Neuroblastoma

Agreement pairs Norgine’s commercial expertise and leading European footprint with PEDMARQSI®, the first and only approved therapy in the European Union and U.K. for reducing the risk of cisplatin-induced hearing loss in pediatric patients with localized, non-metastatic solid tumors Fennec will receive €40 million in upfront and up to €210 million in additional commercial and regulatory milestones, and tiered royalties up to the mid-twenties Enhances Norgine’s commitment to bringing transformative therapies to patients in Europe, U.K., Australia, and New Zealand who currently do not have access to a therapy to treat this life altering condition RESEARCH TRIANGLE PARK, N.C. and UXBRIDGE, United Kingdom, March 17, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, and Norgine, a leading European specialist pharmaceutical company, today announced an exclusive licensing agreement under which Norgine will commercialize PEDMARQSI® in Europe, Australia and New Zealand. PEDMARQSI is the first and only approved therapy in the EU and U.K. for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localized, non-metastatic solid tumors. Under the terms of the licensing agreement, Fennec will receive €40 million in upfront consideration and up to €210 million in additional commercial and regulatory milestone payments and double-digit tiered royalties on net sales of PEDMARQSI in the licensed territories up to the mid-twenties. Norgine will be responsible for all commercialization activities in the licensed territories and will hold all marketing authorizations in the licensed territories. It is estimated that more than 5,000 pediatric patients annually are eligible for platinum-based chemotherapy in Europe. PEDMARQSI was granted EU marketing authorization by the European Commission in June 2023, and received UK approval from the MHRA in October 2023. Approvals were based on safety and efficacy data from two open-label, randomized Phase 3 trials, SIOPEL 6 (pivotal) and Clinical Oncology Group [COG] Protocol ACCL0431. The studies compared PEDMARQSI plus cisplatin-based regimens to cisplatin-based regimens alone for the reduction of cisplatin-induced hearing loss in pediatric patients. PEDMARQSI holds eight years plus two years of data and market protection in Europe based on its Pediatric Use Marketing Authorization. Approval in Switzerland, Australia and New Zealand will also be pursued. The first study (SIOPEL-6) involved 114 children with hepatoblastoma (a cancer of the liver), with an average age of about 19 months. The results showed that 35% (20 out of 57) of children who received PEDMARQSI 6 hours after each dose of cisplatin developed hearing loss compared with 67% (35 out of 52) of children who only received cisplatin. The second study involved 125 children aged 1 month to 18 years with different types of cancer, including hepatoblastoma, neuroblastoma (a cancer of immature nerve cells) and tumours of the central nervous system. The study found that hearing loss was experienced by 29% (14 out of 49) of children who received PEDMARQSI after each cisplatin dose compared with 56% (31 out of 55) of those who received only cisplatin. “We are delighted to partner with Norgine, who shares our belief in the potential of PEDMARQSI to mitigate the risk of permanent and irreversible hearing loss that can occur in pediatric patients treated with cisplatin. Further, this partnership is an important step in achieving our mission of expanding PEDMARQSI to patients across the globe who are at risk of suffering from cisplatin-induced ototoxicity,” said Rosty Raykov, Chief Executive Officer of Fennec Pharmaceuticals. “From a deal perspective, the terms provided us many important benefits, including an upfront payment further solidifying our balance sheet, attractive economic terms providing meaningful participation in the ex-US success of PEDMARQSI and an experienced partner to successfully launch PEDMARQSI in the licensed territory.” Chris Bath, Chief Executive Officer of Norgine, said, “We are thrilled to announce our partnership with Fennec, to bring this vital medicine to pediatric patients who are being treated with cisplatin, across Europe and ANZ. We look forward to working with the Fennec team and launching PEDMARQSI in our territories in the coming months, establishing it as the standard of care in this critical patient population with high unmet need. This important milestone for our company builds on our 30-year track record of creating partnerships of enduring value and further underscores Norgine’s position as the specialty pharma partner of choice across Europe and ANZ.” Moelis & Company LLC acted as financial advisor, and LaBarge Weinstein LLP acted as legal advisor to Fennec. Arnold & Porter acted as legal advisor to Norgine. About Fennec Pharmaceuticals Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of PEDMARK® and PEDMARQSI® to reduce the risk of platinum-induced ototoxicity in pediatric patients. PEDMARK received FDA approval in September 2022 and European Commission Marketing Authorization in June 2023 for PEDMARQSI. Further, PEDMARQSI received U.K. approval in October 2023. 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. For more information, please visit www.fennecpharma.com. About Norgine Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Commitment to transforming people’s lives drives everything Norgine does with fully integrated infrastructure and exceptional partnership approach enabling creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped more than 25 million patients annually around the world and generated over €500 million in net product sales in 2023. Norgine has a direct presence in 18 European countries, as well as Australia and New Zealand and has a strong global network of partnerships in non-Norgine markets. Norgine possesses a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to sales and marketing infrastructure. NORGINE and the sail logo are trademarks of the Norgine group of companies. 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® and PEDMARQSI®, the market opportunity for and market impact of PEDMARK and PEDMARQSI, 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 www.sec.gov and www.sedar.com. PEDMARK®, PEDMARQSI® and Fennec® are registered trademarks of Fennec Pharmaceuticals Inc. Fennec Contacts: Investors:Robert AndradeChief Financial OfficerFennec Pharmaceuticals Inc.+1 919-246-5299 Media:Lindsay RoccoElixir Health Public Relations+1 862-596-1304 Norgine Contacts: Matilde CorucheChief People Officercontact@norgine.com

NEW YORK, March 14, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced that Chief Financial Officer, Bo Kruse, has notified the Company of his resignation. Y-mAbs has commenced a search process for a successor. Mr. Kruse will remain in the Chief Financial Officer role until his successor is identified and joins the Company. He will then continue as a non-executive employee from the time his successor joins the Company through July 31, 2024, after which it is expected that Mr. Kruse will be available to the Company for a period of time to support a smooth transition of the Chief Financial Officer role. “Bo joined at Y-mAbs’ inception and has served as a dedicated financial steward throughout the company’s remarkable growth journey,” said Michael Rossi, President and Chief Executive Officer. “He has been a valued member of our leadership team. Through his responsible capital management, Bo will be leaving Y-mAbs in a strong position as we continue our mission of providing better and safer cancer therapies to patients. On behalf of the Board and the entire team at Y-mAbs, I want to thank Bo for his leadership and commitment to this company. We wish him the best in all his future endeavors.” “I am grateful for Bo’s executive partnership and dedication to Y-mAbs over the last nine years,” said Thomas Gad, Founder, Vice Chairman of the Board of Directors and Chief Business Officer. “Bo played an important role in building what Y-mAbs is today, a financially independent commercial-stage company with an exciting future ahead. We respect Bo’s decision and, with his support, anticipate effecting a smooth transition as we identify and onboard a new Chief Financial Officer.” “It has been an honor and a privilege to serve as Chief Financial Officer of Y-mAbs since its founding in April 2015,” said Mr. Kruse. “While I believe now is the time for a new venture, I have confidence in Y-mAbs’ plans for DANYELZA and the continued advancement of its novel pretargeted radioimmunotherapy technology platform and programs through clinical development. I look forward to following the company’s success.” About Y-mAbs Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, radioimmunotherapy and antibody-based therapeutic cancer products. The Company’s technologies include its investigational Self-Assembly DisAssembly (“SADA”) ​Pretargeted Radioimmunotherapy Platform (“PRIT”)​ and bispecific antibodies generated using the Y-BiClone platform. The Company’s broad and advanced product pipeline includes the anti-GD2 therapy DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after a partial response, minor response, or stable disease to prior therapy. Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, implied and express statements regarding the future of the Company’s business, including with respect to expansion and its goals; the Company’s plans and strategies, development, commercialization and product distribution plans; expectations with respect to the Company’s products and product candidates, including potential benefits thereof, and the potential of the SADA Technology and potential benefits and applications thereof; statements with respect to SADA as a differentiated radioimmunotherapy platform; expectations relating to the SADA Technology, including expectations with respect to current and future clinical and pre-clinical studies and the Company’s research and development programs; expectations that the Company will continue to advance novel oncology therapies and its lead clinical programs to provide better and safer cancer therapies to patients; statements about the transition of the Company’s chief financial officer role and identification and commencement of a successor chief financial officer; and other statements that are not historical facts. Words such as ‘‘anticipate,’’ ‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ “hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ “will”, ‘‘would’’, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company’s financial condition and need for additional capital; the risks that actual results of the Company’s restructuring plan and revised business plan will not be as expected; risks associated with the Company’s development work; cost and success of the Company’s product development activities and clinical trials; the risks of delay in the timing of the Company’s regulatory submissions or failure to receive approval of its drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of product candidates; development of sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for products; the risks related to the Company’s dependence on third parties including for conduct of clinical testing and product manufacture; the Company’s inability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of the Company’s intellectual property rights; risks related to employee matters and managing growth; risks related to the Company’s common stock, risks associated with macroeconomic conditions, including the conflict between Russia and Ukraine and sanctions related thereto, the state of war between Israel and Hamas and the related risk of a larger conflict, inflation, increased interest rates, uncertain global credit and capital markets and disruptions in banking systems; and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and future filings and reports by the Company. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. DANYELZA® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc. Investor Contact: Courtney Dugan VP, Head of Investor Relations cdu@ymabs.com

MINNEAPOLIS, March 12, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics Inc. (Nasdaq: PBLA), (“Panbela”), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced that it will host a conference call on March 26, 2024, at 4:30 PM Eastern Time to discuss results for its fourth quarter and year ended December 31, 2023. Conference Call Information Toll Free: 888-506-0062 International: 973-528-0011 Participant Access Code: 195310 Webcast Link: Conference Call Replay Information Toll Free: 877-481-4010 International: 919-882-2331 Replay Passcode: 49978 Webcast Replay: About Panbela’s Pipeline The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of anticipated catalysts with programs ranging from pre-clinical to registration studies. Ivospemin (SBP-101) Ivospemin is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both exceeding what is typical for the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, ivospemin has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI pro in the previous Panbela-sponsored clinical trials provide support for continued evaluation of ivospemin in the ASPIRE trial. Flynpovi ™ Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a Phase III clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase III trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety pro Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP. CPP-1X CPP-1X (eflornithine) is being developed as a single agent tablet or high dose powder sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase I or Phase II investigator-initiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity. About Panbela Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for patients with urgent unmet medical needs. Panbela’s lead assets are Ivospemin (SBP-101) and Flynpovi. Further information can be found at . Panbela’s common stock is listed on The Nasdaq Stock Market LLC under the symbol “PBLA”. Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements,” including within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “believe,” “can,” “design,” “expect,” “focus,” “intend,” “looking forward,” “may,” “plan,” “positioned,” “potential,” and “will.” All statements other than statements of historical fact are statements that should be deemed forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially and adversely from the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) our ability to obtain additional funding to execute our business and clinical development plans; (ii) progress and success of our clinical development program; (iii) the impact of the current COVID-19 pandemic on our ability to conduct our clinical trials; (iv) our ability to demonstrate the safety and effectiveness of our product candidates: ivospemin (SBP-101) and eflornithine (CPP-1X); (v) our reliance on a third party for the execution of the registration trial for our product candidate Flynpovi ; (vi) our ability to obtain regulatory approvals for our product candidates, SBP-101 and CPP-1X in the United States, the European Union or other international markets; (vii) the market acceptance and level of future sales of our product candidates, SBP-101 and CPP-1X; (viii) the cost and delays in product development that may result from changes in regulatory oversight applicable to our product candidates, SBP-101 and CPP-1X; (ix) the rate of progress in establishing reimbursement arrangements with third-party payors; (x) the effect of competing technological and market developments; (xi) the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims; (xii) our ability to maintain the listing of our common stock on a national securities exchange; and (xiii) such other factors as discussed in Part I, Item 1A under the caption “Risk Factors” in our most recent Annual Report on Form 10-K, any additional risks presented in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Any forward-looking statement made by us in this press release is based on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement or reasons why actual results would differ from those anticipated in any such forward-looking statement, whether written or oral, whether as a result of new information, future developments or otherwise. Contact Information: Investors: James Carbonara Hayden IR (646) 755-7412 james@haydenir.com Media: Tammy Groene Panbela Therapeutics, Inc. (952) 479-1196 IR@panbela.com