LUND, SWEDEN / ACCESS Newswire / February 27, 2025 / BioInvent International (STO:BINV) "2024 was a year with several exciting developments reported from across our broad portfolio of clinical programs. We now have two Phase 2 and four Phase 1 trials running in our six clinical programs leveraging the TNFR2 and FcyRIIB targets. Throughout the year, we pursued building our business by expanding our management team and signing important clinical collaboration and supply agreements with key partners." - Martin Welschof CEO of BioInvent.
EVENTS IN THE FOURTH QUARTER
First patient enrolled in Phase 1b/2a study of the company's second anti-FcyRIIB antibody, BI-1607, in combination with ipilimumab and KEYTRUDA® (pembrolizumab) in patients with unresectable or metastatic melanoma
Expanded management team with appointment of Ashley Robinson as SVP of Strategy and Finance
EVENTS AFTER THE END OF THE PERIOD
(R) Positive initial efficacy data from Phase 2a trial of triple combination of the company's lead anti-FcyRIIB antibody BI-1206, rituximab and Calquence® for the treatment of non-Hodgkin's Lymphoma (NHL)
(R) Phase 1 data of the company's second anti-TNFR2 antibody BI-1910 as monotherapy for the treatment of solid tumors
BioInvent achieved ISO 26000 Verification, highlighting commitment to ESG and transparency
Composition of matter patent for the BI-1808 antibody granted in Japan. It also covers the use of the antibody in the treatment of cancer.
EARLIER DURING 2024, IN BRIEF
(R) Additional positive efficacy data with single agent BI-1808 from the Phase 2a anti-TNFR2 program
(R) Phase 1 data for BI-1206 in combination with KEYTRUDA in patients with solid tumors presented at ASCO 2024
(R) Clinical efficacy and excellent safety for anti-TNFR2 agent BI-1808 presented at ASCO 2024
(R) Phase 1/2a data presented at EHA 2024 for BI-1206 with rituximab in NHL
(R) CASI Pharmaceuticals reported positive interim Phase 1 data for BI-1206 in the treatment of relapsed/refractory indolent NHL in China
ESMO presentations highlighting progress from the Phase 1 trial of BI-1910 monotherapy in solid tumors and Phase 1 trial of the oncoloytic virus BT-001 (anti-CTLA-4) as a single agent and in combination with KEYTRUDA® (pembrolizumab) in patients with solid tumors
Two clinical trial collaboration and supply agreements signed with MSD to evaluate BI-1607 in combination with KEYTRUDA and ipilimumab, and to evaluate BI-1910 in combination with KEYTRUDA
PAGE 2024 presentation showcased model-informed development of BI-1808
Clinical supply agreement signed with AstraZeneca (LSE/STO/Nasdaq: AZN) to evaluate BioInvent's anti-FcyRIIB antibody, BI-1206, in combination with rituximab and Calquence (acalabrutinib), in a Phase 1/2a study in NHL
ANTICIPATED 2025 MILESTONES
Additional Phase 2a monotherapy data of BI-1808 in solid tumors and T-cell lymphoma to be shared in mid-2025
Data from the ongoing Phase 2a trial of BI-1206 in combination with rituximab and Calquence (acalabrutinib) in NHL expected in mid-2025
Phase 1 data of BI-1206 as a subcutaneous formulation in combination with KEYTRUDA in solid tumors anticipated in mid-2025
First BI-1910 Phase 2a single agent data expected H2 2025
Phase 1 data from Part B, dose escalation of BI-1910 in combination with pembrolizumab expected H2 2025
Data from Phase 2a dose-expansion study of BI-1808 in combination with KEYTRUDA in patients with advanced solid tumors and T-cell lymphoma anticipated in H2 2025
Initial data from the Phase 1b trial evaluating BI-1607 in combination with ipilimumab and KEYTRUDA in patients with unresectable or metastatic melanoma expected in H2 2025
(R)= Regulatory event
FINANCIAL INFORMATION Fourth quarter 2024 • Net sales SEK 21.4 (15.3) million. • Profit/loss after tax SEK -116.9 (-97.2) million. • Profit/loss after tax per share before and after dilution SEK -1.78 (-1.48) • Cash flow from operating activities SEK -98.3 (-72.4) million.
January - December 2024 • Net sales SEK 44.7 (71.5) million. • Profit/loss after tax SEK -429.4 (-330.3) million. • Profit/loss after tax per share before and after dilution SEK -6.53 (-5.02). • Cash flow from operating activities SEK -380.5 (-341.7) million. • Liquid funds, current and long-term investments as of December 31, 2024: SEK 867.2 (1,283.0) million.
The complete interim report is available for download below and on the company's website under Financial reports .
INVITATION TO PRESENTATION OF THE YEAR-END REPORT 2024 BioInvent's CEO Martin Welschof will present the report together with CFO Stefan Ericsson. The presentation will be held in English. When: Thursday February 27, 2025, at 4:00 pm CET
If you wish to ask questions and participate via telephone, please register at the link below. After registration you will be provided with a phone number and a conference ID to access the conference. https://conference.inderes.com/teleconference/?id=5002731.
The conference call will be made available on the company website after the call.
About BioInvent BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory drug candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities.
The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com.
For further information, please contact: Cecilia Hofvander, VP Investor Relations +46 (0)46 286 85 50 cecilia.hofvander@bioinvent.com
