分组1 - MARKER THERAPEUTICS reported a quarterly loss of $0.04 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.21, representing an earnings surprise of +80.49% [1] - The company posted revenues of $1.1 million for the quarter ended December 2025, exceeding the Zacks Consensus Estimate by 83.83%, although this is a decline from year-ago revenues of $2.25 million [2] - The stock has underperformed the market, losing about 8.7% since the beginning of the year compared to the S&P 500's decline of 1.9% [3] 分组2 - The current consensus EPS estimate for the upcoming quarter is -$0.22 on revenues of $0.6 million, and for the current fiscal year, it is -$1.86 on revenues of $2.3 million [7] - The Medical - Drugs industry, to which MARKER THERAPEUTICS belongs, is currently ranked in the top 36% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8]

Exhibit 99.1 Marker Therapeutics Reports Year-End 2025 Corporate and Financial Results Phase 1 APOLLO data update demonstrated encouraging clinical activity with a 66% objective response rate in relapsed non- Hodgkin lymphoma, including 50% complete responses Research published in Nature Medicine highlighted promising results of multi-antigen targeted T cells in pancreatic cancer Strengthened manufacturing capabilities through collaboration with Cellipont Bioservices and expanded Board of Directors with app ...

Phase 1 APOLLO data update demonstrated encouraging clinical activity with a 66% objective response rate in relapsed non-Hodgkin lymphoma, including 50% complete responses Research published in Nature Medicine highlighted promising results of multi-antigen targeted T cells in pancreatic cancer Strengthened manufacturing capabilities through collaboration with Cellipont Bioservices and expanded Board of Directors with appointment of Kathryn Penkus Corzo HOUSTON, March 18, 2026 (GLOBE NEWSWIRE) -- Marker Ther ...

Product Development and Clinical Trials - The company is advancing two product candidates for three clinical indications as part of its MAR-T cell program, focusing on autologous MAR-T cell therapy for lymphoma and pancreatic cancer (MT-601) and an off-the-shelf product (MT-401-OTS) for AML or MDS[16]. - In the Phase 1 APOLLO study, 66% of NHL patients achieved objective responses, with 50% demonstrating complete response, and durable responses were observed in five patients for over six months[26]. - The Phase 1/2 clinical trial (TACTOPS) for MT-601 in pancreatic cancer showed a disease control rate of 84.6% when combined with frontline chemotherapy, with no cytokine release syndrome or neurotoxicity reported[25]. - The FDA granted orphan drug designation to MT-601 for pancreatic cancer treatment and cleared the IND application for the PANACEA study, which will assess MT-601 in combination with chemotherapy[27]. - The company received a $9.5 million grant from CPRIT and a $2 million grant from NIH to support the clinical investigation of MT-601 in metastatic pancreatic cancer[27]. - The MT-401-OTS program aims to provide a fast treatment option for AML or MDS patients, with the potential for large-scale manufacturing and treatment initiation within 72 hours[28]. - The first patient in the OTS program was treated in October 2025, with preliminary safety data consistent with the favorable profile of MAR-T cells[29]. - The company plans to explore new product opportunities by customizing targeted antigens to expand the indications for MAR-T cell products[38]. - The strategy includes expediting clinical development and regulatory approval of lead product candidates, with a focus on advancing MT-601 and the OTS program[35]. - The company is advancing two MAR-T cell therapies: autologous MAR-T targeting multiple antigens and off-the-shelf (OTS) MAR-T with a pre-manufactured inventory[46][47]. - In a Phase 1 clinical trial for lymphoma, 6 out of 15 evaluable patients achieved complete responses (CR), with no relapses reported among CR patients, contrasting with a typical 30% relapse rate in CAR-T studies[54]. - The MAR-T cell therapy demonstrated a 77% estimated two-year overall survival rate in post-transplant AML patients, with 11 out of 15 remaining alive at a median follow-up of 1.9 years[72]. - In the pancreatic cancer trial, significant expansion of MAR-T cells was observed in patients responding to therapy, with no cytokine release syndrome or neurotoxicity reported[67][69]. - The clinical trials conducted by BCM showed significant in vivo expansion of MAR-T cells, indicating a promising therapeutic effect across various cancer indications[58]. - The company has not previously submitted a biologics license application, which requires extensive data to establish safety and effectiveness, complicating the regulatory approval process[182]. - Clinical trials are subject to numerous risks, including delays in recruitment and completion, which could harm commercial prospects and increase costs[186]. - The company may face delays in clinical trials due to challenges in patient enrollment, competition with other trials, and unforeseen events[195]. - The company has experienced delays in clinical trials due to COVID-19 and FDA requirements, impacting cost estimates and timelines[188]. - The results of earlier trials may not predict future outcomes, and setbacks can occur at any stage of the clinical trial process[193]. Manufacturing and Production - The company has optimized the MAR-T cell manufacturing process, reducing the total manufacturing time from 36 days to nine days, resulting in a four-fold increase in potency in vitro[37]. - The manufacturing process for MAR-T cells is designed to select and expand T cells specific for targeted antigens, aiming to restore their functionality and achieve the required patient dose[76]. - The average patient product contains approximately 4,000 different T cell clonotypes specific to 5 antigens[79]. - The company expects substantial manufacturing costs for its MAR-T cell product candidates due to patient-specific production and complex processing steps[188]. - Manufacturing capabilities may be impacted by cost overruns, unexpected delays, and regulatory approval processes, potentially leading to increased clinical trial costs and delays in product commercialization[209]. - The company relies on a limited number of vendors for critical materials and equipment, which poses risks to the manufacturing and supply of product candidates[210]. - Sole-source vendor reliance could adversely affect the ability to meet demand for product candidates, significantly harming operating results and clinical trial conduct[211]. - The manufacturing process for biologics is complex and highly regulated, with higher costs and risks of product loss or failure compared to traditional small molecule compounds[213]. Financial and Operational Risks - The company has a history of operating losses and expects these losses to continue indefinitely, raising substantial doubt about its ability to continue as a going concern[170]. - The company has no approved products or product candidates pending approval, resulting in no revenue from product sales and a reliance on raising additional financing[171]. - The company anticipates that operational costs will increase significantly, with cash and cash equivalents expected to fund operations only through Q4 2026 without additional grants[172]. - Plans to raise additional capital through common share issuance and grants are uncertain, and failure to secure this funding may lead to curtailed operations[173]. - The biotechnology industry is characterized by rapid technological developments and high competition, which may hinder the company's ability to compete effectively[170]. - The company faces risks related to compliance with various federal and state laws, which could result in significant penalties if violated[150]. - Significant uncertainty exists regarding the coverage and reimbursement status of pharmaceutical products, which can vary significantly among third-party payors[151]. - The U.S. government and foreign jurisdictions are implementing cost-containment programs that may limit sales of pharmaceutical products[153]. - The Affordable Care Act (ACA) has significantly affected the pharmaceutical industry, with ongoing legislative challenges and reforms impacting pricing and reimbursement[157]. Regulatory Environment - The FDA regulates the research, development, and marketing of biologics, requiring compliance with various preclinical and clinical approval processes[121]. - Human clinical trials typically involve three phases, with Phase 1 focusing on safety, Phase 2 on preliminary efficacy, and Phase 3 on establishing risk/benefit ratios[127]. - The BLA submission to the FDA must include all relevant data from preclinical and clinical studies, along with a substantial application user fee[128]. - The FDA aims to review standard BLA applications within ten months and priority reviews within six months after acceptance for filing[129]. - Approval letters authorize commercial marketing with specific indications, while Complete Response letters outline deficiencies and may delay approval[130]. - Orphan drug designation is granted for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S., providing seven years of exclusivity upon first approval[138][139]. - The FDA may require post-marketing studies to monitor safety and effectiveness, and can withdraw approval if compliance is not maintained[141][142]. - Fast track designation and breakthrough therapy designation expedite the review process for products addressing serious conditions with unmet medical needs[132][133]. - Products may receive accelerated approval based on surrogate endpoints likely to predict clinical benefit, with post-marketing studies required[135]. - The BPCIA establishes a 12-year exclusivity period for reference products, impacting the approval timeline for biosimilars[146]. - The FDA's regulations impose strict requirements on record-keeping, adverse experience reporting, and compliance with cGMP for approved products[141]. - The FDA may impose restrictions or withdraw approval based on newly discovered safety issues or non-compliance with regulatory standards[142][143]. Intellectual Property and Strategic Alliances - The company’s commercial success depends on obtaining and maintaining patent protection for its technology and inventions, as well as defending proprietary rights[107]. - The intellectual property portfolio includes patent applications for methods of generating multi-antigen specific T cell products and their therapeutic uses[108]. - The company believes its patent portfolio and next-generation technologies provide a substantial intellectual property position, though the biotechnology patent landscape is evolving with risks[109]. - The company reassesses the value of each patent at maintenance fee due dates, declining to pay for patents deemed of no significant strategic value[111]. - The company relies on trade secrets and regulatory protections, including orphan drug designations and market exclusivity, to maintain its proprietary position in immuno-oncology[117]. - The company entered into a Statement of Work with Cellipont for the manufacturing of MT-601, its lead MAR-T cell product, in anticipation of a pivotal trial for lymphoma in 2026[82]. - The company has entered into a strategic alliance with BCM for advancing pre-clinical and early-stage clinical trials, ensuring continued access to clinical data and manufacturing support[103]. - The BCM License Agreement includes a royalty fee schedule based on net sales, with percentages ranging from 0.65% to 5.0%[96]. - The company is responsible for up to $64.85 million in milestone payments upon achieving specific clinical and sales milestones under the BCM License Agreement[96]. - The company retains ownership over any intellectual property developed under CPRIT grant agreements, granting CPRIT a nonexclusive, irrevocable, royalty-free license for non-commercial use[105]. - If products become commercially saleable, the company is obligated to pay CPRIT a percentage of revenue ranging from low-to-mid single digits until CPRIT receives an aggregate amount of 400% of the funds paid under the grant agreements[106]. Workforce and Corporate Structure - The company has 5 full-time employees as of December 31, 2025, with no employees under collective bargaining agreements[162]. - 100% of the company's executive officers are women or self-identify as members of underrepresented minority groups[165]. - The company is incorporated in Delaware and trades on the Nasdaq Capital Market under the symbol "MRKR"[166]. - The company has not experienced any product liability claims to date but carries products and clinical trial liability insurance policies[161]. - The company has consulting agreements with leading academic scientists and regulatory experts to support its operations[163]. - The company’s human capital resources objectives include attracting and retaining a diverse workforce[165].

Marker Therapeutics (NasdaqCM:MRKR) FY Conference February 25, 2026 08:00 AM ET Company ParticipantsAnthony - AssociateJuan Vera - President and CEOAnthonyGood morning, everyone, and thanks so much for joining us. I'm Anthony, an associate here at Oppenheimer, and it is my pleasure to introduce Marker Therapeutics. Marker is an immuno-oncology company focused on developing T-cell therapies using its multi-antigen recognizing or MAR-T platform. The lead program is MT-601, and it's being studied in relapse ly ...

HOUSTON, Feb. 18, 2026 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that its Chief Executive Officer, Dr. Juan Vera, will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference, being held in a virtual format on February 25-26, 2026. Presentation Details: Event:Oppenheime ...

Core Insights - Marker Therapeutics, Inc. announced that Baylor College of Medicine's TACTOPS clinical study in pancreatic cancer was featured on Good Morning America, highlighting the need for innovative approaches in treating one of the deadliest forms of cancer [1][2] Group 1: Clinical Study Highlights - The Baylor-led research published in Nature Medicine evaluated autologous Multi-Antigen Targeted T cell therapy in patients with pancreatic ductal adenocarcinoma (PDAC), addressing a significant unmet need in pancreatic cancer [2] - The Phase 1/2 pancreatic cancer study demonstrated a favorable safety profile with an 84.6% disease control rate when combining Multi-Antigen Targeted T cells with frontline chemotherapy, and a median overall survival of 14.1 months [3] - Infused T cells were detected up to 12 months post-treatment, with higher frequencies observed in patients who responded positively [3] Group 2: Future Developments - Marker Therapeutics plans to initiate a Company-sponsored study to potentially improve upon the Baylor study results by increasing the target antigen profile and using higher cell doses [4] - The upcoming pancreatic cancer program is expected to begin in the first half of 2026, supported by funding from the NIH Small Business Innovation Research program and the Cancer Prevention and Research Institute of Texas [4] Group 3: Technology Overview - The MAR-T cell platform is a novel, non-genetically modified cell therapy that selectively expands tumor-specific T cells capable of recognizing a broad range of tumor antigens, reducing the possibility of tumor escape [5] - The lead product, MT-601, targets six different tumor antigens and is currently being investigated in the Phase 1 APOLLO trial for lymphoma, with potential applications in pancreatic cancer [6][8]

Core Insights - Marker Therapeutics' shares have increased by approximately 114% over the past three months, primarily due to positive momentum surrounding its lead candidate, MT-601, which has enhanced investor confidence [1][7] Clinical Development - The phase I APOLLO study for MT-601 has shown promising results, with about 66% of patients with Non-Hodgkin Lymphoma achieving an objective response and 50% achieving a complete response [2][3] - The responses in the APOLLO study were durable, lasting from three to 24 months, with some patients maintaining benefits beyond six months, including responses extending over one year [2] - MT-601 also demonstrated a 78% response rate in patients with Hodgkin Lymphoma, leading the company to advance to the dose expansion phase for patients with relapsed diffuse large B cell lymphoma [3] Future Prospects - Additional clinical data from the APOLLO study is anticipated in the first half of 2026, which is expected to serve as a significant catalyst for the stock [3] - The company plans to initiate clinical studies for MT-601 targeting pancreatic cancer in the first half of 2026 [6] Financial Position - Marker Therapeutics has secured non-dilutive funding from various institutions, including the National Institutes of Health, to support the development of MT-601 and its Off-the-Shelf (OTS) program [10] - The company raised approximately $10 million through its at-the-market facility, extending its cash runway into 2026 and providing financial stability for ongoing clinical development [11] Manufacturing and Collaboration - Marker Therapeutics has entered into a strategic manufacturing collaboration with Cellipont to enhance the production capabilities of MT-601 [8] Additional Developments - The company has made progress with its OTS platform, having treated its first patient in a phase I RAPID study for MT-401, which was well-tolerated without side effects [9]

Core Viewpoint - MARKER THERAPEUTICS, INC. (MRKR) shows potential as a stock pick due to a recent "golden cross" event, indicating a bullish trend reversal [1][4]. Technical Analysis - A "golden cross" occurs when a stock's short-term moving average (50-day) crosses above its long-term moving average (200-day), signaling a bullish breakout [2]. - The formation of a golden cross involves three stages: a downtrend that bottoms out, the crossover of moving averages, and continued upward momentum [3]. Performance Metrics - MRKR has experienced a 24.8% rally over the past four weeks, suggesting strong upward momentum [4]. - The company currently holds a 1 (Strong Buy) rating on the Zacks Rank, indicating positive market sentiment [4]. Earnings Expectations - There has been one upward revision in earnings expectations for the current quarter, with no downward changes in the past 60 days, further supporting the bullish outlook [4]. - The Zacks Consensus Estimate for MRKR has also increased, reinforcing investor confidence in the stock's potential [4]. Investment Consideration - Given the technical indicators and positive earnings revisions, MRKR should be considered for inclusion on investors' watchlists [5].

Industry Overview - The drug and biotech sector has shown recovery after a sluggish first half, supported by drug pricing agreements with the Trump administration and renewed M&A activity [1][4] - Innovation in areas such as obesity treatments, gene therapy, inflammation, and neuroscience continues to drive growth, despite challenges like pipeline setbacks and regulatory uncertainty [2][3] Market Performance - The Zacks Medical-Drugs industry has underperformed compared to the Zacks Medical sector and the S&P 500 over the past year, with a collective rise of 1.2% compared to 3.4% and 18.9% respectively [13] - The industry currently holds a Zacks Industry Rank of 90, placing it in the top 37% of 244 Zacks industries, indicating potential for outperformance [12] Valuation Metrics - The industry is trading at a trailing 12-month price-to-sales (P/S) ratio of 2.25, lower than the S&P 500's 6.03 and the Zacks Medical sector's 2.61 [16] Key Companies and Their Prospects - **Ironwood Pharmaceuticals**: Developing apraglutide for short bowel syndrome, with a significant rise in stock price by 178.9% in the past three months and a consensus estimate for 2026 earnings increasing from $0.40 to $0.47 [20][22] - **Rigel Pharmaceuticals**: Sales of Tavalisse rose by approximately 54% in the first nine months of 2025, with a stock increase of 46.7% and a consensus estimate for 2026 earnings rising from $3.70 to $4.30 [24][27] - **Soleno Therapeutics**: Launched Vykat XR for Prader-Willi syndrome, generating around $99 million in sales since April, with a stock decline of 25.7% but a rising consensus estimate for 2026 earnings from $3.10 to $3.59 [29][30] - **Marker Therapeutics**: Focused on next-generation T cell therapies, with a stock increase of 75.5% and a narrowing consensus estimate for 2026 loss per share from $4.92 to $1.86 [33][34] - **Nektar Therapeutics**: Developing rezpegaldesleukin for atopic dermatitis and alopecia areata, with a stock decline of 26.0% but a narrowing consensus estimate for 2026 loss per share from $12.17 to $10.81 [36][38]