On May 15, 2018 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended March 31, 2018 (Press release, Cel-Sci, MAY 15, 2018, View Source [SID1234526658]).The Company also reported key clinical and corporate developments achieved during the quarter.

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Clinical and Corporate Developments included:

CEL-SCI’s Phase 3 head and neck cancer study has been fully enrolled since September 2016. All 928 patients are being followed per the protocol. The primary endpoint of the study, a 10% improvement in overall survival of the Multikine treatment regimen plus Standard of Care (SOC) vs. Standard of Care alone, will be determined after a total of 298 deaths have occurred in the two main comparator arms of the study and have been recorded in the study database. All that remains to be done in this pivotal Phase 3 study is to continue to track patient survival until the 298 deaths have occurred and it can be determined if the primary endpoint has been met.
Closing arguments in the arbitration against the former clinical research organization (CRO) for the Phase 3 trial concluded on April 25, 2018. The parties are now awaiting a decision from the arbitrator.
The U.S. Patent and Trademark Office allowed a patent for CEL-SCI’s LEAPS technology for methods of inducing immune responses.
"We expect two significant and material outcomes in the near term. In the very near term we are awaiting a decision from the arbitrator in our case against our former CRO. The read out of the Phase 3 study is expected to take longer than the decision by the arbitrator, however, based on overall survival data available in the scientific literature for the study’s patient population and the fact that the last patient was enrolled in the study over 1.5 years ago, we believe that the end of the Phase 3 trial is approaching as well," said CEL-SCI’s Chief Executive Officer, Geert Kersten. "Separately, we continue to advance our LEAPS technology through preclinical studies in preparation for human clinical studies. The current work with the Rheumatoid Arthritis vaccine is funded by a $1.5 million grant from the National Institutes of Health."

During the six months ended March 31, 2018, CEL-SCI’s cash increased by approximately $0.7 million. Significant components of this increase include net proceeds from the sale of CEL-SCI’s common stock of approximately $7.1 million offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $6.4 million.

CEL-SCI reported an operating loss of ($4,205,745) for the quarter ended March 31, 2018 versus an operating loss of ($7,906,557) for the quarter ended March 31, 2017. The operating loss was ($9,117,175) for the six months ended March 31, 2018 versus an operating loss of ($12,844,565) for the six months ended March 31, 2017.

The research and development expenses decreased by approximately $4.8 million compared to the six months ended March 31, 2017. The majority of CEL-SCI’s research and development expense relates to its on-going Phase 3 clinical trial. Clinical trial costs tend to be higher during the enrollment phase of the study and because the study is fully enrolled, the expenses incurred over the last six months have decreased. The general and administrative expenses increased by approximately $1.3 million compared to the six months ended March 31, 2017. This increase is primarily due to an increase of approximately $1.0 million in equity based compensation related to the Company’s shareholder approved 2014 Incentive Stock Bonus Plan, and a net increase of approximately $0.3 million in other general and administrative expenses primarily for accounting fees and public relations services.

On May 15, 2018 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported its results for the first quarter 2018 (Press release, BerGenBio, MAY 15, 2018, View Source [SID1234526612]). A presentation of the results by the Company’s management will take place today at 10.00 am CET in Oslo – details below.

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Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are pleased with the progress made during Q1 2018. Patient recruitment into our global Phase II clinical proof-of-concept trials with bemcentinib is progressing well and we expect to deliver interim read-outs across all studies during 2018. Presentation of these results will be at major clinical congresses, including the annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in June. Coinciding with ASCO (Free ASCO Whitepaper), we will host a satellite event that will allow us to meet with our stakeholders and provide insights from KOLs and clinical experts on our selective AXL inhibitor bemcentinib as a potential cornerstone of cancer combination therapy. We believe that we will be able to demonstrate the significant potential of bemcentinib in cancer therapy by making tumour cells visible to the immune system and more susceptible to treatment with chemotherapy, targeted therapy and immuno-oncology drugs."

Highlights – First Quarter 2018

Good progress advancing bemcentinib’s proof-of-concept clinical development

First efficacy endpoint met in Phase II trial of bemcentinib/TARCEVA (erlotinib) combination in advanced lung cancer (NSCLC) patients
Recruitment completed in first stage of Phase II trial of bemcentinib in combination with KEYTRUDA in advanced breast cancer (TBNC) patients
Bemcentinib shown to be well tolerated in all patients enrolled across three combination trials with KEYTRUDA – data presented at ASCO (Free ASCO Whitepaper)-SITC 2018
Single agent therapy with bemcentinib led to increased immune activity in relapsed / refractory leukaemia (AML & MDS) patients – data presented at ASCO (Free ASCO Whitepaper)-SITC 2018
Post period

Private placement raising gross NOK 187.5 million from international institutional investors including from the USA, specialising in the biotechnology sector
Recruitment completed in the first stage of Phase II trial of bemcentinib in combination with KEYTRUDA in NSCLC patients
Preclinical data highlighting bemcentinib’s potential to reverse tumour immune suppression and enhance immune checkpoint inhibitor efficacy, presented at AACR (Free AACR Whitepaper) annual meeting
Publications describe the role of AXL signalling in, and potential therapeutic effect of selective AXL inhibition to counteract the progression of aggressive fibrosis in lung and liver diseases

Presentation and Webcast Details

A presentation by BerGenBio’s senior management team will take place at 10.00 am CET at:
Felix Konferansesenter, Bryggetorget 3, 0125 Oslo
The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/ Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and the presentation will be available at www.bergenbio.com in the section: Investors/ Financial Reports from 7:00 am CET the same day.

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]).

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"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]).

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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]).

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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.