Shattuck Labs Provides Corporate Update and Highlights Upcoming Key Milestones in 2024
January 08 2024 - 7:00AM
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
provided a corporate update and highlighted upcoming key milestones
anticipated in 2024.
“In 2023, we delivered key safety and efficacy
data across our clinical development program for SL-172154 and
further strengthened our financial resources, which we believe will
carry us beyond upcoming milestones in the year ahead,” said Taylor
Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck Labs.
“Based on preliminary results demonstrating initial anti-tumor
activity and an acceptable safety and tolerability profile across
several indications, we believe SL-172154 has first-in-class
opportunities in HR-MDS, AML, and ovarian cancer. Our recent
financing enables the expansion of our trial in HR-MDS and TP53m
AML and acceleration of other regulatory and manufacturing
activities to support our discussions in 2024 regarding potential
registrational development plans. These are all indications with
significant unmet medical need, and we will maintain our current
operational efficiency and focus to drive shareholder value in the
year ahead.”
Key Accomplishments in 2023
Clinical Accomplishments
Platinum-Resistant Ovarian Cancer (PROC)
- Presented complete data from the Phase 1A clinical trial of
SL-172154 as monotherapy in PROC at the American Society of
Clinical Oncology 2023 annual meeting, including data supporting 3
mg/kg as an appropriate dose of SL-172154 for each PROC combination
cohort.
- Completed enrollment of and presented positive interim data
from the Phase 1B clinical trial of SL-172154 in combination with
pegylated liposomal doxorubicin (PLD) in PROC.
- Demonstrated an acceptable safety profile and encouraging
anti-tumor activity that compares favorably to PLD as a
monotherapy.
- Enrollment continued to progress in the Phase 1B clinical trial
of SL-172154 in combination with mirvetuximab soravtansine in
PROC.
Higher-Risk Myelodysplastic Syndromes
(HR-MDS) and Acute Myeloid Leukemia (AML)
- Presented results from the dose escalation portion of the Phase
1A/B clinical trial of SL-172154 in relapsed/refractory (R/R) AML
and HR-MDS and frontline TP53 mutant (TP53m) HR-MDS patients as
monotherapy and in combination with azacitidine (AZA) in a poster
presentation at the American Society of Hematology Annual Meeting.
- Anti-leukemic responses were observed with SL-172154 as
monotherapy and in combination with AZA. SL-172154 alone and in
combination with AZA had an acceptable safety profile, consistent
with the safety profile of the individual agents. No destructive
anemia was observed.
- Completed enrollment in frontline expansion cohort in TP53m AML
patients and in the frontline expansion cohort in HR-MDS
patients.
- Presented positive initial topline data from the ongoing Phase
1A/B dose expansion clinical trial of SL-172154 with AZA in
frontline HR-MDS and TP53m AML patients.
- Initial data suggest SL-172154 improved complete response rates
relative to what would be expected historically with AZA alone in
previously untreated HR-MDS and TP53m AML. SL-172154 demonstrated
an acceptable safety and tolerability profile both as monotherapy
and in combination with AZA.
Corporate Accomplishments
- On December 21, 2023, Shattuck announced a $50 million
registered offering of common stock and concurrent private
placement of pre-funded warrants. Net proceeds from the registered
offering and the private placement are intended to further support
the development of its pipeline candidates, including
SL-172154.
Clinical Milestones Expected in
2024
- Complete objective response rates and initial duration of
response data from the ongoing Phase 1B clinical trial of SL-172154
in combination with PLD in PROC expected mid-year 2024.
- Initial combination data from the Phase 1B clinical trial of
SL-172154 in combination with mirvetuximab soravtansine in PROC
expected mid-year 2024.
- Complete objective response rates and initial duration of
response data from the Phase 1B expansion cohorts of SL-172154 in
combination with AZA in frontline TP53m AML and HR-MDS expected
mid-year 2024.
Cash Position and Financial
Guidance Shattuck ended the third quarter of 2023 with
approximately $101.1 million in cash and cash equivalents and
investments. The company expects its cash and cash equivalents and
investments as of September 30, 2023, together with the proceeds
from the $50 million registered offering of common stock and
concurrent private placement of pre-funded warrants in December of
2023, to be sufficient to fund operations into 2026.
Upcoming Presentations
Conference: 42nd Annual J.P. Morgan Healthcare Conference
Format: Corporate Presentation Presenter: Taylor Schreiber,
M.D., Ph.D., Shattuck’s Chief Executive Officer Date: January
11, 2024 Time: 12:00 p.m. PT Location: Westin St.
Francis, San Francisco, CA
A live webcast of the presentation will be
available on the Events & Presentations section of
the company’s website. A replay of the webcast will be archived for
up to 30 days following the presentation date.
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 and patients
with AML and HR-MDS.
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, the clinical
benefit of SL-172154 in frontline HR-MDS and TP53m AML patients,
the safety and tolerability profile of SL-172154, the anticipated
timing of additional data from Shattuck’s clinical trials,
enrollment and potential expansion of the company’s clinical
trials, the use of proceeds from the company’s recent financing
transaction, and statements regarding Shattuck’s anticipated cash
runway. 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 the company believes 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 the company 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
Shattuck’s filings with the U.S. Securities and Exchange Commission
(SEC)), many of which are beyond the company’s control and subject
to change. Actual results could be materially different. Risks and
uncertainties which could cause such outcomes to change include:
global macroeconomic conditions and related volatility,
expectations regarding the initiation, progress, and expected
results of Shattuck’s preclinical studies, clinical trials and
research and development programs; expectations regarding the
timing, completion and outcome of the company’s 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 Shattuck’s Annual Report on
Form 10-K for the year ended December 31, 2022 and subsequent
disclosure documents filed with the SEC. Shattuck claims the
protection of the Safe Harbor contained in the Private Securities
Litigation Reform Act of 1995 for forward-looking statements.
Shattuck expressly disclaims 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 Richardson Vice President of Investor Relations Shattuck
Labs, Inc. InvestorRelations@shattucklabs.com
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