On November 14, 2018 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic or the Corporation) reported today its unaudited financial results for the third quarter ended September 30, 2018 (Press release, ProMetic Life Sciences, NOV 14, 2018, View Source [SID1234531350]).

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"Several initiatives that we have been pursuing during the past quarter should bear fruit in the coming weeks and months," said Pierre Laurin, Prometic’s President and Chief Executive Officer. "We have implemented cost-control measures to reduce our cash use while at the same time have made significant progress to advance our two lead drug candidates, Ryplazim (plasminogen) and PBI-4050. As previously stated, our current business plan calls for a significant reduction in R&D expenditures of up to $30 million in 2019 as compared to this year’s budget. Our primary objective remains to close the gap between the fundamental enterprise value we have built and our current market valuation by strengthening our financial position through the closing of commercial partnerships and equity-related initiatives."

Commenting on the third quarter 2018 financial results, Bruce Pritchard, Prometic’s Chief Operating Officer and Chief Financial Officer, said, "We are ahead of target with the financial guidance provided during the AGM in May 2018 and our last few conference calls. We have effectively implemented cost control measures as evidenced by the trending quarterly decrease in R&D, Administration and Sales & Marketing expenses as well as decreases in net loss and cash flows used in operating activities. Cash used in operations year-to-date was $57 M compared to $95 M for the same period in 2017".

Small Molecule Therapeutics Highlights

PBI-4050 – Received a Rare Pediatric Disease designation from the US Food and Drug Administration for the treatment of Alström syndrome
PBI-4050 – Published a paper further elucidating the mechanism of action of its lead drug candidate, PBI-4050, on liver fibrosis in the Journal of Pharmacology and Experimental Therapeutics. The paper entitled "PBI-4050 reduces stellate cell activation and liver fibrosis through modulation of intracellular ATP levels and LKB1-AMPK-mTOR pathway" details the antifibrotic signaling pathway modulated by PBI-4050.
PBI-4050 – Hosted a Key Opinion Leader meeting in New York on PBI-4050 as a novel treatment for Alström syndrome and non-alcoholic steatohepatitis (NASH).
Plasma-Derived Therapeutics Highlights

RyplazimTM (Plasminogen) – Completed a Type C meeting in which the FDA agreed with the Company’s proposed action plan for the implementation of additional analytical assays and in-process controls related to the RyplazimTM (plasminogen) manufacturing process. As a result of the feedback received during the Type C meeting, Prometic is finalizing the process performance qualification (PPQ) protocols in anticipation of commencing the manufacturing of additional RyplazimTM (plasminogen) conformance lots.

Subsequent Events to Third Quarter 2018

Closed a deal with Structured Alpha LP (SALP), an affiliate of Thomvest Asset Management Inc., to extend the maturity dates of the USD $80 million (CAD $100 million) line of credit and the Original Issue Discount Notes to September 2024.
2018 Third Quarter Financial Results

Revenues
Total revenues for the third quarter ended September 30, 2018 were $12.3 million and $36.8 million for the nine months ended September 30, 2018. Revenues from the sale of goods, representing most of the 2018 revenues to date, were $35.3 million during the first nine months ended September 30, 2018 compared to $11 million during the corresponding 2017 period. The $24.3 million increase for 2018 is mainly due to $19.7 million in sales of normal source plasma which occurred in the second and third quarters of 2018 following a change in the production forecast due to the delay of the BLA approval for RyplazimTM (plasminogen). The remainder of the increase of $4.6 million for the nine month period is due to an increase in third party sales in the bioseparation segment. 2018 bioseparation sales are expected to exceed $21 million, which would represent a 30% increase compared to 2017 bioseparation revenues. A comparable level of revenue growth for 2019 is anticipated and is mainly due to the expansion of manufacturing activities by existing clients who utilize Prometic’s products in their production processes, the adoption of products by new clients, the introduction of new products and the continuing expansion of the market for bioseparation products.

Cost of sales and other production expenses
Cost of sales and other production expenses were $9.2 million for the third quarter ended September 30, 2018 compared to $3.8 million for the corresponding period in 2017, representing an increase of $5.5 million. Cost of sales and other production expenses were $30.4 million during the nine months ended September 30, 2018 compared to $7.7 million for the corresponding period in 2017, representing an increase of $22.7 million. The increase was due primarily to the cost of the plasma inventory sold.

Research and Development (R&D)
Total R&D expenses were $24.1 million for the third quarter ended September 30, 2018 compared to $23.3 million for the third quarter ended September 30, 2017. Total R&D expenses were $70.5 million for the nine months ended September 30, 2018 compared to $72.2 million for the corresponding period in 2017, representing a decrease of $1.7 million. The completion of the pivotal phase 3 clinical programs for IVIG and for Ryplazim (plasminogen) and termination of non core preclinical and clinical programs will translate into a significant R&D cost reduction in 2019 compared to 2018.

Administration, Sales & Marketing
Administration, selling and marketing expenses were $6.2 million for the third quarter ended September 30, 2018 compared to $7.7 million for the third quarter ended September 30, 2017. The $1.4 million decrease was due to a reduction in consulting fees and employee compensation expenses. Administration, selling and marketing expenses declined slightly at $20.9 million during the nine months ended September 30, 2018 compared to $22.7 million for the corresponding period in 2017.

Finance Costs
Finance costs were $5.9 million for the third quarter ended September 30, 2018 compared to $2.1 million during the corresponding period of 2017, representing an increase of $3.8 million. Finance costs were $15.5 million for the nine months ended September 30, 2018 compared to $5.3 million during the corresponding period of 2017, representing an increase of $10.2 million. This increase reflects higher debt levels during the nine months ended September 30, 2018 compared to the same period of 2017.

Net Loss
Prometic incurred a net loss of $28.9 million for the third quarter ended September 30, 2018 compared to a net loss of $17.8 million for the third quarter ended September 30, 2017. Prometic incurred a net loss of $96.6 million for the nine months ended September 30, 2018 compared to a net loss of $78.4 million for the corresponding period of 2017. The main reason for the increase in the net loss is that the results for the quarter and the nine months ending September 30, 2017 included $19.7 million in milestone and licensing revenues related to the licensing agreement signed with Jiangsu Renshou Pharmaceutical Co, Ltd.

With the delay of the anticipated launch of its most advanced product, RyplazimTM (plasminogen), the Corporation had to finance its R&D activities via various sources. To date, the Corporation has financed its activities through the sale of products in the bioseparations segment, collaboration arrangements and licensing arrangements, the issuance of debt and equity, operational restructuring as well as investment tax credits. Prometic is currently actively involved in negotiating both equity and equity-linked financing initiatives and continues to be in dialogue with potential licensing partners. Although the Corporation believes that it will be able to obtain the necessary funding as in the past, there can be no assurance of the success of these plans.

Conference Call Information

Prometic will host a conference call at 11:00 am (ET) on Thursday November 15, 2018. The telephone numbers to access the conference call are (647) 427-7450 and 1-888-231-8191 (toll-free). A replay of the call will be available as of Thursday November 15, 2018 at 2:00 pm. The numbers to access the replay are 1-416-849-0833 and 1-855-859-2056 (passcode: 1190238). A live audio webcast of the conference call, with slides, will be available through the following: View Source

Additional Information in Respect to the Third Quarter Ended September 30, 2018

Prometic’s MD&A and condensed interim consolidated financial statements for the quarter ended September 30, 2018 will be filed on SEDAR (View Source) and will be available on the Company’s website at www.prometic.com.

On November 14, 2018 ArQule, Inc. (Nasdaq: ARQL) reported that Paolo Pucci, Chief Executive Officer, and Marc Schegerin, Senior Vice President, Head of Strategy, Finance, and Communication will present at the 30th Annual Piper Jaffray Healthcare Conference on November 28, 2018, at 1:50pm ET at the Lotte New York Palace in New York City (Press release, ArQule, NOV 14, 2018, View Source [SID1234531291]).

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The live webcast of the presentation will be available via the "Investors & Media" section of ArQule’s website, www.arqule.com, under "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation.

On November 14, 2018 Mateon Therapeutics, Inc. (OTCQB:MATN), a biopharmaceutical company developing investigational drugs for the treatment of orphan oncology indications, reported third quarter 2018 financial results (Press release, Mateon Therapeutics, NOV 14, 2018, View Source [SID1234531307]).

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For the three months ended September 30, 2018, Mateon reported a net loss of $0.7 million, compared to a net loss of $3.5 million reported for the three months ended September 30, 2017. As of September 30, 2018, Mateon had cash of $1.1 million.

"We are inching closer to finalizing our regulatory submission for a new clinical phase 2a study of CA4P combined with the checkpoint inhibitor anti-PD1 in patients with advanced melanoma. I believe that our scientific approach for increasing the anti-tumor immunity of checkpoint inhibitors by inducing ischemic necrosis of tumor cells with CA4P is as good as any of the other checkpoint inhibitor approaches, although it is certainly less well-recognized," stated William D. Schwieterman, M.D., Chief Executive Officer of Mateon Therapeutics. "In addition, we are continuing to screen patients for enrollment into our study of OXi4503 for relapsed/refractory acute myeloid leukemia and myelodysplastic syndromes. Our target is a total of approximately ten patients at the 9.76 mg/m2 dose currently being evaluated."

Suzhou’s CStone Pharma has filed for a Hong Kong IPO. Founded in 2015, CStone has quickly built a portfolio of 14 oncology candidates. The company says its three core products are IO drugs — PD-1, PD-L1 and CTLA-4 antibodies — which will be paired with other of its assets to offer combination therapies. As part of its development, CStone has in-licensed molecularly targeted compounds from Agios (a $424 million deal) and Blueprint (a $386 million, three-drug agreement), which CStone will develop in greater China.

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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