Turnstone Biologics Corp. Reports Second Quarter 2023 Financial Results and Provides Business Update
01 Settembre 2023 - 11:57PM
Turnstone Biologics Corp. (“Turnstone” or the “Company”) (Nasdaq:
TSBX), a clinical-stage biotechnology company developing new
medicines to treat and cure solid tumors by pioneering a
differentiated approach to tumor-infiltrating lymphocyte (TIL)
therapy, today announced financial results for the second quarter
ended June 30, 2023, and provided an update on recent business
highlights.
“I am extremely proud of the recent achievements
of the Turnstone team, including the successful completion of our
upsized IPO which, despite challenging current market conditions,
is indicative of the potential for Turnstone to deliver
transformative therapies to the millions of cancer patients
underserved by current treatment options,” said Sammy Farah, Ph.D.,
M.B.A., Turnstone’s President and Chief Executive Officer. “We are
thrilled to bring in new investors through our upsized IPO and to
have the continued support of our existing stockholders. With the
additional funding and the deeply experienced and dynamic team we
have assembled at the Company, Turnstone is strongly positioned to
execute on our lead clinical candidate, TIDAL-01, and continue
advancing our next-generation Selected TIL therapy pipeline.”
Recent Business Highlights
-
Completed Upsized Initial Public Offering: In July
2023, Turnstone priced its initial public offering (IPO) at $12.00
per share. In connection with the offering, the Company issued
7,318,275 common shares, including 651,608 shares sold in August
2023 pursuant to the exercise of the underwriters’ option to
purchase additional shares, and received gross proceeds of
approximately $88.0 million before deducting underwriting discounts
and commissions and other offering expenses. The shares began
trading on the Nasdaq Global Market on July 21, 2023, under the
ticker symbol “TSBX”.
Clinical Development and Pre-Clinical
Data
-
Advancing TIDAL-01 in Two Phase 1 Clinical Trials:
Turnstone’s lead Selected TIL product candidate, TIDAL-01, utilizes
an unbiased identification and functional screening process to
isolate and selectively expand the greatest breadth of
tumor-reactive TILs from the patient’s tumor that we believe can
extend the utility of TILs to solid tumor types where
first-generation TILs have not to date shown objective responses in
clinical trials. We have initiated two Phase 1 clinical trials for
TIDAL-01, including STARLING, a multi-site trial for the treatment
of breast cancer, colorectal cancer and uveal melanoma, and an
investigator-sponsored trial with H. Lee Moffitt Cancer Center and
Research Institute in both cutaneous and non-cutaneous melanomas.
We expect to provide an initial clinical update across these two
trials in mid-2024.
-
Preclinical Data at AACR 2023 Annual Meeting Supporting
Ongoing Clinical Efforts: In April 2023, Turnstone
presented at the American Association for Cancer Research (AACR)
Annual Meeting pre-clinical data on TIDAL-01. Relative to bulk TIL,
the data demonstrated that TIDAL-01 successfully enriched for
tumor-reactive TIL in metastatic colorectal cancer, melanoma,
non-small lung cancer and ovarian tumors, and these results further
support continued advancement of the Company’s lead Selected TIL
program in the ongoing STARLING and Moffitt-sponsored clinical
trials. In addition, Turnstone presented pre-clinical data from its
development pipeline showcasing a novel strategy to efficiently
directly select and expand tumor-reactive TIL.
Second Quarter 2023 Financial
Results
- Cash,
Cash Equivalents and Short-Term Investments: As of June
30, 2023, cash, cash equivalents and short-term investments were
$49.2 million. The Company’s subsequent IPO in the third quarter of
2023 raised $77.4 million in net proceeds after deducting
underwriting discounts and commissions and other offering expenses.
The Company expects that the combined cash, cash equivalents and
short-term investments will be sufficient to fund its operations
into the second quarter of 2025.
- Research
and Development (R&D) Expenses: R&D expenses for
the three months ended June 30, 2023, were $17.2 million, compared
to $26.5 million for the same period in 2022. The decrease was due
primarily to a decrease in pre-clinical research costs and
manufacturing expenses due to the termination of the discovery,
collaboration and license agreement entered into on November 7,
2019, with Takeda Oncology for certain viral immunotherapy
candidates offset by increases in personnel-related costs, and in
clinical and regulatory costs.
- General
and Administrative (G&A) Expenses: G&A expenses
for the three months ended June 30, 2023, were $4.7 million,
compared to $3.9 million for the same period in 2022. The increase
was due primarily to an increase in professional services and
compensation as we transition to being a public company.
- Net
Loss: Net loss for the three months ended June 30, 2023,
was $21.5 million, compared to net income of $11.6 million for the
second quarter of 2022.
About Turnstone
Turnstone Biologics is a clinical-stage
biotechnology company developing new medicines to treat and cure
solid tumors by pioneering a differentiated approach to TIL
therapy. Turnstone’s innovative TIL therapy is based upon the
identification, selection, and expansion of the most potent
tumor-reactive T cells, known as Selected TILs, and is designed to
overcome the limitations of first-generation bulk TILs that have
demonstrated objective responses only in limited tumor types.
Turnstone’s most advanced program, TIDAL-01, is currently being
evaluated in two Phase 1 studies in patients with melanoma, breast
cancer and colorectal cancer, and the Company is also actively
advancing its preclinical pipeline programs including TIDAL-02, its
next Selected TIL program, and its TIDAL-01 and viral immunotherapy
combination program. For additional information about Turnstone,
please visit www.turnstonebio.com, and follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking
statements including, but not limited to, statements related to
Turnstone’s expectations regarding its cash runway; the potential
for Turnstone to deliver transformative therapies to the millions
of cancer patients underserved by current treatment options;
anticipated development activities; the therapeutic potential of
Turnstone’s product candidates; and other statements that are not
historical fact. These forward-looking statements are based on
Turnstone’s current plans, objectives and projections, and are
inherently subject to risks and uncertainties that may cause
Turnstone’s actual results to materially differ from those
anticipated in such forward-looking statements. Such risks and
uncertainties include, without limitation, those associated with
the successful completion of development and regulatory activities
with respect to Turnstone’s product candidates; maintaining and
defending intellectual property protection; delays or failures to
secure adequate supply of its product candidates; legal
proceedings, government investigations or other actions;
macroeconomic conditions; market volatility; and other risks and
uncertainties affecting Turnstone including those described from
time to time under the caption “Risk Factors” and elsewhere in
Turnstone’s current and future reports filed with the Securities
and Exchange Commission, including its Quarterly Report on Form
10-Q for the quarter ended June 30, 2023. Forward-looking
statements contained in this press release are made as of this
date, and Turnstone undertakes no duty to update such information
except as required under applicable law.
|
Condensed Consolidated Balance Sheet (unaudited) (In
thousands) |
|
June 30, 2023 |
December 31, 2022 |
|
|
|
Cash and cash equivalents and short-term investments |
$ |
49,236 |
|
$ |
82,061 |
|
Total
assets |
|
74,771 |
|
|
114,938 |
|
Total
liabilities |
|
23,393 |
|
|
44,461 |
|
Total
redeemable convertible preferred stock |
|
171,983 |
|
|
171,944 |
|
Total
stockholders' deficit |
|
(120,605 |
) |
|
(101,467 |
) |
|
|
|
|
Condensed Consolidated Statement of Operations and
Comprehensive Income (Loss) (unaudited) (In thousands, except share
and per share data) |
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Collaboration revenue |
$ |
- |
|
|
$ |
41,915 |
|
|
$ |
19,306 |
|
|
$ |
52,633 |
|
Operating
expenses |
|
|
|
|
|
|
|
Research and development |
|
17,193 |
|
|
|
26,537 |
|
|
|
32,861 |
|
|
|
45,238 |
|
General and administrative |
|
4,659 |
|
|
|
3,932 |
|
|
|
8,691 |
|
|
|
8,630 |
|
Total
operating expenses |
|
21,852 |
|
|
|
30,469 |
|
|
|
41,552 |
|
|
|
53,868 |
|
Income
(loss) from operations |
|
(21,852 |
) |
|
|
11,446 |
|
|
|
(22,246 |
) |
|
|
(1,235 |
) |
Other income
(expense), net |
|
347 |
|
|
|
180 |
|
|
|
727 |
|
|
|
265 |
|
Net income
before income taxes |
|
(21,505 |
) |
|
|
11,626 |
|
|
|
(21,519 |
) |
|
|
(970 |
) |
Benefit
(provision) for income taxes |
|
6 |
|
|
|
(26 |
) |
|
|
88 |
|
|
|
(46 |
) |
Net income
(loss) |
$ |
(21,499 |
) |
|
$ |
11,600 |
|
|
$ |
(21,431 |
) |
|
$ |
(1,016 |
) |
Other
comprehensive income (loss) |
|
59 |
|
|
|
(81 |
) |
|
|
180 |
|
|
|
(175 |
) |
Total
comprehensive income (loss) |
$ |
(21,440 |
) |
|
$ |
11,519 |
|
|
$ |
(21,251 |
) |
|
$ |
(1,191 |
) |
Net income
(loss) |
$ |
(21,499 |
) |
|
$ |
11,600 |
|
|
$ |
(21,431 |
) |
|
$ |
(1,016 |
) |
Less:
accretion of preferred stock to redemption value |
$ |
(19 |
) |
|
$ |
(57 |
) |
|
$ |
(39 |
) |
|
$ |
(114 |
) |
Less:
undistributed earnings allocable to participating securities |
$ |
- |
|
|
$ |
(10,355 |
) |
|
$ |
- |
|
|
$ |
- |
|
Net income
(loss) attributable to common stockholder, basic and diluted |
$ |
(21,518 |
) |
|
$ |
1,188 |
|
|
$ |
(21,470 |
) |
|
$ |
(1,130 |
) |
Weighted-average number of shares used in computing net earnings
(loss) per share |
|
|
|
|
|
|
|
Basic |
|
2,847,675 |
|
|
|
2,355,553 |
|
|
|
2,817,008 |
|
|
|
2,317,631 |
|
Diluted |
|
2,847,675 |
|
|
|
2,827,238 |
|
|
|
2,817,008 |
|
|
|
2,317,631 |
|
|
|
|
|
|
|
|
|
Net income
(loss) per share attributable to common stockholders |
|
|
|
|
|
|
|
Basic |
$ |
(7.56 |
) |
|
$ |
0.50 |
|
|
$ |
(7.62 |
) |
|
$ |
(0.49 |
) |
Diluted |
$ |
(7.56 |
) |
|
$ |
0.42 |
|
|
$ |
(7.62 |
) |
|
$ |
(0.49 |
) |
|
|
|
|
|
|
|
|
Contact
Ahmed AneiziTurnstone Biologics+1 (613)
421-8930ahmed.aneizi@turnstonebio.com
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