On November 5, 2018 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reported that it has been selected to present at the BIO-Europe 24th Annual International Partnering Conference (Press release, Actinium Pharmaceuticals, NOV 5, 2018, View Source [SID1234530708]). The presentation is in addition to the Company’s planned partnering activities at the conference. Sandesh Seth, Actinium’s Chairman and CEO will provide an overview of the Company’s Antibody Radiation Conjugate (ARC) programs including its Iomab-B program and preliminary data from its pivotal Phase 3 SIERRA trial that has been accepted for oral presentation at ASH (Free ASH Whitepaper), its Iomab-ACT program for targeted lymphodepletion prior to CAR-T, its best in class CD33 program and its Antibody Warhead Enabling (AWE) technology platform.

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Presentation Details
Venue: Bella Center Copenhagen
Date: Tuesday, November 6, 2018
Time: 9:00 AM CET
Room: B2 on level 0
Category: Oncology
About BIO-Europe

The 24th annual BIO-Europe is Europe’s largest partnering conference serving the global biotechnology industry. Delegates from all parts of the biotechnology value chain come to BIO-Europe to quickly identify, engage and enter strategic relationships that drive their businesses successfully forward. Investment and collaboration opportunities developed in prior BIO-Europe conferences have produced many highly successful business partnerships. BIO-Europe is organized by EBD Group, the leading partnering firm for the global biotechnology industry, in alliance with the Biotechnology Industry Organization (BIO)

On November 5, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its third quarter 2018 financial results and provided an update on the company and its progress with IPI-549, a first-in-class oral immuno-oncology product candidate that selectively inhibits phosphoinositide-3-kinase-gamma (PI3K-gamma) and targets immuno-suppressive tumor macrophages/myeloid-derived suppressor cells (MDSCs) (Press release, Infinity Pharmaceuticals, NOV 5, 2018, View Source [SID1234530727]).

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"We approach the end of 2018 with tremendous momentum in developing IPI-549 as an effective therapy for patients whose cancers are not adequately treated by existing immuno-therapies," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "Our clinical and translational data have laid the foundation for the broader, later-stage development of IPI-549, including Infinity’s clinical development of IPI-549 in a Phase 2 trial in urothelial cancer in collaboration with Bristol-Myers Squibb. We look forward to providing an update at the SITC (Free SITC Whitepaper) annual meeting on November 10."

Infinity is evaluating IPI-549 as a monotherapy and in combination with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, in collaboration with Bristol-Myers Squibb, in the MARIO-1 Phase 1b study in approximately 200 patients with advanced solid tumors. Infinity is also planning to initiate the MARIO-275 global, randomized Phase 2 study to evaluate the effect of adding IPI-549 to Opdivo in checkpoint inhibitor-naïve advanced urothelial cancer patients who have progressed or recurred following treatment with platinum-based chemotherapy. Approximately 150 patients will be randomized between combination therapy and Opdivo monotherapy. In addition, Arcus Biosciences will initiate two triple combinations investigating IPI-549 with their dual adenosine receptor antagonist, AB928, anti-PD-1 antibody, AB122, and chemotherapy in triple negative breast cancer and ovarian cancer. One triple combination therapy will evaluate IPI-549 in combination with AB928 and AB122 and the second will evaluate IPI-549 in combination with AB928 and chemotherapy, with topline data expected in 2019.

Recent developments include the following:

IPI-549

Infinity to Host Investor Reception and Webcast at the SITC (Free SITC Whitepaper) Annual Meeting to Discuss Combination Expansion Data from the IPI-549 MARIO-1 Phase 1b Study: Saturday, November 10, 2018 from 6:30 a.m. ET – 7:30 a.m. ET.
Announcement of clinical collaboration with BMS to evaluate IPI-549 in MARIO-275 Controlled Phase 2 Study of IPI-549 in Combination with Opdivo in Urothelial Cancer: This study leverages the exploratory analyses of data from Bristol-Myers Squibb’s CheckMate-275 study, in which high levels of MDSCs were associated with shorter overall survival in patients treated with Opdivo.[1] In Infinity’s MARIO-1 trial, MDSCs were reduced in the majority of patients treated with IPI-549 monotherapy.[2] IPI-549 in combination with nivolumab has been well tolerated and demonstrated early evidence of clinical activity with translational studies demonstrating evidence of on-mechanism IPI-549-mediated effects.[3]
Third Quarter 2018 Financial Results

At September 30, 2018, Infinity had total cash, cash equivalents and available-for-sale securities of $42.2 million, compared to $49.2 million at June 30, 2018.
Revenue for the third quarter of 2018 was $22.0 million, all of which related to the amount due from Verastem for the approval by the U.S. Food and Drug Administration on September 24, 2018 of duvelisib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies, as well as adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies. Infinity received the $22.0 million in cash on November 2nd, which is not reflected in the $42.2 million cash balance as of September 30, 2018. Revenue for the third quarter of 2017 was $6.0 million, all of which related to the amount due from Verastem for the DUO study meeting the pre-specified criteria at completion.
R&D expense for the third quarter of 2018 was $5.4 million, compared to $9.3 million for the same period in 2017. The decrease in R&D expense was primarily due to the convertible note issued to Takeda in July 2017.
General and administrative expense was $3.4 million for the third quarter of 2018, compared to $4.5 million for the same period in 2017. The decrease in G&A expense was primarily due to a reduction in stock compensation.
Net income for the third quarter of 2018 was $13.4 million, or a basic and diluted earnings per common share of $0.23, compared to a net loss of $7.1 million, or a basic and diluted loss per common share of $0.14 for the same period in 2017.
Financial Outlook
Infinity’s 2018 financial guidance is:

Net Loss: Infinity expects net loss for 2018 to range from $10 million to $20 million.
Cash and Investments: Infinity expects to end 2018 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $50 million to $60 million.
Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities will be adequate to satisfy the company’s capital needs into 2020. Infinity’s financial guidance excludes additional funding or business development activities and does not include a potential $2 million payment from PellePharm, a private company, upon initiation of a Phase 3 study for the hedgehog inhibitor program, which Infinity licensed to PellePharm in 2013.
Conference Call Information
Infinity will host a conference call today, November 5, 2018, at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) or 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 8617458. An archived version of the webcast will be available on Infinity’s website for 30 days.

About IPI-549 and the Ongoing MARIO-1 Phase 1/1b Study
IPI-549 is an investigational first-in-class, oral, immuno-oncology product candidate targeting tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition, thereby reducing pro-tumor macrophage function and increasing anti-tumor macrophage function. In preclinical studies, IPI-549 demonstrated the ability to reprogram macrophages from a pro-tumor (M2), immune suppressive function, to an anti-tumor (M1) immune activating function and enhance the activity of, and overcome resistance to, checkpoint inhibitors.[4], [5] As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially additive or synergistic approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

The ongoing MARIO-1 Phase 1/1b study being conducted by Infinity is designed to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 200 patients with advanced solid tumors.[6] The study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. The monotherapy dose-escalation and expansion components are complete. The combination dose-escalation component is also complete, and combination expansion cohorts are enrolling.

The combination expansion component of the study includes multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma and head and neck cancer whose tumors show initial resistance or initially respond to but subsequently develop resistance to immune checkpoint blockade therapy. The combination expansion component also includes a cohort of patients with triple negative breast cancer (TNBC) who have not been previously treated with immune checkpoint blockade therapy, a cohort of patients with mesothelioma, a cohort of patients with adrenocortical carcinoma and a cohort of patients with high baseline blood levels of MDSCs.

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On November 5, 2018 Eli Lilly and Company (NYSE: LLY) and NextCure, Inc. reported a multi-year collaboration focused on the discovery and development of immuno-oncology therapies (Press release, Eli Lilly, NOV 5, 2018, View Source [SID1234530744]). The collaboration seeks to discover novel cancer targets utilizing NextCure’s proprietary FIND-IO platform.

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Under the terms of the agreement, Lilly and NextCure will each receive options to exclusively license antibodies resulting from the collaboration. NextCure will receive an upfront payment of $25 million, and will be eligible for development and commercial milestones and royalty payments, should Lilly successfully develop and commercialize new cancer therapies resulting from the collaboration. Additionally, Lilly has made a $15 million equity investment in NextCure.

"The emerging field of immuno-oncology is offering new treatment options and hope to cancer patients," said Greg Plowman, M.D., Ph.D., vice president of oncology research at Lilly. "Through this collaboration, we hope to leverage NextCure’s discovery platform to expand the reach of this class of groundbreaking treatments by identifying novel cancer targets that could enable the development of a new generation of immuno-oncology therapies."

"Partnering with Lilly, a world leader in drug development, to advance the next generation immuno-oncology therapies is important validation of our FIND-IO discovery platform and our approach to discovering and developing immunomedicines," said Michael Richman, NextCure’s president & CEO. "FIND-IO has the potential to identify and rapidly translate immune cell interactions into disease modifying immunomedicines. We look forward to working with Lilly to discover novel targets that will further enhance both companies’ growing immuno-oncology pipelines."

This transaction will be reflected in Lilly’s reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly’s 2018 non-GAAP earnings per share guidance as a result of this transaction.

About FIND-IO
The FIND-IO platform is designed to identify novel cell surface molecular interactions that drive functional immune responses in the tumor microenvironment and other disease sites. NextCure has developed proprietary approaches to assess immune pathways in primary immune cells and established cell lines from immune lineages, including T cells, NK cells, macrophages, myeloid-derived suppressor cells, dendritic cells, as well as cancer cells. NextCure is utilizing FIND-IO technology to identify targets that impact immune function, addressing the major challenge of supplying next generation immunomedicines for patients that do not respond to current cancer therapies.

On November 5, 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported financial results for the third quarter and first nine months of 2018 (Press release, MorphoSys, NOV 5, 2018, View Source [SID1234530766]).

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"The third quarter of 2018 was a productive one for MorphoSys, highlighted by very encouraging progress in therapeutic programs within both our proprietary development and partnered portfolios. Our primary focus is on our lead program MOR208, and here we look forward to releasing latest data from the ongoing L-MIND trial in an oral presentation at the forthcoming ASH (Free ASH Whitepaper) 2018 meeting. This program is proceeding according to plan, and we are committed to completing L-MIND and seeking U.S. approval based on this trial," commented Dr. Simon Moroney, CEO of MorphoSys AG. "Meanwhile, we continue to prepare our commercial organization in the U.S., with the goal of launching MOR208 there, subject, of course, to FDA approval of this investigational drug."

"We are very pleased with MorphoSys’s business performance in 2018 to date. Driven by an attractive licensing deal with Novartis for MOR106 and increasing royalty income from Tremfya(R), we saw strong revenue development in the third quarter. The very good business performance enabled us to increase our financial guidance for the year. Based on a solid cash position, which we further strengthened with our Nasdaq IPO earlier in the year, we are well positioned to continue the advancement of our pipeline products, in particular to drive our lead program MOR208 towards the market," said Jens Holstein, CFO of MorphoSys AG.

Financial review for the third quarter of 2018 (IFRS; all figures rounded)

In Q3 2018, MorphoSys continued to focus on the research and development of drug candidates in its proprietary portfolio, while also supporting the activities of its partners. Group revenues in Q3 2018 amounted to EUR 55.0 million (Q3 2017: EUR 15.0 million). The revenue increase was mainly driven by the up-front payment of EUR 47.5 million for the license agreement for MOR106 with Novartis. As the contractual royalty reporting from Janssen for Q3 2018 has not yet been received due to the reporting schedules of Janssen and MorphoSys, Tremfya(R) royalties booked for Q3 2018 were estimated based on public announcements made by Janssen/J&J on Tremfya(R) sales in Q3 2018.

In the Proprietary Development segment, MorphoSys focuses on the research and clinical development of its own drug candidates in the fields of cancer and inflammation. In Q3 2018, this segment recorded revenues of EUR 48.8 million (Q3 2017: EUR 0.2 million). In the Partnered Discovery segment, MorphoSys applies its proprietary technology to discover new antibodies for pharmaceutical companies, benefiting from its partners’ development advances through R&D funding, licensing fees, success-based milestone payments and royalties. In Q3 2018, revenues in this segment amounted to EUR 6.2 million (Q3 2017: EUR 14.8 million).

Total operating expenses reached EUR 25.3 million in the third quarter of 2018 (Q3 2017: EUR 38.2 million). R&D expenses for proprietary development and technology development amounted to EUR 15.9 million (Q3 2017: EUR 29.8 million).

Earnings before interest and taxes (EBIT) in Q3 2018 amounted to EUR 30.1 million (Q3 2017: EUR -23.5 million), reflecting in particular the up-front payment made by Novartis under the MOR106 license agreement. The Proprietary Development segment reported an EBIT of EUR 30.3 million (Q3 2017: EUR -29.8 million), while the Partnered Discovery segment recorded an EBIT of EUR 3.8 million (Q3 2017: EUR 10.4 million). In Q3 2018, the consolidated net result amounted to EUR 30.2 million (Q3 2017: EUR -24.0 million). Basic earnings per share for Q3 2018 reached EUR 0.96 (Q3 2017: EUR -0.83).

At the end of Q3 2018, the Company had a cash position of EUR 481.2 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 in conjunction with the successful Nasdaq listing completed in April 2018 with gross proceeds of USD 239 million and the upfront payment made by Novartis in the third quarter 2018 in the amount of EUR 47.5 million in connection with the license agreement for MOR106. This was partially offset by the use of cash for operating activities.

The number of shares issued totaled 31,839,572 at the end of Q3 2018 (year-end 2017: 29,420,785). The increase was mainly driven by the capital increase in April 2018.

Results for the first nine months 2018

For the first nine months of 2018, group revenues amounted to EUR 66.0 million (Q1-Q3 2017: EUR 38.6 million). Expenditure for proprietary development and technology development amounted to EUR 55.1 million in the first nine months of 2018 (Q1-Q3 2017: EUR 67.1 million). Consequently, EBIT in the first nine months of 2018 amounted to EUR -13.0 million, compared to EUR -53.8 million in the first nine months of 2017.

Financial guidance and operational outlook for 2018

MorphoSys confirms its 2018 financial guidance which had been increased after signing an agreement with Novartis for MOR106 in July 2018. In the light of the recent positive development of Tremfya(R) royalties, MorphoSys expects revenues on the upper end of the guided range from EUR 67 million to EUR 72 million for 2018. Earnings before interest and taxes (EBIT) are expected to be EUR -55 million to EUR -65 million. R&D expenses for proprietary programs and technology development are expected to be in a range of EUR 87 million to EUR 97 million. This guidance does not include additional revenues from potential future collaborations and/or license agreements nor any effects from possible in-licensing or development partnerships for new drug candidates.

MorphoSys expects the following events and activities in the Proprietary Development segment during the remainder of the year:

MOR208

– L-MIND:

– Continue discussions with the FDA to evaluate possible paths to market, including the possibility of an expedited regulatory submission and potential approval based primarily on the L-MIND study.

– Presentation of updated interim results on all 81 patients enrolled in the study evaluating MOR208 plus lenalidomide in r/r DLBCL at the ASH (Free ASH Whitepaper) (American Society of Hematology) 2018 Annual Meeting, which will be held in San Diego, California, in early December.

– B-MIND: Continue the enrollment in the phase 3 part of the 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 chronic lymphocytic leukemia (CLL/SLL) and present data from cohort B (MOR208 plus venetoclax) at the upcoming ASH (Free ASH Whitepaper) 2018 Annual Meeting.

– Commercial and CMC activities: Secure commercial supply of MOR208 and continue to build commercial capabilities for MOR208 in the U.S. under the newly established MorphoSys US Inc., in preparation for a potential market launch, currently anticipated in 2020 pending FDA approval.

MOR202

– Multiple myeloma (MM): Study results from the ongoing phase 1/2a study will also be presented at the upcoming ASH (Free ASH Whitepaper) 2018 Annual Meeting. As previously communicated, MorphoSys will not continue development in MM beyond completion of the current trial without an additional partner for Ex-China; MorphoSys expects its partner I-Mab Biopharma to continue preparations for clinical development in MM and to start a pivotal trial in early 2019 in China.

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

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

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

– Continue the phase 1 bridging study initiated in September 2018 to evaluate a subcutaneous formulation of MOR106.

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

MOR107: Continue preclinical investigations of MOR107 with a focus on oncology indications.

MOR103/GSK3196165: Following presentation of data from several phase 2 trials in inflammatory diseases including rheumatoid arthritis (RA) run by partner GlaxoSmithKline (GSK) at the American College of Rheumatology (ACR) meeting in October 2018, MorphoSys expects GSK to further continue clinical development activities in RA.

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

Tremfya(R) (guselkumab): Several phase 3 trials in psoriasis are scheduled for primary completion in 2018 according to clinicaltrials.gov. This includes a head-to-head trial comparing Tremfya(R) to Cosentyx(R) in adults with plaque psoriasis, results of which are expected to be communicated in early 2019. MorphoSys expects Janssen to continue its current development program with Tremfya(R) including two phase 3 trials in psoriatic arthritis, the phase 2/3 GALAXI program in Crohn’s disease as well as the clinical phase 3 PROTOSTAR trial in pediatric psoriasis patients.

Other partnered programs: The publication of clinical data and the achievement of regulatory milestones from other partnered programs may occur during the remainder of 2018.

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

** 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, and MOR106, for which MorphoSys and Galapagos have signed a global licensing agreement with Novartis.

The interim statement for the third quarter of 2018 (IFRS) is available online:

View Source

MorphoSys will hold a conference call and webcast on November 6, 2018, to present the third quarter 2018 financial results and provide an outlook for the remainder of 2018.

Dial-in number for the analyst conference call (in English) at 2:00pm CET; 1:00pm GMT; 8:00am EST (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: 79499880#

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

On November 5, 2018 Flex Pharma, Inc. (NASDAQ: FLKS), reported its financial results for the three months ended September 30, 2018 (Press release, Flex Pharma, NOV 5, 2018, View Source [SID1234532475]).

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On June 13, 2018, the Company announced that it was ending its ongoing Phase 2 clinical trial investigations of FLX-787 in Motor Neuron Disease (MND), which primarily included patients with amyotrophic lateral sclerosis (ALS), and in Charcot-Marie-Tooth disease (CMT), was reducing its workforce and engaged Wedbush PacGrow to help the Company assess its strategic alternatives.

"During the third quarter, we continued our assessment of strategic alternatives for the Company. While that assessment is underway, we are working diligently to conserve working capital and enhance stockholder value. We plan to announce additional information once our assessment is complete," stated Bill McVicar, Ph.D., President and CEO of Flex Pharma.

Corporate Activities:

The Company has stopped its clinical trials in MND and CMT and the wind-down of the associated activities was completed in the third quarter of 2018.

The reduction in the Company’s workforce announced on June 13, 2018 was completed by September 30, 2018.
Third Quarter 2018 Financial Results

Cash Position: As of September 30, 2018, Flex Pharma had cash and cash equivalents of $13.0 million. The Company held no marketable securities at September 30, 2018. During the three months ended September 30, 2018, cash and cash equivalents decreased by $2.8 million.

Total Revenue: Total HOTSHOT revenue for the three months ended September 30, 2018 was approximately $251,000.

Cost of Product Revenue: Cost of product revenue for the three months ended September 30, 2018 was approximately $92,000. There were no inventory write-offs during the three months ended September 30, 2018.
R&D Expense: Research and development expense for the three months ended September 30, 2018 was $0.9 million. Research and development expense for this period primarily included costs associated with the Company’s clinical operations and wind-down of FLX-787 Phase 2 clinical studies, personnel costs (including salaries, termination-related costs, retention-related costs and stock-based compensation costs) and external consultant costs.
SG&A Expense: Selling, general and administrative expense for the three months ended September 30, 2018 was $2.0 million. Selling, general and administrative expense for this period primarily included personnel costs (including salaries, retention-related costs and stock-based compensation costs), fulfillment costs related to HOTSHOT, legal and professional costs, and external consultant costs.

Net Loss and Cash Flow: Net loss for the three months ended September 30, 2018 was ($2.6) million, or ($0.15) per share and included $0.3 million of stock-based compensation expense. As of September 30, 2018, Flex Pharma had 18,066,767 shares of common stock outstanding. The net loss for the third quarter of 2018 was primarily driven by the Company’s operating expenses related to its research and development efforts, costs associated with HOTSHOT, and general and administrative costs.