On August 12, 2016 ProNAi Therapeutics, Inc. (NASDAQ: DNAI), a drug development company focused on advancing targeted therapeutics for the treatment of patients with cancer, today reported its financial and operational results for the second quarter of 2016 (Filing, Q2, ProNAi Therapeutics, 2016, AUG 12, 2016, View Source [SID:1234514537]).

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"During the second quarter, we successfully licensed our first new asset, PNT141, a potent, selective and orally bioavailable small molecule inhibitor of the Cdc7 kinase," said Dr. Nick Glover, President and CEO of ProNAi Therapeutics. "Our goal is to build a broad pipeline consisting primarily of assets that leverage discoveries on the leading edge of cancer biology. PNT141 highlights this strategy as Cdc7 has a central function in both DNA replication and DNA damage response, two mechanisms that are increasingly recognized as having critical roles in driving cancer. In addition to toxicology and manufacturing work, we are conducting a robust preclinical assessment of PNT141 aimed at further informing our clinical development plans and patient selection strategies as we prepare this product candidate for clinical trials."

In June 2016, the company reported that it had suspended development of the cancer drug PNT2258. This decision was informed by a review of the interim data from the Wolverine Phase 2 trial of PNT2258. Although modest efficacy was observed from PNT2258 in this interim analysis, the company did not view these data as robust enough to justify continued development of the drug. The company continues to review these data in order to determine next steps with the asset and technology; however, no further investment in PNT2258 or the underlying DNAi platform by ProNAi is contemplated and the company subsequently has closed its research facility based in Plymouth, Michigan, which supported these programs.

Second Quarter 2016 Financial Results (all amounts reported in U.S. currency)
Total operating expenses for the three months ended June 30, 2016 were $12.9 million compared to $6.6 million for the three months ended June 30, 2015. Total operating expenses for the six months ended June 30, 2016 were $23.6 million compared to $13.3 million for the six months ended June 30, 2015. Total operating expenses included non-cash stock based compensation of $1.3 million and $2.7 million for the three and six months ended June 30, 2016 and of $0.4 and $0.6 for the three and six months ended June 30, 2015, respectively.

Research and development expenses increased to $9.1 million for the three months ended June 30, 2016 from $4.7 million for the three months ended June 30, 2015. Research and development expenses increased to $15.8 million for the six months ended June 30, 2016 from $10.0 million for the six months ended June 30, 2015. These increases were primarily due to a non-recurring $2.8 million restructuring charge related to estimated close-out expenses for PNT2258, a $0.9 million upfront payment for the exclusive license of PNT141 and an increase in personnel-related costs. These increased costs were partially offset by a decrease in third-party manufacturing costs.

General and administrative expenses increased to $3.8 million for the three months ended June 30, 2016 from $1.9 million for the three months ended June 30, 2015. General and administrative expenses increased to $7.8 million for the six months ended June 30, 2016 from $3.3 million for the six months ended June 30, 2015. These increases were primarily due to a $0.3 million non-recurring restructuring charge, increased personnel-related costs and fees incurred in support of activities as a public company and corporate growth and costs pertaining to business development activities.

For the three months ended June 30, 2016, ProNAi incurred a net loss of $12.9 million compared to a net loss of $15.2 million for the three months ended June 30, 2015. For the six months ended June 30, 2016, ProNAi incurred a net loss of $23.4 million compared to a net loss of $23.3 million for the six months ended June 30, 2015. During the three and six months ended June 30, 2015, net loss included a non-cash charge related to the change in fair value of preferred stock warrants of $8.6 million and $10.0 million.

At June 30, 2016, ProNAi had $130.6 million in cash and cash equivalents compared to $150.2 million in cash and cash equivalents at December 31, 2015.
At June 30, 2016, there were 30,220,083 shares of common stock issued and outstanding and stock options to purchase 4,409,724 shares of common stock issued and outstanding.

On August 9, 2016 Ohr Pharmaceutical, Inc. (NasdaqCM: OHRP), an ophthalmology research and development company, reported results for its third quarter ended June 30, 2016 (Filing, Q2, Ohr Pharmaceutical, 2016, AUG 12, 2016, View Source [SID:1234514538]).

"The start of the Phase 3 registration program for Squalamine during the quarter marked a significant milestone in our overall development program for our lead drug candidate," said Jason Slakter, MD, Chief Executive Officer of Ohr. "There remains a significant need for new treatment options that can enhance visual acuity gains in wet AMD and provide a non-invasive treatment option. We believe that Squalamine, when administered as part of a combination therapy, meets these needs and has the potential to set a new standard of care. We look forward to an exciting second half of calendar 2016."

Third Quarter Highlights
· Commenced enrollment in the Phase 3 clinical development program to investigate Squalamine lactate ophthalmic solution, 0.2% ("Squalamine", also known as OHR-102) as a treatment to improve visual acuity for patients with wet AMD.
o The Phase 3 program includes two clinical trials designed as double-masked, placebo-controlled, multicenter, international studies of Squalamine administered topically twice a day in patients with newly diagnosed wet AMD, in combination with Lucentis injections.
o The primary endpoint in both studies is a measurement of visual acuity gain at nine months, which is the most clinically meaningful endpoint for wet AMD patients. Subjects will be followed to two years for safety.
· Appointed David M. Brown, MD to serve as the chair of the Steering Committee for the Phase 3 clinical program of Squalamine in wet-AMD.
o Dr. Brown is Clinical Professor of Ophthalmology at Baylor College of Medicine, vice-chair for research at the Blanton Eye Institute, Houston Methodist Hospital, and partner at Retina Consultants of Houston.
· Completed an in vivo study demonstrating sustained pharmacological anti-angiogenic activity of OHR3031, an angiogenesis inhibitor
o Single intravitreal injection of microparticles containing OHR3031 produced clinically meaningful and statistically significant efficacy six weeks after dose administration in a rabbit model of laser-induced CNV.
o Dose response was observed in the reduction of average CNV lesion areas with OHR3031 compared to vehicle treatment, with the highest dose exhibiting a statistically significant effect at Week 6.
o Magnitude of difference in average CNV lesion size for the high dose of OHR-3031 compared to vehicle treatment at 6 weeks was comparable to that seen at 2 weeks with a currently approved anti-VEGF agent conducted in a previous study.
o OHR3031 was developed using SKS sustained release technology
· Presented two posters on the Squalamine Phase 2 IMPACT study and OHR3031 in vivo studies at the Association for Research in Vision and Ophthalmology (ARVO) Conference in May.

Financial Results for Third Quarter ended June 30, 2016
· For the third quarter ended June 30, 2016, the Company reported a net loss of approximately $7.7 million, or ($0.24) per share, compared to a net loss of approximately $3.3 million, or ($0.11) per share in the same period of 2015.
· For the third quarter ended June 30, 2016, total operating expenses were approximately $7.6 million, consisting of approximately $1.7 million in general and administrative expenses, $5.6 million in research and development expenses, and $0.3 million in depreciation and amortization. This compares to total operating expenses in the same period of 2015 of approximately $3.3 million, consisting of $1.6 million in general and administrative expenses, $1.5 million in research and development expenses, and $0.3 million in depreciation and amortization.
· At June 30, 2016, the Company had cash and cash equivalents of approximately $17.6 million. This compares to cash and equivalents of approximately $28.7 million at September 30, 2015.

Financial Results for the Nine-Months ended March 31, 2016
· For the nine months ended June 30, 2016, the Company reported a net loss of approximately $19.1 million, or ($0.61) per share, compared to a net loss of approximately $11.3 million, or ($0.41) per share in the same period of 2015.
· For the nine months ended June 30, 2016, total operating expenses were approximately $17.8 million, consisting of $5.8 million in general and administrative expenses, $11.8 million of research and development expenses, and $0.9 million in depreciation and amortization. This compares to total operating expenses of $14.3 million in the same period of 2015, comprised of approximately $5.7 million in general and administrative expenses, $7.4 million in research and development expenses, and $0.9 million in depreciation and amortization.

Conference Call & Webcast
Tuesday, August 9th at 5:00pm Eastern Time
Domestic: 877-407-0789
International: 201-689-8562
Conference ID: 13642605
Webcast: View Source

Replays – Available through August 16, 2016
Domestic: 877-870-5176
International: 858-384-5517
Conference ID: 13642605

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On August 11, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) ("the company"), an oncology-focused biotechnology company, reported key accomplishments and its financial results for the second quarter of 2016, which ended June 30, 2016 (Filing, Q2, Cellectar Biosciences, 2016, AUG 12, 2016, View Source [SID:1234514544]).
Corporate highlights for the quarter include:

· USPTO issued patent for CLR 131 and other radiotherapeutics for the treatment of cancer stem cells in combination with external beam treatment

· USPTO issued patent for CLR 1600 series PDC’s protecting assets generated through the conjugation of our delivery vehicle with paclitaxel

· USPTO patent publication related to our delivery vehicle protecting assets generated through the conjugation of any existing or future cytotoxic agents

· Results of preclinical study of 1602, one of our paclitaxel PDC’s demonstrating improved in vivo cancer tumor targeting compared to other cells

· Completion of the first phase of NCI SBIR fast track grant; a preclinical study of CLR 125 which demonstrated activity in triple negative breast cancer models

· Closing of $8M financing

· Achieved all Nasdaq requirements for continued listing, successfully closing the listing qualifications matter

"In addition to expanding and strengthening our intellectual property portfolio this past quarter, we enhanced the company’s capital structure and continued to successfully execute on the corporate objectives established almost a year ago, including our rapid pivot to a therapeutic focused research and development company," said Jim Caruso, president and CEO of Cellectar Biosciences. "We now look forward to upcoming cohort 2 performance results of CLR 131 for Multiple Myeloma as well the first half of 2017 initiation of our NCI supported Phase 2 clinical study of CLR 131in hematologic malignancies."

Financial Results for 2Q 2016

During the second quarter of 2016, the company reported research and development expenses of $1.0 million, a reduction of $0.4 million from the second quarter of 2015. This improvement continues to be attributable to the company’s shift in strategic focus to therapeutic compound research and development efforts exclusively and the streamlined clinical trial approach it implemented during the second half of 2015.

Cellectar’s general and administrative expenses for second quarter 2016 totaled $1.4 million, which was $0.6 million higher than the prior year period. A significant portion of this increase was driven by specific charges related to legal fees and other consulting services that will not recur, in addition to increased personnel costs. Loss from operations was $2.3 million, which was similar to the same period last year.

The Company ended the second quarter with $7.9 million in cash and cash equivalents, compared to $3.9 million in cash and cash equivalents on December 31, 2015. The company estimates that its available cash and cash equivalents should fund its planned operations into the first quarter of 2017. The company expects that additional capital will be required to complete its planned clinical and preclinical development.

Cellectar will be holding a conference call at 8:30 AM ET on Monday, August 15, 2016 to review the company’s performance, as well as these financial results. The call can be accessed by calling 888-646-8293. The call will also be webcast via View Source, and replays will be available via the Investor Relations section of the company’s website: investor.cellectarbiosciences.com.

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On August 8, 2016 La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, reported financial results for the three and six months ended June 30, 2016 (Filing, Q2, La Jolla Pharmaceutical, 2016, AUG 12, 2016, View Source [SID:1234514551]).

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Results of Operations

As of June 30, 2016, La Jolla had $100.6 million in cash and cash equivalents, compared to $126.5 million as of December 31, 2015. The decrease in cash and cash equivalents was primarily due to net cash used for operating activities. Based on current operating plans and projections, La Jolla believes that its current cash and cash equivalents are sufficient to fund operations into 2018.

La Jolla’s net cash used for operating activities for the six months ended June 30, 2016 was $25.1 million, compared to net cash used for operating activities of $11.2 million for the same period in 2015. La Jolla’s net loss for the three and six months ended June 30, 2016 was $15.6 million and $32.0 million, or $0.90 per share and $1.86 per share, respectively, compared to a net loss of $10.7 million and $19.6 million, or $0.70 per share and $1.29 per share, respectively, for the same periods in 2015. During the three and six months ended June 30, 2016, La Jolla recognized contract revenue of approximately $0.3 million and $0.5 million, respectively. The net loss includes non-cash, share-based compensation expense of $3.3 million and $7.0 for the three and six months ended June 30, 2016, respectively, compared to $3.9 million and $7.3 million, respectively, for the same periods in 2015.

The increases in net cash used for operating activities and net loss in the 2016 periods as compared to the 2015 periods were primarily due to increased development costs associated with our ATHOS 3 Phase 3 trial of LJPC-501 in patients with catecholamine-resistant hypotension and our Phase 1 trial of LJPC-401 in patients with iron overload. There also were increases in personnel and facility costs associated with the support of these increased development activities.

"The first half of 2016 was a productive period for La Jolla, highlighted by the continued enrollment of our ATHOS 3 Phase 3 trial of LJPC-501 and encouraging interim data from our Phase 1 trial of LJPC-401," said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. "Catecholamine-resistant hypotension and iron overload remain significant unmet medical needs, and we remain dedicated to bringing our potentially important therapies to patients as expeditiously as possible. We plan to report results from our Phase 1 trial of LJPC-401 in September 2016 and from our ATHOS 3 Phase 3 trial of LJPC-501 in the first quarter of 2017."

On August 11, 2016 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported its financial results for the second quarter ended June 30, 2016 (Filing, Q2, BioLineRx, 2016, AUG 11, 2016, View Source [SID:1234514504]).

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Highlights and achievements during second quarter of 2016 and to date:

· Submission of regulatory filings to initiate Phase 2a study in pancreatic cancer for BL-8040 in combination with Merck’s KEYTRUDA, under immuno-oncology collaboration with Merck announced earlier this year

· Signing of additional immuno-oncology collaboration, this time with MD Anderson Cancer Center, for second Phase 2a study in pancreatic cancer for BL-8040 in combination with Merck’s KEYTRUDA

· Continued enrollment in large (n=194), randomized Phase 2b study for BL-8040 as consolidation treatment for AML patients following standard induction treatment

· Commercial launch of BL-5010 as OTC treatment for non-surgical removal of skin lesions by Omega Pharma (a division of Perrigo), following CE Mark approval in March

· In-licensing of liver fibrosis project under Novartis collaboration

· Philip A. Serlin appointed Chief Executive Officer, effective October 2016

Expected upcoming significant milestones for remainder of 2016:

· Initiation of Phase 2a study in pancreatic cancer, under immuno-oncology collaboration with Merck, following expected regulatory approval in Q3 2016

· Second Phase 2a immuno-oncology study in pancreatic cancer, under collaboration with MD Anderson Cancer Center, expected to commence by end of 2016

· Full set of data from Phase 2a study for BL-8040 in r/r AML to be presented at the Society of Hematologic Oncology (SOHO) annual meeting, September 7-10, 2016, in Houston, Texas

· Partial results from Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation expected by end of 2016

· Regulatory submission for BL-7010 clinical efficacy study, for marketing purposes as food supplement

· Expansion of commercial rollout of BL-5010 by Omega to additional countries and development of 2nd OTC indication for the product

Philip A. Serlin, Chief Financial and Operating Officer of BioLineRx, remarked, "The second quarter of 2016 highlighted the continued execution of our plans as we advance and expand our lead oncology platform, BL-8040; see the initial market penetration of BL-5010; continue the development of BL-7010 as a food supplement; and maintain active asset screening and in-licensing activities with Novartis."

"We are pleased to have entered into an immuno-oncology collaboration with MD Anderson for a second Phase 2a study of BL-8040 with Merck’s KEYTRUDA in pancreatic cancer, which provides additional validation of the potential of our lead oncology drug platform in the cancer immunotherapy space. We continue to examine other potential collaborations in this space. In addition, we are looking forward to announcing full results from our successful Phase 2a study for relapsed and refractory AML at the upcoming Society of Hematology Oncology Meeting in September and we continue to push forward in our Phase 2b trial in an earlier treatment line for AML as a consolidation treatment following standard induction treatment. We also look forward to initiating our Phase 2a study in pancreatic cancer under our collaboration with Merck, expected by the end of this quarter," added Mr. Serlin.

"BL-5010, our first product in the market, is already being sold in a number of countries in Europe. Omega Pharma plans to continue to gradually launch the product in additional European countries over the next 6-9 months, and beyond that time frame, to additional territories. To date, we have not recorded material revenues from this collaboration, but we expect revenues to gradually increase as the first product launch expands and the second product launch commences. In addition, we have in-licensed a drug candidate for the treatment of liver fibrosis, specifically nonalcoholic steatohepatitis (NASH), under our strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates, and we expect to in-license additional promising projects to the collaboration in the next few months," continued Mr. Serlin.

"In closing, we ended the second quarter with $41.8 million of cash on our balance sheet. With our focus on achieving our expected milestones, we remain well positioned to carry out our strategic and operational plans," Mr. Serlin concluded.

2

Financial Results for Second Quarter Ended June 30, 2016

Research and development expenses for the three months ended June 30, 2016 were $2.7 million, a decrease of $0.2 million, or 5.2%, compared to $2.9 million for the comparable period in 2015. The small decrease resulted primarily from lower spending on BL-7010 in the 2016 period, partially offset by increased spending related to clinical trial preparations for BL-8040. Research and development expenses for the six months ended June 30, 2016 were $5.3 million, a decrease of $0.8 million, or 13.5%, compared to $6.1 million for the comparable period in 2015. The decrease resulted primarily from lower expenditures for BL-7010 during the 2016 period, as well as the conclusion of one of the clinical trials for BL-8040 in 2015.

Sales and marketing expenses for the three months ended June 30, 2016 were $0.3 million, similar to the comparable period in 2015. Sales and marketing expenses for the six months ended June 30, 2016 were $0.5 million, similar to the comparable period in 2015.

General and administrative expenses for the three months ended June 30, 2016 were $0.9 million, a decrease of $0.1 million, or 12.5%, compared to $1.0 million for the comparable period in 2015. The small decrease resulted primarily from a decrease in salary-related payments and depreciation. General and administrative expenses for the six months ended June 30, 2016 were $1.8 million, similar to the comparable period in 2015.

The Company’s operating loss for the three months ended June 30, 2016 amounted to $3.8 million, compared with an operating loss of $4.2 million for the corresponding 2015 period. The Company’s operating loss for the six months ended June 30, 2016 amounted to $7.6 million, compared with an operating loss of $8.5 million for the corresponding 2015 period.

Non-operating income (expenses) for the three and six months ended June 30, 2016 and 2015 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet. These fair-value adjustments, which were not material in the 2016 periods, are highly influenced by the Company’s share price at each period end (revaluation date).

Financial income (expenses), net for the three and six months ended June 30, 2016 and 2015 primarily relate to investment income earned on bank deposits, as well as banking fees. The decrease from 2015 to 2016 reflects a lower cash balance and a continued reduction in global investment yields.

The Company’s net loss for the three months ended June 30, 2016 amounted to $3.7 million, compared with a net loss of $4.8 million for the corresponding 2015 period. The Company’s net loss for the six months ended June 30, 2016 amounted to $7.2 million, compared with a net loss of $9.1 million for the corresponding 2015 period.

The Company held $41.8 million in cash, cash equivalents and short-term bank deposits as of June 30, 2016.

3
Net cash used in operating activities was $7.4 million for the six months ended June 30, 2016, compared with net cash used in operating activities of $7.1 million for the comparable period in 2015. The $0.3 million increase in net cash used was primarily the result of a decrease in trade payables and accruals.

Net cash provided by investing activities for the six months ended June 30, 2016 was $4.2 million, compared to net cash used in investing activities of $17.9 million for the comparable period in 2015. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and other investments during the respective periods.

Net cash provided by financing activities for the six months ended June 30, 2016 was $1.5 million, compared to net cash provided by financing activities of $28.6 million for the comparable period in 2015. The decrease in cash flows from financing activities reflects the underwritten public offering which was completed in March 2015.