ADC Therapeutics SA (NYSE: ADCT) today provided business updates.
“During 2023, we took a number of decisive
actions to help position the Company for success in 2024 and
beyond. We prioritized our pipeline, strengthened our organization
and implemented a disciplined capital allocation model to generate
cost efficiencies,” said Ameet Mallik, Chief Executive Officer of
ADC Therapeutics. “We believe we are starting to see signs of the
commercial turnaround. We are also encouraged to see positive
initial signals in the LOTIS-7 trial of ZYNLONTA in combination
with bispecifics as well as early signs of antitumor activity in
the Phase 1b trial of ADCT-601. We now expect our cash runway to
extend into the fourth quarter of 2025 and believe we are on a path
to unlock the substantial value in the Company.”
Recent Highlights and
Developments
ZYNLONTA®
(loncastuximab tesirine-lpyl)
- ZYNLONTA net sales for the fourth
quarter of 2023 are expected to be approximately $16.5
million.
- The Phase 1 LOTIS-7 trial of
ZYNLONTA in combination with bispecifics glofitamab or
mosunetuzumab for the treatment of patients with diffuse large
B-cell lymphoma (DLBCL), follicular lymphoma (FL) and marginal zone
lymphoma (MZL) is actively enrolling patients. The dose-limiting
toxicity (DLT) period has been cleared for the first dosing level
of ZYNLONTA 90 µg/kg in both arms, and there have been no
discontinuations due to adverse events (AEs). To date, each of the
first five patients eligible for assessment in this dosing level
has shown a response (partial response or complete response) at
first scan.
- An oral presentation at the
American Society of Hematology (ASH) 2023 Annual Meeting from the
University of Miami investigator-initiated trial exploring ZYNLONTA
in combination with rituximab in high-risk relapsed or refractory
FL indicated a best overall response rate of 96.3% and a complete
response rate of 85.2%. After a median follow-up of 9.7 months,
the median progression-free survival (PFS) was not reached, and the
12-month PFS was 92.3%. The majority of AEs were grade 1. Grade 3
AEs included neutropenia (n=2; 6.2%), and one case each (3.1%) of
hyperglycemia, increased ALT, fatigue, dyspnea and skin infection.
Neutropenia was the only grade 4 AE (n=1; 3.1%).
Pipeline
- ADCT-601 (targeting
AXL): In the Phase 1b trial, the maximum-tolerated dose
has been reached, and the study is currently in dose optimization.
There have been early signs of antitumor activity in both
monotherapy and in combination. The dose-optimization/ expansion
phase is comprised of a monotherapy arm including patients with
sarcoma, pancreatic cancer and AXL-expressing non-small cell lung
cancer (NSCLC) and a combination arm with gemcitabine in patients
with sarcoma and pancreatic cancer.
- ADCT-901 (targeting
KAAG1): The Company has decided to discontinue this
program due to limited signs of efficacy in the dose escalation
phase and to reallocate capital to prioritized programs.
- ADCT-602 (targeting
CD22): Dose escalation and expansion in the Phase 1 trial
in collaboration with MD Anderson Cancer Center for patients with
relapsed or refractory acute lymphoblastic leukemia is progressing,
and additional clinical trial sites are being added to accelerate
enrollment.
- Early-stage
pipeline: The Company is advancing a portfolio of
investigational ADCs including those targeting Claudin-6, NaPi2b
and PSMA. These candidates utilize exatecan with a novel
hydrophilic linker as a highly potent and differentiated
payload.
Balance SheetThe Company ended
the fourth quarter of 2023 with cash and cash equivalents of
~$278.5 million.
GuidanceThe Company expects the
following based on its current business plan:
- Decrease in total operating
expenses expected in full year 2023 and 2024 as compared to
2022
- Cash runway expected into 4Q
20252 (previously: mid-2025)
Expected Milestones in 2024
ZYNLONTA
- Achieve commercial brand
profitability in 2024
- LOTIS-5: Complete enrollment in
2024
- LOTIS-7: Additional safety and
efficacy data from the dose-escalation and dose-expansion portions
of the Phase 1 study in 2024
Pipeline
ADCT-601 (targeting AXL)
- Additional data updates from the
Phase 1 study in patients with sarcoma, pancreatic cancer and NSCLC
in 2024
ADCT-602 (targeting CD22)
- Additional data from Phase 1 study
in 2024
Please refer to the Company’s Form 8-K and
accompanying presentation filed with the Securities and Exchange
Commission today for additional information.
About ZYNLONTA® (loncastuximab
tesirine-lpyl)
ZYNLONTA® is a CD19-directed antibody drug
conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is
internalized by the cell, where enzymes release a
pyrrolobenzodiazepine (PBD) payload. The potent payload binds to
DNA minor groove with little distortion, remaining less visible to
DNA repair mechanisms. This ultimately results in cell cycle arrest
and tumor cell death.
The U.S. Food and Drug Administration (FDA) and
the European Medicines Agency (EMA) have approved ZYNLONTA
(loncastuximab tesirine-lpyl) for the treatment of adult patients
with relapsed or refractory (r/r) large B-cell lymphoma after two
or more lines of systemic therapy, including diffuse large B-cell
lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from
low-grade lymphoma and also high-grade B-cell lymphoma. The trial
included a broad spectrum of heavily pre-treated patients (median
three prior lines of therapy) with difficult-to-treat disease,
including patients who did not respond to first-line therapy,
patients refractory to all prior lines of therapy, patients with
double/triple hit genetics and patients who had stem cell
transplant and CAR-T therapy prior to their treatment with
ZYNLONTA. This indication is approved by the FDA under accelerated
approval and in the European Union under conditional approval based
on overall response rate and continued approval for this indication
may be contingent upon verification and description of clinical
benefit in a confirmatory trial. Please see full prescribing
information including important safety information about ZYNLONTA
at www.ZYNLONTA.com.
ZYNLONTA is also being evaluated as a
therapeutic option in combination studies in other B-cell
malignancies and earlier lines of therapy.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a
commercial-stage global leader and pioneer in the field of antibody
drug conjugates (ADCs). The Company is advancing its proprietary
ADC technology to transform the treatment paradigm for patients
with hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-directed ADC ZYNLONTA
(loncastuximab tesirine-lpyl) received accelerated approval by the
FDA and conditional approval from the European Commission for the
treatment of relapsed or refractory diffuse large B-cell lymphoma
after two or more lines of systemic therapy. ZYNLONTA is also in
development in combination with other agents and in earlier lines
of therapy. In addition to ZYNLONTA, ADC Therapeutics has multiple
ADCs in ongoing clinical and preclinical development.
ADC Therapeutics is based in Lausanne (Biopôle),
Switzerland and has operations in London, the San Francisco Bay
Area and New Jersey. For more information, please visit
https://adctherapeutics.com/ and follow the Company on
LinkedIn.
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. In some cases you
can identify forward-looking statements by terminology such as
“may”, “assumes”, “will”, “should”, “would”, “expect”, “intend”,
“plan”, “anticipate”, “believe”, “estimate”, “predict”,
“potential”, “seem”, “seek”, “future”, “continue”, or “appear” or
the negative of these terms or similar expressions, although not
all forward-looking statements contain these identifying words.
Forward-looking statements are subject to certain risks and
uncertainties that can cause actual results to differ materially
from those described. Factors that may cause such differences
include, but are not limited to: the actual Zynlonta revenue for 4Q
2023, the success of the Company’s updated corporate strategy
including operating efficiencies, capital deployment and portfolio
prioritization; the Company’s ability to achieve the decrease in
total operating expenses for 2023 and 2024, the expected cash
runway into 4Q 2025, the effectiveness of the new commercial
go-to-market strategy, competition from new technologies, and the
Company’s ability to grow ZYNLONTA® revenue in the United States;
Swedish Orphan Biovitrum AB (Sobi®) ability to successfully
commercialize ZYNLONTA® in the European Economic Area and market
acceptance, adequate reimbursement coverage, and future revenue
from the same; approval by the NMPA of the BLA for ZYNLONTA® in
China submitted by Overland ADCT BioPharma and future revenue from
the same, our strategic partners’, including Mitsubishi Tanabe
Pharma Corporation, ability to obtain regulatory approval for
ZYNLONTA® in foreign jurisdictions, and the timing and amount of
future revenue and payments to us from such partnerships; the
impact, if any, from data reported by the University of Miami for
their IIT in FL; the timing and results of the Company’s or its
partners’ clinical trials including LOTIS 5 and 7, ADCT 601 and 602
as well as the Company’s early-stage pipeline research projects,
actions by the FDA or foreign regulatory authorities with respect
to the Company’s products or product candidates; projected revenue
and expenses; the Company’s indebtedness, including Healthcare
Royalty Management and Oaktree and Blue Owl facilities, and the
restrictions imposed on the Company’s activities by such
indebtedness, the ability to repay such indebtedness and the
significant cash required to service such indebtedness; and the
Company’s ability to obtain financial and other resources for its
research, development, clinical, and commercial activities.
Additional information concerning these and other factors that may
cause actual results to differ materially from those anticipated in
the forward-looking statements is contained in the “Risk Factors”
section of the Company's Annual Report on Form 20-F and in the
Company's other periodic reports and filings with the Securities
and Exchange Commission. These statements involve known and unknown
risks, uncertainties and other factors that may cause actual
results, performance, achievements or prospects to be materially
different from any future results, performance, achievements or
prospects expressed in or implied by such forward-looking
statements. The Company cautions investors not to place undue
reliance on the forward-looking statements contained in this
document. The Company undertakes no obligation to revise or update
these forward-looking statements to reflect events or circumstances
after the date of this press release, except as required by
law.
CONTACTS:
InvestorsEugenia LitzADC
TherapeuticsEugenia.Litz@adctherapeutics.com+44 7879 627205+1
908-723-2350
MediaNicole RileyADC
TherapeuticsNicole.Riley@adctherapeutics.com+1 862-926-9040
(1) loncastuximab tesirine-lpyl; DLT: Dose-Limiting Toxicity;
MTD: Maximum-Tolerated Dose
(2) Cash runway assumes receipt of anticipated regulatory
milestone payments under the Company’s collaboration agreements and
use of the amount it is required to maintain under its loan
agreement
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