Denovo Biopharma LLC Announces FDA Approval of IND to Initiate First Biomarker-Guided Global CNS Clinical Trial for Treatment-Resistant Depression (TRD)

SAN DIEGO,Feb. 1,2022 --Denovo Biopharma LLC ("Denovo"),a pioneer in applying precision medicine to the development of innovative therapies,today announced that the FDA has authorized the company's investigational new drug (IND) application of DB104 (liafensine) for treatment-resistant depression (TRD) to proceed,which enables Denovo to start a global Phase2b clinical trial to assess the safety and efficacy of liafensine in patients with TRD. This will be the third potentially pivotal global trial that Denovo is conducting,and more importantly,may be the first ever genetic biomarker-guided clinical trial conducted for central nervous system (CNS) diseases.

Xiao-Xiong Lu,PhD,Denovo's Chief Technical Officer,said,"CNS diseases are notoriously difficult to treat,and lack of precision medicines may contribute to the modest success in developing innovative drugs in this area. Denovo used its unique biomarker platform to identify a novel predictive biomarker named Denovo Genomic Marker 4 (DGM4™),which is highly associated with clinical response to liafensine in patients with TRD. We are excited to launch this biomarker-guided TRD trial that may provide a scientific,personalized medicine approach rather than the trial-and-error method that is typically used today. This could potentially be a game–changer for the field of CNS drug development."

About Treatment-Resistant Depression

Major depressive disorder (MDD) afflicts more than 15 million people in the US in any given year. Approximately one-third of people with MDD do not respond adequately to at least two different antidepressants of adequate dose and duration in the current depressive episode and are considered to have treatment-resistant depression (TRD). TRD is a chronic condition that places an ongoing emotional,functional,and economic burden on the individual,their loved ones,and society.

About Denovo Biopharma

Denovo Biopharma LLC is a clinical-stage biopharmaceutical company that uses novel biomarker approaches to executes efficient clinical trials in targeted patient populations to optimize the probability of successful trials. Denovo has 8 late clinical stage drugs in its pipeline addressing major unmet medical needs in oncology and CNS diseases,most of which are first–in–class drugs with global rights. Its first biomarker-guided trial for its lead asset DB102 (enzastaurin) has completed enrollment of patients with diffuse large B-cell lymphoma (DLBCL) in a Phase3 clinical trial in the US and China,and enrollment is ongoing in a Phase3 trial in glioblastoma (GBM). In addition to Denovo-discovered biomarkers for DB102 and DB104,Denovo also announced recently the discovery of a novel biomarker for its gene therapy program DB107 (Toca511/TocaFC) for recurrent high-grade glioma. For additional information,please visit www.denovobiopharma.com.

Contact:

Michael F. Haller,Chief Business Officer

Denovo Biopharma LLC

mhaller@denovobiopharma.com

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