GLOBAL RESEARCH ARCHIVE
Q1: Ph1 HV SAD/MAD Initiated For SEP-479 – Ph2b In CSU Starting H2:26
Research evidence excerpt
Q1: Ph1 HV SAD/MAD Initiated For SEP-479 – Ph2b In CSU Starting H2:26
Biotechnology
Septerna
TD SECURITIES (USA) LLC EARNINGS UPDATE
May 11, 2026
Price: $23.57 (05/11/2026) Q1: Ph1 HV SAD/MAD Initiated For SEP-479 –
Price Target: NA Ph2b In CSU Starting H2:26
BUY (1)
ESG SCORE: 58/100
Yaron Werber, M.D. THE TD COWEN INSIGHT
646 562 1415
Q1 revs of $27M from NVO collaboration. Ph1 HV SAD/MAD for SEP-479 (PTH1R) initiated in
yaron.werber@tdsecurities.com
April w/data in late '26/early '27. Compelling Ph1 PoC for SEP-631 (MRGPRX2 NAM) showing
Sarah Cai, Ph.D. robust, dose-dependent wheal suppression w/QD oral dosing supports Ph2b CSU start in
646 562 1447 H2:26. $522M cash runway into 2029. We continue to like the platform, pipeline, and stock at
sarah.cai@tdsecurities.com
these levels.
Jaena Han, Ph.D.
646 562 1428 Our Take: SEP-479 Ph1 HV SAD/MAD Study Initiated, Data In Late '26/Early '27 – SEP-631
jaena.han@tdsecurities.com Delivers Strong POC In HV, Ph2b CSU Study Planned For H2:26
Steven Ionov, Ph.D. In April ’26, SEP-479 initiated its Ph1 SAD/MAD study in healthy volunteers (HV) with data
646 562 1478
expected in late '26/early '27. 'SEP-479 is a potent and selective oral small molecule PTH1R
steven.ionov@tdsecurities.com
agonist for hypoparathyroidism (HP). We also view the Ph1 data for SEP-631 (MRGPRX2 NAM)
Key Data as offering a clear clinical proof-of-mechanism and meaningful validation of Septerna’s Native
Symbol NASDAQ: SEPN Complex Platform. SEP-631 demonstrated potent, dose-dependent inhibition of icatibant-
Beta: 2.20 induced wheal formation and a placebo-like safety profile and PK supportive of once-daily
52-Week Range: $30.86-$6.73 oral dosing without food restrictions (note on AAAAI data here). The Ph2b study is initiating
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