Evotec AG reports first nine-month 2018 results and corporate updates

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."

ISA Pharmaceuticals´ Chief Scientific Officer Prof. Cornelis Melief Receives ESMO Immuno-Oncology Award 2018

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."

VBL Therapeutics to Report Third Quarter 2018 Financial Results on November 20

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

BerGenBio ASA: Results for the Third Quarter 2018

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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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

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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

Jounce Therapeutics Reports Third Quarter 2018 Financial Results

On November 13, 2018 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results and provided a corporate update for the third quarter ended September 30, 2018 (Press release, Jounce Therapeutics, NOV 13, 2018, View Source [SID1234531231]).

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"We are pleased to announce continued advancement across our development programs including JTX-2011, JTX-4014 and JTX-8064. While we complete our biomarker and clinical data analysis on JTX-2011, safety dose escalation cohorts are proceeding as planned to enable us to pursue new combination trials. Additionally, we filed an IND for our internal PD-1 program, JTX-4014, and recently received clearance from the FDA to proceed with a Phase 1 dose escalation trial. Our lead tumor-associated macrophage program, JTX-8064, targeting LILRB2, is on track to be our third IND," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We are committed to our vision and firmly believe there is strong promise for our translational science approach to transform the treatment of cancer. Based on this progress, we are well-positioned to advance both our clinical and discovery program efforts in 2019."

Corporate and Development Highlights:

JTX-2011 Dose Escalation Cohorts Progressing: As previously announced, in June 2018, Jounce began the enrollment of dose escalation cohorts evaluating the safety of JTX-2011 in combination with ipilimumab and in combination with pembrolizumab, and these studies are progressing as planned.

Newly Reported Data Confirms Mechanism of Action of JTX-2011: At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd annual meeting in November, Jounce presented new data from ICONIC patients demonstrating the agonistic properties of JTX-2011. These data are in addition to the subset analysis data presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June demonstrating the emergence of ICOS hi CD4 T cells in the blood of all patients with ≥30% target lesion tumor reductions, both in patients treated with JTX-2011 monotherapy and in combination with nivolumab. The ICOS hi CD4 T cells were not observed in patients with primary progressive disease.
Through additional reverse translational studies, presented at SITC (Free SITC Whitepaper), Jounce established two key insights that provide the scientific foundation for the next stage of development of JTX-2011.

jouncelogosmaller.jpg


First, the emergence of these ICOS hi CD4 T cells was related to JTX-2011, as it has not been detected in a separate study Jounce conducted of responding and non-responding patients that received PD-1/L1 inhibitor monotherapy treatment; and

Second, in vitro experimental data showed that JTX-2011 only activates CD4 T cells if they already express high levels of ICOS.
Additionally, new preclinical tumor model data presented in a separate poster at SITC (Free SITC Whitepaper), strengthens Jounce’s belief that agents that induce ICOS hi CD4 T cells detectable in the bloodstream, such as anti-CTLA-4, may be attractive combination partners for JTX-2011.

JTX-4014 IND Filed and Cleared: Jounce filed an Investigational New Drug (IND) application for JTX-4014, its PD-1 inhibitor, in September 2018. In October 2018, the U.S. Food and Drug Administration (FDA) concluded that Jounce may proceed with a Phase 1 dose escalation trial. Jounce will initiate this trial as the next key step for this program.

JTX-8064 IND Filing on Track: Jounce continues to advance its first tumor-associated macrophage candidate targeting Leukocyte Immunoglobulin Like Receptor B2 (LILRB2) from its Translational Science Platform through IND-enabling studies. JTX-8064 is a selective antagonist antibody that demonstrates preclinical characteristics of reprogramming immune suppressive macrophages in the tumor microenvironment.

Jounce Founders Awarded 2018 Nobel Prize and Coley Award: In October 2018, Jounce founder Dr. James P. Allison was jointly awarded the 2018 Nobel Prize in Physiology or Medicine for the discovery of cancer therapy by inhibition of negative immune regulation. Also in October 2018, Jounce founder Dr. Padmanee Sharma was awarded the William B. Coley Award for Distinguished Research in Tumor Immunology for her innovative work understanding factors that enhance and hinder cancer immunotherapy.

Third Quarter 2018 Financial Results:

Cash Position: As of September 30, 2018, cash, cash equivalents and investments were $214.7 million, compared to $257.9 million as of December 31, 2017. Cash was utilized for operating costs incurred during the period, offset by the receipt of state and federal income tax refunds.

Collaboration Revenue: Collaboration revenue was $14.5 million for the third quarter of 2018, compared to $18.1 million for the same period in 2017. Collaboration revenue represents revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s global strategic collaboration with Celgene.

Research and Development (R&D) Expenses: R&D expenses were $16.8 million for the third quarter of 2018, compared to $17.1 million for the same period in 2017. The decrease in R&D expenses was due to $1.5 million of decreased lab consumables offset primarily by $0.5 million of increased stock-based compensation expense, $0.3 million of increased external clinical and regulatory expenses related to the Phase 1/2 ICONIC trial and $0.4 million of increased other research expenses primarily due to license and milestone payments associated with preclinical programs.

General and Administrative (G&A) Expenses: G&A expenses were $6.5 million for the third quarter of 2018, compared to $5.4 million for the same period in 2017. The increase in G&A expenses was primarily due to $1.2 million of increased employee compensation costs, including $0.8 million of increased stock-based compensation expense.

jouncelogosmaller.jpg


Net Loss: Net loss was $7.6 million for the third quarter of 2018, or a basic and diluted net loss per share attributable to common stockholders of $0.23. Net loss was $4.1 million for the same period in 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.13. The increase in net loss and net loss per share attributable to common stockholders is primarily attributable to the decrease in non-cash collaboration revenue and the increase in operating expenses from the third quarter of 2017 to the third quarter of 2018.

Financial Guidance:
Jounce continues to expect to end the year with approximately $185.0 to $195.0 million in cash, cash equivalents and investments. Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements for at least the next 24 months.

Jounce is reiterating its 2018 collaboration revenue guidance of approximately $50.0 to $60.0 million.

Conference Call and Webcast Information:
Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 4689666. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.