On May 10, 2023 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that the first patient has been dosed in Delivir, a Phase I clinical trial evaluating TG6050 (Press release, Transgene, MAY 10, 2023, View Source;First-Patient-Dosed-in-Phase-I-Trial-Evaluating-TG6050-a-Novel-IL-12-Armed-Oncolytic-Virus-Administered-Intravenously-in-Non-Small-Cell-Lung-Cancer [SID1234631409]). This multi-mechanism oncolytic immunotherapy is administered intravenously in patients with recurrent metastatic advanced non-small cell lung cancer (NSCLC).

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TG6050 seeks to overcome tumor resistance by initiating an antitumor response through multiple mechanisms of action that include oncolysis, the induction of an immune response together with high intra-tumoral concentrations of IL-12 and anti-CTLA4 antibody.

The Delivir trial will enroll up to 36 patients with advanced NSCLC who have failed standard therapeutic options, including immune checkpoint inhibitors. The IV route is considered the most appropriate route of administration for this patient population with disseminated disease and multiple overt and occult metastases. Completion of the trial is expected in H2 2024.

The potential for IV administration of Transgene’s patented Invir.IO platform has been seen in the data presented for TG6002. TG6050 will build on the safety profile of Transgene’s backbone while enhancing the therapeutic potential of its two highly immunogenic payloads – IL-12 and a full length anti-CTLA-4 antibody – while limiting exposure to their systemic toxicity.

"We are pleased to initiate this first-in-human trial of TG6050 administered intravenously in patients with recurrent/metastatic advanced non-small cell lung cancer in great need for effective new therapeutic options," said Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. "Intravenous administration of TG6050 aims at significantly enhance the therapeutic potential of this promising oncolytic virus as it allows a targeted approach to many internal cancer lesions and metastases inaccessible by intratumoral injection. With its multiple mechanisms of action – including oncolysis, the induction of an immune response together with high intra-tumoral concentrations of IL-12 and anti-CTLA4 antibody – and its ability to be administered intravenously, TG6050 has several competitive advantages. We look forward to progressing this trial and delivering clinical results for this promising new oncolytic virus."

Efficacy and safety of TG6050 were demonstrated in preclinical and toxicology studies in non-human animal models. Initial data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 14 -19, 2023 and can be accessed here.

About the Delivir trial (NCT: NCT05788926)

The Delivir trial is a multicenter, open label, dose-escalation Phase I trial evaluating TG6050 as a single agent. The trial will enroll up to 36 patients with metastatic/advanced non-small cell lung cancer (NSCLC), who have failed standard therapeutic options including immunotherapies such as immune checkpoint inhibitors. Patients will receive single and repeated escalating doses of TG6050 administered intravenously, to determine the recommended dose and best schedule of administration for subsequent clinical development.

About TG6050

TG6050 is an oncolytic virus developed with Transgene’s Invir.IO platform for intravenous administration. Invir.IO’s viruses are based on the patented large capacity Vaccinia virus Copenhagen strain genetically modified with the double deletion TK-RR- (VVCOPTK-RR-). TG6050 has been engineered to encode human IL-12, a cytokine that triggers a powerful antitumor immune response and a full length anti-CTLA4 antibody. It has also been optimized with the deletion of the gene encoding for the M2L viral protein that targets CD80 and CD86, two ligands of CTLA4 [source: Kleinpeter et al., J Virol. 2019 Jun 1; 93(11): e00207-19]. The use of an oncolytic virus to deliver these immunotherapies locally and selectively in the tumor microenvironment allows high intratumoral concentrations of both therapeutic proteins eliciting a stronger and more effective antitumor response. By reducing systemic exposure to a very low level, this local therapeutic activity furthermore allows to increase the safety and tolerability profile of IL-12 and the anti-CTLA4 antibody.
It is evaluated in the Delivir trial, a Phase I trial conducted in advanced NSCLC patients.
A short video detailing TG6050’s mechanism of action can be found here.

On May 10, 2023 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a leading T-cell receptor (TCR) cell therapy company advancing a clinical-stage pipeline of therapeutics for solid tumors, reported financial results for the first quarter ended March 31, 2023, and provided a corporate update (Press release, Alaunos Therapeutics, MAY 10, 2023, View Source [SID1234631408]).

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"Our TCR-T Library Phase 1/2 trial continues to garner significant interest among patients, physicians and investigators," said Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. "We’ve been actively enrolling patients and manufacturing cryopreserved products, and we expect to report interim clinical data in the third quarter of this year. As we work to fully realize the long-term potential of our TCR-T platform, we have simplified our corporate structure with the full prepayment of our loan with SVB and the recent agreement with Precigen. We are now moving forward unencumbered by debt or these potential royalties as we seek to transform the treatment of solid tumors."

Recent Developments and Upcoming Milestones

TCR-T Library Phase 1/2 trial actively enrolling patients: Alaunos continues to actively enroll patients in its TCR-T Library Phase 1/2 trial targeting KRAS, TP53 and EGFR driver mutations across six solid tumor indications. Early translational data from the first three patients treated in the program will be highlighted in a poster at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6, 2023. Alaunos currently expects to provide an interim data update on multiple new patients in the third quarter of this year as the Company advances the program towards Phase 2 readiness with a recommended Phase 2 dose anticipated by year end 2023.

Manufactured multiple cryopreserved products: In the first quarter of 2023, Alaunos enhanced its manufacturing process to move from fresh to cryopreserved cell product enabling greater flexibility for patient scheduling and treatment. To date, the Company has manufactured multiple cryopreserved products with viability, purity and TCR positivity comparable to our prior process.

Completed full prepayment of amended loan and security agreement with Silicon Valley Bank (SVB): In May 2023, Alaunos fully prepaid the remaining amounts owed under its term loan with SVB, which was $11.0 million as of March 31, 2023. With no remaining obligations due to SVB, the restricted cash balance of $13.9 million as of March 31, 2023, has also been released.

Amended exclusive license agreement with Precigen, Inc.; Alaunos maintains exclusive rights to TCRs using Sleeping Beauty targeting driver mutations: In April 2023, Alaunos amended its exclusive license agreement with Precigen. Under the terms of the amended agreement, Alaunos maintains exclusive rights to TCRs using Sleeping Beauty targeting driver mutations, while Precigen regains the rights to its CAR-T and IL-12 assets. The amended agreement eliminated all commercial sales-based royalties and milestone obligations, in alignment with Alaunos’ focus on its priority TCR-T programs.

Expanded infrastructure of hunTR TCR discovery platform to increase throughput; expect to add three new TCRs in 2023: In the first quarter of 2023, Alaunos significantly increased the throughput potential of its hunTR TCR discovery platform to further accelerate TCR discovery and validation. New lab equipment and advanced bioinformatics capabilities have multiplied the screening throughput while maintaining a high success rate of TCR discovery. The Company expects to add three new TCRs to its library, potentially bringing the total number of unique TCRs to 15 by the end of 2023.

Appointed Robert Hofmeister, PhD, MS, to Board of Directors: In March 2023, Alaunos appointed Robert J. Hofmeister, PhD, MS, to the Company’s board of directors. Dr. Hofmeister brings deep expertise in the discovery and development of engineered T-cell receptor therapies as well as a background in cellular immunology and translational science. He is currently Chief Scientific Officer of a stealth early-stage biotechnology company and was most recently Chief Scientific Officer at TCR2 Therapeutics.

First Quarter Ended March 31, 2023, Financial Results

Research and Development Expenses: Research and development expenses were $6.5 million for the first quarter of 2023, compared to $5.6 million for the first quarter of 2022, an increase of approximately 17%. The increase was primarily due to incremental manufacturing activities related to the TCR-T Library Phase 1/2 trial and hunTR research efforts of $1.7 million, partially offset by a $0.7 million decrease in employee-related expenses.

General and Administrative Expenses: General and administrative expenses were $3.2 million for the first quarter of 2023, compared to $3.5 million for the first quarter of 2022, a decrease of approximately 10%. The decrease was primarily due to lower professional fees of $0.2 million.

Net Loss: Net loss was $10.0 million, or $(0.04) per share, for the first quarter of 2023, compared to a net loss of $9.8 million, or $(0.05) per share, for the first quarter of 2022.

Cash, Cash Equivalents and Restricted Cash: As of March 31, 2023, Alaunos had approximately $37.4 million in cash balances, which included restricted cash of approximately $13.9 million. Based on current operating plans, the Company expects its operating outflows, excluding debt service costs, for 2023 to be between approximately $35 million and $40 million. The Company expects to have sufficient cash resources to fund research and development programs and operations into the fourth quarter of 2023.

Conference Call and Webcast

Alaunos will host a conference call and webcast today, May 10, 2023, at 9:00 a.m. ET. Participants may access the live webcast using the link here or by visiting the "Investors" section of the Alaunos website at www.alaunos.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. The event will be archived on the Company’s website for approximately 30 days after the call.

On May 10, 2023 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the quarter ended March 31, 2023, and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, MAY 10, 2023, View Source [SID1234631407]).

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"We believe that azenosertib has the potential to benefit large numbers of patients who are facing difficult-to-treat cancers. As a result, our highest priority remains the successful execution of our development strategy for this promising therapeutic," said Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis. "We began the year by initiating enrollment in our Pfizer-partnered clinical trial combining azenosertib with the BEACON regimen in BRAF V600E mutant metastatic colorectal cancer. At AACR (Free AACR Whitepaper) in April, we presented preclinical data supporting the use of CCNE1 amplification and/or Cyclin E1 expression as a potential marker for the enrichment of patient populations for treatment with azenosertib. We are driving toward two additional milestones for azenosertib in the first half of the year – disclosing our monotherapy dose, and sharing positive clinical data from our chemotherapy combination trial in ovarian cancer at ASCO (Free ASCO Whitepaper) in June."

The Company also announced the appointment of Diana Hausman, M.D., to the Board of Directors. "I share Zentalis’ passion and commitment to developing therapeutics for difficult-to-treat cancers," said Dr. Hausman. "I believe azenosertib has the potential to be a game-changing therapeutic for cancer patients, and I look forward to working with the other members of the Board and the Zentalis management team to help the Company achieve its goals."

WEE1 Inhibitor (Azenosertib) Program Highlights

•On track to announce monotherapy dose in first half 2023. The Company is optimizing monotherapy dosing across the azenosertib program with the goal of maximizing exposure and tolerability, as well as enabling the potential clinical benefits of the agent to reach the broadest range of patients. The Company remains on track to provide an update on azenosertib monotherapy dosing in the first half of 2023.

•Company to present positive chemotherapy combination data at 2023 ASCO (Free ASCO Whitepaper) Annual Meeting. The Company will present results from its Phase 1b chemotherapy combination trial in ovarian cancer, which will include Cyclin E1 translational data, at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, on June 5, 2023.

•Preclinical support for Cyclin E1 as a predictive marker presented at AACR (Free AACR Whitepaper). Zentalis identified high Cyclin E1 protein expression and/or CCNE1 gene amplification in high-grade serous ovarian cancer as a patient enrichment strategy for azenosertib, which is currently enrolling its Phase 2 clinical study in high-grade serous ovarian cancer. In April, the Company presented preclinical data supporting the rationale for the Cyclin E1 enrichment strategy at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023.

•Initiated mCRC study in collaboration with Pfizer. As previously disclosed, in the first quarter of 2023, Zentalis initiated enrollment for its Phase 1/2 dose escalation study of azenosertib in combination with encorafenib and cetuximab (BEACON regimen) in BRAF V600E mutant metastatic colorectal cancer (mCRC) patients. Zentalis is collaborating with Pfizer Inc. on this study.

•Collaborations with Foundation Medicine and Roche Diagnostics. In April, the Company announced separate agreements with Foundation Medicine, Inc., an independent affiliate of the Roche Group, and with Roche Diagnostics. The current Foundation Medicine partnership involves global prospective genomic profiling for potential patient enrollment in Zentalis’ Phase 2 clinical trial of azenosertib in Cyclin E1 driven high-grade serous ovarian cancer. The Roche Diagnostics agreement is focused on the development of an immunohistochemistry-based clinical trial assay that evaluates Cyclin E1 protein levels and that can potentially identify a broader patient population with high protein expression in the absence of amplification.

BCL-2 Inhibitor (ZN-d5) 2023 Milestones

•Amyloidosis study. As previously communicated, Zentalis plans to announce interim clinical data and disclose the dose for the Phase 1/2 monotherapy clinical trial of ZN-d5 in relapsed or refractory light chain (AL) amyloidosis in the second half of 2023.

•AML study. The Company has initiated a Phase 1/2 combination study of ZN-d5 and azenosertib in relapsed or refractory acute myeloid leukemia (AML) and, as previously disclosed, expects to provide preliminary data from the trial in the second half of 2023.

Corporate Highlights

•In May 2023, the Company appointed Diana Hausman, M.D., to its Board of Directors. Dr. Hausman is an oncologist with extensive experience in all aspects of drug development, including development and implementation of clinical strategy. Dr. Hausman is currently serving as Chief Medical Officer of Link Immunotherapeutics. Dr. Hausman previously served as Chief Medical Officer of Lengo Therapeutics, Zymeworks and Oncothyreon. Prior to Oncothyreon, Dr. Hausman held positions of increasing responsibility at ZymoGenetics, Berlex Laboratories and Immunex. Dr. Hausman currently serves on the Board of Directors of Immuneering.

•In February 2023, the Company appointed Funda Meric-Bernstam, M.D., a widely recognized Phase 1 trial expert and experimental therapeutics researcher in oncology, to its Scientific Advisory Board. Dr. Meric-Bernstam is the Chair of the Department of Investigational Cancer Therapeutics — the Phase 1 Program at The University of Texas MD Anderson Cancer Center.

Her clinical research is focused on novel therapeutics, novel combination therapies and biomarkers to predict and monitor drug response.

First Quarter 2023 Financial Results

•Cash and Marketable Securities Position: As of March 31, 2023, Zentalis had cash, cash equivalents and marketable securities of $392 million. The Company believes that its existing cash, cash equivalents and marketable securities as of March 31, 2023 will be sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2025.

•Research and Development Expenses: Research and Development Expenses: Research and development (R&D) expenses for the quarter ended March 31, 2023 were $48.6 million, compared to $46.1 million for the three months ended March 31, 2022. The increase of $2.5 million was primarily due to a $3.2 million increase in overhead allocations driven by an operating lease impairment charge, and an increase of $1.9 million in personnel costs. These increases were partially offset by a $1.8 million decrease in clinical trial-related costs and $0.8 million in decreased collaborative costs.

•General and Administrative Expenses: General and administrative (G&A) expenses for the quarter ended March 31, 2023 were $16.4 million, compared to $11.8 million during the three months ended March 31, 2022. This increase of $4.6 million was primarily attributable to a $5.0 million operating lease impairment charge and a $3.0 million increase in personnel costs, of which $2.7 million was non-cash stock-based compensation. These increases were partially offset by $3.1 million related to the allocation of overhead expenditures, and net reductions in outside services and supplies of $0.3 million.

About Azenosertib

Zentalis’ azenosertib (ZN-c3) has been designed to be a highly potent and selective WEE1 inhibitor.
Azenosertib is currently being evaluated in the clinic for advanced solid tumors and hematological malignancies in the following three therapeutic settings of high unmet medical need: (1) as a monotherapy, (2) in combination with traditional chemotherapy and DNA damaging agents, and (3) in combination with molecularly targeted agents. As a monotherapy, azenosertib is currently being evaluated in a Phase 2 clinical trial in adult women with uterine serous carcinoma (USC), an aggressive form of endometrial cancer that accounts for approximately 10-15% of all endometrial cancers. We are also evaluating azenosertib as a monotherapy in a Phase 2 clinical trial in patients with Cyclin E1 driven high-grade serous ovarian cancer (HGSOC). The Company is evaluating azenosertib as a monotherapy in a Phase 1 dose optimization clinical trial in patients with advanced solid tumors, and plans to disclose the monotherapy dose and provide an update on dose optimization activities in the first half of 2023. In chemotherapy combinations, azenosertib is currently being evaluated in combination with each of paclitaxel, carboplatin, pegylated liposomal doxorubicin (PLD) and gemcitabine in four cohorts in a Phase 1b clinical trial in patients with advanced platinum-resistant ovarian, peritoneal or fallopian tube cancer. The Company plans to disclose results from this study in the first half of 2023, in advance of original guidance. Azenosertib is also currently being evaluated in combination with gemcitabine in a Phase 1/2 clinical trial in adult and pediatric patients with relapsed or refractory osteosarcoma. In combination with molecularly targeted agents, the Company is studying azenosertib in combination with GlaxoSmithKline plc’s (GSK’s) PARP inhibitor, niraparib (ZEJULA), in a Phase 1/2 clinical trial in platinum-resistant ovarian cancer patients who have failed PARP inhibitor maintenance treatment as part of a clinical collaboration with GSK. The Company is also collaborating with Pfizer Inc. to evaluate azenosertib in combination with encorafenib and cetuximab, an FDA-approved standard of care known as the BEACON regimen, in patients with BRAF V600E mutant metastatic colorectal cancer in a Phase 1/2 clinical trial.

On May 10, 2023 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported its financial results and a business update for the first quarter ended March 31, 2023 (Press release, VolitionRX, MAY 10, 2023, View Source [SID1234631406]). Volition management will host a conference call tomorrow, May 11 at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details can be found below.

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"It has been a phenomenal start to the year, with the launch of our Nu.Q Vet Cancer Test through IDEXX’s reference laboratory network. It is also available as the Heska Nu.Q Canine Cancer Screen and Monitor test through Heska’s veterinary diagnostic laboratory and for pre-order at the point of care. Without a doubt, establishing global supply agreements with two global industry leaders offers what we expect to be significant revenue opportunities for Volition, and we are delighted to report a 381% increase in sales to $124,000 of the Nu.Q Vet Cancer Test for the first quarter compared to the previous year.

"Our goal is to make canine cancer screening and monitoring accessible worldwide and we are moving ever closer to realizing our mission as we are expecting launches in additional countries this year," commented Cameron Reynolds, President and Group Chief Executive Officer of Volition.

"We also continued to work diligently in our efforts to bring Nu.Q NETs to market, and we are now undertaking large-scale finding studies across multiple sites in the U.S. to determine clinical utility in sepsis and support an application to the FDA’s Breakthrough Device Program. We believe that the Nu.Q NETs test is a ground-breaking diagnostic aid that clinicians can use to detect the diseases associated with NETosis and anticipate that this will be a pivotal year as we progress towards commercialization."

Volition is hosting a Capital Markets Day at the New York Stock Exchange, in a hybrid format, tomorrow, Thursday May 11, at 2:00 p.m. U.S. Eastern Time. Volition’s executive team will provide strategic updates on both Nu.Q NETs and Nu.Q Vet and will be joined by Key Opinion Leaders: Dr. Andy Retter (Intensive Care Consultant); Veterinary Oncologists, Professor Heather Wilson-Robles and Dr. Sue Ettinger. Details for this event can be found below.

Financial Highlights

·

Cash and cash equivalents as of March 31, 2023, totaled approximately $10 million compared with $10.9 million at the end of 2022.

·

Received approximately $8 million net of underwriter’s fees and commissions in cash through an underwritten public offering of its common stock in February.

·

Expect to receive a further $13 million in milestone payments from Heska Corporation and additional funding, including non-dilutive funding, from three Belgian agencies, in the coming months.

Event: VolitionRx Limited First Quarter 2023 Earnings and Business Update Conference Call

Date: Thursday, May 11, 2023

Time: 08:30 a.m. U.S. Eastern Time

U.S. & Canada Dial-in: 1-877-407-9716 (toll free)

U.K. Dial-in: 0 800 756 3429 (toll free)

Toll/International: 1-201-493-6779

Conference ID: 13738662

Cameron Reynolds, President and Group Chief Executive Officer of Volition, will host the call along with Terig Hughes, Group Chief Financial Officer, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on important events which have taken place in the first quarter of 2023 and upcoming milestones.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until May 25, 2023. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13738662.

On May 10, 2023 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the first quarter ended March 31, 2023, and provided updated full-year 2023 financial guidance (Press release, Vericel, MAY 10, 2023, View Source [SID1234631405]).

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First Quarter 2023 Financial Highlights

•Total net revenue of $41.0 million
•MACI net revenue of $34.2 million and Epicel net revenue of $6.8 million
•Gross margin of 65%
•Net loss of $7.5 million, or $0.16 per diluted share
•Non-GAAP adjusted EBITDA of $1.7 million
•Operating cash flow of $7.9 million
•As of March 31, 2023, the Company had approximately $139 million in cash and investments, and no debt

Business Highlights and Updates
•Record first quarter total revenue
•Highest first quarter MACI revenue since launch, representing growth of 32% compared to the prior year
•Highest number of surgeons taking MACI biopsies and second highest number of MACI biopsies in a quarter since launch
•11th straight quarter of positive adjusted EBITDA and operating cash flow
•MACI arthroscopic delivery program remains on track for an anticipated 2024 commercial launch
•Tracking ahead of initial goals on NexoBrid Pharmacy and Therapeutics (P&T) committee submissions and approvals at target burn centers
1
Exhibit 99.1
•NexoBrid selected for inclusion in the pre-conference healthcare professional educational sessions at the upcoming American Burn Association (ABA) annual meeting with hands-on lab demonstrations by leading burn surgeons
"The Company had a very strong start to the year, delivering record quarterly MACI and total revenue and another quarter of profitability and operating cash flow," said Nick Colangelo, President and CEO of Vericel. "MACI has continued on its high-growth trajectory with first quarter revenue growth of more than 30% and, based on our positive first quarter performance and strong underlying business fundamentals, we have increased our 2023 full-year revenue guidance. We look forward to the upcoming commercial launch of NexoBrid and continue to advance the MACI arthroscopic delivery program, which we believe will drive further growth in the years ahead."

2023 Financial Guidance
•Total net revenue for 2023 now expected to be in the range of $184 to $192 million compared to the previous guidance of $180 to $188 million
•Maintaining profitability guidance of gross margin in the high-60% range and adjusted EBITDA margin in the mid-teens % range
First Quarter 2023 Results
Total net revenue for the quarter ended March 31, 2023 increased 14% to $41.0 million, compared to $36.1 million in the first quarter of 2022. Total net product revenue for the quarter included $34.2 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $6.8 million of Epicel (cultured epidermal autografts) net revenue, compared to $26.0 million of MACI net revenue and $9.9 million of Epicel net revenue, respectively, in the first quarter of 2022.
Gross profit for the quarter ended March 31, 2023 was $26.5 million, or 65% of net revenue, compared to $23.5 million, or 65% of net revenue, for the first quarter of 2022.
Total operating expenses for the quarter ended March 31, 2023 were $34.7 million, compared to $30.7 million for the same period in 2022. The increase in operating expenses was primarily due to an increase in employee-related expenses and higher sales and marketing expenses.
Net loss for the quarter ended March 31, 2023 was $7.5 million, or $0.16 per diluted share, compared to $7.1 million, or $0.15 per diluted share, for the first quarter of 2022.
Non-GAAP adjusted EBITDA for the quarter ended March 31, 2023 was $1.7 million, or 4% of net revenue, compared to $3.2 million, or 9% of net revenue, for the first quarter of 2022. A table reconciling non-GAAP measures is included in this press release for reference.

Exhibit 99.1
As of March 31, 2023, the Company had approximately $139 million in cash and investments, and no debt.
Conference Call Information
Today’s conference call will be available live at 8:30am Eastern Time and can be accessed through the Investor Relations section of the Vericel website at View Source A slide presentation with highlights from today’s conference call will be available on the webcast and in the Investor Relations section of the Vericel website. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software, if necessary. To participate by telephone, please register here to receive dial-in details and your personal passcode. A replay of the webcast will be available on the Vericel website until March 31, 2024.