Intensity Therapeutics, Inc. Announces Pricing of Public Offering
- Net proceeds will support ongoing clinical trials including INVINCIBLE-3 and INVINCIBLE-4 studies
- Company has successfully enrolled over 200 patients in previous clinical trials
- Significant dilution for existing shareholders with 6.675M new shares being offered
- Low offering price of $0.30 per share indicates potential market weakness
- Additional dilution possible with 1.001M share over-allotment option
Insights
Intensity Therapeutics raises $2M through dilutive offering at $0.30/share to fund clinical trials, signaling significant financial pressure.
Intensity Therapeutics has announced a highly dilutive public offering priced at just
The offering of 6,675,000 shares with an additional over-allotment option of 1,001,250 shares signals substantial dilution for existing shareholders. The timing and pricing of this capital raise suggest the company faced urgent funding needs to continue its clinical programs.
The proceeds are earmarked for specific clinical priorities: reaching data readout in the INVINCIBLE-4 study, continuing treatment for patients already enrolled in the INVINCIBLE-3 study, and general working capital. Notably, the company doesn't mention using funds to complete the Phase 3 INVINCIBLE-3 trial in soft tissue sarcoma, suggesting this limited funding is intended primarily to reach near-term milestones rather than fully fund its pipeline.
Intensity's lead candidate INT230-6 is being evaluated across multiple studies, including a Phase 3 trial in soft tissue sarcoma and a Phase 2/3 program in triple-negative breast cancer. However, this minimal funding raise indicates potential challenges in advancing these programs without additional capital infusions.
The company's decision to raise capital at such unfavorable terms points to limited financing options and suggests investors should closely monitor Intensity's cash runway and future capital needs. This offering appears to be a stopgap measure rather than a comprehensive funding solution for its clinical development program.
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.
ThinkEquity is acting as sole book-running manager for the offering.
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
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any 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 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.