Another Week in the Life of a CEO of a Public Biotech Company

Positive data from a randomized controlled phase 2a clinical trial of CAN-2409 in borderline resectable pancreatic cancer – you see the data, what happens next?

Eight days ago, on a Friday afternoon, my team and I saw the final overall survival data from our randomized controlled clinical trial of CAN-2409 in borderline resectable pancreatic cancer for the first time. The results were remarkable.

We did not expect that two patients with metastatic disease and residual tumor at surgery would still be alive 73.5 and 68.8 months after diagnosis. A third patient in the active group was still alive 41.3 months after diagnosis. In total, 43% of the patients in the active group remained alive after long-term follow-up—an outstanding result in this patient population.

In contrast, only one patient in the control group, who received optimal standard of care, remained alive at the data cut-off (65.5 months from diagnosis). Notably, this was a patient with a more favorable prognosis at surgical resection (absence of invasive adenocarcinoma).

While this study was randomized and controlled, it was open label, as we considered it not ethical to inject placebo into patients' tumors in this indication. Importantly, we do not reach out to trial centers for survival data outside of planned readouts. So, like everyone else, we saw these results for the first time eight days ago, as planned.

Turning Data into Action

By Monday, we had already made a critical decision: to commit to designing a late-stage clinical trial in this indication. What does that mean in practice?

? Recruiting key personnel while staying lean ? Developing a study protocol ? Pressure-testing the protocol with external experts (our Scientific Advisory Board) ? Refining the protocol and taking it through internal governance (Candel’s Science and Investment Board, including members of our high-profile Research Advisory Board) ? Engaging with the FDA to lay the groundwork for trial initiation

This means we are committing to being ready to press the start button on the trial when the time is right. This process takes time but not a lot of money—and it will inform the size and scope of the clinical trial. Conceivably, this could be a phase 2b trial in the same population that might potentially serve as a registrational study. Disciplined planning now can save significant time and money later.

Sharing the Data & Looking Ahead

By Tuesday, we released the data. Given the significance of the findings, we considered this material information. We are excited about what this could mean for patients and for the future of CAN-2409.

This next step—preparing for a late-stage trial—could create significant value for Candel and potentially position us as an attractive strategic partner.

As someone who has treated patients for decades and personally witnessed the devastating impact of pancreatic cancer, I am driven by the hope that our work can make a meaningful difference.

The Bigger Picture: Strategic Cnhoices for the Future

Beyond pancreatic cancer, Candel Therapeutics has been making strong progress across multiple indications:

?? We recently achieved the primary endpoint in our large, randomized, placebo-controlled phase 3 clinical trial of CAN-2409 in localized prostate cancer, where we have curative intent. ?? We are awaiting data from our clinical trial of CAN-2409 in non-small cell lung cancer (NSCLC) in patients who have failed standard-of-care immune checkpoint inhibitor treatment. ?? We are advancing CAN-3110, our second investigational medicine, which has demonstrated promising results—recently published in Nature.

This brings us to the key strategic question: What is the best business path forward?

?? A buyout soon for X B$? ?? A buyout later, when we have an approved medicine in prostate cancer and ongoing late-stage trials in pancreatic cancer and NSCLC—potentially for 15–20X B$? ?? Going all the way ourselves, partnering with the best commercial teams without building a massive, fixed infrastructure? ?? A hybrid approach?

It was another incredible week at Candel Therapeutics—one filled with both scientific breakthroughs and strategic decision-making. I’m excited for what lies ahead.

What would you do? I’d love to hear your thoughts.

#Biotech #Oncology #Leadership #ClinicalTrials #PancreaticCancer #CandelTherapeutics $CADL

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