Category: Healthcare

Cara Therapeutics and Tvardi Therapeutics to Merge, Forming New Biopharma Leader

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Cara Therapeutics and Tvardi Therapeutics announce an all-stock merger, set to create a Nasdaq-listed biopharmaceutical company.
– Tvardi’s recent $28 million financing strengthens the combined company’s financial outlook, funding operations into 2026.
– The new entity will focus on developing STAT3 inhibitors for fibrosis-driven diseases, with Phase 2 data expected in 2025.

Cara Therapeutics (Nasdaq: CARA) and Tvardi Therapeutics have announced a definitive merger agreement, marking a significant step in the development of innovative treatments for fibrosis-driven diseases. The all-stock transaction will combine Cara’s resources with Tvardi’s promising pipeline, including its lead candidate, TTI-101, a small-molecule STAT3 inhibitor. The combined entity will be Nasdaq-listed under the name Tvardi Therapeutics, Inc. and is expected to trade under the ticker symbol “TVRD” once the deal closes in the first half of 2025, subject to regulatory and shareholder approvals.

The merger will give pre-merger Cara stockholders an estimated 17% stake in the new company, while Tvardi investors will own around 83%, assuming Cara’s cash balance at closing falls within the expected range. This transaction comes after Tvardi completed a $28 million private financing round, which, alongside the combined company’s cash, will provide funding into 2026, supporting clinical development through critical data readouts expected in 2025.

Tvardi’s pipeline, which is focused on fibrosis-driven diseases, will be the cornerstone of the merged company’s future. The lead candidate, TTI-101, is currently in Phase 2 trials for idiopathic pulmonary fibrosis (IPF) and Phase 1b/2 trials for hepatocellular carcinoma (HCC). The drug is designed to inhibit STAT3, a central transcription factor involved in the progression of these diseases. Early-stage data from the clinical trials is expected to be reported in the second half of 2025, potentially marking significant inflection points for the company.

In addition to TTI-101, Tvardi is developing TTI-109, another STAT3 inhibitor that is set to enter clinical trials in 2025. Tvardi’s innovative approach to targeting STAT3 positions the combined company as a key player in addressing serious, chronic diseases with significant unmet medical need.

The new company will be headquartered in Houston, Texas, and led by Tvardi CEO Imran Alibhai, Ph.D. The board will consist of members from both Cara and Tvardi, with six directors from Tvardi and one from Cara. This leadership structure is expected to ensure a seamless transition as the combined company moves forward with its mission to develop novel, oral therapies for fibrosis-driven diseases.

This merger comes at a time when the biopharmaceutical sector is increasingly focused on addressing complex diseases with limited treatment options. With a strong financial foundation, a promising pipeline, and a leadership team well-versed in the challenges of drug development, the combined company is poised to make significant strides in the field.

As the merger progresses, investors and industry watchers will be closely monitoring upcoming clinical trial results and further developments in the company’s pipeline, which could position Tvardi Therapeutics as a leader in the treatment of fibrosis-driven diseases.

Quanterix Advances Scientific Innovation with Strategic Acquisition of EMISSION

Posted on by slightbourne@noblecapitalmarkets.com
Key Points
– Quanterix acquires EMISSION for $10M, expanding its technological capabilities and entering the OEM market.
– EMISSION’s bead technology enhances Quanterix’s Simoa platform for high-multiplex and multi-omic assays.
– The acquisition is expected to drive revenue growth and improve margins by 2026.

Quanterix Corporation (NASDAQ: QTRX), a company advancing scientific discovery through ultrasensitive biomarker detection, has announced the acquisition of EMISSION iNC., a Georgetown, TX-based manufacturer of proprietary magnetic beads and mid-plex assay platforms. The transaction, expected to close in January 2025, aims to vertically integrate EMISSION’s bead technology into Quanterix’s next-generation platform and drive a new multi-plex segment targeting OEM customers.

Masoud Toloue, Quanterix’s CEO, emphasized the importance of controlling core components to expand their technology stack and capabilities. “EMISSION’s proprietary bead technology has already been validated on our upcoming new Simoa platform and will enable us to provide OEM beads to other non-Quanterix platforms. We look forward to welcoming EMISSION’s innovations and colleagues to the Quanterix team,” he stated.

EMISSION’s magnetic beads are designed for low and mid-plex assays, offering high uniformity and scalability. Their integration into Quanterix’s platform will enhance multi-plex and multi-omic capabilities, ensuring greater control over critical components. EMISSION CEO Van Chandler expressed enthusiasm about the partnership, noting that their high-quality bead technology aligns with Quanterix’s vision to make advanced multi-plex assays accessible to all labs.

The acquisition involves an upfront cash payment of $10 million, with an additional $10 million contingent on the completion of technical milestones. EMISSION may also earn up to $50 million in performance-based payouts, expected to be funded through cash generated from meeting those milestones. Quanterix anticipates the deal will positively impact revenue and gross margins by 2026.

This strategic move reinforces Quanterix’s commitment to innovation in biomarker detection and diagnostics. By integrating EMISSION’s technology, the company strengthens its position in the multi-plex assay market while opening new revenue streams through OEM partnerships. With Simoa technology already setting industry standards for ultrasensitive biomarker detection, the acquisition marks a significant step toward broadening the reach of Quanterix’s tools and solutions.

Quanterix’s focus on neurology, oncology, immunology, and infectious disease research continues to fuel breakthroughs in disease understanding and management. With nearly two decades of experience, the company remains a trusted partner for researchers, boasting over 2,900 peer-reviewed publications featuring its technology. The integration of EMISSION’s beads is expected to enhance Quanterix’s ability to deliver precise, flexible solutions to researchers and clinicians worldwide, further cementing its leadership in the field.

Furthermore, the acquisition aligns with Quanterix’s strategy of vertical integration, which is increasingly critical in the competitive field of diagnostics. By bringing key components in-house, Quanterix not only enhances its technological control but also reduces dependence on external suppliers, paving the way for faster innovation cycles and cost efficiencies. This approach is expected to drive long-term growth and maintain the company’s edge in a rapidly evolving industry.

The addition of EMISSION’s proprietary bead technology also has implications for the broader scientific community. By targeting third-party OEM customers, Quanterix is fostering collaboration and expanding access to advanced diagnostic tools. This could accelerate the adoption of multi-plex assays across various laboratories and research institutions, driving progress in disease diagnostics and personalized medicine.

As the demand for high-sensitivity biomarker detection continues to grow, Quanterix’s ability to deliver scalable, high-quality solutions becomes increasingly vital. The integration of EMISSION’s technology not only reinforces Quanterix’s position as a market leader but also underscores its commitment to empowering scientists with cutting-edge tools to address complex healthcare challenges. With this acquisition, Quanterix is poised to play a pivotal role in shaping the future of diagnostics and research.

Novo Holdings Finalizes $16.5 Billion Acquisition of Catalent

Posted on by slightbourne@noblecapitalmarkets.com

Novo Holdings, the controlling shareholder of Novo Nordisk, has officially completed its $16.5 billion acquisition of Catalent, a leading contract drug manufacturer. This strategic move is poised to bolster Novo Nordisk’s production capabilities for Wegovy, the company’s blockbuster weight-loss medication.

As part of the deal, Novo Nordisk gains control of three key fill-finish facilities located in Italy, Belgium, and the United States. These facilities will now be fully dedicated to manufacturing and filling injection pens for Wegovy, addressing the rising global demand for the medication.

The acquisition process, which began with Novo Holdings’ agreement in February, faced scrutiny from U.S. consumer groups and labor unions urging the Federal Trade Commission (FTC) to block the transaction. Despite these challenges, the FTC did not oppose the deal. Additionally, earlier this month, European antitrust regulators gave their approval, citing sufficient competition in the contract manufacturing market to prevent monopolistic practices.

Wegovy, chemically known as semaglutide, has seen a meteoric rise since its U.S. launch in 2021. It has since expanded to 15 additional countries, becoming a cornerstone of Novo Nordisk’s portfolio. Wegovy belongs to the GLP-1 receptor agonist class of drugs, which mimic a hormone that regulates blood sugar, slows digestion, and suppresses appetite.

The popularity of GLP-1-based drugs, including Eli Lilly’s rival treatment Zepbound, has driven companies to ramp up production to meet skyrocketing demand. Analysts project that the global obesity drug market could reach a staggering $150 billion annually within the next decade.

Novo Nordisk’s acquisition of Catalent is expected to alleviate supply constraints for Wegovy and position the company as a leader in meeting growing patient needs. By integrating Catalent’s state-of-the-art facilities into its operations, Novo Nordisk will enhance its ability to scale production efficiently while maintaining high-quality standards.

The acquisition underscores Novo Holdings’ commitment to advancing innovation in the pharmaceutical industry and supporting Novo Nordisk’s mission to address the global obesity epidemic. With regulatory hurdles cleared and the deal finalized, Novo Holdings and Novo Nordisk are set to play an even larger role in shaping the future of obesity treatment and beyond.

Top Risks Facing Life Sciences Organizations : Insights from Aon’s Global Risk Management Survey

Posted on by slightbourne@noblecapitalmarkets.com

The life sciences sector is currently navigating a complex landscape of evolving and interconnected risks. According to Aon’s recent Global Risk Management Survey, the most pressing concerns for life sciences organizations include supply chain disruptions, cyber attacks, and regulatory changes. These risks are exacerbated by the industry’s heavy reliance on external partners and the need to continuously adapt to new scientific developments and patient needs.

Current Risks

The survey highlighted that supply chain or distribution failure is the top risk facing the industry today. Recent global events have disrupted trade and exposed vulnerabilities in supply chains. The life sciences industry depends heavily on a network of external partners, making it essential for organizations to adopt robust supply chain risk management practices. This includes regular reviews of critical suppliers and comprehensive business continuity planning.

Cyber attacks and data breaches are also a significant concern, ranking as the second-highest risk. The increasing use of digital technologies such as data analytics, the Internet of Things (IoT), and artificial intelligence (AI) in the industry has amplified these risks. Organizations are likely to lose billions globally to cyber attacks in the coming years, underscoring the need for a comprehensive cyber resilience strategy that includes assessment, mitigation, risk transfer, and recovery.

Business interruption, which was the top concern during the height of the COVID-19 pandemic, remains a critical risk but has now fallen to the third position. This shift reflects the ongoing challenges related to supply chain disruptions and the need for organizations to enhance their resilience against such interruptions.

Regulatory or legislative changes are another top concern, ranking fourth among current risks. Changes in government policies, such as those aimed at reducing drug prices or enhancing innovation, can significantly impact the business models of life sciences companies. For instance, recent legislative efforts in the EU and the US are forcing companies to rethink their commercial strategies and prioritize compliance with new regulations.

Failure to attract or retain top talent has emerged as a new critical risk, ranking fifth. The industry is facing a shortage of skilled professionals, particularly in digital fields such as AI and data science. This talent gap is a significant barrier to growth and innovation, highlighting the need for organizations to invest in talent acquisition and retention strategies.

Top 10 Current Risks

  1. Supply Chain or Distribution Failure
  2. Cyber Attack or Data Breach
  3. Business Interruption
  4. Regulatory or Legislative Changes
  5. Failure to Attract or Retain Top Talent
  6. Damage to Brand or Reputation
  7. Product Liability or Recall
  8. Failure to Innovate or Meet Customer Needs
  9. Cash Flow or Liquidity Risk
  10. Capital Availability

Recent global events have pushed these risks to the forefront, making strategic planning and risk management essential components of organizational resilience. Life sciences organizations must continuously monitor and adapt to these evolving risks to maintain their operational and financial stability.

Future Risks

Looking ahead, life sciences organizations anticipate that cyber attacks and data breaches will continue to be a top risk. The increasing digitalization of the industry, coupled with geopolitical volatility, means that cyber threats are likely to remain a persistent challenge. Additionally, the failure to attract or retain top talent is expected to intensify, ranking as the second most significant future risk.

Regulatory or legislative changes are predicted to remain a key issue, rising to the third position in the future. This reflects concerns related to government efforts to manage rising healthcare costs. Supply chain or distribution failure, which is currently the top risk, is expected to drop to the fourth position in the future, potentially due to ongoing efforts to mitigate this risk through improved supply chain resilience practices.

Top 10 Future Risks

  1. Cyber Attack or Data Breach
  2. Failure to Attract or Retain Top Talent
  3. Regulatory or Legislative Changes
  4. Supply Chain or Distribution Failure
  5. Business Interruption
  6. Failure to Implement or Communicate Strategy
  7. Failure to Innovate or Meet Customer Needs
  8. Commodity Price Risk or Scarcity of Materials
  9. Cash Flow or Liquidity Risk
  10. Merger, Acquisition or Restructuring

As the life sciences industry continues to evolve, so too will the risks it faces. Organizations must be proactive in their risk management strategies, ensuring they have the capabilities to assess and mitigate potential losses. This includes adopting comprehensive cyber resilience strategies, improving supply chain risk management, and investing in talent acquisition and retention.

Aon’s survey provides invaluable insights into the current and future risks facing the life sciences sector. For a more detailed exploration of these risks and strategies for mitigating them, read the full article on Aon.com.

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

Posted on by slightbourne@noblecapitalmarkets.com
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.

Poseida Therapeutics to Be Acquired by Roche in $1.5 Billion Deal

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Poseida Therapeutics to be acquired by Roche for up to $1.5 billion, advancing the field of allogeneic CAR-T therapies.
– Poseida’s non-viral, TSCM-rich CAR-T therapies aim to enhance clinical outcomes and expand treatment access.
– Roche’s capabilities in late-stage development and commercialization will bring Poseida’s advancements to patients worldwide.

Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company pioneering allogeneic cell and genetic therapies, announced that it has entered into a definitive agreement to be acquired by Roche Holdings, Inc. in a transaction valued at up to $1.5 billion. Under the agreement, Poseida stockholders will receive $9.00 per share in cash upon closing, along with a contingent value right (CVR) for up to $4.00 per share upon achieving specified milestones. The acquisition has been unanimously approved by Poseida’s Board of Directors, which recommends that stockholders tender their shares.

The merger will bring Poseida’s advanced platform technologies and innovative therapies into Roche’s Pharmaceuticals Division. This acquisition marks a significant expansion of Roche’s capabilities in allogeneic cell therapy, a cutting-edge area of biotech innovation focused on creating “off-the-shelf” treatments. This collaboration builds on an ongoing strategic partnership between Poseida and Roche, particularly in developing CAR-T therapies for hematologic malignancies. The expanded scope will also include CAR-T programs targeting solid tumors and autoimmune diseases.

Poseida’s proprietary technology platform, which utilizes non-viral, T stem cell memory (TSCM)-rich CAR-T therapies, is at the forefront of innovation in cell therapy. TSCM cells are considered highly advantageous due to their long-lived, self-renewing, and multipotent properties, enabling potentially safer and more effective therapies. These characteristics differentiate Poseida’s therapies from other CAR-T approaches, which often rely on more differentiated cells with reduced regenerative capacity.

Highlighting Poseida’s potential, interim clinical data for P-BCMA-ALLO1, a CAR-T candidate for multiple myeloma, have shown compelling results. This reinforces the transformative potential of Poseida’s platform in addressing high unmet needs across various therapeutic areas. Kristin Yarema, Ph.D., President and CEO of Poseida Therapeutics, emphasized the importance of the acquisition:
“Poseida has demonstrated the unique ability of its non-viral platform to deliver TSCM-rich CAR-T therapies with the potential to improve clinical outcomes and expand access. Joining Roche will allow us to accelerate development and bring our therapies to patients worldwide.”

The transaction terms include a tender offer for all outstanding Poseida shares, priced at $9.00 per share in cash at closing. The CVR, valued at up to $4.00 per share, will be contingent upon achieving specific clinical, regulatory, and commercial milestones. Roche plans to acquire any remaining shares not tendered during the initial offer through a second-step merger, ensuring full ownership of Poseida.

The deal is expected to close in the first quarter of 2025, subject to regulatory approvals and customary closing conditions. Centerview Partners LLC and Cooley LLP advised Poseida on the transaction, while Citi and Sidley Austin LLP served as advisors to Roche.

This acquisition represents a major milestone for Poseida and Roche alike. For Roche, it establishes a new core capability in allogeneic cell therapy and genetic medicine, areas that hold immense promise for the future of personalized healthcare. For Poseida, the merger offers an opportunity to leverage Roche’s global resources in late-stage development, commercialization, and market access, enabling its therapies to reach patients worldwide.

As the biotech industry increasingly focuses on transformative therapies, this deal underscores the growing importance of partnerships in accelerating innovation. With Poseida’s cutting-edge technology and Roche’s global expertise, the acquisition is poised to reshape the landscape of cell and genetic therapies, delivering groundbreaking treatments to patients across the globe.

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

Posted on by slightbourne@noblecapitalmarkets.com

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

Posted on by dburczyk@noblecapitalmarkets.com

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

Posted on by slightbourne@noblecapitalmarkets.com
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.

AbbVie Expands Alzheimer’s Pipeline with $1.4B Acquisition of Aliada Therapeutics

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– AbbVie acquires Aliada Therapeutics, adding ALIA-1758 and its unique drug-delivery platform.
– Expands AbbVie’s neuroscience pipeline with advanced Alzheimer’s treatments.
– Aliada’s MODEL platform enhances drug delivery across the blood-brain barrier.

AbbVie has strategically bolstered its Alzheimer’s portfolio by acquiring Boston-based Aliada Therapeutics in a deal valued at $1.4 billion. The acquisition brings AbbVie ALIA-1758, a Phase I anti-amyloid antibody targeting Alzheimer’s disease, along with Aliada’s novel Modular Delivery (MODEL) platform. This technology aims to improve the delivery of therapeutics across the blood-brain barrier (BBB), a significant challenge in developing drugs for the central nervous system.

With Alzheimer’s becoming a critical area for biotech and pharma innovation, AbbVie’s acquisition comes amid heightened interest in anti-amyloid therapies. The recent successes of Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla, the first FDA-approved disease-modifying treatments for Alzheimer’s, have demonstrated the potential of anti-amyloid treatments, though they come with risks. ALIA-1758 is designed to target pyroglutamate amyloid beta, an epitope similar to that in Kisunla, and leverages Aliada’s MODEL platform to improve therapeutic delivery.

The MODEL platform is engineered to transport therapeutic agents across the BBB by targeting transferrin and CD98 receptors, both of which are abundantly expressed in brain endothelial cells. The technology effectively carries antibodies across the BBB, allowing higher therapeutic concentrations in the brain to address amyloid plaques associated with Alzheimer’s. This targeted approach has the potential to provide superior treatment efficacy compared to previous approaches.

This acquisition aligns with AbbVie’s strategy of expanding its presence in neuroscience. The company already has a robust portfolio that includes experimental therapies like ABBV-916, another anti-amyloid antibody; ABBV-552, which targets nerve terminals to enhance synaptic function; and AL002, an antibody developed in partnership with Alector Therapeutics. With the addition of ALIA-1758, AbbVie strengthens its position in the field and continues to invest in innovation that could transform the treatment landscape for neurodegenerative diseases.

While the Alzheimer’s market is promising, AbbVie’s expansion comes with some caution. Analysts have noted that investor sentiment in anti-amyloid drugs is mixed, given the high cost and developmental challenges. However, AbbVie’s investment signals confidence in the MODEL platform’s potential to enhance drug delivery, particularly in addressing diseases with significant unmet needs like Alzheimer’s. AbbVie is optimistic that Aliada’s technology will complement its existing assets and support long-term growth in the neuroscience sector.

Expected to close by the end of 2024, the acquisition of Aliada Therapeutics is subject to regulatory approvals and standard closing conditions. The deal underscores AbbVie’s ongoing commitment to innovation and its mission to bring novel treatments to patients suffering from Alzheimer’s and other neurological disorders.

Three Biotech Companies Price Their IPOs, Raising Significant Capital for Future Growth

Posted on by cpatches
Key Points:
– Upstream Bio raised $255 million to fund advanced trials for its respiratory disease drug verekitug, achieving a valuation of $830 million.
– Ceribell raised $180 million to further develop its AI-powered EEG platform, focusing on diagnosing serious neurological conditions.
– CAMP4 Therapeutics raised $75 million to continue its work in gene expression therapies, pricing its IPO below expectations at $11 per share.

Three biotech companies priced their initial public offerings (IPOs) on Thursday, securing substantial funding to advance their innovative therapies and technologies. The companies—Upstream Bio, Ceribell, and CAMP4 Therapeutics—collectively raised millions, with plans to use the proceeds for various clinical trials and product developments.

Upstream Bio: Raising $255 Million for Respiratory Therapies Upstream Bio led the day by raising $255 million, with its shares priced at the higher end of the expected range. Initially planning to sell 12.5 million shares between $15 and $17 each, the company increased the offering to 15 million shares due to high demand, pricing them near $17. This could further rise if underwriters exercise their option to purchase an additional 2.25 million shares. The company, which now has a valuation of around $830 million, will trade on the NASDAQ under the ticker symbol UPB.

Upstream Bio is using the capital to advance clinical trials for its lead drug, verekitug, which is being tested for severe asthma and chronic rhinosinusitis with nasal polyps. The drug targets a receptor for thymic stromal lymphopoietin, a key player in inflammatory diseases. Proceeds will also help initiate a phase 3 trial for severe asthma.

Ceribell: Secures $180 Million for AI-Powered Neurological Diagnostics Ceribell, a commercial-stage medical technology company, raised $180 million through its IPO, with 10.6 million shares priced at $17 each, giving the company a valuation of $578 million. Like Upstream, Ceribell also granted underwriters the option to purchase additional shares—up to 1.6 million more. The company will trade on the NASDAQ under the symbol CBLL.

Ceribell specializes in AI-powered neurological diagnostic tools, notably its point-of-care electroencephalography (EEG) platform, designed to help in the diagnosis and management of critical neurological conditions. The technology is expected to revolutionize the way healthcare providers address neurological emergencies.

CAMP4 Therapeutics: Raises $75 Million Despite Pricing Below Expectations CAMP4 Therapeutics saw its IPO priced below expectations, at $11 per share, compared to an initial range of $14 to $16. Despite this, the company managed to sell 6.8 million shares, surpassing its original goal of 5 million, for total gross proceeds of $75 million. CAMP4 will begin trading on the NASDAQ under the ticker symbol CAMP.

CAMP4 focuses on regulatory RNA-targeting therapeutics, aiming to upregulate gene expression in genetic diseases. The proceeds will be used to further develop its drug pipeline, including its recent collaboration with BioMarin to target RNA sequences for therapeutic applications.

Release – SelectQuote’s SelectRx Pharmacy to Open a State-of-the-Art Third Fulfillment Center in Olathe, Kansas, to Support Rapid Growth

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SLQT

09/04/2024

OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT) today announced that SelectRx, the company’s full-service medication management pharmacy that serves all 50 states, will open a third fulfillment facility in Olathe, Kansas, to serve its rapidly expanding customer base, alongside its existing facilities in Monaca, Pennsylvania, and Indianapolis, Indiana.

SelectQuote launched the SelectRx business in 2021 as part of its Healthcare Services Division after acquiring two smaller pharmacy operations. In just over three years, SelectRx has grown its membership from under 5,000 to over 75,000 members who receive regular prescription shipments in adherence-friendly packaging. The new 54,000 square foot state-of-the-art facility at 404 W. Frontier Lane in Olathe, Kansas, is expected to open during the first half of calendar 2025 and should significantly expand the pharmacy’s capacity.

SelectQuote plans to add over 50 new positions at the location and is seeking experienced pharmacists, pharmacy fulfillment technicians (to assist in filling, processing, and shipping prescriptions), and various leadership and support roles such as shipping and inventory management, facilities management and information technology.

In 2023, SelectRx was recognized as a Patient-Centered Pharmacy Home (PCPH) by The Compliance Team. PCPH is based on TCT’s CMS-recognized Patient-Centered Medical Home program, which puts special emphasis on health maintenance, preventative screening, medication management, multi-specialty medical services, patient experience reporting, and benchmarking for chronically-ill patients.

SelectQuote CEO Tim Danker commented, “We are thrilled with the rapid growth of our SelectRx business over the past three years. With this new facility, we will be able to extend this highly convenient and adherence-friendly pharmacy solution to many more Seniors who can benefit from it. We are also thrilled to build out this beautiful new facility in our home market of Kansas City.”

About SelectQuote:

Founded in 1985, SelectQuote (NYSE: SLQT) provides solutions that help consumers protect their most valuable assets: their families, health, and property. The company pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads.

With an ecosystem offering high touchpoints for consumers across Insurance, Medicare, Pharmacy, and Value-Based Care, the company now has four core business lines: SelectQuote Senior, SelectQuote Healthcare Services, SelectQuote Life, and SelectQuote Auto and Home. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a specialized medication management pharmacy, and Healthcare Select which proactively connects its members with best-in-class healthcare services that fit each member’s unique healthcare needs. The platform improves health outcomes and lowers healthcare costs through proactive engagement and access to high-value healthcare solutions.

Investor Relations:
Sloan Bohlen
877-678-4083
investorrelations@selectquote.com

Media:
Matt Gunter
913-286-4931
matt.gunter@selectquote.com

Source: SelectQuote, Inc.

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

Posted on by dburczyk@noblecapitalmarkets.com

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.