Shattuck Labs Reports Second Quarter 2024 Financial Results and Recent Business Highlights
August 01 2024 - 3:05PM
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 quarter ended June 30, 2024 and
provided recent business highlights.
“Our data presentation at EHA last quarter included complete
remission rates for both HR-MDS and TP53m AML patients treated with
SL-172154 in combination with AZA that exceeded the expected
complete remission rates for AZA alone. It is encouraging to see in
our EHA presentation that our complete remission rate improved as
the number of patients in each cohort increased, since our initial
data presented at ASH in December of 2023. The next milestone for
this program is to see how these response rates translate to an
overall survival benefit, and those data will mature over the
second half of this year,” said Taylor Schreiber, M.D., Ph.D.,
Chief Executive Officer of Shattuck. “In parallel, we are pleased
that enrollment has begun so swiftly in our randomized, controlled
expansion cohort in frontline HR-MDS patients. We look forward to
sharing clinical updates from these trials in the months
ahead.”
Second Quarter 2024 Business Highlights and Other Recent
Developments
SL-172154 (SIRPα-Fc-CD40L)
Phase 1B Trial of SL-172154 in Frontline HR-MDS and TP53m
AML
HR-MDS
- Announced updated interim data from the
Phase 1B dose expansion clinical trial of SL-172154 in combination
with AZA in frontline HR-MDS and TP53m AML patients. These data
were featured in a poster presentation during the EHA 2024
Congress.
- Observed 67% Objective Response Rate
(ORR) in frontline HR-MDS patients, primarily with TP53 mutations,
and an initial complete remission (CR)/marrow complete remission
rate of 58%. As of the data cut-off date on April 23, 2024, median
overall survival had not yet been reached.
- SL-172154 demonstrated a manageable interim safety profile in
combination with AZA, with infusion related reactions (IRRs) as the
most common drug related adverse event.
- Initiated enrollment of the Part D
cohort, a randomized, controlled Phase 1B dose-expansion cohort in
frontline HR-MDS patients. Approximately 60 patients will be
randomized in a 1:1:1 ratio to receive SL-172154 at 3mg/kg in
combination with AZA, SL-172154 at 1mg/kg in combination with AZA,
or AZA as monotherapy.
TP53m AML
- Observed 43% ORR in frontline TP53m AML
patients and 33% CR/complete remission rate with incomplete
hematologic recovery. As of the data cut-off date of June 4, 2024,
the median overall survival had not yet been reached. SL-172154
demonstrated a manageable interim safety profile in combination
with AZA.
- In June 2024, the U.S. FDA granted ODD
to SL-172154 for the treatment of AML.
Phase 1B Trial of SL-172154 in Platinum-Resistant Ovarian Cancer
(PROC)
- Reported data from the Phase 1B
clinical trial of SL-172154 in PROC patients, demonstrating an
acceptable safety profile in combination with pegylated liposomal
doxorubicin (PLD) or mirvetuximab soravtansine (Elahere). IRRs were
the most common treatment emergent AE as of the data cutoff.
- As of April 23, 2024, four of 21 (19%)
treated patients in the Phase 1B study of SL-172154 in combination
with PLD achieved partial responses. Two additional patients with
stable disease showed maximum tumor reductions of 17% and 27%.
- Completed enrollment for the cohort
combining SL-172154 with Elahere. As of the April 23, 2024 data
cutoff, ORR benefit beyond Elahere alone was not observed.
- Shattuck continues to follow patients for progression free
survival and overall survival and, should such results mature
favorably in either PROC cohort, will evaluate further development
in PROC at that time.
Corporate Updates
- On July 1, 2024, Shattuck announced its
addition to the Russell 2000® and Russell 3000® Indexes at the
conclusion of the 2024 Russell U.S. Indexes annual
reconstitution.
Upcoming Events
- Shattuck plans to attend the
following investor conferences. Details will be included on the
Events & Presentations section of the
Company’s website.
- BTIG Biotechnology Conference (Virtual)
August 5-6, 2024
- Wells Fargo Healthcare Conference
(Boston, MA) September 4-6, 2024
- H.C. Wainwright 26th Annual Global
Investment Conference (New York, NY) September 9-11, 2024
Second Quarter 2024 Financial Results
- Cash and Cash Equivalents and
Investments: As of June 30, 2024, cash and cash
equivalents and investments were $105.3 million, as compared to
$117.2 million as of June 30, 2023.
- Research and Development
(R&D) Expenses: R&D expenses were $19.2 million
for the quarter ended June 30, 2024, as compared to $18.2 million
for the quarter ended June 30, 2023.
- General and Administrative
(G&A) Expenses: G&A expenses were $5.3 million for
the quarter ended June 30, 2024, as compared to $4.7 million for
the quarter ended June 30, 2023.
- Net Loss: Net loss was
$21.5 million for the quarter ended June 30, 2024, or $0.42 per
basic and diluted share, as compared to a net loss of $21.3 million
for the quarter ended June 30, 2023, or $0.50 per basic and diluted
share.
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 AML, HR-MDS, and PROC.
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 anticipated timing and pace of enrollment in 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 (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, 2023,
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) |
|
|
June 30, 2024 |
|
December 31, 2023 |
|
(unaudited) |
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
60,693 |
|
|
$ |
125,626 |
|
Investments |
|
44,651 |
|
|
|
4,999 |
|
Prepaid expenses and other current assets |
|
9,081 |
|
|
|
12,595 |
|
Total current assets |
|
114,425 |
|
|
|
143,220 |
|
Property and equipment,
net |
|
11,895 |
|
|
|
13,804 |
|
Other assets |
|
2,294 |
|
|
|
2,540 |
|
Total assets |
$ |
128,614 |
|
|
$ |
159,564 |
|
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
2,822 |
|
|
|
1,587 |
|
Deferred revenue |
|
2,997 |
|
|
|
343 |
|
Total current liabilities |
|
15,026 |
|
|
|
11,453 |
|
Non-current operating lease
liabilities |
|
2,972 |
|
|
|
3,406 |
|
Total liabilities |
$ |
17,998 |
|
|
$ |
14,859 |
|
Stockholders’ equity: |
|
|
|
Common stock |
|
5 |
|
|
|
5 |
|
Additional paid in capital |
|
456,982 |
|
|
|
451,006 |
|
Accumulated other comprehensive (loss) income |
|
(5 |
) |
|
|
4 |
|
Accumulated deficit |
|
(346,366 |
) |
|
|
(306,310 |
) |
Total stockholders'
equity |
|
110,616 |
|
|
|
144,705 |
|
Total liabilities and
stockholders' equity |
$ |
128,614 |
|
|
$ |
159,564 |
|
|
|
|
|
|
|
|
|
SHATTUCK LABS, INC. |
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(Unaudited) |
(In thousands, except share and per share
amounts) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Collaboration revenue |
$ |
1,609 |
|
|
$ |
200 |
|
|
$ |
2,724 |
|
|
$ |
257 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
19,239 |
|
|
|
18,205 |
|
|
|
35,503 |
|
|
|
34,872 |
|
General and administrative |
|
5,332 |
|
|
|
4,742 |
|
|
|
10,227 |
|
|
|
9,793 |
|
Expense from operations |
|
24,571 |
|
|
|
22,947 |
|
|
|
45,730 |
|
|
|
44,665 |
|
Loss from operations |
|
(22,962 |
) |
|
|
(22,747 |
) |
|
|
(43,006 |
) |
|
|
(44,408 |
) |
Other income |
|
1,410 |
|
|
|
1,401 |
|
|
|
2,950 |
|
|
|
2,338 |
|
Net loss |
$ |
(21,552 |
) |
|
$ |
(21,346 |
) |
|
$ |
(40,056 |
) |
|
$ |
(42,070 |
) |
Unrealized gain (loss) on
investments |
|
9 |
|
|
|
265 |
|
|
|
(9 |
) |
|
|
803 |
|
Comprehensive loss |
$ |
(21,543 |
) |
|
$ |
(21,081 |
) |
|
$ |
(40,065 |
) |
|
$ |
(41,267 |
) |
|
|
|
|
|
|
|
|
Net loss per share – basic and
diluted |
$ |
(0.42 |
) |
|
$ |
(0.50 |
) |
|
$ |
(0.79 |
) |
|
$ |
(0.99 |
) |
Weighted-average shares
outstanding – basic and diluted |
|
50,791,241 |
|
|
|
42,467,664 |
|
|
|
50,678,818 |
|
|
|
42,453,513 |
|
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