On November 6, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company focused on identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, reported financial results for the third quarter of 2018 and provided an update on its clinical development and commercial programs (Press release, Aclaris Therapeutics, NOV 6, 2018, View Source [SID1234530841]).

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In October, Aclaris entered into a definitive asset purchase agreement with Allergan Sales, LLC to acquire worldwide rights to RHOFADE (oxymetazoline hydrochloride) cream, 1% and additional intellectual property. The acquisition includes an exclusive license to certain intellectual property for RHOFADE, which is approved in the United States for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults. Aclaris expects this acquisition to close in the fourth quarter of 2018.

During the third quarter of 2018, total net revenue was $1.6 million, which consisted of net sales of ESKATA (hydrogen peroxide) Topical Solution, 40% (w/w) of $0.5 million and contract research revenue of $1.1 million.

In September, Aclaris initiated the Phase 3 program for A-101 45% Topical Solution (A-101 45%) for the treatment of common warts (verruca vulgaris).

Aclaris has completed enrollment in the ongoing AA-201 topical formulation trial of ATI-502 in patients with patchy alopecia areata (AA), a less severe phenotype of AA, data from which is expected in the first half of 2019.

"This is an exciting time for Aclaris. With the anticipated closing of the acquisition of RHOFADE in the fourth quarter, we will take another major step toward establishing ourselves as a fully integrated biopharmaceutical company with multiple commercial products, a robust clinical-stage pipeline and drug discovery engine," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.

Clinical Pipeline Update:

A-101 45% Topical Solution –

Initiated Phase 3 program (THWART-1 and THWART-2) for the treatment of common warts in September 2018. Topline data are expected in the second half of 2019.

Plan to commence an open-label safety extension trial investigating A-101 45% for the treatment of common warts in 2019.

JAK Inhibitor Trials:

AA-202 Topical –

An ongoing Phase 2 clinical trial of ATI-502, a topical JAK 1/3 inhibitor, for the treatment of AA.

Data from the full cohort of patients expected before year end.

After completing the 28-day portion of the trial, patients entered a 6-month open-label extension during which all continuing patients will receive drug. Treatment period extended in August 2018 for an additional 6 months to allow for full year of drug exposure.

Evidence of hair regrowth in the open-label extension portion of this trial has been observed.

Safety results – generally well-tolerated; no treatment related serious adverse events reported to date.

AUATB-201 Topical –

An ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of AA in Australia.

In this trial, Aclaris is evaluating the safety and efficacy of ATI-502 on the regrowth of eyebrows in patients with AA, including patients with alopecia totalis (AT) and alopecia universalis (AU). Interim update:

12 patients have been enrolled; 5 continue in the trial. Patients will also enroll in a 12 month extension phase of the trial after completing 6 months.

Evidence of eyebrow hair regrowth has been observed in two patients.

Safety results – generally well-tolerated; no treatment-related serious adverse events reported to date.

AA-201 Topical –

Completed enrollment of this ongoing Phase 2 clinical trial of ATI-502 for the topical treatment of AA.

This randomized, double-blinded, parallel-group, vehicle-controlled trial will evaluate the safety, efficacy and dose response of two concentrations of ATI-502 on the regrowth of hair in approximately 120 patients with AA. This trial is being conducted in the United States and data are expected in the first half of 2019.

VITI-201 Topical – Completed enrollment of this ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of vitiligo. This trial will evaluate the safety and efficacy of ATI-502 on the repigmentation of facial skin in 33 patients with vitiligo, and data are expected in 2019.

AGA-201 Topical – Completed enrollment of this ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of androgenetic alopecia (AGA), also known as male/female pattern hair loss. This trial will evaluate the safety and efficacy of ATI-502 on the regrowth of hair in 31 patients with AGA, and data are expected in the first half of 2019.

AD-201 Topical – an ongoing Phase 2 open-label clinical trial of ATI-502 in patients with atopic dermatitis (AD). This trial will evaluate the safety and efficacy of ATI-502 applied twice daily to affected skin for four weeks in approximately 30 adult patients with moderate-to-severe AD, and data are expected in mid-2019.

AUAT-201 Oral – an ongoing Phase 2 dose ranging trial of ATI-501, an oral JAK 1/3 inhibitor for the treatment of AA. This randomized, double-blinded, parallel-group, placebo-controlled trial will evaluate the safety, efficacy and dose response of three concentrations of ATI-501 on the regrowth of hair in approximately 80 patients with AA, and data are expected in the second half of 2019.

ATI-450 (MK-2 Inhibitor) – Investigational New Drug application on track for submission to the FDA in mid-2019.

Recent Corporate Highlights:

In October, Aclaris entered into a Loan and Security Agreement with Oxford Finance LLC. The Loan Agreement provides for up to $65 million in term loans. Of the $65 million, Aclaris borrowed $30 million on October 31, 2018. The remaining $35 million will become available for draw beginning on the closing date of the RHOFADE acquisition and ending on the earlier of March 31, 2019 or an event of default.

In October, Aclaris closed an underwritten public offering of 9,941,750 shares of Aclaris’ common stock at a price to the public of $10.75 per share, which includes the full exercise of the underwriters’ option to purchase 1,296,750 additional shares, for total gross proceeds of $106.9 million. Aclaris paid underwriting discounts and commissions of $6.4 million. All of the common stock in the offering was sold by Aclaris.

Issued US Patent # 10,098,910 – In October, Aclaris was issued a U.S. patent with 18 claims directed to an applicator containing a formulation of high concentration hydrogen peroxide and methods of using such an applicator to treat seborrheic keratosis (SK), warts and other indications, which is scheduled to expire in 2035. Orange Book listed.

Co-authored an article titled: "Inhibition of the Stromal p38MAPK/MK2 Pathway Limits Breast Cancer Metastases and Chemotherapy-Induced Bone Loss" in the journal Cancer Research. ATI-450, an investigational drug, is a selective inhibitor of p38 mitogen-activated protein kinase-activated protein kinase 2 (p38MAPK/MK2) interface and an attractive candidate for stromal-targeted therapy.

Commercial Update:

Over 1,050 ESKATA accounts opened to date.

Sales force focused on driving clinical and business integration in existing ESKATA accounts in addition to expanding account base.

National DTC campaign initiated on October 1.

Financial Highlights:

Third Quarter 2018 Financial Results

For the quarter ended September 30, 2018, total net revenues were $1.6 million, which consisted of net sales of ESKATA of $0.5 million and contract research revenue of $1.1 million, compared to $0.7 million for the quarter ended September 30, 2017, all of which was contract research revenue. For the nine months ended September 30, 2018, total net revenues were $6.4 million, which consisted of net sales of ESKATA of $2.0 million, contract research revenue of $3.4 million, and other revenue of $1.0 million, compared to $0.7 million for the nine months ended September 30, 2017, all of which was contract research revenue. Cost of revenues for the quarter and nine months ended September 30, 2018 were $1.2 million and $3.3 million, respectively, compared to $0.5 million for both the quarter and nine months ended September 30, 2017.

For the quarter ended September 30, 2018, total operating expenses were $33.9 million, compared to $19.0 million for the third quarter of 2017. For the nine months ended September 30, 2018, total operating expenses were $99.5 million, compared to $47.2 million for the same period in 2017.

Research and development (R&D) expenses for the quarter and nine months ended September 30, 2018 were $15.9 million and $43.5 million, respectively, compared to $10.9 million and $26.6 million, for the same periods of 2017. The increases of $5.0 million and $16.9 million were mainly the result of the expansion of Aclaris’ JAK inhibitor and common wart programs, as multiple Phase 2 trials of ATI-501 and ATI-502 and Phase 3 trials of A-101 45% are ongoing in 2018. There were also increases in medical affairs activities related to ESKATA and costs associated with drug discovery programs as a result of the acquisition of Confluence in August 2017. Personnel expenses, including stock-based compensation, increased due to increased headcount to support these programs and as a result of the acquisition of Confluence in August 2017. These increases were offset by a decrease in costs related to the development of ESKATA leading to Aclaris’ NDA submission in February 2017 following the completion of the clinical trials.

Sales and marketing (S&M) expenses for the quarter and nine months ended September 30, 2018 were $11.4 million and $35.0 million, respectively, compared to $3.6 million and $7.2 million, for the same periods of 2017. The increases of $7.8 million and $27.8 million were mainly the result of increases in direct marketing and professional fees, as well as other commercial expenses incurred to support the launch of ESKATA in May 2018. Personnel

expenses, including stock-based compensation, increased as Aclaris completed the hiring of its field sales force in the first quarter of 2018.

General and administrative (G&A) expenses for the quarter and nine months ended September 30, 2018 were $6.6 million and $21.0 million, respectively, compared to $4.6 million and $13.4 million, for the same periods of 2017. The increases of $2.0 million and $7.6 million were mainly the result of higher personnel expenses, including stock-based compensation, due to increased headcount to support the commercial launch of ESKATA, and as a result of the acquisition of Confluence in August 2017. G&A expenses for the nine months ended September 30, 2018 also included a $1.5 million ESKATA-related milestone payment, whereas the nine months ended September 30, 2017 included a $1.0 million ESKATA-related milestone payment.

For the quarter ended September 30, 2018, net loss was $32.7 million, or $1.06 per basic and diluted share, as compared to $18.2 million, or $0.63 per basic and diluted share, for the third quarter of 2017. For the nine months ended September 30, 2018, net loss was $94.2 million, or $3.04 per basic and diluted share, as compared to $45.6 million, or $1.68 per basic and diluted share, for the same period of 2017.

Liquidity and Capital Resources

As of September 30, 2018, Aclaris had aggregate cash, cash equivalents and marketable securities of $134.3 million compared to $208.9 million as of December 31, 2017.

Aclaris anticipates that its cash, cash equivalents and marketable securities balances, including the proceeds from the public offering of common stock in October and the initial drawdown from the loan facility with Oxford, will be sufficient to fund its operations into the second half of 2020, without giving effect to any potential new business development transactions or financing activities.

2018 Financial Outlook

Aclaris has updated its expected 2018 GAAP R&D expenses to be in the range of $62 to $64 million, including estimated stock-based compensation of $7 million.

Aclaris updated its expected 2018 GAAP selling, general and administrative (SG&A) expenses, which combine its Sales and marketing and General and administrative line items, to be in the range of $77 to $79 million, including estimated stock-based compensation of $14 million.

Company to Host Conference Call

Management will conduct a conference call at 5:00 PM ET today to discuss Aclaris’ financial results and provide a general business update. The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

On November 6, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported that the company will host and webcast an investor event on Friday, November 9, 2018 at 6:30 p.m. Eastern Time in Washington, D.C (Press release, Aduro Biotech, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375696 [SID1234530875]). The event will feature special guest speaker Jason J. Luke, M.D., FACP, Assistant Professor of Medicine at the University of Chicago and a principal investigator for the Phase 1 dose-finding studies of ADU-S100 (MIW815), a novel STING (stimulator of interferon genes) pathway activator. ADU-S100 is currently being evaluated as a single agent and in combination with spartalizumab (PDR001), an investigational anti-PD-1 compound in patients with advanced/metastatic solid tumors or lymphomas.

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To access the live webcast and subsequent archived recording of this and other company presentations, please visit the investor section of Aduro’s website at www.aduro.com. The archived webcast will remain available for replay on Aduro’s website for 30 days.

Aduro’s posters will be on display on Friday, November 9, 2018 from 8 a.m. – 8 p.m. ET and Saturday, November 10, 2018 from 8 a.m. – 8:30 p.m. ET in Hall E. at the Walter E. Washington Convention Center. Details of Aduro’s posters and oral presentations are as follows:

P309 Phase I dose-finding study of MIW815 (ADU-S100), an intratumoral
STING agonist, in patients with advanced solid tumors or lymphomas
Session: Rapid Oral Abstract Presentation Session
Date: Saturday, November 10, 2018, 1:00 p.m. ET
Location: Room 204ABC, Walter E. Washington Convention Center

P351 ADU-S100 (MIW815) Synergizes with Checkpoint Inhibition to Elicit an
Anti-Tumor CD8+ T Cell Response to Control Distal Tumors

P516 SIRPα blockade increases the activity of multiple myeloid lineage cells,
enhances dendritic cell cross-presentation, and aids in remodeling the
tumor microenvironment
Session: Concurrent Session 104: Immune Checkpoints – Beyond PD-1
Date/Time: Friday, November 9, 2018, 4:30 p.m. ET
Location: Hall D, Walter E. Washington Convention Center

P517 Pan-allele anti-SIRPα antibodies that block the SIRPα–CD47 innate
immune checkpoint

On November 6, 2018 Fortis Therapeutics, Inc., an immuno-oncology biotech developing a novel antibody-drug conjugate (ADC) against CD46, reported the U.S. Food and Drug Administration (FDA) has cleared two investigational new drug (IND) applications for the company’s lead candidate, FOR46, for the treatment of metastatic castration-resistant prostate cancer and late-stage multiple myeloma (Press release, Fortis Therapeutics, NOV 6, 2018, View Source [SID1234530937]). The Phase 1 trial of FOR46 in metastatic castration-resistant prostate cancer is planned to launch by the end of the year. The second program, in late-stage multiple myeloma, is expected to move into clinical trials in early 2019.

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FOR46 targets a novel immune modulatory receptor, CD46, which is highly expressed in multiple tumor types and is part of the tumor’s immune defense shield. While CD46 is expressed throughout the body, preclinical studies show that FOR46 activity is primarily restricted to prostate and other tumor tissue types, as opposed to normal tissue.

"CD46 is an attractive target for a number of cancers but has yet to be exploited due to its role in healthy tissues," said Jay Lichter, Ph.D., President and CEO of Fortis Therapeutics. "FOR46 cracks the code, in a sense, by binding a specific conformational epitope of CD46, that appears to be specific to tumor cells. This results in targeted tumor killing, while not impacting the natural role of CD46 in the complement system."

Discovery of FOR46

The FOR46 program originated at the University of California, San Francisco, in the laboratory of Bin Liu, Ph.D. It was identified through an antibody selection process that uses living tumor cells residing in their tissue microenvironment, thereby preserving the natural range of surface antigens present on the cells.

"It’s really a testament to the work of our scientists and the scientists at UCSF. By generating antibodies against tumor cells in situ, we developed a drug that readily translates to animal studies and, soon, human trials," said Marc Nasoff, Ph.D., Chief Scientific Officer of Fortis Therapeutics. "We’re confident in the science and in our therapeutic, which builds upon decades of innovation and refinement of antibody-drug conjugates."

To create FOR46, the fully human antibody was conjugated to a potent payload using a proven chemistry platform with well-characterized in vivo properties. Early in vitro studies of FOR46 have demonstrated its potential to kill tumor cells with no effect on normal cells. In rodents with human prostate cancer, it eliminated the tumor and led to long-term survival.

Fortis Therapeutics exclusively licensed rights to the antibody in 2016, and the company maintains a strong intellectual property position.

On November 6, 2018 Oncoceutics, Inc. reported that it will host an investigator meeting and that initial efficacy data of its lead compound ONC201 in patients with H3 K27M-mutant gliomas will be presented at the 2018 Annual Meeting of the Society for Neuro-Oncology in New Orleans, on November 15th to November 18th (Press release, Oncoceutics, NOV 6, 2018, View Source [SID1234558365]).

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The company, along with scientific and medical collaborators, will give 10 presentations that describe several aspects of ONC201, including clinical efficacy and safety, mediated via highly specific interaction with dopamine receptor 2 (DRD2), unique molecular characteristics, and novel insights on dopamine receptor dysregulation in glioma. Moreover, presentations will include the preclinical effectiveness and mechanism of action of ONC206, another molecule from this newly established class of compounds, called imipridones. One of the highlights of the event will be an oral presentation entitled, "Integrated clinical experience with ONC201 in previously-treated H3 K27M-mutant glioma patients," which scored highly in the review process of the SNO conference and will be one of three selected abstracts to be presented by a discussant separate from the oral presentation. The data set that will be disclosed will focus on radiographic and clinical responses in H3 K27M-mutant glioma patients from several clinical programs with ONC201.

"The reported findings are very meaningful for the medical community, and we look forward to sharing our experience with ONC201 in this first group of patients," said Yazmin Odia, MD, Lead Physician of Medical Neuro-Oncology, Miami Cancer Institute. "Patients with H3 K27M-mutant gliomas have a dismal prognosis, and there is currently no known effective drug for these patients."

Additionally, Oncoceutics will hold an investigator meeting for physicians involved in ongoing and future clinical trials with ONC201.

"We are conducting a number of clinical trials to translate these compelling findings into robust clinical data sets," said Wolfgang Oster, MD, PhD, and CEO of Oncoceutics. "We are excited about the progress in our development programs and hope that our findings will make a difference for patients with unmet medical need. We are grateful to the Society for Neuro-Oncology and its members for their interest and collaboration."

More Information: Imipridone-related SNO 2018 Abstracts

ONC201 glioma clinical experience (3 abstracts)

ACTR-34 (Talk): Integrated clinical experience with ONC201 in previously-treated H3 K27M-mutant glioma patients, Chi et al, Sunday November 18th, 8:50-9:00am
ACTR-33 (Talk): Tumor Tissue Penetration and Pharmacodynamics of ONC201 in Adult Recurrent Glioblastoma Patients, Arrillaga-Romany et al, Friday November 16th, 2:40-2:45pm
PDCT-06 (Talk): Phase I clinical trial of ONC201 in pediatric H3 K27M-mutant glioma or newly diagnosed DIPG, Gardner et al, Friday November 16th, 8:22-8:26pm
DRD2 dysregulation in glioma and ONC201 preclinical efficacy (4 abstracts)

DRES-10 (Talk): DRD5 is a modulator of glioma susceptibility to DRD2 antagonism by ONC201, Prabhu et al, Sunday November 18th, 11:25-11:30am
EXTH-26 (Poster): Molecular determinant of clinical response to ONC201, an inhibitor of dopamine receptor 2 (DRD2) signaling, in glioblastoma patients, Li et al, Saturday November 17th
DDIS-12 (Poster): ONC201: The first selective, non-competitive DRD2/3 antagonist for clinical neuro-oncology, Prabhu et al, Saturday November 17th
DDIS-16 (Poster): ONC201 in combination with radiation exhibits synergistic efficacy in high grade gliomas and other advanced cancers, Tarapore et al, Saturday November 17th
Utility of imipridone scaffold in neuro-oncology (3 abstracts)

EXTH-64 (Talk): Imipridones Cause Metabolic Reprogramming and Elicit Unique Vulnerabilities in Glioblastoma, Ishida et al, Friday November 16th, 8:06-8:10pm
EXTH-17 (Talk): Selective, non-competitive DRD2/3 antagonism by imipridone ONC206 is effective in tumors with dopamine receptor dysregulation, Prabhu et al, Friday November 16th, 8:02-8:06pm
EXTH-58 (Poster): ONC206, an imipridone family member, suppresses glioblastoma cells via blocking cancer stemness pathways, Jung et al, Saturday November 17th

On November 6, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported its third quarter 2018 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375637 [SID1234530753]).

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"We have made tremendous progress in the last several months. Following our recent end of Phase 2 meeting with the FDA, we released information about the meeting outcome and our US registration path, receipt of RMAT designation for metastatic melanoma, an abbreviated set of our latest clinical data, and conducted a successful round of financing. The company is now in a very strong financial position which will allow us to pursue our registration program to commercialize our TIL therapy," said Dr. Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "We intend to recruit a new cohort of patients in the C-144-01 study to support registration of lifileucel, build a commercial manufacturing facility as well as a commercial team to support our plans to bring lifileucel to patients, while we continue advancing our existing clinical programs and expand our TIL therapy into new indications."

Recent Achievements

Regulatory

Iovance received the Regenerative Medicine Advanced Therapy (RMAT) designation for lifileucel, the company’s adoptive cell therapy using its TIL technology for the treatment of patients with metastatic melanoma from the U.S. Food and Drug Administration (FDA).
Iovance held an end of Phase 2 meeting with FDA during which the agency acknowledged that a single-arm cohort as part of the C-144-01 study could be supportive of initial registration and conduct of a randomized Phase 3 trial in the patient population being enrolled may not be feasible.
Clinical

Enrollment in Cohort 2 of the global Phase 2 lifileucel metastatic melanoma study, C-144-01, reached the predefined sample size and was therefore closed.
— As announced today, new data from Cohort 2 will be presented in a poster and as an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C. on November 10-12. The presentation will include 47 consecutively dosed patients with an objective response rate (ORR) of 38%, with a median duration of response (DOR) of 6.4 months and range of 1.3+ to 14+ months. The ORR includes one complete response and 17 partial responses, four of which are unconfirmed and pending patient’s upcoming second assessments. Patients in the study had a mean of 3.3 prior systemic therapies and all the patients had received anti-PD-1 immunotherapy.
— The most common treatment emergent adverse events observed in this cohort to date include chills, febrile neutropenia, anaemia, decreased platelet count, pyrexia, and hypophosphataemia. There were two grade 5 events reported.
— Patient enrollment in a new cohort, Cohort 4, will be initiated in early 2019. This will be a single-arm cohort for registration in metastatic melanoma in a patient population that is post PD-1 blocking antibody and, if BRAF mutation positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor. Iovance expects to fully enroll the necessary patients into this cohort by late 2019/early 2020. Cohort 4 is expected to enroll 80-100 patients. The primary endpoint for the study is ORR as determined by Blinded Independent Central Review (BIRC).
Patient dosing continues in the C-145-04 study for cervical carcinoma. The company recently dosed its first patient in Europe. This study design is based on a Simon’s two-stage design. The first stage has been completed and enrollment in the study continues with target enrollment of 47. Preliminary data for 15 patients yielded an ORR of 27% with an early look at the DOR ranging from 2.4 to 2.5+ months. Patients in the study had a median of five prior therapies. The safety findings from this study remain consistent with previous reports. The protocol for this study has been amended to limit the number of prior therapies to no more than three and to exclude patients who have been treated with prior immunotherapy. Iovance anticipates providing an update on this study at an upcoming medical meeting in 2019.
In the C-145-03 study for head and neck cancer, to date, preliminary data for 13 patients has yielded an ORR of 31% with the DOR ranging from 2.8 to 7.6 months. The safety findings from this study is also consistent with previous reports. Patients in the study had a median of three prior therapies.
For the study in NSCLC, IOV-LUN-201, in collaboration with MedImmune, the company amended the protocol to eliminate the TIL monotherapy cohort and patients will now be enrolled for treatment with LN-145 and durvalumab. There are currently nine sites active for this trial.
The study in PD-1 naïve melanoma and head and neck patients with TIL in combination with pembrolizumab, and LN-145 as monotherapy in NSCLC patients (IOV-COM-202) is open to enrollment with two sites active.
As of October 2018, Iovance has expanded to over 90 clinical sites for its five company-sponsored studies.
Manufacturing

Iovance announced a new three-year Manufacturing Services Agreement with MaSTherCell S.A., a cell therapy-dedicated Contract Development and Manufacturing Organization (CDMO). MaSTherCell will manufacture TIL for Iovance’s European late-stage clinical trials in its commercial-ready cGMP manufacturing suites and increases Iovance’s capacity for manufacturing TIL in Europe.
Research

Under a collaboration with Ohio State University, Iovance has developed a product candidate called peripheral blood lymphocytes (PBLs). A clinical program to administer PBLs in chronic lymphocytic leukemia (CLL) patients is expected to begin in 2019.
Data from PD-1 selected TIL, one of the next generation TIL products at Iovance, will also be presented at SITC (Free SITC Whitepaper).
Corporate

In October 2018, the company closed an underwritten public offering of 25,300,000 shares of its common stock at a public offering price of $9.97 per share, before underwriting discounts. The shares sold at closing included 3,300,000 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 net proceeds from the offering, after deducting the underwriting discounts and commissions and other offering expenses payable by the company, were $236.6 million.
Two U.S. patent applications covering therapeutic methods based upon Generation 2 manufacturing, which was developed at Iovance, were recently allowed.
Third Quarter 2018 Financial Results

Net loss for the third quarter ended September 30, 2018 was $33.8 million, or $0.36 per share, compared to a net loss of $22.1 million, or $0.35 per share for the same period ended September 30, 2017.

Research and development expenses were $27.9 million for the third quarter ended September 30, 2018, an increase of $11.3 million compared to $16.7 million for the third quarter ended September 30, 2017. The increase was primarily attributable to a $4.8 million increase in clinical trial costs due to; higher patient enrollment and an increase in the number of sites in the clinical trial of lifileucel for the treatment of metastatic melanoma, increased enrollment in the cervical and head and neck LN-145 clinical trials and the initiation of clinical trials in 2018 for new indications. Further, payroll and related expenses, including stock-based compensation expenses increased by $4.4 million due to a higher number of full time employees and dedicated consultants as the company expanded its internal research efforts and clinical development programs. In addition, research and alliance costs increased by $1.4 million for clinical trials run by Iovance’s alliance partners and new research initiatives and $0.7 million for the expansion of manufacturing capacity at the company’s Clinical Manufacturing Organizations (CMOs).

General and administrative expenses were $7.1 million for the third quarter ended September 30, 2018, an increase of $1.4 million compared to $5.7 million for the third quarter ended September 30, 2017. The increase was primarily attributable to a $1.5 million increase in stock-based compensation expenses due to an increase in the number of full time employees and higher stock prices during the quarter as compared to the same period in 2017.

Nine Months Ended September 30, 2018 Financial Results

Net loss for the nine months ended September 30, 2018 was $91.0 million, or $1.01 per share, compared to a net loss of $66.2 million, or $1.06 per share for the same period ended September 30, 2017.

Research and development expenses were $72.4 million for the nine months ended September 30, 2018, an increase of $21.5 million compared to $50.9 million for the same period ended September 30, 2017. The increase was primarily attributable to a $11.9 million increase in the company’s clinical trial costs for ongoing and newly initiated studies and a $10.1 million increase in payroll and related expenses, including stock-based compensation expenses, for a higher number of full time employees and expenses for services performed by third parties in support of the company’s clinical studies. Further, research and research alliance costs increased by $1.1 million as Iovance expanded its research efforts and the number of clinical development programs run by its collaborators. These increases were partially offset by a $1.5 million decrease in manufacturing costs due to higher costs in 2017 related to technical transfer activities.

General and administrative expenses were $20.9 million for the nine months ended September 30, 2018, an increase of $5.0 million compared to $15.9 million for the same period ended September 30, 2017. The increase was primarily attributable to a $4.3 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 during 2018 and a $0.6 million increase in professional service and legal expenses.

At September 30, 2018, the company held $260 million in cash, cash equivalents, and short-term investments compared to $276.1 million at June 30, 2018. During the third quarter the company used $28.2 million for operating-related activities and received $12.1 million of proceeds from the exercise of warrants and stock options. In October 2018 the company received $236.6 in net proceeds from the issuance of common stock. The company anticipates that the year-end balance of cash, cash equivalents and short-term investments may be between $460 to $465 million.

Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m. ET to discuss these third quarter 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 access number for the call is 8718039. The live webcast can be accessed under "News & Events" in the "Investors" section of the company’s website at View Source or you may use the link: View Source

A replay of the call will be available from November 6, 2018 at 7:30 p.m. ET to November 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) and reference the access code 8718039. The archived webcast will be available for thirty days in the Investors section of Iovance Biotherapeutics’ website at View Source.