BioNTech (BNTX) Novel Novel Data at WCLC Serves as Early Validation

Equity Research 15 September 2026 | 6:31AM EDT

BioNTech (BNTX): Novel-Novel Data at WCLC Serves as Early Validation

On the heels of presenting impressive updated gotistobart OS data, overnight at the Asad Haider, CFA | World Conference on Lung Cancer, BNTX presented data for its novel-novel Goldman Sachs & Co. LLC

combination of pumitamig (PDL1xVEGF, partnered with BMY) plus Elfe-D (B7H3 Nick Jennings | ADC) in Small Cell Lung Cancer (the topline data had also been selected for special Goldman Sachs & Co. LLC release and highlighted in a press briefing). The novel-novel combination showed 70.4% overall response rate across doses, with 92.3% in first-line SCLC, 77.3% in Jeff Su | Goldman Sachs & Co. LLC second-line disease and 52.4% in patients treated in the third line or later. Among patients previously treated with DLL3-targeting agents, the objective response rate was 70.0%.

The company views this data as adding to their conviction that novel-novel combinations can add efficacy while not adding overlapping toxicities (the safety dataset contains 279 patients), and consider it as validating to their oncology strategy. Acknowledging the caveats of cross trial comparisons, for pumitamig + chemo in 1L SCLC, BNTX published an ORR of 76.4% (n=43) at WCLC last year and for elfe-d monotherapy in 2L+ SCLC BNTX published an ORR of 56.2% (n=73) at ESMO Asia in 2024 (no data in 1L SCLC published yet for elfe-d). On the forward for this novel-novel combination, incremental updates will be presented at ESMO (October), and PFS and OS data will be key, although the company has not yet guided to when this might be available.

As previewed in BNTX: Assessing Key Events Into Year-End, on the forward, focus now moves to 1) Ph3 interim PFS analysis for BNT113, the company’s off-the-shelf mRNA cancer immunotherapy for HPV16+ head & neck cancer, expected this year, and 2) for gotistobart, the key event remains stage-2 of PRESERVE-003 towards the end of 2026. Externally, we see meaningful read-across from SMMT/Akeso’s ivonescimab, with the key remaining event the final PFS plus interim OS from the squamous cohort of the global frontline HARMONi-3 chemo-combination study due in 2H.

Valuation: Our 12-month price target of $127 derives from our DCF-based analysis with a WACC of 11% and a TGR of 1%.

Downside risks: (1) Clinical development – data for lead asset BNT327, which underpins our growth forecasts, fails to deliver clinical trial results in terms of

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efficacy, safety or combinability – that fail to result in further advancement, expansion into additional trials, or approval and commercialization as an oncology product; (2) Competitive risks – BNT327’s profile is considered materially inferior to that of competitor Summit Therapeutics (SMMT) ivonescimab; (3) Additional oncology pipeline assets fail to progress beyond clinical development, limiting the company’s capacity to achieve its objective of growth and potential leadership as a commercial oncology company; (4) COVID-19 vaccine related – worse-than-expected performance based on lower uptake, competitive share loss, failure to develop combination vaccines, or IP-related litigation; (5) capital allocation – failure to allocate capital towards attractive internal and/or external investments that leverage the company’s research capabilities.

BNTX 12m Price Target: $127.00 Price: $98.86 Upside: 28.5%

Buy GS Forecast 12/25 12/26E 12/27E 12/28E Market cap: $25.0bn Revenue (€ mn) 2,869.9 1,827.9 1,663.0 2,807.0 Enterprise value: $12.4bn EBITDA (€ mn) (1,022.1) (1,290.7) (1, m ADTV: $116.1mn EBIT (€ mn) (1,404.9) (1,772.8) (1,839.1) (633.3) Germany EPS (€) ( ) Americas…