On August 8, 2022 Genmab A/S (Nasdaq: GMAB) reported that it is improving its 2022 financial guidance published on May 11, 2022 (Press release, Genmab, AUG 8, 2022, View Source [SID1234617764]). The improved guidance is driven primarily by increased royalty revenue due to higher net sales of DARZALEX and the positive net foreign exchange impact of the strong U.S. Dollar.

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Genmab expects its 2022 revenue to be in the range of DKK 12,000 – 13,000 million, an increase to the previous guidance of DKK 11,000 – 12,000 million, driven primarily by the continued strong growth of DARZALEX net sales as well as the positive impact of the strong U.S. Dollar. Genmab’s projected revenue for 2022 primarily consists of DARZALEX royalties. Such royalties are based on Genmab’s revised estimate of DARZALEX 2022 net sales of USD 7.8 – 8.2 billion compared to Genmab’s previous estimate of USD 7.5 – 8.0 billion.

Genmab anticipates its 2022 operating expenses to be in the range of DKK 7,600 – 8,200 million, an increase to the previous guidance of DKK 7,200 – 7,800 million, driven by increased investment related to pipeline progression and epcoritamab launch readiness activities as well as the negative impact of the strong U.S. Dollar.

Genmab now expects its 2022 operating profit to be in the range of DKK 3,800 – 5,400 million, an increase to the previous guidance of DKK 3,200 – 4,800 million, driven primarily by the items described above.

Genmab’s financial results for the first half of 2022 will be published on August 10, 2022.

The above expectations are based on assumptions including those described on pages 5 and 6 of the Interim Report for the First Quarter of 2022 (Company Announcement No. 17/2022) as well as an updated USD/DKK exchange rate of 6.8, compared to the previous exchange rate of 6.4.

On August 8, 2022 As a result of recent research revealing that a significant number of colorectal cancer patients with actionable variants are missed under previous genetic testing guidelines, the National Comprehensive Cancer Network (NCCN) reported that new guidelines calling for testing to be available to all patients diagnosed with colorectal cancer (Press release, Invitae, AUG 8, 2022, View Source [SID1234617763]). Specifically, NCCN recommended that germline multigene panel testing should be offered to all individuals with CRC age <50 and be considered for all others, particularly for, but not restricted to, those with evidence of mismatch repair in their tumor or suggestive family history. These new recommendations expand the current testing criteria, which limited testing to certain age groups and types of cancer.

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

The new NCCN guidelines follow recent landmark studies published in JAMA Oncology and Clinical Gastroenterology and Hepatology by Invitae and Mayo Clinic supporting universal genetic testing for all cancer patients, regardless of cancer type, age, stage or family history. The data showed that nearly 1 in 6 colorectal cancer patients had inherited gene mutations that increased their risk of cancer. Additionally, more than 10% of patients in the study had changes to their cancer treatments based on genetic testing findings – many of whom would have been missed by previous limited testing guidelines. The study also found that patients diagnosed with colorectal cancer at a younger age were more likely to have heritable genetic changes linked to an increased risk of cancer.

The new NCCN guidelines have the potential to impact millions, as colorectal cancer is the third most diagnosed cancer and an estimated 5 million people worldwide currently live with colorectal cancer according to the American Cancer Society. The lifetime risk of developing colorectal cancer according to ACS is about 1 in 23 for men and 1 in 25 for women, and there’s recently been an increase in incidence among people younger than 50 years old. Understanding risk and implementing screening strategies is essential to early detection and better outcomes for patients.

"As the medical community’s understanding of genetic links to cancer evolves, genetic testing guidelines must evolve with it," said Robert Nussbaum, M.D., chief medical officer of Invitae, who co-authored a letter in January 2022 to the NCCN formally requesting universal germline testing for patients with CRC be added to their guidelines. "In addition to excluding older people from receiving access to medically actionable information about their disease, previous guidelines were based on studies with an overrepresentation of individuals of European origin, potentially biasing and exacerbating existing disparities to those of non-European background."

"The number of genes with targeted therapeutic or clinical management implications for colorectal cancer has significantly increased in recent years," Dr. Nussbaum continued. "At the same time, genetic testing has become more affordable. These new guidelines will help identify more patients and their family members who might benefit from genetic assessment."

"The INTERCEPT study supports the use of universal germline genetic testing for patients with colorectal cancer, and has shown the clinical impact of this strategy in targeted therapy implementation, personalized clinical management and cascade family testing for prevention. The NCCN update will improve access for patients with colorectal cancer to the gene-directed precision care they need," Jewel Samadder, M.D., enterprise co-leader precision/individualized cancer medicine, Mayo Clinic Comprehensive Cancer Center.

In addition to recommending testing be either offered or considered for all diagnosed colorectal cancer patients, the NCCN guidelines recommend subsequent cascade testing of family members of colorectal cancer patients who have pathogenic variants identified in cancer risk genes. "This is one of the biggest challenges related to germline multigene panel testing for all colorectal cancer patients," explained Ed Esplin, M.D., Ph.D., FACMG, FACP, clinical geneticist at Invitae and a co-author of the INTERCEPT study. "Alerting other family members to be tested to determine increased risk and implementing more intensive surveillance could lead to earlier diagnosis, significantly higher chance of curative treatment and ultimately, prevention of colorectal cancer entirely for those at increased risk."

On August 8, 2022 Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on developing innovative products to treat metabolic and central nervous system ("CNS") disorders, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Lipocine, AUG 8, 2022, View Source [SID1234617762]).

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Second Quarter Highlights

In June, Lipocine’s commercial partner Halozyme launched TLANDO (testosterone undecanoate), an oral treatment indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism).
In July 2022, Lipocine held an End of Phase 2 meeting with the FDA for LPCN 1144 in NASH. The FDA recommends Lipocine conduct a phase 2 dose ranging study to identify the optimal dose prior to conducting a pivotal study. The FDA agreed to the proposed unique testosterone ester, testosterone dodecanoate, for future clinical studies.
LPCN 1111: Technology transfer for our once-a-day testosterone product candidate was completed. Scale up and manufacturing of registration batches is ongoing.
Lipocine continues to enroll subjects in a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhosis, with enrollment in the study expected to be complete in the second half of 2022.
A type C meeting was held with the FDA to discuss the clinical development path of LPCN 1154, our candidate for postpartum depression ("PPD"). Based on feedback from the meeting, the company plans to initiate a multi-dose proof-of-concept study of LPCN 1154 in the second half of 2022.
The FDA accepted the company’s Investigational New Drug Application ("IND") for its neuroactive steroid ("NAS") candidate, LPCN 2101, as a potential treatment for adults with epilepsy. Lipocine plans to initiate a Phase 2 photosensitive epilepsy ("PSE") study to evaluate the safety, tolerability, and efficacy of oral LPCN 2101 in women with epilepsy of childbearing age.
We continue to explore partnering LPCN 1111, LPCN 1144, LPCN 1107 and TLANDO ex-US to third parties.

Second Quarter Ended June 30, 2022 Financial Results

Lipocine reported a net loss of $2.6 million, or ($0.04) per diluted share for the quarter ended June 30, 2022, compared with a net loss of $6.8 million, or ($0.08) per diluted share, in the quarter ended June 30, 2021.

Revenues in the quarter ended June 30, 2022 were $0.5 million related to a non-refundable cash fee received from Antares for consideration of a 90-day extension to exercise its option to license LPCN 1111. Antares’ option to license TLANDO XR expired on June 30, 2022 and was not exercised. There was no revenue in the comparable quarter of 2021.

Research and development expenses were $2.9 million for the quarter ended June 30, 2022, compared with $1.5 million for the quarter ended June 30, 2021. The increase in research and development expenses for the quarter ended June 30, 2022, was a result of an increase in contract research organization expense related to the Phase 2 POC study in male cirrhotic subjects with LPCN 1148, an increase in costs related to LPCN 1154 clinical studies, increases in personnel expenses, and an increase in costs related to LPCN 1111 scale up and LPCN 1107 expenses. These increases were offset by a decrease in contract research organization expenses and outside consulting costs related to the completion of the LiFT Phase 2 clinical study in NASH subjects in 2021, a decrease in costs associated with TLANDO, as well as a decrease in other R&D expenses.

General and administrative expenses were $1.1 million for the quarter ended June 30, 2022, compared with $1.5 million for the quarter ended June 30, 2021. The decrease in general and administrative expenses was primarily due to decreases in legal expenses and personnel costs. These decreases were offset by an increase in professional fees, an increase related to proxy solicitation and proxy distribution services, an increase in corporate insurance expenses, and an increase in other general and administrative expenses.

As of June 30, 2022, the company had $37.4 million of unrestricted cash, cash equivalents and marketable investment securities, compared to $46.6 million at December 31, 2021.

Six Months Ended June 30, 2022 Financial Results

Lipocine reported a net loss of $6.1 million, or ($0.07) per diluted share, for the six months ended June 30, 2022, compared with a net loss of $10.2 million, or ($0.12) per diluted share, in the six months ended June 30, 2021.

Revenues in the six months ended June 30, 2022 were $0.5 million related to a non-refundable cash fee received from Antares for consideration of a 90-day extension to exercise its option to license LPCN 1111, as described above. There was no revenue in the comparable period of 2021.

Research and development expenses for the six months ended June 30, 2022, were $4.8 million compared to $3.0 million for the comparable period in 2021. The increase in research and development expenses was due to an increase in contract research organization expense related to the Phase 2 POC study in male cirrhotic subjects with LPCN 1148, an increase in costs related to LPCN 1154 clinical studies, an increase related to LPCN 1111 scale up activities, a food effect study in LPCN 1107, and an increase in personnel expenses and other research and development costs. These increases were offset by a decrease in contract research organization expense and outside consulting costs related to the completion of our LPCN 1144 LiFT Phase 2 clinical study in NASH subjects in 2021, and a decrease in costs associated with TLANDO.

General and administrative expenses for the six months ended June 30, 2022 were $2.4 million compared to $3.1 million for the comparable period in 2021. The decrease in general and administrative expenses was primarily due to decreases in legal expenses, personnel costs, and other general and administrative expenses. These decreases were offset by an increase in professional fees, an increase related to proxy solicitation and proxy distribution services, an increase in various other consulting fees, and an increase in corporate insurance expenses.

On August 8, 2022 Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious disease using its patented iSPERSE technology, reported second quarter financial results for 2022 and provided a corporate update related to its development programs (Press release, Pulmatrix, AUG 8, 2022, View Source [SID1234617761]).

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Ted Raad, Chief Executive Officer of Pulmatrix commented, "Our focus this quarter has been on advancing both PUR3100 and Pulmazole towards important data catalysts. We initiated patient dosing for PUR3100, our orally inhaled dihydroergotamine (DHE), in a Phase 1 study with data anticipated in Q4 2022. In addition to safety and tolerability, the study will evaluate the pharmacokinetics of PUR3100 and intravenous dihydroergotamine (DHE). This will allow us to better understand the potential efficacy and tolerability profile of PUR3100." Mr. Raad continued, "We also commenced study start-up activities for the Pulmazole Phase 2b study and remain on track to initiate patient dosing in Q1 2023. Pulmazole has the potential to be the first approved therapy for treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Asthma."

Second Quarter 2022 and Recent Program Highlights

Pulmazole (PUR1900)

Pulmatrix initiated study start-up activities for the Phase 2b efficacy study of Pulmazole, which will include a 16-week dosing regimen and potential registration endpoints that would potentially support a registrational trial.
PUR3100

On July 12, 2022, Pulmatrix announced the dosing of the first five subjects in a Phase 1 trial. To date, the trial has enrolled 23 of 24 patients and top-line data is anticipated in Q4 2022.
PUR1800

Pulmatrix is analyzing data from the completed Phase 1b clinical study of PUR1800 for future publication and conducting further modeling to inform the Phase 2 study design.
Second Quarter 2022 Financial Results

Revenue was $1.3 million for the second quarter ended June 30, 2022, compared to $2.2 million for the same period in 2021, a decrease of $0.9 million. The decrease in revenue was due to no revenues recorded for this period for the PUR1800 program offset by a $1.0 million increase in revenues recorded this period over same period in 2021 on the Cipla Agreement for Pulmazole (PUR1900).

For the three months ended June 30, 2022, research and development expenses were $4.3 million compared to $4.5 million for the same period in 2021, a decrease of $0.2 million. The decrease was primarily due to decreased spending of $0.9 million in preclinical and clinical costs related to the PUR 1800 program and $0.5 million in preclinical and manufacturing costs related to the PUR 3100 program, partially offset by increased spending of $0.6 million in clinical and manufacturing costs related to the Pulmazole program, $0.5 million in employment costs and $0.1 million in facility costs.

General and administrative expenses were unchanged at $1.6 million for the three months ended June 30, 2022 compared to the same period in 2021.

Total cash and cash equivalents balance as of June 30, 2022 was $42.9 million. Pulmatrix expects its existing cash and cash equivalents as of June 30, 2022 will enable it to fund operating expenses and capital expenditure into Q2 2024.

On February 28, Pulmatrix completed a reverse stock-split at a ratio of 1-for-20 (the "Reverse Split") which reduced the number of outstanding shares of the Company’s common stock from approximately 65.9 million shares to 3.3 million shares.

On August 8, 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 second quarter ended June 30, 2022 and provided a business update (Press release, Precision Biosciences, AUG 8, 2022, View Source [SID1234617742]).

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"This past quarter, we have executed on many important aspects of our business. From manufacturing optimization to clinical trial progress to business development and operational advancements, we are making strides towards delivering on the potential of ARCUS genome editing for drug development and adding significant cash to our balance sheet. Most exciting this past quarter, we entered into a collaboration agreement with Novartis to develop a potential one-time treatment option for hemoglobinopathies including sickle cell disease and beta thalassemia using ARCUS for gene insertion. We are very excited about expanding ARCUS into potential indications that require more complex edits, such as gene insertion," said Michael Amoroso, Chief Executive Officer at Precision BioSciences.

"For our CAR T programs, Q2 2022 was also an exciting time for us to share encouraging new interim clinical data for our lead PBCAR0191 program. We believe the latest update validated the signal of high response rates to PBCAR0191 observed among CAR T relapsed patients we reported at the 2021 American Society for Hematology (ASH) (Free ASH Whitepaper) meeting, further supporting our potential path forward in this patient population. We have recently released optimized batches of our PBCAR19B clinical trial material and look forward to commencing dosing in the next cohort of patients this quarter. In addition, we dosed PBCAR269A in combination with nirogacestat at Dose Level (DL) 3. We expect to provide additional updates across our CAR T portfolio by the end of the year," concluded Michael Amoroso.

Recent Developments and Upcoming Milestones:

Ex Vivo Allogeneic CAR T Portfolio:

PBCAR0191: PBCAR0191, azercabtagene zapreleucel (azer-cel), is Precision’s lead investigational anti-CD19 allogeneic CAR T candidate in a Phase 1/2a clinical trial of adult subjects with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL). In June 2022, Precision provided new interim data as of May 31, 2022, including high and durable clinical response rates among subjects who received a median of five prior lines of therapy. Evaluable subjects in the latest cohort of the study had the following results:

100% Overall Response Rate (ORR) and 73% Complete Response (CR) rate

50% durable response rate greater than six months

No Grade 3 or greater cytokine release syndrome (CRS) was observed in either dosing cohort. One Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) was recorded in each cohort that rapidly resolved to Grade 1 within 24 to 48 hours. Two Grade 5 events associated with late occurring encephalopathy suspected to be related to fludarabine-associated neurotoxicity occurred. There was no evidence of graft versus host disease.

In the second half of 2022, Precision plans to continue dosing subjects with optimized PBCAR0191 CAR T cells in this relapsed patient population while further reducing its lymphodepletion dose to standard levels.

PBCAR19B: PBCAR19B is Precision’s second generation, anti-CD19 targeting allogeneic CAR T candidate designed to evade immune rejection by host T cell and natural killer (NK) cells with a single-gene edit to knock-down beta-2 microglobulin and insert an HLA-E transgene. Manufacturing optimization for PBCAR19B was implemented in the first quarter of 2022. New clinical trial material has been released, and the company plans to commence dosing in the next cohort, DL 2 (flat dose of 540 million cells), in the third quarter of 2022.

PBCAR269A: PBCAR269A is Precision’s 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 (GSI) developed by SpringWorks Therapeutics. Precision has completed DL2 (2.0 × 106 cells/kg) of PBCAR269A plus GSI and is initiating the next cohort at DL3 (flat dose of 480 ×106 cells) to further evaluate efficacy. To date, peak expansion rates observed at DL2 plus the GSI have been equivalent to DL4 (960 × 106 cells flat dose) monotherapy with no dose limiting toxicities observed.

Precision expects to provide the next update on its clinical ex vivo allogeneic CAR T programs toward year-end 2022.

In Vivo Gene Editing Portfolio:

Novartis In Vivo Gene Editing Collaboration: In June 2022, Precision announced it had entered into an exclusive worldwide in vivo gene editing research and development collaboration and license agreement with Novartis. As part of the agreement, Precision will develop a single, custom ARCUS nuclease designed to insert, in vivo, a therapeutic transgene at a "safe harbor" location in the genome as a potential one-time transformative treatment option for diseases including certain hemoglobinopathies such as sickle cell disease and beta thalassemia. Precision will conduct in vitro characterization, with Novartis then assuming responsibility for all subsequent research, development, manufacturing and commercialization activities.

In addition to a $25 million equity investment from Novartis in Precision’s common stock at $2.01 per share received in June 2022, Precision received an upfront cash payment of $50 million on July 12, 2022 and is eligible to receive up to an aggregate amount of approximately $1.4 billion in additional payments for future milestones. Precision is also eligible to receive certain research funding and tiered royalties ranging from the mid-single digits to low-double digits on product sales, should Novartis successfully commercialize a therapy from the collaboration.

Lilly In Vivo Gene Editing Programs: 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.

PBGENE-PH1: Precision has initiated IND-enabling activities for its PBGENE-PH1 candidate designed to knock out the 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 (NHP) study for PBGENE-PH1 delivered by LNP and is targeting an IND or CTA submission in 2023, subject to evaluation of data from the ongoing preclinical NHP study. Preclinical data for Precision’s PBGENE-PH1 was presented at the 2022 American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting and demonstrated a robust knockdown of the HAO1 protein in non-human primates following a single administration of an ARCUS nuclease via AAV.

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 reducing viral persistence. Preclinical data from this program was presented during the Gene Editing in Cancer and Complex Diseases oral session at the ASGCT (Free ASGCT Whitepaper) Annual Meeting and within the same month published online in Molecular Therapy in May 2022. As reported, ARCUS efficiently targeted and degraded hepatitis B virus (HBV) cccDNA by 85% and reduced expression of HBsAg by 77% in HBV-infected primary human hepatocytes (PHH). Importantly, the optimized specificity of the ARCUS nuclease completely prevented detectable chromosomal translocations in the PHH model. PBGENE-HBV candidate is in pre-clinical development and Precision is targeting an IND/CTA submission in 2024 following completion of pre-clinical and IND enabling studies.

PBGENE-PCSK9: In 2021, Precision initiated a collaboration with iECURE, pursuant to which iECURE is expected to advance Precision’s PBGENE-PCSK9 candidate through preclinical activities as well as a Phase 1 study in familial hypercholesterolemia. As of this date, IND enabling activities for PBGENE-PCSK9 have not been completed. We are in discussions with iECURE and will provide an update on the program when more information is available.

Quarter Ended June 30, 2022 Financial Results:

Cash and Cash Equivalents: As of June 30, 2022, Precision had approximately $184.1 million in cash and cash equivalents, including receipts of $25.0 million from Novartis’ equity investment in the Company and proceeds from the June 2022 underwritten offering of the Company’s common stock, described below. The Company expects that existing cash and cash equivalents, including the cash payment of $50.0 million received from Novartis on July 12, 2022, expected operational receipts, and available credit will be sufficient to fund its operating expenses and capital expenditure requirements to the end of 2024.

In June 2022, Precision announced the closing of an underwritten offering of 35,971,224 shares of its common stock at an offering price of $1.39 per share, for total net proceeds of approximately $46.7 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company.

Revenues: Total revenues for the quarter ended June 30, 2022 were $3.8 million, as compared to $68.8 million for the same period in 2021. The decrease of $65.0 million in revenue during the quarter ended June 30, 2022 was primarily the result of the absence of $62.5 million in revenue recognized under the Servier Agreement in April 2021 subsequent to full satisfaction of the performance obligation, a $1.5 million decrease in revenue recognized under the Lilly Agreement, and a $0.9 million decrease in revenue recognized from an agriculture partnering collaboration.

Research and Development Expenses: Research and development expenses were $22.9 million for the quarter ended June 30, 2022, as compared to $37.2 million for the same period in 2021. The decrease of $14.3 million was primarily due to a decrease of $11.3 million related to the Servier Program Purchase Agreement, a decrease of $2.1 million in external development costs associated with our allogeneic CAR T product candidates, a decrease of $1.3 million in employee-related costs due to reduced headcount, and a decrease of $1.7 million in clinical manufacturing organization and research costs related to our preclinical studies. These decreases were partially offset by a $1.5 million increase in sublicensing royalty payable to Duke on the Novartis upfront payment.

General and Administrative Expenses: General and administrative expenses were $10.5 million for the quarter ended June 30, 2022, as compared to $9.9 million for the same period in 2021. The increase of $0.6 million was primarily due to costs required to meet our growing infrastructure needs, including consulting fees and employee-related costs associated with increased share-based compensation expense.

Net Loss: Net loss was $31.0 million, or $(0.46) per share (basic and diluted), for the quarter ended June 30, 2022, as compared to net income of $21.7 million, or $0.38 per share (basic) and $0.36 per share (diluted), for the same period in 2021.

Corporate:

Executive Leadership: In May 2022, Juli Blanche was appointed Chief People Officer and a member of the senior leadership team. Ms. Blanche joined Precision from Bristol-Myers Squibb where she was Senior Vice President and HR Business Partner, Global Commercialization. She brings over 25 years of strategic business partnership and enterprise leadership experience in the pharmaceutical and financial services industries.

Board of Directors: In May 2022, Melinda Brown was appointed as a Director on Precision’s Board of Directors and Chair of the Board’s Audit Committee. Ms. Brown is a financial expert with proven experience leading accounting, finance and enterprise risk management teams in large, public companies, including Tapestry, Inc. and PepsiCo, Inc.

Together, Ms. Blanche and Ms. Brown provide substantial executive leadership that will be paramount for Precision as the company embarks upon the next phase of its life cycle.