Full Press Release Details
Intensity Therapeutics Reports Third Quarter
Financial Results and Provides Corporate Update
Presented positive Phase 1/2 clinical data for
INT230-6 in patients with refractory soft tissue sarcoma at Connective Tissue Oncology Society ("CTOS"), demonstrating 93%
disease control rate in patients on monotherapy and survival extension of nearly 15 months vs. synthetic control group
Received Orphan Drug Designation for the three
components of INT230-6 for the treatment of soft tissue sarcoma
Closed upsized IPO and full exercise of over-allotment
option for $20.2 million in net proceeds
On track to file IND for Phase 3 study of INT230-6
in soft tissue sarcoma and to report additional Phase 2 INVICIBLE study results for presurgical breast cancer by end of 2023
Conn., November 13, 2023 - Intensity Therapeutics, Inc. (Nasdaq: INTS), a late-stage biotechnology company that applies
novel engineered chemistry to discover and develop proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors
and increase immune system recognition of cancers, today reported financial results for the third quarter ended September 30, 2023, and
provided a corporate update.
tissue sarcoma continues to plague cancer patients who have poor survival outcomes and insufficient therapeutic options. The positive
overall survival and disease control rate data from our Phase 1/2 clinical trial of INT230-6 positions our lead candidate as a potential
much needed reprieve, keeping the drug inside the tumor while sparing the body of toxicity. We expect to file an IND for a Phase 3 study
of INT230-6 in soft tissue sarcoma by the end of 2023 and look forward to progressing this study," said Lewis H. Bender, President
and Chief Executive Officer of Intensity.
Mr. Bender added: "To
continue the momentum built from our successful upsized IPO in July, we also look forward to reporting additional results from our Phase
2 INVINCIBLE study in presurgical breast cancer at a medical meeting and finalizing the study design and protocol for a Phase 2/3 program
in presurgical breast cancer before year end. I am pleased with our pace of progress to advance the clinical development of INT230-6 and
am strongly encouraged by data to date, which reinforces the potential of INT230-6 to shift the treatment paradigm of cancer."
Recent Company Highlights
Anticipated Near-Term Milestones
Third Quarter 2023 Financial Highlights
Research and Development (R&D) Expenses
were $1.4 million for the three months ended September 30, 2023, as compared to $1.2 million for the same period last year. The increase
is due to ongoing Phase 3 IT-03 in sarcoma and phase 2/3 IT-04 in presurgical breast cancer, which will continue to incur planning, multiple
regulatory filing, manufacturing, study initiation and trial preparation costs in 2023.
General and Administrative (G&A) Expenses
were $1.1 million for the three months ended September 30, 2023, as compared to $0.6 million for the same period in 2022. The increase
is primarily due to the costs of operating as a public company. 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
September 30, 2023, were $0 as compared to $15,123 for the three months ended September 30, 2022. The decrease is due to the convertible
notes and accrued interest being converted to common stock at the time of the IPO.
Net Operating Loss for the third quarter
ended September 30, 2023, was $2.3 million as compared to $1.8 million for the three months ended September 30, 2022.
Cash, Cash Equivalents and Marketable Securities
as of September 30, 2023, were approximately $15.6 million. The Company expects to have sufficient cash to fund current operations into
the second half of 2025.
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 is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer
molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the
tumor resulting in a favorable safety profile. In addition to local disease control, direct killing of the tumor by INT230-6 releases
a bolus of neoantigens specific to the patient's malignancy, leading to engagement of the immune system and systemic anti-tumor effects.
Importantly, these effects are mediated without immunosuppression that so often occurs with systemic chemotherapy.
About Intensity Therapeutics' Clinical Studies
INT230-6 has completed enrollment of over 200
patients in two phase 2 and phase 1 dose escalation clinical trials (NCT03058289 and NCT04781725) with various advanced solid tumors;
IT-01 in metastatic disease, and IT-02 the INVINCIBLE study, in presurgical breast cancer. The Company has a clinical collaboration agreement
with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6, Intensity's lead product candidate, and KEYTRUDA (pembrolizumab),
Merck's anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced pancreatic, colon, squamous cell and bile duct malignancies.
The Company also 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, in patients with advanced liver, breast and sarcoma cancers. Intensity managed the individual
combination arms separately with each respective partner via a joint development committee. The Company also executed agreements with
the Ottawa Hospital Research Institute (OHRI) and the Ontario Institute of Cancer Research (OICR) to study INT230-6 in the INVINCIBLE
study, a randomized controlled neoadjuvant phase 2 study in women with early-stage breast cancer. Near-term, Intensity expects to file
an Investigational New Drug (IND) application for a Phase 3 study of INT230-6 in soft tissue sarcoma as well as finalizing the study design
and protocol for a Phase 2/3 program in presurgical breast cancer.
Intensity Therapeutics
is a late-stage biotechnology company that applies novel engineered chemistry to turn "cold" tumors "hot" by enabling
its aqueous cytotoxic-containing drug product, INT230-6, to mix and saturate the dense, high-fat pressurized environment of the tumor.
As a result of the saturation, Intensity's clinical trials have demonstrated the ability if INT230-6 to kill tumors and elicit an
adaptive immune response within days of injection, representing a truly novel approach to cancer cell death that holds the potential to
shift the treatment paradigm and turn many deadly cancers into chronic diseases. For more information about the Company, including publications,
papers and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com.
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 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.
Investor Relations Contact:
Intensity Therapeutics, Inc.
Condensed Statement of Operations
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development costs | $ | 1,351,766 | $ | 1,160,737 | $ | 2,984,752 | $ | 4,241,203 | ||||||||
| General and administrative costs | 1,138,748 | 607,113 | 1,981,594 | 1,834,966 | ||||||||||||
| Total operating expenses | 2,490,514 | 1,767,850 | 4,966,346 | 6,076,169 | ||||||||||||
| Loss from operations | (2,490,514 | ) | (1,767,850 | ) | (4,966,346 | ) | (6,076,169 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 147,539 | 988 | 148,026 | 1,844 | ||||||||||||
| Interest expense | - | (15,123 | ) | (305,161 | ) | (44,877 | ) | |||||||||
| Loss on debt extinguishment | - | - | (2,261,581 | ) | - | |||||||||||
| Other | 13,230 | 7,118 | 18,304 | 47,646 | ||||||||||||
| Net loss | $ | (2,329,745 | ) | $ | (1,774,867 | ) | $ | (7,366,758 | ) | $ | (6,071,556 | ) | ||||
| Preferred stock deemed dividend | - | - | (1,323,535 | ) | - | |||||||||||
| Net loss attributable to common stockholders | $ | (2,329,745 | ) | $ | (1,774,867 | ) | $ | (8,690,293 | ) | $ | (6,071,556 | ) | ||||
| Loss per share, basic and diluted | $ | (0.17 | ) | $ | (0.52 | ) | $ | (1.26 | ) | $ | (1.78 | ) | ||||
| Weighted average number of shares of common stock, basic and diluted. | 13,660,627 | 3,410,103 | 6,899,984 | 3,410,103 |
Intensity Therapeutics, Inc.
Condensed Balance Sheets
| September 30, 2023 | December 31, 2022 | |||||||
| (unaudited) | (audited) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,693,825 | $ | 1,311,877 | ||||
| Marketable debt securities | 8,955,316 | - | ||||||
| Prepaid expenses | 971,239 | 62,924 | ||||||
| Other current assets | 14,366 | 75,535 | ||||||
| Total current assets | 16,634,746 | 1,450,336 | ||||||
| Right-of-use asset, net | 152,605 | 139,089 | ||||||
| Other assets | 28,438 | 167,738 | ||||||
| Total assets | $ | 16,815,789 | $ | 1,757,163 | ||||
| LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIENCY) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 358,404 | $ | 603,176 | ||||
| Accrued expenses | 355,006 | 1,723,400 | ||||||
| Current lease liability | 10,556 | 143,221 | ||||||
| Convertible note and accrued interest | - | 4,348,548 | ||||||
| Total current liabilities | 723,966 | 6,818,345 | ||||||
| Long-term lease liability | 144,891 | - | ||||||
| Related party deposit | 36,000 | 36,000 | ||||||
| Total liabilities | 904,857 | 6,854,345 | ||||||
| Series A redeemable convertible preferred stock, par value $.0001. Authorized, issued, and outstanding shares of none and 5,000,000 as of September 30, 2023 and December 31, 2022, respectively. | - | 10,000,000 | ||||||
| STOCKHOLDERS' EQUITY (DEFICIENCY) | ||||||||
| Authorized preferred stock is 15,000,000 shares as of September 30, 2023. None issued or outstanding as of September 30, 2023. | ||||||||
| Series B convertible preferred stock, par value $.0001. Authorized, issued, and outstanding shares of none and 1,449,113 as of September 30, 2023 and December 31, 2022, respectively. | - | 145 | ||||||
| Series C convertible preferred stock, par value $.0001. Authorized, issued, and outstanding shares of none and 1,800,606 as of September 30, 2023 and December 31, 2022, respectively. | - | 180 | ||||||
| Common stock, par value $.0001. Authorized shares of 135,000,000 and 50,000,000 as of September 30, 2023 and December 31, 2022, respectively. Issued and outstanding shares of 13,709,377 and 3,410,103 as of September 30, 2023 and December 31, 2022, respectively. | 1,371 | 341 | ||||||
| Additional paid-in capital | 63,252,862 | 23,555,160 | ||||||
| Accumulated deficit | (47,343,301 | ) | (38,653,008 | ) | ||||
| Total stockholders' equity (deficiency) | 15,910,932 | (15,097,182 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficiency) | $ | 16,815,789 | $ | 1,757,163 |