Aardvark Therapeutics, Inc.

Phase 2a biomarker study of GRI-0621 for Idiopathic Pulmonary Fibrosis (“IPF”) on track to start before year end 2023; Interim data expected H1 2024 Currently available treatments for IPF are limited with only two approved drugs that come with significant side-effects, limited compliance and no impact on survival1 GRI-0803 systemic lupus erythematosus (“SLE”) program advancing towards completion of IND-enabling studies with IND filing on track for H1 2024 Annual prevalence estimated to be ~161,000 people in the United States affected with definite SLE2 and current treatment options are limited LA JOLLA, CA, Nov. 15, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today reported its financial results for the quarter ended September 30, 2023 and provided a corporate update. “Over the course of this year, we have made fundamental progress on the development and regulatory fronts for our lead program GRI-0621 for IPF as well as GRI-083 for SLE. Importantly, we believe 2024 will be the year of data for GRI Bio,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “We believe we are positioning ourselves for a transformational year and have the potential to unlock significant value for all stakeholders.” Recent Highlights Presented data supporting innovative pipeline of NKT cell modulators for the treatment of high-value inflammatory, fibrotic and autoimmune diseases at the 7th Annual Antifibrotic Drug Development Summit; Presented translational data demonstrating connection between NKT cells and the pathogenesis of IPF at the 2023 Pittsburgh-Ireland International Lung Conference; Entered into a collaboration with the UK consortia, National Institute for Health and Care Research Respiratory Translational Research Collaboration to advance its leading NKT regulation technology to treat inflammatory, fibrotic and autoimmune diseases. Published comprehensive invariant NKT (“iNKT”) cell review in Frontiers in Immunology demonstrating a key role of type 1 iNKT cells in modulating various fibrotic conditions; Participated in conferences and investor-focused events (to watch replays of recent events, click here); and Announced GRI Bio’s entrance into an asset purchase agreement with Aardvark Therapeutics, Inc. (“Aardvark”) pursuant to which Aardvark will acquire certain assets and intellectual property of the Company that pertain to its legacy asset, ADAIR (Abuse Deterrent Amphetamine Immediate Release). GRI-0621: Type 1 invariant NKT (“iNKT”) antagonist in development for the treatment of idiopathic pulmonary fibrosis (IPF). GRI Bio’s lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits the activity of human type 1 iNKT cells. In preliminary trials to date3 and previous trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation and injury in patients. GRI is developing and repurposing GRI-0621 as a once-daily oral capsule for the treatment of IPF with the potential to expand into additional fibrotic indications. The Company plans to leverage the 505(b)(2) regulatory pathway and to launch a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF. Expected GRI-0621 Upcoming Milestones H2 2023: Launch Phase 2a biomarker study H1 2024: Report interim data from Phase 2a biomarker study H2 2024: Report topline results from Phase 2a biomarker study GRI-0803:Novel activator of human type 2 NKT cells in development for the treatment of autoimmune disorders, with an initial focus on SLE. GRI Bio’s second asset in development, GRI-0803, is a novel activator of human type 2 NKT cells. Activation of type 2 NKT leads to a dendritic cell-mediated inhibition of iNKT cells. In the Company’s preclinical studies, type 2 NKT activating molecules, GRI-0803 and GRI-0124, were observed to inhibit both murine and human iNKT cells. Oral administration of these type 2 NKT activating molecules was observed to inhibit lupus nephritis and to significantly improve overall survival. Expected GRI-0803 Upcoming Milestones H1 2024: Complete IND-enabling studies H1 2024: File IND and launch Phase 1a/b Q3 2024: Report Phase 1a SAD topline results Q4 2024: Report Phase 1b MAD topline results Summary of Financial Results for Third Quarter 2023 Net loss was $11.0 million for the nine months ended September 30, 2023. Research and development expenses were $2.2 million and $0.2 million for the nine months ended September 30, 2023 and 2022, respectively. The $2.0 million increase in research and development expenses was primarily due to increases of $1.1 million in expenses related to the development program of GRI-0621, $0.4 million in consulting fees and $0.5 million in personnel expenses. General and administrative expenses were $7.2 million and $0.4 million for the nine months ended September 30, 2023 and 2022, respectively. The $6.8 million increase was primarily related to increased costs for professional fees, including legal, accounting and investment banking fees associated with the previously disclosed merger between the Company (formerly known as Vallon Pharmaceuticals, Inc.) and GRI Bio Operations, Inc. (formerly known as GRI Bio, Inc.) of $4.9 million, personnel expenses of $1.5 million as a result of increased headcount, and increases in consulting, administrative and insurance expenses of $0.4 million as a result of operating as a public company. As of September 30, 2023, the Company had cash and cash equivalents of approximately $3.5 million. About GRI Bio, Inc. GRI Bio is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio’s therapies are designed to target the activity of NKT cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are a functional link between the innate and adaptive immune responses. Type I invariant NKT (“iNKT”) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio’s lead program, GRI-0621, is an inhibitor of iNKT cell activity and is being developed as a novel oral therapeutic for the treatment of idiopathic pulmonary fibrosis, a serious disease with significant unmet need. The Company is also developing a pipeline of novel type 2 NKT agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. These forward-looking statements are based on the Company’s current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the Company’s expectations with respect to development and commercialization of the Company’s product candidates, the timing of initiation or completion of clinical trials and availability of resulting data, the potential benefits and impact of the Company’s clinical trials and product candidates and any implication that the data or results observed in preclinical trials or earlier studies or trials will be indicative of results of later studies or clinical trials, the Company’s beliefs and expectations regarding potential stakeholder value and future financial performance. Actual results may differ from the forward-looking statements expressed by the Company in this press release and consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation: (1) the inability to maintain the listing of the Company’s common stock on Nasdaq; (2) changes in applicable laws or regulations; (3) the inability of the Company to raise financing in the future; (4) the success, cost and timing of the Company’s product development activities; (5) the inability of the Company to obtain and maintain regulatory clearance or approval for its respective products, and any related restrictions and limitations of any cleared or approved product; (6) the inability of the Company to identify, in-license or acquire additional technology; (7) the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently developing; (8) the size and growth potential of the markets for the Company’s products and services, and their respective ability to serve those markets, either alone or in partnership with others; (9) the failure to achieve any milestones or receive any milestone payments under any agreements; (10) inaccuracy in the Company’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (11) the Company’s ability to protect and enforce its intellectual property portfolio, including any newly issued patents; and (12) other risks and uncertainties indicated from time to time in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including the risks and uncertainties described in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K filed with the SEC on February 24, 2023 and subsequently filed reports. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law. Investor Contact: JTC Team, LLC Jenene Thomas (833) 475-8247 GRI@jtcir.com 1 T. M. Maher et al., Global incidence and prevalence of idiopathic pulmonary fibrosis. Respir Res22, 197 (2021) 2 3 I. Maricic et al., Differential Activation of Hepatic Invariant NKT Cell Subsets Plays a Key Role in Progression of Nonalcoholic Steatohepatitis. J Immunol201, 3017-3035 (2018), Tazoral™ for the Treatment of Moderate to Very Severe Plaque Psoriasis Briefing Document, Allergan ( )

Aardvark to acquire global development and commercialization rights to ADAIR and all intellectual property outside of Europe and licensor rights for the EU Aardvark to leverage ADAIR formulation technology for certain follow-on pipeline programs in development GRI to receive modest upfront payment and potential to earn development and commercial milestones up to approximately $80million LA JOLLA, CA, Aug. 23, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that the Company has entered into an asset purchase agreement pursuant to which Aardvark Therapeutics, Inc. (“Aardvark”) will acquire certain assets and intellectual property of the Company that pertain to ADAIR (Abuse Deterrent Amphetamine Immediate Release). Aardvark intends to utilize the ADAIR formation technology for the development of certain follow-on pipeline programs. ADAIR, a legacy asset from the merger with Vallon Pharmaceuticals, Inc. (“Vallon”), is a proprietary abuse-deterrent formulation of immediate release dextroamphetamine for the treatment of attention deficit hyperactivity disorder (“ADHD”) designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high.” Under the terms of the agreement, Aardvark will assume responsibility for and endeavor to develop and commercialize the purchased assets. Exclusive license rights to develop and commercialize ADAIR in Europe and the UK were previously licensed to Medice Arzneimittel Pütter GmbH, a leader in the European ADHD market. GRI Bio will receive a modest up-front payment and the potential to earn milestone payments for achievements in development and commercialization from Aardvark up to approximately $80 million. “This agreement represents a great opportunity for GRI Bio as it allows us to optimize our non-strategic asset that we acquired through our merger with Vallon, while allowing us to maintain our focus on advancing our pipeline of novel assets in development for inflammatory and fibrotic diseases. We believe in the potential of ADAIR and are pleased to have it continue on in its development at Aardvark,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “There continues to be an unmet need for effective products that address the significant and growing problem of stimulant misuse and abuse. ADAIR has demonstrated abuse deterrent properties, but did not surmount the established threshold in its most recent clinical trial to support pursuing an FDA approval. However, we believe there is a real opportunity to utilize Aardvark’s proprietary ARD-101 technology with its established clinical safety pro provide a new formulation to substantially boost the deterrent effect of ADAIR to ultimately gain regulatory approval,” added Tien Lee, M.D., Chief Executive Officer of Aardvark. As the current lead programs utilizing ARD-101 as an orally administered therapeutic agent for Prader-Willi Syndrome will be continuing at Aardvark unabated, Aardvark is considering establishing a separate entity to continue development of ADAIR with ARD-101 to address the urgent need for effective products that will deter stimulant abuse. About Aardvark Therapeutics, Inc. Aardvark Therapeutics is a clinical stage biopharmaceutical company focused on developing novel small molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, inflammation, and other indications. Founded in 2017, the company has now advanced ARD-101 to Phase II clinical trials. Aardvark has multiple other programs in its pipeline. For more information visit . About GRI Bio, Inc. GRI Bio is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio’s therapies are designed to target the activity of NKT cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are a functional link between the innate and adaptive immune responses. Type I invariant NKT (“iNKT”) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio’s lead program, GRI-0621, is an inhibitor of iNKT cell activity and is being developed as a novel oral therapeutic for the treatment of idiopathic pulmonary fibrosis, a serious disease with significant unmet need. The Company is also developing a pipeline of novel type 2 NKT agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. These forward-looking statements are based on the Company’s current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the Company’s expectations with respect to development and commercialization of the Company’s or Aardvark’s product candidates, the initiation or completion of clinical trials, the potential benefits and impact of the Company’s or Aardvark’s product candidates, any estimate or implication as to potential market size or potential revenue, and any reference to potential milestone achievements or related contingent payments, which may or may not be achieved, paid or received in the future. Actual results may differ from the forward-looking statements expressed by the Company or Aardvark in this press release and consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation: (1) the inability to maintain the listing of the Company’s common stock on Nasdaq; (2) changes in applicable laws or regulations; (3) the inability of the Company to raise financing in the future; (4) the success, cost and timing of the Company’s or Aardvark’s product development activities; (5) the inability of the Company or Aardvark to obtain and maintain regulatory clearance or approval for their respective products, and any related restrictions and limitations of any cleared or approved product; (6) the inability of the Company to identify, in-license or acquire additional technology; (7) the inability of the Company or Aardvark to compete with other companies currently marketing or engaged in the development of products and services that the Company or Aardvark are currently developing; (8) the size and growth potential of the markets for the Company’s or Aardvark’s products and services, and their respective ability to serve those markets, either alone or in partnership with others; (9) the failure to achieve any milestones or receive any milestone payments under the asset purchase agreement; (10) inaccuracy in the Company’s or Aardvark’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (11) the Company’s or Aardvark’s ability to protect and enforce its intellectual property portfolio, including any newly issued patents; and (12) other risks and uncertainties indicated from time to time in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including the risks and uncertainties described in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K filed with the SEC on February 24, 2023 and subsequently filed reports. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law. Investor Contact: JTC Team, LLC Jenene Thomas (833) 475-8247 GRI@jtcir.com

SAN DIEGO, Aug. 3, 2023. Aardvark Therapeutics, Inc., a clinical stage biopharmaceutical company, today reported receipt of a Rare Pediatric Disease Designation in Prader-Willi Syndrome (PWS) from the FDA for its lead program ARD-101. This designation means Aardvark is eligible for a Rare Pediatric Disease Priority Review Voucher when ARD-101 receives approval in PWS. The early clinical study results suggest a promising future for a new class of pharmaceuticals that could benefit people with insatiable hunger (hyperphagia) and aggressive food-seeking behaviors, as well as for obesity and metabolic conditions, which are prominent features of the rare genetic condition PWS. Thus far, no drug has been approved by the FDA to treat the hyperphagia associated with PWS. Prader-Willi Syndrome (PWS) PWS is a severe neurodevelopmental disorder with a prevalence of about 1 in 15,000-20,000 births. The disorder is caused by the loss of function of several genes located on chromosome 15. PWS impacts multiple organ systems and is characterized by metabolic, endocrine, and neurological dysfunction. One of the hallmark characteristics of PWS is morbid obesity in early childhood, accompanied by developmental delays and musculoskeletal malformations. Obesity in PWS is driven by hyperphagia and mitigated by strict control of food intake. Strict food control, if anything, exacerbates hyperphagia, anxiety and aggressive food-seeking behavior, which is most stressful for those afflicted as well as their caregivers. About PWS Clinical Study Previously, Aardvark had enrolled 12 subjects in a Phase 2 study of oral ARD-101 in PWS (ClinicalTrials.gov ID NCT05153434) led by Dr. Diane Stafford at Stanford Children's Health and Dr. Shawn McCandless at Colorado Children's Hospital. Based on promising results, Aardvark is enrolling additional subjects and exploring higher drug doses. About ARD-101 Aardvark's lead product, ARD-101, is a first-in-class oral composition that has shown promising activity in reducing hunger cravings in clinical studies and promoting weight loss in pre-clinical studies. ARD-101 is substantially gut-restricted and has minimal systemic exposure. It is postulated that ARD-101 conveys its systemic effects by activating secretion of several gut peptide hormones, including glucagon-like peptides-1 and -2(GLP-1, GLP-2), and cholecystokinin (CCK). Gut CCK is considered a "satiety signal" that acts via the gut-brain axis to control hunger. PWS patients have a normal CCK receptor but their CCK release from gut enteroendocrine I-cells in response to food is impaired, leaving PWS patients with a continuous sense of extreme hunger. Phase I studies demonstrated safety and tolerability in healthy human volunteers. Three Phase II studies have demonstrated an impact on hunger suppression. About Aardvark Therapeutics, Inc. Aardvark Therapeutics is a clinical stage biopharmaceutical company focused on developing novel small molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, inflammation, and other indications. Founded in 2017, the company has now advanced ARD-101 to Phase II clinical trials. Aardvark has multiple other programs in its pipeline. SOURCE Aardvark Therapeutics, Inc. Posted: August 2023