"During the second quarter of 2017, we made significant progress with our robust immuno-oncology pipeline based on our TIL technology, and reached important milestones. Patient dosing is now ongoing in two of our three Phase 2 programs and we initiated dosing patients in cohort 2 of ourC-144-01 metastatic melanoma study, which allows for administration of LN-144 generated through a shorter manufacturing process," said Dr.
Second Quarter 2017 and Recent Highlights and Anticipated Milestones
- Corporate name changed to
Iovance Biotherapeutics : In June, the Company changed its corporate name fromLion Biotechnologies, Inc. toIovance Biotherapeutics, Inc. This new name better represents the company's leadership in the field of immuno-oncology and reflects the recent advancements in evaluating TIL therapy in new indications as well as initiatives to begin trials inEurope .
- Seeking patents for recent advancements in TIL technology: Iovance has filed for patent protection on its generation 2 TIL manufacturing process, methodsof using TIL therapies, as well as other technologies that can lead to production of better TIL products.
Clinical Trial Progress:
- Patient dosing began in second cohort of C-144-01 Phase 2 metastatic melanoma study: In May, the Company began patient dosing in the second cohort of its ongoing Phase 2 trial investigating LN-144 for the treatment of patients with metastatic melanoma. This cohort has a shorter manufacturing process, and reduces the time from excision to infusion from approximately six weeks to just over three weeks, by utilizing the company's generation 2manufacturing process which includes cryopreservation of the outbound products. Cryopreservation of the product offers greater flexibility for physicians and patients in scheduling the time of the infusion, and the shorter process increases the manufacturing flexibility leading to lower production costs.
- Two Phase 2 trials investigating LN-145 areunderway: In June, the Company began patient dosing in its Phase 2 trial of LN-145 for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The Company is also actively screening patients in the Phase 2 trial for LN-145 in cervical cancer.
- NewClinical Grant Agreement with
Moffitt Cancer Center for trial in lung cancer: In July, Iovance entered into a new Clinical Grant Agreement with theMoffitt Cancer Center to fund a Phase 1 clinical trial of TIL therapy in combination with nivolumab in metastatic non-small cell lung cancer (NSCLC) in an effort to continue to understand the potential power of TIL technology to treat various cancers in areas of high unmetmedical need.
Manufacturing Updates:
- Technology transfer initiated at PharmaCell in
the Netherlands (nowLonza ) forgeneration 1 and 2 TIL manufacturing processes: In anticipation of the initiation of clinical studies inEurope in early 2018, a technology transfer for both the generation 1 and 2 TIL manufacturing processes was commenced at PharmaCell.
- Increasing manufacturing capacity: Manufacturing at Wuxi, in suites capable of manufacturing late-stage clinical and commercial products, was initiated in May.
- Expansion of clinical trials globally: The Company engaged local health authorities in
Europe to seek feedback in support of submission of a Clinical Trial Authorisation for melanoma and cervical cancer studies in that region.
Data Presentations:
- Interim data presented at
ASCO highlighting first cohort in ongoing C-144-01 study: The Company presented a poster at the 2017American Society of Clinical Oncology (ASCO ) Annual Meeting inJune 2017 with data from 16 patients enrolled in the first cohort of its ongoing Phase 2 study of LN-144 for the treatment of metastatic melanoma. The data reported showed clinically-meaningful outcomes, of the evaluable patients, with a 29% ORR including one complete response continuing beyond 15 months post-administration of a single TIL treatment, and 77% of patients reported a reduction in target tumor size. The Phase 2 study was conducted in a heavily pre-treated patient group, all of which had received prior anti-PD-1 therapy and88% with prior anti-CTLA-4 checkpoint inhibitors, with a medianof three prior therapies. For the full data, please view the release here.
- Data to be presented at the upcoming
European Society for MedicalOncology (ESMO) 2017Congress inMadrid, Spain inSeptember 2017 : Data will be presented at the upcoming ESMO congress demonstrating phenotypic and functional characterization of TIL grown from lymphoma tumors.
Second Quarter 2017 Financial and Operating Results
As of
In connection with hiring Maria Fardis Ph.D. as the new Chief Executive Officer, on
The Companyis providing both GAAP and non-GAAP financial information. All non-GAAP information excludes amounts related to stock-based compensation. See "Use of Non-GAAP Financial Measures" below for a description of the Company's non-GAAP Financial Measures. Reconciliation between certain GAAP and non-GAAP measures is provided at the end of this press release.
GAAP and Non-GAAPNet Loss
GAAP net loss for the quarter ended
Non-GAAP net loss for the quarter ended
GAAP net loss for the six months ended
GAAP and Non-GAAP Expenses
GAAP research and development (R&D) expenses were
GAAP general and administrative (G&A) expenses were
Use of Non-GAAP Financial Measures
This press release contains non-GAAP financial measures, including expenses adjusted to exclude certain non-cash expenses. These measures are not in accordance with, or an alternative to, generally accepted accounting principles, or GAAP, and may be different from non-GAAP financial measures used by other companies. The item included in GAAP presentations but excluded for purposes of determining non-GAAP financial measuresfor the periods presented in this press release relates to the non-cash stock-based compensation expense which may fluctuate from period to period based on factors including the timing and accounting of grants for stock options and changes in the Company's stock price which impacts the fair value of options granted. The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding various financial and business trends relating to the Company's financial condition and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures, investors are provided with a more meaningful understanding of Iovance's ongoing operating performance. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating operational performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures.To the extent this release contains historical or future non-GAAP financial measures, the Company has also provided corresponding GAAP financial measures for comparative purposes. Reconciliation between certain GAAP and non-GAAP measures is provided at the end of this press release.
Webcast and Conference Call
Iovance will host a conference call today at
A replay of the call will be available one hour after the end of the call on
About
Forward-Looking Statements
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 eventsor 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 ofour ongoing clinical trials and anticipated clinical trials forour current product candidates, including statements regarding the timing of initiation and completion of the trials; the timing of and our ability to obtain and maintain
| Iovance Biotherapeutics, Inc. | |||||||
| Selected Consolidated Balance Sheet Data | |||||||
| (unaudited; inthousands) | |||||||
| June 30, | December 31, | ||||||
| 2017 | 2016 | ||||||
| Cash, cash equivalents and short-term investments | $ | 129,017 | $ | 166,470 | |||
| Total assets | $ | 138,012 | $ | 171,886 | |||
| Stockholders' equity | $ | 129,152 | $ | 166,918 | |||
| Condensed Consolidated Statements of Operations | |||||||||||||||
| (in thousands, except per share information) | |||||||||||||||
| For the Three Months Ended June 30, |
For the Six Months Ended June 30, |
||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | |||||||
| Costs and expenses* | |||||||||||||||
| Research and development | 19,653 | 4,463 | 36,276 | 8,655 | |||||||||||
| General and administrative | 3,928 | 7,264 | 8,188 | 10,082 | |||||||||||
| Total costs and expenses | 23,581 | 11,727 | 44,464 | 18,737 | |||||||||||
| Loss from operations | (23,581 | ) | (11,727 | ) | (44,464 | ) | (18,737 | ) | |||||||
| Other income | |||||||||||||||
| Interest income | 204 | 164 | 403 | 290 | |||||||||||
| Net Loss | $ | (23,377 | ) | $ | (11,563 | ) | $ | (44,061 | ) | $ | (18,447 | ) | |||
| Net Loss Per Common Share, Basic and Diluted | $ | (0.37 | ) | $ | (0.23 | ) | $ | (0.71 | ) | $ | (0.37 | ) | |||
| Weighted-Average Common Shares Outstanding, Basic and Diluted |
62,457 | 51,082 | 62,371 | 49,807 | |||||||||||
| * Includes stock-based compensation as follows | |||||||||||||||
| Research and development | $ | 1,896 | $ | 593 | $ | 3,283 | $ | 1,178 | |||||||
| General and administrative | 1,397 | 4,764 | 3,306 | 5,958 | |||||||||||
| $ | 3,293 | $ | 5,357 | $ | 6,589 | $ | 7,136 | ||||||||
| Iovance Biotherapeutics, Inc. (1) | |||||||||||||||||||
| Reconciliation of Selected GAAP Measures to Non-GAAP | |||||||||||||||||||
| (unaudited; in thousands, except per share data) | |||||||||||||||||||
| For the Three Months Ended June 30, |
For the Six Months Ended June 30, |
||||||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||||||
| Reconciliation of GAAP to non-GAAP Research and development | |||||||||||||||||||
| GAAP Research and development | $ | 19,653 | $ | 4,463 | $ | 36,276 | $ | 8,655 | |||||||||||
| Less: | |||||||||||||||||||
| Non-cash stock-based compensation (2) | (1,896 | ) | (593 | ) | (3,283 | ) | (1,178 | ) | |||||||||||
| Non-GAAP Research and development | $ | 17,757 | $ | 3,870 | $ | 32,993 | $ | 7,477 | |||||||||||
| Reconciliation of GAAP to non-GAAP General and administrative | |||||||||||||||||||
| GAAP General and administrative | $ | 3,928 | $ | 7,264 | $ | 8,188 | $ | 10,082 | |||||||||||
| Less: | |||||||||||||||||||
| Non-cash stock-based compensation (2) | (1,397 | ) | (4,764 | ) | (3,306 | ) | (5,958 | ) | |||||||||||
| Non-GAAP General and administrative | $ | 2,531 | $ | 2,500 | $ | 4,882 | $ | 4,124 | |||||||||||
| Non-GAAP Net loss reconciliation | |||||||||||||||||||
| GAAP Net loss | $ | (23,377 | ) | $ | (11,563 | ) | $ | (44,061 | ) | $ | (18,447 | ) | |||||||
| Add back: | |||||||||||||||||||
| Non-cash stock-based compensation (2) | 3,293 | 5,357 | 6,589 | 7,136 | |||||||||||||||
| Non-GAAP Net loss | $ | (20,084 | ) | $ | (6,206 | ) | $ | (37,472 | ) | $ | (11,311 | ) | |||||||
| For the Three Months Ended June 30, |
Forthe Six Months Ended June 30, |
||||||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||||||
| Non-GAAP net loss per share reconciliation | |||||||||||||||||||
| GAAP net loss per basic and diluted share: | $ | (0.37 | ) | $ | (0.23 | ) | $ | (0.71 | ) | $ | (0.37 | ) | |||||||
| Add back: | |||||||||||||||||||
| Non-cash stock-based compensation (2) | 0.05 | 0.10 | 0.11 | 0.14 | |||||||||||||||
| Non-GAAP net loss per basic and diluted share | $ | (0.32 | ) | $ | (0.13 | ) | $ | (0.60 | ) | $ | (0.23 | ) | |||||||
| Weighted-Average Common Shares Outstanding, Basic and Diluted |
62,457 | 51,082 | 62,371 | 49,807 | |||||||||||||||
- This presentation includes non-GAAP measures. The Company's non-GAAP measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read only in conjunction with its financial statements prepared in accordance with GAAP.
- All stock-based compensation was excluded for the non-GAAP analysis.
Investor Relations Contact:SarahMcCabe Stern Investor Relations, Inc. 212-362-1200 sarah@sternir.com Media Relations Contact:Evan Smith /Kotaro Yoshida FTI Consulting 212-850-5622/212-850-5690 evan.smith@fticonsulting.com kotaro.yoshida@fticonsulting.com