Release – AI Integrated into Conduent Life@Work® Connect with Jellyvision and TALON to Educate Employees about Open Enrollment and Maximize Healthcare Benefit Spend

Research News and Market Data on CNDT

November 04, 2024

Benefits Administration Solutions Human Resource Services

51% of U.S. adults find their health insurance plan difficult to understand

Conduent’s enhanced platform now provides a stronger employee experience to create a holistic view of health and wellness benefits and costs

FLORHAM PARK, N.J. — Conduent Incorporated (Nasdaq: CNDT), a global technology-led business solutions and services company, announced the integration of AI-driven solutions by TALON and Jellyvision’s ALEX with its Life@Work Connect Experience Platform, to elevate employee understanding of their personal health and wellness benefits. With the addition of Jellyvision and TALON, Life@Work Connect integrates additional uses of AI with two new employee resources in its digital portal that help employees navigate open enrollment more easily and maximize their healthcare benefits throughout the year.

Integrated tools for benefits decisions, education and optimization

  • ALEX, Jellyvision’s benefits decision support advisor, engages employees to guide them through their entire benefits package, taking into consideration an individual’s personal level of risk tolerance, their unique health, family, and lifestyle, and then offers personalized benefits recommendations.
  • TALON’s price transparency tool helps employees identify and navigate to low-cost, high quality, in-network providers, with over 10,000 services and procedures searchable for accurate, precise out-of-pocket cost-comparison.

By integrating educational and price-transparency solutions into its Life@Work Connect platform, Conduent’s health and wellness administration solutions:

  • maximize employer investments in health care benefits, which is the second most expensive line item for employers after payroll.
  • increase employee understanding of their benefit plan options and costs.

“When companies improve the employee experience, like helping employees better understand their benefits, companies positively impact business metrics,” said John Larson, Vice President for Total Benefit Solutions at Conduent. “When clients work with Conduent as a health and wellness benefits administrator, we bring together our capabilities and experience with multiple decision tools into a single seamless and digital employee experience that drives engagement and business outcomes.”

“ALEX develops deep trust with users with bits of humor and delight woven into the benefit plan selection. You have to build trust with an individual to encourage them to change behaviors. We know ALEX is having an impact that translates into tangible results. Employee reports show they are making more preventative healthcare appointments, are better able to meet their health goals, and almost 90% say they understand their benefits more after talking with ALEX,” said Brian Meager, President of Jellyvision.

“Once employees have selected their health plan, they are often confused about how to optimize their benefits. TALON’s data shows a huge opportunity to help employees save on out-of-pocket healthcare expenses,” said Mark Galvin, CEO at TALON. “By providing employees with the ability to comparison shop means they are getting real and measurable benefits. For instance, employees who searched and shopped for various blood tests saved as much as 95% off the highest-cost in-network provider and over 25% compared to employees who didn’t shop.”

Health and wellness administration provider Conduent, benefits advisor ALEX from Jellyvision and TALON’s health care price transparency platform can enable better health and wellness outcomes for employees with solutions that align budget, benefits strategy and goals.

About Conduent

Conduent delivers digital business solutions and services spanning the commercial, government and transportation spectrum – creating valuable outcomes for its clients and the millions of people who count on them. The Company leverages cloud computing, artificial intelligence, machine learning, automation and advanced analytics to deliver mission-critical solutions. Through a dedicated global team of approximately 55,000 associates, process expertise and advanced technologies, Conduent’s solutions and services digitally transform its clients’ operations to enhance customer experiences, improve performance, increase efficiencies and reduce costs. Conduent adds momentum to its clients’ missions in many ways including disbursing approximately $100 billion in government payments annually, enabling 2.3 billion customer service interactions annually, empowering millions of employees through HR services every year and processing nearly 13 million tolling transactions every day. Learn more at www.conduent.com.

Note: To receive RSS news feeds, visit www.news.conduent.com. For open commentary, industry perspectives and views, visit http://twitter.com/Conduenthttp://www.linkedin.com/company/conduent or http://www.facebook.com/Conduent.

Trademarks

Conduent is a trademark of Conduent Incorporated in the United States and/or other countries. Other names may be trademarks of their respective owners.

Media Contacts

Lisa Patterson

Conduent

lisa.patterson@conduent.com

+1-816-305-4421

Giles Goodburn

Conduent

ir@conduent.com

+1-203-216-3546

Jellyvision

press@jellyvision.com

Matthew McCormick

TALON

matthew.mccormick@talonhealthtech.com

Release – SelectQuote, Inc. Reports First Quarter of Fiscal Year 2025 Results

Research News and Market Data on SLQT

11/04/2024

First Quarter of Fiscal Year 2025 – Consolidated Earnings Highlights

  • Revenue of $292.3 million
  • Net loss of $44.5 million
  • Adjusted EBITDA* of $(1.7) million

Fiscal Year 2025 Guidance Ranges:

  • Revenue expected in a range of $1.425 billion to $1.525 billion
  • Net income (loss) expected in a range of $(59) million to $3 million
  • Adjusted EBITDA* expected in a range of $100 million to $130 million

First Quarter Fiscal Year 2025 – Segment Highlights

Senior

  • Revenue of $92.9 million
  • Adjusted EBITDA* of $7.7 million
  • Approved Medicare Advantage policies of 91,680

Healthcare Services

  • Revenue of $155.7 million
  • Adjusted EBITDA* of $4.9 million
  • 86,521 SelectRx members

Life

  • Revenue of $39.3 million
  • Adjusted EBITDA* of $6.0 million

OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT) reported consolidated revenue for the first quarter of fiscal year 2025 of $292.3 million compared to consolidated revenue for the first quarter of fiscal year 2024 of $232.7 million. Consolidated net loss for the first quarter of fiscal year 2025 was $44.5 million compared to consolidated net loss for the first quarter of fiscal year 2024 of $31.1 million. Finally, consolidated Adjusted EBITDA* for the first quarter of fiscal year 2025 was $(1.7) million compared to consolidated Adjusted EBITDA* for the first quarter of fiscal year 2024 of $(11.4) million.

SelectQuote Chief Executive Officer, Tim Danker, remarked, “SelectQuote opened our fiscal 2025 with a strong quarter and our holistic approach to healthcare connectivity between Americans in need of care, and the insurers and caregivers that provide it, has never been more valuable. As reported in the market, benefit coverage for Medicare Advantage plans shifted significantly this season, and we are pleased to say that both seniors and insurance carriers have increasingly turned to SelectQuote’s agent-led, true-choice platform to ensure individual care needs are met with the best plan available. When our customers and carrier partners benefit, so do our performance metrics and shareholders, and we proud of this alignment.”

Mr. Danker continued, “This quarter was also a success for our broadening Healthcare Services platform led by SelectRx. Our bespoke prescription drug service now has over 86 thousand members, which represents growth of over 64% compared to a year ago. Separately, SelectQuote recently announced our initial receivable securitization, which was a critical first step in our ongoing strategy to improve our capital flexibility.”

“We look forward to sharing our AEP results next quarter and are excited by the value our differentiated model continues to provide to a large and growing population of American seniors,” Mr. Danker concluded.

* See “Non-GAAP Financial Measures” below.

Segment Results

We currently have three reportable segments: 1) Senior, 2) Healthcare Services and 3) Life. The performance measures of the segments include total revenue and Adjusted EBITDA.* Costs of commissions and other services revenue, cost of goods sold-pharmacy revenue, marketing and advertising, selling, general, and administrative, and technical development operating expenses that are directly attributable to a segment are reported within the applicable segment. Indirect costs of revenue, marketing and advertising, selling, general, and administrative, and technical development operating expenses are allocated to each segment based on varying metrics such as headcount. Adjusted EBITDA is our segment profit measure to evaluate the operating performance of our business. We define Adjusted EBITDA as net loss plus: (i) interest expense, net; (ii) expense (benefit) for income taxes; (iii) depreciation and amortization; (iv) share-based compensation; (v) goodwill, long-lived asset, and intangible assets impairments; (vi) transaction costs; (vii) loss on disposal of property, equipment and software, net; and (viii) other non-recurring expenses and income. Adjusted EBITDA Margin is calculated as Adjusted EBITDA divided by revenue.

Earnings Conference Call

SelectQuote, Inc. will host a conference call with the investment community on November 4, 2024, beginning at 8:30 a.m. ET. To register for this conference call, please use this link: https://registrations.events/direct/Q4I1559258472. After registering, a confirmation will be sent via email, including dial-in details and unique conference call codes for entry. Registration is open through the live call, but to ensure you are connected for the full call we suggest registering at least 10 minutes before the start of the call. The event will also be webcasted live via our investor relations website https://ir.selectquote.com/investor-home/default.aspx.

Non-GAAP Financial Measures

This release includes certain non-GAAP financial measures intended to supplement, not substitute for, comparable GAAP measures. To supplement our financial statements presented in accordance with GAAP and to provide investors with additional information regarding our GAAP financial results, we have presented in this release Adjusted EBITDA and Adjusted EBITDA Margin, which are non-GAAP financial measures. These non-GAAP financial measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similarly titled measures presented by other companies. We define Adjusted EBITDA as net income (loss) before interest expense, income tax expense (benefit), depreciation and amortization, and certain add-backs for non-cash or non-recurring expenses, including restructuring and share-based compensation expenses. The most directly comparable GAAP measure is net income (loss). We define Adjusted EBITDA Margin as Adjusted EBITDA divided by revenue. The most directly comparable GAAP measure is net income margin. We monitor and have presented in this release Adjusted EBITDA and Adjusted EBITDA Margin because they are key measures used by our management and Board of Directors to understand and evaluate our operating performance, to establish budgets, and to develop operational goals for managing our business. In particular, we believe that excluding the impact of these expenses in calculating Adjusted EBITDA can provide a useful measure for period-to-period comparisons of our core operating performance. We believe that these non-GAAP financial measures help identify underlying trends in our business that could otherwise be masked by the effect of the expenses that we exclude in the calculations of these non-GAAP financial measures. Accordingly, we believe that these financial measures provide useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects. Reconciliations of net income (loss) to Adjusted EBITDA are presented below beginning on page 13.

Forward Looking Statements

This release contains forward-looking statements. These forward-looking statements reflect our current views with respect to, among other things, future events and our financial performance. These statements are often, but not always, made through the use of words or phrases such as “may,” “should,” “could,” “predict,” “potential,” “believe,” “will likely result,” “expect,” “continue,” “will,” “anticipate,” “seek,” “estimate,” “intend,” “plan,” “projection,” “would” and “outlook,” or the negative version of those words or other comparable words or phrases of a future or forward-looking nature. These forward-looking statements are not historical facts, and are based on current expectations, estimates and projections about our industry, management’s beliefs and certain assumptions made by management, many of which, by their nature, are inherently uncertain and beyond our control. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.

There are or will be important factors that could cause our actual results to differ materially from those indicated in these forward-looking statements, including, but not limited to, the following: impacts of the COVID-19 pandemic and any other significant public health events; our reliance on a limited number of insurance carrier partners and any potential termination of those relationships or failure to develop new relationships; existing and future laws and regulations affecting the health insurance market; changes in health insurance products offered by our insurance carrier partners and the health insurance market generally; insurance carriers offering products and services directly to consumers; changes to commissions paid by insurance carriers and underwriting practices; competition with brokers, exclusively online brokers and carriers who opt to sell policies directly to consumers; competition from government-run health insurance exchanges; developments in the U.S. health insurance system; our dependence on revenue from carriers in our senior segment and downturns in the senior health as well as life, automotive and home insurance industries; our ability to develop new offerings and penetrate new vertical markets; risks from third-party products; failure to enroll individuals during the Medicare annual enrollment period; our ability to attract, integrate and retain qualified personnel; our dependence on lead providers and ability to compete for leads; failure to obtain and/or convert sales leads to actual sales of insurance policies; access to data from consumers and insurance carriers; accuracy of information provided from and to consumers during the insurance shopping process; cost-effective advertisement through internet search engines; ability to contact consumers and market products by telephone; global economic conditions, including inflation; disruption to operations as a result of future acquisitions; significant estimates and assumptions in the preparation of our financial statements; impairment of goodwill; our ability to regain and maintain compliance with NYSE listing standards; potential litigation and other legal proceedings or inquiries; our existing and future indebtedness; our ability to maintain compliance with our debt covenants; access to additional capital; failure to protect our intellectual property and our brand; fluctuations in our financial results caused by seasonality; accuracy and timeliness of commissions reports from insurance carriers; timing of insurance carriers’ approval and payment practices; factors that impact our estimate of the constrained lifetime value of commissions per policyholder; changes in accounting rules, tax legislation and other legislation; disruptions or failures of our technological infrastructure and platform; failure to maintain relationships with third-party service providers; cybersecurity breaches or other attacks involving our systems or those of our insurance carrier partners or third-party service providers; our ability to protect consumer information and other data; failure to market and sell Medicare plans effectively or in compliance with laws; and other factors related to our pharmacy business, including manufacturing or supply chain disruptions, access to and demand for prescription drugs, and regulatory changes or other industry developments that may affect our pharmacy operations. For a further discussion of these and other risk factors that could impact our future results and performance, see the section entitled “Risk Factors” in the most recent Annual Report on Form 10-K (the “Annual Report”) and subsequent periodic reports filed by us with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on any such forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made, and, except as otherwise required by law, we do not undertake any obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.

About SelectQuote:

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

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

Source: SelectQuote, Inc.

View the full release HERE.

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

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

Source: SelectQuote, Inc.

Release – Tonix Pharmaceuticals Announces Research Agreement with Kenya Medical Research Institute (KEMRI) to Design, Plan and Seek Regulatory Approval for a Phase I Clinical Study of TNX-801 for Mpox in Kenya

Research News and Market Data on TNXP

November 04, 2024 7:00am EST Download as PDF

Proposed clinical study in Kenya intended to test the safety, tolerability, and immunogenicity of TNX-801, a vaccine being developed to prevent mpox (formerly called monkeypox)

The World Health Organization (WHO) declared mpox a public health emergency of international concern (PHEIC) 1-4: cases of the new Clade Ib mpox detected in Sweden, Thailand, Singapore, India, Germany and England

In preclinical data, TNX-801, Tonix’s attenuated live-virus vaccine candidate, demonstrated efficacy as a vaccination against mpox in animal models

CHATHAM, N.J., Nov. 04, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it has entered into a sponsored research agreement with the Kenya Medical Research Institute (KEMRI) to design, plan and seek regulatory approval for a Phase I clinical study in Kenya to test the safety, tolerability, and immunogenicity of TNX-801 (horsepox, live virus) as a vaccine to prevent mpox and smallpox. Tonix will be the sponsor and KEMRI will lead the execution of the proposed clinical trial.

“We are excited to advance development of TNX-801 under this research agreement with KEMRI,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There is an urgent need for the worldwide availability of a single dose mpox vaccine with durable protection. TNX-801 has demonstrated encouraging preclinical data and was recently shown to align with the World Health Organization’s (WHO’s) newly issued preferred target product profile (TPP) for mpox vaccines. Further, TNX-801 can be scaled up for manufacturing, distribution and storage without a costly supply chain. We believe TNX-801 has the potential to address and help interrupt the spread of mpox worldwide.”

In September 2024, Tonix announced that the preferred target product profile (TPP), released at the WHO sponsored Mpox Research and Innovation Scientific Conference, aligns with the potential characteristics of TNX-801. Key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment, and stability at ambient temperature. Other potential beneficial characteristics include the ability to limit forward transmission, use in case-contact vaccination strategies and suitability for use in immunocompromised individuals.

In August 2024, Tonix announced a collaboration with Bilthoven Biologics (Bbio) to develop GMP manufacturing processes for TNX-801. Bbio is part of the world’s largest vaccine manufacturer, the Cyrus Poonawalla Group, which also includes the Serum Institute of India.

About TNX-801*

TNX-801 is a live minimally-replicating attenuated horsepox vaccine that is believed to provide immune protection against mpox in animals with better tolerability than 20th century vaccinia viruses. Vaccinia vaccines from the 20th century are descendants of Edward Jenner’s circa 1800 that have become more virulent in connection with losing regulatory elements in their genomes. Given the modern understanding that Jenner’s circa 1800 vaccine would be called “horsepox” today, TNX-801 was designed to be similar to Jenner’s vaccine. After a single dose vaccination, TNX-801 protected animals against lethal challenge with intratracheal Clade Ia monkeypox virus.5 In this experiment, TNX-801 vaccination prevented clinical disease and skin lesions and also decreased shedding in the mouth and lungs. The findings are consistent with mucosal immunity and suggest the ability to block forward transmission. In addition, TNX-801 has decreased virulence in immunocompromised animals relative to 20th Century vaccinia viruses.6 Based on animal studies, TNX-801 combines immune protection with improved tolerability compared to live-virus vaccinia vaccines. TNX-801 is administered with a single dose which has advantages over two-dose regimens. The focus on single-dose vaccines confirms early recommendations by the Bipartisan Commission on Biodefense, 7 and the U.S. National Academies of Science.7,8 The National Academies of Science (NAS) report highlights the difficulty of a ring vaccination strategy with even a two-dose regimen.7 TNX-1800 is an engineered version of horsepox that expresses the spike protein of SARS-CoV-2. 9,10 The U.S. National Institutes of Health (NIH) selected Tonix’s COVID-19 vaccine, TNX-1800 for Project NextGen.

About Mpox*
On August 14, 2024, the WHO determined that the upsurge of mpox in a growing number of countries in Africa constitutes a PHEIC, the second such declaration in the past two years called in response to an mpox outbreak.1 The current outbreak is caused by Clade Ib monkeypox virus while the 2022 outbreak was caused by Clade IIb monkeypox virus. The 2022 global mpox outbreak, which is ongoing, has affected over 90,000 persons in countries where mpox had previously not been endemic, including Europe and the US. The rapid spread of Clade IIb strain mpox in 2022 underscores the pandemic potential of mpox. Unlike Clade IIb mpox, the Clade Ib strain of mpox appears to be spreading in Africa, particularly those neighboring the Democratic Republic of the Congo, including Burundi, Rwanda, and Uganda, but now affecting 16 countries. According to the U.S. Centers for Disease Control and Prevention (CDC), and other experts, there is a significant risk that the Clade Ib monkeypox may appear in the U.S.2,3

Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to progress TNX-102 SL, a product candidate for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and its development is supported by a grant from the U.S. National Institude of Drug Abuse and Addiction. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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

1WHO Press Release August 14, 2024. “WHO Director-General declares mpox outbrfeak a public health emergency of international concern”. URL: www.who.int/news/item/14-08-2024-who-director-general-declares-mpox-outbreak-a-public-health-emergency-of-international-concern (accessed 8-15-24)
2McQuiston JH, et al. U.S. Preparedness and Response to Increasing Clade I Mpox Cases in the Democratic Republic of the Congo. 2024, MMWR Morbi Mortal Wkly Rep: United States. p. 435-440
3CDC. 2022-2023 Mpox: US Map and Case Count. https://www.cdc.gov/poxvirus/mpox/response/2022/us-map.html
4World Health Organization SAGE meeting highlights on updated mpox vaccine recommendations. 2024, March
5Noyce RS, et al. Viruses. 2023 Jan 26;15(2):356. Doi: 10.3390/v15020356. PMID: 36851570; PMCID: PMC9965234
6Trefry, SV et al. bioRxiv 2023.10.25.564033; doi: https://doi.org/10.1101/2023.10.25.564033
7Bipartisan Commission on Biodefense. Box the Pox: Reducing the risk of Smallpox and Other Ortho poxviruses, Washington:2024
8U.S. National Academies of Science. Future State of Smallpox Medical Countermeasures. Washington:2024
9Awasthi M, et al. Viruses. 2023 Oct 21;15(10):2131. Doi: 10.3390/v15102131. PMID: 37896908; PMCID: PMC10612059.
10Awasthi M et al Vaccines (Basel). 2023 Nov 2;11(11):1682. Doi: 10.3390/vaccines11111682.PMID: 38006014

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 Toni’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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Toni’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

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released November 4, 2024

Release – Beasley Broadcast Group to Report 2024 Third Quarter Financial Results, Host Conference Call and Webcast on November 5

Research News and Market Data on BBGI

November 01, 2024

NAPLES, Fla., Nov. 01, 2024 (GLOBE NEWSWIRE) — Beasley Broadcast Group, Inc. (Nasdaq: BBGI) (“Beasley” or the “Company”), a multi-platform media company, announced today that it will report its 2024 third quarter financial results before the market opens on Tuesday, November 5, 2024. The Company will host a conference call and webcast at 11:30 a.m. ET that morning to review the results.

To access the conference call, interested parties may dial 877-407-4018 or 201-689-8471, conference ID  13749767 (domestic and international callers). Participants can also listen to a live webcast of the call at the Company’s website at www.bbgi.com. Please allow 15 minutes to register and download and install any necessary software. Following its completion, a replay of the webcast can be accessed for five days on the Company’s website, www.bbgi.com.

Questions from analysts, institutional investors and debt holders may be e-mailed to ir@bbgi.com at any time up until 9:00 a.m. ET on November 5, 2024. Management will answer as many questions as possible during the conference call and webcast (provided the questions are not addressed in their prepared remarks).

About Beasley Broadcast Group
The Company is a multi-platform media company whose primary business is operating radio stations throughout the United States. The Company offers local and national advertisers integrated marketing solutions across audio, digital and event platforms. The Company owns and operates 57 AM and FM stations in the following large- and mid-size markets in the United States: Atlanta, GA, Augusta, GA, Boston, MA, Charlotte, NC, Detroit, MI, Fayetteville, NC, Fort Myers-Naples, FL, Las Vegas, NV, Middlesex, NJ, Monmouth, NJ, Morristown, NJ, Philadelphia, PA, and Tampa-Saint Petersburg, FL. Approximately 20 million consumers listen to the Company’s radio stations weekly over-the-air, online and on smartphones and tablets, and millions regularly engage with the Company’s brands and personalities through digital platforms such as Facebook, X, text, apps and email. For more information, please visit www.bbgi.com.

For further information, or to receive future Beasley Broadcast Group news announcements via e-mail, please contact Beasley Broadcast Group, at 239-263-5000 or email@bbgi.com, or Joseph Jaffoni, JCIR, at 212-835-8500 or bbgi@jcir.com.

CONTACT:
Heidi Raphael
Chief Communications Officer
Beasley Broadcast Group, Inc.
239-263-5000 or email@bbgi.com 
Joseph Jaffoni, Jennifer Neuman
JCIR
212-835-8500 or bbgi@jcir.com

Dollar Declines as Investors Pull Back from ‘Trump Trades’ Amid Election and Fed Rate Cut Anticipation

Key Points:
– The dollar hit a two-week low, driven by election uncertainty and profit-taking on “Trump trades.”
– Investors anticipate a 0.25% Fed rate cut on Thursday, with further cuts likely in early 2025.
– The Bank of England and other central banks are also expected to ease rates amid market volatility.

The U.S. dollar fell to a two-week low on Monday, with investors taking profits from “Trump trades” ahead of the closely contested U.S. election and an expected Federal Reserve rate cut. The euro gained 0.7% to $1.0906, while the dollar weakened by nearly 1% against the yen to 151.645, and the dollar index slipped to 103.65.

Markets are seeing increased volatility as the presidential race between Democratic candidate Kamala Harris and Republican Donald Trump tightens. Polls show a slight edge for Harris in key battleground states like Nevada, North Carolina, and Wisconsin, leading some investors to unwind dollar positions they had previously built around a potential Trump win. Betting markets have also shifted, with odds for a Trump victory narrowing over the last week.

Kenneth Broux, Societe Generale’s head of corporate research in FX and rates, noted that investors are adjusting positions in response to new polling data, which showed Harris slightly ahead in some swing states. “Markets are very stretched – long dollars, short Treasuries – into the vote tomorrow, so it’s only natural we are adjusting some of that positioning,” Broux explained.

With a potentially ambiguous outcome, traders are also pricing in a high likelihood of post-election volatility. Options markets show increased demand for protection against market swings, with the one-week implied volatility for euro/dollar reaching its highest since early 2023. Implied volatility is also elevated for the Chinese offshore yuan and the Mexican peso, highlighting concerns about trade and economic policy changes following the election.

Alongside election jitters, the Federal Reserve’s policy decision this week is another key focus. The central bank is expected to announce a quarter-point rate cut on Thursday, marking a departure from the larger 0.5% cut implemented previously. CME’s FedWatch tool shows a 98% probability of this smaller rate reduction, with market odds favoring further cuts through early 2025. According to Jan Hatzius, an economist at Goldman Sachs, the Fed’s projected path for rates appears more dovish than current market pricing, with Hatzius suggesting four consecutive cuts in early 2025.

The Bank of England (BoE) is also set to meet this Thursday, where it is expected to implement a 0.25% rate cut amid recent bond market volatility and concerns about the UK’s fiscal policy. Following the Labour government’s recent budget, UK gilts saw a steep selloff, and the British pound briefly dipped before rebounding to $1.29820. Meanwhile, other central banks, including the Riksbank and the Norges Bank, are anticipated to make dovish policy moves this week, with the Riksbank expected to ease rates by 0.5% and the Norges Bank likely to hold steady.

In Asia, the Reserve Bank of Australia is expected to keep rates unchanged at its Tuesday meeting, while China’s National People’s Congress, which convenes this week, is expected to announce further economic stimulus measures.

The interplay between the U.S. election and potential rate cuts from major central banks has intensified uncertainty in the currency markets, as investors monitor for clues on how fiscal and monetary policy shifts will shape the global economic outlook.

Cumulus Media (CMLS) – Revenue Visibility Still Murky


Monday, November 04, 2024

Cumulus Media (NASDAQ: CMLS) is an audio-first media company delivering premium content to over a quarter billion people every month — wherever and whenever they want it. Cumulus Media engages listeners with high-quality local programming through 406 owned-and-operated radio stations across 86 markets; delivers nationally-syndicated sports, news, talk, and entertainment programming from iconic brands including the NFL, the NCAA, the Masters, CNN, the AP, the Academy of Country Music Awards, and many other world-class partners across more than 9,500 affiliated stations through Westwood One, the largest audio network in America; and inspires listeners through the Cumulus Podcast Network, its rapidly growing network of original podcasts that are smart, entertaining and thought-provoking. Cumulus Media provides advertisers with personal connections, local impact and national reach through broadcast and on-demand digital, mobile, social, and voice-activated platforms, as well as integrated digital marketing services, powerful influencers, full-service audio solutions, industry-leading research and insights, and live event experiences. Cumulus Media is the only audio media company to provide marketers with local and national advertising performance guarantees. For more information visit www.cumulusmedia.com.

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

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

In-line Q3 results. The company reported revenue of $203.6 million and adj. EBITDA of $24.1 million, in-line with our estimates of $203.3 million and $24.8 million, respectively. Its digital businesses, now 20% of total revenues, was the highlight of the quarter, up 7.5% from the prior year. Political advertising was a little softer than expected, $4.4 million versus our $5.5 million estimate. 

National/Network remains lackluster. National advertising is over 50% of total company revenues and carries very high margins. A recovery in National/Network will be key toward improved company fundamentals. Management indicated that National advertisers appear to be hesitant to spend, possibly due to economic uncertainty and concerns over the upcoming presidential elections. 


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Comtech Telecommunications (CMTL) – Releases Full Year Results; Removes “Interim” Tag From CEO


Monday, November 04, 2024

Comtech Telecommunications Corp. engages in the design, development, production, and marketing of products, systems, and services for advanced communications solutions in the United States and internationally. It operates in three segments: Telecommunications Transmission, Mobile Data Communications, and RF Microwave Amplifiers. The Telecommunications Transmission segment provides satellite earth station equipment and systems, over-the-horizon microwave systems, and forward error correction technology, which are used in various commercial and government applications, including backhaul of wireless and cellular traffic, broadcasting (including HDTV), IP-based communications traffic, long distance telephony, and secure defense applications. The Mobile Data Communications segment provides mobile satellite transceivers, and computers and satellite earth station network gateways and associated installation, training, and maintenance services; supplies and operates satellite packet data networks, including arranging and providing satellite capacity; and offers microsatellites and related components. The RF Microwave Amplifiers segment designs, develops, manufactures, and markets satellite earth station traveling wave tube amplifiers (TWTA) and broadband amplifiers. Its amplifiers are used in broadcast and broadband satellite communication; defense applications, such as telecommunications systems and electronic warfare systems; and commercial applications comprising oncology treatment systems, as well as to amplify signals carrying voice, video, or data for air-to-satellite-to-ground communications. The company serves satellite systems integrators, wireless and other communication service providers, broadcasters, defense contractors, military, governments, and oil companies. Comtech markets its products through independent representatives and value-added resellers. The company was founded in 1967 and is headquartered in Melville, New York.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

4Q24 Results. Revenue totaled $126.2 million, down sequentially and down from $148.8 million in 4Q23. We were at $130 million. Gross margin fell to 21.5% from 32.6% a year ago and was below our 30.8% estimate. Adjusted EBITDA was $0.3 million versus $18.9 million in 4Q23. Driven by $64 million of impairment charges, Comtech reported a 4Q24 net loss of $100.6 million, or a loss of $3.48/sh versus a loss of $5.3 million, or $0.19/sh in 4Q23.

Going Concern Still. Although we were hopeful the “Going Concern” designation would go away following the refinancing, it remains. According to the 10-K, “the Company has suffered recurring losses and negative cash outflows from operations, and may be unable to maintain compliance with financial covenants required by its credit agreement that raise substantial doubt about its ability to continue as a going concern.”


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Century Lithium Corp. (CYDVF) – Focus and Execution


Monday, November 04, 2024

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Lithium carbonate production at the pilot plant. Century Lithium has successfully produced battery-quality lithium carbonate at its Angel Island lithium project pilot plant and demonstrated it has an end-to-end process to produce lithium carbonate. The pilot plant utilizes the Company’s patent-pending process for chloride leaching combined with direct lithium extraction (DLE). Management is now focused on process optimization to reduce the project’s estimated capital and operating costs, along with advancing environmental studies, permitting, and project funding.

Progress on the environmental and permitting front. Century Lithium has completed a draft hydrological model and a draft Plan of Operations Additionally, Century has identified potential alternative locations for water supply closer to the project within its water rights permit to optimize resource usage.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Aurania Resources (AUIAF) – Setting Up for the 2025 Drilling Program


Monday, November 04, 2024

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Kuri-Yawi geophysical survey. Aurania commenced an induced polarization (IP) geophysical survey over its Kuri-Yawi gold target where the discovery of numerous sinters in 2018 revealed the area to be highly prospective for epithermal gold mineralization. Kuri-Yawi is the most advanced epithermal target at the company’s Lost Cities-Cutucu project in southeastern Ecuador and may represent the quickest path for a successful outcome based on work that has already been completed, along with easy access. In 2020 and 2021, nine scout holes were drilled that indicated a vector to mineralization toward the northeast which is the focus of the IP survey.


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

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

ACCO Brands (ACCO) – 3Q Post Call Commentary


Monday, November 04, 2024

ACCO Brands Corporation is one of the world’s largest designers, marketers and manufacturers of branded academic, consumer and business products. Our widely recognized brands include AT-A-GLANCE®, Esselte®, Five Star®, GBC®, Kensington®, Leitz®, Mead®, PowerA®, Quartet®, Rapid®, Rexel®, Swingline®, Tilibra®, and many others. Our products are sold in more than 100 countries around the world. More information about ACCO Brands, the Home of Great Brands Built by Great People, can be found at www.accobrands.com.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Green Shoots. In the third quarter, ACCO experienced growth across each of its segments. This was the second consecutive quarter of growth in computer accessories, which can be attributed to an improving demand environment as well as new product launches in gaming accessories. Growth was fueled by the successful rollout of new products as well as international expansion efforts.

Cash Flow. Following the historic pattern, ACCO generated significant cash flow in the quarter. CFFO in the quarter totaled $95.5 million, with CFFO for the nine month period totaling $96 million. On a year-to-date basis, CFFO is up $25 million. Free cash flow for the quarter totaled $89 million and is $87 million year-to-date. Free cash flow is up $26 million from the same period last year, reflecting improved working capital. Management continues to project full year free to be approximately $130 million.


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

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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Treasury Yields Drop Ahead of Election and Fed Decision

Key Points:
– U.S. Treasury yields declined as investors shifted to safer assets amid election and Fed uncertainty.
– Polls show Kamala Harris and Donald Trump in a dead heat, raising concerns about congressional control and potential policy impacts.
– A quarter-point rate cut is widely expected from the Federal Reserve this week, aimed at stimulating economic growth.

US Treasury yields fell on Monday as investors braced for a high-stakes week, with the upcoming U.S. presidential election and a key Federal Reserve rate decision poised to influence the economy and markets. The 10-year Treasury yield dropped nine basis points to 4.27%, while the 2-year yield decreased by over six basis points to 4.14%. These declines come as investors shift focus to safer assets amid election uncertainty and expected economic shifts. Yields, which move inversely to bond prices, reflected some caution as traders weigh potential election outcomes and their economic implications.

Polls indicate a tight race between Vice President Kamala Harris and former President Donald Trump, with NBC News showing the candidates locked at 49% each. Investors are particularly attentive to which party will control Congress, as this could dictate future policy moves, ranging from government spending to tax reforms. A split Congress would likely mean legislative gridlock, whereas a unified government might lead to significant policy changes. The election results could potentially impact stock markets, which experienced a volatile Monday, with the Dow Jones Industrial Average falling by 225 points or 0.5%, and both the S&P 500 and Nasdaq dipping by 0.2%.

In addition to the election, the Federal Reserve’s policy meeting on Thursday could mark another pivotal moment for markets. Analysts widely anticipate a quarter-point rate cut following the Fed’s recent 50 basis point cut in September. Traders are pricing in a 99% probability of this move, as tracked by CME Group’s FedWatch Tool. A rate cut could reduce borrowing costs and stimulate economic growth, potentially offsetting some of the anticipated volatility tied to the election.

Also weighing on markets were economic data points, with September factory orders down 0.5% in line with expectations. The Purchasing Managers Index (PMI) is due on Tuesday, and these indicators may provide additional insight into the economy’s current health as markets prepare for Fed Chair Jerome Powell’s comments on Thursday. Analysts suggest Powell’s statements could hint at the Fed’s future outlook for rates, as the central bank navigates a gradually slowing economy.

The shift towards Treasurys reflects a defensive stance by investors seeking stability amid looming uncertainties. Michael Zezas, a strategist at Morgan Stanley, suggested patience will be crucial for investors as they navigate potential market noise surrounding the election. The Treasury market’s reaction indicates some investors are bracing for turbulence in stocks if the election results lead to unexpected outcomes. The safe-haven nature of U.S. bonds offers a buffer for investors looking to mitigate risk in a potentially volatile environment.

Adding to market dynamics, Nvidia shares climbed 2% on Monday after it was announced the company would replace Intel in the Dow Jones Industrial Average, a change reflecting Nvidia’s year-to-date rise of 178% as it capitalizes on the AI sector. This development underscores a broader trend where technology and AI stocks remain central to market sentiment.

As election day approaches, financial markets are set to respond not only to the presidential outcome but also to shifts in Congress. With the Fed’s decision and further economic indicators expected this week, both equities and bond markets may experience heightened volatility, particularly if post-election policy signals lead to significant shifts in fiscal or monetary policy.

Release – Tonix Pharmaceuticals Presented Data on Potential Mpox Vaccine TNX-801 at World Vaccine Congress-Europe 2024

Research News and Market Data on TNXP

November 01, 2024 7:00am EDT Download as PDF

New data show tolerability and no evidence of spreading to blood or tissues even at high doses of Tonix’s attenuated live-virus, minimally replicating vaccine candidate TNX-801 in immunocompromised animals

TNX-801, has characteristics that align closely with the World Health Organization’s (WHO) preferred target product profile (TPP) criteria for mpox vaccines

WHO-declared public health emergency of international concern (PHEIC)1-4: Mpox cases of the new clade Ib mpox detected in Sweden, Thailand, Singapore, India, Germany and England

TNX-801 vaccination demonstrated efficacy in protecting animals from lethal challenge with clade I monkeypox and is in development as an mpox vaccine

CHATHAM, N.J., Nov. 01, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company with marketed products and a pipeline of development candidates, presented data in an oral presentation at the World Vaccine Congress-Europe 2024, held October 28-31, 2024 in Barcelona, Spain. A copy of the Company’s presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference.

The presentation titled, “A Novel, Single-dose, Live, Attenuated, Minimally Replicating Mpox Vaccine”, highlighted positive preclinical efficacy data, demonstrating tolerability in immunocompromised animals and showed that TNX-801 is unable to spread in blood or tissues in these animals, even at an approximately 100-fold higher dose than 20th century vaccinia vaccines.

TNX-801 is an attenuated live-virus vaccine based on synthesized horsepox that has been shown to provide single-dose immune protection against a monkeypox challenge with better tolerability than 20th century vaccinia live-virus vaccines in animals. TNX-801 has previously been shown to protect animals against lethal challenge with intratracheal clade I monkeypox virus.After a single dose vaccination, TNX-801 prevented clinical disease and lesions and also decreased shedding in the mouth and lungs of animals challenged with clade I monkeypox.1 These findings are consistent with TNX-801 inducing mucosal immunity and suggest TNX-801 has the ability to block forward transmission. An outbreak of clade I mpox has recently been declared a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO).2,3 Starting from an outbreak in the Democratic Republic of the Congo, clade I mpox has spread to sixteen Central African Countries and cases have been reported in Sweden, Thailand, Singapore, India, Germany and England. According to the U.S. Centers for Disease Control and Prevention (CDC), and other experts, there is a significant risk that clade I strain may appear in the U.S.4

“Data continue to support TNX-801’s strong tolerability and efficacy profiles by continually displaying protective immunity to animals with single-dose administration,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “Synthetic biology is an important technology for vaccine development as viral diseases continue to rapidly evolve. The new data demonstrate that TNX-801 is highly attenuated relative to 20th century vaccinia vaccines in immunocompromised animals.With TNX-801’s target profile, favorable shipping and storing requirements and our manufacturing collaboration agreements, we believe TNX-801 is in a strong position to make an impact towards preventing mpox and control mpox epidemics.”

In September 2024, Tonix announced that the World Health Organization’s (WHO’s) preferred target product profile (TPP), released at the WHO sponsored Mpox Research and Innovation Scientific Conference, aligns with the characteristics of TNX-801. Key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment, and stability at ambient temperature. Other potential beneficial characteristics include the ability to limit forward transmission, use in case-contact vaccination strategies and suitability for use in immunocompromised individuals.  

In August 2024, Tonix announced a collaboration with Bilthoven Biologics (Bbio) to develop GMP manufacturing processes for its mpox vaccine. Bbio is part of the world’s largest vaccine manufacturer, the Cyrus Poonawalla Group, which also includes the Serum Institute of India.

About TNX-801*
TNX-801 is a live replicating attenuated vaccine based on horsepox that is believed to provide immune protection with better tolerability than 20th century vaccinia viruses. As previously disclosed, TNX-801 protected animals against lethal challenge with intratracheal clade I monkeypox virus.1 After a single dose vaccination, TNX-801 prevented clinical disease and lesions and also decreased shedding in the mouth and lungs of non-human primates.1 The Findings are consistent with mucosal immunity and suggest the ability to block forward transmission, similar to Dr. Edward Jenner’s vaccinia vaccine, which eradicated smallpox and kept mpox out of the human population. On August 26, 2024, Tonix announced a collaboration to develop GMP manufacturing processes for its mpox vaccine with Bilthoven Biologics (Bbio), part of the world’s largest vaccine manufacturer, the Cyrus Poonawalla Group, which also includes the Serum Institute of India.

On the horsepox platform, Tonix is developing TNX-1800 (horsepox expressing SARS-CoV-2 spike protein) for protecting against COVID-19. TNX-1800 is an engineered version of horsepox that expresses the spike protein of SARS-CoV-2. In preclinical studies of TNX-1800 highlighted in the presentation, TNX-1800 was tested for immunogenicity and efficacy of TNX-1800 in nonhuman primates following a SARS CoV-2 challenge. 6,7 TNX-1800 vaccination results in a neutralizing antibody response that was associated with significant reduction in virus replication/shedding in the respiratory tract and tolerability. 2,3 TNX-1800 was selected by the NIH’s, Project NextGen for inclusion in clinical trials as part of a select group of next generation COVID-19 vaccine candidates with the intent to identify promising vaccine platforms. NIH plans to conduct a Phase 1 trial of TNX-1800 and cover the full cost of the study, while Tonix provides the vaccine candidate.

About Mpox*
On August 14, 2024, the WHO determined that the upsurge of mpox in a growing number of countries in Africa constitutes a public health emergency of international concern, the second such declaration in the past two years called in response to an mpox outbreak. The current outbreak was caused by clade I monkeypox virus, while the 2022 outbreak was clade II monkeypox virus. The global mpox outbreak, which commenced in 2022 has affected over 90,000 persons in countries where mpox had previously not been endemic, including Europe and the US. The spread of clade IIb strain mpox in 2022 underscores the pandemic potential of mpox. Unlike clade IIb mpox, the clade I strain of mpox appears to be spreading to countries neighboring the Democratic Republic of the Congo. According to the U.S. Centers for Disease Control and Prevention (CDC), and other experts, there is a significant risk that the deadlier clade I strain may appear in the U.S.4

Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to progress TNX-102 SL, a product candidate for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and its development is supported by a grant from the U.S. National Institude of Drug Abuse and Addiction. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*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. All other marks are property of their respective owners.

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

1Noyce RS, et al. Viruses. 2023 Jan 26;15(2):356. Doi: 10.3390/v15020356. PMID: 36851570; PMCID: PMC9965234
2WHO Press Release August 14, 2024. “WHO Director-General declares mpox outbrfeak a public health emergency of international concern”. URL: www.who.int/news/item/14-08-2024-who-director-general-declares-mpox-outbreak-a-public-health-emergency-of-international-concern (accessed 8-15-24)
3McQuiston JH, et al. U.S. Preparedness and Response to Increasing Clade I Mpox Cases in the Democratic Republic of the Congo. 2024, MMWR Morbi Mortal Wkly Rep: United States. p. 435-440
4CDC. 2022-2023 Mpox: US Map and Case Count.
5Trefry, SV et al. bioRxiv 2023.10.25.564033; doi: https://doi.org/10.1101/2023.10.25.564033
6Awasthi M et al Vaccines (Basel). 2023 11(11):1682. doi: 10.3390/vaccines11111682.PMID: 38006014
7Awasthi M, et al. Viruses. 2023 15(10):2131. doi: 10.3390/v15102131. PMID: 37896908; PMCID: PMC10612059.

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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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 Healthcare
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released November 1, 2024

Release – IP Survey Commences at Aurania’s Kuri-Yawi Gold Target in Ecuador

Research News and Market Data on AUIAF

Toronto, Ontario–(Newsfile Corp. – November 1, 2024) – Aurania Resources Ltd. (TSXV: ARU) (OTCQB: AUIAF) (FSE: 20Q) (“Aurania” or the “Company”) announces the start of the induced polarization (IP) geophysical survey at its Kuri-Yawi project in southeastern Ecuador. The survey is being carried out by the geophysics company GexplOre, which has extensive experience developing this technique within the Amazon rainforest. The geophysicists have arrived in the field last week following the completion of the line-cutting preparation work.

Kuri-Yawi is the most advanced epithermal target in the Company’s Cutucu project. The discovery of numerous sinters by the Aurania team in 2018 highlighted the area as highly prospective for epithermal gold mineralization. Extensive fieldwork subsequently conducted in the area, including geology, soil geochemistry and a Mobile MagnetoTellurics (MobileMT) airborne survey led to the drilling of nine scout holes during 2020 and 2021 to investigate the soil anomalies at depth. The results of the program indicated a vector to mineralization toward the northeast, the subject area of the current IP survey. Subsequent prospecting in this area discovered thallium-rich chalcedony veins (see Figure 1). Importantly, thallium is a volatile element often present in the upper parts of epithermal deposits. As well, TerraSpec infrared analyses of the alteration minerals in this area show typical epithermal chlorite-smectite-illite zonation towards the vein zone. The presence of these minerals suggests an intense hydrothermal alteration in the center of an epithermal system, which is interpreted to be responsible for the demagnetization of rocks observed in the area and also shown on the 2017 magnetic airborne survey (see Figure 2).

The IP survey is designed to identify deep conductors that could correspond to gold mineralization, and to target drill holes for the planned program in 2025. The IP survey is expected to be completed by mid-December 2024, with results expected in early 2025 following a review and interpretation of the data.



Figure 1: Alteration zonation by TerraSpec survey on the outcrop and thallium results from outcrop at Kuri Yawi.

To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2477/228557_042c330914c91bcc_001full.jpg



Figure 2: Magnetic airborne anomalies (blue areas indicate low magnetic conductivity and warm colours such as red-pink are highly magnetic) and thallium results on outcrop at Kuri Yawi.

To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2477/228557_042c330914c91bcc_002full.jpg

Sample Analysis & Quality Assurance / Quality Control (“QAQC”)

Laboratories: The samples were prepared for analysis at ALS Global’s (“ALS”) lab in Quito, or at MS Analytical (“MSA”) in Cuenca, Ecuador. Analysis by ALS was done in Lima, Peru, and MSA conducted their analyses in Vancouver, Canada.

Sample preparation: Rock samples were jaw-crushed to 10 mesh (crushed material passes through a mesh with apertures of 2 millimetres (“mm”)), from which a one-kilogram sub-sample was taken. The sub-sample was crushed to a grain size of 0.075mm and a 200g split was set aside for analysis.

Analytical procedure: A 0.5g split of the -0.075mm fraction of rock samples underwent digestion by four-acids, and the liquid was analyzed for 48 elements by ICP-MS. Gold was analyzed by fire assay with an ICP-AES finish.

QAQC: Aurania personnel inserted a certified standard pulp sample, alternating with a field blank, at approximate 20 sample intervals in all sample batches. Aurania’s analysis of results from its independent QAQC samples showed the batches reported on above, lie within acceptable limits. In addition, the labs reported that the analyses had passed their internal QAQC tests.

Qualified Persons:

The geological information contained in this news release has been verified and approved by Aurania’s VP Exploration, Mr. Jean-Paul Pallier, MSc. Mr. Pallier is a designated EurGeol by the European Federation of Geologists and a Qualified Person as defined by National Instrument 43-101, Standards of Disclosure for Mineral Projects of the Canadian Securities Administrators.

About Aurania

Aurania is a mineral exploration company engaged in the identification, evaluation, acquisition, and exploration of mineral property interests, with a focus on precious metals and copper in South America. Its flagship asset, The Lost Cities – Cutucú Project, is located in the Jurassic Metallogenic Belt in the eastern foothills of the Andes mountain range of southeastern Ecuador.

Information on Aurania and technical reports are available at www.aurania.com and www.sedarplus.ca, as well as on Facebook at https://www.facebook.com/auranialtd/, Twitter at https://twitter.com/auranialtd, and LinkedIn at https://www.linkedin.com/company/aurania-resources-ltd-.

For further information, please contact:

Carolyn Muir
VP Corporate Development & Investor Relations
Aurania Resources Ltd.
(416) 367-3200
carolyn.muir@aurania.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 release.

Forward-Looking Statements

This news release contains forward-looking information as such term is defined in applicable securities laws, which relate to future events or future performance and reflect management’s current expectations and assumptions. The forward-looking information includes Aurania’s objectives, goals or future plans, statements, exploration results, potential mineralization, the corporation’s portfolio, treasury, management team and enhanced capital markets profile, the estimation of mineral resources, exploration, timing of the commencement of operations, the Company’s teams being on track ahead of any drill program, the commencement of any drill program and estimates of market conditions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to Aurania, including the assumption that, there will be no material adverse change in metal prices, all necessary consents, licenses, permits and approvals will be obtained, including various local government licenses and the market. Investors are cautioned that these forward-looking statements are neither promises nor guarantees and are subject to risks and uncertainties that may cause future results to differ materially from those expected. Risk factors that could cause actual results to differ materially from the results expressed or implied by the forward-looking information include, among other things: commodity prices, supply chain disruptions, restrictions on labour and workplace attendance and local and international travel; a failure to obtain or delays in obtaining the required regulatory licenses, permits, approvals and consents; an inability to access financing as needed; a general economic downturn, a volatile stock price, labour strikes, political unrest, changes in the mining regulatory regime governing Aurania; a failure to comply with environmental regulations; a weakening of market and industry reliance on precious metals and base metals; and those risks set out in the Company’s public documents filed on SEDAR+. Aurania cautions the reader that the above list of risk factors is not exhaustive. Although the Company believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information, which only applies as of the date of this news release, and no assurance can be given that such events will occur in the disclosed time frames or at all. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, other than as required by law.

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SOURCE: Aurania Resources Ltd.