Blog: 5 things to know for May 7: Coronavirus, GOP, school violence, voting limits, Brexit – ABC17News.com

Steel prices have tripled since plummeting at the beginning of the pandemic. That sounds like good news, but analysts warn it could be a bubble just waiting to burst.

Here’s what you need to know to Get Up to Speed and On with Your Day.

(You can also get “5 Things You Need to Know Today” delivered to your inbox daily. Sign up here.)

1. Coronavirus

About 185 million Americans could be fully vaccinated by September, according to the latest vaccination models. That’s roughly 88% of the adult population, but experts say it’s a race against time to fend off a winter surge as virus variants like the one driving the crisis in India become more prominent. Booster shots may also be needed in the coming months to keep up immunity. India reported 414,188 new Covid-19 cases today, a new daily high. Brazil has topped 15 million Covid-19 cases, but there’s some hope on the horizon after the government announced it will buy an extra 100 million Pfizer vaccine doses.

2. GOP

Rep. Liz Cheney may soon be ousted from her position as the No. 3 House Republican because of her repeated callouts of fellow GOP members who have pushed the “big lie” that the 2020 election was somehow stolen from former President Trump. House Republican Leader Kevin McCarthy is leading the charge to remove her from her position, saying she isn’t “carrying out the message” to help the party take back the majority. Cheney hasn’t shown any intention of stepping down as House Republican conference chair, so her ouster would have to happen through a conference vote. Her likely successor? Rep. Elise Stefanik, a Trump loyalist who has nonetheless drawn some criticism within her party for her less-conservative voting record.

3. School violence

Troubling incidents of school-related violence rattled two communities yesterday. In Rigby, Idaho, a sixth-grader allegedly pulled a handgun out of her backpack and started shooting in a hallway, injuring two fellow students and an adult. The district superintendent said an event like this is the “worst nightmare a school system can face.” In Columbia, South Carolina, a Fort Jackson trainee is in custody after allegedly hijacking a school bus full of students on its way to an elementary school. According to video and the sheriff, the suspect boarded the bus, held a rifle to the driver and told him to drive to the next town. The 18 children on board and the driver weren’t hurt. The suspect faces kidnapping, armed robbery, carjacking and other charges.

4. Voting

Florida and Texas are looking to join the growing list of states enacting controversial voting laws based on Trump’s false claims of voter fraud in the 2020 election. Florida Gov. Ron DeSantis signed a bill yesterday that includes stricter voter ID requirements for voting by mail, limits on who can pick up and return a voter’s ballot, a ban on private funding for elections and stricter drop box rules. The new law will face immediate legal challenges from activist groups. The Texas House of Representatives moved a bill forward today that would add new voting restrictions and penalties. It still needs to bounce around the state House and Senate before final votes, but business groups and voting rights organizations are primed for a fight if it becomes law.

5. Brexit

The UK and France just engaged in an unusual maritime tussle over new Brexit trade guidelines. The conflict revolved around the self-governing British island of Jersey, just 14 miles off the French coast. France is not pleased that, due to the hasty trade deal struck between the UK and the European Union in December, its fishing boats must now provide paperwork to operate there. British media reported that the UK had sent two gunboats to the area amid reports that French fishing boats had launched a protest. France, in turn, announced it was sending navy ships to monitor the situation. The UK said it didn’t want to escalate the situation, and the French boats eventually left. But it was another moment of unexpected drama as the region navigates the first few months of a post-Brexit reality.

BREAKFAST BROWSE

A longtime cast member is checking out of ‘Grey’s Anatomy’

This article does contain spoilers for the latest episode, so don’t say we didn’t warn you!

First official images from ‘Game of Thrones’ prequel ‘House of the Dragon’ released

Ahh, the costumes are just … *chef’s kiss.*

This tiny dinosaur hunted in the dark and heard better than an owl

Is it 66 million years old? Yes. Do we still want one as a pet? Also, yes. 

Applebee’s shorter menu is here to stay. Here’s what got cut

Fare thee well, BBQ brisket tacos and loaded potato soup.

Rome debuts hot pizza vending machine

How are the locals liking it? “It’s OK, but it’s not pizza.” Fair enough!

TODAY’S NUMBER

$1.8 billion

That’s how much India is spending on a parliament renovation, even as hospitals plead for help and Covid-19 patients die by the thousands. Prime Minister Narendra Modi has pushed for the renovations.

TODAY’S QUOTE

“He believed what was being fed to him.”

Joseph Hurley, a lawyer for alleged Capitol rioter Anthony Antonio, who said his client had “Foxitis” and “Foxmania” and believed lies about the 2020 election from Fox News.

TODAY’S WEATHER

Check your local forecast here>>>

AND FINALLY

What’ve you got there?

It’s nice to know cows appreciate good accordion playing just as much as anyone else. (Click here to view.)

Blog: DfE: Brexit stalled grammar schools inclusion monitoring – Schools Week

The government has claimed that Brexit hampered its monitoring of efforts to make grammar schools more inclusive, after admitting that the proportion of poorer pupils attending them rose by less than a percentage point in five years.

To blame the pandemic for disrupting the work of widening access to grammar schools is poor

Department for Education data shows that, as of January 2020, 7.5 per cent of grammar school pupils had been eligible for free school meals over the previous six years. In January 2015, that figure was 6.9 per cent. The national rate is over 20 per cent.

The DfE launched a £50 million-a-year selective school expansion fund in 2018. In exchange for expansion cash, schools had to put a plan in place to admit more poor pupils.

But Schools Week revealed last year that just 77 additional pupil premium places had been created in 14 of the 16 schools first awarded expansion money, despite the number of overall places in the same schools increasing by 367.

Also in 2018, the DfE signed a memorandum of understanding with the Grammar School Heads’ Association (GSHA), which included an agreement to report progress towards an “upwards trend of numbers of disadvantaged children being admitted to selective schools”.

But minutes obtained by Comprehensive Future show that only five meetings about the MOU have taken place, with little progress data shared.

The DfE claimed its meetings had been “interrupted by the need to reprioritise activity towards delivering Brexit and supporting the schools sector on Covid-19”.

Poorer pupil figures ‘shocking’

Comprehensive Future chair Dr Nuala Burgess said the latest figure for poorer pupils was “shocking” given “how much money has been thrown at selective schools to encourage outreach and widening access work”.

grammar schools

Dr Nuala Burgess

She added: “It seems clear that the DfE takes little interest in this work, and to blame the pandemic for disrupting the work of widening access to grammar schools is poor.”

Dr Mark Fenton, chief executive of the GSHA, acknowledged that meetings had been “a bit start-stop on the DfE’s part”, but said efforts by schools to become more inclusive had carried on “regardless”.

Fenton admitted that his organisation did not collect data on its members’ pupil premium rates “since it’s better to use official data collected through the annual school census”, and had not been asked to do so by the DfE.

But he cautioned against comparing grammar schools’ overall pupil premium rate with the national figure “since pupil premium children are not evenly distributed across the country”.

Meeting minutes do offer some examples of how grammar schools have changed their systems. Some have moved the admissions test to weekdays, while others have reduced the pass mark for disadvantaged pupils.

Fenton said grammar school intakes were getting “ever closer to matching the profile of their local area, but we are working to overcome deep-seated issues which begin years before children get anywhere near applying”.

Grammar schools turn to ‘test familiarisation’ scheme

The minutes also reveal that 29 grammars are now using an online “test familiarisation” programme hosted by software company Frog Education.

The pilot project, paid for by the GSHA, provides a portal and materials to get poorer pupils used to the test format and types of questions. The annual cost is £750 per school, with unlimited access for between 100 and 150 disadvantaged children per year.

The GSHA insisted that the familiarisation programme was not the same as tutoring, but Burgess said she was not convinced. “It begs the question: when does ‘familiarisation’ become ‘tuition’?” she asked.

“If 10 hours’ practice is good, isn’t there even more advantage for anyone who can pay for 15 hours, 20 hours or more?”

But Steve Holt from Frog Education told Schools Week the system was designed only to be used by disadvantaged children, and could not be accessed by paying customers.

Tim Harris, head of Colyton Grammar School in Devon, said the programme had contributed to an increase in the proportion of pupil premium children at the school from below 4 per cent to 9.2 per cent in five years.

He said the approach was not about tutoring, but rather “demystifying the entrance tests and the nature of the kind of school, making people realise that this is a school for everybody”.

The GSHA hopes to extend the programme to all its members.

The DfE said it hadn’t asked the GSHA to provide data on disadvantaged pupil attendance as this was already available through the census. It also said the information shared by grammar schools during the meetings was “consistent” with the terms of the MOU.

Blog: UK importers are still reeling from increased Brexit costs and delays – PCR – PCR-online.biz

New Government figures released 6 May revealed many businesses are still overwhelmed by the impact of Brexit. Over 39% of importers reported they are still struggling with new customs duties and 38.6% were battling with increased transport costs.

The international delivery specialist ParcelHero said the latest Office for National Statistics (ONS) Business Insights’ results, covering the period 5-18 April, show that there are still significant difficulties in importing goods from the EU post-Brexit. It warns that, inevitably, the increased costs will have to be passed on to consumers.

ParcelHero’s Head of Consumer Research, David Jinks M.I.L.T., said: ‘April’s figures on the importing and exporting challenges facing British businesses are pretty dire. The Government can no longer hide its head in the sands of Britain’s coastal borders. There was a huge flaw in the Government’s final trade deal struck just before Christmas, and it’s seemingly insoluble.

‘Under the Brexit so-called “free trade” deal, goods arriving in the UK from the EU that are sourced and manufactured in Europe don’t pay tariffs. But how many products are entirely sourced and made in a single area in today’s world of global supply chains? The answer is very few. Electronics incorporate components from across the globe, while clothing can include materials from many continents. That’s why importers are paying more duties, customers are finding unexpected charges on items ordered from EU traders, and transport costs are rising because of mounting delays and returns.

‘This latest ONS Business Insights assessment, in the section entitled “Exporting and Importing Challenges”, reveals that 41% of importers are still struggling with the nightmare of increased paperwork. Changing tax rules and new proof of origin forms have proved difficult for many companies, both large and small.

‘Additionally, a slew of other Brexit difficulties had not been ironed out by April. Nearly 7% of importers said their suppliers were still not Customs ready, while 4.5% of British importers said their regular suppliers had stopped trading with the UK entirely in April, as the full impact of Brexit bureaucracy hit home.

‘Smaller importers have been hit disproportionately by the cost of Brexit. In April, 25.3% of SME importers experienced disruption at UK borders, as opposed to just 14.4% of large companies, and 38% of smaller companies wrestled with transport costs, as opposed to 30.5% of larger importers.

‘The basic problem is that EU manufacturers and sellers are no longer fighting to get their goods into the British market. The UK is no longer seen as an easy and profitable market. European transport companies hate the new duties, delays and the fact that goods are still being turned away at ports because of incomplete paperwork. Those companies that continue to serve the UK are increasing their prices to compensate.

‘Importers are bearing the brunt of these changes for now but, before long, these increased costs will have to be passed on to the beleaguered British shopper. The challenge of Covid may at last be subsiding but, for Britain’s retailers and manufacturers, the impact of Brexit is not going away.

‘Our fear is that there could be even worse to come. Let’s not forget that some of the most complex new EU border regulations have been postponed, unilaterally, by the UK Government. It remains to be seen what their impact might be on these already worrying import figures once they are imposed.

Read the latest edition of PCR’s monthly magazine below:

Like this content? Sign up for the free PCR Daily Digest email service to get the latest tech news straight to your inbox. You can also follow PCR on Twitter and Facebook.

Blog: UK gets new lung cancer drug under international scheme thanks to Brexit deal – Express

The nation was signed up to the US-led Project Orbis in January to work with other countries to review and approve promising cancer ­medicines quickly and efficiently. Hundreds of patients are now expected to benefit from the new post-surgery treatment.

The UK’s involvement was revealed by the Daily Express in October, when Health Secretary Matt Hancock announced “teaming up with the fastest regulators in the world to get safe licences as fast as the science allows”.

He said at the time: “One of the benefits of Brexit will be faster access to life-saving treatments on the NHS.”

The other nations involved are Canada, Australia, Switzerland, Singapore, and Brazil.

The lung cancer drug – called Osimertinib – is made by AstraZeneca and sold under the brand name Tagrisso.

Given in tablet form, it was originally licensed to treat patients with mid and later-stage non-small cell lung ­cancer who carry a gene mutation called EGFR – which is around 12 percent of sufferers. But it has been extended to include those in early-stage disease after the cancer is surgically removed.

Mr Hancock said: “It is absolutely vital NHS patients have access to the most promising, ­cutting-edge treatments as quickly as possible.

“Leaving the EU ­presented us with the opportunity to join Project Orbis – a ­collaboration with the top regulators around the world – to speed up the time it takes to get new medicines to patients.

“I am delighted we are able to see the first results – a groundbreaking drug for lung ­cancer which will soon benefit hundreds of patients and I look forward to seeing what further ­innovations it will bring to the table.”

Project Orbis was launched by the US Food and Drug Administration in 2019 to streamline drugs reviews.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will make the final decision to authorise any medicines.

Chief executive Dr June Raine said: “We know that the earlier we can treat patients, the better their outcomes.

“The MHRA is cementing the UK’s global position at the centre of life ­sciences and healthcare access.”

Blog: French fishermen claimed Brexit deal was ‘win-win’ as Paris promised £26,000 in aid – Express

Jersey ‘taking threats from France very seriously’ says Gorst

Sign up to receive our rundown of the day’s

top stories

direct to your inbox

Invalid email

When you subscribe we will use the information you provide to send you these newsletters. Sometimes they’ll include recommendations for other related newsletters or services we offer. Our Privacy Notice explains more about how we use your data, and your rights. You can unsubscribe at any time.

French fishermen have caused alarm in Jersey’s waters this week, after descending on the Channel Island’s main port in protest to the new Brexit system. The Brexit deal stipulates that, for a fisherman to acquire a licence to fish in this area, they must prove they have a history of using Jersey’s waters. The French fishing boats claim new “technical” measures have been added to the criteria which were not run past the EU first — making the new rules “null and void”.

The 60 French boats withdrew this afternoon after discussions, but promised to return, while two Royal Navy vessels are to remain in the area as a “precautionary measure”.

In a show of support for the fishing industry, Paris briefly threatened to cut off the island’s power — Jersey receives 95 percent of its electricity from France — and accused the island of acting too slowly to address the licencing issues.

French fishermen also warned they could blockade the main port of St Helier.

The spokesman for fishermen from Normandy, Hugo Lehuby, told Reuters: “We’re getting deeper into deadlock. Either this gets resolved or retaliatory measures are taken.”

However, French fishermen were extremely relieved when the Brexit deal was signed just a few months ago.

French President Emmanuel Macron offered support to French fishermen after the Brexit deal was signed

French President Emmanuel Macron offered support to French fishermen after the Brexit deal was signe (Image: Getty)

Jersey: French boats protest in St Helier port waters

Speaking in December, French fishing officials welcomed the new accord which allowed them to continue fishing in British waters after January 1 — averting a “no deal” scenario.

Olivier Lepretre, President of the Fishing Committee for the northern Hauts-de-France region, told French outlet AFP: “It’s a huge relief for fishermen — it’s a win-win deal.

“We’re going to lose some of our quotas, which is annoying but it’s not a death knell.”

His vice-president Stephane Pinto also told France 3 TV: “The biggest worry for fishermen in Hauts-de-France, as well as the entire sector, was that we would no longer have access to British waters. That is no longer the case.”

Jean-Luc Hall, head of the national CNPMEM fisheries associations pointed out that French boats take 30 to 70 percent of their haul from UK waters.

READ MORE:  EU thought we’d cave on fish but Brexit is about fighting back COMMENT

Boris Johnson and Emmanuel Macron, along with the rest of the EU, agreed to the Brexit deal in December

Boris Johnson and Emmanuel Macron, along with the rest of the EU, agreed to the Brexit deal in December (Image: Getty)

He told AFP: “Even if it isn’t perfect, it seems we’ll still be able to work — this gives us a little bit of visibility.”

Access to UK fishing waters had been a major sticking point throughout the Brexit negotiations, but both sides seemed content when an agreement reached just before Christmas saw the EU agree to give up 25 percent of current quotas over the next five-and-a-half years.

The UK is expected to have access to an additional £145million of fishing quota by June 2026.

Once the five-year period is up, the EU will negotiate how much fish it could take from British waters on an annual basis — if it’s not satisfied, it can impose economic measures against the UK.

Yet, the UK will also be well within its rights to remove EU access to UK waters.

DON’T MISS
France’s failed legal bid to challenge Jersey and Guernsey’s UK links [INSIGHT]
Irish fishermen ‘fear influx of French vessels if UK waters protected’ [EXPLAINED]
Brexit panic: Why Ireland’s fishermen fear ‘unmitigated disaster’ [EXPOSED]

EU countries which rely on access to UK fishing waters for the fishing industry

EU countries which rely on access to UK fishing waters for the fishing industry (Image: Express)

French fishermen protested the Brexit deal this week

French fishermen protested the Brexit deal this week (Image: Getty)

To assist with the transition, the French Government confirmed it would support fishermen and fishmongers with individual aid after the Brexit deal was signed.

The French fisheries ministry said: “Fishermen and wholesalers will be able to benefit from a flat-rate aid of up to €30,000 (£26,000) depending on their dependence on products caught in British waters.”

This compensation is expected to help ease the turnover losses of companies which depended on UK waters.

There is also investment aid under a recovery plan and the EU’s “fleet exit plan”, for vessels who were dependent on UK waters which now want to stop activity.

Downing Street sent two Royal Navy vessels to patrol Jersey waters

Downing Street sent two Royal Navy vessels to patrol Jersey waters (Image: PA)

Yet, it’s clear that French fishermen are no longer content with the measures Jersey has put in place for its fishing waters by their protest this week.

Prime Minister Boris Johnson has reiterated his “unequivocal support” for the island, while Jersey’s External Relations Minister Ian Gorst said discussions to resolve the tensions today were “positive”.

Mr Gorst added: “We agreed that all sides remain committed to engaging with our partners in the EU and France to resolve the concerns arising from the issuing of fishing licences under the Trade and Co-operation Agreement, which led to today’s protest.”

The European Commission said it is “engaging in good faith” with the UK to solve the dispute.

The two large French vessels sent in to support the fishermen were reportedly seen leaving the area today, along with the protesting French fishing boats.

Blog: Aclaris Therapeutics Reports First Quarter 2021 Financial Results and Provides a Corporate Update – GlobeNewswire

  •  Data from Phase 2a Trial of ATI-1777 for Moderate to Severe Atopic Dermatitis Expected in Second Quarter of 2021
  • Advancing ATI-450 with Planned Initiation of Phase 2b Trial for Moderate to Severe Rheumatoid Arthritis in Second Half of 2021
  • Advancing ATI-450 into Two Additional Indications: Hidradenitis Suppurativa and Psoriatic Arthritis
  • Expands Scientific Advisory Board

WAYNE, Pa., May 07, 2021 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the first quarter of 2021 and provided a corporate update.

“We’re very pleased with the progress of our novel immuno-inflammatory drug development pipeline and look forward to reporting data from our Phase 2a trial of ATI-1777 in the second quarter of 2021,” said Dr. Neal Walker, President & CEO of Aclaris. “ATI-1777 is our second development program generated by KINect, our proprietary drug discovery platform. After generating proof of mechanism in inhibiting TNFα, IL1β and IL6 in our Phase 2a trial of ATI-450 in moderate to severe rheumatoid arthritis, we are planning to move ATI-450 forward with a Phase 2b trial in moderate to severe rheumatoid arthritis in the second half of 2021 and planning to initiate two additional trials of ATI-450 in hidradenitis suppurativa and psoriatic arthritis.”

Research and Development Highlights:

The global COVID-19 pandemic continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its research and development and regulatory activities listed below.

  • ATI-450, an investigational oral small molecule MK2 inhibitor compound:
    • ATI-450-RA-201: A Phase 2a, multicenter, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled clinical trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in 19 subjects with moderate to severe rheumatoid arthritis. The trial consisted of a 12-week treatment period and a 4-week follow-up period. Two subjects withdrew from the trial during the treatment period, one in the treatment arm and one in the placebo arm.
      • Final per-protocol analysis, which consisted of 17 subjects who completed the treatment period (15 in the treatment arm and two in the placebo arm), confirmed that ATI-450 demonstrated durable clinical activity, as defined by a marked and sustained reduction in DAS28-CRP and improvement of ACR20/50/70 responses over 12 weeks.
      • Overall, ATI-450 was generally well tolerated. There were no treatment-related serious adverse events and all adverse events were mild to moderate. There was one non-treatment-related serious adverse event (COVID-19) reported in the 4-week follow-up period of the trial in a subject who was no longer receiving treatment. The subject withdrew during the 4-week follow-up period of the trial.
    • Aclaris intends to progress ATI-450 into a Phase 2b trial in moderate to severe rheumatoid arthritis in the second half of 2021.
    • As part of its planned expansion of its Phase 2 immuno-inflammatory clinical development programs, Aclaris also plans to progress ATI-450 into Phase 2 trials in hidradenitis suppurativa and psoriatic arthritis.
  • ATI-1777, an investigational topical “soft” Janus Kinase (JAK) 1/3 inhibitor compound:
    • ATI-1777-AD-201: An ongoing Phase 2a, multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to investigate the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in 50 subjects with moderate to severe atopic dermatitis. The primary endpoint is the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 4.
      • Enrollment in this trial was completed in March 2021.
      • Data from this trial are now expected in the second quarter of 2021.
  • ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
    • Currently being developed as a potential treatment for T-cell mediated diseases such as psoriasis and/or inflammatory bowel disease.
    • Submission of Investigational New Drug Application is expected in the second half of 2021.

Aclaris is also expanding its Scientific Advisory Board with the addition of Dr. Philip Mease. Dr. Mease, a rheumatologist, currently serves as a Director of the Division of Rheumatology Clinical Research at the Swedish Medical Center/Providence St. Joseph Health and is a Clinical Professor at the University of Washington in Seattle. His major clinical and research focus is psoriatic arthritis and axial spondyloarthritis.

Financial Highlights:

Liquidity and Capital Resources

As of March 31, 2021, Aclaris had aggregate cash, cash equivalents and marketable securities of $142.7 million compared to $54.1 million as of December 31, 2020. The primary factors for the change in cash, cash equivalents and marketable securities during the three months ended March 31, 2021 included:

  • Net proceeds of $103.3 million from a public offering in January 2021 in which Aclaris sold 6.3 million shares of common stock.
  • Net cash used in operating activities of $12.2 million resulting from net loss of $28.8 million and changes in operating assets and liabilities of $2.9 million, partially offset by non-cash adjustments of $19.4 million which was primarily related to a $16.4 million charge for the revaluation of contingent consideration.

Aclaris anticipates that its cash, cash equivalents and marketable securities as of March 31, 2021 will be sufficient to fund its operations through the end of 2023, including estimated costs for the Phase 2b trial of ATI-450 for moderate to severe rheumatoid arthritis and the planned expansion of its Phase 2 immuno-inflammatory clinical development programs for hidradenitis suppurativa and psoriatic arthritis, without giving effect to any potential business development transactions or financing activities.

Financial Results

First Quarter 2021

  • Net loss was $28.8 million for the first quarter of 2021 compared to $15.6 million for the first quarter of 2020.
  • Total revenue was $1.8 million for the first quarter of 2021 compared to $1.4 million for the first quarter of 2020.
  • Research and development (R&D) expenses were $7.8 million for the quarter ended March 31, 2021 compared to $7.7 million for the prior year period.
    • The quarter-over-quarter increase of $0.1 million was primarily the result of continued investment in the further development of Aclaris’ immuno-inflammatory drug development pipeline, including ATI-450, ATI-1777 and ATI-2138, partially offset by a reduction in spend for legacy dermatology assets and personnel costs.
  • General and administrative (G&A) expenses were $4.8 million for the quarter ended March 31, 2021 compared to $6.2 million for the prior year period.
    • The quarter-over-quarter decrease of $1.4 million was primarily the result of lower personnel and non-cash stock-based compensation expenses.
  • Revaluation of contingent consideration charges related to the Confluence acquisition was $16.4 million for the quarter ended March 31, 2021 compared to $1.8 million for the prior year period.
    • The quarter-over-quarter increase in contingent consideration of $14.7 million primarily resulted from updates to probability of success and estimated future sales level assumptions following the completion of a Phase 2a clinical trial of ATI-450 in subjects with moderate to severe rheumatoid arthritis.

About Aclaris Therapeutics, Inc.

Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit http://www.aclaristx.com.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Aclaris’ drug candidates, including the availability of data from its clinical trials and timing for regulatory filings, and its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations through the end of 2023. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, Aclaris’ ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.



Aclaris Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except share and per share data)

    Three Months Ended
    March 31,
       2021        2020  
Revenues:            
Contract research   $ 1,535     $ 1,189  
Other revenue     242       218  
Total revenue     1,777       1,407  
             
Costs and expenses:            
Cost of revenue (1)     1,202       1,269  
Research and development (1)     7,838       7,677  
General and administrative (1)     4,827       6,200  
Revaluation of contingent consideration     16,439       1,767  
Total costs and expenses     30,306       16,913  
Loss from operations     (28,529 )     (15,506 )
Other income (expense), net     (225 )     178  
Loss from continuing operations     (28,754 )     (15,328 )
Loss from discontinued operations           (258 )
Net loss   $ (28,754 )   $ (15,586 )
Net loss per share, basic and diluted   $ (0.57 )   $ (0.37 )
Weighted average common shares outstanding, basic and diluted     50,337,807       41,618,429  
             
(1) Amounts include stock-based compensation expense as follows:            
             
Cost of revenue   $ 247     $ 260  
Research and development     876       816  
General and administrative     1,552       2,377  
Total stock-based compensation expense   $ 2,675     $ 3,453  



Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands, except share data)

             
       March 31, 2021      December 31, 2020
             
Cash, cash equivalents and marketable securities   $ 142,657   $ 54,131
Total assets   $ 161,399   $ 70,784
Total current liabilities   $ 14,505   $ 14,874
Total liabilities   $ 49,105   $ 33,134
Total stockholders’ equity   $ 112,294   $ 37,650
Common stock outstanding     52,081,729     45,109,314


Aclaris Contact

investors@aclaristx.com

Blog: MIX TELEMATICS LTD : Regulation FD Disclosure, Financial Statements and Exhibits (form 8-K) – marketscreener.com

Item 7.01. Regulation FD Disclosure.

This report contains a copy of the submission to the Johannesburg Stock Exchange
by MiX Telematics Limited (the “Company”) announcing the date of fourth quarter
and fiscal year 2021 conference call and webcast. The submission is furnished as
Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in this Item 7.01, including the information contained
in the presentation furnished as Exhibit 99.1 hereto, is being “furnished” and
shall not be deemed to be “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to
the liabilities of that section, nor shall such information be deemed to be
incorporated by reference in any filing under the Securities Act of 1933, as
amended, or the Exchange Act, except as shall be expressly set forth by specific
reference in such filing

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit
No. Description of Exhibit

99.1 Submission to the Johannesburg Stock Exchange – MiX – date of

    fourth     quarter     and     fiscal     year     2021 conference call and
webcast.




——————————————————————————–

© Edgar Online, source Glimpses