false
0001771910
0001771910
2026-10-07
2026-10-07
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported):
October 7, 2026
ADC Therapeutics
SA
(Exact Name of Registrant as Specified in Its Charter)
| Switzerland |
001-39071 |
N/A |
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
Biopôle
Route de la Corniche 3B
1066 Epalinges
Switzerland
(Address of Principal Executive Offices) (Zip Code) |
+41 21 653 02 00
(Registrant’s Telephone Number) |
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.
below):
| ☐ | Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Exchange Act:
| Title of Each Class |
Trading Symbol |
Name of Each Exchange on Which Registered |
| Common Shares, par value CHF 0.08 per share |
ADCT |
New York Stock Exchange |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (17 C.F.R. § 230.405) or Rule 12b-2 of the Securities Exchange Act of
1934 (17 C.F.R. § 240.12b-2). Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ☐
Item 1.01. Entry into a Material Definitive Agreement.
Private Placement
On October 7, 2026, ADC Therapeutics SA (the
“Company”) entered into securities purchase agreements for the sale of its equity securities to certain institutional
investors in a $86.6 million (assuming the cash exercise of the pre-funded warrants) private placement (the “Private
Placement”). In the private placement, the Company will sell 12,911,347 common shares at $1.4200 per share and pre-funded
warrants to purchase 48,088,653 common shares at $1.32400 per pre-funded warrant, which is the price per common share in the private
placement minus the exercise price per pre-funded warrant. The private placement is expected to close on October 22, 2026, subject
to customary closing conditions.
The purchase agreements provide certain registration rights, pursuant
to which the Company has agreed to file a registration statement within 30 business days to register the resale of the common shares sold
in the private placement and the common shares issuable upon exercise of the pre-funded warrants sold in the private placement.
The private placement is exempt from the registration requirements
of the Securities Act of 1933, as amended (the “Securities Act”) under Section 4(a)(2) of the Securities Act in that the private
placement is between an issuer and sophisticated investors not involving any public offering. The Company is relying on this exemption
from registration based in part on representations made in the purchase agreements for the private placement, a form of which is attached
to this Current Report on Form 8-K as Exhibit 10.1.
The pre-funded warrants are exercisable at any time after their original
issuance until the tenth anniversary of their original issuance. At any time during the last 90 days of the term, the holder may exchange
the pre-funded warrant for, and the Company will issue, a new pre-funded warrant for the number of common shares then remaining under
the pre-funded warrant. The pre-funded warrants will be exercisable, at the option of each holder, in whole or in part (but not for less
than a common share) by delivering to the Company a duly executed exercise notice and by payment of the aggregate exercise price; provided
that any exercise of the pre-funded warrants must be for at least 50,000 common shares (or, if less, the remaining common shares available
for purchase under the pre-funded warrants). A holder will not be entitled to exercise any portion of any pre-funded warrants that, upon
giving effect to such exercise, would cause the aggregate number of the Company’s common shares beneficially owned by the holder
(together with its affiliates and certain attribution parties) to exceed 9.99% (or, 61 days after a written notice from such holder, any
other percentage not in excess of 19.99%) of the number of the Company’s common shares outstanding immediately after giving effect
to the exercise, as such percentage ownership is determined in accordance with the terms of the pre-funded warrants. The exercise price
per common share purchasable upon the exercise of the pre-funded warrants is CHF 0.08 per share, subject to customary adjustments. In
lieu of making cash payment of the aggregate exercise price, a holder may elect to exercise the pre-funded warrants on a cashless basis.
However, if the Company, at the time of receipt of an exercise notice electing cashless exercise, (i) does not, or has reason to believe
that the Company does not, have a sufficient amount of freely distributable equity to fund the nominal value of the number of common shares
the Company would be required to deliver upon such cashless exercise, and (ii) (x) holds common shares representing more than 2% of its
share capital registered in the commercial register at that time (the “Minimum Stock”) in treasury, then the Company will
not be obligated to (but may) deliver more than such number of common shares to the holder as exceeds the Minimum Stock or (y) holds up
to the Minimum Stock in treasury, then the Company will not be obligated to deliver any common shares to the holder. The exercise notice
will be deemed to be null and void to the extent the holder receives fewer common shares than to which such exercise notice relates. In
the event of (i) a sale, lease or other transfer of all or substantially all of the Company’s assets, (ii) a merger or consolidation
involving the Company in which the Company is not the surviving entity or in which the Company’s outstanding share capital is converted
into or exchanged for shares of capital stock or other securities or property of another entity, or (iii) any sale by holders of the Company’s
outstanding voting equity securities in a single transaction or series of related transactions of shares constituting a majority of the
Company’s outstanding combined voting power, and (x) if the consideration received by the Company’s shareholders consists
solely of cash and/or marketable securities, then holders of the pre-funded warrants will be deemed to have exercised their pre-funded
warrants (without regard to the exercise limitations described above) immediately prior to the closing date of such transaction or (y)
if the consideration received by the Company’s shareholders does not consist solely of cash and/or marketable securities, then the
Company will cause the successor or surviving entity to assume the pre-funded warrants. Subject to applicable laws, the pre-funded warrants
may be offered for sale, sold, transferred or assigned without the Company’s consent. The pre-funded warrants are governed by the
laws of Switzerland. The foregoing description of the pre-funded warrants does not purport to be complete and is qualified in its entirety
by reference to the form of pre-funded warrant, which is attached to this Current Report on Form 8-K as Exhibit 10.2.
Amendment to Loan Agreement
On October 7, 2026, the Company, certain subsidiaries of the
Company, the lenders party thereto and Blue Owl Opportunistic Lending Master Fund I, L.P., as administrative agent and collateral
agent, entered into a second amendment (the “Loan Agreement Amendment”) to the Loan Agreement and Guaranty, dated August
15, 2022 (as amended from time to time, the “Loan Agreement”). The effectiveness of the Loan Agreement Amendment
is conditioned on, among other things, the prepayment of $70.0 million principal amount of term loans under the Loan Agreement, plus accrued and unpaid
interest with respect thereto and any related fees and premiums, inclusive of the Company’s scheduled September 30, 2026
amortization payment. Immediately after such prepayment, if made, the principal amount of outstanding term loans under the Loan
Agreement will be $50.0 million. Upon effectiveness, the Loan Agreement Amendment eliminates subsequent scheduled principal
amortization, with the remaining principal payable at maturity unless earlier accelerated; eliminates the minimum liquidity
covenant; and sets the minimum trailing four-quarter U.S. ZYNLONTA sales covenant at $65.0 million for the quarter ending December
31, 2026 and each quarter thereafter. The foregoing description of the
Loan Agreement Amendment does not purport to be complete and is qualified in its entirety by reference to the Loan Agreement
Amendment, which is attached to this Current Report on Form 8-K as Exhibit 10.3.
In connection with the Loan Agreement Amendment, the Company
entered into amendments to the warrants to purchase an aggregate of 527,295 common shares, which were issued on August 15, 2022 in
connection with the Loan Agreement (the “Lender Warrants”). The amendments reduce the exercise price of the Lender
Warrants from $8.30 per share to $1.00 per share (being the lesser of $1.00 per share and the price per common share in the Private
Placement). The effectiveness of the amendments to the Lender Warrants is conditioned upon the effectiveness of the Loan Agreement
Amendment. The foregoing description of the amendments to the Lender Warrants does not purport to be complete and is qualified in
its entirety by reference to the form of amendment to the Lender Warrants, which is attached to this Current Report on Form 8-K as
Exhibit 10.4.
Amendment to Royalty Purchase and Sale Agreement
On October 7, 2026, the Company entered into Amendment
No. 2 (the “HCR Amendment”) to its Purchase and Sale Agreement, dated August 25, 2021(as amended from time to time, the
“HCR Agreement”), with certain entities managed by Healthcare Royalty Management, LLC (collectively, “HCR”).
To date, HCR has provided $300 million of funding to the Company. The HCR Amendment eliminates the payment otherwise required solely
upon a change of control and permits the Company (or its successor in interest) to exercise its option to buy out the remaining
royalty obligations without a change of control by paying HCR $525 million (if the buyout occurs on or prior to December 31, 2029)
or $750 million (if the buyout occurs on or after January 1, 2030), less the amount of royalties previously paid to HCR. If this
option is not exercised, the royalty obligations under the HCR Agreement will continue until the Royalty Cap (as defined in the HCR
Agreement). In addition, the HCR Amendment reduces the aggregate outstanding principal amount of third-party indebtedness of the
Company and its subsidiaries are permitted to incur to $50.0 million. An uncured breach of this debt limitation covenant entitles
HCR to elect to receive the non-performance payment equaling 1.5 times the difference between the $300 million aggregate purchase
price and royalty payments and other qualifying credited amounts actually received by HCR, subject to a cure period. The HCR
Amendment also requires the Company, subject to shareholder approval and applicable legal and fiduciary duties limitations, to use
its best efforts to become a Delaware corporation. In addition, the HCR Amendment amends the warrants to purchase 9,834,776 common
shares, which were issued on February 18, 2026 in connection with a previous amendment to the HCR Agreement (the “HCR
Warrants”), by reducing the exercise price of the HCR Warrants from $3.8130 per share to $0.10 per share; by adding a
provision that prohibits the exercise of the HCR Warrants if, upon giving effect to such exercise, the aggregate number of the
Company’s common shares beneficially owned by the holder (together with its affiliates and certain attribution parties) would
exceed 4.99% (or, 61 days after a written notice from such holder, any other percentage not in excess of 9.99%) of the number of the
Company’s common shares outstanding immediately after giving effect to the exercise, as such percentage ownership is
determined in accordance with the terms of the HCR Amendment; and removing the contractual restrictions on transfers of the HCR
Warrants and shares issuable upon exercise of the HCR Warrants before January 1, 2028. The effectiveness of the HCR Amendment is
conditioned upon the completion of the Private Placement by October 31, 2026 and effectiveness of the Loan Agreement Amendment. The
foregoing description of the HCR Amendment does not purport to be complete and is qualified in its entirety by reference to the HCR
Amendment, which is attached to this Current Report on Form 8-K as Exhibit 10.5.
Item 2.02. Results of Operations and Financial Condition.
On October 8, 2026, the Company issued a press release that includes the preliminary net product revenues from sales of ZYNLONTA for the quarter ended
September 30, 2026 and the preliminary cash and cash equivalents as of September 30, 2026. A copy of the press release is attached
as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.
The ZYNLONTA net product revenues and cash and cash equivalents figures
are preliminary and unaudited and reflect the Company’s estimated financial results. In preparing this information, management made
a number of complex and subjective judgments and estimates about the appropriateness of certain reported amounts and disclosures. The
Company’s actual financial results for the quarter ended September 30, 2026 have not yet been finalized by management. The preliminary financial information is not a comprehensive statement of all financial results
for the quarter ended September 30, 2026. Subsequent information or events may lead to material differences between the foregoing preliminary
financial results and those reported in the Company’s subsequent SEC filings. Accordingly, investors should not place undue reliance
on these preliminary financial results.
The information contained in this Item 2.02 and Exhibit 99.1 shall
not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 3.02. Unregistered Sales of Equity Securities.
The information set forth under Item 1.01 of this Current Report
on Form 8-K with regards to the Private Placement, the Lender Warrants and the HCR Warrants is incorporated by reference in this
Item 3.02.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
|
Exhibit Number |
Description |
| 10.1 |
Form of securities purchase agreement |
| 10.2 |
Form of pre-funded warrant |
| 10.3 |
Amendment to Loan Agreement, dated October 7, 2026, by and among ADC
Therapeutics SA, certain subsidiaries, the lenders party thereto and Blue Owl Opportunistic Lending Master Fund I, L.P., as
administrative agent and collateral agent |
| 10.4 |
Form of amendment to Lender Warrants |
| 10.5 |
Amendment No. 2 to the Purchase and Sale Agreement, dated October 7, 2026, by and among ADC Therapeutics SA and certain entities managed by Healthcare Royalty Management, LLC |
| 99.1 |
Press release dated October 8, 2026 |
| 104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
ADC Therapeutics SA |
| Date: October 13, 2026 |
|
| |
By: |
/s/ Peter J. Graham |
| |
Name: |
Peter J. Graham |
| |
Title: |
Chief Legal Officer |
Exhibit 99.1

ADC Therapeutics Announces Comprehensive Strategic
Financial Restructuring
Marking Key Capital Structure Improvements
$86.6 Million Private Placement announced, with
participation from new and existing investors, extending expected cash runway into 2029
HealthCare Royalty financing agreement amended,
removing change-of-control payment
Senior secure loan refinanced, decreasing principal
to $50M with bullet payment in August 2029 and no minimum liquidity
LAUSANNE, Switzerland — October 8, 2026 — ADC
Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced
a comprehensive strategic financial restructuring designed to strengthen its balance sheet, reduce leverage, and increase strategic optionality
to maximize shareholder value while extending the expected cash runway into 2029. The strategic initiative includes securing new equity
financing, restructuring the HealthCare Royalty (HCR) agreement, and reducing the outstanding loan principal.
“We are pleased to announce this robust set
of improvements to our capital structure which reflect confidence in ZYNLONTA’s growth potential from both long-standing and new
investors as well as from HCR and our lenders,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. “These efforts
extend our expected cash runway and increase strategic optionality, as we approach much anticipated LOTIS-7 and MZL data abstracts in
early November with presentations in December at the 68th American Society of Hematology Annual Meeting.”
Strategic Financing
ADC Therapeutics has entered into securities purchase
agreements for the sale of its equity securities to certain institutional investors, including new investor Bain Capital Life Sciences
and existing investors Redmile, TCGX, and Nantahala Capital, in a $86.6 million private investment in public equity (“PIPE”)
financing. In the PIPE, ADC Therapeutics is selling 12.9 million common shares at $1.42 per share and pre-funded warrants to purchase
48.1 million common shares at $1.32, per pre-funded warrant, which is the price per common share in the PIPE minus the exercise price
of CHF 0.08 per pre-funded warrant.
Gross proceeds from the PIPE, assuming cash exercise
of the pre-funded warrants, are anticipated to be approximately $86.6 million before deducting placement agent fees and offering
expenses. The PIPE is expected to close on October 22, 2026, subject to customary closing conditions. ADC Therapeutics
intends to use the net proceeds from the PIPE to
invest in continued funding of ZYNLONTA pipeline studies, including the Phase 3 trials in diffuse large B-cell lymphoma (ZYNLONTA plus
glofitamab) and marginal zone lymphoma (ZYNLONTA monotherapy), and strengthen the balance sheet, in addition to funding working capital
and general corporate purposes.
The offer and sale of the foregoing securities
are made in a transaction not involving a public offering, and the foregoing securities have not been registered under the Securities
Act of 1933, as amended (the “Securities Act”) or applicable state securities laws, and are being offered and sold in reliance
on Section 4(a)(2) of the Securities Act. The securities may not be reoffered or resold in the United States except pursuant to an effective
registration statement or an applicable exemption from the registration requirements of the Securities Act and other applicable securities
laws. ADC Therapeutics has agreed to file a registration statement with the Securities and Exchange Commission registering the resale
of the common shares to be sold in the PIPE and the common shares issuable upon exercise of the pre-funded warrants to be sold in the
PIPE.
Amendment to Royalty Purchase and Sale Agreement
On October 7, 2026, ADC Therapeutics entered into
Amendment No. 2 (the “HCR Amendment”) to its Purchase and Sale Agreement, dated August 25, 2021 (as amended from time to time,
the “HCR Agreement”), with certain entities managed by HealthCare Royalty Management, LLC (collectively, “HCR”).
To date, HCR has provided $300 million of funding to the Company. The HCR Amendment eliminates the $150 million payment otherwise required
solely upon a change of control.
In addition, the HCR Amendment reduces the aggregate
outstanding principal amount of third-party indebtedness of the Company and its subsidiaries are permitted to incur to $50.0 million.
An uncured breach of this debt limitation covenant entitles HCR to elect to receive the non-performance payment equaling 1.5 times the
difference between the $300 million aggregate purchase price and royalty payments and other qualifying credited amounts actually received
by HCR, subject to a cure period. The HCR Amendment also requires the Company, subject to shareholder approval and applicable legal and
fiduciary duties, to use its best efforts to become a Delaware corporation. In addition, the HCR Amendment amends the warrants to purchase
9,834,776 common shares, which were issued on February 18, 2026, in connection with a previous amendment to the HCR Agreement (the “HCR
Warrants”), by reducing the exercise price of the HCR Warrants from $3.8130 per share to $0.10 per share; by adding a provision
that prohibits the exercise of the HCR Warrants if, upon giving effect to such exercise, the aggregate number of the Company’s common
shares beneficially owned by the holder (together with its affiliates and certain attribution parties) would exceed 4.99% (or, 61 days
after a written notice from such holder, any other percentage not in excess of 9.99%) of the number of the Company’s common shares
outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of
the HCR Amendment; and removing the contractual restrictions on transfers of the HCR Warrants and shares issuable upon exercise of the
HCR Warrants before January 1, 2028. The effectiveness of the HCR Amendment is conditioned upon the completion of the PIPE by October
31, 2026, and the effectiveness of the Loan Agreement Amendment. All other terms of the HCR Agreement remain unchanged including the ongoing
royalty obligations which will continue until the Royalty Cap (as defined in the HCR Agreement).
Amendment to Loan Agreement
On October 7, 2026, ADC Therapeutics, certain
subsidiaries of the Company, the lenders party thereto and Blue Owl Opportunistic Lending Master Fund I, L.P., as administrative
agent and collateral agent, entered into a second amendment (the “Loan Agreement Amendment”) to the Loan Agreement and
Guaranty, dated August 15, 2022 (as amended from time to time, the “Loan Agreement”).
The Loan Agreement Amendment provides for the prepayment
of $70.0 million principal amount of term loans under the Loan Agreement, plus accrued and unpaid interest with respect thereto and any
related fees and premiums, inclusive of the Company’s scheduled September 30, 2026, amortization payment. Immediately after such
prepayment, the principal amount of outstanding term loans under the Loan Agreement will be $50.0 million. The Loan Agreement Amendment
eliminates subsequent scheduled principal amortization, with the remaining principal payable at maturity unless earlier accelerated; eliminates
the minimum liquidity covenant; and sets the minimum trailing four-quarter U.S. ZYNLONTA sales covenant at $65.0 million for the quarter
ending December 31, 2026, and each quarter thereafter. The effectiveness of the Loan Agreement Amendment, including the consummation of
the prepayment contemplated thereunder, is conditioned upon the completion of the PIPE.
In connection with the Loan Agreement Amendment,
the Company entered into amendments to the warrants to purchase an aggregate of 527,295 common shares, which were issued on August 15,
2022, in connection with the Loan Agreement (the “Lender Warrants”). The amendments reduce the exercise price of the Lender
Warrants from $8.30 per share to $1.00 per share (being the lesser of $1.00 per share and the price per common share in the PIPE). The
effectiveness of the amendments to the Lender Warrants is conditioned upon the effectiveness of the Loan Agreement Amendment.
The company expects net product revenues from
sales of ZYNLONTA to be approximately $21.0 million for the third quarter ended September 30, 2026 with cash and cash equivalents
totaling $189.2 million as of September 30, 2026. On a proforma basis, giving effect to the estimated net cash proceeds from
the PIPE of approximately $76.3 million (after deducting placement agent fees and estimated offering expenses), and the partial
principal prepayment of $69.6 million (including fees) on the senior secured term loan, the Company would have had approximately
$196 million of cash and cash equivalents as of that date.
Jefferies, Guggenheim Securities, and Cantor are
acting as placement agents for the PIPE. Davis Polk & Wardwell LLP and Homburger AG are acting as legal advisors to ADC Therapeutics.
This press release shall not constitute an offer
to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction
in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any
such state or other jurisdiction.
The Company has uploaded an updated corporate presentation
to the Investor portion of its website.
About ZYNLONTA®
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), transforming treatment for patients through our focused portfolio
with ZYNLONTA® (loncastuximab tesirine-lpyl).
ADC Therapeutics' CD19-directed ADC ZYNLONTA 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.
Headquartered in Lausanne (Biopôle), Switzerland,
with operations in New Jersey, ADC Therapeutics is focused on driving innovation in ADC development with specialized capabilities from
clinical to manufacturing and commercialization.
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", "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 adequacy of the LOTIS-5 clinical trial data to support full regulatory approval and our ability to maintain accelerated
approval in the United States and foreign jurisdictions for our product; our ability to identify and execute on potential regulatory and
compendia pathways; the timing, content and outcome of meetings with and feedback or other communications provided by regulatory authorities
including U.S. FDA including our ability to adequately address the serious concerns related to the LOTIS-5 trial results raised by the
FDA at the recent pre-sBLA submission meeting; the timing, submission and outcome of an sBLA related to LOTIS-5 and potential approval;
the actual and perceived benefit-risk profile for ZYNLONTA as studied in the LOTIS-5 trial; the assessment of the data from LOTIS-5 study,
including additional analyses of outcomes observed for safety, efficacy and within key geographic regions and across certain patient sub-populations;
the path for full regulatory approval for ZYNLONTA in the United States and foreign jurisdictions and into earlier lines of therapy; whether
future LOTIS-7 results will be consistent with or different from the prior disclosure, the timing, results and publication of the full
LOTIS-7 trial data and potential compendia inclusion; future regulatory strategy for a Phase 3 trial for the combination of ZYNLONTA plus
glofitamab; our expected revenue growth in 2027 and the Company's ability to sustain or grow ZYNLONTA® revenue in the future;
our ability to effect the proposed amendments to the HCR agreement and the loan agreement; our expected cash runway into at least 2028
which assumes use of the minimum liquidity amount required to be maintained under its loan agreement covenants; our ability to comply
with the terms of our indebtedness; changes in our regulatory and commercial strategy; the ability of our partners to commercialize ZYNLONTA®
in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain or maintain
regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing and results of the Company's clinical trials; the
timing, publication and results of investigator-initiated trials including those studying FL and MZL and the potential regulatory and/or
compendia strategy and the future opportunity; the timing and outcome of regulatory submissions for the Company's products or product
candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including
HealthCare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness,
the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service
such indebtedness; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial
activities; uncertainties related to a potential change in domicile from Switzerland to Delaware, including the outcome of tax analyses
associated with such redomiciliation, the receipt of requisite shareholder approval, and the ability to complete the redomiciliation on
the anticipated terms and timeline, if at all; and the uncertainties of international trade policies, including tariffs, sanctions, trade
barriers and most favored nation drug pricing and the potential impact they may have on our business, financial condition, and results
of operations. 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
10-K and in the Company's other periodic and current reports and filings with the U.S. 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 ZYNLONTA net sales and cash and
cash equivalents figures included in this press release are preliminary and unaudited and reflect the Company’s estimated financial
results. In preparing this information, management made a number of complex and subjective judgments and estimates about the appropriateness
of certain reported amounts and disclosures. The Company’s actual financial results for the quarter ended September 30, 2026 have
not yet been finalized by management. The preliminary financial information
is not a comprehensive statement of all financial results for the quarter ended September 30, 2026. Subsequent information or events may
lead to material differences between the foregoing preliminary financial results and those reported in the Company’s subsequent
SEC filings. Accordingly, investors should not place undue reliance on these preliminary financial results.
CONTACTS:
Investors & Media
Nicole Riley
ADC Therapeutics
Nicole.Riley@adctherapeutics.com
+1 862-926-9040