On November 15, 2021 Theseus Pharmaceuticals, Inc. (NASDAQ: THRX), a biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development and commercialization of transformative targeted therapies, reported financial results for the third quarter ended September 30, 2021 (Press release, Theseus Pharmaceuticals, NOV 15, 2021, View Source [SID1234595624]).

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"At Theseus, we are leveraging our deep expertise in the development of targeted therapies to address the problem of drug resistance mutations in cancer," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus Pharmaceuticals. "The third quarter marked two significant milestones for Theseus: our entrance into the public markets and the start of our transition into a clinical-stage company. The recent IND clearance for our lead candidate, THE-630, a pan-variant KIT inhibitor with the potential to address unmet need in patients with previously treated gastrointestinal stromal tumors (GIST), and the completion of our successful IPO position Theseus well to advance both the Phase 1/2 clinical trial of THE-630 and our pipeline of novel pan-variant inhibitors specifically designed to overcome the full range of drug resistance mutations."

Third Quarter Highlights and Upcoming Milestones:

Received FDA clearance of an investigational new drug (IND) application to evaluate THE-630 in patients with GIST. Theseus plans to initiate a Phase 1/2 dose escalation and expansion clinical trial of THE-630, its lead development program, in patients with previously treated advanced GIST between late fourth quarter 2021 and mid-first quarter 2022. THE-630 is a pan-variant inhibitor of the receptor tyrosine kinase KIT designed for patients with advanced GIST whose cancer has developed resistance to earlier lines of therapy.
Completed $178.8 million upsized initial public offering. In October 2021, Theseus sold 11,172,190 shares of common stock at a price to the pubic of $16.00 per share. The gross proceeds from the offering were approximately $178.8 million, before deducting underwriting discounts and commissions and other estimated offering expenses.
Leadership strengthened through appointments to senior scientific team. Theseus recently appointed Nachu Narasimhan, Ph.D., as Senior Vice President, Drug Metabolism and Preclinical Safety, and Len Rozamus as Senior Vice President, Technical Operations. Together, their deep experience in targeted oncology research and development will help to further advance Theseus’ pipeline.
Dr. Narasimhan brings over 30 years of experience in drug metabolism and bioanalytical disciplines and over 10 years’ experience in preclinical safety and clinical pharmacology. Dr. Narasimhan was most recently Vice President of Drug Metabolism and Clinical Pharmacology at Verastem Oncology. Previously, he contributed to the development and approval of several drugs while working at Merck, ARIAD Pharmaceuticals, and Bristol-Myers-Squibb.
Mr. Rozamus brings over 30 years of experience in pharmaceutical discovery and development, from pre-clinical programs through commercial products. Most recently, Mr. Rozamus served as Founder and President of Rozamus and Associates, Inc. Previously, his work while Senior Director of Manufacturing Operations at ARIAD Pharmaceuticals contributed to the approval of three oncology drugs.
Advanced fourth-generation epidermal growth factor receptor (EGFR) program towards development candidate nomination in the first half of 2022, and thereafter initiate IND-enabling studies. For its second development program, Theseus expects to nominate an EGFR candidate designed to inhibit the full range of single-, double-, and triple-mutant EGFR variants found in the tumors of patients with EGFR-mutant non-small cell lung cancer (NSCLC) that have developed resistance to osimertinib, including the C797S mutation.
One or more additional kinase targets expected to be nominated by the end of 2022.
Third Quarter Financial Results:

As of September 30, 2021, Theseus had cash and cash equivalents of $90.4 million, which does not include net proceeds from its IPO, which was completed in October 2021.
Theseus expects its cash and cash equivalents, including proceeds from the IPO, to fund operations and capital expenditures into the second half of 2024.
Research & Development expenses for the third quarter of 2021 were $5.0 million.
General & Administrative expenses for the third quarter of 2021 were $2.4 million.
Net Loss for the third quarter 2021 was $7.4 million, or $5.16 per share.