MAIA Biotechnology, Inc.
We are a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer. THIO, our lead asset, is an investigational dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. THIO will enter Phase 2 human trials (THIO-101) in Australia and Europe in the first half of 2022. Patients with advanced Non-Small Cell Lung Cancer (NSCLC) will be treated first with THIO, followed a few days later by the immune checkpoint inhibitor Libtayo® (cemiplimab) manufactured and commercialized by Regeneron. Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. Cemiplimab has been approved in the United States and the rest of the world for multiple cancer indications, including NSCLC. In February 2021, we signed a clinical supply agreement with Regeneron to receive cemiplimab at no cost, which represents a significant cost savings for the study. In return, we have granted Regeneron exclusive development rights in combination with PD-1 inhibitors for NSCLC for the study period.
Based on the clinical data generated by our THIO-101 trial, in late 2024 we plan to seek an accelerated approval of THIO in the United States for the treatment of patients with advanced NSCLC, but even if granted, accelerated approval status does not guarantee an accelerated review or marketing approval by the FDA. In addition, in the first quarter of 2023, we plan to initiate a pivotal Phase 2 clinical trial in patients with advanced colorectal cancer, hepatocellular carcinoma, and small cell lung cancer, of THIO administered in sequence with Anti-PD-1 or Anti-PD-L1 by end of 2023.
**Note: MAIA Biotechnology has not generated any revenues from product sales. Its net loss is for the year ended Dec. 31, 2021.
(Note: MAIA Biotechnology, Inc. priced its IPO on July 27, 2022, by increasing the number of shares to 2 million, up from 1.67 million in the prospectus, and pricing the IPO at $5.00 – the bottom of its $5.00-to$8.00 range – to raise $10 million. MAIA Biotechnology set terms for its IPO in an S-1/A filing dated July 13, 2022: 1.67 million shares at $5.00 to $7.00 to raise $10.02 million. MAIA Biotechnology filed its S-1 on April 11, 2022; confidential IPO paperwork was filed on Oct. 15, 2021.)
|Address||444 West Lake Street, Suite 1700 Chicago, IL 60606|
|Phone Number||(312) 416-8592|
|View Prospectus:||MAIA Biotechnology, Inc.|
|Revenues||$0 mil (last 12 months)|
|Net Income||$-12.58 mil (last 12 months)|
|Exchange||NYSE - American|
|Price range||$5.00 - $5.00|
|Est. $ Volume||$10.0 mil|
|Manager / Joint Managers||ThinkEquity|
|Expected To Trade:||7/28/2022|
|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|