GlobeNewswire Inc | Nov 10, 2021 06:00AM EST

November 10, 2021

~ FDA Prescription Drug User Fee Act (PDUFA) Target Action Date Set for November 27, 2021 ~~W0:

~ If Approved by the FDA, PEDMARKStands to Be the First Therapy for the Prevention of Cisplatin-Induced Hearing Loss in Children ~~W0:

~ Company Has Approximately $24 Million in Cash and Cash Equivalents ~~W0:

RESEARCH TRIANGLE PARK, N.C., Nov. 10, 2021 (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, 2021 and provided a business update.

We continue to work with the FDA on their review of our NDA application, in advance of the pending PEDMARKPDUFA target action date of November 27th. We are focused on essential activities in preparation to bring this important treatment to children receiving cisplatin chemotherapy, said Rosty Raykov, chief executive officer ofFennec Pharmaceuticals, Inc.

Financial Results for the Third Quarter 2021

-- Cash Position Cash and cash equivalents were $24.3 million as of September 30, 2021. The decrease in cash and cash equivalents between September 30, 2021, and June 30, 2020 is the result of expenses related to the development and preparation of the NDA resubmission of PEDMARKand general and administrative expenses. As of September 30, 2021, the Company had $5.0 million in funded debt. -- Research and Development (R&D) ExpensesR&D expenses were $1.2 million for the third quarter ended September 30, 2021 compared to $1.4 million for the same period in 2020. R&D expenses decreased by $0.2 million for the three months ended September 30, 2021 over the same period in 2020 as the Companys development activities shifted back to essential activities in preparation for the launch of PEDMARK. -- General and Administrative (G&A) Expenses G&A expenses decreased by $1.6 million over same period in 2020 due to the timing to NDA approval of the comparative periods. The three months ended September 30, 2020 was the same quarter as the initial NDA approval and the three months ended September 30, 2021 is one quarter prior to our current potential NDA approval. The reduction in general and administrative expenses was slightly offset by higher expenses associated with additional employees and the increase in non-cash equity remuneration expense for employees and board members related to the vesting of new and existing grants. -- Net Loss Net loss for the quarter ended September 30, 2021 was $4.2 million ($0.16 per share), compared to $6.2 million ($0.24 per share) for the same period in 2020.

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, 2021 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) ThreeMonthsEnded September 30, September 30, 2021 2020 Revenue $ ? $ ? Operating expenses: Research and development 1,242 1,368 General and administrative 2,931 4,491 Loss from operations (4,173 ) (5,859 ) Other (expense)/income Unrealized gain on securities 39 ? Amortization expense (8 ) (355 )Other loss (56 ) (8 )Interest income 13 22 Total other income, net (12 ) (341 ) Net (loss) $ (4,185 ) $ (6,200 ) Basic net (loss) per common share $ (0.16 ) $ (0.24 ) Diluted net (loss) per common share $ (0.16 ) $ (0.24 )

Fennec Pharmaceuticals Inc.Balance Sheets(U.S. Dollars in thousands) September30,2021 December31, (Unaudited) 2020 Assets Current assets Cash and cash equivalents $ 24,335 $ 30,344 Prepaid expenses 1,232 797 Other current assets 412 276 Total current assets 25,979 31,417 Non-Current assets Deferred issuance cost 508 466 Deferred issuance cost (amortization) (473 ) (466 )Total non-current assets 35 ? Total assets $ 26,014 $ 31,417 Liabilities and Shareholders? Equity Current liabilities: Accounts payable $ 1,154 $ 1,571 Accrued liabilities 860 776 Total current liabilities 2,014 2,347 Long term liabilities Term loan 5,000 ? Debt discount (13 ) ? Total long term liabilities 4,987 ? Total liabilities 7,001 2,347 Shareholders? equity: Common stock, no par value; unlimitedshares authorized; 26,010 shares issued 140,780 140,733 and outstanding (2020 -26,003)Additional paid-in capital 52,049 49,234 Accumulated deficit (175,059 ) (162,140 )Accumulated other comprehensive income 1,243 1,243 Total shareholders? equity 19,013 29,070 Total liabilities and shareholders? equity $ 26,014 $ 31,417

Working Capital FiscalYearEndedSelected Asset and Liability Data: September 30, December31, 2021 2020(U.S. Dollars in thousands) Cash and cash equivalents $ 24,335 $ 30,344 Other current assets 1,644 1,073 Current liabilities (2,014 ) (2,347 )Working capital $ 23,965 $ 29,070 Selected Equity: Common stock & APIC $ 192,829 $ 189,967 Accumulated deficit (175,059 ) (162,140 )Stockholders? equity 19,013 29,070

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 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 Companys New Drug Application (NDA) for PEDMARK and has granted Priority Review. PEDMARK has received Breakthrough Therapy and Fast Track Designation by the FDA inMarch 2018, and a Prescription Drug User Fee Act (PDUFA) Target Action Date ofNovember 27, 2021. The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by theEuropean Medicines Agency(EMA).

About Fennec Pharmaceuticals

Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARKfor 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 visitwww.fennecpharma.com

Forward Looking Statements

Except for historical information described in this press release, all other statements are forward-looking. Words such as believe, anticipate, plan, expect, estimate, intend, may, will, or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include the Companys expectations regarding its interactions and communications with the FDA, including the Companys expectations and goals respecting the NDA resubmission for PEDMARK. Obtaining Fast Track Designation and Breakthrough Therapy Designation by the FDA is no guarantee that the FDA will approve the NDA resubmission of PEDMARK. Forward-looking statements are subject to certain risks and uncertainties inherent in the Companys business that could cause actual results to vary, including the risk that unforeseen factors may result in delays in or failure to obtain FDA approval of PEDMARK, the risks and uncertainties relating to the Companys reliance on third party manufacturing, the risks that the Companys NDA resubmission does not adequately address the concerns identified in the CRL previously provided by the FDA, the risk that the NDA resubmission to the FDA will not be satisfactory, 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, 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 the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 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:Robert AndradeChief Financial OfficerFennec Pharmaceuticals Inc.(919) 246-5299

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