Eton Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results and Highlights Business Progress
“2018 was an important year in Eton’s history as we made tremendous progress both clinically and operationally, including the successful completion of our IPO. The momentum has continued into 2019, as we have already executed three significant transactions this year, including Bausch Health’s acquisition of EM-100, and we now have a total of four product candidates filed with the FDA,” said
Business Updates:
- NDA filing for ET-202 accepted for review by
FDA .The U.S. Food and Drug Administration (FDA ) has accepted for review the New Drug Application (NDA) for ET-202. The product candidate has been assigned a PDUFA target action date ofOctober 21, 2019 . Eton has begun preparing for a commercial launch internally. - First patient dosed for ET-103 clinical study. Eton dosed the first patient in its clinical study for ET-103. Results are expected in the third quarter of 2019, and, if successful, Eton anticipates an NDA submission before year end 2019.
- Patent application filed for ET-104. A patent application was filed for ET-104, Eton’s recently acquired innovative oral liquid product candidate for the treatment of a neurological condition. A clinical study of ET-104 is expected to initiate in the second quarter of 2019. If successful, Eton anticipates an NDA submission before year end 2019.
- Established Internal R&D laboratory. Eton has begun testing in its new, state of the art Research and Development (R&D) laboratory in
Lake Zurich, Illinois . The addition of this facility provides Eton with internal capabilities for analytical testing activities and product development.
Fourth Quarter and Full Year 2018 Financial Results
Cash Position: As of
Research and Development (R&D) Expenses: R&D expenses were
General & Administrative (G&A) Expenses: G&A expenses were
Net Loss: Eton reported a net loss for the fourth quarter of 2018 of
About
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
| Eton Pharmaceuticals, Inc. | ||||||||||||||||
| Statements of Operations | ||||||||||||||||
| (In thousands, except per share amounts) | ||||||||||||||||
| Three months ended December 31, (Unaudited) |
Year ended December 31, |
Period from April 27, 2017 (Inception) to December 31, |
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| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 1,102 | $ | 863 | $ | 5,627 | $ | 3,930 | ||||||||
| General and administrative | 1,184 | 1,333 | 4,694 | 3,220 | ||||||||||||
| Total operating expenses | 2,286 | 2,196 | 10,321 | 7,150 | ||||||||||||
| Loss from operations | (2,286 | ) | (2,196 | ) | (10,321 | ) | (7,150 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income, net | 82 | 26 | 164 | 35 | ||||||||||||
| Change in fair value of warrant liability | (1,526 | ) | — | (2,583 | ) | (41 | ) | |||||||||
| Loss before income tax expense | (3,730 | ) | (2,170 | ) | (12,740 | ) | (7,156 | ) | ||||||||
| Income tax expense | — | — | — | — | ||||||||||||
| Net loss | (3,730 | ) | (2,170 | ) | (12,740 | ) | (7,156 | ) | ||||||||
| Accrued dividends on redeemable convertible preferred stock | (148 | ) | (300 | ) | (1,048 | ) | (643 | ) | ||||||||
| Deemed dividends for accretion of redeemable convertible preferred stock issuance costs | (437 | ) | (401 | ) | (1,694 | ) | (840 | ) | ||||||||
| Deemed dividends for beneficial conversion feature of redeemable convertible preferred stock | (21,747 | ) | — | (21,747 | ) | — | ||||||||||
| Net loss attributable to common stockholders | $ | (26,062 | ) | $ | (2,871 | ) | $ | (37,229 | ) | $ | (8,639 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (2.24 | ) | $ | (0.81 | ) | $ | (5.80 | ) | $ | (2.50 | ) | ||||
| Weighted-average number of common shares outstanding, basic and diluted | 11,640 | 3,525 | 6,418 | 3,453 | ||||||||||||
| Eton Pharmaceuticals, Inc. | ||||||||
| Balance Sheets | ||||||||
| (in thousands, except share and per share amounts) | ||||||||
| December 31, 2018 |
December 31, 2017 |
|||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 26,735 | $ | 13,156 | ||||
| Prepaid expenses | 767 | 136 | ||||||
| Total current assets | 27,502 | 13,292 | ||||||
| Property and equipment, net | 773 | 119 | ||||||
| Other long-term assets, net | 52 | 32 | ||||||
| Total assets | $ | 28,327 | $ | 13,443 | ||||
| Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,421 | $ | 539 | ||||
| Accrued liabilities | 603 | 254 | ||||||
| Total current liabilities | 2,024 | 793 | ||||||
| Warrant liability | — | 520 | ||||||
| Total liabilities | 2,024 | 1,313 | ||||||
| Commitments and contingencies | ||||||||
| Redeemable convertible preferred stock – Series A | ||||||||
| $0.001 par value, 10,000,000 shares authorized as of December 31, 2018 and 2017; no shares and 6,685,082 shares issued and outstanding as of December 31, 2018 and 2017, respectively; aggregate liquidation preference of $0 and $20,698 as of December 31, 2018 and 2017, respectively |
— | 19,004 | ||||||
| Stockholders’ equity (deficit) | ||||||||
| Common stock, $0.001 par value; 50,000,000 shares authorized as of December 31, 2018 and 2017; 17,607,928 and 6,000,000 shares issued and outstanding at December 31, 2018 and 2017, respectively |
18 | 6 | ||||||
| Additional paid-in capital | 72,153 | 1,759 | ||||||
| Accumulated deficit | (45,868 | ) | (8,639 | ) | ||||
| Total stockholders’ equity (deficit) | 26,303 | (6,874 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and Stockholders’ equity (deficit) | $ | 28,327 | $ | 13,443 | ||||
| Eton Pharmaceuticals, Inc. | ||||||||
| Condensed Statements of Cash Flows | ||||||||
| (In thousands) | ||||||||
| Year ended December 31, 2018 |
Period from April 27, 2017 (Inception) to December 31, 2017 |
|||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (12,740 | ) | $ | (7,156 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 1,850 | 1,761 | ||||||
| Depreciation and amortization | 63 | 13 | ||||||
| Change in fair value of warrant liability | 2,583 | 41 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other assets | (663 | ) | (170 | ) | ||||
| Accounts payable | 413 | 539 | ||||||
| Accrued liabilities | 349 | 254 | ||||||
| Net cash used in operating activities | (8,145 | ) | (4,718 | ) | ||||
| Cash used in investing activities | ||||||||
| Purchases of property and equipment | (236 | ) | (130 | ) | ||||
| Cash flows from financing activities | ||||||||
| Proceeds from initial public offering, net of underwriting discounts and commissions | 22,803 | — | ||||||
| Payments of initial public offering costs | (843 | ) | — | |||||
| Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs | — | 18,000 | ||||||
| Proceeds from sale of common stock, net of issuance costs | — | 4 | ||||||
| Net cash provided by financing activities | 21,960 | 18,004 | ||||||
| Change in cash and cash equivalents | 13,579 | 13,156 | ||||||
| Cash and cash equivalents at beginning of period | 13,156 | — | ||||||
| Cash and cash equivalents at end of period | $ | 26,735 | $ | 13,156 | ||||
| Supplemental disclosures of cash flow information | ||||||||
| Cash paid for interest | $ | — | $ | — | ||||
| Cash paid for income taxes | $ | — | $ | — | ||||
| Supplemental disclosures of non-cash investing and financing activities: | ||||||||
| Accrued dividends on redeemable convertible preferred stock | $ | 1,048 | $ | 643 | ||||
| Deemed dividends for accretion of redeemable convertible preferred stock issuance costs | $ | 1,694 | $ | 840 | ||||
| Common stock warrant liability issued with redeemable convertible preferred stock financing | $ | — | $ | 479 | ||||
| Purchase of equipment included in accounts payable | $ | 469 | $ | — | ||||
| Beneficial conversion feature on redeemable convertible preferred stock | $ | 21,747 | $ | — | ||||
| Reclassification of common stock warrants from liability to additional paid in capital | $ | 3,103 | $ | — | ||||
Company Contact:
dkrempa@etonpharma.com
847-805-1077
Investor Contact:
Stern Investor Relations, Inc.
Julie.Seidel@sternir.com
212-362-1200
Source: Eton Pharmaceuticals