Shattuck Labs Reports Fourth Quarter and Full-Year 2023 Financial Results and Recent Business Highlights
29 Février 2024 - 10:05PM
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, 2023 and provided recent business highlights.
“Over the course of 2023, the SL-172154 program rapidly
transitioned from Phase 1A dose-escalation studies to Phase 1B
dose-expansion studies in PROC, HR-MDS, and TP53m AML, which
enabled us to share initial efficacy data in the fourth quarter,”
said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of
Shattuck. “We have now begun 2024 with the momentum and financial
resources to expand our HR-MDS and TP53m AML studies and capitalize
on the potential first-in-class opportunity that now exists in
those indications. We have expanded our ongoing trials, and look
forward to defining our registrational strategy following the next
clinical updates expected mid-year in HR-MDS, AML, and PROC. While
we will remain focused on advancing SL-172154, our pre-clinical
pipeline has continued to mature, as evidenced by our recent
collaboration with Ono, and publications in both Cancer Cell and
Cancer Research. We look forward to providing additional updates
across the portfolio over the course of 2024.”
Clinical Milestones Expected in 2024
SL-172154 (SIRPα-Fc-CD40L)
- Objective response rates and duration
of response based on the then-available data from the Phase 1B
expansion cohorts of SL-172154 in combination with AZA in frontline
HR-MDS and frontline TP53m AML expected mid-year 2024.
- Objective response rate and duration of
response based on the then-available data from the 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.
Fourth Quarter 2023 Business Highlights and Other Recent
Developments
ARC Clinical-Stage Pipeline
SL-172154 (SIRPα-Fc-CD40L)
- Completed Initial Enrollment
and Expanded the Phase 1B Portion of the Ongoing Phase 1A/B
Clinical Trial of SL-172154 in Frontline HR-MDS and Frontline TP53m
AML Patients: This trial is evaluating the safety,
tolerability, pharmacokinetics, anti-tumor activity, and
pharmacodynamic effects of SL-172154 in combination with AZA in
both frontline HR-MDS patients and frontline TP53m AML patients.
The data from the dose-escalation portion of the clinical trial in
primarily relapsed/refractory patients was presented at the 65th
ASH Annual Meeting. Initial data from the dose-expansion portion of
the trial in frontline patients suggest that SL-172154 improved
complete response rates relative to what would be expected
historically with AZA alone in previously untreated HR-MDS
(predominantly TP53m HR-MDS population) and TP53m AML. SL-172154
demonstrated an acceptable safety and tolerability profile both as
monotherapy and in combination with AZA. No destructive anemia was
observed. Objective response rates and duration of response based
on the then-available data from the Phase 1B expansion cohorts of
SL-172154 in combination with AZA in frontline HR-MDS and TP53m AML
are expected mid-year 2024.
- Completed Enrollment of Ongoing
Phase 1B Clinical Trial of SL-172154 in Combination with PLD in
PROC Patients and Presented Positive Interim Data: This
trial 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 PLD in
patients with PROC. The initial data from this Phase 1B clinical
trial in PROC patients was presented in November 2023. Initial data
suggest that SL-172154 improved the response rate relative to what
would be expected from PLD alone. The initial data suggest
SL-172154 had an acceptable safety profile in combination with PLD.
Objective response rate and duration of response based on the
then-available data from the Phase 1B clinical trial of SL-172154
in combination with PLD in PROC are expected mid-year 2024.
- Continued Dosing in Phase 1B
Clinical Trial of SL-172154 in Combination with Mirvetuximab
Soravtansine in PROC Patients. 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 in the United States for PROC patients whose tumors are
shown to be FRα positive, defined as ≥75%, as determined by the
VENTANA FOLR1 (FOLR1-2.1) Assay. Initial combination data from the
Phase 1B clinical trial of SL-172154 in combination with
mirvetuximab soravtansine in PROC is expected mid-year 2024.
Preclinical
- Published Acquired Resistance
(AR) Model in Cancer Cell: In a recent
publication in the journal Cancer Cell, the preclinical development
of a mouse anti-PD1 AR model by Shattuck was shown to closely mimic
the clinical and molecular signatures of those in human patients
with non-small cell lung cancer (NSCLC), who have developed AR to
anti-PD(L)1 therapies, including a dysregulated interferon
response. Findings such as these are important to guide the
identification of new targets and development of new treatment
strategies for this growing unmet need.
- Published Preclinical mRNA Work
in Cancer Research: In a
recent study published in Cancer Research, scientists at Shattuck
and Moderna demonstrated the feasibility of delivering certain
hexameric, dual-sided fusion proteins as lipid-encapsulated mRNA.
The expression level, duration of exposure, and efficacy in a
murine anti-tumor model achieved by the mRNA delivery outperformed
that of the corresponding intravenous administration of recombinant
fusion proteins. These results demonstrated feasibility for
delivery of complex fusion proteins generally, which may have
important pharmacokinetic and pharmacoeconomic benefits for
indications outside of oncology.
Upcoming Events
- Shattuck plans to attend the
following investor or scientific conferences. Details are
included on the Events & Presentations section of the
Company’s website.
- Cowen 44th Annual Health Care
Conference (Boston, MA) March 4-6, 2024
- Leerink Global Biopharma Conference
(Miami, FL) March 11-13, 2024
- Citi's Biotech C-Suite Fireside Chat
Series, held virtually March 20, 2024
- American Association of Cancer Research
Annual Meeting (San Diego, CA) April 5-10, 2024
Corporate Updates
- Shattuck and Ono Enter into
Collaboration Agreement: On February 13, 2024, Shattuck
announced a strategic collaboration and license agreement with Ono
in which Shattuck will lead research and preclinical development of
certain compounds selected by Ono from its pipeline of bifunctional
fusion proteins to a pair of prespecified targets for potential
treatment of autoimmune and inflammatory diseases. Under the terms
of the agreement, Shattuck will receive an up-front payment and be
eligible for success-based licensing, regulatory, and commercial
milestone payments with a total value of up to $227 million, as
well as tiered royalties based on global net sales. Shattuck will
lead discovery research of certain prespecified compounds.
- Shattuck Closes
Financing: On December 21, 2023, Shattuck announced a $50
million public offering of common stock and concurrent private
placement of pre-funded warrants. Net proceeds from the public
offering and the private placement are intended to further support
the development of its pipeline candidates, including SL-172154, as
well as general working capital.
Fourth Quarter and Full-Year 2023 Financial
Results
- Cash and Cash Equivalents and
Investments: As of December 31, 2023 cash and cash
equivalents and investments were $130.6 million, as compared
to $161.3 million as of December 31, 2022.
- Research and Development
(R&D) Expenses: R&D expenses for the quarter ended
December 31, 2023, were $15.2 million, as compared to
$21.9 million for the quarter ended December 31, 2022.
R&D expenses for the year ended December 31, 2023 were
$74.3 million, as compared to $82.9 million for the year
ended December 31, 2022. This decrease was primarily driven by
decreases in the manufacturing of trial materials to support
clinical development of our ongoing clinical trials,
personnel-related costs, and lab supplies but were offset by an
increase in clinical trial cost.
- General and Administrative
(G&A) Expenses: G&A expenses for the quarter ended
December 31, 2023 were $4.4 million, as compared to
$4.8 million for the quarter ended December 31, 2022.
General and administrative expenses for the year ended
December 31, 2023 were $19.3 million, as compared to
$21.1 million for the year ended December 31, 2022. This
decrease for the full year was primarily the result of recognizing
a litigation settlement of $1.4 million in 2022, and the decrease
in the fourth quarter of 2023 was primarily driven by a decrease in
insurance and personnel-related cost.
- Net Loss: Net loss was
$17.7 million for the quarter ended December 31, 2023, or
$0.41 per basic and diluted share, as compared to a net loss of
$25.4 million for the quarter ended December 31, 2022, or
$0.60 per basic share and diluted share. Net loss for the year
ended December 31, 2023 was $87.3 million, or $2.05 per
basic and diluted share, as compared to $101.9 million, or
$2.41 per basic and diluted share, for the year ended
December 31, 2022.
Financial Guidance
Shattuck believes its cash and cash equivalents and investments
will be sufficient to fund its operations into 2026, 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 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, our expectations
regarding plans for our preclinical studies, clinical trials and
research and development programs, plans for expansion of clinical
trials, the anticipated timing of the results from our clinical
trials, 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
FINANCIAL INFORMATIONSHATTUCK LABS,
INC. BALANCE SHEETS(In
thousands) |
|
|
December 31, |
|
|
2023 |
|
|
|
2022 |
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash
equivalents |
$ |
125,626 |
|
|
$ |
47,379 |
|
Investments |
|
4,999 |
|
|
|
113,901 |
|
Prepaid expenses and other current
assets |
|
12,595 |
|
|
|
23,304 |
|
Total current
assets |
|
143,220 |
|
|
|
184,584 |
|
Property and equipment,
net |
|
13,804 |
|
|
|
17,671 |
|
Other
assets |
|
2,540 |
|
|
|
3,069 |
|
Total assets |
$ |
159,564 |
|
|
$ |
205,324 |
|
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts
payable |
$ |
1,587 |
|
|
$ |
7,170 |
|
Accrued expenses and other current
liabilities |
|
9,866 |
|
|
|
17,795 |
|
Total current
liabilities |
|
11,453 |
|
|
|
24,965 |
|
Non-current operating lease
liabilities |
|
3,406 |
|
|
|
4,202 |
|
Total
liabilities |
|
14,859 |
|
|
|
29,167 |
|
Stockholders’ equity: |
|
|
|
Common stock |
|
5 |
|
|
|
5 |
|
Additional paid-in
capital |
|
451,006 |
|
|
|
396,041 |
|
Accumulated other comprehensive income
(loss) |
|
4 |
|
|
|
(877 |
) |
Accumulated
deficit |
|
(306,310 |
) |
|
|
(219,012 |
) |
Total stockholders’
equity |
|
144,705 |
|
|
|
176,157 |
|
Total liabilities and stockholders’
equity |
$ |
159,564 |
|
|
$ |
205,324 |
|
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, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Collaboration
revenue |
$ |
714 |
|
|
$ |
390 |
|
|
$ |
1,657 |
|
|
$ |
652 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and
development |
|
15,227 |
|
|
|
21,887 |
|
|
|
74,310 |
|
|
|
82,899 |
|
General and
administrative |
|
4,438 |
|
|
|
4,779 |
|
|
|
19,304 |
|
|
|
21,082 |
|
Expense from
operations |
|
19,665 |
|
|
|
26,666 |
|
|
|
93,614 |
|
|
|
103,981 |
|
Gain (loss) from
operations |
|
(18,951 |
) |
|
|
(26,276 |
) |
|
|
(91,957 |
) |
|
|
(103,329 |
) |
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
Interest income
(expense) |
|
1,268 |
|
|
|
908 |
|
|
|
4,669 |
|
|
|
1,592 |
|
Other |
|
(4 |
) |
|
|
(43 |
) |
|
|
(10 |
) |
|
|
(208 |
) |
Total other income
(expense) |
|
1,264 |
|
|
|
865 |
|
|
|
4,659 |
|
|
|
1,384 |
|
Net income
(loss) |
$ |
(17,687 |
) |
|
$ |
(25,411 |
) |
|
$ |
(87,298 |
) |
|
$ |
(101,945 |
) |
Unrealized gain (loss) on
investments |
|
(3 |
) |
|
$ |
457 |
|
|
|
881 |
|
|
|
(317 |
) |
Comprehensive gain
(loss) |
$ |
(17,690 |
) |
|
$ |
(24,954 |
) |
|
$ |
(86,417 |
) |
|
$ |
(102,262 |
) |
|
|
|
|
|
|
|
|
Basic and Diluted Per Common
Share Data: |
|
|
|
|
|
|
|
Net earnings (loss) per share
- basic and
diluted |
$ |
(0.41 |
) |
|
$ |
(0.60 |
) |
|
$ |
(2.05 |
) |
|
$ |
(2.41 |
) |
Weighted-average shares
outstanding - basic and
diluted |
|
43,011,310 |
|
|
|
42,390,586 |
|
|
|
42,600,190 |
|
|
|
42,378,895 |
|
Shattuck Labs (NASDAQ:STTK)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Shattuck Labs (NASDAQ:STTK)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024