Iveric Bio Reports Fourth Quarter and Full Year 2022 Operational Highlights and Financial Results
IVERIC bio, Inc. (ISEE) announced the FDA's acceptance of its New Drug Application (NDA) for avacincaptad pegol (ACP) for treating geographic atrophy (GA) associated with age-related macular degeneration (AMD), granting priority review with a PDUFA date of August 19, 2023. A post-hoc analysis from GATHER trials indicated up to a 59% reduction in vision loss at 12 months. The company's commercial launch preparations are accelerating, with a full U.S. sales team expected by April. Financially, IVERIC reported a net loss of $185.2 million for 2022, with R&D expenses increasing to $117.0 million as the company progresses in developing treatments for retinal diseases.
- FDA accepted NDA for ACP with priority review, PDUFA date August 19, 2023.
- Post-hoc analysis shows up to 59% risk reduction in vision loss at 12 months.
- Full U.S. commercial sales team expected to be in place by early April 2023.
- Net loss of $185.2 million for 2022, higher than $114.5 million in 2021.
- R&D expenses increased significantly to $117.0 million for 2022 from $85.1 million in 2021.
- General and administrative expenses rose to $72.9 million in 2022, up from $29.7 million in 2021.
- FDA Accepts Filing of New Drug Application and Grants Priority Review for Avacincaptad Pegol (ACP) for the Treatment of Geographic Atrophy; PDUFA Goal Date is
- Post-hoc Time-to-Event Analysis of ACP GATHER Trials Signals up to
- Commercial Launch Preparations for ACP Continue to Accelerate –
- Conference Call and Webcast Today,
“In 2022, we successfully delivered a banner year with avacincaptad pegol (ACP) achieving a statistically significant reduction in the rate of geographic atrophy (GA) progression at the 12-month pre-specified primary endpoint across two Phase 3 clinical trials,” stated
“We are also excited about the new post-hoc analysis highlighting the potential signal of ACP reducing the rate of vision loss by slowing progression of GA at 12 months of treatment,” stated Pravin U. Dugel, MD, President of
Avacincaptad pegol (ACP): Complement C5 Inhibitor
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In
February 2023 , the Company announced that the FDA accepted for filing the Company’s NDA for ACP for the treatment of GA secondary to AMD. The NDA has been granted priority review with a Prescription Drug User Fee Act (PDUFA) goal date ofAugust 19, 2023 . The Company also announced that, at the time of the FDA’s acceptance letter, the FDA had not identified any potential review issues and the FDA was not currently planning to hold an Advisory Committee meeting for ACP.
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The Company announced today a post-hoc analysis from the ACP GATHER1 and GATHER2 clinical trials signaling up to a
59% reduction in the rate of vision loss for ACP 2 mg compared to sham at 12 months of treatment. Vision loss is defined as a loss of ≥ 15 letters (EDTRS) in Best Corrected Visual Acuity (BCVA) from baseline measured at two consecutive visits up to month 12. This time to event analysis will be presented at theAssociation for Research in Vision and Ophthalmology’s annual meeting fromApril 23-27, 2023 .
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In
November 2022 , the Company announced the FDA granted Breakthrough Therapy designation (BTD) for ACP for the treatment of GA secondary to AMD. To date, ACP is the first and only investigational therapy to receive BTD status for this indication, which was granted based on the 12-month results from GATHER1 and GATHER2.
- The Company intends to pursue further discussions with the FDA about utilizing the GATHER1 and GATHER2 clinical trial data included in the current NDA submission to support treatment of GA associated with earlier stage disease, including in patients with intermediate AMD (iAMD). The Company does not believe it needs to conduct a new clinical trial of ACP in patients with iAMD.
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The Company plans to submit marketing authorization applications (MAAs) to the
European Medicines Agency (EMA) and theUK Medicines and Healthcare Regulatory Agency (MHRA) in 2023, subject to feedback from planned interactions with regulatory authorities inEurope , which the Company expects to have during the first half of 2023. The Company is planning to explore collaboration opportunities for the further development and potential commercialization of ACP outsidethe United States .
- The Company initiated an open-label extension (OLE) study for patients who completed their month 24 visits in the GATHER2 trial, with the aim of providing patients longer-term access to ACP and collecting additional safety data.
- Patient enrollment in STAR, the Company’s Phase 2b screening clinical trial of ACP for the treatment of autosomal recessive Stargardt disease (STGD1), is ongoing.
IC-500: HtrA1 (high temperature requirement A serine peptidase 1 protein) Inhibitor
- The Company is developing IC-500, its HtrA1 inhibitor product candidate, for GA and potentially other age-related retinal diseases. The Company is conducting additional preclinical studies to optimize formulation, dosage and delivery of IC-500 and planning for IND-enabling toxicology studies. The Company expects to submit an investigational new drug application (IND) to the FDA in the first half of 2024.
Gene Therapy Programs in Orphan Inherited Retinal Diseases (IRDs)
- The Company is continuing to advance its minigene programs for Leber’s Congenital Amaurosis type 10 (CEP290), autosomal recessive Stargardt Disease (ABCA4) and Usher’s Syndrome type 2A (USH2A).
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As part of the Company’s previously stated strategy, in
December 2022 the Company entered into an asset purchase agreement withOpus Genetics Inc. (Opus), pursuant to which Opus acquired all of the Company’s rights to IC-100, the Company’s former preclinical product candidate for Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa, and IC-200, the Company’s former preclinical product candidate for BEST1-Related IRDs.
Corporate Update
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In
December 2022 , the Company raised approximately in net proceeds in an underwritten public offering of common stock.$324.3 million
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In late
December 2022 , the Company’s Board of Directors (the Board) elected Pravin U. Dugel, MD, President ofIveric Bio , to the Board, effective as ofJanuary 1, 2023 .Dr. Dugel has been instrumental in helping to shape the Company’s business strategy and in overseeing the development and regulatory strategy for ACP since he joined the Company in 2020.
Fourth Quarter and Year Ended 2022 Financial Results
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As of
December 31, 2022 , the Company had approximately in cash, cash equivalents and available-for-sale securities. The Company estimates that its cash, cash equivalents, available-for-sale securities and committed loan facilities will be sufficient to fund its planned capital expenditure requirements, debt service obligations and operating expenses for at least the next 12 months. This estimate does not include any potential new borrowings under its term loan facility with Hercules Capital and$646.8 million Silicon Valley Bank , beyond the that the Company plans to borrow during 2023 based on its achievement of the performance milestone related to the$25.0 million FDA's acceptance of its NDA for filing.
2022 Q4 Financial Highlights
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R&D Expenses: Research and development expenses were
for the quarter ended$35.8 million December 31, 2022 , compared to for the same period in 2021. For the year ended$25.1 million December 31, 2022 , research and development expenses were compared to$117.0 million for the same period in 2021. Research and development expenses increased primarily due to the continued progress of the Company’s GATHER2 trial, increased manufacturing activities for ACP, and increases in personnel costs associated with additional research and development staffing, including share-based compensation, offset by decreases in costs associated with the Company’s gene therapy programs.$85.1 million
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G&A Expenses: General and administrative expenses were
for the quarter ended$27.1 million December 31, 2022 compared to for the same period in 2021. For the year ended$8.0 million December 31, 2022 , general and administrative expenses were , compared to$72.9 million for the same period in 2021. General and administrative expenses increased year over year primarily due to increases in commercial preparation expenses for ACP and costs associated with additional staffing for commercial preparation, including share-based compensation.$29.7 million
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Net Loss: The Company reported a net loss for the quarter ended
December 31, 2022 , of , or ($59.1 million ) per diluted share, compared to a net loss of$0.47 , or ($33.0 million ) per diluted share, for the same period in 2021. For the year ended$0.29 December 31, 2022 , the Company reported a net loss of or ($185.2 million ) per diluted share, compared to a net loss of$1.53 or ($114.5 million ) for the same period in 2021.$1.12
Conference Call/Webcast Information
About
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 about its expectations regarding the regulatory pathway for and potential approval of ACP for the treatment of GA secondary to AMD, including its plans to submit MAAs to the
Selected Financial Data (unaudited) | ||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||
Three Months Ended |
|
Year Ended |
||||||||||||||
2022 |
|
2021 |
|
2022 |
|
2021 |
||||||||||
Statements of Operations Data: | ||||||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ |
35,841 |
|
$ |
25,096 |
|
$ |
117,012 |
|
$ |
85,068 |
|
||||
General and administrative |
|
27,130 |
|
|
8,001 |
|
|
72,894 |
|
|
29,689 |
|
||||
Total operating expenses |
|
62,971 |
|
|
33,097 |
|
|
189,906 |
|
|
114,757 |
|
||||
Loss from operations |
|
(62,971 |
) |
|
(33,097 |
) |
|
(189,906 |
) |
|
(114,757 |
) |
||||
Interest income, net |
|
1,449 |
|
|
61 |
|
|
2,264 |
|
|
245 |
|
||||
Gain on sale of IC100 & IC200 |
|
2,369 |
|
|
- |
|
|
2,369 |
|
|
- |
|
||||
Other income (expense), net |
|
92 |
|
|
3 |
|
|
62 |
|
|
(10 |
) |
||||
Loss before income tax benefit |
|
(59,061 |
) |
|
(33,033 |
) |
|
(185,211 |
) |
|
(114,522 |
) |
||||
Income tax benefit |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
||||
Net loss | $ |
(59,061 |
) |
$ |
(33,033 |
) |
$ |
(185,211 |
) |
$ |
(114,522 |
) |
||||
Net loss per common share: | ||||||||||||||||
Basic and diluted | $ |
(0.47 |
) |
$ |
(0.29 |
) |
$ |
(1.53 |
) |
$ |
(1.12 |
) |
||||
Weighted average common shares outstanding: | ||||||||||||||||
Basic and diluted |
|
125,367 |
|
|
115,073 |
|
|
121,037 |
|
|
101,866 |
|
||||
(in thousands) | ||||||||||||||||
Balance Sheets Data: | ||||||||||||||||
Cash, cash equivalents and marketable securities | $ |
646,835 |
|
$ |
381,749 |
|
||||||||||
Total assets | $ |
666,823 |
|
$ |
389,358 |
|
||||||||||
Term loan, net | $ |
96,568 |
|
$ |
- |
|
||||||||||
Total liabilities | $ |
132,166 |
|
$ |
28,830 |
|
||||||||||
Additional paid-in capital | $ |
1,399,555 |
|
$ |
1,040,098 |
|
||||||||||
Accumulated deficit | $ |
(864,806 |
) |
$ |
(679,595 |
) |
||||||||||
Total stockholders' equity | $ |
534,657 |
|
$ |
360,528 |
|
ISEE-G
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Investor Contact:
Senior Vice President, Investor Relations
kathy.galante@ivericbio.com
or
Media Contact:
Senior Director,
jeannie.neufeld@ivericbio.com
Source:
FAQ
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