(Biopharma) CHRS - Upcoming Catalysts in March to Announce Progress for April 2022 Release?

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Ticker: CHRS

Two Upcoming catalysts in the short term

Senior management will present at the following investor conferences in March.

  • 42nd Annual Cowen Health Care Conference on Wednesday, March 9 at 10:30 a.m. ET
  • Barclays Global Healthcare Conference on Tuesday, March 15 at 2:35 p.m. ET

Recent $300,000,000 investment from Pharmakon in January in which Balance sheet strengthened to support commercial launches of as many as five new products in 2022 and 2023. As part of this investment they were given 50mil specifically to support Toripalimab to aim for target action in April 2022. This combined with the two conferences announced surely means progress has been made towards this.

Pharmakon Investment Press Release

A third tranche of $50 million will become available subject to certain conditions including approval by the U.S. Food and Drug Administration (FDA) of the biologics license application (BLA) for Coherus’ PD-1 inhibitor, toripalimab, for nasopharyngeal carcinoma, currently under priority review with a target action date in April 2022.

Investor Slides - JP Morgan Jan 2022

Also have had recent Earnings Call on Feb 17 which they say

"Now with respect to our immuno-oncology programs, you may recall that in November, we announced the FDA granted priority review for the BLA for toripalimab for the treatment of nasopharyngeal carcinoma. An indication with no FDA-approved cancer immunotherapy options and for which toripalimab has breakthrough therapy and orphan drug designation. The BLA review is progressing well toward the target action date of April 30, which is about 10 weeks from now. Toripalimab clinical profile continues to strengthen across indications.

In December, we announced that toripalimab plus chemotherapy demonstrated a statistically significant overall survival benefit and a prespecified interim analysis on the CHOICE-1 clinical trial for the first-line treatment of advanced non-small cell lung cancer. This built on other first-line indications in esophageal squamous cell carcinoma and nasopharyngeal carcinoma, where we have seen a robust benefit both the progression-free survival and overall survival. We’ve also made progress with our clinical-stage – mid-stage I-O strategy. In January, we initiated the process to exercise our option and license JS006, a TIGIT targeted antibody developed by Junshi BioSciences our partner, which they are evaluated in a study combination with toripalimab."

Full Earnings Call Transcript

Not too worried if there is no short term pop as happy to keep this as part of the long term portfolio.

Personally playing shares in this one - 500 shares @ 11.75

Any more DD or Info encouraged!

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I am bearish because of the following reasons

  • the PDUFA catalyst in April is for a very small indication*
  • there is uncertainty regarding the most important indications such as non-small cell lung cancer
  • FDA denied approval recently for similar PD-1 treatment (Tyvyt) because of missing diversity in clinical trials and toripalimab in nasopharyngeal carcinoma review is based on China-only trials.
  • PD-L1 treatments (e.g. Keytruda) are the standard of care and have a huge market share and the PD1 treatment should be compared to PD-L1 treatments as it is the standard of care and not chemotherapy

*toripalimab in combination with gemcitabine and cisplatin for the first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

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