UPDATE: H.C. Wainwright Upgrades BeyondSpring Inc. (BYSI) to Buy, $100 PT
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H.C. Wainwright analyst Joseph Pantginis upgraded BeyondSpring Inc. (NASDAQ: BYSI) from Neutral to Buy with a price target of $100.00.
The analyst commented, "This morning BeyondSpring announced the highly anticipated Phase 3 Dublin-3 data in NSCLC patients. Recall this study tested Plinabulin plus docetaxel (DP) (n=278) vs. docetaxel alone (D) (n=281) in 2L and 3L NSCLC patients who were EGFR wild type. The primary endpoint of the study, overall survival (OS) was met with p-value of 0.03 in the intent-to-treat population. Further, the secondary endpoint data are quite impressive to us, showing:
· ORR - p<0.03
· PFS - p<0.01
· Grade 4 neutropenia, cycle 1 day 8: DP arm: 5.3% vs. 27.8% in D arm (p<0.0001)
· 24-month OS rate: DP: 22.1% vs 12.5% for D (p<0.01)
· 36-month OS rate: DP: 11.7% vs. 5.3% for D (p=0.04)
· 48-month OS rate: DP: 10.6% vs. 0% for D (p-value cannot be calculated)
While we were cautious ahead of the NSCLC data, CIN has continued to be the primary driver of the BeyondSpring thesis. While we were 100% right on CIN (with Breakthrough Therapy designation and November 2021 PDUFA date), we were 100% wrong on NSCLC; a dramatic shift in the thesis has now taken place. On the CIN indication alone, we believe the current market cap of $377 million does not place adequate value on the CIN program alone, and was not reflective at all of the NSCLC indication; it appeared the share performance as of late also reflected caution on the Dublin-3 data. It is great to be wrong here, because the data represent a significant improvement in these later line lung cancer patients. As we previously highlighted, launch risk still remains for CIN; however, the NSCLC data make it hard to be on the sidelines now. We do need to highlight that the company's commercial strategy and delineating details of it post-haste is now at the forefront of the thesis; we look forward to visibility to: (1) financing strategy/risk of the company; (2) partnering; and (3) our perception that the takeout potential of the company just increased significantly.
Shares of BeyondSpring Inc. closed at $9.63 yesterday.
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