On April 1, 2018 MorphoSys AG Reported Second Quarter 2018 Financial Results (Press release, MorphoSys, AUG 1, 2018, View Source [SID1234528367])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The Company has further advanced its pipeline, including proprietary and partnered programs, and established a U.S. footprint to prepare for commercialization in the U.S.

Conference call and webcast (in English) to be held on August 2, 2018, at 2:00 pm CEST (1:00 pm BST / 8:00 am EDT)

– Ongoing discussions with U.S. FDA regarding path to market for MOR208 as potential therapy for aggressive lymphoma (DLBCL) under the existing breakthrough therapy designation

– First clinical data from ongoing phase 2 trial of MOR208 plus idelalisib in CLL presented at European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting

– Jennifer Herron to head newly founded MorphoSys US Inc. and build commercial capabilities for MOR208

– MorphoSys and Galapagos entered into a global license agreement with Novartis for MOR106. MorphoSys and Galapagos to jointly receive up-front payment of EUR 95 million as well as significant potential future milestone payments plus double-digit royalties

– Partner Janssen initiated pivotal phase 2/3 program of Tremfya(R) in Crohn’s disease

– First patient dosed in phase 3 trial conducted by Roche with gantenerumab as a potential therapy for early Alzheimer’s disease

– U.S. Nasdaq listing and successful capital increase with gross proceeds of USD 239 million completed in April 2018

– Cash position increased to EUR 450.5 million as of June 30, 2018

– Following the signature of a deal with Novartis for MOR106 in July 2018 and subject to U.S. antitrust clearance, MorphoSys is increasing its financial guidance for 2018, expecting revenues of between EUR 67 and 72 million, EBIT of EUR -55 to -65 million, and expenses for proprietary development and technology development of EUR 87 to 97 million

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; NASDAQ: MOR) today reported financial results for the second quarter of 2018.

"MorphoSys has made excellent progress on a number of fronts during the quarter. We continued our constructive discussions with the FDA regarding a path to market for MOR208 in aggressive lymphoma (DLBCL) and presented positive data from our ongoing phase 2 trial of MOR208 in chronic lymphocytic lymphoma (CLL)," commented Dr. Simon Moroney, CEO of MorphoSys AG. "With the establishment of our new U.S. subsidiary MorphoSys US Inc. and the appointment of Jennifer Herron as the head of this organization, we have laid the foundation for a strong commercial presence in preparation for the potential future commercialization of MOR208, subject of course to FDA approval of this investigational drug."

"We are also very pleased with the advances made by our partners, notably the continued successful marketing of Tremfya(R) in psoriasis by Janssen as well as the start of additional pivotal programs with Tremfya(R) in Crohn’s disease by Janssen and with gantenerumab in Alzheimer’s disease by Roche," Dr. Moroney continued.

"This has been an exciting quarter at MorphoSys and we are encouraged by the recent corporate developments. We successfully listed at Nasdaq in April and, shortly after the quarter, signed an exclusive licensing deal with Novartis for MOR106," said Jens Holstein, CFO of MorphoSys AG. "Our strong financial position provides us with the flexibility to allocate the necessary resources to our lead program MOR208, continue the advancement of our other pipeline programs and build out our U.S. commercial operations."

Financial Review for the second quarter of 2018 (IFRS; all figures rounded)

In Q2 2018 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 amounted to EUR 8.1 million in Q2 2018 (Q2 2017: EUR 11.7 million). The expected decline compared to the previous year’s second quarter resulted mainly from the completion of a partnership with Novartis in 2017. As the contractual royalty reporting from Janssen for Q2 2018 has not yet been received due to the reporting schedules of Janssen and MorphoSys, Tremfya(R) royalties booked for Q2 2018 were estimated based on public announcements made by Janssen/J&J on Tremfya(R) sales in Q2 2018.

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 2018, this segment recorded revenues of EUR 0.1 million (Q2 2017: EUR 0.3 million). In the Partnered Discovery segment, MorphoSys applies its proprietary technology to discover new antibodies for pharmaceutical companies, benefiting from its partners’ development advancements through R&D funding, licensing fees, success-based milestone payments and royalties. In Q2 2018, revenues in this segment amounted to EUR 8.1 million (Q2 2017: EUR 11.5 million).

Total operating expenses reached EUR 32.7 million in the second quarter of 2018 (Q2 2017: EUR 27.5 million). Proprietary development expenses and technology development expenses amounted to EUR 24.7 million (Q2 2017: EUR 18.6 million). The increase over the previous year’s quarter is mainly due to costs to advance the development of MOR208.

Earnings before interest and taxes (EBIT) in Q2 2018 amounted to EUR -24.1 million (Q2 2017: EUR -15.4 million). The Proprietary Development segment reported an EBIT of EUR -24.6 million (Q2 2017: EUR -18.3 million). EBIT in the Partnered Discovery segment was EUR 5.5 million (Q2 2017: EUR 6.8 million). In Q2 2018, the consolidated net result amounted to EUR -23.5 million (Q2 2017: EUR -16.1 million). The earnings per share for Q2 2018 reached EUR -0.76 (Q2 2017: EUR -0.56).

At the end of Q2 2018, the Company had a cash position of EUR 450.5 million, compared to EUR 312.2 million on December 31, 2017. On the balance sheet, this cash position is reported under the following 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. The increase in funds resulted mainly from the capital increase together with the successful Nasdaq listing completed in April with gross proceeds of USD 239 million. This was partially offset by the use of cash for operating activities in the second quarter of 2018. This cash position does not include the upfront payment to be made by Novartis in connection with the license agreement for MOR106, subject to U.S. antitrust clearance, that was signed after the end of the reporting period.

The number of shares issued totaled 31,808,035 at the end of Q2 2018 (year-end 2017: 29,420,785). The main reason for the increase in the number of shares was the capital increase in connection with the Nasdaq listing in April 2018.

Results for the first six months 2018

During the first six months of 2018, group revenues amounted to EUR 10.9 million (Q1-Q2 2017: EUR 23.6 million). Expenditure for proprietary development and technology development amounted to EUR 39.2 million in the first six months of 2018 (Q1-Q2 2017: EUR 37.3 million). Consequently the EBIT in the first six months of 2018 amounted to EUR -43.2 million, compared to EUR -30.3 million in the first half of 2017.

Financial Guidance and Operational Outlook for 2018

Following the recent signature of a deal with Novartis on MOR106 and pending U.S. antitrust clearance, MorphoSys is increasing its financial guidance for 2018. Subject to U.S. antitrust clearance, MorphoSys expects Group revenues in the range of EUR 67 to 72 million and earnings before interest and taxes (EBIT) of EUR -55 to -65 million. Expenses for proprietary development and technology development are expected to be in a corridor of EUR 87 to 97 million. This guidance does not include any additional revenue from potential new collaborations and/or licensing partnerships nor effects from potential in-licensing or co-development deals for new development candidates.

MorphoSys expects the following events and activities in the Proprietary Development segment for 2018:

MOR208

– L-MIND: Continue analysis of maturing data of all 81 patients with relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL) enrolled in the trial and present updated clinical data at an appropriate medical conference.

– B-MIND: Continue the pivotal phase 3 study evaluating MOR208 plus bendamustine versus rituximab plus bendamustine in r/r DLBCL.

– COSMOS: Continue the phase 2 trial of MOR208 plus idelalisib or venetoclax in CLL/SLL and present data from cohort B (MOR208 plus venetoclax) at an appropriate medical conference.

– Commercial activities: Continue establishment of commercial capabilities for MOR208 in the U.S. under the roof of the newly established MorphoSys US Inc., in preparation for a potential launch currently anticipated in 2020 pending FDA approval.

MOR202

– Multiple myeloma (MM): MorphoSys has decided not to continue development of MOR202 in MM beyond completion of the currently ongoing phase 1/2a trial; final data are expected to be presented at an upcoming medical conference. MorphoSys will continue to support its partner I-Mab’s development of MOR202 for the greater Chinese market as planned.

– Lung cancer (NSCLC): Following the discontinuation of a clinical study by Janssen of the CD38 antibody daratumumab in combination with a checkpoint inhibitor, MorphoSys has decided not to continue activities in NSCLC for the time being

– Other indications: MorphoSys continues to evaluate the development of MOR202 in other indications.

MOR106: Continue the ongoing development together with partner Galapagos under the new global licensing agreement with Novartis.

– Continue the ongoing phase 2 IGUANA trial in atopic dermatitis.

– Initiate phase 1 study to evaluate a subcutaneous formulation of MOR106.

– All future costs related to MOR106 development to be borne by Novartis.

– Agreement between MorphoSys, Galapagos, and Novartis is subject to clearance by the U.S. antitrust authorities.

MOR107: Continue preclinical investigations of MOR107 with a focus on oncology indications to inform a decision regarding potential further clinical testing.

MOR103/GSK3196165: Following GSK’s recent announcement that positive phase 2b results in rheumatoid arthritis are to be presented at a future scientific congress and that the osteoarthritis indication has been terminated, the publication of clinical data by GSK is expected.

In its Partnered Discovery segment, MorphoSys expects the following events in 2018:

Tremfya(R) (guselkumab): Several phase 3 trials in psoriasis are scheduled for primary completion in 2018 according to clinicaltrials.gov, including a head-to-head trial comparing Tremfya(R) to Cosentyx(R) (secukinumab) in plaque psoriasis.

Other partnered programs: Clinical data and potential regulatory milestones from a number of other partnered programs to be potentially published during the year.

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.

Percentage points
** 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.
*** Including MOR103/GSK3196165 which is fully out-licensed to GSK.

MorphoSys will hold its conference call and webcast on August 2, 2018 to present the second quarter 2018 financial results and the further outlook for 2018.

Dial-in number for the analyst conference call (in English) at 2:00 pm CEST; 1:00 pm BST; 8:00 am EDT (listen-only):
Germany: +49 (0) 69 201 744 210
For UK residents: +44 (0) 203 009 2470
For US residents: +1 (0) 877 423 0830

Participant PIN: 63419794#

Participants are asked to dial in 10 minutes before the beginning of the conference. A live webcast and slides will be made available at View Source After the conference call, a slide-synchronized audio replay of the conference and a transcript will be available at View Source

The interim statement for the second quarter of 2018 (IFRS) is available online:
View Source

On August 1, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported financial results for the second quarter ended June 30, 2018 (Press release, Aduro Biotech, AUG 1, 2018, View Source;p=RssLanding&cat=news&id=2361412 [SID1234528388]). Net loss for the second quarter of 2018 was $24.4 million, or $0.31 per share, and for the six months ended June 30, 2018 net loss was $45.9 million, or $0.59 per share, compared to net loss of $19.4 million, or $0.27 per share, and net loss of $41.2 million, or $0.59 per share, respectively, for the same periods in 2017.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Recent Developments:

Presented updated preclinical data for ADU-S100, a first-in-class small molecule therapeutic in Phase 1 studies targeting the STING pathway at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) held on April 14-18, 2018
Presented at AACR (Free AACR Whitepaper) preclinical data for BION-1301, an anti-APRIL antibody currently in a Phase 1/2 study for the treatment of patients with multiple myeloma
Presented at AACR (Free AACR Whitepaper) preclinical data for ADU-1604, an anti-CTLA-4 antibody scheduled to enter clinical development in the second half of 2018
Presented preliminary observations from case study of a patient with metastatic colorectal cancer treated in ongoing proof-of-concept Phase 1 trial of personalized neoantigen-based immunotherapy (pLADD) program at the European Neoantigen Summit held on April 24-26, 2018
Announced initiation of Phase 1b study of ADU- 214 in combination with nivolumab for the treatment of advanced lung cancer under strategic partnership with Janssen
Cash, cash equivalents and marketable securities totaled $305.9 million at June 30, 2018, compared to $349.7 million at December 31, 2017.

Revenue was $2.6 million for the second quarter of 2018 and $9.3 million for the six months ended June 30, 2018, compared to $5.9 million and $9.7 million, respectively, for the same periods in 2017. The variation in collaboration and license revenue for the quarter was primarily due to the timing of milestone payments earned from Merck for advancement of its anti-CD27 antibody, which entered clinical development in early 2018. The decrease in revenue for the first half of 2018 was primarily due to the adoption of the ASC 606 accounting standard on January 1, 2018, which resulted in a change in revenue recognition methodology for our Novartis collaboration revenue.

Research and development expenses were $19.4 million for the second quarter of 2018 and $39.5 million for the six months ended June 30, 2018, compared to $21.4 million and $42.0 million, respectively, for the same periods in 2017. The decrease in research and development expenses for both periods was primarily due to lower expenses for our antibody programs, including contingent consideration and contract manufacturing related to ADU-1604 and BION-1301, respectively. In addition, clinical development expenses declined in 2018 following the wind down of CRS-207 development activities, partially offset by increased expenses for our ongoing clinical programs including ADU-S100, BION-1301, ADU-1604 and our personalized neoantigen-based immunotherapy.

General and administrative expenses were $8.8 million for the second quarter of 2018 and $17.9 million for the six months ended June 30, 2018, compared to $8.2 million and $16.5 million, respectively, for the same periods in 2017. The increase in general and administrative expenses for both periods was primarily due to outside professional services, legal fees associated with our patent portfolio and higher stock-based compensation expense.

On August 1, 2018 Ophthotech Corporation (Nasdaq:OPHT) reported financial and operating results for the second quarter ended June 30, 2018 and provided a business update (Press release, Ophthotech, AUG 1, 2018, View Source [SID1234528287]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"During the first half of the year, we continued implementing our strategy to broaden and advance our ophthalmic portfolio as we enter the emerging field of gene therapy by securing collaborations with three leading academic institutions, and continued advancing our therapeutic portfolio with Zimura," stated Glenn P. Sblendorio, Chief Executive Officer and President of Ophthotech. "Looking ahead to the remainder of 2018, we expect to report data for our Phase 2a clinical trial for Zimura combination therapy with anti-VEGF in wet-age related macular degeneration (AMD), complete recruitment for our Phase 2b clinical trial for Zimura monotherapy in geographic atrophy secondary to dry AMD and potentially enter into new opportunities to further expand our portfolio in both therapeutics and gene therapies for retinal diseases."

First Half 2018: Key Highlights

Zimura Complement Factor C5 Inhibitor Program

In April 2018, the Company completed patient recruitment in its randomized, dose-ranging, open-label, uncontrolled, multi-center Phase 2a clinical trial of Zimura (avacincaptad pegol) in combination with the anti-vascular endothelial growth factor (anti-VEGF) agent Lucentis (ranibizumab) in patients with wet age-related macular degeneration (AMD) who have not been previously treated with anti-VEGF therapies. This trial is designed to assess the safety of Zimura combination therapy at different dosages and to detect a potential efficacy signal. Data will be evaluated at month six and initial top-line data is expected to be available by the end of 2018.
Patient recruitment for the Company’s ongoing randomized, double-masked, sham controlled, multi-center Phase 2b clinical trial of Zimura for the treatment of geographic atrophy secondary to dry AMD is on track. The Company expects to complete recruitment in the third quarter of this year with initial top-line data expected to be available during the second half of 2019.
In January 2018, the Company started enrolling patients in a Phase 2b randomized, double-masked, sham-controlled, multi-center clinical trial assessing the efficacy and safety of Zimura in patients with autosomal recessive Stargardt disease (STGD1). Initial top-line data is expected to be available in 2020.
Gene Therapy Programs

The Company has initiated an innovative gene therapy program focused on applying novel gene therapy technology to discover and develop new therapies for ocular diseases.
In June 2018, the Company entered into an exclusive global license agreement with the University of Florida Research Foundation, Incorporated and the Trustees of the University of Pennsylvania (Penn) for rights to develop and commercialize a novel adeno-associated virus gene therapy product candidate for the treatment of rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP), an orphan monogenic disease. The construct for the RHO-adRP product candidate combines a transgene expressing a highly efficient novel short hairpin RNA (shRNA) designed to target and knock-down endogenous rhodopsin (RHO) in a mutation-independent manner with a human RHO replacement transgene made resistant to RNA interference, in a single adeno-associated viral (AAV 2/5) vector. Ophthotech and Penn have also entered into a master sponsored research agreement, facilitated by the Penn Center for Innovation, pursuant to which Ophthotech and Penn plan to conduct natural history studies in RHO-adRP patients and additional preclinical studies. In parallel with the sponsored research, Ophthotech plans to commence IND-enabling activities. Based on current timelines and subject to regulatory review, Ophthotech expects to initiate a Phase 1/2 clinical trial in RHO-adRP in 2020.
In February 2018, the Company entered into a series of sponsored research agreements with the University of Massachusetts Medical School (UMMS) and its Horae Gene Therapy Center to utilize their next generation "minigene" therapy approach for the potential treatment of orphan degenerative retinal diseases such as Leber Congenital Amaurosis (LCA) type 10 due to CEP290 mutations (the most common type of LCA), and autosomal recessive Stargardt disease (STGD1) due to ABCA4 mutations. Further, the Company and UMMS are also evaluating novel gene delivery methods to target retinal diseases. UMMS has granted Ophthotech an option to obtain an exclusive license to any patent or patent applications that result from this research.
2018 Operational Update

As of June 30, 2018, the Company had $146 million in cash and cash equivalents. The Company estimates that its year end 2018 cash and cash equivalents will range between $112 million and $117 million based on its current 2018 business plan and planned capital expenditures. This estimate includes continuation of the Company’s development programs for Zimura and RHO-adRP gene therapy product candidate and the continuation of the Company’s collaborative gene therapy research programs as currently planned.

This estimate does not reflect any additional expenditures resulting from the potential in-licensing or acquisition of additional product candidates or technologies or associated development that the Company may pursue.

2018 Financial Highlights

Revenues: The Company did not have any collaboration revenue for the quarter and six months ended June 30, 2018, compared to $1.7 million and $3.3 million for the same periods in 2017. Collaboration revenue decreased due to the completion of the Company’s deliverables under its previous licensing and commercialization agreement with Novartis Pharma AG and the recognition of all associated deferred revenue during the third quarter of 2017.
R&D Expenses: Research and development expenses were $8.5 million for the quarter ended June 30, 2018, compared to $15.7 million for the same period in 2017. For the six months ended June 30, 2018, research and development expenses were $16.2 million compared to $47.6 million for 2017. As the Company pursues its ongoing and planned Zimura and gene therapy development programs, research and development expenses decreased primarily due to decreases in expenses related to the discontinuation of the Company’s FovistaPhase 3 clinical program and decreases in costs associated with the Company’s 2017 reduction in personnel program.
G&A Expenses: General and administrative expenses were $6.3 million for the quarter ended June 30, 2018, compared to $8.6 million for the same period in 2017. For the six months ended June 30, 2018, general and administrative expenses were $12.0 million compared to $21.7 million for 2017. General and administrative expenses decreased primarily due to decreases in costs to support the Company’s operations and infrastructure and decreases in costs associated with its 2017 reduction in personnel program, which includes facilities lease termination expenses incurred during the first quarter of 2017.
Net Loss: The Company reported a net loss for the quarter ended June 30, 2018 of $13.2 million, or ($0.37) per diluted share, compared to a net loss of $22.2 million, or ($0.62) per diluted share, for the same period in 2017. For the six months ended June 30, 2018, the Company reported a net loss of $26.3 million, or ($0.73) per diluted share, compared to a net loss of $65.3 million, or ($1.82) per diluted share, for the same period in 2017.
Conference Call/Web Cast Information

Ophthotech will host a conference call/webcast to discuss the Company’s financial and operating results and provide a business update. The call is scheduled for August 1, 2018 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 800-458-4121 (USA) or 323-794-2597 (International), passcode 3698278. A live, listen-only audio webcast of the conference call can be accessed on the Investor Relations section of the Ophthotech website at: www.ophthotech.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA Toll Free), passcode 3698278.

On August 1, 2018 AVEO Oncology (NASDAQ: AVEO) reported that Michael Bailey, president and chief executive officer, will present at the Canaccord Genuity 38th Annual Growth Conference in Boston on Wednesday, August 8, 2018 at 4:30 p.m. Eastern Time (Press release, AVEO, AUG 1, 2018, View Source;p=RssLanding&cat=news&id=2361232 [SID1234528350]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation can be accessed by visiting the investors section of the Company’s website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

On August 1, 2018 Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, reported its participation in the following upcoming investor conferences (Press release, Blueprint Medicines, AUG 1, 2018, View Source;p=RssLanding&cat=news&id=2361416 [SID1234528389]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

38th Annual Canaccord Genuity Growth Conference in Boston, MA on Wednesday, August 8, 2018 at 3:00 p.m. E.T.

2018 Wedbush PacGrow Healthcare Conference in New York, NY on Wednesday, August 15, 2018 at 9:10 am. E.T.

A live webcast of each presentation will be available by visiting the Investors section of Blueprint Medicines’ website at View Source A replay of the webcast will be archived on Blueprint Medicines’ website for 30 days following each presentation.