Day: August 6, 2020

Closed strategic licensing agreement with Sobi for SEL-212 for $100 million in initial payments and up to $630 million in potential milestones, and tiered double-digit royaltiesEntered into research license and option agreement with Sarepta for the use of the ImmTOR™ immune tolerance platform in Sarepta’s gene therapy programs in certain neuromuscular diseasesGene therapy program in MMA in collaboration with AskBio on track to enter the clinic in the first half of 2021; preliminary data expected in the second half of 2021Phase 3 clinical program of SEL-212 to commence with Sobi in Q3 2020; on track to report topline data from ongoing head-to-head COMPARE trial in Q3 2020Cash runway into the first quarter of 2023Company to host conference call today at 8:30 a.m. ETWATERTOWN, Mass., Aug. 06, 2020 (GLOBE NEWSWIRE) — Selecta Biosciences,...

IRVINE, Calif., Aug. 06, 2020 (GLOBE NEWSWIRE) — Lantronix, Inc. (the “Company”) (Nasdaq: LTRX), a global provider of secure data access and management solutions for the industrial Internet of Things (IoT), today announced it will release financial results for its fiscal 2020 fourth quarter ended June 30, 2020, on September 10, 2020, after the close of the market.Revised Business OutlookFor the fourth quarter of fiscal 2020, Lantronix expects to report net revenues of $17.1 to $17.6 million, up 4% to 7% sequentially, and up 68% to 73% year over year. The company further expects that GAAP and non-GAAP earnings will grow sequentially from the third quarter of fiscal 2020 and reports that cash grew sequentially to $7.7 million. Due to difficulties in forecasting as a result of supply chain disruptions related to the COVID-19 pandemic,...

Revenues were $2.0 billion in the quarterOperating margin was 2.8%Diluted earnings per share was $1.30Cash from operations was $201 million, and free cash flow1 was $126 millionBacklog of $46.1 billionNEWPORT NEWS, Va., Aug. 06, 2020 (GLOBE NEWSWIRE) — Huntington Ingalls Industries (NYSE:HII) reported second quarter 2020 revenues of $2.0 billion, down 7.4% from the second quarter of 2019. Operating income in the quarter was $57 million and operating margin was 2.8%, compared to $175 million and 8.0%, respectively, in the second quarter of 2019.The decreases in the quarter were primarily driven by unfavorable cumulative catch-up adjustments totaling $167 million resulting from updated cost and schedule assumptions across all programs. This includes $61 million resulting from discrete COVID-19 related delay and disruption estimates...

PETAH TIKVA, Israel, Aug. 06, 2020 (GLOBE NEWSWIRE) — Gilat Satellite Networks Ltd. (NASDAQ, TASE: GILT), a worldwide leader in satellite networking technology, solutions and services, announces the award by a Tier-1 Mobile Network Operator (MNO) in the United States, of a multi-million-dollar service contract for cellular backhaul.The US Tier-1 MNO provides nationwide coverage with its LTE network that is extended with Gilat’s cellular backhaul solution over satellite. Gilat’s solution enables reach to remote areas and ensures high quality service and an excellent user experience. Gilat completed the LTE cellular backhaul satellite migration project according to schedule, during these challenging times imposed by the COVID-19 pandemic.“Gilat is pleased to support the ongoing needs of the Tier-1 MNO and to provide...

New Drug Application for Epsolay® Submitted; Twyneo® New Drug Application on track for 2H 2020Top-line generic product revenue of $1.1 million in 2Q 2020Launch of additional generic product expected in 2Q 2021NESS ZIONA, Israel, Aug. 06, 2020 (GLOBE NEWSWIRE) — Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced financial results for the second quarter ended June 30, 2020 and provided clinical and regulatory updates on its programs.“The second quarter had major milestones for Sol-Gel, as we submitted our first NDA for Epsolay for the treatment of papulopustular rosacea,” commented Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “We look forward to...

SHANGHAI, China, Aug. 06, 2020 (GLOBE NEWSWIRE) — GDS Holdings Limited (“GDS Holdings,” “GDS” or the “Company”) (NASDAQ: GDS), a leading developer and operator of high-performance data centers in China, today announced that it held its Annual General Meeting of Shareholders (“2020 AGM”) on August 6, 2020. Each of the ordinary resolutions submitted to the shareholders for approval at the 2020 AGM has been approved.Specifically, the shareholders of the Company passed ordinary resolutions approving:Re-election of Mr. Gary J. Wojtaszek as a director of the Company;Re-election of Mr. Satoshi Okada as a director of the Company;Confirmation of the appointment of KPMG Huazhen LLP as independent auditor of the Company for the fiscal year ending December 31, 2020;Amendment to Section 3(a) of the 2016 Equity Incentive Plan of the Company (the...

SALT LAKE CITY, Aug. 06, 2020 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced that it will hold its fiscal fourth-quarter 2020 sales and earnings conference call with investors and analysts at 4:30 p.m. EDT on Thursday, August 13, 2020.  During the call, R. Bryan Riggsbee, interim president and CEO and chief financial officer, and Scott Gleason, senior vice president of Investor Relations and Corporate Strategy, will provide an overview of Myriad’s financial performance for the fiscal fourth-quarter and provide a business update. To listen to the earnings call, interested parties in the United States may dial 1-800-381-7839 or +1-212-239-2905 for international callers.  All callers will be asked to reference reservation number 21966478.  The conference...

RESOLVE-1 Phase 3 study of lenabasum for treatment of systemic sclerosis on schedule for topline data this summerPhase 2b study of lenabasum for cystic fibrosis topline results on schedule in Q3 2020Balance sheet strengthened with up to $121M in new capitalCompany to host conference call and webcast today, August 6, 2020 at 8:30 a.m. ETNorwood, MA, Aug. 06, 2020 (GLOBE NEWSWIRE) — Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical-stage drug development company pioneering transformative medicines that target the endocannabinoid system, today reported financial results for the second quarter of 2020. The Company also provided clinical and corporate updates.“We had a busy second quarter as we prepare for a potentially transformative second half of the year with two expected data readouts,...

NEWTOWN, Pa., Aug. 06, 2020 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that it has submitted a request to the U.S. Food and Drug Administration (“FDA”) for de novo classification and clearance of the Portable Neuromodulation Stimulator (PoNSTM) device and reported preliminary financial results for the second quarter and six months ended June 30, 2020. The PoNS device was granted Breakthrough Designation by FDA on May 7, 2020.“Helius is excited to announce the submission of our request for de novo classification and clearance of the PoNS device for the treatment of gait deficit due to symptoms from Multiple Sclerosis (“MS”), to be used as an adjunct to a supervised therapeutic exercise program in patients...

AMRYT ANNOUNCES Q2 2020 RESULTS AND ISSUES POSITIVE REVENUE GUIDANCE FOR FY 2020New revenue guidance of $170M – $175M in 2020Conference call and webcast today 0830 ET / 1330 BSTDUBLIN, Ireland, and Boston MA, August 6, 2020, Amryt (Nasdaq: AMYT, AIM: AMYT, Euronext Growth: AYP), a global, commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases, today announces unaudited financial results and provides a business update for the second quarter ended June 30, 2020.22% YoY growth in unaudited Q2 revenues to $46.2M (Q2 20191 unaudited combined revenues: $37.9M) 26% YoY increase in unaudited H1 revenues to $90.8M (H1 20191 unaudited combined revenues: $72.3M)4% QoQ unaudited revenue growth in Q2  versus Q1 ($44.6M)....