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 Stemline Therapeutics, Inc. (Nasdaq: STML), a biopharmaceutical company focused on the development and potential commercialization of novel oncology therapeutics, reported that updated data from multiple ELZONRISTM (tagraxofusp; SL-401) clinical trials at the 2018 ASH (Free ASH Whitepaper) Annual Meeting (Press release, Stemline Therapeutics, DEC 6, 2018, View Source [SID1234531924]). Presentations are now available on the Stemline website, www.stemline.com, under the Scientific Presentations tab.

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Key Outcomes from Pivotal Trial of ELZONRIS in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Across all 3 stages, 42 patients received ELZONRIS (12 ug/kg/day)
• In first-line patients with BPDCN, ELZONRIS (12 ug/kg/day)
– 90% (26/29) overall response rate (ORR)
– 72% (21/29) rate of CR + CRc (complete response + clinical CR [CR with residual skin abnormality])
– 45% (13/29) of patients were bridged to stem cell transplant (SCT)
• In relapsed/refractory patients with BPDCN, ELZONRIS (12 ug/kg/day)
– 69% (9/13) ORR
– 38% (5/13) CR + CRc + CRi rate
– 1 patient was bridged to SCT
• Median overall survival (OS) was not yet reached in first-line patients treated with ELZONRIS at 12 ug/kg/day across all stages. Median follow up time is 23.0 months (range of 0.2 – 41+ months)
• Most common treatment-related adverse events (TRAEs) in all patients treated across all trials at 12 ug/kg/day dose (N=148) were: alanine aminotransferase increase (43.9%), aspartate aminotransferase increase (43.9%), hypoalbuminemia (43.9%), and thrombocytopenia (26.4%). TRAEs included capillary leak syndrome (CLS) (16.9%) which was grade 5 in 1.5% (3/202) of patients across all trials and doses and 0.6% (1/166) of patients across all trials at 12 ug/kg/day; a myocardial infarction, grade 5, occurred in a patient (12 ug/kg/day) with grade 4 CLS, as previously reported.

Stage 3 pivotal cohort (13 first-line BPDCN patients treated with SL-401 at 12 ug/kg/day):
• Met its primary endpoint with a 54% (7/13) CR + CRc rate (95% CI: 25.1, 80.8)
• 77% (10/13) ORR
• 46% (6/13) of patients were bridged to SCT
In the U.S., the ELZONRIS biologics license application (BLA) is under Priority Review, with a February 21, 2019 PDUFA action date

In the E.U., the European Medicines Agency (EMA) has granted accelerated assessment to the planned Marketing Authorization Application (MAA), which is expected to be submitted in the first quarter of 2019
Key Outcomes from Ongoing Clinical Trial of ELZONRIS in Patients with Relapsed/Refractory Chronic Myelomonocytic Leukemia (CMML)

ELZONRIS demonstrated efficacy (spleen and bone marrow responses), with a manageable safety profile, in patients with relapsed/refractory CMML, an area of unmet medical need

100% of evaluable patients had reduction in baseline splenomegaly
– 80% had reduction by ≥50%
– 67% with baseline spleen size ≥5cm had reduction by ≥50%

3 bone marrow complete responses (BMCRs)

1 patient bridged to stem cell transplant in remission on ELZONRIS

Most common TRAEs include hypoalbuminemia (35%), thrombocytopenia (35%), nausea (30%) and vomiting (30%). Most common TRAEs, grade 3+, include thrombocytopenia (35%) and nausea (5%). CLS was reported in 15% of patients, with no cases of grade 3 or higher observed

Splenomegaly has historically been associated with serious sequelae including early satiety and intractable pain, as well as poor transplant outcomes and a higher propensity for AML transformation

Targeting the proliferative component of CMML, namely alleviation of splenomegaly, could result in meaningful clinical benefit and address a key unmet medical need
Next Steps

Patient enrollment and follow up continues, and additional updates are planned in 2019

Based on the encouraging results seen in this trial, a registrational trial design, or pivotal cohort, is being designed
Key Outcomes from Ongoing Trial of ELZONRIS in Patients with Relapsed/Refractory Myelofibrosis

ELZONRIS monotherapy demonstrated efficacy (improvements in splenomegaly), with a manageable safety profile, in patients with relapsed/refractory MF, an area of unmet medical need; Patient enrollment and follow up continues

100% of evaluable patients with monocytosis and baseline spleen size ≥5cm, had reduction in baseline splenomegaly
– 80% had reduction by ≥29%; 40% had reduction by ≥45%
– Historically, monocytosis has been associated with poor prognosis in certain MF patients

57% of evaluable patients, with baseline spleen size ≥5cm, had reduction in baseline splenomegaly
– 43% had reduction by ≥29%; 21% had reduction by ≥45%

6 patients with spleen response had treatment duration of 6+ months; 5 patients ongoing
– 5 patients with baseline thrombocytopenia (platelet count <100K) had treatment duration of 6+ months; 4 ongoing
– 3 patients with baseline monocytosis (>1×109/L) had treatment duration of 8+ months; 2 patients ongoing

Initial quality of life (QOL) assessments appear promising; full symptom score analyses are ongoing

Most common TRAEs include headache and hypoalbuminemia (each 22%), and alanine aminotransferase increased and thrombocytopenia (each 17%). The most common TRAE, grade 3+, was thrombocytopenia (8%). There was one case of CLS, which was grade 3.
Next Steps

Patient enrollment and follow up continues, and additional updates are planned in 2019

Based on these encouraging results, next steps are being evaluated including single agent, combination, and registration-directed trials in patients with relapsed/refractory MF, including in poor-prognosis MF patients with monocytosis, an area of unmet medical need
Ivan Bergstein, M.D., CEO of Stemline, commented "The ELZONRIS clinical presentations showcased at ASH (Free ASH Whitepaper) demonstrate a broad clinical potential in a wide range of malignancies. In particular, we believe that our data in relapsed/refractory CMML and MF provides important clinical proof-of-concept in two indications with unmet medical need, and underscores just two of the many potential expansion opportunities that targeting CD123 offers. At ASH (Free ASH Whitepaper), we continued to ramp-up our disease awareness campaign for BPDCN ahead of the upcoming FDA decision on the ELZONRIS BLA. Also, our sales force is prepared and poised to launch ELZONRIS, should approval be obtained. In parallel, our clinical development team is moving forward with plans to expand efforts, including initiating one or more registration-directed trials in indications beyond BPDN, while also continuing to pursue novel entry points in CD123+ acute myeloid leukemia (AML) and other malignancies."

About BPDCN
To learn more about BPDCN, please visit the disease awareness website at www.bpdcninfo.com.

On December 6, 2018 RedHill Biopharma Ltd. (Nasdaq:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, reported the pricing of its previously reported underwritten public offering for a total number of 2,857,143 American Depositary Shares ("ADSs"), each representing ten of its ordinary shares, at a public offering price of $7.00 per ADS (Press release, RedHill Biopharma, DEC 6, 2018, View Source [SID1234531941]).

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Gross proceeds from the sale of the ADSs before underwriting discounts and commissions and other offering expenses are expected to be approximately $20 million. The offering is expected to close on or about December 11, 2018, subject to customary closing conditions. The Company has also granted the underwriters a 30-day option to purchase up to an additional 15% of the number of ADSs offered to the public at the public offering price, less underwriting discount.

Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE American: LTS) and Nomura Securities International, Inc. are acting as joint book-running managers. H.C. Wainwright & Co., LLC is acting as lead manager and LifeSci Capital LLC, Ascendiant Capital Markets, LLC, SMBC Nikko Securities America, Inc. and WBB Securities LLC are acting as co-managers for the offering. Roth Capital Partners is acting as financial advisor to the Company in connection with the offering.

The Company intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to fund preparations for TALICIA (H. pylori) commercial launch and commercialization activities, clinical development programs, including initiation of a pivotal Phase 3 study with RHB-204 for NTM, preparations for a second Phase 3 study with RHB-104 for Crohn’s disease and for acquisitions and general corporate purposes.

The ADSs described above will be issued pursuant to shelf registration statements that were previously filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on March 11, 2016 and July 31, 2018, respectively. A preliminary prospectus supplement and accompanying prospectus related to the offering has been filed with the SEC and is available on the SEC’s website located at www.sec.gov. Before you invest, you should read the preliminary prospectus supplement and accompanying prospectus and other documents we have filed with the SEC for more complete information about us and this offering. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 277 Park Avenue, 26th Floor, New York, New York 10172, by calling (212) 409-2000, or by email at [email protected]; or Nomura Securities International, Inc., Attention: Equity Syndicate Department, Worldwide Plaza, 309 West 49th Street, New York, NY 10019-7316, or by telephone at 212-667-9000, or by email at [email protected].

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

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).