Nogapendekin alfa inbakicept-pmln

Issued on behalf of GT Biopharma, Inc. (NASDAQ: GTBP) Three drugs in human trials. A platform licensed from one of the world's top cancer-research universities. A market cap smaller than a Manhattan apartment. For investors willing to look where almost no one is looking, GT Biopharma is the kind of asymmetric setup that biotech is built on. NEW YORK, May 29, 2026 /PRNewswire/ -- USA News Group Market Commentary - Start with the number that makes everyone do a double take. As of mid-May 2026, GT Biopharma (NASDAQ: GTBP) carried a market capitalization of roughly $13 million. Thirteen million. That is not a typo, and it is not a shell company. It is a clinical-stage immuno-oncology company with three separate drug candidates already dosing patients in human trials, a technology platform exclusively licensed from the University of Minnesota, and a scientific approach that the largest names in cancer immunotherapy are spending billions to pursue. See the full GT Biopharma investor breakdown at USA News Group → That gap — between what the company is doing in the clinic and what the market is paying for it — is the entire story. Whether it closes, and in which direction, is the question every investor reading this should be weighing right now. The idea: don't build a new weapon, sharpen the one you already have Most cancer therapies try to bolt something new onto the body — a manufactured cell, a synthetic antibody, a toxic payload. GT Biopharma's approach is different, and once you understand it, it's hard to forget. The human immune system already contains a class of cells whose entire job is to find and destroy abnormal cells: natural killer cells, or NK cells. They are the immune system's first responders, patrolling the body and killing threats without needing to be "trained" first. The problem in cancer is that tumors learn to hide from them. GT Biopharma's platform, called TriKE® — short for Tri-specific Killer Engager — is designed to drag those NK cells directly onto the tumor and switch them on. A TriKE molecule is engineered with three parts joined together. One arm grabs the NK cell by a receptor called CD16. A second arm grabs the cancer cell by a marker on its surface. And in the middle sits a molecule called IL-15, which acts like a shot of adrenaline, keeping the NK cell alive and multiplying once it's locked onto its target. The result, in concept, is elegant: you take the body's existing assassins, handcuff them to the tumor, and tell them to get to work. The platform was developed at the University of Minnesota, and GT Biopharma holds an exclusive worldwide license to develop and commercialize therapies based on it. This is not a science project the company dreamed up in isolation — it's institutional research that GTBP has the rights to turn into medicine. Why now: three shots on goal, all live What changed in 2026 is that GT Biopharma stopped being a one-drug story. As of this spring, the company has advanced three TriKE candidates into the clinic — a milestone its leadership rightly calls a turning point. Track every clinical milestone on the GTBP catalyst timeline → The lead program is GTB-3650, aimed at relapsed or refractory CD33-positive blood cancers — specifically acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS), two of the most treatment-resistant cancers in oncology. It is the first TriKE built on camelid nanobody technology — antibody fragments derived from the same family as llamas and alpacas, prized for being small, stable, and able to penetrate tissue. The Phase 1 dose-escalation trial began enrolling in early 2025 and has moved methodically upward through its dose cohorts. As of the company's Q1 2026 report in May, Cohort 4 enrollment was complete with eight patients treated across the first four cohorts — and, critically, the earlier safety reviews advanced without the dose-limiting toxicities that derail so many early trials. The study can escalate through up to seven cohorts, and management has guided to a meaningful data update in the second half of 2026. The newest program is where the ambition becomes obvious. In May 2026, GT Biopharma dosed the first patient in the Phase 1 trial of GTB-5550, a TriKE targeting a protein called B7-H3. Here is why that matters: B7-H3 is expressed on a huge range of solid tumors, and in metastatic castration-resistant prostate cancer it appears in over 90% of tumors. The trial begins with a prostate-cancer-focused dose escalation, then expands into a "basket" across as many as seven solid tumor types — prostate, ovarian, breast, head and neck, non-small cell lung, pancreatic, and bladder. In the company's own framing, the solid-tumor patient population GTB-5550 targets is "orders of magnitude larger" than the blood-cancer population of its lead drug. And GTB-5550 uses subcutaneous dosing — a simple injection rather than an infusion — which the company describes as more patient-friendly, a quiet but real commercial advantage if the drug works. Three programs. Two cancers as different as liquid and solid tumors. One underlying platform. That is the shape of a company trying to prove a technology, not just a single molecule. The market it's chasing is enormous The backdrop here is not subtle. The global oncology market is projected to nearly double from roughly $139 billion in 2025 to about $268 billion by 2034. Solid tumors alone represent a market estimated in the hundreds of billions of dollars, and B7-H3 — GTB-5550's target — shows up across many of the most common and lethal of them. NK-cell-directed immunotherapy has become one of the most closely watched frontiers in the entire sector, precisely because it offers the prospect of harnessing the immune system with potentially fewer of the brutal side effects of conventional treatment. Why NK-cell therapy is biotech's hottest frontier — read the deep dive → When a tiny company is pointed at a market that large, the math of asymmetry takes over. It does not require GT Biopharma to win the whole field. It requires only that one of its three shots connects — and that the market eventually notices a company priced near $13 million is playing in an arena measured in the hundreds of billions. How GT Biopharma stacks up against its NK-cell peers The most useful way to understand GTBP's positioning is to look at the company it keeps. NK-cell and immune-engager therapy is a crowded, well-funded field — and the contrast in scale is the entire investment argument. ImmunityBio (NASDAQ: IBRX) is the proof of concept that NK-cell immunotherapy can reach the market. Its NK-activating therapy ANKTIVA is FDA-approved for bladder cancer, the company reported roughly $44 million in product revenue in Q1 2026 and held some $381 million in cash, and it is now scaling NK-cell manufacturing to billions of cells per batch. ImmunityBio is what NK-cell success looks like at commercial scale — and a reminder of the valuation gap a clinical-stage peer could theoretically narrow if its data delivers. Fate Therapeutics (NASDAQ: FATE) is the deep-pocketed platform play, engineering off-the-shelf NK and CAR-T cell therapies from induced pluripotent stem cells, with roughly $175 million in cash and a runway management has guided into 2028. Fate illustrates how richly the market will fund an NK/cell-therapy platform it believes in — a striking counterpoint to GTBP's microcap valuation. Nkarta (NASDAQ: NKTX) is the engineered-NK-cell specialist, advancing its platform into autoimmune disease and backed by a market capitalization and cash position orders of magnitude above GT Biopharma's. Nkarta shows that NK-cell companies can command substantial valuations well before commercialization, on the strength of platform potential alone. Artiva Biotherapeutics (NASDAQ: ARTV) rounds out the set as the allogeneic, off-the-shelf NK-cell developer whose lead candidate AlloNK is heading toward a Phase 3 registrational trial in refractory rheumatoid arthritis in 2026. Artiva demonstrates how far and how fast an NK-cell program can advance through the clinic — the kind of trajectory GTBP investors are betting its TriKE platform can follow. Set GT Biopharma beside those four names and the picture sharpens. They are pursuing variations of the same fundamental thesis — unleash NK cells against disease — and the market has assigned them valuations ranging from the hundreds of millions into the billions. GT Biopharma, with three candidates already in the clinic, sits near $13 million. Either the market has correctly priced a struggling microcap, or it has badly overlooked a platform company in the same arena as far larger peers. That is the bet, stated plainly. The risks, stated honestly No serious investor case is complete without the other side of the ledger, and GT Biopharma's is real. This is a clinical-stage company with no approved products and no product revenue. Its cash balance was approximately $9 million at the end of Q1 2026, which management expects to fund operations only through the fourth quarter of 2026 — meaning additional financing, likely dilutive to existing shareholders, is a near-certainty rather than a possibility. The stock trades well under a dollar and far below its 52-week high, and a Roth Capital analyst, while maintaining a Buy rating, cut the price target to $3 from $8 earlier this year. Phase 1 trials are designed to test safety, not to prove a drug works; the encouraging absence of dose-limiting toxicities and the early signs of NK-cell activation are genuinely positive, but they are not efficacy. Most drugs that enter Phase 1 never reach the market. And the very peers that make GTBP look cheap are also formidable competitors with vastly greater resources. In short: this is a high-risk, binary-outcome situation. It is exactly the kind of company that can multiply many times over on a single strong data readout — and exactly the kind that can be forced into painful dilution or worse if the data disappoints or the financing window closes. Both outcomes are live. The bottom line GT Biopharma is a study in asymmetry. On one side: a roughly $13 million valuation, a sub-dollar stock, a thin cash runway, and all the risk that comes with clinical-stage biotech. On the other: three drugs dosing patients, a platform licensed from a top-tier research university, a mechanism the biggest players in immuno-oncology are validating with their own R&D budgets, and a pair of catalysts — GTB-3650 data and GTB-5550 progress — both expected in the second half of 2026. That is the setup. A company priced for failure, sitting on a platform built for something much larger, with hard data events on the calendar in a matter of months. For investors who understand that the biggest biotech returns come from the names the market has written off just before it's forced to reconsider, GT Biopharma is a story worth watching very closely between now and year-end. Get the full GTBP investor profile, pipeline, and catalyst calendar at USA News Group → CONTACT: USA News Group [email protected] 604-265-2873 Sources: GT Biopharma, Inc., "GT Biopharma Announces First Patient Dosed in Phase 1 Trial of GTB-5550, a B7-H3-Targeted Natural Killer (NK) Cell Engager for Solid Tumors," GlobeNewswire, May 14, 2026. GT Biopharma, Inc., "GT Biopharma Reports First Quarter 2026 Financial Results," May 15, 2026 (Cohort 4 complete, 8 patients across first four cohorts; ~$9M cash to Q4 2026; 2H 2026 updates). GT Biopharma, Inc., IND submission / pipeline overview — TriKE mechanism (camelid anti-CD16 / scFv anti-CD33 / IL-15), GTB-3650 dose-escalation design (up to 7 cohorts, ~14 patients), GTB-5550 design and B7-H3 >90% in mCRPC; gtbiopharma.com product pipeline. Roth Capital analyst note (Jonathan Aschoff), price target revised to $3 (Buy), 2026. Global Market Insights Inc. oncology market size ($139.4B 2025 → $268.3B 2034); Data Bridge Market Research solid-tumor market context. ImmunityBio (NASDAQ: IBRX) Q1 2026 results and NK-cell manufacturing release, 2026. Fate Therapeutics (NASDAQ: FATE) Q1 2026 results (runway into 2028), May 13, 2026. Nkarta (NASDAQ: NKTX) corporate/clinical disclosure, 2026. Artiva Biotherapeutics (NASDAQ: ARTV) corporate disclosure / AlloNK Phase 3 plan, 2026. DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a digital media distribution and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). This article is being distributed by USA News Group on behalf of MIQ. MIQ has been paid a fee for GT Biopharma, Inc. advertising and digital media from Creative Direct Marketing Group ("CDMG"). There may be 3rd parties who may have shares of GT Biopharma, Inc. and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this article or email as the basis for any investment decision. The owner/operator of MIQ currently owns shares of GT Biopharma, Inc. that were purchased in the open market and reserves the right to buy and sell, and will buy and sell shares of GT Biopharma, Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company; no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been reviewed and approved on behalf of GT Biopharma, Inc. by CDMG; this is a digital media distribution. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our article is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. Logo: SOURCE USA News Group 21% more press release views with Request a Demo

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced new survey data highlighting the diverse treatment preferences and decision-making priorities of patients with Bacillus Calmette–Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC). The findings were presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2026, May 17–20, 2026, at the Pennsylvania Convention Center in Philadelphia, Pennsylvania. The mixed-methods study, conducted in partnership with Fight Bladder Cancer, a UK-based patient advocacy organization, explored how patients with NMIBC who were currently receiving or had previously received BCG weigh radical cystectomy against bladder-sparing therapies following BCG treatment failure. The study provides a contemporary, patient-centered perspective on the factors influencing treatment decision-making in this setting. “Treatment decisions for patients with BCG-unresponsive NMIBC are deeply personal and often complex,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “These findings reinforce the importance of incorporating patient perspectives, quality-of-life considerations, and individual treatment priorities into shared decision-making conversations.” The study used an online questionnaire completed by 86 UK adults living with NMIBC who were currently receiving or had previously been treated with BCG. This survey data was supplemented by one-on-one interviews and focus group discussions. Together, these methods were designed to evaluate treatment experiences, priorities, and trade-off preferences related to bladder-sparing approaches versus radical cystectomy following BCG failure. The data showed that treatment preferences among UK patients with NMIBC are highly individualized, shaped by past treatment experiences, personal values, and age. Key findings include: Patients actively receiving BCG were more likely to favor bladder preservation strategies Patients who had previously undergone radical cystectomy were more likely to support repeating that decision Older participants demonstrated a lower preference for radical cystectomy Clinical effectiveness, including impact on recurrence, progression, and life expectancy, was identified as the most important factor influencing treatment decisions Lifestyle disruption and quality-of-life considerations varied across patients, with male participants expressing greater concern regarding the daily-life impact of radical cystectomy The authors concluded that UK adults living with NMIBC have widely varying treatment priorities—some placing greater weight on cancer control and life expectancy, while others prioritize quality of life and bladder preservation—with many willing to accept trade-offs, such as more frequent hospital visits, to avoid radical cystectomy. Taken together, the findings underscore that there is no one-size-fits-all approach to treatment decisions in this population, and highlight the importance of individualized, patient-centered care. About Fight Bladder Cancer UK Fight Bladder Cancer is the only patient-led bladder cancer charity in the United Kingdom. The charity is dedicated to supporting people affected by bladder cancer, raising awareness, and funding research to improve diagnosis and treatment. It provides support and mentorship for those impacted by the disease, and creates resources for patients, caregivers, and healthcare professionals. It also advocates for better care and policy change. For more information, visit https://www.fbc.uk.com/ About ImmunityBio ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding: the potential implications of patient preference data on treatment decision-making and shared care conversations in BCG-unresponsive NMIBC; the potential for bladder-sparing therapies to address unmet needs in patients with high-risk NMIBC; the continued development and commercialization of ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with BCG for BCG-unresponsive NMIBC; the potential for patient-centered evidence to inform healthcare policy, reimbursement decisions, and clinical practice guidelines; future research collaborations and partnerships with patient advocacy organizations; and the potential expansion of indications or patient populations for ImmunityBio's product candidates. These forward-looking statements are based on ImmunityBio's current expectations, estimates, forecasts, and projections and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Such risks and uncertainties include, but are not limited to: the inherent limitations of survey and qualitative research methodologies; the potential that patient preferences may not translate into clinical practice changes or commercial adoption; risks related to the clinical development, regulatory approval, and commercialization of ANKTIVA, including the ability to demonstrate safety, efficacy, and durability of response; the timing and results of ongoing and future clinical trials; uncertainties regarding regulatory submissions and the ability to obtain and maintain regulatory approvals; manufacturing and supply constraints, including BCG availability; competition from other therapies and treatment approaches; market acceptance and reimbursement of approved products; general economic and market conditions; and other risks described under the heading "Risk Factors" in ImmunityBio's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on May 7, 2026, and in subsequent filings made with the SEC. ImmunityBio cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. ImmunityBio undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as may be required by applicable law.