Is this rising healthcare stock a good buy right now?There's a lot of excitement around Iovance Biotherapeutics (IOVA 0.87%) as its shares are up over 40% year-to-date. Investors and analysts both see even more upside for this mid-cap biotech stock in the long run. Today, however, the company remains deeply unprofitable, only recently obtaining approval from regulators for one of its treatments.Below, I'll look at what the business may look like five years from now, whether it could be profitable, and if it ...

Catalysts lie ahead for both of these companies.Technology stocks have led general market gains, with chip companies and software giants soaring amid excitement about the new bull market. This sort of environment favors growth stocks, so it's not surprising to see these sorts of players stand out. But if you're looking for growth, you can find it in another industry as well. I'm talking about biotech, an area bursting with innovation and potentially game-changing products.Today many of these players are tra ...

SAN CARLOS, Calif., April 19, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) ("Iovance" or the "Company"), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that on April 18, 2024 (the "Date of Grant"), the Company approved the grant of inducement stock options covering an aggregate of 79,310 shares of Iovance's common stock to thirty-seven new, non-executive ...

Let's find out if this biotech can keep up its recent momentum.Is this the start of a comeback for Iovance Biotherapeutics (IOVA -0.08%)? Though the small-cap biotech has significantly trailed the broader market in the past five years, its shares are up by 50% since 2024 started. Iovance is making progress on several fronts (more on that below).It's no wonder that many investors are increasingly excited about the company's direction. But should long-term investors put their hard-earned money into this stock ...

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 ...

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 ...

Financial Data and Key Metrics Changes - As of June 30, 2023, the company had $317.3 million in cash, cash equivalents, investments, and restricted cash, down from $478.3 million as of December 31, 2022, primarily due to cash used for the acquisition of Proleukin [7] - The net loss for the second quarter ended June 30, 2023, was $106 million or $0.47 per share, compared to a net loss of $99.3 million or $0.63 per share for the same period in 2022 [123] - Revenue for the second quarter and six months ended June 30, 2023, was $0.2 million, comprised entirely of Proleukin product sales, marking the first revenue recognition for the company [123] Business Line Data and Key Metrics Changes - Research and development expenses increased to $85.8 million for the second quarter of 2023, up from $73.4 million in the same period of 2022, driven by growth in the internal R&D team and the initiation of the Phase 3 TILVANCE-301 trial [27] - Selling, general, and administrative expenses decreased to $21.9 million for the second quarter of 2023, down from $26.3 million in the same period of 2022, primarily due to the capitalization of expenses related to the Proleukin acquisition [152] Market Data and Key Metrics Changes - The company is preparing for the commercial launch of lifileucel, with a PDUFA date set for November 25, 2023, and anticipates significant revenue from Proleukin following the launch [113][101] - The market access team is engaging key national and regional payers, expecting coverage consistent with the label and similar to recent CAR-T therapies [105] Company Strategy and Development Direction - The company aims to establish TIL therapy as a new paradigm in cancer treatment, integrating Proleukin into its offerings to enhance the TIL regimen [101] - The company is focused on expanding its clinical pipeline, with seven active clinical trials aimed at solid tumors, including ongoing studies in melanoma and non-small cell lung cancer [114] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the prospects for approval of lifileucel, citing strong clinical data and positive interactions with the FDA [4] - The company noted significant pent-up demand for lifileucel, supported by an expanded access program and ongoing engagement with patient advocacy groups [36] Other Important Information - The company has successfully provided TIL therapy for over 600 patients with a manufacturing success rate exceeding 90% [103] - The company plans to report detailed data from its IOV-COM-202 trial at the upcoming World Congress on Lung Cancer [102] Q&A Session All Questions and Answers Question: Can you provide an update on the cash runway and any internal changes? - Management indicated that the cash runway extends to the end of 2024, influenced by the recent $161 million capital raise and anticipated revenues from Proleukin and lifileucel [10] Question: What is the anticipated demand for lifileucel upon launch? - Management noted significant pent-up demand and plans to prioritize patient populations based on characteristics during the initial launch phase [18] Question: How is the onboarding process for treatment centers progressing? - The onboarding process is on track, with a goal to onboard 40 authorized treatment centers within the first 90 days post-approval [104] Question: What are the expectations regarding the FDA's review process for lifileucel? - Management reported that the FDA has not identified any major review issues and does not plan to hold an advisory committee meeting [113][137] Question: Can you elaborate on the expected efficacy benchmarks for the lung cancer trials? - Management highlighted that the overall response rate (ORR) in the lung cancer trials is promising, with specific benchmarks set against existing therapies [149]