5 Life Sciences IPOs in 2023—and the Future Forecast

 Compared to recent years, 2023 has been a relative desert—or a winter—in terms of biotech IPO offerings. In 2022, for example, 47 IPOs raised a total of about $4 billion, while in 2021, 152 offerings brought more than $25 billion to the market, Reuters reported. So far this year, only 23 IPOs have been filed, according to DealForma, an online platform that tracks deals across the biopharma industry. The 12 that have since been completed have netted $1.6 billion, excluding the record-breaking $41 billion IPO filed by Johnson & Johnson’s Kenvue in May.

“Two years ago, almost anything went public, even things that shouldn’t have,” David Diamond, a managing director overseeing life sciences and technology companies for the business consulting firm CBIZ MHM, told BioSpace. “But this year, it’s basically been dead.”

Such boom-and-bust cycles are not without precedent, and previous disruptions occurred in 1987, 2000 and 2007. During these cycles, the market enters a sort of euphoria, Diamond said, and funders and businesses alike spend lavishly on products that ultimately fall flat. During the height of the COVID-19 pandemic, the market rode a renewed interest in biomedicine and owners took companies public based on preclinical findings, only to run afoul of an economic downturn heading into last year. Since then, aggressive interest rate hikes by the Federal Reserve have made investors wary, with venture capital and early-stage biopharma funding down by 30% and 40%, respectively, compared to 2022.

In this new, cooler phase, Diamond said to expect a return to investors focusing on companies that can back their products with results from Phase II or even Phase III clinical trials. So far, the year’s few IPOs bear this out—Acelyrin, which raised a massive $540 million in an initial public offering in May, was in Phase IIb/III testing at the time, while Sagimet Biosciences released interim Phase IIb data from its lead candidate denifanstat in nonalcoholic steatohepatitis (NASH) at the same time it announced its IPO in June.

But while it has been a slow year, there is evidence that the space is heating up once again, said Chris Dokomajilar, founder and chief executive of DealForma. Roughly half of the companies with active IPOs filed in July and August, and other experts, have similarly pointed to a projected uptick in activity between Labor Day and Thanksgiving, when up to 10 companies may go on offer, according to Endpoint News. Afterward, there will likely be another lull ahead of next year’s JP Morgan Healthcare Conference, held January 8-11 in San Francisco, when many companies make their IPO announcements, Dokomajilar told BioSpace. “There’s hope that things are going to turn, and the rush is really on for 2024,” he said.

Here's a look at five companies who have filed IPOs so far this year.

* indicates the dollar amount is subject to change

      1. RayzeBio Inc.

Amount: $311 million

RayzeBio, a targeted radiopharmaceutical company based out of California, RayzeBio announced pricing for its IPO on September 14. In May 2023, it dosed its first patient in a Phase III trial of its lead therapeutic candidate, RYZ101, being developed for the treatment of gastroenteropancreatic neuroendocrine tumors. The drug is also in Phase I testing for small cell lung cancer, and the company said in a press release that it is on track to be the first approved radiopharmaceutical therapy that uses Actinium-225—a cancer-busting radioisotope so rare that the annual global production is less than a grain of sand.

2. Neumora Therapeutics

Amount: $250 million

Neumora Therapeutics—a Massachusetts-based drug development company focused on psychiatric disorders—is moving at a steady clip. The company announced pricing for its IPO on September 14, a little less than two years after launching. Its leading drug candidate, navacaprant, was shown in a Phase II study to reduce symptoms of depression and anhedonia in participants with moderate-to-severe major depressive disorder, and the drug is currently entering Phase III testing. The company expects to release results later in 2024 and submit a New Drug Application in 2025.

      3. Adlai Nortye

Amount: $72 million

Although the company filed confidentially for its IPO in December 2022, the announcement became public on July 31 of this year, and the amount was later reduced from $115 million to $72 million. Incorporated in the Cayman Islands and run through subsidiaries in the U.S. and China, Adlai Nortye focuses on treatments for cancer and metabolic diseases. One candidate, AN2025, is currently in Phase III clinical trials for head and neck squamous cell carcinoma, and the company hopes to file for FDA market approval by the end of 2024. In its SEC filing, Adlai Nortye noted that the Japanese chemical conglomerate Nippon Kayaku has agreed to buy $40 million in shares concurrent with the IPO, while an unnamed potential investor has also expressed interest in purchasing up to $50 million in shares.

      4. Jyong Biotech

Amount: $40.25 million

Jyong Biotech, a company incorporated in the Cayman Islands but with subsidiaries in Taiwan, Singapore, Hong Kong and China, recently began an IPO rollout in the U.S. A late-stage startup interested in plant-based treatments for urinary system diseases, Jyong Biotech has run its leading candidate, MCS-2, through four Phase III trials as a treatment for benign prostatic hyperplasia (the market for such a treatment is expected to top $11.9 billion by 2031). Despite the obvious need, some investors remain wary, as the company is currently working with an outside statistical team to rework certain data to conform with FDA statistical analysis standards before it can apply for regulatory approval.

      5. Metagenomi

Amount: Unknown

Although no official announcement has been made, Endpoints News recently reported that the California-based company, which focuses on treating diseases using gene-editing technology, is currently working with the investment bank JP Morgan on a potential fall IPO listing. Metagenomi has already amassed more than $400 million through venture capital funding and partnerships with biopharma companies such as Moderna and Ionis. However, unlike the other companies on this list, its platforms remain in the preclinical phase.

https://www.biospace.com/article/5-life-sciences-ipo-in-2023-and-the-future-forecast-/

Amgen-Horizon Merger Clearance a Setback to FTC’s Antitrust Enforcement Plans

In a settlement on September 1, the U.S. Federal Trade Commission cleared Amgen to proceed with its $27.8 billion acquisition of Horizon Therapeutics after several months of scrutiny. Some experts say the agreement is a setback for the agency.

The Federal Trade Commission (FTC’s) decision to settle the Amgen/Horizon case through a “behavioral remedy” is the latest in a series of setbacks to the regulator’s stated goal of stricter antitrust enforcement, a notable decision with significant implications for ongoing and future FTC M&A challenges, according to two antitrust lawyers who spoke to BioSpace. 

“This decision by the FTC appears to be a recognition on the part of the FTC that it faced an uphill climb to persuade a district court judge to block the transaction outright on a novel legal theory of harm,” said Jeny Maier, an antitrust partner at Axinn, Veltrop & Harkrider LLP.

“[It] is notable because of [FTC] Chair [Lina] Khan’s vocal critiques of behavioral remedies’ effectiveness in addressing harms from mergers,” Maier added. “Indeed, she testified before the Senate last year saying, ‘We now strongly disfavor behavioral remedies.’”

The FTC’s Case

The Amgen-Horizon buyout, announced in December 2022, was halted in May 2023 due to a lawsuit filed by the FTC over concerns that the acquisition might suppress competition. In an unusual twist for merger challenges, the agency’s case against Horizon and Amgen did not hinge on claims of competing products or potential future competition. Instead, the focus was on the potential for Amgen to include Horizon's blockbuster drugs in its rebate program.

The FTC’s complaint centered on two Horizon products: Tepezza and Krystexxa. Tepezza is the only FDA-approved treatment for thyroid eye disease (TED), while Krystexxa is the sole FDA-approved product for chronic refractory gout (CRG). 

Despite facing little to no competition, the FTC argued that Horizon anticipated increased competition from clinical-stage rivals in the near future. Given its substantial biopharmaceutical portfolio, including nine products with over $1 billion in sales each in 2022, the FTC’s concern was that the acquisition could shield Horizon from this anticipated competition.

Amgen, on the other hand, has argued consistently that its acquisition of Horizon is only an opportunity to expand its rare disease portfolio and that it has no plans as to stifle market competition. To formalize these assertions, Amgen has agreed to enter into an FTC consent order agreement that prohibits it from bundling any of its products with either Tepezza or Krystexxa, among other requirements. 

Following an executive order in July 2021, the Biden administration has taken a more aggressive approach to antitrust enforcement, with both the FTC and the Department of Justice pursuing cases to address competition issues in various sectors, including the pharmaceutical ecosystem, which has been a major target of late. 

On August 25, the U.S. Court of Appeals for the District of Columbia Circuit dismissed an FTC lawsuit alleging that an agreement between Endo Pharmaceuticals and Impax Laboratories for the opioid Opana ER (oxymorphone extended release) violated antitrust law. 

In dismissing the FTC’s claim against the pharmaceutical companies, the court cited insufficient factual allegations to support the lawsuit. 

George Gordon, a partner at Dechert LLP who argued the appeal for Endo, said in a statement that this ruling is “particularly significant in an antitrust enforcement environment that has become increasingly hostile to, and suspicious of, the exercise of patent rights.”  

Going Forward: What to Expect

“The outcome in [the Amgen case] provides further support for merging parties’ strategy of making unilateral commitments to defuse the harms claimed by the FTC or DOJ,” Maier said. 

She further added that Amgen’s successful use of this strategy follows a similar path as in Illumina/Grail and Microsoft/Activision Blizzard. In both cases, the FTC initially lost its challenge and both are currently in appeal. 

This could indicate that the FTC may be looking for similar conduct remedies in future pharmaceutical deals even when the claimed competitive harm is less than clear, Jonathan Lewis, an antitrust partner at Lowenstein Sandler LLP, told Biospace. 

Notwithstanding the FTC’s acceptance of a settlement in the Amgen/Horizon matter, dealmakers in the pharmaceutical sector should continue to expect the FTC to explore novel theories of harm in merger investigations, Maier said. 

As highlighted in Chair Khan’s written statement accompanying the Amgen settlement announcement, Maier said the FTC is very focused on digging deeper into pharmaceutical markets to understand connections between mergers and drug company conduct it perceives to be anticompetitive. 

“The FTC’s keen interest in these markets will continue to mean potentially longer regulatory review timelines for high-profile and high-value transactions in the industry,” Maier stressed. 

Ongoing FTC Challenges: Pfizer/Seagen

The FTC and European antitrust authorities are currently scrutinizing Pfizer's $43B acquisition of Seagen, so far the most significant biopharma deal of 2023. In July, the U.S. antitrust watchdog requested additional information as part of it investigation of the merger. 

“We recognize the need to examine with particular scrutiny proposed mergers that may result in lessening of competition and higher prices for consumers. We remain diligent in protecting the American public from these potential harms,” said the FTC’s Alicia Dubuc, Competition Policy International reported. 

The buyout stands as the industry’s largest M&A deal since AbbVie’s acquisition of Allergan for $63 billion in June 2019. Should the deal materialize, Pfizer will have access to four approved products and a robust pipeline of antibody-drug conjugate candidates. The New York–based company projected that the products acquired from Seagen would contribute an additional $10 billion in annual revenues by 2030. The acquisition is expected to be completed between the end of 2023 and the beginning of 2024. Notably, Seagen’s major shareholders have already given their approval for the buyout, leaving its fate in the hands of the FTC. 

In merger challenges, conduct remedies are rare and not preferred, Lewis said. Instead, the preference is a divestiture to resolve the competitive concern. In light of this trend, he said that pharmaceutical companies should reconsider their bundling programs and obtain advice on ‌antitrust implications. 

https://www.biospace.com/article/amgen-horizon-merger-clearance-a-setback-to-ftc-s-antitrust-enforcement-plans-/

FBI lost count of how many paid informants were at Capitol on Jan. 6, audited for exact number: ex-official

The FBI had so many paid informants at the Capitol on Jan. 6, 2021, that they lost track of the number and had to perform a later audit to determine exactly how many “Confidential Human Sources” run by different FBI field offices were present that day, a former assistant director of the bureau has told lawmakers.

At least one informant was communicating with his FBI handler as he entered the Capitol, according to Steven D’Antuono, formerly in charge of the bureau’s Washington field office.

D’Antuono has testified behind closed doors to the House Judiciary Committee that his office was aware before the riot that some of their informants would attend a “Stop the Steal” rally thrown by former President Donald Trump but he only learned after the fact that informants run by other field offices also were present, along with others who had participated of their own accord.

The Washington field office had to ask FBI headquarters “to do a poll or put out something to people saying w[ere] any CHSs involved,” he said, so they could get a handle on the scale of the FBI’s spying operations at the Capitol that day.

“We started getting responses back” from FBI headquarters, added D’Antuono, which helped identify which field offices had planted confidential informants in the crowd. 

According to a former FBI official, the bureau had to conduct an audit to find out how many paid informants it had at the Capitol riot on January 6, 2021.

AP Photo/Jose Luis Magana, File

One paid informant from the Kansas City field office was at the Capitol as the crowd surged inside and allegedly was in communication with his FBI handler, “while they were in the crowd, I think, saying that they were going in,” according to the former bureau brass.

“They were trying to stop some of the action happening and they left or whatnot.”

Asked how many informants the audit discovered were in the crowd that day, D’Antuono would only say “a handful”.

The FBI spends an average of $42 million each year in payments to its Confidential Human Sources, according to the Department of Justice Office of Inspector General, which has raised concerns about the vetting process for these paid informants.

Steven D’Antuono, the former head of the FBI Washington field office, said that there was “a handful” of paid informants at the Capitol.

Sarah Silbiger/Pool via REUTERS

In a letter to FBI Director Christopher Wray Tuesday, Judiciary Committee Chairman Jim Jordan (R-Ohio), described D’Antuono’s testimony as “extremely concerning”.

It suggests that “the FBI cannot adequately track the activities and operations of its informants, and that it lost control of its CHSs present at the Capitol on January 6,” he wrote.

“These revelations reinforce existing concerns, identified by Special Counsel [John] Durham, about the FBI’s use of, and payment to, CHSs who have fabricated evidence and misrepresented information.

“The Justice Department Inspector General also identified critical problems in the FBI’s CHS program,” Jordan added, “including the FBI’s failure to fully vet CHSs and the FBI’s willingness to ignore red flags that would call into question an informant’s reliability.”

Trump supporters clash with police and security forces as they storm the US Capitol in Washington, DC, on Jan. 6, 2021.

AFP via Getty Images

Jordan has asked Wray to provide a “substantive briefing” on how the FBI used paid informants on Jan. 6, 2021, and “any specific guidelines or admonishments that were provided to FBI CHSs prior to deploying”.

Wray has also been asked to provide all debriefing documents received from Capitol riot informants.

Jordan also wants source reporting documentation relating to former British spy Christopher Steele, who was responsible for a now-notorious “dossier of false allegations about the Trump-Russia hoax.”

The number of FBI informants present during the Capitol riot has long been a controversial topic at trials of the hundreds of defendants apprehended since that day.

According to D’Antuono, at least one informant was communicating with a FBI handler as he was entering the Capitol building.

REUTERS/Ahmed Gaber/File Photo
Defense lawyers at the trial of five “Proud Boys” recently asserted that the FBI had as many as eight informants spying on the organization and that at least one was with them at the Capitol that day.

Former Capitol Hill Police Chief Steven Sund has said that, in addition to the paid informants, the FBI had at least 18 undercover agents in the crowd plus an estimated 20 from the Department of Homeland Security

https://nypost.com/2023/09/19/fbi-lost-count-of-number-of-informants-at-capitol-on-jan-6-ex-official/