– Conference Call and Webcast Today, May 8, 2019, at 8:00 a.m. ET –
NEW YORK–(BUSINESS WIRE)–IVERIC
bio (Nasdaq: ISEE) today announced financial and operating results
for the first quarter ended March 31, 2019 and provided a business
update.
“2019 is a transformational year for the Company,” stated Glenn P.
Sblendorio, Chief Executive Officer and President of IVERIC bio. “Our
recent re-branding and corporate name change reflects our commitment to
develop gene therapy treatments for patients with orphan inherited
retinal diseases. We believe this is an important time for the Company
as we advance our diversified pipeline with multiple IRD gene therapy
programs, including programs for rhodopsin-mediated autosomal dominant
retinitis pigmentosa, BEST1 related retinal diseases, Leber congenital
amaurosis type 10 (LCA10) and Stargardt disease. We expect to enter into
the clinic with IC-100, our RHO-adRP product candidate, in 2020. Our
therapeutics programs continue to remain on track with clinical data for
Zimura expected in the fourth quarter of 2019 and the second half of
2020. We look forward to the exciting opportunities that lie ahead to
generate value for our shareholders.”
First Quarter/Recent 2019 Highlights
-
As part of the Company’s transformation strategy to focus on
discovering and developing novel gene therapy solutions to treat
orphan inherited retinal diseases (IRDs) with significant unmet
medical needs, the Company rebranded to IVERIC bio, Inc. In
conjunction with the corporate rebrand, the Company began trading on
the Nasdaq Global Select Market under the new ticker symbol “ISEE” on
April 17, 2019. -
A natural history study and IND enabling activities for IC-100 are
ongoing. The Company expects to initiate a Phase 1/2 clinical trial in
rhodopsin mediated adRP in 2020. -
In April 2019, the Company entered into an exclusive global license
agreement with the University of Pennsylvania (Penn) and the
University of Florida Research Foundation for rights to develop and
commercialize novel adeno-associated virus gene therapy product
candidates for the treatment of BEST1 related retinal diseases,
including Best vitelliform macular dystrophy, also known as Best
disease. Natural history studies for BEST1 related retinal diseases
and IND enabling activities for IC-200, the product candidate for this
program, are ongoing. The Company expects to initiate a Phase 1/2
clinical trial with IC-200 in the first half of 2021. -
The Company’s sponsored research programs to evaluate a minigene
strategy for both LCA10, caused by mutations in the CEP290 gene, and
autosomal recessive Stargardt disease, caused by mutations in the
ABCA4 gene, are ongoing. The Company expects to receive research
results for the LCA10 program during this year and expects to receive
research results for the Stargardt minigene ABCA4 program during 2020. -
Initial top-line data for the Company’s ongoing Phase 2b clinical
trial of Zimura® (avacincaptad pegol sodium), which is a C5 complement
inhibitor, for the treatment of geographic atrophy secondary to dry
age-related macular degeneration remains on track for data to be
available in the fourth quarter of 2019. In February 2019, the Company
completed patient enrollment in its Phase 2b clinical trial assessing
the efficacy and safety of Zimura monotherapy in patients with
autosomal recessive Stargardt disease. Initial top-line data is
expected to be available in the second half of 2020. -
Effective January 1, 2019, Calvin W. Roberts, M.D., Senior Vice
President and Chief Medical Officer, Eye Care at Bausch Health
Companies and Clinical Professor of Ophthalmology at Weill Medical
College of Cornell University, was elected to IVERIC bio’s Board of
Directors.
2019 Operational Update
As of March 31, 2019, the Company had $116.6 million in cash and cash
equivalents. The Company estimates its year end 2019 cash and cash
equivalents will range between $80 million and $85 million based on its
current 2019 business plan, including the continued preclinical
development of IC-100 and IC-200, the continuation of its ongoing
collaborative gene therapy sponsored research programs, the continued
clinical development of Zimura and the continued preclinical development
of its HtrA1 inhibitor program. This estimate does not reflect any
expenditures resulting from additional sponsored research agreements the
Company may enter into or the potential in-licensing or acquisition of
additional product candidates or technologies or any associated
development that the Company may pursue.
2019 Financial Highlights
-
R&D Expenses: Research and development expenses were $7.7
million for the quarter ended March 31, 2019, unchanged from the same
period in 2018 as increases in costs associated with the Company’s
gene therapy programs were offset by decreases in costs associated
with the Company’s Zimura programs. -
G&A Expenses: General and administrative expenses were $5.5
million for the quarter ended March 31, 2019, compared to $5.6 million
for the same period in 2018. General and administrative expenses
decreased primarily due to decreases in costs to support the Company’s
operations and infrastructure. -
Net Income: The Company reported a net loss for the quarter
ended March 31, 2019 of $12.5 million, or ($0.30) per diluted share,
compared to net loss of $13.1 million, or ($0.36) per diluted share,
for the same period in 2018.
Conference Call/Web Cast Information
IVERIC bio will host a conference call/webcast to discuss the Company’s
financial and operating results and provide a business update. The call
is scheduled for May 8, 2019 at 8:00 a.m. Eastern Time. To participate
in this conference call, dial 888-224-1005 (USA) or 323-794-2551
(International), passcode 9765307. A live, listen-only audio webcast of
the conference call can be accessed on the Investor Relations section of
the IVERIC bio website at: www.ivericbio.com.
A replay will be available approximately two hours following the live
call for two weeks. The replay number is 888-203-1112 (USA Toll Free),
passcode 9765307.
About IVERIC bio
IVERIC bio is a biotechnology company with a focus on the discovery and
development of novel gene therapy solutions to treat orphan inherited
retinal diseases with unmet medical needs. Vision is Our Mission. For
more information on the Company’s gene therapy and other programs,
please visit www.ivericbio.com.
Forward-looking Statements
Any statements in this press release about the Company’s future
expectations, plans and prospects constitute forward-looking statements
for purposes of the safe harbor provisions under the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include any
statements about the Company’s strategy, future operations and future
expectations and plans and prospects for the Company, and any other
statements containing the words “anticipate,” “believe,” “estimate,”
“expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,”
“project,” “target,” “potential,” “will,” “would,” “could,” “should,”
“continue,” and similar expressions. In this press release, the
Company’s forward looking statements include statements about the
implementation of its strategic plan, including its transition to a gene
therapy focused company, the projected use of cash and cash balances,
the timing, progress and results of clinical trials and other research
and development activities, the potential utility of its product
candidates, and the potential for its business development strategy,
including any potential in-license or acquisition opportunities. Such
forward-looking statements involve substantial risks and uncertainties
that could cause the Company’s development programs, future results,
performance or achievements to differ significantly from those expressed
or implied by the forward-looking statements. Such risks and
uncertainties include, among others, those related to the initiation and
the conduct and design of research programs and clinical trials,
availability of data from these programs, reliance on university
collaborators and other third parties, expectations for regulatory
matters, need for additional financing and negotiation and consummation
of in-license and/or acquisition transactions and other factors
discussed in the “Risk Factors” section contained in the quarterly and
annual reports that the Company files with the Securities and Exchange
Commission. Any forward-looking statements represent the Company’s views
only as of the date of this press release. The Company anticipates that
subsequent events and developments will cause its views to change. While
the Company may elect to update these forward-looking statements at some
point in the future, the Company specifically disclaims any obligation
to do so except as required by law.
ISEE-G
| IVERIC bio | ||||||||
| Selected Financial Data (unaudited) | ||||||||
| (in thousands, except per share data) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2019 | 2018 | |||||||
| Statements of Operations Data: | ||||||||
| Operating expenses: | ||||||||
| Research and development | $ 7,685 | $ 7,686 | ||||||
| General and administrative | 5,481 | 5,645 | ||||||
| Total operating expenses | 13,166 | 13,331 | ||||||
| Loss from operations | (13,166) | (13,331) | ||||||
| Interest income | 670 | 473 | ||||||
| Other expense | – | (16) | ||||||
| Loss before income tax provision | (12,496) | (12,874) | ||||||
| Income tax provision | 5 | 199 | ||||||
| Net loss | $ (12,501) | $ (13,073) | ||||||
| Net loss per common share: | ||||||||
| Basic and diluted | $ (0.30) | $ (0.36) | ||||||
| Weighted average common shares outstanding: | ||||||||
| Basic and diluted | 41,427 | 36,153 | ||||||
| March 31, 2019 | December 31, 2018 | |||||||
| (in thousands) | ||||||||
| Balance Sheets Data: | ||||||||
| Cash and cash equivalents | $ 116,639 | $ 131,201 | ||||||
| Total assets | 124,096 | 137,165 | ||||||
| Total liabilities | 10,127 | 13,206 | ||||||
| Additional paid-in capital | 548,096 | 545,585 | ||||||
| Accumulated deficit | (434,168) | (421,667) | ||||||
| Total stockholders’ equity | $ 113,969 | $ 123,959 | ||||||
Contacts
Investor Contact:
IVERIC bio
Kathy Galante, 212-845-8231
Vice
President, Investor Relations and Corporate Communications
kathy.galante@ivericbio.com
or
Media
Contact:
SmithSolve
Alex Van Rees, 973-442-1555 ext. 111
alex.vanrees@smithsolve.com