On August 6, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported its financial results for the second quarter of 2019 (Press release, MorphoSys, AUG 6, 2019, View Source [SID1234538250]).

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"MorphoSys continued to make excellent progress on multiple fronts in the second quarter of 2019," said Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "A major step was the appointment of my successor Dr. Jean-Paul Kress as the new CEO of MorphoSys, effective September 1, 2019. Jean-Paul brings a wealth of medical, commercial and leadership expertise and I have every confidence that he will enable MorphoSys to make great strides in the execution of its strategy, especially in the launch and commercialization of our lead program tafasitamab. Topline results from the primary analysis of our L-MIND trial, followed by the presentation of the complete data set at the recent ICML conference, confirmed the potential of this program. We remain on track to completing our BLA filing to FDA by the end of this year and today we also confirmed our intention to submit a Marketing Authorization Application based on L-MIND to the European Medicines Agency. For the B-MIND trial, we have disclosed the biomarker we have implemented as a low baseline peripheral blood natural killer cell count, which may help us to identify patients who could benefit from tafasitamab’s potential efficient recruitment of these cells. Finally, our agreement with Vivoryon Therapeutics, which gives us access to a family of small molecule inhibitors in immuno-oncology, is a potentially invaluable addition to our proprietary portfolio. We are keen to assess the potential of these compounds in combination with our antibodies, first and foremost with tafasitamab", Dr. Moroney continued.

"The L-MIND data we have reported represent a key catalyst for the transformation of MorphoSys and our goal to develop into a fully integrated biopharmaceutical company. Our preparations to further broaden the development of tafasitamab are ongoing and the start of a first line trial in DLBCL is expected later this year. We are also broadening our development of MOR202, which we plan to test in a phase 1/2 clinical trial in a chronic inflammatory autoimmune disease of the kidneys later this year," commented Jens Holstein, Chief Financial Officer of MorphoSys AG. "Our balanced business model is based on the value of our Partnered Discovery segment that allows us to invest in the development and planned commercialization of our proprietary portfolio. The milestone payment of EUR22 million from GSK following the phase 3 start in rheumatoid arthritis with otilimab, formerly MOR103, led us to increase our financial guidance. An increasing royalty stream from Tremfya(R) further strengthens our cash position and we are confident that there will be other compounds that follow Tremfya’s(R) market entry in the future."

Financial Review for the second quarter of 2019 (IFRS; all figures rounded)

In Q2 2019 MorphoSys continued to focus on the research and development of drug candidates both for its own account as well as with its partners. Group revenues increased to EUR34.7 million in Q2 2019 as compared to EUR8.1 million in the second quarter of the previous year. The increase was mainly driven by the milestone payment of EUR22 million from GSK due to the start of the clinical phase 3 program with otilimab (MOR103) in rheumatoid arthritis (RA). This payment was recognized in the second quarter due to the provisions of IFRS 15 on revenues from variable consideration.

Revenues also included an estimate of royalties on net sales of Tremfya(R) amounting to EUR 7.1 million (estimate only since royalties for Q2 2019 had not been reported by Janssen as of the balance date).

In the Proprietary Development segment, MorphoSys focuses on research into, and clinical development of, its own drug candidates in the fields of cancer and inflammation. In Q2 2019, this segment recorded revenues of EUR25.9 million (Q2 2018: EUR0.1 million). In the Partnered Discovery segment, MorphoSys applies its proprietary technology to discover new drug candidates for pharmaceutical companies, benefiting from its partners’ development advancements through R&D funding, licensing fees, success-based milestone payments and royalties. In Q2 2019, revenues in this segment amounted to EUR8.7 million (Q2 2018: EUR8.1 million).

Total operating expenses were EUR40.3 million in the second quarter of 2019 (Q2 2018:
EUR32.7 million). In Q2 2019, research and development expenses amounted to EUR24.7 million, as compared to EUR25.8 million in the second quarter of 2018. Expenses for proprietary R&D, including technology development, amounted to EUR22.5 million (Q2 2018: EUR23.7 million). In the second quarter of 2019, cost of sales amounted to EUR4.9 million (in Q2 2018, this item did not exist), selling expenses amounted to EUR3.2 million (Q2 2018: EUR1.5 million). General and administrative expenses increased from EUR5.5 million in Q2 2018 to EUR7.5 million in Q2 2019.

Earnings before interest and taxes (EBIT) in Q2 2019 was -EUR5.7 million (Q2 2018: -EUR24.1 million). The Proprietary Development segment reported an EBIT of -EUR7.0 million (Q2 2018:
-EUR24.6 million). EBIT in the Partnered Discovery segment was EUR6.3 million (Q2 2018: EUR5.5 million). In Q2 2019, the consolidated net result was -EUR5.9 million (Q2 2018:
-EUR23.5 million). The earnings per share for Q2 2019 was -EUR0.19 (Q2 2018: -EUR0.76).

At the end of Q2 2019, the Company had EUR409.2 million in cash, reported on the balance sheet under the line items "cash and cash equivalents"; "financial assets at fair value through profit or loss"; and current and non-current "other financial assets at amortized cost". On December 31, 2018, the Group’s liquidity position amounted to EUR454.7 million.

The number of shares issued totaled 31,839,572 at the end of Q2 2019 (year-end 2018: 31,839,572).

Results for the first six months 2019

During the first six months of 2019, group revenues increased to EUR48.2 million (Q1-Q2 2018: EUR10.9 million). Revenues in the first half of 2019 comprised the milestone payment by GSK of EUR22.0 million due to the start of phase 3 clinical development of otilimab in RA. Expenditure for proprietary R&D, including technology development, amounted to EUR45.1 million in the first six months of 2019 (Q1-Q2 2018: EUR39.2 million). Consequently the EBIT in the first six months of 2019 amounted to -EUR29.3 million, compared to -EUR43.2 million in the first half of 2018.

Financial Guidance and Operational Outlook for 2019

Following a milestone payment of EUR22 million made by GSK on July 3, 2019 that was triggered by the start of phase 3 clinical development of otilimab (MOR103), MorphoSys increased its financial guidance. For the year 2019, MorphoSys expects revenues in the range EUR65 to 72 million (up from previously EUR43 to 50 million), and EBIT of -EUR105 to -115 million (from previously -EUR127 to -137 million). Expenses for proprietary development and technology development are expected to remain in a corridor of EUR95 to 105 million.

The guidance does not include revenues from potential future partnership or licensing agreements for tafasitamab or any other compound currently in MorphoSys’s Proprietary Development segment. Effects from potential in-licensing or co-development deals for new development candidates are also not included.

In its Proprietary Development segment, MorphoSys expects the following events and activities until the end of 2019:

Tafasitamab (MOR208)

L-MIND trial
Submission of Biologics License Application to U.S. FDA by year-end
Presentation of headline data from virtual, lenalidomide-only control arm planned for year-end
B-MIND trial
Continue phase 3 study evaluating tafasitamab plus bendamustine in r/r DLBCL
Event-driven interim analysis expected to occur in Q4 2019
Front-line DLBCL: Initiate phase 1b trial of tafasitamab in combination with R-CHOP or R2-CHOP in Q4 2019
COSMOS: Continue phase 2 trial of tafasitamab in combination with idelalisib or venetoclax in r/r CLL/SLL, with data to be presented at a medical conference at the end of 2019
MOR202

MorphoSys: Start a clinical phase 1/2 trial of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN) in Q4 2019
I-Mab: Continue two clinical trials of MOR202/TJ202 in multiple myeloma in the Chinese region
MOR106

Continue phase 2 intravenous IGUANA study, phase 1 subcutaneous bridging study and the recently started phase 2 GECKO trial as well as prepare for a Japanese ethno-bridging study in atopic dermatitis together with Galapagos and under global licensing agreement with Novartis

In its Partnered Discovery segment, MorphoSys expects the following events until end of 2019:

According to information provided on clinicaltrials.gov, by the end of 2019 primary completion may be reached in up to eight clinical trials in phases 2 and 3 from partners evaluating antibodies made using MorphoSys’s technology. These include:

A potentially pivotal phase 2b study by Mereo BioPharma in osteogenesis imperfecta (brittle bone syndrome) of the HuCAL antibody setrusumab (BSP804) directed against sclerostin (this antibody was generated within the scope of MorphoSys’s partnership with Novartis and subsequently licensed from Novartis to Mereo),
Further phase 3 trials of Tremfya(R) conducted by Janssen in psoriatic arthritis and a potential submission of a BLA planned for later this year as communicated by Janssen.
Moreover, Janssen plans the start of a phase 1 trial of guselkumab in Chinese healthy volunteers, a phase 2 trial of guselkumab in pityriasis rubra pilaris, a phase 2/3 trial in ulcerative colitis and a phase 3 trial in palmoplantar-non-pustular psoriasis, according to clinicaltrials.gov.

Whether, when and to what extent news will be published following the primary completion of trials in the Partnered Discovery segment is at the full discretion of MorphoSys’s partners.

MorphoSys will continue to support its proprietary development activities by evaluating potential in-licensing, co-development, and/or acquisition opportunities or the potential initiation of new proprietary development programs with the goal of maintaining and expanding the Company’s position in its current therapeutic and technological fields of activities.

1) Including MOR107, which concluded a phase 1 study in 2017 and is currently in preclinical investigation with a focus on oncology indications. Tremfya(R) is still considered as a clinical program due to ongoing studies in various indications.

2) Including otilimab (MOR103/GSK3196165), which is fully out-licensed to GSK, and MOR106, for which MorphoSys and Galapagos have signed a global licensing agreement with Novartis.

PP – Percentage points

MorphoSys will hold its conference call and webcast tomorrow, August 7, 2019 to present the second quarter financial results 2019 and a further outlook for 2019.

Dial-in number for the analyst conference call (in English) at 2:00pm CEST; 1:00pm BST; 8:00am EDT:

Germany: +49 69 201 744 220
For UK residents: +44 203 009 2470
For US residents: +1 877 423 0830
Participant PIN: 43166710#

Please dial in 10 minutes before the beginning of the conference.

A live webcast and slides will be made available at View Source

Approximately two hours after the call, a slide-synchronized audio replay of the conference and a transcript will be available at View Source

The Half-Year Report 2019 (IFRS) is available online at
View Source

On August 6, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported the closing of a private placement in the form of convertible bonds with an aggregate principal amount of 18 billion Korean Won (KRW) (approximately USD $15 million based on the current exchange rate) issued to institutional investors led by Korea Investment Partners (KIP), a global venture capital and private equity firm based in Seoul, Korea, with additional offices in Shanghai, China and Sunnyvale, California (Press release, Inovio, AUG 6, 2019, View Source [SID1234538249]). Inovio expects to use the proceeds of the investment for the continued advancement of development activities for its clinical-stage product pipeline and for working capital and other general corporate purposes. Inovio today also announced its intent to pursue a secondary listing of its securities on the KOSDAQ Market of the Korea Exchange (KOSDAQ) in the form of Korean Depositary Receipts (KDRs).

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Dr. J. Joseph Kim, Inovio’s President and CEO, said, "We are pleased to have received this investment from fundamental, long-only institutional investors led by KIP and we appreciate their conviction. This additional funding will help Inovio advance a number of our clinical programs toward commercialization as we continue to strengthen Inovio on becoming the ‘go-to’ immunotherapeutic solution provider for all major HPV-related conditions with VGX-3100 (Phase 3), MEDI0457 (Phase 2 with AstraZeneca) and INO-3107."

Dr. Kim added, "The Korean capital market represents an expanding opportunity for Inovio to secure a new and attractive source of capital. Given our history of strategic partnerships and clinical development in Asia, especially in Korea, Inovio is well-positioned to tap into this new source of capital. This opportunity will also expand Inovio’s presence in Asia and further our goal of becoming a global contributor to the fight against cancer and emerging infectious diseases."

Mahnsoon Hwang, Senior Managing Director specializing in Biotechnology and Healthcare for KIP, said, "We are excited by Inovio’s diverse portfolio and growth prospects of its transformative DNA Immunotherapy platform. Given the exponential growth that we have seen over the last couple of years in Korea for anti-cancer drugs and immunotherapies, we believe Inovio is well-positioned to capture the market opportunity, while continuing to build on its already established Asian partnerships."

The bonds, which are unsecured obligations of Inovio, were issued on August 1, 2019 and will accrue interest at a coupon rate of 1.00% per annum, payable quarterly. The bonds will mature on July 31, 2024, unless earlier converted or repurchased. Starting August 1, 2020, the bonds will be convertible at any time after the first anniversary of the issue date until the date that is one month prior to the maturity date. Upon conversion, Inovio will deliver KDRs, assuming Inovio has KDRs listed on KOSDAQ at that time, or otherwise shares of common stock, if KDRs are not listed on KOSDAQ at that time. The initial conversion rate will be 211.0595 shares per KRW1,000,000 principal amount of bonds (equivalent to an initial conversion price of approximately USD $4.00 per share based on the exchange rates as of July 30, 2019), subject to adjustment upon the occurrence of specified events. The bonds will be subject to repurchase by Inovio at the option of the noteholders from and including July 31, 2022 up to the maturity date at a repurchase price equal to the principal of the bonds to be repurchased plus a premium on such bonds in order to ensure an internal rate of return with respect to such bonds of 6.00%.

This press release shall not constitute, nor form any part of, an offer to sell, the solicitation of an offer to buy or solicitation activity relating to any of the securities mentioned herein (including, for the avoidance of doubt, any securities convertible from the convertible bonds), nor shall there be any sale of any such securities (including, for the avoidance of doubt, any securities convertible from the convertible bonds) in any state or other jurisdiction (including Korea) in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction (including Korea).

About Korea Investment Partners (KIP)

Korea Investment Partners (KIP), a member of Korea Investment Holdings, is a Venture Capital firm investing in and promoting growth of promising companies for the past 30 years. The venture capital firm operates from global offices situated in Seoul, Shanghai, Beijing, and Sunnyvale-California. KIP is managing over 20 funds with a total size over USD $1.5 billion. Every year, KIP invests in about 50 companies from Korea, China and the U.S. With a portfolio that spans across 30 years, KIP has managed over 20 private equity funds and invested in over 500 companies.

On August 6, 2019 MorphoSys Discloses Biomarker to Stratify Patient Population in B-MIND Study of Tafasitamab plus Bendamustine in r/r DLBCL (Press release, MorphoSys, AUG 6, 2019, View Source [SID1234538248]).

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MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported specifications of the biomarker that was implemented in the currently ongoing phase 3 B-MIND study. B-MIND compares the efficacy of tafasitamab (MOR208) plus bendamustine versus rituximab plus bendamustine in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL). The biomarker, which is the basis for a co-primary endpoint, is described as a low baseline peripheral blood natural killer (NK) cell count and was implemented in agreement with the FDA as an amendment of B-MIND in the first quarter of this year.

Patients with a low number of NK cells (defined as 100 or fewer NK cells per microliter blood) at study entry represent approximately 50% of the overall study population and are believed to exhibit a less favorable response to anti-CD20-based therapies. Pre-clinical data generated at MorphoSys suggests that tafasitamab’s potential to more efficiently recruit effector cells, predominantly NK cells, may therefore be of particular benefit for this patient population.

The co-primary endpoint allows for efficacy testing in the overall patient population as originally planned, and also in those patients with a low NK cell count at baseline. An event-driven interim analysis is expected to occur in Q4 2019 following a longer than expected duration of response in the overall patient population.

"Patients with r/r DLBCL who are not eligible for high dose chemotherapy and autologous stem cell transplantation have a poor prognosis, which is even worse for patients who are characterized by a low baseline NK cell count. The enhanced NK cell recruitment that tafasitamab is believed to exert through its ENFORCERTM format may activate even minimal NK cell numbers, which could potentially translate into enhanced activity against tumor cells," said Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "The amendment of the B-MIND study allows us to test this hypothesis and potentially to provide a benefit for a distinct patient population that does not have targeted treatment alternatives."

About B-MIND
The phase 3 B-MIND study is designed to investigate the CD19 antibody tafasitamab in combination with bendamustine versus a combination of the CD20 antibody rituximab plus bendamustine in patients with r/r DLBCL who are not eligible for high dose chemotherapy and autologous stem cell transplantation. The biomarker had been implemented in agreement with the FDA in the first quarter of 2019. The pre-planned, event-driven interim analysis of B-MIND is expected to take place in the fourth quarter of 2019. In case the overall study population passes the futility analysis, an event-driven primary analysis of the study is expected in late Q1 2020. In case the overall study population fails, but the biomarker subpopulation passes the futility analysis, the study will continue, but an increase from 330 to 450 patients is required, in which case an event-driven primary analysis of the study is expected in Q1 of 2021. Only if both groups do fail the interim analysis for futility the overall study can be considered futile.

On August 6, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported its intention to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) based on its phase 2 L-MIND study of tafasitamab (MOR208) and lenalidomide in relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) (Press release, MorphoSys, AUG 6, 2019, View Source [SID1234538247]). A letter of intent was submitted to EMA in early July and MorphoSys plans to complete the MAA submission by mid-2020.

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L-MIND is a single-arm, open-label phase 2 study investigating the antibody tafasitamab in combination with lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma who are not eligible for high-dose chemotherapy and autologous stem cell transplantation. In July 2019, the company presented positive primary analysis data from L- MIND at the ICML conference in Lugano. These data will form the basis for the planned filing package of the MAA that, if granted, allows for earliest approval in Europe in 2021.

"We are excited about the progress we are making with our plan for a possible regulatory approval for tafasitamab in Europe," said Dr. Malte Peters, Chief Development Officer at MorphoSys. "The preceding constructive interaction with the European regulatory authorities has given us the confidence to pursue an MAA submission for approval in Europe based on L-MIND. This complements our current focus on seeking approval of tafasitamab in the U.S. on the basis of L-MIND, for which we will complete a BLA submission to the FDA by year-end."

On August 6, 2019 Lixte Biotechnology Holdings, Inc. (OTCQB: LIXT) reported that it signed a clinical trial agreement with the Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas, GEIS) to support a Phase 1b/randomized Phase 2 study of doxorubicin, the global standard for initial treatment of advanced soft tissue sarcomas (ASTS), versus doxorubicin plus LB-100 (Press release, Lixte Biotechnology, AUG 6, 2019, View Source [SID1234538246]).

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Dr. John S. Kovach, CEO of Lixte, said, "We are pleased to support this investigator-initiated trial proposed by GEIS, a leader for many years in seeking improved therapies for ASTS. GEIS has a network of referral centers in Spain and across Europe that has an impressive track record of efficiently conducting innovative studies in ASTS. We believe GEIS and their EU collaborators are an excellent team to evaluate the potential benefit of adding Lixte’s non-cytotoxic inhibitor of DNA damage repair to standard treatment for this challenging disease. The goal is to enter the first patient in the last quarter of this year and to complete enrollment of approximately 170 patients over two years."

Dr. Kovach continued, "Doxorubicin alone has been the mainstay of first line treatment of ASTS for over 40 years with little therapeutic gain from adding cytotoxic compounds to or substituting other cytotoxic compounds for doxorubicin. In animal models, LB-100, an inhibitor of protein phosphatase2A (PP2A), consistently enhances the antitumor activity of doxorubicin without apparent increases in toxicity and, in a Phase 1 clinical trial, LB-100 alone was associated with stabilization of an advanced chondrosarcoma and fibrosarcoma for 6 and 9 months, respectively, without toxicity. LB-100 potentiates the effectiveness of agents like doxorubicin by inhibiting multiple steps required to repair chemotherapy induced DNA damage. We are excited to learn if the combination of LB-100 and doxorubicin will finally advance the effectiveness of ASTS therapy."

Dr. Javier Martin-Broto, Coordinating Investigator of the trial and medical oncologist at Virgen del Rocío University Hospital (Seville) commented, "Although there has been an increase in overall survival in advanced sarcoma in recent years, this gain has not been accompanied by advances in first line therapy. Anthracyclines, and specifically doxorubicin, is still the standard initial treatment. The growing list of negative phase III trials indicates to us that sarcoma therapy is in crisis. It is true that sarcoma encompasses more than 60 different subtypes and, for some of them, substantial advances have emerged. But it is also true that the most frequent sarcoma subtypes desperately need a turning point. One promising topic of research is the combination of doxorubicin with drugs that are able to impair the mechanisms of DNA repair. LB-100 has demonstrated synergistic action in in vivo preclinical mesenchymal tumors. GEIS will lead a European initiative to conduct a phase I/randomized II trial exploring the combination of doxorubicin plus LB-100 in first line of advanced soft tissue sarcomas".