Release – Fazoli’s Opens Second Little Rock Location

Research News and Market Data on FAT

09/20/2023

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Hot and Fresh Breadsticks Now Cooking on the West Side

LOS ANGELES, Sept. 20, 2023 (GLOBE NEWSWIRE) — Fazoli’s, America’s favorite fast and fresh Italian chain, has opened its second location in Little Rock. Located at 11410 W. Markham St., the location is now serving up its beloved hot and buttery breadsticks and signature Italian dishes including pastasubs, salads and pizzas. 

“We have loved serving the Little Rock community and look forward to making our fast and fresh Italian offerings more convenient to the west side of town,” said Doug Bostick, President at Fazoli’s. “Our second location in Little Rock is just the beginning of our commitment to growth in Arkansas, so stay tuned for more updates.” 

Since 1988, Fazoli’s has been committed to serving quality Italian food, fast, fresh, and friendly. From unlimited signature breadsticks to freshly prepared pasta entrees, the chain prides itself on serving high-quality menu offerings, all at an affordable price. 

The Little Rock Fazoli’s is located at 11410 W. Markham St. Little Rock, AR 72212. Drive-thru and dine-in are open 10:30 a.m. to 10 p.m., seven days a week. 

For more information, visit Fazolis.com

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit fatbrands.com

About Fazoli’s

Fast. Fresh. Italian. Founded in 1988 in Lexington, Ky., Fazoli’s owns and operates nearly 220 restaurants in 27 states, making it the largest QSR Italian chain in America. Fazoli’s prides itself on serving quality Italian food, fast, fresh and friendly. Menu offerings include freshly prepared pasta entrees, sub sandwiches, salads, pizza and desserts – along with its unlimited signature breadsticks. For more information, visit www.Fazolis.com.

MEDIA CONTACT:
Ali Lloyd, FAT Brands
alloyd@fatbrands.com
435-760-6168

Release – PDS Biotech Announces PDS0202 Elicits Active Neutralization of Multiple Influenza Strains in Preclinical Studies

Research News and Market Data on PDSB

  • PDS0202 (Infectimune® + COBRA influenza antigens) vaccination also prevented illness/weight loss
  • Vaccine protected against replication of the virus in the lungs of ferrets after challenge with the H1N1 virus
  • Data from Cleveland Clinic’s Ted Ross Lab presented at the 9th ESWI Influenza Conference

PRINCETON, N.J., Sept. 20, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced its investigational universal influenza vaccine PDS0202 demonstrated active neutralization across multiple influenza viruses. The vaccine also provided protection against infection after challenged with high doses of the H1N1 virus in ferrets not previously exposed to flu. The data were presented in an oral lecture at the 9th European Scientific Working Group on Influenza (ESWI) Conference in Valencia, Spain by James Allen, PhD, from the Cleveland Clinic laboratory of renowned influenza expert, Ted Ross, PhD.

“We are encouraged that PDS0202 has demonstrated activity in generating protective hemagglutination inhibition assay (HAI) antibody responses in pre-immune ferret studies, which are the gold standard in influenza vaccine testing. In addition to active neutralization of various influenza strains, the data demonstrated that PDS0202 prevented illness, weight loss and importantly protected the lungs of vaccinated animals from H1N1,” said Dr. Ross. “In humans, we expect PDS0202 to elicit a similar or more broadly reactive antibody profile due to humans having broader exposure to influenza and thus the recall of a more diverse population of memory B cells than the animals evaluated in our preclinical studies.”

H3N2 HAI Response


Vaccination with PDS0202 Provides broadly effective HAI antibody responses (minimum 1:40 ratio) across multiple strains of the H3N2 virus including Swtiz/13 and Kan/17 demonstrating the broad reactivity of the novel COBRA proteins.  Similar results were demonstrated against multiple strains of the H1N1 virus.
Vaccination with PDS0202 Provides broadly effective HAI antibody responses (minimum 1:40 ratio) across multiple strains of the H3N2 virus including Swtiz/13 and Kan/17 demonstrating the broad reactivity of the novel COBRA proteins. Similar results were demonstrated against multiple strains of the H1N1 virus.

H1N1 Infection Results: D3 Nasal Wash Viral Titers

PDS0202 (Y2 + NG2 COBRA proteins) prevents viral replication in the lungs of ferrets after vaccination followed by viral challenge with A/Victoria/2570/2019 H1N1 flu strain (1e6 PFU/mL).  The quantity of H1N1 virus stays below the detection limits.  The vaccine based on the wild type HA (Mich/15 + Sing/16) and the control (Mock) do not effectively prevent replication and expansion of the H1N1 virus in the lungs of the ferrets.
PDS0202 (Y2 + NG2 COBRA proteins) prevents viral replication in the lungs of ferrets after vaccination followed by viral challenge with A/Victoria/2570/2019 H1N1 flu strain (1e6 PFU/mL). The quantity of H1N1 virus stays below the detection limits. The vaccine based on the wild type HA (Mich/15 + Sing/16) and the control (Mock) do not effectively prevent replication and expansion of the H1N1 virus in the lungs of the ferrets.

PDS0202 combines PDS Biotech’s Infectimune® novel investigational immune activating platform with proprietary Computationally Optimized Broadly Reactive Antigens (COBRA) influenza antigens. The COBRA antigens developed in the laboratory of Dr. Ted Ross were designed using an in-silico layered consensus building approach, which utilizes HA sequence data from influenza surveillance databases. PDS0202’s ability to generate broad, robust antibody and T cell responses position the vaccine to potentially provide durable protection against seasonal and pandemic strains of influenza. PDS0202 is administered through intramuscular injection in a single dose.

“We are pleased that the PDS0202 data presented at the ESWI Influenza Conference are consistent with our previously reported preclinical studies in murine models, marking encouraging progress toward a potential universal influenza vaccine,” said Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech. “We look forward to our continued discussions with the National Institute of Allergy and Infectious Diseases to advance PDS0202 into clinical trials with the goal of creating a universal vaccine that provides broad protection against multiple strains of influenza.”

In previous preclinical studies, PDS0202 demonstrated the ability to promote robust induction of broadly neutralizing influenza-specific antibodies, flu-specific CD4 (helper) and CD8 (killer) T cells, as well as long-lasting memory T cells. This robust immune response to the COBRA antigens suggests strong potential for PDS0202 as a broad and long-term protecting universal influenza vaccine.

About Infectimune®
Infectimune® is a novel investigational immune activating platform that generates broad and robust antibody and T cell responses that provide durable protection against infectious disease. Infectimune® based vaccines are given by intramuscular injection and generate robust and durable protection against infectious agents in preclinical studies. Infectimune® based vaccines have demonstrated safety in preclinical studies and appear to provide more robust and longer-lasting protection against infectious disease.

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

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

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

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

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

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/322b8fdb-bf6b-4c74-96c9-81b581f74513

https://www.globenewswire.com/NewsRoom/AttachmentNg/f7fe4fb9-3936-4f2b-9673-f571604ed43

Release – Ocugen To Participate in Panel At Cantor Fitzgerald Global Healthcare Conference 2023

Research News and Market Data on OCGN

September 20, 2023

PDF Version

MALVERN, Pa., Sept. 20, 2023 (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 announced that Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-Founder of Ocugen will participate in a panel at the annual Cantor Fitzgerald Global Healthcare Conference taking place from September 26-28, 2023 in NYC.

On the panel, Dr. Musunuri will join the CEO of Tarsier Pharma to discuss their companies’ respective work toward developing novel therapies for hard-to-treat ocular diseases. In addition, members of Ocugen’s executive team will conduct one-on-one meetings with registered investors, to showcase the Company’s business and clinical development strategy across its unique gene therapy, cell therapy, and vaccine platforms, and highlight recent corporate achievements and anticipated milestones.

Details of the presentation are as follows:

Date: Tuesday, September 26, 2023
Presentation Time: 1 p.m. ET
Location: Track 1, InterContinental Barclay Hotel, New York City

A live video webcast of the fireside chat will be available on the events page of 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 Twitter and LinkedIn.

Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, 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. These and other risks and uncertainties are more fully described in our 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 
Head of Communications 
IR@ocugen.com  

Newrange Gold (NRGOF) – Advancing Toward the Creation of Pinnacle Silver & Gold Corp.


Wednesday, September 20, 2023

Newrange is focused on district-scale exploration for precious metals in the prolific Red Lake District of northwestern Ontario. The past-producing high-grade Argosy Gold Mine is open to depth, while the adjacent North Birch Project offers additional blue-sky potential. Focused on developing shareholder value through exploration and development of key projects, the Company is committed to building sustainable value for all stakeholders. Further information can be found on our website at www.newrangegold.com .

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.

Americas-focused silver-gold exploration company. In May,Newrange executed a binding Scheme Implementation Deed (SID) to acquire 100% of Mithril Resources Limited (ASX: MTH) in a reverse takeover (RTO). Pending approval by the TSX Venture Exchange, the resulting company will be named Pinnacle Silver & Gold Corp. and will be listed on the TSX Venture exchange under the symbol “PINN.” The transaction is subject to various conditions, including approval by Newrange and Mithril shareholders and by various governmental and regulatory bodies. The transaction is expected to close following the Newrange and Mithril shareholder meetings on October 5th and October 13th, respectively. Mithril would then be delisted from the ASX exchange.

Flagship project. The Copalquin gold-silver project is in Durango State, Mexico and covers an entire mining district containing several dozen historic gold and silver mines and workings. The district is within the Sierra Madre Gold-Silver Trend which extends north-south along the western side of Mexico and hosts many world-class gold and silver deposits. Based on a recent NI 43-101 compliant technical report, the El Refugio target area is estimated to contain indicated resources of 121,000 ounces of gold and 2,538,000 ounces of silver and inferred resources of 252,000 ounces of gold and 8,414,000 ounces of silver.


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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. 

The Perfect Storm Brewing in US Housing

A perfect storm is brewing in the US housing market. Mortgage rates have surged above 7% just as millennials, the largest generation, reach peak homebuying age. This collision of rising interest rates and unmet demand is causing substantial disruption, as seen in the sharp decline in home sales, cautious builders and a looming affordability crisis that threatens the broader economy.

Mortgage rates have taken off as the Federal Reserve aggressively raises interest rates to fight inflation. The average 30-year fixed rate recently hit 7.18%, according to Freddie Mac, the highest level since 2001. This has severely hampered housing affordability and demand. Fannie Mae, the mortgage finance giant, forecasts total home sales will drop to 4.8 million this year, the slowest pace since 2011 when the housing market was still recovering from the Great Recession.

Fannie Mae expects sales to struggle through 2024 as rates remain elevated. It predicts the US economy will enter a recession in early 2024, further dragging down the housing market. Home prices are also likely to drop as high rates impede sales. This could hurt consumer confidence and discretionary spending, considering the critical role housing plays in household wealth.

Higher rates have pumped up monthly mortgage payments and made homes less affordable. Take a $500,000 home purchased with a 20% down payment. At a 2.86% mortgage rate two years ago, the monthly payment would have been $1,656. With rates now at 7.18%, that same home has a monthly cost of $3,077, according to calculations by Axios. That 87% payment surge makes purchasing unattainable for many buyers.

These affordability challenges are hitting just as millennials reach peak homebuying age. The largest cohorts of this generation were born in the late 1980s and early 1990s, making them between 32 and 34 years old today. That’s when marriage, childbearing and demand for living space typically accelerate.

However, homebuilders have been reluctant to significantly ramp up construction with rates so high. Housing starts experienced a significant decline of 11.3% in August, according to Census Bureau data, driven by a decline in apartment buildings. Single-family starts dipped 4.3% to an annual pace of 941,000, 16% below the average from mid-2020 to mid-2022. Homebuilder sentiment has also plunged, according to the National Association of Home Builders.

Take a look at Orion Group Holdings Inc., a leading specialty construction company servicing the infrastructure, industrial and building sectors.

This pullback in new construction comes even as there is strong interest from millennials and other buyers. Though mortgage rates moderated the overheated housing market earlier this year, national home prices remain just below their all-time highs, up 13.5% from two years ago, according to the S&P Case-Shiller index.

Some analysts say the only solution is to significantly boost supply. But that seems unlikely with builders cautious and financing costs high. The housing crisis has no quick fix and will continue to be an anchor on the broader economy. Millennials coming of age and mortgage rates spiraling upwards have sparked a perfect storm, broken the housing market, and darkened the country’s economic outlook.

High Gas Prices Return, Complicating Inflation Fight

Pain at the pump has made an unwelcome return, with gas prices rapidly rising across the United States. The national average recently climbed to $3.88 per gallon, while some states now face prices approaching or exceeding $6 per gallon.

In California, gas prices have spiked to $5.79 on average, up 31 cents in just the past week. It’s even worse in metro Los Angeles where prices hit $6.07, a 49 cent weekly jump. Besides California, drivers in 11 states now face average gas prices of $4 or more.

This resurgence complicates the Federal Reserve’s fight against high inflation. Oil prices are the key driver of retail gas costs. With oil climbing back to $90 per barrel, pushed up by supply cuts abroad, gas prices have followed.

West Texas Intermediate crude rose to $93.74 on Tuesday, its highest level in 10 months, before retreating below $91 on Wednesday. The international benchmark Brent crude hit highs above $96 per barrel. Goldman Sachs warned Brent could reach $107 if OPEC+ nations don’t unwind production cuts.

For consumers, higher gas prices add costs and sap purchasing power, especially for lower-income families. Drivers once again face pain filling up their tanks. Households paid an average of $445 a month on gas during the June peak when prices topped $5 a gallon. That figure dropped to $400 in September but is rising again.

Politically, high gas also causes headaches for the Biden administration. Midterm voters tend to blame whoever occupies the White House for pain at the pump, whether justified or not. President Biden has few tools to immediately lower prices set by global markets.

Take a look at other energy companies by taking a look at Noble Capital Markets Research Analyst Michael Heim’s coverage list.

However, economists say oil and gas prices must rise significantly further to seriously jeopardize the U.S. economy. Past recessions only followed massive oil price spikes of at least 100% within a year. Oil would need to double from current levels, to around $140 per barrel, to inevitably tip the economy into recession, according to analysis.

Nonetheless, the energy resurgence does present challenges for the Fed’s inflation fight. While core inflation has cooled lately, headline inflation has rebounded in part due to pricier gas. Consumer prices rose 0.1% in August, defying expectations of a drop, largely because of rising shelter and energy costs.

This complicates the Fed’s mission to cool inflation through interest rate hikes. Some economists believe the energy volatility will lead the Fed to pencil in an additional quarter-point rate hike this year to around 4.5%. However, a dramatic policy response is unlikely with oil still below $100 per barrel.

In fact, some argue the energy spike may even inadvertently help the Fed. By sapping consumer spending power, high gas prices could dampen demand and ease price pressures. If energy costs siphon purchases away from discretionary goods and services, it may allow inflation to fall without more aggressive Fed action.

Morgan Stanley analysis found past energy price shocks had a “small” impact on core inflation but took a “sizable bite out of” consumer spending. While bad for growth, this demand destruction could give the Fed space to cool inflation without triggering serious economic damage.

For now, energy volatility muddies the inflation outlook and complicates the Fed’s delicate task of engineering a soft landing. Gas prices swinging upward once again present both economic and political challenges. But unless oil spikes drastically higher, the energy complex likely won’t force the Fed’s hand. The central bank will keep rates elevated as long as underlying inflation remains stubbornly high.

Klaviyo Shares Jump 23% in NYSE Debut, Providing Another Tech IPO Opportunity

Shares of marketing software firm Klaviyo jumped 23% in their trading debut Wednesday on the New York Stock Exchange. The successful initial public offering provides investors a rare opportunity to buy into a high-growth U.S. tech startup following a nearly two-year IPO drought.

Klaviyo priced its shares at $30 each, raising $345 million and valuing the company at over $9 billion on a fully diluted basis. The listing comes just a day after grocery delivery service Instacart went public on the Nasdaq after cutting its valuation target. Investor appetite for unprofitable technology names has waned in recent years amid rising interest rates.

But demand for Klaviyo shares was strong right out of the gate. For investors, IPOs provide a chance to gain exposure to emerging, innovative companies before they are available on public markets. Companies utilize IPOs to raise cash for growth and operating expenses.

Klaviyo reported revenue jumped 51% last quarter to $165 million, as its marketing automation software is now used by over 130,000 customers. The company swung to a $11 million profit last quarter after losing money a year earlier.

This transition to profitability is an attractive quality for investors who have soured on money-losing technology firms in the current environment. One major backer providing strong IPO demand is e-commerce platform Shopify, which owns around 11% of Klaviyo’s shares.

Klaviyo gets approximately 78% of its annual recurring revenue from customers who also use Shopify, indicating close ties between the two tech firms. Shopify invested $100 million into Klaviyo last year.

The marketing software provider enables companies to store customer data and build profiles to target marketing campaigns across email, text messaging, social media, and other channels. It initially focused on e-commerce companies but is now seeing growing traction in other sectors like restaurants, travel, and entertainment.

Tech IPOs ground to a halt in 2022, as surging inflation led the Federal Reserve to aggressively raise interest rates, sparking volatility and a flight from risk assets. Klaviyo is the first notable U.S. venture-backed software IPO since HashiCorp and Samsara debuted in December 2021.

The offering provides investors hungry for exposure to high-growth tech the chance to buy into a next-generation software vendor. U.S. tech IPOs slowed to their lowest level in over a decade last year. If strong demand for Klaviyo shares continues, it could open the door for more tech IPOs in 2023.

Companies that only recently considered going public may once again pursue IPOs after Klaviyo’s success. The IPO window for unprofitable tech names appeared shut, but Klaviyo’s ability to raise over $340 million shows investors still have appetite for rapidly growing software vendors.

Looking ahead, the pipeline for tech IPOs includes names like Reddit, Databricks and Discord. But many may delay plans or explore direct listings to avoid leaving money on the table like Instacart. If markets grow choppy again, Klaviyo’s offering window could close as quickly as it opened.

For now, its strong first day of trading is a boon for both the company and tech investors. Early buyers are already sitting on sizable gains from an asset class that struggled last year. If the tech IPO market thaws, it would provide investors access to the high-growth innovators driving the future.

Boston Scientific to Acquire Relievant Medsystems for $850 Million

Medical device maker Boston Scientific announced Monday it will acquire Relievant Medsystems for $850 million upfront and additional contingent payments. Relievant has developed a minimally invasive technology to treat chronic low back pain.

The deal aims to expand Boston Scientific’s portfolio in neuromodulation, the use of devices to modulate nerve activity. Relievant’s Intracept system uses targeted radiofrequency energy to ablate the basivertebral nerve, stopping pain signals from reaching the brain. It is the only FDA-cleared device specifically for vertebrogenic pain, a type of chronic back pain originating in the vertebrae.

Relievant’s system is designed to provide long-term pain relief and improve function through an outpatient procedure. It targets an estimated 5.3 million patients in the U.S. with vertebrogenic pain from degenerative disc disease or vertebral compression fractures. Boston Scientific cited Relievant’s novel technology and strong clinical data from multiple randomized controlled trials in deciding to acquire the company.

The Intracept procedure is implant-free, sparing patients from potential complications associated with implants. It also avoids destroying the intervertebral disc. The system has been used to treat over 2,000 patients since receiving FDA clearance in 2018 based on Level 1 clinical evidence.

The deal expected to close in the first half of 2024 pending approvals. Boston Scientific said Relievant is projected to generate over $70 million in sales this year with 50%+ growth in 2024. The acquisition is forecasted to be neutral or slightly accretive to Boston Scientific’s adjusted earnings per share.

“We look forward to working with the Relievant team to expand access to care for those with chronic back pain,” said Jim Cassidy, president of Neuromodulation at Boston Scientific. Both companies aim to transform the diagnosis and treatment of vertebrogenic pain through a minimally invasive approach.

Take a moment to take a look at Noble Capital Markets Senior Research Analyst Gregory Aurand’s coverage list.

U.S. National Debt Tops $33 Trillion

The U.S. national debt surpassed $33 trillion for the first time ever this week, hitting $33.04 trillion according to the Treasury Department. This staggering sum exceeds the size of the entire U.S. economy and equals about $100,000 per citizen.

For investors, the ballooning national debt raises concerns about future tax hikes, inflation, and government spending cuts that could impact markets. While the debt level itself may seem abstract, its trajectory has real implications for portfolios.

Over 50% of the current national debt has accumulated since 2019. Massive pandemic stimulus programs, tax cuts, and a steep drop in tax revenues all blew up the deficit during Covid-19. Interest costs on the debt are also piling up.

Some level of deficit spending was needed to combat the economic crisis. But years of expanding deficits have brought total debt to the highest level since World War II as a share of GDP.

With debt now exceeding the size of the economy, there is greater risk of reduced economic output from crowd-out effects. High debt levels historically hamper GDP growth.

Economists worry that high debt will drive up borrowing costs for consumers and businesses as the government competes for limited capital. The Congressional Budget Office projects interest costs will soon become the largest government expenditure as rates rise.

Higher interest rates will consume more tax revenue just to pay interest, leaving less funding available for programs and services. Taxes may have to be raised to cover these costs.

Rising interest costs will also put more pressure on the Federal Reserve to keep rates low and monetize the debt through quantitative easing. This could further feed inflation.

If interest costs spiral, government debt could eventually reach unsustainable levels and require restructuring. But well before that, the debt overhang will influence policy and markets.

As debt concerns mount, investors may rotate to inflation hedges like gold and real estate. The likelihood of higher corporate and individual taxes could hit equity valuations and consumer spending.

But government spending cuts to social programs and defense would also ripple through the economy. Leaner budgets would provide fiscal headwinds reducing growth.

With debt limiting stimulus options, creative monetary policy would be needed in the next recession. More radical measures by the Fed could introduce volatility.

While the debt trajectory is troubling, a crisis is not imminent. Still, prudent investors should account for fiscal risks in their portfolio positioning and outlook. The ballooning national debt will shape policy and markets for years to come.

Instacart Shares Surge 40% in Strong Nasdaq Debut

Instacart experienced a red-hot debut on the public markets as shares soared 40% in its first day of trading. The grocery delivery pioneer opened at $42 per share on the Nasdaq exchange, well above its IPO price of $30.

The opening trade valued Instacart at nearly $14 billion, up from the $10 billion valuation set by its IPO pricing on Monday. Demand from investors seeking exposure to the future of grocery commerce drove the shares sharply higher out of the gate.

Trading volume was heavy early on, with over 18 million shares changing hands in the first 30 minutes. The stock traded as high as $47.57 at its peak, showcasing strong appetite for the newly minted public company.

Instacart (CART) raised $420 million through the IPO by selling 14.1 million shares, representing just 8% of its total outstanding shares. Existing shareholders also sold 7.9 million shares in the offering for liquidity.

The blockbuster debut delivered significant returns for IPO participants during a volatile time for tech stocks. But Instacart’s valuation remains below the $39 billion mark it reached at the height of pandemic demand in 2021, reflecting more measured recent tech valuations.

Still, the strong first day pop is a promising sign for Instacart as it embarks on the public market journey. The company priced its offering conservatively to allow room for an impressive inaugural rally.

The offering adds Instacart to the ranks of publicly traded ecommerce innovators disrupting traditional retail models. It joins the likes of DoorDash, Uber, and Amazon in leveraging technology to unlock the potential of online grocery delivery.

Instacart is at the forefront of transforming the $1 trillion grocery industry through its on-demand digital marketplace. Its platform connects customers with personal shoppers who handle orders from partner grocers and deliver items in as fast as an hour.

Take a look at 1-800-Flowers.com, a leading ecommerce business platform that features an all-star family of brands.

Founded in 2012 by an Amazon veteran, Instacart was early to recognize the coming wave of grocery ecommerce. The company scaled rapidly when the pandemic accelerated adoption of online ordering and delivery.

Instacart seized its first-mover advantage to emerge as a leader in the space. It has partnered with prominent national, regional, and local grocers to build a retail network covering over 85% of U.S. households.

The company aligned with shifting consumer preferences for convenience and digital experiences. Busy lifestyles and smartphone ubiquity make grocery delivery a killer app of modern ecommerce.

Instacart smartly invested to expand services like fast unstaffed delivery and self-service pickup. Its Instacart Ads platform also lets brands promote products through sponsored listings.

The company rapidly grew revenue to over $7 billion in 2021 during the pandemic-driven surge. More recently it has focused on boosting profitability as demand normalizes post-Covid.

Instacart generated $14 billion in gross merchandise volume in 2021. Its net revenue neared $2 billion, doubling from 2020. But losses have narrowed dramatically since the company turned EBITDA positive last year.

As the first major tech IPO of 2023, Instacart’s trading provides a blueprint for startups and venture investors awaiting public debuts this year. The initial reception indicates persistent investor appetite for innovative tech names with strong growth narratives.

The blockbuster debut opens an exciting new chapter for Instacart and the future of digital grocery. Its first trading day validated Instacart’s pioneering business model and resilient growth prospects.

Release – ACCO Brands Publishes 2022 Environmental, Social and Governance (ESG) Report

Research News and Market Data on ACCO

09/18/2023

LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands Corporation (NYSE: ACCO) a leading global consumer, technology, and business branded products company, today published its 2022 Environmental, Social and Governance (ESG) Report.

“At ACCO Brands, we are committed to operating our business with the highest ethical standards. We foster accountability to our stakeholders with strong governance and risk management policies and practices,” noted Tom Tedford, President, and Chief Operating Officer. “Our ESG report highlights our progress in delivering on our commitments to our employees, the environment, and the communities in which we live and work. Our work is organized under the pillars of People, Planet and Products and is guided by our long-standing values: to act with integrity, embrace diversity and act responsibly in our global community,” concluded Mr. Tedford.

To access the Company’s 2022 ESG Report and learn more about the Company’s ESG efforts, read the full report by clicking here.

About ACCO Brands

ACCO Brands, the Home of Great Brands Built by Great People, designs, manufactures and markets consumer and end-user products that help people work, learn, play and thrive. Our widely recognized brands include AT-A-GLANCE®, Five Star®, Kensington®, Leitz®, Mead®, PowerA®, Swingline®, Tilibra® and many others. More information about ACCO Brands Corporation (NYSE: ACCO) can be found at www.accobrands.com.

Lori Conley
Corporate Communications
lori.conley@acco.com

Source: ACCO Brands Corporation

Release – GeoVax Next-Generation COVID-19 Vaccine Demonstrates Potent Antibody and Cellular Immunity in Immunocompromised Patients

Research News and Market Data GOVX

 

  • Last updated: 19 September 2023 13:26
  • Created: 19 September 2023 15:09
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Data Published from Phase 2 Open-Label Study of GEO-CM04S1

ATLANTA, GA, September 19, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancer, announced today the publication of data from the ongoing Phase 2 trial of its next-generation COVID-19 vaccine (GEO-CM04S1) in the journal Vaccines. The article, authored by researchers at the City of Hope National Medical Center, can be accessed here: GEO-CM04S1 Publication.

The Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024) is evaluating the safety and immunogenicity of GEO-CM04S1, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, in patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy (i.e., patients who have reduced immune system function as a result of treatment). These patients have significantly compromised immune system function and generally respond at suboptimal levels after receiving currently available COVID-19 vaccines. As such, these patients are at greater risk for developing severe disease if infected and would likely benefit from the types of immune responses induced by the GEO-CM04S1 vaccine, which are more broadly specific and include activation of both the antibody and T cell arms of the immune system.

The article, titled “Stimulation of Potent Humoral and Cellular Immunity via Synthetic Dual-Antigen MVA-Based COVID-19 Vaccine COH04S1 in Cancer Patients Post Hematopoietic Cell Transplantation and Cellular Therapy”, describes the immune response analyses conducted on the open-label portion of the Phase 2 trial, indicating that GEO-CM04S1 (referred to as COH04S1 in the article) is highly immunogenic in these immunocompromised patients, inducing potent humoral (antibody) and cellular (T cell) responses, including neutralizing antibodies against SARS-CoV-2 ancestral virus and variants of concern, including the highly immune-evasive Omicron XBB 1.5 variant.

David Dodd, GeoVax Chairman and CEO, commented, “The data presented in this publication confirm our earlier findings in healthy adults and give us confidence that we are on the right path. Protecting individuals at highest risk in our society requires next-generation vaccines, specifically with more robust immune responses, durable protection, and the ability to address continued emerging variants. The mRNA vaccines and monoclonal antibody therapies have been shown to be inadequate in providing protective immunity in such immunocompromised patients. Variants will continue to emerge, and the public health community will continue to be challenged to minimize the infection impact, thereby reducing the risk of severe disease, hospitalizations and death. Vaccines that are “variant-agnostic” such as GEO-CM04S1 will increasingly be critical to reducing such risks, protecting the most vulnerable populations and improving our ability to overcome such infectious threats.”

About GEO-CM04S1

GEO-CM04S1 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating.

In addition to the ongoing Phase 2 study in hematological cancer patients, GEO-CM04S1 is being evaluated in two other Phase 2 clinical trials:

  • As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. gov Identifier: NCT04639466. GeoVax recently announced that this trial has met its targeted patient enrollment.
  • As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.

Further underscoring the need for next-generation COVID-19 vaccines such as GEO-CM04S1, GeoVax scientists co-authored an article titled, “MVA-Vectored Universal Beta-Coronavirus Vaccine Design & Development”, published in the June 2023 issue of the online journal Vaccine Insights. The article, accessible here, provides expert insight into the emergence of SARS-CoV-2 (COVID-19), the risk of new “spillover events” from animal hosts, and how this risk can be addressed proactively. Regarding COVID-19 and its continually evolving variants, the authors describe the limitations of first-generation vaccines and the potential for MVA-vectored vaccines such as GEO-CM04S1 to overcome these limitations.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in 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. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Investor Relations Contact:

GeoVax Labs, Inc.

investor@geovax.com

678-384-7220

Media Contact:

Susan Roberts

sr@roberts-communications.com

202-779-0929

FTX Lawsuit Targets Parents of Disgraced CEO Sam Bankman-Fried

The bankrupt cryptocurrency exchange FTX has taken a surprising legal step by launching a legal battle against Allan Joseph Bankman and Barbara Fried, the parents of its former CEO and founder, Sam Bankman-Fried. The lawsuit aims to recover both luxury property and millions of dollars in what FTX alleges to be “fraudulently transferred and misappropriated funds.”

FTX, once a rising star in the cryptocurrency world, faced financial turmoil amid allegations of extensive financial misconduct. The exchange’s new leadership has been working tirelessly to locate the billions of dollars in missing assets. Their latest move is an attempt to hold Bankman and Fried accountable.

Legal representatives of the FTX bankruptcy estate assert that Allan Joseph Bankman and Barbara Fried “exploited their access and influence within the FTX enterprise to enrich themselves, directly and indirectly, by millions of dollars.” This stunning accusation suggests that Bankman and Fried might have played a significant role in the financial irregularities that led to FTX’s collapse.

One of the most notable claims in the lawsuit is that Bankman and Fried discussed transferring a $10 million cash gift and a $16.4 million luxury property in The Bahamas to their son, Sam Bankman-Fried, despite FTX’s precarious financial situation. This raises questions about whether Bankman and Fried were aware of the exchange’s dire financial straits.

The lawsuit doesn’t stop there. It also alleges that as early as 2019, Allan Bankman actively participated in efforts to cover up a whistleblower complaint that could have “exposed the FTX Group as a house of cards.” The lawsuit cites emails written by Bankman in which he complained about his annual salary being only $200,000 when he believed he was “supposed to be getting $1M/yr.” The suit portrays this as Bankman lobbying his son to significantly increase his own salary.

Take a look at Bit Digital Inc., a sustainability focused generator of digital assets, that has a large-scale bitcoin mining business with operations across the U.S. and Canada.

Shockingly, within two weeks of these discussions, the suit claims that Sam Bankman-Fried collectively gifted his parents $10 million in funds from Alameda. Within three months, Bankman and Fried were deeded the $16.4 million property in The Bahamas. The timing and circumstances of these transactions raise serious questions about their legality and ethical implications.

Moreover, the lawsuit alleges that Bankman-Fried’s parents urged substantial political and charitable contributions, including significant amounts to Stanford University, seemingly aimed at enhancing Bankman and Fried’s professional and social status. Barbara Fried is also accused of encouraging her son and others within the company to avoid or even violate federal campaign finance disclosure rules by engaging in straw donations or concealing the FTX Group as the source of the contributions.

The involvement of Bankman-Fried’s parents in these activities is particularly noteworthy. Both are accomplished legal scholars who have taught at Stanford Law School. Barbara Fried specializes in ethics, while Allan Bankman’s expertise is in taxes. Their involvement in the alleged misconduct at FTX raises questions about their awareness of the situation and their potential role in enabling it.

Sam Bankman-Fried himself is independently facing multiple wire and securities fraud charges related to the alleged multibillion-dollar FTX fraud. Federal prosecutors and regulators have accused him of orchestrating “one of the biggest financial frauds in American history.” Bankman-Fried has maintained his innocence and pleaded not guilty to all charges. His criminal trial is scheduled to commence on October 3 in Manhattan.

The lawsuit against Bankman and Fried asserts that they “either knew or ignored bright red flags revealing that their son, Bankman-Fried, and other FTX Insiders were orchestrating a vast fraudulent scheme.” This suggests that FTX believes the parents played a more significant role in the alleged fraud than previously thought.

In their legal action against Bankman and Fried, FTX seeks various forms of compensatory relief, including punitive damages. The exchange aims to hold them accountable for their alleged “conscious, willful, wanton, and malicious conduct” that contributed to FTX’s financial woes. Additionally, FTX is looking to recover any property or payments made to the couple from the exchange.

The outcome of this legal battle remains uncertain, and it raises questions about how any potential clawbacks may affect Bankman and Fried’s ability to support their son’s legal defense as he faces criminal charges. The legal counsel for Allan Joseph Bankman and Barbara Fried has vehemently denied the allegations, characterizing them as “completely false.” They view FTX’s legal action as an attempt to intimidate their clients and undermine the upcoming trial of their child.

Take a a moment to look at Bitcoin Depot Inc., a company that enables users to convert cash to Bitcoin at kiosks located in thousands of name-brand retail locations across North America.

The implications of this legal showdown extend beyond the immediate parties involved. FTX’s efforts to recover lost assets and hold those responsible accountable are a crucial chapter in the cryptocurrency industry’s ongoing struggle with regulatory scrutiny and legal challenges. The outcome of this case may set a precedent for how authorities and stakeholders deal with alleged fraud and financial misconduct in the rapidly evolving world of cryptocurrencies.

As the legal battle unfolds, it will be closely watched by industry observers, legal experts, and cryptocurrency enthusiasts alike. The allegations and accusations against the parents of Sam Bankman-Fried have added another layer of complexity to a case that has already drawn significant attention and could have far-reaching consequences for the cryptocurrency ecosystem.