News Releases
“2019 is off to a great start as we began the year with a very productive first quarter. We added three late-stage product candidates to our pipeline, executed a partnership with
First Quarter Business Milestones:
- Acquired rights to ET-104. In January, Eton acquired marketing rights to ET-104, a patent-pending oral liquid product candidate for 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.
- Acquired rights to two late-stage hospital ready-to-use products. In February, Eton acquired marketing rights from
Sintetica SA for ET-202 and ET-203. Both products are innovative, ready-to-use injectable products administered in the hospital setting. The NDA for ET-202 has been filed with theFDA , and the NDA for ET-203 is expected to be submitted by the third quarter of 2019.
- Established commercialization partnership with
Bausch Health for EM-100. In February, Eton announced an agreement withBausch Health for the commercialization of EM-100, its innovative ophthalmic solution currently under review with theFDA . If approved, EM-100 is expected to be the first and only preservative-free product that isFDA -approved for the treatment of allergic conjunctivitis.
Product Portfolio Update:
Product | Dosage Form | Expecting Filing Year |
ET-202 | Injectable | Submitted |
DS-300 | Injectable | Submitted |
DS-200 | Injectable | Submitted |
EM-100 | Ophthalmic | Submitted |
ET-203 | Injectable | 2019 |
ET-103 | Oral Liquid | 2019 |
ET-104 | Oral Liquid | 2019 |
DS-200 | Injectable | 2020 |
ET-101 | Oral Liquid | 2020 |
ET-102 | Oral Liquid | 2020 |
ET-201 | Injectable | 2020 |
CT-100 | Injectable | TBD |
Eton now has twelve products under various stages of development. Four of these products have been submitted to the
ET-202. During the first quarter, ET-202, Eton’s ready-to-use injectable formulation of phenylephrine for increasing blood pressure in adults with clinically significant hypotension resulting primarily from vasodilation in such settings as septic shock or anesthesia, was assigned a Prescription Drug User Fee Act (PDUFA) date of
Currently,
Upon ET-202’s approval, hospitals will no longer need to rely on compounders for ready-to-use phenylephrine. In addition, ET-202 will align with best practice recommendations from the
Eton believes ET-202 could provide significant benefits to hospitals over the current compounded or manually diluted products, including: reduced risk of dilution or compounding errors, significantly reduced waste due to improved shelf-life, reduced labor costs, and improved sterility assurance.
According to
Eton has begun preparing for commercial launch of ET-202 and, if approved on its PDUFA date, Eton plans to launch the product in the fourth quarter of 2019.
DS-300. DS-300 is an injectable nutrition product administered in the hospital setting. Its NDA was submitted under a Rolling Review and has not been assigned a PDUFA date.
DS-200. DS-200 is an injectable nutrition product administered in the hospital setting. Its NDA was submitted under a Rolling Review and has not been assigned a PDUFA date.
EM-100. EM-100 is Eton’s preservative-free ophthalmic solution for the treatment of allergic conjunctivitis. The product is currently under review with the
First Quarter 2019 Financial Results
Cash Position: As of
Revenue: Revenue was
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 first quarter of 2019 of
Conference Call and Webcast Information:
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.
Condensed Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
For the three months ended March 31, 2019 |
For the three months ended March 31, 2018 |
|||||
Revenues | $ | 500 | $ | — | ||
Operating expenses: | ||||||
Research and development | 6,465 | 1,274 | ||||
General and administrative | 1,589 | 1,690 | ||||
Total operating expenses | 8,054 | 2,964 | ||||
Loss from operations | (7,554 | ) | (2,964 | ) | ||
Other income (expense): | ||||||
Interest and other income, net | 144 | 29 | ||||
Change in fair value of warrant liability | — | (83 | ) | |||
Loss before income tax expense | (7,410 | ) | (3,018 | ) | ||
Income tax expense | — | — | ||||
Net loss | (7,410 | ) | (3,018 | ) | ||
Accrued dividends on redeemable convertible preferred stock | — | (296 | ) | |||
Deemed dividends for accretion of redeemable convertible preferred stock issuance costs | — | (410 | ) | |||
Net loss attributable to common stockholders | $ | (7,410 | ) | $ | (3,724 | ) |
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.42 | ) | $ | (1.05 | ) |
Weighted average number of common shares outstanding, basic and diluted | 17,502 | 3,551 |
Eton Pharmaceuticals, Inc.
Condensed Balance Sheets
(in thousands, except share and per share amounts)
March 31, 2019 | December 31, 2018 | ||||||
(unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 19,584 | $ | 26,735 | |||
Prepaid expenses and other current assets | 1,943 | 767 | |||||
Total current assets | 21,527 | 27,502 | |||||
Property and equipment, net | 1,190 | 773 | |||||
Operating lease right-of-use assets, net | 252 | — | |||||
Other long-term assets, net | 48 | 52 | |||||
Total assets | $ | 23,017 | $ | 28,327 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,208 | $ | 1,421 | |||
Accrued liabilities | 448 | 603 | |||||
Total current liabilities | 3,656 | 2,024 | |||||
Operating lease liabilities, net of current portion | 119 | — | |||||
Total liabilities | 3,775 | 2,024 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity | |||||||
Common stock, $0.001 par value; 50,000,000 shares authorized; 17,627,928 and 17,607,928 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively | 18 | 18 | |||||
Additional paid-in capital | 72,502 | 72,153 | |||||
Accumulated deficit | (53,278 | ) | (45,868 | ) | |||
Total stockholders’ equity | 19,242 | 26,303 | |||||
Total liabilities and stockholders’ equity | $ | 23,017 | $ | 28,327 |
Eton Pharmaceuticals, Inc.
Condensed Statements of Cash Flows
(In thousands)
(Unaudited)
Three months ended March 31, 2019 |
Three months ended March 31, 2018 |
|||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (7,410 | ) | $ | (3,018 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock-based compensation | 345 | 1,050 | ||||||
Depreciation and amortization | 55 | 10 | ||||||
Change in fair value of warrant liability | — | 83 | ||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other assets | (1,187 | ) | (129 | ) | ||||
Accounts payable | 1,736 | 262 | ||||||
Accrued liabilities | (306 | ) | (108 | ) | ||||
Net cash used in operating activities | (6,767 | ) | (1,850 | ) | ||||
Cash used in investing activities | ||||||||
Purchases of property and equipment | (388 | ) | (91 | ) | ||||
Cash flows from financing activities | ||||||||
Proceeds from stock option exercises | 4 | — | ||||||
Net cash provided by financing activities | 4 | — | ||||||
Change in cash and cash equivalents | (7,151 | ) | (1,941) | |||||
Cash and cash equivalents at beginning of period | 26,735 | 13,156 | ||||||
Cash and cash equivalents at end of period | $ | 19,584 | $ | 11,215 | ||||
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 | $ | — | $ | 296 | ||||
Deemed dividends for accretion of redeemable convertible preferred stock issuance costs | $ | — | $ | 410 | ||||
Purchases of equipment included in accounts payable | $ | 51 | $ | — | ||||
Company Contact:
dkrempa@etonpharma.com
847-805-1077
Investor Contact:
Stern Investor Relations, Inc.
Julie.Seidel@sternir.com
212-362-1200
Source: Eton Pharmaceuticals