On May 10, 2022 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Janux Therapeutics, MAY 10, 2022, View Source [SID1234614136]).

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"Janux continues to make meaningful progress towards our goal of developing next-generation immunotherapies that are uniquely designed to overcome the clinical limitations of existing TCE approaches," said David Campbell, Ph.D., President and CEO of Janux. "Recently, we were pleased to have presented compelling preclinical data supporting the planned clinical development of both our lead TRACTr programs at PEGS Boston, and we are excited about our progress in advancing IND application submissions for JANX007 and JANX008 in 2022. In tandem, we continue to advance our TROP2-TRACTr and our PD-L1xCD28 costimulatory TRACIr programs, with the goal of submitting an IND for both in 2023. We look forward to driving our pipeline of next-generation immunotherapies into the clinic and executing on our near-term milestones."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

TRACTr candidates advancing as planned.
Janux recently submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for its PSMA-TRACTr (JANX007). cGMP manufacturing of drug substance and drug product has been completed to support the IND and supply first-in-human (FIH) clinical studies.
Janux expects to submit an IND application to the FDA for its EGFR-TRACTr (JANX008) in the second half of 2022. cGMP manufacturing of drug substance has been completed to support the IND and supply FIH clinical studies.
Janux expects to submit an IND application to the FDA for its TROP2-TRACTr in 2023.
Merck nominates second target as part of strategic collaboration and license agreement. In May 2022, Merck nominated a second target under the 2020 Research Collaboration and Exclusive License Agreement between Merck and Janux.
Presented preclinical data for JANX007 and JANX008 from the Company’s TRACTr platform at the 18th Annual Protein & Antibody Engineering Summit (PEGS) Boston. In May 2022, Janux presented preclinical data for the Company’s two lead TRACTr programs at PEGS Boston. JANX007 is a novel TRACTr therapeutic targeting prostate-specific membrane antigen (PSMA) for the treatment of metastatic castration-resistant prostate cancer, and JANX008 is a novel TRACTr therapeutic targeting epidermal growth factor receptor (EGFR) for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, and non-small cell lung cancer.
Data presented showed that JANX007 and JANX008 exhibited enhanced safety and pharmacokinetic properties relative to unmasked T cell engagers (TCE). Both candidates were well tolerated in non-human primate safety studies with limited healthy tissue toxicities and cytokine release syndrome. These data demonstrate key characteristics of JANX007 and JANX008 which support their planned clinical development.
IND-enabling studies ongoing for first TRACIr development candidate, a PD-L1xCD28 costimulatory bispecific for the treatment of solid tumors.
Janux expects to submit an IND application to the FDA for its PD-L1xCD28 TRACIr in 2023. Janux has initiated cGMP manufacturing activities to support production and release of drug substance and drug product.
FIRST QUARTER 2022 FINANCIAL HIGHLIGHTS:

Cash and cash equivalents and short-term investments: As of March 31, 2022, Janux reported cash and cash equivalents and short-term investments of $361.2 million, compared to $375.0 million at December 31, 2021.
Research and development expenses: Research and development expenses for the quarter ended March 31, 2022 were $10.2 million, compared to $1.9 million for the comparable period in 2021.
General and administrative expenses: General and administrative expenses for the quarter ended March 31, 2022 were $4.9 million, compared to $0.7 million for the comparable period in 2021.
Net loss: For the quarter ended March 31, 2022, Janux reported a net loss of $13.4 million, compared to a net loss of $2.3 million for the comparable period in 2021.