On March 20, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported it will present safety and biomarker data for DV281, its inhaled TLR9 agonist, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, being held March 29 – April 3, in Atlanta, Georgia (Press release, Dynavax Technologies, MAR 20, 2019, View Source [SID1234534546]).

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Abstract Number and Title: #8304, "Phase Ib/II, open label, multicenter study of inhaled DV281, a Toll-like receptor 9 agonist, in combination with nivolumab in patients with advanced or metastatic non-small cell lung cancer (NSCLC)"

Poster Session Title: Phase I-III Trials in Progress: Part 3

Session Date and Time:Tuesday, April 2, 2019, 1 – 5 p.m. ET

Session Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 17, Poster Board Number: #18

Permanent Abstract Number: CT224

About DV281
DV281 is Dynavax’s proprietary investigational TLR9 agonist designed specifically for focused delivery to primary lung tumors and lung metastases. DV281 is similar in biological activity and mechanism of action to Dynavax’s Phase 2 immunotherapy candidate, SD-101, but has been optimized for administration as an inhaled therapy. Both SD-101 and DV281 activate plasmacytoid dendritic cells which then stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as DV281 and SD-101 have been shown to stimulate potent Type 1 interferon induction along with maturation of dendritic cells to effective antigen-presenting cells; both activities are important for the induction of effective anti-tumor immunity.

On March 20, 2019 Fresenius Medical Care, the world’s largest provider of dialysis products and services, reported that it has appointed Dr. Frank Maddux as Global Chief Medical Officer (Press release, Fresenius, MAR 20, 2019, View Source [SID1234534494]). With this newly created position the company further advances the great importance of applying clinical science at an ever-higher level. This includes also the facilitation of enhanced cooperation and exchange of knowledge across the entire Fresenius Medical Care network to ensure high-quality outcomes for patients worldwide.

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Rice Powell, Chief Executive Officer of Fresenius Medical Care and Chairman of the Management Board, said: "Each of us understands that the well-being of our patients is our priority, and key to the company’s success all over the world. To continuously deliver on this commitment, it is becoming increasingly important that we also coordinate the interpretation of clinical science and medical practice patterns on a global basis. With Dr. Maddux we have a Global Chief Medical Officer with a well-deserved, excellent reputation inside and outside our company. He will ensure that we utilize the benefits of our global, vertically integrated approach to achieve the best clinical outcomes for our patients, their families and the payor community as well. Our Medical Office led by Dr. Maddux will be key to our ability to drive value for our patients by pursuing new and evolving medical opportunities, such as a more focused home therapies offering, regenerative medicine or enhancing our care coordinated business model throughout the world."

Dr. Maddux is a physician, IT entrepreneur and health care executive with more than 30 years of health care experience. He has been working for Fresenius Medical Care since 2009. Most recently Dr. Maddux served as Executive Vice President for Clinical & Scientific Affairs and Chief Medical Officer for Fresenius Medical Care North America with responsibility for the delivery of high-quality, value-based care for the largest integrated renal care network in the U.S. His outstanding expertise and research interests have been focused on the quality of care for chronic kidney disease patients.

On March 20, 2019 Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, reported the closing of its previously announced registered direct offering of 1,200,000 shares of its common stock at a price of $2.50 per share (Press release, Vaxart, MAR 20, 2019, View Source [SID1234534511]). Total gross proceeds from the offering were $3.0 million, before deducting placement agent fees and estimated offering expenses.

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H.C. Wainwright & Co. acted as the exclusive lead placement agent for the offering. Brookline Capital Markets, a division of CIM Securities, LLC, acted as the co-placement agent for the offering.

The securities described above were offered by Vaxart pursuant to a registration statement on Form S-3 (File No. 333-228910) previously filed with and subsequently declared effective by the Securities and Exchange Commission (SEC) on March 15, 2019. A prospectus supplement and accompanying base prospectus relating to the shares of common stock offered were filed with the SEC on March 20, 2019. Copies of the prospectus supplement and accompanying base prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction

On March 20, 2019 Innate Pharma (the "Company" – Euronext Paris: FR0010331421 – IPH) reported its consolidated financial results for the year ended December 31, 2018. The consolidated financial statements are attached to this press release (Press release, Innate Pharma, MAR 20, 2019, View Source [SID1234534495]).

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"2018 was a remarkable year for Innate during which two of our lead programs, monalizumab and IPH4102, demonstrated promising efficacy in their lead indications. In addition to this, the transformational deal signed with AstraZeneca not only validates our novel science and clinical development expertise, but accelerates the transition of Innate Pharma to become a fully-integrated biotech company," commented Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "The acquisition of FDA-approved Lumoxiti for third line Hairy Cell Leukemia patients complements our proprietary pipeline of promising assets. The planned commercial infrastructure in the US will not only provide Innate with the necessary footprint to support the continued roll-out of this product, but will also be leveraged for potential future products such as IPH4102. We are pleased to welcome Jennifer Butler to our leadership team as the US General Manager who will lead the strategy, operations, and hiring of talent in the US. In 2019, we are committed to executing a smooth commercial transition, expanding our presence in the US and will continue to secure financial resources to invest in our science to discover and develop novel therapeutics for oncology patients."

A conference call will be held today at 2:00pm (CEST)
Management Participants: Mondher Mahjoubi, CEO, Laure-Helene Mercier, CFO, Pierre Dodion, CMO, and Jennifer Butler, US General Manager

Dial in numbers:

France and International: +33 (0)1 72 72 74 03 US only: +1 646 722 4916

PIN code: 45649727#

The presentation will be made available on the Company’s website 30 minutes before the conference begins.

A replay will be available on Innate Pharma’s website after the conference call.

Financial highlights for 2018:
The key elements*** are as follows:

Cash, cash equivalents and financial assets amounting to €202.7m (million euros) as of December 31, 2018 (€176.6m as of December 31, 2017), including non-current financial instruments (€35.2m). This follows the receipt in October of €102.9m as a first tranche of the agreement signed with AstraZeneca in October 2018.
At the same date, the financial liabilities amounted to €4.5m (€5.9m as of December 31, 2017).
Revenue and other income amounting to €94,0m (€36.2m in 2017). This figure mainly results from licensing revenue (€79.9m) and from research tax credit (€13.5m).
Revenue from collaboration and licensing agreements mainly results from the spreading of the initial payment of $250m received in 2015 by Innate Pharma in the context of the agreement with AstraZeneca for monalizumab signed in April 2015, extended in October 2018 with an additional $100m payment (€61.5m and €24.5m in 2018 and 2017 respectively) but also, €15.6m from the spreading of the initial payment of $50m for the agreement with AstraZeneca on IP5201 signed in October 2018
Operating expenses amounting to €87.7m (€76.0 m in 2017) of which 79% related to research and development outgoings. The increase in R&D expenses between 2017 and 2018 reflects continued investment in the clinical and preclinical development programs, as well as support for the broader organization.
Net income (loss) from distribution agreements amounting to a loss of €1.1 million, arising from the launch of Lumoxiti in the US.
A net financial loss amounting to €2.4m.
As a consequence of the items mentioned previously, the net profit for 2018 amounts to €3.0m, compared with a loss of €41.7m for 2017.
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* current and non-current.

** Of which $118m received as of December 31, 2018 and $74m reiceived as of January 31, 2019, subsequent to the AstraZeneca deal signed, net from the payment for the acquisition of Lumoxiti.

*** The elements as of December 31, 2018 are compared to December 31, 2017 restated numbers, which are not audited and take into account the impact of IFRS 9 and 15 on 2017 financial statements.

On March 20, 2019 Cellular Biomedicine Group Inc. (Nasdaq: CBMG) (CBMG or the Company), a biopharmaceutical company engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering (Press release, Cellular Biomedicine Group, MAR 20, 2019, View Source [SID1234534514]). CBMG also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the offering, at the public offering price, less the underwriting discounts and commissions. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares in the offering are to be sold by CBMG, with net proceeds to be used for preclinical studies, clinical trials, continued technology platform development, as well as for working capital and other general corporate purposes.

Cantor Fitzgerald & Co. and Robert W. Baird & Co. Incorporated are serving as joint book-running managers for the offering.

The shares of common stock described above are being offered by CBMG pursuant to a shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (or SEC) and declared effective by the SEC on June 17, 2016. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement relating to these securities may also be requested by sending a request to: Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at [email protected]; or Robert W. Baird & Co. Incorporated, Attention: Syndicate Department, 777 East Wisconsin Ave., Milwaukee, WI 53202, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

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