Healthcare Giants Unite: Transcarent’s $621M Accolade Acquisition Set to Revolutionize Patient Care Navigation

Key Points:
– Deal values Accolade at $7.03 per share, 110% premium over market price
– Combined platform will serve 1,400+ employer and payer clients
– Integration merges AI technology with 16 years of healthcare data expertise

In a landmark move that signals a major shift in digital healthcare delivery, Transcarent announced today its acquisition of healthcare advocacy leader Accolade in a $621 million all-cash deal. The strategic combination promises to transform how millions of Americans navigate and access their healthcare benefits.

The merger brings together Transcarent’s cutting-edge AI-powered WayFinding platform with Accolade’s established expertise in health advocacy and primary care services. This integration aims to address one of healthcare’s most persistent challenges: making quality care more accessible and understandable for consumers while reducing costs for employers and payers.

“Healthcare today is too confusing, too complex, and too costly,” stated Glen Tullman, Transcarent’s CEO. The company’s recent success is evident in its addition of over 500,000 new members in January 2025 alone, demonstrating strong market demand for integrated healthcare solutions.

The combined platform will leverage Accolade’s 16 years of healthcare data and expertise alongside Transcarent’s advanced AI capabilities to create what both companies describe as “One Place for Health and Care.” This unified approach will offer comprehensive services including cancer care, surgery care, weight health programs, and pharmacy benefits, all accessible through a single, intuitive interface.

Accolade CEO Rajeev Singh highlighted the shared vision driving the merger: “The two companies share a focus on embracing AI and advanced technology to change the way consumers experience the healthcare system.” This alignment extends to both companies’ commitment to improving healthcare outcomes while reducing costs.

The transaction, financed through equity funding led by General Catalyst and Glen Tullman’s 62 Ventures, represents a significant premium for Accolade shareholders at $7.03 per share. General Catalyst’s CEO Hemant Taneja will join Transcarent’s Board of Directors, bringing additional strategic oversight to the merged entity.

Looking ahead, the combined company faces the challenge of integrating two distinct technological platforms while maintaining service quality for their existing client base. However, the potential benefits – including reduced healthcare costs, improved access to care, and a more streamlined user experience – could set new standards for digital healthcare delivery.

The deal is expected to close in the second quarter of 2025, subject to regulatory approvals and Accolade stockholder approval. Upon completion, Accolade will transition to private ownership and delist from Nasdaq, marking the end of its public company chapter but the beginning of a potentially transformative era in healthcare technology.

MAIA Biotechnology (MAIA) – MAIA Announces Supply Agreement For Second Phase 2 Trial With Three New Indications


Wednesday, January 08, 2025

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Agreement With BeiGene Covers THIO-102 In 3 Indications. MAIA announced a clinical supply agreement with BeiGene to use its checkpoint inhibitor, Tevimbra (tislelizumab) in combination with THIO in the upcoming Phase 2 THIO-102 trial. The trial will test THIO with tislelizumab in three tumor types. MAIA will avoid the expense of the drug while BeiGene will see clinical data from its PD-1 inhibitor, a recent entry to the market.

The Phase 2 THIO-101 Is On Schedule As THIO-101 Preparations Begin. The Phase 2 THIO-101 trial testing the combination of THIO with Libtayo (cemiplimab, an anti-PD-1 checkpoint inhibitor from Regeneron) in non-small cell lung cancer (NSCLC) is in its final stages. Interim results over the past year have shown meaningful improvements in overall survival (OS) and several other clinical measures of efficacy. Long term patient data is expected in 2H25.


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Amedisys and UnitedHealth Extend Deadline for $3.3 Billion Merger Amid Regulatory Challenges

Key Points:
– Amedisys and UnitedHealth extended the merger deadline to Dec. 31, 2025, or 10 days after a court ruling, amid DOJ and state regulatory challenges.
– The agreement includes a breakup fee ranging from $275 million to $325 million if certain divestitures are not completed by May 1, 2025.
– Amedisys shares rose by over 4% following the extension announcement, reflecting investor optimism.

UnitedHealth Group (UNH) and Amedisys (AMED) have announced an extension of the deadline to finalize their $3.3 billion merger as regulatory hurdles persist. Initially set for completion this week, the merger now faces delays as the U.S. Department of Justice (DOJ) and state regulators challenge its potential market implications.

The DOJ and multiple state regulators have raised concerns over the merger, citing its potential to give UnitedHealth disproportionate control in the home health and hospice care market. This market is a critical component of the healthcare sector, providing essential services to aging populations and those requiring specialized care. Regulators argue that the deal could stifle competition, leading to higher costs and reduced innovation.

The case is currently under review in a Maryland federal court, where a judge will decide whether the merger can proceed. UnitedHealth and Amedisys have committed to addressing these concerns, emphasizing the potential benefits of the merger, including improved service delivery and expanded care options.

In a regulatory filing on Friday, Amedisys disclosed that both companies waived their right to terminate the merger agreement until Dec. 31, 2025, or the 10th business day following the court’s final ruling, whichever comes first. This extension reflects the companies’ confidence in resolving the legal challenges and underscores their commitment to completing the transaction.

To mitigate antitrust concerns, the companies have agreed to a regulatory breakup fee. If the deal falls apart, Amedisys could be entitled to $275 million, increasing to $325 million if the firms fail to divest specific assets by May 1, 2025. These provisions highlight the high stakes of the merger and the potential financial consequences of a failed agreement.

News of the extended deadline brought a positive response from investors, with Amedisys shares rising by over 4% in early trading on Friday. The surge reflects market optimism about the companies’ ability to navigate the legal landscape. Conversely, UnitedHealth shares saw minimal change, reflecting the market’s cautious outlook on the prolonged regulatory process.

The merger, announced in June 2023, represents a strategic move for both companies. Amedisys specializes in home health and hospice care, and its integration into UnitedHealth’s portfolio would significantly enhance the latter’s healthcare offerings. Despite the challenges, both firms remain steadfast in their commitment to completing the transaction and addressing regulatory concerns.

The federal court’s ruling will be pivotal in determining the merger’s future. If approved, the deal could reshape the home healthcare landscape, introducing new efficiencies and expanded services. However, failure to secure approval could force both companies to reevaluate their strategies.

Candel Therapeutics Stock Skyrockets 172% After Promising Phase III Prostate Cancer Trial Results

Key Points:
– Candel Therapeutics’ stock surged 172% after its Phase III trial of CAN-2409 for localized prostate cancer met its primary endpoint.
– The trial showed a 14.5% relative improvement in disease-free survival compared to placebo, with promising long-term results.
– The company plans to use Phase III data to seek regulatory approval from the FDA for CAN-2409.

Candel Therapeutics (CADL) has seen its stock price surge by 172% following the announcement of positive results from its Phase III clinical trial of CAN-2409, a viral immunotherapy designed for localized prostate cancer. This breakthrough was announced on December 11, 2024, signaling the potential of CAN-2409 as a new treatment option for patients battling prostate cancer.

The Phase III trial, conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA), tested CAN-2409 in combination with radiation therapy and the antiviral drug valacyclovir. The trial showed a statistically significant improvement in disease-free survival, with patients experiencing a 14.5% relative increase in survival compared to the placebo group after 54 months of observation. These results demonstrate the treatment’s ability to improve long-term outcomes for prostate cancer patients.

In addition to the survival benefit, the study also found an increased proportion of patients achieving a prostate-specific antigen (PSA) level associated with remission, further supporting CAN-2409’s potential as a promising treatment. The therapy works by stimulating the immune system to attack prostate cancer cells, offering a novel approach compared to traditional treatments, which often rely on chemotherapy or radiation alone. Importantly, the treatment demonstrated no new safety concerns, with a safety profile similar to that of existing therapies.

The company’s CEO, Paul Peter Tak, expressed confidence in the results, emphasizing that the Phase III trial validated earlier observations of CAN-2409’s effectiveness in hard-to-treat tumors. Tak noted that the study’s design, agreed upon by the FDA, could allow Candel to seek regulatory approval for CAN-2409 as a treatment for localized prostate cancer.

Dr. Glen Gejerman, the principal investigator of the study, highlighted the clinical significance of the results, noting that the improvement in disease-free survival could mark a major advancement in prostate cancer care. Gejerman also pointed out that CAN-2409 offers a treatment option without introducing substantial toxicity, which is a key concern for many prostate cancer therapies.

Candel Therapeutics now plans to use the data from this Phase III trial to advance its marketing application to the FDA. If approved, CAN-2409 could provide a much-needed treatment alternative for patients with localized prostate cancer, transforming the current treatment paradigm.

This success positions Candel as a leader in the prostate cancer space, with investors reacting positively to the trial’s results. The company’s stock price has risen significantly, reflecting growing confidence in its future prospects.

Candel’s success comes at a time when other companies in the prostate cancer field, such as Arvinas and Pfizer, are also advancing their own treatments. However, the dramatic stock increase following the Phase III results highlights the excitement surrounding CAN-2409 and its potential to change the landscape of prostate cancer treatment.

As the company moves toward FDA approval, the oncology community will be watching closely. If successful, CAN-2409 could become a game-changing option for prostate cancer patients, offering new hope and a more effective treatment strategy.

How Trump’s DOGE Initiative Could Reshape Biotech’s Future

The Department of Government Efficiency (DOGE), spearheaded by Donald Trump with the involvement of Elon Musk and Vivek Ramaswamy, promises sweeping changes to federal operations, including deregulation efforts targeting agencies like the FDA. For the biotech industry, these potential reforms could significantly impact drug development, approval processes, and market dynamics.

Faster Approvals: A Biotech Catalyst

The FDA’s rigorous drug approval process ensures safety and efficacy but often takes years and billions of dollars to navigate. By streamlining these regulations, DOGE could shorten timelines for bringing therapies to market. This shift would lower barriers for smaller biotech firms, enhance their ability to innovate, and reduce costs for large pharmaceutical companies.

For investors, expedited approvals would translate to quicker revenue streams for new drugs, driving valuations and fueling confidence in the sector. This environment could spur a rally in biotech stocks, particularly for companies with promising pipelines awaiting FDA clearance.

Risks of Deregulation

However, deregulation comes with significant challenges. The FDA exists to ensure public safety, and relaxing oversight could lead to unintended consequences. If subpar drugs enter the market, public trust in the industry might erode, and companies could face litigation or reputational damage. These risks could temper investor enthusiasm, particularly if deregulation is perceived as compromising safety.

Additionally, deregulation might benefit well-established players disproportionately. Large pharmaceutical firms with the resources to navigate even a reduced regulatory framework may thrive, while smaller biotech startups could struggle to compete despite faster approvals.

Investor Implications

DOGE’s initiatives might catalyze investment in biotechnology, particularly in areas like gene therapy, oncology, and rare diseases. Sectors with high unmet needs and long development cycles stand to gain the most from expedited approvals. Furthermore, the promise of reduced R&D costs could attract private equity and venture capital to early-stage biotech firms.

In the stock market, the potential for reform could trigger bullish sentiment in biotech ETFs and sector-specific indices. Companies with late-stage trials or pending FDA decisions might see the greatest benefit. However, volatility is likely as the industry adapts to new regulations, and investors should be cautious of overvaluations driven by speculative enthusiasm.

Industry Innovators at the Forefront

As these potential regulatory shifts emerge, a select group of biotech pioneers are positioning themselves to capitalize on the DOGE initiative’s promising landscape. At the upcoming NobleCon conference, a plethora of healthcare companies will showcase their innovative approaches and strategic vision, offering investors and industry observers a glimpse into how they might leverage potential FDA streamlining and accelerated approval processes. These organizations represent the cutting edge of biotech innovation, each poised to potentially benefit from the proposed regulatory reforms.

Broader Impacts on Healthcare

Beyond the biotech sector, DOGE’s focus on efficiency could reshape the broader healthcare landscape. Cheaper and faster drug approvals might improve patient access to innovative treatments. Yet, balancing speed with safety will be critical to achieving long-term success.

The initiative also highlights the growing intersection of politics and business, with leaders like Musk and Ramaswamy advocating for entrepreneurial approaches to governance. Whether DOGE delivers on its promises remains to be seen, but its potential to disrupt traditional industries, including biotechnology, is undeniable.

DOGE represents both opportunity and risk for biotech investors. If executed thoughtfully, its reforms could unlock unprecedented growth in the sector by fostering innovation and reducing costs. However, ensuring safety and maintaining public trust will be critical to its long-term success. Investors should monitor regulatory developments closely, as the outcomes of these reforms will shape the biotech landscape for years to come.

The biotech rally might already be on the horizon—if DOGE achieves its ambitious goals, this sector could see transformative growth.

Release – Schwazze Announces Preliminary Third Quarter 2024 Financial Results

Research News and Market Data on SHWZ

DENVER, Nov. 07, 2024 (GLOBE NEWSWIRE) — Medicine Man Technologies, Inc., operating as Schwazze, (OTC: SHWZ) (Cboe CA: SHWZ) (“Schwazze” or the “Company”), today announced preliminary financial and operational results for the third quarter ended September 30, 2024.

“We continued to generate momentum from our retail growth and optimization initiatives in Q3, reflected by our ability to outpace two highly competitive markets while generating sequential improvements in profitability and positive cash flow from operations,” said Forrest Hoffmaster, Interim CEO of Schwazze. “Our efforts to sharpen our pricing and promotional strategy, elevate the in-store experience, and improve product quality, assortment and in-stock positions are yielding positive results. I’m proud of our team’s hard work and dedication to drive these improvements in the overall customer experience, which has led to increased store traffic in both Colorado and New Mexico. Over the past year, our focused efforts to optimize our operations have built a solid foundation, setting the stage for sustained growth and enhanced levels of profitability in the year ahead.

“Due to our ongoing re-review process with our new auditor, Baker Tilly, we expect a delay in filing our Form 10-Q for the quarter ended September 30, 2024. Our team, in close collaboration with Baker Tilly, is making every effort to complete this re-review promptly. We expect to release our unaudited third quarter results and host a conference call in the coming weeks to discuss our financial and operational performance in greater detail.”

Q3 2024 Preliminary Financial Results

Based on preliminary and unaudited results, the Company expects to report the following for the third quarter ended September 30, 2024:

  • Revenue of approximately $42 million
  • Adjusted EBITDA of approximately $11 million
  • Cash flow from operations of approximately $0.2 million

At quarter end, the Company held cash and cash equivalents of approximately $11 million with principal amount of debt outstanding of approximately $196 million.

Update on Delayed Filing

As previously announced on April 8, 2024, Schwazze dismissed BF Borgers CPA PC (“BF Borgers”) as its independent registered public accountant and engaged Baker Tilly US, LLP (“Baker Tilly”) as its new independent accountant. Subsequent to the transition, on May 3, 2024, the SEC issued an Order against BF Borgers for systemic failures in meeting PCAOB standards, which impacted over 1,500 SEC filings and affected at least 75 percent of BF Borgers’ 369 clients.

As a result of the SEC Order, Schwazze’s new auditor needs additional time to complete its prior period review, which includes re-auditing the Company’s fiscal year 2023 financial statements and re-reviewing the closing of its 2022 balance sheet prior to filing its 2024 Annual Report. Baker Tilly is actively working to re-audit the Company’s financial statements for the associated periods.

Due to the ongoing re-review process, Schwazze anticipates a delay in filing its Quarterly Report on Form 10-Q for the three- and nine-months ending September 30, 2024. Moreover, the Company expects to simultaneously file its Quarterly Report on Form 10-Q for the three months ending March 31, 2024, and June 30, 2024.

About Schwazze

Schwazze (OTC: SHWZ) (Cboe CA: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to explore taking its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale.

Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth. To learn more about Schwazze, visit https://schwazze.com/.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include financial outlooks; any projections of net sales, earnings, or other financial items; any statements of the strategies, plans and objectives of our management team for future operations; expectations in connection with the Company’s previously announced business plans; any statements regarding future economic conditions or performance; and statements regarding the intent, belief or current expectations of our management team. Such statements may be preceded by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intends,” “plans,” “strategy,” “prospects,” “anticipate,” “believe,” “approximately,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” or the negative of these terms or other words of similar meaning in connection with a discussion of future events or future operating or financial performance, although the absence of these words does not necessarily mean that a statement is not forward-looking. We have based our forward-looking statements on management’s current expectations and assumptions about future events and trends affecting our business and industry. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. Therefore, forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) regulatory limitations on our products and services and the uncertainty in the application of federal, state, and local laws to our business, and any changes in such laws; (ii) our ability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (iii) our ability to identify, consummate, and integrate anticipated acquisitions; (iv) general industry and economic conditions; (v) our ability to access adequate capital upon terms and conditions that are acceptable to us; (vi) our ability to pay interest and principal on outstanding debt when due; (vii) volatility in credit and market conditions; (viii) the loss of one or more key executives or other key employees; and (ix) other risks and uncertainties related to the cannabis market and our business strategy. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

Investor Relations Contact
Sean Mansouri, CFA or Aaron D’Souza
Elevate IR
(720) 330-2829
ir@schwazze.com

Astrana Health to Acquire Prospect Health in $745 Million Deal, Expanding U.S. Healthcare Network

Key Points:
– Astrana will acquire Prospect Health to expand its U.S. provider network across four key states.
– The transaction includes a $1,095 million bridge financing, backed by major financial institutions.
– The acquisition aligns with Astrana’s mission to provide localized, high-quality healthcare, benefiting 1.7 million members.

Astrana Health, Inc. (NASDAQ: ASTH), a technology-driven healthcare provider, has entered a definitive agreement to acquire Prospect Health, a healthcare system with a robust network in California, Texas, Arizona, and Rhode Island. This acquisition is valued at $745 million and aims to expand Astrana’s reach across critical U.S. markets, enabling coordinated, high-quality care for approximately 1.7 million Americans. Expected to close by mid-2025, the transaction will mark a significant expansion for Astrana in the U.S. healthcare sector.

Astrana’s acquisition of Prospect Health includes an array of healthcare assets such as the Prospect Health Plan, medical groups in four states, a pharmacy (RightRx), and Foothill Regional Medical Center in California. Prospect currently serves around 610,000 members across Medicare Advantage, Medicaid, and Commercial plans through its 3,000 primary care providers and 10,000 specialists. The acquisition will allow Astrana to strengthen its position as a leading U.S. healthcare delivery platform, focused on providing accessible, high-value care.

Astrana will fund the purchase with a combination of cash and a $1,095 million senior secured bridge commitment from Truist Bank and J.P. Morgan. The transaction includes an extended closing timeline, aiming for regulatory approvals and completion by mid-2025. The combined network will also bring substantial integration risks, given the complexity of merging operations across multiple states and entities. However, Astrana anticipates that its investment in infrastructure improvements will help ensure local, personalized care in each region.

CEO Brandon K. Sim noted that the acquisition represents a union of two organizations with a shared mission of patient-centric care. Prospect’s established presence in markets like Southern California will allow Astrana to expand beyond its current regions, particularly into Orange County, where Astrana has limited operations. This geographic expansion, coupled with Astrana’s technology-enabled healthcare model, will provide a scalable solution for accessible healthcare in diverse communities.

Astrana expects Prospect to generate approximately $1.2 billion in revenue, with adjusted EBITDA of around $81 million for 2024. This acquisition aligns with Astrana’s strategy to grow through value-based care and increase its reach across new markets while ensuring continuity of care for Prospect’s patients. According to CFO Tom Holloway, Astrana projects the transaction to be immediately accretive to earnings per share, excluding expected synergies, thus enhancing shareholder value over the long term.

Jim Brown, CEO of Prospect, expressed optimism about the partnership, highlighting shared cultural values and operational synergies between the companies. He emphasized that the acquisition will create a larger, more coordinated care network that offers improved access, quality, and efficiency for patients. The integrated healthcare system will enable Astrana to expand its end-to-end technology capabilities and support local healthcare infrastructure with continued investment in infrastructure and patient services.

Avid Bioservices to be Acquired by GHO Capital and Ampersand in $1.1 Billion Deal

Key Points:
– Avid Bioservices will be acquired by GHO Capital and Ampersand Capital in a $1.1 billion deal, with a 13.8% per-share premium.
– Acquisition to enhance Avid’s biologics CDMO services with expanded resources for development and manufacturing.
– Expected to close in Q1 2025, enabling Avid to operate privately and accelerate its service offerings for the biotechnology sector.

Avid Bioservices, Inc. (NASDAQ: CDMO), a major biologics contract development and manufacturing organization (CDMO), announced its acquisition by GHO Capital Partners LLP and Ampersand Capital Partners for approximately $1.1 billion. The all-cash transaction positions Avid for substantial growth, with the backing of experienced healthcare-focused investors to expand its development and manufacturing capabilities in the biotechnology sector. This acquisition marks a strategic move for GHO and Ampersand, leveraging Avid’s expertise to strengthen their portfolios in the life sciences industry.

Under the agreement terms, GHO and Ampersand will acquire Avid’s outstanding shares for $12.50 each in cash, reflecting a 13.8% premium over Avid’s closing share price and a 21.9% premium over its 20-day average. This values the transaction at $1.1 billion, enhancing Avid’s growth potential within a private company framework where it can develop its offerings with the support of dedicated capital and expanded industry networks.

Alan MacKay and Mike Mortimer, Managing Partners of GHO, expressed their excitement to work with Avid’s team to realize the company’s full potential, calling Avid “an ideal addition” that exemplifies their mission to improve healthcare access through efficient manufacturing and high-quality innovation. The deal will enable Avid to maintain its focus on serving the biotechnology and pharmaceutical sectors, helping it meet growing demand for complex biologics at clinical and commercial stages. Additionally, the acquisition aligns with GHO and Ampersand’s broader healthcare strategies, aiming to optimize Avid’s impact in global markets.

Nick Green, President and CEO of Avid, noted that partnering with GHO and Ampersand comes at an opportune time, as Avid has been strategically expanding to meet a broader range of customer needs. He emphasized that this partnership will further Avid’s impact, positioning it to better serve biopharma innovators by utilizing GHO and Ampersand’s resources. “After years of investment and expansion, now is the right time to move forward as a private company,” Green stated, expressing confidence that this move will significantly enhance Avid’s capabilities.

The acquisition is expected to support Avid’s future projects, including cell line development, CGMP clinical and commercial manufacturing, analytical testing, and expanded services for early-stage programs. This additional support allows Avid to optimize customer offerings, broaden its expertise, and develop new industry capabilities that align with its dedication to quality and regulatory standards.

The acquisition, unanimously approved by Avid’s board of directors, is expected to close in Q1 2025, pending customary approvals. Avid’s shares will no longer be publicly traded after the acquisition, and the company will continue to operate under its current name and brand identity, with its headquarters remaining in Tustin, California. Financial and legal advising for Avid are being handled by Moelis & Company LLC and Cooley LLP, respectively, while GHO and Ampersand are advised by William Blair & Company and Ropes & Gray LLP.

This partnership reflects GHO and Ampersand’s strategic investment approach, enabling Avid to strengthen its leadership in biologics manufacturing and develop solutions that respond to high-growth demand in the industry.

Sonnet BioTherapeutics Announces $5 Million Offering and Surge in Trading Volume

Key Points:
– Sonnet BioTherapeutics priced a $5 million public offering to fund research and trials.
– The offering sparked a significant increase in Sonnet’s trading volume.
– Sonnet advances its FHAB platform with promising cancer treatments like SON-1411 and SON-1010.

Sonnet BioTherapeutics (NASDAQ: SONN), a clinical-stage biotech company specializing in oncology-focused immunotherapies, has priced a $5.0 million underwritten public offering. The offering includes 1,111,111 shares of common stock, each sold with one common warrant for the purchase of an additional two shares, at a combined price of $4.50 per share. This offering is set to close on or around November 7, 2024, and is expected to generate gross proceeds of approximately $5.0 million before underwriting discounts and commissions.

The proceeds from this offering are intended to fund Sonnet’s ongoing research and development, clinical trials, working capital, and liability repayments, advancing the company’s mission to develop novel biologic therapies for cancer treatment. While the offering is an exciting opportunity for the company to secure necessary funding, it also brings with it potential risks, including the possibility of shareholder dilution through the issuance of new shares and warrants.

Notably, Sonnet’s share price has seen increased volatility today, with trading volume significantly surging. This rise in trading activity follows the announcement of the offering and its anticipated closure. As is often the case with at-the-market offerings under Nasdaq rules, the pricing of the shares could pressure the stock value in the short term. However, investors may also be reacting positively to the financial backing that will enable Sonnet to accelerate the clinical development of its promising drug pipeline.

Sonnet is known for its proprietary FHAB (Fully Human Albumin Binding) platform, which enables the development of biologic drugs designed to target tumor and lymphatic tissues more efficiently. This technology utilizes a human single-chain antibody fragment (scFv) to hitch a ride on human serum albumin, guiding the drug directly to the target tissue for improved therapeutic effectiveness. The FHAB platform is adaptable, enabling the creation of a wide range of therapeutic candidates, including cytokines, peptides, antibodies, and vaccines.

One of Sonnet’s leading therapeutic candidates is SON-1411, a novel bifunctional fusion protein designed to enhance the efficacy of the immune response against cancer. SON-1411 combines IL-18BPR (a receptor that binds IL-18) with IL-12 and is linked to the FHAB platform. This innovative approach is aimed at overcoming limitations observed in previous IL-18-based therapies, which suffered from poor efficacy due to the presence of IL-18 binding protein (IL-18BP) in the tumor microenvironment. By modifying the IL-18 domain, SON-1411 seeks to bypass this issue and enhance the therapeutic potential of IL-18 in cancer treatment.

In addition to SON-1411, Sonnet is also advancing SON-1010, an IL-12-FHAB fusion protein, through clinical trials for solid tumors and ovarian cancer. The company is evaluating SON-1010 in collaboration with Roche, in combination with the immune checkpoint inhibitor atezolizumab, for the treatment of platinum-resistant ovarian cancer. Moreover, Sonnet is working on SON-1210, a combination of IL-12-FHAB and IL-15, for the treatment of solid tumors like pancreatic cancer.

Despite the potential dilution concerns stemming from the offering, the announcement underscores the company’s strategic commitment to advancing its promising drug candidates. As Sonnet BioTherapeutics progresses through clinical trials and secures additional funding, the surge in trading volume today suggests strong market interest in the company’s future prospects. The funding from the offering will be crucial in supporting Sonnet’s clinical trials and advancing the company’s vision of delivering targeted, effective treatments for cancer patients.

Organon to Acquire Dermavant, Expanding into U.S. Dermatology with VTAMA Cream

Organon, a global healthcare company focused on improving women’s health, announced a major acquisition of Dermavant Sciences Ltd., a subsidiary of Roivant. This acquisition includes Dermavant’s innovative dermatologic therapy, VTAMA® (tapinarof) cream, 1%, which is approved for treating plaque psoriasis and is currently under FDA review for atopic dermatitis.

The acquisition enhances Organon’s presence in the U.S. dermatology market, adding to their international portfolio. This move aligns with Organon’s mission to provide treatments for conditions that disproportionately affect women. The inclusion of VTAMA cream, which addresses psoriasis and potentially atopic dermatitis, fits into their strategic goal of expanding access to effective therapies. Dermavant’s established commercial team will integrate with Organon’s market capabilities, further extending the product’s reach.

Dermavant’s VTAMA cream has been a game changer in the dermatology space. Approved in May 2022, it provides a non-steroidal, once-daily treatment option for plaque psoriasis, a condition that impacts over 8 million Americans. Unlike traditional steroid treatments, VTAMA cream is free of safety warnings, making it an appealing option for long-term use. The product is also under review to extend its use to treat atopic dermatitis, a common inflammatory skin condition affecting over 16.5 million adults and 9.6 million children in the U.S.

Organon’s acquisition of Dermavant not only strengthens its foothold in the U.S. market but also provides a new channel for global growth. Organon CEO Kevin Ali emphasized that this acquisition is part of their commitment to improving women’s health and that integrating Dermavant’s operations would accelerate VTAMA’s availability to patients. With Organon’s commercial scale, they expect to significantly increase patient access to this novel therapy globally.

The acquisition is structured with an upfront payment of $175 million, a milestone payment of $75 million contingent upon FDA approval for atopic dermatitis, and additional payments of up to $950 million tied to commercial milestones. Dermavant shareholders will also receive tiered royalties on net sales. The deal, subject to regulatory approvals, is expected to close by the fourth quarter of 2024.

The acquisition complements Organon’s portfolio of women’s health solutions, biosimilars, and established medicines, bringing a much-needed dermatological therapy into its fold. VTAMA cream has been a success, becoming the top branded topical for plaque psoriasis within just two months of its launch. Organon expects that the therapy will continue to grow, especially as the FDA considers its use for atopic dermatitis.

For Dermavant, the deal provides an opportunity for continued growth, with the support and scale of Organon to take VTAMA to new markets and potentially reach millions of patients globally.

With this acquisition, Organon is well-positioned to further expand its impact in dermatology, providing innovative treatments for plaque psoriasis and potentially atopic dermatitis. The company continues to focus on improving the lives of patients, particularly women, by offering accessible and effective healthcare solutions.

Release – Modern Twist to Centuries-Old Smallpox Vaccine Poised to Combat Deadly Mpox Strain as WHO Declares Global Emergency

Research News and Market Data on TNXP

This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.

CHATHAM, NJ / ACCESSWIRE / August 23, 2024 / Following an upsurge of cases in the Democratic Republic of the Congo and several other countries in Africa, the World Health Organization (WHO) declared mpox a public health emergency of international concern on Aug. 14 – the second such declaration in two years. The WHO has called on vaccine manufacturers to step up efforts to curb the spread of a new, more deadly strain of the virus.

The WHO also is asking companies and organizations to bring in their vaccines, inviting developers of mpox vaccines to submit an Expression of Interest for Emergency Use Listing (EUL).

Amid this backdrop, Tonix Pharmaceuticals (NASDAQ:TNXP) is developing a vaccine candidate, called TNX-801, that could play a role in combating this escalating global health crisis. Tonix has successfully completed non-human primate studies showing protection from challenge with lethal doses of the Clade 1 monkeypox virus that is driving the new epidemic.

Clearly more testing is ahead for TNX-801, but the technology behind it is rooted in the science of Edward Jenner’s smallpox vaccine of the late 1700s, the only vaccine to successfully eradicate a contagious viral pathogen.

These credentials have earned the vaccine technology platform upon which TNX-801 is based a competitive spot in the NIH’s NextGen program for a more effective, single-dose COVID-19 vaccine to potentially provide durable protection instead of the every-six month booster strategy of mRNA vaccines.

Last month, another of Tonix’s technologies was awarded a contract for up to $34 million by the U.S. Department of Defense to develop a single broad spectrum antiviral that would work against multiple potential biowarfare agents.

An Historical Approach to Modern Challenges
The current mpox crisis can be traced back to a decision made in the 1970s to discontinue routine smallpox vaccinations after smallpox was successfully eradicated. Research shows that the smallpox vaccine also provided immunity against mpox. In retrospect, smallpox vaccination kept mpox out of the human population in Africa. So an unintended consequence of stopping vaccinations for smallpox meant that mpox, then known as monkeypox (which is still the name of the virus), was able to reemerge in the human population.

Tonix’s mpox vaccine is believed to be closely related to the original smallpox vaccine invented by British physician Edward Jenner in 1796. Jenner’s vaccine is credited with being the first and only vaccine to successfully eradicate a viral pathogen. This triumph depended on several important attributes of the vaccine, including that it was generally well-tolerated, provided long-term immunity with a single dose, prevented forward transmission and provided a simple biomarker confirmation of protective immunity known as a “take”.

TNX-801 is designed to have these same attributes; it is delivered in a single dose that provides protective immunity to animals that is marked by a “take”. It is believed to have a high likelihood of providing durable immunity and preventing forward transmission. Furthermore, unlike many other vaccines, TNX-801 does not require complex ultra cold-chain storage, making it a strong candidate for global distribution.

The Science Behind TNX-801
Unlike mRNA vaccines, which primarily elicit an antibody response that requires frequent booster shots, TNX-801 is designed to trigger a robust T-cell response. T-cells have the ability to recognize and remember internal parts of viral proteins, not just those on the surface. T-cell memory lasts for years – even decades – providing long-term immunity and potentially eliminating the need for repeated boosters.

In preclinical trials, Tonix says TNX-801 demonstrated the ability to prevent death, clinical disease and lesions caused by a lethal challenge of monkeypox virus in non-human primates. Similar to Jenner’s smallpox vaccine, TNX-801 also significantly reduced viral shedding, suggesting that it can block forward transmission,. Tonix is rushing to manufacture vaccine suitable for Phase 1 human trials.

Beyond Mpox: A Platform for Future Pandemics
The vaccine platform on which TNX-801 is based has potential applications beyond mpox. The company says the TNX-1800 version of the platform, for example, is designed to protect against COVID-19 and has shown promise in preclinical studies. The U.S. National Institute of Health has recognized the potential of Tonix’s platform by selecting it for Project NextGen, aimed at developing next-generation COVID-19 vaccines and pandemic platform technologies.

As the world faces the growing threat of mpox and other infectious diseases, Tonix Pharmaceuticals is not only attempting to address the current crisis with TNX-801, but also potentially contributing to a future where pandemics can be more predictably contained.

Featured photo by Gilnature on iStock.

This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice.

Click here for more information on Tonix Pharmaceuticals: https://redingtonvirtual.com/tnxp-aw-24082/

Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

SOURCE: Tonix Pharmaceuticals Holding Corp.

Release – Cadrenal Therapeutics Announces Upcoming Type-B FDA Meeting in September to Discuss Tecarfarin Trial in LVAD Patients

Research News and Market Data on CVKD

PONTE VEDRA, Fla., Aug. 22, 2024 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage, next-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions, announced today that it will be engaging with the U.S. Food and Drug Administration (FDA) in early September for a Type-B meeting to discuss its clinical trial for tecarfarin in LVAD patients.

“This upcoming meeting with the FDA is a crucial step in developing tecarfarin as we prepare for our pivotal trial. We look forward to discussing the development program for tecarfarin in LVAD patients,” said Quang Pham, Chief Executive Officer of Cadrenal Therapeutics.

ABOUT LVAD PATIENTS

Left Ventricular Assist Devices (LVADs) are mechanical pumps to support heart function in patients with advanced heart failure. These devices are vital for patients awaiting heart transplants or those who are ineligible for transplants. However, LVAD patients face an increased risk of thromboembolic events, such as strokes, which necessitates ongoing anticoagulation therapy. The current anticoagulation therapy, warfarin, presents challenges, including variability in dosing, a narrow therapeutic window, and potential interactions with other medications, making effective management crucial to reducing complications and ensuring patient safety.

ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions. Tecarfarin has orphan drug designation for the prevention of thrombosis and thromboembolism in patients with ventricular assist devices. Tecarfarin also has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation. Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with thrombotic antiphospholipid syndrome (APS). Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in 11 human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.

SAFE HARBOR STATEMENT

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the Company engaging with the FDA in early September for a Type-B meeting to discuss its clinical trial for tecarfarin in LVAD patients and the planned pivotal trial. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to improve anticoagulation treatment in patients, the success of the Type-B meeting, the ability of the Company to commence and complete a pivotal trial and commercialize tecarfarin with patients with left ventricular assist devices (LVADs), and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/cadrenal-therapeutics-announces-upcoming-type-b-fda-meeting-in-september-to-discuss-tecarfarin-trial-in-lvad-patients-302228174.html

SOURCE Cadrenal Therapeutics, Inc.

Release – Published Findings Highlight Tecarfarin’s Potential and Reinforce Need for Better Anticoagulation Therapy in LVAD Patients

Research News and Market Data on CVKD

  • Analysis features the growing need to evolve anticoagulation therapy beyond warfarin to avoid gastrointestinal bleeding, a significant and common complication for left ventricular assist device (LVAD) patients resulting in expensive hospitalizations
  • Tecarfarin, a novel vitamin K antagonist (VKA), uses a different metabolic pathway than warfarin, the most commonly used anticoagulant for LVAD patients, and may offer more stable and effective anticoagulation

PONTE VEDRA, Fla., Aug. 20, 2024 — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage, next-generation VKA oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices or rare cardiovascular conditions, today highlighted a manuscript that was recently peer-reviewed and published in the Journal of Cardiac Failure evaluating the relationship between time in therapeutic range, or TTR, management quality and LVAD patient clinical outcomes. These findings focus on the potential role of investigating new VKA agents beyond warfarin in improving clinical outcomes in LVAD patients.

In the manuscript co-authored by Mandeep R. Mehra, MD, MSc, FRCP, Brigham and Women’s Hospital Heart and Vascular Center, Center for Advanced Heart Disease, titled “Antithrombotic Strategies with Left Ventricular Devices,” the findings conclude that although the current generation of LVAD pumps has largely overcome hemocompatibility-related adverse events there is a continuing need to evolve the anticoagulant therapy to avoid persistent gastrointestinal bleeding, which leads to frequent hospital admissions, procedures, blood transfusions, decreased quality of life and increased cost of care.1

Dr. Mandeep Mehra, who chaired the ARIES-HM3 study, commented, “Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic anticoagulation since it does not get affected by drug-drug interactions or changes in kidney function like warfarin and deserves further study.”

A secondary analysis of the ARIES-HM3 trial, sponsored by Abbott, evaluated the relationship between VKA management quality and clinical outcomes, wherein a median TTR for VKAs of 56% was achieved. This analysis found an inverse relationship between TTR and bleeding events, with a 47% reduction in bleeding risk for patients with a TTR above the median. Lower TTRs were associated with threefold more sub-therapeutic INRs than supra-therapeutic INRs, with no clear correlation between higher INRs and bleeding events.

“These findings provide us with increased confidence that tecarfarin has the potential to address the LVAD patients’ critical unmet anticoagulation needs more effectively,” said Quang X. Pham, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “We are excited to work with the LVAD community to potentially bring our next-generation VKA to patients.”

About Tecarfarin
Tecarfarin is the only oral anticoagulant in development worldwide for patients with implanted cardiac devices and other rare cardiovascular conditions. It has been uniquely designed to overcome many of the challenges patients experience with warfarin. Tecarfarin is metabolized using carboxyl esterase rather than the cytochrome P450 system, which allows the drug to avoid interactions with many other commonly used medications and may offer more stable anticoagulation, including those patients with renal dysfunction, which is common in LVAD patients. In a Phase II study with 66 patients with atrial fibrillation switched from warfarin to tecarfarin, the mean interpolated TTR was 71.4% within three weeks, with minimal time spent in extreme INR ranges (<1.5 and >4.0). If approved, tecarfarin has the potential to be the only on-label drug for LVAD patients in the U.S.

In addition, tecarfarin may prove valuable for other patients where warfarin is not providing recommended anticoagulation because of genetic warfarin resistance or renal impairment making warfarin metabolism difficult. These include individuals with end-stage kidney disease and atrial fibrillation or those with mechanical heart valves and hard-to-control International Normalized Ratio, which measures how long it takes the blood to clot.

On August 6, 2024, Cadrenal Therapeutics announced that it had been in discussions with Abbott about Cadrenal’s planned pivotal study of tecarfarin in patients with recently implanted LVADs. LVAD patients require lifelong anticoagulation to protect against thromboembolic events. The only LVAD available in the U.S. is Abbott’s HeartMate 3TM.

On April 9, 2024, Cadrenal Therapeutics announced that the U.S. Food and Drug Administration (FDA) had granted tecarfarin Orphan Drug Designation for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device, which includes the LVAD.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics Is Developing Tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions. Tecarfarin has an orphan drug designation for the prevention of thrombosis and thromboembolism in patients with ventricular assist devices (VADs). Tecarfarin also has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation. Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with thrombotic antiphospholipid syndrome. Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in 11 human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.

Safe Harbor Statement
Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding tecarfarin offering more stable and effective anticoagulation than warfarin, the potential role of investigating new VKA agents beyond warfarin in improving clinical outcomes in LVAD patients, the continuing need to evolve the anticoagulant therapy to avoid persistent gastrointestinal bleeding and tecarfarin potentially being an important therapy for patients with LVADs who all require chronic anticoagulation since it does not get affected by drug-drug interactions or changes in kidney function like warfarin, tecarfarin having the potential to address the LVAD patients’ critical unmet anticoagulation needs more effectively and potentially bringing the Company’s r next-generation VKA to patients The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to improve anticoagulation treatment in patients, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices (LVADs), and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/published-findings-highlight-tecarfarins-potential-and-reinforce-need-for-better-anticoagulation-therapy-in-lvad-patients-302225967.html

SOURCE Cadrenal Therapeutics, Inc.