On November 3, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company") an AI-driven innovator of precision antibody immunotherapies, reported it is seeking to divest its contract development and manufacturing organization (iBio CDMO, LLC) in order to complete its transformation into an antibody discovery and development company (Press release, iBioPharma, NOV 3, 2022, View Source [SID1234623099]). Proceeds and cost-savings from the divestiture of the CDMO facility and reduction in operations will be invested in advancing the Company’s lead immuno-oncology assets towards the clinic, as well as the continued development of the RubrYc Discovery Engine, the artificial intelligence ("AI") platform used to create the majority of iBio’s therapeutic candidates, and intended to extend the Company’s cash runway.

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"We currently possess valuable assets in both biomanufacturing and biotech," said Tom Isett, CEO of iBio. "We believe focusing our efforts on drug discovery and development to be the path to greatest value-creation for shareholders, especially given the recent addition of RubrYc Therapeutics’ pipeline and tools to engineer precision-targeting antibodies. Concurrently, given the strong demand for biomanufacturing capacity, we are providing the opportunity for another organization to more fully utilize the advanced bioanalytical and bioprocess capacity resident in our large-scale cGMP biologics production facility located in the growing Southeast Texas ‘Biocorridor’. We are expecting to complete the CDMO divestiture in 2023, while we focus on advancing our lead preclinical program and our expanding pipeline and partnership opportunities."

Following a detailed review of its pipeline and growth opportunities, iBio will focus its resources on the continued development of its lead immuno-oncology assets including, IBIO-101, an immunotherapy for the depletion of regulatory T cells, and two differentiated, antibody candidates emanating from its antibody discovery platform, EGFRvIII and CCR8. In pre-clinical research, each demonstrates specificity for its target and a high degree of cell-killing capability, with potentially reduced off-target effects.

In order to fund further pipeline and platform development, a global life science transaction firm has been engaged to lead the sale of the assets of the CDMO. This includes the 130,000-square-foot cGMP facility, which is configurable for a variety of large-scale bioproduction systems and iBio’s proprietary FastPharming Expression System and GlycaneeringTM Technology. The Company expects it may be able to complete a transaction in 2023, although there is no assurance as to when, or for how much, iBio may be able to sell its CDMO assets.

In conjunction with the divestment, iBio has commenced a comprehensive workforce reduction of approximately 60% of the current Company staffing levels, primarily focused on the workforce located at the cGMP facility in Bryan, Texas. After the conclusion of the workforce reduction, the majority of the Company is expected to operate out of the new Drug Discovery Center in San Diego, CA, which opened in September of this year.

"While parting with members of our ‘WeBio’ team will be incredibly difficult, we do so with the knowledge that demand for their talents in the Texas Biocorridor area is high," commented Michael Jenkins, iBio’s VP, Operations. "On behalf of the CDMO site leadership team, we thank our colleagues who have invested so much in our Bryan/College Station facility – and whose dedication to our mission has helped build the Company and developed iBio’s proprietary FastPharming Expression System and Glycaneering Technology."

The transition to a focused AI-Biotech business is expected to reduce iBio’s monthly burn rate by approximately half, or approximately $2.5-3.0 million per month. Assuming an asset sale at levels comparable with other similar cGMP facilities, the Company believes that cost reductions in conjunction with proceeds from asset sales could provide cash runway into the first half of calendar year 2024.

Considering its announced change in geographic location, iBio will commence a search for a new CEO. It is expected that Mr. Isett will continue as CEO of iBio through this transformation. In order to maintain consistency, William D. (Chip) Clark was appointed by the Board of Directors to assume the role of Chairman.

"On behalf of the Board of Directors, we want to thank Tom for his ongoing service to iBio. Tom’s experience will help us guide the Company through this strategic transformation," said Mr. Clark, Chairman of iBio.

On November 3, 2022 Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported financial results and provided business updates for the third quarter of fiscal year 2022 (Press release, Moderna Therapeutics, NOV 3, 2022, View Source [SID1234623098]).

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"Today’s earnings continue to show strong corporate momentum. With $13.6 billion in product sales through the first three quarters of the year, and advance purchase agreements for anticipated delivery this year now expected to produce around $18 to $19 billion of product sales, we continue to have a strong financial position as we prepare for multiple upcoming global product launches," said Stéphane Bancel, Chief Executive Officer of Moderna. "It has never been clearer that the future of medicine is upon us. As a platform company with scale and resources, Moderna is uniquely positioned to execute on exciting programs in flu, RSV, rare diseases and immuno-oncology, where we have an imminent Phase 2 data read-out. We were also just named a Top Employer by Science for the eighth consecutive year, reflective of the deep commitment of our now more than 3,700 employees globally. There has never been a more promising time for Moderna."

Recent Progress Includes:

Respiratory Vaccines

Received authorization for mRNA-1273.214 booster targeting the BA.1 Omicron subvariant in the United Kingdom, Switzerland, Australia, Canada, European Union and Japan. mRNA-1273.214 induced significantly higher titers than mRNA-1273 against the BA.1 and BA.4/5 Omicron subvariants in a clinical trial conducted before the fall booster season.
mRNA-1273.222 booster, targeting the BA.4/5 Omicron subvariant, is authorized in the United States, European Union, Taiwan and Japan. Phase 2/3 data is expected to be available in the fourth quarter of 2022.
Moderna continues to progress its respiratory vaccine pipeline, including vaccine candidates against influenza, RSV, and combination vaccines. Influenza (mRNA-1010) Phase 3 studies are ongoing. The southern hemisphere immunogenicity study of mRNA-1010 is fully enrolled with approximately 6,000 adult participants, and the data readout is expected in the first quarter of 2023. Initial regulatory feedback supports an accelerated pathway for approval based on this study.
Older adult RSV pivotal Phase 3 trial (mRNA-1345), known as ConquerRSV, is ongoing. Trial has enrolled >35,500 participants. Primary endpoints are safety and vaccine efficacy. The trial data could read out this winter,depending on the number of cases accrued and vaccine effectiveness. Pediatric RSV (mRNA-1345) is in Phase 1 and is now fully enrolled.
Combination COVID + flu (mRNA-1073) Phase 1/2 fully enrolled; combination COVID + flu + RSV (mRNA-1230) has started Phase 1; combination RSV + influenza (mRNA-1045), a new vaccine candidate, has started Phase 1/2 trial.
Latent & Public Health Vaccines:

CMV vaccine (mRNA-1647) pivotal Phase 3 study, known as CMVictory, is ongoing.
Therapeutics

Immuno-oncology

Personalized cancer vaccine (PCV) Phase 2 study evaluating mRNA-4157/V940 in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with high-risk melanoma is fully enrolled, with the primary efficacy analysis expected in the fourth quarter of 2022. As announced on October 12, Merck has exercised its option to jointly develop and commercialize mRNA-4157/V940 pursuant to the terms of its existing Collaboration and License Agreement, and Moderna has received $250 million from Merck in the fourth quarter in connection with the option exercise.
After a portfolio review, AstraZeneca returns rights to the IL-12 program; Moderna is evaluating next steps for the program.
Rare diseases

Phase 1/2 Paramount study of propionic acidemia (PA) candidate (mRNA-3927) isongoing and enrolling additional cohorts. As reported on R&D Day, six patient-years of experience were accrued on drug as of September 8, 2022, with all eligible participants electing to continue on Open Label Extension study. mRNA-3927 has been generally well-tolerated to date and encouraging data has shown a decrease in the number of metabolic decompensation events (MDEs) among participants; initial discussions with regulators are supportive of MDE as a primary endpoint for a pivotal study.
mRNA-3139, for ornithine transcarbamylase (OTC) deficiency, a rare genetic disorder, is in preclinical development.
Moderna now has 48 programs in development across 45 development candidates[1], of which 35 are currently in active clinical trials. The Company’s updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published more than 130 peer reviewed manuscripts.

Third Quarter 2022 Financial Results

Revenue: Total revenue for the third quarter of 2022 was $3.4 billion compared to $5.0 billion in the same period in 2021, mainly due to a decline in sales of the Company’s COVID-19 vaccines. Product sales for the third quarter of 2022 were $3.1 billion, a decrease of 35%, compared to the same period in 2021, primarily driven by lower sales volume due to the timing of market authorizations for our COVID-19 bivalent boosters and the related manufacturing ramp up.
Cost of Sales: Cost of sales was $1.1 billion, or 35% of product sales, for the third quarter of 2022, including third-party royalties of $106 million. Cost of sales, as a percentage of product sales, increased by 20 percentage points, from 15% in the same period in 2021. This includes a charge of $333 million for inventory write-downs related to COVID-19 products that have exceeded or are expected to exceed their approved shelf-lives prior to being used, an expense for unutilized manufacturing capacity of $209 million, and a loss on firm purchase commitments and related cancellation charges of $102 million. These charges are driven by a shift in product demand to our Omicron-targeting COVID-19 bivalent boosters and costs associated with surplus production capacity.
Research and Development Expenses: Research and development expenses for the third quarter of 2022 increased 57% to $820 million, in comparison to the same quarter of 2021. The growth in spending was mainly due to an increase in clinical trial-related expenses, largely driven by increased clinical development activities, particularly with respect to our COVID-19 vaccines, RSV, flu and CMV programs, and increased headcount.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the third quarter of 2022 increased 65% to $278 million, in comparison to the same quarter of 2021. The growth in spending was mainly due to increased headcount and external spend driven by commercial activities and to accelerate the Company’s build-out.
Effective Tax Rate: The effective tax rate was 14% for the third quarter of 2022, compared to 6% for the same period in 2021. The increase in 2022 was primarily due to the benefit recorded in 2021 related to the release of the valuation allowance on the majority of our deferred tax assets.
Net Income: Net income decreased by 69% to $1.0 billion in the third quarter of 2022, compared to the same period in 2021.
Earnings Per Share: Diluted EPS decreased by 67% to $2.53 in the third quarter of 2022, compared to the same period in 2021.
Cash Position: Cash, cash equivalents and investments as of September 30, 2022 and December 31, 2021 were $17.0 billion and $17.6 billion, respectively.
Net Cash Provided By Operating Activities: Net cash provided by operating activities was $3.3 billion for the nine months ended September 30, 2022, compared to $10.3 billion for the same period in 2021. Net cash provided by operating activities decreased in 2022, primarily attributable to revenue recognized from deferred revenue in excess of customer deposits received and increased income tax payments, partially offset by increased product sales and higher collection of receivables.
Cash Used for Purchases of Property and Equipment: Cash used for purchases of property and equipment was $308 million for the nine months ended September 30, 2022, compared to $164 million for the same period in 2021. The increase was primarily driven by the Company’s business expansion of its manufacturing and research facilities.
Cash Used for Repurchases of Common Stock: Cash used for repurchases of common stock was $2.9 billion for the nine months ended September 30, 2022. Moderna did not conduct share repurchases prior to the fourth quarter of 2021. From the end of the third quarter of 2021 to the end of the third quarter of 2022, the Company repurchased 24 million shares, reducing the number of common shares outstanding from 405 million to 387 million, more than offsetting 5 million shares of common stock issued in connection with equity compensation over this period.
2022 Financial Framework

Advance Purchase Agreements (APAs): Revenue from Moderna’s APAs for product sales for anticipated delivery in 2022 are expected to be $18-19 billion, reflecting deferrals of $2-$3 billion to 2023.
Cost of Sales: Cost of sales as a percentage of product sales are now expected to be 26-28% of sales, with the upper end of the range potentially driven by further charges due to product updates.
Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses: Full-year expenses are expected to be approximately $4 billion.
Tax Rate: The Company expects an effective tax rate for the full year in the low- to mid-teen percentage range.
Capital Expenditures: The Company expects capital investments for 2022 of approximately $0.5 billion.
2023 Advanced Purchase Agreements

Confirmed APAs, as well as previously deferred product sales, currently represent $4.5-$5.5 billion in anticipated product sales in 2023. The Company expects additional sales in key markets, including the U.S., E.U., Japan, Middle East, Latin America and Asia Pacific in 2023.
Share Repurchase Program

The $3 billion share repurchase program announced in February 2022 was completed early in the fourth quarter 2022. The Company has commenced repurchases from the additional $3 billion program announced in August 2022.
Corporate Updates

Continued Growth: Moderna had approximately 3,700 employees as of September 30, 2022, compared to approximately 2,400 employees as of September 30, 2021.
Top Employer: Moderna named a Top Employer by Scienceand Science Careers for eighth consecutive year.
R&D Day: On September 8, Moderna held its annual R&D Day to review clinical trial programs across the portfolio, noting early clinical benefits in two rare disease programs, upcoming PCV data and preparation for multiple global product launches.
Executive Committee Appointments and Expansion
On September 6, Jamey Mock was appointed Chief Financial Officer of Moderna, following the retirement of David Meline.
On September 29, Moderna announced that it was expanding its Executive Committee to prepare for new product launches. As part of this expansion, Juan Andres will assume a new role as President, Strategic Partnerships and Enterprise Expansion. Jerh Collins has joined Moderna from Novartis and will succeed Juan Andres as Moderna’s Chief Technical Operations and Quality Officer. These changes will take effect on January 1, 2023.
Key 2022 Investor and Analyst Event Dates

ESG Day: November 10
Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on Thursday, November 3, 2022.

To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.

Telephone: https://register.vevent.com/register/BI50e67285a997429fb4ca40ef36765c8a
Webcast: View Source
The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.

On November 3, 2022 Cimeio Therapeutics, a biotechnology company developing a novel approach to cell therapies, reported the acceptance of two abstracts for the company’s pipeline programs to be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December 2022 in New Orleans (Press release, Cimeio Therapeutics, NOV 3, 2022, View Source;utm_medium=rss&utm_campaign=cimeio-therapeutics-announces-acceptance-of-ash-abstracts-detailing-pipeline [SID1234623097]).

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In addition, the company has strengthened its board of directors with the additions of Luca Santarelli, M.D., and Michael Tomsicek.

ASH abstracts
Cimeio’s SCIP platform (Shielded Cell & Immunotherapy Pairs) uses gene editing tools to insert novel protein variants into hematopoietic stem cells or other types of cells, allowing the cells to maintain their function while making them resistant to paired immunotherapy depletion. Cimeio’s platform has effectively shielded cells from depletion mediated by antibodies, T-cell engagers, ADCs, and CAR-T cells in preclinical studies. The company is advancing its first programs towards clinical development for genetic and malignant hematologic diseases.

The first abstract to be presented at the upcoming ASH (Free ASH Whitepaper) meeting is titled "Function-preserving single amino acid substitutions shield hematopoietic stem and progenitor cells from CD117 targeted immunotherapy in vivo." This describes how CD117-shielded HSPCs could enable higher, longer and/or repetitive antibody dosing, allowing for toxin-free conditioning, post-transplant adjustment of donor chimerism, and targeted treatment of minimal residual disease in CD117+ malignancies.

The second abstract is titled "Engineered Single Amino Acid Substitutions Protect Hematopoietic Stem and Progenitor Cells From CD123 Targeted Immunotherapy." These findings detail how single amino acid substitutions in CD123 introduced to HSPCs by CRISPR/Cas9-mediated HDR enable selective shielding from various immunotherapies, while preserving biophysical and functional properties.

"With the presentation of our first preclinical data we have demonstrated that our shielding technology works in vivo, and across two of our leading programs," said Cimeio CEO Thomas Fuchs. "Our CD117 shield results in no residual binding when paired with our highly potent CD117 antibody. This pair serves as the basis for a powerful combination that could transform HSCT for patients with severe genetic and malignant hematological diseases."

Board appointments
Dr. Santarelli is the founder and CEO of VectivBio, a clinical-stage biopharmaceutical company pioneering novel transformational treatments for severe rare conditions. He has more than 20 years of experience in academic and industrial R&D, having led drug programs in the areas of neuroscience, rare diseases, ophthalmology, metabolic and G.I., spanning the value chain from discovery research to commercialization. Previously, Dr. Santarelli served as Chief Executive Officer and co-founder of Therachon AG, which was acquired by Pfizer Inc. in 2019 for $810 million.

Prior to Therachon, he spent 12 years at Roche, most recently serving as the Senior Vice President and Head of Neuroscience, Ophthalmology and Rare Diseases, as well as Small Molecule Research at Roche in Switzerland. Dr. Santarelli completed his M.D. and Psychiatry Residency at the University of Turin, Italy, and a postdoctoral fellowship at Columbia University, focusing on the molecular mechanisms of psychiatric disorders and adult brain stem cells.

Mr. Tomsicek is the former CFO of CRISPR Therapeutics, a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases. Prior to joining CRISPR, Mr. Tomsicek served as CFO of Abiomed and before that was SVP and CFO at Cubist Pharmaceuticals.

Prior to Cubist, Mr. Tomsicek spent nearly eight years at General Electric Healthcare, as finance manager in global operations, and then as CFO of its ultrasound business. He holds a bachelor of science degree in engineering and a master of business administration, both from the University of Wisconsin.

"We are very pleased to welcome Luca and Mike to the Cimeio Board. They are both seasoned biotech executives who will be instrumental as we grow the company in this next phase," said Alex Mayweg, Ph.D., Chairman of Cimeio and Managing Director at founding investor Versant Ventures.

On November 3, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported a late-breaking abstract relating to its phase II TACTI-002 trial has been accepted for an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2022 (Press release, Immutep, NOV 3, 2022, View Source [SID1234623096]). The oral presentation will include new clinical data for eftilagimod alpha ("efti"), its first-in-class soluble LAG-3 protein, in combination with pembrolizumab in 1st line non-small cell lung cancer (NSCLC) patients. The 37th Annual SITC (Free SITC Whitepaper) meeting will be held in Boston, MA and virtually from 8 to 12 November 2022.

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Details of the presentation are as follows:

As already announced, initial data from the INSIGHT-003 clinical trial treating patients with various solid tumours with triple combination therapy of efti, anti-PD-1 therapy, and chemotherapy, will be presented in a poster presentation at the 37th Annual SITC (Free SITC Whitepaper) meeting. A Trial in Progress poster on the randomised Phase IIb TACTI-003 study of efti in combination with pembrolizumab as 1st line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma will also be presented. Further details on these poster presentations are available here.

Abstracts for all three presentations will be available in a Journal for ImmunoTherapy of Cancer Supplement, which will be published on 7 November 2022 at 8 am EST. The Abstracts will also be subsequently made available on the Investors section of Company’s website under Presentations.

About Eftilagimod Alpha (Efti)

Efti is Immutep’s proprietary soluble LAG-3 clinical stage candidate that is a first-in-class antigen presenting cell (APC) activator for the treatment of cancer, capitalising on LAG-3’s unique characteristics to stimulate both innate and adaptive immunity. Efti binds to and activates antigen presenting cells via MHC II molecules leading to expansion and proliferation of CD8+ (cytotoxic) T cells, CD4+ (helper) T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and HER2–/HR+ metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

About TACTI-002

TACTI-002 (Two ACTive Immunotherapies) is a Phase II clinical trial being conducted in collaboration with Merck & Co., Inc., Rahway, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of Immutep’s eftilagimod alpha with MSD’s KEYTRUDA (pembrolizumab) in up to 189 patients with 2nd line head and neck squamous cell carcinoma (HNSCC) or non-small cell lung cancer (NSCLC) in 1st and 2nd line.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On November 3, 2022 IVERIC bio, Inc. (Nasdaq: ISEE) reported financial and operating results for the third quarter ended September 30, 2022 and provided a general business update (Press release, Ophthotech, NOV 3, 2022, View Source [SID1234623095]).

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"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
•In September 2022, the Company announced that GATHER2, the Company’s second Phase 3 clinical trial of ACP for the treatment of GA, met its pre-specified primary endpoint at 12 months with statistical significance and a favorable safety profile.

•Results from GATHER1, the Company’s first Phase 3 clinical trial of ACP for the treatment of GA, and GATHER2, as well as the Company’s Special Protocol Assessment with the U.S. Food and Drug Administration (FDA), provide the basis for an NDA, which the Company plans to submit to the FDA by the end of this year. The Company is also planning to submit a marketing authorization application (MAA) to the European Medicines Agency in 2023, subject to feedback from planned interactions with regulatory authorities in Europe.

•The GATHER2 topline results for ACP were presented in two oral sessions as part of the Retina Subspecialty Day at the American Academy of Ophthalmology 2022 Annual Meeting on September 30, 2022.

•The Company recently initiated an open-label extension (OLE) trial for patients who completed their month 24 visits in the GATHER2 trial, with the aim of providing patients access to ACP and collecting additional safety data. Patients will be treated with ACP for 18 months or until potential regulatory approval of ACP in the applicable region, whichever is earlier.

•The Company received favorable feedback from the FDA on its development plans for intermediate AMD. The Company is continuing to engage with the FDA regarding its development plans and strategy for this important patient population.

•In July 2022, a post-hoc analysis from the GATHER1 clinical trial was presented at the Annual Meeting of the American Society of Retina Specialists. In the post-hoc analysis, ACP was observed to be associated with a reduction in GA lesion growth compared to sham across all distances from the foveal center point.

•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 plans to conduct additional preclinical studies to optimize formulation, dosage and delivery of IC-500. As a result, the Company does not expect to submit an investigational new drug application for IC-500 mid-next year, as it had previously planned. The Company remains committed to this program and will provide additional information as it becomes available.

Gene Therapy Programs in Orphan Inherited Retinal Diseases (IRDs)
•As the Company focuses its efforts and resources on the development and potential commercialization of ACP, the Company is currently seeking potential collaborators or licensees for the future development and potential commercialization of IC-100, the Company’s product candidate for Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP) and IC-200, the Company’s product candidate for BEST1-Related IRDs.

•The Company is continuing its minigene programs for Leber’s Congenital Amaurosis type 10 (CEP290), autosomal recessive Stargardt Disease (ABCA4) and Usher’s Syndrome (USH2A).

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

•As of September 30, 2022, the Company had $321 million in cash, cash equivalents and available for sale securities, which reflects the impact of its $50 million initial borrowing under its term loan debt financing facility with Hercules and SVB.

•The Company estimates its year-end 2022 cash, cash equivalents and available for sale securities to range between $265 and $275 million. 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 through at least mid-2024. These estimates are based on the Company’s current business plan, including the continuation of its ongoing clinical development programs for ACP in GA and STGD1, including the recently initiated OLE trial, evaluating ACP for intermediate AMD, preparation and submission of an NDA and an MAA for ACP in GA, continuing preparations for potential commercialization of ACP in GA in the United States, pursuing DelSiTech’s silica-based sustained release delivery technology and exploring additional sustained release delivery technologies for ACP, and the advancement of its IC-500 development program as currently planned. These estimates do not include any potential new borrowings under the term loan facility with Hercules and SVB, including the $50 million that the Company plans to borrow in the fourth quarter of this year. Also excluded from these estimates

are any potential approval or sales milestones payable to Archemix Corp. or any potential expenses for actual commercial launch of ACP, such as associated sales force expenses, any additional expenditures related to potentially studying ACP in indications outside of GA, STGD1 and intermediate AMD, or resulting from the potential in-licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue.

2022 Q3 Financial Highlights

•R&D Expenses: Research and development expenses were $25.0 million for the quarter ended September 30, 2022, compared to $17.9 million for the same period in 2021. For the nine months ended September 30, 2022, research and development expenses were $81.2 million compared to $60.0 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, including share-based compensation associated with additional research and development staffing, offset by decreases in costs associated with the Company’s gene therapy programs.

•G&A Expenses: General and administrative expenses were $17.5 million for the quarter ended September 30, 2022, compared to $6.6 million for the same period in 2021. For the nine months ended September 30, 2022, general and administrative expenses were $45.8 million compared to $21.7 million for the same period in 2021. General and administrative expenses increased primarily due to increases in personnel costs, including share-based compensation associated with staffing for commercial preparation.

•Net Loss: The Company reported a net loss for the quarter ended September 30, 2022, of $42.4 million, or ($0.35) per diluted share, compared to a net loss of $24.6 million, or $(0.23) per diluted share, for the same period in 2021. For the nine months ended September 30, 2022, the Company reported a net loss of $126.2 million or ($1.05) per diluted share, compared to a net loss of $81.5 million or ($0.84) for the same period in 2021.

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.