Dale Christensen, Ph.D.

Chief Science Officer for Climatic Health, a science-led consumer health company focused on respiratory resilience and performance in the context of environmental stressors (e.g., air pollution, allergens, wildfire smoke). – Lead scientific strategy across product development, evidence generation, and regulatory-adjacent decision making. – Design and oversee in vivo, in vitro and human efficacy studies. – Guide translational approach bridging pulmonary biology, aerosolized delivery systems, and real-world consumer use – Partner closely with product, regulatory, and leadership teams to ensure scientific rigor, credibility, and responsible claims

Providing consulting in translational product development across indications from respiratory disease, inflammation, oncology, CNS and antibacterial development. Provides both strategic guidance and hands on operational management of preclinical and clinical studies from research through toxicology, IND/CTA/CTN preparation and early clinical development including lead optimization, lead selection, in vivo pharmacology, bioanalytical development and IND-enabling toxicology with intravenous, oral, and inhalation routes of delivery. Client support for financing and partnering has resulted in more than $100M in financing and an IPO.

-Since the formation of TFF Pharmaceuticals, successfully translated three programs from concept through Phase 1 in both healthy normal (and one Phase 1b study in asthma patients) and advanced two of these programs into Phase 2 clinical trials in 4 years - all during Covid! -Developing and executing the nonclinical and clinical development strategy for the company -Leading the development, execution and operation of TFF’s in-house pharmacology, pre-clinical and clinical studies and with external partners -Designing and execution of clinical study protocols and databases, toxicology studies and CMC activities for multiple compounds, as well as conducting review of clinical trial data and tasks for database lock - Providing oversight of clinical data management, preparing documents for clinical data collection and processing, and filing IND/CTA/CTNs

Lead translational product development of a novel disease modifying therapy for Cystic Fibrosis - including lead optimization and all preclinical development activities. After building the company and raising an $18 M Series A investment, I successfully guided a early research and development efforts including lead optimization, lead selection, in vivo pharmacology, bioanalytical development leading to the discovery and selection of SPX-101 for clinical development. Following lead selection, I created the development plans and ran the non-clinical IND-enabling pharmacology and toxicology studies to prepare SPX-101 for clinical trials. My leadership was essential to translate this program from concept through initiation of clinical trials in 25 months. SPX-101 recently completed Phase II testing and demonstrated clinical efficacy for improvement of lung function in cystic fibrosis patients and is the first genotype independent drug developed to treat lung disease in all CF patients.

Invented OP449, a novel anti-tumor compound and secured $1.25 M in non-dilutive funding to prepare OP449 for clinical development Identified Key Academic Opinion Leaders in each tumor type; established, gained funding for, and managed collaborative projects for validation of the activity of OP449 in AML, CML, CLL, Breast, Prostate, and Pancreatic cancers; and published outcomes in leading scientific journals Developed the biomarker strategy for patient selection during clinical development Designed and executed studies for the IND package of OP449 including GMP production for CMC, non-clinical pharmacology/toxicology studies, and draft clinical protocols.

Secured $2.3M in non-dilutive funding to drive preclinical development activities Established, gained funding for, and managed collaborative projects Key Academic Opinion Leaders for validation of preclinical activity of lead compounds in stroke, sepsis, and Alzheimer’s disease and published outcomes in leading scientific journals Managed a group of scientist in performing in vitro and in vivo pharmacology assays that demonstrated a novel mechanism of action studies for anti-inflammatory apoE peptides Designed the complete IND package for two lead compounds that included CMC, toxicology plans, and clinical protocols for CNS indications that lead one IND filing Managed contracted research for development of GLP bioanalytical assays and dose formulation assays for pharmacokinetic studies and IND-enabling toxicology studies

Identified novel targets for antimicrobial drug development and implemented HTS assays Supported business development activities by presenting capabilities to potential collaborating pharma partners throughout the world Lead collaborative projects with large pharma partners for HTS assay development that delivered assays to achieve more than $1M in milestone payments Managed medicinal chemistry, structural biology, HTS, and protein production activities

Invented novel nuclear receptor screening technology that lead to acquision by Karo Bio Developed BioKey® HTS technology and established capacity to screen up to 100,000 compound per day with less than $300,000 in capital equipment. Authored successful NIH SBIR proposals Managed medicinal chemistry, structural biology, HTS, and protein production activities