GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.
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.
GeoVax Made Significant Advances In 2Q24. GeoVax reported a 2Q24 loss of $5.1 million or $(1.99) per share. The company reviewed the progress made during the quarter, including the DARPA grant for the Phase 2 CM04S1 trial, two CM04S1 trials in immunocompromised cancer patients, and announcement of the Phase 2 Gedeptin trial design.
Financial Results Reflect First Grant Revenues. During 2Q, GeoVax recognized $0.3 million in revenues from work related to the Phase 2 CM04S1 trial. Revenue is recognized as the work is completed on a cost-reimbursement basis, with billings recorded as receivables. The company had $1.6 million in cash on June 30 and plans to raise capital in the near future.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , 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.
Electrical Systems. To our surprise, the segment had a difficult quarter, revenue decreased $13.5 million, or 21.2%. The decrease was largely attributed to a slow down in the construction and agriculture industries, and new contract wins taking longer to ramp up and at lower than expected volumes. In our view, the company is well positioned to capitalize on the industry rebound, anticipated to take place in 2025 & 2026.
Vehicle Solutions. The segment experienced a decrease of $11.8 million, or 7.7%, from the prior year period, which was primarily driven by softer demand and reorganization. Notably, the company anticipated a more drastic decline in the business and closed a plant, shifting manufacturing to three other existing facilities, which should improve cost structure over the long-term.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Lithium carbonate production at the pilot plant. Century Lithium successfully added a lithium carbonate stage at the company’s lithium extraction facility which is part of the company’s Angel Island Mine project. Recall that Century recently changed the name of its Clayton Valley Lithium project to Angel Island Mine to distinguish it from other projects. Previously, concentrated lithium solutions from the pilot plant were treated by Saltworks Inc. at their facility in Richmond, British Columbia to produce samples of battery grade lithium carbonate.
Following through on the feasibility study. Adding the lithium carbonate stage at the pilot plant satisfies one of the recommendations contained in the recently published feasibility study. Being able to produce battery grade lithium on site further demonstrates the commercial viability of the project and will also help the company to better optimize the process from the direct lithium extraction (DLE) phase through to production of the final product. Century successfully treated 200 liters of concentrated lithium solution and produced 20 kilograms of high-grade lithium carbonate on site.
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.
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.
AI and Staking. Bit Digital had 256 servers generating revenue during the quarter and earned an estimated $4.3 million of revenue during the month. The staking side had approximately 17,184 ETH actively staked, flat with last month, and earned a blended APY of approximately 3.3% on its staked ETH in the month of July, slightly down from last month’s 3.5%.
Mining Side. The Company produced 60.5 BTC in the month, a slight 1.9% decrease from the previous month. The active hash rate was roughly 2.46 EH/s, a decline from 2.57 EH/s in June. With the active goal of 6.0 EH/s at the end of 2024, we anticipate a ramp up in the hash rate during the last few months of the year.
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.
Key Points: – Rate cuts typically stimulate economic growth by reducing borrowing costs. – In today’s market, rate cuts may have limited impact due to already low rates and economic uncertainties. – Potential consequences include increased inflation risk and asset bubbles.
The Federal Reserve’s decision to cut interest rates is a powerful tool in monetary policy, often employed to stimulate economic growth during periods of slowdown or recession. Traditionally, rate cuts have been associated with increased borrowing, spending, and investment. However, in today’s unique economic landscape, the effects of such a move may be more nuanced and less predictable than in the past.
Typically, when the Fed lowers its benchmark interest rate, it sets off a chain reaction throughout the economy. Banks respond by reducing their prime lending rates, which in turn lowers the cost of borrowing for businesses and consumers. This cheaper access to credit can lead to increased spending and investment, potentially boosting economic growth and employment.
For businesses, lower interest rates can make it more attractive to take out loans for expansion, equipment purchases, or research and development. Consumers may find it easier to finance big-ticket items like homes and cars, or to refinance existing debt at more favorable terms. Additionally, lower rates often lead to a depreciation in the value of the dollar, which can benefit U.S. exporters by making their products more competitive in global markets.
However, the current economic environment presents unique challenges that may alter the effectiveness of rate cuts. Interest rates are already at historically low levels, leaving less room for significant reductions. The COVID-19 pandemic has introduced unprecedented uncertainties into the global economy, affecting consumer behavior, supply chains, and business operations in ways that may not be easily addressed by traditional monetary policy tools.
In today’s market conditions, a rate cut might have limited impact on stimulating growth. Many businesses and consumers are hesitant to take on new debt or make major investments due to ongoing economic uncertainties. The effectiveness of rate cuts may also be dampened by other factors such as high levels of existing debt, concerns about future tax increases to address growing government deficits, or fears of potential asset bubbles.
One potential consequence of further rate cuts in the current environment is an increased risk of inflation. As more money enters the economy through easier credit, there’s a possibility that prices could rise more rapidly, especially if supply chain disruptions persist. This could erode purchasing power and potentially lead to economic instability if not carefully managed.
Another consideration is the impact on savers and retirees who rely on interest income. Lower rates mean reduced returns on savings accounts, certificates of deposit, and other fixed-income investments. This can be particularly challenging for older adults who depend on these income streams to supplement their retirement.
The stock market often reacts positively to rate cuts in the short term, as lower borrowing costs can boost corporate profits and make stocks more attractive compared to bonds. However, this effect may be less pronounced in today’s market, where stock valuations are already high and investors are weighing numerous other factors beyond interest rates.
For the housing market, lower rates typically lead to increased affordability and demand. However, in the current climate of limited housing supply and already high home prices in many areas, further rate cuts may have a muted effect on home sales and could potentially contribute to unsustainable price increases.
In conclusion, while Federal Reserve rate cuts have historically been a reliable tool for stimulating economic growth, their effectiveness in today’s unique market conditions is less certain. Policymakers and market participants alike must carefully consider the potential benefits and risks of further rate reductions, given the complex interplay of factors affecting the current economy. As always, a balanced approach that considers monetary policy alongside fiscal measures and structural reforms may be necessary to navigate the challenges and opportunities presented by today’s economic landscape.
Key Points: – Russell 2000 index drops 3.31%, highlighting small cap vulnerability in current market – Economic uncertainty and investor risk aversion driving small cap sell-off – Long-term strategies and quality focus key for navigating small cap investments
The recent stock market plunge has sent shockwaves through various sectors, with small cap stocks bearing the brunt of the decline. On August 5, 2024, the Russell 2000 index, a key benchmark for small cap performance, plummeted 3.31%, while the broader Russell 3000 index fell 2.99%. These sharp drops highlight the increased volatility and unique challenges facing small cap investments during economic uncertainty.
Several factors have contributed to the recent sell-off in small cap stocks, including recession fears, disappointing corporate earnings, regulatory pressures on tech giants, and weaker-than-expected employment data. These concerns have led to a broad retreat from equities, with small cap stocks particularly vulnerable due to their less diversified revenue streams and higher sensitivity to economic shifts.
Small cap stocks, typically tracked by the Russell 2000, are known for their high growth potential but also significant volatility. Several factors contribute to their vulnerability during market downturns. Economic sensitivity is a key issue, as limited resources and less diversified operations make small caps more susceptible to economic fluctuations. Liquidity challenges also play a role, with lower trading volumes potentially exacerbating price swings during high market activity. Additionally, investor sentiment tends to shift towards more stable large cap stocks during uncertain times, leaving small caps to bear the brunt of sell-offs.
Despite these challenges, small cap stocks can offer substantial growth opportunities, especially during market recoveries when they tend to outperform larger counterparts. Recent performance metrics underscore the difficulties faced by small cap stocks, with the Russell 2000’s 3.31% decline and the Russell 3000’s 2.99% drop on August 5, 2024, reflecting increased volatility and risk aversion among investors.
For investors navigating the small cap sector during turbulent times, several strategies can be considered. Diversification remains crucial, spreading investments across various sectors and market capitalizations to mitigate risk. Focusing on quality is equally important, seeking out small cap companies with strong fundamentals, solid balance sheets, and competitive advantages. Dollar-cost averaging, which involves regularly investing fixed amounts, can help take advantage of market dips and reduce overall risk.
Adopting a long-term perspective is also vital, as small caps often outperform over extended periods despite short-term volatility. During economic uncertainty, investors might consider small caps in defensive sectors like healthcare or consumer staples, which tend to be more resilient during downturns.
While market downturns can be unsettling, they often present opportunities for long-term investors. Small cap stocks trading at discounted valuations may offer significant upside potential when the market recovers. Savvy investors can use this period to identify promising small cap companies with strong growth prospects and resilient business models.
In conclusion, the recent market decline has significantly impacted small cap stocks, as evidenced by the Russell 2000 and Russell 3000 index performances. While these stocks carry higher risks during economic uncertainty, they also offer compelling growth potential. By employing diversification, focusing on quality investments, and maintaining a long-term perspective, investors can navigate the challenges and capitalize on opportunities within the small cap sector.
It’s important to note that small cap investing requires careful consideration and research. The higher volatility and potential for significant gains or losses make it crucial for investors to thoroughly understand their risk tolerance and investment goals. Market conditions can change rapidly, and what works in one economic environment may not be suitable in another.
As the market continues to evolve, small cap stocks remain an important part of a well-rounded investment portfolio. Their potential for outsized returns during market recoveries makes them attractive to investors willing to weather short-term volatility for long-term gains. However, as with all investments, it’s essential to approach small cap investing with a well-thought-out strategy and, when in doubt, consult with a financial advisor to ensure your investment approach aligns with your personal financial objectives and risk tolerance.
PONTE VEDRA, Fla., Aug. 6, 2024 — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage, new-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions, announced today that it has been in discussions with Abbott (NYSE: ABT) about Cadrenal’s planned pivotal study of tecarfarin in patients with recently implanted LVADs. All patients with LVADs require lifelong anticoagulation (AC) to protect against thromboembolic events.
In April 2024, tecarfarin received FDA Orphan Drug Designation (ODD) to prevent blood clots and strokes in patients with implanted mechanical circulatory support devices such as LVADs.
Currently, the only LVAD available in the United States is the HeartMate 3™, manufactured by Abbott, which has been shown to be superior to all prior LVADs.
A recent secondary analysis of the ARIES-HM3 study conducted by Abbott on the necessity of aspirin therapy demonstrated that maintaining high-quality AC can result in further improvement of outcomes with the HeartMate 3 LVAD.
“We are pleased that Abbott has initiated a collaborative effort with us for this trial, which we believe is very important to LVAD patients,” said Quang Pham, Chairman and Chief Executive of Cadrenal Therapeutics. “We believe that tecarfarin has the potential to further improve AC treatment for HeartMate 3 patients.”
Prior clinical studies provide evidence that tecarfarin yields improved AC quality, particularly in patients on multiple medications and those with impaired renal function, both of which are common in LVAD patients.
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a new-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions. Tecarfarin has orphan drug designation from the FDA for the prevention of thrombosis and thromboembolism (blood clots) in patients with an implanted mechanical circulatory support device, which includes the left ventricular assist device (LVAD). Tecarfarin also has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Tecarfarin is specifically designed to use a different metabolism pathway than the oldest and most commonly prescribed VKA warfarin. Tecarfarin has been evaluated in eleven (11) human clinical trials in more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit www.cadrenal.com.
Safe Harbor Statement
Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding Cadrenal’s planned pivotal study of tecarfarin in patients with recently implanted LVADs, maintaining high-quality AC resulting in further improvement of outcomes with the HeartMate 3 LVAD, the collaborative effort with Abbott for the trial being very important to LVAD patients and tecarfarin having the potential to further improve AC treatment for HeartMate 3 patients. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to improve outcomes in patients with a HeartMate 3, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices (LVADs), and those with AFib and ESKD, the collaboration with Abbott being successful and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
For more information, please contact:
Cadrenal Therapeutics: Matthew Szot, CFO 858-337-0766 press@cadrenal.com
Investors: Lytham Partners, LLC Robert Blum, Managing Partner 602-889-9700 CVKD@lythampartners.com
JERICHO, N.Y.–(BUSINESS WIRE)– 1-800-FLOWERS.COM, Inc. (NASDAQ: FLWS) (the “Company”),a leading provider of gifts designed to help inspire customers to give more, connect more, and build more and better relationships, today announced that the Company will release financial results for its fiscal 2024 fourth quarter and year-end on Thursday, August 29, 2024. The press release will be issued prior to market opening and will be followed by a conference call with members of senior management at 8:00 a.m. (ET).
The conference call will be available via live webcast from the Investors section of the Company’s website at www.1800flowersinc.com/investors. A recording of the call will be posted on the website within two hours of the call’s completion. A telephonic replay of the call can be accessed beginning at 2:00 p.m. (ET) on August 29, 2024, through September 5, 2024, at: (US) 1-877-344-7529; (Canada) 855-669-9658; (International) 1-412-317-0088; enter conference ID: #5141252.
Special Note Regarding Forward-Looking Statements:
Some of the statements contained in the Company’s scheduled Thursday, August 29, 2024, press release and conference call regarding its results for its fiscal 2024 fourth quarter and year-end, other than statements of historical fact, may be forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the applicable statements. For a more detailed description of these and other risk factors, please refer to the Company’s SEC filings including its Annual Reports and Forms 10K and 10Q available at the Investor Relations section of the Company’s website at 1800flowersinc.com. The Company expressly disclaims any intent or obligation to update any of the forward-looking statements made in the scheduled conference call and any recordings thereof, or in any of its SEC filings, except as may be otherwise stated by the Company.
About 1-800-FLOWERS.COM, Inc.
1-800-FLOWERS.COM, Inc. is a leading provider of gifts designed to help inspire customers to give more, connect more, and build more and better relationships. The Company’s e-commerce business platform features an all-star family of brands, including: 1-800-Flowers.com®, 1-800-Baskets.com®, Cheryl’s Cookies®, Harry & David®, PersonalizationMall.com®, Shari’s Berries®, FruitBouquets.com®, Things Remembered®, Moose Munch®, The Popcorn Factory®, Wolferman’s Bakery®, Vital Choice®, and Simply Chocolate®. Through the Celebrations Passport® loyalty program, which provides members with free standard shipping and no service charge on eligible products across our portfolio of brands, 1-800-FLOWERS.COM, Inc. strives to deepen relationships with customers. The Company also operates BloomNet®, an international floral and gift industry service provider offering a broad-range of products and services designed to help members grow their businesses profitably; Napco℠, a resource for floral gifts and seasonal décor; DesignPac Gifts, LLC, a manufacturer of gift baskets and towers; and Alice’s Table®, a lifestyle business offering fully digital livestreaming and on demand floral, culinary and other experiences to guests across the country. 1-800-FLOWERS.COM, Inc. was recognized among America’s Most Trustworthy Companies by Newsweek. 1-800-FLOWERS.COM, Inc. was also recognized among the top 5 on the National Retail Federation’s 2021 Hot 25 Retailers list, which ranks the nation’s fastest-growing retail companies, and was named to the Fortune 1000 list in 2022. Shares in 1-800-FLOWERS.COM, Inc. are traded on the NASDAQ Global Select Market, ticker symbol: FLWS. For more information, visit 1800flowersinc.com.
August 6, 2024 – Vancouver, Canada – Century Lithium Corp. (TSXV:LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (Century Lithium or the Company) is pleased to report the successful addition of a lithium carbonate stage at the Company’s Lithium Extraction Facility (Pilot Plant) in Amargosa Valley, Nevada, USA, part of the Company’s 100%-owned Angel Island Mine (the Project). Prior to this addition, concentrated lithium solutions from the Pilot Plant were treated by Saltworks Inc. at their facility in Richmond B.C. where samples of battery quality lithium carbonate were produced. During the first days of startup of the lithium carbonate stage, Century’s team at the Pilot Plant successfully treated 200 liters of concentrated lithium solution and produced 20 kg of high-grade lithium carbonate onsite.
“At this point in time, the ability to make lithium carbonate at our Pilot Plant is an important step forward, in line with recommendations from our recently completed Feasibility Study” commented President and CEO Bill Willoughby. “The drop in lithium prices over the last year has taken a toll on the share price of all lithium companies. Despite the downturn, domestic production is still key to the security of supply in the U.S. While it is becoming well known that a vast amount of lithium is contained within the claystone deposits of Nevada, the benefit in unlocking these resources is the ability to produce a battery quality lithium product onsite and thereby reducing or eliminating the need for downstream processing.”
The Company continues work at the Pilot Plant, utilizing the Company’s patent-pending process for chloride leaching combined with Direct Lithium Extraction (DLE) to generate data as the Company works to identify further technological breakthroughs to make the extraction of lithium from clay more economic. Adding the lithium carbonate stage at the Pilot Plant is one of the recommendations made in the Feasibility Study, not only to further demonstrate that battery quality lithium carbonate can be made, but to better understand and minimize the recycle streams from the DLE stage through to final product in the process. With the assistance of engineers from Hargrove Engineers and Constructors, Century’s team configured equipment to run 40-liter batches of concentrated lithium solution though precipitation, washing and drying steps. Final assays on the lithium carbonate are pending.
Qualified Person
Todd Fayram, MMSA-QP and Senior Vice President, Metallurgy of Century Lithium is the qualified person as defined by National Instrument 43-101 and has approved the technical information in this release.
ABOUT CENTURY LITHIUM CORP.
Century Lithium Corp. is an advanced stage lithium company, focused on developing its 100%-owned Angel Island Mine in west-central Nevada, USA. Century Lithium recently completed a Feasibility Study on its Clayton Valley Lithium Project and is currently in the permitting stage, with the goal of becoming a domestic producer of lithium for the growing electric vehicle and battery storage market.
ON BEHALF OF CENTURY LITHIUM CORP. WILLIAM WILLOUGHBY, PhD., PE President & Chief Executive Officer
NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.
This release contains certain forward-looking statements within the meaning of applicable Canadian securities legislation. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved” and similar expressions suggesting future outcomes or statements regarding an outlook.
Forward-looking statements relate to any matters that are not historical facts and statements of our beliefs, intentions and expectations about developments, results and events which will or may occur in the future, without limitation, statements with respect to the potential development and value of the Project and benefits associated therewith, statements with respect to the expected project economics for the Project, such as estimates of life of mine, lithium prices, production and recoveries, capital and operating costs, IRR, NPV and cash flows, any projections outlined in the Feasibility Study in respect of the Project, the permitting status of the Project and the Company’s future development plans.
These and other forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein.These risks include those described under the heading “Risk Factors” in the Company’s most recent annual information form and its other public filings, copies of which can be under the Company’s profile at www.sedarplus.com. The Company expressly disclaims any obligation to update-forward-looking information except as required by applicable law. No forward-looking statement can be guaranteed and actual future results may vary materially. Accordingly, readers are advised not to place reliance on forward-looking statements or information. Furthermore, Mineral Resources that are not Mineral Reserves do not have demonstrated economic viability.
High-throughput, high-content imaging-based assay developed to screen convalescent sera for neutralizing antibodies to SARS-CoV-2 variants
Study highlights Tonix’s internal R&D capabilities in infectious disease that include a COVID-19 vaccine selected by NIH for Project NextGen and a host-directed anti-viral program awarded a DoD/DTRA contract for up to $34 million
CHATHAM, N.J., Aug. 06, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the publication of a research paper in Microorganisms, a scientific, peer-reviewed, open access journal of microbiology. The article titled, “High-Throughput Screening Assay for Convalescent Sera in COVID-19: Efficacy, Donor Selection, and Variant Neutralization,” by Kota, et al.1, highlights proprietary high-throughput, high-content imaging technology to screen convalescent sera for generating neutralizing, fully-human monoclonal antibodies (mAbs) against SARS-CoV-2 variants and potentially other pathogens.
“This article highlights Tonix’s capabilities in developing fully human mAbs against SARS-CoV-2 and other pathogens,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Our phenotypic imaging system can be used to identify antibodies to counter SARS-CoV-2 and its variants and potentially other infectious agents.”
“COVID-19 rates are on the rise again, and there is growing concern that the short-term protection provided by mRNA vaccines may not be sufficient to control COVID-19 as a public health threat,” continued Dr. Lederman. “Our new publication highlights the capabilities of Tonix’s screening and therapeutic discovery and development technologies.”
In addition to this technology, Tonix has several other research and development programs to prevent and treat viral illnesses. Tonix is developing TNX-801, a live-virus vaccine based on horsepox to protect against mpox and smallpox. TNX-801 is also the vector underlying our Recombinant Pox Virus (RPV) platform technology and to engineer vaccines to protect against other viruses. TNX-1800, which uses the RPV technology, is a potential vaccine against COVID-19 that was selected by National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), for inclusion in clinical trials as part of its Project NextGen for prevention of COVID-19. Tonix also is developing TNX-4200, an orally available CD45 antagonist with broad-spectrum efficacy against a range of viral families. Tonix recently was awarded a $34 million contract from the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA), to establish physicochemical properties, pharmacokinetics, and safety attributes to support an Investigational New Drug submission and to fund a first-in-human Phase 1 clinical study using TNX-4200.
In support of our infectious disease programs, Tonix’s experienced team utilizes state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at our research and development center (RDC) located in Frederick, Md. The RDC is located in Maryland’s “I-270 biotech corridor” and is close to the center of the U.S. biodefense research community.
About TNX-4200* The TNX-4200 program aims to develop an orally available CD45 antagonist, with broad-spectrum efficacy against a range of viral families through preclinical evaluation. The program is expected to establish physicochemical properties, pharmacokinetics, and safety attributes to support an Investigational New Drug (IND) submission and to fund a first-in-human Phase 1 clinical study. Through our agreement with DTRA, our broad-spectrum antiviral research program will address the DoD’s goal of protecting U.S. Joint Forces in the event biological weapons are introduced onto the battlefield. The $34 million five-year contract will help fund and accelerate the development of the Company’s broad-spectrum antiviral program, which has the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. Tonix plans to leverage previous research on phosphatase inhibitors, specifically compounds that target CD45, to optimize lead compounds for therapeutic intervention of biothreat agents and provide the government with a complete and cost-effective solution for a broad-spectrum medical countermeasure. Tonix’s premise is that partial inhibition of CD45 will provide optimal antiviral protection while requiring lower plasma drug concentrations, a lower dose, and a better safety profile.
About Project NextGen Project NextGen is a $5 billion initiative to develop the next generation of vaccines and therapeutics to combat COVID-19. Based at the HHS and led by the Administration for Strategic Preparedness and Response’s Biomedical Advanced Research and Development Authority and the NIH’s NIAID, Project NextGen was stood up to coordinate across the federal government and the private sector to advance the pipeline of new, innovative vaccines and therapeutics into clinical trials and potential review by the U.S. Food and Drug Administration (FDA) for authorization or approval, and commercial availability for the American people. The program will focus on several areas, including mucosal vaccines, vaccines that provide broader protection against variants of concern and a longer duration of protection, pan-coronavirus vaccines, and new and more durable monoclonal antibodies.
About TNX-801* and Tonix’s RPV Platform TNX-801 (recombinant horsepox virus) is a live virus vaccine for percutaneous administration that is being developed to target smallpox, and mpox (monkeypox). TNX-801 is also the basis of the RPV platform based on a horsepox vector, which is being adapted as a COVID-19 vaccine, term TNX-1800*. Horsepox is a live replicating, attenuated virus that has been shown to be >1,000-fold more attenuated than modern vaccinia (VACV) strains in immunocompromised mice.2 Horsepox and the vaccinia vaccine viruses are closely related orthopoxviruses that are believed to share a common ancestor. Molecular analysis shows that horsepox is closer than modern vaccinia vaccines in DNA sequence to the vaccine discovered and disseminated by Dr. Edward Jenner. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice. The current formulation is a frozen liquid, but we believe that future lyophilized versions can be stored and shipped at standard refrigeration. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines that can be administered without sterile injection, manufactured using conventional cell culture systems with the potential for mass scale production, and packaged in multi-dose vials.
About TNX-1800* TNX-1800 (recombinant horsepox virus) is a live virus vaccine for percutaneous administration that is designed to express the spike protein of the SARS-CoV-2 virus and to elicit a predominant T cell response. Moreover, we believe the low dose of TNX-1800 makes this technology amenable for future implementation in microneedle delivery systems. NIAID will cover the full cost of Phase 1 clinical trials, while Tonix will supply the vaccine candidate. The intent is to provide durable protection against severe disease and prevent forward transmission, primarily by eliciting a T-cell immune response. TNX-1800 expresses the spike protein of SARS-CoV-2, was immunogenic, well tolerated3 and showed promise in protecting animals from challenge with SARS-CoV-2 delivered directly into the lungs.4
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 U.S. Food and Drug Administration (FDA) in the second half of 2024 for TNX-102 SL*, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL was awarded Fast Track designation from the FDA. Tonix expects a decision on marketing approval from the FDA in 2025. TNX-102 SL is also being developed to treat acute stress reaction. 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 an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease 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.
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.
Kota, K.P. et al. (2024) Microorganisms July 23, 2024.https://doi.org/10.3390/microorganisms1208150
Trefry, SV et al., BioRxiv 2023.10.25.564033; doi: https://doi.org/10.1101/2023.10.25.564033
Awasthi M, et al. Viruses. 2023. 15(10):2131. doi: 10.3390/v15102131.
Awasthi M et al Vaccines (Basel). 2023. 11(11):1682. doi: 10.3390/vaccines11111682.PMID: 38006014
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on 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.
Key Points: – Seres Therapeutics to sell VOWST assets to Nestlé Health Science for an undisclosed sum – Transaction expected to retire Seres’ debt and extend cash runway into Q4 2025 – Company to refocus on developing SER-155 and other cultivated microbiome therapeutics
Seres Therapeutics has announced plans to sell its groundbreaking microbiome therapy VOWST to Nestlé Health Science. This transaction, detailed in a non-binding memorandum of understanding, marks a significant shift in Seres’ business strategy and financial outlook.
VOWST, approved by the FDA in April 2023, made history as the first orally administered microbiome therapeutic for preventing recurrent Clostridioides difficile infection (CDI). The drug’s development and initial commercialization were part of a license agreement between Seres and Nestlé Health Science, established in July 2021. Now, Nestlé Health Science is poised to take full ownership of VOWST, consolidating its position in the microbiome therapeutics market.
For Seres, this deal represents more than just a product sale. It’s a calculated decision to strengthen its financial position and refocus its efforts on developing new microbiome-based treatments. The company expects to receive capital infusions, including an upfront payment, which will be used to fully retire its existing debt facility with Oaktree Capital Management. This financial restructuring is projected to extend Seres’ cash runway into the fourth quarter of 2025, providing crucial time and resources for its next phase of development.
Eric Shaff, President and CEO of Seres, emphasized the company’s pride in bringing VOWST to market and assured a smooth transition of the product to Nestlé Health Science. He highlighted the exciting new chapter ahead for Seres, focusing on advancing SER-155 and other wholly-owned cultivated microbiome therapeutic candidates.
The company’s future pipeline targets several underserved patient groups, including those with chronic liver disease, cancer neutropenia, and solid organ transplants. Seres’ approach aims to protect medically vulnerable patients from life-threatening infections while addressing the global challenge of antimicrobial resistance (AMR).
SER-155, currently in a Phase 1b study, is at the forefront of Seres’ new direction. The drug is being evaluated in patients receiving allogeneic hematopoietic stem cell transplantation, with the potential to reduce gastrointestinal and related bloodstream infections, as well as the incidence of acute graft-versus-host disease.
This strategic pivot allows Seres to concentrate its resources on developing innovative microbiome therapeutics that could have far-reaching impacts on patient care. By divesting VOWST, the company is betting on its ability to create value through its pipeline of cultivated oral microbiome therapeutics.
The transaction, expected to close within 90 days, is subject to negotiation of definitive agreements, Seres’ shareholder approval, and other customary conditions. During the transition, Seres will support the full transfer of VOWST to Nestlé Health Science and ensure continuity of the supply chain through a transition service agreement.
This deal underscores the dynamic nature of the biotech industry, where companies must often make bold moves to secure their financial future and pursue promising research avenues. For Seres Therapeutics, selling VOWST represents both an end and a beginning – closing the chapter on its first FDA-approved product while opening new possibilities in microbiome therapeutics development.
As the microbiome therapeutics field continues to evolve, all eyes will be on Seres to see how this strategic shift plays out in the coming years. The success of this transaction and the company’s future pipeline could have significant implications not just for Seres, but for the broader landscape of microbiome-based treatments.
Operating income of $27.4 million; adjusted operating income1 of $65.8 million
Net loss of $6.5 million, down $8.3 million y/y
Adjusted EBITDA1 of $72.3 million with a margin1 of 6.7%
Diluted EPS of ($0.21); Adjusted diluted EPS1 of $0.83
Over $4 billion of recent awards, including a new award valued up to $3.0+ billion to provide next generation readiness
Successfully repriced and extended $904 million Term Loan B
2024 Guidance:
Raising full-year revenue guidance and reaffirming Adjusted EBITDA, EPS, and Operating Cash Flow1
MCLEAN, Va., Aug. 6, 2024 /PRNewswire/ — V2X, Inc. (NYSE:VVX) announced second quarter 2024 financial results.
“I am honored to join the V2X team and look forward to leveraging our mission first culture, differentiated capabilities, and impressive past performance to achieve our next stage of growth,” said Jeremy C. Wensinger, President and Chief Executive Officer of V2X. “Our people, processes, agility and expertise to operate worldwide are a differentiator. This enables alignment to critical missions with an ability to operate at scale around the globe.”
Mr. Wensinger continued, “Demand remains strong for our mission based full lifecycle solutions and was demonstrated through several recent awards valued at over $4 billion. This includes a new five-year award valued at $3.0+ billion to deliver next generation readiness. In addition, we received a new production award from the U.S. Army for our Gateway Mission Routers valued at $49 million, an award valued at $265 million to support NASA’s operations in preparation for human spaceflight missions at the Johnson Space Center, and the award of the F-5 adversarial aircraft program from the U.S. Navy valued at $747 million.”
“Importantly, our ability to deliver a full range of assured communications has resulted in two awards, further expanding our relationship with the Navy and our footprint in the Pacific. Our $88 million Naval Computer and Telecommunications Pacific award will provide vital C4I support to forces across the Pacific and Indian Oceans. Our $141 million Fleet Systems Engineering Team (FSET) program will continue to deliver end-to-end C4I systems engineering solutions. FSET ensures that no U.S. Navy Strike Group deploys without V2X.”
Mr. Wensinger concluded, “V2X has great momentum and I believe there is substantial opportunity to build upon the impressive foundation by further leveraging technology and solutions to enhance business and customer outcomes.”
Second Quarter 2024 Results
“V2X reported record revenue of $1.07 billion in the quarter, which represents 10% year-over-year growth,” said Shawn Mural, Senior Vice President and Chief Financial Officer. “Revenue growth in the quarter was achieved through continued expansion of existing business in the Pacific and Middle East regions, as well as new programs. Revenue growth in the Pacific was 29% year-over-year and 23% on a sequential basis, driven by continued expansion of scope and services in the region. Revenue growth in the Middle East was also 29% year-over-year, driven primarily by expansion in Qatar and the continued phase-in of our longer-term Saudi Aviation Training and Support Services program.”
“For the quarter, the Company reported operating income of $27.4 million and adjusted operating income1 of $65.8 million. Adjusted EBITDA1 was $72.3 million with a margin of 6.7%. Second quarter GAAP diluted EPS was ($0.21). Adjusted diluted EPS1 for the quarter was $0.83. The adjusted tax rate in the second quarter was 28% due to the executive transition. Absent this, our adjusted tax rate would have been approximately 23% yielding adjusted EPS of $0.88.”
“Year to date, net cash used by operating activities was $31.6 million, reflective of working capital requirements to support growth. Adjusted net cash used by operating activities1 was $137.3 million, adding back approximately $12.1 million of M&A and integration costs and removing the contribution of the master accounts receivable purchase or MARPA facility of $117.8 million.”
“At the end of the quarter, net debt for V2X was $1,150 million. Net leverage ratio1,2 was 3.56x, essentially flat compared to the first quarter 2024. We expect to achieve a net leverage ratio of 3.0x, by the end of 2024. During the quarter, we successfully repriced and extended our $904 million Term Loan B. This outcome is a testament to the strength in our business and is yielding additional interest expense savings while lowering our overall cost of capital.”
“Total backlog as of June 28, 2024, was $12.2 billion. Funded backlog was $2.9 billion. Bookings in the quarter were $759 million. We expect backlog to increase in the second half of the year due to awards and contract definitizations.”
Raising 2024 Revenue Guidance
Mr. Mural concluded, “Given our strong revenue performance in the first half of the year we are updating our total year guidance.”
Guidance for 2024 is as follows:
The Company is not providing a quantitative reconciliation with respect to this forward-looking non-GAAP measure in reliance on the “unreasonable efforts” exception set forth in SEC rules because certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. For example, unusual, one-time, non-ordinary, or non-recurring costs, which relate to M&A, integration and related activities cannot be reasonably estimated. Forward-looking statements are based upon current expectations and are subject to factors that could cause actual results to differ materially from those suggested here, including those factors set forth in the Safe Harbor Statement below.
Second Quarter Conference Call
Management will conduct a conference call with analysts and investors at 8:00 a.m. ET on Tuesday, August 6, 2024. 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 here: https://app.webinar.net/Aba2LPOkBXe
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.
Presentation slides that will be used in conjunction with the conference call will also be made available online in advance on the “investors” section of the company’s website at https://gov2x.com. V2X recognizes its website as a key channel of distribution to reach public investors and as a means of disclosing material non-public information to comply with its obligations under the U.S. Securities and Exchange Commission (“SEC”) Regulation FD.
Footnotes:
1 See “Key Performance Indicators and Non-GAAP Financial Measures” for descriptions and reconciliations. 2 Net leverage ratio of 3.6x equals net debt of $1,150 million divided by trailing twelve-month (TTM) bank EBITDA of $322.7 million.
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.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995 (the “Act”): Certain material presented herein includes forward-looking statements intended to qualify for the safe harbor from liability established by the Act. These forward-looking statements include, but are not limited to, all the statements and items listed under “2024 Guidance” above and other assumptions contained therein for purposes of such guidance, other statements about our 2024 performance outlook, revenue, contract opportunities, and any discussion of future operating or financial performance.
Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may,” “will,” “expect,” “intend,” “estimate,” “anticipate,” “believe,” “could,” “potential,” “continue” or similar terminology. These statements are based on the beliefs and assumptions of the management of the Company based on information currently available to management.
These forward-looking statements are not guarantees of future performance, conditions, or results, and involve a number of known and unknown risks, uncertainties, assumptions, and other important factors, many of which are outside our management’s control, which could cause actual results to differ materially from the results discussed in the forward-looking statements. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the Company’s historical experience and our present expectations or projections. For a discussion of some of the risks and uncertainties that could cause actual results to differ from such forward-looking statements, see the risks and other factors detailed from time to time in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other filings with the SEC.
We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
EPS of $(0.05), Adjusted EPS of $0.06, reflecting additional restructuring activity
Adjusted EBITDA of $10.0 million,free cash flow of $6.4 million
Strategic actions taken to strengthen Vehicle Solutions Business
Provides updated guidance for full year 2024
NEW ALBANY, Ohio, Aug. 05, 2024 (GLOBE NEWSWIRE) — CVG (NASDAQ: CVGI), a diversified industrial products and services company, today announced financial results for its second quarter ended June 30, 2024.
Second Quarter 2024 Highlights(Compared with prior year, where comparisons are noted)
Revenues of $229.9 million, down 12.3%, due primarily to a global softening in customer demand.
Operating income of $0.8 million, down 95.2%; adjusted operating income of $5.7 million, down 65.9%. The decrease in operating income was driven primarily by lower sales volumes, partially offset by reduced SG&A.
New business wins in the quarter of approximately $32 million when fully ramped, bringing the year-to-date total to $80 million; these wins were concentrated in our Electrical Systems segment, and includes meaningful wins in our Vehicle Solutions segment.
Net loss of $1.6 million, or $(0.05) per diluted share and adjusted net income of $2.1 million, or $0.06 per diluted share, compared to net income of $10.1 million, or $0.30 per diluted share and adjusted net income of $10.7 million, or $0.32 per diluted share.
Adjusted EBITDA of $10.0 million, down 51.9%, with an adjusted EBITDA margin of 4.3%, down from 7.9%.
James Ray, President and Chief Executive Officer, said, “CVG continues to drive its strategic transformation, despite second quarter results that were challenged due to multiple factors. In particular, we witnessed continued softening in the construction and agricultural end markets and reduced volumes in our new business win launches, impacting our key growth segment in Electrical Systems. We also experienced operational inefficiencies in our Vehicle Solutions segment resulting from a new product launch with a major customer across multiple sites as well as activities to prepare our Cab Structures Business for sale. We made incremental investments in both internal and external support teams deployed to the affected facilities and expect to achieve more stability during the balance of the year. These market dynamics and operational activities weighed on second quarter profitability. While we are disappointed with our second quarter performance, we are taking proactive steps to right-size our cost structure and improve operational execution as we navigate a lower demand environment.”
Mr. Ray concluded, “Despite these challenges in the second quarter, we continue to position CVG for future success. We maintained our strong track record of procuring new business wins in the quarter and recently announced the sale of our Cab Structures Business, that is expected to close in the second half of 2024, which will serve to further streamline our product portfolio and aligns with our transformation strategy to reduce cyclicality, balance customer concentration, and strengthen our Vehicle Solutions business. We expect the trend of OEM’s insourcing components of their cab manufacturing to continue, so monetizing the facility now will create value for shareholders and will allow us to redeploy capital in key areas to improve our operating model. Strategic actions like this one, combined with our ongoing cost reduction and business optimization efforts, are expected to position CVG to benefit from the anticipated improvement in market conditions.”
Andy Cheung, Chief Financial Officer, added, “We are taking swift action to respond to the end market and operational challenges through restructuring and headcount reduction efforts to improve profitability. We’ve incurred $6.8 million in restructuring expenses year-to-date and have reduced our headcount by more than 10%. Additionally, we have made progress on the strategic evaluation of our Industrial Automation segment, which we believe will culminate in the third quarter of this year and is reflected in our guidance. We are adjusting our annual guidance ranges for fiscal year 2024 to reflect current market trends to include the deterioration in global construction and agriculture markets, and we are providing an adjusted version of the updated guidance for the Cab Structures and Industrial Automation businesses. Following closing, we anticipate that the majority of the disposition proceeds will support debt paydown as we further strengthen our balance sheet.”
Second Quarter Financial Results (amounts in millions except per share data and percentages)
Consolidated Results
Second Quarter 2024 Results
Second quarter 2024 revenues were $229.9 million, compared to $262.2 million in the prior year period, a decrease of 12.3%. The overall decrease in revenues was due to a softening in customer demand impacting all segments and the wind-down of certain programs in our Vehicle Solutions segment.
Operating income in the second quarter 2024 was $0.8 million compared to $15.9 million in the prior year period. The decrease in operating income was attributable to the impact of lower sales volumes, operational inefficiencies and increased restructuring charges. Second quarter 2024 adjusted operating income was $5.7 million, compared to $16.7 million in the prior year period.
Interest associated with debt and other expenses was $2.5 million and $2.8 million for the second quarter 2024 and 2023, respectively.
Net loss was $1.6 million, or $(0.05) per diluted share, for the second quarter 2024 compared to net income of $10.1 million, or $0.30 per diluted share, in the prior year period.
On June 30, 2024, the Company had $7.0 million of outstanding borrowings on its U.S. revolving credit facility and no outstanding borrowings on its China credit facility, $39.3 million of cash and $152.9 million of availability from the credit facilities, resulting in total liquidity of $192.2 million.
Second Quarter 2024 Segment Results
Vehicle Solutions Segment
Revenues were $140.9 million compared to $152.7 million for the prior year period, a decrease of 7.7%, due to lower customer demand and the wind-down of certain operations.
Operating income was $5.1 million, compared to $14.1 million in the prior year period, a decrease of 64.1%, primarily attributable to lower customer demand, operational remediation investments, and increased freight costs partially offset by lower SG&A. Second quarter 2024 adjusted operating income was $8.3 million compared to $14.5 million in the prior year period.
Electrical Systems Segment
Revenues were $50.2 million compared to $63.6 million in the prior year period, a decrease of 21.2%, primarily due to a global softening in the Construction & Agriculture end-markets and the phase out of certain lower margin business.
Operating income was $0.5 million compared to $7.7 million in the prior year period, a decrease of 93.4%. The decrease in operating income was primarily attributable to lower customer demand, restructuring costs, labor inflation, and unfavorable foreign exchange impacts. Second quarter 2024 adjusted operating income was $1.9 million compared to $7.7 million in the prior year period.
Aftermarket & Accessories Segment
Revenues were $33.9 million compared to $36.8 million in the prior year period, a decrease of 8.1%, primarily as a result of lower sales volume due to decreased customer demand and the reduction of backlog in the prior period.
Operating income was $4.5 million compared to $5.5 million in the prior year period, a decrease of 19.4%. The decrease in operating income was primarily attributable to lower sales volumes, product mix and higher labor and benefit costs. Second quarter 2024 adjusted operating income was $4.7 million compared to $5.5 million in the prior year period.
Industrial Automation Segment
Revenues were $5.0 million compared to $9.0 million in the prior year period, a decrease of 44.6%, as a result of lower sales volume due to decreased customer demand.
Operating loss was $1.0 million, compared to $2.1 million in the prior year period. The decrease in operating loss was primarily attributable to benefits from recently implemented restructuring programs. Second quarter 2024 adjusted operating loss was $0.9 million, compared to $1.7 million in the prior year period.
Outlook
CVG issued the following outlook for the full year 2024 which reflects both market developments and pending strategic portfolio actions:
Metric
Prior 2024 Outlook
Revised 2024 Outlook
Adjusted Revised 2024 Outlook(1)
Net Sales
$915 – $1,015
$900 – $960
$730 – $780
Adjusted EBITDA
$60 – $73
$42 – $52
$28 – $36
(1) This Adjusted Revised outlook excludes any contribution from CVG’s Cab Structures or Industrial Automation businesses in 2024. On July 31, 2024, CVG signed an asset purchase agreement for the sale of the Cab Structures business with closing expected in the second half of 2024. Separately, CVG is currently exploring strategic alternatives for the Industrial Automation business.
This outlook reflects, among others, current industry forecasts for North America Class 8 truck builds. According to ACT Research, 2024 North American Class 8 truck production levels are expected to be at 308,000 units. The 2023 actual Class 8 truck builds according to the ACT Research was 340,247 units.
Agriculture and construction market conditions have deteriorated relative to our prior update in March 2024. Based on industry data, we now project segments within global agriculture market demand to be down 15% to 20% and construction market demand to be down 10% to 15% in 2024.
GAAP to Non-GAAP Reconciliation
A reconciliation of GAAP to non-GAAP financial measures referenced in this release is included as Appendix A to this release.
Conference Call
A conference call to discuss this press release is scheduled for Tuesday, August 6, 2024, at 8:30 a.m. ET. Management intends to reference the Q2 2024 Earnings Call Presentation during the conference call. To participate, dial (800) 549-8228 using conference code 11335. International participants dial (289) 819-1520 using conference code 11335.
This call is being webcast and can be accessed through the “Investors” section of CVG’s website at ir.cvgrp.com, where it will be archived for one year.
A telephonic replay of the conference call will be available for a period of two weeks following the call. To access the replay, dial (+1) 888 660 6264 using access code 11335#.
Company Contact Andy Cheung Chief Financial Officer CVG IR@cvgrp.com
Investor Relations Contact Ross Collins or Stephen Poe Alpha IR Group CVGI@alpha-ir.com
About CVG
At CVG, we deliver real solutions to complex design, engineering and manufacturing problems while creating positive change for our customers, industries and communities we serve. Information about the Company and its products is available on the internet at www.cvgrp.com.
Forward-Looking Statements
This press release contains forward-looking statements that are subject to risks and uncertainties. These statements often include words such as “believe”, “anticipate”, “plan”, “expect”, “intend”, “will”, “should”, “could”, “would”, “project”, “continue”, “likely”, and similar expressions. In particular, this press release may contain forward-looking statements about the Company’s expectations for future periods with respect to closing of the recently announced sale of its Cab Structures Business, its plans to improve financial results, the future of the Company’s end markets, changes in the Class 8 and Class 5-7 North America truck build rates, performance of the global construction and agricultural equipment business, the Company’s prospects in the wire harness, warehouse automation and electric vehicle markets, the Company’s initiatives to address customer needs, organic growth, the Company’s strategic plans and plans to focus on certain segments, competition faced by the Company, volatility in and disruption to the global economic environment and the Company’s financial position or other financial information. These statements are based on certain assumptions that the Company has made in light of its experience as well as its perspective on historical trends, current conditions, expected future developments and other factors it believes are appropriate under the circumstances. Actual results may differ materially from the anticipated results because of certain risks and uncertainties, including those included in the Company’s filings with the SEC. There can be no assurance that statements made in this press release relating to future events will be achieved. The Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results over time. All subsequent written and oral forward-looking statements attributable to the Company or persons acting on behalf of the Company are expressly qualified in their entirety by such cautionary statements.
Other Information
Throughout this document, certain numbers in the tables or elsewhere may not sum due to rounding. Rounding may have also impacted the presentation of certain year-on-year percentage changes.
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