Fennec Pharmaceuticals Announces First Quarter 2022

~FDA’s Prescription Drug User Fee Act (PDUFA) target action date is September 23, 2022~

~ If FDA approved, PEDMARKMT Claims to be the first therapy for the prevention of cisplatin-induced hearing loss in children~

~The company has approximately $18.3 million in cash and $5 million in funded debt~

RESEARCH TRIANGLE PARK, NC, May 12, 2022 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company focused on developing PEDMARKMT (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients, today announced its financial results for the fiscal quarter ended March 31, 2022 and provided an update on its activities.

“We are delighted that the FDA has accepted our new NDA submission for PEDMARK™, said Rosty Raykov, Chief Executive Officer of Fennec Pharmaceuticals. “As we work closely with the FDA to facilitate their review of our NDA, we continued to execute key initiatives across our commercial, clinical and manufacturing operations. Our commercial team is actively preparing for launch preparation as we expect a decision from the FDA by the PDUFA target action date of September 23, 2022.”

Upcoming Investor Event

  • Annual Meeting of Shareholders – Fennec would like to invite shareholders to attend its Annual General Meeting on Tuesday, June 14, 2022 at 11:00 a.m. ET, which will be held in person at The Fifty Sonesta Select Hotel, The Den Room, 155 East 50and Street at Third Avenue, New York, NY 10022, USA, or online by visiting www.virtualshareholdermeeting.com/FENC2022.

First quarter 2022 financial results

  • Treasury – Cash and cash equivalents were $18.3 million as of March 31, 2022. The decrease in cash and cash equivalents between March 31, 2022 and December 31, 2021 is the result of development related expenses and the preparation of our new drug application (NDA) resubmission of PEDMARK™ and general and administrative expenses.
  • Research and development (R&D) expenditure – R&D expenses were $1.4 million for the first quarter ended March 31, 2022, compared to $2.4 million for the same period in 2021. R&D expenses decreased by 1.0 million for the quarter ended March 31, 2022 compared to the same period in 2021 as the Company’s expenses. development activities diminished those of the company as year-over-year efforts were less focused on development and shifted to pre-commercialization activities.
  • General and administrative expenses (G&A) – General and administrative expenses were $2.1 million for the first quarter ended March 31, 2022, compared to $2.5 million for the same period in 2021. The decrease in general and administrative expenses compared to the same period in 2021 reflects certain expenses associated with pre-marketing that need not be repeated as they were completed in 2021.
  • Net loss – Net loss for the three months ended March 31, 2022 was $3.7 million ($0.14 per share), compared to $4.7 million ($0.18 per share) for the same period in 2021.

Financial update

Selected financial information presented below is derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles. The complete unaudited condensed consolidated financial statements for the period ended March 31, 2022 along with the MD&A and discussion of financial condition and results of operations will be available at www.sec.gov and www.sedar.com . All values ​​are presented in thousands, unless otherwise indicated.

Unaudited Condensed Consolidated
Transaction states:
(in thousands of US dollars, except per share amounts)

Three months completed
March, 31st, March, 31st,
2022 2021
Revenue $ $
Operating costs :
Research and development 1,437 2,416
general and administrative 2,109 2,507
Operating loss (3,546 ) (4,923 )
Other (expenses)/income
Unrealized (Loss)/Gain on Securities (91 ) 182
Depreciation expense (7 )
Interest and other charges (61 ) (8 )
Net interest income 9 16
Total other (expenses)/income, net (150 ) 190
Net loss) $ (3,696 ) $ (4,733 )
Basic (net loss) per common share $ (0.14 ) $ (0.18 )
Diluted net (loss) per common share $ (0.14 ) $ (0.18 )
Fennec Pharmaceuticals Inc.
Balance sheets
(US dollars in thousands)
Unaudited
March, 31st,
2022
Checked
The 31st of December,
2021
Assets
Current assets
Cash and cash equivalents $ 18,259 $ 21,100
Other current assets 869 1,287
Non-current assets, net 21 27
Total assets $ 19,149 $ 22,414
Liabilities and equity
Current liabilities $ 2,136 $ 1,654
Non-current liabilities, net 4,489 4,988
Full shareholder equity 12,524 15,772
Total Liabilities and Equity $ 19,149 $ 22,414

Working capital Year closed
Selected asset and liability data: March, 31st,
2022
The 31st of December,
2021
(US dollars in thousands)
Cash and cash equivalents $ 18,259 $ 21,100
Other current assets 869 1,287
Current liabilities (2,136 ) (1,654 )
Working capital $ 16,992 $ 20,733
Selected actions:
Common Stock and APIC $ 194,463 $ 194,015
Accumulated deficit (183 182 ) (179,486 )
Equity 12,524 15,772

About PEDMARK™

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

In the United States and Europe, it is estimated that more than 10,000 children each year may receive platinum-based chemotherapy. The incidence of ototoxicity depends on the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There are currently no established preventive agents for this hearing loss and only expensive, technically difficult and suboptimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children who experience ototoxicity at critical developmental stages lack speech language development and literacy, and older children and adolescents lack social-emotional development and academic achievement.

PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies for survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. COG protocol ACCL0431 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 only enrolled patients with hepatoblastoma with localized tumours.

The Marketing Authorization Application (MA) for sodium thiosulfate (trade name PEDMARQSI) is currently being assessed by the European Medicines Agency (EMA). PEDMARK received Breakthrough Therapy and Fast Track designation from 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. Additionally, PEDMARK has received Orphan Drug Designation in the United States for this potential use. Fennec has a licensing agreement with Oregon Health and Science University (OHSU) for exclusive worldwide licensing rights to intellectual property relating to sodium thiosulfate and its use for chemoprotection, including the prevention of induced ototoxicity 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. Words such as “believe”, “anticipate”, “plan”, “expect”, “estimate”, “intend”, “may”, “will”, or the negative of these terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include the Company’s expectations regarding its interactions and communications with the FDA, including the Company’s expectations and goals regarding the new NDA submission for PEDMARK™. Obtaining Fast Track Designation and Breakthrough Therapy Designation by the FDA does not guarantee that the FDA will approve PEDMARK’s new NDA submission. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including the risk that unforeseen factors could cause delays or failure to obtain the FDA for PEDMARK, the risks and uncertainties associated with the Company’s reliance on third-party manufacturing, the risks that the Company’s new NDA submission will not adequately address the concerns identified in CRL previously provided by FDA, risk that resubmission of NDA to FDA may not be satisfactory, regulatory developments and guidelines may change, scientific data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or obtain required regulatory clearances or approvals, clinical results may not wind not be replicated in actual patient environments, unforeseen global instability, including political instability, or instability of a pandemic or contagious disease outbreak, such as the novel coronavirus (COVID-19), or surrounding duration and the severity of an epidemic, the protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the market available for the Company’s products will not be as large as expected, the the Company’s products will not be able to penetrate one or more targeted markets, the revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital needs in different countries and municipalities , and other risks detailed from time to time in documents filed by the Company with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021. 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 see our public documents available at www.sec.gov and www.sedar.com.

For more information, please contact:
Investors:
Robert Andrade
Financial director
Fennec Pharmaceuticals Inc.
(919) 246-5299

Media:
Health Elixir Public Relations
Lindsay Rocco
(862) 596-1304
[email protected]

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