-- 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
-- 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
-- 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
-- Cash, cash equivalents, investments, and accounts receivable of $109.4
million, providing cash runway into 2028
-- 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)
-- 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
-- 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
-- FG-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
-- Higher tumor uptake of FG-3180 was numerically associated with
PSA50 response (nominal p=0.053), highlighting its potential as a
biomarker for patient selection
-- Combination therapy had a similar safety and exposure profile to
the previous FG-3246 Phase 1 monotherapy trial
-- Results 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
-- Granted Orphan Drug Designation from the FDA for the treatment of MDS.
-- 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.
-- 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.
Financial
-- 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.
-- 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.
-- 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.
-- 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.
-- As of December 31, 2025, Kyntra Bio reported $109.4 million in cash, cash
equivalents, investments, and accounts receivable.
-- 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 (89) Zr 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 ( $(R)$ , EVRENZO(TM)) 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.
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.
Condensed Consolidated Balance Sheets
(In thousands)
December 31, 2025 December 31, 2024
------------------- -------------------
(Unaudited) (1)
Assets
Current assets:
Cash and cash equivalents $ 47,872 $ 50,482
Short-term investments 41,106 --
Accounts receivable, net 216 481
Inventory 3,743 3,155
Prepaid expenses and other
current assets 6,136 31,542
Current assets held for
sale -- 110,849
--- -------------- ---------------
Total current assets 99,073 196,509
Long-term investments 20,160 --
Other assets 361 1,405
Long-term assets held for
sale -- 16,611
--- -------------- ---------------
Total assets $ 119,594 $ 214,525
=== ============== ===============
Liabilities, stockholders'
equity and non-controlling
interests
Current liabilities:
Accounts payable $ 3,745 $ 5,064
Accrued and other
liabilities 20,183 62,035
Deferred revenue 5,314 27,290
Current liabilities held
for sale -- 38,917
--- -------------- ---------------
Total current
liabilities 29,242 133,306
Product development
obligations 19,560 17,012
Deferred revenue, net of
current 255 114,708
Senior secured term loan
facilities, non-current -- 73,092
Liability related to sale of
future revenues,
non-current 65,980 58,864
Other long-term liabilities 82 822
Long-term liabilities held
for sale -- 356
--- -------------- ---------------
Total liabilities 115,119 398,160
Redeemable non-controlling
interests 21,480 21,480
Total stockholders' deficit
attributable to FibroGen (30,038) (225,602)
Nonredeemable
non-controlling interests 13,033 20,487
--- -------------- ---------------
Total deficit (17,005) (205,115)
--- -------------- ---------------
Total liabilities,
redeemable non-controlling
interests and deficit $ 119,594 $ 214,525
=== ============== ===============
(1) The condensed consolidated balance sheet amounts at December 31, 2024 are derived from audited financial statements.
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
Three Months Ended Years Ended
December 31, December 31,
------------------ -------------------------
2025 2024 2025 2024
-------- ------- ------------- ---------
(Unaudited) (Unaudited) (1)
Revenue:
Development and
other revenue $ 197 $ 416 592 1,948
Drug product
revenue, net 1,081 2,720 5,848 27,673
------- ------ --------- --------
Total revenue 1,278 3,136 6,440 29,621
Operating costs
and expenses:
Cost of goods
sold 278 (5,845) 556 15,561
Research and
development 7,268 6,870 23,517 95,692
Selling, general
and
administrative 7,251 8,345 27,709 49,330
Restructuring
charge (7) 900 553 19,454
------- ------ --------- --------
Total
operating
costs and
expenses 14,790 10,270 52,335 180,037
------- ------ --------- --------
Loss from
operations (13,512) (7,134) (45,895) (150,416)
Interest and
other, net:
Interest expense (2,413) (2,217) (8,759) (8,247)
Loss on debt
extinguishments -- -- (6,583) --
Interest income
and other
income
(expenses),
net 1,316 688 2,943 5,296
------- ------ --------- --------
Total interest
and other,
net (1,097) (1,529) (12,399) (2,951)
------- ------ --------- --------
Loss from
continuing
operations before
income taxes (14,609) (8,663) (58,294) (153,367)
Provision for
(benefit from)
income taxes -- 2 (90) (269)
Loss from
continuing
operations (14,609) (8,665) (58,204) (153,098)
Income from
discontinued
operations, net
of tax 389 26,647 241,656 105,519
------- ------ --------- --------
Net income (loss) $(14,220) $17,982 $ 183,452 $ (47,579)
======= ====== ========= ========
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
calculate net
income (loss) per
share - basic and
diluted 4,046 4,033 4,043 4,002
(1) The condensed consolidated statement of operations amounts for the year ended December 31, 2024 are derived from audited financial statements.
For Investor Inquiries:
David DeLucia, CFA
Senior Vice President and Chief Financial Officer
ir@kyntrabio.com
(END) Dow Jones Newswires
March 16, 2026 16:02 ET (20:02 GMT)