On November 13, 2025 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151) reported the U.S. Food and Drug Administration (FDA) has granted full approval of KOMZIFTI (ziftomenib) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. KOMZIFTI is the first and only once-daily, oral menin inhibitor approved for R/R NPM1-mutated (NPM1-m) AML, a devastating blood cancer with limited treatment options.

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"KOMZIFTI combines compelling efficacy, a favorable safety profile, compatibility with concomitant medications, and convenient once-daily oral administration in a population with few effective treatment options. These features highlight KOMZIFTI’s potential to serve as the menin inhibitor of choice in its approved indication," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Together with our partner, Kyowa Kirin, we remain committed to advancing development of KOMZIFTI across the treatment continuum for AML, where its best-in-class profile offers potential for even greater impact in combination regimens and earlier lines of therapy. We are fully prepared to launch KOMZIFTI today and deliver this new medicine to patients in need."

NPM1 mutations are among the most common founder mutations in AML, occurring in approximately 30% of cases. Historically, approximately 20% of patients with NPM1-m AML do not respond to front-line therapy. Of those who do respond, 70% will relapse within 3 years, most within 12 months. Early relapse and declining survival with each recurrence underscore the urgent need for treatment approaches that deliver lasting remission.

Approval is supported by the pivotal KOMET-001 trial (NCT04067336), which evaluated KOMZIFTI’s safety and efficacy in 112 R/R NPM1-m AML patients. The rate of complete remission (CR) plus CR with partial hematologic recovery (CRh) was 21.4% (95% CI: 14.2, 30.2). The median duration of CR+CRh was 5.0 months (95% CI: 1.9, 8.1) and the median time to first response in patients who achieved a CR or CRh was 2.7 months (range: 0.9 to 15 months). 88% of patients who achieved CR or CRh did so within 6 months of initiating KOMZIFTI. These data from the Prescribing Information are generally consistent with findings recently published in the Journal of Clinical Oncology.1

"KOMZIFTI addresses a critical need for adult patients with R/R NPM1-m AML, many of whom are older and unable to tolerate intensive chemotherapy or transplant," said Eunice Wang, M.D., Chief of the Leukemia Service and Professor of Oncology at Roswell Park Comprehensive Cancer Center. "The clinical data demonstrate deep and durable responses with a manageable safety profile, including no drug-drug interactions and no Boxed Warnings for QTc prolongation or Torsades de Pointes – key advantages for patients on multiple concurrent medications. This approval equips physicians with a new oral therapy to integrate into care and improve outcomes for this vulnerable patient population."

The most common adverse reactions (≥20%), including laboratory abnormalities, were aspartate aminotransferase increased, infection without an identified pathogen, potassium decreased, albumin decreased, alanine aminotransferase increased, sodium decreased, creatinine increased, alkaline phosphatase increased, hemorrhage, diarrhea, nausea, fatigue, edema, bacterial infection, musculoskeletal pain, bilirubin increased, potassium increased, differentiation syndrome, pruritus, febrile neutropenia, and transaminases increased. KOMZIFTI includes a Boxed Warning for differentiation syndrome, a well-studied mechanism-based risk in drugs that restore differentiation. Absence of clinically meaningful drug-drug interactions can ease the use of KOMZIFTI with concomitant therapies, including those that cause QTc interval prolongation. QTc interval prolongation was ≤ Grade 3 in 12% of patients and no Grade 4 or Grade 5 QTc interval prolongation was reported. QTc interval prolongation of any cause occurred in 10% of the 70 patients 65 years of age or older.

"The approval of KOMZIFTI underscores our commitment to advancing precision medicines to address the genetic drivers of disease in hematology and oncology," said Takeyoshi Yamashita, Ph.D., Executive Vice President and Chief Medical Officer of Kyowa Kirin. "In AML, where many patients face severe disease progression and limited treatment options, the evolution toward targeted therapies such as KOMZIFTI represents a major step forward and offers potential to transform existing standards of care. We are proud to partner with Kura Oncology in bringing this important therapy to patients and their families."

In November 2024, Kura Oncology and Kyowa Kirin entered into a global strategic collaboration to develop and commercialize KOMZIFTI. The collaboration builds on Kyowa Kirin’s leadership and expertise in hematologic malignancies. Under the terms of the collaboration, Kura leads development, regulatory and commercial strategy in the U.S. and is responsible for manufacturing KOMZIFTI. The companies will jointly perform certain commercialization activities in accordance with a co-created U.S. territory commercialization plan. Outside the U.S., Kyowa Kirin leads development, regulatory and commercial strategy and is responsible for commercializing KOMZIFTI.

As part of its commitment to helping patients access KOMZIFTI, Kura has established a support program, Kura RxKonnect, to minimize barriers to access and reimbursement for appropriate patients prescribed KOMZIFTI. Kura RxKonnect is available 8:00 am – 8:00 pm ET by phone at (844) KuraPSP (844-587-2777) or online at www.KuraRxKonnect.com.

Conference Call and Webcast
Kura will host a conference call and webcast featuring Company management and guest speaker Eunice Wang, M.D., Chief of the Leukemia Service and Professor of Oncology at Roswell Park Comprehensive Cancer Center, at 12:30 pm ET / 9:30 am PT on November 13, 2025. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

About KOMZIFTI
KOMZIFTI (ziftomenib) is an oral menin inhibitor approved for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options.

KOMZIFTI is in development for the front-line treatment of AML harboring NPM1 mutations, KMT2A translocations and FLT3 mutations, with the potential to be combined with approved therapies and benefit a broad spectrum of patients earlier in their disease course.

IMPORTANT SAFETY INFORMATION FOR KOMZIFTI FROM THE U.S. PRESCRIBING INFORMATION

Boxed WARNING: DIFFERENTIATION SYNDROME

Differentiation syndrome, which can be fatal, has occurred with KOMZIFTI. Signs and symptoms may include fever, joint pain, hypotension, hypoxia, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, pulmonary infiltrates, acute kidney injury, and rashes. If differentiation syndrome is suspected, interrupt KOMZIFTI, and initiate oral or intravenous corticosteroids with hemodynamic and laboratory monitoring until symptom resolution; resume KOMZIFTI upon symptom improvement.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome

KOMZIFTI can cause fatal or life-threatening differentiation syndrome (DS). DS is associated with rapid proliferation and differentiation of myeloid cells. Symptoms of DS, including those seen in patients treated with KOMZIFTI, may include fever, hypoxia, joint pain, hypotension, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, acute kidney injury, and rashes.

In the clinical trial, DS occurred in 29 (26%) of 112 patients with R/R AML with an NPM1 mutation who were treated with KOMZIFTI at the recommended dosage. DS was Grade 3 in 13% and fatal in two patients. In broader evaluation of all patients with any genetic form of AML treated with KOMZIFTI monotherapy in clinical trials, DS occurred in 25% of patients. Four fatal cases of DS occurred out of 39 patients with KMT2A-rearranged AML treated with KOMZIFTI. KOMZIFTI is not approved for use in patients with KMT2A-rearranged AML.

In the 112 patients with an NPM1 mutation, DS was observed with and without concomitant hyperleukocytosis, in as early as 3 days and up to 46 days after KOMZIFTI initiation. The median time to onset was 15 days. Two patients experienced more than one DS event. Treatment was interrupted and resumed in 15 (13%) patients, while it was permanently discontinued in 2 (2%) patients.

Prior to starting treatment with KOMZIFTI, reduce the WBC counts to less than 25 x 10⁹/L. If DS is suspected, interrupt KOMZIFTI, initiate oral or intravenous corticosteroids (e.g., dexamethasone 10 mg every 12 hours) for a minimum of 3 days with hemodynamic and laboratory monitoring. Resume treatment with KOMZIFTI at the same dose level when signs and symptoms improve and are Grade 2 or lower. Taper corticosteroids over a minimum of 3 days after adequate control or resolution of symptoms. Symptoms of DS may recur with premature discontinuation of corticosteroid treatment.

QTc Interval Prolongation

KOMZIFTI can cause QTc interval prolongation. In the clinical trial, QTc interval prolongation was reported as an adverse reaction in 12% of 112 patients treated with KOMZIFTI at the recommended dosage for R/R AML with an NPM1 mutation. QTc interval prolongation was Grade 3 in 8% of patients. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 9% of patients, and the increase from baseline QTcF was greater than 60 msec in 12% of patients. KOMZIFTI dose reduction was required for 1% of patients due to QTc interval prolongation. QTc prolongation occurred in 14% of the 42 patients less than 65 years of age and in 10% of the 70 patients 65 years of age or older.

Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to treatment with KOMZIFTI. Perform an ECG prior to initiation of treatment with KOMZIFTI, and do not initiate KOMZIFTI in patients with QTcF > 480 msec. Perform an ECG at least once weekly for the first four weeks on treatment, and at least monthly thereafter. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms (Grade 3). In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use of KOMZIFTI with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation, result in a greater increase in the QTc interval and adverse reactions associated with QTc interval prolongation, including Torsades de Pointes, other serious arrhythmias, and sudden death.

Embryo-Fetal Toxicity

Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 3 months after the last dose.

ADVERSE REACTIONS

Fatal adverse reactions occurred in 4 (4%) patients who received KOMZIFTI, including 2 with differentiation syndrome, 1 with infection, and 1 with sudden death. Serious adverse reactions were reported in 79% of patients who received KOMZIFTI. Serious adverse reactions occurring in ≥ 5% of patients included infection without an identified pathogen (29%), febrile neutropenia (18%), bacterial infection (16%), differentiation syndrome (16%), and dyspnea (6%).

Dosage interruption of KOMZIFTI due to an adverse reaction occurred in 54% of patients. Adverse reactions that required dose interruption in ≥ 2% of patients included infection without an identified pathogen (15%), differentiation syndrome (13%), febrile neutropenia (5%), pyrexia (4%), electrocardiogram QT prolonged (4%), leukocytosis (4%), bacterial infection (3%), cardiac failure (2%), cholecystitis (2%), diarrhea (2%), pruritus (2%), and thrombosis (2%). Dose reduction of KOMZIFTI due to an adverse reaction occurred in 4% of patients. Permanent discontinuation of KOMZIFTI due to an adverse reaction occurred in 21% of patients. Adverse reactions that required permanent discontinuation of KOMZIFTI in ≥ 2% of patients were infection without an identified pathogen (8%), bacterial infection (4%), cardiac arrest (2%), and differentiation syndrome (2%).

Most common (≥ 20%) adverse reactions, including laboratory abnormalities, were aspartate aminotransferase increased (53%), infection without an identified pathogen (52%), potassium decreased (52%), albumin decreased (51%), alanine aminotransferase increased (50%), sodium decreased (49%), creatinine increased (45%), alkaline phosphatase increased (41%), hemorrhage (38%), diarrhea (36%), nausea (35%), fatigue (34%), edema (30%), bacterial infection (28%), musculoskeletal pain (28%), bilirubin increased (27%), potassium increased (26%), differentiation syndrome (26%), pruritus (23%), febrile neutropenia (22%), and transaminases increased (21%).

DRUG INTERACTIONS

Drug interactions may occur when KOMZIFTI is concomitantly used with:

Strong or Moderate CYP3A4 Inhibitors: Monitor patients more frequently for KOMZIFTI-associated adverse reactions.
Strong or Moderate CYP3A4 Inducers: Avoid concomitant use of KOMZIFTI.
Gastric Acid Reducing Agents: Avoid concomitant use of KOMZIFTI with proton pump inhibitors (PPIs), H2 receptor antagonists (H2RAs), or locally acting antacids. If concomitant use with H2RAs or locally acting antacids cannot be avoided, modify KOMZIFTI administration time.
Take KOMZIFTI 2 hours before or 10 hours after administration of an H2 receptor antagonist.
Take KOMZIFTI 2 hours before or 2 hours after administration of a locally acting antacid.
Drugs that Prolong the QTc Interval: Avoid concomitant use of KOMZIFTI. If concomitant use cannot be avoided, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms.
USE IN SPECIFIC POPULATIONS

Pregnancy: Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to starting KOMZIFTI.

Lactation: Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with KOMZIFTI and for 2 weeks after the last dose.

Infertility: Based on findings in animals, KOMZIFTI may impair fertility in females and males of reproductive potential.

Please see full Prescribing Information, including Boxed WARNING.

NPM1, nucleophosmin 1, KMT2A, lysine methyltransferase 2A, FLT3, Fms-like tyrosine kinase 3

(Press release, Kura Oncology, NOV 13, 2025, View Source [SID1234659903])

On November 13, 2025 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, reported its third quarter 2025 financial results and provided a corporate update.

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Recent Highlights:

In September, ImmuneOnco, Instil’s collaborator, presented updated data from additional patients with relapsed/refractory squamous non-small cell lung cancer treated with ‘2510 as monotherapy in a poster presentation at the 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer.
In October, Axion Bio, Instil’s subsidiary, dosed the first patient in its Phase 1 clinical trial of ‘2510 as monotherapy in patients with relapsed or refractory solid tumors.
Third Quarter 2025 Financial and Operating Results:

As of September 30, 2025, Instil had cash, cash equivalents, restricted cash, marketable securities and long-term investments of $83.4 million, which consisted of $5.8 million in cash and cash equivalents, $0.3 million in restricted cash, $73.9 million in marketable securities, and $3.4 million in long-term investments, compared to $115.1 million in cash, cash equivalents, restricted cash and marketable securities as of December 31, 2024, consisting of $8.8 million in cash and cash equivalents, $1.8 million in restricted cash, and $104.5 million in marketable securities. Instil expects that its cash, cash equivalents, restricted cash, marketable securities and long-term investments as of September 30, 2025 will enable it to fund its operating plan beyond 2026.

In-process research and development expenses were nil and $10.0 million for the three and nine months ended September 30, 2025, respectively, compared to $10.0 million for both the three and nine months ended September 30, 2024.

Research and development expenses were $9.1 million and $21.2 million for the three and nine months ended September 30, 2025, respectively, compared to $0.6 million and $10.7 million for the three and nine months ended September 30, 2024, respectively.

General and administrative expenses were $5.9 million and $21.2 million for the three and nine months ended September 30, 2025, respectively, compared to $10.7 million and $33.8 million for the three and nine months ended September 30, 2024, respectively.

Restructuring and impairment charges were nil and $16.6 million for the three and nine months ended September 30, 2025, respectively, compared to $2.4 million and $7.1 million for three and nine months ended September 30, 2024, respectively.

Net loss per share, basic and diluted were $2.01 and $9.53 for the three and nine months ended September 30, 2025, respectively, compared to $3.54 and $9.57 for the three and nine months ended September 30, 2024, respectively. Non-GAAP net loss per share, basic and diluted, were $1.75 and $5.95 for the three and nine months ended September 30, 2025, respectively, compared to $2.55 and $6.51 for the three and nine months ended September 30, 2024, 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.

(Press release, Instil Bio, NOV 13, 2025, View Source [SID1234659902])

On November 13, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its business update and financial results for the first nine months of 2025.

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"This quarter highlights strong execution across our key programs," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. "With FDA clearance to initiate TELLOMAK-3, we are advancing lacutamab toward its confirmatory Phase 3 and potential accelerated approval in Sézary syndrome. We remain on track for dose-escalation data, from IPH4502, our Nectin-4 ADC, in the first half of 2026, followed by monalizumab PACIFIC-9 results in the second half of 2026. Together, these milestones position us well to deliver meaningful value for patients and shareholders as we continue to advance our differentiated portfolio."

Including short term investments (€6.1 million) and non-current financial instruments (€10.4 million).

Webcast and conference call will be held today at 2:00pm CET (8:00am ET)

The live webcast will be available at the following link:
View Source

Analysts may also join via telephone, click here to register: View Source

This information can also be found on the Investors section of the Innate Pharma website,
www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.

*****

Pipeline highlights:

Strategic focus

As previously announced, Innate Pharma is prioritizing its investment on what it believes are its highest-value clinical assets, IPH4502, lacutamab, and monalizumab (partnered with AstraZeneca); and advancing the next Antibody Drug Conjugates (ADCs) toward development, leveraging its pipeline of innovative targets.

Lacutamab (anti-KIR3DL2 antibody):

Cutaneous T Cell Lymphoma

•The Company announced on November 10 that the U.S. Food and Drug Administration (FDA) has completed its review of the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas (CTCL), with no further comments, clearing the trial to proceed.

•The planned confirmatory Phase 3 trial, TELLOMAK-3, is an open-label, randomized study designed to demonstrate the efficacy of lacutamab in patients with Sézary syndrome and Mycosis fungoides, who failed at least one prior line of systemic therapy. The trial will include two independent cohorts: one enrolling patients with Sézary syndrome post-mogamulizumab treatment randomized 1:1 to receive lacutamab or romidepsin, and one enrolling patients with Mycosis fungoides randomized 1:1 to receive lacutamab or mogamulizumab. The primary endpoint of the study for both cohorts is progression-free survival (PFS) evaluated by blinded central review.

•Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. With this feedback from FDA, the Company is progressing towards the initiation of the confirmatory Phase 3 TELLOMAK-3 trial in H1 2026. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome, once the Phase 3 trial is underway.

•The Company held a KOL event on October 28, 2025 on lacutamab and provided updates on the planned Phase 3 trial, the regulatory pathway in CTCL, and the commercial opportunity for lacutamab.

Peripheral T Cell lymphoma (PTCL)

•The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an investigator-sponsored, randomized controlled trial led by the Lymphoma Study Association (LYSA) to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL is ongoing and continues to recruit patients.

IPH4502 (Nectin-4 exatecan ADC):

•The Phase 1 trial will assess the safety, tolerability, and preliminary efficacy of IPH4502 in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers. The study plans to enroll approximately 105 patients.

•The first patient was dosed in the Phase 1 study in January 2025. Enrollment of the dose escalation part continues to progress well and is expected to be completed at the end of 2025 or in the first quarter of 2026. Pharmacologically active dose has been reached.

Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

•The Phase 3 PACIFIC-9 trial run by AstraZeneca evaluating durvalumab (anti-PD‑L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT) is ongoing. Enrollment in the trial is complete, and data readouts are expected in H2 2026.

Other Clinical stage assets

IPH6501 (ANKET anti-CD20 with IL-2V, proprietary): The Phase 1/2 clinical trial is evaluating IPH6501 in B-cell Non-Hodgkin’s lymphoma (B-NHL). The study is planned to enroll up to 184 patients. Clinical sites are open in the US, Australia, and France. Enrollment in the dose escalation phase of the trial is complete. Clinical data are expected to be presented in 2026.

IPH6101 (ANKET anti-CD123, proprietary): Innate regained the rights to SAR’579/IPH6101 in July 2025. Data from the Sanofi-led Phase 1/2 study and Phase 2 preliminary dose expansion of the trial have been transferred to Innate and the Company is evaluating potential next steps.

IPH5201 (anti-CD39 antibody, partnered with AstraZeneca): The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201, an anti CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, is ongoing, and recruitment is on track.

IPH5301 (anti-CD73, proprietary): The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing.

Corporate update

•As previously announced, in line with its strategic focus, the Company intends to streamline its organization. Planned layoffs will be implemented through a redundancy plan, expected to be completed during the first half of 2026. A consultation with the Workers’ Council is ongoing and the plan is subject to endorsement by the French authorities (Dreets).

•The ATM program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million of American Depositary Shares ("ADS") is still in place. As of September 30, 2025, no sales have been made under the program.

Financial Results

Cash, cash equivalents and financial assets of the Company amounted to €56.4 million as of September 30, 2025. At the same date, financial liabilities amounted to €24.8 million.

Revenues for the first nine months of 2025 amounted to €2.3 million (€10.2 million for the same period in 2024). For the nine-month period, ended September 30, 2025, revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi.

(Press release, Innate Pharma, NOV 13, 2025, View Source [SID1234659901])

On November 13, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported financial results for the three-month and nine-month periods ended September 30, 2025, and highlighted recent business updates, including progress in advancing Phase 3 clinical development of its lead candidate IMNN-001 in newly diagnosed advanced ovarian cancer.

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"IMUNON is rapidly advancing a potential breakthrough for women with newly diagnosed advanced ovarian cancer—a disease with no meaningful frontline treatment progress in decades," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "Strong Phase 2 OVATION 2 survival data, reinforced by compelling interim results from our MRD study and a clear regulatory path in Phase 3, position IMNN-001 to deliver transformative impact."

"Our clinical success has attracted increasing interest from the medical community and potential partners. As we advance the Phase 3 OVATION 3 Study, which is evaluating IMNN-001 in women with stage IIIC or IV ovarian cancer, we are committed to funding this pivotal trial strategically. We have taken steps to conserve cash and align our critical needs with available capital on hand, while securing the resources needed to advance this potentially transformative therapy with select financing opportunities," Dr. Lindborg continued.

RECENT DEVELOPMENTS

IMNN-001 Immunotherapy

R&D Day Highlighting Progress on OVATION 3 Study in Pursuit of First Frontline Immunotherapy for Advanced Ovarian Cancer – On November 10, 2025, the Company hosted an R&D Day, providing updates on new IMNN-001 data and discussing progress with the OVATION 3 Study and IMNN-001’s potential role in transforming the treatment landscape for women with advanced ovarian cancer. The event featured ovarian cancer thought leaders, principal investigators from the Company’s Phase 3 OVATION 3 Study and Phase 2 minimal residual disease (MRD) clinical trial (conducted in partnership with Break Through Cancer Foundation), and statistical experts.

R&D Day Featured Speakers and Program Highlights:

Premal H. Thaker, M.D., Washington University School of Medicine, discussed the significant continuing unmet needs in ovarian cancer, a devastating disease where patient outcomes and frontline standard of care treatment have not changed for about 30 years, and the promise IMNN-001 brings to these patients and clinicians. She also highlighted the data from the Phase 2 OVATION 2 clinical trial, with results including:
Broad impact observed with IMNN-001 treatment on important cancer-fighting cytokines, effectively turning the tumor microenvironment from "cold" to "hot" by activating both innate and adaptive immune systems, renewing the elusive promise of an immunotherapy for ovarian cancer.
Data reinforcing the highly favorable benefit-risk and safety profile of IMMN 001.
The remarkable median 13-month overall survival (OS) benefit observed with IMNN-001 plus standard of care (SoC) chemotherapy, an increase that is considered clinically meaningful compared to SoC alone.
Amir Jazaeri, M.D., University of Texas MD Anderson Cancer Center, discussed safety, tolerability and translational insights from the Phase 2 MRD study of IMNN-001, including:
Rationale for the trial and the importance of frontline therapy as the best opportunity to achieve a cure for ovarian cancer.
New translational data that shows IMNN-001 preferentially being taken up by macrophages within the peritoneal fluid and tumor tissue, which then induces a robust response and tumor microenvironment remodeling.
New data supporting the highly favorable benefit-risk and tolerability profile of IMNN-001.
The positive tolerability profile of IMNN-001, including in combination with SoC chemotherapy plus bevacizumab, and in the maintenance setting.

Giorgio Paulon, Ph.D., Berry Consultants, LLC, reviewed the Phase 2 and ongoing Phase 3 trial designs, and the strength of evidence for IMNN-001 from a statistical perspective. He highlighted the well-precedented nature of the Phase 3 design with the FDA, which leverages an innovative, adaptive, event-driven approach aligned with prior successful oncology trials that resulted in full approval by FDA based on an interim analysis of overall survival. This foundation, supported by conservative power assumptions drawn from Phase 2 data, strong simulation modeling and robust statistical properties, underpins the Phase 3 trial’s high probability for success.

Douglas V. Faller, M.D., Ph.D., IMUNON, shared new data further demonstrating IMNN-001 shifted the balance in favor of immune stimulation, remodeling the tumor microenvironment in favor of anti-tumor responses, which is established to be associated with better prognosis. He shared the rapid progress to-date on the Phase 3 trial of IMNN-001, including expansion to additional sites and enrollment exceeding the Company’s expectations, strong levels of support and interest from investigators and the scientific community, and key clinical and other milestones for the company moving forward.
The presentations from the R&D Day are available on the "Scientific Presentations" page of the IMUNON’s website at View Source

IMUNON Presents Translational Data from Phase 2 OVATION 2 Study of IMNN-001 at SITC (Free SITC Whitepaper) 40th Annual Meeting – On November 7, 2025, the Company presented translational data from the Phase 2 OVATION 2 clinical trial of IMNN-001 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, held on November 5-9, 2025 in National Harbor, Maryland.

The new data from recently analyzed OVATION 2 samples demonstrated that IMNN-001 creates a "hot" anti-tumor microenvironment in epithelial ovarian cancer by (i) increasing the recruitment of anti-tumor CD8+, myeloid dendritic cells and M1 macrophages in patient tumors; and (ii) decreasing immunosuppressive markers (IDO, Treg, exhausted CD8, M2 macrophages). These results, including induction of favorable ratios of CD8+/Tregs and CD8+/CD4+ cells, which are both associated with improved patient outcomes, are consistent with the results of the previous OVATION 1 study and with the efficacy seen in the clinic in the OVATION 2 study. This biomarker research confirms local immune activation at the tumor site by IMNN-001.

The poster presentation is available on the "Scientific Presentations" page of the IMUNON’s website at View Source

IMUNON Presents Phase 3 OVATION 3 Study of IMNN-001 in Advanced Ovarian Cancer at the ESMO (Free ESMO Whitepaper) Congress and the IGCS 2025 Annual Global Meeting – On October 14, 2025, the Company announced that a trials-in-progress abstract on the ongoing Phase 3 OVATION 3 clinical trial of IMNN-001 was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, held on October 17-21, 2025 in Berlin, Germany with an encore presentation following the 2025 Annual Global Meeting of the International Gynecologic Cancer Society (IGCS), held on November 5-7, 2025, in Cape Town, South Africa. The poster presentations are available on the "Scientific Presentations" page of the IMUNON’s website at View Source

Positive Translational Data of IMNN-001 Presented at AACR (Free AACR Whitepaper) Special Conference in Cancer Research Demonstrating 13 Month OS Extension via Tumor Micro-Environment Shift – On September 22, 2025, the Company presented positive translational data from the Phase 2 OVATION 2 Study of IMNN-001 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference in Cancer Research: Advances in Ovarian Cancer Research, held on September 19-21, 2025, in Denver, Colorado reinforcing the favorable safety profile and efficacy benefits of IMNN-001 observed in the clinic, including increases in key anti-cancer immune cytokines and modulation of relevant anti-tumor immune cell populations, such as CD8+ T cells and myeloid dendritic cells, in the tumor and tumor microenvironment in study participants post-treatment.

IMUNON reviewed translational data on the changes induced by the local administration of IL-12 and its downstream effectors in the tumor micro-environment (TME) from paired samples (pre- and post-treatment) from study participants. Results presented at the AACR (Free AACR Whitepaper) Special Conference demonstrated:

Positive shift in the local TME to favorable immune stimulatory T cell ratios in the majority of participants treated with IMNN-001, including favorable ratios of CD8+/T regulatory (Treg) cells, CD8+/IDO+ cells, and CD8+/CD4+ cells.
TME shift in favor of decreased immunosuppression cells (IDO+, PDL1+, Treg, CD4+) and increased immunostimulatory cells (CD8+, CD8+ effector, myeloid dendritic cells) in the majority of participants post-treatment.
IMNN-001 treatment creates a "hot" anti-TME by increasing the recruitment of anti-tumor CD8+ and myeloid dendritic cells in 50-80% of the paired samples and decreasing immunosuppressive markers (IDO, PDL1, Treg cells) in 65-80% of the samples.
Results from the study continue to validate our TheraPlas technology and the broad impact of IMNN-001 on important cancer-fighting cytokines, effectively turning the tumor microenvironment from "cold" to ‘hot’ by activating both innate and adaptive immune systems, with limited to no systemic toxicities. IMNN-001 has shown significant therapeutic potential in clinical trials thus far, and the robust survival benefits and favorable safety profile observed align with these translational findings, supporting the ongoing Phase 3 OVATION 3 trial.

The OVATION 2 Study poster presentation is available on the "Scientific Presentations" page of IMUNON’s website at View Source.

PlaCCine DNA Vaccine Technology

PlaCCine DNA Technology Proof-of-Concept Data Presented in Platform Presentations at Leading Vaccine Conferences – On October 17, 2025, the Company announced that members of its leadership team will deliver oral presentations highlighting IMNN-101, its investigational DNA plasmid vaccine based on the Company’s proprietary PlaCCine technology platform, including proof-of-concept clinical trial results at the following vaccine conferences:

5th Edition of International Vaccines Congress (IVC) Keynote Oral Presentation Title: A promising novel approach to DNA vaccines, on October 23 2025 and
10th International Conference on Vaccine Research and Development Oral Presentation Title: Development of a PlaCCine DNA Technology for Safe, Effective and Durable Vaccines, on November 6, 2025
These presentations described the unique design and composition of the PlaCCine technology and its differentiating features including a longer duration of antigen expression, safety, user compliance and storage stability at workable temperatures (up to one year at 4°C and one month at 37°C) in comparison to mRNA vaccines and other DNA vaccines requiring viruses or devices for delivery. The immunogenicity of the PlaCCine technology was demonstrated against various pathogens in multiple species and animal models. These presentations also demonstrated safety and immunogenicity of a PlaCCine vaccine targeting a SARS-CoV-2 spike variant in healthy human participants following intramuscular administration. Durable NAb responses to 6 months demonstrating vaccine immunogenicity following a single dose in previously vaccinated or infected individuals with the SARS-CoV-2 underscore the significance of the PlaCCine approach and support continued development in both naive populations using a prime and boost vaccination to determine optimal benefits and in other infectious diseases.

IMNN-101 has been shown to be safe and well tolerated, with no serious adverse effects reported. To accelerate the development and commercialization of the PlaCCine platform, IMUNON is actively seeking strategic partnerships with leading pharmaceutical and biotechnology companies. These collaborations aim to leverage PlaCCine’s unique advantages—enhanced durability, temperature stability, and scalable manufacturing—to address unmet needs in vaccines for infectious diseases and cancer, while securing non-dilutive funding to advance IMUNON’s broader oncology focused pipeline

THIRD QUARTER 2025 FINANCIAL RESULTS

Net loss for the third quarter of 2025 was $3.4 million, or $1.16 per share, compared with a net loss of $4.8 million, or $3.76 per share, for the third quarter of 2024. Operating expenses were $3.5 million for the third quarter of 2025, a decrease of $1.5 million or 30% from $5.0 million for the third quarter of 2024.

Research and development (R&D) expenses were $1.9 million for the third quarter of 2025, a decrease of $1.4 million from $3.3 million for the third quarter of 2024. The decrease was due primarily to lower costs associated with the OVATION 2 Study, the Phase 1 proof-of-concept PlaCCine DNA vaccine trial, and development of the PlaCCine DNA vaccine technology platform.

General and administrative (G&A) expenses were $1.6 million for the third quarter of 2025, compared with $1.7 million for the third quarter of 2024. This decrease was primarily attributable to lower employee-related expenses.

Investment income from short-term investments was $47,000 for the third quarter of 2025 compared to $116,000 for the same period in 2024 due to lower cash balances.

As of September 30, 2025, cash and cash equivalents were $5.3 million. During the third quarter of 2025, the Company received $4.5 million in net proceeds from the exercise of warrants and sales under its ATM facility. The Company believes it has sufficient capital resources to fund its planned operations into the first quarter of 2026.

NINE MONTHS ENDED SEPTEMBER 30, 2025 FINANCIAL RESULTS

For the nine months ended September 30, 2025, the Company reported a net loss of $10.3 million, or $5.53 per share, compared with a net loss of $14.6 million, or $14.13 per share, for the same nine-month period of 2024. Operating expenses were $10.4 million for the nine months ended September 30, 2025, a decrease of $4.6 million or 31% from $15.0 million for the same period in 2024.

Net cash used for operating activities was $10.2 million for the first nine months of 2025, compared with $14.4 million for the same period in 2024. This decrease was due to lower operating costs.

R&D expenses were $5.3 million in the first nine months of 2025, compared with $9.4 million in the same period of 2024. Clinical costs associated with the OVATION 2 and MRD trials were $0.2 million in the first nine months of 2025 compared to $1.1 million in the same period of 2024. Clinical costs associated with the OVATION 3 trial were $0.7 million in the first nine months of 2025. Clinical costs associated with the PlaCCine vaccine trial were $42,000 in the first nine months of 2025 compared to $1.4 million in the first nine months of 2024. Other clinical and regulatory costs were $1.4 million in the first nine months of 2025 compared to $1.9 million in the same period of 2024. R&D costs associated with the development of IMNN-001 to support the OVATION program were $2.2 million in the first nine months of 2025 compared to $0.9 million in same period of 2024. The cost of development of the PLACCINE DNA vaccine technology platform was $2.5 million in the first nine months of 2024. CMC costs were $0.7 million in the first nine months of 2025 compared to $1.6 million in the same period of 2024.

G&A expenses were $5.1 million in the first nine months of 2025, compared with $5.6 million in the same period of 2024. The decrease was primarily attributable to lower employee-related and professional service expenses and lower travel expenses.

Investment income was $117,000 in the first nine months of 2025, compared with $423,000 in the same period of 2024. This decrease is due to lower cash and investment balances.

Please note: All share and per share amounts in this press release have been adjusted to reflect a 15-for-1 reverse split of our common stock (which we effected on July 25, 2025) and all per share amounts in this press release have been adjusted for the 15% stock dividend (which we announced on July 28, 2025).

Conference Call and Webcast

The Company is hosting a conference call to review third quarter 2025 financial results and provide a business update today, November 13, 2025, at 11:00 a.m. ET. To participate in the call, please dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON Third Quarter 2025 Financial Results Call. A live webcast of the call will also be available here.

The call will be archived for replay until November 27, 2025, and can be accessed at 877-344-7529 (U.S. Toll Free), 855-669-9658 (Canada Toll Free) or 412-317-0088 (International Toll) using replay access code 4592282. An audio replay of the call will also be available here for 90 days.

(Press release, IMUNON, NOV 13, 2025, View Source [SID1234659900])

On November 13, 2025 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, reported financial results for the third quarter ended September 30, 2025, and provided a business update.

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"The potentially transformative impact of FT819 in lupus is at an inflection point as we enter the final quarter of the year with accelerated advancements in our autoimmune and oncology programs," said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. "The meaningful therapeutic and favorable safety profile of FT819 seen to date in preliminary clinical data combined with its broad patient accessibility demonstrates that CAR T-cell therapy can be delivered in a community setting, broadening reach for a wide range of patients with limited treatment options. Our focus remains on driving enrollment and expanding access for patients with lupus and other autoimmune diseases as we advance toward our planned registration study in 2026. In parallel, we continue to strengthen our iPSC platform and next-generation CAR T-cell programs, leveraging our Sword and Shield technology to expand the reach of off-the-shelf cell therapies, including FT836 with its unique ability to target a broad array of cancers. Operationally, we remain disciplined, with a well-capitalized balance sheet that is intended to fund the company’s operations through 2027."

R&D Highlights and Updates

FT819 Off-the-Shelf CAR T-cell Program in Autoimmune Disease for Broad Patient Accessibility

FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product engineered to improve safety and efficacy. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master iPSC line serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to potentially reach a broad patient population.

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Authorization received from Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) to initiate clinical trials of FT819. Fate Therapeutics has now received regulatory clearance from the United Kingdom (UK) MHRA to proceed with clinical evaluation of FT819 in autoimmune diseases. This authorization represents a significant step in the Company’s international expansion and highlights global interest in the unique ability of FT819 to enable broad patient accessibility of CAR T cells without the requirement of intensive conditioning. The first of several planned UK clinical sites is now active and open to patient enrollment. The Company also received regulatory authorization from the European Union (EU) EMA to initiate the FT819 clinical trial across multiple EU countries.

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Data presented at American College of Rheumatology (ACR) Convergence 2025 continues to demonstrate robust clinical activity with preferable tolerability; translational data demonstrates sustained B-cell depletion and immune remodeling after treatment with FT819. The Company presented new data demonstrating encouraging enrollment in its ongoing clinical study, reflecting growing physician and patient interest in FT819 for autoimmune diseases. The preliminary clinical data highlighted robust activity in patient responses, and favorable tolerability, reinforcing the potential of FT819 as a transformative therapy for lupus and other autoimmune disorders. Data was presented across both regimens: (i) Regimen A, with either bendamustine alone or cyclophosphamide alone, followed by a single FT819 dose, and (ii) Regimen B, no chemotherapy conditioning, with a single FT819 dose given in combination with stable maintenance standard of care.
Updated Phase 1 data were presented for 10 patients with treatment-refractory, moderate-to-severe Systemic Lupus Erythematosus (SLE) treated with a single dose of FT819 with less-intensive or no conditioning chemotherapy. The overall data, for which 8 patients had completed greater than one month of follow-up, showed meaningful reductions in disease activity and improvements in fatigue and physician assessments across both regimens. As of a September 25, 2025 data cut-off-date, three patients with ≥ 3 months follow up on Regimen A demonstrated a significant mean SLEDAI-2K score decrease of 10.7 points at 3 months and 14 points at 6 months; while the one Regimen B patient with ≥ 3 months follow up had their SLEDAI-2K score decrease by 6 points. Both Regimen A patients with active lupus nephritis who had ≥ 6 months follow up on Regimen A demonstrated renal responses, marked by decreases in their UPCR to < 0.5 mg/mg. Most notably, the lupus nephritis patient with the longest follow up of 15 months (Regimen A, dose level 1) achieved a 16-point SLEDAI-2K score reduction from baseline, discontinued steroids and maintained both DORIS (definition of remission in SLE) and complete renal response (CRR). Furthermore, depletion and reconstitution of B cells after treatment with FT819 in Regimen A continued to demonstrate successful remodeling of the immune system with the effective depletion of pathogenic B cells and the recovery of naïve subtypes. Importantly, FT819 was well tolerated with no dose limiting toxicities, no immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GvHD), and only low-grade incidences of cytokine release syndrome (CRS), supporting its potential as a broadly accessible treatment without over-night hospitalization.

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First systemic sclerosis (SSc) patient treated in Phase 1 autoimmunity study. The multi-center, Phase 1 clinical trial is designed to evaluate the safety, pharmacokinetics, and anti-B-cell activity of FT819 in four autoimmune diseases, including with less-intensive or no conditioning chemotherapy: systemic lupus erythematosus (SLE), systemic sclerosis (SSc), antineutrophil cytoplasmic antibody-associated vasculitis (AAV), and idiopathic inflammatory myositis (IIM) (NCT06308978). For SSc, the prevalence is greater than 85,000 patients in the US with significant unmet medical need, as currently, there are no existing cures or single disease modifying treatments to stop or reverse overall progression of disease. The first patient, a 31-year-old woman diagnosed with SSc six years ago who has refractory disease, despite having been treated with multiple standard of care therapies, received fludarabine-free conditioning followed by a single dose of FT819 at 900 million cells. The patient was discharged after a three-day hospital stay without any notable adverse events.
FT825 / ONO-8250 Off-the-Shelf CAR T-cell Program in Solid Tumors

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Phase 1 study ongoing for advanced solid tumors. Under the collaboration with Ono Pharmaceutical Co., Ltd. (Ono), the Company is conducting a multi-center, Phase 1 study evaluating FT825 / ONO-8250, a multiplex-engineered CAR T-cell candidate targeting HER2, in patients with advanced solid tumors (NCT06241456). Dose escalation is ongoing at the third dose level of 900 million cells, with each patient receiving conditioning chemotherapy followed by a single dose of FT825 / ONO-8250, administered either as monotherapy or in combination with EGFR-targeted monoclonal antibody therapy. Notably, HER2 expression is now confirmed by biopsy to ensure patient eligibility and appropriate stratification to treatment arms. As of a September 22, 2025 data cut-off, nine patients have been treated in the monotherapy arm and seven patients in the combination arm. Through the data cut-off date, FT825 / ONO-8250 continues to demonstrate a favorable tolerability with no dose-limiting toxicities (DLTs) observed, supporting ongoing dose escalation in late-stage patients. Further evaluation will focus on cohorts of patients with confirmed high levels of HER2 expression in advanced solid tumors, and as warranted into earlier lines of therapy in combination with standard of care treatment.
Next-generation Off-the-Shelf CAR T-cell Programs with Novel Sword & Shield Technology Designed to Eliminate the Need for Conditioning Chemotherapy

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First solid tumor patient treated in a Phase 1 basket trial for FT836 MICA/B-targeted CAR T-cell program. FT836 is a multiplex-engineered CAR T-cell product candidate uniquely targeting major histocompatibility complex (MHC) proteins A (MICA) and B (MICB) which are expressed on many types of cancer cells with limited detection on healthy tissue. Accordingly, a Phase 1 study was designed to assess the safety and activity of FT836 without administration of conditioning chemotherapy for the treatment of advanced solid tumors (NCT07216105). The first patient, a 47-year-old male with stage IV colorectal cancer (CRC) with five prior lines of systemic therapy, was treated with FT836 at 300 million cells in the cetuximab combination arm without any conditioning chemotherapy. The patient was discharged after a one-day hospital stay without any notable adverse events and is expected to be treated with a second dose of FT836 at 300 million cells on Day 15 of the treatment cycle. In parallel, non-clinical datasets underscoring broad solid tumor indication applicability, in combination with multi-antigen targeting, augmented tumor micro-environment adaptation, enhanced allo-protection via Sword and ShieldTM technology, and ability of FT836 to be administered in the absence of conditioning chemotherapy were recently presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2025). The Company plans to present a complimentary dataset establishing the utility of FT836 against multiple myeloma in combination with daratumumab and/or standard of care therapy at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The development of FT836 is supported by a $4 million award from the California Institute of Regenerative Medicine (CIRM).
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Commencement of Investigational New Drug (IND) application enabling activities for FT839 dual-CAR T-cell program. FT839 is a multiplex-engineered dual CAR T-cell product candidate that co-targets CD19 and CD38 and is designed to eliminate an array of aberrant immune cells contributing to both autoimmunity and hematological malignancies. The Company has previously presented preclinical data demonstrating robust eradication of aberrant CD19+ B cells, CD38+ plasma cells, CD38+ activated T cells, and hematological cancer cell lines by FT839 in completely mismatched allogeneic environments, demonstrating the potential versality of the dual-CAR approach combined with its Sword and ShieldTM technology. At the upcoming ASH (Free ASH Whitepaper) Annual Meeting, the Company intends to present updated pre-clinical datasets further supporting multi-disease therapy potential. The Company has now generated a master iPSC bank for conducting IND-enabling studies and is currently evaluating opportunities for clinical investigation of FT839 in hematological malignancies and autoimmune disease in 2026.

Other Corporate Updates

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Kamal Adawi, M.S., M.B.A., appointed to the role of Chief Financial Officer. Mr. Adawi brings to the Company more than 20 years of financial leadership experience in the life sciences industry, including over 10 years serving as CFO across innovative life science companies, with deep domain expertise in autoimmune diseases, including lupus.

Third Quarter 2025 Financial Results

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Cash & Investment Position: Cash, cash equivalents, and investments as of September 30, 2025 were $225.7 million.
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Total Revenue: Revenue was $1.7 million for the third quarter of 2025, which was derived from the conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under the Company’s collaboration with Ono Pharmaceutical.
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Total Operating Expenses: Total operating expenses were $36.5 million for the third quarter of 2025, including research and development expenses of $25.8 million and general and administrative expenses of $10.6 million. Such amount included $4.9 million of non-cash stock-based compensation expense.
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Shares Outstanding: As of September 30, 2025, common shares outstanding were 115.3 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million. Each preferred share is convertible into five common shares.

About Fate Therapeutics’ iPSC Product Platform

Human induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be administered in combination with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with patient- and donor-sourced cell therapies. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications.

(Press release, Fate Therapeutics, NOV 13, 2025, View Source [SID1234659899])