Synthorx Reports Second Quarter Financial Results
August 01 2019 - 4:05PM
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 ResultsFor 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.
General and administrative (G&A) expenses for the second
quarter ended June 30, 2019 were $3.0 million, compared to $0.6
million for the same period in 2018. For the six months ended June
30, 2019, G&A expenses were $5.4 million, compared to $1.0
million for the same period in 2018. The increase in G&A
expenses was primarily attributable to increased personnel and
related costs as the company expanded its G&A team to support
operations, including additional non-cash stock-based compensation
cost of $0.6 million and $0.8 million for the three and six months
ended June 30, 2019, as compared to the same periods in 2018.
Furthermore, the company incurred additional costs in 2019 that
were not incurred during the same period in 2018 as Synthorx now
operates as a public company, including additional insurance, legal
and accounting fees.
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.
About SynthorxSynthorx, Inc. is a
clinical-stage biotechnology company focused on prolonging and
improving the lives of people with cancer and autoimmune disorders.
Synthorx’ proprietary, first-of-its-kind Expanded Genetic Alphabet
platform technology expands the genetic code by adding a new DNA
base pair and is designed to create optimized biologics, referred
to as Synthorins. A Synthorin is a protein optimized through
incorporation of novel amino acids encoded by the new DNA base pair
that enables site-specific modifications, which enhance the
pharmacological properties of these therapeutics. The company’s
lead product candidate, THOR-707, a variant of interleukin-2
(IL-2), is in development in multiple tumor types as a single agent
and in combination with an immune checkpoint inhibitor. The company
was founded based on important discoveries at The Scripps Research
Institute. Synthorx is headquartered in La Jolla, Calif. For more
information, visit www.synthorx.com.
Forward-Looking StatementsStatements 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
the United States and foreign countries; Synthorx’s reliance on key
third parties, including contract manufacturers and contract
research organizations; Synthorx’s ability to obtain and maintain
intellectual property protection for its product candidates; the
loss of key scientific or management personnel; competition in the
industry in which Synthorx operates; and market conditions. For a
more detailed discussion of these and other factors, please refer
to Synthorx’s filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
All forward-looking statements are qualified in their entirety by
this cautionary statement and Synthorx undertakes no obligation to
revise or update this press release to reflect events or
circumstances after the date hereof, except as required by law.
Investor Relations Contacts: Enoch Kariuki,
Pharm.D.Synthorx, Inc.ekariuki@synthorx.com 858-750-4750
Christina TartagliaStern IR,
Inc.christina.tartaglia@sternir.com 212-362-1200
Media Relations Contact:Lauren
FishCanale
Communicationslauren@canalecomm.com 619-849-5386
SYNTHORX, INC. |
|
STATEMENTS OF OPERATIONS |
|
(in thousands, except share and per share
data) |
|
(unaudited) |
|
|
|
|
|
Three Months Ended
June 30, |
|
|
Six Months Ended
June 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
$ |
(12,370 |
) |
|
$ |
(4,003 |
) |
|
$ |
(23,221 |
) |
|
$ |
(6,193 |
) |
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SYNTHORX, INC. |
|
BALANCE SHEETS |
|
(in thousands) |
|
(unaudited) |
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2019 |
|
|
2018 |
|
Assets |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
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 |
|
Other assets |
|
|
30 |
|
|
|
80 |
|
Total assets |
|
$ |
173,393 |
|
|
$ |
191,506 |
|
Liabilities and
Stockholders’
Equity |
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
884 |
|
|
$ |
2,228 |
|
Accrued liabilities |
|
|
6,122 |
|
|
|
4,814 |
|
Lease liability, current |
|
|
403 |
|
|
|
— |
|
Total current liabilities |
|
|
7,409 |
|
|
|
7,042 |
|
Lease liability, noncurrent |
|
|
2,818 |
|
|
|
— |
|
Deferred rent |
|
|
- |
|
|
|
104 |
|
Total liabilities |
|
|
10,227 |
|
|
|
7,146 |
|
Stockholders’ equity |
|
|
163,166 |
|
|
|
184,360 |
|
Total liabilities and stockholders’ equity |
|
$ |
173,393 |
|
|
$ |
191,506 |
|
|
|
|
|
|
|
|
|
|
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