1stOncology™: Cancer Intelligence Service – Page 15751 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

BIOGEN REPORTS RECORD REVENUES FOR BOTH THE FULL YEAR AND FOURTH QUARTER OF 2017, $12.3 BILLION AND $3.3 BILLION, RESPECTIVELY

On January 25, 2018 Biogen Inc. (Nasdaq: BIIB) reported full year and fourth quarter 2017 financial results, including (Press release, Biogen, JAN 25, 2018, View Source [SID1234523573]):

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!

•
Full year total revenues of $12.3 billion, a 7% increase versus the prior year or a 15% increase excluding hemophilia revenues*.
◦
Full year multiple sclerosis (MS) revenues grew 4% versus prior year to $9.1 billion, which included $159 million in royalties on our estimate of OCREVUS sales.
▪
For the fourth quarter of 2017, MS revenues grew 5% versus prior year to $2.3 billion, which included $77 million in royalties on our estimate of OCREVUS sales.
▪
U.S. MS revenues in the fourth quarter of 2017 benefitted by approximately $40 million from increased inventory in the channel for TECFIDERA, AVONEX, PLEGRIDY, and TYSABRI compared to the third quarter of 2017.
◦
Full year global TECFIDERA revenues were $4.2 billion, an increase of 6% versus prior year.
◦
Full year global TYSABRI revenues were stable at $2.0 billion.
◦
Full year revenue growth was driven by the launch of SPINRAZA, which contributed $884 million in global revenues.
•
Full year GAAP net income and diluted earnings per share (EPS) attributable to Biogen Inc. of $2.5 billion and $11.92, respectively.
◦
GAAP net income and EPS were negatively impacted by $1.2 billion and $5.51, respectively, due to the transition toll tax and re-measurement of our net deferred tax assets related to the U.S. corporate tax reform legislation.
◦
GAAP net income and EPS were negatively impacted by $110 million and $0.52, respectively, related to the payment to Neurimmune to reduce the royalty payments on potential commercial sales of aducanumab, Biogen’s investigational treatment for Alzheimer’s disease.
◦
GAAP net income and EPS were negatively impacted by $84 million and $0.39, respectively, related to the impairment of ZINBRYTA related assets as a result of the Article 20 procedure of ZINBRYTA in the European Union.

•
Full year non-GAAP net income and diluted EPS attributable to Biogen Inc. of $4.6 billion and $21.81, respectively.
◦
Non-GAAP net income and EPS were negatively impacted by $61 million and $0.29, respectively, related to the impairment of ZINBRYTA related assets.
•
Full year GAAP and non-GAAP net income and diluted EPS were reduced by $73 million and $0.34, respectively, for R&D charges associated with business development transactions with Alkermes plc and Ionis Pharmaceuticals Inc. (Ionis) in the fourth quarter of 2017.

* In Q1 2017, Biogen completed the spin-off of its global hemophilia business into a new company, known as Bioverativ. The 15% increase in total revenues excludes all hemophilia revenues from 2016 through January 2017. Hemophilia revenues include ELOCTATE and ALPROLIX product revenues as well as royalty and contract manufacturing revenue related to Sobi.

(In millions, except per share amounts)
Q4 ’17

Q3 ’17

Q4 ’16

Q4 ’17 v. Q3 ’17

Q4 ’17 v. Q4 ’16

FY ’17

FY ’16

FY ’17 v. FY ’16
Total revenues#
$
3,307

$
3,078

$
2,872

15%

$
12,274

$
11,449

GAAP net income^
$
(297
)

$
1,226

$
649

(124%)

(146%)

$
2,539

$
3,703

(31%)
GAAP diluted EPS
$
(1.40
)

$
5.79

$
2.99

(124%)

(147%)

$
11.92

$
16.93

(30%)

Non-GAAP net income^
$
1,116

$
1,337

$
1,093

(17%)

$
4,645

$
4,423

5%
Non-GAAP diluted EPS
$
5.26

$
6.31

$
5.04

(17%)

$
21.81

$
20.22

8%
# Q4 2017 total revenues grew 26% versus Q4 2016 excluding hemophilia. FY 2017 total revenues grew
15% versus FY 2016 excluding hemophilia for 2016 through January 2017.
^ Net income attributable to Biogen Inc.
Note: Percent changes represented as favorable/(unfavorable)

A reconciliation of GAAP to Non-GAAP full year and quarterly financial results can be found in Table 3 at the end of this press release.

"2017 was a year of strong execution at Biogen," said Michel Vounatsos, Biogen’s Chief Executive Officer. "With a renewed focus on our strategic priorities, we delivered record full year revenues, solid earnings, and significant progress in strengthening the foundation for our future with seven additions to our neuroscience pipeline in 2017."

"Our core MS business demonstrated resilience in an increasingly competitive market, and SPINRAZA has had one of the most successful rare disease launches of all time, bringing new hope to patients and their families. We are also proud of our achievements in business development, with 2017 being one of the most productive years in Biogen’s history."

"And over the next 12 to 18 months, we expect several important data readouts across both our core and emerging growth areas as we continue to advance an industry-leading neuroscience portfolio."

Revenue Highlights
(In millions)
Q4 ’17

Q3 ’17

Q4 ’16

Q4 ’17 v. Q3 ’17

Q4 ’17 v. Q4 ’16

FY ’17

FY ’16

FY ’17 v. FY ’16
Multiple Sclerosis:

TECFIDERA
$
1,076

$
1,070

$
1,002

$
4,214

$
3,968

6%
Total Interferon
$
645

$
662

$
688

(3%)

(6%)

$
2,646

$
2,795

(5%)
AVONEX
$
520

$
538

$
564

(3%)

(8%)

$
2,152

$
2,314

(7%)
PLEGRIDY
$
125

$
124

$
125

$
494

$
482

3%
TYSABRI
$
463

$
469

$
474

(1%)

(2%)

$
1,973

$
1,964

0%
FAMPYRATM
$
24

$
24

$
22

10%

$
92

$
85

8%
ZINBRYTA
$
12

$
14

$
6

(18%)

98%

$
53

$
8

NMF

Spinal Muscular Atrophy

SPINRAZA
$
363

$
271

$
5

34%

NMF

$
884

$
5

NMF

Hemophilia*:

ELOCTATE
$
—

$
—

$
149

NMF

(100%)

$
48

$
513

(91%)
ALPROLIX
$
—

$
—

$
93

NMF

(100%)

$
26

$
334

(92%)

Other Product Revenues:

Biosimilars
$
122

$
101

$
53

21%

130%

$
380

$
101

277%
FUMADERMTM
$
9

$
11

(17%)

(22%)

$
40

$
46

(14%)

Total Product Revenues:
$
2,712

$
2,623

$
2,503

$
10,355

$
9,818

OCREVUS Royalties
$
77

$
65

$
—

19%

NMF

$
159

$
—

NMF
RITUXAN/GAZYVA Revenues
$
338

$
342

$
318

(1%)

$
1,400

$
1,315

6%
Other Revenues
$
180

$
49

$
51

267%

252%

$
360

$
316

14%

Total Revenues#
$
3,307

$
3,078

$
2,872

15%

$
12,274

$
11,449

MS Product Revenues + OCREVUS Royalties
$
2,296

$
2,304

$
2,192

(0%)

$
9,137

$
8,820

4%
Note: Numbers may not foot due to rounding; percent changes represented as favorable/(unfavorable)

•
In the fourth quarter of 2017 SPINRAZA revenues comprised $218 million in sales in the U.S. and $144 million in sales outside the U.S. Inventory levels for SPINRAZA in the U.S. were relatively flat versus the third quarter of 2017. Outside the U.S., SPINRAZA revenues were primarily from Germany, Turkey, and Japan.

•
In the fourth quarter of 2017 other revenues were $180 million, benefitting from increased contract manufacturing.

Expense Highlights
(In millions)
Q4 ’17

Q3 ’17

Q4 ’16

Q4 ’17 v. Q3 ’17

Q4 ’17 v. Q4 ’16

FY ’17

FY ’16

FY ’17 v. FY ’16
GAAP cost of sales
$
509

$
370

$
378

(38%)

(35%)

$
1,630

$
1,479

(10%)
Non-GAAP cost of sales
$
509

$
370

$
363

(38%)

(40%)

$
1,630

$
1,426

(14%)

GAAP R&D
$
588

$
446

$
534

(32%)

(10%)

$
2,254

$
1,973

(14%)
Non-GAAP R&D
$
588

$
446

$
531

(32%)

(11%)

$
2,251

$
1,970

(14%)

GAAP SG&A
$
572

$
434

$
496

(32%)

(16%)

$
1,936

$
1,948

1%
Non-GAAP SG&A
$
554

$
434

$
484

(28%)

(15%)

$
1,901

$
1,930

2%
Note: Percent changes represented as favorable & (unfavorable)

•
Cost of sales in the fourth quarter of 2017 increased versus the third quarter of 2017 primarily due to the increase in contract manufacturing and the impairment of ZINBRYTA related assets.

•
R&D expense in the fourth quarter of 2017 included $78 million related to the exclusive global license and collaboration agreement with Alkermes plc to develop and commercialize BIIB098, a monomethyl fumarate (MMF) small drug molecule.

•
R&D expense in the fourth quarter of 2017 included a $25 million milestone to Ionis related to a new collaboration agreement to identify new antisense oligonucleotide (ASO) drug candidates for the treatment of spinal muscular atrophy (SMA).

•
R&D expense in the fourth quarter of 2016 included a $50 million milestone to Eisai Co. Ltd. following the initiation of Phase 3 trials for elenbecestat (E2609), a beta secretase cleaving enzyme (BACE) inhibitor in development for Alzheimer’s disease.

•
SG&A expense in the fourth quarter of 2017 increased versus the prior quarter primarily due to timing of spend as well as certain investments across sales and marketing, worldwide medical, and general and administrative expense.

Other Financial Highlights
•
For 2017 the Company’s effective full year GAAP tax rate was 48%, and the Company’s effective full year non-GAAP tax rate was 25%. For the fourth quarter of 2017 the Company’s effective GAAP tax rate was 112%, and the Company’s effective non-GAAP tax rate was 29%.
◦
In the fourth quarter of 2017 Biogen booked a GAAP tax charge of $1.2 billion related to the U.S. corporate tax reform legislation.
◦
In the fourth quarter of 2017 Biogen booked a GAAP and non-GAAP tax charge of $42 million and $50 million, respectively, related to the impairment of ZINBRYTA related tax assets.

•
Throughout 2017 Biogen repurchased approximately 4.9 million shares of the Company’s common stock for a total value of $1.4 billion.

•
In the fourth quarter of 2017 Biogen repaid its Senior Notes due March 1, 2018 for $558 million.

•
As of December 31, 2017, Biogen had cash, cash equivalents, and marketable securities totaling approximately $6.7 billion, and approximately $5.9 billion in notes payable and other financing arrangements.

•
For 2017 the Company’s full year weighted average diluted shares were 213 million. For the fourth quarter of 2017 the Company’s weighted average diluted shares were 212 million.

2018 Financial Guidance
Biogen also announced its full year 2018 financial guidance. This guidance consists of the following components:

•
Revenue is expected to be approximately $12.7 billion to $13.0 billion.
•
GAAP and non-GAAP R&D expense is expected to be approximately 16% to 17% of total revenue.
◦
This guidance does not include any impact from potential acquisitions or large business development transactions, as both are hard to predict.
•
GAAP and non-GAAP SG&A expense is expected to be approximately 15% to 16% of total revenue.
•
GAAP tax rate is expected to be approximately 23.5% to 24.5%; non-GAAP tax rate is expected to be approximately 22.5% to 23.5%.
•
GAAP diluted EPS is expected to be between $22.20 and $23.20.
•
Non-GAAP diluted EPS is expected to be between $24.20 and $25.20.

Biogen may incur charges, realize gains, or experience other events in 2018 that could cause actual results to vary from this guidance.

Recent Events
•
In 2017, Biogen added seven clinical programs to its neuroscience pipeline including BIIB098 (MMF prodrug) for MS, BIIB092 (anti-tau antibody) for both Alzheimer’s disease and progressive supranuclear palsy, BIIB076 (anti-tau antibody) for Alzheimer’s disease, BIIB080 (tau antisense oligonucleotide) for Alzheimer’s disease, BIIB093 (IV glibenclamide) for large hemispheric infarction, and natalizumab for drug-resistant focal epilepsy.

•
In January 2018, Biogen acquired the exclusive worldwide rights to develop and commercialize Karyopharm Therapeutics Inc.’s Phase 1 ready investigational oral compound KPT-350 for the treatment of certain neurological and neurodegenerative conditions, primarily amyotrophic lateral sclerosis (ALS). KPT-350 is a novel therapeutic candidate that works by inhibiting XPO1, with the goal of reducing inflammation and neurotoxicity, along with increasing neuroprotective responses. Biogen will pay Karyopharm a one-time upfront payment of $10 million and up to an additional $207 million in milestones, plus tiered royalty payments on potential sales of KPT-350.

•
In January 2018, Biogen dosed the first patient in the Phase 2 SPARK study of BIIB054 (anti-alpha-synuclein antibody) in Parkinson’s disease.

•
In January 2018, Biogen joined Regeneron Pharmaceuticals, Inc., Pfizer Inc., AbbVie Inc., AstraZeneca PLC, and Alnylam Pharmaceuticals, Inc. in a collaboration to collect genetic information on 500,000 people in the UK Biobank database, a project that could help accelerate new drug discovery and improve approval success rates. Biogen has committed $10 million toward this effort.

•
In January 2018, the European Medicines Agency’s Article 20 Procedure of ZINBRYTA was concluded as the European Commission adopted restrictions to minimize the risk of serious liver injury with ZINBRYTA, including restriction of its use to adult patients with relapsing forms of MS who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with any other DMT is contraindicated or otherwise unsuitable.

•
In December 2017, Biogen and Eisai Co., Ltd. announced that an Independent Data Monitoring Committee determined that BAN2401, an anti-amyloid beta protofibril antibody, did not meet the criteria for success based on a Bayesian analysis at 12 months as the primary endpoint in an 856-patient Phase II clinical study (Study 201) for early Alzheimer’s disease. Following the predefined study protocol, the blinded study will continue and a comprehensive final analysis will be conducted at 18 months seeking to demonstrate clinically significant results. The results of the final analysis are expected to be obtained during the second half of 2018.

•
In December 2017, Biogen and Ionis entered into a new collaboration agreement to identify new ASO drug candidates for the treatment of SMA. Biogen will have the option to license therapies arising out of this collaboration and will be responsible for their development and commercialization.

•
In November 2017, Biogen and Alkermes plc entered into a global license and collaboration agreement to develop and commercialize BIIB098, an oral MMF small drug molecule in Phase 3 development for the treatment of relapsing forms of MS.

•
In November 2017, Biogen presented new data from the long-term extension of its ongoing Phase 1b study of aducanumab at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting in Boston, MA. This data includes results from patients in the Phase 1b study who were treated with a gradually increased dose of aducanumab for up to 24 months and those who were treated with a fixed dose of 3, 6, or 10 mg/kg aducanumab for up to 36 months. The results are consistent with previously reported analyses from the Phase 1b study and support the design of the ongoing Phase 3 studies of aducanumab for early Alzheimer’s disease.

•
In November 2017, the end of study results from ENDEAR, the Phase 3 study of SPINRAZA for the treatment of SMA, were published in The New England Journal of Medicine.

•
In October 2017, Biogen and Ionis were awarded the prestigious 2017 Prix Galien USA Award for Best Biotechnology Product for SPINRAZA. The Prix Galien USA Award recognizes extraordinary achievement in scientific innovation that improves the state of human health.

Management Updates
•
In December 2017, Jeffrey D. Capello joined Biogen as Executive Vice President and Chief Financial Officer. Mr. Capello brings 26 years of experience in finance. Most recently he was Executive Vice President and Chief Financial Officer of Beacon Health Options Inc. His previous experience includes founding and running his own company, Monomy Advisors, and serving as Chief Financial Officer of Ortho Clinical Diagnostics, Boston Scientific Corporation, and Perkin Elmer. Earlier in his career he was also a partner in the Boston and Amsterdam offices of PwC.

•
In December 2017, Mark Hernon joined Biogen as Senior Vice President, Chief Information Officer. Mr. Hernon brings more than 30 years of experience in IT and strategic leadership. Most recently he was the Global Head of R&D Site Strategy and Operations at Takeda Pharmaceuticals,

where he led the global transformation of Takeda’s R&D footprint. His previous experience with Takeda Pharmaceuticals also included roles as the Regional Chief Information Officer for the Americas, Global Head of R&D, QA and HR Systems, and Vice President of Operations for the Cambridge, MA site.

•
In November 2017, Chirfi Guindo joined Biogen as Executive Vice President and Head of Global Marketing, Market Access, and Customer Innovation. Mr. Guindo brings 27 years of experience in the global pharmaceutical industry and has held several leadership positions at Merck in Canada, the U.S., France, Africa, and the Netherlands. Most recently Mr. Guindo was President & Managing Director of Merck Canada.

Conference Call and Webcast
The Company’s earnings conference call for the fourth quarter will be broadcast via the internet at 8:00 a.m. ET on January 25, 2018, and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least one month.

Note about Future Earnings Releases and Calls
Starting with the first quarter 2018 earnings release, Biogen intends to cease publishing press releases relating to future earnings calls, earnings releases, and investor events via newswire services. The Company will post these materials on the Investors section of Biogen’s website, www.biogen.com, and issue a statement on Twitter (@biogen) when they become available.

Can-Fite Receives from Gebro Holdings $2,200,000 Payment as Part of Distribution Agreement for Piclidenoson in 3 European Countries

On January 25, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported it has received its first payment of approximately $2,200,000 from Gebro Holding GmBH (Press release, Can-Fite BioPharma, JAN 25, 2018, View Source [SID1234523563]). Can-Fite recently announced entering into a distribution agreement with Gebro for the exclusive right to distribute to distribute Can-Fite’s lead drug candidate, Piclidenoson (CF101), for the treatment of rheumatoid arthritis and psoriasis in 3 European countries including Spain, Switzerland and Austria, upon receipt of regulatory approvals. The recently signed Gebro distribution agreement adds to the distribution agreements for Piclidenoson that the company already has in place with Cipher Pharmaceuticals (for the distribution of Piclidenoson in Canada for rheumatoid arthritis and psoriasis) and Kwang Dong Pharmaceutical (for the distribution of Piclidenoson in Korea for rheumatoid arthritis).

Under the terms of the distribution agreement, Gebro is making a total upfront and milestone payment of approximately $2,200,000 to Can-Fite. In addition, the agreement provides that additional payments of up to approximately $7,000,000 will be received by Can-Fite upon the achievement of certain regulatory, launch and sales milestones plus double digit royalty payments on net sales.

Gebro Pharma is a privately-owned leading pharma group founded in Austria in the late 1940s with over 500 employees. Its headquarters are located in Fieberbrunn (Austria), where Gebro is a top local leading player, with commercial operations in Spain and Switzerland. In Spain, Gebro is ranked among the top growing companies within the Pharma sector. The therapeutic focus of Gebro is pain with a strong franchise in rheumatology and in Spain, Gebro is ranked nº1 in rheumatology and pain. Alongside, rheumatology and pain, Gebro has also built a portfolio around dermatology, urology, respiratory, GI, and CV depending on the territory.

"We are pleased to receive this upfront and milestone payment of $2,200,000 from Gebro and look towards future potential milestone payments as we advance Piclidenoson through completion of our current Phase III trials in rheumatoid arthritis and psoriasis," stated Can-Fite CEO Dr. Pnina Fishman. Can-Fite recently initiated patient enrolment for its Phase III ACRobat trial of Piclidenoson for the treatment of rheumatoid arthritis.

The rheumatoid arthritis and psoriasis therapeutic market is dominated by biological drugs that are primarily administered via intravenous injection (IV) and have potential side effects. Rheumatoid arthritis and psoriasis are huge unmet need markets, where rheumatoid arthritis is estimated to reach $35B in 2020 and psoriasis is forecast to reach $9B in 2018.

Sorrento Therapeutics CAR-T Manufacturing Capacity Expanded With Opening of East Coast GMP Site in Addition to Primary West Coast Facility

On January 24, 2018 Sorrento Therapeutics, Inc. (NASDAQ:SRNE) ("Sorrento"), reported the expansion of its Good Manufacturing Practices (GMP) CAR-T manufacturing capacity, with an exclusive agreement to operate the "Cellular Immunotherapy and Gene Therapy Facility" at Roger Williams Medical Center (Providence, RI) under Sorrento management (Press release, Sorrento Therapeutics, DEC 24, 2018, View Source [SID1234532248]).

Sorrento estimates that the combination of its East and West Coast manufacturing capacity will allow the company to process CAR-T treatments for over 300 patients a year without the use of a third-party contract manufacturer. Sorrento believes that the current capacity should be sufficient to meet its lead candidate CD38 CAR-T multiple myeloma development needs through and up to FDA approval, and support other upcoming CAR-T development programs.

This latest facility addition brings the total GMP manufacturing sites of Sorrento and its subsidiaries to 5 separate facilities: Judicial Facilities (San Diego, CA) for CAR-T therapies and antibody production, Providence Facilities (RI) for CAR-T therapies, Camino Santa Fe Facilities (San Diego, CA) for oncolytic virus production, Suzhou Facilities (China) for antibody-drug conjugate (linker toxin synthesis and bio conjugation) production and Bioserv Corporation (San Diego, CA) for small molecule and biologics fill and finish, medical devices and high potency compound fill and finish (expected completion later in the year).

"We decided a long time ago that internal manufacturing capability would be a strategic asset for Sorrento," stated Henry Ji, Chairman and CEO. He also noted, "Many biotech companies learned the hard way the risks of entering into a new therapeutic area without internal manufacturing capabilities and having to compete with other companies for limited numbers of third party manufacturers. With all the recent activity in the CAR-T space we are extremely pleased to be in control of our own GMP manufacturing and not have to rely on outside parties for our supply needs for our current and future development work."

As Sorrento moves towards non-viral CAR manufacturing, it also expects both the Judicial and Providence Facilities to be able to increase their capacity throughput and handle multiple CAR-T development programs in parallel.

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, Novartis, 2017, JAN 24, 2018, View Source [SID1234523540])

SELLAS Life Sciences Group to Present Complete Phase 2 Correlative Results for its Lead Cancer Immunotherapy Candidate, galinpepimut-S (GPS), in Treatment of Multiple Myeloma: Oral Presentation at the 2018 European Society for Blood and Marrow Transplantation Meeting

On January 24, 2018 SELLAS Life Sciences Group, Inc. (SELLAS; NASDAQ: SLS) reported that an abstract highlighting the detailed description of antigen-specific immune responses and correlation thereof with clinical effects over time has been accepted for oral presentation at the 2018 European Society for Blood and Marrow Transplantation (EBMT) 44th Annual Meeting taking place March 18-21 in Lisbon, Portugal (Press release, Sellas Life Sciences, JAN 24, 2018, View Source [SID1234523569]).

"The abstract to be presented at the EBMT Conference highlights the depth of our clinical program exploring the potential of GPS as an innovative immunotherapeutic for multiple cancer types," said Angelos M. Stergiou, MD, ScD h.c., President and CEO of SELLAS. "There has been great interest in immuno-oncology approaches for the treatment of MM and GPS offers an exciting opportunity by directly immunizing the host against a key immune target in multiple myeloma, namely WT1, particularly in view of strong differentiating attributes of our hetereoclitic immunotherapeutic as well as the other indications we are carefully pursuing."

Multiple myeloma (MM) patients with high-risk cytogenetics at baseline who also remain positive for minimal residual disease post-frontline autologous stem cell transplantation continue to experience poor clinical outcomes, despite maintenance with immunomodulatory drugs, such as lenalidomide. This is a population segment that represents approximately 15-20% of first-line MM patients. In previous reports, such patients immunized with GPS in a Phase 2 study (n=18) experienced a median progression-free survival of 23.6 months and an 18 month overall survival of 88%.

The presentation at the EBMT Conference will entail detailed correlative analyses between clinical benefit, as reflected by the rate of achievement of complete response/very good partial response, per International Myeloma Working Group criteria, and antigen-specific immuno-responses of the complete dataset from this Phase 2 study.

Details for the presentation are as follows:

Title: Clinical Benefit after Galinpepimut-S (GPS), a WT1 Immunotherapeutic, Correlates With Antigen-Specific Immune Responses in High-Risk Multiple Myeloma: Complete Analysis of the Phase 2 GPS Maintenance Study.
Presenter: Guenther Koehne, MD, PhD, Miami Cancer Institute, Baptist Health South Florida
Session: Oral Session 4 – Multiple Myeloma; Room 5B
Abstract Number: A-947-0029-01047
Date/Time: March 19, 2018, 3:50 p.m WET/ 10:50 a.m. EST
Location: Centro de Congressos de Lisboa / Lisbon Congress Centre (LCC), Room 5B
The presentation will be made available on the Presentations section of Sellas’ website at www.sellaslifesciences.com/publications immediately following the presentation.

About galinpepimut-S (GPS)

GPS is a heteroclitic multivalent, multi-peptide cancer immunotherapeutic agent composed of four peptides, addressing over 20 epitopes, and derived from the WT1 protein, which has been ranked by the National Cancer Institute as a top priority among cancer antigens for immunotherapy. Importantly, because the WT1 antigen is over-expressed in many malignancies, and is not found in most normal tissues, GPS has the potential to be a broad immunotherapy, effective across a multitude of diverse cancer types and patient populations.