Intensity Therapeutics, Inc. Announces Proposed Public Offering of Common Stock

Rhea-AI Summary

Intensity Therapeutics (NASDAQ: INTS), a late-stage biotech company developing novel intratumoral cancer therapies, has announced a proposed public offering of common stock. ThinkEquity will serve as the sole book-running manager. The proceeds will fund patient enrollment and data readout for the INVINCIBLE-4 Study, support existing patients in the INVINCIBLE-3 Study, and provide working capital. The offering will be made through a shelf registration statement on Form S-3. Intensity's lead drug, INT230-6, has shown promising results in clinical trials, demonstrating ability to kill tumors and elicit immune responses within days of injection. The company has completed two clinical studies with over 200 patients and is currently conducting Phase 3 trials in soft tissue sarcoma and Phase 2 studies in triple-negative breast cancer.

Positive

• Company has advanced clinical pipeline with over 200 patients treated across multiple studies
• Lead drug INT230-6 demonstrates rapid tumor-killing ability and immune response activation
• Proceeds will support advancement of Phase 3 and Phase 2 clinical trials
• Company has active shelf registration statement in place for efficient fundraising

Negative

• Offering will likely cause dilution for existing shareholders
• Company requires additional funding before generating product revenues
• Faces risks of clinical trial failures and regulatory challenges
• Ongoing cash burn requires external financing for operations

Insights

Biotech Investment Analyst

Intensity Therapeutics plans to raise capital through a public stock offering to fund ongoing clinical trials for its cancer immunotherapy platform.

Intensity Therapeutics (INTS) has announced plans for a secondary public offering of common stock, signaling a strategic move to strengthen its financial position. This capital raise comes at a critical juncture as the company advances multiple clinical programs testing its novel intratumoral cancer therapy, INT230-6.

The proceeds will specifically support two key clinical initiatives: funding patient enrollment and data collection for the INVINCIBLE-4 Study (evaluating INT230-6 in presurgical triple-negative breast cancer) and continuing treatment for existing patients in the INVINCIBLE-3 Study (a Phase 3 trial in soft tissue sarcoma). The offering will be managed by ThinkEquity as the sole book-runner.

This financing approach is typical for late-stage biotech companies with promising candidates but significant cash requirements to complete pivotal trials. Intensity's technology platform delivers cytotoxic agents directly into tumors to kill cancer cells while simultaneously activating immune responses – potentially addressing limitations of conventional immunotherapies.

The company has already enrolled over 200 patients across multiple studies, demonstrating commitment to advancing its clinical program. The Phase 3 INVINCIBLE-3 Study with overall survival as an endpoint represents the most advanced stage of development and will require substantial resources to complete.

For investors, this offering represents dilution of existing shares but provides essential funding for the company's late-stage clinical development strategy. The company's ability to successfully raise capital will determine its runway to reach critical data readouts that could validate its therapeutic approach in difficult-to-treat cancers.

SHELTON, Conn., June 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, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, today announced that it intends to offer to sell shares of its common stock in an underwritten public offering. All of the shares of common stock are to be sold by the Company.

ThinkEquity is acting as sole book-running manager for the offering.

The Company intends to use the net proceeds from the offering for the enrollment of patients and to reach data read out in the INVINCIBLE-4 Study, for the treatment of existing patients enrolled in the INVINCIBLE-3 Study, and for working capital and general corporate purposes.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-280681), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 3, 2024 and declared effective on July 11, 2024. The offering will be made only by means of a written prospectus and related prospectus supplement. A preliminary prospectus supplement and accompanying prospectus describing the terms of the offering has been or will be filed with the SEC on its website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41^st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such preliminary prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

About Intensity Therapeutics, Inc:

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 the investigational new drug, 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 and 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, SAKK (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

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 completion of the public offering on the anticipated terms or at all, the Company's intended use of proceeds from the offering, 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 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; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company may not satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; and other risks described in the section entitled "Risk Factors" in the Company's preliminary prospectus supplement to be filed with the SEC, 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.

For Investor Relations Inquiries:

Investor Relations Contact:
Justin Kulik
Justin@coreir.com
CORE IR
(516) 222-2560

Media Contact:
Jules Abraham
CORE IR
pr@coreir.com

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SOURCE Intensity Therapeutics Inc.

FAQ

What is the purpose of Intensity Therapeutics' (INTS) stock offering in June 2025?

The offering aims to fund patient enrollment in the INVINCIBLE-4 Study, support existing INVINCIBLE-3 Study patients, and provide working capital for general corporate purposes.

What is Intensity Therapeutics' (INTS) main product and how does it work?

INT230-6 is their lead drug, which uses engineered chemistry to deliver cytotoxic drugs directly into tumors, killing cancer cells and stimulating immune responses within days of injection.

How many clinical trials has Intensity Therapeutics (INTS) completed and what are their current studies?

They completed two clinical studies with over 200 patients and are currently conducting a Phase 3 trial in soft tissue sarcoma and a Phase 2 study in triple-negative breast cancer.

Who is the underwriter for Intensity Therapeutics' (INTS) public offering?

ThinkEquity is acting as the sole book-running manager for the offering.

What are the key risks associated with Intensity Therapeutics' (INTS) stock offering?

Key risks include potential shareholder dilution, need for additional funding before revenue generation, clinical trial failure risks, and ongoing cash burn requiring external financing.