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Tuesday, September 12, 2023

Eiger to Discontinue Chronic Hepatitis Delta Study, Ends Licensing Talks

 Eiger BioPharmaceuticals said it is discontinuing the company's phase 3 study to treat peginterferon lambda in patients with chronic hepatitis delta and has ceased active discussions for a worldwide license of the treatment.

The commercial-stage biopharmaceutical company said its decision is based on the Data Safety Monitoring Board, which recommended the discontinuation following a quarterly safety review.

Four patients with hepatobiliary events resulted in liver decompensation during the LIMT-2 study, the company said.

"We will work closely with the Food and Drug Administration and our investigators to conduct an orderly termination of the LIMT-2 study in the interest of patient safety," Chief Executive David Apelian added.

https://www.marketscreener.com/quote/stock/EIGER-BIOPHARMACEUTICALS-26727607/news/Eiger-BioPharmaceuticals-to-Discontinue-Chronic-Hepatitis-Delta-Study-Ends-Licensing-Talks-44827256/

KKR Is Said to Plan Kokusai Electric IPO at $2.7 Billion Value

 Private equity firm KKR Group plans to list Kokusai Electric Corp.’s shares in Tokyo as early as October at a valuation north of ¥400 billion ($2.7 billion), a person familiar with the matter said.

KKR will float a portion of the shares it owns in the former Hitachi Ltd. operations on the Tokyo Stock Exchange, the person said, asking not to be named as the talks are not public. While it’s not yet clear how much equity will be sold to investors, the initial public offering would raise roughly $540 million if the company sold a 20% stake.

Recent listings in Tokyo include Rakuten Bank Ltd.’s $623 million initial public offering in April, the country’s largest since SoftBank Group Corp.’s telecom unit SoftBank Corp. listed in 2018.

A representative from KKR declined to comment on Wednesday. A representative from Kokusai Electric could not immediately be reached for comment.

Kokusai Electric’s IPO preparations, which were reported earlier by the Nikkei, come as policymakers see semiconductors as key to national security, with equipment used to process silicon wafers critical for artificial intelligence and supercomputers.

California-based semiconductor equipment maker Applied Materials Inc. struck a deal to buy the smaller Tokyo-based Kokusai Electric in 2019, but the deal was scuttled after it failed to win approval from Chinese regulators. Both companies supply the world’s biggest chipmakers such as Samsung Electronics Co., Taiwan Semiconductor Manufacturing Co. and Intel Corp.

Mounting costs to pack more transistors onto slivers of silicon have been spurring chip gear and materials makers to pool their resources. But merger talks have often been frustrated by antitrust regulators and concerns about a single company holding sway over technologies with possible military applications.

The Qatar Investment Authority acquired a minority stake in the company, which was spun out of Hitachi Kokusai Electric after KKR bought the mobile phone and wireless equipment manufacturer in a tender offer in 2017.

Lyra: Positive Topline Results in Phase 2 Study of Treatment of Chronic Rhinosinusitis

 Study demonstrates statistically significant and clinically relevant improvements in 3 Cardinal Symptoms and SNOT-22 scores at 24 weeks

Statistically significant improvements in efficacy were observed as early as 2 weeks

Primary endpoint met with no serious adverse events observed

LYR-220, Lyra’s second product candidate, is a long-acting anti-inflammatory therapy in development for CRS patients with and without polyps who have recurrent symptoms despite prior ethmoid sinus surgery

Conference call today at 8:00 a.m. ET.

Lyra will host a conference call and webcast on Tuesday, September 12 at 8:00 a.m. ET to discuss the topline results of the BEACON study.

To listen online via webcast, please visit: https://edge.media-server.com/mmc/p/xfx5b2kt. The webcast and accompanying slides will be archived and available at https://investors.lyratherapeutics.com.

To participate in the conference call by telephone, please register using this online form: https://register.vevent.com/register/BI5027ff27ec2f477cb5cdb98957d840d2.

https://finance.yahoo.com/news/lyra-therapeutics-announces-positive-topline-110000415.html

Avalo to sell asset for congenital disorder treatment

Avalo Therapeutics, Inc. (Nasdaq: AVTX), today announced it entered into a purchase agreement (the Purchase Agreement) with AUG Therapeutics, LLC (AUG) to sell its rights, title and interest in, assets relating to AVTX-801 (D-galactose), AVTX-802 (D-mannose) and AVTX-803 (L-fucose) (collectively, the 800 Series).

AUG will pay an upfront payment of $150,000, as well as, for each compound, make a contingent milestone payment of $15,000,000 (for a potential aggregate of $45 million) if the first Food and Drug Administration (FDA) approval is for an indication other than a Rare Pediatric Disease (as defined in the Purchase Agreement), or up to 20% of certain payments, if any, granted to AUG upon any sale of any priority review voucher (PRV) granted to AUG by the FDA, net of any selling costs. Additionally, AUG will assume up to $150,000 of certain liabilities incurred prior to the date of the Purchase Agreement and assume all costs relating to the 800 Series from the date of the Purchase Agreement. The transaction is expected to close in the fourth quarter of 2023, subject to customary closing conditions, including obtaining certain third-party consents.

https://finance.yahoo.com/news/avalo-enters-agreement-divest-avtx-110000967.html

Sight Sciences Revenue Guidance for Q3 2023 and Updates Revenue Guidance for Full Year

 Sight Sciences, Inc. (Nasdaq: SGHT) (“Sight Sciences,” or the “Company”), an eyecare technology company focused on developing and commercializing innovative technology intended to transform care and improve patients’ lives, today announced third quarter 2023 revenue guidance and updated its revenue guidance for full year 2023.

Third Quarter 2023 Revenue Guidance
The Company expects third quarter 2023 total revenue to be in the range of $19.0 million to $20.0 million. While account retention remains high for our Surgical Glaucoma segment, the Company has seen reductions in new account additions, and expects year-over-year utilization to decrease in the third quarter, which the Company believes is primarily due to the transitory uncertainty for glaucoma customers caused by proposed local coverage determinations (“LCDs”). In June 2023, five of the seven Medicare Administrative Contractors (“MACs”) published LCDs that, if finalized as proposed, could identify many non-implantable micro-invasive glaucoma surgery (“MIGS”) procedures, including the Company’s surgical glaucoma technologies, as investigational and non-covered for Medicare beneficiaries in the states covered by these five MACs. The Company expects revenue from its Dry Eye segment to be slightly down sequentially primarily due to typical seasonality patterns, coupled with the evolution of the Company’s go-to-market strategy which emphasizes higher utilization within existing accounts as part of its focused reimbursement strategy. Thze Company is focused on building a higher utilization, recurring revenue business model with a durable repeat customer base and broad market access. While this is expected to result in relatively fewer new accounts added in the period, the Company has seen positive trends in recurring revenue from existing customers in the third quarter.

“We typically see a strong second quarter followed by a slower start to the third quarter given traditional seasonality patterns. While we had a strong second quarter prior to the LCD proposals, we have faced a lower cadence of new account additions and relatively flat utilization and we have not experienced the expected increase in commercial activity thus far in August and early September. While we are actively managing the proposed LCDs and their impacts on our business and customers, we believe that the ongoing uncertainty from the proposed LCDs has affected the ordering activity of certain customers in the third quarter. We expect this impact to continue until there is clarity on longer-term coverage by the MACs. We are taking steps intended to mitigate these effects and believe they will prove to be transitory if our products, especially our OMNI® Surgical System technology, maintain their current broad coverage upon finalization of the LCDs,” said Paul Badawi, Founder and Chief Executive Officer of Sight Sciences. “Notably, our account retention remains high, evidencing OMNI’s clinical importance to the glaucoma treatment paradigm. We expect that revenue will normalize and return to growth should the MACs clarify that OMNI procedures are to remain covered for Medicare beneficiaries in the affected jurisdictions.”

'Climate Emergency' Is A Hoax

  by Robert Williams via The Gatestone Institute,

More than 1,600 scientists, including two Nobel laureates, have signed a declaration saying that "There is no climate emergency."

The declaration is unlikely to get any attention from the mainstream media, unfortunately, but it is important for people to know about: the mass climate hysteria and the destruction of the US economy in the name of climate change need to stop.

"Climate science should be less political, while climate policies should be more scientific," states the declaration signed by the 1,609 scientists, including Nobel laureates John F. Clauser from the US and Ivar Giaever from Norway/US.

The statement adds:

"Scientists should openly address uncertainties and exaggerations in their predictions of global warming, while politicians should dispassionately count the real costs as well as the imagined benefits of their policy measures...

"The geological archive reveals that Earth's climate has varied as long as the planet has existed, with natural cold and warm phases. The Little Ice Age ended as recently as 1850. Therefore, it is no surprise that we now are experiencing a period of warming.

"Warming is far slower than predicted...

"The gap between the real world and the modeled world tells us that we are far from understanding climate change.

"Climate policy relies on inadequate models
Climate models have many shortcomings and are not remotely plausible as policy tools. They do not only exaggerate the effect of greenhouse gases, they also ignore the fact that enriching the atmosphere with CO2 is beneficial...

"Global warming has not increased natural disasters
There is no statistical evidence that global warming is intensifying hurricanes, floods, droughts and suchlike natural disasters, or making them more frequent. However, there is ample evidence that CO2 mitigation measures are as damag­ing as they are costly.

"Climate policy must respect scientific and economic realities
There is no climate emergency. Therefore, there is no cause for panic and alarm. We strongly oppose the harmful and unrealistic net-zero CO2 policy proposed for 2050. Go for adaptation instead of mitigation; adaptation works whatever the causes are."

Professor Steven Koonin, former Undersecretary for Science at the U.S. Department of Energy under the Obama administration, current professor at New York University, and fellow at the Hoover Institution, authored the 2021 bestseller, Unsettled: What Climate Science Tells Us, What It Doesn't, and Why It Matters. In it, he states that what the largely unreadable (for laymen) and complicated science reports say on climate change is completely distorted by the time their contents are filtered through a long line of summary reports of the research by the media and the politicians.

"There are abundant opportunities to get things wrong – both accidentally and on purpose – as the information goes through filter after filter to be packaged for various audiences... It's not only the public that is ill-informed about what the science says about climate..."

Koonin adds:

"Government and UN press releases and summaries do not accurately reflect the reports themselves... Distinguished climate experts (including report authors themselves) are embarrassed by some media portrayals of the science."

In a recent interview, Koonin noted that his colleagues' reactions to his book had been that he should not be telling the public or the politicians the truth about climate change.

"I was taught that you tell the whole truth [as a scientist]. And you let the politicians make the value judgments and the cost effectiveness trade-offs and so on," Koonin said. He noted as well the immorality of asking the developing world to cut down emissions when so many do not even have access to electricity, and the immorality of scaring the younger generations: 84% of American teenagers believing, as of January 2022, that if climate change is not addressed, "it will be too late for future generations, making some part of the planet unlivable."

Of course it would be helpful to research what can be done to relieve the problems brought about by man, such as the "hole in the ozone layer," which is now closing, but climate change is not an apocalyptic emergency and needs to be attended to without bringing devastation to the hundreds of millions of people already in extreme poverty.

The Biden administration, however, appears not to be concerned about the widespread poverty and massive starvation that will be caused by the unavailability of cheap and reliable energy in underdeveloped countries, or the inflation caused by the skyrocketing prices that are crushing Americans "barely able to afford one meal a day".

These are man-made problems, created by importing expensive (nearing $100 a barrel again) -- often dirtier -- oil from adversaries of the United States, such as Russia and Venezuela, instead of extracting it far less expensively at home. The Biden administration also does not seem concerned that so long as China and India keep burning coal – the Chinese Communist Party is permitting two new coal-power plants a week, easily cancelling out whatever benefits the US might be providing, and reportedly exceeding "all developed nations combined" in carbon emissions.

The Biden administration also does not seem concerned that it is killing wildlifesea life and the fishing industry by installing offshore wind turbines along the Atlantic seaboard, or that mandating electric vehicles will throw virtually the entire auto maintenance industry out of work (EVs do not need routine maintenance), or that lithium batteries not only explode but cost thousands of dollars to replace.

The administration even wants military equipment, such as tanks, to be electric, as if there were charging stations in the middle of foreign deserts in the event of a conflict. Moreover, according to NBC News, volcanoes, unimpressed with executive orders, "Dwarf Humans for CO2 Emissions."

The Biden administration does not even bother to act on its own climate findings: In March, the White House released a report about the impact of climate change on the US economy. "Its findings undermine any claims of an ongoing climate crisis or imminent catastrophe" Koonin wrote in July.

"The report's authors should be commended for honestly delivering likely unwelcome messages, even if they didn't make a show of it. The rest of the Biden administration and its climate-activist allies should moderate their apocalyptic rhetoric and cancel the climate crisis accordingly. Exaggerating the magnitude, urgency and certainty of the climate threat encourages ill-considered policies that could be more disruptive and expensive than any change in the climate itself."

But facts will not stop the Biden administration from forging ahead with its radical policies: "I don't think anybody can deny the impact of the climate crisis anymore," Biden, commenting on Hurricane Idalia, told reporters at the White House on August 30. "Just look around. Historic floods. I mean, historic floods. More intense droughts, extreme heat, significant wildfires have caused significant damage."

Never mind that much of climate change is apparently caused by sun flares, about which we can do nothing, and which, unlike commercial industries, do not offer grants; or that major wildfires are, ironically, exacerbated by "environmentalists" for refusing to let tinderbox brush be cleared lest the creatures there be disturbed other than by a wildfire.

Climate expert Bjørn Lomborg suggests that the trillions of dollars needed to address climate change might be put to better use:

"This isn't an argument to do nothing but just to be smarter. To ensure we can transition from fossil fuels, we need to ramp up research and development to innovate down the price of green energy. We should invest across all options including fusion, fission, storage, biofuel and other sources.

"Only when green energy is cheaper than fossil fuels will the world be able and willing to make the transition. Otherwise, today's energy prices are just a taste of things to come."

https://www.zerohedge.com/markets/climate-emergency-hoax

Cal. could increase minimum wage for fast food, health care workers

 Fast food and health care workers in California are slated to see major salary increases under a deal announced Monday between labor unions and the restaurant industry.

Under the new deal, restaurant chains with at least 60 national locations must pay their workers a minimum hourly wage of $20 as of April 2024, according to the Wall Street Journal. This would include most of the state's 500,000 fast food workers.

The deal was introduced into California's legislature Monday alongside a separate bill, which will increase the pay of about 455,000 health care workers, excluding doctors and nurses, to at least $25 per hour over the next decade, the Associated Press reported.

Both proposals will need to pass the state Legislature before a midnight Friday deadline and then be signed by Democrat Gov. Gavin Newsom before they are enacted. 

California McDonalds restaurant

An estimated 500,000 people work in the fast food industry in California, the most of any U.S. state. (Justin Sullivan/Getty Images / Getty Images)

Legislators will have to work quickly to get both bills passed by Friday, with the fast food bill expected to be heard in committee Tuesday morning. It is then expected to face a vote on the Senate floor vote by Thursday. If approved, it would face one last vote by the Assembly floor before heading to Newsom’s desk.

California's minimum wage is already among the highest in the country at $15.50 per hour and the new fast food deal shows the continued impact fast food industry workers have on wage negotiations.

"I think fast food cooks and cashiers have fundamentally changed the politics of wages in this country and have reshaped what working people believe is possible when they join together and take on corporate power and systemic racism," Service Employees International Union international president Mary Kay Henry told The Associated Press.

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Ingrid Vilorio, who works at a Jack In The Box in the San Francisco Bay Area, said the pay raise will help her family, who until recently was sharing a house with two other families to afford rent.

"A lot of us (in the fast-food industry) have to have two jobs to make ends meet. This will give us some breathing space," Vilorio, who also works as a nanny, told The Associated Press.

The new deal also amends a law passed that established state-appointed fast-food advisory councils to make policy recommendations over wage increases.

Panera Bread

The fast food proposal includes exceptions for restaurants that make and sell their own bread, such as Panera Bread. (iStock)

Under the new deal, the councils, composed of restaurant industry and labor leaders, will have the power to increase the $20 per hour minimum wage each year by up to a maximum of 3.5%.

Health care workers would see similar raises over the next few years, if the new proposal is approved.

According to the Associated Press, the salary increase for health care workers would rise gradually over the next 10 years, depending on where they work. Workers for large health care facilities and dialysis clinics could see at least a $23 per hour raise next year and to $25 per hour by 2026. Rural hospital workers would see their salaries increase to at least $18 per hour next year, with 3.5% increases each year until it reaches $25 per hour in 2033.

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Burger King

California's minimum wage is already among the highest in the country at $15.50 per hour. (Horacio Villalobos#Corbis/Corbis via Getty Images / Getty Images)

Workers at community clinics will have their salaries increase to at least $21 per hour in 2024 and rise again to $25 per hour in 2027, per the report. Salaries at all other covered health care facilities will jump to at least $21 per hour next year before moving up to $25 per hour by 2028.

"Everyone in the healthcare sector understands that we have a workforce crisis and that wages are the essential prerequisite for any solution," Service Employees International Union-California executive director Tia Orr told The Associated Press. "With this increase, more workers will join and stay in the healthcare workforce, and as a result, Californians will be safer and better cared for."

California Hospital Association president and CEO Carmela Coyle told The Associated Press that hospitals support the bill, in part, because it "ensures that wages for health care workers are set by the state, creating greater equity for all of California’s health care workforce."

https://www.foxbusiness.com/economy/california-could-increase-minimum-wage-fast-food-health-care-workers-new-proposals