Gri Bio Inc.
08/14/2026 | Press release | Distributed by Public on 08/14/2026 05:45
Quarterly Report for Quarter Ending June 30, 2026 (Form 10-Q)
Management's Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q (the Quarterly Report), the audited financial statements and notes thereto, as well as management's discussion and analysis of financial condition and results of operations included in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission (the SEC) on January 30, 2026 (the Annual Report). Some of the information contained in this discussion and analysis, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), that involve risks and uncertainties. As a result of many factors, including those factors set out under the section entitled "Risk Factors" included in the Annual Report, our actual results could differ materially from the results described in or implied by these forward-looking statements.
Overview
We are a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing innovative therapies that target serious diseases associated with dysregulated immune responses leading to inflammatory, fibrotic and autoimmune disorders. Our goal is to be an industry leader in developing therapies to treat these diseases and to improve the lives of patients suffering from such diseases.
Our product candidate, GRI-0621, which received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) on June 18, 2026 for the treatment of IPF, is an oral inhibitor of type 1 iNKT cells. GRI-0621 is also an oral formulation of tazarotene, a synthetic retinoid acid receptor-beta and gamma selective agonist, that is approved in the United States for topical treatment of psoriasis and acne. While there are no approved oral formulations of tazarotene, as of June 30, 2026, it has been evaluated in over 1,700 patients as an oral product for up to 52-weeks. We are developing GRI-0621 for the treatment of severe fibrotic lung diseases such as IPF, a life-threatening progressive fibrotic disease of the lung that affects approximately 140,000 people in the United States, with up to 40,000 new cases per year in the United States. Some estimate that IPF affects 3 million globally. While there are currently two approved therapies for the treatment of lung fibrosis, neither has been associated with improvements in overall survival, and both therapies have been associated with significant side effects leading to poor therapeutic adherence. In preliminary and topline data from our trials to date with GRI-0621, and earlier trials with oral tazarotene, we have observed GRI-0621 to be well-tolerated and to inhibit iNKT cell activity in subjects. We and others have shown that activated iNKT are upregulated in IPF, primary sclerosing cholangitis, metabolic dysfunction-associated steatohepatitis, alcoholic liver disease, SLE, MS, ulcerative colitis patients as well as other indications. In these patients activated iNKT cells are correlated with more severe disease.
We most recently evaluated GRI-0621 in a randomized, double-blind, multi-center, 2-arm Phase 2a clinical trial for the treatment of patients diagnosed with IPF. The primary endpoint for this Phase 2a trial was safety and tolerability of oral GRI-0621, administered as a single daily dose, as assessed by clinical labs, vital signs and adverse events after 12 weeks of treatment. Secondary endpoints were baseline changes in serum biomarkers, differentially expressed genes measured by ribonucleic acid sequencing (RNAseq), T cell receptor sequencing (TCRseq), and flow cytometry in PBMC samples collected at week six and week 12; an assessment of the PK of GRI-0621 at the week 12 visit of treatment (steady state); and a determination of the pharmacodynamic activity of oral GRI-0621 as measured by inhibition of immune cell activation in blood after six weeks and 12 weeks, and from BAL fluid after 12 weeks of treatment. Concurrently, a sub-study examined the number and activity of immune cells in BAL fluid in eight subjects (across various centers). Additional exploratory endpoints for the trial included assessment of the effect of GRI-0621 on pulmonary function at baseline and after six weeks and 12 weeks of treatment. 35 patients were enrolled in the trial and randomly assigned to a placebo arm and a GRI-0621 treatment arm, of which 19 patients completed treatment in the treatment arm and nine patients completed treatment in the placebo arm. Based on topline results available to date, the clinical trial met its primary endpoint and the secondary endpoints measured to date (as described below). Continued analyses of exploratory endpoints, including RNAseq, TCRseq, and the pharmacodynamic activity of GRI-0621, remain consistent with and supportive of previously reported findings. We have filed additional patent applications based, in part, on these data.
No treatment related serious adverse events were reported for GRI-0621-treated subjects and adverse events were grade 2 (17%) or grade 3 (4%), with dry skin, dry lips, muscle and joint pain as the most common adverse events reported. There were no increases in cough (0% in the GRI-0621-treated arm compared to 25% in the placebo arm) or gastrointestinal disorders reported in the GRI-0621-treated arm compared to the placebo arm (diarrhea reported in 13% versus 33%, respectively). 80% of the subjects enrolled were
taking background pirfenidone or nintedanib. No changes in liver enzymes, triglycerides or cholesterol were observed over 12 weeks in patients treated with GRI-0621 and standard of care.
Changes from baseline of serum biomarkers of type I, III and VI collagen in GRI-0621-treated subjects were suggestive of an anti-fibrotic effect, with decreases in biomarkers of fibrosis formation and increases in biomarkers of fibrosis resolution, including crosslinked type III collagen, observed after 12 weeks of treatment with GRI-0621. Changes from baseline in type IV collagen were suggestive of initiation of an alveolar basement membrane repair mechanism, an important step in repair of injured lung tissue. Reductions in neutrophil and macrophage activity (immune cell biomarkers upregulated in IPF and associated with disease progression) and downregulation of genes associated with fibrosis, disease progression and mortality were also observed in patients treated with GRI-0621 and standard of care.
Placebo-adjusted changes from baseline in FVC were observed to increase by 99 ml in the GRI-0621-treated arm and by 139 ml in the subset taking both GRI-0621 and standard of care compared to placebo plus standard of care. Breathing tests used to measure FVC are subject to large visit-to-visit variability and are dependent on the patient's effort, often resulting in data outliers. To minimize the impact of outliers in this FVC dataset, a post hoc data sensitivity analysis was performed. The results of this 1-per-tail Winsorized analysis demonstrated an increase in placebo-adjusted change from baseline in FVC of 65 ml in the GRI-0621-treated arm and an increase of 89 ml in the subset taking both GRI-0621 and standard of care. Overall, 95% more GRI-0621 treated subjects experienced an increase in FVC at 12 weeks compared to placebo (39% vs 20% placebo) and 60% fewer subjects experienced a 10% or greater decline in FVC at 12 weeks compared to the placebo-treated arm (8% vs 20% placebo). GRI-0621-treated subjects also demonstrated increased TCR expression after 12 weeks of treatment compared with baseline or placebo-treated subjects receiving standard of care, suggestive of iNKT inactivation following GRI-0621 treatment. T cell subsets demonstrated increased type 1-associated cytokines (IFN-γ) and reduced type 2 (IL-4 and IL-13) and type 3-associated cytokines (IL-17A and IL-22) in both BAL and PBMC samples. Similarly, TGF-β was observed to be reduced after 12 weeks of GRI-0621 treatment in T cell subsets (e.g. Treg and Treg-like), B cells, monocytes, macrophages and neutrophils in BAL and PBMC samples compared to baseline or placebo-treated subjects receiving standard of care. GRI-0621 treatment also improved expression of genes associated with lung injury, fibroblast differentiation, extracellular matrix deposition, basement membrane repair, and type II alveolar epithelial cell-to-type I alveolar epithelial cell transition. The RNAseq data is supportive of and consistent with earlier reported serum biomarker and flow cytometry data.
Results from this Phase 2a trial are being used to determine safety sample size, clinically relevant endpoints and clinical trial duration in communication with the FDA in designing future trials. The Company recently requested a Type C meeting to discuss clinical study plans for the GRI-0621 IPF program with the FDA and received written feedback from the agency in response. Equipped with the FDA's feedback, the Company is evaluating its clinical development strategy for GRI-0621 and intends to request another meeting with the FDA to obtain the FDA's views on a proposed Phase 2b/3 adaptive trial design. There can be no assurance that the FDA will agree to any such proposed trial design or that the Company will be able to obtain the substantial additional capital or resources necessary to conduct additional clinical studies for GRI-0621.
On June 18, 2026, the FDA granted Orphan Drug Designation to GRI-0621 for the treatment of IPF. Orphan Drug Designation is granted to therapies intended to treat rare diseases affecting fewer than 200,000 people in the United States and provides important development and commercialization benefits, including potential eligibility for seven years of U.S. market exclusivity upon approval, potential tax credits related to qualified clinical development expenses, and waiver of the FDA application fee.
Our product candidate portfolio also includes GRI-0803 and a proprietary library of 500+ compounds. GRI-0803, the lead molecule selected from the library, is a novel oral agonist of type 2 diverse Natural Killer T cells and would be developed for the treatment of autoimmune disorders, with much of our preclinical work in SLE or lupus and MS. In lupus, the immune system mistakenly attacks its own healthy tissues, especially joints and skin, but can affect almost every organ and tissue of the body. The condition can be fatal and often causes debilitating bouts of fatigue and pain that prevent nearly half of adult patients from working. Lupus affects between 160,000 - 200,000 patients in the United States, with around 80,000 - 100,000 patients in the United States suffering from kidney nephritis, one of the most serious manifestations of SLE, typically within five years of diagnosis. There is no cure for lupus, but medical interventions and lifestyle changes can help control it. SLE treatment consists primarily of immunosuppressive drugs that inhibit the activity of the immune system. Only two drugs have been approved for lupus in the past 50 years, and new treatment options are sorely needed. In order to focus our resources on our GRI-0621 program, we previously limited our development of GRI-0803 pending additional funding. We intend to complete IND-enabling studies and file an IND application to evaluate GRI-0803
in a Phase 1a and 1b trial in healthy volunteers in the first half of 2027. We expect to continue to evaluate indications to select the best fit for further development of the program, but our initial focus would be on lupus.
Recent Developments
Reverse Stock Splits
On January 15, 2026, our stockholders approved the January 2026 Reverse Stock Split within a range of not less than one-for-two and not more than one-for-thirty, and our Board of Directors subsequently approved the January 2026 Reverse Stock Split at the ratio of one-for-twenty-eight. Following these approvals, we filed an amendment to our Amended and Restated Certificate of Incorporation, as amended, with the Secretary of State of the State of Delaware to effect the January 2026 Reverse Stock Split as of 4:01 p.m. Eastern Time on January 23, 2026. Shares of our Common Stock began trading on a post-split basis on January 26, 2026. The January 2026 Reverse Stock Split had the effect of reducing the aggregate number of outstanding shares of Common Stock from 15,960,229 outstanding shares on a pre-reverse split basis as of January 23, 2026 to a total of 570,002 shares outstanding on a post-reverse split basis as of January 23, 2026.
Previously, on February 21, 2025, we effected a reverse stock split of our Common Stock at a ratio of one-for seventeen.
Unless otherwise noted, all financial information, share numbers, option numbers, warrant numbers, other derivative security numbers and exercise prices appearing in this Quarterly Report have been adjusted to give effect to the reverse stock splits described herein.
FDA Orphan Drug Designation
On June 18, 2026, the FDA granted Orphan Drug Designation to GRI-0621 for the treatment of IPF. Orphan Drug Designation is granted to therapies intended to treat rare diseases affecting fewer than 200,000 people in the United States. The designation provides important development and commercialization benefits, including potential eligibility for seven years of U.S. market exclusivity upon approval, potential tax credits related to qualified clinical development expenses, and waiver of the FDA application fee.
December 2025 Securities Purchase Agreement
On December 11, 2025, we entered into a securities purchase agreement (the December 2025 Purchase Agreement), pursuant to which we issued and sold, in a public offering (the December 2025 Offering), (i) 92,976 shares (the December 2025 Shares) of Common Stock, (ii) 287,977 pre-funded warrants (the December 2025 Pre-Funded Warrants) exercisable for an aggregate of 287,977 shares of Common Stock and (iii) 380,962 Series F common warrants (the Series F Common Warrants) exercisable for an aggregate of 380,962 shares of Common Stock. The securities were offered in combinations of (a) one December 2025 Share or one December 2025 Pre-Funded Warrant, together with (b) one Series F Common Warrant, for a combined purchase price of $21.00 (less $0.0028 for each December 2025 Pre-Funded Warrant).
The December 2025 Pre-Funded Warrants were exercisable for one share of Common Stock at a price of $0.0028 per share, were exercisable immediately and expired when exercised in full. The Series F Common Warrants are exercisable into one share of Common Stock at a price per share of $21.00 and are immediately exercisable. The Series F Common Warrants will expire on December 12, 2030. As of June 30, 2026, all of the December 2025 Pre-Funded Warrants have been exercised.
H.C. Wainwright & Co., LLC (Wainwright) acted as the exclusive placement agent in the December 2025 Offering. Pursuant to an engagement agreement, we issued to Wainwright, or its designees, warrants to purchase up to an aggregate of 26,667 shares of Common Stock (the December 2025 PA Warrants). The December 2025 PA Warrants have an exercise price of $26.25 per share, will expire on December 12, 2030 and are currently exercisable.
April 2025 Securities Purchase Agreement
On April 1, 2025, we entered into a securities purchase agreement (the April 2025 Purchase Agreement), pursuant to which we issued and sold, in a public offering (the April 2025 Offering), (i) 7,214 shares (the April 2025 Shares) of the Company's Common Stock, (ii) 42,389 pre-funded warrants (the April 2025 Pre-Funded Warrants) exercisable for an aggregate of 42,389 shares of Common Stock, (iii) 49,605 Series E-1 common stock warrants (the Series E-1 Common Warrants) to purchase up to 49,605 shares of Common Stock, (iv) 49,605 Series E-2 common stock warrants (the Series E-2 Common Warrants) to purchase up to 49,605 shares of Common Stock, and (v) 49,605 Series E-3 common stock warrants (the Series E-3 Common Warrants, and collectively with the Series E-1 Common Warrants and the Series E-2 Common Warrants, the Series E Common Warrants) to purchase up to 49,605 shares of Common Stock, for net proceeds of $4.0 million, after deducting offering expenses of $1.0 million. The securities were offered in combinations of (a) one April 2025 Share or one April 2025 Pre-Funded Warrant, together with (b) one Series E-1 Common Warrant, one Series E-2 Common Warrant and one Series E-3 Common Warrant, for a combined purchase price of $100.80 (less $0.0028 for each April 2025 Pre-Funded Warrant).
The April 2025 Pre-Funded Warrants were exercisable for one share of Common Stock at a price of $0.0028 per share, were exercisable immediately and expired when exercised in full. Each Series E Common Warrant is exercisable into one share of Common Stock at a price per share of $89.60 and is immediately exercisable. The Series E-1 Common Warrants will expire on the five-year anniversary of the date of issuance. The Series E-2 Common Warrants will expire on the 18-month anniversary of the date of issuance. The Series E-3 Common Warrants expired on the nine-month anniversary of the date of issuance.
May 2024 At The Market Offering
On May 20, 2024, we entered into an At The Market Offering Agreement (the Sales Agreement) with Wainwright, pursuant to which we may sell and issue, subject to the limitations in the Sales Agreement, up to $10.0 million of shares of our Common Stock from time to time through Wainwright as our sales agent (the ATM Offering). Under the Sales Agreement, Wainwright is entitled to compensation of 3.0% of the gross offering proceeds of all shares of Common Stock sold through it pursuant to the Sales Agreement.
On January 30, 2026, we filed a prospectus supplement to our registration statement on Form S-3 (File No. 333-279348) to increase the amount of shares of Common Stock that we may offer and sell under the Sales Agreement and applicable registration statement to an aggregate offering price of up to $60.0 million, which amount does not include the shares of Common Stock having an aggregate gross sales price of approximately $12.6 million that were sold under the ATM Offering through January 29, 2026, in accordance with the limitations set forth in Instruction I.B.6 of Form S-3.
As of June 30, 2026, we have sold 1,748,549 shares of our Common Stock in the ATM Offering at a weighted-average price of $8.22 per share, raising $14.4 million of gross proceeds and net proceeds of $13.7 million, after deducting commissions to the sales agent and other ATM Offering related expenses. During the three months ended June 30, 2026, we sold 601,182 shares of Common Stock in the ATM Offering at a weighted average price of $2.32 per share for gross proceeds of $1.4 million and net proceeds of $1.3 million. During the six months ended June 30, 2026, we sold 1,688,546 shares of Common Stock in the ATM Offering at a weighted average price of $4.86 per share for gross proceeds of $8.2 million and net proceeds of $7.9 million.
Financial Operations Overview
Research and Development Expenses
Research and development expenses include personnel costs associated with research and development activities, including third party contractors to perform research, conduct clinical trials and manufacture drug supplies and materials.
Our research and development expenses have consisted primarily of costs related to our development program for our lead product candidate GRI-0621. These expenses include:
•employee-related expenses, such as salaries, bonuses and benefits, consultant-related expenses such as consultant fees and bonuses, stock-based compensation, overhead-related expenses and travel-related expenses for our research and development personnel; and
•expenses incurred under agreements with contract research organizations, contract manufacturing organizations and research laboratories in connection with our preclinical development, process development, manufacturing and clinical development activities as well as consultants that support the implementation of our clinical and non-clinical studies.
Although our direct research and development expenses are tracked by product candidate, we do not allocate employee costs and costs associated with our discovery efforts, laboratory supplies and facilities, including other indirect costs, to specific product candidates as these costs are deployed across multiple programs. We expect our research and development expenses to increase over the next several years as we conduct our planned clinical and preclinical activities for our product candidates.
General and Administrative Expenses
General and administrative expenses consist primarily of compensation and consulting related expenses for executives and other administrative personnel, professional fees and other corporate expenses, including legal and accounting fees, travel expenses, facilities-related expenses, and consulting services relating to corporate matters.
We expect our general and administrative expenses will continue to increase as we incur costs associated with being a public company, including expenses related to services associated with maintaining compliance with The Nasdaq Capital Market and SEC requirements, directors' and officers' insurance, legal and accounting costs and investor relations costs, as well as an increase in personnel expenses as we hire additional personnel.
Interest Income
Interest income consists of interest earned on our cash and cash equivalents held with institutional banks.
Results of Operations
Comparison of the Three Months Ended June 30, 2026 and 2025
The following table summarizes the results of our operations for the periods indicated (in thousands):
| Three Months Ended June 30, | |||||||||||
| 2026 | 2025 | ||||||||||
| Operating expenses: | |||||||||||
| Research and development | $ | 407 | $ | 1,879 | |||||||
| General and administrative | 1,241 | 1,018 | |||||||||
| Total operating expenses | 1,648 | 2,897 | |||||||||
| Loss from operations | (1,648) | (2,897) | |||||||||
| Interest income | 5 | 5 | |||||||||
| Net loss | $ | (1,643) | $ | (2,892) | |||||||
Research and Development Expenses
Research and development expenses were $0.4 million and $1.9 million for the three months ended June 30, 2026 and 2025, respectively. The $1.5 million decrease in research and development expenses was primarily due to a decrease of $1.5 million in expenses related to the registration development program of GRI-0621 due to the completion of the Phase 2a clinical trial.
General and Administrative Expenses
General and administrative expenses were $1.2 million and $1.0 million for the three months ended June 30, 2026 and 2025, respectively. The $0.2 million increase was primarily related to a $0.1 million decrease in personnel expenses, including stock-based compensation expenses, offset by a $0.2 million increase in public company expenses.
Interest Income
Interest income was $5,000 in each of the three months ended June 30, 2026 and 2025.
Comparison of the Six Months Ended June 30, 2026 and 2025
The following table summarizes the results of our operations for the periods indicated (in thousands):
| Six Months Ended June 30, | |||||||||||
| 2026 | 2025 | ||||||||||
| Operating expenses: | |||||||||||
| Research and development | $ | 767 | $ | 3,520 | |||||||
| General and administrative | 2,883 | 2,429 | |||||||||
| Total operating expenses | 3,650 | 5,949 | |||||||||
| Loss from operations | (3,650) | (5,949) | |||||||||
| Interest income | 9 | 11 | |||||||||
| Net loss | $ | (3,641) | $ | (5,938) | |||||||
Research and Development Expenses
Research and development expenses were $0.8 million and $3.5 million for the six months ended June 30, 2026 and 2025, respectively. The $2.7 million decrease in research and development expenses was primarily due to a decrease of $2.6 million in expenses related to the development program of GRI-0621 as a result of the completion of the Phase 2a clinical trial.
General and Administrative Expenses
General and administrative expenses were $2.9 million and $2.4 million for the six months ended June 30, 2026 and 2025, respectively. The $0.5 million increase was primarily related to an increase of $0.6 million in public company expenses offset by a $0.2 million decrease in personnel expenses, including stock-based compensation expense.
Interest Income
Interest income was $9,000 and $11,000 for the six months ended June 30, 2026 and 2025, respectively.
Liquidity and Capital Resources
Since inception, we have incurred losses and expect to continue to incur losses for the foreseeable future. We incurred net losses of $3.6 million and $5.9 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $55.3 million.
We have financed our working capital requirements to date through the issuance of Common Stock, warrants, convertible notes and promissory notes. As of June 30, 2026, we had $10.9 million in cash.
The following table summarizes our cash flows for the periods indicated (in thousands):
| Six Months Ended June 30, | |||||||||||
| 2026 | 2025 | ||||||||||
| Net cash provided by (used in): | |||||||||||
| Operating activities | $ | (5,131) | $ | (4,902) | |||||||
| Financing activities | 7,849 | 4,996 | |||||||||
| Net increase in cash and cash equivalents | $ | 2,718 | $ | 94 | |||||||
Cash Flows from Operating Activities
For the six months ended June 30, 2026 and 2025, $5.1 million and $4.9 million were used in operating activities, respectively. The $0.2 million increase was primarily due to a $1.7 million increase in cash used for accounts payable, a $0.5 million increase in cash used for accrued expenses, a $0.2 million decrease in non-cash adjustments, primarily related to stock-based compensation expenses, and $0.2 million decrease in cash used for prepaid and other assets and operating lease liabilities, offset by a $2.3 million decrease in net loss.
Cash Flows from Financing Activities
Net cash provided by financing activities was $7.8 million for the six months ended June 30, 2026 and was primarily related to $8.2 million in proceeds from the ATM Offering, offset by $0.4 million of stock issuance costs.
Net cash provided by financing activities was $5.0 million for the six months ended June 30, 2025 and was primarily related to the $5.0 million in proceeds from the April 2025 Offering and $0.9 million in proceeds from the ATM Offering, offset by $0.9 million of stock issuance costs.
December 2025 Securities Purchase Agreement
On December 11, 2025, we entered the December 2025 Purchase Agreement, pursuant to which we issued and sold, in the December 2025 Offering, (i) 92,976 December 2025 Shares, (ii) 287,977 December 2025 Pre-Funded Warrants exercisable for an aggregate of 287,977 shares of Common Stock, and (iii) 380,962 Series F Common Warrants to purchase up to 380,962 shares of Common Stock, for net proceeds of $6.3 million, after deducting offering expenses of $1.7 million.
April 2025 Securities Purchase Agreement
On April 1, 2025, we entered the April 2025 Purchase Agreement, pursuant to which we issued and sold, in the April 2025 Offering, (i) 7,214 April 2025 Shares, (ii) 42,389 April 2025 Pre-Funded Warrants exercisable for an aggregate of 42,389 shares of Common Stock, (iii) 49,605 Series E-1 Common Warrants to purchase up to 49,605 shares of Common Stock, (iv) 49,605 Series E-2 Common Warrants to purchase up to 49,605 shares of Common Stock, and (v) 49,605 Series E-3 Common Warrants, to purchase up to 49,605 shares of Common Stock, for net proceeds of $4.0 million, after deducting offering expenses of $1.0 million.
May 2024 At The Market Offering
As of June 30, 2026, we have sold 1,748,549 shares of our Common Stock in the ATM Offering at a weighted-average price of $8.22 per share, raising $14.4 million of gross proceeds and net proceeds of $13.7 million, after deducting commissions to the sales agent and other ATM Offering related expenses. On January 30, 2026, we filed a prospectus supplement to our registration statement on Form S-3 (File No. 333-279348) to increase the amount of shares of Common Stock that we may offer and sell under the Sales Agreement and applicable registration statement to an aggregate offering price of up to $60.0 million, which amount does not include the shares of Common Stock having an aggregate gross sales price of approximately $12.6 million that were sold under the ATM Offering through January 29, 2026, in accordance with the limitations set forth in Instruction I.B.6 of Form S-3.
Nasdaq Continued Listing Requirement
On July 22, 2026, the SEC's Division of Trading and Markets, acting under delegated authority, approved a new Nasdaq continued listing requirement under which companies listed on The Nasdaq Capital Market must maintain a Market Value of Listed Securities (MVLS) of at least $5 million (the "MVLS Requirement"). On July 29, 2026, the SEC stayed the approval order after receiving petitions for Commission-level review pursuant to Rule 431(e) of the SEC's Rules of Practice, and the MVLS Requirement is not currently in effect. If the MVLS Requirement becomes effective, a company whose MVLS remains below $5 million for 30 consecutive business days, would be subject to immediate suspension of trading in and commence delisting proceedings, with no cure or compliance period to stay the suspension of trading. A company may appeal the delisting determination to the Nasdaq Hearings Panel (the Hearings Panel), but a timely request for a hearing will not automatically stay the suspension of trading. The Hearings Panel may, in its discretion, grant an exception of up to 180 days for a company to demonstrate compliance with The Nasdaq Capital Market's initial listing requirements. As of the date of this Quarterly Report, our MVLS is less than $5 million. If the MVLS Requirement becomes effective and our Common Stock were suspended and delisted from The Nasdaq Capital Market, our ability to
raise additional capital, including under the ATM Offering, would be materially and adversely affected. See Part II, Item 1A, "Risk Factors."
Future Funding Requirements
Our net losses were $3.6 million and $5.9 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had $10.9 million in cash and an accumulated deficit of $55.3 million. We expect to devote substantial financial resources to our planned activities, particularly as we prepare for, initiate, and conduct our planned clinical trials of GRI-0621 and GRI-0803, advance our discovery programs and continue our product development efforts. In addition, we expect to incur additional costs associated with operating as a public company.
Based on our current operating plan, we believe that our existing cash and cash equivalents will be sufficient to fund out currently planned operating expenses and capital expenditure requirements through the second quarter of 2027. However, this estimate assumes that we only continue the preliminary work towards the initiation of additional clinical studies of GRI-0621; we would not be able to complete the additional clinical studies for GRI-0621, which will require substantial additional capital or resources.
We intend to raise capital through additional issuances of equity securities and/or short-term or long-term debt arrangements, and potentially through strategic partner and collaboration agreements, but there can be no assurances any such financing, collaborations or partnering opportunities will be available when needed on acceptable terms, or at all, even if our research and development efforts are successful. If we are unable to secure adequate additional funding when needed or on acceptable terms, we will need to reevaluate our operating plans and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, delay, scale back or eliminate some or all of our development programs, or relinquish rights to our technology on less favorable terms than we would otherwise choose or cease operations entirely. These actions could materially impact our business, results of operations and future prospects and the value of shares of our Common Stock. In addition, attempting to secure additional financing may divert the time and attention of management from day-to-day activities and distract from our discovery and product development efforts. As a result, there is substantial doubt about our ability to continue as a going concern. We expect to continue to incur significant and increasing operating losses at least for the foreseeable future. We do not expect to generate product revenue unless and until we successfully complete development, obtain regulatory approval for and successfully commercialize our current, or any future, product candidates.
In addition, as described in Part II, Item 1A, "Risk Factors," although the new MVLS continued listing requirement approved on July 22, 2026 has been stayed pending Commission-level review, our MVLS is currently less than $5 million. If the requirement becomes effective and our Common Stock is suspended from trading or delisted from The Nasdaq Capital Market, our ability to raise capital under the ATM Offering or otherwise access the public markets would be impaired, which would further exacerbate the risks described above and our substantial doubt about our ability to continue as a going concern.
Off-Balance Sheet Arrangements
We are not party to any off-balance sheet transactions. We have no guarantees or obligations other than those which arise out of normal business operations.
Critical Accounting Policies and Estimates
Our management's discussion and analysis of its financial condition and results of operations is based on its unaudited interim consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (GAAP). The preparation of these unaudited interim consolidated financial statements requires us to make estimates and assumptions that affect the amounts reported in the unaudited interim consolidated financial statements and accompanying notes. Management evaluates these estimates and judgments on an ongoing basis. Management bases its estimates on historical experience and on various other factors that it believes are reasonable under the circumstances. Actual results could differ from those estimates.
Our significant accounting policies are described in more detail in Note 3, "Summary of Significant Accounting Policies", in our Annual Report.
Emerging Growth Company Status
We are an "emerging growth company," as defined in the Jumpstart Our Business Startups Act of 2012 (the JOBS Act) and may remain an emerging growth company for up to five years. For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not applicable to emerging growth companies. These exemptions include:
•reduced disclosure about our executive compensation arrangements;
•no non-binding stockholder advisory votes on executive compensation or golden parachute arrangements; and
•exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting.
We have taken advantage of reduced reporting requirements in this report and may continue to do so until such time that we are no longer an emerging growth company. We will remain an "emerging growth company" until the earliest of (a) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more, (b) December 31, 2026, the last day of the fiscal year following the fifth anniversary of the completion of Vallon's initial public offering, (c) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years or (d) the date on which we are deemed to be a large accelerated filer under the rules of the SEC. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period for complying with new or revised accounting standards.
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