{"id":775515,"date":"2023-08-04T08:41:08","date_gmt":"2023-08-04T12:41:08","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/merrimack-reports-second-quarter-2023-financial-results\/"},"modified":"2023-08-04T08:41:08","modified_gmt":"2023-08-04T12:41:08","slug":"merrimack-reports-second-quarter-2023-financial-results","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/merrimack-reports-second-quarter-2023-financial-results\/","title":{"rendered":"Merrimack Reports Second Quarter 2023 Financial Results"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwlistdisc { list-style-type: disc }\n.bwuline { text-decoration: underline }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Merrimack Reports Second Quarter 2023 Financial Results<\/b><\/p>\n<p>CAMBRIDGE, Mass.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nMerrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(\u201cMerrimack\u201d or the \u201cCompany\u201d)] today announced its second quarter 2023 financial results for the period ended June 30, 2023.<\/p>\n<p>\n\u201cWe were excited to see the announcement from Ipsen that the U.S. Food and Drug Administration (FDA) had accepted its supplemental new drug application (sNDA) Onivyde\u00ae (irinotecan liposome injection) plus 5 fluorouracil\/leucovorin and oxaliplatin (NALIRIFOX regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) and that the FDA had provided a Prescription Drug User Fee Act goal date of 13 February 2024 for review of the application\u201d said Gary Crocker, Chairman of Merrimack&#8217;s Board of Directors. \u201cWe will continue to monitor the progress of this program which, if approved, would entitle Merrimack to a $225 million milestone payment from Ipsen.\u201d<\/p>\n<p><b>Second Quarter 2023 Financial Results<\/b><\/p>\n<p>\nMerrimack reported a net loss of $391 thousand for the second quarter ended June 30, 2023, or $0.03 per basic and diluted share on a fully diluted basis, compared to a net loss of $478 thousand, or $0.04 per basic and diluted share on a fully diluted basis, for the same period in 2022.<\/p>\n<p>\nInterest income in the second quarter ended June 30, 2023, was $178 thousand compared to $8 thousand for the same period in 2022.<\/p>\n<p>\nGeneral and administrative expenses for the second quarter ended June 30, 2023, were $569 thousand, compared to $486 thousand for the same period in 2022.<\/p>\n<p>\nAs of June 30, 2023, Merrimack had cash, cash equivalents and short term investments of $19.0 million, compared to $19.4 million as of December 31, 2022.<\/p>\n<p>\nAs of June 30, 2023, Merrimack had 14.3 million shares of common stock outstanding.<\/p>\n<p><b>Updates on Programs Underlying Potential Milestone Payments<\/b><\/p>\n<p><b>Ipsen<\/b><\/p>\n<p><span class=\"bwuline\">Metastatic Pancreatic Ductal Adenocarcinoma<\/span><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nIn November 2022, Ipsen announced the Phase III NAPOLI 3 trial of Onivyde (irinotecan liposome injection) plus 5-fluorouracil\/leucovorin and oxaliplatin (the \u201cNALIRIFOX regimen\u201d) met its primary endpoint demonstrating clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated patients with mPDAC and key secondary efficacy outcome of progression-free survival (PFS) also showed significant improvement over the comparator arm. Ipsen also announced that the safety profile of Onivyde in the NAPOLI 3 trial was consistent with those observed in the previous phase I\/II mPDAC study.<\/p>\n<\/li>\n<li>\nIn January 2023, Ipsen presented clinical trial results at the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium.<\/p>\n<\/li>\n<li>\nIn June 2023, Ipsen announced that the U.S. Food and Drug Administration (FDA) had accepted its supplemental new drug application (sNDA) Onivyde\u00ae (irinotecan liposome injection) plus 5 fluorouracil\/leucovorin and oxaliplatin (NALIRIFOX regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) and that the FDA had provided a Prescription Drug User Fee Act goal date of 13 February 2024 for review of the application.<\/p>\n<\/li>\n<\/ul>\n<p><span class=\"bwuline\">Small Cell Lung Cancer<\/span><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nIn August 2022, Ipsen announced that the Phase III RESILIENT trial did not meet its primary endpoint of overall survival compared to topotecan. The trial is evaluating Onivyde versus topotecan in patients with small cell lung cancer, who have progressed on or after platinum-based first-line therapy treatment. In the announcement, Ipsen indicated that detailed results from the RESILIENT trial would be presented at an upcoming medical conference. The analysis concluded that the primary endpoint overall survival was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate in favor of Onivyde was observed. In the August 2022 announcement, Ipsen reported that the clinical study results would be communicated with the regulatory agency. Ipsen indicated that while the results from the analysis of the RESILIENT trial have not demonstrated an overall survival benefit with Onivyde in patients in second-line small cell lung cancer, Ipsen intends to analyze the data further before decisions regarding next steps are made.<\/p>\n<\/li>\n<li>\nTo date, there have been no further announcements by Ipsen regarding these matters and it remains unclear as to whether Ipsen will continue to seek approval for the use of Onivyde in the small cell lung cancer application. If Ipsen elects not to proceed with seeking regulatory approval, or if regulatory approval is not obtained, Merrimack would not be entitled to the $150 million milestone payment tied to FDA approval of Onivyde for treatment of small cell lung cancer.<\/p>\n<\/li>\n<\/ul>\n<p><b>Elevation Oncology<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nIn January 2023, Elevation announced it is pausing further investment in the clinical development of seribantumab and intends to pursue further development only in collaboration with a partner. If Elevation elects not to proceed with seeking regulatory approval, or if regulatory approval is not obtained, Merrimack would not be entitled to the $54.5 million in additional potential development, regulatory approval and commercial-based milestone payments.<\/p>\n<\/li>\n<\/ul>\n<p><b>About Merrimack<\/b><\/p>\n<p>\nMerrimack Pharmaceuticals, Inc. is a biopharmaceutical company based in Cambridge, Massachusetts that is entitled to receive up to $450.0 million in contingent milestone payments related to its sale of ONIVYDE<sup>\u00ae<\/sup> to Ipsen S.A. in April 2017. These milestone payments would be payable by Ipsen upon approval by the U.S. Food and Drug Administration (\u201cFDA\u201d) of ONIVYDE for certain additional clinical indications. ONIVYDE\u00ae is already approved by the FDA in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. This existing approval is unrelated to any future potential milestone payments. Merrimack\u2019s agreement with Ipsen does not require Ipsen to provide Merrimack with any information on the progress of ONIVYDE clinical trials that is not publicly available. Merrimack is also entitled to receive up to $54.5 million in contingent milestone payments related to its sale of anti-HER3 programs to Elevation Oncology (formerly 14ner Oncology, Inc.) in July 2019.<\/p>\n<p><b>Forward Looking Statements<\/b><\/p>\n<p>\nTo the extent that statements contained in this press release are not descriptions of historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include any statements about Merrimack\u2019s strategy, future operations, future financial position, future revenues and future expectations and plans and prospects for Merrimack, and any other statements containing the words \u201canticipate,\u201d \u201cbelieve,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201ctarget,\u201d \u201cpotential,\u201d \u201cwill,\u201d \u201cwould,\u201d \u201ccould,\u201d \u201cshould,\u201d \u201ccontinue\u201d and similar expressions. In this press release, Merrimack\u2019s forward-looking statements include, among others, Merrimack\u2019s rights to receive payments related to certain milestone events or whether such milestones will be achieved, if at all, the sufficiency of Merrimack\u2019s cash resources and Merrimack\u2019s strategic plan, including any potential distribution of additional cash. Such forward-looking statements involve substantial risks and uncertainties that could cause Merrimack\u2019s future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others: Positive information about pre-clinical and early stage clinical trial results does not ensure that later stage or larger scale clinical trials will be successful. For example, Onivyde\u00ae may not demonstrate promising therapeutic effect or appropriate safety profiles in current or later stage or larger scale clinical trials as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards or to justify further development. Problems or delays may arise prior to the initiation of planned clinical trials, during clinical trials or in the course of developing, testing or manufacturing that could lead Ipsen and Elevation Oncology and their partners and collaborators to fail to initiate or to discontinue development. Even if later stage clinical trials are successful, unexpected concerns may arise from subsequent analysis of data or from additional data. Obstacles may arise or issues may be identified in connection with review of clinical data with regulatory authorities. Regulatory authorities may disagree with Ipsen and Elevation Oncology\u2019s view of the data or require additional data or information or additional studies. In addition, the planned timing of initiation and completion of clinical trials based upon Onivyde\u00ae and the anti-HER Program are subject to the ability of each of Ipsen and Elevation Oncology, respectively, to enroll patients, enter into agreements with clinical trial sites and investigators, and overcome technical hurdles and other issues related to the conduct of the trials for which each of them is responsible. Additionally, each of Ipsen and Elevation Oncology are subject to the risk that they may not successfully commercialize these development programs. Merrimack is also subject to the risk that it may not have funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements. In addition, press releases and other public statements by Ipsen and Elevation Oncology may contain forward-looking statements. Merrimack undertakes no obligation to update or revise any forward-looking statements. Forward-looking statements should not be relied upon as representing Merrimack\u2019s views as of any date subsequent to the date hereof. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Merrimack\u2019s business in general, see the \u201cRisk Factors\u201d section of Merrimack\u2019s Annual Report on Form 10-K filed with the SEC on March 9, 2023, any subsequent quarterly report on Form 10-Q filed by Merrimack and the other reports Merrimack files with the Securities and Exchange Commission.<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20230803597427r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20230803597427\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20230803597427\/en\/<\/a><\/span><\/p>\n<p>\nTim Surgenor<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:ir@merrimack.com\">ir@merrimack.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> United States North America Massachusetts<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Research FDA Clinical Trials Biotechnology General Health Pharmaceutical Health Science Oncology Other Science<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230803597427\/en\/811066\/3\/MACK_Logo_12.2.19.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Merrimack Reports Second Quarter 2023 Financial Results CAMBRIDGE, Mass.&#8211;(BUSINESS WIRE)&#8211; Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(\u201cMerrimack\u201d or the \u201cCompany\u201d)] today announced its second quarter 2023 financial results for the period ended June 30, 2023. \u201cWe were excited to see the announcement from Ipsen that the U.S. Food and Drug Administration (FDA) had accepted its supplemental new drug application (sNDA) Onivyde\u00ae (irinotecan liposome injection) plus 5 fluorouracil\/leucovorin and oxaliplatin (NALIRIFOX regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) and that the FDA had provided a Prescription Drug User Fee Act goal date of 13 February 2024 for review of the application\u201d said Gary Crocker, Chairman of Merrimack&#8217;s Board of Directors. \u201cWe will continue to monitor the progress &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/merrimack-reports-second-quarter-2023-financial-results\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Merrimack Reports Second Quarter 2023 Financial Results&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-775515","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Merrimack Reports Second Quarter 2023 Financial Results - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/merrimack-reports-second-quarter-2023-financial-results\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Merrimack Reports Second Quarter 2023 Financial Results - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Merrimack Reports Second Quarter 2023 Financial Results CAMBRIDGE, Mass.&#8211;(BUSINESS WIRE)&#8211; Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(\u201cMerrimack\u201d or the \u201cCompany\u201d)] today announced its second quarter 2023 financial results for the period ended June 30, 2023. \u201cWe were excited to see the announcement from Ipsen that the U.S. Food and Drug Administration (FDA) had accepted its supplemental new drug application (sNDA) Onivyde\u00ae (irinotecan liposome injection) plus 5 fluorouracil\/leucovorin and oxaliplatin (NALIRIFOX regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) and that the FDA had provided a Prescription Drug User Fee Act goal date of 13 February 2024 for review of the application\u201d said Gary Crocker, Chairman of Merrimack&#8217;s Board of Directors. \u201cWe will continue to monitor the progress &hellip; Continue reading &quot;Merrimack Reports Second Quarter 2023 Financial Results&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/merrimack-reports-second-quarter-2023-financial-results\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2023-08-04T12:41:08+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20230803597427r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"8 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/merrimack-reports-second-quarter-2023-financial-results\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/merrimack-reports-second-quarter-2023-financial-results\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Merrimack Reports Second Quarter 2023 Financial Results\",\"datePublished\":\"2023-08-04T12:41:08+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/merrimack-reports-second-quarter-2023-financial-results\\\/\"},\"wordCount\":1565,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/merrimack-reports-second-quarter-2023-financial-results\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20230803597427r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/merrimack-reports-second-quarter-2023-financial-results\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/merrimack-reports-second-quarter-2023-financial-results\\\/\",\"name\":\"Merrimack Reports Second Quarter 2023 Financial Results - 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(Nasdaq: MACK) [(\u201cMerrimack\u201d or the \u201cCompany\u201d)] today announced its second quarter 2023 financial results for the period ended June 30, 2023. \u201cWe were excited to see the announcement from Ipsen that the U.S. Food and Drug Administration (FDA) had accepted its supplemental new drug application (sNDA) Onivyde\u00ae (irinotecan liposome injection) plus 5 fluorouracil\/leucovorin and oxaliplatin (NALIRIFOX regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) and that the FDA had provided a Prescription Drug User Fee Act goal date of 13 February 2024 for review of the application\u201d said Gary Crocker, Chairman of Merrimack&#8217;s Board of Directors. \u201cWe will continue to monitor the progress &hellip; Continue reading \"Merrimack Reports Second Quarter 2023 Financial Results\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/merrimack-reports-second-quarter-2023-financial-results\/","og_site_name":"Market Newsdesk","article_published_time":"2023-08-04T12:41:08+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20230803597427r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"8 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/merrimack-reports-second-quarter-2023-financial-results\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/merrimack-reports-second-quarter-2023-financial-results\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Merrimack Reports Second Quarter 2023 Financial Results","datePublished":"2023-08-04T12:41:08+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/merrimack-reports-second-quarter-2023-financial-results\/"},"wordCount":1565,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/merrimack-reports-second-quarter-2023-financial-results\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20230803597427r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/merrimack-reports-second-quarter-2023-financial-results\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/merrimack-reports-second-quarter-2023-financial-results\/","name":"Merrimack Reports Second Quarter 2023 Financial Results - 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