Monty Rakusen Iovance Biotherapeutics (NASDAQ:IOVA) is going through a favorable moment which began in the second half of February following an accelerated FDA approval for its melanoma drug Amtagvi and the pricing of an underwritten offering. By analyzing the company foundations, we can underline that, beyond the approval by the regulator, there is an unsatisfied market demand regarding metastatic melanoma and that the company has developed and integrated its production capacity internally. It is also ...

Iovance Biotherapeutics (IOVA) is a commercial-stage pharmaceutical company primarily focused on developing and marketing novel T cell-based cancer immunotherapies.Currently, Iovance has two cancer drugs in its portfolio — Amtagvi and Proleukin. While Proleukin is approved to treat two cancer indications, namely metastatic renal cell carcinoma (mRCC) and metastatic melanoma, Amtagvi is approved for advanced melanoma indication.The company is developing its pipeline candidates, consisting of tumor-infiltrati ...

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q4 2023 Earnings Conference Call February 28, 2024 4:30 PM ET Company Participants Sara Pellegrino - Senior Vice President, Investor Relations & Corporate Communications Fred Vogt - Interim President & Chief Executive Officer Jim Ziegler - Executive Vice President, Commercial Igor Bilinsky - Chief Operating Officer Friedrich Finckenstein - Chief Medical Officer Jean-Marc Bellemin - Chief Financial Officer Raj Puri - Executive Vice President, Regulatory Strategy & ...

Table of Contents 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, 2023 ☐ 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) | D ...

Financial Data and Key Metrics Changes - Revenue for Q3 2023 was $469,000, and for the nine months ended September 30, 2023, it was $707,000, compared to no revenue for the same periods in 2022 [35] - Net loss for Q3 2023 was $113.8 million or $0.46 per share, compared to a net loss of $99.6 million or $0.63 per share for Q3 2022 [60] - Research and development expenses increased to $87.5 million for Q3 2023, up from $72.5 million in Q3 2022 [61] Business Line Data and Key Metrics Changes - The company has provided TIL therapy to over 600 patients with a manufacturing success rate exceeding 90% [23] - Approximately 30 Authorized Treatment Centers (ATCs) have completed pre-approval onboarding steps to establish their TIL service line capabilities [24] Market Data and Key Metrics Changes - The advanced melanoma population in Germany, France, the U.K., and Canada is slightly larger than that in the U.S., indicating a significant market opportunity for Lifileucel [20] - More than 3/4 of advanced melanoma patients are currently insured through commercial, Medicare Advantage, and Medicare IPPS exempt segments [26] Company Strategy and Development Direction - The company aims to secure FDA approval for Lifileucel and plans to submit additional marketing applications in Europe and other regions [5][6] - The company is expanding its TIL therapy pipeline with 7 active clinical trials, including registrational trials for melanoma and lung cancer [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for Lifileucel to redefine treatment for advanced melanoma patients with no approved options [5] - The company expects to manage cash burn in the range of $320 million to $340 million for 2024, excluding one-time expenses [34][63] Other Important Information - The company had a cash position of approximately $428 million as of September 30, 2023, expected to fund operations into 2025 [9][59] - The company plans to integrate Proleukin into its treatment regimen, which is anticipated to lower clinical trial expenses and future costs associated with Lifileucel [46] Q&A Session Summary Question: Impact of a single-arm study on EU approval and reimbursement - Management indicated that the single-arm data should be sufficient for early access programs in major EU countries, with the TILVANCE-301 study providing randomized controlled trial data for reimbursement [64][65] Question: Increase in the number of authorized treatment centers - The increase in ATCs was driven by high demand from treatment centers and the extended preparation time due to the FDA delay [66] Question: Status of the review process and potential approval timeline - Management expects the BLA for Lifileucel to be approved potentially before the PDUFA date in February 2024, based on the FDA's history of approving products with unmet medical needs [72][73] Question: Manufacturing capacity and onboarding of additional centers - The company anticipates onboarding approximately 50 ATCs within 90 days of the PDUFA date, with the potential to exceed that number depending on capacity [74][75] Question: Updates on lung cancer data and future presentations - Management is focused on gathering more patient data before presenting updated lung cancer results, aiming for significant findings before sharing at a medical meeting [76] Question: Strategic portfolio prioritization and ongoing studies - Management confirmed that all ongoing studies continue, with a focus on high-priority studies like LUN-202 and TILVANCE-301, while still evaluating other programs [79][82] Question: Long-term follow-up data and patient outcomes - Management highlighted the long-term durability of responses in patients treated with Lifileucel, indicating no detrimental impact from subsequent therapies [83]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number 001-36860 (650) 260-7120 (Registrant's telephone number, including area code) Indicate by check mark whether the registran ...

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q2 2023 Earnings Conference Call August 8, 2023 4:30 PM ET Company Participants Sara Pellegrino – Senior Vice President, Investor Relations and Corporate Communications Fred Vogt – Interim President and Chief Executive Officer Igor Bilinsky – Chief Operating Officer Jim Ziegler – Executive Vice President-Commercial Friedrich Finckenstein – Chief Medical Officer Jean-Marc Bellemin – Chief Financial Officer Raj Puri – Executive Vice President, Regulatory Strategy an ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number 001-36860 IOVANCE BIOTHERAPEUTICS, INC. (Exact name of issuer as specified in its charter) 825 Industrial Road, Suite 400, San ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number 001-36860 IOVANCE BIOTHERAPEUTICS, INC. (Exact name of issuer as specified in its charter) (State or other jurisdiction of (I. ...

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q1 2023 Earnings Conference Call May 9, 2023 4:30 PM ET Company Participants Sara Pellegrino – Senior Vice President, Investor Relations and Corporate Communications Fred Vogt – Interim President and Chief Executive Officer Igor Bilinsky – Chief Operating Officer Jim Ziegler – Executive Vice President, Commercial Friedrich Finckenstein – Chief Medical Officer Jean-Marc Bellemin – Chief Financial Officer Conference Call Participants Michael Yee – Jefferies Peter La ...