On December 6, 2018 Xspray Pharma AB (publ) ("Xspray" or the "Company") reported the company has successfully carried out a directed share issue at a subscription price of SEK 67 per share (Press release, Xspray, DEC 6, 2018, View Source [SID1234650105]). The subscription price corresponds to a discount of approximately 3 percent compared with today’s VWAP, 6 December 2018. The subscription price has been determined through an accelerated book-building procedure.

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A group of Swedish and international institutional investors, among others Unionen, Third Swedish National Pension Fund and Forth Swedish National Pension Fund, have subscribed for shares in the directed share issue. The Company believes that the flexibility of a placing without pre-emption right for existing shareholders is the most appropriate way to diversify the shareholder base among institutional investors prior to the planned list change of the Company’s share to Nasdaq Stockholm’s main list during 2019, and at the same time raise capital in a time efficient manner.

Following the positive data announced on 10 October 2018 for the Company’s lead product, HyNap-Dasa, the Company intends to use the proceeds from the directed share issue to i) continue development of its product portfolio; ii) develop its product candidates through registration; and iii) accelerate the development of product candidate HyNap-Nilo in order to be ready to launch the product earlier than previously planned.

Per Andersson, CEO, Xspray Pharma, comments:

"As a result of the positive results for the product candidate HyNap-Dasa, presented earlier this fall, we are in a strong position to bring our unique HyNap compositions, comprising a number of protein kinase inhibitors (PKIs), to the market. This is an important step towards becoming a powerhouse for PKIs where we address relevant medical needs and more accessible pharmaceuticals to the cancer market."

The directed share issue is expected to raise proceeds for the Company of approximately SEK 92 million before transaction costs. The subscription price has been determined through an accelerated book-building procedure. The directed share issue will result in an increase of the number of shares in Xspray of 1,370,000, from 13,706,460 to 15,076,460, and an increase in the share capital by SEK 1,370,000, from SEK 13,706,460 to SEK 15,076,460, resulting in a dilution of approximately 9.1 percent.

In connection with the directed share issue, the Company has, with customary exceptions, agreed to a lock-up undertaking on future share issuances for a period of 90 days after the directed share issue. In addition, the management and board of directors have undertaken not to sell any shares in Xspray during the same period, subject to customary exceptions.

Advisers

In conjunction with the capital raising, the Company has engaged Carnegie Investment Bank as bookrunner and adviser, Zonda Partners as adviser and Vinge as legal adviser.

On December 6, 2018 Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company pioneering the use of DARPin therapeutics* to treat serious diseases, reported the continued progress of its pipeline of proprietary therapeutic product candidates in oncology and immuno-oncology, as well as in ophthalmology together with its partner Allergan (Press release, Molecular Partners, DEC 6, 2018, View Source [SID1234531925]).

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On its R&D Day in New York, entitled "Building Tomorrow’s Breakthroughs," the company elaborates on its refined development plans for its most advanced proprietary candidate MP0250 in multiple myeloma (MM). In particular, the company announces its intention to initiate a second phase 2 trial for MP0250 in MM. This complementary trial will recruit patients with relapsed or refractory MM who have failed at least two lines of therapy including a proteasome inhibitor and an immunomodulatory drug (IMiD) and in whom the most recent therapy was IMiD-based. Patients will be treated with MP0250 in combination with Pomalidomide and dexamethasone. The design of the initial phase 2 trial for MP0250 in MM will be updated to recruit patients with a proteasome inhibitor (PI) based regimen as the most recent therapy. Those patients continue to be dosed with MP0250 in combination with Velcade and dexamethasone.

Molecular Partners also presents additional preclinical data on MP0310, its most advanced multi-specific (FAP x 4-1BB) DARPin immuno-oncology compound, which is expected to move into the clinic in 2019. In addition, data on FAP x CD40, a second multi-specific preclinical DARPin therapeutic in immuno-oncology, will be presented.

"I am pleased to report on our progress in oncology and our efforts to build a sustainable pipeline of DARPin therapeutics," said Patrick Amstutz, Chief Executive Officer of Molecular Partners.

Pamela A. Trail, Chief Scientific Officer of the company, added: "Our unique DARPin designs have the potential to translate into novel therapeutics across the landscape of oncology. Going forward, we will focus on several key areas of therapeutic intervention which are in the sweet spot of our DARPin technology."

In addition to an overview of the Molecular Partners clinical and preclinical pipeline, the R&D Day will feature presentations by the following experts:

Dr. Robert Orlowski, Chairman, Ad Interim, Director of Myeloma, Professor of Medicine Departments of Lymphoma/Myeloma and Experimental Therapeutics, MD Anderson Cancer Center
Dr. Yehia Hashad, Vice President and Global Head of Clinical Development, Ophthalmology, Allergan
Logistics
The R&D Day for institutional investors, sell-side analysts, investment bankers, and business development professionals will take place at The Yale Club, 50 Vanderbilt Avenue, New York City, from 11:30 am – 2:30 pm EST. To RSVP email Susan A. Noonan at [email protected].

Attendees are invited to check at 11:30 am EST. The presentations will begin at 12:00 pm, followed by a Q&A session. Lunch will be served.

Audio webcast
A respective audio webcast will be accessible, both live and as a replay, on the investors section of the company’s website, along with the accompanying presentation slides.

Financial Calendar
November 1, 2018 – Q3 2018 Management Statement
December 6, 2018 – R&D Day in New York
February 7, 2019 – Publication of Full-year Results 2018 (unaudited)
March 15, 2019 – Expected Publication of Annual Report 2018
April 16, 2019 – Annual General Meeting
May 9, 2019 – Interim Management Statement Q1 2019
View Source

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics.
The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin molecules for various ophthalmic indications are also in development. The most advanced DARPin therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid tumors and hematological tumors. MP0274, the second-most advanced DARPin drug candidate owned by Molecular Partners, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently in phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG

On December 6, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported that data from the Phase 3 RECOVER clinical study was presented during the 2018 San Antonio Breast Cancer Symposium (SABCS) (Press release, Spectrum Pharmaceuticals, DEC 6, 2018, View Source [SID1234531926]). These data confirm the efficacy and safety of ROLONTIS (eflapegrastim) in reducing the Duration of Severe Neutropenia (DSN) in breast cancer patients treated with chemotherapy. ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) being studied as a treatment for neutropenia in patients undergoing treatment with myelosuppressive cytotoxic chemotherapy.

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"Despite available treatments, neutropenia remains a critical issue for patients undergoing chemotherapy that puts them at risk for developing life threatening infections," said Lee Schwartzberg, MD, FACP, lead investigator, professor of medicine and division chief, hematology/oncology, University of Tennessee Health Science Center, and executive director, UT/West Cancer Center. "The robust data from both Phase 3 studies demonstrate that ROLONTIS has the potential to be a valuable option in the management of neutropenia for patients undergoing treatment with chemotherapeutic agents."

The data released yesterday in a poster presentation from the ROLONTIS Phase 3 RECOVER study (n=237) showed that in Cycle 1, the mean DSN±SD was 0.31±0.688 days for ROLONTIS and 0.39±0.949 days for pegfilgrastim, demonstrating non-inferiority (p<0.0001). The non-inferiority of ROLONTIS for DSN was maintained across all four treatment cycles (all (p<0.0001)). Incidence of severe neutropenia was 20 percent versus 24 percent in the eflapegrastim and pegfilgrastim arms respectively, with a relative risk reduction of 14 percent in favor of eflapegrastim. There were no statistically significant differences on secondary endpoints such as time to absolute neutrophil count (ANC) recovery, depth of ANC nadir, and incidence of febrile neutropenia between treatment arms across all cycles. None of the ≥Grade 3 study drug related adverse events (AE) occurred in >2% of the patients and included hematologic and bone pain related AEs in both arms.

The RECOVER trial is the second ROLONTIS Phase 3 study to meet the primary efficacy endpoint of non-inferiority in mean DSN. Results from ADVANCE, the first ROLONTIS Phase 3 study, were announced at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and presented at the Multinational Association in Supportive Care in Cancer Annual Meeting (MASCC) earlier this year.

"The RECOVER study is the second Phase 3 study to confirm non-inferiority data and comparable safety profile between ROLONTIS and the current standard of care," said Joe Turgeon, chief executive officer of Spectrum Pharmaceuticals. "Data from both studies, which enrolled 643 patients combined, will be used to support the BLA filing which is expected to be submitted by the end of the year. If approved, we look forward to having a unique opportunity to launch and compete in this large market with the first novel G-CSF in more than 15 years."

About RECOVER

The RECOVER study is a Phase 3, randomized, open-label, active-controlled, multicenter study that enrolled 237 breast cancer patients who received docetaxel and cyclophosphamide chemotherapy every 21 days. Patients were randomized in a 1:1 ratio to receive either ROLONTIS (n=118) or pegfilgrastim (n=119). The primary study endpoint was the DSN in Cycle 1 of chemotherapy (absolute neutrophil count [ANC] <0.5×109/L), based on central laboratory assessment of ANC over a 21 day cycle. There were a total of four cycles evaluated in this study. Secondary endpoints included, the DSN in Cycles 2, 3, and 4, time to ANC recovery, depth of ANC nadir and incidence of febrile neutropenia at cycle one. Patients with stage I to stage IIIA breast cancer were treated on day one of each of the four cycles with adjuvant/neo-adjuvant docetaxel and cyclophosphamide. On day two of each cycle, patients received a single subcutaneous dose of either eflapegrastim 13.2 mg/0.6 mL (equivalent to 3.6 mg G-CSF) or pegfilgrastim (6 mg).

On December 6, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE:BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that it will host an investor breakfast meeting on Tuesday, December 11, 2018 at the Convene Conference Center near Grand Central Terminal in New York, N.Y (Press release, BioLineRx, DEC 6, 2018, View Source;p=RssLanding&cat=news&id=2379754 [SID1234531943]).

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The investor meeting schedule is as follows:

7:45 am EST – Registration and breakfast
8:10-9:30 am EST – Formal presentations

Location:

Convene Conference Center
101 Park Avenue South (near Grand Central Terminal)
New York, N.Y.
(888) 730-7307

The event will feature presentations by Ezra Cohen, MD, FRCPSC, FASCO, from UC San Diego, who will discuss the progress made in the clinical development of immunotherapies beyond checkpoint inhibitors; and Manuel Hidalgo, MD, PhD, from Beth Israel Deaconess Medical Center, Harvard Medical School, on the unmet medical need in treating patients with pancreatic cancer. Both KOLs will be available to answer questions at the conclusion of the event.

BioLineRx’s management team will provide an update on the Company’s clinical development of BL-8040 and AGI-134, as well as a review of recent corporate achievements and the Company’s strategy for 2019. BL-8040 is a short peptide that functions as a high-affinity antagonist for CXCR4 in late clinical development for the treatment of solid tumors, acute myeloid leukemia (AML) and stem-cell mobilization for bone-marrow transplantation. AGI-134 is a synthetic αGal novel immunotherapy currently in Phase 1/2a development for solid tumors.

Ezra Cohen, MD, is co-Director of the San Diego Center for Precision Immunotherapy and an internationally renowned translational researcher. A physician-scientist, his recent National Institutes of Health-funded work in the study of epidermal growth factor receptor inhibitors in head and neck cancer has contributed to the understanding of the biology of this critical signaling network, integration of these agents into standard of care, and definition of mechanisms to overcome resistance. He recently served as chair of the NCI Head and Neck Cancer Steering Committee that oversees NCI-funded clinical research (including all NCI Cooperative Group trials) in this disease. Dr. Cohen is also Associate Director for Translational Science and leader of the Solid Tumor Therapeutics research program at Moores Cancer Center. Among other roles, he is chair of the Protocol Review and Monitoring Committee (PRMC) and serves as a member of the Cancer Council, and the Cancer Center’s Executive Committee. He has also been the principal investigator on multiple studies of novel agents in head and neck cancer and other solid tumors in all phases of development. Dr. Cohen recently served as editor-in-chief of Oral Oncology.

Manuel Hidalgo, MD, PhD, is Director of the Leon V. & Marilyn L. Rosenberg Clinical Cancer Center and Chief of the Division of Hematology-Oncology at Beth Israel Deaconess Medical Center (BIDMC). He is also the Theodore W. and Evelyn G. Berenson Professor of Medicine at Harvard Medical School. An internationally renowned oncologist, Dr. Hidalgo is a world leader in the testing and development of new agents for pancreatic and other solid tumor cancers. He oversees all BIDMC clinical cancer programs. Dr. Hidalgo is a founder of the Pancreatic Cancer Research Team (PCRT), a private nonprofit cooperative group dedicated to rapid drug development in pancreatic cancer. He is a former member of the Science Committee of Cancer Research UK and a member of the Special Conferences Committee of the American Association of Cancer Research and Scientific Advisory Board of Pancreatic Cancer Action Network. He is also the Director of the Vail Course "Methods on Clinical Cancer Research." Dr. Hidalgo is scientific editor of Cancer Discovery.

This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay of the event will be accessible here. If you would like to ask a question during the live Q&A portion of the event, please submit your request via email.

On December 6, 2018 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported it has filed a request with the U.S. Food and Drug Administration ("FDA") for Orphan Drug Status for its drug candidate WP1066 (Press release, Moleculin, DEC 6, 2018, View Source [SID1234531927]).

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"Clinical progress with WP1066 has been encouraging," commented Walter Klemp, Moleculin’s Chairman and CEO. "Given its potential to address rare and difficult to treat cancers, including glioblastoma, we believe WP1066 is well positioned to qualify for Orphan Drug Status."

The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.