Intensity Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update
Rhea-AI Summary
Intensity Therapeutics (Nasdaq: INTS) reported second quarter 2026 results and a business update. Research and development expenses were $1.8 million versus $1.5 million a year ago, and general and administrative expenses were $1.3 million versus $1.2 million. Net loss widened to $3.0 million from $2.5 million, with six‑month net loss at $5.4 million versus $5.9 million in 2025.
As of June 30, 2026, cash and cash equivalents were $9.5 million. The company established a $60 million at‑the‑market facility in March 2026, raising net proceeds of $1.6 million in Q2 and an additional $1.3 million thereafter. Intensity initiated activities to resume enrollment at selected U.S. sites in its Phase 3 INVINCIBLE‑3 soft tissue sarcoma study under an FDA‑reviewed amended protocol. In the Phase 2 INVINCIBLE‑4 TNBC study, patient treatment restarted with an updated dosing regimen; early data from 14 patients showed a 71% pathological complete response rate with INT230‑6 plus standard of care versus 42% with standard of care alone and a 44% reduction in grade 3 adverse events.
Positive
- INVINCIBLE-4 early efficacy signal: 71% pCR with INT230-6 + SOC vs 42% with SOC alone (14 patients)
- Reduced toxicity in INVINCIBLE-4: 44% fewer grade 3 adverse events with INT230-6 cohort
- Phase 3 INVINCIBLE-3 enrollment activities resumed at selected U.S. sites under FDA-reviewed amended protocol
- Cash balance of $9.5 million as of June 30, 2026
- ATM capital raised: $1.6 million net in Q2 2026, plus $1.3 million net after quarter-end
- Six-month net loss improved to $5.4 million from $5.9 million year over year
Negative
- Q2 2026 net loss increased to $3.0 million from $2.5 million
- Operating expenses rose to $3.1 million from $2.7 million year over year in Q2
- Cash and equivalents declined to $9.5 million from $11.9 million at December 31, 2025
- Company notes INVINCIBLE-3 site activation and enrollment rates are expected to increase only as sufficient funding is obtained
News Explained
The ATM can fund resumed trials through new-share sales, while new issuance can reduce existing holders’ percentage ownership.
Intensity Therapeutics has initiated work to resume limited U.S. enrollment in INVINCIBLE-3 and restarted treatment in INVINCIBLE-4; its ATM has raised
An ATM is a facility for selling new shares gradually in the open market at prevailing prices rather than through one single priced transaction, so the eventual amount issued is not fixed by the facility’s authorization alone.
At
The release says documentation to restart INVINCIBLE-3 in Europe is in progress, making that submission and subsequent site activation a specific checkpoint beyond the currently resumed U.S. activities.
Sources and calculations
- Intensity Therapeutics Q2 2026 results and business update (2026-08-11)
- At-the-market program definition (undated)
- Dilution definition (undated)
- Intensity Therapeutics first-quarter 2026 fundamentals (2026Q1)
- Cash and equivalents vs quarterly operating cash outflow, in days of cash use $10,245,000 / ($1,826,000 / 90) = [object Object]
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 07 | First quarter earnings | Positive | -0.4% | Clinical progress, resumed enrollment plans, financing capacity, and quarterly financial results |
| Mar 27 | Year-end earnings | Positive | -5.8% | Fundraising, clinical data, cash position, and INVINCIBLE-4 enrollment resumption |
| Nov 06 | Third quarter earnings | Positive | -6.2% | Clinical efficacy data, financing update, and INVINCIBLE-4 protocol amendment |
| Aug 07 | Second quarter earnings | Positive | +7.1% | Reduced losses, fundraising, and early INVINCIBLE-4 clinical findings |
| May 13 | First quarter earnings | Negative | -7.0% | Funding constraints, paused sarcoma enrollment, and reduced cash position |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-matched earnings announcements produced negative 24-hour reactions in four of five observed events, with three divergences and two alignments.
Key Terms
pathological complete response medical
at-the-market financial
pharmacovigilance medical
neoadjuvant medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Initiated activities to resume enrollment in a limited number of
U.S . sites in the soft tissue sarcoma Phase 3 INVINCIBLE-3 Study by the third quarter of 2026 - Patient treatment restarted in the presurgical triple negative breast cancer ("TNBC") Phase 2 INVINCIBLE-4 Study
- Cash and cash equivalents of
$9.5 million - Increased business development activities
Conference call begins at 8:00 a.m. Eastern time today
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: August 11, 2026
Time: 8:00 a.m. Eastern Time
Domestic Dial-In: (866) 652-5200
International Dial-In: (412) 317-6060
Webcast URL: https://event.choruscall.com/mediaframe/webcast.html?webcastid=bZ7JyAJE
Business Update
INVINCIBLE-3 Study: Phase 3 open-label, randomized 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 April 2026, the Company initiated activities to resume enrollment in a limited number of
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 July 2026, the Company restarted patient treatment in the INVINCIBLE-4 Study and is currently targeting complete enrollment by the end of 2027. The Company paused new patient enrollment in September 2025 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. In March 2026, a protocol amendment was approved by the Swissmedic and the Swiss Ethics Committee to use a lower drug volume per tumor volume ratio and a single injection of INT230-6 in Cohort A. In August 2026, the Company opened its first site in
Preliminary data from the first 14 patients (seven in each cohort) showed a
Capital Raises
In March 2026, the Company established a
"We are pleased that the capital raised in 2025 and to date in 2026 provides the resources to reinitiate the Phase 3 INVINCIBLE-3 Study. In addition, during the 2025 pause, we evaluated and modified the protocol based on feedback from key investigators and sarcoma thought leaders. The FDA-reviewed amended protocol will first be implemented in select
Second Quarter 2026 Financial Results
Research and development expenses were
General and administrative expenses were
Net loss was
As of June 30, 2026, cash and cash equivalents totaled
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
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
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 controlled 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 with 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 and now the Swiss Cancer Institute (the "INVINCIBLE-4 Study") (NCT06358573), as part of a Phase 2/3 program evaluating INT230-6 followed by SOC immunochemotherapy and 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, 2025 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
justin@coreir.com
(516) 222-2560
Media Contact:
Matt Cossel
CORE IR
PR@coreir.com
Intensity Therapeutics, Inc. | |||||||
Statements of Operations | |||||||
(in thousands, except share and per share amounts) | |||||||
(Unaudited) | |||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
2026 | 2025 | 2026 | 2025 | ||||
Operating expenses: | |||||||
Research and development | $ 1,833 | $ 1,541 | $ 3,028 | $ 3,730 | |||
General and administrative | 1,251 | 1,164 | 2,582 | 2,369 | |||
Total operating expenses | 3,084 | 2,705 | 5,610 | 6,099 | |||
Loss from operations | (3,084) | (2,705) | (5,610) | (6,099) | |||
Other income (expense): | |||||||
Interest income | 77 | 17 | 171 | 33 | |||
Other (expense) income, net | — | 151 | (2) | 182 | |||
Net loss | $ (3,007) | $ (2,537) | $ (5,441) | $ (5,884) | |||
Loss per share, basic and diluted | $ (1.11) | $ (3.36) | $ (2.08) | $ (8.64) | |||
Weighted average number of shares of | 2,706,607 | 754,725 | 2,620,740 | 681,235 | |||
Intensity Therapeutics, Inc. | |||
Balance Sheets | |||
(in thousands) | |||
June 30, 2026 | December 31, 2025 | ||
(Unaudited) | * | ||
Assets | |||
Current assets: | |||
Cash and cash equivalents | $ 9,529 | $ 11,921 | |
Prepaid expenses and other current assets | 1,700 | 788 | |
Total current assets | 11,229 | 12,709 | |
Right-of-use asset, net | 82 | 96 | |
Other assets | 210 | 1,296 | |
Total assets | $ 11,521 | $ 14,101 | |
Liabilities and Stockholders' Equity | |||
Current liabilities: | |||
Accounts payable | $ 1,009 | $ 583 | |
Accrued expenses | 1,203 | 1,532 | |
Lease liability, current portion | 33 | 31 | |
Total current liabilities | 2,245 | 2,146 | |
Lease liability, net of current portion | 62 | 79 | |
Total liabilities | 2,307 | 2,225 | |
Total stockholders' equity | 9,214 | 11,876 | |
Total liabilities and stockholders' equity | $ 11,521 | $ 14,101 | |
*Derived from audited financial statements | |||
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SOURCE Intensity Therapeutics Inc.