On March 4, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that members from its executive leadership team will be attending and participating at BIO Europe Spring taking place March 17-19, 2025 in Milan, Italy (Press release, Genprex, MAR 4, 2025, View Source [SID1234650879]).

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In attendance will be Ryan Confer, President and Chief Executive Officer and Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing. Throughout the duration of the conference, Genprex executives will be available to conduct one-on-one meetings with industry groups to provide an overview of the Company’s gene therapies for cancer and diabetes.

For those interested in meeting with Genprex management during the conference, please request a meeting through the conference meeting portal or by contacting Investor Relations at [email protected]. The event is expected to bring together more than 3,700 executives from biotech, pharma and finance companies to engage in more than 20,000 one-on-one meetings.

On March 4, 2025 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary TriKE natural killer (NK) cell engager platform, reported that Jeffrey Miller, MD1 from the University of Minnesota Medical School will participate as an expert speaker at the 10th Anniversary of the Innate Killer Summit being held March 3-5, 2025 in San Diego, CA (Press release, GT Biopharma, MAR 4, 2025, View Source [SID1234650880]).

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10th Anniversary of the Innate Killer Summit

Title: Showcasing Advantages of Tri-Specific Killer Engagers to Turbocharge NK Recruitment & Potency
Date: Tuesday, March 4, 2025
Time: 1:30 pm PT
Participant: Dr. Jeffrey Miller, MD, Deputy Director, Masonic Cancer Center, Co-Leader Immunology Program at the University of Minnesota Medical School & Consulting Senior Medical Director, GT Biopharma

Dr. Miller will speak to the mechanisms by which tri-specific engagers enhance NK cell activity, their unique ability to work synergistically with NK cells to improve cytotoxicity and increase cytokine release, and the preclinical and clinical data shown to date.

GTB-3650, GT Biopharma’s wholly owned second-generation TriKE, is currently being evaluated in a Phase 1 dose escalation study in patients with hematological malignancies. Enrollment is proceeding as expected, marking consistent advancement in the trial which will evaluate GTB-3650 in up to approximately 14 patients (seven cohorts) with relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The company anticipates sharing initial data from the study in 2025. More details can be found on clinicaltrials.gov with the identifier: NCT06594445.

On March 4, 2025 Inmune Bio presented its corporate presentation (Presentation, INmune Bio, MAR 4, 2025, View Source [SID1234650881]).

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On March 4, 2025 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, reported its fourth quarter and full year 2024 financial results and provided a corporate update (Press release, Instil Bio, MAR 4, 2025, View Source [SID1234650882]).

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Recent Highlights:

Clinical data for AXN-2510 (formerly SYN-2510) /IMM2510 anticipated in 1H 2025: Instil announced today that ImmuneOnco anticipates providing a clinical data update for AXN-2510/IMM2510 monotherapy in relapsed or refractory (R/R) non-small cell lung cancer ("NSCLC") in the first half of 2025. Instil anticipates that ImmuneOnco will also release safety data from a total of approximately 100 patients treated with AXN-2510/IMM2510 as monotherapy across multiple solid tumors.
Initiation by ImmuneOnco of Phase 1b/2 trial of AXN-2510/IMM2510 in combination with chemotherapy in NSCLC in China: ImmuneOnco announced enrollment of the first patient in the safety run-in of a Phase 1b/2 trial of AXN-2510/IMM2510 in combination with chemotherapy in NSCLC in China in January 2025. ImmuneOnco anticipates enrollment of first-line NSCLC patients in this study to initiate in Q2 2025, with initial clinical data anticipated in 2H 2025.
U.S. clinical study of AXN-2510/IMM2510 in combination with chemotherapy in 1L NSCLC anticipated to commence before the end of 2025: Instil anticipates initiating a U.S. clinical trial of AXN-2510/IMM2510 in combination with chemotherapy for 1L NSCLC patients before the end of 2025, assuming the necessary regulatory approvals are obtained.
Fourth Quarter and Full Year 2024 Financial and Operating Results:

As of December 31, 2024, Instil had $115.1 million in total cash, cash equivalents, restricted cash and marketable securities, which consisted of $8.8 million in cash and cash equivalents, $1.8 million in restricted cash and $104.5 million in marketable securities, compared to $175.0 million in total cash, cash equivalents, restricted cash and marketable securities, which consisted of $9.2 million in cash and cash equivalents, $1.5 million in restricted cash, $141.2 million in marketable securities and $23.2 million in long-term investments, as of December 31, 2023. Instil expects that its cash, cash equivalents, restricted cash and marketable securities as of December 31, 2024 will enable it to fund its current operating plan beyond 2026.

In-process research and development expenses were nil and $10.0 million for the fourth quarter and full year ended December 31, 2024, respectively, compared to nil for the fourth quarter and full year ended December 31, 2023.

Research and development expenses were $1.1 million and $11.8 million for the fourth quarter and full year ended December 31, 2024, respectively, compared to $2.0 million and $39.6 million for the fourth quarter and full year ended December 31, 2023, respectively.

General and administrative expenses were $10.4 million and $44.2 million for the fourth quarter and full year ended December 31, 2024, respectively, compared to $10.9 million and $47.6 million for the fourth quarter and full year ended December 31, 2023, respectively.

Restructuring and impairment charges were $0.3 million and $7.5 million for the fourth quarter and full year ended December 31, 2024, respectively, compared to $0.2 million and $72.0 million for the fourth quarter and full year ended December 31, 2023, respectively.

Net loss per share, basic and diluted was $1.82 and $11.39 for the fourth quarter and full year ended December 31, 2024, respectively, compared to $1.99 and $24.00 for the fourth quarter and full year ended December 31, 2023, respectively. Non-GAAP net loss per share, basic and diluted was $1.08 and $7.59 for the fourth quarter and full year ended December 31, 2024, respectively, compared to $1.26 and $10.14 for the fourth quarter and full year ended December 31, 2023, respectively.

Note Regarding Use of Non-GAAP Financial Measures

In this press release, Instil has presented certain financial information that has not been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"). These non-GAAP financial measures include non-GAAP net loss and non-GAAP net loss per share, which are defined as net loss and net loss per share, respectively, excluding non-cash stock-based compensation expense and restructuring and impairment charges. Instil believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Instil’s financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Instil’s operating results. In addition, these non-GAAP financial measures are among the indicators Instil’s management uses for planning purposes and to measure Instil’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Instil may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer to the below reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.

On March 4, 2025 CStone Pharmaceuticals (stock code: 2616.HK), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer drugs, reported that the first patient has been successfully dosed in a global, multi-center Phase I clinical trial of CS2009, its independently developed PD-1/VEGF/CTLA-4 trispecific antibody, with no infusion reactions or other adverse events (Press release, CStone Pharmaceauticals, MAR 4, 2025, View Source [SID1234656221]).

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The trial will deeply evaluate the clinical application value of CS2009 in a variety of advanced solid tumors, including non-small cell lung cancer, liver cancer, gastric cancer, endometrial cancer, ovarian cancer, renal cell carcinoma and cervical cancer, thereby promoting the innovation and development of tumor immunotherapy.

CS2009 is a novel trispecific antibody independently developed by CStone Pharmaceuticals from the molecular design perspective. It targets three clinically validated targets— PD-1, VEGFA, and CTLA-4 —to achieve multi-dimensional anti-tumor effects through synergistic action. Specifically, PD-1 blockade reverses T cell exhaustion, CTLA-4 blockade promotes T cell activation and proliferation, and VEGFA blockade inhibits tumor angiogenesis, thereby improving the tumor microenvironment (TME). Within the TME, the dual PD-1 and CTLA-4 blockade is significantly enhanced by cross-linking with VEGFA. Furthermore, CS2009 preferentially binds to tumor-infiltrating T cells that are both PD-1 and CTLA-4 positive, while minimizing interference with the CTLA-4 regulatory pathway in peripheral T cells. This innovative molecular design is expected to enhance efficacy while minimizing systemic toxicity.

Preclinical studies have shown that CS2009’s anti-tumor activity is superior to that of potential competitors. Furthermore, by combining CTLA-4 inhibition with PD-1 and VEGFA targeting, CS2009 is expected to further enhance the efficacy of PD-L1-low or PD-L1-negative patients who have poor responses to PD-(L)1 therapy . This potential makes CS2009 a first-in-class/best-in-class next-generation immuno-oncology backbone product, potentially replacing existing PD-(L)1-based therapies .

Dr. Jianxin Yang, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, said: "The successful initiation of the first-in-human study of CS2009 marks the official entry of this innovative therapy into the clinical validation phase. Existing preclinical data have demonstrated its potential across a broad range of indications. In vitro data demonstrate that CS2009 specifically activates tumor-infiltrating T cells and effectively synergizes with VEGF antagonism . In immunocompetent mouse models, CS2009 demonstrated superior tumor killing efficacy compared to both PD-1/CTLA-4 and PD-1/VEGF dual antibodies . Toxicology studies have demonstrated that the safe dose level of CS2009 is significantly higher than that of PD-1/CTLA-4 dual antibodies and comparable to that of PD-1/VEGF dual antibodies . Based on this, we are confident in the clinical potential of CS2009 and look forward to the early release of clinical data further demonstrating its excellent safety profile and anti-tumor activity, which will open a new chapter for the next generation of cancer immunotherapy."

Dr. Qingmei Shi, Chief Medical Officer of CStone Pharmaceuticals, said , "We are delighted to see CS2009 successfully achieve the first patient dose milestone. As an innovative trispecific antibody, CS2009 not only balances efficacy and safety, but also has the potential to overcome the treatment bottleneck for patients with low or negative PD-L1 expression . We look forward to rapid and positive progress in this study, providing better treatment options for solid tumor patients worldwide. We are also very grateful to the CStone clinical team for completing the entire process from Australian clinical trial application submission to first patient dosing in just over two months, despite multiple domestic and international holidays. This fully demonstrates CStone’s exceptional clinical development efficiency and unwavering commitment to serving patients."

Currently, CS2009 is first conducting a multi-center Phase I clinical trial in Australia, and will gradually expand to China and the United States in the future.

About CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody)

CS2009 is a trispecific molecule targeting PD-1, VEGFA, and CTLA-4. As a trispecific antibody targeting large tumor types, it holds first-in-class/best-in-class potential. CS2009 boasts a differentiated molecular design, combining three clinically validated targets to reactivate near-exhausted tumor-infiltrating T cells and demonstrates VEGF neutralization activity comparable to that of existing anti-VEGF antibodies. It covers a wide range of disease indications, including non-small cell lung cancer, liver cancer, gastric cancer, endometrial cancer, ovarian cancer, renal cell carcinoma, and cervical cancer.

In November 2024, CStone Pharmaceuticals presented preclinical data for CS2009 at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). These data demonstrated that CS2009 exhibited significantly superior anti-tumor activity compared to potential competing products, including dual PD-1/CTLA-4 antibodies, dual PD-1/VEGF antibodies, and anti-PD-1/anti-CTLA-4 combination therapies.