On August 9, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the first half of 2018 (Press release, Evotec, AUG 9, 2018, View Source;announcements/press-releases/p/evotec-ag-reports-first-half-year-2018-results-and-corporate-updates-5709 [SID1234528620]).

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STRONG FINANCIAL PERFORMANCE FROM BOTH SEGMENTS
Group revenues: 67% increase to € 173.8 m (H1 2017: € 104.3 m);
EVT Execute revenues up 61% to € 163.3 m (H1 2017: € 101.3 m);
EVT Innovate revenues up 52% to € 32.0 m (H1 2017: € 21.1 m)
Adjusted Group EBITDA up 47% to € 38.6 m (H1 2017: € 26.2 m);
Adjusted EBITDA for EVT Execute of € 36.3 m (H1 2017: € 28.6 m);
Adjusted EBITDA for EVT Innovate of € 2.3 m (H1 2017: € (2.4) m)
Group R&D expenses up 17% to € 10.0 m (H1 2017: € 8.5 m)
Very strong performance in Q2 2018 due to Aptuit contribution, milestone achievements and signing of new partnerships
Acquisition loan from 2017 repaid by 50% (partially after period-end) mainly from operational cash flows
Strong liquidity position of € 109.8 m

EVT EXECUTE
Clinical Phase I and Phase II starts in Bayer alliance and strong progress within ongoing alliances (e.g. Forge, Dermira, C4X, Blackthorn, Abivax)
New and extended drug discovery and development agreements (e.g. Katexco)
Continued strong performance of high-throughput ADME-tox testing (Cyprotex, an Evotec company)
Aptuit integration according to plan:
Positive development of business and good uptake of INDiGO solution to accelerate drug candidate delivery (e.g. Carna Biosciences, Petra Pharma); expansion of INDiGO capacity initiated

EVT INNOVATE
Takeover of Sanofi’s infectious disease unit effective 01 July 2018, creating largest global footprint in infectious disease capabilities plus a broad project pipeline – Evotec at the same time receives an upfront payment of € 60 m (after period-end) and R&D cost coverage for the first five years
New long-term partnership with Celgene in oncology with upfront payment of $ 65 m
Important milestone achievements (e.g. iPSC diabetes alliance with Sanofi, iPSC neurodegeneration alliance with Celgene)
Continued focus on expansion of iPSC platform and patient-centric approaches to drug discovery
Academic BRIDGE model continues momentum (e.g. expansion of funded projects under LAB150 and LAB282; LAB591 as first US BRIDGE established)

CORPORATE
Conversion into European Company (SE) initiated

GUIDANCE UPDATE H2 2018
Guidance on Group revenues – Growth of >30% confirmed
Guidance on adjusted Group EBITDA – Growth of approx. 30% confirmed
Guidance on R&D expenses increased – R&D expenses for 2018 will increase to € 35-45 m (from € 20-30 m) due to investments in newly started anti-infectives initiatives; there will be no impact on adjusted Group EBITDA since the costs for the first five years will be covered by Sanofi

1. STRONG FINANCIAL PERFORMANCE FROM BOTH SEGMENTS

Evotec’s Group revenues for the first half of 2018 grew to € 173.8 m, a significant increase of 67% compared to the same period of the previous year (H1 2017: € 104.3 m). This increase is due to a strong performance in the base business, a positive Aptuit contribution (€ 53.6 m) as well as increased milestone achievements in existing alliances. The total revenues from milestones, upfronts and licences for the first half of 2018 amounted to € 15.5 m and increased by 17% over the same period of the previous year (H1 2017: € 13.3 m). In the first six months of 2018, the gross margin amounted to 28.9% (H1 2017: 35.7%). This margin change compared to 2017 reflects 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 amounted to 32.5%. The second quarter of 2018 recorded a very strong financial performance. Group revenues increased by 78% to € 94.8 m (Q2 2017: € 53.4 m), following the Aptuit contribution, strong milestone achievements and the signing of new partnerships (e.g. Celgene partnership in oncology). The significant milestone achievements were also reflected in the gross margin of Q2 2018 of 33.6% (Q2 2017: 34.1%). Q2 2018 gross margin excluding total amortisation amounted to 36.7% (Q2 2017: 37.1%). The adjusted Group EBITDA increased from € 12.8 m in the second quarter of 2017 to € 24.6 m in the second quarter of 2018.

R&D expenses for the first half of 2018 increased by 17% to € 10.0 m (H1 2017: € 8.5 m) reflecting continued development of predominantly initiatives in the fields of CNS and metabolic diseases as well as a focus on academic BRIDGE initiatives. SG&A expenses for the first half of 2018 increased as expected by 72% to € 27.1 m (H1 2017: € 15.8 m). Q2 2018 SG&A expenses remained on a similar level as in Q4 2017 and Q1 2018, which were the first full quarters following the Aptuit acquisition. SG&A expenses in the first six months of 2018 were mainly impacted by the addition of Aptuit as well as an increase in headcount in response to overall Company growth.

In the first six months of 2018, Evotec recorded impairments of intangible assets of € 4.2 m in total (H1 2017: € 0.0 m). The EVT770 programme was fully impaired (€ 4.0 m) as the project was put on hold. 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. The developed assets within the Panion joint venture were fully impaired (€ 0.2 m) as it was decided to discontinue the one programme.

Evotec’s adjusted Group EBITDA in the first six months of 2018 significantly increased by 47% to € 38.6 m (H1 2017: € 26.2 m). Evotec’s operating result for the first half of 2018 amounted to € 21.7 m (H1 2017: € 18.4 m). The net result in the first half of 2018 increased to € 17.9 m (H1 2017: € 10.3 m).

Liquidity, which includes cash and cash equivalents (€ 91.3 m) and investments (€ 18.5 m) amounted to € 109.8 m at the end of June 2018 (31 December 2017: € 91.2 m). On 31 July 2018, Evotec announced the repayment of 50% of the € 140 m debt facility, which was taken to fund the acquisition of Aptuit in 2017. This repayment was enabled mainly through the strong cash inflow from Evotec’s operational activities in the first half of 2018; in addition, part of the loan has been refinanced at highly attractive terms.

In the first half of 2018, revenues from the EVT Execute segment amounted to € 163.3 m, an increase of 61% compared to the same period of the previous year (H1 2017: € 101.3 m). This increase is primarily attributable to the strong performance in the base business and the Aptuit contribution for the first six months of 2018. Included in this amount are € 21.5 m of intersegment revenues (H1 2017: € 18.0 m). The EVT Execute segment recorded costs of revenue of € 126.8 m in the first six months of 2018 (H1 2017: € 71.6 m), resulting in a gross margin of 22.4% (H1 2017: 29.3%). The drivers behind this change in gross margin are the same drivers, which affected the Group gross margin. In the first six months of 2018, the EVT Execute segment recorded a significant upswing of its adjusted EBITDA of 27% to € 36.3 m against the prior-year period (H1 2017: € 28.6 m).

The EVT Innovate segment generated revenues in the amount of € 32.0 m (H1 2017: € 21.1 m), consisting entirely of third-party revenues. This 52% increase in EVT Innovate revenues primarily resulted from milestone achievements in key alliances in the first half of 2018. The EVT Innovate segment reported costs of revenue of € 15.9 m (H1 2017: € 11.4 m), resulting in a gross margin of 50.4% compared to 46.1% in the prior-year period. R&D expenses for the EVT Innovate increased from € 10.4 m in the first six months of 2017 to € 12.0 m in the first six months of 2018. The EVT Innovate segment reported a positive adjusted EBITDA of € 2.3 m (H1 2017: € (2.4) m) mainly due to milestone achievements. All key projects to achieve significant milestones in 2018 are on track.

2. EVT EXECUTE & EVT INNOVATE
EVT EXECUTE
In the first half of 2018, the EVT Execute segment continued its strong operational performance of the previous quarters. The Aptuit integration into the Evotec Group is proceeding according to plan. Evotec’s INDiGO offering, which was part of the strategic rationale behind the Aptuit acquisition, was launched in March 2018 and has started to attract very good interest from the industry, resulting in new INDiGO deals being signed with Carna Biosciences and Petra Pharma, among others. INDiGO is an integrated and highly efficient process to IND submission. In addition, Aptuit’s stand-alone development services and integrated CMC continued to deliver and sign new programmes. The expansion of the Active Pharmaceutical Ingredient ("API") capacity volume in Oxford and Verona will be completed in the second half of 2018, affording significant important scale to maximise on INDiGO opportunities. The Cyprotex business (acquired in December 2016) has continued its excellent performance of the previous quarters.

Good progress was achieved in Evotec’s existing alliances (e.g. Forge, Dermira, C4X, Blackthorn, Abivax) and new and expanded alliances were also signed (e.g. Katexco). In Evotec’s 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 (after period-end). Since the beginning of the collaboration in 2012, six first-in-class/best-in-class non-hormonal pre-clinical candidates have been generated, out of which three programmes have progressed into Phase I/Phase II clinical trials.

EVT INNOVATE
The EVT Innovate segment also had a very strong first half of 2018. Significant progress was recorded across the various different ventures within this segment.

With the closing of the agreement with Sanofi in infectious diseases effective 01 July 2018 triggering an upfront of € 60 m (€ 43 m in cash plus € 17 m cash of the acquired company), Evotec now has the largest global footprint in infectious disease capabilities in the industry and a broad pipeline of drug candidates and discovery projects. Furthermore, Evotec broadened its existing relationship with Celgene with the start of a major long-term strategic agreement with Celgene in oncology resulting in an upfront payment of $ 65 m. This collaboration leverages Evotec’s phenotypic screening capabilities and unique compound libraries as well as associated target deconvolution capabilities.

Evotec’s existing key programmes are also on track, demonstrated by significant milestone achievements in the strategic iPSC alliance with Sanofi in the field of diabetes (TargetBCD) (milestone payment of € 3 m) and in the iPSC-based alliance with Celgene in neurodegeneration (milestone payment of $ 6 m). Evotec continues to place great emphasis on the expansion and development of its iPSC platform and patient-centric approaches to drug discovery.

Evotec’s academic BRIDGE model continues to attract significant interest from academia and industry partners. LAB591, the first US-based BRIDGE, was formed in May in partnership with Fred Hutchinson and Arix Bioscience. Evotec’s existing BRIDGES LAB282 and LAB150 also recorded progress with projects being selected for future activities in the course of the first six months of 2018.

3. CORPORATE
CONVERSION INTO EUROPEAN COMPANY (SE) INITIATED
At the Annual General Meeting held on 20 June 2018 in Hamburg, Evotec’s shareholders voted to support the conversion of Evotec AG into a European Company with a majority of 99.96%. After finalising the mandatory negotiation process regarding the future arrangements for employee involvement, Evotec AG will be transferred into Evotec SE with the registered seat and headquarters remaining in Hamburg, Germany.

4. GUIDANCE UPDATE H2 2018
Following the closing of the agreement to take over Sanofi’s infectious disease unit, the financial guidance 2018 was updated. Evotec now expects R&D expenses to range from € 35-45 m (previously: € 20-30 m). All other elements of the guidance 2018 are confirmed. In particular, the additional R&D efforts are not expected to impact the adjusted EBITDA since these extra R&D expenses will be covered by other operating income recognised in context of this new agreement with Sanofi.

Webcast/Conference Call
The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

Conference call details

Date: Thursday, 09 August 2018

Time: 02.00 pm CEST (01.00 pm BST/08.00 am EDT)

From Germany: +49 69 22 22 29 043

From France: +33 170 750 705

From Italy: +39 023 601 3806

From UK: +44 20 3009 2452

From USA: +1 855 402 7766

Access Code: 37969784#

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our homepage www.evotec.com shortly before the event.

A replay of the conference call will be available for 24 hours and can be accessed in Europe by dialling +49 69 22 22 33 985 (Germany) or +44 20 3426 2807 (UK) and in the USA by dialling +1 866 535 8030. The access code is 654573#. The on-demand version of the webcast will be available on our website: View Source

Note: The 2017 and 2018 results are not fully comparable. The difference stems from the acquisition of Aptuit, effective 11 August 2017. The results from Aptuit are only included from 11 August 2017 onwards. The accounting policies used to prepare this interim information are the same as those used to prepare the audited consolidated financial statements for the year ended 31 December 2017, except for the adoption of new standards effective as of 01 January 2018.

From 01 January 2018 onwards, Evotec applies IFRS 15. The comparison period 2017 is adjusted from the first time application of IFRS 15.

On August 9, 2018 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing novel small molecule therapeutics to treat unmet needs in autoimmunity and cancer, reported its second quarter 2018 business highlights and financial results (Press release, Kezar Life Sciences, AUG 9, 2018, View Source [SID1234528613]).

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"The second quarter of 2018 marked multiple milestones for Kezar as we continue to execute on our strategy of developing our first-in-class selective immunoproteasome inhibitor for patients with severe autoimmune diseases. Enrollment is underway in KZR-616-002, our Phase 1b/2 trial in lupus (SLE) and lupus nephritis (LN), with top-line results from the initial two cohorts of the Phase 1b expected in the first half of 2019," said John Fowler, CEO of Kezar. "We remain on track to initiate our first randomized trial in LN, an area of high unmet medical need, in 2019. Finally, during this quarter we added key members to our management team and completed our IPO, which strengthened our balance sheet and will enable us to initiate clinical trials in up to four additional autoimmune indications also beginning in 2019."

Business Highlights

Enrollment of patients with SLE with and without nephritis to the open-label dose escalation Phase 1b portion of the clinical trial KZR-616-002 (NCT03393013), continued in the second quarter. This trial is being conducted in the United States and includes a randomized, placebo-controlled Phase 2 portion in patients with active, proliferative LN.

In May, the Company announced the appointments of Niti Goel, MD, as Chief Medical Officer and Marc Belsky as Chief Financial Officer. Dr. Goel will be responsible for Kezar’s overall regulatory, clinical development and medical affairs activities, and Mr. Belsky will head the finance and administrative functions of the Company.

In June, the Company completed its initial public offering (IPO) of 5,750,000 shares of its common stock, including the exercise in full of the underwriters’ option to purchase 750,000 additional shares of common stock, at a public offering price of $15.00 per share. The gross proceeds to Kezar, before deducting underwriting discounts, commissions and offering expenses, were approximately $86.3 million.

Financial Results

Cash Position. Cash, cash equivalents and marketable securities totaled $118.4 million as of June 30, 2018, compared to $51.0 million as of December 31, 2017. The increase in cash, cash equivalents and marketable securities was primarily attributable to IPO proceeds, net of cash used by the Company in operations to advance its clinical stage programs as well as preclinical research and development.

R&D Expenses. Research and development expenses for the second quarter of 2018 increased by $3.8 million to $5.2 million from $1.4 million in the second quarter of 2017. This increase was primarily related to advancing the KZR-616 clinical program.

G&A Expenses. General and administrative expenses for the second quarter of 2018 increased by $1.3 million to $1.7 million from $0.4 million in the second quarter of 2017. This increase was primarily related to costs incurred to complete the IPO.

Net Loss. Net loss for the second quarter of 2018 was $6.8 million, or $3.31 per basic and diluted share, compared to a net loss of $1.9 million, or $3.30 per basic and diluted share, for the second quarter of 2017.

Shares Outstanding. Total shares outstanding were 19.1 million as of June 30, 2018. Additionally, there were 2.2 million options to purchase common stock at a $3.70 weighted average exercise price as of June 30, 2018.

On August 9, 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 second quarter ended June 30, 2018 (Press release, Jounce Therapeutics, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363021 [SID1234528610]).

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"We recently reported safety and preliminary efficacy data from our lead program, JTX-2011, at ASCO (Free ASCO Whitepaper) in June and are pleased to announce that enrollment is now underway in the dose escalation cohorts of the Phase 1/2 ICONIC trial evaluating the safety of JTX-2011 in combination with ipilimumab and in combination with pembrolizumab. For the broader pipeline derived from our Translational Science Platform, we remain on track to file an IND for JTX-4014 this year and are conducting IND-enabling studies for our first tumor-associated macrophage candidate," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "Our experienced and talented team remains focused on our key value drivers as we work to discover and develop first-in-class immunotherapies. We remain committed to interrogating the tumor microenvironment to inform and refine our clinical trials and, ultimately, impact the lives of cancer patients."

Ongoing Phase 1/2 ICONIC Trial of JTX-2011:

In June 2018, Jounce began enrollment of dose escalation cohorts evaluating the safety of JTX-2011 in combination with ipilimumab and in combination with pembrolizumab.

In June 2018, Jounce presented safety and preliminary efficacy data from its ongoing Phase 1/2 ICONIC (ICOS AgONist Antibody for Immunotherapy in Cancer Patients) trial, an adaptive design, open-label trial evaluating JTX-2011 alone and in combination with nivolumab in patients with advanced solid tumors. The Phase 1 portion of ICONIC was a dose escalation study to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The patients in Phase 2 received JTX-2011 0.3 mg/kg every 3 weeks alone or in combination with nivolumab 240 mg every 3 weeks. Preliminary efficacy evaluation included tumor reductions and response evaluation criteria in solid tumors (RECIST) responses. Key data included:

Safety: JTX-2011 was well tolerated alone and in combination with nivolumab 240 mg every 3 weeks. The overall safety profile observed was consistent with previously reported data from the Phase 1 portion of the ICONIC trial.

Biological and Clinical Activity: The patients with RECIST partial responses (PRs), alone and in combination with nivolumab, reported at ASCO (Free ASCO Whitepaper), remained on study with ongoing response. The RECIST PRs were seen in PD-1 inhibitor naïve patients with Gastric and Triple Negative Breast cancers. In addition, tumor reductions and stable disease have occurred including in patients with Non-Small Cell Lung cancers who are PD-1 inhibitor failures.

Biomarkers: In a preliminary analysis of evaluable fresh pre-treatment biopsies, rates of disease control and tumor reduction appear higher in subjects with high ICOS scores. A potential ICOS pharmacodynamic biomarker (emergence of a peripheral blood ICOS high CD4 T cell population) that appears to associate with anti-tumor activity has been identified.
Additional Pipeline Highlights:

Jounce remains on track to file an Investigational New Drug (IND) application for JTX-4014, its internal anti-PD-1 antibody in the second half of 2018.

In March 2018, Jounce advanced its first, tumor associated macrophage candidate from its Translational Science Platform into IND-enabling studies.
Second Quarter 2018 Financial Results:

Cash Position: As of June 30, 2018, cash, cash equivalents and investments were $232.7 million, compared to $257.9 million as of December 31, 2017. This decrease was due to operating costs incurred during the quarter, offset by the receipt of state and federal income tax refunds.

Collaboration Revenue: Collaboration revenue was $19.4 million for the second quarter of 2018, compared to $20.3 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. Under Accounting Standards Codification Topic 606, Revenue from Contracts with Customers, which was adopted in the first quarter of 2018, Jounce has transitioned from recognizing revenue on a straight-line basis to recognizing revenue based on the pattern of performance under the global strategic collaboration with Celgene. Jounce is reiterating its 2018 collaboration revenue guidance of approximately $50.0 to $60.0 million.

Research and Development (R&D) Expenses: R&D expenses were $18.5 million for the second quarter of 2018, compared to $17.2 million for the same period in 2017. The increase in R&D expenses was primarily due to $1.0 million in increased employee compensation costs related to increased headcount and $0.2 million in increased external research and development costs primarily attributable to IND-enabling activities related to JTX-4014.

General and Administrative (G&A) Expenses: G&A expenses were $6.5 million for the second quarter of 2018, compared to $6.1 million for the same period in 2017. The increase in G&A expenses was primarily due to increased stock-based compensation expense.

Net Loss: Net loss was $4.7 million for the second quarter of 2018, or a basic and diluted net loss per share attributable to common stockholders of $0.14. Net loss was $3.4 million for the same period in 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.11. The increase in 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 second quarter of 2017 to the second quarter of 2018.
Financial Guidance:

In March 2018, Jounce provided gross cash burn guidance for 2018 of $80.0 to $100.0 million. This cash burn projection excluded any tax refund impact. During the second quarter of 2018, Jounce received tax refunds of $16.8 million relating to taxes previously paid on the Celgene upfront payment. These refunds resulted from a change in tax accounting method elected as a result of the Tax Cuts and Jobs Act of 2017.

Jounce expects to now be at the lower end of the gross cash burn guidance previously provided and expects 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.

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 8881737. 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.

Cautionary Note Regarding Forward-Looking Statements:

Various statements in this release concerning Jounce’s future expectations, plans and prospects, including without limitation, Jounce’s expectations regarding operating expenses, capital expenditures, collaboration revenue, cash burn and other financial results, the timing and progress of the Phase 1/2 ICONIC trial, the filing of an IND for JTX-4014 and the timing, progress and results of preclinical studies and clinical trials for Jounce’s product candidates and any future product candidates may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward looking statements, which often include words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "on track," "plan," "predict," "target," "potential" or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates and future product candidates, the preclinical and clinical results for its product candidates, which may not support further development and marketing approval, the potential advantages of Jounce’s product candidates, the development plans of its product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Jounce’s ability to obtain, maintain and protect its intellectual property, Jounce’s ability to manage operating expenses, Jounce’s ability to maintain its collaboration with Celgene, as well as those risks more fully discussed in the section entitled "Risk Factors" in Jounce’s most recent annual or quarterly report and in other reports that Jounce has filed with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

On August 9, 2018 argenx (Euronext & Nasdaq: ARGX) a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that the Company will present on Tuesday, August 14th at 1:20 p.m. ET at the 2018 Wedbush PacGrow Healthcare Conference in New York (Press release, argenx, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363190 [SID1234528607]).

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A live webcast of the presentation will be available on the Company’s website at www.argenx.com. A replay of the webcast will be available for 90 days following the presentation.

On August 9, 2018 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results for the second quarter ended June 30, 2018 and highlighted recent company achievements (Press release, GlycoMimetics, AUG 9, 2018, View Source [SID1234528603]). Quarter-end cash at June 30, 2018 was $229.4 million.

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"Our second-quarter 2018 accomplishments reflect significant progress as we finalized our plans to conduct a comprehensive Phase 3 development program for uproleselan across the spectrum of AML. With our announcement in May of an NCI CRADA, in addition to the previously announced trial in Europe sponsored by the prestigious HOVON consortium and our own sponsored registration trial, we are now planning three separate randomized, controlled trials, which we believe should provide clear efficacy and safety outcome measures in each of settings being evaluated," said Rachel King, GlycoMimetics Chief Executive Officer. "The unique mechanism of action of uproleselan allows for the potential treatment of not only relapsed/refractory AML patients, but also older, newly diagnosed AML patients who are considered to be either fit or unfit for intensive chemotherapy. If successful, we believe that the combination of these trials could position us to offer a new standard treatment across the continuum of care in AML."

Key Operational Highlights for the Second Quarter of 2018:

The company’s agreement with the NCI, part of the National Institutes of Health (NIH), provides for GlycoMimetics to collaborate with both the NCI and the Alliance for Clinical Trials in Oncology to conduct a randomized, controlled clinical trial testing the addition of uproleselan to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are eligible for intensive chemotherapy. The trial will be funded by the NCI. GlycoMimetics will provide uproleselan as well as financial support to augment data analysis and monitoring. Geoffrey Uy, M.D., Associate Professor of Medicine, Bone Marrow Transplantation and Leukemia, Washington University School of Medicine in St. Louis, will lead this Phase 3 trial. The primary endpoint will be overall survival, with a planned interim analysis based on event-free survival (EFS) after the first 250 patients have been enrolled in the study.
At the AACR (Free AACR Whitepaper) annual meeting, the company highlighted data from preclinical models of selected cancers in which uproleselan and GMI-1359, a dual antagonist of E-selectin and CXCR4, exhibited anti-cancer activity. Key findings from the preclinical research include:
Uproleselan could potentially be used with a hypomethylating agent, such as 5-azacitidine, to treat AML patients not healthy enough for intensive chemotherapy.
GMI-1359 mobilized tumor-reactive T-cells from bone marrow, which could enhance effectiveness of treatments despite tumor resistance.
Both tumor growth and metastasis of osteosarcoma to lung tissue were reduced with GMI-1359 treatment.
The company’s strategic partner Pfizer continues to enroll individuals with sickle cell disease (SCD) in its Phase 3 clinical study of rivipansel for the treatment of vaso-occlusive crisis (VOC). Pfizer has advised GlycoMimetics that enrollment is approximately 75% complete and is estimated to be completed in early 2019, with top-line data expected to be available in the second quarter of 2019.
Second Quarter 2018 Financial Results:

Cash position: As of June 30, 2018, GlycoMimetics had cash and cash equivalents of $229.4 million as compared to $123.9 million as of December 31, 2017. In March 2018, GlycoMimetics completed a public offering of 8,050,000 shares of common stock, yielding net proceeds of $128.4 million.
R&D Expenses: The Company’s research and development expenses increased to $9.3 million for the quarter ended June 30, 2018 as compared to $5.7 million for the prior year quarter. The increase was primarily due to higher manufacturing costs for uproleselan clinical supplies as the Company prepares for our planned Phase 3 clinical trial and to meet our supply obligations for clinical trials of uproleselan conducted by or in collaboration with third parties. This increase was offset in part by a decrease in clinical trial expenses as patient enrollment for our Phase 1/2 clinical trial of uproleselan was completed in May 2017.
G&A Expenses: The Company’s general and administrative expenses increased to $2.8 million for the quarter ended June 30, 2018 as compared to $2.5 million for the prior year quarter. The increase was primarily due to higher patent and other legal expenses.
Shares Outstanding: Shares outstanding as of June 30, 2018 were 43,055,424.
The company will host a conference call and webcast tomorrow, Friday, August 10, 2018, at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) with passcode 3876308. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

About Uproleselan (GMI-1271)

Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed/refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, which have been derived from results from third party clinical trials evaluating standard chemotherapy, as well as lower than expected induction-related mortality rates. Treatment in these patient populations was generally well tolerated, with fewer than expected adverse effects. The FDA has granted uproleselan Breakthrough Therapy designation for the treatment of adult AML patients with relapsed/refractory (R/R) disease. GlycoMimetics plans to implement a comprehensive development program across the clinical spectrum of AML. This will include a company sponsored Phase 3 trial in R/R AML and two consortia-sponsored trials in newly diagnosed patients. One consortium trial will be sponsored by the NCI and will enroll newly diagnosed patients fit for intensive chemotherapy. The other trial will be sponsored by the HOVON group in Europe and will enroll newly diagnosed patients unfit for intensive chemotherapy.

About Rivipansel

Rivipansel, the most advanced drug candidate in the GlycoMimetics pipeline, is a glycomimetic drug candidate that acts as a pan-selectin antagonist, meaning it binds to all three members of the selectin family – E-, P- and L-selectin. The first potential indication for rivipansel is VOC of SCD, one of the most severe complications of SCD which can result in acute ischemic organ injury at one or more sites. By reducing cell adhesion, activation and inflammation that are believed to contribute to reduced blood flow through the microvasculature during VOC, GlycoMimetics believes that rivipansel could be the first drug to interrupt the underlying cause of VOC, thereby potentially enabling patients to leave the hospital more quickly. Pfizer is conducting a Phase 3 clinical trial for rivipansel in SCD.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules that keep cancer cells in the bone marrow. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma (MM) or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer. GMI-1359 is currently in Phase 1 testing in healthy volunteers.