Eidos Therapeutics Reports Third Quarter 2020 Financial Results and Business Update
“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
- 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.
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
Eidos reported a net loss attributable to common stockholders of approximately $30.2 million, or
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
Nine Months Ended September 30, 2020 Financial Results
Eidos reported a net loss attributable to common stockholders of $81.8 million or
Research and development expenses for the nine months ended
General and administrative expenses for the nine months ended
In connection with the execution of the merger agreement, Eidos also entered into voting agreements with members of BridgeBio’s board of directors and
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
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.
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
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
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
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.
Condensed Statements of Operations
(In thousands, except share and per share data)
|Three Months Ended||Nine Months Ended|
|Cost of license revenue||$||-||$||2,500||$||-||$||2,500|
|Research and development||22,568||11,987||58,067||33,033|
|General and administrative||6,962||5,953||22,590||12,285|
|Total operating expenses||29,530||20,440||80,657||47,818|
|Income (loss) from operations||(29,403||)||6,251||(80,530||)||(21,127||)|
|Other income (expense), net||(7||)||680||569||2,272|
|Net income (loss) and comprehensive income (loss)||$||(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||$||3,725|
Condensed Balance Sheets
|Related party receivable||240||85|
|Prepaid expenses and other current assets||5,981||4,678|
|Total current assets||153,548||195,920|
|Property and equipment, net||1,348||1,259|
|Operating lease, right of use asset||3,664||4,010|
|Liabilities and Stockholders’ Equity|
|Related party payable||374||316|
|Accrued expenses and other current liabilities||10,473||6,409|
|Total current liabilities||13,827||10,430|
|Lease liabilities, non-current||4,137||4,591|
|Stockholders’ equity (deficit):|
|Additional paid-in capital||307,771||274,494|
|Total stockholders’ equity||122,856||171,427|
|Total liabilities and stockholders’ equity||$||161,351||$||203,820|
Source: Eidos Therapeutics, Inc.