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 third quarter ended September 30, 2022 and provided a corporate
update.
“The strategic investment from Astellas and the successfully
completed public follow-on offering have strengthened our balance
sheet and extended our cash runway into the first quarter of 2024.
The partnership with Astellas underscores the therapeutic and
market opportunity of our two lead clinical programs in GAN and
Rett syndrome. Importantly, this strategic investment further
validates our platform and our scientific approach of combining
established gene therapy technology with innovative targeted
payload design,” said RA Session II, President, Founder and CEO of
Taysha. “In 2023, we expect to provide an update on the regulatory
pathway for TSHA-120 in GAN in January following our Type B
end-of-Phase 2 meeting with the FDA. In addition, we intend to
disclose preliminary clinical data for TSHA-102 from the first
cohort of adult patients with Rett syndrome and initiate a Phase
1/2 trial for TSHA-102 in female pediatric patients with Rett
syndrome in the first half of 2023.”
Recent Corporate Highlights
Strategic investment from Astellas Pharma validates
Taysha’s scientific approach and capabilities as well as reinforces
therapeutic and market opportunity of two lead
programs
Astellas to invest a total of $50 million for 15% of Taysha to
support development of TSHA-120 in giant axonal neuropathy (GAN)
and TSHA-102 in Rett syndrome and to receive:
- An exclusive option to obtain an
exclusive license for worldwide development, manufacturing and
commercial rights to:
- TSHA-120 in GAN for a period of time
after receipt of the formal Type B end-of-Phase 2 meeting
minutes
- TSHA-102 in Rett
syndrome for a period of time after the company provides Astellas
access to certain clinical data from the female pediatric
study
- Right of first
offer related to any potential change in control of Taysha for a
period of time upon receipt of the Rett data package
- One non-voting
Board observer seat on the Taysha Board of Directors
Pricing of public offering of common stock
- On October 26,
2022, Taysha raised $28.0 million in gross proceeds through an
underwritten public offering of 14,000,000 shares of its common
stock at a price to the public of $2.00 per share.
Anticipated Upcoming Milestones
- Regulatory update for TSHA-120 in GAN following receipt of
formal meeting minutes from the Type B end-of-Phase 2 meeting with
FDA expected in mid-January 2023
- Preliminary clinical safety and efficacy data for TSHA-102 from
the entire first cohort of adult patients with Rett syndrome
expected in H1 2023
- Initiation of Phase 1/2 trial for TSHA-102 in female pediatric
patients with Rett syndrome in H1 2023
Third Quarter 2022 Financial Highlights
Research and Development (R&D) Expenses:
Research and development expenses were $16.4 million for the three
months ended September 30, 2022, compared to $39.5 million for the
three months ended September 30, 2021. The $23.1 million decrease
was attributable to a decrease of $11.7 million in research and
development GMP manufacturing and other raw material purchases.
Additionally, we incurred $6.7 million less expense in third-party
research and development consulting fees, primarily related to
non-clinical GLP toxicology studies, and a decrease of $4.7 million
in employee compensation expenses.
General and Administrative (G&A) Expenses:
General and administrative expenses were $8.7 million for the three
months ended September 30, 2022, compared to $11.2 million for the
three months ended September 30, 2021. The decrease of
approximately $2.5 million was primarily attributable to a decrease
of $1.3 million in professional fees related to
pre-commercialization, recruiting and patient advocacy activities.
Additionally, compensation expense decreased by $1.2 million
compared to the same period in 2021.
Net loss: Net loss for the three months ended
September 30, 2022, was $26.3 million, or $0.64 per share, as
compared to a net loss of $51.2 million, or $1.35 per share, for
the three months ended September 30, 2021.
Cash and cash equivalents: As of September 30,
2022, the Company had cash and cash equivalents of $34.3 million.
The Company expects that the existing cash and cash equivalents,
along with receipt of the $50.0 million payment from Astellas and
the $25.6 million proceeds net of underwriting discounts,
commissions and estimated offering expenses from the October 2022
public offering, will enable funding of operating expenses and
capital requirements into the first quarter of 2024.
Conference Call and Webcast Information
Taysha management will hold a conference call and webcast with
slides 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
855-327-6837 (U.S./Canada) or 631-891-4304 (international). The
conference ID for all callers is 10020611. 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, 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 September 30, 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.
Taysha Gene Therapies,
Inc.Condensed Consolidated Statements of
Operations(in thousands, except share and per share
data)(Unaudited)
|
|
For the Three MonthsEnded September
30, |
For the Nine MonthsEnded September
30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
16,391 |
|
|
$ |
39,528 |
|
|
$ |
77,308 |
|
|
$ |
94,025 |
|
General
and administrative |
|
|
8,683 |
|
|
|
11,153 |
|
|
|
30,019 |
|
|
|
29,518 |
|
Total
operating expenses |
|
|
25,074 |
|
|
|
50,681 |
|
|
|
107,327 |
|
|
|
123,543 |
|
Loss from operations |
|
|
(25,074 |
) |
|
|
(50,681 |
) |
|
|
(107,327 |
) |
|
|
(123,543 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest
income |
|
|
9 |
|
|
|
37 |
|
|
|
50 |
|
|
|
143 |
|
Interest
expense |
|
|
(1,241 |
) |
|
|
(543 |
) |
|
|
(3,002 |
) |
|
|
(737 |
) |
Other
expense |
|
|
(1 |
) |
|
|
- |
|
|
|
(12 |
) |
|
|
- |
|
Total
other expense, net |
|
|
(1,233 |
) |
|
|
(506 |
) |
|
|
(2,964 |
) |
|
|
(594 |
) |
Net loss |
|
$ |
(26,307 |
) |
|
$ |
(51,187 |
) |
|
$ |
(110,291 |
) |
|
$ |
(124,137 |
) |
|
|
|
|
|
|
|
|
|
Net loss per
common share, basic and diluted |
$ |
(0.64 |
) |
|
$ |
(1.35 |
) |
|
$ |
(2.77 |
) |
|
$ |
(3.31 |
) |
Weighted average
common shares outstanding, basic and diluted |
|
40,937,808 |
|
|
|
38,003,954 |
|
|
|
39,761,764 |
|
|
|
37,495,537 |
|
Taysha Gene Therapies,
Inc.Condensed Consolidated Balance Sheet
Data(in thousands, except share and per share
data)(Unaudited)
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
34,306 |
|
|
$ |
149,103 |
|
Prepaid expenses and other
current assets |
|
|
8,696 |
|
|
|
10,499 |
|
Total current assets |
|
|
43,002 |
|
|
|
159,602 |
|
Restricted cash |
|
|
2,637 |
|
|
|
2,637 |
|
Deferred lease asset |
|
|
630 |
|
|
|
667 |
|
Property, plant and equipment,
net |
|
|
63,954 |
|
|
|
50,610 |
|
Other non-current assets |
|
|
1,245 |
|
|
|
440 |
|
Total
assets |
|
$ |
111,468 |
|
|
$ |
213,956 |
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
Current liabilities |
|
|
|
|
Accounts payable |
|
$ |
15,521 |
|
|
$ |
21,763 |
|
Accrued expenses and other
current liabilities |
|
|
17,888 |
|
|
|
29,983 |
|
Total current liabilities |
|
|
33,139 |
|
|
|
51,746 |
|
Build-to-suit lease
liability |
|
|
25,496 |
|
|
|
25,900 |
|
Term Loan, net |
|
|
37,773 |
|
|
|
37,192 |
|
Other non-current
liabilities |
|
|
3,934 |
|
|
|
3,735 |
|
Total liabilities |
|
|
100,342 |
|
|
|
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 September 30, 2022 and December 31, 2021 |
|
|
- |
|
|
|
- |
|
Common stock, $0.00001 par
value per share; 200,000,000 shares authorized and 41,175,939 and
38,473,945 issued and outstanding as of September 30, 2022 and
December 31, 2021, respectively |
|
|
1 |
|
|
|
- |
|
Additional paid-in
capital |
|
|
357,065 |
|
|
|
331,032 |
|
Accumulated deficit |
|
|
(345,940 |
) |
|
|
(235,649 |
) |
Total stockholders’
equity |
|
|
11,126 |
|
|
|
95,383 |
|
Total liabilities and
stockholders' equity |
|
$ |
111,468 |
|
|
$ |
213,956 |
|
Company Contact:Kimberly Lee, D.O. Chief
Corporate Affairs OfficerTaysha Gene
Therapiesklee@tayshagtx.com
Media Contact:Carolyn HawleyEvoke
Canalecarolyn.hawley@evokegroup.com
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