WESTPORT - Intensity Therapeutics, Inc. (Nasdaq: INTS), a clinical-stage 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 reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.
'The second quarter of 2023 was transformative for Intensity Therapeutics, during which, we closed an upsized initial public offering (IPO), priced at top-of-the-range, despite a turbulent biotech capital market environment. The $20.5 million of net proceeds now allows us to further the development of our lead product candidate, INT230-6, into registration studies,' stated Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. 'Notably, in June, our trial investigators presented new data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from the IT-01 phase 1/2 clinical study of INT230-6, either as monotherapy or in combination with ipilimumab in patients with relapsed, refractory and metastatic sarcomas, as well as from the phase 2 INVINCIBLE study of INT230-6 in presurgical breast cancer patients. The data demonstrated that, for all sarcoma patients receiving at least one dose of INT230-6, alone, the median overall survival was 21.3 months, compared to the typical 7 to 10 months in historical phase 1/2 studies. As a result of this compelling data, interest in our novel approach was especially high among the physicians who treat sarcoma, a deadly disease in desperate need of new therapeutic approaches. We intend to submit an Investigational New Drug (IND) application for a phase 3 study of INT-230-6 in soft tissue sarcoma by the end of this year.
'Additionally, Angel Arnaout, M.D., Scientist and Surgical Oncologist at the Ottawa Hospital, and Professor of Surgery at the University of Ottawa was the lead author on the poster reporting INVINCBLE results at ASCO on the use of INT230-6 in early stage breast cancer. Results from Part 2 of our INVINCIBLE study showed high levels of tumor necrosis, expression levels of dendritic cells, macrophages and CD4 T-cells tumor influx, post treatment using INT230-6, when comparing patients treated with drug versus those in the control group. Dr. Arnaout commented on how our new drug may shift the way all cancer patients awaiting surgery are treated. Looking ahead, we expect to report additional data from the INVINCIBLE study by year end and are planning to launch a phase 2/3 program in a presurgical breast cancer setting,' concluded Mr. Bender.
Recent Company Highlights
June 2023: Closed an upsized IPO of 3.9 million shares of common stock at a public offering price of $5.00 per share, representing the top-of-the-range, raising net proceeds of $20.5 million after full 15% over-allotment.
In June: Reported data at ASCO from 29 metastatic sarcoma patients enrolled in the IT-01 study of lead product, INT230-6, a locally delivered potent cytotoxic treatment; data showed extended survival in refractory soft tissue sarcoma subjects by nearly 450 days compared to a synthetic control and that treatment with INT230-6 induced an immune response in sarcoma tumors. Safety data was favorable with the majority of adverse events being low grade.
In June: Presented data at ASCO meeting from the INVINCIBLE study of INT230-6 in presurgical breast cancer, which reported that gene enrichment pathway analysis demonstrated INT230-6 induced signaling in the post-treatment samples, immune priming in historically quiescent breast cancers and induced T-Cell receptor signaling, macrophage markers, and IL-18 and B-Cell Receptor signaling. Previously at ASCO and other oncology conferences, the Company reported that INT230-6 resulted in major pathological reduction in several early breast cancer patients with up to 100% tumor necrosis after one intratumoral (IT) dose.
Completed first drafts of the IT-01 clinical study reports for INT230-6 alone, in combination with Merck's immunotherapy drug pembrolizumab and in combination with Bristol-Myers Squibb's immunotherapy drug, ipilimumab.
Anticipated 2023 Clinical Milestones
Report additional results from IT-01 phase 1/2 clinical trial of INT230-6 involving metastatic sarcomas.
Report additional results from the phase 2 INVINCIBLE study in presurgical breast cancer.
File an Investigational New Drug (IND) application for a phase 3 study of INT230-6 in soft tissue sarcoma.
Finalize the study design and a protocol for a phase 2/3 program in presurgical breast cancer.
Second Quarter 2023 Financial Highlights
Research and Development (R&D) Expenses were $0.9 million for the three months ended June 30, 2023 as compared to $1.4 million for the same period last year. The 38.0% decrease reflects the fact that Study IT-01 and Study IT-02 no longer have patient care costs and the drafting of results is nearly complete. Phase 3 IT-03 in sarcoma and phase 2/3 IT-04 in presurgical breast cancer will continue to incur planning, multiple regulatory filing, manufacturing, study initiation and trial preparation costs in 2023.
General and Administrative (G&A) Expenses were $363,000 for the three months ended June 30, 2023 as compared to $545,000 for the same period in 2022. The decrease is primarily due to the prior year having higher costs relating to SEC filings and IPO expenses. The accounting services and legal costs related to the IPO in 2023 were charged directly to the equity section of the balance sheet as a reduction of additional paid in capital.
Interest Expense for the three months ended June 30, 2023 were $222,000 as compared to $15,000 for the three months ended June 30, 2022. The increase is due to the execution of additional convertible notes in 2023.
Net Operating Loss for the second quarter ended June 30, 2023 was $1.2 million as compared to $1.9 million for the three months ended June 30, 2022.The current quarter includes a non-operating loss of $2.3 million which is the discount from the IPO price that was given to convertible debt holders as part of their agreements.
Cash and Cash Equivalents as of June 30, 2023, were approximately $136,000. After accounting for the total net cash proceeds received following the closing of the IPO, of approximately $20.5 million, the Company expects to have sufficient cash to fund current operations until early in the third quarter of 2025.
About Intensity Therapeutics
Intensity Therapeutics, Inc. is a clinical-stage biotechnology company pioneering a new immune-based approach to treat solid tumor cancers. Intensity leverages its DfuseRx technology platform to create proprietary drug formulations that following direct injection rapidly disperse throughout a tumor and diffuse therapeutic agents into cancer cells. Intensity's product candidates have the potential to induce an adaptive immune response that not only attacks the injected tumor, but also non-injected tumors. The Company's lead product candidate, INT230-6, is in development for the treatment of patients with solid tumors, such as sarcoma and breast cancer. Intensity has a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate INT230-6 with pembrolizumab.
In addition, the Company has a clinical collaboration agreement with Bristol-Myers Squibb to evaluate the combination INT230-6 with Bristol-Myers Squibb's anti-CTLA-4 antibody, ipilimumab. Intensity has also executed agreements with the Ottawa Hospital Research Institute (OHRI) and the Ontario Institute of Cancer Research (OICR) to study INT230-6 in a randomized controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT04781725). Additionally, the Company executed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute's (NCI) Vaccine Branch.
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 expected future plans, development activities, projected milestones, business activities or results. We have based these forward-looking statements on our 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 we make. These risks and uncertainties, many of which are beyond our control, include: the risk that the anticipated milestones in 2023 or beyond may be delayed or not occur or be changed, as well as other risks described in the section entitled 'Risk Factors' in the Company's 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.
Contact:
Michael Miller
Tel: (917)-633-6086
Email: mmiller@rxir.com
INTENSITY THERAPEUTICS, INC. 
