On October 15, 2018 Enzo Biochem Inc. (NYSE:ENZ), an integrated diagnostic and therapeutics company, reported results for the fourth quarter and fiscal year ended July 31, 2018, in addition to announcing New York State department of Health’s approval of additional assays for new women’s health infectious disease panel continuing to drive focus in development of lower cost products, platforms and services for the clinical laboratory market (Press release, Enzo Biochem, OCT 15, 2018, View Source [SID1234529918]).

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Recent Developments

Progress in molecular amplification and immunohistochemistry platforms is leading to full system solution to aid in addressing challenge of maintaining profitability for clinical labs in a market affected by declining reimbursement and high operating costs.
New York State Department of Health has approved an additional three women’s health infectious disease diagnostic assays to expand Enzo’s women’s health panel to 16 pathogens on the Company’s proprietary, versatile and cost effective AMPIPROBE platform. This addition makes the panel one of the most comprehensive in the $800 million market. This is performed using a single swab and now includes Ureaplasma spp./M. genitalium/M. hominis (UMM) in addition to Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis Candida spp (C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis), Atopobium vaginae, Gardnerella vaginalis, Lactobacillus spp, Megasphera spp and BVAB2. UMM testing is vital to women’s health as mycoplasmas are a significant cause of non-gonococcal urethritis. Ureaplasmas are also associated with urethritis, and a myriad of additional medical conditions.
Entered into an agreement to purchase an additional commercial facility with nearly 36,000 square feet in Farmingdale, NY. The building adjacent to the Company’s current Long Island campus enhances the infrastructure needed to produce and distribute Enzo’s expanding low cost, open architecture diagnostic platform products and broaden related services. The Company’s platform development includes automation-compatible reagent systems and associated products for sample collection and processing through to analysis.
Continued product and platform development activities directed to each step of the clinical testing process, expanding into sample collection and processing. The Company’s programs include manufacturing all components required for each step in the diagnostic process for integration into an open platform. Enzo’s system solutions will enable clinical laboratories to gain economic return in the diagnostics market where declining reimbursements and rigid costs from suppliers currently prevail.
Building on prior progress in the molecular diagnostics and immunohistochemistry areas, Enzo also recently announced the validation of three clinically relevant, cost-efficient immunohistochemistry (IHC) biomarker detection tests for charting the progression of various cancers, especially in the field of women’s health. These tests operate with the Company’s open system workflow and complement Enzo’s strategy of introducing lower cost testing solutions to the global IHC market that is projected to reach over $2 billion by 2021.
The Company recently designated an in-network laboratory provider for three new health insurance providers in the MidAtlantic and New England areas to support geographical expansion. These additional contracts are expected to add to Enzo’s national reach of testing services to millions of covered lives across the U.S.
New York Federal case against Hoffman LaRoche proceeding with trial date set for early April 2019.
The Company expects the commercialization from the developments of its strategic initiatives will begin over the next year at which time it anticipates returning to revenue and margin growth. The significant implementation steps include:

Validation through clinical trials of Enzo’s fully automated, high-throughput instrumentation including sample collection and sample processing and reagents systems both for New York State and FDA.
Completion of buildout of GMP manufacturing capabilities.
Approval of additional assays to expand Enzo’s test menu.
Expansion of sales and marketing, logistics and IT efforts to grow national reference laboratory accounts.
Partnerships and collaborations with potential strategic and institutional partners to enhance commercialization and market penetration of Enzo’s high technology platforms and products.
Barry Weiner, Enzo President, Comments:

"Fiscal 2018 was a year of solid progress in our strategic plan, and one in which each of the principal operating units posted volume increases and achieved objectives towards our growth initiatives. These initiatives began over three years ago now provide the potential for multiple ventures and partnerships that could generate significant shareholder value. Our focus is centered on providing cost efficient products and services utilizing our proprietary assays optimized for our automated, open system platforms that are compatible with existing sample collection devices as well as our own lower cost option. These have been designed to provide not only high-performance and adaptable solutions to existing lab workflow, but also to address a critical need for lower cost solutions. Besides the number of assays already approved, in process is the development of a screening assay for oncogenic forms of HPV, among others. Today’s clinical laboratories including Enzo face a two-fold challenge – to maintain revenue growth and profitability, amidst declining reimbursements and unreasonably high operating costs. The latter stem from "closed system" diagnostics platforms, sample collection devices and accessories that are a barrier to the use of low-cost and efficient third-party solutions.

Our efforts were not limited to laboratory product development, but also included building an internal sales force that will enable us to grow this business. We also have added to our development staff, and hired experienced professionals especially knowledgeable about health care providers in order to bring them into our fold as clients. In the next few quarters, our strategic plans call for a number of new tests currently under development to be submitted for New York State Department of Health for conditional approval to add to those already authorized, which will further expand our already sizable test menu. Our Women’s Health Panel was expanded with three more tests this quarter to 16 analytes that can be processed in one sample.

Our acquisition of a new facility ties in directly with the anticipated expansion of our capabilities at the Farmingdale, NY campus. In addition to enhancing efficiency, the purchase represents an important vote of confidence in our strategic plan. The new facility will provide Good Manufacturing Practices (GMP) and ISO compliant manufacturing and logistics space for Enzo’s diagnostics and life science products business. Moreover, the new facility will enhance space for GMP production of the Company’s development-stage clinical candidates, including Enzo’s proprietary sphingosine kinase 1 inhibitor, SK1-I, which is being investigated for potential applications in oncology and autoimmune diseases. This effort opens potential for strategic partnerships. It is a time-consuming, capital intensive effort, to transform an entity into a provider of platform, products and services in a relatively short time. We believe when the transition is completed over the next year that the Company will look very different than it does today, with an anticipated return to revenue and margin growth."

Fiscal 2018 Operating Results

Total revenues were $104.7 million, compared to $107.8 million in the prior year, a decrease of $3.1 million, or 3%. Clinical services revenues were $74.8 million, compared to $77.4 million in the prior year, a decrease of $2.6 million or 3% due to lower insurance reimbursement payments and shifts in test mix to lower esoteric testing verses high genetic testing in the prior year. Total diagnostic testing volume, measured by the number of accessions reported, increased 4% year over year. Clinical products and royalties revenue was $29.9 million compared to $30.4 million in the prior year. The decline year over year resulted from lower product royalties from an agreement that expired in April 2018.
Consolidated gross margins were 42% compared with 45% in the prior year. Clinical services gross margins were 39% compared to 41% a year ago. Gross margins in the current year were negatively impacted by lower revenue from Clinical Services as noted above. Clinical products and royalties gross margin was 52% compared to 54% in the prior year period.
Operating expenses totaled $56.5 million, up 10% compared to $51.4 million a year ago. The increase reflected legal fee expenses in anticipation of a patent infringement and contract related trial, where Enzo is plaintiff that may occur next calendar year. Total legal expenses were $5.1 million compared to $1.7 million in the prior year. Selling and general administrative expenses (SG&A) as well as research and development (R&D) expenses were slightly higher year over year in support of the Company’s growth strategies. As a percentage of revenue, SG&A was 42% compared to 41% in the prior year and R&D expenses were flat year over year.
The GAAP and Non-GAAP net loss was $10.3 million and $11.4 million, respectively, compared to $2.5 million a year ago. The GAAP net loss per share was $0.22, compared to $0.05 a year ago, and the Non-GAAP loss per share was $0.24. There were no Non-GAAP adjustments in the prior year. EBITDA was a loss of $9.1 million compared to earnings of $0.7 million a year ago.
Fourth Quarter Operating Results

Total revenues were $24.5 million, compared to $28.2 million in the prior year, a decrease of $3.7 million. Clinical services revenues were $16.8 million, compared to $20.4 million in the prior year, a decrease of $3.7 million. Approximately $1.7 million of the current quarter’s revenue decline relates to a previously reported account loss with the remaining decline due to lower insurance reimbursement payments and shifts in test mix away from high valued genetic testing in the prior year. Total diagnostic testing volume, measured by the number of accessions reported, decreased 3% year over year, however it increased 3% sequentially compared to the third fiscal quarter of 2018. Clinical products and royalties revenue was approximately $7.7 million in both the current year and prior year periods.
Consolidated gross margins were 40% compared with 44% in the prior year. Clinical services gross margins were 33% compared to 41% a year ago. Gross margins in the current year were negatively impacted by lower revenue from Clinical Services as noted above. Clinical products and royalties gross margins increased 120 basis points year over year to 54%.
Operating expenses totaled $15.4 million, up 19% compared to $12.9 million from a year ago. The increase reflected higher legal fee expenses of $0.9 million in anticipation of the aforementioned patent infringement and contract related trial, increased allowances for bad debts of $0.9 million and higher SG&A expenses of $0.6 million. R&D expenses were flat year over year.
The GAAP and Non-GAAP net loss was $5.8 million compared to breakeven a year ago. The GAAP and Non-GAAP net loss per share was $0.12 and compared to $0.05 a year ago. There were no Non-GAAP adjustments in the current and prior year. EBITDA was a loss of $5.3 million compared to EBITDA earnings of $0.9 million a year ago.
Total cash and cash equivalents at July 31, 2018 were $60.0 million compared to $64.2 million at July 31, 2017. Cash used in operations was $2.7 million during fiscal 2018 and cash used for investing activities, principally capital expenditures, was $1.9 million. Operating segments continue to be cash flow positive. Working capital at July 31, 2018 was over $63.0 million.

Conference Call

The Company will conduct a conference call Tuesday, October 16, 2018 at 8:30 AM ET. The call can be accessed by dialing 1-888-459-5609. International callers can dial 1-973-321-1024. Please reference PIN number 6096026.

Interested parties may also listen over the Internet at: View Source

To listen to the live call, individuals should go to the website at least 15 minutes early to register, download and install any necessary audio software. Any pop up blocker installed on your PC should be disabled while accessing the webcast. A rebroadcast of the call will be available starting approximately two hours after the conference call ends, through 12 AM (E.T.) Tuesday, October 30, 2018. The replay of the conference call can be accessed by dialing 1-855-859-2056 (International callers can dial 1-404-537-3406) and, when prompted, use the same PIN number 6096026.

Adjusted Financial Measures

To comply with Regulation G promulgated pursuant to the Sarbanes-Oxley Act, Enzo Biochem attached to this news release and will post to the Company’s investor relations web site (www.enzo.com) any reconciliation of differences between GAAP and Adjusted financial information that may be required in connection with issuing the Company’s quarterly financial results.

The Company uses EBITDA as a measure of performance to demonstrate earnings exclusive of interest, taxes, depreciation and amortization. Adjustments to EBITDA are for items of a non-recurring nature and are reconciled on the table provided. The Company manages its business based on its operating cash flows. The Company, in its daily management of its business affairs and analysis of its monthly, quarterly and annual performance, makes its decisions based on cash flows, not on the amortization of assets obtained through historical activities. The Company, in managing its current and future affairs, cannot affect the amortization of the intangible assets to any material degree, and therefore uses EBITDA as its primary management guide. Since an outside investor may base its evaluation of the Company’s performance based on the Company’s net loss not its cash flows, there is a limitation to the EBITDA measurement. EBITDA is not, and should not be considered, an alternative to net loss, loss from operations, or any other measure for determining operating performance of liquidity, as determined under accounting principles generally accepted in the United States (GAAP). The most directly comparable GAAP reference in the Company’s case is the removal of interest, taxes, depreciation and amortization.

We refer you to the tables attached to this press release which includes reconciliation tables of GAAP to Adjusted net income (loss) and EBITDA to Adjusted EBITDA.

On October 15, 2018 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported it has received a positive recommendation from the independent Data Monitoring Committee (DMC) to continue enrolling into the Company’s Phase 3 "Fluorescent Light Activated Synthetic Hypericin" (FLASH) study for SGX301 (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) (Press release, Soligenix, OCT 15, 2018, View Source [SID1234530279]). Following its unblinded interim analysis with data from approximately 100 subjects, including assessment of the study’s primary efficacy endpoint, the DMC recommended that approximately 40 additional subjects be randomized into the trial to maintain the rigorous assumption of 90% statistical power for the primary efficacy endpoint. No safety concerns were reported by the DMC based on the interim analysis.

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"We are pleased to have received the DMC’s recommendation to continue enrolling to the adjusted target of 160 evaluable subjects in order to maintain our conservative power calculation," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We have invested a significant amount of the Company’s resources over the last three years into the CTCL development program and it is gratifying to have received this feedback from the DMC indicating sufficient potential efficacy to warrant enrolling additional subjects into the trial. With this new level of clarity from the DMC’s analysis of the interim Phase 3 study data and given our current enrollment status of approximately 120 subjects, we anticipate completing the study before the end of 2019 with topline results coming no later than the first quarter of 2020. Given our current cash resources, we anticipate that the available funds are sufficient to cover the additional study patients needed. We believe SGX301 has the potential to be a valuable therapy in the treatment of early stage CTCL, which is an orphan disease and area of unmet medical need."

"The DMC’s recommendation is very encouraging and will allow us to aggressively pursue completing the trial, demonstrating SGX301’s potential to successfully treat the CTCL index lesions using a combination therapy (SGX301 and the proprietary fluorescent light panel) that minimizes the long-term risks of treatment-associated secondary cancers," stated Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix. "SGX301 truly has the potential to have a significant impact on the lives of CTCL patients. We would like to thank the DMC members for their assistance, as well as our esteemed medical advisory board and our dedicated clinical investigators for their ongoing efforts in the design and conduct of this important clinical trial."

Based on the positive results demonstrated in the Phase 2 study of SGX301, the pivotal Phase 3 protocol is a highly powered, double-blind, randomized, placebo-controlled, multicenter trial originally targeted to enroll 120 evaluable subjects. The trial consists of three treatment cycles, each of 8 weeks duration. Treatments are administered twice weekly for the first 6 weeks and treatment response is determined at the end of Week 8. In the first treatment cycle, approximately two-thirds of the subjects receive SGX301 (0.25% synthetic hypericin) and one-third of the subjects receive placebo treatment of their index lesions. In the second cycle, all subjects receive SGX301 treatment of their index lesions and in the optional third cycle all subjects receive SGX301 treatment of all their lesions. Subjects are followed for an additional 6 months after the completion of treatment. The primary efficacy endpoint is assessed on the percent of patients in each of the two treatment groups (i.e., SGX301 and placebo) achieving a successful response of the treated lesions, defined as an overall ≥50% reduction as assessed by the Composite Assessment of Index Lesion Severity (CAILS) scoring system across the three index lesions at the Cycle 1 evaluation visit (week 8) compared to the total CAILS score at baseline. Other secondary measures assessed are treatment response (including duration), degree of improvement, time to relapse and safety.

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as a rash and eventually forming raised plaques and tumors as the disease progresses. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 500,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 20,000 individuals in the US, with approximately 2,800 new cases seen annually.

About SGX301

SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p ≤ 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective: 58.3% compared to 8.3%, respectively. SGX301 has received orphan drug and fast track designations from the US Food and Drug Administration, as well as orphan designation from the European Medicines Agency.

The Phase 3 CTCL clinical study is partially funded with a National Cancer Institute Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.

On October 14, 2018 Innovent Biologics, Inc. (Innovent), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, reported that its IND application for a combination therapy of IBI308 (Sintilimab, an anti-PD-1 monoclonal antibody) and IBI305 (a biosimilar to the recombinant humanized anti-VEGF monoclonal antibody bevacizumab), has been approved by the National Medical Products Administration (NMPA, formerly known as CFDA) for clinical development (Press release, Innovent Biologics, OCT 14, 2018, View Source [SID1234529892]). Innovent will initiate clinical trials based on this combination to assess its safety and efficacy in patients with Non-Small Cell Lung Cancer (NSCLC) and hepatocellular carcinoma (HCC).

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"China has the highest burden of cancer patients of all countries in the world. Lung cancer and liver cancer account for about one third of all incident cases of cancers in China. At Innovent, an innovative biopharmaceutical company in China, we are dedicated to take advantage of the latest technological advances in science to develop and commercialize new medicines for cancer patients," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent, "Sintilimab’s New Drug Application (NDA) is currently under priority regulatory review and IBI305 has completed its phase 3 program. We believe the combination of IBI308 and IBI305 will provide more effective treatment for both lung cancer and liver cancer patients. We intend to capitalize on our company’s rich pipeline to explore new directions in combination therapy and to create even more innovative breakthroughs."

"Recent studies have shown there is a strong relationship between tumor induced angiogenesis driven by VEGFA and ANGPT2 and tumor induced immunosuppression driven by PD-1/PD-L1. Abnormal tumor-induced angiogenesis appears to limit the therapeutic effect of anti-PD-1/PD-L1 antibodies and other immunotherapy drugs. We believe the combination of sintilimab and bevacizumab biosimilar will be better able to control tumor growth through a two-pronged approach involving stimulation of the immune system with an anti-PD-1 antibody and blocking angiogenesis with an anti-VEGF antibody," said Dr. Kerry Blanchard, Chief Scientific Officer of Innovent.

About Non-Small Cell Lung Cancer

Lung cancer is the most common malignant tumor in China with the highest morbidity (781,000 new cases annually) and mortality (626,000 deaths annually). Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of all lung cancer cases. Seventy percent of NSCLC patients have non-squamous NSCLC and 40% of these patients harbor EGFR mutations. Treatment with a tyrosine kinase inhibitor (TKI: gefitinib, erlotinib or icotinib) is recommended for patients with advanced NSCLC who have EGFR mutations. After progression on TKI treatment, some patients acquire a T790M mutation and can be treated with osimertinib. In the absence of the T790M mutation or after treatment progression on osimertinib, the choice of systemic treatment is platinum-containing dual-agent chemotherapy. For such patients, new and more effective treatment options are urgently needed.

About Hepatocellular Carcinoma (HCC)

Liver cancer is the second leading cause of cancer-related death in China according to National Central Cancer Registry of China (NCCRC), with about 365,000 new cases and 319,000 deaths annually. Liver cancer with about 841,000 new cases and 782,000 deaths annually is the fourth leading cause of cancer-related death worldwide in 2018. Most primary liver cancers (70%-90%) are hepatocellular carcinoma (HCC) and most patients have locally advanced or metastatic disease at the time of diagnosis and are not eligible for radical treatment. With current therapy the global median survival time is only 7.9 months. However, for HCC patients in the Asia-Pacific region the median survival time is only 4.2 months. Hence, there is an urgent need for effective treatments for patients with advanced HCC in China and around the world.

About Sintilimab

Sintilimab is a fully human anti-PD-1 antibody. It binds to the PD-1 receptor on T cells, blocking the PD-L1 ligand from interacting with PD-1 to help restore T-cell response and immune response, thus destroying the tumor cells. Sintilimab is an anti-PD-1 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company in China. National Medical Products Administration (NMPA, formerly known as CFDA) accepted the New Drug Application (NDA) submitted by Innovent for sintilimab on April 16, 2018, and granted it priority review status on April 23, 2018. The indication for the first new drug application is relapsed/refractory classical Hodgkin’s Lymphoma.

About IBI305

IBI305, a biosimilar of bevacizumab, one of worldwide best-selling drugs, is currently in Phase III clinical trials. IBI305 specifically binds to vascular endothelial growth factors (VEGF), blocks the binding of VEGF to VEGF receptors and inhibits VEGF-induced angiogenesis and vascular permeability, thus limiting the growth of malignant tumors. Innovent has completed bioequivalence studies in healthy subjects and a randomized, double-blind, multicenter, phase III study in non-small cell lung cancer comparing IBI305 with Avastin.

About Combination Therapy

Combination strategies have become a key area of clinical research and may unlock the potential of immuno-oncology therapies by combining two anti-cancer agents that could have a synergistic mechanism of action. In IMpower150, a Phase III study, patients with non-squamous NSCLC and EGFR mutation who failed EGFR TKI treatment benefited from treatment with an anti-PD-L1 monoclonal antibody in combination with bevacizumab and chemotherapy . A Phase Ib trial (NCT02715531) of Atezolizumab combined with bevacizumab in the first-line treatment of advanced liver cancer showed that the combination was safe and effective with an objective response rate as high as 65%.

Sintilimab is a foundational agent for cancer therapies and Innovent will combine sintilimab with its rich development pipeline of innovative antibodies to form a diversity of tumor immunotherapies in our quest to provide affordable high quality biopharmaceuticals for even more patients.

On October 12, 2018 Nordic Nanovector ASA (OSE: NANO) reported that the Company and its collaborators will present data and analyses from its non-clinical and clinical studies with Betalutin (177Lu-lilotomab satetraxetan) at the 32nd Annual Congress of the European Association of Nuclear Medicine (13-17 October 2018, Düsseldorf, Germany) (Press release, Nordic Nanovector, OCT 12, 2018, View Source [SID1234553493]).

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The presentations are:

Therapeutic efficacy of 177Lu-lilotomab satetraxetan in non-Hodgkin B-cell Lymphoma is controlled by G2/M cell cycle progression

Authors: A. Pichard et al.

Session: 305 – M2M: Therapy Effects, Preclinical

Abstract No. OP-069

Format: Oral presentation

Date/time: Sunday 14 October, 11:30-12:45 CEST

Tumor Absorbed Dose and Changes in FDG PET Parameters in Non-Hodgkin Lymphoma Patients Treated with 177Lu-lilotomab satetraxetan

Authors: A. Løndalen et al.

Session: 608 – Clinical Oncology – Rapid Fire Session: It’s in the Blood!

Abstract No. OP-252

Format: Oral presentation

Date/time: Monday 15 October, 08:00-09:30 CEST

On October 12, 2018 Iovance Biotherapeutics, Inc. (Nasdaq:IOVA) ("Iovance" or "Company"), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported the pricing of an underwritten public offering of 22,000,000 shares of its common stock at a public offering price of $9.97 per share (Press release, Iovance Biotherapeutics, OCT 12, 2018, View Source;p=irol-newsArticle&ID=2371434 [SID1234529874]). The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance, are expected to be $219.3 million. In addition, Iovance has granted the underwriters a 30-day option to purchase up to 3,300,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about October 16, 2018, subject to customary closing conditions.

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Iovance intends to use the proceeds from this offering to fund the expansion of its organization to support the potential commercial launch of lifileucel, to fund its commercial manufacturing capabilities and facilities, to fund its ongoing clinical trials for its current product candidates, including its on-going Phase 2 clinical trials of LN-144, TIL for the treatment of metastatic melanoma, and LN-145, TIL for the treatment of cervical and head and neck cancers, to fund its planned clinical trials for its current product candidates, including its ongoing Phase 2 clinical trial of LN-145 for the treatment of non-small cell lung cancer, or NSCLC, in collaboration with MedImmune, and its ongoing Phase 2 clinical trials of Iovance TIL as an early-line therapy alone or in combination with pembrolizumab in melanoma, head and neck cancer, and NSCLC, and for other general corporate purposes. Additional indications may be explored with the use of proceeds.

Jefferies LLC is acting as sole book-running manager for the offering.

The shares of common stock described above are being offered by Iovance pursuant to its shelf registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (the "SEC"). The offering may be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at View Source A final prospectus supplement and accompanying prospectus will be filed with the SEC, copies of which may be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor New York, New York, 10022, by telephone at (877) 821-7388, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.