On November 9, 2016 Immunocore Limited, a world-leading biotechnology company developing novel T cell receptor (TCR) based biological drugs to treat cancer, infectious diseases and autoimmune diseases, reported it will present positive data from its Phase I clinical monotherapy trial in uveal melanoma (UM) of its lead product, IMCgp100, an ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) (Press release, Immunocore, NOV 9, 2016, View Source [SID1234518901]). These data demonstrate clear early evidence of monotherapy activity of IMCgp100 in patients with uveal melanoma and strengthens the data announced at ASCO (Free ASCO Whitepaper) 2016.

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Alexander Shoushtari MD, PhD, Medical Oncologist at Memorial Sloan Kettering Cancer Center, will be giving an oral presentation at the Society for Melanoma Research (SMR) 2016 Congress at the Boston Marriott Copley Place Hotel in Boston, Massachusetts on 9th November, 2016 at 10.40am EST. The title of the presentation is: "A Phase I study of IMCgp100, a soluble HLA-A2 restricted gp100-specific T cell receptor-CD3 therapeutic with solid tumour activity in patients with advanced uveal melanoma".

In the study, 15 patients with UM were treated and are evaluable for efficacy. Preliminary Phase I results suggest activity in UM. Durable objective responses were observed and the disease control rate was 53% at 16 weeks and 40% at 24 weeks. The study’s dosing regimen included an intra-patient escalation to mitigate the risk of cytokine release and IMCgp100 demonstrated a favourable safety profile with manageable T cell mediated toxicity.

The Phase I study in UM will identify the escalated dose that can be administered in the intra-patient escalation regimen. The pivotal Phase II study in UM is on track to start dosing patients during the first quarter of 2017.

Dr Christina Coughlin, Chief Medical Officer at Immunocore, commented: "We continue to be encouraged by the clinical data we are observing with our lead asset, IMCgp100. Data from this trial so far has demonstrated clear early evidence of activity in uveal melanoma, an indication where patients have no treatments that have shown any survival benefit. We look forward to taking this product further forward in its clinical development."

On November 9, 2016 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) reported its third quarter 2016 financial results (Press release, Merrimack, NOV 9, 2016, View Source [SID1234516467]).

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Merrimack will host a live conference call and webcast today, Wednesday, November 9 at 4:30 p.m., Eastern time, to provide an update on Merrimack’s progress as well as a summary of these results.

Investors and the general public are invited to listen to the call by dialing (877) 564-1301 (domestic) or (224) 357-2394 (international) five minutes prior to the start of the call and providing the passcode 89606889. A listen-only webcast of the call can be accessed in the Investors section of Merrimack’s website, investors.merrimack.com, and a replay of the call will be archived there for six weeks following the call.

ONIVYDE (irinotecan liposome injection) Update

ONIVYDE updates include:

Receipt by Shire plc of European Marketing Authorization for ONIVYDE for the treatment of patients with metastatic adenocarcinoma of the pancreas following gemcitabine-based therapy;
Establishment of an initial tolerable dose for ONIVYDE in combination with 5-FU/LV and oxaliplatin in an ongoing study evaluating its use in patients with previously untreated metastatic pancreatic cancer;
Issuance by the Centers for Medicare & Medicaid Services (CMS) of a unique, permanent J-code for ONIVYDE, which will streamline the billing and reimbursement process for healthcare providers. The new J-code, J9205 (Injection, irinotecan liposome, 1mg), will become effective for dates of service beginning January 1, 2017 and supersedes all other temporary codes;
Shipments of ONIVYDE from specialty distributors to individual accounts and facilities, a measure of product demand, grew 18% in the third quarter of 2016 as compared to shipments in the second quarter of 2016; and
Recognition of $16.8 million of gross product revenues, or $14.5 million of net product revenues, from U.S. commercial sales of ONIVYDE for the third quarter of 2016. This is compared to $14.8 million of gross product revenues, or $12.9 million of net product revenues for the second quarter of 2016, which represents an increase in net product revenues of 13% over the prior quarter.
Key Recent Events

Merrimack’s key recent events include:

Acceptance for review of an Abbreviated New Drug Application (ANDA) filed by Actavis LLC for generic doxorubicin hydrochloride (HCl) liposome injection (DOXIL). This is the first product developed by Merrimack under a development, license and supply agreement with Actavis pursuant to which Merrimack is responsible for the development and commercial supply of bulk drug product. If the product is approved, Merrimack is eligible to receive a percentage share of net profits in the mid-twenties on future sales of doxorubicin HCl liposome injection in the United States.
Announcement on October 3, 2016, of a 22% reduction in headcount as part of a major corporate restructuring with the objective of prioritizing its research and development on a focused set of systems biology-derived oncology products and strengthening its financial runway. On this same date, Merrimack also announced the resignation of Robert Mulroy, its former President and Chief Executive Officer.
Initiation, in connection with the corporate restructuring, of a strategic review of the company’s pipeline, including the clinical and financial prioritization of its programs. This review may result in amendments to Merrimack’s ongoing clinical trials and other changes to its programs. The company expects to complete this review by the end of 2016. In the absence of clinical trial amendments, Merrimack believes that the data readouts of trials for its lead product candidates, including potentially MM-302, MM-121 and ONIVYDE in front-line metastatic pancreatic cancer, will likely extend beyond its prior guidance. As part of this strategic review, the company will continue to assess these data timelines and the potential impact of any such clinical trial amendments, and will report these findings by year end.
Third Quarter 2016 Financial Results

The following summarizes Merrimack’s financial results from the quarter ended September 30, 2016:

Product revenues from the commercial sale of ONIVYDE, net of discounts, allowances and reserves, were $14.5 million for the third quarter of 2016, compared to $12.9 million for the second quarter of 2016. This represents an increase of $1.6 million, or 13%, over the prior quarter;
License and collaboration revenues were $12.4 million for the third quarter of 2016, compared to $19.3 million for the second quarter of 2016. This represents a decrease of $6.9 million from the prior quarter. The majority of this decrease was related to a $10.0 million substantive milestone achieved during the second quarter of 2016 offset by increased revenue that was recognized under the proportional performance revenue recognition model;
Aggregate research and development and selling, general and administrative expenses were $50.1 million for the third quarter of 2016, compared to $61.7 million for the second quarter of 2016. This represents a decrease of $11.6 million, or 19%. The majority of this decrease was related to a $10.0 million milestone owed to PharmaEngine in the second quarter of 2016;
Restructuring expenses were $0.8 million for the third quarter of 2016 and were related to Merrimack implementing a 22% reduction in headcount as part of a major corporate restructuring with the objective of prioritizing its research and development on a focused set of systems biology-derived oncology products and strengthening its financing runway;
Interest expense was $6.9 million for the third quarter of 2016, compared to $21.1 million for the second quarter of 2016. This $14.2 million decrease was primarily due to a $14.6 million one-time, non-cash loss related to the conversion of an aggregate principal amount of $64.2 million of Merrimack’s convertible notes in April 2016; and
Net loss attributable to Merrimack for the third quarter of 2016 was $30.1 million, or $0.23 per share, compared to a net loss attributable to Merrimack of $50.8 million, or $0.40 per share, for the second quarter of 2016.
Financial Outlook

In an effort to provide further insight into the expected timing of upcoming research and development and regulatory milestones, Merrimack provides the following schedule:



Milestone Trigger

Cash Inflows
from Shire plc
(in millions)


Cash Outflows to
PharmaEngine, Inc.
(in millions)


Expected Timing

Milestone Accounting Treatment
Sale1 of ONIVYDE in first major European country

$
30.0


$
25.5


Q4 2016

Substantive
Sale1 of ONIVYDE in two additional major
European countries


30.0



3.0


First half of 2017

Substantive
First patient dosed in small cell lung cancer trial


10.0



—


First half of 2017

Non-Substantive
Sale1 of ONIVYDE in first major non-European,
non-Asian country


5.0



—


First half of 2017

Substantive
Sale1 of ONIVYDE in first Asian country


25.0



25.0


Second half of 2017

Substantive
Total expected cash flows from upcoming
milestones

$
100.0


$
53.5


1 Sale means the earlier of first commercial sale or receipt of pricing/reimbursement approval.

In addition to the above milestones, future potential research and development and regulatory milestone obligations from Shire are $427.5 million and are offset by $35.0 million of future potential commitments to PharmaEngine related to these milestones.
With respect to its fiscal 2016 guidance, Merrimack:

Lowers and narrows its previously provided expense guidance range, such that Merrimack now anticipates aggregate research and development and selling, general and administrative expenses for 2016, when calculated in accordance with GAAP, to be in the range of $235.5 million to $245.5 million. Excluding anticipated milestone obligations to PharmaEngine of $35.5 million, this corresponds to a range of $200.0 million to $210.0 million of anticipated aggregate research and development and selling, general and administrative expenses for 2016, which is a non-GAAP financial measure.
With respect to its fiscal 2017 guidance:

Merrimack had previously provided guidance as to the achievement of $46.5 million of net milestones related to ONIVYDE in 2016. Merrimack is revising this guidance to reflect that Merrimack now anticipates that only $4.5 million of these net milestones are expected to be achieved in 2016. Merrimack now anticipates that the achievement of the remaining $42.0 million of net milestones related to ONIVYDE will occur in the first half of 2017. This remaining amount is made up of $32.0 million of net substantive milestones, which are expected to increase net income in 2017, and $10.0 million of net non-substantive milestones, which are expected to increase deferred revenues on Merrimack’s balance sheet, as they are included in the Shire proportional performance revenue recognition model;

Merrimack anticipates that aggregate research and development and selling, general and administrative expenses for 2017, when calculated in accordance with GAAP, will be approximately $193.0 million, which includes the anticipated achievement of $28.0 million of milestone obligations to PharmaEngine. This corresponds to aggregate research and development and selling, general and administrative expenses, excluding anticipated milestone obligations to PharmaEngine, a non-GAAP financial measure, of approximately $165.0 million for 2017; and

Merrimack expects that at its currently forecasted spending rates, its existing financial resources, together with anticipated net product revenues and net royalty payments from sales of ONIVYDE, the net milestone payments and reimbursements it expects to receive under its Shire collaboration and access to its $25.0 million credit facility, will be sufficient to fund its operations into 2018.
A table reconciling guidance for aggregate research and development and selling, general and administrative expenses, excluding anticipated milestone obligations to PharmaEngine, a non-GAAP financial measure, to aggregate research and development and selling, general and administrative expenses calculated in accordance with GAAP is included at the end of this press release.