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MATEON REPORTS FIRST QUARTER 2019 FINANCIAL RESULTS

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.

Seattle Genetics to Present at RBC Capital Markets 2019 Global Healthcare Conference

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.

Omeros to Present at the UBS Global Healthcare Conference

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.

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.

AC Immune Reports Q1 2019 Financial Results and Business Update

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]).

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.

CLEVELAND BIOLABS REPORTS FIRST QUARTER 2019 FINANCIAL RESULTS AND DEVELOPMENT PROGRESS

On May 15, 2019 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the first quarter ended March 31, 2019 (Press release, Cleveland BioLabs, MAY 15, 2019, View Source [SID1234536339]).

Cleveland BioLabs reported a net loss of $(0.9) million, excluding minority interests, for the first quarter of 2019, or $(0.08) per share, compared to a net loss, excluding minority interests, of $(1.2) million, or $(0.11) per share, for the same period in 2018. The decrease in net loss was primarily due to reduced research and development activity due to previously disclosed vendor delays in in the analytical analyses required to complete the biocomparability study and a decrease in General and Administrative costs partially offset by an increase in the non-cash adjustment to our warrant liabilities. The biocomparability study was completed during the first quarter.

As of March 31, 2019, the Company had $3.3 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund operations into December 2019.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The development, pursuit of regulatory approval and commercialization for entolimod as a medical radiation countermeasure remains our top priority.

Further Financial Results

Revenue for the first quarter of 2019 decreased to $0.20 million compared to $0.23 million for the first quarter of 2018. The net decrease was primarily attributable to decreased revenue from our Joint Warfighter Medical Research Program ("JWMRP") contract from the Department of Defense ("DoD") for the continued development of the entolimod as a medical radiation countermeasure partially offset by increased revenue from our service contract with Incuron.

Research and development costs for the first quarter of 2019 decreased to $0.5 million compared to $1.3 million for the first quarter of 2018. The reduction in research and development costs is due to a $0.57 million reduction in spending for biodefense applications of entolimod, $0.26 million decrease in expenses related to the oncology applications of the entolimod family of compounds, and a $0.04 million reduction in spending on Panacela’s product candidates partially offset by a $0.05 million increase in expenses related to the Curaxins.

General and administrative costs for the first quarter of 2019 decreased to $0.47 million compared to $0.73 million for the first quarter of 2018. This decrease was primarily attributable to $0.15 million decrease in property tax expense, $0.06 million decrease in expense relating to a one-time settlement for the previously completed research contracts with the Russian Ministry of Trade, and $0.05 million decrease in legal and professional fees.