Taysha Gene Therapies Q3 loss widens to $39.1M

TSHA-102 trial data and FDA feedback on the planned BLA pathway are expected in the first half of 2027.

Available on EDGAR 11/12/2026 - 07:38 AM EST Accepted by SEC EDGAR 11/12/2026 - 07:38 AM EST Learn about SEC filing dates

Rhea-AI Filing Summary

Taysha Gene Therapies, Inc. reported third-quarter 2026 results and a TSHA-102 program update. Research and development expense was $28.8 million, compared with $25.7 million a year earlier, while general and administrative expense was $13.1 million, compared with $8.3 million. Net loss was $39.1 million, or $0.10 per share, versus $32.7 million, or $0.09 per share. Cash and cash equivalents were $422.8 million as of September 30, 2026; Taysha expects its current resources to support planned operating expenses and capital requirements into the second half of 2028.

The REVEAL pivotal and ASPIRE trials of TSHA-102 for Rett syndrome are ongoing. Taysha reported no severe treatment-related serious adverse events or dose-limiting toxicities across its TSHA-102 studies (N=33) as of the November 2026 data cutoff, and said its BLA-enabling PPQ manufacturing campaign met predefined product specifications and comparability criteria. The company expects to report six-month interim REVEAL pivotal-trial data and FDA feedback on the BLA submission pathway in the first half of 2027.

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Positive

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Negative

• Moderate pointQuarterly net loss was $39.1 million, versus $32.7 million a year earlier.

Filing Explained

At September 30, 2026, Taysha reported 325,883,280 common shares issued and outstanding, versus 285,051,648 at December 31, 2025; the higher share count means each existing share represented a smaller fraction of the company, though this filing does not identify the cause of the increase.

8-K Event Classification

2 items: 2.02, 9.01

2 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Research and development expense: $28.8 million General and administrative expense: $13.1 million Net loss: $39.1 million +2 more

5 metrics

Research and development expense $28.8 million Three months ended September 30, 2026; $25.7 million in 2025

General and administrative expense $13.1 million Three months ended September 30, 2026; $8.3 million in 2025

Net loss $39.1 million Three months ended September 30, 2026; $32.7 million in 2025

Net loss per share $0.10 per share Three months ended September 30, 2026; $0.09 per share in 2025

Cash and cash equivalents $422.8 million As of September 30, 2026

Key Terms

BLA, PPQ manufacturing campaign, dose-limiting toxicities, empty capsid percentage

4 terms

BLA regulatory

"FDA feedback on our BLA submission pathway"

PPQ manufacturing campaign technical

"Completed BLA-enabling PPQ manufacturing campaign"

dose-limiting toxicities medical

"no severe treatment-related SAEs or DLTs"

Dose-limiting toxicities are the harmful side effects seen in early clinical trials that are severe enough to stop researchers from raising a drug’s dose. Like a car’s speed limiter marking the safe top speed, DLTs define the maximum tolerable dose, and they matter to investors because they determine whether a medicine can reach effective levels, influence development timelines, costs, and regulatory chances, and thus affect a drug’s commercial prospects.

empty capsid percentage technical

"single-digit empty capsid percentage"

Earnings Snapshot

Research and development expense: $28.8 million · Guidance included

third quarter ended September 30, 2026

Research and development expense $28.8 million Compared with $25.7 million for the three months ended September 30, 2025.

General and administrative expense $13.1 million Compared with $8.3 million for the three months ended September 30, 2025.

Net loss $39.1 million Compared with $32.7 million for the three months ended September 30, 2025.

Net loss per share $0.10 per share Compared with $0.09 per share for the three months ended September 30, 2025.

Guidance

Taysha expects its current cash resources to support planned operating expenses and capital requirements into the second half of 2028.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were TSHA's third-quarter 2026 financial results?

Taysha reported $28.8 million in research and development expense, $13.1 million in general and administrative expense, and a $39.1 million net loss, or $0.10 per share, for the quarter ended September 30, 2026. The prior-year quarter had a $32.7 million net loss, or $0.09 per share.

How much cash did TSHA have, and how long was it expected to last?

Taysha reported $422.8 million in cash and cash equivalents as of September 30, 2026. The company expects its current cash resources to support planned operating expenses and capital requirements into the second half of 2028.

What TSHA-102 safety findings did Taysha report?

Taysha reported no severe treatment-related serious adverse events or dose-limiting toxicities across the REVEAL Phase 1/2, pivotal and ASPIRE studies, covering N=33, as of the November 2026 data cutoff.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false 0001806310 0001806310 2026-11-12 2026-11-12

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): November 12, 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 November 12, 2026, Taysha Gene Therapies, Inc. reported financial results for the quarter ended September 30, 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 November 12, 2026.
104		Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document)

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: November 12, 2026				By:		/s/ Kamran Alam
						Kamran Alam
						Chief Financial Officer

Exhibit 99.1

Taysha Gene Therapies Reports Third Quarter 2026 Financial Results and Provides Corporate Update

REVEAL pivotal and ASPIRE trials evaluating TSHA-102 for Rett syndrome ongoing; expect to report topline data from 6-month interim analysis and FDA feedback on BLA submission pathway in 1H 2027

TSHA-102 continues to be generally well tolerated with no severe treatment-related SAEs or DLTs across REVEAL Phase 1/2, pivotal and ASPIRE trials (N=33) as of the November 2026 data cutoff

Completed BLA-enabling PPQ manufacturing campaign for TSHA-102, which met predefined product specifications as well as comparability criteria for commercial product and clinical material, supporting potential inclusion of REVEAL Part A Phase 1/2 data in the planned BLA

Encore data supporting TSHA-102 clinical program presented at the 55^th Child Neurology Society Annual Meeting

Conference call and webcast today at 8:30 AM ET

Dallas – November 12, 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 third quarter ended September 30, 2026, and provided a corporate update.

“During the third quarter, we continued to make strong progress across our clinical, manufacturing and commercial readiness activities as we advance toward a potential BLA submission for TSHA-102,” said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. “With all patients dosed and having cleared the acute post-dosing safety monitoring period in our REVEAL pivotal and ASPIRE trials with no severe treatment-related serious adverse events or dose-limiting toxicities observed across all studies, our focus now turns to delivering a robust dataset to support our planned BLA submission and further establish the potential of TSHA-102 to address the significant unmet need in Rett syndrome. In parallel, we achieved an important manufacturing milestone with the successful completion of our BLA-enabling PPQ manufacturing campaign, which met the predefined acceptance and comparability criteria previously reviewed with FDA. Importantly, the results further demonstrated our ability to consistently manufacture high-quality product at commercial scale, including an encouraging single-digit empty capsid percentage, a key indicator of product quality that contributes to patient safety. Looking ahead, we believe the first half of 2027 could be a transformative period for Taysha with our plan to report data from the six-month interim analysis of our REVEAL pivotal trial along with expected FDA feedback on our BLA submission pathway, and the anticipated nomination of a second gene therapy development program with a high unmet medical need and robust commercial opportunity as we begin building a broader CNS genetic medicine franchise.”

Recent Corporate and TSHA-102 Program Highlights

• REVEAL Pivotal and ASPIRE Trials Ongoing with TSHA-102 Continued to be Generally Well-Tolerated. High dose (1x10¹⁵ total vector genomes (vg)) and low dose (5.7x10¹⁴ total vg) TSHA-102 continue to be generally well tolerated with no severe treatment-related serious adverse events (SAEs) or dose limiting toxicities (DLTs) in all patients treated in the REVEAL Phase 1/2, REVEAL pivotal and ASPIRE trials (N=33) as of the November 2026 data cutoff. All patients in the REVEAL Phase 1/2 (n=12), pivotal (n=17) and ASPIRE (n=4) trials have cleared the acute post-dosing safety monitoring period typically associated with AAV gene therapies with no dose-limiting toxicities observed across all trials.

• Completed BLA-Enabling Process Performance Qualification (PPQ) Campaign for TSHA-102. Following alignment on the company’s proposed PPQ strategy with the U.S. Food and Drug Administration (FDA), Taysha completed its Biologics License Application (BLA)-enabling PPQ manufacturing campaign for TSHA-102, including the successful production of commercial-scale drug product batches required to validate the final commercial manufacturing process in support of a potential BLA submission and future commercialization of TSHA-102.

• All process parameters and analytical results met predefined product specifications as well as comparability criteria for commercial product and clinical material. Together with the comparability of the clinical material used across the REVEAL Part A and Part B pivotal trials, these results support the potential inclusion of REVEAL Part A data in the planned BLA submission.

• The final TSHA-102 commercial manufacturing process consistently achieved a single-digit empty capsid percentage, an important indicator of product quality that contributes to patient safety. The PPQ results also demonstrate the process consistency and scalability required to support potential commercial demand. The Company plans to discuss these Chemistry Manufacturing and Controls (CMC) data in an anticipated meeting with FDA in the fourth quarter of 2026 to further strengthen the CMC package for the potential BLA submission.

• Showcased Multiple Encore Presentations Supporting TSHA-102 Clinical Program at the 55^th Child Neurology Society Annual Meeting. One oral presentation and three poster presentations were delivered at the 55^th Child Neurology Society Annual Meeting. The presentations, available on the Company’s website, highlighted data previously presented at the 2026 International Rett Syndrome Foundation (IRSF) Scientific Meeting.

Anticipated Milestones

• FDA feedback following CMC Type B meeting expected in the first quarter of 2027

• Topline data from the REVEAL pivotal trial 6-month interim analysis and FDA feedback on the BLA submission pathway for TSHA-102 expected in the first half of 2027

• Expect to nominate an additional gene therapy development candidate targeting a CNS disorder with high unmet need and commence preclinical development activities in the first half of 2027

Third Quarter 2026 Financial Highlights

Research and Development Expenses: Research and development expenses were $28.8 million for the three months ended September 30, 2026, compared to $25.7 million for the three months ended September 30, 2025. The $3.1 million increase was primarily driven by higher clinical expenses from the REVEAL Part A Phase 1/2, REVEAL Part B pivotal 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 $13.1 million for the three months ended September 30, 2026, compared to $8.3 million for the three months ended September 30, 2025. The increase of $4.8 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 September 30, 2026, was $39.1 million, or $0.10 per share, compared to a net loss of $32.7 million, or $0.09 per share, for the three months ended September 30, 2025.

Cash and Cash Equivalents: As of September 30, 2026, Taysha had $422.8 million in cash and cash equivalents. The Company expects that its current cash resources will support planned operating expenses and capital requirements into the second half of 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, Taysha’s manufacturing and commercial readiness activities, Taysha’s anticipated nomination of a second gene therapy development program with a high unmet medical need and strong commercial opportunity, and the ability of Taysha’s current cash resources to support planned operating expenses into the second half of 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 September 30,								For the Nine Months Ended September 30,
		2026				2025				2026				2025
Revenue		$	—			$	—			$	—			$	4,288
Operating expenses:
Research and development			28,766				25,745				101,211				61,451
General and administrative			13,106				8,279				34,929				25,035
Net gain on lease termination			—				—				(3,433	)			—
Total operating expenses			41,872				34,024				132,707				86,486
Loss from operations			(41,872	)			(34,024	)			(132,707	)			(82,198	)
Other income (expense):
Change in fair value of warrant liability			—				(292	)			—				(463	)
Change in fair value of term loan			(1,087	)			(1,534	)			(4,078	)			(4,525	)
Interest income			3,903				3,169				8,814				6,354
Interest expense			(4	)			(15	)			(19	)			(51	)
Other expense			(68	)			(37	)			(187	)			(261	)
Total other income (expense), net			2,744				1,291				4,530				1,054
Net loss		$	(39,128	)		$	(32,733	)		$	(128,177	)		$	(81,144	)
Net loss per common share, basic and diluted		$	(0.10	)		$	(0.09	)		$	(0.34	)		$	(0.26	)
Weighted average common shares outstanding, basic and diluted			406,106,872				353,309,524				380,739,173				307,175,982

Taysha Gene Therapies, Inc.

Condensed Consolidated Balance Sheet Data

(in thousands, except share and per share data)

		September 30, 2026				December 31, 2025
ASSETS
Current assets:
Cash and cash equivalents		$	422,834			$	319,767
Restricted cash			—				449
Prepaid expenses and other current assets			3,221				4,431
Total current assets			426,055				324,647
Restricted cash			165				2,315
Property, plant and equipment, net			2,526				6,736
Operating lease right-of-use assets			6,236				9,439
Other non-current assets			48				183
Total assets		$	435,030			$	343,320
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	5,592			$	6,275
Accrued expenses and other current liabilities			17,358				20,277
Total current liabilities			22,950				26,552
Term loan, net			47,331				50,106
Operating lease liability, net of current portion			6,104				18,172
Other non-current liabilities			1,673				1,552
Total liabilities			78,058				96,382
Commitments and contingencies - Note 13
Stockholders’ equity
Preferred stock, $0.00001 par value per share; 10,000,000 shares authorized and no shares issued and outstanding as of September 30, 2026, and December 31, 2025			—				—
Common stock, $0.00001 par value per share; 700,000,000 shares authorized and 325,883,280 and 285,051,648 issued and outstanding as of September 30, 2026 and December 31, 2025, respectively			3				3
Additional paid-in capital			1,194,098				958,427
Accumulated other comprehensive income (loss)			2,348				(192	)
Accumulated deficit			(839,477	)			(711,300	)
Total stockholders’ equity			356,972				246,938
Total liabilities and stockholders’ equity		$	435,030			$	343,320

Company Contact:

investors@tayshagtx.com

Media Contact:

Media@tayshagtx.com

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 76.2 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.1 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 17.6 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.0 KB