On November 13, 2018 Medigene AG (FSE: MDG1, Frankfurt, Prime Standard, SDAX), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies for the treatment of cancer, reported financial results for the first 9 months of 2018 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, MediGene, NOV 13, 2018, View Source [SID1234531242]). The company further improved its financial guidance for the fiscal year 2018.

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Major events in the first three quarters of 2018:
– Start of a Phase I/II clinical trial with T cell receptor-modified T cell therapy (TCR-T) MDG1011 in blood cancers including Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM)
– Expansion of TCR alliance with bluebird bio from four to six TCR projects
– Raise of EUR 32.3 million in oversubscribed private placement to new and existing investors
– Strengthened patent portfolio with new TCR patents in USA and Europe
– Presented data on the successful production of dendritic cell (DC) vaccines for the current Phase I/II clinical trial
– Collaboration with Structured Immunity on improved T cell receptor development

Update Immunotherapies
– Authority approves simplified criteria for patient recruitment in Phase I/II trial with TCR-therapy MDG1011: The German regulatory authority, the Paul-Ehrlich-Institut (PEI), has approved Medigene’s amendment of the trial inclusion criteria. Initial trial protocol required inclusion of one patient per indication (AML, MDS, MM) in a dose cohort of three patients. The adjusted trial protocol requires at least one patient with MM and at least one patient with either AML or MDS. The adjusted trial protocol enables more flexibility and potentially more rapid enrollment of patients. Moreover, an analytical method for determining PRAME expression has been optimized, which results in an increase in the number of potential patients for the clinical trial.
– Successful manufacturing of the first personalized cell product MDG1011: The first personalized MDG1011 cell product was successfully manufactured with patient-specific T cells in compliance with the clinical trial protocol in the course of the trial. A sufficient number of therapeutic TCR-modified T cells with autologous T cells were generated despite the advanced disease stage of the patient. However, the patient could not be treated with the therapeutic product because he dropped out of the trial beforehand due to rapid progression of the underlying disease.
– Preparations to increase the number of trial centers started: Medigene is undertaking intensive preparations with a number of additional hospitals in order to increase the number of centers to allow for an accelerated patient recruitment.

Prof. Dolores Schendel, CEO of Medigene AG, comments: "We are delighted to show that the manufacturing of our highly innovative product MDG1011 worked well with a patient’s own cells in our first-in-man and first-in-country trial with a TCR-modified T cell therapy. The modified study protocol and the expansion of the study centers will improve the general admission for the treatment of these critically ill patients. Our financials are on track and the guidance reflects our intensive research and development activities in the further development of our immunotherapies."

Nine months’ financial results:
– Total revenue increased by 11% to EUR 8.0 million
– Revenue from the core business of immunotherapies increased by 38% to EUR 4.7 million
– Research and development (R&D) expenses increased as planned by 20% to EUR 13.3 million due to extension of the preclinical and clinical development activities for immunotherapy programs
– EBITDA loss increased as anticipated by 5% to EUR 10.7 million
– Net loss increased by 14 % to EUR 12.2 million due to higher R&D expenses and currency effects
– Cash & cash equivalents and time deposits of EUR 76.3 million as at September 30, 2018
– Further improvement of the financial guidance 2018

Financial guidance 2018:
Medigene further improves the financial guidance for 2018 which was raised in the 6M financial statement:
– The Company continues to expect total revenue of EUR 9.5 – 10.5 million in 2018.
– Due to lower than estimated clinical trial costs in 2018, the company now expects to spend EUR 19 – 21 million for the full year 2018 (previous guidance: EUR 21 – 23 million).
– As a result, Medigene is expecting to make a loss at EBITDA level of EUR 16 – 18 million (previous guidance: EUR 18 – 20 million).
– Excluding the proceeds from the capital increase conducted in May 2018, Medigene forecasts a total cash usage of EUR 12 – 14 million for 2018 (previous guidance: EUR 15 – 17 million)
– This forecast does not include potential future milestone payments or cash flows from existing or future partnerships or transactions, as the occurrence of such events and their timing and amount depend to a large extent on external parties and therefore cannot be reliably predicted by Medigene.
– Based on its current planning, the Company has sufficient financial resources to fund business operations beyond the planning horizon of two years.

Outlook immunotherapies:
T cell receptor-modified T cells (TCR-Ts)
The Company is planning to commence treatment of the first dose cohort in the Phase I/II clinical trial of Medigene’s TCR-T MDG1011 therapy for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM). Phase I focuses on the safety and tolerability of the treatment with MDG1011.
In addition to the MDG1011 clinical trial, Medigene will also work on characterizing new TCR candidates for future Medigene-sponsored clinical trials and collecting preclinical data to prepare applications for further clinical TCR-T trials. In addition, Medigene will continue its successful and expanded collaboration with bluebird bio and expects to make further progress on TCR candidate discovery.

Dendritic cell vaccines (DCs)
Medigene continues its ongoing Phase I/II clinical trial with the DC vaccine to treat acute myeloid leukemia (AML). Data from all patients over a treatment duration of one year is expected in the fourth quarter of 2018. This corresponds to the half-way point of the full treatment period. This interim analysis is planned to be presented at scientific conferences in 2019. The final clinical data from the Phase I/II trial are expected at the conclusion of the two-year treatment for all patients towards the end of 2019.

The full version of the quarterly statement 9M-2018 can be downloaded here: www.medigene.com/investors-media/reports-presentations/

Conference call and webcast: A telephone conference (webcast) in English will be held today at 3:00 pm CET (Munich/Frankfurt) / 9:00 am EST (New York) and transmitted live via webcast. Access and transmission of the synchronized presentation slides and a recording of the presentation is available on the homepage of Medigene at www.medigene.com/investors-media/reports-presentations/webcasts/

On November 13, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the first nine months of 2018 (Press release, Evotec, NOV 13, 2018, View Source;announcements/press-releases/p/evotec-ag-reports-first-nine-month-2018-results-and-corporate-updates-5747 [SID1234531238]).

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SIGNIFICANT UPSWING IN FINANCIAL PERFORMANCE
Group revenues: 57% increase to € 270.0 m (9M 2017: € 171.5 m);
EVT Execute revenues up 53% to € 254.3 m (9M 2017: € 165.8 m);
EVT Innovate revenues up 55% to € 51.3 m (9M 2017: € 33.2 m)
Adjusted Group EBITDA up 77% to € 68.7 m (9M 2017: € 38.9 m);
Adjusted EBITDA for EVT Execute of € 62.1 m (9M 2017: € 41.4 m);
Adjusted EBITDA for EVT Innovate of € 6.6 m (9M 2017: € (2.5) m)
Group R&D expenses increase of 67% to € 20.9 m (9M 2017: € 12.5 m) following acquisition of infectious disease unit Evotec ID (Lyon)
Very strong performance in Q3 2018 due to growth in base business, Aptuit contribution, and significant milestone achievements
Strong liquidity position of € 168.6 m even after 50% (€ 70 m) repayment of acquisition loan

EVT EXECUTE – DELIVERING
Clinical Phase I and Phase II starts and good progress within ongoing alliances (e.g. Bayer endometriosis/chronic cough alliance)
Signing of multiple new and extended drug discovery and development agreements (e.g. CHDI, Novo Nordisk, Ferring (after period-end))
New contracts and increased demand for INDiGO solutions and development services (e.g. Ankar, Astex, Inflazome, Yumanity)
Strong performance across all business and service lines (e.g. high-throughput ADME-tox testing at Cyprotex, an Evotec company)

EVT INNOVATE – "JUST THE BEGINNING…"
Two new strategic long-term partnerships with Celgene in oncology (upfront payment: $ 65 m) and targeted protein degradation (financials undisclosed)
Acquisition of Evotec ID (Lyon) creating largest global footprint in infectious disease capabilities with established project pipeline; upfront payment of € 60 m and R&D cost coverage for the first five years
Important milestone achievements in iPSC-based alliances (diabetes alliance with Sanofi, neurodegeneration alliance with Celgene) and further expansion of iPSC platform
Academic BRIDGE model growing (e.g. selection of funded projects under LAB282, LAB150 and LAB591; initiation of French BRIDGE LAB031 with Sanofi)
Participation in additional financing rounds of Forge Therapeutics, FSHD Unlimited, and Topas Therapeutics

CORPORATE
Conversion into European Company (SE) on track
Change in Management Board as of 01 January 2019: Appointment of Dr Craig Johnstone as new COO; Dr Mario Polywka retiring from Evotec
Evotec share listed in MDAX and STOXX Europe 600

GUIDANCE 2018 CONFIRMED
All elements of the financial guidance confirmed

1. SIGNIFICANT UPSWING IN FINANCIAL PERFORMANCE

Evotec’s Group revenues for the first nine months of 2018 grew to € 270.0 m, a significant increase of 57% compared to the same period of the previous year (9M 2017: € 171.5 m, restated). This increase is due to a strong performance in the base business, the positive Aptuit contribution (Jan-Sep 2018: € 83.6 m) as well as increased milestone achievements in existing alliances. The total revenues from milestones, upfronts and licences for the first nine months of 2018 amounted to € 27.2 m and increased by 29% over the same period of the previous year (9M 2017: € 21.1 m). In the first nine months of 2018, the gross margin was 31.0% (9M 2017: 34.8%), reflecting a new business mix with different margin expectations following the acquisition of Aptuit, higher amortisation of intangible assets and adverse FX effects. Gross margin excluding total amortisation of acquisitions amounted to 34.3%.

Q3 2018 delivered a very strong financial performance. Group revenues increased by 43% to € 96.3 m (Q3 2017: € 67.2 m), following growth in the base business, the Aptuit contribution and strong milestone achievements. The significant milestone achievements are reflected in the gross margin of Q3 2018 of 34.7% (Q3 2017: 33.4%). Q3 2018 gross margin excluding total amortisation amounted to 37.7% (Q3 2017: 34.6%). In Q3 2018, an income from bargain purchase of € 15.4 m (Q3 2017: € 0 m) was recorded for the acquisition of Evotec ID (Lyon) as the purchase price was below the net assets required. This one-time effect in 2018 was not allocated to segments and does not impact the adjusted EBITDA. The purchase price allocation is still preliminary. The adjusted Group EBITDA increased from € 12.7 m in Q3 2017 to € 30.1 m in Q3 2018.

Group R&D expenses for the first nine months of 2018 increased as expected by 67% to € 20.9 m (9M 2017: € 12.5 m) mainly following the cost of new strategic efforts in infectious diseases through the acquisition of Evotec ID (Lyon). The additional ID-related R&D expenses are covered by other operating income in context of the new agreement with Sanofi. Furthermore, R&D expenses in the first nine months of 2018 focused on initiatives in the field of iPSC research, R&D platforms as well as academic BRIDGEs. SG&A expenses for the first nine months of 2018 increased as expected by 39% to € 40.8 m (9M 2017: € 29.3 m) mainly due to the additional expenses of Aptuit and Evotec ID (Lyon), an increased headcount in response to the overall Company growth as well as M&A-related expenses. Q3 2018 SG&A expenses remained on a similar level as in prior quarters following the Aptuit acquisition in August 2017.

In the first nine months of 2018, Evotec recorded impairments of intangible assets of € 4.2 m in total (9M 2017: € 1.2 m), following the full impairments of the EVT770 programme (€ 4.0 m) and of the developed assets within the Panion joint venture (€ 0.2 m). At the same time, correlated earn-out accruals of € 2.3 m were relieved under other operating income, which is a counter-effect to the impairment.

Evotec’s adjusted Group EBITDA in the first nine months of 2018 significantly increased by 77% to € 68.7 m (9M 2017: € 38.9 m). Evotec’s operating result for the first nine months of 2018 amounted to € 59.5 m (9M 2017: € 25.5 m). The net result in the first nine months of 2018 increased to € 52.3 m (9M 2017: € 12.7 m).

Liquidity, which includes cash and cash equivalents (€ 135.1 m) and investments (€ 33.5 m) amounted to € 168.6 m at the end of September 2018 (31 December 2017: € 91.2 m) and remained very strong even after the repayment of 50% (€ 70 m) of the Aptuit acquisition loan in the first nine months of 2018. In the first nine months of 2018, Evotec participated in further financing rounds of Forge Therapeutics, FSHD Unlimited, and Topas Therapeutics.

In the first nine months of 2018, revenues from the EVT Execute segment amounted to € 254.3 m, an increase of 53% compared to the same period of the previous year (9M 2017: € 165.8 m). This increase is attributable to the significant upswing in the base business and the Aptuit contribution for the first nine months of 2018. Included in this amount are € 35.6 m of intersegment revenues (9M 2017: € 27.4 m). The EVT Execute segment recorded a gross margin of 24.6% (9M 2017: 28.7%). The drivers behind this change in gross margin are the same drivers affecting the Group gross margin. In the first nine months of 2018, the EVT Execute segment recorded a significant increase of its adjusted EBITDA of 50% to € 62.1 m against the prior-year period (9M 2017: € 41.4 m).

In the first nine months of 2018, the EVT Innovate segment generated third-party revenues of € 51.3 m (9M 2017: € 33.2 m). This 55% increase in EVT Innovate revenues resulted from signing of new partnerships and milestone achievements in key alliances. The EVT Innovate segment reported a gross margin of 48.8% compared to 46.2% in the prior-year period. R&D expenses for EVT Innovate increased from € 15.3 m in the first nine months of 2017 to € 24.1 m in the first nine months of 2018, the increase mainly resulting from the new efforts in infectious diseases in Lyon. The significant growth of revenues and improved margins of the EVT Innovate segment resulted in a positive adjusted EBITDA of € 6.6 m (9M 2017: € (2.5) m).

2. EVT EXECUTE & EVT INNOVATE
EVT EXECUTE
The EVT Execute segment achieved strong progress in existing alliances and signed and started new and expanded established alliances (e.g. CHDI, Novo Nordisk, Ferring (after period-end)). In the multi-target alliance with Bayer, further promising small molecules for the treatment of endometriosis advanced into Phase I and for the treatment of chronic cough into Phase II. Since the beginning of the collaboration in 2012, six first-in-class/best-in-class pre-clinical candidates have been generated, from which three programmes have progressed into Phase I/Phase II clinical trials.

The Aptuit integration into the Evotec Group is on track. In the first nine months of 2018, Evotec was able to sign various new INDiGO agreements with Ankar, Astex, Carna Biosciences, Inflazome, and Yumanity, among others. The INDiGO offering, an integrated and highly efficient process to IND submission, was part of the strategic rationale behind the Aptuit acquisition and was launched by Evotec in March 2018. In addition, Aptuit’s stand-alone development services and integrated CMC continued to deliver and sign new programmes. The high-throughput ADME-tox testing business of Cyprotex (acquired in December 2016) continued its excellent performance of the previous quarters.

EVT INNOVATE
In the first nine months of 2018, the EVT Innovate segment gained significant momentum through signing new deals and achieving critical milestones, resulting in a very strong performance and excellent scientific progress of the segment.

Two new strategic, long-term partnerships were forged with Celgene in the first nine months of 2018. Evotec’s new partnership with Celgene in oncology (initiated in May 2018; upfront payment of $ 65 m) leverages Evotec’s phenotypic screening capabilities and unique compound libraries as well as associated target deconvolution capabilities. Evotec’s third partnership with Celgene is focused on targeted protein degradation (initiated in September 2018; undisclosed upfront payment) which allows the pursuit of high-value drug targets via a novel mechanism of action, which previously have been ‘undruggable’ targets. In this field, Evotec is leveraging in particular its proprietary Panomics and PanHunter platforms.

Furthermore, effective 01 July 2018, Evotec acquired Sanofi’s infectious disease unit in Lyon, triggering an upfront of € 60 m (€ 42 m in cash plus € 18 m cash of the acquired company). This acquisition provides Evotec with the largest global footprint in infectious disease capabilities in the industry and a broad pipeline of drug candidates and discovery projects.

Evotec’s partnered programmes are progressing well as demonstrated by significant milestone achievements in its strategic iPSC alliances with Sanofi in the field of diabetes (TargetBCD) and with Celgene in neurodegeneration. Evotec continues to place great emphasis on the expansion and development of its iPSC platform and patient-centric approaches to drug discovery.

In addition, Evotec’s academic BRIDGE model continues to attract significant interest from academia and industry partners. LAB031, the first French BRIDGE, was formed in October 2018 (after period-end) in partnership with Sanofi. Evotec’s existing BRIDGEs LAB282, LAB150 and LAB591 also recorded progress with projects selected for future activities in the course of the first nine months of 2018.

3. CORPORATE
CONVERSION INTO EUROPEAN COMPANY (SE) ON TRACK
Mandatory negotiation processes with a Special Negotiation Board (SNB) are ongoing regarding the future arrangements for employee involvement, after which Evotec AG will be transferred into Evotec SE with the registered seat and headquarters remaining in Hamburg, Germany.

CHANGE IN MANAGEMENT BOARD AS OF 01 JANUARY 2019: APPOINTMENT OF DR CRAIG JOHNSTONE AS NEW COO; DR MARIO POLYWKA RETIRING
Following the departure of Dr Mario Polywka as Evotec’s COO effective 31 December 2018, the Supervisory Board of Evotec will appoint Dr Craig Johnstone as its new Chief Operating Officer and member of the Management Board, effective 01 January 2019. Dr Johnstone is a successful drug discovery leader with over 20 years’ experience. Dr Johnstone joined Evotec in May 2012 as SVP Drug Discovery and Innovation Efficiency and was appointed Directeur General and Site Head, Evotec France, in April 2015. In January 2017, he was appointed Global Head, Integrated Drug Discovery at Evotec. Between 1994 and 2012, Dr Johnstone served in a number of projects, functions, matrix and leadership roles at AstraZeneca, Prosidion and Rapier Research. He holds a BSc in Chemistry and a PhD in organic and organometallic synthesis and has published more than 70 patents.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "On behalf of the Management Board and the Company, I would like to sincerely thank Mario for his outstanding contributions, strong commitment to the Company and very valuable insights, which helped Evotec to become the leader in external innovation. He has been an essential part of our Management Team and we are very thankful for him being such a passionate force driving Evotec’s development. We will closely stay in touch with him and we wish him all the best for all of his future endeavours, amongst others remaining a consultant to Evotec. Moreover, I am delighted to welcome Craig to our team as new Chief Operating Officer."

On November 13, 2018 ISA Pharmaceuticals B.V., a clinical-stage immuno-oncology company, reported that its Chief Scientific Officer Prof. Cornelis Melief has been selected by the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) to receive the 2018 ESMO (Free ESMO Whitepaper) Immuno-Oncology Award in recognition of his life’s work in studying the interactions of the immune system with cancer (Press release, ISA Pharmaceuticals, NOV 13, 2018, View Source [SID1234531236]). He will receive the award during an official ceremony at the opening keynote and award lecture of this year’s ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress in Geneva, Switzerland, on December 13, 2018 (01:30-01:45 pm CET, Hall A2 – Room A). The title of his lecture will be "Combination immunotherapy of cancers caused by high risk human papilloma virus".

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Prof. Melief will be the second recipient of the ESMO (Free ESMO Whitepaper) Immuno-Oncology Award, which was created in 2017 in commemoration of European cancer research and treatment pioneer Prof. Georges Mathé, a founding member of ESMO (Free ESMO Whitepaper).

In addition to his role at ISA Pharmaceuticals, Prof. Melief is Professor Emeritus in tumor immunology at the Leiden University Medical Center in the Netherlands. He focuses on the development of effective immunotherapies for virus-induced tumors and has created the concept of synthetic long peptide (SLP) vaccines for the treatment of cancer patients. Prof. Melief and his team were able to show the clinical effectiveness of these therapeutic vaccines in patients with pre-malignant lesions caused by Human Papilloma Virus type 16 (HPV-16).

Among the most promising results obtained to date, Melief and his team found that a combination of SLP vaccination and standard chemotherapy strengthened cervical cancer patients’ immune response and prolonged their survival. They further discovered that a similar effect could be achieved among patients with HPV-related head and neck cancer by administering the vaccines in conjunction with immunotherapy in the form of immune system boosting monoclonal antibodies.

Prof. George Coukos and John Haanen, Scientific Co-Chairs of the upcoming congress, outlined the reasons for nominating Cornelis Melief:

"Professor Melief dedicated his career to understanding how the immune system, specifically cytotoxic lymphocytes, interact with cancer, and used this knowledge for the development of new therapeutic cancer vaccine strategies," said Coukos.

"With this award, we are recognizing him as a true pioneer in the field of cancer immunology, who has trained and inspired a whole generation of young scientists with his research," Haanen added.

"This is a great honor and a wonderful recognition of the fact that after many years of concept building and evaluation in lab models and investigational trials, we have finally arrived at immunotherapy approaches that can make a difference for patients," said Prof. Cornelis Melief. "To me, this award also means recognition of the outstanding teamwork delivered by talented investigators at Leiden University Medical Center and ISA Pharmaceuticals as well as by many medical oncologists in the Netherlands, Belgium and the USA."

On November 13, 2018 VBL Therapeutics (Nasdaq: VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that it will host a conference call and live audio webcast on Tuesday, November 20 at 8:30am Eastern Time to report third quarter ended September 30, 2018 financial results and to provide a corporate update (Press release, VBL Therapeutics, NOV 13, 2018, View Source [SID1234531235]).

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Tuesday, November 20th @ 8:30am Eastern Time
US Domestic: 888-204-4368
International: 323-994-2082
Conference ID: 4933637
Webcast: View Source

Replays, Available through December 4th, 2018
US Domestic: 844-512-2921
International: 412-317-6671
Conference ID: 4933637

On November 13, 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 third quarter 2018 (Press release, BerGenBio, NOV 13, 2018, View Source [SID1234531234]). 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 of our phase II clinical development programme with our selective AXL inhibitor bemcentinib, particularly in NSCLC. The observed correlation between patient response and positive AXL status in our combination trial with KEYTRUDA gives us confidence in bemcentinib’s proposed mode of action and its broad appeal as a promising new agent treating aggressive cancer. The next six to nine months will be an exciting time for the company as we anticipate further clinical data from our phase II trials, particularly in NSCLC and acute myeloid leukaemia."

Highlights – Third Quarter & 2018
Bemcentinib/KEYTRUDA combination in advanced non-small cell lung cancer (NSCLC) delivers highly promising phase II clinical results

40% overall response rate & 70% clinical benefit rate observed in AXL-positive, previously treated NSCLC patients, including PD-L1 negative patients (data presented at World Conference on Lung Cancer (WCLC))
5.9 months median progression-free-survival (PFS) in AXL positive vs. 3.3 months in AXL negative patients presented as late breaking abstract at Society Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) congress (SITC, post-period)
Efficacy endpoint met and stage two of the trial actively enrolling
Additional lung cancer phase II trials show promise for bemcentinib in combination with chemo- and targeted agents

Median PFS of NSCLC patients receiving the bemcentinib/TARCEVA combination in first line has surpassed that of TARCEVA monotherapy (data presented at WCLC)
Encouraging efficacy reported for bemcentinib in combination with docetaxel chemotherapy in patients who had exhausted all available therapy options (data presented at WCLC)
Tissue- and blood-based biomarkers with potential for development as companion diagnostics

Novel biomarkers identified and qualified across multiple clinical trials with bemcentinib, presented as poster discussion at European
Society for Medical Oncology meeting (ESMO) (Free ESMO Whitepaper) and SITC (Free SITC Whitepaper) 2018 (post period)
Arbitration process with Rigel Pharma Inc.

The Company is seeking clarification of interpretation and application of certain provisions of the 2011 bemcentinib license agreement
Anticipated data and news flow in the coming months

AML and MDS mono- and combination therapy at ASH (Free ASH Whitepaper) 2018
Stage 2 of bemcentinib/KEYTRUDA combination trial in H1 2019
IND filed for BGB149, first in class AXL function blocking antibody (post period)
Financial Highlights (Figures in brackets = same period 2017 unless otherwise stated)

Total operating expenses for the third quarter were NOK 38.1 million (NOK 36.6 million). Total operating expenses for the first nine months of 2018 amounted to NOK 143.6 million (NOK 136.2 million)
Research and development expenses accounted for 75.3 % of total operating expenses in Q3, and 72.3 % for the first nine months of 2018
Comprehensive loss for the third quarter amounted to NOK 37.7 million (loss of NOK 35.4 million). Comprehensive loss for the first nine months of 2018 was NOK 140.7 million (loss of NOK 134.6 million)
Cash and cash equivalents amounted to NOK 398.2 million at the end of September 2018 (NOK 440.3 million at 30 June 2018 and NOK 370.3 million at 31 December 2017)
Presentation and Webcast Details

A presentation by BerGenBio’s senior management team will take place at 10.00 am CET at:

Hotel Continental, Stortingsgaten 24/26, 0117 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.

END

About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms that drive aggressive and life-threatening diseases. In cancer, AXL drives tumour survival, treatment resistance and spread, as well as suppressing the body’s immune response to tumours. AXL expression has been established as a negative prognostic factor in many cancers. AXL inhibitors, therefore, have potential value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities