UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): August 6, 2018
IOVANCE
BIOTHERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Charter)
| Delaware | ||
| (State of Incorporation) | ||
| 001-36860 | 75-3254381 | |
| Commission File Number | (I.R.S. Employer Identification No.) | |
| 999 Skyway Road, Suite 150 | ||
| San Carlos, California | 94070 | |
| (Address of Principal Executive Offices) | (Zip Code) | |
| (650) 260-7120 | ||
| (Registrant’s Telephone Number, Including Area Code) | ||
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425). |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12). |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)). |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)). |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 2.02. | Results of Operations and Financial Condition. |
On August 6, 2018, the Company issued a press release announcing its financial results for the second quarter ended June 30, 2018 and an update on recent developments. A copy of that press release is furnished as Exhibit 99.1.
The information furnished under this Item 2.02, including the accompanying Exhibit 99.1, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall such information be deemed to be incorporated by reference in any subsequent filing by the Company under the Securities Act of 1933 or the Exchange Act, regardless of the general incorporation language of such filing, except as specifically stated in such filing.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press Release of Iovance Biotherapeutics, Inc., dated August 6, 2018. |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: August 6, 2018 | IOVANCE BIOTHERAPEUTICS, INC. | |
| By: | /s/ MARIA FARDIS | |
| Maria Fardis, Chief Executive Officer | ||
Exhibit 99.1
Iovance Biotherapeutics Reports Second Quarter 2018 Financial Results and Provides Corporate Update
- Company to Host Conference Call at 4:30pm ET Today -
SAN CARLOS, CA – August 6, 2018 -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, today reported its second quarter and six months ended June 30, 2018 financial results and provided a corporate update.
“The dosing of the first patient with lifileucel in Europe for the treatment of metastatic melanoma marked an important milestone for Iovance and our global development plans as we continue our mission to develop TIL therapy as a treatment option for cancer patients. In line with expansion of the TIL platform, we are initiating investigation of TIL therapy in several new indications with high unmet need, as part of our collaboration with MD Anderson,” said Dr. Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. “We continue to advance our four company-sponsored trials and intend to provide an update regarding our melanoma program later this year.”
Recent Achievements
Manufacturing
| · | Initiated manufacturing at Lonza, Netherlands in support of the melanoma and cervical clinical sites in Europe. |
Clinical
| · | Enrollment in the global Phase 2 metastatic melanoma study, C-144-01, continues and in June 2018, the company announced that it dosed the first patient with LN-144 (lifileucel) in Europe at a clinical trial site in the United Kingdom. |
| · | As part of a collaboration program, Iovance and MD Anderson Cancer Center (MDACC) initiated two new Phase 2 clinical studies. The first, 2017-0672 (NCT03449108), is studying LN-145 manufactured by Iovance using the company’s Gen 2 manufacturing process to treat patients with soft tissue sarcoma, osteosarcoma and platinum resistant ovarian cancer. The study is active and enrolling patients. The second study is expected to be activated before the end of 2018 and will use TIL manufactured by MDACC. |
| · | Iovance has expanded to over 70 clinical sites for its four company-sponsored studies. |
Regulatory
| · | As of the end of July 2018, Iovance has activated sites for its two clinical trials being conducted in Europe in five countries including the Netherlands, France, Hungary, Spain and 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. |
Research
| · | Iovance entered into a Research Collaboration Agreement with Roswell Park Cancer Institute for a pre-clinical collaboration to explore the potential for TIL therapy in bladder and other cancers. |
Second Quarter 2018 Financial Results
Net loss for the second quarter ended June 30, 2018 was $30.7 million, or $0.34 per share, compared to net loss of $23.4 million, or $0.37 per share for the same period ended June 30, 2017.
Research and development expenses were $24.6 million for the second quarter ended June 30, 2018, an increase of $6.0 million compared to $18.6 million for the second quarter ended June 30, 2017. The increase in research and development expenses was primarily attributable to a $2.8 million increase in payroll and related expenses, including stock-based compensation expenses, due to a higher number of full time employees and dedicated consultants as we expanded our research efforts and clinical development programs. In addition, a $4.5 million increase occurred due to clinical trial costs because of higher patient enrollment and the number of clinical sites in the clinical trial of lifileucel, for the treatment of metastatic melanoma, and the ongoing clinical trials of LN-145 for the treatment of cervical, head and neck and lung cancers. These increases were partially offset by a $1.0 million decrease in manufacturing costs due to higher costs in 2017 related to technical transfer activities.
General and administrative expenses were $6.8 million for the quarter ended June 30, 2018, an increase of $1.9 million compared to $4.9 million for the second quarter ended June 30, 2017. The increase was primarily attributable to a $1.6 million increase in payroll and related expenses, including stock-based compensation expenses, due to an increase in head count and higher stock prices during the quarter, and a $0.3 million increase in professional service and legal expenses.
Six Months Ended June 30, 2018 Financial Results
Net loss for the six months ended June 30, 2018 was $ 57.2 million, or $0.65 per share, compared to net loss of $44.1 million, or $0.71 per share for the same period ended June 30, 2017.
Research and development expenses were $44.5 million for the six months ended June 30, 2018, an increase of $10.3 million compared to $34.2 million for the same period ended June 30, 2017. The increase in research and development expenses was primarily attributable to a $5.7 million increase in payroll and related expenses, including stock-based compensation expenses, primarily due to a higher number of full time employees and higher stock prices in 2018, and additional outside services contracted to perform research and development activities on our behalf, and a $7.0 million increase in costs related to our clinical trials as we expanded our clinical development programs into additional indications and added clinical trial sites in Europe. These increases were partially offset by a $2.0 million decrease in manufacturing costs due to higher costs in 2017 related to technical transfer activities.
General and administrative expenses were $13.8 million for the six months ended June 30, 2018, an increase of $3.6 million compared to $10.2 million for the same period ended June 30, 2017. The increase was primarily attributable to a $2.7 million increase in payroll and related expenses, including stock-based compensation expenses, due to a higher number of full time employees and higher stock prices in 2018, and a $0.5 million increase in legal expenses.
At June 30, 2018, the company held $276.1 million in cash, cash equivalents, and short-term investments compared to $297.1 million at March 31, 2018. During the second quarter the company used $24.0 million for operating activities. The company anticipates that the year-end balance of cash, cash equivalents and short-term investments may be between $190 to $210 million.
Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m. ET to discuss these second quarter and six months ended June 30, 2018 results and provide a corporate update. The conference call dial-in numbers are: 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID for the call is 5177499. The live webcast can be accessed under “News & Events” in the “Investors” section of the company’s website at http://www.iovance.com/ or you may use the link: https://edge.media-server.com/m6/p/xqrxbkif.
A replay of the call will be available from August 6, 2018 at 7:30 p.m. ET to August 13, 2018 at 8:30 p.m. ET. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The reference access code is 5177499. The archived webcast will be available for thirty days in the Investors section of Iovance Biotherapeutics’ website at http://www.iovance.com.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. is a clinical-stage biotechnology company focused on the development of cancer immunotherapy products for the treatment of various cancers. The Company's lead product candidate is an adoptive cell therapy using TIL technology being investigated for the treatment of patients with metastatic melanoma, recurrent and/or metastatic squamous cell carcinoma of the head and neck, recurrent, metastatic or persistent cervical cancer and locally advanced or metastatic non-small cell lung cancer. For more information, please visit http://www.iovance.com.
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 clinical trials in Europe and the U.S. are examples of such forward-looking statements. The forward-looking statements include, but are not limited to, risks and uncertainties relating to the success, initiation, timing, projected enrollment, progression through stages in trial design, completion, manufacturing capabilities, and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates (including both Company-sponsored and collaborator-sponsored trials); the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; the strength of Company’s product pipeline; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s manufacturing, license or development agreements; the acceptance by the market of the Company’s product candidates, if approved; the Company’s cash guidance; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. A further list and description of the Company’s risks, uncertainties and other factors can be found in the Company’s most recent Annual Report on Form 10-K and the Company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or www.iovance.com. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
###
Investor Relations Contact:
Sarah McCabe
Stern Investor Relations, Inc.
212-362-1200
sarah@sternir.com
Media Relations Contact:
John Capodanno
FTI Consulting
212-850-5705
john.capodanno@fticonsulting.com
IOVANCE BIOTECHNOLOGIES, INC.
Selected Consolidated Balance Sheet Data
(Unaudited, in thousands)
| June 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Cash and cash equivalents | $ | 246,017 | $ | 145,373 | ||||
| Short-term investments | $ | 30,082 | $ | - | ||||
| Total assets | $ | 284,751 | $ | 155,373 | ||||
| Stockholders' equity | $ | 270,569 | $ | 145,481 | ||||
IOVANCE BIOTECHNOLOGIES, INC.
Condensed Statements of Operations
(unaudited, in thousands, except per share information)
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
| Costs and expenses* | ||||||||||||||||
| Research and development | 24,551 | 18,647 | 44,463 | 34,240 | ||||||||||||
| General and administrative | 6,827 | 4,934 | 13,792 | 10,224 | ||||||||||||
| Total costs and expenses | 31,378 | 23,581 | 58,255 | 44,464 | ||||||||||||
| Loss from operations | (31,378 | ) | (23,581 | ) | (58,255 | ) | (44,464 | ) | ||||||||
| Other income | ||||||||||||||||
| Interest income, net | 718 | 204 | 1,080 | 403 | ||||||||||||
| Net Loss | $ | (30,660 | ) | $ | (23,377 | ) | $ | (57,175 | ) | $ | (44,061 | ) | ||||
| Net Loss Per Common Share, Basic and Diluted | $ | (0.34 | ) | $ | (0.37 | ) | $ | (0.65 | ) | $ | (0.71 | ) | ||||
| Weighted-Average Common Shares Outstanding, Basic and Diluted | 90,236 | 62,457 | 87,310 | 62,371 | ||||||||||||
| * Includes stock-based compensation as follows | ||||||||||||||||
| Research and development | $ | 2,381 | $ | 1,742 | $ | 4,381 | $ | 2,992 | ||||||||
| General and administrative | 2,841 | 1,551 | 4,945 | 3,597 | ||||||||||||
| $ | 5,222 | $ | 3,293 | $ | 9,326 | $ | 6,589 | |||||||||
| (1) | Certain amounts within the statement of operations for the three and six months ended June 30, 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. |