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PARSIPPANY, N.J.--(BUSINESS WIRE)--Nov 3, 2022--
IVERIC bio, Inc. (Nasdaq: ISEE) today announced financial and operating results for the third quarter ended September 30, 2022 and provided a general business update.
“With the positive data from our GATHER2 clinical trial reported in the third quarter reinforcing the positive data from GATHER1, avacincaptad pegol (ACP) became the first and only investigational therapy in geographic atrophy (GA) to achieve its 12-month, prespecified, primary endpoint in two independent pivotal, Phase 3 clinical trials,” stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. “We are excited to announce that we are ahead of schedule in preparing our new drug application (NDA) for ACP for the treatment of GA and we are moving up our submission timeline to the end of this year.”
“As we close out the year and look forward to 2023, we are working diligently to make ACP available to physicians and their patients with GA as expeditiously as possible, subject to regulatory review and approval,” stated Pravin U. Dugel, MD, President of Iveric Bio. “We continue to build our U.S. launch readiness plan and prepare for potential commercialization of ACP. We also continue to explore future development opportunities for ACP in earlier patient populations and to invest in lifecycle initiatives such as sustained release delivery technologies for ACP.”
Avacincaptad pegol(ACP also known as Zimura): Complement C5 Inhibitor
IC-500: HtrA1 (high temperature requirement A serine peptidase 1 protein) Inhibitor
Gene Therapy Programs in Orphan Inherited Retinal Diseases (IRDs)
Non-Dilutive Debt Financing Facility
In July 2022, the Company entered into a term loan debt financing facility with Hercules Capital, Inc. (Hercules Capital) and Silicon Valley Bank (SVB) providing the Company with total borrowing capacity of up to $250 million in non-dilutive debt financing. In July 2022, the Company borrowed $50 million at the close of the facility. The Company believes it has satisfied the first performance milestone under that term loan facility, which would allow it to borrow an additional $50 million. The Company plans to borrow this additional amount in the fourth quarter of 2022.
Third Quarter Financial Results and 2022 Cash Guidance
2022 Q3 Financial Highlights
Conference Call/Webcast 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 November 3, 2022, at 8:00 a.m. Eastern Time. To participate in this conference call, dial 1-888-317-6003 (USA) or 1-412-317-6061 (International), passcode 8170771. A live, listen-only audio webcast of the conference call can be accessed on the Investors 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 1-877-344-7529 (USA Toll Free), passcode 6056402.
About Iveric Bio
Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs. The Company is committed to having a positive impact on patients’ lives by delivering high-quality, safe and effective treatments designed to address debilitating retinal diseases including earlier stages of age-related macular degeneration.
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,” “seek,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. In this press release, the Company’s forward looking statements include statements aboutits expectations regarding the robustness and clinical relevance of the clinical data from its GATHER1 and GATHER2 trials of ACP in GA, its development and regulatory strategy for ACP and its other product candidates, including its plans to submit an NDA to the U.S. Food and Drug Administration and an MAA to the European Medicines Agency for ACP and its plans for evaluating ACP in patients with intermediate AMD, the timing, progress and results of clinical trials and other research and development activities and regulatory submissions, the potential utility of its product candidates and sustained release delivery technologies for ACP, its projected use of cash, cash equivalents, marketable securities and its committed loan facilities and the sufficiency of its cash resources, and statements regarding the Company’s commercial plans and strategy. 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, expectations for regulatory matters, interpretation of clinical trial results by the scientific and medical community, the initiation, progress and success of research and development programs and clinical trials, reliance on clinical trial sites, contract development and manufacturing organizations and other third parties, developments from the Company’s competitors, and the marketplace for the Company’s products, need for and availability of additional financing and negotiation and consummation of business development 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 may 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.
| IVERIC bio, Inc. | ||||||||||||||||
| Selected Financial Data (unaudited) | ||||||||||||||||
| (in thousands, except per share data) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
| Statements of Operations Data: | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 24,967 |
| $ | 17,935 |
| $ | 81,171 |
| $ | 59,972 |
| ||||
| General and administrative |
| 17,545 |
|
| 6,648 |
|
| 45,764 |
|
| 21,688 |
| ||||
| Total operating expenses |
| 42,512 |
|
| 24,583 |
|
| 126,935 |
|
| 81,660 |
| ||||
| Loss from operations |
| (42,512 | ) |
| (24,583 | ) |
| (126,935 | ) |
| (81,660 | ) | ||||
| Interest income, net |
| 200 |
|
| 42 |
|
| 815 |
|
| 184 |
| ||||
| Other expense, net |
| (39 | ) |
| (10 | ) |
| (30 | ) |
| (13 | ) | ||||
| Loss before income tax benefit |
| (42,351 | ) |
| (24,551 | ) |
| (126,150 | ) |
| (81,489 | ) | ||||
| Income tax benefit |
| - |
|
| - |
|
| - |
|
| - |
| ||||
| Net loss | $ | (42,351 | ) | $ | (24,551 | ) | $ | (126,150 | ) | $ | (81,489 | ) | ||||
| Net loss per common share: | ||||||||||||||||
| Basic and diluted | $ | (0.35 | ) | $ | (0.23 | ) | $ | (1.05 | ) | $ | (0.84 | ) | ||||
| Weighted average common shares outstanding: | ||||||||||||||||
| Basic and diluted |
| 120,277 |
|
| 105,217 |
|
| 119,578 |
|
| 97,370 |
|
| September 30, 2022 | December 31, 2021 | |||||||
| (in thousands) | ||||||||
| Balance Sheets Data: | ||||||||
| Cash, cash equivalents and marketable securities | $ | 320,535 |
| $ | 381,749 |
| ||
| Total assets | $ | 331,790 |
| $ | 389,358 |
| ||
| Term loan, net | $ | 47,649 |
| $ | - |
| ||
| Total liabilities | $ | 72,264 |
| $ | 28,830 |
| ||
| Additional paid-in capital | $ | 1,065,545 |
| $ | 1,040,098 |
| ||
| Accumulated deficit | $ | (805,745 | ) | $ | (679,595 | ) | ||
| Total stockholders' equity | $ | 259,526 |
| $ | 360,528 |
|
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View source version on businesswire.com:https://www.businesswire.com/news/home/20221102005742/en/
CONTACT: Investor Contact:
Kathy Galante
Senior Vice President, Investor Relations
kathy.galante@ivericbio.comor
Media Contact:
Jeannie Neufeld
Senior Director, Public Relations & Communications
jeannie.neufeld@ivericbio.com
KEYWORD: UNITED STATES NORTH AMERICA NEW JERSEY
INDUSTRY KEYWORD: RESEARCH CLINICAL TRIALS BIOTECHNOLOGY OTHER HEALTH HEALTH PHARMACEUTICAL OPTICAL OTHER SCIENCE SCIENCE
SOURCE: IVERIC bio, Inc.
Copyright Business Wire 2022.
PUB: 11/03/2022 06:30 AM/DISC: 11/03/2022 06:32 AM
http://www.businesswire.com/news/home/20221102005742/en