Intensity Therapeutics, Inc.
Intensity Therapeutics, Inc. is a clinical stage biotechnology company passionately committed to applying scientific leadership in the field of localized cancer reduction leading to anti-cancer immune activation. Our new approach involves the direct injection into tumors of a unique product created from our DfuseRx℠ discovery platform.
Our lead product candidate, INT230-6, consists of two proven anti-cancer cytotoxic agents, cisplatin and vinblastine sulfate, mixed with the amphiphilic molecule (SHAO) — all in one vial. Cisplatin was first approved in 1978 for testicular cancer. Per the product labeling, cisplatin’s approved indications include treatment of testicular, ovarian and bladder cancer. The drug is also used widely in several other cancers, including pancreatic and bile duct cancer. Vinblastine sulfate was first approved in 1965. Per the product labeling, vinblastine sulfate’s approved indications include treatment of generalized Hodgkin’s disease, lymphocytic lymphoma, advanced carcinoma of the testis, and Kaposi’s sarcoma. The drug is also used in breast and lung cancer. In 2017, we initiated a Phase 1/2 dose escalation study using INT230-6 in the United States under an investigational new drug application (“IND”) authorized by the FDA and in Canada following receipt of a no objection letter from Health Canada. The study, IT-01, is exploring the safety and efficacy of INT230-6 in patients with refractory or metastatic cancers. We completed the Phase 1 dose escalation portion of this study.
We are currently conducting the Phase 2 portion of the trial, which consists of several different expansion cohorts. Four of the cohorts combine our product candidate with Merck’s Keytruda® (pembrolizumab) and 3 arms combine our drug candidate with Bristol-Myers Squibb’s drug Yervoy® (ipilimumab). We are also evaluating INT230-6 in a Phase 2 study (the INVINCIBLE study) in Canada as a treatment before surgery in early-stage breast cancer.
Between the metastatic study IT-01 and the INVINCIBLE study, we have treated over 115 patients as of Sept. 30, 2021.
**Note: Revenue and net loss figures are for the 12 months that ended June 30, 2022.
(Note: Intensity Therapeutics cut the assumed price of its IPO to $4.50 – down from its previous price range of $4.00 to $6.00 – and kept the number of shares at 1.78 million (1,777,778 shares) – to raise $8.0 million, according to an S-1/A filing dated Jan. 27, 2023. Two weeks earlier: Intensity Therapeutics revived its IPO – postponed in early November 2022 – by cutting the deal’s size by 10 percent to 1.78 million shares – down from 2.22 million shares – and keeping the price range at $4.00 to $6.00 – to raise $8.9 million, according to an S-1/A filing dated Jan. 13, 2023. In that filing, The Benchmark Company is named as the sole book-runner. Roth Capital Partners dropped out as the lead left joint book-runner and exited the deal in January 2023. Background: Intensity Therapeutics, Inc. (INTS proposed) postponed its IPO on Wednesday, Nov. 9, 2022. The $10 million IPO – a carry-over from previous weeks – had been expected to price on Monday night, Nov. 7, and then was pushed back a night to Nov. 8, 2022 (Election Night – midterm congressional elections) – and the deal did not get done.)
(Background: Intensity Therapeutics revamped its IPO in an S-1/A filing dated Sept. 19, 2022, by deleting the warrants, increasing the number of shares, cutting the price range, and adding insiders’ indication of interest in buying up to $5 million of stock – or up to half of the $10 million IPO – under its revised terms. Intensity Therapeutics’ new IPO terms, as of Sept. 19, 2022, are: 2.22 million shares (2,222,223 shares), up from 2.14 million units (each unit had included one share of common stock and one warrant to buy one share of stock), at a price range of $4.00 to $5.00, down from the previous price range of $6.00 to $8.00. Estimated IPO proceeds are now about $10 million – down from $14.98 million previously. The IPO’s joint book-runners are Roth Capital Partners and The Benchmark Company, a switch from A.G.P and Brookline Capital Markets initially. This IPO has been in the works since its S-1 was filed on Oct. 28, 2021, following a confidential filing on Sept. 20, 2021.)
|Address||61 Wilton Road, 3rd Floor Westport, CT 06880|
|Phone Number||(203) 221-7381|
|View Prospectus:||Intensity Therapeutics, Inc.|
|Revenues||$0 mil (last 12 months)|
|Net Income||$-8.82 mil (last 12 months)|
|Price range||$4.50 - $4.50|
|Est. $ Volume||$8.0 mil|
|Manager / Joint Managers||The Benchmark Company|
|Expected To Trade:||2/6/2023|
|Quiet Period Expiration Date:||Available only to Subscribers|
|Lock-Up Period Expiration Date:||Available only to Subscribers|
|SCOOP Rating||Available only to Subscribers|
|Rating Change||Available only to Subscribers|