# EDGAR Filing Document

**Accession Number:** 0000921299
**File Stem:** 0001193125-26-108324
**Filing Date:** 2026-3
**Character Count:** 21116
**Document Hash:** 3e2052d5ba3f840d2100ff7ba61e7da5
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-26-108324.hdr.sgml**: 20260316

**ACCESSION NUMBER**: 0001193125-26-108324

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 10

**CONFORMED PERIOD OF REPORT**: 20260316

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

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260316

**DATE AS OF CHANGE**: 20260316

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** KYNTRA BIO, INC.
- **CENTRAL INDEX KEY:** 0000921299
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 770357827
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36740
- **FILM NUMBER:** 26756643

**BUSINESS ADDRESS:**
- **STREET 1:** 350 BAY STREET
- **STREET 2:** SUITE 100 #6009
- **CITY:** SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94133
- **BUSINESS PHONE:** 415-978-1200

**MAIL ADDRESS:**
- **STREET 1:** 350 BAY STREET
- **STREET 2:** SUITE 100 #6009
- **CITY:** SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94133

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** FIBROGEN INC
- **DATE OF NAME CHANGE:** 19940405

?xml version='1.0' encoding='ASCII'? 8-K

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549**

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## FORM 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** March 16, 2026<br>

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KYNTRA BIO, INC.

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

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| | | |
|:---|:---|:---|
| Delaware | 001-36740 | 77-0357827 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 350 Bay Street<br>Suite 100 #6009  |  |  |
| San Francisco**,** California |  | 94133 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** 415 978-1200 <br>

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

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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:**

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| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Common Stock, $0.01 par value | KYNB | The Nasdaq Global Select Market |

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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. ☐

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## Item 2.02 Results of Operations and Financial Condition.
On March 16, 2026, Kyntra Bio, Inc. ("Kyntra Bio") issued a press release announcing financial results for the quarter and year ended December 31, 2025. A copy of such 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 Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02, in Exhibit 99.1 shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Kyntra Bio, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

## Item 9.01 Financial Statements and Exhibits.

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| | | |
|:---|:---|:---|
| (d) | Exhibits | Exhibits |
| **Exhibit No.** | **Exhibit No.** | **Description** |
| 99.1 | 99.1 | [<u>Press Release dated March 16, 2026</u>](kynb-ex99_1.htm) |
| 104 | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

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**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.

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| | | | |
|:---|:---|:---|:---|
|  |  |  | KYNTRA BIO, INC. |
| Date: | March 16, 2026 | By:  | /s/ David DeLucia |
|  |  |  | David DeLucia<br>Senior Vice President and Chief Financial Officer |

---

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## Exhibit 99.1

**Exhibit 99.1**

**Kyntra Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•*Phase 2 monotherapy trial of FG-3246, a potential first-in-class antibody drug conjugate (ADC) targeting CD46, in metastatic castration-resistant prostate cancer (mCRPC) is actively enrolling and remains on track for interim analysis in 2H 2026*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•*Positive results from the investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with mCRPC, further validating key Phase 2 monotherapy design elements, were presented at the 2026 ASCO GU*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•*Submitted the pivotal Phase 3 clinical trial protocol for roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high transfusion burden to the U.S. Food and Drug Administration*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•*Cash, cash equivalents, investments, and accounts receivable of $109.4 million, providing cash runway into 2028*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•*Kyntra Bio to host conference call and webcast presentation today at 5:00 PM ET*

SAN FRANCISCO, March 16, 2026 (GLOBE NEWSWIRE) -- Kyntra Bio (Nasdaq: KYNB) today reported financial results for the fourth quarter and full year 2025 and provided an update on the company's recent developments.

"The encouraging results from the investigator-sponsored combination trial of FG-3246 with enzalutamide provide us with valuable insights and reinforce key design elements in our Phase 2 monotherapy study," said Thane Wettig, Chief Executive Officer of Kyntra Bio. "Our Phase 2 monotherapy trial of FG-3246 is progressing as planned, with interim results expected in the second half of 2026. Additionally, we have submitted the Phase 3 trial protocol for roxadustat for the treatment of anemia in patients with LR-MDS and expect feedback from the FDA shortly, with the intention to start a Phase 3 trial in the second half of 2026. With our successful transformation in 2025, we are well-positioned to execute our strategic plan in 2026 and anticipate an exciting year ahead."

**Key Highlights of Fourth Quarter 2025, Recent Developments, and Upcoming Milestones**

**FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent)**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Phase 2 monotherapy trial of FG-3246, a potential first-in-class ADC targeting CD46, in mCRPC is actively enrolling and remains on track for interim analysis in the second half of 2026

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Topline results from the investigator-sponsored Phase 1b/2 study, conducted by UCSF, of FG-3246 in combination with enzalutamide in patients with mCRPC were presented at ASCO GU 2026

oFG-3246 and enzalutamide combination therapy, in biomarker unselected patients with androgen receptor pathway inhibitor (ARPI)-treated, taxane-naïve mCRPC, led to a median radiographic progression free survival (rPFS) of 7.0 months in the overall study cohort, with median rPFS of 10.1 months observed in patients who progressed on only one prior ARPI

oHigher tumor uptake of FG-3180 was numerically associated with PSA50 response (nominal p=0.053), highlighting its potential as a biomarker for patient selection

oCombination therapy had a similar safety and exposure profile to the previous FG-3246 Phase 1 monotherapy trial

oResults further validate key FG-3246 Phase 2 monotherapy design elements, most importantly the inclusion of patients who have progressed on only one prior ARPI and integration of baseline FG-3180 PET for all enrolled patients

**Roxadustat**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Granted Orphan Drug Designation from the FDA for the treatment of MDS.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Submitted the pivotal Phase 3 clinical trial protocol for roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden to the U.S. Food and Drug Administration.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Company is currently exploring the opportunity to develop roxadustat internally or with a strategic partner, with the goal of starting the Phase 3 trial in the second half of 2026.

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**Financial**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Total revenue from continuing operations for the fourth quarter of 2025 was $1.3 million, as compared to $3.1 million for the fourth quarter of 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Total revenue from continuing operations for the full year 2025 was $6.4 million, as compared to $29.6 million for the full year 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Net loss from continuing operations for the fourth quarter of 2025 was $14.6 million, or $3.61 net loss per basic and diluted share, compared to a net loss of $8.7 million, or $2.15 net loss per basic and diluted share, one year ago.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Net loss from continuing operations for the full year 2025 was $58.2 million, or $14.40 net loss per basic and diluted share, compared to a net loss of $153.1 million, or $38.26 net loss per basic and diluted share, for the full year 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•As of December 31, 2025, Kyntra Bio reported $109.4 million in cash, cash equivalents, investments, and accounts receivable.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The Company expects its cash, cash equivalents, investments, and accounts receivable to be sufficient to fund operating plans into 2028.

**Conference Call and Webcast Presentation**

Kyntra Bio management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on Kyntra Bio's website.

**About FG-3246 and FG-3180**

FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by Kyntra Bio for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3180 is a companion diagnostic PET imaging agent, using the same CD46-targeting antibody together with an 89Zr tracker. To date, FG-3180 demonstrated specific uptake in CD46 positive tumors and is currently being evaluated as a biomarker for its potential to inform patient selection.

**About Roxadustat**

Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin.

Roxadustat is approved in Europe, Japan, China, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Kyntra Bio has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and Kyntra Bio are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

**About Kyntra Bio** 

Kyntra Bio is a biopharmaceutical company focused on development of novel therapies in oncology and rare disease. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in Europe, Japan, China, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate the development plan for the Phase 3 trial of roxadustat in anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46, is in Phase 2 development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.kyntrabio.com.

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**Forward-Looking Statements** 

This release contains forward-looking statements regarding Kyntra Bio's strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of Kyntra Bio products and product candidates, statements under the caption "Recent Highlights and Upcoming Milestones", statements about regulatory interactions, statements regarding cash, such as the expectation that cash, cash equivalents and accounts receivable will be sufficient to fund Kyntra Bio's operating plans into 2028, and statements about Kyntra Bio's plans and objectives. These forward-looking statements are typically identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Kyntra Bio's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in Kyntra Bio's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Kyntra Bio undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

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**Condensed Consolidated Balance Sheets**

(In thousands)

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| | | |
|:---|:---|:---|
|  | **December 31, 2025** | **December 31, 2024** |
|  | **(Unaudited)** | **(1)** |
| **Assets** |  |  |
| Current assets: |  |  |
| &nbsp;&nbsp;Cash and cash equivalents | $47872 | $50482 |
| &nbsp;&nbsp;Short-term investments | 41106 |  |
| &nbsp;&nbsp;Accounts receivable, net | 216 | 481 |
| &nbsp;&nbsp;Inventory | 3743 | 3155 |
| &nbsp;&nbsp;Prepaid expenses and other current assets | 6136 | 31542 |
| &nbsp;&nbsp;Current assets held for sale |  | 110849 |
| &nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 99073 | 196509 |
| Long-term investments | 20160 |  |
| Other assets | 361 | 1405 |
| Long-term assets held for sale |  | 16611 |
| &nbsp;&nbsp;&nbsp;&nbsp;**Total assets** | $119594 | $214525 |
| **Liabilities, stockholders' equity and non-controlling interests** |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;Accounts payable | $3745 | $5064 |
| &nbsp;&nbsp;Accrued and other liabilities | 20183 | 62035 |
| &nbsp;&nbsp;Deferred revenue | 5314 | 27290 |
| &nbsp;&nbsp;Current liabilities held for sale |  | 38917 |
| &nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 29242 | 133306 |
| Product development obligations | 19560 | 17012 |
| Deferred revenue, net of current | 255 | 114708 |
| Senior secured term loan facilities, non-current |  | 73092 |
| Liability related to sale of future revenues, non-current | 65980 | 58864 |
| Other long-term liabilities | 82 | 822 |
| Long-term liabilities held for sale |  | 356 |
| &nbsp;&nbsp;&nbsp;&nbsp;Total liabilities | 115119 | 398160 |
| Redeemable non-controlling interests | 21480 | 21480 |
| Total stockholders' deficit attributable to Kyntra Bio | (30038) | (225602) |
| Nonredeemable non-controlling interests | 13033 | 20487 |
| Total deficit | (17005) | (205115) |
| **Total liabilities, redeemable non-controlling interests and deficit** | $119594 | $214525 |

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)The condensed consolidated balance sheet amounts at December 31, 2024 are derived from audited financial statements.

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**Condensed Consolidated Statements of Operations**

(In thousands, except per share data)

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended December 31,** | **Three Months Ended December 31,** | **Years Ended December 31,** | **Years Ended December 31,** |
|  | **2025** | **2024** | **2025** | **2024** |
|  | **(Unaudited)** | **(Unaudited)** | **(Unaudited)** | **(1)** |
| **Revenue:** |  |  |  |  |
| &nbsp;&nbsp;Development and other revenue | $197 | $416 | 592 | 1948 |
| &nbsp;&nbsp;Drug product revenue, net | 1081 | 2720 | 5848 | 27673 |
| &nbsp;&nbsp;&nbsp;&nbsp;Total revenue | 1278 | 3136 | 6440 | 29621 |
| **Operating costs and expenses:** |  |  |  |  |
| &nbsp;&nbsp;Cost of goods sold | 278 | (5845) | 556 | 15561 |
| &nbsp;&nbsp;Research and development | 7268 | 6870 | 23517 | 95692 |
| &nbsp;&nbsp;Selling, general and administrative | 7251 | 8345 | 27709 | 49330 |
| &nbsp;&nbsp;Restructuring charge | (7) | 900 | 553 | 19454 |
| &nbsp;&nbsp;&nbsp;&nbsp;Total operating costs and expenses | 14790 | 10270 | 52335 | 180037 |
| **Loss from operations** | (13512) | (7134) | (45895) | (150416) |
| **Interest and other, net:** |  |  |  |  |
| &nbsp;&nbsp;Interest expense | (2413) | (2217) | (8759) | (8247) |
| &nbsp;&nbsp;Loss on debt extinguishments |  |  | (6583) |  |
| &nbsp;&nbsp;Interest income and other income (expenses), net | 1316 | 688 | 2943 | 5296 |
| &nbsp;&nbsp;&nbsp;&nbsp;Total interest and other, net | (1097) | (1529) | (12399) | (2951) |
| **Loss from continuing operations before income taxes** | (14609) | (8663) | (58294) | (153367) |
| &nbsp;&nbsp;Provision for (benefit from) income taxes |  | 2 | (90) | (269) |
| **Loss from continuing operations** | (14609) | (8665) | (58204) | (153098) |
| Income from discontinued operations, net of tax | 389 | 26647 | 241656 | 105519 |
| **Net income (loss)** | $(14220) | $17982 | $183452 | $(47579) |
| Loss from continuing operations per share - basic and diluted | $(3.61) | $(2.15) | $(14.40) | $(38.26) |
| Income from discontinued operations per share - basic and diluted | 0.10 | 6.61 | 59.77 | 26.37 |
| **Net income (loss) per share - basic and diluted** | $(3.51) | $4.46 | $45.37 | $(11.89) |
| Weighted average number of common shares used to <br>&nbsp;&nbsp;&nbsp;&nbsp;calculate net income (loss) per share - basic and diluted | 4046 | 4033 | 4043 | 4002 |

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)The condensed consolidated statement of operations amounts for the year ended December 31, 2024 are derived from audited financial statements.

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**For Investor Inquiries:**

David DeLucia, CFA

Senior Vice President and Chief Financial Officer

ir@kyntrabio.com

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