Kelly Services (KELYA) – Selling International Staffing Business


Friday, November 03, 2023

Kelly (Nasdaq: KELYA, KELYB) connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We’re always thinking about what’s next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 350,000 people around the world and connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice. Revenue in 2021 was $4.9 billion. Visit kellyservices.com and let us help with what’s next for you.

Joe Gomes, 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.

Selling A Piece. Kelly Services is selling its European Staffing Business to Gi Group Holdings S.P.A. The sale is for cash consideration of €100 million (about $106 million at current exchange rates) with a €30 million earnout based on a multiple of adjusted 2023 EBITDA and payable in 2Q24. The transaction is expected to close in 1Q24.

But Not All. The deal includes Kelly’s European Staffing business across 14 European countries. Notably, Kelly will maintain its global footprint and continue to provide higher margin, higher growth potential MSP, RPO, and FSP solutions to customers in the EMEA region through KellyOCG. As a leading global vendor-neutral provider of talent supply chain strategies and workforce solutions, KellyOCG leverages a network of 3,000 suppliers – including Gi – spanning 140 countries to connect customers across North America, Asia Pacific, and EMEA with top talent.


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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. 

Information Services Group (III) – Reports Results and an Acquisition


Friday, November 03, 2023

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 700 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,300 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For additional information, visit www.ISG-One.com

Joe Gomes, 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.

3Q Results. ISG reported third quarter revenue of $71.8 million, a record for the quarter, although lower than management’s $73-75 million guidance and our estimate of $75 million. Revenue was up 4.3% from last year’s $68.8 with currency translation positively impacting reported revenues by $1.4 million versus the prior year. Revenues from Americas were up 1% to $42.5 million from the prior year, Europe up 14% to $22.1 million, and Asia Pacific down 2% to $7.2 million. Recurring revenue was up 19% in the quarter.

Bottom Line. Net income for the quarter was $3.2 million, or diluted EPS of $0.06, down 42% from $5.6 million last year, or $0.11. We estimated net income of $3.8 million, or EPS of $0.08. Non-GAAP net income was $5.7 million, or diluted EPS of $0.11, compared to $7.2 million, or $0.14, last year. Adjusted EBITDA was $10.6 million, flat with last year, near the low-end of management’s $10.5-$11.5 million guidance.


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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. 

Eskay Mining Corp. (ESKYF) – Observations from the 2023 Diamond Drill Program


Friday, November 03, 2023

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.

Productive drill season. Eskay Mining had a productive 2023 diamond drill and exploration season at its 100% controlled Consolidated Eskay Gold Project. The roughly 6,000 meter drill program centered on seven targets: 1) Cumberland, 2) Scarlet Knob-Bruce Glacier, 3) Tarn Lake, 4) Hexagon-Mercury, 5) Maroon Cliffs, 6) Storie Creek, and 7) TV South. While the company confirmed new precious metal rich volcanogenic massive sulfide (VMS) discoveries, the most significant outcome, in our view, is that the program highlighted the significant exploration potential in the areas between the Cumberland target and the TV-Jeff complex. Tied for second are results from Scarlet Knob and Tarn Lake.

Encouraging results at Cumberland. Cumberland is ~6 kilometers south of the TV deposit and is similarly situated along the east side of the Eskay anticline. Nine holes were completed at the Cumberland target. Several returned promising assays, including Hole CBL23-28 which returned 3.02 grams of gold per tonne, 68.66 grams of silver per tonne, 0.24% copper, 0.74% lead, and 4.86% zinc, or 6.28 grams of gold equivalent, over 15 meters.


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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. 

Entravision Communications (EVC) – A Tempered, But Still Favorable View


Friday, November 03, 2023

Entravision Communications Corporation is a diversified Spanish-language media company utilizing a combination of television and radio operations to reach Hispanic consumers across the United States, as well as the border markets of Mexico. Entravision owns and/or operates 53 primary television stations and is the largest affiliate group of both the top-ranked Univision television network and Univision’s TeleFutura network, with television stations in 20 of the nation’s top 50 Hispanic markets. The Company also operates one of the nation’s largest groups of primarily Spanish-language radio stations, consisting of 48 owned and operated radio stations.

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

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

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

A mixed quarter. Q3 revenues of $274.4 million, a record revenue quarter for the company, was largely in line with our $277.0 million estimate. But, the absence of high margin Political advertising and lower margin revenue mix caused an adj. EBITDA shortfall, $14.2 million versus our $17.0 million estimate. Lower Digital adj. EBITDA accounted for the largest portion of the EBITDA variance. 

Lower Q4 outlook. We are lowering our Q4 total company revenue from $318.0 million to $309.7 million to reflect the company’s current pacings. Based on lower margin assumptions, we are lowering our adj. EBITDA from $25.0 million to $19.0 million. For the year, we are lowering our adj. EBITDA estimate from $69.2 million to $60.4 million. 


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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. 

Eledon Pharmaceuticals (ELDN) – Phase 1b Data Shows Safety With An Important Improvement In Kidney Function


Friday, November 03, 2023

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.

Update From Phase 1b Trial Presented. Eledon presented updated data from its Phase 1b open-label trial testing tegoprubart for prevention of kidney transplant rejection. The data showed tegoprubart was comparable or better than tacrolimus in safety and tolerability, its primary endpoint. One of the secondary endpoints measuring kidney function showed a substantial improvement over tacrolimus. We see this data as a strong positive for tegoprubart.

Tegoprubart Is In Development To Replace Tacrolimus. The calcineurin inhibitor tacrolimus is the current standard of care for preventing transplant rejection. It has a success rate of over 90% first year graft survival, but its side effects include toxicity to the kidney and pancreas. These toxicities cause new onset diabetes and graft failure. The open-label trial tested a regimen with tegoprubart instead of tacrolimus along with the other standard-of-care drugs. 


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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. 

ACCO Brands (ACCO) – First Look into a Mixed Third Quarter


Friday, November 03, 2023

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

Joe Gomes, 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.

A Mixed Bag. ACCO’s 3Q23 results were a mixed bag. Global macroeconomic weakness, softer technology accessories product demand, and a stronger U.S. dollar negatively impacted 3Q23 top line. But gross margin improved by 400 basis points, reflecting the continued recovery of margin from pricing actions, as well as cost savings from the Company’s restructuring and footprint rationalization efforts.

3Q23 Results. Net sales for the quarter declined 7.7% to $448.0 million from $485.6 million last year. We had estimated sales of $475 million. Comparable sales fell 9.9%. Net income was $14.9 million, or $0.15 per share, compared to a net loss of $68.7 million, or $0.73, last year. Last year was impacted by a goodwill impairment charge, partially offset by higher restructuring and income tax expense in the current year. Adjusted net income was $23.1 million, or $0.24, compared to $24.1 million, or $0.25, last year.


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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. 

1·800·Flowers.com, Inc. (FLWS) – Off To A Good Start


Friday, November 03, 2023

For more than 45 years, 1-800-Flowers.com has offered truly original floral arrangements, plants and unique gifts to celebrate birthdays, anniversaries, everyday occasions, and seasonal holidays, and to deliver comfort during times of grief. Backed by a caring team obsessed with service, 1-800-Flowers.com provides customers thoughtful ways to express themselves and connect with the most important people in their lives. 1-800-Flowers.com is part of the 1-800-FLOWERS.COM, Inc. family of brands. Shares in 1-800-FLOWERS.COM, Inc. are traded on the NASDAQ Global Select Market, ticker symbol: FLWS.

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

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

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

Fiscal Q1 results better than expected. Total company revenues of $269.1 million, which declined 11.4% from a year earlier, beat our estimate of $249.9 million, driven by better results in each of its operating segments. The revenue decrease represented a significant moderation from the 17.9% decline in its fiscal Q4. The seasonal adj. EBITDA loss of $22.0 million was better than our loss estimate of $27.8 million. 

Improving margin outlook still favorable. Gross margins in the latest quarter improved 450 basis points from 33.4% to 37.9% due to lower ocean freight costs, moderating commodity prices, and lower inventory write-offs. While ocean freight prices have returned to near pre-Covid levels, there is still significant margin expansion opportunities as commodity prices moderate. We anticipate that full fiscal year 2024 gross margins should improve from 37.5% in 2023 to 39.3% in 2024.


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

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

Sam Bankman-Fried Found Guilty on All Counts in FTX Fraud Trial

Sam Bankman-Fried, the disgraced founder and former CEO of the failed cryptocurrency exchange FTX, has been found guilty on all charges related to fraud and money laundering. The verdict was handed down on Thursday by a jury in a Manhattan federal court following over a month of dramatic testimony in one of the most high-profile white collar criminal trials in recent history.

Bankman-Fried faced seven criminal counts tied to allegations he defrauded FTX customers and investors out of billions of dollars. The jury deliberated for approximately four hours before returning guilty verdicts on all counts, affirming the prosecution’s allegations that the 30-year-old knowingly misled investors and misappropriated customer deposits to cover losses at his hedge fund, Alameda Research.

Each fraud count carries a maximum sentence of 20 years in prison, while the money laundering conviction includes up to another 20 years. This brings the total maximum sentence to 115 years behind bars for Bankman-Fried. His sentencing hearing is scheduled for March 2024, where the exact prison term will be determined by Judge Lewis Kaplan.

Rapid Downfall of a Crypto Pioneer

The verdict represents a dramatic demise for Bankman-Fried, who was once hailed as a pioneer within the crypto industry. The MIT graduate founded FTX in 2019, and it grew rapidly to become one of the largest global cryptocurrency exchanges with a valuation of over $30 billion at its peak.

But FTX collapsed almost overnight last November after a report revealed a leaked balance sheet showing Alameda Research owed billions of dollars in loans to FTX. The news triggered a liquidity crisis and customer withdrawals that quickly bankrupted both companies.

Prosecutors presented evidence over the course of the trial that Bankman-Fried had secretly transferred customer funds from FTX to cover losses at Alameda as the hedge fund made a series of failed investments. In total, an estimated $8 billion in customer money vanished.

When asked on the witness stand whether he stole funds, Bankman-Fried testified “I never intended to commit fraud.” But the 12-person jury ultimately sided with the prosecution in deeming his actions fraudulent.

Watershed Moment for Crypto Accountability

The guilty verdict represents a major victory for authorities seeking greater accountability within the largely unregulated crypto industry. Bankman-Fried’s conviction on all criminal charges related to the FTX collapse will likely spur further calls for regulation to protect investors participating in digital asset markets.

Many Industry observers believe the prosecution and ultimate guilty verdict for Bankman-Fried will serve as a warning for other crypto executives. His undoing may deter similar misconduct, as leaders now know they can face severe criminal repercussions for defrauding customers.

While the FTX saga damaged trust in cryptocurrencies broadly, the decisive guilty verdict helps restore some faith that justice can be served. Investors who lost their savings when FTX failed may find some solace knowing its founder and chief architect will now likely serve substantial prison time.

For Bankman-Fried himself, the future now looks increasingly bleak. His sentencing in March 2024 will determine exactly how many years he’ll spend incarcerated for the crimes that led to FTX’s epic collapse and wiped out billions in customer funds. But the outcome is already clear – his fraud conviction ensures Bankman-Fried will go down in history as a disgraced figure instead of the visionary entrepreneur he once portrayed himself to be.

Forum Energy Technologies Transforms Business with Variperm Acquisition

Houston-based Forum Energy Technologies (NYSE: FET) announced a definitive agreement to acquire Variperm Energy Services in a transformative $210 million deal. The acquisition is expected to significantly boost FET’s revenues, profitability, and exposure to critical global energy production.

Under the terms of the agreement, FET will pay $150 million in cash and issue 2 million shares of FET common stock to acquire Variperm. This reflects a total valuation of approximately 3.7 times Variperm’s trailing 12-month EBITDA. The deal is projected to close in January 2024, subject to customary closing conditions and Canadian regulatory approval.

Variperm is a leading manufacturer of customized downhole solutions and sand/flow control products for heavy oil applications. Headquartered in Calgary, Canada, the company has 290 employees across eight North American locations. Variperm has been backed by private equity firm SCF Partners since 2014.

“We are excited to have Variperm join the FET family,” said Neal Lux, President and CEO of FET. “Variperm’s differentiated technology and strong position with blue-chip customers establishes FET as a key global partner for producers.”

Significantly Accretive Deal

FET expects the acquisition to be highly accretive, transforming its profitability, margins and scale.

On a combined trailing 12-month basis as of September 30, 2023, FET projects total revenues increasing 17% to $873 million. Adjusted EBITDA is expected to surge 77% to $121 million, reflecting a 470 basis point improvement in EBITDA margins to 14%.

The deal is also expected to drive substantial increases in operating cash flow, free cash flow, and earnings per share. FET anticipates ample liquidity and balance sheet flexibility even after closing, with net leverage of only 1.9x EBITDA.

Complementary Offerings & Global Reach

Importantly, Variperm’s product portfolio directly complements FET’s existing artificial lift and downhole solutions. This creates cross-selling opportunities and enables FET to offer integrated solutions.

FET can also leverage its extensive global infrastructure and footprint spanning over 50 countries to expand Variperm’s customer reach worldwide. This includes critical energy markets in the Middle East.

Neal Lux commented, “Variperm’s strong position with blue-chip customers further establishes FET as a key global partner for producers. The acquisition also broadens FET’s exposure to one of the most critical sources of global energy production and security.”

Financing & Liquidity

FET plans to fund the $150 million cash portion of the acquisition through existing cash on hand and borrowings under its revolving credit facility. FET may also utilize a $60 million seller term loan from Variperm’s existing PE owners.

In conjunction with the deal, FET has amended its credit facility to increase revolving commitments by $71 million to $250 million. The amended facility also extends maturity to September 2028 and permits the Variperm acquisition.

At close, FET expects to have net leverage of 1.9x EBITDA and liquidity of approximately $142 million to fund operations and future growth. The company anticipates rapidly deleveraging to 1.0-1.3x by end of 2024 based on free cash flow generation.

The strategic Variperm acquisition solidifies FET’s standing as a leading provider of solutions for the global oil & gas industry. By augmenting its portfolio, boosting profitability, and expanding its customer base, FET has set the stage for continued growth and success.

Take a moment to look at other energy companies by looking at Noble Capital Market’s Senior Research Analyst Michael Heim’s coverage list.

Release – Onconova Therapeutics’ ASH Poster To Focus On Narazaciclib In MCL

Research News and Market Data on ONTX

Nov 02, 2023

PDF Version

Preclinical data indicate that narazaciclib shows monotherapy and combination anti-tumor activity in ibrutinib-sensitive and resistant cells and xenograft models

NEWTOWN, Pa., Nov. 02, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Onconova and collaborators will present a preclinical poster related to its lead program, narazaciclib, at the 65th American Society for Hematology Annual Meeting & Exposition (ASH), taking place in San Diego, California from December 9 to 12, 2023.

“The poster that we and researchers from the Josep Carreras Leukaemia Research Institute in Barcelona, Spain are presenting at ASH 2023 shows that the study of narazaciclib, either as a single agent or in combination with ibrutinib, effectively controls tumor growth in preclinical models of mantle cell lymphoma (MCL), including those that are resistant to Bruton’s tyrosine kinase inhibitors (BTKis), a mainstay of care for this aggressive and difficult to treat cancer. The experiments included a broad comparison of narazaciclib with three other approved cyclin-D-kinase inhibitors (CDKis), used in combination with several BTKis,” said Steven Fruchtman, M.D., President and CEO of Onconova.

Dr. Fruchtman continued, “We were especially pleased by the broad translational data set that provided an understanding of narazaciclib’s role in cell cycle blockade. These studies show that narazaciclib appears to act in the G1 phase of the cell cycle. Furthermore, the studies also indicate that the combination of narazaciclib and ibrutinib act in a synergistic way to achieve in vitro and in vivo anti-tumor activity in ibrutinib sensitive- and resistant -cells and xenograft models. Together, these data support the potential use of narazaciclib in MCL and other cyclin-dependent indications, and further inform our understanding of narazaciclib’s mechanism of action as we advance the clinical program, led by the Phase 1/2a study in patients with low grade endometrioid endometrial cancer, an indication with a great unmet medical need.”

Poster Presentation Information:

Title: Narazaciclib, a Differentiated CDK4/6 Antagonist, Prolongs Cell Cycle Arrest and Metabolomic Reprogramming, Enabling Restoration of Ibrutinib Sensitivity in Btki-Resistant Mantle Cell Lymphoma
Session Name: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster III
Session Date: Monday, December 11, 2023
Presentation Time: 6:00 PM – 8:00 PM PT
Location: San Diego Convention Center, Halls G-H
Poster Number: 4181 
Presenters: Dr. Nuria Profitos-Peleja, Lymphoma Translational Group, Josep Carreras Leukaemia Research Institute, Barcelona, Spain

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company’s product candidates, narazaciclib and rigosertib, are proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Narazaciclib, Onconova’s novel, multi-kinase inhibitor (formerly ON 123300), is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole, in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova believes narazaciclib has broad potential and is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications, including breast cancer.

Rigosertib is being studied in an investigator-sponsored trial strategy to evaluate the product candidate in multiple indications, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).

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

Forward Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com 

Biden Taps Historic Amounts of Emergency Reserve Oil to Fight Prices – But Will it Work?

In a bold move to combat surging fuel prices and rampant inflation, President Biden is unleashing a flood of black gold onto the markets. The White House is planning to tap a massive 180 million barrels of crude oil from the nation’s Strategic Petroleum Reserve (SPR) – the biggest withdrawal in the reserve’s history.

The news sent oil prices tumbling 5% in early trading as speculators reacted to the supply boost. But will the SPR floodgates really succeed in taming the oil price beast that has economists worried about recession?

The sheer size of the release, equivalent to two full days of global oil consumption, grabbed headlines. Set to be gradually emptied over several months, Biden’s SPR unleashing is meant to act like a shot of bear tranquilizer for the raging oil market.

Ever since Russia’s invasion of Ukraine, reduced supply from the world’s No. 2 exporter combined with surging demand has driven prices to their highest levels since 2008. Brent crude already flirted with a mind-boggling $140 per barrel in March. Even after the SPR news-driven dip, benchmark oil remains stubbornly high at around $105.

For Biden, doling out the emergency crude is a midterm elections Hail Mary pass. Painfully high gas prices have contributed to the president’s dismal approval ratings. Tapping the SPR to lower fuel costs may be his best bet to avoid Democrats enduring a disastrous drubbing by the Republicans in November.

Beyond politics, uncorking America’s oil reserves also sends an important message to the market. It signals the Administration’s determination to fight an inflation rate that keeps printing four-decade highs. Few things impact inflation expectations like changes in oil prices. A meaningful drop could help tamp down the runaway price increases eroding consumer confidence.

But will the effort succeed or will it flounder like past attempts? With global crude inventories at historic lows, many analysts see the SPR release as a mere band-aid solution. It provides some short-term relief but doesn’t fix the supply and demand imbalance.

Goldman Sachs estimates the 180 million barrel slug will help rebalance markets this year. But it warned the move doesn’t resolve the structural deficit caused by excluding Russian exports.

Previous SPR releases also failed to produce lasting effects. Oil prices quickly rebounded after 60 million barrels were tapped in November 2021 and another 30 million in March 2022.

This time, the White House is also counting on allies for help. The International Energy Agency meets soon to potentially coordinate a collective release from its members’ reserves.

But Biden’s SPR gambit already seems at odds with other moves meant to restrict oil supply and fight climate change. Canceling the Keystone XL pipeline permit and banning new federal drilling auctions counterproductively worsened the supply crunch. A of couple million extra daily barrels from those sources would have eased pressure on prices.

The Administration now finds itself trying to fix with one hand problems partly created by the other. That internal tension undermines the large SPR release’s credibility.

Traders also scoffed when OPEC refused to boost production more than a token amount after the U.S. lobbied for extra output. With the cartel and allies like Russia benefitting handsomely from $100+ oil, they have little incentive to pump much more.

Meanwhile, risks of a demand-killing recession loom if the Fed’s inflation fight requires jumbo interest rate hikes. And Covid lockdowns in China already hurt oil demand in the world’s largest importer.

So while Biden’s SPR flow should offer some near-term relief at the pump, it may not move the needle much for long. Markets fear what happens if 180 million barrels merely postpones the supply day of reckoning rather than preventing it.

With inventories low, spare capacity shrinking, geopolitical unrest continuing, and ESG considerations constraining investment, oil looks poised to remain highly volatile. While the SPR release was historic in size, it likely won’t fully tranquilize the energy markets.

Take a moment to take a look at Noble Capital Markets’ Senior Research Analyst Michael Heim’s Energy Industry Report.

Release – Eledon Reports Updated Data from Ongoing Phase 1b Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation

Research News and Market Data on ELDN

November 2, 2023

PDF Version

Data from 11 participants demonstrates tegoprubart successfully prevented kidney transplant rejection and was generally safe and well-tolerated

Aggregate mean eGFR was above 70 mL/min/1.73m2 at all reported time points after day 90 supporting tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation

Eledon will host a conference call today at 5:00 p.m. ET

IRVINE, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported results from the Company’s ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of rejection in patients undergoing de novo kidney transplantation. Results were presented at the American Society of Nephrology Kidney Week 2023 Annual Meeting taking place in Philadelphia, PA from November 2-5, 2023.

“We are excited to present updated safety and efficacy results from our ongoing Phase 1b trial which continue to support the potential of tegoprubart as a novel kidney transplant immunosuppressive therapy to prevent rejection and better preserve organ function without many of the side effects associated with tacrolimus, the current standard of care,” said David-Alexandre C. Gros, M.D., Chief Executive Officer. “We remain committed to the transplant community who are in urgent need of better treatment options, and we look forward to continuing this study in parallel with our Phase 2 BESTOW study initiated earlier this year.”

At the time of data submission, results from the 11 participants in the Phase 1b trial demonstrated that tegoprubart is generally safe and well-tolerated in patients undergoing kidney transplantation. There have been no cases of hyperglycemia, new onset diabetes, tremor, or cytomegalovirus infection commonly seen with tacrolimus. One participant experienced a mild T cell mediated rejection (Banff score 1a) on day 99. This patient was treated for the rejection and remains in the study. There were no cases of graft loss or death.

Aggregate mean estimated glomerular filtration rate (eGFR) – a measure of kidney function – was above 70 mL/min/1.73m2 at all reported time points after day 90. Historical studies have reported average eGFRs generally in the low 50 mL/min/1.73m2 range during the first year after kidney transplant using standard of care. One participant has completed the study with an eGFR of 91 at one year (day 374) and is now enrolled in a Phase 2 open-label extension (OLE) study, which will evaluate the long-term safety, pharmacokinetics, and efficacy of tegoprubart in participants who have completed one year of treatment in either the ongoing Phase 1b or Phase 2 BESTOW study.

“In this Phase 1b trial, patients treated with tegoprubart demonstrated robust improvements in eGFR with a strong safety profile,” said Dr. John S. Gill, MD, Professor of Medicine at the University of British Columbia, St. Paul’s Hospital, Vancouver, Canada, and Principal Investigator of the study. “These results further support the promise of CD40L costimulatory blockade in organ transplantation. I look forward to additional readouts from this study in 2024.”

The Phase 1b open-label study has enrolled 11 participants who underwent kidney transplantation in Canada, Australia, and the United Kingdom. Each participant received rabbit antithymocyte globulin (ATG) induction and a maintenance regimen consisting of tegoprubart, mycophenolate mofetil, and corticosteroids. The primary endpoint of the study is safety. Other endpoints include characterizing the pharmacokinetic profile of tegoprubart, the incidence of biopsy proven rejection, and eGFR.

In September, Eledon announced that the first participant had been dosed in the Company’s Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. The multicenter, two-arm, active comparator clinical study is enrolling approximately 120 participants undergoing kidney transplantation in the United States and other countries to evaluate the safety, pharmacokinetics, and efficacy of tegoprubart compared to the calcineurin inhibitor tacrolimus. The BESTOW trial’s primary endpoint is designed to test the potential superiority of tegoprubart vs. tacrolimus in post kidney transplant kidney function at 12 months as measured by eGFR. The Company expects to complete enrollment at the end of 2024.

Full details on the poster presentations are below:

Title: Tegoprubart for the prevention of rejection in kidney transplant: update of emerging data from an ongoing trial
Presenter: Steve Perrin, Ph.D., President and Chief Scientific Officer, Eledon Pharmaceuticals
Poster Number: TH-PO835
Session Title: Transplantation: Clinical – I [PO2102-1] 
Session Date and Time: November 2, 2023 from 10:00 AM to 12:00 PM EDT

Following the presentation, a copy of the poster will be available on the Investor section of the Company’s website at https://ir.eledon.com/news-and-events/publications-and-presentations

Conference Call

Eledon will hold a conference call today, November 2, 2023 at 5:00 p.m. Eastern Time to discuss the updated trial results. The dial-in numbers are 1-888-886-7786 for domestic callers and 1-416-764-8658 for international callers. The conference ID is 66816567. A live webcast of the conference call will be available on the Investor Relations section of the Company’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedInTwitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals 

Release – Tonix Pharmaceuticals’ Vaccine Candidate, TNX-1800, Selected by NIH/NIAID Project NextGen for Inclusion in Clinical Trials

Research News and Market Data on TNXP

November 02, 2023 8:00am EDTDownload as PDF

NIAID is conducting early phase clinical trials on select next generation COVID-19 vaccine candidates with the intent to identify promising vaccine candidates

TNX-1800, a live virus percutaneous vaccine candidate, is based on Tonix’s recombinant pox virus (RPV) platform

Phase 1 clinical trial of TNX-1800 expected to start in the second half of 2024

NIAID will cover the full cost of the clinical trial; Tonix will supply the vaccine candidate

CHATHAM, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), will conduct a Phase 1 clinical trial with TNX-1800 (recombinant horsepox virus, live vaccine),1 Tonix Pharmaceuticals’ vaccine candidate to protect against COVID-19.

Tonix is developing a novel vaccine platform initially targeting COVID-19, smallpox and mpox (monkeypox). 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 tolerated2 and showed promise in protecting animals from challenge with SARS-CoV-2 delivered directly into the lungs.3 A related horsepox-based vaccine, TNX-8011, protected animals against challenge with monkeypox virus delivered directly into the lungs.4 TNX-801 is also the vector on which TNX-1800 is based and has been shown to be >1,000-fold more attenuated than modern vaccinia virus vaccine (VACV) strains in immunocompromised mice.5 The Phase 1 trial of TNX-1800 is expected to start in the second half of 2024. NIAID will study TNX-1800 by percutaneous administration.

“We believe our novel vaccine platform technology has the potential to provide durable protection from respiratory pathogens and slow their spread,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-1800 will be the first vaccine candidate using our live virus recombinant pox virus (RPV) platform technology to enter clinical trials. We hope to expand the portfolio of RPV-based vaccines to address several other known respiratory threats including smallpox, mpox and tuberculosis. We are committed to supporting NIAID in assembling a variety of vaccine platform options to ensure the availability of effective vaccines in the face of known and emerging threats. We look forward to participating in the Project NextGen initiative.”

“Project NextGen,” is an initiative by the U.S. Department of Health and Human Services (HHS) to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19. NIAID will be conducting clinical trials to evaluate several early-stage vaccine candidates. The Phase 1 study involving TNX-1800 is designed to assess safety and immunogenicity in approximately 60 healthy adult volunteers. Upon completion of the trial, NIAID and Tonix Pharmaceuticals will assess the results and determine the next steps for the development of TNX-1800.

NIAID will cover the full cost of the clinical trial, including operations and related analysis. Tonix will be responsible for providing clinical trial materials, and upon completion will have the right to rely on the findings in regulatory filings with the U.S. Food and Drug Administration (FDA) to support the approval of its COVID-19 vaccine and other vaccines based on the RPV platform.

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 will 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-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. The RPV platform is based on a horsepox vector, which is a live replicating, attenuated virus that has been shown to be >1,000-fold more attenuated than modern VACV strains in immunocompromised mice.5 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. 6-9 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.4,6 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. Moreover, we believe the low dose of TNX-1800 makes this technology amenable for future implementation in microneedle delivery systems.

About TNX-801*
TNX-801 (recombinant horsepox virus) is a live virus vaccine based on horsepox4-7 in pre-clinical development to prevent smallpox and mpox. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with monkeypox.Tonix has received official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-801 as a potential vaccine to protect against mpox disease and smallpox.10 Tonix believes the FDA feedback provides a path to agreement on the design of a Phase 1 /2 study and the overall clinical development plan. The Phase 1/2 clinical trial will assess the safety, tolerability, and immunogenicity of TNX-801, following the submission and clearance of an IND. More than 30,000 people have contracted mpox in the U.S. so far during the 2022-23 epidemic,11 The recent cluster of mpox in Chicago revealed breakthrough cases of mpox in individuals who had been vaccinated with the currently authorized non-replicating vaccine, which is administered in two doses.12 In contrast, TNX-801 is delivered percutaneously with only one dose and therefore may achieve higher rates of community protection by eliminating drop-out between doses and limiting forward transmission. Moreover, relying on only one approved mpox vaccine at present is a risk for the global supply chain that has already led to insufficient availability of vaccines to meet global health needs, especially in Africa. TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment for chronic migraine, and enrollment has been completed in a Phase 2 proof-of-concept study with topline data expected in early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the fourth quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

*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. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are property of their respective owners.

1 TNX-1800 and TNX-801 are experimental new vaccines and have not been approved for any indication.
2 Awasthi, M. et al. Viruses. 2023. 15(10):2131.
3 Awasthi, M. et al. BioRxiv. 2023.
4 Trefry S, et al. BioRxiv. 2023.
5 Noyce RS, et al. Viruses. 2023. 15(2):356.
6 Jenner E. “An Inquiry Into the Causes and Effects of the Variole Vaccinae, a Disease Discovered in Some of the Western Counties of England, Particularly Gloucestershire and Known by the Name of the cow‐pox.” London: Sampson Low, 1798.
7 Noyce RS, et al. PloS One. 2018. 13(1):e0188453.
8 Schrick L et al. N Engl J Med. 2017. 377:1491-1492.
9 Tulman ER, et al. J Virol. 2006. 80(18):9244-58.
10 TNX-801 PR pre-IND meeting August 20, 2023: https://ir.tonixpharma.com/news-events/press-releases/detail/1417/tonix-pharmaceuticals-announces-results-of-pre-ind-meeting
11 McQuiston JH, et al. MMWR Morb Mortal Wkly Rep. 2023. 72:547–552.
12 Centers for Disease Control. MMWR Morb Mortal Wkly Rep. 2023. 72(25);696-698.

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

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

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

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released November 2, 2023