On August 13, 2019 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial results for the six months ended June 30, 2019 (Press release, Trillium Therapeutics, AUG 13, 2019, View Source [SID1234538647]).

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"We made excellent progress in the second quarter toward achieving two key near-term milestones," said Robert L. Kirkman, M.D., Executive Chair of Trillium Therapeutics. "We have secured a meeting with the U.S. Food and Drug Administration later this quarter to discuss a proposed pivotal trial of intratumoral TTI-621 in patients with cutaneous T-cell lymphoma. We have enrolled patients under our amended TTI-621 intravenous protocol that will allow us to dose cutaneous T-cell lymphoma patients beyond 0.5 mg/kg."

Second Quarter 2019 Financial Results:

As of June 30, 2019, Trillium had a combined cash and cash equivalents and marketable securities balance of $42.8 million, compared to $45.4 million at December 31, 2018. The June 30, 2019 working capital balance was $31.4 million, compared to $34.2 million at December 31, 2018. The decrease in cash and cash equivalents and marketable securities, and the decrease in working capital was due mainly to cash used in operations, partially offset by the cash received from the February 2019 public offering.

Net loss for the six months ended June 30, 2019 of $17.2 million was lower than the loss of $20.9 million for the six months ended June 30, 2018. The net loss was lower due mainly to a net warrant liability revaluation gain of $6.1 million and lower clinical trial related expenses, which were partially offset by a net foreign currency loss of $1.1 million in the current year compared to a net foreign currency gain of $3.0 million in the prior year, and higher manufacturing costs.

On August 13, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported, that it received a single digit million Euro milestone payment from its partner Guangzhou Link Health Pharma Co., Ltd (Link Health) in accordance with the licensing and development agreement for the cancer therapeutic candidate 4SC-205 (Press release, 4SC, AUG 13, 2019, View Source [SID1234538646]).

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Under the 2016 agreement, Link Health received from 4SC the exclusive licensing rights for the development, regulatory submission and marketing of 4SC-205 in China, Hong Kong, Taiwan and Macao and is responsible for performing and financing the clinical development of 4SC-205.

Yan Song, Ph.D., CEO of Link Health, says: "We initiated a Phase I, open label, dose escalation trial to assess the safety, tolerability and pharmacokinetics of LH031 (4SC-205) orally administered in adult patients with advanced solid malignancies or lymphoma. Secondary objectives include to assess the drug candidate’s potential anti-cancer activity."

Jason Loveridge, Ph.D., CEO of 4SC, comments: "We are very pleased that our Chinese partner has successfully advanced 4SC-205 into the next stage of development and initiated the first clinical trial with our drug candidate in Asia. 4SC remains focused on advancing our core drug candidates resminostat and domatinostat, but nonetheless our strategy to monetize and advance non-core assets through partnerships continues to progress well."

On August 13, 2019 Mirati Therapeutics presented the corporate presentation (Presentation, Mirati, AUG 13, 2019, View Source [SID1234538644]).

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On August 13, 2019 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that Tom Kassberg, the company’s Chief Business Officer, will present at the Wedbush PacGrow Healthcare Conference on Wednesday, August 14, 2019 at 1:20 PM ET in New York, NY (Press release, Ultragenyx Pharmaceutical, AUG 13, 2019, View Source [SID1234538643]).

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The live and archived webcast of the company presentations will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

On August 13, 2019 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the second quarter ended June 30, 2019, and provided a corporate update (Press release, VBL Therapeutics, AUG 13, 2019, View Source [SID1234538642]).

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"Our OVAL Phase 3 potential-registration trial of VB-111 in ovarian cancer continues as planned," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The final results from the prior Phase 2 study (presented at ASCO (Free ASCO Whitepaper) in June) which show statistically significant prolongation of overall survival in platinum-resistant patients, strengthen our belief in the potential of VB-111. An important outcome from Phase 2 was the correlation between CA-125 response and survival benefit. Measurement of CA-125 will, therefore, be the focus of our interim analysis in OVAL, planned for year-end 2019."

Second Quarter and Recent Corporate Highlights:

●Two posters on VB-111, in platinum resistant ovarian cancer and in recurrent glioblastoma multiforme (rGBM), were featured at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting, held in June 2019 in Chicago.
°Final data from the prior Phase 2 study in ovarian cancer demonstrated a statistically significant dose dependent increase in median overall survival in patients treated with therapeutic dose vs. low dose of VB-111 (498 days vs. 172.5 days, p=0.03).
°CA-125 biomarker response (GCIG) was reported in 58% of evaluable patients and was predictive of median overall survival (808 days vs. 351 days) in ovarian cancer, in patients treated with a therapeutic dose of VB-111.
Post treatment tumor infiltrating CD8 T-cells and apoptotic cancer cells indicated tumor transformation from immunologically ‘cold’ to ‘hot’, possibly contributing to the favorable clinical outcomes in ovarian cancer.
°Results were presented from a radiographic analysis conducted at the Brain Tumor Imaging Laboratory at UCLA of the Phase 2 and Phase 3 trials of VB-111 in rGBM. This analysis provides independent, quantitative data that priming with VB-111 results in clinically-meaningful activity in rGBM, which can be seen by MRI signature, demonstrates objective response to VB-111 and is correlated with a statistically significant survival advantage.
°VBL’s new gene therapy pharmaceutical grade manufacturing facility in Modiin, Israel, that was established to support the commercial supply of VB-111 for the first indication, was certified by a European Union (EU) Qualified Person (QP) as being in compliance with EU Good Manufacturing Practices (GMP). This important approval is expected to support future commercialization of VB-111.
Second Quarter ended June 30, 2019 Financial Results:

●Cash Position: At June 30, 2019, the Company had cash, cash equivalents and short-term bank deposits totaling $45.1 million and working capital of $39.1 million. The Company expects that its cash, cash equivalents and short-term bank deposits will enable it to fund operating expenses and capital expenditure requirements for at least two years.
●Revenues: Revenues related to VBL’s collaborations were $0.1 million in the second quarter of 2019.
●R&D Expenses: Research and development expenses, net, after government grants, for the quarter ended June 30, 2019, were approximately $3.7 million, compared to approximately $2.9 million in the same period in 2018.
●G&A Expenses: General and administrative expenses for the quarter ended June 30, 2019 were $1.2 million, as in the same period in 2018.
●Comprehensive Loss: VBL reported a net loss for the quarter ended June 30, 2019 of $4.7 million, or ($0.13) per share, compared to a net loss of $4.1 million, or ($0.13) per share, in the quarter ended June 30, 2018.
For further details on VBL’s financials, please refer to Form 6-K filed with the SEC.

Conference Call:

Tuesday, August 13th @ 8:30am Eastern Time

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International: 201-493-6784
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