On November 12, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it will create a new Oncology Business Unit, effective April 1, 2021, aligning U.S and European oncology businesses, global oncology functions of marketing, market access and pricing, medical affairs as well as alliance management under one team singularly devoted to people with cancer (Press release, Daiichi Sankyo, NOV 12, 2020, https://www.businesswire.com/news/home/20201112005188/en/Daiichi-Sankyo-Creates-New-Business-Unit-to-Unify-Major-Oncology-Markets-into-One-Streamlined-Organization-Dedicated-to-Patients-with-Cancer [SID1234570829]).

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Ken Keller, currently leading the U.S. Business and CEO of the Company’s U.S. affiliates Daiichi Sankyo, Inc. and American Regent, Inc., will lead this new team as Head of the Oncology Business Unit, effective, April 1, 2021, and will remain President and CEO of Daiichi Sankyo, Inc. Paul Diolosa, currently Senior Vice President of Operations of American Regent, Inc., will succeed Mr. Keller as President and CEO of American Regent, Inc. as of April 1, 2021.

As oncology business growth will be driven primarily by the U.S. and Europe in the near-term, the Company will launch the Oncology Business Unit by combining these two markets.

"Daiichi Sankyo will accelerate one of the boldest strategies we have embarked upon – to realize our 2025 Vision "Global Pharma Innovator with competitive advantage in Oncology," said Sunao Manabe, President and CEO, Daiichi Sankyo Company, Ltd. "With our oncology portfolio putting this vision within reach, we must evolve our global management structure into one that will usher us into a successful long-term business dedicated to improving patients’ lives."

"The Oncology Business Unit will allow us to bring an unprecedented focus to respond to the rapid changes we see in standards of care, treatment and diagnoses patterns, and payer dynamics from both perspectives of business and science," said Ken Keller.

Ken Keller, who joined Daiichi Sankyo in 2014, has more than 30 years of experience in the pharmaceutical industry in general management, commercial, international and joint venture leadership, as well as chief operating officer experience in several therapeutic areas, including oncology, bone health, rheumatology, dermatology and primary care. Prior to joining the Daiichi Sankyo Group, Mr. Keller was the president and chief operating officer at Spectrum Pharmaceuticals and prior to that spent 21 years at Amgen. At Amgen, Keller was Vice President and General Manager leading a number of highly successful, high profile business units in the United States. Keller held roles of advancing responsibilities including Vice President of Oncology marketing and has significant international experience, having been Amgen’s Managing Director, UK and Ireland. Keller started his career as a professional sales representative.

On November 12, 2020 Australian clinical-stage drug development company Noxopharm (ASX: NOX) reported it has joined with Bristol Myers Squibb (NYSE: BMY) in an Australian pilot study investigating the ability of Noxopharm’s immunotherapy drug candidate, Veyonda, to overcome resistance to Bristol Myers Squibb’s nivolumab (Opdivo) in the treatment of cancer (Press release, Noxopharm, NOV 12, 2020, View Source [SID1234570828]).

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Veyonda is a first-in-class sphingosine-1-phosphate inhibitor with high selectivity for cancer cells. This mechanism of action yields a range of immunotherapeutic effects including restoration of immune function in tumors, commonly referred to as converting tumors from cold to hot.

The study, called IONIC-1, will investigate the ability of Veyonda to sensitize tumors to the PD-1 inhibiting actions of Opdivo. Approximately 30 cancer patients (e.g., melanoma, lung, and bladder cancers) will be involved, including those who have progressed on Opdivo, as well as Opdivo-naive patients (e.g., breast, ovarian, prostate cancers and sarcoma). It is anticipated that the first patients will be recruited early in the new year.

Immune checkpoint inhibitors such as Opdivo have revolutionized the treatment of some cancers with what can be dramatic, lifesaving benefits. However, most cancer types have proven to be resistant. Research points to a key limiting factor — the lack of competent immune function within cancer — with individual tumors actively expelling immune cells. Restoring that immune function is a major current goal within the pharmaceutical industry.

"I’m excited to be working with Noxopharm and Bristol Myers Squibb on this study," said principal investigator professor Paul De Souza, dean of medicine at the University of Wollongong. "Checkpoint inhibitors have made a tremendous difference to some patients with advanced cancer. If we can increase the number of patients that respond through the addition of Veyonda to their treatment regimen, we will make a significant impact — not only to those individuals, but also on the oncology landscape."

The checkpoint inhibitor market is a multi-billion-dollar market with rapid year-on-year growth, currently dominated by two major global pharmaceutical companies, one of which is Bristol Myers Squibb.

On November 12, 2020 IMV Inc. (the "Company" or "IMV") (TSX: IMV; NASDAQ: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, reported financial results for the third quarter ended September 30, 2020 and provides an update on its clinical and operational progress (Press release, IMV, NOV 12, 2020, View Source [SID1234570827]).

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"Biomarkers predictive of responses can be game-changing in the development of new treatments for cancer. We are extremely happy to share our success this week in finding a potential predictive biomarker that is associated with a very high level of clinical efficacy in patients with relapsed/refractory DLBCL. The PD-L1 biomarker is well recognized and already approved for multiple cancer indications and this finding brings us closer to an accelerated path to market for DPX-Survivac in this high unmet medical need patient population."

"In addition to this significant milestone, we continued to make progress across our pipeline and corporate development objectives steadily advancing development in other cancer indications as well as our vaccine against COVID-19," said Fred Ors, Chief Executive Officer at IMV.

Third quarter 2020 and Recent Operational Highlights:

DPX-Survivac

Phase 2 SPiReL Study in Relapsed / Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL)

SPiReL is an investigator-initiated Phase 2 study evaluating DPX-Survivac/CPA in combination with Keytruda (pembrolizumab) in r/r DLBCL. The study is led by Dr. Neil Berinstein, MD, FFCP©, ABIM, hematologist-oncologist at the Odette Cancer Centre at Sunnybrook Health Sciences Centre in Toronto, Ontario.

As of October 30, 2020, 24 patients have been enrolled across six clinical sites in Canada. As reported in May 2020, the study has already met its primary efficacy endpoint.

On November 11, 2020, Dr. Berinstein delivered a poster presentation at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting. As of the data cut-off date of this presentation, 18 pre-treatment samples from 18 patients enrolled in the SPiReL study were available for biomarker analysis and thirty-nine percent (7/18) of these patients had pre-treatment tumors that were classified as PD-L1 positive.

Key findings for this population include:

6/7 subjects demonstrated a partial response (PR) or complete response (CR), resulting in an Objective Response Rate (ORR) of 86% (3 CR and 3 PR) and no clinical response (PR or CR) has been observed in the PD-L1 negative population (n=11); and
Observed 100% Disease Control Rate (DCR) defined as Stable Disease, PR or CR.
On the strength of these results, IMV is working on the design of the next clinical study in r/r DLBCL. The Company plans to engage with the U.S. Food and Drug Administration (FDA) as soon as possible to identify the best path toward registration.

Phase 2 DeCidE1 Study in Advanced Recurrent Ovarian Cancer

DeCidE1 is a Phase 2 multicenter, randomized, open-label study to evaluate the safety and efficacy of DPX-Survivac/CPA. This Phase 2 arm enrolled 22 patients with recurrent, advanced platinum-sensitive and/or resistant ovarian cancer.

IMV intends to present top line data during a virtual key opinion leader meeting on December 3, 2020 at 8:00 am ET.

Phase 2 Basket Trial in Multiple Advanced Metastatic Solid Tumors

The Basket Trial is an open label, multi-center Phase 2 study, evaluating the safety and efficacy of DPX-Survivac/CPA in combination with Keytruda across five cohorts of patients with bladder cancer, liver cancer (hepatocellular carcinoma), ovarian cancer (with and without CPA), NSCLC and tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

As of October 30, 2020, a total of 106 patients out of the planned 184 patients have been enrolled across all five indications at 19 clinical sites in Canada and the US.

As noted previously, the COVID-19 pandemic has impacted data collection and verification from this study. The Company intends to report results in the first quarter of 2021 to coincide with seasonal healthcare industry conferences.

DPX-COVID-19

In October 2020, IMV announced that in consultation with Health Canada, it intends to combine its original Phase 1 and 2 studies into a single trial with the potential to accelerate the clinical development and the timeline of the overall project. The design of this study will incorporate the same two-age strata cohorts (18-55 years old and over 55 years old) as originally planned.

Subject to the approval of Health Canada and after the completion and submission of the preclinical safety, GLP toxicology and challenge studies, the Phase 1/2 trial is expected to be approved and initiated before the end of 2020.

Additional funding and Increased Manufacturing Capacity

In October 2020, IMV announced that the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) will provide advisory services and up to $5.4 million in funding to support the continuation of clinical trials for its DPX-COVID-19 vaccine candidate. This funding is milestone based and will be dependent upon the achievement of certain objectives. To date, IMV has secured more than $10 million to fund its DPX-COVID-19 development efforts and other non-dilutive funding requests are ongoing.

To increase its current manufacturing capacity, IMV has entered a collaboration with a global manufacturing partner and initiated transfer and scale-up activities of DPX-COVID-19. This collaboration has the potential to bring two additional production sites in India and Europe with capacity to produce several hundred million doses of DPX-COVID-19.

Corporate Update

On November 10, 2020, Andrew Hall joined IMV as Chief Business Officer. Mr. Hall was previously Executive Director, Business Development and Global Alliances at Celgene.

In July 2020, Michael P. Bailey was appointed to the board of directors. Mr. Bailey currently serves as President and Chief Executive Officer and a member of the board of directors at AVEO Oncology.

Upcoming Milestones

Over the course of upcoming quarters, the Company expects to deliver the following milestones:

DPX-Survivac
Additional Phase 2 clinical results from the DLBCL combination at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting to be held virtually on December 6, 2020
Top line Phase 2 clinical results from the ovarian cancer trial on December 3, 2020
Updated Phase 2 clinical results from the basket trial in Q1 2021
DPX-COVID-19
Initiation of Phase 1/2 clinical trial with DPX-COVID-19 in 2020
Preliminary Phase 1/2 results in Q1 2021
Overview of Third quarter 2020 Financial Results

On September 30, 2020, the Company had cash and cash equivalents of $54,700,000 and working capital of $55,875,000, compared with $14,066,000 and $13,199,000, respectively at December 31, 2019. This primarily reflects proceeds from the $25,100,000 private placement completed on May 7th, the 6,841,773 common shares issued for gross proceeds of US$30 million (CAD$40.8 million) under its March and June At-The-Market facilities and $2,276,000 from the exercise of 611,888 common share warrants. Based on its current operating plan, IMV expects its current cash position will be sufficient to fund operations for more than the next 12 months.

Research and development expenses increased by $889,000 during the quarter ended September 30, 2020, compared to Q3 2019. These increases are mainly due to pre-clinical development for DPX-COVID-19, which is offset by an increase in government assistance, and to a lesser extent, also attributable to personnel costs due to an increase in headcount. The increase in research and development expenses is partly offset by a decrease in travel, DPX-SurMAGE preclinical development and costs related to the DeCidE1 Phase 2 study of DPX-Survivac/CPA, in patients with advanced recurrent ovarian cancer.

General and administrative expenses increased by $1,064,000 for the quarter ended September 30, 2020 compared to Q3 2019. This increase is explained by an increase in insurance premium and to a lesser extent is also attributable to an increase in foreign exchange loss. This increase is partly offset by a decrease of $223,000 in legal and professional fees and a decrease of $170,000 in travel due to COVID-19 travel restrictions.

The net loss and comprehensive loss of $8,327,000 ($0.13 per share) for the quarter ended September 30, 2020 was $431,000 higher than the net loss and comprehensive loss of $7,896,000 ($0.16 per share) for the quarter ended September 30, 2019.

For the nine-month period ended September 30, 2020, the net loss and comprehensive loss of $25,259,000 was $6,369,000 higher than the net loss and comprehensive loss for the nine-month period ended September 30, 2019. This relates mainly to a $5,161,000 increase in R&D expenses and a $3,000,000 increase in general and administrative expenses partly compensated by a $1,556,000 increase in government assistance mainly towards COVID-19 vaccine development.

For the nine months ended September 30, 2020, IMV’s cash burn rate, defined as net loss for the period adjusted for operations not involving cash (interest on lease obligation, depreciation, accretion of long-term debt, stock-based compensation and DSU compensation), was $23,566,000.

As of November 11, 2020, the number of issued and outstanding common shares was 67,093,547 and a total of 4,490,791 stock options, deferred share units and warrants were outstanding.

The Company’s unaudited interim condensed consolidated results of operations, financial condition and cash flows for the quarter ended September 30, 2020 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.

Conference Call and Webcast Information

Management will host a conference call and webcast today, November 12, 2020, at 8:00 a.m. ET. Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID# 6146758. Other interested parties will be able to access the live audio webcast at this link.

On November 12, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the presentation of data on two of its skin cancer gene expression profile tests during the 57th Meeting of The American Society of Dermatopathology (ASDP) (Press release, Castle Biosciences, NOV 12, 2020, View Source [SID1234570826]).

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DecisionDx-Melanoma:

"Identifying predictors of sentinel lymph node metastasis in cutaneous melanoma patients using molecular and clinicopathologic high-risk features" was presented by Federico Monzon, M.D.

DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors.

"DecisionDx-Melanoma uses primary tumor biology to delineate patient metastatic risk, including the risk of SLN metastasis," said Monzon. "In this study, among all features evaluated, DecisionDx-Melanoma was the most significant factor in predicting rates of SLN positivity, justifying a role for the test alongside other commonly used features in considering the sentinel lymph node biopsy surgical procedure."

Study methods and findings:

Authors modeled decision trees using the statistical R package for a cohort of 3,093 patients with cutaneous melanoma to determine which molecular and clinicopathologic features could best stratify the risk of patients’ receiving a positive result from a sentinel lymph node biopsy (SLNB).
DecisionDx-Melanoma was the most significant factor in distinguishing between high and low SLN-positivity rates (p<0.001).
Patients with a Class 2 (high-risk) DecisionDx-Melanoma result under age 75 or with a very high mitotic rate (>10/mm2) had the highest SLN-positivity rates (>20%).
Conversely, patients with a Class 1A result over age 47 with tumors with no mitoses and those age 47 or younger with a Breslow thickness of 0.85mm or less had the lowest positivity rates (<5%), indicating they could potentially forego SLNB.
Patients of all ages and Breslow thicknesses with a Class 2 result had a greater than 10% risk of SLN positivity, indicating that a Class 2 DecisionDx-Melanoma result can be considered a high-risk factor when considering the SLNB procedure for individual patients.
DecisionDx DiffDx-Melanoma:

"Development and validation of a diagnostic gene expression profile test for ambiguous or difficult-to-diagnose pigmented skin lesions" was presented by Sarah Estrada, M.D., FCAP.

DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions.

"Approximately 300,000 melanocytic lesions biopsied each year cannot be confidently identified as either malignant or benign, so the nature of these lesions remains ambiguous with discordant rates of diagnoses ranging from 25-43%," said Estrada. "The accuracy metrics shown in the development and validation study suggest DecisionDx DiffDx-Melanoma could help alleviate uncertainty in difficult-to-diagnose lesions, leading to decreased unnecessary procedures while appropriately identifying at-risk patients."

Study methods and findings:

DecisionDx DiffDx-Melanoma was designed to refine diagnoses of melanocytic neoplasms by providing clinicians with an objective ancillary tool with high accuracy.
A total of 503 formalin-fixed paraffin-embedded (FFPE) tissue samples sourced from primary cutaneous melanoma tumors and melanocytic nevi were used, of which 273 were benign and 230 were malignant lesions. Samples underwent quantitative polymerase chain reaction (qPCR) to evaluate expression of 76 genes with potential diagnostic utility.
Artificial intelligence approaches were used to select and prioritize gene sets, ultimately identifying 32 differentially expressed genes that reliably classified benign versus malignant melanocytic lesions.
The resulting 35-gene expression profile (GEP) test, DecisionDx DiffDx-Melanoma, (32 discriminant genes and 3 control genes) accurately diagnosed malignant and benign cases with 99.1% sensitivity, 94.3% specificity, 93.6% positive predictive value (PPV) and 99.2% negative predictive value (NPV).
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through September 30, 2020, DecisionDx-Melanoma has been ordered more than 64,560 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.SkinMelanoma.com.

About DecisionDx DiffDx-Melanoma

DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. Of the 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. DecisionDx DiffDx-Melanoma classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, DecisionDx DiffDx-Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists while helping dermatologists deliver more informed patient management plans.

More information about the test and disease can be found at www.CastleTestInfo.com.

On November 12, 2020 ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, reported financial results for the third quarter ended September 30, 2020 and provided recent business highlights (Press release, ADC Therapeutics, NOV 12, 2020, View Source [SID1234570825]).

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"The third quarter was one of tremendous execution as we prepare for the U.S. launch of our first drug, Lonca, for the treatment of relapsed or refractory diffuse large B-cell lymphoma," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "We have submitted our Biologics License Application to the U.S. Food and Drug Administration and are now working diligently to prepare for a planned commercial launch in mid-2021, including U.S. organizational build-out, the establishment of U.S. operations to ensure distribution, access and reimbursement of Lonca, and significant appropriate physician engagement. In addition to our commercial preparations, we are expanding our Lonca development activities, having initiated our Phase 3 LOTIS 5 clinical trial evaluating Lonca in combination with rituximab as a second-line therapy in DLBCL and are preparing to initiate our Phase 2 trial of Lonca in follicular lymphoma next year."

Dr. Martin continued, "Across our Cami programs, we have now enrolled more than half of the 100-patient pivotal Phase 2 trial in Hodgkin lymphoma and continue to see promising preliminary data from our Phase 1b trial in solid tumors that show robust immune activity following treatment, as well as recently published preclinical data highlighting the anti-tumor activity of CD25-targeted antibody drug conjugates. With these promising data, we expanded our Phase 1b trial to evaluate Cami in combination with pembrolizumab to better understand its potential as both a monotherapy and in combination and have dosed the first patient in the combination arm. To support these exciting developments and ensure continued growth across our pipeline, we completed an upsized public offering in September. With these additional funds, we look forward to continuing to deliver on our vision to bring transformative therapies to cancer patients as quickly and effectively as possible."

Recent Clinical and Business Highlights:

Submitted a BLA to the FDA for Lonca for treatment of relapsed or refractory DLBCL: On September 21, 2020, the Company announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Lonca for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The submission is based on data from LOTIS 2, a pivotal Phase 2 multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL following two or more lines of prior systemic therapy.
Opened Phase 3 LOTIS 5 clinical trial of Lonca in combination with rituximab for enrollment: This Phase 3 confirmatory trial will evaluate the efficacy of Lonca in combination with rituximab in patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). The trial will evaluate the safety and efficacy of Lonca in combination with rituximab versus standard immunochemotherapy, and the primary endpoint will be progression-free survival. LOTIS 5 is designed to fulfill the Company’s post-marketing requirement to the FDA for full approval, if accelerated approval is received for relapsed or refractory DLBCL, and is intended to support a supplemental Biologics License Application (sBLA) for Lonca as a second-line therapy for patients with DLBCL who have relapsed or refractory disease following at least one multi-agent systemic treatment regimen.
Actively enrolling patients in the pivotal Phase 2 portion of LOTIS 3 clinical trial of Lonca in combination with ibrutinib: Enrollment continues in the pivotal Phase 2 portion of LOTIS 3, a 161-patient Phase 1/2 clinical trial of Lonca in combination with ibrutinib, which is being evaluated in patients with relapsed or refractory DLBCL or mantle cell lymphoma (MCL). The first patient was dosed in the pivotal Phase 2 portion of this trial in July 2020.
Planning to initiate a pivotal Phase 2 clinical trial of Lonca in follicular lymphoma (FL) in H1 2021: The Company continues to consider rapid expansion opportunities for Lonca across other non-Hodgkin lymphoma indications. Following consultation with the FDA, the Company plans to initiate a pivotal Phase 2 trial to evaluate the safety and efficacy of Lonca in patients with relapsed or refractory FL.
Dosed first patient in Phase 1b clinical trial of Cami in combination with pembrolizumab for treatment of solid tumors: Earlier this month, the Company announced that the first patient was dosed with Cami in combination with pembrolizumab, a checkpoint inhibitor, in an ongoing Phase 1b trial in patients with selected advanced solid tumors. Based on preclinical data and initial pharmacodynamic data from the Phase 1b monotherapy trial, the Company has expanded the Phase 1b trial to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of Cami in combination with pembrolizumab in select solid tumors. Pharmacokinetic and biomarker data from the Phase 1b trial were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, and preclinical data were published in the Journal for ImmunoTherapy of Cancer.
Announced multiple abstracts accepted for presentation at ASH (Free ASH Whitepaper): The Company announced earlier in November that six clinical abstracts and two preclinical abstracts have been accepted for presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, including an oral presentation of Cami Phase 2 data in Hodgkin lymphoma (HL) and poster presentations of Lonca subgroup data from the pivotal Phase 2 LOTIS 2 trial in relapsed or refractory DLBCL and the Phase 1b pivotal trial of Lonca combined with ibrutinib in relapsed or refractory DLBCL and MCL.
Amended 2013 collaboration and license agreement with Genmab for Cami: In October 2020, the Company and Genmab agreed to amend their original 2013 agreement to allow the Company to continue the development and commercialization of Cami. Under the amendment, Genmab agreed, among other things, to convert its economic interest into a mid-to-high single-digit royalty on net sales.
Completed upsized public offering: In September 2020, the Company completed an upsized public offering of 6,000,000 common shares at a price of $34.00 per share. Gross proceeds from the public offering, before deducting underwriting discounts and commissions and offering expenses payable by the Company, were approximately $204 million.
Anticipated Upcoming Milestones:

FDA feedback on BLA submission for Lonca for the treatment of patients with relapsed or refractory DLBCL.
Initiation of a pivotal Phase 2 trial of Lonca in relapsed refractory FL in the first half of 2021.
Reporting of interim results from the pivotal Phase 2 trial of Cami in HL in the first half of 2021.
Potential FDA approval and launch of Lonca in mid-2021.
Third Quarter 2020 Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $494.4 million as of September 30, 2020, compared to $115.6 million as of December 31, 2019.

Research and Development (R&D) Expenses

R&D expenses were $32.2 million for the quarter ended September 30, 2020, compared to $30.5 million for the same quarter in 2019. The increase was primarily due to increased share-based compensation expense.

General and Administrative (G&A) Expenses

G&A expenses were $20.3 million for the quarter ended September 30, 2020, compared to $2.3 million for the same quarter in 2019. The increase was primarily due to an increased number of Commercial employees, increased costs due to new commercial activities and increased share-based compensation expense.

Net Loss and Adjusted Net Loss

Net loss was $20.3 million, or a net loss of $0.29 per basic and diluted share, for the quarter ended September 30, 2020, compared to $31.3 million, or a net loss of $0.62 per basic and diluted share, for the same quarter in 2019. The net loss for the quarter ended September 30, 2020 includes a $33.9 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. The decrease in fair value was driven by the decrease in the Company’s share price from June 30, 2020. In addition, net loss included share-based compensation expense of $11.0 million for the quarter ended September 30, 2020, compared to $0.2 million for the same quarter in 2019.

Adjusted net loss was $41.3 million, or an adjusted net loss of $0.58 per basic and diluted share, for the quarter ended September 30, 2020, compared to $31.1 million, or an adjusted net loss of $0.62 per basic and diluted share, for the same quarter in 2019. The increase in adjusted net loss was primarily driven by higher employee headcount across the organization and costs associated with the build out of the Company’s commercial organization in preparation for the anticipated launch of Lonca in 2021.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss third quarter 2020 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the call, please dial +41 225 675632 (international) or (833) 249-8403 (U.S.). A live webcast of the presentation will be available on the Investors section of the ADC Therapeutics website at www.ir.adctherapeutics.com. The archived webcast will be available after the completion of the event.