On May 9, 2022 OPKO Health, Inc. (NASDAQ: OPK) reported business highlights and financial results for the three months ended March 31, 2022 (Press release, Opko Health, MAY 9, 2022, View Source [SID1234613922]).

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Business Highlights

Business highlights for the first quarter of 2022 and subsequent weeks include the following:

Acquired ModeX Therapeutics, Inc. (ModeX), gains proprietary immunotherapy technology, new executives and Directors. ModeX is a privately held biotechnology company focused on developing innovative multi-specific immune therapies for cancer and infectious diseases. In connection with the acquisition, Dr. Elias Zerhouni joins OPKO as President and Vice Chairman of the Board of Directors, Dr. Gary Nabel joins as Chief Innovation Officer and a member of OPKO’s Board of Directors, and Alexis Borisy joins OPKO’s Board. OPKO acquired ModeX for $300 million in OPKO common stock.

Completed sale of GeneDx LLC (formerly GeneDx, Inc.) to Sema4 Holdings Corp. (Sema4). Sema4 acquired GeneDx for an upfront payment of $150 million in cash, subject to adjustments, plus 80 million shares of Sema4 Class A common stock, with up to an additional $150 million in revenue-based milestones over the next two years (payable in cash or Sema4 shares at Sema4’s discretion). Based on the closing price of Sema4’s Class A common stock on April 29, 2022, the date the transaction closed, the total upfront consideration is approximately $322 million and the total aggregate consideration including potential milestones is approximately $472 million.

Pfizer launched NGENLA (Somatrogon) injection in Germany, Japan and additional markets. NGENLA was granted marketing authorization by the Ministry of Health, Labour and Welfare in Japan and by the European Commission in January and February of this year, respectively. With the achievement of these milestones, OPKO earned an aggregate of $85 million in milestone payments. NGENLA is a once-weekly injection to treat pediatric patients with growth disturbance due to insufficient secretion of growth hormone. NGENLA provides pediatric patients, their caregivers and healthcare providers with a new treatment option for growth hormone deficiency that reduces the frequency of required injections from once-daily to once-weekly. Pfizer is OPKO’s global commercial partner for Somatrogon.

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) launched RAYALDEE in Germany, and subsequently in Switzerland. VFMCRP initiated the commercial launch of RAYALDEE (extended-release calcifediol) in Germany, the first launch of RAYALDEE outside the U.S. VFMCRP is OPKO’s commercial partner for RAYALDEE in Europe and selected markets outside the U.S. VFMCRP has received marketing authorizations for RAYALDEE in 11 European countries and expects to launch the product in additional markets.
First Quarter Financial Results

Diagnostics: Revenue from services in the first quarter of 2022 was $286.6 million compared with $507.0 million in the prior-year period, with the decrease primarily due to lower COVID-19 testing volume and related reimbursement, partially offset by an improvement in genomic test reimbursement and an increase in clinical and genomic test volumes. BioReference processed approximately 2.0 million COVID-19 PCR tests in the first quarter of 2022 versus 4.1 million in the first quarter of 2021. Total costs and expenses were $330.1 million in the first quarter of 2022 compared with $439.9 million in the first quarter of 2021, resulting in an operating loss of $43.5 million compared with operating income of $67.0 million in the 2021 period. Operating income decreased primarily due to a decline in the volume of COVID-19 tests.

Pharmaceuticals: Revenue from products in the first quarter of 2022 increased to $36.6 million from $33.9 million in the first quarter of 2021, with the increase primarily attributable to accelerating growth of OPKO’s international pharmaceutical businesses. Revenue from sales of RAYALDEE in the first quarter of 2022 was $5.1 million compared with $5.8 million in the prior-year period. Revenue from the transfer of intellectual property was $6.0 million in the first quarter of 2022 compared with $4.3 million in the 2021 period. During the first quarter of 2022, OPKO recognized a $3.0 million sales milestone from VFMCRP triggered by the first commercial sales in Europe. Total costs and expenses were $60.7 million in the first quarter of 2022 compared with $57.4 million in the prior-year period. The increase was driven by the amortization of NGENLA, which received approval in Europe and Japan during the first quarter of 2022, offset by a reduction in inventory reserve, legal expenses and selling expenses related to RAYALDEE. In addition, research and development expenses decreased reflecting reduced spending on the NGENLA development program. The operating loss was $18.1 million in the first quarter of 2022 compared with an operating loss of $19.2 million in the first quarter of 2021.

Consolidated: Consolidated total revenues for the first quarter of 2022 were $329.2 million compared with $545.2 million for the comparable period of 2021. Operating loss for the first quarter of 2022 was $72.4 million compared with operating income of $38.5 million for the 2021 quarter. Net loss for the first quarter of 2022 was $55.4 million, or $0.08 per share, compared with net income of $31.1 million, or $0.05 per diluted share, for the 2021 quarter.

Cash and equivalents: Cash and cash equivalents were $102.3 million as of March 31, 2022. In addition, OPKO has $64.8 million available under its line of credit with JP Morgan. Subsequent to the close of the quarter, OPKO received $150 million gross proceeds from the sale of GeneDx to Sema4. Also, OPKO expects to receive $85 million in milestone payments from Pfizer during the second quarter of 2022.
CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update, discuss first quarter financial results and the ModeX acquisition, and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call using this link. Callers who pre-register will be given a unique PIN to gain immediate access to the call and bypass the live operator. Those unable to pre-register may participate by dialing (866) 777-2509 (U.S.) or (412) 317-5413 (International). A webcast of the call may also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until May 16, 2022 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 6587528. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

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.

On May 9, 2022 Bavarian Nordic A/S (OMX: BAVA) reported its interim financial results and business progress for the first three months of 2022 (Press release, Bavarian Nordic, MAY 9, 2022, View Source [SID1234613954]).

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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "We have reported strong progress in our pipeline during the first quarter with additional Phase 2 results for our COVID-19 vaccine candidate, confirming its potential as a universal booster vaccine and we look forward to initiating the Phase 3 trial later this year. Furthermore, our RSV program was granted a Breakthrough Therapy Designation by the FDA, underlining the importance of the development of a vaccine to fulfil this high unmet medical need and to that end we initiated a Phase 3 program that will read out next year. In line with our RSV commercialization strategy, we were also pleased to enter a license and supply agreement covering selected Asian markets for RSV. Our rabies business demonstrated a stronger than expected performance in both US and Germany that off sets a slower than expected start of the TBE market during Q1. Based on current financial performance and current assessment of uncertainties and risks we maintain our full year financial guidance on revenue, EBITDA and cash."

Financial highlights from the first quarter

Revenue was DKK 320 million comprised of DKK 230 million from product sales, DKK 83 million in milestone payments from our RSV partner Nuance Pharma and DKK 7 million from contract work.
EBITDA was a loss of DKK 94 million.
Strong cash position of DKK 2,947 million at end of the period
Financial guidance for the full year is maintained at revenues between DKK 1,100 and 1,400 million, EBITDA with a loss between DKK -1,300 and -1,000 million and cash and cash equivalents at year-end unchanged between DKK 1,000 and 1,200 million.

* Repo pledged securities deducted.

Other highlights

In January, Bavarian Nordic announced the appointment of Russell Thirsk as new EVP and Chief Operating Officer to replace Henrik Birk, who has chosen to seek challenges outside Bavarian Nordic. Mr. Thirsk joined Bavarian Nordic in April from GSK, where he served as Head of Operations at GSK Vaccines in Belgium.
In February, the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation for the Company’s vaccine candidate, MVA-BN RSV, for the prevention of respiratory syncytial virus (RSV) in older adults. A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition.
In February, Bavarian Nordic announced additional results from the Phase 2 trial of its COVID-19 booster vaccine candidate, ABNCoV2. The results confirmed the ability of ABNCoV2 to boost neutralizing antibodies to levels reported to be highly efficacious (>90%) against SARS-CoV-21 both when used for primary vaccination and when used as a booster in subjects previously vaccinated with mRNA or Adeno-based vaccines.
In March, Bavarian Nordic entered into a license and supply agreement with Nuance Pharma on the development and commercialization of MVA-BN RSV for adults in China and selected Asian markets. Under the terms of the agreement, Bavarian Nordic could receive up to USD 225 million in upfront and milestone payments in addition to tiered, double-digit royalties. Nuance Pharma obtains rights to commercialize MVA-BN RSV in Chinese Mainland, Hong Kong, Macau, Taiwan, South Korea and Southeast Asia and will be responsible for all material costs, including development and regulatory.
Events after the reporting date

In April, Bavarian Nordic initiated a global Phase 3 clinical trial of MVA-BN RSV against RSV in older adults. The Phase 3 trial is planned to enroll approximately 20,000 adults, aged 60 years or older across approximately 115 sites in the U.S. and Germany. The trial is designed to run through the RSV season 2022/2023 with topline results expected mid 2023, if the pre-defined number of lower-respiratory tract disease events has occurred.
In May, Bavarian Nordic reported additional Phase 2 results for ABNCoV2, demonstrating that vaccination with ABNCoV2 induced a significant boost to the neutralizing antibodies against the Omicron variant in the majority of subjects (87%), who were previously vaccinated with approved mRNA or adenoviral vaccines. Neutralizing antibodies reached levels reported to be associated with a high level of protection (>90%).
Conference call and webcast

The management of Bavarian Nordic will host a conference call today at 2 pm CET (8 am ET) to present the interim results followed by a Q&A session. A listen-only version of the call can be accessed via View Source To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 72 04 17, UK: +44 (0) 844 481 9752, USA: +1 646-741-3167. Participant code is 7179801.

On May 9, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported the publication of clinical data from its dose escalation cohorts in its ongoing Phase 1 study of CART-ddBCMA for the treatment of patients with relapsed or refractory multiple myeloma (r/r MM) (Press release, Arcellx, MAY 9, 2022, View Source [SID1234613971]). The data were published in Blood Advances, the open-access journal of the American Society of Hematology (ASH) (Free ASH Whitepaper).

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The publication entitled, "Phase 1 Study of CART-ddBCMA for the treatment of subjects with relapsed and refractory multiple myeloma," reported the following:

Twelve patients in the dose escalation cohorts received a single dose of either 100×106 CART-ddBCMA (DL1, n=6) or 300×106 CART-ddBCMA (DL2, n=6) following a standard lymphodepletion regimen.
No cases of Grade 3 or higher CRS or ICANS occurred at DL1, the recommended Phase 2 dose.
No Parkinsonian-like movement disorders or atypical neurological toxicities were observed.
The maximally tolerated dose was not reached.
All patients dosed responded to CART-ddBCMA (ORR 100%) and 9/12 (75%) patients achieved CR/sCR.
Responses deepened over time and at the data cut (November 4, 2021; median follow-up 56 weeks), 7/9 (78%) of evaluable patients achieved minimal residual disease negativity at 10-5 or greater.
These findings demonstrate the potential safety of CART-ddBCMA cells and durable responses to CART-ddBCMA in r/r MM patients.
The full online publication can be accessed here.

"We are honored to have the clinical results of the first 12 patients treated in the dose escalation cohorts with CART-ddBCMA published in a prominent hematologic journal," said Rami Elghandour, Arcellx’s chairman and chief executive officer. "Given these initial results, we expanded our Phase 1 study at our intended Phase 2 pivotal study dose of 100 million cells, and believe these data are indicative of the potential for CART-ddBCMA to be a best-in-class treatment option for patients with multiple myeloma. We look forward to presenting new clinical data at ASCO (Free ASCO Whitepaper) on June 5 and initiating our Phase 2 pivotal study for CART-ddBCMA in the second half of this year."

About Multiple Myeloma
Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. Multiple myeloma is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.

About CART-ddBCMA
CART-ddBCMA is Arcellx’s BCMA-specific CAR-modified T-cell therapy utilizing the company’s novel BCMA-targeting binding domain for the treatment of patients with relapsed or refractory multiple myeloma. CART-ddBCMA is currently in a Phase 1 study. Arcellx’s proprietary binding domains are novel synthetic proteins designed to bind specific therapeutic targets. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

On May 9, 2022 Vaxart, Inc. (NASDAQ: VXRT) reported its business update for the first quarter of 2022, reporting continued progress on its oral vaccine candidates (Press release, Aviragen Therapeutics, MAY 9, 2022, View Source [SID1234614017]).

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"We continue to make progress on our pipeline of potentially game changing oral tablet vaccine programs, with norovirus studies that will report results in the second quarter as well as our Phase II study for our COVID-19 program that will report results from the first part of the planned two-part study in the third quarter," said Andrei Floroiu, Vaxart’s Chief Executive Officer. "Vaxart’s oral vaccine technology may address many public health challenges, including rapidly emerging COVID-19 variants because the cross-reactive nature of mucosal IgA response increases the likelihood of variant coverage."

Recent Business Highlights

Preclinical and Clinical

COVID-19 Vaccine Developments

In February 2022, Vaxart’s COVID-19 non-human primate study was published by bioRxiv. The study demonstrates that Vaxart’s S-only COVID-19 vaccine candidate, now being studied by Vaxart in Phase II trials, generated antibodies to the original COVID-19 virus strain and to the Beta, Delta, Alpha and Gamma variants of SARS-CoV-2 in the serum and nasal mucosa of non-human primates (NHPs).
Vaxart’s S-only candidate is believed to be the first vaccine candidate to demonstrate neutralizing antibody responses in mucosal sites, which is where primary infection occurs.
The candidate also induced a 1000-fold increase in nasal IgA responses to the variants, which may reduce community transmission.
In April 2022, an article was published in Vaccines that highlights the potential of Vaxart’s oral tablet vaccine platform to transform vaccine strategies for respiratory viral pathogens.
The article discusses one of the chief advantages of oral vaccines, which is to induce an immune response in the mucosa, the first line of defense against invading respiratory pathogens.
The article also outlines how Vaxart’s oral tablet vaccine candidates are very well suited to transform global vaccination strategies by potentially removing cold-chain requirements and the necessity of administration by healthcare professionals, enabling rapid deployment of new vaccines to address novel pathogens.
Vaxart now expects data from the dose selection portion of its two part dose-ranging and preliminary efficacy Phase II clinical trials of its oral tablet COVID-19 vaccine candidate to be available in the third quarter of 2022. This is an open-label dose and age escalation lead-in segment in naïve and previously vaccinated subjects.
Norovirus Vaccine Developments

Vaxart has dosed all subjects in its Phase IB placebo-controlled, dose-ranging, repeat dose trial of its oral norovirus vaccine candidate in elderly subjects aged 55 to 80 years. This study is designed to evaluate the safety and immunogenicity of Vaxart’s GI.1 vaccine candidate and results will be available in the second quarter of 2022.
Vaxart launched a Phase II GI.1 norovirus challenge study in January 2022 to evaluate the safety and clinical efficacy of its oral vaccine candidate. This double blind, placebo-controlled study uses a safe, well-characterized challenge with norovirus GI.1 of volunteers vaccinated with our monovalent norovirus vaccine candidate. The study will yield data on efficacy, safety, and immune correlates of protection, with data expected to be reported in the first quarter of 2023.
2022 Planned Clinical Milestones

Data from the first part of Vaxart’s two-part Phase II trial of its COVID-19 vaccine candidate is expected to be available in the third quarter of 2022.
Vaxart’s international Phase IB and Phase II COVID-19 trials, including a placebo-controlled efficacy trial in India, are anticipated to begin this year.
Results from Vaxart’s Phase IB trial of its norovirus vaccine candidate in elderly subjects are expected in the second quarter of 2022.
Financial Results for the Three Months Ended March 31, 2022

Vaxart ended the first quarter with cash, cash equivalents and available-for-sale debt securities of $157.0 million, compared to $182.7 million as of December 31, 2021. The decrease was primarily due to $25.1 million of cash used in operations.
The Company reported a net loss of $25.1 million for the first quarter of 2022, compared to $16.0 million for the first quarter of 2021. Net loss per share for the first quarter of 2022 was $0.20, compared to a net loss of $0.14 per share in the first quarter of 2021. The increase in net loss was primarily due to a significant increase in research and development expenses.
Revenue for the first quarter of 2022 was $85,000, compared to $506,000 in the first quarter of 2021. The decrease was due to lower royalty revenue from sales of Inavir in Japan.
Research and development expenses were $18.2 million for the first quarter of 2022, compared to $10.1 million for the first quarter of 2021. The increase was mainly due to increases in headcount and related costs and in manufacturing and clinical trial expenses related to our COVID-19 and norovirus vaccine candidates.
General and administrative expenses were $6.7 million for the first quarter of 2022, compared to $5.9 million the first quarter of 2021. The increase was mainly due to an increase in headcount and related costs.