SAN DIEGO, Aug. 01, 2019 (GLOBE NEWSWIRE) -- Synthorx, Inc. (NASDAQ:THOR), a clinical-stage biotechnology company developing optimized therapeutics for cancer and autoimmune disorders, today reported financial results and provided a business update for the second quarter ended June 30, 2019.
"At Synthorx, we continue to leverage our Expanded Genetic Alphabet platform to rapidly develop a range of cytokine candidates with optimized properties against oncology and autoimmune targets," said Laura Shawver, president and chief executive officer of Synthorx. "In recent months, we have made significant progress with the dosing of patients in Australia in the Phase 1/2 HAMMER trial of our lead candidate THOR-707, a ‘not-alpha' Synthorin of IL-2, and FDA's clearance of our investigational new drug application for THOR-707."
Second Quarter 2019 and Other Recent Highlights
- THOR-707 trial initiated: In June, the company began dosing patients in HAMMER, a global, Phase 1/2, first-in-human clinical trial of THOR-707 in Australia. This is the first Synthorin™ developed from the Expanded Genetic Alphabet platform to enter the clinic. The Phase 1/2 single agent and combination arms of the trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of THOR-707 in patients with advanced or metastatic solid tumors.
- U.S. IND cleared for THOR-707: In July, the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for THOR-707 in solid tumors, paving the way for enrollment in the U.S.
- Presented preclinical data at ASCO Annual Meeting: In June, Synthorx presented at the American Society of Clinical Oncology (ASCO) Annual Meeting its approach to utilizing its first-of-its-kind Expanded Genetic Alphabet platform technology to engineer IL-2 to improve its pharmacological profile. The preclinical data presented demonstrated the potential safety and anti-tumor effects of THOR-707.
Financial Results
For the second quarter ended June 30, 2019, Synthorx reported a net loss of $12.4 million, compared to a net loss of $4.0 million for the comparable period in 2018. For the six months ended June 30, 2019, the company reported a net loss of $23.2 million, compared to a net loss of $6.2 million for the comparable period in 2018.
Research and development (R&D) expenses for the second quarter ended June 30, 2019 were $10.4 million, compared to $3.4 million for the same period in 2018. For the six months ended June 30, 2019, R&D expenses were $20.0 million, compared to $5.2 million for the same period in 2018. The increase in the company's R&D expenses for the 2019 periods are primarily attributable to the advancement of its THOR-707 program and related activities, including costs to develop its clinical supply manufacturing capabilities and clinical trial costs as it initiates its Phase 1/2 clinical study. Further, the company incurred additional personnel and related costs as it has expanded its R&D team to support the development efforts for its programs.
As of June 30, 2019, Synthorx reported cash, cash equivalents and investment securities of $165.2 million, compared to $188.4 million at December 31, 2018.
Investor Relations Contacts:
Enoch Kariuki, Pharm.D.
Synthorx, Inc.
[email protected]
858-750-4750
Christina Tartaglia
Stern IR, Inc.
[email protected]
212-362-1200
Media Relations Contact:
Lauren Fish
Canale Communications
[email protected]
619-849-5386
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