On August 14, 2018 CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that management will participate in upcoming investor conferences, including the Wedbush PacGrow Healthcare Conference, the H.C. Wainwright 20th Annual Global Investment Conference, and the Citi’s 13th Annual Biotech Conference (Press release, CymaBay Therapeutics, AUG 14, 2018, View Source [SID1234528922]).

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Wedbush PacGrow Healthcare Conference
Date: Wednesday, August 15
Time: 2:30pm Eastern Time
Location: Parker New York, New York, NY
Webcast: View Source

H.C. Wainwright 20th Annual Global Investment Conference
Date: Wednesday, September 5
Time: 9:10am Eastern Time
Location: St. Regis Hotel, New York, NY
Webcast: View Source

Citi’s 13th Annual Biotech Conference
Date: Thursday, September 6
Time: 1-on-1 meetings only
Location: Four Seasons Hotel, Boston, MA

On August 14, 2018 Prometic Life Sciences Inc. (TSX: PLI, OTCQX: PFSCF) (Prometic or the Corporation) reported today its unaudited financial results for the second quarter ended June 30, 2018 (Press release, ProMetic Life Sciences, AUG 14, 2018, View Source [SID1234528885]).

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"During the second quarter, the corporation made significant progress advancing its corporate action plan that was introduced during the annual shareholders meeting in May 2018," said Pierre Laurin, President and Chief Executive Officer of Prometic. "Notably, Prometic submitted its plan to the FDA regarding the design and implementation of the required additional in-process controls and assays related to its RyplazimTM (plasminogen) Biologics License Application (BLA). The FDA’s feedback following a review meeting in September will be used to confirm the remaining work to be completed and the associated timelines. We remain committed and focused to gaining the FDA’s approval of RyplazimTM (plasminogen). We continue our PBI-4050 and RyplazimTM (plasminogen) discussions with interested parties in order to conclude partnerships that will provide us with greater financial and operational flexibility. Finally, we met with the FDA today to discuss the regulatory pathway for our anti-fibrotic drug candidate, PBI-4050, for the treatment of Alström syndrome, for which we recently received a Rare Pediatric Disease Designation."

Commenting on the second quarter 2018 financial results, Bruce Pritchard, Prometic’s Chief Operating Officer and Chief Financial Officer, said, "During the second quarter of 2018, we generated $14.0 million of cash from the sale of plasma inventory. We used $44.9 million to fund operations through the first half of the year and remain comfortable with the full-year operating cash usage guidance that we provided at the annual shareholders meeting in May. Also, as previously mentioned, we are actively pursuing multiple initiatives to strengthen our balance sheet and extend our cash runway through value-creating milestones. In the meantime, we will continue to carefully manage our resources and control our costs."

Corporate Highlights

Appointed Mr. Bruce Wendel as Chief Business Development Officer

Small Molecule Therapeutics Highlights

PBI-4050 – Presented new clinical data at the International Liver Congress 2018 suggesting positive clinical activity observed in Alström patients with signs of improved liver function and reduced fibrosis in fat tissues
PBI-4050 – Presented new clinical data at the American Thoracic Society 2018 conference suggesting positive clinical activity was observed on blood biomarkers known to have anti-fibrotic activity
PBI-4547 – Presented new pre-clinical data at the American Diabetes Association scientific sessions suggesting the potential activity of PBI-4547 offers the potential to successfully address significant unmet medical needs in liver fibrosis, nonalcoholic steatohepatitis, nonalcoholic fatty liver disease, obesity and diabetes

Plasma-Derived Therapeutics Highlights

RyplazimTM (Plasminogen) – Submitted plan to FDA regarding the list of items outlined by the FDA, the design and implementation of required additional in-process controls and assays related to the Company’s RyplazimTM (plasminogen) BLA
IVIG – Achieved clinical primary and secondary endpoints in a pivotal phase 3 trial that also demonstrated safety and efficacy data comparable to existing commercial IVIG products, with no significant drug related safety issues.

2018 Second Quarter Financial Results

Revenues

Total revenues for the second quarter ended June 30, 2018 were $20.2 million compared to $3.6 million for the second quarter ended June 30, 2017. Total revenues for the six months ended June 30, 2018 were $24.4 million compared to $8.5 million for the comparable period in 2017. The increase was largely driven by $14.0 million from the sale of plasma inventory in the second quarter ended June 30, 2018. Due to the change in the production forecast resulting from the delay of the Ryplazim (plasminogen) BLA approval, the Corporation opted to sell this inventory and utilize the cash proceeds in its operations. Third party revenues from the sale of bioseparation products totaled $5.7 million for the second quarter ended June 30, 2018, compared to $2.9 million for the quarter ended June 30, 2017. Third party revenues from the sale of bioseparation products amounted to $9.4 million for the six months ended June 30, 2018, compared to $7.0 million for the six months ended June 30, 2017.

Cost of sales and other production expenses

Cost of sales and other production expenses were $16.4 million for the second quarter ended June 30, 2018 compared to $1.6 million for the corresponding period in 2017, representing an increase of $14.9 million. Cost of sales and other production expenses were $21.2 million during the six months ended June 30, 2018 compared to $3.9 million for the corresponding period in 2017, representing an increase of $17.2 million. The increase was due primarily to the cost of the plasma inventory sold of $15.5 million.

Research and Development (R&D)

Total R&D expenses were $24.0 million for the second quarter ended June 30, 2018 compared to $24.5 million for the second quarter ended June 30, 2017. Total R&D expenses were $46.4 million for the six months ended June 30, 2018 compared to $48.9 million for the corresponding period in 2017, representing a decrease of $2.5 million.

Administration, Sales & Marketing

Administration, selling and marketing expenses were $6.9 million for the second quarter ended June 30, 2018 compared to $8.1 million for the second quarter ended June 30, 2017. The $1.1 million decrease was due to a reduction in consulting fees and employee compensation expenses. Administration, selling and marketing expenses declined slightly to $14.6 million during the six months ended June 30, 2018 compared to $15.0 million for the corresponding period in 2017.

Finance Costs

Finance costs were $5.3 million for the second quarter ended June 30, 2018 compared to $1.9 million during the corresponding period of 2017, representing an increase of $3.5 million. Finance costs were $9.6 million for the six months ended June 30, 2018 compared to $3.2 million during the corresponding period of 2017, representing an increase of $6.3 million. This increase reflects higher debt levels during the six months ended June 30, 2018 compared to the same period of 2017 and the higher cost of borrowing on the non-revolving credit facility.

Net Loss

Prometic incurred a net loss of $33.1 million for the second quarter ended June 30, 2018 compared to a net loss of $31.5 million for the second quarter ended June 30, 2017. Prometic incurred a net loss of $67.7 million for the six months ended June 30, 2018 compared to a net loss of $60.6 million for the corresponding period of 2017. The net loss for the first six months of 2018 includes financing costs of $9.6 million as well as the write-down of $1.5 million of inventory. This increase in net loss was partially offset by a $2.5 million decrease in R&D during the first six months of 2018 as compared to the corresponding period in 2017.

Conference Call Information

Prometic will host a conference call at 11:00 am (ET) on Wednesday August 15, 2018. The telephone numbers to access the conference call are (647) 427-7450 and 1-888-231-8191 (toll-free). A replay of the call will be available as of Wednesday August 15, 2018 at 2:00 pm. The numbers to access the replay are 1-416-849-0833 and 1-855-859-2056 (passcode: 9986217). A live audio webcast of the conference call, with slides, will be available through the following: View Source

Additional Information in Respect to the Second Quarter Ended June 30, 2018

Prometic’s MD&A and condensed interim consolidated financial statements for the quarter ended June 30, 2018 will be filed on SEDAR (View Source) and will be available on the Company’s website at www.prometic.com.

On August 14, 2018 Sesen Bio, Inc. (NASDAQ: SESN), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, reported pipeline updates and operating results for the second quarter ended June 30, 2018 (Press release, Eleven Biotherapeutics, AUG 14, 2018, View Source [SID1234528923]).

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"The first half of 2018 was full of successful milestones for Sesen Bio, and I am excited to have joined the company at such an important time in its evolution," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio, who was recently appointed on August 7, 2018. "The three-month data from the Phase 3 VISTA Trial demonstrate a strong complete response rate and favorable safety with Vicinium for high-grade non-muscle invasive bladder cancer, and we look forward to assessing twelve-month efficacy data in less than a year’s time. Now, with Fast Track designation for Vicinium, we are focused on advancing our engagement with the FDA, kicking off critical manufacturing readiness activities, initiating pre-commercial efforts and preparing for our very first BLA submission for Vicinium for this highly deserving patient population. I am very confident in what the future holds for Sesen Bio and look forward to delivering on the important milestones we have ahead."

Business Update

In June 2018, Sesen Bio completed an underwritten public offering of its common stock raising gross proceeds of approximately $46 million. The company believes this financing extends the company’s cash runway into 2020 based on its current operating plan.
Vicinium Program Updates

In August 2018, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to Vicinium for the treatment of BCG-unresponsive, high-grade non-muscle invasive bladder cancer (NMIBC). Fast Track designation is intended to expedite the development and review process of therapeutics that address unmet medical needs, including opportunities for more frequent interactions with the FDA.
In June 2018, the National Cancer Institute (NCI) initiated patient dosing in the Phase 1 trial of Vicinium in combination with AstraZeneca’s PD-L1 checkpoint inhibitor, Imfinzi (durvalumab). The NCI is evaluating the combination under a Cooperative Research and Development Agreement, which was executed in June 2017.
In May 2018, Sesen Bio presented positive, three-month data from its ongoing Phase 3 VISTA Trial of Vicinium for the treatment of patients with high-grade NMIBC who have been previously treated with bacillus Calmette-Guérin (BCG), during a plenary session at the American Urological Association Annual Meeting.
In the cohort of patients with carcinoma in situ (CIS) with or without papillary disease whose cancer recurred within six months of their last course of BCG treatment, treatment with Vicinium demonstrated a complete response rate of 39 percent. In evaluable patients in the cohort of patients with CIS with or without papillary disease whose cancer recurred after six months, but before 11 months, after their last course of BCG treatment, treatment with Vicinium demonstrated a complete response rate of 80 percent. This translates into a 42 percent complete response rate for the combined cohorts of CIS patients who were BCG-unresponsive within 12 months of their last BCG treatment.
In patients with papillary disease without CIS whose cancer recurred within six months of their last course of BCG treatment, treatment with Vicinium demonstrated a 68 percent recurrence-free rate at three months.
To date, Vicinium has been well-tolerated by patients in the VISTA Trial. Sesen Bio anticipates reporting twelve-month data from its Phase 3 VISTA Trial in mid-2019.
Second Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents were $62.9 million as of June 30, 2018, compared to $15.8 for the same period in 2017.
R&D Expenses: Research and development expenses were $2.8 million for the quarter ended June 30, 2018, compared to $2.9 million for the same period in 2017. This decrease was due primarily to a reduction in Vicinium-related development expenses.
G&A Expenses: General and administrative expenses were $2.4 million for the quarter ended June 30, 2018, compared to $2.2 million for the same period in 2017. This increase was due primarily to an increase in professional fees.
Net Loss: Net loss was $9.0 million, or $0.16 per share, for the quarter ended June 30, 2018, compared to net loss of $7.3 million, or $0.30 per share, for the same period in 2017.
Financial Guidance: Following the company’s public offering in June 2018, Sesen Bio believes it will have capital sufficient to fund its current operating plans into 2020.
About the VISTA Clinical Trial
The VISTA Trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicinium in patients with high-grade non-muscle invasive bladder cancer (NMIBC) that is carcinoma in situ (CIS), which is cancer found on the inner lining of the bladder that has not spread into muscle or other tissue) and/or papillary, which is cancer that has grown from the bladder lining out into the bladder but has not spread into muscle or other tissue, who have been previously treated with bacillus Calmette-Guérin (BCG). The primary endpoint of the trial is the complete response rate in patients with CIS with or without papillary disease. Patients in the trial receive locally administered Vicinium twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years. Twelve-month data are anticipated in mid-2019. To learn more about the Phase 3 VISTA Trial, please visit www.clinicaltrials.gov and search the identifier NCT02449239.

About Vicinium
Vicinium, also known as VB4-845, is Sesen Bio’s lead product candidate and is a next-generation antibody-drug conjugate (ADC), developed using the company’s proprietary Targeted Protein Therapeutics platform, for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A (ETA). Vicinium is constructed with a stable, genetically engineered peptide linker to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA Trial, designed to support the registration of Vicinium for the treatment of high-grade NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Twelve-month data from the trial are anticipated in mid-2019. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On August 13, 2018 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN) ("Diffusion" or "the Company"), a clinical-stage biotechnology company focused on improving patient outcomes in unmet medical needs using its novel small molecule trans sodium crocetinate (TSC), reported its financial results for the three months ended June 30, 2018 and provides a business update (Press release, Diffusion Pharmaceuticals, AUG 13, 2018, View Source [SID1234529170]).

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Commenting on the second quarter, David Kalergis, Chairman and Chief Executive Officer, said, "We have continued to screen and enroll patients with inoperable glioblastoma multiforme (GBM) into our INTACT Phase 3 pivotal trial. Following the dose escalation run-in portion, this planned 236-patient study will enroll half the patients in the treatment arm consisting of standard-of-care radiation and chemotherapy plus TSC, and half in the control arm, which is standard-of-care alone. We designed INTACT based on our Phase 2 study that demonstrated a nearly four-fold increase in overall survival at two years in inoperable GBM patients."

Mr. Kalergis continued, "During the quarter, U.S. Patent 9,950,067 issued relating to methods of treating cancer using bipolar trans carotenoids including TSC. European patent 2575487 was validated for oral formulations of bipolar trans carotenoids and includes novel compositions in tablet, pill or capsule form. Further, US Patent 10,016,384, also relating to oral formulations of bipolar trans carotenoids, issued on July 10, 2018. We believe TSC holds great promise in treating a number of diseases in addition to cancer and are pleased to be able to protect a patient-friendly oral formulation suitable for more chronic uses. Our intellectual property protection further supports the value of TSC as we discuss partnership opportunities in various indications and geographies."

Diffusion is continuing preparations for a Phase 2 randomized, double-blind, placebo-controlled trial with TSC in acute stroke in cooperation with UCLA and the University of Virginia, and is in discussions with potential partners. Financing permitting, we expect to begin enrolling patients in early 2019 with data in about 18 months thereafter. The study calls for the administration of TSC by specially-trained Emergency Medical Technicians to ambulance-transported patients within two hours of the onset of a suspected acute stroke. In-ambulance administration could overcome the current severe timing delay in administering therapy to stroke victims, serving a market of up to 800,000 patients a year who suffer acute stroke.

Financial Results for the Three Months Ended June 30, 2018

We had cash and cash equivalents of $12.9 million as of June 30, 2018. We believe that our cash and cash equivalents will enable us to fund our obligated operating expenses and capital expenditure requirements into September 2019.

We recognized $1.4 million in research and development expenses during the three months ended June 30, 2018, compared with $1.2 million during the three months ended June 30, 2017. The increase was mainly attributable to a $0.8 million increase in expenses related to our Phase 3 GBM trial, offset by a $0.6 million decrease in expense associated with manufacturing costs.

General and administrative expenses for the three months ended June 30, 2018 were $1.7 million, compared with $1.8 million for the three months ended June 30, 2017. The decrease in general and administrative expense was primarily due to a $0.3 million decrease in professional fees, partially offset by an increase in salary and wages expense of $0.2 million.

Net cash used in operating activities for the first half of 2018 was $5.8 million, compared with $6.2 million during the same period in the prior year.

On August 13, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) for ELZONRISTM (tagraxofusp; SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, Stemline Therapeutics, AUG 13, 2018, View Source [SID1234532233]). The FDA also granted Priority Review for the BLA and has set a target action date of February 21, 2019, under the Prescription Drug User Fee Act (PDUFA).

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The FDA grants Priority Review to product applications that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

ELZONRIS has also been granted Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) by the FDA.

Ivan Bergstein, M.D., Stemline’s CEO, commented, "The acceptance of our BLA for filing and grant of Priority Review represent tremendous milestones for Stemline and the BPDCN patient community. We would like to thank the patients and their families who participated in our clinical trials, as well as recognize the tireless work of our investigators and entire Stemline team. Given both Priority and Breakthrough status, our commercial organization is positioning itself to rapidly launch ELZONRIS, if approved, to ensure this important new treatment reaches patients as quickly as possible."

Conference Call and Webcast
Stemline Therapeutics will host a conference call and audio webcast on Monday, August 13, 2018 at 8:30 AM ET. Interested participants and investors may access the conference call by dialing 844-389-8660 (U.S./Canada) or 478-219-0408 (International) and referencing conference ID: 4762319. An audio webcast can also be accessed via the Investor Relations tab of the Stemline Therapeutics website at View Source

About ELZONRISTM (tagraxofusp; SL-401)
ELZONRISTM (tagraxofusp; SL-401) is a novel targeted investigational therapy directed to CD123, a cell surface receptor expressed on a range of malignancies. ELZONRIS successfully completed a pivotal trial in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), and a Biologics License Application (BLA) in this indication has been accepted for filing and been granted Priority Review by the U.S. Food and Drug Administration (FDA). ELZONRIS has also been granted Breakthrough Therapy Designation (BTD) and Orphan Drug Designation by the FDA. ELZONRIS is also being evaluated in clinical trials in additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and others.