On November 5, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a precision guided, biotech/life sciences company focused on advancing novel and potentially disruptive therapeutic assets, reported that it will be presenting at BIO-Europe 2026, being held on November 9-11, 2026, in Cologne, Germany.

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Dr. Faisal Mehmud, Chief Medical Officer of Medicus, presentation will highlight the Company’s progress around precision oncology, anchored by CD228V, an investigational antibody-drug conjugate (ADC) molecule utilizing an established vedotin linker-payload platform, as well as SkinJect, an investigational localized immuno-oncology precision product, for multiple basal cell carcinoma lesions in patients with Gorlin syndrome, a rare autosomal dominant genetic disease. The presentation will also cover development and partnership outlook for the Teverelix Program.

Presentation details:

Date: Monday, November 9, 2026
Time: 9:15 to 9:30 a.m. CET
Location: Theatre B, Koelnmesse, Cologne, Germany
Dr. Mehmud will be available to hold one-on-one meetings with institutional investors and prospective partners throughout the conference. The full BIO-Europe 2026 agenda is available on the conference website.

Advancing a Focused Precision Oncology Portfolio

CD228V is an early clinical-stage ADC, utilizing Pfizer’s established vedotin linker-payload platform. Medicus is prioritizing clinical proof-of-concept in melanoma, particularly relapsed, refractory or immunotherapy-resistant disease, with biomarker research intended to guide further development. The Company believes that evidence generated in melanoma could support evaluation in additional CD228-expressing solid tumors.

Medicus aims to build clinical evidence in defined patient populations while pursuing partnerships that can contribute expertise and development resources.

(Press release, Medicus Pharma, NOV 5, 2026, View Source [SID1234674317])

On November 5, 2026 Johnson & Johnson (NYSE: JNJ) reported that the U.S. Food and Drug Administration (FDA) granted accelerated approval for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) (subcutaneous injection, 160 mg/2,000 units per mL) as a single agent for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum‑based chemotherapy and an anti‑PD‑(L)1 antibody. The indication does not include patients with oropharyngeal squamous cell carcinoma (OPSCC) that is HPV-associated (i.e., by p16 immunohistochemistry). It is the first approval of a dual-targeted therapy in this setting, simultaneously targeting epidermal growth factor receptor (EGFR)- and mesenchymal-epithelial transition (MET).2-3

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Today’s approval follows the FDA Breakthrough Therapy Designation (BTD) granted in February 2026 and Priority Review designation in July 2026. This indication was granted accelerated approval based on clinically meaningful and durable tumor response demonstrated in the Phase 1b/2 OrigAMI-4 trial.1

Overall Response Rate (ORR): Confirmed ORR was 42 percent (95 percent confidence interval [CI], 32–52 percent), including complete responses in 15 percent of patients, representing one-third of all responders, and partial responses in 28 percent of patients, per blinded independent central review (BICR).
Duration of Response (DOR): 56 percent of responders maintained a response for more than six months (1.4+, 19.7+), per BICR.
Continued approval may be contingent upon verification and description of clinical benefit in the ongoing confirmatory trial in first-line HNSCC, the Phase 3 OrigAMI-5 study.

RYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or any of its excipients. Warnings and Precautions include hypersensitivity and administration-related reactions, interstitial lung disease (ILD)/pneumonitis, dermatologic adverse reactions, ocular toxicity and embryo-fetal toxicity.1 Additional Important Safety Information can be found below.

Expert perspectives on improving outcomes for patients with head and neck cancer

"For people living with recurrent or metastatic head and neck cancer, the stakes are incredibly high. I’ve seen firsthand that when the disease progresses, patients often face limited treatment options, while managing symptoms that can affect their ability to eat, speak, swallow and breathe," said Amanda Hollinger, Executive Director, Head and Neck Cancer Alliance. "At a time when treatment advances are urgently needed to improve outcomes for patients, this new option offers renewed hope for patients and their families."

"Outcomes remain poor for patients whose head and neck cancer progresses, and treatment options are limited," said Barbara Burtness, M.D., medical oncologist and professor of medicine at Yale Cancer Center in New Haven, Connecticut.*
"The OrigAMI-4 findings represent important progress and highlight the potential of dual EGFR- and MET-targeting with amivantamab as a distinct treatment approach in recurrent or metastatic head and neck cancer, excluding HPV-associated oropharyngeal squamous cell carcinoma. The meaningful responses observed in this study are encouraging for patients who have long faced limited treatment options."

First Approval for RYBREVANT FASPRO Beyond Lung Cancer

EGFR and MET are key drivers of tumor progression, overexpressed in 80 to 90 percent of recurrent and metastatic HNSCC tumors and often associated with poor prognosis.2 RYBREVANT FASPRO addresses this by targeting both the EGFR and MET pathways simultaneously, while activating immune-cell directing activity – delivered via a five-minute subcutaneous injection.1-2

This approval marks the first indication beyond non-small cell lung cancer (NSCLC) for RYBREVANT FASPRO. It reinforces the potential of the EGFR- and MET-targeted mechanism of amivantamab across multiple difficult-to-treat tumors.

"For years, treatment advances in recurrent or metastatic head and neck cancer have been limited by approaches that do not fully address the underlying biology of the disease," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Innovative Medicine. "RYBREVANT FASPRO delivers a differentiated approach, targeting both EGFR and MET to address the biology that drives this disease. Having redefined outcomes in EGFR+ non-small cell lung cancer, we are unlocking the next chapter of this treatment and bringing meaningful innovation to patients with certain head and neck cancers."

Pivotal Study Results

The FDA accelerated approval is supported by data from the multi-cohort Phase 1b/2 OrigAMI-4 trial. Cohort 1 evaluated RYBREVANT FASPRO as a single agent in 102 adults with previously treated recurrent or metastatic HNSCC who have received platinum-based chemotherapy and an anti‑PD‑(L)1 antibody (excluding patients with HPV-positive OPSCC).1 The pivotal results were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published in the Journal of Clinical Oncology.

Safety

In the OrigAMI-4 trial, the safety profile of RYBREVANT FASPRO was consistent with the well-established safety profile of prior amivantamab experience. No new safety signals were identified, supporting a favorable benefit-risk profile for this advanced patient population. The most common adverse reactions occurring in at least 20 percent of patients were rash (79 percent), fatigue (39 percent), nail toxicity (35 percent), stomatitis (32 percent), and edema (28 percent). Serious adverse reactions occurred in 39 percent of patients. Serious adverse reactions in at least 2 percent of patients included pneumonia (8 percent), hemorrhage (4.9 percent), dysphagia (2.9 percent), pneumothorax (2.9 percent), anemia (2 percent), dyspnea (2 percent), fatigue (2 percent), hepatic enzyme increased (2 percent), and ILD/pneumonitis (2 percent). Fatal adverse reactions occurred in 6 percent of patients who received RYBREVANT FASPRO, including sudden death (2 percent), myocardial ischemia, tumor hemorrhage, aspiration pneumonia, and ILD/pneumonitis (1 percent, one patient each).1

About the OrigAMI-4 Study

OrigAMI-4 is a multi-cohort, multicenter, open-label, ongoing Phase 1b/2 study evaluating RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The study includes six cohorts exploring RYBREVANT FASPRO across different treatment settings and regimens.

Cohort 1 (n=102) evaluated the efficacy and safety of RYBREVANT FASPRO as a single agent in patients with previously treated R/M HNSCC whose disease has progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody. Patients with HPV-associated OPSCC were excluded from Cohort 1. Patients received weight-based RYBREVANT FASPRO every three weeks at the recommended dose and schedule until disease progression or unacceptable toxicity. The primary endpoint is overall response rate (ORR), and the secondary endpoint is duration of response (DOR), both assessed by blinded independent central review (BICR) using RECIST v1.1.†,1

About Head and Neck Squamous Cell Carcinoma

Head and neck squamous cell carcinoma (HNSCC) is the most common form of head and neck cancer, a group of cancers that arise in the mouth, throat, voice box, sinuses, nasal cavity, and salivary glands.4-5 It represents approximately 4.5 percent of all cancers worldwide and is the seventh most common cancer globally.4 Major risk factors include tobacco and alcohol use, as well as infection with high-risk human papillomavirus (HPV).4 Approximately 80 percent of recurrent or metastatic HNSCC are not driven by HPV, and are typically associated with poorer prognosis and reduced response to treatment.4-5 Despite advances in surgery, radiation, chemotherapy, and immunotherapy, many patients ultimately progress to advanced recurrent or metastatic disease.5-6

About RYBREVANT FASPRO and RYBREVANT

RYBREVANT (amivantamab-vmjw) is a first-in-class, fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity. RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) is approved in the U.S. for the same indications as intravenous RYBREVANT across multiple markets. RYBREVANT FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

The FDA accelerated approval RYBREVANT FASPRO in head and neck squamous cell carcinoma (HNSCC) is based on objective response rate (ORR) and duration of response (DOR) results from Cohort 1 of the Phase 1b/2 OrigAMI-4 study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing confirmatory trial, the Phase 3 OrigAMI-5 study (NCT07276399), which is evaluating subcutaneous amivantamab in combination with carboplatin and pembrolizumab as a first-line treatment for patients with recurrent or metastatic head and neck cancer.2 For eligible patients with HNSCC, RYBREVANT FASPRO may be administered every four weeks or every three weeks, according to the recommended dosing schedule.

Beyond HNSCC, RYBREVANT FASPRO is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved for these EGFR-mutated NSCLC populations and may be used as monotherapy or in combination with LAZCLUZE (lazertinib) or chemotherapy, depending on the specific mutation and treatment setting. For eligible patients with NSCLC, RYBREVANT FASPRO offers a once-monthly dosing option following initial weekly dosing.

RYBREVANT-based therapies are being investigated across other solid tumors, including colorectal cancers.

The legal manufacturer for RYBREVANT FASPRO and RYBREVANT is Janssen Biotech, Inc. For more information, visit www.rybrevanthcp.com.

INDICATIONS
RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) and RYBREVANT (amivantamab-vmjw) are indicated:

in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.
as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
RYBREVANT FASPRO is also indicated:

as a single agent for the treatment of adult patients with recurrent or metastatic HNSCC whose disease has progressed on or after platinum‑based chemotherapy and an anti‑PD‑(L)1 antibody.
Limitations of use: RYBREVANT FASPRO is not indicated as a treatment for patients with OPSCC that is HPV-associated (i.e., by p16IHC).
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
RYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO
RYBREVANT FASPRO can cause hypersensitivity and administration-related reactions (ARRs); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours.

RYBREVANT FASPRO with LAZCLUZE
In PALOMA-3 (n=206), all Grade ARR occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARR, 89% occurred with the initial dose (Week 1, Day 1).

RYBREVANT FASPRO as a Single Agent

In OrigAMI-4 (n=132), all Grade ARRs occurred in 16% of patients, with 91% of ARR occurring with the initial dose (Week 1, Day 1). All events were Grade 1 or 2.

Premedicate with antihistamines, antipyretics, and glucocorticoids and administer
RYBREVANT FASPRO as recommended. Monitor patients for any signs and symptoms of ARR during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. For the first dose, monitor patients for hypersensitivity and ARRs for 2 to 4 hours following the end of injection. Interrupt injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue based on severity.

Infusion-Related Reactions with RYBREVANT

RYBREVANT can cause infusion-related reactions (IRRs) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.

RYBREVANT with LAZCLUZE

In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT in 4.5% of patients.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT in 2.8% of patients.

RYBREVANT as a Single Agent

In CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT in 1.3% of patients.

Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT as recommended. Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT.

Interstitial Lung Disease/Pneumonitis

RYBREVANT FASPRO and RYBREVANT can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued

RYBREVANT FASPRO and LAZCLUZE due to ILD/pneumonitis.

RYBREVANT FASPRO as a Single Agent

In OrigAMI-4, ILD/pneumonitis occurred in 1.5% of patients, including one fatal case (0.8%). All of these patients permanently discontinued RYBREVANT FASPRO due to ILD/pneumonitis.

RYBREVANT with LAZCLUZE

In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT and LAZCLUZE due to ILD/pneumonitis.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT due to ILD/pneumonitis.

RYBREVANT as a Single Agent

In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT due to ILD/pneumonitis.

Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.

Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZE

RYBREVANT FASPRO and RYBREVANT in combination with LAZCLUZE can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390).

RYBREVANT with LAZCLUZE

In MARIPOSA (n=421), VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE; 1% of patients had VTE leading to dose reductions of RYBREVANT, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE. The median time to onset of VTEs was 84 days (range: 6 to 777).

Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended.

Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO or RYBREVANT and LAZCLUZE at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO or RYBREVANT. Treatment can continue with LAZCLUZE at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE Prescribing Information for recommended LAZCLUZE dosage modification.

Dermatologic Adverse Reactions

RYBREVANT FASPRO and RYBREVANT can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and
RYBREVANT FASPRO was permanently discontinued due to rash in 1.5% of patients.

RYBREVANT FASPRO as a Single Agent

In OrigAMI-4, rash occurred in 81% of patients, including Grade 3 in 11% and Grade 4 in 0.8%. Rash led to a dose reduction in 11% of patients, and permanent discontinuation in 3% of patients.

RYBREVANT with LAZCLUZE

In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT and 30% for LAZCLUZE, rash leading to dose reductions occurred in 23% of patients for RYBREVANT and 19% for LAZCLUZE, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT and 1.7% for LAZCLUZE.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT and 3.1% discontinued pemetrexed.

RYBREVANT as a Single Agent

In CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%).

When initiating treatment, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment and wear protective clothing and use broad-spectrum UVA/UVB sunscreen.

If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO or RYBREVANT in combination with LAZCLUZE, withhold, dose reduce, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO or RYBREVANT as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT based on severity.

Hepatotoxicity

LAZCLUZE in combination with amivantamab can cause severe hepatotoxicity (including increased ALT and AST).

RYBREVANT with LAZCLUZE

In MARIPOSA, based on adverse reaction data, hepatotoxicity occurred in 49% of patients treated with LAZCLUZE, including Grade 3 in 9.3% of patients and Grade 4 in 0.5%. LAZCLUZE was interrupted for an adverse reaction of hepatotoxicity in 8% of patients, the dose was reduced in 1.4% and permanently discontinued in 0.2%.

Perform liver function tests (including ALT, AST, and total bilirubin) before initiation of LAZCLUZE and during treatment, as clinically indicated. Withhold, dose reduce, or permanently discontinue LAZCLUZE and amivantamab based on severity.

Ocular Toxicity

RYBREVANT FASPRO and RYBREVANT can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3. Keratitis occurred in one patient (0.5%).
RYBREVANT FASPRO as a Single Agent
In OrigAMI-4, ocular toxicity occurred in 11% of patients, including 0.8% Grade 4. Keratitis occurred in one patient (0.8%).

RYBREVANT with LAZCLUZE

In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population, ocular toxicity occurred in 16% of patients. All reactions were Grade 1 or 2.

RYBREVANT as a Single Agent

In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All reactions were Grade 1-2.

Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT and continue LAZCLUZE based on severity.

Embryo-Fetal Toxicity

RYBREVANT FASPRO, RYBREVANT and LAZCLUZE can cause fetal harm when administered to a pregnant woman. Verify pregnancy status prior to initiating treatment. Advise pregnant women and females of reproductive potential of the potential risk to the fetus and to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO or RYBREVANT, and for 3 weeks after the last dose of LAZCLUZE.

ADVERSE REACTIONS

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3 (n=206), the most common adverse reactions (≥20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gamma-glutamyl transferase (2%), and decreased hemoglobin (2%).

Serious adverse reactions occurred in 33% of patients, with those occurring in ≥2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each).

RYBREVANT FASPRO as a Single Agent

In OrigAMI-4 (n=102), the most common adverse reactions (≥20%) were rash (79%), fatigue (39%), nail toxicity (35%), stomatitis (32%), and edema (28%). The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were decreased lymphocytes (26%), decreased potassium (9%), decreased hemoglobin (6%), increased alanine aminotransferase (4.9%), decreased albumin (4.9%), decreased sodium (4.9%), increased aspartate aminotransferase (3.9%) and decreased white blood cells (2%).
Serious adverse reactions occurred in 39% of patients. Serious adverse reactions in ≥2% of patients included pneumonia (8%), hemorrhage (4.9%), dysphagia (2.9%), pneumothorax (2.9%), anemia (2%), dyspnea (2%), fatigue (2%), hepatic enzyme increased (2%), and ILD/pneumonitis (2%). Fatal adverse events occurred in 6% of patients who received RYBREVANT FASPRO including sudden death (2%), myocardial ischemia, tumor hemorrhage, aspiration pneumonia, and ILD/pneumonitis (1%, 1 patient each).

RYBREVANT with LAZCLUZE

In MARIPOSA (n=421), the most common adverse reactions (ARs) (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRR) (RYBREVANT) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%).

Serious ARs occurred in 49% of patients, with those occurring in ≥2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).

RYBREVANT with Carboplatin and Pemetrexed

In MARIPOSA-2 (n=130), the most common ARs (≥20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%).

Serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).

In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).

Serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.

RYBREVANT as a Single Agent

In CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).

Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.

LAZCLUZE DRUG INTERACTIONS

Avoid concomitant use of LAZCLUZE with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.

Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.

Please read full Prescribing Information for RYBREVANT FASPRO, RYBREVANT, and LAZCLUZE.

(Press release, Johnson & Johnson, NOV 5, 2026, View Source [SID1234674316])

On November 5, 2026 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, reported financial results for the quarter ended September 30, 2026, and provided a business update.

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"During the third quarter, we continued to execute across our clinical portfolio, including dosing the first patient in the Phase 1 study of JANX013 in combination with JANX007," said David Campbell, Ph.D., President and Chief Executive Officer of Janux. "We are also preparing to present initial clinical data from JANX011 on November 9. JANX011 was designed to achieve deep B-cell depletion while limiting cytokine release. The upcoming clinical update will provide an initial look at how this differentiated approach translates into humans."

BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS:

Clinical and Pipeline Progress

•
JANX007 (PSMA-TRACTr) continues to advance through Phase 1b development in metastatic castration-resistant prostate cancer (mCRPC), with ongoing dose optimization and expansion in taxane-naïve patients, including an actively enrolling cohort evaluating JANX007 in combination with darolutamide.
•
JANX014 (PSMA-TRACTr), a double-masked, PSMA-targeted tumor-activated T-cell engager, continues enrollment in its Phase 1 clinical study evaluating safety, pharmacokinetics and preliminary antitumor activity in patients with mCRPC.
•
JANX011 (CD19-ARM) continues to be evaluated in a Phase 1 clinical study in healthy volunteers. JANX011 is Janux’s first clinical candidate from its Adaptive Immune Response Modulator (ARM) platform and was designed to achieve deep and durable B-cell depletion while limiting cytokine release. Initial clinical data from the study will be presented during an investor webcast on November 9, 2026.
•
Janux recently disclosed that JANX011 selectively engages TRBV6-expressing T cells rather than broadly engaging the CD3+ T cell population, a differentiated approach intended to focus immune activation on a defined T cell subset.
•
JANX013 (PSMA-TRACIr) The first patient has been dosed in the Phase 1 study evaluating JANX013 in combination with JANX007 in patients with mCRPC, representing the first clinical evaluation of Janux’s TRACIr platform.

Upcoming Milestones

•
Initial clinical data from the Phase 1 healthy-volunteer study of JANX011 will be presented during an investor webcast, providing the first clinical evaluation of Janux’s ARM platform.
•
Additional clinical data from the Phase 1b study of JANX007 are expected to be presented at a medical congress in the first half of 2027.

THIRD QUARTER 2026 FINANCIAL RESULTS:

•
Cash and cash equivalents and short-term investments: As of September 30, 2026, Janux reported cash and cash equivalents and short-term investments of $945.7 million, compared to $966.6 million as of December 31, 2025.
•
Research and development expenses: Research and development expenses were $30.6 million for the quarter ended September 30, 2026, compared to $34.6 million for the comparable period in 2025.
•
General and administrative expenses: General and administrative expenses were $10.0 million for the quarter ended September 30, 2026, compared to $10.6 million for the comparable period in 2025.
•
Net loss: Net loss was $21.6 million for the quarter ended September 30, 2026, compared to $24.3 million for the comparable period in 2025.

(Press release, Janux Therapeutics, NOV 5, 2026, View Source [SID1234674315])

On November 5, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported third quarter 2026 financial results, business achievements, and corporate updates.

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"Third quarter revenue reached a new record of ~$122 million with our highest gross margin ever, driven by continued U.S. Amtagvi demand," said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President. "We remain on track to achieve our full-year 2026 total revenue guidance of $410 to $420 million and recently marked the tremendous milestone of more than 1,000 commercially treated Amtagvi patients. We released our positive results for Cohorts 1 and 2 of our ongoing IOV-LUN-202 trial with a 24.6% ORR in 69 patients and excellent durability that is much greater than current standard of care. We are completing enrollment in Cohorts 1 and 2 and preparing for a supplemental Biologics License Application (sBLA) submission, while adding the new POSITILITY and OPTILISM trials supported by a remarkable 59.1% ORR in biomarker-selected patients. We also recently presented best-in-class data for lifileucel in chemotherapy-refractory UPS and DDLPS in support of our SARATOGA registrational trial, where our confirmed ORR has now increased to 55.6% in 9 patients with strong durability."

Third Quarter 2026 Financial Highlights

Second Consecutive Record Quarter in Revenue and High Margin Driven by Volume and Cost Discipline

· Total product revenue was ~$122 million, an increase of ~80% from ~$67 million in 3Q25 and ~22% from ~$99 million in 2Q26.
· U.S. Amtagvi revenue was ~$102 million, up ~77% from 3Q25 and ~12% from 2Q26. Global Proleukin revenue was ~$20 million in 3Q26.
· Gross margin1 was ~60%, compared to 56% in 2Q26, reflecting higher Amtagvi sales volume and effective internal cost optimization programs spanning all of product production.
· Research and Development (R&D) expenses decreased by ~16% compared to 2Q26, driven by operational efficiencies, marking the fifth straight quarter of improvements, and allowing pipeline growth in additional indications with significant market opportunity.

Full Year 2026 Outlook

Third Quarter Performance and Demand Growth Support Guidance

· Iovance remains on track towards achieving its guidance range of $410 to $420 million in total product revenue in 2026.
· Improvements in gross margin are expected to continue, excluding occasional one-time items.

Amtagvi Commercial Business

Sustained U.S. Commercial Business Growth and Upcoming Milestones in Global Expansion

· Authorized treatment center (ATC) network: The network has grown to more than 100 U.S., Canadian, and Australian ATCs, with at least 110 ATCs expected to be active by the end of 2026. Community ATCs continue to represent a third of the network and are expected to increase significantly over the next several quarters.
· Real-world experience: Numerous real-world studies by Iovance and ATCs using commercial Amtagvi continue to highlight efficacy and safety, with objective response rates (ORRs) of 50% or greater in second-line patients, supporting earlier adoption of Amtagvi with rapid patient referrals and access. In a poster at the European Society for Medical Oncology Congress 2026 (ESMO 2026), an indirect comparison suggested that lifileucel may approximately double four-year overall survival (OS) rates compared with standard-of-care therapies in anti-PD-1-resistant advanced melanoma.
· Manufacturing turnaround time: Amtagvi turnaround time for the majority of lots is about 30 days or less using the only scaled, centralized commercial manufacturing process approved by the U.S. Food and Drug Administration (FDA) for TIL therapy.
· United Kingdom (UK): The Marketing Authorization Application (MAA) was resubmitted and is undergoing expedited review by the Medicines and Healthcare products Regulatory Agency for potential approval by 1Q27. Advanced melanoma causes more than 2,500 deaths annually in the UK.
· Switzerland: A potential MAA approval by Swissmedic is expected in 1Q27, and the process is moving smoothly, opening a second market opportunity in Europe with the added potential for medical tourism. Switzerland’s domestic melanoma burden causes several hundred deaths annually.
· Other markets and indications: Iovance is planning to submit an MAA for Amtagvi in advanced melanoma to the Brazilian Health Regulatory Agency (ANVISA) in 2027. An MAA resubmission for Amtagvi to the European Medicines Agency is on track for 2027. Other regulatory submissions are planned in international markets with a high prevalence of advanced melanoma, lung cancer, and soft tissue sarcomas.

Clinical and Regulatory Pipeline Updates

Progress Across a Deep Pipeline of Registrational Programs

· IOV-LUN-202, POSITILITY, and OPTILISM: Iovance recently reported a 24.6% ORR in 69 patients with non-squamous mNSCLC, including two unconfirmed responses, consistent with previously reported results. IOV-LUN-202 Cohorts 1 and 2 are completing enrollment. An sBLA for lifileucel based on Cohorts 1 and 2, with a target of approximately 80 patients, is planned in 2027. Independent review committee assessments, FDA discussions, and other pre-submission activities, including confirmatory trial preparation, are ongoing.
- Efficacy results are potentially best-in-class, with durability continuing to mature and already much greater than standard of care, including docetaxel, which offers an ORR of only 12.8%, a durability of only 5.6 months, and median overall survival of 12.3 months.2
- The safety profile remains consistent with lifileucel regimen experience and was improved after switching to reduced-dose lymphodepletion.
- The FDA awarded Fast Track Designation (FTD) on the strength of the clinical data and the high unmet medical need of mNSCLC patients.
- A novel biomarker-enriched subgroup within IOV-LUN-202 achieved a 59.1% ORR, leading to the start of POSITILITY, a first-in-class biomarker-enriched cohort with registrational intent, with enrollment beginning this month and a target of 80 patients.
- Iovance plans to initiate OPTILISM, an innovative frontline trial in biomarker-enriched non-squamous mNSCLC, in 2027. The U.S. market opportunity in frontline and second-line non-squamous mNSCLC in the biomarker-selected cohort is about ten times that of advanced melanoma.
- Translational data in a poster at ESMO (Free ESMO Whitepaper) 2026 showed enrichment over time of putative tumor-reactive clones in mNSCLC patients responding to lifileucel in IOV-LUN-202.
· SARATOGA (IOV-SAR-201): A registrational trial in UPS and DDLPS, with approximately 40 patients in each indication, is actively enrolling patients refractory to at least one prior line of anthracycline chemotherapy. Iovance has aligned with the FDA on the registrational trial design and potential accelerated approval pathway. The FDA granted FTD in both indications in 2Q26.
- Results of lifileucel in heavily pretreated UPS and DDLPS, with 84% of patients receiving two or more prior lines of therapy, were highlighted in a Rapid Oral presentation at ESMO (Free ESMO Whitepaper) 2026.
- In an updated data analysis conducted after ESMO (Free ESMO Whitepaper), the confirmed ORR by RECIST v1.1 increased to 55.6% (5/9) with multiple durable responses observed, including two responses ongoing more than a year from infusion.
- The U.S. market opportunity in UPS and DDLPS is approximately the same size as the current second-line metastatic melanoma opportunity for Amtagvi.
· TILVANCE-301: A Phase 3 randomized trial of lifileucel and pembrolizumab is enrolling patients with frontline advanced melanoma across a broad global footprint. The TILVANCE-301 trial includes an early interim analysis based on ORR for a potential sBLA for frontline advanced melanoma. The trial also serves as the confirmatory study for the accelerated approval of lifileucel in second-line advanced melanoma.
- An oral presentation at ESMO (Free ESMO Whitepaper) 2026 reinforced the rationale for TILVANCE-301 with Phase 2 results of the combination of lifileucel and pembrolizumab as a potential best-in-class option for frontline advanced melanoma. The confirmed ORR was 62.5%, the complete response rate was 29.2%, and median OS was not reached at a median follow-up of more than four years in the IOV-COM-202 trial (n=24).
- Enrollment momentum in TILVANCE-301 is accelerating at more than 80 sites in the U.S., Canada, Europe, and Asia-Pacific. The clinical site network is expanding into new regions, contributing to ongoing robust enrollment.
· ENDURANCE (IOV-END-201): Positive initial data in previously treated metastatic serous endometrial cancer using a biomarker strategy based on histology were reported in 1Q26. Enrollment of serous endometrial patients in ENDURANCE will restart, and discussion with the FDA is planned on an expedited approval pathway to focus on this population.

Next-Generation Pipeline Updates

First-in-Class Immuno-Oncology Technologies Target New Indications

· POTENTIL (IOV-GE1-201): A Phase 1/2 trial is actively enrolling using IOV-5001, a second-generation IL-12 tethered TIL therapy designed to remodel the suppressive tumor microenvironment (TME) and activate immunologically "cold tumors" to support TIL responses and boost response rates.3 Cohorts include metastatic colorectal cancer, triple-negative and estrogen receptor-low breast cancers, and other solid tumors causing more than 100,000 annual U.S. deaths.4
· IOV-GM1-201: A Phase 1/2 trial investigating IOV-4001, a PD-1 inactivated TIL therapy, is enrolling patients with previously treated metastatic melanoma and mNSCLC. IOV-4001 is engineered to resist inhibitory signals and enhance the ability of TIL therapies to fight and kill cancer in the TME.
· IOV-IL2-101: A Phase 1 safety cohort is advancing through multiple dose levels in the Phase 1/2 trial of IOV-3001, a second-generation modified IL-2 analog for the TIL treatment regimen. IOV-3001 selectively expands effector T cells while avoiding activation of regulatory T cells with the potential for a lower-dose IL-2 regimen with reduced adverse events. IOV-3001 is expected to be superior to Proleukin as a component of future TIL regimens.
· Investigator-sponsored trials (ISTs): Iovance continues to advance its broad IST portfolio in multiple new indications for lifileucel. A new IST of lifileucel in clear cell renal cell carcinoma (ccRCC) recently commenced. An ongoing IST of lifileucel in cutaneous squamous cell carcinoma (CSCC) and Merkel cell carcinoma (MCC) is accelerating. Confirmed clinical activity in both CSCC and MCC was observed, and initial results are expected in 1H27. With a lack of effective therapies after failure of checkpoint inhibitors and other frontline combinations, lifileucel could address a large CSCC, MCC, and ccRCC population suffering from thousands of annual deaths in the U.S. alone.

Corporate Updates

· Iovance currently owns or licenses more than 400 granted or allowed U.S. and international patents and patent rights for Amtagvi and other TIL-related technologies, including patent rights directed to its biomarker-directed strategy, and has filed more than 1,000 additional patent applications worldwide. This broad patent portfolio is expected to provide patent exclusivity through at least 2042 and beyond.
· Iovance entered into a contract research agreement with Cell and Gene Therapy Catapult, a UK independent innovation and technology organization advancing cell and gene therapies, with an option to license a next-generation smart manufacturing platform.
· As of September 30, 2026, Iovance’s cash position5 was ~$382 million, and current cash is expected to fund operations well into 2029.

Webcast and Conference Call

Management will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 8:30 a.m. ET. To listen to the live or archived audio webcast, please register at View Source The live and archived webcast can be accessed in the Investors section of the Company’s website, iovance.com, for one year.

1. Excludes depreciation and amortization.

2. Ahn MJ, Tanaka K, et al., J Clin Oncol 2025;43:260–272.

3. Zhang L, Rosenberg SA, et al., Clin Cancer Res 2015;21(10):2278–2288.

4. Surveillance, Epidemiology, and End Results Program Cancer Stat Facts (accessed November 2026).

5. Cash, cash equivalents, short-term investments, and restricted cash as of September 30, 2026.

(Press release, Iovance Biotherapeutics, NOV 5, 2026, View Source [SID1234674314])

On November 5, 2026 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported third quarter 2026 financial results and provides a business update.

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Management will host a conference call and live webcast at 8:00 a.m. Eastern time today to review financial results and provide an update. The archived webcast will be available for replay shortly after the close of the call.

Conference Call Details
Date: November 5, 2026
Time: 8:00 a.m. Eastern Time
Domestic Dial-In: (866) 652-5200
International Dial-In: (412) 317-6060
Webcast URL: View Source

Business Update

INVINCIBLE-3 Study: Phase 3 open-label, randomized controlled, multicenter study testing INT230-6 as monotherapy compared with standard-of-care ("SOC") in second- and third-line treatment of certain soft tissue sarcoma subtypes.
In March 2025, the Company paused new site activations and patient enrollment due to funding constraints. At that time, the trial had enrolled 21 patients, and the Company continued to treat all patients, maintain the database, conduct pharmacovigilance, and conduct other study-related activities in cooperation with its contract research organizations at significantly reduced ongoing costs. During this pause, the Company obtained important feedback and recommendations about the trial from key investigators and sarcoma thought leaders, and modifications to the protocol were made.
In April 2026, with a strengthened balance sheet, the Company initiated activities to resume enrollment in a limited number of U.S. sites in the INVINCIBLE-3 Study using an FDA-reviewed amended protocol. New patient enrollment activities resumed in the third quarter of 2026. Several sites are now activated and patients have been identified. Submission of documentation necessary for restarting in the EU and Canada is in process. Increased site activation and patient enrollment rates are expected as sufficient incremental funding is obtained.

INVINCIBLE-4 Study: Phase 2 open-label, randomized controlled, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before SOC in patients with early-stage, operable TNBC (Cohort A) and SOC alone (Cohort B).
In September 2025, the Company paused new patient enrollment to revise the dosing regimen for patients receiving INT230-6 in Cohort A due to some patients experiencing localized skin irritation near the tumor site. A protocol amendment has been approved by the Swissmedic, the Swiss Ethics Committee and the French National regulatory agency to use a lower drug volume per tumor volume ratio and a single injection of INT230-6 in Cohort A.
In July 2026, the Company restarted patient enrollment and treatment in the INVINCIBLE-4 Study and is currently targeting complete enrollment by the end of 2027. The Swiss Cancer Institute, the Company’s collaborator in the INVINCIBLE-4 Study, has established an independent data monitory board ("IDMB") comprised of qualified experts to review the safety data and images of these newly treated patients to assess whether the skin irritation issue has been resolved. We plan to provide an update upon completion of IDMB review in the first quarter of 2027. In August 2026, the Company opened its first site in France for accrual and several sites have now been activated.
Preliminary data from the first 14 patients (seven in each cohort) showed a 71% pathological complete response ("pCR") in patients receiving INT230-6 in Cohort A and a 42% pCR in patients receiving the SOC alone (Cohort B). There was also a 44% reduction in grade 3 adverse events in Cohort A compared to Cohort B and fewer immune-related adverse events when our INT230-6 was added prior to the immunochemotherapy. In addition, no invasive breast cancer cells were detected in the axillary lymph nodes in 6 of the 7 patients in Cohort A after INT230-6 treatment, despite 5 (71%) of these patients being initially biopsy-proven node-positive. Results also showed tumor necrosis after 1 or 2 injections in all 7 Cohort A patients. In the pre-surgery MRI at the completion of neoadjuvant immunochemotherapy, four (57%) patients had RECIST 1.1 radiological complete response and three patients (43%) partial response. All patients exhibited necrosis in their tumors and all 7 patients met criteria for breast-conserving surgery, but one proceeded with mastectomy owing to a high-risk germline mutation.

Capital Raises
In March 2026, the Company established a $60 million at-the-market ("ATM") facility. During the third quarter of 2026, the Company raised net proceeds of $1.5 million under the ATM. During the nine months ended September 30, 2026, the Company raised net proceeds of $3.2 million under the ATM.
"We are excited that recruitment of patients has been reinitiated in both of our trials," stated Lewis H. Bender, President and CEO of Intensity Therapeutics, Inc. "In the Phase 3 INVINCIBLE-3 Study, the protocol adjustments have been well received by investigators, and several sites in the United States are now activated and identifying patients. We also met several of the INVINCIBLE-3 Study investigators from Europe and Canada at ESMO (Free ESMO Whitepaper), who have expressed a strong desire to restart patient enrollment in their countries as well. In the Phase 2 INVINCIBLE-4 Study, we have met in person with several of our Swiss sites. The Swiss Cancer Institute is currently collecting safety data on the newly treated patients. We look forward to receiving our partner’s planned IDMB report of the safety data and conclusions on the skin issue of these newly treated patients in Q1 2027. Assuming a positive report, we will have confidence that the skin issue is resolved. Coupled with the data so far on overall safety and the potential for improved efficacy, we believe there is good motivation for sites to enroll patients in the INVINCIBLE-4 Study. Finally, we continue to pursue business development opportunities, and have had follow-up discussions with several organizations at ESMO (Free ESMO Whitepaper) from our prior meetings at ASCO (Free ASCO Whitepaper) and BIO."

Third Quarter 2026 Financial Results

Research and development expenses were $2.4 million for the third quarter of 2026, compared with $1.6 million for the same period in 2025. The increase was primarily due to higher INVINCIBLE-3 Study costs as the Company resumed new patient enrollment activities in a limited number of U.S. sites in the third quarter of 2026. The Company paused new site activations and patient enrollments in March 2025 due to funding constraints. Research and development expenses also increased due to the initiation of a new INT230-6 manufacturing batch during the third quarter of 2026, an estimated bonus accrual during the third quarter of 2026 compared with no bonus accrual during the third quarter of 2025, and higher stock-based compensation.

General and administrative expenses were $1.2 million for the third quarter of 2026, unchanged compared with $1.2 million for the same period in 2025.

Net loss was $3.5 million for the third quarter of 2026, compared with a net loss of $2.7 million for the third quarter of 2025.

As of September 30, 2026, cash and cash equivalents totaled $8.5 million. During the third quarter of 2026, the Company raised $1.6 million under the ATM, for net proceeds of $1.5 million.

About Triple Negative Breast Cancer in the Presurgical Setting
Women with aggressive forms of breast cancer, such as TNBC, are often counseled to undergo neoadjuvant (presurgical) systemic therapy to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of disease recurrence from 50% to 16% at 5 years. Approximately 11% to 17% of breast cancers test negative for estrogen receptors ("ER"), progesterone receptors ("PR"), and overexpression of human epidermal growth factor receptor 2 ("HER2") protein, qualifying them as triple negative. There are approximately 56,000 new cases of TNBC in the US and 420,000 worldwide diagnosed each year, 85% of which are local to the breast. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immunochemotherapy before surgery. Since the publication of Keynote-522, the standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates range from 50% to 65%, depending on tumor size. Rates are generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 77% of patients experiencing grade 3 or higher treatment-related adverse events, including treatment-related adverse events that lead to death in 0.5% of patients.
About Sarcoma
Soft tissue sarcoma is a rare type of cancer that starts with the growth of cells in the body’s soft tissue, such as muscle, fat, blood vessels, nerves, tendons, and linings of the joints. The disease mostly occurs in the arms, legs and abdomen. There are 197,000 patients in the US living with sarcoma and more than 100 types of soft tissue sarcoma, the treatment of which first involves surgery. Other treatments might include radiation therapy and then chemotherapy. Using the U.S. SEER database, the Company estimated that 14,400 patients have regional or distal (metastatic) leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma.
About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

(Press release, Intensity Therapeutics, NOV 5, 2026, View Source [SID1234674313])