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 fourth quarter and full year
ended December 31, 2021 and provided recent business highlights.
“We took a very important step in 2021 toward validating the
Agonist Redirected Checkpoint (ARC) platform as a new class of
biologic medicine, through sharing initial clinical data from our
SL-172154 and SL-279252 programs at the 36th annual meeting of the
Society for the Immunotherapy of Cancer. The observation of initial
anti-tumor activity and dose-dependent activation of CD40 and OX40
are differentiating features of ARCs that bode well for the next
stage of clinical development,” said Taylor Schreiber, M.D., Ph.D.,
and Chief Executive Officer of Shattuck. “With SL-172154, we are
pleased with the safety profile, evidence of target saturation, and
potent dose-dependent CD40 activation, which prompted our
combination strategy aimed to demonstrate significant anti-tumor
activity. Based on the clinical data to date and evolving
development landscape, we believe SL-172154 could emerge as both a
first-in-class and best-in-class CD47 inhibitor and CD40
agonist.”
Fourth Quarter 2021 Recent Business Highlights and Other
Recent Developments
ARC Clinical-Stage and Preclinical Pipeline
SL-172154 (SIRPα-Fc-CD40L)
- Announced
Initial Data from SL-172154 Phase 1 Dose-Escalation Clinical Trial
in Platinum-Resistant Ovarian Cancer Demonstrating Favorable Safety
Profile, High Target Occupancy, and Unique Pharmacodynamic Activity
at the 36th Annual SITC Meeting: The Phase 1 trial is an
open-label, multi-center, dose-escalation trial to evaluate the
safety, tolerability, pharmacokinetics, anti-tumor activity, and
pharmacodynamic effects of SL-172154 administered intravenously in
patients with platinum-resistant ovarian cancer. Data reported at
the 36th Annual SITC Meeting was in 15 evaluable patients, across
four dose levels on two schedules: schedule 1 (day 1, 8, 15, 29,
then every two weeks) at 0.1 and 0.3 mg/kg and schedule 2 (weekly)
at 0.3, 1.0, and 3.0 mg/kg. SL-172154 was well tolerated through
3.0 mg/kg, and no dose-limiting toxicities were observed.
Preferential binding to CD47 on leukocytes, compared to red blood
cells, was observed and exceeded 80% of CD47 expressing leukocytes
in most patients at doses of 1.0 and 3.0 mg/kg. Dose-dependent CD40
receptor occupancy was also observed, which approached 100% of CD40
expressing cells at the 3.0 mg/kg dose level and correlated with
multiple signs of CD40 activation. Specifically, dose-dependent
margination of CD40 expressing B cells and monocytes was observed
following each infusion, and large increases in multiple serum
cytokines, including IL-12, were also reported. Shattuck is
continuing dose escalation to 10.0 mg/kg.
- Combination Trial with
SL-172154 with Liposomal Doxorubicin Expected to Begin in
2022: A Phase 1B trial of SL-172154 in combination with
liposomal doxorubicin to evaluate safety, tolerability,
pharmacokinetics, anti-tumor activity, and pharmacodynamics in
patients with advanced, platinum-resistant ovarian cancer is
expected to begin enrollment in 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.
- Initiated Phase 1A/B
Clinical Trial in AML and HR-MDS with SL-172154: Shattuck
is conducting a Phase 1A/B clinical trial evaluating the safety,
tolerability, pharmacokinetics, anti-tumor activity, and
pharmacodynamic effects of SL-172154, as both monotherapy and in
combination. In acute myeloid leukemia (AML), Shattuck plans to
evaluate SL-172154 in combination with both azacitidine and
venetoclax. In both HR-MDS and TP53 mutant AML, Shattuck plans to
evaluate SL-172154 in combination with azacitidine. Initial data
from the trial are expected in the first half of 2023.
- Closed Enrollment of Intratumorally Administered
SL-172154 Phase 1 Clinical Trial in Squamous Cell Carcinoma of the
Head and Neck or Skin to Focus on Intravenous Administration
Strategy: Based on the totality of the safety and
biomarker data collected to date in our ongoing Phase 1A clinical
trial in ovarian cancer patients, we have decided to focus
development of SL-172154 as an intravenously administered product
candidate. As of February 24, 2022, Shattuck has closed enrollment
of the Phase 1 clinical trial for SL-172154 in patients with
squamous cell carcinoma of the head and neck (HNSCC) or skin (CSCC)
to further focus all development of SL-172154 as an intravenously
administered product candidate. Shattuck did not observe
dose-limiting toxicities and did not reach a maximum tolerated dose
in this trial. Data from the trial are expected in the first half
of 2022. Shattuck may continue further development of HNSCC and/or
CSCC in an intravenous administration trial of SL-172154 following
selection of a recommended Phase 2 dose in Shattuck’s ovarian
cancer trial.
SL-279252 (PD1-Fc-OX40L)
- Announced Initial Data from
Ongoing SL-279252 Phase 1 Dose-Escalation Clinical Trial in
Advanced Solid Tumors Demonstrating Evidence of Anti-Tumor Activity
and Dose-Dependent Pharmacodynamic Activity at the 36th Annual SITC
Meeting: The Phase 1 trial is an open-label, multi-center,
dose-escalation study to evaluate the safety, tolerability,
pharmacokinetics, anti-tumor activity and pharmacodynamic effects
of SL-279252 in patients with advanced solid tumors and lymphoma.
SL-279252 was well tolerated across a dose-range of 0.0001 mg/kg
through 6.0 mg/kg, and dose-dependent margination of CD4+OX40+ T
cells was the primary pharmacodynamic effect observed and had not
plateaued through the 6.0 mg/kg dose level. Monotherapy anti-tumor
activity was observed at doses of 1.0 mg/kg and higher, including a
confirmed partial response in a PD-1 and CTLA-4 inhibitor
experienced ocular melanoma patient who remained on therapy for
over 12 months. Shattuck continues to dose patients, primarily
selecting for patients with PD-L1 expressing tumors, at 12.0 mg/kg
and plans to continue dose escalation to 24.0 mg/kg, to fully
characterize pharmacokinetic, pharmacodynamic, and anti-tumor
activity. Additional dose-escalation data from the trial are
expected in the second half of 2022.
Preclinical
- Presented Continued
Preclinical Development of SL-9258 at the
TIGIT Therapies Digital Summit in December
2021: Preclinical data for SL-9258
(TIGIT-Fc-LIGHT), a dual TIGIT inhibitor and HVEM/LTβR agonist,
were presented at the TIGIT Therapies Summit in December 2021.
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.
Upcoming Events
- American Association for Cancer
Research Annual Meeting (AACR), April 8-13
- Poster presentation on the preclinical
development of SL-9258
- Poster presentation on the preclinical
development of GADLEN compounds
- Shattuck plans to attend the following
investor conferences. Details of the presentations and webcasts
will be announced prior to the events.
- 21st Annual Needham Healthcare
Conference, April 11-14
- 8th Annual Berenberg Conference USA
2022, May 23-25
Fourth Quarter 2021 Financial Results
- Cash Position: As of
December 31, 2021, cash, cash equivalents and short-term
investments were $268.8 million, as compared to $335.4 million as
of December 31, 2020.
- Collaboration Revenue:
Revenue for the fourth quarter of 2021, was $30.1 million, as
compared to $1.3 million for the fourth quarter of 2020. Revenue
for the year ended December 31, 2021 was $30.0 million, as compared
to $9.9 million for the year ended December 31, 2020. The increase
in revenue was due to the recognition of all remaining deferred
revenue related to the Collaboration Agreement with Takeda
Pharmaceuticals in the fourth quarter of 2021.
- Research and Development
(R&D) Expenses: R&D expenses were $16.2 million
for the fourth quarter of 2021, as compared to $9.8 million for the
fourth quarter of 2020. R&D expenses for the year ended
December 31, 2021 were $56.6 million, as compared to $37.5 million
for the year ended December 31, 2020. This increase was primarily
due to clinical development, personnel-related costs, and
laboratory capabilities.
- General and Administrative
(G&A) Expenses: G&A expenses were $4.6 million for
the fourth quarter of 2021, as compared to $3.6 million for the
fourth quarter of 2020. General and administrative expenses for the
year ended December 31, 2021 were $18.7 million, as compared to
$9.4 million for the year ended December 31, 2020. This increase
was primarily due to personnel-related costs to support the
operational expansion and costs associated with being a public
company.
- Net Income/Loss: Net
income was $7.8 million for the fourth quarter of 2021, or $0.19
per basic share and $0.18 per diluted share, as compared to a net
loss of $12.0 million for the fourth quarter of 2020, or $0.31 per
basic and diluted share. Net loss for the year ended December 31,
2021 was $45.0 million, or $1.07 per basic and diluted share, as
compared to $36.6 million, or $2.36 per basic and diluted share,
for the year ended December 31, 2020.
2022 Financial Guidance
Shattuck believes its cash, cash equivalents and short-term
investments will be sufficient to fund its operations into the
second half of 2024, which is 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-172154SL-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, with
multiple ongoing Phase 1 clinical trials. 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 StatementsCertain 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 of enrollment of those trials, the
anticipated timing of the results from those studies and trials,
anticipated timing for preclinical development updates, the
potential for additional studies based on current trials and
studies, the efficacy and safety of our product candidates, the
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 ongoing 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, to be 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 Contact: Conor RichardsonSenior
Director, Finance & Investor RelationsShattuck Labs,
Inc.InvestorRelations@shattucklabs.com
Media Contact:Stephanie Ascher Managing
DirectorStern Investor Relations,
Inc.Stephanie.ascher@sternir.com
FINANCIAL INFORMATION
SHATTUCK LABS, INC.
BALANCE SHEETS
(In thousands)
|
December 31, |
|
|
2021 |
|
|
|
2020 |
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
92,268 |
|
|
$ |
157,898 |
|
Short-term investments |
|
176,536 |
|
|
|
177,551 |
|
Prepaid expenses and other current assets |
|
19,462 |
|
|
|
10,190 |
|
Total current assets |
|
288,266 |
|
|
|
345,639 |
|
Property and equipment,
net |
|
9,938 |
|
|
|
3,000 |
|
Other assets |
|
381 |
|
|
|
349 |
|
Total assets |
$ |
298,585 |
|
|
$ |
348,988 |
|
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
10,012 |
|
|
$ |
1,754 |
|
Accrued expenses |
|
14,574 |
|
|
|
7,352 |
|
Deferred revenue - related party |
|
— |
|
|
|
7,728 |
|
Total current liabilities |
|
24,586 |
|
|
|
16,834 |
|
Deferred rent |
|
2,213 |
|
|
|
987 |
|
Deferred revenue - related
party, net of current portion |
|
— |
|
|
|
21,306 |
|
Total liabilities |
|
26,799 |
|
|
|
39,127 |
|
Stockholders’ equity: |
|
|
|
Common stock |
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
389,408 |
|
|
|
382,012 |
|
Accumulated other comprehensive loss |
|
(560 |
) |
|
|
(63 |
) |
Accumulated deficit |
|
(117,067 |
) |
|
|
(72,093 |
) |
Total stockholders’ equity |
|
271,786 |
|
|
|
309,861 |
|
Total liabilities and stockholders’ equity |
$ |
298,585 |
|
|
$ |
348,988 |
|
SHATTUCK LABS,
INC.STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS(In thousands, except share and per share
amounts)
|
Three Months Ended December 31,
(Unaudited) |
|
Year Ended December 31, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Collaboration revenue -
related party |
$ |
30,078 |
|
|
$ |
1,342 |
|
|
$ |
30,017 |
|
|
$ |
9,934 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
16,207 |
|
|
|
9,786 |
|
|
|
56,563 |
|
|
|
37,483 |
|
General and administrative |
|
4,624 |
|
|
|
3,567 |
|
|
|
18,723 |
|
|
|
9,382 |
|
Expense from operations |
|
20,831 |
|
|
|
13,353 |
|
|
|
75,286 |
|
|
|
46,865 |
|
Gain (loss) from
operations |
|
9,247 |
|
|
|
(12,011 |
) |
|
|
(45,269 |
) |
|
|
(36,931 |
) |
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
Interest income (expense) |
|
(1,321 |
) |
|
|
75 |
|
|
|
625 |
|
|
|
549 |
|
Other |
|
(79 |
) |
|
|
(77 |
) |
|
|
(330 |
) |
|
|
(221 |
) |
Total other income (expense) |
|
(1,400 |
) |
|
|
(2 |
) |
|
|
295 |
|
|
|
328 |
|
Net income (loss) |
$ |
7,847 |
|
|
$ |
(12,013 |
) |
|
$ |
(44,974 |
) |
|
$ |
(36,603 |
) |
Unrealized gain (loss) on investments |
|
1,267 |
|
|
|
(52 |
) |
|
|
(497 |
) |
|
|
(117 |
) |
Comprehensive gain (loss) |
$ |
9,114 |
|
|
$ |
(12,065 |
) |
|
$ |
(45,471 |
) |
|
$ |
(36,720 |
) |
|
|
|
|
|
|
|
|
Basic and Diluted Per Common
Share Data: |
|
|
|
|
|
|
|
Net earnings (loss) per share
- basic |
$ |
0.19 |
|
|
$ |
(0.31 |
) |
|
$ |
(1.07 |
) |
|
$ |
(2.36 |
) |
Weighted-average shares
outstanding - basic |
|
42,286,190 |
|
|
|
38,800,057 |
|
|
|
42,032,384 |
|
|
|
15,506,067 |
|
Net earnings (loss) per share
- diluted |
$ |
0.18 |
|
|
$ |
(0.31 |
) |
|
$ |
(1.07 |
) |
|
$ |
(2.36 |
) |
Weighted-average shares
outstanding - diluted |
|
44,734,866 |
|
|
|
38,800,057 |
|
|
|
42,032,384 |
|
|
|
15,506,067 |
|
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