# EDGAR Filing Document

**Accession Number:** 0001603454
**File Stem:** 0001493152-25-021903
**Filing Date:** 2025-11
**Character Count:** 27268
**Document Hash:** 13cb229b82c5eaf9dd5d9940374a85f0
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-25-021903.hdr.sgml**: 20251112

**ACCESSION NUMBER**: 0001493152-25-021903

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20251112

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251112

**DATE AS OF CHANGE**: 20251112

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Celcuity Inc.
- **CENTRAL INDEX KEY:** 0001603454
- **STANDARD INDUSTRIAL CLASSIFICATION:** SERVICES-MEDICAL LABORATORIES [8071]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38207
- **FILM NUMBER:** 251472640

**BUSINESS ADDRESS:**
- **STREET 1:** 16305 36TH AVENUE N
- **STREET 2:** SUITE 100
- **CITY:** MINNEAPOLIS
- **STATE:** MN
- **ZIP:** 55446
- **BUSINESS PHONE:** 763-392-0767

**MAIL ADDRESS:**
- **STREET 1:** 16305 36TH AVENUE N
- **STREET 2:** SUITE 100
- **CITY:** MINNEAPOLIS
- **STATE:** MN
- **ZIP:** 55446

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Celcuity LLC
- **DATE OF NAME CHANGE:** 20140324

?xml version='1.0' encoding='ASCII'?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the**

**Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported): November 12, 2025**

**Celcuity Inc.**

**(Exact name of Registrant as Specified in its Charter)**

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-38207** | **82-2863566** |
| **(State or Other Jurisdiction**<br> **of Incorporation)** | **(Commission**<br> **File Number)** | **(IRS Employer**<br> **Identification No.)** |

---

**16305 36th Avenue North; Suite 100 Minneapolis, Minnesota 55446** 

**(Address of Principal Executive Offices and Zip Code)**

**(763) 392-0767** 

**(Registrant's telephone number, including area code)**

**Not Applicable**

**(Former Name or Former Address, if Changed Since Last Report)**

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | |
|:---|:---|
| Title of each class | Name of each exchange on which registered |
| Common Stock, $0.001 par value per share CELC | The Nasdaq Stock Market LLC |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

---

| | |
|:---|:---|
| **Item 2.02** | **Results of Operations and Financial Condition.** |

---

On November 12, 2025, Celcuity Inc. (the "Company") issued a press release regarding the Company's financial results for the third quarter ended September 30, 2025. A copy of the Company's press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.

The information in this Item 2.02, including the accompanying exhibit, is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section. The information in this Item 2.02 shall not be incorporated by referenced into any filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

---

| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.** |

---

&nbsp;&nbsp;&nbsp;&nbsp;**(d)** **Exhibits** 

99.1 [Press release dated November 12, 2025](ex99-1.htm) <br>104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: November 12, 2025

---

| | |
|:---|:---|
| **CELCUITY INC.** | **CELCUITY INC.** |
| By: | */s/ Brian F. Sullivan* |
|  | Brian F. Sullivan |
|  | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**Celcuity Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update**

---

| |
|:---|
| *Presented detailed efficacy and safety results from the PIK3CA wild-type ("WT") cohort of the Phase 3 VIKTORIA-1 clinical trial at a late breaking oral presentation at the 2025 European Society for Medical Oncology ("ESMO") Congress* |
| *Presented updated clinical results from the Phase 1b portion of a clinical trial evaluating gedatolisib in combination with Nubeqa® (darolutamide) in men with metastatic castration resistant prostate cancer ("mCRPC") at a poster session at ESMO* |
| *Completed enrollment of the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial and expect topline data to be available sometime in late Q1 2026 or during Q2 2026* |
| *Submission of a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for gedatolisib, based on data from the PIK3CA WT cohort, is on track to be completed during the fourth quarter of 2025* |
| *Management to host webcast and conference call today, November 12, 2025, at 4:30 p.m. ET* |

---

**MINNEAPOLIS, November 12, 2025** — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the third quarter ended September 30, 2025 and other recent business developments.

"We made significant clinical and regulatory progress in the third quarter," said Brian Sullivan, CEO and co-founder of Celcuity. "At the ESMO Congress, we presented potentially practice-changing safety and efficacy results for the gedatolisib regimens from the *PIK3CA* wild-type cohort of our Phase 3 VIKTORIA-1 trial at a late breaking oral presentation. We remain on track to submit the New Drug Application for gedatolisib later this year based on data from the *PIK3CA* wild-type cohort. The *PIK3CA* mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled with topline data expected in late Q1 2026 or during Q2 2026."

"There is an urgent need for more efficacious therapies than those currently available for patients with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor. With our strengthened balance sheet, and unprecedented efficacy results in this patient population, we are well positioned to bring gedatolisib to patients should we get FDA approval."

**Third Quarter 2025 Business Highlights and Other Recent Developments**

● The
 Company announced positive topline data for both primary endpoints of the *PIK3CA* WT cohort of the Phase 3 VIKTORIA-1 clinical
 trial that evaluated gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in patients with HR+, HER2- advanced
 breast cancer ("ABC") whose disease had progressed on or after prior treatment with a CDK4/6 inhibitor. Detailed safety
 and efficacy results were subsequently presented at a late breaking oral presentation at the 2025 ESMO Congress. The results demonstrate
 the potential for the gedatolisib regimens to be practice changing for patients with HR+, HER2- ABC.

---

| |
|:---|
| The gedatolisib-triplet (gedatolisib, fulvestrant, and palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant based on a hazard ratio ("HR") of 0.24. The median progression free survival ("PFS") was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months. |
| The gedatolisib doublet (gedatolisib and fulvestrant) reduced the risk of disease progression or death by 67% compared to fulvestrant based on a hazard ratio of 0.33. The median PFS was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months. |
| Clinical benefit of the gedatolisib regimens was consistent across patient subgroups. |
| The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events ("TRAEs"). The most common Grade 3 TRAEs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia (52.3%, 0%, and 0.8% of patients, respectively); stomatitis (19.2%, 12.3%, and 0% of patients, respectively); rash (4.6%, 5.4%, and 0% of patients, respectively); and hyperglycemia (2.3%, 2.3%, and 0% of patients, respectively). |
| Study treatment discontinuation due to TRAEs was reported in 2.3% of patients treated with the gedatolisib triplet and 3.1% of patients with the gedatolisib doublet. |
| The *PIK3CA* mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled with topline data expected sometime in late Q1 2026 or during Q2 2026. |

---

● Updated
 data from a Phase 1b study evaluating gedatolisib plus darolutamide in men with mCRPC was presented at a poster session at the 2025
 ESMO Congress.

---

| |
|:---|
| In this Phase 1b study, 38 patients with mCRPC were randomly assigned to receive 600 mg darolutamide twice daily combined with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib in Arm 2. |
| The six-month radiographic PFS ("rPFS") rate and median rPFS for patients from both arms combined was 67% and 9.1 months, respectively. For patients treated with 120 mg gedatolisib, the six-month rPFS rate was 74% and median rPFS was 9.5 months. For patients treated with 180 mg gedatolisib, the six-month rPFS rate was 61% and the median rPFS was 7.4 months. |
| The combination of gedatolisib and darolutamide was generally well tolerated in the trial with mostly low-grade TRAEs. No dose limiting toxicities were observed in either arm. The only Grade 3 TRAEs for patients from both arms combined included rash (5.3%), stomatitis (2.6%), and pruritus (2.6%); no Grade 3 hyperglycemia was reported. Additionally, no Grade 4 or 5 TRAEs were observed, and no patients discontinued study treatment due to a TRAE. |

---

● The
 FDA accepted the Company's request to submit an NDA for gedatolisib under the Real-Time Oncology Review ("RTOR")
 program based on data from the *PIK3CA* WT cohort of the Phase 3 VIKTORIA-1 clinical trial. The Company made its first NDA pre-submission
 in September 2025 and completion of the NDA submission is targeted for the fourth quarter of 2025.

● In
 July 2025, the first patient was dosed in VIKTORIA-2, a Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and
 fulvestrant as a first-line treatment for patients with HR+/HER2- ABC who are endocrine therapy resistant.

● In
 July 2025, the Company conducted a concurrent public offering of 2.750% convertible senior notes due 2031, common stock and pre-funded
 warrants. The net proceeds from the offerings were $287 million, after deducting underwriting discounts and commissions and the Company's
 offering expenses.

● In
 September 2025, the Company entered into an amendment to its existing senior secured term loan facility with an affiliate of Innovatus
 Capital Partners, LLC ("Innovatus"), and Oxford Finance LLC and certain of its affiliates (together, "Oxford").
 The amendment increases the total term loan facility size to $500 million, including $350 million in committed capital and up to
 $150 million at the mutual discretion of Celcuity and its lenders.

---

| | |
|:---|:---|
| ◌ | With the release of the topline data from the *PIK3CA* WT cohort of the VIKTORIA-1 Phase 3 clinical trial, Celcuity achieved the Term D milestone under the term loan facility and was eligible to draw an additional $30 million. In connection with the amendment, the $30.0 million Term D loan was disbursed and the Company received net proceeds of $27.8 million. |
| ◌ | The upsized facility strengthens Celcuity's ability to manage its capital structure efficiently while providing additional funding to support commercial launch preparations for gedatolisib and other strategic initiatives. |

---

● In
 the third quarter of 2025, investors exercised warrants generating cash proceeds of $12.8 million. The warrants were issued pursuant
 to a private placement that closed on December 9, 2022 and had an expiration date of 75 days from the release of the topline data
 from the *PIK3CA* WT cohort of the VICTORIA-1 Phase 3 clinical trial.

**Third Quarter 2025 Financial Results** 

Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2025, compared to the third quarter ended September 30, 2024.

Total operating expenses were $42.8 million for the third quarter of 2025, compared to $30.1 million for the third quarter of 2024.

Research and development ("R&D") expenses were $34.9 million for the third quarter of 2025, compared to $27.6 million for the prior-year period. Of the approximately $7.3 million increase in R&D expenses, $5.6 million was related to increased employee and consulting expenses, $3.2 million of which related to commercial headcount additions and other launch-related activities. The remaining $1.7 million increase was primarily related to activities supporting our ongoing clinical trials.

General and administrative ("G&A") expenses were $7.9 million for the third quarter of 2025, compared to $2.5 million for the prior-year period. Of the approximately $5.4 million increase in general and administrative expenses, $4.9 million was related to increased employee and consulting expenses. Of this $4.9 million increase, $4.0 million was related to non-cash, stock-based compensation. The remaining $0.5 million of the $5.4 million increase was primarily related to professional fees, expanding infrastructure and other administrative expenses.

Net loss for the third quarter of 2025 was $43.8 million, or $0.92 loss per share, compared to a net loss of $29.8 million, or $0.70 loss per share, for the third quarter of 2024. Non-GAAP adjusted net loss for the third quarter of 2025 was $37.2 million, or $0.78 loss per share, compared to non-GAAP adjusted net loss of $27.6 million, or $0.65 loss per share, for the third quarter of 2024. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity's cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States ("GAAP") to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the third quarter of 2025 was $44.8 million, compared to $20.6 million for the third quarter of 2024.

At September 30, 2025, Celcuity reported cash, cash equivalents and short-term investments of $455.0 million. We expect cash, cash equivalents, investments and drawdowns on our debt facility to fund operations through 2027.

**Webcast and Conference Call Information** 

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the third quarter 2025 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: <u>https://viavid.webcasts.com/starthere.jsp?ei=1736070&tp_key=9d6c00e337</u>. A replay of the webcast will be available on the Celcuity website following the live event.

**About Celcuity**

Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC has completed enrollment and the company has reported detailed results for the *PIK3CA* WT cohort, and has completed enrollment of patients for the *PIK3CA* mutant cohort. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC is currently enrolling patients. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. More detailed information about Celcuity's active clinical trials can be found at <u>ClinicalTrials.gov</u> . Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at <u>www.celcuity.com</u> . Follow us on <u>LinkedIn</u> and <u>X</u> .

**Forward-Looking Statements**

This press release contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of clinical trial data; the market opportunity for gedatolisib; the ability of our data to support the filing of an NDA with the FDA and the expected timing of such filing; our expectations regarding the timing of and our ability to obtain FDA approval to commercialize gedatolisib; our strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib; our anticipated use of cash; and the strength of our balance sheet. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "confidence," "encouraged," "potential," "plan," "targets," "likely," "may," "will," "would," "should" and "could," and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that our clinical results are based on an ongoing analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in our clinical trials; unforeseen delays in our planned NDA for gedatolisib; our ability to obtain and maintain regulatory approvals to commercialize gedatolisib, and the market acceptance of gedatolisib; the development of therapies and tools competitive with gedatolisib; and our ability to access capital upon favorable terms. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

<u>View source version of release on GlobeNewswire.com</u>

**Contacts:**

Celcuity Inc.

Brian Sullivan, bsullivan@celcuity.com

Vicky Hahne, vhahne@celcuity.com

(763) 392-0123

ICR Healthcare

Patti Bank, patti.bank@icrhealthcare.com

(415) 513-1284

**Celcuity Inc.** 

**Condensed Balance Sheets** 

*(in thousands)* 

---

| | | |
|:---|:---|:---|
|  | **September 30, 2025** | **December 31, 2024** |
|  | **(unaudited)** | |
| **Assets** |  |  |
| **Current Assets:** |  |  |
| &nbsp;&nbsp;&nbsp;Cash and cash equivalents | $74252 | $22515 |
| &nbsp;&nbsp;&nbsp;Investments | 380726 | 212589 |
| &nbsp;&nbsp;&nbsp;Other current assets | 20519 | 9467 |
| **Total current assets** | 475497 | 244571 |
| Property and equipment, net | 417 | 336 |
| &nbsp;&nbsp;&nbsp;Operating lease right-of-use assets | 90 | 216 |
| **Total Assets** | $**476004** | $**245123** |
| **Liabilities and Stockholders' Equity:** |  |  |
| **Current Liabilities:** |  |  |
| &nbsp;&nbsp;&nbsp;Accounts payable | $11418 | $9366 |
| &nbsp;&nbsp;&nbsp;Operating lease liabilities | 96 | 172 |
| &nbsp;&nbsp;&nbsp;Accrued expenses | 27278 | 22185 |
| **Total current liabilities** | 38792 | 31723 |
| Operating lease liabilities |  | 54 |
| Note payable, non-current | 125166 | 97727 |
| Convertible Debt | 195083 | - |
| **Total Liabilities** | 359041 | 129504 |
| **Total Stockholders' Equity** | 116963 | 115619 |
| **Total Liabilities and Stockholders' Equity** | $**476004** | $**245123** |

---

**Celcuity Inc.** 

**Condensed Statements of Operations** 

**(unaudited)** 

*(in thousands, except share and per share amounts)* 

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended**<br>**September 30,** | **Three Months Ended**<br>**September 30,** | **Nine Months Ended**<br>**September 30,** | **Nine Months Ended**<br>**September 30,** |
|  | **2025** | **2024** | **2025** | **2024** |
| **Operating expenses:** |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Research and development | $34915 | $27588 | $107364 | $70732 |
| &nbsp;&nbsp;&nbsp;General and administrative | 7934 | 2472 | 15627 | 6105 |
| Total operating expenses | 42849 | 30060 | 122991 | 76837 |
| Loss from operations | (42849) | (30060) | (122991) | (76837) |
| Other (expense) income |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Interest expense | (4595) | (3344) | (10982) | (7005) |
| &nbsp;&nbsp;&nbsp;Interest income | 3640 | 3612 | 7904 | 8716 |
| Other (expense) income, net | (955) | 268 | (3078) | 1711 |
| **Net loss before income taxes** | **(43804)** | **(29792)** | **(126069)** | **(75126)** |
| Income tax benefits | - | - | - | - |
| **Net loss** | $**(43804)** | $**(29792)** | $**(126069)** | $**(75126)** |
| Net loss per share, basic and diluted | $(0.92) | $(0.70) | $(2.81) | $(1.96) |
| Weighted average common shares outstanding, basic and diluted | 47589731 | 42793047 | 44785236 | 38299548 |

---

**Cautionary Statement Regarding Non-GAAP Financial Measures**

This press release contains references to non-GAAP adjusted net loss and non-GAAP adjusted net loss per share. Management believes these non-GAAP financial measures are useful supplemental measures for planning, monitoring, and evaluating operational performance as they exclude stock-based compensation expense, non-cash interest expense, and non-cash interest income from net loss and net loss per share. Management excludes these items because they do not impact Celcuity's cash position, which management believes better enables Celcuity to focus on cash used in operations. However, non-GAAP adjusted net loss and non-GAAP adjusted net loss per share are not recognized measures under GAAP and do not have a standardized meaning prescribed by GAAP. As a result, management's method of calculating non-GAAP adjusted net loss and non-GAAP adjusted net loss per share may differ materially from the method used by other companies. Therefore, non-GAAP adjusted net loss and non-GAAP adjusted net loss per share may not be comparable to similarly titled measures presented by other companies. Investors are cautioned that non-GAAP adjusted net loss and non-GAAP adjusted net loss per share should not be construed as alternatives to net loss, net loss per share or other statements of operations data (which are determined in accordance with GAAP) as an indicator of Celcuity's performance or as a measure of liquidity and cash flows.<br>

**Celcuity Inc.**

**Reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss and**

**GAAP Net Loss Per Share to Non-GAAP Adjusted Net Loss Per Share**

*(in thousands, except share and per share amounts)*

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended<br> September 30,** | **Three Months Ended<br> September 30,** | **Nine Months Ended<br> September 30,** | **Nine Months Ended<br> September 30,** |
|  | **2025** | **2024** | **2025** | **2024** |
| GAAP net loss | $(43804) | $(29792) | $(126069) | $(75126) |
| &nbsp;&nbsp;&nbsp;Adjustments: |  |  |  |  |
| Stock-based compensation |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Research and development <sup>(1)</sup> | 2057 | 1190 | 5285 | 3001 |
| &nbsp;&nbsp;&nbsp;General and administrative <sup>(2)</sup> | 4722 | 741 | 6642 | 1672 |
| Non-cash interest expense <sup>(3)</sup> | 1050 | 730 | 2639 | 1891 |
| Non-cash interest income <sup>(4)</sup> | (1180) | (474) | (840) | (1113) |
| **Non-GAAP adjusted net loss** | $**(37155)** | $**(27605)** | $**(112343)** | $**(69675)** |
| GAAP net loss per share - basic and diluted | $(0.92) | $(0.70) | $(2.81) | $(1.96) |
| Adjustment to net loss: |  |  |  |  |
| Stock - based compensation |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Research and development | 0.04 | 0.03 | 0.12 | 0.08 |
| &nbsp;&nbsp;&nbsp;General and administrative | 0.10 | 0.02 | 0.15 | 0.04 |
| Non-cash interest expense | 0.02 | 0.01 | 0.06 | 0.05 |
| Non-cash interest income | (0.02) | (0.01) | (0.02) | (0.03) |
| **Non-GAAP adjusted net loss per share** | $**(0.78)** | $**(0.65)** | $**(2.50)** | $**(1.82)** |
| Weighted average common shares outstanding, basic and diluted | 47589731 | 42793047 | 44785236 | 38299548 |

---

(1) To
 reflect a non-cash charge to operating expense for Research and Development stock-based compensation.

(2) To
 reflect a non-cash charge to operating expense for General and Administrative stock-based compensation.

(3) To
 reflect a non-cash charge to other expense for amortization of debt issuance and discount costs and PIK interest related to the issuance
 of a note payable.

(4) To
 reflect a non-cash adjustment to other income for accretion on investments.