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 3, 2025 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported financial results for the year ended December 31, 2024, and highlighted recent Company progress (Press release, ArriVent Biopharma, MAR 3, 2025, View Source [SID1234650824]).

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"This has been a productive year for ArriVent that included strong achievement across our firmonertinib clinical programs and significant execution of our company strategy through the expansion of our ADC portfolio. The differentiated potential of firmonertinib to address classical and uncommon EGFR mutations was reinforced by the robust anti-tumor activity in NSCLC patients with EGFR PACC mutations reported at the World Conference on Lung Cancer, and the preclinical data presented at AACR (Free AACR Whitepaper)" said Bing Yao, Chairman and Chief Executive Officer of ArriVent. "We also bolstered our ADC portfolio with the recent in-licensing of ARR-217 (MRG007) and research collaboration with Alphamab, underscoring our commitment to further expand our pipeline and develop new innovative therapies to potentially treat cancer patients with unmet medical need."

Dr. Yao continued, "We have achieved our target enrollment of 375 patients in our global, pivotal Phase 3 monotherapy study of firmonertinib in first-line NSCLC patients with EGFR exon 20 insertion mutations. In addition, we plan to provide an update on our plans to investigate firmonertinib as monotherapy in first line NSCLC patients with EGFR PACC mutations in the first half of 2025. For our ADC portfolio, we selected our next-generation ADC candidate, ARR-002, for IND-enabling activities. Our focus continues to be on executing across our near-term catalysts and we are poised for an impactful year ahead."

Recent and Full Year 2024 Highlights

Firmonertinib

● Achieved target enrollment for the global pivotal Phase 3 monotherapy study of firmonertinib in first-line NSCLC EGFR exon20 insertion mutations (FURVENT; NCT05607550). Earlier this year, ArriVent reached its target enrollment in the FURVENT study. Firmonertinib, an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor, received FDA Breakthrough Therapy Designation in this patient population.
● Positive proof-of-concept data in EGFR PACC mutant NSCLC. In September 2024, ArriVent presented interim Phase 1b clinical data for first-line firmonertinib monotherapy in NSCLC patients with EGFR PACC mutations (FURTHER; NCT05364043) during the Presidential Symposium at the

2024 World Conference on Lung Cancer and hosted a virtual webinar. Firmonertinib demonstrated robust systemic and CNS anti-tumor activity with a manageable safety profile consistent with previous trials in what we believe to be the first clinical dataset testing an EGFR inhibitor in a prospectively defined population of EGFR PACC mutant NSCLC.
● Presentation of preclinical data for firmonertinib at the 2024 AACR (Free AACR Whitepaper) Annual Meeting. In April 2024, ArriVent presented data evaluating firmonertinib in preclinical models with EGFR exon 20 insertion mutations and with P-loop and alpha-c helix compressing (PACC) mutations at the AACR (Free AACR Whitepaper) Annual Meeting. In the preclinical study, firmonertinib was observed to be broadly active across a wide range of uncommon mutations including PACC and exon 20 insertion mutations.
● Initiated Phase 1b combination study with firmonertinib and SHP2 allosteric inhibitor ICP-189. In March 2024, ArriVent’s clinical collaboration partner Beijing InnoCare Pharma Tech Co., Ltd., dosed the first patient in the Phase 1b combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations.
Pipeline

● Added ARR-217 (MRG007) to our pipeline from Lepu Biopharma. In January 2025, ArriVent entered into a collaboration with Lepu Biopharma Co., Ltd. for ARR-217, an ADC with the potential to target several GI cancers. Under the agreement, ArriVent obtained the exclusive rights to develop and commercialize ARR-217 worldwide outside of greater China, which includes mainland China, Hong Kong, Macau and Taiwan.
● Selected a next-generation antibody drug conjugate (ADC) candidate. In late 2024, ArriVent and its partner, Aarvik Therapeutics, Inc., selected a multi-target multivalent ADC candidate, ARR-002, for the treatment of solid tumors. ArriVent has initiated IND-enabling studies for ARR-002.
● Entered into an ADC collaboration agreement with Alphamab. In June 2024, ArriVent entered into a collaboration agreement with Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (Alphamab), a wholly owned subsidiary of Alphamab Oncology, to discover, develop and commercialize novel ADCs for the treatment of cancers. Under the agreement, both companies leverage Alphamab’s proprietary linker-payload platform and glycan-conjugation technology to identify novel ADCs for oncology indications. The collaboration agreement grants ArriVent exclusive rights to develop and commercialize ADCs globally, except greater China, which includes mainland China, Hong Kong, Macau and Taiwan.
Upcoming Milestones

● EGFR PACC plans. Data from the FURTHER Phase 1b (NCT05364043) trial continues to mature for first-line firmonertinib monotherapy in NSCLC patients with EGFR PACC mutations. ArriVent expects to provide an update on our plans to develop firmonertinib in EGFR PACC mutant NSCLC in the first half of 2025.

● First IND Filing for ADC Program. ArriVent and its partner, Lepu BioPharma, plan to file the first IND for ARR-217 in the first half of 2025.

● Top-line pivotal Phase 3 data. Firmonertinib has reached its target enrollment in the FURVENT study. ArriVent anticipates having top-line data in 2025 and expects to provide an update on timing of the top-line Phase 3 data release in Q2 2025.
2024 Financial Results

● As of December 31, 2024, the Company had cash, cash equivalents, and short and long-term investments of $266.5 million, which is expected to fund operations into 2026. Net cash used in operations was $70.2 million and $55.8 million for the years ended December 31, 2024 and 2023, respectively. During 2024, ArriVent completed an IPO raising net proceeds of $183.2 million, after deducting underwriting discounts, commissions, and other offering expenses.

● Research and development expenses were $79.0 million and $64.9 million for the years ended December 31, 2024 and 2023, respectively. The increase in expense was primarily due to increased headcount and clinical expense related to firmonertinib.

● General and administrative expenses were $15.3 million and $9.7 million for the years ended December 31, 2024 and 2023, respectively. The increase in expense was primarily due to expenses related to expanding the infrastructure necessary for operating as a public company.

● Net loss was $80.5 million and $69.3 million for the years ended December 31, 2024 and 2023, respectively.