Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX), today
reported its financial results for the first quarter ended
March 31, 2019 and provided an update on the company’s recent
achievements.
“The initiation of our Phase 3 ATTRibute-CM
study in the first quarter of 2019 marks another key milestone in
our focused effort to make AG10 available for the significant unmet
need in transthyretin (TTR) amyloidosis (ATTR),” said Neil Kumar
PhD, chief executive officer of Eidos. “In our prior clinical
studies, AG10 demonstrated near-complete stabilization of TTR and
significantly increased serum TTR, a biomarker associated with
survival in ATTR-CM patients. Based on these data, we believe AG10
may demonstrate a meaningful benefit in this patient
population.”
Recent Achievements and Upcoming
Milestones
- Initiated Phase 3 study of AG10 in ATTR-CM (ATTRibute-CM)
- Published Phase 2 data of AG10 in ATTR-CM in the Journal of the
American College of Cardiology (JACC)
- Presented sub-group analysis of Phase 2 data in ATTR-CM at
American College of Cardiology (ACC) Scientific Sessions
- Plan to initiate Phase 3 study of AG10 in ATTR-PN
(ATTRibute-PN) in the second half of 2019
- Plan to present data from the open label extension of the Phase
2 study of AG10 in ATTR-CM in the fourth quarter of 2019
First Quarter Financial and Operating
Results
Cash and cash equivalents totaled $147.1 million
at March 31, 2019 compared with $157.1 million at December 31,
2018.
Eidos reported a net loss attributable to common
stockholders of $11.7 million or $0.32 per common share,
for the first quarter of 2019, as compared to a net loss
attributable to common stockholders of $8.0 million or $1.81
per common share for the first quarter of 2018. The increase
in net loss attributable to common stockholders was driven
primarily by research and development expenses related to AG10
clinical trials and other pre-clinical studies, and general and
administrative expenses for operations.
Research and development expenses for the first
quarter of 2019 were $8.5 million, as compared to $5.7
million for the same period in the prior year. Research and
development expenses for the first quarter included costs related
to contract manufacturing, the preparation for and conduct of AG10
clinical trials.
General and administrative expenses for the
first quarter of 2019 were $4.0 million, as compared
to $2.3 million for the same period in the prior year.
The increase in general and administrative expense in these periods
was due primarily to an increase in professional service fees,
salaries and employee-related expense primarily due to an increase
in headcount to support the growth of our operations, and other
administrative expenses.
About AG10
AG10 is an investigational, orally-administered
small molecule designed to potently stabilize tetrameric
transthyretin, or TTR, thereby halting at its outset the series of
molecular events that give rise to amyloidosis, or ATTR. In a Phase
2 clinical trial in subjects with symptomatic ATTR-CM, AG10 was
generally well tolerated, demonstrated >90% average TTR
stabilization at day 28, and increased serum TTR concentrations, a
prognostic indicator of survival in a retrospective study of
ATTR-CM patients, in a dose-dependent manner. AG10 is currently
being studied in an open-label extension of a Phase 2 clinical
trial in patients with ATTR-CM, and patient enrollment has begun
for a Phase 3 clinical trial of AG10 in patients with ATTR-CM
(ATTRibute-CM).
AG10 was designed to mimic a naturally-occurring
variant of the TTR gene (T119M) that is considered a rescue
mutation because co-inheritance has been shown to prevent ATTR in
individuals also inheriting a pathogenic, or disease-causing,
mutation in the TTR gene. To our knowledge, AG10 is the only TTR
stabilizer in development that has been observed to mimic the
stabilizing structure of this rescue mutation.
About transthyretin amyloidosis
(ATTR)
ATTR represents a significant unmet medical need
with a large patient population and an inadequate current standard
of care. ATTR is caused by the destabilization of TTR due to
inherited mutations or aging and is commonly divided into three
distinct categories: wild-type ATTR cardiomyopathy (ATTRwt-CM),
mutant ATTR cardiomyopathy (ATTRm-CM), and ATTR polyneuropathy
(ATTR-PN). The worldwide prevalence of each disease is
approximately 400,000 patients, 40,000 patients and 10,000
patients, respectively.
All three forms of ATTR are progressive and
fatal. For patients with ATTRwt-CM and ATTRm-CM, symptoms usually
manifest later in life (age 50+), with median survival of three to
five years from diagnosis. ATTR-PN either presents in a patient's
early 30s or later (age 50+), and results in a median life
expectancy of five to ten years from diagnosis. Progression of all
forms of ATTR causes significant morbidity, impacts productivity
and quality of life, and creates a significant economic burden due
to the costs associated with progressively greater patient needs
for supportive care.
About Eidos Therapeutics
Eidos Therapeutics is a clinical stage
biopharmaceutical company focused on addressing the large and
growing unmet need in diseases caused by transthyretin (TTR)
amyloidosis (ATTR). Eidos is developing AG10, a potentially
disease-modifying therapy for the treatment of ATTR. For more
information, please visit www.eidostx.com.
Forward-Looking Statements
This release includes forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act. All statements other
than statements of historical facts, including the statements about
the potential therapeutic and clinical benefits of AG10, the
potential to accelerate the development and registration of AG10,
the design of the ATTRibute-CM trial, our ability to enroll
patients in and conduct the ATTRibute-CM trial in accordance with
our plans, future clinical and regulatory milestones of AG10, the
timing of these events, the indications we intend to pursue and our
possible clinical or other business strategies, and our ability to
fund our clinical development plans, are forward-looking
statements. Forward-looking statements can be identified by terms
such as “believes,” “expects,” “plans,” “potential,” “would” or
similar expressions and the negative of those terms. These
forward-looking statements are based on our management’s current
beliefs and assumptions about future events and on information
currently available to management. Forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause our actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. These risks include, but are not
limited to, risks and uncertainties related to: our limited
operating history and historical losses, our liquidity to fund the
development of AG10 through current and future milestones, our
ability to raise additional funding to complete the development of
AG10, our dependence on the success of AG10, our ability to enroll
patients in the ATTRibute-CM trial, results from our clinical
trials and pre-clinical studies and those of third
parties working in the same area as our product candidate, our
ability to advance AG10 in clinical development in accordance with
our plans, and our dependence on third parties in connection with
our manufacturing, clinical trials
and pre-clinical studies. Additional risks and
uncertainties that could affect our future results are included in
the section titled “Risk Factors” and “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” in our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2019,
to be filed with the Securities and Exchange Commission
concurrently herewith. Additional information on potential risks
will be made available in other filings that we make from time to
time with the SEC. In addition, any forward-looking statements
contained in this press release are based on assumptions that we
believe to be reasonable as of this date. Except as required by
law, we assume no obligation to update these forward-looking
statements, or to update the reasons if actual results differ
materially from those anticipated in the forward-looking
statements.
EIDOS THERAPEUTICS,
INC.Condensed Statements of
Operations(Unaudited)(In
thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
|
|
2019 |
|
|
|
2018 |
|
Operating
expenses*: |
|
|
|
|
|
|
|
Research and development |
$ |
8,549 |
|
|
$ |
5,652 |
|
General and
administrative |
|
4,035 |
|
|
|
2,345 |
|
Total operating expenses |
|
12,584 |
|
|
|
7,997 |
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(12,584 |
) |
|
|
(7,997 |
) |
Other income (expense), net |
|
851 |
|
|
|
(879 |
) |
|
|
|
|
|
|
|
|
Net and comprehensive
loss |
|
(11,733 |
) |
|
|
(8,876 |
) |
|
|
|
|
|
|
|
|
Deemed dividend related to
redemption feature embedded in Convertible Promissory Notes payable
to stockholders |
|
- |
|
|
|
(6,523 |
) |
Gain on extinguishment of
Convertible Promissory Notes payable to stockholders |
|
- |
|
|
|
7,436 |
|
|
|
|
|
|
|
|
|
Net loss attributable to
common stockholders |
$ |
(11,733 |
) |
|
$ |
(7,963 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.32 |
) |
|
$ |
(1.81 |
) |
Weighted-average shares used
in computing net loss per share attributable to common
stockholders, basic and diluted |
|
36,175,523 |
|
|
|
4,392,435 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes stock-based
compensation as follows |
|
|
|
|
|
|
|
Research and development |
$ |
452 |
|
|
$ |
178 |
|
General and administrative |
|
512 |
|
|
|
210 |
|
Total stock-based compensation expense |
$ |
964 |
|
|
$ |
388 |
|
|
|
|
|
|
|
|
|
EIDOS THERAPEUTICS,
INC.Condensed Balance
Sheets(Unaudited)(In
thousands)
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
2019 |
|
|
2018 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
147,064 |
|
|
$ |
157,147 |
|
Related party receivable |
|
72 |
|
|
|
34 |
|
Prepaid expenses and other current assets |
|
2,160 |
|
|
|
1,789 |
|
Total current assets |
|
149,296 |
|
|
|
158,970 |
|
Property and equipment,
net |
|
196 |
|
|
|
209 |
|
Operating lease, right of use
asset |
|
1,053 |
|
|
|
- |
|
Other assets |
|
2,652 |
|
|
|
933 |
|
Total assets |
$ |
153,197 |
|
|
$ |
160,112 |
|
Liabilities,
Redeemable Convertible Preferred Stock
and Stockholders’
Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
3,212 |
|
|
$ |
1,956 |
|
Related party payable |
|
407 |
|
|
|
256 |
|
Lease liabilities |
|
269 |
|
|
|
- |
|
Accrued expenses and other current liabilities |
|
3,953 |
|
|
|
2,577 |
|
Total current liabilities |
|
7,841 |
|
|
|
4,789 |
|
Other liabilities |
|
201 |
|
|
|
316 |
|
Lease liabilities,
non-current |
|
854 |
|
|
|
- |
|
Total liabilities |
|
8,896 |
|
|
|
5,105 |
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Preferred stock |
|
- |
|
|
|
- |
|
Common stock |
|
37 |
|
|
|
37 |
|
Additional paid-in capital |
|
221,267 |
|
|
|
220,240 |
|
Accumulated deficit |
|
(77,003 |
) |
|
|
(65,270 |
) |
Total stockholders’ equity |
|
144,301 |
|
|
|
155,007 |
|
Total liabilities, redeemable
convertible preferred stock and stockholders’ equity |
$ |
153,197 |
|
|
$ |
160,112 |
|
|
|
|
|
|
|
|
|
Media Contact:
Carolyn Hawley, Canale Communications, (619)
849-5382, carolyn@canalecomm.com
For Investors
Alex Gray, Burns McClellan, (212) 213-0006,
agray@burnsmc.com
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