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 fiscal year ended December 31, 2023 and provided a
corporate update.
"Over the past several months we've achieved
significant regulatory and clinical milestones while adding $5.5
million to the balance sheet, paving the way for an exciting 2024
marked by key data readouts. Our Phase 2a biomarker study for
GRI-0621 in IPF is gaining momentum and with interim and topline
data expected this year, we believe we have the potential to unlock
substantial value for all stakeholders,” commented Marc Hertz, PhD,
Chief Executive Officer of GRI Bio.
Recent Highlights
- Received notice of allowance for
Canadian patent covering proprietary NKT cell modulators;
- Received authorization of the
Company’s Clinical Trial Application (CTA) by the United Kingdom
(UK) Medicines and Healthcare Products Regulatory Agency to
initiate a Phase 2a biomarker study evaluating GRI-0621 for the
treatment of IPF in the UK;
- Closed a public offering with
participation from healthcare focused institutional investors for
aggregate gross proceeds of $5.5 million;
- Commenced screening patients for
enrollment in Phase 2a biomarker study evaluating the Company’s
lead program GRI-0621 for the treatment of IPF;
- Received U.S. Food and Drug
Administration clearance for the Company’s IND application for
GRI-0621 for the treatment of IPF;
- Presented translational data
demonstrating connection between NKT cells and the pathogenesis of
IPF at the 2023 Pittsburgh-Ireland International Lung Conference
and data at the 7th Annual Antifibrotic Drug Development
Summit;
- Entered into a key collaboration
with the UK Consortia, National Institute for Health and Care
Research Respiratory Translational Research Collaboration to
advance the translational work in IPF patients and prioritize
recruitment for the Phase 2a biomarker study; and
- Announced publication of
comprehensive type 1 invariant NKT (iNKT) cell review in Frontiers
in Immunology demonstrating a key role of iNKT cells in modulating
various fibrotic conditions.
GRI-0621: Type 1 invariant NKT (iNKT) antagonist in
development for the treatment of IPF.
IPF is a rare chronic progressive pulmonary
disease with abnormal scarring of the lung blocking the movement of
oxygen into the bloodstream. 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 Bio’s lead program, GRI-0621, is a small
molecule RAR-βɣ dual agonist that inhibits the activity of human
iNKT cells. In preliminary trials to date 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.
The Company plans to leverage the 505(b)(2)
regulatory pathway and has launched a Phase 2a biomarker study
evaluating GRI-0621 for the treatment of IPF. For more information
about the Phase 2a study, please visit clinicaltrials.gov and
reference identifier NCT06331624.
Expected GRI-0621 Upcoming
Milestones
- 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.
SLE is an autoimmune disease in which the immune
system attacks its own tissue and organs. SLE is the most common
form of lupus. Current treatments are limited, consisting primarily
of immunosuppressive therapies.
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 single
ascending dose (SAD) study topline results
- Q4 2024: Report Phase 1b multiple
ascending dose (MAD) study topline results
Summary of Financial Results for Fiscal
Year 2023
Net loss was $13.0 million for the year ended
December 31, 2023.
Research and development expenses were $3.2
million and $0.2 million for the years ended December 31, 2023 and
2022, respectively. The $3.0 million increase in research and
development expenses was primarily due to increases of $1.9 million
in expenses related to the development program of GRI-0621, $0.4
million in personnel expenses, $0.6 million in consulting fees, and
$0.1 million in intellectual property expenses.
General and administrative expenses were $8.2
million and $2.0 million for the years ended December 31, 2023 and
2022, respectively. The $6.2 million increase was primarily due to
an increase of $4.2 million in legal, accounting and other 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.) as well as fees
associated with operating as a public company, an increase of $1.6
million in personnel costs, an increase of $0.3 million in
insurance expense, and an increase of $0.2 million in consulting
and other general and administrative expenses.
As of December 31, 2023, the Company had cash
and cash equivalents of approximately $1.8 million. Subsequent to
year end, in February 2024 the Company closed a public offering
with participation from healthcare focused institutional investors
for aggregate gross proceeds of $5.5 million. Based on the
Company’s current operating plan, the Company believes that its
existing cash and cash equivalents will be sufficient to fund its
operating expenses and capital expenditure requirements into the
third quarter of 2024
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. 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
IPF, a serious disease with significant unmet need. The Company is
also developing a pipeline of novel type 2 NKT agonists for the
treatment of SLE. 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, the
Company’s beliefs about the timing and outcome of regulatory
approvals and potential regulatory approval pathways, the Company’s
expected milestones for 2024, and the Company’s beliefs and
expectations regarding the sufficiency of its existing cash and
cash equivalents to fund its operating expenses and capital
expenditure requirements. 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 and to comply with applicable
listing requirements; (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 March 28, 2024 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, LLCJenene
Thomas(833) 475-8247GRI@jtcir.com
1 T. M. Maher et al., Global incidence and prevalence of
idiopathic pulmonary fibrosis. Respir Res 22, 197
(2021)
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