Robert Burns

Representing Robert Burns, Dan asked about frozen cell stability testing and the approximate freezer shelf life of Allogene's products, in light of the manufacturing rollback.

Answer

CEO David Chang explained that the frozen cell products have a long stability profile, typically several years. He confirmed that stability is established through ongoing testing and expressed confidence that the current inventory is sufficient to supply all planned clinical trials.

Robert Burns of H.C. Wainwright asked how the potential earlier-line use of Amgen's tarlatamab might impact the efficacy of ZW209 in later-line SCLC. He also inquired about the PTK7-targeted ADC, asking to clarify the comparator used in preclinical studies and the view on a competitor from Whitehawk Therapeutics.

Answer

CEO Kenneth Galbraith stated that tarlatamab's success validates the T-cell engager approach in SCLC, and Zymeworks aims for ZW209 to be a next-generation molecule with enhanced efficacy and durability. Regarding PTK7, he clarified the preclinical comparator was codrituzumab, a prior clinical benchmark, and the goal was to demonstrate the superiority of their bi-paratopic format, which leverages learnings from zanidatamab and consistently outperformed mono-paratopic antibodies.

Robert Burns of H.C. Wainwright inquired about the market dynamics of DANYELZA sales following the FDA approval of DFMO and asked for an explanation for the significantly higher Cost of Goods Sold (COGS) in the quarter.

Answer

CEO Michael Rossi explained that while a new inhibitor like DFMO creates a temporary headwind as patients try new options, those who advance on the inhibitor will likely need to return to an anti-GD2 therapy like DANYELZA. Regarding COGS, Rossi noted that costs fluctuate due to the timing of batch manufacturing for a low-volume, high-value product. CFO Peter Pfreundschuh added that strong ex-U.S. sales, which include partner stock-ins, and a minor inventory write-off contributed to the higher COGS in Q4.

Robert Burns of H.C. Wainwright asked for Cardiff Oncology's perspective on the competitive threat from KRAS G12C inhibitors and emerging pan-RAS agents in the colorectal cancer treatment landscape.

Answer

Executive Mark Erlander clarified that G12C inhibitors are approved in the second-line setting for a small (4%) subset of RAS-mutated patients and do not significantly impact Cardiff's first-line focus. Regarding pan-RAS agents, he noted that their most promising signals have been in other cancers (NSCLC, PDAC) rather than colorectal cancer, but the company continues to monitor their progress.