eidx-8k_20190801.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 1, 2019

 

EIDOS THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-38533

46-3733671

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

 

Eidos Therapeutics, Inc.

101 Montgomery Street, Suite 2550

San Francisco, CA 94104

(Address of principal executive offices, including zip code)

(415) 887-1471

(Telephone number, including area code, of agent for service)

 

Not Applicable

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 


Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock

EIDX

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

 

 

 


Item 2.02. Results of Operations and Financial Condition.

 

On August 1, 2019, Eidos Therapeutics, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2019. A copy of the press release issued in connection with the announcement is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.

 

The information in this report, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Eidos Therapeutics, Inc. under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit

Number

 

Description

99.1

 

Press Release dated August 1, 2019 titled “Eidos Therapeutics Reports Second Quarter 2019 Financial Results”

 

 

 

 

 

 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

Eidos Therapeutics, Inc.

 

 

 

 

Date: August 1, 2019

 

By:

/s/ Christine Siu

 

 

 

Christine Siu

 

 

 

Chief Financial Officer

 

eidx-ex991_6.htm

Exhibit 99.1

Eidos Therapeutics Reports Second Quarter 2019 Financial Results

 

 

SAN FRANCISCO, August 1, 2019 — Eidos Therapeutics, Inc. (Eidos) (Nasdaq: EIDX), today reported its financial results for the second quarter ended June 30, 2019 and provided an update on the company’s recent achievements.

 

“We remain focused on executing our Phase 3 program studying AG10 in patients with (TTR) amyloidosis (ATTR),” said Neil Kumar PhD, chief executive officer of Eidos. “Our Phase 3 trial in patients with ATTR cardiomyopathy is now enrolling in both the United States and Europe, and we plan to initiate our Phase 3 trial in patients with ATTR polyneuropathy before the end of the year. We believe that these studies will provide compelling evidence that AG10 could be an effective treatment for patients suffering from this lethal, debilitating disease.”

 

Recent Achievements and Upcoming Milestones

Enrolling Phase 3 study of AG10 in ATTR-CM (ATTRibute-CM)

Published Phase 1 data of AG10 in healthy volunteers in Clinical Pharmacology in Drug Development

Plan to initiate Phase 3 study of AG10 in ATTR-PN (ATTRibute-PN) in the second half of 2019

Plan to present data from the open label extension of the Phase 2 study of AG10 in ATTR-CM in the fourth quarter of 2019

 

Second Quarter Financial Results

 

Cash and cash equivalents totaled $131.4 million at June 30, 2019 compared with $157.1 million at December 31, 2018.

 

Eidos reported a net loss attributable to common stockholders of $14.1 million or $0.39 per common share, for the second quarter of 2019, as compared to a net loss attributable to common stockholders of $11.4 million or $1.40 per common share for the second quarter of 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 second quarter of 2019 were $12.5 million, as compared to $6.2 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 second quarter of 2019 were $2.3 million, as compared to $1.9 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.

 

Six Months Ended June 30, 2019 Financial Results

 

Eidos reported 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, as compared to a net loss attributable to common stockholders of $19.3 million or $3.06 per common share for the six months ended June 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 six months ended June 30, 2019 were $21.0 million, as compared to $11.8 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, 2019 were $6.3 million, as compared to $4.2 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, 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 June 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

 

 

 

Six months ended

 

 

 

 

 

June 30,

 

 

 

June 30,

 

 

 

 

 

2019

 

 

 

2018

 

 

 

2019

 

 

 

2018

 

 

 

Operating expenses*:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

$

 

12,497

 

 

$

 

6,195

 

 

$

 

21,046

 

 

$

 

11,847

 

 

 

General and administrative

 

 

2,297

 

 

 

 

1,894

 

 

 

 

6,332

 

 

 

 

4,239

 

 

 

           Total operating expenses

 

 

14,794

 

 

 

 

8,089

 

 

 

 

27,378

 

 

 

 

16,086

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(14,794

)

 

 

 

(8,089

)

 

 

 

(27,378

)

 

 

 

(16,086

)

 

 

      Other income (expense), net

 

 

741

 

 

 

 

(3,292

)

 

 

 

1,592

 

 

 

 

(4,171

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net and comprehensive loss

 

 

(14,053

)

 

 

 

(11,381

)

 

 

 

(25,786

)

 

 

 

(20,257

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 loss attributable to common stockholders

$

 

(14,053

)

 

$

 

(11,381

)

 

$

 

(25,786

)

 

$

 

(19,344

)

 

 

Net loss per share attributable to common stockholders, basic and diluted

$

 

(0.39

)

 

$

 

(1.40

)

 

$

 

(0.71

)

 

$

 

(3.06

)

 

 

Weighted-average shares used in computing net loss

   per share attributable to common stockholders, basic

   and diluted

 

 

36,309,740

 

 

 

 

8,109,653

 

 

 

 

36,242,814

 

 

 

 

6,328,827

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

* Includes stock-based compensation as follows

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

      Research and development

$

 

552

 

 

$

 

443

 

 

$

 

1,004

 

 

$

 

621

 

 

 

      General and administrative

 

 

614

 

 

 

 

176

 

 

 

 

1,126

 

 

 

 

386

 

 

 

           Total stock-based compensation expense

$

 

1,166

 

 

$

 

619

 

 

$

 

2,130

 

 

$

 

1,007

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



EIDOS THERAPEUTICS, INC.

Condensed Balance Sheets

(Unaudited)

(In thousands)

 

 

 

June 30,

 

 

December 31,

 

 

2019

 

 

2018

 

Assets

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

      Cash and cash equivalents

$

 

131,400

 

 

$

 

157,147

 

      Related party receivable

 

 

197

 

 

 

 

34

 

      Prepaid expenses and other current assets

 

 

3,928

 

 

 

 

1,789

 

           Total current assets

 

 

135,525

 

 

 

 

158,970

 

Property and equipment, net

 

 

204

 

 

 

 

209

 

Operating lease, right of use asset

 

 

988

 

 

 

 

-

 

Other assets

 

 

2,564

 

 

 

 

933

 

           Total assets

$

 

139,281

 

 

$

 

160,112

 

Liabilities, Redeemable Convertible Preferred Stock and

   Stockholders’ Equity

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

      Accounts payable

$

 

1,842

 

 

$

 

1,956

 

      Related party payable

 

 

344

 

 

 

 

256

 

      Lease liabilities

 

 

276

 

 

 

 

-

 

      Accrued expenses and other current liabilities

 

 

4,027

 

 

 

 

2,577

 

           Total current liabilities

 

 

6,489

 

 

 

 

4,789

 

Other liabilities

 

 

164

 

 

 

 

316

 

Lease liabilities, non-current

 

 

782

 

 

 

 

-

 

           Total liabilities

 

 

7,435

 

 

 

 

5,105

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

 

Preferred stock

 

 

-

 

 

 

 

-

 

Common stock

 

 

37

 

 

 

 

37

 

      Additional paid-in capital

 

 

222,865

 

 

 

 

220,240

 

      Accumulated deficit

 

 

(91,056

)

 

 

 

(65,270

)

           Total stockholders’ equity

 

 

131,846

 

 

 

 

155,007

 

Total liabilities, redeemable convertible preferred stock and stockholders’

   equity

$

 

139,281

 

 

$

 

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