Category:

Release – ZyVersa Therapeutics Reports Second Quarter, 2024 Financial Results and Provides Business Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Aug 9, 2024

PDF Version

KEY HIGHLIGHTS

  • Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease on track to begin H2-2024.
  • Obesity with related metabolic complications selected as lead indication for Inflammasome ASC Inhibitor IC 100.
    • Supportive data from preclinical study in atherosclerosis, a common obesity-related metabolic complication, is expected to be available H2-2024.
  • IC 100 Investigational New Drug (IND) submission planned for Q4-2024, to be followed by initiation of a Phase 1 clinical trial in obesity with metabolic complications expected to begin Q1-2025.
  • Raised approximately $0.8 million from exercise of investor warrants.

WESTON, Fla., Aug. 09, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for the quarter ended June 30, 2024, and provides business update.

“We are pleased to announce that ZyVersa remains on track to achieve key development milestones over the next 3 quarters,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “Our Phase 2a clinical trial with Cholesterol Efflux Mediator™ VAR 200 in diabetic kidney disease is expected to enroll the first patient(s) within the next few months, with an initial data read-out around the end of the year. In preparation for the planned Q4-2024 IND submission and subsequent phase 1 trial for Inflammasome ASC Inhibitor, a lead indication has been selected, obesity with related metabolic complications. This selection was based on unmet needs and IC 100’s mechanism of action substantiated in its robust preclinical program. By inhibiting ASC, IC 100 targets all four inflammasome pathways associated with obesity and related metabolic complications. Importantly, IC 100 disrupts the structure and function of extracellular ASC specks which perpetuate and spread damaging inflammation leading to obesity-related metabolic complications. We believe our milestone achievement will be a key inflection point for ZyVersa that will drive shareholder value.” 

BUSINESS UPDATE

CHOLESTEROL EFFLUX MEDIATOR™ VAR 200 FOR RENAL DISEASE

  • Phase 2a clinical trial in diabetic kidney disease is on target to begin H2-2024.
    • Clinical trial agreements have been successfully negotiated with both sites
    • Clinical trial Site IRB submissions have been approved for both sites
    • Clinical product and lab kits are ready to ship
    • Site initiation visits are scheduled
    • Enrollment of first patient(s) is expected in the next few months

INFLAMMASOME ASC INHIBITOR IC 100 FOR INFLAMMATORY DISEASES

  • IND submission planned for Q4-2024, to be followed by initiation of a Phase 1 clinical trial in obese patients with metabolic complications expected to begin Q1-2025.
    • IC 100 preclinical study in obesity with associated metabolic complications planned to conclude by year’s end, with a second study evaluating concomitant treatment of IC 100 and a GLP-1 agonist to begin shortly thereafter
    • Supportive data read-out from preclinical study in atherosclerosis expected H2-2024
    • GLP toxicology studies scheduled to begin H2-2024
  • ZyVersa has recruited six top-tiered experts in obesity and related metabolic complications for a scientific advisory board, which will be announced in the next few weeks, to guide clinical development plans for IC 100.
  • Recently published preclinical study demonstrated that IC 100 attenuates retinal inflammation, abnormal retinal vascularization, and retinal thinning, leading to restored retinal function in an animal model of retinopathy of prematurity (ROP).
    • ROP is the sixth indication with preclinical data demonstrating that IC 100 attenuates pathogenic inflammasome signaling pathways resulting in reduced inflammation and improved histopathological and/or functional outcomes
    • The other indications are early Alzheimer’s disease, multiple sclerosis, acute respiratory distress syndrome, spinal cord injury, and traumatic brain injury
  • Recently published preclinical study supports the potential of plasma ASC levels as a biomarker for early stages of cognitive decline, reinforcing the role of inflammasome-induced inflammation in the development of neurodegenerative conditions such as Alzheimer’s and Parkinson’s diseases, and the potential of inhibiting ASC with IC 100 as a treatment option.

SECOND QUARTER FINANCIAL RESULTS

Net losses were approximately $2.8 million for the three months ended June 30, 2024, with an improvement of $75.7 million or 96.5% compared to a net loss of approximately $78.5 million, for the three months ended June 30, 2023. This large improvement is due primarily to no further impact from our one-time impairment in 2023 of in-process research and development and goodwill.

Based on its current operating plan, ZyVersa expects its cash of $0.1 million as of June 30, 2024, will be sufficient to fund its operating expenses and capital expenditure requirements on a month-to-month basis. ZyVersa will need additional financing to support its continuing operations and to meet its stated milestones. ZyVersa will seek to fund its operations and clinical activity through public or private equity or debt financings or other sources, which may include government grants, collaborations with third parties or outstanding warrant exercises.

Research and development expenses were $0.7 million for the three months ended June 30, 2024, a decrease of $0.5 million or 41.9% from $1.2 million for the three months ended June 30, 2023. The decrease is primarily attributable to a decrease of $0.4 million in the costs of manufacturing of IC 100 and a decrease in payroll expenses due to employee attrition of $0.1 million.

General and administrative expenses were $2.0 million for the three months ended June 30, 2024, a decrease of $1.9 million or 48.0% from the three months ended June 30, 2023. The decrease is primarily attributable to a one-time 2023 charge of $1.2 million for common stock granted to certain members of the SPAC merger sponsor in exchange for certain concessions to extend the duration of their holding period. Other reductions include professional fees, marketing costs, director and officer insurance totaling $0.6 million, and a $0.1 million decrease in stock-based compensation as a result of options becoming fully amortized in February 2024.

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 Mediator™ 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, IR Contact

Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641        

View full release HERE.

GoHealth, Inc. (GOCO) – Is there a Tailwind in the Forecast?

Posted on by slightbourne@noblecapitalmarkets.com


Friday, August 09, 2024

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

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

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

Q2 results below estimates. The company reported Q2 revenue and adj. EBITDA of $105.9 million and a loss of $12.3 million, respectively, below our estimates. Our revenue and adj. EBITDA estimates were $144.0 million and a loss of $6.3 million, respectively.

Preparing for AEP. The company has been testing Plan Fit Save, an initiative whereby it is compensated by health plan carriers for improving customer retention when GoHealth recommends consumers to keep their existing plans. We believe the combination Plan Fit Save, as well as the prospect for disruption to health plan benefits in the upcoming Annual Enrollment Period, could set the company up for a strong finish to the year.


Get the Full Report

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.

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. 

Graham Corp (GHM) – A Deeper Dive into 2Q24 Results and Updated Model

Posted on by slightbourne@noblecapitalmarkets.com


Friday, August 09, 2024

Graham Corporation designs, manufactures and sells critical equipment for the energy, defense and chemical/petrochemical industries. The Company designs and manufactures custom-engineered ejectors, vacuum pumping systems, surface condensers and vacuum systems. It is a nuclear code accredited fabrication and specialty machining company. It supplies components used inside reactor vessels and outside containment vessels of nuclear power facilities. Its equipment is found in applications, such as metal refining, pulp and paper processing, water heating, refrigeration, desalination, food processing, pharmaceutical, heating, ventilating and air conditioning. For the defense industry, its equipment is used in nuclear propulsion power systems for the United States Navy. The Company’s products are used in a range of industrial process applications in energy markets, including petroleum refining, defense, chemical and petrochemical processing, power generation/alternative energy and other.

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.

2Q24 Results. The improved top and bottom lines reflect Graham’s successful operating strategy, in our view. The first quarter can be characterized by solid growth, consistent improvement, and strengthened profitability. We also would note the expansion of Graham’s defense business has reduced the Company’s economic sensitivity.

New Orders. Graham’s Barber-Nichols segment reported the receipt of three new awards, totaling in excess of $65 million. An extension of work for the MK48 Mod 7 Heavyweight torpedo program, received in the first quarter; a new program for the Columbia-class submarine; and a contract to provide cryogenic recirculation pumps for space vehicles. We believe these awards demonstrate the Company’s capabilities to successfully compete in its key markets.


Get the Full Report

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.

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. 

Harte Hanks (HHS) – Investment In Sales Not Yet Kicking In Gear

Posted on by slightbourne@noblecapitalmarkets.com


Friday, August 09, 2024

Harte Hanks (NASDAQ: HHS) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract, and engage their customers. Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world’s premier brands including Bank of America, GlaxoSmithKline, Unilever, Pfizer, HBOMax, Volvo, Ford, FedEx, Midea, Sony, and IBM among others. Headquartered in Chelmsford, Massachusetts , Harte Hanks has over 2,500 employees in offices across the Americas, Europe and Asia Pacific .

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

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Mixed Q2 results. Revenues of $45.0 million was slightly below our $47.5 million estimate. In spite of the lighter than expected revenues, the company delivered on adj. EBITDA expectations at $3.6 million, reflecting benefits from its cost efficiency strategy developed last year. Figure #1 Q2 Results highlights the quarter versus our estimates. 

A healthy revenue indicator. Management indicated that its pipeline of business is building and ahead of last year, but that there is a long tail to convert to revenue. We believe that the company’s investment into building its sales infrastructure and culture, which began late last year, has yet to be converted into enhanced revenue. The hoped for impact of the investment may be pushed out a quarter or two.


Get the Full Report

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.

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. 

NN Inc (NNBR) – Reports Second Quarter Results

Posted on by slightbourne@noblecapitalmarkets.com


Friday, August 09, 2024

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.

2Q24. Net sales totaled $123 million, down 1.8% y-o-y. We were at $118 million. Adjusted EBITDA was $13.4 million, up from $10.5 million last year and above our $12.2 million estimate. The second quarter was the fourth consecutive quarter of improved y-o-y performance. NN reported an adjusted net loss of $0.02/sh, compared to an adjusted net loss of $0.08/sh in 2Q23. We were at an adjusted loss of $0.05/sh.

Transformation Program. NN is seeing the benefits of its transformation initiatives, which are yielding observable momentum across key focus areas of profitability enhancement, operational performance, and accelerated new business wins. Notably, on a trailing-twelve-month basis, NN has delivered adjusted EBITDA of  $49.2 million, an improvement of 28.7% y-o-y.


Get the Full Report

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.

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. 

Ocugen (OCGN) – 2Q24 Reported With Summary Of Progress In Clinical Trials

Posted on by slightbourne@noblecapitalmarkets.com


Friday, August 09, 2024

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Ocugen reported a 2Q24 loss of $10.3 million or $(0.04) per share. During the quarter, the first patient was treated in the Phase 3 liMeliGhT (pronounced “limelight”) trial for OCU400 in retinitis pigmentosa (RP). Separately, the Phase 1/2 OCU410 trial for geographic atrophy in dry AMD completed dosing of its third cohort and began Phase 2. Cash on June 30 was $15.7 million, excluding $32.6 million raised in a public offering on August 2. Based on our quarterly estimates, we project cash to last until 2H25 with about $40 million in cash at the end of 3Q24.

OCU400 Began The Phase 3 liMeliGht Trial and Expanded Access. During the quarter, the first patient in the Phase 3 liMeliGhT trial testing OCU400 in retinitis pigmentosa (RP) was treated. The trial has one arm testing OCU400 in patients that have the RHO mutation and another arm with any of several gene mutations associated with RP. Each arm will have 75 patients for a total target enrollment of 150 patients.


Get the Full Report

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.

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. 

Saga Communications (SGA) – Political A Big Swing Factor

Posted on by slightbourne@noblecapitalmarkets.com


Friday, August 09, 2024

Saga Communications, Inc. is a broadcast company whose business is primarily devoted to acquiring, developing and operating radio stations. Saga currently owns or operates broadcast properties in 27 markets, including 79 FM and 33 AM radio stations. Saga’s strategy is to operate top billing radio stations in mid sized markets, defined as markets ranked (by market revenues) from 20 to 200. Saga’s radio stations employ a myriad of programming formats, including Active Rock, Adult Album Alternative, Adult Contemporary, Country, Classic Country, Classic Hits, Classic Rock, Contemporary Hits Radio, News/Talk, Oldies and Urban Contemporary. In operating its stations, Saga concentrates on the development of strong decentralized local management, which is responsible for the day-to-day operations of the stations in their market area and is compensated based on their financial performance as well as other performance factors that are deemed to effect the long-term ability of the stations to achieve financial objectives. Saga began operations in 1986 and became a publicly traded company in December 1992. The stock trades on NASDAQ under the ticker symbol “SGA”.

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

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Delivers on expectations. The company reported Q2 revenue of $28.7 million and adj. EBITDA of $4.4 million, both of which were in line with our estimates of $28.8 million and $4.6 million, respectively as illustrated in Figure #1 Q2 Results. Notably, the revenue estimate was achieved in spite of weaker than expected Political advertising. 

Pacings appear weak. Management indicated that Q3 revenues are pacing down mid single digits, which, we believe, may be conservative given that there is limited visibility on Political advertising. The weak revenue outlook reflects, however, lackluster core advertising which appears to be impacted by the current macroeconomic headwinds.  


Get the Full Report

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.

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. 

Retail Investors Navigate Volatile Markets with Caution and Opportunism

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Retail investors remain net buyers during recent market volatility
– Tech stocks and Treasury ETFs attract individual investor interest
– Mixed signals emerge from different research reports and platforms

The recent turbulence in U.S. stock markets has put a spotlight on the behavior of retail investors, who have emerged as a significant force in shaping market dynamics. As major indexes experienced sharp swings, including a notable sell-off that saw declines of 2.6% to 3.4% in a single day, individual investors have demonstrated both resilience and adaptability. This article delves into the various strategies and trends observed among retail investors during this period of market volatility, drawing insights from multiple research reports and trading platforms. For investors seeking to navigate these complex markets, resources like Channelchek offer valuable research and analysis to inform investment decisions.

Vanda Research, a New York-based market analysis firm, reported that retail investors continued to be net buyers of popular tech stocks such as Nvidia, Intel, and Advanced Micro Devices during the market downturn. Marco Iachini, senior vice president of research at Vanda, noted that “There was no retail capitulation,” emphasizing the persistent “dip-buying spree” among individual investors.

This trend was further corroborated by data from Robinhood Markets, which saw a significant influx of new cash from retail clients. The popular trading platform received $1 billion in the first week of August, with half of that amount deposited during Monday’s sell-off alone. This surge in deposits far exceeded Robinhood’s second-quarter daily average of less than $350 million.

However, the picture is not uniformly bullish. A separate report from JP Morgan analysts suggested that retail investors were “aggressive net sellers” during the first hour of Monday’s trading session. This conflicting data highlights the complex and diverse nature of retail investor behavior during periods of market stress, underscoring the importance of comprehensive research platforms like Channelchek in providing investors with well-rounded insights.

Interestingly, as markets recovered on Tuesday and Wednesday, retail investors showed increased interest in the iShares 20+ Year Treasury Bond ETF. Vanda Research reported that by Thursday morning, this ETF had become the second-most-actively purchased security after Nvidia shares. This shift towards a traditionally safer asset class may indicate growing anxiety among individual investors about the stock market’s outlook.

Further evidence of a cautious approach comes from Alight Solutions, which tracks trading activity in approximately 2 million 401(k) retirement accounts. Rob Austin, head of research at Alight, noted that investors were actively moving assets out of stock funds and into money markets and fixed-income products. While the volume of these shifts was significant – about eight times the average – it represented only a small fraction (0.1%) of the $200 billion in assets tracked by the firm.

The divergent behaviors observed across different platforms and research reports underscore the complexity of retail investor sentiment in the current market environment. While many individual investors continue to see buying opportunities in market dips, particularly in the tech sector, others are beginning to hedge their bets by allocating funds to more conservative investments.

This nuanced approach reflects a growing sophistication among retail investors, who are increasingly able to navigate volatile markets with a combination of opportunism and risk management. As market uncertainties persist, driven by factors such as economic data, earnings reports, and global trade dynamics, the actions of retail investors will likely continue to play a significant role in shaping market trends.

For market observers and professional investors, understanding these retail investor behaviors has become increasingly crucial. The ability of individual investors to quickly mobilize capital and their growing influence on market dynamics make them a force that cannot be ignored in today’s financial landscape.

Algonquin Power & Utilities Corp. Pivots to Pure-Play Utility with $2.5B Renewable Energy Sale

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Algonquin (AQN) to sell renewable energy business to LS Power for up to $2.5 billion
– Transaction aims to transform AQN into a pure-play regulated utility
– Deal expected to close in Q4 2024 or Q1 2025, subject to regulatory approvals

Algonquin Power & Utilities Corp. (AQN) has announced a strategic move to reshape its business model, entering into a definitive agreement to sell its renewable energy business to LS Power for a total consideration of up to $2.5 billion. This transaction marks a significant milestone in AQN’s transformation into a pure-play regulated utility, aligning with the company’s objective to enhance long-term value for both customers and shareholders.

The deal, unanimously approved by AQN’s board of directors, involves the sale of the company’s renewable energy assets, excluding its hydro operations. The transaction structure includes $2.28 billion in cash at closing, subject to certain adjustments, and a potential additional $220 million through an earn-out agreement related to specific wind assets.

Chris Huskilson, CEO of AQN, expressed satisfaction with the outcome of what he described as a “highly competitive strategic sale process.” He emphasized that this transaction, coupled with the previously announced plan to support the sale of AQN’s Atlantica shares, delivers on the company’s strategy to optimize its regulated business activities, strengthen its balance sheet, and improve the quality of its earnings.

The renewable energy business being divested has been a significant part of AQN’s operations for over three decades. Huskilson acknowledged the hard work and dedication of the employees who contributed to building this “compelling and competitive business with scale and strong assets.”

From a financial perspective, AQN expects to receive estimated cash proceeds of approximately $1.6 billion after accounting for the repayment of construction financing, taxes, transaction fees, and other closing adjustments. This influx of capital is expected to play a crucial role in recapitalizing the company’s balance sheet and positioning it for future growth within the regulated utility sector.

The transaction is subject to customary closing conditions, including approvals from the U.S. Federal Energy Regulatory Commission and relevant competition authorities. AQN anticipates the deal will close either in the fourth quarter of 2024 or the first quarter of 2025.

This strategic divestment comes at a time when many energy companies are reevaluating their business models in response to changing market dynamics and regulatory environments. By focusing on its regulated utility operations, AQN aims to provide more predictable earnings and stable returns for investors, while continuing to deliver reliable energy and water solutions to its customer base of over one million connections, primarily in the United States and Canada.

As AQN transitions to a pure-play regulated utility, investors and industry observers will be watching closely to see how this strategic shift impacts the company’s financial performance and market position in the coming years. The move represents a significant change for a company that has long been known for its diversified portfolio of generation, transmission, and distribution assets.

With this transaction, Algonquin Power & Utilities Corp. is betting on the stability and predictability of regulated utility operations to drive its future growth and shareholder value. As the energy landscape continues to evolve, AQN’s strategic pivot may serve as a case study for other companies in the sector considering similar transformations.

Eli Lilly Soars as Diabetes and Weight Loss Drugs Fuel Blowout Results

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Eli Lilly reports blowout Q2 earnings and revenue, crushing analyst estimates
– Strong Mounjaro diabetes and Zepbound weight loss drug sales drive guidance hike
– Company boosts full-year revenue outlook by $3 billion, adjusts earnings higher

Eli Lilly, the pharmaceutical industry leader, has delivered a remarkable performance in the second quarter of 2024, with earnings and revenue results that have easily surpassed Wall Street’s expectations. The driving force behind the company’s stellar Q2 2024 financial figures was the skyrocketing demand for its blockbuster diabetes treatment Mounjaro and weight loss injection Zepbound.

Eli Lilly reported second-quarter earnings per share of $3.92, far exceeding the $2.60 expected by analysts. Revenue for the period came in at $11.30 billion, a 36% increase from the same quarter a year earlier and well above the $9.92 billion consensus estimate. This strong showing prompted the company to significantly raise its full-year revenue outlook, increasing the range by $3 billion to between $45.4 billion and $46.6 billion. Additionally, Eli Lilly hiked its adjusted earnings guidance for 2024 to $16.10 to $16.60 per share, up from the previous range of $13.50 to $14 per share.

The exceptional sales of Mounjaro and Zepbound were the primary drivers behind Eli Lilly’s blowout Q2 2024 results. Mounjaro, the company’s in-demand diabetes drug, generated $3.09 billion in revenue during the second quarter, more than tripling the sales it recorded a year earlier. Meanwhile, Zepbound, Eli Lilly’s weight loss injection, raked in $1.24 billion, significantly exceeding the $922.2 million that analysts had anticipated.

The surging demand for these incretin-based therapies has compelled Eli Lilly to rapidly scale up its production capabilities to meet market needs. The company has built six new manufacturing plants and hired thousands of additional workers to increase its output. CEO David Ricks stated that the company expects incretin drug production in the second half of 2024 to be 50% higher than it was during the same period last year, with further ramp-ups planned for 2025.

Eli Lilly’s ability to quickly adapt and expand its manufacturing capacity has been a key factor in its success. The company’s agility in addressing supply constraints and delivering a steady stream of its in-demand Mounjaro and Zepbound products has resonated with both healthcare providers and patients. As the market for incretin-based treatments continues to grow, Eli Lilly’s strategic investments in production and its relentless focus on meeting demand have positioned the company as a dominant player in the field of metabolic disorder therapies.

Looking ahead, Eli Lilly remains optimistic about the long-term prospects for its diabetes and weight loss drugs. The company is not only working to further increase its manufacturing capabilities but is also developing more convenient weight loss pills, which could help it capitalize on the skyrocketing demand for effective obesity treatments.

For investors, Eli Lilly’s stellar Q2 2024 performance and guidance hike underscore the company’s ability to navigate the evolving healthcare landscape and deliver consistent growth. As the pharmaceutical industry continues to evolve, Eli Lilly’s focus on innovation, agility, and meeting the needs of patients and healthcare providers has solidified its position as a leader in the field of metabolic disorder treatments.

Release – PDS Biotech Announces Abstract Accepted for Oral Presentation at 2024 ASTRO Annual Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

PRINCETON, N.J., Aug. 08, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that updated data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune® HPV (formerly PDS0101) with chemoradiation to treat locally advanced cervical cancer will be presented during an oral presentation at the 2024 ASTRO Annual Meeting being held in Washington, DC, and virtually September 29 through October 2, 2024.

Details of the presentation are as follows:

Date: Tuesday, October 1, 2024, 2:50-3:00 p.m. ET
Session title: SS 34 – GYN 2: Strategies and Innovations of Clinical Trials in Gynecologic Cancers
Presentation title: 298 – IMMUNOCERV Phase II Trial Combining the HPV-Specific T Cell Immunotherapy PDS0101 with Chemoradiation for Treatment of Locally Advanced Cervical Cancer
Presenting author: Adam Grippin, M.D., Ph.D., The University of Texas MD Anderson Cancer Center

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

For more information, please visit www.pdsbiotech.com.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com

Release – Ocugen Provides Business Update with Second Quarter 2024 Financial Results

Posted on by aweinsoff@channelchek.com

News Research and Market Data on OCGN

August 8, 2024

PDF Version

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

  • Actively dosing patients in OCU400 Phase 3 liMeliGhT clinical trial
  • OCU410 preliminary safety and efficacy data expected later this year
  • Expanded access program approved for OCU400
  • $32.6 million net cash from underwritten public offering of common stock

MALVERN, Pa., Aug. 08, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today reported second quarter 2024 financial results along with a business update.

“The first half of 2024 has been marked with significant accomplishments for our modifier gene therapy platform—including dosing patients in the OCU400 Phase 3 clinical trial for retinitis pigmentosa (RP) and progressing into Phase 2 of the OCU410 ArMaDa clinical trial for the treatment of geographic atrophy (GA),” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “These meaningful milestones bring us closer to providing a potential one-time therapy for life for patients living with RP (300,000 in the U.S. and Europe) and GA (2-3 million in the U.S. and Europe) who desperately need effective treatment options. Thanks to our Ocugen team for their tireless efforts to keep these and all our clinical trials on track.”

The OCU400 Phase 3 trial has a sample size of 150 participants: one arm has 75 participants with RHO gene mutations, and the other arm has 75 participants with mutations in any of several other genes associated with RP. The Luminance Dependent Navigation Assessment (LDNA) is the primary endpoint for the study. In this assessment, a participant navigates an obstacle course that constitutes a more sensitive and specific measurement of visual function than the mobility measurement used in previous Phase 3 clinical trials. The Phase 3 liMeliGhT trial will focus on the proportion of responders, in treated and untreated groups, who achieve an improvement of at least 2 Lux (light) levels from baseline in the study eyes. More than 60% of the intent-to-treat patients from the Phase 1/2 clinical trial, including patients with the RHO mutation, meet the responder criteria established for Phase 3. The Phase 3 mobility test responder rate for the only FDA-approved product to treat one mutation in RP was 52%. The Phase 3 trial is powered greater than 95% assuming a 50% responder rate.  

Recently, the FDA approved the OCU400 expanded access program (EAP) for the treatment of adult patients, aged 18 and older, with RP. This is the first ever gene therapy candidate to treat patients with RP, regardless of mutation, approved for an EAP and the EAP further supports the gene-agnostic mechanism of action for this novel modifier gene therapy.

Novel modifier gene therapy has the potential to address multiple inherited retinal diseases as well as multifactorial causes of blindness that affect millions of patients, like dry age-related macular degeneration (dAMD). OCU410 and OCU410ST aim to treat geographic atrophy secondary to dAMD and Stargardt disease, respectively. These modifier gene therapies leverage a nuclear hormone receptor gene called RORA (RAR-related orphan receptor A) as a potential one-time therapy for life with a single sub-retinal injection.

OCU410 is specifically designed to address multiple pathways implicated in the pathogenesis of dAMD and offers a distinct advantage over current treatment options that target only one pathway—the complement system—and require frequent intravitreal injections (about 6-12 doses per year), accompanied by various safety concerns, such as roughly 12% of patients progressing to wet AMD. OCU410 has the potential to regulate all four pathways related to disease progression—lipid metabolism, inflammation, oxidative stress, and the complement system—with a one-time sub-retinal injection.

OCU410ST has received an Orphan Drug Designation from the FDA for the treatment of Stargardt disease, which has no approved treatment and affects approximately 100,000 people in the U.S. and Europe combined. The third cohort of the clinical trial is currently receiving the high dose. OCU410ST has the potential to be the first one-time gene therapy for Stargardt disease.

Ocugen continues to pursue strategic partnerships that will drive long-term strategy, and most importantly, will help patients access these novel modifier gene therapies globally. During the 2024 BIO International Convention, Ocugen engaged with potential partners and pharmaceutical executives to explore opportunities for the Company’s dynamic pipeline.

“Ocugen’s inclusion in the Russell Index in June further bolsters the value of our pipeline and recognizes the Company’s robust growth strategy,” said Dr. Musunuri. “This ranking supports our efforts to enable long-term shareholder value, garner significant visibility for Ocugen within the investment community, and broaden our shareholder base. I look forward to the second half of 2024 as we continue to solidify Ocugen’s position as a biotechnology leader.”

Subsequent to June 30, 2024, the Company closed a public offering of common stock with net proceeds of $32.6 million—extending its expected cash runway into the third quarter of 2025. The offering was led by a large premier mutual fund, along with participation from leading life sciences investors.

Ophthalmic Gene Therapies—First-in-Class

OCU400 – Ocugen is actively dosing subjects in the OCU400 Phase 3 liMeliGhT trial for the treatment of RP. With dosing of the Phase 3 trial underway, OCU400 remains on track for the 2026 BLA and MAA approval targets.

OCU410 – In July 2024, Ocugen announced the completion of dosing in the third cohort of the OCU410 Phase 1/2 ArMaDa clinical trial for the treatment of GA. To date, nine patients with GA have been dosed in the Phase 1/2 clinical trial (with low, medium, and high doses). Phase 2 of the clinical trial has been initiated and will assess the safety and efficacy of OCU410 in a larger group of patients who will be randomized into either of two treatment groups (medium or high dose) or a control group.

OCU410ST – Currently dosing the high dose of OCU410ST in the dose-escalation phase of the study.

Regenerative Cell Therapies—First-in-class

NeoCart® – Ocugen intends to initiate the Phase 3 trial contingent on the availability of adequate funding.
Vaccines Portfolio—First-in-class

Inhaled Mucosal Vaccine Platform – NIAID plans to submit an IND to initiate the OCU500 (COVID-19) Phase 1 clinical trial this year. Ocugen is continuing discussions with relevant government agencies as well as strategic partners regarding funding for the development of the OCU510 and OCU520 platforms.

Ophthalmic Biologic Product

OCU200 – Ocugen continues to work with the FDA to lift the clinical hold.

Second Quarter 2024 Financial Results

  • Received $32.6 million net cash from underwritten public offering of common stock that closed on August 2, 2024.
  • The Company’s cash, cash equivalents, and restricted cash totaled $16.0 million as of June 30, 2024, compared to $39.5 million as of December 31, 2023. The Company had 257.4 million shares of common stock outstanding as of June 30, 2024.
  • Total operating expenses for the three months ended June 30, 2024 were $16.6 million and included research and development expenses of $8.9 million and general and administrative expenses of $7.7 million. This compares to total operating expenses for the three months ended June 30, 2023 of $24.0 million that included research and development expenses of $14.5 million and general and administrative expenses of $9.5 million.
  • Ocugen reported a $0.04 net loss per common share for the three months ended June 30, 2024 compared to a $0.10 net loss per common share for the three months ended June 30, 2023.

Conference Call and Webcast Details

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

Attendees are invited to participate on the call or webcast:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 7453742
Webcast: Available on the events section of the Ocugen investor site

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

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

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs; Ocugen’s financial condition and expected cash runway into the third quarter of 2025, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our annual and periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

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

View full release HERE.

Release – GoHealth Reports Second Quarter 2024 Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOCO

Aug 08, 2024 at 6:00 AM EDT

CHICAGO, Aug. 08, 2024 (GLOBE NEWSWIRE) — GoHealth, Inc. (NASDAQ: GOCO) (“GoHealth” or the “Company”), a leading health insurance marketplace and Medicare-focused digital health company, today announced financial results for the three and six months ended June 30, 2024.

Second Quarter Highlights

  • Second quarter 2024 net revenues of $105.9 million, a $36.9 million decrease compared to $142.8 million in the prior year period.
  • Second quarter 2024 Submissions of 152,394, a 6% decrease compared to 162,837 Submissions in the prior year period, driven by an increase in Submissions generated by GoHealth’s internal captive agents offset by a decrease in Submissions generated by our external GoPartner Solutions agents.
  • Second quarter 2024 net loss of $59.3 million, an improvement of $10.9 million compared to a net loss of $70.2 million in the prior year period.
  • Second quarter 2024 Adjusted EBITDA(1) of negative $12.3 million, a decrease of $13.1 million compared to positive $0.8 million in the prior year period.
  • Second quarter 2024 trailing twelve months (“TTM”) positive cash flow from operations was $53.8 million, a decrease of $32.1 million compared to TTM positive cash flow from operations of $85.9 million in the prior year period.

“We experienced a decline in net revenues to $105.9 million due to a 6% decrease in total Submissions. Submissions generated by our internal captive agents increased year-over-year, offset by a decline in Submissions generated by our external GoPartner Solutions, or GPS, agents,” said Vijay Kotte, CEO of GoHealth. “We are particularly pleased with the performance of our internal captive agents despite unchanged shopping and switching dynamics since last year’s annual enrollment period (“AEP”). We anticipated year-over-year declines from Q1 through Q3, but our team has managed these expected dynamics by driving efficiencies. These results highlight the benefits of our proprietary Encompass workflow and PlanFit CheckUp process. GoHealth plays a critical role in helping Medicare eligible consumers navigate plan options every year. As we gear up for AEP in just 67 days, GoHealth is intensifying targeted marketing efforts to better identify and reach consumers in need of PlanFit CheckUp’s.”

“We also remain committed to leveraging our strengths and strategic initiatives to drive future growth,” continued Kotte. “GoHealth continues to advance our technology to ensure a seamless experience for agents and consumers. We believe that our advancements in artificial intelligence (“AI”) and automation are setting a new industry standard. Our proprietary technology leverages machine and deep learning models atop our sophisticated data platforms, enabling us to deliver more precise, data-driven insights and significantly enhance agent efficiency. We expect these innovations to streamline processes, provide dynamic personalization in our workflows, and improve our overall operational efficiency. By integrating AI and automation into our operations, we intend to not only enhance the consumer experience but also solidify our position as an industry leader in customer acquisition costs, represented by our Direct Cost of Submission.(2) With our consumer orientation and technology enablement, we are looking forward to continuing to support consumers during what we currently believe will be a dynamic AEP,” continued Kotte.

“We expect various factors to influence the second half of the year and we remain confident in our performance expectations for 2024. We anticipate growth in Submission volume, revenue, and Adjusted EBITDA,” said Katie O’Halloran, Interim CFO of GoHealth. “We believe our mix of agency versus non-agency agreements will be a key driver of our cash flow from operations performance. With our continued strategic focus and disciplined execution, we are committed to achieving our goals and delivering long-term value.”

(1)   Adjusted EBITDA is a non-GAAP measure. For a definition of Adjusted EBITDA and a reconciliation to the most comparable GAAP measure, please see below.

(2)   Direct Cost of Submission is a key operating metric. For a definition of Direct Cost of Submission and a description of how it is calculated, please see below.

Conference Call Details

The Company will host a conference call today, Thursday, August 8, 2024 at 8:00 a.m. (ET) to discuss its financial results. A live audio webcast of the conference call will be available via GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call.

About GoHealth, Inc.

GoHealth is a leading health insurance marketplace and Medicare-focused digital health company whose purpose is to compassionately ensure consumers’ peace of mind when making healthcare decisions so they can focus on living life. For many of these consumers, enrolling in a health insurance plan is confusing and difficult, and seemingly small differences between health plans may lead to significant out-of-pocket costs or lack of access to critical providers and medicines. GoHealth’s proprietary technology platform leverages modern machine-learning algorithms, powered by over two decades of insurance purchasing behavior, to reimagine the process of matching a health plan to a consumer’s specific needs. Its unbiased, technology-driven marketplace coupled with highly skilled licensed agents has facilitated the enrollment of millions of consumers in Medicare plans since GoHealth’s inception. For more information, visit https://www.gohealth.com.

Investor Relations:
John Shave
JShave@gohealth.com
 
Media Relations:
Pressinquiries@gohealth.com
 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements are made in reliance upon the safe harbor provision of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release may be forward-looking statements. Statements regarding our future results of operations and financial position, business strategy and plans and objectives of management for future operations, including, among others, statements regarding our expected growth, future capital expenditures, debt service obligations and adoption and use of artificial intelligence technologies are forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “aims,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “likely,” “future” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions, projections and other statements about future events that are based on current expectations and assumptions. 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.

These forward-looking statements speak only as of the date of this press release and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the factors described in the sections titled “Summary Risk Factors,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (“2023 Annual Report on Form 10-K”) and in our other filings with the Securities and Exchange Commission. The factors described in our 2023 Annual Report on Form 10-K should not be construed as exhaustive and should be read together with the other cautionary statements included in this press release, as well as the cautionary statements and other risk factors set forth in the Quarterly Report on Form 10-Q for the first fiscal quarter ended March 31, 2024, the forthcoming Quarterly Report on Form 10-Q for the second quarter ended June 30, 2024 and in our other filings with the Securities and Exchange Commission.

You should read this press release and the documents that we reference in this press release completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

View fill release HERE.