On November 1, 2016 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, reported third quarter financial results. As of September 30, 2016, cash, cash equivalents and short-term investments totaled $207.6 million (Press release, OncoMed, NOV 1, 2016, View Source [SID1234516150]).

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"OncoMed remains focused on execution across our pipeline, completing enrollment in two randomized Phase 2 trials for demcizumab and tarextumab and driving toward randomized Phase 2 results and potential partner opt-ins in the first half of 2017," said Paul J. Hastings, Chairman and Chief Executive Officer. "Additionally, we will continue to generate new data on multiple compounds in the clinic, and we expect to file INDs for two immuno-oncology programs in late 2016 though the first half of 2017."

Q3 Highlights

Completed enrollment of 207 patients a month ahead of schedule in the Phase 2 YOSEMITE trial of demcizumab (anti-DLL4, OMP-21M18) in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in first-line metastatic pancreatic cancer. Topline results are expected in the first half of 2017, enabling a potential opt-in by Celgene Corporation (Celgene).

Completed enrollment of 145 previously untreated patients with extensive-stage small cell lung cancer (SCLC) three months ahead of schedule in the Phase 2 PINNACLE clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) in combination with etoposide and platinum-based chemotherapy. Topline are results expected in the first half of 2017, enabling a potential opt in by GlaxoSmithKline (GSK).

Presented interim data from the Phase 1b clinical trials of vantictumab (anti-Fzd, OMP-18R5) and ipafricept (FZD8-Fc, OMP-54F28) in pancreatic cancer at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress. OncoMed expects to submit data packages for both vantictumab and ipafricept to Bayer Pharma AG (Bayer) for opt-in consideration during the first half of 2017.
Development updates

OncoMed’s Phase 2 DENALI clinical trial of demcizumab in combination with carboplatin/pemetrexed in first-line non-small cell lung cancer (NSCLC) has enrolled 81 patients as of October 31, 2016. Based on the evolving treatment landscape for front-line NSCLC, OncoMed has stopped further enrollment of patients in this Phase 2 randomized clinical trial and plans to continue to treat currently enrolled patients and analyze the data from those patients in time to support the YOSEMITE data and the potential opt-in package in the first half of 2017. Additionally, OncoMed will supplement the opt-in package with interim safety, biomarker, and early efficacy data from its ongoing Phase 1b trial of demcizumab combined with pembrolizumab. OncoMed anticipates having response rate, progression-free survival, interim overall survival and safety data for DENALI in parallel with the results of YOSEMITE. DENALI data combined with the Phase 1b combination data with demcizumab and pembrolizumab will inform future development of demcizumab in NSCLC.

GSK has notified OncoMed of its decision to focus its current collaboration with OncoMed on tarextumab in SCLC based on the PINNACLE study and to terminate its option on the brontictuzumab (anti-Notch1, OMP-52M51) program. As a result of the termination, OncoMed will retain the worldwide rights to develop brontictuzumab.

OncoMed will continue its ongoing efforts with investigators to plan the conduct of a Phase 1b clinical trial of brontictuzumab in combination with trifluridine and tipiracil tablets (Lonsurf) in third-line colorectal cancer. The trial includes enrollment of biomarker-positive patients whose tumors express the activated form of Notch1. OncoMed has previously presented Phase 1 data that suggest brontictuzumab has single-agent activity in patients with tumors that are positive for the Notch1 biomarker. The prevalence of activated Notch1 in colorectal cancer is expected to be about 50 percent. Enrollment in the Phase 1b study is expected to commence in late 2016 or early 2017.

2016 Upcoming Milestones

Present first-in-human data for anti-DLL4/VEGF (OMP-305B83) and anti-RSPO3 (OMP-131R10) from ongoing Phase 1 trials at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium being held in Munich, Germany November 29-December 2, 2016.

File an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) before year-end for one of two immuno-oncology therapeutic candidates: IO#2, partnered with Celgene, or GITRL-Fc, a wholly owned OncoMed asset. A second IND application is expected to follow in the first half of 2017.
Third Quarter 2016 Financial Results

Cash, cash equivalents and short-term investments totaled $207.6 million as of September 30, 2016, compared to $171.5 million as of June 30, 2016. The company’s cash balance includes net proceeds of $59.2 million from a follow-on offering completed August 23, 2016.

Revenues for the three months ended September 30, 2016 were $5.9 million, an increase of $1.2 million, compared to total revenue of $4.7 million for the three months ended September 30, 2015. This increase was primarily due to amortization of the $70.0 million safety milestone achieved in the fourth quarter of 2015.

Research and development (R&D) expenses were $27.4 million for the third quarter of 2016 compared with $24.7 million for the same period in 2015. Higher R&D expenditures during the third quarter 2016 were attributable to increased manufacturing costs for the IO#2 and GITRL-Fc programs, increased clinical costs for the anti-RSPO3 and vantictumab programs and increased personnel costs. These increases were partially offset by a decrease in 2016 spending for the tarextumab program.

General and administrative (G&A) expenses were $4.5 million for the quarters ended September 30, 2016 and September 30, 2015. G&A costs during the third quarter 2016 increased due to personnel costs, offset by financing costs in the third quarter of 2015 related to the filing of the Form S-3 registration statement in June 2015.

Net loss for the third quarter 2016 was $25.9 million ($0.77 per share), compared to $24.5 million ($0.81 per share) for the same period of 2015. The change in net loss from the same quarter in 2015 was primarily attributable to an increase in research and development expenses.

On November 1, 2016 Genomic Health, Inc. (Nasdaq: GHDX) reported financial results and business progress for the quarter ended September 30, 2016 (Filing, Q3, Genomic Health, 2016, NOV 1, 2016, View Source [SID1234516158]).

Total revenue was $82.3 million in the third quarter of 2016, compared with $73.6 million in the third quarter of 2015, an increase of 12 percent.

U.S. product revenue was $70.0 million in the third quarter of 2016, an increase of 11 percent, compared with $63.0 million in the same period in the prior year. Prostate test revenue in the U.S. of $2.3 million contributed to approximately 3 percent of the year-over-year growth.

International product revenue was $12.1 million in the third quarter of 2016, compared with $10.5 million a year ago, an increase of 15 percent. International revenue on a constant currency basis increased by 18 percent compared with a year ago.(i)

In the third quarter, more than 29,990 Oncotype test results were delivered, an increase of 8 percent, compared with more than 27,820 test results delivered in the third quarter of 2015. U.S. invasive breast tests delivered grew 5 percent and prostate tests delivered grew 6 percent compared with the prior year. International tests delivered grew 15 percent compared with the prior year and represented approximately 24 percent of total test volume in the third quarter of 2016.

"In 2016 we have delivered three consecutive quarters of double-digit revenue growth, with 15 percent revenue growth and 12 percent test growth year-to-date, in line with our guidance provided in February," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "We believe these results demonstrate the strength of our business, including the importance of continuing to generate clinical data that differentiate our Oncotype IQ portfolio of products. Specifically, in invasive breast cancer, Oncotype DX remains the only genomic test proven to predict chemotherapy benefit and, with our latest clinical validation study in prostate cancer announced today, we now provide the only test to predict all major short- and long-term outcomes."

Operating loss for the third quarter of 2016 improved to $3.0 million, compared with $5.4 million for the third quarter of 2015. The operating loss includes a favorable impact in the quarter from the satisfaction of certain royalty payment obligations for the license of PCR patents, as well as an unfavorable impact from a write-down of a software development project for interactive digital reporting. These two items were approximately $2.5 million each and individually off-set each other.

Net loss was $2.8 million for the third quarter of 2016 compared with a net loss of $11.8 million for the third quarter of 2015. Basic and diluted net loss per share was $0.08 for the third quarter of 2016, compared with basic and diluted net loss per share of $0.36 for the same period in 2015.

Total revenue for the nine months ended September 30, 2016 was $245.1 million, compared with $212.3 million for the nine months ended September 30, 2015, an increase of 15 percent.

Operating loss improved to $16.9 million for the nine months ended September 30, 2016, compared with an operating loss of $30.9 million for the nine months ended September 30, 2015. Net loss was $15.3 million for the nine months ended September 30, 2016, compared with a net loss of $30.6 million for the nine months ended September 30, 2015.

Cash and cash equivalents and short-term marketable securities at September 30, 2016 were $83.6 million excluding the fair value of the company’s investment in a marketable security of $15.0 million, compared with $76.8 million at December 31, 2015 excluding the fair value of the company’s investment in a marketable security of $18.1 million.

Recent Business Highlights

Oncotype DX Commercial Progress

· As of September 30, 2016, the company’s flagship line of Oncotype DX gene expression tests has been used to guide treatment decisions for more than 700,000 cancer patients worldwide.
· Established an additional coverage for the Oncotype DX Genomic Prostate Score, bringing the total number of prostate cancer covered U.S. lives to more than 61 million.

Presentations and Publications

· Announced positive topline results from a prostate cancer clinical validation study demonstrating Oncotype DX is a strong predictor of the development of metastasis and prostate cancer death in patients with early-stage disease. With these new results, the Oncotype DX prostate cancer test becomes the first genomic test validated in all major short- and long-term end points, including adverse pathology, biochemical recurrence, metastasis and prostate cancer specific death.

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· Reviews in Urology published a comprehensive economic analysis demonstrating use of Oncotype DX in low-risk prostate cancer patients leads to an increase in a net uptake of active surveillance and a net savings of $2,286 per patient — including the cost of the test — by decreasing unnecessary immediate invasive treatment.

· Presented results from eight Oncotype DX Breast Recurrence Score presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress, highlighting superior clinical evidence in identifying which patients with node-negative and node-positive invasive breast cancer should be treated with chemotherapy. To date, the unique clinical utility of Oncotype DX has been demonstrated with prospective outcomes results in over 63,000 breast cancer patients.

· Presented robust analytical validation study results on Oncotype SEQ Liquid Select at the ESMO (Free ESMO Whitepaper) 2016 Congress. The results demonstrated that this liquid biopsy mutation panel is highly sensitive, specific and reproducible.

· Received acceptance to present seven studies at the 2016 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) in December.

On November 1, 2016 Xenetic Biosciences, Inc. (OTCQB: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported its common stock will begin trading on The Nasdaq Capital Market under the symbol "XBIO" on November 7, 2016 (Press release, Xenetic Biosciences, NOV 1, 2016, View Source [SID1234537811]). The Company also announced the pricing of its public offering of an aggregate of 2,424,242 units, consisting of (i) 484,849 units, consisting of one share of Convertible Series B Preferred Stock and a Class A Warrant to purchase one share of common stock and (ii) 1,939,393 units consisting of one share of Convertible Series B Preferred Stock and a Class B Warrant to purchase one share of common stock, at a public offering price of $4.125 per unit. The total expected gross proceeds of the public offering are approximately $10 million before the underwriter’s discount and expenses.

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In connection with its new listing on The Nasdaq Capital Market, November 4, 2016 will be the last day Xenetic’s common stock will trade on the OTCQB.

Ladenburg Thalmann & Co. Inc. acted as the sole book running manager for the offering.

The net proceeds from this offering will be used to fund the research and development of Xenetic’s product candidates, including Virexxa, as well as future development programs, potential in licensing of products or technology, capital expenditures, working capital, repayment of existing indebtedness, and other general corporate purposes.

The offering is expected to close on November 7, 2016, subject to customary closing conditions.

A registration statement on Form S-1 relating to the shares and warrants was filed with the Securities and Exchange Commission ("SEC") and has been declared effective. A preliminary prospectus relating to the offering has been filed with the SEC and is available on the SEC’s web site at View Source Copies of the final prospectus relating to the offering, when available, may be obtained from the offices of Ladenburg Thalmann & Co. Inc., 570 Lexington Avenue, 11th Floor, New York, NY 10022, telephone: (212) 409-2000 or email [email protected] or the above-referenced SEC website.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale is not permitted.

On October 31, 2016 DURECT Corporation (Nasdaq: DRRX) reported financial results for the third quarter of 2016. Total revenues were $3.7 million and net loss was $8.8 million for the three months ended September 30, 2016 as compared to total revenues of $4.7 million and net loss of $6.5 million for the three months ended September 30, 2015.
At September 30, 2016, we had cash and investments of $29.0 million, compared to cash and investments of $29.3 million at December 31, 2015. At September 30, 2016, we had $19.8 million in long term debt.
"We are pleased to have provided a separate update today on our DUR-928 program," stated James E. Brown, D.V.M., President and CEO of DURECT. "Regarding POSIMIR, we have switched over the majority of our active clinical trial sites in the PERSIST Phase 3 trial from Part 1 to Part 2, in which POSIMIR is compared head-to-head against bupivacaine HCL, and continue to add new sites as enrollment proceeds."
Update of Selected Programs:

• Epigenetic Regulator Program. DUR-928, our Epigenetic Regulator Program’s lead product candidate, is an endogenous, small molecule, new chemical entity (NCE), which may have broad applicability in several metabolic diseases such as nonalcoholic steatohepatitis (NASH), and in acute organ injuries such as acute kidney injury.
As reported in greater detail in a separate press release today, our first Phase 1b clinical trial in patients has progressed to the second cohort with a higher dose. While this study was not designed to assess the efficacy of DUR-928 as a therapy for NASH, we are pleased to be able to report that certain biomarkers for liver function and liver injury were reduced in the first cohort 12 hours after a single dose of DUR-928 as compared to before dosing. Collectively, the reduction of these biomarkers plus results from our animal and cell culture studies suggest potential therapeutic activity of DUR-928 for patients with liver disease. However, additional studies are required to evaluate the safety and efficacy of DUR-928, and there is no assurance that these biomarker effects will be observed in a statistically significant manner, or that DUR-928 will demonstrate safety or efficacy in treating NASH or other liver diseases in larger controlled trials. We have recently requested a pre-IND meeting with the U.S. Food and Drug Administration (FDA) as precursor to submitting an IND, which is required to enable a future liver disease clinical trial in the United States.
Our second Phase 1b clinical study with DUR-928, in patients with impaired kidney function (stage 3 and 4 chronic kidney disease), is underway in Australia. We recently held a pre-IND meeting with the Cardiovascular and Renal Products Division of the FDA; we anticipate utilizing feedback from that meeting as well as from our clinical advisors to file an IND which is required to enable a future kidney disease clinical trial in the United States.
• POSIMIR (SABER-Bupivacaine) Post-Operative Pain Relief Depot. POSIMIR is our investigational post-operative pain relief depot that utilizes our patented SABER technology and is intended to deliver bupivacaine to provide up to 3 days of pain relief after surgery. We are in discussions with potential partners regarding licensing development and commercialization rights to POSIMIR, for which we hold worldwide rights. We are also continuing to evaluate the requirements for commercializing POSIMIR on our own in the U.S., in the event that we determine that to be the preferred route of commercialization.
In November 2015, we began enrolling patients for PERSIST, a POSIMIR Phase 3 clinical trial consisting of patients undergoing laparoscopic cholecystectomy (gallbladder removal) surgery. We began recruiting patients for this trial comparing POSIMIR to placebo. Based on recommendations from the FDA received subsequent to the start of the trial, in April 2016 we decided to amend the PERSIST trial. Starting in August 2016, we began implementing Part 2 of the PERSIST trial to evaluate POSIMIR against standard bupivacaine HCl rather than placebo as we have been doing in Part 1. We expect to enroll approximately 264 patients in Part 2 of PERSIST, and we expect this part of the trial to finish dosing patients in the third quarter of 2017. We believe that a positive outcome from this new trial design would result in a stronger NDA resubmission and potential commercial advantages. In a previous clinical trial of 50 patients in the same surgical model (laparoscopic cholecystectomy), POSIMIR was compared with the active control bupivacaine HCl, against which POSIMIR demonstrated in a post hoc analysis an approximately 25% reduction in pain intensity on movement for the first 3 days after surgery (p=0.024) and for the first 2 days after surgery (p=0.0198), using the same statistical methodology specified for the current trial. There can be no assurance that the PERSIST trial will replicate these results.

• REMOXY ER (oxycodone) Extended-Release Capsules CII. Based on our ORADUR technology, the investigational drug REMOXY ER is a unique long-acting formulation of oxycodone designed to discourage common methods of tampering associated with opioid misuse and abuse.
In September 2016, Pain Therapeutics (our licensee) received a Complete Response Letter from the FDA for REMOXY ER. Based on its review, the FDA has determined that the NDA cannot be approved in its present form and specifies additional actions and data that are needed for drug approval. Pain Therapeutics has stated that it is evaluating the comments raised by the FDA and is consulting with outside experts.

• ORADUR-ADHD Program. ORADUR-Methylphenidate is an investigational drug that has the potential for rapid onset of action, long duration with once-a-day dosing, utilizes a small capsule size relative to the leading existing long-acting products on the market and incorporates our ORADUR anti-tampering technology. Orient Pharma, our licensee in defined Asian and South Pacific countries, has initiated a Phase 3 study in Taiwan and anticipates completing dosing the trial in 2016. We retain rights to all other markets in the world, notably including the U.S., Europe and Japan, and are engaged in licensing discussions with other companies.
• Business Development Activities. We have multiple programs that may potentially be licensed over the next 12-18 months. These include POSIMIR, DUR-928, ORADUR-ADHD (territories outside certain Asian and South Pacific markets), as well as various other programs which we have not described publicly in detail.

• Debt Refinancing. In July 2016, we refinanced our existing $20 million term loan with Oxford Finance into a new term loan that results in an extended maturity (to four years) and an extended interest only period (to 18 months).

• Upcoming investor conference. DURECT will be presenting at the Stifel Nicolaus Healthcare Conference at 4:30 pm Eastern time on November 15. The conference is being held at the New York Palace Hotel in New York. A live audio webcast of the presentation will be available by accessing View Source A live audio webcast of these presentations will also be available by accessing DURECT’s homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under Audio Archive in the "Investor Relations" section.

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On October 31, 2016 ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("ProMetic" or the "Corporation") reported today that it has closed the acquisition of all the issued and outstanding common shares of Telesta Therapeutics, Inc, ("Telesta") by way of a plan of arrangement under the Canada Business Corporations Act (the "Acquisition") for a consideration of $0.14 per Telesta common share payable in ProMetic common shares (Press release, ProMetic Life Sciences, OCT 31, 2016, View Source [SID1234516121]).

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The number of common shares to be issued by ProMetic is based on the volume-weighted average closing price ("VWAP") of ProMetic’s common shares for the five (5) trading days prior to the closing date of the Acquisition. At the end of trading on the Toronto Stock Exchange on Friday, October 28, 2016, the 5 day VWAP of ProMetic’s common shares was $2.98. Accordingly, each Telesta common share was acquired for 0.04698 ProMetic common share.

Pierre Laurin, President and CEO of ProMetic stated: "We welcome Telesta’s shareholders decision to participate to ProMetic’s growth as they will benefit from our ability to further leverage Telesta’s assets. ProMetic represents a balanced, low-risk, high reward opportunity as we are getting ready to launch our first plasma-derived therapeutic, plasminogen, in mid-2017 followed by the sequential launches of several other plasma-derived products from our proprietary manufacturing platform. Furthermore, our small molecule fibrosis program is set to contribute further significant upside now that PBI-4050’s efficacy in humans has been demonstrated", added Mr. Laurin.

"Closing this transaction is both strategically and tactically significant for ProMetic for many reasons", commented Bruce Pritchard, Chief Operating Officer. He added, "It brings cash which extends our operating runway; a small group of key personnel who are highly complementary to our existing staff; tax losses to be used going forward; and lastly, a facility located in Belleville, Ontario with a recently refurbished part that could add quickly to our existing manufacturing output and in the longer term, the potential to provide additional plasma processing capacity. It also widens our trans-Canadian footprint, positioning us as a major supplier of plasma proteins to the Canadian market".

Concurrently with the Acquisition, the Corporation has closed a private placement entered into with Structured Alpha LP ("SALP"), an investment vehicle of Peter J. Thomson. This concurrent private placement was completed in connection with the exercise by SALP of its pre-emptive right. The private placement is for the subscription of 1,401,632 common shares of the Corporation at a price of $2.98 per common share. The proceeds from this private placement have been used to offset and reduce the total amount owed by ProMetic to SALP under its second amended and restated loan agreement by $4,176,863.36.