FENC Fennec Pharmaceuticals Inc.

6.56
+0.4  (+6%)
Previous Close 6.16
Open 6.24
52 Week Low 4.2
52 Week High 10.67
Market Cap $166,335,583
Shares 25,809,684
Float 12,598,082
Enterprise Value $133,790,814
Volume 359,408
Av. Daily Volume 472,859
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Drug Pipeline

Drug Stage Notes
Pedmark (sodium thiosulfate)
Cisplatin-Induced Hearing Loss
CRL
CRL
CRL announced August 10, 2020.

Latest News

  1. The law firm of Kirby McInerney LLP is investigating potential claims against Fennec Pharmaceuticals Inc. ("Fennec" or the "Company") (NASDAQ:FENC). The investigation concerns whether Fennec and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.

    On August 11, 2020, Fennec issued a press release announcing receipt of a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") regarding the Company's New Drug Application ("NDA") for the Company's PEDMARK product, a formulation of sodium thiosulfate for intravenous administration for the ototoxicity associated with cisplatin chemotherapy. The press release advised investors that "[a]ccording to the CRL, after…

    The law firm of Kirby McInerney LLP is investigating potential claims against Fennec Pharmaceuticals Inc. ("Fennec" or the "Company") (NASDAQ:FENC). The investigation concerns whether Fennec and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.

    On August 11, 2020, Fennec issued a press release announcing receipt of a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") regarding the Company's New Drug Application ("NDA") for the Company's PEDMARK product, a formulation of sodium thiosulfate for intravenous administration for the ototoxicity associated with cisplatin chemotherapy. The press release advised investors that "[a]ccording to the CRL, after recent completion of a pre-approval inspection of the manufacturing facility of our drug product manufacturer, the FDA identified deficiencies resulting in a Form 483, which is a list of conditions or practices that are required to be resolved prior to the approval of PEDMARK. The Company plans to request a Type A meeting to discuss the issues and other matters that were described in the CRL pertaining to the steps required for the resubmission of the NDA for PEDMARK."

    On this news, Fennec's stock price fell $3.51 per share, or 34.51%, to close at $6.66 per share on August 11, 2020.

    If you purchased or otherwise acquired Fennec securities, have information, or would like to learn more about these claims, please contact Thomas W. Elrod of Kirby McInerney LLP at 212-371-6600, by email at , or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.

    Kirby McInerney LLP is a New York-based plaintiffs' law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm's efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP's website: http://www.kmllp.com.

    This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

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  2. RESEARCH TRIANGLE PARK, N.C., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that Rosty Raykov, Chief Executive Officer of Fennec will present at the following upcoming investor conferences. The following presentations will be webcast live and can be accessed by visiting the investors relations section of the Company's website at http://investors.fennecpharma.com/events-and-presentations/presentations.  A replay of each presentation will also be available and archived on the site for 90 days.

    • 2020 Wedbush PacGrow Healthcare Conference – Presentation being held on Wednesday, August 12, at 2:55 p.m. ET. 

    • H.C. Wainwright Global Investment Conference – Presentation being held…

    RESEARCH TRIANGLE PARK, N.C., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that Rosty Raykov, Chief Executive Officer of Fennec will present at the following upcoming investor conferences. The following presentations will be webcast live and can be accessed by visiting the investors relations section of the Company's website at http://investors.fennecpharma.com/events-and-presentations/presentations.  A replay of each presentation will also be available and archived on the site for 90 days.

    • 2020 Wedbush PacGrow Healthcare Conference – Presentation being held on Wednesday, August 12, at 2:55 p.m. ET. 



    • H.C. Wainwright Global Investment Conference – Presentation being held on September 14-16.



    • Cantor Fitzgerald Virtual Global Healthcare Conference – Presentation being held on September 15th, at 12:20 pm ET.

    About PEDMARK™ (A unique formulation of sodium thiosulfate (STS))

    Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies.  Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and is particularly harmful to the survivors of pediatric cancer.

    In the U.S. and Europe, it is estimated annually that over 10,000 children may receive platinum-based chemotherapy.  The incidence of ototoxicity 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 type of 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 that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

    PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Children Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. 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.

    The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA).  PEDMARK has received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018.

    About Fennec Pharmaceuticals

    Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARK for the prevention of platinum-induced ototoxicity in pediatric patients.  Further, PEDMARK has received Orphan Drug Designation in the U.S. for this setting.  Fennec has a license agreement with Oregon Health and Science University (OHSU) for exclusive worldwide license rights to intellectual property directed to STS and its use for chemoprotection, including the prevention of ototoxicity induced by platinum chemotherapy, in humans.  For more information, please visit www.fennecpharma.com

    Forward-Looking Statements 

    Except for historical information described in this press release, all other statements are forward-looking. These forward-looking statements include the Company's expectations regarding its interactions and communications with the FDA, including its expectation to discuss with the FDA the issues raised in the CRL and the Company's plans to address them.  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 and uncertainties that regulatory and guideline developments may change, scientific data and/or manufacturing capabilities 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, Fennec's reliance on third party manufacturing, unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, 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, 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, 2019 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. Fennec 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.

    For further information, please contact:

    Investors:

    Rosty Raykov

    Chief Executive Officer

    Fennec Pharmaceuticals Inc.

    +1 919-636-5144

    Primary Logo

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  3. ~ No Clinical Safety or Efficacy Issues Identified, and No Requirement for Further Clinical Data ~

    ~ FDA Pre-Approval Inspection has Identified Deficiencies with the Facility of the Drug Product Manufacturer, which Require Resolution Prior to PEDMARK Approval ~

    ~ Company to Host Conference Call and Webcast Today, Tuesday, August 11, 2020, at 8:30 a.m. ET ~

    RESEARCH TRIANGLE PARK, N.C., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) on August 10, 2020 from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for PEDMARK™ (a unique formulation of sodium thiosulfate), for intravenous administration…

    ~ No Clinical Safety or Efficacy Issues Identified, and No Requirement for Further Clinical Data ~

    ~ FDA Pre-Approval Inspection has Identified Deficiencies with the Facility of the Drug Product Manufacturer, which Require Resolution Prior to PEDMARK Approval ~

    ~ Company to Host Conference Call and Webcast Today, Tuesday, August 11, 2020, at 8:30 a.m. ET ~

    RESEARCH TRIANGLE PARK, N.C., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) on August 10, 2020 from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for PEDMARK™ (a unique formulation of sodium thiosulfate), for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients ≥1 month to 18 years of age with localized, non-metastatic, solid tumors.

    According to the CRL, after recent completion of a pre-approval inspection of the manufacturing facility of our drug product manufacturer, the FDA identified deficiencies resulting in a Form 483, which is a list of conditions or practices that are required to be resolved prior to the approval of PEDMARK™.  The Company plans to request a Type A meeting to discuss the issues and other matters that were described in the CRL pertaining to the steps required for the resubmission of the NDA for PEDMARK™.  Importantly, no clinical safety or efficacy issues were identified during the review and there is no requirement for further clinical data.

    "We are steadfast in our commitment to reducing the risk of life-long hearing loss for children receiving cisplatin chemotherapy who currently have no approved therapies for this devastating condition," said Rosty Raykov, chief executive officer of Fennec. "We will work closely with our manufacturer and the FDA to fully address the issues raised in the letter as expeditiously as possible."

    The Company has existing cash, which totaled approximately $38.7 million as of June 30, 2020.

    Conference Call and Webcast

    Fennec will host a conference call and webcast on Tuesday, August 11, 2020, at 8:30 a.m. ET. The conference call can be accessed by dialing (833) 614-1446 for domestic callers or (918) 922-6512 for international callers. Please provide the operator with the conference ID 7791698 to join the conference call.

    About PEDMARK™ (A unique formulation of sodium thiosulfate (STS))

    Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies.  Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and is particularly harmful to the survivors of pediatric cancer.



    In the U.S. and Europe, it is estimated annually that over 10,000 children may receive platinum-based chemotherapy.  The incidence of ototoxicity 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 type of 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 that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.



    PEDMARK 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 have been completed. 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.



    The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA).  PEDMARK has received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018. 



    About Fennec Pharmaceuticals

    Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARK for the prevention of platinum-induced ototoxicity in pediatric patients.  Further, PEDMARK has received Orphan Drug Designation in the U.S. for this setting.  Fennec has a license agreement with Oregon Health and Science University (OHSU) for exclusive worldwide license rights to intellectual property directed to STS and its use for chemoprotection, including the prevention of ototoxicity induced by platinum chemotherapy, in humans.  For more information, please visit www.fennecpharma.com.



    Forward-Looking Statements 

    Except for historical information described in this press release, all other statements are forward-looking. These forward-looking statements include the Company's expectations regarding its interactions and communications with the FDA, including its expectation to discuss with the FDA the issues raised in the CRL and the Company's plans to address them.  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 and uncertainties that regulatory and guideline developments may change, scientific data and/or manufacturing capabilities 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, Fennec's reliance on third party manufacturing, unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, 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, 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, 2019 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. Fennec 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.



    For further information, please contact:

    Investors:

    Rosty Raykov

    Chief Executive Officer

    Fennec Pharmaceuticals Inc.

    +1 919-636-5144

    Corporate and Media:

    Elixir Health Public Relations

    Lindsay Rocco

    +1 862-596-1304

    Primary Logo

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  4. ~ FDA Set a PDUFA Target Action Date for PEDMARKTM of August 10, 2020 ~
    ~ Strong Financial Position with $38.7 million in cash and no debt ~

    RESEARCH TRIANGLE PARK, N.C., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC, TSX:FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients, today reported its financial results for the second quarter ended June 30, 2020 and provided a business update.

    "We continue to work with the FDA as a part of their review process in advance of the pending PEDMARKTM PDUFA date of August 10," said Rosty Raykov, chief executive officer of Fennec…

    ~ FDA Set a PDUFA Target Action Date for PEDMARKTM of August 10, 2020 ~

    ~ Strong Financial Position with $38.7 million in cash and no debt ~

    RESEARCH TRIANGLE PARK, N.C., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC, TSX:FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients, today reported its financial results for the second quarter ended June 30, 2020 and provided a business update.

    "We continue to work with the FDA as a part of their review process in advance of the pending PEDMARKTM PDUFA date of August 10," said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. "Our organization and commercial team have been actively preparing for launch readiness, and, as we await the FDA's decision, we believe that we are well positioned to commercialize PEDMARK, if approved, during the third quarter of 2020."

    Financial Results for the First Quarter 2020

    • Cash Position – Cash and cash equivalents were $38.7 million as of June 30, 2020. The increase in cash balance is the result of the Company raising approximately $32 million in net proceeds through a public offering in May 2020. This increase in cash balance was offset by cash used for operating activities including regulatory submissions of PEDMARKTM and expenses associated with commercial and operational launch preparation. As of June 30, 2020, the Company has no funded debt.
    • Research and Development (R&D) Expenses – R&D expenses were $1.1 million for the second quarter ended June 30, 2020, compared to $2.0 million for the same period in 2019. The Company has completed most of the activities needed for regulatory approval of PEDMARKTM and a significant amount of its activities are now focused on commercialization readiness in preparation for the potential launch of PEDMARKTM.
    • General and Administrative (G&A) Expenses – G&A expenses for the second quarter ended June 30, 2020, increased by $0.9 million over the same period in 2019, reflecting the Company's focus on commercializing PEDMARKTM. The increase in G&A during the quarter was primarily due to commercialization readiness activities and increased headcount which was partially offset by reduced non-cash equity compensation.
    • Net Loss – Net loss for the quarter ended June 30, 2020 was $4.8 million ($0.21 per share), compared to $4.7 million ($0.24 per share) for the same period in 2019.

    Financial Update

    The selected financial data presented below are derived from our unaudited condensed consolidated financial statements, which were prepared in accordance with U.S. generally accepted accounting principles. The complete unaudited condensed consolidated financial statements for the period ended June 30, 2020 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.

    Unaudited Condensed Consolidated

    Statements of Operations:

    (U.S. Dollars in thousands except per share amounts)

     Three Months Ended 
     June 30,  June 30, 
     2020  2019 
          
    Revenue$-  $- 
            
    Operating expenses:       
    Research and development 1,121   1,969 
    General and administrative 3,724   2,844 
            
    Loss from operations (4,845)  (4,813)
            
    Other (expense)/income       
    Amortization expense (30)  (17)
    Other loss 13   (10)
    Net interest income 17   110 
    Total other income, net -   83 
            
    Net (loss)$(4,845) $(4,730)
            
    Basic net (loss) per common share$(0.21) $(0.24)
            
    Diluted net (loss) per common share$(0.21) $(0.24)



    Fennec Pharmaceuticals Inc.
    Balance Sheets
    (U.S. Dollars in thousands)
     
     Unaudited

    June 30,

    2020
     Audited

    December 31,

    2019
     
    Assets      
    Cash and cash equivalents$38,729 $13,650 
    Other current assets 170  234 
    Non-current assets, net 417  262 
    Total Assets$39,316 $14,146 
           
    Liabilities and stockholders' equity      
    Current liabilities$3,190  $2,271 
    Total stockholders' equity 36,126  11,875 
    Total liabilities and stockholders' equity $39,316  $14,146 

      

     

      

    Working Capital Fiscal Year Ended 
    Selected Asset and Liability Data: June 30,

    2020
      December 31,

    2019
     
    (U.S. Dollars in thousands)      
    Cash and cash equivalents $38,729  $13,650 
    Other current assets  170   234 
    Current liabilities  (3,190)  (2,271)
    Working capital $35,709  $11,613 
             
    Selected Equity:        
    Common stock & APIC $187,585  $154,663 
    Accumulated deficit  (152,702)  (144,031)
    Stockholders' equity  36,126   11,875 

    About PEDMARK™ 

    Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies.  Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and particularly harmful to the survivors of pediatric cancer.

    In the U.S. and Europe, it is estimated that, annually, over 10,000 children may receive platinum-based chemotherapy.  The incidence of ototoxicity 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 that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

    PEDMARK 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 have been completed. 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.

    The FDA has accepted for filing the Company's New Drug Application (NDA) for PEDMARK™ and has granted Priority Review. The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename to be determined) is currently under evaluation by the European Medicines Agency (EMA).  PEDMARK has received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018, and a Prescription Drug User Fee Act (PDUFA) Target Action Date of August 10, 2020

    About Fennec Pharmaceuticals

    Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARK for the prevention of platinum-induced ototoxicity in pediatric patients.   Further, PEDMARK has received Orphan Drug Designation in the U.S. for this potential use.  Fennec has a license agreement with Oregon Health and Science University (OHSU) for exclusive worldwide license rights to intellectual property directed to sodium thiosulfate and its use for chemoprotection, including the prevention of ototoxicity induced by platinum chemotherapy, in humans.  For more information, please visit www.fennecpharma.com

    Forward Looking Statements

    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 as unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, 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 product will not be as large as expected, the Company's product  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, 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, 2019. 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.

    For further information, please contact:

    Investors:

    Rosty Raykov

    Chief Executive Officer

    Fennec Pharmaceuticals Inc.

    (919) 636-5144

    Media:

    Elixir Health Public Relations

    Lindsay Rocco

    (862) 596-1304



    Primary Logo

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  5. RESEARCH TRIANGLE PARK, N.C., June 26, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC, TSX:FRX), a specialty pharmaceutical company focused on the development of PEDMARK™ (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients, today announced an amendment to its existing senior debt facility with the Life Sciences Group at Bridge Bank increasing the size of the facility from $12.5 million to $18 million.

    The U.S. operating subsidiary of Fennec Pharmaceuticals Inc., entered into a First Amendment to the 2019 Loan and Security Agreement with Bridge Bank. This amendment provides Fennec with an $18 million debt facility comprised of two term loans.  Term Loan A…

    RESEARCH TRIANGLE PARK, N.C., June 26, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC, TSX:FRX), a specialty pharmaceutical company focused on the development of PEDMARK™ (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients, today announced an amendment to its existing senior debt facility with the Life Sciences Group at Bridge Bank increasing the size of the facility from $12.5 million to $18 million.

    The U.S. operating subsidiary of Fennec Pharmaceuticals Inc., entered into a First Amendment to the 2019 Loan and Security Agreement with Bridge Bank. This amendment provides Fennec with an $18 million debt facility comprised of two term loans.  Term Loan A consists of $12.5 million to be funded upon New Drug Application (NDA) approval of PEDMARK™ in the U.S. Term Loan B consists of $5.5 million to be funded upon the occurrence of a revenue event in 2021.  The interest-only period for the facility has the ability to be extended from 18 months to 24 months from the funding of Term Loan A, provided that Term Loan B is funded and certain conditions are met.  The Company intends to use the proceeds from the loans to provide working capital for commercialization activities for PEDMARK™ upon NDA approval.

    "This loan amendment further strengthens our balance sheet and provides us with additional operating capital and flexibility as we prepare for the launch of PEDMARK™, if approved, in the second half of 2020," said Robert Andrade, chief financial officer of Fennec Pharmaceuticals.  "We are pleased to expand our relationship with Bridge Bank, a premier lending institution with a broad scope of services."

    "We have been working with Fennec for the past two years and are excited to continue working with the company as they transition to becoming a commercial-stage organization," said Ms. Lindsay Fouty, vice president in Bridge Bank's Life Sciences Group. "We are pleased to provide flexible debt capital to support the launch of PEDMARK™, which addresses an important unmet medical need for the prevention of ototoxicity in children receiving cisplatin chemotherapy."

    About Fennec Pharmaceuticals

    Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARK for the prevention of platinum-induced ototoxicity in pediatric patients.   Further, PEDMARK has received Orphan Drug Designation in the U.S. for this potential use.  Fennec has a license agreement with Oregon Health and Science University (OHSU) for exclusive worldwide license rights to intellectual property directed to sodium thiosulfate and its use for chemoprotection, including the prevention of ototoxicity induced by platinum chemotherapy, in humans.  For more information, please visit www.fennecpharma.com.

    About PEDMARK™ 

    Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies.  Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and particularly harmful to the survivors of pediatric cancer.

    In the U.S. and Europe, it is estimated that, annually, over 10,000 children may receive platinum-based chemotherapy.  The incidence of ototoxicity 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 that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

    PEDMARK 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 have been completed. 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.

    The FDA has accepted for filing the Company's New Drug Application (NDA) for PEDMARK™ and has granted Priority Review. The Marketing Authorization Application (MAA) for Pedmarqsi (EU tradename) is currently under evaluation by the European Medicines Agency (EMA).  PEDMARK has received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018, and a Prescription Drug User Fee Act (PDUFA) Target Action Date of August 10, 2020.

    About Bridge Bank

    Bridge Bank, a division of Western Alliance Bank, Member FDIC, helps business clients realize their ambitions. Founded in 2001 in Silicon Valley, Bridge Bank offers a better way to bank for small-market and middle-market businesses across many industries, as well as emerging technology companies and the private equity community. Geared to serving both venture-backed and non-venture-backed companies, Bridge Bank delivers a broad scope of financial solutions including capital, equipment and working capital credit facilities, venture debt, treasury management, asset-based lending, SBA and commercial real estate loans, ESOP finance and a full line of international products and services. Based in San Jose, Bridge Bank has 16 offices in major markets across the country along with Western Alliance Bank's powerful array of specialized financial services. Western Alliance Bank is the primary subsidiary of Phoenix-based Western Alliance Bancorporation. One of the country's top-performing banking companies, Western Alliance has ranked in the top 10 on the Forbes "Best Banks in America" list for five consecutive years, 2016-2020, and was named #1 best-performing of the 50 largest public U.S. banks for 2019 by S&P Global Market Intelligence. For more information, visit bridgebank.com.

    Forward Looking Statements

    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 as unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, 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 product will not be as large as expected, the Company's product  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, 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, 2019. 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.

    For further information, please contact:

    Investors:

    Rosty Raykov

    Chief Executive Officer

    Fennec Pharmaceuticals Inc.

    (919) 636-5144

    Media:

    Elixir Health Public Relations

    Lindsay Rocco

    (862) 596-1304

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