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Infinity Pharmaceuticals Announces Royalty Monetization of COPIKTRA™ for $30 Million Gross Proceeds

On March 6, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported a royalty monetization with HealthCare Royalty Partners (HCR) for the right to receive certain royalty payments based on worldwide annual net sales of COPIKTRA (duvelisib), payable by Verastem (Press release, Infinity Pharmaceuticals, MAR 6, 2019, View Source [SID1234534015]). Under the agreement, HCR has agreed to pay Infinity a $30 million upfront payment and up to $20 million in potential milestone payments. The transaction is expected to close by March 11, 2019.

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"This non-dilutive financing provides Infinity with immediate and substantial capital to support our expansion of the breadth and depth of IPI-549 development," said Adelene Perkins, Chief Executive Officer of Infinity. "We continue to be focused on creating value for patients and shareholders as we continue to progress the development of IPI-549 into additional combinations, indications, lines of therapy and later-stage trials."

The right to receive royalty payments will revert to Infinity if HCR receives a multiple of its total investment amount and certain reasonably incurred expenses paid by HCR, up to a prespecified cap amount which increases over time. If the cap amount is met, Infinity will continue to receive COPIKTRA royalty revenue until the revenue stream ends and if the cap amount is not met prior to June 30, 2025, the COPIKTRA royalty revenue will not revert to Infinity and will instead be paid to HCR until the revenue stream ends.

In connection with Infinity’s monetization of its interest in the royalty stream, Infinity has granted to HCR Collateral Management, LLC a security interest in all of the Company’s interest in the royalty stream and other specified collateral, including certain patents owned by Infinity underlying duvelisib and other related rights. HCR Collateral Management may exercise its rights with respect to the collateral under specified limited circumstances.

Under Infinity’s license agreement with Intellikine, LLC, a subsidiary of Takeda Pharmaceuticals Company Limited, Infinity and Takeda would share equally in the royalties due from Verastem. In connection with the royalty monetization, Infinity entered into an amendment of its license agreement with Takeda pursuant to which Takeda has instead agreed to receive a

portion of the total investment amount and Infinity will continue to pay Takeda a percentage of the royalties that would have been payable to Infinity but for the consummation of the transaction. If the right to receive royalty payments from Verastem reverts to Infinity, Infinity will thereafter go back to the original terms of its license agreement.

Verastem will continue to pay directly to Infinity royalties that Infinity is obligated to pay to Purdue Pharmaceutical Products L.P. and Mundipharma International Corporation Limited and Infinity will retain in full its obligations to make the royalty payments to those entities pursuant to its separate agreements with those entities.

For a further description of the foregoing transactions, please refer to Infinity’s Current Report on Form 8-K which was filed with the Securities and Exchange Commission on March 6, 2019.

Morgan Stanley & Co. LLC acted as sole structuring agent on the monetization.

About COPIKTRA (duvelisib) Royalties

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Infinity licensed worldwide development and commercialization rights to COPIKTRA to Verastem, Inc. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.

About Healthcare Royalty Partners HealthCare Royalty Partners ("HCR") is a private investment firm that purchases royalties and uses debt-like structures to invest in commercial or near-commercial stage life science assets. HCR has $4.4 billion in cumulative capital commitments with offices in Stamford (CT), San Francisco, Boston and London. For more information, visit www.healthcareroyalty.com.

Merrimack Reports Fourth Quarter and Full Year 2018 Financial Results

On March 6, 2019 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK), a clinical-stage oncology company focused on biomarker-defined cancers, reported its fourth quarter and full year 2018 financial results for the period ended December 31, 2018 (Press release, Merrimack, MAR 6, 2019, View Source [SID1234534018]).

"Last quarter, we engaged external advisors and initiated a process to explore Merrimack’s strategic alternatives. This is an active process that we are working expeditiously to bring to conclusion, with a range of potential outcomes under consideration. We are also committed to preserving the value of the potential milestones that Merrimack remains eligible to receive from Ipsen," said Richard Peters, M.D., Ph.D., President and Chief Executive Officer. "In light of this ongoing process, we are also prudently advancing our pipeline and are pleased to report today an update from our ongoing Phase 1 study of MM-310 and that six posters have been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, five of which highlight our prioritized preclinical programs, MM-401 and MM-201."

Program Update:

MM-310:

In November 2018, Merrimack amended its Phase 1 study of MM-310 in patients with solid tumors to extend the dosing interval of MM-310 from every three weeks to every four weeks. To date, three patients have been enrolled in the 360 mg every four weeks dose cohort under the amended protocol, which matches the highest dose level reached during the prior version of the protocol at every three weeks.

As of March 4, 2019, all three patients in the 360 mg every four weeks dose cohort continue to be treated in the study: one patient has completed 98 days of treatment and received four cycles of MM-310, reaching stable disease as a best response to date; the second patient has completed 56 days of treatment and received two cycles of MM-310; and the third patient received the first dose 21 days prior. Importantly, there have been no instances of grade 3 peripheral neuropathy reported in this cohort.

If all three patients in the 360 mg every four weeks dose cohort successfully complete the observation period for dose-limiting toxicities, which is expected to occur in mid-March, Merrimack would plan to begin enrolling the next dose-escalation cohort at 420 mg of MM-310 every four weeks.

Preclinical Programs:

In November 2018, in connection with its corporate restructuring and exploration of strategic alternatives, Merrimack narrowed the scope of its preclinical efforts to its two most promising preclinical programs: MM-401, an agonistic antibody targeting a novel immuno-oncology target, TNFR2; and MM-201, a highly stabilized agonist-Fc fusion protein targeting death receptors 4 and 5.

Six posters highlighting Merrimack’s preclinical work have been accepted to the AACR (Free AACR Whitepaper) Annual Meeting, to be held March 29 – April 3, 2019 in Atlanta, Georgia, of which three posters will feature MM-401 and two will feature MM-201, as outlined below:

A novel human TNFR2 antibody (MM-401) modulates T cell responses in anti-cancer immunity

Sunday, March 31, 2019; 1:00 PM-5:00 PM

Exhibit Hall B, Poster Section 23, Poster Board #19

Abstract #555

MM-401: Mechanism of action of a novel agonist TNFR2 antibody that induces co-stimulation of T cells and promotes robust anti-tumor immunity

Tuesday, April 2, 2019; 8:00 AM-12:00 PM

Exhibit Hall B, Poster Section 25, Poster Board #20

Abstract #3270

MM-401, a novel anti-TNFR2 antibody that induces T cell co-stimulation, robust anti-tumor activity and immune memory

Wednesday, April 3, 2019; 8:00 AM-12:00 PM

Exhibit Hall B, Poster Section 15, Poster Board #4

Abstract #4846

Development of a second-generation TRAIL agonist and predictive biomarker profile for colorectal cancer

Sunday, March 31, 2019; 1:00 PM-5:00 PM

Exhibit Hall B, Poster Section 32, Poster Board #4

Abstract #700

Engineering and preclinical activity of MM-201, a best-in-class TRAIL receptor agonist

Monday, April 1, 2019; 1:00 PM-5:00 PM

Exhibit Hall B, Poster Section 32, Poster Board #1

Abstract #2491

Targeting DNA-damage response pathway with a novel nano-liposomal ATR inhibitor in solid tumors

Sunday, March 31, 2019; 1:00 PM-5:00 PM

Exhibit Hall B, Poster Section 1, Poster Board #8

Fourth Quarter and Full Year 2018 Financial Results

In October 2018, Merrimack received $5 million of the $10 million milestone from Servier (formerly Shire) for the first patient dosed in a pivotal clinical trial of ONIVYDE in an indication other than pancreatic cancer. Merrimack received $5 million triggered by the commencement of a multi-part study that Ipsen and Servier are conducting in small cell lung cancer (SCLC). The remaining $5 million would be paid if and when a decision is made by Ipsen and Servier to progress to the second randomized part of the study focused on efficacy.

In November 2018, Merrimack initiated a corporate restructuring intended to maximize value and extend its cash runway into the second half of 2022, preserving the ability to capture the potential remaining milestones from Ipsen, the net amount of which Merrimack plans to pass on to its stockholders. This restructuring has been completed. Merrimack has made significant progress towards the close out of its SHERLOC and SHERBOC studies. Merrimack anticipates these close out efforts to continue into the first half of 2019.

The following summarizes Merrimack’s financial results for the three months and year ended December 31, 2018:

Research and development expenses for the three months ended December 31, 2018 were $10.2 million, compared to $12.4 million for the three months ended December 31, 2017. Research and development expenses for the year ended December 31, 2018 were $50.0 million, compared to $67.3 million for the year ended December 31, 2017. Research and development spending for the three months and year ended December 31, 2018 included $1.0 million related to the November 2018 restructuring and reflected reduced expenditures over comparable periods in 2017. The decrease was primarily due to phasing and close out of certain clinical development programs;

General and administrative expenses for the three months ended December 31, 2018 were $4.0 million, compared to $4.7 million for the three months ended December 31, 2017. General and administrative expenses for the year ended December 31, 2018 were $15.6 million, compared to $28.5 million for the year ended December 31, 2017. General and administrative spending for the three months and year ended December 31, 2018 included $0.3 million related to the November 2018 restructuring and was less than expenditures over comparable periods in 2017, primarily due to a decrease in corporate expenses related to reduced headcount levels and stock-based compensation;

Net loss attributable to Merrimack’s continuing operations for the three months ended December 31, 2018 was $12.9 million, or $0.97 per share, compared to a net loss attributable to Merrimack’s continuing operations of $11.8 million, or $0.89 per share, for the three months ended December 31, 2017. Net loss for the year ended December 31, 2018 was $60.8 million, or $4.55 per share, compared to a net loss attributable to Merrimack’s continuing operations of $74.8 million, or $5.66 per share, for the year ended December 31, 2017; and

As of December 31, 2018, Merrimack had 13.3 million shares of common stock, $0.01 par value per share, outstanding.

Financial Outlook

Merrimack believes that its cash, cash equivalents and marketable securities of $71.3 million as of December 31, 2018, excluding any potential milestone payments, together with possible restructuring and cost cutting measures that Merrimack could implement in the future, provide Merrimack with the potential to fund its operations into at least the second half of 2022.

Merrimack remains eligible to receive additional milestone payments from Servier and Ipsen, resulting from Merrimack’s asset sale to Ipsen in 2017:

Merrimack is entitled to receive up to an additional $5 million in milestones from Servier, which is excluded from Merrimack’s cash runway guidance until achieved. This milestone is triggered by Ipsen’s and Servier’s decision to progress their ongoing multi-part clinical trial evaluating ONIVYDE in SCLC into the second randomized portion of the study focused on efficacy;

Merrimack is also entitled to receive up to an aggregate of $450 million in regulatory-based milestones from Ipsen, which Merrimack has said it expects to pass through to its stockholders, net of any taxes owed and subject to there being sufficient surplus at that time, consisting of:

$225 million upon approval by the FDA of ONIVYDE for the first-line treatment of metastatic adenocarcinoma of the pancreas, subject to certain conditions;

$150 million upon approval by the FDA of ONIVYDE for the treatment of SCLC after failure of first-line chemotherapy; and

$75 million upon approval by the FDA of ONIVYDE for an additional indication unrelated to those described above.

Lipocine Announces Financial and Operational Results for the Year Ended December 31, 2018

On March 6, 2019 Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, reported financial results for the year ended December 31, 2018 (Press release, Lipocine, MAR 6, 2019, View Source [SID1234534017]).

Fourth Quarter 2019 and Recent Corporate Highlights

·Currently conducting an ABPM clinical study to assess TLANDO’s effect on blood pressure, if any. The study has enrolled 138 subjects and results are currently expected before the end of the first quarter of 2019.
·The Patent Trial and Appeal Board ("PTAB") of the United States Patent and Trademark Office ("PTO") granted Lipocine’s Priority Motion in the interference case with Clarus Therapeutics, and entered adverse judgment against Clarus. The PTAB ruling cancels all claims of the Clarus 8,828,428 patent. Clarus has filed an appeal of the PTAB judgement to the Court of Appeals for the Federal Circuit.
·Successfully completed a definitive phlebotomy study which supports the reliability of TLANDO clinical measurements conducted in the Phase 3 trials.
·Data from clinical trials of LPCN 1144 in potential non-alcoholic fatty liver disease ("NAFLD") patients were presented at the NASH-TAG Conference, January 2019, in Park City, UT.
·Data highlighting the association of hypogonadism and NAFLD and interim liver fat reductions with LPCN 1144 treatment were presented at the Keystone Symposia on Integrated Pathways of Disease in non-alchoholic steatohepatitis ("NASH") and NAFLD, January 2019 in Santa Fe, NM.
·Interim results from an ongoing sixteen-week Liver Fat Imaging study demonstrated meaningful liver fat reduction in patients treated with LPCN 1144. Liver fat changes were assessed using magnetic resonance imaging, proton density fat fraction ("MRI-PDFF") technique, a non-invasive quantitative biomarker of liver fat content.
oTreatment results showed post-treatment absolute and relative mean reductions in liver fat of 7.6% and 38%, respectively, from baseline levels.
oSixteen-week results from the study are currently expected before the end of the first quarter of 2019.
·Received clearance by U.S. Food and Drug Administration ("FDA") for an Investigational New Drug ("IND") application to initiate a Phase 2 clinical study of LPCN 1144 in patients with biopsy confirmed NASH.

Year Ended December 31, 2018 Financial Results

Lipocine reported a net loss of $11.7 million, or ($0.55) per diluted share, for the year ended December 31, 2018, compared with a net loss of $21.0 million, or ($1.05) per diluted share, in the year ended December 31, 2017.

Research and development expenses were $6.5 million for the year ended December 31, 2018, compared with $11.0 million for the year ended December 31, 2017. The decrease in research and development expenses year over year was primarily due to reduced costs associated with TLANDO which include decreased contract research organization expenses, decreased contract manufacturing expenses and decreased outside services and consulting costs. Additionally, there were significant decreases in contract manufacturing expenses associated with LPCN 1107.

General and administrative expenses were $5.3 million for the year ended December 31, 2018, compared with $10.2 million for the year ended December 31, 2017. The decrease in general and administrative expenses year over year was primarily due to decreased personnel costs related to an overall reduction in headcount resulting in lower stock compensation expense, bonus expense, and salary and related benefit costs in 2018. Additionally, expenses for pre-commercialization marketing and sales activities related to TLANDO decreased significantly.

As of December 31, 2018, the Company had unrestricted cash, cash equivalents and marketable securities aggregating $15.3 million, compared to $21.4 million at December 31, 2017.

Supernus to Present at the 2019 Cowen Health Care Conference

On March 6, 2019 Supernus Pharmaceuticals, Inc. (NASADQ: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, reported that the Company’s management will present an overview and Company update as well as host investor meetings at the 39th Annual Cowen Health Care Conference (Press release, Supernus, MAR 6, 2019, View Source [SID1234534016]).

Date: Wednesday, March 13, 2019

Time: 9:20 a.m. ET

Place: The Boston Marriott Copley Place, Boston, Mass.

Investors interested in arranging a meeting with the Company’s management during this conference should contact the conference coordinator.

A live webcast of the presentation can be accessed by visiting ‘Events & Presentations’ in the Investors Relations section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available for 60 days on the Company’s website after the conference.

Zymeworks Reports 2018 Year-End Financial Results

On March 6, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported financial results for the year ended December 31, 2018 (Press release, Zymeworks, MAR 6, 2019, View Source [SID1234534014]).

"Over the past year, we have made significant progress advancing our own pipeline while our partners continued developing their assets using our technology," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "Our lead program, ZW25, continued to generate impressive clinical data and our second product candidate, ZW49, recently began a Phase 1 clinical trial. We also established our seventh and eighth pharmaceutical partnerships while our long-term partner, Eli Lilly, advanced two of their Azymetric bispecifics into the clinic."

Dr. Tehrani continued, "We entered 2019 with $200 million on our balance sheet, which will enable us to aggressively expand our clinical activities, and we look forward to providing updates throughout the year."

2018 Business Highlights and Recent Developments

ZW49 Investigational New Drug Application Accepted; Phase 1 Trial Underway
Zymeworks’ second product candidate, ZW49, a novel biparatopic HER2-targeted antibody drug conjugate (ADC), received clearance for a Phase 1 first-in-human clinical trial, which has begun enrollment in the United States.
Expanded Global Clinical Development for ZW25 and ZW49
Zymeworks expanded the ZW25 clinical trial into South Korea and also entered into a licensing agreement and collaboration with BeiGene to leverage their resources and expertise to accelerate the development of ZW25 and ZW49 in the Asia Pacific region (Zymeworks continues to own all rights in Japan).
Partner’s Programs Progress into the Clinic
Eli Lilly advanced two Azymetric immune-oncology bispecifics into the clinic triggering milestone payments to Zymeworks. Zymeworks currently has eight active collaborations that offer up to US$7.6 billion in potential milestone payments plus royalties.
Financial Results for the Year Ended December 31, 2018

Revenue in 2018 was $53.0 million as compared to $51.8 million in 2017. Revenue for both years was primarily comprised of non-recurring upfront fees, expansion payments and milestone payments from the Company’s licensing and collaboration agreements. Revenue for 2018 included: recognition of $23.5 million out of the $60.0 million upfront fee from BeiGene associated with a new licensing agreement; an $18.0 million upfront fee related to a second licensing agreement with Daiichi Sankyo; a $5.0 million upfront fee related to a new licensing agreement with LEO Pharma; a $4.0 million research program expansion fee from Celgene; a $2.0 million development milestone payment from Eli Lilly, and $0.5 million in research support payments from various collaborators. Revenue for 2017 included a $50.0 million upfront fee from Janssen and a $1.0 million milestone payment from Daiichi Sankyo, as well as $0.8 million in research support payments.

For the year ended December 31, 2018, research and development expenses were $56.7 million as compared to $41.7 million in the prior year. The change was primarily due to an increase in activities related to ZW25 clinical studies and associated manufacturing costs, as well as development activities for ZW49. There were also additional research and development activities, resulting in incremental headcount-related expense and non-cash stock-based compensation expense. Research and development expenses included non-cash stock-based compensation expense of $2.2 million from equity classified equity awards and a $2.0 million expense related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

For the year ended December 31, 2018, general and administrative expenses were $29.5 million as compared to $18.6 million in the prior year. The change was primarily due to an increase in non-cash liability classified equity adjustments and stock-based compensation, as well as other increases in compensation and professional fees associated with year-on-year corporate growth. General and administrative expense included non-cash stock-based compensation expense of $3.7 million from equity classified equity awards and $5.4 million expense related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

The net loss for the year ended December 31, 2018, was $36.6 million as compared to $10.4 million in 2017, primarily due to an increase in research and development expenses associated with our lead therapeutic candidates and other programs, general and administrative expenses, and the accounting impact of an increase of $6.9 million related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

Zymeworks expects research and development expenditures to increase over time due to the ongoing development of product candidates and other clinical, preclinical, and regulatory activities. Additionally, Zymeworks anticipates continuing to receive revenue from its existing and future strategic partnerships, including technology access fees and milestone-based payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

As of December 31, 2018, Zymeworks had $200.2 million in cash and cash equivalents and short-term investments.