On June 20, 2019 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that it will report financial results for the fourth quarter and fiscal year 2019 before the market open on Wednesday, July 10, 2019 (Press release, AngioDynamics, JUN 20, 2019, View Source [SID1234537198]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

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To participate in the conference call, dial 1-877-407-0784 (domestic) or 1-201-689-8560 (international) and refer to the passcode 13691777.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Wednesday, July 10, 2019, until 11:59 p.m. ET on Wednesday, July 17, 2019. To hear this recording, dial 1-844-512-2921 (domestic) or 1-412-317-6671 (international) and enter the passcode 13691777.

On June 20, 2019 Axial Biotherapeutics, a biotechnology company dedicated to building a unique class of gut-targeted therapeutics for neurodegenerative diseases and neurodevelopmental disorders, reported a direct investment of $10 million from Taiho Ventures, LLC to fund the discovery and development of novel gut-targeted, small molecule approaches in oncology (Press release, Axial Biotech, JUN 20, 2019, View Source [SID1234537197]).

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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

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"Axial has built, and continues to build, an exciting and innovative discovery platform that targets the gut-brain axis but we also believe that additional diseases and disorders outside of CNS can stem from the gut microbiome," said David H. Donabedian, Ph.D., co-founder and CEO of Axial Biotherapeutics. "We are pleased that Taiho Ventures sees the potential of this discovery platform, and we are honored to have their support as we look to progress the breadth and depth of our scientific platform. Just as we have done with the CNS space, we look to reshaping the scientific understanding of oncology with gut-targeted therapies."

"We are excited to partner with Axial as we see astounding potential in its platform approach to drug development beyond CNS indications. As such, we are eager to work with the team to identify therapeutic interventions harnessing the gut-brain axis where the company’s novel technology can be applied," said Sakae Asanuma, President, Taiho Ventures, LLC. "We look forward to supporting David and the Axial team."

As part of this investment, Sakae Asanuma will be joining the Axial Board.

The $10 million investment from Taiho Ventures is an extension of Axial’s previously closed Series B round in February 2019. With this investment, Axial has raised a total of $35 million in its Series B financing. In conjunction with this investment, Axial will maintain control of the new oncology programs and Taiho Ventures will have a first right to negotiate for an exclusive license related to the new programs. Axial retains all of its rights to its existing CNS programs.

On June 20, 2019 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported that Robert Forrester has decided to step down as President and Chief Executive Officer (Press release, Verastem, JUN 20, 2019, View Source [SID1234537196]). Mr. Forrester has agreed to continue serving Verastem Oncology in an advisory capacity.

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Dan Paterson, the Company’s Chief Operating Officer, has been appointed to serve as President and Chief Operating Officer and will assume the leadership of the executive team while the Board of Directors conducts a search to identify a successor. Mr. Paterson will be supported by other members of the senior leadership team, including Chief Financial Officer, Rob Gagnon, whose role is being expanded to include Chief Business Officer.

Mr. Paterson joined Verastem Oncology in 2011 and has served as its Chief Operating Officer since 2014. He brings more than 25 years of experience at healthcare and biotechnology companies, including leadership roles as Chief Business Officer (CBO), Chief Operating Officer (COO) and Chief Executive Officer (CEO), with specific expertise in oncology drug and diagnostic product development, business development and launch planning.

"On behalf of the entire Board, I want to thank Robert for his countless contributions and leadership for the past six years and his unwavering commitment to Verastem Oncology’s patients, employees and shareholders," said Michael G. Kauffman, MD, PhD, Verastem Oncology’s Lead Director. "We remain confident in the growth potential of COPIKTRA and we intend to hire a CEO with commercial expertise who will build on the foundation that Robert has established and execute on our ambitious goals for the future."

"With COPIKTRA, the experienced team and the resources we have in place, we are in a strong position to continue executing on our mission to improve outcomes for patients," said Mr. Paterson. "I look forward to working closely with the Company’s Board, executive leadership, and the broader management team to accelerate the COPIKTRA launch and the future expansion of this important medicine into other hematologic malignancy indications."

"It has been a true honor to serve as the CEO of Verastem Oncology over the past six years," said Mr. Forrester. "I am extremely proud of the Verastem Team, the progress we have made, and our many accomplishments aimed at improving the lives of patients diagnosed with cancer, one patient at a time. I have great confidence in Verastem Oncology’s potential and I will work with the entire team to ensure a seamless transition for all of our stakeholders."

The Company is reiterating its previously issued financial guidance for the full year 2019. The Company continues to expect net product revenue from the sales of COPIKTRA to be in the range of $10-12 million, based on product revenue to date, current run rates and near-term expectations.

On June 20, 2019 DURECT Corporation ("DURECT" or the "Company") (Nasdaq: DRRX) reported that it has entered into a securities purchase agreement with certain investors pursuant to which, subject to the terms and conditions expressed therein, the Company agreed to sell and the investors agreed to purchase 29,000,000 shares of common stock of the Company at a price per share of $0.52 (Press release, DURECT, JUN 20, 2019, View Source [SID1234537195]). The net proceeds, after estimated expenses of the offering payable by the Company, will be approximately $15.0 million. No placement agent or broker dealer was used or participated in the offering. The offering is expected to close on or about June 24, 2019, subject to customary closing conditions.

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A registration statement on Form S-3 (File No. 333-226518) relating to the shares of common stock to be issued in this offering was declared effective by the Securities and Exchange Commission on October 9, 2018. The offering of these securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, copies of which can be obtained on the SEC’s website at www.sec.gov.

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

About DURECT Corporation

DURECT is a biopharmaceutical company actively developing therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR-928, a new chemical entity in Phase 2 development, is the lead candidate in DURECT’s Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury such as Alcoholic

On June 20, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported data from four presentations, including three oral presentations and one poster presentation, at the 15thInternational Conference on Malignant Lymphoma (ICML), being held in Lugano, Switzerland (Press release, TG Therapeutics, JUN 20, 2019, View Source [SID1234537194]). Highlights from all presentations are included below.

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We are excited by the data presented today evaluating umbralisib in patients intolerant to currently approved BTK or PI3K therapies. We believe the data presented continue to show that there are many patients in need of alternative treatment options for whom umbralisib can provide meaningful benefit." Mr. Weiss continued, "We are also pleased to present data from the combination of ublituximab + umbralisib ("U2") plus pembrolizumab in patients with relapsed/refractory CLL and Richter’s transformation. It was encouraging to see that 5 of 6 BTK refractory patients responded to therapy, with 4 of those responders achieving a rapid response to U2 alone at the patient’s first efficacy assessment prior to the addition of pembrolizumab. We are eager to initiate our clinical study of U2 plus TG-1501, our PDL1 inhibitor, in the same patient population and believe the triplet may offer the opportunity for time limited therapy in CLL."

Highlights from the oral presentations include:

Oral Presentation Title: A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib in Patients with Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy

This presentation includes data from patients with CLL who are intolerant to prior BTK or PI3K delta inhibitor therapy who were then treated with single agent umbralisib. To be eligible for the study patients had to have received prior treatment with a BTK inhibitor or a PI3K delta inhibitor and discontinued therapy due to intolerance. Fifty-one patients were evaluable for safety of which 50 were evaluable for Progression Free Survival (PFS).

Highlights:

Umbralisib demonstrated a favorable safety profile in patients intolerant to prior BTK or PI3K delta therapy
Only 12% discontinued due to an umbralisib adverse event, of which only one patient discontinued due to a recurrent adverse event (AE) previously experienced with prior kinase inhibitor therapy
In this relapsed/refractory CLL population, 67% had a high-risk molecular / genetic marker and 6% had an ibrutinib resistance mutation, the estimated median progression free survival (PFS) was 23.5 months
Median overall survival (OS) has not been reached with a median follow-up of 14 months
As of the cut-off date, 58% of patients have been on umbralisib for a duration longer than their prior BTK or PI3k inhibitor
Oral Presentation Title: Phase I/II Study of Umbralisib (TGR-1202) in Combination with Ublituximab (TG-1101) and Pembrolizumab in Patients with Relapsed/Refractory CLL and Richter’s Transformation (RT)

This oral presentation includes data from patients with relapsed or refractory CLL or RT treated with the triple combination of ublituximab, umbralisib, and pembrolizumab. Patients with CLL received 2 cycles of the U2 regimen before pembrolizumab was added for an additional 4 cycles, followed by umbralisib maintenance. Patients with RT received U2 + pembrolizumab for the first 4 cycles, followed by U2 maintenance. Twenty patients were evaluable for safety (11 CLL patients and 9 RT patients) and 19 were evaluable for efficacy (11 CLL and 8 RT). Data highlights include:

The triple combination was well tolerated, with immune mediated toxicities not appearing above what would be expected with either umbralisib or pembrolizumab alone
In this heavily pre-treated cohort with a median of 2 (1-9) prior lines of therapy:
— 91% (10 of 11) Overall Response Rate (ORR) in patients with relapsed/refractory CLL
— 83% (5 of 6) ORR in BTK refractory CLL patients, with 4 of 5 responders achieving a response to U2 alone at the patient’s first efficacy assessment, prior to the addition of pembrolizumab
— 38% (3 of 8) ORR in RT, with two durable complete responses; 1 subject relapsed post-CAR-T in CR for 12 months and 1 subject relapsed post-transplant continuing on study in CR now 20+ months
Additionally, data from the UNITY-NHL MZL cohort and data from TG-1801, the Company’s first-in-class anti-CD47-CD19 bispecific antibody, will be presented during ICML. These presentations were recaps and have been previously presented. Links to full data presentations included below.

Oral Presentation Title: Umbralisib Monotherapy Demonstrates Efficacy and Safety in Patients with Relapsed/Refractory Marginal Zone Lymphoma: A Multicenter, Open-Label, Registration Directed Phase 2 Study

Poster Presentation Title: The novel bispecific CD47-CD19 antibody TG-1801 potentiates the activity of ublituximab-umbralisib (U2) drug combination in preclinical models of B-NHL

Full schedule of data being presented at ICML:

Oral Presentation: A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib in Patients with Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy
— Session Date & Time: Thursday, June 20, 2019 13:45 – 15:15 CEST
– Presentation Time: 15:00 CEST
— Session Title: Session 3 – CLL
— Location: Palazzo dei Congressi, Room A – Main Hall
— Lead Author: Anthony R. Mato, MD, Memorial Sloan Kettering Cancer Center

Oral Presentation: Phase I/II Study of Umbralisib (TGR-1202) in Combination with Ublituximab (TG-1101) and Pembrolizumab in Patients with Rel/Ref CLL and Richter’s Transformation
— Session Date & Time: Thursday, June 20, 2019 17:05 – 18:05 CEST
– Presentation Time: 17:05 CEST
— Session Title: Focus on Non-Clinical and Early Clinical Data with New Combinations
— Location: Palazzo dei Congressi, Cinema Corso
— Lead Author: Anthony R. Mato, MD, Memorial Sloan Kettering Cancer Center

Oral Presentation: Umbralisib Monotherapy Demonstrates Efficacy and Safety in Patients with Relapsed/Refractory Marginal Zone Lymphoma: A Multicenter, Open-Label, Registration Directed Phase 2 Study
— Session Date & Time: Saturday, June 22, 2019 10:15 – 11:15 CEST
– Presentation Time: 10:45 CEST
— Session Title: Focus on Indolent Non-Follicular Lymphoma
— Location: Palazzo dei Congressi, Room A and B
— Lead Author: Pierre-Luigi Zinzani, MD, University of Bologna, Institute of Hematology "L. e A. Seràgnoli"

Poster Presentation: The novel bispecific CD47-CD19 antibody TG-1801 potentiates the activity of ublituximab-umbralisib (U2) drug combination in preclinical models of B-NHL
— Session Date & Time: Wednesday, June 19 (12:00-17:00 CEST), Thursday, 20 (9:00-17:00 CEST) and Friday, June 21 (9:00-18:30 CEST)
— Location: Palazzo dei Congressi, Marquee Parco Ciani
— Lead Author: Marcelo Lima Ribeiro, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Autonomous University of Barcelona, Barcelona, Spain
The data presentations are now available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.