On December 6, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported that the Company has received €2.5 million in non-dilutive funding (Press release, Celyad, DEC 6, 2019, View Source [SID1234552005]). The amount is comprised of €2.1 million in non-dilutive funding from the SPW-Recherche of the Walloon Region, which will support the development of the company’s CAR-T candidates for the treatment of solid tumors, and €0.4 million of non-refundable tax incentive from Belgian Public Health Insurer.

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Filippo Petti, chief executive officer of Celyad, commented, "These latest additions of non-dilutive funding awarded by the Walloon Region and the Belgian government continues to support the ongoing development of our CAR-T cell therapy platform and furthers the advancement of our hematological malignancy and solid tumor programs. We are grateful for their faithful support which amounted to a total of €11 million of non-dilutive funding in 2019 for the company. The funding also provides additional momentum for the company as we enter 2020 and drive towards our mission to develop innovative CAR-T cell therapy candidates for the treatment of cancer patients."

Under the terms of this funding from the Walloon Region of Belgium, the Company was awarded non-dilutive funding in the form of recoverable cash advances (‘avances récupérables’) for €2.1 million. The regional funding is associated with the Company’s specific research and development programs. Under the applicable conditions, the recoverable cash advance is reimbursable over the economic life of the projects. Thirty percent is refundable based on a fixed reimbursement schedule varying between 20 and 25 years, while the balance is refunded under the form of royalties over the same period.

On December 6, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the schedule of triple therapy data presentations, at the upcoming 61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting and exposition, to be held December 7 – 10, 2019, at the Orange County Convention Center in Orlando, FL (Press release, TG Therapeutics, DEC 6, 2019, View Source [SID1234552004]).

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Presentations at the ASH (Free ASH Whitepaper) 2019 meeting include the following:

Oral Presentation Details:

Title: A Phase 1/2 Study of Umbralisib Ublituximab and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Publication Number: 360
Oral Session: 642. CLL: Therapy, excluding Transplantation: Combination and Novel Treatment
Session Date and Time: Sunday, December 8, 2019; 7:30 AM – 9:00 AM ET
Presentation Time: 8:45 AM ET
Location: Orange County Convention Center, Hall E1
Presenter: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY

Poster Presentation Details:

Title: Phase 1 Study of TG-1701, a Selective Irreversible Inhibitor of Bruton’s Tyrosine Kinase (BTK), in Patients with Relapsed/Refractory B-Cell Malignancies
Publication Number: 4001
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III
Date and Time: Monday, December 9, 2019; 6:00 PM – 8:00 PM ET
Location: Orange County Convention Center, Hall B
Presenter: Chan Cheah, MD, Sir Charles Gairdner Hospital, Hollywood Private Hospital, University of Western Australia, Blood Cancer Research Western Australia

On December 6, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO), reported that the company will host a webcast on Tuesday, December 10th, 2019, at 13:00 (CET) to provide an update regarding the data presented December 7-8 at the American Society Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2019 (Press release, Oncopeptides, DEC 6, 2019, View Source [SID1234552003]). The webcast will be hosted by CEO Jakob Lindberg.

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On December 6, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), and Inceptua Medicines Access (a business unit of the Inceptua Group), a global pharmaceutical company and service partner, reported that they have entered into a collaboration to make available intravenous rigosertib via a Pre-approval Access Program in selected countries around the world (Press release, Onconova, DEC 6, 2019, View Source [SID1234552002]).

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Pre-approval Access Programs (also known as expanded access, early access, compassionate use, named patient supply) are regulatory-compliant processes permitting experimental agents in development to be made available upon the request of a physician or a patient for appropriate patients for whom no alternative treatment option exists in their country. Rigosertib is a small molecule that inhibits cellular signaling in cancer cells by acting as a RAS mimetic. Current clinical development of rigosertib is centered upon the therapeutic management of MDS, a heterogeneous group of bone marrow disorders characterized by ineffective hematopoiesis that often develop into acute myeloid leukemia (AML). Rigosertib, in its intravenous formulation, is currently in Phase 3 clinical development for the treatment of higher-risk MDS.

The rigosertib Pre-approval Access Program is expected to launch in first half of 2020 and will allow Inceptua to supply intravenous rigosertib within designated countries, primarily and initially concentrated in selected countries in Europe, in response to physician requests for patients with higher- risk MDS who have exhausted all available treatment options, and are not eligible for or have no access to the INSPIRE study. Under the terms of this agreement, Inceptua will support Onconova through the pre-approval provision of intravenous rigosertib initially into a number of countries including: Australia, Denmark, Finland, France, Ireland, Italy, the Netherlands, Portugal, South Africa, Spain, and the UK.

"Inceptua Medicines Access is delighted to be selected as Onconova’s partner for the Pre-approval Access Program for rigosertib. Higher-risk MDS is a disease with significant unmet need, and we are pleased to be able to support healthcare professionals seeking access to rigosertib, ahead of its commercial launch," said Mark Corbett, EVP, Inceptua Medicines Access.

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, said, "The rigosertib Pre-approval Access Program is a key strategic initiative for Onconova. We are pleased that intravenous rigosertib will be made compliantly available to suitable patients with higher-risk MDS through their physcians in designated countries. The program will run alongside our ongoing Phase 3 INSPIRE Trial, and is expected to continue until commercial launch in such countries. We are pleased to work with Inceptua, given their strong record of administering such programs successfully."

On December 6, 2019 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that they have executed agreements with five investors, including an existing investor, John K. Scott, Jr. (collectively, the "Investors"), to purchase approximately 2.1 million shares of the Company’s common stock, par value $0.001 per share, in a private placement for aggregate gross proceeds to Navidea of approximately $1.9 million (Press release, Navidea Biopharmaceuticals, DEC 6, 2019, View Source [SID1234552001]). The securities to be issued to the Investors will represent approximately 9.3% of the Company’s outstanding common stock after such issuance.

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Navidea intends to use the net proceeds from the private placement to fund its research and development programs, including continuing to advance its Phase 2b and Phase 3 clinical trials of Tc99m tilmanocept in patients with rheumatoid arthritis, and for general working capital purposes and other operating expenses.

"This additional investment in Navidea demonstrates our family’s continued commitment to Navidea and our confidence in the long-term vision of its current board and management. It is very encouraging to us as shareholders to have these additional long-term investors co-investing and supporting the Company. This private placement will help Navidea to continue on the path towards obtaining approval for its rheumatoid arthritis diagnostic product," stated John K. Scott, Jr.

"We are very happy that a group of existing long-term shareholders continues to show faith in the potential of Navidea as well as the continued success of its ongoing RA trials," commented Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The ability to quickly raise $1.9 million without having to pay any fees, give any warrants and at market price was an opportunity that the Company could not pass up. It also gives the Company additional runway to allow for several key milestones that we anticipate in the next few months."

A resale registration statement relating to any future resales of the newly issued shares will be filed with the Securities and Exchange Commission. While the Company expects to close the private placement of approximately 1.2 million shares within the next week, the closing of approximately 900,000 of the private placement shares is conditioned upon and will occur shortly after the U.S. Securities and Exchange Commission informs the Company of its willingness to declare the resale registration statement effective. These securities may not be sold nor may offers to buy be accepted prior to the time that the registration statement becomes effective.