Eidos Therapeutics, Inc. (Eidos) (Nasdaq: EIDX), a subsidiary of
BridgeBio Pharma, Inc. (BridgeBio) (Nasdaq:BBIO), today reported
its financial results for the third quarter ended September 30,
2019 and provided an update on the company’s recent achievements,
upcoming events and chief financial officer transition plan.
“We continue to focus on executing our Phase 3 program studying
AG10 in patients with transthyretin (TTR) amyloidosis (ATTR). Our
phase 3 study in ATTR-cardiomyopathy (ATTR-CM) is enrolling
patients in the US and Europe. We look forward to presenting data
from the Phase 2 open label extension study at the American Heart
Association (AHA),” said Neil Kumar, Ph.D., chief executive officer
of Eidos. “In addition, we executed a partnership with Alexion this
quarter to develop and commercialize AG10 in Japan. This
partnership brings regional resources and expertise to accelerate
AG10’s development path in Japan.”
Recent Achievements and Upcoming Milestones
- Granted Alexion Pharmaceuticals, Inc. an exclusive license to
develop and commercialize AG10 in Japan for an upfront payment of
$25 million and an equity investment of $25 million.
- Continued enrollment in Phase 3 study of AG10 in ATTR-CM
(ATTRibute-CM).
- Plan to present 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.
- Plan to initiate Phase 3 study of AG10 in ATTR-PN
(ATTRibute-PN) in the first quarter of 2020.
Eidos also announced the transition plan of Christine Siu, chief
financial officer. Ms. Siu will remain chief financial officer of
Eidos until December 31, 2019, when she will transition to a senior
role at Eidos’ parent company, BridgeBio. Franco Valle, Eidos’
current vice president of finance, is expected to continue leading
financial operations as senior vice president of finance and
principal accounting officer thereafter. “On behalf of the entire
Board and executive team, I would like to thank Christine for her
contributions and leadership since we founded Eidos in 2016. She
has played an invaluable role in transforming the company since its
founding and I look forward to continue working together at
BridgeBio,” said Dr. Kumar, chief executive officer of Eidos and
BridgeBio. “It has been a rewarding experience to serve as the CFO
of Eidos,” said Ms. Siu. “I am proud of the Eidos team and the
progress we have made bringing AG10 closer to ATTR patients in
need. I believe Eidos has great potential and I look forward to
continue working with the team through the parent company,
BridgeBio.”
Third Quarter Financial Results
Cash and cash equivalents totaled $165.8 million at September
30, 2019 compared with $157.1 million at December 31, 2018.
Eidos reported a net income attributable to common stockholders
of $6.9 million or $0.19 per common share, for the third
quarter of 2019, as compared to a net loss attributable to common
stockholders of $10.6 million or $0.30 per common
share for the third quarter of 2018. The increase in net
income attributable to common stockholders was driven primarily by
revenue received from Alexion offset 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 third quarter of 2019
were $12.0 million, as compared to $8.4 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 third quarter of
2019 were $6.0 million, as compared to $2.6
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 one-time charges, 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.
Nine Months Ended September 30, 2019 Financial
Results
Eidos reported a net loss attributable to common stockholders
of $18.9 million or $0.52 per common share, for the nine
months ended September 30, 2019, as compared to a net loss
attributable to common stockholders of $30.0 million or $1.83
per common share for the nine months ended September 30, 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 nine months ended
September 30, 2019 were $33.0 million, as compared
to $20.2 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 nine months ended
September 30, 2019 were $12.3 million, as compared
to $6.9 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 is ongoing 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, our ability
to enroll patients in and conduct the ATTRibute-CM trial in
accordance with our plans, our plan to initiate a Phase 3 study of
AG10 in ATTR-PN, our ability to generate data from the open label
extension of our Phase 2 study of AG10 in ATTR-CM, future clinical
and regulatory milestones of AG10, our chief financial officer
transition plan, 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 September 30,
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 |
|
|
|
Nine months ended |
|
|
|
September 30, |
|
|
|
September 30, |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
License
revenue |
$ |
26,691 |
|
|
$ |
- |
|
|
$ |
26,691 |
|
|
$ |
- |
|
Operating expenses*: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of license revenue |
|
2,500 |
|
|
|
|
|
|
|
2,500 |
|
|
|
|
|
Research and development |
|
11,987 |
|
|
|
8,369 |
|
|
|
33,033 |
|
|
|
20,216 |
|
General and administrative |
|
5,953 |
|
|
|
2,619 |
|
|
|
12,285 |
|
|
|
6,858 |
|
Total operating expenses |
|
20,440 |
|
|
|
10,988 |
|
|
|
47,818 |
|
|
|
27,074 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
6,251 |
|
|
|
(10,988 |
) |
|
|
(21,127 |
) |
|
|
(27,074 |
) |
Other income (expense), net |
|
680 |
|
|
|
374 |
|
|
|
2,272 |
|
|
|
(3,797 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) and comprehensive income (loss) |
|
6,931 |
|
|
|
(10,614 |
) |
|
|
(18,855 |
) |
|
|
(30,871 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 income (loss) attributable to common stockholders |
$ |
6,931 |
|
|
$ |
(10,614 |
) |
|
$ |
(18,855 |
) |
|
$ |
(29,958 |
) |
Net income (loss) per share attributable to common stockholders,
basic |
$ |
0.19 |
|
|
$ |
(0.30 |
) |
|
$ |
(0.52 |
) |
|
$ |
(1.83 |
) |
Net income (loss) per share attributable to common stockholders,
diluted |
$ |
0.18 |
|
|
$ |
(0.30 |
) |
|
$ |
(0.52 |
) |
|
$ |
(1.83 |
) |
Weighted-average shares used in computing net income
(loss) per share attributable to common stockholders,
basic |
|
36,581,786 |
|
|
|
35,965,790 |
|
|
|
36,356,675 |
|
|
|
16,361,349 |
|
Weighted-average shares used in computing net income
(loss) per share attributable to common stockholders,
diluted |
|
37,710,734 |
|
|
|
35,965,790 |
|
|
|
36,356,675 |
|
|
|
16,361,349 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes stock-based compensation as
follows |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
626 |
|
|
$ |
251 |
|
|
$ |
1,630 |
|
|
$ |
872 |
|
General and administrative |
|
969 |
|
|
|
443 |
|
|
|
2,095 |
|
|
|
829 |
|
Total stock-based compensation expense |
$ |
1,595 |
|
|
$ |
694 |
|
|
$ |
3,725 |
|
|
$ |
1,701 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EIDOS THERAPEUTICS,
INC.Condensed Balance
Sheets(Unaudited)(In
thousands)
|
September 30, |
|
|
December 31, |
|
|
2019 |
|
|
2018 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
165,822 |
|
|
$ |
157,147 |
|
Related party receivable |
|
83 |
|
|
|
34 |
|
Prepaid expenses and other current assets |
|
5,402 |
|
|
|
1,789 |
|
Total current assets |
|
171,307 |
|
|
|
158,970 |
|
Property and equipment,
net |
|
1,199 |
|
|
|
209 |
|
Operating lease, right of use
asset |
|
4,121 |
|
|
|
- |
|
Other assets |
|
2,267 |
|
|
|
933 |
|
Total assets |
$ |
178,894 |
|
|
$ |
160,112 |
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
3,567 |
|
|
$ |
1,956 |
|
Related party payable |
|
372 |
|
|
|
256 |
|
Lease liabilities |
|
471 |
|
|
|
- |
|
Accrued expenses and other current liabilities |
|
5,665 |
|
|
|
2,577 |
|
Total current liabilities |
|
10,075 |
|
|
|
4,789 |
|
Other liabilities |
|
129 |
|
|
|
316 |
|
Lease liabilities,
non-current |
|
4,736 |
|
|
|
- |
|
Total liabilities |
|
14,940 |
|
|
|
5,105 |
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Preferred stock |
|
- |
|
|
|
- |
|
Common stock |
|
38 |
|
|
|
37 |
|
Additional paid-in capital |
|
248,041 |
|
|
|
220,240 |
|
Accumulated deficit |
|
(84,125 |
) |
|
|
(65,270 |
) |
Total stockholders’ equity |
|
163,954 |
|
|
|
155,007 |
|
Total liabilities and
stockholders’ equity |
$ |
178,894 |
|
|
$ |
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
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