LaNova Medicines Ltd.

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.

A Chinese biotech developing a PD-1xVEGF bispecific and other antibody-drug conjugates has secured a nine-figure raise from blue-chip investors. Shanghai-based Minghui Pharmaceutical raised $131 million in what it called a “pre-IPO” financing, the company announced Thursday. The round was co-led by OrbiMed, one of the biggest life science investors in the US, and Qiming Venture Partners, the China-based firm that routinely invests in the country’s early-stage science. The PD-1xVEGF bispecific field has been hot lately thanks to Summit and Akeso, whose drug ivonescimab is undergoing Phase 3 studies in lung cancer. Some of the trials based in China showed it to be superior to Merck’s best-selling immunotherapy Keytruda, but the data have been less straightforward when tested in Western patients . Nonetheless, the data are attractive enough that Summit has had discussions with AstraZeneca about a potential $15 billion deal, according to a report last month from Bloomberg . Those talks followed another high-profile deal in the space: Bristol Myers Squibb teamed up with BioNTech in an agreement that could be worth more than $10 billion. Pfizer has also jumped into the space, partnering with 3SBio in a deal that closed last month and could be worth more than $6 billion. Merck licensed a PD-1xVEGF bispecific last year as well from LaNova Medicines that could see Merck on the hook for more than $3 billion. In Thursday’s press release , Minghui said its new funds will go “with a particular focus” toward its own PD-1xVEGF bispecific, which is called MHB039A and is currently in Phase 2 trials. Last November, Minghui said it was “exploring strategic partnerships” for the program after reading out Phase 1 dose-escalation data. Minghui also noted that the bispecific is being tested in combination with an unnamed TROP2-directed antibody-drug conjugate. The biotech’s other pipeline programs include a topical JAK inhibitor currently under NDA review in China, an IGF-1R antibody being tested in Phase 3 studies for thyroid eye disease, and a B7-H3 antibody-drug conjugate that’s in a Phase 3 for small cell lung cancer. It’s not entirely clear when Minghui last put together a financing, though the company says on its website that it raised “over $70 million” in 2020. A spokesperson for Minghui didn’t immediately respond to a request for comment.

Instil Bio licensed ex-China rights to a bispecific antibody from China’s ImmuneOnco Biopharmaceuticals in August 2024 and secured FDA approval for a phase 1b/2 trial in the U.S. in early July.\n A PD-L1xVEGF bispecific antibody from China’s ImmuneOnco Biopharmaceuticals has shown early promise in shrinking lung tumors, instilling hope that the asset can succeed in a newly approved U.S. trial.In a phase 2 trial conducted in China, tumors diminished in 62% of patients with advanced non-small cell lung cancer (NSCLC) given IMM2510 in combination with chemotherapy, including eight of 10 with squamous NSCLC and five of 11 with non-squamous NSCLC, ImmuneOnco announced in a July 31 release.One patient discontinued IMM2510 due to a treatment-related adverse event, the biotech said, but otherwise there were no dose reductions or deaths. Most of the grade 3 or higher adverse events were blood-related, with immune events and typical VEGF side effects like hypertension, proteinuria and hemoptysis uncommon and mostly low in severity.“We are delighted to witness the progress of IMM2510 in front-line NSCLC,” ImmuneOnco CEO Wenzhi Tian, M.D., said in the release. “This data paves the way for its advancement into phase 3 clinical studies and provides valuable insights to support further research across multiple indications.”The top-line data follow the FDA’s approval of ImmuneOnco partner Instil Bio’s phase 1b/2 trial of IMM2510 in the U.S. Instil licensed ex-China rights to the bispecific in August 2024. Studying the cancer candidate in a global population “will be a critical milestone in the clinical development of IMM2510,” Instil Chief Medical Officer Jamie Freedman, M.D., Ph.D., said in a July 2 release announcing the FDA’s go-ahead.The lack of data from outside of China was an albatross around the neck of ivonescimab, Akeso and Summit Therapeutics’ Keytruda-defeating PD-1xVEGF bispecific, until recently. Ivonescimab impressed analysts in May in its first global trial, reducing the risk of progression or death by 48% in patients with previously treated EGFR-mutated non-squamous NSCLC.Ivonescimab, which is approved in China, first beat Merck’s Keytruda at improving progression-free survival in NSCLC in September 2024 in a phase 3 trial in China.Since Akeso and Summit’s success, the PD-1xVEGF arena has rapidly filled with competitors. BioNTech went out and secured the full rights to its own bispecific just months after ivonescimab’s victory over Keytruda, with the asset later scoring a win in a phase 2 trial in China.Merck itself has bought into the bispecific hype, licensing an asset from LaNova Medicines for $588 million upfront last November, while Bristol Myers Squibb decided to just go halfsies on BioNTech’s bispecific for a whopping $1.5 billion upfront.Pfizer then joined in on the fun in May of this year, paying 3SBio $1.25 billion upfront for ex-China rights to a clinical PD-1xVEGF candidate. And fellow pharma giants Eli Lilly and Novartis are keeping a close eye on the field, too.