Category: Healthcare

Transatlantic HCLS M&A: The Talent Integration Mandate

Posted on by slightbourne@noblecapitalmarkets.com

Bridging the Compensation, Culture, and Compliance Gaps for Value Realization in 2025

The Healthcare and Life Sciences (HCLS) sector continues to be a powerhouse for global Mergers & Acquisitions (M&A) activity, driven by digitalization, specialized therapeutics, and the imperative for integrated care models. When European entities acquire US counterparts, the primary risk to deal value shifts from financial modeling to human capital integration. In 2025, transatlantic HCLS deals face an unprecedented trifecta of challenges: navigating the US’s competitive, burnout-driven talent market; identifying and realizing true operational synergies; and bridging the fundamental divide between US and EU compensation and benefits philosophies. Successfully integrating talent across these vastly different labor ecosystems is now the defining feature of deal success.

The Fierce Pursuit of Specialized US HCLS Talent

The US HCLS talent market in 2025 is defined by scarcity, rising costs, and high turnover – especially for highly specialized roles in advanced therapeutics, bioinformatics, and AI-driven diagnostics. Would-be European acquirers of US HCLS companies must move beyond reactive hiring to adopt future-ready strategies:

  • Skills-First & AI Operationalization: The industry is moving toward skills-based hiring, particularly for critical roles that drive transformation and innovation (e.g., Gene Editing, GenAI). While AI is being widely operationalized to streamline administrative burdens (scheduling, screening, drafting job descriptions), it has yet to be proven as a strategic tool for high-level talent strategy or predicting cultural fit. Smart integration plans, therefore, should prioritize leveraging AI to accelerate efficiency while reserving human expertise for assessment and strategic sourcing.
  • EVP and Retention over Recruitment: High turnover, burnout, and the rise of non-traditional healthcare employers (tech, consulting) have made retention the top priority. The Employer Value Proposition (EVP) must be hyper-personalized and focused on fostering Equity, Inclusion, and Belonging (EIB), shifting the focus from simply who is hired to who stays, grows, and thrives. Post-merger, US employees often prioritize clear career pathways, flexibility, and supportive management when choosing to remain with the combined entity.
  • Proactive Pipelining: Due to the shrinking talent pool, organizations might rely heavily on talent pipelining and targeted outbound campaigns, establishing relationships with specialized talent before roles are officially posted. Integration teams could leverage the European target’s existing academic partnerships or regional centers of excellence to feed into the US-side pipeline for highly technical roles.

Operational Synergies: A Shift to Scope and Capability

Transatlantic HCLS M&A is increasingly dominated by scope deals—acquisitions focused on new technology, market access, or specific clinical capabilities, rather than simple scale. Synergy capture in these deals is more complex and requires aggressive planning that goes beyond traditional cost-cutting:

  • Revenue Synergies in R&D and Market Access: The most significant value tends to be found in revenue synergies, such as combining the European acquirer’s innovative R&D capabilities and global footprint with the US target’s vast commercialization strength and specialized talent access. Due diligence must build complex synergy models to validate these revenue forecasts, which are inherently more difficult to predict than cost savings.
  • Consolidating Back-Office Functions: Classic operational synergies still apply, particularly in consolidating redundant non-patient-facing functions. Examples include streamlining financial administration, IT infrastructure, and back-office services like Revenue Cycle Management (RCM) or billing. This consolidation can lead to immediate cost savings and process standardization but must be executed early in the integration lifecycle to realize value.
  • Cultural Alignment as a Synergist: Synergy capture is often derailed by poor cultural alignment. Integration planning should prioritize blending cultural elements early on. For a European company acquiring a US firm, navigating different approaches to hierarchy, risk tolerance, and work-life balance will be crucial to retaining the very R&D or specialized operational talent the deal was meant to secure.

Navigating the Transatlantic Compensation & Benefits Chasm

The starkest challenge in harmonizing US and EU operations lies in aligning compensation, benefits, and labor practices, which reflect fundamentally different societal models:

  • The Salary and Contribution Divide: US salaries are generally higher, often dramatically so for specialized roles (e.g., mid-level tech salaries can show a 30–50% gap). However, the underlying employer cost structure differs significantly. US employers bear steep costs for private, market-driven healthcare ($8,000 to $16,000+ per employee annually), while EU employers bear heavy social charges and payroll contributions that fund state-backed universal healthcare and pensions. Integration teams should employ dual benchmarks, modeling both equal salaries (for equity assessment) and market-specific total compensation (for budget control).
  • Mandated Benefits and Labor Law: Europe offers generous, often legally mandated benefits, including a minimum of 20+ paid vacation days, comprehensive parental leave, and stricter labor protections regarding notice periods and dismissal costs. In contrast, US benefits are a competitive tool, varying widely by state and company size. Attempting to impose a US-centric “low vacation, high private insurance” model on EU operations could result in catastrophic talent loss and non-compliance with local labor law.
  • Compliance Complexity: The US operates under a fragmented legal structure of both federal (e.g., ACA and COBRA and state-specific laws (sick leave, minimum wage, worker classification), whereas the EU operates under centralized directives, but implementation varies across 27 Member States (e.g., Spain and Portugal requiring 14-month salaries). HR teams must deploy local expertise to avoid compliance pitfalls, particularly around worker classification and termination processes.

In conclusion, successful transatlantic HCLS M&A requires HR integration teams to treat human capital as a strategic asset, not just a line item. Value is realized when the best of both labor ecosystems is preserved, harmonizing compensation and benefits while leveraging the combined entity’s specialized talent pools through proactive, skills-focused strategies.

In the next installment of our Europe-US Cross-Border HCLS M&A series, we move from people to data, tackling the ultimate transatlantic compliance hurdle: the clash between GDPR and HIPAA. Learn how European acquirers can avoid major fines and deal breaks by meticulously auditing and integrating data governance across two radically different legal frameworks.

About the Authors:

Nathan Cali is a Managing Partner at Noble Capital Markets with more than 18 years of Capital Markets experience. He has been a lead Managing Director/Head of the Healthcare and Life Sciences Investment Banking and Advisory franchise at NOBLE since 2017 and was previously a sell-side equity analyst for 9 years. Nathan is a Board Member of Precise Bio, a tissue engineering, biomaterials, and cell technologies company, including cardiology, orthopedics, and dermatology. He was previously a board observer of Eledon Pharmaceuticals (ELDN:NASDAQ, f.k.n.a. Anelixis Therapeutics, Inc.), a phase II biotechnology company. Prior to joining NOBLE, Nathan gained investment experience as a portfolio account analyst/manager at Franklin Templeton Investments. Nathan also currently holds series 7, 79, 86, and 87 FINRA designations.

Hinesh Patel, MCMI ChMC is a Partner in CNM LLP’s Los Angeles Office with over 20 years of experience in accounting. He leads and oversees the firm’s Accounting and Transaction Advisory practice. He brings a vast knowledge of US GAAP, technical accounting, and International Financial Reporting Standards (IFRS) reporting requirements to his role at CNM. Hinesh primarily focuses on technical accounting, IPO readiness, SEC reporting, and mergers and acquisitions. Prior to joining CNM, Hinesh worked as a Senior Manager at Deloitte with a primary focus in the technology, manufacturing, consumer business and entertainment industries for both public and private companies. He has assisted various companies through the IPO process and advised on a range of accounting services including technical accounting, financial reporting, and new business processes requirements.

Matthew (Matt) Podowitz is the founder and Principal Consultant of Pathfinder Advisors LLC, bringing experience on 400+ global M&A engagements to his clients. He specializes in the critical operational and technology aspects of M&A transactions, providing due diligence, carve-out, integration, and value creation services. Known for practical, actionable advice derived from extensive hands-on experience with healthcare and life sciences transactions, Matt helps companies, investment banks, and private equity firms navigate complex cross-border HCLS M&A through every step of the transaction lifecycle. Leveraging his perspective as a dual US/EU citizen, he provides seamless support for transactions in both markets. His background includes leadership roles at firms like Ernst & Young, Grant Thornton, and CFGI.

Chris Raphaely is the Co-Chair of Cozen O’Connor’s Health Care & Life Sciences Practice where he provides sophisticated transactional and regulatory counsel to an array of health care providers and investors in the health care industry. His practice focuses on mergers, acquisitions, and divestiture transactions for health care clients and the comprehensive regulatory schemes requisite to doing business in the health care space. Chris routinely handles matters involving payer negotiations, payment disputes and contract enforcement, accountable care organizations, management services organization, clinically integrated networks, value based payment arrangements, pharmacy benefit management and third party administrator contracts for self-insured employers, digital health, organizational and governance structures, HIPAA, information privacy and security, tax exemption, Stark Law, fraud and abuse matters, clinical integration, medical staff relations, facility and professional licensing, Pennsylvania’s Medical Marijuana Act, and general compliance. Prior to joining the firm, Chris served as the deputy general counsel to Jefferson Health System and general counsel to the system’s accountable care organization and captive professional liability insurance companies.

Eli Lilly Becomes the First $1 Trillion Drugmaker as Weight-Loss Boom Reshapes Big Pharma

Posted on by slightbourne@noblecapitalmarkets.com

Eli Lilly has officially crossed the $1 trillion valuation mark, becoming the first pharmaceutical company in history to join a market-cap club previously dominated almost entirely by technology giants. The milestone reflects a dramatic reshaping of the healthcare landscape, driven by surging global demand for next-generation weight-loss and metabolic health treatments.

Lilly’s rise has been nothing short of extraordinary. The company’s stock has rallied more than 35% this year alone, fueled largely by explosive growth in the obesity-drug category. Over the past two years, new and highly effective treatments have transformed weight-loss medicine into one of the most profitable segments in all of healthcare. What was once a niche market is now a multibillion-dollar engine attracting unprecedented consumer, medical, and investor interest.

At the center of Lilly’s success are two blockbuster drugs: tirzepatide, marketed as Mounjaro for type 2 diabetes and Zepbound for obesity. Together, they have rapidly climbed to the top of global pharmaceutical sales charts, surpassing even Merck’s cancer drug Keytruda — long considered untouchable as the world’s best-selling medication.

Although rival Novo Nordisk pioneered the modern obesity-drug movement with Wegovy, Lilly seized momentum after early supply shortages hampered Wegovy’s rollout. Stronger clinical results, faster manufacturing scale-up, and broader distribution helped Lilly pull ahead in prescriptions and capture the spotlight as the dominant player in the sector.

The company’s latest quarterly results underscore that shift. Lilly generated more than $10 billion in revenue from its obesity and diabetes medicines—over half of its total $17.6 billion in quarterly sales. Investors now value the company at nearly 50 times its expected earnings, signaling confidence that demand for metabolic-health treatments will remain powerful for years.

The broader market seems convinced as well. Since Zepbound’s launch in late 2023, Lilly shares have surged more than 75%, outpacing the S&P 500’s impressive run. Wall Street analysts estimate the global weight-loss drug market could reach $150 billion by 2030, with Lilly and Novo Nordisk expected to control the vast majority of those sales.

Looking ahead, investors are closely watching Lilly’s upcoming oral obesity drug, orforglipron, which could receive approval as early as next year. Analysts expect it to extend the company’s dominance by offering a pill-based alternative to injectable GLP-1 medications—an option that could unlock even wider adoption.

Beyond drug development, Lilly’s growth is poised to benefit from planned U.S. manufacturing expansions and a federal pricing agreement that is expected to increase patient access. Although the deal may reduce short-term revenue per dose, analysts believe the expanded eligibility—potentially adding tens of millions of U.S. patients—will dramatically enlarge the long-term market.

With its market cap now rivaling major tech players, Lilly is increasingly being viewed as a “Magnificent Seven-style” stock again—an alternative for investors seeking high-growth prospects outside AI and digital infrastructure. Still, challenges remain, including pricing pressure and the need to sustain manufacturing capacity at unprecedented scale.

For now, Lilly’s ascent to the $1 trillion tier signals a new era in which metabolic-health innovation, not just technology, can redefine global market leadership.

Release – Tonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA™ (cyclobenzaprine HCl sublingual tablets) as a First-in-Class Fibromyalgia Treatment

Posted on by slightbourne@noblecapitalmarkets.com

November 17, 2025 7:00am EST

CHATHAM, N.J., Nov. 17, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced today that TONMYATM (cyclobenzaprine HCl sublingual tablets) is now commercially available at pharmacies by prescription in the United States. TONMYA is a first-in-class treatment for fibromyalgia in adults as a non-opioid analgesic taken once daily at bedtime.

“The availability of TONMYA is a momentous day for Tonix, providing the estimated 10 million people living with fibromyalgia a novel treatment that has been shown to address the debilitating, core symptom of this disease, widespread pain,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “After more than 15 years without innovation for this disease, we are honored to bring this new treatment option to patients in partnership with the full fibromyalgia community including researchers, patients, and investigators. We are excited and motivated to make TONMYA accessible to as many patients as possible.”

The latest Phase 3 trial, RESILIENT, was published in Pain Medicine with data on primary endpoints measuring pain, and secondary endpoints measuring patient’s global impression of change, patient-reported symptoms and function, sleep disturbance, and fatigue.

“For years, fibromyalgia patients have struggled with limited treatment options that often fall short. The availability of TONMYA marks a meaningful advancement by targeting neurotransmitters thought to be involved in fibromyalgia,” said Andrea L. Chadwick, M.D., MSc, FASA, Anesthesiology, Pain, and Perioperative Medicine at The University of Kansas Health System.

“We’re truly excited about this new option for people living with fibromyalgia,” said Sharon Waldrop, a person with lived experience and founder of the Fibromyalgia Association. “The availability of TONMYA provides new hope for our community and represents a crucial step forward in fibromyalgia treatment.”

TONMYA was approved by the FDA on August 15, 2025.

The approval incorporated efficacy from two double-blind, randomized, placebo-controlled, Phase 3 clinical trials of nearly 1,000 patients in total that evaluated TONMYA as a bedtime treatment for fibromyalgia. Across both Phase 3 trials, TONMYA significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint. Additionally, a greater percentage of study participants taking TONMYA experienced a clinically meaningful (≥30%) improvement in their pain after three months, compared to placebo.

Across three Phase 3 clinical trials with over 1,400 patients evaluated, TONMYA was generally well tolerated. The most common adverse events (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) included oral hypoesthesia (numbness in the mouth), oral discomfort, abnormal product taste, somnolence (drowsiness), oral paresthesia (tingling, pricking or burning in the mouth), oral pain, fatigue, dry mouth, and aphthous ulcer (canker sore).

For more information, visit TonmyaHCP.com

About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 10 million adults in the U.S., approximately 80% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep (waking up tired and unrefreshed), fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Patients with fibromyalgia have double the medical costs compared to the general population in the U.S.

About TONMYATM (cyclobenzaprine HCl sublingual tablets)
TONMYA, which was investigated as TNX-102 SL, is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride, which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a tertiary amine tricyclic (TAT) and multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TONMYA is now commercially available as a once-daily bedtime treatment for fibromyalgia in adults. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10357465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034. Pending patent applications related to method of use could extend exclusivity until 2044.

About the Phase 3 Clinical Trials: RELIEF and RESILIENT
The RELIEF and RESILIENT studies were double-blind, randomized, placebo-controlled trials designed to evaluate the efficacy and safety of TONMYATM (cyclobenzaprine hydrochloride sublingual tablets) for the treatment of fibromyalgia. RELIEF and RESILIENT were two-arm trials that enrolled 503 and 457 adults with fibromyalgia across 40 and 33 United States sites, respectively. In both trials, the first two weeks of treatment consisted of a run-in period in which participants started on TONMYA 2.8 mg (1 tablet) or placebo. Thereafter, all participants increased their dose to TONMYA 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint across both trials was the daily diary pain intensity score change (TONMYA 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores). Additional details on RELIEF (NCT04172831) and RESILIENT (NCT05273749) are available on clinicaltrials.gov.

RALLY was a replicate Phase 3 trial to RELIEF and RESILIENT that demonstrated greater but non-significant treatment effect with TONMYA compared to placebo and demonstrated consistent safety. Results of this trial may not have been generalizable due to the presence of factors outside the conduct of the study. Additional details are available on clinicaltrials.gov (NCT04508621).

Tonix Pharmaceuticals Holding Corp.
Tonix is a fully integrated, commercial-stage biotechnology company. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, infectious and rare diseases. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. Tonix Medicines, Inc., a wholly owned commercial subsidiary, markets treatments for fibromyalgia and acute migraine.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts
Mary Ann Ondish
Tonix Pharmaceuticals
(862) 799-8599
investor.relations@tonixpharma.com

Brian Korb
astr partners
(917) 653-5122
brian.korb@astrpartners.com

Media Contact
Meagen Hagans
Weber Shandwick
(757)358-2033
MHagans@webershandwick.com

Merck to Acquire Cidara Therapeutics in $9.2 Billion Deal, Strengthening Its Antiviral Pipeline

Posted on by slightbourne@noblecapitalmarkets.com

Merck has announced a major expansion of its infectious disease portfolio with a definitive agreement to acquire Cidara Therapeutics, Inc. for approximately $9.2 billion. The all-cash transaction, valued at $221.50 per share, brings Cidara’s late-stage antiviral candidate CD388 directly into Merck’s pipeline as the company seeks to diversify its portfolio with innovative, long-acting preventative treatments.

The acquisition represents a strategic move for Merck, aligning with its long-standing approach of targeting high-impact scientific assets backed by strong development data. CD388, Cidara’s lead candidate, is considered one of the most promising antiviral innovations currently in development. Designed as a long-acting, strain-agnostic agent, CD388 aims to prevent infection from both influenza A and B, a significant advantage over seasonal vaccines that must be reformulated each year to match circulating strains.

CD388 combines a small-molecule neuraminidase inhibitor with Cidara’s proprietary drug-Fc conjugate (DFC) platform. This design is intended to provide durable protection against symptomatic influenza, particularly in groups most vulnerable to severe complications, such as older adults, cancer patients, and individuals with compromised immune systems.

The therapy is currently in the Phase 3 ANCHOR trial, following strong Phase 2b data in the NAVIGATE study, which demonstrated its effectiveness in preventing symptomatic, laboratory-confirmed influenza among unvaccinated adults. The U.S. Food and Drug Administration has recognized its potential through both Fast Track and Breakthrough Therapy designations, signaling the agency’s acknowledgment of the urgent need for more effective flu-prevention options.

For Merck, adding CD388 to its pipeline complements its existing respiratory portfolio and fills a critical unmet need at a time when influenza continues to cause significant global health burdens. Seasonal influenza leads to millions of infections each year and disproportionately affects high-risk populations. As viral strains evolve and vaccine hesitancy persists, demand for alternative prevention strategies continues to grow.

Cidara leadership characterized the acquisition as a transformative milestone. The company has dedicated its efforts to advancing DFC therapeutics and redefining how influenza can be prevented beyond traditional vaccines. With Merck’s global scale, regulatory strength, and commercial infrastructure, CD388 is positioned to reach markets internationally once approved.

The transaction has been unanimously approved by the boards of both companies. It will be executed through a tender offer by a Merck subsidiary, followed by a merger to acquire all outstanding Cidara shares. Completion of the deal remains subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act. Merck expects the acquisition to close in the first quarter of 2026, accounting for it as an asset acquisition on its financial statements.

With this deal, Merck reinforces its commitment to science-driven expansion and long-term growth, while Cidara gains the resources necessary to bring its innovative antiviral approach to patients worldwide. If successful, CD388 could become one of the most significant advancements in influenza prevention in more than a decade.

Release – The Oncology Institute Reports Third Quarter 2025 Financial Results and Increases Full Year 2025 Guidance

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TOI

Nov 13, 2025

PDF Version

CERRITOS, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) — The Oncology Institute, Inc. (NASDAQ: TOI) (“TOI” or the “Company”), one of the largest value-based community oncology groups in the United States, today reported financial results for its three months ended September 30, 2025 and updated its full year 2025 guidance.

Recent Operational Highlights

  • Fee-for-service revenue growth of 13% over Q3 2024, driven by continued organic growth performance in Florida and Oregon.
  • Retail Pharmacy and Dispensary set fill records, contributing $75.9 million in revenue and $12.8 million in gross profit in Q3. 
  • Signed several new in-network MSO providers in the Florida market and opened our new TOI pharmacy location in Florida.
  • Welcomed Kristin England as our new Chief Administrative Officer overseeing our Enterprise Central Business Operations, Technology Strategy and AI Enablement.

Third Quarter 2025 Financial Highlights

All comparisons are to the quarter ended September 30, 2024 unless otherwise noted

  • Consolidated revenue of $136.6 million increased 36.7% from $99.9 million
  • Gross profit of $18.9 million, increased 31.7%
  • Net loss of $16.5 million compared to net loss of $16.1 million
  • Basic and diluted (loss) earnings per share of $(0.14) compared to $(0.18)
  • Adjusted EBITDA of $(3.5) million compared to $(8.2) million
  • Cash and cash equivalents of $27.7 million as of September 30, 2025

Outlook for Fiscal Year 2025

TOI uses Adjusted EBITDA and Free Cash flow, each a non-GAAP metric, as an additional tool to assess its operational and financial performance. See “Financial Information: Non-GAAP Financial Measures” below. In reliance on the unreasonable efforts exception provided under Regulation S-K, TOI is not reasonably able to provide a quantitative reconciliation for forward-looking information of Adjusted EBITDA and Free Cash Flow to net (loss) income and net cash provided by operations, respectively, the most directly comparable GAAP financial measures, without unreasonable efforts due to uncertainties regarding taxes, capital expenditures, operating activities, share-based compensation, goodwill impairment charges, change in fair value of liabilities, unrealized (gains) losses on investments, practice acquisition-related costs, consulting and legal fees, transaction costs and other non-cash items. The variability of these items could have an unpredictable, and potentially significant, impact on TOI’s future GAAP financial results. The Company, given the revenue and profitability growth in the first three quarters, is updating its full year revenue and Adjusted EBITDA guidance as follows:

 2025 Guidance – Previous2025 Guidance – Updated
Revenue$460 to $480 million$495 to $505 million
Gross Profit$73 to $82 million$73 to $82 million
Adjusted EBITDA$(8) to $(17) million$(11) to $(13) million
Free Cash Flow$(12) to $(21) million$(12) to $(21) million


Additionally, the Company expects Adjusted EBITDA of approximately $0 to $2 million in the fourth quarter of 2025. TOI’s achievement of the anticipated results is subject to risks and uncertainties, including those disclosed in its filings with the U.S. Securities and Exchange Commission. The outlook does not take into account the impact of any unanticipated developments in the business or changes in the operating environment, nor does it take into account the impact of TOI’s acquisitions, dispositions or financings. TOI’s outlook assumes a largely stable global market, which would likely be negatively impacted if recent tariff rate increases and exchange rate changes persist and adversely affect world trade.

Management Commentary

Daniel Virnich, CEO of TOI, commented, “We had a solid third quarter across all lines of our business. Our Pharmacy business continues to set records, and our new delegated lives in Florida are ramping nicely with strong MLR performance. During the quarter, we made meaningful progress in leveraging AI to drive efficiencies in our operations and improve the patient experience. These were just some of the factors that allowed us to increase our full-year guidance and reaffirm our positive outlook for Q4 adjusted EBITDA. As a leader in oncology value-based care, it is important for us to not only raise the quality of care but also lower that cost of care. We believe we are well-positioned to achieve this goal, while simultaneously driving durable and sustainable growth.”

Webcast and Conference Call

TOI will host a conference call on Thursday, November 13, 2025 at 5:00 p.m. (Eastern Time) to discuss third quarter results and management’s outlook for future financial and operational performance.

The conference call can be accessed live over the phone by dialing 1-877-407-0789, or for international callers, 1-201-689-8562. A replay will be available two hours after the call and can be accessed by dialing 1-844-512-2921, or for international callers, 1-412-317-6671. The passcode for the live call and the replay is 13756737. The replay will be available until Thursday, November 20, 2025.

Interested investors and other parties may also listen to a simultaneous webcast of the conference call by logging onto the Investor Relations section of TOI’s website at https://investors.theoncologyinstitute.com.

About The Oncology Institute, Inc.

Founded in 2007, The Oncology Institute, Inc. (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better. For more information visit www.theoncologyinstitute.com.

Forward-Looking Statements

This press release includes certain statements that are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “preliminary,” “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “project,” “predict,” “potential,” “guidance,” “approximately,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding projections, anticipated financial results, estimates and forecasts of revenue and other financial and performance metrics and projections of market opportunity and expectations. These statements are based on various assumptions and on the current expectations of TOI and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by anyone as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of TOI. These forward-looking statements are subject to a number of risks and uncertainties, including the accuracy of the assumptions underlying the 2025 full fiscal year outlook and the Q4 2025 outlook with respect to Adjusted EBITDA discussed herein, the outcome of judicial and administrative proceedings to which TOI may become a party or investigations to which TOI may become or is subject that could interrupt or limit TOI’s operations, result in adverse judgments, settlements or fines and create negative publicity; changes in TOI’s patient or payors’ preferences, prospects and the competitive conditions prevailing in the healthcare sector; failure to continue to meet stock exchange listing standards; the impact of a cybersecurity incident affecting a software provider on TOI’s business; those factors discussed in the documents of TOI filed, or to be filed, with the SEC, including the Item 1A. “Risk Factors” section of TOI’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 26, 2025 and any subsequent Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. If the risks materialize or assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that TOI currently is evaluating or does not presently know or that TOI currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect TOI’s plans or forecasts of future events and views as of the date of this press release. TOI anticipates that subsequent events and developments will cause TOI’s assessments to change. TOI does not undertake any obligation to update any of these forward-looking statements. These forward-looking statements should not be relied upon as representing TOI’s assessments as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

View full release here.

Contacts

Media

The Oncology Institute, Inc.
Daniel Virnich, MD
danielvirnich@theoncologyinstitute.com
(562) 735-3226 x 81125

Investors

ICR Strategic Communications
investors@icrinc.com

Release – Ascertain and The Oncology Institute Co-Develop ‘Touchless’ AI Automation for Oncology Administration

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TOI

Nov 13, 2025

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Partnership deployed touchless prior authorization system in eight weeks, achieving 95% reduction in authorization workload

CERRITOS, Calif. and NEW YORK, Nov. 13, 2025 (GLOBE NEWSWIRE) — Ascertain, a healthcare technology company pioneering agentic AI to automate administrative workflows, and The Oncology Institute, Inc. (NASDAQ: TOI), a leading value-based oncology care provider, today announced a co-development partnership to create “near-touchless” administrative workflows that reduce manual interactions between providers and payers.

The collaboration centers on Ascertain’s Unified Payer Portal (UPP) — an AI-powered automation module that streamlines payer-related tasks required ahead of outpatient oncology visits. The system enables near-touchless workflows by automating manual data entry, documentation submission, and payer portal navigation, significantly reducing the administrative effort required to prepare for each patient encounter.

The joint team achieved rapid implementation, going from a signed statement of work to a live early-stage deployment in just eight weeks. That pace demonstrates both the adaptability of Ascertain’s technology and the strength of the operational partnership between the two organizations.

Since going live in September 2025, the automation has reduced TOI’s office visit authorization submission time at pilot sites by over 80 percent, freeing hundreds of staff hours each week. As TOI scales this solution across all authorization types, the initiative is expected to generate significant efficiencies that could yield up to an estimated $2 million in operating expense savings in 2026. The system now processes prior authorizations across TOI’s 100+ clinics and affiliate locations, allowing staff to focus more time on direct patient care.

Mark Michalski, MD, CEO of Ascertain, said:

“The Oncology Institute has been a national leader in bringing value-based cancer care to scale, and we are proud to co-develop automation tools that help sustain that mission. This first deployment of our Unified Payer Portal represents just the beginning. Together, we’re proving that administrative work between providers and payers can become truly touchless — faster, more accurate, and far less burdensome for clinical teams.”

Daniel Virnich, CEO of The Oncology Institute, said:

“Our partnership with Ascertain reflects TOI’s ongoing focus on operational excellence and efficiency. We’ve seen how thoughtfully applied automation can simplify complex tasks and allow our staff to focus more of their time on supporting patients. This first implementation went live in only eight weeks, and we look forward to continuing to build on that progress with Ascertain’s team.”

About Ascertain

Ascertain is a healthcare technology company using agentic AI to automate complex, forms-heavy administrative workflows in healthcare. The company’s platform replaces manual tasks — such as payer communications, documentation assembly, and eligibility verification — with touchless, intelligent automation. Ascertain was founded in partnership with Northwell Health and Aegis Ventures and is backed by Deerfield Management. For more information, visit www.ascertain.com.

About The Oncology Institute

Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better. For more information, visit www.theoncologyinstitute.com.

Media Contact:
Marisol Sanders
Ascertain
201-228-0693
media@ascertain.com

The Oncology Institute, Inc. (TOI) – Guidance Raised After 3Q25 Revenues Beat Expectations

Posted on by slightbourne@noblecapitalmarkets.com


Friday, November 14, 2025

TOI is an oncology practice management company that provides administrative services to oncology clinics. These clinics provide cancer care to a population of approximately 1.9 million patients. Services include cancer care, pharmacy and dispensary services, clinical trials, and services associated with oncology care. The company employs nearly 120 clinicians and over 700 teammates at over 70 clinic locations.

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.

3Q25 Was A Strong Quarter. The Oncology Institute reported a loss of $16.5 million or $(0.14) per share, with revenues from Patient Services and Dispensary both ahead of our estimates. Adjusted EBITDA turned positive for the first time at the end of the quarter. Management raised guidance for Full-Year Revenues, and confirmed the ranges for Adjusted EBITDA, and Free Cash Flow. On September 30, the company had $27.7 million in cash.

Total Revenues Beat Our Estimates. Total Revenue of $136.6 million easily beat our estimate of $122.5 million. This was an increase from $119.8 million in 2Q25 (up 14%) and $99.9 million (up 37%) in 4Q24. Adjusted EBITDA of $(3.5) million was also better than the $(3.8) million we had estimated. COGS included a new reserve of $8.1 million for bad debts, lowering gross margin from 19.8% to 13.9% compared with the 15.2% we estimated.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

GoHealth (GOCO) – Reset in Progress as Carriers Recalibrate

Posted on by slightbourne@noblecapitalmarkets.com


Friday, November 14, 2025

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

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

Q3 results below expectations. GoHealth reported Q3 revenue of $34.2 million versus our estimate of $100.0 million and an adj. EBITDA loss of $47.1 million, compared with our projected loss of $11.6 million. The variance reflected an intentional pullback in Medicare Advantage policy volume as management prioritized persistency and unit economics over near-term growth.

Health plans facing headwinds. Carriers are contending with lower reimbursement under the new CMS V28 risk model and heightened difficulty maintaining high STAR ratings. These dynamics have shifted industry priorities toward member retention, stability, and margin integrity rather than volume growth, reducing pre-funded marketing and broker commissions across the sector.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Day One Biopharmaceuticals to Acquire Mersana Therapeutics in $285 Million Deal

Posted on by slightbourne@noblecapitalmarkets.com

Day One Biopharmaceuticals announced a definitive agreement to acquire Mersana Therapeutics (Nasdaq: MRSN), marking a strategic move to strengthen its position in oncology drug development. The deal, valued at up to $285 million, combines Day One’s commercial expertise with Mersana’s innovative antibody-drug conjugate (ADC) technology, expanding the company’s pipeline in targeted cancer therapies.

Under the terms of the agreement, Day One will acquire Mersana through a tender offer followed by a merger, offering $25 per share in cash upfront and up to $30.25 per share in additional contingent value rights (CVRs). The CVRs are tied to the achievement of specific clinical, regulatory, and commercial milestones, particularly related to Emi-Le (emiltatug ledadotin), Mersana’s B7-H4-directed ADC candidate. The total equity value at closing is estimated at $129 million, with the full deal potentially reaching $285 million if all milestones are met.

The acquisition highlights Day One’s intent to broaden its oncology focus beyond its current lead programs. Known for its commitment to developing therapies for pediatric and underserved cancer populations, Day One plans to leverage Mersana’s ADC platforms—Dolasynthen and Immunosynthen—to accelerate the development of next-generation cancer treatments.

For Mersana, the deal represents both validation and a strategic exit amid a challenging biotech funding environment. The company has been recognized for its innovative ADC technology, which delivers cytotoxic and immune-modulating agents directly to cancer cells, minimizing harm to healthy tissue. Its lead candidate, Emi-Le, is currently being explored for the treatment of triple-negative breast cancer and adenoid cystic carcinoma, both areas with high unmet clinical needs.

Upon completion of the acquisition, Mersana will become a wholly owned subsidiary of Day One, and its common stock will be delisted from public exchanges. The transaction is expected to close by the end of January 2026, subject to customary regulatory approvals and the tender of a majority of Mersana’s outstanding shares.

The merger agreement was unanimously approved by Mersana’s board of directors, which has recommended that shareholders tender their shares once the offer is formally launched. Key shareholders, including affiliates of Bain Capital Life Sciences, representing approximately 8.5% of outstanding shares, have already agreed to support the transaction.

Financially, TD Cowen is serving as Mersana’s advisor, while WilmerHale is acting as legal counsel. Fenwick & West LLP is representing Day One in the deal.

This acquisition aligns with broader industry trends in oncology, where partnerships and mergers are accelerating innovation in targeted therapies. ADCs have become one of the most promising drug classes in oncology, combining precision targeting with potent efficacy. The addition of Mersana’s technology could give Day One a competitive edge in developing more effective, tumor-specific treatments.

With closing anticipated early next year, the merger positions Day One Biopharmaceuticals as a growing force in precision oncology, combining innovative science with a mission-driven focus on expanding treatment options for patients of all ages battling cancer.

The Beachbody Company (BODI) – Table Is Set For A Promising 2026; Raising Price Target

Posted on by slightbourne@noblecapitalmarkets.com


Wednesday, November 12, 2025

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Solid Q3 Results. The company reported Q3 revenue of $59.9 million and adj. EBITDA of $9.5 million, both of which surpassed our estimates of $54.0 million and $2.6 million, respectively. Additionally, the strong results surpassed the high end of company issued guidance, of $51.0 million to $58.0 million in revenue and $2.0 million to $6.0 million in adj. EBITDA. Furthermore, the company hit an important milestone, recording net income for the first time since 2021.

Improved operating structure. Over the past several years, the company has significantly lowered its break-even point from $900 million in 2022 to $180 million in 2025, largely through SG&A optimization and the elimination of Multi Layer sales costs. The new model offers enhanced operating leverage, enabling profitability at lower revenue levels and providing a favorable outlook ahead of several new product releases.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Cadrenal Therapeutics (CVKD) – 3Q25 Reported With Product Pipeline Updates

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, November 11, 2025

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.

Cadrenal Made A Significant Acquisition In 3Q25. Cadrenal reported a loss of $2.7 million or $(1.31) per share, less than the loss of $3.1 million we estimated. The company also provided an update on clinical progress for tecarfarin and the products acquired through the recent acquisition of eXithera Therapeutics. At the end of the quarter on September 30, the company had cash on hand of $3.9 million.

Tecarfarin Is Making Clinical Progress. During the quarter, the company continued to support the Phase 2 trial in LVAD (left ventricular assist devices) as part of its collaboration with Abbott. Separately, it also continued its consultations with Clinical Investigators to design a Phase 2 trial in dialysis patients previously treated with warfarin. The manufacture of tecarfarin supplies for clinical trials that comply with the FDA’s Good Manufacturing Practices (cGMP) was also completed.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Gyre Therapeutics, Inc (GYRE) – Gyre Reports 3Q25 With Several Clinical Trial Updates

Posted on by slightbourne@noblecapitalmarkets.com


Monday, November 10, 2025

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.

Quarter Sales Were Driven By Etuary. Gyre reported Net Income of $5.9 million or $0.04 per basic share. Revenue of $30.6 million showed year-over-year growth of 20.0%. This was driven by strength in Etuary with sales of $27.7 million. Sales of Etorel and Contiva sales were of $1.5 million and $1.2 million respectively. At the end of 3Q25 on September 30, the company had $80.3 in cash, equivalents, and securities.

The Company Made Progress In Several Important Clinical Programs. During 3Q, Gyre continued working to submit its NDA for Hydronidone approval in China. The Phase 3 trial testing Etuary in pneumonoconiosis completed enrollment, while a Phase 2/3 trial for pulmonary complications in oncology (radiation induced lung injury/pneumonitis) is planned to begin in 4Q25. The IND for a Phase 2 trial in MASH in the US is now expected to be filed in early 2026, within the timeframe we had expected.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Eledon Pharmaceuticals (ELDN) – BESTOW Trial Leads To Misunderstanding of Tegoprubart Data

Posted on by slightbourne@noblecapitalmarkets.com


Monday, November 10, 2025

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.

Phase 2 BESTOW Trial Data Reported. On Thursday evening, November 6, the results of the Phase 2 BESTOW trial in kidney transplant patients were presented. The trial did not meet its primary endpoint of tegoprubart superiority to the control arm but showed improvements in several important endpoints. We believe tegoprubart performed well and that the sharp decline in stock price is unwarranted.

Design Of The Phase 2 BESTOW Trial. The trial enrolled 126 patients into and randomized them into two arms. The first received tegoprubart and the second received tacrolimus, the standard of care, as a control arm. The primary endpoint was a difference in eGFR, a measure of kidney filtration and function. Additional endpoints reported were for the iBOX composite and measures of adverse events.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.