Geron at ASCO: Durable Continuous Transfusion Independence with Imetelstat in MDS Phase 3

 

• Primary endpoint of 8-week transfusion independence (TI) significantly higher with imetelstat vs. placebo (P<0.001), with median TI duration approaching one year for imetelstat 8-week TI responders

• Statistically significant and clinically meaningful efficacy results achieved across key MDS subgroups: ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category

• Safety results consistent with prior imetelstat clinical experience

• Reduction in variant allele frequency (VAF) of genes commonly mutated in MDS and their correlation with clinical endpoints support disease-modifying potential of imetelstat

• Data support NDA submission which is on track for June 2023 to support potential U.S. commercial launch in first half of 2024

https://finance.yahoo.com/news/geron-announces-asco-presentation-reporting-193000539.html

AstraZeneca Says Imfinzi Data Shows Improved Response in Gastric Cancers

AstraZeneca said late Friday that interim analysis of the phase III study regarding its Imfinzi drug together with chemotherapy significantly improved pathologic complete response in gastric and gastroesophageal junction cancers.

The Anglo-Swedish pharma giant said that the trial demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of pathologic complete response in patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers.

The company said that the trial will continue as planned to assess overall survival data.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Says-Imfinzi-Data-Shows-Improved-Response-in-Gastric-Cancers-44028854/

Too Early to Invest In Nano-X?

 Nano-X Imaging (NNOX 17.45%) is a small-cap stock with a valuation of around $1 billion. Many investors are bullish about it and believe it may be the next big growth stock in healthcare. This year, its shares have jumped by 140%, making it one of the hottest stocks to own in 2023. 

But given the uncertain road ahead for the business and profitability nowhere in sight, is it too early to be jumping on this bandwagon?

There have been a couple of developments that have gotten investors excited about Nano-X of late. One is that healthcare behemoth Johnson & Johnson disclosed that it increased its investment in the X-ray company by nearly 62%. That's a big increase, but the investment is still worth less than $6 million today. That's a relatively small chunk for a business that last year reported profits of just under $18 billion. 

Another exciting piece of news for Nano-X investors came out in early May, when they learned that the U.S. Food and Drug Administration (FDA) provided 510(k) clearance for its multi-source Nanox.ARC X-ray system. The 510(k) clearance means the device is safe and effective, and that can now pave the way for the company to market the device. It also obtained clearance for the related cloud-based infrastructure, the Nanox.CLOUD.

The company says it will work with the FDA to obtain more regulatory clearances. The agency has cleared the device to be used in many areas, including hospitals, clinics, and imaging centers. Nano-X plans to offer it under what it says is "an innovative pay-per-scan business model."

It has been a long road for Nano-X to get where it is right now. The company first filed its 510(k) application for the Nanox.ARC system in 2021. And with the company focusing on a pay-per-use system and on making X-ray imaging affordable to patients, this means that even in the long run, Nanox may not exactly be a money-making machine.

A pay-per-use model can be a risky one, especially if companies have no financial incentive to use the devices (no large sunk costs or big investments to justify the use). For investors, that means the path to profitability and sustainability for the business may be a long one. 

The risk for dilution is high, given that Nano-X only received clearance for its X-ray system and isn't mass-producing it just yet. Costs will inevitably be much higher. Last quarter, for the period ended March 31, the company's operating loss totaled $12.1 million, and it used up $10.7 million in cash to fund its day-to-day operating activities.

Nano-X has approximately $78 million in cash and marketable securities on its books, so it can manage that level of cash burn, potentially for years. But as the business inevitably spends more money on investing activities, such as building its devices and scaling up operations, its expenses are sure to spike.

And without a big source of revenue to rely on -- last quarter, Nano-X generated $2.4 million in revenue from teleradiology services -- its cash burn could worsen. That may lead to the business turning to stock offerings and debt to help grow its operations.

There's been plenty of hype around Nano-X stock this year, but the fundamentals simply aren't there yet to suggest that the business will be in good shape in a few years. It has taken a while for the company just to get to this point, obtaining clearance for its multi-source X-ray system. The hard part will be producing the devices at scale, getting them to customers, and then having them use them. How that will play out and how strong demand will be is a big question mark moving forward.

Assuming that, because Johnson & Johnson invested in the business, it is a safe one to own is also a risky proposition. The healthcare giant has deep pockets, and it's a low-risk move for the company that potentially has lots of upside. It can afford to make such an investment -- retail investors who don't have billions at their disposal can't.

Nano-X remains a speculative buy and is only suitable for investors who feel comfortable taking on significant risk and the possibility of significant losses. Nano-X has a lot of work ahead to prove that it can be a good investment, and the safest thing to do right now is to steer clear of the stock until it can at least demonstrate strong demand for its devices.

https://www.fool.com/investing/2023/06/01/is-it-too-early-to-invest-in-nano-x-imaging/

FibroGen upped to Buy from Hold by Stifel

 Target to $32 from $23

https://finviz.com/quote.ashx?t=FGEN&p=d

AI cost nearly 4,000 people in the U.S. their jobs: Challenger

 Artificial intelligence (AI) cost several thousand people their jobs in May, according to Challenger, Gray & Christmas. 

In its monthly report released Thursday, the firm said U.S. employers cited AI as the reason for 3,900 of the layoffs, roughly 4.9% of May’s job cuts.

Challenger, Gray & Christmas had never had AI listed as an option prior to Thursday’s publication, according to Business Insider. 

In May, U.S. companies said over 80,000 jobs would be eliminated, the report found. Those cuts brought the total number of job cuts announced by U.S. employers since the start of 2023 to about 417,500. 

The Challenger, Gray & Christmas report said business closure was the most common reason in May for layoffs, resulting in 19,600 losing jobs. Behind that was "market/economic conditions" for about 14,600 and "no reason provided" for 12,900, according to the report.

During the five months of 2023, economic conditions have prompted the most announced job cuts, cited as the reason for nearly 206,300, according to the outplacement firm.

The 417,500 layoffs announced this year marked the "highest January-May total since 2020, when 1,414,828 cuts were recorded," Challenger, Gray & Christmas said. 

With the field of AI becoming increasingly hot and more AI-powered tools becoming available, questions have arisen about how the technology will affect jobs. 

Earlier in the year, a Goldman Sachs report suggested some kind of AI automation may be used for about two-thirds of U.S. positions, with about 25-50% of their daily work potentially being done by the technology. The researchers behind the report also noted "most jobs and industries are only partially exposed to automation and are thus more likely to be complemented rather than substituted by AI," according to Goldman Sachs.

Jobs that previously hadn’t existed before AI could also develop as AI's use becomes more widespread, the report also suggested.  

Separately, the World Economic Forum recently found that 50% of companies foresee AI will "create job growth" and 25% think it will "create job losses."

https://www.foxbusiness.com/economy/ai-cost-nearly-4000-people-us-their-jobs-report-says

FBI To Finally Hand Over Biden Corruption Docs Under Threat Of Contempt

 Rather than face a potential contempt of Congress vote in the GOP-controlled House, the FBI has agreed to hand over a subpoenaed document from the Biden family investigation which a whistleblower says contains allegations that Joe Biden, when he was VP, engaged in a bribery scheme to change US policy in return for $5 million to his family businesses.

Once the existence of the document was made known, Sen. Chuck Grassley (R-IA) demanded to see it, followed by a subpoena from House Oversight Committee Chairman James Comer (R-KY).

FBI Director Christopher Wray indicated as recently as Wednesday that he wouldn't turn over the document, but would allow lawmakers to come to the FBI and read it in person. According to Just the News, however, a deal was struck late Thursday for the FBI to bring the document to the Capitol.

"Chairman Comer will receive a briefing from the FBI and review the document on Monday," his committee told JTN. "Chairman Comer has been clear that anything short of producing the FD-1023 form to the House Oversight Committee is not compliance with his subpoena. This unclassified record contains pages of details that need to be investigated further by the House Oversight Committee."

The FBI told Just the News that it wanted to accommodate Congress, while maintaining sensitive confidential human source information which is often recorded in memos before it can be corroborated. In other words, according to the FBI 'it might be fake news!'

"Director Wray offered to provide the Committee’s Chairman and Ranking Member an opportunity to review information responsive to the subpoena in a secure manner to accommodate the committee, while protecting the confidentiality and safety of sources and important investigative sensitivities," said the bureau. "The FBI has continually demonstrated its commitment to working with the Committee to accommodate its request, from scheduling briefings and calls to now allowing the Chair to review information in person. The FBI remains committed to cooperating with the Committee in good faith."

The bureau also cautioned that FD-1023 forms  are “used by FBI agents to record unverified reporting by a confidential human source. Documenting the information does not validate it, establish its credibility, or weigh it against other information verified by the FBI. -Just the News

"Revealing unverified or possibly incomplete information could harm investigations, prejudice prosecutions or judicial proceedings, unfairly violate privacy or reputations, create misimpressions in the public, or potentially identify individuals who provide information to law enforcement, placing their physical safety at risk," the agency statement continued.

They didn't seem to mind creating 'misimpressions in the public' when they launched the Trump-Russia investigation despite knowing that the Steele Dossier was a complete fabrication.

https://www.zerohedge.com/political/fbi-finally-hands-over-biden-corruption-docs-under-threat-contempt

Kentucky Derby host Churchill Downs halts track for 'top to bottom review' after horse deaths

 Churchill Downs Inc. (CHDN), which hosts the famed Kentucky Derby, said late Friday it is moving its current spring and summer racing meets to Ellis Park, in Henderson, Ky., and halting racing operations at its Churchill Downs Racetrack in Louisville starting Wednesday. "Churchill Downs Racetrack has seen an unusual number of horse injuries over the previous month resulting in 12 equine fatalities," the company said. After internal reviews and investigations conducted by racing authorities, it has not identified the causes or discerned a pattern to link the deaths, it said. Churchill Downs decided to relocate the meets "out of an abundance of caution," it said. "Despite our best efforts to identify a cause for the recent horse injuries, and though no issues have been linked to our racing surfaces or environment at Churchill Downs, we need to take more time to conduct a top-to-bottom review of all of the details and circumstances so that we can further strengthen our surface, safety and integrity protocols," Churchill Downs Chief Executive Bill Carstanjen said in a statement. Live racing at Churchill Downs will be conducted as scheduled this weekend, the company said. Shares of Churchill Down rose 0.3% in the extended session Friday after ending the regular day up 3.3%.

https://www.morningstar.com/news/marketwatch/202306021064/kentucky-derby-host-churchill-downs-halts-louisville-racetrack-as-it-conducts-top-to-bottom-review-after-horse-deaths