BioNTech SE

Late Monday, Summit Therapeutics issued a “going concern” warning in its quarterly earnings filing, a disclosure more common with biotechs circling the drain after major failures — not a $20 billion market cap darling that’s at the forefront of one of the sector’s hottest cancer modalities. But Summit, which has $298 million in cash and equivalents, according to an SEC filing, has been quickly burning cash to run global trials of its PD-1xVEGF antibody ivonescimab and bring it to market. That led the company’s auditors to add the warning that Miami-based Summit has less than 12 months of cash available to pay expenses. It’s rare, perhaps “unprecedented,” for that accounting lingo to show up in the quarterly disclosure of a biotech like Summit, Cantor analysts wrote in a Tuesday note to clients. But it’s also likely of little cause for concern, said the analysts, who noted that Summit has “plenty of options” to bring in more money. It’s also not the first time the company has issued the warning. “But the going concern language does highlight management’s highly unconventional approach towards capitalizing the company,” the Cantor analysts continued. “Historically, most $20B biotech companies carry billions in cash reserves.” The Cantor analysts said it can be an interpretation of “ownership” culture in Summit’s C-suite. The company hasn’t overcapitalized like many other biotechs and there “appears to be no hedging of bets or stocking up on cash for a rainy day.” Since early 2023, Summit has had the ex-China rights to Akeso-partnered ivonescimab. The drug has been approved for certain cancer indications in China. After ivonescimab topped Merck’s Keytruda in a pivotal trial in May 2024, the pharma industry went on a shopping spree to find similar assets in the space. BioNTech bought its Chinese biotech partner and then flipped that into a major partnership with Bristol Myers Squibb just months later. Merck licensed a program from China-based LaNova Medicines . Pfizer licensed a program from Chinese biotech 3SBio . Other biotechs are in the mix . And AstraZeneca has reportedly shown interest: The UK pharma giant was in talks with Summit about a potential $15 billion licensing deal, Bloomberg News reported in early July. If it needs more cash in the short term, Summit could tap into existing registered stock offerings, which would let it quickly sell more shares. It increased the amount available to sell by $360 million on Monday, but said it’s not obligated to sell . The upsized at-the-market offering “could provide the company with temporary alleviation of their cash overhang, but it does not preclude the need to partner” on ivonescimab, Leerink Partners analysts wrote in a note to clients on Tuesday. Summit’s stock price $SMMT was down 11% in Tuesday afternoon trading, possibly because the company hasn’t locked up its plans to submit the drug to the FDA for US approval. “At present time,” Summit plans to ask the FDA to approve ivonescimab based on results from a trial that read out a few months ago. But Summit is still considering when it will submit that approval request, the company reiterated in Monday’s quarterly update , echoing comments it made in May.

Pfizer is in talks with the FDA about a path forward for its pediatric vaccine and has asked that the emergency use authorization in kids under 5 years of age stay in place for the 2025-26 season. The ability to inoculate young children against COVID-19 in the U.S. may be diminished this fall as the FDA weighs whether to renew the emergency green light for the vaccine currently cleared in the broadest group of kids.“The FDA has communicated to Pfizer the intent to potentially not renew emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine for individuals aged 6 months through 4 years,” a Pfizer spokesperson told Fierce Pharma over email.The company is in talks with the regulator about a path forward for its pediatric vaccine and has asked that the emergency use authorization (EUA) in kids under 5 years stay in place for the 2025-26 season, the spokesperson added.“It is important to note that these deliberations are not related to the safety and efficacy of the vaccine which continues to demonstrate a favorable profile,” the spokesperson continued.Given the potential change to the pediatric vaccine landscape for COVID-19, Moderna is reportedly working with the U.S. Centers for Disease Control and Prevention (CDC) to step up supplies of its own mRNA-based shot for COVID prevention in kids, The Guardian first reported.The CDC is in discussions with Moderna to rapidly increase its pediatric COVID vaccine supply, working through considerations like volume, shipment timing and potential supply gaps, The Guardian reported, citing information gleaned from an email sent out by the CDC’s National Center for Immunization and Respiratory Diseases last week.A Moderna spokesperson told Fierce Pharma over email that it anticipates being able to step up supplies of its vaccine. Crucially, Moderna’s shot is approved for use in people between 6 months and 64 years of age, but only in those with one or more health conditions that puts them at increased risk of COVID-19. The vaccine is also approved in all people ages 65 and older.Pfizer’s pediatric EUA does not come with the same stipulation concerning recipients' underlying health conditions.“The COVID-19 pandemic ended with the expiration of the federal public health emergency in May 2023,” said a spokesperson for the Department of Health and Human Services (HHS), which oversees the FDA.“We do not comment on potential, future regulatory changes,” he said. “Unless officially announced by HHS, discussion about future agency action should be regarded as pure speculation.” The potential change coincides with various actions under Robert F. Kennedy Jr.’s HHS that some industry watchers have taken as a sign of growing anti-vaccine sentiment within the U.S. federal health apparatus.Back in May, FDA Commissioner Marty Makary, M.D., and Center for Biologics Evaluation and Research chief Vinay Prasad, M.D., laid out a new “evidence-based approach to COVID-19 vaccination” that proposed stricter requirements for future COVID shot approvals.Shortly after that, the CDC overhauled its vaccine recommendations in COVID, nixing its endorsement of the shots for pregnant women and healthy children. At the time, RFK Jr. said he “couldn’t be more pleased” about the decision and cited a lack of “clinical data to support the repeat booster strategy in children.” If the FDA chooses not to renew Pfizer’s pediatric vaccine EUA, the shots available for young kids will be more limited in the U.S. Aside from the limitations on Moderna’s pediatric label, Novavax’s protein-based COVID-19 vaccine is only approved in people ages 12 and older. Pfizer and BioNTech's vaccine carries a full approval for use in people 12 and older, too.

iStock, Gajus The stop order came on Aug. 5, the same day Health Secretary Robert F. Kennedy Jr. terminated 22 mRNA vaccine projects under the Biomedical Advanced Research and Development Authority, though Vaxart’s candidate is protein-based. The Department of Health and Human Services has slapped vaccine manufacturer Vaxart with another stop order for its next-generation oral COVID-19 vaccine, which the California-based company was developing with support from the federal government. According to an SEC document on Aug. 5 , Vaxart was told to stop screening and enrolling patients into a Phase IIb trial for VXA-CoV2-3.3, an investigational pill designed to elicit broad protection against variants of the SARS-CoV-2 virus. Vaxart can “continue efforts associated with the per protocol follow-up for the 10,000-person cohort, to the extent already dosed,” as per the regulatory filing. The biotech has so far enrolled around half of its target participants. HHS did not give Vaxart a reason for the order, only indicating that it will release a “follow-up notice with further details,” according to the SEC document. Vaxart is working on the mid-stage trial with funding from the Biomedical Advanced Research and Development Authority (BARDA), which gave the biotech an award of up to $460 million . VXA-CoV2-3.3 is an orally available S-protein COVID-19 vaccine that, according to the biotech’s website , is designed to elicit durable immunity against the virus. Preclinical data additionally showed that the immunizing pill can also lower airborne transmission by minimizing viral shedding. In its mid-stage study , Vaxart aims to compare VXA-CoV2-3.3 with Pfizer and BioNTech’s mRNA-based vaccine Comirnaty across more than 10,000 patients. The company started dosing in May and expects the trial to wrap up in November 2026. The program has had a rough couple of months, however, with HHS in February issuing a similar stop order to review its initial findings. The freeze was lifted in April. Beyond Vaxart, Health Secretary Robert F. Kennedy Jr. has enacted many other policy changes that are in line with his well-documented history of vaccine criticism. Most recently, Kennedy canceled some $500 million—corresponding to 22 projects—in BARDA contracts for mRNA vaccines. Incidentally, this move came on Aug. 5, the same day the new stop work order for Vaxart’s protein-based vaccine was handed out. Kennedy in late July also said that he would “fix” the U.S. Vaccine Injury Compensation Program, claiming that the system has “devolved into a morass of inefficiency, favoritism, and outright corruption.” It is unclear what exact changes he is considering. In May, Kennedy also removed routine COVID-19 vaccination from the CDC’s guidelines for healthy children and healthy pregnant women—a move that a coalition of medical societies blasted in July as a “baseless and uninformed policy decision.”