Intensity Therapeutics Reports Second Quarter Financial Results and Provides Corporate Update
Closed Upsized IPO Priced at Top-Of-Range, Full Exercise of the Over-Allotment Nets
Data 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
INVINCIBLE Study Data Presented at ASCO Showed INT230-6 Following One Intratumoral Dose Can Cause Immune Priming in Historically Quiescent Breast Cancers
"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
"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
per share, representing the top-of-the-range, raising net proceeds of$5.00 after full$20.5 million 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
General and Administrative (G&A) Expenses were
Interest Expense for the three months ended June 30, 2023 were
Net Operating Loss for the second quarter ended June 30, 2023 was
Cash and Cash Equivalents as of June 30, 2023, were approximately
Conference Call and Webcast Information
The Company will hold a conference call today at 8AM EDT.
To 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.
An 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.
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. For more information, please visit www.intensitytherapeutics.com and follow the Company on Twitter @IntensityInc.
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 Information
Investor Relations Contact:
Rx Communications Group
Michael Miller
(917)-633-6086
mmiller@rxir.com
US Media Contact:
KOGS Communication
Edna Kaplan
+1 781 639 1910
kaplan@kogspr.com
Financials
Intensity Therapeutics, Inc. | ||||||||||||||||
Condensed Statements of Operations | ||||||||||||||||
(Unaudited) | ||||||||||||||||
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) |
Intensity Therapeutics, Inc. | ||||||||
Condensed Balance Sheets | ||||||||
(Unaudited) | ||||||||
June 30, | December 31, | |||||||
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 | - | 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 | - | 145 | ||||||
Series C convertible preferred stocks, par value | - | 180 | ||||||
Common stock, par value | 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 |
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SOURCE Intensity Therapeutics, Inc.