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Alligator Bioscience launches ALLIGATOR-FAB™ – a novel human antibody library

PR Newswire

LUND, Sweden, Dec. 10, 2020 /PRNewswire/ — Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced the completion of a novel proprietary human synthetic antibody library in Fab (Fragment antigen-binding) format – ALLIGATOR-FAB™. The design of the library and antibody diversity has been optimized to ensure the development of highly functional antibodies with excellent developability properties.

The ALLIGATOR-FAB library is built on multiple antibody backbones with optimal drug development properties to further increase the structural diversity of generated antibodies. The ALLIGATOR-FAB library has been shown to generate pools of highly diverse and functional antibody variants.

“ALLIGATOR-FAB is a great addition to our technology platform and perfectly complements our well-established ALLIGATOR-GOLD® library as well as the bispecific format RUBY™. With the two human antibody libraries at hand, Alligator has the capacity to generate therapeutic mono- and bispecific antibodies against virtually any target”, said Per Norlén, CEO of Alligator Bioscience.

ALLIGATOR-FAB has been key in the generation of the latest drug candidate in Neo-X-Prime, the novel immuno-oncology concept recently launched by Alligator.

For further information, please contact:

Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 08:30 a.m. CET on December 10, 2020.

About Alligator Bioscience

Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator’s pipeline includes the two key assets ATOR-1017 and mitazalimab. Furthermore, there are two partnered assets: ALG.APV-527 in co-development with Aptevo Therapeutics Inc. and AC101 in clinical development by Shanghai Henlius Biotech Inc. In addition, the company has developed a novel concept for more patient-specific immunotherapy: Neo-X-Prime. Alligator’s shares are listed on Nasdaq Stockholm (ATORX). The Company is headquartered in Lund, Sweden. For more information, please visit www.alligatorbioscience.com.

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Alligator Bioscience launches ALLIGATOR-FAB™ — a novel human antibody library

 

 

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SOURCE Alligator Bioscience

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SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Splunk Inc. – SPLK

PR Newswire

NEW YORK, Dec. 10, 2020 /PRNewswire/ — Pomerantz LLP is investigating claims on behalf of investors of Splunk, Inc. (“Splunk” or the “Company”) (NYSE: SPLK).  Such investors are advised to contact Robert S. Willoughby at  [email protected] or 888-476-6529, ext. 7980.

The investigation concerns whether Splunk and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 

[Click here for information about joining the class action] 

On December 2, 2020, post-market, Splunk announced its financial results for the quarter ended October 31, 2020.  Among other results, Splunk reported total revenues of $559 million, representing an 11% year-over-year decline and missing estimates by nearly $60 million.  Splunk also announced quarterly non-GAAP earnings per share (“EPS”) of –$0.07, missing estimates by $0.15 per share, as well as GAAP EPS of –$1.26, missing estimates by $0.24 per share.  On an earnings call with analysts that same day, Splunk’s Chief Executive Officer admitted that despite the Company having reiterated its guidance for the quarter just ten days before the close of the quarter, Splunk’s financial results fell “certainly short of both our expectations and our communication of those expectations.” 

On this news, Splunk’s stock price fell $47.88 per share, or 23.25%, to close at $158.03 per share on December 3, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT:

Robert S. Willoughby

Pomerantz LLP
[email protected] 
888-476-6529 ext. 7980

 

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SOURCE Pomerantz LLP

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EQT Infrastructure acquires Molslinjen, Denmark’s largest passenger ferry company

EQT Infrastructure acquires Molslinjen, a critical part of Denmark’s domestic transport network, linking major population centers and creating connectivity between regions as well as connecting several important islands to the mainland

Molslinjen contributes to increased economic activity and social development as an enabler of movement of passengers and goods across its network of “floating bridges”

EQT Infrastructure will support Molslinjen’s continued sustainability agenda through investments in the decarbonization of the ferry fleet and the acceleration of the transition to renewable fuel sources

PR Newswire

STOCKHOLM, Dec. 10, 2020 /PRNewswire/ — EQT is pleased to announce that EQT Infrastructure has entered into a definitive agreement to acquire Molslinjen A/S (“Molslinjen” or “the Company”) from a group of shareholders led by Polaris.

Molslinjen is headquartered in Aarhus, Denmark and was established in 1963 as a single route operator creating a shortcut between Jutland and Zealand, thereby also a connection between the country’s two largest cities. Since then, the Company has grown into Denmark’s largest passenger ferry company with over 700 employees and 15 vessels serving over eight million people per year across nine routes, including connections to Sweden and Germany. Molslinjen generated revenues of around DKK 1.9 billion in 2019. 

Operating in a country of many islands, Molslinjen is a critical part of Denmark’s transportation infrastructure. Its routes constitute a network of “floating bridges” that link Denmark’s major population centers and connect several important islands with the mainland. As an enabler of movement of passengers and goods, Molslinjen contributes to Denmark’s local and regional economic activity and social development.

Molslinjen’s long-term development is supported by strong secular trends, such as a steady population growth, increased urbanization, climate consciousness, and increasing domestic travel. The Company is well-positioned to capitalize on these shifts with its state-of-the-art ferry fleet, serving the most important travel corridors in the country.

Over the past decade, Molslinjen has reduced the CO2 emission per transported kg with over 60 percent. In the years to come, the Company will continue to invest in increased decarbonization of its ferry fleet and reduction of fossil fuel dependence. EQT Infrastructure is committed to supporting the Company’s transition to electrified ferries on selected routes and introducing renewable fuel sources for larger vessels. Moreover, EQT Infrastructure will focus on customer service improvements, such as refitting of the vessel layout, increased departure frequency and higher passenger capacity on popular routes.

Daniel Pérez, Partner at EQT Partners: “We have followed Molslinjen closely for years and are tremendously impressed with its transformation into an indispensable element of the Danish transport infrastructure, under the leadership of Carsten Jensen and his management team. The next development phase of Molslinjen will be defined by the Company’s ambitious sustainability agenda and continued investments in electrification and renewable fuel sources. In parallel, we also believe that there is scope to further build on Molslinjen’s successful inorganic growth strategy. Taken together, these investments will further future-proof the Company, and we look forward to embarking on this journey together with Carsten and the management team.”

Carsten Jensen, CEO of Molslinjen, said: “We are excited to team up with EQT Infrastructure, they are a highly strategic partner who will bring both the industry expertise and financial muscles to support Molslinjen’s green development plans. We now look forward to setting sail towards the next chapter in our growth journey together with EQT.”

The transaction is subject to customary conditions and approvals and is expected to close in early 2021.

EQT was advised by Danske Bank and DC Advisory (M&A / Financing), Accura (Legal), EY (Financial and Tax), McKinsey (Commercial) and Arup (Technical).

With this transaction, EQT Infrastructure V is expected to be 20-25 percent invested (including closed and/or signed investments, announced public offers, if applicable, and less any expected syndication) based on its target fund size, and subject to customary regulatory approvals.

Contact

Daniel Pérez, Partner at EQT Partners and Investment Advisor to EQT Infrastructure, +4673 314 99 87

EQT Press Office, [email protected], +46 8 506 55 334


About EQT

EQT is a purpose-driven global investment organization
 with more than EUR 75 billion in raised capital and over EUR 46 billion in assets under management across 16 active funds. EQT funds have portfolio companies in Europe, Asia-Pacific and North America with total sales of more than EUR 27 billion and approximately 159,000 employees. EQT works with portfolio companies to achieve sustainable growth, operational excellence and market leadership.

More info:

www.eqtgroup.com

Follow EQT on

LinkedIn
, Twitter, YouTube and Instagram

About Molslinjen

Molslinjen is Denmark’s largest passenger ferry company with over 700 employees and 15 vessels serving over eight million people per year across nine routes, including connections to Sweden and Germany. Molslinjen generated revenues of around DKK 1.9 billion in 2019. In cooperation with Herning Turist, Molslinjen is operating busses under the brand Kombardo Expressen on direct busroutes to/from Copenhagen – Aarhus, Aalborg, Randers, Holstebro, Herning, Silkeborg and Rønne.

More info:


www.molslinjen.dk

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https://mb.cision.com/Main/87/3252163/1346569.pdf

Press release EQT Infrastructure Molslinjen 201210

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SOURCE EQT

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ESI Group Gathered Industry Leaders in a Global Digital Event to Discuss Transformation and Cross-Fertilization of Ideas Across Industries

ESI Group Gathered Industry Leaders in a Global Digital Event to Discuss Transformation and Cross-Fertilization of Ideas Across Industries

PARIS–(BUSINESS WIRE)–ESI Group (Paris:ESI), global player in virtual prototyping software and services for industries, launched its first global digital series of events with leaders of various industries – ESI Live. The objective: share experiences in digital transformation, across industry sectors. Globalized competition, shorter lead time, costs pressure, stringent environmental regulations, and the COVID-19 pandemic drive manufacturers to innovate. Automotive, Aerospace, Heavy Machinery, Energy… how does each industry break new ground to better meet consumer expectations?

ESI Live started on November 5th and continued with an Americas bonus session held on November 17th. These first events gathered over 600 attendees from across the globe and from all the Group industry sectors, and even more thanks to the replays, which are available now on-demand.

Among speakers taking part of the event, in the Automotive sector:

– Atsushi Mizutani, Expert leader, Production Engineering R&D Center at Nissan Motors Corporation, demonstrated how virtual prototyping is speeding up the development of car parts made from carbon fiber reinforced plastics (CFRP). Light yet extremely strong, this material will be used to make safer and more fuel-efficient cars.

– Dr. Weiran Jiang, Simulation & Advanced Modeling Director at Farasis Energy. The Chinese American battery provider won in record-breaking time a call for tenders made by a premium German automotive OEM. Thanks to ESI’s expertise, the reliability of the virtual prototype of the new Farasis battery model was decisive in a “zero real prototype” approach stipulating the elimination of any physical prototype.

– Dr. Jiri Svoboda, from the auditing and certification organization TÜV SÜD, showed how, thanks to a method combining physical and virtual testing, to ensure the performance and safety of autonomous vehicles.

In the Aerospace industry:

– Kaname Kawatsu, Associate Senior Researcher at Japanese Aerospace Exploration Agency (JAXA), has relied on simulation to develop risk assessment models evaluation for affordable maintenance and space system robustness.

– Thierry Eftymiades, Senior Vice President Engineering at Latécoère, aeronautical equipment manufacturer, focused on the collaborative benefits of the virtual reality solution IC.IDO.

Immersion in the model allows their stakeholders around the globe to quickly appropriate the future product and understand its interaction with its environment, from the first steps of the project.

For Heavy Machinery & Energy Industries:

– Galen Faidley, Senior Engineering Project Team Leader at Caterpillar Inc., who has implemented ESI’s immersive virtual reality solution in its manufacturing processes to speed up machine development.

– Jean-Marie Hamy, Advanced Reactors & Design School Department Manager at Framatome, carried the ASTRID project for the implementation of virtual reality to design new nuclear reactors. IC.IDO made it possible to create at the same time the design of future buildings as well as their interconnection. The solution stood up thanks to its easy implementation and interoperability with CAD models coming from various sources. The results met the goals: to facilitate “zero default” conception in a collaborative way, restrict the number of physical interventions at the end of processes, enable to simulate the integration of complex systems and operational feasibility in constrained environments, and finally to allow training of the different teams involved in the project.

Mike Salari ESI Group EVP and Americas Regional Manager, facilitated a high-level discussion with David Johnson, VP Production Engineering and New Model Quality for Nissan North America, Scott Pryer, Partner at Pryer Aerospace and Beckwood Press and Marcus Paulo Nery, LATAM Virtual Integration Lead at Fiat Chrysler Automobiles. Cristel de Rouvray, CEO of ESI Group, hosted a thought leadership panel with Vincent Champain, SEVP Digital & IT at Framatome, and Ignacio Martin, BiW R&D General Director at Gestamp. In both panels the speakers discussed their company’s approach to digital transformation and how they’re benefiting from synergies between industries.

With this digital series, ESI reinforced its commitment to our Planet. The company estimates that by avoiding all travel, they helped save around 223 tons of CO2 in total.

Click here to access all the on-demand content.

About ESI Group

Founded in 1973, ESI Group is a leading innovator in Virtual Prototyping solutions and a global enabler of industrial transformation. Thanks to the company’s unique know-how in the physics of materials, it has developed and refined, over the last 45 years, advanced simulation capabilities. Having identified gaps in the traditional approach to Product Lifecycle Management (PLM), ESI has introduced a holistic methodology centered on industrial productivity and product performance throughout its entire lifecycle, i.e. Product Performance Lifecycle™, from engineering to manufacturing and in operation. Present in more than 20 countries, and in major industrial sectors, ESI employs 1200 high level specialists. In 2019, its turnover was 146M€. ESI is headquartered in France and is listed on compartment B of Euronext Paris. For further information, go to www.esi-group.com.

Suivez ESI

LinkedIn

Facebook

Twitter

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ESI Group

Florence Barré

[email protected]

+33 1 49 78 28 28

Press Relationship – Shan

Lola Gozlan

[email protected]

+ 33 6 24 76 83 40

KEYWORDS: France Europe

INDUSTRY KEYWORDS: Engineering Technology Aerospace Other Technology Manufacturing Software

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IRRAS Announces Expansion of IRRAflow Launch to Latin America

– Finalization of agreement with distribution partner in Argentina allows access into initial Latin American markets

– Anade SA is a well-established partner with deep existing relationships in neurosurgical space

PR Newswire

STOCKHOLM, Dec. 10, 2020 /PRNewswire/ — IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced an exclusive distribution agreement with Anade SA, a well-established distributor of leading neurosurgical medical devices and technologies through Latin America.

“We are pleased to partner with Anade SA to expand the commercial availability of our IRRAflow product line to physicians and patients throughout multiple markets in Latin America,” said Coenraad Tamse, Vice President of International Sales for IRRAS. “Currently, IRRAflow has received regulatory clearance in Costa Rica and Argentina, and regulatory clearance is being pursued in 5 additional markets. This partnership allows us to accelerate commercial launches in these markets with the capable sales professionals of Anade and its sub-distribution partners identifying and training customers in each of these new markets.”

Miguel Ferro, Vice President of Anade SA, added, “We are excited to bring an exciting product, such as IRRAflow, to these initial markets in Latin America. IRRAflow clearly complements our existing neurosurgery portfolio by providing a next generation solution for the treatment of intracranial bleeding, and our team is actively working with leading physicians to plan an effective product launch.”

About IRRAS

IRRAS is a global medical care company focused on delivering innovative medical solutions to improve the lives of critically ill patients. IRRAS designs, develops, and commercializes neurocritical care products that transform patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methodologies. IRRAS markets and sells its comprehensive, innovative IRRAflow and Hummingbird ICP Monitoring product lines to hospitals worldwide through its direct sales organization in the United States and select European countries as well as an international network of distribution partners.

IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more information, please visit www.irras.com.

IRRAS is listed on Nasdaq Stockholm (ticker: IRRAS).

For more information, please contact:


USA

Kleanthis G. Xanthopoulos, Ph.D.
CEO
[email protected]


Europe

Sabina Berlin

CFO
+46 73 951 95 02
[email protected]

The information was released for public disclosure, through the agency of the contact person above, on December 10, 2020 at 08:00 (CET).

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SOURCE IRRAS

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SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of scPharmaceuticals Inc. – SCPH

PR Newswire

NEW YORK, Dec. 10, 2020 /PRNewswire/ — Pomerantz LLP is investigating claims on behalf of investors of scPharmaceuticals Inc. (“scPharmaceuticals” or the “Company”) (NASDAQ: SCPH). uch investors are advised to contact Robert S. Willoughby at  [email protected] or 888-476-6529, ext. 7980.

The investigation concerns whether scPharmaceuticals and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 

[Click here for information about joining the class action] 

On December 7, 2020, scPharmaceuticals issued a press release announcing receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) on December 3, 2020 regarding the Company’s New Drug Application (“NDA”) for the Company’s FUROSCIX product.  The Company’s press release stated that “[i]n the CRL, the FDA cited their need to conduct pre-approval inspections at two of the company’s third-party manufacturing facilities that could not be conducted due to travel restrictions.  In addition, the FDA raised questions related to testing, labeling, and features of the combination product unrelated to the drug constituent.  In addition, the FDA indicated that there were deficiencies at the third-party facility where the Company’s off-the-shelf alcohol swabs are manufactured.” 

On this news, scPharmaceuticals’ stock price fell $3.11 per share, or 35.58%, to close at $5.63 per share on December 7, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT:

Robert S. Willoughby

Pomerantz LLP
[email protected]
888-476-6529 ext. 7980

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SOURCE Pomerantz LLP

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Realising opportunities for future growth and financial update: Sobi Capital Markets Day 2020

PR Newswire

STOCKHOLM, Dec. 10, 2020 /PRNewswire/ — Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) is hosting a virtual Capital Markets Day today. Presentations from senior management will showcase Sobi’s strategy for growth in the core areas of Immunology and Haematology, strengthening its pipeline, extending its geographical footprint and expanding growth opportunities. New peak sales expectations for key products as well as revenue ambition for 2025 are communicated.  

“Sobi has been through a significant transformation in the past few years and we are now well positioned for the next phase,” says Guido Oelkers, CEO and President of Sobi. “Our R&D portfolio with 12 possible new indications will allow us to address significant unmet medical need. Our comprehensive launch plan in combination with our international expansion underpin our ambition to reach revenues of SEK 25 billion in 2025.”

Highlights of the Capital Markets Day

Capture the value of the pipeline: By delivering on our late-stage pipeline, we will further enhance patient access to innovative medicine and the growth profile of the company. Sobi today has 12 late-stage programmes with the potential to meet significant unmet medical need and position Sobi for long-term growth.

Lead in Haematology and grow Immunology: Sobi’s core products within Haematology and Immunology are expected to continue to deliver strong growth driven by new indications, new markets and further patient gains over the planning horizon until 2025.

Go global: Sobi will continue the ongoing internationalisation of its operations. Recently added products with global rights open up new opportunities outside of Europe and the US. Apart from China and Japan, opportunities are being explored in Latin America, South-East Asia and Australia. Revenue from the international expansion is expected to exceed SEK 4 billion by 2025.

Revenue

The ambition is to reach revenue of SEK 25 billion by 2025, implying single digit growth short term and accelerated growth from 2023. New peak sales expectations for haemophilia is estimated to SEK 8-10 billion, pegcetacoplan to SEK 5-12 billion and SEL-212 to SEK 3-5 billion.

Increased investments in R&D and commercialisation:

The recent additions to the late-stage pipeline will drive investments in R&D mid-term. The previous level of R&D costs at around 10 per cent of revenue is expected to increase to 13-15 per cent during 2021-2022.

Launches and internationalisation of operations will require further investments in infrastructure and increase SG&A spend over revenue short term.

The EBITA margin is expected to accelerate from 2023.

About SobiTM

Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative therapies in the areas of haematology, immunology and specialty indications. Today, Sobi employs approximately 1,500 people across Europe, North America, the Middle East, Russia and North Africa. In 2019, Sobi’s revenue amounted to SEK 14.2 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at www.sobi.com.

This information is information that Swedish Orphan Biovitrum AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08:00 CET on 10 December 2020.

Contact

Paula Treutiger, Head of Communication & Investor Relations
+ 46 733 666 599
[email protected]

 

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/swedish-orphan-biovitrum-ab/r/realising-opportunities-for-future-growth-and-financial-update–sobi-capital-markets-day-2020,c3252081

The following files are available for download:


https://mb.cision.com/Main/14266/3252081/1346484.pdf

Realising opportunities for future growth and financial update: Sobi Capital Markets Day 2020

 

 

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SOURCE Swedish Orphan Biovitrum AB

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Calliditas wins the 2020 SwedenBio Award

PR Newswire

STOCKHOLM, Dec. 10, 2020 /PRNewswire/ — The winner of this year’s SwedenBIO Award was announced on Wednesday December 9th. Calliditas Therapeutics AB (publ) (“Calliditas”) received the award in recognition of its successful clinical development program of Nefecon, which culminated in the recent positive topline data readout of the pivotal Phase 3 NefIgArd trial.

SwedenBio annually awards this prize to a company which has excelled in terms of R&D, business development and growth whilst contributing to societal benefit.

“This year’s winner has shown impressive professionalism and staying power with regards to the development of a completely new treatment for patients with IgA Nephropathy, a disease which lacks approved treatments today. With positive Phase 3 results in place, preparations for a submission for regulatory approval and subsequent commercialization in the US are now underway,” said Lars Adlersson, Chairman of SwedenBIO.

The SwedenBIO Award aims to increase visibility for the life science industry by drawing attention to and rewarding successful and exemplary member companies that have particularly excelled and contributed to positive attention for the industry. A record number of companies were nominated for this year’s award.

“We are delighted to have been selected for this prestigious award, which recognizes the Company’s longstanding commitment to addressing a significant unmet medical need for patients with IgA Nephropathy. We look forward to continuing to build on this success to deliver solutions to patients with orphan diseases”, said CEO Renée Aguiar-Lucander.

For further information, please contact:

Marie Galay, IR Manager, Calliditas

Tel.: +44 79 55 98 12 45, email: [email protected]

The information was sent for publication, through the agency of the contact persons set out above, on December 10, 2020 at 08:00 a.m. CET.

About Calliditas

Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’ lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for further information.

 

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SOURCE Calliditas Therapeutics

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Ultimovacs Announces Positive 5-Year Overall Survival Update from Phase I Combination Trial Evaluating Universal Cancer Vaccine UV1 in Metastatic Melanoma

Ultimovacs Announces Positive 5-Year Overall Survival Update from Phase I Combination Trial Evaluating Universal Cancer Vaccine UV1 in Metastatic Melanoma

OSLO, Norway–(BUSINESS WIRE)–Ultimovacs ASA (“Ultimovacs”, ticker ULTI), today announced positive five-year Overall Survival (OS) data from the Phase I trial evaluating the company’s universal cancer vaccine, UV1, in combination with the checkpoint inhibitor, ipilimumab, in patients with metastatic malignant melanoma. After 5-years of follow-up, 50% of the patients in the open-label trial were still alive, providing encouraging signals of long-term survival benefit for UV1 in this late-stage patient population and as compared to historical data of ipilimumab monotherapy. As previously reported at ASCO-SITC in 2020, the trial achieved its primary endpoints of safety and tolerability. These results represent the third clinical trial with UV1 to provide positive data for 5-years of patient follow-up, further strengthening UV1’s profile as a safe and potentially effective addition to immuno-oncology treatment regimens.

“When we look at the trial results of ipilimumab monotherapy conducted in nearly identical clinical settings and patient population, we see in the literature a 5-year survival rate around 20%, median overall survival of around 16 months and median progression free survival of about 3.5 to 4 months,” stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. “Combining ipilimumab, which was the standard-of-care treatment at the time of the study initiation, with UV1, resulted in promising signs of improved survival with a safe and well-tolerated profile. At 5 years of follow-up, the median overall survival had not been reached and 50% of the patients were still alive, which are encouraging results in patients with metastatic melanoma.”

A total of 12 malignant melanoma patients with metastatic disease were treated in the Phase I trial. Eight patients of the 12 received UV1 combined with ipilimumab as first line treatment, and the remaining four patients received the combination after progression on previous systemic treatment. Immune responses toward the UV1 peptides occurred very early post administration, with 91% of the evaluable patients showing an immune response. In the efficacy-evaluable patient population, one patient achieved a complete tumor response and three patients achieved a partial response, resulting in an objective response rate of 44%. Primary endpoints for the study included the safety and tolerability of UV1 as well as initial signs of clinical response. As per the data cut-off at the end of November 2020, every patient in the trial reached at least 60 months of follow-up post treatment with UV1 and ipilimumab. At the five-year mark, the OS rate was 50%, median OS had not yet been reached and median Progression Free Survival (mPFS) was 6.7 months. Over the course of the follow-up period, none of the patients experienced any unexpected safety issues related to UV1.

“In all four Phase I trials where UV1 has been tested, we have observed a consistent set of positive signals of clinical effect and a good safety profile for UV1. This strengthens our commitment to developing UV1 as a potential universal cancer vaccine that can be applied across multiple indications, in different combinations with other cancer treatments and in different stages of cancer,”stated Carlos de Sousa, Chief Executive Officer at Ultimovacs.“Our ongoing INITIUM Phase II clinical trial combines UV1 with ipilimumab and nivolumab in this patient population and today’s results reinforce the confidence we have in our approach of directing the immune system towards telomerase expressing cancer cells to improve clinical outcomes for patients in need of new treatment options.”

About UV1

UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as a therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action. To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

About UV1 Clinical Programs

As a universal cancer vaccine, UV1’s unique mechanism of action has the potential to be applicable across most cancer types. The clinical development of the UV1 vaccine includes three randomized, multinational, Phase II combination trials recruiting more than 400 patients in total. The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic malignant melanoma to evaluate UV1 in combination with ipilimumab and nivolumab as first-line treatment. The NIPU study is testing UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab as second-line treatment in 118 patients with advanced malignant pleural mesothelioma, a rare lung cancer. The study is sponsored by Oslo University Hospital and Bristol-Myers Squibb is providing the checkpoint inhibitors for this study. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2022. A third Phase II clinical trial will evaluate UV1 in a new cancer indication in combination with indication-specific standard of care cancer therapies different from those to be tested in INITIUM and NIPU. In this new collaboration, Ultimovacs will supply UV1 and a big pharma company will supply its proprietary cancer treatment to the clinical trial group which will sponsor the trial.

About Ultimovacs

Ultimovacs’ UV1 universal cancer vaccine candidate leverages the high prevalence of the human telomerase (hTERT) to be effective across the dynamic stages of the tumor’s growth and its microenvironment. By directing the immune system to hTERT antigens that are present in over 80% of all cancers, UV1 drives CD4 helper T cells to the tumor with the goal of activating an immune system cascade to increase anti-tumor responses. Ultimovacs’ strategy is to clinically demonstrate UV1’s impact in a range of cancers and in several immunotherapy combinations while expanding our pipeline of cancer vaccine therapies, convinced that a universal approach may be the key to achieving better outcomes for patients.

For further information, please see www.ultimovacs.com.

Carlos de Sousa, Chief Executive Officer

Email: [email protected]

Phone: +47 908 92507

Hans Vassgård Eid, Chief Financial Officer

Email: [email protected]

Phone: +47 482 48632

KEYWORDS: Norway Europe United States North America New York

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

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Airbnb Announces Pricing of Initial Public Offering

PR Newswire

SAN FRANCISCO, Dec. 9, 2020 /PRNewswire/ — Airbnb, Inc. today announced the pricing of its initial public offering of 51,323,531 shares of Class A common stock, 50,000,000 of which are being sold by Airbnb and 1,323,531 of which are being sold by certain selling stockholders, at a public offering price of $68.00 per share. In addition, Airbnb has granted the underwriters a 30-day option to purchase up to an additional 5,000,000 shares of Class A common stock at the initial public offering price, less underwriting discounts and commissions. Airbnb’s Class A common stock is expected to begin trading on the Nasdaq Global Select Market on December 10, 2020, under the ticker symbol “ABNB.” The gross proceeds from the offering to Airbnb, before deducting underwriting discounts and commissions and other offering expenses payable by Airbnb, are expected to be approximately $3.4 billion, excluding any exercise of the underwriters’ option to purchase additional shares. Airbnb will not receive any proceeds from the sale of shares by the selling stockholders. The offering is expected to close on December 14, 2020, subject to the satisfaction of customary closing conditions.

Morgan Stanley, Goldman Sachs & Co. LLC and Allen & Company LLC are acting as lead book-running managers for the offering. BofA Securities, Barclays and Citigroup are acting as book-running managers. BNP PARIBAS, Mizuho Securities, Credit Suisse, Deutsche Bank Securities, Jefferies and Wells Fargo Securities are acting as joint book-running managers. Baird, Canaccord Genuity, Cowen, D.A. Davidson & Co., JMP Securities, KeyBanc Capital Markets, Needham & Company, Oppenheimer & Co., Piper Sandler, Raymond James, Stifel, Wedbush Securities, William Blair, Academy Securities, Blaylock Van, LLC, CastleOak Securities, L.P., C.L. King & Associates, Guzman & Company, Loop Capital Markets, MFR Securities, Inc., Mischler Financial Group, Inc., Ramirez & Co., Inc., Siebert Williams Shank, Telsey Advisory Group and Tigress Financial Partners are acting as co-managers for the offering.

A registration statement relating to the shares being sold in this offering was filed with the Securities and Exchange Commission and became effective on December 9, 2020. The offering is being made only by means of a prospectus, copies of which may be obtained, when available, from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at [email protected]; Allen & Company LLC, Attention: Prospectus Department, 711 Fifth Avenue, New York, NY 10022, by telephone at (212) 339-2220, or by email at [email protected]; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or via email: [email protected]; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (888) 603-5847; or Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

 

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SOURCE Airbnb, Inc.