“We ended 2017 having completed significant accomplishments involving both manufacturing and clinical aspects of development of TIL as a viable commercial therapy. We developed a new manufacturing method, lasting 22 days and yielding a cryopreserved product, conducted a clinical study investigating the efficacy of this method, reported preliminary data showing responses from this generation 2 manufacturing method in late-line metastatic melanoma patients and subsequently selected this manufacturing method for all ongoing and future clinical trials for Iovance. We have also expanded our manufacturing capacity in the US, in commercial-ready suites, and built out our capacity in the EU. On the clinical front, we are currently running four studies to evaluate the potential breadth of utility of TIL therapy in multiple indications,” said Dr.
2017 Achievements and 2018 Updates
Manufacturing
- Completed development of the generation 2 manufacturing method and the associated technology transfer into multiple CMOs in the US and the EU.
- Entered into a new three-year Manufacturing Services Agreement (MSA) with
PharmaCell B.V. , now a subsidiary ofLonza Group Ltd. , inthe Netherlands to support EU manufacturing. PharmaCell is now able to receive clinical samples and manufacture TIL therapy for patients. - Entered into a new two-year MSA with
H. Lee Moffitt Cancer Center andResearch Institute (Moffitt). - Commenced a partnership with
TrakCel Ltd. to build a scheduling and logistics software tool that automates the supply chain for the company’s TIL therapy.
Clinical
- Presented clinical data from the first cohort of the company’s Phase 2 trial investigating LN-144 for the treatment of patients with metastatic melanoma, known as C-144-01, at the 2017 ASCO Annual Meeting in June.
- Began patient dosing in the second cohort of C-144-01 and reported preliminary data at the SITC Annual Meeting in November.
- Began patient dosing in C-145-03, the company’s Phase 2 trial of LN-145 for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck and reported preliminary data from this study in
January 2018 . - Began patient dosing in C-145-04, the company’s Phase 2 trial of LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma and provided early response data from evaluable patients in early 2018 as well.
- Entered into a new clinical grant agreement with Moffitt to provide funding for a clinical study of TIL therapy in non-small cell lung cancer (NSCLC) and Moffitt began patient enrollment in this study in patients with advanced NSCLC cancer combining TIL and nivolumab in patients who have progressed on nivolumab.
- First site was activated in the Iovance IOV-LUN-201 study to treat checkpoint naïve patients with NSCLC.
- Entered into a multi-year strategic alliance with
M.D. Anderson . - First clinical site was activated in
Europe for the C-144-01 melanoma study.
Regulatory
- Received Fast Track designation in the U.S. for LN-144 for the treatment of advanced melanoma.
- Submitted Clinical Trial Applications in multiple countries in Europe in support of the company’s Phase 2 clinical trials and received multiple approvals to commence clinical trials in
Europe .
Research
- Entered into a collaboration with the
Ohio State University Comprehensive Cancer Center –Arthur G. James Cancer Hospital and Richard J. Solove Research Institute to evaluate TILs, marrow infiltrating lymphocytes (MILs), and peripheral-blood associated lymphocytes in acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL). - Late-breaking abstract, titled Anti-OX40 agonistic antibody enhances ex vivo CD8+ TIL expansion with increased T-cell effector function, accepted for presentation at the
American Association for Cancer Research Annual Meeting 2018. The poster will be available onApril 16, 2018 .
Corporate
- Changed corporate name from
Lion Biotechnologies, Inc. toIovance Biotherapeutics, Inc. and reincorporated from aNevada corporation to aDelaware corporation. - Appointed
Timothy E. Morris as the company’s chief financial officer inAugust 2017 . - Raised approximately $53.7 million in net proceeds, after deducting underwriting discounts and offering expenses, through a public offering that closed in
September 2017 . - In
January 2018 , the company closed an underwritten public offering of 15,000,000 shares of its common stock at a public offering price of$11.50 per 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 estimated offering expenses payable by the company, were$172.5 million with estimated net proceeds to the company of approximately$161.7 million .
Fourth Quarter and Full-Year 2017 Financial and Operating Results
At
Iovance anticipates cash, cash equivalents and investments to be between
The company is 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-GAAP Net Loss Attributable to Common Stockholders
GAAP net loss attributable to common stockholders for the quarter ended
Non-GAAP net loss attributable to common stockholders for the quarter ended
GAAP net loss attributable to common stockholders for the year 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 (GAAP), and may be different from non-GAAP financial measures used by other companies. The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in this press release are: (i) 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, and (ii) the one-time non-cash deemed dividend related to the conversion feature of the Series B Preferred Stock. 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. Beginning in 2018, Iovance will no longer report non-GAAP expenses or non-GAAP net loss per share.
Webcast and Conference Call
Iovance will host a conference call today at
A replay of the call will be available from
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 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. These forward-looking statements include, but are 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 the trials; the timing of and our ability to obtain and maintain
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Iovance Biotherapeutics, Inc. | |||||
Selected Consolidated Balance Sheet Data | |||||
(unaudited; in thousands) | |||||
December 31, | December 31, | ||||
2017 | 2016 | ||||
Cash, cash equivalents and short-term investments | $ | 145,373 | $ | 166,470 | |
Total assets | $ | 155,373 | $ | 171,886 | |
Stockholders' equity | $ | 145,481 | $ | 166,918 | |
Condensed Consolidated Statements of Operations | ||||||||||||||||||
(unaudited; in thousands, except per share data) | ||||||||||||||||||
For the Three Months Ended December 31, |
Year Ended December 31, |
|||||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||||
Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||||
Costs and expenses* | ||||||||||||||||||
Research and development | 20,696 | 10,119 | 71,615 | 26,941 | ||||||||||||||
General and administrative | 5,375 | 5,804 | 21,262 | 26,698 | ||||||||||||||
Total costs and expenses | 26,071 | 15,923 | 92,877 | 53,639 | ||||||||||||||
Loss from operations | (26,071 | ) | (15,923 | ) | (92,877 | ) | (53,639 | ) | ||||||||||
Other income | ||||||||||||||||||
Interest income | 217 | 234 | 813 | 745 | ||||||||||||||
Net Loss | $ | (25,854 | ) | $ | (15,689 | ) | $ | (92,064 | ) | $ | (52,894 | ) | ||||||
Deemed dividend related to beneficial conversion feature of convertible preferred stock | - | - | - | (49,454 | ) | |||||||||||||
Net Loss Attributable to Common Stockholders | (25,854 | ) | (15,689 | ) | (92,064 | ) | (102,348 | ) | ||||||||||
Net Loss Per Common Share, Basic and Diluted | $ | (0.36 | ) | $ | (0.25 | ) | $ | (1.41 | ) | $ | (1.85 | ) | ||||||
Weighted-Average Common Shares Outstanding, Basic and Diluted | 72,794 | 62,130 | 65,242 | 55,268 | ||||||||||||||
* Includes stock-based compensation as follows | ||||||||||||||||||
Research and development | $ | 934 | $ | 1,449 | $ | 5,270 | $ | 3,267 | ||||||||||
General and administrative | 1,826 | 1,674 | 6,698 | 15,637 | ||||||||||||||
$ | 2,760 | $ | 3,123 | $ | 11,968 | $ | 18,904 | |||||||||||
Iovance Biotherapeutics, Inc. (1) | ||||||||||||||||||
Reconciliation of Selected GAAP Measures to Non-GAAP | ||||||||||||||||||
(unaudited; in thousands, except per share data) | ||||||||||||||||||
Three Months Ended December 31, |
Year Ended December 31, |
|||||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||||
Reconciliation of GAAP to non-GAAP Research and development | ||||||||||||||||||
GAAP Research and development | $ | 20,696 | $ | 10,119 | $ | 71,615 | $ | 26,941 | ||||||||||
Less: | ||||||||||||||||||
Non-cash stock-based compensation (2) | (934 | ) | (1,449 | ) | (5,270 | ) | (3,267 | ) | ||||||||||
Non-GAAP Research and development | $ | 19,762 | $ | 8,670 | $ | 66,345 | $ | 23,674 | ||||||||||
Reconciliation of GAAP to non-GAAP General and administrative | ||||||||||||||||||
GAAP General and administrative | $ | 5,375 | $ | 5,804 | $ | 21,262 | $ | 26,698 | ||||||||||
Less: | ||||||||||||||||||
Non-cash stock-based compensation (2) | (1,826 | ) | (1,674 | ) | (6,698 | ) | (15,637 | ) | ||||||||||
Non-GAAP General and administrative | $ | 3,549 | $ | 4,130 | $ | 14,564 | $ | 11,061 | ||||||||||
Non-GAAP Net loss attributable to common stockholders reconciliation | ||||||||||||||||||
GAAP Net loss attributable to common stockholders | $ | (25,854 | ) | $ | (15,689 | ) | $ | (92,064 | ) | $ | (102,348 | ) | ||||||
Add back: | ||||||||||||||||||
Non-cash stock-based compensation (2) | 2,760 | 3,123 | 11,968 | 18,904 | ||||||||||||||
Non-cash Deemed dividend related to beneficial conversion feature of convertible preferred stock (3) | - | - | - | 49,454 | ||||||||||||||
Non-GAAP Net loss attributable to common stockholders | $ | (23,094 | ) | $ | (12,566 | ) | $ | (80,096 | ) | $ | (33,990 | ) | ||||||
Three Months Ended December 31, |
For the Year Ended December 31, |
|||||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||||
Non-GAAP net loss per share reconciliation | ||||||||||||||||||
GAAP net loss per common share, basic and diluted: | $ | (0.36 | ) | $ | (0.25 | ) | $ | (1.41 | ) | $ | (1.85 | ) | ||||||
Add back: | ||||||||||||||||||
Non-cash stock-based compensation (2) | 0.04 | 0.05 | 0.18 | 0.34 | ||||||||||||||
Non-cash Deemed dividend related to beneficial conversion feature of convertible preferred stock (3) | - | - | - | 0.89 | ||||||||||||||
Non-GAAP net loss per common share, basic and diluted | $ | (0.32 | ) | $ | (0.20 | ) | $ | (1.23 | ) | $ | (0.62 | ) | ||||||
Weighted-Average Common Shares Outstanding, Basic and Diluted | 72,794 | 62,130 | 65,242 | 55,268 | ||||||||||||||
(1) 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.
(2) All stock-based compensation was excluded for the non-GAAP analysis.
(3) The deemed dividend related to the conversion feature of the Series B Preferred Stock was excluded for non-GAAP analysis.