Turnstone Biologics Corp. (“Turnstone” or the “Company”)
(Nasdaq: TSBX), a clinical-stage biotechnology company
developing a differentiated approach to treat and cure patients
with solid tumors by pioneering selected tumor-infiltrating
lymphocyte (Selected TIL) therapy, today reported financial results
for the fourth quarter and full year ended December 31, 2023, and
provided recent business highlights.
“2023 marked a transformative year for Turnstone
Biologics in which we transitioned into a publicly traded company
and continued to advance our pipeline through clinical development.
We are encouraged by the increasing momentum in the TIL landscape
that paves the way for next-generation approaches like our Selected
TIL therapy, which is designed to create a TIL product with a
significantly greater population of potent tumor-reactive T cells,
which we believe is the key to extending their therapeutic
potential to high unmet medical needs in solid tumors beyond
melanoma,” said Sammy Farah, M.B.A., Ph.D., Turnstone’s President
and Chief Executive Officer. “In 2024, we look forward to
generating clinical data that potentially highlights the
differentiation of our platform and supports further development of
our lead asset, TIDAL-01, which is currently being evaluated in
Phase 1 studies in patients with colorectal cancer, head and neck
squamous cell carcinoma, breast cancer, uveal melanoma, and
cutaneous melanoma. We remain on-track to share initial clinical
data for TIDAL-01 in mid-2024 and we believe we are well-positioned
for another year of meaningful progress for our organization.”
Fourth Quarter and Recent Business
Highlights
Advancing TIDAL-01 in Multiple Phase 1 Clinical Trials
and Expanding of Targeted Solid Tumor Indications.
TIDAL-01 employs an unbiased identification and functional
screening process to isolate and selectively expand the greatest
breadth of tumor-reactive TILs from the patient’s tumor. Turnstone
believes TIDAL-01 can expand the utility of TIL therapy to solid
tumor types where first-generation TILs have not to date shown
objective responses in clinical trials and is pursuing several
indications with critical unmet need, potentially enabling
meaningful therapeutic differentiation. Recently, Turnstone
expanded their trials to evaluate additional solid tumor types in
addition to the existing indications of breast cancer and uveal
melanoma. The multi-site STARLING trial protocol has been amended
to cover head and neck squamous cell carcinoma (HNSCC), and the H.
Lee Moffitt Cancer Center and Research Institute sponsored trial
has been expanded to include colorectal cancer (CRC) and HNSCC.
Turnstone expects to provide an initial clinical update across
these trials in mid-2024.
Preclinical Data Presentations at the 2023 Society for
Immunotherapy of Cancer (SITC) Annual Meeting Support Ongoing
Clinical and Preclinical Efforts. In November 2023,
Turnstone presented preclinical data on its Selected TIL therapies,
including the demonstration of the feasibility of selecting and
expanding tumor-reactive TIL as further evidence for the potential
of TIDAL-01 as a treatment option for patients with colorectal and
gastric cancers. Turnstone also presented on its next Selected TIL
program from its development pipeline, TIDAL-02, which seeks to
utilize a novel direct selection method, genetically engineered to
rapidly select for the greatest breadth of tumor-reactive T
cells.
Strengthened Company’s Scientific Advisory
Board. In October 2023, Turnstone appointed Jeffrey S.
Weber, M.D., Ph.D., to its Scientific Advisory Board. Dr. Weber, a
world-renowned thought leader with extensive experience in
innovative immunotherapies for solid tumors, currently serves as
Deputy Director of the Perlmutter Cancer Center and Co-Director of
the Melanoma Research Program at the New York University-Langone
Cancer Center.
Fourth Quarter 2023 Financial Results
Cash, Cash Equivalents and Short-Term
Investments: As of December 31, 2023, cash, cash
equivalents and short-term investments were $94.8 million. 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
December 31, 2023, were $13.6 million, compared to $20.2 million
for the same period in 2022. The decrease was due primarily to
decreases in pre-clinical and regulatory costs, personnel-related
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 an increase due to ramp up of
TIDAL-01 activities.
General and Administrative (G&A) Expenses:
G&A expenses for the three months ended December 31, 2023, were
$4.4 million, compared to $4.4 million for the same period in
2022.
Net Loss: Net loss for the three months ended
December 31, 2023, was $16.5 million, compared to net loss of $13.7
million for the same period in 2022.
Full Year 2023 Financial
Results
Cash, Cash Equivalents and Short-Term
Investments: For the full year ended December 31, 2023,
cash, cash equivalents and short-term investments were $94.8
million.
Research and Development (R&D)
Expenses: R&D expenses for the full year ended
December 31, 2023, were $60.5 million, compared to $86.7 million
for the prior year period. The decrease was due primarily to
decreases in pre-clinical and regulatory 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 an increase in
personnel-related costs and costs due to ramp up of TIDAL-01
activities.
General and Administrative (G&A)
Expenses: G&A expenses for the full year ended
December 31, 2023, were $17.8 million, compared to $18.2 million
for the prior year period. We anticipate that G&A expenses will
remain stable as we support public company operations.
Net Loss: Net loss for the full
year ended December 31, 2023, was $55.2 million, compared to net
loss of $30.8 million for the prior year period.
About Turnstone
Turnstone Biologics is a clinical-stage
biotechnology company developing a differentiated approach to treat
and cure patients with solid tumors by pioneering selected
tumor-infiltrating lymphocyte (Selected TIL) therapy. Turnstone’s
next-generation 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 TIL that have demonstrated objective
responses only in limited tumor types. Turnstone’s most advanced
program, TIDAL-01, is currently being evaluated in multiple Phase 1
studies in patients with colorectal cancer, breast cancer, head and
neck cancer, uveal melanoma, and cutaneous melanoma. 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 within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements expressed or implied
in this press release include, but are not limited to, statements
regarding: the potential for TIDAL-01 and other pipeline programs
to achieve objective responses in solid tumors; the potential for
Turnstone’s Selected TILs to efficiently select and expand
tumor-reactive TIL to and to effectively apply current TIL
therapies across a wider range of solid tumors; the potential of
TIDAL-01 as a treatment option for patients with colorectal and
gastric cancer; Turnstone’s projected cash runway into the second
quarter of 2025; and Turnstone’s strategies and objectives. All
statements, other than statements of historical fact, contained in
this press release, including statements regarding future events,
future financial performance, business strategy and plans, and
objectives for future operations, are forward-looking statements
and can be identifies by terminology such as “anticipate,”
“believe,” “contemplate,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will” or “would,” or the negative
of these terms or other comparable terminology. These statements
are based on the current plans, objectives, estimates, expectations
and intentions, beliefs and assumptions of our management team, and
on information currently available to such management team and are
not guarantees of future performance and inherently involve
numerous risks and uncertainties, many of which are beyond
Turnstone’s control. We undertake no obligation to update or revise
publicly any of the forward-looking statements after the date
hereof to conform the statements to actual results or changed
expectations except as required by law. The reader is cautioned not
to place undue reliance on forward-looking statements. Actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, but are not limited to,
risks and uncertainties related to: macroeconomic conditions and
the effects of global health concerns, such as global pandemics;
Turnstone’s ability to initiate and execute clinical trials on the
anticipated timelines, if at all; the potential for results from
clinical trials to differ from preclinical, early clinical,
preliminary or expected results; the significant uncertainty
associated with Turnstone’s product candidates ever receiving any
regulatory approvals; Turnstone’s ability to obtain, maintain or
protect intellectual property rights related to its product
candidates; the sufficiency of Turnstone’s capital resources and
need for additional capital to achieve its goals; and other risks,
including those described under the heading “Risk Factors” in
Turnstone’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2023, filed with the SEC on November 13, 2023 and
other documents Turnstone has filed, or will file, with the SEC,
including the Annual Report on Form 10-K for the year ended
December 31, 2023. This press release discusses product candidates
that are under clinical study and which have not yet been approved
for marketing by the U.S. Food and Drug Administration. No
representation is made as to the safety or effectiveness of these
product candidates for the uses for which they are being
studied.
Contact:
Ahmed AneiziInvestor RelationsTurnstone
Biologics(347) 897-5988ahmed.aneizi@turnstonebio.com
|
Turnstone Biologics, Corp.Condensed
Consolidated Statement of Operations and Comprehensive Income
(Loss)(unaudited)(In thousands, except share and
per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended December 31, |
|
Twelve Months ended December 31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
Collaboration revenue |
$ |
- |
|
|
$ |
10,447 |
|
|
$ |
19,306 |
|
|
$ |
73,300 |
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
Research and development |
|
13,458 |
|
|
|
20,214 |
|
|
|
60,491 |
|
|
|
86,703 |
|
|
|
General and administrative |
|
4,398 |
|
|
|
4,353 |
|
|
|
17,847 |
|
|
|
18,223 |
|
|
|
Total operating expenses |
|
17,856 |
|
|
|
24,567 |
|
|
|
78,338 |
|
|
|
104,926 |
|
|
|
Loss from operations |
|
(17,856 |
) |
|
|
(14,120 |
) |
|
|
(59,032 |
) |
|
|
(31,626 |
) |
|
|
Other income, net |
|
1,241 |
|
|
|
468 |
|
|
|
3,546 |
|
|
|
933 |
|
|
|
Net loss before income taxes |
|
(16,615 |
) |
|
|
(13,652 |
) |
|
|
(55,486 |
) |
|
|
(30,693 |
) |
|
|
Benefit (provision) for income taxes |
|
165 |
|
|
|
(15 |
) |
|
|
286 |
|
|
|
(141 |
) |
|
|
Net loss |
$ |
(16,450 |
) |
|
$ |
(13,667 |
) |
|
$ |
(55,200 |
) |
|
$ |
(30,834 |
) |
|
|
Other comprehensive income (loss) |
|
122 |
|
|
|
72 |
|
|
|
294 |
|
|
|
(168 |
) |
|
|
Total comprehensive income (loss) |
$ |
(16,328 |
) |
|
$ |
(13,595 |
) |
|
$ |
(54,906 |
) |
|
$ |
(31,002 |
) |
|
| |
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholder, basic and diluted |
|
(16,773 |
) |
|
|
(13,688 |
) |
|
|
(55,239 |
) |
|
|
(31,024 |
) |
|
|
Weighted-average shares of common stock outstanding, basic and
diluted |
|
22,934,594 |
|
|
|
2,484,569 |
|
|
|
11,562,910 |
|
|
|
2,484,569 |
|
|
|
Net loss per share attributable to common stockholders, basic and
diluted |
$ |
(0.73 |
) |
|
$ |
(5.51 |
) |
|
$ |
(4.78 |
) |
|
$ |
(12.49 |
) |
|
| |
|
|
|
|
|
|
|
|
|
Turnstone Biologics, Corp.Condensed
Consolidated Balance Sheet (unaudited)(amount in
thousands) |
|
|
| |
December 31, 2023 |
December 31, 2022 |
|
| |
|
|
|
|
Cash and cash equivalents and short-term investments |
$ |
94,777 |
$ |
82,061 |
|
|
|
Total assets |
|
112,815 |
|
114,938 |
|
|
|
Total liabilities |
|
14,148 |
|
44,461 |
|
|
|
Total redeemable convertible preferred stock |
|
- |
|
171,944 |
|
|
|
Total stockholders' deficit |
|
98,667 |
|
(101,467 |
) |
|
| |
|
|
|
Turnstone Biologics (NASDAQ:TSBX)
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