Celyad to Present Updates on CYAD-01 at the American Association for Cancer Research (AACR) Annual Meeting 2018

On March 29, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD) a clinical-stage biopharmaceutical company focused on the development of CART-cell therapies, reported that the company will present updates on its ongoing Phase I clinical trials at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 14–18, 2018, in Chicago (Press release, Celyad, MAR 29, 2018, View Source [SID1234532518]). Poster presentations will feature updated data from Celyad’s THINK[1] trial, the new SHRINK[2] and LINK[3] trials in metastatic colorectal cancer, as well as data from a preclinical study showing that the addition of either the CD28 or 4-1BB co-stimulatory domains to CYAD-01 construct brings no benefit in terms of in vitro activity of the receptor.

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Poster Presentation Details:

Poster Title: The THINK clinical trial: Preliminary evidence of clinical activity of NKG2D chimeric antigen receptor T cell therapy (CYAD-01) in acute myeloid leukemia.

Poster Number: CT129

Session Title: Phase I Trials in Progress

Session Date & Time: Tuesday, April 17, 2018, 8:00 AM – 12:00 PM CDT

Location: Mc Cormick place south, Exhibit Hall A, Poster Section 42, Poster Board 12

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Poster Title: The SHRINK clinical trial: A phase I study assessing the safety and clinical activity of multiple doses of an NKG2D-based CAR-T therapy, CYAD-01, administered concurrently with the neoadjuvant FOLFOX treatment in patients with potentially resectable liver metastases from colorectal cancer.

Poster Number: CT123

Session Title: Phase I Trials in Progress

Session Date & Time: Tuesday, April 17, 2018, 8:00 AM – 12:00 PM CDT

Location: Mc Cormick place south, Exhibit Hall A, Poster Section 42, Poster Board 6

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Poster Title: The LINK clinical trial: A phase I study assessing the safety and clinical activity of multiple hepatic transarterial administrations of an NKG2D-based CAR-T therapy, CYAD-01, in patients with unresectable liver metastases from colorectal cancer.

Poster Number: CT134

Session Title: Phase I Trials in Progress

Session Date & Time: Tuesday, April 17, 2018, 8:00 AM – 12:00 PM CDT

Location: Mc Cormick place south, Exhibit Hall A, Poster Section 42, Poster Board 17

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Poster Title: NKG2D as a chimeric antigen receptor – DAP 10 provides optimal co-stimulation for NKG2D based CARs.

Session Title: Adoptive Cell Therapy 3

Poster Number: 3583

Session Date & Time: Tuesday, April 17, 2018, 8:00 AM – 12:00 PM CDT

Location: Mc Cormick place south, Exhibit Hall A, Poster Section 24, Poster Board 21

Altimmune Announces Financial Results for the Year Ended December 31, 2017 and Provides Corporate Update

On March 29, 2018 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported financial results for the year ended December 31, 2017 (Press release, Altimmune, MAR 29, 2018, View Source [SID1234525052]).

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Corporate Highlights

Enrolled first two cohorts of government funded Phase 1 trial of NasoShield, an intranasal vaccine against anthrax infection

Positive data in two Phase 2 clinical programs:

Announced positive proof-of-concept Phase 2 flu vaccine trial results with our NasoVAX vaccine

Announced positive pre-clinical data from the Company’s SparVax-L trial comparing SparVax-L and BioThrax against anthrax infection

Extended its IP protection of NasoShield in the U.S. with a Notice of Allowance from the U.S. Patent Office

Elected Mitchel Sayare, Ph.D., as Chairman of its Board of Directors

Raised approximately $30 million in financing, including through a Series B preferred offering, cash acquired in connection with the reverse merger with PharmAthene and a pre-merger private placement with existing investors, providing cash into the first quarter of 2019
"We have had a very data-rich few weeks with results being reported from our NasoVAX, HepTcell, and SparVax-L programs and moving forward on enrollment in our Phase 1 trial of NasoShield," said William J. Enright, Chief Executive Officer of Altimmune. "We are very excited by the positive results from our NasoVAX trial and look forward to continuing to advance that program. NasoVAX is a very different type of flu vaccine that has tremendous potential as an effective, easy-to-use vaccine that potentially provides better protection than current vaccines. We are also excited by the results on our SparVax-L trial and look forward to moving that program forward once we secure additional government funding. We continue to evaluate our HepTcell results will update investors on our next steps as we better understand those results."

Mr. Enright continued, "operationally, we are pleased with our progress. In 2017 we closed the reverse merger with PharmAthene, allowing us to leverage our resources and create a focused immunotherapeutics company. We strengthened our scientific team with the promotion of Dr. Sybil Tasker to Chief Medical Officer in early 2017. Additionally, in January 2018, Mitchel Sayare, Ph.D. was elected as Chairman of our Board of Directors bringing in-depth biotechnology experience as the former CEO of Immunogen. We anticipate continuing to build on our momentum in 2018 as we move forward with our NasoVAX, SparVax-L and NasoShield programs."

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Financial Results for the Year Ended December 31, 2017

Revenue for the year ended December 31, 2017 was $10.7 million compared to $3.2 million for 2016. The increase was due to $5.7 million increase in revenue from our contract with BARDA and $1.8 million revenue from the NIAID contract we assumed from our merger with PharmAthene in May 2017.

Research and development expenses were $18.4 million for the year ended December 31, 2017 compared to $7.2 million for 2016. The increase in research and development expenses was primarily the result of increases relating to NasoShield, NasoVAX, HepTcell, and SparVax-L clinical and preclinical trial costs, partially offset by $0.5 million reduced spending on the Oncosyn program. Research and development expenses for the year ended December 31, 2016 did not include PharmAthene or costs incurred under the NIAID contract.

General and administrative expenses were $8.5 million for the year ended December 31, 2017, compared to $7.1 million for 2016. The increase was the combined result of increased professional fees related to the merger with PharmAthene and costs incurred by us as a public company, including insurance costs and stock compensation expense, offset by $2.4 million of costs related to our initial public offering incurred in 2016 that did not recur in 2017.

We determined that our goodwill was impaired and a non-cash goodwill impairment charge of $35.9 million was recorded during the year ended December 31, 2017 which was classified as a component of operating expenses. The non-cash charge resulted from our goodwill assessment based on our market capitalization plus an implied control premium relative to the carrying value of our net assets. The non-cash charge has no effect on our current cash balance or operating cash flows.

We recorded an income tax benefit of $5.6 million during the year ended December 31, 2017, which reflected estimated tax refunds we expect to receive from carrying back our 2017 net operating losses to offset the 2016 federal and state income taxes paid by PharmAthene.

Net loss attributable to common stockholders for the year ended December 31, 2017 was $51.4 million compared with $11.5 million for 2016. Excluding the non-cash goodwill impairment charges, net loss attributable to common stockholders for the year ended December 31, 2017 was $15.4 million compared to $11.5 million for 2016.

Net loss per share attributable to common stockholders for the year ended December 31, 2017 was ($4.01) compared with ($1.66) for 2016. Excluding the non-cash goodwill impairment charges, net loss per share attributable to common stockholders for the year ended December 31, 2017 was ($1.21), compared to ($1.66) for 2016.

At December 31, 2017, the Company had cash, cash equivalents, and restricted cash of approximately $12.3 million, of which $3.5 million was restricted under the terms of the Series B preferred offering.

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Non-GAAP Measures

To supplement the Company’s unaudited financial statements presented in accordance with generally accepted accounting principles ("GAAP"), this press release includes a discussion of adjusted net loss attributable to common stockholders and adjusted net loss per share attributable to common stockholders, in each case adjusted for the loss due to a goodwill impairment charge. The Company believes that these non-GAAP measures, when taken into consideration with the corresponding GAAP financial measures, provide investors with meaningful comparisons of current results to prior period results by excluding items that the Company does not believe reflect its fundamental business performance. See the attached schedule for a reconciliation of net loss to adjusted net loss and loss per share to adjusted loss per share for the twelve months ended December 31, 2017 and 2016.

Can-Fite to Present at the MicroCap Conference

On March 28, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small-molecule drugs that address cancer, liver disease and inflammatory diseases, announced today that it will be presenting at the MicroCap Conference, being held on April 9-10 at the Essex House, New York City (Press release, Can-Fite BioPharma, MAR 28, 2018, View Source [SID1234525023]). Can-Fite’s Chief Financial Officer, Motti Farbstein will be delivering the corporate presentation and showcasing the Company’s lead drug candidate, Piclidenoson (CF101), which is in a Phase III trial for rheumatoid arthritis, and Namodenoson (CF102), a liver cancer drug in Phase II trials. Mr. Farbstein will also be hosting a Q&A session with investors and conducting one-on-one meetings.

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bluebird bio and Celgene Corporation Enter into Agreement to Co-Develop and Co-Promote Anti-BCMA CAR T Cell Therapy bb2121 in the United States

On March 28 bluebird bio, Inc. (Nasdaq: BLUE) and Celgene Corporation (Nasdaq: CELG) reported that the companies have entered into an agreement to co-develop and co-promote bb2121, an investigational anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy for the potential treatment of patients with relapsed/refractory multiple myeloma in the United States (Press release, Celgene, MAR 28, 2018, View Source [SID1234525025]).

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This press release features multimedia. View the full release here: View Source

"Entering into this co-development and co-promotion partnership with Celgene is a significant step forward in building a fully integrated oncology franchise for bluebird and together, we are committed to rapidly advancing development of bb2121 for patients," said Joanne Smith-Farrell, Ph.D., oncology franchise leader and senior vice president, corporate development and strategy, bluebird bio. "The collaboration builds upon our extensive research and development capabilities in oncology and is a testament to the strong partnership that exists between our two companies."

The companies originally entered into a broad, global strategic research collaboration in 2013 to discover, develop and commercialize novel therapies in oncology, which included bb2121.

"We are extremely pleased to advance our collaboration with bluebird on bb2121 and we believe this therapy has the potential to significantly impact the treatment approach and outcomes for patients with multiple myeloma," said Nadim Ahmed, President, Hematology and Oncology for Celgene.

Histogenics Corporation to Present at Upcoming Investor Conferences

On March 28, 2018 Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, reported that Company Management will be presenting at two upcoming healthcare investor conferences (Press release, Histogenics, MAR 28, 2018, View Source;p=RssLanding&cat=news&id=2340115 [SID1234525026]).

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H.C. Wainwright Global Life Sciences Conference – Monte Carlo, Monaco (April 8-10, 2018)

Jonathan Lieber, Histogenics’ CFO, will present a corporate overview on Tuesday, April 10, 2018 at 11:55a.m. CEST / 5:55 a.m. EDT.
Alliance for Regenerative Medicine 6th Annual Cell and Gene Investor Day – New York, NY (April 17, 2018)

Sponsored by the Alliance for Regenerative Medicine, the conference provides institutional, strategic and venture investors a unique opportunity to gain insight into over 30 leading cell and gene therapy companies. Mr. Lieber will present a corporate overview on Tuesday, April 17, 2018 at 9:10 a.m. EDT.
To access live audio webcasts of the presentations on the "Investor Relations" page of the Histogenics website, please click here. The webcasts will be available for approximately 45 days following the respective conferences.