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AbbVie and Scripps Research Announce Collaboration to Develop Antiviral Treatments for COVID-19

On March 15, 2022 AbbVie (NYSE: ABBV) and Scripps Research, an independent, non-profit biomedical research and drug discovery institute, reported a global collaboration to develop potential novel, direct-acting antiviral treatments for COVID-19 (Press release, AbbVie, MAR 15, 2022, View Source [SID1234610087]).

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"Constant change is something we’ve experienced throughout the COVID-19 pandemic, with the emergence of many new variants and the evolving needs of treatment options to combat more contagious, aggressive and severe strains of the virus," said Tom Hudson, M.D., senior vice president, R&D, chief scientific officer, AbbVie. "We are committed to bringing differentiated, next generation oral antiviral treatments to patients and ensuring broad access to address the diverse treatment needs around the world."

The initial SARS-CoV-2 research program at Calibr, the drug discovery and development division of Scripps Research, was supported by funding from the Bill & Melinda Gates Foundation.

"We believe our SARS-CoV-2 research program has the potential to impact significantly the ongoing gaps in patient needs to move from pandemic to endemic COVID-19," said Peter Schultz, Ph.D., president and chief executive officer, Scripps Research. "We are excited to partner with AbbVie who brings both the scientific expertise and the manufacturing capabilities to accelerate the development of this program."

Closing of the transaction remains subject to satisfaction of customary closing conditions, including applicable regulatory approvals.

RedHill and Kukbo Enter Oral Opaganib License for COVID-19 in South Korea

On March 15, 2022 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it has entered into an exclusive license agreement with Kukbo Co. Ltd. (Kospi: 001140) ("Kukbo"), a South Korean corporation, for oral opaganib1 for the treatment of COVID-19, in South Korea (Press release, RedHill Biopharma, MAR 15, 2022, View Source [SID1234610086]).

Under the terms of the license agreement, which follows the previously announced strategic investment by Kukbo, RedHill will receive an upfront payment of $1.5 million and is eligible for up to $5.6 million in milestone payments as well as low double-digit royalties on net sales of oral opaganib in South Korea. Kukbo will receive the exclusive rights to commercialize opaganib in South Korea for COVID-19.

Dror Ben-Asher, RedHill’s CEO, said: "South Korea is currently experiencing a spike in COVID-19 cases with the Korea Disease Control & Prevention Agency reporting almost 4 million new cases already registered in the first half of March alone. Together with our partner, Kukbo, we are working hard to bring opaganib to Korean patients in need of new COVID-19 therapeutic options."

"Every day this month we are seeing an average of almost 2000 people hospitalized due to COVID-19 in South Korea and we desperately need medications that can effectively treat these patients," said Hyun Ha, Kukbo’s CEO. "With the data supporting opaganib for COVID-19, and the expanded partnership with RedHill, Kukbo is determined to work with local regulators with the aim of bringing opaganib to South Korean patients, as soon as possible."

The partnership with Kukbo also includes a right of first offer for RedHill’s late-stage clinical assets, opaganib, RHB-107 (upamostat)2 and Talicia, for one or more of the territories of South Korea, Japan, Indonesia, Vietnam, Thailand and/or Malaysia. The right of first offer has been extended as part of the new license agreement until the end of October 2022.

About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with proposed dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

In prespecified analyses of Phase 2/3 clinical data, oral opaganib has demonstrated improved viral RNA clearance, significant mortality reduction on top of remdesivir and corticosteroids and faster time to recovery. Opaganib previously delivered promising U.S. Phase 2 data in patients with moderate to severe COVID-19, submitted for peer review and recently published in medRxiv.

Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Patient accrual, treatment and analysis in this study are ongoing.

Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of the original SARS-CoV-2 and variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib’s potential to decrease renal fibrosis, have shown decreased fatality rates from influenza virus infection, and amelioration of bacteria-induced pneumonia lung injury with reduced levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids3.

The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

Cogent Biosciences Provides Corporate Updates, Fourth Quarter and Full Year 2021 Financial Results

On March 15, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported financial results for the fourth quarter and year ended December 31, 2021 (Press release, Unum Therapeutics, MAR 15, 2022, View Source [SID1234610076]).

"In 2021, Cogent achieved substantial progress toward our goal of establishing bezuclastinib as a best-in-class KIT mutant inhibitor for systemic mastocytosis and gastrointestinal stromal tumor (GIST) patients," said Andrew Robbins, President and CEO of Cogent Biosciences. "All three late-stage bezuclastinib clinical trials are actively enrolling patients, and we look forward to presenting initial clinical data from APEX in the first half of 2022. In addition, we are excited about the progress the Cogent Research Team has made to date and look forward to sharing further details on bezuclastinib, as well as our growing portfolio, at our upcoming R&D Investor Event."

Key Clinical, Research and Corporate Highlights

Cogent’s highly potent and selective KIT mutant inhibitor, bezuclastinib, is now under investigation in three late-stage clinical trials:

APEX: on track for initial clinical data readout in the first half of 2022
Cogent is currently enrolling APEX, a global, multicenter, Phase 2 clinical trial of bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM) and expects to report initial clinical data at a scientific conference during the first half of 2022, including levels of serum tryptase, a validated biomarker of mast cell activity. Learn more about the APEX trial at cogentclinicaltrials.com/APEX.

SUMMIT: initiated in patients with Nonadvanced Systemic Mastocytosis (NonAdvSM)
Cogent is currently enrolling SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial. The study is designed to explore the safety and efficacy of bezuclastinib in patients with moderate to severe Indolent Systemic Mastocytosis (ISM) or Smoldering Systemic Mastocytosis (SSM). Learn more about the SUMMIT trial at cogentclinicaltrials.com/SUMMIT.

PEAK: initiated in patients with Gastrointestinal Stromal Tumors (GIST)
During the fourth quarter of 2021, Cogent initiated and now is currently enrolling PEAK, a randomized, open-label, global, Phase 3 clinical trial. The PEAK study is designed to explore the efficacy of bezuclastinib in combination with sunitinib compared to sunitinib alone in patients with locally advanced, unresectable or metastatic GIST who have received prior treatment with imatinib. Learn more about the PEAK trial at cogentclinicaltrials.com/PEAK.

Preclinical data presented during the third quarter of 2021 highlights bezuclastinib as a potent KIT inhibitor with minimal CNS penetration and which avoids PDGFR inhibition:

Cogent presented preclinical data providing further evidence of bezuclastinib as a differentiated, potent, and selective KIT mutant inhibitor with minimal brain penetration while avoiding inhibition of PDGFR isoforms. These data were presented in a virtual poster at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper).

Cogent Research Team created to generate robust pipeline of potential best-in-class small molecules

Cogent Research Team: In 2021, we founded a highly-experienced Boulder-based discovery and research team focused on pioneering best-in-class, small molecule therapeutics to expand Cogent’s pipeline. John Robinson, PhD, leads the Cogent Research Team, which has grown to over 35 employees and will move into its newly-built, state-of-the-art research facility in Boulder this spring.

R&D Investor Event: Cogent will host an R&D Investor Event at which the Cogent Research Team will share additional nonclinical data demonstrating bezuclastinib’s potential as a best-in-class KIT mutant inhibitor, outline its strategy and focus to create best-in-class small molecules, and present early data from its growing pipeline of novel, small molecule targeted therapy programs including FGFR2. The R&D Investor Event will be a live webcast on Friday, April 8, 2022 beginning at 4:05p.m. ET. On the day of the webcast, the American Association for Cancer Research (AACR) (Free AACR Whitepaper) poster presentations will be made available through the AACR (Free AACR Whitepaper) conference website at 1:00 p.m. ET. Additional details about the R&D Investor Event will be shared in the coming weeks.

Successfully bolstered Cogent balance sheet utilizing our At-The-Market (ATM) Program: In Q4 2021, pursuant to Cogent’s ATM program, we completed the sale of common shares to certain institutional investors for net proceeds of approximately $38 million with offering prices ranging between $9.25 and $10.30 per share.

Appointed Zamaneh Mikhak, MD as Senior Vice President, Head of Clinical Development

Dr. Mikhak joins as an allergist/immunologist and physician scientist with over 20 years of experience in clinical practice and basic and translational research. Prior to joining Cogent, she held several leadership roles with increasing responsibilities, most recently leading clinical stage programs at both Boston Pharmaceuticals and Kiniksa Pharmaceuticals. Dr. Mikhak was an Assistant Professor at Harvard Medical School and an NIH funded Principal Investigator at Massachusetts General Hospital prior to joining industry. She earned her MD from the Perelman School of Medicine at the University of Pennsylvania and her Bachelor of Arts degree in Biology from Boston University.

Appointed Lei Sun, PhD as Vice President, Clinical Pharmacology & Translational Medicine

Dr. Sun joins with over 20 years of industry experience with demonstrated leadership in clinical pharmacology, translational medicine, and DMPK in multiple therapeutic areas. Prior to joining Cogent, she was Head of Clinical Pharmacology at Alkermes. Earlier in her career, Dr. Sun held several roles of increasing responsibility at Ziopharm Oncology, Alnylam Pharmaceuticals, and Wyeth/Pfizer. Dr. Sun received her PhD in Chemistry & Chemical Biology and MS in Chemical & Biochemical Engineering from Rutgers University and her BS in Material Sciences & Engineering from Tianjin University in China.

Appointed Lora Marden as Vice President, Patient Advocacy, Engagement and Innovation

Ms. Marden joins with over 15 years of rare disease biopharmaceutical and social services experience. Prior to joining Cogent, Ms. Marden was the Head of Global Patient Advocacy & Engagement at Kiniksa Pharmaceuticals. Previously, she held roles of increasing leadership responsibility in the areas of marketing, patient advocacy, medical affairs, commercial operations, and patient services at Sanofi-Genzyme, Alnylam Pharmaceuticals, and Sobi Inc., including contributing to the launch of multiple rare disease therapies. She currently sits as a Board Member for the MassBioEd Foundation and holds a Bachelor of Arts in Psychology from the University of Rochester.

Fourth Quarter and Year End 2021 Summarized Financial Results

R&D Expenses: Research and development expenses were $20.5 million for the fourth quarter of 2021 and $55.9 million for the year ended December 31, 2021, as compared to $6.1 million for the fourth quarter of 2020 and $25.7 million for the year ended December 31, 2020. These expenses included trial start-up costs associated with SUMMIT and PEAK and initial costs related to expanding the Cogent Research Team.

G&A Expenses: General and administrative expenses were $5.1 million for the fourth quarter of 2021 and $19.6 million for the year ended December 31, 2021, as compared to $5.3 million for the fourth quarter of 2020 and $17.4 million for the year ended December 31, 2020.

Net Loss: Net loss was $24.9 million for the fourth quarter of 2021 and $72.3 million for the year ended December 31, 2021, as compared to a net loss of $11.3 million for the fourth quarter of 2021 and $74.8 million for the year ended December 31, 2020.

Cash and Cash Equivalents: As of December 31, 2021, Cogent had cash and cash equivalents of $219.7 million. The company believes that its cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2024.

Sanofi announces €300 million collaboration with Blackstone Life Sciences to advance an innovative treatment for multiple myeloma

On March 15, 2022 Sanofi and Blackstone (NYSE: BX) reported a strategic, risk-sharing collaboration under which funds managed by Blackstone Life Sciences (BXLS) will contribute up to €300 million to accelerate the global pivotal studies and the clinical development program for the subcutaneous formulation and delivery of the anti-CD38 antibody Sarclisa, to treat patients with multiple myeloma (MM) (Press release, Sanofi, MAR 15, 2022, View Source [SID1234610075]). If successful, BXLS will be eligible to receive royalties on future subcutaneous sales. The pivotal study for the subcutaneous formulation is expected to begin in the second half of 2022.

For the Sarclisa subcutaneous formulation delivery, Sanofi has partnered with drug delivery technology innovator company Enable Injections, Inc. to advance the development of a subcutaneous delivery for Sarclisa with the goal of offering a unique patient-centric treatment experience.

To-date, Sarclisa has received regulatory approval for intravenous administration to treat certain patients with relapsed MM and is under investigation across the MM treatment continuum of care for other hematologic malignancies and solid tumors.

John Reed, MD, Ph.D.
Global Head of Research and Development for Sanofi
"The collaboration with Blackstone will accelerate our ability to offer patients a subcutaneous anti-CD38 antibody therapy that we believe will be innovative and more convenient. We are committed to building an industry-leading, sustainable pipeline with a steady stream of new therapies that have the potential to transform the practice of medicine".

Nicholas Galakatos, Ph.D.
Global Head of Blackstone Life Sciences
"We are excited to collaborate with Sanofi’s experienced development team to advance a subcutaneous dosage form for Sarclisa for patients. Our investment demonstrates Blackstone’s commitment and ability to provide innovative sources of financing to the world’s leading pharmaceutical companies as we offer capital at scale and complementary expertise to help advance important medicines in critical therapeutic areas."

Sanofi has considerable expertise in oncology and has increased research and development capabilities, focusing on difficult to treat cancers, including breast, blood, and lung.

Additional terms of the collaboration were not disclosed.

About Sarclisa

Sarclisa is a monoclonal antibody that targets a specific epitope on the CD38 receptor on MM cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.

Based on the Phase 3 ICARIA-MM study, Sarclisa is approved in a number of countries in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed refractory MM (RRMM) who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor. Based on the Phase 3 IKEMA study, Sarclisa is also approved in combination with carfilzomib and dexamethasone in the U.S. for the treatment of patients with RRMM who have received 1–3 prior lines of therapy and in the European Union for patients with MM who have received at least 1 prior therapy. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA).

Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. The safety and efficacy of these additional uses have not been reviewed by any regulatory authority worldwide.

For more information on Sarclisa clinical trials, please visit www.clinicaltrials.gov.

About Multiple Myeloma

Multiple myeloma (MM) is the second most common hematologic malignancy,1 with more than 130,000 new global annual diagnoses2. Despite available treatments, MM remains an incurable malignancy and is associated with significant patient burden. Since MM does not have a cure, most patients will relapse. Relapsed MM is the term for when the cancer returns after treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy.

Precision BioSciences Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Provides Business Update

On March 15, 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 fourth quarter and fiscal year ended December 31, 2021 (Press release, Precision Biosciences, MAR 15, 2022, View Source [SID1234610074]).

"Precision BioSciences made significant progress in 2021 toward validating our differentiated ARCUS gene editing platform to improve human health. Our team advanced two ex vivo CAR T product candidates targeting CD19 with the goal of developing a potential first-in-class and a potential best-in-class allogeneic CAR T treatment, if approved. We began operationalizing two key strategic partnerships, including our transformational in vivo gene editing alliance with Lilly covering up to six gene targets, and a partnership with iECURE targeting expedited clinical development of our wholly owned PBGENE-PCSK9 program. Under the iECURE agreement we expect ARCUS and its unique properties to be leveraged in four gene insertion programs for rare diseases," said Michael Amoroso, Chief Executive Officer at Precision BioSciences. "Finally, in late 2021, we completed the spin-out of our food and agriculture business to allow our team to focus solely on human therapeutics."

"Looking ahead to the remainder of 2022 and beyond, we intend to continue building on our operational effectiveness and take the next steps to further validate ARCUS clinically. In addition to planned updates for our ongoing allogeneic CAR T clinical studies with PBCAR0191, PBCAR19B, and PBCAR269A in 2022, we also plan to advance three wholly owned in vivo gene editing programs to investigational new drug applications (IND) or clinical trial applications (CTA) over the next three years," Mr. Amoroso continued.

Recent Developments and Upcoming Milestones:

Ex Vivo Allogeneic CAR T Portfolio:

Precision’s CAR T cells are the only allogeneic CAR T cells in human clinical trials made with a single-gene editing step, enabled by ARCUS, which is specifically designed to avoid potentially deleterious off target editing effects and preserve cell health and viability.

PBCAR0191: Precision presented updated interim data on its Phase 1/2a study of PBCAR0191 with enhanced lymphodepletion1 (eLD) at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which included 22 heavily pre-treated relapsed/refractory subjects with predominantly advanced or aggressive B-cell malignancies who received a median five lines of prior treatment, including 27% (6/22) who previously received a CD19-directed autologous CAR T product and progressed.

For patients that received treatment of PBCAR0191 following eLD as of November 16, 2021:

PBCAR0191 showed no ≥ Grade 3 cytokine release syndrome (CRS), one Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) with resolution to ≤ Grade 2 in 72 hours, no evidence of graft-versus-host disease, and one infectious death at Day 54 deemed possibly related to treatment.
PBCAR0191 yielded an overall response rate (ORR) of 73% and a complete response rate (CR) of 59% using a single dose of 3 × 106 cells/kg at ≥Day 28.
Four responders among the 17 evaluable non-Hodgkin’s lymphoma (NHL) subjects reached Day 180 durability assessment with a single dose.
Most notably, a potential signal for PBCAR0191 was observed among six subjects that previously received an autologous CAR T therapy and progressed:

These subjects experienced an ORR of 100% and a CR of 66% at ≥Day 28.
More than half of these subjects had a longer duration of response on PBCAR0191 than with the prior autologous CAR T treatment.
Precision BioSciences is prioritizing enrollment of these high unmet need NHL patients who have relapsed after receiving an autologous CAR T therapy as a potential path for PBCAR0191 to be a potential first-in-class allogeneic CAR T therapy.

PBCAR19B: PBCAR19B is a novel, immune-evading stealth cell candidate employing a single-gene edit to knock-down beta-2 microglobulin and express an HLA-E transgene. 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 completed dosing at Dose Level 1. Precision plans to commence dosing at the next dose level with clinical trial material from an optimized manufacturing process once released and expects to provide a program update in mid-2022.

CD19 Combination with Foralumab: Precision also plans to evaluate one of its anti-CD19 CAR T cell candidates in combination with foralumab, a fully humanized anti-CD3 antibody from Tiziana Life Sciences, and expects to update its IND in 2022 to enable combination use. Including an anti-CD3 antibody as part of the lymphodepletion regimen may further reduce CAR T cell rejection by targeting CD3+ host T cells and suppressing their anti-CAR T response, enabling the CAR T cells to expand, proliferate, and persist to maximize long term clinical benefits.

PBCAR269A: PBCAR269A is an investigational allogenic 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 and expects to provide an update in mid-2022.

In Vivo Gene Editing Portfolio:

With respect to its own wholly owned organic pipeline, Precision expects that three of its preclinical in vivo programs will advance to IND or CTA in the next three years:

PBGENE-PCSK9: In 2021, Precision initiated a collaboration with iECURE, a mutation-agnostic in vivo gene editing company co-founded by James M. Wilson, M.D., Ph.D., pursuant to which Precision’s wholly owned PBGENE-PCSK9 candidate is expected to be advanced through preclinical activities as well as a Phase 1 study in familial hypercholesterolemia. Long-term durability and safety of ARCUS in vivo gene editing to cut LDL cholesterol levels in nonhuman primates (NHPs) has been published in Nature Biotechnology (July 2018) and Molecular Therapy (June 2021). Nearly five years later, NHPs in this 2017 study continue to be monitored for ongoing, sustained reduction of LDL cholesterol levels while maintaining stable gene editing and data from these trials has not shown any obvious adverse events to date. A CTA filing is expected as early as the end of 2022. iECURE also expects to use an ARCUS nuclease to develop gene insertion programs in four rare genetic diseases.
PBGENE-PH1: Preclinical research continues to progress for Precision’s wholly owned in vivo gene editing program applying ARCUS to knock out the HAO1 gene as a potential one-time treatment for primary hyperoxaluria type 1 (PH1). Precision has initiated IND-enabling activities and expects to submit an IND or CTA in 2023 for PBGENE-PH1 delivered by lipid nanoparticle (LNP).
PBGENE-HBV: Precision’s gene editing program for chronic HBV applies ARCUS to knock out persistent closed circular DNA (cccDNA) and inactivate integrated hepatitis B genomes, potentially achieving durable HBV S-antigen (HBsAg) loss and viral clearance. Previously reported preclinical data has shown that ARCUS efficiently targeted and degraded HBV cccDNA in HBV-infected primary human hepatocytes and reduced expression of HBsAg by as much as 95%. Utilizing newly developed models of HBV infection, high levels of ARCUS gene editing were demonstrated in both mice and non-human primates after LNP administration of ARCUS mRNA. In the HBV mouse model, which sustains HBsAg expression, ARCUS gene editing resulted in >95% HBsAg reduction. Precision will pursue clinical development of its PBGENE-HBV candidate using LNP delivery and expects to submit an IND/CTA in 2024.
In 2021, Precision began an in vivo gene editing collaboration with Lilly and made progress applying ARCUS nucleases for three initial targets, including Duchenne muscular dystrophy in muscle, a central nervous system directed target, and a liver directed target.

Corporate:

In December 2021, Precision announced its entry into an agreement with a syndicate of investors led by ACCELR8 to separate its wholly owned Elo Life Systems subsidiary and create an independent food and agriculture business, which is intended to enable us to focus exclusively on human therapeutics.

Fiscal Year 2021 Financial Results:

Cash and Cash Equivalents: As of December 31, 2021, Precision had approximately $143.7 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 year ended December 31, 2021 were $115.5 million, as compared to $24.3 million for the same period in 2020. The increase of $91.2 million in revenue during the year ended December 31, 2021 was primarily the result of a $54.8 million increase in revenue recognized under the Servier Agreement as the performance obligation was deemed fully satisfied upon the execution of the Program Purchase Agreement with Servier, a $21.0 million increase in revenue recognized under the Lilly Agreement as work began in 2021, a $17.9 million increase in revenue recognized under the iECURE Agreement which was executed in 2021, and a $2.9 million increase in revenue recognized from an agricultural partnering collaboration.

Research and Development Expenses: Research and development expenses were $115.2 million for the year ended December 31, 2021, as compared to $98.1 million for the same period in 2020. The increase of $17.1 million in research and development expenses was primarily due to a $11.3 million increase in expenses related to the Servier Program Purchase Agreement, pursuant to which the Company reacquired all of its global development and commercialization rights related to ex vivo allogeneic CAR T targets previously named by Servier pursuant to the Servier Development and Commercial License Agreement.

General and Administrative Expenses: General and administrative expenses were $39.7 million for the year ended December 31, 2021, as compared to $36.1 million for the same period in 2020. The increase was primarily due to costs required to meet our growing infrastructure needs, including an increase of $3.9 million in general and administrative employee-related costs associated with increased wages, share-based compensation, and recruiting costs for key management personnel.

Net Loss: Net loss was $30.6 million, or $(0.52) per share (basic and diluted), for the year ended December 31, 2021, as compared to a net loss of $109.0 million, or $(2.09) per share (basic and diluted), for the same period in 2020.