Release – SelectQuote, Inc. Reports Second Quarter of Fiscal Year 2026 Results

Research News and Market Data on SLQT

02/05/2026

Second Quarter of Fiscal Year 2026 – Consolidated Earnings Highlights

  • Revenue of $537.1 million
  • Net income of $69.3 million
  • Adjusted EBITDA* of $84.7 million

Fiscal Year 2026 Guidance Ranges:

  • Revenue expected in a range of $1.61 billion to $1.71 billion
  • Adjusted EBITDA* expected in a range of $90 million to $100 million

Second Quarter Fiscal Year 2026 – Segment Highlights

Senior

  • Revenue of $261.5 million
  • Adjusted EBITDA of $102.5 million
  • Approved Medicare Advantage policies of 257,279

Healthcare Services

  • Revenue of $230.7 million
  • Adjusted EBITDA of $0.8 million
  • 113,483 SelectRx members

Life

  • Revenue of $43.6 million
  • Adjusted EBITDA of $5.6 million

OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT) reported consolidated revenue for the second quarter of fiscal year 2026 of $537.1 million compared to consolidated revenue for the second quarter of fiscal year 2025 of $481.1 million. Consolidated net income for the second quarter of fiscal year 2026 was $69.3 million compared to consolidated net income for the second quarter of fiscal year 2025 of $53.2 million. Finally, consolidated Adjusted EBITDA* for the second quarter of fiscal year 2026 was $84.7 million compared to consolidated Adjusted EBITDA* for the second quarter of fiscal year 2025 of $87.5 million.

Tim Danker, SelectQuote Chief Executive Officer, “This year’s AEP again highlighted the strength and consistency of SelectQuote’s operating model. Despite continued volatility in Medicare Advantage benefit structures, our team delivered another season of high‑quality execution, with strong agent productivity and marketing efficiency driving 39% Adjusted EBITDA* margins for our Senior business. At the same time, our rapidly growing Healthcare Services segment, led by SelectRx, continues to provide meaningful clinical value for members and attractive long‑term economics for our platform. The combination of improved medication adherence, lower waste, and better patient outcomes reinforces SelectRx as an increasingly important driver of value creation for the company and broader pharmacy ecosystem.

Our revised fiscal 2026 guidance reflects two discrete, partner‑driven headwinds: a national carrier’s decision to constrain additional MA policy volume by curtailing strategic marketing spend across all channels, and the previously communicated PBM reimbursement changes. Neither impact related to our internal performance, which remained strong. While these developments are frustrating, they do not alter our conviction in the long‑term earnings power of SelectQuote’s comprehensive healthcare platform.

What continues to give us confidence is the consistency of our underlying operational execution. Regardless of the market backdrop, our teams have demonstrated the ability to drive efficiency, deliver value for partners and beneficiaries, and maintain strong margin discipline. Coupled with our improved balance sheet flexibility, we believe this operational consistency positions SelectQuote to deliver meaningful cash‑flow generation for shareholders in the quarters and years ahead.”

* See “Non-GAAP Financial Measures” below.

Segment Results

We currently have three reportable segments: 1) Senior, 2) Healthcare Services and 3) Life. The performance measures of the segments include total revenue and adjusted EBITDA. Costs of commissions and other services revenue, cost of goods sold-pharmacy revenue, marketing and advertising, selling, general, and administrative, and technical development operating expenses that are directly attributable to a segment are reported within the applicable segment. Indirect costs of revenue, marketing and advertising, selling, general, and administrative, and technical development operating expenses are allocated to each segment based on varying metrics such as headcount.

Senior

Financial Results

The following table provides the financial results for the Senior segment for the periods presented:

Operating Metrics

Submitted Policies

Submitted policies are counted when an individual completes an application with our licensed agent and provides authorization to the agent to submit the application to the insurance carrier partner. The applicant may have additional actions to take before the application will be reviewed by the insurance carrier.

The following table shows the number of submitted policies for the periods presented:

Approved Policies

Approved policies represents the number of submitted policies that were approved by our insurance carrier partners for the identified product during the indicated period. Not all approved policies will go in force.

The following table shows the number of approved policies for the periods presented:

Lifetime Value of Commissions per Approved Policy

Lifetime value of commissions per approved policy represents commissions estimated to be collected over the estimated life of an approved policy based on multiple factors, including but not limited to, contracted commission rates, carrier mix and expected policy persistency with applied constraints. The lifetime value of commissions per approved policy is equal to the sum of the commission revenue due upon the initial sale of a policy, and when applicable, an estimate of future renewal commissions.

The following table shows the lifetime value of commissions per approved policy for the periods presented:

Healthcare Services

Financial Results

The following table provides the financial results for the Healthcare Services segment for the periods presented:

Operating Metrics

Members

The total number of SelectRx members represents the amount of active customers to which an order has been shipped and the prescriptions per day represents the total average prescriptions shipped per business day. These two metrics are the primary drivers of revenue for Healthcare Services.

The following table shows the total number of SelectRx members as of the periods presented:

The total number of SelectRx members increased by 17% as of December 31, 2025, compared to December 31, 2024, due to our strategy to grow SelectRx membership.

The following table shows the average prescriptions shipped per day for the periods presented:

Combined Senior and Healthcare Services – Consumer Per Unit Economics

Combined Senior and Healthcare Services consumer per unit economics represents total MA and MS commissions; other product commissions; other revenues, including revenues from Healthcare Services; and operating expenses associated with Senior and Healthcare Services, each shown per number of approved MA and MS policies over a given time period. Management assesses the business on a per-unit basis to help ensure that the revenue opportunity associated with a successful policy sale is attractive relative to the marketing acquisition cost. Because not all acquired leads result in a successful policy sale, all per-policy metrics are based on approved policies, which is the measure that triggers revenue recognition.

The MA and MS commission per MA/MS policy represents the LTV for policies sold in the period. Other commission per MA/MS policy represents the LTV for other products sold in the period, including DVH prescription drug plan, and other products, which management views as additional commission revenue on our agents’ core function of MA/MS policy sales. Pharmacy revenue per MA/MS policy represents revenue from SelectRx, and other revenue per MA/MS policy represents revenue from Population Health, production bonuses, marketing development funds, lead generation revenue, and adjustments from the Company’s reassessment of its cohorts’ transaction prices. Total operating expenses per MA/MS policy represents all of the operating expenses within Senior and Healthcare Services. The revenue to customer acquisition cost (“CAC”) multiple represents total revenue as a multiple of total marketing acquisition cost, which represents the direct costs of acquiring leads. These costs are included in marketing and advertising expense within the total operating expenses per MA/MS policy.

The following table shows combined Senior and Healthcare Services consumer per unit economics for the periods presented. Based on the seasonality of Senior and the fluctuations between quarters, we believe that the most relevant view of per unit economics is on a rolling 12-month basis. All per MA/MS policy metrics below are based on the sum of approved MA/MS policies, as both products have similar commission profiles.

Total revenue per MA/MS policy increased 23% for the twelve months ended December 31, 2025, compared to the twelve months ended December 31, 2024, primarily due to the increase in pharmacy revenue. Total operating expenses per MA/MS policy increased 31% for the twelve months ended December 31, 2025, compared to the twelve months ended December 31, 2024, driven by an increase in cost of goods sold-pharmacy revenue for Healthcare Services due to the growth of the business.

Life

Financial Results

The following table provides the financial results for the Life segment for the periods presented:

Operating Metrics

Life premium represents the total premium value for all policies that were approved by the relevant insurance carrier partner and for which the policy document was sent to the policyholder and payment information was received by the relevant insurance carrier partner during the indicated period. Because our commissions are earned based on a percentage of total premium, total premium volume for a given period is the key driver of revenue for our Life segment.

The following table shows term and final expense premiums for the periods presented:

Earnings Conference Call

SelectQuote, Inc. will host a conference call with the investment community on February 5, 2025 beginning at 8:00 a.m. ET. To register for this conference call, please use this link: https://events.q4inc.com/analyst/199368355?pwd=c0a3KINj. After registering, a confirmation will be sent via email, including dial-in details and unique conference call codes for entry. Registration is open through the live call, but to ensure you are connected for the full call we suggest registering at least 10 minutes before the start of the call. The event will also be webcasted live via our investor relations website https://ir.selectquote.com/investor-home/default.aspx.

Non-GAAP Financial Measures

This release includes certain non-GAAP financial measures intended to supplement, not substitute for, comparable GAAP measures. To supplement our financial statements presented in accordance with GAAP and to provide investors with additional information regarding our GAAP financial results, we have presented in this release Adjusted EBITDA, which, when presented on a consolidated basis, is a non-GAAP financial measure. This non-GAAP financial measure is not based on any standardized methodology prescribed by GAAP and is not necessarily comparable to any similarly titled measure presented by other companies. We define Adjusted EBITDA as net income (loss) plus interest expense, income taxes, depreciation and amortization, changes in fair value of warrant liabilities, and certain add-backs for non-cash or non-recurring expenses, including restructuring and share-based compensation expenses. The most directly comparable GAAP measure is net income (loss). We monitor and have presented in this release Adjusted EBITDA because it is a key measure used by our management and Board of Directors to understand and evaluate our operating performance, establish budgets, and develop operational goals for managing our business. In particular, we believe that excluding the impact of these expenses in calculating Adjusted EBITDA can provide a useful measure for period-to-period comparisons of our core operating performance.

A reconciliation of the differences between Adjusted EBITDA and its most directly comparable GAAP measure, net income (loss), is presented below on page 15. The Company is unable to provide a quantitative reconciliation of forward-looking Adjusted EBITDA to its most directly comparable GAAP measure without unreasonable effort because it is not possible to predict certain information included in the calculation of such GAAP measure, including the fair value of outstanding warrants to purchase shares of the Company’s common stock. The unavailable information could have a significant impact on the Company’s GAAP financial results.

Forward Looking Statements

This release contains forward-looking statements. These forward-looking statements reflect our current views with respect to, among other things, future events and our financial performance. These statements are often, but not always, made through the use of words or phrases such as “may,” “should,” “could,” “predict,” “potential,” “believe,” “will likely result,” “expect,” “continue,” “will,” “anticipate,” “seek,” “estimate,” “intend,” “plan,” “projection,” “would” and “outlook,” or the negative version of those words or other comparable words or phrases of a future or forward-looking nature. These forward-looking statements are not historical facts, and are based on current expectations, estimates and projections about our industry, management’s beliefs and certain assumptions made by management, many of which, by their nature, are inherently uncertain and beyond our control. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements. There are or will be important factors that could cause our actual results to differ materially from those indicated in these forward-looking statements, including, but not limited to, the following: our reliance on a limited number of insurance carrier partners and any potential termination of those relationships or failure to develop new relationships; existing and future laws and regulations affecting the health insurance market; changes in health insurance products offered by our insurance carrier partners and the health insurance market generally; insurance carriers offering products and services directly to consumers; changes to commissions paid by insurance carriers and underwriting practices; competition with brokers, exclusively online brokers and carriers who opt to sell policies directly to consumers; competition from government-run health insurance exchanges; developments in the U.S. health insurance system; our dependence on revenue from carriers in our senior segment and downturns in the senior health as well as life, automotive and home insurance industries; our ability to develop new offerings and penetrate new vertical markets; risks from third-party products; failure to enroll individuals during the Medicare annual enrollment period; our ability to attract, integrate and retain qualified personnel; our dependence on lead providers and ability to compete for leads; failure to obtain and/or convert sales leads to actual sales of insurance policies; access to data from consumers and insurance carriers; accuracy of information provided from and to consumers during the insurance shopping process; cost-effective advertisement through internet search engines; ability to contact consumers and market products by telephone; global economic conditions, including inflation; disruption to operations as a result of future acquisitions; significant estimates and assumptions in the preparation of our financial statements; impairment of goodwill; potential litigation and other legal proceedings or inquiries; our existing and future indebtedness; our ability to maintain compliance with our debt covenants; access to additional capital; failure to protect our intellectual property and our brand; fluctuations in our financial results caused by seasonality; accuracy and timeliness of commissions reports from insurance carriers; timing of insurance carriers’ approval and payment practices; factors that impact our estimate of the constrained lifetime value of commissions per policyholder; changes in accounting rules, tax legislation and other legislation; disruptions or failures of our technological infrastructure and platform; failure to maintain relationships with third-party service providers; cybersecurity breaches or other attacks involving our systems or those of our insurance carrier partners or third-party service providers; our ability to protect consumer information and other data; failure to market and sell Medicare plans effectively or in compliance with laws; and other factors related to our pharmacy business, including manufacturing or supply chain disruptions, access to and demand for prescription drugs, changes in reimbursement rates under our contracts with pharmacy benefit managers, and regulatory changes or other industry developments that may affect our pharmacy operations. For a further discussion of these and other risk factors that could impact our future results and performance, see the section entitled “Risk Factors” in the most recent Annual Report on Form 10-K (the “Annual Report”) and subsequent periodic reports filed by us with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on any such forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made, and, except as otherwise required by law, we do not undertake any obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.

About SelectQuote:

Founded in 1985, SelectQuote (NYSE: SLQT) 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. Today, the Company operates an ecosystem offering high touchpoints for consumers across insurance, pharmacy, and virtual care.

With an ecosystem offering engagement points for consumers across insurance, Medicare, pharmacy, and value-based care, the company now has three core business lines: SelectQuote Senior, SelectQuote Healthcare Services, and SelectQuote Life. 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 Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, SelectPatient Management, a provider of chronic care management services, and Healthcare Select which proactively connects consumers with a wide breadth of healthcare services supporting their needs.

View full release here.

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

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

Source: SelectQuote, Inc.

Release – Cardiff Oncology Announces Positive Update from its Randomized Phase 2 Trial of Onvansertib in First-line RAS-mutated mCRC

Research News and Market Data on CRDF

January 27, 2026

PDF Version

– Onvansertib added to FOLFIRI/bev first-line standard of care regimen showed dose-dependent improvement in overall response rates and durability trends as measured by progression-free survival in patients with RAS-mutated mCRC –

– Data support selection of 30 mg onvansertib dose for registrational program in first-line RAS-mutated mCRC –

– Data validate previously reported positive results from Phase 2 trial of onvansertib with FOLFIRI/bev in second-line mCRC bev-naïve patients, as published in the Journal of Clinical Oncology –

– Onvansertib continues to be safe and well-tolerated –

– Company expects to provide final data and registrational plans in first half of 2026 –

– Company to hold conference call today at 8:30 a.m. ET/5:30 a.m. PT –

SAN DIEGO, Jan. 27, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced a positive update from CRDF-004, a randomized dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard of care (SoC) regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line (1L) RAS-mutated metastatic colorectal cancer (mCRC). In an intent-to-treat analysis, the clinical data show dose-dependent benefits across multiple efficacy measures in patients receiving onvansertib with FOLFIRI/bev compared to patients receiving either SoC regimen. In this trial, onvansertib with FOLFIRI/bev also performed better than onvansertib with FOLFOX/bev.

Based on these results, the Company has selected the 30 mg dose of onvansertib with FOLFIRI/bev to bring forward in a registrational trial in 1L patients with RAS-mutated mCRC. Cardiff Oncology plans to initiate a registrational program later this year pending finalization of the trial design in consultation with the FDA, in which the Company expects to compare onvansertib with FOLFIRI/bev to SoC regimens, FOLFIRI/bev or FOLFOX/bev.

“These data demonstrate promising enhanced benefits of onvansertib when combined with FOLFIRI/bev in RAS-mutated mCRC patients,” said Mani Mohindru, PhD, interim Chief Executive Officer. “We observed a consistent, dose-dependent treatment benefit across multiple measures of efficacy, including achieving statistical significance for PFS compared to SoC even with relatively small patient numbers. The 30 mg onvansertib–FOLFIRI/bev arm outperformed both SoC arms with no significant additive toxicity, supporting findings from our previous Phase 2 trial in second-line RAS-mutated mCRC. While we continue to review data from the ongoing trial, our plan is to rapidly move forward with the onvansertib 30 mg dose in combination with FOLFIRI/bev and we believe confirmatory data from a registrational trial has the potential to make this regimen a new SoC for 1L treatment of RAS-mutated mCRC.”


Bev=bevacizumab; BICR=Blinded Independent Central Review; CI=confidence interval; HR=hazard ratio; NR=not reached; Onv=onvansertib; ORR=objective response rate; PFS=progression-free survival; SoC=standard of care.
aORR is confirmed responses
bProgressive disease events were based on combined BICR and Investigator assessments due to very small number of events in BICR assessment. The earliest reported date was used for a conservative estimate.
cSoC is the combination of the FOLFIRI/bev and FOLFOX/bev arms
dPFS HR is the comparison of the onvansertib arm to FOLFIRI/bev
ePFS HR is the comparison of the onvansertib arm to SoC
fFisher’s exact test
gLog-rank test

“There is a clear need for improved first-line treatment options for patients with mCRC, especially the half of those with RAS-mutated disease,” said Dr. J Randolph Hecht, MD, Professor of Clinical Medicine at the David Geffen School of Medicine at UCLA. “Unfortunately, first-line treatment for these patients hasn’t improved significantly for more than two decades. Onvansertib has a novel mechanism of action and these preliminary responses and PFS results in combination with FOLFIRI/bevacizumab are encouraging enough to test in a large Phase 3 trial. If such a trial were positive, it could become a new standard of care for these patients.”

Onvansertib in combination with both chemo/bev regimens was well-tolerated. There were no major or unexpected toxicities observed and no additive adverse events. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event across both the onvansertib combination and standard of care arms.

Conference Call and Webcast
Cardiff Oncology will host a conference call and live webcast today, January 27, 2026 at 8:30 a.m. ET / 5:30 a.m. PT. Individuals interested in listening may do so by using the link in the “Events” section of the Company’s website. A replay will be available in the investor relations section on the Company’s website following the completion of the call.

CRDF-004 Trial Design
The CRDF-004 Phase 2 trial was designed to evaluate two doses of onvansertib to identify the lowest maximally effective dose and to assess the safety, efficacy, and pharmacokinetics of onvansertib in combination with FOLFIRI/bevacizumab or FOLFOX/bevacizumab in first-line patients with KRAS- or NRAS-mutated metastatic colorectal cancer (mCRC). The trial’s endpoints include objective response rate (ORR), progression-free survival (PFS), duration of response, and safety.

For additional information about the trial, please visit www.clinicaltrials.gov (Trial ID: NCT06106308).

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer. It is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML). Promising monotherapy clinical results from an ongoing CMML trial were recently presented at the American Society of Hematology annual meeting in December 2025. CMML represents a rare disease with significant unmet need.

About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.

For more information, please visit https://www.cardiffoncology.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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Investor Contact:
Candice Masse
Astr Partners
candice.masse@astrpartners.com

Media Contact:
Amy Bonanno
Lyra Strategic Advisory
abonanno@lyraadvisory.com

Release – Cardiff Oncology Announces Executive Leadership Changes as it Transitions to Late-Stage Clinical Development

Research News and Market Data on CRDF

January 27, 2026

PDF Version

SAN DIEGO, Jan. 27, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced a leadership transition designed to support the Company’s next phase of growth and advancement toward late-stage development and key clinical and corporate milestones.

Mani Mohindru, PhD, a member of Cardiff Oncology’s Board of Directors since 2021 and a seasoned biotech executive, has been appointed interim Chief Executive Officer, effective immediately. Mark Erlander, PhD, Chief Executive Officer, and James Levine, Chief Financial Officer, have stepped down from their respective roles.

As part of this transition, Ms. Brigitte Lindsay has been promoted to the role of Chief Accounting Officer, ensuring continuity within the finance function. She has been with the Company for more than 14 years and was most recently the Senior Vice President of Finance. The Company has initiated a search for a permanent Chief Executive Officer and Chief Financial Officer.

Cardiff Oncology’s lead product candidate, onvansertib, a highly specific, oral PLK1 inhibitor, is currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer (mCRC) and is also being evaluated as a single agent and in combinations across multiple additional cancers in investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, triple-negative breast cancer, and chronic myelomonocytic leukemia. The leadership transition reflects the Company’s focus on execution and clinical advancement as its programs mature.

“As Cardiff Oncology prepares for the next stage of clinical and corporate development, the Board concluded that this was the right moment to align executive and financial leadership with the Company’s evolving needs,” said Rodney S. Markin, MD, PhD, Chairman of the Board. “We want to express our sincere gratitude to Mark and Jamie for their significant contributions in guiding Cardiff to where it stands today—especially in the progress of our lead product candidate in first-line RAS-mutated mCRC, an area of high unmet need where there have not been any significant advancements in many years. Looking forward, we are confident in Dr. Mohindru’s ability to lead the Company at this key moment in onvansertib’s clinical development, as she brings a rare combination of deep scientific training, operational leadership, and capital markets expertise.”

“Cardiff Oncology has built a strong scientific and clinical foundation around PLK1 inhibition, with onvansertib demonstrating encouraging activity in a challenging to treat patient population,” said Mani Mohindru, PhD, interim Chief Executive Officer. “Given onvansertib’s activity in RAS-mutated mCRC as well as encouraging single agent data, there is potential to extend its benefit to other solid tumors and hematologic malignancies. I look forward to working closely with the Board and the team to sharpen our strategic priorities, advance our clinical programs, and thoughtfully position the Company for late-stage development while maintaining a disciplined approach to capital and execution.”

Dr. Mohindru is an experienced biotechnology executive with leadership experience spanning drug development, corporate strategy, and capital markets. She is the founder of Roshon Therapeutics, a private biotechnology company focused on developing novel therapies for cancer and inflammatory diseases, and currently serves on the Board of Directors of CytomX Therapeutics, Inc. (Nasdaq: CTMX). Previously, Dr. Mohindru served as Chief Executive Officer and Board Director of Novasenta and CereXis, and held senior leadership roles at public biotechnology companies including Cara Therapeutics, Inc. and Curis, Inc.

Earlier in her career, Dr. Mohindru was an equity research analyst covering the biotechnology sector at UBS, Credit Suisse, and ThinkEquity. She currently serves on the Executive Advisory Board of the CLP Institute at Northwestern University and the Scientific Investment Advisory Committee of the Gates Institute at the University of Colorado. Dr. Mohindru holds a PhD in Neurosciences from Northwestern University, as well as a BS in Human Biology and a Master’s degree in Biotechnology from the All India Institute of Medical Sciences in New Delhi, India.

About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.

For more information, please visit https://www.cardiffoncology.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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several 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, our ability to conduct a successful search for and hire a permanent CEO and CFO, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Investor Contact:
Candice Masse
Astr Partners
candice.masse@astrpartners.com

Media Contact:
Amy Bonanno
Lyra Strategic Advisory
abonanno@lyraadvisory.com

Release – Greenwich LifeSciences Provides Update on FLAMINGO-01 Cash Burn Rate and Financing Strategy

Research News and Market Data on GLSI

 Download as PDFJanuary 27, 2026 6:00am EST

STAFFORD, Texas, Jan. 27, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided additional updates on its cash burn rate and financing strategy.

The Company’s ATM financing vehicle allows the Company to sell its common stock directly into the trading market at market price. The amount raised through our ATM for 2025 exceeded the Company’s 2025 cash burn rate of approximately $9.5 million, leading to a year end cash balance of approximately $6 million as of December 31, 2025. Furthermore, the Company more than doubled its cash balance as of the close of business on January 23, 2026, to approximately $12.5 million, having raised approximately $7 million in the first three weeks of January 2026 through the ATM. The above preliminary financial figures are unaudited and are subject to change following completion of the Company’s financial audit for 2025.

CEO Snehal Patel commented, “Our financing strategy in January 2026 has been quite impressive so far without daily or constant use of the ATM. The current cash balance of $12.5 million could exceed the Company’s cash needs for all of 2026, given the $9.5 million annual burn rate in 2025 and the modest increase in cash needs over the $7 million annual burn rates in 2024 and 2023. We believe the Company’s lean structure and ongoing cost saving initiatives have been instrumental in this strategy, including the increasing number of patients entering the less expensive booster phase of Flamingo-01, due to less frequent site visits and vaccinations, and fewer more expensive site start-up costs.”

Mr. Patel further added, “While our cash burn rates in 2026 and 2027 are projected to increase, the expected ongoing use of the ATM to sustain or grow the current cash balance may reduce the likelihood of the Company doing a large near term financing in 2026 or 2027, though there can be no assurance of this. Since the follow-on offering in 2020, we primarily utilized the ATM with initially Jefferies and more recently H.C. Wainwright to fund the Company. Continued use of the ATM may provide a bridge to non-dilutive funding, such as strategic/licensing partnerships or debt/royalty financing vehicles, that would further fund FLAMINGO-01 and potential commercial launch activities.”

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 600 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

  • In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
  • This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
  • The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

  • 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
  • The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

About Greenwich LifeSciences, Inc.

Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.

Forward-Looking Statement Disclaimer

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.

Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: info@greenwichlifesciences.com

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: dave@redchip.com

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Source: Greenwich LifeSciences, Inc.

Released January 27, 2026

Release – GeoVax Highlights 2026 as a Pivotal Year for Progress

Research News and Market Data on GOVX

Management Highlights 2026 as a Portfolio-Wide Inflection Year Driven by Regulatory De-Risking, Clinical Readouts, and Scalable Manufacturing

ATLANTA, GA – January 20, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today provided a post-conference update following the J.P. Morgan Healthcare Conference Week in San Francisco, where, during investor, banker and partner engagements, the Company outlined 2026 as a pivotal inflection year driven by multiple late-stage clinical, regulatory, and manufacturing milestones across its diversified portfolio.

“GeoVax enters 2026 with increasing clarity on execution, prioritization, and value creation,” said David Dodd, Chairman & CEO of GeoVax. “With GEO-MVA representing an expedited path to potential commercialization, alongside multiple clinical data readouts relative to GEO-CM04S1, our multi-antigen COVID-19 vaccine and, the anticipated initiation of the Phase 2 Gedeptin® trial, we believe that this year will provide a meaningful convergence of regulatory, clinical, and manufacturing catalysts for the Company.”

Dodd added, “We were particularly encouraged by the level of interest and the quality of discussions we had during JP Morgan/Biotech Showcase with investors, potential strategic partners, and global health stakeholders. The feedback we received around GeoVax’s progress, our differentiated platforms, and our regulatory momentum, especially for GEO-MVA, reinforces our confidence that 2026 has the potential to be a pivotal breakout year for the Company.”

GEO-MVA (Mpox & Smallpox): Expedited Path to Commercialization in a Currently Constrained Market

GEO-MVA is GeoVax’s most advanced program and represents the Company’s near-term opportunity for potential commercialization. The global Mpox and smallpox vaccine market remains constrained by reliance on a single foreign manufacturer whose production capacity has proven insufficient to meet sustained worldwide demand, particularly during periods of expanding or recurring outbreaks. This structural supply imbalance underscores both the commercial opportunity and the public health imperative for an additional, scalable MVA vaccine source.

Following receipt of supportive Scientific Advice from the European Medicines Agency (EMA), GeoVax has regulatory alignment on a single, pivotal Phase 3 immunobridging study versus the approved MVA vaccine. This guidance supports an expedited development pathway and meaningfully de-risks the regulatory route toward potential approval and revenue generation.

Key 2026 milestones for GEO-MVA include:

  • Initiation of the pivotal Phase 3 immunobridging trial, expected in the second half of 2026
  • Continued engagement with European and global health authorities seeking to diversify Mpox and smallpox vaccine supply in light of ongoing global demand pressures
  • Advancement toward a U.S.-sourced vaccine supply model addressing both civilian public health needs and biodefense preparedness

With GEO-MVA clinical material manufactured and fill-finish completed, the program is positioned to transition from development into Phase 3 execution in 2026, reinforcing its role as GeoVax’s lead value driver and shortest path to potential commercialization.

Gedeptin® (Oncology): Advancing Toward Combination-Driven Value Inflection

In oncology, GeoVax continues to advance Gedeptin®, its gene-directed enzyme prodrug therapy, following encouraging safety and tumor-response signals from prior clinical studies.

Key 2026 inflection points include:

  • Publication of results from the recently completed Gedeptin trial
  • Initiation of a Phase 2 study evaluating Gedeptin in combination with an immune checkpoint inhibitor as a potential first-line therapy for head and neck cancer by year-end
  • Updates on preclinical evaluations of Gedeptin in combination with immune checkpoint inhibitors, informing potential expansion into additional solid tumor indications.

GeoVax continues to pursue a partnership-oriented development strategy for Gedeptin, designed to advance the program efficiently while preserving long-term upside.

GEO-CM04S1 (COVID-19): Multiple Clinical Data Readouts

GeoVax’s next-generation COVID-19 vaccine, GEO-CM04S1, continues to advance as a differentiated, multi-antigen (Spike + Nucleocapsid) candidate designed to address unmet needs in immunocompromised and high-risk populations inadequately served by current single-antigen vaccines.

During 2026, the Company expects:

  • Clinical data readouts from ongoing Phase 2 trials
  • Continued evaluation of GEO-CM04S1 as both a primary and booster vaccine in immunocompromised populations
  • Additional translational insights supporting future regulatory and partnering discussions

AGE1 Continuous Cell-Line Manufacturing: Advancing MVA Scalability and Supply

The AGE1 continuous avian cell-line manufacturing process has the potential to significantly improve how MVA-based vaccines are produced by addressing historical scalability and supply constraints. By enabling continuous, cell-line–based production, AGE1 provides a more reliable and scalable alternative to traditional chicken embryo fibroblast–dependent methods.

AGE1 is directly integrated into the GEO-MVA program, strengthening GeoVax’s ability to support sustained commercial supply, rapid scale-up, and domestic manufacturing – capabilities increasingly critical as global demand for Mpox and smallpox vaccines exceeds available supply.

Manufacturing progress anticipated during 2026 includes:

  • Continued optimization of the AGE1 process to support commercial-scale GEO-MVA production
  • Advancement of AGE1 as a scalable, U.S.-based manufacturing solution aligned with pandemic preparedness and supply-chain resilience priorities

Positioned for Execution

Collectively, these milestones reflect GeoVax’s transition into a catalyst-rich period where multiple programs are advancing in parallel toward late-stage development, regulatory decision points, and potential commercialization pathways.

“As we emphasized during JP Morgan/Biotech Showcase Week, GeoVax has moved beyond platform validation,” Dodd added. “We are now executing against clearly defined milestones, with GEO-MVA leading the portfolio and multiple additional programs advancing toward value-inflection events in 2026 and beyond.”

Dodd concluded, “As we move through 2026, GeoVax is entering a phase where years of platform development, regulatory engagement, and manufacturing investment begin to translate into tangible outcomes. With GEO-MVA advancing along a clearly defined path toward commercialization, multiple clinical data readouts expected across our COVID-19 and oncology programs, and a scalable manufacturing foundation in place, we believe GeoVax is well positioned for a pivotal year of execution and value creation.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

info@geovax.com

678-384-7220

Media Contact:

Jessica Starman

media@geovax.com 

Release – MAIA Biotechnology Advances Ateganosine Cancer Treatment Program, Outlines Targeted 2026 Clinical Milestones and Growth Momentum

Research News and Market Data on MAIA

January 20, 2026 10:15am EST Download as PDF

High probability of technical success in pivotal Phase 3 trial based on unmatched efficacy data for third-line non-small cell lung cancer (NSCLC) treatment

FDA’s Fast Track designation for ateganosine in NSCLC advances concurrent Phase 2 expansion and Phase 3 trials along strategic regulatory pathways

Strong momentum toward goal of early commercial approval

Potential breakthrough therapeutic for estimated $50+ billion global immunotherapy market;
first and only telomere-targeting anticancer agent in clinical development anywhere

CHICAGO, Jan. 20, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today provided a corporate update on 2025 achievements and highlighted key targeted milestones and growth catalysts for 2026.

“MAIA’s strong clinical execution in 2025 delivered exceptional efficacy data for ateganosine sequenced with a checkpoint inhibitor, including disease control, response rates, and survival data well above standard of care benchmarks,” said MAIA founder and CEO Vlad Vitoc, M.D. “The results clearly differentiate our novel telomere-targeting science and support the U.S. FDA’s Fast Track designation granted in 2025, positioning ateganosine for potential eligibility under the Accelerated Approval and Priority Review regulatory pathways.

“Our statistical assessments of ateganosine imply a high probability of technical success in our concurrent Phase 3 and Phase 2 trials. As our first-in-class small molecule advances toward potential early commercial approval—possibly within 18 to 24 months—we believe our strong execution is driving a clear value-creation inflection point, with meaningful long-term benefits for stockholders.”

2025 Achievements

  • Secured FDA Fast Track designation for ateganosine as a treatment for NSCLC. Fast Track expedites the review of investigational drugs that treat serious conditions and fill an unmet medical need.
  • Marked a major clinical milestone by initiating a full approval THIO-104 Phase 3 trial in third-line (3L) NSCLC patients resistant to immunotherapy and chemotherapy.
  • Advanced the THIO-101 Phase 2 clinical trial to the Part C expansion phase, substantially increasing the patient pool to include countries in Asia and Europe. The expansion trial positions the ateganosine program for broader regulatory and commercial relevance.
  • Awarded $2.3 million grant from the National Institutes of Health (NIH) for the expansion of Phase 2 trial. The grant is intended to support expenses related to the enrollment of U.S. patients who are resistant to chemo and immunotherapy.
  • Validated telomere-targeting as a differentiated therapeutic approach with applicability to multiple high mortality cancers. To our knowledge, ateganosine remains the only direct telomere-targeting anticancer agent in clinical development anywhere.
  • Established checkpoint inhibitor combination partnerships through a master agreement with Roche for atezolizumab and a clinical supply agreement with BeOne Medicines for tislelizumab, enabling multiple future combination trials.
  • Raised approximately $17.6 million from capital raises throughout 2025, with participation by members of the Board in nearly all transactions. This signals strong conviction and confidence in the long-term value creation potential of the ateganosine platform. As of December 31,2025, MAIA’s directors and officers hold more than 5 million shares or approximately 13% of the Company.

Targeted 2026 Milestones

  • Initial measures of efficacy from Phase 3 study. Interim disease control rates (DCR), overall response rates (ORR) and progression free survival (PFS) analysis of ateganosine compared to the control arm will support regulatory discussions. Strong interim data could lead to early full commercial approval.
  • Conclusion of Part C of Phase 2 study. Expansion of the trial provides additional clinical efficacy data to support regulatory review for commercial approval.
  • Engage in regulatory interactions with the FDA. Expand ongoing FDA dialogue under the Fast Track designation, including discussions around trial enhancements and prospects for Accelerated Approval and Priority Review.
  • Clinical development of second-generation molecules to start in Phase 1 trials. Additional small molecules fully developed in-house with better expected efficacy compared to ateganosine.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

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Source: MAIA Biotechnology, Inc.

Released January 20, 2026

Release – The Oncology Institute Reaffirms 2025 Guidance and Provides Preliminary 2026 Outlook

Research News and Market Data on TOI

Jan 12, 2026

PDF Version

CERRITOS, Calif., Jan. 12, 2026 (GLOBE NEWSWIRE) — The Oncology Institute, Inc. (NASDAQ: TOI) (“TOI” or the “Company”), one of the largest value-based oncology groups in the United States, today reaffirmed 2025 guidance and provided its preliminary 2026 outlook.

2026 Outlook

For 2026, TOI anticipates that total revenue will be in the range of $630 million to $650 million, reflecting 28% growth from the midpoint of 2025 and 2026 guidance ranges, and including approximately $150 million of Capitation revenue in 2026. This expected top-line increase reflects continued expansion of delegated contracts in Florida, the annualized impact of strong volumes in the Dispensary segment during the second half of 2025, and broader organic growth and new contract wins across the platform. While these drivers are expected to contribute meaningfully to revenue in 2026, the Company anticipates profitability from newly onboarded delegated contracts to build progressively over the course of the year, with more fully realized economics in 2027.

Based on these factors, and inclusive of targeted investments to support TOI’s ongoing growth, we expect Adjusted EBITDA for 2026 to be in the range of $0 million to $9 million. At the midpoint of this range, 2026 would represent TOI’s first full year of Adjusted EBITDA profitability as a public company.

TOI uses Adjusted EBITDA, 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 to net (loss) income, the most directly comparable GAAP financial measure, 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.

Longer-Term Outlook

Looking beyond 2026, we believe the Company is well positioned for continued expansion.

We seek to grow total revenue at an annual rate of approximately 20% through 2028 and believe Capitation and Dispensary revenue could increase to approximately 30% and 50% of total revenue, respectively. This projection reflects the ongoing migration of the business model towards comprehensive oncology care in an increasingly value-based landscape.

As TOI continues to scale, we believe margins have the potential to expand through 2028 to the mid-single-digit range as a percentage of revenue, driven by the expansion of the asset-light delegated capitated model, and continued SG&A leverage.

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. 

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 outlook, 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, with such risks and uncertainties increasing with the passage of time for longer-term outlook, including the accuracy of the assumptions underlying the 2026 full fiscal year outlook and the longer-term outlook with respect to Adjusted EBITDA and margins 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.

Financial Information: Non-GAAP Financial Measures

Some of the financial information and data contained in this press release, such as Adjusted EBITDA, have not been prepared in accordance with United States generally accepted accounting principles (“GAAP”). TOI’s non-GAAP financial measures may be different from non-GAAP financial measures used by other companies. The presentation of non-GAAP financial measures is not intended to be considered in isolation or as a substitute for, or superior to, financial measures determined in accordance with GAAP. Because of the limitations of non-GAAP financial measures, you should consider the non-GAAP financial measures presented in this press release in conjunction with TOI’s financial statements and the related notes thereto.

TOI believes that the use of Adjusted EBITDA provides an additional tool to assess our operations and results of our performance, to plan and forecast future periods, and factors and trends in, and in comparing our financial measures with, other similar companies, many of which present similar non-GAAP financial measures to investors. The principal limitation of Adjusted EBITDA is that it excludes significant expenses and income that are required by GAAP to be recorded in TOI’s financial statements.

TOI defines Adjusted EBITDA as net (loss) income plus depreciation, amortization, interest, taxes, non-cash items, share-based compensation, goodwill impairment charges, change in fair value of liabilities, unrealized gains or losses on investments and other adjustments to add-back the following: consulting and legal fees related to acquisitions, one-time consulting and legal fees related to certain advisory projects, software implementations and debt or equity financings, severance expense and temporary labor and recruiting charges to build out our corporate infrastructure.

Contacts

Media
The Oncology Institute, Inc.
marketing@theoncologyinstitute.com

Investors
ICR Healthcare
TOI@icrhealthcare.com

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

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

Genmab to Acquire Merus in $8 Billion Deal, Strengthening Oncology Pipeline

Danish biotechnology company Genmab (Nasdaq: GMAB) has agreed to acquire Dutch oncology firm Merus (Nasdaq: MRUS) in an all-cash transaction valued at roughly $8 billion, a move that significantly expands Genmab’s late-stage pipeline and accelerates its push toward a fully owned operating model.

Under the terms of the deal, Genmab will pay $97.00 per share for all outstanding common shares of Merus, representing a premium of more than 40% over Merus’ most recent closing price. The boards of both companies have unanimously approved the transaction, which is expected to close by the first quarter of 2026 pending regulatory and shareholder approvals.

The acquisition brings Merus’ lead asset, petosemtamab, into Genmab’s pipeline. The bispecific antibody therapy, currently in Phase 3 clinical trials, has received two Breakthrough Therapy Designations from the U.S. Food and Drug Administration for treatment of head and neck cancers. Recent Phase 2 data presented at the 2025 ASCO meeting indicated promising efficacy, with outcomes surpassing standard of care benchmarks.

The addition of petosemtamab is expected to bolster Genmab’s transition to a fully owned model, reducing reliance on partnerships and collaborations. By 2027, Genmab anticipates four proprietary programs reaching the commercial stage, positioning the company for multiple new product launches within oncology.

Petosemtamab’s potential launch as early as 2027 could deliver significant commercial impact, with projections suggesting annual sales of $1 billion by 2029 and the possibility of multi-billion-dollar revenues in the longer term. Genmab expects the acquisition to become accretive to EBITDA before the end of the decade.

The $8 billion consideration will be financed through a combination of cash on hand and approximately $5.5 billion in debt, backed by commitments from Morgan Stanley Senior Funding. Genmab stated it remains committed to deleveraging, with a target of reducing gross leverage below three times within two years of closing.

A tender offer for Merus shares will launch in the coming weeks. If successful, the transaction will result in Merus becoming a wholly owned subsidiary of Genmab. Shareholders who do not tender their shares are expected to receive equivalent value through statutory buy-out proceedings in the Netherlands.

The deal highlights the intense competition among biotech companies to secure late-stage oncology assets with strong regulatory momentum. By integrating Merus’ multispecific antibody expertise, Genmab gains not only a promising drug candidate but also a platform that complements its own antibody development technologies.

For Merus, the acquisition provides the scale and resources of a global biotechnology leader to advance petosemtamab through late-stage development, regulatory review, and potential commercialization.

With a strong balance sheet, an expanded pipeline, and an emphasis on proprietary innovation, Genmab is positioning itself to compete more directly with larger global oncology players in the second half of the decade.

Greenwich LifeSciences, Inc. (GLSI) – Fast Track Designation Gives Benefits Now And In The Future


Monday, September 15, 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.

GLSI-100 Received Fast Track Designation. Greenwich LifeSciences announced that GLSI-100 has received Fast Track designation from the FDA. In the near term, this designation allows GLSI increased communications and more FDA meetings regarding regulatory requirements for its clinical trial data and use of biomarkers. Once the FLAMINGO-01 trial is completed, GLSI will be eligible to apply for Accelerated Approval and Priority Review, potentially shortening the time to market.

The Designation Mirrors The Trial Entry Criteria. GLSI-100 has received Fast Track Designation from the FDA for the treatment of “patients with HLA-A*02 genotype and HER2-positive breast cancer who have completed treatment with standard of care HER2/neu targeted therapy to improve invasive breast cancer free survival…” This includes the clinical trial entry criteria and endpoints for the current double-blind arms of the trial.


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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. 

Eledon Pharmaceuticals (ELDN) – Meeting Highlights Tegoprubart Data Milestones and New Indications


Thursday, July 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.

R&D Day Highlighted Science, Current Trials, Future Indications. We attended the Eledon R&D Day on July 9 to hear and evaluate the progress in tegoprubart development. The presentations focused on the current clinical indications in renal transplantation, islet cell transplantation, xenotransplants, and plans for liver and other solid organ transplants. Conference presentation dates for upcoming data announcements were also announced.

Phase 1b Data Update Is Planned For August. The Phase 1b open-label trial has been expanded to enroll up to 36 patients, an increase from the original 9 patients. Data is scheduled for presentation at the World Transplant Congress on August 9, 2025. Previous data presentations have included 13 patients. We expect to see follow-up data from more patients treated longer, with data from additional patients beyond the initial 12-month trial duration.


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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. 

DLH Holdings (DLHC) – A Steady Accumulator


Monday, June 02, 2025

DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

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

An Accumulator. Mink Brook Capital has been a steady accumulator of DLHC shares, amassing 2,164,058 DLHC shares, representing approximately 15% of the outstanding shares. Mink Brook first filed a schedule 13G back in early July 2024, disclosing a 5% holding of DLHC shares. The investment firm has continuously added to its stake since then. Mink Brook is the second largest holder of DLHC shares, only behind long-term holder Wynnefield Capital, owner of approximately 25.6% of the shares.

Who Is Mink Brook? Florida based Mink Brook was founded in May 2019 by William Mueller. Mr. Mueller had spent the past decade successfully investing and advising capital in the small-cap space. He desired to form an investment firm that would provide investors with idiosyncratic, uncorrelated returns by focusing on companies outside of major indexes. As of March 31st, the investment management firm had 32 positions with a market value of $95 million. Mink Brook’s DLH holding was the manager’s sixth largest by market cap.


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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. 

Release – Zomedica Unveils Exclusive Fourth Friday at Four Webinar Series to Explore Cutting-Edge Veterinary Innovations

Research News and Market Data on ZOMDF

Engaging Sessions to Highlight Game-Changing Technologies, Expert Insights, and Growth Opportunities in Animal Health Featuring Zomedica Products

ANN ARBOR, MI / ACCESS Newswire / May 19, 2025 / Zomedica Corp. (OTCQB:ZOMDF) (“Zomedica” or the “Company”), a veterinary health company offering point-of-care diagnostic and therapeutic products for equine and companion animals, today announced the launch of a new monthly webinar series designed to highlight its innovative product portfolio, introduce key personnel, showcase manufacturing capabilities, and educate investors and strategic partners on the company’s long-term growth strategy.

This exclusive webinar series scheduled for the fourth Friday of every month beginning May 23rd, offers a front-row seat to Zomedica’s game-changing technologies and strategic vision, providing veterinarians, investors, and industry leaders with an unparalleled opportunity to stay ahead of the curve in animal healthcare. Attendees will gain first-hand insights into cutting-edge advancements that are shaping the future of veterinary medicine while discovering how Zomedica is driving innovation, expanding its market presence, and delivering solutions that improve patient outcomes.

Each engaging session will dive deep into Zomedica’s groundbreaking technologies, including the:

  • PulseVet® Shock Wave system – A revolutionary, non-invasive therapy accelerating healing in musculoskeletal conditions, setting new standards in veterinary therapeutics.
  • Assisi Loop® and Calmer Canine products – Advanced tPEMF™ (Targeted Pulsed Electromagnetic Field) therapy devices that provide drug-free, highly effective pain and inflammation management, as well as the Calmer Canine therapy for behavioral separation anxiety.
  • TRUFORMA® Diagnostic Platform – A next-generation in-clinic system offering unique, precise, rapid diagnostic testing to support complex veterinary cases with unparalleled accuracy at the point of care.
  • TRUVIEW® Digital Cytology System: Best-in-class imaging and the only fully automated slide prep solution-ensuring consistent quality, telepathology-backed confidence, and a streamlined workflow for faster, more accurate diagnoses in veterinary medicine.
  • VETGuardian® No-Touch Monitoring System – A state-of-the-art, contact-free monitoring solution ensuring continuous remote tracking of vital signs for enhanced patient care.
  • VETIGEL® – An innovative, plant-based hemostatic gel designed for rapid and effective bleeding control, revolutionizing wound management in veterinary medicine.

“Zomedica’s monthly webinar series isn’t just about showcasing our products-it’s about building a community of forward-thinking professionals and investors dedicated to advancing animal healthcare,” said Larry Heaton, CEO of Zomedica. “Through these interactive sessions, we are offering an exclusive look at our industry-leading technologies, expert-driven discussions, and our commitment to driving growth and innovation in veterinary medicine.”

Designed to be interactive and insightful, each webinar will feature product demonstrations, in-depth discussions with industry experts, and Q&A opportunities with Zomedica’s leadership team. Investors and strategic partners will gain a deeper understanding of the company’s expanding market influence, robust R&D pipeline, and vision for sustainable revenue growth and shareholder value.

Webinar Registration & Details

Don’t miss this opportunity to connect with industry experts, discover groundbreaking technologies, and explore new possibilities in veterinary healthcare. The series is open to veterinary professionals, industry partners, investors, and all who are interested in improving the lives of our family pets.

To secure your spot in the upcoming sessions, click on the link below https://us02web.zoom.us/webinar/register/WN_lUpmJTicRliHUCVyz6JEbg or visit www.investors.zomedica.com.

About Zomedica

Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi® Loop line of therapeutic devices and the TRUFORMA® diagnostic platform, the TRUVIEW® digital cytology system, and the VetGuardian® no-touch monitoring system, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. Zomedica grew revenue 8% in 2024 to $27 million and maintains a strong balance sheet with approximately $65 million in liquidity as of March 31, 2025. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information visit www.zomedica.com.

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Cautionary Note Regarding Forward-Looking Statements

Except for statements of historical fact, this news release contains certain “forward-looking information” or “forward-looking statements” (collectively, “forward-looking information”) within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur and include statements relating to our expectations regarding future results. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance, or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.

Forward-looking information is based on the opinions and estimates of management at the date the statements are made, including assumptions with respect to economic growth, demand for the Company’s products, the Company’s ability to produce and sell its products, sufficiency of our budgeted capital and operating expenditures, the satisfaction by our strategic partners of their obligations under our commercial agreements and our ability to realize upon our business plans and cost control efforts.

Our forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: the outcome of clinical studies, the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work and verification and validation studies; uncertainty as to the timing and results of commercialization efforts, including international efforts, as well as the cost of commercialization efforts, including the cost to develop an internal sales force and manage our growth; uncertainty as to our ability to realize the anticipated growth opportunities from our acquisitions; uncertainty as to our ability to supply products in response to customer demand; supply chain risks associated with tariff changes;; uncertainty as to the likelihood and timing of any required regulatory approvals, and the availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; veterinary acceptance of our products and purchase of consumables following adoption of our capital equipment; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; performance by our strategic partners of their obligations under our commercial agreements, including product manufacturing obligations; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to any required clinical trials and regulatory approvals, risks relating to the safety and efficacy of our products, the use of our products, intellectual property protection, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR+ at www.sedarplus.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.

The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.

Investor Relations Contact:

Zomedica Investor Relations
investors@zomedica.com
1-734-369-2555

SOURCE: Zomedica Corp.