Iovance Biotherapeutics : 2022 Annual Report

ANNUAL REPORT

2 0 2 2

D E A R S H A R E H O L D E R S :

2022 was a pivotal year for Iovance.

We took several important steps towards achieving our mission to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for patients with cancer.

Throughout the year, we continued to prioritize our biologics license application (BLA) submission for lifileucel on behalf of patients with advanced melanoma who progress on or after anti-PD-1 therapy. There are currently no U.S. Food and Drug Administration (FDA)-approved treatment options in this setting. Our rolling BLA submission, which we initiated in August 2022, was successfully completed in March 2023. As we await FDA acceptance of our BLA for review, we believe in the strength of our clinical data, manufacturing capabilities and ability to address a significant unmet need for people with metastatic melanoma. While we continue our transition to a commercial company, we are also expanding our pre- commercial and manufacturing readiness activities to support the launch of lifileucel.

Beyond our progress with our first BLA, we continue to develop our deep immuno-oncology pipeline. Throughout 2022 and into 2023, we are executing six active clinical trials and have presented clinical data for Iovance TIL therapy in multiple solid tumor types and treatment settings. We reported and presented the clinical results from our C-144-01 trial, which is the basis for our BLA submission for lifileucel. We also initiated our first phase 3 study, TILVANCE-301, in the frontline melanoma treatment setting. We believe that our growing set of clinical data continue to demonstrate the potential for Iovance TIL therapy to become the next paradigm-shifting treatment regimen for solid tumors.

Looking toward our next generation approaches to optimize TIL therapy, we hit a key innovation milestone by treating the first patient in our first-in-human study of our first genetically modified Iovance TIL therapy, IOV-4001.

As part of our strategy to streamline and improve access to the TIL treatment regimen, we entered into a strategic transaction with Clinigen in January of 2023 to acquire worldwide rights to Proleukin®, an interleukin-2(IL-2) product. Proleukin® has currently approved indications and, importantly, is also used to promote T-cell activity following TIL infusion. The strong strategic fit and rationale for this transaction include immediate and future revenue and full control of the IL-2 supply chain and logistics surrounding TIL therapy. As a result, we expect to lower clinical trial expenses and future cost of goods for lifileucel. The closing of the transaction is subject to required regulatory approvals and clearances and other customary closing conditions.

Iovance TIL therapy (lifileucel) in Advanced (Unresectable or Metastatic) Melanoma

Our multi-pronged strategy in advanced melanoma is to address several unresectable or metastatic melanoma patient populations with significant unmet need. In post-anti-PD-1 advanced melanoma, the C-144-01 trial is the basis for our BLA submission as well as the largest single clinical study ever conducted for a cell therapy in melanoma. We presented positive data from C-144-01 Cohorts 2 and 4 to the medical community for the first time at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2022, and published results from the study in the Journal of ImmunoTherapy of Cancer (JITC) in December.

We strongly believe that the strength of the clinical data from the C-144-01 trial as well as positive regulatory interactions and feedback support approval. During 2022, we aligned with FDA on the potency assay matrix for lifileucel in melanoma and held a successful pre-BLA meeting where FDA provided favorable feedback on the clinical efficacy data from Cohorts 2 and 4, including duration of follow up and that the clinical and safety dataset was sufficient for a BLA review. In the fourth quarter, we also reached agreement with FDA for our TILVANCE-301 Phase 3 trial to serve as a registrational trial in in frontline advanced melanoma as well as a confirmatory study supporting full approval of lifileucel in post-anti-PD-1 advanced melanoma. We expect TILVANCE-301 to be well underway at the time of potential approval in this first indication.

The frontline melanoma opportunity for lifileucel is supported by positive results from Cohort 1A in our IOV-COM-202 trial of lifileucel in combination with pembrolizumab in immune checkpoint inhibitor (ICI) naive advanced melanoma and extensive prior results from the National Cancer Institute (NCI) for TIL monotherapy in anti-PD-1 naïve melanoma patients. We look forward to advancing our frontline melanoma strategy throughout 2023, including site activation and enrollment in TILVANCE-301.

TIL Manufacturing and Iovance Cell Therapy Center (iCTC)

Our manufacturing success rate is above 90% for more than 600 patients treated with Iovance TIL therapy to date. Our iCTC facility is expected to supply most commercial TIL therapies upon approval, with contract manufacturers to provide additional flexibility to optimally balance capacity and patient demand. To ensure the iCTC and our contract manufacturer's facility are well-prepared for launch, we are engaged in rigorous efforts to support successful FDA pre-approval inspections during the BLA review process. Our manufacturing teams are also focused on scaling up our internal capabilities to ensure sufficient capacity at launch.

As we look to establish TIL as the next paradigm-shifting class of cancer therapy and plan for future capacity, we have existing infrastructure at iCTC to supply TIL products for more than 2,000 patients, with flexibility to build out additional shell space to supply products for more than 5,000 patients annually from this facility. Longer-term, our vision is to build capacity for more than 10,000 patients annually by adding new facilities as well as streamlining and automating manufacturing and testing processes.

Toward Commercialization

The Iovance team has made steady progress with our commercial launch preparations for lifileucel. In addition, we are preparing for a smooth transfer and integration of Proleukin® upon the close of our planned acquisition. We are fortunate to have cross functional team members with prior Proleukin® leadership experience who are leading and developing our end-to-end integration processes.

To onboard our authorized treatment centers (ATCs) to be ready for the launch of lifileucel, our cross functional teams continue to partner with ATCs to develop new workflows that are unique to TIL therapy while leveraging workflows within existing cell therapy service lines at these ATCs. Each ATC receives targeted support, and we will coordinate just-in-time training to ensure launch readiness for multi-disciplinary teams to administer the lifileucel treatment regimen upon FDA approval. For initial launch, we aim to on-board at least 40 ATCs, with a longer-term goal to have enough sites so that most patients in the U.S. can be within a few hours' drive to an ATC offering lifileucel TIL therapy.

To further support ATCs, our IovanceCares™ program remains on track for launch to deliver a best-in-class cell ordering and patient support system that assists our patients, physicians and ATCs at every step of the process. In addition, our reimbursement strategies are focused on securing coding, coverage and payment to ensure patients have appropriate and timely access to lifileucel, with continued engagement with the key national and regional payers.

TIL Therapy in Non-Small Cell Lung and Cervical Cancers

Throughout 2022, we continued to progress our non-small cell lung cancer (NSCLC) and cervical cancer programs at Iovance. Six cohorts across three Iovance-sponsored NSCLC studies are investigating multiple treatment regimens in various populations at various stages of disease. In January of 2023, we shared initial positive topline data from Cohort 3A of the IOV-COM-202 trial, which we plan to highlight in detail at an upcoming medical meeting. Based on these positive Cohort 3A results, we plan to meet with FDA in 2023 to discuss our data and a potential registration path for lifileucel in patients with advanced NSCLC who are naïve to ICI treatment. In more advanced NSCLC patients, our IOV-LUN-202 phase 2 clinical trial is investigating LN-145 monotherapy in patients who have received prior anti-PD-1 and chemotherapy, in combination or sequentially, with an option for pre-progression tumor harvest. IOV-LUN-202, which is potentially registrational, continued to enroll patients throughout 2022 and continues enrollment this year.

We are also pleased to be moving forward with our registrational strategy for lifileucel in cervical cancer, which we updated in 2022 based on FDA feedback following a shift in the treatment landscape. In our ongoing C-145-04 trial, we expanded Cohort 2 to enroll additional patients with cervical cancer who have progressed after chemotherapy and anti-PD-1 therapy. Cohort 2 is intended to be pivotal to support regulatory approval, and we look forward to continuing Cohort 2 enrollment during 2023.

Next Generation TIL Therapies

To optimize the next generation of TIL therapies, we are developing genetically modified TIL therapies that utilize the gene-editing TALEN® technology licensed from Cellectis, S.A. to inactivate single or multiple immune checkpoint proteins that inhibit antitumor response. IOV-4001 is our first genetically modified, PD-1 inactivated TIL therapy candidate. In the third quarter of 2022, we treated the first patient with IOV-4001 in our first-in-humanIOV-GM1-201 trial in patients with previously treated advanced melanoma or NSCLC. Additional programs using the TALEN® technology are expected to enter clinical development in 2024. Other research and preclinical studies are exploring additional approaches to increase TIL potency including the selection of CD39/69 double negative TILs and enhancements such as tethered cytokines. As part of our strategy to optimize the TIL treatment regimen, we also continue IND-enabling studies for our novel IL-2 analog, IOV-3001.

Organizational Growth

In 2022, our employee population grew by 58% as we prepare to transition to a commercial stage company. We have more than 500 Iovance employees who collectively represent a breadth and depth of experience in developing and commercializing cell and gene therapy. We believe the quality of our people is a testament to the potential of our Iovance TIL therapy in solid tumors and our ability to maintain leadership within the field.

We are also committed to building and supporting a diverse workforce with a deep bench of talent and a strong corporate culture. We believe we have strong gender and ethnic diversity across our management team and overall organization. As of April 2023, women account for over 54% of the total number of manager-level or above positions and represent 55% of our total employees. Racially diverse employees (self-identifying as Black or African American, Hispanic or Latino, Asian, or two or more races) make up approximately 42% of the management-level team and 49% of our total workforce.

We remain committed to our vision of pioneering a transformational approach to cure cancer by harnessing the human immune system's ability to recognize and destroy diverse cancer cells in each patient. I am grateful for our dedicated employees, clinical investigators, collaboration partners, shareholders, and most importantly, the patients with cancer and their families who motivate us every single day.

Frederick G. Vogt, PhD, JD

Interim CEO, President, and General Counsel

G L O B A L L E A D E R I N I N N O V A T I N G ,

D E V E L O P I N G A N D D E L I V E R I N G T I L T H E R A P I E S

Iovance Biotherapeutics is pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that we hope will be a promising option for patients with cancer.

I O V A N C E I M M U N O - O N C O L O G Y P I P E L I N E

C-144-01, Cohorts 2 & 4	Rolling BLA Submitted, ODD, RMAT
TILVANCE-301 Phase 3	Confirmatory, FTD
IOV-COM-202, Cohort 1A
IOV-GM1-201, Cohort 1
IOV-LUN-202, Cohorts 1 & 2
IOV-COM-202, Cohort 3A
IOV-COM-202, Cohort 3B*
IOV-COM-202, Cohort 3C
IOV-LUN-202, Cohort 3
IOV-GM1-201, Cohort 2
C-145-04, Cohort 2	BTD, ODD
C-145-04, Cohort 3*

I O V A N C E S T R E A M L I N E D 2 2 - D A Y G M P

M A N U F A C T U R I N G P R O C E S S

1	2	3	4	5	6
Patient	Tumor Sample	Non-myeloablative	TIL	IL-2	Recovery/
Intake	Procurement	Lymphodepletion	Infusion	Infusions	Discharge

2

4

Gen 2 Process: 22 Days

I O V A N C E is committed to developing commercially available, broadly accessible cell therapies for people with cancer.

Our T-cell-based immunotherapy technology platforms are potentially applicable to many solid tumor types and blood cancers. Each platform is focused on leveraging patient- specific cells to recognize and attack diverse cancer cells that are unique to each patient.

Our lead TIL technology platform has enabled us to treat more than 600 patients using a scalable, 22-day process and other novel processes to manufacture personalized TIL therapies. With clinical data in melanoma, non-small cell lung, cervical and head and neck cancers, we believe that TIL therapy may become the next paradigm-shifting class of cancer treatment.

A P R I L 2 0 2 3

E N V I R O N M E N T A L , S O C I A L A N D

G O V E R N A N C E

( E S G ) S N A P S H O T

54%

O F M A N A G E R - L E V E L O R A B O V E P O S I T I O N S A R E W O M E N

55%

O F T O TA L E M P L O Y E E S A R E W O M E N

49%

O F E M P L O Y E E S S E L F -

I D E N T I F Y A S B L A C K O R A F R I C A N A M E R I C A N ,

H I S PA N I C O R L AT I N O ,

A S I A N , O R B E I N G 2 + R A C E S

I O V A N C E ' S

C O M M I T M E N T

T O E S G :

Maintain stringent standards for environmental stewardship

Set and achieved all workplace safety goals

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

Form 10-K

(Mark One)

• ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022

• TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transaction period from __________ to __________
  Commission file number: 001-36860

IOVANCE BIOTHERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware			75-3254381
(State or Other Jurisdiction of			(I.R.S. Employer
Incorporation or Organization)			Identification No.)
825 Industrial Road, Suite 400, San Carlos, California	94070
(Address of Principal Executive Offices)	(Zip Code)
		[phone]
		(Registrant's Telephone Number, Including Area Code)
		Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class	Trading Symbol(s)	Name Of Each Exchange
On Which Registered
Common Stock, $ 0.000041666 Par Value per Share		IOVA		The Nasdaq Global Market
		Securities registered pursuant to Section 12(g) of the Act:
		None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes  No 
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes  No	

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes  No 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes  No 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer		Accelerated filer 
Non-accelerated filer		Smaller reporting company ☐
		Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. 

If the securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. 

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b).

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)	Name of each exchange on which registered
Common stock, par value $0.000041666 per value		IOVA	The Nasdaq Stock Market, LLC

The aggregate market value of the registrant's common stock held by non-affiliates on June 30, 2022, the last business day of the registrant's most recently completed second fiscal quarter, was approximately $1.6 billion. Shares of common stock held by directors and executive officers and any ten percent or greater stockholders and their respective affiliates have been excluded from this calculation, because such stockholders may be deemed to be "affiliates" of the Registrant. This is not necessarily determinative of affiliate status of other purposes. As of February 21, 2023, there were 224,238,882 shares of the registrant's common stock outstanding.

Documents Incorporated By Reference

Portions of registrant's proxy statement relating to registrant's 2023 Annual Meeting of Stockholders (the "Proxy Statement") to be filed with the Securities and Exchange Commission pursuant to Regulation 14A, not later than 120 days after the close of the registrant's fiscal year, are incorporated by reference in Part III of this Annual Report on Form 10-K. Except with respect to information specifically incorporated by reference in this Annual Report on Form 10-K, the Proxy Statement is not deemed to be filed as part of this Annual Report on Form 10-K.

	TABLE OF CONTENTS
		Page
PART I		4
Item 1.	Business	4
Item 1A.	Risk Factors	35
Item 1B.	Unresolved Staff Comments	82
Item 2.	Properties	82
Item 3.	Legal Proceedings	84
Item 4.	Mine Safety Disclosures	84
PART II		84
Item 5.	Market for Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	84
Item 6.	[Reserved]	86
Item 7.	Management's Discussion and Analysis of Financial Condition and Results of Operations	86
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	98
Item 8.	Financial Statements and Supplementary Data	99
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	99
Item 9A.	Controls and Procedures	99
Item 9B.	Other Information	100
PART III		100
Item 10.	Directors, Executive Officers and Corporate Governance	100
Item 11.	Executive Compensation	100
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	100
Item 13.	Certain Relationships and Related Transactions, and Director Independence	100
Item 14.	Principal Accounting Fees and Services	101
PART IV		101
Item 15.	Exhibits, Financial Statements Schedules	101
Item 16.	10-K Summary	104
	Signatures	105

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Forward-Looking Statements and Market Data

This Annual Report on Form 10-K contains forward-looking statements that are based on management's beliefs and assumptions and on information currently available to management. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: "may," "will," "might," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "aim," "potential," "continue," "ongoing," "goal," "forecast," "guidance," "outlook," or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.

These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this report, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this Annual Report on Form 10-K include, but are not limited to, statements about:

• the success, cost, enrollment, and timing of our clinical trials;
• the success, cost and timing of our product development activities;
• the ability of us or our third-party contract manufacturers to continue to manufacture tumor infiltrating lymphocytes, or TIL, in accordance with our selected process;
• our ability to design, construct and staff our own manufacturing facility on a timely basis and within the estimated expenses;
• the success of competing therapies that are or may become available;
• regulatory developments in the United States of America, or U.S., and foreign countries;
• the timing of and our ability to obtain and maintain U.S. Food and Drug Administration, or the FDA, or other regulatory authority approval of, or other action with respect to, our product candidates;
• our ability to attract and retain key scientific or management personnel;
• the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
• our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates;
• the ability and willingness of our third-party research institution collaborators to continue research and development activities relating to our product candidates;
• the potential of our other research and development and strategic collaborations;
• our expectations regarding our ability to obtain and maintain intellectual property protection for our manufacturing methods and product candidates;
• our plans to research, develop and commercialize our product candidates;
• the size and growth potential of the markets for our product candidates, and our ability to serve those markets;
• our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
• fluctuations in the trading price of our common stock; and
• our use of cash and other resources.

3

Actual results may differ from those set forth in this Annual Report on Form 10-K due to the risks and uncertainties inherent in our business, including, without limitation: the FDA may not agree with our interpretation of the results of its clinical trials; later developments with the FDA that may be inconsistent with already completed FDA meetings; the preliminary clinical results, including efficacy and safety results, from ongoing Phase 2 and Phase 3 clinical trials may not be reflected in the final analyses of these clinical trials including new cohorts within these clinical trials; the results obtained in our ongoing clinical trials, such as the studies and clinical trials referred to in this Annual Report on Form 10-K, may not be indicative of results obtained in future clinical trials or supportive of product approval; regulatory authorities may potentially delay the timing of FDA or other regulatory authority approval of, or other action with respect to, our product candidates, specifically, our description of FDA interactions are subject to FDA's interpretation, as well as FDA's authority to request new or additional information; we may not be able to obtain or maintain FDA or other regulatory authority approval of its product candidates; our ability to address FDA or other regulatory authority requirements relating to our clinical programs and registrational plans, such requirements including, but not limited to, clinical and safety requirements as well as manufacturing and control requirements; risks related to our accelerated FDA review designations; our ability to obtain and maintain intellectual property rights relating to our product pipeline; and the acceptance by the market of our product candidates and their potential reimbursement by payors, if approved.

We caution you that the risks, uncertainties, and other factors referenced above may not contain all the risks, uncertainties and other factors that are important to you. In addition, we cannot guarantee future results, level of activity, performance, or achievements. Any forward-looking statement made by us in this Annual Report on Form 10-K speaks only as of the date of this Annual Report on Form 10-K or as of the date on which it is made. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise, after the date of this Annual Report on Form 10-K.

Unless the context requires otherwise, in this report the terms "Iovance," the "Company," "we," "us" and "our" refer to Iovance Biotherapeutics, Inc.

PART I

Item 1.

Business

Overview

We are a clinical-stage biopharmaceutical company pioneering a transformational approach to treating cancer by harnessing the human immune system's ability to recognize and destroy diverse cancer cells using therapies personalized for each patient. We are preparing for potential U.S. regulatory approval and commercialization of the first autologous T-cell therapy to address a solid tumor cancer. Our mission is to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte, or TIL, therapies for patients with solid tumor cancers. Our autologous TIL therapy platform uses a centralized, scalable and proprietary 22-day manufacturing process to grow polyclonal T-cells unique to each patient and yields a cryopreserved, individualized therapy. We have applied multiple TIL therapy modalities in clinical trials in solid tumors, including TIL monotherapies for patients with later stage disease who have progressed on or after standard of care, as well as TIL combinations with standard of care therapies in patients who are earlier in their disease, to potentially improve outcomes compared to current standard(s) of care.

Our lead product candidate, lifileucel, is being developed in advanced, or metastatic or unresectable, melanoma as well as in other indications. Lifileucel was investigated in two consecutive cohorts in a clinical trial of advanced melanoma patients post-anti-PD-1 therapy, including in a prospectively defined pivotal cohort. These patients had progressed on or after standard of care therapy, which is immune checkpoint inhibitors, or ICIs, and, targeted BRAF/MEK inhibitor therapy where appropriate. Based on the positive results of these cohorts, we initiated a rolling Biologics License Application, or BLA, submission to the U.S. Food and Drug Administration, or FDA, for lifileucel in August 2022. We expect to complete this rolling BLA submission in the first quarter of 2023. Our Phase 3 clinical trial of lifileucel in combination with pembrolizumab, TILVANCE-301, is intended to be registrational in frontline advanced melanoma and serve as a confirmatory clinical trial to support full approval of lifileucel monotherapy in post-anti-PD-1 melanoma.

We are also pursuing registrational strategies for lifileucel in advanced cervical cancer and for our TIL therapy, LN-145, in metastatic non-small cell lung cancer, or NSCLC. To continuously innovate and maintain our global leadership within the field, we are investigating next generation approaches to optimize TIL products, manufacturing processes and treatment regimens, including a first-in-human clinical trial of our lead genetically modified TIL therapy, IOV-4001. We are also exploring a 16-day manufacturing

4