Shattuck Labs Reports First Quarter 2023 Financial Results and Recent Business Highlights
09 Mayo 2023 - 3:00PM
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, 2023,
and provided recent business highlights.
“As a result of steady clinical progress through the first
quarter of 2023, key efficacy readouts from our ongoing clinical
trials for SL-172154 in PROC and AML/HR-MDS are expected midyear
and in the second half of 2023, respectively. Additionally, our
poster presentation at ASCO next month will provide further context
for our selection of 3 mg/kg which we believe to be the optimal
dose to move into combination trials with liposomal doxorubicin in
patients with PROC. We are further encouraged by ImmunoGen’s
positive Phase 3 confirmatory MIRASOL trial last week, and our
clinical trial of SL-172154 in combination with mirvetuximab
soravtansine is also proceeding nicely,” commented Taylor
Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “I am
also pleased to report that the dose-escalation portion of our
Phase 1 trial in AML/HR-MDS has enrolled very well, and we expect
to complete enrollment in that portion of the study in the second
quarter. We then plan to proceed immediately to the frontline
expansion cohorts in HR-MDS and TP53 mutant AML and to share
initial data from those cohorts in the second half of the year. We
expect that the data both from the dose-escalation and expansion
portions of this trial will help inform what benefit SL-172154 may
provide beyond azacitidine alone.”
Anticipated Milestones
ARC Platform
SL-172154 (SIRPα-Fc-CD40L)
- Complete data from Phase 1A dose-escalation clinical trial of
SL-172154 as monotherapy in PROC to be presented at the 2023 ASCO
annual meeting
- Initial data from Phase 1B clinical trial of SL-172154 in
combination with liposomal doxorubicin in PROC expected midyear
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
of SL-172154 in combination with azacitidine in frontline TP53
mutant AML or HR-MDS cohorts expected in the second half of
2023
- Initial data from Phase 1B clinical trial of SL-172154 in
combination with mirvetuximab soravtansine in PROC expected in the
second half of 2023
GADLEN Platform
GADLEN Preclinical Compounds
- Additional clinical development detail and further program
guidance regarding the advancement of potential product candidates
from the GADLEN platform expected in 2023
First Quarter 2023 Recent Business Highlights and Other
Recent Developments
ARC Clinical-Stage Pipeline
SL-172154 (SIRPα-Fc-CD40L)
- Presenting
Complete Dose-Escalation Data from Phase 1A Monotherapy Clinical
Trial of SL-172154 in PROC at 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. Dose escalation reached a
maximum administered dose of 10 mg/kg.
- Enrollment
Progressing 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 the
dose-escalation portion of this trial, enrollment is complete in
the monotherapy cohorts through 6 mg/kg, and in the combination
cohorts, in combination with azacitidine, through 3 mg/kg. To date,
SL-172154, both alone and in combination, has an acceptable safety
profile. The final dose-escalation cohort of SL-172154 at 6 mg/kg
in combination with azacitidine is expected to complete enrollment
in the second quarter. The trial will then evaluate SL-172154 in
combination with azacitidine in an expansion cohort in frontline
HR-MDS patients and a second expansion cohort in frontline TP53
mutant AML patients. Both expansion cohorts are expected to begin
enrollment in the third quarter of 2023, and we now expect to
complete enrollment in both expansion cohorts during the second
half of 2023. We expect to share full dose-escalation data and
initial data from the frontline expansion cohorts in the second
half 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 expect to present initial data from the trial midyear
2023.
- Dosed First
Patients 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 second half of 2023.
Gamma Delta T Cell Engager (GADLEN) Preclinical
Pipeline
Preclinical Pipeline Development
- We presented preclinical data from our GADLEN platform at the
American Association for Cancer Research (AACR) annual meeting in
April 2023 that demonstrated that the CD20-targeted GADLEN
efficiently directs small numbers of human Vγ9Vδ2 T cells to
serially kill greater than 99% of human B cells in a humanized
mouse model. These results led to the first study of a GADLEN
compound in non-human primates, where once again treatment with a
CD20-targeted GADLEN directed low frequencies of endogenous Vγ9Vδ2
T cells to eliminate CD20 positive B cells with a rapid kinetic.
The GADLEN compound was well tolerated in non-human primates up to
the highest administered dose of 25 mg/kg, without evidence of
cytokine release syndrome or other toxicities, potentially
providing differentiation from CD3-directed T cell engagers.
First-Quarter 2023 Financial Results
- Cash and Cash Equivalents and Investments: As
of March 31, 2023, cash and cash equivalents and investments were
$135.5 million, as compared to $239.2 million as of March 31,
2022.
- Research and Development (R&D)
Expenses: R&D expenses were $16.7 million for the
quarter ended March 31, 2023, as compared to $19.2 million for the
quarter ended March 31, 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 $5.1 million for the quarter ended March 31,
2023, as compared to $5.0 million for the quarter ended March 31,
2022.
- Net Loss: Net loss was $20.7 million for the
quarter ended March 31, 2023, or $0.49 per basic and diluted share,
as compared to a net loss of $24.5 million for the quarter ended
March 31, 2022, or $0.58 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 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 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 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
PART I - FINANCIAL INFORMATION |
Item 1. Financial Statements |
SHATTUCK LABS, INC. CONDENSED
BALANCE SHEETS(In thousands) |
|
|
March 31, 2023 |
December 31, |
|
(unaudited) |
2022 |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
66,043 |
|
$ |
47,379 |
|
Investments |
|
69,452 |
|
|
113,901 |
|
Prepaid expenses and other current assets |
|
22,342 |
|
|
23,304 |
|
Total current assets |
|
157,837 |
|
|
184,584 |
|
Property and equipment,
net |
|
16,887 |
|
|
17,671 |
|
Other assets |
|
2,953 |
|
|
3,069 |
|
Total assets |
$ |
177,677 |
|
$ |
205,324 |
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$ |
5,128 |
|
$ |
7,170 |
|
Accrued expenses and other current liabilities |
|
10,881 |
|
|
17,795 |
|
Total current liabilities |
|
16,009 |
|
|
24,965 |
|
Non-current operating lease
liabilities |
|
4,014 |
|
|
4,202 |
|
Total liabilities |
|
20,023 |
|
|
29,167 |
|
Stockholders’ equity: |
|
|
Common stock |
|
5 |
|
|
5 |
|
Additional paid-in capital |
|
397,724 |
|
|
396,041 |
|
Accumulated other comprehensive loss |
|
(339 |
) |
|
(877 |
) |
Accumulated deficit |
|
(239,736 |
) |
|
(219,012 |
) |
Total stockholders’ equity |
|
157,654 |
|
|
176,157 |
|
Total liabilities and stockholders’ equity |
$ |
177,677 |
|
$ |
205,324 |
|
SHATTUCK LABS, INC. CONDENSED STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited) (In thousands, except share
and per share amounts) |
|
|
Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
Collaboration revenue |
$ |
57 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
Research and development |
|
16,667 |
|
|
|
19,187 |
|
General and administrative |
|
5,051 |
|
|
|
4,979 |
|
Expense from operations |
|
21,718 |
|
|
|
24,166 |
|
Loss from operations |
|
(21,661 |
) |
|
|
(24,166 |
) |
|
|
|
|
Other income (expense) |
|
937 |
|
|
|
(362 |
) |
Net loss |
$ |
(20,724 |
) |
|
$ |
(24,528 |
) |
Unrealized gain on
investments |
|
538 |
|
|
|
33 |
|
Comprehensive loss |
$ |
(20,186 |
) |
|
$ |
(24,495 |
) |
|
|
|
|
Net loss per share – basic and
diluted |
$ |
(0.49 |
) |
|
$ |
(0.58 |
) |
Weighted-average shares
outstanding – basic and diluted |
|
42,439,204 |
|
|
|
42,357,625 |
|
Shattuck Labs (NASDAQ:STTK)
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