On May 5, 2022 McKesson Corporation (NYSE:MCK) reported results for the fourth-quarter and fiscal year ended March 31, 2022 (Press release, McKesson, MAY 5, 2022, View Source [SID1234613841]).

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 Fourth-Quarter and Full-Year Result Summary

"McKesson delivered strong financial performance in fiscal 2022," said Brian Tyler, chief executive officer. "Our transformation to a diversified healthcare services company is underway and our strategy is working."

"We are encouraged by the growth in our strategic pillars of oncology and biopharma services, and the strength in our core North American distribution businesses," Mr. Tyler continued. "Our results reflect the unwavering commitment of our employees and their resilience to deliver for our customers, patients, our communities, and our shareholders. We are excited about the opportunities ahead of us to advance healthcare outcomes for all in fiscal 2023 and beyond."

Fourth-quarter revenues were $66.1 billion, an increase of 12% from a year ago, and full-year revenues were $264.0 billion, an increase of 11%, primarily driven by growth in the U.S. Pharmaceutical segment, due to increased volumes of specialty products, including higher volumes from retail national account customers, and market growth, partially offset by branded to generic conversions.

Fourth-quarter earnings per diluted share from continuing operations was $2.48 compared to $4.15 a year ago, a decrease of $1.67. Full-year earnings per diluted share from continuing operations was $7.26 compared to a loss per diluted share of ($28.26) a year ago, an increase of $35.52, due to a prior year pre-tax charge of $8.1 billion expense accrual related to the opioid litigation.

Fourth-quarter Adjusted Earnings per Diluted Share was $5.83 compared to $5.05 a year ago, an increase of 15%, driven by growth across the business and a lower share count. Full-year Adjusted Earnings per Diluted Share was $23.69 compared to $17.21 a year ago, an increase of 38%, driven by strong operating performance across the segments, the contribution from COVID-19 vaccine distribution, kitting, and storage programs with the U.S. government, and a lower share count.

For the full-year, McKesson returned $3.8 billion of cash to shareholders, which included $3.5 billion of common stock repurchases and $277 million of dividend payments. During the fiscal year, McKesson generated cash from operations of $4.4 billion, and invested $535 million in capital expenditures, resulting in Free Cash Flow of $3.9 billion.

Business Highlights

In fiscal 2022, McKesson announced a planned exit from the European market, exemplifying its commitment to streamline the business and prioritizing investments in areas that are central to the long-term growth strategy.
On July 7, 2021, McKesson announced an agreement to sell certain McKesson Europe businesses in France, Italy, Ireland, Portugal, Belgium, and Slovenia to the PHOENIX Group. The transaction is expected to close in the second half of fiscal 2023.
On November 1, 2021, McKesson announced an agreement to sell its UK businesses to AURELIUS. The transaction closed on April 6, 2022.
On November 30, 2021, McKesson announced an agreement to sell the remaining share of its German joint venture to Walgreens Boots Alliance. The transaction closed on January 31, 2022.
On December 20, 2021, McKesson announced an agreement to sell its Austrian business to Quadrifolia Management GmbH. The transaction closed on January 31, 2022.
Norway and Denmark remain the only countries that McKesson has not entered into agreements to sell.
McKesson continued to expand its differentiated Oncology and Biopharma ecosystems, further demonstrating the significant progress against its company priorities.
McKesson’s proprietary oncology-focused software suite has documented approximately 10 million patient visits in the last year, helping to advance cancer care within the Oncology ecosystem.
Within the Biopharma ecosystem, McKesson helped patients save more than $6 billion on brand and specialty medications.
McKesson played a leading role in the fight against COVID-19. Through March 31, 2022:
U.S. Pharmaceutical successfully shipped over 380 million COVID-19 vaccines to administration sites across the U.S. and in support of the U.S. government’s international donation mission.
Medical-Surgical Solutions assembled enough kits to support the administration of more than 1.2 billion doses of COVID-19 vaccines.
Medical-Surgical Solutions distributed more than 135 million COVID-19 tests to physicians’ offices and other alternate healthcare sites.
U.S. Pharmaceutical Segment
Fourth-Quarter

Revenues were $53.7 billion, an increase of 14%, driven by increased volume of specialty products, including higher volumes from retail national account customers, and market growth, partially offset by branded to generic conversions.
Segment Operating Profit was $693 million. Adjusted Segment Operating Profit was $780 million, a decrease of 4%, driven by lower demand of COVID-19 vaccine distribution, partially offset by growth in distribution of specialty products to providers and health systems. Excluding the impact of COVID-19 vaccine distribution, the U.S. Pharmaceutical segment delivered Adjusted Segment Operating Profit growth of 2%.
Full-Year

Revenues were $212.1 billion, an increase of 12%, driven by increased volumes of specialty products, including higher volumes from retail national account customers, and market growth, partially offset by branded to generic conversions.
Segment Operating Profit was $2.9 billion. Adjusted Segment Operating Profit was $2.9 billion, an increase of 8%, driven by growth in distribution of specialty products to providers and health systems and contribution from COVID-19 vaccine distribution.
Prescription Technology Solutions Segment
Fourth-Quarter

Revenues were $1.0 billion, an increase of 29%, driven by volume growth related to biopharma services, including third-party logistics services and increased technology service revenue, partially resulting from the growth of prescription volumes.
Segment Operating Profit was $139 million. Adjusted Segment Operating Profit was $162 million, an increase of 11%, driven by growth from access and adherence solutions.
Full-Year

Revenues were $3.9 billion, an increase of 34%, driven by volume growth related to biopharma services, including third-party logistics services and increased technology service revenue.
Segment Operating Profit was $500 million. Adjusted Segment Operating Profit was $590 million, an increase of 26%, driven by growth from access and adherence solutions.
Medical-Surgical Solutions Segment
Fourth-Quarter

Revenues were $2.9 billion, an increase of 6%, driven by growth and improvements in the primary care business.
Segment Operating Profit was $280 million. Adjusted Segment Operating Profit was $298 million, an increase of 55%, driven by prior year inventory charges on PPE and related products as well as growth and improvements in the primary care business.
Full-Year

Revenues were $11.6 billion, an increase of 15%, driven by growth and improvements in the primary care business and the contribution from kitting, storage, and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program.
Segment Operating Profit was $959 million. Adjusted Segment Operating Profit was $1.2 billion, an increase of 50%, driven by growth and improvements in the primary care business, prior year inventory charges on PPE and related products, and the contribution from kitting, storage, and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program, partially offset by increased labor expenses.
International Segment
Fourth-Quarter

Revenues were $8.5 billion. On an FX-Adjusted basis, revenues were $8.8 billion, an increase of 3%, driven by the sales to new customers in the Canadian business and year-over-year volume recovery from COVID-19, partially offset by the divestiture of McKesson’s Austrian business, which was closed during the fourth quarter of fiscal 2022.
Segment Operating Loss was $207 million. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $152 million, an increase of 10%, driven by the reduction of depreciation and amortization on European assets under agreements to sell and increased volumes in the pharmaceutical distribution business, including COVID-19 vaccines, tests, and PPE.
Full-Year

Revenues were $36.3 billion. On an FX-Adjusted basis, revenues were $35.4 billion, a decrease of 2%, driven by the contribution of McKesson’s German pharmaceutical wholesale business to a joint venture with Walgreens Boots Alliance, partially offset by year-over-year volume recovery from COVID-19 and sales to new customers in the Canadian business.
Segment Operating Loss was $968 million. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $681 million, an increase of 40%, driven by increased volumes in the pharmaceutical distribution business, including COVID-19 vaccines, tests, and PPE, and the reduction of depreciation and amortization on European assets under agreements to sell.
Corporate Responsibility Updates

On February 25, 2022, McKesson announced the approval of the proposed opioid settlement agreement with 46 of 49 eligible states, as well as the District of Columbia and all eligible territories.
McKesson accomplished a significant refresh of the Board of Directors in fiscal 2022:
McKesson completed a smooth transition as Donald R. Knauss became independent chair of McKesson’s Board of Directors on April 1, 2022.
W. Roy Dunbar joined McKesson’s Board of Directors as a new director and member of the Audit and Governance Committees effective April 1, 2022.
James H. Hinton joined McKesson’s Board of Directors as a new director and member of the Compliance and Governance Committees effective January 13, 2022.
Kathleen Wilson-Thompson joined McKesson’s Board of Directors as a new director and member of the Compensation and Governance Committees effective January 13, 2022.
Dr. Richard H. Carmona joined McKesson’s Board of Directors as an independent director and member of the Compensation and Compliance Committees effective September 6, 2021.
McKesson received multiple awards and acknowledgements for its diversity, equity, and inclusion achievements. McKesson continues to build a diverse workplace by expanding representation of women and people of color in leadership roles.
McKesson submitted science-based targets to the Science Based Targets initiative (SBTi) for official validation in fourth quarter fiscal 2022. McKesson remains committed to establishing science-based greenhouse gas emissions reduction targets that are intended to meet SBTi’s standards.
Fiscal 2023 Outlook
McKesson continues its focused execution on company priorities including its planned exit from the European market. For fiscal 2023, McKesson expects Adjusted Earnings per Diluted Share of $22.90 to $23.60 to reflect continued operating momentum and a balanced approach to capital deployment.

Fiscal 2023 Adjusted Earnings per Diluted Share guidance includes approximately $0.20 to $0.60 of impacts attributable to the following:

$0.05 to $0.25 related to the U.S. government’s COVID-19 vaccine distribution, kitting, and storage programs; and $0.15 to $0.35 related to COVID-19 tests.

Fiscal 2023 Adjusted Earnings per Diluted Share guidance excluding the impacts of the above items from both fiscal 2023 guidance and fiscal 2022 results and $0.47 related to net gains associated with McKesson Ventures’ equity investments in fiscal 2022, indicates 9% to 14% forecasted growth compared to prior year.

Additional modeling considerations will be provided in the earnings call presentation.

Conference Call Details
McKesson has scheduled a conference call for today, Thursday, May 5th at 4:30 PM ET to discuss the company’s financial results. The audio webcast of the conference call will be available live and archived on McKesson’s Investor Relations website at investor.mckesson.com.

Upcoming Investor Events
McKesson management will be participating in the following investor conference:

Bank of America Healthcare Conference, May 12, 2022
Audio webcast, and a complete listing of upcoming events for the investment community, including details and updates, will be available on McKesson’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 Loss on Debt Extinguishment, 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.

On May 5, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported financial results for the quarter ended March 31, 2022, and highlighted recent progress (Press release, Elevation Oncology, MAY 5, 2022, View Source [SID1234613615]).

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!

"CRESTONE is an important study for both Elevation Oncology and for patients with NRG1 fusions, a genomically defined patient population with no approved therapies addressing the unmet medical need. We are honored for the opportunity to share the initial and first ever clinical data of seribantumab in this patient population through an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting in June 2022." said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "In addition to executing on CRESTONE, we are building an industry-leading team, led by people like Dr. David Dornan, our newly appointed Chief Scientific Officer, who brings a wealth of cancer drug development experience to advance our mission of maximizing the potential of seribantumab and building out an industry-leading precision oncology pipeline. Together with our diagnostic and academic partners, we look forward to advancing the field of precision oncology by expanding upon our operational platform and continuing to make genomic testing results therapeutically actionable."

Recent Progress and Highlights

Seribantumab

●Initial CRESTONE data selected for oral presentation at ASCO (Free ASCO Whitepaper) 2022. ASCO (Free ASCO Whitepaper) abstracts to be published on May 26, 2022 at 5:00PM ET. The presentation, scheduled for June 7, 2022, from 9:45AM-12:45PM CT, will highlight initial clinical data from approximately 10 patients from Cohort 1 in the ongoing Phase 2 CRESTONE study evaluating seribantumab at 3 grams weekly in patients with solid tumors harboring NRG1 gene fusions.

Corporate

●David Dornan, PhD appointed Chief Scientific Officer. In March, Elevation Oncology announced the appointment of Dr. Dornan, PhD, as the Company’s first Chief Scientific Officer, bringing deep oncology R&D and drug development expertise and further strengthening the leadership team.
Expected Upcoming Milestones and Operational Objectives

●Initial Phase 2 CRESTONE data to be presented in an oral presentation at ASCO (Free ASCO Whitepaper) 2022.
●Complete enrollment of the first 20 patients in Cohort 1 of the CRESTONE study in mid-2022.
●Ongoing target evaluation and continued execution of our strategy for future pipeline expansion.
First Quarter 2022 Financial Results

As of March 31, 2022, the Company had cash, cash equivalents and marketable securities totaling $132.1 million, compared to $146.3 million as of December 31, 2021.

Research and development expenses for the first quarter 2022 were $13.6 million, compared to $4.1 million for the first quarter 2021. The increase in R&D expense was primarily related to an increase in manufacturing, personnel costs and other expenses associated with the CRESTONE study.

General and administrative expenses for the first quarter 2022 were $3.8 million, compared to $1.0 million for the first quarter 2021. The increase in G&A expense was primarily related to personnel costs, professional services and other administrative costs.

Net loss for the first quarter 2022 was $17.3 million, compared to $5.1 million for the first quarter 2021.

Financial Outlook

Elevation Oncology expects its existing cash, cash equivalents and marketable securities as of March 31, 2022 will be sufficient to fund its current operations into the fourth quarter of 2023.

About Seribantumab and NRG1 Gene Fusions

Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins." The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation. Importantly, NRG1 gene fusions are predominantly mutually exclusive of other known genomic driver mutations and are considered a unique oncogenic driver event associated with tumor cell survival.

NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas. In preclinical experiments, seribantumab prevented the activation of HER3 signaling in cells that harbor an NRG1 gene fusion and destabilized the entire ERBB family signaling pathway, including the activation of HER2, EGFR, and HER4. In addition to extensive nonclinical characterization and testing, seribantumab has been administered to more than 800 patients across twelve Phase 1 and 2 studies, both as a monotherapy and in combination with various anti-cancer therapies. Seribantumab is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

About the Phase 2 CRESTONE Study

Clinical Study of Response to Seribantumab in Tumors with Neuregulin-1 (NRG1) Fusions (CRESTONE) is a Phase 2 tumor-agnostic "basket trial" evaluating the safety and efficacy of seribantumab in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The primary objective of the study is to describe the anti-tumor activity and safety of seribantumab as a monotherapy specifically in patients whose solid tumor is uniquely driven by an NRG1 gene fusion. CRESTONE offers a clinical trial opportunity for patients with advanced solid tumors who have not responded or are no longer responding to treatment. Patients are encouraged to talk to their doctor about genomic testing of their tumor. CRESTONE is open and enrolling patients in the United States, Australia, and Canada. For more information visit www.NRG1fusion.com.

On May 5, 2022 NKGen Biotech Inc., a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, reported an upcoming oral presentation on its NK cell therapy (SNK01) at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting, which will take place in Washington, D.C. from May 16 – 19, 2022 (Press release, NKGEN Biotech, MAY 5, 2022, View Source [SID1234613644]).

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!

Oral Presentation Details

Presentation Title: Consistent Expansion and Activation of Autologous Non-genetically Modified Natural Killer Cells with Enhanced Cytotoxicity (SNK01) from Heavily Pre-treated Patients with Advanced Solid Tumors

Presenting Author: Paul Y. Song, MD

Session Type: Oral Abstract

Session Title: Harnessing Innate Immunity for Cancer Immunotherapy

Location: Room 102 A/B

Date & Time: Wednesday May 18, 2022, 4:15 – 4:30 pm EDT

Abstract Number: 842

Full abstracts are available on the ASGCT (Free ASGCT Whitepaper) conference website View Source

On May 5, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported financial results for the first quarter 2022, recent business highlights and key upcoming catalysts (Press release, Atara Biotherapeutics, MAY 5, 2022, View Source [SID1234613659]).

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!

"Atara is off to a strong start in 2022, and we look forward to the upcoming interim analysis of our ATA188 Phase 2 study. With compelling Phase 1 data, two Fast Track designations, and validated groundbreaking science, ATA188 has the potential to transform treatment in progressive forms of MS with high unmet need and limited options," said Pascal Touchon, President and Chief Executive Officer of Atara. "We have also commenced our strategic manufacturing partnership with FUJIFILM Diosynth Biotechnologies, continue to progress tab-cel with EMA’s review in Europe and further engagement with FDA, and anticipate IND filings for our innovative CAR T programs later this year."

ATA188 for Progressive Multiple Sclerosis (MS)

Atara is on track to conduct a formal interim analysis (IA) of the Phase 2 EMBOLD study, planned for June 2022, to include efficacy, safety, and biomarker data to further inform our development strategy
A key data point at the time of IA will be expanded disability status scale (EDSS) improvement at six months, for applicable patients which, based on Phase 1 data, is >85% predictive of achieving confirmed EDSS improvement at 12 months, the FDA-validated primary endpoint of EMBOLD
This IA will also include EDSS improvement beyond six months for patients with longer treatment duration, other clinical endpoints, imaging biomarkers like magnetization transfer ratio (MTR) and biologic biomarkers
Results of the IA will determine whether any sample size adjustments are needed to optimize the likelihood of success in Phase 2 and best inform Phase 3 design and planning
After the IA is conducted, Atara plans to communicate next steps for the program in July 2022, including rationale, while still maintaining the integrity of the study
With the recent granting of Fast Track designation to ATA188 for non-active primary progressive multiple sclerosis (PPMS) and non-active secondary progressive multiple sclerosis (SPMS) by the FDA, we also then plan to meet with the FDA following the IA to share the data and to discuss next steps for the development pathway
Atara continues to advance enrollment in the Phase 2 EMBOLD study, with target enrollment of 80 patients expected soon after conducting the IA
Landmark studies in Nature and Science continue to drive significant interest and awareness of EBV as the trigger of MS
Momentum around ATA188 continues to build, marked by Atara’s successful EBV and MS Day where updated Phase 1 and open-label extension (OLE) data demonstrated that 20 out of 24 patients have had either EDSS improvement or EDSS stability throughout their observation in the study with up to 42 months follow-up. Overall, 33% of patients in the high-dose cohorts achieved confirmed EDSS improvement at the 12-month timepoint
Tabelecleucel (tab-cel) for Post-Transplant Lymphoproliferative Disease (PTLD)

The European Medicines Agency (EMA) review of tab-cel is progressing well and Atara anticipates European Commission (EC) approval in Q4 2022
The EMA has transitioned tab-cel to a standard assessment as Atara was informed that additional time was needed to adequately review the Company’s responses to EMA questions. Atara does not expect an impact to the anticipated EC approval timeframe
Atara remains in active dialogue with the FDA and has made further progress on discussing proposals to enable potential filing of the BLA that do not require a new Phase 3 clinical study
Proposals reflect tab-cel clinical and commercial product data generated to date, its status as a Breakthrough Therapy Designation product that addresses an urgent medical need, and its potential to save the lives of patients with an ultra-rare, often fatal disease with no approved therapeutic options
Tab-cel for Potential Additional Indications

The multi-cohort Phase 2 study evaluating tab-cel in six additional patient populations for EBV+ immunodeficiency-associated lymphoproliferative diseases (IA-LPDs) and other EBV-driven diseases continues to enroll in the U.S. and EU
First data from the multi-cohort study is on track for presentation in 2023
CAR T Programs

ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)

The global strategic collaboration for autologous ATA2271 and allogeneic ATA3271 with Bayer continues to progress
In February 2022, Memorial Sloan Kettering Cancer Center (MSK) notified the FDA of a fatal serious adverse event (SAE) in a patient treated in the third, higher dose cohort in the ongoing Phase 1, MSK-conducted and investigator led dose-escalation clinical study of autologous mesothelin CAR T, ATA2271
Per protocol, MSK voluntarily paused enrollment of new patients in the study on a temporary basis while additional information regarding the case is gathered and reviewed
Autopsy and additional data are still being analyzed by MSK
As is typical, we expect MSK will share autopsy and other results with FDA when ready, in addition to any intended informed consent and/or study protocol amendments
Atara and MSK expect to provide a Phase 1 data update for ATA2271 in H2 2022
IND-enabling work for ATA3271, our off-the-shelf, allogeneic CAR-T therapy targeting mesothelin using next-generation PD-1 DNR and 1XX CAR technologies for patients with advanced mesothelioma, is advancing, with the IND filing anticipated in Q4 2022
ATA3219 (B-cell Malignancies)

Atara continues to progress ATA3219, a potential best-in-class, allogeneic CAR T for B cell malignancies expressing CD19
Atara is on track to submit an IND in Q4 2022
ATA3219 is an optimized approach to address high unmet medical need, leveraging our next-generation 1XX CAR co-stimulatory signaling domain and allogeneic EBV T-cell platform and does not require TCR or human leukocyte antigen (HLA) gene editing
Allogeneic T-Cell Platform Manufacturing and Operations

In April 2022, Atara announced the appointment of Charlene Banard as Chief Technical Officer, who will oversee process science and development, quality, manufacturing and supply, further validating Atara’s advanced technology and its potential to transform the lives of patients with serious diseases
In April 2022, Atara announced the completion of the sale of its cell therapy manufacturing facility for USD 100 million upfront and the commencement of a long-term strategic manufacturing partnership with FUJIFILM Diosynth Biotechnologies (FDB)
With the closing of the transaction, FDB provides Atara with access to the flexible capacity and specific capability needed to manufacture clinical and commercial-stage allogeneic cell therapies for its maturing and promising pipeline, including tab-cel, ATA188 for multiple sclerosis, and allogeneic CAR T therapies, ATA3271 and ATA3219
The agreement is expected to reduce Atara’s planned operating expenses over the multi-year partnership period
Atara has retained a talented Technical Operations team who will continue to manage external manufacturing partnerships, manufacturing process science & development, quality assurance, supply chain, and logistics. Atara’s Thousand Oaks-based Atara Research Center (ARC) now houses Atara’s pre-clinical, translational sciences, manufacturing process sciences, and analytical development teams to further drive innovation by leveraging our unique and differentiated allogeneic cell therapy platform
First Quarter 2022 Financial Results

Cash, cash equivalents and short-term investments as of March 31, 2022, totaled $301.8 million, as compared to $371.1 million as of December 31, 2021; the amount as of March 31, 2022, excludes the $100.0 million upfront received from FDB in April
The March 31, 2022, cash balance includes $20.5 million of net proceeds from the sale of 1,319,878 shares of common stock through the Company’s ATM facilities in the first quarter
Atara believes that its cash as of March 31, 2022, together with the $100.0 million received from FDB on April 4, 2022, will be sufficient to fund the Company’s planned operations into the fourth quarter of 2023
Net cash used in operating activities was $84.5 million for the first quarter 2022, as compared to $65.7 million for the same period in 2021
Atara reported net losses of $88.1 million, or $0.87 per share for the first quarter 2022, as compared to $78.3 million, or $0.86 per share for the same period in 2021
Total operating expenses include non-cash expenses of $15.9 million for the first quarter 2022, as compared to $14.5 million for the same period in 2021
Research and development expenses were $75.0 million for the first quarter 2022, as compared to $64.1 million for the same period in 2021
The increases in the first quarter 2022 were primarily due to higher employee-related and overhead costs from increased headcount in support of continuing expansion of research and development activities and increased spending on research, development, and clinical trial costs related to the ATA188 program
Research and development expenses include $8.5 million of non-cash stock-based compensation expenses for the first quarter 2022 as compared to $7.5 million for the same period in 2021
General and administrative expenses were $20.6 million for the first quarter 2022, as compared to $17.7 million for the same period in 2021
The increases in the first quarter 2022 were primarily due to higher compensation-related costs from increased headcount
General and administrative expenses include $5.8 million of non-cash stock-based compensation expenses for the first quarter 2022, as compared to $4.7 million for the same period in 2021
Conference Call and Webcast Details
Atara will host a live conference call and webcast today, Thursday, May 5, 2022, at 4:30 p.m. EDT to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13728000. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of atarabio.com. An archived replay will be available on the Company’s website for 30 days following the live webcast.

On May 5, 2022 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Jounce Therapeutics, MAY 5, 2022, View Source [SID1234613675]).

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!

"Jounce made significant progress this quarter as we focused on the continued advancement of our two proof of concept studies, INNATE and SELECT, in addition to advancing candidates from our discovery engine, such as JTX-1484, our LILRB4 (or ILT3) inhibitor. With our cash runway extending beyond our key inflection points, we are poised for an important second half of this year," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "I’m very pleased to share that we recently met the prespecified response criteria in two combination cohorts to continue the Phase 2 expansion in the INNATE trial, and, in our SELECT trial, we have achieved target enrollment. These achievements represent significant progress in building our pipeline of diverse immunotherapy candidates. We continue to focus on our mission of delivering meaningful and long-lasting benefit to cancer patients through the discovery and pursuit of therapies that target new mechanisms of immune suppression across different types of immune cells, and bringing the right immunotherapies to the right patients."

Pipeline Update & Highlights:
JTX-8064 (LILRB2/ILT4)

Expanded two of seven combination cohorts in INNATE Phase 2 trial. Jounce is evaluating JTX-8064 in the ongoing Phase 2 portion of the INNATE clinical trial, which is comprised of indication specific expansion cohorts, including one monotherapy cohort and seven combination therapy cohorts. Each cohort is a Simon 2-stage design, in which we enroll 10 patients, wait for initial response data, and then further expand to a total of 29 patients if prespecified response criteria are met. Today, Jounce is announcing that the first two combination cohorts have met their response criteria for expansion within INNATE and are now continuing enrollment to 29 patients each. Jounce has seen an acceptable safety profile for both the monotherapy and combination therapy to date.

On track to report preliminary clinical data in the second half of 2022. The INNATE clinical trial is studying three distinct patient populations across the 7 indications: (1) PD-1 inhibitor naïve patients with tumors for which there are approved PD-1 or PD-L1 inhibitors, (2) PD-(L)1 inhibitor naïve patients who have tumors for which there are no PD-1 or PD-L1 inhibitors approved and (3) patients who were previously treated with a PD-1 inhibitor and are PD-1 inhibitor resistant. Jounce remains on track to report preliminary clinical data, including all 31 dose escalation patients and at least 60 Phase 2 patients from INNATE, in the second half of 2022.
Vopratelimab (ICOS) and Pimivalimab (PD-1)

Patient screening finished in the Phase 2 SELECT trial of vopratelimab. Patient screening is complete with the target enrollment of at least 60 evaluable patients having been met in SELECT, a randomized Phase 2 trial evaluating vopratelimab in combination with pimivalimab versus pimivalimab alone in immunotherapy naïve, TISvopra biomarker-selected, second line non-small cell lung cancer (NSCLC) patients. Jounce is on track to report data from the SELECT trial in the second half of 2022, including additional single agent data for pimivalimab.
JTX-1484 (LILRB4/ILT3)

JTX-1484 is the most recent product candidate to emerge from our Translational Science Platform. JTX-1484 is a monoclonal antibody designed to block human LILRB4 expressed on myeloid cells in the tumor microenvironment with the potential to reduce immune suppression and enhance T cell functionality. JTX-1484 is currently in IND-enabling activities, with the goal of filing an investigational new drug application ("IND") in 2023.
Discovery Pipeline

Productive discovery engine with the goal of an IND every 12 to 18 months: Jounce continues to invest in and advance its growing immuno-oncology pipeline. Its discovery engine is built upon the capability to thoroughly interrogate different cell types in the tumor microenvironment, including T cells and myeloid cells. This approach has resulted in four clinical stage programs, with a fifth in IND enabling studies, over the last 6 years.
First Quarter 2022 Financial Results:

Cash position: As of March 31, 2022, cash, cash equivalents and investments decreased to $186.4 million, compared to $220.2 million as of December 31, 2021. The decrease was due to operating expenses incurred during the period.
License and collaboration revenue: Jounce did not recognize any revenue during the first quarter of 2022. License and collaboration revenue of $1.5 million was recognized during the first quarter of 2021 and was comprised solely of non-cash revenue related to the performance of research and transition services under the Gilead License Agreement.
Research and development expenses: Research and development expenses were $30.1 million for the first quarter of 2022, compared to $20.5 million for the same period in 2021. The increase in research and development expenses was primarily due to increased manufacturing activities performed for Jounce’s development programs, increased clinical and regulatory costs for INNATE, and increased payroll and stock-based compensation expense.
General and administrative expenses: General and administrative expenses were $7.3 million for the first quarter of 2022, compared to $7.6 million for the same period in 2021. The decrease in general and administrative expenses was primarily due to decreased external consulting and stock-based compensation expense.
Net loss: Net loss was $37.4 million for the first quarter of 2022, resulting in basic and diluted net loss per share of $0.72. Net loss was $26.5 million for the same period in 2021, resulting in a basic and diluted net loss per share of $0.58. The increase in net loss was primarily attributable to increased operating expenses incurred during the first quarter of 2022.
Financial Guidance:
Based on its current operating and development plans, Jounce reiterates its financial guidance for 2022. Gross cash burn on operating expenses and capital expenditures for the full year 2022 is expected to be approximately $115.0 million to $130.0 million. Given the strength of its balance sheet, Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements through the third quarter of 2023.

Conference Call and Webcast Information:
Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 9072989. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.