Iovance Biotherapeutics Appoints Dan Kirby as Chief Commercial Officer to Drive Growth of Amtagvi and Proleukin

Iovance Biotherapeutics appoints Dan Kirby as Chief Commercial Officer to enhance U.S. launch of Amtagvi and Proleukin expansion.

Quiver AI Summary

Iovance Biotherapeutics, Inc. announced the appointment of Dan Kirby as the new Chief Commercial Officer, effective February 10, 2025. Frederick Vogt, the Interim President and CEO, welcomed Kirby, highlighting his extensive experience in building commercial organizations in the cell therapy sector. Kirby’s previous roles include Chief Commercial Officer at Orca Bio and Omeros Corporation, where he managed product launches and market access strategies. His expertise will support Iovance in promoting its FDA-approved TIL therapy, Amtagvi, as well as expanding Proleukin sales, positioning the company to lead in solid tumor treatments. Iovance aims to leverage its innovative TIL platform to advance cancer therapies and extend patients’ lives.

Potential Positives

• Dan Kirby's appointment as Chief Commercial Officer is significant, as he brings extensive experience in building and leading commercial strategies in the cell therapy sector, which could enhance Iovance's market positioning.
• The company is poised to expand the U.S. launch of Amtagvi and increase Proleukin sales, indicating growth potential in its product offerings.
• Iovance is recognized as a global leader in TIL cell therapy, which strengthens its brand and market credibility in the competitive oncology landscape.

Potential Negatives

• The designation of a new Chief Commercial Officer may indicate existing leadership gaps or a restructuring within the company, which could raise concerns about organizational stability.
• The press release heavily emphasizes forward-looking statements, indicating potential uncertainty regarding the company’s future performance and market acceptance of their products.
• Potential delays with approvals from the EMA or other regulatory authorities regarding lifileucel could hinder the company's strategic market expansion plans.

FAQ

What is the new role of Dan Kirby at Iovance Biotherapeutics?

Dan Kirby has been appointed as the Chief Commercial Officer to lead commercial strategies for Iovance's TIL therapies.

What are Amtagvi and Proleukin?

Amtagvi is the first FDA-approved T cell therapy for solid tumors, while Proleukin is a marketed therapy for various cancers.

What is Iovance Biotherapeutics focused on?

Iovance Biotherapeutics focuses on developing innovative tumor infiltrating lymphocyte therapies to treat solid tumors in cancer patients.

What experience does Dan Kirby bring to Iovance?

Dan Kirby has extensive experience in cell therapy commercialization, previously serving as Chief Commercial Officer at Orca Bio and Omeros Corporation.

How does Iovance intend to expand its market presence?

Iovance aims to grow the U.S. launch of Amtagvi and prepare for entry into new international markets.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

$IOVA Insider Trading Activity

$IOVA insiders have traded $IOVA stock on the open market 1 times in the past 6 months. Of those trades, 0 have been purchases and 1 have been sales.

Here’s a breakdown of recent trading of $IOVA stock by insiders over the last 6 months:

• RYAN D MAYNARD sold 50,000 shares for an estimated $503,000

To track insider transactions, check out Quiver Quantitative's insider trading dashboard.

$IOVA Hedge Fund Activity

We have seen 134 institutional investors add shares of $IOVA stock to their portfolio, and 145 decrease their positions in their most recent quarter.

Here are some of the largest recent moves:

• AVORO CAPITAL ADVISORS LLC removed 7,460,000 shares (-63.8%) from their portfolio in Q3 2024, for an estimated $70,049,400
• HOOD RIVER CAPITAL MANAGEMENT LLC added 5,412,210 shares (+198.1%) to their portfolio in Q3 2024, for an estimated $50,820,651
• T. ROWE PRICE INVESTMENT MANAGEMENT, INC. added 3,810,779 shares (+185.8%) to their portfolio in Q3 2024, for an estimated $35,783,214
• MACQUARIE GROUP LTD added 3,190,036 shares (+inf%) to their portfolio in Q3 2024, for an estimated $29,954,438
• VOLORIDGE INVESTMENT MANAGEMENT, LLC removed 2,381,706 shares (-95.6%) from their portfolio in Q3 2024, for an estimated $22,364,219
• BLACKROCK, INC. added 1,992,367 shares (+9.3%) to their portfolio in Q4 2024, for an estimated $14,743,515
• GOLDMAN SACHS GROUP INC added 1,768,248 shares (+67.4%) to their portfolio in Q3 2024, for an estimated $16,603,848

To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.

Full Release

SAN CARLOS, Calif., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that Dan Kirby will join the Company’s executive leadership team in the newly created role of Chief Commercial Officer, effective today.

“I would like to extend a warm welcome to Dan Kirby on behalf of the entire Iovance team,” stated Frederick Vogt, Ph.D., J.D., Interim President, Chief Executive Officer and board member of Iovance. “Dan has been instrumental in building and leading cell therapy commercial organizations since the earliest developments in the field. He is the perfect fit for Chief Commercial Officer as we grow the U.S. launch of Amtagvi and prepare to enter new markets around the world while also expanding our Proleukin sales.”

Prior to joining Iovance, Mr. Kirby led global commercial strategy for an emerging cell therapy platform of products as Chief Commercial Officer of Orca Bio. From 2018 to 2020, he served as Chief Commercial Officer at Omeros Corporation, overseeing U.S. and EU launch readiness for narsoplimab, a lectin pathway inhibitor, for hematopoietic stem cell transplantation-associated thrombotic microangiopathy. Previously, he led market access, reimbursement and marketing efforts for CAR T products as Vice President and Head of US Cell and Gene at Celgene (now Bristol-Myers Squibb). He joined Celgene following the acquisition of Juno Therapeutics, where he was Vice President of Marketing and Market Access. Earlier in his career, Mr. Kirby was Head of Marketing for Medivation (now Pfizer) and held various commercial roles of increasing responsibility during a 14-year tenure at Amgen. His strengths also include market engagement, reimbursement landscape evaluation, value story creation, key opinion leader outreach, communications and advocacy.

“I am pleased to join Iovance at such an exciting time as we catalyze and expand the commercial launch of Amtagvi and growth of Proleukin within the U.S. and beyond,” said Mr. Kirby. “As the global leader in TIL cell therapy, Iovance is strongly positioned to be the flagship cell therapy company for many thousands of patients with solid tumor cancers for decades to come.”

About Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics

, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are 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. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.

Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

Forward-Looking Statements

Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products, including Amtagvi, for which we have obtained U.S. Food and Drug Administration (“FDA”) approval, and Proleukin, for which we have obtained FDA and European Medicines Agency (“EMA”) approval; the risk that the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval for our marketing authorization application submission for lifileucel in metastatic melanoma; the acceptance by the market of our products, including Amtagvi and Proleukin, and their potential pricing and/or reimbursement by payors, if approved (in the case of our product candidates), in the U.S. and other international markets and whether such acceptance is sufficient to support continued commercialization or development of our products, including Amtagvi and Proleukin, or product candidates, respectively; future competitive or other market factors may adversely affect the commercial potential for Amtagvi or Proleukin; the risk regarding our ability or inability to manufacture our therapies using third party manufacturers or at our own facility, including our ability to increase manufacturing capacity at such third party manufacturers and our own facility, may adversely affect our commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk regarding the successful integration of the recent Proleukin acquisition; the risk that the successful development or commercialization of our products, including Amtagvi and Proleukin, may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain FDA, EMA, or other regulatory authority approval of, or other action with respect to, our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with the FDA, EMA, or other regulatory authorities may support registrational studies and subsequent approvals by the FDA, EMA, or other regulatory authorities, including the risk that the planned single arm Phase 2 IOV-LUN-202 trial may not support registration; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory agency input; the risk that the changing landscape of care for cervical cancer patients may impact our clinical trials in this indication; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from the FDA, EMA, or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA, EMA, or other regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities (including from our prior meetings with the FDA regarding our non-small cell lung cancer clinical trials); the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues may not continue to serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global pandemic; the effects of global and domestic geopolitical factors; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates.

CONTACTS

Iovance Biotherapeutics, Inc

:


Sara Pellegrino, IRC


Senior Vice President, Investor Relations & Corporate Communications


650-260-7120 ext. 264



Sara.Pellegrino@iovance.com

Jen Saunders


Senior Director, Investor Relations & Corporate Communications


267-485-3119



Jen.Saunders@iovance.com

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.