FENC

Fennec Pharmaceuticals Inc. (NASDAQ:FENC) shares jumped 7.88% in pre-market trading on Tuesday after the specialty pharmaceutical company reported second-quarter earnings and revenue above analyst expectations, supported by continued growth in PEDMARK sales. Adjusted earnings came in at $0.05 per share, exceeding the analyst consensus of $0.02 by $0.03. Revenue reached $17.87 million, ahead of the $16.39 million forecast. The results extended the company’s recent growth momentum and showed a significant improvement in adjusted profitability compared with the same quarter last year. Net product sales increased to $17.1 million from $9.7 million in the second quarter of 2025, representing year-on-year growth of 78%. Fennec attributed the increase to stronger demand for PEDMARK across both new and existing accounts, as well as expansion into the adolescent and young adult population. The quarter was also the first full reporting period since Fennec expanded its commercial organisation, giving investors an early indication of how the larger sales operation is contributing to product growth. “Our second quarter reflects another period of strong execution across the business, highlighted by our seventh consecutive quarter of growth,” said Jeff Hackman, chief executive officer of Fennec Pharmaceuticals. “As evidenced in our record EBITDA generation in the second quarter, we have a highly effective business model that is primed to optimize our anticipated growth while advancing our mission to improve outcomes for patients.” Improving sales translated into a substantial change in Fennec’s adjusted profitability. Adjusted EBITDA reached $2.8 million in the second quarter, compared with an adjusted EBITDA loss of $1.2 million in the same period of 2025. The swing into positive adjusted EBITDA provides another measure of the operating leverage emerging as PEDMARK revenue expands, although investment in commercial growth also increased significantly. Selling and marketing expenses climbed to $10.7 million from $4.8 million a year earlier, primarily reflecting higher commercialisation costs and the expanded sales organisation. General and administrative expenses moved in the opposite direction, declining to $4.6 million from $6.5 million due mainly to lower legal and professional fees. Fennec ended June with $41.2 million in cash and cash equivalents, up from $40.1 million at the end of the first quarter. For investors, the combination of a Q2 earnings beat, 78% product sales growth and a move into positive adjusted EBITDA provides evidence that increased PEDMARK demand is translating into stronger financial performance. The next key measure will be whether Fennec can sustain that sales momentum while absorbing the higher commercial spending associated with its expanded organisation. Fennec Pharmaceuticals stock price

This article first appeared on GuruFocus. Net Product Sales: $17.1 million in Q2 2026, up approximately 78% year-over-year from $9.7 million in Q2 2025. Operating Expenses (OpEx): Approximately $13.6 million for Q2 2026, a year-over-year increase of about $3.6 million, driven by expanded marketing and commercial headcount. Non-GAAP Adjusted EBITDA: Record $2.8 million in Q2 2026, compared to a loss of $1.2 million in Q2 2025. Earnings Per Share (EPS): $0.05 per share in Q2 2026, compared to a loss of $0.11 per share in the prior-year quarter. Cash and Cash Equivalents: $41.2 million as of June 30, 2026, with a $1 million increase during the quarter. 2026 Cash OpEx Guidance: Expected to be approximately $50 million, with $20 million to $22 million (40%) to be recorded in the second half of 2026. Warning! GuruFocus has detected 5 Warning Signs with ELVA. Is FENC fairly valued? Test your thesis with our free DCF calculator. Release Date: August 11, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Record Q2 2026 net product sales of $17.1 million, a 78% year-over-year increase, driven by strong demand and a 143% revenue increase since 2024. Achieved seventh consecutive quarter of growth, with record patient enrollment, infusions, and new customers in July 2026, indicating sustained momentum. Expanded commercial reach with a 280% increase in sales calls and a target base growth from 1,300 to 5,000 prescribers, enhancing market penetration. Positive clinical and regulatory progress, including NCCN 2A recommendation for AYA patients, multiple investigator-sponsored studies (ISTs) across tumor types, and an oral presentation at SIOP 2026 for PEDMARK's pharmacokinetic data. Strong financial position with $41.2 million in cash, record non-GAAP adjusted EBITDA of $2.8 million, and a positive EPS of $0.05, reflecting improved profitability and cash flow. No formal revenue guidance provided for 2026, with management only hinting at potential guidance for 2027, leaving investors without clear forward-looking targets. Expected Q3 2026 cash position to be lower than Q2 due to collection cycles, indicating potential short-term cash flow volatility. Dependence on investigator-sponsored studies (ISTs) for label expansion and NCCN guideline updates, which are subject to enrollment timelines and regulatory approval, creating uncertainty. Increased operating expenses, with a $3.6 million year-over-year rise in OpEx, driven by marketing and headcount investments, which may pressure near-term profitability. Limited progress on in-licensing complementary products, with management noting no suitable opportunities yet, potentially limiting portfolio diversification and long-term growth. Q: Can you provide an update on the productivity ramp of the newly expanded sales force and their contribution to Q2 growth? A: Jeff Hackman (CEO) noted that the expanded team, now targeting nearly 5,000 prescribers, is already having a significant impact, with new patients coming from regions previously untapped. Terry Evans (CCO) added that the new reps are "adding to the success" and are on a growth curve, having started in early March. The company highlighted that July set all-time highs for completed infusions, patient enrollments, and active patients, indicating the new reps are still ramping up. Q: Given the record demand and sequential growth acceleration, should we expect the business to accelerate further in the second half of 2026? A: Jeff Hackman (CEO) confirmed that the momentum is continuing, with July being a record month following a record April. He expects this significant growth to continue through Q3 and into Q4. Robert Andrade (CFO) echoed this, stating that the productivity curve is expected to ramp up and that the company is "quite pleased" with its position in the current quarter, though he declined to provide specific growth figures. Q: What is the current patient mix by tumor type, and how does the split between academic and community oncology settings look? A: Terry Evans (CCO) stated that over 80% of the business comes from testicular, cervical, and head and neck cancers, with testicular cancer being the largest driver. He noted a "really nice balanced approach" between academic and community settings, with both growing nicely due to the expanded sales force and recent formulary wins in the community. Q: What is the company's strategy for lifecycle management and expanding the label for PEDMARK? A: Pierre Sayad (CMO) explained that the strategy is multi-pronged, driven by data from the three active investigator-sponsored trials (ISTs) at City of Hope, University of Arizona, and Tampa General Hospital. As data matures, they are in discussions with regulatory agencies for potential label expansion and are also looking at opportunities to strengthen NCCN guideline recommendations across various tumor types. Q: When might the company be in a position to provide formal revenue guidance, and what is the timeline for a potential shift in NCCN guideline classification? A: Jeff Hackman (CEO) reiterated that the company does not provide formal guidance but is considering the possibility for 2027 as the business grows. Regarding NCCN, Pierre Sayad (CMO) stated they have a focused strategy to take data to different NCCN boards (head and neck, gyn-onc, testicular) once the data matures, emphasizing a "data first" approach. Q: Can you provide an update on the progress of the investigator-sponsored studies (ISTs) and the enrollment pace? A: Pierre Sayad (CMO) stated that while the company cannot interfere with IST accruals for compliance reasons, they have helped drive awareness within each institution's network. He expressed encouragement with the early enrollment numbers and noted an "abundance of increased interest" in additional ISTs across different tumor types, patient ages, and disease stages. Q: What is the status of the launch preparations and partnership strategy for PEDMARK in Japan? A: Jeff Hackman (CEO) stated they are encouraged by ongoing discussions with potential partners in Japan. He and Pierre Sayad (CMO) are scheduled to visit Japan to meet with their team and potential partners. The focus is on finding the right path forward for the product in Japan and the broader Asia-Pacific region, aiming to maximize long-term value while getting the product approved as quickly as possible. Q: Has there been any evolution in strategic thinking regarding in-licensing complementary products for the sales force? A: Jeff Hackman (CEO) confirmed that the company is actively evaluating opportunities to add complementary products to the commercial portfolio. He noted that the team's strong execution has created an opportunity to "put something else in their bag," and while they have not found the right fit yet, they remain open to discussions. Q: Can you elaborate on the impact of the "Indy's Nuts" disease awareness campaign and the presence at ASCO? A: Christi Cioffi (CSO) detailed the campaign's success, which launched at the Indianapolis 500 with the distribution of over 100,000 bags of peanuts. The campaign exceeded industry norms in several performance metrics. At ASCO, the "Fennec Speedway" exhibit generated exceptional engagement, was featured in Fierce Pharma, and generated hundreds of HCP leads, validating the company's strategy to educate beyond traditional healthcare settings. Q: What were the key drivers of the strong Q2 financial results, and what is the outlook for cash and EBITDA? A: Robert Andrade (CFO) reported net product sales of $17.1 million, a 78% increase year-over-year, driven by record patient enrollment. The company posted record non-GAAP adjusted EBITDA of $2.8 million. He reiterated the expectation of approximately $50 million in total cash OpEx for 2026, with 40% to be recorded in H2. While Q3 ending cash is expected to be lower due to collection cycles, the company anticipates positive cash generation in Q4 and a positive year-end cash position. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

~ 2026 Second Quarter Net Product Sales of $17.1 Million, Up 78% Year over Year ~ ~ 2026 Second Quarter Non-GAAP Adjusted EBITDA of $2.8 Million ~ ~ Record PEDMARK® Demand Carried into Third Quarter 2026 as Field Sales Expansion Efforts Continue to Validate Commercial Growth Strategy ~ ~ Real-World Evidence Presented at ASCO 2026 Reinforced that PEDMARK® Can Be Easily Integrated into Patient Care and Does Not Compromise Cisplatin’s Established Antitumor Activity ~ ~ Management to Host Conference Call Today at 8:30 a.m. ET ~ RESEARCH TRIANGLE PARK, N.C., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today reported its financial results for the second quarter ended June 30, 2026 and provided a business update. “Our second quarter reflects another period of strong execution across the business, highlighted by our seventh consecutive quarter of growth. We continue to build momentum by investing in the evidence that will shape the future of PEDMARK® (sodium thiosulfate), with important data presented at ASCO and a growing pipeline of investigator-sponsored studies that we believe will further expand our understanding of its potential,” said Jeff Hackman, chief executive officer of Fennec Pharmaceuticals. “As evidenced in our record EBITDA generation in the second quarter, we have a highly effective business model that is primed to optimize our anticipated growth while advancing our mission to improve outcomes for patients.” Business Highlights: Continued Commercial Momentum Within Key PEDMARK® Accounts: The first full quarter following the expansion of our commercial organization contributed to unprecedented enrollment in the second quarter. Through disciplined execution and now greater reach and frequency to engage with healthcare providers, demand grew across both new and existing accounts, further demonstrating the scalability of our commercial platform. Our commercial, patient services, and medical affairs teams continue to work closely together to help ensure a positive PEDMARK® experience for both prescribers and patients throughout the treatment journey. 2026 American Society of Clinical Oncology (ASCO) Annual Meeting: New research evaluating PEDMARK® across multiple patient populations and tumor types were shared as part of the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting program. The four independently led studies build upon the established safety and efficacy of PEDMARK® – currently approved for pediatric patients one month of age and older with localized, non-metastatic solid tumors, and recognized by the National Comprehensive Cancer Network with a 2A recommendation for use in adolescent and young adult patients – and help to expand understanding of the clinical utility of PEDMARK® in Adolescent and Young Adult (AYA) and adult populations, where significant unmet need remains. Upcoming Events: H.C. Wainwright 27th Annual Global Investment Conference: Fennec will present at the conference to be held September 14 – 17, 2026, in NYC. The management team will also host one-on-one investor meetings at the conference. Financial Results for the Second Quarter Ended June 30, 2026 Net Product Sales – For the second quarter of 2026, the Company recorded net product sales of approximately $17.1 million compared to $9.7 million in the second quarter of 2025. The increase in sales is attributable to growth across PEDMARK® accounts including new accounts in the AYA population. Selling and Marketing Expenses – The Company recorded $10.7 million in selling and marketing expenses in the second quarter of 2026 compared to $4.8 million in the second quarter of 2025. The increase is largely related to is largely related to the higher costs associated with the commercialization and increased awareness initiatives of PEDMARK® and related expenses to support the expansion of our sales organization. Further, on a comparable basis, there was a reallocation of select general and administrative expenses to selling and marketing expenses in the second quarter of 2026 compared to the second quarter of 2025. General and Administrative (G&A) Expenses – The Company recorded $4.6 million in general and administrative expenses in the second quarter of 2026 compared to $6.5 million in the second quarter of 2025. Thedecrease in general and administrative expenses for the three-month comparable periods due to lower legal and professional fees as select litigation activities concluded. Further, on a comparable basis, there was a reallocation of select general and administrative expenses to selling and marketing expenses in the second quarter of 2026 compared to the second quarter of 2025. Non-GAAP adjusted EBITDA – The Company recorded $2.8 million in non-GAAP adjusted EBITDA in the second quarter of 2026 compared to non-GAAP adjusted EBITDA loss of $1.2 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference. Cash Position – Cash and cash equivalents were $41.2 million as of June 30, 2026 compared to $40.1 million as of March 31, 2026. We anticipate that our cash, cash equivalents and investment securities as of June 30, 2026, combined with the projected revenues from PEDMARK®, will be sufficient to fund our business based on our current operating plan. Second Quarter 2026 Conference Call Information Date: Tuesday, August 11, 2026Time: 8:30 a.m. Eastern TimeWebcast Link: https://edge.media-server.com/mmc/p/2iptdco4 Participant Link: https://register-conf.media-server.com/register/BIaa4b518aeb974d02873eccf8f56d92f3 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 June 30, 2026, 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. About Cisplatin-Induced OtotoxicityCisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates. Unfortunately, these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity.1 Hearing loss from cisplatin treatment is not rare. Studies show that between 60-90% of patients treated with cisplatin may develop hearing loss, depending upon the dose and duration of chemotherapy.2 Many of those treated with cisplatin will 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.3 Treatment-induced hearing loss can reduce quality of survivorship as it impacts many aspects of life, such as speech and language skills, academic performance, social-emotional development, career potential and the ability to live independently.4,5 While audiologic monitoring is recommended to help manage ototoxicity, it is currently underutilized in certain cancer patient populations. 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 1 month of age and older 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 first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6. Additionally, PEDMARK® is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement. Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy.6,7 The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss.8,9 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 UsagePEDMARK® (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 UseThe 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 InformationPEDMARK 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 PharmaceuticalsFennec Pharmaceuticals Inc. is a specialty pharmaceutical company committed to the fight against ototoxicity in cancer patients who receive cisplatin-based chemotherapy. Fennec is focused on the commercialization of PEDMARK® to reduce the risk of platinum-induced ototoxicity in cancer patients. PEDMARK received FDA approval in September 2022 and European Commission approval in June 2023 and United Kingdom (U.K.) approval in October 2023 under the brand name PEDMARQSIÒ. In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, will commercialize PEDMARQSI® in Europe, U.K., Australia and New Zealand. PEDMARQSI is now commercially available in multiple countries. PEDMARK has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. Further, Fennec has patents providing protection for PEDMARK until 2039 in both the U.S. and internationally. For more information, please visit www.fennecpharma.com and follow on LinkedIn. Forward Looking StatementsExcept 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, business model, timelines and other goals, plans and prospects, including our commercialization plans respecting PEDMARK®/PEDMARQSI®, the market opportunity for and market impact of PEDMARK®/ PEDMARQSI®, its potential impact on patients and anticipated benefits associated with its use, future commercial and regulatory milestone and royalty payments from Norgine, anticipated growth, and the sufficiency of our current financial resources. . 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 or future demand 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, 2025. 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. ©2025 Fennec Pharmaceuticals Inc. All rights reserved. For further information, please contact: Investors:Robert AndradeChief Financial OfficerFennec Pharmaceuticals Inc.+1 919-246-5299 Corporate and Media:Lindsay Rocco Elixir Health Public Relations+1 [email protected] ___________________________________1 Sheth S et al. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection. Frontiers in Cellular Neuroscience. 2017, Vol. 11.2 Langer T, am Zehnhoff-Dinnesen A, Radtke S, Meitert J, Zolk O. Understanding platinum-induced ototoxicity. Trends Pharmacol Sci. 2013;34(8):458-4693 Landier W. Ototoxicity and Cancer Therapy. Cancer. June 2016 Vol. 122, No.11: 1647-1658.4 Clemens E, van den Heuvel-Eibrink MM, Mulder RL, et al. Recommendations for ototoxicity surveillance for childhood, adolescent, and young adult cancer survivors: a report from the International Late Effects of Childhood Cancer Guideline Harmonization Group in collaboration with the PanCare Consortium. Lancet Oncol. 2019;20(1):e29-e415 Bass JK, Knight KR, Yock TI, Chang KW, Cipkala D, Grewal SS. Evaluation and management of hearing loss in survivors of childhood and adolescent cancers: a report from the children’s oncology group. Pediatr Blood Cancer. 2016;63(7):1152-1162.6 Chattaraj A et al. Cisplatin-Induced Ototoxicity: A Concise Review of the Burden, Prevention, and Interception Strategies. JCO Oncol Pract. 2023;197 Freyer DR et al. Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017;18(1):63-74.8 Rajput K, Edwards L, Brock P, Abiodun A, Simpkin P, Al-Malky G. Ototoxicity-induced hearing loss and quality of life in survivors of paediatric cancer. Int J Pediatr Otorhinolaryngol. 2020;138:110401. doi:10.1016/j.ijporl.2020.1104019 Bass JK, Knight KR, Yock TI, Chang KW, Cipkala D, Grewal SS. Evaluation and management of hearing loss in survivors of childhood and adolescent cancers: a report from the children’s oncology group. Pediatr Blood Cancer. 2016;63(7):1152-1162.

Adherex Technologies Inc. (FENC) came out with quarterly earnings of $0.05 per share, beating the Zacks Consensus Estimate of $0.01 per share. This compares to a loss of $0.11 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +400.00%. A quarter ago, it was expected that this company would post a loss of $0.02 per share when it actually produced earnings of $0.01, delivering a surprise of +150%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Adherex Technologies, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $17.87 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 11.73%. This compares to year-ago revenues of $9.65 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Adherex Technologies shares have added about 42.1% since the beginning of the year versus the S&P 500's gain of 13.3%. While Adherex Technologies has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Adherex Technologies was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.11 on $18.48 million in revenues for the coming quarter and $0.26 on $69.89 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 39% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, MaxCyte, Inc. (MXCT), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 12. This company is expected to post quarterly loss of $0.12 per share in its upcoming report, which represents no change from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 14.3% lower over the last 30 days to the current level. MaxCyte, Inc.'s revenues are expected to be $6.5 million, down 23.6% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Adherex Technologies Inc. (FENC) : Free Stock Analysis Report MaxCyte, Inc. (MXCT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Interested in Adherex Technologies Inc.? Here are five stocks we like better. Strong PEDMARK growth: Second-quarter net product sales rose 78% year over year to $17.1 million, marking the company’s seventh consecutive quarter of growth. Expanded sales coverage, increased enrollments and record infusions drove demand. Improved profitability and cash outlook: Adjusted EBITDA reached $2.8 million versus a $1.2 million loss a year earlier, while EPS improved to $0.05. Fennec held $41.2 million in cash and expects positive cash generation in the fourth quarter and at year-end. Broader clinical and commercial expansion: Fennec increased healthcare-professional outreach, launched an additional investigator-sponsored study and expects first human pharmacokinetic data from its Japanese STS-J01 trial in September. The company is also evaluating complementary business-development opportunities and potential Japan partnerships. Adherex Technologies (NASDAQ:FENC), operating as Fennec Pharmaceuticals, reported second-quarter 2026 net product sales of $17.1 million, up approximately 78% from $9.7 million in the prior-year period, as demand for its PEDMARK therapy continued to rise. Chief Executive Officer Jeff Hackman said the company recorded its seventh consecutive quarter of growth and has expanded its customer-facing organization from approximately 1,300 prescriber targets to roughly 5,000. Since he joined the company two years ago, Hackman said revenue has increased 143% through expanded commercial reach, clinical-evidence efforts and additional hiring. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat PEDMARK is approved for pediatric patients one month and older with localized, non-metastatic solid tumors. The therapy is also recognized by the National Comprehensive Cancer Network with a Category 2A recommendation for use in adolescent and young adult, or AYA, patients, according to the company. Chief Commercial Officer Terry Evans said Fennec’s expanded field sales force made 280% more sales calls in the second quarter than a year earlier. Demand rose by double digits from the first quarter, with patient enrollments through the Fennec HEARS services hub contributing to a quarterly record for PEDMARK infusions. → 3 Dividend Champion Utilities for a Market That Can't Sit Still Evans said the company also recorded a record number of AYA enrollments during the quarter. More than half of Fennec’s business came through home infusion centers, which offer flexible scheduling for patients and providers. In July, Fennec reported monthly records for completed PEDMARK infusions, new patient enrollments, active patients receiving therapy and new customers. Hackman said the company was continuing to see momentum early in August but did not provide a quantitative revenue outlook. → Take-Two’s Q1 Results Leave GTA 6 Bulls Stuck in the Fog of War During the question-and-answer session, Evans said more than 80% of current business is tied to testicular, cervical and head-and-neck cancers, with testicular cancer representing the largest contributor among those tumor types. He described growth across both academic institutions and community oncology practices as balanced. The company also cited a formulary addition at a nationally recognized community oncology network, which it said resulted from coordination among sales, market-access and medical-affairs teams. Chief Strategy Officer Christi Cioffi discussed a testicular-cancer awareness initiative called “Indy’s Nuts,” launched in May at the Indianapolis 500. The campaign included sponsorships involving race car driver Jack Harvey and NFL linebacker Alex Singleton, as well as distribution of more than 100,000 bags of peanuts. According to Cioffi, the effort was designed to encourage testicular self-exams and earlier diagnosis while also educating patients about cisplatin-induced hearing loss, or CIO, and the importance of discussing hearing preservation before treatment. Fennec also used a racing-themed exhibit at the American Society of Clinical Oncology annual meeting, where it said it generated hundreds of healthcare-professional leads. Chief Medical Officer Dr. Pierre Sayad said the company’s medical-science liaison team increased total unique healthcare-professional reach by 63% and unique affiliated-site reach by 72% during the second quarter. Fennec nearly tripled its medical-congress presence across national and regional conferences, he said. Sayad said the company initiated a third investigator-sponsored study with the University of Arizona Cancer Center. The study is evaluating PEDMARK in AYA and adult patients with head-and-neck and testicular cancers receiving cisplatin. Two earlier institutional studies at Tampa General Hospital Cancer Institute and City of Hope are actively enrolling patients, he said. Fennec said an investigator-initiated Phase II/III trial in Japan, known as STS-J01, has been selected for an oral presentation at the SIOP 2026 annual meeting in September. The company said the presentation will include the first public human pharmacokinetic data from the study, which evaluates PEDMARK’s potential to reduce CIO in pediatric and AYA patients with non-metastatic solid tumors. Chief Financial Officer Robert Andrade said operating expenses, defined as research and development plus selling, general and administrative costs excluding stock-based compensation, were approximately $13.6 million in the quarter. That was about $3.6 million higher than a year earlier, primarily reflecting commercial headcount and marketing investments. Net product sales: $17.1 million, up 78% year over year. Non-GAAP adjusted EBITDA: $2.8 million, compared with a $1.2 million loss in the prior-year quarter. Earnings per share: $0.05, compared with a loss of $0.11 per share a year earlier. Cash and cash equivalents: $41.2 million as of June 30, 2026. Andrade said Fennec expects approximately $50 million in total cash operating expenses for 2026, with $20 million to $22 million remaining to be recorded in the second half. While the company expects its cash balance at the end of the third quarter to be lower than at the end of the second quarter due to customer collection cycles, it expects positive cash generation in the fourth quarter and at year-end. Management said cash, cash equivalents and investment securities as of June 30, combined with projected PEDMARK revenue, are expected to fund the business under its current operating plan. The company said it is considering whether it may be in a position to provide revenue guidance for 2027, but it did not commit to doing so. Fennec also said it is evaluating potential business-development opportunities that could complement PEDMARK, though Hackman said the company has not identified a product to add to its commercial portfolio. In Japan, management said it is discussing potential partnerships and intends to pursue a path that could support PEDMARK’s approval while maximizing long-term value across Japan and the broader Asia-Pacific region. Fennec Pharmaceuticals Inc, a biopharmaceutical company, develops product candidates for use in the treatment of cancer in the United States. Its lead product candidate is the Sodium Thiosulfate, which has completed the Phase III clinical trial for the prevention of cisplatin induced hearing loss or ototoxicity in children. The company was formerly known as Adherex Technologies Inc and changed its name to Fennec Pharmaceuticals Inc in September 2014. Fennec Pharmaceuticals Inc was founded in 1996 and is based in Research Triangle Park, North Carolina. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Adherex Technologies Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

RESEARCH TRIANGLE PARK, N.C., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced that the Company will release its second quarter 2026 financial results before the opening of the U.S. financial markets on Tuesday, August 11, 2026. Management will host a conference call and webcast that day to discuss the Company’s financial and business results. Conference Call & Webcast Detail: Date: Tuesday, August 11, 2026Time: 8:30 a.m. Eastern TimeWebcast Link: https://edge.media-server.com/mmc/p/tjdvggzn Participant Link: https://register-conf.media-server.com/register/BI48fe753d5b224919a74621f2198f4c38 To access the live webcast link, log onto www.fennecpharma.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. About Fennec PharmaceuticalsFennec Pharmaceuticals Inc. is a specialty pharmaceutical company committed to the fight against ototoxicity in cancer patients who receive cisplatin-based chemotherapy. Fennec is focused on the commercialization of PEDMARK® to reduce the risk of platinum-induced ototoxicity in cancer patients. PEDMARK received FDA approval in September 2022 and European Commission approval in June 2023 and United Kingdom (U.K.) approval in October 2023 under the brand name PEDMARQSI. In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, will commercialize PEDMARQSI® in Europe, U.K., Australia and New Zealand. PEDMARQSI is now commercially available in multiple countries. PEDMARK has received Orphan Drug Exclusivity in the U.S. and.; PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, which includes eight years plus two years of data and market protection. Further, Fennec has patents providing protection for PEDMARK until 2039 in both the U.S. and internationally. For more information, please visit www.fennecpharma.com and follow on LinkedIn. For further information, please contact: Investors:Robert AndradeChief Financial OfficerFennec Pharmaceuticals Inc.+1 919-246-5299 Corporate and Media:Lindsay Rocco Elixir Health Public Relations+1 [email protected]

Interested in Adherex Technologies Inc.? Here are five stocks we like better. Fennec Pharmaceuticals said PEDMARK is seeing stronger commercial traction, with first-quarter 2026 revenue reaching a record $15.1 million as the company expands its sales force and targets more than 5,400 U.S. treatment sites. The company is focusing on the adolescent and young adult (AYA) market, which management says is about 10 times larger than the pediatric market, and is also promoting home administration through its Fennec HEARS program. Fennec highlighted international expansion and patent protection, including a European partnership with Norgine, plans for a Japan deal, and a U.S. settlement that keeps a generic challenger off the market until 2033. Fennec Pharmaceuticals (NASDAQ:FENC) executives outlined the company’s commercial strategy for PEDMARK, its sodium thiosulfate product used to prevent cisplatin-related hearing loss, during a fireside chat at the H.C. Wainwright 4th Annual BioConnect Investor Conference. Ram Selvaraju, managing director and senior healthcare equity research analyst at H.C. Wainwright, introduced the company and said H.C. Wainwright covers Fennec with a buy rating and a 12-month price target of $13 per share. Fennec Chief Executive Officer Jeff Hackman and Chief Financial Officer Robert Andrade discussed PEDMARK’s market opportunity, recent revenue performance, international plans and patent position. → CAVA Group’s Stock Looks Delicious After Strong Earnings Andrade described PEDMARK as “the first and only approved agent for the prevention of hearing loss” associated with cisplatin, a chemotherapy widely used in solid tumors across pediatric, adolescent, young adult and adult patients. He said cisplatin can be highly effective, with overall effectiveness rates of up to 90% depending on tumor type, but may be associated with hearing loss in up to 75% of patients. Andrade said PEDMARK has been studied for more than 30 years and was evaluated in two Phase 3 trials, including one published in the New England Journal of Medicine. He said the trials statistically showed that hearing loss was reduced, or at least cut in half, in the overall patient population. → SpaceX IPO: Opportunity? Or the Ultimate Hype Trade? Hackman said a key commercial task is increasing awareness among oncologists that cisplatin-related hearing loss can be prevented. “The awareness levels of PEDMARK are low,” he said, adding that the company views that as an opportunity because patients continue to be at risk of losing hearing from cisplatin therapy. Hackman said PEDMARK was initially approved in the pediatric setting, supported by trials conducted with the Children’s Oncology Group at major U.S. centers. He said Fennec’s opportunity expanded after the National Comprehensive Cancer Network issued a Category 2A recommendation for use in adolescents and young adults, or AYA patients, ages 15 to 39. → 2 Software Stocks Turning AI Fears Into Fundamental Gains Hackman said the AYA market is “10x larger than the pediatric market” and is accessed differently because many patients are treated outside academic centers, including in oncology offices and infusion suites. To support broader use, he said Fennec expanded from 10 to 24 sales territories and now targets more than 5,400 sites across the United States. The company has also built Fennec HEARS, a home administration program. Hackman said PEDMARK must be administered six hours after cisplatin, which can make in-home dosing useful after patients receive cisplatin in an infusion setting. Andrade said Fennec nearly doubled quarterly revenue since Hackman joined the company, moving from roughly $7 million in quarterly revenue to $15.1 million in the first quarter of 2026, which executives described as a record quarter. Hackman also said April was a record month, though he noted the newly expanded sales territories had only been active for about a month. Andrade said the $15.1 million quarterly revenue run rate translates to roughly 300 to 400 patients annually, including about 100 AYA patients. He contrasted that with a total AYA market opportunity of more than 20,000 patients and said PEDMARK currently has no competition as the first and only approved product for preventing cisplatin-related hearing loss. Fennec executives said the company is working to build additional real-world evidence through investigator-sponsored trials, or ISTs, that could help support future updates to NCCN recommendations. Andrade said the current NCCN Category 2A recommendation provides enough evidence to get oncologists’ attention, while Category 1 would represent the highest level of support. The company currently has three ISTs enrolling at City of Hope, Tampa General and the University of Arizona. Andrade said these studies are intended to address questions oncologists may have about use in adults, metastatic disease and other real-world settings. Hackman said additional partnerships are expected. Hackman said the company expects interim looks at data rather than waiting for the completion of longer trials. He said Fennec plans to present some data from one of the ISTs in January of next year, assuming patient enrollment and data generation continue as expected. Andrade said Fennec sees a global opportunity for PEDMARK, known in Europe as PEDMARQSI, but intends to pursue international markets through partnerships rather than building its own infrastructure outside the United States. In Europe, Fennec has partnered with Norgine. Andrade said the agreement includes the potential for $200 million in milestones tied to sales or regulatory achievements, along with royalties beginning in the mid-teens percentage range on sales by Norgine. He said the European opportunity is roughly similar to the U.S. opportunity based on population and cisplatin use. Executives also discussed Japan, where Hackman said a 10-site trial showed results similar to the two prior trials conducted elsewhere. Hackman said Fennec believes the study is sufficient to support filing in Japan and said the company is in discussions with potential partners. Andrade said Fennec expects to announce a Japan partnership “in the near future.” Andrade said Fennec recently settled ANDA litigation with generic drugmaker Cipla. Under the settlement, he said Cipla will not enter the market until the end of 2033, giving Fennec a “nice runway” for PEDMARK in the United States. He added that Fennec has 10 years of market exclusivity in Europe through a pediatric-use marketing authorization and global patents extending to 2039, including in Japan. Looking ahead, Hackman said Fennec is evaluating ways to expand its product offerings by adding complementary products that fit with PEDMARK and the company’s existing customer base. He cited Fennec’s reimbursement, home health, supportive care and medical expertise as capabilities that could be applied to additional products as the company grows. Fennec Pharmaceuticals Inc, a biopharmaceutical company, develops product candidates for use in the treatment of cancer in the United States. Its lead product candidate is the Sodium Thiosulfate, which has completed the Phase III clinical trial for the prevention of cisplatin induced hearing loss or ototoxicity in children. The company was formerly known as Adherex Technologies Inc and changed its name to Fennec Pharmaceuticals Inc in September 2014. Fennec Pharmaceuticals Inc was founded in 1996 and is based in Research Triangle Park, North Carolina. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Adherex Technologies’ PEDMARK Push Targets Larger AYA Market After Record Quarter" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

This article first appeared on GuruFocus. Net Product Sales: $15.1 million for Q1 2026, a 73% increase year-over-year from $8.8 million in Q1 2025. Operating Expenses (OpEx): Approximately $14 million for the quarter, with a $6 million year-over-year increase, primarily in SG&A. Cash and Cash Equivalents: $40.1 million as of March 31, 2026, with a $3.3 million increase during the quarter. Operating Cash Flow: $2.3 million for the quarter. Cash OpEx Expectation for 2026: Approximately $50 million, with over 60% in the first half of the year. Positive Cash Flow: Achieved in Q1 2026, with expectations for cash growth in the second half of the year. Warning! GuruFocus has detected 5 Warning Signs with FENC. Is FENC fairly valued? Test your thesis with our free DCF calculator. Release Date: May 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Fennec Pharmaceuticals Inc (NASDAQ:FENC) reported a 73% year-over-year increase in net product sales for the first quarter of 2026, reaching $15.1 million. The company has successfully expanded its commercial team, increasing its reach and frequency in the market, which has contributed to significant growth in new patient enrollments. Fennec HEARS, the company's full-service patient support program, has shown strong performance with a 48% quarter-over-quarter increase in completed infusions. The company is seeing positive early indicators from its Project Ignite initiative, which has expanded its ability to engage healthcare professionals and support adoption. Fennec Pharmaceuticals Inc (NASDAQ:FENC) has announced multiple investigator-initiated studies to evaluate PEDMARK in new patient populations, indicating growing clinical interest and potential for broader adoption. Operating expenses increased by approximately $6 million year-over-year, primarily due to expanded marketing investment and increased commercial headcount. The company does not anticipate receiving the German milestone payment from its partner, Norgine, which could impact expected revenue streams. Despite positive cash flow in the first quarter, Fennec Pharmaceuticals Inc (NASDAQ:FENC) expects the second quarter ending cash to be lower due to collection cycles with customers. The pediatric market is growing at a slower pace compared to the AYA market, which may impact overall growth potential in that segment. There is a natural ramp period for productivity with the newly expanded sales force, which may delay the full realization of benefits from the increased commercial footprint. Q: Can you break down what drove the upside in Q1, whether it was new account additions, deepening utilization of base accounts, or productivity from sales force expansion? A: Jeffrey Hackman, CEO: The upside was driven by Project Ignite, which expanded our reach and frequency, leading to significant uptake. Fennec HEARS also contributed to growth. Terry Evans, CCO, added that new starts in Q2 are balanced between academic and community settings, with growth in both AYA and pediatric markets. Q: Why did you choose the specific tumor types for investigator-initiated studies (ISTs), and what impact could these have on the company? A: Jeffrey Hackman, CEO: ISTs help establish our position and generate data in the AYA and adult populations. Pierre Sayad, CMO, noted that these studies are driven by KOLs and could lead to regulatory conversations and NCCN guideline submissions. They also increase commercial use in participating institutions. Q: What percentage of your volume was driven by new rep hires, and how is their productivity trending in Q2? A: Jeffrey Hackman, CEO: New territories are contributing significantly to growth, with a healthy mix of new and existing prescribers. Terry Evans, CCO, mentioned that the new sales team became effective in March, and early signs of productivity are positive, with a balance between new and existing accounts. Q: What is the typical profile of a high-volume prescriber for PEDMARK, and how many are there in the US? A: Jeffrey Hackman, CEO: We target about 5,400 prescribers, up from 1,000, with uptake in both academic and community settings. Terry Evans, CCO, emphasized the importance of a balanced approach in engaging both academic centers and community practices. Q: What is your internal pipeline for targeting new patient populations treated with platinum-based chemotherapies? A: Jeffrey Hackman, CEO: We target where cisplatin is given, focusing on tumor types like testicular, cervical, and head and neck cancers. Pierre Sayad, CMO, added that there is interest in expanding to bladder and lung cancers, as PEDMARK has potential wherever cisplatin is used. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributes the 73% year-over-year revenue growth to the 'Project Ignite' initiative, which optimized sales reach and frequency through a significant headcount expansion. The commercial strategy has pivoted from a narrow focus to a broader target base of over 5,000 prescribers, up from 1,300, specifically targeting the promotionally sensitive Adolescent and Young Adult (AYA) market. Operational improvements in the 'Fennec HEARS' patient support program have driven conversion rates to a benchmark of 80%, effectively translating prescription demand into completed therapy. Strategic positioning is being reinforced by a growing body of clinical evidence, including three new investigator-initiated studies aimed at expanding PEDMARK's utility in adult head, neck, and testicular cancers. The company is utilizing a 'top-down' adoption approach by partnering with major oncology aggregators and GPOs to integrate PEDMARK into electronic medical record (EMR) order sets. Management highlighted a healthy mix of new and existing prescribers, with established accounts showing deeper utilization and increased vials per account as they become more comfortable with the product. Management expects 2026 to be a defining period, with demand in Q2 already tracking to surpass Q1 based on record enrollment levels observed in April. The company anticipates operating income to grow meaningfully in upcoming quarters due to a predominantly fixed cost base and high operating leverage. Financial guidance assumes approximately $50 million in cash operating expenses for 2026, with over 60% of these costs front-loaded in the first half of the year. International growth is expected to ramp as partner Norgine launches PEDMARQSI in nearly double-digit markets throughout 2026, with potential sales-based milestones by year-end. The company is actively exploring business development opportunities to layer additional commercial assets onto its newly expanded sales infrastructure. Management explicitly stated they no longer anticipate receiving a previously expected milestone payment from the German market. The company expects a temporary dip in cash position for Q2 due to collection cycles, though they project returning to positive cash flow and growth in the second half of 2026. A significant portion of current growth is driven by the AYA population, which is more sensitive to promotional efforts and requires higher dosing (weight-based) than the core pediatric market. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. The full impact of the sales force expansion began in early March following a national meeting, with a natural productivity ramp expected through the second half of 2026. Early indicators are positive, with April demand through the HEARS program alone representing over 50% of the entire first quarter's demand. ISTs are being used to bridge the data gap for AYA and adult physicians who require specific evidence beyond the original pediatric clinical trials. Activating an IST within an institution serves as a commercial catalyst, as the required training for nurses and pharmacists often leads to an uptick in general commercial use. Management is targeting high-volume cisplatin use cases including testicular, cervical, and head and neck cancers as the primary path for expansion. Data from ongoing ISTs will be used to support future NCCN guideline submissions and potential regulatory conversations for metastatic indications.