Enterprising Investor
9 meses hace
Merrimack Reports Ipsen Announcement of Approval By The US FDA of Onivyde® (Irinotecan Liposome Injection) Plus 5 Fluorouracil/Leucovorin and Oxaliplatin (NALIRIFOX) as a First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) (2/13/24)
FDA Approval Triggers $225 Million Milestone Payment from Ipsen to Merrimack
Merrimack Expects to Hold Special Meeting of Stockholders to Approve Plan of Dissolution in May 2024
Following Approval of Plan of Dissolution, Merrimack Expects to Issue a Liquidating Dividend Currently Estimated to be Between $14.65 and $15.35 per Share in the Late Spring or Early Summer
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) (“Merrimack” or the “Company”) reported that Ipsen, SA (“Ipsen”) issued a press release today announcing the U.S. Food and Drug Administration has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX) as a first-line treatment for people living with metastatic pancreatic ductal adenocarcinoma (mPDAC).
Under the terms of the 2017 Asset Purchase Agreement between Ipsen and Merrimack (the “Ipsen Agreement”), previously approved by Merrimack’s stockholders, this U.S. Food and Drug Administration approval triggers a $225 million milestone payment from Ipsen to Merrimack which is due on or before March 29, 2024.
“Today’s announcement is the culmination of nearly seven years of clinical trials and regulatory approval efforts by Ipsen following its 2017 purchase of the Onivyde technology from Merrimack. The Company has received several payments from the Ipsen Agreement including: a $575 million payment in 2017, a $5.7 Million working capital adjustment payment later that year, and a $5 million milestone payment in 2019” said Gary Crocker, Chairman of Merrimack’s Board of Directors. “The Board of Merrimack plans to hold a Special Meeting of Stockholders to approve a plan for a corporate dissolution and followed by a distribution of the proceeds to our stockholders from this new $225 million milestone payment, plus residual cash, net of corporate taxes and interest charges accruing under IRS installment sale rules, and other expenses.”
Merrimack’s Board of Directors has evaluated the likelihood of receiving additional milestone payments under the Ipsen Agreement and from the 2019 Agreement with Elevation Oncology (the “Elevation Agreement”) and has concluded that it is unlikely that any additional milestone payments from either agreement will become payable. Based on this analysis, Merrimack expects to hold a special meeting of stockholders by May of 2024 to seek approval for the adoption of a Plan of Dissolution including issuance of a liquidating dividend after the special meeting of stockholders. The Plan will include establishment of a liquidating trust for the benefit of stockholders in the unlikely event that Merrimack might receive any future milestone payments from Ipsen or Elevation Technology.
Stockholders subject to taxation in the United States who receive a liquidating distribution generally will recognize a capital gain or loss equal to the amount received for their shares over their adjusted basis in such shares if shares are held in a taxable account. The tax consequences of the plan of dissolution may vary depending upon the particular circumstances of the stockholder. We recommend that each stockholder consult their tax advisor regarding the U.S. federal income tax consequences of the Plan of Dissolution as well as the state, local and non-U.S. tax consequences.
Based on the information currently available, Merrimack management estimates that the aggregate amount of the liquidating dividend payable to stockholders will be in the range of between approximately $14.65 and $15.35 per share. These estimates are based on, among other things, the receipt of the $225M milestone from Ipsen, Merrimack’s current and projected balance of cash, cash equivalents and marketable securities, estimated federal and state taxes payable for 2024, interest payable to the federal government pursuant to Internal Revenue Code Section 453A and state governments pursuant to similar state tax provisions due on the receipt of the Ipsen milestone payment, proceeds from the expected exercise of stock options, and amounts that will need to be retained by the Company to fund close down expenses and the liquidating trust. The estimated liquidating dividend represents Company management’s estimate of the amount to be distributed to stockholders during the liquidation but does not represent the minimum or maximum distribution amount. The total actual amount of distributions, if any, could be higher or lower, or, although highly unlikely, there may not be any liquidating distributions at all. It is possible that any initial distribution could be followed in the future by further distributions if it is determined that any reserved amounts no longer need to be held by the Company. The Company cannot predict with certainty the amount of liquidating distributions to be paid to Merrimack’s stockholders.
About Merrimack
Merrimack Pharmaceuticals, Inc. is a biopharmaceutical company based in Cambridge, Massachusetts that is entitled to receive up to $225 million in contingent milestone payments related to its sale of Onivyde to Ipsen S.A. in April 2017. This milestone payment is payable by Ipsen on or before March 29, 2024 as Ipsen has received FDA approval on February 13, 2024 for the use of Onivyde® plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) as a treatment of first line metastatic pancreatic ductal adenocarcinoma (mPDAC).
Ipsen has not publicly communicated any current clinical trials which could lead to future milestone payments under the Ipsen Agreement. Elevation Oncology previously announced that it has paused activities under the program from which future milestone payments might be issued to Merrimack under the Elevation Agreement. As a result, Merrimack is not currently expecting to receive these additional potential milestone payments. Neither Ipsen nor Elevation Oncology share any non-public information regarding these programs with Merrimack.
Enterprising Investor
1 año hace
Merrimack Reports Second Quarter 2023 Financial Results (8/03/23)
Cambridge, MA, August 3, 2023 /Business Wire/ – Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(“Merrimack” or the “Company”)] today announced its second quarter 2023 financial results for the period ended June 30, 2023.
“We 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® (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” said Gary Crocker, Chairman of Merrimack’s Board of Directors. “We will continue to monitor the progress of this program which, if approved, would entitle Merrimack to a $225 million milestone payment from Ipsen.”
Second Quarter 2023 Financial Results
Merrimack 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.
Interest income in the second quarter ended June 30, 2023, was $178 thousand compared to $8 thousand for the same period in 2022.
General and administrative expenses for the second quarter ended June 30, 2023, were $569 thousand, compared to $486 thousand for the same period in 2022.
As 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.
As of June 30, 2023, Merrimack had 14.3 million shares of common stock outstanding.
Updates on Programs Underlying Potential Milestone Payments
Ipsen
Metastatic Pancreatic Ductal Adenocarcinoma
- In November 2022, Ipsen announced the Phase III NAPOLI 3 trial of Onivyde (irinotecan liposome injection) plus 5-fluorouracil/leucovorin and oxaliplatin (the “NALIRIFOX regimen”) 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.
- In January 2023, Ipsen presented clinical trial results at the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium.
- In June 2023, Ipsen announced that the U.S. Food and Drug Administration (FDA) had accepted its supplemental new drug application (sNDA) Onivyde® (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.
Small Cell Lung Cancer
- In 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.
- To 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.
Elevation Oncology
- In 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.
About Merrimack
Merrimack 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® 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 (“FDA”) of ONIVYDE for certain additional clinical indications. ONIVYDE® 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’s 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.
Invest-in-America
2 años hace
MACK: I feels like old John-The-Baptist!!! Screaming to the World, but nobody listening!!! GEEEEEEZUS J. KRISTOOOOO!!! Bottom line, Peeps: You can pray to GOD for a Pancreatic Cancer CURE; or, see what MACK Company has up-their-sleeves!!
(LIVE vid., above, of MY 'Personal Financial Planner & Stocks Prognosticator'.)
Invest-in-America
2 años hace
MACK: Buckle-up, my MACK Home-Boys, Home-Girls, Road-Dogs, & straight-up GANG-BANGERS!!! If the Doc's tell-ya you gots PANCREATIC CANCER, well, ya just might me takin' MACK Company's nice new DRUGS!!!!
Invest-in-America
2 años hace
MACK: Look out, old 'MACKY' is back!!! "When that Shark bites, with those teeth babe, scarlet rivers begin to spread!!" (Well, I hope the PRICE here don't drop to 'scarlet' colors!!! I HATE when THAT happens!!!)
"Now listen-up, all California SURFERS!! When that SHARK bites, with those TEETH, babe!! You better be headin' to the SHORE like you had an Evenrude 400 Horsepower outboard strapped to your ASS!!!"
lecorb
4 años hace
Merrimack Pharmaceuticals, Inc. (NASDAQ:MACK) was the recipient of some unusual options trading activity on Wednesday. Stock investors purchased 8,239 call options on the company. This is an increase of 5,115% compared to the average daily volume of 158 call options.
In related news, Director Noah G. Levy bought 69,087 shares of the stock in a transaction dated Tuesday, November 24th. The stock was purchased at an average cost of $3.65 per share, with a total value of $252,167.55. The transaction was disclosed in a legal filing with the Securities & Exchange Commission, which is available at the SEC website. 21.60% of the stock is currently owned by insiders.Several institutional investors and hedge funds have recently modified their holdings of MACK. Private Advisor Group LLC purchased a new stake in Merrimack Pharmaceuticals in the second quarter worth about $25,000. LVW Advisors LLC purchased a new stake in Merrimack Pharmaceuticals in the third quarter worth about $80,000. Bronte Capital Management Pty Ltd. purchased a new stake in Merrimack Pharmaceuticals in the third quarter worth about $2,052,000. Nantahala Capital Management LLC lifted its stake in Merrimack Pharmaceuticals by 0.6% in the third quarter. Nantahala Capital Management LLC now owns 751,943 shares of the biopharmaceutical company’s stock worth $3,008,000 after acquiring an additional 4,308 shares during the period. Finally, Western Standard LLC lifted its stake in Merrimack Pharmaceuticals by 3.1% in the second quarter. Western Standard LLC now owns 869,354 shares of the biopharmaceutical company’s stock worth $2,895,000 after acquiring an additional 26,441 shares during the period. 45.83% of the stock is owned by hedge funds and other institutional investors.
Shares of MACK traded up $2.41 during trading hours on Wednesday, reaching $6.49. 77,082,195 shares of the company traded hands, compared to its average volume of 370,655. Merrimack Pharmaceuticals has a 12-month low of $1.49 and a 12-month high of $7.10. The stock’s fifty day moving average price is $3.83 and its 200 day moving average price is $3.66.
https://www.americanbankingnews.com/2020/12/02/merrimack-pharmaceuticals-sees-unusually-high-options-volume-nasdaqmack.html
TFMG
4 años hace
$MACK | #Merrimack #Pharmaceuticals #GoldenCross
Merrimack Pharmaceuticals , Inc. is a clinical stage biopharmaceutical company, which engages in discovering, developing, and commercializing medicines consisting of novel therapeutics paired with diagnostics for the treatment of cancer. Its pipeline includes MM-131, MM-141, and MM-310. The company was founded by Anthony J. Sinskey, Gavin MacBeath, and Ulrik B. Nielsen in 1993 and is headquartered in Cambridge, MA.
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