Michael Haas

• Led translational medicine strategic design, execution, and data analysis to support the randomized Phase 2 DeFianCe study of DKN-01 in CRC. • Coordinated integration of proteomic, molecular, and genetic biomarkers, including ELISA, MSD, SomaLogic, IHC, RNA-seq, RNAscope, and ctDNA, into the DeFianCe study to enable comprehensive translational analysis of clinical samples. • Identified that DKK1 levels strongly correlate with clinical activity in DeFianCe and initiated diagnostic development to support a future Phase 3 trial. • Managed internal bioinformatics support for DeFianCe biomarker analysis and collaborated with external bioinformatics consultants. • Facilitated cross-functional collaboration with internal teams, including Clinical Development, Biometrics, and Translational Science, and with academic partners to align on biomarker strategy and program execution. • Led and managed external initiatives, overseeing CRO associates and vendor teams to ensure timely, high-quality execution of preclinical and clinical biomarker studies. • Designed and initiated in vitro assays and in vivo PK/PD and efficacy studies to evaluate FL-301 (anti-claudin18.2), FL-302 (anti-claudin18.2-41BB bispecific), and FL-501 (anti-GDF-15) for further development. • Mentored junior scientists on preclinical studies, biomarker development, and data analysis.

• Successfully validated a Clinical Laboratory Improvement Amendments (CLIA)-certified tissue-based assay for colorectal and endometrial cancer using RNAscope chromogenic in situ hybridization (CISH). • Designed experiments to inform business development decisions and provide rationale for initiating a clinical trial in a new indication. • Led the design, execution, and data analysis of all in vivo proof-of-concept (POC) and mechanism-of-action (MOA) studies in syngeneic and xenograft mouse cancer models. • Engaged external collaborators and key opinion leaders to guide and focus preclinical strategy for MOA studies. • Created and contributed key documentation and presentations for academic and industry projects, investor meetings, external collaborations, and scientific advisory board meetings. • Managed and mentored associate scientists and technicians in experimental design, execution, instrument training, and data interpretation.

• Identified and established relevant syngeneic and xenograft mouse cancer models for POC studies of therapeutic antibodies. • Evaluated multiple versions of the anti-DKK1 antibody DKN-01 in various syngeneic and xenograft mouse cancer models to assess specific immune responses by FACS, IHC, RNA, and protein expression. • Initiated and validated new in vivo and in vitro assays for MOA studies of therapeutic antibodies. • Performed binding and kinetic assays using Biacore (SPR) to determine antibody affinity and interrogate relevant protein-protein interactions.

Reported directly to the Chief Scientific Officer (CSO) • Secured $2.2M in NIH SBIR grants to advance DeciMab™, a novel monoclonal therapeutic in development for the treatment of vascular inflammatory diseases, and led multiple activities, including PK/PD and efficacy studies through late preclinical and early clinical studies. • Developed surgical techniques to create mouse models of myocardial infarction and kidney ischemia for both acute and long-term evaluation of tissue inflammation and injury, and to evaluate peptide and antibody therapeutics targeting specific ischemic neoantigens. • Facilitated partnerships with Harvard Medical School and Massachusetts General Hospital and successfully established a miniature swine model of myocardial infarction using balloon angioplasty to evaluate the effectiveness of selected therapeutics targeting acute inflammation. • Tested and evaluated DeciMab™ in various animal models of nephropathies (i.e., diabetic, adriamycin-induced) as well as sickle cell disease. • Trained in specific surgical techniques both on-site and off-site and successfully completed and had accepted appropriate IACUC animal protocols necessary to perform all relevant animal procedures. • Employed the principles of surface plasmon resonance (Biacore 3000, Biacore X100, T200) to screen and identify potential drug candidates (IgG, Fab’2, Fab, small peptides) based on binding affinity and kinetic profiles.

• Provided application expertise to end users in academia and industry for all Biacore (SPR) instruments. • Instructed seminars and tutorials on basic operation, data analysis, assay development, and instrument maintenance. • Interfaced and supported account managers, sales specialists, and instrument engineers throughout the sales process.

• Performed studies to understand signaling events that cause insulin resistance and diabetes. • Identified novel serine and threonine phosphorylation sites in the IRS-1 protein by using mass spectrometry and validated by generating phopho-specific antibodies and site-directed mutagenesis. • Investigated the role of p55PIK in insulin and IGF-I signaling by employing a gene replacement strategy in mice. • Generated monoclonal antibodies to p55PIK to elucidate its role in neuronal growth and development.

• Studied the role of a neuronal protein, B-50, and its involvement in brain growth and development in both neonate and adult animals.

• Discovered a novel role of the Na+/K+-ATPase demonstrating direct engagement and signaling through specific tyrosine kinases to regulate cardiac growth and kidney function.