2025 M&A Outlook: Fundraising, Lending and Distressed Deals

By Demitri Diakantonis
January 2, 2025

The M&A landscape continues to evolve, shaped by shifting economic conditions, a new political regime and dynamic corporate strategies. As we move into the new year, Mergers & Acquisitions presents a week-long special series: The 2025 M&A Outlook. In it, we gather insights from dealmakers across all corners of the M&A world to explore key trends, emerging opportunities and potential challenges that will define the dealmaking environment in the coming year.

Today we hear from our experts on several topics of interest to Private Equity including projections on fundraising, lending and the distressed markets.

What is your outlook for fundraising in 2025?

James Cassel, Co-Founder, Cassel Salpeter: There is a lot of optimism now that the coming year will be good. But there is still a lot of money to deploy and LPs still have not been returned the distributions they expected. Brand name funds never seem to have any kind of challenges in raising the next fund. Smaller funds that haven’t had liquidity yet will have some challenges. People are very optimistic that deals will get done and that will free up cash for investors. If cash gets freed up, funds will get raised.

David Duke, Partner, Kian Capital Partners: The market may remain tough as LPs have experienced limited distributions from older GP investments (e.g., DPI for 2018 vintage is well below .75x) which has constrained allocations to new funds. We are hearing that the lower end of the middle market has remained attractive to LPs given the historical alpha returns from that asset class.

Vivek Subramanyam, CEO of Technology Holdings: Private equity funds are quite optimistic about the prospects for 2025. There’s robust demand for businesses looking to strengthen market positions with easing capital costs. Strategic drivers are in place and also the promise of a more accommodating regulatory environment after the elections. They’re sitting on record levels of undeployed capital from recent fundraises while grappling with underperforming portfolios, given the last couple of years haven’t been easy for companies globally, right? And they’ve been waiting for favorable exit valuations. So, all of these are factors that we believe will lead to increased deal activity and also a much better environment for fundraising. The mood has turned dramatically from a year back.

Scott Voss, Managing Director, HarbourVest: Despite the public markets delivering record returns since their late 2022 trough, private market KPIs including exits, investment activity, and fundraising have continued to decline through 2024. We believe 2025 will be a reversal across all measures. More certainty regarding the path ahead for interest rates, inflation, and politics will drive exit activity and new deal volume. We expect fundraising, which has historically lagged a broader market rebound, will increase and accelerate into the second half of 2025 as GPs burn through the dry powder they accumulated in 2021 and 2022.

What is your outlook on the lending market?

James Bardenwerper, Director, Configure Partners: Credit funds have ample dry powder and are eager to lend for all transaction types: acquisition, refinancing and dividend recapitalizations. Furthermore, banks are wading back into the cash flow market and pursuing new opportunities. Current supply / demand imbalance (limited deals with ample capital) is driving high competition.

Wayne Kawarabayashi, Head of M&A, Union Square Advisors: Declining interest rates will be a tailwind for financing as access to capital will be more prevalent and cheaper for corporates and private equity firms for buyside M&A deals and for companies looking to raise capital for internal growth, acquisitions, or refinance maturing or expensive debt.

What’s your outlook on the distressed market in 2025?

James Bardenwerper, Director, Configure Partners: Increase as lenders finally exit dated investments, but partially offset by more favorable interest rate environment easing cash burdens, which allows more “kicking the can.” As lenders have an opportunity to deploy more capital, they can strategically exit positions that are stressed / distressed or owned. Without new deals to partially mask underperforming positions, LPs and managers place a greater emphasis on issues in the portfolio.

Andrea Guerzoni, Global Vice Chair of Strategy & Transactions, EY: The combination of lower growth, subdued demand, elevated capital and input costs, a shifting competitive landscape and rapid technology-driven innovation is creating a challenging environment. Major companies are already making significant changes to address these issues, and smaller companies, being more vulnerable, will likely drive an increase in distressed sales.

 

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After bankruptcy court, Spirit sees future as a higher value airline ‘for years to come’

 

By DAVID LYONS | South Florida Sun Sentinel

November 26, 2024

When Spirit Airlines filed its Chapter 11 bankruptcy petition in New York last week, one of its top executives offered the court a note of optimism.

The troubled South Florida-based airline, said Fred Cromer, an executive vice president and chief financial officer in a court declaration, was entering its financial overhaul process “with an eye towards continuing to deliver low-cost, high-quality service to its loyal customers, and to do so for years to come.”

The question is, does the pioneering discounter have enough time to transform its service profile from a maverick bare-bones carrier to a more upscale airline?

On approach to one of the busiest Thanksgiving travel seasons in memory, Spirit flew as usual last week after filing a “prearranged” Chapter 11 bankruptcy petition designed to quickly reduce a large chunk of debt in a restructuring deal with lenders that calls for the creditors to take $350 million in newly created equity in the airline. They’re also lending Spirit a fresh $300 million to finance operations during the Chapter 11 process.

The lender deal became bad news for existing shareholders, whose stock will be canceled when the airline expects to exit bankruptcy at some point in March. Between now and then, U.S. Bankruptcy Judge Sean H. Lane and a lender-
dominated creditors committee will be co-piloting the airline.

Here is where Spirit stood less than a week after it filed its Chapter 11 petition on Nov. 18:

  • Operating Cash: The judge signed an array of orders that allows Spirit to pay routine operating expenses ranging from employee salaries and fuel bills to a small army of vendors and airport landlords.
  • The Stock: As promised by management, Spirit’s battered common stock was delisted from the New York Stock Exchange, with trading moved to the over-the-counter market. Now the shares are acting as a penny stock (symbol SAVEQ), changing hands at 15 cents a share Friday. Before the delisting, the 52-week high for the stock (symbol SAVE) exceeded $17 with the low at $1.08.
  • Retention Bonuses: Six days before the Chapter 11, the Spirit board authorized $5.4 million in retention bonuses to five upper echelon executives led by CEO and president Ted Christie, who would receive $3.8 million, according to a regulatory filing. Companies typically use such bonuses to keep critical leadership in place during stressful times, according to compensation specialists. Christie, who joined the company in 2012 as chief finance officer, has piloted Spirit through a number of challenges: Spirit’s rough-hewn customer relations, COVID-19, two ill- fated merger/takeover attempts by Frontier Airlines and JetBlue Airways, a manufacturer’s engine recall that is grounding multiple aircraft, debt restructuring talks, and the Chapter 11 bankruptcy filing.
  • Airbus Sales: The bankruptcy court apparently is taking a look at a proposed pre-bankruptcy deal where Spirit agreed to sell 23 Airbus jetliners to the Fort Lauderdale-based aviation firm GA Telesis. A hearing is scheduled for next week, according to the court docket. Asked whether it anticipates that the deal will be approved, a GA Telesis spokesperson said: “YES — We have full intention as does Spirit to continue with the transaction as documented.”

Spirit did not immediately respond to emailed questions about the stock, retention bonuses, aircraft deal and whether travelers might be booking away from the airline.

Bondholders in control

As outlined by Cromer in his declaration to the court, approximately $1.635 billion of outstanding funded debt would be restructured and the company’s total funded debt would decline by approximately $795 million with the lenders collectively receiving $840 million in secured notes and new common stock in the reorganized company. The lenders are, in effect, holding most of the cards, analysts say.

The airline is emphasizing a “business as usual” posture, stating that employees, vendors, landlords and anyone else doing business with the company will be paid on time during the Chapter 11 proceedings while the airline flies the schedule it laid out for the fourth quarter of this year. It currently serves more than 80 destinations in the U.S., Latin America and Caribbean.

“In sum,” Cromer wrote, “Spirit seeks to implement a financial restructuring that positions it for future stability, growth, and success without impacting its vendors or other commercial counterparties and without interrupting its ability to serve its guests during the Chapter 11.”

As of the Chapter 11 filing, Spirit employed approximately 12,800 “direct employees,” approximately 84% of them unionized. They include approximately 3,400 pilots, 5,800 flight attendants, 740 aircraft maintenance technicians, 400 ramp service employees, 330 customer service agents, and 100 flight dispatchers. Their labor agreements would remain intact. The airline contracts out work to nearly 10,000 other workers.

Encroachment by rival airlines

After evolving from a trucking company into a charter airline in Michigan in 1990, Spirit relocated to South Florida in Miramar in 1999 and started operating as an “ultra low-cost carrier” offering customers rock bottom “unbundled” base fares. If they wanted anything else such as checked baggage, seat assignments, priority boarding, refreshments, or Wi-Fi, they would pay for those services a la carte. Spirit used those low fares “to address underserved markets, which helps it to increase passenger volume and load factors on the flights it operates,” Cromer noted in his court declaration.

The business went well until COVID-19 all but grounded the industry in 2020, a year that saw most of the industry seek financial aid from the U.S. Government.

“As the seventh largest carrier in the United States, Spirit was not immune to the macroeconomic effects of the COVID-19 pandemic, an oversupplied domestic market, and larger rivals who have capitalized on premium and cost- conscious travelers alike,” Cromer wrote in his court declaration. “In the post- pandemic period, the U.S. airline industry has seen material change as a result of shifting customer demand and operating headwinds.”

“Business travel through 2023 had not fully returned to pre-COVID volumes,” Cromer added, and “premium leisure demand soared which, in combination with unbundled fare competition,” allowed carriers such as Delta and Southwest to “compete for an even greater portion of basic economy share” held by ultra low-cost carriers such as Spirit.

The airline has cut back its route network as it has sought to slash costs ahead of the Chapter 11 filing. Other airlines including discounters Frontier and Allegiant Air have since added routes in and around Spirit’s traditional Florida airspace. In the meantime, the so-called “Big Four” carriers that dominate 80% of the U.S. market — Delta Air Lines, American Airlines, United Airlines and Southwest Airlines — have been offering their own economy fares.

In a note to investors, Raymond James analyst Savanthi Syth wrote that Spirit’s capacity cuts for November and December along routes that overlapped with other carriers largely benefited Frontier, JetBlue and Minneapolis-based Sun Country, with lesser traffic gains by Alaska Airlines and Southwest.

Project Bravo

In a bid to drive more revenue, Spirit hopes to attract new customers with an upscale program of newly tiered fares and services unveiled over the summer. Dubbed in the court filing as part of a strategic overhaul called “Project Bravo,” the company has new premium offerings for customers that became available in August. They included four new travel options called “Go Big,” “Go Comfy,” “Go Savvy,” and “Go,” the latter of which is the airline’s original base fare category.

In effect, the more passengers pay, the more options they’d receive including free Wi-Fi, cabin baggage, snacks and drinks, “all with the flexibility of no change or cancel fees,” Cromer wrote.

Spirit would also add larger overhead bins and introduce premium cabins with access to free streaming Wi-Fi. People holding premium tickets would have dedicated wait lines at some airports; overall, the airline would seek to simplify boarding zones in its terminals.

The airline is already realigning its route system, dropping less profitable destinations in favor of so-called “top value seeker” cities.

The airline would also renew its focus at Fort Lauderdale-Hollywood International Airport, where it stands No. 1 in passengers carried. More “focus cities” would be added in early 2026 where management thinks it could exercise more pricing power.

But bigger airlines such as Delta think they’re dealing with a better hand than discounters when it comes to premium services. On an investor call, Delta President Glen Hauenstein took an indirect shot at Spirit, saying larger carriers with premium products “had a little bit of a downdraft” after the pandemic versus airlines focused on price.

“I think we’ve seen that manifest itself in the bankruptcy we saw filed this week,” he said.

Another takeover play?

Cromer in his declaration acknowledged that Spirit had renewed merger talks with Frontier before the bankruptcy filing, but they went nowhere.

“Over the last few months, the Company and Frontier restarted negotiations around a possible merger transaction,” he wrote. “In recent weeks, certain members of the Ad Hoc Groups were made aware of such discussions as well. Those discussions were discontinued and are no longer ongoing.”

Frontier has declined comment.

Earlier this year, after a Boston federal judge killed a proposed $3.8 billion takeover of Spirit by JetBlue Airways on antitrust grounds, the company’s stock value plunged by 60%, Cromer said. It was an event that triggered management’s effort to start exploring all of its financial options, while simultaneously figuring out how to drive new business.

Henry Harteveldt, founder and president of Atmosphere Research, a San Francisco-based consulting firm, said another round of buyout talks during the bankruptcy case is not out of the question.

“Nothing is stopping Frontier, or, for that matter, any other airline, from opening discussions,” he said.

“Another option,” Harteveldt said, is that other airlines could ask Spirit about acquiring other planes, airport gates or landing slots, or even pilot training facilities.

The outcome

Whether a Spirit Airlines with a lighter debt load and new marketing strategy will emerge from Chapter 11 equipped to become profitable remains to be seen. Joseph “Joey” Smith, an investment banker and aviation specialist at Cassel Salpeter & Co. in Miami, believes the carrier’s history as an industry disrupter will be an important asset going forward.

“How they’ve been operating to date looks like they are really trying to shake things up again,” Smith said. “And I give them credit for that. I have admiration for somebody who is being true to their founding DNA. I think it will be interesting.”

This article has been updated to include the full attribution for the Cassel Salpeter
& Co. aviation specialist.

Originally Published: November 25, 2024 at 5:00 AM EST

 

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Navigating a Biotech Exit in a Rebounding Market

 

By Ana Mulero
November 6, 2024

With climbing biotech M&A and IPO activity following the post-pandemic slump, experts offer insights on maximizing value and otherwise capitalizing on exit opportunities.

What Investors Are Looking For

Investors are prioritizing quality over quantity in clinical data and seeking companies whose leadership teams have proven track records, which are crucial for future exits that deliver returns.

These shifting investor priorities emerged as biotech companies navigated the challenging environment that followed the acute phase of the COVID-19 pandemic. Cody Powers, principal at ZS Associates, noted that many companies have been patiently waiting for the right moment to make their move. “The companies that survived the tough past few years were biding their time waiting for the IPO window to open” and are ready to seize IPO opportunities, with capital, investor enthusiasm and bank readiness all aligned, Powers told BioSpace. “We’re not in a bubble [anymore]; it’s the opposite—a lot of companies are lined up . . . ready to declare for IPOs, and this is exactly what happened.”

Kyverna Therapeutics closed 2024’s second-largest biotech IPO in February. Preparations began in September 2023 once the clinical-stage company collected post-treatment data on KYV-101, its CD19-targeted CAR T cell therapy for autoimmune diseases such as lupus nephritis and myasthenia gravia, as this was a key part of its exit strategy, former CEO Peter Maag told BioSpace. In September 2023, post-treatment data for lupus nephritis revealed no cases of immune effector cell–associated neurotoxicity syndrome—a known risk associated with CAR T cell therapy—in patients taking KYV-101. In November of that year, Kyverna reported collecting real-world patient data in the clinic, which ultimately contributed to the FDA’s clearance for a Phase II trial, Maag said.

“It was important to our IPO to be able to generate real-world patient data,” he told BioSpace. “Our goal was to provide initial evidence of comparable effect in autoimmune patients, but with a more acceptable risk profile.”

The Gilead-backed cell therapy startup Kyverna ultimately raised nearly $367 million in its upsized IPO. In September, Kyverna announced Maag’s resignation from his role and the board. He was succeeded by Warner Biddle, who most recently held senior commercial roles at Gilead’s Kite Pharma after a prominent career at Genentech. Christi Shaw, Kite Pharma’s former CEO, also joined the board as part of the transition to the new development phase of the KYV-101 program.

Ira Leiderman, healthcare managing director at investment banking firm Cassel Salpeter, said leadership with prior wins is seen as an indicator of a company’s ability to achieve similar market success, and added that the data must not only be good, but the potential markets big. Biotech investors are increasingly seeking “rock-star management teams and a clear path toward blockbuster therapies, not just niche products.”

Andrew Lam, managing director and head of biotech private equity at Ally Bridge Group, pointed to CG Oncology, the first biotech to go public in 2024, which raised an upsized IPO of $380 million in January. “[CG’s] strong management, excellent clinical data and significant investor backing made their IPO the largest of 2024,” Lam told BioSpace. Ally Bridge had supported CG since its series A financing round, when it invested $13.6 million and then became a significant shareholder after the biotech went public.

“[CG] is the most successful IPO of the current class of 2024,” Lam said. That’s because the company had a strong investor syndicate in its crossover round and differentiated data.

Jakob Dupont, executive partner at Sofinnova Investments, told BioSpace that leadership teams with expertise in finance and clinical development are of particular value. He highlighted the recent successes of the biotech firms that Sofinnova has supported, including startup RayzeBio.

Established in 2020, radiopharma-focused, clinical-stage RayzeBio was considered to have a rockstar leadership team with experience across the biotech, finance and pharmaceutical sectors. Key figures included former President and CEO Ken Song—who previously led Ariosa Diagnostics, acquired by Roche in 2016, and now leads Candid Therapeutics, which made its debut in September to position itself as a T cell engager market leader—and former CMO Susan Moran, who previously held leadership positions at Sanofi, Takeda, Puma Biotechnology and BridgeBio. Following closing its upsized $311 million IPO in September 2023, RayzeBio was acquired in February by Bristol Myers Squibb for $4.1 billion. The crown jewel of the acquisition was RayzeBio’s actinium-based targeted radiopharmaceutical candidate, RYZ101, which is in Phase III development for treating gastroenteropancreatic neuroendocrine tumors.

Powers noted current investor focus on leadership is part of a larger shift from investing based solely on confidence in the science to a longer-term view, recognizing that solid science does not always guarantee market success. Early-
stage investors, influenced by the formerly stagnant M&A environment, now understand that science alone is not enoug —they must also account for factors like pricing and manufacturing challenges that could limit a therapy’s potential, according to Powers. “These considerations beyond just the strength of the science are now front and center,” he said. The investor landscape “is more nuanced, with a broader set of factors to consider than before.”

Practical Tips for Executing a Biotech Exit

Experts recommend adopting a multi-pronged approach to exit strategies to enhance their chances of success, particularly by optimizing outcomes during the exit process, made easier by leveraging successful investor funding strategies. These include exploring diverse options, being open to down rounds, considering selling royalties and building strong investor syndicates.

Don’t put all your eggs in one basket.

Biotech companies should explore various exit strategies simultaneously, experts recommended, noting that this approach has become a new trend in the industry. Companies are increasingly recognizing that pursuing multiple exit options at the same time can attract more interest from potential buyers and investors, ultimately enhancing their chances of a successful exit.

“Biotech stories are rarely linear and there are more often than not large bumps in the road,” Kale Frank, managing director of Silicon Valley Bank’s life science and healthcare division, told BioSpace. “The more resources you have at your disposal and the more options you can have on the table, the more you will be able to smooth out some of those bumps.”

Powers noted that most high-profile M&A exits involve public companies that went through IPOs to better position themselves for acquisition by larger firms. For private companies, the decision between an IPO and M&A often depends on whether they have long-term growth potential, he added. But he noted that with renewed investor optimism, companies are more willing to put off a potential exit, sometimes accepting smaller funding rounds while keeping hopes for an IPO or preserving long-term value.

Frank added that “the savviest management teams are for sure looking at all options, but also thinking about ways to increase their probability of success. They have more levers to pull, both if things go well and if things don’t go according to plan A.”

Be open to a down round.

Frank argued that private companies may sometimes need to resort to down rounds—when capital is raised at a valuation lower than the previous financing round—to secure funding and move forward. Down rounds, while not ideal, can keep companies operational, allowing them to hit key milestones and improve outcomes in better market conditions.

Consider selling royalties.

Royalty financing has become an increasingly popular alternative to equity- dilutive funding options like venture capital and IPOs, as it allows companies to raise capital based on future revenue-sharing agreements, Brad Sitko, chief investment officer at XOMA Royalty, previously told BioSpace. Striking royalty deals can also help ensure financial readiness by providing immediate capital, reducing financial risk and strengthening the company’s positioning during exit negotiations, he said.

Sitko argued that opportunities in royalty monetization enable companies to access capital by selling future royalty streams despite emerging challenges in securing adequate financing, such as greater investor selectiveness. “This financing tool, combined with exit trends, suggests a potential reversal of [rising] biotech bankruptcies,” Stiko said.

Build a strong investor syndicate.

Just like CG, companies should diversify their investor base by building a strong syndicate of crossover investors who can provide financial support before and after an IPO, DuPont said. Having crossover investors with the resources to reinvest after the IPO ensures stability and fosters continued growth.

Maag added that Kyverna drew in the appropriate investors after its successful extension of a series B financing in August 2023, establishing a solid groundwork for its expansion. The company’s focus then shifted to strategically outlining long-term financing, Maag further noted.

“This marks my second IPO in my professional career, and every time it is a very different ball game,” Maag said. His first IPO was with Miromatrix Medical, which raised $49.7 million in June 2021; this set the stage for the company’s two- step acquisition by United Therapeutics in December 2023, highlighting a common M&A strategy for full integration within about 2.5 years.

Focus on the short term.

Maag also emphasized the importance of prioritizing near-term inflection points in biotech exit strategies. Achieving such upcoming milestones or events, which typically include key clinical trial results, regulatory approvals or significant partnership announcements, can drastically increase a company’s value and make it a more appealing target for acquisition or investment.

As such, Maag said companies often plan their exit strategies around these milestones to maximize their valuation and attract interest from potential buyers or investors. “Focus on developing a set of initiatives that keep adding immediate value to your business proposition and let clinical data showcase your value creation potential to investors,” Maag added.

Ana Mulero

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

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

 

By DAVID LYONS | South Florida Sun Sentinel

November 3, 2024 at 4:00 AM EST

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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