Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX), today
reported its financial results for the first quarter ended March
31, 2020 and provided an update on the company’s operations.
“We are living in unprecedented times as the impact of the
COVID-19 pandemic spreads globally. We know ATTR patients are at
great risk from COVID-19, and we are working with our
investigators, clinical trial site administrators and patient
advocacy leaders to put the health and welfare of our patients
first,” said Neil Kumar, PhD, chief executive officer of Eidos. “We
have made several operational changes to ensure their safety,
critically ensuring that our investigational medicine is supplied
without interruption, which in many cases has required direct
delivery to study participants at their homes. We continue to
believe that AG10 could be a best-in-class, convenient oral therapy
for ATTR patients and remain committed to developing the drug as
quickly and safely as possible.”
Update on Company Operations
Due to the impact of COVID-19, the Company has made several
operational changes to ensure patient safety, comply with global
health authorities’ guidance, and maintain the integrity of its
planned and ongoing clinical trials to evaluate the safety and
efficacy of AG10 as a therapy for ATTR patients. These changes
include:
- Arranging alternatives to clinic visits for trial participants
and study staff to minimize in-person interactions
- Facilitating home delivery of investigational medicine to
enrolled participants where possible
- Identifying and implementing solutions to track and reduce
missing data and protocol deviations
As COVID-19’s long-term impact on study enrollment remains
uncertain – the pandemic has unavoidably led to a slowdown in site
activation and participant enrollment – the Company cannot predict
with certainty the timing of the completion of enrollment in
ATTRibute-CM. We currently expect enrollment of ATTRibute-CM to be
completed in the first half of 2021 and plan to initiate our Phase
3 study of AG10 in ATTR-PN (ATTRibute-PN) in the second half of
2020.
The company has raised a total of $48.1 million since December
2019, including $24.1 million during the three months ended March
31, 2020, through “at-the-market” offerings under the 2019
Registration Statement on Form S-3. We believe the company is well
positioned with sufficient capital to fund through the receipt of
Part A data from the Phase 3 ATTR-CM trial.
First Quarter 2020 Financial and Operating
Results
Cash and cash equivalents totaled $196.5 million at March 31,
2020 compared with $191.2 million at December 31, 2019.
Eidos reported a net loss attributable to common stockholders of
approximately $22.8 million or $0.60 per common
share, for the first quarter of 2020, as compared to a net
loss attributable to common stockholders of $11.7 million or
$0.32 per common share, for the first quarter of 2019. 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 2020
were $17.6 million, as compared to $8.5 million for
the same period in the prior year. Research and development
expenses for the first quarter included costs related to contract
manufacturing and the preparation for and conduct of clinical
trials of AG10.
General and administrative expenses for the first quarter of
2020 were $5.3 million, as compared to $4.0
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 marketing costs, 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
(ATTRibute-PN) in the second 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, the impact of
the COVID-19 pandemic on our research and development activities
and other business operations, 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 capital
requirements and 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 Quarterly Report on Form 10-Q for the
quarter ended March 31, 2020, 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, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
Research and development |
$ |
|
17,575 |
|
|
$ |
|
8,549 |
|
|
General and
administrative |
|
|
5,311 |
|
|
|
|
4,035 |
|
|
Total operating expenses |
|
|
22,886 |
|
|
|
|
12,584 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(22,886 |
) |
|
|
|
(12,584 |
) |
|
Interest expense |
|
|
(518 |
) |
|
|
|
- |
|
|
Other income (expense), net |
|
|
580 |
|
|
|
|
851 |
|
|
Net and comprehensive
loss |
$ |
|
(22,824 |
) |
|
$ |
|
(11,733 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to
common stockholders |
$ |
|
(22,824 |
) |
|
$ |
|
(11,733 |
) |
|
Net loss per share
attributable to common stockholders |
$ |
|
(0.60 |
) |
|
$ |
|
(0.32 |
) |
|
Weighted-average shares used
in computing net loss per share attributable to common
stockholders, basic and diluted |
|
|
38,009,621 |
|
|
|
|
36,175,523 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes stock-based
compensation as follows |
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
|
915 |
|
|
$ |
|
452 |
|
|
General and administrative |
|
|
1,012 |
|
|
|
|
512 |
|
|
Total stock-based compensation expense |
$ |
|
1,927 |
|
|
$ |
|
964 |
|
EIDOS THERAPEUTICS,
INC.Condensed Balance
Sheets(Unaudited)(In
thousands)
|
March 31, |
|
|
December 31, |
|
|
|
|
|
|
|
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash |
$ |
|
196,515 |
|
|
$ |
|
191,157 |
|
Related party receivable |
|
|
125 |
|
|
|
|
85 |
|
Prepaid expenses and other current assets |
|
|
3,952 |
|
|
|
|
4,678 |
|
Total current assets |
|
|
200,592 |
|
|
|
|
195,920 |
|
Property and equipment,
net |
|
|
1,283 |
|
|
|
|
1,259 |
|
Operating lease, right of use
asset |
|
|
3,897 |
|
|
|
|
4,010 |
|
Other assets |
|
|
2,825 |
|
|
|
|
2,631 |
|
Total assets |
$ |
|
208,597 |
|
|
$ |
|
203,820 |
|
Liabilities and
Stockholders’
Equity |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
$ |
|
3,972 |
|
|
$ |
|
3,151 |
|
Related party payable |
|
|
323 |
|
|
|
|
316 |
|
Lease liabilities |
|
|
569 |
|
|
|
|
554 |
|
Accrued expenses and other current liabilities |
|
|
6,956 |
|
|
|
|
6,409 |
|
Total current liabilities |
|
|
11,820 |
|
|
|
|
10,430 |
|
Debt, non-current |
|
|
16,316 |
|
|
|
|
16,112 |
|
Lease liabilities,
non-current |
|
|
4,443 |
|
|
|
|
4,591 |
|
Embedded Derivative |
|
|
1,103 |
|
|
|
|
1,165 |
|
Other liabilities |
|
|
63 |
|
|
|
|
95 |
|
Total liabilities |
|
|
33,745 |
|
|
|
|
32,393 |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity
(deficit): |
|
|
|
|
|
|
|
|
|
Common stock |
|
|
39 |
|
|
|
|
38 |
|
Additional paid-in capital |
|
|
300,742 |
|
|
|
|
274,494 |
|
Accumulated deficit |
|
|
(125,929 |
) |
|
|
|
(103,105 |
) |
Total stockholders’ equity |
|
|
174,852 |
|
|
|
|
171,427 |
|
Total liabilities and
stockholders’ equity |
$ |
|
208,597 |
|
|
$ |
|
203,820 |
|
|
|
|
|
|
|
|
|
|
|
Media Contact:
Carolyn Hawley, Canale Communications, (619) 849-5382,
carolyn@canalecomm.com
For Investors
John Grimaldi, Burns McClellan, (212) 213-0006,
jgrimaldi@burnsmc.com
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