Tovecimig

Issued on behalf of GT Biopharma, Inc. GT Biopharma, Inc. (NASDAQ: GTBP) says newly implemented AI-based tools are accelerating its drug discovery and engineering, with multiple new development candidates expected to move into pre-IND development in 2027 and potential indications expanding beyond oncology. USA News Group News Commentary NEW YORK, June 30, 2026 /PRNewswire/ -- Drug discovery has long been a slow, expensive process of trial and error, and for a small clinical-stage company, every wasted experiment is capital it can scarcely afford. That is the backdrop for a recent update from GT Biopharma, Inc. (NASDAQ: GTBP), a clinical-stage immuno-oncology company built around its proprietary natural killer (NK) cell engager platform. On June 1, 2026, the company said it has implemented artificial-intelligence-based tools across its discovery and protein-engineering work, and that the resulting efficiency gains are expected to push multiple new development candidates into pre-IND development in 2027. Key Takeaways GT Biopharma (NASDAQ: GTBP) reported increased integration of AI-based tools across the discovery and engineering of its tumor-targeting NK cell engagers and multi-domain proteins, aiming to accelerate development while reducing cost. The company says the approach reduces reliance on trial-and-error experimentation, shortens timelines, and increases the likelihood that candidates show robust binding and functional activity before advancing. GT Biopharma anticipates multiple new development candidates entering pre-IND development in 2027, with potential targets and indications expanding beyond oncology. The update arrives as its clinical programs advance: GTB-3650 (Phase 1, CD33-expressing blood cancers) and GTB-5550 (Phase 1, B7-H3-expressing solid tumors), with the first GTB-5550 patient dosed in May 2026. Other publicly traded names across NK-cell, immune-engager, and AI-discovery approaches include Nkarta (NASDAQ: NKTX), Fate Therapeutics (NASDAQ: FATE), Compass Therapeutics (NASDAQ: CMPX), and Recursion (NASDAQ: RXRX), each distinct, and none a proxy for GT Biopharma. Putting AI to Work on the Hardest Part of Drug Design The core of the announcement is that GT Biopharma is using AI not as a marketing veneer but at the bench, in the actual design of its molecules. According to the company, AI-guided sequence and structural analyses are used to identify new candidate tumor-targeting engagers and multi-domain proteins with favorable binding, stability, and developability profiles, allowing the team to prioritize early on the molecules most likely to succeed beyond the discovery stage. In a field where the overwhelming majority of early candidates fail, screening computationally before committing lab resources is where time and money are saved. The company describes the tools doing more than just screening. They are also used to inform rational engineering, optimizing the orientation of protein domains, the design of the linkers that connect them, and the overall spatial architecture of a molecule, with the goals of enhancing binding, supporting productive immune-synapse formation, and minimizing structural liabilities that can hurt potency, manufacturability, or consistency. In downstream work, AI-based structural modeling is applied to predict surface exposure, steric compatibility, and assay performance, helping refine constructs before resource-intensive laboratory and animal studies. The throughline is the same: do more of the hard thinking in silico, so that the expensive, slow physical experiments are reserved for the most promising designs. What GT Biopharma Actually Builds: the TriKE Platform To understand why this matters for GT Biopharma specifically, it helps to know what the company makes. GT Biopharma is a clinical-stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on its proprietary TriKE® NK cell engager platform. As the company describes it, the TriKE® platform is designed to harness and enhance the cancer-killing abilities of a patient's immune system's natural killer cells. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology. Designing these multi-domain proteins is exactly the kind of complex, multi-variable engineering problem where computational tools can have an outsized effect. Each TriKE has to bind the right targets with the right strength, fold and remain stable, manufacture consistently, and form a functional connection between immune cell and tumor. Optimizing all of those properties at once, by hand and by trial and error, is painstaking. That is the work GT Biopharma now says it is accelerating with AI. A Bridge to the Clinical Story The discovery update does not exist in isolation. It comes as GT Biopharma advances two TriKE candidates through Phase 1 clinical trials. GTB-3650 is being evaluated in patients with relapsed or refractory CD33-expressing hematologic malignancies, including refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. GTB-5550, which targets the protein B7-H3 on solid tumors, received FDA clearance of its investigational new drug application earlier in 2026, and the company announced that its first patient was dosed in the Phase 1 dose-escalation basket trial in May 2026. Executive Chairman and CEO Michael Breen tied the two threads together, stating that as the company continues "to demonstrate clinical execution acumen with GTB-3650 and GTB-5550 advancing through Phase 1 this year, we are now looking forward to our next-generation assets with potential for shorter development timeliness, increased probability of clinical success, and lower development costs in the coming years." Breen also characterized the shift in plain terms, saying the company has "seen a marked acceleration in our discovery productivity following recent initiatives implementing AI-based technologies, which have been adapted to improve our drug engineering capabilities." In other words, the message to investors is that the same company executing in the clinic today is simultaneously trying to build a deeper, cheaper, faster-moving pipeline behind those lead programs. The Honest Risk Picture None of this removes the substantial risks that come with a micro-cap, clinical-stage biotech, and GT Biopharma is candid about them in its own disclosures. Pre-IND candidates targeted for 2027 are early, and AI-assisted design does not guarantee a molecule will prove safe or effective in humans. The company's forward-looking statements explicitly flag its ability to continue as a going concern, its need for additional capital, the possibility of clinical-trial delays, the risk that products fail to meet safety or efficacy endpoints, and the risk that its common stock could be delisted if it cannot maintain listing requirements. As of its first-quarter 2026 report, the company described a cash position in the single-digit millions, sufficient by its own account to fund operations into the latter part of the year. That financing reality is the central caveat for any investor, and it is characteristic of the high-risk, binary nature of early-stage drug development, where most candidates that enter trials never reach approval. The Public Companies Around the Theme GT Biopharma sits within a broader field of companies pursuing NK-cell, immune-engager, and AI-driven approaches to drug development. These names are referenced for context only; each pursues a different strategy, sits at a different stage, several are far larger and better capitalized, and none is a proxy for GT Biopharma or implies any partnership or comparable outcome. Nkarta (NASDAQ: NKTX) is a dedicated NK-cell therapy developer that has increasingly oriented its engineered NK candidates toward autoimmune disease as well as cancer, underscoring the same "beyond oncology" potential GT Biopharma references. Fate Therapeutics (NASDAQ: FATE) is among the more established NK and induced-pluripotent-stem-cell platform companies, representing the better-resourced end of the cell-therapy spectrum. Compass Therapeutics (NASDAQ: CMPX) offers a window into the broader bispecific and immune-engager landscape, developing antibody-based therapeutics that direct immune activity against tumors; while its modalities differ from TriKE, it belongs to the same conceptual family of engager formats and recently reported a stronger balance sheet and late-stage data progress. Recursion (NASDAQ: RXRX) approaches the theme from the AI angle that GT Biopharma's update highlights, pairing large proprietary datasets and machine learning with drug discovery and major pharmaceutical partnerships, while remaining clinical-stage and pre-profit. Together these names illustrate two powerful currents, NK-directed immunotherapy and AI-enabled drug design, converging on the same goal of better, faster, cheaper medicines, even as each company's fate rests on its own science and execution. The Bottom Line GT Biopharma's AI update is not a clinical result, and it should not be mistaken for one. What it represents is a strategic bet that the company can use modern computational tools to build its next wave of candidates faster and at lower cost, behind two clinical programs already moving through Phase 1. For a capital-constrained micro-cap, efficiency in discovery is not a luxury but a survival strategy, and the promise of pre-IND candidates in 2027 gives investors a concrete future marker to track. Whether the AI-driven approach translates into better molecules and, ultimately, successful therapies remains to be proven in the lab and the clinic. For now, the markers worth watching are the continued progress of GTB-3650 and GTB-5550 through Phase 1, the company's financing path, and the first evidence that its AI-designed candidates can advance as promised. More detail is available in the company's June 1, 2026 announcement. SIGNAL OVER NOISE Signal over noise. Biotech, immuno-oncology, and AI-drug-discovery headlines move fast, and the crowd often moves first. Eagle Eye is a real-time investor signal-intelligence platform that surfaces sentiment shifts, news flow, and trending tickers as they happen, so you see the move forming instead of reading about it later. See it at eagle-eye.dev. CONTACT USA News Group [email protected] SOURCES [1] GT Biopharma, Inc. (NASDAQ: GTBP), "GT Biopharma Provides Update on Pipeline Discovery Activities from Newly Implemented AI-Based Technological Initiatives" (GlobeNewswire, June 1, 2026). Available at: . [2] GT Biopharma, Inc., "GT Biopharma Reports First Quarter 2026 Financial Results" (May 15, 2026; cash position, GTB-3650 Cohort 4, pipeline updates). [3] GT Biopharma, Inc., "First Patient Dosed in Phase 1 Trial of GTB-5550" (May 14, 2026) and "FDA Clearance of IND for GTB-5550" (February 3, 2026). [4] Nkarta, Inc. (NASDAQ: NKTX), Q1 2026 results and corporate highlights (engineered NK therapies; autoimmune focus), May 12, 2026. [5] Fate Therapeutics, Inc. (NASDAQ: FATE), corporate and pipeline disclosures, 2026. [6] Compass Therapeutics, Inc. (NASDAQ: CMPX), Q1 2026 results (~US$209M cash; tovecimig Phase 2/3 data), May 5, 2026. [7] Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX), corporate and AI-platform disclosures, 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. USA News Group is a wholly-owned subsidiary of Market IQ Media Group Limited, accompany incorporated under the laws of Ireland ("MIQL"). This article is being distributed by ISA News Group on behalf of MIQL. MIQL has been paid a fee for GT Biopharma, Inc. advertising and digital media from Creative Direct Marketing Group ("CDMG"). 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. MIQL does not own shares of GT Biopharma, Inc. but reserves the right to buy and sell shares of GT Biopharma, Inc. at any time without any further notice. 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. 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 publication is not trustworthy unless verified by their own independent research. Comparisons to other companies referenced in this publication are for contextual and illustrative purposes only and do not imply any partnership, endorsement, affiliation, or comparable financial performance. Forward-looking statements regarding exploration, development, clinical, regulatory, production, and market outcomes are subject to risks and uncertainties, and actual results may differ materially. 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. FORWARD-LOOKING STATEMENTS: This publication contains forward-looking statements, including statements regarding the expected benefits of GT Biopharma's AI-based discovery and engineering initiatives; the anticipation of multiple new development candidates entering pre-IND development in 2027; the potential expansion of targets and indications beyond oncology; the progress, timing and results of the GTB-3650 and GTB-5550 Phase 1 clinical trials; and the Company's development plans and cost and timeline expectations. Forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially, including, as the Company has disclosed, its ability to continue as a going concern; its need for additional capital and the uncertainty of obtaining it; the risk of clinical-trial delays; the risk that product candidates fail to achieve necessary safety and efficacy endpoints; the risk that the Company's common stock could be delisted if it fails to maintain listing requirements; and other factors detailed in the Company's filings with the SEC at , including its most recent Form 10-K and subsequent Form 10-Q reports. AI-assisted design does not ensure that any candidate will prove safe or effective or receive regulatory approval. References to other companies are based on those companies' public disclosures, are provided for industry context only, and do not imply any partnership, endorsement, affiliation, or comparable performance. TriKE® is a registered trademark of GT Biopharma, Inc. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date made; the publisher undertakes no obligation to update or revise them except as required by applicable law. 21% more press release views with Request a Demo

As recently announced, tovecimig (DLL4 x VEGF-A bispecific antibody) in combination with paclitaxel demonstrated a highly statistically significant improvement in progression-free survival (PFS) versus paclitaxel alone as well as clear signals of a survival benefit in a Phase 2/3 study of patients with biliary tract cancer (BTC); tovecimig previously met the primary endpoint of overall response rate (ORR). Tovecimig received Orphan Drug Designation in April and the Company intends to meet with the FDA in advance of its planned BLA submission later this year. The Phase 1 dose-escalation study of CTX-8371 (PD-1 x PD-L1 bispecific antibody) has been selected for a poster presentation at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting, highlighting three deep responses (TNBC, NSCLC, HL) in patients treated in the post-checkpoint inhibitor setting; cohort expansions in these indications have been initiated. The Phase 1 study for CTX-10726 (PD-1 x VEGF-A bispecific antibody) has also been initiated in the post-checkpoint inhibitor setting, with initial data expected [Q4 2026]. $195 million in cash and marketable securities at Q1 2026, which is expected to fund operations into 2028. BOSTON, May 05, 2026 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today reported first quarter 2026 financial results and provided a business update. “We recently announced positive data from our Phase 2/3 study of tovecimig and look forward to meeting with the FDA before filing a BLA later this year. Most patients with BTC have no approved therapeutic option in the second line setting. Tovecimig, with its strong response rate, striking progression benefit and impact on overall survival would be a compelling treatment alternative for these patients,” said Thomas Schuetz, MD, PhD, Chief Executive Officer and Vice Chairman of the Board of Directors.” “In the post-checkpoint inhibitor setting where treatment alternatives are also critically needed, we have ongoing studies with very two promising candidates. Our novel PD-1 x PD-L1 checkpoint inhibitor CTX-8371 continues to demonstrate strong and durable clinical activity and we look forward to presenting dose-escalation and early expansion cohort data at ASCO. CTX-10726, our differentiated PD-1 x VEGF-A bispecific antibody, is also in a Phase 1 study and we expect to share initial data later this year.” Pipeline Updates: Tovecimig (DLL4 and VEGF-A bispecific antibody) In April 2026, the Company announced data from its Phase 2/3 study of tovecimig, which it plans to include in a BLA submission, to treat patients with biliary tract cancer in the second line setting: Overall Response Rate (primary endpoint): 17.1% for tovecimig combination (n=111), including one complete response, compared to 5.3% for paclitaxel alone (n=57)(p=0.031). Progression-Free Survival (secondary endpoint): 4.7 months for tovecimig combination compared to 2.6 months for paclitaxel alone (HR=0.44, p<0.0001). Overall Survival (secondary endpoint): Analysis was confounded by high crossover from the control arm (n=31) and markedly prolonged survival of these crossover patients after receiving tovecimig. The OS of the patients randomized to the tovecimig combination arm (n=111), which does not include the OS of these crossover patients later treated with tovecimig, was a median of 8.9 months. PFS Before / After Crossover (secondary endpoint): Patients treated with tovecimig after crossing from the control arm progressed after a median 3.5 months (PFS2) in the third line setting. These same 31 patients, when initially randomized to paclitaxel alone (PFS1), had progressed more quickly, with a median of 1.9 months in the second line setting (HR=0.36, p=0.0016). OS Crossover vs. Non-Crossover (post hoc subset analysis): In an analysis of OS in all patients initially randomized to the paclitaxel control arm (n=57), crossover patients who subsequently received tovecimig demonstrated a statistically significant improvement in median OS of 12.8 months compared to 6.1 months for non-crossover patients who received only paclitaxel (n=26)(HR=0.54, p=0.04). Pooled OS of All Patients Treated with Tovecimig (post hoc subset analysis): For all patients treated with tovecimig, including both crossover patients and patients initially randomized to the tovecimig combination arm (n=142), the pooled median OS was 9.8 months. The median OS for patients randomized to the paclitaxel alone who did not crossover (n=26) was 6.1 months. Safety : Tovecimig was generally well tolerated and the safety pro consistent with prior studies, with no new safety signals identified. The investigator sponsored trial (IST) of tovecimig in combination with the current first-line, standard-of-care regimen of gemcitabine, cisplatin, and durvalumab in patients with BTC ( NCT05506943 ) is ongoing. The Company is evaluating multiple additional studies for tovecimig in other indications, including both ISTs and Company-sponsored studies. CTX-8371 (PD-1 x PD-L1 bispecific antibody) Cohort expansions for CTX-8371 have been initiated in patients with triple-negative breast cancer (TNBC, n=28), non-small cell lung cancer (NSCLC, n=28), and Hodgkin lymphoma (HL, n=12) in the post-checkpoint inhibitor setting. These indications were selected based on the deep and durable responses observed in these indications in the dose escalation portion of the study. Half of the patients with each tumor type will be dosed at 3.0 mg/kg and half will be dosed at 10.0 mg/kg. Initial data from these cohort expansions, as well as available data from the Phase 1 dose-escalation portion of the study, will be presented at ASCO 2026. Additional data from the cohort expansions are expected in the fourth quarter of 2026. CTX-10726 (PD-1 x VEGF-A bispecific antibody) The Phase 1 study has been initiated with clinical data expected in the fourth quarter of 2026. The Phase 1 multiple ascending dose-escalation study will include four doses (0.3, 1.0, 3.0, and 10.0 mg/kg) in a 3+3 dose-escalation design. The multi-center study will enroll patients with a prioritized set of solid tumor indications, including patients with locally advanced, unresectable or metastatic renal cell carcinoma, gastroesophageal cancer, hepatocellular carcinoma, and endometrial cancer, in whom standard of care therapies have failed. CTX-10726 is a tetravalent PD-1 x VEGF-A bispecific antibody discovered and engineered by the Company. CTX-10726 exhibits more potent PD-1 blockade compared with data reported for other drugs in the class and the Company believes it has a unique understanding of aspects of its mechanism of action that will guide development. CTX-471 (CD137 or 4-1BB agonist antibody) Initiation of the Phase 2 trial of CTX-471 in patients with tumors expressing NCAM (CD56) is expected in the second half of 2026. Financial Results Net loss for the quarter ended March 31, 2026, was $18.3 million or $0.10 per common share, compared to $16.6 million or $0.12 per common share for the same period in 2025. Research and Development (R&D) Expenses R&D expenses were $13.4 million for the quarter ended March 31, 2026, as compared to $13.1 million for the same period in 2025, an increase of $0.3 million or 3%. General and Administrative (G&A) Expenses G&A expenses were $6.9 million for the quarter ended March 31, 2026, as compared to $4.9 million for the same period in 2025, an increase of $2.0 million or 41%. The increase was primarily driven by pre-commercialization expenses of $1.0 million and higher stock compensation (excluding stock compensation related to pre-commercialization) of $1.4 million. Cash Position As of March 31, 2026, cash and marketable securities were $195 million as compared to $209 million as of December 31, 2025, a decrease of $14 million, with an anticipated cash runway into 2028. During the first quarter of 2026, $18 million of net cash was used in operating activities, and this was partially offset by proceeds from exercise of common stock of $4 million. About Compass Therapeutics Compass Therapeutics, Inc. is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company’s scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. Compass has built a robust pipeline of novel product candidates designed to target multiple critical biological pathways required for an effective anti-tumor response. These pathways include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. The company plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. The Company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics website at Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Compass’s financial position to continue advancing its product candidates, expectations about cash runway, business and development plans, and statements regarding Compass’s product candidates, including their development and clinical trial milestones such as the expected trial design, timing of enrollment, patient dosing and data readouts, regulatory plans with respect to Compass’s product candidates and the therapeutic potential thereof. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at , including without limitation Compass’s latest Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC. Investor Contact ir@compasstherapeutics.com Media Contact Anna Gifford, Chief of Staff media@compasstherapeutics.com 617-500-8099 Compass Therapeutics, Inc. and Subsidiaries Consolidated Statement of Operations (unaudited) (In thousands, except per share data) Three Months Ended March 31, 2026 2025 (unaudited) Operating expenses: Research and development $ 13,390 $ 13,054 General and administrative 6,909 4,912 Loss from operations (20,299 ) (17,966 ) Interest income 1,982 1,333 Net loss $ (18,317 ) $ (16,633 ) Net loss per share - basic and diluted $ (0.10 ) $ (0.12 ) Basic and diluted weighted average shares outstanding 186,400 138,236 Compass Therapeutics, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (In thousands, except par value) March 31, 2026 December 31, 2025 (unaudited) Assets Current assets: Cash and cash equivalents $ 55,168 $ 30,643 Marketable securities 139,519 178,263 Prepaid expenses and other current assets 1,000 913 Total current assets 195,687 209,819 Property and equipment, net 169 102 Operating lease, right-of-use ("ROU") asset 8,746 9,099 Other assets 568 568 Total assets $ 205,170 $ 219,588 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 906 $ 1,585 Accrued expenses 8,000 11,383 Operating lease obligations, current portion 1,373 1,000 Total current liabilities 10,279 13,968 Operating lease obligations, long-term portion 8,418 8,829 Total liabilities 18,697 22,797 Total stockholders' equity 186,473 196,791 Total liabilities and stockholders' equity $ 205,170 $ 219,588