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Wednesday, February 8, 2023

Titan Med Updates Strategic Review Process

 Titan Medical Inc. (the “Company” or “Titan”) (Nasdaq: TMDI; TSX: TMD) today provided an update on the previously announced review and evaluation of strategic alternatives.

As previously disclosed on November 30, 2022, Titan’s Board of Directors determined that it was in the best interests of the Company and its stakeholders to undertake a review and evaluation of strategic alternatives and engaged Raymond James as the Company’s financial advisor.

At the direction of the Board, Titan’s financial advisor and members of Titan’s leadership team conducted a comprehensive outreach to over 40 potential counterparties, engaged in a number of management presentations and cooperated in confidential due diligence reviews by a subset of the potential counterparties. Unfortunately, none of the parties expressed an interest in acquiring the Company’s business and none chose to submit a proposal despite numerous extensions by the Company to the Board imposed process deadline to provide interested parties additional time and access. The specialized nature of the Company’s technology and the time to bring a product to market presented a smaller pool of potentially interested parties. A number of the parties cited the stage and focus of the Company’s technology development, the party’s financial circumstances, and a priority focus on the party’s own current business operations. Furthermore, the current economic environment and market conditions continue to provide significant challenges to potential acquirers, strategic partners and investors.

Accordingly, given the results and response of the strategic review process, the Board has determined to prioritize the sale of all or a portion of the Company’s assets, including its intellectual property portfolio of over 235 patents and patent applications. While the Company continues to seek alternatives, effective immediately, the Company will initiate further cost-cutting measures including a layoff of 48 employees at the Chapel Hill operations of the Company’s wholly owned subsidiary, which includes all employees furloughed on December 6, 2022. With these cuts, the Company’s remaining 18 employees will focus on i) supporting a potential strategic transaction including a sale of the Company’s assets; ii) continuing to complete deliverables pursuant to certain contractual development and supply obligations; iii) maintaining its intellectual property portfolio; and iv) continuing corporate administrative and compliance obligations. Having regard to its working capital limitations, the Company has halted all expenditures related to the development of its Enos™ single-access RAS system, including work on the investigational device exemption (IDE) filing with the U.S. Food and Drug Administration (FDA). The Company will consider further cost-cutting measures, including further reductions in workforce, as needed, based on determinations that it will make in consultation with its advisors and having regard to an ongoing strategic review process.

IRS urges millions of taxpayers to delay filin

 The Internal Revenue Service is telling millions of taxpayers who received special state tax refunds or payments to delay filing their 2022 taxes.

“There are a variety of state programs that distributed these payments in 2022 and the rules surrounding them are complex,” the IRS said in a statement. “We expect to provide additional clarity for as many states and taxpayers as possible next week.”

The IRS said it is “aware of questions” surrounding the relief efforts that were crafted by states in different ways and under different rules.

In California, for instance, residents who met the income, filing status and dependent requirements received checks ranging from $200 to $1,050 as part of the Middle Class Tax Refund (MCTR).

A spokesperson for the Franchise Tax Board (FTB) told Nexstar that as far as California state taxes are concerned, the MCTR is not taxable income, but noted that it “may be considered federal income,” leaving taxpayers in limbo and without official guidance from the IRS. According to the FTB, the refunds have benefitted more than 31 million California taxpayers and their dependents.

In Illinois, qualifying residents received one-time payments of up to $700 under the Illinois Family Relief Plan. Making matters more complicated, the checks consisted of two different rebates: one for individual income tax and another for property tax.

“For taxpayers uncertain about the taxability of their state payments, the IRS recommends they wait until additional guidance is available or consult with a reputable tax professional,” the IRS advised.

The two states are among 19 total that issued some type of special rebate or payment in 2022, according to the Associated Press. The full list consists of Alaska, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Maine, Massachusetts, Minnesota, New Jersey, New Mexico, Oregon, Rhode Island, South Carolina, and Virginia.

“While this is unusual, this kind of determination in the middle of tax season isn’t unprecedented,” Adam Brewer, a tax attorney with AB Tax Law in San Diego, tells Nexstar. “In 2021, the IRS exempted the first $10,200 of unemployment benefits received in 2020 after many Taxpayers had already filed their income taxes and reported the income as taxable. This mid-tax season rule change may be following that precedent.”

“We expect to provide additional clarity for as many states and taxpayers as possible next week,” the IRS said in the statement, adding that the agency doesn’t recommend trying to call the IRS or amending a previously filed 2022 return before guidance is issued.

https://thehill.com/changing-america/respect/poverty/3848404-irs-urges-millions-of-taxpayers-to-delay-filing/

Bayer hopes for swift resolution to Russia sunseed shipment delay

 

Germany's Bayer said on Wednesday it was continuing to supply agricultural products to Russia and hoped for a swift resolution to what it called a technical delay in the country's sunflower seed imports.

The Izvestia newspaper said on Monday that Western seed producers had suspended sunflower seed shipments to Russia and paused customers' bids for purchases, citing letters sent by Bayer, Swiss agrochemicals group Syngenta and seed firm Nuseed.

"As announced last year, Bayer continues to supply key agricultural products and solutions for farmers in Russia," Bayer said.

"At the moment, there are temporary delays in sunflower seed imports. We are hoping for an early resolution of the technical delay and for the timely import of seeds for the upcoming sowing campaign," the company told Reuters.

Russia's agriculture ministry said it did not see any risks for the 2023 sowing campaign and had already stocked up on what it needed, even if Western suppliers stopped shipments, Izvestia reported.

Russia and Ukraine are the world's largest sunflower oil exporters and sell millions of tonnes annually, much of it to the world's largest importer India.

https://www.marketscreener.com/quote/stock/BAYER-AG-436063/news/Bayer-hopes-for-swift-resolution-to-Russia-sunseed-shipment-delay-42926759/

Illumina fights EU order to divest Grail

 

U.S. life science company Illumina on Wednesday took its case to senior EU and national antitrust officials at a closed hearing to argue against an EU antitrust order that it divests cancer detection test maker Grail Inc.

Illumina had completed a takeover of Grail in August 2021, without securing European Union regulatory approval. The European Commission ordered Illumina in December to unwind the deal, three months after it had blocked the merger on concerns the deal would stifle innovation.

Illumina has said the EU competition enforcer should not have examined the case as the companies do not meet a revenue threshold stipulated by EU merger rules.

"We disagree that the Commission has jurisdiction to review the Grail transaction and believe that divestment is not proportional to the speculative harm the Commission has alleged," Illumina said in a statement ahead of the hearing.

"Any divestment order should be stayed until our appeal of the Commission's prohibition decision has been resolved," it said.

Companies usually take the opportunity at such hearings to persuade senior EU and national competition officials of the pro-competitive advantages of their deals.

Illumina has three appeals pending in Europe's top courts, against the EU enforcer's ruling that it jumped the gun by closing the deal without securing approval, the EU's subsequent veto, and the EU decision to examine the case in the first place.

https://www.marketscreener.com/quote/stock/ILLUMINA-INC-9659/news/Illumina-fights-EU-order-to-divest-Grail-42931619/

BioRestorative Poised To Receive European Patent For ThermoStem Program

 The European Patent Office has issued a notice of allowance for a patent application related to BioRestorative Therapies Inc's 

 metabolic ThermoStem program. 

The notice of allowance was issued on February 6, 2023.

What Happened: Claims granted under the new patent cover implantable three-dimensional scaffolds and brown adipocytes derived from human brown adipose-derived stem cells. 

The therapeutic combination of scaffolds as a delivery system and brown adipose-derived stem cells provides the ability to deliver metabolically active cells. 

Why It Matters: The therapeutic benefits of using brown adipose have been demonstrated in various models. Certain companies that use encapsulation technology coupled with cells have shown promising clinical results in treating type 1 diabetes in their Phase 1/2 clinical trials.

"We are committed to the development of ThermoStem as a potential treatment for obesity and metabolic disorders, such as type 2 diabetes," said Lance Alstodt, the company's CEO. 

https://www.benzinga.com/general/biotech/23/02/30801427/exclusive-biorestorative-poised-to-receive-european-patent-for-thermostem-program

Google Shares Tumble After 'Bard' AI Glitch

 While every company is rapidly changing its name to XXXX.AI in order to garner some 'fad' multiple expansion, Alphabet shares are showing the downside of some of that over-exuberance.

Reuters reports that Google published an online advertisement in which its much anticipated AI chatbot BARD delivered inaccurate answers.

The tech giant posted a short GIF video of BARD in action via Twitter, describing the chatbot as a "launchpad for curiosity" that would help simplify complex topics.

Here's the ad...

In the advertisement, BARD is given the prompt:

"What new discoveries from the James Webb Space Telescope (JWST) can I tell my 9-year old about?"

BARD responds with a number of answers, including one suggesting the JWST was used to take the very first pictures of a planet outside the Earth’s solar system, or exoplanets.

This is inaccurate.

The first pictures of exoplanets were taken by the European Southern Observatory’s Very Large Telescope (VLT) in 2004, as confirmed by NASA.

The falsehood will raise further questions about the accuracy of search engines and of AI-generated answers to humans’ questions.

GOOGL shares have plunged over 3% in the pre-market after this headline hit...

Fears have been raised about inaccuracies generated by artificial intelligence systems which are not easily spotted by humans.

It seems the AI is more A than I for now...

https://www.zerohedge.com/markets/google-shares-tumble-after-bard-ai-glitch

Arrowhead's hep B plans in jeopardy

 Confirmation by Arrowhead that Johnson & Johnson is set to ditch the companies’ 2018 hepatitis B deal leaves investors in a quandary. On the one hand Arrowhead could soon have full rights to the asset in question, JNJ-3989, which J&J had put into three phase 2 trials. On the other the senior partner’s decision will not spur confidence in Arrowhead, whose stock is down 9% this week, and could embolden rivals. Arrowhead says it has not received a notice of termination, but confirmed that J&J was “deprioritising hep B broadly”. J&J apparently cannot sublicense JNJ-3989 without Arrowhead’s say-so, and the likeliest outcome is that the asset will soon revert to its originator, but Arrowhead says it will assess options once there is clarity in the coming weeks. Wells Fargo analysts, who cover Ionis, suggest that J&J’s decision might have been spurred by data on Ionis’s GSK-partnered bepirovirsen, which they say has demonstrated greater efficacy than all phase 2 siRNA compounds. “We do not know where JNJ-3989 will ultimately end up,” Arrowhead told this week’s quarterly analyst call. At least the $175m up-front fee plus J&J’s sunk R&D costs are effectively money in the bank.

RNA-directed clinical-stage hepatitis B projects
ProjectCompanyMechanismStatusHBsAg reduction (log10 IU/ml)
Bepirovirsen (GSK3228836)GSK/ IonisAntisense oligoPh3 (B-Well 1 & 2)2.65-2.95 @wk24*
VIR-2218 (ALN-HBV02)Vir/ AlnylamsiRNAPh2 (March & others)1.89-2.40 @wk24
ARO-HBV (JNJ-3989)Arrowhead (J&J)siRNAPh2 (Octopus, Penguin & others)1.75-2.22 @wk24
AB-729Arbutus BiopharmasiRNAPh21.82-1.99 @wk24
RG6346 (DCR-HBVS)Roche/ Novo Nordisk (ex Dicerna)siRNAPh2 (no ct.gov entry)1.39-1.83 @wk16**
*In phase 2; **in phase 1. Source: clinicaltrials.gov & Wells Fargo.

https://www.evaluate.com/vantage/articles/news/snippets/arrowheads-hep-b-plans-jeopardy