On August 8, 2017 Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers, reported financial results for the quarter ended June 30, 2017 (Filing, Q2, Stemline Therapeutics, 2017, AUG 8, 2017, View Source [SID1234520201]). The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones:

SL-401 In Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

· The SL-401 pivotal Phase 2 trial enrolled 45 BPDCN patients in Stages 1, 2 and 3. Stage 3 was prospectively designed to support potential registration.

· During the quarter, we presented updated data from Stages 1 and 2 of the Phase 2 trial at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Madrid, Spain.

· Analysis of Phase 2 data, inclusive of Stage 3, is ongoing and we remain on track to announce top-line results in 2H17. We are also targeting a medical conference to present more detailed results later this year.

· To ensure ongoing patient access to SL-401, we are enrolling both first-line and relapsed/refractory BPDCN patients in an additional cohort.

· Depending on the data from the trial, we plan to use the results generated, along with other relevant data, to support the filing of a Biologics License Application (BLA) for approval in BPDCN. We continue to anticipate a possible BLA filing could begin in 4Q17 or 1Q18.

Additional Clinical Trials

· Clinical trials evaluating SL-401 are ongoing in additional indications including certain myeloproliferative neoplasms (MPN), acute myeloid leukemia (AML), and multiple myeloma, as a single agent or in combination with other agents. We expect to provide updates on these studies later this year and into next year.

· SL-801, a novel XPO1 inhibitor, is being evaluated in a Phase 1 trial of patients with advanced solid tumors. SL-701 has completed dosing in a Phase 2 trial of patients with second-line glioblastoma. We are targeting medical conferences for updates on both of these studies later this year.

Second Quarter 2017 Financial Results Review

Stemline ended the second quarter of 2017 with $93.2 million in cash, cash equivalents and investments, as compared to $105.8 million as of March 31, 2017, which reflects a use of cash of $12.6 million for the quarter. The company ended the second quarter of 2017 with 25.2 million shares outstanding.

For the second quarter of 2017, Stemline had a net loss of $15.5 million, or $0.66 per share, compared with a net loss of $9.3 million, or $0.52 per share, for the same period in 2016.

Research and development expenses were $11.5 million for the second quarter of 2017, which reflects an increase of $4.6 million, or 67%, compared with $6.9 million for the second quarter of 2016. The higher costs are primarily driven by an increase of $2.1 million in manufacturing expenses to support our potential BLA filing for SL-401. We also incurred $1.2 million in higher costs for regulatory support of our potential BLA filing for SL-401. Additionally, we incurred higher compensation expense as a result of increased headcount.

General and administrative expenses were $4.5 million for the second quarter of 2017, which reflects an increase of $1.6 million, or 57%, compared with $2.9 million for the second quarter of 2016. The increase in expense was primarily attributable to $0.7 million in pre-launch expenses in support of a potential commercialization of SL-401 in BPDCN, if marketing approval from the FDA is granted. The increase in costs was also driven by $0.4 million in higher legal expense as a result of the class action lawsuit, as well as a $0.3 million increase in non-cash stock-based compensation expense.

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Dynavax Technologies has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On August 7, 2017 SignalRx Pharmaceuticals Inc., a clinical-stage company developing novel small-molecules therapeutics to inhibit key orthogonal and synergistic oncotargets for the treatment of cancer, reported that it has received $2-million non-dilutive funding to advance the preclinical development of their proprietary and first-in-class small-molecule epigenetic-kinase inhibitors as anticancer therapeutics (Press release, SignalRx, AUG 7, 2017, http://www.ireachcontent.com/news-releases/signalrx-awarded-2m-phase-ii-sttr-grant-from-the-national-cancer-institute-for-the-development-of-epigenetic-kinase-inhibitors-as-anticancer-agents-638966263.html [SID1234527321]).

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SignalRx was awarded a Phase II Small Business Technology Transfer Research (STTR) grant from the National Cancer Institute (NCI), a division of the National Institutes of Health (NIH), to support further preclinical development of SignalRx’s novel epigenetic-kinase inhibitors targeting PI3 kinase (PI3K) and the bromodomain protein BRD4. The principal investigator on the STTR grant is SignalRx’s scientific advisor Dr. Donald Durden, MD, PhD who also serves as the academic collaborator for the grant while in his capacity as the Associate Director for Pediatric Oncology at the Moores UCSD Cancer Center at the University of California, San Diego.

Highlights of the dual BRD4-PI3K inhibition approach include:

Demonstrated efficacy in several mouse tumor models.
Demonstrated to be much safer in vivo over combinations of individual BRD4 & PI3K inhibitors.
Overcomes barrier of additive toxicity to combining drugs.
Overcomes cancer resistance mechanisms.
Increases potential patient population.
Provides maximal pharmacodynamic inhibition in individual cancer cells (8X greater).
Molecular chemotypes distinct from existing competitor single agents.
Opportunity to develop more complex anticancer drug combinations.
"This large STTR grant award by the NCI follows on the heels of our proof-of-concept publication recently in PNAS and supports a change in cancer-development dogma from one-molecule one-target approaches to develop a single molecule that inhibits carefully-selected multi-targets resulting in augmented anti-cancer efficacy with less toxicity" said Donald L. Durden, MD, PhD. "This new approach paves the way for more sophisticated and cost-effective combinations in cancer patients resulting in longer duration of benefits in more patients."

"There is an unmet need in oncology for more effective and especially more durable treatments. Despite new drugs aimed at new exciting cancer targets, these drugs only benefit the patient for a short time" said Dr. Joe Garlich, Chief Scientific Officer at SignalRx. "More durable treatments are now recognized to require combinations of drugs, but optimal combinations of drugs are not achievable due to additive toxicities of the individual drugs in the combination. Our technology, creating single drugs with multiple mechanisms of action mimicking drug combinations, allows for effective combinations of drug mechanisms to be used with less toxicity and potentially more durability (long lasting)."

SignalRx is interested in partnering discussions to take these novel small molecules through clinical trials together with companion diagnostics for streamlined development and approval.

On August 7, 2017 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported a collaboration with Kyukyu Pharmaceutical Co., Ltd. (hereafter, Kyukyu Pharmaceutical) to commercialize generic transdermal fentanyl citrate patches for long-acting cancer pain relief (Press release, Daiichi Sankyo, AUG 7, 2017, View Source [SID1234520062]).

The fentanyl citrate patches are a once-daily transdermal opioid analgesic for treatment of moderate to severe cancer pain, and are a generic formulation of Fentos Tape.

Kyukyu Pharmaceutical is currently applying for marketing authorization from the Japanese Ministry of Health, Labour and Welfare. Following the successful obtainment of that authorization, Kyukyu Pharmaceutical will handle manufacturing, and Daiichi Sankyo will handle marketing and promotion activities, for this product.

Daiichi Sankyo expects that the commercialization of generic transdermal fentanyl citrate patches will help to expand our product lineup of opioid analgesics and will offer a novel treatment option to cancer patients and healthcare providers in Japan.

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Mannkind has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Mannkind, 2017, AUG 7, 2017, View Source [SID1234521710]).

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