Full Press Release Details
Eloxx Pharmaceuticals Reports Full Year 2017 Financial and Operating Results and Provides Business Update
Company to host webcast and conference call on Tuesday, March 20, 2018 at 8 am ET Management to discuss recent data and
progress on development plans
Waltham, MA. March 19, 2018 Eloxx Pharmaceuticals, Inc.
( Eloxx ), (ELOX) a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapeutics to treat cystic fibrosis, cystinosis and other diseases caused by nonsense mutations limiting production of
functional proteins, today reported its financial results for the twelve months ended December 31, 2017, and provided an update on its clinical development plans.
Given the clinical accomplishments in 2017 for our lead product candidate, ELX-02, we are poised to seek
regulatory clearance to initiate Phase 2 clinical trials in cystic fibrosis and cystinosis this year, said Robert E. Ward, Chairman and CEO of Eloxx Pharmaceuticals. Patients with nonsense mutations have a high burden of disease, and
have few, if any, treatment options available. In cystic fibrosis, therapies to address the needs of patients with nonsense mutations have the potential to lead to the next breakthrough in treating this disease state. We are committed to bringing
forward therapeutic options which have the potential to transform lives.
ELX-02 in Cystic Fibrosis and
ELX-02 is our lead asset and our current development programs are focused on cystic fibrosis and
cystinosis patients with diagnosed nonsense mutations. To advance the program, we have held pre-clinical trial application (CTA) discussions with the Federal Agency for Medicines and Health Products (FAMHP) in
Brussels, Belgium and pre-IND discussions with the U.S. Food & Drug Administration (FDA) for cystic fibrosis and cystinosis, respectively.
Currently, the European Medicines Agency (EMA) has designated ELX-02 as an orphan medicine for the treatment of
mucopolysaccharidosis type I (MPS I), and the FDA has granted orphan drug designation to ELX-02 for the treatment of MPS I and for the treatment of Rett Syndrome.
As part of our clinical program, we have completed a Phase 1 single ascending dose (SAD) study in a total of 60 healthy volunteers at sites in Israel
(ClinicalTrials.gov Identifier: NCT02807961) and Belgium (ClinicalTrials.gov Identifier: NCT03292302). Currently ongoing is the Phase 1 multiple ascending dose (MAD) study in 45 healthy volunteers in Belgium (ClinicalTrials.gov Identifier:
Full Year 2017 Financial Results
2017, we had cash and cash equivalents of $24.0 million, which we expect to fund operations at least through the end of the first quarter of 2019 based on our current operating plans. We received net proceeds of $16.8 million in Q4 2017
related to completing our Series C financing.
We incurred a loss for the year ended December 31, 2017 of $21.2 million. Our research and
development expenses were $16.4 million for the year ended December 31, 2017, compared to $9.0 million for the year ended December 31, 2016, an increase of $7.4 million due to a licensing fee and growth in clinical
Our general and administrative expenses were approximately $4.0 million for the year ended December 31, 2017 compared to
approximately $0.8 million for the year ended December 31, 2016, an increase of approximately $3.2 million. The increase in our general and administrative expenses was primarily related to an increase in our headcount and related
salaries, stock-based compensation, other personnel related costs, and costs related to opening our HQ office in Waltham, MA.
As of September 30, 2017, we reported cash of $13.5 million. For the three months ended December 31, 2017, our use of
cash in operations was $6.3 million. For the three months ended December 31, 2017, our research and development expense totaled $8.4 million, which included $3.4 million in non-cash
expense. For the three months ended December 31, 2017, our general & administrative expense totaled $2.2 million. The Company recorded a net loss of $10.6 million for the three months ended December 31, 2017.
Conference Call Information:
Date: Tuesday, March 20, 2018
Domestic Dial-in Number: (866) 913-8546
International Dial-in Number: (210) 874-7715
Conference ID: 3875349
Live Webcast: accessible
from the Company s website at www.eloxxpharma.com or with this link https://edge.media-server.com/m6/p/w36bkfpa
A replay will be available on the Company s website approximately two hours after the call.
About Eloxx Pharmaceuticals
Eloxx Pharmaceuticals, Inc.
is a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates that are designed to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point
mutations that disrupt protein synthesis from messenger RNA. As a consequence, patients with premature stop codon diseases have reduced or eliminated protein production from the mutation bearing allele accounting for some of the most severe
phenotypes in these genetic diseases. These premature stop codons have been identified in over 1,800 rare and ultra-rare diseases. Read-through therapeutic development is focused on extending mRNA half-life and increasing protein synthesis by
enabling the cytoplasmic ribosome to read through premature stop codons to produce full-length proteins. Eloxx s lead product candidate, ELX-02, is a small molecule drug candidate designed to restore
production of full-length functional proteins. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis and cystinosis. ELX-02 is an
investigational drug that has not been approved by any global regulatory body. Eloxx is headquartered in Waltham, MA, with R&D operations in Rehovot, Israel.
Forward-Looking Statements
Certain statements included in
this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and involve a number of risks and uncertainties. These include statements of management s intentions, belief, plans and
future expectations and, therefore, you are cautioned not to place undue reliance on them. Such forward-looking statements involve risks and uncertainties and actual results could differ materially from any forward-looking statements expressed or
implied herein. The risks and uncertainties that could result in actual results to differ materially from those forward-looking statements express or implied herein include, but are not limited to: the Company s ability to continue as a going
concern; the ability of the Company to consummate additional financings; the development of the Company s technology; the
approval of the Company s patent applications; the Company s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the
Company, if at all; the successful implementation of the Company s research and development programs and collaborations; the success of the Company s license agreements; the acceptance by the market of the Company s products if
approved; the timing and success of the Company s preliminary studies, preclinical research, clinical trials and related regulatory filings; and the continued quotation of the Company s common stock on the over-the-counter securities market, as well as other factors expressed from time to time in the Company s 10-K, 10-Qs and other filings with the U.S. Securities and Exchange Commission (the
SEC ). As a result, this press release should be read in conjunction with the Company s periodic filings with the SEC. The forward-looking statements contained herein are made only as of the date of this press release, and the
Company undertakes no obligation to publicly update or revise such forward-looking statements to reflect subsequent events or circumstances.
ELOXX PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
Amounts in thousands, except share and per share data
| December 31, | ||||||||
| 2017 | 2016 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 24,049 | $ | 2,212 | ||||
| Restricted bank deposit | 102 | 38 | ||||||
| Prepaids and other current assets | 355 | 837 | ||||||
| Total current assets | 24,506 | 3,087 | ||||||
| Property and equipment, net | 278 | 41 | ||||||
| Total assets | 24,784 | 3,128 | ||||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payables | 1,530 | 1,899 | ||||||
| Accrued expenses | 1,893 | 619 | ||||||
| Total current liabilities | 3,423 | 2,518 | ||||||
| Commitments and contingencies (Note 9) | ||||||||
| Stockholders equity: | ||||||||
| Series A, B-1, B-2 and C Preferred Stock, $0.01 par value 5,000,000 and 19,965,708 shares authorized as of December 31, 2017 and 2016, respectively; 0 and 7,638,263 shares issued and outstanding as of December 31, 2017 and 2016, respectively | 76 | |||||||
| Common stock, $0.01 par value 500,000,000 and 29,948,562 shares authorized as of December 31, 2017 and 2016, respectively; 27,527,738 and 4,205,278 shares issued and outstanding as of December 31, 2017 and 2016, respectively | 274 | 42 | ||||||
| Additional paid-in capital | 60,047 | 18,238 | ||||||
| Accumulated deficit | (38,960 | ) | (17,746 | ) | ||||
| Total stockholders equity | 21,361 | 610 | ||||||
| Total liabilities and stockholders equity | $ | 24,784 | $ | 3,128 |
ELOXX PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
Amounts in thousands, except per share and per share data
| Year ended December 31, | ||||||||||||
| 2017 | 2016 | 2015 | ||||||||||
| Operating expenses: | ||||||||||||
| Research and development, net | $ | 16,398 | $ | 8,986 | $ | 5,842 | ||||||
| General and administrative expenses | 3,992 | 854 | 442 | |||||||||
| Total operating expenses | 20,390 | 9,840 | 6,284 | |||||||||
| Loss from operations | (20,390 | ) | (9,840 | ) | (6,284 | ) | ||||||
| Financial and other expenses, net | 824 | 7 | 122 | |||||||||
| Net loss | $ | 21,214 | $ | 9,847 | $ | 6,406 | ||||||
| Basic and diluted net loss per share | $ | 4.75 | $ | 2.60 | $ | 1.67 | ||||||
| Weighted average number of Common Stock used in computing basic and diluted loss per share | 4,976,377 | 4,205,277 | 4,148,389 |