Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX), today reported its
financial results for the third quarter ended September 30, 2020
and provided an update on the company’s operations.
“The completion of enrollment in our Phase 3 ATTRibute-CM
clinical study marks the next milestone in the accelerated
development of acoramidis for patients with transthyretin (TTR)
amyloidosis (ATTR),” said Neil Kumar, PhD, chief executive officer
of Eidos. “Since originally licensing acoramidis from Stanford
University in 2016, we have endeavored to advance the molecule as
quickly as possible, knowing that every moment matters for the
patients and families suffering from this devastating disease. We
look forward to our top-line Phase 3 readout in just over a year
and are preparing to commercialize acoramidis globally if the trial
is successful.”
Company Operations
- Eidos completed screening in September for its pivotal Phase 3
ATTRibute-CM clinical trial of acoramidis in patients with ATTR
cardiomyopathy. The study enrolled more than 600 subjects with
either wild-type or variant TTR across more than 80 sites in 18
countries.
- Topline results from Part A of the ATTRibute-CM trial are
expected in late 2021 or early 2022 and from Part B in 2023. If
Part A is successful, the company intends to file for regulatory
approval of acoramidis in 2022.
- On October 5, 2020, Eidos entered into an agreement and plan of
merger providing for the acquisition by BridgeBio Pharma, Inc.
(“BridgeBio”) of all of the outstanding common stock of Eidos it
does not already own.
Third Quarter 2020 Financial and Operating
Results
Cash and cash equivalents totaled $147.3 million at September
30, 2020 compared with $191.2 million at December 31, 2019.
Eidos reported a net loss attributable to common stockholders of
approximately $30.2 million, or $0.79 per common
share, for the third quarter of 2020, as compared to a net
income attributable to common stockholders of $6.9 million, or
$0.19 per common share, for the third 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 pre-clinical
studies, and general and administrative expenses for operations.
The net income in third quarter 2019 was primarily driven by
revenue received under the company’s license agreement with Alexion
Pharma International Operations Unlimited Company, a subsidiary of
Alexion Pharmaceuticals, Inc., to develop, manufacture and
commercialize acoramidis in Japan.
Research and development expenses for the third quarter of 2020
were $22.6 million, as compared to $12.0 million for
the same period in the prior year. Research and development
expenses for the third quarter included costs related to contract
manufacturing and the preparation for, and increase in, activity
related to our clinical trials of acoramidis.
General and administrative expenses for the third quarter of
2020 were $7.0 million, as compared to $6.0
million for the same period in the prior year. The increase in
general and administrative expense in the third 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, a $0.8 million one-time charge related to the
acceleration of vesting of stock options for former directors, and
other administrative expenses.
Nine Months Ended
September 30,
2020 Financial
Results
Eidos reported a net loss attributable to common stockholders
of $81.8 million or $2.14 per common share, for the nine
months ended September 30, 2020, as compared to 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.
The increase in net loss attributable to common stockholders was
driven primarily by research and development expenses related to
acoramidis clinical trials and pre-clinical studies, and general
and administrative expenses for operations.
Research and development expenses for the nine months ended
September 30, 2020 were $58.1 million, as compared
to $33.0 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 nine months ended
September 30, 2020 were $22.6 million, as compared
to $12.3 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.
Company Update
On October 5, 2020, Eidos entered into an agreement and plan of
merger with BridgeBio, Globe Merger Sub I, Inc., an indirect
wholly-owned subsidiary of BridgeBio, and Globe Merger Sub II,
Inc., an indirect wholly-owned subsidiary of BridgeBio, providing
for the acquisition by BridgeBio of all of the outstanding common
stock of Eidos it does not already own, representing approximately
36.3% of the outstanding shares of Eidos common stock. Pursuant to
the merger agreement, Eidos stockholders will have the right to
receive in the transaction, at their election, either 1.85 shares
of BridgeBio common stock or $73.26 in cash per Eidos share upon
the closing of the transaction, subject to proration to ensure that
the aggregate amount of cash consideration is no greater than $175
million. Upon closing of the transaction and subject to the terms
of the merger agreement, Eidos will become an indirect wholly-owned
subsidiary of BridgeBio, and Eidos’ common stock will cease to
trade on the NASDAQ Global Select Market. The transaction is
subject to the receipt of stockholder approvals and the
satisfaction or waiver of other customary closing conditions.
Closing is expected to occur in the first quarter of 2021 subject
to the satisfaction or waiver of such closing conditions.
In connection with the execution of the merger agreement, Eidos
also entered into voting agreements with members of BridgeBio’s
board of directors and KKR Genetic Disorder L.P., collectively
owning approximately 36% of BridgeBio’s outstanding common stock,
pursuant to which they agreed, among other things, to vote their
shares in favor of the issuance of BridgeBio’s common stock in
connection with the transactions contemplated under the merger
agreement.
The foregoing descriptions of the merger agreement and the
voting agreements do not purport to be complete and are qualified
in their entirety by reference to the full text of the merger
agreement, a form of the voting agreements entered into by the
BridgeBio directors party thereto and the voting agreement entered
into by KKR Genetic Disorder L.P., copies of which were filed as
Exhibit 2.1, Exhibit 2.2 and Exhibit 2.3, respectively, to Eidos’
Form 8-K filed with the Securities and Exchange Commission, or SEC,
on October 7, 2020.
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 a Phase 3
clinical trial in patients with ATTR-PN (ATTRibute-PN). The company
currently expects to provide top-line data from Part A of the
ATTRibute-CM trial in late 2021 or early 2022.
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, our
ability to conduct and complete our Phase 3 clinical trials of
acoramidis in ATTR-CM and ATTR-PN in accordance with our plans, the
availability of top-line data from Part A of our Phase 3 clinical
trial of acoramidis in ATTR-CM, future clinical and regulatory
milestones of acoramidis, our ability to complete, and any effects
of, the proposed merger transaction with BridgeBio, 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, our dependence on third parties in connection with
our manufacturing, clinical trials
and pre-clinical studies, the occurrence of any event,
change or other circumstance that could give rise to the
termination of the proposed transaction with BridgeBio, the risk
that Eidos’ and/or BridgeBio’s stockholders may not approve the
proposed transaction, the inability to complete the proposed
transaction because, among other reasons, conditions to the closing
of the proposed transaction may not be satisfied or waived,
uncertainty as to the timing of completion of the proposed
transaction, potential adverse effects or changes to relationships
with employees, suppliers, strategic partners or other parties
resulting from the announcement or completion of the proposed
transaction, potential litigation relating to the proposed
transaction that could be instituted against Eidos, BridgeBio or
their respective directors and officers, including the effects of
any outcomes related thereto, possible disruptions from the
proposed transaction that could harm Eidos’ or BridgeBio’s
respective business, including current plans and operations,
unexpected costs, charges or expenses resulting from the proposed
transaction, uncertainty of the expected financial performance of
each of Eidos and BridgeBio following completion of the proposed
transaction, including the possibility that the expected synergies
and value creation from the proposed transaction will not be
realized or will not be realized within the expected time period.
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, 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.
Additional Information and Where to Find It
This release is being made in respect of the proposed
transaction involving Eidos and BridgeBio, which will be submitted
to Eidos’ and BridgeBio’s stockholders for their consideration.
BridgeBio intends to file a registration statement on Form S-4 with
the SEC, which will include a joint proxy statement of Eidos and
BridgeBio, and each party will file other documents regarding the
proposed transaction with the SEC. Any definitive proxy
statement(s) / prospectus(es) (if and when available) will also be
sent to the stockholders of Eidos and BridgeBio, when seeking any
required stockholder approval. This release does not constitute an
offer to sell or the solicitation of an offer to buy any securities
or a solicitation of any vote or approval. This release is not
intended to be, and is not, a substitute for such filings or for
any other document that Eidos or BridgeBio may file with the SEC in
connection with the proposed transaction. BEFORE MAKING ANY VOTING
OR INVESTMENT DECISION, INVESTORS AND SECURITY HOLDERS ARE URGED TO
CAREFULLY READ THE ENTIRE REGISTRATION STATEMENT(S) AND PROXY
STATEMENT(S) / PROSPECTUS(ES), WHEN THEY BECOME AVAILABLE, AND ANY
OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY
AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN
THEIR ENTIRETY BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION
ABOUT THE PROPOSED TRANSACTION. The documents filed or furnished by
Eidos and BridgeBio with the SEC may be obtained free of charge at
the SEC’s website at www.sec.gov. In addition, the documents filed
by Eidos may be obtained free of charge from Eidos at
www.Eidostx.com, under the tab “Investors” and the documents filed
by BridgeBio may be obtained free of charge from BridgeBio at
https://investor.bridgebio.com, under the tab “Financials &
Filings.” Alternatively, these documents, when available, can be
obtained free of charge from Eidos upon written request to Eidos at
101 Montgomery Street, Suite 2000, San Francisco, CA 94104, Attn:
John Grimaldi, Burns McClellan, or by calling 212-213-0006 or from
BridgeBio upon written request at 421 Kipling Street, Palo Alto, CA
94301, Attn: Grace Rauh, or by calling 917-232-5478.
Participants in the Solicitation
Eidos, BridgeBio and certain of their respective directors and
executive officers may be deemed to be participants in the
solicitation of proxies from stockholders of Eidos in connection
with the proposed transaction under the rules of the SEC. Investors
may obtain information regarding the names, affiliations and
interests of Eidos’ directors and executive officers in Eidos’
proxy statement for its 2020 annual meeting of stockholders, which
was filed with the SEC on April 24, 2020, as well as its other
filings with the SEC. Investors may obtain information regarding
the names, affiliations and interests of directors and executive
officers of BridgeBio in BridgeBio’s proxy statement for its 2020
annual meeting of stockholders, which was filed with the SEC on
April 22, 2020, as well as its other filings with the SEC. Other
information regarding the participants in the proxy solicitation
and a description of their direct and indirect interests, by
security holdings or otherwise, will be included in the
registration statement, joint proxy statement / prospectus and
other relevant materials to be filed with the SEC regarding the
proposed transaction (if and when they become available). You may
obtain free copies of these documents at the SEC’s website at
www.sec.gov. Copies of documents filed with the SEC by Eidos and
BridgeBio will also be available free of charge from Eidos or
BridgeBio, as applicable, using the contact information above.
No Offer or Solicitation
This material is not intended to and does not constitute an
offer to sell or the solicitation of an offer to buy, sell or
solicit any securities or any proxy, vote or approval in any
jurisdiction pursuant to or in connection with the proposed
transaction or otherwise, nor shall there be any sale of securities
in any jurisdiction in which such offer, solicitation or sale would
be unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offer of securities
shall be deemed to be made except by means of a prospectus meeting
the requirements of Section 10 of the Securities Act.
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, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
License revenue |
$ |
127 |
|
|
$ |
26,691 |
|
|
$ |
127 |
|
|
$ |
26,691 |
|
Operating
expenses*: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of license revenue |
$ |
- |
|
|
$ |
2,500 |
|
|
$ |
- |
|
|
$ |
2,500 |
|
Research and development |
|
22,568 |
|
|
|
11,987 |
|
|
|
58,067 |
|
|
|
33,033 |
|
General and
administrative |
|
6,962 |
|
|
|
5,953 |
|
|
|
22,590 |
|
|
|
12,285 |
|
Total operating expenses |
|
29,530 |
|
|
|
20,440 |
|
|
|
80,657 |
|
|
|
47,818 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations |
|
(29,403 |
) |
|
|
6,251 |
|
|
|
(80,530 |
) |
|
|
(21,127 |
) |
Interest expense |
|
(766 |
) |
|
|
- |
|
|
|
(1,888 |
) |
|
|
- |
|
Other income (expense), net |
|
(7 |
) |
|
|
680 |
|
|
|
569 |
|
|
|
2,272 |
|
Net income (loss) and
comprehensive income (loss) |
$ |
(30,176 |
) |
|
$ |
6,931 |
|
|
$ |
(81,849 |
) |
|
$ |
(18,855 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable
to common stockholders |
$ |
(30,176 |
) |
|
$ |
6,931 |
|
|
$ |
(81,849 |
) |
|
$ |
(18,855 |
) |
Net income (loss) per share
attributable to common stockholders, basic |
$ |
(0.79 |
) |
|
$ |
0.19 |
|
|
$ |
(2.14 |
) |
|
$ |
(0.52 |
) |
Net income (loss) per share
attributable to common stockholders, diluted |
$ |
(0.79 |
) |
|
$ |
0.18 |
|
|
$ |
(2.14 |
) |
|
$ |
(0.52 |
) |
Weighted-average shares used
in computing net loss per share attributable to common
stockholders, basic |
|
38,388,579 |
|
|
|
36,581,786 |
|
|
|
38,230,218 |
|
|
|
36,356,675 |
|
Weighted-average shares used
in computing net loss per share attributable to common
stockholders, diluted |
|
38,388,579 |
|
|
|
37,710,734 |
|
|
|
38,230,218 |
|
|
|
36,356,675 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes stock-based
compensation as follows |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
1,648 |
|
|
$ |
626 |
|
|
$ |
4,011 |
|
|
$ |
1,630 |
|
General and administrative |
|
1,792 |
|
|
|
969 |
|
|
|
4,074 |
|
|
|
2,095 |
|
Total stock-based compensation expense |
$ |
3,440 |
|
|
$ |
1,595 |
|
|
$ |
8,085 |
|
|
$ |
3,725 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EIDOS THERAPEUTICS,
INC.Condensed Balance
Sheets(Unaudited)(In
thousands)
|
September 30, |
|
|
December 31, |
|
|
|
|
|
|
|
|
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash |
$ |
147,327 |
|
|
$ |
191,157 |
|
Related party receivable |
|
240 |
|
|
|
85 |
|
Prepaid expenses and other current assets |
|
5,981 |
|
|
|
4,678 |
|
Total current assets |
|
153,548 |
|
|
|
195,920 |
|
Property and equipment,
net |
|
1,348 |
|
|
|
1,259 |
|
Operating lease, right of use
asset |
|
3,664 |
|
|
|
4,010 |
|
Other assets |
|
2,791 |
|
|
|
2,631 |
|
Total assets |
$ |
161,351 |
|
|
$ |
203,820 |
|
Liabilities and
Stockholders’
Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
2,381 |
|
|
$ |
3,151 |
|
Related party payable |
|
374 |
|
|
|
316 |
|
Lease liabilities |
|
599 |
|
|
|
554 |
|
Accrued expenses and other current liabilities |
|
10,473 |
|
|
|
6,409 |
|
Total current liabilities |
|
13,827 |
|
|
|
10,430 |
|
Debt, non-current |
|
16,731 |
|
|
|
16,112 |
|
Lease liabilities,
non-current |
|
4,137 |
|
|
|
4,591 |
|
Embedded Derivative |
|
1,300 |
|
|
|
1,165 |
|
Other liabilities |
|
2,500 |
|
|
|
95 |
|
Total liabilities |
|
38,495 |
|
|
|
32,393 |
|
|
|
|
|
|
|
|
|
Stockholders’ equity
(deficit): |
|
|
|
|
|
|
|
Common stock |
|
39 |
|
|
|
38 |
|
Additional paid-in capital |
|
307,771 |
|
|
|
274,494 |
|
Accumulated deficit |
|
(184,954 |
) |
|
|
(103,105 |
) |
Total stockholders’ equity |
|
122,856 |
|
|
|
171,427 |
|
Total liabilities and
stockholders’ equity |
$ |
161,351 |
|
|
$ |
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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