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News Article | May 12, 2017
Site: www.marketwired.com

RESEARCH TRIANGLE PARK, NORTH CAROLINA--(Marketwired - May 12, 2017) - Fennec Pharmaceuticals Inc. (TSX:FRX)(OTCQB:FENCF), a specialty pharmaceutical company focused on the development of Sodium Thiosulfate (STS) for the prevention of platinum-induced ototoxicity in pediatric patients, today reported its corporate update and financial results for the first quarter ended March 31, 2017. "Our highest priority remains the preparation for NDA/MAA submissions pending favorable SIOPEL 6 hearing results in October this year," said Rosty Raykov, CEO of Fennec. "I am very pleased that the team continues to execute on our internal plan." The selected financial data presented below is derived from our audited condensed consolidated financial statements which were prepared in accordance with U.S. generally accepted accounting principles. The complete interim unaudited consolidated financial statements for the period ended March 31, 2017 and management's discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com. All values are presented in thousands unless otherwise noted. Research and development expenses for the three months ended March 31, 2017 were $0.2 million above the same period in the prior year. This increase relates primarily to drug manufacturing activities and preparations for registration batches upon release of the SIOPEL 6 results expected in late 2017. General and administrative expenses increased over the same period in 2016 by $0.1 million. There were increases in director and key employee compensation during the quarter ended March 31, 2017 over same quarter in 2016 as the Company made efforts to align our director and key employee compensations to that of companies of similar market capitalizations in similar industries. Travel and regulatory consulting also increased during the quarter ended March 31, 2017 over the same period in 2016 as the company prepares for trial results expected in late 2017. During the quarter ended March 31, 2017, there were also increases in non-cash equity compensation expenses for employees and contractors as compared with the same period in 2016. The Company recorded an unrealized loss on derivatives of $37 in the three months ended March 31, 2017 compared to the same three months ended in 2016 where there was an unrealized gain of $43. The change results from derivative liabilities on the balance sheet and is associated with a small amount of Canadian dollar denominated options. These option derivatives have been recorded at their fair value as a liability at issuance and will continue to be re-measured at fair value as a liability at each subsequent balance sheet date. Any change in value between reporting periods will be recorded as an unrealized gain/(loss). These options will continue to be reported as a liability until such time as they are exercised or expire. The fair value of these options is estimated using the Black-Scholes option-pricing model. Cash and cash equivalents were $3,251 at March 31, 2017 and $3,926 at December 31, 2016. The decrease in cash and cash equivalents between March 31, 2017 and December 31, 2016 relates completely to cash spent on research and development and general and administrative activities. At March 31, 2017, the Company had working capital balance totaling approximately $2.9 million compared to $3.6 million as of December 31, 2016. Net cash used in operating activities for the three months ended March 31, 2017 was $675, as compared to $499 during the same period in 2016. This increase in cash outlays relates to ongoing STS Phase III trials and STS product development. There was no cash provided by financing activities for the three months ended March 31, 2017 compared to $102 for the three months ended March 31, 2016. Total decrease in cash and cash equivalents was $675 for the three months ended March 31, 2017 as opposed to a decrease of $397 over the same period in 2016. Except for historical information described in this press release, all other statements are forward-looking. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company's business that could cause actual results to vary, including such risks that regulatory and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company's products will not be as large as expected, the Company's products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital requirements in different countries and municipalities, the proposed sale to Elion may not be completed and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2016. Fennec Pharmaceuticals, Inc. disclaims any obligation to update these forward-looking statements except as required by law. For a more detailed discussion of related risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com. Cisplatin and other platinum compounds are essential chemotherapeutic components for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity in many patients, and are particularly harmful to the survivors of pediatric cancer. In the U.S. and Europe there is estimated that over 10,000 children are diagnosed with local cancers that may receive platinum based chemotherapy. Localized cancers that receive platinum agents may have overall survival rates of greater than 80% further emphasizing the quality of life after treatment. The incidence of hearing loss in these children depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement. STS has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies are closed to recruitment. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors. Fennec Pharmaceuticals, Inc., is a specialty pharmaceutical company focused on the development of Sodium Thiosulfate (STS) for the prevention of platinum-induced ototoxicity in pediatric patients. STS has received Orphan Drug Designation in the US in this setting. For more information, please visit www.fennecpharma.com.


News Article | May 10, 2017
Site: www.prnewswire.com

"Finally, we look forward to presenting the more detailed and updated global Phase 3 STS results to the medical community at the upcoming 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.  This Phase 3 trial, along with the combination trial of aldoxorubicin with ifosfamide/mesna, continue to build upon the body of clinical data supporting aldoxorubicin's potential as a new and better treatment for patients with STS," Mr. Kriegsman commented. Strengthened the Balance Sheet with $15 Million in Financing and $2 Million in Warrant Proceeds.  In early May 2017, CytRx completed the sale of approximately 30 million shares of common stock in a public offering at a price of $0.50 per share, resulting in net proceeds to the Company of approximately $13.9 million after deducting placement agent's fees and other estimated offering expenses.  Additionally, the Company received approximately $1.9 million from the exercise of warrants resulting in a total raise of $15.8 million subsequent to March 31, 2017. Concluded Phase 3 Trial Evaluating Aldoxorubicin in Relapsed or Refractory STS.  Based on its goal to submit a rolling NDA, subject to approval from the FDA, the Company has concluded its Phase 3 study evaluating aldoxorubicin compared to investigator's choice in patients with relapsed or refractory STS. Aldoxorubicin Clinical Trial Data in Patients with STS Selected for Oral Presentation at the 2017 American Society of Clinical Oncology Annual Meeting (ASCO).  In April 2017, CytRx announced that an abstract describing results from its global Phase 3 clinical trial evaluating aldoxorubicin versus investigators' choice in patients with relapsed and refractory STS was selected for an oral presentation at ASCO 2017, taking place June 2-6, 2017 in Chicago.  The oral presentation (abstract #11000) will be given by Principal Investigator, Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, on Friday, June 2, 2017 between 3:00-6:00 pm CT.  In addition to the STS presentation, a poster (abstract #11051) highlighting updated data from CytRx's ongoing Phase 1/2 clinical trial combining aldoxorubicin with ifosfamide/mesna in patients with first-line soft tissue sarcomas will also be presented by Frederick C. Eilber, M.D., Director of the UCLA Sarcoma Translational Research Program within the Jonsson Comprehensive Cancer Center, on Sunday, June 4, 2017 between 8:00-11:00 am CT. Announced FDA Agreement on Regulatory Pathway to Approval for Aldoxorubicin in STS.  In April 2017, CytRx announced that it had reached an agreement with the FDA on the pathway for a NDA submission for aldoxorubicin as a treatment for STS.  The Company's goal is to submit a rolling NDA under section 505(b)(2) to the FDA in the fourth quarter of 2017.  The commercial launch of aldoxorubicin is projected for 2018 in the U.S.  Aldoxorubicin has received Orphan Drug Designation from the FDA for the treatment of STS, which provides for several benefits including seven years of market exclusivity after approval, certain R&D related tax credits and protocol assistance from the FDA.  CytRx also plans to discuss with the European Medicines Agency a path to filing a Marketing Authorization Application.  European regulators granted aldoxorubicin Orphan Medicinal Product Designation for STS which confers ten years of market exclusivity among other benefits. On May 2, 2017, CytRx completed a public offering of 30 million shares of its common stock at a price of $0.50 per share.  The net proceeds to CytRx from the offering, after deducting placement agent's fees and other estimated offering expenses, were approximately $13.9 million.  In addition, CytRx received $1.9 million in proceeds from the exercise of warrants in April and May 2017. Net loss for the quarter ended March 31, 2017, was $11.0 million, or $(0.10) per share, compared with a net loss of $12.6 million, or $(0.19) per share, for the quarter ended March 31, 2016.  During the first quarter of 2017, the Company recognized a non-cash loss of $0.03 million on the fair value adjustment of warrant derivative liability related to warrants issued in 2016, compared to a non-cash loss of $0.2 million during the first quarter of 2016 related to now expired warrants. Research and development (R&D) expenses were $6.8 million for the first quarter of 2017, and included development expenses of $4.0 million for aldoxorubicin, approximately $0.6 million for pre-clinical development of new albumin-binding, ultra-high potency cancer drugs (German lab), and approximately $2.2 million for general operation of our clinical programs.  R&D expenses were $8.2 million for the first quarter of 2016. General and administrative (G&A) expenses were $3.0 million for the first quarter of 2017, compared with $4.0 million for the first quarter of 2016. CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin, its improved version of the widely used chemotherapeutic agent doxorubicin.  CytRx is also expanding its pipeline of oncology candidates at its laboratory facilities in Freiburg, Germany, through its LADR™ (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx's expertise in albumin biology and linker technology for the development of a new class of anti-cancer therapies. This press release contains forward-looking statements. Such statements are not promises or guarantees, and involve numerous risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements.  These risks include: the timing and final results of CytRx's clinical testing of aldoxorubicin; timing of CytRx's preparation and submission of an NDA for aldoxorubicin for the treatment of STS and FDA acceptance and review of any NDA; the risk that CytRx may be unsuccessful in obtaining FDA approval or, if approval is obtained, in commercializing aldoxorubicin in the United States or elsewhere; risks related to CytRx's need for and ability to raise additional capital or enter into strategic partnerships to fund its ongoing working capital needs and development efforts; risks related to CytRx's ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements; risks relating to preclinical testing of CytRx's LADR™ linker technology platform; risks related to pending lawsuits against CytRx and its officers and directors; and the other risks and uncertainties described in CytRx's Annual Report on Form 10-K for the year ended December 31, 2016 filed with the Securities and Exchange Commission. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cytrx-reports-first-quarter-2017-financial-results-300455045.html


A detection and indication system for use in a railway switch machine which utilizes one or more roller members which physically interact with a point detector bar coupled to one or more switch points to provide an indication of a point failure upon movement of the point detector bar a predetermined distance from an initial position. The system includes a mounting structure structured to be coupled to a housing of the switch machine and a first sensing device coupled to the mounting structure. The first sensing device is positioned and structured to detect movement of the point detector bar a second predetermined distance from the initial position, wherein the second predetermined distance is less than the first predetermined distance.


RESEARCH TRIANGLE PARK, NORTH CAROLINA--(Marketwired - June 8, 2017) - Fennec Pharmaceuticals Inc. (TSX:FRX)(OTCQB:FENCF) (the "Company" or "Fennec"), a specialty pharmaceutical company focused on the development of Sodium Thiosulfate (STS) for the prevention of platinum-induced chemotherapy ototoxicity in pediatric patients, announced today that it has completed a non-brokered private placement (the "Offering") of 1,900,000 common shares for gross proceeds of US$7,600,000. The common shares of the Company (the "Shares") were issued at a price of US$4.00 per Share. The current number of outstanding Shares prior to giving effect to the Offering, was 13,707,306. "We are very pleased to announce this important financing as we prepare for the regulatory submissions of STS pending favorable SIOPEL 6 hearing results in October this year," said Rosty Raykov, CEO of Fennec. "The investment and support received by both existing and new investors, including venBio Select Advisor, significantly strengthens the Company's balance sheet and further validates the potential benefit STS can have for pediatric cancer patients." The issue price of the Shares represents approximately a 2% discount on the market price of the Shares on the date of a binding agreement, as defined by the Toronto Stock Exchange. For Canadian securities law purposes, the Shares issued in the Offering are subject to a hold period, which will expire four months plus one day from the date of closing. For United States securities law purposes, the Shares issued in the Offering have not been registered under the Securities Act of 1933, as amended (the "1933 Act"), and may not be offered or sold in the United States absent registration under the 1933 Act or an applicable exemption from the registration requirements of the 1933 Act. It is anticipated that the net proceeds of the Offering will be used by the Company for the development of STS and general working capital purposes. In connection with the Offering, Essetifin SpA, which owned 2,631,579 Shares prior to completion of the Offering (representing 19.2% of Fennec's issued and outstanding Shares prior to giving effect to the Offering) purchased an additional 300,000 Shares. Following the Offering, Essetifin SpA owns 2,931,579 Shares (representing 21.4% of Fennec's issued and outstanding Shares after giving effect to the Offering and 18.8% of Fennec's issued and outstanding Shares upon issuance having regard to the Offering). In connection with its Share ownership, Essetifin SpA may be deemed under the Securities Act (Ontario) to be an associated entity of Fennec. Such participation by Essetifin SpA may be considered a "related party transaction", as defined under Multilateral Instrument 61-101 ("MI 61-101"). The transaction will be exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 as neither the fair market value of any units issued to or the consideration paid by such entity will exceed 25% of the Company's market capitalization. A material change report in respect of the transaction was not filed 21 days in advance of the expected closing of the Offering. The shorter period was necessary in order to permit the Company to close the Offering in a timeframe consistent with usual market practice for transactions of this nature. The number of Shares issued in connection with the Offering is 1,900,000 Shares, which represents 13.9% of Fennec's issued and outstanding Shares prior to giving effect to the Offering. The Offering has been negotiated at arm's length and will not affect control of the Company. Cisplatin and other platinum compounds are essential chemotherapeutic components for many pediatric malignancies. Unfortunately, platinum-based therapies cause hearing loss or ototoxicity in many patients, and are particularly harmful to the survivors of pediatric cancer. In the U.S. and Europe there is estimated that 7,000 children are diagnosed with local cancers that may receive platinum based chemotherapy. Localized cancers have overall survival rates of greater than 80%, further emphasizing the importance of quality of life after treatment. The incidence of hearing loss in these children depends upon the dose and duration of chemotherapy, but it affects at least 60% of the patients. Many of these children require lifelong hearing aids and technically difficult and sub-optimal cochlear (inner ear) implants that have been shown to provide some marginal benefit. Post platinum exposure, infants and young children at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement. STS has been studied by cooperative groups in two Phase 3 clinical studies of reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies are closed to recruitment. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors. Fennec Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development of Sodium Thiosulfate (STS) for the prevention of platinum-induced chemotherapy ototoxicity in pediatric patients. STS has received Orphan Drug Designation in the US in this setting. For more information, please visit www.fennecpharma.com. Except for historical information described in this press release, all other statements are forward-looking, including statements or assumptions about the anticipated use of proceeds and any other statements regarding the Company's objectives (and strategies to achieve such objectives), future expectations, beliefs, goals or prospects. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company's business that could cause actual results to vary, including such risks relating to the anticipated use and sufficiency of the proceeds of the Offering: risks that a material adverse change occurs in respect of the Company; that regulatory and guideline developments may change; that scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals; that clinical results may not be replicated in actual patient settings; that protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by its competitors; that the available market for the Company's products will not be as large as expected; that the Company's products will not be able to penetrate one or more targeted markets; that revenues will not be sufficient to fund further development and clinical studies; that the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2016. Fennec Pharmaceuticals Inc. disclaims any obligation to update these forward-looking statements except as required by law. For a more detailed discussion of related risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com.


Patent
STS Inc | Date: 2011-07-29

An embodiment of a power supply includes an input node, a converter stage, and an outlet. The input node is operable to receive an input AC signal having peak portions and non-peak portions. The converter stage is operable to generate a DC power signal from the input AC signal and to cause a first current to be drawn from the input node during at least the non-peak portions of the input AC signal. And the outlet is operable to carry the DC power signal. For example, such a power supply may be installed in a facility such as a residence, office building, or manufacturing plant, or the facilitys existing power supply may be retrofitted, to provide one or more power outlets that each carry a respective power-factor-corrected (PFC) DC voltage. Because the outlet voltages are PFC voltages, the amount of wasted power dissipated in the facility power lines/wiring and in the main power lines from the power company may be significantly reduced, without requiring each piece of equipment (e.g., an appliance, machinery) that is wired/plugged into the outlets to have an onboard PFC. This savings in wasted power may provide a significant cost savings to both the facility owner (e.g., lower electric bill) and the power company (e.g., lower power-generation and grid costs), and the ability to use equipment lacking onboard PFCs may reduce the purchase price of the equipment.


A detection and indication system for use in a railway switch machine which utilizes one or more roller members which physically interact with a point detector bar coupled to one or more switch points to provide an indication of a point failure upon movement of the point detector bar a predetermined distance from an initial position. The system includes a mounting structure structured to be coupled to a housing of the switch machine and a first sensing device coupled to the mounting structure. The first sensing device is positioned and structured to detect movement of the point detector bar a second predetermined distance from the initial position, wherein the second predetermined distance is less than the first predetermined distance.


A railroad monitoring apparatus includes first and second diverse vital processing units, first and second current sensors configured to measure the current being provided to one or more signaling elements of an item of wayside signaling equipment, and means for measuring voltage levels being supplied to each of the signaling elements. The first processing unit receives a first current measurement from the first current sensor and the measured voltage levels, and the second vital processing unit receives a second current measurement from the second current sensor and the measured voltage levels. The vital processing units are each programmed to determine based on one or more of the first current measurement, the second current measurement and the measured voltage levels: (i) the state of the item of railroad wayside signaling equipment, (ii) failures within the item of railroad wayside signaling equipment, and (iii) failures within the monitoring apparatus itself.


Patent
STS Inc | Date: 2012-05-24

An electronic amplifier includes a configurable integrated circuit device structured to synthesize at least a first signal and a second signal, scale the first signal to create a scaled first signal and scale the second signal to create a scaled second signal, create a discrete time composite signal which comprises a summation of at least the scaled first signal and the scaled second signal, create a discrete time pulse width modulated signal based on the discrete time composite signal, and generate a number of control signals based on the discrete time pulse width modulated signal. The electronic amplifier also includes a power switching stage receiving the number of control signals from the configurable integrated circuit device, wherein the number of control signals are configured to control the power switching stage, and a low pass filter coupled to an output of the power switching stage.


A sequential monitoring system is for an interlocking logic system and a track circuit system including a plurality of track circuits. The sequential monitoring system includes an interface between the interlocking logic system and the track circuit system; and a processor structured to monitor a state of each of the track circuits, validate a sequence of state changes of the track circuits, and interrupt and correct invalid track circuit state indications between the track circuit system and the interlocking logic system. The interface normally passes inputs from the track circuit system to outputs to the interlocking logic system. When an out of sequence event occurs, the processor applies a quarantine to a minimum of three of the track circuits in a quarantined area, thereby inhibiting use of an unoccupied track circuit in the quarantined area.


Patent
STS Inc | Date: 2014-02-11

A method of controlling braking of a train that includes obtaining in an on-board computer of the train a brake propagation delay time (T_(d)), a brake build-up time (T) and a maximum brake rate (_(max)) for the train, and controlling braking of the train in the on-board computer by generating one or more braking signals for the train using T_(d), T and _(max). Also, a methods of determining for a train a profile velocity to a target position of a selected target, selecting a most restrictive target from among a plurality of targets for a train, and determining a plurality of braking parameters for a train having a train consist, wherein the parameters include a brake propagation delay time (T_(d)), a brake build-up time (T) and a maximum brake rate (_(max)).

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