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Business News for the United Kingdom and Turkey

A Visual Diary of 365 Days exhibition

From 24 Nov to Dec 5, 2021, The Charing Cross Library will showcase the works of Esra Kizir Gokcen, with a Private View on Friday 26 November 5-8pm. For this exhibition, a…

X-PITCH 2021 Global Winners Announced

TAIPEI, Taiwan–(BUSINESS WIRE)–At the Grand Finale of X-PITCH 2021 held on November 11, TOP150 Semi-finalists — who are selected from 3,680 startups in 42 countries — pitched their business online (for international teams) and in a 60-second autonomous car ride at Hutoushan Innovation Hub of Taoyuan City (for local teams), followed by a 3-minute online pitch in the TOP15 Finals hosted at TutorABC’s T-Space. The TECH FOR GOOD theme of X-PITCH 2021 highlights the challenges in the post-pandemic world, participating teams focus on applications and services that enable digital transformation around five major categories of the New Normal.


Over a thousand people attended the event, which was broadcast live via online platforms including e27, Meet Startup, Startup Island and PitchFlix. The event was also graced by distinguished guests including Ms. Hsu Chia-Ching, Deputy Minister of Overseas Community Affairs Council of ROC (Taiwan); Mr. Cheng Wen-Tsan, Mayor of Taoyuan City; and Mr. Eason Kuo, Director-General of Department of Economic Development of Taoyuan City.

10 startups emerged as winners at the Grand Finale, and the top three startups will receive US$1 million investment in total. The winner list (www.xpitch.io/winners) is as follows:

Startup of the Year – Gold Award: IronYun (United States)

Startup of the Year – Silver Award: Dayta AI (Hong Kong)

Startup of the Year – Bronze Award: Biomdcare (Taiwan)

Best Public Service / Healthcare Startup: Asilla (Japan)

Best Industrial / Supply Chain Startup: Steer (Philippines)

Best Consumer Lifestyle Startup: Business Canvas (Korea)

Best Mobility / Transportation Startup: WeWALK (United Kingdom)

Best Banking / Commerce Startup: MHUB (Malaysia)

Number Pitch – Champion: Pulxion (Taiwan)

Number Pitch – People’s Choice: Ai Aerial Dynamics (India)

TOP15 Startups with Outstanding Performance include Arcare Innova (Taiwan), InfinitiesSoft (Taiwan), KERB (Australia), RE (Taiwan), Riipay (Malaysia), WeavAir (Singapore), Wordcab (Vietnam).

“With the number of participating countries and startups, X-PITCH has become one of the world’s largest startup competitions in its first year and is probably the most challenging one in the contest format, wherein participants went through the 15-second, 60-second and 3-minute pitch to win awards and investments. This X Games for Startups enables founders to revisit their business and tell their story in a more precise way. X-PITCH is also a platform for global startups, investors, corporates, and ecosystem builders to connect with each other. A lot of value-added activities and resources are provided to the participants, some of these include investor & corporate matchmaking program, country access webinars, valuation & fundraising workshops, online exhibitions, and media exposure,” said Kevin Yu, Founding Partner of Taiwan Accelerator (TA), the organizer of X-PITCH 2021.

Special thanks to the event Supervisors National Development Council and Overseas Community Affairs Council; Co-organizers Taoyuan City Government, Block71 Singapore, Born2Global, BSSC, DOST-PCIEERD, Innovation Factory, JETRO, MDEC and VITTBI; Corporate Partners ASUS, Avalue, O-Bank, Pro Long Capital and Yulon Motor; Media Partners e27 and Meet Startup; Venue Partners Hutoushan Innovation Hub and TutorABC’s T-Space; Exhibition Partners InnoVEX and Meet Taipei; Valuation Partner Equidam; PR Partner Amazing Creativity; Design Partner Investec Design; 18 Investment Partners; 130+ Supporting Partners; and Judges Cami Lu (Operating Partner at Sunsino Venture Group), Elisa Chiu (Founder & CEO at Anchor Taiwan), Lewis Chen (Deputy General Director of CIS at ITRI), and Peter Cheng (President of Acom Networks).

At the event, Kevin Yu and managing partners James Ku, Brent Hu and Jason Liu announced the official launch of a new VC accelerator firm – XCEL NEXT (www.xcelnext.vc). With operations in Taipei, Singapore and Silicon Valley, XCEL NEXT’s goal is to invest and accelerate 100 startups in Asia and the world over the next 3 years. TA itself has become a startup system ecosystem connector and event company.

Video replay of the event can be found on X-PITCH website: www.xpitch.io

Contacts

Media:

Eric Hu

media@accelerator.tw

Lee Johnstone’s Volvo P1800 From the UK Crowned Winner of 2021 Hot Wheels™ Legends Tour Global Grand Finale at Jay Leno’s Garage

  • Announced at Jay Leno’s Garage on Nov. 13, the 1969 Volvo P1800 from the United Kingdom will be inducted into the Hot Wheels Garage of Legends™ and immortalized as a 1:64 Hot Wheels® die-cast toy sold around the world
  • Panel of judges consisted of Hot Wheels designers, automotive experts and celebrity car aficionados

EL SEGUNDO, Calif.–(BUSINESS WIRE)–The winner of the 2021 Hot Wheels™ Legends Tour was selected today during a global livestream event at Jay Leno’s Garage. Hailing from Somerset, England, the 1969 Volvo P1800 built by Lee Johnstone will join a prestigious group of custom cars in the Hot Wheels Garage of Legends™ and will be forever immortalized as a 1:64 Hot Wheels® die-cast toy.


This Volvo P1800 “Aint No Saint” Gasser was originally registered as new in 1969. Its owner, 71-year-old English motor mechanic Lee Johnstone, acquired the vehicle as a rusty rolling shell before thoroughly restoring, modifying, and transforming it into the quarter-mile monster it is today. Sporting a Chevrolet 454 big block, its new power plant is capped with a 671 GMC supercharger and dual four-barrel carburetors. Finished in a fitting shade of Volvo green, it is a true culmination of more than 50 years of ‘race it, break it, build it better’ experience. Perhaps most importantly – and in true challenger spirit – “Aint No Saint” is also a family affair, with Lee’s three daughters, Eleanor, Sarah and Victoria, sharing in the driving duties, and his wife, Sue, on standby to help crew.

Finishing its fourth year, the Hot Wheels Legends Tour is a worldwide competition spanning 11 countries and five continents, making it the world’s largest international traveling car show. Thousands of builds were submitted to compete in a series of in-person and virtual stops, which began in April 2021. Over the past seven months, some of the most unique and inspiring custom creations went head-to-head, all for a chance to become the next Hot Wheels die-cast toy sold – and played with by fans of all ages – across the globe.

This year’s global Grand Finale was co-hosted by celebrity car enthusiast Jay Leno and motorsports ambassador Jarod DeAnda during a virtual livestream event, where they were joined by an array of automotive and design experts from around the world to complete the task of choosing the 2021 winner. Joining them on stage were Ted Wu, Global Head of Design for Vehicles, Mattel; Bryan Benedict, Director of Vehicles Design, Mattel; Brendon Vetuskey, Vehicles Designer, Mattel; Henrik Fisker, automotive design icon; Elana Scherr, senior editor of Car and Driver; car customizer and automotive electronics guru Mad Mike; and automotive content creator and drifting enthusiast Sara Choi.

“The Hot Wheels Legends Tour has truly become a global celebration of custom car creations,” said Ted Wu, Vice President, Global Head of Design for Vehicles, Mattel. “With the addition of five new countries in the Tour, we have been able to reach and interact with millions of new fans and builders from around the world. The Volvo Gasser is a wonderful expression of authenticity, creativity and, most importantly, garage spirit. We look forward to welcoming Lee Johnstone and his 1969 Volvo P1800 into the Hot Wheels family and presenting the world with our newest Hot Wheels Legends Tour die-cast toy.”

“Having my family here with me for this moment was so special,” said Lee Johnstone. “I am excited to have my car become a Hot Wheels die-cast toy and to be able to share my passion project in 1:64 scale with the world. It’s amazing to be the first U.K. winner.”

The 2021 Hot Wheels Legends Tour was made possible in collaboration with Walmart and Mobil 1.

To learn more about the Hot Wheels Legends Tour, visit https://hotwheels.mattel.com/explore/en/legends-tour.

ABOUT HOT WHEELS

As a 53-year old brand more relevant today than ever before, Hot Wheels is the world’s leading vehicle franchise which represents and unites all segments of car culture. For decades Hot Wheels has proven its influence in automotive and pop culture with legendary design and epic performance. Through unparalleled collaborations with global leaders in streetwear, fashion, luxury, entertainment, action sports and motorsports, Hot Wheels is the #1 selling toy in the world* with over 8 billion vehicles sold. The brand engages fans of every generation through immersive live events, global competitions, theme park attractions, world-class digital gaming, consumer products and film and television content.

About Mattel

Mattel is a leading global toy company and owner of one of the strongest catalogs of children’s and family entertainment franchises in the world. We create innovative products and experiences that inspire, entertain and develop children through play. We engage consumers through our portfolio of iconic brands, including Barbie®, Hot Wheels®, Fisher-Price®, American Girl®, Thomas & Friends™, UNO® and MEGA®, as well as other popular intellectual properties that we own or license in partnership with global entertainment companies. Our offerings include film and television content, gaming, music and live events. We operate in 35 locations and our products are available in more than 150 countries in collaboration with the world’s leading retail and e-commerce companies. Since its founding in 1945, Mattel is proud to be a trusted partner in empowering children to explore the wonder of childhood and reach their full potential.

About Mobil 1

Mobil 1™ motor oil is the world’s leading brand of synthetic motor oil. Our advanced technology allows Mobil 1 motor oils to meet or exceed some of the industry’s toughest standards and to provide exceptional protection under even extreme driving conditions. Mobil 1 motor oil is designed to help protect critical engine parts, maximize engine performance, and extend engine life. For more information, visit us online at www.mobil1.us or and follow @Mobil1 on Facebook, Instagram and Twitter.

*Source: The NPD Group/Retail Tracking Service

MAT-W

Contacts

Scott Shaffstall
Mattel Global Communications

scott.shaffstall@mattel.com
310-252-3610

Michael Haas
Extension PR

mhaas@extensionpr.com
949-838-4116

Taylor Vande Beek
Extension PR

tvandebeek@extensionpr.com
310-982-0242

LivaNova Comments on Decision by Court of Appeal of Milan

LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, commented on the decision delivered today by the Court of Appeal of Milan (CoA) for LivaNova to pay damages in the amount of €453 million (approximately U.S. $519 million) as a result of a civil action where the CoA declared LivaNova (formed through a merger with Sorin) jointly liable with SNIA (a former parent company of Sorin) for environmental liabilities incurred by SNIA’s other subsidiaries. LivaNova strongly disagrees with the decision and will vigorously pursue all available remedies, including an appeal to the Italian Supreme Court. LivaNova filed an appeal over two years ago with the Italian Supreme Court regarding the CoA’s previous decision on joint liability, though the damages decision may not be stayed pending resolution of the appeal on joint liability by the Italian Supreme Court.

About LivaNova

LivaNova PLC is a global medical technology and innovation company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through innovative medical technologies, delivering life-changing improvements for both the Head and Heart. Headquartered in London, LivaNova employs approximately 3,000 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals and healthcare systems worldwide. For more information, please visit www.livanova.com.

Safe Harbor Statement

This news release contains “forward-looking statements” concerning our goals, beliefs, expectations, strategies, objectives, plans and underlying assumptions and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding legal proceedings, court judgments and actions in response to such litigation. Actual results may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2020, as supplemented by any risk factors contained in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. We undertake no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.

Contacts

LivaNova Investor Relations and Media Contacts
+1 281-895-2382

Lindsey Little
Senior Director, Investor Relations

InvestorRelations@livanova.com
Deanna Wilke
VP, Corporate Communications

Corporate.Communications@livanova.com

S&P Global and IHS Markit Merger Receives Conditional Clearance from the U.S. Department of Justice

NEW YORK & LONDON–(BUSINESS WIRE)–S&P Global (NYSE: SPGI) and IHS Markit (NYSE: INFO) announced today that they have reached a proposed agreement with the Antitrust Division of the U.S. Department of Justice (DOJ) that permits the companies to proceed with their $44 billion combination.

Consistent with the commitments both companies have made to obtain regulatory approval in other jurisdictions, the proposed agreement with the DOJ requires the companies to divest IHS Markit’s Oil Price Information Services (OPIS), Coal, Metals and Mining (CMM), and PetroChem Wire (PCW) businesses. The companies previously announced an agreement to sell these businesses to News Corp. The proposed agreement with the DOJ, which remains subject to court approval, does not require the companies to make any additional divestitures.

Subject to the receipt of remaining regulatory approvals and satisfaction or waiver of specified closing conditions, S&P Global and IHS Markit continue to expect the merger to close in the first quarter of 2022.

Advisors

Goldman Sachs & Co. LLC is serving as financial advisor to S&P Global, and Wachtell, Lipton, Rosen & Katz is serving as legal counsel. Davis Polk & Wardwell LLP is serving as legal counsel for IHS Markit.

About S&P Global

S&P Global (NYSE: SPGI) is the world’s foremost provider of credit ratings, benchmarks and analytics in the global capital and commodity markets, offering ESG solutions, deep data and insights on critical business factors. We’ve been providing essential intelligence that unlocks opportunity, fosters growth and accelerates progress for more than 160 years. Our divisions include S&P Global Ratings, S&P Global Market Intelligence, S&P Dow Jones Indices and S&P Global Platts. For more information, visit www.spglobal.com.

About IHS Markit

IHS Markit (NYSE: INFO) is a world leader in critical information, analytics and solutions for the major industries and markets that drive economies worldwide. The company delivers next-generation information, analytics and solutions to customers in business, finance and government, improving their operational efficiency and providing deep insights that lead to well-informed, confident decisions. IHS Markit has more than 50,000 business and government customers, including 80 percent of the Fortune Global 500 and the world’s leading financial institutions. Headquartered in London, IHS Markit is committed to sustainable, profitable growth.

Forward-Looking Statements:

This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements, which are based on current expectations, estimates and projections about future business and operating results, the industry and markets in which S&P Global Inc. (“S&P Global”) and IHS Markit Ltd. (“IHS Markit”) operate and beliefs of and assumptions made by S&P Global management and IHS Markit management, involve uncertainties that could significantly affect the financial or operating results of S&P Global, IHS Markit or the combined company. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “will, ” “should,” “may,” “projects,” “could,” “would,” “target,” “estimates” or variations of such words and other similar expressions are intended to identify such forward-looking statements, which generally are not historical in nature, but not all forward-looking statements include such identifying words. Such forward-looking statements include, but are not limited to, projections of earnings, statements of plans for future operations or expected revenues, statements about the benefits of the transaction involving S&P Global and IHS Markit, including future financial and operating results and cost and revenue synergies, the combined company’s plans, objectives, expectations and intentions. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future — including statements relating to creating value for shareholders, benefits of the proposed transaction to shareholders, employees, customers and other constituents of the combined company, the outcome of contingencies, future actions by regulators, changes in business strategies and methods of generating revenue, the development and performance of each company’s services and products, integrating our companies, cost savings, the expected timetable for completing the proposed transaction, general conditions in the geographic areas where we operate and our respective effective tax rates, cost structure, dividend policy, cash flows or liquidity — are forward-looking statements.

These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially from those expressed in such forward-looking statements. We can give no assurance that our expectations will be attained and therefore, actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements. For example, these forward-looking statements could be affected by factors including, without limitation, risks associated with: (i) the satisfaction of the conditions precedent to consummation of the proposed merger between S&P Global and IHS Markit and the divesture of the OPIS, CMM and PetroChem Wire businesses, including the ability to secure regulatory approvals on the terms expected, at all or in a timely manner; (ii) uncertainty relating to the impact of the proposed merger and divestiture transaction on the businesses of S&P Global and IHS Markit, including potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed transaction and changes to existing business relationships during the pendency of the acquisition that could affect S&P Global’s and/or IHS Markit’s financial performance; (iii) the ability of S&P Global to successfully integrate IHS Markit’s operations and retain and hire key personnel; (iv) the ability of S&P Global to implement its plans, forecasts and other expectations with respect to IHS Markit’s business after the consummation of the proposed transaction and realize expected synergies; (v) business disruption following the proposed transaction; (vi) economic, financial, political and regulatory conditions, in the United States and elsewhere, and other factors that contribute to uncertainty and volatility, including the United Kingdom’s withdrawal from the European Union, natural and man-made disasters, civil unrest, pandemics (e.g., the coronavirus (COVID-19) pandemic (the “COVID-19 pandemic”)), geopolitical uncertainty, and conditions that may result from legislative, regulatory, trade and policy changes associated with the current U.S. administration; (vii) the ability of S&P Global and IHS Markit to successfully recover from a disaster or other business continuity problem due to a hurricane, flood, earthquake, terrorist attack, war, pandemic, security breach, cyber-attack, power loss, telecommunications failure or other natural or man-made event, including the ability to function remotely during long-term disruptions such as the COVID-19 pandemic; (viii) the impact of public health crises, such as pandemics (including the COVID-19 pandemic) and epidemics and any related company or governmental policies and actions to protect the health and safety of individuals or governmental policies or actions to maintain the functioning of national or global economies and markets, including any quarantine, “shelter in place,” “stay at home,” workforce reduction, social distancing, shut down or similar actions and policies; (ix) the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; (x) changes in debt and equity markets, including credit quality and spreads; (xi) demand for investment products that track indices and assessments, and trading volumes of certain exchange-traded derivatives; (xii) changes in financial markets, capital, credit and commodities markets and interest rates; (xiii) the possibility that the transaction may be more expensive to complete than anticipated, including as a result of unexpected factors or events; (xiv) the parties’ ability to meet expectations regarding the accounting and tax treatments of the proposed transaction; and (xv) those additional risks and factors discussed in reports filed with the Securities and Exchange Commission (the “SEC”) by S&P Global and IHS Markit from time to time, including those discussed under the heading “Risk Factors” in their respective most recently filed Annual Reports on Form 10-K and subsequent Quarterly Reports on Form 10-Q. While the list of factors presented here is considered representative, this list should not be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Consequences of material differences in results as compared with those anticipated in the forward-looking statements could include, among other things, business disruption, operational problems, financial loss, legal liability to third parties and similar risks, any of which could have a material adverse effect on S&P Global’s or IHS Markit’s consolidated financial condition, results of operations, credit rating or liquidity. Except to the extent required by applicable law or regulation, each of S&P Global and IHS Markit disclaims any duty to update any forward-looking statements contained in this communication or to otherwise update any of the above-referenced factors.

Contacts

Investor Relations:


IHS Markit
Eric Boyer

Tel: +1 303 397 2969

eric.boyer@ihsmarkit.com

S&P Global
Chip Merritt

Tel: +1 212 438 4321

chip.merritt@spglobal.com

Media:


IHS Markit
Sebastian Kadritzke

Tel: + 44 203 159 3283

sebastian.kadritzke@ihsmarkit.com

S&P Global
Ola Fadahunsi

Tel: +1 212 438 2296

ola.fadahunsi@spglobal.com

Humanigen Reports Third Quarter and Nine Months Ending September 30, 2021 Financial Results and Provides Corporate Update

BURLINGAME, Calif.–(BUSINESS WIRE)–Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‛cytokine storm’ with its lead drug candidate, lenzilumab, today provided a corporate and regulatory update and reported financial results for the third quarter and nine months ended September 30, 2021.

Status of Application to UK’s Medicines and Healthcare Products Regulatory Agency (MHRA)

On June 11, 2021, Humanigen initiated submission of an application seeking Conditional Marketing Authorization (CMA) from the UK’s MHRA for lenzilumab in hospitalized COVID-19 patients and it was accepted for expedited COVID-related rolling review on July 9, 2021. Humanigen submitted the last of the planned modules on September 30, 2021. The company believes MHRA is actively reviewing its application.

“We are continuing our efforts to get lenzilumab to hospitalized COVID-19 patients. The recent selection of lenzilumab by the European Commission as one of the 10 most promising treatments for COVID-19, validates our view that lenzilumab offers meaningful clinical potential.1 We appreciate the commitment MHRA has made to reviewing our application,” said Cameron Durrant, Chairman and CEO, Humanigen. “The vaccination rate in the UK is 79%, yet hospitalizations due to COVID-19 continue. We continue to work with regulators in the UK, US, and European Union to potentially bring this therapy to patients.”2

Recent data suggests that the protection offered to fully vaccinated individuals from infection and severe disease wanes over time and there is a continued need for additional treatment options for patients who become severely ill after infection with SARS-CoV-2.3 Despite nearly 80% of the population in the UK being fully vaccinated, there were nearly 25,000 COVID-19 patients newly admitted to hospitals for treatment in October, more than 60% of whom were fully vaccinated. 2,4,5

Timothy Morris, COO/CFO, Humanigen, noted, “We are preparing for potential launch in the UK if lenzilumab were to receive authorization from MHRA by securing a supply chain to import, release and distribute lenzilumab to UK hospitals. Separately, our agreement with Clinigen, once fully operational, will allow us to distribute lenzilumab to patients in 16 countries in the EU where regulations allow for managed access, named patient, compassionate use or similar programs. We are also pleased by the progress being made to evaluate lenzilumab in Chronic Myelomonocytic Leukemia (CMML), acute Graft versus Host Disease (aGvHD), and our own effort to conduct a Phase 3 study with commercially-approved CD19 CAR-T therapies in non-Hodgkin lymphoma (NHL).”

Third Quarter and Recent Highlights:

Lenzilumab in hospitalized COVID-19

  • European Commission selected Humanigen’s lenzilumab as one of the 10 most promising treatments for COVID-19.
  • Submitted final required modules as well as a risk management plan and pediatric investigation plan for CMA for lenzilumab in COVID-19 to the UK’s MHRA.
  • EMA appointed a Rapporteur and Co-Rapporteur related to the company’s planned submission of an MAA for lenzilumab in COVID-19 in the EU.
  • Entered into agreement with Clinigen Group to establish a Managed Access Program to enable access to lenzilumab on a case-by-case basis to patients in up to 16 European countries.
  • Requested and granted a Type B meeting with FDA. Included in the briefing materials for the meeting request were day 60 data as well as detailed CRP analysis from the company’s LIVE-AIR Phase 3 study.

Lenzilumab in CMML, aGvHD, and NHL

  • First patient dosed in Phase 2 study of lenzilumab in patients with Chronic Myelomonocytic Leukemia (CMML), sponsored by the company’s Australian partners.
  • Reached agreement with University of Birmingham to conduct a Phase 2/3, potentially registrational, trial to evaluate lenzilumab in the treatment of aGvHD at IMPACT Partnership stem cell transplant centers across the UK.
  • Scheduled a meeting in December 2021 with FDA to discuss a protocol to conduct a Phase 3 randomized, placebo-controlled, open-label trial of lenzilumab to improve the safety and efficacy of CD19 CAR-T therapies in the treatment of NHL.

Corporate

  • Elected John Hohneker, MD, and Kevin Xie, PhD, to Board of Directors.
  • Received U.S. Patent 11,130,805 protecting the method of treating CAR-T cell therapy-induced neurotoxicity using a GM-CSF inhibitor. The patent issued on September 28, 2021 and has an expected patent term through October 2, 2038.

ACTIV-5 Update

In August 2021, the National Institutes of Health (NIH) announced the advancement of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-5) and Big Effect Trial, in the “B” arm of the trial (BET-B), referred to as ACTIV-5/BET-B. Following feedback from and consultation with the company, the NIH advanced the study to a Phase 2/3 study with target enrollment of up to 400 patients with a baseline CRP<150 mg/L, or a total of up to 550 patients, and amended the protocol for ACTIV-5/BET-B in a manner that aligns with the design of the company’s LIVE-AIR trial. The trial is approximately 75% enrolled.

Third Quarter and Nine Months Ended September 30, 2021 Financial Results

Net loss for the three months ended September 30, 2021 was $66.7 million or $1.12 per share as compared to $30.8 million or $0.71 per share for the three months ended September 30, 2020. The net loss for the nine months ended September 30, 2021 was $203.1 million or $3.56 per share as compared to $57.2 million or $1.79 per share for the nine months ended September 30, 2020. The increase in net loss for both periods was largely due to an increase in total expenses, mainly Research and Development (“R&D”) expense which rose significantly as the company accelerated its efforts to manufacture lenzilumab for potential commercialization upon receipt of a regulatory authorization. R&D expense increased $38.4 million from $22.4 million for the three months ended September 30, 2020, to $60.8 million for the three months ended September 30, 2021, and increased $139.6 million from $44.2 million for the nine months ended September 30, 2020, to $183.8 million for the nine months ended September 30, 2021. The manufacturing expense included in R&D was $55.8 million for the third quarter of 2021 as compared to $10.9 million for the prior year quarter, and $162.9 million for the nine months ended September 30, 2021, as compared to $28.3 million for the prior year period. Manufacturing expense is comprised of technical transfer, start-up and production expenses for bulk drug substance (BDS) and drug product (DP). The company has built an extensive network of contract manufacturing organizations (CMOs) to produce lenzilumab BDS, to fill DP, and to establish a supply chain for lenzilumab.

On September 8, 2021, FDA declined the company’s Emergency Use Authorization (EUA) request for lenzilumab in hospitalized COVID-19 patients. Subsequently, the company has amended, and in some cases canceled, certain of its manufacturing agreements, some of which were contingent on EUA, in an effort to reduce its future spending on lenzilumab production until and if authorization is received in the UK, EU, or US. In the event of authorization by MHRA, EMA, or FDA, the company anticipates that the demand for commercial product could exceed the in process and planned production of lenzilumab through 2022. The company intends to seek additional manufacturing capacity if authorization is obtained. Production beyond 2022 would require the company to secure capacity at our CMOs and acquire the necessary supplies and components. The Company expects to use a portion of the revenues generated from commercial sale of lenzilumab following receipt of a regulatory authorization to support its efforts to expand production capacity in 2023 and beyond.

Certain of the company’s CMOs have been unsuccessful in their efforts to manufacture some batches of lenzilumab to the company’s specifications for various reasons. The company is working with these CMOs to determine if batches of BDS manufactured by them may be usable in the future or, if not, whether other financial recompense will be offered to the company.

Cash and Cash Equivalents

Net cash used in operating activities, net of balance sheet changes, was $48.0 million for the three months ended September 30, 2021, and $151.8 million for the nine months ended September 30, 2021. During the nine months ended September 30, 2021, the company raised net proceeds of $40.0 million from the sale of shares of common stock under its At-the-Market offering program, drew $25.0 million under its credit facility with Hercules Capital, providing net proceeds of $24.4 million, and completed a public offering of common stock with net proceeds of $94.2 million. As of September 30, 2021, the company had cash and cash equivalents of $76.5 million. Subsequent to September 30, 2021, the company received net proceeds of approximately $24.5 million under its At-the-Market offering program.

A summary of key financial highlights as of and for the three and nine months ended September 30, 2021 and 2020 is as follows ($ in thousands):

  Three Months Ended September 30,   Nine Months Ended September 30,
 

2021

 

2020

 

 

2021

 

2020

 

     
License revenue   $

1,036

 

$

 

  $

2,558

 

$

 

     
Research and development  

60,811

 

22,416

 

 

183,757

 

44,218

 

General and administrative  

6,204

 

8,331

 

 

19,228

 

11,685

 

     
Loss from operations  

(65,979

)

(30,747

)

 

(200,427

)

(55,903

)

     
Net loss   $

(66,739

)

$

(30,751

)

  $

(203,109

)

$

(57,240

)

     
Net loss per common share   $

(1.12

)

$

(0.71

)

  $

(3.56

)

$

(1.79

)

     
Weighted average common shares  

59,486,626

 

43,490,071

 

 

56,997,039

 

32,041,790

 

  September 30, 2021     December 31, 2020
       
Cash and cash equivalents   $

76,500

    $

67,737

       
Current assets   $

77,847

    $

68,212

       
Current liabilities  

68,709

   

20,415

       
Working capital   $

9,138

    $

47,797

About Humanigen, Inc.

Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‛cytokine storm’. Lenzilumab is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Early in the COVID-19 pandemic, investigation showed high levels of GM-CSF secreting T cells were associated with disease severity and intensive care unit admission. Humanigen’s Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent cytokine storm in hospitalized patients with COVID-19. Humanigen has submitted lenzilumab to Medicines and Health Regulatory Agency in the United Kingdom for a rolling review towards potential Conditional Marketing Authorization. Humanigen is developing lenzilumab as a treatment for cytokine storm associated with COVID-19 and CD19-targeted CAR-T cell therapies and is also exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis. For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and Facebook.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management’s current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements, including, without limitation, statements regarding: Humanigen’s beliefs as to the potential benefits of lenzilumab as a treatment for hospitalized COVID-19 patients; its efforts to request and receive Conditional Marketing Authorization for lenzilumab in COVID-19 in the UK and other territories; its beliefs and projections regarding the need for lenzilumab as a therapeutic if authorized or approved; the company’s projections for anticipated supply of lenzilumab through the end of 2022; the effectiveness of its preparations to commercialize lenzilumab in the UK and other markets, if CMA or other marketing approval were granted; its efforts to mitigate its manufacturing expenses in future periods pending receipt of a marketing authorization or approval from a regulatory agency such as MHRA, EMA or FDA; its ability to resolve payment disputes with certain of its CMOs and other service providers on favorable terms; and its other plans to initiate or participate in planned clinical trials and otherwise explore the effectiveness of lenzilumab and other candidates in its development portfolio as therapies for other inflammation and immune-oncology indications.

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in the company’s lack of profitability and need for additional capital to conduct its business; its dependence on partners to further the development of its product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; challenges associated with manufacturing and commercializing a biologic such as lenzilumab; the outcome of pending or future litigation; and the various risks and uncertainties described in the “Risk Factors” sections and elsewhere in Humanigen’s periodic and other filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. The Company undertakes no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.

References

  1. European expert group on SARS-CoV-2 variants, COVID-19 therapeutics sub-group. COVID-19 therapeutics portfolio – list of ten most promising candidates (2021). European Commission. Retrieved October 23, 2021, from https://ec.europa.eu/transparency/expert-groups-register/core/api/front/document/59939/download
  2. Coronavirus (COVID-19) in the UK – Vaccinations. (2021, October 27). Retrieved October 28, 2021, from https://coronavirus.data.gov.uk/details/vaccinations.
  3. Goldberg, Y., et al. (2021). Waning immunity after the BNT162B2 vaccine in Israel. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2114228
  4. Coronavirus (COVID-19) in the UK – Hospital Admissions. (2021, October 27). Retrieved October 28, 2021, from https://coronavirus.data.gov.uk/details/healthcare.
  5. UK Health Security Agency, COVID-19 vaccine surveillance report Week 43 (2021, October 28). Retrieved November 1, 2021, from https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1029606/Vaccine-surveillance-report-week-43.pdf.

 

Contacts

Humanigen Investor Relations
Ken Trbovich

Humanigen

trbo@humanigen.com
650-410-3206

Hess to Participate in Bank of America Securities 2021 Global Energy Conference

NEW YORK–(BUSINESS WIRE)–#BankofAmerica–Hess Corporation (NYSE: HES) announced today that John Hess, Chief Executive Officer, will speak at the Bank of America Securities 2021 Global Energy Conference on November 17, 2021 at 9:00 a.m. Eastern Time.

A live audio webcast and a replay of the presentation will be accessible via Hess Corporation’s website.

Hess Corporation is a leading global independent energy company engaged in the exploration and production of crude oil and natural gas. More information on Hess Corporation is available at https://www.hess.com/.

Cautionary Statements

This presentation will contain projections and other forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These projections and statements reflect the company’s current views with respect to future events and financial performance. No assurances can be given, however, that these events will occur or that these projections will be achieved, and actual results could differ materially from those projected as a result of certain risk factors. A discussion of these risk factors is included in the company’s periodic reports filed with the Securities and Exchange Commission.

Contacts

Investor contact:
Jay Wilson

(212) 536-8940

jrwilson@hess.com

Media contact:
Lorrie Hecker

(212) 536-8250

lhecker@hess.com

UK Healthcare Markets and Care Markets Newsletter Including Interviews with Leading Names in the Sector, In-depth Features and News Coverage – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “UK Healthcare Markets and Care Markets (without digital archive)” newsletter has been added to ResearchAndMarkets.com’s offering.

Healthcare Markets and Care Markets deliver comprehensive, reliable and independent reporting across the full spectrum of independent healthcare covering acute and primary healthcare services and social care.

These news journals jointly cover community care, older care, specialist care, medical and surgical hospitals and clinics, psychiatric hospitals, dentistry, primary healthcare and temporary/flexible staffing.

Always at the forefront of the news, the publisher’s specialist titles pride themselves on interviews with leading names in the sector, in-depth features and business news coverage which is second to none, providing invaluable insight and analysis.

Themed issues, guest writers and unique early access to the intelligence which feeds into the publisher’s leading sector reports, make Healthcare Markets and Care Markets the ‘must read’ publications covering the business of care.

Unique access to the country’s leading healthcare intelligence provider

As part of the publisher’s portfolio, the news magazines pull on key sources and market intelligence to be first with news analysis, exploring the important issues and topics which affect the sector.

A unique feature of the publications, is the access to healthcare intelligence contained within the publisher’s proprietary database and consultancy teams. This allows the implications of each article to be assessed in the context of underlying trends and emerging market forces.

The publisher is the chosen provider of independent sector healthcare market data to the UK government’s Office for National Statistics.

For more information about this newsletter visit https://www.researchandmarkets.com/r/c48t9d

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com
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