Mersana Therapeutics Provides Business Update and Announces First Quarter 2022 Financial Results

On May 9, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported financial results for the first quarter ended March 31, 2022 (Press release, Mersana Therapeutics, MAY 9, 2022, View Source [SID1234613940]).

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"We believe that UpRi holds the potential to transform the treatment paradigm for patients with ovarian cancer. Our development strategy is designed to advance UpRi from platinum-resistant ovarian cancer with our potential UPLIFT data readout in 2023 into earlier lines of treatment with our UP-NEXT and UPGRADE trials," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "With a strengthened balance sheet and preparations to move XMT-1660 and XMT-2056 into the clinic in the near term, we look forward to delivering clinical data across all three of our platforms and building a leading ADC company."

Strategic Goals, Recent Developments and Anticipated Milestones

Build UpRi, a Dolaflexin ADC targeting NaPi2b, into a Foundational Medicine in Ovarian Cancer:
Presented Analysis Supporting UPLIFT Trial Dose: An analysis from nearly 100 patients in the expansion cohort of the Phase 1 Upifitamab Rilsodotin (UpRi) clinical trial based on a June 10, 2021 data cut was presented at the 2022 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer. This analysis supported the decision to select 36mg/m2 as the dose for UPLIFT, given the observed efficacy in both the evaluable and intent to treat populations, fewer adverse events (AEs) including Grade 3 or higher AEs, longer duration of treatment, and fewer discontinuations relative to the higher dose group.
Expecting to Complete Enrollment in UPLIFT Registration Trial in 3Q 2022: UPLIFT is enrolling up to 180 patients with platinum-resistant ovarian cancer, including approximately 100 patients with high NaPi2b expression. The trial’s primary endpoint will evaluate efficacy in the NaPi2b high population.
Advancing Toward Initiation of Patient Screening in UP-NEXT Trial in 2Q 2022: UP-NEXT is a Phase 3 clinical trial of UpRi as monotherapy maintenance following treatment with platinum doublets in recurrent platinum-sensitive ovarian cancer. This trial has the potential to serve as a post-approval confirmatory trial, supporting the expansion of UpRi into earlier lines of therapy.
Enrolling UPGRADE Combination Trial: UPGRADE, the company’s Phase 1/2 umbrella trial of UpRi in combination with other agents, is currently dose escalating UpRi in combination with carboplatin. Mersana expects to disclose interim data from this cohort in Q4 2022, with a primary focus on safety and tolerability. UPGRADE is intended to inform the further development of UpRi in combination with other therapies used in platinum-sensitive ovarian cancer.
Build Out Pipeline of Highly Impactful Cancer Medicines
Planning to Initiate Phase 1 Clinical Trial of XMT-1660 in Mid-2022: XMT-1660 is a B7-H4-directed Dolasynthen ADC with a precise and target-optimized drug-to-antibody ratio (DAR) of 6 and Mersana’s clinically validated DolaLock microtubule inhibitor payload with controlled bystander effect. In April, the company presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating that a single dose of XMT-1660 had anti-tumor activity in xenograft models of both triple-negative breast cancer and estrogen receptor positive breast cancer. The data presented also demonstrated that higher B7-H4 expression was associated with greater anti-tumor activity of XMT-1660, consistent with its targeted effect. In its Phase 1 clinical trial, the company expects to investigate XMT-1660 in B7-H4-expressing tumors such as breast, endometrial and ovarian cancers.
Planning to Initiate Phase 1 Clinical Trial of XMT-2056 in Mid-2022: XMT-2056, the company’s first Immunosynthen STING agonist ADC, targets a novel epitope of HER2 and is designed to offer a differentiated and complementary therapeutic approach to existing and emerging solid tumor treatments. In April, the company presented preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting demonstrating that XMT-2056 had robust anti-tumor activity as a monotherapy in both high and low HER-2 expressing models. The data showed XMT-2056’s complementary mechanism of action also resulted in increased efficacy across a number of models in combination with trastuzumab, pertuzumab, anti-PD-1 and trastuzumab deruxtecan. In its Phase 1 clinical trial, the company expects to investigate XMT-2056 in HER2-expressing tumors such as breast, gastric and non-small-cell lung cancers.
Maintaining Pipeline Prioritization Discipline: Based on the lower prevalence of the NaPi2b biomarker in non-small cell lung cancer, the increasingly competitive nature of this indication and the company’s commitment to remain financially disciplined, Mersana has decided to discontinue the development of XMT-1592. Additionally, the company has decided to defer certain investments in its preclinical pipeline, including two of its earlier-stage candidates, XMT-2068 and XMT-2175.
Build Mersana with Strategic Partners:
Announced New Collaboration with Janssen: In February, the company announced a research collaboration and license agreement with Janssen Biotech, Inc. to discover novel ADCs for up to three targets by leveraging Mersana’s Dolasynthen platform and ADC expertise and Janssen’s antibodies. As part of the agreement, Mersana received a $40.0 million upfront payment and has the potential to receive more than $1.0 billion in total milestone payments and mid-single-digit to low-double-digit percentage royalties on future net sales.
First Quarter 2022 Financial Results

Net cash used in operating activities in the first quarter of 2022 was $8.0 million. Cash and cash equivalents as of March 31, 2022, were $230.1 million, compared to $177.9 million in cash and cash equivalents as of December 31, 2021. This increase reflects the receipt of the $40.0 million upfront payment from Janssen and proceeds from the sale of Mersana common stock through its at-the-market (ATM) equity offering program, partially offset by operating spend. The company expects that its available funds will be sufficient to support its operating plan commitments well into the second half of 2023.
Research and development (R&D) expenses for the first quarter of 2022 were $35.8 million, compared to $27.4 million for the same period in 2021. Included in first quarter 2022 R&D expenses was $2.9 million in non-cash stock-based compensation. The year-over-year increase in R&D expenses was primarily related to greater headcount, preparations for the clinical advancement of XMT-1660 and XMT-2056, and increased UpRi manufacturing and clinical costs.
General and administrative (G&A) expenses for the first quarter of 2022 were $12.8 million, compared to $7.2 million during the same period in 2021. Included in first quarter 2022 G&A expenses was $2.6 million in non-cash stock-based compensation. The year-over-year increase in G&A expenses was primarily related to an increase in consulting and professional fees, and increased headcount.
Net loss for the first quarter of 2022 was $47.3 million, or $0.59 per share, compared to a net loss of $34.7 million, or $0.50 per share, for the same period in 2021.
Conference Call Reminder
Mersana will host a conference call today at 8:00 a.m. ET to discuss its financial results for the first quarter of 2022 and business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 4289737. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for at least 90 days.

Surface Oncology Reports Financial Results and Corporate Highlights for First Quarter 2022

On May 9, 2022 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the first quarter of 2022 as well as upcoming anticipated corporate milestones (Press release, Surface Oncology, MAY 9, 2022, View Source [SID1234613939]).

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"The first quarter of 2022 marked the beginning of a data-rich year for Surface, starting with the presentation of preclinical and translational SRF388 data at AACR (Free AACR Whitepaper) in April," said Rob Ross, M.D., chief executive officer. "We are actively developing two novel antibodies in Phase 2 studies, SRF388 and SRF617, and our runway now provides us with 12 months of cash beyond data readouts for up to six different indications and combination studies across the programs. We look forward to presenting our next update on SRF388, the only antibody targeting IL-27 in the clinic, at ASCO (Free ASCO Whitepaper), and we remain on track to share new clinical data for SRF617 in the second half of this year."

First Quarter and Subsequent Corporate Highlights

During the first quarter, Surface raised net proceeds of approximately $21 million through the company’s existing At-the-Market (ATM) facility with participation based on unsolicited interest received from EcoR1 and Octagon Capital Advisors.

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, Surface presented SRF388 preclinical and translational data supporting the recommended Phase 2 monotherapy dose selection of 10 mg/kg administered intravenously every four weeks. This dose is being studied in dedicated expansion cohorts of treatment-refractory clear cell renal cell carcinoma (ccRCC), non-small-cell lung cancer (NSCLC), and hepatocellular carcinoma (HCC).

In March, Surface announced that the first patient had been dosed by GlaxoSmithKline (GSK) in a Phase 1 study evaluating GSK4381562 in patients with solid tumors. GSK4381562 is a fully human IgG1 antibody targeting PVRIG, an inhibitory protein on the TIGIT/DNAM/TACTILE axis that is expressed on natural killer cells (NK cells) and T cells. As a result, Surface is entitled to a $30 million milestone payment and is eligible to receive an additional $700 million in potential future milestone payments, and tiered royalties on global net sales.

In March, the company announced the appointment of Theresa Boni, J.D., as general counsel and senior vice president, legal. Ms. Boni brings more than 20 years of legal experience spanning the biopharmaceutical and medical device industries.
SRF388 Clinical Trial Progress and Updates

In April 2022, Surface announced the initiation of two Phase 2 clinical studies evaluating SRF388, a potential first-in-class antibody against IL-27. The initiations include the first patient dosed in a Phase 2 monotherapy clinical study in treatment-refractory NSCLC patients and the first patient dosed in the lead-in to a randomized Phase 2 clinical study in combination with atezolizumab and bevacizumab in patients with HCC who have not received prior systemic treatment (first-line).

With respect to the design of the SRF388 randomized Phase 2 study in first-line HCC, the company will expand the open-label lead-in from six patients, as originally planned, to approximately 30 patients. Management believes this expanded lead-in will provide more robust safety and efficacy data to inform the start of the randomized stage and could elucidate important biomarkers to support enriched patient selection. Data from the lead-in are anticipated in the first half of 2023.

New clinical data on SRF388 will be presented in an oral session at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. The session, entitled "First-in-human study of SRF388, a first-in-class IL-27 targeting antibody, as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors," will be held Saturday, June 4, 2022, from 1:15 pm – 4:15 pm CDT.
Selected Anticipated Near-term Corporate Milestones

The company remains on track to provide a clinical data update on SRF617, a fully human antibody designed to inhibit CD39, in the second half of 2022.

Surface anticipates filing an Investigational New Drug application for SRF114, a fully human IgG1 anti-CCR8 antibody, in the second half of 2022.
Financial Results
As of March 31, 2022, cash, cash equivalents and marketable securities were $150.4 million, compared to $154.1 million on December 31, 2021.

General and administrative (G&A) expenses were $6.5 million for the first quarter ended March 31, 2022, compared to $5.6 million for the same period in 2021. This increase was primarily due to increases in personnel and facility-related costs and increased insurance premiums. G&A expenses included $1.3 million in stock-based compensation expense for the first quarter ended March 31, 2022.

Research and development (R&D) expenses were $16.6 million for the first quarter ended March 31, 2022, compared to $10.5 million for the same period in 2021. This increase was primarily driven by progress on our SRF617 and SRF388 Phase 1 clinical trials and advancement into Phase 2 trials. R&D expenses included $0.6 million in stock-based compensation expense for the first quarter ended March 31, 2022.

For the first quarter ended March 31, 2022, net income was $6.2 million, or basic net income per share of $0.13 and diluted net income per share of $0.13. Net loss was $15.6 million for the same period in 2021, or basic and diluted net loss per share of $0.37.

Based upon the current operating plan, Surface projects its cash runway extending into 2024.

Alkermes Announces Four Abstracts Accepted for Presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 9, 2022 Alkermes plc (Nasdaq: ALKS) reported the acceptance of four abstracts related to nemvaleukin alfa (nemvaleukin), the company’s novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 3-7, 2022 in Chicago and virtually (Press release, Alkermes, MAY 9, 2022, View Source [SID1234613938]). The final dataset from the phase 1/2 ARTISTRY-1 clinical trial, evaluating the safety, tolerability and efficacy of nemvaleukin administered intravenously as a monotherapy and in combination with pembrolizumab (KEYTRUDA), will be shared in an oral presentation. In addition, trial-in-progress posters from the ongoing ARTISTRY-3 trial and the potential registration-enabling studies ARTISTRY-6 and ARTISTRY-7 will be presented.

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Details of the presentations are as follows:
Oral Presentation
Abstract: 2500
Title: Nemvaleukin alfa monotherapy and in combination with pembrolizumab in patients (pts) with advanced solid tumors: ARTISTRY-1
Presenter: Ulka N. Vaishampayan, M.D., Professor, Internal Medicine, Division of Hematology/Oncology, University of Michigan
Presentation Session Date/Time: The oral presentation will take place on Saturday, June 4, 2022 from 1:15 – 4:15 p.m. CDT, during the session titled "Developmental Therapeutics—Immunotherapy"

Poster Presentations
Abstract: TPS5609
Title: ARTISTRY-7: A phase 3, multicenter study of nemvaleukin alfa in combination with pembrolizumab versus chemotherapy in patients (pts) with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
Presenter: Thomas J. Herzog, M.D., Professor of Obstetrics and Gynecology, Deputy Director, University of Cincinnati Cancer Institute and Associate Director of GOG Partners
Presentation Session Date/Time: The poster will be presented on Saturday, June 4, 2022 from 1:15 – 4:15 p.m. CDT, during the "Gynecologic Cancers" poster session

Abstract: TPS2684
Title: ARTISTRY-3: Effect of nemvaleukin alfa with a less frequent IV dosing schedule as monotherapy and in combination with pembrolizumab and impact on the tumor microenvironment (TME) in patients (pts) with advanced solid tumors
Presenter: Sarina A. Piha-Paul, M.D., Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center
Presentation Session Date/Time: The poster will be presented on Sunday, June 5, 2022 from 8:00 – 11:00 a.m. CDT, during the "Developmental Therapeutics—Immunotherapy" poster session

Abstract: TPS9609
Title: ARTISTRY-6: Nemvaleukin alfa monotherapy in patients with advanced mucosal and cutaneous melanoma
Presenter: Jeffrey S. Weber, M.D., Ph.D., Professor of Medicine, Deputy Director, Laura and Isaac Perlmutter Cancer Center, New York University School of Medicine
Presentation Session Date/Time: The poster will be presented on Monday, June 6, 2022 from 1:15 – 4:15 p.m. CDT, during the "Melanoma/Skin Cancers" poster session

About Nemvaleukin Alfa (nemvaleukin)
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by selectively binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials in the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3, ARTISTRY-6 and ARTISTRY-7.

Precision BioSciences Reports First Quarter 2022 Financial Results and Provides Business Update

On May 9, 2022 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Precision Biosciences, MAY 9, 2022, View Source [SID1234613937]).

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"We continue to focus on execution and build on the utility of ARCUS as a premier genome editing platform to develop novel treatments for cancer and genetic diseases. We believe the differentiated attributes of ARCUS enable a high degree of specificity, minimal levels of off-target editing and maximum versatility, including gene insertion. These qualities underpin our organic strategy and attract accomplished partners that extend our reach to more patients with serious diseases while also providing capital to advance our core development priorities," said Michael Amoroso, Chief Executive Officer at Precision BioSciences. "As our programs continue to mature, we will remain nimble and follow the data to prudently manage our portfolio. This will allow us to hone in on the most impactful approaches to develop potential allogeneic CAR T product candidates and pursue optimal strategies for delivery to various tissues for gene editing in vivo."

"As we look ahead, we plan to provide an update across our allogeneic CAR T programs in June 2022 as data matures. On the research front, we have initiated IND-enabling studies for PBGENE-PH1 delivered by LNP as we target advancing three wholly owned in vivo gene editing programs towards IND or CTA applications over the next three years," Mr. Amoroso continued.

Recent Developments and Upcoming Milestones:

Ex Vivo Allogeneic CAR T Portfolio:

PBCAR0191: PBCAR0191 is the Company’s lead investigational anti-CD19 allogeneic CAR T candidate being evaluated in a Phase 1/2a clinical trial of adult subjects with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL). In December 2021, Precision announced a Phase 1 data update, in which a 100% overall response rate (6/6) and a 66% complete response rate (4/6) was observed among patients that previously received an autologous CAR T therapy and progressed. Precision prioritized enrollment of this high unmet need patient population as a potential path for PBCAR0191, and the Company plans to provide a program update on PBCAR0191 in June 2022.
PBCAR19B: PBCAR19B is a novel, immune-evading stealth cell candidate employing a single-gene edit to knock-down beta-2 microglobulin and insert an HLA-E transgene. We believe PBCAR19B is the first CAR T cell candidate in the clinic designed to evade rejection by host T cells and natural killer (NK) cells. Precision initiated a clinical trial of PBCAR19B in patients with NHL in mid-2021 and plans to commence dosing in the third quarter of 2022 at the next dose level with clinical trial material from an optimized manufacturing process. The Company plans to provide a program update on PBCAR19B in June 2022.
PBCAR269A: PBCAR269A is an investigational allogeneic CAR T cell candidate targeting B-cell maturation antigen (BCMA) for R/R multiple myeloma. Precision is evaluating PBCAR269A in a Phase 1/2a study in combination with nirogacestat, a gamma secretase inhibitor developed by SpringWorks Therapeutics. The first patient was dosed in the combination arm in June 2021, and Precision expects to provide a program update on PBCAR269A in June 2022.
In Vivo Gene Editing Portfolio:

Over the next three years, Precision expects that three of its wholly owned preclinical in vivo programs will advance to IND or CTA. This includes:

PBGENE-PCSK9: In 2021, Precision initiated a collaboration with iECURE, pursuant to which Precision’s PBGENE-PCSK9 candidate is expected to advance through preclinical activities as well as a Phase 1 study in familial hypercholesterolemia. A CTA filing is expected as early as the end of 2022.
PBGENE-PH1: Precision has initiated IND-enabling activities for its PBGENE-PH1 candidate designed to knock out the well-validated HAO1 gene as a potential one-time treatment for primary hyperoxaluria type 1 (PH1). In the first quarter of 2022, the Company initiated a non-human primate study for PBGENE-PH1 delivered by LNP and expects to submit an IND or CTA in 2023.
PBGENE-HBV: Precision’s gene editing program for chronic Hepatitis B applies ARCUS to knock out persistent covalently closed circular DNA (cccDNA) and inactivate integrated hepatitis B genomes, potentially achieving durable HBV S-antigen (HBsAg) loss and viral persistence. Precision plans to pursue clinical development of its PBGENE-HBV candidate using LNP delivery and expects to submit an IND/CTA in 2024.
Precision continues its in vivo gene editing collaboration with Lilly and is applying ARCUS nucleases for three initial targets, including Duchenne muscular dystrophy in muscle, a central nervous system directed target and a liver directed target. In addition, Precision continues to engage discussions with potential biotech collaborators to leverage the unique attributes of ARCUS, such as gene insertion, for a variety of disease targets.

As announced on May 2, 2022, preclinical data on Precision’s wholly owned PH1 and HBV programs will be presented at the upcoming American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) meeting, May 16-19, 2022.

Abstract #239, Optimization of Hydroxyacid Oxidase 1 (HAO1) Targeting ARCUS Nucleases for the Treatment of Primary Hyperoxaluria Type 1
Abstract #447, Targeting the Hepatitis B cccDNA with a Sequence-Specific ARCUS Nuclease to Eliminate Hepatitis B Virus In Vivo
Other Research:

Additional abstracts on ARCUS in vivo gene editing have been accepted for presentation at the upcoming ASGCT (Free ASGCT Whitepaper) meeting, including one abstract on Precision’s mitochondrial DNA preclinical research and one abstract from a research and license collaboration with iECURE and the company’s ornithine transcarbamylase (OTC) deficiency program.

Abstract #561, ARCUS Gene Editing to Eliminate MELAS-associated m.3243A>G Mutant Mitochondrial DNA
Abstract #811, AAV-meganuclease-mediated Gene Targeting Achieves Efficient and Sustained Transduction in Newborn and Infant Macaque Liver
Preclinical research led by the Department of Ophthalmology and Visual Sciences at the University of Louisville using ARCUS genome editing platform for autosomal dominant Retinitis Pigmentosa (adRP) was presented at the recent Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

Abstract #3710318, Successful Late-stage Disease Treatment of P23H Human RHO (hRHO) Using ARCUS Nuclease Gene Editing in a Pig Model of Autosomal Dominant Retinitis Pigmentosa (adRP)
Abstract #3712152, Characterization of a Humanized Mouse Model of P23H Rhodopsin Autosomal Dominant Retinitis Pigmentosa (adRP)
Corporate:

Intellectual Property (IP) Update: In March 2022, the U.S. Patent and Trademark Office issued Precision five new U.S. patents further adding to the Company’s IP portfolio that cover the ARCUS platform and its use developing novel ex vivo and in vivo gene editing therapies. The five new patents included: patents relating to methods of using ARCUS nucleases to target sequences in the Hepatitis B virus (U.S. Patent No. 11,274,285); methods for modifying the Factor VIII gene in hemophilia A (U.S. Patent No. 11,278,632); methods for novel co-stimulatory domain used for allogeneic CAR T expansion (U.S. Patent No. 11,286,291); and methods of making allogeneic CAR T cells and T cell receptor alpha chain (TRAC)-targeting ARCUS nucleases useful in such methods (U.S. Patent Nos. 11,268,065 and 11,266,693).
Quarter Ended March 31, 2022 Financial Results:

Cash and Cash Equivalents: As of March 31, 2022, Precision had approximately $116.2 million in cash and cash equivalents. The Company expects that existing cash and cash equivalents, expected operational receipts and available credit will be sufficient to fund its operating expenses and capital expenditure requirements into mid-2023.

Revenues: Total revenues for the quarter ended March 31, 2022 were $3.3 million, as compared to $16.3 million for the same period in 2021. The decrease of $13.0 million in revenue during the quarter ended March 31, 2022 was primarily the result of a $10.3 million decrease in revenue recognized under the Servier Agreement subsequent to full satisfaction of the performance obligation under the execution of the Program Purchase Agreement in April 2021, a $2.1 million decrease in revenue recognized under the Lilly Agreement, and a $0.6 million decrease in revenue recognized from an agriculture partnering collaboration.

Research and Development Expenses: Research and development expenses were $20.0 million for the quarter ended March 31, 2022, as compared to $25.6 million for the same period in 2021. The decrease of $5.6 million was primarily due to decreases of $2.7 million in external development costs, including clinical research organization and clinical manufacturing organization costs, associated with our PBCAR0191, PBCAR269A, PBCAR20A and PBCAR19B clinical trials, as well as decreases of $1.1 million in sublicensing royalty payable to Duke on the Lilly upfront payment that was received in 2021 and $1.4 million in employee-related costs due to reduced headcount driven by the separation of Elo in 2021.

General and Administrative Expenses: General and administrative expenses were $10.7 million for the quarter ended March 31, 2022, as compared to $9.5 million for the same period in 2021. The increase of $1.2 million was primarily due to costs required to meet our growing infrastructure needs, including an increase of $1.3 million in general and administrative employee-related costs associated with increased wages, share-based compensation, relocation and recruiting costs for key management personnel.

Net Loss: Net loss was $28.2 million, or $(0.46) per share (basic and diluted), for the quarter ended March 31, 2022, as compared to a net loss of $18.7 million, or $(0.33) per share (basic and diluted), for the same period in 2021.

Labcorp Acquires Diagnostic Clinical Laboratory Services From AtlantiCare

On May 9, 2022 Labcorp (NYSE: LH), a leading global life sciences company, and AtlantiCare, the largest health care organization in southern New Jersey, reported that they have closed a transaction to expand their long-term strategic relationship (Press release, LabCorp, MAY 9, 2022, View Source [SID1234613936]). Labcorp will acquire select assets from AtlantiCare’s clinical outreach business, which serves the AtlantiCare Physician Group and Affiliated Physicians and their patients across southern New Jersey. The transaction is the latest in a series of new and expanded collaborations between Labcorp and health systems across the country, demonstrating the value that Labcorp brings to improve laboratory services and help enhance patient care.

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"Labcorp is keenly focused on delivering value to our health system partners, physicians, and the broader community," said Bill Haas, senior vice president of Labcorp’s Northeast Division. "Our multi-year, comprehensive relationship with AtlantiCare is a prime example of that focus. Through this enhanced outreach relationship, Labcorp is furthering its commitment to AtlantiCare’s patients and providers to improve health and improve lives in the region, including through increased diagnostic testing access."

AtlantiCare’s patients will be able to access Labcorp’s expansive test menu and services through the company’s extensive network of patient service centers including Labcorp at Walgreens. Many of AtlantiCare’s physician office phlebotomy sites and outpatient collection services will now be operated by Labcorp.

"As a health system, we are committed to evolving the care and services we provide," said Lori Herndon, MBA, BSN, RN, president and CEO of AtlantiCare. "Our past collaboration with Labcorp has helped us provide comprehensive testing services to meet the growing needs of our community. Most recently, this has included Labcorp’s ability to provide critical testing, collections, lab equipment and supplies throughout the pandemic. This collaboration will enhance the breadth and quality of laboratory services patients and healthcare providers have come to expect from both of our organizations."