Quest Diagnostics Prices $550 Million of Senior Notes

On May 11, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported the pricing of a public offering of $550 million aggregate principal amount of its 2.800% senior notes due 2031 under Quest Diagnostics’ shelf registration statement (Press release, Quest Diagnostics, MAY 11, 2020, View Source [SID1234557517]).

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Quest Diagnostics expects to receive the net offering proceeds upon closing on May 13, 2020, subject to customary closing conditions. The company intends to use the net proceeds from the offering for general corporate purposes, which may include the repayment of indebtedness. The indebtedness the company may repay with the net proceeds of the offering includes the company’s $550 million aggregate principal amount of 4.70% senior notes due 2021 and outstanding borrowings under the company’s senior unsecured revolving credit facility and secured receivables credit facility.

This press release shall not constitute an offer to sell or a solicitation of an offer to purchase any of these securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. This offering may be made only by means of a prospectus supplement and accompanying base prospectus, copies of which or information concerning this offering may be obtained by calling Goldman Sachs & Co. LLC, collect at 1 (212) 902-1171, J.P. Morgan Securities LLC, collect at 1 (212) 834-4533 or Mizuho Securities USA LLC, toll-free at 1 (866) 271-7403.

Fortress Biotech Reports Record First Quarter 2020 Financial Results and Recent Corporate Highlights

On May 11, 2020 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company, reported financial results and recent corporate highlights for the first quarter ended March 31, 2020 (Press release, Fortress Biotech, MAY 11, 2020, View Source [SID1234557515]).

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "The first quarter of 2020 was another record revenue quarter for Fortress Biotech. Revenue from our dermatology products marketed by our partner company, Journey Medical Corporation, increased 95% compared to the first quarter of 2019, demonstrating the strength of our commercial operations. We intend to acquire one to two new prescription products this year."

Dr. Rosenwald continued, "We also made significant progress across our robust pipeline of development-stage product candidates in the first quarter. Notably, IV tramadol was assigned a PDUFA date of October 10, 2020. If IV tramadol is approved by the FDA and Avenue Therapeutics is acquired, we would expect to realize approximately $48 million, plus future contingent value rights. After a strong start to the year, we look forward to delivering key value-creating catalysts throughout the rest of 2020."

Recent Corporate Highlights1:

Marketed Dermatology Products

·Our dermatology products are marketed by our partner company, Journey Medical Corporation.
·Our five marketed specialty dermatology products generated first quarter 2020 net revenues of $11.9 million, compared to first quarter 2019 net revenues of $6.1 million, representing growth of 95% year-over-year.
·We intend to acquire one to two new prescription products in 2020.

IV Tramadol

·In February 2020, the U.S. Food and Drug Administration ("FDA") accepted the submission of Avenue Therapeutics’ New Drug Application ("NDA") for IV tramadol for review and assigned a Prescription Drug User Fee Act ("PDUFA") date of October 10, 2020. Pending a positive outcome resulting in FDA approval and other certain conditions being satisfied, a merger between Avenue and InvaGen will be completed shortly thereafter, which would result in a potential net distribution to Fortress of approximately $48 million and future contingent value rights.

1 Includes product candidates in development at Fortress, majority-owned and controlled partners and partners in which Fortress holds significant minority ownership positions. As used herein, the words "we", "us" and "our" may refer to Fortress individually or together with our affiliates and partners, as dictated by context.

·In April 2020, Avenue announced that two e-posters highlighting efficacy and safety results from its Phase 3 program are available for online viewing from the cancelled Annual Regional Anesthesiology and Acute Pain Medicine Meeting hosted by the American Society of Regional Anesthesia and Pain Medicine ("ASRA").
oThe e-poster (816) titled "Intravenous Tramadol is Effective in Management of Postoperative Pain Following Abdominoplasty: A 3-arm Randomized Controlled Trial" presents data from the Phase 3 abdominoplasty study and can be found here.
oThe e-poster (1001) titled "IV tramadol – A New Treatment Option for Management of Post-Operative Pain: A Safety Trial Including Various Types of Surgery" presents data from the Phase 3 safety study and can be found here.
·IV Tramadol is currently in development at our partner company, Avenue Therapeutics, Inc.

CUTX-101

·In January 2020, the FDA granted Rare Pediatric Disease Designation to CUTX-101 for the treatment of Menkes disease.
·We intend to begin the rolling submission of the NDA for CUTX-101 to the FDA in the fourth quarter of 2020.
·CUTX-101 is currently in development at our partner company, Cyprium Therapeutics, Inc.

CAEL-101

·In March 2020, Caelum Biosciences, Inc. ("Caelum") began dosing patients in its Phase 2 dose selection clinical trial of CAEL-101, a light chain fibril-reactive monoclonal antibody for the treatment of AL amyloidosis.
·Caelum expects to begin its pivotal Phase 3 program in the second half of 2020.

Cosibelimab (formerly CK-301, an anti-PD-L1 antibody)

·In January 2020, we announced confirmation of the registration path for cosibelimab in metastatic cutaneous squamous cell carcinoma ("CSCC"). FDA feedback supports the plan to submit a BLA based on data from the ongoing Phase 1 clinical trial. Over one-third of enrollment is complete in the cohort of patients with metastatic CSCC. There is potential for cosibelimab to be differentiated both clinically and as a lower-cost alternative to available anti-PD-1/L1 mAbs.
·In April 2020, we announced that the U.S. Patent and Trademark Office has issued a composition of matter patent for cosibelimab. U.S. Patent No. 10,590,199 specifically covers the antibody, cosibelimab, or a fragment thereof, providing protection through at least May 2038, exclusive of any additional patent-term extensions that might become available.
·We anticipate presenting additional cosibelimab data in the second half of 2020 and expect to complete enrollment of our registration-enabling Phase 1 clinical trial in CSCC in 2021.
·Cosibelimab is currently in development at our partner company, Checkpoint Therapeutics, Inc.

MB-107 (Lentiviral Gene Therapy for XSCID)

·In April 2020, we announced that the European Medicines Agency ("EMA") granted Advanced Therapy Medicinal Product ("ATMP") classification to MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency ("XSCID"), also known as bubble boy disease.
·In May 2020, Mustang Bio submitted an Investigational New Drug ("IND") application with the FDA to initiate a multi-center Phase 2 clinical trial of MB-107 in newly diagnosed infants with XSCID who are under the age of two. The trial is expected to enroll 10 patients who, together with 15 patients enrolled in the current multicenter trial led by St. Jude Children’s Research Hospital, will be compared with 25 matched historical control patients who have undergone hematopoietic stem cell transplant ("HSCT"). The primary efficacy endpoint will be event-free survival. The initiation of this trial is currently on hold pending CMC clearance by the FDA. Mustang is targeting topline data from the trial in the second half of 2022.

·Mustang further expects to file an IND in the third quarter of 2020 for a registrational multi-center Phase 2 clinical trial of its lentiviral gene therapy in previously transplanted XSCID patients. This product will be designated MB-207. Mustang anticipates enrolling 20 patients and comparing them to matched historical control patients who have undergone a second HSCT. Mustang is targeting topline data for this trial in the second half of 2022.
·MB-107 is currently in development at our partner company, Mustang Bio, Inc.

MB-105 (PSCA-targeted CAR T cell therapy)

·In the ongoing Phase 1 trial at City of Hope with MB-105, a PSCA-directed CAR T administered systemically to patients with PSCA-positive castration resistant prostate cancer, the first patient to receive the therapy following a standard CAR T conditioning regimen experienced a significant reduction in his prostate-specific antigen (PSA) at day 28. This PSA response was associated with radiographic improvement of the patient’s metastatic disease.
·MB-105 is currently in development at our partner company, Mustang Bio, Inc.

MB-106 (CD20-targeted CAR T cell therapy)

·In February 2020, we announced that the first subject treated with the optimized MB-106 (CD20-targeted, autologous CAR T cell therapy) manufacturing process, developed in collaboration between Mustang Bio and the Fred Hutchinson Cancer Research Center, achieved a complete response at the lowest starting dose in an ongoing Phase 1/2 clinical trial. The trial is evaluating the safety and efficacy of MB-106 in subjects with relapsed or refractory B-cell non-Hodgkin lymphomas.
·MB-106 is currently in development at our partner company, Mustang Bio, Inc.

ONCOlogues (proprietary platform technology using PNA oligonucleotides)

·In May 2020, we entered into an exclusive worldwide licensing agreement with Columbia University to develop novel oligonucleotides for the treatment of genetically driven cancers. The proprietary platform produces oligomers, known as "ONCOlogues," which are capable of binding gene sequences 1,000 times more effectively than complementary native DNA.
oONCOlogues invade a DNA double helix and displace native mutated strands. This prevents the mRNA that antisense binds to from ever being created. It is higher upstream than an antisense approach as well as potentially more potent and broader in its utility.
·In addition, we are exploring the potential of the platform to treat novel coronaviruses, such as COVID-19.
·The "Suppression of KRAS-G12D and BRAF-V600E Oncogene Transcription with PNA Conjugates" data presentation from the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in 2019 can be found here.
·The ONCOlogues platform is currently in development at our partner company, Oncogenuity, Inc.

General Corporate

·In February 2020, we closed on a gross total of approximately $14.4 million in an underwritten public offering of our 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock.
·In March 2020, our Board of Directors authorized the repurchase of up to $5 million of Fortress’ 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (Nasdaq: FBIOP).

Financial Results:

To assist our stockholders in understanding our company, we have prepared non-GAAP financial results for the three months ended March 31, 2020 and 2019. These results exclude the operations of our three public partner companies: Avenue Therapeutics, Inc., Checkpoint Therapeutics, Inc. and Mustang Bio, Inc., as well as any one-time, non-recurring, non-cash transactions, such as the gain of $18.4 million we recorded in the first quarter of 2019 resulting from the de-consolidation of Caelum. The goal in providing these non-GAAP financial metrics is to highlight the financial results of Fortress’ core operations, which are comprised of our commercial-stage business, our privately held development stage entities, as well as our business development and finance functions.

·As of March 31, 2020, Fortress’ consolidated cash, cash equivalents and restricted cash totaled $152.5 million, compared to $153.4 million as of December 31, 2019, a decrease of $0.9 million during the quarter.
·Fortress’ net revenue totaled $12.9 million for the first quarter of 2020, which included $11.9 million in net revenue generated from our marketed dermatology products. This compares to net revenue totaling $6.5 million for the first quarter of 2019, which included $6.1 million in net revenue generated from our marketed dermatology products.
·On a GAAP basis, consolidated research and development expenses were $14.9 million for the first quarter of 2020, compared to $23.3 million for the first quarter of 2019. On a non-GAAP basis, research and development expenses were $2.3 million for the first quarter of 2020, compared to $1.6 million for first quarter of 2019.
·On a GAAP basis, consolidated research and development expenses from license acquisitions totaled $0.3 million for the first quarter of 2020, compared to $0.5 million for the first quarter of 2019.
·On a GAAP basis, consolidated general and administrative expenses were $15.5 million for the first quarter of 2020, compared to $13.5 million for the first quarter of 2019. On a non-GAAP basis, general and administrative expenses were $11.6 million, of which $5.6 million is attributed to Journey, for the first quarter of 2020, compared to $8.5 million, of which $3.9 million is attributed to Journey, for the first quarter of 2019.
·On a GAAP basis, consolidated net loss attributable to common stockholders was $12.4 million, or $0.19 per share, for the first quarter of 2020, compared to net income attributable to common stockholders of $1.4 million, or $0.03 per share for the first quarter of 2019, which includes the $18.4 million gain due to the de-consolidation of Caelum.
·Fortress’ non-GAAP loss attributable to common stockholders was $4.2 million, or $0.07 per share, for the first quarter of 2020, compared to Fortress’ non-GAAP loss attributable to common stockholders of $4.7 million, or $0.07 per share, for the first quarter of 2019.

Unum Therapeutics Reports First Quarter Financial Results and Provides Corporate Updates

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.

Molecular Templates, Inc. Reports First Quarter 2020 Financial Results

On May 11, 2020 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the first quarter of 2020 (Press release, Molecular Templates, MAY 11, 2020, View Source [SID1234557513]). As of March 31, 2020, MTEM’s cash and investments totaled $108 million, which is expected to fund operations into 2022.

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"We continue to make meaningful progress at MTEM despite the headwinds that COVID-19 has created for clinical trial site initiation and patient enrollment," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive Officer and Scientific Officer. "We expect to report interim clinical data this year from our three MT-3724 Phase II studies and our MT-5111 Phase I study. We also expect to present preclinical data on programs against new targets and file the IND for MT-6402, our PD-L1 targeted ETB with antigen seeding, by year-end."

Company Highlights, Pipeline Status, and Upcoming Milestones

Corporate

On February 19, 2020, MTEM announced the initiation of dosing in a Phase I study investigating TAK-169 in patients with relapsed/refractory multiple myeloma. Co-developed with Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited ("Takeda"), TAK-169 is a potential first-in-class CD38-targeting ETB. As a result of achieving this milestone, MTEM received a $10 million payment from Takeda.
Impact of COVID-19

The COVID-19 pandemic has resulted in a significant slowdown in the pace of site initiations and patient enrollment across our MT-3724 Phase II programs. As a CD20-targeting agent for the treatment of hematological malignancy, MT-3724 may impair the ability to generate humoral immunity to coronavirus infection. Physicians may be less inclined to enroll patients given this concern.
MT-5111 screening and enrollment has been less impacted than MT-3724 but is still enrolling at a slower pace than was projected pre-COVID-19.
To date, MTEM has been able to continue to work at its cGMP manufacturing facility and laboratories without interruption from COVID-19. As a result, manufacturing of product supply for clinical trials and research activities to support advancement of our preclinical pipeline (including partnered programs) have not been impacted to date by COVID-19.
During the COVID-19 pandemic, MTEM is carefully and continually evaluating the potential individual patient risk associated with continuing to enroll in MTEM’s existing studies and the degree of disruption to these studies and MTEM’s business generally.
MT-3724 (CD20 ETB)

MTEM is currently conducting three ongoing Phase II studies in relapsed/refractory diffuse large B-cell lymphoma (DLBCL): a monotherapy study that has the potential to be pivotal, a combination study with chemotherapy, and a combination study with lenalidomide.
MTEM expects to report updates on all three MT-3724 studies in 2H20.
TAK-169 (CD38 ETB)

Takeda and MTEM are conducting an ongoing Phase I study for TAK-169 in relapsed/refractory multiple myeloma.
MT-5111 (HER2 ETB)

MTEM is conducting an ongoing Phase I study of MT-5111 in HER2-positive cancers.
MTEM expects to provide a data update from the MT-5111 Phase I study in 2Q20 and release additional data from the dose escalation portion of the study in 4Q20.
Research

MTEM expects to file an IND application for MT-6402, its ETB targeting PD-L1 (with antigen seeding), in 2H20.
Several other ETB candidates are in preclinical development against targets including CTLA-4, SLAMF-7, and CD45.
MTEM expects to present preclinical data on several new targets ETB programs at upcoming medical conferences including the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, taking place June 22-24, 2020.
Financial Results

The net loss attributable to common shareholders for the first quarter of 2020 was $22.0 million, or $0.48 per basic and diluted share. This compares with a net loss attributable to common shareholders of $6.2 million, or $0.17 per basic and diluted share, for the same period in 2019.

Revenues for the first quarter of 2020 were $4.1 million, compared to $7.0 million for the same period in 2019. Revenues for the first quarter of 2020 were comprised of revenues from collaborative research and development agreements with Takeda and Vertex, as well as grant revenue from CPRIT. Total research and development expenses for the first quarter of 2020 were $20.6 million, compared with $8.4 million for the same period in 2019. Total general and administrative expenses for the first quarter of 2020 were $5.6 million, compared with $4.9 million for the same period in 2019.

Molecular Templates, Inc. Reports First Quarter 2020 Financial Results

On May 11, 2020 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the first quarter of 2020 (Press release, Molecular Templates, MAY 11, 2020, View Source [SID1234557512]). As of March 31, 2020, MTEM’s cash and investments totaled $108 million, which is expected to fund operations into 2022 .

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"We continue to make meaningful progress at MTEM despite the headwinds that COVID-19 has created for clinical trial site initiation and patient enrollment," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive Officer and Scientific Officer. "We expect to report interim clinical data this year from our three MT-3724 Phase II studies and our MT-5111 Phase I study. We also expect to present preclinical data on programs against new targets and file the IND for MT-6402, our PD-L1 targeted ETB with antigen seeding, by year-end."

Company Highlights, Pipeline Status, and Upcoming Milestones

Corporate

On February 19, 2020, MTEM announced the initiation of dosing in a Phase I study investigating TAK-169 in patients with relapsed/refractory multiple myeloma. Co-developed with Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited ("Takeda"), TAK-169 is a potential first-in-class CD38-targeting ETB. As a result of achieving this milestone, MTEM received a $10 million payment from Takeda.
Impact of COVID-19

The COVID-19 pandemic has resulted in a significant slowdown in the pace of site initiations and patient enrollment across our MT-3724 Phase II programs. As a CD20-targeting agent for the treatment of hematological malignancy, MT-3724 may impair the ability to generate humoral immunity to coronavirus infection. Physicians may be less inclined to enroll patients given this concern.
MT-5111 screening and enrollment has been less impacted than MT-3724 but is still enrolling at a slower pace than was projected pre-COVID-19.
To date, MTEM has been able to continue to work at its cGMP manufacturing facility and laboratories without interruption from COVID-19. As a result, manufacturing of product supply for clinical trials and research activities to support advancement of our preclinical pipeline (including partnered programs) have not been impacted to date by COVID-19.
During the COVID-19 pandemic, MTEM is carefully and continually evaluating the potential individual patient risk associated with continuing to enroll in MTEM’s existing studies and the degree of disruption to these studies and MTEM’s business generally.
MT-3724 (CD20 ETB)

MTEM is currently conducting three ongoing Phase II studies in relapsed/refractory diffuse large B-cell lymphoma (DLBCL): a monotherapy study that has the potential to be pivotal, a combination study with chemotherapy, and a combination study with lenalidomide.
MTEM expects to report updates on all three MT-3724 studies in 2H20.
TAK-169 (CD38 ETB)

Takeda and MTEM are conducting an ongoing Phase I study for TAK-169 in relapsed/refractory multiple myeloma.
MT-5111 (HER2 ETB)

MTEM is conducting an ongoing Phase I study of MT-5111 in HER2-positive cancers.
MTEM expects to provide a data update from the MT-5111 Phase I study in 2Q20 and release additional data from the dose escalation portion of the study in 4Q20.
Research

MTEM expects to file an IND application for MT-6402, its ETB targeting PD-L1 (with antigen seeding), in 2H20.
Several other ETB candidates are in preclinical development against targets including CTLA-4, SLAMF-7, and CD45.
MTEM expects to present preclinical data on several new targets ETB programs at upcoming medical conferences including the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, taking place June 22-24, 2020.
Financial Results

The net loss attributable to common shareholders for the first quarter of 2020 was $22.0 million, or $0.48 per basic and diluted share. This compares with a net loss attributable to common shareholders of $6.2 million, or $0.17 per basic and diluted share, for the same period in 2019.

Revenues for the first quarter of 2020 were $4.1 million, compared to $7.0 million for the same period in 2019. Revenues for the first quarter of 2020 were comprised of revenues from collaborative research and development agreements with Takeda and Vertex, as well as grant revenue from CPRIT. Total research and development expenses for the first quarter of 2020 were $20.6 million, compared with $8.4 million for the same period in 2019. Total general and administrative expenses for the first quarter of 2020 were $5.6 million, compared with $4.9 million for the same period in 2019.