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]

Key Takeaways MRKR stock rose 114% in three months driven by strong phase I APOLLO data for its lead T-cell therapy MT-601.MT-601 delivered ~66% response in NHL and 78% in Hodgkin Lymphoma with durable responses.MRKR advanced MT-601 to dose expansion, secured funding and manufacturing support & expects more data in 1H26.Marker Therapeutics’ (MRKR) shares have surged approximately 114% over the past three months, driven by strong momentum surrounding its early-stage lead candidate, MT-601, which has boosted ...

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]

Core Insights - Marker Therapeutics, Inc. has reported promising results from a Phase 1/2 clinical study at Baylor College of Medicine, demonstrating a disease control rate of 84.6% in pancreatic cancer patients treated with Multi-Antigen Targeted T cells combined with frontline chemotherapy [2][5]. Group 1: Clinical Study Results - The Phase 1/2 clinical study showed a median duration of response of 7.5 months for patients achieving a partial or complete response, with a median overall survival rate of 14.1 months [2]. - The study indicated a favorable safety profile for Multi-Antigen Targeted T cells when used in combination with chemotherapy, without increasing toxicity [3]. Group 2: Mechanism and Efficacy - The research highlighted a correlation between clinical benefits and the expansion and persistence of infused Multi-Antigen Targeted T cells, which were still present in patients 12 months post-treatment [4]. - Chemotherapy was noted to facilitate T cell infiltration into tumors by breaking down protective stromal cells, enhancing the anti-tumor response [3]. Group 3: Future Developments - Marker Therapeutics plans to enhance the MAR-T cell technology by increasing the number of target antigens and cell doses, and by adding lymphodepletion to support T cell expansion [5]. - The company has secured non-dilutive funding from the NIH and CPRIT to support its pancreatic cancer program, allowing it to advance without affecting its financial runway [6]. Group 4: Product Information - The lead product, MT-601, is a MAR-T cell therapy targeting six tumor antigens and is currently being investigated in the Phase 1 APOLLO trial for lymphoma [9]. - The company aims to explore the application of MT-601 beyond lymphoma to include pancreatic cancer, supported by funding from the National Cancer Institute and CPRIT [9].

Core Insights - Several small-cap biotech and healthcare companies experienced notable gains in after-hours trading, driven by recent corporate updates and clinical milestones Company Updates - Inspira Technologies Oxy B.H.N. Ltd. (IINN) rose 5.88% to $1.08 following a recent definitive agreement for a registered direct offering of its ordinary shares and a Standby Equity Purchase Agreement with YA II PN, Ltd. [2] - Galectin Therapeutics Inc. (GALT) increased by 1.79% to close at $6.27, despite no new corporate developments reported [3] - MediciNova, Inc. (MNOV) advanced 4.83% to $1.52 after successfully completing patient enrollment in its Phase 2 OXTOX study, evaluating MN-166 for chemotherapy-induced peripheral neuropathy in metastatic colorectal cancer patients [4] - Marker Therapeutics, Inc. (MRKR) gained 5.56% to $1.33 without any new company-specific announcements [5] - Sharps Technology, Inc. (STSS) climbed nearly 4% to $2.09, also without fresh updates [6] - DiaMedica Therapeutics Inc. (DMAC) rose 2.89% to $8.55 after a productive pre-IND meeting with the FDA regarding its planned study of DM199 in preeclampsia [6] - Corbus Pharmaceuticals Holdings, Inc. (CRBP) edged higher by 1.36% to $8.21, following the completion of its Phase 1a study of CRB-913 and initiation of the Phase 1b CANYON-1 trial [7] - ProMIS Neurosciences, Inc. (PMN) added 0.83% to $8.49, recovering slightly after a decline earlier in the day, with the completion of enrollment of 144 patients in its PRECISE-AD Phase 1b clinical trial for Alzheimer's disease [8]

Core Points - The article emphasizes the importance of enabling Javascript and cookies in browsers to prevent access issues [1] - It highlights that users with ad-blockers may face restrictions when trying to access content [1] Summary by Categories Technical Requirements - Users are advised to enable Javascript and cookies in their browsers to ensure proper functionality [1] - The presence of ad-blockers can lead to blocked access, necessitating their disabling for content access [1]

Clinical Development - MT-601 achieved a 66% objective response rate and a 50% complete response rate in relapsed Non-Hodgkin lymphoma patients during the APOLLO study[4] - The first patient was treated in the Off-the-Shelf (OTS) program investigating MAR-T cells for Acute Myeloid Leukemia or Myelodysplastic Syndrome[4] - The company anticipates additional clinical data from the APOLLO study in the first half of 2026[8] - Marker was awarded $2.0 million from the NIH and $9.5 million from CPRIT to support the development of MT-601 in metastatic pancreatic cancer[8] Financial Performance - The net loss for Q3 2025 was $2.0 million, an improvement from a net loss of $2.3 million in Q3 2024[11] - For the nine months ended September 30, 2025, the net loss was $10,460,410, compared to a net loss of $6,893,691 for the same period in 2024, indicating an increase in losses of approximately 51%[21] - Net cash used in operating activities for the nine months ended September 30, 2025, was $10,113,975, up from $6,207,189 in 2024, reflecting a 63% increase in cash outflow[21] - Cash, cash equivalents, and restricted cash at the end of the period were $18,942,953, a decrease from $19,192,440 at the beginning of the period[21] - The net decrease in cash, cash equivalents, and restricted cash for the nine months ended September 30, 2025, was $249,487, compared to a much larger decrease of $6,111,786 in 2024[21] Expenses - Research and development expenses for Q3 2025 were $2.3 million, down from $3.5 million in Q3 2024[10] - General and administrative expenses for Q3 2025 were $1 million, compared to $0.9 million in Q3 2024[10] - The company reported stock-based compensation of $426,409 for the nine months ended September 30, 2025, compared to $195,320 in 2024, representing a 118% increase[21] Cash Management - The company raised approximately $10 million through its ATM facility, extending its cash runway into 2026[4] - As of September 30, 2025, Marker had cash and cash equivalents of $17.6 million and restricted cash of $1.4 million, expected to fund operations through Q3 2026[9] - The company raised $9,863,883 from the issuance of common stock during the nine months ended September 30, 2025, compared to $36,902 in 2024, showing a significant increase in financing activities[21] Other Financial Metrics - Deferred revenue increased to $1,352,975 for the nine months ended September 30, 2025, indicating potential future revenue recognition[21] - The company experienced a significant change in accounts payable and accrued expenses, which decreased by $901,449 from the previous year[21] - Proceeds from the exercise of warrants and stock options were $605 for the nine months ended September 30, 2025, down from $58,501 in 2024, indicating a decline in stock option activity[21] - Other receivables increased to $681,550 for the nine months ended September 30, 2025, compared to $283,405 in 2024, reflecting improved collection or new receivables[21] Manufacturing Collaboration - Marker entered a cGMP manufacturing collaboration with Cellipont Bioservices to scale up production of MT-601[2]

Core Insights - Marker Therapeutics reported promising results from the Phase 1 APOLLO study, showing a 66% objective response rate and 50% complete response rate in relapsed Non-Hodgkin lymphoma patients, indicating the potential of MT-601 as a treatment option for patients with limited therapy options [2][5] - The company has initiated its Off-the-Shelf program, treating the first patient in the RAPID study, which focuses on MAR-T cells for Acute Myeloid Leukemia and Myelodysplastic Syndrome [2][12] - A strategic manufacturing collaboration with Cellipont Bioservices has been established to enhance the production capabilities of MT-601, supporting clinical supply and future pivotal trials [2][12] Clinical Updates - The APOLLO study demonstrated durable responses, with five patients maintaining responses for at least six months, and three for over twelve months [5] - No dose-limiting toxicities or immune effector cell-associated neurotoxicity were observed, highlighting a favorable safety profile for MT-601 [5] - The ongoing dose expansion cohort is evaluating MT-601 at the highest dose level in patients with Diffuse Large B Cell Lymphoma who have relapsed or are ineligible for CAR-T therapy [5] Financial Highlights - As of September 30, 2025, Marker Therapeutics had cash and cash equivalents of $17.6 million and restricted cash of $1.4 million, which is expected to fund operations through the third quarter of 2026 [8] - Research and development expenses for Q3 2025 were $2.3 million, a decrease from $3.5 million in Q3 2024, while general and administrative expenses increased slightly to $1 million from $0.9 million [9] - The company reported a net loss of $2.0 million for Q3 2025, compared to a net loss of $2.3 million in the same quarter of the previous year [10] Corporate Developments - Marker Therapeutics raised approximately $10 million through its ATM facility, extending its cash runway into 2026 [2][12] - The company has received non-dilutive funding from NIH and CPRIT to support the development of MT-601 in metastatic pancreatic cancer, with a clinical program launch anticipated in the first half of 2026 [5][12] - The appointment of Kathryn Penkus Corzo to the Board of Directors was announced, effective November 1, 2025 [12]

Financial Performance - Total revenues for the three months ended September 30, 2025, were $1,233,000, a decrease of 36% compared to $1,926,000 in the same period of 2024[122]. - Total revenues for the nine months ended September 30, 2025 were $2.4 million, a decrease of 44% from $4.3 million in 2024[139]. - The net loss for the nine months ended September 30, 2025 was $10.5 million, an increase of 52% from a net loss of $6.9 million in 2024[139]. Research and Development - Research and development expenses decreased by 32% to $2,346,000 for the three months ended September 30, 2025, compared to $3,471,000 in 2024[122]. - Research and development expenses increased by 15% to $9.7 million for the nine months ended September 30, 2025, compared to $8.4 million in 2024[152]. - The company has a pipeline that includes two product candidates for three clinical indications as part of the MAR-T cell program[105]. Clinical Trials and Studies - Eight out of 12 Non-Hodgkin Lymphoma (NHL) patients achieved objective responses (66%) in the Phase 1 APOLLO study, with 50% demonstrating complete response (CR)[111]. - The company reported no treatment-related side effects in the APOLLO study, indicating a favorable safety profile for the MAR-T cell therapy[110]. - The company entered into a Statement of Work with Cellipont Bioservices for the manufacturing of MT-601, supporting the scale-up for the APOLLO study[114]. Grants and Funding - The company received a $2.0 million grant from the NIH SBIR program in August 2024 to support MT-601 for pancreatic cancer, recognizing approximately $0.2 million in revenue for the nine months ended September 30, 2025[129]. - An additional $9.5 million grant from CPRIT was awarded in December 2024 for MT-601 in metastatic pancreatic cancer, with $1.4 million recorded as restricted cash and deferred revenue as of September 30, 2025[130]. - The Company received a total of $2.0 million in grants from the NIH SBIR program to support the development of MT-401 for AML patients, with $1.5 million received to date[170]. Operating Expenses - Operating expenses for the three months ended September 30, 2025 were $3.4 million, a decrease of 21% from $4.3 million in the same period in 2024[131]. - Operating expenses for the three and nine months ended September 30, 2025, were $3.4 million and $13.4 million, respectively, compared to $4.3 million and $11.6 million in the prior year periods[177]. - General and administrative expenses increased by 20% to $1.0 million for the three months ended September 30, 2025, primarily due to headcount-related expenses[135]. Stock and Capital - The company sold 1,624,075 shares of common stock for net proceeds of $4.5 million at an average price of $2.87 per share between July 17 and 21, 2025[119]. - An additional 3,734,217 shares were sold for net proceeds of $5.4 million at an average price of $1.48 per share on August 26, 2025[176]. - The Company plans to continue funding operations through equity and/or debt financing, which may dilute existing stockholders' interests[179]. Future Outlook - The company anticipates continued net losses as it invests in research and development activities, including clinical development of MAR-T cell product candidates[138]. - The company expects to fund its operating expenses through the third quarter of 2026, assuming no additional grant funds are received[159]. - High inflation and economic recession concerns may negatively affect the Company's liquidity and ability to access capital[180].