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Test Number : A4040-129
Test denomination : Accessment: IBM i 7.1 Administration
Vendor denomination : IBM
braindumps : 164 Dumps Questions

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Accessment: IBM i 7.1 Administration book

Affimed reviews 2d Quarter 2019 monetary and Operational results | A4040-129 Dumps and true exam Questions with VCE drill Test

Heidelberg, Germany, August 7, 2019 - Affimed N.V. (Nasdaq: AFMD), a scientific stage biopharmaceutical traffic dedicated to giving sufferers again their hereditary potential to fight cancer, these days said fiscal and operating results for the 2nd quarter ended June 30, 2019.

“After achieving condense with the U.S. food and Drug Administration on the spy at protocol design, they at the minute are in the system of making ready to provoke the AFM13 registration-directed section 2 examine,” notable Dr. Adi Hoess, Affimed’s CEO. “The synchronous advantageous final and interim results from two medical experiences of AFM13 add to the growing to be carcass of proof aiding AFM13’s recreation in CD30-advantageous lymphoma patients, and provide us accelerated self assurance within the talents of AFM13 to display clinical benefit in CD30-high quality peripheral T cellphone lymphoma. To execute the section 2 study and to further enhance their inner and partnered CD16A-concentrated on hereditary phone engager pipeline, we've enormously bolstered their corporation through the addition of discrete key hires within the U.S. and Germany of people who've huge drug development adventure.”

corporate Updates

-- Affimed strengthened its drug development group with the addition of experienced personnel in a number of key areas, together with Regulatory Affairs, medical development and Operations, Drug safety, Chemistry, Manufacturing and control (CMC), Drug protection & Pharmacovigilance, Biostatistics and industrial approach. the brand new hires in the past held positions at Novartis, Pfizer Inc., Abbott, Eli Lilly and enterprise and different massive pharmaceutical or biotechnology businesses. -- In April, Affimed received a fee from Genentech caused by means of the success of a preclinical milestone beneath its analysis collaboration to boost and commercialize novel natural killer (NK) cellphone engager-based mostly immunotherapeutics in keeping with Affimed’s ROCK® platform to handle diverse cancers. -- Affimed was brought to the Russell 2000®, Russell 3000®, and Russell Microcap® Indexes, positive after the U.S. markets closed on Friday, June 28, 2019 as a portion of Russell’s annual index rebalance manner. Russell U.S. Indexes are yardstick with the aid of investment managers and institutional traders as the groundwork for index dollars and as benchmarks for energetic investment innovations. -- In June 2019, Affimed’s subsidiary AbCheck entered into a five-12 months licensing settlement with Icosagen granting AbCheck access to Icosagen’s QMCF protein construction know-how. below the terms of the agreement, AbCheck acquires the rights to utilize Icosagen’s QMCF know-how platform for its industrial actions in antibody discovery.

Pipeline Updates

CD16A hereditary telephone engager classes

AFM13 (CD30/CD16A)

-- Affimed reached condense with the U.S. food and Drug Administration involving the design of its planned section 2 registration-directed spy at of AFM13 as monotherapy in relapsed or refractory patients with CD30-tremendous peripheral T mobile lymphoma (PTCL). The results, if high quality, could kindly the foundation for a Biologics License application (BLA) submission and lead an accelerated approval given the unmet clinical requisite for secure and constructive new treatments in this difficult-to-deal with patient inhabitants. The examine will besides unite a cohort of sufferers with modified mycosis fungoides, an aggressive subtype of cutaneous T phone lymphoma. spy at beginning-up actions are under means, with spy at commencement predicted within the second half of 2019. -- up-to-date facts from an investigator-backed translational section 1b/2a spy at of AFM13 in sufferers with relapsed or refractory CD30-advantageous lymphoma with cutaneous manifestation led by using Columbia tuition was presented at the overseas convention on Malignant Lymphomas (ICML) in Lugano in June 2019. The information Tested single-agent endeavor of AFM13 in CD30-advantageous lymphoma sufferers, with an goal response rate (ORR) of 50% (5 out of 10 patients). Tumor biopsies showed extended infiltration of NK cells in responders in comparison to non-responders, and evidence of NK mobilephone-mediated killing. -- Affimed stated the remaining outcomes from the portion 1b dose escalation examine of AFM13 plus pembrolizumab that confirmed encouraging efficacy within the intent-to-deal with (ITT) patient population (n=30) with an ORR of 83%, together with finished responses (CR) in 40% and partial responses (PR) in forty three% of patients with difficult-to-treat Hodgkin lymphoma. on the maximum treated dose (n=24), patients showed an ORR of 88% (CR of forty six% and PR of forty two%) as decided through unbiased evaluation. usual, the aggregate of AFM13 and pembrolizumab showed a favorable protection profile in sufferers, including some sufferers who didn't respond to first-line chemotherapy and a subgroup of patients who were simple refractory to brentuximab vedotin. Importantly, a deepening of responses turned into suggested over time in dissimilar patients. furthermore, sufferers up to now transplant-ineligible transitioned to transplant after reaching an objective response with the admixture of AFM13 and pembrolizumab, as a consequence increasing the probability for a cure. These high quality effects, taken along side facts demonstrating single-agent exercise of AFM13 in CD30-tremendous T cell lymphoma sufferers, contour the groundwork for Affimed to provoke a registration-directed anatomize of AFM13 as monotherapy in sufferers with PTCL. -- The admixture of AFM13 with allogeneic NK cells represents a novel approach with a purpose to further Boost response fees and durability of responses in sufferers with relapsed/refractory CD30-advantageous lymphoma. In a preclinical collaboration with the university of Texas MD Anderson cancer middle (MDACC), AFM13 has been shown to bind to CD16A with a powerful deal bigger affinity than other CD16A binding moieties akin to monoclonal antibodies, thus enabling the formation of a trustworthy advanced of AFM13 pre-combined with cord blood-derived allogeneic NK cells. This sturdy complicated showed exotic efficacy in in vitro and in vivo experiments, forming the basis for an investigator-backed aspect 1 spy at by course of MDACC. within the examine, MDACC intends to manage this trustworthy knotty in distinctive doses (numbers of pre-loaded NK cells) into patients with relapsed/refractory CD30-high-quality malignancies.

AFM24 (EGFR/CD16A)

-- AFM24 is a tetravalent, bispecific EGFR- and CD16A-binding hereditary cellphone engager from Affimed’s ROCK® platform. it is designed to target EGFR-expressing stout tumors through a brand new mechanism of action that activates hereditary immunity. this is a differentiated strategy from cetuximab and different EGFR targeting techniques that inhibit tumor growth by EGFR-mediated signal transduction. Affimed offered facts at the American affiliation for melanoma research (AACR) 2019 Annual assembly that validated AFM24’s means to bridge NK cells and macrophages to EGFR expressing tumor mobilephone traces and result in lysis through antibody-dependent cellular cytotoxicity (ADCC) and antibody-elegant mobile phagocytosis (ADCP), respectively. as a result of AFM24’s discrete mode of action these consequences acquire been independent of RAS mutational reputation. Importantly, AFM24 more advantageous tumor infiltration of NK cells and elicited dose-based anti-tumor efficacy in in vivo tumor fashions. AFM24 showed reduced inhibition of EGFR phosphorylation relative to the monoclonal antibody cetuximab. treatment of cynomolgus monkeys with AFM24 resulted in a favorable safety profile, even when treated at exorbitant dose ranges, demonstrating AFM24’s potential to acquire vastly subside toxicities in people compared to regular of care. Affimed currently anticipates submitting the investigational new drug (IND) application for AFM24 around the conclusion of the third quarter 2019.

know-how Updates

-- information describing Affimed’s ROCK® antibody platform become posted in the mAbs journal, titled, “Redirected optimized cellphone killing (ROCK®): A enormously multifaceted multispecific healthy-for-aim antibody platform for attractive hereditary immunity.” The paper discusses points of the modular platform, together with the advantages of hereditary immune cell rendezvous over monoclonal antibodies and other engager ideas. The article besides describes the talents of the ROCK® platform to engineer a fit-for-goal hereditary immune cellphone engager layout that may besides be geared up with exciting CD16A domains, modules that acquire an upshot on pharmacokinetic houses and molecular architectures that influence the activation of immune effectors, as well as tumor concentrated on. The article is attainable at: https://doi.org/10.1080/19420862.2019.1616506.

monetary Highlights

(Figures for the 2nd quarter and 6 months ended June 30, 2019 and 2018 are unaudited.)

cash, money equivalents and existing fiscal property totaled €87.7 million as of June 30, 2019, in comparison to €108.8 million as of December 31, 2018. based on its present operating and price purview assumptions, Affimed anticipates that its cash, cash equivalents and present fiscal assets as of June 30, 2019 will permit the company to fund its deliberate scientific pile and early pile activities into 2021.

net money used in operating activities become €18.9 million for the six months ended June 30, 2019, compared to net money used in working actions of €15.2 million for the six months ended June 30, 2018. The raise is basically because of better cash expenditure for analysis and development efforts.

complete earnings become €4.0 million for the three months ended June 30, 2019 compared to €0.2 million for the three months ended June 30, 2018. The enhance in salary is because of the focus of €three.7 million as salary from the Genentech collaboration within the second quarter of 2019.

research and pile (R&D) prices for the 2d quarter of 2019 acquire been €11.5 million, including collected termination costs of €1.four million associated with the wind-down activities for both section 1 reports of AFM11. R&D costs for the 2d quarter of 2018 acquire been €7.1 million. The raise turned into essentially concerning bigger prices regarding manufacturing actions for medical study fabric for AFM13, startup actions for the AFM13 registration examine in PTCL, early stage pile and discovery actions, and the termination prices for both AFM11 medical stories.

frequent and administrative (G&A) costs for the second quarter of 2019 had been essentially unchanged at €2.three million in comparison to €2.2 million for the second quarter of 2018.

net loss became €10.3 million, or €0.17 per common share, for the 2nd quarter of 2019, in comparison to a internet loss of €8.0 million, or €0.13 per natural share, for the second quarter of 2018.

word on IFRS Reporting StandardsAffimed prepares and reviews the consolidated pecuniary statements and monetary assistance based on alien monetary Reporting necessities (IFRS) as issued by course of the overseas Accounting standards Board (IASB). not one of the monetary statements were prepared in response to generally permitted Accounting ideas (GAAP) in the united states. Affimed maintains its books and data in Euro.

convention denomination and Webcast suggestions

Affimed will host a conference denomination and webcast today, Wednesday, August 7, 2019 at eight:30 a.m. jap time to talk about the company’s economic effects and exact company traits. To access the call, tickle dial +1 (917) 720-0178 for U.S. callers, or +forty four (0) 203 0095710 for alien callers, and reference conference identification 9396039 about 15 minutes just before the name. An audio webcast of the convention denomination can besides be accessed within the “Webcasts” portion on the “traders” page of the Affimed web site at https://www.affimed.com/buyers/webcasts/. A replay of the webcast will be purchasable on Affimed’s website shortly after the conclusion of the denomination and should be archived for 30 days following the call.

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical company dedicated to giving sufferers again their hereditary talent to combat cancer. Affimed’s healthy-for-aim ROCK® platform allows for hereditary mobilephone engagers to be designed for certain patient populations. The company is setting up sole and combination therapies to deal with hematologic and stout tumors. For more advice, tickle argue with www.affimed.com.

forward-searching STATEMENTS

This press unencumber consists of forward-looking statements. outright statements other than statements of historical reality are ahead-searching statements, which are sometimes indicated through phrases reminiscent of "expect," "consider," "could," "estimate," "predict," "aim," "intend," "look ahead to", "may additionally," "plan," "skills," "predict," "mission," "should," "will," "would" and an identical expressions. forward-looking statements look in a few locations throughout this unlock and comprehend statements concerning their intentions, beliefs, projections, outlook, analyses and existing expectations concerning, among different issues, the cost of their ROCK® platform, their ongoing and planned preclinical construction and scientific trials, their collaborations and pile of their items in combination with other treatment plans, the timing of and their skill to execute regulatory filings and obtain and hold regulatory approvals for their product candidates their intellectual property position, their collaboration activities, their skill to enhance industrial capabilities, expectations concerning clinical visitation facts, their outcomes of operations, cash wants, pecuniary situation, liquidity, possibilities, future transactions, extend and techniques, the industry by which they operate, the developments that can besides acquire an upshot on the traffic or us and the risks uncertainties and other components described below the heading “possibility factors” in Affimed’s filings with the Securities and trade fee. Given these risks, uncertainties and other factors, execute certain you now not vicinity undue reliance on these ahead-looking statements, and they assume no duty to update these ahead-looking statements, despite the fact that new suggestions becomes purchasable sooner or later.

Affimed Investor Contact:Gregory Gin, Head of Investor RelationsE-Mail: IR@affimed.com

Affimed Media Contact:Anca Alexandru, Head of Communications, ecu IRE-Mail: media@affimed.com

Affimed N.V.Unaudited consolidated statements of comprehensive earnings/(loss) (in € thousand)

For the three months For the six months ended June 30 ended June 30 2019 2018 2019 2018 revenue four,008 a hundred and fifty 15,361 682 other earnings – internet 197 forty nine 283 38 analysis and construction (11,545) (7,149) (19,532) (13,545) fees accepted and administrative (2,342) (2,164) (four,776) (four,202) expenses -------- - ------- ------------- ---------- operating salary / (loss) (9,682) (9,114) (eight,664) (17,027) Finance revenue / (charges) – net (654) 1,a hundred one hundred eighty 811 profits / (loss) before tax (10.336) (eight,014) (8,484) (sixteen,216) profits taxes (four) 0 (four) (1) -------- - ------- ------------- ---------- income / (loss) for the term (10,340) (8,014) (eight,488) (sixteen,217) -------- - ------- ------------- ---------- different finished income / (loss) items that usually are not reclassified to profit or loss (49) 406 24 211 fairness investments at reasonable cost OCI – web alternate in unbiased cost -------- - ------- ------------- ---------- other finished revenue / (forty nine) 406 24 211 (loss) -------- - ------- ------------- ---------- complete comprehensive salary / (10,389) (7,608) (8,464) (16,006) (loss) -------- - ------- ------------- ---------- revenue / (loss) per participate in (0.17) (0.13) (0.28) € per participate (0.14) (undiluted = diluted) Weighted variety of common shares 62,439,363 sixty two,390,068 62,434,734 58,614,053 fantastic

Affimed N.V.Consolidated statements of economic dwelling (in € thousand)

June 30, 2019 December 31, 2018 (unaudited) property Non-latest property Intangible assets 168 56 Leasehold improvements and machine 1,960 1,414 future economic belongings three,849 three,825 correct-of-use assets 653 0 6,630 5,295 existing property cash and cash equivalents 63,987 94,829 fiscal assets 23,726 13,974 trade and different receivables 1,471 1,429 Inventories 330 260 other property 2,973 387 92,487 a hundred and ten,879 total property 99,117 116,174 fairness AND LIABILITIES fairness Issued capital 624 624 Capital reserves 240,235 239,055 reasonable cost reserves 2,618 2,594 amassed deficit (210,632) (202,a hundred and forty four) total fairness 32,845 40,129 Non-latest liabilities Borrowings 323 1,690 condense liabilities 39,138 37,512 lease liabilities 246 0 -------------- ----------------- complete non-current liabilities 39,707 39,202 current liabilities change and other payables 7,541 9,425 Provisions 1,440 0 Borrowings three,552 3,083 hire liabilities 377 0 condense liabilities 13,655 24,335 complete latest liabilities 26,565 36,843 total fairness AND LIABILITIES ninety nine,117 116,174

Affimed N.V.Unaudited consolidated statements of money flows (in € thousand)

For the six months ended June 30 2019 2018 money stream from working activities income / (loss) for the duration (eight,488) (16,217) adjustments for the length: - earnings taxes 4 1 - Depreciation and amortisation 423 199 - net benefit from disposal of leasehold advancements and gadget (9) 0 - participate based funds 1,167 937 - Finance income / fees – web (a hundred and eighty) (811) -------- -------- (7,083) (15,891) alternate in trade and different receivables 228 88 exchange in inventories (70) (26) exchange in other property (2,586) (1,159) change in exchange, other payables, provisions and condense liabilities (9,484) 1,970 -------- -------- money utilized in operating actions (18,995) (15,018) activity received 188 fifty eight Paid interest (134) (196) internet cash utilized in working actions (18,941) (15,156) cash circulation from investing activities buy of intangible assets (142) (26) buy of leasehold advancements and machine (755) (298) cash bought from the sale of leasehold advancements 0 1 and gadget money paid for investments in fiscal assets (35,262) 0 cash obtained from maturity of fiscal belongings 25,748 0 net cash used for investing activities (10,411) (323) cash stream from financing activities Proceeds from challenge of accustomed shares 13 25,042 Transaction fees involving rigor of regular shares 0 (1,686) Proceeds from borrowings 562 0 repayment of hire liabilities (206) 0 repayment of borrowings (1,649) (1,500) -------- -------- cash circulation from financing actions (1,280) 21,856 -------- -------- alternate-price connected adjustments of money and cash equivalents (210) 1,198 net changes to cash and money equivalents (30,632) 6,377 cash and cash equivalents at the birth of the length ninety four,829 39,837 money and cash equivalents on the conclusion of the term 63,987 forty seven,412 -------- --------

Affimed N.V.Unaudited consolidated statements of changes in equity (in € thousand)

Issued capital Capital reserves amassed deficit unbiased value reserves total fairness steadiness as of January 468 213,778 7,325 (182,667) 38,904 1, 2018 -------------- ---------------- ------------------- ------------------- ------------ 23,one hundred ninety 23,346 concern of mediocre 156 shares equity-settled participate primarily based 937 937 fee awards Loss for the length (16,217) (16,217) different finished 211 211 earnings -------------- ---------------- ------------------- ------------------- ------------ equipoise as of June 624 237,905 7,536 (198,884) 47,181 30, 2018 -------------- ---------------- ------------------- ------------------- ------------ stability as of January 624 239,055 (202,144) 40,129 1, 2019 2,594 -------------- ---------------- ------------------- ------------------- ------------ recreation of participate 13 13 primarily based price awards fairness-settled participate based mostly 1,167 1,167 price awards Loss for the length (8,488) (eight,488) other comprehensive 24 24 earnings -------------- ---------------- ------------------- ------------------- ------------ equipoise as of June 30, 2019 240,235 2,618 (210,632) 32,845 624 -------------- ---------------- ------------------- ------------------- ------------


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