生物医药系列产品
数据
资源
版本对比
免费注册
预约演示
免费注册
Fennec Pharmaceuticals
Announces First Quarter 2023 Financial Results and Provides Business Update
2023-05-11
·
BioSpace
上市批准
孤儿药
临床3期
引进/卖出
临床结果
Strong PEDMARK® Commercial Momentum Building in 2023 with Broad Payor and Medicaid Coverage PEDMARK® Permanent J-Code Effective April 1, 2023 Recent Positive CHMP Opinion in EU Recommending Approval of
PEDMARQSI
™ Company to Host Conference Call Today, Thursday, May 11 at 8:30 a.m. ET RESEARCH TRIANGLE PARK, N.C., May 11, 2023 (GLOBE NEWSWIRE) --
Fennec Pharmaceuticals Inc.
(NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today reported its financial results for the fiscal quarter ended March 31, 2023 and provided a business update. “During the first quarter, we continued to see strong commercial momentum and uptake of
PEDMARK
®, further underscoring the significant unmet medical need that exists for
pediatric solid tumor cancer
patients at risk for developing
hearing loss
associated with
cisplatin
treatment. Additionally, we are seeing significant commercial activity in the second quarter as a result of the relationships cultivated with healthcare providers and the
pediatric cancer
patient community by our commercial team since launch in October 2022,” said Rosty Raykov, chief executive officer of
Fennec Pharmaceuticals
. “We are pleased with the recent CHMP positive opinion for
PEDMARQSI
™ and the opportunity to expand PEDMARK’s presence and availability to patients in Europe.” Recent Developments and Highlights: Received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA)
recommending the approval of
PEDMARQSI
for reducing the risk of
cisplatin-induced hearing loss (Ototoxicity)
in pediatric patients with
localized, non-metastatic solid tumors
. Received notification that the U.S. Centers for Medicare & Medicaid Services (CMS) has issued a permanent J-Code (J0208) for PEDMARK, which became effective April 1, 2023 and will help facilitate the reimbursement process. Broad payor coverage in place with the largest commercial payors and Medicaid coverage in place across all fifty states. The National Comprehensive
Cancer
Network® (NCCN) updated its clinical practice guidelines for Adolescent and Young Adult (AYA) Oncology to include PEDMARK (
sodium thiosulfate
injection) in January 2023. The FDA granted Orphan Drug Exclusivity to PEDMARK (
sodium thiosulfate
injection) in January 2023. The FDA’s Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually. The seven-year market exclusivity for PEDMARK began on September 20, 2022, the date of its FDA approval, and continues until September 20, 2029. Additionally, in the approved prescribing label, the FDA has explicitly directed that
PEDMARK
® is not substitutable with other
sodium thiosulfate
products. Upcoming Investor Event Annual Meeting of Shareholders:
Fennec
would like to invite shareholders to attend its Annual General Meeting on Monday, June 12, 2023 at 10:00 a.m. ET, which will be held in person at The Nasdaq Market Site, New York, NY 10036, USA, or online by visiting . Financial Results for the First Quarter 2023 Cash Position – Cash and cash equivalents were $18.4 million at March 31, 2023 and $23.8 million at December 31, 2022. The decrease in cash and cash equivalents between March 31, 2023, and December 31, 2022, is the result of cash outlays for operating expenses related to the promotion of our product, small amounts of research and development and general and administrative expenses, which were offset by cash inflows from product sales. We anticipate that our cash, cash equivalents and investment securities as of March 31, 2023 will be sufficient to fund our planned operations for at least the next twelve months. Net Sales – The company recorded net product sales of $1.7 million in the first quarter of 2023. The Company recorded discounts and allowances against sales in the amount of $0.2 million and cost of products sold of $0.1 million. The Company had gross profit of $1.6 million for the first quarter of 2023. In the first quarter of 2022, the Company had no revenues. Research and Development (R&D) Expenses – Research and development expenses decreased by $1.4 million for the three months ended March 31, 2023, compared to the same period in 2022. The Company’s research and development activities for the first three months of 2023 consisted of costs associated with investigator initiated clinical trials. During the same period in 2022 and prior to approval of PEDMARK, manufacturing costs pertaining to PEDMARK were expensed to R&D expense in the period incurred, and following approval are reflected in inventory. Selling and Marketing Expenses – Selling and marketing expenses include remuneration of our sales and marketing employees, dollars spent on marketing campaigns (sponsorships, trade shows, presentations, etc.), and any activities to support marketing and sales activities. Selling and marketing expenses for the first quarter of 2023 was $2.5 million. General and Administrative (G&A) Expenses – G&A expenses increased by $2.2 million over the same period in 2022. Non-cash employee remuneration increased by $0.7 million over same period in 2022. Ongoing product support, professional and legal expenses and increased headcount accounted for the remaining increase. Net Loss – Net loss for the quarter ended March 31, 2023 was $6.1 million ($0.23 per share), compared to $3.7 million ($0.14 per share) for the same period in 2022. Q1 2023 CONFERENCE CALL INFORMATION The Company will host a conference call today, May 11, 2023, at 8:30 a.m. ET, to discuss the Company’s financial results from the first quarter, ended March 31, 2023, and provide a business outlook for the remainder of 2023. To access the conference call, please register via the following link: Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto 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 for thirty days. Financial Update 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 March 31, 2023 and management's discussion and analysis of financial condition and results of operations will be available via and 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 March 31, March 31, 2023 2022 Revenue PEDMARK product sales, net $ 1,677 $ — Cost of products sold (95 ) — Gross profit 1,582 — Operating expenses: Research and development 4 1,437 Selling and marketing 2,531 — General and administrative 4,317 2,109 Total operating expenses 6,852 3,546 Loss from operations (5,270 ) (3,546 ) Other (expense)/income Unrealized foreign exchange loss 9 (3 ) Amortization expense (72 ) (7 ) Unrealized loss on securities (30 ) (91 ) Interest income 109 9 Interest expense (798 ) (58 ) Total other (expense)/income (782 ) (150 ) Net loss $ (6,052 ) $ (3,696 ) Basic net loss per common share $ (0.23 ) $ (0.14 ) Diluted net loss per common share $ (0.23 ) $ (0.14 ) Weighted-average number of common shares outstanding basic 26,559 26,019 Weighted-average number of common shares outstanding diluted 26,559 26,019
Fennec Pharmaceuticals Inc.
Balance Sheets (U.S. Dollars in thousands) Unaudited Audited March 31, December 31, 2023 2022 Assets Current assets Cash and cash equivalents $ 18,390 $ 23,774 Accounts receivable, net 1,683 1,545 Prepaid expenses 639 770 Inventory 918 576 Other current assets 32 63 Total current assets 21,662 26,728 Non-current assets Deferred issuance cost, net amortization 159 211 Total non-current assets 159 211 Total assets $ 21,821 $ 26,939 Liabilities and shareholders’ (deficit) equity Current liabilities: Accounts payable $ 2,947 $ 2,390 Accrued liabilities 1,073 2,219 Total current liabilities 4,020 4,609 Long term liabilities Term loan 25,000 25,000 PIK interest 481 260 Debt discount (341 ) (361 ) Total long term liabilities 25,140 24,899 Total liabilities 29,160 29,508 Shareholders’(deficit) equity: Common stock, no par value; unlimited shares authorized; 26,412 shares issued and outstanding (2022 ‑26,361) 142,804 142,591 Additional paid-in capital 57,866 56,797 Accumulated deficit (209,252 ) (203,200 ) Accumulated other comprehensive income 1,243 1,243 Total shareholders’ (deficit) equity (7,339 ) (2,569 ) Total liabilities and shareholders’ (deficit) equity $ 21,821 $ 26,939 Working Capital Working capital Fiscal Period Ended Selected Asset and Liability Data: March 31, 2023 December 31, 2022 (U.S. Dollars in thousands) Cash and equivalents $ 18,390 $ 23,774 Other current assets 3,272 2,954 Current liabilities 4,020 4,608 Working capital $ 17,642 $ 22,120 Selected Equity: Common stock and additional paid in capital 200,670 199,388 Accumulated deficit (209,252 ) (203,200 ) Shareholders’ equity (7,339 ) (2,569 ) About
Cisplatin-Induced Ototoxicity
Cisplatin
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 cancer.i The incidence 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. In the U.S. 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. PEDMARK 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
. Indications and Usage
PEDMARK
® (
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
. Limitations of Use 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: . About
Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc.
is a specialty pharmaceutical company focused on the development and commercialization of
PEDMARK
® to reduce the risk of
platinum-induced ototoxicity
in pediatric patients. Further, PEDMARK received FDA approval in September 2022 and has received Orphan Drug Exclusivity in the U.S.
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 . 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 statements about our business strategy, timeline and other goals, plans and prospects, including our commercialization plans respecting PEDMARK®, the market opportunity for and market impact of
PEDMARK
®, its potential impact on patients and anticipated benefits associated with its use, and potential access to further funding after the date of this release. 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 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, 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, our ability to obtain necessary capital when needed on acceptable terms or at all, 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, 2022.
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 and . PEDMARK® and
Fennec
® are registered trademarks of
Fennec Pharmaceuticals Inc.
©2023
Fennec Pharmaceuticals Inc.
All rights reserved. FEN-1604-v1 Investors: Robert Andrade Chief Financial Officer
Fennec Pharmaceuticals Inc.
+1 919-246-5299 Corporate and Media: Lindsay Rocco Elixir Health Public Relations +1 862-596-1304 lrocco@elixirhealthpr.com i Rybak L. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection. Current Opinion in Otolaryngology & Head and Neck Surgery. 2007, Vol. 15: 364-369. ii Landier W. Ototoxicity and
Cancer
Therapy. Cancer. June 2016 Vol. 122, No.11: 1647-1658. iii Bass JK, Knight KR, Yock TI, et al. Evaluation and Management of
Hearing Loss
in Survivors of
Childhood and Adolescent Cancers
: A Report from the Children's Oncology Group. Pediatric Blood &
Cancer
. 2016 Jul;63(7):1152-1162.
更多内容,
请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点,如有版权侵扰或错误之处,请及时联系我们,我们会在24小时内配合处理。
机构
Fennec Pharmaceuticals, Inc.
The European Medicines Agency
US Food & Drug Administration
[+1]
适应症
肉瘤
生殖细胞癌
实体瘤
[+15]
靶点
-
药物
硫代硫酸钠
顺铂
GBP-1a
[+1]
标准版
¥
16800
元/账号/年
新药情报库 | 省钱又好用!
立即使用
来和芽仔聊天吧
热门报告
特应性皮炎深度解析:药物开发、专利分析与风险评估
智慧芽生物医药
2024年7月全球首批及特殊审评药物报告
智慧芽生物医药
GPRC5D靶点专利调研报告
智慧芽生物医药
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台,助您全方位提升您的研发与决策效率。
开始免费试用
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台,以API或者数据包形式对外开放,助您更加充分利用智慧芽新药情报信息。
试用数据服务