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, 2022
and provided recent business highlights.
“We are pleased to have completed the monotherapy
dose-escalation trial with SL-172154 in platinum-resistant ovarian
cancer and to have advanced to the combination phase of clinical
development for SL-172154 in both platinum-resistant ovarian cancer
and AML and HR-MDS,” said Taylor Schreiber, M.D., Ph.D., and Chief
Executive Officer of Shattuck. “This year we have significantly
expanded our clinical trial footprint to enable steady execution of
our clinical studies and are looking forward to the opportunity for
SL-172154 to differentiate from other CD47 inhibitors over the
course of a data-rich 2023. Beyond our clinical-stage product
candidates, we have progressed our gamma delta T cell engager
(GADLEN) platform and published key preclinical data which will
guide our clinical strategy. We expect to provide additional
updates later this month at the SITC annual meeting.”
Third Quarter 2022 Recent Business Highlights and Other
Recent Developments
ARC Clinical-Stage Pipeline and Preclinical
Pipeline
SL-172154 (SIRPα-Fc-CD40L) Program Update
- Completed Enrollment and Study
Objectives in Phase 1 Monotherapy Dose-Escalation Clinical Trial of
SL-172154 in Platinum-Resistant Ovarian Cancer: 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 advanced platinum-resistant ovarian cancer. We
reached a maximum administered dose of 10.0 mg/kg and completed
enrollment of additional patients at 3.0 mg/kg with an extended
infusion time. We expect to present complete dose-escalation data
from the trial midyear 2023.
- First Patient Dosed in
Combination Trial of SL-172154 with Liposomal Doxorubicin in
Advanced Platinum-Resistant Ovarian Cancer: Enrollment is
continuing in this trial, which is evaluating the safety,
tolerability, pharmacokinetics, anti-tumor activity, and
pharmacodynamic effects of SL-172154, starting at 3.0 mg/kg, in
combination with liposomal doxorubicin in patients with advanced
platinum-resistant ovarian cancer. We expect to present initial
data from the trial midyear 2023.
- Enrollment Progressing in Phase
1A/B Clinical Trial of in SL-172154 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 with
azacitidine in a parallel staggered dose escalation. Patients have
been dosed in the initial monotherapy cohorts of this trial and
enrollment in the azacitidine combination cohorts is expected to
begin in the fourth quarter of 2022. Initial dose-escalation data
from both monotherapy and azacitidine combination cohorts are
expected in the first half of 2023.
SL-279252 (PD1-Fc-OX40L)
- Continued Enrollment of
SL-279252 Phase 1 Dose-Escalation Clinical Trial in Advanced Solid
Tumors: Enrollment of patients with primarily PD-L1
selected tumors continues in the Phase 1 open-label, multi-center,
dose-escalation clinical trial to evaluate the safety,
tolerability, pharmacokinetics, anti-tumor activity and
pharmacodynamic effects of SL-279252 in patients with advanced
solid tumors and lymphoma. Top-line data from the Phase 1 trial are
anticipated in the first quarter of 2023.
GADLEN
- Preclinical Candidates from
GADLEN Platform Continue to Advance: We have developed
both CD20-directed and B7H3-directed GADLEN product candidates.
Additional preclinical data on both programs will be presented at
the annual SITC conference in November. We plan to provide
additional clinical development detail and further program guidance
in 2023.
Upcoming Events
- 37th
Annual SITC Annual Meeting: Updated preclinical
data on Gamma Delta T Cell Engager (GADLEN) platform candidates to
be presented at Society for Immunotherapy of Cancer (SITC) Annual
Meeting taking place in Boston on November 8-12, 2022.
- Cowen’s 6th Annual IO Next
Summit: Management will participate in a fireside chat
with covering analyst Marc Frahm at Cowen’s Annual IO Next
Conference taking place virtually on November 11, 2022.
- 5th
Annual Evercore ISI HealthCONx Conference:
Management will participate in investor one-on-one meetings and a
fireside chat with covering analyst Jonathan Miller at the Evercore
ISI HealthCONx Conference taking place virtually on November 30 -
December 1, 2022.
- 34th Annual Piper Sandler
Healthcare Conference: Management will participate in
investor one-on-one meetings and present a corporate update at the
Annual Piper Sandler Healthcare Conference taking place in New York
City on November 29 - December 1, 2022.
- Live and archived audio webcasts of the
fireside chats and presentation will be available on the Events
& Presentations section of the Company’s website.
Third Quarter 2022 Financial Results
- Cash Position: As of
September 30, 2022, cash and cash equivalents and investments were
$185.1 million, as compared to $268.8 million as of December 31,
2021.
- Research and Development
(R&D) Expenses: R&D expenses for the quarter ended
September 30, 2022 were $18.9 million, as compared to $15.1 million
for the quarter ended September 30, 2021. This increase was
primarily driven by increases in clinical costs, including clinical
site and contract research organization costs, to support clinical
development of SL-172154, lab supplies, and personnel-related
costs.
- General and Administrative
(G&A) Expenses: G&A expenses for the quarter ended
September 30, 2022 were $6.6 million, as compared to $4.3 million
for the quarter ended September 30, 2021. This increase was
primarily driven by a litigation settlement of $1.4 million and
increases in personnel-related and other operating costs.
- Net Loss: Net loss was
$24.6 million for the quarter ended September 30, 2022, or $0.58
per basic and diluted share, as compared to a net loss of $17.4
million for the quarter ended September 30, 2021, or $0.41 per
basic and diluted share.
2022 Financial Guidance
Shattuck believes its cash and cash equivalents and investments
will be sufficient to fund its operations into the second half of
2024, beyond results from its Phase 1 clinical trials of SL-172154
and SL-279252. This cash runway guidance is based on the Company’s
current operational plans and excludes any addition funding that
may be received, proceeds from business development transactions,
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. Phase 1 clinical trials are ongoing for patients with
advanced platinum-resistant ovarian cancer (NCT05483933) and
patients with AML and HR-MDS (NCT05275439).
About SL-279252
SL-279252 (PD1-Fc-OX40L) is an investigational ARC® fusion
protein designed to simultaneously inhibit the PD-1/PD-L1
interaction and activate the OX40 receptor in patients with
advanced cancers. A Phase 1 trial in patients with solid tumors and
lymphoma is ongoing (NCT03894618).
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 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. A
second product candidate, SL-279252 (PD1-Fc-OX40L), is being
evaluated in a Phase 1 trial in solid tumors or lymphomas.
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 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, the anticipated timing for
enrollment of our clinical trials, 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: the recent and ongoing COVID-19
pandemic; 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, 2021, 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
RichardsonSenior Director, Finance & Investor RelationsShattuck
Labs, Inc.InvestorRelations@shattucklabs.com
PART I - FINANCIAL
INFORMATION
Item 1. Financial Statements
SHATTUCK LABS, INC.
BALANCE SHEETS
(In thousands)
|
September 30, 2022 |
December 31,2021 |
|
(unaudited) |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
39,758 |
|
$ |
92,268 |
|
Investments |
|
145,356 |
|
|
176,536 |
|
Prepaid expenses and other current assets |
|
16,402 |
|
|
19,462 |
|
Total current assets |
|
201,516 |
|
|
288,266 |
|
Property and equipment,
net |
|
18,242 |
|
|
9,938 |
|
Other assets |
|
3,185 |
|
|
381 |
|
Total assets |
$ |
222,943 |
|
$ |
298,585 |
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$ |
3,036 |
|
$ |
10,012 |
|
Accrued expenses and other current liabilities |
|
16,103 |
|
|
14,574 |
|
Total current liabilities |
|
19,139 |
|
|
24,586 |
|
Non-current operating lease
liabilities |
|
4,386 |
|
|
— |
|
Deferred rent |
|
— |
|
|
2,213 |
|
Total liabilities |
|
23,525 |
|
|
26,799 |
|
Stockholders’ equity: |
|
|
Common stock |
|
5 |
|
|
5 |
|
Additional paid-in capital |
|
394,348 |
|
|
389,408 |
|
Accumulated other comprehensive loss |
|
(1,334 |
) |
|
(560 |
) |
Accumulated deficit |
|
(193,601 |
) |
|
(117,067 |
) |
Total stockholders’ equity |
|
199,418 |
|
|
271,786 |
|
Total liabilities and stockholders’ equity |
$ |
222,943 |
|
$ |
298,585 |
|
SHATTUCK LABS, INC.
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, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Collaboration revenue |
$ |
212 |
|
|
$ |
1,900 |
|
|
$ |
262 |
|
|
$ |
(61 |
) |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
18,862 |
|
|
|
15,137 |
|
|
|
61,012 |
|
|
|
40,356 |
|
General and administrative |
|
6,579 |
|
|
|
4,343 |
|
|
|
16,303 |
|
|
|
14,098 |
|
Expense from operations |
|
25,441 |
|
|
|
19,480 |
|
|
|
77,315 |
|
|
|
54,454 |
|
Loss from operations |
|
(25,229 |
) |
|
|
(17,580 |
) |
|
|
(77,053 |
) |
|
|
(54,515 |
) |
|
|
|
|
|
|
|
|
Other income |
|
594 |
|
|
|
170 |
|
|
|
519 |
|
|
|
1,694 |
|
Net loss |
$ |
(24,635 |
) |
|
$ |
(17,410 |
) |
|
$ |
(76,534 |
) |
|
$ |
(52,821 |
) |
Unrealized loss on
investments |
|
(226 |
) |
|
|
(207 |
) |
|
|
(774 |
) |
|
|
(1,764 |
) |
Comprehensive loss |
$ |
(24,861 |
) |
|
$ |
(17,617 |
) |
|
$ |
(77,308 |
) |
|
$ |
(54,585 |
) |
|
|
|
|
|
|
|
|
Net loss per share – basic and
diluted |
$ |
(0.58 |
) |
|
$ |
(0.41 |
) |
|
$ |
(1.81 |
) |
|
$ |
(1.26 |
) |
Weighted-average shares
outstanding – basic and diluted |
|
42,386,470 |
|
|
|
42,155,981 |
|
|
|
42,374,955 |
|
|
|
41,946,852 |
|
Shattuck Labs (NASDAQ:STTK)
Historical Stock Chart
From Jun 2024 to Jul 2024
Shattuck Labs (NASDAQ:STTK)
Historical Stock Chart
From Jul 2023 to Jul 2024