Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) is focused on the development and commercialization of autologous cellular immunotherapies optimizing personalized, tumor-directed Tumor Infiltrating Lymphocytes (TIL). The company is conducting three Phase 2 clinical trials to assess the efficacy and safety of autologous Tumor Infiltrating Lymphocytes for treatment of patients with Metastatic Melanoma, Squamous Cell Carcinoma of the Head and Neck and Cervical Cancer.
The company released its quarterly earnings results on October 31st. GAAP net loss attributable to common stockholders for the quarter ended September 30, 2017, was $22.1 million, or ($0.35) per share, compared to GAAP net loss of $68.2 million or ($1.15) per share for 2016.
In the third quarter of 2017, IOVA 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 FDA granting Fast Track designation for LN-144 for the treatment of advanced melanoma and approval of a CTA by the competent authority in the Netherlands for the Phase 2 trial of LN-145 in cervical carcinoma.
On the corporate front, the company successfully completed a common stock offering adding approximately $54.0 million in net proceeds to the cash reserves. In the fourth quarter of 2017, the company looks forward to sharing new clinical data from Cohort 2 of the C-144-01 metastatic melanoma trial and nonclinical data at the upcoming SITC meeting from November 8-12, 2017 in National Harbor, Maryland.
IOVA is one of those biotech plays which has multiple shots under its pipeline, strong clinical partnerships, good analyst support, and potential lucrative focus areas. In fact, the company also completed a capital raise recently which is a comfort for its liquidity and overall financial flexibility.
Markets are now looking to the potential upside catalyst for the company and, if the news hits press favorably, the stock of the company will be on a rapid growth trajectory. Even if it misses, the subsequent dip in share price will serve as an option to make a position for the eventual upside run. Several equities research analysts recently issued favorable reports on IOVA. The stock currently has an average rating of “Buy” and an average price target of $14.53
About the company: IOVANCE Biotherapeutics is focused on the development and commercialization of autologous cellular immunotherapies optimizing personalized, tumor-directed Tumor Infiltrating Lymphocytes (TIL)
- C-144-01 is a multicenter clinical trial now recruiting patients with Metastatic Melanoma at various sites in the US.
- C-145-03 is a multicenter clinical trial now recruiting patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) at various sites in the US.
- C-145-04 is a multicenter clinical trial now recruiting patients with Cervical Carcinoma at various sites in the US.
Iovance Biotherapeutics Pipeline: The company’s pipeline is relatively exhaustive, with multiple ongoing trials in melanoma, cervical, and head and neck cancers, along with planned studies in various other settings.
The market opportunity for TIL Therapy in the USA: Iovance’s lead indication for TIL is metastatic melanoma:
- Prevalence of melanoma in US (2014) is greater than 1.17 million cases
- 74% percent of new cases each year occur in patients 20-74 years old
- Metastatic (regional and distant) melanoma patients compose 13% of all new cases ~10,000 cases
The competitive advantage of TILs in Solid Tumors: TILs target a diverse array of cancer antigens; this approach represents a highly differentiated, customized, and targeted immunotherapy.
Other Recent Highlights:
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.
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.
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.
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. After the end of the quarter, the Company received CTA approvals in Hungary for metastatic melanoma and the United Kingdom for cervical carcinoma and metastatic melanoma.
Research Collaboration Agreement with Ohio State University: In September, the Company entered into a collaboration with the Ohio 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 2017 Congress in September with data that demonstrates the ability to produce TIL from lymphoma that has similar functionality as TIL generated from melanoma.
2nd Quarter 2017 Financial Results:
GAAP net loss attributable to common stockholders for the quarter ended September 30, 2017, was $22.1 million, or ($0.35) per share, compared to GAAP net loss of $68.2 million or ($1.15) per share for the quarter ended September 30, 2016.
As of September 30, 2017, the Company held $163.4 million in cash and cash equivalents and short-term investments, compared to $166.5 million as of December 31, 2016.
Key risk factors and potential stock drivers:
The company is optimistic about the positive outcome of the upcoming SITC meeting. This meeting will be a critical catalyst for the company going forward.
The outcome of the upcoming milestones/catalysts could be the near-term trigger for the company. Any non-favorable developments could impinge the business and financial risk profile of the company.
Biotech space in itself is a high-risk sector due to uncertainties associated with the novel drug development. The company may experience financial, regulatory, or operational difficulties, which may impair its ability to commercialize their drug products.
On Monday, November 6, 2017, IOVA is at $7.90 on volume of 396K shares exchanging hands. Market capitalization is $566.54 million. The current RSI is 58.72
In the past 52 weeks, shares of IOVA have traded as low as $4.45 and as high as 8.60
At $7.90, shares of IOVA are trading above its 50-day moving average (MA) at $7.27 and above its 200-day MA at $6.73 as well.
The present support and resistance levels for the stock are at $7.00 & $8.05 respectively.
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