Spirit Airlines still positioned to fly you home for the holidays despite financial turbulence, observers say

 

By David Lyons
November 3, 2024

One would think that less than a month before Thanksgiving, and two months before the Christmas-New Year’s holiday season, this is not an ideal time for news pages to be filled with reports about an airline’s possible bankruptcy filing, or renewed takeover talk by an old suitor, or a spate of layoffs looming in January.

But the public discussion is one of the realities facing South Florida-based Spirit Airlines as the carrier’s management labors to raise cash and plot a course to return to profitability amid fierce industry competition.

Travelers have choices when they book trips for the year’s busiest travel seasons. As Spirit alters its route network, sells airplanes, cuts capacity and arranges hundreds of furloughs as part of an $80 million cost-cutting program, customers would like to know whether they will be facing changes in their plans.

“I think Spirit is going to do everything possible to minimize disruptions to its customers for the holidays,” said Henry Hartveldt, founder and president of Atmosphere Research Group, an industry consultancy in San Francisco. “One challenge Spirit faces is unfortunately there is a lot of bad news swarming around the airline, and that inspires concern among travelers.”

Spirit, which publicly acknowledged Thursday another round of 330 furloughs among its pilot ranks planned for January, was less clear when asked if the airline plans any route changes that might impact the forthcoming holidays, and whether customers would be notified in advance.

“We don’t have any route adjustments to share at this time,” a spokesman replied by email.

In 2023, Spirit was the leader in passengers carried at Fort Lauderdale- Hollywood International Airport, whose annual report placed the discount airline’s share at 29%, or more than 9.8 million travelers using the Broward County airport. JetBlue Airways was second at 20% and Southwest Airlines third at 14%.

“We are a month away from Thanksgiving,” Harteveldt said. “I don’t think we are going to see Spirit make any major changes to the Thanksgiving schedule. If bookings are strong enough I expect the airline will fly the flights scheduled for the Christmas and New Year’s period as well.”

Ivan Reich, a lawyer who lives in West Palm Beach, said he remains a fan of Spirit for its low prices. Asked if he’d continue to fly with the airline amid its turmoil, he replied, “most likely.”

“If you’re flying the next two or three weeks, it’s still the best deal,” he said. “The price difference between Spirit and everybody else is a lot. And you get to fly nonstop, which is the other thing.

“Will I keep an eye on the news? Of course,” he added. “I’m presuming between now and January they will be fine.”

Capacity reductions

Of late, the airline has engaged in substantial scheduling adjustments, and in a regulatory filing it forecast year over-year capacity reductions of 20% in the fourth quarter and in the “mid teens” for the entirety of 2025. The reductions are partly attributable to the sale of 23 Airbus jetliners, which will be removed from its fleet.

Late last month, The Points Guy, the travel website for airline passengers, reported Spirit had cut 32 routes, many in the West. The site also noted seven routes were dropped from Logan International Airport in Boston. Only one route was cut from Fort Lauderdale — to Salt Lake City.

Clint Henderson, managing editor at The Points Guy, said he doubts any further reductions are in the offing until at least January because the airline already has instituted deep cuts.

“If I had a flight booked for the holidays I would not be worried at all,” he said.

“Hopefully passengers have already been notified and have made alternate arrangements for the holidays,” he added, speaking of flights that have been removed from the schedule.

Specific figures for the third quarter are hard to come by as Spirit has yet to report its quarterly results, saying it will do so in mid-November, well after its peers. In the second quarter, Spirit posted a net loss of $192.9 million. The airline hasn’t posted a net profit since before COVID-19.

Spirit’s shift into downsize mode came after a variety of setbacks for the airline, starting with a federal judge’s rejection of Spirit’s proposed $3.8 billion takeover by New York-based JetBlue Airways on antitrust grounds. JetBlue,
which has had its own financial losing streak, is also in the midst of a campaign to make money again.

The proposed takeover by JetBlue would have meant the end of Spirit as an independent carrier. A previously proposed merger with Frontier collapsed in the face of JetBlue’s offer.

Once the merger and takeover offers went off the table, Spirit was left to fend for itself.

One immediate major problem — beyond its control — involves a manufacturer’s recall of Pratt & Whitney engines that forced Spirit to ground aircraft to allow for an extended program of inspections. Although Spirit has worked out a compensation program that runs into the millions to account for the business losses, the aircraft groundings created a major disruption in its operations.

Heavy debts spawn bankruptcy talk

Earlier this year, Spirit CEO and President Ted Christie, who has labored long and hard to upgrade the airline’s brand and reputation — the latest being a revised menu of more fare and service options for customers — publicly bristled at analyst predictions that a bankruptcy filing might be the only way to relieve the company of its financial pressures.

The company line has been that it prefers to renegotiate its debt obligations without the help of a bankruptcy court and the controlled supervision it provides.

But industry analysts have wondered if the approach can be sustained under pressure from lenders who are owed up to $3.3 billion.

“Spirit fully unveiled its standalone plan with a (still low-cost) premium and passenger-friendly offering that should reinvigorate the brand,” Raymond James analyst Savanthi Syth said in a note to investors. “However, we see risk in the patience of Spirit’s creditors to fund an uphill marketing battle …”

Cash is king, and the airline has spent a number of months building a war chest.

“They have to figure out how to get enough cash liquidity to get to the finish line,” said Joseph Luzinski, senior managing director of DSI, a financial advisory firm in Miami and Fort Lauderdale.

By the end of the year, the company has said in a regulatory filing, it expects to have roughly $1.1 billion in liquidity, in large part on the strength of its recent sale of 23 Airbus jetliners. It also borrowed $300 million from a credit line.

“I think what they’ve done is going to get them through the first quarter of next year,” said Joseph Smith, an investment banker specializing in aviation at Cassell Salpeter & Co. in Miami. “They’ve raised enough cash selling these birds.”

The company has not commented on a more recent Wall Street Journal report that it discussed a Chapter 11 bankruptcy scenario with its bondholders, and that it renewed merger talks with rival discounter Frontier Airlines in the context of a possible asset acquisition through bankruptcy.

The Denver-based airline has declined comment.

If a bankruptcy filing does occur, Spirit would likely continue flying, but under a court’s supervision. “Even if the worst case happens, consumers are still pretty protected when a U.S. carrier declares bankruptcy because it keeps operating,” Henderson said.

It remains unclear how the airline will ultimately fix its finances as it deals with creditors behind the scenes.

“Often these things are on a parallel track,” Luzinski said. “We’re going to file for bankruptcy and blow everybody out. Or as a negotiating ploy you say, ‘if we make a deal we file and get exactly what you want out of this transaction.’”

Whither the discounters?

Whatever happens, customers such as Ivan Reich would like to see the airline preserved. Without discount carriers, he suggested, consumer choices will be narrowed to legacy carriers such as Delta Air Lines, which charge higher prices.

“I like the cheap flights,” Reich said. “If you are going to go away for a weekend and throw everything in an overnight bag, you can’t beat it.”

“Look at the Spirit prices compared to everybody else and there is a substantial difference,” he added. “Where are you going to find bargains? What happens to the marketplace where all you have is the legacy carriers?”

 

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Local Community Expert shares money-saving tips after Fed cuts interest rates


September 19, 2024
By Joe Gorchow

MIAMI – One day after the Federal Reserve lowered interest rates, CBS News Miami is exploring how the move can help you save money on loans, credit cards and mortgages.

Miami investment banker Jim Cassel explained how to cash in and save on the expenses weighing you down.

“It pays to refinance and chase it down, which is what people have done,” Cassel said.

By “it,” he means the rate that affects what is paid for loans. Cassel said he sees Wednesday’s decision as an opportunity to adjust student loans, credit card debt and mortgage rates.

“Sometimes, even doing it with the same lender, you can save points, other expenses, legal fees and things,” Cassel said. “Pick up the phone and call a lender and negotiate a lower rate.”

People were interviewed about the rate change after it was announced.

Before the move by the Fed, residents in Miami also shared their borrowing experiences.

“Buying a house is kind of impossible right now,” Brickell resident Fabianny Crespo said. She hopes to one day trade in the apartment life and walk toward Biscayne Bay for a life living in a house with a fence.

“When I came to Miami, a regular salary was enough to cover the basics,” Crespo said. “Now you have to struggle with, even with a $100,000 salary.”

Crespo and countless others like her hope a big move could come soon.

“It’s extremely hard,” said a Miami resident who goes by Cyntrina. “It’s very difficult.”

Cyntrina said she made a life-changing decision to give up her car and take the bus to save money. However, perhaps the Fed’s decision to lower interest rates might help her situation.

“Deals out there that if you want to move from one credit card to another,” Cassel said. “Many times not have to pay interest, get a hiatus period, or a lower interest rate.”

Besides dealing with debt, Cassel said homeowners should consider locking in a lower mortgage rate to save thousands.

“Personally, I did it three times many years ago,” Cassel said. “As we were chasing rates down, my rate ended up at 3%.”

Cassel said that can mean savings of thousands of dollars a year for homeowners. It can also be savings on car loans.

And with any big purchase, for a car or a home, Cassel advises to look beyond the rate and at your budget.

“I’m not prepared for that,” Crespo said about buying a home. “I’m just trying to increase my salary however I can.”

Cassel advises creating an Excel spreadsheet to see if you can afford a significant purchase like a home or car before making a quick decision. And if you’re unsure, he said to visit a bank or a qualified lender to help you understand your price range.

 

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Expect ‘B’ Assets to Come to Market First as Dealflow Waits to Pick Up

September 6, 2024
By Demitri Diakantonis

There’s the annual summer deal lull, then there’s the flat cycle as dealmakers wait for interest rates to pick up and for the results of the November elections. Still though, there’s nothing positive about the latest numbers, as August deal volume was the worst in three years, according to data supplied by LSEG. Here’s our monthly deal analysis.

There were just 44 mid-market deals in August, the lowest monthly tally year to date and worst since August 2021. Deal value came in at around $19 billion, the second lowest total this year after February’s $16.4 billion output.

Investors are saying deal activity will pick up, eventually. But when that happens, don’t expect the winners to come out of the gate right away, as sponsors are desperate to return liquidity to their LPs, while waiting to get top value for their most prized assets.

“Most of what I think will come out from a lot of sponsors in the next three to nine months are what I call the B-assets,” says Oaktree Capital Managing Director Matt Wilson. “These are not top-tier portfolio companies, but assets that need to be sold to extract whatever returns sponsors can get so they can return capital and raise the next fund. These are probably the most price sensitive assets to interest rates, hence the reason they haven’t had a bid over the last 18-24 months.

“Right now, for a lot of sponsors, it’s about ‘We haven’t sold much in the last two years and we have to return capital to retain our clients and raise the next fund. Let’s try to sell our second-tier assets, get what we can for them so we can return the capital, and keep our real gems, the assets we will make the most money on in 2025 when we have more clarity on rates,” he adds.

Looking at specific sectors, the top two industry staples-technology is down
significantly, while healthcare is still down slightly year-over-year. In other sectors, real estate, consumer products and services are down. On the other end of the spectrum, consumer staples and industrials are on the rise.
Other notable deals that closed last month include:

  • Quest Diagnostics‘ (NYSE: DGX) $987 million deal for laboratory test company LifeLabs
  • Bank of Nova Scotia’s (NYSE: BNS) minority investment in regional bank KeyCorp (NYSE: KEY)
  • Gallatin Point Capital’s minority investment in commercial bank Israel Discount Bank of New York

In the league tables, JP Morgan (NYSE: JPM), Goldman Sachs (NYSE: GS) and Morgan Stanley hold the top three spots in terms of number of deals (34, 29 and 22, respectively) and deal volume (about $16.4 billion, $16.2 billion and $10.6 billion, respectively). A couple of other banks made big jumps into the top 10. Wells Fargo (NYSE: WFC) went from 22nd to eighth place and Moelis (NYSE: MC) went from 18th to ninth place.

“I believe we will see an uptick in mid-market M&A during the last four months of the year,” says James Cassel, co-founder of Miami-based investment bank Cassel Salpeter & Co. “There is a robust pipeline of deals that were preparing to go to market as well as pent up demand on the buy side for companies and PE firms to deploy capital.”

 

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Rafael Holdings and Cyclo Therapeutics Enter Into a Definitive Merger Agreement

Cyclo Therapeutics’ TransportNPC™ Phase 3 clinical trial for Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1, a rare and fatal genetic disease, is fully enrolled and results from the 48-week interim analysis are expected in the middle of 2025

Aug. 22, 2024

NEWARK, N.J. & GAINESVILLE, Fla.–(BUSINESS WIRE)–Rafael Holdings, Inc. (NYSE: RFL), and Cyclo Therapeutics, Inc. (Nasdaq: CYTH) today announced that they have entered into a definitive merger agreement to combine the two companies to focus on the development of Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1. On consummation of the merger, Rafael Holdings will issue shares of its Class B common stock to Cyclo Therapeutics’ shareholders, based on an exchange ratio valuing Cyclo Therapeutics shares at $.95 per share and Rafael Holdings at its cash value combined with the value of its marketable securities and certain other investments less certain current liabilities. In addition, the cash value will take into account the funding of Cyclo’s operations by Rafael with convertible notes through closing. Following the closing, Rafael Holdings intends to fund the TransportNPC™ clinical trial to its 48-week interim analysis. The boards of directors of Rafael Holdings and Cyclo Therapeutics have approved this transaction and expect it to close in late 2024, pending approval of the companies’ shareholders, the effectiveness of a registration statement to register the shares of Class B common stock of Rafael Holdings to be issued in the transaction and other customary closing conditions.

Rafael Holdings made its first strategic investment in Cyclo Therapeutics in March 2023 to help drive treatment innovation for patients with the debilitating diagnosis of Niemann-Pick Disease Type C1. Rafael Holdings led another financing round in the fall of 2023 and has continued to support Cyclo Therapeutics via convertible debt financings in 2024.

“The proposed merger with Cyclo Therapeutics is a major step forward in our strategy to invest in, develop and commercialize clinical stage assets in areas of high unmet medical need,” said Bill Conkling, President and CEO of Rafael Holdings. Bill added, “Cyclo Therapeutics continues to make substantial progress in advancing its lead asset, Trappsol® Cyclo™, announcing the completion of enrollment in its pivotal TransportNPC™ Phase 3 clinical study for the treatment of Niemann-Pick Disease Type C1 at the end of May 2024. We are impressed with the execution by the Cyclo Therapeutics team in fully enrolling a comprehensive clinical trial in NPC and we eagerly await the 48-week interim analysis in the middle of 2025. Rafael Holdings is excited to join forces with Cyclo Therapeutics to make Trappsol® Cyclo™ our lead clinical program. We are committed to the program and will leverage our resources to help bring this much needed treatment option to NPC patients.”

N. Scott Fine, Chief Executive Officer of Cyclo Therapeutics, commented, “Our partnership with Rafael Holdings during the last year and a half has enabled Cyclo to get to where we are today. We are extremely pleased to announce our merger agreement with Rafael Holdings and believe that the strength of Rafael’s balance sheet and its strong management team will solidify our commitment to deliver the results of the TransportNPC™ trial for our shareholders and patients.”

Cassel Salpeter & Co. is acting as financial advisor to Cyclo Therapeutics in connection with the transaction. Schwell Wimpfheimer & Associates is serving as legal advisor to Rafael Holdings and Fox Rothschild LLP is serving as legal advisor to Cyclo Therapeutics.

 

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North American consumer trendspotter: Deal volume jumps up after 2023 lows; uptick in buyout value

16th July 2024
By Katishi Maake, Brian Yue, Marlene Star and Manu Rajput

Consumer merger and acquisition volume saw a 46% year-over-year increase in 1H24 to USD 31.95bn, and buyout volumes crept up from 1H23, according to Mergermarket data. As concerns over a recession have waned over the past year, dealmakers have become slightly optimistic but cautiously so.

The top global deal is Macy’s [NYSE:M] pending 91.24% stake sale to Arkhouse Partners and Brigade Capital Management for USD 6.249bn, based on a cash offer price of USD 24 per share, which values Macy’s at USD 12.076bn, including net debt. Arkhouse Partners and Brigade Capital Management reportedly increased their offer to acquire the department store chain earlier this month to USD 24.80 per share, roughly USD 6.9bn, according to the Wall Street Journal.

Other major North American transactions include the USD 4.6bn merger of Primo Water Corporation [NYSE:PRMW, TSX:PRMW] and BlueTrion Brands, and Walmart’s [NYSE:WMT] USD 2.3bn acquisition of television maker Vizio.

The first half of the year saw buyout volumes of USD 1.6bn, compared to USD 1.05bn in 1H23. In May, Brightstar Capital Partners agreed to acquire Nevada-based slot machine maker PlayAGS in a USD 1.1 bn deal that’s expected to close in the latter half of 2025. Deal valuations totaled USD 1.48 bn across 19 deals during 1H24, according to Mergermarket data. Sector advisers hope the increased activity will continue in 2H24, but that will be highly dependent on inflation and how the Federal Reserve acts on interest rates.

Beauty and pet products a bright spot
The consumer sector’s perennial strong areas – pet, beauty and consumer services – continued to perform well in 1H24. Pet and beauty continue to be active as investors see continued growth in the space, according to Richard Kestenbaum, co-founder and partner at Triangle Capital.

“We wind up selling companies that identified a way to make great money and be successful in industries that were often tired,” Kestenbaum says. “It’s both industries that are growing and consolidating but it’s also innovation in existing spaces.”

Conversely, sub-sectors such as durables, apparel, hard goods, furniture, and discretionary items are not performing as well due to tighter consumer budgets, Christopher Petrossian, managing director at Lincoln International says.

Restaurants are likely to see restructuring-driven deals in 2H24 as food and labor costs continue to climb, particularly in California where the minimum wage for restaurants rose to USD 20 per hour in April, says Jim Cassel, chairman and co-founder of Cassel Salpeter & Co. These pricing pressures under already small margins have restaurants looking to sell, Cassel says, adding that potential changes in tax laws around capital gains might also lead to the sale of troubled assets.

In CPG, there’s been a lot of activity redeploying cash and selling assets with the intent of assessing where the market will be over the next decade, Andrew Dickow, managing director at Greenwich Capital Group, says. Unilever’s [LON:ULVR] sale of Ben & Jerry’s is exemplary of this, as the company attempts to transition from food and beverage to consumer products.

Food and beverage – a lack of appetite
The food and beverage sector contributed about USD 9.5bn of deal value on 118 deals announced in 1H24, according to Mergermarket data. The largest deal was a still-pending USD 4.6m merger between Primo Water Corporation [NYSE:PRMW, TSX:PRMW] and BlueTrion Brands.

The sector has continued to see significant declines in deal volume compared to pre-pandemic levels.

The macro outlook for food and beverage M&A has been weak since 2021, with deal volume continuing to drop due to a decline in VC funding and the creation of new startups, according to Michael Zakkour, managing director at SellSide Group.

“There were probably too many [startups] at one point, and this is just a natural correction where deal flow is lower because there just simply aren’t as many potential new targets coming online,” Zakkour says.

Consumer preferences are shifting towards discretionary spending on experiences over products, which Zakkour notes could lead to a resurgence in deal flow for health and wellness products and quick service restaurants offering unique experiences.

The continued low number of PE and VC exits in food and beverage compared to pre-pandemic levels is due to increasing consumer acquisition costs and how crowded the sector is, Zakkour says. However, that could change in the next 1 or 2 years as investors better understand how data in e-commerce affects the products brought to market and put on shelves, he adds.

A wait-and-see game with the economy
Consumer M&A activity in 2HQ2 will be largely defined by the larger macroeconomic trends affecting consumer spending and borrowing for transactions.

While there is plenty of available debt for deal, particularly on the private debt side, high interest rates have made it difficult for buyers to borrow funds, Petrossian says. Once the Federal Reserve begins to cut rates, more capital will be available, leading to more M&A activity, he says.

Inflation is also a mitigating factor for deals getting done, Petrossian says. One private equity firm told him that 70% of its 2023 deals that came to market failed due to concerns surrounding inflation and consumer spending and sentiment.

Lincoln International’s approach has been to sit and wait on its backlog of consumer deals until market conditions improve, he says. The firm will reassess its pipeline after Labor Day in case it wants to close deals before the end of the year. Alternatively, it may wait until 1Q25 after the Federal Reserve cuts interest rates and the presidential election is decided, Petrossian says. “Forecasting this year’s fourth quarter and being in the middle of a deal and missing your budget is not a good thing to process,” Petrossian says. “At a certain point, it might make sense to
close Q4, see what it looks like, and go in on a deal early next year.”

A recession, in theory, would be devastating to consumer M&A activity, but Triangle Capital’s Kestenbaum says that’s much less of a concern now compared to inflationary pressures. “The market hates surprises and it wants to see good news, and it wants to be told good news is coming,” he adds.

By Katishi Maake, Brian Yue and Marlene Star, with analytics by Manu Rajput

 

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What’s Driving M&A Deal Activity?

ABOUT THIS SERIES

TradeTalks on Market Strategy &Portfolio Management

WITH JILL MALANDRINO

TradeTalks broadcasts live from MarketSite in Times Square, the historic Philadelphia Trading Floor and Global Industry Conferences and Events. Featuring conversations with top industry thought leaders on trends, news and education.

April 30, 2024

Michael Smith, Managing Director at STS Capital Partners, Nicholas Rodriguez, Partner at Winston & Strawn, and Jim Cassel, Co-Founder & Chairman of Cassel Salpeter & Co., join Jill Malandrino on Nasdaq TradeTalks to discuss what’s driving M&A deal activity, despite a challenging economic environment and high interest rates?

 

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5 Cell and Gene Therapy Decisions to Watch in 2024

By Ana Mulero
April 22, 2024

In 2023, cell and gene therapy saw an unprecedented surge with seven FDA approvals, and this year, an even greater number of these treatments could reach the market. So far in 2024, the regulator has given the green light to three new CGTs, and at least seven additional cell and gene therapy products are expected to receive approval by year’s end, according to a March report from the Alliance for Regenerative Medicine.

“All signs point to 2024 surpassing 2023 as a landmark year for cell and gene therapy,” David Barrett, CEO of the American Society of Gene & Cell Therapy (ASGCT), told BioSpace.

The first approval this year belonged to Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy, which won the FDA’s nod in January for use in transfusion-dependent beta thalassemia. This followed the agency’s December 2023 approval of Casgevy as one of the first two cell-based gene therapies to treat patients with sickle cell disease. It also represented the first FDA approval of a therapy using CRISPR/Cas9 technology. Then, in February, Iovance Biotherapeutics’ Amtagvi was approved as the first one-time cell therapy for a solid tumor and the first tumor-infiltrating lymphocytes therapy, for advanced melanoma patients who have worsened after being treated with certain other therapies failed. Finally, last month, the FDA greenlit Orchard Therapeutics’ Lenmeldy, which entered the U.S. market as the first gene therapy for children with metachromatic leukodystrophy, and the world’s most expensive drug, with a $4.25 million price tag. 

Looking forward, the FDA has upcoming PDUFA dates for several more novel CGTs, including a traditional in vivo gene therapy delivered via viral vector, a couple of gene-corrected cell therapies in which a patient’s cells are modified by gene therapy outside of the body and then reinfused, and a new CAR-T.

Two Q1 reports, from ASGCT and the Alliance for Regenerative Medicine, highlight some of these regulatory actions as potential catalysts for the sector, with approvals poised to propel the CGT space. The ASGCT report includes a list of noteworthy events in Q1 2024, while ARM’s report makes the case that 2024 could be a banner year for cell therapy.

Here, BioSpace reviews five products under regulatory review that were highlighted by both organizations.

Pfizer’s Beqvez

Indication: Hemophilia B

Therapy type: In vivo gene therapy

Action date: April 27

Later this month, the FDA will rule on Pfizer’s gene therapy for hemophilia B, Beqvez. This engineered version of the factor IX coagulation gene carried by an adeno-associated virus is administered via a single infusion.

Beqvez has been approved by Health Canada to treat adults with hemophilia B based on positive data from the Phase III BENEGENE-2 study, which showed a significant reduction in bleeding rate and infusion frequency.

The Big Picture

An FDA approval would put Pfizer in competition with CSL Behring, whose gene therapy Hemgenix, which is also administered via a single intravenous infusion, became the first FDA-approved gene therapy for hemophilia B in November 2022. Pricing details for Beqvez are not yet available, but Hemgenix costs $3.5 million per dose. Chris Boshoff, Pfizer’s chief oncology officer, told BioSpace the company aims to leverage its experience to ensure smooth market entry and efficient delivery to eligible patients.

Abeona Therapeutics’ pz-cel

Indication: Recessive dystrophic epidermolysis bullosa

Therapy type: Gene-corrected cell therapy

Action date: May 25

Next up is Abeona Therapeutics’ pz-cel, which delivers a functional collagen-producing COL7A1 gene into a patient’s own skin cells using a retroviral vector, for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB). RDEB, a rare connective tissue disorder, causes severe skin wounds, pain and life-threatening complications stemming from compromised immunity due to a deficiency in the COL7A1 gene, preventing the production of functional type VII collagen.

In November 2023, the FDA granted priority review to pz-cel based on clinical data from the Phase III VIITAL study and long-term results from a Phase I/IIa study, which demonstrated sustained wound healing and pain reduction.

The Big Picture

Ira Leiderman, managing director of healthcare at Cassel Salpeter, underscored the importance of evaluating therapeutic options against the rarity and impact of the disease. A positive decision on Abeona’s pz-cel will help address the high unmet need of RDEB patients and may lead to transformative interventions in this challenging rare genetic disorder, Leiderman told BioSpace.

If approved, pz-cel would follow Krystal Biotech’s Vyjuvek, the first gene therapy approved for recessive or dominant DEB in May 2023. Abeona said in March it is actively preparing for the potential U.S. launch of pz-cel, including discussions with treatment sites and payer engagement.

Rocket Pharmaceuticals’ Kresladi

Indication: Leukocyte adhesion deficiency-1

Therapy type: Ex-vivo vector gene therapy

Action date: June 30

While Rocket Pharmaceuticals initially anticipated a decision on its gene therapy for leukocyte adhesion deficiency-I (LAD-I) by March, the FDA requested more review time and extended the deadline to June 30.

Severe LAD-I, a rare genetic disorder affecting children, is caused by mutations in the ITGB2 gene that lead to life-threatening infections. Without regular bone marrow transplants, survival beyond childhood is rare. Kresladi contains patient-derived hematopoietic stem cells genetically modified with a lentiviral vector to carry functional copies of the ITGB2 gene, crucial for leukocyte adhesion and infection-fighting.

In November 2023, the FDA accepted Rocket’s BLA for Kresladi with priority review, following positive efficacy and safety data from a global Phase I/II study, in which all nine LAD-I patients were alive 12 to 24 months post-infusion. Significant reductions in infection rates were observed compared to pre-treatment levels, along with the resolution of LAD-I–related skin lesions and restoration of wound healing capabilities.

Kresladi also holds the FDA’s Regenerative Medicine Advanced Therapy, Rare Pediatric, Fast Track and Orphan Drug designations.

The Big Picture

This marks Rocket’s inaugural product filing and is a notable advancement for patients, offering an alternative to bone marrow transplant, which carries significant risks and may not be readily accessible. Rocket is enhancing its commercial infrastructure in preparation for a potential product launch, including center initiation, channel strategies, education and payer engagement.

Rocket CEO Gaurav Shah told BioSpace the FDA is reallocating reviewers to focus on rare diseases and complex biologics, necessitating changes and a transition period. Shah noted that the delayed decision, based on the FDA’s request for clarity on chemistry, manufacturing and controls information submitted by Rocket, is common among CGTs and does not raise significant concerns beyond ensuring the regulator has sufficient resources for the approval process.

Adaptimmune’s afami-cel

Indication: Advanced synovial sarcoma

Therapy type: T cell receptor therapy

Action date: August 4

 

Adaptimmune is gearing up for the potential launch of its inaugural product in the sarcoma franchise, afami-cel, intended for treating advanced synovial sarcoma, with a PDUFA date set for August 4. Afami-cel received FDA priority review in January.

Synovial sarcoma, which makes up 5% to 10% of soft tissue sarcomas, typically affects individuals under 30, with a five-year survival rate of 20% for metastatic cases. Recurrence is frequent, necessitating multiple lines of therapy and potential exhaustion of treatment options. Afami-cel is a single-dose engineered T cell receptor therapy targeting MAGE-A4-posititive tumor cells. The therapy’s clinical data from the SPEARHEAD-1 trial revealed that about 39% of patients experienced clinical responses, with a median response duration of around 12 months. Median overall survival was about 17 months, contrasting with historical data of less than 12 months for those who received two or more prior lines of therapy. Some 70% of responders to afami-cel were alive two years post-treatment.

The FDA granted afami-cel Orphan Drug Designation for the treatment of soft tissue sarcomas and Regenerative Medicine Advanced Therapy designation.

The Big Picture

If approved, afami-cel would become the first approved engineered T cell therapy for this type of cancer. In November 2023, the Investigational New Drug (IND) for another T cell therapy, lete-cel, was transferred from GSK to Adaptimmune for the pivotal IGNYTE-ESO clinical trial, following an interim analysis showing a 40% response rate in synovial sarcoma or myxoid/round cell liposarcoma patients.

Adaptimmune CEO Adrian Rawcliffe said that the clinical results from the pivotal trial position lete-cel as a complement to afami-cel, potentially allowing the company’s sarcoma franchise to significantly expand its reach. He noted that leveraging the same commercial infrastructure intended for afami-cel could facilitate the efficient delivery of lete-cel to the market. Afami-cel would become the first engineered T cell therapy for a solid tumor. The franchise, including both afami-cel and lete-cel, “is projected to deliver up to $400 million in U.S. peak year sales,” Rawcliffe said in March.

Autolus Therapeutics’ obe-cel

Indication: B cell acute lymphoblastic leukemia

Therapy type: CAR-T cell therapy

Action date: November 16

In accepting Autolus Therapeutics’ BLA for its lead next-generation CAR-T therapy obe-cel for relapsed/refractory adult acute lymphoblastic leukemia (ALL) in January, the FDA set a PDUFA target action date of November 16.

Obe-cel, an investigational CD19 CAR-T cell therapy, is designed to enhance clinical activity and safety compared to existing therapies by incorporating a fast target binding off-rate, minimizing T cell activation. In December 2022, Autolus hailed the Phase II FELIX trial as a success, as interim analysis showcased an overall remission rate of 70% for obe-cel in leukemia patients. CAR-T cell concentration peaked and persisted at 75% in peripheral blood after a median of 166.5 days post-infusion. The trial also demonstrated positive safety findings. 

Obe-cel holds the FDA’s Orphan Drug and Regenerative Medicine Advanced Therapy status. Earlier this month, the company;’s obe-cel marketing application was accepted by the European Medicines Agency.

The Big Picture

The potential approval of a second cell therapy for solid tumors this year suggests breakthroughs in treating these cancers may be near, Stephen Majors, a spokesperson for the ARM, told BioSpace. There is an “increasing focus on solid tumors,” a previously elusive area for cell and gene therapy, he said.

A recent $250 million deal granted BioNTech access to obe-cel, with the partner to aid in the launch and development program expansion and receive royalties based on net sales. Autolus expects obe-cel peak sales to exceed $300 million.

Autolus could face competition from Gilead Sciences subsidiary Kite, which in 2021 gained FDA approval for its CAR-T therapy Tecartus, the first such treatment for ALL, achieving a 65% complete remission rate.

Ana Mulero is a freelance writer based in Puerto Rico. She can be reached at anacmulero@outlook.com and @anitamulero on X.

 

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Distressed Scooter Giant Bird Global Sold to Third Lane Mobility for $145 Million

By Bob Clair

Bird Global Inc., one of the largest scooter rental businesses in North America, was sold to its debtholders in a bankruptcy-led process.

Bird, which went public via SPAC in 2019, had failed to reach profitability and burned more than $650 million of cash from 2020 through 2022. In total, the company dispatched more than $1.1 billion in venture funding.

“They were very successful in raising capital for a substantial period of time, but the markets have not been as forgiving for growth companies as they were a few years ago,” said James Cassel, chairman and co-founder of Miami-based investment bank Cassel Salpeter & Co., Bird’s financial advisor.

After reaching a peak valuation of $2.5 billion in its Series D, the business was delisted in September 2023 and entered into Chapter 11 bankruptcy in December—prompted by debtors’ desire for a Section 363 sale.

First lien holders were led by MidCap Financial, an affiliate of Apollo Global Management, while second lien holders were led by Obelysk Inc. The group provided up to $33 million in new money first lien DIP financing at a 15% interest rate (6% cash, 9% payment-in-kind), along with $6 million in new money second lien notes at an 18% PIK interest rate.

Speaking to Transacted, Cassel described a broad sale process with a mix of sponsor and strategic interest.

“We went to 137 potential purchasers, 81 that we identified as strategic parties,” Cassel said. “We talked to anybody and everybody. People like Lime and Uber and Citi Bike, as well as private equity firms that buy distressed businesses. We went to all the players, both domestic and foreign.”

Christopher Rankin, Bird’s Chief Restructuring Officer, confirmed there was interest from strategics, though declined to share how far competitors progressed in the bidding process.

When asked, Lime, the Uber-backed industry leader, said via spokesman Russell Murphy only that “we are not going to comment on Bird’s situation.”

In the absence of a competitive offer, Bird was purchased by stalking horse bidder Third Lane Mobility, an entity formed by a consortium of the company’s first and second lien holders.

“The stalking horse bidders were a related party, so that adds a fair amount of complexity to make sure the proper process was run and that we went to the proper parties. We got the cooperation of management, which, on the one hand, may be conflicted because they are part of the buyer, but on the other hand, they are part of the seller,” Cassel said.

MidCap Financial did not respond to requests for comment.

Bird’s outcome is the latest setback for the challenged scooter and bike rental industry. Once a hotbed of venture activity, unprofitable operators have shut down or consolidated in recent years – Bird itself had bought rival Spin and platform partner Bird Canada as recently as late 2023.

Cassel said he expects further consolidation, particularly among the large number of smaller regional players.

Along with scale, Cassel notes that micromobility M&A “can be a way to get into certain markets or a way to obtain certain contracts.”

As for Bird, Rankin said he doesn’t expect new owner Third Lane to be acquisitive anytime soon.

“I don’t think they’ll be making acquisitions. It’s up to them, but I don’t expect that,” Rankin said.

Bob Clair

Bob Clair is a reporter at Transacted covering private equity and investment banking. He has covered breaking M&A news for several years and is a general assignment freelance reporter for The New York Times, where he shared in a 2021 Pulitzer Prize win.

 

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Flying cars are coming! Here’s how they could change the way you travel.

Christopher Elliott

Special to USA TODAY

April 9, 2024

If you’d told me a few weeks ago that flying cars will change the way we travel, I probably would have laughed at you. 

But when Elon Musk hinted there might be a flying Tesla soon, the internet started buzzing with flying-car news. And now people are talking.

“There’s absolutely a sense that the time has come,” said aviation industry investment banker Joey Smith at Cassel Salpeter & Co. “Numerous well-funded companies are racing to build a viable production vehicle, and they could take to the skies as early as next year.”

Check out Elliott Confidential, the newsletter the travel industry doesn’t want you to read. Each issue is filled with breaking news, deep insights, and exclusive strategies for becoming a better traveler. But don’t tell anyone!

What’s more, attitudes toward Advanced Air Mobility (AAM) – that’s a fancy term for flying cars and other personal flying vehicles – have shifted. A new study suggests Americans, and particularly younger urban consumers, are warming to the idea of flying to their next destination. Even so, the definition of a flying car is a little hard to pin down. I’ll explain in a minute.

Don’t expect to open your apartment window and see a scene out of a sci-fi movie like “Minority Report” anytime soon. (You know, lanes of flying vehicles lining the sky.) It’ll be a slow rollout, but it has the potential to change the way we travel like we haven’t seen since the introduction of the jet engine.

What kind of flying vehicles are out there?

Personal flying vehicles defy simple classification, which may be part of their allure. There are STOLs and VTOLs, quadcopters, octocopters and hexacopters. Some are electric, some are gas-powered. 

Don’t be confused by all the acronyms. I think it’s OK to just call them flying cars.

Right now, the ones generating the most noise are electric vertical takeoff and landing vehicles (eVTOLs). These aircraft take off and land like a helicopter. For example, Joby’s air taxi service in Manhattan plans to use its eVTOL, which looks like an oversized drone, to shuttle passengers from New York to John F. Kennedy International Airport next year.

My categorization is a little unconventional, but here’s how I see it: There are really just two types of flying cars. The first are cars that can drive on the road and fly, just like the ones in “Back to the Future.” 

One of the most high-profile of these is the Model A being developed by Alef Aeronautics. It’s an eVTOL that looks like a sports car. But once it takes off, the passenger cabin pivots and the vehicle flies sideways, which looks a little jarring but very cool.

The second type of flying vehicle doesn’t even bother with the road. For example, the Lilium Jet is a fixed-wing aircraft and an eVTOL. But you won’t see it on the highway unless it’s making an emergency landing – so technically, it’s not a flying car.

Like I said, these flying vehicles aren’t easy to categorize. And it hasn’t really mattered until now because you could find them only in aviation magazines and science fiction movies. But now there are serious discussions about flying cars, and developers have started taking orders. The future is almost here.

Flying cars aren’t cleared for takeoff – yet

Don’t get too excited. A few things still have to be worked out, experts say. For example, eVTOL manufacturers have struggled with several challenges. It’s not just how to design lightweight aircraft made from the right composite materials and with adequate battery life. It’s also piloting the flying car. Issues such as autonomous flight capability and pilot training have proven to be big barriers. 

There are also regulatory roadblocks. The Federal Aviation Administration, which has oversight of these new vehicles, has adopted a “crawl-walk-run” approach. And it’s still in “crawl” mode. Last year, it laid down some rules for flying cars. Among them: They have to use existing heliports and they must have a human pilot. But there are no special traffic lanes in the sky for these vehicles yet.

The U.K. is also preparing for flying cars. In March, the government said it envisioned eVTOLs taking to the skies within four years

Observers are skeptical of the proposed timeline. Charles Leocha, president of the consumer group Travelers United, has worked on regulations for low-level unmanned aerial vehicles for the last decade. He said the wheels are turning slowly.

“The FAA is at least a decade away from allowing or approving any kind of flying car,” he said.

All of that has made people reluctant to order a flying car – if they can afford one. Most vehicles can cost $150,000 to as much as $10 million.

“Prospective buyers are likely to hold off until regulatory barriers are dismantled,” said Francesco Cerroni, a mobility expert at the design firm Buro Happold.

Where to find personal flying vehicles now

If you want to see a flying vehicle for yourself, here’s where to find them (outside of the movie theater):

  • Lift Aircraft, which manufactures a single-seat eVTOL called Hexa, is offering test flights on its single-seat Hexas this spring. It’s scheduled to be in Lakeland Linder International Airport in Florida in April and Austin in May.
  • Early next year, you’ll be able to hail an air taxi from Abu Dhabi and Dubai on a four-passenger Midnight aircraft. The eVTOL, operated by UAE-based Falcon Aviation, will cover the 81-mile trip in just 30 minutes. By road, the drive can take a few hours in traffic.
  • There’s even a flying car driving school. Netherlands auto manufacturer PAL-V will show you the ins and outs of flying a car. They even have a flying car showroom in Munich where you can buy your own gyroplane/car combination. (It’ll cost you about $550,000.)

Bottom line: Flying cars remain rare. But change is on the horizon.

How flying cars could change the way we travel

High prices and continued doubts about the viability of zipping around town like George Jetson haven’t stopped people from thinking about the future. Experts seem to agree that safe VTOLs with FAA approval could change travel forever.

“It would reduce congestion by removing some traffic on the road and create a new aviation sector, with new jobs,” said Raj Rajkumar, professor of computer engineering at Carnegie Mellon University.

Flying cars could dramatically cut the drive time between destinations typically served by short-haul commercial flights. So instead of catching a shuttle flight from Washington to New York, you’d just fly there in your own car in a fraction of the time it used to take to drive.

But that’s just the beginning. As these vehicles become faster and more affordable, they hold the promise of competing with commercial aviation. Imagine flying your family car from the suburbs of an East Coast city to Florida for your next vacation in less time than it would take you to go to the airport, get through security, wait for your departure, fly, land, collect your luggage and rent an earthbound car?

The thought of ditching airlines, with their awful customer service and addictive loyalty programs, may be the greatest promise of the AAV revolution.

If you’d asked me a few weeks ago if such a future was possible, I would have been very skeptical. Now, I’m just a little skeptical.

This is the second of a two-part series on the future of air travel.

Christopher Elliott is an author, consumer advocate, and journalist. He founded Elliott Advocacy, a nonprofit organization that helps solve consumer problems. He publishes Elliott Confidential, a travel newsletter, and the Elliott Report, a news site about customer service. If you need help with a consumer problem, you can reach him here or email him at chris@elliott.org.

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QEP Completes Sale Of Australia/New Zealand Business

March 04, 2024 08:28 ET | Source: Q.E.P. Co., Inc.

BOCA RATON, Fla., March. 04, 2024 (GLOBE NEWSWIRE) — Q.E.P. CO., INC. (OTCQX: QEPC) (the “Company” or “QEP”) today announced that it has completed the previously announced sale of its Australia and New Zealand business (the “ANZ Business”) to QEP Australasia Pty. Ltd. led by Bruce Maclaren and Tony Lei, in a transaction valued at AUD 14.05 million.

Bruce Maclaren has served as the Managing Director of the ANZ Business for 20 years including a period of three years as CEO European Operations for QEP based in the UK. Tony Lei has also been involved with QEP for over 20 years as a valued supplier to the ANZ Business and QEP’s other businesses around the world.

Executive Chairman of QEP, Lewis Gould, stated, “The closing of this transaction is another significant step to realign our global footprint to drive long-term stockholder value. The proceeds from this and other recent divestitures have been used to substantially eliminate the Company’s debt and provides us with a healthy cash position as we begin the new fiscal year. We are grateful to Bruce and Tony for their many contributions to QEP and look forward to contributing to their growth in the future.”

QEP’s President & Chief Executive Officer, Leonard Gould, commented, “This latest move further underscores our commitment to enhancing focus on our local customers. Simplifying the business removes friction allowing for increased ‘speed to market’ via new product innovations, all while maintaining our best-in-class service levels.”

In connection with this transaction, the Company has entered into Amendment No. 6 (the “Amendment”) to the Fifth Amended and Restated Loan and Security Agreement, Waiver, Consent and Release dated February 15, 2021 with its lending institution, Bank of America, N.A. The Amendment waives certain covenants and restrictions relating to this sale of assets, agrees to release all liens covering the purchased assets, and consents to this transaction. The Amendment also provides the Company with additional flexibility with respect to certain financial covenants as well as permitted acquisitions and distributions.

As part of its consideration in approving the transaction, QEP’s Board of Directors appointed a Special Committee of independent and disinterested directors, to consider and recommend the transaction for approval by the Board of Directors. In recommending the transaction to the Board of Directors for approval, the Special Committee considered the financial advice from its financial advisor, Cassel Salpeter & Co. LLC, a third party investment banking firm.

About QEP

Founded in 1979, Q.E.P. Co., Inc. is a leading designer, manufacturer and distributor of a broad range of best-in-class flooring installation solutions for commercial and home improvement projects worldwide. QEP offers a comprehensive line of specialty installation tools, adhesives, and underlayment. QEP sells its products throughout the world to home improvement retail centers, and professional specialty distribution outlets, under brand names including QEP®, LASH®, ROBERTS®, Capitol®, Premix- Marbletite® (PMM), Brutus®, Homelux®, PRCI®, and Tomecanic®.

QEP is headquartered in Boca Raton, Florida with offices in Canada, Europe, Asia, Australia and New Zealand. Please visit our website
at www.qepcorporate.com.

Forward-Looking Statements

All statements contained in this press release, other than statements of historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning. Forward-looking statements include, but are not limited to, statements regarding the Company’s business following the sale. Any forward-looking statements contained herein are based on current expectations and beliefs, and are subject to a number of risks and uncertainties, including those listed in the Company’s annual report, as such risk factors may be amended, supplemented or superseded from time to time by other reports and disclosures made by the Company. Forward- looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements, except as required by law.

CONTACT:
Q.E.P. Co., Inc.
Enos Brown
Executive Vice President and
Chief Financial Officer
561-994-5550

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