SESN conference call Tuesday morning on FDA BLA acceptance for Vicineum. Royalties anticipated for ENZN should (imo) enhance price support above the current .70’s. Peeps still selling in the .60’s makes no sense. A copied post from Yahoo SESN MB david graham:
Leading up to the February 16 FDA decision on BLA acceptance and PDUFA date--to summarize:
1. There is a BCG shortage worldwide for Bladder Cancer patients with few drug options in the last 30 years. Vicinium would provide options to last resort with cystectomy for BCG unresponsive patients.
2. Potential sales after FDA approval this year evaluated between $1B-$3B
3. Sesen Bio has no debt
4. All 3 drug manufacturing PPQ runs were successful before submitting the BLA on 18 Dec 2020 with a request for Priority Review.
5. Acceptance of BLA from the FDA 16 Jan 2021.
6. BLA has been under rolling review for over a year with the FDA.
7. FDA requested to perform a phase IV trial to expand upon the patient population of unresponsive to BCG (seen as a positive sign towards approval)
8. Early 2021 - submission of marketing application in Europe
9. Decision at the Committee for Medicinal Products for Human Use (CHMP) held 25-29 January 2021
recommendation on the request for accelerated assessment.
10. Antibody-drug conjugates (ADC) are well received in the medical community. A large percentage of Dr (Urologists) indicated they would prescribe it. (83%) see First-Quarter-2020-Financial-Results presentation.
11. The ICER Effectiveness and Value report was published confirming Vicineum ( Oportuzumab Monatox) benefits over other drugs.
12. Sesen Bio's CEO re-iterated the work being done to sign multiple deals outside the US (OUS) after China.
13. Sesen Bio and Qilu Pharmaceutical announced the IND application for Vicinium is accepted for review by the national medical products administration in China
14. Sesen Bio is also looking into imaging agent which would be beneficial for surgeons and patients for removal of entire cancer tissue.
15. On January 11, 2021, Sesen Bio, disclosed in an updated corporate presentation that it had cash, cash equivalents, and restricted cash of approximately $55 million as of December 31, 2020.
16. Low risk of offering in the near future as the company is using an ATM for financing with an estimated $37M remaining.
17. Awaiting results from Head and Neck study. Vicineum in combination with AstraZeneca’s anti-PD-L1, Imfinzi (durvalumab), is being evaluated in a Phase 1 study that is being run by the National Cancer Institute. ... on tweeter Andrea Apolo, M.D. posted "We have a combination trial of vicineum plus durvalumab for BCG refractory NMIBC that we are excited about at the NCIResearchCtr"
18. Longest time to cystectomy of all competitors
19. Vicineum has low toxicity numbers, adding chances of early approval from the FDA.
