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Mirum Pharmaceuticals Provides Third Quarter 2020 Financial Results and Business Update, and Announces Virtual Investor Day

– Initiated rolling NDA submission and launched Expanded Access Program for maralixibat in Alagille syndrome.

– Presented five-year transplant-free survival data for patients with PFIC2 at Digital International Liver Congress (EASL).

– European Marketing Authorization Application submission for maralixibat in PFIC2, planned by year-end 2020.

– Cash, cash equivalents and investments of $133.7 million.

FOSTER CITY, Calif.–(BUSINESS WIRE)–
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases, today announced financial results and a corporate update for the quarter ended September 30, 2020.

“This quarter marked several milestones toward providing better treatment options for Alagille syndrome and PFIC, with the initiation of our rolling NDA submission, the launch of an expanded access program, and presentation of five-year transplant free survival data in PFIC2,” said Chris Peetz, president and chief executive officer of Mirum. “Looking forward to next year, we are planning for the U.S. launch of maralixibat in Alagille syndrome and the expansion of our programs, with upcoming study starts in biliary atresia, primary sclerosing cholangitis and intrahepatic cholestasis of pregnancy, all settings with high disease burden and no currently approved therapies.”

Key Operational Highlights

• Presented five-year transplant-free survival data for patients with PFIC2 at Digital International Liver Congress (EASL).
• Initiated rolling submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for maralixibat for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).
• Launched maralixibat Expanded Access Program (EAP) for the treatment of cholestatic pruritus associated with ALGS in United States, Canada, Australia, and 10 countries in Europe.
• Announced partnership with EVERSANA™ to support the planned launch and commercialization of maralixibat in ALGS in the United States, if approved.
• Received Orphan Drug Designation from the U.S. FDA for maralixibat in biliary atresia; Phase 2 study initiation planned for the first quarter of 2021.
• Received rare pediatric disease designation for maralixibat for the treatment of PFIC.

Third Quarter 2020 Financial Results

• Total operating expenses for the quarter ended September 30, 2020 were $21.7 million, compared to $15.9 million for the third quarter of 2019.
  • Research and development expenses were $16.0 million, compared to $12.2 million for the comparable prior-year period. This increase was primarily due to increased personnel related expenses, manufacturing activities to support Mirum’s NDA, and higher consulting expenses.
  • General and administrative expenses were $5.7 million, compared to $3.7 million for the comparable prior-year period. The increase was primarily due to personnel and other compensation related expenses.
• For the quarter ended September 30, 2020, Mirum reported a net loss of $21.5 million, or $0.86 per share, compared with a net loss of $15.1 million, or $0.84 per share for the same period in 2019.
• As of September 30, 2020, Mirum had cash, cash equivalents and investments of $133.7 million.

Upcoming Anticipated Milestones

• Corporate
  • Data from the maralixibat and volixibat studies, including long-term maralixibat data (up to 220 weeks) for the treatment of patients with ALGS, to be presented at The Liver Meeting Digital Experience™ (AASLD), November 13-17, 2020.
  • Hosting inaugural Investor Day on December 9, 2020. Additional details below.
• Regulatory
  • Complete rolling NDA submission to FDA for treatment of cholestatic pruritus in patients with ALGS in the first quarter 2021.
  • Marketing Authorization Application submission to European regulators for maralixibat in the treatment of patients with PFIC2 by the end of 2020.
• Pipeline
  • Maralixibat:
    • Phase 2 study initiation planned for biliary atresia by first quarter 2021.
    • Completion of enrollment for MARCH PFIC study anticipated in second quarter 2021.
  • Volixibat:
    • Presenting dose-ranging data at AASLD to inform regimens for potentially pivotal studies in adult cholestasis.
    • Phase 2 study in primary sclerosing cholangitis planned for first quarter 2021.
    • Phase 2 study in intrahepatic cholestasis of pregnancy planned for first quarter 2021.

Investor Day – December 9, 2020

Mirum will be hosting its inaugural Investor Day to highlight Mirum’s pipeline progress and commercial plans to bring potentially transformational new treatments to patients with cholestatic liver diseases. The virtual event will take place on December 9, 2020 at 11:00 a.m. ET. Additional information will be provided closer to the event date.

AASLD – The Liver Meeting Digital Experience™ 2020

New data from maralixibat and volixibat studies will be presented at The Liver Meeting Digital Experience, the annual meeting of the American Association for the Study of Liver Diseases, taking place November 13-17, 2020. Featured presentations to include the following abstracts:

Late-breaker Oral Presentation

L05: Preliminary Analysis of ITCH and IMAGINE II – Outcome of long-term administration of maralixibat in children with Alagille syndrome

• Presented by Benjamin Shneider, M.D. on November 15, 2020 during the 5:30-7:00 p.m. ET session. View the abstract.

Poster Presentations

Abstract #1221: A Phase 1 dose-ranging study assessing fecal bile acid excretion by volixibat, an apical sodium-dependent bile acid transporter inhibitor, and coadministration with loperamide

Abstract #341: Pruritus intensity is associated with cholestasis biomarkers and quality of life measures after maralixibat treatment in children with Alagille syndrome

Abstract #1792: Natural variability of pruritus in Alagille syndrome; an analysis from the ICONIC study utilizing the Itch Reported Outcome Observer (ItchRO[Obs]) tool

All posters will be available at the start of the congress on November 13, 2020 and available throughout the duration of the meeting. Abstracts are available via Hepatology on the AASLD website.

About Maralixibat

Maralixibat is a novel, minimally absorbed, orally administered investigational drug being evaluated in several rare cholestatic liver diseases. Maralixibat inhibits the apical sodium dependent bile acid transporter, resulting in more bile acids being excreted in the feces, leading to lower levels of bile acids systemically, thereby potentially reducing bile acid mediated liver damage and related effects and complications. More than 1,600 individuals have received maralixibat, including more than 120 children who have received maralixibat as an investigational treatment for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC). In the ICONIC Phase 2b ALGS clinical trial, patients taking maralixibat had significant reductions in bile acids and pruritus compared to placebo. In a Phase 2 PFIC study, a genetically defined subset of BSEP (bile salt export pump) deficient (PFIC2), patients responded to maralixibat. The FDA has granted maralixibat Breakthrough Therapy designation for pruritus associated with ALGS in patients one year of age and older and for PFIC2. Maralixibat was generally well-tolerated throughout the studies. The most frequent adverse events were diarrhea and abdominal pain. For more information about the Maralixibat Expanded Access Program please visit ALGSEAP.com. For more information about the Phase 3 study for maralixibat in pediatric patients with PFIC, visit PFICtrial.com.

About Mirum Pharmaceuticals

Mirum Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases. The company’s lead product candidate, maralixibat, is an investigational oral drug in development for Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), and biliary atresia. The company is also developing volixibat, also an oral ASBT-inhibitor, in primary sclerosing cholangitis and intrahepatic cholestasis of pregnancy. For more information, visit MirumPharma.com. Follow Mirum on Twitter, Facebook and LinkedIn.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the results, conduct, progress and timing of Mirum’s ongoing and planned studies for maralixibat and volixibat, the regulatory approval path for maralixibat and volixibat, the strength of Mirum’s balance sheet and the adequacy of cash, cash equivalents and investments on hand, the impacts of the COVID-19 pandemic, and commercial readiness activities. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans,” “will”, “anticipates,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Mirum’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Mirum’s business in general, the impact of the COVID-19 pandemic, and the other risks described in Mirum’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Mirum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Mirum Pharmaceuticals, Inc.
Condensed Consolidated Statement of Operations Data
(in thousands, except share and per share amounts)
(Unaudited)
							Three Months Ended								Nine Months Ended
							September 30,								September 30,
							2020				2019				2020				2019
Operating expenses:
Research and development							$	15,984			$	12,159			$	51,879			$	28,611
General and administrative								5,732				3,708				15,466				7,474
Total operating expenses (1)								21,716				15,867				67,345				36,085
Loss from operations								(21,716	)			(15,867	)			(67,345	)			(36,085	)
Interest income								237				785				1,391				1,485
Other income (expense), net								(30	)			(5	)			(109	)			(1	)
Net loss before provision for income taxes								(21,509	)			(15,087	)			(66,063	)			(34,601	)
Provision for (benefit from) income taxes								(3	)			–				4				–
Net loss							$	(21,506	)		$	(15,087	)		$	(66,067	)		$	(34,601	)
Net loss per share, basic and diluted							$	(0.86	)		$	(0.84	)		$	(2.65	)		$	(4.47	)
Weighted-average shares of common stock outstanding, basic and diluted
								25,132,916				17,996,065				24,965,178				7,745,241
(1) Amounts include stock-based compensation expense as follows:
Research and development							$	1,361			$	830			$	3,662			$	1,539
General and administrative								2,067				1,314				5,313				2,464
Total stock-based compensation							$	3,428			$	2,144			$	8,975			$	4,003
Mirum Pharmaceuticals, Inc.
Selected Condensed Consolidated Balance Sheet Data
(in thousands)
							September 30,				December 31,
							2020				2019
							(Unaudited)
Cash, cash equivalents and investments							$	133,749			$	139,952
Working capital								119,359				106,287
Total assets								141,865				146,712
Accumulated deficit								(135,968	)			(69,901	)
Total stockholders’ equity								120,255				130,349

 

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Investor Contact:

Ian Clements, Ph.D.

[email protected]

Media Contact:

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SMITHS DETECTION EXPANDS IONSCAN™ 600 CAPABILITIES TO DETECT SPICE

EDGEWOOD, Md.–(BUSINESS WIRE)–
Smiths Detection, a leading threat detection and security technology company, announces that it has developed the capability to detect synthetic cannabinoids, commonly known as Spice or K2, with its IONSCAN 600 trace detection solution.

This development comes following an extensive R&D process and testing trials with major correctional institutions around the world and expands the IONSCAN 600 existing detection library of explosives and a wide range of narcotics, including various forms of fentanyl, cocaine, heroin, methamphetamine, and THC. The IONSCAN 600 is also highly effective in finding narcotics that are concealed, such as those that have been liquefied and absorbed in paper.

Spice is an emerging threat for law enforcement officials in prisons, jails, and other secure government facilities. These potent substances can cause life threatening health effects when consumed and pose detection challenges during conventional security screening.

This development is the latest from Smiths Detection who have invested heavily into the critical infrastructure market – which includes law enforcement, emergency responders, and security – to build a comprehensive portfolio of chemical, biological, radiological, nuclear, and explosive (CBRNE) detection and identification solutions.

Philo Daniel, Global Director of Urban Security at Smiths Detection commented, “We are very pleased by the release of this new detection capability. This new library has received a significant level of R&D investment and underwent extensive testing to ensure our customers have the very best information available to them to make critical decisions that protect public health, safety, and security.”

About the IONSCAN 600

The IONSCAN 600 is a portable, trace detector used around the globe at airports, ports and borders, prisons and defence facilities to accurately detect and identify a wide range of military, commercial and homemade explosives threats; and common illegal/controlled narcotics.

About Smiths Detection

Smiths Detection, part of Smiths Group, is a global leader in threat detection and screening technologies for aviation, ports and borders, defence and urban security markets. Our experience and history across more than 40 years at the frontline, enables us to deliver the solutions needed to protect society from the threat and illegal passage of explosives, prohibited weapons, contraband, toxic chemicals and narcotics.

Our goal is simple – to provide security, peace of mind and freedom of movement upon which the world depends.

For more information visit http://www.smithsdetection.com/

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FTI Consulting, Tom Hufton/Georgina Reeves, [email protected], +44 (0)20 3727 1000

Smiths Detection, Sophie Mills, Global Communications Manager, [email protected], + 44 (0)7384236474

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Upwork Appoints Anilu Vazquez-Ubarri to Board of Directors

Experienced Human Resources Executive and Diversity, Equity, & Inclusion Expert to Join Board of Directors of the World’s Largest Work Marketplace

SANTA CLARA, Calif.–(BUSINESS WIRE)–Upwork (NASDAQ: UPWK), the world’s largest work marketplace, today announced the appointment of Anilu Vazquez-Ubarri to its Board of Directors.

Vazquez-Ubarri currently serves as a Partner and Chief Human Resources Officer of TPG, a leading global alternative asset firm. She is also a member of TPG’s Executive Committee. In her role at TPG, Vazquez-Ubarri oversees the firm’s Human Resources function and provides support and counsel to executives across TPG’s portfolio of more than 200 companies.

Prior to joining TPG in 2018, Vazquez-Ubarri spent 11 years at the Goldman Sachs Group, Inc., serving in a variety of roles, most recently as Chief Diversity Officer and Global Head of Talent. Before Goldman Sachs, Vazquez-Ubarri was an associate in the executive compensation and employee benefits group at Shearman & Sterling LLP. She holds a J.D. from Fordham University School of Law and an A.B. cum laude in History and Latin American studies from Princeton University.

“We are extremely pleased to welcome Anilu to Upwork’s Board of Directors,” said Hayden Brown, Upwork’s President and Chief Executive Officer. “Her extensive accomplishments as a strategic HR executive along with her well-established work in diversity, equity, and inclusion will have a significant positive impact on Upwork as we continue to help our customers discover a transformational new way of working. At Upwork we envision a future in which independent talent works at the heart of every business, and we are excited about the contributions Anilu will make to ensuring that vision becomes a reality.”

“I am honored to be joining Upwork’s Board of Directors. As the pioneer of the work marketplace space, Upwork is truly a visionary company driving the new world of work forward,” said Vazquez-Ubarri. “I’m inspired by the company’s mission of creating economic opportunities so people have better lives, and I look forward to working with the leadership team and the Board to continue to expand the reach and impact of Upwork.”

Vazquez-Ubarri is an expert and prominent voice on both human resources and diversity, equity, and inclusion issues. She has been named one of the Most Powerful Latinas in Business by Forbes Magazine and was listed as one of the Top 100 Most Influential Latinas in 2020 by Latino Leaders. The Association of Latino Professionals For America also recently recognized Vazquez-Ubarri as one of the best Corporate Culture Developers in their 2020 50 Most Powerful Latinas list. Vazquez-Ubarri sits on the Board of Directors for the LatinoJustice PRLDEF, a national civil rights organization aimed at creating a more just society by changing discriminatory practices and fostering leadership through advocacy, litigation, and education. In addition, she sits on the Boards of Teach for America-Bay Area, The Vera Institute of Justice, and the Fordham University School of Law Alumni Board.

About Upwork

Upwork is the world’s largest work marketplace, connecting millions of businesses with independent talent around the globe. We serve everyone from one-person startups to 30% of the Fortune 100 with a powerful, trust-driven platform that enables companies and freelancers to work together in new ways that unlock their potential. Our talent community earned over $2 billion on Upwork in 2019 across more than 8,000 skills, including website & app development, creative & design, customer support, finance & accounting, consulting, and operations. Learn more at www.upwork.com and join us on LinkedIn, Twitter, and Facebook.

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Amanda Diamondstein

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Five9 Announces Joint Customer, ProSites, is Utilizing UC Integration With Microsoft Teams

SAN RAMON, Calif.–(BUSINESS WIRE)–
Five9, Inc (NASDAQ: FIVN) an industry-leading provider of the intelligent cloud contact center, today demonstrates continued collaboration with Microsoft as it expands new customer wins using the Five9 UC integration with Microsoft Teams. The latest customer, ProSites, a provider of online marketing solutions for dental, medical and accounting professionals, is using the integration. ProSites is actively using the Five9 Intelligent Cloud Contact Center to power unified voice and digital communications alongside Teams to help it provide real-time sales and support for new and existing clients.

The Five9 integration with Teams increases first call resolution and improves customer experiences by reducing silos between agents and subject matter experts enabling agents to easily locate, contact, and transfer to back-office experts.

ProSites selected the Five9 Intelligent Cloud Contact Center platform to move from their existing on-premise solution to a modern, multi-cloud architecture with innovative capabilities – such as Agent Assist, workflow automation, and virtual assistants. Five9 made migrating to the cloud easy, working with ProSites to not only optimize their call center operations but quickly deploying differentiated features to engage across channels with both prospects and existing customers.

Historically, when ProSites wanted to engage subject matter experts and account managers outside of the traditional contact center in a customer call, agents would manually look for experts who were available to speak – resulting in longer customer call times. The Five9 integration with Teams helped address this delay in service, making it easy for agents to see the availability of experts outside the contact center and include them in customer and prospect conversations immediately.

“With the Five9 integration with Microsoft Teams, we were able to put our customers and prospects in touch with our subject matter experts and account managers immediately; directly enhancing the overall customer experience,” said Keith Washington, VP of Products, ProSites. “We’ve been able to spend less time searching for the right expert and refocus our attention to providing the right answers to customers real-time.”

“Five9 is proud to see our unique Direct Routing for Microsoft Teams, as well as Agent-Expert Consultation for Teams, in action with many of our customers so quickly since we launched,” said Anand Chandrasekaran, EVP of Product Management and Design, Five9. “Today’s consumer expectations are higher than ever, and they expect to have their questions answered in a quick and efficient manner. This timely integration allows businesses to leverage all of its knowledge and come together as a team to provide the best customer experience during a critical period.”

For more information about UC Integration with Teams, please visit Five9 UC Integration or contact your Five9 sales or partner manager.

About Five9

Five9 is a leading provider of cloud contact center software for the intelligent contact center space, bringing the power of cloud innovation to customers and facilitating more than six billion call minutes annually. Five9 provides end-to-end solutions with omnichannel routing, analytics, WFO and AI to increase agent productivity and deliver tangible business results. The Five9 Genius platform is reliable, secure, compliant and scalable; designed to create exceptional, personalized customer experiences. 

For more information, visit www.five9.com.

Engage with us @Five9,LinkedIn,Facebook, Blog, That’s Genius Podcast.

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Latest Mabinogi Update Delivers Amazing Rewards to Help Milletians Advance in the World of Erinn

New Dungeon System and Various Boost Events Available for a Limited Time

LOS ANGELES–(BUSINESS WIRE)–Mabinogi, Nexon’s free-to-play fantasy MMORPG, today announced its latest update bringing various limited-time events to help Milletians earn an abundance of rewards and help them advance in the world of Erinn starting today.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201112005043/en/

The update adds a new, permanent Dungeon Guide System to escort players through the mystifying subterranean chambers, providing information about the major dungeons in Erinn with recommendations based on players’ physical and magical attacks. The system also comes with a guaranteed reward system to compensate players with some core rewards for their repeated efforts. There is even a new special shop with tons of useful items for players to exchange with the vouchers they can now earn through clearing the dungeons.

Now through December 10, players can also perform quests during the Generation Boost Event to earn a variety of rewards, including Erg level 35 catalyst, reforging tools, gems, pets, outfits, trade unlock potion and much more! Milletians will also receive a limited-time first title with strong stats that can further be upgraded. Players are encouraged to login as early as possible to enjoy the boosts longer. Completing G19-G24 is now easier and will also result in more grand rewards. Rewards will also be available to those who previously completed G19-G24.

As a bonus, Mabinogi is also bringing back the Dungeon Drop Rate Increase Event through December 17. During the event period, players will enjoy an increase in drop rates for some of Uladh’s rarest items. Entering Uladh Dungeons with up to seven friends will also now be available permanently.

Starting December 3, even more events, buffs and rewards will be added to help all Mabinogi players, whether active, returning or new, advance even further as they login to the game this Winter.

For more information on Mabinogi’s November update, visit the official website and follow @mabinogion Facebook for the latest updates.

Assets: [Mabinogi] November Update Key Art

Social Media: Facebook / Twitter / Instagram / Twitch / YouTube / Discord

About Mabinogihttps://mabinogi.nexon.net/

Released in 2008, Mabinogi is an immersive free-to-play MMORPG world where mystical adventures await. Create anime-inspired heroes with thousands of customization options, such as hairstyles, facial features and outfits. Select from dozens of talents ranging from professional gunslingers and archers to musicians, tailors and cooks. Players can enjoy the game on their own terms, taking the perilous path of an adventurer or build a thriving business using unique trade skills.

About Nexon America Inc.https://www.nexon.com

Founded in 2005, Nexon America Inc. delivers outstanding free-to-play online game expertise and live game support, taking the strengths of NEXON Co., Ltd. (“Nexon”) and applying them for uniquely western audiences. Nexon America has consistently sustained iconic franchises such as MapleStory and Mabinogi for more than a decade, which have gone on to break records and captivate players. With new projects on the horizon, Nexon America maintains the pioneering and innovative spirit of its parent company, employing its player-first approach, while designing the best possible gameplay experiences for the western market.

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Nexon America

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Mabinogi (Graphic: Business Wire)