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 June 30, 2023 and provided a
corporate update.
“The past quarter was marked by a number of
critical advancements on both the clinical and corporate sides of
our business. We are in the final stages of preparation for the
launch of our Phase 2a biomarker study, which is expected this
year. This study will evaluate our lead program, GRI-0621 for the
treatment of IPF, an Orphan indication in need of innovative
solutions. We are also finalizing our IND-enabling studies for our
SLE program with the goal of filing an IND in the first half of
2024,” commented Marc Hertz, PhD, Chief Executive Officer of GRI
Bio.
“On the corporate side, we closed our merger and
began trading on the Nasdaq under the ticker ‘GRI,’ which we
believe sets the stage for the future success of the Company. We
also refreshed our corporate identity and launched a new corporate
website, which is in line with our mission going forward and
provides all key stakeholders a reliable source to access
information and updates on the Company,” continued Dr. Hertz.
Recent Highlights
- Completed the previously announced
merger with Vallon Pharmaceuticals;
- Launched social channels (Twitter
and LinkedIn) and new website to reiterate the Company’s commitment
to providing much-needed treatment options for inflammatory,
fibrotic and autoimmune diseases;
- Strengthened management team with
CFO appointment bolstered Board of Directors adding leadership and
expertise spanning a combined 75 Years in both public and private
sectors in the life sciences industry;
- Participated in conferences and
investor-focused events. To watch replays of recent events, click
here;
- Announced the issuance of U.S.
Patent No. 11,660,309 entitled, “Prevention and treatment of
inflammatory conditions,” covering methods for the prevention and
treatment of inflammatory conditions; and
- Presented encouraging preclinical
data indicating oral administration of GRI-0803 inhibited Lupus
Nephritis and significantly improved overall survival in animal
models.
GRI-0621: Type
1 invariant NKT (“iNKT”) antagonist in development for the
treatment of idiopathic pulmonary fibrosis (IPF).
IPF is a rare chronic progressive pulmonary
disease with abnormal scarring of the lung blocking the movement of
oxygen into the bloodstream. 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 date1 and
previous trials with the oral formulation, GRI-0621 has been shown
to improve fibrosis in multiple disease models and improve LFTs and
other markers of inflammation and injury in patients.
Key Highlights:
- Orphan
indication with ~40,000 newly diagnosed cases in the United States
annually2
- Currently
available treatments for IPF are limited with only two approved
drugs that come with significant side-effects, limited compliance
and no impact on survival3
- Despite
challenges, total 2022 sales of the two approved drugs in the
United States were ~$4.3 billion combined4
- GRI-0621 is
designed to target upstream in the inflammatory cascade and to
provide potential for greater efficacy
- Established
safety profile as an oral formulation
- iNKT inhibition
demonstrated fibrosis resolution in multiple animal models
- Extensive IP protection with issued
medical use patents and market LOE through 2036
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 systemic lupus
erythematosus (SLE).
SLE, the most common form of lupus, is an
autoimmune disease in which the immune system attacks its own
tissue and organs. 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.
Key Highlights:
- Annual prevalence estimated to be
~161,000 people in the United States affected with definite
SLE5
- Current treatments for SLE are
limited, consisting primarily of immunosuppressive therapies
- GRI-0803 is designed to target
upstream in the inflammatory cascade and to provide potential for
greater efficacy
- Oral administration in a
spontaneous model of lupus nephritis demonstrated significant
inhibition of pro-inflammatory cytokines, including IL-6 and IL-17;
significant inhibition of autoantibodies; and improvement in
overall and proteinuria-free survival
Expected GRI-0803
Upcoming Milestones
- H1 2024: Complete IND-enabling
studies
- H1 2024: File IND
- Q3 2024: Report Phase 1a SAD
topline results
- Q4 2024: Report Phase 1b MAD
topline results
Summary of Financial Results for Second Quarter
2023
Net loss was $8.9 million for the six months
ended June 30, 2023.
Research and development expenses were $0.9
million and $0.1 million for the three months ended June 30, 2023
and 2022, respectively. The $0.8 million increase in research and
development expenses was primarily due to increases of $0.4 million
in expenses related to the development program of GRI-0621, $0.2
million in consulting fees and $0.2 million in personnel
expenses.
General and administrative expenses were $5.1
million and $0.1 million for the three months ended June 30, 2023
and 2022, respectively. The $5.0 million increase was primarily
related to increased costs for professional fees, including legal,
accounting and investment banking fees associated with the Merger,
of $3.8 million, personnel expenses of $0.8 million as a result of
increased headcount, and increases in consulting, administrative
and insurance expenses of $0.3 million as a result of operating as
a public company.
As of June 30, 2023, the Company had cash and
cash equivalents of approximately $4.8 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
initiation or completion of clinical trials, the potential benefits
and impact of the Company’s product candidates, and any estimate or
implication as to potential market size or potential revenue.
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 their 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 its ability to
serve those markets, either alone or in partnership with others;
(9) inaccuracy in the Company’s estimates regarding expenses,
future revenue, capital requirements and needs for and the ability
to obtain additional financing; (10) the Company’s ability to
protect and enforce its intellectual property portfolio, including
any newly issued patents; and (10) 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 Quarterly Report on Form 10-Q filed with
the SEC on May 15, 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. This press
release also contains estimates and other statistical data made by
independent parties and by the Company relating to market size and
growth and other data about its industry. This data involves a
number of assumptions and limitations, and you are cautioned not to
give undue weight to such estimates.
Investor Contact:JTC Team,
LLCJenene Thomas(833) 475-8247GRI@jtcir.com
1 I. Maricic et al., Differential
Activation of Hepatic Invariant NKT Cell Subsets Plays a Key Role
in Progression of Nonalcoholic Steatohepatitis. J
Immunol 201, 3017-3035 (2018), Tazoral™ for
the Treatment of Moderate to Very Severe Plaque Psoriasis Briefing
Document, Allergan
(https://wayback.archive-it.org/7993/20170405104812/https://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4062B1_01_Allergan-Background.pdf)
2 J. Sauleda, B. Núñez, E. Sala, J. B. Soriano, Idiopathic
Pulmonary Fibrosis: Epidemiology, Natural History,
Phenotypes. Med Sci (Basel) 6, (2018) 3
T. M. Maher et al., Global incidence and prevalence of
idiopathic pulmonary fibrosis. Respir
Res 22, 197 (2021)4 Companies’ earnings
reports5 https://www.cdc.gov/lupus/facts/detailed.html
GRI Bio (NASDAQ:GRI)
過去 株価チャート
から 8 2024 まで 9 2024
GRI Bio (NASDAQ:GRI)
過去 株価チャート
から 9 2023 まで 9 2024