Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX), today
reported its financial results for the second quarter ended June
30, 2020 and provided an update on the company’s operations.
“While the COVID-19 pandemic poses an unpredictable
threat to our clinical development program, our team continues to
work tirelessly with the ATTR patient community, our investigators
and collaborators, and regulators to ensure the progression and
integrity of our trials,” said Neil Kumar, PhD, chief executive
officer of Eidos. “Though the situation is far from resolved, we
are incredibly grateful to these groups for their commitment to our
program and are encouraged to have observed a re-opening of
clinical research activities worldwide in recent months. The
determination and resilience of this community inspires our efforts
to develop acoramidis (formerly AG10) as a potentially
best-in-class treatment option for ATTR patients.”
Acoramidis selected as non-proprietary name
for AG10
The International Nonproprietary Naming Committee
of the World Health Organization (WHO) has selected acoramidis
(pronounced “a kor am' i dis”) as the proposed International
Nonproprietary Name, or pINN, for the company’s lead product
candidate, AG10. The established suffix “-amidis” was utilized to
convey the molecule’s proposed mode of action to inhibit amyloid
deposition.
WHO’s INN Expert Group assigns simple, informative
and unique nonproprietary names for drugs to allow for clear
communication among health professionals and to identify
chemical/pharmacological relationships. Eidos will use “acoramidis”
in upcoming presentations, publications and public statements as
the company continues progressing toward commercialization of the
product.
Update on Company Operations
The Company expects enrollment of patients in its
Phase 3 clinical trial of acoramidis in ATTR-CM patients
(ATTRibute-CM) to be completed in the first half of 2021 and the
Company plans to initiate a Phase 3 study of acoramidis in ATTR-PN
(ATTRibute-PN) in the second half of 2020.
Second Quarter 2020 Financial and Operating
Results
Cash and cash equivalents totaled $174.8 million at
June 30, 2020 compared with $191.2 million at December 31,
2019.
Eidos reported a net loss attributable to common
stockholders of approximately $28.8 million or $0.76 per
common share, for the second quarter of 2020, as compared to a
net loss attributable to common stockholders of $14.1 million
or $0.39 per common share, for the second quarter of 2019. The
increase in net loss attributable to common stockholders was driven
primarily by research and development expenses related to
acoramidis (formerly AG10) clinical trials and other pre-clinical
studies, and general and administrative expenses for
operations.
Research and development expenses for the second
quarter of 2020 were $17.9 million, as compared to $12.5
million for the same period in the prior year. Research and
development expenses for the second quarter included costs related
to contract manufacturing and the preparation for and conduct of
clinical trials of acoramidis.
General and administrative expenses for the second
quarter of 2020 were $10.3 million, as compared to $2.3
million for the same period in the prior year. The increase in
general and administrative expense in the second quarter of 2020
was due primarily to an increase in financial advisory consulting
services, 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.
Six Months Ended June 30, 2020 Financial
Results
Eidos reported a net loss attributable to common
stockholders of $51.7 million or $1.35 per common share,
for the six months ended June 30, 2020, as compared to a net loss
attributable to common stockholders of $25.8 million or $0.71
per common share for the six months ended June 30, 2019. The
increase in net loss attributable to common stockholders was driven
primarily by research and development expenses related to
acoramidis clinical trials and other pre-clinical studies, and
general and administrative expenses for operations.
Research and development expenses for the six
months ended June 30, 2020 were $35.5 million, as
compared to $21.0 million for the same period in the
prior year. Research and development expenses for the period
included costs related to contract manufacturing, and the
preparation for, and the increase in, activity
related to our clinical trials.
General and administrative expenses for the six
months ended June 30, 2020 were $15.6 million, as compared
to $6.3 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 financial advisory consulting
services, 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 acoramidis
Acoramidis (formerly 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, acoramidis 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 acoramidis Phase 2 OLE.
Acoramidis 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 acoramidis in
patients with ATTR-PN (ATTRibute-PN) in the second half of
2020.
Acoramidis 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,
acoramidis 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 acoramidis, 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 acoramidis, the
impact of the COVID-19 pandemic on our research and development
activities and other business operations, our ability to complete
the enrollment of patients in and conduct the ATTRibute-CM trial
and to initiate and conduct our planned Phase 3 clinical trial of
acoramidis in ATTR-PN in accordance with our plans, future clinical
and regulatory milestones of acoramidis, 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 acoramidis through current and
future milestones, our ability to raise additional funding to
complete the development of acoramidis, our dependence on the
success of acoramidis, 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 acoramidis 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 June 30, 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)
|
|
|
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|
|
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Three Months Ended |
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
|
June 30, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Research and development |
$ |
|
17,924 |
|
|
$ |
|
12,497 |
|
|
$ |
|
35,499 |
|
|
$ |
|
21,046 |
|
General and administrative |
|
|
10,317 |
|
|
|
|
2,297 |
|
|
|
|
15,628 |
|
|
|
|
6,332 |
|
Total operating expenses |
|
|
28,241 |
|
|
|
|
14,794 |
|
|
|
|
51,127 |
|
|
|
|
27,378 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(28,241 |
) |
|
|
|
(14,794 |
) |
|
|
|
(51,127 |
) |
|
|
|
(27,378 |
) |
Interest expense |
|
|
(604 |
) |
|
|
|
- |
|
|
|
|
(1,122 |
) |
|
|
|
- |
|
Other income (expense), net |
|
|
(4 |
) |
|
|
|
741 |
|
|
|
|
576 |
|
|
|
|
1,592 |
|
Net and comprehensive loss |
$ |
|
(28,849 |
) |
|
$ |
|
(14,053 |
) |
|
$ |
|
(51,673 |
) |
|
$ |
|
(25,786 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders |
$ |
|
(28,849 |
) |
|
$ |
|
(14,053 |
) |
|
$ |
|
(51,673 |
) |
|
$ |
|
(25,786 |
) |
Net loss per share attributable to common stockholders |
$ |
|
(0.75 |
) |
|
$ |
|
(0.39 |
) |
|
$ |
|
(1.35 |
) |
|
$ |
|
(0.71 |
) |
Weighted-average shares used in computing net loss per share
attributable to common stockholders, basic and diluted |
|
|
38,291,414 |
|
|
|
|
36,309,740 |
|
|
|
|
38,150,520 |
|
|
|
|
36,242,814 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
* Includes stock-based
compensation as follows |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
|
1,448 |
|
|
$ |
|
552 |
|
|
$ |
|
2,363 |
|
|
$ |
|
1,004 |
|
General and administrative |
|
|
1,270 |
|
|
|
|
614 |
|
|
|
|
2,282 |
|
|
|
|
1,126 |
|
Total stock-based compensation expense |
$ |
|
2,718 |
|
|
$ |
|
1,166 |
|
|
$ |
|
4,645 |
|
|
$ |
|
2,130 |
|
|
EIDOS THERAPEUTICS,
INC.Condensed Balance
Sheets(Unaudited)(In
thousands)
|
June 30, |
|
|
December 31, |
|
|
|
|
|
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash |
$ |
174,821 |
|
|
$ |
191,157 |
|
Related party receivable |
|
154 |
|
|
|
85 |
|
Prepaid expenses and other current assets |
|
3,818 |
|
|
|
4,678 |
|
Total current assets |
|
178,793 |
|
|
|
195,920 |
|
Property and equipment,
net |
|
1,317 |
|
|
|
1,259 |
|
Operating lease, right of use
asset |
|
3,781 |
|
|
|
4,010 |
|
Other assets |
|
2,779 |
|
|
|
2,631 |
|
Total assets |
$ |
186,670 |
|
|
$ |
203,820 |
|
Liabilities and
Stockholders’
Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
2,240 |
|
|
$ |
3,151 |
|
Related party payable |
|
359 |
|
|
|
316 |
|
Lease liabilities |
|
584 |
|
|
|
554 |
|
Accrued expenses and other current liabilities |
|
12,206 |
|
|
|
6,409 |
|
Total current liabilities |
|
15,389 |
|
|
|
10,430 |
|
Debt, non-current |
|
16,522 |
|
|
|
16,112 |
|
Lease liabilities,
non-current |
|
4,293 |
|
|
|
4,591 |
|
Embedded Derivative |
|
1,124 |
|
|
|
1,165 |
|
Other liabilities |
|
31 |
|
|
|
95 |
|
Total liabilities |
|
37,359 |
|
|
|
32,393 |
|
|
|
|
|
|
|
|
|
Stockholders’ equity
(deficit): |
|
|
|
|
|
|
|
Common stock |
|
39 |
|
|
|
38 |
|
Additional paid-in capital |
|
304,050 |
|
|
|
274,494 |
|
Accumulated deficit |
|
(154,778 |
) |
|
|
(103,105 |
) |
Total stockholders’ equity |
|
149,311 |
|
|
|
171,427 |
|
Total liabilities and
stockholders’ equity |
$ |
186,670 |
|
|
$ |
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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