On May 15, 2018 Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, reported pipeline updates and operating results for the quarter ended March 31, 2018 (Press release, Eleven Biotherapeutics, MAY 15, 2018, View Source [SID1234526642]).

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!

"2018 is set to be a transformational year for the company and, already in the first quarter, we have made important progress in advancing our lead program, Vicinium, for high-grade non-muscle invasive bladder cancer, or NMIBC," said Stephen Hurly, president and chief executive officer of Eleven Biotherapeutics. "Our Phase 3 registration trial, the VISTA Trial, investigating Vicinium for patients with high-grade NMIBC, is progressing well and recently completed enrollment. We look forward to presenting three-month data from the trial in an oral presentation at the American Urological Association Annual Meeting on May 21st, a significant catalyst for the company and our Vicinium program. High-grade NMIBC is a disease for which there is a desperate need for new treatment options, and we look forward to further exploring Vicinium as a potential treatment for these patients."

Pipeline Progress and Updates

Eleven Biotherapeutics will present three-month data from its ongoing Phase 3 VISTA Trial, which is evaluating Vicinium for the treatment of patients with high-grade NMIBC who have been previously treated with bacillus Calmette-Guérin (BCG). The data will be presented during a plenary session on Monday, May 21, 2018 at 11:00 a.m. PDT at the American Urological Association Annual Meeting being held in San Francisco. In March 2018, the company announced enrollment completion in the VISTA Trial.
In April 2018, Eleven Biotherapeutics presented preclinical data from its deBouganin program at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. DeBouganin is a potent deimmunized plant-based toxin designed for systemic use in the treatment of cancer and other indications. The data presented suggest that VB6-845d, a next generation ADC that is composed of an anti-EpCAM antibody fragment fused to deBouganin, mediates tumor cell killing by an immunogenic cell death (ICD) pathway. The potential cross-priming effect initiated by VB6-845d-induced ICD suggests that VB6-845d in combination with immune checkpoint inhibitors may enhance their effectiveness in EpCAM-positive epithelial cancers. Additionally, in collaboration with Crescendo Biologics, the company presented data demonstrating that a potent fusion protein comprised of the company’s deBouganin payload and Crescendo’s Humabody is expressible as a soluble protein in E. coli supernatant and capable of potent killing of cancer cell lines.
First Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents were $19.7 million as of March 31, 2018, compared to $20.3 for the same period in 2017.
Revenue: There was no revenue for the quarter ended March 31, 2018, compared to $0.4 million for the same period in 2017. The decrease was due to a reduction in revenue recognized from the company’s license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche).
R&D Expenses: Research and development expenses were $3.3 million for the quarter ended March 31, 2018, compared to $2.9 million for the same period in 2017. The increase was due primarily to increases in clinical costs.
G&A Expenses: General and administrative expenses were $2.0 million for the quarter ended March 31, 2018, compared to $2.2 million for the same period in 2017. The decrease was due primarily to reductions in legal and professional costs.
Net Loss: Net loss was $4.0 million, or $0.11 per share, for the quarter ended March 31, 2018, compared to net loss of $6.1 million, or $0.25 per share, for the same period in 2017. The decrease was due primarily to the change in the fair value of contingent consideration.
Financial Guidance: Following Eleven Biotherapeutics’ $10.0 million financing in March 2018 and receipt of approximately $4.2 million from the exercise of common stock warrants through mid-May, the company maintains it will have capital to fund its current operating plans into early 2019.
Conference Call Information
The company will host a conference call on May 21, 2018 at 5 p.m. ET to review the data being presented at AUA. To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 4453267. The webcast can be accessed in the Investor Relations section of the company’s website at www.elevenbio.com. The replay of the webcast will be available in the investor section of the company’s website at www.elevenbio.com for 60 days following the call.

About Vicinium
Vicinium, also known as VB4-845, is Eleven Biotherapeutics’ lead product candidate and is a next-generation antibody-drug conjugate (ADC), developed using the company’s proprietary Targeted Protein Therapeutics platform, for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A (ETA). Vicinium is constructed with a stable, genetically engineered peptide linker to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical studies conducted by Eleven Biotherapeutics, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Eleven Biotherapeutics is currently conducting the Phase 3 VISTA Trial, designed to support the registration of Vicinium for the treatment of high-grade NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Three-month data from the ongoing trial are planned for presentation at the 2018 American Urological Association Annual Meeting on May 21, 2018, with 12-month data anticipated in mid-2019. Additionally, Eleven Biotherapeutics believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On May 15, 2018 Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), reported that its President and Chief Executive Officer, John P. Butler, will present at the UBS Global Healthcare Conference on Tuesday, May 22, 2018, at 4:00 p.m. Eastern Time, at the Grand Hyatt New York in New York City (Press release, Akebia, MAY 15, 2018, View Source [SID1234526659]).

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!

A live webcast of the presentation will be available on the company’s website at www.akebia.com. To access the webcast, please log onto the Akebia website at least 15 minutes prior to the webcast to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Akebia’s website following the conference.

On May 15, 2018 Merck reported a decline in sales in the first quarter of 2018 despite organic growth (Press release, Merck KGaA, MAY 15, 2018, View Source [SID1234526792]).

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!

This was due to negative foreign exchange effects. EBITDA pre declined after having benefited from favorable one-time effects in the previous year. Merck confirmed its full-year forecast with respect to organic business performance. However, the company expects slightly higher negative foreign exchange effects.

"When we presented our financial results for 2017, we indicated that 2018 would be a transition year for Merck. The figures for the first quarter confirm this," said Stefan Oschmann, Chairman of the Executive Board and CEO of Merck. "The organic sales growth that we achieved in all regions was more than offset by negative exchange rate effects. For Performance Materials, the market environment in the Liquid Crystals business continues to be difficult. Our focus on moving ahead in all three of our business sectors through innovation remains unchanged."
Net sales of Merck decreased in the first quarter of 2018 by -4.4% to € 3.7 billion (Q1 2017: € 3.9 billion). Organically, Group sales increased by 3.5%, driven by the Healthcare and Life Science business sectors. Merck generated organic growth in all reporting regions. In particular, the U.S. dollar, which was considerably weaker in comparison with the year-earlier period, led to negative exchange rate effects of -7.9%.

EBITDA pre, the company’s most important earnings indicator, declined by -18.2% to € 1.0 billion in the first quarter (Q1 2017: € 1.2 billion). In the year-earlier quarter, favorable one-time effects in the Healthcare business sector led to a higher comparative basis. Group EBIT fell by -31.4% to € 518 million (Q1 2017: € 755 million).

Owing to lower EBIT, net income decreased in the first quarter by -34.8% to € 341 million (Q1 2017: € 523 million). Earnings per share declined from € 1.20 to € 0.78. Earnings per share pre decreased by -21.7% to € 1.41 (Q1 2017: € 1.80).

In the first quarter, Merck lowered its net financial debt by € 170 million compared with December 31, 2017. Consequently, for the first time since the Sigma-Aldrich acquisition, the figure was just under the € 10 billion mark (December 31, 2017: € 10.1 billion). Merck had 53,358 employees worldwide on March 31, 2018.

Healthcare: Bavencio and Mavenclad contribute to organic growth
The Healthcare business sector generated organic sales growth of 1.8% in the first quarter of 2018. The overall development was characterized by negative exchange rate effects of -7.2%. At € 1.6 billion, net sales of Healthcare were thus -5.5% below the level of the year-earlier quarter (Q1 2017: € 1.7 billion).

A driver of organic growth was the performance of the Fertility franchise. Moreover, sales generated by the two new medicines Mavenclad and Bavencio also contributed to organic growth. Sales of Mavenclad, an oral drug for the treatment of multiple sclerosis, were € 13 million. Sales of Bavencio, an immuno-oncology drug, were € 12 million.
In the first quarter, sales of Rebif, which is used to treat relapsing forms of multiple sclerosis, declined organically by -6.7% particularly as a result of the challenging competitive environment in North America and Europe. Taking into account currency headwinds of -9.4%, Rebif sales amounted to € 348 million (Q1 2017: € 415 million). The organic decline of -2.9% in sales of the oncology drug Erbitux as well as exchange rate effects of -5.4% resulted in sales of € 200 million (Q1 2017: € 218 million). Sales of Gonal-f, the leading recombinant hormone for the treatment of infertility, grew organically by 5.7%. Including exchange rate effects of -8.6%, sales amounted to € 166 million (Q1 2017: € 171 million).
At € 430 million, EBITDA pre was -32.0% below the year-earlier quarter (Q1 2017: € 633 million). However, the year-earlier quarter was positively impacted by one-time effects, which created a high comparative basis. This related primarily to income owing to a one-time payment of € 116 million as compensation for future license payments. The foreign exchange environment also weighed on EBITDA pre of Healthcare.
Life Science again generates strong organic sales growth
In the first quarter, Life Science generated strong organic sales growth of 8.8%, which was however almost canceled out by a negative foreign exchange impact of -8.4%. Accordingly, net sales grew slightly by 0.4% over the year-earlier quarter and amounted to € 1.5 billion (Q1 2017: € 1.5 billion). All three business units contributed to organic growth. The largest contribution came from Process Solutions.

The Process Solutions business unit, which markets products and services for the entire pharmaceutical production value chain, generated organic sales growth of 14.1%. Despite an unfavorable foreign exchange effect of -8.8%, net sales totaled € 583 million in the first quarter.
The Research Solutions business unit, which provides products and services to support life science research for pharmaceutical, biotechnological and academic research laboratories, generated moderate organic sales growth of 4.3%. However, owing to negative foreign exchange effects of -8.1%, reported net sales declined to € 509 million.
Applied Solutions generated strong organic sales growth of 7.3% with its broad range of products for clinical and diagnostic testing laboratories as well as the food and beverage industry. Owing to negative foreign exchange effects of -8.2%, net sales declined slightly to € 395 million.
EBITDA pre of Life Science rose by 2.1% to € 455 million (Q1 2017: € 445 million). This was attributable to the good organic sales performance and the synergies from the Sigma-Aldrich acquisition, partly offset however by negative foreign exchange effects.
Semiconducting materials counteract decline in liquid crystals
In the first quarter, net sales of the Performance Materials business sector declined by -12.5% to € 564 million (Q1 2017: € 645 million). This resulted mainly from negative foreign exchange effects of -8.5%. This decrease was amplified by the -4.0% organic decline in sales.

Since April 1, 2018, Performance Materials has been organized into the three business units Display Solutions, Semiconductor Solutions and Surface Solutions. The integrated innovation unit Early Research & Business Development is supporting the business units to identify projects with growth potential and to capture new markets.
The Display Solutions business unit saw an organic decrease in sales in the first quarter, but continued to defend its market leadership position despite stronger competition. The sales decline in Display Solutions stemmed from the decrease in the unusually high market shares in recent years of established liquid crystal technologies. An exception here were OLED materials as well as the energy-saving UB-FFS technology, which each recorded double-digit organic growth. The Semiconductor Solutions business unit, which comprises the business with materials used in integrated circuit production, for instance in the microchip industry, delivered very strong organic growth. The Surface Solutions business unit, which combines the businesses with pigments and functional fillers as well as optoelectronic materials, recorded a slight decline in net sales in the first quarter, which was mainly due to the exceptionally strong year-earlier quarter.
EBITDA pre of Performance Materials fell in the first quarter by -25.7% to € 196 million (Q1 2017: € 263 million). This was due not only to the organic decrease, but also to considerably negative foreign exchange effects.
Merck confirms and specifies outlook
Following the first quarter, Merck continues to expect for the full year 2018 a moderate organic net sales increase of between 3% and 5% over the previous year. Overall, Merck forecasts 2018 Group net sales of € 15.0 billion to € 15.5 billion based on an unchanged portfolio. The planned divestment of the Consumer Health business, which Merck announced on April 19, 2018 and would like to complete in the fourth quarter, is likely to reduce full-year net sales of the Group by between € 0.9 billion and € 1.0 billion. Taking into account the planned Consumer Health divestment, Merck forecasts 2018 Group net sales of € 14.0 billion to € 14.5 billion from continuing operations. The planned divestment does not change the underlying forecasts regarding organic sales growth and the foreign exchange impact.

The company expects that Group EBITDA pre will be in a corridor between € 3.95 billion and € 4.15 billion in 2018. The expected decline in comparison with the previous year primarily reflects negative exchange rate effects on EBITDA pre which the company now sees in a range of -5% to -7% (previously -4% to -6%) versus the previous year owing to the latest exchange rate developments.
In the company’s estimation, the divestment of the Consumer Health business will lower EBITDA pre of the Merck Group by between € 170 million and € 200 million, leading to EBITDA pre from continuing operations in a range of between € 3.75 billion and € 4.0 billion. The planned divestment of the Consumer Health business does not change the company’s assumptions for organic EBITDA pre development and exchange rate effects.

On May 15, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported that it will take part in the UBS 2018 Global Healthcare Conference on Tuesday, May 22, 2018, in New York. Charles Bancroft, executive vice president, Chief Financial Officer and Head of Global Business Operations, will answer questions about the company at 11:30 a.m. ET (Press release, Bristol-Myers Squibb, MAY 15, 2018, View Source [SID1234526613]).

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!

Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

On May 15, 2018 Exicure, Inc., the pioneer in gene regulatory and immunotherapeutic drugs utilizing three-dimensional, spherical nucleic acid (SNA) constructs, reported financial results for the first quarter ended March 31, 2018, and provided an update on corporate progress (Press release, Exicure, MAY 15, 2018, View Source;p=RssLanding&cat=news&id=2349297 [SID1234526643]).

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!

"Exicure continues to drive forward our SNA technology through ongoing clinical development. In the fourth quarter of 2017, we launched a Phase 1 clinical trial of AST-008, our TLR9 agonist developed for immuno-oncology applications. We expect to report results from this trial in the third quarter of 2018," said Dr. David Giljohann, Chief Executive Officer of Exicure. "We are also expanding our efforts in neurology, where pre-clinical results have suggested our spherical nucleic acid platform has advantages over existing technology. We look forward to presenting animal data later this summer."

Corporate Progress

Launched Phase 1 clinical trial of AST-008, a TLR9 agonist for immuno-oncology applications. Received authorization from Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to conduct a Phase 1 clinical trial of AST-008 in the United Kingdom and began dosing healthy subjects during the fourth quarter of 2017. Our current plan anticipates preparing and commencing a Phase 1b/2 clinical trial for AST-008 late this year.
Began dosing patients in the Phase 1 clinical trial of XCUR17 in early April 2018. This trial is designed to test safety and efficacy of the drug. Twenty-five patients will be enrolled and dosed over a period of 26 days. We expect trial data during the third quarter of this year.
Generated pre-clinical data utilizing an SNA designed to stimulate the production of SMN2 mRNA for application in spinal muscular atrophy (SMA). These data suggest that the SNA design may potentially have superior pharmacodynamics properties compared to other nucleic acid therapeutic designs. We are currently collecting in vivo data in SMA mouse models.
Informed by our sponsoring market maker that FINRA has cleared our Form 211. This important step in our path toward trading on the OTCQB has been completed. We are now addressing final administrative items and expect to announce beginning of trading in the near future.
Strengthened management team with the appointment of Matthias Schroff as Chief Operating Officer. Dr. Schroff brings to Exicure a proven track record in clinical development and deep experience in the immuno-oncology, RNAi and gene expression, and TLR9 biology.
Pipeline Updates

AST-008: AST-008 is an SNA consisting of toll-like receptor 9, or TLR9 agonists designed for immuno-oncology applications. The Phase 1 clinical trial of AST-008 evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of AST-008 by subcutaneous administration in healthy volunteers. Our current plan anticipates preparing and commencing a Phase 1b/2 clinical trial for AST-008 late this year. The Company ultimately plans to clinically advance AST-008 in combination with checkpoint inhibitors.

XCUR17: XCUR17 is an antisense SNA that targets the mRNA encoding IL-17RA, a protein that is considered essential in the initiation and maintenance of psoriasis. Our Phase 1 trial of XCUR17 is a microplaque study in patients with mild to moderate psoriasis.

AST-005: AST-005 is an SNA containing TNF antisense oligonucleotides and is intended to be applied in a gel to psoriatic lesions. AST-005 is the subject of our collaboration with Purdue Pharma L.P. Purdue Pharma has notified Exicure it has declined to exercise its option to develop AST-005 at this time, but that it also intends to retain rights relating to the TNF target, and Purdue reserves its right to continue joint development, with Exicure, of new anti-TNF drug candidates and to retain its exclusivity and other rights to AST-005.

First Quarter 2018 Financial Results and Financial Guidance

Cash Position: As of March 31, 2018, Exicure had cash and cash equivalents of $21.1 million compared to $25.8 million as of December 31, 2017.

Research and Development (R&D) Expenses: Research and development expenses were $3.3 million for the quarter ended March 31, 2018, compared to $3.5 million for the quarter ended March 31, 2017. The decrease in research and development expense of $0.2 million was primarily due to a net decrease in costs related to our clinical development programs of $0.6 million, partially offset by higher employee-related expenses of $0.2 million and higher platform and discovery-related expense of $0.2 million.

General and Administrative (G&A) Expenses: General and administrative expenses were $2.0 million for the quarter ended March 31, 2018, compared to $1.4 million for the quarter ended March 31, 2017. The increase in general and administrative expenses of $0.6 million was primarily due to higher legal costs associated with preparation and filing of form S-1 to register the shares of common stock sold last year in connection with our merger and private placement. Also contributing to the increase versus the prior quarter were expenses associated with being a public company and salary increases and new hires.

Net Loss: Net loss was $5.5 million for the quarter ended March 31, 2018, compared to net loss of $2.7 million for the quarter ended March 31, 2017. The $2.9 million increase in net loss is due principally to a $2.4 million decrease in non-cash collaboration revenue in addition to the net increase in operating expenses of $0.4 million discussed above. The quarter ended March 31, 2017 included $2.4 million of collaboration revenue which represented the amortization of deferred revenue associated with the upfront cash payment of $10.0 million received in December of 2016 connected with the Purdue collaboration. On January 1, 2018, we adopted ASC 606 and recorded any remaining unamortized deferred revenue under the Purdue collaboration to the beginning balance of accumulated deficit at January 1, 2018.

Cash Runway Guidance: Exicure believes that, based on its current operating plans and estimates of expenses, as of the date of this press release, its existing cash and cash equivalents as of March 31, 2018, will be sufficient to meet its anticipated cash requirements through March 31, 2019.