SEC 8-K filings with transcript text
Aug 13, 2026
2 kynb-ex99_1.htm
Exhibit 99.1
Kyntra Bio Reports Second Quarter 2026 Financial Results and Provides Business Update
• 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, August 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.
o 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.
o 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 demonstrate
May 11, 2026
2 kynb-ex99_1.htm
Exhibit 99.1
Kyntra Bio Reports First Quarter 2026 Financial Results and Provides Business Update
• 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 progressing well with the interim analysis anticipated in 4Q 2026
• Positive results from the investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with mCRPC were presented at ASCO GU in February 2026, further validating key Phase 2 monotherapy design elements
• Pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high transfusion burden is being finalized following feedback from the U.S. Food and Drug Administration (FDA)
• Cash, cash equivalents, investments, and accounts receivable of $100.3 million, providing cash runway into 2028
• Kyntra Bio to host conference call and webcast presentation today at 5:00 PM ET
SAN FRANCISCO, May 11, 2026 (GLOBE NEWSWIRE) -- Kyntra Bio (Nasdaq: KYNB) today reported financial results for the first quarter 2026 and provided an update on the company’s recent developments.
“In the first quarter, we continued to make steady progress across our pipeline. We are encouraged by the pace of enrollment in our Phase 2 trial of FG-3246 in patients with mCRPC and are on track for the interim analysis in the fourth quarter of 2026. We remain confident in the potential of FG-3246 to deliver competitive progression free survival results in the Phase 2 monotherapy trial,” commented Thane Wettig, Chief Executive Officer of Kyntra Bio. “In addition, following FDA feedback, we are finalizing the protocol for the pivotal Phase 3 trial of roxadustat for the treatment of lower-risk MDS, and anticipate trial initiation in the second half of 2026.”
Key Highlights of First Quarter, 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 fourth quarter 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
o In biomarker unselected patients with androgen receptor pathway inhibitor (ARPI)-treated, taxane-naïve mCRPC, the combination of FG-3246 and enzalutamide led to a median radiographic progression free survival (rPFS) of 7.0 months in the overall study cohort, and a median rPFS of 10.1 months in patients who progressed on only one prior ARPI.
o 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.
o Combination therapy had a similar safety and exposure profile to the previous FG-3246 Phase 1 monotherapy trial.
o 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
• Pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden is being finalized based on feedback received from the FDA
• 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 second half of 2026
Financial
• Total revenue from continuing operations for the first quarter of 2026 was $3.7 million, as compared to $2.7 million for the first quarter of 2025.
• Net loss from continuing operations for the first quarter of 2026 was $15.1 million, or $3.74 net loss per basic and diluted share, compared to a net loss of $16.8 million, or $4.15 net loss per basic and diluted share, one year ago.
• As of March 31, 2026, Kyntra Bio reported $100.3 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 ant
Mar 16, 2026
2 kynb-ex99_1.htm
Exhibit 99.1
Kyntra Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
• 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
o 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
o 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
o Combination therapy had a similar safety and exposure profile to the previous FG-3246 Phase 1 monotherapy trial
o 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 Presentati
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