Company Positioned for Upcoming 2019
Milestones After Successful IPO Raising $150.7 Million in Gross
Proceeds
Synthorx, Inc. (Nasdaq: THOR), a biotechnology company using a
unique Expanded Genetic Alphabet platform technology to discover
and develop optimized biologics for cancer and autoimmune (AI)
disorders, today reported financial results and provided a business
update for the fourth quarter and full year ended December 31,
2018.
“2018 was a transformative year for Synthorx. With the proceeds
from our initial public offering in December and Series C financing
earlier in the year, we are well-positioned to enter the clinic in
2019 with our lead IL-2 immuno-oncology (IO) Synthorin™, THOR-707,
and build our pipeline as we advance additional IO cytokines and
our IL-2 AI Synthorin product candidate into preclinical
development,” said Laura Shawver, president and chief executive
officer. “We are off to an excellent start to 2019 as we recently
completed a GMP fermentation of THOR-707 and expect to file our IND
in the second quarter of 2019.”
Fourth Quarter 2018 and Other Recent
Highlights
- Completed initial public offering and closed second tranche of
Series C. In December 2018, Synthorx completed an initial
public offering, selling 13,699,636 shares at a public offering
price of $11.00 per share, raising net proceeds of $137.5 million.
In addition, in November 2018, the Company completed the second
closing of its Series C financing, raising net proceeds of $37.1
million.
- Presented Preclinical Data at SITC. In November 2018,
Synthorx presented results of preclinical studies
demonstrating the safety and anti-tumor effects of THOR-707 for the
treatment of solid tumors at the Society for Immunotherapy of
Cancer (SITC) 33rd Annual Meeting. In in vivo studies, THOR-707 was
shown to induce molecular markers of T cell activation and the
proliferation of peripheral NK and CD8+ effector T cells without
signs of vascular leak syndrome.
- Began GLP-tox studies of THOR-707. In the fourth quarter,
the company completed scale up of THOR-707 through a third-party
manufacturer and began IND-enabling toxicology studies at a
contract laboratory
- Appointed Pratik Shah, Ph.D. and Andrew Powell, J.D. as
Directors. In October 2018, Synthorx appointed Dr. Shah,
Ph.D. to its board of directors and in December, Dr. Shah was
appointed as Chairman of the Board. Also, in December, Mr. Powell
was appointed to the Company’s board of directors.
Financial ResultsFor the fourth quarter ended
December 31, 2018, Synthorx reported a net loss of $28.2 million,
compared to a net loss of $2.2 million for the comparable
period in 2017. For the year ended December 31, 2018, the Company
reported a net loss of $56.6 million, compared to a net loss of
$5.9 million for 2017. Included in the net loss for the fourth
quarter and year ended December 31, 2018 were non-cash charges of
$19.7 million and $36.0 million, respectively, related to a
preferred stock purchase right that was exercised in November 2018.
There were no such charges in 2017.
Research and development expenses for the fourth quarter ended
December 31, 2018 were $7.0 million, compared to $1.5 million
for the same period in 2017. For the year ended December 31, 2018,
research and development expenses were $16.8 million, compared
to $3.9 million for 2017. The increases in the Company’s
research and development expenses for the 2018 periods, as compared
to the same periods in 2017, were primarily attributable to the
advancement of its THOR-707 program, including the scale-up of its
manufacturing capabilities and preclinical advancement of its
THOR-707 Synthorin. Synthorx also incurred additional
personnel-related costs in 2018 as compared to 2017 as operations
grew in support of program advances.
General and administrative expenses for the fourth quarter ended
December 31, 2018 were $1.8 million, compared to $0.7 million
for the same period in 2017. For the year ended December 31, 2018,
general and administrative expenses were $4.1 million, compared to
$1.9 million for the same period in 2017. The increases in general
and administrative expenses for the 2018 periods, as compared to
the same periods in 2017, were primarily attributable to an
increase in personnel-related costs and higher costs to operate as
a public company.
As of December 31, 2018, Synthorx reported cash and cash
equivalents of $188.4 million, compared to $3.7 million at December
31, 2017. The Company’s cash and cash equivalents balance at
December 31, 2018 included $137.5 million of proceeds, net of
offering costs, from the Company’s initial public offering in
December 2018, and $37.1 million of proceeds, net of offering
costs, from the Company’s Series C financing in November 2018. As
of December 31, 2018, the Company had 31,394,830 common shares
outstanding.
About SynthorxSynthorx, Inc. is a biotechnology
company focused on prolonging and improving the lives of people
with cancer and autoimmune disorders. Synthorx’s 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 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 in Dr. Floyd Romesberg’s lab at The Scripps
Research Institute. The Company 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: preclinical data or
plans underlying THOR-707 or any of our other development programs;
references to the manufacturing and development of, and potential
timing of regulatory submissions for, THOR-707 and our other
product candidates; the potential 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 any future clinical trials of
THOR-707 or 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
discussion of these and other factors, please refer to Synthorx’s
Annual Report on Form 10-K for the year ended December 31, 2018 as
well as Synthorx’s subsequent 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 par value
data) |
|
(unaudited) |
|
|
|
Three Months Ended |
|
|
Years Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
7,006 |
|
|
$ |
1,542 |
|
|
$ |
16,822 |
|
|
$ |
3,948 |
|
General
and administrative |
|
|
1,784 |
|
|
|
652 |
|
|
|
4,078 |
|
|
|
1,902 |
|
Total
operating expenses |
|
|
8,790 |
|
|
|
2,194 |
|
|
|
20,900 |
|
|
|
5,850 |
|
Loss from
operations |
|
|
(8,790 |
) |
|
|
(2,194 |
) |
|
|
(20,900 |
) |
|
|
(5,850 |
) |
Other (expense)
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
Income |
|
|
292 |
|
|
|
— |
|
|
|
292 |
|
|
|
— |
|
Change in
fair value of preferred stock purchase right liability |
|
|
(19,664 |
) |
|
|
— |
|
|
|
(36,001 |
) |
|
|
— |
|
Net loss |
|
$ |
(28,162 |
) |
|
$ |
(2,194 |
) |
|
$ |
(56,609 |
) |
|
$ |
(5,850 |
) |
Net loss per share,
basic and diluted |
|
$ |
(2.94 |
) |
|
$ |
(2.37 |
) |
|
$ |
(18.11 |
) |
|
$ |
(6.65 |
) |
Weighted average shares
of common stock outstanding, basic and diluted |
|
|
9,571,059 |
|
|
|
925,763 |
|
|
|
3,125,242 |
|
|
|
879,249 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SYNTHORX, INC. |
|
BALANCE SHEETS |
|
(in thousands) |
|
(unaudited) |
|
|
|
December 31, |
|
|
|
2018 |
|
|
2017 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
188,356 |
|
|
$ |
3,661 |
|
Prepaid
expenses and other current assets |
|
|
1,688 |
|
|
|
66 |
|
Total
current assets |
|
|
190,044 |
|
|
|
3,727 |
|
Property and equipment,
net |
|
|
1,382 |
|
|
|
692 |
|
Other assets |
|
|
80 |
|
|
|
50 |
|
Total
assets |
|
$ |
191,506 |
|
|
$ |
4,469 |
|
Liabilities,
Convertible Preferred Stock and
Stockholders’ Equity
(Deficit) |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
2,228 |
|
|
$ |
469 |
|
Accrued
liabilities |
|
|
4,814 |
|
|
|
412 |
|
Total
current liabilities |
|
|
7,042 |
|
|
|
881 |
|
Deferred rent |
|
|
104 |
|
|
|
13 |
|
Total
liabilities |
|
|
7,146 |
|
|
|
894 |
|
Convertible preferred
stock |
|
|
— |
|
|
|
16,103 |
|
Stockholders’ equity
(deficit) |
|
|
184,360 |
|
|
|
(12,528 |
) |
Total
liabilities, convertible preferred stock and stockholders’ equity
(deficit) |
|
$ |
191,506 |
|
|
$ |
4,469 |
|
|
|
|
|
|
|
|
|
|
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