Full Press Release Details
Therapeutics Reports Second Quarter Financial Results and Provides Corporate Update
Upsized IPO Priced at Top-Of-Range, Full Exercise of the Over-Allotment Nets $20.4 Million in Proceeds
Presented at ASCO Showed that Lead Asset INT230-6 Prolongs Survival Alone or in Combination With Ipilimumab in Adult Patients with Relapsed,
Refractory, Metastatic Sarcomas Compared To Synthetic Controls
Study Data Presented at ASCO Showed INT230-6 Following One Intratumoral Dose Can Cause Immune Priming in Historically Quiescent Breast
Conn., August 14, 2023 - 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
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.
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.
2023 Clinical Milestones
Quarter 2023 Financial Highlights
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.
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.
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.
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.
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.
Call and Webcast Information
Company will hold a conference call today at 8AM EDT.
participate in the conference call, please dial 1-877-317-6789 (domestic) or 1-412-317-6789 (international). To access a live webcast
of the call, please visit: https://ir.intensitytherapeutics.com/news-events/events-presentations.
archived replay of the webcast will be available for one year on the Intensity Therapeutics website at: https://ir.intensitytherapeutics.com/news-events/events-presentations.
Intensity Therapeutics
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. For more information, please visit www.intensitytherapeutics.com and follow the Company on Twitter
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.
Communications Group
Intensity Therapeutics,
Condensed Statements of Operations
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development costs | $ | 859,212 | $ | 1,385,966 | $ | 1,632,986 | $ | 3,080,466 | ||||||||
| General and administrative costs | 362,490 | 543,830 | 842,846 | 1,227,853 | ||||||||||||
| Total operating expenses | 1,221,702 | 1,929,796 | 2,475,832 | 4,308,319 | ||||||||||||
| Loss from operations | (1,221,702 | ) | (1,929,796 | ) | (2,475,832 | ) | (4,308,319 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 171 | 213 | 487 | 856 | ||||||||||||
| Interest expense | (221,779 | ) | (14,959 | ) | (305,161 | ) | (29,754 | ) | ||||||||
| Loss on debt extinguishment | (2,261,581 | ) | - | (2,261,581 | ) | - | ||||||||||
| Other | 4,349 | 16,900 | 5,074 | 40,528 | ||||||||||||
| Net loss | $ | (3,700,542 | ) | $ | (1,927,642 | ) | $ | (5,037,013 | ) | $ | (4,296,689 | ) | ||||
| Preferred stock deemed dividend | (1,323,535 | ) | - | (1,323,535 | ) | - | ||||||||||
| Net loss attributable to common stockholders | $ | (5,024,077 | ) | $ | (1,927,642 | ) | $ | (6,360,548 | ) | $ | (4,296,689 | ) | ||||
| Loss per share, basic and diluted | $ | (1.43 | ) | $ | (0.57 | ) | $ | (1.84 | ) | $ | (1.26 | ) | ||||
| Weighted average number of shares of common stock, basic and diluted. | 3,516,579 | 3,410,103 | 3,463,635 | 3,410,103 | ) |
The accompanying notes are an integral
part of these financial statements.
Intensity Therapeutics, Inc.
Condensed Balance Sheets
| June 30, 2023 | December 31, 2022 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 135,765 | $ | 1,311,877 | ||||
| Stock subscriptions receivable | 17,765,000 | - | ||||||
| Other current assets | 159,460 | 138,459 | ||||||
| Total current assets | 18,060,225 | 1,450,336 | ||||||
| Right-of-use asset, net | - | 139,089 | ||||||
| Other assets | 167,738 | 167,738 | ||||||
| Total assets | $ | 18,227,963 | $ | 1,757,163 | ||||
| LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIENCY) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,581,812 | $ | 603,176 | ||||
| Accrued expenses | 1,476,633 | 1,723,400 | ||||||
| Current lease liability | - | 143,221 | ||||||
| Convertible note and accrued interest | - | 4,348,548 | ||||||
| Total current liabilities | 3,058,445 | 6,818,345 | ||||||
| Related party deposit | 36,000 | 36,000 | ||||||
| Total liabilities | 3,094,445 | 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 June 30, 2023 and December 31, 2022, respectively. | - | 10,000,000 | ||||||
| STOCKHOLDERS' EQUITY (DEFICIENCY) | ||||||||
| Authorized preferred stock is 15,000,000 shares as of June 30, 2023. None issued or outstanding as of June 30, 2023. | ||||||||
| Series B convertible preferred stocks, par value $.0001. Authorized, issued, and outstanding shares of none and 1,449,113 as of June 30, 2023 and December 31, 2022, respectively. | - | 145 | ||||||
| Series C convertible preferred stocks, par value $.0001. Authorized, issued, and outstanding shares of none and 1,800,606 as of June 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 June 30, 2023 and December 31, 2022, respectively. Issued and outstanding shares of 13,099,377 and 3,410,103 as of June 30, 2023 and December 31, 2022, respectively. | 1,310 | 341 | ||||||
| Additional paid in capital | 60,145,764 | 23,555,160 | ||||||
| Accumulated deficit | (45,013,556 | ) | (38,653,008 | ) | ||||
| Total stockholders' equity (deficiency) | 15,133,518 | (15,097,182 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficiency) | $ | 18,227,963 | $ | 1,757,163 |
The accompanying notes are an integral part
of these financial statements.