BMO Capital Markets analyst Evan David Seigerman said that the PFS miss for BNT113 “adds to a growing list of recent mRNA cancer vaccine setbacks” and is likely to pressure the stock.
- Seigerman highlighted two recent discontinuations for the individualized mRNA candidate autogene cevumeran — jointly developed by BioNTech and Genentech — in bladder cancer and colorectal cancer.
- Evercore ISI called the PFS miss “disappointing, but consistent with our reading of the earlier Phase 2 data.”
- Citi pointed out that the trial design still allows a positive outcome if OS improves, “preserving a meaningful development path.”
BioNTech shares (BNTX) closed down roughly 7% on Tuesday after the company reported that its investigational mRNA cancer immunotherapy BNT113 failed to show a statistically significant progression-free survival (PFS) benefit in a key late-stage trial, a result an analyst said reflects a broader pattern of challenges for mRNA cancer vaccines.
In the Phase 2/3 AHEAD-MERIT study, BNT113—an off-the-shelf mRNA immunotherapy —was tested in combination with Merck’s drug pembrolizumab versus pembrolizumab alone as first-line treatment for certain patients with unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma.
At the first analysis of the dual primary endpoints, the combination did not show a statistically significant PFS improvement, the company said on Tuesday. The independent data monitoring committee recommended that the trial continue as planned to assess overall survival, the second primary endpoint. Under the pre-specified trial design, a significant OS benefit would still constitute a positive outcome even without a PFS win.
BNTX Analyst Reactions Highlight Reduced Confidence
BMO Capital Markets analyst Evan David Seigerman said that the PFS miss “adds to a growing list of recent mRNA cancer vaccine setbacks” and is likely to pressure the stock.
Seigerman, who maintains a Market Perform rating and $105 price target, said the miss on progression-free survival (PFS)—the length of time patients lived without their cancer getting worse—for BNT113 plus pembrolizumab in the AHEAD-MERIT study leaves open the possibility of a later overall survival (OS) benefit, meaning patients living longer overall, but with significantly reduced confidence.
He highlighted two recent discontinuations for the individualized mRNA candidate autogene cevumeran — jointly developed by BioNTech and Genentech — in bladder cancer and colorectal cancer. While an OS improvement is still possible, BMO views it as less likely given today’s miss.
Evercore ISI and Citi called the PFS miss disappointing. Evercore, which rates the shares ‘Outperform’ with a $130 target, said BioNTech’s valuation is tied more closely to the outlook for its pumitamig program and rival Summit Therapeutics’ upcoming readout for its experimental drug ivonescimab in first-line metastatic non-small-cell lung cancer than to this single result.
Citi kept a ‘Buy’ rating and $125 target, and pointed out that the trial design still allows a positive outcome if OS improves, “preserving a meaningful development path.”
BioNTech’s Optimistic Stance
BioNTech Chief Medical Officer Özlem Türeci stated on Tuesday that while the PFS result was not statistically significant, the data support continued evaluation and indicate the candidate is engaging its intended mechanism. She emphasized that immune-mediated anti-tumor effects can build over time, making the OS analysis critical for assessing durable benefit in this HPV-driven disease, for which no approved HPV-targeted therapies currently exist.
Investors will now watch for OS data from AHEAD-MERIT, expected later, as the company continues to position mRNA immunotherapies as a core pillar of its oncology strategy amid the transition away from COVID-19 vaccine revenues.
How Did BNTX Retail Traders React?
On Stocktwits, retail sentiment around BNTX stock jumped from neutral to bullish territory over the past 24 hours, while message volume stayed at normal levels.
A Stocktwits user opined that the stock will slip further, noting that the company’s CEO Uğur Şahin, as well as CMO Özlem Türeci, who also co-founded the company, are slated to step down by the end of the year, leaving the company without fresh leadership for a while.
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Another user opined that the trial outcome was expected given the difficulty of treating late-stage cancer and voiced optimism for the company’s other oncology assets.
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BNTX stock has fallen by about 7% year-to-date.
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