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, 2022 and provided recent business highlights.
“During the fourth quarter of 2022, we continued to focus on
clinical execution to position ourselves for key clinical data
readouts for SL-172154 in 2023. Enrollment in our AML/HR-MDS
clinical trial of SL-172154 is moving along nicely, and, in the
fourth quarter, we advanced into the first combination cohort with
azacitidine. This keeps us on track to share initial data from the
dose-escalation portion of this trial from relapsed/refractory
AML/HR-MDS patients both as monotherapy and in combination
with azacitidine in the first half of 2023. As it relates to our
trials in platinum-resistant ovarian cancer, in early 2022 we
established a collaboration with ImmunoGen to combine SL-172154
with mirvetuximab soravtansine and, in the fourth quarter, we
initiated enrollment in this Phase 1B clinical trial. We expect
initial data from the combination trial with SL-172154 and
liposomal doxorubicin midyear 2023, and we expect initial data from
the combination trial of SL-172154 and mirvetuximab soravtansine in
the second half of 2023,” said Taylor Schreiber, M.D., Ph.D., and
Chief Executive Officer of Shattuck. “I am also very pleased to
announce the promotion of Dr. George Fromm to CSO of the ARC
platform and Dr. Suresh de Silva to CSO of the GADLEN platform. We
look forward to benefiting from the expertise of these scientific
program leaders as we continue our momentum in 2023. Drs. Fromm and
de Silva have been invaluable to Shattuck from the time they each
joined the company in 2017, and they will continue to play a
critical role as we build-out our pipeline over the coming years.
2023 is an important year for Shattuck, with multiple data
readouts, which we believe will establish SL-172154 as both a
differentiated CD47 inhibitor and a CD40 agonist capable of
activating the CD40 pathway in human cancer patients. We expect
that these data will position Shattuck well for continued growth in
the years ahead.”
“After enrolling patients in the final dose levels of 12 and 24
mg/kg with the SL-279252 clinical program, and not meeting a
stringent efficacy threshold required to justify further
development, we have decided to discontinue development of
SL-279252. The development program for SL-279252 has yielded
tremendously important preclinical, translational, and clinical
data for the ARC platform, and we thank the patients and their
families for participating in our clinical trial. We remain focused
on delivering novel therapeutics that benefit patients with cancer
with high unmet need and look forward to the combination data in
both of our ongoing clinical trials with SL-172154 in the coming
quarters,” continued Dr. Schreiber.
Clinical Milestones Expected in 2023
ARC Platform
SL-172154 (SIRPα-Fc-CD40L)
- Complete data from Phase 1A
dose-escalation clinical trial of SL-172154 as monotherapy in
platinum-resistant ovarian cancer expected midyear 2023
- Initial data from Phase 1B clinical
trial of SL-172154 in combination with liposomal doxorubicin in
platinum-resistant ovarian cancer expected midyear 2023
- Initial dose-escalation data, as
monotherapy and in combination with azacitidine, for Phase 1A/B
clinical trial of SL-172154 in relapsed/refractory AML and HR-MDS
expected in the first half of 2023
- Complete dose-escalation data, as
monotherapy and in combination with azacitidine, for Phase 1A/B
clinical trial of SL-172154 in AML and HR-MDS and initial
dose-expansion cohort data with SL-172154 in combination with
azacitidine in frontline TP53 mutant AML and HR-MDS expected in the
second half of 2023
- Initial data from Phase 1B clinical
trial of SL-172154 in combination with mirvetuximab soravtansine in
platinum-resistant ovarian cancer expected in the second half of
2023
GADLEN Platform
GADLEN Preclinical Compounds
- Additional detail and further program
guidance regarding the advancement of potential product candidates
from the GADLEN platform expected in 2023
Fourth Quarter 2022 Recent Business Highlights and Other
Recent Developments
ARC Clinical-Stage Pipeline
SL-172154 (SIRPα-Fc-CD40L)
- Completed Phase 1A Monotherapy
Dose-Escalation Clinical Trial of SL-172154 in Platinum-Resistant
Ovarian Cancer: 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 advanced
platinum-resistant ovarian cancer. We reached a maximum
administered dose of 10.0 mg/kg and expect to present complete
dose-escalation data from the trial midyear 2023.
- Dosed First Patients in First
Combination Cohort with Azacitidine in Ongoing Phase 1A/B Clinical
Trial 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. In AML, SL-172154 may be evaluated in combination with
azacitidine and venetoclax. In both HR-MDS and TP53 mutant AML,
SL-172154 may be evaluated in combination with azacitidine.
Patients have been dosed in both the monotherapy and combination
dose-escalation cohorts of this trial and enrollment is ongoing.
Dose escalation will continue in a parallel staggered manner, and
initial dose-escalation data, as monotherapy and in combination
with azacitidine, are expected in the first half of 2023.
- Enrollment Progressing in Phase
1B Clinical Trial of SL-172154 in Combination with Liposomal
Doxorubicin in Advanced Platinum-Resistant Ovarian Cancer:
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
3.0 mg/kg, in combination with liposomal doxorubicin in
patients with advanced platinum-resistant ovarian cancer. We expect
to present initial data from this trial in combination with
liposomal doxorubicin midyear 2023.
- Initiated Enrollment in Phase
1B Clinical Trial of SL-172154 in Combination with Mirvetuximab
Soravtansine in Advanced Platinum-Resistant Ovarian
Cancer. This trial is evaluating the safety,
pharmacokinetics, pharmacodynamic effects, and preliminary
anti-tumor activity of SL-172154 administered in combination with
mirvetuximab soravtansine in subjects with platinum-resistant
ovarian, primary peritoneal, or fallopian tube cancers.
Mirvetuximab soravtansine is an antibody-drug conjugate targeting
folate receptor alpha, or 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 platinum-resistant ovarian cancer patients whose
tumors are shown to be FRα positive, defined as ≥75%, as determined
by the VENTANA FOLR1 (FOLR1-2.1) Assay, using the PS2+ scoring
method. Pre-clinical 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 soravtansine, 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% of tumor cells staining with 2+ intensity),
“medium” (≥50% to <75% of tumor cells staining with 2+
intensity) , and “low” (≥25% to <50% of tumor cells staining
with 2+ intensity) expression of FRα, as determined by the VENTANA
FOLR1 (FOLR1-2.1) Assay, using the PS2+ scoring method. We
expect to present initial data from this trial in combination with
mirvetuximab soravtansine in the second half of 2023.
SL-279252 (PD1-Fc-OX40L)
- Completed Phase 1 Dose
Escalation Clinical Trial of SL-279252 in Advanced Solid Tumors and
Announces Discontinuation of Clinical Development of the SL-279252
Program: In the fourth quarter of 2021, we reported
initial data from this trial demonstrating evidence of initial
anti-tumor activity and dose-dependent pharmacodynamic activity. As
previously stated, our internal benchmark for continued program
development of SL-279252 was response rates equal or exceeding 20%
in the 12 and 24 mg/kg cohorts. We did not observe an overall
response rate necessary to justify continued development in a very
difficult PD-1 relapsed/refractory patient population, and we are
announcing the discontinuation of clinical development of
SL-279252.
Gamma Delta T Cell Engager (GADLEN) Preclinical
Pipeline
Preclinical Pipeline Development
- Announced two potential product
candidates, currently in preclinical development, from the GADLEN
platform—one targeting the CD20 antigen intended for development in
autoimmune disease, and a second targeting the B7-H3 antigen for
development in oncology: As Shattuck advances its
preclinical pipeline, we anticipate further program guidance
regarding the advancement of potential product candidates from the
GADLEN platform in 2023.
Corporate Update
- Appointed CSOs for ARC and
GADLEN Platforms: In January 2023, Dr. George Fromm was
promoted to CSO of the ARC platform, and Dr. Suresh de Silva was
promoted to CSO of the GADLEN platform. Dr. Fromm joined Shattuck
Labs in 2017 and is one of its scientific co-founders. He
previously served as Shattuck’s Vice President of R&D and
co-led the preclinical development of SL-279252 and SL-172154 into
clinical trials. Earlier, Dr. Fromm served as the Senior Director
of Research and Development at Heat Biologics, Inc., where he
directed the discovery and clinical-based research efforts for
their phase I/II trials and co-invented a “next-generation” vaccine
platform that combines a cell-based immunotherapy vaccine and a T
cell costimulatory fusion protein in a single treatment. Dr. de
Silva previously served as Shattuck’s Vice President of Product
Development from 2018-2022 and as Shattuck’s Executive Director of
Research and Development from 2017 to 2018. Dr. de Silva joined
Shattuck in 2017 and is one of its scientific co-founders and
co-led the preclinical development of SL-279252 and SL-172154.
Prior to joining Shattuck, Dr. de Silva served as the Director of
Research and Development at Heat Biologics, Inc. in Durham, NC,
where he led external research collaborations and co-developed the
ComPact cell-based vaccine platform.
Upcoming Events
- American Association for Cancer
Research Annual Meeting (AACR), April 14-19, 2023
- 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.
- Cowen 43rd Annual Healthcare
Conference, March 6-8, 2023
- Oppenheimer 33rd Annual Healthcare
Conference, March 13-15, 2023
- Needham 22nd Annual Healthcare
Conference, April 17-20, 2023
Fourth-Quarter and Full-Year 2022 Financial
Results
- Cash Position: As of
December 31, 2022, cash and cash equivalents and investments were
$161.3 million, as compared to $268.8 million as of December 31,
2021.
- Research and Development
(R&D) Expenses: R&D expenses for the quarter ended
December 31, 2022 were $21.9 million, as compared to $16.2 million
for the quarter ended December 31, 2021. R&D expenses for the
year ended December 31, 2022 were $82.9 million, as compared to
$56.6 million for the year ended December 31, 2021. This increase
was primarily driven by increases in manufacturing of trial
materials to support clinical development of our ongoing clinical
trials, personnel-related costs, and lab supplies.
- General and Administrative
(G&A) Expenses: G&A expenses for the quarter ended
December 31, 2022 were $4.8 million, as compared to $4.6 million
for the quarter ended December 31, 2021. General and administrative
expenses for the year ended December 31, 2022 were $21.1 million,
as compared to $18.7 million for the year ended December 31, 2021.
This increase was primarily driven by a litigation settlement of
$1.4 million and increases in personnel-related and other operating
costs.
- Net Loss: Net loss was
$25.4 million for the quarter ended December 31, 2022, or $0.60 per
basic and diluted share, as compared to a net income of $7.8
million for the quarter ended December 31, 2021, or $0.19 per basic
share and $0.18 per diluted share. Net loss for the year ended
December 31, 2022 was $101.9 million, or $2.41 per basic and
diluted share, as compared to $45.0 million, or $1.07 per basic and
diluted share, for the year ended December 31, 2021.
2023 Financial Guidance
Shattuck believes its cash and cash equivalents and 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.
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-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. Multiple Phase 1 clinical trials are ongoing for patients
with advanced platinum-resistant ovarian cancer (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 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. 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, plans for clinical trial design,
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: 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
FINANCIAL INFORMATION
SHATTUCK LABS, INC.
BALANCE SHEETS
(In thousands)
|
December 31, |
|
|
2022 |
|
|
|
2021 |
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
47,379 |
|
|
$ |
92,268 |
|
Investments |
|
113,901 |
|
|
|
176,536 |
|
Prepaid expenses and other current assets |
|
23,304 |
|
|
|
19,462 |
|
Total current assets |
|
184,584 |
|
|
|
288,266 |
|
Property and equipment,
net |
|
17,671 |
|
|
|
9,938 |
|
Other assets |
|
3,069 |
|
|
|
381 |
|
Total assets |
$ |
205,324 |
|
|
$ |
298,585 |
|
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
7,170 |
|
|
$ |
10,012 |
|
Accrued expenses and other current liabilities |
|
17,795 |
|
|
|
14,574 |
|
Total current liabilities |
|
24,965 |
|
|
|
24,586 |
|
Non-current operating lease
liabilities |
|
4,202 |
|
|
|
— |
|
Deferred rent |
|
— |
|
|
|
2,213 |
|
Total liabilities |
|
29,167 |
|
|
|
26,799 |
|
Stockholders’ equity: |
|
|
|
Common stock |
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
396,041 |
|
|
|
389,408 |
|
Accumulated other comprehensive loss |
|
(877 |
) |
|
|
(560 |
) |
Accumulated deficit |
|
(219,012 |
) |
|
|
(117,067 |
) |
Total stockholders’ equity |
|
176,157 |
|
|
|
271,786 |
|
Total liabilities and stockholders’ equity |
$ |
205,324 |
|
|
$ |
298,585 |
|
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, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Collaboration revenue |
$ |
390 |
|
|
$ |
30,078 |
|
|
$ |
652 |
|
|
$ |
30,017 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
21,887 |
|
|
|
16,207 |
|
|
|
82,899 |
|
|
|
56,563 |
|
General and administrative |
|
4,779 |
|
|
|
4,624 |
|
|
|
21,082 |
|
|
|
18,723 |
|
Expense from operations |
|
26,666 |
|
|
|
20,831 |
|
|
|
103,981 |
|
|
|
75,286 |
|
Gain (loss) from
operations |
|
(26,276 |
) |
|
|
9,247 |
|
|
|
(103,329 |
) |
|
|
(45,269 |
) |
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
Interest income (expense) |
|
908 |
|
|
|
(1,321 |
) |
|
|
1,592 |
|
|
|
625 |
|
Other |
|
(43 |
) |
|
|
(79 |
) |
|
|
(208 |
) |
|
|
(330 |
) |
Total other income (expense) |
|
865 |
|
|
|
(1,400 |
) |
|
|
1,384 |
|
|
|
295 |
|
Net income (loss) |
$ |
(25,411 |
) |
|
$ |
7,847 |
|
|
$ |
(101,945 |
) |
|
$ |
(44,974 |
) |
Unrealized gain (loss) on investments |
|
457 |
|
|
|
1,267 |
|
|
|
(317 |
) |
|
|
(497 |
) |
Comprehensive gain (loss) |
$ |
(24,954 |
) |
|
$ |
9,114 |
|
|
$ |
(102,262 |
) |
|
$ |
(45,471 |
) |
|
|
|
|
|
|
|
|
Basic and Diluted Per Common
Share Data: |
|
|
|
|
|
|
|
Net earnings (loss) per share
- basic |
$ |
(0.60 |
) |
|
$ |
0.19 |
|
|
$ |
(2.41 |
) |
|
$ |
(1.07 |
) |
Weighted-average shares
outstanding - basic |
|
42,390,586 |
|
|
|
42,286,190 |
|
|
|
42,378,895 |
|
|
|
42,032,384 |
|
Net earnings (loss) per share
- diluted |
$ |
(0.60 |
) |
|
$ |
0.18 |
|
|
$ |
(2.41 |
) |
|
$ |
(1.07 |
) |
Weighted-average shares
outstanding - diluted |
|
42,390,586 |
|
|
|
44,734,866 |
|
|
|
42,378,895 |
|
|
|
42,032,384 |
|
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