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 with three
ongoing Phase 1 clinical trials, today reported financial results
for the third quarter ended September 30, 2021, and provided recent
business highlights.
“We designed the ARC platform to simultaneously block immune
checkpoint targets and activate immune costimulatory receptors in
the TNF superfamily. The clinical data presented this week at SITC
demonstrate evidence of anti-tumor activity, target receptor
binding, and dose-dependent immune activation specific to each of
CD40 and OX40,” said Taylor Schreiber, M.D., Ph.D., and Chief
Executive Officer of Shattuck. “Both compounds have been well
tolerated and are demonstrating predictable dose-response
relationships in humans. The doses we have explored to date remain
below the recommended Phase 2 doses of benchmark CD47 inhibitors
and PD-L1 inhibitors, and we look forward to continuing dose
escalation of both SL-172154 and SL-279252 into dose levels that we
believe will maximize the pharmacodynamic activity and anti-tumor
activity of each compound.”
“We are very encouraged by the initial data from the Phase 1
trial of SL-172154. The data show an excellent safety profile, high
CD47 receptor occupancy and clear evidence of CD40 engagement,
which collectively differentiate SL-172154 from other CD47
inhibitors,” said Nehal Lakhani, M.D., Ph.D., South Texas
Accelerated Research Therapeutics (START) Midwest, Grand Rapids,
MI. “We desperately need new therapies for late-stage ovarian
cancer patients, particularly in the platinum resistant setting.
The combined actions of CD47 inhibition and CD40 activation
provided by SL-172154 represents a strategy that has not yet been
examined in this disease and may initiate anti-tumor immune
responses that could provide lasting benefits in late-stage ovarian
cancer.”
“SL-172154 is emerging as a highly differentiated CD47
inhibitor. The clinical data indicate that this compound can safely
engage CD40 in a manner that has evaded other CD40-targeted
biologics for over twenty years. At the same time, we can compare
and contrast the relative potency of CD40 versus OX40 activation,
and the clinical data indicate that CD40 targeting provides
substantially more immunologic activity than OX40 activation. There
are some parallels to these observations in the checkpoint space,
where blockade of targets like LAG3, TIM3, and TIGIT has been far
more subtle than blockade of CTLA-4 or PD-1,” continued Dr.
Schreiber. “The current data suggests that we may be coming close
to a recommended Phase 2 dose selection for SL-172154 as
monotherapy. We are excited to transition to the combination with
liposomal doxorubicin in ovarian cancer, and with azacitidine and
venetoclax in AML, and azacitidine in higher-risk MDS and TP53
mutant AML. More importantly, these data help to establish the ARC
platform more broadly as a novel class of biologic medicine, which
opens opportunities for the rest of our vast pipeline of candidates
developed internally at Shattuck.”
Third Quarter 2021 Recent Business Highlights and Other
Recent Developments
Agonist Redirected Checkpoint (ARC) Platform
Clinical-Stage Pipeline
- Initial Data from Ongoing
SL-172154 (SIRPα-Fc-CD40L) Phase 1 Dose-Escalation Clinical Trial
in Platinum Resistant Ovarian Cancer Demonstrate Favorable Safety
Profile and High Target Occupancy 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-172154 administered intravenously in
patients with platinum resistant ovarian cancer. Shattuck will
continue dose escalation to 10mg/kg.
- Data reported at SITC was in 14
evaluable patients as of July 6, 2021, across four dose levels on
two schedules: schedule 1 (day 1, 8, 15, 29, then every two weeks)
at 0.1, 0.3 mg/kg and schedule 2 (weekly) at 0.3, 1.0, 3.0 mg/kg.
To date, no dose limiting toxicities have been observed.
- Preliminary pharmacodynamic
parameters for SL-172154 demonstrate on-target, CD40-mediated
immune activation. The binding of SL-172154 to CD40+ B cells and
monocytes led to rapid activation and margination of these cells
post infusion.
- High target occupancy was observed
on CD47+ leukocytes at the doses studied, with preferential binding
to leukocytes as compared to red blood cells.
- Cyclical increases in certain innate
and adaptive serum cytokines were consistent with CD40 receptor
engagement and activation following dosing. There were no notable
increases in IL-6 or TNFα, or evidence of bell-shaped dose
responses.
- SL-172154 has been well tolerated at
doses which achieve near-complete target occupancy for both CD40
and CD47, with evidence of on-target pharmacodynamic activity which
has not yet plateaued, warranting further dose escalation.
- Combination Study of
SL-172154 with Liposomal Doxorubicin Expected to Begin First Half
of 2022: A Phase 1B clinical trial of SL-172154 in
combination with liposomal doxorubicin to evaluate safety,
tolerability, pharmacokinetics, anti-tumor activity, and
pharmacodynamics is planned to begin enrolling in the first half of
2022. Shattuck continues to evaluate additional combination agents
for SL-172154 for the treatment of patients with ovarian
cancer.
- Open IND for SL-172154 in
AML and HR-MDS: Shattuck submitted an investigational
new drug application to the U.S. Food and Drug
Administration for a Phase 1A/B clinical trial for SL-172154
in patients with acute myeloid leukemia, or AML and, higher-risk
myelodysplastic syndromes, or HR-MDS, in September. The IND is now
open, and the trial will evaluate safety, tolerability,
pharmacokinetics, anti-tumor activity, and pharmacodynamic effects
of SL-172154, as both monotherapy and in combination. In 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 second
half of 2022.
- Continued Enrollment of
SL-172154 Phase 1 Clinical Trial in Squamous Cell Carcinoma of the
Head and Neck or Skin: Shattuck continues to enroll
patients in a Phase 1 clinical trial for SL-172154, in patients
with squamous cell carcinoma of the head and neck or skin. The
Phase 1 trial is evaluating the safety, tolerability,
pharmacokinetics, anti-tumor activity, and pharmacodynamic effects
of SL-172154, administered intratumorally as monotherapy. Initial
dose-escalation data from the trial are expected in the first half
of 2022.
- Initial Data from Ongoing
SL-279252 (PD1-Fc-OX40L) Phase 1 Dose-Escalation Clinical Trial in
Advanced Solid Tumors Demonstrate Evidence of Anti-Tumor
Activity at the 36th Annual SITC
Meeting: The ongoing Phase 1 trial is an
open-label, multi-center, dose-escalation, and dose-expansion study
to evaluate the safety, tolerability, pharmacokinetics, anti-tumor
activity, and pharmacodynamic effects of SL-279252 as monotherapy
in patients with advanced solid tumors. Today, Shattuck reported
continued enrollment at the next dose level, 12 mg/kg.
- Data reported at SITC as of June 11,
2021, was in 43 patients, dosed intravenously, with 30 patients
treated on schedule 1 (day 1, 8, 15, 29, then every 2 weeks) from
dose level 0.0001-6 mg/kg, and 13 patients treated on schedule 2
(weekly) from dose level 0.3-3 mg/kg. SL-279252 was well-tolerated
in heavily pretreated subjects with refractory solid tumors with no
maximum tolerated dose reached. A total of 16 patients were
treated at doses of 1 mg/kg or higher on schedule 1.
- Best response was one confirmed
partial response (iPR) (ocular melanoma, four prior systemic
regimens, including PD-1 and CTLA-4 inhibitors) in a patient who
remained on treatment for more than one year, and stable disease
(iSD) in 12 patients (including 1 unconfirmed iPR). iSD for > 24
weeks occurred in 5/12 patients.
- 58% of patients had received PD-1/L1
therapy, and of available tumor biopsies most tumors lacked PD-L1
expression as measured by TPS.
- SL-279252 exhibited high OX40 target
engagement and OX40-dependent PD effects.
- Shattuck is currently enrolling
patients with known PD-L1 positive tumors at dose levels of 12
mg/kg, to fully characterize PK, PD, and anti-tumor activity.
Corporate Updates
- Shattuck and Takeda Mutually
Agree to Termination of Collaboration
Agreement: In November 2021, Shattuck and
Takeda mutually agreed to termination of the Collaboration
Agreement for SL-279252 and SL-115154, originally executed in 2017.
Shattuck is no longer required to satisfy any remaining performance
obligations, the Company will not make any payments to or receive
any future milestone or royalty payments from Takeda, and all
options to license and rights of first negotiation held by Takeda
under the Collaboration Agreement were terminated.
- Changes to Shattuck’s
Board: In October 2021, Shattuck announced
changes to its board of directors.
- Dr. Carrie Brownstein was
appointed to the board and serves as a member of the Nominating and
Corporate Governance Committee. Dr. Brownstein brings over 15
years of clinical research and development experience having held
clinical leadership roles at Roche, Regeneron, Celgene and
Cellectis and as a practicing pediatric hematologist
oncologist.
- Dr. George Golumbeski was appointed
chairman of the Board. Dr. Golumbeski has served on Shattuck’s
Board as an independent director since 2018. Dr. Golumbeski
replaces Josiah Hornblower as chairman of the board. Mr. Hornblower
resigned from the board in October 2021.
Third Quarter 2021 Financial Results
- Cash Position: As of September 30, 2021, cash
and cash equivalents and short-term investments were $290.2
million, as compared to $335.4 million as of December 31,
2020.
- Research and Development (R&D) Expenses:
R&D expenses for the third quarter ended September 30,
2021, were $15.1 million, as compared to $11.8
million for the third quarter ended September 30, 2020.
The increase was primarily driven by increases in clinical
development, personnel-related costs, and laboratory
capabilities.
- General and Administrative (G&A) Expenses:
G&A expenses for the third quarter ended September 30,
2021, were $4.3 million, as compared to $2.5
million for the third quarter ended September 30, 2020.
The increase was primarily driven by an increase in personnel
related costs to support the operational expansion and costs
associated with being a public company.
- Net Loss: Net loss was $17.4 million for the
third quarter ended September 30, 2021, or $0.41 per basic and
diluted share, as compared to a net loss of $11.8 million for
the third quarter ended September 30, 2020, or $1.54 per basic
and diluted share.
2021 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, which is beyond results from its Phase 1
clinical trials of SL-172154 and SL-279252. The reduction in cash
runway guidance from our last issued guidance is primarily
attributable to increased clinical activities for SL-172154 and
ongoing process development and manufacturing to support our
ongoing and future clinical trials, including the development of a
manufacturing process suitable for registrational trials. 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
cancers. 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 advanced squamous
cell carcinoma of the head, neck or skin (NCT04502888).
About SL-279252
SL-279252 (PD1-Fc-OX40L) is an investigational ARC® fusion
protein designed to simultaneously inhibit the PD-1/PD-L1
checkpoint interaction and activate the OX40 costimulatory receptor
to bolster an anti-tumor immune response receptor in patients with
advanced solid tumors. 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
three 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 Statements
Certain statements in this press release may constitute
“forward-looking statements” within the meaning of the federal
securities laws. 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 the Company’s Annual Report on Form
10-K for the year ended December 31, 2020, filed with the U.S.
Securities and Exchange Commission (“SEC”) and other subsequent
documents we file with the SEC, many of which are beyond our
control and subject to change. Actual results could be materially
different. 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
PART I - FINANCIAL
INFORMATION
Item 1. Financial Statements
SHATTUCK LABS, INC.
BALANCE SHEETS
(In thousands)
|
September 30,2021 |
December
31,2020 |
|
(unaudited) |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
85,094 |
|
$ |
157,898 |
|
Short-term investments |
205,121 |
|
177,551 |
|
Prepaid expenses and other current assets |
11,429 |
|
10,190 |
|
Total current assets |
301,644 |
|
345,639 |
|
Property and equipment,
net |
8,651 |
|
3,000 |
|
Other assets |
273 |
|
349 |
|
Total assets |
$ |
310,568 |
|
$ |
348,988 |
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$ |
3,251 |
|
$ |
1,754 |
|
Accrued expenses |
13,783 |
|
7,352 |
|
Deferred revenue |
2,801 |
|
7,728 |
|
Total current liabilities |
19,835 |
|
16,834 |
|
Deferred revenue, net of
current portion |
27,277 |
|
21,306 |
|
Deferred rent |
2,290 |
|
987 |
|
Total liabilities |
49,402 |
|
39,127 |
|
Stockholders’ equity: |
|
|
Common stock |
5 |
|
5 |
|
Additional paid-in capital |
387,902 |
|
382,012 |
|
Accumulated other comprehensive loss |
(1,827 |
) |
(63 |
) |
Accumulated deficit |
(124,914 |
) |
(72,093 |
) |
Total stockholders’ equity |
261,166 |
|
309,861 |
|
Total liabilities and stockholders’ equity |
$ |
310,568 |
|
$ |
348,988 |
|
SHATTUCK LABS, INC.
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except share and per share
amounts)
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Collaboration revenue -
related party |
$ |
1,900 |
|
|
$ |
2,435 |
|
|
$ |
(61 |
) |
|
$ |
8,592 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
15,137 |
|
|
11,804 |
|
|
40,356 |
|
|
27,696 |
|
General and administrative |
4,343 |
|
|
2,470 |
|
|
14,098 |
|
|
5,816 |
|
Expense from operations |
19,480 |
|
|
14,274 |
|
|
54,454 |
|
|
33,512 |
|
Loss from operations |
(17,580 |
) |
|
(11,839 |
) |
|
(54,515 |
) |
|
(24,920 |
) |
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
251 |
|
|
86 |
|
|
1,947 |
|
|
474 |
|
Other |
(81 |
) |
|
(76 |
) |
|
(253 |
) |
|
(145 |
) |
Total other income |
170 |
|
|
10 |
|
|
1,694 |
|
|
329 |
|
Net loss |
$ |
(17,410 |
) |
|
$ |
(11,829 |
) |
|
$ |
(52,821 |
) |
|
$ |
(24,591 |
) |
Unrealized loss on short-term
investments |
(207 |
) |
|
(28 |
) |
|
(1,764 |
) |
|
(64 |
) |
Comprehensive loss |
$ |
(17,617 |
) |
|
$ |
(11,857 |
) |
|
$ |
(54,585 |
) |
|
$ |
(24,655 |
) |
|
|
|
|
|
|
|
|
Net loss per share – basic and
diluted |
$ |
(0.41 |
) |
|
$ |
(1.54 |
) |
|
$ |
(1.26 |
) |
|
$ |
(3.21 |
) |
Weighted-average shares
outstanding – basic and diluted |
42,155,981 |
|
|
7,700,371 |
|
|
41,946,852 |
|
|
7,656,077 |
|
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