On May 11, 2020 Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines, reported first quarter 2020 financial results and provided an overview of operational progress (Press release, Rubius Therapeutics, MAY 11, 2020, View Source [SID1234557554]).

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"During the first quarter, we made significant progress in advancing our business by reprioritizing our therapeutic areas of focus and progressing our oncology pipeline of Red Cell Therapeutics, including the dosing of our first patient in the RTX-240 clinical trial. RTX-240 is an allogeneic cellular therapy product candidate that is designed to mimic and amplify the functions of the innate and adaptive immune systems by activating and expanding NK cells and T cells to generate a potent anti-tumor response, potentially providing patients with a dual-mechanistic approach to fight their cancer," said Pablo J. Cagnoni, chief executive officer of Rubius Therapeutics. "With the advances in our oncology pipeline, a fully owned and operational manufacturing facility and cash runway that takes us into 2022, we believe we are well positioned to execute our objectives and bring potentially life-saving therapies to patients."

First Quarter and Recent Highlights

·Completed strategic reprioritization of the pipeline to focus on the development of oncology and autoimmune Red Cell Therapeutic programs.
oDevelopment in these therapeutic areas is enabled by the investment in internal manufacturing at the Rubius Smithfield, RI facility.
·Dosed the first patient in the Phase 1/2 clinical trial of RTX-240 for the treatment of patients with relapsed/refractory or locally advanced solid tumors.
oThe cGMP cells used to dose the first patient were produced at the fully owned Rubius manufacturing facility. All subsequent clinical supply for the Company’s oncology programs is expected to be produced from this facility.

·On track to file an Investigational New Drug application for lead artificial antigen-presenting cell program, RTX-321, for the treatment of HPV 16-positive cancers by year-end 2020.
·Unveiled abstracts for the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 23rd Annual Meeting, highlighting preclinical data from its oncology pipeline of Red Cell Therapeutics, including data supporting RTX-321.
oThe posters will be made available at the beginning of the virtual meeting tomorrow, Tuesday, May 12, 2020, at 6:00 a.m. ET.
·Implemented multiple measures in response to the COVID-19 pandemic to safeguard the health and well-being of employees, their families, business partners and healthcare providers, while continuing to operate its Smithfield, RI manufacturing facility and conduct research and development activities. The extent to which the COVID-19 pandemic may impact Rubius will depend on future developments.

First Quarter 2020 Financial Results

Net loss for the first quarter of 2020 was $48.5 million or $0.60 per common share, compared to $32.6 million or $0.42 per common share in the first quarter of 2019.

In the first quarter of 2020, Rubius invested $36.2 million in research and development (R&D) related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, compared to $20.9 million in the first quarter of 2019. The year-over-year increase was driven by $9.9 million of incremental costs incurred in advancing our cancer programs, including preparation for the Phase 1/2 clinical trial for RTX-240 and preclinical and IND-enabling activities for RTX-321. There was also a $1.6 million increase in costs incurred for our rare disease pipeline prior to the deprioritization of these programs in March 2020. In addition, costs not allocated to programs increased by $3.8 million, resulting from increases in personnel-related costs, stock-based compensation, contract research and development and facility related and other costs. These higher costs were driven by R&D headcount growth and expanded platform development and drug discovery activities.

G&A expenses were $12.7 million during the first quarter of 2020, compared to $13.5 million for the first quarter of 2019. The lower costs were primarily driven by a reduction in stock-based compensation expense.

Cash Position

As of March 31, 2020, cash, cash equivalents and investments were $241.4 million, compared to $283.3 million as of December 31, 2019, providing Rubius with a cash runway into 2022.

During the quarter, the Company used $40.0 million of cash to fund operations and $2.9 million to fund capital expenditures, consisting mostly of payments for assets purchased in 2019.

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.

On May 11, 2020 SQZ Biotechnologies (SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, reported that management will present a corporate overview at the UBS Virtual Global Healthcare Conference on May 18, 2020 at 10:50am EST (Press release, SQZ Biotech, MAY 11, 2020, View Source [SID1234557529]).

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The presentation will be available through the UBS Virtual Global Healthcare Conference webcast system linked here. Armon Sharei, PhD, chief executive officer, and Teri Loxam, chief financial officer, will also be hosting one-on-one meetings with investors through the virtual system.

On May 11, 2020 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage immunology and oncology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the first quarter ended 31 March 2020 and provided an update on its clinical activities (Press release, ASLAN Pharmaceuticals, MAY 11, 2020, View Source [SID1234557555]).

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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "The COVID-19 pandemic has brought about unprecedented changes and affected many worldwide. We have been putting strategies in place to mitigate risks to our development programs, including opening sites in different geographies where restrictions are easing. We are also taking steps to ensure that we emerge from this situation stronger and ready to initiate our planned phase 2b study of ASLAN004 for atopic dermatitis in 1H 2021, building our US presence as we grow a team there and prepare to file an Investigational New Drug application with the US FDA."

First quarter 2020 and recent business highlights

Clinical development

ASLAN004

As announced on 13 April, recruitment for the second dose cohort of the multiple ascending dose (MAD) study in atopic dermatitis (AD) has been paused in light of government restrictions in Singapore to contain the spread of COVID-19. ASLAN is closely monitoring government guidance around the restrictions, which were extended until 1 June 2020 on 21 April.

ASLAN still expects to announce unblinded, interim data from the study later this year but will review the timelines when the tightened restrictions are lifted in Singapore and recruitment into the study recommences.

To accelerate recruitment, ASLAN has identified several clinical sites in Australia that could join the ongoing MAD study.

Varlitinib

Two abstracts on varlitinib have been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) virtual congress on 29 May. An abstract on the results from the TreeTopp study was accepted for poster presentation and the second abstract, on the comparison of therapeutic responses by using CT imaging, will be available in the virtual library.

Anticipated upcoming milestones for ASLAN004

Interim, unblinded data from the 3 dose cohorts (up to 24 patients) expected in 2H 2020, and initiation of the expansion cohort (an additional 18 patients).

Opening of clinical trial sites in Australia and filing of IND application with the US FDA in the middle of 2020.

Completion of MAD clinical trial in moderate-to-severe AD patients in 1H 2021.

Initiation of Phase 2b study of ASLAN004 for AD in 1H 2021.

First quarter 2019 financial highlights

Cash used in operations for the first quarter of 2020 was US$5.2 million compared to US$7.2 million in the same

period in 2019.

Research and development expenses were US$2.4 million in the first quarter of 2020 compared to US$4.4 million in the first quarter of 2019. The decrease was driven by the completion of clinical studies related to varlitinib and lower manufacturing expenses.

General and administrative expenses were US$1.0 million in the first quarter of 2020 compared to US$2.3 million in the first quarter of 2019. The decrease was primarily due to earlier restructuring efforts which resulted in a decrease in headcount and staffing costs.

Net loss for the first quarter of 2020 was US$3.0 million compared to a net loss of US$4.3 million for the first quarter of 2019.

Cash, cash equivalents and short-term investments totaled US$16.9 million as of 31 March 2020 compared to US$22.2 million as of 31 December 2019. Weighted average shares outstanding for the first quarter of 2020 was 190.0 million compared to 160.2 million for the first quarter of 2019. One American Depositary Share is the equivalent of five ordinary shares.

On May 11, 2020 Cardinal Health (NYSE: CAH) reported financial results for the third quarter of fiscal 2020 ended March 31, 2020 (Press release, Cardinal Health, MAY 11, 2020, View Source [SID1234557448]).Third quarter revenue was $39.2 billion, an increase of 11% from the third quarter of last year.

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Third quarter GAAP operating earnings increased 30% to $562 million. Non-GAAP operating earnings increased 8% to $719 million. GAAP diluted earnings per share (EPS) increased 20% to $1.19, while non-GAAP diluted EPS increased 2% to $1.62.

"I want to express my gratitude to our employees and our partners across the healthcare industry for their incredible efforts to help us perform our critical role in the supply chain during this unprecedented time," said Mike Kaufmann, CEO of Cardinal Health. "We remain committed to delivering products and solutions to front-line health care providers so they can safely serve and treat patients around the world. As we look toward and beyond the fourth quarter, we will continue to take strategic actions to fulfill this mission."

During the third quarters of fiscal 2020 and 2019, GAAP effective tax rates were 26.8% and 20.0%, respectively. Non-GAAP effective tax rates were 25.7% and 21.6%

Third quarter revenue for the Pharmaceutical segment increased 12 percent to $35.1 billion, due to sales growth from Pharmaceutical Distribution customers and, to a lesser extent, Specialty Solutions customers. This growth included an acceleration in overall pharmaceutical sales in March, which the company believes was due to the COVID-19 pandemic.

Pharmaceutical segment profit was flat at $534 million in the third quarter. This reflects strong performance in the company’s generics program and the adverse impact of Pharmaceutical Distribution customer contract renewals.

Third quarter revenue for the Medical segment increased 5 percent to $4.1 billion, due to growth in products and distribution and Cardinal Health at Home.

Medical segment profit increased 15 percent to $178 million in the third quarter due to an increase in products and distribution, including benefits from global manufacturing and cost savings initiatives.

Fiscal year 2020 Outlook
While both segments experienced a modest net positive impact in the third quarter from increased volume related to the COVID-19 pandemic, the company expects a significant net negative impact to fourth quarter financial results in both segments. This is driven most meaningfully by a decrease in volume related to the cancellation or deferral of elective medical procedures.

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

The company reaffirms its fiscal year 2020 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. of $5.20 to $5.40.

Recent highlights

Jason Hollar joined the company on April 27 and will become Chief Financial Officer on May 26. Jason previously served as CFO of Tenneco Inc. and Sears Holdings Corporation.

Cardinal Health board of directors approved a quarterly dividend of $0.4859 per share. The dividend will be payable on July 15, 2020 to shareholders of record at the close of business on July 1, 2020.

The company was recognized as a "2020 NAFE Top Companies for Executive Women" by the National Association for Female Executives for the ninth consecutive year.

Webcast
Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss third quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until May 10, 2021.