On March 15, 2019 Diplomat Specialty Pharmacy reported 4th Quarter and 2018 Year End Financial Results (Press release, Diplomat Speciality Pharmacy, MAR 15, 2019, View Source [SID1234534376]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

4th Quarter Revenue of $1,361 Million, an increase of 18%, Net (Loss) Income Attributable to Diplomat of $(298.0) Million, compared to $6.5 Million, Adjusted EBITDA of $43.5 Million, an increase of 63%
Full Year Revenue of $5,493 Million, an increase of 22%, Net (Loss) Income Attributable to Diplomat of $(302.3) Million, compared to $15.5 Million, Adjusted EBITDA of $167.8 Million, an increase of 65%
FLINT, Mich., March 15, 2019 /PRNewswire/ — Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation’s largest independent provider of specialty pharmacy and infusion services, announced financial results for the quarter and year ended December 31, 2018. All comparisons, unless otherwise noted, are to the quarter or year ended December 31, 2017. The Pharmacy Benefit Management ("PBM") segment comparisons are impacted by the timing of the Company’s acquisitions, which occurred in late 2017. Prior period financials have been recast to include certain direct expenses as part of cost of sales instead of selling, general and administrative ("SG&A") expense for our Specialty segment. This is a reclassification change only and has no impact on overall results.

Diplomat Specialty Pharmacy (PRNewsFoto/Diplomat Pharmacy, Inc.)

Fourth Quarter 2018 Highlights include:

Revenue of $1,361 million, compared to $1,155 million, an increase of 18%
Specialty segment revenue of $1,192 million, compared to $1,143 million
PBM segment revenue of $179 million, compared to $12 million
Specialty segment total prescriptions dispensed of 229,000, compared to 224,000
PBM segment total volume, adjusted to 30-day equivalent, of 1,936,000, compared to 764,000
Gross margin of 6.9% versus 6.3%
Specialty segment gross margin of 5.7% versus 6.0%
PBM segment gross margin of 14.3% versus 32.8%
EPS of $(4.00) per diluted common share versus $0.09 per diluted common share
Adjusted EBITDA of $43.5 million, compared to $26.6 million
Adjusted EBITDA margin of 3.2% versus 2.3%
Net cash provided by operating activities was $1.8 million, compared to $41.6 million
Net Debt; defined as total debt including contingent consideration less cash and equivalents, decreased to $638.2 million, from $646.7 million at September 30, 2018
Full Year 2018 Highlights include:

Revenue of $5,493 million, compared to $4,485 million, an increase of 22%
Specialty segment revenue of $4,791 million, compared to $4,473 million
PBM segment revenue of $729 million, compared to $12 million
Specialty segment total prescriptions dispensed of 918,000, compared to 886,000
PBM segment total volume, adjusted to 30-day equivalent, of 8,171,000, compared to 764,000
Gross margin of 6.8% versus 6.1%
Specialty segment gross margin of 5.9% versus 6.0%
PBM segment gross margin of 13.1% versus 32.8%
EPS of $(4.07) per diluted common share versus $0.23 per diluted common share
Adjusted EBITDA of $167.8 million, compared to $101.8 million
Adjusted EBITDA margin of 3.1% versus 2.3%
Net cash provided by operating activities was $35.0 million, compared to $135.3 million
Brian Griffin, Chairman and CEO of Diplomat, commented "While our 2018 financial results were strong, market conditions in 2019 are significantly more challenging than expected in our specialty and PBM businesses. 2019 is a rebuilding year, and we continue to focus on driving additional volumes to Diplomat by creating partnerships with health plans and hospital systems to meet the demand for better clinical outcomes and management of specialty spend. We are also committed to rebuilding our PBM business."

"The Company’s cost structure is no longer supported by the current business environment and we are accelerating operational efficiency initiatives.

I remain confident that Diplomat is making the right investments and executing the right strategy and operational initiatives to leverage our competitive strengths and position Diplomat for future growth and profitability," said Griffin.

Fourth Quarter Financial Summary:

Revenue for the fourth quarter of 2018 was $1,361 million, compared to $1,155 million in the fourth quarter of 2017, an increase of $206 million or 18%. Our Specialty segment revenue amounted to $1,192 million, compared to $1,143 million in the prior year quarter, while revenue from our PBM segment amounted to $179 million, compared to $12 million in the prior year quarter. The increase in our Specialty segment was driven by manufacturer price increases and an increase in our oncology and infusion volumes, partially offset by reimbursement compression to maintain contractual relationships with certain payers and a volume decrease in certain therapy classes, including immunology and multiple sclerosis. The increase in our PBM segment is due to timing of our PBM acquisitions late in the fourth quarter of 2017 versus a full quarter impact in the fourth quarter of 2018.

Gross profit in the fourth quarter of 2018 was $93.9 million and generated a 6.9% gross margin, compared to $72.6 million gross profit and a 6.3% gross margin in the fourth quarter of 2017. Gross profit from our Specialty segment was $68.2 million, compared to $68.5 million in the prior year quarter, while gross profit from our PBM segment was $25.6 million, compared to $4.1 million in the prior year quarter. The gross margin increase in the quarter was due to the impact of our PBM acquisitions, partially offset by reimbursement compression in our Specialty segment.

SG&A expenses for the fourth quarter of 2018 were $79.9 million, an increase of $10.2 million, compared to $69.7 million in the fourth quarter of 2017. This increase is primarily driven by a $4.6 million increase in employee cost, including employee cost for our acquired entities, and a $0.6 million increase in share-based compensation. Also contributing to the SG&A expense increase was a $5.9 million increase in amortization expense from definite-lived intangible assets, inclusive of capitalized software for internal use, associated with our acquired entities. We also experienced increases in other SG&A expenses; including, rent due to the addition of our Chandler, Arizona facility, Information Technology ("IT") expense due to the implementation of a new operating system, travel, consulting and professional fees, as well as other miscellaneous expenses. These increases were partially offset by a $2.2 million decrease in acquisition related expenses.

Net (loss) income attributable to Diplomat for the fourth quarter of 2018 was $(298.0) million compared to $6.5 million in the fourth quarter of 2017. This decrease was primarily driven by a $262 million non-cash impairment charge related to goodwill and definite-lived intangible assets associated with our PBM segment due to the effects of client losses and a reduced financial forecast, on our annual impairment analysis, as well as a $46 million non-cash goodwill impairment charge related to our Specialty segment due to the effects of a reduced financial forecast, on our annual impairment analysis. Income from operations for the fourth quarter of 2018, excluding the non-cash impairment charges, was $13.9 million, compared to $2.9 million in the fourth quarter of 2017. We experienced a $6.0 million increase in interest expense due to the outstanding debt required to fund our PBM acquisitions in the fourth quarter of 2017. Our income tax benefit decreased $2.4 million due primarily to a $64.5 million increased tax benefit at statutory rates offset by a $9.8 million impact due to the impairment of our non-deductible goodwill relating to our prior stock acquisitions and a $48.7 million valuation allowance made in the fourth quarter of 2018 on deferred tax assets due to a cumulative loss position driven by the impairment charges. Income taxes were also impacted in the prior year by the passage of the Tax Cuts and Job’s act which, after taking into account the provisions of the Tax Cuts and Jobs Act, caused our net deferred tax liabilities to be re-remeasured for a one-time benefit of approximately $7.9 million. Adjusted EBITDA for the fourth quarter of 2018 was $43.5 million compared to $26.6 million in the fourth quarter of 2017, an increase of $16.9 million.

Earnings per share for the fourth quarter of 2018 was $(4.00) per basic/diluted common share, compared to $0.09 per basic/diluted common share for the fourth quarter of 2017.

Full Year 2018 Financial Summary:

Revenue for 2018 was $5,493 million, compared to $4,485 million in 2017, an increase of $1,007 million or 22%. Specialty segment revenue amounted to $4,791 million, compared to $4,473 million in 2017, while revenue from our PBM segment amounted to $729 million compared to $12 million in 2017. The consolidated revenue increase was principally driven by the full year impact of our 2017 acquisitions, including our PBM acquisitions, and the impact of manufacturer price increases in our Specialty segment. These increases were partially offset by reimbursement compression and by a volume decrease in our immunology, hepatitis C, and multiple sclerosis business categories, as well as other lower margin business categories, including human immunodeficiency virus and osteoporosis, compared to the prior year.

Gross profit in 2018 was $376.0 million and generated a 6.8% gross margin, compared to $274.1 million and a 6.1% gross margin in 2017. Gross profit improved $101.9 million, or 37%, compared to the prior year period. Gross profit from our Specialty segment was $280.6 million, compared to $270.1 million in the prior year, while gross profit from our PBM segment was $95.4 million, compared to $4.1 million in the prior year. The gross margin increase was primarily due to the impact of our PBM acquisitions, partially offset by reimbursement compression in our Specialty segment.

SG&A expenses for 2018 were $335.7 million, an increase of $80.1 million, compared to $255.6 million in 2017. Of this increase, $40.4 million related to employee cost, including employee cost for our acquired entities, a $10.9 million increase in share-based compensation, and a $1.7 million increase in severance and related expenses. Also contributing to the SG&A expense increase was a $27.5 million increase in amortization expense from definite-lived intangible assets, inclusive of capitalized software for internal use, associated with our acquired entities. We further experienced increases in other SG&A expenses including consulting and professional fees; rent due to the addition of our Chandler, Arizona facility; IT expense due to the implementation of a new operating system; recruiting primarily related to our CEO search; travel; as well as other miscellaneous expenses.

Net (loss) income attributable to Diplomat for 2018 was $(302.3) million compared to $15.5 million for 2017. This decrease was primarily driven by a $262 million non-cash impairment charge related to goodwill and definite-lived intangible assets associated with our PBM segment due to the effects of client losses and a reduced financial forecast, on our annual impairment analysis, as well as a $46 million non-cash goodwill impairment charge related to our Specialty segment due to the effects of a reduced financial forecast, on our impairment analysis. Our 2018 income from operations excluding the non-cash impairment charges, was $40.4 million, compared to $18.6 million in 2017. We also experienced a $30.9 million increase in interest expense due to a significant increase in outstanding debt to fund our PBM acquisitions, and a $2.1 million decrease in income tax benefit due to the same factors impacting the fourth quarter 2018. Adjusted EBITDA for 2018 was $167.8 million versus $101.8 million for 2017.

Earnings per share for 2018 was $(4.07) per basic/diluted common share, compared to $0.23 per basic/diluted common share for 2017.

Revised 2019 Financial Outlook

For the full-year 2019, we provide financial guidance as follows:

Revenue between $4.7 and $5.0 billion, versus the previous range of $5.6 to $5.8 billion
Specialty segment revenue between $4.4 and $4.6 billion, versus the previous range of $5.1 to $5.3 billion
PBM segment revenue between $0.3 and $0.4 billion, versus the previous range of $0.45 to $0.5 billion
Net (loss) income attributable to Diplomat between $(37) and $(26) million
Adjusted EBITDA between $110 and $116 million, versus the previous communication of "flat to low single digit percent year over year growth"
Diluted EPS between $(0.50) and $(0.34)
Our EPS expectations for 2019 assume approximately 75,300,000 weighted average common shares outstanding on a diluted basis and a tax rate of (21)% and (18)%, for the low- and high-end of the range, respectively, for the full year 2019, each of which could differ materially.

Earnings Conference Call Information

As previously announced, the Company will hold a conference call to discuss its fourth quarter and full year performance this morning, March 15, 2019, at 8:00 a.m. Eastern Time. Shareholders and interested participants may listen to a live broadcast of the conference call by dialing 833-286-5805 (647-689-4450 for international callers) and referencing participant code 2672528 approximately 15 minutes prior to the call. A live webcast of the conference call and associated slide presentation will be available on the investor relations section of the Company’s website for approximately 30 days at ir.diplomat.is.

On March 15, 2019 March 15, 2019 (GLOBE NEWSWIRE) — Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results and recent corporate highlights for the full year ended December 31, 2018 (Press release, Checkpoint Therapeutics, MAR 15, 2019, http://checkpointtx.com/press-releases/checkpoint-therapeutics-reports-full-year-2018-financial-results-and-recent-corporate-highlights/ [SID1234534375]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "During 2018, we continued to advance our lead clinical programs, CK-101, a third-generation epithelial growth factor receptor ("EGFR") tyrosine kinase inhibitor ("TKI"), and CK-301, a fully human anti-PD-L1 antibody, and presented our first interim clinical data for CK-101 in an oral presentation at the World Conference on Lung Cancer. We look forward to presenting our first interim safety and efficacy data from the ongoing CK-301 study in the second quarter as we continue to enroll potential registration-enabling expansion cohorts in endometrial and colorectal cancers, and plan to initiate a registration trial for CK-101 by year-end."

Financial Results:

Cash Position: As of December 31, 2018, Checkpoint’s cash and cash equivalents totaled $22.0 million, compared to $19.2 million at December 31, 2017, an increase of $2.8 million.
R&D Expenses: Research and development expenses for the year ended December 31, 2018 were $33.7 million, compared to $19.1 million for the year ended December 31, 2017, an increase of $14.6 million.
G&A Expenses: General and administrative expenses for the year ended December 31, 2018 were $6.6 million, compared to $5.4 million for the year ended December 31, 2017, an increase of $1.2 million.
Net Loss: Net loss attributable to common stock holders for the year ended December 31, 2018 was $36.4 million, or $1.27 per share, compared to a net loss of $22.7 million, or $1.00 per share, for the year ended December 31, 2017.
2018 and Recent Corporate Highlights:

In March 2018, Checkpoint completed an underwritten public offering that raised net proceeds of $20.8 million.
Also in March 2018, Checkpoint completed the dose escalation portion of the ongoing Phase 1 trial of CK-301, a fully human anti-PD-L1 antibody, in selected recurrent or metastatic cancers, and initiated the first dose expansion cohort, which is evaluating an 800 mg dose of CK-301 administered every two weeks.
In April 2018, preclinical data were presented on Checkpoint’s BET inhibitor, CK-103, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. CK-103 demonstrated combinatorial effects in an in vivo model with anti-PD-1 antibodies, which may support the development of CK-103 as an anti-cancer agent alone and in combination with CK-301.
In September 2018, Checkpoint announced interim safety and efficacy data from its Phase 1/2 clinical trial of CK-101, a third-generation EGFR TKI being evaluated in advanced NSCLC. The data were presented in an oral presentation at the International Association for the Study of Lung Cancer ("IASLC") 19th World Conference on Lung Cancer in Toronto. CK-101 was well tolerated across multiple dose groups and safe. Durable anti-tumor activity was observed, particularly in treatment-naïve EGFR mutation-positive NSCLC patients.
In October 2018, Checkpoint appointed Christian Béchon to its Board of Directors.
In January 2019, Checkpoint announced that the ongoing multi-center clinical trial of anti-PD-L1 antibody CK-301 was expanded to enroll patients in three endometrial and colorectal cohorts intended to support requests for accelerated approval and BLA submissions to the FDA. The ongoing trial is also enrolling cohorts of patients with NSCLC and cutaneous squamous cell carcinoma.
In March 2019, Checkpoint announced two new patent issuances by the U.S. Patent and Trademark Office and the European Patent Office for CK-101. The patents cover CK-101 in the U.S. and Europe through at least August 2034, not including any potential patent term extensions.

On March 15, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported financial results for the quarter ended December 31, 2018. The Company also reviewed recent milestones (Press release, Stemline Therapeutics, MAR 15, 2019, View Source [SID1234534361]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ELZONRIS (tagraxofusp) – US Approval and Commercial Launch

ELZONRIS was FDA-approved on December 21, 2018 for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years and older.

ELZONRIS has been commercially available in the U.S. since the end of January 2019, and patients are currently being treated with ELZONRIS in the commercial setting.

A Marketing Authorization Application (MAA) for ELZONRIS seeking marketing approval in Europe was submitted to, and subsequently validated by, the European Medicines Agency (EMA) in January 2019. The MAA has been granted accelerated assessment and is currently under review.
ELZONRIS – Market Expansion Efforts

ELZONRIS is being evaluated in clinical trials in additional indications, including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

Based on the clinical results observed in CMML and MF thus far, we are evaluating potential registrational pathways in these indications. For CMML, we intend to discuss registration-directed plans with the FDA mid-year.

We are also working towards expansion opportunities within the BPDCN universe, including maintenance therapy after stem cell transplant.

In parallel, we plan to expand our clinical efforts later this year and next into subsets of AML patients enriched for CD123+ expression.

We expect to provide periodic updates on these initiatives throughout this year and next at scientific conferences.
ASH Conference

In December 2018, ELZONRIS data were selected for four presentations at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) conference. Presentations included results of the BPDCN pivotal trial, delivered via oral presentation, and updated clinical trial data in patients with CMML and MF.

Additionally, we had an active clinical, medical affairs and pre-commercial presence at ASH (Free ASH Whitepaper) focused on BPDCN disease awareness.
SL-801

In October 2018, data from the ongoing Phase 1 trial of SL-801 in patients with advanced solid tumors were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress 2018. We expect to provide further updates at upcoming conferences.
SL-701

In November 2018, data from the Phase 2 trial of SL-701 in patients with second-line glioblastoma (GBM) were delivered via oral presentation at the 23rd Annual Meeting of the Society of Neuro-Oncology (SNO). We expect to provide further updates on this program later this year.
SL-901

SL-901 is a novel kinase inhibitor that was evaluated in an abbreviated Phase 1 trial of solid tumor patients in Europe. Neither a dose limiting toxicity nor maximum tolerated dose was identified, and there was one partial response (PR) in a patient with advanced non-small cell lung cancer. We plan to re-initiate a Phase 1 study by early 2020.
SL-1001

In March 2019, we announced the in-licensing of SL-1001, a novel, selective RET kinase inhibitor that demonstrated potent preclinical in vitro and in vivo activity. We expect to begin IND-enabling studies this year, with a Phase 1 clinical trial targeted for 2020.
Robert Francomano, SVP and Global Head of Commercial, commented, "2018 was a transformational year for Stemline as we invested in building out a focused, world class, commercial organization ahead of the FDA approval of ELZONRIS. We are excited to bring this important new treatment to patients, and our highly talented team is in the field, excited, engaged, and poised for success in 2019."

Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented, "We have built a solid foundation for growth in 2019 and beyond, driven by the launch of ELZONRIS in BPDCN. ELZONRIS is the first drug ever approved for BPDCN and brings to patients with BPDCN a new treatment option and hope. In parallel, our team is working diligently with the EMA in an effort to make ELZONRIS potentially available to patients in Europe. We continue to aggressively pursue market expansion efforts with ELZONRIS, while also building out our overall pipeline, with the goal of improving the lives of patients with cancer."

Fourth Quarter 2018 Financial Results Review
Stemline ended the fourth quarter of 2018 with $60.1 million in cash, cash equivalents and investments, as compared to $78.5 million as of September 30, 2018, which reflects cash expenditures of $18.4 million for the quarter. Subsequent to year-end 2018, Stemline completed a follow-on public offering during January 2019 raising $86.1 million in net cash proceeds bringing total cash, cash equivalents and investments to $125.2 million as of March 15, 2019.

For the fourth quarter of 2018, Stemline had a net loss of $26.6 million, or $0.92 per share, compared with a net loss of $21.7 million, or $0.93 per share, for the same period in 2017.

Research and development expenses were $12.1 million for the fourth quarter of 2018, which reflects a decrease of $4.6 million compared with $16.7 million for the fourth quarter of 2017. The higher costs in 2017 were primarily due to manufacturing and regulatory expenses in support of our BLA filing for ELZONRIS.

General and administrative expenses were $14.9 million for the fourth quarter of 2018, which reflects an increase of $9.7 million compared with $5.2 million for the fourth quarter of 2017. The increase in costs were primarily attributable to pre-launch expenses in support of the commercialization of ELZONRIS and compensation costs related to an increase in headcount to support the commercial launch.

On March 15, 2019 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company pioneering the use of DARPin therapeutics* to treat serious diseases, reported its audited Financial Results for 2018 and the company’s 2018 Annual Report (Press release, Molecular Partners, MAR 15, 2019, View Source [SID1234534327]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Audited Financial Results for 2018 and the company’s 2018 Annual Report are available on the investors section of the company’ website.

Financial Calendar
March 19, 2019 – Expected Publication of Invitation to Annual General Meeting
April 16, 2019 – Annual General Meeting
May 9, 2019 – Interim Management Statement Q1 2019
August 27, 2019 – Publication of Half-year Results 2019 (unaudited)
October 31, 2019 – Interim Management Statement Q3 2019
View Source

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics.
The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin molecules for various ophthalmic indications are also in development. The most advanced DARPin therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid tumors and hematological tumors. MP0274, the second-most advanced DARPin drug candidate owned by Molecular Partners, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently in phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.

On March 14, 2019 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported that it has granted a freedom-to-operate (FTO) license to Zelluna Immunotherapy for the development of mutant RAS T cell receptor (mutRAS TCRs) therapies (Press release, Targovax, MAR 14, 2019, View Source [SID1234554018]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Through the development of the TG neoantigen vaccine program, Targovax has established a significant patent portfolio and know-how in therapies targeting mutant RAS cancers. In addition to covering the TG vaccine program, these patents and know-how are also highly relevant in T cell therapy.

Zelluna Immunotherapy has built a portfolio of validated mutRAS TCRs isolated from long-term cancer survivors treated with first generation TG mutRAS vaccines. Targovax has agreed to out-license Targovax patents and know-how to Zelluna to enable the development of Zelluna’s mutRAS TCRs and create a stronger joint position in the mutRAS TCR field. In addition, the companies have signed a letter of intent to establish an R&D collaboration for the discovery and development of additional novel mutRAS TCR products.

Under the license agreement, Zelluna has been granted a global, non-exclusive license to relevant Targovax patents and know-how, for which Targovax will be compensated financially. The potential deal value amounts to NOK 100 million in milestones and annual fees, in addition to royalties on sales and sub-licensing revenues. Zelluna will retain full rights to, and freedom to operate (FTO) for, its portfolio of mutRAS TCRs and will be responsible for the development of these.

Øystein Soug, CEO of Targovax, said: "Our unique TG technology has already demonstrated a clinical benefit by generating immune responses to RAS driver mutations, and we remain committed to developing mutRAS vaccines in the currently underserved mutant RAS cancer indications. Additionally, we are confident that our proprietary technology and know-how has potential application in the parallel field of T cell therapy; itself a rapidly evolving novel class of immunotherapies. The intention of joining forces with Zelluna, will be strengthening the ability to develop a portfolio of mutRAS TCR products to be applied in T cell therapy, which will complement our TG vaccine development and further solidify Targovax’s strong position as the leader in mutRAS targeted immunotherapy".