Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX), today reported its
financial results for the fourth quarter and full year ended
December 31, 2019 and provided an update on the company’s
recent achievements.
“2019 marked another year of significant
scientific, clinical, and corporate progress at Eidos. We presented
positive data from the ongoing phase 2 open label extension study
suggesting long-term tolerability of AG10 and stabilization of
transthyretin amyloid cardiomyopathy disease measures,” said Neil
Kumar PhD, chief executive officer of Eidos. “We believe the data
support the hypothesis that increasing stabilization may lead to
improved outcomes for ATTR patients.”
2019 Highlights
- Presented interim analysis of the ongoing Phase 2 open label
extension study of AG10 in patients with TTR amyloid cardiomyopathy
at the AHA 2019 Scientific Sessions in a Late-Breaking Featured
Science Oral Presentation. Rates of mortality and cardiovascular
hospitalization observed in exploratory analysis were lower than
rates observed in placebo-treated participants in the ATTR-ACT
study. Serum TTR levels, a prognostic indicator of survival, were
elevated and maintained in the normal range throughout the study
duration.
- Initiated and continued enrollment of 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.
- Published Phase 1 data of AG10 in healthy volunteers in
Clinical Pharmacology in Drug Development.
- Granted Alexion Pharmaceuticals, Inc. an exclusive license to
develop and commercialize AG10 in Japan for an upfront payment of
$25.0 million and an equity investment of $25.0 million.
- Appointed Uma Sinha, Chief Scientific Officer, to the Board of
Directors.
- Plan to initiate Phase 3 study of AG10 in ATTR-PN
(ATTRibute-PN) in the first half of 2020.
Fourth Quarter and Full-Year 2019
Financial and Operating Results
Cash and cash equivalents totaled $191.2 million
at December 31, 2019 compared with $157.1 million at December 31,
2018.
Eidos reported a net loss attributable to common
stockholders of approximately $37.8 million or $1.03 per
common share, for the full year 2019, as compared to a net
loss attributable to common stockholders of $39.8 million or
$1.86 per common share, for the prior year. The Company
reported a net loss attributable to common stockholders
of $19.0 million or $0.51 per common share, for the
fourth quarter of 2019, as compared to a net loss attributable to
common stockholders of $9.9 million or $0.27 per common
share, for the fourth 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 full
year 2019 were $46.9 million, as compared to $28.5
million for the prior year. Research and development expenses
for the fourth quarter of 2019 were $13.9 million, as compared
to $8.3 million for the same period in the prior year.
Research and development expenses for the fourth quarter included
costs related to contract manufacturing and the preparation for and
conduct of clinical trials of AG10.
General and administrative expenses for the full
year 2019 were $17.8 million, as compared to $9.2
million for the prior year. General and administrative
expenses for the fourth quarter of 2019 were $5.5 million, as
compared to $2.4 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 TTR amyloidosis, or ATTR. In a
randomized, placebo-controlled Phase 2 clinical trial in patients
with symptomatic ATTR-CM, AG10 was generally well tolerated,
demonstrated greater than 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. The open label extension of this Phase 2
clinical trial, or the Phase 2 OLE, identified no safety signals of
potential clinical concern associated with administration of AG10
15 months after study initiation. In an exploratory analysis, lower
rates of all-cause mortality (including death and cardiac
transplantation) and cardiovascular hospitalizations were observed
in study participants than in placebo-treated ATTR-CM patients in
the ATTR-ACT study. Cardiac biomarkers and echocardiographic
parameters were stable in the AG10 Phase 2 OLE.
AG10 is currently being studied in a Phase 3
clinical trial in patients with ATTR-CM (ATTRibute-CM), and we
expect to initiate a Phase 3 clinical trial of AG10 in patients
with ATTR-PN in the first half of 2020.
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)
There is significant medical need in ATTR given
the large patient population and limited 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 for untreated
patients. 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, our
ability to enroll patients in and conduct the ATTRibute-CM trial
and to initiate and conduct our planned Phase 3 clinical trial of
AG10 in ATTR-PN 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 our ongoing and planned
clinical trials, 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, 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 |
|
|
|
Year Ended |
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
License revenue |
$ |
- |
|
|
$ |
- |
|
|
$ |
26,691 |
|
|
$ |
- |
|
Operating
expenses*: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of license revenue |
|
- |
|
|
|
- |
|
|
|
2,500 |
|
|
|
- |
|
Research and development |
|
13,858 |
|
|
|
8,323 |
|
|
|
46,891 |
|
|
|
28,539 |
|
General and
administrative |
|
5,466 |
|
|
|
2,382 |
|
|
|
17,751 |
|
|
|
9,240 |
|
Total operating expenses |
|
19,324 |
|
|
|
10,705 |
|
|
|
67,142 |
|
|
|
37,779 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(19,324 |
) |
|
|
(10,705 |
) |
|
|
(40,451 |
) |
|
|
(37,779 |
) |
Interest expense |
|
(327 |
) |
|
|
- |
|
|
|
(327 |
) |
|
|
(1,011 |
) |
Other income (expense), net |
|
671 |
|
|
|
851 |
|
|
|
2,943 |
|
|
|
(1,935 |
) |
Net and comprehensive
loss |
|
(18,980 |
) |
|
|
(9,854 |
) |
|
|
(37,835 |
) |
|
|
(40,725 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
$ |
(18,980 |
) |
|
$ |
(9,854 |
) |
|
$ |
(37,835 |
) |
|
$ |
(39,812 |
) |
Net loss per share
attributable to common stockholders |
$ |
(0.51 |
) |
|
$ |
(0.27 |
) |
|
$ |
(1.03 |
) |
|
$ |
(1.86 |
) |
Weighted-average shares used
in computing net loss per share attributable to common
stockholders, basic and diluted |
|
37,277,751 |
|
|
|
36,128,132 |
|
|
|
36,624,692 |
|
|
|
21,366,995 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes stock-based
compensation as follows |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
683 |
|
|
$ |
456 |
|
|
$ |
2,313 |
|
|
$ |
1,325 |
|
General and administrative |
|
965 |
|
|
|
372 |
|
|
|
3,060 |
|
|
|
1,201 |
|
Total stock-based compensation expense |
$ |
1,648 |
|
|
$ |
828 |
|
|
$ |
5,373 |
|
|
$ |
2,526 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EIDOS THERAPEUTICS,
INC.Condensed Balance
Sheets(Unaudited)(In
thousands)
|
December 31, |
|
|
December 31, |
|
|
|
|
|
|
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash |
$ |
191,157 |
|
|
$ |
157,147 |
|
Related party receivable |
|
85 |
|
|
|
34 |
|
Prepaid expenses and other current assets |
|
4,678 |
|
|
|
1,789 |
|
Total current assets |
|
195,920 |
|
|
|
158,970 |
|
Property and equipment,
net |
|
1,259 |
|
|
|
209 |
|
Operating lease, right of use
asset |
|
4,010 |
|
|
|
- |
|
Other assets |
|
2,631 |
|
|
|
933 |
|
Total assets |
$ |
203,820 |
|
|
$ |
160,112 |
|
Liabilities and
Stockholders’
Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
3,151 |
|
|
$ |
1,956 |
|
Related party payable |
|
316 |
|
|
|
256 |
|
Lease liabilities |
|
554 |
|
|
|
|
|
Accrued expenses and other current liabilities |
|
6,409 |
|
|
|
2,577 |
|
Total current liabilities |
|
10,430 |
|
|
|
4,789 |
|
Debt, non-current |
|
16,112 |
|
|
|
- |
|
Lease liabilities,
non-current |
|
4,591 |
|
|
|
- |
|
Embedded Derivative |
|
1,165 |
|
|
|
- |
|
Other liabilities |
|
95 |
|
|
|
316 |
|
Total liabilities |
|
32,393 |
|
|
|
5,105 |
|
|
|
|
|
|
|
|
|
Stockholders’ equity
(deficit): |
|
|
|
|
|
|
|
Common stock |
|
38 |
|
|
|
37 |
|
Additional paid-in capital |
|
274,494 |
|
|
|
220,240 |
|
Accumulated deficit |
|
(103,105 |
) |
|
|
(65,270 |
) |
Total stockholders’ equity |
|
171,427 |
|
|
|
155,007 |
|
Total liabilities and
stockholders’ equity |
$ |
203,820 |
|
|
$ |
160,112 |
|
|
|
|
|
|
|
|
|
Media Contact:
Carolyn Hawley, Canale Communications, (619)
849-5382, carolyn@canalecomm.com
For Investors
John Grimaldi, Burns McClellan, (212) 213-0006,
jgrimaldi@burnsmc.com
Eidos Therapeutics (NASDAQ:EIDX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Eidos Therapeutics (NASDAQ:EIDX)
Historical Stock Chart
From Apr 2023 to Apr 2024