Neuronetics and Greenbrook TMS to Merge

 Neuronetics, Inc. (NASDAQ: STIM) (“Neuronetics”) and Greenbrook TMS Inc. (OTCMKTS: GBNHF) (“Greenbrook”) today announced that they have entered into a definitive arrangement agreement (the “Definitive Agreement”) in which Neuronetics will acquire all of the outstanding common shares of Greenbrook in an all-stock transaction.

“This transaction brings together two of the leaders in the mental health space in the U.S., which will allow us to provide access to innovative care to patients suffering from mental health conditions. Leveraging the significant scale and capabilities of the two businesses, we can drive increased awareness of NeuroStar, consistently deliver best practices, facilitate improved reimbursement on a regional and national level, and provide additional services and training opportunities to all of our customers which can improve their business operations,” said Keith Sullivan, President and Chief Executive Officer of Neuronetics. “Beyond the strategic benefits, we believe this acquisition will help create a more attractive financial profile for the combined company, including the increased scale and growth trajectory of our top line, the ability to realize material cost synergies, the acceleration of our path to profitability, and a bolstered balance sheet. In combination, we expect this transaction will create significant long-term value for shareholders.”

“This transaction combines two organizations who share a common mission to better care for the growing number of patients who are suffering from mental health conditions, many of whom are poorly served by medication alone,” said Bill Leonard, President and Chief Executive Officer of Greenbrook. “By combining Neuronetics’ innovative NeuroStar platform as well as their education and training expertise, with Greenbrook’s well established practice operations and support capabilities, we believe the combined company can improve care at Greenbrook’s existing sites and, just as importantly, at any practice across the country that is looking to bring the benefits of NeuroStar to their patients.”

Rationale for the Transaction

By creating a vertically-integrated organization capable of providing access to TMS therapy with significant scale, the acquisition offers multiple strategic benefits for Neuronetics and its customers, including:

• Increased Brand Awareness for NeuroStar TMS. Through marketing efforts under a single brand, Neuronetics expects to be able to drive significant increases in awareness of NeuroStar amongst patients, care givers, and providers.
• More Consistent Delivery of Best Practices. Under centralized management, Neuronetics believes it can better operationalize NeuroStar TMS best practices across all Greenbrook sites nationwide.
• Provides a Variety of Positive Benefits for All NeuroStar Customers. The benefits include increased brand recognition for NeuroStar, the expansion of training opportunities on how to successfully incorporate med management and Spravato® treatment alongside NeuroStar, as well as access to centralized services to improve their business operations, which includes the ability to benefit from regional and national payor contracts, the outsourcing of reimbursement billing and processing, better revenue cycle management, and a national call center.
  

Beyond the strategic benefits, the transaction is expected to create compelling financial benefits, which include:

• Increased Revenue Scale and Strong Growth Trajectory. In fiscal year 2023, the pro forma revenue of the combined company would have been approximately $145 million, effectively doubling the scale of the stand-alone businesses. Additionally, the combined company expects mid-teens year over year revenue growth in fiscal years 2025 and 2026.
• Material Cost Synergies. Through the optimization of marketing spend as well as back office functions, the combined company expects to be able to realize at least $15 million of annualized cost savings, the majority of which will be realized in fiscal year 2025.
• Accelerated Path to Profitability. Coming as a result of strong expected revenue growth and the realization of cost synergies, the combined company anticipates to be Adjusted EBITDA positive and also cash flow positive for the full fiscal year 2025, excluding one-time costs related to the transaction.
• Bolstered Balance Sheet. As a result of the pre-transaction conversion of Greenbrook’s debt into common shares, in combination with the scale of the business post-acquisition, the consolidated company will be able to leverage an improved balance sheet to execute on its long-term growth strategy.

Terms of the Acquisition

Under the terms of the Definitive Agreement:

• Prior to the completion of the transaction, all of Greenbrook’s existing credit facility and subordinated convertible debt will be converted into Greenbrook common shares.
• Greenbrook shareholders will receive a fraction of shares of Neuronetics common stock for each Greenbrook common share owned at the exchange ratio described below such that immediately following the closing of the transaction, Neuronetics shareholders will own approximately 57% of the combined company, and Greenbrook shareholders will own approximately 43% of the combined company, respectively, on a fully diluted basis. As of the date of the Definitive Agreement, each Greenbrook share is expected to be exchanged for 0.01149 shares of Neuronetics common stock at the closing of the transaction, subject to adjustment for any interim period funding by Madryn and other customary adjustments prior to the closing based on the terms of the Definitive Agreement. An aggregate of 25,304,971 Neuronetics shares will be issued to Greenbrook shareholders in connection with the transaction.
• The transaction will be implemented by way of a court-approved plan of arrangement under the Business Corporations Act (Ontario). The transaction must be approved by the Superior Court of Ontario (Commercial List), which will consider the fairness and reasonableness of the transaction to all Greenbrook shareholders.
• As part of the transaction, Madryn Asset Management LP and its affiliates (“Madryn”) has agreed to convert all of the amount outstanding under its credit facility with Greenbrook and all of the subordinated convertible notes of Greenbrook (including notes held by Madryn and other third-parties, which are forced to convert as a result of Madryn’s election) into common shares of Greenbrook prior to the effective date of the transaction. As a result, subject to adjustment for any interim period funding by Madryn and other customary adjustments, Madryn will own 95.3% of the Greenbrook common shares immediately prior to closing and will receive 95.3% of the Neuronetics common stock being issued to Greenbrook shareholders.

• The transaction requires approval by (i) at least 66 2/3% of the votes cast by the holders of Greenbrook shares present in person or represented by proxy at a special meeting of the holders of the Greenbrook shares to be called to consider the transaction; and (ii) a simple majority of the votes cast by the holders of Greenbrook shares present in person or represented by proxy, excluding Greenbrook shares that are required to be excluded under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (including shares held by Madryn).
  
• The issuance of the Neuronetics shares pursuant to the transaction requires approval by holders of a majority of shares of Neuronetics common stock who, being present or voting by proxy and entitled to vote at the Neuronetics stockholder meeting, cast votes affirmatively or negatively on the Neuronetics share issuance resolution. Among other things, Neuronetics will also propose to amend its certificate of incorporation to increase the size of authorized share capital in order to issue the Neuronetics shares. Approval of this proposed amendment will be required by the holders of a majority of the outstanding shares of Neuronetics common stock entitled to vote at the Neuronetics stockholder meeting.
  
• The Definitive Agreement provides for customary deal protection provisions, including reciprocal non-solicitation covenants and rights to match superior proposals.
  
• The Definitive Agreement provides for mutual termination fees of $1,900,000 in the event the transaction is terminated by either party in certain circumstances, including to enter into a superior proposal.
  
• The combined company will continue to operate as Neuronetics, Inc., and trade under the ticker STIM on the NASDAQ stock exchange. Following closing of the transaction, Neuronetics intends to cause the common shares of Greenbrook to be delisted from the OTCQB and to cause Greenbrook to submit an application to cease to be a reporting issuer under applicable Canadian securities laws.
  

Each of Neuronetics’ directors and certain members of the executive leadership team, as of the date hereof, who hold in the aggregate 1,680,718 Neuronetics shares (representing approximately 5.55% of issued and outstanding Neuronetics shares (on a fully-diluted basis) have entered into voting support agreements agreeing to vote their stock in favor of the transaction.

Key shareholders of Greenbrook, including Madryn and certain subordinated convertible noteholders, and directors and certain members of the executive leadership team, as of the date hereof, who hold in the aggregate 16,536,208 Greenbrook common shares (representing approximately 48.7% of issued and outstanding Greenbrook shares (on a non-diluted basis and assuming the cancellation of 11,634,660 outstanding Greenbrook shares on or about August 15, 2024, as previously disclosed by Greenbrook) have entered into voting support agreements agreeing to vote their Greenbrook shares in favor of the transaction.

The Madryn voting agreement is terminable under certain specified circumstances including in the event of receipt of a superior proposal that satisfies a hurdle that represents a 20% premium to the value of the consideration payable under this transaction and, concurrently therewith, the Definitive Agreement is terminated for a superior proposal upon payment of a termination fee. The voting agreement entered into with other key shareholders of Greenbrook are terminable under certain specified circumstances including upon the termination of the Madryn voting agreement.

Greenbrook Strategic Review Process

The transaction is the culmination of a strategic review process undertaken by Greenbrook. The process and negotiation of the transaction was supervised by a committee of independent directors (the “Greenbrook Special Committee”). Both the Greenbrook board and Greenbrook Special Committee determined, after receiving financial and legal advice, that the transaction is in the best interest of Greenbrook and is fair, from a financial point of view, to Greenbrook shareholders (other than Madryn).

Alliance Global Partners has provided an opinion to the Greenbrook board and the Greenbrook Special Committee that, as at the date of its opinion and based upon and subject to the assumptions, limitations and qualifications set out therein, the consideration to be received by the shareholders of Greenbrook pursuant to the transaction is fair, from a financial point of view, to such shareholders.

The terms of the Definitive Agreement were negotiated with oversight and participation of the Greenbrook Special Committee and the assistance of Greenbrook’s external financial and legal advisors. Such terms are reasonable in the judgment of the Greenbrook Special Committee and the Greenbrook board.

Timing and Approvals

The Board of Directors of both companies have unanimously approved the transaction.

The transaction is expected to close during the fourth quarter of 2024, subject to approval by both companies’ shareholders, court approval in respect of the plan of arrangement as well as other customary closing conditions.

https://www.globenewswire.com/news-release/2024/08/12/2928288/0/en/Neuronetics-and-Greenbrook-TMS-Announce-Definitive-Agreement-to-Merge.html

Abeona Meeting with FDA to Align on Upcoming Pz-cel BLA Resubmission

 Significant progress addressing CMC items noted in CRL

BLA resubmission remains on track for 2H 2024

https://www.globenewswire.com/news-release/2024/08/12/2928295/0/en/Abeona-Therapeutics-Reports-Second-Quarter-2024-Financial-Results-and-Concludes-Type-A-Meeting-with-FDA-to-Align-on-Upcoming-Pz-cel-BLA-Resubmission.html

Greelane Intent to be Exclusive US Distributor of Fentanyl, Xylazine, Drink Spike Detector

 High-sensitivity test strips offer powerful detection capability for the current and growing opiate crisis

Combining Greenlane's industry leading omnichannel distribution platform with Safety Strips affordable and highly accurate ISO certified test strips to help prevent opioid-related deaths

https://www.accesswire.com/899230/greenlane-announces-non-binding-letter-of-intent-to-be-the-exclusive-distributor-in-the-us-of-safety-strips-incs-fentanyl-xylazine-and-drink-spike-detection-test-strips

FOIA Files: How Feds, Press, and Academia "Coordinate" On Speech

 by James Rushmore via Racket News,

In March 2023, the University of Washington’s Center for an Informed Public (CIP) put out an article asserting that the Election Integrity Partnership (EIP) — comprised of the CIP, the Stanford Internet Observatory (SIO), Graphika, and the Atlantic Council’s Digital Forensic Research Lab (DFRLab) — was not a “government cut-out” controlled by the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (CISA).

Racket has sent out numerous Freedom of Information (FOIA) requests about the Election Integrity Partnership. Recently, we received several new batches of results from the University of Washington that cast doubt on their earlier assertions. These disclosures, which have been added to the Racket FOIA Library, hint at a dynamic perhaps more intimate than reported. This is the first of a series of disclosures we’ll be publishing this week.

On March 4, 2021, Shira Ovide of The New York Times emailed the EIP to ask what government officials and social media platforms did to “stop disinformation from having a material effect on the [2020] election.”

The response came from Matthew Masterson, at the time a non-resident policy fellow at the Stanford Internet Observatory. Masterson then only just finished working as a senior cybersecurity advisor at CISA, a position he held from March 2018 to December 2020. He stayed at CISA through the 2020 election, then moved to Stanford just in time to receive Ovide’s inquiry as a private citizen. His response is humorous in its frankness (emphasis ours):

Happy to talk regarding the work we (the feds) did in coordination with social media companies to anticipate and respond to efforts to undermine the election.

Masterson’s choice of verb is interesting. For years, “anti-disinformation” activists have insisted that state actors merely contacted social media companies with helpful tips regarding troublesome accounts. Masterson’s response suggests CISA was in close contact with platforms like Twitter throughout the 2020 election cycle, though Ovide wasn’t told how close. (See the accompanying article by Matt Taibbi to learn more.) He’s explicit in his characterization of the EIP-CISA dynamic as a coordinated effort.

When reached for comment, Ovide directed Racket to an article she published shortly after her conversation with Masterson. The former DHS official told Ovide that “coordination was the biggest change that helped shore up digital defenses in [2020] election management systems.” At the time, Masterson said, “This is as good [sic] as the federal government has worked on any issue in my experience.” The piece doesn’t mention the EIP, but it still captures the degree to which federal law enforcement agencies like CISA were in contact with 2020 election officials.

You’ll find more evidence of the tight-knit relationship between CISA and the EIP in their communications the following year. On March 14, 2022, Nicky Vogt, the senior advisor for public affairs at CISA, reached out to the EIP in order to coordinate their messaging efforts on MisinfoDay. (MisinfoDay, for those unfamiliar, is an annual celebration intended to help students, educators, and librarians “learn how to navigate complex information environments and make informed decisions about what to believe online.”)

In an email marked with the subject line “Social Amplification on MisInfo Day?”, Vogt asked Julia Carter Scanlan, the CIP’s director for strategy and operations, if the EIP could “amplify” CISA’s MisinfoDay-themed graphics on its social media accounts. Vogt offered to return the favor by promoting the EIP’s MisinfoDay content on CISA’s accounts. Also worth noting is the “as our team may have mentioned” at the start of Vogt’s email. CISA and the EIP seemed to be on very friendly terms!

Carter Scanlan’s response was enthusiastic (emphasis ours):

I’m so glad we can coordinate on this to help get the word out on both fronts. I’m looping in here my colleague Michael Grass, the CIP’s Assistant Director for Communications. He’s managing all of the social and other media for MisinfoDay and will be point on this.

The word of the day is “coordination.”

A few hours later, Vogt made contact with Grass, who promised to share the EIP’s MisinfoDay content on the CIP’s Twitter, Facebook, and LinkedIn accounts. Grass also indicated that other schools would be participating in the day’s festivities through the #MisinfoDay2022 hashtag.

Here’s the tweet CISA asked Grass to promote.

These emails illustrate the synergies between the “anti-disinformation” industry and the national security state. In theory, the two factions are supposed to be separate entities, but in practice, they represent the same interests. It’s not often that a single disclosure offers evidence of the alacrity with which outfits like the EIP did the bidding of federal law enforcement agencies. We should be grateful for their candor.

Below are a few more excerpts from this latest batch of FOIA disclosures, which you can access in full at the Racket FOIA Library.

• In July 2020, shortly before the EIP officially launched, the key players debated what they wanted to call their partnership. Emerson Brooking of the Atlantic Council recommended against going with the “Election Disinformation Partnership,” arguing that it could “very easily be made to sound like [they] are spreading disinformation,” and suggested the “2020 Partnership.” His suggestion was co-signed by the SIO’s Alex Stamos (“[S]ounds a bit like an Olympics thing.”) and Graphika’s Camille François (“It will fit on a shirt”). The group ultimately settled on the “Election Integrity Partnership,” a name that Stamos described as generic and unlikely to be misinterpreted. (See page 109.)

• On November 17, 2021, Ashley Quarcoo, a senior director at the Partnership for American Democracy, reached out to the EIP to discuss how they could take steps to prepare for “election misinformation” in the 2022 cycle. (See pages 47 and 48.)

• On October 31, 2022, Mark Scott of Politico emailed the SIO’s Renée DiResta with some examples of Telegram channels that were spreading “election-related falsehoods” in swing states during the runup to the midterm elections. Scott asked DiResta if she could account for the spread of such theories “from fringe networks like Telegram to more mainstream networks.” (See page 17.)

Click here to access Racket’s library of University of Washington FOIA productions.

https://www.zerohedge.com/political/foia-files-how-feds-press-and-academia-coordinate-speech

Healthcare-focused SPAC Voyager Acquisition prices $220 million IPO

 Voyager Acquisition, a blank check company targeting the healthcare sector, raised $220 million by offering 22 million units at $10. Each unit consists of one share of common stock and one-half of a warrant, exercisable at $11.50.

The company is led by CEO and Director Adeel Rouf, a former Investment Professional at Cohen and Company Asset Management, and Chairman Warren Hosseinion, who currently serves as President of Nutex Health and previously co-founded Apollo Medical Holdings. It plans to target the healthcare and healthcare-related industries, focusing on businesses with enterprise values between $160 million and $2 billion.

Voyager Acquisition list on the Nasdaq on Friday under the symbol VACHU. Cantor Fitzgerald acted as sole bookrunner on the deal.

Relevant Profile: VACHU

https://www.renaissancecapital.com/IPO-Center/News/106077/Healthcare-focused-SPAC-Voyager-Acquisition-prices-$220-million-IPO

''Boeing's confidence in Starliner 'speaks volumes,' says former NASA astronaut'

 'These commercial companies cannot afford to have an accident because it could completely end their program,' notes former astronaut Eileen Collins

Boeing Co.'s confidence in the ability of its Starliner space capsule to bring NASA astronauts Butch Wilmore and Suni Williams back home to earth "speaks volumes" amid the uncertainty swirling around the troubled mission, according to former Space Shuttle commander Eileen Collins.

There was a major twist in the Starliner saga last week when NASA discussed the possibility of bringing astronauts Wilmore and Williams back to Earth on a SpaceX Crew Dragon spacecraft. But in a statement released after NASA's Aug. 7 press conference, Boeing (BA) said that Starliner could still bring Wilmore and Williams safely home. "Crew Flight Test is currently a crewed mission, and we still believe in Starliner's capability and its flight rationale," the company said. "If NASA decides to change the mission, we will take the actions necessary to configure Starliner for an uncrewed return."

Collins, who is the author of "Through the Glass Ceiling to the Stars: The Story of the First American Woman to Command a Space Mission," feels that Boeing's unequivocal language is noteworthy. "Boeing's statement that they can come home safely on Starliner speaks volumes to me," she said. "These commercial companies cannot afford to have an accident because it could completely end their program."

'Elon's just a call away': Latest twist in Boeing's Starliner saga underlines SpaceX's progress

The former astronaut flew four space shuttle missions during her 16-year NASA career, and was commander of STS-114 in 2005, the 'Return to Flight' mission after the 2003 Columbia disaster. Seven years earlier NASA had been rocked by another tragedy when the space shuttle Challenger exploded 73 seconds after launch.

"The lessons learned from these two accidents are taught to the NASA employees," said Collins. "Because of that, the engineers are willing to speak up, and managers are more willing to listen."

Speaking during last week's press conference, Ken Bowersox, associate administrator of NASA's Space Operations Mission Directorate, said the agency is looking to "drive some more consensus amongst our team," around Starliner. "I have to admit that sometimes, when we get disagreement, it's not fun, it can be painful having those discussions, but it's what makes us a good organization and it's what will get us to a good decision," he added.

NASA and Boeing have wrestled with helium leaks and thruster issues on Starliner, which launched to the orbiting space lab on June 5. The capsule was initially expected to be docked with the ISS for at least eight days before bring Wilmore and Williams home. However, the astronauts have now been on the space station for more than 60 days.

The next SpaceX Crew Dragon flight, Crew-9, will launch to the ISS no earlier than Sept. 24., and is expected to return to Earth in February 2025. Returning Wilmore and Williams on a Dragon spacecraft would mean that only two astronauts, rather than four, launch to the ISS in September. It would also mean that Starliner would undock from the space station and return to Earth uncrewed.

During last week's press conference, NASA said that no decision has yet been made on whether Wilmore and Williams will return to Earth on Starliner or SpaceX's Crew Dragon. A final decision on the astronauts' return journey is expected by mid-August.

Despite the spacecraft's problems, Collins thinks that Starliner will eventually deliver benefits to NASA. "Starliner is having some growing pains, but I think it will be successful in the long run," she told MarketWatch.

The astronaut also told MarketWatch that she knows both Wilmore and Williams personally. "They are highly competent test pilots - they are steady, solid decision makers - they are good test pilots," she said. "If I was Butch and Suni I would insist on daily updates from NASA, as well as Boeing." 

https://www.morningstar.com/news/marketwatch/20240812127/boeings-confidence-in-starliner-speaks-volumes-says-former-nasa-astronaut

Enhancing natural killer cells to target pediatric brain cancer

 Florida State University researchers are giving oncologists another tool in their fight against pediatric brain cancer.

In work published in Bioactive Materials, a research team led by Department of Chemistry and Biochemistry Professor Qing-Xiang "Amy" Sang showed the possibility of enhancing natural killer immune cells to improve their ability to attack a rare pediatric brain cancer.

"Natural killer cells are the policemen of the body," Sang said. "They patrol the body and recognize viruses, bacteria and other pathogens, as well as cancer cells. Our goal is to enhance both the quantity and quality of these cells, making them more potent in their ability to combat cancer."

Natural killer cells can target all types of cancer, and previous research has examined their effectiveness as a therapy. But this is the first study to test the ability of natural killer cells to destroy a specific variety of cancer known as a malignant rhabdoid tumor.

When this tumor appears in the central nervous system, it is called an atypical teratoid rhabdoid tumor (ATRT). Although it is a rare disease, it accounts for 20% of all central nervous system tumors in children younger than 3.

"It's a major unmet clinical need," Sang said. "We still don't have a standard, optimized therapy for children with cancer, especially children with brain cancer."

Natural killer cells are a critical part of the human immune system, but they can be overwhelmed by cancer cells. Sang's research team wanted to see if they could help the fight against this disease and develop a treatment with fewer side effects than traditional approaches such as chemotherapy or radiation therapy.

The researchers derived natural killer cells from human-induced pluripotent stem cells—cells from skin or blood that have been reprogrammed back into an embryonic-like state, allowing them to develop into any type of human cell. Unlike feeder cells from mice, which are typically used in similar studies, human-induced pluripotent stem cell-derived natural killer cells don't pose a risk of rejection by a patient's immune system.

They also enhanced the immune quality of those cells by using different proteins to stimulate them to have a stronger killing power.

Although more work is needed to develop a ready-to-use therapy for cancer patients, the research shows that natural killer cells derived from human-induced pluripotent stem cells could be the basis for future medicines to treat pediatric brain tumors.

"These findings pave the way for developing a safer and more effective immunotherapy for children with brain cancer," Sang said.

Co-authors on this work were graduate researchers Sonia Kiran, Yu Xue and Drishty Badhon Sarker in the Department of Chemistry and Biochemistry in the College of Arts and Sciences, and Yan Li, a professor in the Department of Chemical and Biomedical Engineering in the FAMU-FSU College of Engineering.

More information: Sonia Kiran et al, Feeder-free differentiation of human iPSCs into natural killer cells with cytotoxic potential against malignant brain rhabdoid tumor cells, Bioactive Materials (2024). DOI: 10.1016/j.bioactmat.2024.02.031

https://medicalxpress.com/news/2024-08-natural-killer-cells-pediatric-brain.html