Full Press Release Details
Pharmaceuticals Reports First Quarter 2020 Financial and Operating Results and Provides Business Update
our Phase 2 clinical trial program for ELX-02 in Cystic Fibrosis remains our highest priority
studies advancing in autosomal dominant polycystic kidney disease (ADPKD) and inherited retinal disorders
balance sheet with $44 million in cash and cash equivalents as of March 31, 2020 provides cash runway through the end of 2021
to host webcast and conference call today, Thursday, May 7, 2020, at 4:30 pm ET
MA - May 7, 2020 - Eloxx Pharmaceuticals, Inc., (NASDAQ:
ELOX) a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapeutics to treat
cystic fibrosis and other diseases caused by nonsense mutations limiting production of functional proteins, today reported its
financial results for the three months ended March 31, 2020 and provided a business update.
"Our highest priority is to resume and complete
our Phase 2 proof of concept clinical trial program for ELX-02 in cystic fibrosis, as we believe these data represent a substantial
value inflection point for the Company. As previously announced, these trials have been temporarily paused in response to the
COVID-19 global pandemic in support of global healthcare providers and our shared commitment to ensure patient safety,"
said Dr. Gregory Williams, Chief Executive Officer of Eloxx Pharmaceuticals. "We are working very closely with our clinical
investigators and study sites to ensure that we can resume and complete our Phase 2 trials as rapidly as possible and report top
Cystic Fibrosis Phase 2 Program
ADPKD Kidney Program Update
Ocular Program Update
ELX-02 is an investigational agent not approved by any regulatory
agency for therapeutic use which is currently in Phase 2 clinical trials in cystic fibrosis.
First Quarter 2020 Financial Results
As of March 31, 2020, we had cash, cash
equivalents and marketable securities of $44.0 million, which we expect will be sufficient to fund our operations through the
end of 2021. The cash balance as of March 31, 2020 does not include the loan of $800,000 which we received through the U.S. SBA's
"Paycheck Protection Program."
For the three months ended March 31, 2020,
we incurred a loss of $13.9 million or $0.35 per share, which includes $4.0 million in restructuring charges associated with our
realignment, $2.1 million of which was non-cash stock-based compensation. Net loss also includes $1.9 million in non-cash stock-based
compensation from ongoing operations. For the same period in the prior year, we incurred a net loss of $11.9 million, or $0.33
Our research and development expenses were $4.5 million for
the three months ended March 31, 2020, which includes $0.2 million in non-cash expense related to stock-based compensation. For
the same period in the prior year, R&D expenses were $6.0 million. The quarter to quarter decrease in R&D expenses
of $1.5 million was driven by reduced professional service fees and stock-based compensation, offset by an increase in headcount
and related salaries for a portion of the 2020 period.
Our general and administrative expenses were $5.2 million for
the three months ended March 31, 2020, which includes $1.7 million in non-cash expense related to stock-based compensation. For
the same period in the prior year, G&A expenses were $6.0 million. The decrease was primarily driven by lower non-cash stock-based
compensation and other infrastructure-related costs.
Conference Call and Webcast Information:
Date: Thursday, May 7, 2020
Domestic Dial-in Number: (866) 913-8546
International Dial-in Number: (210) 874-7715
Conference ID: 7798542
Live Webcast: accessible from the Company's website
at www.eloxxpharma.com under Events and Presentations or with this link: https://edge.media-server.com/mmc/p/tgendj2c
Eloxx Pharmaceuticals
Eloxx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical
company developing novel RNA-modulating drug candidates (each designed to be a eukaryotic ribosomal selective glycoside, or ERSG)
that are formulated 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 investigational 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,
currently focusing on cystic fibrosis. ELX-02 is an investigational drug that has not been approved by any global regulatory body.
Eloxx's preclinical candidate pool consists of a library of novel ERSG drug candidates identified based on read-through
potential. Eloxx recently announced a new program focused on rare ocular genetic disorders. Eloxx is headquartered in Waltham,
MA, with operations in Rehovot, Israel and Morristown, NJ. For more information, please visit www.eloxxpharma.com.
Forward-Looking Statements
contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements
can be identified by the words "expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's
current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation
to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking
statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control.
Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact
of a number of factors, including: the development of the Company's read-through technology; the approval of the Company's
patent applications; the Company's ability to successfully defend its intellectual property or obtain 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 Company's ability to obtain applicable regulatory approvals for its current and future
product candidates; the acceptance by the market of the Company's products should they receive regulatory approval; the
timing and success of the Company's preliminary studies, preclinical research, clinical trials, and related regulatory filings;
the ability of the Company to consummate additional financings as needed; the impact of global health concerns, such as the COVID-19
global pandemic, on our ability to continue our clinical and preclinical programs and otherwise operate our business effectively;
as well as those discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities
and Exchange Commission.
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
| March 31, | December 31, | |||||||
| 2020 | 2019 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 25,875 | $ | 22,493 | ||||
| Marketable securities | 18,082 | 33,783 | ||||||
| Restricted cash | 43 | 43 | ||||||
| Prepaid expenses and other current assets | 1,927 | 1,390 | ||||||
| Total current assets | 45,927 | 57,709 | ||||||
| Property and equipment, net | 182 | 201 | ||||||
| Operating lease right-of-use asset | 822 | 924 | ||||||
| Other long-term assets | 110 | 113 | ||||||
| Total assets | $ | 47,041 | $ | 58,947 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,389 | $ | 1,871 | ||||
| Accrued expenses | 3,568 | 4,655 | ||||||
| Current portion of long-term debt | 4,772 | 4,336 | ||||||
| Advances from collaboration partners | 805 | 403 | ||||||
| Current portion of operating lease liability | 507 | 499 | ||||||
| Taxes payable | 43 | 43 | ||||||
| Total current liabilities | 11,084 | 11,807 | ||||||
| Long-term debt | 9,385 | 10,502 | ||||||
| Operating lease liability | 315 | 425 | ||||||
| Total liabilities | 20,784 | 22,734 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.01 par value per share, 5,000,000 shares authorized, no shares issued or outstanding as of March 31, 2020 or December 31, 2019 | - | - | ||||||
| Common stock, $0.01 par value per share, 500,000,000 shares authorized, 40,316,034 and 40,186,469 shares issued and 40,125,454 and 40,030,763 shares outstanding as of March 31, 2020 and December 31, 2019, respectively | 403 | 402 | ||||||
| Common stock in treasury, at cost, 190,580 and 155,706 shares as of March 31, 2020 and December 31, 2019, respectively | (1,819 | ) | (1,703 | ) | ||||
| Additional paid-in capital | 178,573 | 174,515 | ||||||
| Accumulated other comprehensive income | 65 | 18 | ||||||
| Accumulated deficit | (150,965 | ) | (137,019 | ) | ||||
| Total stockholders' equity | 26,257 | 36,213 | ||||||
| Total liabilities and stockholders' equity | $ | 47,041 | $ | 58,947 |
ELOXX PHARMACEUTICALS, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2020 | 2019 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 4,549 | $ | 6,019 | ||||
| General and administrative | 5,224 | 5,958 | ||||||
| Restructuring charges | 3,994 | - | ||||||
| Total operating expenses | 13,767 | 11,977 | ||||||
| Loss from operations | (13,767 | ) | (11,977 | ) | ||||
| Other expense (income), net | 179 | (60 | ) | |||||
| Net loss | $ | (13,946 | ) | $ | (11,917 | ) | ||
| Net loss per share, basic and diluted | $ | (0.35 | ) | $ | (0.33 | ) | ||
| Weighted average number of shares of common stock used in computing net loss per share, basic and diluted | 40,074,275 | 35,910,270 |