On March 12, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported financial results and business highlights for the fourth quarter and year ended December 31, 2025. Lyell has since commenced patient dosing in the first-of-its-kind Phase 3 head-to-head CAR T-cell randomized controlled clinical trial of rondecabtagene autoleucel (ronde-cel) versus investigator’s choice of axicabtagene ciloleucel (axi-cel) or lisocabtagene maraleucel (liso-cel) in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) with disease progression on at least one prior line of therapy (PiNACLE-H2H). Lyell has dosed seven new patients with metastatic colorectal cancer (mCRC) with LYL273, an enhanced guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate, since its November 2025 acquisition, without dose-limiting toxicity and including dose escalation to Dose Level 3.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Lyell also recently announced it has closed the sale of an additional $50 million of shares of its common stock to investors from its July 2025 equity private placement of up to $100 million, following achievement of a clinical milestone within its PiNACLE pivotal trial evaluating ronde-cel in patients with R/R LBCL in the third- or later-line setting (3L+), and the appointment of Smital Shah as its Chief Financial and Business Officer.

"Lyell is on track to achieve multiple clinical milestones in the next 12 to 18 months. We have now advanced ronde-cel into two pivotal clinical trials, with the pivotal data supporting BLA submission from the PiNACLE trial expected to be reported mid-next year," said Lynn Seely, M.D., President and Chief Executive Officer of Lyell. "With the encouraging emerging safety profile and clinical activity observed with LYL273 in patients with metastatic colorectal cancer, we believe Lyell is well-positioned with two next-generation CAR T‑cell product candidates."

Fourth Quarter Updates and Recent Business Highlights

Ronde-cel: A next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to approved CD19‑targeted CAR T-cell therapies for the treatment of LBCL

Ronde-cel is an autologous CAR T-cell product candidate with a true ‘OR’ logic gate to target B cells that express either CD19 or CD20 with full potency and is manufactured with a process that enriches for CD62L-positive cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity. Ronde-cel has received from the U.S. Food and Drug Administration (FDA) Regenerative Medicine Advanced Therapy (RMAT) designation as well as Fast Track designation for the treatment of adults with R/R LBCL.

•The pivotal PiNACLE single-arm trial is a seamless expansion of the 3L+ cohort in the Phase 1/2 multi-cohort trial and is evaluating ronde-cel at a dose of 100 x 106 CAR T cells in patients with R/R LBCL. The trial is expected to enroll approximately 120 patients in the inpatient or outpatient setting, and there is no upper age limit for eligibility. The primary endpoint of the trial is the overall response rate, including an evaluation of duration of response.

•Patient dosing commenced in February 2026 in PiNACLE-H2H, the Phase 3 randomized controlled trial evaluating ronde-cel versus investigator’s choice of axi-cel or liso-cel in patients with R/R LBCL in the 2L setting. The trial is expected to enroll approximately 400 patients (200 per arm) at sites in the US, Canada and Australia. Patients may be treated in either the inpatient or outpatient setting. The trial’s primary endpoint is event-free survival.
•Updated data from the ongoing Phase 1/2 clinical trial were presented at the December 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2025):
◦A best overall response rate of 93% and a complete response rate of 76% in 29 efficacy-evaluable patients with R/R LBCL in the 3L+ setting. The median progression-free survival was 18 months as of the data cutoff date of September 5, 2025.
◦Data were also presented from the 2L cohort in the Phase 1/2 multi-cohort clinical trial, including an efficacy-evaluable population of 18 patients (94% with high-risk primary refractory disease) and demonstrated an 83% best overall response rate and a 61% complete response rate.
◦The safety profile was appropriate for outpatient administration. Data from 25 patients treated with ronde-cel who received dexamethasone prophylaxis in the 3L+ and 2L settings revealed no events of ≥ Grade 3 cytokine release syndrome and a 4% rate of ≥ Grade 3 immune cell-associated neurotoxicity syndrome.
LYL273 (formerly known as GCC19CART): A next-generation GCC-targeted CAR T-cell product candidate for the treatment of mCRC and other GCC-expressing cancers
LYL273 is a GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release, designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile tumor microenvironment. In November 2025, we acquired global rights (excluding mainland China, Hong Kong, Macau and Taiwan) to LYL273, which has shown promising dose-dependent clinical activity in patients with advanced mCRC in a Phase 1 trial conducted in the U.S. LYL273 received from the FDA Fast Track designation for the treatment of mCRC.
•The U.S. Phase 1 clinical trial is continuing to enroll patients to determine the recommended Phase 2 dose. Seven additional patients with mCRC have been treated with LYL273 since the November 2025 acquisition without dose-limiting toxicity and including dose escalation to Dose Level 3.

•A 67% best overall response rate, an 83% disease control rate and an 8-month median progression-free survival with a manageable safety profile have been reported at the highest dose level tested as of the data cutoff date of October 28, 2025 (Dose Level 2) in patients with refractory mCRC in the U.S. Phase 1 clinical trial.

Fourth Quarter and Full Year 2025 Financial Results

Lyell reported a net loss of $140.7 million and $274.4 million for the fourth quarter and year ended December 31, 2025, respectively, compared to a net loss of $191.9 million and $343.0 million for the same periods in 2024. Net loss for the fourth quarter and year ended December 31, 2025 included $66.3 million in acquired in-process research and development (IPR&D) expense as part of the acquisition of our rights to LYL273, and $19.7 million in stock-based compensation expense for an equity milestone deemed probable related to the LYL273 license acquisition. Net loss for the fourth quarter and year ended December 31, 2024 included $87.2 million in acquired IPR&D expense as part of our acquisition of ImmPACT Bio and $51.3 million of long‑lived asset impairment expense. Non‑GAAP net loss, which excludes stock-based compensation, non-cash expenses related to the change in the estimated fair value of success payment liabilities and securities purchase agreement put/call liability, long‑lived asset impairment expense and certain non-cash investment gains and charges, was $33.1 million and $144.8 million for the fourth quarter and year ended December 31, 2025, respectively, compared to $45.9 million and $159.5 million for the same periods in 2024.

GAAP and Non-GAAP Operating Expenses

•Research and development (R&D) expenses were $52.2 million for the fourth quarter ended December 31, 2025, compared to $48.7 million for the same period in 2024. The increase in fourth quarter 2025 R&D expenses of $3.5 million was primarily due to $19.7 million in stock-based compensation expense for an equity milestone deemed probable related to the LYL273 license acquisition. The increase in fourth quarter 2025 R&D expenses was partially offset by an $8.9 million reduction in personnel costs and a $4.7 million reduction in additional facilities and technology costs primarily due to reduced headcount following the successful technology transfer of ronde-cel to our LyFE Manufacturing CenterTM (LyFE) and associated workforce reduction in the first half of 2025. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities for the fourth quarter ended December 31, 2025, were $30.1 million compared to $45.4 million for the same period in 2024 due to the workforce reduction related to the successful technology transfer of ronde-cel.
•General and administrative (G&A) expenses were $10.6 million for the fourth quarter ended December 31, 2025, compared to $14.5 million for the same period in 2024. The decrease in fourth quarter 2025 G&A expenses of $3.9 million was primarily due to a $4.1 million decrease in personnel costs associated with the workforce reduction related to the successful ronde-cel technology transfer, partially offset by a $0.8 million increase in collaborations and licenses expenses.
A discussion of non-GAAP financial measures, including reconciliations of the most comparable U.S. generally accepted accounting principles (GAAP) measures to non‑GAAP financial measures, is presented below under "Non-GAAP Financial Measures."
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of December 31, 2025 were approximately $247.2 million (excluding the $50 million tranche received in March 2026), compared to approximately $383.5 million as of December 31, 2024. Lyell believes that its current cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into the second quarter of 2027.

(Press release, Lyell Immunopharma, MAR 12, 2026, View Source [SID1234663501])

On March 12, 2026 Enodia Therapeutics, a biotechnology company developing novel small-molecule therapies for targeted protein degradation at the point of synthesis, and Kezar Life Sciences, Inc. (Nasdaq:KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, reported that Enodia has acquired Kezar’s assets from its Sec61-based discovery and development program. The acquisition enables Enodia to advance its understanding of Sec61 selectivity mechanisms, expanding biological and translational insights for faster progression toward key clinical milestones.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the purchase agreement between Enodia and Kezar, Kezar will receive an initial upfront payment totaling $1 million, and will receive future payments upon achievement of certain development, regulatory and commercialization milestones, for a potential total of up to $127 million. Enodia has also agreed to pay tiered royalties on net sales.

"Kezar has made significant early advances in the Sec61 field with the discovery of small molecule inhibitors," said Yves Ribeill, Chief Executive Officer of Enodia Therapeutics. "By integrating Kezar’s extensive preclinical datasets into our selective targeted protein degradation platform, this acquisition enhances our ability to make accelerated, yet informed development decisions across our candidate programs."

Enodia’s proprietary platform enables selective Sec61 Translocon modulation, a novel approach to inhibit disease-relevant proteins at the point of their synthesis before pathological effects occur, while preserving essential physiological functions. Enodia has built a broad and well-characterized chemical space spanning multiple Sec61 inhibitor families, supported by extensive biological datasets, including proteomics, Cryo-EM and tailored cell line libraries to enable rational small-molecule drug design powered by machine learning. Insights from Kezar’s Sec61-based programs will further strengthen Enodia’s core focus on Sec61-driven selectivity for targeting protein degradation.

"Kezar has spent nearly ten years pioneering research and drug discovery efforts around the Sec61 translocon and continues to have strong conviction in this novel target," said Chris Kirk, PhD, CEO of Kezar Life Sciences. "The team at Enodia is poised to make great progress in this space, and we are excited to see our efforts being carried on and expanded upon."

(Press release, Enodia Therapeutics, MAR 12, 2026, View Source [SID1234663500])

On March 12, 2026 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported its financial results for the fourth quarter and full year ended December 31, 2025 and provided an update on recent company developments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With our first BLA now under review by the FDA, we are focused on delivering INO-3107 to RRP patients who are desperate for treatment options that reduce reliance on surgery to control this rare and devastating disease," said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer. "Our top priority is advancing INO-3107, and to do so, optimizing and extending our financial resources towards our target PDUFA date of October 30, 2026. We are excited about the opportunities ahead as we prepare to become a commercial-stage company and work to leverage the power of partnerships to advance other promising candidates in our pipeline. I look forward to providing more updates on our progress with these efforts in the coming months."

Operational Highlights

INO-3107 – Recurrent Respiratory Papillomatosis (RRP)
In December 2025, the FDA accepted INOVIO’s BLA for INO-3107 for review under the accelerated approval program as a potential treatment for adults with RRP. As part of the submission, INOVIO requested a priority review, which is typically 6 months. Instead, the FDA granted a standard 10-month review with a PDUFA target date set for October 30, 2026.

While the BLA was accepted under the accelerated approval program, in the file acceptance letter the FDA noted as a potential review issue its preliminary conclusion that the company had not provided adequate information to justify eligibility for the accelerated approval pathway. INOVIO continues to strongly believe that INO-3107 fulfills the criteria for accelerated approval, meeting a significant unmet need and providing a meaningful therapeutic benefit over existing treatments. The FDA has agreed to a yet-to-be-scheduled meeting to discuss eligibility for review under the accelerated approval program.

During 2025, INOVIO published clinical and immunological results from its Phase 1/2 trial (RRP-001) in Nature Communications showing that INO-3107 induced new populations of T cells in the blood that traveled to airway tissue and were associated with significant clinical benefit as measured by reduced need for surgery. INOVIO also published data from a retrospective study (RRP-002) investigating the long-term safety and clinical response of patients treated with INO-3107 in The Laryngoscope. Data demonstrated that the majority of patients experienced continued improvement beyond the initial 12-month study period of the previously published Phase 1/2 trial (RRP-001), as measured by a reduction in the number of surgical procedures needed after treatment with INO-3107.

INOVIO also continued to advance commercial readiness plans, including conducting critical market research supporting a positively differentiated product profile, developing a pricing strategy, finalizing our go-to-market model, and advancing the build-out of our commercial organization. We’ve also selected key commercial partners including a third-party logistics provider, Agency of Record, specialty distributor, specialty pharmacy, and patient HUB.

INO-5412/INO-5401
INOVIO announced a clinical trial collaboration and supply agreement with Akeso Inc. to evaluate INO-5412 (INO-5401 plus INO-9012 in a single vial) in combination with cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, for the potential treatment of GBM. The combination therapy will be studied as a part of the INdividualized Screening trial of Innovative Glioblastoma Therapy (INSIGhT), the innovative Phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute and conducted by Mass General Brigham Cancer Care Inc. that is designed to quickly and efficiently find new treatments for GBM. The novel combination of INO-5412 with cadonilimab builds on INOVIO’s previous promising research in GBM and could potentially benefit patients by providing additional checkpoint inhibition through CTLA-4 binding.

INOVIO also continues to dose patients in the GBM-001 Phase 1/2 trial in newly diagnosed glioblastoma that combines INO-5401 plus INO-9012 with Regeneron’s PD-1 checkpoint inhibitor Libtayo.

INOVIO’s partners at the Basser Center at the University of Pennsylvania continue to evaluate the tolerability and immunogenicity of INO-5401 plus INO-9012 in a Phase 1 study exploring the potential to prevent cancer in people with BRCA1 or BRCA2 mutations.

Next Generation DNA Medicine Candidates
Results from a Phase 1 proof-of-concept trial evaluating next generation DMAbs for COVID-19 were published online in Nature Medicine, demonstrating the technology’s potential as a long-acting, scalable and tolerable alternative to traditional monoclonal antibody therapies. The study is being led by The Wistar Institute in collaboration with INOVIO, AstraZeneca, and clinical investigators at the Perelman School of Medicine at the University of Pennsylvania. This was the first demonstration that DNA plasmid encoded monoclonal antibodies, which are complex proteins, can be durably and tolerably expressed in humans.

INOVIO also presented promising Factor VIII preclinical data from its DPROT program at the World Federation of Hemophilia Global Forum in November 2025. This technology aims to address some of the shortcomings of conventional therapeutic protein replacement treatments, including gene therapy approaches. INOVIO is developing additional DPROT indications and is actively seeking partners to accelerate development of this promising program.

General Corporate
INOVIO remains focused on financial discipline, directing resources to advance the INO-3107 program towards commercialization and a potential approval date in October 2026, and extending the cash runway. To achieve this goal, INOVIO has further prioritized programs, spending, and resource needs, and has eliminated roles that don’t directly support our primary goal of advancing INO-3107 toward US approval.

2025 Financial Results

Research and Development (R&D) Expenses: R&D expenses for the quarter and year ended December 31, 2025 were $10.3 million and $54.2 million, respectively, compared to $12.9 million and $75.6 million for the same periods in 2024. The decrease was due primarily to the result of lower drug manufacturing, clinical study and other expenses related to INO-3107, lower contract labor and lower expensed inventory, among other variances.

General and Administrative (G&A) Expenses: G&A expenses were $7.2 million and $32.7 million, respectively, for the quarter and year ended December 31, 2025, versus $7.6 million and $37.0 million, respectively, for the same periods in 2024. The decrease in G&A expenses was primarily related to a decrease in employee and consultant compensation, including stock-based compensation, among other variances.

Total Operating Expenses: Total operating expenses were $17.5 million and $86.9 million for the quarter and year ended December 31, 2025, respectively, compared to $20.5 million and $112.6 million for the same periods in 2024.

Net Loss: INOVIO’s net income (loss) for the quarter and year ended December 31, 2025 was $3.8 million, or $0.06 per basic and ($0.26) per diluted share, and ($84.9) million, or ($1.81) per basic and diluted share, respectively, compared to net loss of $19.4 million, or $0.65 per basic and diluted share, and $107.3 million, or $3.95 per basic and diluted share, for the quarter and year ended December 31, 2024, respectively. The net income for the fourth quarter 2025 was primarily driven by a $21.2 million non-cash gain on fair value adjustment related to our warrant liabilities. As the fair value of the warrants fluctuates with our share price and other market inputs, this adjustment can result in significant variability in our reported net income (loss).

Shares Outstanding: As of December 31, 2025, INOVIO had 69.0 million common shares outstanding and 109.7 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting, and conversion, as applicable, of its outstanding common stock warrants, stock options, restricted stock units and convertible preferred stock.

Cash, Cash Equivalents and Short-term Investments: As of December 31, 2025, cash, cash equivalents and short-term investments were $58.5 million compared to $94.1 million as of December 31, 2024.
INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s annual report on Form 10-K for the year ended December 31, 2025, which can be accessed at: View Source

Cash Guidance
INOVIO estimates its current cash, cash equivalents and short-term investments balances to support the company’s operations into the fourth quarter of 2026. This projection includes an operational net cash burn estimate of approximately $22 million for the first quarter of 2026. These cash runway projections do not include any further capital-raising activities that INOVIO may undertake.

Conference Call / Webcast Information
INOVIO’s management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO’s financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

(Press release, Inovio, MAR 12, 2026, View Source [SID1234663499])

On March 12, 2026 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta ("γδ") T cell therapies and γδ T cell engagers for cancer and autoimmune diseases, reported financial results and business highlights for the fourth quarter and full-year ended December 31, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2025, we delivered meaningful progress financially and across our clinical γδ T cell therapy programs and our next-generation T cell engager platform," said William Ho, co-founder and Chief Executive Officer of IN8bio. "Our deep knowledge of γδ T cell biology and their powerful immune properties enables us to create potential first-in-class or best-in-class programs to address significant unmet medical needs. Last year, we reported updated survival data from our INB-200 and 400 Phase 1 and 2 programs in GBM, along with data from a contemporaneously enrolled standard-of-care ("SOC") control group. Patients treated with our DeltEx DRI γδ T cells nearly doubled the mPFS, compared to the SOC group, despite a higher number of patients receiving only partial resections. These findings underscore the aggressive nature of GBM, even with SOC treatment, and highlight the significant need for new treatment options. Importantly, our recent financing strengthens our balance sheet and is expected to extend our cash runway to allow us to advance multiple high-value programs. With differentiated science, advancing clinical programs, and a novel TCE platform, we believe IN8bio is well positioned to achieve key milestones and deliver value to shareholders and patients in 2026."

Key Highlights

Strengthened Balance Sheet with up to $40.2 Million Private Placement

In December 2025, IN8bio announced a private placement of up to $40.2 million in gross proceeds, including $20.1 million in an initial closing and the potential for an additional milestone-based $20.1 million.

Financing led by Coastlands Capital, with participation from new and existing investors.
Net proceeds of $18.5 million expected to extend the Company’s cash runway into the first half of 2027.
Proceeds intended to support IND-enabling studies for INB-619 γδ TCE, further discussions with the FDA on potential clinical pathways for the GBM program, continued advancement of the Company’s γδ T cell therapy programs, and general corporate purposes.
Presented Updated Clinical Data Demonstrating Durable Survival Improvements in Newly Diagnosed Glioblastoma

In January 2026, IN8bio reported updated data from its INB-200 Phase 1 and INB-400 Phase 2 trials evaluating DeltEx DRI γδ T cells in newly diagnosed GBM. The data included a contemporaneous SOC control group from multiple clinical sites.

mPFS for repeat dose DeltEx DRI patients was 13.0 months vs. 6.6 months for SOC control cohort (+97% improvement).
Median overall survival ("mOS") in repeat dose patients had not yet been reached at 17.2+ months, surpassing the 13.2-month final mOS for SOC control arm.
Several patients remained progression-free beyond two years, and one grade 4 glioma patient remains progression-free for greater than 4.5 years, highlighting the long-term benefit of INB-200.
No dose-limiting toxicities ("DLTs"), cytokine release syndrome ("CRS"), neurotoxicity ("ICANS"), tumor inflammation-associated neurotoxicity ("TIAN") or other unexpected severe adverse events were observed.
Results reinforce the potential of repeat-dose γδ T cell therapy to meaningfully improve outcomes in newly diagnosed glioblastoma and support continued regulatory engagement regarding potential clinical pathways.
Continued Advancing Next-Generation Gamma-Delta T Cell Engager Platform

Continued advancing INB-600 platform, featuring novel γδ T cell engagers designed to potentially improve durability and safety compared with traditional CD3-targeting engagers.
Progressing INB-619, a CD19-targeting γδ T cell engager for potential use in oncology and autoimmune diseases into IND-enabling studies with initial animal data expected in 2026.
Presented encouraging preclinical data including complete B-cell depletion, robust γδ T cell expansion, and minimal CRS-associated cytokine release at The American College of Rheumatology ("ACR") Convergence 2025 meeting, supporting differentiation of the platform.
Leadership Update

In February 2026, IN8bio announced the promotion of Kate Rochlin, Ph.D., to President and Chief Operating Officer. Dr. Rochlin has played a central role in advancing the Company’s clinical and preclinical programs, manufacturing capabilities, and strategic execution, and will continue overseeing company operations as IN8bio advances its pipeline and prepares for its next phase of growth.

Anticipated Milestones

Guidance from the FDA on potential regulatory pathway by the second half of 2026
Additional clinical updates on our GBM programs, including final mOS data from the total data set, at medical meetings in mid- and late-2026
Initial preclinical animal data and additional IND-enabling data for INB-619 expected in the second half of 2026
Completion of patient dosing in INB-100 in early 2026 and report long-term follow-up results at a medical meeting in late 2026
Fourth Quarter and Full Year 2025 Financial Highlights

IN8bio significantly improved its financial profile in 2025, reducing its full-year net loss by 36% year-over-year and ending the year with more than double the cash on hand compared to the prior year.

Cash position: As of December 31, 2025, the Company had cash of $27.1 million, compared with $11.1 million as of December 31, 2024.
Research and Development (R&D) expenses: R&D expenses were $2.6 million for the three months ended December 31, 2025, compared with $3.6 million for the comparable prior year period. R&D expenses were $10.2 million for the year ended December 31, 2025, compared with $17.0 million in the prior year. Non-cash stock-based compensation expense included in R&D expense was $1.2 million for the full year 2025 and $0.3 million for the fourth quarter of 2025.
General and administrative (G&A) expenses: G&A expenses were $2.4 million for the three months ended December 31, 2025, compared with $2.6 million for the comparable prior year period. G&A expenses were $9.7 million for the year ended December 31, 2025, compared with $12.6 million in the prior year. Non-cash stock-based compensation expense included in G&A expense was $2.0 million for the full year 2025 and $0.4 million for the fourth quarter of 2025.
Severance and related charges: Severance and related charges were nil for the year ended December 31, 2025, compared with $1.1 million in the prior year.
Net loss: The Company reported a net loss of $4.9 million, or $0.45 per basic and diluted common share, for the three months ended December 31, 2025, compared with a net loss of $6.2 million, or $2.38 per basic and diluted common share, for the comparable prior year period. For the year ended December 31, 2025, net loss was $19.4 million, or $4.44 per basic and diluted common share, compared with a net loss of $30.4 million, or $17.05 per basic and diluted common share, for the prior year.
IN8bio enters 2026 with a strengthened balance sheet, advancing clinical programs, and multiple regulatory milestones ahead. The Company remains focused on generating meaningful clinical data, advancing its γδ T cell platforms toward key inflection points, and deploying capital efficiently across its highest-priority programs across oncology and autoimmune diseases.

(Press release, In8bio, MAR 12, 2026, View Source [SID1234663498])

On March 12, 2026 IMPACT-AML reported that it has entered into an agreement with SELLAS Life Sciences Group, a late-stage clinical biopharmaceutical company focused on developing novel therapies for a broad range of cancer indications. Under the agreement, the IMPACT-AML network will conduct a clinical study evaluating SLS009, a highly selective CDK9 inhibitor, enabling access to multiple European clinical sites and patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

IMPACT-AML is a pan-European project that builds an inclusive clinical network, the STREAM platform, connecting patients, clinicians and researchers to test novel AML therapies and improve patient outcomes. It is part of the EU Mission on Cancer programme and represents a high-level scientific collaboration. The project is led by a consortium of major European research and clinical institutions, including IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST), the University of Bologna, IIS La Fe (Health Research Institute Hospital La Fe), several European AML collaborative groups, and supranational organisations under the umbrella of the European LeukemiaNet (ELN), as well as multiple university hospitals across Europe. By leveraging IMPACT-AML’s existing infrastructure and expertise, SELLAS expects to expand European patient access to SLS009 in a cost-efficient manner while supporting broader participation across the clinical programme.

"This is a highly meaningful milestone for SELLAS and for the SLS009 programme," said Angelos Stergiou, M.D., Sc.D., President and Chief Executive Officer of SELLAS. "Gaining access to the IMPACT-AML framework represents strong external validation of SLS009 and reflects growing recognition of its potential to address critical unmet needs in AML. Importantly, this collaboration allows us to expand our clinical programme into Europe efficiently by leveraging an established infrastructure, improving capital efficiency while supporting broader and faster patient enrolment as we advance into frontline AML".

The collaboration is expected to support continued execution of the SLS009 clinical programme as SELLAS advances into frontline AML. The European study is planned to enrol approximately 40 patients to evaluate SLS009 in combination with azacitidine and venetoclax (AZA/VEN) in patients with newly diagnosed AML with high-risk features. Enrolment in the first part of the trial for newly diagnosed patients is expected to begin at US sites in Q1 2026, followed by initiation at European sites in Q2 2026, subject to regulatory approval and site readiness.

"IMPACT-AML is committed to accelerating access to promising new therapeutic approaches for patients with AML who face limited treatment options," said IMPACT-AML Scientific Coordinator Dr Giovanni Martinelli. "We are pleased to collaborate with SELLAS and support the evaluation of SLS009 within our European network, in line with our mission to facilitate efficient, high-quality clinical research in AML."

(Press release, IMPACT-AML, MAR 12, 2026, View Source [SID1234663497])