Form 8-K
8-K — Taysha Gene Therapies, Inc.
Accession: 0001193125-26-207633
Filed: 2026-05-06
Period: 2026-05-06
CIK: 0001806310
SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 6, 2026
Taysha Gene Therapies, Inc.
(Exact name of registrant as specified in its Charter)
Delaware
001-39536
84-3199512
(State or Other Jurisdiction
of Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
3000 Pegasus Park Drive, Suite 1430
Dallas, Texas
75247
(Address of Principal Executive Offices)
(Zip Code)
(214) 612-0000
(Registrant’s Telephone Number, Including Area Code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange
on which registered
Common Stock, $0.00001 par value
TSHA
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02
Results of Operations and Financial Condition.
On May 6, 2026, Taysha Gene Therapies, Inc. reported financial results for the quarter ended March 31, 2026, and recent business highlights. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference.
The information in this Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits
Exhibit
No.
Description
99.1
Press Release, dated May 6, 2026.
104
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Taysha Gene Therapies, Inc.
Dated: May 6, 2026
By:
/s/ Kamran Alam
Kamran Alam
Chief Financial Officer
EX-99.1
EX-99.1
Filename: d99032dex991.htm · Sequence: 2
EX-99.1
Exhibit 99.1
Taysha Gene Therapies Reports First Quarter 2026 Financial Results and Provides Corporate Update
Reaffirmed FDA alignment on TSHA-102 BLA pathway, including pivotal trial design, endpoints and
potential to submit for approval based on REVEAL pivotal trial 6-month interim analysis, following recent breakthrough therapy Type B meeting
Further advanced dosing in the REVEAL pivotal trial, with enrollment in the ASPIRE trial ongoing across multiple sites; on track to complete
dosing in REVEAL and ASPIRE in Q2 2026
Maintained favorable tolerability profile with no treatment-related SAEs or DLTs in REVEAL
Phase 1/2 and REVEAL pivotal trials as of May 2026 data cutoff; plan to present longer-term safety and efficacy data from Part A of REVEAL Phase 1/2 trials in Q2 2026
Initiated BLA-enabling PPQ campaign for TSHA-102 in April
2026; completion expected in Q4 2026
Conference call and webcast today at 8:30 AM ET
Dallas – May 6, 2026 – Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage
biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today reported financial results for the first quarter ended March 31, 2026, and
provided a corporate update.
“We continued to execute our clinical development strategy for TSHA-102 and
recently reaffirmed alignment with the FDA on our pathway to a BLA filing, including trial design, endpoints and the potential to submit for approval based on the six-month interim analysis from the REVEAL
pivotal trial,” said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. “We further advanced dosing in the REVEAL pivotal trial, with enrollment in the ASPIRE trial ongoing across multiple sites, and we remain on track to
complete dosing in both trials this quarter. In parallel, we plan to report longer-term safety and efficacy data from Part A of our REVEAL Phase 1/2 trials in the second quarter of this year.”
Mr. Nolan continued, “Our pivotal development strategy is grounded in the rigor of our natural history analysis and Part A data collection and
evaluation, with trial design, endpoints and statistical analyses developed based on discussions with the FDA. In our upcoming Part A data readout, we expect to report longer-term follow-up, including at least
12-month data from all 12 pediatric, adolescent and adult patients treated with TSHA-102. These results will include functional gains based on natural history-defined
developmental milestones and additional skills and improvements that impact activities of daily living. We look forward to sharing this data as we continue to demonstrate the differentiated opportunity for
TSHA-102 to deliver meaningful benefit to a broad population of patients with Rett syndrome who continue to face high unmet medical need.”
Recent Corporate and TSHA-102 Program Highlights
•
Reaffirmed FDA Alignment on Planned BLA Submission Pathway for
TSHA-102. Following a recent initial breakthrough therapy Type B multidisciplinary meeting with the U.S. Food and Drug Administration (FDA), Taysha reaffirmed alignment on the planned pathway to a
Biologics License Application (BLA) submission for TSHA-102, including:
•
Pivotal trial design and endpoints
•
BLA submission scenarios, including the potential to submit for approval based on the six-month interim analysis from the REVEAL pivotal trial
•
Further Advanced Dosing in REVEAL Pivotal Trial, with Multiple Patients Dosed Across Multiple
Clinical Trial Sites. The single-arm, open-label trial is evaluating a single intrathecal (IT) administration of high dose TSHA-102 (1x1015 total vector genomes (vg)) in 15 females between the ages of 6 and <22 years in the developmental plateau population of Rett syndrome. The primary endpoint will assess response rate, defined
as the percentage of patients who gain or regain ≥one of the 28 natural history-defined developmental milestones, with each patient serving as their own control. Standardized milestone assessments will be administered and captured on video at pre- and post-treatment timepoints, with determination of milestone gain/regain upon video-evidence review by independent, blinded central raters based on prespecified definitions of achievement for each milestone.
The study includes a six-month interim analysis that may serve as the basis for BLA submission.
•
Enrollment in ASPIRE Trial is Ongoing Across Multiple Clinical Trial Sites. The ASPIRE safety-focused
trial is designed to support a planned BLA submission to enable broad labeling of TSHA-102 for patients aged ≥2 years with Rett syndrome. Taysha is enrolling three females with Rett syndrome, aged 2 to
<4 years, to evaluate the safety and preliminary efficacy of a single IT administration of high dose TSHA-102 (1x1015 total vg), scaled to account
for the lower brain volume in 2 to <4-year-olds. A minimum of three months of ASPIRE safety data will be included in the planned BLA submission, while efficacy in the
2 to <6-year-old population will be extrapolated from data collected in the REVEAL pivotal trial.
•
TSHA-102 Continues to be Generally Well Tolerated. High dose (1x1015 total vg) and low dose (5.7x1014 total vg) TSHA-102 continue to be generally well tolerated
with no treatment-related serious adverse events (SAEs) or dose-limiting toxicities (DLTs) in all patients treated in the REVEAL Phase 1/2 and REVEAL pivotal trials as of the May 2026 data cutoff.
•
Initiated BLA-Enabling PPQ Campaign for
TSHA-102 Using Commercial Manufacturing Process in April 2026. Following a Type C meeting in January 2026, the FDA endorsed the Company’s proposed Process Performance Qualification (PPQ) campaign
strategy in support of the BLA submission, enabling the execution of the BLA-enabling PPQ campaign using the commercial manufacturing process. Initiating the PPQ campaign ensures Chemistry Manufacturing and
Controls (CMC) activities remain aligned with clinical development timelines for the planned BLA submission.
•
Peer-Reviewed Publication Further Validates Lumbar IT Dosing as a Safe, Effective and Minimally Invasive
Approach to Deliver a Gene Therapy to the CNS. The publication titled “rAAV9 Vector Biodistribution in Nonhuman Primate Brain and Spinal Cord Following Lumbar Intrathecal Infusion” was published in Frontiers in Medicine
– Gene and Cell Therapy (DOI: 10.3389/fmed.2026.1819594)
on April 28, 2026. The publication includes preclinical data previously presented at the 2025 International Rett Syndrome Foundation (IRSF) Rett Syndrome Scientific Meeting,
demonstrating IT and direct-to-brain intra-cisterna magna (ICM) administration showed comparable, consistent and widespread biodistribution of AAV9 vector throughout the brain and spinal cord regions in
non-human primates.
•
Abstract Accepted for Presentation at Upcoming American Society of Gene and Cell Therapy (ASGCT) 2026 Annual
Meeting. The poster titled “Superior expression of self-complementary AAV and comparable functionality of mini and full-length MECP2 support the design of TSHA-102 for Rett syndrome”
will be presented on May 14, 2026, and highlights new preclinical in vitro data demonstrating that self-complementary AAV9 achieved significantly higher MeCP2 expression compared to single-stranded AAV9 in neuronal mouse cell models, and the
comparable functionality of mini and full-length MECP2.
Anticipated Milestones
•
Completion of dosing in the REVEAL pivotal trial is expected in the second quarter of 2026
•
Completion of dosing in the ASPIRE trial is expected in the second quarter of 2026
•
Update on longer-term safety and efficacy data from Part A of the REVEAL Phase 1/2 trials (n=12) is expected in
the second quarter of 2026
•
Completion of BLA-enabling PPQ campaign for TSHA-102 is expected in the fourth quarter of 2026
First Quarter 2026 Financial Highlights
Research and Development Expenses: Research and development expenses were $33.8 million for the three months ended March 31, 2026,
compared to $15.6 million for the three months ended March 31, 2025. The $18.2 million increase was primarily driven by BLA-enabling PPQ manufacturing initiatives performed during the three
months ended March 31, 2026, and higher clinical expenses from the REVEAL and ASPIRE trials. Compensation expenses, including non-cash stock-based compensation, also increased as a result of additional
research and development headcount.
General and Administrative Expenses: General and administrative expenses were $9.7 million for the three
months ended March 31, 2026, compared to $8.2 million for the three months ended March 31, 2025. The increase of $1.5 million was primarily due to higher compensation expenses, including non-cash stock-based compensation expense, and increases in
consulting and professional fees, including commercial launch-readiness initiatives.
Net Loss: Net loss for the three months ended March 31,
2026, was $42.4 million, or $0.12 per share, compared to a net loss of $21.5 million, or $0.08 per share, for the three months ended March 31, 2025.
Cash and Cash Equivalents: As of March 31, 2026, Taysha had $276.6 million in cash and cash equivalents. The Company expects that its current
cash resources will be sufficient to fund planned operating expenses into 2028.
Conference Call and Webcast Information
Taysha management will host a live conference call and webcast today at 8:30 a.m. ET to review its financial and operating results and provide a corporate
update. Participants may access the live webcast of the conference call by visiting Taysha’s website.
About TSHA-102
TSHA-102 is a self-complementary intrathecally delivered AAV9
investigational gene transfer therapy in clinical evaluation for Rett syndrome. Designed as a one-time treatment, TSHA-102 aims to address the genetic root cause of the
disease by delivering a functional form of MECP2 to cells in the CNS. TSHA-102 utilizes a novel miRNA-Responsive Auto-Regulatory Element (miRARE) technology designed to mediate levels
of MECP2 in the CNS on a cell-by-cell basis without risk of overexpression. TSHA-102 has received Breakthrough
Therapy, Regenerative Medicine Advanced Therapy, Fast Track and Orphan Drug and Rare Pediatric Disease designations from the FDA, Orphan Drug designation from the European Commission and Innovative Licensing and Access
Pathway designation from the Medicines and Healthcare products Regulatory Agency.
About Rett Syndrome
Rett syndrome is a rare neurodevelopmental disorder caused by mutations in the X-linked MECP2 gene
encoding methyl CpG-binding protein 2 (MeCP2), which is essential for regulating neuronal and synaptic function in the brain. The disorder is characterized by loss of communication and hand function, slowing
and/or regression of development, motor and respiratory impairment, seizures, intellectual disabilities and shortened life expectancy. Rett syndrome progression is divided into four key stages, beginning with early onset stagnation at 6 to 18 months
of age followed by rapid regression, plateau and late motor deterioration. Rett syndrome primarily occurs in females and is one of the most common genetic causes of severe intellectual disability. Currently, there are no approved disease-modifying
therapies that treat the genetic root cause of the disease. Rett syndrome caused by a pathogenic/likely pathogenic MECP2 mutation is estimated to affect between 15,000 and 20,000 patients in the U.S., EU, and U.K.
About Taysha Gene Therapies
Taysha Gene
Therapies (Nasdaq: TSHA) is a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system. Its lead clinical program TSHA-102 is in development for Rett syndrome, a rare neurodevelopmental disorder with no approved disease-modifying therapies that address the genetic root cause of the disease. With a singular focus on developing
transformative medicines, Taysha aims to address severe unmet medical needs and dramatically improve the lives of patients and their caregivers. The Company’s management team has proven experience in gene therapy development and
commercialization. Taysha leverages this experience, its manufacturing process and a clinically and commercially proven AAV9 capsid in an effort to rapidly translate treatments from bench to bedside. For more information, please visit
www.tayshagtx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as
“anticipates,” “believes,” “expects,” “intends,” “projects,” “plans,” and “future” or similar expressions are intended to identify forward-looking statements.
Forward-looking statements include, but are not limited to, statements concerning the potential of TSHA-102 and Taysha’s other product candidates to positively impact quality of life and alter the course
of disease in the patients Taysha seeks to treat, Taysha’s research, development, regulatory and manufacturing plans for its product candidates, communications with the FDA, including with respect to the BLA for
TSHA-102, the potential for Taysha’s product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be
successfully distributed and marketed and the potential market opportunity for Taysha’s product candidates, and the ability of Taysha’s current cash resources to support planned operating expenses into 2028. Forward-looking statements
are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements.
Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Taysha’s business are described in detail
in Taysha’s Securities and Exchange Commission (“SEC”) filings, including in our Annual Report on Form 10-K for the full-year ended December 31, 2025, which are available
on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that Taysha makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Taysha
disclaims any obligation to update these statements except as may be required by law.
Taysha Gene Therapies, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
For the Three Months
Ended March 31,
2026
2025
Revenue
$
—
$
2,302
Operating expenses:
Research and development
33,809
15,565
General and administrative
9,677
8,158
Total operating expenses
43,486
23,723
Loss from operations
(43,486
)
(21,421
)
Other income (expense):
Change in fair value of warrant liability
—
102
Change in fair value of term loan
(1,470
)
(1,530
)
Interest income
2,586
1,326
Interest expense
(9
)
(19
)
Other (income) expense
(31
)
13
Total other income (expense), net
1,076
(108
)
Net loss
$
(42,410
)
$
(21,529
)
Net loss per common share, basic and diluted
$
(0.12
)
$
(0.08
)
Weighted average common shares outstanding, basic and diluted
366,632,827
269,306,331
Taysha Gene Therapies, Inc.
Condensed Consolidated Balance Sheet Data
(in thousands, except share and per share data)
March 31,
2026
December 31,
2025
ASSETS
Current assets:
Cash and cash equivalents
$
276,576
$
319,767
Restricted cash
449
449
Prepaid expenses and other current assets
5,225
4,431
Total current assets
282,250
324,647
Restricted cash
2,315
2,315
Property, plant and equipment, net
6,450
6,736
Operating lease
right-of-use assets
9,155
9,439
Other non-current assets
181
183
Total assets
$
300,351
$
343,320
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
4,564
$
6,275
Accrued expenses and other current liabilities
15,534
20,277
Total current liabilities
20,098
26,552
Term loan, net
48,961
50,106
Operating lease liability, net of current portion
17,766
18,172
Other non-current liabilities
1,582
1,552
Total liabilities
88,407
96,382
Stockholders’ equity
Common stock, $0.00001 par value per share; 700,000,000 shares authorized and 287,276,885 and
285,051,648 issued and outstanding as of March 31, 2026 and December 31, 2025, respectively
3
3
Additional paid-in capital
964,666
958,427
Accumulated other comprehensive income (loss)
985
(192
)
Accumulated deficit
(753,710
)
(711,300
)
Total stockholders’ equity
211,944
246,938
Total liabilities and stockholders’ equity
$
300,351
$
343,320
Company Contact:
Hayleigh Collins
Senior Director, Corporate Communications and
Investor Relations
Taysha Gene Therapies, Inc.
hcollins@tayshagtx.com
Media Contact:
Carolyn Hawley
Inizio Evoke
Carolyn.hawley@inizioevoke.com
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Reference 1: http://www.xbrl.org/2003/role/presentationRef
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-Name Exchange Act
-Number 240
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- Definition
Name of the Exchange on which a security is registered.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
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- Definition
Trading symbol of an instrument as listed on an exchange.
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No definition available.
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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
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Reference 1: http://www.xbrl.org/2003/role/presentationRef
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-Name Securities Act
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