On August 5, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported its operational and financial results for the quarter ended June 30, 2021 (Press release, Autolus, AUG 5, 2021, View Source [SID1234585932]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are very encouraged by the obe-cel data in adult acute lymphoblastic leukemia (ALL) and in B-cell non-Hodgkins Lymphoma (B-NHL) presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress in June. In adult patients with ALL, event-free survival stabilized at 50% with 12 months follow up and was sustained at 24 months. These data indicate that obe-cel may be the first stand-alone therapy in adult ALL with curative potential in a last line setting. The FELIX trial is progressing well, and we expect pivotal data during 2022," said Dr. Christian Itin, chief executive officer of Autolus. "Additional data were presented at EHA (Free EHA Whitepaper) for obe-cel in indolent B-NHL indicating a high level of clinical activity combined with a well manageable safety profile. Further data in patients with aggressive B-NHL and chronic lymphocytic leukemia (CLL) are expected by the end of the year."

Key Pipeline Updates:

Obe-cel in relapsed / refractory (r/r) adult B-Acute Lymphocytic Leukemia (ALL).
Data presented at EHA (Free EHA Whitepaper) in June 2021 from the ALLCAR19 trial in r/r adult ALL patients demonstrated that obe-cel was generally well tolerated, with no patients experiencing Grade 3 or higher cytokine release syndrome (CRS). Three patients (15%), all of whom had high leukemia burden (>50% blasts), experienced Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) that resolved swiftly with steroids. Of the 20 patients treated with obe-cel, 17 (85%) achieved minimum residual disease (MRD)-negative complete remission (CR) at one month. Most notably, as of the data cutoff date of May 17, 2021, the durability of remissions is encouraging. Across all treated patients, event free survival (EFS) at twelve months and twenty-four months was 50.2% with median EFS not being reached.
Obe-cel in other relapsed/refractory B-NHL – ALLCAR19 extension (Cohort D)
Data presented at EHA (Free EHA Whitepaper) in June 2021 in r/r B-NHL (Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL)) patients demonstrated that, as of the data cut-off date of May 17, 2021, 9 r/r B-NHL patients (7 FL, 2 MCL) infused with obe-cel achieved a complete metabolic remission and, apart from one, all evaluable patients remained in CR. Obe-cel has a tolerable safety profile in adult patients with r/r FL and MCL, despite high disease burden. Grade 1 CRS was reported in 4 patients and Grade 2 CRS in 1 patient. No ICANS of any grade was observed in the trial.
Obe-cel in high grade B-NHL and CLL – ALLCAR19 extension (Cohorts B & C)
The ALLCAR extension trial also involves two cohorts of patients with high grade B-NHL (DLBCL) and CLL. These cohorts are progressing well and Autolus plans to present updated data at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting in December 2021.
Autolus received preferred regulatory access for obe-cel from UK Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA):
Autolus received an innovative licensing and access pathway (ILAP) designation from the MHRA for obe-cel being investigated in the ongoing FELIX trial in ALL.
Autolus received PRIority MEdicines (PRIME) designation from the EMA.
These designations are designed to accelerate the review of a promising therapy targeting an unmet medical need. Data from the FELIX trial is expected in 2022, which, if positive, could enable Autolus to file for accelerated approval.
AUTO4 in Peripheral T Cell Lymphoma (PTCL).
Autolus received ILAP designation from the MHRA for AUTO4 being investigated in PTCL.
AUTO4 Phase 1 clinical trial is progressing through dose escalation and Autolus expects to provide a next data update in the first half of 2022.
Operational Highlights:

Post the period end, in July 2021, Autolus announced an agreement with Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, granting Moderna an exclusive license to develop and commercialize mRNA-based therapeutics incorporating Autolus’ proprietary binders to up to four immuno-oncology targets. Under the terms of the agreement, Autolus would be eligible to receive an upfront payment for each target licensed by Moderna and development and commercial milestone payments for each product successfully commercialized. In addition, Autolus will be entitled to receive royalties on net sales of all products commercialized under the agreement. The use of the technology in Moderna’s mRNA platform underscores Autolus’ leadership in the development of innovative differentiated binder and cell programming technologies.

Post the period end, in July 2021, Autolus announced the appointment of Edgar Braendle M.D., Ph.D., as chief development officer. Dr Braendle is an experienced oncologist who joined Autolus from Sumitomo Dainippon Pharma Oncology, where he held the position of Chief Medical Officer and Global Head of Development and was responsible for leading the global oncology development programs of Sumitomo Dainippon. He is part of Autolus’ executive team and is leading the company’s development organization. In addition, Wolfram Brugger M.D., Ph.D. joined Autolus as VP, Head of Clinical Development in June 2021. Wolfram is a highly experienced hematologist, medical oncologist, and internal medicine specialist with 21 years of academia and hospital-based clinical physician experience in hematological malignancies in Germany, including 15 years of leadership as Chief Medical Director at the teaching hospital of Freiburg University. Wolfram joined Autolus from MorphoSys, where he was Head of Global Clinical Programs and oversaw the development of Monjuvi (tafasitamab).
Key Upcoming Clinical Milestones:

Obe-cel updates from the ALLCAR19 extension trial in patients with r/r B-NHL and longer term follow up of the fully enrolled r/r aALL cohort in H2 2021

Obe-cel currently enrolling the FELIX trial in r/r adult ALL patients with pivotal data expected in 2022

Updates on the obe-cel Phase 1 trial, CAROUSEL, in Primary CNS Lymphoma in Q1 2022

Updates on the AUTO1/22 CARPALL extension trial in pediatric ALL in Q4 2021

Updates on the AUTO4 Phase 1 trial in TRBC1+ Peripheral TCL in H1 2022

Phase 1 trials are expected to be initiated in H2 2021 with AUTO8 in Multiple Myeloma

Phase 1 trials are expected to be initiated in H1 2022 with AUTO6NG in solid tumors and AUTO5 in TRBC2+ Peripheral TCL

First exploratory allogeneic development candidate expected to enter the clinic in 2021
Financial Results for the Quarter Ended June 30, 2021

Cash at June 30, 2021, totaled $216.4 million, as compared to $239.0 million at March 31, 2020. During the three months ended June 30, 2021, the company issued an aggregate of 2,069,466 ADSs under its Sales Agreement with Jefferies for net proceeds, after underwriting discounts and offering expenses, of $14.3 million.

Net total operating expenses for the three months ended June 30, 2021 were $37.7 million, net of grant income and license revenue of $1.6 million, as compared to net operating expenses of $39.5 million, net of grant income of $0.3 million, for the same period in 2020.

Research and development expenses increased to $32.1 million for the three months ended June 30, 2021, from $31.3 million for the three months ended June 30, 2020. Cash costs, which exclude depreciation and amortization as well as share-based compensation, increased to $29.2 million from $26.5 million. The increase in research and development cash costs of $2.7 million consisted primarily of (i) an increase in compensation and employment related costs of $0.7 million due to severance payments related to the reduction in workforce that started in the first quarter, and offset by a reduction in employment costs due to a decrease in headcount, (ii) an increase of $1.0 million in facilities costs related to the continued scaling of manufacturing operations, (iii) an increase of $0.9 million related to purchased materials, (iv) an increase of $0.3 million related to cell logistics, and (v) an increase of $0.3 million related to IT infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations. This was offset by a decrease of $0.4 million in clinical costs and $0.1 million of legal expenses.

Non-cash costs decreased to $2.9 million for the three months ended June 30, 2021, from $4.8 million for the three months ended June 30, 2020. The decrease is primarily related to share-based compensation expense included in research and development expenses, which decreased by $2.8 million as a result of the lower fair value of stock options recognized during the period, combined with forfeitures of incentive share options and unvested RSUs related to employees affected by the reduction in workforce. This was offset by an increase in depreciation of $0.9 million.

General and administrative expenses decreased to $7.2 million for the three months ended June 30, 2021, from $8.5 million for the three months ended June 30, 2020. Cash costs, which exclude depreciation expense as well as share-based expense compensation decreased to $6.6 million from $6.7 million. The decrease in general and administrative cash costs of $0.1 million related to decreases of (i) $0.3 million related to the reduction in workforce that began to take place in the first quarter, which reduced the headcount, and (ii) $0.3 million of expenses related to preparations for becoming a commercial stage company. These decreases were offset by an increase of $0.5 million in legal fees and directors & officers liability insurance premiums.

Non-cash costs decreased to $0.6 million for the three months ended June 30, 2021, from $1.8 million for the three months ended June 30, 2020. The decrease is mainly attributed to share-based compensation expense as a result of the lower fair value of stock options recognized during the period, combined with forfeitures of incentive share options and unvested RSUs related to employees affected by the reduction in workforce.

Other income/(expense) decreased by $2.3 million for the three months ended June 30, 2021, from other income of $0.5 million for the three months ended June 30, 2020, to an other expense of $1.8 million. The decrease was primarily due to the weakening of the U.S. dollar exchange rate relative to the pound sterling during the three months ended June 30, 2021 as compared to the three months ended June 30, 2020.

Income tax benefit decreased to $6.4 million for the three months ended June 30, 2021 from $7.0 million for the three months ended June 30, 2020 due to a decrease in the research and development expenditures which were qualifying for the quarter. As research and development credits fell at a faster rate than our net loss before income tax, this led to a lower effective tax rate. Research and development credits are obtained at a maximum rate of 33.35% of our qualifying research and development expenses, and the increase in the net credit was primarily attributable to an increase in our eligible research and development expenses.

Net loss attributable to ordinary shareholders was $33.2 million for the three months ended June 30, 2021, compared to $32.1 million for the same period in 2020. The basic and diluted net loss per ordinary share for the three months ended June 30, 2021 totaled $(0.47) compared to a basic and diluted net loss per ordinary share of $(0.62) for the three months ended June 30, 2020.

Autolus estimates that its current cash on hand will provide the Company with a cash runway into H1 2023.

Conference Call

Management will host a conference call and webcast today at 8:30 am ET/1:30 pm BST to discuss the company’s financial results and provide a general business update. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus’ website.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 9757293. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 9757293.

On August 5, 2021 Ultivue, Inc. and Fluidigm Corporation (Nasdaq:FLDM) reported a co-marketing agreement in which the companies will offer customers a comprehensive portfolio of workflow solutions for biomarker discovery and drug development (Press release, Ultivue, AUG 5, 2021, View Source [SID1234585948]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Ultivue, a leader in advancing precision medicine solutions by accelerating tissue biomarker discovery and validation develops unique assays for use in multiplex immunofluorescence imaging and analysis. Its proprietary InSituPlex technology is designed for fast and comprehensive exploration of biologically-relevant markers combined with same slide-H&E analysis in precious tissue samples.

Fluidigm is a leader in high-parameter imaging for the clinical translational research and clinical testing markets. It’s Imaging Mass Cytometry (IMC) technology is designed for highly multiplexed targeted interrogation of tissue sections for 40 or more protein markers in one scan, with distinct non-overlapping signals from element-labeled antibodies detected simultaneously for each sub-micrometer pixel.

The collaboration provides reseachers with end-to-end service capability for clinical and translational work. For example, InSituPlex technology is well suited to identify regions of interest that may require downstream, deep profiling with IMC. Customer access to both technologies can improve the efficiency of drug discovery programs and, in translational research, enable patient stratification to triage cases that require further investigation.

"Imaging Mass Cytometry has become integral to the clinical translational research and clinical testing markets," said Chris Linthwaite, Fluidigm President and CEO. "Through Fluidigm Therapeutic Insights Services, we will offer our customers access to our technology as well as that of Ultivue, providing optimum imaging solutions for biomarker discovery and drug development."

"Ultivue is at the forefront of innovation to provide unique biological insights for our customers," said Mark Rees, Vice-President of Business Development at Ultivue. "Our InSituPlex technology offers valuable profiling of the tissue and expands the depth of information possible from a single section that is complementary to the high-parameter capabilities of Imaging Mass Cytometry. We believe this joint offering with Fluidigm will now provide researchers a seamless workflow enabling a far more efficient biomarker discovery and drug development process."

BeiGene has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Exelixis has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

On August 4, 2021 McKesson Corporation (NYSE:MCK) reported results for the first quarter ended June 30, 2021 (Press release, McKesson, AUG 4, 2021, View Source [SID1234585716]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Fiscal 2022 First-Quarter Result Summary

"McKesson delivered record first-quarter earnings, marking another quarter of solid performance across all four operating segments," said Brian Tyler, chief executive officer. "As we execute against our strategic priorities, we are evolving our portfolio to drive long-term growth and create shareholder value. We remain optimistic that the momentum we’ve generated will continue given the strength we see across our businesses. Based on our first-quarter operating performance and current trends, we are raising our previous guidance range for fiscal 2022 Adjusted Earnings per diluted share to $19.80 to $20.40."

First-quarter revenues were $62.7 billion, an increase of 13% from a year ago, driven by growth in the U.S. Pharmaceutical segment, largely due to higher volumes from retail national account customers and market growth, partially offset by branded to generic conversions.

During the first quarter of fiscal 2022, McKesson committed to donate certain personal protective equipment (PPE) to charitable organizations to assist in COVID-19 recovery efforts. First-quarter earnings per diluted share from continuing operations of $3.09 included $164 million of pre-tax inventory charges on certain PPE and related products. First-quarter Adjusted Earnings per diluted share excluded $155 million of these charges for inventory which the company no longer intends to sell and will instead direct to charitable organizations.

First-quarter Adjusted Earnings per diluted share was $5.56 compared to $2.77 a year ago, an increase of 101%, driven by the recovery of prescription volumes and primary care patient visits following the onset of the COVID-19 pandemic. Adjusted Earnings per diluted share growth was also driven by a lower tax rate and the contribution from COVID-19 vaccine distribution and kitting programs with the U.S. government.

For the first three months of the fiscal year, McKesson returned $1.1 billion of cash to shareholders, which included $1.0 billion of common stock repurchases and $69 million of dividend payments. During the first three months of the fiscal year, McKesson used cash from operations of $1.6 billion, and invested $159 million in capital expenditures, resulting in negative Free Cash Flow of $1.8 billion. McKesson also used $1.0 billion of cash for payments related to the exercises of a put right option available to non-controlling shareholders of McKesson Europe that expired in June 2021.

Business Highlights

McKesson is playing a central role in the COVID-19 response efforts in the U.S. and abroad through the distribution of COVID-19 vaccines, ancillary supply kits, and COVID-19 tests.
McKesson’s partnership with the U.S. government was expanded to support the U.S. government’s international COVID-19 vaccine donation mission. Including vaccine distribution in the U.S. and related to the U.S. government’s international donation mission, McKesson has successfully shipped over 250 million COVID-19 vaccines on behalf of the U.S. government through July 31, 2021.
On July 7, 2021, McKesson announced that it has entered into an agreement to sell its European businesses in France, Italy, Ireland, Portugal, Belgium, and Slovenia to the PHOENIX group for approximately $1.5 billion, subject to certain adjustments under the agreement. The transaction is subject to customary closing conditions, including regulatory review, and is expected to close in fiscal 2023. McKesson is committed to exploring strategic alternatives for all remaining European businesses.
U.S. Pharmaceutical Segment

First-quarter revenues were $50.0 billion, an increase of 12%, driven by higher volumes from retail national account customers and market growth, partially offset by branded to generic conversions.
First-quarter Segment Operating Profit was $682 million. Adjusted Segment Operating Profit was $682 million, an increase of 16%, driven by the contribution from COVID-19 vaccine distribution and growth in distribution of specialty products to providers and health systems.
Prescription Technology Solutions Segment

First-quarter revenues were $881 million, an increase of 34%, driven by higher volumes of technology and service offerings to support biopharma customers and the recovery of prescription volumes.
First-quarter Segment Operating Profit was $104 million. Adjusted Segment Operating Profit was $139 million, an increase of 62%, driven by organic growth from access and adherence solutions and the recovery of prescription volumes.
Medical-Surgical Solutions Segment

First-quarter revenues were $2.5 billion, an increase of 40%, driven by improvements in primary care patient visits and increased sales of COVID-19 tests.
First-quarter Segment Operating Profit was $75 million and included $164 million of pre-tax inventory charges on certain PPE and related products. During the first quarter of fiscal 2022, McKesson committed to donate certain PPE to charitable organizations to assist in COVID-19 recovery efforts. First-quarter Adjusted Segment Operating Profit excluded $155 million of these charges for inventory which the company no longer intends to sell and will instead direct to charitable organizations.
Adjusted Segment Operating Profit was $257 million, an increase of 107%, driven by improvements in primary care patient visits and the contribution from kitting and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program.
International Segment

First-quarter revenues were $9.2 billion. On an FX-Adjusted basis, revenues were $8.3 billion, a decline of 3%, driven by the contribution of McKesson’s German wholesale business to a joint venture with Walgreens Boots Alliance which was completed during the third quarter of fiscal 2021, partially offset by volume recovery in the pharmaceutical distribution and retail pharmacy businesses.
First-quarter Segment Operating Profit was $53 million. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $151 million, an increase of 107%, driven by volume recovery in the pharmaceutical distribution and retail pharmacy businesses and distribution of COVID-19 tests and vaccines.
Company Updates

On July 21, 2021, McKesson announced that it negotiated a comprehensive proposed settlement agreement which, if all conditions are satisfied, would result in the settlement of a substantial majority of opioid lawsuits filed by state and local governmental entities.
McKesson’s Board of Directors declared an increase in the regular quarterly dividend to $0.47 per share of common stock, demonstrating McKesson’s commitment to returning cash to shareholders and confidence in its outlook.
For the sixth consecutive year, McKesson was named a "Best Place to Work for Disability Inclusion." McKesson earned a top-ranking score of 100 on the 2021 Disability Equality Index, a joint initiative of the American Association of People with Disabilities and Disabilities:IN.
Fiscal 2022 Outlook

McKesson raised fiscal 2022 Adjusted Earnings per diluted share guidance to $19.80 to $20.40 from the previous range of $18.85 to $19.45 to reflect strong first-quarter operating performance and increased contribution from the U.S. government’s COVID-19 vaccine distribution and kitting programs. Fiscal 2022 Adjusted Earnings per diluted share guidance assumes $0.45 to $0.55 related to U.S. government COVID-19 vaccine distribution and does not assume any contribution from COVID-19 vaccines designated for pediatric patients or booster shots. Guidance also assumes $0.35 to $0.45 related to the kitting and distribution of ancillary supplies. Additional modeling considerations will be provided in the earnings call presentation.

Conference Call Details

The company has scheduled a conference call for today, Wednesday, August 4th at 4:30 PM ET to discuss the company’s financial results. A live audio webcast of the conference call will be available on McKesson’s Investor Relations website at View Source An archive of the conference call will also be available on the company’s Investor Relations website at View Source

Upcoming Investor Events

McKesson management will be participating in the following investor conferences:

Morgan Stanley 19th Annual Healthcare Conference, September 13, 2021
Audio webcasts will be available live and archived on the company’s Investor Relations website at View Source A complete listing of upcoming events for the investment community, including details and updates, will be available on the company’s Investor Relations website.

Non-GAAP Financial Measures

GAAP refers to the U.S. generally accepted accounting principles. This press release includes GAAP financial measures as well as Non-GAAP financial measures, including Adjusted Gross Profit, Adjusted Operating Expenses, Adjusted Other Income, Adjusted Income Tax Expense, Adjusted Earnings, Adjusted Earnings per Diluted Share, Adjusted Segment Operating Profit, Adjusted Segment Operating Profit Margin, Adjusted Corporate Expenses, Adjusted Operating Profit, FX-Adjusted results and Free Cash Flow which are financial measures not calculated in accordance with GAAP. Refer to the "Supplemental Non-GAAP Financial Information" section of the accompanying financial statement tables for the definitions and usefulness of the Company’s Non-GAAP financial measures and the attached schedules for reconciliations of the differences between the Non-GAAP financial measures and their most directly comparable GAAP financial measures.

The Company does not provide forward-looking guidance on a GAAP basis as McKesson is unable to provide a quantitative reconciliation of this forward-looking Non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, certain litigation loss and gain contingencies, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.