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NobleCon20 Investor / Attendee Registration Information

Posted on by cpatches

Investor / Attendee registration for NobleCon20 – Noble Capital Markets’ 20th Annual Emerging Growth Equity Conference – is now open!

Your paid registration includes access to all NobleCon20 events, including company presentations, scheduled 1×1 meetings with corporate executives (for qualified investors only), opening panels on both days, the headlining event featuring 2 of the original “Sharks” from ABC’s Shark Tank, and the Tuesday evening “After” networking hangar party. Registration also includes lunch on both days of the conference.

Investor / Attendee registration for NobleCon20 is $399 – As a Channelchek member you are entitled to a $250 discount – simply enter code CCMEMBERDISC at checkout.

Register Now

Also Available: VIP “Shark” Package – Exclusive Seating and Meet & Greet

World famous investors and stars of the ABC hit series Shark Tank will hit the NobleCon stage for a first – following a moderated fireside chat, venture capitalist “Mr. Wonderful,” Kevin O’Leary, information tech mogul Robert Herjavec, and FUBU founder Daymond John will travel down “Alligator Alley” to adjudicate a selection of pitches from the business community and Florida Atlantic students and alumni. This is your opportunity for best-in-the-house seating in the auditorium (seats 2400) and an EXCLUSIVE MEET & GREET / PHOTO OP with the “Sharks,” immediately following the stage event. Strictly limited to 100. $750 per person.

Release – ZyVersa Therapeutics Selects Obesity and Related Metabolic Complications as Lead Indication for Inflammasome ASC Inhibitor IC 100

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jul 25, 2024

PDF Version

WESTON, Fla., July 25, 2024 (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 that obesity and its related metabolic complications has been selected as the lead indication for Inflammasome ASC Inhibitor IC 100.

“Obesity, a well-established risk factor for an array of different metabolic disorders, including insulin resistance, type 2 Diabetes, hypertension, cardiovascular disease, and cancer, has reached pandemic proportions, affecting up to two-thirds of the adult population in developed countries,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “Published research demonstrating that inflammasome activation in fat tissue triggers cell death and systemic release of proinflammatory IL-1β, and ASC specks, which can perpetuate and spread inflammation leading to metabolic disturbances associated with obesity provides support for Inflammasome ASC Inhibitor IC 100 as a potential therapeutic option. We are excited about progressing our development program in this area of high unmet needs.”

Following is the rationale behind selection of obesity and related metabolic complications, and an overview of the development program.

Why Obesity and Related Metabolic Complications as an Indication?

  • Large Growing Market: The global obesity drug market reached nearly $24 billion in 2023, more than a sevenfold growth in just three years, and it is forecasted by IQVIA t to reach up to $131 Billion by 2028 (24 – 27% CAGR).
  • Significant Health and Economic Impact: Obesity, which now affects over 40% of Americans (CDC), is associated with multiple chronic medical conditions, including type 2 diabetes, heart disease, and some forms of cancer, at an annual cost and economic impact exceeding 1.4 trillion in the United States including healthcare expenditures, loss of productivity (Milken Institute).
  • Need for Alternative Mechanisms of Action to Complement GLP-1 agonists: While GLIP-1 drugs deliver meaningful weight loss, improve glucose control, and help to mitigate cardiovascular disease, they do not address the chronic tissue inflammation observed in adipose tissue, liver, muscle, and pancreatic islet cells that has emerged as a key feature of obesity. This chronic tissue inflammation, termed, “immunometabolism,” leads to insulin resistance, beta cell dysfunction, and development of type 2 diabetes and long-term inflammatory complications including microvascular disease (retinopathy, nephropathy, and neuropathy), macrovascular disease (stroke, myocardial infarction, and peripheral arterial disease), heart failure, and nonalcoholic fatty liver disease. As such, anti-inflammatory drugs have potential to provide additional benefits in obesity management (Immunity. 2022 Jan 11;55(1):31-55).

Rationale for Inflammasome Inhibitors as a Treatment for Obesity and Related Metabolic Complications

Inflammasomes, which are activated by nutrients, such as glucose and free fatty acids, trigger activation and stimulation of downstream inflammatory pathways, leading to chronic inflammation in obesity (Front Endocrinol (Lausanne). 2023 Aug 31;14:1232171).

  1. Nutrient overload triggers inflammasome-induced inflammation in the brain’s hypothalamus, causing increased appetite and food intake, increasing the number and size of fat cells associated with weight gain and obesity.
  2. The fat cells become hypoxic, resulting in cell death and macrophage recruitment. This leads to inflammasome activation, death of inflamed cells, and systemic release of proinflammatory cytokines, such as IL-1β, and ASC specks, spreading inflammation throughout the body. If unresolved, sustained inflammation leads to the metabolic complications of obesity.

Why Inflammasome ASC Inhibitor IC 100?

  • Multiple types of inflammasomes, not just NLRP3, are activated in obesity and related metabolic complications (NLRP1, NLRP3, NLRC4, and AIM2). Because IC 100 targets the inflammasome ASC component, it inhibits each of these inflammasomes, including NLRP3, with potential to better attenuate the damaging inflammation associated with obesity and its complications (Immunology. 2021 Aug;163(4):348-362).
  • Inflammation is spread and perpetuated by systemic release of proinflammatory IL-1β and ASC specks during death of inflamed cells, leading to obesity-related complications. IC 100 disrupts the structure and function of ASC specks, thereby attenuating spread and perpetuation of inflammation (Transl Res. 2022 Jul 3:S1931-5244(22)00150-5).

ZyVersa believes that inflammasome ASC Inhibitor IC 100 administered concurrently with GLIP-1 agonists will lead to incremental weight loss, and more importantly, attenuate the chronic tissue inflammation not addressed by GLIP-1 agonists to reduce the long-term micro- and macrovascular inflammatory complications.

Inflammasome ASC Inhibitor IC 100 Development Plans for Obesity and Related Complications

  • IC 100’s preclinical program is nearing completion, with a planned Investigational New Drug (IND) submission Q4-2024, and Phase 1 clinical trial initiation shortly thereafter.
  • Preclinical scientific collaboration to assess IC 100 as a potential treatment for atherosclerosis, a common obesity-related metabolic complication, is expected to conclude H2-2024.
  • Preclinical scientific collaboration with University of Miami Miller School of Medicine to assess IC 100 as a potential treatment for obesity and metabolic syndrome is expected to begin H2-2024, with a second study looking at concomitant treatment with IC 100 and a GLIP-1 agonist to begin shortly thereafter.
  • ZyVersa has recruited six top-tiered experts in obesity and related metabolic complications for a scientific advisory board to guide clinical development plans for IC 100, which will be announced in the next few weeks.

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, and 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. The lead indication for IC 100 is obesity and its associated metabolic complications. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

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 inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux MediatorTM VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. 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, Media, and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Tech Giants’ Earnings Disappoint, Causing Stock Market Decline

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Nasdaq falls nearly 3% after disappointing earnings from Alphabet and Tesla
– Tech sector leads market decline, potentially signaling a shift in investor sentiment
– Economic data adds to concerns about U.S. economic health

The U.S. stock market experienced a significant downturn on Wednesday, primarily driven by underwhelming earnings reports from major technology companies. This event highlights the influential role these firms play in overall market performance.

The Nasdaq Composite, which is heavily weighted towards technology stocks, dropped by almost 3%, marking its largest single-day decline since late 2022. The broader S&P 500 index also fell by 1.7%, while the Dow Jones Industrial Average decreased by 0.8%.

Two key players in the tech sector, Alphabet (Google’s parent company) and Tesla, reported earnings that fell short of investor expectations. Alphabet’s shares declined despite beating overall revenue and profit forecasts, as YouTube advertising revenue underperformed. Tesla’s stock price fell more sharply, following weaker-than-anticipated results and a decrease in automotive revenue compared to the previous year.

The disappointing performance of these tech giants had a ripple effect across the sector. Other major technology companies, including Nvidia, Meta Platforms, and Microsoft, also saw their stock prices decline in sympathy.

It’s worth noting that these large technology companies have been the primary drivers of market gains this year. Their outsized influence means that when they underperform, it can have a significant impact on overall market indices.

Interestingly, while large-cap tech stocks struggled, smaller companies showed resilience. The Russell 2000 small-cap index has performed well this month, potentially indicating a shift in investor focus towards a broader range of stocks.

Adding to market concerns, recent economic data painted a mixed picture of the U.S. economy. A report showed manufacturing activity unexpectedly contracting, while new home sales came in below expectations. These indicators raised questions about the overall health of the economy.

However, it’s important to maintain perspective. Despite the disappointing results from some tech giants, the broader earnings season has started positively. Over 25% of S&P 500 companies have reported second-quarter earnings, with about 80% exceeding expectations.

For investors, particularly those new to the market, this event serves as a reminder of the importance of diversification. Relying too heavily on a small group of high-performing stocks can increase risk. It also demonstrates that even the most successful companies can face challenges.

As we move forward, market participants will be closely monitoring upcoming earnings reports and economic data. The next few weeks will be crucial in determining whether this is a temporary setback or the beginning of a more significant market shift.

In conclusion, while days like this can be unsettling, they are a normal part of market dynamics. Understanding these fluctuations and maintaining a balanced, long-term perspective is key to navigating the complexities of the stock market.

Release – The GEO Group Announces Extension of Exchange Offer

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on GEO

BOCA RATON, Fla.–(BUSINESS WIRE)–Jul. 17, 2024– The GEO Group (NYSE: GEO) (“GEO” or the “Company”) announced today that it has extended its offers to exchange (the “Exchange Offer”) (i) up to $650.0 million aggregate principal amount of registered 8.625% Senior Secured Notes due 2029 (the “Secured Exchange Notes”) for any and all of its $650.0 million aggregate principal amount of unregistered 8.625% Senior Secured Notes due 2029 that were issued in a private placement on April 18, 2024 (the “Secured Original Notes”), and (ii) up to $625.0 million aggregate principal amount of registered 10.250% Senior Notes due 2031 (the “Unsecured Exchange Notes” and, together with the Secured Exchange Notes, the “Exchange Notes”) for any and all of its $625.0 million aggregate principal amount of unregistered 10.250% Senior Notes due 2031 that were issued in a private placement on April 18, 2024 (the “Unsecured Original Notes” and, together with the Secured Original Notes, the “Original Notes”).

The Exchange Offer, which was previously scheduled to expire at 5:00 p.m., New York City time, on July 16, 2024, will now expire at 5:00 p.m., New York City time, on July 23, 2024, unless earlier terminated or extended by the Company (such date and time, including any extension, the “Expiration Date”). Any Original Notes tendered may be withdrawn at any time prior to the Expiration Date, but not thereafter (the “Withdrawal Deadline”). Except for the extension of the Expiration Date and Withdrawal Deadline, all other terms of the Exchange Offer remain in full force and effect.

As of 5:00 p.m., New York City time, on July 16, 2024, which was the previous expiration date for the Exchange Offer, the aggregate principal amount of the Original Notes validly tendered and not validly withdrawn, as advised by D.F. King & Co., Inc., the Exchange Agent for the Exchange Offer, was as set forth in the table below:

The terms and conditions of the Exchange Offer are described in the Prospectus, dated June 14, 2024 and the Prospectus Supplement, dated June 27, 2024, which forms a part of the Registration Statement on Form S-4 filed with the Securities and Exchange Commission on May 31, 2024 and declared effective on June 13, 2024 (the “Registration Statement”). The Expiration Date for the Exchange Offer is being extended to provide time for remaining outstanding Original Notes to be tendered for exchange. The Exchange Offer is not conditioned upon any minimum amount of Original Notes being tendered. Subject to applicable law, the Company may waive certain other conditions applicable to the Exchange Offer or extend, terminate or otherwise amend the Exchange Offer in its sole discretion.

This news release is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to participate in the Exchange Offer, nor shall there be any sale of the Exchange Notes or exchange of the Original Notes in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. The Exchange Offer is being made solely pursuant to the Registration Statement. Copies of the Registration Statement and related prospectus can be obtained without charge by visiting the SEC website at www.sec.gov; by contacting D.F. King & Co., Inc., 48 Wall Street, 22nd Floor, New York, NY 10005; by calling toll-free at (800) 848-3405; or by e-mail at geo@dfking.com.

About The GEO Group

The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 100 facilities totaling approximately 81,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.

Use of Forward-Looking Statements

This news release may contain “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements and any such forward-looking statements are qualified in their entirety by reference to the following cautionary statements. All forward-looking statements speak only as of the date of this news release and are based on current expectations and involve a number of assumptions, risks and uncertainties that could cause the actual results to differ materially from such forward-looking statements. Risks and uncertainties that could cause actual results to vary from current expectations and forward-looking statements contained in this press release include, but are not limited to, risk factors contained in GEO’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K, 10-Q, and 8-K reports. GEO disclaims any obligation to update or revise any forward-looking statements, except as required by law.

Pablo E. Paez (866) 301 4436
Executive Vice President, Corporate Relations

Source: The GEO Group, Inc.

Release – V2X to Announce Second Quarter 2024 Financial Results

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on VVX

MCLEAN, Va., July 16, 2024 /PRNewswire/ — V2X, Inc., (NYSE: VVX), a leading provider of global mission solutions, will report second quarter 2024 financial results on Tuesday, August 6, 2024, before market open. Senior management will conduct a conference call at 8:00 a.m. ET that same day.

U.S.-based participants may dial in to the conference call at 877-506-6380, while international participants may dial 412-542-4198. A live webcast of the conference call as well as an accompanying slide presentation will be available at https://app.webinar.net/Aba2LPOkBXe and on the Investors section of the V2X website at https://gov2x.com/.

A replay of the conference call will be posted on the V2X website shortly after completion of the call and will be available for one year. A telephonic replay will also be available through August 20, 2024, at 844-512-2921 (domestic) or 412-317-6671 (international) with passcode 10190283.

About V2X
V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.

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

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

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/v2x-to-announce-second-quarter-2024-financial-results-302198671.html

SOURCE V2X, Inc.

Release – Tonix Pharmaceuticals Announces Proposed Public Offering

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 08, 2024 5:00pm EDT

CHATHAM, N.J., July 08, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof). All of the securities to be sold in the offering are to be offered by Tonix. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying prospectus. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained, when available, from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

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

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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. Tonix also has product candidates in development in the areas of rare disease and infectious disease. 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.

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has 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.

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

Media Contact 
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released July 8, 2024

Lilly Expands Immunology Footprint with $3.2 Billion Morphic Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

Pharmaceutical giant Eli Lilly and Company (NYSE: LLY) announced on July 8, 2024, its plans to acquire Morphic Holding, Inc. (NASDAQ: MORF) for $3.2 billion, marking a significant expansion of its presence in the immunology space. This strategic move aims to enhance Lilly’s pipeline in inflammatory bowel disease (IBD) treatments and broaden its portfolio of oral integrin therapies.

Under the agreement, Lilly will pay $57 per share in cash for all outstanding Morphic shares, representing a substantial 79% premium over Morphic’s closing stock price on July 5, 2024. The transaction, approved by both companies’ boards of directors, is expected to close in the third quarter of 2024, pending customary closing conditions and regulatory approvals.

At the heart of this acquisition is Morphic’s lead program, MORF-057, a selective oral small molecule inhibitor of α4β7 integrin. This promising compound is currently undergoing multiple Phase 2 studies for the treatment of ulcerative colitis and Crohn’s disease, two prevalent forms of IBD. The oral nature of MORF-057 could offer significant advantages over existing injectable therapies, potentially improving patient compliance and quality of life.

Dr. Daniel Skovronsky, Chief Scientific Officer of Lilly and President of Lilly Research Laboratories, highlighted the potential impact of oral therapies in IBD treatment. “Oral therapies could open up new possibilities for earlier intervention in diseases like ulcerative colitis, and also provide the potential for combination therapy to help patients with more severe disease,” he stated. This acquisition underscores Lilly’s commitment to developing first-in-class molecules in gastroenterology, an area where the company has been making substantial investments.

The deal also brings Morphic’s preclinical pipeline into Lilly’s fold, including molecules targeting autoimmune diseases, pulmonary hypertensive diseases, fibrotic diseases, and cancer. This addition further diversifies Lilly’s research and development efforts, potentially opening new avenues for therapeutic breakthroughs.

For Morphic, this deal represents a validation of its Integrin Technology platform and years of research. Dr. Praveen Tipirneni, CEO of Morphic Therapeutic, expressed confidence in Lilly’s ability to maximize MORF-057’s potential. “Lilly brings unparalleled resources and commitment to the inflammation and immunology field,” he noted, adding that the acquisition could “unlock new possibilities in IBD treatment.”

The transaction comes amid rapid growth in the global IBD therapeutics market. With the increasing prevalence of IBD worldwide and the limitations of current treatments, there is a significant unmet need for novel, more effective therapies. Lilly’s acquisition of Morphic positions the company to potentially capture a larger share of this expanding market and address critical patient needs.

From a financial perspective, the $3.2 billion deal represents a significant investment for Lilly. The company will determine the accounting treatment of the transaction as either a business combination or an asset acquisition upon closing, which will impact how it’s reflected in Lilly’s financial results and guidance.

The acquisition has ignited interest across the pharmaceutical industry, with analysts speculating that it could trigger a wave of similar deals in the integrin therapy space. As large pharmaceutical companies seek to bolster their pipelines and secure promising assets in high-growth therapeutic areas, smaller biotechnology firms with innovative platforms may become increasingly attractive targets.

However, Lilly faces the challenge of successfully integrating Morphic’s team and technologies into its existing operations. The company’s ability to manage this integration smoothly will be crucial in realizing the full potential of this deal and translating it into tangible benefits for patients and shareholders alike.

Lilly’s acquisition of Morphic represents a strategic move to strengthen its position in the immunology market, particularly in IBD treatments. With the potential to bring novel oral therapies to patients and expand its research capabilities, this deal could have far-reaching implications for both Lilly and the broader landscape of IBD treatment. As the transaction progresses towards closing, industry observers and patients alike will be watching closely to see how Lilly leverages this significant investment to drive innovation and improve patient outcomes in the years to come.

Telecommunications Giant Nokia Expands Optical Network Presence with Infinera Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

In a strategic move to bolster its position in the optical network market, Finnish telecommunications behemoth Nokia has announced plans to acquire Infinera Corporation, a California-based optical networking equipment manufacturer. The deal, valued at $2.3 billion, marks a significant step in Nokia’s efforts to scale up its optical network capabilities and strengthen its foothold in North America.

The acquisition, announced on Thursday, sent ripples through the tech industry, with Infinera’s stock price surging by nearly 22% following the news. Under the terms of the agreement, Nokia will pay $6.65 per share for Infinera, representing a substantial 26.4% premium over the company’s closing price of $5.26 on the day of the announcement.

This move comes as telecommunications companies worldwide are racing to upgrade their network infrastructure to meet the growing demand for high-speed connectivity and data transmission. Optical networks, which use light to transmit data over fiber optic cables, are crucial for supporting the increasing bandwidth requirements of 5G networks, cloud computing, and emerging technologies like artificial intelligence and the Internet of Things.

Infinera, headquartered in San Jose, California, has built a reputation as a leading provider of optical semiconductors and networking equipment for both fixed-line and mobile telecommunications networks. The company’s expertise in this field is expected to complement Nokia’s existing portfolio and accelerate its growth in the optical networking sector.

The deal structure allows for flexibility in payment, with Nokia committing to pay at least 70% of the purchase price in cash. Infinera shareholders will have the option to receive up to 30% of the total consideration in the form of Nokia’s American Depositary Shares, providing an opportunity for investors to maintain a stake in the combined entity.

From a financial perspective, the acquisition is projected to be immediately accretive to Nokia’s comparable earnings per share in the first year after closing. Moreover, the Finnish company anticipates that the deal will contribute over 10% to its profits by 2027, underscoring the long-term strategic value of the acquisition.

The move is particularly significant for Nokia’s expansion plans in North America, a key market for telecommunications infrastructure. By integrating Infinera’s technology and customer base, Nokia aims to enhance its competitive edge against rivals in the region and capitalize on the ongoing investments in network upgrades and 5G rollouts.

Industry analysts view this acquisition as a clear signal of Nokia’s commitment to diversifying its product offerings and strengthening its position in critical growth areas. The optical networking market is expected to experience robust growth in the coming years, driven by the increasing demand for high-capacity data transmission in various sectors, including telecommunications, data centers, and enterprise networks.

As the telecommunications landscape continues to evolve rapidly, strategic acquisitions like this one are becoming increasingly common. Companies are seeking to consolidate their strengths, fill gaps in their technological capabilities, and expand their market reach through carefully planned mergers and acquisitions.

The Nokia-Infinera deal is subject to customary closing conditions, including regulatory approvals and shareholder consent. Both companies have expressed confidence in the transaction’s potential to create value for their respective stakeholders and contribute to the advancement of global telecommunications infrastructure.

As the industry awaits the completion of this significant acquisition, all eyes will be on Nokia to see how it leverages Infinera’s expertise to drive innovation and growth in the competitive optical networking market.

From Crypto to Computing: Bit Digital’s AI Pivot Pays Off Big

Posted on by slightbourne@noblecapitalmarkets.com

In a move that’s turning heads on Wall Street, Bit Digital (Nasdaq: BTBT) is doubling down on its artificial intelligence infrastructure play. The New York-based company, once primarily known for its cryptocurrency mining operations, has just inked a deal that could redefine its future – and potentially reshape the landscape of AI computing services.

On June 25, 2024, Bit Digital announced the expansion of a contract with a major high-performance computing customer. The numbers are eye-popping: an additional 2,048 GPUs, bringing the total to 4,096, with a contract value of approximately $275 million over three years. That’s $92 million annually, for those keeping score at home.

But what’s really intriguing here isn’t just the scale of the deal – it’s what it represents. Bit Digital is making a calculated pivot, leveraging its expertise in managing complex computing operations to carve out a niche in the booming AI infrastructure market. And they’re doing it with gusto.

The company isn’t just talking a big game; they’re putting their money where their mouth is. They’ve placed an order for 256 servers from Dell Technologies, packed with Nvidia’s coveted HGX H100 GPUs. These aren’t your run-of-the-mill graphics cards; they’re the cream of the crop for AI computations, and Bit Digital is betting big on their potential.

What’s particularly savvy about this move is how Bit Digital is financing it. They’re using a mix of cash, digital assets, and a sale-leaseback agreement for half of the new GPUs. This financial juggling act demonstrates a level of fiscal acumen that should pique the interest of potential investors. It’s a strategy that minimizes upfront capital requirements while maximizing potential returns – music to any investor’s ears.

But here’s where it gets really interesting: this deal puts Bit Digital tantalizingly close to its goal of a $100 million annualized revenue run-rate by the end of 2024. They’re now sitting at over 90% of that target. For a company that was once primarily focused on bitcoin mining, this represents a remarkable transformation.

CEO Sam Tabar’s comments suggest this is just the beginning. He’s talking about “robust growth trajectory” and “scaling even further as the year progresses.” It’s the kind of optimistic language that makes investors’ ears perk up, especially when it’s backed by concrete deals like this one.

Of course, it’s not all smooth sailing. The AI infrastructure market is heating up, with tech giants and startups alike vying for a piece of the pie. Bit Digital will need to leverage its first-mover advantage and continue to execute flawlessly to maintain its edge.

Investors keen on getting more details won’t have to wait long. Bit Digital is slated to present at the Noble Capital Markets Consumer/TMT Virtual Conference this week. It’s an opportunity to hear directly from the company’s leadership about their strategy and future prospects.

As the lines between cryptocurrency, blockchain, and AI continue to blur, companies like Bit Digital are positioning themselves at the intersection of these transformative technologies. Their ability to pivot from crypto mining to AI infrastructure demonstrates an agility that could serve them well in the fast-paced tech sector.

For investors, Bit Digital represents an intriguing proposition. It’s a company with roots in the volatile world of cryptocurrency that’s now making significant inroads into the AI boom. As the demand for AI computing resources continues to skyrocket, Bit Digital’s bold moves could position them as a key player in this burgeoning field.

While the risks inherent in such a rapidly evolving sector shouldn’t be overlooked, Bit Digital’s recent contract win and ambitious revenue targets suggest a company that’s not just adapting to change, but actively shaping it. As always, potential investors should do their due diligence, but for those looking to ride the AI wave, Bit Digital is certainly a company worth watching.

Economic Headwinds: Labor Market Softens and Housing Sector Cools

Posted on by slightbourne@noblecapitalmarkets.com

Recent economic reports suggest that the U.S. economy may be facing increasing headwinds, with signs of softening in both the labor market and housing sector. These indicators point to a moderation in economic activity for the second quarter of 2024, potentially setting the stage for a shift in Federal Reserve policy later this year.

The Labor Department reported that initial jobless claims for the week ended June 15 fell by 5,000 to a seasonally adjusted 238,000. While this represents a slight improvement from the previous week’s 10-month high, it only partially reverses the recent upward trend. More tellingly, the four-week moving average of claims, which smooths out weekly volatility, rose to 232,750 – the highest level since mid-September 2023.

Adding to concerns about the labor market, continuing unemployment claims edged up to 1.828 million for the week ending June 8, marking the highest level since January. This uptick in ongoing claims could indicate that laid-off workers are facing increased difficulties in finding new employment, a potential red flag for overall job market health.

The unemployment rate, which rose to 4.0% in May for the first time since January 2022, further underscores the gradual cooling of the labor market. While job growth did accelerate in May, some economists caution that this may overstate the true robustness of employment conditions.

Turning to the housing sector, the news is equally sobering. The Commerce Department reported that housing starts plummeted 5.5% in May to a seasonally adjusted annual rate of 1.277 million units – the lowest level since June 2020. This decline was even more pronounced in the critical single-family housing segment, which saw starts fall 5.2% to a rate of 982,000 units, the lowest since October 2023.

The slowdown in housing construction is mirrored by a drop in building permits, often seen as a leading indicator for future construction activity. Permits for new housing projects tumbled 3.8% in May, again reaching levels not seen since June 2020. This decline in both current and future building activity paints a concerning picture for the housing market’s near-term prospects.

Several factors appear to be contributing to the housing sector’s struggles. Mortgage rates have seen significant volatility, with the average 30-year fixed rate reaching a six-month high of 7.22% in early May before retreating slightly. These elevated borrowing costs are keeping many potential buyers on the sidelines, as noted by the National Association of Home Builders, which reported that homebuilder confidence hit a six-month low in June.

The combination of a softening labor market and a cooling housing sector has led some economists to revise their growth projections downward. Goldman Sachs, for instance, has pared back its GDP growth estimate for the second quarter to a 1.9% annualized rate, down from an earlier projection of 2.0%.

These economic indicators are likely to factor heavily into the Federal Reserve’s decision-making process in the coming months. Despite the Fed’s more hawkish stance at its recent meeting, where officials projected just one quarter-point rate cut for this year, financial markets are anticipating the possibility of multiple rate cuts. The latest data may bolster the case for monetary easing, with some economists now seeing the potential for an initial rate cut as early as September.

Many economists believe that the soft activity and labor market data reinforce expectations for the Fed to begin cutting interest rates in the coming months, with potential cuts in September and December being discussed.

While the U.S. economy continues to show resilience in many areas, the emerging signs of moderation in both the labor and housing markets suggest that the impact of higher interest rates is beginning to be felt more broadly. As we move into the second half of 2024, all eyes will be on incoming economic data and the Federal Reserve’s response to these evolving conditions. The delicate balance between managing inflation and supporting economic growth remains a key challenge for policymakers in the months ahead.

The confluence of a cooling job market and a struggling housing sector paints a picture of an economy at a crossroads. As these trends continue to develop, they will likely play a crucial role in shaping both economic policy and market expectations for the remainder of the year and beyond.

Trump Media’s Truth Social Faces Market Turmoil as Shares Plummet

Posted on by slightbourne@noblecapitalmarkets.com

The digital media landscape is witnessing a dramatic shakeup as Trump Media & Technology Group, the company behind the conservative social network Truth Social, experiences a sharp decline in its stock value. The Nasdaq-listed company, trading under the ticker DJT, has seen its shares plummet by over 40% since early June, opening at a mere $27 per share on Thursday. This downturn has sent shockwaves through the social media stock market, raising questions about the future of alternative platforms in an increasingly competitive digital ecosystem.

The sell-off intensified Thursday, with shares sinking as much as 15% shortly after the opening bell, continuing a trend that has wiped billions from the company’s market capitalization. This steep decline has had a profound impact on the paper wealth of former President Donald Trump, the majority stakeholder in the company. Trump’s 114,750,000 shares, once valued at over $5.6 billion in early June, have now plummeted to around $3.2 billion – a staggering loss of approximately $2.4 billion in less than a month.

The catalyst for this market turbulence appears to be rooted in recent legal developments. The company’s stock began its downward spiral on May 30, coinciding with a New York jury’s decision to convict the former president on 34 felony counts of falsifying business records. This legal setback has evidently shaken investor confidence, highlighting the potential risks associated with companies closely tied to controversial public figures.

Adding to the tumult, Trump Media recently reached a crucial milestone in its regulatory journey. The Securities and Exchange Commission (SEC) declared the company’s registration statement effective, a development that triggered significant market reaction. The stock fell nearly 10% during Tuesday’s trading session on more than double the average volume, followed by a further 17% plunge in after-hours trading following the announcement.

This SEC approval marks a pivotal moment for Trump Media, authorizing early investors to exercise warrants and allowing stockholders to publicly resell securities covered by the registration statement. While this development provides greater liquidity for existing shareholders, it also introduces the potential for increased selling pressure, which could further impact the stock’s performance.

The volatility surrounding Trump Media serves as a case study in the challenges faced by emerging social media platforms as they navigate the complex interplay of market forces, regulatory requirements, and public perception. As the digital advertising landscape continues to evolve, investors and industry observers are closely watching how alternative social networks like Truth Social can carve out their niche and sustain growth in a highly competitive market.

The unfolding situation at Trump Media also underscores the importance of diversification in investment portfolios, particularly when dealing with stocks tied to high-profile individuals or emerging technologies. As the company strives to weather this storm, its ability to adapt to changing market conditions and demonstrate sustainable user growth will be crucial in regaining investor confidence.

In the broader context of social media innovation and digital marketing trends, the Trump Media saga highlights the ongoing shifts in online engagement and content monetization strategies. As users increasingly seek out niche platforms that align with their values and interests, the success of companies like Trump Media may hinge on their ability to foster engaged communities while navigating the complex regulatory and financial landscapes of the modern digital economy.

As this story continues to develop, it will undoubtedly remain a focal point for those interested in the intersection of technology, politics, and finance, offering valuable insights into the future of social media entrepreneurship and the challenges of building sustainable digital platforms in today’s rapidly changing online environment.

Release – Tonix Pharmaceuticals Presented Poster of Tonmya™ for the Management of Fibromyalgia at the Annual European Congress of Rheumatology (EULAR) 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 17, 2024 8:00am EDT

Treatment with Tonmya™ (TNX-102 SL, sublingual cyclobenzaprine HCl) in Phase 3 RESILIENT study significantly reduced daily pain and demonstrated broad fibromyalgia symptom improvement, as demonstrated by significant improvement on the primary pain endpoint and on all six key secondary endpoints

RESILIENT was the second Phase 3 study to reach statistical significance on the primary endpoint

New Drug Application (NDA) submission to the FDA on track for the second half of 2024

CHATHAM, N.J., June 17, 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, presented data from a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2024, held June 12-15, 2024 at the Messe Wien Congress Center in Vienna, Austria. A copy of the Company’s poster presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

In the poster presentation titled, “Targeting Non-Restorative Sleep in Fibromyalgia with Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl) Significantly Improves Pain in RESILIENT, a Confirmatory Phase 3 Randomized Clinical Trial”, Tonyma met the pre-specified primary endpoint in the Phase 3 RESILIENT trial, significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia while also demonstrating broad syndromal improvement. Tonmya demonstrated statistically significant improvement in all six pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. Tonmya was well tolerated with an adverse event (AE) profile comparable to prior studies and no new safety signals observed.

In pre-specified exploratory analyses, Tonmya treatment also improved depressive symptoms measured by the Beck Depression Inventory and improved female sexual function by the Changes in Sexual Function Questionnaire in the RESILIENT trial.

“People suffering with fibromyalgia tend to struggle with daily activities, have impaired quality of life and are frequently disabled”, said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe the activity of Tonmya on pain, sleep quality, fatigue cognitive dysfunction, and depression are indicative of the broad-spectrum activity of Tonmya, suggesting Tonmya treats fibromyalgia at a syndromal level. We are excited by the prospect of offering this patient population its potential first new therapy option in more than a decade.”

Tonix remains on track to submit an NDA to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and is in Phase 2 development supported by a grant from the National institute of Drug Abuse. Tonix’s immunology development portfolio consists of 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. Tonix also has product candidates in development in the areas of rare disease and infectious disease. 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.

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has 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.

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

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released June 17, 2024

Homebuyers Face Ongoing Affordability Challenges Despite Slight Mortgage Rate Dip

Posted on by slightbourne@noblecapitalmarkets.com

The mortgage market has seen a slight reprieve this week, with average rates on a 30-year fixed mortgage dipping just below 7%. According to Freddie Mac, the average rate has decreased to 6.95% from 6.99% the previous week. However, for many prospective homebuyers, this minor drop may not be enough to make a significant difference in affordability.

Freddie Mac’s report on Thursday highlights a small but noteworthy dip in mortgage rates. A separate measure tracking daily averages by Mortgage News Daily shows fluctuations between 6.97% and 7.17% over the past week. Despite this slight decline, the rates remain relatively high compared to historical lows, creating challenges for budget-conscious homebuyers.

The Federal Reserve’s policies continue to play a crucial role in shaping mortgage rates. Recently, the Fed decided to hold the benchmark rates steady at 5.25% to 5.50%, signaling only one rate cut for the rest of the year. This decision suggests that any substantial decline in mortgage rates is unlikely in the near future. The Fed’s cautious approach indicates that significant rate drops might not occur until well into 2025.

A recent study indicates that a majority of homebuyers, particularly first-time buyers, need significantly lower rates before they feel confident returning to the market. Ralph McLaughlin, Realtor.com’s senior economist, emphasizes that for inventory-constrained buyers, current mortgage trends will likely maintain the “mortgage rate lock-in effect.” This effect, where homeowners are reluctant to sell and buy new homes at higher rates, is expected to persist until at least the end of the year.

The latest inflation data has shown signs of moderation, with the core Consumer Price Index (CPI) excluding food and energy costs, climbing just 0.2% monthly in May—the lowest since last June. Overall inflation has decelerated year-over-year compared to April. While this news initially caused a dip in mortgage rates, the Fed’s subsequent announcement to hold rates steady tempered this effect. The Fed now projects one rate cut for the rest of the year, a reduction from previous expectations.

Fannie Mae’s homebuyer sentiment survey from May reveals that only one in four Americans expect mortgage rates to decrease over the next 12 months. In contrast, more than 30% of respondents anticipate that rates will rise. This sentiment has led to a new low in consumer confidence, driven by the overall lack of purchase affordability.

Despite current challenges, there is a glimmer of hope on the horizon for homebuyers. Economists at Bank of America Global Research predict multiple rate cuts over the next 24 months—four in 2025 and two in 2026. These cuts, in increments of 25 basis points, could bring rates down to between 3.50% and 3.75% by 2026. This long-term outlook provides a potential path to more affordable mortgage rates, but significant declines in the short term remain unlikely.

Last week saw a brief surge in mortgage application volume, increasing by 16% according to the Mortgage Bankers Association. This surge was primarily driven by a short-lived drop in daily rates, which hovered near 7%. New mortgage applications increased by 9%, though they remain 12% lower than the same week last year. Refinancing activity also saw a notable increase of 28% week-over-week, particularly among VA borrowers who took advantage of the lower rates.

At the current average rate of 6.95%, a homebuyer would pay approximately $1,600 monthly on a $300,000 home with a 20% down payment, according to the Yahoo Finance mortgage calculator. This cost highlights the ongoing challenge of affordability for many potential buyers.

While the slight dip in mortgage rates below 7% offers a small reprieve for homebuyers, significant declines are still months away. The Federal Reserve’s cautious approach, coupled with persistent inflation concerns, suggests that substantial rate reductions are unlikely until 2025. Homebuyers must navigate these challenges with careful planning and realistic expectations, while keeping an eye on long-term trends that may eventually bring relief.