On November 4, 2022 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported that it will present four abstracts and host an in-person Research & Development Day, Friday, November 11, 2022, at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting which will be held November 8 – 12, 2022 at the Boston Convention and Exhibition Center in Boston, MA (Press release, Molecular Templates, NOV 4, 2022, View Source [SID1234623140]).

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The R&D Day event will include in-person presentations by the senior leadership team of Molecular Templates reviewing the technology of next-generation ETBs, the clinical highlights informing development strategies, and the data presented at SITC (Free SITC Whitepaper) around its PD-L1 targeting MT-6402 and CTLA-4 targeting MT-8421 programs. The event will be webcasted and take place 11:30am – 12:30pm ET Friday, November 11, 2022, at the Boston Convention Center during SITC (Free SITC Whitepaper)’s 37th Annual Meeting. A live Q&A session will follow the presentation.

Four abstracts to be presented at SITC (Free SITC Whitepaper) include:
"We look forward to updating the community on data presented at SITC (Free SITC Whitepaper). We believe the approach MTEM has taken in immuno-oncology is highly differentiated and that we are seeing early signs this approach can provide patient benefit and open up new avenues for targeting PD-L1 and CTLA-4," said Eric Poma, Chief Executive Officer of Molecular Templates.

On November 4, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Tuesday, November 15, 2022 at 5:00 p.m. (EST) to discuss corporate developments and financial results for the third quarter ended September 30, 2022 (Press release, Navidea Biopharmaceuticals, NOV 4, 2022, View Source [SID1234623139]).

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Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

View Source

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On November 4, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will release third quarter 2022 results and corporate update on Tuesday, November 15, 2022 (Press release, Affimed, NOV 4, 2022, View Source [SID1234623138]). The Company will host a conference call at 8:30 a.m. EST / 14:30 CET.

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The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source
To access the call by phone, please use link: https://register.vevent.com/register/BI62ec6e16028b424eba578af8c49e4240, and you will be provided with dial-in details and a pin number.

On November 4, 2022 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported that it will present survival data from the phase 3 VITAL study at an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Conference 2022 (ASH) (Free ASH Whitepaper) (Press release, Prothera, NOV 4, 2022, View Source [SID1234623135]). The meeting will be held December 10-13, 2022 in New Orleans, LA.

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Phase 3 VITAL study data on observed survival benefit in Mayo Stage IV AL amyloidosis patients treated with birtamimab was consistent after adjusting for baseline variables. The observed survival benefit adds to the totality of existing data supporting birtamimab in this patient population. Prothena has advanced birtamimab into the confirmatory Phase 3 AFFIRM-AL study in patients with Mayo Stage IV AL amyloidosis under a Special Protocol Assessment (SPA) with the FDA with a primary endpoint of all-cause mortality at p≤0.10.

Following are details of the VITAL oral presentation at ASH (Free ASH Whitepaper):

Oral Presentation #760: Survival Benefit of Birtamimab in Mayo Stage IV AL Amyloidosis in the Phase 3 VITAL Study Consistent after Adjustment for Key Baseline Variables
Presenting Author: Morie Gertz, MD
Session Date: December 12, 2022
Presentation Time: 11:15 AM ET
About Birtamimab

Birtamimab is an investigational monoclonal antibody designed to specifically and selectively target and clear the amyloid that accumulates and causes organ dysfunction and failure in patients with AL amyloidosis. Birtamimab is the only investigational therapeutic that has shown a significant survival benefit in patients with Mayo Stage IV AL amyloidosis in a placebo-controlled study. Birtamimab has been granted orphan drug designation for AL Amyloidosis by both the U.S. FDA and the European Medicines Agency and has been granted Fast Track designation by the FDA. A SPA was agreed to between Prothena and the FDA for the AFFIRM-AL trial which represents FDA’s agreement that the design and planned analysis for the primary endpoint of time to all-cause mortality adequately address the objectives necessary to support a regulatory submission. Results from the AFFIRM-AL trial are anticipated in 2024. Final marketing approval is predicated upon FDA’s complete review of the entire application.

About Confirmatory Phase 3 AFFIRM-AL Trial

The AFFIRM-AL study is a global, multi-center, double-blind, placebo-controlled, 2:1 randomized, time-to-event trial expected to enroll approximately 150 newly diagnosed, treatment naïve patients with AL amyloidosis categorized as Mayo Stage IV. The trial is being conducted under a SPA agreement with FDA and supported by the significant survival benefit observed in the previous analysis of birtamimab-treated patients categorized as Mayo Stage IV at baseline in the VITAL study. For more information on the clinical trial please visit View Source

About AL Amyloidosis

AL amyloidosis is a rare, progressive and fatal disease where clonal plasma cells overproduce light chain proteins that misfold, aggregate and deposit as amyloid in vital organs such as the heart. It is estimated that there are 60,000 – 120,000 patients worldwide living with Mayo Stage IV AL amyloidosis. Patients with AL amyloidosis can present with a wide range of general symptoms that are common to other conditions such as fatigue, shortness of breath or edema. Current treatment strategies target plasma cells to reduce production of new amyloid, but do not address the amyloid already deposited in organs. Mortality is driven primarily by cardiac failure. There is an urgent unmet medical need for therapies that improve survival in patients at risk for early mortality due to amyloid deposition.

On November 4, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, will announce third quarter 2022 financial results on Wednesday, November 9, 2022 (Press release, Cyclacel, NOV 4, 2022, View Source [SID1234623134]). The company will host a conference call and live webcast at 4:30 p.m. Eastern Time on the same day.

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For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.