Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX), today reported its
financial results for the fourth quarter and full year ended
December 31, 2018 and provided an update on the company’s
recent achievements.
“2018 marked another year of significant scientific, clinical,
and corporate milestones at Eidos. We successfully completed Phase
1 and Phase 2 studies of AG10 in healthy volunteers and
transthyretin amyloid cardiomyopathy patients, respectively, and
are now enrolling patients in a Phase 3 study,” said Neil Kumar
PhD, chief executive officer of Eidos. “We also made the transition
from a private company to a public company, completing a successful
initial public offering that provides the resources necessary to
execute upon our accelerated development plan.”
2018 Business Highlights
Corporate
- Completed Series B preferred stock financing raising $64
million.
- Completed initial public offering, with total gross proceeds of
$122.2 million including exercise of underwriters’ option to
purchase additional shares, from the sale of 7.2 million shares of
common stock.
- Augmented the expertise of the Company’s Board of Directors
with the appointment of four new Directors: Rajeev Shah, managing
director and portfolio manager at RA Capital; Eric Aguiar, MD,
partner at Aisling Capital; Ali Satvat, Member of KKR Management
LLC; and William Lis, former chief executive officer and a director
of Portola Pharmaceuticals.
Clinical and Regulatory
- Presented Phase 2 data for AG10 in ATTR-CM at the AHA 2018
Scientific Sessions in a late-breaking featured science oral
presentation.
- Began patient enrollment in ATTRibute-CM, a Phase 3 study of
AG10 in ATTR-CM with registrational 12-month endpoint.
- Presented complete data from Phase 1 study of AG10 in healthy
volunteers at poster presentation at Heart Failure Society of
America 22nd Annual Scientific Meeting
- Published design and preclinical characterization of AG10 in
the Journal of Medicinal Chemistry.
- Received Orphan Drug Designation from the U.S. Food and Drug
Administration (FDA) for AG10 for the treatment of ATTR.
- Received positive opinion for Orphan Designation from the
European Medicines Agency (EMA) for the treatment of ATTR.
Fourth Quarter and Full-Year 2018 Financial and
Operating Results
Cash and cash equivalents totaled $157.1 million at December 31,
2018 compared with $5.5 million at December 31, 2017.
Eidos reported a net loss attributable to common stockholders of
approximately $39.8 million or $1.86 per common
share, for the full year 2018, as compared to a net loss
attributable to common stockholders of $11.9 million or $3.32
per common share, for the prior year. The Company reported a
net loss attributable to common stockholders of $9.9
million or $0.27 per common share, for the fourth quarter of
2018, as compared to a net loss attributable to common stockholders
of $5.1 million or $1.32 per common share for the fourth
quarter of 2017. 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 full year 2018
were $28.5 million, as compared to $9.3 million for
the prior year. Research and development expenses for the fourth
quarter of 2018 were $8.3 million, as compared to $3.7
million for the same period in the prior year. Research and
development expenses for the fourth quarter included costs related
to contract manufacturing, the preparation for and conduct of AG10
clinical trials. General and administrative expenses for the full
year 2018 were $9.2 million, as compared to $2.7
million for the prior year. General and administrative
expenses for the fourth quarter of 2018 were $2.4 million, as
compared to $1.4 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 Annual Report on Form 10-K for the
year ended December 31, 2018, 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 |
|
|
|
Year Ended |
|
|
December 31, |
|
|
|
December 31, |
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses*: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
$ |
|
8,323 |
|
|
$ |
|
3,703 |
|
|
$ |
|
28,539 |
|
|
$ |
|
9,286 |
|
General and
administrative |
|
|
2,382 |
|
|
|
|
1,408 |
|
|
|
|
9,240 |
|
|
|
|
2,730 |
|
Total
operating expenses |
|
|
10,705 |
|
|
|
|
5,111 |
|
|
|
|
37,779 |
|
|
|
|
12,016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(10,705 |
) |
|
|
|
(5,111 |
) |
|
|
|
(37,779 |
) |
|
|
|
(12,016 |
) |
Other
income (expense), net |
|
|
851 |
|
|
|
|
- |
|
|
|
|
(2,946 |
) |
|
|
|
75 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net and comprehensive
loss |
|
|
(9,854 |
) |
|
|
|
(5,111 |
) |
|
|
|
(40,725 |
) |
|
|
|
(11,941 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
$ |
|
(9,854 |
) |
|
$ |
|
(5,111 |
) |
|
$ |
|
(39,812 |
) |
|
$ |
|
(11,941 |
) |
Net loss per share
attributable to common stockholders |
$ |
|
(0.27 |
) |
|
$ |
|
(1.32 |
) |
|
$ |
|
(1.86 |
) |
|
$ |
|
(3.32 |
) |
Weighted-average shares
used in computing net loss per share attributable to common
stockholders, basic and diluted |
|
|
36,128,132 |
|
|
|
|
3,869,328 |
|
|
|
|
21,366,995 |
|
|
|
|
3,596,673 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes
stock-based compensation as follows |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
|
456 |
|
|
$ |
|
419 |
|
|
$ |
|
1,325 |
|
|
$ |
|
519 |
|
General
and administrative |
|
|
372 |
|
|
|
|
627 |
|
|
|
|
1,201 |
|
|
|
|
629 |
|
Total stock-based compensation expense |
$ |
|
828 |
|
|
$ |
|
1,046 |
|
|
$ |
|
2,526 |
|
|
$ |
|
1,148 |
|
EIDOS THERAPEUTICS,
INC.Condensed Balance
Sheets(Unaudited)(In
thousands)
|
December
31, |
|
|
December
31, |
|
|
|
|
|
|
|
|
|
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash |
$ |
|
157,147 |
|
|
$ |
|
5,497 |
|
Related party receivable |
|
|
34 |
|
|
|
|
67 |
|
Prepaid expenses and other current assets |
|
|
1,789 |
|
|
|
|
484 |
|
Total current assets |
|
|
158,970 |
|
|
|
|
6,048 |
|
Property and equipment, net |
|
|
209 |
|
|
|
|
114 |
|
Other assets |
|
|
933 |
|
|
|
|
181 |
|
Total assets |
$ |
|
160,112 |
|
|
$ |
|
6,343 |
|
Liabilities, Redeemable Convertible Preferred Stock and
Stockholders’ Equity
(Deficit) |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
$ |
|
1,956 |
|
|
$ |
|
566 |
|
Related party payable |
|
|
256 |
|
|
|
|
372 |
|
Accrued expenses and other current liabilities |
|
|
2,577 |
|
|
|
|
1,300 |
|
Total current liabilities |
|
|
4,789 |
|
|
|
|
2,238 |
|
Other liabilities |
|
|
316 |
|
|
|
|
273 |
|
Total liabilities |
|
|
5,105 |
|
|
|
|
2,511 |
|
|
|
|
|
|
|
|
|
|
|
Redeemable convertible
preferred stock |
|
|
- |
|
|
|
|
17,028 |
|
Stockholders’ equity (deficit): |
|
|
|
|
|
|
|
|
|
Preferred stock |
|
|
- |
|
|
|
|
- |
|
Common stock |
|
|
37 |
|
|
|
|
4 |
|
Additional paid-in capital |
|
|
220,240 |
|
|
|
|
1,332 |
|
Accumulated deficit |
|
|
(65,270 |
) |
|
|
|
(14,532 |
) |
Total stockholders’ equity (deficit) |
|
|
155,007 |
|
|
|
|
(13,196 |
) |
Total liabilities, redeemable convertible preferred stock and
stockholders’ equity (deficit) |
$ |
|
160,112 |
|
|
$ |
|
6,343 |
|
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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