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 June 30, 2023, and
provided recent business highlights.
“We are pleased with our continued progress in enrollment in our
ongoing trials in the second quarter of 2023, and in particular to
now have four different expansion cohorts well underway in our
AML/HR-MDS and PROC trials,” said Taylor Schreiber, M.D., Ph.D.,
Chief Executive Officer of Shattuck. “We believe that data from our
dose-escalation study in PROC presented at ASCO demonstrated that
SL-172154 may be a differentiated CD47 inhibitor due to the
integrated CD40 agonist function, and we look forward to sharing
initial combination data across multiple tumors and lines of
therapy by the end of the year.”
2023 Anticipated Milestones
ARC Platform
SL-172154 (SIRPα-Fc-CD40L)
- Complete enrollment and initial data from the ongoing Phase 1B
clinical trial of SL-172154 in combination with liposomal
doxorubicin in PROC expected in the fourth quarter of 2023.
- Initial data from the ongoing Phase 1B clinical trial of
SL-172154 in combination with mirvetuximab soravtansine in PROC
expected in the fourth quarter of 2023.
- Complete dose-escalation data, as monotherapy and in
combination with azacitidine, for Phase 1A clinical trial of
SL-172154 in primarily relapsed/refractory AML and HR-MDS expected
in the fourth quarter of 2023.
- Completion of enrollment in the frontline TP53 mutant AML
dose-expansion cohort and frontline HR-MDS dose-expansion cohort
from our ongoing Phase 1A/B clinical trial of SL-172154 and initial
data expected in the fourth quarter of 2023.
Second Quarter 2023 Recent Business Highlights and Other
Recent Developments
ARC Clinical-Stage Pipeline
SL-172154 (SIRPα-Fc-CD40L)
- Presented Complete Dose-Escalation Data from Phase 1A
Monotherapy Clinical Trial of SL-172154 in PROC at the 2023 ASCO
Annual Meeting: This open-label, multi-center,
dose-escalation clinical trial evaluated the safety, tolerability,
pharmacokinetics, anti-tumor activity, and pharmacodynamic effects
of SL-172154 administered intravenously in patients with PROC.
SL-172154 had near-full CD47 and CD40 target engagement and
CD40-dependent pharmacodynamic effects observed at the 3 mg/kg
dose. SL-172154 had a favorable safety and tolerability profile
across doses. The best response per RECIST 1.1 was stable disease
in six (22%) patients.
- Completed Enrollment in Dose-escalation Portion of
Phase 1A/B Clinical Trial of SL-172154 in AML and HR-MDS:
This trial is evaluating the safety, tolerability,
pharmacokinetics, anti-tumor activity, and pharmacodynamic effects
of SL-172154 as both monotherapy and in combination with
azacitidine. In the dose-escalation portion of this trial,
enrollment is complete. We are now enrolling patients in the dose
expansion cohorts, evaluating SL-172154 in combination with
azacitidine in both frontline HR-MDS patients and in frontline TP53
mutant AML. We expect to complete enrollment for the two expansion
cohorts in the fourth quarter of 2023. We expect to share complete
data from the dose-escalation portion of the trial and initial data
from the frontline expansion cohorts in the fourth quarter of
2023.
- Enrollment Progressing in Phase 1B Clinical Trial of
SL-172154 in Combination with Liposomal Doxorubicin in
PROC: Enrollment is continuing in this trial, which is
evaluating the safety, tolerability, pharmacokinetics, anti-tumor
activity, and pharmacodynamic effects of SL-172154, using the
selected dose of 3 mg/kg, in combination with liposomal doxorubicin
in patients with PROC. We completed enrollment in the safety run in
portion of this trial in the second quarter of 2023 and expect to
complete enrollment in the expansion cohort and present initial
data from the trial in the fourth quarter of 2023.
- Enrollment Progressing in Phase 1B Clinical Trial of
SL-172154 in Combination with Mirvetuximab Soravtansine in
PROC. This trial is evaluating the safety,
pharmacokinetics, pharmacodynamic effects, and preliminary
anti-tumor activity of SL-172154 administered in combination with
mirvetuximab soravtansine in patients with PROC. Mirvetuximab
soravtansine is an antibody-drug conjugate targeting folate
receptor alpha (FRα), which provides for both direct tumor cell
killing as well as enhanced macrophage phagocytosis through binding
with Fc gamma receptors and has received accelerated approval for
PROC patients whose tumors are shown to be FRα positive, defined as
≥75%, as determined by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay.
Preclinical studies have shown that both of these killing
mechanisms are complementary to the mechanism of SL-172154 by
enhancing the activity of macrophages to phagocytose FRα-
expressing ovarian cancer cells, and that SL-172154 may broaden the
activity of mirvetuximab, particularly in patients with tumors that
express lower levels of FRα. We intend to enroll patients with
broader FRα expression, including those with “high” (greater than
≥75%), “medium” (≥50% to <75%), and “low” (≥25% to <50%)
expression of FRα, as determined by the VENTANA FOLR1 (FOLR1-2.1).
We expect to present initial data from the trial in the fourth
quarter of 2023.
Gamma Delta T Cell Engager (GADLEN)
Platform
GADLEN Preclinical Compounds
- In an initial non-human primate toxicology study, presented at
the 2023 Annual Meeting of the American Association for Cancer
Research, we observed dose-dependent B cell depletion following
administration of a CD20-directed GADLEN. Subsequently, in the
second quarter of 2023, we performed an additional toxicology study
in non-human primates that was designed to expand upon the initial
non-human primate study. In this second study, the depth and
durability of B cell depletion were inferior to that reported in
published studies with other B cell depleting agents. We are
working to determine the underlying scientific cause for these
differences in B cell response, and whether these are due to
species differences between humans and cynomolgus macaques, or due
to aspects inherent to gamma delta T cell biology. We do not
currently plan to file an Investigational New Drug application for
any GADLEN compounds until these data are better understood.
Second-Quarter 2023 Financial Results
- Cash and Cash Equivalents and Investments: As
of June 30, 2023, cash and cash equivalents and investments were
$117.2 million, as compared to $214.2 million as of June 30,
2022.
- Research and Development (R&D) Expenses:
R&D expenses were $18.2 million for the quarter ended June 30,
2023, as compared to $23.0 million for the quarter ended June 30,
2022. This decrease was primarily driven by a decrease in expense
associated with the manufacture of clinical trial materials to
support our ongoing clinical trials.
- General and Administrative (G&A)
Expenses: G&A expenses were $4.7 million for the
quarter ended June 30, 2023, as compared to $4.7 million for the
quarter ended June 30, 2022.
- Net Loss: Net loss was $21.3 million for the
quarter ended June 30, 2023, or $0.50 per basic and diluted share,
as compared to a net loss of $27.4 million for the quarter ended
June 30, 2022, or $0.65 per basic and diluted share.
2023 Financial GuidanceShattuck believes its
cash and cash equivalents and investments will be sufficient to
fund its operations through year-end 2024, beyond results from its
Phase 1 clinical trials of SL-172154. This cash runway guidance is
based on the Company’s current operational plans and excludes any
additional capital that may be received, proceeds from business
development transactions, and/or additional costs associated with
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. Multiple Phase 1 clinical trials are
ongoing for patients with PROC (NCT04406623, NCT05483933) and
patients with AML and HR-MDS (NCT05275439).
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 are designed to
simultaneously inhibit checkpoint molecules and activate
costimulatory molecules with a single therapeutic. The company’s
lead 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 multiple Phase 1 trials. 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, plans for clinical trial design, the anticipated timing
of the results from our preclinical studies and clinical trials,
anticipated timing of enrollment in our clinical trials,
anticipated timing for preclinical development updates, potential
safety and 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: global macroeconomic
conditions and related volatility, 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, 2022,
and subsequent disclosure documents filed 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
RichardsonVice President of Investor RelationsShattuck Labs,
Inc.InvestorRelations@shattucklabs.com
SHATTUCK LABS, INC.
CONDENSED BALANCE SHEETS(In
thousands)
|
June 30, 2023 |
December 31, |
|
(unaudited) |
2022 |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
71,893 |
|
|
$ |
47,379 |
|
Investments |
|
45,279 |
|
|
|
113,901 |
|
Prepaid expenses and other current assets |
|
19,278 |
|
|
|
23,304 |
|
Total current assets |
|
136,450 |
|
|
|
184,584 |
|
Property and equipment,
net |
|
16,015 |
|
|
|
17,671 |
|
Other assets |
|
2,805 |
|
|
|
3,069 |
|
Total assets |
$ |
155,270 |
|
|
$ |
205,324 |
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$ |
2,011 |
|
|
$ |
7,170 |
|
Accrued expenses and other current liabilities |
|
10,983 |
|
|
|
17,795 |
|
Total current liabilities |
|
12,994 |
|
|
|
24,965 |
|
Non-current operating lease
liabilities |
|
3,818 |
|
|
|
4,202 |
|
Total liabilities |
|
16,812 |
|
|
|
29,167 |
|
Stockholders’ equity: |
|
|
Common stock |
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
399,609 |
|
|
|
396,041 |
|
Accumulated other comprehensive loss |
|
(74 |
) |
|
|
(877 |
) |
Accumulated deficit |
|
(261,082 |
) |
|
|
(219,012 |
) |
Total stockholders’ equity |
|
138,458 |
|
|
|
176,157 |
|
Total liabilities and stockholders’ equity |
$ |
155,270 |
|
|
$ |
205,324 |
|
SHATTUCK LABS, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS (Unaudited) (In thousands,
except share and per share amounts)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Collaboration revenue |
$ |
200 |
|
|
$ |
50 |
|
|
$ |
257 |
|
|
$ |
50 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
18,205 |
|
|
|
22,963 |
|
|
|
34,872 |
|
|
|
42,150 |
|
General and administrative |
|
4,742 |
|
|
|
4,745 |
|
|
|
9,793 |
|
|
|
9,724 |
|
Expense from operations |
|
22,947 |
|
|
|
27,708 |
|
|
|
44,665 |
|
|
|
51,874 |
|
Loss from operations |
|
(22,747 |
) |
|
|
(27,658 |
) |
|
|
(44,408 |
) |
|
|
(51,824 |
) |
|
|
|
|
|
|
|
|
Other income (expense) |
|
1,401 |
|
|
|
287 |
|
|
|
2,338 |
|
|
|
(75 |
) |
Net loss |
$ |
(21,346 |
) |
|
$ |
(27,371 |
) |
|
$ |
(42,070 |
) |
|
$ |
(51,899 |
) |
Unrealized gain (loss) on
investments |
|
265 |
|
|
|
(581 |
) |
|
|
803 |
|
|
|
(548 |
) |
Comprehensive loss |
$ |
(21,081 |
) |
|
$ |
(27,952 |
) |
|
$ |
(41,267 |
) |
|
$ |
(52,447 |
) |
|
|
|
|
|
|
|
|
Net loss per share – basic and
diluted |
$ |
(0.50 |
) |
|
$ |
(0.65 |
) |
|
$ |
(0.99 |
) |
|
$ |
(1.22 |
) |
Weighted-average shares
outstanding – basic and diluted |
|
42,467,664 |
|
|
|
42,380,454 |
|
|
|
42,453,513 |
|
|
|
42,369,102 |
|
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