ADCT ADC Therapeutics SA

29.21
+1.07  (+4%)
Previous Close 28.14
Open 27.88
52 Week Low 20.01
52 Week High 46.2
Market Cap $2,286,266,700
Shares 78,270,000
Float 31,110,099
Enterprise Value $1,988,303,500
Volume 203,240
Av. Daily Volume 271,230
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Upcoming Catalysts

Drug Stage Catalyst Date
ZYNLONTA (Loncastuximab Tesirine) and RITUXAN (rituximab) - (LOTIS 5)
Diffuse Large B-Cell Lymphoma
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
ADCT-601 (mipasetamab uzoptirine)
Solid tumors
Phase 1b
Phase 1b
Phase 1b trial to be initiated 2H 2021.
ADCT-901
Phase 1
Phase 1
Phase 1 trial to be initiated 2H 2021.
ZYNLONTA (Loncastuximab Tesirine)
B-cell non-Hodgkin lymphoma
Phase 2
Phase 2
Trials to be initiated 2H 2021.
ZYNLONTA (loncastuximab tesirine) + IMBRUVICA (Ibrutinib) - (LOTIS-3)
Diffuse Large B-Cell or Mantle Cell Lymphoma
Phase 1/2
Phase 1/2
Phase 2 pivotal trial ongoing.
Camidanlumab tesirine
Hodgkin lymphoma (HL)
Phase 2
Phase 2
Phase 2 interim data presented June 22, 2021. Overall response rate (ORR) was 66.3% (67/101 patients) with a complete response rate (CRR) of 27.7% and partial response rate (PRR) of 38.6%. Median duration of response has not been reached.
Camidanlumab Tesirine and KEYTRUDA (pembrolizumab)
Solid Tumors
Phase 1b
Phase 1b
Phase 1b monotherapy data released at ASCO June 4, 2021.
ADCT-601
Solid tumors
Phase 1b
Phase 1b
Phase 1b trial to be initiated 1H 2022.
ZYNLONTA (Loncastuximab Tesirine)
Diffuse Large B-Cell Lymphoma
Approved
Approved
FDA approval announced April 23, 2021.

Latest News

  1. ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, today announced that the European Commission has granted Orphan Drug Designation to ZYNLONTA®, a CD19-targeted ADC, for the treatment of diffuse large B-cell lymphoma (DLBCL).

    "This Orphan Drug Designation recognizes the significant unmet need in patients with diffuse large B-cell lymphoma in the European Union (EU)," said Joseph Camardo, MD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "We are committed to providing global access to ZYNLONTA for as many patients as may benefit. This designation is an important step in our collaboration…

    ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, today announced that the European Commission has granted Orphan Drug Designation to ZYNLONTA®, a CD19-targeted ADC, for the treatment of diffuse large B-cell lymphoma (DLBCL).

    "This Orphan Drug Designation recognizes the significant unmet need in patients with diffuse large B-cell lymphoma in the European Union (EU)," said Joseph Camardo, MD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "We are committed to providing global access to ZYNLONTA for as many patients as may benefit. This designation is an important step in our collaboration with EMA for our marketing authorization in the EU."

    Orphan Drug Designation in the EU is granted by the European Commission based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products (COMP). It is intended to encourage the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases. If approved for marketing, this designation will provide ten years of marketing exclusivity and also provide special incentives for sponsors, including eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees.

    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) has 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. This indication is approved by the FDA under accelerated 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.

    The FDA approval was based on data from LOTIS-2, a large (n=145) Phase 2 multinational, single-arm clinical trial of ZYNLONTA for the treatment of adult patients with r/r DLBCL following two or more prior lines of systemic therapy. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with very difficult to treat disease, including patients with high-grade B-cell lymphoma. The trial enrolled 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 transplants and CAR-T therapy prior to their treatment with ZYNLONTA. Results from the trial demonstrated an overall response rate (ORR) of 48.3% (70/145 patients), which included a complete response (CR) rate of 24.1% (35/145 patients) and a partial response (PR) rate of 24.1% (35/145 patients). Patients had a median time to response of 1.3 months. At the most recent data cut-off for patients enrolled in the trial, the median duration of response (mDoR) was 13.4 months. In a pooled safety population the most common adverse reactions (≥20%) were thrombocytopenia, gamma-glutamyltransferase increased, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea and musculoskeletal pain. In LOTIS-2, the most common (≥10%) grade ≥3 treatment-emergent adverse events were neutropenia (26.2%), thrombocytopenia (17.9%), gamma-glutamyltransferase increased (17.2%) and anemia (10.3%).

    ZYNLONTA is being evaluated in combination for earlier lines of therapy and as a monotherapy in other B-cell malignancies.

    About ADC Therapeutics

    ADC Therapeutics (NYSE:ADCT) is a commercial-stage biotechnology company improving the lives of cancer patients with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.

    ADC Therapeutics' CD19-directed ADC ZYNLONTA® (loncastuximab tesirine-lpyl) is approved by the FDA for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in late-stage clinical trials in combination with other agents. Cami (camidanlumab tesirine) is being evaluated in a late-stage clinical trial for relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, the Company has multiple PBD-based 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 Twitter and LinkedIn.

    ZYNLONTA® is a registered trademark of ADC Therapeutics SA.

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  2. ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, announced today that Joseph Camardo, MD, Chief Medical Officer, and Jennifer Herron, Chief Commercial Officer, will participate in a fireside chat at Morgan Stanley's 19th Annual Global Healthcare Conference on Tuesday, September 14th at 8:45 a.m. ET.

    A live webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics' website, ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 days.

    About ADC

    ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, announced today that Joseph Camardo, MD, Chief Medical Officer, and Jennifer Herron, Chief Commercial Officer, will participate in a fireside chat at Morgan Stanley's 19th Annual Global Healthcare Conference on Tuesday, September 14th at 8:45 a.m. ET.

    A live webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics' website, ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 days.

    About ADC Therapeutics

    ADC Therapeutics (NYSE:ADCT) is a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.

    ADC Therapeutics' CD19-directed ADC ZYNLONTA® (loncastuximab tesirine-lpyl) is approved by the FDA 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. Cami (camidanlumab tesirine) is being evaluated in a late-stage clinical trial for relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics has multiple PBD-based 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 Twitter and LinkedIn.

    ZYNLONTA® is a registered trademark of ADC Therapeutics SA.

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  3. ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, announced today that Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer, will depart the company to pursue a new opportunity. ADCT is pleased to announce that Joseph Camardo, MD, will be appointed Senior Vice President and Chief Medical Officer.

    "Jay Feingold has played a key role in the growth of ADC Therapeutics over the last seven years and was instrumental in establishing our clinical team and strategy leading to the approval of our first commercial therapy, ZYNLONTA®…

    ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, announced today that Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer, will depart the company to pursue a new opportunity. ADCT is pleased to announce that Joseph Camardo, MD, will be appointed Senior Vice President and Chief Medical Officer.

    "Jay Feingold has played a key role in the growth of ADC Therapeutics over the last seven years and was instrumental in establishing our clinical team and strategy leading to the approval of our first commercial therapy, ZYNLONTA®," said Chris Martin, PhD, Chief Executive Officer. "We are grateful for his leadership, expertise and steadfast dedication to patients, and we wish him well in his next endeavor." Dr. Feingold will continue to consult with ADCT through 2022 to ensure a smooth transition.

    Dr. Camardo joined ADC Therapeutics from Celgene Corporation, where he was most recently Senior Vice President of Celgene Global Health after having served as Senior Vice President of Global Medical Affairs and Corporate Medical Operations. Prior to Celgene, Dr. Camardo was Senior Vice President of Clinical Development and Medical Affairs at Forest Research Institute and spent more than 20 years at Wyeth Research before its acquisition by Pfizer. At Wyeth, he held several leadership roles including Senior Vice President of Clinical Research and Development.

    "Dr. Camardo's extensive background in clinical development and Medical Affairs makes him the ideal successor and ensures a seamless evolution of our company. Dr. Camardo worked closely with Dr. Feingold for the last 18 months and together they ensured our first marketed product was well-received by the physician community in the United States and beyond," continued Chris Martin.

    "On behalf of the Board of Directors, I am delighted to welcome Dr. Camardo to the pivotal role of Chief Medical Officer," said Ron Squarer, Chairman of the Board and an advisor to the company. "The Board has worked closely with Joe Camardo on several critical projects and appreciates his vast and deep industry experience, as well as his passion for patients."

    About ADC Therapeutics

    ADC Therapeutics (NYSE:ADCT) is a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.

    ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) is approved by the FDA 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. Cami (camidanlumab tesirine) is being evaluated in a late-stage clinical trial for relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics has multiple PBD-based 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 Twitter and LinkedIn.

    ZYNLONTA® is a registered trademark of ADC Therapeutics SA.

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  4. ADCT sells capped royalty interest on ZYNLONTATM and Cami for $225 million upon closing with an additional $100 million in potential near-term milestone payments

    Royalty of 7% terminates upon payment of 2.25x to 2.50x the purchase price

    Proceeds to be used for continued development and commercialization of ZYNLONTATM and Cami

    ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, today announced it had entered into a royalty purchase agreement with HealthCare Royalty Partners (HealthCare Royalty).

    Under the terms of the $325 million financing agreement, ADC Therapeutics will receive $225 million upon…

    ADCT sells capped royalty interest on ZYNLONTATM and Cami for $225 million upon closing with an additional $100 million in potential near-term milestone payments

    Royalty of 7% terminates upon payment of 2.25x to 2.50x the purchase price

    Proceeds to be used for continued development and commercialization of ZYNLONTATM and Cami

    ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, today announced it had entered into a royalty purchase agreement with HealthCare Royalty Partners (HealthCare Royalty).

    Under the terms of the $325 million financing agreement, ADC Therapeutics will receive $225 million upon closing, and is eligible to receive an additional $75 million upon the first commercial sale of ZYNLONTATM (loncastuximab tesirine) in Europe and an additional $25 million upon the achievement of a near-term commercial milestone for ZYNLONTA. In exchange, HealthCare Royalty will receive a 7% royalty on worldwide net sales and licensing revenue from ZYNLONTA, with the exception of greater China, Singapore and South Korea, and a 7% royalty on worldwide net sales and licensing revenue from Cami (camidanlumab tesirine) (subject to limited carve-outs). Based on performance tests in 2026 and 2027, these royalty rates are subject to potential upward adjustment, up to a maximum of 10%. The total royalty payable by ADCT to HealthCare Royalty is capped in the range of 2.25x to 2.50x of the amount paid to ADCT, dependent upon the amount of royalties paid by 2029. Once the cap is hit, the agreement terminates. Upon closing of this transaction, and together with the Company's current cash balance and anticipated business plan, ADC Therapeutics will have a substantial multi-year working capital runway.

    "This transaction reflects the significant value of ZYNLONTA and Cami. We are delighted to partner with HealthCare Royalty, a leading healthcare investment firm, to continue the development and commercialization of ZYNLONTA in combination with other drugs, in earlier lines of therapy and in new histologies, as well as to continue our development and commercialization plans for Cami," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "With this transaction, we are well-positioned to continue executing on our plans and improving the lives of patients."

    "We are pleased to partner with ADC Therapeutics to reach their vision of developing and commercializing potent and targeted ADCs for patients with hematological malignancies and solid tumors," said Clarke Futch, Chairman and Chief Executive Officer of HealthCare Royalty. "Our investment reflects our belief in both ZYNLONTA and Cami to deliver value, and underscores our mission to facilitate innovation by high growth biopharmaceutical companies globally."

    The agreement includes customary provisions for a transaction of this nature, a repayment provision at the Company's option, and change of control provisions. The Company expects to close the transaction in early September. The Company has concurrently filed a Form 6-K which includes further details.

    Morgan Stanley & Co. LLC acted as Sole Structuring Agent and Ropes & Gray LLP and Davis Polk LLP acted as legal advisors to ADC Therapeutics on the transaction. Gibson Dunn LLP acted as legal advisors to HealthCare Royalty.

    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, evading DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

    The U.S. Food and Drug Administration (FDA) has 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 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.

    ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

    About Camidanlumab Tesirine (Cami)

    Camidanlumab tesirine (Cami, formerly ADCT-301) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax®-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, Cami is internalized into the cell where enzymes release the PBD-based payload, killing the cell. This applies to CD25-expressing tumor cells and also to CD25-expressing Tregs. The intra-tumoral release of its PBD payload may also cause bystander killing of neighboring tumor cells, and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity.

    Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.

    About ADC Therapeutics

    ADC Therapeutics (NYSE:ADCT) is a commercial-stage biotechnology company improving the lives of cancer patients with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.

    ADC Therapeutics' CD19-directed ADC ZYNLONTA™ (loncastuximab tesirine-lpyl) is approved by the FDA for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in late-stage clinical trials in combination with other agents. Cami (camidanlumab tesirine) is being evaluated in a late-stage clinical trial for relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, the Company has multiple PBD-based 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 Twitter and LinkedIn.

    ZYNLONTA™ is a trademark of ADC Therapeutics SA.

    About HealthCare Royalty

    HealthCare Royalty purchases royalties and uses debt-like structures to invest in commercial or near-commercial stage life science assets. HealthCare Royalty has $5.8 billion in cumulative capital commitments with offices in Stamford (CT), San Francisco, Boston and London. For more information, visit www.healthcareroyalty.com.

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  5. - Encouraging initial launch of ZYNLONTA™ (loncastuximab tesirine-lpyl) driven by favorable product profile to address high unmet medical need in relapsed / refractory DLBCL market

    - Company to host conference call today at 8:30 a.m. EDT

    ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, today reported financial results for the second quarter ended June 30, 2021 and provided business updates.

    "We were thrilled to receive accelerated FDA approval for the first indication for ZYNLONTA and are encouraged by the momentum and positive feedback in…

    - Encouraging initial launch of ZYNLONTA™ (loncastuximab tesirine-lpyl) driven by favorable product profile to address high unmet medical need in relapsed / refractory DLBCL market

    - Company to host conference call today at 8:30 a.m. EDT

    ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, today reported financial results for the second quarter ended June 30, 2021 and provided business updates.

    "We were thrilled to receive accelerated FDA approval for the first indication for ZYNLONTA and are encouraged by the momentum and positive feedback in the initial weeks following approval. We remain highly focused on the successful execution of the launch and positive about the longer-term potential of the product," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "During the second quarter, we were also pleased to present positive data on ZYNLONTA and our exciting pipeline of advancing programs at key medical meetings. Looking to the rest of the year, we have several notable milestones on the horizon and look forward to keeping you updated on our progress."

    Recent Highlights and Developments

    ZYNLONTA (loncastuximab tesirine-lpyl)

    • Launch update:
      • ZYNLONTA generated net sales of $3.8 million for the two-month period following accelerated U.S. Food and Drug Administration (FDA) approval on April 23, 2021, reflecting patient demand with no material inventory build. Launch performance was driven by the differentiated profile of ZYNLONTA in addressing an area of high unmet medical need.
      • The Company has engaged prioritized accounts, with patient starts at a significant percentage of key accounts. A substantial number of the National Comprehensive Cancer Network (NCCN) centers have ordered and reordered ZYNLONTA. There has been positive reception across the treatment site spectrum from academic- to community-based centers reflecting the broad applicability of ZYNLONTA in the 3L+ setting supported by the LOTIS-2 pivotal data.
      • ZYNLONTA was added to the NCCN Guidelines with a Category 2A recommendation just two weeks after receiving accelerated FDA approval. The NCCN guidelines listing is consistent with the broad FDA-approved indication. As a result, payer access and medical policy publication have accelerated.
      • The Company is pleased with the positive launch momentum in a continuing COVID environment. The sales and medical teams are executing with a hybrid model, and there has been an increase in face-to-face visits.
    • Online publication of LOTIS-2 results in The Lancet Oncology: Results of LOTIS-2, a Phase 2 clinical trial evaluating the safety and efficacy of single-agent ZYNLONTA in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following two or more systemic treatments, were published in The Lancet Oncology. The trial included patients with high-risk characteristics for poor prognosis, such as double-/triple-hit, transformed, and primary refractory DLBCL.
    • Phase 2 LOTIS-2 trial update at ASCO and ICML: Updated clinical data from LOTIS-2, the pivotal Phase 2 trial of ZYNLONTA in patients with relapsed or refractory DLBCL, were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and the International Conference on Malignant Lymphoma (ICML), both in June 2021. As of the March 1, 2021 cutoff date, the overall response rate (ORR) was 48.3% and the complete response rate (CRR) was 24.8%. At this data cut, there was a median duration of response of 13.4 months for the responders, with durable responses in high-risk subgroups. No new safety concerns were identified during the study.
    • Other ZYNLONTA trials:
      • The Phase 3 LOTIS-5 clinical trial is evaluating ZYNLONTA in combination with rituximab in second-line patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant.
      • The Phase 2 LOTIS-3 clinical trial of ZYNLONTA in combination with ibrutinib for relapsed or refractory DLBCL patients continues to enroll patients. Updated Phase 1 results presented at ICML demonstrated ORR of 62.2%, CRR of 35.1% and a manageable toxicity profile. Based on interim data from the Phase 2 trial, the Company plans to amend the protocol to evaluate the administration of ZYNLONTA with every cycle to potentially further enhance efficacy and durability. Based on this additional data, the Company could potentially pursue a Phase 3 study in second-line DLBCL, expanding the addressable market and the number of patients who could benefit from ZYNLONTA.
      • The pivotal Phase 2 LOTIS-6 clinical trial in patients with relapsed or refractory follicular lymphoma (FL) is open for enrollment.
      • The Company plans to initiate a clinical trial to evaluate ZYNLONTA in combination with select therapies in B-cell non-Hodgkin lymphoma (NHL).
      • The Company plans to initiate a dose-finding study to evaluate ZYNLONTA in combination with R-CHOP in frontline DLBCL.

    Camidanlumab Tesirine (Cami)

    • Pivotal Phase 2 trial in Hodgkin lymphoma (HL): Encouraging interim results from the pivotal Phase 2 study in patients with relapsed or refractory HL were presented at ICML. In a heavily pre-treated patient population with a median of six prior lines of systemic therapy, these results included an ORR of 66.3% and CRR of 27.7%. Median duration of response has not been reached, and no new safety signals were identified.
    • Phase 1b trial in solid tumors: The Phase 1b clinical trial, enrolling patients with selected advanced solid tumors, is an open-label, dose-escalation and dose-expansion trial evaluating the safety, tolerability, pharmacokinetics and antitumor activity of Cami in combination with pembrolizumab, a checkpoint inhibitor.

    ADCT-901

    • The FDA has cleared the Investigational New Drug (IND) application for ADCT-901, targeting KAAG-1. The Company expects to initiate the Phase 1 study in the second half of 2021.

    Corporate Update

    • Geographic Expansion: ADC Therapeutics is committed to expanding its geographic footprint in order to provide ZYNLONTA and other novel treatments to patients who can benefit from them.
      • The Company expects to submit a regulatory filing in the second half of 2021 to the European Medicines Agency (EMA) for ZYNLONTA for the treatment of patients with relapsed or refractory DLBCL.
      • The Overland ADCT BioPharma joint venture in China is making good progress toward initiating a pivotal bridging study and seasoned executive Eric Koo was appointed CEO during the second quarter.

    Upcoming Expected Milestones

    ZYNLONTA

    • Initiate a dose-finding study of ZYNLONTA in first-line DLBCL with R-CHOP in the second half of 2021.
    • Initiate a clinical study to evaluate ZYNLONTA in multiple combinations in B-cell non-Hodgkin lymphoma in the second half of 2021.
    • Complete safety lead-in of the Phase 3 LOTIS-5 confirmatory study of ZYNLONTA in combination with rituximab in the second half of 2021.
    • Continue enrollment in the Phase 2 LOTIS-3 study of ZYNLONTA in combination with ibrutinib in the second half of 2021.

    Earlier-Stage Pipeline

    • Initiate Phase 1 study of ADCT-901, targeting KAAG1, in the second half of 2021.
    • Initiate a Phase 1b combination study of ADCT-601 (mipasetamab uzoptirine), targeting AXL, in multiple solid tumors in the first half of 2022.

    Second Quarter 2021 Financial Results

    Cash and Cash Equivalents

    Cash and cash equivalents were $371.9 million as of June 30, 2021, compared to $439.2 million as of December 31, 2020. During the second quarter of 2021, the Company drew down $50 million under its Convertible Credit Facility with Deerfield, which was contingent upon ZYNLONTA approval.

    Research and Development (R&D) Expenses

    R&D expenses were $39.5 million for the quarter ended June 30, 2021, compared to $26.0 million for the same quarter in 2020. R&D expenses increased due to investments in programs supporting the ZYNLONTA commercial launch and evaluating the potential of ZYNLONTA in earlier lines of treatment and additional histologies, and due to advancing the portfolio. As a result of these initiatives, employee headcount and share-based compensation expense increased.

    Selling and Marketing (S&M) Expenses

    During the second quarter of 2021, S&M expenses were $15.2 million, compared to $4.0 million for the same quarter in 2020. The increase in S&M expenses was related to the launch of ZYNLONTA. Prior to December 31, 2020, S&M expenses were reported within General and Administrative ("G&A") expenses within the condensed consolidated interim statement of operations. The period ended June 30, 2020 has been recast to conform to the current year presentation.

    G&A Expenses

    G&A expenses were $19.4 million for the quarter ended June 30, 2021, compared to $15.0 million for the same quarter in 2020. G&A expenses increased due to higher headcount to support the commercial launch, increased share-based compensation expense and higher costs of being a public company.

    Net Loss and Adjusted Net Loss

    Net loss was $72.6 million, or a net loss of $0.95 per basic and diluted share, for the quarter ended June 30, 2021, compared to $126.6 million, or a net loss of $2.01 per basic and diluted share, for the same quarter in 2020. Net loss included share-based compensation expense of $18.3 million for the quarter ended June 30, 2021, compared to $12.7 million for the same quarter in 2020. In addition, net loss for the quarter ended June 30, 2021 includes a $2.1 million non-cash gain related to the changes in fair value of derivatives associated with the convertible loans under the Convertible Credit Facility with Deerfield, compared to a $79.3M charge for the same quarter in 2020. The decrease in fair value for the quarter ended June 30, 2021 was driven by the decrease in the Company's share price from March 31, 2021. The increase in fair value for the quarter ended June 30, 2020 was driven by the increase in the Company's share price from the April 2020 inception of the derivative.

    Adjusted net loss was $53.7 million, or an adjusted net loss of $0.70 per basic and diluted share, for the quarter ended June 30, 2021, compared to $32.1 million, or an adjusted net loss of $0.51 per basic and diluted share, for the same quarter in 2020. The increase in adjusted net loss was primarily driven by the expansion of the organization, investment in the expanding clinical portfolio and the preparation for the launch of ZYNLONTA.

    Conference Call Details

    ADC Therapeutics management will host a conference call and live audio webcast to discuss second quarter 2021 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the live call, please dial 833-303-1198 (domestic) or +1 914-987-7415 (international) and provide confirmation number 6962756. A live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

    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) has 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 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.

    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 biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.

    ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) is approved by the FDA 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. Cami (camidanlumab tesirine) is being evaluated in a late-stage clinical trial for relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics has multiple PBD-based 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 Twitter and LinkedIn.

    ZYNLONTA™ is a trademark of ADC Therapeutics SA.

    Use of Non-IFRS Financial Measures

    In addition to financial information prepared in accordance with IFRS, this document also contains certain non-IFRS financial measures based on management's view of performance including:

    • Adjusted net loss
    • Adjusted net loss per share

    Management uses such measures internally when monitoring and evaluating our operational performance, generating future operating plans and making strategic decisions regarding the allocation of capital. We believe that these adjusted financial measures provide useful information to investors and others in understanding and evaluating our operating results in the same manner as our management and facilitate operating performance comparability across both past and future reporting periods. These non-IFRS measures have limitations as financial measures and should be considered in addition to, and not in isolation or as a substitute for, the information prepared in accordance with IFRS. When preparing these supplemental non-IFRS measures, management typically excludes certain IFRS items that management does not believe are indicative of our ongoing operating performance. Furthermore, management does not consider these IFRS items to be normal, recurring cash operating expenses; however, these items may not meet the IFRS definition of unusual or non-recurring items. Since non-IFRS financial measures do not have standardized definitions and meanings, they may differ from the non-IFRS financial measures used by other companies, which reduces their usefulness as comparative financial measures. Because of these limitations, you should consider these adjusted financial measures alongside other IFRS financial measures.

    The following items are excluded from adjusted net loss and adjusted net loss per share:

    Shared-Based Compensation Expense: We exclude share-based compensation expense from our adjusted financial measures because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued. Share-based compensation expense has been, and will continue to be for the foreseeable future, a recurring expense in our business and an important part of our compensation strategy.

    Certain Other Items: We exclude certain other significant items that may occur occasionally and are not normal, recurring operating expenses, cash or non-cash, from our adjusted financial measures. Such items are evaluated by management on an individual basis based on both quantitative and qualitative aspects of their nature and generally represent items that, either as a result of their nature or significance, management would not anticipate occurring as part of our normal business on a regular basis. While not all-inclusive, examples of certain other significant items excluded from our adjusted financial measures would be: changes in the fair value of derivatives, the gain recognized in connection with the receipt of the USD 50.0 million disbursement, establishment of the embedded derivative and residual loan, elimination of the derivative immediately prior to FDA approval of ZYNLONTA, the effective interest expense associated with the Facility Agreement with Deerfield, transaction costs associated with debt or equity issuances that are expensed pursuant to IFRS, as well as the non-cash gain related to the contribution of our intellectual property for our equity interest in Overland ADCT BioPharma.

    See the attached Reconciliation of IFRS Measures to Non-IFRS Measures for explanations of the amounts excluded and included to arrive at the non-IFRS financial measures for the three-month periods ended June 30, 2021 and 2020.

    Forward-Looking Statements

    This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business and commercialization strategy, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, planned commercialization activities, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are based on our management's beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

    ADC Therapeutics SA

    Condensed Consolidated Interim Statement of Operations (Unaudited)

    (in KUSD except for share and per share data)

     

    Three Months Ended

    June 30,

    Six Months Ended

    June 30,

    2021

    2020 (1)

    2021

    2020 (1)

    Product revenues, net

    3,760

     

    -

     

    3,760

     

    -

     

     
    Operating expense
    Cost of product sales

    (121

    )

    -

     

    (121

    )

    -

     

    Research and development expenses

    (39,533

    )

    (25,950

    )

    (78,705

    )

    (61,325

    )

    Selling and marketing expenses

    (15,221

    )

    (4,004

    )

    (29,132

    )

    (6,632

    )

    General and administrative expenses

    (19,367

    )

    (14,995

    )

    (36,949

    )

    (20,877

    )

    Total operating expense

    (74,242

    )

    (44,949

    )

    (144,907

    )

    (88,834

    )

    Loss from operations

    (70,482

    )

    (44,949

    )

    (141,147

    )

    (88,834

    )

     
    Other income (expense)
    Other income

    199

     

    130

     

    393

     

    278

     

    Convertible loans, derivatives, change in fair value income (expense)

    2,053

     

    (79,261

    )

    23,222

     

    (79,261

    )

    Convertible loans, derivatives, transaction costs

    (148

    )

    (1,571

    )

    (148

    )

    (1,571

    )

    Share of results with joint venture

    (1,169

    )

    -

     

    (1,696

    )

    -

     

    Financial income

    15

     

    195

     

    30

     

    569

     

    Financial expense

    (2,555

    )

    (897

    )

    (4,555

    )

    (939

    )

    Exchange differences (loss) income

    (242

    )

    (100

    )

    152

     

    (71

    )

    Total other (expense) income

    (1,847

    )

    (81,504

    )

    17,398

     

    (80,995

    )

    Loss before taxes

    (72,329

    )

    (126,453

    )

    (123,749

    )

    (169,829

    )

    Income tax expense

    (240

    )

    (104

    )

    (347

    )

    (204

    )

    Net loss

    (72,569

    )

    (126,557

    )

    (124,096

    )

    (170,033

    )

     
    Net loss attributable to:
    Owners of the parent

    (72,569

    )

    (126,557

    )

    (124,096

    )

    (170,033

    )

     
    Net loss per share, basic and diluted

    (0.95

    )

    (2.01

    )

    (1.62

    )

    (2.97

    )

    (1) Prior period has been recast to conform S&M expenses to the current period presentation.
    ADC Therapeutics SA

    Condensed Consolidated Interim Balance Sheet (Unaudited)

    (in KUSD)

     

    June 30,

    2021

    December 31,

    2020

    ASSETS
    Current assets
    Cash and cash equivalents

    371,884

     

    439,195

     

    Accounts receivable, net

    2,079

     

    -

     

    Inventory

    7,718

     

    -

     

    Other current assets

    12,751

     

    11,255

     

    Total current assets

    394,432

     

    450,450

     

    Non-current assets
    Property, plant and equipment

    3,261

     

    1,629

     

    Right-of-use assets

    8,077

     

    3,129

     

    Intangible assets

    12,010

     

    10,179

     

    Interest in joint venture

    46,212

     

    47,908

     

    Other long-term assets

    394

     

    397

     

    Total non-current assets

    69,954

     

    63,242

     

     
    Total assets

    464,386

     

    513,692

     

     
    LIABILITIES AND EQUITY
    Current liabilities
    Accounts payable

    14,631

     

    5,279

     

    Other current liabilities

    29,450

     

    30,375

     

    Lease liabilities, short-term

    988

     

    1,002

     

    Current income tax payable

    237

     

    149

     

    Convertible loans, short-term

    6,193

     

    3,631

     

    Total current liabilities

    51,499

     

    40,436

     

    Non-current liabilities
    Convertible loans, long-term

    84,648

     

    34,775

     

    Convertible loans, derivatives

    49,619

     

    73,208

     

    Deferred gain of joint venture

    23,539

     

    23,539

     

    Lease liabilities, long-term

    7,612

     

    2,465

     

    Defined benefit pension liabilities

    3,551

     

    3,543

     

    Other non-current liabilities

    -

     

    221

     

    Total non-current liabilities

    168,969

     

    137,751

     

     
    Total liabilities

    220,468

     

    178,187

     

     
    Equity attributable to owners of the parent
    Share capital

    6,445

     

    6,314

     

    Share premium

    981,290

     

    981,056

     

    Treasury shares

    (134

    )

    (4

    )

    Other reserves

    74,971

     

    42,753

     

    Cumulative translation adjustment

    301

     

    245

     

    Accumulated losses

    (818,955

    )

    (694,859

    )

    Total equity attributable to owners of the parent

    243,918

     

    335,505

     

     
    Total liabilities and equity

    464,386

     

    513,692

     

    ADC Therapeutics SA

    Reconciliation of IFRS Measures to Non-IFRS Measures (Unaudited)

    (in KUSD except for share and per share data)

     

    Three Months Ended June 30,

    Six Months Ended June 30,

    in KUSD (except for share and per share data)

    2021

    2020

    2021

    2020

    Net loss

    (72,569

    )

    (126,557

    )

    (124,096

    )

    (170,033

    )

    Adjustments:
    Share-based compensation expense (i)

    18,267

     

    12,734

     

    32,218

     

    16,524

     

    Convertible loans, derivatives, change in fair value (ii)

    (2,053

    )

    79,261

     

    (23,222

    )

    79,261

     

    Convertible loans, first and second tranche, derivatives, transaction costs (iii)

    148

     

    1,571

     

    148

     

    1,571

     

    Effective interest expense (iv)

    2,450

     

    868

     

    4,432

     

    868

     

    Adjusted net loss

    (53,757

    )

    (32,123

    )

    (110,520

    )

    (71,809

    )

     
    Net loss per share, basic and diluted

    (0.95

    )

    (2.01

    )

    (1.62

    )

    (2.97

    )

    Adjustment to net loss per share, basic and diluted

    0.25

     

    1.50

     

    0.18

     

    1.72

     

    Adjusted net loss per share, basic and diluted

    (0.70

    )

    (0.51

    )

    (1.44

    )

    (1.25

    )

    Weighted average shares outstanding, basic and diluted

    76,728,714

     

    62,863,866

     

    76,725,210

     

    57,225,939

     

    (i)

    Share-based compensation expense represents the cost of equity awards issued to our directors, management and employees. The fair value of awards is computed at the time the award is granted and is recognized over the vesting period of the award by a charge to the income statement and a corresponding increase in other reserves within equity. These accounting entries have no cash impact.

     

    (ii)

    Change in the fair value of the convertible loan derivatives results from the valuation at the end of each accounting period of the derivatives associated with the convertible loans as well as the gain recognized in connection with the receipt of the USD 50.0 million, establishment of the embedded derivative and residual loan associated with the Deerfield facility and elimination of the derivative immediately prior to FDA approval of ZYNLONTA during the second quarter of 2021, as explained in note 13, "Convertible notes" to the unaudited condensed consolidated interim financial statements. There are several inputs to these valuations, but those most likely to provoke significant changes in the valuations are changes in the value of the underlying instrument (i.e., changes in the price of our common shares) and changes in expected volatility in that price. These accounting entries have no cash impact.

     

    (iii)

    The transaction costs allocated to the convertible loan first and second tranche derivatives represent actual costs. These are not expected to recur on an ongoing basis.

     

    (iv)

    Effective interest expense relates to the increase in the value of our convertible loans in accordance with the effective interest method. As the initial value of the loans are recorded net of the value of the embedded derivatives, the increase in the loan value necessary to attain the amounts necessary to fund the cash outflows of interest payments, repayments of capital and exit fees are considerably higher than the payments of interest at coupon rate and of the exit fee.

     

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