Lots of upside room ...Just to show how undervalued we are and what the upside room can be, SESEN, that was turned down twice by the FDA approval for the same indication as ours (NMIBC BCG-unresponsive) and that is required by the FDA to do a Ph. 3, is currently valued at 116MM$US (TLT is now worth 68MM$US). So we are 50% below their valuation, despite all their problems!
Before the first August 2021 FDA decision, SESEN was being valued at around 800MM$US-1B$US at its peak (such valuation is again in line with the usual low-range valuation of a drug that is seen as a candidate to a FDA approval).
Sesen Bio (SESN) - Market capitalization For TLT to reach similar 800MM$US-1B$US valuation, that would bring us to 3.90$US-4.90$US per share (so 4.95$CAN-6.25$CAN).
Now, lets just take 50% of that value. That would give us a 2.45$CAN-3.10$CAN per share. So 5.80-7.4x our curent valuation.
Now, lets just take 33% of that value. That would give us a 1.65$CAN-2.10$CAN per share. So 4-5x our curent valuation.
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August 13, 2021 -
Sesen Bio Receives Complete Response Letter from FDA for Vicineum Aug. 13, 2021-- Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Vicineum™ (oportuzumab monatox-qqrs) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
The FDA has determined that it cannot approve the BLA for Vicineum in its present form and has provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls (CMC) issues pertaining to a recent pre-approval inspection and product quality.
Oct. 2021 -
Sesen Bio shares crater after report of trial misconduct for bladder cancer drug a bombshell report from Stat, based on unreleased internal documents the media outlet obtained, suggested that the rejection should not have come as a surprise.
Stat reported that Vicineum treatment had led to dangerous elevations in liver enzymes for some patients—a development that the company had not disclosed. The study underpinning the FDA filing had more than 2,000 trial protocol violations—215 of them major. And three trial investigators were reported to the FDA for serious misconduct, the news outlet reported.
The story also said that a patient died from liver failure in 2016 and that Sesen did not disclose the incident at a medical conference two years later.
May 9, 2022 - SESEN Business update
During the quarter, the Company continued to engage with the US Food and Drug Administration (FDA) to identify an anticipated regulatory path toward potential resubmission of a Biologics License Application (BLA) for Vicineum™ for the treatment of non-muscle invasive bladder cancer (NMIBC). The Company has also initiated a process to review strategic alternatives with the goal of maximizing shareholder value.
US Regulatory Update
- On March 28, 2022, Sesen Bio participated in a Type C Meeting with the FDA. During the meeting, the FDA agreed to a majority of the Company’s proposed protocol and statistical analysis plan design elements for an additional Phase 3 clinical trial that it plans to conduct for potential resubmission of a BLA for Vicineum for the treatment of NMIBC. The Company plans to meet with the FDA in mid-2022 to align on the remaining outstanding items related to the additional Phase 3 clinical trial, and intends to request that meeting in the coming weeks.
In addition to working with the FDA to align on a study design, the Company has been addressing comments related to Chemistry, Manufacturing and Controls (CMC) that were included in the Complete Response Letter (CRL) for the BLA for Vicineum for the treatment of bacillus Calmette-Gurin (BCG)-unresponsive NMIBC. The Company has completed technical work on several of the key CMC comments and is continuing to make progress on the remaining items. The Company’s responses to the CMC comments will ultimately be reviewed by the FDA upon a potential BLA resubmission.
Other Business Updates
- On January 6, 2022, Sesen Bio disclosed that it achieved a $20 million milestone payment pursuant to the Company’s exclusive license agreement (Roche License Agreement) with Roche for legacy Interleukin-6 (IL-6) antagonist antibody technology owned by Sesen Bio. Following this milestone payment, Sesen Bio has cumulatively received $50 million in upfront and milestone payments, with an additional $220 million in potential future milestone payments, as well as royalty payment obligations on future sales, remaining under the Roche License Agreement. As part of the Roche License Agreement, Roche also maintains the right to fully acquire the IL-6 technology.
- On May 3, 2022, Sesen Bio announced that it had initiated a process to review strategic alternatives with the goal of maximizing shareholder value. Potential strategic alternatives to be explored and evaluated during the review process may include the sale of the Company, a merger, acquisition or other business combination, a strategic partnership with one or more parties, or the licensing, sale or divestiture of some of the Company’s proprietary technologies. The Company is actively working with an investment bank in this process. Pending any decision to undertake any strategic alternative, the Company is continuing its development activities in accordance with its existing business strategy.
- On June 22, 2022, Sesen Bio will hold its Annual Meeting of Stockholders, one of the primary purposes of which will be to approve a proposal for a reverse stock split, which includes a proportionate reduction in authorized shares of common stock. The proposed reverse stock split, if approved, should allow the Company to remain listed on the Nasdaq Global Market, which should increase the range and attractiveness of strategic alternatives that the Company is able to consider to maximize shareholder value.