On May 12, 2020 Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, reported its results from operations for the quarter ended March 31, 2020 (Press release, Medicure, MAY 12, 2020, View Source [SID1234557621]).

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Quarter Ended March 31, 2020 Highlights:

Recorded total net revenue from the sale of products of $3.0 million during the quarter ended March 31, 2020 compared to $4.9 million for the quarter ended March 31, 2019;

Recorded total net revenue from the sale of AGGRASTAT of $2.7 million during the quarter ended March 31, 2020 compared to $4.8 million for the quarter ended March 31, 2019;

Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA1) for the quarter ended March 31, 2020 was negative $1.3 million compared to adjusted EBITDA of negative $1.7 million for the quarter ended March 31, 2019; and

Net loss for the quarter ended March 31, 2020 was $1.5 million compared to net loss of $2.8 million for the quarter ended March 31, 2019.
Financial Results

Net revenues for the three months ended March 31, 2020 were $3.0 million compared to $4.9 million for the three months ended March 31, 2019. Net revenues from AGGRASTAT for the three months ended March 31, 2020 were $2.7 million compared to $4.8 million for the three months ended March 31, 2019. ZYPITAMAGTM and SNP contributed $163,000 and $31,000, respectively during the three months ended March 31, 2020. Additionally, ReDSTM contributed net revenue of $89,000 for the three months ended March 31, 2020 compared to $103,000 for the three months ended March 31, 2019.

The Company continues to show strong patient market share with AGGRASTAT, however, the market share is offset by increased price competition caused by enhanced generic Integrilin competition, which resulted in lower discounted prices for AGGRASTAT into the first quarter of 2020. There was also decreases in the volume of the product sold compared to 2019. The Company is beginning to see an increase in demand for ZYPITAMAGTM and expects growth in ZYPITAMAGTM revenues going forward.

Adjusted EBITDA for the three months ended March 31, 2020 was negative $1.3 million compared to negative $1.7 million for the three months ended March 31, 2019. The change in adjusted EBITDA for the three months ended March 31, 2020 is the result of lower selling, general and administration and research and development expenses, partially offset by lower revenues during the three months ended March 31, 2020 when compared to the same period in 2019.

Net loss for the three months ended March 31, 2020 was $1.5 million or $0.14 per share compared to net loss of $2.8 million or $0.18 per share for the three months ended March 31, 2019. The change in the net loss for the three months ended March 31, 2020 is the result of lower selling, general and administration and research and development expenses and a gain on foreign exchange, partially offset by lower revenues experienced during the three months ended March 31, 2020 when compared to the three months ended March 31, 2019.

At March 31, 2020, the Company had unrestricted cash totaling $12.7 million consistent with the $13.0 million of unrestricted cash held as of December 31, 2019. Cash flows used in operating activities for the three months ended March 31, 2020 totaled $822,000 compared to $1.9 million for the three months ended March 31, 2019.

All amounts referenced herein are in Canadian dollars unless otherwise noted.

Notes

(1) The Company defines EBITDA as "earnings before interest, taxes, depreciation, amortization and other income or expense" and Adjusted EBITDA as "EBITDA adjusted for non‑cash and non-recurring items". The terms "EBITDA" and "Adjusted EBITDA", as it relates to the three months ended March 31, 2020 and 2019 results prepared using IFRS, do not have any standardized meaning according to IFRS. It is therefore unlikely to be comparable to similar measures presented by other companies.

Conference Call Info:

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.

On May 11, 2020 Bristol Myers Squibb (NYSE: BMY) reported the presentation of data across its portfolio, aimed at addressing solid tumor and hematologic malignancies in 28 types of cancer, at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Scientific Program, which will take place from May 29 to May 31, 2020 (Press release, Bristol-Myers Squibb, MAY 11, 2020, View Source [SID1234557449]).

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Presentations will feature clinical and non-clinical studies highlighting the potential role of immunotherapy, including combination approaches, to deliver durable treatment outcomes in multiple hard-to-treat solid tumors. In hematology, presentations will demonstrate the company’s innovative research in multiple myeloma, through both BCMA-targeted CAR T and proof-of-concept CELMoD data, suggesting targeted protein degradation as a potential new treatment approach. In addition, precision treatment approaches will explore how new biomarker insights may aid in the selection of optimal therapies for patients based on disease biology.

Accepted abstracts will be available on the ASCO (Free ASCO Whitepaper) conference website on Wednesday, May 13 at 5 p.m. EDT and the embargo will lift for all data included in these presentations at that time. Overall, data from more than 50 company-sponsored studies and collaborations will be featured at the meeting:

Solid Tumor

First presentation of results from CheckMate -9LA evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) with limited chemotherapy, and three-year follow-up data from CheckMate -227 evaluating Opdivo plus Yervoy combination in first-line metastatic non-small cell lung cancer
Treatment-free survival data from analyses of Opdivo plus Yervoy in advanced melanoma and new data in patients with immunotherapy-resistant renal cell carcinoma (RCC)
Analyses of multiple biomarkers associated with Opdivo plus Yervoy or Opdivo in patients with RCC
Cell Therapy

Pivotal trial results from KarMMa study of idecabtagene vicleucel (ide-cel; bb2121), a potential first-in-class BCMA CAR T in multiple myeloma being developed with bluebird bio
Updated data from EVOLVE Phase 1 study of orva-cel (orvacabtagene autoleucel), a fully human BCMA CAR T being developed by Juno Therapeutics, a Bristol-Myers Squibb Company, in heavily pre-treated multiple myeloma patients
Hematology

First clinical disclosure for CC-92480, a novel CELMoD agent evaluated in combination with dexamethasone in patients with relapsed and refractory multiple myeloma
Multiple analyses from the QUAZAR-001 pivotal Phase 3 study evaluating CC-486 maintenance therapy in acute myeloid leukemia
"This year’s ASCO (Free ASCO Whitepaper) meeting underscores the science-driven approach of our development program in solid tumor and hematologic malignancies, our dedication to precision medicine, as well as our commitment to helping to deliver durable improvement in patient outcomes through potentially transformative therapies," said Samit Hirawat, M.D., executive vice president, chief medical officer, global drug development, Bristol Myers Squibb. "With the impact of COVID-19, we are committed to supporting patients with cancer and overcoming challenges that patients, physicians and the research community may face during this time. We look forward to coming together virtually to share important data that continues to advance innovation for patients."

Summary of Presentations:

Selected Bristol Myers Squibb studies at the 2020 ASCO (Free ASCO Whitepaper) Virtual Annual Meeting include:

Gastrointestinal Malignancies

Nivolumab (NIVO) + low-dose ipilimumab (IPI) as first-line (1L) therapy in microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): Two-year clinical update
Author: Heinz-Josef Lenz
Abstract: #4040
Poster Session: Gastrointestinal Cancer—Colorectal and Anal (Poster: #32)
Phase 3 APACT trial of adjuvant nab-paclitaxel plus gemcitabine (nab-P + gem) vs. gem alone for patients with resected pancreatic cancer (PC): outcomes by geographic
Author: Reni
Abstract: #4515
Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary (Poster: #123)
Genitourinary Malignancies

Biomarker analyses from the Phase 3 CheckMate -214 trial of Opdivo plus Yervoy or sunitinib in aRCC
Author: Motzer
Abstract: #5009
Clinical Science Symposium: Updates on Immunotherapy Biomarkers Development in Kidney and Bladder Cancers
Evaluation of predictive biomarkers for Opdivo in patients with mccRCC from the CheckMate -025 (CM -025) trial
Author: Ficial
Abstract: #5023
Poster Session: Genitouinary Cancer—Kidney and Bladder (Poster: #92)
FRACTION-RCC: Innovative, high-throughput assessment of Opdivo plus Yervoy for treatment refractory aRCC
Author: Choueiri
Abstract: #5007
Oral Session: Genitourinary Cancer—Kidney and Bladder
Immunogenomic characterization of advanced clear cell RCC treated with PD-1 blockade
Author: Braun
Abstract: #5010
Clinical Science Symposium: Updates on Immunotherapy Biomarkers Development in Kidney and Bladder Cancers
Leukemia

CC-486 is safe and well-tolerated as maintenance therapy in elderly patients (≥75 years) with acute myeloid leukemia (AML) in first remission following induction chemotherapy: Results from the phase III QUAZAR AML-001 trial
Author: Ravandi
Abstract: #7530
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant (Poster: #303)
Enasidenib plus azacitidine significantly improves complete remission and OR vs azacitidine alone in patients with newly diagnosed AML with isocitrate dehydrogenase 2 (IDH2) mutations: Results of a randomized Phase 2 study
Author: DiNardo
Abstract: #7501
Oral Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Escalated dosing schedules of CC-486 for patients experiencing first acute myeloid leukemia (AML) relapse: Results from the phase III QUAZAR AML-001 maintenance trial
Author: Doehner
Abstract: #7513
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant (Poster: #286)
Health-related quality of life (HRQoL) in the Phase III QUAZAR-AML-001 trial of CC-486 maintenance therapy for patients with acute myeloid leukemia (AML) in first remission following induction chemotherapy (IC)
Author: Roboz
Abstract: #7533
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant (Poster: #306)
Longer-term RBC transfusion reduction in the Phase 3 MEDALIST study of luspatercept in patients with lower-risk MDS with ring sideroblasts (RS)
Author: Komrokji
Abstract: #7518
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant (Poster: #291)
Lymphoma

Burden of cytokine release syndrome (CRS) and neurologic events (NE) in patients (Pts) with relapsed/refractory non-Hodgkin lymphoma (NHL) receiving lisocabtagene maraleucel (Liso-cel; JCAR017) in TRANSCEND NHL 001
Author: Abramson
Abstract: #6637
Poster Session: Health Services Research, Clinical Informatics, and Quality of Care (Poster: #328)
Lisocabtagene maraleucel (liso-cel) for treatment of second-line (2L) transplant noneligible (TNE) relapsed/refractory (R/R) aggressive large B-cell non-Hodgkin lymphoma (NHL): updated results from the PILOT study
Author: Sehgal
Abstract: #8040
Poster Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia (Poster: #373)
Opdivo plus brentuximab vedotin for R/R classical Hodgkin lymphoma (cHL) in children, adolescents, and young adults (CAYA)
Author: Cole
Abstract: #8013
Poster Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia (Poster: #346)
Outpatient treatment with lisocabtagene maraleucel (liso-cel) across a variety of clinical sites from 3 ongoing clinical studies in relapsed/refractory (R/R) large B-cell lymphoma (LBCL)
Author: Bachier
Abstract: #8037
Poster Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia (Poster: #370)
Melanoma

Estimating treatment-free survival (TFS) over extended follow-up in patients (pts) with advanced melanoma (MEL) treated with immune-checkpoint inhibitors (ICIs): Five-year follow-up of CheckMate 067
Author: Regan
Abstract: #10043
Poster Session: Melanoma/Skin Cancers (Poster: #392)
Integrative tumor and immune cell multi-omic analyses predict melanoma response to immune checkpoint blockade 
Author: Anagnostou
Abstract: #10009
Clinical Science Symposium: Systems Biology Approaches to Immunotherapy Response and Toxicity
Multiple Myeloma

First-in-human phase I study of the novel CELMoD agent CC-92480 combined with dexamethasone (DEX) in patients (pts) with relapsed/refractory multiple myeloma (RRMM)
Author: Richardson
Abstract: #8500
Oral Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeted CAR T-cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM): Initial KarMMa results
Author: Munshi
Abstract: #8503
Oral Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Orvacabtagene autoleucel (orva-cel), a B-cell maturation antigen (BCMA)-directed CAR T cell therapy for patients (pts) with relapsed/refractory multiple myeloma (RRMM): update of the phase 1/2 EVOLVE study (NCT03430011)
Author: Mailankody
Abstract: #8504
Oral Session: Hematologic Malignancies—Plasma Cell Dyscrasia
KarMMa-RW: a study of real world treatment patterns in heavily pretreated patients with relapsed and refractory multiple myeloma (RRMM) and comparison of outcomes to KarMMa
Author: Jagannath
Abstract: #8525
Poster Session: Hematologic Malignancies—Plasma Cell Dyscrasia (Poster: #425)
Non-Small Cell Lung Cancer

Nivolumab + ipilimumab versus platinum-doublet chemotherapy as first-line treatment for advanced non-small cell lung cancer: Three-year update from CheckMate -227 Part 1
Author: Ramalingam
Abstract: #9500
Oral Session: Lung Cancer—Non-Small Cell Metastatic
Nivolumab (NIVO) + ipilimumab (IPI) + 2 cycles of platinum-doublet chemotherapy (chemo) vs 4 cycles chemo as first-line (1L) treatment (tx) for stage IV/recurrent non-small cell lung cancer (NSCLC): CheckMate -9LA
Author: Reck
Abstract: #9501
Oral Session: Lung Cancer—Non-Small Cell Metastatic
Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational chimeric antigen receptor (CAR) T-cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

On May 11, 2020 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported corporate updates and financial results for the first quarter ended March 31, 2020 (Press release, CymaBay Therapeutics, MAY 11, 2020, View Source [SID1234557487]).

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Sujal Shah, President and CEO of CymaBay, stated, "Last week a panel of some of the most experienced and distinguished liver pathologists and hepatologists in the world completed an independent review analyzing findings from our Phase 2b study of seladelpar in patients with NASH. I am pleased to report that the panel unanimously concluded there was no clinical, biochemical or histological evidence of seladelpar-induced liver injury in the study, and as a result they also unanimously supported the lifting of the clinical hold and re-initiation of clinical development.

While we have not yet discussed full results from our investigation nor any of the panel’s conclusions with the FDA, we are planning to re-engage with the agency as quickly as possible. At this point we cannot guarantee what the next steps or timelines will be, but we are confident that we have conducted a truly rigorous, independent review to help us definitively support the conclusion that seladelpar did not cause drug-induced liver injury in our NASH phase 2b study."

Dr. Paul Watkins, Howard Q Ferguson Distinguished Professor, Schools of Medicine, Pharmacy, and Public Health, Director, Institute for Drug Safety Sciences at the University of North Carolina, Chapel Hill, said, "I was pleased to chair this esteemed independent panel of liver experts. The panel conducted a comprehensive, systematic review and discussion of all of the clinicopathological data from the seladelpar NASH Phase 2b study. In my experience, no other drug in development for NASH has been through such rigorous scrutiny of safety data at this stage of development. As we have stated, the features noted by study pathologists at end of treatment were confirmed on this review. However, these did not differ qualitatively between baseline and end of treatment. We suspect these histologic features are underreported; however, in the experience of the pathology review subcommittee, these features may be observed in patients with NASH. The panel unanimously concluded that the data in aggregate, including the lack of significant differences in histologic features or their changes across the placebo and treatment groups, do not support injury related to seladelpar."

Dr. Stephen Harrison, Medical Director, Pinnacle Clinical Research, Visiting Professor of Hepatology at Radcliffe Department of Medicine, University of Oxford, and principal investigator of the seladelpar Phase 2b study in NASH, added, "I believe CymaBay and the FDA did the right thing in putting patient safety first when development of seladelpar was halted at the end of last year until an in-depth investigation was conducted into the findings identified by study pathologists in the NASH study. At this point, the findings and additional data collected have been thoroughly investigated by leading experts in the areas of drug-induced liver injury and hepatopathology. Given the benefit observed on both NASH resolution and fibrosis with seladelpar in the NASH Phase 2b study as well as data presented at multiple medical meetings from studies of seladelpar in PBC, I am pleased that the independent review panel is supportive of restarting clinical development pending approval from the FDA."

Recent Corporate Highlights

At the end of last week, a panel of eight of the world’s foremost expert liver pathologists and hepatologists, whose collective experience relevant to CymaBay’s investigation includes drug-induced liver injury, NASH and cholestatic liver diseases, completed a four-day independent review analyzing findings from CymaBay’s NASH Phase 2b study. The panel unanimously supported lifting the clinical hold for seladelpar and re-initiation of clinical development. In addition to the chair, Dr. Paul Watkins, the panel included:
° Pierre Bedossa, MD, PhD, Professor of Pathology at the University Paris-Diderot, France, and Medical Director and CEO of LIVERPAT
° Michael Charlton, MD, Chief of Hepatology, Director of the Center for Liver Diseases and Medical Director of the Transplant Institute at the University of Chicago
° Zachary Goodman, MD, PhD, Director of Hepatic Pathology Consultation and Research, Center for Liver Disease, Inova Healthcare Services
° Neil Kaplowitz, MD, Professor of Medicine and Thomas H. Brem Chair in Medicine, Budnick Chair of Liver Disease, Keck School of Medicine, University of Southern California
° David Kleiner, MD, PhD, Head of Histopathology and Autopsy Pathology at the NIH and the Reference Pathologist for the Drug-Induced Liver Injury Network
° Willis Maddrey, MD, Professor Emeritus of Internal Medicine at The University of Texas Southwestern Medical Center
° John Vierling, MD, Professor of Medicine and Surgery, Baylor College of Medicine

CymaBay intends to reach out to the FDA to discuss all of the data it has collected to date and the results of the panel review meetings. Once initial feedback is gathered, CymaBay intends to submit a complete response to the seladelpar clinical hold to the FDA. The CymaBay Board of Directors has worked closely with management throughout the investigation and panel review and is in support of next steps to re-engage with the FDA.

As a reminder, during the fourth quarter of 2019, management implemented a restructuring program following the placement of the seladelpar program on clinical hold pending further investigation of the histologic observations noted by study pathologists in CymaBay’s Phase 2b NASH study and pending completion of its review of strategic options.

Late in the first quarter of 2020, the need for sustained cost containment was further underscored by the unexpected and rapid onset of the coronavirus pandemic and the associated travel restrictions and shelter-in-place orders issued by governmental authorities in jurisdictions where CymaBay, its partners, investigators, and vendors, conduct operations. In response to these measures, CymaBay has taken steps, such as enabling remote operations for all employees, which have allowed operating activities to continue as seamlessly as possible.

CymaBay will continue to closely monitor pandemic developments and their associated risks to the business, and will take actions available to mitigate them where possible. Further, all of CymaBay’s actions will be guided by a commitment to taking all steps possible to ensure the health and safety of its employees.

Held $176.2 million in cash, cash equivalents and short-term investments at March 31, 2020.
Mr. Shah continued, "As the next steps in our seladelpar investigation process become clear we will continue to keep our shareholders updated as appropriate, while also continuing to evaluate potential strategic alternatives. Further, we remain focused on cost containment and will look at additional steps we can take into fiscal year 2020 in order to closely control the Company’s operating expenses and associated cash burn."

First Quarter Ended March 31, 2020 Financial Results

Research and development expenses for the three months ended March 31, 2020 were $9.5 million, compared to $18.6 million for the three months ended March 31, 2019. Research and development expense in the first quarter of 2020 was significantly lower than the corresponding period in 2019 primarily due to declining clinical trial activities related to the Phase 3 PBC, Phase 2b NASH, and Phase 2 PSC clinical trials, and other studies, as efforts continue to scale back and shut down these studies as a result of the clinical hold on the seladelpar development program.

General and administrative expenses for the three months ended March 31, 2020 were $4.3 million, compared to $5.7 million for the three months ended March 31, 2019. General and administrative expenses in the first quarter of 2020 was lower than the corresponding period in 2019 due to lower continuing labor costs and other administrative expenses following restructuring efforts undertaken in the fourth quarter of 2019.

Net loss for the three months ended March 31, 2020 was $13.1 million, or ($0.19) per diluted share, compared to a net loss of $23.1 million, or ($0.37) per diluted share in the three months ended March 31, 2019. Net loss was lower in the first quarter of 2020 compared to the corresponding period in 2019 primarily due to a decrease in operating expenses, including clinical trial and labor related expenses.
Conference Call Details

CymaBay will host a conference call today at 4:30 p.m. ET to discuss first quarter 2020 financial results and provide a corporate update. To access the live conference call, please dial 855-327-6837 from the U.S. and Canada, or 631-891-4304 internationally, Conference ID# 10009543. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On May 11, 2020 Unum Therapeutics Inc. (NASDAQ: UMRX), a biopharmaceutical company focused on developing curative cell therapies for solid tumors, reported financial results for the first quarter ended March 31, 2020, and provided corporate updates (Press release, Unum Therapeutics, MAY 11, 2020, View Source [SID1234557514]).

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Recent Program and Corporate Highlights

Announced plans to prioritize resources towards advancing its preclinical program, BOXR1030, for the treatment of solid tumor cancers: On March 2nd, Unum announced a corporate restructuring plan to prioritize resources towards advancing its preclinical program, BOXR1030, for the treatment of solid tumor cancers. Unum’s BOXR1030 expresses a glypican-3 (GPC3) targeted CAR and incorporates the novel transgene glutamic-oxaloacetic transaminase 2 (GOT2) to improve T cell function in the solid tumor microenvironment by enhancing T cell metabolism. Unum has initiated formal preclinical development activities, including preclinical safety testing and cGMP manufacturing readiness activities, to support filing an investigational new drug (IND) application for BOXR1030 in late 2020.

Entered into a common stock purchase agreement for up to $25 million with Lincoln Park Capital Fund, LLC ("LPC"): Under the terms of the purchase agreement announced on March 20th, Unum Therapeutics will have the sole discretion to direct LPC to purchase up to $25 million in shares of its common stock over the 36-month term of the agreement based on the market prices prevailing at the time of each sale to LPC. Unum Therapeutics controls the timing and amount of any future sales of its stock, subject to various limitations including those under the NASDAQ listing rules, and there is no upper limit as to the price per share that LPC may pay for future stock issuances under the purchase agreement. LPC has agreed not to cause or engage in any direct or indirect short selling or hedging of Unum Therapeutics’ common stock. Unum Therapeutics maintains the right to terminate the common stock purchase agreement at any time, at its discretion, without any additional cost or penalty.

Exploring strategic options to maximize shareholder value. Following a review of its business, the Company recently initiated and continues a process to explore strategic alternatives focused on maximizing shareholder value, with Ladenburg Thalmann & Co. Inc. acting as Unum Therapeutics’ strategic financial advisor during this process. Potential strategic alternatives that may be evaluated include, but are not limited to, an acquisition, merger, business combination, in-licensing, or other strategic transaction. There can be no assurance that this process will result in any such transaction. Unum Therapeutics has not set a timetable for completion of this review process and does not intend to

comment further unless or until the Board of Directors has approved a definitive course of action, the review process is concluded, or it is determined that other disclosure is appropriate.

First Quarter 2020 Financial Results

Collaboration Revenue: Collaboration revenue recognized during the first quarter ended March 31, 2020 of $7.0 million compared to $3.1 million in the same period of 2019. Collaboration revenue includes the recognition of a portion of the upfront payment received from Seattle Genetics, Inc. as reimbursements for research and development costs, and increased during the quarter ended March 31, 2020 as a result of the conclusion of the ATTCK-17-01 Phase 1 clinical trial and the termination of the collaboration agreement.

R&D Expenses: Research and development expenses of $9.5 million for the first quarter ended March 31, 2020 compared to $12.4 million for the same period of 2019. Research and development expenses relate to ongoing costs for Phase 1 trials and the BOXR1030 preclinical program, as well as personnel-related costs to support these programs.

G&A Expenses: General and administrative expenses for the first quarter ended March 31, 2020 were $3.7 million, compared to $2.5 million for the same period of 2019. The increase is primarily related to increased personnel-related costs, including severance costs, as well as expenses required to operate as a public company.

Net Loss: Net loss attributable to common stockholders was $6.1 million, or $0.20 per share, for the first quarter ended March 31, 2020 compared with a net loss attributable to common stockholders of $11.7 million, or $0.39 per share, for the same period of 2019.

Cash and Cash Equivalents: As of March 31, 2020, Unum had cash and cash equivalents of $29.6 million. Unum believes that its existing cash and cash equivalents will fund operating expenses and capital expenditure requirements into mid-2021.

About Unum’s BOXR1030 and BOXR Platform

Unum’s BOXR1030 was discovered from its Bolt-on Chimeric (BOXR) platform that is designed to discover novel "bolt-on" transgenes to be co-expressed with CARs, a T-cell receptor, or ACTR, to help T cells survive longer and perform better in the solid tumor microenvironment. BOXR candidates consist of two main components: 1) a targeting receptor that directs the T cell to attack tumor cells, which may be a traditional CAR receptor, a T-cell receptor, or Unum’s ACTR receptor, and 2) a novel "bolt-on" transgene that improves the intrinsic function of the T cell. Once discovered, BOXR transgenes are designed to be incorporated into

several different types of therapeutic T cells, including both ACTR T cells and CAR-T cells, to impart new functionality to T cells.

Unum’s first product candidate selected from the BOXR platform, BOXR1030, expresses GPC3+ targeted CAR and incorporates the bolt-on GOT2 transgene to improve T cell function in the solid tumor microenvironment (TME) by enhancing T cell metabolism. Preclinical data with BOXR1030 was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2019. In preclinical studies, BOXR1030 T cells were resistant to suppressive TME-like conditions, showing improved T cell proliferation under both hypoxic and low glucose conditions compared with control GPC3+ CAR-T cells. In vivo, BOXR1030 demonstrated superior activity compared to the parental CAR-T with treated animals achieving complete tumor regressions. Tumor infiltrating lymphocytes isolated from the tumors of treated animals revealed that BOXR1030 cells were more resistant to dysfunction and had fewer markers of exhaustion as compared to the control CAR-T cells.

On May 11, 2020 Bionical Emas and Jazz Pharmaceuticals (NASDAQ: JAZZ) reported that they have entered into an agreement to provide appropriate patients in the United States (U.S.) who have relapsed Small Cell Lung Cancer (SCLC) lurbinectedin via an Expanded Access Program (EAP) (Press release, Bionical Emas, MAY 11, 2020, View Source [SID1234557531]). Lurbinectedin is an investigational drug under review by the U.S. Food and Drug Administration (FDA).

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The EAP is open to patients who are unable to enter clinical trials and for whom there are no appropriate alternative treatments while lurbinectedin is under regulatory review by the FDA. The EAP was originally launched in January 2020 between Bionical Emas and PharmaMar S.A. (PharmaMar), and now has successfully transitioned from PharmaMar to Jazz.

SCLC is an aggressive form of cancer that usually is diagnosed with advanced, often metastatic, disease, and often posing a worse prognosis when compared to other lung cancers.1 In the United States, approximately 10-15% of lung cancers are small cell.1 Approximately 30,000 new cases of SCLC are recorded in the U.S. every year.2

Lurbinectedin is a selective inhibitor of oncogenic transcription on which many cancers such as SCLC are particularly dependent.

"We are pleased to be working with Jazz on this important project allowing access to lurbinectedin to appropriate patients via an Expanded Access Program in the U.S.," said Tom Watson, Executive Vice President, Bionical Emas.

"Lurbinectedin provides further hope for patients suffering from relapsed SCLC who currently have limited treatment options. This EAP provides an important opportunity for those patients who are unable to enter clinical trials and for whom there are no appropriate alternative treatments, and we are pleased to support this program," said John Efthimiou, Chief Medical Officer, Bionical Emas.

A new drug application (NDA) for Lurbinectedin is under review by the FDA and has not yet been approved.

Healthcare professionals wishing to request access to lurbinectedin under the EAP or who would like to find out more should do so by emailing [email protected]. Further details concerning the EAP can be found on Clinicaltrials.gov.