Full Press Release Details
FENNEC PHARMACEUTICALS ANNOUNCES THIRD QUARTER
FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
~ PEDMARK Net Product Revenue of $6.5 Million, a 96% Increase Compared to Second Quarter ~
~ Strong Commercial Uptake Underscoring
Significant Unmet Medical Need ~
Received Approval in October 2023 by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. for PEDMARQSI
~ Management to Host Conference Call Today
Research Triangle Park, NC., Nov. 06, 2023
(GLOBE NEWSWIRE) - Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a commercial stage specialty pharmaceutical company,
today reported its financial results for the third quarter ended September 30, 2023 and provided a business update.
to see strong commercial performance with PEDMARK in the third quarter demonstrated by net product revenue of $6.5 million
representing 96% quarter over quarter growth. PEDMARK addresses a significant unmet medical need in the pediatric oncology
community, and we expect to continue building upon our commercial momentum through expanding the prescriber base and increasing the utilization
of the earlier endorsement from the NCCN for PEDMARK in the adolescent and young adult (AYA) population," said Rosty
Raykov, chief executive officer of Fennec Pharmaceuticals. "Further, we are pleased with the steady progress that we are making
preparing for the launch of PEDMARQSI in Europe, including the recent regulatory approval in the U.K. by the MHRA, as we continue to evaluate
the best commercial pathway for the Company in Europe."
Financial Results for the third Quarter
Q3 2023 CONFERENCE CALL
The Company will host a conference call today, November 6, at 8:30 a.m. ET, to discuss the Company's financial results from the
third quarter, ended September 30, 2023, and provide a business outlook for the remainder of 2023.
access the conference call, please register at: https://register.vevent.com/register/BId73242c7355a46d19e6aa1ff15435b87.
Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live
webcast link, log onto www.fennepharma.com and proceed to the News & Events / Event Calendar
page under the Investors & Media heading. Please connect to the company's website at least 15 minutes prior to the conference
call to ensure adequate time for any software download that may be required to listen to the webcast. A webcast replay of the conference
call will also be archived on www.fennecpharma.com for thirty days.
The selected financial data presented below is
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, 2023, 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 share and per
| Three Months Ended | ||||||||
| September 30, | September 30, | |||||||
| 2023 | 2022 | |||||||
| Revenue | ||||||||
| PEDMARK product sales, net | $ | 6,515 | $ | - | ||||
| Cost of products sold | (331 | ) | - | |||||
| Gross profit | 6,184 | - | ||||||
| Operating expenses: | ||||||||
| Research and development | 12 | 846 | ||||||
| Selling and marketing | 3,384 | - | ||||||
| General and administrative | 3,805 | 7,053 | ||||||
| Total operating expenses | 7,201 | 7,899 | ||||||
| Loss from operations | (1,017 | ) | (7,899 | ) | ||||
| Other (expense)/income | ||||||||
| Unrealized foreign exchange loss | (11 | ) | (4 | ) | ||||
| Amortization expense | (72 | ) | (64 | ) | ||||
| Unrealized loss on securities | (13 | ) | (27 | ) | ||||
| Interest income | 102 | 24 | ||||||
| Interest expense | (856 | ) | (119 | ) | ||||
| Total other (expense)/income | (850 | ) | (190 | ) | ||||
| Net loss | $ | (1,867 | ) | $ | (8,089 | ) | ||
| Basic net loss per common share | $ | (0.07 | ) | $ | (0.31 | ) | ||
| Diluted net loss per common share | $ | (0.07 | ) | $ | (0.31 | ) | ||
| Weighted-average number of common shares outstanding basic | 26,458 | 26,108 | ||||||
| Weighted-average number of common shares outstanding diluted | 26,458 | 26,108 |
Fennec Pharmaceuticals Inc.
(U.S. Dollars and shares in thousands)
| Unaudited | Audited | |||||||
| September 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 12,399 | $ | 23,774 | ||||
| Accounts receivable, net | 4,525 | 1,545 | ||||||
| Prepaid expenses | 247 | 770 | ||||||
| Inventory | 1,755 | 576 | ||||||
| Other current assets | 20 | 63 | ||||||
| Total current assets | 18,946 | 26,728 | ||||||
| Non-current assets | ||||||||
| Deferred issuance cost, net amortization | 82 | 211 | ||||||
| Total non-current assets | 82 | 211 | ||||||
| Total assets | $ | 19,028 | $ | 26,939 | ||||
| Liabilities and shareholders' (deficit) equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,941 | $ | 2,390 | ||||
| Accrued liabilities | 951 | 2,219 | ||||||
| Current portion of lease liability | 21 | - | ||||||
| Total current liabilities | 3,913 | 4,609 | ||||||
| Non-current liabilities | ||||||||
| Term loan | 25,000 | 25,000 | ||||||
| PIK interest | 937 | 260 | ||||||
| Debt discount | (298 | ) | (361 | ) | ||||
| Operating lease liability - net of current portion | 7 | - | ||||||
| Total non-current liabilities | 25,646 | 24,899 | ||||||
| Total liabilities | 29,559 | 29,508 | ||||||
| Shareholders'(deficit) equity: | ||||||||
| Common stock, no par value; unlimited shares authorized; 26,411 shares issued and outstanding (2022 -26,361) | 143,560 | 142,591 | ||||||
| Additional paid-in capital | 61,229 | 56,797 | ||||||
| Accumulated deficit | (216,563 | ) | (203,200 | ) | ||||
| Accumulated other comprehensive income | 1,243 | 1,243 | ||||||
| Total shareholders' (deficit) equity | (10,531 | ) | (2,569 | ) | ||||
| Total liabilities and shareholders' (deficit) equity | $ | 19,028 | $ | 26,939 |
| Working capital | Fiscal Period Ended | |||||||
| Selected Asset and Liability Data: | September 30, 2023 | December 31, 2022 | ||||||
| (U.S. Dollars in thousands) | ||||||||
| Cash and equivalents | $ | 12,399 | $ | 23,774 | ||||
| Other current assets | 6,547 | 2,954 | ||||||
| Current liabilities | (3,913 | ) | (4,608 | ) | ||||
| Working capital | $ | 15,033 | $ | 22,120 | ||||
| Selected Equity: | ||||||||
| Common stock and additional paid in capital | 204,789 | 199,388 | ||||||
| Accumulated deficit | (216,563 | ) | (203,200 | ) | ||||
| Shareholders' (deficit) equity | (10,531 | ) | (2,569 | ) |
Cisplatin-Induced Ototoxicity
and other platinum compounds are essential chemotherapeutic agents for the treatment of many pediatric malignancies. Unfortunately, platinum-based
therapies can cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric
of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids or cochlear
implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.ii
Infants and young children that are affected by ototoxicity at critical stages of development lack speech and language development and
literacy, and older children and adolescents often lack social-emotional development and educational achievement.iii
PEDMARK (sodium thiosulfate injection)
PEDMARK is the first and only
U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment
in pediatric patients with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use
vials for intravenous use in pediatric patients. PEDMARK is also the only therapeutic agent with proven efficacy and safety data with
an established dosing paradigm, across two open-label, randomized Phase 3 clinical studies, the Clinical Oncology Group (COG) Protocol
ACCL0431 and SIOPEL 6.
and Europe, it is estimated that, annually, more than 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.
has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG 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, medulloblastoma,
and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.
(sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month
of age and older with localized, non-metastatic solid tumors.
The safety and efficacy of PEDMARK have not been
established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered
following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.
Important Safety Information
PEDMARK is contraindicated in patients with history
of a severe hypersensitivity to sodium thiosulfate or any of its components.
Hypersensitivity reactions occurred in 8% to 13%
of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate
care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration
of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic
symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.
PEDMARK is not indicated for use in pediatric
patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.
Hypernatremia occurred in 12% to 26% of patients
in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or
4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK
in patients with baseline serum sodium greater than 145 mmol/L.
Monitor for signs and symptoms of hypernatremia
and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.
Administer antiemetics prior to each PEDMARK administration.
Provide additional antiemetics and supportive care as appropriate.
The most common adverse reactions ( 25% with
difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia.
The most common adverse reaction ( 25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.
Please see full Prescribing Information for PEDMARK
at: www.PEDMARK.com.
About Fennec Pharmaceuticals
Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of PEDMARK and
PedmarqsiTM to reduce the risk of platinum-induced ototoxicity in pediatric patients. Further, PEDMARK received FDA approval
in September 2022 and European Commission Marketing Authorization in June 2023 for Pedmarqsi. PEDMARK has received
Orphan Drug Exclusivity in the U.S. for seven years of market protection and Pedmarqsi has received Pediatric Use Marketing
Authorization in Europe which includes eight years plus two years of data and market protection. 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 reduction of risk of ototoxicity induced by platinum chemotherapy,
in humans. For more information, please visit www.fennecpharma.com.