- Company to Host Conference Call at
Recent Achievements and Upcoming Milestones
- TIL therapy manufacturing in
Europeis now fully operational at PharmaCell B.V., a subsidiary of Lonza Group Ltd., in the Netherlands.
- As part of a collaboration program, Iovance and
MD Anderson Cancer Center(MDACC) initiated a new Phase 2 clinical study, 2017-0672 (NCT03449108). The clinical trial site is currently active and screening patients with soft tissue sarcoma, osteosarcoma and platinum resistant ovarian cancer. The study will treat patients with LN-145 manufactured by Iovance using the company’s Gen 2 manufacturing process.
- Enrollment in the melanoma study, C-144-01, was expanded from 60 patients to up to 85 patients, 60 of which will be in Cohort 2 utilizing the company’s Gen 2 manufacturing process. The sample size in the study was expanded as Iovance may use the study in support of a potential registration of LN-144.
- As of
May 2018, Iovance has expanded to over 50 clinical sites for its four company-sponsored studies. Of the 50 total sites, four sites are now active for the Iovance IOV-LUN-201 study to treat checkpoint naïve patients with NSCLC.
- As of
May 2018, Iovance had received approvals to commence clinical trials in six countries in Europeincluding Switzerland, the Netherlands, France, Hungary, Spainand the United Kingdom.
- In early
May 2018, the company was granted orphan-drug designation from the U.S. Food and Drug Administration( FDA) for autologous tumor infiltrating lymphocytes for the treatment of cervical cancer with a tumor size of greater than 2 cm in diameter.
- A late-breaking abstract, titled Anti-OX40 agonistic antibody enhances ex vivo CD8+ TIL expansion with increased T-cell effector function, was presented on
Monday, April 16, 2018at the American Association for Cancer Research(AACR) Annual Meeting in Chicago, IL.
- In conjunction with one of the Phase 2 clinical trials being conducted as part of Iovance’s alliance with MDACC, Iovance has access to the supply of the 4-1BB agonist antibody, urelumab, for use in the manufacturing of TIL.
- Iovance has obtained non-exclusive rights to uses of 4-1BB agonists, including uses of urelumab, in the manufacturing of TIL for adoptive cell therapy through an intellectual property license agreement with
Moffitt Cancer Center.
- The company entered into a material transfer agreement with
RXi Pharmaceuticals Corporationto evaluate potential uses of sd-rxRNA compounds in the development of TIL therapies which could be applied to various cancer types.
January 2018, the company closed an underwritten public offering of 15,000,000 shares of its common stock at a public offering price of $11.50per share, before underwriting discounts. The shares sold at closing included 1,956,521 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price less the underwriting discount. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other offering expenses payable by the company, were $172.5 millionwith net proceeds to the company of $162.0 million.
March 2018, the company announced the appointment of Michael Weiser, M.D., Ph.D., to Iovance’s Board of Directors. Dr. Weiser is the chair of Iovance’s Compensation Committee and serves on Iovance’s Nominating & Corporate Governance and Audit Committees.
First Quarter 2018 Financial Results
Net loss for the quarter ended
Research and development expenses were
General and administrative expenses were
Webcast and Conference Call
Iovance will host a conference call today at
A replay of the call will be available from
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of these trials; the timing of and our ability to obtain and maintain
Investor Relations Contact:
Stern Investor Relations, Inc.
Media Relations Contact:
|IOVANCE BIOTECHNOLOGIES, INC.|
|Selected Consolidated Balance Sheet Data|
|March 31,||December 31,|
|Cash, and cash equivalents||$||297,082||$||145,373|
|Consolidated Statements of Operations|
|(Unaudited, in thousands, except per share data)|
|For the Three Months March 31,|
|Costs and expenses*|
|Research and development expenses||19,912||15,593||(1)|
|General and administrative expenses||6,965||5,289||(1)|
|Total costs and expenses||26,877||20,882|
|Loss from operations||(26,877||)||(20,882||)|
|Net Loss Per Common Share, Basic and Diluted||$||(0.31||)||$||(0.33||)|
|Weighted-Average Common Shares Outstanding,
Basic and Diluted
|* Includes stock-based compensation as follows|
|Research and development||$||2,000||$||1,250||(1)|
|General and administrative||2,104||2,046||(1)|
|(1) Certain amounts within the statement of operations for the three months ended March 31, 2017 have been reclassified to conform with the current period presentation. These reclassifications had no impact on the Company's previously reported financial position, or cash flows for any of the periods presented.|