Intensity Therapeutics Highlights 2025 Milestones and Outlines 2026 Strategic Priorities

Rhea-AI Summary

Intensity Therapeutics (Nasdaq: INTS) reviewed 2025 progress and outlined 2026 priorities focused on clinical development and capital discipline. Key 2025 highlights include a peer-reviewed publication reporting a 75% disease control rate and median overall survival of 11.9 months (and 21.3 months in a sarcoma subset), Phase 2 INVINCIBLE-4 safety observations with 50% fewer grade 3+ adverse events versus neoadjuvant chemo in early data, and initiation of a protocol amendment to revise dosing.

The company raised over $20 million in 2025, extending operating runway into Q2 2027, paused Phase 3 INVINCIBLE-3 enrollment after 21 patients due to funding, and plans to seek additional capital and partner discussions in 2026.

Positive

• Peer-reviewed publication reporting 75% disease control rate
• Median overall survival 11.9 months (21.3 months sarcoma subset)
• Raised over $20 million, runway into Q2 2027
• Phase 2 safety: 50% fewer grade 3+ adverse events observed

Negative

• Phase 3 INVINCIBLE-3 enrollment paused after 21 patients due to funding
• INVINCIBLE-4 enrollment temporarily paused for dosing revision
• Reinitiation of trials contingent on obtaining sufficient incremental funding

News Market Reaction

+1.38%

4 alerts

+1.38% News Effect

+12.6% Peak Tracked

+$342K Valuation Impact

$25M Market Cap

1.0x Rel. Volume

On the day this news was published, INTS gained 1.38%, reflecting a mild positive market reaction. Argus tracked a peak move of +12.6% during that session. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $342K to the company's valuation, bringing the market cap to $25M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Patients treated INVINCIBLE‑4: 14 patients INVINCIBLE‑4 target size: 61 patients INVINCIBLE‑3 enrollment: 21 patients +5 more

8 metrics

Patients treated INVINCIBLE‑4 14 patients Phase 2 presurgical TNBC study, 7 in each cohort

INVINCIBLE‑4 target size 61 patients Planned total after adding seven patients to Cohort A

INVINCIBLE‑3 enrollment 21 patients Phase 3 soft tissue sarcoma study before enrollment pause

Grade 3+ adverse events 50% fewer INT230‑6 cohort vs standard neoadjuvant chemotherapy in INVINCIBLE‑4

Disease control rate 75% Phase 1/2 INT230‑6 study in advanced solid tumors (eBioMedicine publication)

Sarcoma median OS 21.3 months Subset of sarcoma patients in Phase 1/2 INT230‑6 study

Abscopal effects rate At least 20% of patients Patients receiving >40% of total tumor burden with INT230‑6

Capital raised 2025 Over $20 million gross proceeds Two public offerings, one registered direct, and ATM issuances

Market Reality Check

Price: $0.3490 Vol: Volume 887,439 vs 20-day ...

low vol

$0.3490 Last Close

Volume Volume 887,439 vs 20-day average 1,667,172 (relative volume 0.53) ahead of this update. low

Technical Shares at 0.4122, trading below the 200-day MA of 0.52 and far under the 3.1663 52-week high.

Peers on Argus

INTS slipped -0.79% while peers were mixed: ERNA up 1.56%, LYRA up 3%, MBRX down...

INTS slipped -0.79% while peers were mixed: ERNA up 1.56%, LYRA up 3%, MBRX down 0.49%, BOLT and SNSE flat. Moves do not indicate a coordinated sector reaction.

Historical Context

5 past events · Latest: Dec 11 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 11	Clinical data update	Positive	+7.3%	Breast cancer symposium posters with early INVINCIBLE‑4 safety efficacy observations.
Dec 05	Listing compliance	Positive	+10.2%	Nasdaq granted 180‑day extension to regain <b>$1.00</b> minimum bid compliance.
Dec 04	Conference presentations	Positive	+13.0%	Announcement of two SABCS 2025 presentations on INT230‑6 and anthracycline‑sparing concepts.
Nov 06	Earnings and update	Negative	-14.9%	Q3 2025 results with going concern language and paused INVINCIBLE‑3 and INVINCIBLE‑4 enrollment.
Oct 31	Equity offering	Negative	-44.7%	Pricing of <b>$4.0M</b> registered direct offering at <b>$0.80</b> per share for trial funding.

Pattern Detected

Across the last five tracked events, price reactions consistently moved in the same direction as the apparent news tone, with no clear cases of divergence.

Recent Company History

Over recent months, Intensity combined clinical progress with balance-sheet driven activity. A $4.0M registered direct offering and ongoing ATM usage funded programs but coincided with a -44.68% reaction to the October offering. Q3 2025 results highlighted cash of $7.1M and an extended runway to the end of Q1 2027, but also paused Phase 3 and Phase 2 studies due to funding and dosing changes. Multiple San Antonio Breast Cancer Symposium presentations in December 2025, covering 14 INVINCIBLE‑4 patients and reduced high‑grade events, drew positive single‑day reactions. Today’s milestone and strategy update builds directly on those trial and financing themes.

Market Pulse Summary

This announcement consolidates Intensity’s 2025 progress and its 2026 focus on INT230‑6, highlightin...

Analysis

This announcement consolidates Intensity’s 2025 progress and its 2026 focus on INT230‑6, highlighting a 75% disease control rate and a sarcoma median overall survival of 21.3 months from a Lancet‑family journal publication. It details safety improvements in the 14‑patient INVINCIBLE‑4 study and a plan to expand it to 61 patients, while INVINCIBLE‑3 remains paused after 21 enrollments pending funding. Investors may track future enrollment restarts, additional peer‑reviewed publications, and capital‑raising steps as key milestones.

Key Terms

pathological complete response, standard of care, triple-negative breast cancer, neoadjuvant, +4 more

8 terms

pathological complete response medical

"In September 2025, a pathological complete response was observed in the first patient..."

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.

standard of care medical

"INT230-6 given before administration of the standard of care ("SOC") treatment..."

Standard of care is the accepted medical treatment or clinical approach that most qualified doctors would use for a given condition today, based on available evidence, guidelines and common practice. For investors, it acts like the baseline product customers expect: a new therapy or device must match or improve on the standard of care to win market share, gain reimbursement and limit legal or regulatory risk.

triple-negative breast cancer medical

"patients with early-stage, operable triple-negative breast cancer and SOC alone."

Triple-negative breast cancer is a type of breast cancer that lacks three common markers used to identify and treat the disease effectively. Because it doesn’t respond to some targeted therapies, it can be more difficult to treat and may have a more aggressive progression. This impacts the development of new treatments and can influence the outlook for healthcare companies involved in cancer research and pharmaceuticals.

neoadjuvant medical

"compared to the standard of care neoadjuvant chemotherapy alone cohort."

"Neoadjuvant" describes treatments or interventions that are given before the main or primary procedure, such as surgery or a major decision. It’s like preparing the ground before planting seeds, aiming to improve the final outcome. For investors, understanding neoadjuvant approaches can provide insight into how companies enhance results or effectiveness in their processes or products.

anthracyclines medical

"using biomarkers to assess the need for anthracyclines (doxorubicin)..."

Anthracyclines are a class of chemotherapy drugs used to treat many types of cancer; they work by damaging the genetic material inside fast-growing cells, roughly like cutting power lines to stop a factory from running. They matter to investors because their strong effectiveness is balanced by well-known safety risks—especially potential heart damage—which drives regulation, treatment guidelines, development costs, generic competition, and market demand for safer alternatives.

doxorubicin medical

"assess the need for anthracyclines (doxorubicin) for the treatment..."

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.

abscopal effects medical

"At least 20% of patients... had abscopal effects where uninjected tumors shrank."

Abscopal effects are a rare medical phenomenon where a local cancer treatment, most often radiation aimed at a specific tumor, appears to trigger shrinkage of tumors elsewhere in the body that were not directly treated. For investors, this matters because reliable induction of abscopal responses could turn localized therapies into systemic treatments, potentially changing clinical value, market size, and regulatory pathways for oncology products—like a local spark setting off a wider fire that treats disease beyond the target site.

pharmacovigilance medical

"maintain the database, conduct pharmacovigilance, and conduct other study-related activities..."

Pharmacovigilance is the process of monitoring and assessing the safety of medicines after they are on the market, ensuring that any side effects or risks are identified and managed. For investors, it matters because it helps ensure that pharmaceutical companies maintain safe products, which can influence a company’s reputation, regulatory approval, and financial stability over time.

AI-generated analysis. Not financial advice.

Peer-reviewed clinical validation, strengthened balance sheet, and disciplined execution position the Company for 2026

SHELTON, Conn., Jan. 13, 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, today highlights key milestones achieved during 2025 and outlines strategic priorities for 2026.

2025 Key Highlights and 2026 Outlook and Strategic Priorities

• INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care ("SOC") treatment in patients with early-stage, operable triple-negative breast cancer and SOC alone.
  • In September 2025, a pathological complete response was observed in the first patient evaluated in Cohort A, where each patient receives one or two doses of INT230-6 eight days apart, followed by the SOC.  Some patients in Cohort A began to experience localized skin irritation, prompting a temporary pause in new patient enrollment.  As a result, the protocol is being modified to administer one or two doses at lower volumes for each tumor size. 
    
    
  • In December 2025, early observations data from the INVINCIBLE-4 Study were presented at the San Antonio Breast Cancer Symposium, showing favorable safety, with 50% fewer grade 3 or higher adverse events observed in the INT230-6 cohort compared to the standard of care neoadjuvant chemotherapy alone cohort. The INVINCIBLE-4 study was initiated in late 2024, and 14 patients have been treated, with 7 in each cohort. 
    
    
  • The Company plans to file a protocol amendment with the regulatory agencies for this revision in dosing in the first quarter of 2026, and expects to reinitiate enrollment for the now 61-patient study in the first quarter of 2026, as seven additional patients will be added to cohort A.
• INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes. 
  • In March 2025, the Company paused new site activations and patient enrollments due to funding constraints. Before this pause, the trial had enrolled 21 patients. The Company continues to treat patients enrolled in this study, maintain the database, conduct pharmacovigilance, and conduct other study-related activities in cooperation with its third-party contract research organizations at significantly reduced ongoing costs during this pause.
    
    
  • The Company has prioritized reinitiating patient enrollment and site activations during 2026 once sufficient funding is obtained. 
• Potential New Phase 3 Breast Cancer Study: The clinical study could be with INT230-6 plus standard of care, potentially also using biomarkers to assess the need for anthracyclines (doxorubicin) for the treatment of neoadjuvant Triple Negative Cancer (assuming sufficient funding has already been obtained for the reinitiation of the Phase 3, sarcoma INVINCIBLE-3 Study).
  • If safety and efficacy trends continue in the INVINCIBLE-4 Study, a Phase 3 clinical study design in the US and other countries using INT230-6 with the current standard of care may be initiated contingent on obtaining sufficient incremental funding.
• Peer-Reviewed Publication in a Lancet journal: Validate Clinical Potential
  • In October 2025, Intensity announced publication of its Phase 1/2 clinical study evaluating INT230-6 in the Lancet Discovery Science journal, eBioMedicine (volume 121). The manuscript reported a 75% disease control rate and a median overall survival of 11.9 months in patients with advanced solid tumors, with a median overall survival of 21.3 months observed in a subset of sarcoma patients. At least 20% of patients receiving a dose greater than 40% of their total tumor burden had abscopal effects where uninjected tumors shrank.  Exploratory analyses further demonstrated potential to improve disease control rates and overall survival, especially when treating higher percentages of tumor burden. There was also evidence of systemic immune engagement, reinforcing INT230-6's differentiated mechanism of action.
    
    
  • During 2026, the Company will continue to pursue an aggressive peer-reviewed publications strategy for its completed metastatic and breast cancer studies.
• Strengthened Balance Sheet, Extended Runway into the Second Quarter of 2027:
  • The Company raised over $20 million in gross proceeds during 2025 through two public offerings, one registered direct offering, and ATM issuances. These successful capital-raising efforts strengthened Intensity's balance sheet and extended its current operating runway into the second quarter of 2027, providing flexibility to advance certain clinical programs without near-term financing pressure.
    
    
  • The Company plans to maintain a disciplined operating approach in 2026 and will seek to opportunistically raise additional capital during 2026 to reinitiate patient enrollment and site activations in the INVICIBLE-3 Study, and to potentially initiate a new Phase 3 Breast Cancer Study.

• Business Development: Continuing to pursue discussions with potential pharmaceutical partners to potentially accelerate the development and commercialization of our new drug.

Intensity Therapeutics Founder, President, and CEO Lewis H. Bender stated, "We enter our next phase of development with a clinically validated scientific foundation and a capital position that supports disciplined execution. A peer-reviewed publication in eBioMedicine, a Lancet Discovery Science journal, reinforced the clinical potential of INT230-6. At the same time, our successful capital raising efforts provided the resources to advance our programs well into 2027. Our focus remains on generating high-quality clinical data, additional peer-review publications, advancing regulatory engagement, and allocating capital with intention as we progress INT230-6 across multiple development pathways, in an attempt to build long-term shareholder value through consistent execution."

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 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.

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 did Intensity Therapeutics (INTS) report about the 2025 peer-reviewed publication?

The October 2025 Lancet Discovery Science publication reported a 75% disease control rate and median overall survival of 11.9 months, with 21.3 months in a sarcoma subset.

How much capital did INTS raise in 2025 and how long is the runway?

Intensity raised over $20 million in 2025, extending its operating runway into Q2 2027.

Why was the Phase 3 INVINCIBLE-3 (INT230-6) enrollment paused in 2025?

Enrollment and new site activations were paused in March 2025 due to funding constraints after 21 patients had enrolled.

What safety signal did INVINCIBLE-4 early data show for INT230-6 in December 2025?

Early observations showed 50% fewer grade 3 or higher adverse events in the INT230-6 cohort versus neoadjuvant chemotherapy cohort.

When does INTS expect to reinitiate INVINCIBLE-4 enrollment and what changes are planned?

The company plans a protocol amendment in Q1 2026 to reduce per-dose volumes and expects to reinitiate enrollment in Q1 2026 for the 61-patient study.

Will Intensity initiate a new Phase 3 breast cancer study and what is required?

A Phase 3 breast cancer study may be initiated if safety/efficacy trends continue and sufficient incremental funding is obtained.