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Celsion Corporation Reports Third Quarter 2018 Financial Results and Provides Business Update

On November 14, 2018 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported financial results for the quarter and nine-month period ended September 30, 2018 and provided an update on development program progress for ThermoDox, the company’s lead product candidate currently in Phase III development for the treatment of primary liver cancer, and GEN-1, an immunotherapy currently in Phase I/II development for the localized treatment of ovarian cancer (Press release, Celsion, NOV 14, 2018, View Source [SID1234531486]).

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"During the last quarter Celsion made excellent progress with our clinical development programs, including completion of enrollment in our 550-patient global, pivotal Phase III OPTIMA Study of ThermoDox in primary liver cancer in August 2018, as expected, and initiation of patient enrollment in our 130-patient follow-on Phase I/II randomized OVATION 2 Study of GEN-1 in patients newly diagnosed with ovarian cancer," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "We continue to maintain a tight operational focus that both conserves cash and enables the timely execution of clinical trials for both of our promising product candidates. In combination with a financing strategy that minimizes dilution and focuses on shareholder value, we have established a cash runway that extends well beyond the time frame necessary to realize the transformational milestones that lie ahead over the next 18 months. In October 2018, we took steps to eliminate the warrant overhang created from our earlier financings in 2016 and 2017 resulting in a clean capitalization structure."

Recent Developments

Enrollment Completed for 550-Patient Global, Pivotal Phase III OPTIMA Study of ThermoDox in Primary Liver Cancer. In September 2018, the Company announced completion of enrollment of 550 patients in the Company’s pivotal, Phase III OPTIMA Study, a multinational, randomized, double-blind, placebo-controlled clinical trial of ThermoDox in combination with radiofrequency ablation (RFA) for the treatment of patients with hepatocellular carcinoma (HCC), also known as primary liver cancer. The primary endpoint for the study is overall survival (OS). The first of two planned interim efficacy analyses by the study’s Data Monitoring Committee (DMC) is expected in mid-2019.

First Patient Randomized in the Gene-Mediated Immunotherapy (GEN-1) Study of Newly Diagnosed Patients With Stage III/IV Ovarian Cancer. In September 2018, the first patient was dosed in the OVATION 2 Study, a randomized, Phase I/II clinical trial of GEN-1, the Company’s DNA-based immunotherapy for the localized treatment of ovarian cancer as an adjuvant to chemotherapy current standard of care. OVATION 2 will be conducted at 10 treatment centers in the U.S. and will include up to 130 patients with Stage III/IV ovarian cancer, with 12 patients in the Phase I portion and up to 118 patients in Phase II.

Final Progression-Free Survival (PFS) Data From GEN-1 Phase IB Gene-Mediated Immunotherapy Study of Patients With Stage III/IV Ovarian Cancer. In October 2018, Celsion announced final clinical results from the dose escalating Phase IB OVATION I trial evaluating neoadjuvant chemotherapy (NAC) and GEN-1 in newly diagnosed patients with Stage III/IV ovarian cancer. Median PFS in patients treated per protocol (n=13) was 24.3 months and was 17.1 months for the intent-to-treat population (n=18) for all dose cohorts, including three patients who dropped out of the study after 13 days or less, and two patients who did not receive full NAC and GEN-1 cycles.

Program Overview of Celsion’s Gene-Mediated Immunotherapy Designed to Improve Administration of IL-12 and PFS in Patients With Ovarian Cancer Published in the Peer-Reviewed Journal, Future Oncology. In October 2018, an overview of GEN-1 was published in the peer-reviewed journal Future Oncology. The article, co-authored by Premal H. Thaker, M.D., M.S., associate professor of obstetrics and gynecology at the Siteman Cancer Center at the Washington University School of Medicine in St. Louis, Mo. and principal investigator in Celsion’s GEN-1 development program, outlines the DNA plasmid, gene-based concept and the key attributes supporting GEN-1’s mechanism of action characterized by local and persistent delivery of IL-12 and modulation of the tumor microenvironment favoring immune stimulation.

Corporate Development

Celsion’s Application to Sell its New Jersey State Net Operating Losses (NOLs) for the Tax Years 2011 to 2017 Approved. In September 2018, the Company announced it has received approval from the New Jersey Economic Development Authority’s (NJEDA) Technology Business Tax Certificate Transfer program to sell the Company’s unused New Jersey State NOLs and R&D tax credits, totaling $12.5 million for the tax years 2011 to 2017. The Company anticipates that successful transfer of these credits will result in receipt of approximately $10 million in net cash proceeds to the Company prior to the end of 2018.

Elimination of Warrant Overhang

In October 2018, the Company and certain investors holding warrants to collectively purchase 1.64 million shares of the Company’s common stock, which were received in the February 2017 Public Offering and the October 2017 Underwritten Offering, entered into warrant exchange agreements whereby the Company issued 820,714 shares of its common stock in exchange for the warrants. The Company exchanged 0.5 share of common stock for each of 1.64 million warrants with exercise prices between $3.00 per share and $3.22 per share. Doing so, the Company believes that it has eliminated the warrant overhang on its share price and the potential to use these warrants as a vehicle to hedge a short position. As of November 14, 2018, the Company has 18.7 million shares outstanding and 1.6 million warrants outstanding, of which 1.2 million of these outstanding warrants have an exercise price over $6.00 per share and will expire in early April 2019.

Financial Results

For the quarter ended September 30, 2018, Celsion reported a net loss attributable to common shareholders of $4.7 million, or a loss of $0.26 per share, compared to a loss of $5.7 million, or a loss of $0.70 per share, in the same period of 2017. Operating expenses were $4.1 million in the third quarter of 2018, which represented an 8% decrease from $4.5 million in the same period of 2017. During the third quarter ended September 30, 2018, the Company incurred $0.6 million in non-cash stock option expense compared to $0.1 million in the third quarter of 2017.

For the nine-month period ended September 30, 2018, the Company reported a net loss attributable to common shareholders of $17.4 million, or a loss of $1.00 per share, compared to a loss of $16.1 million, or a loss of $3.04 per share, in the same nine-month period of 2017. Operating expenses were $16.7 million during the first nine months of 2018 compared to $14.2 million in the same period of 2017. During the first nine months of 2018, the Company incurred $4.0 million in non-cash stock option expense compared to $1.0 million in the comparable nine-month period of 2017.

Net cash used for operating activities was $13.1 million in the first nine months of 2018, compared to $12.4 million in the same nine-month period in 2017. The Company ended the third quarter of 2018 with $22.0 million of total cash, cash equivalents, investment securities and interest receivable, which included $10 million in gross proceeds from the Company’s venture debt facility completed on June 27, 2018 with Horizon Technology Finance Corporation. The Company expects to receive approximately $10 million from the sale of its New Jersey state NOLs in the fourth quarter of 2018, which is expected to contribute to funding operations into the fourth quarter of 2020.

Research and development (R&D) expenses decreased by $1.1 million, from $3.3 million in the third quarter of 2017 to $2.2 million in the third quarter of 2018. Costs associated with the OPTIMA Study decreased by $1.1 million to $0.7 million in the third quarter of 2018 compared to $1.8 million in the same period of 2017. This decrease resulted from cost concessions negotiated with the Company’s lead contract research organization (CRO) for the OPTIMA Study as well as lower monthly CRO fees after completion of enrollment of this Phase III study during the third quarter of 2018. Costs associated with the initiation of the OVATION 2 Study were $0.2 million in the third quarter of 2018. Other R&D costs related to clinical supplies and regulatory support for the ThermoDox development program decreased by $0.2 million in the third quarter of 2018 when compared to the same prior-year period.

R&D expenses decreased by $0.4 million, from $9.9 million in the first nine months of 2017 to $9.5 million in the first nine months of 2018. Clinical development costs for the Phase III OPTIMA Study decreased to $4.0 million in the first half of 2018, compared to $4.9 million in the first nine months of 2017. This decrease of $0.9 million resulted from cost concessions negotiated with the lead CRO for the OPTIMA Study as well as lower monthly CRO fees after completion of enrollment of this Phase III study during the third quarter of 2018. Costs associated with the initiation of the OVATION 2 Study were $0.4 million in the first nine months of 2018. Other R&D costs related to clinical supplies and regulatory support for the ThermoDox and GEN-1 clinical development programs increased by $0.2 million in the first nine months of 2018 when compared to the same prior-year period. In the first nine months of 2018, the Company also incurred an increase of $0.8 million in non-cash stock compensation expense, compared to the same period of 2017. Partially offsetting these increased costs was a plan implemented by the Company in the first half of 2017 designed to reduce costs associated with the support of ThermoDox clinical studies and other initiatives in Europe. The majority of the $0.5 million in cost savings for personnel and support services in Europe were realized in the first half of 2017.

General and administrative (G&A) expenses were $2.0 million in the third quarter of 2018, compared to $1.2 million in the same period of 2017. General and administrative expenses were $7.2 million in the first nine months of 2018, compared to $4.3 million in the same period of 2017. These increases were primarily attributable to (i) an increase in non-cash stock compensation expense totaling $0.4 million in the third quarter of 2018 and $2.0 million in the first nine months of 2018 when compared to the same periods in 2017 and (ii) an increase in professional fees of approximately $0.2 million in the third quarter of 2018 and $0.7 million in the first nine months of 2018 primarily related to recruiting fees for several new positions to support the anticipated regulatory and commercialization efforts for ThermoDox.

During the third quarter ended September 30, 2018, other expenses included a non-cash charge of $4.5 million related to the impairment of certain in-process research and development assets related to the development of our glioblastoma multiforme (GBM) cancer product candidate offset by a $4.1 million reduction in the earn-out liability related to potential milestone payments for the GBM product candidate. During the third quarter ended September 30, 2017, other expenses included a non-cash charge of $2.5 million related to the impairment of certain in process research and development assets related to the development of our GBM) cancer product candidate offset by a $1.2 million reduction in the earn-out liability related to potential milestone payments for the GBM product candidate.

During the nine-month period ended September 30, 2017, the Company recognized deemed dividends totaling $0.4 million related to multiple agreements with certain warrant holders, pursuant to which these warrant holders agreed to exercise, and the Company agreed to reprice, certain warrants. Warrants to purchase 790,410 shares of common stock were repriced at $2.70 and warrants to purchase 506,627 shares of common stock were repriced at $1.65. The Company received $3.0 million in gross proceeds from the sale of these repriced warrants.

Quarterly Conference Call

The Company is hosting a conference call to provide a business update and discuss its third quarter 2018 financial results at 11:00 a.m. EST on Thursday November 15, 2018. To participate in the call, interested parties may dial 1-877-260-1479 (Toll-Free/North America) or +1-334-323-0522 (International/Toll) and ask for the Celsion Corporation Third Quarter 2018 Earnings Call (Conference Code: 6704591). Listeners are encouraged to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com.

The call will be archived for replay on Thursday, November 15, 2018 and will remain available until Thursday November 29, 2018. The replay can be accessed at 1-888-203-1112 (Toll-Free/USA) or +1-719-457-0820 (International/Toll) using Conference ID: 6704591. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. EST on Thursday, November 15, 2018

Cytori Reports Q3 2018 Business and Financial Results

On November 14, 2018 Cytori Therapeutics (NASDAQ: CYTX) ("Cytori" or the "Company") reported Q3 2018 financial results and provided updates on corporate activities (Press release, Cytori Therapeutics, NOV 14, 2018, View Source [SID1234531481]).

Q3 2018 net loss was $2.3 million, or $0.27 per share. Operating cash burn for Q3 was approximately $2.6 million. Cytori ended Q3 with approximately $6.8 million of cash and cash equivalents.

Cytori is developing its lead chemotherapy drug, ATI-0918, a generic version of pegylated liposomal doxorubicin hydrochloride, with the goal of submitting a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) next year. We previously completed a bioequivalence study against the European reference drug and are in the process of completing manufacturing-related activities to support the MAA. The Company also continues to evaluate potential commercial partnering opportunities for ATI-0918 with a focus on Europe, which has a current estimated market size of over $120 million.

Cytori is also developing another chemotherapy drug, ATI-1123, a patented, albumin-stabilized pegylated liposomal docetaxel. The Company recently received an orphan drug designation from the U.S. FDA for small cell lung cancer and intends to pursue FDA’s 505(b)(2) new drug application (NDA) pathway in the U.S. which may offer accelerated and lower cost development.

In the first half of 2019, Cytori expects a 1-year data readout from the 45 patient, multi-center, potential pivotal clinical trial in stress urinary incontinence conducted in Japan called ADRESU.

Later in 2018, Cytori expects a 6-month data readout from the 40 patient, French SCLERADEC II clinical trial in scleroderma patients.

Cytori is actively conducting the U.S. Phase I RELIEF trial in thermal burn injury trial sponsored by BARDA. Cytori completed a successful In-Process Review meeting with BARDA this past June.

Commercially, Cytori is focusing its efforts in Japan and continues to see favorable growth trends in the use of its cell therapy products approved under the Regenerative Medicine Law in the aesthetic and orthopedic markets. The Company remains on track to see continued double digit year-over-year growth in Celution System consumable utilization.

Finally, Cytori recently received the first $1.0 million royalty milestone from Bimini Technologies, LLC (Bimini). In 2013, Cytori divested the Puregraft product line that includes periodic royalty payments of up to $10.0 million and certain other economic benefits based on Bimini achieving gross profits milestones.

"A key corporate objective is to complete manufacturing support activities and seek European marketing authorization for ATI-0918, our lead oncology drug product. Furthermore, we have recently expanded development activities for the ATI-1123 phase II oncology program and its potential 505(b)(2) acceptability," said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. "In cell therapy, we are focused on continued revenue growth based on positive quarter-over-quarter and year-over-year consumable utilization trends. In the meantime, we are awaiting pivotal clinical data from our Japanese stress urinary incontinence trial."

Q3 2018 and year-to-date Financial Performance

Q3 2018 and year-to-date operating cash burn was $2.6 million and $9.5 million, compared to $4.0 million and $13.9 million for the same periods in 2017, respectively.
Q3 2018 and year-to-date product revenues were $0.9 million and $2.2 million, compared to $0.5 million and $2.0 million for the same periods in 2017, respectively.
Q3 2018 and year-to-date contract revenues were $0.5 million and $2.3 million, compared to $1.3 million and $2.9 million for the same periods in 2017, respectively.
Q3 2018 and year-to-date consumable utilization in Japan grew by approximate 90% and 70%, when comparing to the same periods in 2017, respectively.
Cash and debt principal balances at September 30, 2018 were approximately $6.8 million and $13.0 million, respectively.
Q3 2018 adjusted net loss was $4.0 million or $0.45 per share, compared to a net loss of $4.8 million or $1.39 per share for the same period in 2017. The adjusted net loss excludes a non-cash beneficial conversion feature (a non gaap measure) related to the issuance of our Series C convertible preferred shares in the third quarter of 2018 of $2.5 million, as well as a credit of $1.7 million related to a change in fair value of warrant liability (a non gaap measure). Q3 2018 net loss allocable to common stockholders was $4.8 million, or $0.55 per share.
Year-to-date 2018 adjusted net loss was $12.1 million or $1.73 per share, compared to $18.4 million or $6.22 per share for the same period in 2017. The adjusted net loss excludes a non-cash beneficial conversion feature (a non gaap measure) related to the issuance of our Series C convertible preferred shares in the third quarter of 2018 of $2.5 million, as well as a credit of $1.7 million related to a change in fair value of warrant liability (a non gaap measure). Year-to-date 2018 net loss allocable to common stockholders was $12.9 million, or $1.85 per share.
Selected Key Anticipated Milestones:

Complete ATI-0918 development and manufacturing required to prepare and file a MAA with the EMA.
Seek FDA 505(b)(2) pathway applicability for ATI-1123 product.
Obtain Japan MHLW Class III approval for Celution System consumables.
Report 1-year Japanese ADRESU pivotal clinical trial data for post-surgical male stress urinary incontinence.
Enrollment update in the BARDA-funded U.S. RELIEF clinical trial.
Report French investigator initiated SCLERADEC II clinical trial data in scleroderma hand dysfunction.
Management Conference Call Webcast

Cytori will host a management conference call at 5:30 p.m. Eastern Time today to further discuss its progress. The webcast will be available live and by replay two hours after the call and may be accessed under "Webcasts" in the Investor Relations section of Cytori’s website. If you are unable to access the webcast, you may dial in to the call at +1.877.402.3914, Conference ID: 9699923.

Rexahn Pharmaceuticals Announces Leadership Transition

On November 14, 2018 Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage biopharmaceutical company developing innovative therapies to improve outcomes in cancers that are difficult to treat, reported that Douglas J. Swirsky, who has served as Rexahn’s president and chief financial officer since January 2018, has been named the company’s president and chief executive officer and appointed to the company’s board of directors effective immediately (Press release, Rexahn, NOV 14, 2018, View Source [SID1234531477]). Peter D. Suzdak, Ph.D., chief executive officer, has departed the company and resigned as a member of its board of directors.

"On behalf of the board and everyone at Rexahn, I want to thank Peter Suzdak for his contributions to the company over the past six years," said Peter Brandt, chairman of the board of directors. "The board is confident that Doug has the experience and creativity to deliver on the promise of Rexahn’s innovative pipeline and lead the company forward through substantial value-creating milestones."

"I am excited about the future of Rexahn and believe significant opportunities exist to transform Rexahn into an industry-leading, cancer-focused company. I look forward to working with the board, the executive team and all stakeholders to achieve this goal," said Mr. Swirsky.

Prior to joining Rexahn, Mr. Swirsky was CEO and a director of GenVec, Inc., a publicly traded biotechnology company, a position he held from 2013 through the sale of the company in 2017. He also served as GenVec’s CFO from 2006 until he assumed the role of CEO in 2013. Prior to joining GenVec, Mr. Swirsky was a managing director and the head of life sciences investment banking at Stifel Nicolaus from 2005 to 2006 and held investment banking positions at Legg Mason from 2002 until Stifel Financial’s acquisition of the Legg Mason Capital Markets business in 2005. He has also previously held investment banking positions at UBS, PaineWebber and Morgan Stanley. Mr. Swirsky currently serves on the board of directors of Fibrocell Science, Inc., Cellectar Biosciences, Inc. and Pernix Therapeutics Holdings, Inc. He is a certified public accountant and a CFA charter holder. He received his B.S. in Business Administration from Boston University and his M.B.A. from the Kellogg School of Management at Northwestern University.

Mr. Swirsky will also continue to serve as the company’s principal financial officer.

Janssen seeks expanded use of IMBRUVICA®? (ibrutinib) in two indications in Europe

On November 14, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of two Type II variation applications to the European Medicines Agency (EMA) seeking approval for the expanded use of IMBRUVICA (ibrutinib) (Press release, Johnson & Johnson, NOV 14, 2018, View Source [SID1234531468]). One application seeks to include use of ibrutinib in combination with obinutuzumab in previously untreated adults with chronic lymphocytic leukaemia (CLL) and to add long-term follow-up data from the existing label studies RESONATETM (PCYC-1112) and RESONATETM-2 (PCYC-1115). The second is for use of ibrutinib plus rituximab for the treatment of previously untreated and relapsed/refractory adults with Waldenström’s macroglobulinemia (WM).

"Today’s news brings us one step closer to potentially offering ibrutinib in new combinations for patients where unmet needs still persist," said Dr. Catherine Taylor, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. "Ibrutinib continues to demonstrate clinical benefit over the long term for a broad
group of patients living with blood cancer, and we look forward to working with relevant authorities to secure approval of these new combinations."

Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company. The CLL submission is supported by positive results from the Phase 3 iLLUMINATE (PCYC1130) study which investigated ibrutinib in combination with obinutuzumab versus
chlorambucil plus obinutuzumab in patients with newly diagnosed CLL.

1 Study findings from iLLUMINATE will also be featured as an oral presentation (abstract #691), whilst further analysis of RESONATETM and RESONATETM-2 results in comparison with real-world evidence databases (abstract #4427) will be included at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place in San Diego next month.1,2 A supplemental New Drug Application (sNDA) which was also recently submitted to the U.S. Food and Drug Administration (FDA) received Priority Review.

2 In WM, the submission is supported by data from the Phase 3 iNNOVATE (PCYC-1127) study evaluating ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.

3 Follow-up efficacy and safety findings from the iNNOVATE study will also be presented at ASH (Free ASH Whitepaper) 2018 (abstract
#149).

4 In August 2018, the FDA approved ibrutinib in combination with rituximab for the treatment of WM based on the data from iNNOVATE.

5 Additional information about both studies can be found at www.ClinicalTrials.gov (NCT02264574 and NCT02165397).
6,7
#ENDS#

About ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.8 By blocking this BTK protein, ibrutinib helps kill and reduce the number of cancer cells, thereby delaying progression of the cancer.9 Ibrutinib is currently approved in Europe for the following uses:10

 Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.

 Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell MCL.

 Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemoimmunotherapy.

The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.10

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About CLL
CLL is typically a slow-growing blood cancer of the white blood cells.11 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year with rates amongst men and women approximately 5.87 and 4.01 cases per 100,000 persons per year, respectively.

12 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.13
CLL is a chronic disease; median overall survival ranges between 18 months and more than 10 years, according to the stage of disease.14 The disease eventually progresses in the majority of patients, and patients are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.
3
About Waldenström’s macroglobulinemia
Waldenström’s macroglobulinemia (WM) is a rare form of non-Hodgkin’s lymphoma (NHL).15 It causes overproduction of a protein called monoclonal immunoglobulin M (IgM) antibody, which causes a thickening of the blood.
16 Incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.17 The causes of WM are unknown, with it typically affecting older adults and being slightly more
common in men than women.15,17

ARCA BIOPHARMA ANNOUNCES THIRD QUARTER 2018 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

On November 14, 2018 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, reported financial results for the quarter ended September 30, 2018 and provided a corporate update (Press release, Arca biopharma, NOV 14, 2018, View Source [SID1234531458]).

"We remain focused on advancing the development of our pipeline of genetically-targeted therapeutics to address the unmet medical needs of patients with cardiovascular disease," commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. "FDA is currently giving further consideration to our SPA application for the Phase 3 clinical trial of Gencaro following our provision of supporting information in response to an initial No Agreement letter. We have requested a meeting with the FDA and look forward to meeting with them in December to discuss any remaining issues in the application."

Pipeline Update

GencaroTM (bucindolol hydrochloride) – a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically-targeted treatment for heart failure (HF) patients at risk for atrial fibrillation (AF).

At the end of October, the Company received a No Agreement letter from the U.S. Food and Drug Administration (FDA) on its Special Protocol Assessment (SPA) application for the Phase 3 PRECISION-AF clinical trial. After further correspondence with the FDA and the provision of information supporting the SPA application, the FDA has agreed to reconsider the SPA request. ARCA has requested a meeting with the FDA to review the SPA application, which the Company anticipates will occur in December.
AB171 – a thiol-substituted isosorbide mononitrate being developed as a potential genetically-targeted treatment for heart failure (HF) and peripheral arterial disease (PAD).

Chemistry, manufacturing and controls (CMC) activities were continued in the third quarter.
IND-enabling non-clinical studies are anticipated to begin in the first half of 2019.
Third Quarter 2018 Summary Financial Results

Cash, cash equivalents and marketable securities totaled $8.1 million as of September 30, 2018, compared to $11.8 million as of December 31, 2017. ARCA believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations, at its projected cost structure, through the end of the first quarter of 2019.

Research and development (R&D) expenses for the quarter ended September 30, 2018 totaled $0.7 million compared to $3.5 million for the corresponding period of 2017. The $2.7 million decrease in R&D expenses in the third quarter of 2018 as compared to the third quarter 2017 was primarily due to decreased clinical expenses following the completion of the GENETIC-AF clinical trial. The Company expects R&D expenses in 2018 to be lower than 2017 as the GENETIC-AF clinical trial has been completed.

General and administrative (G&A) expenses for the quarter ended September 30, 2018 were $0.9 million, relatively unchanged compared to the $1.0 million in the third quarter of 2017. ARCA expects G&A expenses in 2018 to be consistent with those in 2017 as it maintains administrative activities to support ongoing operations.

Total operating expenses for the quarter ended September 30, 2018 were $1.7 million compared to $4.5 million for the third quarter of 2017. The decrease in total operating expenses for the second quarter of 2018 was primarily due to the decrease in R&D expense due to the completion of the GENETIC-AF clinical trial.

Net loss was $1.6 million, or $0.11 per share, for the third quarter of 2018 compared to $4.4 million, or $0.39 per share, for the third quarter of 2017.