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, 2022 and
provided recent business highlights.
“We have made significant progress throughout the second
quarter, including dosing patients in our Phase 1 clinical trial of
SL-172154 in AML and HR-MDS and advancing SL-172154 in our clinical
trial in platinum-resistant ovarian cancer,” said Taylor Schreiber,
M.D., Ph.D., and Chief Executive Officer of Shattuck. “As we look
ahead to the second half of this year, we look forward to beginning
to enroll patients at immunologically active dose levels of
SL-172154 in combination with liposomal doxorubicin for patients
with advanced platinum-resistant ovarian cancer and with
azacitidine for patients with AML and HR-MDS. We also continue to
make excellent progress advancing our preclinical pipeline from our
ARC and GADLEN platforms, and we expect to nominate the next
clinical product candidate by the end of this year.”
Second Quarter 2022 Recent Business Highlights and Other
Recent Developments
ARC Clinical-Stage Pipeline and Preclinical
Pipeline
SL-172154 (SIRPα-Fc-CD40L)
- Continued Enrollment of SL-172154 Phase 1 Monotherapy
Dose-Escalation Clinical Trial in Platinum-Resistant Ovarian
Cancer: This open-label, multi-center, dose-escalation
clinical trial is evaluating the safety, tolerability,
pharmacokinetics, anti-tumor activity, and pharmacodynamic effects
of SL-172154 administered intravenously in patients with advanced
platinum-resistant ovarian cancer. To date, Shattuck has dose
escalated to the anticipated top dose level of 10.0 mg/kg. Most
patients at both the 3.0 mg/kg and 10.0 mg/kg dose levels have
experienced grade 2 infusion related reactions, which did not lead
to any treatment discontinuations. In one of five patients treated
at the 10.0 mg/kg dose level, we observed a dose limiting toxicity
of alanine transaminase increase. Preliminary data suggest that
extending the duration of infusion may reduce the incidence of
infusion related reactions. We are currently enrolling additional
patients at 3.0 mg/kg with an extended infusion time. To date, we
have observed no evidence of destructive anemia in any patient
treated. We have observed full receptor occupancy and receptor
saturation of CD40 and CD47 at the 3.0 mg/kg dose level and data
indicate that both serum cytokine elevations and margination of
CD40+ B cells and monocytes have achieved a maximal plateau at
doses of 3.0 mg/kg and 10.0 mg/kg. Dose-escalation data from the
trial are expected in the first half of 2023.
- Combination Trial of SL-172154 with Liposomal
Doxorubicin Expected to Begin in the Third Quarter of
2022: This trial will evaluate the safety, tolerability,
pharmacokinetics, anti-tumor activity, and pharmacodynamics effects
of SL-172154 in combination with liposomal doxorubicin in patients
with advanced platinum-resistant ovarian cancer and is anticipated
to begin enrollment in the third quarter of 2022. Our starting dose
of SL-172154 in this trial is 3.0 mg/kg. Initial combination data
from the trial are expected in the first half of 2023.
- Enrollment Continues in SL-172154 Phase 1A/B Clinical
Trial in AML and HR-MDS: The trial is evaluating the
safety, tolerability, pharmacokinetics, anti-tumor activity, and
pharmacodynamic effects of SL-172154 as both monotherapy and in
combination. Our starting dose of SL-172154 in the monotherapy
portion of this clinical trial is 1.0 mg/kg. In AML, SL-172154 will
be evaluated in combination with both azacitidine and venetoclax.
In both HR-MDS and TP53 mutant AML, SL-172154 will be combined with
azacitidine. We plan to dose escalate as both monotherapy and in
combination in a parallel staggered manner. Initial dose-escalation
and combination data from the trial are expected in the first half
of 2023.
- Provided Clinical Data for Intratumorally Administered
SL-172154 in Phase 1 Clinical Trial in Squamous Cell Carcinoma of
the Head and Neck (HNSCC) or Skin (CSCC): As of the data
cut-off date of April 8, 2022, five patients with cancer, four with
CSCC and one with HNSCC, were treated with intratumoral
administration of SL-172154 across two dose levels, 0.003 and 0.01
mg. All patients had prior anticancer surgery, four out of five
patients had prior radiotherapy, and all patients had prior
systemic therapy, with a median of two prior lines. SL-172154 was
well tolerated at the two dose levels studied with no dose-limiting
toxicities reported, and no significant safety signals were noted.
An unconfirmed partial response was observed in a patient with CSCC
who experienced a 75 percent reduction in the target lesion, and
stable disease was observed in an additional CSCC patient.
Increases in CD80, a marker of CD40 activation, have been observed
in on-treatment tumor biopsies. Based on the totality of the safety
and biomarker data collected to date in the ongoing Phase 1
clinical trial in ovarian cancer patients, Shattuck has decided to
focus on developing SL-172154 as an intravenously administered
product candidate.
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 second
half of 2022.
Preclinical
- Presented Preclinical Development of Gamma Delta T Cell
Engager, or GADLEN, platform at the 3rd Gamma Delta T Therapies
Summit in July 2022: Data were presented demonstrating
preclinical proof of concept for Shattuck’s butyrophilin
heterodimer-based gamma delta T cell engager platform. Data from
CD19, CD20, and B7-H3-targeted GADLEN constructs demonstrated the
newly described role of co-stimulation during Vg9d2 T cell
activation and tumor cell killing. In vivo proof-of-concept data
was also presented establishing the ability of the CD20-GADLEN to
activate human Vg9d2 T cells to target and serially deplete
CD20-expressing human B-cells in a dose-dependent, and highly
specific, manner.
- Presented Preclinical Development of SL-9258 at the
PEGS Conference in May of 2022 and Published the Associated
Preclinical Manuscript in the Journal of Immunology in July
2022: SL-9258 (TIGIT-Fc-LIGHT), a dual TIGIT inhibitor and
HVEM/LTβR agonist, was shown to induce potent anti-tumor immunity
in preclinical mouse models of checkpoint primary and acquired
resistance, both alone and when combined with anti-PD1 or
anti-PDL1, through the simultaneous blockade of the TIGIT
checkpoint pathway and broad immune activation of T, NK, and
myeloid cells through the TNF-costimulatory ligand known as
LIGHT.
- Clinical Pipeline Product Candidate to be Selected in
2022: As Shattuck looks to advance its preclinical
pipeline, a new clinical product candidate from our ARC or GADLEN
platform is anticipated to be announced in the second half of
2022.
Upcoming Events
- Citi’s 17th Annual BioPharma Conference:
Management will participate in investor one-on-one meetings and a
fireside chat at Citi’s 17th Annual BioPharma Conference from
September 7-8, 2022.
- H.C. Wainwright 24th Annual Global Investment
Conference: Management will participate in investor
one-on-one meetings and give a corporate presentation during the
H.C. Wainwright 24th Annual Global Investment Conference from
September 12-14, 2022.
- Live and archived audio webcasts of both the fireside chat and
presentation will be available by visiting the Events &
Presentations section of the Company’s website.
Second Quarter 2022 Financial Results
- Cash Position: As of June 30, 2022, cash and
cash equivalents and short-term investments were $214.2 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 June 30, 2022 were $23.0
million, as compared to $14.9 million for the quarter ended June
30, 2021. This increase was primarily driven by increases in
process development costs and manufacturing of trial materials 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 June 30, 2022 were $4.8
million, as compared to $5.4 million for the quarter ended June 30,
2021. This decrease was primarily driven by decreases in
personnel-related and other operating costs.
- Net Loss: Net loss was $27.4 million for the
quarter ended June 30, 2022, or $0.65 per basic and diluted share,
as compared to a net loss of $23.6 million for the quarter ended
June 30, 2021, or $0.56 per basic and diluted share.
2022 Financial GuidanceShattuck believes its
cash and cash equivalents and short-term 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-172154SL-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 advanced platinum-resistant ovarian
cancer (NCT04406623, NCT05483933) and patients with AML and HR-MDS
(NCT05275439).
About SL-279252SL-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 StatementsCertain 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)
|
June 30, 2022 |
December 31,2021 |
|
(unaudited) |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
37,870 |
|
$ |
92,268 |
|
Investments |
|
176,370 |
|
|
176,536 |
|
Prepaid expenses and other current assets |
|
15,177 |
|
|
19,462 |
|
Total current assets |
|
229,417 |
|
|
288,266 |
|
Property and equipment,
net |
|
18,759 |
|
|
9,938 |
|
Other assets |
|
3,164 |
|
|
381 |
|
Total assets |
$ |
251,340 |
|
$ |
298,585 |
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$ |
5,674 |
|
$ |
10,012 |
|
Accrued expenses and other current liabilities |
|
18,571 |
|
|
14,574 |
|
Total current liabilities |
|
24,245 |
|
|
24,586 |
|
Non-current operating lease
liabilities |
|
4,566 |
|
|
— |
|
Deferred rent |
|
— |
|
|
2,213 |
|
Total liabilities |
|
28,811 |
|
|
26,799 |
|
Stockholders’ equity: |
|
|
Common stock |
|
5 |
|
|
5 |
|
Additional paid-in capital |
|
392,598 |
|
|
389,408 |
|
Accumulated other comprehensive loss |
|
(1,108 |
) |
|
(560 |
) |
Accumulated deficit |
|
(168,966 |
) |
|
(117,067 |
) |
Total stockholders’ equity |
|
222,529 |
|
|
271,786 |
|
Total liabilities and stockholders’ equity |
$ |
251,340 |
|
$ |
298,585 |
|
SHATTUCK LABS, INC.
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, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Collaboration revenue |
$ |
50 |
|
|
$ |
(4,231 |
) |
|
$ |
50 |
|
|
$ |
(1,961 |
) |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
22,963 |
|
|
|
14,882 |
|
|
|
42,150 |
|
|
|
25,219 |
|
General and administrative |
|
4,745 |
|
|
|
5,399 |
|
|
|
9,724 |
|
|
|
9,755 |
|
Expense from operations |
|
27,708 |
|
|
|
20,281 |
|
|
|
51,874 |
|
|
|
34,974 |
|
Loss from operations |
|
(27,658 |
) |
|
|
(24,512 |
) |
|
|
(51,824 |
) |
|
|
(36,935 |
) |
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
Other |
|
287 |
|
|
|
914 |
|
|
|
(75 |
) |
|
|
1,524 |
|
Net loss |
$ |
(27,371 |
) |
|
$ |
(23,598 |
) |
|
$ |
(51,899 |
) |
|
$ |
(35,411 |
) |
Unrealized loss on
investments |
|
(581 |
) |
|
|
(960 |
) |
|
|
(548 |
) |
|
|
(1,557 |
) |
Comprehensive loss |
$ |
(27,952 |
) |
|
$ |
(24,558 |
) |
|
$ |
(52,447 |
) |
|
$ |
(36,968 |
) |
|
|
|
|
|
|
|
|
Net loss per share – basic and
diluted |
$ |
(0.65 |
) |
|
$ |
(0.56 |
) |
|
$ |
(1.22 |
) |
|
$ |
(0.85 |
) |
Weighted-average shares
outstanding – basic and diluted |
|
42,380,454 |
|
|
|
41,906,268 |
|
|
|
42,369,102 |
|
|
|
41,840,555 |
|
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