilities 2,281,026   2,053,559 
 Operating lease liability 59,625   108,756 
  Total Current Liabilities 10,484,684   8,187,960 
Deferred tax liability 1,441,467   10,323,983 
  Total Liabilities 11,926,151   18,511,943 
      
Commitments and contingencies (Note 8)   
      
 Successor redeemable common stock, subject to possible redemption,   
 0 and 65,783 shares outstanding as of June 30, 2023 and   
 December 31, 2022, respectively –   331,331 
Stockholders’ Equity:   
 Successor preferred stock, $0.0001 par value, 1,000,000 shares authorized:   
 Series A preferred stock, 8,635 shares designated, 200 and 8,635 shares issued  
 and outstanding as of June 30, 2023 and December 31, 2022, respectively –   1 
 Series B preferred stock, 5,062 shares designated, 5,062 shares issued   
 and outstanding as of June 30, 2023 and December 31, 2022 1   1 
 Successor common stock, $0.0001 par value, 110,000,000 shares authorized;  
 23,669,074 and 9,016,139 shares issued at June 30, 2023 and December 31, 2022,  
 respectively, and 23,666,915 and 9,016,139 shares outstanding as of   
 June 30, 2023 and December 31, 2022, respectively 2,367   902 
 Additional paid-in-capital 107,044,663   104,583,271 
 Accumulated deficit (86,978,221)  (4,921,178)
 Treasury stock, at cost, 2,159 and 0 shares at June 30, 2023   
 and December 31, 2022, respectively (7,168)  – 
  Total Stockholders’ Equity 20,061,642   99,662,997 
      
  Total Liabilities, Temporary Equity and Stockholders’ Equity$31,987,793  $118,506,271 
      
 
ZYVERSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
     
            
   Successor  Predecessor Successor  Predecessor
   For the Three  For the Three For the Six  For the Six
   Months Ended  Months Ended Months Ended  Months Ended
   June 30,  June 30, June 30,  June 30,
   2023  2022 2023  2022
Operating Expenses:         
 Research and development$1,220,576   $719,395  $2,276,519   $1,786,357 
 General and administrative 3,929,225    1,164,013   7,465,362    3,465,382 
 Impairment of in-process research and development 69,280,171    –   69,280,171    – 
 Impairment of goodwill 11,895,033    –   11,895,033    – 
  Total Operating Expenses 86,325,005    1,883,408   90,917,085    5,251,739 
            
  Loss From Operations (86,325,005)   (1,883,408)  (90,917,085)   (5,251,739)
            
Other (Income) Expense:         
 Interest (income) expense 314    140,404   (765)   308,468 
 Change in fair value of derivative liabilities –    (19,600)  –    192,500 
            
  Pre-Tax Net Loss (86,325,319)   (2,004,212)  (90,916,320)   (5,752,707)
  Income tax benefit 7,812,226    –   8,859,277    – 
  Net Loss (78,513,093)   (2,004,212)  (82,057,043)   (5,752,707)
  Deemed dividend to preferred stockholders (7,915,836)   (331,200)  (7,915,836)   (331,200)
  Net Loss Attributable to Common Stockholders$(86,428,929)  $(2,335,412) $(89,972,879)  $(6,083,907)
            
            
  Net Loss Per Share         
  – Basic and Diluted$(4.84)  $(0.10) $(6.66)  $(0.25)
            
  Weighted Average Number of         
  Common Shares Outstanding         
  – Basic and Diluted 17,855,762    24,167,257   13,517,314    24,167,257 
            

Release – Ocugen Provides Business Update With Second Quarter 2023 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

August 21, 2023

PDF Version

Conference Call and Webcast Tomorrow at 8:30 a.m. ET

• Investigational New Drug (IND) Applications Cleared for Novel Gene Therapies for Geographic Atrophy Secondary to AMD and for Stargardt Disease

• OCU400 Clinical Study Results Update Expected This Quarter

MALVERN, Pa., Aug. 21, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today reported second quarter 2023 financial results along with a general business update.

“We continue to advance our pipeline to provide solutions for patients living with serious diseases but without effective treatment options,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “It remains our plan to start dosing patients across all of our ophthalmology programs by the end of the year and we are very enthusiastic about the FDA clearance of our INDs for OCU410 and OCU410ST for a form of Geographic Atrophy and Stargardt disease, respectively.”

During important meetings in the second quarter of 2023, including The Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting and BIO International, the Company continued to educate key stakeholders about the science behind its innovative modifier gene therapy platform and next-generation inhalation vaccine candidates aimed at enhancing durability and reducing transmission.

This quarter, Ocugen plans to share updated data results on OCU400 from its Phase 1/2 clinical trial in patients with retinitis pigmentosa. The Company also continues to have ongoing conversations with government agencies towards obtaining support of its inhaled vaccines for COVID-19 and flu.

“We remain dedicated to our mission to develop cutting-edge therapies with a commitment to ensuring global market access,” said Dr. Musunuri. “We are executing plans consistent with our long-term strategy of delivering multiple products to market targeting unmet medical needs utilizing first-in-class platform technologies in gene therapies, cell therapies and vaccines.”

Ophthalmic Gene Therapies

  • OCU400 – Phase 3 adult trial to be initiated near the end of 2023/early 2024, subject to the outcome of the ongoing Phase 1/2 trial and discussions with the FDA on the proposed Phase 3 trial plan.
  • OCU410 and OCU410ST – IND applications to initiate Phase 1/2 trials for both OCU410 and OCU410ST were cleared by the FDA and the Company plans to initiate Phase 1/2 trials by the end of 2023.

Regenerative Cell Therapies

  • NeoCart® – Manufacturing facility construction for NeoCart is on target to be completed by the end of 2023, as planned. The Company plans to initiate the Phase 3 trial in the second half of 2024.

Vaccines Portfolio

  • Inhaled Mucosal Vaccine Platform – The Company is continuing the internal development of its inhaled mucosal vaccine platform to achieve IND readiness and intends to submit an IND application in 2024, provided it receives government funding. The Company has submitted multiple proposals to obtain government funding and is continuing discussions with relevant government agencies regarding developmental support for its inhaled mucosal vaccine platform.

Second Quarter 2023 Financial Results

  • The Company’s cash, cash equivalents, and investments totaled $70.6 million as of June 30, 2023, compared to $90.9 million as of December 31, 2022. The Company had 256.5 million shares of common stock outstanding as of June 30, 2023.
  • Total operating expenses for the three months ended June 30, 2023 were $23.7 million and included research and development expenses of $14.2 million and general and administrative expenses of $9.6 million. Research and development expenses for the three months ended June 30, 2023 included a non-recurring, non-cash expense of $4.4 million as a result of the impairment of the short-term asset for the advanced payment for the supply of COVAXIN as well as the associated loss on the disposal of related fixed assets. This compares to total operating expenses for the three months ended June 30, 2022 of $19.6 million that included research and development expenses of $9.0 million and general and administrative expenses of $10.6 million.
  • Ocugen reported a $0.10 net loss per common share for the three months ended June 30, 2023 compared to a $0.09 net loss per common share for the three months ended June 30, 2022.

Conference Call and Webcast Details
Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET tomorrow to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

Attendees are invited to participate on the call or webcast using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 6803433
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

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

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements include, but are not limited to, statements regarding our clinical development activities and related anticipated timelines. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

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

(Tables to follow)

OCUGEN, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)
 
 June 30, 2023 December 31, 2022
Assets   
Current assets   
Cash and cash equivalents$70,578  $77,563 
Marketable securities —   13,371 
Prepaid expenses and other current assets 2,874   7,558 
Total current assets 73,452   98,492 
Property and equipment, net 11,720   6,053 
Other assets 3,804   4,087 
Total assets$88,976  $108,632 
Liabilities and stockholders’ equity   
Current liabilities   
Accounts payable$3,881  $8,062 
Accrued expenses and other current liabilities 7,787   9,900 
Operating lease obligations 526   498 
Current portion of long term debt 1,266   — 
Total current liabilities 13,460   18,460 
Non-current liabilities   
Operating lease obligations, less current portion 3,308   3,587 
Long term debt, net 1,472   2,289 
Other non-current liabilities 455   244 
Total liabilities 18,695   24,580 
Stockholders’ equity   
Convertible preferred stock 1   1 
Common stock 2,566   2,217 
Treasury stock (48)  (48)
Additional paid-in capital 320,181   294,874 
Accumulated other comprehensive income 22   26 
Accumulated deficit (252,441)  (213,018)
Total stockholders’ equity 70,281   84,052 
Total liabilities and stockholders’ equity$88,976  $108,632 
OCUGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
(Unaudited)
 
 Three months ended June 30, Six months ended June 30,
  2023   2022   2023   2022 
Operating expenses       
Research and development$14,169  $9,007  $23,727  $16,922 
General and administrative 9,564   10,558   17,757   20,677 
Total operating expenses 23,733   19,565   41,484   37,599 
Loss from operations (23,733)  (19,565)  (41,484)  (37,599)
Other income (expense), net 808   94   2,061   109 
Net loss$(22,925) $(19,471) $(39,423) $(37,490)
        
Shares used in calculating net loss per common share — basic and diluted 238,311,498   215,862,977   231,952,888   210,806,330 
Net loss per share of common stock — basic and diluted$(0.10) $(0.09) $(0.17) $(0.18)

Release – Bowlero Corp. Expands in Michigan

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BOWL

08/21/2023

Definitive agreements signed to acquire Merri-Bowl Lanes and BAM! Entertainment Center

RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corp. (NYSE: BOWL), the global leader in bowling entertainment, announced today they have entered into definitive agreements to acquire Merri-Bowl Lanes and BAM! Entertainment Center in Michigan. These acquisitions mark the company’s 4th and 5th locations in the state and are expected to close in the fall of 2023.

Located in Livonia, MI, Merri-Bowl Lanes is a traditional 35,000-square-foot center featuring 40 lanes of bowling. This location is a family-fun destination, showcasing a diverse array of entertainment experiences, including league play, youth and adult tournaments, parties, and events.

BAM! Entertainment Center, located in Holland, is a one-stop entertainment destination featuring 29 lanes of bowling and a multitude of dynamic offerings, including a laser tag arena, axe throwing, a high ropes course, and an expansive arcade. This entertainment center is also home to VIP party rooms, extensive menu options, and full-service bars.

“Our expansion in Michigan furthers our commitment to contributing a world-class experience across the country,” stated Thomas Shannon, Founder, President, and CEO of Bowlero Corp. “These acquisitions align with our ongoing strategic growth initiatives of buy, build and convert. We look forward to our continued growth as we welcome these additions to our portfolio.”

About Bowlero Corp

Bowlero Corp. is the global leader in bowling entertainment, media, and events. With more than 325 bowling centers across North America, Bowlero Corp. serves more than 30 million guests each year through a family of brands that includes Bowlero and AMF. In 2019, Bowlero Corp. acquired the Professional Bowlers Association, the major league of bowling, which boasts thousands of members and millions of fans across the globe. For more information on Bowlero Corp., please visit BowleroCorp.com

For Media:
PR@BowleroCorp.com

For Investors:
IRSupport@BowleroCorp.com

Source: Bowlero Corp

Release – Century Lithium Reports On Testing With Saltworks And Production Of Battery Grade Lithium Carbonate

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CYDVF

August 21, 2023 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (Century Lithium or the Company) is pleased to report testing results at Saltworks Technologies, Inc. (Saltworks) in Richmond, Canada, and additional production of high-purity lithium carbonate (Li2CO3) using product solutions from the Company’s Lithium Extraction Facility (Pilot Plant) in Amargosa Valley, Nevada, USA. The solutions tested at Saltworks were derived from leaching of claystone from the Company’s 100%-owned Clayton Valley Lithium Project (Project) in Nevada; and processed at the Pilot Plant via direct lithium extraction (DLE) to produce an intermediate concentrated lithium solution (DLE eluent).

“It is very positive to see consistency in our high-purity, 99.87%, lithium carbonate product grades from our Pilot Plant this year” stated Bill Willoughby, President, and CEO of Century Lithium. “The highlight though, is the almost five-fold increase in lithium grade in the concentrated lithium solution generated at the Pilot Plant. This was achieved through collaboration with Koch Technology Solutions and their Li-ProTM system, and its integration into Century Lithium’s chloride-based leaching process.”

Highlights

  • Repeated production of high-purity (99.87%) battery-grade lithium carbonate
  • Improved lithium concentrations in DLE eluent
  • Reduced volume of solution in downstream treatment and recycling
  • Potential to eliminate evaporation from the post DLE process flowsheet
  • Active testing underway to further improve DLE eluent grade

Lithium Carbonate Assay Results

Saltworks has once again produced battery-grade lithium carbonate (Li2CO3) from the DLE eluent produced at the Pilot Plant. The table below is a comparison of Saltworks’ 2023 results for Li2CO3, DLE eluent Batch 2, with the previously reported results from DLE eluent Batch 1 (see May 25, 2023 news release). Also shown are the constituent levels for battery grade Li2CO3, as published by two major producers. The assays results were finalized by Saltworks and independently assayed by SGS Canada, Inc. These results show consistency in composition of both the DLE eluent produced by the Pilot Plant earlier in the year and the resulting Li2CO3 product produced by Saltworks, achieving 99.871% content versus 99.875% reported previously.

Li2CO3 Assay Results
 Century Li2CO3
Batch 2 (August 2023)		Century Li2CO3
Batch 1 (May 2023)		Reference Grades
Li2CO3wt%99.87199.875>99.5
H2Owt%0.050.030.2 to <0.5
Nawt%0.0270.0470.03 to <0.05
Cawt%0.0120.0090.01 to <0.04
FeWppm33<5 to 10
AlWppm3<2<10 to 10
CuWppm3<4<5 to 10
NiWppm<5<5<6 to 10
ZnWppm<513<5 to 10
Clwt%0.010.008<0.01
Notes: wt% (weight percent), wppm (weight parts per million), calculated Li2CO3 purity based on sum of impurities measured above detection limit. Reference grades are from published specifications from two major producers of battery grade Li2CO3

Scroll right to view more 

Lithium in DLE Eluent

As recently reported (see August 9, 2023 news release), Century Lithium collaborated with Koch Technology Solutions (KTS), a Koch Engineered Solutions’ (KES) company, and integrated KTS’ Li-ProTM system into the DLE stage of the Pilot Plant. This work has increased the grades of the DLE eluent (intermediate lithium product solution) several fold. These changes are outlined in the table below, as reported by analyses from Saltworks.

DLE Eluate Assay Results    
Batch12345
Lithium (Li) (ppm)1,4301,6101,8853,9706,780
Sodium (Na) (ppm)22,40025,85024,15019,1008,220
Total dissolved solids (TDS) (ppm)77,45077,85082,60078,30079,300
Li:TDS0.0180.0210.0230.0510.085
Li:Na0.0640.0620.0780.2080.825
Notes: DLE eluent for Batch 1 and 2 used to produce Li2CO3cited above.

Scroll right to view more 

Batches 1, 2 and 3 are DLE eluents produced during the first quarter of 2023. Li2CO3 production was carried out to completion in batches 1 and 2 but the processing of Batch 3 was put on hold due to its similarity to batches 1 and 2 and the improvements seen in the grades of batches 4 and 5. These improvements in lithium grade from 1,430 parts per million (ppm) to 6,780 ppm, increase in the ratio of lithium to total dissolved solids (TDS) from 0.018 to 0.085, and reduction in sodium from 25,850 ppm to 8,220 ppm all occurred with the introduction of KTS’ Li-ProTM system into the DLE stage of the Company’s Pilot Plant.

Implications for Lithium Carbonate Production

The increase in lithium (Li) grade and the Li:TDS ratio has positive implications for the size and costs of the lithium carbonate production portion of the lithium extraction process at the Project. Within the Saltworks flowsheet, these higher values equate to a lower volume of solution to be treated and a proportionate decrease in the amount of water that must be removed (evaporated) prior to lithium carbonate precipitation. This will also affect the recycled solutions within the lithium carbonate production stage by reducing the volume of solutions moved in this stage and other leaching areas of the processing plant. 

The information derived from the Pilot Plant, including the test results from the combination of Century Lithium’s DLE process and KTS’ Li-ProTM system, and recent component changes at the Saltworks laboratory, is supplemental to the Feasibility Study for the project. The design basis for the Feasibility Study was established at a Li:TDS ratio of 0.02.

The Saltworks flowsheet targets a lithium grade of 10,000 to 20,000 ppm (10-20 g/L) for precipitation. Work with KTS at the DLE stage at the Pilot Plant has seen preliminary, internally assayed, lithium solution grades of over 8,000 ppm in the DLE eluent. Work is continuing within the DLE area to further increase lithium grades in solution, creating the scope to reduce solution volumes and the potential to eliminate a major evaporation step from the process flowsheet. As a supplement to the Feasibility Study, the Company is pursuing these potential cost and size savings with Saltworks.

Moving Forward

Work on the Feasibility Study continued throughout the six months ended June 30, 2023, with more than 20,000 consultant hours expended since its commencement. Following receipt of initial values from our consultants, Wood PLC and thyssenkrupp nucera, the Company is conducting internal reviews to assess optimization and cost reduction opportunities; work which is underway. In June 2023, the Company engaged Kiewit Industrial Group in Lone Tree, Colorado to assist with the review of project designs and estimates with attention to site development, material and supply costs, and construction methods. One optimization opportunity, reducing or eliminating the use of thickeners for tailings separation in the process configuration, was implemented and is under trial at the Pilot Plant.

The Company’s collaboration with KTS is underway, utilizing KTS’ Li-ProTM equipment in the DLE section of the Pilot Plant, where lithium is selectively recovered from the leach solution while deleterious elements are rejected. Testing with KTS is expected to continue through the 3rd quarter while KTS collects information to prepare an engineering design and cost estimate for a full-scale deployment of Li-ProTM system which will supplement the Company’s Feasibility Study.

Qualified Person

Todd Fayram, MMSA-QP and Daniel Kalmbach, CPG, are the qualified persons as defined by National Instrument 43-101 and have approved the technical information in this release.

About Century Lithium Corp.

Century Lithium Corp. (formerly Cypress Development Corp.) is an advanced stage lithium company, focused on developing its 100%-owned Clayton Valley Lithium Project in west-central Nevada, USA. Century Lithium is currently in the pilot stage of testing on material from its lithium-bearing claystone deposit at its Lithium Extraction Facility in Amargosa Valley, Nevada and progressing towards completing a Feasibility Study and permitting, with the goal of becoming a domestic producer of lithium for the growing electric vehicle and battery storage market.

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

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

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

Cautionary Note Regarding Forward-Looking Statements

This release includes certain statements that may be deemed to be “forward-looking statements”. Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “expects,” “estimates,” “projects,” “anticipates,” “believes,” “could,” “scheduled,” and other similar words. All statements in this release, other than statements of historical facts, that address events or developments that management of the Company expects, are forward-looking statements. Although management believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results or developments may differ materially from those in the forward-looking statements. The Company undertakes no obligation to update these forward-looking statements if management’s beliefs, estimates or opinions, or other factors, should change. Factors that could cause actual results to differ materially from those in forward-looking statements, include market prices, exploration, and development successes, continued availability of capital and financing, and general economic, market or business conditions. Please see the public filings of the Company at www.sedar.com for further information.

Release – Tonix Pharmaceuticals Announces Results of Pre-IND Meeting with FDA for TNX-801 as a Potential Vaccine to Prevent Mpox and Smallpox

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

August 21, 2023 7:00am EDTDownload as PDF

Phase 1/2 Clinical Trial of TNX-801 for the Prevention of Mpox and Smallpox to Commence Following Submission of an IND

TNX-801 is Based on a Proprietary Live Virus Vaccine Platform Designed to Stimulate Durable T-Cell Immunity

TNX-801 Vaccination Protected Animals from a Lethal Challenge with Monkeypox in Preclinical Testing

CHATHAM, N.J., Aug. 21, 2023 (GLOBE NEWSWIRE) —  Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it received the official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-8011 (recombinant horsepox virus, live vaccine) as a potential vaccine to protect against mpox disease (formerly known as monkeypox) and smallpox. Tonix believes the FDA feedback provides a path to agreement on the design of a Phase 1/2 study and the overall clinical development plan. The Phase 1/2 clinical trial will assess the safety, tolerability, and immunogenicity of TNX-801, following the submission and clearance of an IND.

“The FDA’s response to the pre-IND meeting marks an important milestone in the development of TNX-801 since we have FDA concurrence on the proposed manufacturing, toxicology studies, and the Phase 1/2 clinical design,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “TNX-801 is believed to be closely related to Edward Jenner’s original smallpox vaccine.2-10 Jenner’s live virus smallpox vaccine – the first vaccine – remains one of the most effective vaccines in history, since it typically provided lifetime immunity with a single dose, prevented forward transmission of the smallpox virus, and ultimately eradicated the disease. TNX-801 has an attenuated phenotype relative to modern vaccinia viruses, which comprise a group of vaccine viruses that evolved from Jenner’s vaccine during passage in man and animals for over 100 years. When live virus vaccinia vaccination was routinely practiced in Africa, mpox was kept out of the human population.”2,11

TNX-801 is a live replicating attenuated vaccine based on horsepox that is believed to protect against smallpox and mpox, primarily by eliciting a T-cell response evidenced by the “take”. The “take” is a functional measure of protective T-cell immunity validated by the eradication of smallpox. TNX-801 is administered with a single dose, can be readily scaled up for manufacturing using proven technology and can be distributed and stored without requiring a costly and cumbersome ultra-cold supply chain. Live replicating vaccines have the potential to induce durable T-cell immunity, prevent serious illness after infection and block forward transmission. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with mpox.12

“More than 30,000 people have contracted mpox in the U.S. so far during the 2022-23 epidemic,”13 said Dr. Zeil Rosenberg, Executive Vice President, Medical at Tonix. “The recent cluster of mpox in Chicago revealed breakthrough cases of mpox in individuals who had been vaccinated with the currently authorized non-replicating vaccine, which is administered in two doses.14 In contrast, TNX-801 is delivered intradermally with only one dose and therefore may achieve higher rates of community protection by eliminating drop-out between doses and limiting forward transmission. Moreover, relying on only one approved mpox vaccine at present is a risk for the global supply chain that has already led to insufficient availability of vaccine to meet global health needs, especially in Africa.”

Dr. Rosenberg added, “We believe TNX-801 could make a global impact on mpox and the risk of smallpox because of its potential durable T-cell immune response, the ability to manufacture at scale, to use a lower dose than non-replicating vaccines. The current formulation is a frozen liquid, but we believe that future lyophilized versions can be stored and shipped at standard refrigeration. Moreover, we believe the low dose of TNX-801 makes this technology amenable for future implementation in microneedle delivery systems.”

Dr. Lederman concluded, “In addition to its potential use as a vaccine, TNX-801 also has the potential as a viral vector platform, for which versions can be developed to protect against a host of infectious diseases beyond smallpox and mpox, including COVID-19. In light of the recent resurgence in COVID cases across the country with the new EG.5 “Eris” variant, we believe that the horsepox recombinant pox virus platform may provide next generation vaccines to prevent future outbreaks.”

About TNX-801*
TNX-801 is a live virus vaccine based on horsepox2,11. Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor. TNX-801 is believed to be more closely related to Jenner’s vaccinia vaccine than modern vaccinia vaccines, which appear to have evolved by deletions and mutations to a phenotype of larger plaque size in tissue culture and greater virulence in mice. Molecular analysis shows that horsepox is closer than modern vaccinia vaccines in DNA sequence to the vaccine discovered and disseminated by Dr. Edward Jenner.2-10 Vaccine genome researchers have recently shown the contemporaneous use of horsepox and horsepox-related viruses in the United States as smallpox vaccines in the 1860’s9,10. Additionally they found a remarkable degree of identity with the circa 1860 U.S. smallpox vaccine VK05 and the 1976 Mongolian horsepox isolate called MNR-76, upon which Tonix’s TNX-801 is based.3,5 These recent discoveries are further steps in establishing that what is called ’horsepox‘ today was used to vaccinate against smallpox in the 19th century. Dr. Edward Jenner invented vaccination in 1798 and the procedure was called “vaccination” because the inoculum material was initially obtained from lesions on the udders of cows affected by a mild disease known as cowpox2. ‘Cow’ is ‘vacca’ in Latin. However, Dr. Jenner suspected that cowpox originated from horsepox.2 Subsequently, Dr. Jenner and others immunized against smallpox using material directly obtained from horses. The use of vaccines from horses was sometimes called ‘equination’ from the Latin ‘equus’ which means ‘horse’. Equination and vaccination were practiced side-by-side in Europe6. The small plaque size in culture of TNX-801 appears identical to the U.S. Centers for Disease Control publication of the natural isolate12. Relative to vaccinia, horsepox has substantially decreased virulence in mice3. Tonix’s TNX-801 vaccine candidate is administered intradermally. The major cutaneous reaction or “take” to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization’s (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960’s.

  1. TNX-801 is in the pre-IND stage and has not been approved for any indication.
  2. Jenner E. “An Inquiry Into the Causes and Effects of the Variole Vaccinae, a Disease Discovered in Some of the Western Counties of England, Particularly Gloucestershire and Known by the Name of the cow‐pox.” London: Sampson Low, 1798.
  3. Noyce RS, et al. (2018) PLoS One. 13(1):e0188453
  4. Schrick L, et al. (2017) N Engl J Med 377:1491-1492
  5. Tulman ER, et al. (2006) J Virol. 80(18):9244-58.
  6. Esparza J, et al. (2017) Vaccine. 35(52):7222-7230.
  7. Esparza J, et al. (2020) Vaccine.  38(30):4773-4779.
  8. Qin L, et al. (2015) J Virol. 89(3):1809-24.
  9. Brinkmann A, et al, (2020) Genome Biology 21:286
  10. Duggan A, et al. (2020) Genome Biology 21:175 https://doi.org/10.1186/s13059-020-02079-z
  11. Noyce RS, et al., (2023) Viruses. 15(2):356.
  12. Trindade GS, et al. (2016) Viruses. 8(12):328.
  13. McQuiston JH, et al. (2023) The CDC Domestic Mpox Response — United States, 2022–2023. MMWR Morb Mortal Wkly Rep. 72(20):547–552
  14. Faherty EAG, et al.(2023) Emergence of an mpox cluster primarily affecting persons previously vaccinated against mpox-Chicago, Illinois, March 18-June 12, 2023. MMWR Morb Mortal Wkly Rep. , 72(25);696-698.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results are expected in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the µ-opioid receptor while maintaining activity in the rat Novel Object Recognition test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase 2 proof-of-concept study with topline data expected in the fourth quarter of 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

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

Tonix Medicines has contracted to acquire the Zembrace SymTouch and Tosymra registered trademarks. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc.

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

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

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

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

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Source: Tonix Pharmaceuticals Holding Corp.

Released August 21, 2023

Release – Ocugen To Host Conference Call on Tuesday, August 22 At 8:30 A.M. ET To Discuss Business Updates And Second Quarter 2023 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

August 18, 2023

PDF Version

MALVERN, Pa., Aug. 18, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that it will host a conference call and live webcast to discuss the Company’s second quarter 2023 financial results and provide a business update at 8:30 a.m. ET on Tuesday, August 22, 2023.

Ocugen will issue its 2Q23 financial results on Monday, August 21, 2023. Following the press release, the Company will hold the conference call on Tuesday, August 22 at 8:30 a.m. ET. Attendees are invited to participate in the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 6803433
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

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

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

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

Release – Baudax Bio Announces $1.9 Million Registered Direct Offering Priced At-The-Market under Nasdaq Rules

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BXRX

August 17, 2023 8:00am EDT

MALVERN, Pa., Aug. 17, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (Nasdaq: BXRX), a biotechnology company focused on developing T cell receptor therapies utilizing human regulatory T cells, as well as a portfolio of clinical stage Neuromuscular Blocking Agents and an associated reversal agent, today announced that it has entered into definitive agreements for the purchase and sale of 2,006,544 shares of its common stock and 1,395,243 Series E pre-funded warrants at a purchase price of $0.56 per share of common stock (or $0.55 per prefunded warrant) in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered series A-7 common stock purchase warrants (the “warrants”) to purchase up to 3,401,787 shares of common stock. The warrants have an initial exercise price of $0.56 per share and are not exercisable until the shareholders of the Company approve the issuance of the underlying shares (the “Approval”). The warrants are exercisable for a period of five years commencing from the date the Approval is obtained. Additionally, the exercise price of the warrants will be adjusted upon the Company effecting a reverse stock split, if the post-reverse stock split exercise price of the warrants is higher than the lowest daily VWAP of the common stock during the five trading days following the reverse stock split (the “Adjustment”). If the Adjustment is applicable, the exercise price of the warrants will be reduced to the lowest daily VWAP of the common stock during the five trading days following such reverse stock split, and the number of shares issuable upon exercise of the warrants shall increase such that the aggregate exercise price payable as a result of such Adjustment shall be equal to the aggregate exercise price payable prior to such Adjustment. The closing of the registered direct offering and the concurrent private placement is expected to occur on or about August 21, 2023, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offerings, before deducting offering expenses payable by the Company, are expected to be approximately $1.9 million. The Company intends to use the net proceeds from the offerings for pipeline development activities and general corporate purposes.

The shares of common stock, the prefunded warrants and the shares of common stock underlying the prefunded warrants described above (but not the series A-7 warrants issued in the concurrent private placement or the shares of common stock underlying such warrants) are being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-253117) previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on September 2, 2021. The offering in the registered direct offering of the shares of common stock, prefunded warrants and the shares of common stock issuable thereunder is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus, when available, may be obtained on the SEC’s website at http://www.sec.gov.

The warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

In addition, on August 16, 2023, the Company also amended its series A-5 warrants to purchase 3,478,262 shares of the Company’s common stock (the “Series A-5 Warrants”) and series A-6 warrants to purchase 3,478,262 shares of the Company’s common stock (the “Series A-6 Warrants” and, collectively, the “Amended Warrants”) to (i) adjust the exercise price per share of common stock of the Amended Warrants to $0.56 per share of common stock, (ii) extend the expiration date of the Series A-5 Warrants to August 21, 2028 and (iii) extend the expiration date of the Series A-6 Warrants to February 21, 2025.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Baudax Bio

Baudax Bio is a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent. Our TCR Treg programs primarily focus on immune modulating therapies for orphan diseases or complications associated with such diseases, as well as the treatment of autoimmune disorders. We believe that our TCR Treg programs have the potential to provide valuable therapeutic options to patients suffering from diseases for which there are limited treatment options and significant unmet need, as well as to prescribers and payers in these markets.

Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend” and “expect” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. Forward-looking statements may include, without limitation, statements regarding market conditions, the closing of the offerings, the satisfaction of the closing conditions of the offerings, the approval of the warrants by the Company’s stockholders, and the use of net proceeds from the offerings. These forward-looking statements are based on information available to Baudax Bio as of the date of publication of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, whether Baudax Bio will be able to successfully integrate the TeraImmune operations; whether Baudax’s shareholders will approve the conversion of the Series X Non-Voting Convertible Preferred Stock; whether Baudax Bio’s cash resources will be sufficient to fund its continuing operations and the newly acquired TeraImmune operations, including the liabilities of TeraImmune incurred in connection with the completion of the transactions; risks related to market, economic and other conditions, Baudax Bio’s ability to advance its product candidate pipeline through pre-clinical studies and clinical trials, that interim results may not be indicative of final results in clinical trials, that earlier-stage trials may not be indicative of later-stage trials, the approvability of product candidates, Baudax Bio’s ability to raise future financing for continued development of its product candidates, Baudax Bio’s ability to pay its debt and to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; Baudax Bio’s ability to maintain listing on the Nasdaq Capital Market; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

Investor Relations Contact:

Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

Source: Baudax Bio

Released August 17, 2023

Release – Entravision Announces Extension Of NFL Partnership For Exclusive National Spanish Radio Broadcast Rights For 9th Consecutive Season

Posted on by aweinsoff@channelchek.com

Research News and Market Data on EVC

08/17/2023

SANTA MONICA, Calif.–(BUSINESS WIRE)– Entravision Communications Corporation (NYSE: EVC), a leading global media and marketing technology company, today announced that the Company will bring listeners the most extensive Spanish language radio broadcast coverage of the NFL for the 2023-24 season. For the 9th consecutive season, Entravision will broadcast 51 prime NFL games in Spanish across its US owned-and-operated radio stations and in key markets through affiliate partnerships that include Latino Media Network.

Entravision will begin with the NFL Kickoff game on Thursday, September 7th, featuring a match-up between the Detroit Lions and the defending Super Bowl champions, the Kansas City Chiefs. Radio coverage continues across the expanded 18-week NFL season, including all Sunday Night Football and Monday Night Football games, and will continue through the postseason, including the AFC Championship, NFC Championship, and, for the very first time, culminating with Super Bowl LVIII in Las Vegas on February 11, 2024. Super Bowl LVIII will be played at Allegiant Stadium, home of the NFL’s Las Vegas Raiders.

Entravision’s game day broadcasts include a pre-game show, followed by the live game broadcast and post-game analysis. In addition, Sunday broadcasts start with a 30-minute signature analysis show, Pase Completo, prior to the pre-game show, featuring veteran multi-sport announcer Ricardo Celis and game analyst Tony Nuñez. The Pase Completo program will also be streamed live on Facebook Live.

“We are thrilled to extend our long-term partnership with the NFL and bring our listeners the most extensive Spanish language radio broadcast of the National Football League,” said Jeffery Liberman, President and Chief Operating Officer of Entravision Communications Corporation. “The fastest-growing fan base for the NFL is the Latino consumer which is passionately awaiting the start of the season. We have had a great partnership with the NFL, and we will continue to build upon this momentum to provide best-in-class coverage and unique cross-promotions that amplify key NFL initiatives.”

“Our partnership with Entravision is vital, as it helps bring the NFL to Spanish-speaking fans across the country, one of the fastest growing segments of our football fan base,” said Marissa Solis, NFL SVP Global Brand and Consumer Marketing. “Providing Spanish language calls of a large slate of NFL games, including Sunday Night and Monday Night Football, as well as the postseason and the Super Bowl, Entravision will ensure that our Latino fans have the access to the NFL that they deserve.”

 
Entravision O&O Station List
   
MarketStationCall Letters
 
Los Angeles, CAViva 103.1 FMKDLD-FM/KDLE-FM
 
Phoenix, AZLa Suavecita 106.9 y 107.1 FMKVVA-FM and KDVA-FM
 
Denver, COLa Suavecita 92.1 FMKJMN-FM
 
Sacramento, CALa Suavecita 104.3 FMKXSE-FM
 
Las Vegas, NVFuego 92.7 FMKRRN-FM
 
El Paso, TXLa Suavecita 93.9 FMKINT-FM
 
Monterey/Salinas, CALa Suavecita 107.1 FMKSES-FM
 
Albuquerque, NMTUDN 1450 AMKRZY-AM
 
McAllen, TXLa Suavecita 101.9 FMKNVO-FM
 
Palm Springs, CAFuego 103.5 FMKPST-FM
 
Stockton/ModestoLa Suavecita 97.1 FMKTSE-FM
 
Reno, NVLa Tricolor 102.1 FMKRNV-FM
 
El Centro, CALa Suavecita 94.5 FMKSEH-FM
 
Lubbock, TXTUDN 1460 AMKBZO-AM
 
Aspen, COLa Tricolor 104.3 y 107.1 FMKPVW-FM
 
Latino Media Network Affiliate Station List
 
MarketStationCall Letters
 
New York, NY1280 AMWADO-AM*
 
Miami, FL1140 AMWQBA-AM
 
Chicago, IL1200 AMWRTO-AM
 
Dallas, TX1270 AMKFLC-AM
 
*WADO-AM is under contract to be acquired by Latino Media Network from TelevisaUnivision.
 

About Entravision Communications Corporation

Entravision is a diversified global media, marketing and technology company serving clients throughout the United States and in more than 20 countries across Latin America, Europe, and Asia. Entravision has 54 television stations and is the largest affiliate group of the Univision and UniMás television networks, and 48 Spanish-language radio stations that feature nationally recognized, award-winning talent. Our dynamic digital portfolio includes Entravision Digital, which serves SMBs in high-density U.S. Latino markets and provides cutting-edge mobile programmatic solutions and demand-side platforms that allow advertisers to execute performance campaigns using machine-learned bidding algorithms, along with Cisneros Interactive, a leader in digital advertising solutions in the Latin American and U.S. Hispanic markets representing major technology platforms. Shares of Entravision Class A Common Stock trade on The New York Stock Exchange under the ticker symbol: EVC. Learn more about all of our media, marketing and technology offerings at entravision.com or connect with us on LinkedIn and Facebook.

About Latino Media Network

Latino Media Network is a media company serving the Latino community by helping us make sense of the world and their place in it. We will inspire, inform and celebrate Latinos through an audio focused multimedia network, owned and operated by members of our community. We will focus on content creation across a variety of culturally relevant subjects and help our community navigate the ocean of information that exists in our society. The network will create cultural pride by telling our stories, addressing our concerns and talking about opportunities for a better future.

Contact for Affiliation:
Andrea Prado, abecerra@entravision.com
(323) 900-6302

Contact for Advertising:
Lilliana Aristizabal, laristizabal@entravision.com
(212) 697-2513

Contact for Marketing Partnerships:
Karina Cerda, kcerda@entravision.com
(323) 900-6112

Contact for Entravision:
Kimberly Orlando, Managing Director
ADDO Investor Relations
evc@addo.com
korlando@addo.com

Source: Entravision Communications Corporation