SESEN BIO Forum: Community User: fb19077

An Spannung Fehlers mir gerade nicht bei sesen

Bei 1€ eingestiegen🙌🏽 ab 4.Dezember wird es spannend!

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 12, 2019-- Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported financial results for the third quarter of 2019 and provided an update on regulatory activities related to Vicinium. “The third quarter of 2019 marked a pivotal period for the Company, as we began preparations to transition from a development stage to a commercial stage organization,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “We believe Vicinium has demonstrated compelling and clinically meaningful efficacy, and we look forward to submitting these data to the FDA as part of the initiation of our BLA submission in December. This key value inflection point sets up 2020 to be a transformational year for us and we are excited to continue working expeditiously to potentially bring Vicinium to market to help save and improve the lives of patients with NMIBC.” Vicinium Regulatory Pathway Update Recent positive interactions with the FDA support the Company’s confidence in the regulatory and commercial pathway for Vicinium On November 4, 2019, the Company met with the FDA for a Type C meeting to discuss the details of a post-marketing confirmatory trial for Vicinium. The Company reached agreement with the FDA that the trial will enroll BCG-refractory patients who have received less-than-adequate BCG. This represents a broader patient population than the BCG-intolerant population originally proposed and it is anticipated that, if Vicinium is approved by the FDA and the post-marketing confirmatory trial is successful, labeling will be expanded to include this additional patient population. This trial is expected to be powered to demonstrate the superior efficacy of Vicinium compared to currently utilized therapies for the primary endpoints, which are expected to include the complete response rate and duration of response in CIS patients. These data, along with the secondary endpoints, which are expected to include a number of quality of life, survival and safety endpoints, are anticipated to position Vicinium for favorable reimbursement with payers. Key Fourth Quarter 2019 Events FDA meeting on December 4, 2019 to discuss the submission strategy for CMC Module 3 Anticipated initiation of BLA submission under a Rolling Review in December 2019 Sesen Bio Regulatory Update in December 2019 Third Quarter 2019 Financial Results Cash Position: Cash and cash equivalents were $57.9 million as of September 30, 2019, compared to $50.4 million as of December 31, 2018. R&D Expenses: Research and development expenses for the third quarter of 2019 were $6.6 million compared to $3.4 million for the same period in 2018. The increase of $3.2 million was due primarily to costs related to the ongoing technology transfer process as we scale-up for commercial manufacturing and increased regulatory, internal and external staffing costs, partially offset by reduced expenses related to the Phase 3 VISTA trial. G&A Expenses: General and administrative expenses for the third quarter of 2019 were $3.2 million compared to $3.8 million for the same period in 2018. The decrease was due primarily to lower legal, commercial and internal employee staffing costs, offset by higher professional fees. Net Loss: Net loss was $13.1 million, or $0.13 per share, for the third quarter of 2019, compared to $14.0 million, or $0.18 per share, for the third quarter of 2018. The decrease was due primarily to a lesser non-cash change in the fair value of contingent consideration, offset by the higher research and development expenses described above. About the VISTA Clinical Trial The VISTA trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicinium® as a monotherapy in patients with high-risk, bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC). The primary endpoints of the trial are the complete response rate and the duration of response in patients with carcinoma in situ with or without papillary disease. Patients in the trial received locally administered Vicinium twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years. To learn more about the Phase 3 VISTA trial, please visit www.clinicaltrials.gov and search the identifier NCT02449239. About Vicinium® Vicinium, a locally-administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicinium promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

https://www.sec.gov/Archives/edgar/data/1485003/000148500319000086/exhibit991sesn3qbusiness.htm

Die Frage ist jetzt bleibt es beim 12.11. für weitere infos oder schieben die das auf Dezember weil da ja auch ein Regulatory Update kommen soll.

Sehr gute Neuigkeiten 👍

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 5, 2019-- Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported alignment with the FDA on the design of its post-marketing confirmatory trial for Vicinium. Sesen Bio reached agreement with the FDA that the post-marketing confirmatory trial for Vicinium will enroll BCG-refractory patients who have received less-than-adequate BCG*, which is especially important in light of the ongoing BCG shortage. This represents a broader patient population than the originally proposed BCG-intolerant population. It is anticipated that, if Vicinium is approved by the FDA, the initial indication will be for BCG-unresponsive patients who have received adequate BCG. However, assuming the post-marketing confirmatory trial is successful, it is expected that labeling will be expanded to include this additional population of patients who have received less-than-adequate BCG. “This was our third face-to-face meeting with the FDA in the past 6 months, and we continue to have very positive and constructive interactions, which help us advance Vicinium toward regulatory review and approval,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “Our long-term relationship with the Agency has allowed us to shape our clinical program in alignment with FDA guidance. It has also helped to ensure that we are able to address the broadest possible segment of appropriate patients, and is expected to provide payers with the superiority data that will help to ensure product reimbursement. We look forward to our next FDA meeting in December.” The trial is expected to be powered to demonstrate the superior efficacy of Vicinium compared to currently utilized therapies for the primary endpoints, which are expected to include the complete response (CR) rate and duration of response in CIS patients. Secondary endpoints are expected to include a number of quality of life, survival and safety endpoints, with the objective of demonstrating the superiority of Vicinium relative to currently utilized therapies. In addition, after a discussion of favorable Phase 3 post-hoc analyses with the FDA, the trial is expected to be designed to detect a delayed CR in patients who were non-CRs at the initial 3-month assessment. Key Fourth Quarter 2019 Events FDA meeting on December 4, 2019 to discuss the submission strategy for CMC Module 3 Anticipated initiation of BLA submission under a Rolling Review in December 2019 Sesen Bio Regulatory Update in December 2019 * As per the 2018 FDA guidance on NMIBC, adequate BCG is defined as at least 5 doses in an initial induction course, plus at least 2 doses in a second course.

Geschaft

Das sind wir morgen schon

Schwach ist das sie sich erst am 12. äußern wollen,bis dahin können wir unter dem $ sein...

Die Frage ist, wie Hoch ist der neue Preis für die Ausübung der Optionsscheine!!!

Das Risiko von Penny's.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 29, 2019-- Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported modifications to its 2017 and 2018 common stock warrants, which enhance the Company’s capital raising optionality by allowing for future at-the-market (ATM) programs. “Today we took an important step to enhance our capital structure, giving us the tools to potentially build upon our financial position with a number of upcoming value-inflection points over the next year,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “This was an important strategic decision to position the Company with the greatest optionality as we prepare for upcoming FDA engagements, our planned BLA submission and a potential future approval of Vicinium for patients with non-muscle invasive bladder cancer. The remainder of 2019 will be a critical period for Sesen Bio, and we look forward to continued progress across the organization.” Key Fourth Quarter 2019 Events FDA meeting on November 4, 2019 to discuss the post-marketing confirmatory trial for Vicinium FDA meeting on December 4, 2019 to discuss the submission strategy for CMC Module 3 Anticipated initiation of BLA submission under a Rolling Review in December 2019 The Company will provide more information at a Business Update on November 12, 2019 at 8:00 a.m. EST. To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 1377227. The webcast can be accessed in the Investor Relations section of the Company’s website at www.sesenbio.com. The replay of the webcast will be available in the Investor Relations section of the Company’s website at www.sesenbio.com for 60 days following the call.

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