-- 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), continues enrolling with interim analysis on
track for 4Q 2026
-- Phase 3 protocol of roxadustat for the treatment of anemia in patients
with lower-risk myelodysplastic syndromes (LR-MDS) and high transfusion
burden $(HTB)$ has been finalized with the goal to initiate the
registrational study in 4Q 2026
-- Additional data from the Phase 3 MATTERHORN study were presented at the
European Hematology Association (EHA) Congress 2026, highlighting
improvements in transfusion independence in patients with HTB and
regardless of ring sideroblast status
-- Cash, cash equivalents, investments, and accounts receivable of $95.7
million as of June 30, 2026
-- Kyntra Bio to host conference call and webcast presentation today at 5:00
PM ET
SAN FRANCISCO, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Kyntra Bio (Nasdaq: KYNB) today reported financial results for the second quarter 2026 and provided an update on the company's recent developments.
"We continue to make progress across our oncology and rare disease portfolio and remain laser-focused on advancing toward our goal of initiating a pivotal Phase 3 trial of roxadustat in LR-MDS in the fourth quarter of this year and conducting an interim analysis of the Phase 2 trial of FG-3246 in mCRPC, also in the fourth quarter of this year," said Thane Wettig, Chief Executive Officer of Kyntra Bio. "We believe we have the substrate that will enable us to create significant value for patients and stakeholders as we advance our pipeline and look forward to providing additional updates in the coming months."
Key Highlights of Second Quarter, Recent Developments, and Upcoming Milestones
FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent)
-- Enrollment in the Phase 2 monotherapy trial of FG-3246, a potential
first-in-class ADC targeting CD46 in mCRPC continues; interim analysis is
on track for the fourth quarter of 2026.
Roxadustat
-- Pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia
in patients with LR-MDS and high transfusion burden (HTB) has been
finalized.
-- Additional data from the Phase 3 MATTERHORN study were presented at the
European Hematology Association (EHA) Congress 2026.
-- In a post hoc analysis of the Phase 3 MATTERHORN study, patients
treated with roxadustat showed a clinically meaningful improvement
in transfusion independence (TI) in patients with LR-MDS and HTB
compared to placebo.
-- Similar rates of TI for patients treated with roxadustat were
observed in both ring sideroblast positive (RS+) and ring
sideroblast negative (RS-) disease.
-- Company continues to explore the opportunity to develop roxadustat
internally or with a strategic partner, with the goal of initiating the
Phase 3 trial in the fourth quarter of 2026.
Financial
-- Total revenue from continuing operations for the second quarter of 2026
was $(1.5) million, as compared to $1.3 million for the second quarter of
2025.
-- Net income from continuing operations for the second quarter of 2026 was
$12.0 million, or $2.96 net income per basic and diluted share, compared
to a net loss of $13.7 million, or $3.38 net loss per basic and diluted
share, one year ago.
-- As of June 30, 2026, Kyntra Bio reported $95.7 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 tracer. 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)
June 30, 2026 December 31, 2025
--------------- ---------------------
(Unaudited) (1)
Assets
Current assets:
Cash and cash equivalents $ 50,644 $ 47,872
Short-term investments 40,674 41,106
Accounts receivable, net 347 216
Inventory 3,384 3,743
Prepaid expenses and other
current assets 1,776 6,136
Total current assets 96,825 99,073
Long-term investments 4,012 20,160
Other assets 241 361
Total assets $ 101,078 $ 119,594
=========== ==============
Liabilities, stockholders' equity
and non-controlling interests
Current liabilities:
Accounts payable $ 7,510 $ 3,745
Accrued and other liabilities 23,112 20,183
Deferred revenue 5,418 5,314
Total current liabilities 36,040 29,242
Product development obligations -- 19,560
Deferred revenue, net of current 2,620 255
Liability related to sale of
future revenues, non-current 70,495 65,980
Other long-term liabilities 67 82
Total liabilities 109,222 115,119
Redeemable non-controlling
interests 21,480 21,480
Total stockholders' deficit
attributable to Kyntra Bio (30,144) (30,038)
Nonredeemable non-controlling
interests 520 13,033
----------- --------------
Total deficit (29,624) (17,005)
----------- --------------
Total liabilities, redeemable
non-controlling interests and
deficit $ 101,078 $ 119,594
=========== ==============
(1) The condensed consolidated balance sheet amounts at December 31, 2025 are derived from audited financial statements.
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
Three Months Ended Six Months Ended
June 30, June 30,
------------------- -------------------
2026 2025 2026 2025
-------- -------- -------- --------
(Unaudited)
Revenue:
Development and
other revenue $ 103 $ 133 349 277
Drug product
revenue, net (1,577) 1,215 1,915 3,811
------- ------- ------- -------
Total revenue (1,474) 1,348 2,264 4,088
Operating costs and
expenses:
Cost of goods
sold 2 85 4,108 337
Research and
development 6,821 5,865 14,387 15,040
Selling, general
and
administrative 9,266 7,057 15,128 15,164
Restructuring
charge 11 393 33 519
------- ------- ------- -------
Total
operating
costs and
expenses 16,100 13,400 33,656 31,060
------- ------- ------- -------
Loss from
operations (17,574) (12,052) (31,392) (26,972)
Interest and other,
net:
Interest expense (2,368) (2,009) (4,795) (4,265)
Gain on
deconsolidation
of subsidiary 30,940 -- 30,940 --
Interest income
and other
income
(expenses),
net 975 286 2,088 698
------- ------- ------- -------
Total
interest and
other, net 29,547 (1,723) 28,233 (3,567)
------- ------- ------- -------
Income (loss) from
continuing
operations before
income taxes 11,973 (13,775) (3,159) (30,539)
Benefit from income
taxes (1) (92) (1) (90)
Income (loss) from
continuing
operations 11,974 (13,683) (3,158) (30,449)
Income (loss) from
discontinued
operations, net of
tax -- 6,080 (66) 27,485
------- ------- ------- -------
Net income (loss) $ 11,974 $ (7,603) $ (3,224) $ (2,964)
======= ======= ======= =======
Income (loss) from
continuing
operations per
share - basic and
diluted $ 2.96 $ (3.38) $ (0.78) $ (7.54)
Income (loss) from
discontinued
operations per
share - basic and
diluted -- 1.50 (0.02) 6.81
------- ------- ------- -------
Net income (loss)
per share - basic
and diluted $ 2.96 $ (1.88) $ (0.80) $ (0.73)
======= ======= ======= =======
Weighted average
number of common
shares used to
calculate net
income (loss) per
share - basic and
diluted 4,048 4,042 4,048 4,040
For Investor Inquiries:
David DeLucia, CFA
Senior Vice President and Chief Financial Officer
ir@kyntrabio.com
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