On August 2, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended June 30, 2022 and provided a corporate update (Press release, Syros Pharmaceuticals, AUG 9, 2022, View Source [SID1234617961]).

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"We are entering the second half of the year in a position of strength with multiple data readouts expected over the next 18 months and, following the anticipated closing of our previously announced merger with TYME Technologies and concurrent PIPE financing, we expect to have a robust balance sheet," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "The gross proceeds of approximately $190 million from these transactions, together with the amendment to our existing loan facility, are expected to extend our cash runway into 2025, at least one year beyond expected pivotal data from our ongoing SELECT-MDS-1 trial."

Dr. Simonian continued, "Today, we reported promising preliminary data from our ongoing dose confirmation trial of SY-2101, our novel oral form of arsenic trioxide. Based on the pharmacokinetic data available to date, SY-2101 achieved exposures comparable to IV arsenic trioxide and demonstrated high oral bioavailability. The totality of data with our oral arsenic trioxide continues to support a favorable safety and tolerability profile, giving us further confidence that SY-2101 has the potential to replace the standard-of-care for acute promyelocytic leukemia patients. Based on recent feedback received from the EMA, Syros plans to conduct a singular registration trial for SY-2101 that could support approval in both the United States and the European Union."

UPCOMING MILESTONES

Tamibarotene: Oral RARα agonist

Higher-Risk Myelodysplastic Syndrome (HR-MDS)

On track to report pivotal data from the SELECT-MDS-1 trial in newly diagnosed RARA-positive patients with HR-MDS in the fourth quarter of 2023 or the first quarter of 2024, with a potential new drug application (NDA) filing expected in 2024.
Acute Myelodysplastic Syndrome (AML)

On track to report safety and clinical activity data from the safety lead-in portion of the ongoing SELECT-AML-1 Phase 2 trial in RARA-positive patients with newly diagnosed unfit AML in the second half of 2022.
Expect to initiate the randomized portion of the SELECT-AML-1 Phase 2 trial in an additional eighty patients evaluating the triplet regimen of tamibarotene, venetoclax and azacitidine compared to venetoclax and azacitidine with data expected in 2023 or 2024.
SY-2101: Oral arsenic trioxide (ATO)

Expect to initiate the Phase 3 trial of SY-2101 for the treatment of acute promyelocytic leukemia (APL) in the second half of 2023.
SY-5609: Oral selective CDK7 inhibitor

On track to report safety and clinical activity data from the safety lead-in portion of the ongoing Phase 1 trial evaluating SY-5609 in combination with chemotherapy in relapsed/refractory metastatic pancreatic cancer in the second half of 2022.
RECENT PIPELINE HIGHLIGHTS

Today, Syros announced promising preliminary data from newly diagnosed APL patients enrolled to date in the dose confirmation trial of SY-2101. This is the first cross-over data directly comparing the pharmacokinetics (PK) of SY-2101 to the approved IV dose ATO. SY-2101 administered at 15 mg achieved comparable PK (AUC and Cmax) exposures to IV ATO administered at 0.15 mg/kg. Additionally, SY-2101 showed high oral bioavailability of approximately 80% and continues to support a favorable tolerability profile.
In July, Syros received European Medicines Agency (EMA)/ Committee for Medicinal Products for Human Use (CHMP) scientific advice on the SY-2101 Phase 3 trial design in front line APL. The feedback informs Syros’ plan for a singular registration trial for SY-2101 that could support approval in both the United States (US) and the European Union (EU).
In July, the EMA issued a positive opinion on the Company’s application for orphan drug designation for tamibarotene for the treatment of MDS. The EMA’s orphan designation is available to companies developing treatments for life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 persons in the EU. Medicines that meet the EMA’s orphan designation criteria qualify for financial and regulatory incentives, including a 10-year period of marketing exclusivity in the EU after product approval, protocol assistance from the EMA at reduced fees during the product development phase and access to centralized marketing authorization.
In June, Syros announced that based on results from over 175 MDS patients, the company now estimates that approximately 50% of patients with MDS are RARA-positive, as compared to the previously estimated 30%.
Roche is now actively enrolling patients in the arm of its ongoing Phase 1/1b INTRINISIC trial evaluating SY-5609 in combination with atezolizumab, its PD-L1 inhibitor, in BRAF-mutant colorectal cancer patients. Under the terms of Syros’ agreement with Roche, Roche is the sponsor of the trial and Syros is supplying SY-5609.
In July, Syros advanced its oral, potent, and selective CDK12 inhibitor, SY-12882, to development candidate. Preclinical data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrated that selective CDK12 inhibition resulted in strong anti-tumor activity as a single agent as well as in combination with a DNA damaging agent and in combination with a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor in models of breast, lung, and ovarian cancer.
CORPORATE

In July, Syros announced that it plans to raise approximately $190 million through a merger with TYME Technologies and an oversubscribed private investment in public equity (PIPE) financing. The $130M PIPE was led by a life sciences-focused investment fund, with participation from new and existing investors, including Syros co-founder and founding investor Flagship Pioneering, as well as Avidity Partners, Deep Track Capital, Bain Capital Life Sciences, Invus, Samsara BioCapital, Adage Capital Partners LP, Ally Bridge Group and Cowen Healthcare Investments. The transactions are expected to close concurrently with each other in the second half of 2022, subject to approval by the stockholders of Syros and TYME and the satisfaction of other customary closing conditions.
Concurrently, Syros amended its senior secured loan facility with Oxford Finance LLC (Oxford) to, subject to certain conditions, extend the interest-only payment period to March 1, 2024 (and, upon the achievement of certain milestones, September 1, 2024), and extend the maturity date to February 1, 2026 (and, upon the achievement of certain milestones, August 1, 2026).
Also in July, Syros announced that it is seeking partnerships for all its wholly owned discovery programs. The Company will continue to execute on its existing collaborations with Incyte Corporation (Incyte) and Global Blood Therapeutics (GBT), for which its research efforts are fully funded, as provided in each agreement.
Second Quarter 2022 Financial Results

Revenues were $6.3 million for the second quarter of 2022, consisting of $5.7 million in revenue recognized under Syros’ collaboration with GBT and $0.6 million recognized under its collaboration with Incyte. Syros recognized $5.2 million in revenue in the second quarter of 2021, consisting of $3.3 million in revenue recognized under its collaboration with GBT and $1.9 million recognized under its collaboration with Incyte.
Research and development expenses were $33.1 million for the second quarter of 2022, as compared to $25.8 million for the second quarter of 2021. This increase was primarily due to the increase in costs associated with the continued advancement of our clinical and preclinical programs and employee-related expenses.
General and administrative (G&A) expenses were $6.9 million for the second quarter of 2022, as compared to $5.5 million for the second quarter of 2021. This increase was primarily due to an increase in employee-related expenses.
For the second quarter of 2022, Syros reported a net loss of $34.5 million, or $0.54 per share, compared to a net loss of $22.5 million, or $0.36 per share, for the same period in 2021.
Cash and Financial Guidance

Cash, cash equivalents and marketable securities as of June 30, 2022 were $86.3 million, as compared with $143.4 million on December 31, 2021. Based on Syros’s current operating plan and without giving effect to the merger with TYME, the PIPE financing and the loan amendment with Oxford, the completion of which cannot be assured, Syros anticipates that its cash, cash equivalents and marketable securities of $86.3 million as of June 30, 2022 will allow it to meet its liquidity requirements into the second quarter of 2023.

If Syros completes the merger with TYME and the PIPE financing and gives effect to certain provisions of the loan amendment with Oxford related to such closings (which is expected to occur in the second half of 2022), Syros anticipates having approximately $240 million in cash and other capital resources (after transaction expenses), which it believes will be sufficient to fund its planned operating expenses and capital expenditure requirements into 2025.

Conference Call and Webcast

Syros will host a conference call today at 8:30 a.m. ET to discuss these second quarter 2022 financial results and provide a corporate update.

To access the live conference call, please dial (833) 636-1323 (domestic) or (412) 902-4279 (international) and refer to the "Syros Pharmaceuticals Conference Call." A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On August 9, 2022 Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, reported results from the myCare-203A study, which demonstrate that the Cellworks Biosimulation Platform and Singula Therapy Response Index (TRI) was strongly predictive of Overall Survival (OS) for non-small cell lung cancer (NSCLC) patients and can provide personalized therapy decision guidance (Press release, Cellworks, AUG 9, 2022, View Source [SID1234617960]). In the study, Singula Therapy Response Index (TRI) provided patient-specific scores that demonstrated predictive value of OS beyond NCCN-guideline genomic biomarkers, physician-prescribed treatments and standard clinical factors such as the patient’s age and sex.

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The results from the myCare-203A clinical study were featured in a poster presentation at the IASLC 2022 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer and held in Vienna, Austria from August 6-9, 2022.

"The current population-based cancer therapy guidelines do not consider the full biological complexity of an individual patient’s disease and therefore may limit the patient’s duration of therapy response and overall effectiveness of the treatment," said Dr. Mark Klein, Staff Physician, Hematology/Oncology Section, Minneapolis VA; Associate Professor, Division of Hematology, Oncology and Transplantation, University of Minnesota; and Co-Principal Investigator of the myCare-203A clinical study. "In contrast to population-based therapy guidelines, the Cellworks Biosimulation Platform produces personalized therapy predictions for each NSCLC patient based on a patient-specific multi-omic disease model. The myCare-203A study found that the personalized approach of Cellworks Singula TRI produces a more precise therapeutic decision guide for patients with NSCLC."

"There are multiple approved drugs for treating NSCLC, which makes selecting the most efficacious treatment for each patient more complicated," said Dr. Apar Kishor Ganti, Staff Physician, VA Nebraska Western Iowa Health Care System; Professor in the Department of Internal Medicine, Division of Oncology/Hematology, at the University of Nebraska Medical Center; and Co-Principal Investigator of the myCare-203A clinical study. "The myCare-203A study shows us that the Cellworks Biosimulation Platform and Singula TRI can streamline the treatment decision-making process and improve NSCLC patient outcomes through personalized therapy response predictions."

The Cellworks Biosimulation Platform simulates how a patient’s personalized genomic disease model will respond to therapies prior to treatment. The platform is powered by Cellworks groundbreaking Computational Omics Biology Model (CBM), a network of 7,000+ human genes, 30,000+ molecular species and 100+ signaling pathways. As part of the biosimulation process, personalized disease models are created for each patient using their cytogenetic and molecular data as input to the Cellworks CBM. The Cellworks platform analyzes the impact of specific therapies on the patient’s personalized disease model and generates a Singula biosimulation report with Therapy Response Index (TRI) scores from 0 to 100 that predict low to high therapeutic benefit.

myCare-203A Clinical Study

Background
In this study, the Cellworks Biosimulation Platform and Computational Omics Biology Model (CBM) was used to prospectively generate Singula Therapy Response Index (TRI) scores for a retrospective cohort of 453 NSCLC patients aged 39-87 (22 female, 431 male) from Veterans Affairs facilities, who were treated with physician-prescribed therapies.

Methods
Cellworks Singula TRI scores were generated for physician-prescribed therapies and 109 alternate therapies for each patient, enabling selection of optimal therapies with estimates of improvements in median OS compared to standard care. Multivariate Cox Proportional Hazards regression models were used to test the hypothesis that Cellworks Singula TRI provides predictive value of OS above and beyond physician-prescribed treatment, NCCN-guideline genomic biomarkers, patient age and patient sex.

Results and Conclusions
Multivariate analyses demonstrated that Cellworks Singula TRI is a significant predictor of OS and provided predictive value of OS above and beyond physician-prescribed treatment, NCCN-guideline genomic biomarkers, patient age and patient sex. These results show that physicians can use Cellworks Singula TRI scores to more precisely guide therapeutic decisions for individual patients with NSCLC.

On August 9, 2022 BostonGene reported the online publication of the manuscript, "Precise reconstruction of the tumor microenvironment using bulk RNA-seq and a unique machine learning algorithm trained on artificial transcriptomes" in Cancer Cell, a premier peer-reviewed scientific journal that publishes high impact results in cancer research and oncology (Press release, BostonGene, AUG 9, 2022, View Source [SID1234617959]). The study demonstrated the ability of the BostonGene-developed unique and robust machine learning (ML) algorithm named Kassandra to digitally reconstruct the tissue tumor microenvironment (TME) and blood cellular composition, identifying over 50 unique cell populations in total from RNA-seq derived from both archival and fresh tissues. These results indicate that cellular deconvolution can be utilized in future clinical applications to predict blood and tissue microenvironment composition, a critical factor in cancer pathogenesis, clinical outcome, and therapeutic resistance.

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Kassandra was trained on a broad collection of > 9,400 tissue and blood-sorted cell RNA profiles incorporated into millions of artificial transcriptomes for this research study. To increase the stability and robustness of BostonGene’s decision-tree ML deconvolution algorithm, bioinformatic correction for technical and biological variability, aberrant cancer cell expression inclusion, and accurate quantification and normalization of transcript expression were applied. Results of the study showed that Kassandra recognizes 51 unique subpopulations and accurately deconvolves less well-characterized stromal and immune elements of prospectively collected lung and kidney cancer tumors. Kassandra-based TME reconstruction found the presence of PD1-positive CD8+ T cells strongly correlates with immunotherapy response and PD-L1 protein levels detected by immunohistochemistry, the established immunotherapy response biomarker, indicating that in the future RNA-seq-based cellular deconvolution could support oncology clinical decision-making.

"Our findings demonstrate the importance of cellular deconvolution based on RNA-seq to accurately understand the composition and activity of the tumor and the microenvironment to improve treatment outcomes," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "We look forward to further developing the Kassandra algorithm and showing its clinical applicability in precision oncology.

On August 9, 2022 Fore Biotherapeutics, a precision oncology company developing treatments for patients with genetically defined cancers whose current treatment options are limited, reported that data from the ongoing Phase 1/2a study of lead asset, FORE8394, will be presented in the Developmental Therapeutics poster session at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper) taking place in Paris, France, September 9-13, 2022 (Press release, Fore Biotherapeutics, AUG 9, 2022, View Source [SID1234617958]).

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The Phase 1/2a open-label study is assessing FORE8394, a next-generation BRAF inhibitor, in patients with advanced solid and CNS tumors with activating BRAF alterations. The poster presentation will report interim analysis in adults (≥18 years) with V600+ advanced solid & central nervous system tumors, including patients who have not previously received BRAF targeted treatment. FORE8394 is a novel, differentiated BRAF inhibitor that uniquely targets Class 1 (V600) and Class 2 alterations, including fusions, and does not induce paradoxical activation of the RAF/MEK/ERK pathway, a limitation of the current standard of care.

Details for the presentation are as follows:

Title: Efficacy of BRAF Inhibitor FORE8394 in BRAF V600+ Patients
Abstract #: 2098
Presentation #: 466P
Presenter: Eric J. Sherman, Memorial Sloan Kettering Cancer Center
Date: Monday, September 12, 2022
Time: 12:00 -13:00 CEST

About FORE8394
FORE8394 is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. It was designed to target a wide range of BRAF mutations while sparing wild type forms of RAF. Preclinical studies and clinical trials have shown that its unique mechanism of action effectively inhibits not only the constitutively active BRAFV600 monomers targeted by first-generation RAF inhibitors, but also disrupts constitutively active dimeric BRAF class II mutants, fusions, splice variants and others. Unlike first-generation RAF inhibitors, FORE8394 does not induce paradoxical activation of the RAF/MEK/ERK pathway. As a "paradox breaker," FORE8394 could therefore treat acquired resistance to current RAF inhibitors, and, more generally, yield improved safety and more durable efficacy than first-generation RAF inhibitors

On August 9, 2022 ADC Therapeutics SA (NYSE: ADCT) reported financial results for the second quarter ended June 30, 2022 and provided business updates (Press release, ADC Therapeutics, AUG 9, 2022, View Source [SID1234617957]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"The ZYNLONTA launch is advancing steadily as we continue to increase awareness and advocacy. There is significant opportunity ahead and we have a focused plan in place to achieve continued growth in the coming quarters," commented Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "Our pipeline of hematology and solid tumor programs is progressing well with impressive Cami Phase 2 data in Hodgkin lymphoma presented at the EHA (Free EHA Whitepaper) Congress in June. Our recent license agreement with Sobi in Europe gives us worldwide access for ZYNLONTA. We have a strong cash runway extending into early 2025 which makes us well-positioned to execute on our key objectives."

Recent Highlights and Developments

Corporate Update

Announced an exclusive license agreement with Swedish Orphan Biovitrum AB (Sobi) for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications outside of the United States, greater China, Singapore and Japan.
Appointed David Gilman as Chief Business & Strategy Officer.
Elected veteran oncology drug developer Jean-Pierre Bizzari, MD, and CEO Ameet Mallik to the Company’s Board of Directors.
Hematology Franchise

ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA generated net sales of $17.3 million in the second quarter of 2022.
Initiated LOTIS-9, the Phase 2 clinical trial of ZYNLONTA in combination with rituximab in unfit or frail first-line diffuse large B-cell lymphoma (DLBCL) patients.
Initiated LOTIS-7, the Phase 1b clinical trial of ZYNLONTA in combination with other anti-cancer agents.
Terminated LOTIS-6, the Phase 2 clinical trial of ZYNLONTA in patients with relapsed or refractory follicular lymphoma.
The Overland ADCT BioPharma joint venture enrolled the first patient in China in the global LOTIS-5 confirmatory Phase 3 clinical trial of Lonca and rituximab in second-line or later transplant ineligible DLBCL patients.
Overland ADCT Biopharma completed enrollment of the single-agent bridging study in third-line+ DLBCL, which forms the basis for submission of a marketing application in China.
Cami (camidanlumab tesirine) in Hodgkin lymphoma

Released results from the Phase 2 Hodgkin lymphoma (HL) registrational trial at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress in June. These results showed an overall response rate (ORR) of 70%, a complete response (CR) rate of 33% and a median duration of response (DOR) of 13.7 months. Safety data confirmed the manageable tolerability of Cami in these patients.
Solid Tumor Franchise

ADCT-601 (targeting AXL)

Initiated the Phase 1b combination trial in multiple solid tumors.
Upcoming Expected Milestones

Hematology Franchise

ZYNLONTA

Present LOTIS-5 safety lead-in data at an upcoming medical meeting in 2H 2022
Receive a regulatory decision for third-line DLBCL from the Committee for Medicinal Products for Human Use (CHMP), a committee of the European Medicines Agency (EMA), by 1Q 2023
Cami

Meet with the U.S. Food and Drug Administration (FDA) for HL pre-Biologics License Application (BLA) meeting in September 2022
Complete BLA submission for HL to the FDA in 2H 2023
Solid Tumor Franchise

Cami (targeting CD25)

Preliminary results of safety and clinical activity are anticipated in 2023 for the Phase 1b solid tumor trial of Cami in combination with pembrolizumab
ADCT-901 (targeting KAAG1)

Preliminary results of safety and tumor response for the Phase 1 dose escalation trial in multiple solid tumors are anticipated in 2023
Second Quarter Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $376.8 million as of June 30, 2022, compared to $466.5 million as of December 31, 2021.

Product Revenue

Product revenue (net) was $17.3 million for the quarter, compared to $3.8 million for the same quarter in 2021. Net revenues are for U.S. sales of ZYNLONTA, which received accelerated approval from the FDA on April 23, 2021.

Cost of product sales

Cost of product sales was $2.3 million for the quarter, compared to $0.1 million for the same quarter in 2021, an increase of $2.1 million associated with $1.9 million of impairment charges primarily related to the manufacturing of antibodies that was not within the Company’s specifications. The specification issues did not, and are not expected to, impact the Company’s ability to supply commercial product. In addition, cost of product sales increased due to a full second quarter of sales activity in 2022 as compared to the same period in 2021 due to the commencement of ZYNLONTA sales in May 2021.

Research and Development (R&D) Expenses

R&D expenses were $48.5 million for the quarter ended June 30, 2022, compared to $39.5 million for the same quarter in 2021. As a result of FDA approval of ZYNLONTA in April 2021, the Company reversed $6.8 million of previously recorded impairment charges during the three months ended June 30, 2021, relating to inventory costs incurred for the manufacture of product prior to FDA approval. In addition, R&D expenses increased due to clinical activities to expand ZYNLONTA’s potential market opportunities in earlier lines of therapy and advance the Company’s portfolio of solid tumor programs.

Selling and Marketing (S&M) Expenses

S&M expenses were $17.7 million for the quarter ended June 30, 2022, as compared to $15.2 million for the same quarter in 2021. The increase in S&M expenses is related to the ongoing launch of ZYNLONTA.

G&A Expenses

G&A expenses were $18.2 million for the quarter ended June 30, 2022, compared to $19.4 million for the same quarter in 2021. G&A expenses decreased primarily due to lower share-based compensation expense.

Net Loss and Adjusted Net Loss

Net loss was $64.4 million, or a net loss of $0.84 per basic and diluted share, for the quarter ended June 30, 2022. This compares to a net loss of $72.6 million, or a net loss of $0.95 per basic and diluted share, for the same quarter in 2021. The decrease in net loss for the quarter ended June 30, 2022, as compared to the same period in 2021, was primarily due to higher product revenue, partially offset by the increase in cost of product sales, R&D and S&M expenses. In addition, net loss decreased for the second quarter of 2022 as a result of income arising from changes in the fair value of derivatives associated with our Deerfield Facility Agreement, partially offset by higher interest expense associated with the deferred obligation with Healthcare Royalty Partners.

Adjusted net loss was $56.3 million, or an adjusted net loss of $0.73 per basic and diluted share, for the quarter ended June 30, 2022. This compares to $53.7 million, or an adjusted net loss of $0.70 per basic and diluted share, for the same quarter in 2021.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss second quarter 2022 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at www.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.