Industry watchers are still awaiting detailed data or readouts from three ivonescimab phase 3 trials.
Summit Therapeutics, which has consistently been communicating quarterly results through investor calls in the past few years, has suddenly decided to go without one.The lack of an earnings call accompanying Summit’s second-quarter results came after Bloomberg last month reported that the company was engaged in high-stakes licensing talks for its PD-1xVEGF antibody ivonescimab.“Coincidence? We don’t think so, as we’re unsure how else to explain the radio silence,” Evercore ISI analysts wrote in a Monday note.“The silence is deafening,” the analysts continued, noting that Summit’s second-quarter press release lacks new information but serves mostly as a recount of past events without any comments from the management team.Companies may opt not to hold conference calls if they are in the process of a major, market-moving development to avoid making any statements that could impact their discussions or violate confidentiality agreements.Last month, Bloomberg reported that Summit was in discussions with AstraZeneca for a potential deal worth $15 billion. The biotech had also talked to other large pharma companies, according to Bloomberg, citing people familiar with the matter.“We continue to believe it is critical that Summit secure a partnership that will support VEGFA/PD-1 ivonescimab’s global development,” Leerink Partners analysts said in a note this week, arguing that the company lacks the means to rapidly advance the drug in combination regimens by itself. On Monday, Summit proposed to raise up to $360 million by selling new shares of its stock from time to time. As of the end of June, Summit had cash and cash equivalents worth nearly $298 million.The new money “could provide the company with temporary alleviation of their cash overhang, but it does not preclude the need to partner [ivonescimab],” the Leerink team said. The question remains as to which pharma giant has a robust enough pipeline to pair with ivonescimab and enough firepower to pull off a deal. Summit, which currently revolves solely around ivonescimab, has a market cap of above $20 billion.Pfizer recently shelled out $1.25 billion upfront—and committed up to $4.8 billion in milestones—for 3SBio’s PD-1xVEGF candidate, coded SSGJ-707. Then Bristol Myers Squibb agreed to pay BioNTech $3.5 billion upfront, with up to $7.6 billion in potential milestones, to co-develop and co-commercialize a PD-L1xVEGF drug that the German company had acquired from Biotheus. During a recent investor event, Pfizer’s newly minted Chief Oncology Officer, Jeff Legos, Ph.D., touted the New York pharma’s antibody-drug conjugates as potential combinable assets with SSGJ-707.“Part of this development plan will be to look at the inter-portfolio combination opportunities, particularly with some of our ADCs where we’ve been generating evidence that combinations with anti-PD-1 agents can deliver potentially practice-changing results,” Legos said.Summit previously formed a clinical collaboration with Pfizer. But that partnership is dead now with Pfizer’s 3SBio deal.Meanwhile, industry watchers are still awaiting detailed data or readouts from three ivonescimab phase 3 trials.The Chinese HARMONi-6 trial, which is evaluating ivonescimab against BeOne Medicines’ PD-1 inhibitor Tevimbra in their respective combinations with chemotherapy in first-line squamous non-small cell lung cancer, recently met its primary endpoint of progression-free survival.The Leerink team sees reduced near-term implications from this study for Summit because the trial is likely too early to show overall survival outcomes.A readout from the global HARMONi trial in EGFR-mutated NSCLC recently disappointed investors. While positive on progression-free survival, the study did not meet the overall survival goal at the time of the readout. Summit did not provide a breakdown of overall survival data in Asian and North American patients but said both groups showed a positive trend.As Leerink sees it, the most important ivonescimab readout in the near term is the China-only HARMONi-2 study. The high-profile Keytruda head-to-head study has repeatedly made headlines. There, ivonescimab monotherapy has decisively beaten Merck & Co.’s Keytruda in first-line PD-L1-positive NSCLC. The entire oncology field is waiting for its overall survival readout after a premature look at the data led to divided reviews. As Summit’s stock price fluctuates, the company’s board in April shifted the goalpost of the company’s executive compensation plan. Specifically, Summit has switched the remaining stock option awards issued under its 2020 stock incentive plan from performance-based to require only continued service with the firm.The new plan was laid out in the company's annual proxy (PDF) statements filed shortly after the unplanned HARMONi-2 overall survival readout had crashed Summit's stock price. To justify the decision, the board cited “consideration of the compensation program overall” and “the achievement of the market capitalization performance condition.”As a result of the modification, half of the remaining stock options vested in the second quarter, leading to an aggregate expense of $467 million. The remaining half will vest in three annual tranches beginning in October 2025, according to the firm’s proxy filing in April.
