On May 13, 2024 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the first quarter ended March 31, 2024 (Press release, Verrica Pharmaceuticals, MAY 13, 2024, View Source [SID1234643163]).

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"The first quarter of 2024 marked a period of significant accomplishments across our business, as we continued to expand utilization of YCANTH, received a permanent J-Code from CMS, and secured new chemical entity status from the FDA for YCANTH," said Ted White, Verrica’s President and Chief Executive Officer. "I am also pleased to report that we have seen a meaningful uptick in prescription growth and onboarding of buy and bill accounts following the listing of the permanent J-Code for YCANTH, which went into effect on April 1.

"Looking ahead, this quarter we expect to announce Phase 2 results from our lead pipeline candidate, VP-315, which is being evaluated for the treatment of basal cell carcinoma. As a potential first-in-class oncolytic peptide, VP-315 is designed to have a direct killing activity of the cancer cells, and also to stimulate the immune system to recognize, infiltrate, and attack the cancer. We expect to share data from the Phase 2 study later this quarter, and we are excited about VP-315’s potential to provide an important treatment alternative for the thousands of patients who are diagnosed each year with BCC."

Conference Call and Webcast Information

The Company will host a conference call today, Monday, May 13, 2024, at 8:30 AM, Eastern Time, to discuss its first quarter 2024 financial results and provide a business update. To participate in the conference call, please utilize the following information:

Domestic Dial-In Number: Toll-Free: 1-877-407-4018

International Dial-In Number: 1-201-689-8471

Conference ID: 13746100

Call me:

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View Source;passcode=13741589&h=true&info=company-email&r=true&B=6

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Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me link for instant telephone access to the event.

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Call me link will be made active 15 minutes prior to scheduled start time.

The call will also be broadcast live over the Web and can be accessed on Verrica Pharmaceuticals’ website: www.verrica.com or directly at View Source;tp_key=caf7d1fe6b

The conference call will also be available for replay for one month on the Company’s website in the Events Calendar of the Investors section.

Business Highlights and Recent Developments

YCANTH (VP-102)

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On March 26, 2024, the Company announced that YCANTH received New Chemical Entity ("NCE") Status and a listing in the Orange Book from the U.S. Food and Drug Administration ("FDA"), providing a minimum five years of regulatory exclusivity. The Company’s U.S. patents and pending patent applications related to YCANTH are projected to expire between 2034 and 2041, excluding any patent term adjustment or patent term extension.

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On January 29, 2024, the Company announced that the Centers for Medicare & Medicaid Services (CMS) issued a permanent J-Code (J7354) for YCANTH. Under the Healthcare Common Procedure Coding System (HCPCS) process, the J-Code for YCANTH will become fully published April 1, 2024. The Company believes that securing a permanent J-Code will accelerate utilization of YCANTH among the U.S. Medicaid and Medicare patient populations and will streamline billing and the reimbursement process.

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On January 4, 2024, the Company announced that it received the minutes from the Company’s recent Type C meeting with the FDA, which was held on November 6, 2023, to discuss the Phase 3 clinical development plan for YCANTH for the treatment of common warts. Verrica believes that the Type C meeting satisfied its objective of gaining the FDA’s advice and agreement on the overall design of a pivotal Phase 3 study of YCANTH that would support an efficacy supplement for the proposed indication of common warts.

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On January 3, 2024, the Company announced that it expanded its distribution network by entering into an agreement with Walgreen Co. to distribute YCANTH through its specialty pharmacy.

VP-315

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On January 5, 2024, the Company announced that the last patient had been dosed in Part 2 of its ongoing Phase 2 trial of VP-315, a potential first-in-class oncolytic peptide, for the treatment of basal cell carcinoma. The Phase 2 trial is a two-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, pharmacokinetics, and efficacy of VP-315 when administered intratumorally to adults with biopsy-proven basal cell carcinoma. The study is expected to enroll approximately 80 adult subjects with a histological diagnosis of basal cell carcinoma in at least one eligible target lesion. For additional information about this clinical trial, please visit clinicaltrials.gov, identifier NCT05188729.

First Quarter 2024 Financial Results

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Verrica recognized product revenue of $3.2 million in the first quarter of 2024. As commercial sales of YCANTH began in the third quarter of 2023, Verrica did not recognize any product revenue prior to that point.

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Verrica recognized collaboration revenues of $0.6 million for the three months ended March 31, 2024 related to the Collaboration and License Agreement with Torii Pharmaceutical Co., Ltd ("Torii") for supplies and development activity with Torii.

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Selling, general and administrative expenses were $16.3 million in the first quarter of 2024, compared to $4.3 million for the same period in 2023. The increase of $12.0 million was primarily due to higher expenses related to commercial activities for YCANTH, including increased compensation, recruiting fees, benefits and travel due to ramp-up of sales force of $6.2 million, increased marketing and sponsorship costs of $2.3 million, other commercial activity of $1.9 million, and increased legal costs of $0.6 million.

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Research and development expenses were $4.9 million in the first quarter of 2024, compared to $2.7 million for the same period in 2023. The increase of $2.2 million was primarily related to increased clinical costs for VP-315 of $1.5 million and increased headcount related costs of $0.6 million.

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Costs of product revenue were $0.5 million for the quarter ended March 31, 2024 including product costs of $0.2 million and obsolete inventory write-off of $0.3 million. Product costs were $0.1 million lower as some materials were expensed as research and development costs prior to FDA approval.

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Costs of collaboration revenue were $0.6 million for the quarter ended March 31, 2024, compared to $0.1 million for the quarter ended March 31, 2023. These costs of collaboration revenue consisted of payments for manufacturing supply to support development and testing services pursuant to the Torii Clinical Supply Agreement.

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Interest income was $0.6 million for the three months ended March 31, 2024, compared to $0.5 million for the same period in 2023. The increase of $0.1 million was primarily due to higher interest rates.

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Interest expense of $2.3 million for the three months ended March 31, 2024 consisted of interest expense related to the OrbiMed Credit Agreement that commenced in July 2023.

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For the quarter ended March 31, 2024, net loss was $20.3 million, or $0.44 per share, compared to a net loss of $6.6 million, or $0.15 per share, for the same period in 2023.

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For the quarter ended March 31, 2024, non-GAAP net loss was $17.8 million, or $0.38 per share, compared to a non-GAAP net loss of $5.5 million, or $0.13 per share, for the same period in 2023.

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As of March 31, 2024, Verrica had cash and cash equivalents of $48.9 million. Verrica believes that its existing cash and cash equivalents as of March 31, 2024 will be sufficient to support planned operations into the first quarter of 2025.

On May 13, 2024 Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA), a leader in PCR-based DNA technologies, and the Institute of Hematology and Blood Transfusion (ÚHKT/IHBT) reported that an abstract relating to the development of a fully enzymatic, non-viral manufacturing workflow to enable the rapid and cost-effective production of clinical-grade (GMP) CAR T-cell therapies has been accepted for presentation at the prestigious European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Hybrid Congress to be held in Madrid, Spain from June 13 – 16, 2024 (Press release, Applied DNA Sciences, MAY 13, 2024, View Source [SID1234643131]). Accepted abstracts will be available on the Congress’ website starting on May 14, 2024. This current study extends the successful results previously published on the virus-free preparation of CD19-specific CAR T-cells against refractory B cell malignancies utilizing Applied DNA’s Linea DNA.

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The current study was designed to address the high cost of conventional CAR T-cell therapies, which is primarily due to conventional manufacturing processes that utilize difficult-to-manufacture viral vectors. By generating CD123-specific CAR T-cells in a non-viral workflow via piggyBac transposons made from Linea DNA at substantial and cost-efficient yields with no risk of antibiotic-resistance gene transfer, we believe the study could offer a promising solution for the rapid manufacture of CAR T-cell therapies. IHBT is currently seeking SÚKL-EMA approval to initiate clinical trials using its Linea DNA-enabled CD123-specific CAR T-cells in patients with refractory acute myeloid leukemia.

Details of the oral presentation:
Abstract Title: "Linear DNA Platform For The Non-Viral Point-Of-Care Production Of Car-T Cells"
Abstract Number: P1722
Presenting Author: Dr. Pavel Otáhal

About the Linea DNA and Linea IVT Platforms
The Linea DNA platform is a completely cell-free DNA production platform founded on Applied DNA’s long-standing expertise in the large-scale enzymatic production of DNA. Capable of producing DNA in quantities ranging from milligrams to grams, the Linea DNA platform can produce high-fidelity DNA constructs ranging from 100bp to 20kb in size. The DNA produced via the Linea DNA platform is free of the adventitious DNA sequences found in other sources of DNA, is rapidly scalable, and provides for simple chemical modification of DNA constructs.

The Linea IVT platform combines DNA IVT templates manufacturing via the Linea DNA platform with a proprietary Linea RNAP to enable mRNA and sa-mRNA manufacturers to produce what Applied DNA believes to be better mRNA faster, with advantages over conventional mRNA production, including: 1) the elimination of plasmid DNA as a starting material; 2) the prevention or reduction of double-stranded DNA (dsRNA) contamination; and 3) simplified mRNA production workflows.

Learn more about the Linea DNA and Linea IVT platforms: LineaRx, an Applied DNA Sciences company

On May 13, 2024 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the first quarter ended March 31, 2024 (Press release, Leap Therapeutics, MAY 13, 2024, View Source [SID1234643147]).

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Leap Highlights:

· Completed $40 million private placement financing with participation from Gilead Sciences, Inc., a life sciences-focused investor, Samsara BioCapital, 683 Capital Partners, LP, Laurion Capital Management, and Rock Springs Capital
· Presented clinical data from Part A of the Phase 2 DeFianCe study evaluating DKN-01 in combination with standard of care bevacizumab and chemotherapy in second-line patients with advanced colorectal cancer (CRC), at the 2024 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium
· Expanded the ongoing randomized controlled Part B of the DeFianCe study from 130 patients to 180 patients to enhance the statistical power for patients with left-sided CRC; enrollment now expected to be completed in late Q3 or early Q4 2024
· Completed enrollment in the randomized controlled Part C of the Phase 2 DisTinGuish study evaluating DKN-01 in combination with tislelizumab and chemotherapy in patients with advanced gastroesophageal junction (GEJ) and gastric cancer; first randomized controlled data for DKN-01 expected in the second half of 2024 or early 2025

"We appreciate the strong support of Gilead and the new and existing institutional investors who participated in our recent $40 million financing that will enable the expansion and continued execution of the DKN-01 development program," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "The financing provides cash runway into the second quarter of 2026, allowing the expansion of Part B of the DeFianCe CRC study to 180 patients, the full maturation of data in Part C of the DisTinGuish GEJ/gastric cancer study, and the manufacturing of Phase 3 clinical trial material. We are well positioned for continued success and look forward to achieving major clinical milestones in the year ahead."

Business Update:

· Completed a $40 million private placement. In April 2024, Leap entered into a securities purchase agreement with a select group of institutional investors to issue and sell an aggregate of 12,660,993 shares of its common stock ("Common Stock") at a price of $2.82 per share and pre-funded warrants to purchase 1,523,404 shares of Common Stock at a price of $2.819 per share of Common Stock issuable upon exercise of the pre-funded warrants, in a private placement. Gross proceeds from the private placement were approximately $40 million with participation from new and existing investors, including Gilead Sciences, Inc., a life sciences-focused investor, Samsara BioCapital, 683 Capital Partners, LP, Laurion Capital Management, and Rock Springs Capital. The net proceeds from this financing, combined with existing cash, cash equivalents and marketable securities, are expected to fund Leap’s operating and capital expenditures into the second quarter of 2026 and enable expansion of the DKN-01 DeFianCe clinical trial and development program.

DKN-01 Development Update

· Presented initial clinical data from Part A of the DeFianCe Study of DKN-01 plus bevacizumab and chemotherapy in colorectal cancer (CRC) patients. The Company presented initial data from Part A of the DeFianCe study (NCT05480306), a Phase 2 study evaluating DKN-01 in combination with standard of care (SOC) bevacizumab and chemotherapy in second-line (2L) patients with advanced microsatellite stable (MSS) CRC patients at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, held in San Francisco on January 18-20, 2024 and during the Company’s conference call on January 23, 2024.

· Key Findings (as of the December 6, 2023 data cutoff):

o Across all patients enrolled (n=33):

§ Overall response rate (ORR) among response-evaluable patients (n=27) was 30% and disease control rate (DCR) was 93%, including 8 partial responses (PR) and 17 patients with a best response of stable disease (SD)
§ Median progression-free survival (PFS) was 6.3 months
§ 9 patients remained on therapy and were beyond 8.5 months

o Enhanced activity in patients with left-sided tumors (n=25), a group that has more frequent activation of the Wnt pathway modulated by DKK1

§ 33% ORR and 100% DCR in response-evaluable population (7 PRs, 14 SDs)
§ Preliminary median PFS of 8.6 months (9 patients continuing therapy within subgroup)

o Compelling ORR, DCR and PFS in patients with rectal/rectosigmoid carcinomas (n=15), a population with increasing incidence among young people and shown to have the highest DKK1 levels:

§ 46% ORR and 100% DCR in response-evaluable population (6 PRs, 7 SDs)
§ Preliminary median PFS of 9.4 months (6 patients continuing therapy within subgroup)
§ Higher baseline plasma DKK1 levels correlated with improved responses

o DKN-01 plus bevacizumab and chemotherapy was well-tolerated, with a majority of DKN-01 related events being low grade (Grade 1/2)

· Part B of the DeFianCe Study of DKN-01 plus bevacizumab and chemotherapy in CRC patients is ongoing, with enrollment expanded to 180 patients and expected to be completed in late Q3/early Q4 2024. The Company expanded the randomized controlled Part B of the DeFianCe study from 130 to 180 patients and included PFS in the subpopulation of patients with left-sided CRC as an additional primary endpoint. The Company expects to complete enrollment in late Q3 or early Q4 2024 with data expected in mid-2025. As of May 8, 2024, 114 patients have enrolled in Part B.

· Completion of enrollment in the randomized controlled Part C of the DisTinGuish study evaluating DKN-01 in combination with tislelizumab, BeiGene’s anti-PD-1 antibody, and chemotherapy in patients with advanced gastroesophageal junction and gastric cancer. Part C of the DisTinGuish study (NCT0436380) is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal adenocarcinoma. Part C enrolled 170 first-line, HER2-negative patients randomized 1:1 to evaluate DKN-01 in combination with tislelizumab and SOC chemotherapy, compared to tislelizumab and SOC chemotherapy alone. The primary objective is PFS in DKK1-high and in all patients. Secondary objectives of Part C include OS and ORR as measured by RECIST v1.1 in DKK1-high and in all patients. The Company expects to report initial data from Part C of the DisTinGuish study in the second half of 2024 or early 2025 when the PFS data are mature.

Selected First Quarter 2024 Financial Results

Net Loss was $13.8 million for the first quarter 2024, compared to $41.9 million for the same period in 2023. The decrease was primarily due to $29.6 million of in-process research and development ("IPR&D") expense associated with the Flame merger in January 2023.

Research and development expenses were $11.3 million for the first quarter 2024, compared to $38.9 million for the same period in 2023. The decrease of $27.6 million was primarily due to $29.6 million of IPR&D associated with the Flame merger. In addition, there was a decrease of $0.4 million in manufacturing costs related to clinical trial material manufacturing campaigns and a decrease of $0.1 million in consulting fees associated with R&D activities. These decreases were partially offset by an increase of $2.0 million in clinical trial costs and an increase of $0.5 million in payroll and other related expenses due to an increase in headcount of our R&D full-time employees.

General and administrative expenses were $3.5 million for the first quarter 2024, compared to $3.8 million for the same period in 2022. The decrease was due to a decrease of $0.3 million in professional fees associated with our business development activities.

Cash and cash equivalents totaled $54.9 million at March 31, 2024, exclusive of the $37.2 million net proceeds of the private placement completed in April 2024. Research and development incentive receivables, current portion, totaled $0.7 million at March 31, 2024.

On May 13, 2024DURECT Corporation (Nasdaq: DRRX) reported financial results for the three months ended March 31, 2024 and provided a business update (Press release, DURECT, MAY 13, 2024, View Source [SID1234643168]).

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"We are pleased that the feedback from the U.S. Food and Drug Administration (FDA) supports the advancement of larsucosterol into a single pivotal Phase 3 clinical trial which, if successful, may serve as the basis for a New Drug Application (NDA) in alcohol-associated hepatitis (AH)," stated James E. Brown, D.V.M., President and CEO of DURECT. "We are in the process of designing the registrational Phase 3 trial incorporating the FDA’s comments and insights gained from our Phase 2b AHFIRM trial. In addition, we are excited about the upcoming presentation at the European Association for the Study of the Liver (EASL) Congress 2024, which will be the first presentation of the AHFIRM data at a medical conference. We expect to provide additional details on our planned Phase 3 protocol and present new analyses from AHFIRM later in the year."

Business Update:

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During a Type C meeting with the FDA, DURECT received feedback on the recommendations for a Phase 3 clinical trial for larsucosterol in AH that could support a potential NDA filing. DURECT is in the process of designing its planned Phase 3 clinical trial based on the FDA feedback and the results from its completed Phase 2b AHFIRM clinical trial.
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DURECT announced the acceptance of a late-breaking oral presentation at the European Association for the Study of the Liver (EASL) Congress 2024 to take place June 5-8, 2024 in Milan, Italy. The presentation will feature data from the Company’s Phase 2b AHFIRM trial, which evaluated the safety and efficacy of larsucosterol as a treatment for patients with severe AH.

Financial Highlights for Q1 2024:

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Total revenues were $1.8 million and net loss was $7.6 million for the three months ended March 31, 2024 compared to total revenues of $2.1 million and net loss of $12.0 million for the three months ended March 31, 2023.
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Cash, cash equivalents and investments were $21.6 million at March 31, 2024, compared to $29.8 million at December 31, 2023. Debt at March 31, 2024 was $14.6 million, compared to $16.7 million at December 31, 2023.

Earnings Conference Call

We will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss the first quarter 2024 results and provide a corporate update:

Monday, May 13 @ 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time

Toll Free: 1-877-407-0790

International: 1-201-689-8560

Conference ID: 13746111

On May 13, 2024 Apellis Pharmaceuticals, Inc. (the "Company") reported to have entered into a financing agreement (the "Financing Agreement") with the guarantors party thereto, the lenders party thereto (the "Lenders"), and Sixth Street Lending Partners, as the administrative agent and collateral agent for the Lenders (Filing, 8-K, Apellis Pharmaceuticals, MAY 13, 2024, View Source [SID1234643207]). The Financing Agreement provides for a senior secured term loan facility of up to $475 million (the "Credit Facility"), consisting of an initial draw of $375 million at closing and a potential additional $100 million draw at the Company’s option upon satisfaction of a $50 million minimum cash requirement and a requirement that the Company’s trailing three-month sales of SYFOVRE were at least $180 million prior to the $100 million draw. The Credit Facility matures on May 13, 2030 (the "Maturity Date") and bears interest at an annual rate equal to the 3-month Secured Overnight Financing Rate (SOFR) + 5.75% (subject to 1.00% floor). Certain additional commitment and undrawn amount fees are also payable in connection with the Credit Facility.

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Apellis used the majority of the proceeds of the $375 million draw at closing to buy out its remaining obligations owed to SFJ Pharmaceuticals ("SFJ"), in the amount of approximately $326 million. The buyout of the SFJ development liability will eliminate $366 million in payments owed to SFJ, including approximately $200 million owed through 2025.

The Credit Facility does not provide for scheduled amortization payments during the term. All principal will be due on the Maturity Date. The Company will have the right to prepay loans under the Credit Facility at any time. The Company is required to repay loans under the Credit Facility with proceeds from certain asset sales, condemnation events and extraordinary receipts, subject, in some cases, to reinvestment rights. Repayments are subject to a prepayment premium.

All obligations under the Financing Agreement will be secured on a first-priority basis, subject to certain exceptions, by security interests in substantially all assets of the Company and material subsidiaries of the Company, including its intellectual property, and will be guaranteed by material subsidiaries of the Company, including foreign subsidiaries, subject to certain exceptions.

The Financing Agreement contains customary covenants, including, without limitation, a financial covenant to maintain liquidity of at least $50 million if the Company’s market capitalization is below $3 billion, and negative covenants that, subject to certain exceptions, restrict indebtedness, liens, investments (including acquisitions), fundamental changes, asset sales and licensing transactions, dividends, modifications to material agreements, payment of subordinated indebtedness, and other matters customarily restricted in such agreements. Among other permissions, the Company is permitted, on terms and conditions set forth on the Financing Agreement, to enter into a separate asset-based financing arrangement with a third party in an amount of up to $100 million, which amount is increased to $200 million upon certain sales or market capitalization thresholds, and to have outstanding convertible unsecured notes in an amount equal to the greater of $400 million and 10% of the Company’s market capitalization, but not to exceed $600 million. The Company is subject to restrictions on sales and licensing transactions with respect to its core intellectual property, defined to include SYFOVRE, EMPAVELI, and other pegcetacoplan product assets, subject to certain exceptions, including certain transactions related to areas outside the United States and Europe.

The Financing Agreement also contains certain events of default after which loans under the Credit Facility may be due and payable immediately, including payment defaults, material inaccuracy of representations and warranties, covenant defaults, bankruptcy and insolvency proceedings, cross-defaults to certain other agreements, judgments against the Company and its subsidiaries, and change of control.

The above description of the Financing Agreement and Credit Facility is a summary only and is qualified in its entirety by reference to the Financing Agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2024.