On August 9, 2017 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing novel vaccines and immunotherapies targeting T cell antigens, reported financial results for the second quarter of 2017 (Press release, Genocea Biosciences, AUG 9, 2017, View Source [SID1234520117]). Genocea is developing GEN-003, an investigational immunotherapy for the treatment of genital herpes, and is applying its unique and proprietary T cell antigen identification platform, ATLAS, to immuno-oncology and cancer vaccine development.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Highlights of the Second Quarter of 2017 and Recent Events

May 2017 – In its first quarter earnings report, Genocea announced (i) the successful completion of its end-of-Phase 2 meeting for GEN-003 with the U.S. Food & Drug Administration and (ii) data from its prior GEN-003 Phase 2 trial indicating that the initial course of injections sustained clinical and virologic efficacy for at least 24 months.
June 2017 – Genocea announced its addition to the Russell 3000 and Russell 2000 Indices as part of the annual reconstitution of those indexes.
July 2017 – Genocea reported positive top-line 12-month Phase 2b data for GEN-003 including statistically significant data on the expected Phase 3 primary endpoint with the Phase 3 dose, and positive results on multiple secondary clinical endpoints.
Chip Clark, president and chief executive officer of Genocea, commented: "We are delighted with the recent positive GEN-003 12-month Phase 2b data and continue to explore means of securing capital for this program to enable the start of Phase 3. We believe that, if approved, GEN-003 could become the first new therapy to treat genital herpes in more than 20 years and address serious unmet patient needs.

"With respect to our cancer vaccine program, recent scientific publications on neoantigen cancer vaccines suggest that the concept has promise, but we think that there is significant room for improvement. We believe that Genocea’s ATLAS platform can enable better neoantigen selection and that, combined with our vaccinology expertise, positions us strongly in this emerging field. We expect to file an IND by the end of 2017 for our neoantigen vaccine, GEN-009, and we are also continuing our pre-clinical work on common antigen cancer vaccines and an EBV-related cancer vaccine."

Financial Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operating expenses and capital expenditure requirements into 2018. Genocea is currently exploring various avenues to secure capital to advance GEN-003 into Phase 3 trials and does not intend to commence Phase 3 development of GEN-003 until it has secured such capital.

Second-Quarter 2017 Financial Results

Cash Position: Cash and cash equivalents as of June 30, 2017 were $35.2 million compared to cash, cash equivalents and investments of $48.7 million as of March 31, 2017.
Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2017 increased $4.7 million, to $11.4 million, from the same period in 2016. The increase was primarily driven by higher external manufacturing-related expenses and increases in compensation, consulting and professional services to support both the clinical drug supply and clinical planning activities in support of GEN-003 Phase 3 program readiness. Spending increases on Genocea’s immuno-oncology and cancer vaccine programs were driven primarily by increased manufacturing and compensation, consulting and professional services in anticipation of Genocea’s expected filing of an Investigational New Drug (IND) application for GEN-009 in 2017. Increased spending on these programs was offset by lower costs on deprioritized infectious disease programs.
General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2017 were $3.6 million, compared to $4.0 million for the same period in 2016 reflecting lower depreciation costs and lower consulting and professional services costs.
Net Loss: Net loss was $15.4 million for the quarter ended June 30, 2017, compared to a net loss of $11.0 million for the same period in 2016.

On August 9, 2017 Genmab reported Interim Report for the First Half of 2017 (Press release, Genmab, AUG 9, 2017, View Source [SID1234520116]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Highlights
USD 554 million in net sales of DARZALEX (daratumumab); resulting in royalty income of DKK 454 million

DARZALEX approved by U.S. Food and Drug Administration (FDA) in combination with pomalidomide and dexamethasone for relapsed or refractory multiple myeloma

DARZALEX received European regulatory approval in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for relapsed or refractory multiple myeloma

Announced Phase III study combining daratumumab with pomalidomide and dexamethasone in multiple myeloma

Announced plans for new studies of daratumumab in smoldering multiple myeloma and with subcutaneous formulation in amyloidosis and multiple myeloma

Reported preliminary Phase I/II tisotumab vedotin data in cervical cancer

"It’s been another exciting and busy quarter, with highlights including further DARZALEX label expansions allowing for a broader number of multiple myeloma patients to be treated with the drug, as well as the announcement of a number of new pivotal studies with daratumumab. In addition we announced encouraging data from our ongoing Phase I/II tisotumab vedotin trial and have been working hard on progressing projects in our innovative pipeline," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Half of 2017
Revenue was DKK 1,024 million in the first half of 2017 compared to DKK 524 million in the first half of 2016. The increase of DKK 500 million, or 95%, was mainly driven by higher DARZALEX royalties and milestones.

Operating expenses were DKK 442 million in the first half of 2017 compared to DKK 366 million in the first half of 2016. The increase of DKK 76 million, or 21%, was due to the additional investment in our pipeline of products, including the advancement of tisotumab vedotin, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and other products in our pipeline.

Operating income was DKK 582 million in the first half of 2017 compared to DKK 158 million in the first half of 2016. The increase of DKK 424 million, or 268%, was driven by higher revenue, which was partly offset by increased operating expenses in 2017.

On June 30, 2017, Genmab had a cash position of DKK 5,215 million compared to DKK 3,922 million at December 31, 2016. This represented a net increase of DKK 1,293 million, which was mainly driven by positive working capital adjustments of DKK 630 million related to milestones achieved in the fourth quarter of 2016 that were received in 2017, our operating income of DKK 582 million, and proceeds from the exercise of warrants of DKK 194 million.

On August 9, 2017 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, reported financial results and recent corporate highlights for the second quarter ended June 30, 2017 (Press release, Fortress Biotech, AUG 9, 2017, View Source [SID1234520115]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Lindsay A. Rosenwald, Fortress’ Chairman, President and Chief Executive Officer, said, "Fortress and our Fortress subsidiaries achieved important corporate and clinical milestones during the second quarter of 2017. Avenue Therapeutics completed a $38 million initial public offering, and is on track to initiate a Phase 3 clinical trial in the third quarter of IV tramadol in patients undergoing bunionectomy surgery. If approved, IV tramadol will be the only intravenous Schedule IV opioid for use in the United States. Avenue, along with Checkpoint Therapeutics, began trading their common shares on The NASDAQ Capital Market during the last week of June. In addition, Caelum Biosciences announced the dosing of the final patient in a Phase 1b clinical trial of its lead therapy, CAEL-101, in AL amyloidosis, with a data readout expected in the second half of 2017. Mustang Bio licensed three CAR T cell therapies from its research partner City of Hope, expanding its pipeline to five novel CAR T candidates."

Dr. Rosenwald continued, "Our strong business development engine continues to deliver on our goal of acquiring novel pharmaceutical and biotechnology products for development within Fortress and through our Fortress Companies. We look forward to continuing to execute on our business plan and reaching important milestones in the third quarter to add value for our shareholders."

Financial Results:

· As of June 30, 2017, Fortress’ consolidated cash and cash equivalents totaled $144.3 million, compared to $134.0 million at March 31, 2017, and $88.3 million at December 31, 2016, an increase of $10.3 million for the quarter and $56.0 million year-to-date. These totals as of June 30, 2017 exclude short-term investments of $20.0 million, restricted cash of $15.9 million and cash deposits with clearing organizations of $1.0 million.
· Net revenue totaled $50.7 million for the second quarter of 2017 and $95.4 million for the first six months of 2017, compared to $2.2 million for the second quarter of 2016 and $2.9 million for the first six months of 2016. Net total revenue for the second quarter ended June 30, 2017 includes $4.4 million of Fortress revenue and $46.3 million of revenue from National Holdings Corporation ("National"), which Fortress acquired in September 2016, with no revenue attributable to National prior to the acquisition.
· Research and development expenses were $11.7 million for the second quarter of 2017, of which $10.0 million was related to Fortress Companies, and $18.8 million for the first six months of 2017, of which $15.8 million was related to Fortress Companies. This compares to $6.3 million for the second quarter of 2016, of which $4.0 million was related to Fortress Companies, and $14.1 million for the first six months of 2016, of which $9.0 million was related to Fortress Companies. Non-cash stock-based compensation expense included in research and development for the second quarter of 2017 was $2.4 million, compared to $1.1 million for the second quarter of 2016, and $3.2 million for the first six months of 2017, compared to $2.4 million for the first six months of 2016.
· Research and development expenses from license acquisitions totaled $1.8 million for the second quarter of 2017 and $3.1 million for the first six months of 2017, compared to $2.0 million for the second quarter of 2016 and $2.1 million for the first six months of 2016.




· General and administrative expenses were $11.1 million for the second quarter of 2017, of which $7.0 million was related to Fortress Companies, and $21.4 million for the first six months of 2017, of which $12.8 million was related to Fortress Companies. This compares to $8.6 million for the second quarter of 2016, of which $3.7 million was related to Fortress Companies, and $16.6 million for the first six months of 2016, of which $6.6 million was related to Fortress Companies. Non-cash stock-based compensation expenses included in general and administrative expenses were $2.2 million for the second quarter of 2017, compared to $1.9 million for the second quarter of 2016, and $4.3 million for the first six months of 2017, compared to $3.5 million for the first six months of 2016.
· National’s operating expenses totaled $48.4 million for the second quarter of 2017 and $91.5 million for the first six months of 2017, with no expenses attributable to National prior to Fortress’ acquisition of the company in September 2016.
· Net loss attributable to common stockholders was $17.4 million, or $0.43 per share, for the second quarter of 2017, compared to a net loss attributable to common stockholders of $12.5 million, or $0.31 per share, for the second quarter of 2016. For the first six months of 2017, net loss was $29.3 million or $0.73 per share, compared to $24.7 million or $0.62 per share in the first six months of 2016.

Recent Fortress Biotech and Fortress Company Highlights:

Fortress Biotech, Inc.
· In June 2017, Ms. Robyn Hunter was named Chief Financial Officer of Fortress. Lucy Lu, M.D., Fortress’ former Chief Financial Officer, was appointed President and Chief Executive Officer of Fortress subsidiary Avenue Therapeutics, Inc.
· As of June 30, 2017, Fortress raised a total of $19.0 million in a Subordinated Note Financing; $15.7 million of the $19.0 million was raised in the second quarter of 2017. National Securities Corporation, a subsidiary of National, acted as the Placement Agent.

Avenue Therapeutics, Inc.
· In May 2017, Avenue received a Notice of Allowance from the U.S. Patent and Trademark Office ("USPTO") for a new patent application (U.S. Application No. 15/163,111) titled "Intravenous Administration of Tramadol." The patent application describes and claims a dosing regimen of intravenous ("IV") 50 mg tramadol that provides certain pharmacokinetic parameters that are similar to those of 100 mg tramadol HCl administered orally every six hours at a steady state. Issuance of the patent (U.S. Patent No. 9,693,949) occurred in July 2017. This patent application falls under Avenue’s licensing agreement with Revogenex Ireland Ltd.
· On June 30, 2017, Avenue completed its initial public offering of 6,325,000 shares of common stock, at a public offering price of $6.00 per share, for a total offering size of $37,950,000, before deducting underwriting discounts and offering expenses. The shares sold include 825,000 that were subject to an underwriters’ overallotment option, which was exercised and closed concurrently with the closing of the initial public offering. Avenue’s common stock began trading on The NASDAQ Capital Market under the ticker symbol "ATXI."
· Also in June 2017, Lucy Lu, M.D., was named President and Chief Executive Officer of Avenue, a position she held on an interim basis since the company’s inception.

Caelum Biosciences, Inc.
· In April 2017, the U.S. Department of Health & Human Services confirmed the transfer of two U.S. Food and Drug Administration ("FDA") Orphan Drug Designations for CAEL-101 from Columbia University ("Columbia") to Caelum. The designations cover use as a therapeutic agent for patients with AL amyloidosis and use as a radio-imaging agent in amyloidosis. Caelum in-licensed CAEL-101 from Columbia in January 2017.
· In May 2017, Columbia dosed the final patient in the Phase 1b trial of CAEL-101 in AL amyloidosis. As of July 2017, all patients completed treatment. Preliminary and full Phase 1b data are expected in the second half of 2017.
· Also in May 2017, Caelum entered a biopharmaceutical manufacturing agreement with Patheon N.V. for process development and current good manufacturing practices (cGMP) production to support Phase 2/3 studies of CAEL-101.
· In June 2017, Columbia filed a provisional patent application with the USPTO pertaining to CAEL-101 that, once converted into a U.S. non-provisional utility application, will provide composition of matter protection effective upon a grant of a U.S. patent. The legal protection offered by a granted U.S. patent will exceed any data exclusivity periods associated with Orphan Drug Designation and/or an original, branded-biologic product approved for marketing in the U.S. Just this month, Columbia filed a second provisional patent application with the USPTO to pursue additional method of treatment claims directed to surprising and positive outcomes observed from the Phase 1b trial of CAEL-101. If granted these new claims provide an additional layer of legal protection for the use of Caelum’s lead product candidate.

Checkpoint Therapeutics, Inc.
· In April 2017, Checkpoint presented preclinical data on CK-101, an epidermal growth factor receptor ("EGFR") inhibitor, and CK-301, an anti-programmed cell death ligand-1 ("PD-L1") antibody, in poster sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting.
· In June 2017, Checkpoint’s common stock began trading on The NASDAQ Capital Market under the ticker symbol "CKPT."

On August 9, 2017 Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) ("Cyclacel" or the "Company"), a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases, reported its financial results and business highlights for the second quarter ended June 30, 2017 (Press release, Cyclacel, AUG 9, 2017, View Source [SID1234520114]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company’s net loss applicable to common shareholders for the three months ended June 30, 2017 was $2.2 million or $0.50 per share, compared to net loss applicable to common shareholders of $3.0 million, or $1.01 per share for the second quarter of 2016. As of June 30, 2017, cash and cash equivalents totaled $13.6 million. Pro forma cash and cash equivalents as of June 30, 2017 totaled $27.4 million after including $13.8 million in proceeds, net of expenses, received in the Company’s underwritten offering completed on July 21, 2017.

"As a result of the completion of our recent offering, in which existing and new investors participated, we are able to advance the clinical investigation of CYC065, our Cyclin Dependent Kinase (CDK) 2/9 inhibitor, in selected, molecularly-defined patient populations," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We have selected a recommended Phase 2 dose for CYC065 from part 1 of a dose-escalating, Phase 1, first-in-human, study of CYC065. Data from this study evidenced durable target engagement and Mcl-1 biomarker suppression at well tolerated doses with initial evidence of anticancer activity in patients with Mcl-1 and/or cyclin E overexpression or amplification. Our top priority is to finalize designs for a Phase 1/2 study testing CYC065 in combination with venetoclax, a Bcl-2 inhibitor approved for chronic lymphocytic leukemia, an indication in which we believe Mcl-1 suppression may be beneficial. In parallel, we will enroll a new part 2 of the Phase 1 study in patients with advanced solid tumors testing additional dosing schedules. We look forward to reporting our progress, commencement of these studies and data, as they arise."

Business Highlights

Transcriptional Regulation Program: CYC065 CDK inhibitor

Selected a recommended Phase 2 dose (RP2D) from part 1 of a dose-escalating, Phase 1, first-in-human, clinical study. RP2D was determined at dosing level 6, which enrolled 10 patients with advanced cancers. Prolonged reduction of the Mcl-1 biomarker was observed in 7 out of 9 evaluable patients for at least 24 hours following a single dose of CYC065, which was generally well tolerated. Preliminary anticancer activity was observed in three patients with Mcl-1, MYC and Mcl-1/cyclin E amplified cancers. The trial is being conducted at the Dana Farber Cancer Institute in Boston.

Part 2 of the study will enroll patients with advanced solid tumors, in particular cyclin E amplified tumors. Such tumors include subsets of high grade serous ovarian and uterine cancers. Part 2 will evaluate CYC065 in a more intensive schedule for 2 days per week, for 2 weeks of a three-week cycle. Biospecimens will be collected for assessment of biomarkers related to CYC065’s mechanism of action.
SEAMLESS Study

An abstract of the results of the Phase 3 study of oral sapacitabine in elderly patients with acute myeloid leukemia (AML) has been submitted to the American Society of Hematology (ASH) (Free ASH Whitepaper), and if accepted, will be the subject of an oral or poster presentation at the 59th ASH (Free ASH Whitepaper) Annual Meeting to be held December 9 – 12, 2017.
July Underwritten Offering

On July 21, 2017, the Company announced the closing of an underwritten offering, with net proceeds of approximately $13.8 million after deducting underwriting discounts and commissions and other estimated offering expenses, including full exercise of the underwriters’ overallotment option. The Company issued and sold in the offering (i) 3,154,000 Class A Units, each consisting of one share of the Company’s common stock, and a warrant to purchase one share of common stock, and (ii) 8,872 Class B Units, each consisting of one share of the Company’s Series A Convertible Preferred Stock convertible into 500 shares of common stock at the initial conversion price, and a warrant to purchase a number of shares of common stock equal to $1,000 divided by the conversion price. The price to the public in the offering was $2.00 per Class A Unit and $1,000 per Class B Unit.

Subsequent to the closing of the offering, holders of 7,613 (86%) shares out of 8,872 shares outstanding of Series A Preferred Stock elected to convert their shares into 3,806,500 shares of common stock. Following such conversions, 11,400,447 shares of common stock and 1,259 (14%) shares of Series A Preferred Stock remain outstanding as of August 8, 2017.
Financial Highlights
As of June 30, 2017, cash and cash equivalents totaled $13.6 million, compared to $16.5 million on December 31, 2016. After the July offering, pro forma cash and cash equivalents are $27.4 million.

Revenue for the three months ended June 30, 2017 were $0 compared to $0.2 million for the same period of the previous year. Revenue is primarily related to previously awarded grants from the UK government being recognized over the period to progress IND-directed preclinical development of CYC140, a novel, orally available, Polo-Like Kinase 1 (PLK 1) inhibitor, completed in November 2016.

Research and development expenses were $1.2 million compared to $2.6 million for the same period in 2016. The decrease was primarily due to reduced study and clinical supply costs associated with completion of the SEAMLESS study and completion of preclinical development of CYC140.

General and administrative expenses for the three months ended June 30, 2016 and 2017 remained flat at $1.3 million.

Other income (expense), net for the three months ended June 30, 2017 was $34,000, compared to $0.2 million for the same period of the previous year. The decrease in other income (expense) is primarily related to foreign exchange movements.

The UK government research & development tax credit for the quarter was $0.3 million, compared to $0.6 million for the same period of the previous year. During the quarter, we also recognized cash received for the 2016 tax credit of $1.8 million.

Net loss for the three months June 30, 2017 was $2.2 million compared to $3.0 million for the same period in 2016.

On August 9, 2017 Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported financial results for the second quarter ended June 30, 2017 and provided an update on the Company’s recent corporate and operational highlights (Press release, Argos Therapeutics, AUG 9, 2017, View Source [SID1234520113]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Despite what has clearly been a challenging period, Argos made substantial progress during the most recent quarter," stated Jeff Abbey, CEO of Argos Therapeutics. "First, we were pleased to have a constructive meeting with the FDA, which agreed with our decision to continue the Phase 3 ADAPT trial of Rocapuldencel-T for the treatment of metastatic renal cell carcinoma until we reach 290 events, the pre-specified number of events at which the analysis of overall survival, the primary endpoint, is to be conducted. We are grateful to our investigators and patients for their continued support of our efforts, and we look forward to our next planned analysis at 290 events, which we expect to occur during the first half of 2018."

"In addition, we are preparing a protocol amendment and a revised statistical analysis plan seeking to extend the final data analysis beyond 290 events, which the FDA has agreed to review. We believe that this extension would enable us to better account for the potential delayed treatment effect of Rocapuldencel-T. Also of note, Robert Figlin, MD, Professor and Chairman, Division of Hematology and Oncology at Cedars Sinai Medical Center, co-principal investigator of the ADAPT trial, will provide an overview of interim data from the ADAPT trial in an oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meeting to be held September 8 — 12 in Madrid."

"Second, we were pleased to report positive immunogenicity data in our development program for AGS-004 for the treatment of HIV, which is funded by the NIH and the NIAID. We look forward to results from the current trial, which is being conducted at the University of North Carolina, to assess the potential ability of AGS-004, in combination with vorinostat, a latency-reversing agent, to eradicate the HIV virus in adult patients. Despite several effective therapies for HIV, there is currently no agent capable of eradicating the virus."

"Finally, we were pleased to complete a $6.0 million secured convertible note financing with our collaborator and largest shareholder, Pharmstandard. In addition, we took significant steps during the quarter to reduce our expense structure, including a substantial reduction of our workforce. These measures, coupled with proceeds we have recently raised through our at-the-market issuance facility, have enabled us to extend our operational runway. "

Second Quarter 2017 and Recent Operational Highlights:

In May 2017, the Company reported that the FDA agreed with the Company’s plan to continue the ADAPT trial until the Company reaches 290 events, the pre-specified number of events at which the analysis of overall survival, the primary endpoint, is to be conducted, and that the FDA agreed to review a protocol amendment and revised statistical analysis plan that would extend the trial beyond the originally planned 290 events, which the Company believes could enhance its ability to detect whether Rocapuldencel-T has a delayed treatment effect
In June 2017, the Company announced the closing of a $6.0 million secured convertible note financing with Pharmstandard
In July 2017, the Company reported positive immunogenicity data in its AGS-004 dendritic cell therapy program for the treatment of adult patients with acute HIV infection
Selected Second Quarter 2017 Financial Results

Revenue for the three months ended June 30, 2017 was $70,000 compared to $489,000 for the same period in 2016. The decrease in revenue for the second quarter of 2017 compared with the second quarter of 2016 resulted from lower reimbursement under the Company’s contract with the NIH and NIAID primarily related to the achievement of certain specified development milestones under the Company’s AGS-004 program during 2016.

Research and development expense for the three months ended June 30, 2017 was $5.1 million compared to $9.2 million for the same period in 2016. The decrease in research and development expense for the second quarter of 2017 compared with the second quarter of 2016 was primarily due to the Company’s decision to significantly reduce the size of its workforce engaged in research and development activities following the recommendation of the IDMC to discontinue the ADAPT trial.

General and administrative expense for the three months ended June 30, 2017 was $2.7 million compared to $3.4 million for the same period in 2016. The decrease in general and administrative expense for the second quarter of 2017 compared with the second quarter of 2016 was primarily due to reduced consulting and personnel costs.

Reflecting the factors noted above, net loss for the three months ended June 30, 2017 was $8.5 million compared to a net loss of $12.6 million for the same period in 2016.

Revenue for the six months ended June 30, 2017 was $175,000 compared to $635,000 for the same period in 2016. The decrease in revenue for the first half of 2017 compared with the first half of 2016 resulted from lower reimbursement under the Company’s contract with the NIH and NIAID primarily related to the achievement of certain specified development milestones under the Company’s AGS-004 program during 2016.

Research and development expense for the six months ended June 30, 2017 was $13.0 million compared to $18.7 million for the same period in 2016. The decrease in research and development expense for the first half of 2017 compared with the first half of 2016 was primarily due to reduced expenses associated with the Phase 3 ADAPT trial and the Company’s decision to significantly reduce the size of its workforce engaged in research and development activities following the recommendation of the IDMC to discontinue the ADAPT trial.

General and administrative expense for the six months ended June 30, 2017 was $6.6 million compared to $6.4 million for the same period in 2016. The increase in general and administrative expense for the first half of 2017 compared with the first half of 2016 was primarily due to increased personnel costs.

Additionally, the Company incurred impairment charges of $27.2 million and restructuring charges of $5.4 million during the six months ended June 30, 2017 related to the Company’s decision to discontinue preparation for commercial manufacturing and reduce the size of its workforce, which amounts were partially offset by a non-cash gain due to the decrease in the value of the warrant liability of $20.2 million.

Reflecting the factors noted above, net loss for the six months ended June 30, 2017 was $32.6 million compared to a net loss of $25.4 million for the same period in 2016.

As of June 30, 2017, cash and cash equivalents totaled $9.3 million.