On March 3, 2022 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported that a new, wholly owned subsidiary of Lucid, LucidDx Labs Inc. ("LucidDx Labs") has acquired from ResearchDx, Inc. ("RDx"), a CLIA-certified, CAP-accredited clinical laboratory operator located in Irvine, CA, certain licenses and other related assets necessary for LucidDx Labs to operate its own new CLIA-certified, CAP-accredited clinical laboratory located in Lake Forest, CA (the "Laboratory") (Press release, Lucid Diagnostics, MAR 3, 2022, View Source [SID1234609489]). RDx had performed Lucid’s EsoGuard Esophageal DNA Test ("EsoGuard") since its transfer from a university research laboratory and its commercial launch as a Laboratory Developed Test ("LDT"). LucidDx Labs has begun performing EsoGuard testing at the Laboratory, including DNA extraction and bisulfite-converted next-generation sequencing ("NGS"), on surface esophageal cells collected using Lucid’s EsoCheck Esophageal Cell Collection Device ("EsoCheck") from at-risk patients with Gastroesophageal Reflux Disease ("GERD"), also known as chronic heartburn or acid reflux.

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"This critical milestone is the culmination of a lot of highly collaborative work over the past few months by our team and our outstanding partners at ResearchDx"

"This critical milestone is the culmination of a lot of highly collaborative work over the past few months by our team and our outstanding partners at ResearchDx," said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. "Having our own CLIA/CAP laboratory to perform EsoGuard testing will markedly streamline and simplify numerous important processes, including EsoGuard billing and collections. More fundamentally, it provides us with a strong, long-term, scalable infrastructure to accommodate accelerating growth in testing volume from our expanding EsoGuard commercialization activities."

LucidDx Labs and RDx also entered into a management services agreement pursuant to which RDx will continue to provide personnel and services to support the performance of EsoGuard at the Laboratory. Concurrently, LucidDx Labs entered into an agreement to lease the building in Lake Forest, CA where the Laboratory operates from an affiliate of RDx. The Laboratory has acquired, installed, and qualified all the necessary technology and equipment to perform the EsoGuard assay, completed the necessary assay validations to process clinical samples as an LDT, completed a College of American Pathologists ("CAP") audit, and begun performing EsoGuard testing at the new facility. Protocols to initiate formal transfer of the Clinical Laboratory Information Act ("CLIA") certificate as well as relevant state licenses have commenced. Further details on this acquisition and the launch of the laboratory can be found in a Current Report filed today with the Securities and Exchange Commission on Form 8-K.

About EsoGuard and EsoCheck

Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC"). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.

Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment.

The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard and EsoCheck are the missing element and constitute the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients.

EsoGuard is a bisulfite-converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck which quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s third-party CLIA-certified laboratory partner for EsoGuard testing.

On March 3, 2022 Modulus Discovery, Inc., a preclinical-stage computation-driven drug discovery firm, reported the successful closing of its Series C funding round in the amount of 2.34B JPY (approximately $20.4M USD) (Press release, Modulus Discovery, MAR 3, 2022, View Source [SID1234609488]). Series C investors include Green Coinvest Investment Limited Partnership., SBI Group., Heights Capital Management, Inc., and existing shareholders including UTokyo Innovation Platform Co., Ltd., JAFCO Group Co., Ltd., Keio Innovation Initiative, Inc. (KII), and Fast Track Initiative, Inc. Modulus has raised to date, a total of 5.86B JPY (approximately $51M USD).

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Modulus will use the proceeds to further its portfolio of R&D programs driven by its proprietary computational drug discovery platform and globally networked operational model. In addition to accelerating its existing pipeline of over 10 R&D programs, the company aims to significantly increase its business value through expansion of its platform infrastructure, collaborations with industry and academic partners, and increase personnel in R&D and operations to deliver innovative drug candidates through clinical partnerships and additional drug discovery collaborations.

Comment from S. Roy Kimura, Ph.D., Co-founder and CEO:
"We are very excited to announce the close of our Series C round, including follow-on investments from our existing shareholders and participation from new investors. We’d like to thank our current shareholders who have supported us over the years, and welcome our new investors who share our vision to sustainably discover and deliver multiple game-changing therapeutic candidates. With the support of our shareholders over the last 5 years, we have built, validated, and applied our versatile and efficient simulation-driven platform. Since the launch of our discovery portfolio in 2018, we have achieved positive results in multiple in vivo disease model proof-of-concept studies for 3 of our most advanced lead programs. Our next step is to launch first-in-human clinical trials for these candidates in close collaboration with our partners. We look forward to continuing our mission with our shareholders to accelerate the delivery of much needed new medicines for patients and their families worldwide."

Comment from Yusuke Matsumoto, SBI Group.:
"While the cost and time required for research and development of new drugs are increasing, Modulus has successfully created a business model from scratch for generating multiple clinical candidates with a small team of drug discovery simulation experts. We also believe that Modulus is well-positioned to expand its business globally and hope to support Modulus’ business expansion by making full use of SBI Group’s rich industry relationships."

Comment from Takahiro Mizumoto, UTokyo Innovation Platform Co., Ltd.:
"We are pleased to participate in this Series C, our second investment in the company. Modulus is a rare drug discovery venture in Japan, through a fabless, in silico drug discovery model, combined its top-notch science and management team. Through its strong ties to academia, Modulus is engaged in collaboration with the University of Tokyo in Cryo Electron Microscope as well as Tokyo Institute of Technology’s TSUBAME (a large-scale supercomputer), in addition to securing drug discovery seeds from other academic institutions. We believe that Modulus’ R&D approach can be a model case for future industry-academic collaborations. We are so thrilled to be part of Modulus’ mission in the discovery of new medicines and treatments for more patients in need."

On March 3, 2022 Aston Sci. (CEO: Hun Jung, Dr. Harry Hunwoo Shin) reported the completion of the Series C funding at a scale of USD 22.7 million in December last year (Press release, Aston Sci, MAR 3, 2022, View Source [SID1234609487]). Aston Sci. is a clinical-stage biopharmaceutical company based on a pipeline portfolio of innovative medicines with a focus on therapeutic cancer vaccines .

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With a compelling safety profile and treatment effects to prevent cancer recurrence after a standard treatment, therapeutic cancer vaccines are drawing attention from the high-risk patients with early-stage cancer in the global market.

In addition to the five existing investors including Timefolio Asset Management and Mirae Asset Venture Investment, four new investors participated in the Series C funding round. Including the Series C funding, Aston Sci. has attracted investment at a scale of USD 40 million in total. The raised fund will be used in global clinical development and drug discovery projects.

"The funding has been made possible as investors highly evaluated the clinical development expertise and execution capacity of Aston Sci. despite recent uncertainty toward biotech sector in investment markets," said Dr. Harry Shin. "Starting with the phase 2 randomized-controlled clinical trial (multinational study in the U.S., Australia, and Taiwan) for AST-301 expected to take place during the second quarter of this year, the value of each pipeline will continuously increase."

Aston Sci. has secured ten pipelines in preclinical and clinical stages including two clinical stage therapeutic cancer vaccines for which the study results were presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting and the 2021 SITC (Free SITC Whitepaper) Annual Meeting. The company plans to develop a stable new drug development portfolio by expanding its pipeline to 15 drugs in four clinical fields by 2030. In particular, for AST-301, a phase 2 RCT program is soon to commence in Australia, the U.S., and Taiwan, targeting HER2 +1/+2 breast cancer patients.

Aston Sci. decided to list on the KOSDAQ in order to facilitate its clinical and business development, and the company will prepare for its listing by applying for a technology evaluation in the second half of this year.

On March 3, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines, reported that BRUKINSA (zanubrutinib) has been approved by Health Canada for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy (Press release, BeiGene, MAR 3, 2022, View Source [SID1234609486]).

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"We will continue to work with physicians and their patients as part of our broad global clinical program for BRUKINSA, which includes 35 trials and more than 3,900 subjects across 28 markets."

"We are pleased that BRUKINSA is now approved in its third indication in Canada, R/R MZL, and this terrific milestone was made possible by the participating patients and investigators. This approval further supports our belief that BRUKINSA is a potentially best-in-class BTK inhibitor, with the MAGNOLIA trial results in R/R MZL providing additional evidence that the selective design of BRUKINSA can be translated into improved treatment outcomes," said Jane Huang, M.D., Chief Medical Officer of Hematology at BeiGene. "We will continue to work with physicians and their patients as part of our broad global clinical program for BRUKINSA, which includes 35 trials and more than 3,900 subjects across 28 markets."

"BRUKINSA is a highly selective next-generation BTK inhibitor designed to improve tolerability by minimizing off-target binding. In clinical trials, BRUKINSA achieved a high overall response rate among relapsed/refractory MZL patients and was generally well-tolerated. With this approval, Canadian patients with R/R MZL will have the option to receive BRUKINSA monotherapy as a treatment and a new hope for improved treatment outcomes," said Dr. Anthea Peters, a hematologist at the Cross Cancer Institute in Edmonton, Alberta.

"The approval of this medicine for the treatment of R/R MZL represents a new treatment option and is welcome news to Canadians living with this rare type of lymphoma," commented Antonella Rizza, Chief Executive Officer of Lymphoma Canada.

"We are delighted that BRUKINSA is now approved for patients with R/R MZL. Since our first approval 11 months ago, we have been expanding our organization in Canada and working to deliver on our commitment to create access to BRUKINSA for patients living with MCL, WM, and now MZL," added Peter Brenders, General Manager of Canada at BeiGene.

The Health Canada marketing approval for BRUKINSA in R/R MZL is based on efficacy results from two open-label, multicenter, single arm clinical trials. In the MAGNOLIA trial (NCT03846427) (n=68), which included previously treated patients with MZL who had received at least one prior anti-CD20-based therapy, 38% of patients had extranodal MZL, 38% had nodal MZL, 18% had splenic MZL and 6% patients had unknown subtype. In BGB-3111-AU-003 (NCT02343120) (n=20), which included patients with previously treated MZL, 45% had extranodal MZL, 25% had nodal MZL and 30% had splenic MZL. BRUKINSA Total Daily Dose was 320 mg daily, given as 160 mg twice daily or 320 mg once daily.

As assessed by Independent Review Committee per 2014 Lugano Classification, BRUKINSA achieved an overall response rate (ORR) of 68% (95% CI; 56, 79) in the MAGNOLIA trial and 80% (95% CI; 56, 94) in BGB-311-AU-003. In the MAGNOLIA trial, the median response time was 2.8 months (range: 1.7 to 11.1 months).

Serious treatment-emergent adverse events were reported in 35 (40%) patients. The most common serious adverse events (≥ 2% of patients) were pyrexia (8%), pneumonia (7%), influenza (2%), anemia (2%), diarrhea (2%), atrial fibrillation and flutter (2%) and fall (2%).

Of the 88 patients with MZL treated with BRUKINSA, five (6%) patients discontinued treatment due to adverse event. The adverse events leading to treatment discontinuation included two cases of pneumonia (due to COVID-19 pneumonia), one case each of pyrexia, myocardial infarction, and diarrhea. Two (2%) patients had a dose reduction due to adverse events. Death due to adverse events within 30 days of last dose occurred in three (3%) patients. The adverse events leading to death were: COVID-19 pneumonia in two patients (2%) and myocardial infarction in one patient (1%).

The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.

About myBeiGene Patient Support Program

The myBeiGene patient support program is designed to support patients, caregivers, and healthcare providers with easy access to BRUKINSA. It goes beyond financial assistance and provides practical and emotional support by connecting them to third-party resources that can address their individual needs. Oncology Nurse Advocates are available Monday through Friday from 8 a.m. to 5 p.m. Eastern Time at 1-833-234-4366.

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

To date, BRUKINSA has received more than 20 approvals covering more than 40 countries and regions, including the United States, China, the EU and Great Britain, Canada, Australia, and additional international markets. Currently, more than 40 additional regulatory submissions are in review around the world.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU and Great Britain, Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under FDA review, BeiGene and Novartis announced two new agreements in December 2021 granting Novartis an option to co-develop, manufacture, and commercialize BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development and adding five approved Novartis oncology products to the BeiGene product portfolio across designated regions of China.

On March 3, 2022 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, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided business updates (Press release, ADC Therapeutics, MAR 3, 2022, View Source [SID1234609485]).

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"We are encouraged by the progress of the ZYNLONTA launch and pleased with its differentiated product profile across the third-line patient spectrum, including patients with hard-to-treat disease, such as double hit/triple hit genetics, primary refractory and post CAR-T. In addition, data from our combination studies suggest that ZYNLONTA may be a valuable combination agent in earlier lines of therapy," said Chris Martin, DPhil, Chief Executive Officer of ADC Therapeutics. "Based on the latest data generated from our ZYNLONTA programs, we are focusing our efforts on the combination with rituximab in earlier lines of DLBCL, studies which offer the most rapid potential path to registration in areas of high unmet medical need. As we look ahead in 2022, we remain deeply committed to expanding the reach of ZYNLONTA to more patient types and geographies, advancing Cami towards a potential future BLA in Hodgkin lymphoma and advancing our solid tumor pipeline comprised of three clinical programs and two additional preclinical programs with near-term IND plans."

Recent Highlights and Developments

ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA generated net sales of $17.0 million in the fourth quarter of 2021 and $33.9 million in 2021 following the May launch.
The Phase 3 confirmatory trial of ZYNLONTA in combination with rituximab in second-line transplant-ineligible DLBCL patients (LOTIS-5) has cleared the safety lead-in and is now enrolling the randomized portion of the study. The combination of ZYNLONTA and rituximab is well tolerated, there are no new safety events, and the initial data suggest the agents are additive. The Company looks forward to sharing these data at a future meeting and believes this trial will support a supplemental Biologics License Application (BLA) in second-line transplant-ineligible patients.
The Company will focus on the second-line opportunity with the combination of ZYNLONTA and rituximab as the fastest potential route to a label in second-line therapy for DLBCL and will discontinue the Phase 2 LOTIS-3 trial of ZYNLONTA in combination with ibrutinib in third-line DLBCL and MCL.
In first-line DLBCL, the Company plans to initiate enrollment in the second half of 2022 for the LOTIS-9 study of ZYNLONTA in combination with rituximab in first-line unfit or frail DLBCL patients who are not eligible for R-CHOP. This is an important and meaningful subset of first-line patients. These patients have a significant unmet need, and the Company believes the ZYNLONTA profile combined with rituximab provides a potential advantage.
The Company intends to initiate the LOTIS-7 trial in the first half of 2022 to study ZYNLONTA in multiple additional combinations. Based on the plans to advance LOTIS-9 in unfit or frail first-line patients and LOTIS-7 for novel combinations, the Company will not pursue the LOTIS-8 dose-finding trial of ZYNLONTA in combination with R-CHOP in first-line DLBCL.
The comparator agent in the Phase 2 LOTIS-6 study, idelalisib, was recently withdrawn from the follicular lymphoma market. As such, the Company has voluntarily paused the study and will consult with its clinical advisors and the U.S. Food and Drug Administration (FDA) on the optimal path forward.
Cami (camidanlumab tesirine)

The 12-month patient follow-up in the pivotal Phase 2 trial of Cami in Hodgkin lymphoma has completed. The Company has submitted the data in an abstract for an upcoming oncology conference and plans to meet with the FDA for a pre-BLA filing meeting.
The Phase 1b solid tumor trial of Cami in combination with pembrolizumab continues to dose escalate and in parallel has initiated a dose expansion cohort.
ADCT-601 (Targeting AXL)

The Company plans to initiate the Phase 1b study of ADCT-601 in solid tumors in the first half of 2022. In January 2022, results of a preclinical study that aimed to validate the mode of action and evaluate the efficacy of ADCT-601 in vitro and in vivo were published in Molecular Cancer Therapeutics. The study showed that ADCT-601, targeting AXL, had potent and durable antitumor activity.
ADCT-212 (Targeting PSMA)

In February 2022, the Company disclosed a new preclinical program, ADCT-212, a second-generation ADC targeting prostate specific membrane antigen (PSMA), a validated target over-expressed in the majority of metastatic castration-resistant prostate cancer. The Company is completing preclinical studies to support an Investigational New Drug (IND) filing for ADCT-212.
Other Solid Tumor Programs

In February 2022, the Company held a solid tumor pipeline webcast highlighting its ADC platform and five solid tumor programs in clinical and preclinical development.
Corporate Update

Geographic Expansion: ADC Therapeutics continues to expand geographic access to ZYNLONTA:

In October 2021, the Company received validation of its Marketing Authorization Application (MAA) from the European Medicines Agency (EMA).
In January 2022, the Company entered into an exclusive license agreement with Mitsubishi Tanabe Pharma Corporation to develop and commercialize ZYNLONTA in Japan. The Company received an upfront payment of $30 million and is eligible to receive up to an additional $205 million in milestones if certain development and commercial events are achieved. The Company will also receive royalties ranging in percentage from the high teens to the low twenties based on net sales of the product in Japan.
Upcoming Expected Milestones

Hematology Franchise

ZYNLONTA

Continue to enroll the randomized portion of the LOTIS-5 confirmatory trial in combination with rituximab
Initiate the LOTIS-9 trial of ZYNLONTA + rituximab in 1L unfit/frail DLBCL patients in 2H 2022
Initiate the LOTIS-7 trial of ZYNLONTA in multiple combinations in NHL in 1H 2022
Overland ADCT BioPharma continues enrollment in the pivotal Phase 2 trial in China of ZYNLONTA in r/r DLBCL
Cami

Report topline results for the Phase 2 trial in HL in 1H 2022
Meet with FDA for pre-BLA meeting in 2H 2022
ADCT-602 (targeting CD22)

Continue to enroll the Phase 1 trial in acute lymphoblastic leukemia (ALL)
Solid Tumor Franchise

Cami (targeting CD25)

Continue to advance the Phase 1b solid tumor trial of Cami in combination with pembrolizumab
ADCT-901 (targeting KAAG1)

Continue to enroll the Phase 1 study in multiple solid tumors
ADCT-601 (targeting AXL)

Initiate the Phase 1b combination study in multiple solid tumors in 1H 2022
ADCT-701 (targeting DLK1)

Continue to work with the NCI for completion of preclinical studies to support an IND filing
ADCT-212 (targeting PSMA)

Continue completion of preclinical studies to support an IND filing
Fourth Quarter and Full Year 2021 Financial Results

Product Revenue

Product revenue (net) was $17.0 million for the quarter and $33.9 million for the full year ended December 31, 2021, compared to zero for the same quarter and full year in 2020. Net revenues are for U.S. sales of ZYNLONTA, which received accelerated approval from the FDA on April 23, 2021.

Cash and Cash Equivalents

Cash and cash equivalents were $466.5 million as of December 31, 2021, compared to $439.2 million as of December 31, 2020.

Research and Development (R&D) Expenses

R&D expenses were $42.5 million for the quarter and $158.0 million for the full year ended December 31, 2021, compared to $48.6 million for the same quarter in 2020 and $142.0 million for the full year in 2020. R&D expense decreased for the quarter ended December 31, 2021, as compared to the same quarter in 2020 as a result of lower CMC activity following the ZYNLONTA BLA submission and subsequent approval. R&D expenses increased for the year ended December 31, 2021, as compared to the same period in 2020 due to investments in programs evaluating the potential of ZYNLONTA in earlier lines of treatment and advancing the portfolio. As a result of these initiatives, employee headcount and share-based compensation expense increased.

Selling and Marketing (S&M) Expenses

S&M expenses were $18.6 million for the fourth quarter and $64.8 million for the full year ended December 31, 2021, as compared to $9.4 million for the same quarter in 2020 and $22.1 million for the full year in 2020. The increase in S&M expenses related to the launch of ZYNLONTA, including higher headcount and increased share-based compensation expense.

G&A Expenses

G&A expenses were $17.9 million for the quarter and $71.5 million for the year ended December 31, 2021, compared to $20.1 million for the same quarter in 2020 and $55.1 million for the full year in 2020. G&A expenses decreased for the quarter ended December 31, 2021, as compared to the same quarter in 2020 primarily due to a decrease in share-based compensation expense partially offset by higher costs of being a public company. G&A expenses for the year ended December 31, 2021, as compared to the same period in 2020 increased due to higher headcount to support the commercial launch, increased share‐based compensation expense and higher costs of being a public company.

Income Tax Benefit (Expense)

The Company recorded an income tax benefit of $22.0 million for the quarter and $21.5 million for the year ended December 31, 2021, compared to an income tax expense of $0.1 million for the same quarter in 2020 and $0.3 million for the full year in 2020. The income tax benefit in 2021 is the result of recording a deferred tax asset associated with R&D tax credits and temporary differences related to our U.S. subsidiary, which was recognized as a result of management’s revised projections of future taxable income based on the approval of ZYNLONTA and the commencement of commercial sales in the U.S.

Net Loss and Adjusted Net Loss

Net loss was $34.4 million, or a net loss of $0.45 per basic and diluted share, for the quarter ended December 31, 2021, and $230.0 million, or a net loss of $3.00 per basic and diluted share, for the full year 2021. This compares to a net loss of $55.9 million, or a net loss of $0.73 per basic and diluted share, for the same quarter in 2020 and a net loss of $246.3 million, or a net loss of $3.77 per basic and diluted share, for the full year 2020.

In addition to the items noted above, net loss for the quarter and year ended December 31, 2021, include a $18.6 million and $34.9 million non-cash gain, respectively, related to the changes in fair value of derivatives associated with the convertible loans under the Convertible Credit Facility with Deerfield, compared to an immaterial amount and a $45.4 million non-cash loss, respectively, for the same quarter and full year in 2020. The decrease in fair value for the year ended December 31, 2021, was driven by the decrease in the Company’s share price year-to-date, and the increase in fair value for the year ended December 31, 2020, was primarily driven by the increase in the Company’s share price from its initial public offering in May 2020. The quarter and year ended December 31, 2020, include a $24.5 million non-cash gain related to the Company’s contribution of intellectual property for its equity interest in the Overland ADCT BioPharma joint venture.

Adjusted net loss was $30.0 million, or an adjusted net loss of $0.39 per basic and diluted share, for the quarter ended December 31, 2021, and $186.1 million, or an adjusted net loss of $2.42 per basic and diluted share, for the full year 2021. This compares to $63.0 million, or an adjusted net loss of $0.82 per basic and diluted share, for the same quarter in 2020 and $176.1 million or an adjusted net loss of $2.69 per basic and diluted share, for the full year 2020. The decrease in adjusted net loss for the quarter ended December 31, 2021, as compared to the same period in 2020 was primarily due to the recognition of the income tax benefit described above. The increase in adjusted net loss for the year ended December 31, 2021, as compared to the same period in 2020 was primarily driven by the investment in the expanding clinical portfolio and the launch of ZYNLONTA, partially offset by the income tax benefit described above.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss fourth quarter and full year 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 conference ID 8189237. 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.