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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Taysha Gene Therapies Inc | NASDAQ:TSHA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.01 | 0.32% | 3.10 | 3.07 | 3.10 | 3.17 | 3.05 | 3.09 | 806,115 | 23:36:46 |
Positive pre-IND/CTA feedback obtained from several key regulatory agencies for TSHA-102 in Rett syndrome, TSHA-101 in GM2 gangliosidosis and TSHA-118 in CLN1 disease, paving the way for multiple anticipated IND/CTA filings in the second half of 2021
Entered into a non-dilutive term loan agreement with Silicon Valley Bank that provides up to $100 million in tranches at an attractive interest rate that lowers overall cost of capital, strengthens the balance sheet and offers additional financial and operational flexibility; assuming full drawdown, cash runway expected to be sufficient to achieve potential regulatory approval for TSHA-120 in GAN without the need for additional financing
Reiterate guidance for clinical, regulatory and preclinical milestones in second half of 2021, including Phase 1/2 data from the highest dose cohort of TSHA-120 study in GAN, regulatory update for GAN program, preliminary Phase 1/2 safety and biomarker data for TSHA-101 in GM2 gangliosidosis, and initiation of Phase 1/2 trials in CLN1 disease, Rett syndrome and SURF1-associated Leigh syndrome
Numerous successful GMP runs provided sufficient drug products to support five planned Phase 1/2 trials and multiple programs in IND/CTA-enabling studies in the second half of 2021
Recent publications of GAN natural history data for TSHA-120 and positive preclinical data for TSHA-102 in Rett syndrome in the journal Brain provide further support of clinical development strategies
Completed first R&D and manufacturing investor days highlighting preclinical and clinical data from multiple programs, the company’s unique three-pillar approach to manufacturing and its capabilities, the regulatory environment for gene therapy manufacturing, and the immunology of gene therapy
Upcoming virtual investor mini-series for CLN1, Rett and Angelman syndrome programs to feature Key Opinion Leaders and highlight progress across these programs
Conference call and live webcast today at 8:00 a.m. Eastern Time
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 second quarter ended June 30, 2021 and provided a corporate update.
“We continue to make significant progress on several key clinical, manufacturing and strategic corporate initiatives which were highlighted in our R&D and Manufacturing investor days and in our recent press release announcing our non-dilutive financing with SVB,” noted RA Session II, President, Founder and CEO of Taysha. “We have received positive pre-IND/CTA feedback from several key regulatory agencies for our Rett syndrome, GM2 gangliosidosis and CLN1 disease programs, which pave the way for multiple expected IND/CTA filings and clinical trial initiations in the second half of the year. Our success relies on robust, sustainable and high-quality manufacturing to support our portfolio, and we have completed numerous successful GMP runs to support five planned Phase 1/2 trials and several programs in IND/CTA-enabling studies. With ambitious corporate objectives planned over the next 12 to 18 months, we are pleased to have recently entered into a loan agreement for up to $100 million at an attractive interest rate which lowers overall cost of capital and contains no financial covenants or warrants. The initial draw bolsters our cash position and provides financial and operational flexibility. We believe full drawdown of this non-dilutive financing will extend our cash runway to support key value-creating milestones, including the release of Phase 1/2 data from the highest dose cohort in GAN, and Phase 1/2 data in GM2 gangliosidosis, Rett syndrome, CLN1 disease and SURF1-associated Leigh syndrome and, importantly, a potential regulatory approval for TSHA-120 in GAN without the need for additional financing. We look forward to updating you on our continued progress throughout the year.”
Recent Corporate Highlights
Anticipated Milestones by Program
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-101 for GM2 gangliosidosis: the first bicistronic gene therapy in clinical development designed to deliver two genes – HEXA and HEXB, comprising the alpha and beta sub-units of Beta Hexoseaminidase A, intrathecally for the treatment of GM2 gangliosidosis, also called Tay-Sachs or Sandhoff disease
TSHA-118 in CLN1: a self-complementary AAV9 viral vector designed to express a human codon-optimized CLN1 transgene to potentially treat CLN1, a rapidly progressing rare lysosomal storage disease with no approved treatments
TSHA-102 in Rett syndrome: a self-complementary AAV9 gene therapy in development for a severe neurodevelopmental disorder, designed to deliver MECP2, as well as a novel miRARE platform that regulates transgene expression on a cell-by-cell basis
TSHA-104 in SURF1-associated Leigh syndrome: a self-complementary AAV9 viral vector with a transgene encoding the human SURF1 protein to potentially treat SURF1-associated Leigh syndrome, a monogenic mitochondrial disorder with no approved treatments
Pipeline programs in IND/CTA-enabling studies
Discovery programs
Next-generation technology platform
Second Quarter 2021 Financial Highlights
Research and Development (R&D) Expenses: Research and development expenses were $30.6 million for the three months ended June 30, 2021, compared to $3.1 million for the three months ended June 30, 2020. The $27.5 million increase was primarily attributable to an increase of $10.3 million of expenses incurred in research and development manufacturing and other raw material purchases, which included cGMP batches produced by Catalent and UT Southwestern. We incurred an increase in employee compensation expenses of $8.5 million, which included $2.2 million of non-cash stock-based compensation, and $8.7 million in third-party research and development expenses, which includes clinical trial CRO activities, GLP toxicology studies, and consulting for regulatory and clinical studies.
General and Administrative (G&A) Expenses: General and administrative expenses were $10.1 million for the three months ended June 30, 2021, compared to $0.9 million for the three months ended June 30, 2020. The increase was primarily attributable to incremental compensation expense, which included non-cash stock-based compensation, and additional consulting and professional fees.
Net loss: Net loss for the second quarter ended June 30, 2021 was $40.9 million or $1.09 per share, as compared to a net loss of $21.2 million, or $1.95 per share, for the second quarter ended June 30, 2020.
Cash and cash equivalents: As of June 30, 2021, Taysha had $197.4 million in cash and cash equivalents.
Conference Call and Webcast Information
Taysha management will hold a conference call and webcast today at 8:00 a.m. ET / 7:00 a.m. 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 13722197. 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.
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 and our plans to establish a commercial-scale cGMP manufacturing facility to provide preclinical, clinical and commercial supply and our anticipated cash runway assuming full access to the $100 million potentially available under the loan and security agreement. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission (“SEC”) filings, including in our Annual Report on Form 10-K for the full-year ended December 31, 2020 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, both of which are available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.
Taysha Gene Therapies, Inc.
Consolidated Statements of Operations
(in thousands, except share and per share data)
(Unaudited)
For the Three MonthsEnded June 30, For the Six MonthsEnded June 30,2021
2020
2021
2020
Operating expenses: Research and development$
30,643
$
3,062
$
54,497
$
8,576
General and administrative
10,129
948
18,365
1,018
Total operating expenses
40,772
4,010
72,862
9,594
Loss from operations
(40,772
)
(4,010
)
(72,862
)
(9,594
)
Other income (expense): Change in fair value of preferred stock tranche liability
-
(17,210
)
-
(17,030
)
Interest income
40
-
106
-
Interest expense
(194
)
-
(194
)
(27
)
Total other expense, net
(154
)
(17,210
)
(88
)
(17,057
)
Net loss$
(40,926
)
$
(21,220
)
$
(72,950
)
$
(26,651
)
Net loss per common share, basic and diluted$
(1.09
)
$
(1.95
)
$
(1.96
)
$
(2.45
)
Weighted average common shares outstanding, basic and diluted
37,479,164
10,894,999
37,237,115
10,894,999
Taysha Gene Therapies, Inc.
Consolidated Balance Sheet Data
(in thousands, except share and per share data)
(Unaudited)
June 30,2021 December 31,2020 ASSETS Current assets: Cash and cash equivalents$
197,370
$
251,253
Prepaid expenses and other current assets
9,932
6,626
Total current assets
207,302
257,879
Deferred lease asset
691
715
Property, plant and equipment, net
33,867
287
Total assets
$
241,860
$
258,881
LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable
$
6,355
$
1,994
Accrued expenses and other current liabilities
22,036
5,135
Total current liabilities
28,391
7,129
Build-to-suit lease liability
26,209
-
Other non-current liabilities
765
450
Total liabilities
55,365
7,579
Stockholders' equity Preferred stock, $0.00001 par value per share; 10,000,000 sharesauthorized and no shares issued and outstanding as of June 30, 2021and December 31, 2020
-
-
Common stock, $0.00001 par value per share; 200,000,000 sharesauthorized and 38,391,165 and 37,761,435 issued and outstanding as ofJune 30, 2021 and December 31, 2020, respectively
-
-
Additional paid-in capital
320,571
312,428
Accumulated deficit
(134,076
)
(61,126
)
Total stockholders’ equity
186,495
251,302
Total liabilities and stockholders' equity
$
241,860
$
258,881
View source version on businesswire.com: https://www.businesswire.com/news/home/20210816005196/en/
Company Contact: Kimberly Lee, D.O. SVP, Corporate Communications and Investor Relations Taysha Gene Therapies klee@tayshagtx.com
Media Contact: Carolyn Hawley Canale Communications carolyn.hawley@canalecomm.com
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