Author: [email protected]

Release – Travelzoo Q2 2023 Earnings Conference Call on July 27 at 11:00 AM ET

Posted on by [email protected]

Research News and Market Data on TZOO

07/21/2023

NEW YORK, July 21, 2023 /PRNewswire/ — Travelzoo® (NASDAQ: TZOO):

WHAT:Travelzoo, a global Internet media company that provides exclusive offers and experiences for members, will host a conference call to discuss the Company’s financial results for the second quarter ended June 30, 2023. Travelzoo will issue a press release reporting its results before the market opens on July 27, 2023.
WHEN:July 27, 2023 at 11:00 AM ET
HOW:A live webcast of Travelzoo’s Q2 2023 earnings conference call can be accessed athttp://ir.travelzoo.com/events-presentations. The webcast will be archived within 2 hours of the end of the call and will be available through the same link.
CONTACT:Travelzoo Investor Relations
[email protected]

About Travelzoo

Travelzoo® provides its 30 million members with exclusive offers and one-of-a-kind experiences personally reviewed by our deal experts around the globe. We have our finger on the pulse of outstanding travel, entertainment, and lifestyle experiences. We work in partnership with more than 5,000 top travel suppliers—our long-standing relationships give Travelzoo members access to irresistible deals.

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SOURCE Travelzoo

Release – GeoVax Announces Initiation of Phase 2 Clinical Trial of COVID-19 Vaccine Booster in Patients with Chronic Lymphocytic Leukemia

Posted on by [email protected]

Research news and Market Data on GOVX

 

  • Last updated: 20 July 2023 13:05
  • Created: 20 July 2023 17:39
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Seeking Improved Immune Response vs mRNA Vaccine

ATLANTA, GA, July 20, 2023 — GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the start of an investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355), titled “Randomized observer-blinded phase 2 trial of COVID-19 booster with GEO-CM04S1 or Pfizer-BioNTech Bivalent vaccine in patients with chronic lymphocytic leukemia,” at City of Hope National Medical Center, led by Alexey Danilov, M.D., PhD as principal investigator. GEO-CM04S1, a multi-antigenic SARS-CoV-2 vaccine that targets the spike (S) and nucleocapsid (N) proteins of SARS-CoV-2, is actively under clinical study by GeoVax in severely immunocompromised individuals, as well as in healthy adults for use as a universal heterologous booster.

Despite a high vaccination rate, chronic lymphocytic leukemia (CLL) patients may be at high risk for lethal COVID-19 infection due to poor immune response to COVID-19 infections or vaccination. The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone that may be more effective at inducing COVID-19 immunity in patients with poor humoral immune responses since MVA strongly induces T cell expansion even in the background of immunosuppression. Targeting both the spike and nucleocapsid protein antigens broaden the specificity of the immune responses and protects against the loss of efficacy associated with the significant sequence variation observed with the spike antigen.

The study will examine the use of two injections of GEO-CM04S1 three months apart to assess immune responses in these vulnerable patients, with the Pfizer-BioNTech Bivalent vaccine as the control arm. Participants will be randomized 1:1 to receive two boosters with either the GEO-CM04S1 or the control vaccine. The primary immune response outcome will be 56 days following the first booster injection. Up to 40 participants will be treated in each arm, with immune responses evaluated at the interim and final analyses in each arm.

Brian Koffman, M.D.C.M., FCFP DABFP (retired) MS Ed, Executive Vice President and Chief Medical Officer of the CLL Society, a nonprofit dedicated to the unmet needs of those diagnosed with CLL/small lymphocytic lymphoma (SLL), commented, “Despite the current authorized COVID-19 vaccines providing protective immunity among the majority of patient populations, individuals with CLL/SLL, regardless of their treatment status, have had less predictable and often insufficient immune responses to the currently authorized vaccines. Within the CLL/SLL patient population, more robust and durable protective immunity is needed, especially next-generation vaccines that could induce stronger T cell and antibody responses. This trial leverages past success with a similar type of vaccine used for protection against a different viral infection in the immunocompromised to develop a vaccine intended to provide enhanced and more durable protection against COVID-19 infections in the high-risk CLL/SLL population. The CLL Society and the CLL/SLL community welcome this study and look forward to the results.”

Kelly McKee, M.D., GeoVax Chief Medical Officer, commented, “Unpublished clinical data recently presented at several medical conferences confirmed our earlier findings in healthy adults that GEO-CM04S1 stimulated a robust, durable, and broad-based humoral and cellular immune response against multiple SARS-CoV-2 variants, and by extension, to immunocompromised patients. Validation of these findings in additional patients with hematologic malignancies, who have received CAR-T and stem cell transplants, is underway as we seek to provide a vaccine solution to those individuals unable to mount adequate protective responses with currently available COVID-19 vaccines. We expect the CLL trial will further confirm the potential benefit of CM04S1 in another population of immunocompromised individuals.”

David Dodd, GeoVax President, and CEO, added, “We are excited to begin this third important study for CM04S1 and look forward to sharing progress reports as we advance. We believe the CM04S1 vaccine, containing the two antigens, S and N, along with the recognized antibody and cellular immune responses resulting from the MVA approach, has the potential to offer greater booster protection than that from the current vaccines in use, as well as provide a greater degree of protection within immunocompromised patients.”

About GEO-CM04S1

GEO-CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. CM04S1 presents both the spike and nucleocapsid antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to non-variable parts of the virus. The more broadly specific and functional engagement of the immune system is designed to protect against the new and continually emerging variants of COVID-19. Based on data from animal models and a completed Phase 1 clinical study, vaccine-induced immune responses were shown to recognize both early and later variants of SARS-CoV-2, including the Omicron variant. Vaccines of this format should not require repeated modification and updating.

A recent presentation of unpublished data from the open-label portion of the Phase 2 trial of CM04S1 (ClinicalTrials.gov Identifier: NCT04977024) in patients undergoing hematological cancer treatment (i.e., patients who have reduced immune system function as a result of treatment) indicates that CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses. These data support the planned progression of the Phase 2 clinical study, which will include a direct comparison to currently approved mRNA vaccines. CM04S1 also continues to advance in another Phase 2 clinical trial as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466). Data from these studies will form the basis for comparing vaccine potential in unique patient groups as well as the general population.

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 two Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a COVID-19 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. In addition, GEO-CM04S1 is in 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. 

Investor Relations Contact:

Rich Cockrell

CG Capital

404-736-3838

[email protected]

Media Contact:

Susan Roberts

[email protected]

202-779-0929

Release – Kelly Announces Strategic Restructuring Actions to Accelerate Profitable Growth

Posted on by [email protected]

Research News and Market Data on KELYA

July 20, 2023

  • Strategic restructuring follows comprehensive review of company’s growth and efficiency objectives as part of ongoing transformation
  • Aggressive action builds on strategic progress to monetize non-core assets, reinvest capital in organic and inorganic growth initiatives, and shift to higher-margin, higher-growth business mix
  • Actions expected to result in meaningful, sustainable EBITDA margin expansion beginning immediately, and substantial improvement in the second half of 2023 and beyond

TROY, Mich., July 20, 2023 /PRNewswire/ — Kelly (Nasdaq: KELYA, KELYB), a leading global specialty talent solutions provider, today announced strategic restructuring actions that will further optimize the company’s operating model to enhance organizational efficiency and effectiveness. These actions are part of the comprehensive transformation initiative the company announced in May to drive EBITDA margin improvement and accelerate long-term profitable growth.

The strategic restructuring actions realign business-critical resources to Kelly’s business units, streamline corporate resources, reduce redundant organizational layers, and optimize work processes. These structural changes simplify the company’s operations and unlock additional resources to invest in growth. As a result of these actions, the company has implemented a workforce reduction plan and notified affected employees in accordance with applicable employment laws and regulations. Employees whose roles were included in the workforce reduction are eligible for applicable severance, benefits, and outplacement services.

“Today marks a difficult but necessary step forward on Kelly’s journey to accelerate profitable growth,” said Peter Quigley, president and chief executive officer. “These actions follow an exhaustive review of the company’s business and functional operations to determine how we can work more efficiently to improve profitability over the long term. I am confident the structural improvements we have made to Kelly’s operating model position the company to pursue new avenues of growth that will enable it to deliver greater value for customers, talent, and shareholders.”

As a result of the strategic restructuring actions, Kelly expects to see meaningful expansion of its EBITDA margin beginning immediately with substantial improvement in the second half of 2023 and beyond. The company expects to incur a restructuring charge from these actions in the range of $7.5-$8.5 million in the third quarter of 2023. Mr. Quigley and Olivier Thirot, executive vice president and chief financial officer, will provide additional details about the strategic restructuring as it relates to the company’s ongoing transformation, including expectations for EBITDA margin improvement, during its upcoming second-quarter earnings conference call on August 10, 2023.

About Kelly®

Kelly Services, Inc. (Nasdaq: KELYA, KELYB) helps companies recruit and manage skilled workers and helps job seekers find great work. Since inventing the staffing industry in 1946, we have become experts in the many industries and local and global markets we serve. With a network of suppliers and partners around the world, we connect more than 450,000 people with work every year. Our suite of outsourcing and consulting services ensures companies have the people they need, when and where they are needed most. Headquartered in Troy, Michigan, we empower businesses and individuals to access limitless opportunities in industries such as science, engineering, technology, education, manufacturing, retail, finance, and energy. Revenue in 2022 was $5.0 billion. Learn more at kellyservices.com.

Forward-Looking Statements

This release contains statements that are forward looking in nature and, accordingly, are subject to risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about Kelly’s financial expectations, are forward-looking statements. Factors that could cause actual results to differ materially from those contained in this release include, but are not limited to, (i) changing market and economic conditions, (ii) disruption in the labor market and weakened demand for human capital resulting from technological advances, loss of large corporate customers and government contractor requirements, (iii) the impact of laws and regulations (including federal, state and international tax laws), (iv) unexpected changes in claim trends on workers’ compensation, unemployment, disability and medical benefit plans, (v) litigation and other legal liabilities (including tax liabilities) in excess of our estimates, (vi) our ability to achieve our business’s anticipated growth strategies, (vi) our future business development, results of operations and financial condition, (vii) damage to our brands, (viii) dependency on third parties for the execution of critical functions, (ix) conducting business in foreign countries, including foreign currency fluctuations, (x) availability of temporary workers with appropriate skills required by customers, (xi) cyberattacks or other breaches of network or information technology security, and (xii) other risks, uncertainties and factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. In some cases, forward-looking statements can be identified by words or phrases such as “may,” “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. All information provided in this press release is as of the date of this press release and we undertake no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company’s expectations.

KLYA-FIN

MEDIA CONTACT:ANALYST CONTACT:
Jane StehneyJames Polehna
(248) 765-6864(248) 244-4586
[email protected][email protected]

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SOURCE Kelly Services, Inc.

Release – Travelzoo is the Top Choice for Travel Enthusiasts in Germany

Posted on by [email protected]

Research News and Market Data on TZOO

07/20/2023

BERLIN, July 20, 2023 /PRNewswire/ — Travelzoo® (NASDAQ: TZOO), a global Internet media company that provides exclusive offers and experiences for members, has won the top spot in the category of “Best Travel Deals Provider” in a nationwide consumer survey in Germany. The win has particular significance given Germany is the third-largest travel market in the world.

The survey was conducted by renowned research institute ServiceValue GmbH in partnership with Die Welt, one of the country’s most influential national newspapers.

Casting over 900,000 votes, consumers ranked 2,513 companies across 187 categories, making this one of the most comprehensive consumer-voted surveys in Germany. When asked which brand exhibits the highest quality for travel deals, consumers cast the largest number of votes for Travelzoo, naming it “Product Champion”.  

Winners in other categories included companies such as Mercedes-Benz, Lufthansa, Rolex, and Amazon.

Travelzoo was also recognized for “high customer value” in a second national survey this month, commissioned by popular broadsheet BILD Zeitung. Consumers cast over 500,000 votes, evaluating 2,198 companies in 138 categories.

Find out why Travelzoo is the choice of judges, industry experts, and more than 30 million members around the world. Become a Travelzoo member today: https://travelzoo.com/signup.

About Travelzoo

Travelzoo® provides its 30 million members with exclusive offers and one-of-a-kind experiences personally reviewed by our deal experts around the globe. We have our finger on the pulse of outstanding travel, entertainment, and lifestyle experiences. We work in partnership with more than 5,000 top travel suppliers—our long-standing relationships give Travelzoo members access to irresistible deals.

Travelzoo is a registered trademark of Travelzoo. All other names are trademarks and/or registered trademarks of their respective owners.

Media Contacts:    

Regina Schneider – Berlin
+49 160 7498 691
[email protected]

Cat Jordan – London
+44 77 7678 1525
[email protected]

Paige Cram – Los Angeles
+1 609 668 0645
[email protected]

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Release – Largo Reports Improvements to Production in Q2 2023 and Begins Commissioning of its Ilmenite Concentration Plant; Francesco D’Alessio Appointed as President of Largo Clean Energy

Posted on by [email protected]

Research News and Market Data on LGO

July 19, 2023

Q2 2023 and Other Highlights

  • V2O5 production of 2,639 tonnes (5.8 million lbs1) in Q2 2023 vs. 3,084 tonnes produced in Q2 2022 and 25% above production in Q1 2023
  • V2O5 production of 676 tonnes in April, 945 tonnes in May and 1,018 tonnes in June
  • The Company achieved normalized production levels in June after completing the following actions in Q2 2023: the completion of its infill drilling campaign for 2023 resulting in a further refinement of the Company’s short-term mining model, the completion of upgrades to its crushing process as well as an improvement in its mining performance over levels seen in Q1 2023
  • The Company completed all planned upgrades to its crushing process in Q2 2023, including the installation of a new dry magnetic separator and updates to its crushing circuit, which is expected to reduce operational maintenance costs and provide more flexibility in the blending of different ores to stabilize V2O5 production going forward
  • Global V2O5 recovery rate3 of 81.0% in Q2 2023 vs. 81.8% in Q2 2022
  • The Company completed construction of its ilmenite concentration plant in June and subsequently began commissioning of the facility shortly thereafter; The Company expects to complete the commissioning phase in Q3 2023 and start a gradual ramp-up of ilmenite production in Q4 2023
  • V2O5 equivalent sales of 2,557 tonnes in Q2 2023 vs. 3,291 tonnes sold in Q2 2022 due to lower available inventory
  • During Q2 2023, the average benchmark price per lb of V2O5 in Europe was $8.46, a 24% decrease from the average of $11.08 seen in Q2 2022 following softer spot market demand during the quarter, primarily due to adverse conditions in the Chinese and European steel sectors
  • Francesco D’Alessio was appointed as President of Largo Clean Energy (“LCE”)
  • Cold commissioning of LCE’s Enel Green Power España (“EGPE”) vanadium redox flow battery (“VRFB”) was completed in Q2 2023; Hot commissioning and provisional acceptance by EGPE is expected in Q3 2023
  • 2023 production, sales, cost and capital expenditures guidance remain unchanged

TORONTO–(BUSINESS WIRE)– Largo Inc. (“Largo” or the “Company“) (TSX: LGO) (NASDAQ: LGO) today announces quarterly production of 2,639 tonnes (5.8 million lbs1) and sales of 2,557 tonnes of vanadium pentoxide (“V2O5”) equivalent, respectively, in Q2 2023.

Daniel Tellechea, Interim CEO and Director of Largo, stated: “We are pleased to report that key operational actions taken in Q2 2023 have resulted in improved production rates exiting the quarter, particularly in June with over 1,000 tonnes of V2O5 produced. He continued: “In Q2 2023, construction of the Company’s ilmenite concentration plant was completed, followed by the start of commissioning, marking a significant milestone for the Company. As we look forward to completing commissioning and ramp-up processes in the following quarters, we anticipate having sufficient stocks of produced ilmenite concentrate for sale by the start of 2024.”

Francesco D‘Alessio, President of LCE commented: “With this new role, I am fully committed to leading LCE with the immediate objective of evaluating all strategic options for this business in order to fully maximize its unique value proposition in the energy storage sector. This includes but is not limited to the potential strengthening and formalization of existing industry relationships, developing additional collaborative partnerships, evaluating alternative deployment strategies, and performing a comprehensive review of cost reduction measures. Going forward, I anticipate providing updates as this process continues to evolve.”

Maracás Menchen Mine Operational and Sales Results

Q2 2023Q1 2023Q2 2022
    
Total Ore Mined (tonnes)489,892341,967378,273
Ore Grade Mined – Effective Grade (%) 20.860.811.18
Total Mined – Dry Basis (tonnes)3,671,8423,523,6562,503,696
    
Concentrate Produced (tonnes)99,08378,695124,317
Grade of Concentrate (%)3.342.993.28
Global Recovery (%) 381.083.081.8
    
V2O5 produced (Flake + Powder) (tonnes)2,6392,1113,084
High purity V2O5 equivalent produced (%)35.847.818.7
V2O5 produced (equivalent pounds) 15,817,9924,653,9536,799,048
Total V2O5 equivalent sold (tonnes)2,5572,8493,291
Produced V2O5 equivalent sold (tonnes)2,2682,6042,783
Purchased V2O5 equivalent sold (tonnes)289245508
      

Q2 2023 Additional Highlights

  • Normalized Production Levels in June: V2O5 production from the Maracás Menchen Mine was 676 tonnes in April, 945 tonnes in May and 1,018 tonnes in June for a total of 2,639 tonnes produced in Q2 2023. In addition to certain mining performance and crushing process improvements made during the quarter, the Company also completed its 2023 infill drilling campaign in Q2 2023, resulting in a further refinement of the Company’s short-term mining model. In Q2 2023, global recoveries3 averaged 81.0%, largely in line with 81.8% averaged in Q2 2022. The Company mined 489,892 tonnes of ore with an effective V2O5 grade2 of 0.86% in Q2 2023 compared to 378,273 tonnes with an effective V2O5 grade2 of 1.18% in Q2 2022 and 341,967 tonnes with an effective V2O5 grade2 of 0.81% in Q1 2023, demonstrating a significant improvement in total ore mined over the prior quarter and prior comparative quarter. The increase in total ore mined as well as increased crushed and milled ore is a direct result of the Company’s strategy to successfully recover delays caused by the previously announced mine contractor transition in September 2022 and heavy rains experienced in December 2022.

  • Mine Site Cost Reduction Measures: The Company continues to focus on identifying and implementing various cost reduction measures at its Maracás Menchen Mine during the current period of sustained inflationary pressures. In addition to upgrading its crushing process to reduce operational maintenance costs, the Company has identified several other areas for cost reduction and is in the process of implementing the following initiatives: a reduction in sodium carbonate and other raw materials expenditures, a reduction of mining costs, with a primary focus on reducing rehandling activities and implementing an optimization of haulage distance and a reduction of equipment rental expenditures. The Company expects to begin realizing the benefits of these cost reduction measures in Q3 2023.

  • 2023 and 2024 Infill Drilling Campaigns: The Company has completed its 2023 infill drilling campaign and has completed approximately 90% of its 2024 infill drilling campaign. Data generated from infill drilling is expected to create greater accuracy and reliability of the short-and mid-term mining plan for the Maracás Menchen Mine. Going forward, the Company plans to conduct infill drilling on a bi-annual basis to create greater certainty and efficiency in its planning process. Largo expects that a consistent infill drilling campaign should assist the Company in improving the reliability and accuracy of its production guidance on a go forward basis.

  • Q2 2023 Sales In Line with Quarterly Target – Focus on High Purity Vanadium Demand: In Q2 2023, V2O5 equivalent sales of 2,557 tonnes (which includes 289 tonnes of purchase material sold) were in line with expectations for the quarter but represented a 22% decrease in tonnes sold over Q2 2022. In Q2 2023, the Company continued to experience strong aerospace demand for its products and focused on selling its high purity vanadium units to this market. The Company produced approximately 36% of its quarterly production as high purity in Q2 2023.

  • Cold Commissioning of Enel Green Power España VRFB Completed: During Q2 2023, LCE finalized the pumping of electrolyte for EGPE’s VCHARGE VRFB deployment and completed cold commissioning of the system in June. The battery system was also successfully interconnected with the grid and the system inverter was successfully utilized to form the chemistry in Q2 2023. The battery is currently performing charge-discharge cycles as part of the ongoing hot commissioning phase, which is anticipated to be completed in Q3 2023, along with provisional acceptance of the system by EGPE.

  • Appointment of Francesco D’Alessio as President of LCE: Mr. D’Alessio has over 15 years of experience in metals sales and trading, including overseeing sales and shipment of vanadium, as well as more recent experience in clean energy storage sales. Over the last three years, he has been actively involved in the overall sales strategy at Largo, contributing to the Company’s ongoing initiatives in the energy storage sector. Mr. D’Alessio began his tenure at Largo in 2019 as Head of Sales, Americas, and was subsequently promoted to the position of Commercial Director in 2022.

About Largo

Largo has a long and successful history as one of the world’s preferred vanadium companies through the supply of its VPURETM and VPURE+TM products, which are sourced from one of the world’s highest-grade vanadium deposits at the Company’s Maracás Menchen Mine in Brazil. Aiming to enhance value creation at Largo, the Company is in the process of implementing a ilmenite concentrate plant using feedstock sourced from its existing operations in addition to advancing its U.S.-based clean energy division with its VCHARGE vanadium batteries. Largo’s VCHARGE vanadium batteries contain a variety of innovations, enabling an efficient, safe and ESG-aligned long duration solution that is fully recyclable at the end of its 25+ year lifespan. Producing some of the world’s highest quality vanadium, Largo’s strategic business plan is based on two pillars: 1.) leading vanadium supplier with an outlined growth plan and 2.) U.S.-based energy storage business to support a low carbon future.

Largo’s common shares trade on the Nasdaq Stock Market and on the Toronto Stock Exchange under the symbol “LGO”. For more information on the Company, please visit www.largoinc.com.

Cautionary Statement Regarding Forward-looking Information:

This press release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian and United States securities legislation. Forward‐looking information in this press release includes, but is not limited to, statements with respect to the timing and amount of estimated future production and sales; the future price of commodities, ; costs of future activities and operations, including, without limitation, the effect of inflation and exchange rates; the timing and success of the commissioning and ramp up of the ilmenite plant,; the ability to sell ilmenite on a profitable basis, the successful vertical integration of the Company; the effect of unforeseen equipment maintenance or repairs on production; the ability to sufficiently reduce the cost of production through cost reduction measures;; the extent to which infill drilling data will create greater accuracy and reliability in the short-term mining plan and production guidance, the extent of capital and operating expenditures; the impact of globalprice increases on the Company’s global supply chain and future sales of vanadium products. Forward‐looking information in this press release also includes, but is not limited to, statements with respect to our ability to build, finance and operate a VRFB business, our ability to protect and develop our technology, our ability to maintain our IP, the competitiveness of our product in an evolving market, our ability to market, sell and deliver our VCHARGE batteries on specification and at a competitive price, our ability to secure the required production resources to build and deploy our VCHARGE batteries, our ability to attract partners, collaborators and/or investors to build the VRFB business on terms attractive to the Company, and the adoption of VRFB technology generally in the market. Forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved”. All information contained in this news release, other than statements of current and historical fact, is forward looking information. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Largo or Largo Clean Energy to be materially different from those expressed or implied by such forward-looking statements, including but not limited to those risks described in the annual information form of Largo and in its public documents filed on www.sedar.com and available on www.sec.gov from time to time. Forward-looking statements are based on the opinions and estimates of management as of the date such statements are made. Although management of Largo has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Largo does not undertake to update any forward-looking statements, except in accordance with applicable securities laws. Readers should also review the risks and uncertainties sections of Largo’s annual and interim MD&As which also apply.

Trademarks are owned by Largo Inc.

1 Conversion of tonnes to pounds, 1 tonne = 2,204.62 pounds or lbs.
2 Effective grade represents the percentage of magnetic material mined multiplied by the percentage of V2O5 in the magnetic concentrate.
3 Global recovery is the product of crushing recovery, milling recovery, kiln recovery, leaching recovery and chemical plant recovery.

For further information:
Investor Relations
Alex Guthrie
Senior Manager, External Relations
+1.416.861.9778
[email protected]

Source: Largo Inc.

Release – CoreCivic Announces 2023 Second Quarter Earnings Release and Conference Call Dates

Posted on by [email protected]

Research News and Market Data on CXW

July 19, 2023

BRENTWOOD, Tenn., July 19, 2023 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (the Company) announced today that it will release its 2023 second quarter financial results after the market closes on Monday, August 7, 2023. A live broadcast of CoreCivic’s conference call will begin at 10:00 a.m. central time (11:00 a.m. eastern time) on Tuesday, August 8, 2023.

To participate via telephone and join the call live, please register in advance here https://register.vevent.com/register/BI245ce05fd4c64a6ead7845124358177d. Upon registration, telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number and a unique passcode.

Participants may access the audio-only webcast of the conference call from the Company’s website at www.corecivic.com under the “Events & Presentations” section of the “Investors” page. A replay of the webcast will be available for seven days.

About CoreCivic

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and believe we are the largest private owner of real estate used by government agencies in the United States. We have been a flexible and dependable partner for government for 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

Contact:Investors: Cameron Hopewell – Managing Director, Investor Relations – (615) 263-3024
Media: Steve Owen – Vice President, Communications – (615) 263-3107

Release – Salem Media Announces Management Changes

Posted on by [email protected]

Research News and Market Data on SALM

July 19, 2023 5:00am EDT

IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM) announced today some changes to the management structure of the company in a limited number of markets. These changes provide some cost savings and will allow Salem’s most seasoned leaders to expand their impact on the performance of the company.

  • Terry Fahy, Regional VP/GM for Los Angeles, will now also oversee Oxnard.
  • Steve Brodsky, GM for San Diego, will also manage Honolulu.
  • Dennis Hayes, GM for Portland, will now oversee Seattle as well.
  • Kevin Isaacs, GM for Cleveland, will now also manage Pittsburgh.
  • Mark Durkin, Regional VP/GM for Sacramento, will also manage Phoenix.

Earlier this year, Salem made similar changes with:

  • Carolyn Cassidy managing both Tampa and Columbus.
  • John Gallagher managing both Chicago and Little Rock.

In some cases, the former GM will stay on in a sales/sales management role.

Salem CEO, David Santrella, said “These changes were made to allow Salem to continue to innovate and invest in our business and to allow the very best leaders to oversee our radio stations.”

Some other changes were made as well. Salem is combining the sales efforts of Salem Media Reps and the Salem Web Network with the combined sales team reporting to Mike Reed and Mike DeAmicis at Salem Media Reps.

David Evans, Salem COO said, “This unified sales team will now have easier access to all digital assets within our company to more fully grow into a ‘One-World’ company that offers ministries, advertisers, and our audiences’ multiple platforms with which to consume content and reach communities.”

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/20230714305565/en/

Evan D. Masyr
Executive Vice President and Chief Financial Officer
(805) 384-4512
[email protected]

Source: Salem Media Group

Released July 19, 2023

Release – Snail, Inc. Announces Updates for Expedition Agartha and DEDsafío Event Success Featuring ARK: Survival Evolved

Posted on by [email protected]

Research News and Market Data on SNAL

July 19, 2023 at 7:52 AM EDT

CULVER CITY, Calif., July 19, 2023 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail”), a leading, global independent developer and publisher of interactive digital entertainment, today announced the upcoming major updates for the first-person looter survival game, Expedition Agartha, and the highlight of the recent DEDsafío event featuring ARK: Survival Evolved.

Snail’s indie gaming subsidiary, Wandering Wizard, in collaboration with Matrioshka Games, has scheduled the release of the Skill Tree update and Server Wipe for Expedition Agartha on August 1. Until this date, the game’s PTR server will remain active, encouraging players to provide additional feedback or suggestions.

Furthermore, the DEDsafío event, held on July 12, drew participation from 75 streamers, expanding the reach of Snail’s well-received game, ARK: Survival Evolved. During the DEDsafío event, ARK: Survival Evolved achieved a prominent viewership status worldwide on YouTube Gaming Live, garnering around 61,000 viewers at its peak. ARK: Survival Evolved also ranked in the top 10 games on Twitch in Latin America and received noteworthy visibility on KICK’s live channels, a new streaming platform. Westcol, a streamer who participated in the DEDsafío event, attracted over 18,000 viewers while live streaming his gameplay of ARK: Survival Evolved on KICK. These developments highlight Snail’s commitment to providing engaging and quality content for the global gaming community and its promotion across diverse platforms.

“Snail continues to prioritize the enhancement of our gaming portfolio and active engagement with our player community,” said Jim Tsai, Chief Executive Officer of Snail. “The forthcoming Expedition Agartha updates and the well-attended DEDsafío event are indicative of our dedication to enhance the visibility and success of our games. We anticipate a continuation of strong player engagement and growth in our diverse game portfolio in the future.”

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:

[email protected]

Release – Salem Media Announces the Passing of its Co-founder Stuart Epperson Sr.

Posted on by [email protected]

Research News and Market Data on SALM

July 17, 2023 4:56pm EDT

IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM) with a heavy heart, announced today the passing of co-founder, Stuart Epperson. He was 86. Stuart, along with his brother-in-law, Edward Atsinger, founded Salem Communications (now Salem Media Group) in 1986 and expanded Salem’s influence with Christian and politically conservative News Talk formatted radio stations and media assets nationwide. Mr. Epperson was a longtime leader in Christian radio as a former member of the board of directors of the National Religious Broadcasters Association. In 2005, Time Magazine named him one of the 25 most influential evangelicals in America. Stuart was involved in several other conservative organizations dedicated to preserving Judeo Christian values in our culture through public policy. He was a member and the past president of the conservative Council for National Policy (“CNP”). In 1984 and 1986, Epperson was the Republican nominee for the fifth Congressional district of North Carolina.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230717970556/en/

Stuart Epperson Sr. (Photo: Business Wire)

Epperson attended Bob Jones University in Greenville, South Carolina, where he received a bachelor’s degree in radio/television broadcasting and a master’s degree in communications. Epperson is survived by his wife, Nancy, his four children, daughters Kristy, Karen, and Kathy, and son Stuart Jr. and by 21 grandchildren, 1 great grandchild and 2 more on the way, as well as a sister, Mary Lee King.

Salem Media Group Executive Chairman Ed Atsinger commented: “Stuart will be greatly missed by many. I will miss him, but I take comfort in realizing that he is already receiving his reward for a life well-lived. A life that personifies the words of the Apostle Paul in 2 Timothy 4:7-8: ‘I have fought the good fight. I have finished the race. Now there Is in store for me the crown of righteousness, which the Lord, the righteous Judge, will award to me on that day and not only to me, but also to all who have longed for his appearing.’”

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/20230717970556/en/

Evan D. Masyr
Executive Vice President and Chief Financial Officer
(805) 384-4512
[email protected]

Source: Salem Media Group, Inc.

Released July 17, 2023

Release – ZyVersa Therapeutics Announces Publication in the Journal, Hepatology, Highlighting the Role of NLRP3 Inflammasome-Mediated IL-18 in Development of Liver Fibrosis

Posted on by [email protected]

Research News and Market Data on ZVSA

Jul 17, 2023

  • Liver fibrosis is a progressive form of chronic liver injury mediated by persistent NLRP3 inflammasome activation in liver cells called hepatic stellate cells (“HSCs”), which leads to the development of cirrhosis and liver cancer
  • Inflammasome NLRP3 activation leads to production of the proinflammatory cytokines, IL-1β and IL-18, and IL-18 activates HSCs resulting in liver fibrosis
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which can inhibit up to 12 different inflammasomes (including NLRP3 inflammasomes) and their associated ASC specks which perpetuate damaging inflammation through ongoing production of IL-1β and IL-18

WESTON, Fla., July 17, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of an article in the peer-reviewed journal, Hepatology, demonstrating the role of NLRP3 inflammasome-mediated IL-18 in the development of liver fibrosis.

In the paper titled, “Interleukin‐18 signaling promotes activation of hepatic stellate cells in mouse liver fibrosis,” the authors evaluated serum levels of IL-18 in patients diagnosed with liver fibrosis/cirrhosis, and they conducted studies in three different mouse models of liver fibrosis. Following are key findings reported in the paper:

  • Levels of circulating IL‐18 and IL‐18 binding protein were elevated in patients with liver fibrosis/cirrhosis in comparison to healthy controls
  • Data in liver fibrosis mouse models provided strong evidence that IL-18 signaling and its downstream effects have a pivotal role in the development of liver fibrosis (fibrogenesis)
  • The pivotal role of IL-18 signaling in liver fibrosis was confirmed in IL-18 deficient mice, which showed protection from fibrotic liver changes

The authors stated, “Our results highlight the pivotal role of IL-18 signaling in liver fibrogenesis through the activation of HSCs in vitro and in vivo in three different mouse models.” To read the article, Click Here.

“The research published in the Hepatology demonstrated that NLRP3 inflammasome-mediated activation of IL-18 has a pivotal role in liver fibrosis, providing support for inflammasome inhibition as a promising treatment. Unlike NLRP3 inhibitors, which only inhibit formation of the NLRP3 inflammasome to block initiation of the inflammatory cascade, Inflammasome ASC inhibitor IC 100 inhibits formation of multiple types of inflammasomes, and it uniquely inhibits ASC specks to block perpetuation of damaging inflammation,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: 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 for treatment of 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 planned preclinical 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
[email protected]
786-251-9641       

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
[email protected]
646-577-8520

Dave Schemelia
[email protected]
609-468-9325

Release – Century Lithium Appoints New Director

Posted on by [email protected]

Research News and Market Data on CYDVF

July 17, 2023 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (“Century Lithium” or “the Company”) is pleased to announce the appointment of Dr. Corby G. Anderson to its Board of Directors, effective July 14, 2023.

Dr. Anderson is a Licensed Professional Chemical Engineer with over 40 years of global experience in engineering, design, industrial plant operations, corporate level management, education, research, and professional service. He holds degrees of BSc in Chemical Engineering from Montana State University, an MSc in Metallurgical Engineering from Montana Tech, and a PhD in Mining Engineering and Metallurgy from the University of Idaho. He most recently assisted Century Lithium as its Technical Advisor, Metallurgy.

“We are pleased to welcome Dr. Anderson to the Company’s Board of Directors” said Bryan Disher, Chair of Century Lithium. “As Technical Advisor, Dr. Anderson has been instrumental in the advancement of our Clayton Valley Lithium Project, and we look forward to his continued contribution to the Company in his new role on the Board of Directors”.

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
[email protected] 
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 – PDS Biotech Announces Acceptance of Abstract on Combination of PDS0301 with Docetaxel in Metastatic Prostate Cancer for Oral Presentation by the National Cancer Institute at Cytokines 2023

Posted on by [email protected]

Research News and Market Data on PDSB



First clinical study of immunocytokine with docetaxel in prostate cancer patients

FLORHAM PARK, N.J., July 17, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T cell activating technologies, today announced that an abstract reporting on interim data from a first-in-human clinical trial evaluating the combination of PDS0301, an IL-12-based immunocytokine, with the chemotherapy medication docetaxel has been accepted for oral presentation at the 11th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2023).

The abstract, titled, “Combining an IL-12-based Immunocytokine (PDS0301) with Docetaxel in Metastatic Prostate Cancer: Preliminary Safety and Immune Data”, will report interim safety and immune data on 18 patients in the clinical trial being led by the National Cancer Institute (NCI), part of the National Institutes of Health. The trial is investigating the safety, immune responses and clinical activity of PDS0301 and docetaxel in metastatic castration-sensitive and castration-resistant prostate cancer patients. The study is designed to evaluate three dose levels of PDS0301 (8 mcg/kg, 12 mcg/kg, and 16.8 mcg/kg) in combination with docetaxel (75 mg/m2) administered every three weeks.

“We look forward to Dr. Ravi Madan’s presentation of the interim safety, clinical outcomes and immune correlates for PDS0301 administered in combination with standard of care docetaxel in patients with advanced prostate cancer,” stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “This clinical trial provides an important opportunity to investigate the potential of PDS0301 combined with docetaxel chemotherapy to offer improved treatment options for patients with metastatic castration-sensitive and castration-resistant forms of prostate cancer. The results of this study could provide insight into the potential use of PDS0301 with chemotherapy across multiple solid tumors.”

Abstract Title: Combining an IL-12-based Immunocytokine (PDS0301) with Docetaxel in Metastatic Prostate Cancer: Preliminary Safety and Immune Data
Paper Number: 249
Presenting Author: Head, Prostate Cancer Clinical Research Section, Ravi A. Madan
Authors: Renee Donahue, Yo-Ting Tsai, Mohammad O. Atiq, Elias Chandran, Luke Meininger, Fatima Karzai, Marijo Bilusic, Jennifer Marte, Philip M. Arlen, Lisa Cordes, Megan Hausler, Amy Hankin, Nikki Williams, William D. Figg, Jeff Schlom, James L. Gulley, Ravi A. Madan
Session Details: Plenary 3: Cytokines in Cancer Immunity and Immunotherapy, Mittwoch; Olympia A+B
Session Date and Time: October 18, 2023, 10:00-10:15

For patients interested in enrolling in this clinical trial, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY:  1-800-332-8615) and/or the Web site:  https://trials.cancer.gov and/or [email protected].

About PDS0301
PDS0301 is a novel investigational tumor-targeting antibody-conjugated Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells and natural killer (NK) cells in the tumor microenvironment. PDS0301 is given by subcutaneous injection and is designed to improve the safety profile of IL-12 and to enhance the anti-tumor response.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.
KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc.,
Rahway, N.J., USA.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

Media Contacts:
Tiberend Strategic Advisors, Inc.
Dave Schemelia
Phone: +1 (609) 468-9325
[email protected]

Eric Reiss
Phone: +1 (802) 249-1136
[email protected]

Release – Tonix Pharmaceuticals Announces Agreement and Initiation of Enrollment in Phase 2 Trial with the University of Washington to Study TNX-1900 (Potentiated Intranasal Oxytocin) for Social Anxiety Disorder

Posted on by [email protected]

Research News and Market Data on TNXP

July 17, 2023 7:00am EDT

Social Anxiety Disorder Affects 15 Million U.S. Adults and is More Common Among Women than Men

CHATHAM, N.J., July 17, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company, today announced that the first participant has been enrolled in a Phase 2 investigator-initiated, proof-of-concept study of TNX-1900 (potentiated intranasal oxytocin) for enhancing social safety learning in social anxiety disorder (SAD). Tonix entered into an agreement with the University of Washington to examine the potential role of TNX-1900 with Angela Fang, Ph.D., Assistant Professor, Department of Psychology, University of Washington as the principal investigator.

“We are excited to collaborate with the University of Washington and Dr. Fang on the development of TNX-1900 for social anxiety disorder,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “In the past decade, there has been an increase in studies examining oxytocin’s effects on social cognition and behavior in animals and humans due to translational discoveries showing that intranasal oxytocin appears to reach central nervous system targets1. Specifically, evidence suggests that oxytocin may enhance the importance of social cues or have anti-anxiety properties2,3. These studies have shown that intranasal oxytocin may hold therapeutic promise for psychiatric disorders involving social deficits3-5. TNX-1900 is a proprietary formulation of oxytocin that contains magnesium, which Tonix has shown in animal models potentiates the action of oxytocin at oxytocin receptors and potentially improves the consistency of treatment by reducing paradoxical high-dose inhibition.”

“For psychiatric disorders characterized by severe social avoidance, such as social anxiety disorder, social learning has been disproportionately understudied despite its role in the acquisition of fear in models of anxiety,” said Dr. Fang. “Social anxiety disorder is a disabling psychiatric disorder. Past research has focused on the observational, or vicarious, acquisition of fears, but little is known about how social information (such as observing others experiencing safety) can promote safety learning. To address this issue, we will study the effects of vicarious extinction learning on the recovery of conditioned fear.”

The Phase 2 study is a randomized, double-blind, placebo-controlled trial, such that all participants will be randomized to receive a single dose of either TNX-1900 or matching placebo nasal spray. 100 subjects are planned to enroll: 50 with a primary diagnosis of SAD, and 50 demographically-matched healthy controls. The primary objective of the Phase 2 study is to examine the potential role of TNX-1900 in enhancing vicarious extinction learning in SAD, compared to healthy controls.

About Social Anxiety Disorder

Social anxiety disorder (SAD) is characterized by persistent fear of one or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. The individual fears that he or she will act in a way (or show anxiety symptoms) that will be embarrassing and humiliating1. SAD affects 15 million adults or 7.1% of the U.S. population, is more common among women than men, and typically begins around age 135-8. Individuals with SAD report experiencing symptoms for 16 years before seeking help9.

1Lee MR, et al. Nat Commun. 2020. 11, 2783.
2Smith AS, et al. Pharmacol Res. 2019. 146, 104324.
3Domes G, et al. Biol Psychiatry. 2007. 62(10), 1187-90.
4Shamay-Tsoory SG, et al. Biol Psychiatry. 2016. 79(3), 194-202.
5Meyer-Lindenberg A, et al. Nat Rev Neurosci. 2011. 12, 524–538.
6Asher M & Aderka IM. J Clin Psychol. 2018. 74(10), 1730-1741.
7Asher M, et al. Clin Psychol Rev. 2017. 56, 1-12.
8Xu Y, et al. J Anxiety Disord. 2012. 26(1), 12-19.
9Wang PS, et al. Arch Gen Psychiatry. 2005. 62, 603-613.

About TNX-1900

TNX-1900 (intranasal potentiated oxytocin) is a proprietary formulation of oxytocin in development as a candidate for prevention of chronic migraine and other conditions. In 2020, TNX-1900 was acquired from Trigemina, Inc. who had licensed the technology underlying the composition and method from Stanford University. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Oxytocin is a naturally occurring human peptide hormone that also acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential. It has been observed that low oxytocin levels in the body are associated with increases in migraine headache frequency, and that increased oxytocin levels are associated with fewer migraine headaches. Certain other chronic pain conditions are also associated with decreased oxytocin levels. Migraine attacks are caused, in part, by the activity of pain-sensing trigeminal neurons which, when activated, release of calcitonin gene-related peptide (CGRP) which binds to receptors on other nerve cells and starts a cascade of events that is believed to result in headache. Oxytocin when delivered via the nasal route, concentrates in the trigeminal system3 resulting in binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting the release of CGRP and transmission of pain signals returning from the site of CGRP release.4 Blocking CGRP release is a distinct mechanism compared with CGRP antagonist and anti-CGRP antibody drugs, which block the binding of CGRP to its receptor. With TNX-1900, the addition of magnesium to the oxytocin formulation enhances oxytocin receptor binding5 as well as its inhibitory effects on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models7. Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children6. Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects, which could potentially occur with systemic CGRP antagonists such as anti-CGRP antibodies8. For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. The Company believes nasally targeted delivery of oxytocin could translate into selective blockade of CGRP release from neurons in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition. In addition, daily dosing is more rapidly reversible, in contrast to monthly or quarterly dosing, as is the case with anti-CGRP antibodies, giving physicians and their patients greater control. In addition to chronic migraine, TNX-1900 will be developed for treatment of episodic migraine, binge eating disorder, craniofacial pain conditions, and insulin resistance. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions.

1NIH, National Institute of Mental Health
2Anxiety & Depression Association of America
3Yeomans DC, et al. Transl Psychiatry. 2021. 11(1):388
4Tzabazis A, et al. Cephalalgia. 2016. 36(10):943-50.
5Antoni FA & Chadio SE. Biochem J. 1989. 257(2):611-4
6Yeomans DC, et al. 2017. US patent US2017368095
7Cai Q, et al. Psychiatry Clin Neurosci. 2018. 72(3):140-151
8MaassenVanDenBrink A, et al. Trends Pharmacol Sci. 2016. 37(9):779-788

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 markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. 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 CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with topline data expected in the first quarter of 2024. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with topline results expected in the first quarter of 2024. TNX-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. 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 is expected to be 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, 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.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are the property of their respective owners.

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

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 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
[email protected]
(862) 904-8182

Peter Vozzo
ICR Westwicke
[email protected]
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
[email protected]
(919) 360-3039

Zembrace® SymTouch® (sumatriptan Injection):   IMPORTANT SAFETY INFORMATION

Zembrace SymTouch (Zembrace) can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Zembrace is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, dihydroergotamine.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Zembrace include: pain and redness at injection site; tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired.

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace. For more information, ask your provider.

This is the most important information to know about Zembrace but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE

Zembrace is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace is not used to prevent migraines. It is not known if it is safe and effective in children under 18 years of age.

Tosymra® (sumatriptan nasal spray): IMPORTANT SAFETY INFORMATION

Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Tosymra is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem.

Do not use Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • severe liver problems
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your healthcare provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider if you are not sure if your medicine is listed above.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any ingredient in Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Tosymra include: tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Tosymra. For more information, ask your provider.

This is the most important information to know about Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE
Tosymra is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

Tosymra is not used to treat other types of headaches such as hemiplegic or basilar migraines or cluster headaches.

Tosymra is not used to prevent migraines. It is not known if Tosymra is safe and effective in children under 18 years of age.

Source: Tonix Pharmaceuticals Holding Corp.

Released July 17, 2023