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Positive Phase 1 results in high-dose setanaxib trial

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Genkyotex SA, a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset.

The Phase 1 study demonstrated that setanaxib is well tolerated at the doses tested, with no safety signal or dose-limiting toxicity being identified.  The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA.  The study assessed the safety and pharmacokinetics of oral setanaxib at selected doses in 46 healthy adult male and female subjects.  The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day.

Previously, doses of up to 800 mg/day were evaluated in a 24-week Phase 2 trial in PBC patients. In that trial, setanaxib dosed at 800 mg/day achieved reductions in markers of cholestasis, including alkaline phosphatase, and in multiple non-invasive markers of liver fibrogenesis, including liver stiffness and PRO-C3 and C3M. Significant improvement in fatigue was also achieved. All doses tested in that trial were well-tolerated, with no safety signal compared to placebo.

“This result provides a foundation for a clinical development program using higher doses of setanaxib across a variety of orphan indications.  This includes the potential to launch a pivotal phase 2/3 trial with a clearly differentiated drug candidate in PBC but will also allow us to further explore a select number of kidney related orphan diseases in which inflammation and fibrosis play a part.”, said CEO Renée Aguiar-Lucander.

Calliditas acquired 62.7% of the share capital and voting rights of Genkyotex, in November 2020, before submitting a simplified public mandatory offer to the shareholders of Genkyotex on 26 November 2020. Calliditas controls 86.2% of the share capital and total number of votes of Genkyotex.

For further information, please contact:

Marie Galay, IR Manager, Calliditas

Tel.: +44 79 55 98 12 45, email: marie.galay@calliditas.com

The information was sent for publication, through the agency of the contact persons set out above, on January 18, 2021 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.

About Genkyotex

Genkyotex (Euronext Paris and Brussels: GKTX) is a leader in NOX therapies. Its unique therapeutic approach is based on a selective inhibition of NOX enzymes, which amplify disease processes such as fibrosis, inflammation, pain processing, cancer development, and neurodegeneration. Genkyotex’s discovery platform enables the identification of orally available small-molecules that selectively inhibit specific NOX enzymes. From this, Genkyotex has developed a pipeline of first-in-class product candidates targeting one or multiple NOX enzymes. The lead product candidate setanaxib, a NOX1 and NOX4 inhibitor, demonstrated clinical evidence of anti-fibrotic activity in liver fibrosis and improvement of fatigue in patients in a Phase II trial in primary biliary cholangitis (PBC, a fibrotic orphan disease). Setanaxib is also being evaluated in investigator-initiated Phase II clinical trials in Type 1 Diabetes and in idiopathic pulmonary fibrosis (IPF), a chronic lung disease that results in fibrosis of the lungs.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the regulatory pathway for setanaxib, development plans for setanaxib, plans for the conduct of and likelihood of success of planned and ongoing clinical trials of setanaxib, Calliditas’ strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to regulatory filings submissions for setanaxib, the ongoing and planned clinical trials of setanaxib, Calliditas’ business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled “Risk Factors” in Calliditas’ reports and other filings filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

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

https://news.cision.com/calliditas-therapeutics/r/positive-phase-1-results-in-high-dose-setanaxib-trial,c3269290

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BenzingaEditorial

Moderna Misses Expectations But Things Are More Than Fine

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Moderna (NASDAQ: MRNA) saw its stock jump on Thursday despite growing losses, after the Covid-19 vaccine-maker reported more than double the revenue Wall Street predicted. Moderna missed EPS expectations with revenue far surpassing analyst forecasts as the company first began to recognize revenue from sales of its COVID-19 vaccine in December 2020. The loss was simply a result of heavy investment to increase production of its COVID-19 vaccine.

The company has spent the past two months producing and shipping its much-awaited coronavirus vaccine but its fourth-quarter is merely the surface of its vaccine success. In 2021, Moderna plans to manufacture 600-700 million doses of its COVID-19 vaccine but it should be able to expand its capacity to 1.4 billion doses in 2022 due to heavy capital investments, all of which should result in massive profits.

Q4 and FY 2020

For the fourth quarter ended December 31s, quarterly loss of $0.69 per share was below Zacks Consensus Estimate of $0.25 but Moderna brought in $570.75 billion in sales. That crushed the average estimate of analysts surveyed by FactSet for $279.4 million andsurpassing the Zacks Consensus Estimate by 74.76%. Just one year ago, revenues amounted to $14.06 million but until its mRNA-1273 coronavirus vaccine, the company had never brought an approved medicine to the market.

Losses grew to 69 cents per share after a 37-cent per-share loss in the year-ago period, whereas analysts expected a 34-cent loss. Although a big portion of revenue still came from the grant received from the Biomedical Advanced Research and Development Authority to advance its Covid vaccine, for the first time,Moderna had product sales, and they amounted to $199.87 million as the company began recognizing Covid vaccine sales in December. Although losses widened in 2020, Moderna’s sales skyrocket to $803.4 million.

Possible threat

One of the biggest risks ahead for all vaccine makers is the prevalence of new coronavirus variants. To tackle this, Moderna is investigating two upgrades. The first is actually a third dose of vaccine that would increase neutralizing antibody levels to better fend off new strains. The second is a strain-specific upgraded version which has been moved into preclinical and phase 1 trials as of end of January. Moderna is designing it to target the. If successful, the company should be able to quickly adapt it to protect against future strainsalthough it is designed to target the South African variation.

Teenagers

In early December, Moderna began a phase 2/3 trial of its covid vaccine in young adults who are 12 to 17years old. The data will be reported in spring and should result in Emergency Use Authorization just in time for the back-to-school period in September. But as of last month, Moderna didn’t have enough adolescent volunteers.

Teens aren’t at the greatest risk from serious COVID-19 complications but they play a role in the transmission of the virus, so their vaccination is another  important element in containing the pandemic.

2021

The company expects $18.4 billion in full-year 2021 sales of its Covid vaccine. The figure is based on already inked advance purchase agreements but additional discussions are ongoing for both 2021 and 2022. That outlook shattered forecasts as analysts expected $11 billion. Furthermore, the company said it plans to make 700 million doses of its vaccine this year, while still working to bring that capacity up to 1 billion. In 2022, Moderna expects be able to produce 1.4 billion doses.

Chief Executive Stephane Bancel called 2020 a historic year for the company as it trailed Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) by a week in the U.S by gaining emergency use authorization. The vaccine is Moderna’s first commercial product with 32 million doses having been administered in the U.S. to millions of people around the world.

In 2020, Moderna went from knowing mRNA vaccines can be highly efficient it went to cash-flow generating commercial company that is helping save the world form the claws of an invisible enemy. The latest reported quarter ended a milestone year for the biotech company. 2020 was a year in which the world went dark but the pandemic helped Moderna shine as it provided us with a glimpse of light at the end of the tunnel. Since the beginning of 2021, its shares gained 38.6%, greatly exceeding S&P 500’s gain of 4.5%.

This article is not a press release and is contributed by a verified independent journalist for IAMNewswire. It should not be construed as investment advice at any time please read the full disclosure. IAM Newswire does not hold any position in the mentioned companies. Press Releases – If you are looking for full Press release distribution contact: press@iamnewswire.com Contributors – IAM Newswire accepts pitches. If you’re interested in becoming an IAM journalist contact: contributors@iamnewswire.com

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BenzingaEditorial

Li Did Good But Not Good Enough

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Li Auto Inc (NASDAQ: LI) earnings were good but guidance wasn’t good enough as Chinese electric-vehicle maker reported solid fourth-quarter numbers Thursday. Despite producing a surprise profit, stock reversed and Li wasn’t the only one. Nio Limited (NYSE) who is due to report Monday fell 9.7% and Xpeng Inc (NYSE: XPEV) lost 8.55% Thursday. Tesla (NASDAQ: TSLA) gave up 8.1%. Earlier this week, Texas-based Hyliion (Holdings Corporation (NYSE: HYLN), which makes EV powertrains for commercial fleets, reported a loss of 13 cents a share in the fourth quarter.

Figures

The results were a little confusing, but good as Li reported $636 million in sales as revenue jumped 39%, exceeding $604 million that analysts projected in sales. The company reported a loss from operations but a positive net income. Still, the loss from operations was about $12 million which is smaller than expected. Li Auto earnings came in at 2 cents a share whereas analysts expected a loss of 4 cents on a revenue of $565.5 million. The company also generated positive free cash flow. Investors like it when young companies demonstrate the ability to be self-funding by generating the cash they need to grow from their own operations.

Throughout the quarter, Li delivered 14,464 of its Li One SUV, its only vehicle in production which is technically a hybrid because it has a small gas engine to extend its range. This is 67% more than third quarter’s 8,660 with the total for 2020 being approximately 32,624 deliveries Its rival Nio (NYSE: NIO) sold 17,353 units in Q4 and 43,728 for the year, while Xpeng (NYSE: XPEV) sold 12,964 in Q4 and 27,041 for the year. What enabled Li to deliver a bottom-line profit from an operating loss is the required accounting of securities.

Outlook

Management expects first quarter revenue to come in the range of $450.6 million to $493.5 million. This range would represents a growth between 246% and 279% compared to previous fiscal year’s quarter. Deliveries are expected to be in the range between 10,500 and 11,500 vehicles, up 263%-297% compared to the same quarter last year but less than the fourth quarter which will make reaching analyst projections for 2021 sales projections more challenging. The company reported that January deliveries soared 356% YoY to 5,379 but that is below December 2020’s 6,126.

As the automotive industry is undergoing a once-in-a-century shift to smart EVs, the fourth quarter ended a big year for Li that grew significantly due to strong demand for its distinctive product offering and superior user experience. Government’s support for EVs also doesn’t hurt as to encourage adoption, not only are license plates guaranteed but they are also free.

The earnings provided a sigh of relief for investors as Li stock has had a rocky ride lately. As of Wednesday’s close, shares were down about 11% month to date.

This article is not a press release and is contributed by a verified independent journalist for IAMNewswire. It should not be construed as investment advice at any time please read the full disclosure. IAM Newswire does not hold any position in the mentioned companies. Press Releases – If you are looking for full Press release distribution contact: press@iamnewswire.com Contributors – IAM Newswire accepts pitches. If you’re interested in becoming an IAM journalist contact: contributors@iamnewswire.com

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BenzingaEditorial

Baidu Is Determined To Show It Has More to Offer

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For two decades, the 21-year-old company has been viewed as an online marketing tool that sells ads through its web search results. But now, the internet company is ready to show it has much more to offer. Last week, it reported fourth quarter earnings for 2020 that beat market expectations and revealed its ambitious plans to enter the EV land. Many years of investing in AI has finally started to pay off as Baidu is finally monetizing the technology used with smart devices. Company’s investments in non-core businesses iarealso helping it defend its core search platform from rivals Alibaba (NYSE: BABA), Tencent Holdings (OTC: TCEHY) and privately-ownedByteDance, whose products are just as popular.

The Chinese tech giant has recovered from the worst impact that the pandemic had on its business as advertising rebounded. Moreover, non-marketing revenue which excludes advertising and includes its cloud and autonomous driving business, grew 52% YoY. Baidu is also tapping into capital markets, including a potential second listing in Hong Kong. Baidu beefs up its autonomous and smart transport technology to tainto the EV market as it revealed back in January it would set up a smart electric vehicle (EV) company with Geely.

As the domestic economy recovers, the company want to tap into into the fast-growing electric-vehicle market to diversify revenue sources.

Figures

Full year revenue for 2020 amounted to $16.4 billion which is flat compared to 2019. Adjusted earnings of $3.08 per share versus analyst estimates of $2.79 per share came after revenues of $4.6 billion versus analyst estimates of $4.7 billion, according to FactSet.

The company provided guidance for the undergoing quarter that was ahead of analyst estimates. Revenue is expected to be in the $4.0 billion and $4.4 billion, representing a growth rate of 15% to 26% YoY, but it does not include potential contribution from its acquisition of live streaming app YY Live. The acquisition was announced last November and is expected to close in the first half of the year. The guidance is also based on the assumption that its core revenue will grow between 26% and 39% on a YoY basis.

EVs

Baidu places a lot of emphasis on its Apollo self-driving technology. Last month, the company formed a strategic partnership with the Chinese car company Zhejiang Geely Holding Group to create a standalone electric car company. Baidu is the majority shareholder. Together, they aim to launch a smart EV model inthree years. Robin Li, Baidu’s CEO Li also said a brand name has been chosen but did not release it.

CNBC has confirmed Xia Yiping, co-founder of bike-sharing start-up Mobike, will be the CEO of the new entity. Xia previously worked at Fiat Chrysler (NYSE: FCAU) and Ford before co-founding a company that was part of China’s boom and eventual bust in shared bike start-ups.

Even Xiaomi is following Baidu’s EV footsteps as the Chinese search engine leader has been basking in newfound investor love as the next EV-maker wannabe. Unlike other EV makers, Baidu’s strategy is akin to Google’s (NASDAQ: GOOGL) (NASDAQ: GOOG) Android for smartphones.

Outlook

Baidu ended an unprecedented year on a solid note and showed it is recovering from the consequences of the global health crisis as its business benefited from an improving macroeconomic environment and the digitalization of businesses and lifestyles. Its commitment on innovation through technology is paying off for the Chinese tech giant. Baidu is well positioned as a leading AI company with a strong foundation to seize the enormous market opportunities in cloud services, autonomous driving, smart transportation, along with all kinds of new opportunities that AI will inevitably bring to the table. The online marketing company chose to be in the right place, at the right time.

This article is not a press release and is contributed by a verified independent journalist for IAMNewswire. It should not be construed as investment advice at any time please read the full disclosure. IAM Newswire does not hold any position in the mentioned companies. Press Releases – If you are looking for full Press release distribution contact: press@iamnewswire.com Contributors – IAM Newswire accepts pitches. If you’re interested in becoming an IAM journalist contact: contributors@iamnewswire.com

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