Synthorx Reports Second Quarter Financial Results
“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
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,
Synthorxpresented 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.
For the second quarter ended
Research and development (R&D) expenses for the second quarter ended
General and administrative (G&A) expenses for the second quarter ended
Statements in this press release that are not strictly historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to: plans underlying THOR-707 clinical trials and development; preclinical data or plans underlying any of our other development programs; references to the development of our product candidates; the potential safety and efficacy of THOR-707 and our other product candidates; and the potential advantages of these drug programs. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Synthorx’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as a development stage company; Synthorx’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in Synthorx’s plans to develop and commercialize its product candidates; the potential for clinical trials of THOR-707 or any future clinical trials of other product candidates to differ from preliminary or expected results; Synthorx’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in
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|STATEMENTS OF OPERATIONS|
|(in thousands, except share and per share data)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||$||10,425||$||3,387||$||19,989||$||5,152|
|General and administrative||3,040||602||5,395||1,027|
|Total operating expenses||13,465||3,989||25,384||6,179|
|Loss from operations||(13,465||)||(3,989||)||(25,384||)||(6,179||)|
|Other income (expense):|
|Change in fair value of preferred stock purchase right liability||—||(14||)||—||(14||)|
|Interest income, net||1,095||—||2,163||—|
|Net loss per common share, basic and diluted||$||(0.39||)||$||(4.21||)||$||(0.74||)||$||(6.54||)|
|Weighted average common shares outstanding, basic and diluted||31,561,445||951,066||31,496,114||946,854|
|June 30,||December 31,|
|Cash, cash equivalents and investments||$||165,178||$||188,356|
|Prepaid expenses and other current assets||3,554||1,688|
|Total current assets||168,732||190,044|
|Operating lease right-of-use asset||3,003||—|
|Property and equipment, net||1,628||1,382|
|Liabilities and Stockholders’ Equity|
|Lease liability, current||403||—|
|Total current liabilities||7,409||7,042|
|Lease liability, noncurrent||2,818||—|
|Total liabilities and stockholders’ equity||$||173,393||$||191,506|
Source: Synthorx, Inc.