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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.
————–
* 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On March 20, 2019 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) and Eli Lilly and Company (NYSE: LLY) reported six projects that aim to improve the delivery of gastric and gastroesophageal junction (GEJ) cancer care in the United States (Press release, Eli Lilly, MAR 20, 2019, View Source [SID1234554022]). The quality improvement studies will focus on methods of intervention that can be implemented across a variety of different oncology practice settings. These projects are eligible to receiving funding from Lilly Oncology after completing contract negotiations. Forty-nine letters of intent were submitted in response to the RFP and subsequently 19 full proposals were requested for review.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As part of our mission to facilitate care that helps patients live better lives, we’re honored to support research that enhances outcomes and experiences for people with gastric and gastroesophageal junction cancers," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "This project is intended to identify disparities in care between the community and academic setting, and define scalable, shareable solutions that will rapidly improve adherence to guidelines and quality of care."

The following studies were selected by the NCCN ORP:

Dan G. Blazer III, MD; Daniel P. Nussbaum, MD; Linda M. Sutton, MD; Duke University Health System and Duke Cancer Network Affiliates; The DCN Passport: A Novel, Patient-Centered Approach to Improve Care for Gastric/Gastroesophageal Junction Cancer Across an Academic-Community Oncology Network
Efrat Dotan, MD; Fox Chase Cancer Center; Improving the Approach to and Management of the Older Patient with Metastatic Gastric Cancer
Jae Kim, MD; City of Hope National Medical Center; Telehealth Intervention for Self-Management of Dietary Quality of Life After Gastric Cancer Surgery
Veena Shankaran MD, MS; University of Washington/Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Center; Randomized Pragmatic Trial of a Proactive Financial Navigation Intervention in Patients with Newly Diagnosed Gastric and Gastroesophageal Junction Adenocarcinoma
Qiuling Shi, PhD; Loretta A. Williams, PhD; The University of Texas MD Anderson Cancer Center; Symptom Management Through an Automated Alert System to Improve Adherence During Systemic Therapy for Patients with Gastric/Gastroesophageal Junction (GEJ) Cancer
Kuang-Yi Wen, PhD; Sidney Kimmel Cancer Center (SKCC) at Jefferson; mChemoCoping – GC: A Text Messaging System Enabling Real-Time Monitoring and Management of Chemotherapy Side Effects Among Patients with Gastric Cancer (GC)
"NCCN ORP congratulates all of the collaborators, and looks forward to their contributions to the future of gastric and GEJ cancer care," said Dr. Koh.

"Lilly is proud to work with the NCCN ORP to research better ways for delivering high-quality cancer care to patients with this aggressive disease," said Maura Dickler, MD, Vice President of Late Phase Development, Lilly Oncology. "By utilizing novel approaches and advancing technology, these studies will help us to address some of the largest disparities in care that exist for patients undergoing treatment for gastric and GEJ cancers."

The NCCN ORP was responsible for the Request-for-Proposals (RFP) process, application review and evaluation. A committee led by NCCN and including a medical representative from Lilly determined which proposals would be eligible to receive funding. Project funding will be provided directly by Lilly upon mutual agreement of project terms and conditions.

The studies will be conducted over a period of two years.

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer by supporting investigator-initiated trials at NCCN Member Institutions and their affiliates. To date, it has supported more than 140 studies, with numerous publications in peer-reviewed journals. To learn more about the NCCN ORP and ongoing clinical trials, visit NCCN.org/ORP.

On March 20, 2019 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the full year ended December 31, 2018 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAR 20, 2019, View Source [SID1234534496]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Throughout 2018, we made great progress in pursuit of our mission of bringing innovative new RNAi nanoparticle therapeutics to cancer patients with high unmet medical need," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "This progress was highlighted by the recent updated interim analysis of our Phase 2 trial of prexigebersen in acute myeloid leukemia (AML). Of the 17 evaluable patients, 65% had a response, including 29% who achieved a complete response, one of which achieved a morphologic leukemia free state. With these interim results in hand, we are even more confident as we move this program forward in combination with venetoclax and decitabine."

"Beyond prexigebersen, we continue to make headway across our development pipeline. We are on track to submit our Investigational New Drug application to begin a Phase 1 study of our second drug candidate, BP1002, which targets the Bcl-2 protein. This trial will seek to treat both Non-Hodgkin’s Lymphoma and chronic lymphocytic leukemia patients that have failed Venetoclax. We recently strengthened our balance sheet through a $18.5 million registered direct offering and we now have the resources to achieve a number of key milestones that should significantly enhance shareholder value. We entered 2019 on strong footing and expect to build on that momentum throughout the balance of the year as we continue to advance these important programs," continued Mr. Nielsen.

Recent Corporate Highlights

·Reported Updated Interim Analysis from Phase 2 Clinical Trial of Prexigebersen for the Treatment of AML. In March 2019, Bio-Path reported updated interim data from 17 evaluable patients showing that 11 patients (65%) had a response, including five patients (29%) who achieved CR, one of which was a morphologic leukemia free state (MLFS), and six patients achieving stable disease. Importantly, after further analysis by the principal investigators, it was observed that 68% of these patients were secondary AML patients, an extremely difficult class to treat. As a result of these updated data, Bio-Path now intends to enroll two registration-directed cohorts of the triple combination of prexigebersen + decitabine + venetoclax in untreated AML and high risk MDS patients, and refractory/relapsed AML and high risk MDS patients. In December 2018, earlier data from this program were presented in a poster at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

·Raised $18.5 Million in Registered Direct Offering. In March 2019, Bio-Path issued 712,910 shares of its common stock at a price of $25.95 per share, for gross proceeds of approximately $18.5 million.

Financial Results for the Full Year Ended December 31, 2018

·The Company reported a net loss attributable to common stockholders of $8.6 million, or $14.38 per share, for the year ended December 31, 2018, compared to a net loss attributable to common stockholders of $8.1 million, or $15.99 per share, for the year ended December 31, 2017.

·Research and development expenses for the year ended December 31, 2018 decreased to $4.6 million, compared to $5.5 million for the year ended December 31, 2017 primarily due to decreased salaries and benefits expense.

·General and administrative expenses for the year ended December 31, 2018 decreased to $3.4 million, compared to $3.5 million for the year ended December 31, 2017 primarily due to decreased professional and consulting fees.

·As of December 31, 2018, the Company had cash of $1.0 million, compared to $6.0 million at December 31, 2017. Net cash used in operating activities for the year ended December 31, 2018 was $6.1 million compared to $8.0 million for the comparable period in 2017. Net cash provided by financing activities for the year ended December 31, 2018 was $1.2 million.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these full year 2018 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 1794629. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.