Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage
biotechnology company pioneering the development of bi-functional
fusion proteins as a new class of biologic medicine for the
treatment of patients with cancer and autoimmune disease, today
reported financial results for the quarter ended March 31, 2022 and
provided recent business highlights.
“We are now completing the monotherapy dose-escalation study for
SL-172154 in ovarian cancer patients and are focused on the
initiation and rapid clinical execution of multiple combination
studies in both hematologic and solid tumors. This expansion is a
critical step in establishing SL-172154 as both a first- and
best-in-class CD47 inhibitor and CD40 agonist, and we continue to
expect SL-172154 to differentiate from other CD47 inhibitors and
CD40 agonists in terms of safety, pharmacodynamic activity, and
efficacy in combinations. The next 18 months are shaping up to be a
defining period for establishing CD47 inhibition as a key
macrophage checkpoint in multiple indications, and we look forward
to providing initial combination data from SL-172154 in the first
half of 2023,” said Taylor Schreiber, M.D., Ph.D., and Chief
Executive Officer of Shattuck.
First Quarter 2022 Recent Business Highlights and Other
Recent Developments
ARC Clinical-Stage Pipeline and Preclinical
Pipeline
SL-172154 (SIRPα-Fc-CD40L)
- Continued Enrollment of
SL-172154 Phase 1A Dose-Escalation Clinical Trial in
Platinum-Resistant Ovarian Cancer: This open-label,
multi-center, dose-escalation clinical trial is evaluating the
safety, tolerability, pharmacokinetics, anti-tumor activity, and
pharmacodynamic effects of SL-172154 administered intravenously in
patients with platinum resistant ovarian cancer. Full
dose-escalation data from the trial are expected in the first half
of 2023.
- Phase 1B Clinical Trial of
SL-172154 in Combination with Liposomal Doxorubicin Expected to
Begin in the Second Half of 2022: This clinical trial will
evaluate the safety, tolerability, pharmacokinetics, anti-tumor
activity, and pharmacodynamics effects of SL-172154 in combination
with liposomal doxorubicin in patients with advanced,
platinum-resistant ovarian cancer and is anticipated to begin
enrollment in the second half of 2022. Initial combination data
from the trial are expected in the first half of 2023. Additional
combination trials with SL-172154 in ovarian cancer and novel
agents are currently being planned.
- Enrollment Continues in
SL-172154 Phase 1A/B Clinical Trial in Acute Myeloid Leukemia (AML)
and Higher-Risk Myelodysplastic Syndromes (HR-MDS): The
trial is evaluating the safety, tolerability, pharmacokinetics,
anti-tumor activity, and pharmacodynamic effects of SL-172154, as
both monotherapy and in combination. In both HR-MDS and TP53 mutant
AML, SL-172154 will be combined with azacitidine. In AML, SL-172154
will be evaluated in combination with both azacitidine and
venetoclax. Initial data from the monotherapy and combination dose
escalation portions of the trial are expected in the first half of
2023.
- Data for Intratumorally
Administered SL-172154 Phase 1 Clinical Trial in Squamous Cell
Carcinoma of the Head and Neck or Skin to be Presented in the
Second Half of 2022: Shattuck anticipates presenting data
from the clinical trial in the second half of 2022. Shattuck may
continue further development of SL-172154 in squamous cell
carcinoma of the head and neck (HNSCC) or skin (CSCC) via
intravenous administration following selection of a recommended
Phase 2 dose in ovarian cancer.
SL-279252 (PD1-Fc-OX40L)
- Continued Enrollment of
SL-279252 Phase 1 Dose-Escalation Clinical Trial in Advanced Solid
Tumors: Enrollment of patients with primarily PD-L1
selected tumors continues in the Phase 1 open-label, multi-center,
dose-escalation clinical trial to evaluate the safety,
tolerability, pharmacokinetics, anti-tumor activity and
pharmacodynamic effects of SL-279252 in patients with advanced
solid tumors and lymphoma. Top-line data from all treated subjects
across the full dose range are anticipated in the second half of
2022.
Preclinical
- Presented
Preclinical Data on SL-9258 at AACR in
April: Preclinical data for SL-9258
(TIGIT-Fc-LIGHT), a dual TIGIT inhibitor and HVEM/LTβR agonist,
were presented at the American Association for Cancer Research
Annual Meeting (AACR) in April 2022. These data, from studies in a
mouse model, provided preclinical evidence for anti-tumor activity
of the murine equivalent of SL-9258 in PD-1 acquired resistant
tumors and increased tumor rejection in comparison to TIGIT
blocking antibodies. In these preclinical models, TIGIT-Fc-LIGHT
outperformed TIGIT blocking antibodies independent of PD-L1 or
DNAM-1 (CD226) expression. TIGIT-Fc-LIGHT was also evaluated and
well tolerated in non-human primates and observed similar on-target
pharmacodynamic activity to what was characterized in the mouse
model. Together, these results suggest that TIGIT-Fc-LIGHT may
provide clinical benefit to patients that are refractory to
conventional checkpoint blockade therapy.
- Presented Preclinical Data at
AACR on GADLEN Platform: Shattuck also presented
preclinical data highlighting the potential of GADLENs to direct
gamma delta T cells to kill tumor cells and, in the process,
further elucidate tumor cell markers which are important for the
therapeutic activity of gamma delta T cell-based therapies.
Butyrophilin heterodimeric fusion proteins from Shattuck’s GADLEN
platform showed enhanced tumor cell killing targeting CD19 and CD20
and demonstrated preclinical proof of concept in the treatment of
cancer.
- Clinical Pipeline Product
Candidate to be Selected in 2022: As Shattuck looks to
advance its preclinical pipeline, a new product candidate from the
ARC or GADLEN platform is anticipated to be selected in the second
half of 2022.
Upcoming Events
H.C. Wainwright 2022 Global Investment
Conference
Management will participate in investor one-on-one meetings and
give a corporate presentation during the H.C. Wainwright 2022
Global Investment Conference from May 24-26, 2022. A live and
archived audio webcast of the presentation will be available by
visiting the Events & Presentations section of the Company’s
website.
First Quarter 2022 Financial Results
- Cash Position: As of
March 31, 2022, cash and cash equivalents and short-term
investments were $239.2 million, as compared to $321.2 million as
of March 31, 2021.
- Research and Development
(R&D) Expenses: R&D expenses were $19.2 million
for the quarter ended March 31, 2022, as compared to $10.3 million
for the quarter ended March 31, 2021. This increase was primarily
driven by increases in process development costs and manufacturing
of trial materials and personnel-related costs.
- General and Administrative
(G&A) Expenses: G&A expenses were $5.0 million for
the quarter ended March 31, 2022, as compared to $4.4 million for
the quarter ended March 31, 2021. This increase was primarily
driven by increases in compensation related and other operating
costs.
- Net Income/Loss: Net
loss was $24.5 million for the quarter ended March 31, 2022, or
$0.58 per basic and diluted share, as compared to a net loss of
$11.8 million for the quarter ended March 31, 2021, or $0.28 per
basic and diluted share.
2022 Financial Guidance
Shattuck believes its cash and cash equivalents and short-term
investments will be sufficient to fund its operations into the
second half of 2024, beyond results from its Phase 1 clinical
trials of SL-172154 and SL-279252. This cash runway guidance is
based on the Company’s current operational plans and excludes any
additional funding that may be received or business development or
additional clinical development activities that may be
undertaken.
About SL-172154
SL-172154 (SIRPα-Fc-CD40L) is an investigational ARC® fusion
protein designed to simultaneously inhibit the CD47/SIRPα
checkpoint interaction and activate the CD40 costimulatory receptor
to bolster an anti-tumor immune response in patients with advanced
cancer. Two Phase 1 clinical trials are ongoing, the first for
patients with advanced and platinum resistant ovarian cancer
(NCT04406623) and the second for patients with AML and HR-MDS
(NCT05275439).
About SL-279252
SL-279252 (PD1-Fc-OX40L) is an investigational ARC® fusion
protein designed to simultaneously inhibit the PD-1/PD-L1
interaction and activate the OX40 receptor in patients with
advanced cancers. A Phase 1 trial in patients with solid tumors and
lymphoma is ongoing (NCT03894618).
About Shattuck Labs, Inc.
Shattuck Labs, Inc. (NASDAQ: STTK) is a clinical-stage
biotechnology company pioneering the development of bi-functional
fusion proteins as a new class of biologic medicine for the
treatment of patients with cancer and autoimmune disease. Compounds
derived from Shattuck’s proprietary Agonist Redirected Checkpoint,
ARC®, platform simultaneously inhibit checkpoint molecules and
activate costimulatory molecules within a single therapeutic. The
company’s SL-172154 (SIRPα-Fc-CD40L) program, which is designed to
block the CD47 immune checkpoint and simultaneously agonize the
CD40 pathway, is being evaluated in two Phase 1 trials. A second
product candidate, SL-279252 (PD1-Fc-OX40L), is being evaluated in
a Phase 1 trial in solid tumors or lymphomas. Additionally, the
company is advancing a proprietary Gamma Delta T Cell Engager,
GADLEN™, platform, which is designed to bridge gamma delta T cells
to tumor antigens for the treatment of patients with cancer.
Shattuck has offices in both Austin, Texas and Durham, North
Carolina. For more information, please visit:
www.ShattuckLabs.com.
Forward-Looking Statements
Certain statements in this press release may constitute
“forward-looking statements” within the meaning of the federal
securities laws, including, but not limited to, our expectations
regarding plans for our preclinical studies, clinical trials and
research and development programs, the anticipated timing for
enrollment of our clinical trials, the anticipated timing of the
results from our preclinical studies and clinical trials,
anticipated timing for preclinical development updates, potential
clinical benefit of our product candidates, and expectations
regarding the time period over which our capital resources will be
sufficient to fund our anticipated operations. Words such as “may,”
“might,” “will,” “objective,” “intend,” “should,” “could,” “can,”
“would,” “expect,” “believe,” “design,” “estimate,” “predict,”
“potential,” “develop,” “plan” or the negative of these terms, and
similar expressions, or statements regarding intent, belief, or
current expectations, are forward-looking statements. While we
believe these forward-looking statements are reasonable, undue
reliance should not be placed on any such forward-looking
statements, which are based on information available to us on the
date of this release. These forward-looking statements are based
upon current estimates and assumptions and are subject to various
risks and uncertainties (including, without limitation, those set
forth in our filings with the U.S. Securities and Exchange
Commission (the “SEC”)), many of which are beyond our control and
subject to change. Actual results could be materially different.
Risks and uncertainties include: the recent and ongoing COVID-19
pandemic; expectations regarding the initiation, progress, and
expected results of our preclinical studies, clinical trials and
research and development programs; expectations regarding the
timing, completion and outcome of our clinical trials; the
unpredictable relationship between preclinical study results and
clinical study results; the timing or likelihood of regulatory
filings and approvals; liquidity and capital resources; and other
risks and uncertainties identified in our Annual Report on Form
10-K for the year ended December 31, 2021, filed on March 15, 2022
with the SEC. We claim the protection of the Safe Harbor contained
in the Private Securities Litigation Reform Act of 1995 for
forward-looking statements. We expressly disclaim any obligation to
update or alter any statements whether as a result of new
information, future events or otherwise, except as required by
law.
The Company intends to use the investor relations portion of its
website as a means of disclosing material non-public information
and for complying with disclosure obligations under Regulation
FD.
Investor & Media Contact: Conor
RichardsonSenior Director, Finance & Investor RelationsShattuck
Labs, Inc.InvestorRelations@shattucklabs.com
PART I - FINANCIAL
INFORMATION
Item 1. Financial Statements
SHATTUCK LABS, INC.
BALANCE SHEETS
(In thousands)
|
March 31, 2022 |
December 31,2021 |
|
(unaudited) |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
50,743 |
|
$ |
92,268 |
|
Investments |
|
188,482 |
|
|
176,536 |
|
Prepaid expenses and other current assets |
|
15,763 |
|
|
19,462 |
|
Total current assets |
|
254,988 |
|
|
288,266 |
|
Property and equipment,
net |
|
12,274 |
|
|
9,938 |
|
Other assets |
|
3,228 |
|
|
381 |
|
Total assets |
$ |
270,490 |
|
$ |
298,585 |
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$ |
2,593 |
|
$ |
10,012 |
|
Accrued expenses and other current liabilities |
|
14,221 |
|
|
14,574 |
|
Total current liabilities |
|
16,814 |
|
|
24,586 |
|
Non-current operating lease
liabilities |
|
4,738 |
|
|
Deferred rent |
|
— |
|
|
2,213 |
|
Total liabilities |
|
21,552 |
|
|
26,799 |
|
Stockholders’ equity: |
|
|
Common stock |
|
5 |
|
|
5 |
|
Additional paid-in capital |
|
391,055 |
|
|
389,408 |
|
Accumulated other comprehensive loss |
|
(527 |
) |
|
(560 |
) |
Accumulated deficit |
|
(141,595 |
) |
|
(117,067 |
) |
Total stockholders’ equity |
|
248,938 |
|
|
271,786 |
|
Total liabilities and stockholders’ equity |
$ |
270,490 |
|
$ |
298,585 |
|
SHATTUCK LABS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except share and per share
amounts)
|
Three Months Ended March 31, |
|
|
2022 |
|
|
|
2021 |
|
Collaboration revenue -
related party |
$ |
— |
|
|
$ |
2,270 |
|
Operating expenses: |
|
|
|
Research and development |
|
19,187 |
|
|
|
10,337 |
|
General and administrative |
|
4,979 |
|
|
|
4,356 |
|
Expense from operations |
|
24,166 |
|
|
|
14,693 |
|
Loss from operations |
|
(24,166 |
) |
|
|
(12,423 |
) |
|
|
|
|
Other income (expense): |
|
|
|
Other |
|
(362 |
) |
|
|
610 |
|
Net loss |
$ |
(24,528 |
) |
|
$ |
(11,813 |
) |
Unrealized gain (loss) on
investments |
|
33 |
|
|
|
(597 |
) |
Comprehensive loss |
$ |
(24,495 |
) |
|
$ |
(12,410 |
) |
|
|
|
|
Net loss per share – basic and
diluted |
$ |
(0.58 |
) |
|
$ |
(0.28 |
) |
Weighted-average shares
outstanding – basic and diluted |
|
42,357,625 |
|
|
|
41,774,111 |
|
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