"In the third quarter of 2017 we continued to make significant progress in the clinic as the first patient was dosed with LN-145 in the Phase 2 trial for cervical cancer. Regulatory progress was demonstrated with the
Third Quarter 2017 and Recent Highlights and Anticipated Milestones
- Appointed New Chief Financial Officer (CFO): In August,
Tim Morris was appointed CFO of Iovance. Mr. Morris brings over 22 years of experience related to the biopharmaceutical industry.
- Completion of Public Offering: In September, the Company completed a public offering of 8,846,154 shares of its common stock at a price of $6.50 per share, before underwriting discounts. The shares of common stock issued and sold in the offering at the closing include 1,153,846 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares. The net proceeds from the offering, after deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance, are approximately $54.0 million.
Clinical Trial Progress:
- C-144-01 Phase 2 Trial in Metastatic Melanoma: In October, preliminary data from Cohort 2 of the ongoing C-144-01 Phase 2 trial of LN-144 was accepted as a late-breaking abstract to be presented at the
Society for Immunotherapy of Cancer (SITC ) 2017 Annual Meeting.
- First Patient Dosed in C-145-04 Phase 2 Trial in Cervical Cancer: In August, the first patient was dosed in the C-145-04 Phase 2 trial of LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma.
Manufacturing Updates:
- Partnership with TrakCel for Personalized Patient Product Management: In September, Iovance commenced a partnership with
TrakCel Ltd. to build a scheduling and logistics tool that automates the supply chain for Iovance's adoptive cell therapy products that utilize its TIL technology. The TrakCel Solution will electronically link Iovance with clinical sites, contract manufacturing organizations and couriers to schedule and track TIL therapies for each patient. The TrakCel Solution is intended to help manage capacity utilization and throughput as well as providing efficiencies in the delivery of TIL treatment.
Regulatory Updates:
- Fast Track Designation Granted for LN-144: In August, the
U.S. Food and Drug Administration (FDA ) granted Fast Track designation for LN-144, the Company's adoptive cell therapy using its TIL technology, for the treatment of advanced melanoma. - European Clinical Trial Applications (CTAs): Iovance initiated the submission of CTAs in multiple countries in Europe starting in August 2017 in support of Phase 2 clinical trials of LN-145 in cervical carcinoma and LN-144 in metastatic melanoma. In September, the Company received the first approval from the competent authority in the
Netherlands , for LN-145 for the treatment of patients with cervical carcinoma. Subsequent to the end of the quarter, the Company received CTA approvals inHungary for metastatic melanoma and theUnited Kingdom for cervical carcinoma and metastatic melanoma.
Research Update and Data Presentations:
- Research Collaboration Agreement with
Ohio State University : In September, the Company entered into a collaboration with theOhio State University . The collaboration will initially focus on hematologic malignancies in areas of poor prognostic cancers with high unmet medical need, which include acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL). - Poster Presentation at
European Society for Medical Oncology (ESMO): In August, the Company announced a poster presentation at the ESMO 2017Congress in September with data that demonstrates the ability to produce TIL from lymphoma that have similar functionality as TIL generated from melanoma.
Third Quarter 2017 Financial and Operating Results
As of
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 nine 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 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.
2017 Year End Guidance for Cash, Cash Equivalents and Short-Term Investments
Iovance anticipates the cash, cash equivalents and short-term investments as of
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 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 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) |
|||||||
| September 30, | December 31, | ||||||
| 2017 | 2016 | ||||||
| Cash, cash equivalents and short-term investments | $ | 163,380 | $ | 166,470 | |||
| Total assets | $ | 173,970 | $ | 171,886 | |||
| Stockholders' equity | $ | 165,441 | $ | 166,918 | |||
| Condensed Consolidated Statements of Operations (unaudited; in thousands, except per share data) |
|||||||||||||||
| For the Three Months Ended September 30, |
For the Nine Months Ended September 30, |
||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | |||||||
| Costs and expenses* | |||||||||||||||
| Research and development | 17,753 | 8,481 | 54,029 | 17,200 | |||||||||||
| General and administrative | 4,590 | 10,498 | 12,777 | 20,517 | |||||||||||
| Total costs and expenses | 22,343 | 18,979 | 66,806 | 37,717 | |||||||||||
| Loss from operations | (22,343 | ) | (18,979 | ) | (66,806 | ) | (37,717 | ) | |||||||
| Other income | |||||||||||||||
| Interest income | 194 | 221 | 596 | 511 | |||||||||||
| Net Loss | $ | (22,149 | ) | $ | (18,758 | ) | $ | (66,210 | ) | $ | (37,206 | ) | |||
| Deemed dividend related to beneficial conversion feature of convertible preferred stock | - | (49,454 | ) | - | (49,454 | ) | |||||||||
| Net Loss Attributable to Common Stockholders | (22,149 | ) | (68,212 | ) | (66,210 | ) | (86,660 | ) | |||||||
| Net Loss Per Common Share, Basic and Diluted | $ | (0.35 | ) | $ | (1.15 | ) | $ | (1.06 | ) | $ | (1.64 | ) | |||
| Weighted-Average Common Shares Outstanding, Basic and Diluted |
63,332 | 59,113 | 62,697 | 52,963 | |||||||||||
| * Includes stock-based compensation as follows | |||||||||||||||
| Research and development | $ | 1,053 | $ | 640 | $ | 4,336 | $ | 1,818 | |||||||
| General and administrative | 1,566 | 8,005 | 4,872 | 13,963 | |||||||||||
| $ | 2,619 | $ | 8,645 | $ | 9,208 | $ | 15,781 | ||||||||
| Iovance Biotherapeutics, Inc. (1) Reconciliation of Selected GAAP Measures to Non-GAAP (unaudited; in thousands, except per share data) |
|||||||||||||||
| For the Three Months Ended September 30, |
For the Nine Months Ended September 30, |
||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||
| Reconciliation of GAAP to non-GAAP Research and development | |||||||||||||||
| GAAP Research and development | $ | 17,753 | $ | 8,481 | $ | 54,029 | $ | 17,200 | |||||||
| Less: | |||||||||||||||
| Non-cash stock-based compensation (2) | (1,053 | ) | (640 | ) | (4,336 | ) | (1,818 | ) | |||||||
| Non-GAAP Research and development | $ | 16,700 | $ | 7,841 | $ | 49,693 | $ | 15,382 | |||||||
| Reconciliation of GAAP to non-GAAP General and administrative | |||||||||||||||
| GAAP General and administrative | $ | 4,590 | $ | 10,498 | $ | 12,777 | $ | 20,517 | |||||||
| Less: | |||||||||||||||
| Non-cash stock-based compensation (2) | (1,566 | ) | (8,005 | ) | (4,872 | ) | (13,963 | ) | |||||||
| Non-GAAP General and administrative | $ | 3,024 | $ | 2,493 | $ | 7,905 | $ | 6,554 | |||||||
| Non-GAAP Net loss reconciliation | |||||||||||||||
| GAAP Net loss | $ | (22,149 | ) | $ | (68,212 | ) | $ | (66,210 | ) | $ | (86,660 | ) | |||
| Add back: | |||||||||||||||
| Non-cash stock-based compensation (2) | 2,619 | 8,645 | 9,208 | 15,781 | |||||||||||
| Non-cash Deemed dividend related to beneficial conversion feature of convertible preferred stock (3) | - | 49,454 | - | 49,454 | |||||||||||
| Non-GAAP Net loss | $ | (19,530 | ) | $ | (10,113 | ) | $ | (57,002 | ) | $ | (21,425 | ) | |||
| For the Three Months Ended September 30, |
For the Nine Months Ended September 30, |
||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||
| Non-GAAP net loss per share reconciliation | |||||||||||||||
| GAAP net loss per basic and diluted share: | $ | (0.35 | ) | $ | (1.15 | ) | $ | (1.06 | ) | $ | (1.64 | ) | |||
| Add back: | |||||||||||||||
| Non-cash stock-based compensation (2) | 0.04 | 0.15 | 0.15 | 0.30 | |||||||||||
| Non-cash Deemed dividend related to beneficial conversion feature of convertible preferred stock (3) | - | 0.83 | - | 0.94 | |||||||||||
| Non-GAAP net loss per basic and diluted share | $ | (0.31 | ) | $ | (0.17 | ) | $ | (0.91 | ) | $ | (0.40 | ) | |||
| Weighted-Average Common Shares Outstanding, Basic and Diluted |
63,332 | 59,113 | 62,697 | 52,963 | |||||||||||
- 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.
- The deemed dividend related to the conversion feature of the Series B Preferred Stock was excluded for non-GAAP analysis.