GlobeNewswire Inc | Nov 16, 2020 07:02AM EST

November 16, 2020

~ The Company Continues to Work with the FDA and Its Third-Party Drug Product Manufacturer to Fully Address CRL and Prepare NDA Resubmission for PEDMARK~~W0:

~ No Clinical Safety or Efficacy Issues Identified; No Additional Studies Requiredfor PEDMARK~~W0:

~~W0:The Company Has Approximately $33 Million in Cash and No Outstanding Debt ~~W0:

RESEARCH TRIANGLE PARK, N.C., Nov. 16, 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 reported its financial results for the third quarter ended September 30, 2020 and provided a business update.

We are pleased with the recent constructive and collaborative Type A meeting with the FDA to discuss the path forward for resubmission of the New Drug Application (NDA) for PEDMARKfor the prevention of life-long hearing loss for children receiving cisplatin chemotherapy, said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. Importantly, there were no clinical or safety issues identified in the complete response letter (CRL) and there are no requirements for additional clinical data within the CRL. We are working closely with the FDA and our third-party drug product manufacturer to fully address the CRL and plan to resubmit the NDA for PEDMARKwith the goal of achieving regulatory approval and making PEDMARKcommercially available to patients in need as quickly as possible.

Financial Results for the ThirdQuarter2020

-- Cash Position Cash and cash equivalents were $33.2 million as of September 30, 2020. The reduction in cash balance is the result of cash used for operating activities including regulatory activities of PEDMARKand expenses associated with commercial and operational launch preparation during the quarter. As of September 30, 2020, the Company has no funded debt. -- Research and Development (R&D) Expenses R&D expenses were $1.4 million for the third quarter ended September 30, 2020, compared to $0.8 million for the same period in 2019. The increase in R&D in the quarter was due to an increase in R&D expenses after the Complete Response Letter (CRL). -- General and Administrative (G&A) Expenses G&A expenses for the third quarter ended September 30, 2020, increased by $3.4 million over the same period in 2019, reflecting the Companys focus on commercialization readiness of PEDMARK. The increase in G&A during the quarter was primarily due to commercialization readiness activities during the quarter leading up to the PDUFA date of PEDMARK in August 2020. -- Net Loss Net loss for the quarter ended September 30, 2020 was $6.2 million ($0.24 per share), compared to $1.8 million ($0.09 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 September 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 ConsolidatedStatements of Operations:(U.S. Dollars in thousands except per share amounts)

Three Months Ended September 30, September 30, 2020 2019 Revenue $ - $ - Operating expenses: Research and development 1,368 795 General and administrative 4,491 1,068 Loss from operations (5,859 ) (1,863 ) Other (expense)/income Amortization expense (355 ) (17 )Other loss (8 ) 1 Net interest income 22 70 Total other income, net (341 ) 54 Net (loss) $ (6,200 ) $ (1,809 ) Basic net (loss) per common share $ (0.24 ) $ (0.09 ) Diluted net (loss) per common share $ (0.24 ) $ (0.09 )

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

Unaudited Audited September 30, December 31, 2020 2019Assets Cash and cash equivalents $ 33,166 $ 13,650Other current assets 904 234Non-current assets, net - 262Total Assets $ 34,070 $ 14,146 Liabilities and stockholders? equity Current liabilities $ 2,885 $ 2,271Total stockholders? equity 31,185 11,875Total liabilities and stockholders? equity $ 34,070 $ 14,146

Working Capital Fiscal Year Ended Selected Asset and Liability Data: September 30, December 31, 2020 2019(U.S. Dollars in thousands) Cash and cash equivalents $ 33,166 $ 13,650 Other current assets 904 234 Current liabilities (2,885 ) (2,271 )Working capital $ 31,185 $ 11,613 Selected Equity: Common stock & APIC $ 188,844 $ 154,663 Accumulated deficit (158,902 ) (144,031 )Stockholders? equity 31,185 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. andEurope,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 Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by theEuropean Medicines Agency(EMA). PEDMARKhas received Breakthrough Therapy and Fast Track Designation by the FDA inMarch 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 potential use. Fennec has a license agreement withOregon 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. These forward-looking statements include the Companys 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 Companys plans to address them. Forward-looking statements are subject to certain risks and uncertainties inherent in the Companys 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, Fennecs 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 Companys patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Companys products will not be as large as expected, the Companys 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 Companys filings with theSecurities and Exchange Commissionincluding its Annual Report on Form 10-K for the year endedDecember 31, 2019and its Quarterly Report on Form 10-Q for the quarter endedSeptember 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 atwww.sec.govandwww.sedar.com.

For further information, please contact:

Investors:Rosty RaykovChief Executive OfficerFennec Pharmaceuticals Inc.(919) 636-5144

Media:Elixir Health Public RelationsLindsay Rocco(862) 596-1304lrocco@elixirhealthpr.com