Damian Lillard (Portland Trail Blazers) with a deep 3 vs the Oklahoma City Thunder, 01/25/2021
Damian Lillard (Portland Trail Blazers) with a deep 3 vs the Oklahoma City Thunder, 01/25/2021
Germany is the top target of Russian disinformation campaigns in the European Union, a report said on Tuesday, as ties between Moscow and the West hit new lows over the poisoning and jailing of Kremlin critic Alexei Navalny. The EU's disinformation watchdog, which is run by the bloc's External Action Service, said in the report it had documented 700 cases of deliberately fake or misleading reporting that aimed to spread disinformation about Germany since launching a tracking database in late 2015.
REinvent International Sales has closed a raft of deals across its slate of family movies, including “A Christmas Tale,” “Twigson and the Sea Monster” and “Nelly Rapp – Monster Detective.” “Nelly Rapp – Monster Detective,” directed by Amanda Adolfsson, has been sold to the U.S. and Canada (Janson Media), Russia and CIS (Volga Films), Poland […]
The "COVID-19 Diagnostics Market Share, Size, Trends, Industry Analysis Report, By Sample Type; By Product & Service Type; By Test Type; By Mode; By End Use; By Regions; Segment Forecast, 2020-2027" report has been added to ResearchAndMarkets.com's offering.
New Collaboration with Merck Will Evaluate SRF388, Targeting IL-27, in Combination with KEYTRUDA® (pembrolizumab) in Patients with Solid Tumors CAMBRIDGE, Mass., March 09, 2021 (GLOBE NEWSWIRE) -- Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation therapies that target the tumor microenvironment, today reported financial results and corporate highlights for the fourth quarter and full year 2020, as well as anticipated 2021 corporate milestones. “The fourth quarter of 2020 was transformational for Surface. During this quarter, we provided encouraging clinical data from our lead candidates and validated our preclinical discovery capabilities with a second major outlicense agreement that provided the company with substantial financial flexibility for several years,” said Rob Ross, M.D., incoming chief executive officer. “Today, we are also announcing another clinical trial collaboration further enabling rapid assessment of our lead product candidates (in this case SRF388) in combination with pembrolizumab, focusing on patients with liver and kidney cancers. As we look forward into 2021, we are targeting ASCO in June to share additional clinical data on SRF617 and SRF388, and we will work with our partner, GSK, to advance SRF813 into the clinic.” Recent Corporate Highlights: On March 9, 2021, Surface announced a clinical trial collaboration with Merck to evaluate the safety and efficacy of combining Surface’s SRF388, an investigational antibody therapy targeting IL-27, with Merck’s KEYTRUDA® (pembrolizumab), the first anti-PD-1 therapy approved in the United States. This combination will be studied as a component of the first-in-human Phase 1 study of SRF388 and will be evaluated in patients with solid tumors, with a focus on patients with liver cancer and kidney cancer.In December, Surface announced an agreement for GlaxoSmithKline (GSK) to exclusively license worldwide development and commercial rights to Surface Oncology’s preclinical program SRF813, a fully human IgG1 antibody targeting PVRIG (also known as CD112R), an inhibitory protein expressed on natural killer cells (NK cells) and T cells. Under the terms of the agreement, GSK made an $85 million upfront payment in December 2020. In addition, Surface Oncology may receive up to an additional $730 million in future milestone payments, as well as be eligible to receive tiered royalties on global net sales.In November, Surface announced that both of its lead clinical programs, SRF617 (targeting CD39) and SRF388 (targeting IL-27), have achieved predefined criteria for advancement into combination and expansion stages of the ongoing Phase 1 trials. These criteria include acceptable safety profiles at biologically relevant doses, as well as demonstration of target engagement and meaningful pharmacodynamic activity in the ongoing Phase 1 trials.Effective April 1, 2021, Rob Ross, M.D., who has served as chief medical officer at Surface Oncology since 2016, will become the company’s president and chief executive officer and will also be appointed to the board of directors. Rob will succeed current CEO Jeff Goater, who will assume the role of chairman of the Surface Oncology board of directors. Selected Anticipated Near-term Corporate Milestones: Preclinical data presentations for SRF617 and SRF388 at the American Association for Cancer Research (AACR) Virtual Annual Meeting in April.Targeting the American Society of Clinical Oncology (ASCO) Virtual Annual Meeting in June for detailed clinical data presentations for SRF617 and SRF388.Investigational new drug (IND) filing for SRF813 anticipated in 2021. Financial Results: As of December 31, 2020, cash, cash equivalents and marketable securities were $175.1 million, compared to $105.2 million on December 31, 2019. Revenue recognized in the fourth quarter ended December 31, 2020 was $87.6 million, compared to revenue of less than $1.0 million for the same period in 2019. The increase was a result of the $85 million upfront payment received in the fourth quarter 2020 from GSK. Revenue recognized in the full year ended December 31, 2020 was $126.2 million, compared to $15.4 million for the same period in 2019. The increase was a result of the $85 million upfront payment received in the fourth quarter 2020 from GSK, as well as the expiration of the final Novartis option purchase period in January 2020 and the corresponding recognition of the remaining deferred revenue under the agreement. Research and development (R&D) expenses were $10.7 million for the fourth quarter ended December 31, 2020, compared to $11.7 million for the same period in 2019. R&D expenses were $41.0 million for the full year ended December 31, 2020, compared to $52.1 million for the same period in 2019. This decrease was primarily driven by a reduction in expenses associated with contract manufacturing and other IND-enabling activities, as a result of the SRF617 and SRF388 IND filings in 2019, offset by an increase in spend on the SRF617 and SRF388 Phase 1 clinical trials, which began in 2020. R&D expenses included $2.8 million in stock-based compensation expense for the full year ended December 31, 2020. General and administrative (G&A) expenses were $8.9 million for the fourth quarter ended December 31, 2020, compared to $5.1 million for the same period in 2019. G&A expenses were $23.6 million for the full year ended December 31, 2020, compared to $20.6 million for the same period in 2019. This increase was primarily due to increased consulting costs related to the GSK Agreement, as well as increased stock-based compensation expense and bonus achieved in 2020. G&A expenses included $4.9 million in stock-based compensation expense for the full year ended December 31, 2020. For the fourth quarter ended December 31, 2020, net income was $67.3 million, or basic net income per share attributable to common stockholders of $1.66, and diluted net income per share attributable to common stockholders of $1.56. Net loss was $16.0 million for the same period in 2019, or basic and diluted net loss per share attributable to common stockholders of $0.57. For the full year ended December 31, 2020 net income was $59.3 million, or basic net income per share attributable to common stockholders of $1.67, and diluted net income per share attributable to common stockholders of $1.57. Net loss was $54.8 million for the same period in 2019, or basic and diluted net loss per share attributable to common stockholders of $1.97. Financial Outlook: Based upon our current operating plan, Surface continues to project cash runway sufficient through 2023. About Surface Oncology: Surface Oncology is an immuno-oncology company developing next-generation antibody therapies focused on the tumor microenvironment. Its pipeline includes two wholly-owned clinical-stage programs targeting CD39 (SRF617) and IL-27 (SRF388), as well as a preclinical program focused on depleting regulatory T cells via targeting CCR8 (SRF114). In addition, Surface has two partnerships with major pharmaceutical companies: a collaboration with Novartis targeting CD73 (NZV930; Phase 1) and a collaboration with GlaxoSmithKline targeting PVRIG (SRF813; preclinical). Surface’s novel cancer immunotherapies are designed to achieve a clinically meaningful and sustained anti-tumor response and may be used alone or in combination with other therapies. For more information, please visit www.surfaceoncology.com. Cautionary Note Regarding Forward-Looking Statements: Certain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would” or similar expressions, and the negative of those terms. These forward-looking statements are based on Surface Oncology’s management’s current beliefs and assumptions about future events and on information currently available to management. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Surface Oncology’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, risks and uncertainties related to Surface Oncology’s ability to successfully develop SRF388 and SRF617 and its other product candidates through current and future milestones or regulatory filings on the anticipated timeline, if at all, the therapeutic potential of Surface Oncology’s product candidates, the risk that results from preclinical studies or early clinical trials may not be representative of larger clinical trials, the risk that Surface Oncology’s product candidates, including SRF388 and SRF617, will not be successfully developed or commercialized, the risks related to Surface Oncology’s dependence on third-parties in connection with its manufacturing, clinical trials and preclinical studies, and the potential impact of COVID-19 on our clinical and preclinical development timelines and results of operations. Additional risks and uncertainties that could affect Surface Oncology’s future results are included in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2020, which is available on the Security and Exchange Commission’s website at www.sec.gov and Surface Oncology’s website at www.surfaceoncology.com. Additional information on potential risks will be made available in other filings that Surface Oncology makes from time to time with the Securities and Exchange Commission. In addition, any forward-looking statements contained in this press release are based on assumptions that Surface Oncology believes to be reasonable as of this date. Except as required by law, Surface Oncology assumes no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements. Contacts: Investors Matt Lanematt@gilmartinir.com 617-901-7698 MediaGina Nugentgina@tenbridgecommunications.com617-460-3579 Selected Financial Information: (In thousands, except share and per share amounts) (Unaudited) Three months ended December 31, Twelve months ended December 31,Statement of Operations Items2020 2019 2020 2019Collaboration revenue - related party$— $439 $38,592 $15,360 License revenue87,570 — 87,570 — Total revenue87,570 439 126,162 15,360 Operating expenses: Research and development10,728 11,657 41,018 52,118 General and administrative8,872 5,114 23,558 20,608 Total operating expenses19,600 16,771 64,576 72,726 Income (loss) from operations67,970 (16,332) 61,586 (57,366)Interest and other income (expense), net(622) 378 (2,249) 2,577 Net income (loss)$67,348 $(15,954) $59,337 $(54,789)Net income (loss) per share attributable to common stockholders—basic$1.66 $(0.57) $1.67 $(1.97)Weighted average common shares outstanding—basic40,674,996 27,885,539 35,545,121 27,854,912 Net income (loss) per share attributable to common stockholders—diluted$1.56 $(0.57) $1.57 $(1.97)Weighted average common shares outstanding—diluted43,271,667 27,885,539 38,141,793 27,854,912 Selected Balance Sheet Items:December 31, 2020 December 31, 2019Cash, cash equivalents and marketable securities$175,141 $105,161Total assets217,138 131,693Accounts payable and accrued expenses12,122 11,396Deferred revenue – related party— 38,592Total stockholders’ equity155,747 56,666
SEA Electric to Expedite Global Expansion of Proprietary Commercial Electric Vehicle Technology - SEA-Drive(R) SEA Ford F-59 with Sea-Drive 120b This UPS commercial vehicle is a 100% electric SEA Ford F-59 EV, powered by a SEA-Drive® 120b proprietary power-system developed by global automotive technology company SEA Electric. Headquartered in Los Angeles, SEA Electric currently has operations in five countries and more than one million miles of independent Original Equipment Manufacturer (OEM) testing and in-service operations in all markets. SEA-Drive 120b Power-System This UPS commercial vehicle is a 100% electric SEA Ford F-59 EV, powered by a SEA-Drive® 120b proprietary power-system developed by global automotive technology company SEA Electric. Headquartered in Los Angeles, SEA Electric currently has operations in five countries and more than one million miles of independent Original Equipment Manufacturer (OEM) testing and in-service operations in all markets. LOS ANGELES, March 09, 2021 (GLOBE NEWSWIRE) -- Following substantial growth in new markets, global automotive technology company SEA Electric Holdings Pty Ltd. (SEA Electric), announced it has closed initial private placement equity financing for total gross proceeds of approximately US$42 million. The net proceeds from the investment will allow SEA Electric to solidify its position as a market leader in the electrification of commercial vehicles whilst funding its considerable backlog and facilitating more pilot programs with operators. (Please download this press release and HIGH RESOLUTION versions of SEA Electric images and other supporting editorial assets: https://www.dropbox.com/sh/2shmc8051lw62hv/AACViAedt5BIsrAjlI6XAXgha?dl=0 ) With a global headquarters and key leadership in Los Angeles, SEA Electric currently has operations in five countries and more than one million miles of independent Original Equipment Manufacturer (“OEM”) testing and in-service operation in all markets. President and Founder Tony Fairweather stated, “We are very pleased to have completed a heavily oversubscribed equity financing and are excited to welcome aboard a global set of institutional investors as partners. The financing allows SEA Electric to accelerate our sales efforts and grow our backlog as we explore options to seek a public listing in the United States this year.” SEA Electric currently partners with commercial vehicle OEM’s, dealers, operators and upfitters to deliver a new range of zero-emissions trucks and is on schedule to deliver more than 1,000 electric commercial vehicles this year. The company forecast is to have more than 15,000 vehicles on the road by the end of 2023. “2021 will see a paradigm shift in the way developed markets facilitate uptake of commercial electric vehicles and the unstoppable momentum will build year-after-year” said Fairweather. Additionally, Fairweather commented, “We are also very excited to welcome Exro Technologies as a strategic partner and shareholder of SEA Electric. We look forward to expanding our partnership with Exro and helping to optimize the utilization of batteries in a second-life application.” Exro Technologies, a leading Canadian clean technology company and a strategic SEA Electric partner and shareholder, has been known as a pioneer and a real ‘game changer’ when it comes to the power and efficiency of electric motors. According to Fairweather, the collaboration with Exro will focus on utilizing electric truck batteries for energy storage applications. Exro and SEA Electric will co-develop Exro’s Battery Control System (BCS) for operational validation and take the next step toward leadership in power electronics for mobility and energy management. “We’re thrilled to be working together with SEA Electric to increase the momentum of commercial electric vehicle uptake,” said Sue Ozdemir, Chief Executive Officer of Exro Technologies. “We have a strong relationship with Tony and the SEA Electric team and are very excited to realize the benefits of the BCS co-development project.” Working closely with its shareholders, investors and partners including Exro, exclusive financial advisor Eight Capital and international law firm Vinson and Elkins on this financing round, Fairweather confirms the company will also be exploring options to seek a public listing in the United States this year. Background for Series A Round Pursuant to the Financing, SEA Electric issued approximately 1.1 million Series A Preferred Shares at a price of US $40.1995 per share, convertible into common shares of SEA Electric at the option of subscribers and automatically convert to common shares under certain conditions, including SEA Electric completing a public transaction. SEA Electric History Timeline 2012 -- SEA Electric founded in Australia2017 – First SEA Electric model launch after 5 years of product development/field testing,2017 – Launch SEA-Drive® models2018 – (May 2018) Isuzu Australia begin pilot test SEA Electric EV’s2018 – (September 2018) Melbourne factory facility opens2019 – (March 2019) New Zealand facility opens2020 – (January 2020) Los Angeles, California facility opens (Torrance)2020 – (February 2020) Australia grants SEA Electric patent for Commercial EV management system2020 – (May 2020) Staples deploy first SEA Hino 195 EV delivery truck in California2020 – (December 2020) Canada grants SEA Electric patent for Commercial EV management system2020 – (December 2020) Toyota Indonesia signs with SEA Electric to design and build Toyota Innova EV prototype2021 – (May 2021) SEA Electric to launch first SEA Hino Australian SKD assembled EV truck, the SEA Hino 300, at the Brisbane Truck Show About SEA Electric Global automotive technology company SEA Electric was founded in Australia in 2012, creating its proprietary electric power-system technology (known as SEA-Drive®) for the world's urban delivery and distribution fleets. Widely recognized as a market leader in the electrification of commercial vehicles on a global basis, SEA Electric commands a global presence, deploying product in seven countries including USA, Canada, Australia, New Zealand, Thailand, Indonesia and South Africa with collectively more than one million miles of independently OEM-tested and in-service international operation. The company’s global sales, after-sales and engineering are represented in all subsidiaries, whilst North America has the largest upfitting capacity for SEA Electric at more than 30,000 units per annum. Contact: Deb Pollack/Strategic Communications 805.320.9248 Photos accompanying this announcement are available at:https://www.globenewswire.com/NewsRoom/AttachmentNg/ae5c1a9d-0dea-4a99-bb1d-b43ad247afcd https://www.globenewswire.com/NewsRoom/AttachmentNg/4988c02c-661d-4a5a-9a79-ef6cc7936cc8
My love of the Bard doesn't diminish the importance of repairing historic inequities and traumas among my students of color.
While it doesn’t influence our opinions of products, we may receive compensation from partners whose offers appear here. According to a survey done by TD Ameritrade, nearly half of the people polled believe the number one threat to their financial future is the rapidly increasing cost of living. When the cost of living goes up and your financial situation changes significantly, making a budget can make life easier.
DADA earnings call for the period ending December 31, 2020.
The first is from Redfin. The second is from property database keeper ATTOM Data Solutions, which found that home prices rose just as consistently in designated opportunity zones as prices did nationwide.
-- Reloxaliase continues to progress through ongoing pivotal Phase 3 URIROX-2 trial for enteric hyperoxaluria -- -- ALLN-346 poised to enter Phase 1 multiple-ascending dose and Phase 2a trials for hyperuricemia and gout -- -- Management team strengthened with addition of David Clark, M.D., M.R.C.P as Chief Medical Officer and Richard Katz, M.D. as Chief Financial Officer -- NEWTON, Mass., March 09, 2021 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals (NASDAQ:ALNA), a late-stage biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a business update. “Building on the significant accomplishments of 2020, we are entering 2021 well-positioned to execute on our mission of delivering novel oral biologic medicines to patients with rare and serious metabolic and kidney diseases,” said Louis Brenner, M.D, President and Chief Executive Officer of Allena Pharmaceuticals. “We successfully reinvigorated our global Phase 3 URIROX-2 clinical trial of reloxaliase for the treatment of enteric hyperoxaluria, a life-threatening disease for which there is no currently approved therapy. In addition, we initiated clinical development of ALLN-346 for the treatment of hyperuricemia and gout, our second oral biologic program, further demonstrating the potential broad applicability of our technology platform." Dr. Brenner continued, “As a result of the impact of the pandemic on patient enrollment, we now expect to complete the interim analysis in our URIROX-2 trial during the second or third quarter of 2022. Despite the challenges presented by the pandemic, we are grateful for the continued commitment and enthusiasm of our clinical investigators and patients, and are encouraged that both site initiation and recruitment have accelerated significantly in the early months of 2021. With the recent additions to our management team and the available proceeds from financing activities, we are operating from a position of strength, and look forward to delivering reloxaliase as the first potential treatment for patients with enteric hyperoxaluria and advancing ALLN-346 as a potential novel oral agent to treat patients with gout and chronic kidney disease (CKD).” Clinical-Stage Product Candidate Updates Reloxaliase: Novel oral biologic for enteric hyperoxaluria Reloxaliase is a first-in-class, non-absorbed, orally administered enzyme for the treatment of enteric hyperoxaluria. Reloxaliase exerts its effect by breaking down oxalate in the gastrointestinal (GI) tract, reducing the absorption of dietary oxalate. Allena is currently studying reloxaliase in the URIROX-2 trial, the second pivotal Phase 3 clinical trial in its URIROX program, with planned enrollment of 200 patients. The Company plans to conduct an interim analysis after 130 patients have been enrolled in the study for six months, currently expected to occur during the second or third quarter of 2022, with topline data becoming available approximately six months later. The U.S. Food and Drug Administration (FDA) has advised Allena that it agrees with the Company's strategy of pursuing a Biologics License Application (BLA) submission for reloxaliase based upon data from its URIROX program, including the completed URIROX-1 and ongoing URIROX-2 trials, using the accelerated approval regulatory pathway. To support potential accelerated approval, patients will also continue to be followed for a minimum of two years to confirm clinical benefit, including the ability of reloxaliase to reduce the incidence and severity of kidney stone disease and renal impairment. There are currently no approved treatments for enteric hyperoxaluria. ALLN-346: Novel oral biologic for hyperuricemia and gout ALLN-346 is a first-in-class, non-absorbed, orally administered enzyme for the treatment of hyperuricemia and gout. ALLN-346 is designed to exert its effect by breaking down urate in the GI tract, which is expected to lead to a concomitant reduction in urine and serum urate levels. Allena recently completed a Phase 1 single ascending dose study of ALLN-346 in healthy volunteers, which demonstrated no safety or tolerability concerns. In addition, an immunoassay of plasma samples demonstrated that ALLN-346 was not absorbed systemically. A Phase 1 multiple ascending dose study is expected to initiate in the second quarter of 2021, with initial results expected in the third quarter. Additionally, pending feedback from the FDA, a Phase 2a program in patients with hyperuricemia is planned for the second half of 2021, with initial efficacy data expected during the fourth quarter. The Company intends to focus its development program for ALLN-346 on the significant population of patients with hyperuricemia and gout who also suffer from CKD, for whom many of the current therapeutics are either dose-limited or contraindicated due to safety and tolerability concerns. Corporate Update Appointment of David Clark, M.D., M.R.C.P. as Chief Medical Officer In December 2020, Allena announced the appointment of David J. Clark, M.D., M.R.C.P. as Chief Medical Officer. Dr. Clark brings more than 20 years of industry experience to the Company, and has led development programs across multiple therapeutic categories, with an emphasis on immune-mediated and rare diseases. Dr. Clark earned his medical degree from the University of Edinburgh Medical School and conducted a research fellowship in respiratory medicine at the University of Dundee. Appointment of Richard Katz, M.D. as Chief Financial Officer In February 2021, Allena announced the appointment of Richard D. Katz, M.D. as Chief Financial Officer. Dr. Katz also brings more than 20 years of industry experience to the Company, having served as the chief financial officer for several biopharmaceutical companies after beginning his career in the Healthcare Group at Goldman, Sachs & Company. Dr. Katz earned his AB degree from Harvard University, his medical degree from the Stanford University School of Medicine and his MBA from Harvard Business School. Dr. Katz has succeeded Edward Wholihan, whose planned departure was previously announced. Fourth Quarter 2020 Financial Results R&D Expense: R&D expense was $7.0 million for the fourth quarter of 2020, as compared to $8.7 million for the fourth quarter of 2019. The decrease was primarily due to a reduction in costs incurred for the reloxaliase program, including costs for the URIROX-1 and Study 206 trials, both of which were completed during the fourth quarter of 2019, and a reduction in costs incurred for the ALLN-346 program.G&A Expense: G&A expense was $3.0 million for the fourth quarter of 2020, as compared to $2.0 million for the fourth quarter of 2019. The increase was primarily due to increases in stock-based compensation expense and directors' and officers' insurance costs.Net Loss: Primarily reflecting the factors noted above, net loss was $10.3 million for the fourth quarter of 2020, as compared to a net loss of $11.4 million for the fourth quarter of 2019. Cash Position: The cash balance as of December 31, 2020 was $35.0 million. The Company subsequently raised $11.7 million of net proceeds during the first quarter of 2021 through its at-the-market (ATM) equity facility. Additionally, the Company currently has access to up to $15.0 million of convertible debt through its loan and security agreement with Pontifax Medison Finance. Full Year 2020 Financial Results R&D Expense: R&D expense was $20.4 million for the year ended December 31, 2020, as compared to $37.2 million for the year ended December 31, 2019. The decrease was primarily due to a reduction of costs incurred for the reloxaliase program, including costs for the URIROX-1 and Study 206 trials, both of which were completed in the fourth quarter of 2019, and a reduction in costs incurred for the ALLN-346 program, including costs for formulation and development relating to the investigational new drug (IND) application incurred during the third quarter of 2019. The Company filed an IND for ALLN-346 with the FDA in the fourth quarter of 2019.G&A Expense: G&A expense was $11.6 million for the year ended December 31, 2020 as compared to $9.7 million for the year ended December 31, 2019. The increase was primarily due to increases in stock-based compensation expense and directors' and officers' insurance costs.Net Loss: Primarily reflecting the factors noted above, net loss was $32.8 million for the year ended December 31, 2020 as compared to $47.3 million for the year ended December 31, 2019. About Allena Pharmaceuticals Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class, oral biologic therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena’s lead product candidate, reloxaliase, is currently being evaluated in a pivotal Phase 3 clinical program for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders. Allena is also developing ALLN-346 for the treatment of hyperuricemia in the setting of gout and advanced chronic kidney disease, with a Phase 1 multiple-ascending dose study and a Phase 2a program planned for 2021. Forward-Looking Statements This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning the future clinical, regulatory and commercial potential of reloxaliase, statements regarding enrollment and the timing of the planned interim analysis in the URIROX-2 trial, statements regarding Allena’s strategy of pursuing a BLA submission for reloxaliase based upon data from its URIROX program using the accelerated approval regulatory pathway, which strategy is predicated on the FDA’s agreement with our predictive model supporting a relationship between UOx levels and stone formation rates, statements regarding the Allena’s development of ALLN-346 including the timing of planned clinical trials and the announcement of topline date for these trials, and statements regarding Allena’s financial position and need for capital. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: market and other conditions, the timing for completion of Allena’s clinical trials of its product candidates, risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Allena’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risk associated with Allena’s financial condition and its need to obtain additional funding to support its business activities, including the future clinical development of reloxaliase and its ability to continue as a going concern; risks associated with Allena’s dependence on third parties; and risks related to the COVID-19 coronavirus. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Allena’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Item 1A of Part I of Allena’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as discussions of potential risks, uncertainties and other important factors in Allena’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Allena undertakes no duty to update this information unless required by law. Allena Pharmaceuticals, IncSelected Condensed Consolidated Balance Sheet Data(in thousands)(unaudited) As of December 31, 2020 2019Cash and cash equivalents $35,042 $30,007Working capital (1) 31,127 22,127Total assets 38,931 34,108Loan payable, net of current portion and discount 9,853 5,988Total stockholders' equity 22,569 17,198 (1) The Company defines working capital as current assets less current liabilities. See the Company's condensed consolidated financial statements for further detail regarding its current assets and current liabilities. Allena Pharmaceuticals, IncCondensed Consolidated Statements of Operations(in thousands, except share and per share data)(unaudited) For the Three Months Ended December 31, For the Year Ended December 31, 2020 2019 2020 2019 Operating expenses: Research and development$6,977 $8,721 $20,383 $37,244 General and administrative 3,008 1,967 11,603 9,676 Restructuring charges — 605 — 605 Total operating expenses 9,985 11,293 31,986 47,525 Other income (expense), net (273) (66) (859) 186 Net loss$(10,258) $(11,359) $(32,845) $(47,339)Net loss per share attributable to common stockholders—basic and diluted$(0.24) $(0.47) $(1.01) $(2.13)Weighted-average common shares outstanding—basic and diluted 42,004,030 23,497,048 32,506,679 22,180,868 Investor ContactHannah DeresiewiczStern Investor Relations, Inc.email@example.com Media ContactAdam DaleyBerry & Company Public Relations212firstname.lastname@example.org
Committed C$20 million revolving line of credit and C$50 million term loanTargeted at Accelerating Growth and Capacity Expansion InitiativesVancouver, British Columbia--(Newsfile Corp. - March 9, 2021) - The Very Good Food Company Inc. (CSE: VERY) (OTCQB: VRYYF) (FSE: 0SI) ("VERY" or the "Company") is pleased to announce that it has executed a non-binding term sheet (the "Term Sheet") with a prominent institutional lender for a committed C$70 million senior secured Credit Facility (the "Credit ...
VANCOUVER, British Columbia, March 09, 2021 (GLOBE NEWSWIRE) -- ParcelPal Technology Inc. (“ParcelPal” or the “Company”), (OTC:PTNYF) (CSE:PKG) (FSE:PT0) is pleased to announce a pilot agreement with the global leader in selling, marketing and distributing food products to restaurants, healthcare, educational facilities, lodging establishments and other customers who prepare meals away from home. Its family of products also includes equipment and supplies for the foodservice and hospitality industries. We are working with this company’s newly launched “at-home” division that offers a wide range of restaurant-quality food products, including dairy, cut meats, poultry, fresh produce, freezer and pantry staples, in addition to household products and cleaning supplies. With their online grocery delivery, residents can stock-up and elevate their at-home food experience. As part of the pilot program, we are providing delivery services to this new customer in two major cities in Canada. The pilot program will conclude in a few weeks, after the conclusion of which, we hope to expand into additional major cities and territories with this new Company customer. CEO Rich Wheeless stated, “The foodservice area has been a major focus of growth for us and I am very pleased to be working with the global leader in this space. With the successful conclusion to the pilot phase of the program, this should enable us to quickly expand into new markets quickly, and to provide people with the same amazing products they’re accustomed to at home. This is another major milestone for the Company and I am proud of the entire team for being able to get this launched so quickly.” The Company looks forward to providing a further update in the coming weeks. About ParcelPal Technology Inc. ParcelPal is a leader in the growing technology and logistics industry. ParcelPal is a customer-driven, courier and logistics company connecting people and businesses through our network of couriers in cities including Vancouver, Calgary, Toronto and soon in other major cities Canada-wide. Some of our verticals include pharmacy & health, meal kit deliveries, retail, groceries and more. ParcelPal Website: www.parcelpal.com The Canadian Securities Exchange (“CSE”) or any other securities regulatory authority has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release that has been prepared by management. CSE – Symbol: PKGFSE – Symbol: PT0OTC – Symbol: PTNYF Contact: re: Investor Inquiries - email@example.com Forward Looking Information This news release contains forward looking statements relating to the Proposed Transaction, and the future potential of ParcelPal. Forward looking statements are often identified by terms such as "will", "may", "should", “intends”, "anticipates", "expects", “plans” and similar expressions. All statements other than statements of historical fact, included in this release are forward looking statements that involve risks and uncertainties. These risks and uncertainties include, without limitation, the risk that the Proposed Transaction will not be completed due to, among other things, failure to execute definitive documentation, failure to complete satisfactory due diligence, failure to receive the approval of the CSE and the risk that ParcelPal will not be successful due to, among other things, general risks relating to the mobile application industry, failure of ParcelPal to gain market acceptance and potential challenges to the intellectual property utilized in ParcelPal. There can be no assurance that any forward looking statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. The Company cannot guarantee that any forward looking statement will materialize and the reader is cautioned not to place undue reliance on any forward looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward looking statements contained in this news release are expressly qualified by this cautionary statement. The forward looking statements contained in this news release are made as of the date of this news release and the Company will only update or revise publicly any of the included forward looking statements as expressly required by Canadian securities laws.
- Treatment of animal osteosarcoma models with dovitinib increased the median survival time by 50 % as compared to control animals. Press release Hørsholm, Denmark (9 March 2021) – Allarity Therapeutics A/S (“Allarity” or the “Company”) today announced positive data from its preclinical assessment of dovitinib’s antitumor activity in osteosarcoma, the most common primary malignant bone tumor in children and young adults. The purpose of the study was to investigate the capacity of dovitinib alone, and in combination with a specific checkpoint inhibition strategy (anti-PD-1), for slowing the progression of experimental pulmonary metastases in animal models of osteosarcoma. Two separate studies, performed contemporaneously in a syngeneic, mouse model of experimental pulmonary osteosarcoma metastases in mice using the K7M2 cell line, generated the following key results: Treatment with dovitinib, compared to control treatment (sucrose solution lacking dovitinib), increased the median survival time by 50 %.Antitumor growth activity was also observed for dovitinib as a single agent in this model. In addition, it was found that no significant antitumor activity was observed in mice treated with single-agent anti-PD-1 antibody at the investigated dosage and dosing schedule. Furthermore, the combination of dovitinib and anti-PD-1 antibody did not generate additive or synergistic antitumor activities equal or greater than observed by dovitinib alone in the mouse osteosarcoma model. Allarity is preparing for the submission of a new drug application (NDA) for marketing approval, by the U.S. FDA, for dovitinib as a treatment for renal cell carcinoma (RCC). In support of its NDA filing, and in accordance with FDA requirements, the company is also planning a clinical trial in pediatric patients with osteosarcoma, where the patients will be selected with the DRP® companion diagnostic for Dovitinib. The FDA defines pediatric patients as persons aged 21 or younger. Allarity Therapeutics has chosen osteosarcoma as the pediatric indication in which to evaluate the efficacy and safety of dovitinib on the basis of the reported preclinical study. A positive preclinical assessment, as announced today, is a part of the normal prerequisites for initiating a clinical trial in pediatric patients with osteosarcoma. Allarity’s CEO, Steve Carchedi, noted “These data further demonstrates that dovitinib is a therapy that has a potential beyond RCC. We look forward to continuing our work towards regulatory approval of dovitinib, and ultimately realize its potential as a personalized cancer treatment by applying our unique DRP® technology.” M.D., D.Sc., Marie Foegh, CMO of Allarity Therapeutics, further stated. “We are now ready to move forward towards initiating a pediatric clinical trial for dovitinib after receiving these excellent preclinical results. If we can show that dovitinib is also a potential treatment for patients with osteosarcoma, it will further strengthen the case for bringing this new therapy to the market.” 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. About Allarity Therapeutics Allarity 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 advancing towards a U.S. NDA filing 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. Follow us on social media: Facebook: https://www.facebook.com/AllarityTx/ LinkedIn: https://www.linkedin.com/company/allaritytx/ Twitter: https://twitter.com/allaritytx Forward-looking statements This 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. Allarity’s clinical programs may be delayed or impacted by the ongoing global COVID-19 pandemic. ### Investor Contact: Jens Knudsen, CFO +45 8874 2415 Email inquiries: InvestorRelations@allarity.com Media Contact: Thomas Pedersen Carrotize PR & Communications +45 6062 9390 Email inquiries: firstname.lastname@example.org Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Email: email@example.com. Tel: +46 11 32 30 732 This information is information that Allarity A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication on 9 March 2021. Attachment Allarity_Positive Data from Preclinical Dovitinib Study
New York, New York--(Newsfile Corp. - March 9, 2021) - UGE International Ltd. (TSXV: UGE) (the "Company" or "UGE"), a leader in commercial and community solar energy solutions, is pleased to announce that it has signed agreements for the development of solar projects in Maine and Maryland. Together, the projects are expected to have a total rated capacity of 9.0MW DC and a project backlog value of US$18.1 million.The Maine community solar project builds ...
FDA Grants Breakthrough Device Designation for Inivata’s RaDaR™ Assay Designation will help accelerate the regulatory path of RaDaR for use in detection of MRD in early-stage cancer patients Research Triangle Park, NC, USA and Cambridge, UK, 9 March 2021 -- Inivata, a leader in liquid biopsy, today announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its RaDaR™ assay. RaDaR is a personalized assay that tracks a set of up to 48 tumor-specific variants in a patient using a liquid biopsy with exceptional sensitivity. The assay potentially allows detection of residual disease following initial treatment and early detection of relapse. RaDaR is built on Inivata’s proven InVision® liquid biopsy platform technology. This next-generation sequencing platform incorporates built-in controls and error-correction for highly sensitive and specific variant detection. The FDA’s Breakthrough Devices program targets novel medical devices that have the potential to provide patients with a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases and conditions. The program provides patients and healthcare providers with timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards consistent with the FDA’s mission to protect and promote public health. Clive Morris, CEO of Inivata, commented: “Receiving Breakthrough Device Designation is an important milestone for Inivata as we advance the development of our innovative RaDaR liquid biopsy test. Identification of patients with residual disease following initial therapy has the potential to accelerate both the development and future use of therapies for patients with early stage cancers. We look forward to working with the FDA as we move forward with the development of RaDaR.” About InivataInivata is a leader in liquid biopsy. Its InVision® platform unlocks essential genomic information from a simple blood draw to guide and personalize cancer treatment, monitor response and detect relapse. Inivata’s technology is based on pioneering research from the Cancer Research UK Cambridge Institute, University of Cambridge. Its lead product, InVisionFirst®-Lung is commercially available internationally and through NeoGenomics in the US. It offers competitive sensitivity and turnaround, providing molecular insights that enable clinicians to make more informed treatment decisions for advanced NSCLC patients. Inivata has also launched the personalized RaDaR™ assay – allowing the highly sensitive detection of residual disease and recurrence – which has been granted Breakthrough Device Designation by the US FDA. Inivata is partnering with pharmaceutical, biotechnology companies and commercial partners in a range of early and late-stage cancer development programs. The Company has a CLIA certified, CAP accredited laboratory in Research Triangle Park, NC and R&D laboratories in Cambridge, UK. For more information, please go to www.inivata.com. Follow Inivata on Twitter @Inivata. Media Contacts:Consilium Strategic Communications Chris Gardner/Angela Gray/Sarah WilsonAlix Floyd (US) +1 281 433 firstname.lastname@example.org +44 (0)20 3709 5700 Karen Chandler-Smithkaren.email@example.com +44 (0)7900 430235
Allurion Announces Commercial Promotions: Benoit Chardon to CCO, Camillo Docimo to VP Program Excellence and Javier Ibanez to VP International Sales.
Foundation Medicine, Inc. and InformedDNA, the nation’s largest independent provider of genetics services, today announced a collaboration that will enable physicians to refer U.S. patients with possible inherited cancer gene mutations to genetic counseling services and confirmatory genetic testing based on the results of Foundation Medicine’s tumor testing.
Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today announces that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-L201, its investigational gene therapy for the treatment of Leukocyte Adhesion Deficiency-I (LAD-I). RMAT designation was granted based on encouraging preliminary safety and efficacy data from the ongoing Phase 1/2 clinical trial of RP-L201. Additionally, patient enrollment has been fully completed for the Phase 1/2 trial. The study is being conducted at the University of California Los Angeles, University College London (UCL)/Great Ormond Street Children’s Hospital, and Hospital Infantil Universitario Niño Jesús.
Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, announces that President and CEO Michael Nall will participate in three upcoming virtual investment conferences:
SINGAPORE, March 09, 2021 (GLOBE NEWSWIRE) -- Triterras Inc. (Nasdaq: TRIT, TRITW) (“Triterras” or the “Company”), a leading fintech company for trade and trade finance, today announced its partnership with Western Union Business Solutions to provide cross-border payments services between traders and lenders on its Kratos platform. Under this partnership, Western Union Business Solutions’ will offer Kratos users access to fast and reliable technology for the movement of global funds, and expertise in currency risk management. As a leading provider of global payments technology Western Union Business Solutions is a strong complement to Triterras and its blockchain-enabled Kratos platform. “This strategic partnership provides us with an opportunity to reduce our client’s transaction cycle times which will further reduce the borrowing costs of our traders on the Kratos platform,” said Srinivas Koneru, founder, executive chairman and CEO of Triterras. “This partnership is consistent with our overall strategy to continually enhance the value proposition of our Kratos platform to its community of users. The ease of cross-border payments will help make Kratos an even more transformative digital marketplace for trade and trade finance.” Western Union Business Solutions’ innovative online technology and vast financial network help more than 60,000 individuals and businesses manage cross-border payments and currency risk. “We are excited to work with Triterras as a referral partner and provide our leading WU®EDGE platform to its customers. With global settlement capabilities, a commitment to compliance, and expertise in managing currency risk we can help Triterras make cross border payments easy and efficient for its users. This is a significant partnership within our overall strategy to help organisations around the world streamline global payments for their customers,” said Michelle Mak, Head of Sales Asia for Western Union Business Solutions. Triterras operates Kratos, one of the world’s largest commodity trading and trade finance digital marketplaces that connects and enables commodity traders to trade and source capital from lenders directly online. Kratos is the only non-petroleum commodity trade and trade finance blockchain-enabled platform of scale, serving the sub-$10-million-dollar segment. Kratos provides transformational benefits for physical commodity traders and borrowers, solving many key problems by reducing paperwork, mitigating document errors and fraud, and increasing speed, while also providing lower transaction costs, faster cycle times, fraud mitigation, improved counterparty discovery, and higher quality analytics and reporting. For lenders, Kratos cuts administration costs, mitigates risk and the risk of fraud, and provides a marketplace of borrowers who have been subject to bank-grade anti-money laundering and “know-your-customer” checks. About Triterras Triterras is a leading fintech company focused on trade and trade finance. It launched and operates Kratos™—one of the world’s largest commodity trading and trade finance platforms that connects and enables commodity traders to trade and source capital from lenders directly online. For more information, please visit triterras.com or email us at firstname.lastname@example.org. About Western UnionThe Western Union Company (NYSE: WU) is a global leader in cross-border, cross-currency money movement and payments. Western Union’s platform provides seamless cross-border flows and its leading global financial network bridges more than 200 countries and territories and over 130 currencies. We connect businesses, financial institutions, governments, and consumers through one of the world’s widest reaching networks, accessing billions of bank accounts, millions of digital wallets and cards, and over half a million retail locations. Western Union connects the world to bring boundless possibilities within reach. For more information, visit www.westernunion.com. Forward Looking StatementsThis press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Triterras’ actual results may differ from their expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include Triterras’ expectations with respect to future performance. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside Triterras’ control and are difficult to predict. Factors that may cause such differences include but are not limited to risks and uncertainties incorporated by reference under “Risk Factors” in Triterras’ Form 20-F (001-39693) filed with the Securities and Exchange Commission (the “SEC”) on November 16, 2020 (the “Form 20-F”) and in Triterras’ other filings with the SEC. Triterras cautions that the foregoing list of factors is not exclusive. Triterras cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Triterras does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based. Investor Relations Contacts:Jim Groh, Triterras Inc.Mobile: +1 (678) 237-7101Email: IR@triterras.com Gateway Investor RelationsCody Slach and Matt GloverOffice: +1 (949) 574-3860Email: TRIT@gatewayir.com Media Contacts:Gregory PapajohnOffice of Corporate CommunicationsTriterras, Inc.Mobile: +1 (917) 287-3626Email: email@example.com