ON Semiconductor Corporation (Nasdaq: ON), driving energy efficient innovations, today announced it is exploring a sale of its manufacturing facility in Niigata, Japan. The intended sale of Niigata facility is part of the company’s plan to optimize its manufacturing footprint and sharpen its focus on highly differentiated power, analog and sensor products. The company will begin searching for strategic buyers to enter into a mutually beneficial arrangement that is expected to facilitate an orderly transition of products from its facility in Niigata to other facilities in its network.
The Niigata facility is an automotive qualified facility, which meets the IATF 16949 global industry standard for quality management. The company believes that the facility is an attractive semiconductor manufacturing asset. The site is run by a highly skilled and productive workforce capable of managing a large mix of technologies.
The Niigata facility consists of two co-located wafer fabs with 215,000 square feet of clean room space, located on a 40 acre campus with 1.1 million square feet of building space. The large campus, existing infrastructure and capability of eight inch wafer manufacturing provide potential buyers a compelling growth opportunity. Currently, the facility supports the company’s BCD, BiCMOS, CMOS, Discrete and Smart Discrete technologies.
ON Semiconductor remains committed to growing its presence in Japan, and the company recently added a large eight-inch wafer fab in Aizu to its manufacturing footprint. ON Semiconductor plans to continue to invest in its various functional groups, such as field service, research and development, solution engineering centers, and manufacturing plants to better serve its customers in Japan.
About ON Semiconductor
ON Semiconductor (Nasdaq: ON) is driving energy efficient innovations, empowering customers to reduce global energy use. The company is a leading supplier of semiconductor-based solutions, offering a comprehensive portfolio of energy efficient power management, analog, sensors, logic, timing, connectivity, discrete, SoC and custom devices. The company’s products help engineers solve their unique design challenges in automotive, communications, computing, consumer, industrial, medical, aerospace and defense applications. ON Semiconductor operates a responsive, reliable, world-class supply chain and quality program, a robust compliance and ethics program, and a network of manufacturing facilities, sales offices and design centers in key markets throughout North America, Europe and the Asia Pacific regions. For more information, visit https://www.onsemi.com.
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ON Semiconductor and the ON Semiconductor logo are registered trademarks of Semiconductor Components Industries, LLC. All other brand and product names appearing in this document are registered trademarks or trademarks of their respective holders. Although the company references its website in this news release, information on the website is not to be incorporated herein.
This document contains "forward-looking statements,” as that term is defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, included or incorporated in this document could be deemed forward-looking statements, particularly statements about the future financial performance of ON Semiconductor, including financial guidance for the year ending December 31, 2020. Forward-looking statements are often characterized by the use of words such as "believes,” "estimates,” "expects,” "projects,” "may,” "will,” "intends,” "plans” or "anticipates” or by discussions of strategy, plans or intentions. All forward-looking statements in this document are made based on our current expectations, forecasts, estimates and assumptions and involve risks, uncertainties and other factors that could cause results or events to differ materially from those expressed in the forward-looking statements. Among these factors are our revenue and operating performance; economic conditions and markets (including current financial conditions); risks related to our ability to meet our assumptions regarding outlook for revenue and gross margin as a percentage of revenue; effects of exchange rate fluctuations; the cyclical nature of the semiconductor industry; changes in demand for our products; changes in inventories at our customers and distributors; risks associated with restructuring actions and workforce reductions; technological and product development risks; enforcement and protection of our intellectual property rights and related risks; risks related to the security of our information systems and secured network; availability of raw materials, electricity, gas, water and other supply chain uncertainties; our ability to effectively shift production to other facilities when required in order to maintain supply continuity for our customers; variable demand and the aggressive pricing environment for semiconductor products; our ability to successfully manufacture in increasing volumes on a cost-effective basis and with acceptable quality for our current products; risks associated with our acquisitions and dispositions generally, including our ability to realize the anticipated benefits of our acquisitions and dispositions, including our acquisition of Quantenna; risks that acquisitions or dispositions may disrupt our current plans and operations, (including the risk of unexpected costs, charges or expenses resulting from acquisitions or dispositions and difficulties arising from integrating and consolidating acquired businesses, our timely filing of financial information with the Securities and Exchange Commission ("SEC”) for acquired businesses and our ability to accurately predict the future financial performance of acquired businesses); competitor actions, including the adverse impact of competitor product announcements; pricing and gross profit pressures; risks associated with the addition of Huawei Technologies Co., Ltd. and its non-U.S. affiliates and subsidiaries, and other customers, to the U.S. Department of Commerce, Bureau of Industry Security Entity List; loss of key customers; risks associated with restructuring actions and workforce reductions; order cancellations or reduced bookings; changes in manufacturing yields; control of costs and expenses and realization of cost savings and synergies from restructurings; the costs to defend against or pursue litigation and the potential significant costs associated with adverse litigation outcomes; risks associated with decisions to expend cash reserves for various uses in accordance with our capital allocation policy such as debt prepayment, stock repurchases or acquisitions rather than to retain such cash for future needs; risks associated with our substantial leverage and restrictive covenants in our debt agreements that may be in place from time to time; risks associated with our worldwide operations, including changes in trade policies, foreign employment and labor matters associated with unions and collective bargaining arrangements, continuing political unrest in markets in which we do significant business, including Hong Kong, as well as man-made and/or natural disasters and public health and safety outbreaks affecting our operations or financial results, including as a result of the outbreak of the novel coronavirus disease 2019 (COVID-19) pandemic; the threat or occurrence of international armed conflict and terrorist activities both in the United States and internationally; risks of changes in U.S. or international tax rates or legislation; risks and costs associated with increased and new regulation of corporate governance and disclosure standards; risks related to new legal requirements; and risks and expenses involving environmental or other governmental regulation. Additional factors that could affect our future results or events are described under Part I, Item 1A "Risk Factors” in our 2019 Annual Report on Form 10-K filed with the SEC on February 19, 2020 (our "2019 Form 10-K") and from time to time in our other SEC reports. Readers are cautioned not to place undue reliance on forward-looking statements. We assume no obligation to update such information, except as may be required by law. You should carefully consider the trends, risks and uncertainties described in this document, our 2019 Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by this cautionary statement.
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Hørsholm, Denmark (23 October 2020) – Allarity Therapeutics A/S (“Allarity” or the “Company”) today announced several updates related to its planned filing of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for dovitinib, a pan-tyrosine kinase inhibitor (TKI) that is one of Allarity’s priority programs.
The Company is announcing an update on timing for its originally planned first NDA filing for dovitinib as a treatment for renal cell carcinoma (RCC). This NDA is based on non-inferiority to the approved drug sorafenib. The Company’s preparation of the application itself is progressing as scheduled, however the third-party contract manufacturer of the registration batch of the drug is experiencing delays, in part as a result of the ongoing coronavirus pandemic. A registration batch is a mandatory component of the NDA filing. Due to this reported delay, Allarity is now expecting to file the NDA in 2021.
Separately, the Company remains on track to file its first pre-market approval (PMA) application with the U.S. FDA for the use of the dovitinib DRP® companion diagnostic to select and treat likely responders to the drug. If regulatory authorities provide the expected PMA approval of the Dovitinib DRP® and an NDA approval of dovitinib, the Company believes it can make the drug available to DRP®-selected RCC patients as an effective new therapy to treat their disease.
Dovitinib, originally developed by Novartis, addresses a significant unmet need for improved therapies for the treatment of RCC, and is a potential therapeutic alternative to sorafenib. Annual sales of sorafenib, under the trade name Nexavar®, were approximately USD $715 million in 2018. The global RCC market is projected to grow to USD $6.3 billon by 2022. In addition to the RCC market, dovitinib has promising potential as a monotherapy in a number of other indications, including estrogen receptor (ER) positive metastatic breast cancer, hepatocellular cancer, endometrial cancer and gastrointestinal stromal tumors, as well as in combination therapy with other approved drugs, including immune checkpoint inhibitors.
Steve Carchedi, CEO of the Company, noted “Although we are disappointed with the unanticipated contract manufacturing delay for our priority dovitinib program, and the resulting setback of our planned first NDA filing for this promising cancer therapeutic, we recognize the delays are a result of the ongoing coronavirus pandemic that is affecting many facets of our industry. We remain fully committed to advancing the near-term filing of our first dovitinib NDA towards hopeful U.S. approval and to bringing this beneficial cancer therapeutic to RCC patients. Moreover, we are enthusiastic about remaining on track with our planned PMA filing for the Dovitinib DRP® companion diagnostic this year.”
About Allarity TherapeuticsAllarity Therapeutics (Nasdaq First North Growth Market Stockholm: ALLR.ST) develops drugs for personalized treatment of cancer guided by its proprietary drug response predictor technology, the DRP® platform. The company has a mature portfolio of six drug candidates, including compounds in the pre-registration stage. The product portfolio includes: stenoparib (2X-121), a PARP inhibitor in Phase 2 for ovarian cancer; dovitinib, a pan-TKI in post-Phase 3 for renal cell carcinoma; IXEMPRA® (Ixabepilone), a microtubulin inhibitor approved in the U.S. for the treatment of breast cancer; LiPlaCis®, a liposomal formulation of cisplatin in Phase 2 trials for breast and prostate cancer; 2X-111, a liposomal formulation of doxorubicin under manufacturing for Phase 2 in breast cancer; and irofulven, a DNA damaging agent in Phase 2 for prostate cancer.
About the Drug Response Predictor – DRP® Companion Diagnostic
Allarity uses its drug specific DRP® to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, the response rate can be significantly increased. The DRP® method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP® is based on messenger RNA from the patient’s biopsies. DRP® has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP® platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.
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Forward-looking statementsThis announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of Allarity’s control and which could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning Allarity’s plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. Allarity undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.
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Dovitinib Program Updates_Oct 2020
Kopin Corporation (NASDAQ: KOPN), a leading developer and provider of active matrix liquid crystal and organic light emitting diode (OLED) microdisplays and display subassemblies, today announced it has received an approximately $22.9 million order from Leonardo DRS, Inc. (DRS) for its eyepiece assembly which is included in the Family of Weapon Sight-Individual (FWS-I) weapon sight.
FWS-I is a stand-alone, clip-on thermal weapon sight that gives users the ability to acquire targets day or night and in smoke or fog, significantly increasing survivability and lethality margins on the battlefield. This follow-on order has Kopin providing DRS with FWS-I eyepiece assemblies through 2021 as the program ramps up to full-scale production.
"Kopin has been a strong partner supporting our efforts on the FWS-I program,” said Jerry Hathaway, senior vice president and general manager of the Leonardo DRS Electro-Optical Infrared Systems business. "DRS has a long history of supplying the Army with advanced Electro-Optical Infrared technologies, and working with partners like Kopin enables us to equip our soldiers with the best tools to ensure a successful mission,” he said.
"This eyepiece assembly incorporates the very latest advances in our liquid crystal displays together with custom Kopin optics and electronics, packaged in a highly ruggedized assembly designed to withstand the extreme mechanical and thermal stresses of a rifle sight environment,” said Bill Maffucci, Kopin’s Vice President/General Manager of Government and Professional Products, "The unique optical solution within our eyepiece assembly allows it to work in concert with multiple optical rifle scopes as well as in a stand-alone configuration, providing maximum flexibility for the Warfighter. Our demonstrated performance in supplying nearly 300,000 high performance microdisplays and subsystems to multiple generations of thermal weapon sight programs has once again been validated by this order and we look forward to supporting DRS on this and other mission critical programs.”
About Leonardo DRS
Leonardo DRS is a prime contractor, leading technology innovator and supplier of integrated products, services and support to military forces, intelligence agencies and defense contractors worldwide. With over fifty years of experience, its Electro-Optical and Infrared Systems business unit develops and produces industry-leading and trusted sensor technology and integrated solutions for land, sea, air and space systems as well as commercial customers. Headquartered in Arlington, Virginia, Leonardo DRS is a wholly owned subsidiary of Leonardo S.p.A. See the full range of capabilities at www.LeonardoDRS.com and on Twitter @LeonardoDRSnews.
Kopin Corporation is a leading developer and provider of innovative display and optical technologies sold as critical components and subassemblies for military, industrial and consumer products. Kopin's technology portfolio includes ultra-small Active Matrix Liquid Crystal displays (AMLCD), Liquid Crystal on Silicon (LCOS) displays and Organic Light Emitting Diode (OLED) displays, a variety of optics, and low-power ASICs. For more information, please visit Kopin's website at www.kopin.com.
Statements in this press release may be considered "forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act”), which are subject to the safe harbor created by such sections. Words such as "expects,” "believes,” "can,” "will,” "estimates,” and variations of such words and similar expressions, and the negatives thereof, are intended to identify such forward-looking statements. We caution readers not to place undue reliance on any such "forward-looking statements,” which speak only as of the date made, and advise readers that these forward-looking statements are not guarantees of future performance and involve certain risks, uncertainties, estimates, and assumptions by us that are difficult to predict. These forward-looking statements may include statements with respect to: This $22.9 million follow-on order has Kopin providing DRS with FWS-I eyepiece assemblies through 2021 as the program ramps up to full-scale production Various factors, some of which are beyond our control, could cause actual results to differ materially from those expressed in, or implied by, such forward-looking statements. This follow-on order has Termination for Convenience clause which would allow the U.S. government to cancel the order before completion. All such forward-looking statements, whether written or oral, and whether made by us or on our behalf, are expressly qualified by these cautionary statements and any other cautionary statements that may accompany the forward-looking statements. In addition, we disclaim any obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release, except as may otherwise be required by the federal securities laws. These forward-looking statements are only predictions, subject to risks and uncertainties, and actual results could differ materially from those discussed. Important factors that could affect performance and cause results to differ materially from management's expectations are described in Part I, Item 1A. Risk Factors; Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations; and other parts of our Annual Report on Form 10-K for the fiscal year ended December 28, 2019, or as updated from time to time in the Company’s Securities and Exchange Commission filings.
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