Athersys Adds to Surge of Biotechs Filing for Bankruptcy, Sells to Healios

 Continuing the surge of biotech bankruptcies, Athersys filed for Chapter 11 on January 5, according to an SEC filing.  

All assets of the regenerative medicine and cell therapy company are being divested to its research partner, Healio, to the tune of $2 million in the form of a credit bid.  

The bankruptcy filing was not a surprise. After reporting disappointing results from its MultiStem pivotal trial in October 2023, the company said it was exploring options but, if unable to obtain adequate financing, would have to file for protection under bankruptcy laws to “conduct an orderly wind down of operations.” Athersys ended the third quarter of 2023 with only $1 million in cash, despite cost reduction efforts which included layoffs earlier in the year. Even a $10.4 million raise from investors and licensing partners in November was not enough to stave off Chapter 11.  

Healios will now take the reins on Athersys’ MultiStem program, which has been in development since 1994. The off-the-shelf therapy developed from adult stem cells was being studied in ischemic stroke—a program which was already partnered with Healios—traumatic injury and acute respiratory distress syndrome. The treatment was attractive as a stem cell option because it could be given to patients without prior immune suppression or tissue matching. 

Last year was a particularly tough one for biotech, presenting a record high number of bankruptcies, BioSpace found, with 41 biotech and pharma companies filing for bankruptcy. By comparison, 20 companies filed in 2022 and only nine in 2021. 

Experts identified the primary drivers for the surge as the post-COVID-19 economy, a shift toward data-driven financing activity, rising inflation rates and the rapid rate of innovation leading to increased competition in the space.  

“It’s a terrible market to get financing,” Ira Leiderman, managing director of the healthcare practice at Cassel Salpeter & Co., told BioSpace previously. “Companies are not getting financed, and they have no choice but to break the glass and push the bankruptcy button.” 

https://www.biospace.com/article/athersys-adds-to-surge-of-biotechs-filing-for-bankruptcy-sells-to-healios-/

GSK Puts $1.4B on the Line in Aiolos Acquisition to Boost Asthma Pipeline

 GSK on Tuesday announced it has entered into an agreement to buy Aiolos Bio in an effort to strengthen its pipeline of respiratory and inflammatory assets.

As per the acquisition agreement, GSK will pay Aiolos shareholders $1 billion upfront and will pledge up to $400 million in success-based regulatory milestones. The companies did not indicate when they expect to close the deal, but said that the transaction is subject to anti-trust clearance and other customary closing conditions.

At the core of the Aiolos buyout is AIO-001, a long-acting monoclonal antibody that targets the thymic stromal lymphopoietin (TSLP) cytokine, which according to the biotech’s website is a “validated driver of inflammation.” Blocking TSLP has been the “only biological approach that has demonstrated clinical benefit” in all types of moderate-to-severe asthma, Aiolos asserts.

AIO-001, which Aiolos licensed from Jiangsu Hengrui Pharmaceuticals outside of Greater China in August 2023, has the potential to be administered biannually, ultimately reducing the burden of asthma on patients’ daily lives. Preclinical studies and early clinical trials have validated the candidate’s mechanism of action and schedule, showing its promising efficacy and a long half-life, according to Aiolos' website.

Based on this potential, Aiolos launched just three months ago, in October 2023, with $245 million in Series A support. The funding round was backed by several big investors, including Atlas Venture, Bain Capital Life Sciences and Sofinnova Investments.

“Adding AIO-001, a potentially best-in-class medicine targeting the TSLP pathway, could expand the reach of our current respiratory biologics portfolio, including to the 40% of severe asthma patients with low T2 inflammation where treatment options are still needed,” Tony Wood, chief scientific officer at GSK, said in a statement Tuesday. 

As part of the Aiolos acquisition, GSK will be responsible for milestones and tiered royalties to Jiangsu Hengrui.

GSK is the fourth industry giant to jump into the dealmaking frenzy at the 42nd annual J.P. Morgan Healthcare Conference. On Monday, J&J put forward $2 billion to acquire La Jolla, Calif.–based Ambrx, which develops antibody-drug conjugates for cancer. The same day, Merck announced it was shelling out $680 million to buy Harpoon Therapeutics and its portfolio of T-cell engagers for various oncology targets.

Novartis likewise made three smaller plays on Monday, including a $250 million buyout of Calypso Biotech, bolstering its presence in immune diseases, and two RNAi license deals with Chinese biotech Shanghai Argo Biopharmaceutical, focusing on cardiovascular indications.

https://www.biospace.com/article/gsk-puts-1-4b-on-the-line-in-aiolos-acquisition-to-boost-asthma-pipeline/

Adicet Update, Strategic Priorities, Webcast

 Expanding clinical development of ADI-001 into autoimmune diseases following clearance of Investigational New Drug Application (IND); plan to initiate Phase 1 clinical study in 2Q 2024

Focusing enrollment on mantle cell lymphoma (MCL) in ongoing ADI-001 Phase 1 clinical trial given favorable complete response (CR) rate, durability, and safety

ADI-001 clinical update expected 2H 2024

ADI-270 IND submission in renal cell carcinoma expected in 2Q 2024

Updated cash runway into 2H 2025

The live webcast of the presentation can be accessed by registering under “Presentations & Events” in the investors section of the Company’s website at https://www.adicetbio.com. Upon registration, all participants will receive a confirmation email with a unique passcode to provide access to the webcast event. To participate via telephone, please join by dialing 888-788-0099 (domestic) or 312-626-6799 (international) and referencing the conference ID 918 2940 8885. An archived replay will be available for 30 days following the presentation. The archived webcast will be available on the Company's website beginning approximately two hours after the event.

https://www.businesswire.com/news/home/20240104790871/en/

Cutera prelims, investor meetings

 Cutera, Inc. (Nasdaq: CUTR) (“Cutera” or the “Company”), a leading provider of aesthetic and dermatology solutions, today announced certain preliminary, unaudited financial results for the year ended December 31, 2023. These results are unaudited, subject to the completion of the Company’s year-end financial reporting processes, reviews, audit, and potential adjustments that might result.

Based on these preliminary results, the Company expects:

• Revenue in the range of $211.5 million to $212.5 million for full-year 2023, vs. prior guidance of approximately $205 million.

• Cash and marketable securities of approximately $143 million as of the end of the fourth quarter, vs. prior guidance of approximately $135 million.

“I am pleased with the progress made by our team in stabilizing our business during the fourth quarter, allowing us to exceed our prior guidance for both revenue and cash. Relative to the third quarter, we delivered an uptick in skincare, an improvement in core business performance in international markets, and a similar level of AviClear revenue, offsetting softness in North America,” commented Taylor Harris, Chief Executive Officer of Cutera, Inc. “During the fourth quarter, our team made strong strides in targeted areas of operational improvement, including a significant reduction in open field service cases. Additionally, we completed our corporate restructuring, allowing for both an improved cost structure and better alignment of the team, and we successfully executed a limited commercial release of our optimized AviClear product and business model offering, laying the foundation for a broader launch as we move into 2024.”

Cutera management will host a series of individual investor meetings over the course of January 9 - 10, 2024 at the Nasdaq Offices at 505 Howard St, in downtown San Francisco.

https://www.businesswire.com/news/home/20240109564179/en/

NGM: Data from Ongoing Trial of NGM707 in Advanced Solid Tumors

 

• Encouraging findings in heavily pretreated patients in multiple solid tumor indications, including MSS colorectal cancer (CRC), in ongoing Phase 1 Part 1b study evaluating NGM707, a dual ILT2/ILT4 antagonist antibody, in combination with KEYTRUDA® (pembrolizumab)

• Aldafermin, an engineered FGF19 analog, has been granted Orphan Drug Designation by the FDA for the treatment of primary sclerosing cholangitis (PSC), a rare liver disease
  • Initiating design of a potential registrational trial of aldafermin in PSC and in discussion with the FDA on utilizing proposed surrogate endpoints with the goal of obtaining accelerated approval
  • Large body of clinical data, including from NGM Bio’s prior Phase 2 study in PSC, supports aldafermin’s differentiated potential to address the bile acid dysregulation underpinning PSC

• NGM120, a GDF15/GFRAL antagonist, has strong biologic rationale for the treatment of hyperemesis gravidarum
• Discussing design of an acceptable toxicology package to support clinical trials in hyperemesis gravidarum patients in ongoing dialogue with the FDA
• Recent evidence suggests this rare, devastating condition is linked to higher levels of, and greater sensitivity to, GDF15 during pregnancy
• NGM Bio is a long-time pioneer in elucidating GDF15 biology, including identifying its cognate receptor, GFRAL

https://www.globenewswire.com/news-release/2024/01/09/2806226/35057/en/NGM-Bio-Announces-New-Clinical-Data-from-Ongoing-Trial-of-NGM707-in-Advanced-Solid-Tumors-and-Outlines-Evolved-Strategy-for-Aldafermin-and-NGM120-to-Focus-on-Rare-Conditions-with-S.html

NexImmune's future in limbo as Gaithersburg biotech extends liquidation vote

 The company still needs shareholder approval to follow through on its plan to shutter operations and lay off most of its staff.

https://www.bizjournals.com/washington/news/2023/12/26/neximmune-liquidation-biotech-shareholder-vote.html

IRS: Venmo, PayPal And CashApp Freelancers Face 2024 Reporting Requirements

 After delaying for two years, the IRS is planning to finally start implementing its new 1099-K reporting requirement for anyone earning income via third-party payment apps such as PayPal, Venmo, Zelle or Cash App.

The rule, which was originally slated to take effect in 2022 and was delayed for 2023, means that a 1099-K form "could be sent to anyone" using those services who makes over $600 per year, according to the agency.

"We spent many months gathering feedback from third-party groups and others, and it became increasingly clear we need additional time to effectively implement the new reporting requirements," said IRS Commissioner Danny Werfel several weeks ago in delaying the rule again.

Prior to the rule, third-party apps only sent 1099-K forms to people who received $20,000 or more in commercial payments across more than 200 transactions.

The IRS has delayed this new reporting rule for two years in a row to give payment apps more time to prepare for the change. One sticking point: Distinguishing between taxable and nontaxable transactions through third-party apps isn't always easy. For example, money your roommate sends you through Venmo for dinner is not taxable. Money received for graphic design work you tackled is. The IRS paused implementation to avoid confusion and incorrect earnings being reported. -CNET

The IRS will begin with a phased rollout, requiring payment apps to report income by freelancers and business owners with earnings over $5,000 vs. $600 in the hopes that raising the threshold will reduce 'noise' from inaccuracies, while eventually working towards the $600 minimum. 

"Taking this phased-in approach is the right thing to do for the purposes of tax administration, and it prevents unnecessary confusion," said Werfel. "It’s clear that an additional delay for tax year 2023 will avoid problems for taxpayers, tax professionals and others in this area."

As the Epoch Times notes further; A provision in the American Rescue Plan requires users to report transactions through payment apps, including Venmo, Cash App and others, for goods and services meeting or exceeding $600 in a calendar year. Before that provision—and now for this year—the reporting requirement applied only to selling goods and services to taxpayers who received over $20,000 and had over 200 transactions.

“The Form 1099-K could be sent to anyone who’s using payment apps or online marketplaces to accept payments for selling goods or providing services. This includes people with side hustles, small businesses, crafters and other sole proprietors,” the IRS said. “However, it could also include casual sellers who sold personal stuff like clothing, furniture and other household items that they paid more than they sold it for.”

“Reporting requirements do not apply to personal transactions such as birthday or holiday gifts, sharing the cost of a car ride or meal, or paying a family member or another for a household bill. These payments are not taxable and should not be reported on Form 1099-K,” the agency added.

There has been confusion about what taxpayers should do if they sell an item at a loss. Those scenarios shouldn’t be taxed but may still generate forms to send to taxpayers.

“Selling items at a loss is not actually taxable income but would have generated many Forms 1099-K for many people with the $600 threshold. This complexity contributed to the IRS decision to delay the additional year to provide the agency time to update its operations to make it easier for taxpayers to report the amounts on their forms,” the agency said.

Starting this month, the IRS will plan a phased rollout of the plan and will require third-party payment apps and services to report business and freelancer earnings of more than $5,000 rather than $600, according to the IRS.

“This means that for 2023 and prior years, payment apps and online marketplaces are only required to send out Forms 1099-K to taxpayers who receive over $20,000 and have over 200 transactions. For tax year 2024, the IRS plans for a threshold of $5,000 to phase in reporting requirements,” said the agency.

https://www.zerohedge.com/personal-finance/irs-venmo-paypal-and-cashapp-freelancers-face-2024-reporting-requirements