Asceniv (intravenous immunoglobulin) / ADMA Biologics - LARVOL DELTA

Product Theater 3 - ADMA Biologics (non-CME): Practical Approaches to Recurrent Respiratory Infections in Patients With Primary Immunodeficiency (ACAAI 2024) - "ASCENIVTM, an IVIG with a unique composition, may play a role in managing these recurrent infections. This discussion will conclude with identifying patients that may benefit from ASCENIVTM and real-world evidence."

Clinical • Immunology • Infectious Disease • Primary Immunodeficiency • Respiratory Diseases

Product Theater 1 - ADMA Biologics : Challenges Associated With Respiratory Infections in Patients With Primary Immunodeficiency: An Expert Discussion & Real-World Experience (ACAAI 2023) - "Description Challenges Associated With Respiratory Infections in Patients With Primary Immunodeficiency: An Expert Discussion & Real-World Experience The expert discussion will focus on the challenges associated with respiratory viral infections and key considerations for managing patients with primary immunodeficiency. ASCENIV™, an approved IVIG with a unique composition, will be introduced, including real-world experience."

Clinical • Real-world • Real-world evidence • Immunology • Infectious Disease • Primary Immunodeficiency • Respiratory Diseases

In-vivo and human evidence for potential efficacy of therapeutic polyclonal RSV neutralizing antibodies for palivizumab-resistant RSV infections. (PubMed, Virology) - "RSV-IG and ribavirin use in immunocompromised patients requires further study."

Journal • Preclinical • Infectious Disease • Inflammation • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections

Case Study: Successful transition to ASCENIV therapy with improved PROMs (CIS 2023) - "How would you describe your stress level? Total score 02/10/2022 3 4 2 3 4 16 03/09/2022 3 4 2 3 5 17 04/05/2022 3 4 2 4 5 18 04/30/2022 3 4 2 4 4 17 06/02/2022 3 4 2 2 4 15 Change to ASCENIV 06/30/2022 3 2 2 3 3 13 07/08/2022 3 2 2 3 3 13 08/06/2022 3 2 2 3 3 13 09/24/2022 3 2 2 3 3 13 10/01/2022 3 2 2 3 3 13 11/01/2022 3 2 2 3 3 13 Conclusions After 6 months of ASCENIV therapy, the patient showed significant improvement in her overall wellbeing and response to therapy."

Clinical • Patient reported outcomes • Chronic Obstructive Pulmonary Disease • CNS Disorders • Endocrine Disorders • Fatigue • Immunology • Infectious Disease • Insomnia • Primary Immunodeficiency • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Sleep Disorder

ASCENIV utilization in a primary immunodeficiency patient with recurrent viral infections. (PubMed, Immunol Med) - "The patient was subsequently managed with immune globulin intravenous, human-slra (ASCENIV™) that contains elevated antibodies against multiple respiratory pathogens. The patient demonstrated significant clinical improvement with a resolution of persistent and debilitating viral respiratory infections and associated sequela."

Journal • Immunology • Infectious Disease • Primary Immunodeficiency • Respiratory Diseases

Product Theater 1 - ADMA Biologics : Challenges Associated with Respiratory Viral Infections in Patients with Primary Immunodeficiency: An Expert Discussion & Real-World Experience (ACAAI 2022) - "Description The expert discussion will focus on the challenges associated with respiratory viral infections and key considerations for managing patients with primary immunodeficiency. ASCENIV™, an approved IVIG with a unique composition will be introduced, including real-world experience."

Clinical • Real-world evidence • Immunology • Infectious Disease • Primary Immunodeficiency

An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD) (clinicaltrials.gov) - P4 | N=12 | Recruiting | Sponsor: ADMA Biologics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Pediatrics • Primary Immunodeficiency

An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD) (clinicaltrials.gov) - P4 | N=12 | Not yet recruiting | Sponsor: ADMA Biologics, Inc. | Initiation date: Mar 2022 ➔ Sep 2022

Trial initiation date • Immunology • Pediatrics • Primary Immunodeficiency

An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD) (clinicaltrials.gov) - P4 | N=12 | Not yet recruiting | Sponsor: ADMA Biologics, Inc. | Initiation date: Oct 2021 ➔ Mar 2022

Trial initiation date • Immunology • Pediatrics • Primary Immunodeficiency

Use of ASCENIV in a Young Male with Immune Abnormalities and Multiviral Induced Respiratory Failure (AAAAI 2022) - "He was given standard immune globulin intravenous (IVIG) followed by ASCENIV, which was associated with rapid improvement of his clinical course. This case demonstrates the benefit of ASCENIV in the setting of acute respiratory failure secondary to chronic RSV bronchiolitis in an young immunocompromised individual."

Immunology • Infectious Disease • Primary Immunodeficiency • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Product Theater 3 - ADMA Biologics (ACAAI 2021) - "He will also introduce ASCENIV, a novel IVIG with a unique composition, which includes a patient case presentation. Supported by ADMA Biologics, Booth #458."

Allergy • Immunology • Infectious Disease • Primary Immunodeficiency

An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD) (clinicaltrials.gov) - P4; N=12; Not yet recruiting; Sponsor: ADMA Biologics, Inc.

Clinical • New P4 trial • Immunology • Pediatrics • Primary Immunodeficiency

First Patient Enrolled in KIDCARES10, Kedrion Biopharma Pediatric Primary Immunodeficiency Study (PRNewswire) - "Kedrion Biopharma...announced that the first patient has been enrolled in the KIDCARES10 (KIg10 in peDiatric subjects: effiCacy, sAfety and phaRmacokinEticS of a 10% IG) clinical trial....Results of KIDCARES10 will be submitted to the U.S. Food and Drug Administration..."

Enrollment status • P3 data • Immunology

ADMA Biologics Receives Unique Permanent J-Code for ASCENIV (GlobeNewswire) - "ADMA Biologics, Inc...announced that the Centers for Medicare and Medicaid Services (CMS) has issued a permanent, product-specific J-code for ASCENIV™. Under the Healthcare Common Procedure Coding System (HCPCS), the J-code (J1554) will become effective April 1, 2021...utilized in the interim for reimbursement purposes."

Reimbursement • Primary Immunodeficiency

"$ADMA ADMA Biologics Receives Unique Permanent J-Code for ASCENIV™ https://t.co/BfAHyw9VVd" (@stock_titan)

"$ADMA ADMA Biologics Receives Unique Temporary C-Code and Pass-Through Payment Status for ASCENIV™ https://t.co/USqP45Gpu7" (@stock_titan)

A New Intravenous Immune Globulin: Novel or Not? (PubMed, Ann Pharmacother) - " The choice of which immune globulin product to select for a patient or formulary is complex. Each product is unique, and differences between products should be taken into consideration, along with cost and availability."

Journal • Immunology • Primary Immunodeficiency

Manufacturing process optimization of ADMA Biologics' intravenous immunoglobulin products, BIVIGAM and ASCENIV™. (PubMed, Immunotherapy) - "This data driven, small-scale approach has led to manufacturing enhancements that have yielded consistent product improvements. The systematic approach to optimizing manufacturing has guided process changes, in-process, procedural and engineering controls that have reduced protein shearing and aggregation, and improved purity resulting in products with lot-to-lot consistency."

Journal • Immunology • Primary Immunodeficiency

ADMA BioCenters receives FDA approval for third plasma collection center (GlobeNewswire) - "ADMA Biologics...announces that the Company’s wholly-owned subsidiary, ADMA BioCenters, has received U.S. Food and Drug Administration ('FDA') approval for its third plasma collection center, located at 166 Ernest W Barrett Parkway, NW, Marietta...Additionally, ADMA BioCenters has received FDA approval for a license supplement to collect whole blood from donors with a rare blood type to produce source plasma that contains high levels of Anti-D antibodies which is the basis for producing Rhoₒ (D) Immune Globulin (Anti-D Ig)."

FDA event • Immunology • Primary Immunodeficiency

"Patented IVIG product Asceniv's antibodies may cross react with SARS-CoV2??? https://t.co/WLJWue8EfQ" (@k_paff)

ADMA Biologics Reports Second Quarter and First Half 2019 Financial Results (GlobeNewswire, ADMA Biologics, Inc.) - “We are pleased with our significant accomplishments reported during the second quarter of 2019, which include two United States Food and Drug Administration (“FDA”) approvals, BIVIGAM® and ASCENIV™, as well as the FDA authorizations of product license transfers for BIVGAM® and Nabi-HB®,” stated Adam Grossman, ADMA’s President and Chief Executive Officer. “During the second quarter, we completed an equity financing of approximately $52 million in gross proceeds, which we expect to use to support the commercial inventory build and product launches for BIVIGAM® and ASCENIV™, expand the manufacturing capacity of our Boca Raton, FL facility, the procurement of raw materials, plasma center expansion, other capital expenditures and for general corporate purposes.” . Obtained FDA approval for ASCENIV™ (formerly RI-002). Received FDA approval for license transfers for BIVIGAM® and Nabi-HB®....Commercial launches and sales of BIVIGAM® and ASCENIV™ in second half of 2019."

Commercial • Launch • Regulatory

ADMA Biologics Reports Full Year 2018 Financial Results (GlobeNewswire, ADMA Biologics, Inc.) - “As part of our compliance enhancement upgrades to our Boca Raton, FL facility, we optimized the intravenous immunoglobulin ('IVIG') manufacturing process for BIVIGAM®. We continue to work with the FDA to finalize our BIVIGAM Prior Approval Supplement ('PAS') for drug substance, with the goal of reintroducing BIVIGAM® to the market this year. We are also working closely with the FDA on the pending application for RI-002’s...The increase in net loss of $22.0 million...increase in cost of product revenue from the manufacture of conformance lots production of RI-002 and BIVIGAM®, which can be used for commercial sales upon FDA approval...

Commercial • Regulatory

ADMA Biologics Enters Into $72.5 Million Loan Facility with Perceptive Advisors (GlobeNewswire, ADMA Biologics, Inc.) - The second loan facility tranche from Perceptive of $27.5 million is predicated on United States Food and Drug Administration (“FDA”) approval of either the BIVIGAM® Prior Approval Supplement or the RI-002 Biologics License Application and is available at ADMA’s election through June 30, 2020, with a minimum draw down of $10 million. “This funding from Perceptive comes at an opportune time for ADMA as we continue to move forward seeking approval for our immunoglobulin products BIVIGAM® and RI-002,” stated Adam Grossman, President and Chief Executive Officer of ADMA.

Financing