Intensity Therapeutics, Inc. Provides Update on the Phase 2 Presurgical Triple-Negative Breast Cancer INVINCIBLE-4 Study

Rhea-AI Summary

Intensity Therapeutics (Nasdaq: INTS) reported preliminary INVINCIBLE-4 presurgical TNBC results through March 2, 2026. Fourteen patients have been treated (7 per cohort) of a planned 61. Cohort A (INT230-6 + SOC) showed pCR in 5/7 (71.4%) vs 2/6 (33%) in SOC alone; one SOC patient remains unevaluated.

A protocol amendment to Swissmedic and the Swiss Ethics Committee was submitted to resume enrollment after a September 2025 pause for skin irritations; Cohort A showed 44% fewer grade 3+ AEs versus SOC.

Positive

• Pathological complete response 71.4% in INT230-6 plus SOC (5 of 7 patients)
• Pathological complete response 33% in SOC alone (2 of 6 patients, one unevaluated)
• Observed 44% fewer grade 3+ adverse events in INT230-6 plus SOC versus SOC

Negative

• Enrollment paused in September 2025 due to skin irritations
• Only 14 patients treated to date of planned 61, so results are preliminary

Market Reaction – INTS

-6.07% $7.43

15m delay 6 alerts

-6.07% Since News

$7.43 Last Price

$7.17 $7.92 Day Range

-$1M Valuation Impact

$19M Market Cap

0.8x Rel. Volume

Following this news, INTS has declined 6.07%, reflecting a notable negative market reaction. Our momentum scanner has triggered 6 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $7.43. This price movement has removed approximately $1M from the company's valuation.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

Cohort A pCR rate: 5/7 patients (71.4%) Cohort B pCR rate: 2/6 patients (33%) Grade 3+ AE reduction: 44% fewer events +5 more

8 metrics

Cohort A pCR rate 5/7 patients (71.4%) INT230-6 plus SOC in INVINCIBLE-4 presurgical TNBC

Cohort B pCR rate 2/6 patients (33%) SOC alone in INVINCIBLE-4 presurgical TNBC

Grade 3+ AE reduction 44% fewer events Cohort A vs Cohort B in INVINCIBLE-4

Grade 3+ AEs Cohort A 14 events (1 immune-related) INT230-6 plus SOC safety through March 2, 2026

Grade 3 SOC AEs Cohort B 25 events (4 checkpoint-related) SOC-only arm in INVINCIBLE-4

Tumor size criterion ≥ 1.5 cm INVINCIBLE-4 enrollment threshold vs >1.0 cm in Keynote-522

Patients treated to date 14 patients (7 per cohort) Current INVINCIBLE-4 enrollment status

Keynote-522 AE rate 77% grade 3+ AEs; 0.5% deaths Historical safety profile of SOC immunochemotherapy regimen

Market Reality Check

Price: $7.91 Vol: Volume 19,717 is 0.24x th...

low vol

$7.91 Last Close

Volume Volume 19,717 is 0.24x the 20-day average of 81,466, indicating light trading ahead of this update. low

Technical Shares at $7.91, trading below the 200-day MA of $8.77 and 87.34% under the 52-week high.

Peers on Argus

Sector peers show mixed moves: ERNA -3.28%, BOLT -3.05%, SNSE -1.64%, LYRA +0.77...

1 Up

Sector peers show mixed moves: ERNA -3.28%, BOLT -3.05%, SNSE -1.64%, LYRA +0.77%, MBRX +1.50%. Only MBRX appeared in momentum scanning, moving up 2.46%, suggesting this update is stock-specific rather than part of a broad biotech rotation.

Previous Clinical trial Reports

5 past events · Latest: 2025-10-30 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
2025-10-30	INT230-6 solid tumor data	Positive	+394.6%	Publication of Phase 1/2 INT230-6 results with strong efficacy and safety.
2025-06-11	INVINCIBLE-4 early TNBC data	Positive	+15.1%	Early INVINCIBLE-4 data showing high tumor necrosis after INT230-6.
2025-05-29	INVINCIBLE-3 ASCO selection	Positive	+24.0%	Phase 3 sarcoma trial selected for ASCO with strong prior survival data.
2025-05-06	INVINCIBLE-4 EMA expansion	Positive	-1.9%	EMA authorization to expand INVINCIBLE-4 into France with 54 patients.
2025-01-28	INVINCIBLE-3 DMC review	Positive	-0.9%	DMC authorizes continuation of Phase 3 sarcoma trial without changes.

Pattern Detected

Clinical trial news for INT230-6 has often led to strong positive moves, though some clinically positive updates have seen muted or negative price reactions.

Recent Company History

Over the past year, Intensity has repeatedly highlighted INT230-6 clinical progress across solid tumors, sarcoma, and TNBC. Key events include eBioMedicine Phase 1/2 data with a 75% disease control rate and favorable safety, DMC support to continue the Phase 3 INVINCIBLE-3 sarcoma trial, and EMA authorization plus early INVINCIBLE-4 TNBC necrosis findings. These updates, generally associated with sizeable stock moves (including a 394.57% jump), frame today’s INVINCIBLE-4 pCR and safety observations as part of a continuing clinical narrative.

Historical Comparison

+86.2% avg move · Prior clinical-trial headlines for INT230-6 moved INTS an average of 86.18%. Today’s INVINCIBLE-4 pC...

clinical trial

+86.2%

Average Historical Move clinical trial

Prior clinical-trial headlines for INT230-6 moved INTS an average of 86.18%. Today’s INVINCIBLE-4 pCR and safety update extends the same TNBC program highlighted since 2025, reinforcing an ongoing efficacy–safety storyline.

Clinical updates progressed from DMC support for Phase 3 sarcoma, to EMA expansion and early necrosis data in INVINCIBLE-4 TNBC, to publication of broad Phase 1/2 INT230-6 results. Today’s presurgical TNBC pCR and safety observations further develop the INVINCIBLE-4 dataset.

Market Pulse Summary

The stock is down -6.1% following this news. A negative reaction despite encouraging early pCR and s...

Analysis

The stock is down -6.1% following this news. A negative reaction despite encouraging early pCR and safety findings would fit past instances where positive clinical news still saw divergence. Only 14 patients have been treated so far, and results are explicitly described as preliminary, which may temper confidence. The share price remained far below the $62.49 52-week high and under the $8.77 200-day average before this update, suggesting broader overhangs from financing needs and prior volatility could weigh on responses to incremental data.

Key Terms

pathological complete response, pCR, adverse events, aEs, +2 more

6 terms

pathological complete response medical

"achieved a pathological complete response ("pCR") whereas two (2) out of six"

Pathological complete response is when tissue examined under a microscope after cancer treatment and surgery shows no remaining invasive tumor cells. Investors care because it is a strong signal that a therapy is working, often used as a key endpoint in clinical trials and a predictor of better long‑term outcomes; like finding an empty crime scene after a cleanup, it can boost confidence in a drug’s market potential and regulatory prospects.

pCR medical

"patients undergo the Keynote-522 regimen in an attempt to obtain a pCR"

PCR (polymerase chain reaction) is a laboratory method that makes many copies of a tiny piece of genetic material (DNA or RNA) so scientists can detect and study it reliably — think of photocopying a faint, tiny note until the words are easy to read. For investors, PCR matters because it underpins diagnostic tests, drug development, and biotech tools whose sales, regulatory approvals, and real-world use can materially affect company revenues and market perceptions during health events or product launches.

adverse events medical

"Forty-four percent (44%) fewer grade 3 or higher Adverse Events ("AEs")"

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

aEs medical

"There has been a total of fourteen (14) grade 3 or higher AEs, only one (1)"

Adverse events (AEs) are any unwanted or unexpected medical problems that occur in people taking a drug or being treated in a clinical trial, ranging from mild side effects to serious health issues. Investors track AEs because they act like warning lights on a company’s development program—the number, severity, or pattern of AEs can delay or block approvals, change market expectations for a product, and materially affect a company’s future revenue and valuation.

pembrolizumab medical

"consisting of pembrolizumab every three weeks, then paclitaxel, followed by"

A cancer immunotherapy drug that helps the body’s immune system recognize and attack tumor cells by blocking a molecular “brake” that tumors use to hide. Investors watch it because regulatory approvals, clinical trial results, dosing rules, and competition directly affect potential sales, profit forecasts, and the valuation of companies that sell or license the drug—think of trial outcomes as checkpoint signs that can open or close a revenue road.

immune checkpoint inhibitors medical

"of which four (4) are considered common or rare side effects of immune checkpoint inhibitors"

Drugs that release the immune system’s natural “brakes,” allowing immune cells to recognize and attack cancer cells; imagine taking the safety off a guard dog so it can chase intruders. They matter to investors because they can become high-value treatments with large sales potential, but their commercial success depends on clinical trial results, regulatory approval, competition and side-effect management, which all affect a company’s valuation.

AI-generated analysis. Not financial advice.

• Preliminary observations of the INVINCIBLE-4 Study to date showed that five (5) out of seven (7) patients (71.4%) who received INT230-6 prior to standard of care ("SOC") ("Cohort A") achieved a pathological complete response ("pCR") whereas two (2) out of six (6) (33%) patients in the SOC arm alone ("Cohort B") achieved a pCR, with one patient still to be evaluated.
   
• Forty-four percent (44%) fewer grade 3 or higher Adverse Events ("AEs") were observed in Cohort A compared to Cohort B.
  
  
• A protocol amendment has been submitted to the Swiss Agency for Therapeutic Products ("Swissmedic"), Switzerland's regulatory authority, and the Swiss Ethics Committee to resume enrollment.

SHELTON, Conn., March 12, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, provided an update on the INVINCIBLE-4 Study. In September 2025, enrollment was paused by the Company due to skin irritations observed in Cohort A. In early March 2026, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee to resume enrollment using a lower drug volume per tumor volume ratio and a single injection of INT230-6.

The SOC in the INVINCIBLE-4 Study is the Keynote-522 study regimen, a 6-month presurgical treatment consisting of pembrolizumab every three weeks, then paclitaxel, followed by carboplatin and 4 doxorubicin or epirubicin with cyclophosphamide. The INVINCIBLE-4 Study enrollment criteria is limited to patients with tumors sizes ≥ 1.5 cm, whereas the Keynote-522 study enrolled tumors > 1.0 cm.  As a result, patients in the INVINCIBLE-4 Study, on average, have larger tumors than patients in the Keynote-522 study. Patients undergo the Keynote-522 regimen in an attempt to obtain a pCR, which has been shown to significantly reduce the risk of disease recurrence. pCR is an endpoint that the U.S Food and Drug Administration ("FDA") and the European Medicines Agency could allow for an accelerated or conditional marketing approval.

Overall, fourteen (14) patients have been treated to date in the INVINCIBLE-4 Study, with seven (7) in each cohort. The expected total enrollment is up to sixty-one (61) patients.  Preliminary observations for the fourteen patients treated to date are as follows:

pCR Data Observations

• Cohort A: A pCR was achieved in five (5) out of seven (7) patients (71.4%) who received injections of INT230-6 prior to SOC. Six (6) patients received two (2) injections and one patient, who achieved a pCR, received one (1) injection.
  
  
• Cohort B: A pCR was achieved in two (2) out of six (6) patients (33%) who received the SOC alone, with one patient still to be evaluated.

The pCR analysis is ongoing, and results are preliminary and early.

Safety Data Observations (through March 2, 2026)

• Cohort A: There has been a total of fourteen (14) grade 3 or higher AEs, only one (1) of which is considered a common immune-related side effect of checkpoint immunotherapy.
  
  
• Cohort B: There has been a total of twenty-five (25) SOC-related grade 3 AEs, of which four (4) are considered common or rare side effects of immune checkpoint inhibitors (three grade 3 and one grade 4).

The safety data for patients who received INT230-6 plus SOC remain favorable compared with SOC alone.

In the Company's first presurgical Breast Cancer study completed in 2023 (the "INVINCIBLE-2 Study"), fifty-eight (58) women received one (1) to three (3) injections of only INT230-6. Additionally, skin issues were rare, and surgery was performed without complications.

The Company expects presentation of more detailed results for the seven (7) Cohort A patients at a future oncology conference.

Lewis H. Bender, Founder, President & CEO, said, "The pCR data observations to date in the INVINCIBLE-4 study are promising, though preliminary and early. We are also pleased to see fewer total grade 3 or higher adverse events and fewer adverse events associated with checkpoint inhibitors when our drug is combined with immunochemotherapy in Cohort A than seen in Cohort B. The safety observed to date is consistent with our prior results using our drug with immunotherapy in mice¹ and humans, which have been presented at oncology conferences or published in peer-reviewed journals."²      

Mr. Bender continued, "Triple-negative breast cancer is one of the most aggressive and difficult to treat subtypes. As reported in the Keynote-522³ study, 77% of patients using the current SOC immunochemotherapy regimen alone have grade 3 or higher systemic adverse events, and 0.5% of patients died from the regimen. Reducing the total number of grade 3 or higher adverse events by 44%, especially immune-related adverse events, and the potential for a higher pCR rate with INT230-6 prior to SOC, could be life-saving for patients. With the amendment now filed with Swissmedic, we look forward to dosing the next patient."

About Triple Negative Breast Cancer in the Presurgical Setting

Women with aggressive forms of breast cancer, such as Triple Negative Breast Cancer ("TNBC"), are often counseled to undergo pre-surgical (neoadjuvant) systemic therapy in advance 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 AEs, including treatment-related adverse events that lead to death in 0.5% of patients. 

About a Potential INT230-6 Approval Pathway in the Presurgical Setting

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions and that fill an unmet medical need based on a surrogate endpoint. pCR is an accepted FDA accelerated approval criterion for approval in high-risk breast cancer, such as TNBC subtype. Pathological complete response is defined as the absence of residual invasive and in situ cancer after evaluation of the completely resected breast specimen and lymph nodes following completion of neoadjuvant systemic therapy. If a product is approved using pCR, companies must still seek full approval using event-free survival as an endpoint.

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.

About the INVINCIBLE-4 Study

The INVINCIBLE-4 study is a Phase 2 non-comparative, hypothesis-driven randomized open-label, two-cohort multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC immunochemotherapy treatment in patients with early-stage, operable triple-negative breast cancer and SOC alone. The primary endpoint is the pathological complete response rate for the combination and the SOC alone. pCR is the absence of cancer at the time of surgery in the tumor and nodes. pCR is an FDA accelerated approval endpoint. Clinical evidence is strong that the risk of a patient's cancer returning is significantly reduced when there is a pCR at the time of surgery.  The Swiss Medic and the European Medicines Agency authorized the initiation of the INVINCIBLE-4 Study in Switzerland and France. The SCI led study is also being done in collaboration with Unicancer (UCBG), the French referent cooperative group in breast cancer accredited by the French National Cancer Institute. The expected total enrollment is up to sixty-one (61) patients.

About Intensity Therapeutics

Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies that enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the SOC with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, formerly SAKK, now the Swiss Cancer Institute (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. pCR is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com or review our SEC filings.

Forward-Looking Statements

Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and in the Company's subsequent SEC filings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

Investor Relations Contact:

Justin Kulik
CORE IR
coreirteam@coreir.com
(516) 222-2560

Media Contact:

Matt Cossel
CORE IR
pr@coreir.com

¹ Bloom, Bender, OncoImmunology June 2019
² Thomas_ASCO_2022_poster
³ Shmid_NEJM_2020;

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SOURCE Intensity Therapeutics Inc.

FAQ

What were the reported pCR rates in the INVINCIBLE-4 study for INT230-6 (INTS) as of March 12, 2026?

INT230-6 plus SOC achieved a pCR in 5 of 7 patients (71.4%), while SOC alone showed 2 of 6 (33%). According to the company, one SOC patient remains unevaluated and the analysis is preliminary and ongoing.

Why was INVINCIBLE-4 enrollment paused and what regulatory action was taken (INTS)?

Enrollment was paused in September 2025 due to observed skin irritations in Cohort A. According to the company, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee in early March 2026 to resume enrollment.

How did safety compare between INT230-6 plus SOC and SOC alone in INVINCIBLE-4 (INTS)?

INT230-6 plus SOC had 44% fewer grade 3 or higher adverse events compared with SOC alone. According to the company, Cohort A reported 14 grade 3+ AEs versus 25 in Cohort B through March 2, 2026.

How many patients have been treated in INVINCIBLE-4 and what is total planned enrollment for INTS?

Fourteen patients have been treated to date, seven per cohort, with a planned total enrollment of up to 61 patients. According to the company, additional dosing will resume pending approval of the protocol amendment.

Could the pCR results from INVINCIBLE-4 affect regulatory approval for INT230-6 (INTS)?

A strong pCR could support accelerated or conditional approval, as pCR is an accepted endpoint by FDA and EMA. According to the company, the pCR endpoint may be used by regulators but results remain preliminary and early.