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 September 30,
2023, and provided recent business highlights.
“We are encouraged by the interim data for SL-172154 in
combination with PLD in a group of PROC patients with advanced
disease. These data are early, and require both additional patients
and longer follow-up, but provide reason for optimism in this study
because an overall response rate of 25-30% with SL-171514 in
combination with PLD is distinct from a benchmark response rate of
4% with PLD alone,” said Taylor Schreiber, M.D., Ph.D., Chief
Executive Officer of Shattuck. “We look forward to sharing data
from our ongoing combination clinical trial with AZA in frontline
HR-MDS and TP53 mutant AML in December.”
SL-172154 Clinical Update: Phase 1B
Clinical Trial of SL-172154 in Combination with PLD in
PROC
Key Takeaways: Observed three partial responses
(one confirmed with 58% reduction in the sum of target lesion
diameters and two unconfirmed with 100% and 31% reductions in the
sum of the target lesion diameters) out of 11 evaluable patients
with PROC for SL-172154 in combination with PLD. The initial data
suggest SL-172154 had an acceptable safety profile in combination
with PLD.
- Data overview: As of
the data cut-off date of October 31, 2023, 16 adult patients with
PROC have been dosed in the ongoing Phase 1B clinical study, of
which 11 patients were evaluable for response. Patients had a
median of 1.5 prior lines of systemic therapy, 47% had bulky
disease measuring >5 cm, 56% were pre-treated with bevacizumab
and 88% were resistant to frontline platinum regimen.
- Preliminary anti-tumor
activity: As of the data cut-off date of October 31, 2023,
three partial responses (one confirmed, two unconfirmed) had been
observed for SL-172154 in combination with PLD. As of November 9,
2023, both patients with unconfirmed partial responses remain on
study and have not reached the date of confirmatory response
assessment.
- Response rate benchmark for
PLD: The patient population treated in this study to date
is similar to the population enrolled in the Pfizer-sponsored
JAVELIN Ovarian 200 clinical trial, wherein PLD monotherapy
provided an overall response rate of 4%.
- SL-172154 plus PLD had an
acceptable safety profile and is consistent with the safety profile
of the individual agents:
- As of the data cut-off date of October
31, 2023, among the 16 treated patients, the most common
SL-172154-related adverse events were infusion related reaction,
nausea, fatigue, headache and neutropenia, mostly in Grade 1-2.
SL-172154-related adverse events in Grade 3 or 4 were observed in 6
patients: anemia (n=2), aspartate aminotransferase increased (n=2),
neutropenia (n=2), alanine aminotransferase increased (n=1),
embolism (n=1) and thrombocytopenia (n=1). SL-172154-related IRRs
occurred in four patients but were manageable and did not prevent
the completion of dosing or lead to discontinuation. There were no
Grade 5 adverse events.
- The Phase 1B combination trial in PROC
of SL-172154 in combination with PLD is using the 3 mg/kg dose of
SL-172154.
- Next steps and anticipated
milestones:
- Completion of planned enrollment of the
Phase 1B dose-expansion cohort of SL-172154 in combination with PLD
in PROC expected in the fourth quarter of 2023.
Upcoming Milestones
SL-172154 (SIRPα-Fc-CD40L)
- Topline data from Phase 1A/B dose
escalation clinical trial of SL-172154 in R/R AML and HR-MDS to be
presented at the 65th ASH Annual Meeting.
- Initial data from the frontline TP53
mutant AML dose-expansion cohort and frontline HR-MDS
dose-expansion cohort combining SL-172154 with AZA 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 mid-year 2024.
- Additional data from the ongoing Phase
1B clinical trial of SL-172154 in combination with PLD in PROC
expected mid-year 2024.
Third Quarter 2023 Recent Business Highlights and Other
Recent Developments
ARC Clinical-Stage Pipeline
SL-172154 (SIRPα-Fc-CD40L)
- Enrollment completed in the
TP53 mutant AML dose expansion cohort of the Phase 1A/B Clinical
Trial of SL-172154 in combination with AZA; enrollment in the
HR-MDS cohort expected to complete in the fourth quarter:
This trial is evaluating SL-172154 in combination with AZA in both
frontline HR-MDS patients and frontline TP53 mutant AML patients.
The data from the dose-escalation portion of the clinical trial in
primarily R/R patients, which preceded the expansion cohorts in
frontline patients, will be presented at the 65th ASH Annual
Meeting. The abstract was made available on November 2, 2023. As of
the May 25, 2023 data cut-off date used for the ASH abstract, 37
patients with R/R AML or HR-MDS had received SL-172154 as
monotherapy or in combination with AZA in the parallel staggered
dose-escalation portion of the clinical trial. Patients had a
median of two prior lines of therapy. As of the data cut-off date
of July 10, 2023 used for efficacy evaluation for the ASH abstract,
a monotherapy response in a R/R AML patient and early signals of
anti-leukemic activity (in the form of blast count reductions) in
patients with R/R AML who received SL-172154 in combination with
AZA were observed in a dose-dependent manner. Early signals of
activity with SL-172154 in combination with AZA in frontline
patients with TP53 mutant HR-MDS were also observed. Out of four
evaluable previously untreated TP53 mutant HR-MDS patients, there
was one complete response, one marrow complete response, and two
stable disease. SL-172154 had an acceptable safety profile as
monotherapy and in combination with AZA. Shattuck remains on track
to share initial data in the fourth quarter of 2023 from the
frontline expansion cohorts in TP53 mutant AML and HR-MDS.
- Continued Dosing of 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) 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 soravtansine, particularly in
patients with tumors that express lower levels of FRα. Shattuck
intends 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 Assay. Shattuck expects to present initial data from
the trial midyear 2024.
Upcoming Events
- Shattuck plans to attend the following
investor conference. Details will be announced prior to the event.
- Evercore ISI HealthCONx Conference
(Miami, FL), November 28-30, 2023
- 65th American Society of Hematology
(ASH) Annual Meeting & Exposition, December 9-12, 2023
- Poster presentation on topline data
from the dose escalation portion of Phase 1A/B clinical trial of
SL-172154 as monotherapy and in combination with AZA in primarily
R/R AML and HR-MDS patients. The full abstract (#4278) is
accessible on the ASH Congress portal and additional details are
provided here.
- Shattuck plans to hold a
company-sponsored event following ASH to discuss complete data from
the dose-escalation portion of the Phase 1A/B clinical trial of
SL-172154 in R/R patients and initial data from the frontline
expansion cohorts in HR-MDS and TP53 mutant AML. Details will be
announced prior to the event.
Conference Call
Shattuck Labs will host a conference call at 8:00 a.m. ET today
to review third quarter 2023 financial results and provide a
general business overview. Investors may participate in the live
call via telephone via the toll-free dial-in (888) 440-4368 and
using the conference ID: 5023003. To listen to the live webcast,
please visit the Investor Relations page of the Shattuck Labs
website here. Participants may register for the call here. While
not required, interested participants are encouraged to join 10
minutes prior to the start of the event.
A replay of the webcast will be available following the
conclusion of the live call and will be accessible on the Company’s
website.
Third-Quarter 2023 Financial Results
- Cash and Cash Equivalents and
Investments: As of September 30, 2023, cash and cash
equivalents and investments were $101.1 million, as compared to
$185.1 million as of September 30, 2022.
- Research and Development
(R&D) Expenses: R&D expenses were $24.2 million
for the quarter ended September 30, 2023, as compared to $18.9
million for the quarter ended September 30, 2022. This increase was
primarily driven by an increase in expense associated with an
increase in clinical trial costs due to increased clinical trial
activity and the manufacture of clinical trial materials to support
the ongoing clinical trials of SL-172154, as well as development
costs for potential pipeline candidates.
- General and Administrative
(G&A) Expenses: G&A expenses were $5.1 million for
the quarter ended September 30, 2023, as compared to $6.6 million
for the quarter ended September 30, 2022. This decrease was
primarily driven by the recognition of a litigation settlement
agreement in the third quarter of 2022.
- Net Loss: Net loss was
$27.5 million for the quarter ended September 30, 2023, or $0.65
per basic and diluted share, as compared to a net loss of $24.6
million for the quarter ended September 30, 2022, or $0.58 per
basic and diluted share.
2023 Financial Guidance
Shattuck 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-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 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 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, the anticipated timing of enrollment in our
clinical trials, anticipated timing for preclinical development
updates, the clinical benefit, safety and tolerability of
SL-172154, 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) |
|
|
September 30, 2023 |
|
December 31,2022 |
|
(unaudited) |
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
40,632 |
|
|
$ |
47,379 |
|
Investments |
|
60,442 |
|
|
|
113,901 |
|
Prepaid expenses and other current assets |
|
11,914 |
|
|
|
23,304 |
|
Total current assets |
|
112,988 |
|
|
|
184,584 |
|
Property and equipment,
net |
|
14,796 |
|
|
|
17,671 |
|
Other assets |
|
2,673 |
|
|
|
3,069 |
|
Total assets |
$ |
130,457 |
|
|
$ |
205,324 |
|
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,016 |
|
|
$ |
7,170 |
|
Accrued expenses and other current liabilities |
|
12,043 |
|
|
|
17,795 |
|
Total current liabilities |
|
14,059 |
|
|
|
24,965 |
|
Non-current operating lease
liabilities |
|
3,615 |
|
|
|
4,202 |
|
Total liabilities |
|
17,674 |
|
|
|
29,167 |
|
Stockholders’ equity: |
|
|
|
Common stock |
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
401,394 |
|
|
|
396,041 |
|
Accumulated other comprehensive loss |
|
7 |
|
|
|
(877 |
) |
Accumulated deficit |
|
(288,623 |
) |
|
|
(219,012 |
) |
Total stockholders’ equity |
|
112,783 |
|
|
|
176,157 |
|
Total liabilities and stockholders’ equity |
$ |
130,457 |
|
|
$ |
205,324 |
|
|
SHATTUCK LABS, INC. CONDENSED 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, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Collaboration revenue |
$ |
686 |
|
|
$ |
212 |
|
|
$ |
943 |
|
|
$ |
262 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
24,211 |
|
|
|
18,862 |
|
|
|
59,083 |
|
|
|
61,012 |
|
General and administrative |
|
5,073 |
|
|
|
6,579 |
|
|
|
14,866 |
|
|
|
16,303 |
|
Expense from operations |
|
29,284 |
|
|
|
25,441 |
|
|
|
73,949 |
|
|
|
77,315 |
|
Loss from operations |
|
(28,598 |
) |
|
|
(25,229 |
) |
|
|
(73,006 |
) |
|
|
(77,053 |
) |
|
|
|
|
|
|
|
|
Other income |
|
1,057 |
|
|
|
594 |
|
|
|
3,395 |
|
|
|
519 |
|
Net loss |
$ |
(27,541 |
) |
|
$ |
(24,635 |
) |
|
$ |
(69,611 |
) |
|
$ |
(76,534 |
) |
Unrealized gain (loss) on
investments |
|
81 |
|
|
|
(226 |
) |
|
|
884 |
|
|
|
(774 |
) |
Comprehensive loss |
$ |
(27,460 |
) |
|
$ |
(24,861 |
) |
|
$ |
(68,727 |
) |
|
$ |
(77,308 |
) |
|
|
|
|
|
|
|
|
Net loss per share – basic and
diluted |
$ |
(0.65 |
) |
|
$ |
(0.58 |
) |
|
$ |
(1.64 |
) |
|
$ |
(1.81 |
) |
Weighted-average shares
outstanding – basic and diluted |
|
42,477,642 |
|
|
|
42,386,470 |
|
|
|
42,461,644 |
|
|
|
42,374,955 |
|
Grafico Azioni Shattuck Labs (NASDAQ:STTK)
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Grafico Azioni Shattuck Labs (NASDAQ:STTK)
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Da Mag 2023 a Mag 2024