News Releases
“We made significant progress in the second quarter expanding and advancing our portfolio of late-stage product candidates, including the acquisition of ET-105, which added an additional high-value, near-term product launch to our portfolio,” said
Recent Business Milestones and Updates:
- Initiated clinical study of ET-104. In
April 2019 , Eton initiated a bioequivalence study for ET-104, one of the company’s patent-pending oral liquid neurology products. Eton anticipates receiving study results in the third quarter of 2019. Pending the successful completion of the study, Eton expects to submit the product’s NDA before year end.
- Acquired U.S. rights to ET-105. In
June 2019 , Eton acquired the U.S marketing rights to ET-105 fromAucta Pharmaceuticals . ET-105 is an innovative patent-pending formulation of lamotrigine to be delivered to patients as an oral liquid for the treatment of various forms of epilepsy. An NDA for ET-105 has been filed with the U.S Food and Drug Administration (FDA ) and was assigned a PDUFA date ofMarch 17, 2020 . Lamotrigine is one of the most widely used anti-epilepsy medications with U.S sales exceeding$700 million annually but is currently onlyFDA -approved in tablet formulations.
- EM-100 Received Complete Response Letter from the
FDA . As previously announced inJuly 2019 , Eton’s partner,Bausch Health , received a Complete Response Letter (CRL) for EM-100. Eton believes that all of the FDA’s questions are addressable and expectsBausch Health to respond to the CRL within the coming months.
- ET-203 New Drug Application was submitted. In late
July 2019 , the NDA for ET-203 was submitted to theFDA . ET-203 is a ready-to-use formulation of a widely used and frequently compounded injectable product. ET-203 is expected to be complementary to Eton’s ET-202, which has been assigned a PDUFA date ofOctober 21, 2019 .
Potential Upcoming Business Milestones:
- ET-104 Clinical Results (Third Quarter 2019)
- ET-103 Clinical Results (Third Quarter 2019)
- ET-202 PDUFA Date (
October 21, 2019 ) - Potential ET-103 NDA Submission (Fourth Quarter 2019)
- Potential ET-104 NDA Submission (Fourth Quarter 2019)
- Potential DS-300 ANDA Submission (Fourth Quarter 2019)
- EM-100 Amendment Submission (Fourth Quarter 2019)
- ET-105 PDUFA Date (
March 17, 2020 ) - Potential EM-100 FDA Response (First Quarter 2020)
Pipeline Update:
Eton currently has four products submitted to the
ET-104: Eton expects bioequivalence study results by
DS-300: DS-300 was previously submitted to the
ET-103: Eton expects bioequivalence study results by
Product (Molecule) | Dosage Form | Category | Expected Submission Timing | Reference Product Market Size |
ET-202 (Phenylephrine) | Injectable | Hospital | Submitted | $50 million + |
ET-105 (Lamotrigine) | Oral Liquid | Neurology | Submitted | $700 million + |
EM-100 (Ketotifen) | Ophthalmic | OTC*** | Submitted | $50 million + |
ET-203 | Injectable | Hospital | Submitted | $90 million + |
ET-104 | Oral Liquid | Neurology | 2019 | $75 million + |
DS-300 | Injectable | Hospital | 2019** | $75 million* + |
ET-103 (Levothyroxine) | Oral Liquid | Endocrinology | 2019 | $2.5 billion + |
DS-100 | Injectable | Hospital | 2020 | $100 million* + |
ET-101 | Oral Liquid | Neurology | 2020 | $800 million + |
ET-102 | Oral Liquid | Neurology | 2020 | $100 million + |
ET-201 | Injectable | Injectable | 2020 | $10 million + |
Note: Reference product market sizes based on IQVIA data unless noted. *Based on management estimates ** Product was previously submitted as an NDA. The FDA has requested resubmission as an ANDA *** Bausch Health acquired U.S Rights and will be responsible for commercialization |
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Second Quarter Financial Results
Revenue: Eton reported no revenue in the second quarter of 2019 and no revenue for the same period in 2018.
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Net Loss: Eton reported a net loss for the second quarter of 2019 of
Cash Position: As of
Conference Call and Webcast Information:
Eton Pharmaceuticals will host a conference call and webcast today at 4:30 p.m. ET (
About Eton Pharmaceuticals
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 | For the six months ended | ||||||||||||||
June 30, 2019 | June 30, 2018 | June 30, 2019 | June 30, 2018 | ||||||||||||
Revenue | $ | — | $ | — | $ | 500 | $ | — | |||||||
Operating expenses: | |||||||||||||||
Research and development | 1,439 | 1,707 | 7,904 | 2,981 | |||||||||||
General and administrative | 1,910 | 990 | 3,499 | 2,680 | |||||||||||
Total operating expenses | 3,349 | 2,697 | 11,403 | 5,661 | |||||||||||
Loss from operations | (3,349 | ) | (2,697 | ) | (10,903 | ) | (5,661 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest and other income, net | 100 | 28 | 244 | 57 | |||||||||||
Change in fair value of warrant liability | — | (413 | ) | — | (496 | ) | |||||||||
Loss before income tax expense | (3,249 | ) | (3,082 | ) | (10,659 | ) | (6,100 | ) | |||||||
Income tax expense | — | — | — | — | |||||||||||
Net loss | (3,249 | ) | (3,082 | ) | (10,659 | ) | (6,100 | ) | |||||||
Accrued dividends on redeemable convertible preferred stock | — | (304 | ) | — | (600 | ) | |||||||||
Deemed dividends for accretion of redeemable convertible preferred stock issuance costs | — | (418 | ) | — | (828 | ) | |||||||||
Net loss attributable to common stockholders | $ | (3,249 | ) | $ | (3,804 | ) | $ | (10,659 | ) | $ | (7,528 | ) | |||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.18 | ) | $ | (0.79 | ) | $ | (0.61 | ) | $ | (1.80 | ) | |||
Weighted average number of common shares outstanding, basic and diluted | 17,733 | 4,786 | 17,618 | 4,172 | |||||||||||
Eton Pharmaceuticals, Inc.
Condensed Balance Sheets
(in thousands, except share and per share amounts)
June 30, 2019 | December 31, 2018 | ||||||
(Unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 14,947 | $ | 26,735 | |||
Prepaid expenses & other current assets | 1,808 | 767 | |||||
Total current assets | 16,755 | 27,502 | |||||
Property and equipment, net | 1,223 | 773 | |||||
Operating lease right-of-use assets, net | 222 | — | |||||
Other long-term assets, net | 44 | 52 | |||||
Total assets | $ | 18,244 | $ | 28,327 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 883 | $ | 1,421 | |||
Accrued liabilities | 576 | 603 | |||||
Total current liabilities | 1,459 | 2,024 | |||||
Operating lease liabilities, net of current portion | 86 | — | |||||
Total liabilities | 1,545 | 2,024 | |||||
Commitments and contingencies (Note 13) | |||||||
Stockholders’ equity | |||||||
Common stock, $0.001 par value; 50,000,000 shares authorized as of June 30, 2019 and December 31, 2018; 17,763,045 and 17,607,928 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 18 | 18 | |||||
Additional paid-in capital | 73,208 | 72,153 | |||||
Accumulated deficit | (56,527 | ) | (45,868 | ) | |||
Total stockholders’ equity | 16,699 | 26,303 | |||||
Total liabilities and stockholders’ equity | $ | 18,244 | $ | 28,327 | |||
Eton Pharmaceuticals, Inc.
Condensed Statements of Cash Flows
(In thousands)
(Unaudited)
Six months ended June 30, 2019 | Six months ended June 30, 2018 |
|||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (10,659 | ) | $ | (6,100 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock-based compensation | 850 | 1,466 | ||||||
Depreciation and amortization | 178 | 23 | ||||||
Change in fair value of warrant liability | — | 496 | ||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other assets | (1,052 | ) | (304 | ) | ||||
Accounts payable | (69 | ) | 329 | |||||
Accrued liabilities | (211 | ) | 12 | |||||
Net cash used in operating activities | (10,963 | ) | (4,078 | ) | ||||
Cash used in investing activities | ||||||||
Purchases of property and equipment | (1,030 | ) | (132 | ) | ||||
Cash flows from financing activities | ||||||||
Proceeds from employee stock purchase plan and stock option exercises | 205 | — | ||||||
Net cash provided by financing activities | 205 | — | ||||||
Change in cash and cash equivalents | (11,788 | ) | (4,210 | ) | ||||
Cash and cash equivalents at beginning of period | 26,735 | 13,156 | ||||||
Cash and cash equivalents at end of period | $ | 14,947 | $ | 8,946 | ||||
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 | $ | — | $ | 600 | ||||
Deemed dividends for accretion of redeemable convertible preferred stock issuance costs | $ | — | $ | 828 | ||||
Company Contact:
dkrempa@etonpharma.com
847-805-1077
Investor Contact:
Stern Investor Relations, Inc.
Julie.Seidel@sternir.com
212-362-1200
Source: Eton Pharmaceuticals