8-K
false 0001806310 0001806310 2022-05-16 2022-05-16

 

 

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 16, 2022

 

 

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 16, 2022, Taysha Gene Therapies, Inc. (the “Company”) reported financial results and business highlights for the quarter ended March 31, 2022. 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 16, 2022.
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: May 16, 2022     By:  

/s/ Kamran Alam

      Kamran Alam
      Chief Financial Officer
EX-99.1

Exhibit 99.1

 

LOGO

Taysha Gene Therapies Reports First Quarter 2022 Financial Results and Provides Corporate Update

Initiated clinical development of TSHA-102 for Rett Syndrome under recently approved Clinical Trial Application (CTA) with preliminary Phase 1/2 data expected by year-end 2022

Received Orphan Drug Designation from the European Commission for TSHA-120 for giant axonal neuropathy (GAN) and recently completed commercially representative GMP batch; regulatory update expected in mid-2022

Existing cash and cash equivalents, along with full access to the term loan facility, is expected to fund operating expenses and capital requirements into the fourth quarter of 2023

Dallas – May 16, 2022 - Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric, pivotal-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS) in both rare and large patient populations, today reported financial results for the first quarter ended March 31, 2022 and provided a corporate update.

“In 2022, we are focused on advancing our key programs in Rett syndrome and GAN. We initiated clinical development of TSHA-102 in Rett syndrome and expect preliminary clinical data from the REVEAL study by year-end,” said RA Session II, President, Founder and CEO of Taysha. “Recently, the European Commission granted orphan drug designation for TSHA-120 for GAN, further highlighting the unmet need for treatment options for these patients and the important potential of TSHA-120. We have completed a commercially representative GMP batch for TSHA-120 with release testing currently underway. Our existing capital resources, along with full access to the term loan facility, should fund operating expenses and capital requirements into the fourth quarter of 2023.”

Recent Corporate Highlights

TSHA-120 for giant axonal neuropathy (GAN): an intrathecally dosed AAV9 gene therapy currently being evaluated in a clinical trial for the treatment of GAN, a rare inherited genetic disorder that affects both the central and peripheral nervous systems and is caused by loss-of-function mutations in the gene coding for gigaxonin. TSHA-120 is designed to deliver a functional copy of the GAN gene to the CNS and PNS. TSHA-120 has already received orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration (FDA) and orphan drug designation from the European Commission.


LOGO

 

   

Received orphan drug designation from the European Commission for GAN in April 2022

 

   

Reported positive clinical efficacy and safety data for high dose cohort and long-term durability data across all therapeutic dose cohorts for TSHA-120 in GAN

 

   

Efficacy data for high dose cohort demonstrated clinically meaningful and statistically significant improvement in MFM32 by Year 1 compared to natural history (n=3)

 

   

Long-term durability data across all therapeutic dose cohorts demonstrated a 10-point improvement in mean change in MFM32 by Year 3 compared to estimated natural history decline of 24 points (n=5)

 

   

Biopsy data in five of six patient samples analyzed to date confirmed active regeneration of nerve fibers following treatment with TSHA-120 (n=6)

 

   

53 patient-years of clinical data support the safety and tolerability profile of TSHA-120

 

   

Commercially representative GMP batch completed and release testing underway

 

   

Regulatory feedback for TSHA-120 in GAN expected mid-2022

TSHA-102 in Rett syndrome: a self-complementary intrathecally delivered AAV9 gene replacement therapy under development for the treatment of Rett syndrome. TSHA-102 utilizes the novel miRARE platform to regulate transgene expression genotypically on a cell-by-cell basis. TSHA-102 is the first-and-only gene therapy in clinical development for Rett syndrome. TSHA-102 has received orphan drug and rare pediatric disease designations from the FDA and has been granted orphan drug designation from the European Commission.

 

   

CTA approved by Health Canada in March 2022

 

   

Published preclinical data for TSHA-102 in Rett syndrome presented at the International Rett Syndrome Foundation (IRSF) Rett Syndrome Scientific Meeting and the ASCEND Rett Syndrome National Summit in April 2022

 

   

Initiation of clinical development with the REVEAL study, an open-label, dose escalation, randomized, multicenter Phase 1/2 clinical trial in adult female patients with Rett syndrome

 

   

Sainte-Justine Mother and Child University Hospital Center in Montreal, Quebec, Canada selected as the initial clinical site under the direction of Dr. Elsa Rossignol, principal investigator

 

   

Key assessments to include Rett-specific and global assessments, quality of life, biomarkers and neurophysiology and imaging

 

   

Preliminary clinical data for TSHA-102 in Rett syndrome expected by year-end 2022

AAV9 Gene Replacement for CLN7 Batten disease: an investigational AAV9 intrathecally dosed gene replacement therapy designed to deliver a full-length copy of the CLN7 gene to potentially treat CLN7 disease, a rapidly progressing rare lysosomal storage disease with no approved treatments. The clinical development of the CLN7 program is being funded by UT Southwestern (UTSW), Children’s Health and Children’s Medical Center Foundation.

 

   

Reported positive preliminary clinical safety data for first-generation construct in CLN7 Batten disease from UTSW-sponsored clinical trial

 

   

Data from three patients dosed presented at the 18th Annual WORLDSymposium

 

   

Fourth patient with CLN7 disease dosed at 1.0 x 1015 total vg


LOGO

 

Anticipated Milestones

 

   

Regulatory update for TSHA-120 in GAN by mid-2022

 

   

Preliminary clinical data from the REVEAL study for TSHA-102 in Rett syndrome by year-end 2022

 

   

Initiation of clinical development for TSHA-105 in SLC13A5 deficiency

 

   

Continued clinical development of the first-generation construct for CLN7 disease in 2022

 

   

Continued clinical development for TSHA-118 in CLN1 disease

First Quarter Financial Highlights

Research and Development (R&D) Expenses: Research and development expenses were $37.8 million for the three months ended March 31, 2022, compared to $23.9 million for the three months ended March 31, 2021. The increase of approximately $13.9 million was primarily attributable to an increase of $9.3 million in employee compensation, which included $2.2 million of severance and one-time termination costs in connection with the strategic reprioritization of programs completed in March 2022 and $1.0 million of non-cash stock-based compensation. Additionally, in the three months ended March 31, 2022 we incurred an increase of $2.9 million of expenses in research and development manufacturing and other raw material purchases. We also incurred an increase of $1.7 million of third-party research and development consulting fees, primarily related to GLP toxicology studies and clinical study activities.

General and Administrative (G&A) Expenses: General and administrative expenses were $11.5 million for the three months ended March 31, 2022, compared to $8.2 million for the three months ended March 31, 2021. The increase of approximately $3.3 million was primarily attributable to $2.9 million of incremental compensation expense, which included $0.4 million of severance and one-time termination costs and $0.7 million of non-cash stock-based compensation. We also incurred an increase of $0.4 million in professional fees related to insurance, investor relations/communications, accounting, and market research.

Net loss: Net loss for the three months ended March 31, 2022 was $50.1 million, or $1.31 per share, as compared to a net loss of $32.0 million, or $0.87 per share, for the three months ended March 31, 2021.

Cash and cash equivalents: As of March 31, 2022, we had $96.6 million in cash and cash equivalents. This excludes approximately $12 million in gross proceeds generated from the sale of common stock, par value $0.00001 per share, under our existing at-the-market facility in April 2022.

Conference Call and Webcast Information

Taysha management will hold a conference call and webcast today at 8:00 am ET / 7:00 am CT to review its financial and operating results and to provide a corporate update. The dial-in number for the conference call is 877-407-0792 (U.S./Canada) or 201-689-8263 (international). The conference ID for all callers is 13729044. The live webcast and replay may be accessed by visiting Taysha’s website at https://ir.tayshagtx.com/news-events/events-presentations. An archived version of the webcast will be available on the website for 30 days.


LOGO

 

About Taysha Gene Therapies    

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our team’s proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platform—an engine for potential new cures—with a goal of dramatically improving patients’ lives. More information is available at 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 statements concerning the potential of our product candidates, including our preclinical product candidates, to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the potential for these 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, the potential market opportunity for these product candidates, our corporate growth plans, the forecast of our cash runway and the implementation and potential impacts of our strategic pipeline prioritization initiatives. 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 our business are described in detail in our Securities and Exchange Commission (“SEC”) filings, including in our Annual Report on Form 10-K for the full-year ended December 31, 2021 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, both of which are available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.


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Taysha Gene Therapies, Inc.

Condensed Consolidated Statements of Operations

(in thousands, except share and per share data)

(Unaudited)

 

     For the Three Months
Ended March 31,
 
     2022     2021  

Operating expenses:

    

Research and development

   $ 37,799     $ 23,854  

General and administrative

     11,469       8,236  
  

 

 

   

 

 

 

Total operating expenses

     49,268       32,090  
  

 

 

   

 

 

 

Loss from operations

     (49,268     (32,090

Other income (expense):

    

Interest income

     14       66  

Interest expense

     (849     —    

Other expense

     (8     —    
  

 

 

   

 

 

 

Total other expense, net

     (843     66  
  

 

 

   

 

 

 

Net loss

   $ (50,111   $ (32,024
  

 

 

   

 

 

 

Net loss per common share, basic and diluted

   $ (1.31   $ (0.87
  

 

 

   

 

 

 

Weighted average common shares outstanding, basic and diluted

     38,174,717       36,992,377  
  

 

 

   

 

 

 


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Taysha Gene Therapies, Inc.

Condensed Consolidated Balance Sheet Data

(in thousands, except share and per share data)

(Unaudited)

 

     March 31,
2022
    December 31,
2021
 

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 96,630     $ 149,103  

Prepaid expenses and other current assets

     10,261       10,499  
  

 

 

   

 

 

 

Total current assets

     106,891       159,602  
  

 

 

   

 

 

 

Restricted cash

     2,637       2,637  

Deferred lease asset

     655       667  

Property, plant and equipment, net

     55,120       50,610  

Other non-current assets

     673       440  
  

 

 

   

 

 

 

Total assets

   $ 165,976     $ 213,956  
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities

    

Accounts payable

   $ 21,997     $ 21,763  

Accrued expenses and other current liabilities

     26,620       29,983  
  

 

 

   

 

 

 

Total current liabilities

     48,617       51,746  

Build-to-suit lease liability

     25,752       25,900  

Term Loan, net

     37,386       37,192  

Other non-current liabilities

     3,496       3,735  
  

 

 

   

 

 

 

Total liabilities

     115,251       118,573  
  

 

 

   

 

 

 

Stockholders’ equity

    

Preferred stock, $0.00001 par value per share; 10,000,000 shares authorized and no shares issued and outstanding as of March 31, 2022 and December 31, 2021

     —         —    

Common stock, $0.00001 par value per share; 200,000,000 shares authorized and 38,473,945 issued and outstanding as of March 31, 2022 and December 31, 2021

     —         —    

Additional paid-in capital

     336,485       331,032  

Accumulated deficit

     (285,760     (235,649
  

 

 

   

 

 

 

Total stockholders’ equity

     50,725       95,383  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 165,976     $ 213,956  
  

 

 

   

 

 

 


LOGO

 

Company Contact:

Kimberly Lee, D.O.

Chief Corporate Affairs Officer

Taysha Gene Therapies

klee@tayshagtx.com

Media Contact:

Carolyn Hawley

Canale Communications

carolyn.hawley@canalecomm.com