Intensity Therapeutics, Inc. to Present Two Posters at the 2025 San Antonio Breast Cancer Symposium

Rhea-AI Summary

Intensity Therapeutics (Nasdaq: INTS) will present two posters at the 2025 San Antonio Breast Cancer Symposium on Dec 12 and Dec 11, 2025 describing early clinical observations and a potential Phase 3 design for INT230-6 in triple negative breast cancer (TNBC).

Key facts: INVINCIBLE-4 is a randomized presurgical Phase 2 trial (NCT06358573) activated in 2024 with 14 patients treated (7 per cohort). Through Nov 10, there were 9 grade ≥3 events in the INT230-6 plus SOC cohort vs 20 in SOC alone. Protocols are being modified to a single, lower-volume dose to address tumor necrosis observed after two doses. A Phase 3 concept may compare INT230-6+SOC, SOC, and INT230-6+SOC without anthracycline.

Positive

• INVINCIBLE-4 treated 14 patients (7 per cohort)
• Grade ≥3 adverse events: 9 vs 20 (INT230-6+SOC vs SOC)
• Protocol change to single lower-volume dose to reduce necrosis

Negative

• Some patients showed tumor skin/adipose necrosis after two doses requiring more surgery
• Safety observations prompted dosing restriction before continuing enrollment

Key Figures

Patients treated 14 patients INVINCIBLE-4 Phase 2 TNBC trial; 7 per cohort as of Nov 10, 2025

Cohort size 7 patients INT230-6 plus standard of care cohort (Cohort A)

Cohort size 7 patients Standard of care alone cohort (Cohort B)

Grade ≥3 adverse events 9 events INT230-6 plus standard of care cohort through Nov 10, 2025

Grade ≥3 adverse events 20 events Standard of care alone cohort through Nov 10, 2025

Safety comparison 50% fewer grade ≥3 AEs INT230-6 cohort vs neoadjuvant chemotherapy standard of care alone

Tumor size example 2.2 cm Patient tumor diameter receiving one INT230-6 dose with skin irritation

Trial phase Phase 2 INVINCIBLE-4 randomized presurgical TNBC study

Market Reality Check

$0.5500 Last Close

Volume Volume 4,171,197 vs 20-day average 4,011,740 is slightly above typical trading activity. normal

Technical Shares at $0.55 are trading below the 200-day moving average of $0.71 and far under the $3.1663 52-week high.

Peers on Argus

INTS gained 4.3% while peers showed mixed moves: ERNA -0.78%, MBRX -14.81% vs LYRA +2.81%, BOLT +2.86%, SNSE +7.12%, suggesting a stock-specific reaction rather than a uniform biotech move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 05	Nasdaq compliance update	Neutral	+10.2%	Nasdaq granted 180-day extension to regain $1.00 minimum bid compliance.
Dec 04	Conference presentations	Positive	+13.0%	Announcement of two SABCS posters detailing INT230-6 data and concepts.
Nov 06	Earnings and update	Negative	-14.9%	Q3 results with limited cash, trial pauses, and going-concern language.
Oct 31	Equity offering	Negative	-44.7%	$4.0M registered direct offering of common stock under Form S-3.
Oct 30	Clinical data publication	Positive	+394.6%	eBioMedicine publication of INT230-6 phase 1/2 data with favorable survival and safety.

Pattern Detected

Recent price reactions generally tracked news tone: strong gains on positive clinical updates, sharp drops on dilutive offerings, and declines on funding/going-concern disclosures.

Recent Company History

Over the last few months, Intensity Therapeutics has alternated between clinical progress and financing pressure. On Oct 30, 2025, publication of positive INT230-6 phase 1/2 data drove a large gain. A $4.0 million registered direct offering on Oct 31 triggered a sharp selloff, followed by Q3 results on Nov 6 highlighting cash runway but going-concern risk. Early December brought SABCS presentation announcements and a Nasdaq bid-price extension, both met with modest gains. Today’s SABCS safety update for INVINCIBLE-4 builds directly on those earlier clinical disclosures.

Market Pulse Summary

This announcement highlights early INVINCIBLE-4 safety data showing fewer severe adverse events with INT230-6 plus standard of care in 14 triple negative breast cancer patients, and outlines concepts for a potential Phase 3 trial, including anthracycline-sparing arms. It builds on prior INT230-6 survival data published on Oct 30, 2025 and recent SABCS presentation plans. Investors may watch enrollment restart timing, evolving safety trends, and any future regulatory discussions about using pCR as a surrogate endpoint.

Key Terms

triple negative breast cancer medical

"Clinical Trial for Triple Negative Breast Cancer continue to show favorable safety"

Triple negative breast cancer is a type of breast cancer that lacks three common markers used to identify and target the disease, making it more challenging to treat. It tends to grow and spread more quickly than other forms, which can lead to more aggressive outcomes. Its complexity can impact medical research and treatment developments, influencing investor interest in healthcare companies working on new therapies.

neoadjuvant chemotherapy medical

"compared to the Standard of Care ("SOC") neoadjuvant chemotherapy alone cohort"

Neoadjuvant chemotherapy is drug treatment given before the main medical procedure—typically surgery—to shrink a tumor or reduce disease burden so the main treatment can work better. For investors, it matters because success or failure can change a therapy’s market potential, affect clinical trial outcomes and approval chances, and influence downstream use of a drug across more patients, similar to how a primer improves paint adhesion before a major renovation.

anthracycline medical

"with and without the toxic anthracycline, doxorubicin"

An anthracycline is a type of powerful medicine used to treat cancer, working by killing or stopping the growth of cancer cells. Because these drugs can have significant side effects and influence healthcare costs, they are closely watched by investors, especially in the pharmaceutical and healthcare sectors. Their development and use can impact the financial performance of companies involved in cancer treatment.

doxorubicin medical

"without anthracycline compounds such as doxorubicin, a highly cardiotoxic agent"

Doxorubicin is a widely used chemotherapy drug that kills rapidly dividing cancer cells by interfering with their ability to copy genetic material, somewhat like gumming up the photocopier so abnormal cells cannot reproduce. For investors, doxorubicin matters because its clinical effectiveness, safety profile, patent status, manufacturing capacity, and pricing directly affect drugmakers’ revenue, regulatory risk, and demand for related therapies or alternative treatments.

intratumoral medical

"Intratumoral Injections of INT230-6 Prior to Neoadjuvant Immuno-chemotherapy"

"Intratumoral" describes something that occurs or exists within a tumor, which is an abnormal growth of tissue. For investors, understanding intratumoral is important because it relates to medical treatments or research aimed at targeting the tumor directly, potentially leading to more effective therapies. Think of it as focusing treatment straight into the problem area, much like fixing a leak by working directly on the pipe itself.

immunochemotherapy medical

"when our drug is combined with SOC immunochemotherapy"

Immunochemotherapy is a cancer treatment approach that combines drugs that stimulate a patient’s immune system with traditional cancer-killing drugs, aiming to attack tumors from two directions at once. Investors care because success or failure in trials, safety profiles, and regulatory approval can sharply change a therapy’s commercial potential and a company’s valuation—think of it as pairing two tools to improve chances of fixing a problem but also increasing complexity and risk.

AI-generated analysis. Not financial advice.

• Poster PS5-08-16 Reports Early Observations from the INVINCIBLE-4 Study, an Ongoing Randomized, Presurgical Phase 2 Clinical Trial for Triple Negative Breast Cancer continue to show favorable safety
  • 50% fewer grade 3 or higher Adverse Events were observed in the INT230-6 cohort compared to the Standard of Care ("SOC") neoadjuvant chemotherapy alone cohort.
• Poster PS4-10-15 Describes An Overview of a Potential Phase 3 Clinical Study Design with INT230-6 plus standard of care with and without the toxic anthracycline, doxorubicin

SHELTON, Conn., Dec. 11, 2025 /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, announces it will present two posters  at the San Antonio Breast Cancer Symposium ("SABCS"), in San Antonio, TX being held at the Henry B. Gonzalez Convention Center.

On Friday, December 12, 2025 at 12:30 PM CST, Andreas Müller, M.D., from the Department of Medicine at the Kantonsspital Winterthur, Switzerland and Head of the Breast Center will present on behalf of the Swiss Cancer Institute abstract #1589 PS5-08-16, titled, Intratumoral Injections of INT230-6 Prior to Neoadjuvant Immuno-chemotherapy in Early-Stage Triple Negative Breast Cancer (TNBC): Early observations from INVINCIBLE-4-SAKK 66/22 (NCT06358573), a Phase II Randomized Clinical Trial. Today, December 11, 2025 at 5 PM CST, Lewis H. Bender, M.S., M.A., M.B.A., Intensity Therapeutics Founder, President and CEO, will present abstract #801 Poster PS4-10-15, titled, Accelerating an Anthracycline-Free Future: A New Drug in Clinical Testing Offers Patients Hope for Safer, More Effective Breast Cancer Therapy Combinations.

INVINCIBLE-4 Study Observations 

The INVINCIBLE-4 study was activated in 2024. Fourteen patients have been treated to date with 7 in each cohort.  Observations to date include the following: 

• The safety data for the patients who received INT230-6 plus SOC ("Cohort A"), continues to be favorable compared to the standard of care ("SOC") alone ("Cohort B")
  • Seven patients have been treated per cohort (14 patients total); there were nine grade 3 or higher adverse events in the INT230-6 plus SOC and 20 events in the SOC alone through November 10^th (see Figure below)

				Cohort A - Experimental						Cohort B - SOC
				(N=7)						(N=7)
SOC		Term		Grade 3		Grade 4		Overall		Grade 3		Grade 4		Overall
Blood and Lymphatic System Disorders		Anemia								1 (14.3 %)				1 (14.3 %)
		Febrile neutrogenia		2 (28.6 %)				2 (28.6 %)		2 (28.6 %)				2 (28.6 %)
Ear and Labyrinth Disorders		Vertigo								1 (14.3 %)				1 (14.3 %)
General Disorders and Administration Site Conditions		Fatigue								1 (14.3 %)				1 (14.3 %)
		Injection Site Reaction		4 (57.1 %)				4 (57.1 %)
Infections and Infestations		Catheter Related Infection								1 (14.3 %)				1 (14.3 %)
		Infected Seroma								1 (14.3 %)				1 (14.3 %)
		Skin Infection								1 (14.3 %)				1 (14.3 %)
		Urinary Tract Infection		1 (14.3 %)				1 (14.3 %)
Investigation		Alanine Aminotransferase Increased								1 (14.3 %)				1 (14.3 %)
		Creatinine Increased								1 (14.3 %)				1 (14.3 %)
		GGT Increased								1 (14.3 %)				1 (14.3 %)
		Neutrophil Count Decreased				2 (28.6 %)		2 (28.6 %)		1 (14.3 %)		2 (28.6 %)		3 (42.9 %)
Metabolism and Nutrition Disorders		Anorexia								1 (14.3 %)				1 (14.3 %)
Neoplasms Benign, Malignant and Unspecified (incl. Cysts and Polyps)		Disease Progression								1 (14.3 %)				1 (14.3 %)
Nervous System Disorders		Guillain-Barre Syndrome								1 (14.3 %)				1 (14.3 %)
		Imunotherapy Related Encephalitis										1 (14.3 %)		1 (14.3 %)
Renal and Urinary Disorders		Chronic Kidney Disease								2 (28.6 %)				2 (28.6 %)
TOTAL				7		2		9		17		3		20

A patient with a 2.2 cm tumor who received one dose of INT230-6 showed skin irritation at the time of surgery. However, skin and adipose tissue necrosis on MRI scans were observed in some patients who received two doses, thereby requiring more surgery.  As a result, the protocol is being modified to administer a single dose at lower volumes for each tumor size.  If tumor necrosis is observed on MRI after the first dose of INT230-6 prior to the start of SOC, then a second dose will not be made.

Potential Phase 3 Clinical Study Design

If safety and efficacy trends continue in the INVINCIBLE-4 Study, a Phase 3 clinical study design may include a treatment arm using INT230-6 and SOC without anthracycline compounds such as doxorubicin, a highly cardiotoxic agent.  Doxorubicin is often referred to by patients and physicians as "the red devil" because of its red color and harsh effects.

In today's presentation, Mr. Bender discusses a potential Phase 3 clinical study concept using INT230-6 with SOC with and without doxorubicin compared to SOC alone . Currently, the SOC treatment includes immunotherapy (pembrolizumab), an anthracycline (usually doxorubicin), carboplatin, cyclophosphamide, and taxane. Depending on the strength of the pCR data from the INVINCIBLE-4 Study and a lead-in cohort of patients in a potential Phase 3 trial, a three-arm randomized, controlled Phase 3 trial could be 1) INT230-6 with SOC, 2) current SOC, and 3) INT230-6 with SOC without the anthracycline.

Christine Handy, a patient advocate and co-author on the poster number PS4-10-15 noted, "I have experienced permanent cardiotoxicity using the red devil, doxorubicin, when treated for my breast cancer and know full well how that agent can disrupt the lives and health of those fighting cancer. Patients can be harmed by the treatment for this potentially deadly disease and often have to make a difficult choice as some fear the harmful effects of therapy as much as the cancer itself. I am encouraged by companies such as Intensity Therapeutics with new concepts for improving safety and efficacy for patients and am excited by the early observations of this new and novel drug treatment."

Mr. Bender concluded, "Triple Negative Breast Cancer is one of the most aggressive and difficult to treat breast cancer subtypes. While our INVINCIBLE-4 Study is still early, we are encouraged by the observed safety as reported in the PS5-8-16 poster and pCR results received to date when our drug is combined with SOC immunochemotherapy. These new safety results are consistent with the data from pre-clinical and clinical data when our drug is combined with immunotherapies.  We look to restart patient enrollment in INVINCIBLE-4 study using the modified dosing regimen to improve our results as soon as possible. Should the safety and pCR results remain favorable, we plan to approach regulatory authorities with a Phase 3 study design that could yield a safer, more effective presurgical dosing regimen with good cosmetic outcomes for patients. Subject to regulatory agreement, using pCR as the surrogate endpoint could allow for an accelerated approval of a TNBC regimen without the red devil in a timeframe sooner than current trials that are evaluating event free survival."

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 recurrence.  Approximately 11-17% 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, the majority 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 immune/chemotherapy 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 are 65%, with rates generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 80% 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 U.S Food and Drug Administration ("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. Pathological complete response ("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 complete 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 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 standard of care ("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. Pathological complete response ("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.

About Christine Handy

Christine Handy is an American model, author, motivational speaker, Executive producer and breast cancer survivor. She has been a print model for over 40 years. Handy was diagnosed with an aggressive form of breast cancer on October 1, 2012. She experienced 28 rounds of chemotherapy and a double mastectomy. Handy's 2016 novel Walk Beside Me is a fictionalized story of the ordeal of a successful model who receives a breast cancer diagnosis and several rounds of chemotherapy using doxorubicin. It was a national bestseller. In May of 2025, the independent film, Hello Beautiful, based on Christine's life, won the Golden Palm Best Picture Award at the prestigious and influential 25th Annual Beverly Hills Film Festival.

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

 

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SOURCE Intensity Therapeutics Inc.

FAQ

What early safety results did INTS report from the INVINCIBLE-4 Phase 2 trial as of Dec 11, 2025?

INVINCIBLE-4 (14 patients) reported 9 grade ≥3 events in INT230-6+SOC vs 20 in SOC alone through Nov 10, 2025.

How many patients have been treated in INTS INVINCIBLE-4 study (NCT06358573)?

Fourteen patients have been treated to date, with 7 patients per cohort.

Why is Intensity modifying the INT230-6 dosing regimen in INVINCIBLE-4?

Tumor skin and adipose necrosis was observed after two doses, so the protocol shifts to a single, lower-volume dose per tumor size.

What Phase 3 design is Intensity proposing for INT230-6 and when could it proceed?

A three-arm randomized Phase 3 concept could compare INT230-6+SOC, SOC, and INT230-6+SOC without anthracycline, conditional on continued favorable safety and pCR trends.

What does the INVINCIBLE-4 safety comparison mean for INTS shareholders?

Early data show fewer grade ≥3 events in the INT230-6 arm (9 vs 20), which the company frames as a favorable safety trend for potential development.

When and where will Intensity present its SABCS posters describing INVINCIBLE-4 and Phase 3 plans?

Posters are presented at the 2025 San Antonio Breast Cancer Symposium: abstract #1589 PS5-08-16 on Dec 12, 2025 at 12:30 PM CST and abstract #801 PS4-10-15 on Dec 11, 2025 at 5:00 PM CST.