To make things easier, I have created a bullet-point list of major and salient reasons as to why Sesen Bio $SESN is deeply undervalued and should yield investors significant return in the coming days. I am using recently gathered evidence, including recent conference call, as support for this write-up.
- Positive Phase 3 "Vista" Trial - CEO, Thomas Cannel, stated "bladder cancer is an area of significant unmet need and we are seeing strong support for new treatments from regulators, payers, patients and physicians."
- Vicinium selectively targets cancer cells while generally avoiding healthy cells, which we believe ties to its favorable safety profile.
- "Believe[s] Vicinium has a unique dual mechanism of action, which made physician it as a preferred choice for combination therapy with checkpoint inhibitors."
- "We estimate that the median number of cystectomy-free days for all patients in the VISTA trial is 519 days or approximately 18 months, based on current trends of preliminary data."
- Radical cystectomy is second-line with a significant impact on mortality, morbidity and quality of life. And because of this, stakeholders are extremely supportive of any new therapy that could be used in lieu of radical cystectomy.
- "In a recent teleconference with the FDA, they requested that we come in for a pre-BLA Meeting in mid-2019. We will be scheduling that meeting and look forward to future discussions with the agency."
- The company will have more information when it presents the updated 12-month data set mid-2019, but we are certainly pleased with the durable anti-tumor activity that was reflected in these preliminary data.
- The company hase had some investigators say that Vicinium is so well tolerated that their patients sometimes ask whether they are even on treatment
- The National Cancer Institute is assessing the combination of Vicinium and Durvalumab, which is an anti-PD-L1 checkpoint inhibitor. In the future, the company thinks "it could be significant to be positioned as the preferred choice for combination therapy with checkpoint inhibitors and that combination could be a valuable alternative for patients who do not achieve the complete response on either BCG or Vicinium."
- "Conducted 11 in-depth interviews with high-prescribing urologists and key opinion leaders to get their view on our most recent clinical data. These interviews went one to three hours and we were very pleased with the results."
"We [Sesen Bio] have been talking to potential partners from outside the U.S. While the U.S. accounts for about 20% of the total global market opportunity, Europe, Latin America, the Middle East and Asia-Pacific, also represents sizable market opportunities. Because of this, we believe that OUS sales could outpace U.S. sales of Vicinium in the future.
Disclosure: I am/we are long SESN.