TSHA
Taysha Gene Therapies, Inc.5.82
+0.06+1.04%
Dec 16, 4:00:01 PM EST
Earnings Call Transcripts
This Quarter (Q1 '26)
No earnings call transcript available yet
Last Quarter (Q4 '25)
FY Q4 '25
BLA scenarios, data durability detailed
Q&A reinforced scripted progress on TSHA-102 but detailed flexible BLA paths post-REVEAL pivotal six-month interim in Q2 2026, potentially filing immediately or via rolling submission if FDA seeks more data. Management outlined Q2 Part A update on all 12 patients at minimum 12 months, expecting sustained gains across milestones and skills with vignettes; no milestone losses seen. Intrathecal scalability targets 50% of patients outside centers of excellence. They dismissed Daybue EU read-through, stressing functional gains over scales, and differentiated from Neurogene's slower profile. No losses of gains yet. Watch Q2 for pivotal trajectory.
Key Stats
Market Cap
1.59BP/E (TTM)
-Basic EPS (TTM)
-0.33Dividend Yield
0%Recent Filings
10-K
FY2025 results
Taysha Gene Therapies reported no revenue for FY2025 ended December 31, 2025, as a clinical-stage biotech with no approved products. Q4 saw completion of dosing all 12 patients across REVEAL Phase 1/2 trials for TSHA-102 in Rett syndrome, including eight at high dose (1x1015 total vg) and four at low dose. Positive May 2025 data showed the first 10 patients gaining developmental milestones in communication, fine/gross motor function, with no treatment-related serious adverse events through March 2026 cutoff. No financial statements provided in filing. Cash position stood at $544.8 million market value of non-affiliate shares as of June 30, 2025. Longer-term data looms Q2 2026. Clinical trial delays threaten momentum.
8-K
TSHA-102 trials advance swiftly
Taysha Gene Therapies reported full-year 2025 results on March 19, 2026, posting a $109.0M net loss on $86.4M R&D spend, up from 2024, while ending with $319.8M cash into 2028. Multiple patients dosed in the REVEAL pivotal trial for TSHA-102 in Rett syndrome; on track to finish dosing Q2 2026 alongside FDA-cleared ASPIRE trial. TSHA-102 well tolerated. Cash fuels BLA push.
10-Q
Q3 FY2025 results
Taysha Gene Therapies posted a Q3 net loss of $32.7M, narrower than $25.5M last year yet wider q/q from Q2's $32.7M-derived operating loss, driven by R&D expenses jumping 72% y/y to $25.7M on program acceleration while G&A held steady. Cash swelled to $297.3M on $215.7M May offering net proceeds, funding operations past twelve months despite $66.4M YTD operating burn; term loan sits at $50.9M fair value (maturing 2030). No revenue as Astellas Rett option expired unexercised, unlocking TSHA-102 rights. Diluted EPS of -$0.09 aligns with 353M shares. Litigation risk lingers from shareholder suits over 2023 PIPE.
8-K
TSHA-102 gains Breakthrough designation
Taysha Gene Therapies secured FDA Breakthrough Therapy designation for TSHA-102 in Rett syndrome and finalized REVEAL pivotal trial alignment, including a 6-month interim analysis to potentially expedite BLA submission. Q3 net loss widened to $32.7M from $25.5M amid $25.7M R&D spend, yet cash hit $297.3M funding into 2028. First patient dosing starts Q4 2025. Sales agreement now allows $212M ATM offering.
8-K
Regains TSHA-102 rights
Taysha Gene Therapies regained full rights to its lead TSHA-102 program for Rett syndrome after the 2022 Astellas option agreement expired on October 16, 2025. Part A REVEAL data showed 100% response rate on developmental milestones and FDA Breakthrough Therapy designation. First patient dosing in the pivotal trial starts this quarter. Full control boosts strategic flexibility.
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