# Ocugen, Inc.: Form 10-Q for the period ended Jun 30, 2026

- Company: [Ocugen, Inc.](/companies/ocgn.md) (CIK 1372299)
- Form: 10-Q
- Filed: 2026-08-06
- Accepted by EDGAR: Aug 6, 2026, 16:15 ET
- Period: 2026-06-30
- Accession: 0001628280-26-054057
- Inline XBRL: yes
- Main document: https://www.sec.gov/Archives/edgar/data/1372299/000162828026054057/ocgn-20260630.htm
- All documents and exhibits: https://www.sec.gov/Archives/edgar/data/1372299/000162828026054057/

## Figures reported in this filing

Standardized XBRL line items for the period ended 2026-06-30.

| Line item | Period | Value | XBRL concept |
| --- | --- | ---: | --- |
| Revenue | 3 months, 2026-04-01 to 2026-06-30 | $1.5m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax |
| Revenue | 6 months, 2026-01-01 to 2026-06-30 | $3.0m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax |
| Research and development | 3 months, 2026-04-01 to 2026-06-30 | $10.7m | us-gaap:ResearchAndDevelopmentExpense |
| Research and development | 6 months, 2026-01-01 to 2026-06-30 | $21.9m | us-gaap:ResearchAndDevelopmentExpense |
| Operating income | 3 months, 2026-04-01 to 2026-06-30 | −$16.4m | us-gaap:OperatingIncomeLoss |
| Operating income | 6 months, 2026-01-01 to 2026-06-30 | −$34.3m | us-gaap:OperatingIncomeLoss |
| Interest expense | 3 months, 2026-04-01 to 2026-06-30 | $4.5m | us-gaap:InterestExpenseNonoperating |
| Interest expense | 6 months, 2026-01-01 to 2026-06-30 | $5.8m | us-gaap:InterestExpenseNonoperating |
| Net income | 3 months, 2026-04-01 to 2026-06-30 | −$24.9m | us-gaap:NetIncomeLoss |
| Net income | 6 months, 2026-01-01 to 2026-06-30 | −$44.1m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months, 2026-04-01 to 2026-06-30 | −$0.07 | us-gaap:EarningsPerShareDiluted |
| Diluted EPS | 6 months, 2026-01-01 to 2026-06-30 | −$0.13 | us-gaap:EarningsPerShareDiluted |
| Basic EPS | 3 months, 2026-04-01 to 2026-06-30 | −$0.07 | us-gaap:EarningsPerShareBasic |
| Basic EPS | 6 months, 2026-01-01 to 2026-06-30 | −$0.13 | us-gaap:EarningsPerShareBasic |
| Diluted shares (weighted) | 3 months, 2026-04-01 to 2026-06-30 | 338,679,856 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Diluted shares (weighted) | 6 months, 2026-01-01 to 2026-06-30 | 333,142,618 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Operating cash flow | 6 months, 2026-01-01 to 2026-06-30 | −$34.0m | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Capital expenditure | 6 months, 2026-01-01 to 2026-06-30 | $27.0k | us-gaap:PaymentsToAcquirePropertyPlantAndEquipment |
| Cash and equivalents | at 2026-06-30 | $100.1m | us-gaap:CashAndCashEquivalentsAtCarryingValue |
| Current assets | at 2026-06-30 | $106.7m | us-gaap:AssetsCurrent |
| Total assets | at 2026-06-30 | $124.2m | us-gaap:Assets |
| Current liabilities | at 2026-06-30 | $133.1m | us-gaap:LiabilitiesCurrent |
| Total liabilities | at 2026-06-30 | $140.8m | us-gaap:Liabilities |
| Long-term debt | at 2026-06-30 | $1.7m | us-gaap:LongTermDebtNoncurrent |
| Current portion of debt | at 2026-06-30 | $20.0k | us-gaap:LongTermDebtCurrent |
| Shareholders' equity | at 2026-06-30 | −$16.6m | us-gaap:StockholdersEquity |

## Management's discussion and analysis

As filed, 35,219 characters.

*You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited financial statements for the year ended December 31, 2025, included in our 2025 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, include forward-looking statements that involve risks, uncertainties, and assumptions. These statements are based on our beliefs and expectations about future outcomes and are subject to risks and uncertainties that could cause our actual results to differ materially from anticipated results. Except as required by law, we undertake no obligation to publicly update these forward-looking statements, whether as a result of new information, future events, or otherwise. You should read the "Risk Factors" section included in our 2025 Annual Report and First Quarter 10-Q and "Disclosure Regarding Forward-Looking Statements" section of this Quarterly Report on Form 10-Q for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.*

### tOverview

We are a biotechnology company focused on discovering, developing, and commercializing novel gene therapies that improve health and offer hope for patients across the globe.

Our technology pipeline includes:

**Novel Modifier Gene Therapy Platform —**

We are developing a modifier gene therapy platform designed to fulfill unmet medical needs related to retinal diseases, including inherited retinal degenerations ("IRDs"), such as retinitis pigmentosa ("RP"), Stargardt disease ("ST"), and multifactorial diseases such as dry age-related macular degeneration ("dAMD"). Our modifier gene therapy platform is based on the use of nuclear hormone receptors ("NHRs"), which have the potential to achieve homeostasis — the basic biological processes in the retina to restore a healthy state from a diseased state. Unlike single gene replacement therapies, which only target one genetic mutation, our modifier gene therapy platform, through its use of NHRs, represents a gene-agnostic approach designed to address not just the mutated gene but provide a molecular "reset" of health and survival of gene networks.

**OCU400**- our first modifier gene therapy product is based on the use of NHRs, and we believe our novel modifier gene therapy platform has the potential to address major blindness diseases, including rare genetic diseases such as RP, with a gene-agnostic approach. OCU400 is intended for early to advanced cases of RP including clinical and/or genetic diagnosis with both syndromic and non-syndromic forms of the disease. In January 2025, we announced positive two-year data for multiple mutations from the Phase 1/2 clinical trial for OCU400. In February 2025, we announced that the European Commission ("EC") has provided a positive opinion from the European Medicines Agency's ("EMA") Committee for Advanced Therapies for OCU400 Advanced Therapy Medicinal Product ("ATMP") classification. Positive long-term, 3-year Phase 1/2 data for OCU400 were assessed in evaluable subjects and built on prior 2-year results showing consistent clinically meaningful, approximately 2-line low luminance visual acuity ("LLVA") gain across mutations. OCU400 maintained a favorable durability, safety and tolerability profile with no new treatment-related serious adverse events or adverse events of interest emerged.

Additional Phase 1/2 data include:

- Visual function benefits were consistently observed over 3 years, with 88% (7/8) of evaluable treated subjects showing improvement or preservation versus untreated fellow eyes; and,
- Approximately 2-line gain (N=8) observed across multiple mutation types in treated eyes compared to untreated eyes at 3 years.

We have completed enrollment in the Phase 3 liMeliGhT clinical trial for OCU400 (N=140 subjects), reflecting strong interest from investigators and patients. Topline Phase 3 data is expected in the first quarter of 2027, advancing OCU400 towards potential approval in the fourth quarter of 2027 as a treatment option for early- to late stage RP. The U.S. Food and Drug Administration ("FDA") acknowledged the regulatory eligibility to rolling BLA submission by virtue of our RMAT designation for OCU400, but, under the FDA’s general policy, we would need to submit topline Phase 3 data in a pre-BLA meeting prior to the FDA agreeing to a rolling submission schedule.

OCU400 has received Orphan Drug Designations ("ODD") from the FDA for RP and Leber congenital amaurosis ("LCA"), a Regenerative Medicine Advanced Therapy ("RMAT") designation for the treatment of RP associated with NR2E3 and RHO mutations from the FDA, and orphan medicinal product designation ("OMPD") from the European Commission ("EC"), based on the recommendation of the European Medicines Agency ("EMA"), for RP and LCA. These broad ODD, RMAT, and OMPD designations further support the broad (gene-agnostic) therapeutic potential of OCU400 to treat RP associated with mutations in multiple genes. We have successfully completed process performance qualification ("PPQ") batches in preparation for potential approval in the fourth quarter of 2027 as a treatment option for early- to late-stage RP.

OCU410ST/OCU410 utilizes a first-in-class modifier gene therapy approach by delivering the human RORA (Retinoic Acid Receptor ("RAR") Related Orphan Receptor A) gene to diseased retinal tissue via subretinal AAV5 delivery. RORA modulates lipid metabolism, oxidative stress, and inflammation key drivers of retinal degeneration that restores retinal homeostasis by offering a unique four-way disease-modifying potential. OCU410 is a potential one-time therapy with a single sub-retinal injection that targets multiple pathways associated with AMD pathogenesis, in contrast to products currently approved or under development that treat only one cause of GA that require multiple injections per year, and some safety limitations. Currently, there is significant economic burden of vision loss diseases in the United States. ST and GA are major contributors to vision loss. We believe OCU410 has the potential to reduce treatment costs, prevent vision-related disability, and ease the broader healthcare and societal burden driven by structural and functional vision loss. OCU410ST has received OMPD from the EMA for the treatment of ABCA4-associated retinopathies (\>1200 mutations) including ST, retinitis pigmentosa 19 ("RP19"), and cone-rod dystrophy 3 ("CORD3"), and has the potential to be the first approved therapy to treat ST.

**OCU410ST** - We initiated dosing in GARDian3 pivotal confirmatory trial for OCU410ST in July 2025. The OCU410ST Phase 2/3 pivotal confirmatory trial represents our second late-stage clinical program. We plan to submit a BLA for OCU410ST by mid-2027 in alignment with our strategic goal of filing three BLAs by 2028. OCU410ST has received ODD from the FDA. In November 2024, the EMA granted OMPD for OCU410ST for the treatment of ABCA4-associated retinopathies (\>1200 mutations) including ST, RP 19, and CORD3. In May 2025, we announced that the FDA granted Rare Pediatric Disease Designation ("RPDD") for OCU410ST for the treatment of ABCA4-associated retinopathies including ST, RP19, and CORD3. In June 2025, we announced that the FDA has cleared the Investigational New Drug ("IND") amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy candidate being developed for all ST (ABCA4-associated retinopathies). In August 2025, we announced that the Committee for Medicinal Products for Human Use ("CHMP") of the EMA reviewed the study design, endpoints and planned statistical analysis of the ongoing pivotal confirmatory OCU410ST Phase 2/3 GARDian3 clinical trial for ST and provided acceptability of a single U.S.-based trial for submission of a Marketing Authorization Application ("MAA").

The OCU410ST Phase 1 clinical trial demonstrated that atrophic lesions grew slower by 54% at 12 months for evaluable treated eyes compared to untreated fellow eyes. In the secondary endpoint- Best Corrected Visual Acuity ("BCVA" ), treated-eyes showed an improvement with 1-line (6 ETDRS Letter) gain in the visual acuity when compared to untreated fellow eyes. Additionally, 100% of evaluable treated eyes demonstrated stabilization or improvement vs. untreated eyes in visual function. In evaluable subjects (N=6) the rate of ellipsoid zone ("EZ") loss was 116% slower in OCU410ST-treated eyes compared to untreated fellow eyes at 12 months, demonstrating preservation or stabilization in photoreceptor integrity. The untreated eyes showed expected decline in atrophy. In April 2026, we announced early completion of dosing in the Phase 2/3 pivotal confirmatory trial (N=63 subjects). GARDian 3 trial enrollment and dosing completed successfully in less than 9 months. We plan to submit the BLA for OCU410ST by mid-2027.

**OCU410-** In Phase 1 study, no OCU410-related serious adverse events were observed and no cases of endophthalmitis, retinal detachment, vasculitis, choroidal neovascularization, or ischemic optic neuropathy were reported to date. The Phase 2 clinical trial was built directly on the clean safety profile observed for OCU410 in the Phase 1 study.

We completed dosing in Phase 2 of the Phase 1/2 ArMaDa clinical trial for OCU410 for the treatment of geographic atrophy ("GA"), an advanced form of dAMD. Positive preliminary efficacy and safety data from the Phase 1 dose-escalation portion of the OCU410 Phase 1/2 ArMaDa clinical trial included: no drug-related serious adverse events ("SAEs"), reduced lesion growth, preservation of retinal tissue. In March 2025, OCU410 and OCU410ST received ATMP classification from the EMA.

In March 2026 we announced positive 12-month topline data from the Phase 2 ArMaDa clinical trial. Key findings from Phase 2 include:

- 31% reduction in lesion growth in the optimal dose (medium) group compared to control (p\< 0.05)
- 27% slower rate of EZ loss compared to control, indicating structural preservation of photoreceptors, which correlates with visual function; and
- 55% of treated patients demonstrated ≥30% lesion size reduction vs. control

In July 2026, we announced that the FDA granted RMAT designation to the Company’s investigational product OCU410 for the treatment of GA, secondary to dAMD.

In August 2026, we have received FDA clearance for the Phase 3 registrational trial (ArMaDa3) for GA secondary to dry age-related macular degeneration, anchored by positive 12-month Phase 2 ArMaDa data (statistically significant 31% reduction in GA lesion growth (patient population: lesion size ≥2.5 mm2 and ≤17.5 mm2) versus control, p\<0.05, at the optimal dose planned for Phase 3). We plan to initiate the Phase 3 study late in the third quarter of 2026.

### Other Programs —

**Novel Biologic Therapy for Retinal Diseases —** OCU200 is a novel recombinant fusion protein consisting of two human proteins, tumstatin and transferrin. OCU200 possesses unique features which potentially enable it to treat vascular complications of diabetic macular edema ("DME"), diabetic retinopathy ("DR"), and wet age-related macular degeneration ("AMD"). Tumstatin is the active component of OCU200 and binds to integrin receptors, which play a crucial role in disease pathogenesis. Transferrin is expected to facilitate the targeted delivery of tumstatin into the retina and choroid and potentially help increase the interaction between tumstatin and integrin receptors. OCU200 Phase 1 clinical trial enrollment was completed in the first quarter of 2026.

**Inhaled Mucosal Vaccine Platform —** Our next-generation, inhaled mucosal vaccine platform includes OCU500, a COVID-19 vaccine. We have completed IND-enabling studies and GMP manufacturing of clinical trial material for OCU500. The Company is collaborating with the National Institute of Allergy and Infectious Diseases ("NIAID"), part of the National Institutes of Health, for the Phase 1 clinical trial for OCU500. NIAID is responsible for conducting and funding these studies, including contracting with clinical sites and service providers. The Company supplies investigational product for use in the studies and incurs only those costs for which it is directly responsible. Accordingly, costs funded directly by NIAID are not included in the Company's research and development expenses. NIAID initiated Phase 1 clinical trial for OCU500 in the second quarter of 2026.

### 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 three months ended June 30, 2026 and 2025 (in thousands):

|  | Three months ended June 30, 2026 | 2025 | Change |
| --- | ---: | ---: | ---: |
| Collaborative arrangement revenue | $1,488 | $1,373 | $115 |
| Total Revenue | 1,488 | 1,373 | 115 |
| Operating expenses |  |  |  |
| Research and development | 10,690 | 8,402 | 2,288 |
| General and administrative | 7,242 | 6,766 | 476 |
| Total operating expenses | 17,932 | 15,168 | 2,764 |
| Loss from operations | (16,444) | (13,795) | (2,649) |
| Other income (expense): |  |  |  |
| Interest income | $395 | $227 | $168 |
| Interest expense | $(4,476) | $(1,285) | $(3,191) |
| Loss on extinguishment of debt | (2,383) | $— | $(2,383) |
| Change in fair value of derivative liability | (1,891) | — | $(1,891) |
| Other (expense) income, net | (78) | $114 | $(192) |
| Total other (expense) income | (8,433) | $(944) | $(7,489) |
| Net loss | $(24,877) | $(14,739) | $(10,138) |

The following table summarizes our research and development expenses by product candidate for the three months ended June 30, 2026 and 2025 (in thousands):

|  | Three months ended June 30, 2026 | 2025 | Change |
| --- | ---: | ---: | ---: |
| OCU400 | $2,211 | $1,998 | $213 |
| OCU410 and OCU410ST | 1,590 | 1,117 | 473 |
| NeoCart | 196 | 8 | 188 |
| COVAXIN | 3 | — | 3 |
| Inhaled mucosal vaccine platform | 49 | 131 | (82) |
| OCU200 | 55 | 151 | (96) |
| Unallocated costs: |  |  |  |
| Research and development personnel costs | 5,150 | 4,091 | 1,059 |
| Facilities and other support costs | 842 | 834 | 8 |
| Other | 594 | 72 | 522 |
| Total research and development | $10,690 | $8,402 | $2,288 |

### Collaborative arrangement revenue

Collaborative arrangement revenue increased by $0.1 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was due to our quarterly reassessment of the amount of co-development services provided by us to the business partner in the collaboration agreement.

### Research and development expense

Research and development expense increased by $2.3 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to increases of $1.1 million related to personnel costs, $0.5 million related to OCU410ST clinical trial expenses, and $0.5 million related to shared research and development expenses.

### General and administrative expense

General and administrative expense increased by $0.5 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to an increase of $0.8 million related to personnel costs and $0.5 million related to professional services. This is offset by a decrease of $0.4 million in commercial expenses, $0.2 million in corporate business fees, and $0.2 million in employee related expenses.

### Interest income

Interest income increased by $0.2 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to a higher average cash balance for the three months ended June 30, 2026.

### Interest expense

Interest expense, net increased by $3.2 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due a $1.4 million increase related to the coupon interest on our debt and on the Convertible Senior Notes due 2034 ("Convertible Notes") issued in May due semi-annually and amortization of the issuance cost of $1.8. million.

### Loss on extinguishment of debt

The loss on extinguishment of debt of $2.4 million for the three months ended June 30, 2026, was a result of the payoff of our Avenue Capital Loan.

### Change in fair value of derivative liability

The change in fair value of the derivative liability for the three months ended June 30, 2026, resulted in a $1.9 million loss related to the derivative liability associated with the Convertible Notes.

### Other (expense)/income, net

Other (expense)/income, net changed by $(0.2) million with other expense of $(0.1) million for the three months ended June 30, 2026 compared to other income of $0.1 million for the three months ended June 30, 2025, primarily due to exchange rate fluctuation.

### Comparison of the Six Months Ended June 30, 2026 and 2025

The following table summarizes the results of our operations for the six months ended June 30, 2026 and 2025 (in thousands):

|  | Six months ended June 30, 2026 | 2025 | Change |
| --- | ---: | ---: | ---: |
| Collaboration revenue | $3,022 | $2,854 | $168 |
| Total revenues | $3,022 | $2,854 | $168 |
| Operating expenses |  |  |  |
| Research and development | $21,945 | $17,932 | $4,013 |
| General and administrative | 15,359 | 13,218 | 2,141 |
| Total operating expenses | $37,304 | $31,150 | $6,154 |
| Loss from operations | (34,282) | (28,296) | (5,986) |
| Other income (expense): |  |  |  |
| Interest income | $526 | $571 | $(45) |
| Interest expense | (5,796) | (2,543) | (3,253) |
| Loss on extinguishment of debt | (2,383) | — | (2,383) |
| Change in fair value of derivative liability | (1,891) | — | (1,891) |
| Other (expense) income, net | (228) | 179 | (407) |
| Total Other (expense) income, net | $(9,772) | $(1,793) | $(7,979) |
| Net loss | $(44,054) | $(30,089) | $(13,965) |

The following table summarizes our research and development expenses by product candidate for the six months ended June 30, 2026 and 2025 (in thousands):

|  | Six months ended June 30, 2026 |  | 2025 |  | Change |
| --- | ---: | ---: | ---: | ---: | ---: |
| OCU400 | $3,520 |  | 3,843 | 3,843 | $(323) |
| OCU410 and OCU410ST | 3,966 |  | 2,295 | 2,295 | 1,671 |
| NeoCart | 218 |  | 5 | 5 | 213 |
| COVAXIN | 10 |  | — | — | 10 |
| Inhaled mucosal vaccine platform | 79 |  | 319 | 319 | (240) |
| OCU200 | 260 |  | 400 | 400 | (140) |
| Unallocated costs: |  |  |  |  |  |
| Research and development personnel costs | 10,752 |  | 8,106 | 8,106 | 2,646 |
| Facilities and other support costs | 1,675 |  | 1,815 | 1,815 | (140) |
| Other | 1,465 |  | 1,149 | 1,149 | 316 |
| Total research and development | $21,945 | $— | $17,932 | $17,932 | $4,013 |

### Collaborative arrangement revenue

Collaborative arrangement revenue increased by $0.2 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was due to our quarterly reassessment of the amount of co-development services provided by us to the business partner in the collaboration agreement.

### Research and development expense

Research and development expense increased by $4.0 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to an increase of $2.6 million related to personnel costs, and an increase of $1.7 million in OCU410ST clinical trial expenses.

### General and administrative expense

General and administrative expense increased by $2.1 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to increases of $1.3 million in stock based compensation and $0.8 million in personnel related expenses.

### Interest income

The decrease in interest income for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was minimal, driven by a lower average cash balance for the quarter ending March 31, 2026.

### Interest expense

Interest expense, net increased by $3.3 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to a $1.4 million increase related to the coupon interest on our debt and on the Convertible Notes issued in May due semi-annually and amortization of the issuance cost of $1.9 million.

### Loss on extinguishment of debt

The loss on extinguishment of debt of $2.4 million for the six months ended June 30, 2026, was a result of the payoff of our Avenue Capital Loan.

### Change in fair value of derivative liability

The change in fair value of the derivative liability for the six months ended June 30, 2026, was a $1.9 million loss on the fair value of its derivative liability recorded in association with the Convertible Notes.

### Other (expense)/income, net

Other (expense)/income, net changed by $(0.4) million with other expense of $(0.2) million for the six months ended June 30, 2026 compared to other income of $0.2 million for the six months ended June 30, 2025, primarily due to exchange rate fluctuation.

### Liquidity and Capital Resources

As of June 30, 2026, we had approximately $100.1 million of cash and cash equivalents, along with $0.3 million of restricted cash. To date, we have not generated revenue from our product candidates. Our operations have been financed primarily through the sale of common stock, warrants, convertible notes and other debt instruments, as well as grant funding. Since our inception and through June 30, 2026, we have raised an aggregate $558.4 million to fund our operations, of which $383.7 million was from gross proceeds from the sale of our common stock and warrants, $140.3 million was from the issuance of convertible notes, $33.4 million was from the issuance of indebtedness, $0.8 million was from the royalty agreement and $0.2 million was from grant proceeds.

Since our inception, we have devoted substantial resources to research and development and have incurred significant net losses and may continue to incur net losses in the future. We incurred net losses of approximately $(44.1) million and $(30.1) million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $452.1 million. In addition, we had accounts payable and accrued expenses and other current liabilities of $16.2 million and indebtedness of $116.6 million.

The following table provides a summary of our cash flows for the six months ended June 30, 2026 and 2025 (in thousands):

|  | Six months ended June 30, 2026 | 2025 |
| --- | ---: | ---: |
| Net cash used in operating activities | $(33,992) | $(30,087) |
| Net cash used in investing activities | (27) | (190) |
| Net cash provided by (used in) financing activities | 115,352 | (1,184) |
| Effect of changes in exchange rate on cash and restricted cash | 151 | (36) |
| Net increase (decrease) in cash, cash equivalents and restricted cash | $81,484 | $(31,497) |

In May 2026, we completed a private offering of $130.0 million aggregate principal amount of Convertible Notes, generating net proceeds of approximately $112.5 million after discounts, commissions, and offering expenses. We used approximately $32.7 million of the net proceeds from this offering, to fully repay and terminate our Avenue Capital Loan with the remaining proceeds available for general corporate purposes. The Convertible Notes are general unsecured obligations and bear interest at a rate of 6.75% per year payable semi-annually in arrears on May 15 and November 15 of each year, beginning on November 15, 2026. The Convertible Notes mature on May 15, 2034, unless earlier repurchased, redeemed or converted.

#### Operating activities

Cash used in operating activities was $34.0 million for the six months ended June 30, 2026, and primarily consisted of a net loss of $44.1 million adjusted for non-cash items including amortization of debt issuance cost of $0.6 million, stock-based compensation of $5.2 million, depreciation and amortization of $1.2 million, non-cash lease expense of $0.6 million, non-cash expense from collaborative arrangements, net of $1.7 million, change in fair value of derivative liability $1.9 million, and loss on extinguishment of debt $2.4 million related to repayment of the Avenue Capital Loan.

Cash used in operating activities was $30.1 million for the six months ended June 30, 2025, and primarily consisted of a net loss of $30.1 million adjusted for non-cash items including stock-based compensation of $3.7 million, non-cash expense from collaborative arrangements, net of $1.8 million, non-cash lease expense of $0.6 million, and depreciation and amortization of $1.8 million.

#### Investing activities

Cash used in investing activities was $(0.03) million for the six months ended June 30, 2026, and primarily consisted of purchase of fixed assets. Cash used in investing activities was $(0.2) million for the six months ended June 30, 2025, were which primarily consisted of payments related to security deposits and the purchases of property and equipment.

#### Financing activities

Cash provided by financing activities was $115.4 million for the six months ended June 30, 2026 compared to cash used in financing activities of $1.2 million for the six months ended June 30, 2025. During the six months ended June 30, 2026, cash provided by financing activities increased primarily due to the issuance of Convertible Notes in May 2026, proceeds from the equity offering in January 2026 and exercise of warrants, offset by the repayment of our Avenue Capital Loan and other cost related to the issuance of our Convertible Notes. During the six months ended June 30, 2025, cash used in financing activities primarily consisted of the repayment of EB-5 loans.

### Contractual Obligations

We have commitments under certain licensing and development agreements, lease obligations, debt agreements, and consulting agreements. Except in connection with the issuance of Convertible Notes pursuant to the Indenture in May 2026, as described in this Quarterly Report on Form 10-Q, there have been no material changes to our contractual obligations as reported in our 2025 Annual Report.

### Funding requirements

We expect to continue to incur significant expenses in connection with our ongoing activities, particularly as we continue research and development, including preclinical and clinical development of our product candidates, prepare to manufacture our product candidates, prepare for the potential commercialization of our product candidates, add operational, financial, and information systems to execute our business plan, maintain, expand, and protect our patent portfolio, explore strategic licensing, acquisition, and collaboration opportunities to expand our product candidate pipeline to support our future growth; expand headcount to support our development, commercialization, and business efforts, and operate as a public company.

Factors impacting our future funding requirements include, without limitation, the following:

- the initiation, progress, timing, costs, and results of clinical trials for our product candidates;
- the preparation and submission of Investigational New Drug applications, or INDs, with the FDA for current and future product candidates;
- the outcome, timing, and cost of the regulatory approval process for our product candidates;
- the timing and terms of the conversion of Convertible Notes under the Indenture;
- the costs of manufacturing and commercialization;
- the costs related to doing business internationally with respect to the development and commercialization of our product candidates;
- the cost of filing, prosecuting, defending, and enforcing our patent claims and other intellectual property rights;
- the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us;
- the acquisition of or in-licensing of additional product candidates and technologies;
- the costs of expanding infrastructure to support our development, commercialization, and business efforts, including the costs related to the development of a laboratory and manufacturing facility;
- the costs involved in recruiting and retaining skilled personnel;
- the extent to which we in-license or acquire other products, product candidates, or technologies and out-license our product candidates;
- the impact of geopolitical turmoil, macroeconomic conditions, social unrest, political instability, terrorism, or other acts of war; and
- the changes in tariffs and indirect trade restraints, including increased costs associated with global and retaliatory tariff policies.

We have incurred recurring operating losses, generated negative cash flows from operations, and expects to continue to incur significant expenditures to support the research, development, and potential commercialization of its product candidates. We have funded our operations to date through the sale of common stock, warrants to purchase common stock, the issuance of convertible notes and debt, and grant proceeds. We have incurred net losses of approximately $44.1 million and $30.1 million for the six months ended June 30, 2026 and 2025, respectively. We have incurred net losses of approximately $24.9 million and $14.7 million for the three months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $452.1 million and cash and cash equivalents totaling $100.1 million.

In January 2026, we raised approximately $20.7 million in net proceeds through an underwritten registered direct offering of shares of common stock. In March 2026, investors partially exercised outstanding warrants, resulting in $14.2 million in net proceeds. In May 2026, we completed a private offering of $130.0 million aggregate principal amount of Convertible Notes, generating net proceeds of approximately $112.5 million after discounts, commissions, and offering expenses. We used approximately $32.7 million of the net proceeds from this offering to fully repay and terminate the Avenue Capital Loan, with the remaining proceeds available for general corporate purposes.

Management believes these financing transactions strengthened our financial position and, based on our current cash, cash equivalents, and anticipated operating plans, provide us with increased flexibility to fund our operations and strategic priorities. However, management’s going concern assessment requires consideration of all known and reasonably knowable conditions and events through one year from the issuance date of these condensed consolidated financial statements, including our recurring operating losses, expected negative cash flows from operations, future clinical and commercialization expenditures, and obligations and uncertainties related our financing arrangements, including potential settlement and share reservation considerations associated with the convertible notes.

After evaluating these conditions and management’s plans, we have concluded that there is substantial doubt about our ability to continue as a going concern within one year after the date these condensed consolidated financial statements are issued. Management continues to evaluate and pursue plans to mitigate these conditions, which may include raising additional capital, managing the timing and scope of operating expenditures, pursuing strategic partnerships or licensing arrangements, and other financing or corporate transactions. There can be no assurance that such plans will be successfully implemented, that additional financing will be available on acceptable terms, or at all, or that we will be able to execute our strategic plans within the required timeframe. If we are unable to obtain additional funding or otherwise successfully execute our plans when needed, we may be required to delay, reduce, or eliminate certain research and development programs and, commercialization activities, consider various strategic alternatives, including a merger or sale, or cease our operations.

### Off-Balance Sheet Arrangements

We did not have any off-balance sheet arrangements during the periods presented, and we do not currently have any off-balance sheet arrangements as defined in the rules and regulations of the SEC.

### Critical Accounting Policies and Significant Judgments and Estimates

The preparation of financial statements in conformity with GAAP requires us to make judgments, estimates, and assumptions in the preparation of our condensed consolidated financial statements. Actual results could differ from those estimates. There have been no material changes to our critical accounting policies and estimates as reported in our 2025 Annual Report except as noted below:

### Derivative Liability

During the quarter ended June 30,2026, the Company adopted an accounting policy for derivative liabilities in connection with the issuance of convertible notes containing embedded conversion options that require bifurcation and separate accounting as derivative instruments under ASC 815, Derivatives and Hedging. As this is the first time the Company has entered into transactions containing such features, the adoption of this accounting policy relates to a new type of transaction and does not represent a change in accounting principle.

The Company evaluates the terms of its convertible instruments at issuance and at each reporting date to determine whether embedded conversion features require bifurcation from the host debt instrument. When bifurcation is required, the embedded conversion option is initially recognized as a derivative liability at fair value on the issuance date. The debt host is initially recorded at the residual amount after allocating the proceeds to the derivative liability. The derivative liability is subsequently remeasured at fair value at each reporting date, with changes in fair value recognized in the condensed consolidated statements of operations. The debt discount resulting from the initial allocation to the derivative liability is amortized to interest expense over the contractual term of the convertible notes using the effective interest method.

The fair value of the derivative liability is determined using appropriate valuation techniques that incorporate observable market data, when available, and significant unobservable inputs, as necessary. Accordingly, the derivative liability is generally classified within Level 3 of the fair value hierarchy.

### Recently Adopted Accounting Pronouncements

For a discussion of recently adopted accounting pronouncements, see Note 2 in the notes to the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

## Controls and procedures

As filed, 1,871 characters.

### Evaluation of Disclosure Controls and Procedures

We have carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of June 30, 2026. Based upon this evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures are effective in ensuring that (a) the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC's rules and forms, and (b) such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosures. In designing and evaluating our disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

### Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the three months ended June 30, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

## Risk factors

As filed, 331 characters.

There have been no material changes in our risk factors as previously disclosed in our 2025 Annual Report and in the First Quarter 10-Q. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially adversely affect our business, financial condition, or future results.

Filed Aug 6, 2026.
Source: SEC EDGAR, the filing index for accession 0001628280-26-054057. Last ingested by Listed: Oct 24, 2026, 15:12 ET. No prices; not investment advice.