On August 8, 2019, Stemline Therapeutics, Inc. ("Stemline" or the "Company") reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, as representative of the several underwriters named therein (the "Underwriters") (Filing, 8-K, Stemline Therapeutics, AUG 9, 2019, View Source [SID1234538565]). Pursuant to the Underwriting Agreement, the Company agreed to sell to the Underwriters, in a firm commitment underwritten public offering, 5,000,000 shares (the "Firm Shares") of the Company’s common stock, $.0001 par value per share ("Common Stock"), at a price to the public of $15.25 per share, less underwriting discounts and commissions. In addition, pursuant to the Underwriting Agreement, the Company has granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 750,000 shares of Common Stock (the "Additional Shares," together with the Firm Shares, the "Shares"). The transactions contemplated by the Underwriting Agreement are expected to close on August 13, 2019, subject to the satisfaction of customary closing conditions. A copy of the Underwriting Agreement is attached hereto as Exhibit 1.1 and is incorporated by reference herein.

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J.P. Morgan Securities LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering.

The gross proceeds to the Company are expected to be approximately $76,250,000, assuming no exercise of the option to purchase Additional Shares and before deducting underwriting discounts and commissions and estimated expenses payable by the Company associated with the offering.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

Alston & Bird LLP, counsel to the Company, delivered an opinion as to the validity of the Shares, a copy of which is attached hereto as Exhibit 5.1 and is incorporated by reference herein.

On August 9, 2019 Lion TCR Pte. Ltd., a clinical-stage Biotech company focused on development of innovative engineered T cell immunotherapy against viral-related cancer and chronic Hepatitis B infection, reported on 29 July 2019 that it has signed an agreement with Dalian Lvshun District Government at the 10th Singapore-Liaoning Economic and Trade Council Meeting (SLETC) to develop cell manufacturing and research facilities for cancer treatment (Press release, Lion TCR, AUG 9, 2019, View Source [SID1234538769]). The 5,000-sqm facility, built by Dalian Municipal Government, will support Lion TCR’s development and commercialisation of cell therapy products in China in addition to Lion TCR’s facility at the China-Singapore Guangzhou Knowledge City. Lion TCR shall utilize GMP (Good Manufacturing Practice) certified entities for the production of advanced cellular immunotherapy products for clinical trials and for future commercial products. The facility design and process will comply with both China CDE and internationally recognized GMP guidelines.

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The 10th SLETC was chaired by Mr. Masagos Zulkifli, Singapore’s Minister for the Environment and Water Resources, and Mr. Tang Yijun, Liaoning Governor, the Co-Chairmen of SLETC. At the council meeting, 11 Singapore companies including Lion TCR signed project agreements to provide greater connectivity, sustainability, technology and healthcare in Liaoning. Singapore is Liaoning’s third largest foreign investor with a total investment of about S$19 billion (95 billion yuan). Minister Masagos told the Party Secretary and Mayor of Dalian City at their meeting: "Singapore looks forward to deepening cooperation with Dalian in environmental protection, new energy, interconnection, biomedical, petrochemical, marine fishery, food processing, sustainable development and other fields."

Mr. Stephen Lim, CEO of Lion TCR commented that "Lion TCR looks forward to using this Dalian GMP cell therapy facilities as a manufacturing base for our China commercialisation needs. As a stand-alone building is required for cell therapy GMP application in China, this offer to build with option for Lion to purchase by the Dalian Government is a great help to Lion as it frees our immediate cashflow for continual research and on-going clinical trials."

Mr. Masagos Zulkifli, Singapore’s Minister for the Environment and Water Resources, Singapore Co-Chair of Singapore-Liaoning Economic and Trade Council (fourth from left); Mr. Stephen Lim, CEO of Lion TCR (third from left); Dr. Victor Li, Chairman of Lion TCR (third from right).

On August 9, 2019 NEC Corporation (NEC; TSE: 6701) and CYTLIMIC Inc. reported that financing of 1.3 billion yen (around US$ 12 million at current rate) was completed through the achievement of the milestones, including the first IND filing of CYT001*, pursuant to the agreement with current shareholders; i.e., NEC Corporation, NEC Capital Solutions Limited, Fast Track Initiative, Inc., and SMBC Venture Capital Co., Ltd. In total, 2.3 billion yen (around US$ 21 million) has been raised since the establishment of CYTLIMIC in December 2016 (Press release, NEC, AUG 9, 2019, View Source [SID1234538959]).

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In recent years, Immune-Checkpoint Inhibitors (ICI), such as anti-PD-(L)1 drug, have been expanding their applications; However, a combination of ICI with other drugs are still needed for more than 70% of patients who don’t respond to ICI alone. Among those combination drugs, cancer vaccine is considered as a promising approach to turn "Cold tumors to Hot ones" and to make ICI work. CYT001 is designed to effectively turn "Cold tumors to Hot ones" with the AI-designed optimized shared-antigen peptides, and an optimized combination adjuvant of Poly ICLC (Hiltonol) and LAG-3Ig (Eftilagimod alpha or IMP321). The recent financing allows CYTLIMIC to conduct further clinical trials for the POC establishment of CYT001.

On August 9, 2019 Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported financial results for the second quarter ended June 30, 2019 (Press release, Leap Therapeutics, AUG 9, 2019, View Source [SID1234538543]).

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"We recently presented positive data from our clinical study of DKN-01 plus KEYTRUDA which demonstrated higher survival and objective response outcomes in patients with advanced gastroesophageal junction and gastric cancer whose tumors expressed high levels of DKK1 (DKK1-high). As we have seen with the single agent partial responses in patients with endometrial cancer, DKN-01’s activity continues to be impressive in biomarker-targeted patient populations," commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. "In addition, we have enrolled our first patients in the triple chemoimmunotherapy study of TRX518 in combination with BAVENCIO and cyclophosphamide."

Recent Developments

·DKN-01 CLINICAL INVESTIGATOR WEBCAST: On August 6, 2019, Leap hosted a DKN-01 program update webcast with Samuel J. Klempner, MD, Assistant Professor, Massachusetts General Hospital Cancer Center and Harvard Medical School, and Rebecca C. Arend, MD, Assistant Professor and Associate Scientist, Gynecologic Oncology Clinic, UAB Comprehensive Cancer Center Experimental Therapeutics Program. A replay of the webcast and the presentation slides are available under "Events & Presentations" in the Investor section of Leap’s website, View Source

· DKN-01 in ESOPHAGOGASTRIC CANCER: Leap presented data from the KEYNOTE-731 clinical study evaluating DKN-01 in combination with KEYTRUDA in patients with advanced esophagogastric cancer. In gastroesophageal junction and gastric cancer patients who had not received prior PD-1/PD-L1 therapy, the combination of DKN-01 plus KEYTRUDA demonstrated improved outcomes in patients whose tumors are DKK1-high. DKK1-high patients experienced 22.1 weeks median progression free survival (PFS) and 31.6 weeks median overall survival (OS), with a 50% overall response rate (ORR) and 80% disease control rate (DCR) in ten evaluable patients. DKK1-low patients experienced 5.9 weeks PFS and 17.4 weeks OS, with a 20% DCR in fifteen evaluable patients. PD-L1 Combined Positive Scores (CPS) did not predict efficacy to the combination of DKN-01 plus KEYTRUDA. In multi-variate analysis, DKK1-high status correlated with longer PFS independent of PD-L1 CPS.

·DKN-01 in GYNECOLOGICAL CANCERS: The clinical study of DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological cancers has been expanded to include focused cohorts of patients with carcinosarcoma. Overall, ninety-six patients have been enrolled in the study, and enrollment is ongoing. Additional response and biomarker data will be available in September at the International Gynecologic Cancer Society Annual Global Meeting.

·TRX518 TRIPLE COMBINATION THERAPY: Leap enrolled the first patients in the clinical trial evaluating TRX518 in combination with cyclophosphamide chemotherapy and BAVENCIO. Dose escalation in the study is ongoing.

· $21 MILLION EQUITY COMMITMENT FACILITY: Leap entered into purchase agreements with Lincoln Park Capital Fund, LLC (LPC) pursuant to which Leap sold $1 million in common stock and has the option, but not the obligation, to sell to LPC up to an additional $20 million in shares of common stock in tranches over a twenty-four month period. The price of shares sold will be based on the market prices prevailing at the time of each sale to LPC. There is no upper limit as to the price per share that LPC may pay for future stock issuances under the agreement, and Leap will control the timing and amount of any future sales.

Selected Second Quarter 2019 Financial Results

Net loss was $8.4 million for the second quarter 2019, compared to $7.4 million for the same period in 2018. This increase was primarily due to an increase in clinical development expense and the recording of a loss in the second quarter 2018 as a result of a decrease in the fair value of the warrant liability.

Research and development expenses were $6.1 million for the second quarter 2019, compared to $4.2 million for the same period in 2018. This increase was primarily due to an increase in clinical trial expenses associated with an increase in patient enrollment and an increase in consulting fees and payroll expenses, partially offset by a decrease in manufacturing costs related to clinical trial material.

General and administrative expenses were $2.3 million for the second quarter 2019, compared to $2.6 million for the same period in 2018. This decrease was primarily due to a decrease in legal, audit and consulting fees.

Cash, cash equivalents and marketable securities totaled $15.7 million at June 30, 2019. Research and development incentive receivables, current and long term, totaled approximately $1.0 million at June 30, 2019. Subsequent to the end of the quarter, Leap announced the commitment facility with LPC and sold $1.0 million in common stock.

On August 9, 2019 Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) reported that it will announce its second quarter 2019 financial results after market close on Wednesday, August 14, 2019 (Press release, Titan Pharmaceuticals, AUG 9, 2019, View Source;conference-call-to-follow-300899215.html [SID1234538567]). Following the release, Titan management will host a conference call at 4:30 p.m. EDT / 1:30 p.m. PDT to review the financial results and discuss business developments in the period.

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The conference call will be hosted by Sunil Bhonsle, President and CEO; Dane Hallberg, Executive Vice President and Chief Commercial Officer; Brian Crowley, Vice President of Finance; and Marc Rubin, M.D., Executive Chairman.

The live conference call may be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and providing passcode 9110840. The call will also be broadcast live and archived on Titan’s website at www.titanpharm.com/news/events.