On May 15, 2019 The SanBio Group (SanBio Co., Ltd. and SanBio, Inc.)(TOKYO:4592), a scientific leader in regenerative medicine for neurological disorders, reported the appointment of Bijan Nejadnik, M.D., as its new Chief Medical Officer in charge of development and regulatory affairs (Press release, Sanbio, MAY 15, 2019, View Source [SID1234536348]).

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Dr. Nejadnik has held many important positions, including key roles at Johnson & Johnson Services, Inc., a major pharmaceutical company, as well as pioneering clinical programs in the pharmaceutical and biotech industry, such as Jazz Pharmaceuticals, Inc., Galena Biopharma, Inc., and Eureka Therapeutics, Inc. At Johnson & Johnson, he was involved in the development of immunological and oncology therapeutics, including the development of infliximab (trade name: Remicade) used for the treatment of rheumatic and other autoimmune disorders. At Jazz Pharmaceuticals, he submitted Biologics License Applications (BLA) for multiple oncology therapeutics and obtained approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). As Chief Medical Officer at Galena Biopharma, he led the research of immunotherapy for multiple cancers and research in adoptive T-cell therapy in combination with checkpoint inhibitor drugs. As Chief Medical Officer at Eureka Therapeutics, he was involved in the development of genetically modified T-cells and obtained FDA approval for several IND and launched the clinical trials. Dr. Nejadnik thus is a leading figure in clinical development, with diverse experience.

In Japan, using the conditional and term-limited authorization system for regenerative medicine products under the Revised Pharmaceutical Affairs Act, the SanBio Group is currently working toward applying for manufacturing and marketing approval of SB623 for the treatment of chronic motor deficit resulting from traumatic brain injury (TBI) during the fiscal year ending January 31, 2020 (February 1, 2019–January 31, 2020). Further, it plans to initiate a Phase 3 clinical trial of SB623 for the same indication by the end of the fiscal year ending January 31, 2020. Dr. Nejadnik will work on leading these clinical developments for obtaining approval, and in the long term, will work to promote global expansion of the Group.

Damien Bates, M.D., PhD, FRACS, MBA, who until today has served as the Group’s Chief Medical Officer and Head of Research, will continue to contribute to the global development of the regenerative cell medicine SB623 as the Group’s senior advisor.

Accepting the position of Chief Medical Officer, Dr. Nejadnik commented, "I have been involved in the development of many new pharmaceutical drugs with a view to meeting unmet medical needs that lack effective treatment. SanBio is a pioneer in drug development for patients suffering central nervous system disorders. I understand that the development of SB623 has already come close to the stage of product launch in Japan; taking advantage of my past experiences, I will do my best to bring SB623 to patients worldwide as soon as possible."

"I am very pleased to welcome Dr. Bijan Nejadnik as SanBio’s new Chief Medical Officer," said Keita Mori, CEO of SanBio, Co., Ltd. "In Japan, the development program for SB623 as a treatment for chronic motor deficit resulting from TBI has already advanced to a stage that we are preparing for obtaining the approval for launch under the conditional and term-limited authorization system for regenerative medicine products. Going forward, we aim to bring the product to the global market. We expect that Dr. Nejadnik will receive the baton from Dr. Damien Bates and, by drawing on his extensive experience, will make further contributions to the clinical development and submission process towards the approval of SB623."

On May 15, 2019 Mateon Therapeutics, Inc. (OTCQB:MATN), a biopharmaceutical company developing investigational drugs for the treatment of orphan oncology indications, reported financial results for the first quarter of 2019 (Press release, Mateon Therapeutics, MAY 15, 2019, View Source [SID1234536347]).

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For the three months ended March 31, 2019, Mateon reported a net loss of $0.6 million, compared to a net loss of $0.8 million for the three months ended March 31, 2018. As of March 31, 2019, Mateon had cash of $0.2 million. On April 22, 2019, Mateon merged with Oncotelic, Inc., a clinical-stage cancer immunotherapy company focused on TGF-β RNA therapeutics. Because the first quarter of 2019 ended prior to the date of the merger, the financial results reported today do not include any financial results for Oncotelic.

"I am excited about the growth potential for our newly combined company – we have a promising pipeline of next-generation immunotherapies targeting several significant cancer markets where there are significant unmet medical needs," said Vuong Trieu, Ph.D., Chairman and Chief Executive Officer of Mateon and co-founder of Oncotelic. "Earlier this month, we presented two posters on our proprietary self-immunization protocol at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These posters showed OT-101’s ability to reactivate immune cells directly around the cancer tissue. Our goal is to advance this candidate in the clinic and have an approvable anti-cancer drug within a few years."

About OT-101
The company’s lead product candidate, OT-101, is being developed as a broad-spectrum anti-cancer drug that can also be used in combination with other standard cancer therapies to establish an effective multi-modality treatment strategy for difficult-to-treat cancers, including high-grade gliomas and pancreatic cancer. The company plans to initiate phase 3 clinical trials for OT-101 in both high-grade glioma and pancreatic cancer. During phase 2 clinical trials in pancreatic cancer, melanoma, and colorectal cancers (Study P001) and high-grade gliomas (Study G004), meaningful clinical benefits were observed and OT-101 exhibited a favorable safety profile. These clinical benefits included long term survival and meaningful tumor reduction. Both partial and complete responses have been observed in the G004 Phase 2 clinical trial of OT-101 as a single agent in patients with aggressive brain tumors and in patients with treatment failure pancreatic cancers.

About the company’s Self-Immunization Protocol (SIP©)
The company’s self-immunization protocol (SIP©) is based on novel and proprietary sequential treatment of cancers with OT-101 (an antisense against TGF-β2) and chemotherapies. This sequential treatment strategy is aimed at achieving effective self-immunization against a patients’ own cancer, resulting in robust therapeutic immune response and consequently better control of the cancer and improved survival. Prolonged states of being cancer-free have been observed in some patients with the most aggressive forms of cancer, raising a renewed hope for a potential cure. The use of OT-101 lifts the suppression of the patient’s immune cells around the cancer tissue, providing the foundation for an effective initial priming, which is critical for a successful immune response. The subsequent chemotherapy results in the release of neoantigens that result in a robust boost of the immune response. The company believes that a rational combination of the Oncotelic SIP platform with immune-modulatory drugs like interleukin 2 (IL-2) and/or immune checkpoint inhibitors has the potential to help achieve sustained and robust immune responses in patients with the most difficult-to-treat forms of cancer.

The mechanism of action of SIP© presentations at the AACR (Free AACR Whitepaper) Annual Meeting are now available for viewing at www.oncotelic.com:

Abstract Number: 3968 / 24: OT-101/Chemotherapy – A novel mechanism of action (MOA) in pancreatic cancer immunization therapy.
Abstract Number: 5029 / 23: OT-101/Chemotherapy – A novel mechanism of action (MOA) in gliomas immunization therapy.

On May 15, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that management will present at the RBC Capital Markets 2019 Global Healthcare Conference on Wednesday, May 22, 2019 at 8:30 a.m. Eastern Time (Press release, Seattle Genetics, MAY 15, 2019, View Source [SID1234536346]). The presentation will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.

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On May 15, 2019 Omeros Corporation (NASDAQ: OMER) reported that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the UBS Global Healthcare Conference in New York next week (Press release, Omeros, MAY 15, 2019, View Source [SID1234536345]). The presentation is scheduled for Wednesday, May 22, 2019 at 8:00 a.m. EDT.

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The presentation will be webcast. The live and archived webcasts can be accessed on the investor relations page of company’s website at www.omeros.com.

On May 15, 2019 AC Immune SA (NASDAQ: ACIU), a Swiss-based, biopharmaceutical company with a broad clinical-stage pipeline focused on pioneering Precision Medicine in neurodegenerative diseases, reported financial results for the first quarter ended March 31, 2019 (Press release, AC Immune, MAY 15, 2019, View Source [SID1234536344]).

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Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune, commented: "Our CHF 300 million cash position, funds operations through Q3 2023, allowing us to achieve multiple potentially transformative goals. This is thanks to SupraAntigen and Morphomer, our proprietary discovery platforms, which already have generated multiple clinical and preclinical product-candidates and about CHF 300 million in partnering revenues for rights to our industry-leading therapeutic candidates to treat neurodegenerative diseases. We expect multiple developments in 2019, including initiation of a Phase 1 trial of small molecule Tau Morphomer, as we advance our new partnership with Eli Lilly, and the interim Phase 1b data on ACI-24 to treat Alzheimer’s disease (AD) in Down syndrome."

"Our key near- to medium-term focus is on developing our Tau therapies to treat early and moderate AD based on the growing body of clinical evidence that Tau pathology drives disease progression," added Dr Pfeifer. "As the key opinion leaders have advised, we also are continuing testing of Abeta therapeutics, like ACI-24 and crenezumab, in carefully selected more homogeneous populations for early treatment and prevention, such as AD in Down syndrome patients and familial AD, respectively. The Roadmap to successful therapies for neurodegenerative diseases like Alzheimer’s requires that we treat earlier in the course of disease and select more homogenous populations using Precision Medicine and, as soon as practical, combination therapies."

Financial Highlights Q1 2019

Enhanced cash position of more than CHF 300 million as of Q1 2019, following receipt of CHF 80 million upfront payment and USD 50 million convertible equity note as a result of license agreement with Eli Lilly, effective in January 2019.
Strategic R&D expenditures increased by CHF 1.5 million (+15%) supporting an ongoing ramp-up in R&D activities, primarily driven by investments in our neurodegenerative disease therapeutics development and discovery programs, most notably ACI-35.
IFRS net income of CHF 63.6 million and Non-IFRS income of CHF 60.7 million.

Research & Development Highlights Q1 2019

License agreement signed with Lilly to research and develop Tau aggregation inhibitor small molecules for the potential treatment of Alzheimer’s disease and other neurodegenerative diseases. The terms include upfront payment of CHF 80 million, USD 50 million convertible equity note, CHF 60 million in potential near-term milestones, as well as other milestones up to approximately CHF 1.68 billion, and tiered royalty payments in the low double digits.
Presented new data on alpha-synuclein PET Tracer at the Alzheimer’s and Parkinson’s Diseases Congress (AD/PD) Lisbon, Portugal, March 26–31, 2019.
New clinical data on AC Immune’s novel next generation Tau PET-Tracer presented by licensing partner, Life Molecular Imaging, at AD/PD.
Genentech, a member of Roche Group, commenced recruitment for a second Phase 2 trial of AC Immune’s anti-Tau monoclonal antibody, RG6100 (MTAAU9937A, RO7105705), in moderate AD, supplementing a separate Phase 2 trial to evaluate its efficacy and safety in participants with prodromal to mild AD.
Roche discontinued CREAD 1 and CREAD 2, Phase 3 studies of crenezumab and presented an interim analysis of CREAD studies at AD/PD on March 27, 2019.
The landmark Alzheimer’s Prevention Initiative (API) trial of crenezumab, for which data are expected in Q1 of 2022, is continuing in cognitively healthy individuals in Colombia with an autosomal dominant mutation who are at high risk of developing familial AD.

Analysis of Financial Statements for the Three Months Ended March 31, 2019

Revenues

Revenues for the first quarter of 2019 increased CHF 73.6 million compared to 2018, driven by recognition of CHF 73.9 million from the right-of-use license and research and development activities. Revenues fluctuate as a result of payments associated with our collaborations with current and potentially new partners, the timing of milestone achievements and the size of each milestone payment.
Research & Development (R&D) Expenses

Total R&D expenditures increased CHF 1.5 million (+15%) for the three months ended March 31, 2019 compared to 2018.
General & Administrative (G&A) Expenses

For the three months ended March 31, 2019, G&A increased CHF 0.6 million (+22%) to CHF 3.3 million. Increase driven by rental and personnel expenses.
IFRS Income/(Loss) for the period

AC Immune had net income after taxes of CHF 63.6 million in 2019 compared with a net loss of CHF 11.6 million for the comparable period in 2018.
Balance Sheet

The Company had a total cash balance of CHF 302.1 million comprised of CHF 222.1 million in cash and cash equivalents and CHF 80.0 million in short-term financial assets. This compares to CHF 186.5 million as of December 31, 2018. The increase of CHF 115.6 million is principally due to the CHF 80 million upfront payment and USD 50 million convertible equity note with Lilly. Further details are available in our Statements of Cash flows on the accompanying Form 6-K.
The Company’s strong cash balance provides enough capital resources to progress through at least Q3 2023, not considering any incoming milestones.
The total shareholders’ equity position increased from December 31, 2018 to CHF 241.9 million from CHF 177.6 million. Further details are available in our corresponding Financial Statements filed on the accompanying Form 6-K.