AFFIMED TO REPORT THIRD QUARTER 2022 FINANCIAL RESULTS & CORPORATE UPDATE ON NOVEMBER 15, 2022

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.

Prothena to Present Data on Survival Benefit Observed in Completed Phase 3 Study of Drug Candidate Birtamimab in Patients with Mayo Stage IV AL Amyloidosis at the ASH 2022 Meeting

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.

Cyclacel Pharmaceuticals to Release Third Quarter 2022 Financial Results

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.

REACTION BIOLOGY AND VYANT BIO ANNOUNCE CLOSING OF DEFINITIVE AGREEMENT TO ACQUIRE U.S. OPERATIONS OF VYANT BIO, INC. SUBSIDIARY

On November 4, 2022 Reaction Biology Corporation ("Reaction"), an industry-leading provider of drug discovery services, and Vyant Bio, Inc. ("Vyant Bio") (Nasdaq: VYNT), an innovative biotechnology company reinventing drug discovery for complex neurodevelopmental and neurodegenerative disorders, reported that the companies have closed on a definitive agreement for Reaction to acquire Vyant Bio’s subsidiary vivoPharm LLC, located in Hershey, Pennsylvania (Press release, Vyant Bio, NOV 4, 2022, View Source [SID1234623132]).

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Reaction will retain U.S. personnel from the acquired operations to establish its Hershey, Pennsylvania presence, which includes in vitro and in vivo capabilities. Through the acquisition, Reaction gains laboratory facilities, equipment, employees, cell lines and capabilities (in pharmacology, toxicology, pathology and bio analytics) that further expand the industry-leading suite of drug discovery services that Reaction provides for its biopharmaceutical customers. The purchase price for this transaction is $5.5 million in an upfront cash payment, subject to customary adjustments for working capital, closing cash, indebtedness and transaction expenses. After these closing adjustments were reflected, $5.5 million was paid at closing. Vyant Bio expects to net approximately $4.4 million in cash after tax and transaction related expenses, as well as incur $0.6 million in exit costs associated with this transaction.

"vivoPharm’s U.S. operations are highly complementary to Reaction’s existing suite of drug discovery CRO services, enabling us to build upon our legacy of excellent science and customer-centric innovation," said John H. Johnson, Chief Executive Officer of Reaction Biology. "This investment in talent, infrastructure and resources is an important step in our roadmap for fully realizing Reaction’s potential as a provider of solutions for discovery and development of new drug candidates."

"This transaction provides non-dilutive capital and enables Vyant Bio to further concentrate our efforts to more rapidly advance our therapeutic pipeline in genetic CNS disorders," said Jay Roberts, President and Chief Executive Office of Vyant Bio. "Reaction is an ideal partner to leverage vivoPharm’s preclinical oncology and immuno-oncology drug discovery services, including one of the broadest collections of syngeneic tumor models, well-characterized tumor cell lines and highly qualified technicians using our state-of-the art laboratories."

White & Case LLP served as Reaction’s legal counsel. Lowenstein Sandler LLP served as Vyant Bio’s legal counsel. Colliers Securities LLC and Lake Street Capital Markets LLC acted as financial advisors to Vyant Bio in the transaction.

OMEROS CORPORATION ANNOUNCES UPCOMING PRESENTATIONS AT ASH ANNUAL MEETING

On November 4, 2022 Omeros Corporation (Nasdaq: OMER) reported that two presentations pertaining to Omeros’ investigational complement inhibitors will be featured at the upcoming 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held from December 10-13, 2022 in New Orleans (Press release, Omeros, NOV 4, 2022, View Source [SID1234623130]). The following abstracts were published today and are now available on the ASH (Free ASH Whitepaper) website at www.hematology.org:

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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Alternative Pathway MASP-3 Inhibitor OMS906 in a Phase 1 Study of Healthy Subjects (Abstract #2570)
Session Name: 508. Bone Marrow Failure: Acquired: Poster II
Date: Sunday, December 11, 2022
Presentation Time: 6:00 p.m. – 8:00 p.m. ET
Location: Ernest N. Morial Convention Center, Hall D

Trial in Progress: An Open-Label, Multi-Center Phase 2 Study Evaluating Efficacy and Safety of the MASP-2 Inhibitor Narsoplimab in Pediatric Patients with High-Risk Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (HSCT-TMA) (Abstract #3808)
Session Name: 331. Thrombotic Microangiopathies/Thrombocytopenias and COVID-19-related Thrombotic/Vascular Disorders: Clinical and Epidemiological: Poster III
Date: Monday, December 12, 2022
Presentation Time: 6:00 p.m. – 8:00 p.m. ET
Location: Ernest N. Morial Convention Center, Hall D

Following presentation at the meeting, the posters will be available on Omeros’ website at www.omeros.com