On May 15, 2017 Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a late stage clinical biopharmaceutical company developing topsalysin (PRX302) for the treatment of patients with urological diseases, today reported first quarter financial results and key corporate highlights (Press release, Sophiris Bio, MAY 15, 2017, View Source [SID1234519162]).

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Key Corporate Highlights:

Update on Phase 2b Localized Prostate Cancer Study. In March 2017, the Company initiated its Phase 2b open-label localized prostate cancer study with investigational sites in both the UK and US. Five clinical trial sites have been initiated and additional sites are in the process of being initiated.

The Company is currently awaiting final regulatory clearance for the diluent (the medium in which topsalysin is diluted prior to dosing), which is anticipated this month, at which point the investigational sites will begin dosing patients.

The Company expects to receive the six-month biopsy data for all patients in the first quarter of 2018 assuming enrollment is completed as expected. The Company expects to have complete data on all patients who receive a second dose by the fourth quarter of 2018.

Presented Proof-of-Concept and Phase 2a Data at Global Urological Meetings. The Company presented positive data from its Phase 2a clinical trial of topsalysin for the focal treatment of localized prostate cancer at the 112th American Urological Association Annual Meeting and at the 32nd European Association of Urology Congress. Copies of the posters are available on the Company’s website at www.sophirisbio.com.

“We now have five clinical trial sites fully trained with additional sites coming onboard,” said Randall E. Woods, president and CEO of Sophiris. “The regulatory approval of the diluent is the last remaining box to check in the administrative work that enables the dosing of patients which we anticipate being able to do in the very near future.”

Financial Results:

At March 31, 2017, the Company had cash, cash equivalents and securities available-for-sale of $25.7 million and working capital of $25.6 million. The Company expects that its cash and cash equivalents will be sufficient to fund its operations through the end of 2018. The Company is currently not planning on pursuing a second Phase 3 trial in BPH, unless the Company can secure a development partner to fund a new clinical trial or the Company obtains other financing.

The Company reported a net loss of $2.6 million ($0.09 per share) for the three months ended March 31, 2017 compared to a net loss of $2.2 million ($0.13 per share) for the three months ended March 31, 2016.

Research and development expenses were $1.2 million for the three months ended March 31, 2017, compared to $0.9 million for the three months ended March 31, 2016. The increase in research and development expenses was primarily attributable to an increase in the costs associated with the Company’s on-going Phase 2b clinical trial for the focal treatment of localized prostate cancer which was initiated in March 2017 and, to a lesser extent, an increase in costs associated with manufacturing activities for topsalysin. These increases were partially offset by a decrease in costs associated with our completed Phase 2a proof of concept clinical trial for low to intermediate risk prostate cancer.

General and administrative expenses were $1.4 million for the three months ended March 31, 2017 compared to $1.2 million for the three months ended March 31, 2016. The increase in general and administrative expenses was primarily due to an increase in non-cash stock-based compensation expense which was offset by a reduction in legal and professional services.

On May 15, 2017 Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection reported financial results for the three months ended March 31, 2017 (Press release, Aeolus, MAY 15, 2017, View Source [SID1234519167]).

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The company reported net loss of $1,035,000 or $0.01 per share for the three months ended March 31, 2017. This compares to a net loss (before extraordinary items) of $629,000 or $0.01 per share for the three months ended March 31, 2016. The increase in net loss was primarily attributable to pre-IND work on AEOL 11114, the Company’s compound in development for the treatment of Parkinson’s disease and lower revenues from the Biomedical Advanced Research and Development Authority ("BARDA").

"During the quarter, we initiated a Phase 1 safety study of AEOL 10150 in healthy volunteers, completed manufacturing optimization and oral formulation development work on AEOL 11114 for Parkinson’s disease, and reported positive results in an animal model of Cystic Fibrosis with inhaled AEOL 20415," stated John L. McManus, President and Chief Executive Officer. "Although we were disappointed with BARDA’s notification in March that it had elected not to exercise additional options under the contract at this time, we are continuing work in process under the contract through its expiration in May 2019. In addition, we are submitting proposals to and have received indications of interest from other government agencies to expand the funding of AEOL 10150 as a medical countermeasure against the pulmonary effects of radiation exposure and sulfur mustard gas exposure."

Results of Operations for the Three Months Ended March 31, 2017

Revenue for the three months ended March 31, 2017 was $129,000, which compares to $565,000 for the three months ended March 31, 2016. The revenue is from the BARDA Contract and the decline in revenue is primarily attributable to a lower level of activity under that contract.

Research and Development ("R&D") expenses increased $93,000, or 19%, to $594,000 for the three months ended March 31, 2017 from $501,000 for the three months ended March 31, 2016. The increase is primarily attributable to manufacturing optimization and oral formulation development work for AEOL 11114.

General and administrative ("G&A") expenses decreased $123,000, or 18%, to $570,000 for the three months ended March 31, 2017 from $693,000 for the three months ended March 31, 2016. The decrease is primarily attributable to lower accounting and legal fees related to SEC filing requirements.

Results of Operations for the Six Months Ended March 31, 2017

Revenue for the six months ended March 31, 2017 was $212,000, which compares to $870,000 for the six months ended March 31, 2016. The revenue is from the BARDA Contract and the decline in revenue is primarily attributable to a lower level of activity under that contract.

Research and Development ("R&D") expenses increased $89,000, or 9%, to $1,082,000 for the six months ended March 31, 2017 from $993,000 for the six months ended March 31, 2016. The increase is primarily attributable to manufacturing optimization and oral formulation development work for AEOL 11114.

General and administrative ("G&A") expenses decreased $2,000 to $1,252,000 for the six months ended March 31, 2017 from $1,254,000 for the six months ended March 31, 2016. The decrease is primarily attributable to lower investor relations fees.

As of March 31, 2017, the Company had approximately $981,000 in cash and cash equivalents and 152,085,825 common shares outstanding. The Company had accounts receivable of $603,000 and accounts payable of $638,000 on March 31, 2017.

Aeolus has filed today with the SEC its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. Aeolus urges its investors to read this quarterly filing as well as its Annual Report on Form 10-K, also filed with the SEC, for further details concerning the Company. The Quarterly Report on Form 10-Q and the Annual Report on Form 10-K are also available on the Company’s website, at www.aolsrx.com.

About AEOL 10150

AEOL 10150 is a superoxide dismutase (SOD) mimic being developed for the treatment/mitigation of lung damage from exposure to chemical and radiological insults and to reduce/prevent lung damage in patients with Idiopathic Pulmonary Fibrosis (IPF) and in cancer patients receiving radiation therapy. AEOL 10150 protects tissue from damage and increases survival in animal models of lung damage after exposure to radiation toxic chemicals, agents that induce inflammation, and trauma by mitigating and/or preventing cell death, inflammation and fibrosis through its action on oxidative stress (Reactive Oxygen Species, or "ROS") and regulation of growth factors and chemokines including PTEN, TGF-β1, HIF-1α, TNF-α and IL-6, as well as impacting subsequent signaling pathways associated with ROS production, apoptosis and fibrosis such as NADPH-oxidase (Nox-4), PTEN, PI3K/p-Akt and p53/Bax. AEOL 10150 has been shown to improve survival and mitigate pulmonary damage in rodent models of SMG, chlorine gas and radiation exposure and in a nonhuman primate (NHP) model of whole thorax lung irradiation (WTLI). Given these promising results, Aeolus is developing AEOL10150 for the mitigation and/or treatment of pulmonary injury resulting from SMG exposure.

AEOL 10150 has performed well in animal safety studies, was well tolerated in two human clinical trials and is currently being tested in a third human study. Aeolus has received "Orphan Drug" designation for use in treating Lung ARS, Idiopathic Pulmonary Fibrosis and Amyotrophic Lateral Sclerosis and has active IND’s for the Lung ARS and ALS indications. Preparations are currently underway to make IND filings for Idiopathic Pulmonary Fibrosis, Cancer Radiation Therapy and Pulmonary Effects of Sulfur Mustard Gas Exposure.

On May 15, 2017 Threshold Pharmaceuticals, Inc. (Nasdaq:THLD) reported financial results for the first quarter ended March 31, 2017, and provided an update on the Company’s corporate and clinical development activities (Filing, Q1, Threshold Pharmaceuticals, 2017, MAY 15, 2017, View Source [SID1234519164]).

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"With our recently announced proposed merger between Threshold and Molecular Templates and execution of our clinical trial agreement with the MD Anderson Cancer Center, we are well positioned to advance our lead product candidate, evofosfamide, into the Phase 1 clinical trial at the MD Anderson Cancer Center in the second quarter 2017," said Barry Selick, Ph.D., Threshold’s Chairman of the Board.

Recent Highlights

Definitive Merger Agreement
Threshold announced on March 17, 2017 that it had entered into a definitive agreement under which Molecular Templates will merge with a wholly owned subsidiary of Threshold in an all-stock transaction. The transaction will result in a combined company focused on the development of novel treatments for cancer. Longitude Capital, a U.S. based venture capital firm, will invest $20 million after the close of the transaction, subject to certain conditions, including the receipt of additional equity financing commitments of an additional $20 million. The transaction has been approved by the board of directors of both companies and is expected to close in the second quarter of 2017, subject to the approval of the stockholders of each company as well as other customary conditions. Highlights of the merger include:

· Upon closing of the transaction, Threshold will change its name to Molecular Templates, Inc. and plans to change its ticker symbol on the Nasdaq Capital Market to MTEM.
· On a pro forma basis and based upon the number of shares of common stock to be issued in the merger, current Threshold shareholders would own approximately 34.4 percent of the combined company and current Molecular Templates shareholders will own approximately 65.6 percent of the combined company although the actual allocation will be subject to adjustment based on Threshold’s net cash balance.
· Eric Poma, Ph.D., Chief Executive Officer of Molecular Templates, will become Chief Executive Officer of the combined company.
· Following the merger, the board of directors of the combined company will consist of seven seats and will be comprised of two representatives from Molecular Templates, two representatives from Threshold, and three representatives to be mutually agreed upon by Molecular Templates and Threshold. The Company’s current chairman of the board of directors, Barry Selick, Ph.D., will become chairman of the board of the combined company following the merger.

Evofosfamide
Threshold’s lead product candidate is an investigational hypoxia-activated prodrug that is designed to be activated under tumor hypoxic conditions, a hallmark of many cancers. Recent updates include:

• The Company is on track to commence its Phase 1 clinical trial evaluating evofosfamide in combination with the immune checkpoint antibody, ipilumumab, by mid-2017 at the MD Anderson Cancer Center in Houston to potentially improve the efficacy of immune checkpoint antibody as an anti-cancer therapy.


Threshold Pharmaceuticals

First Quarter 2017 Financial Results
· Cash, cash equivalents and marketable securities totaled $17.6 million at March 31, 2017 compared to $23.6 million at December 31, 2016. The net decrease of $6.0 million was a result of $4.0 million for operating cash requirements for the quarter ended March 31, 2017 and a $2.0 million bridge loan to Molecular Templates, Inc. in the form of a promissory note.

· Research and development expenses were $1.6 million for the first quarter ended March 31, 2017, compared to $6.0 million for the same period in 2016. The $4.4 decrease in research and development expenses, net of reimbursement for Merck KGaA, Darmstadt, Germany’s 70 percent share of total eligible collaboration expenses for evofosfamide, was due primarily to a $0.9 million decrease in employee related expenses, including a $0.2 million decrease in non-cash stock-based compensation expense and a $3.5 million decrease in clinical development expenses and consulting expenses.

· General and administrative expenses were $2.9 million for the first quarter ended March 31, 2017 compared to $2.2 million for the same period in 2016. The $0.7 increase in general and administrative expenses was due to a $0.9 million increase in consulting expenses partially offset by a $0.2 million decrease in employee related expenses.

· Non-cash stock-based compensation expense included in total operating expenses was $0.5 million for the first quarter ended March 31, 2017 compared to $0.8 million for the same period in 2016. The decrease in stock-based compensation expense was due to the amortization of a smaller number of options with lower fair values.

· Net loss for the first quarter ended March 31, 2017 was $5.1 million compared to $7.9 million for the same period in 2016. Included in the net loss for the first quarter of 2017 was an operating loss of $4.4 million and non-cash expense of $0.7 million compared to an operating loss of $8.3 million and non-cash income of $0.4 million for the first quarter of 2016.

About Evofosfamide
Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug of a bis-alkylating agent that is preferentially activated under severe hypoxic tumor conditions, a feature of many solid tumors. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.

On May 15, 2017 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer and other hypoxia-related diseases, reported financial results for the three months ended March 31, 2017 and provided an overview of recent corporate highlights (Press release, RestorGenex, MAY 15, 2017, View Source [SID1234519163]).

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David Kalergis, Chairman and Chief Executive Officer, stated, "With the completion of our recent private placement, we believe we are now well positioned to advance our clinical development strategy for our lead product candidate, trans sodium crocetinate (TSC). We are in dialogue with the U.S. FDA regarding the design of a Phase 3 trial of TSC in newly diagnosed inoperable GBM patients, and plan to complete a protocol review in the third quarter of 2017. Assuming FDA sign-off on final protocol design, the study is planned to initiate by the end of 2017."

Corporate Highlights

In March 2017, U.S. Patent 9,604,899 entitled "Bipolar Trans Carotenoid Salts and Their Uses" was granted by the United States Patent and Trademark Office. This patent expands the coverage of the therapeutic use of TSC and other related compounds to five hypoxia-related conditions including congestive heart failure, chronic renal failure, acute lung injury (ALI), chronic obstructive pulmonary disease (COPD) and respiratory distress syndrome (RDS).

In March 2017, the Company raised aggregate gross proceeds of $25.0 million in an oversubscribed private placement of its Series A convertible preferred stock. At March 31, 2017, the Company had cash and cash equivalents of $12.2 million and a $8.3 million subscription receivable that was received on April 3, 2017.

Three Months Ended March 31, 2017 Financial Results

Research and development expenses were $1.0 million for the three months ended March 31, 2017, compared to $2.4 million for the three months ended March 31, 2016. This decrease in research and development was attributable to a decrease in expenses related to the Company’s pancreatic cancer program and animal toxicology studies.

General and administrative expenses were $1.6 million for the three months ended March 31, 2017, compared to $3.9 million for the three months ended March 31, 2016. The decrease in general and administrative expenses was primarily attributable to a decrease in costs attributable to the reverse merger transaction in January 2016.

We recognized $26.0 million in warrant related expenses (of which $25.6 million was non-cash related and fees netted against gross proceeds) associated with the private placement for the three months ended March 31, 2017, which consisted of the change in fair value of the common stock warrants from issuance,


the excess fair value of the common stock warrants over the gross cash proceeds from the Series A preferred stock offering, and placement agent commissions and other offering costs.

Net loss was $28.6 million for the three months ended March 31, 2017, compared to a net loss of $6.2 million for the three months ended March 31, 2016. For the quarter ended March 31, 2017, the net loss included $26.0 million in warrant related expenses (of which $25.6 million was non-cash related and fees netted against gross proceeds) associated with the private placement. For the three months ended March 31, 2017, net loss attributable to common shares was $28.7 million, which was inclusive of the dividend payable on the Series A convertible preferred stock.

Net cash used in operating activities for the three months ended March 31, 2017 was $3.4 million compared to $4.6 million during the three months ended March 31, 2016.

On May 15, 2017 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported financial results for the first quarter ended March 31, 2017 (Press release, OncoGenex Pharmaceuticals, MAY 15, 2017, View Source [SID1234519151]).

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Recent Events

In January 2017, Achieve Life Science, Inc. (Achieve) and OncoGenex announced they entered into a definitive merger agreement.
In February 2017, OncoGenex announced that apatorsen results from two randomized Phase 2 clinical trials were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2017 Genitourinary Cancers Symposium, held February 16th- 18th in Orlando. Clinical data from trials in bladder and prostate cancers demonstrated apatorsen was well-tolerated and improved patient outcomes when administered in combination with standard-of-care treatments.
In March 2017, Achieve announced a strategic collaboration with the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH) to conduct non-clinical studies in support of an overall clinical development plan for cytisine as a smoking cessation treatment. As part of the collaboration, Achieve is providing cytisine to the NIH to conduct a series of non-clinical studies required by the U.S. Food and Drug Administration (FDA) to support the submission of an Investigational New Drug (IND) application. The collaboration commenced in March 2015 and results of the studies are expected in the second-quarter of 2017.
In March 2017, the Society for Research in Nicotine and Tobacco (SRNT) held a symposium on cytisine research at its annual conference held in Florence, Italy. The symposium was chaired by Professor Nancy Rigotti, MD, Massachusetts General Hospital/Harvard Medical School, with presentations from Associate Professor Natalie Walker, PhD, National Institute for Health Innovation, University of Auckland, on "Cytisine versus Varenicline for Smoking Cessation: Two Clinical Trials from the Australasian Cytisine Trialist Group," and "The Challenge to Getting Cytisine Licensed For Use Worldwide: Policy Considerations." Dr. Walker was the principal investigator of the 1,310 patient phase 3 CASCAID trial published in the New England Journal of Medicine in December, 2014 titled "Cytisine versus Nicotine for Smoking Cessation".
Financial Results

As of March 31, 2017, the company’s cash, cash equivalents, and short-term investments were $16.5 million compared with $25.5 million as of December 31, 2016. Based on current expectations, OncoGenex believes that its cash, cash equivalents, and short-term investments will be sufficient to fund its currently planned operations for at least the next 12 months.

Revenue for the three months ended March 31, 2017 decreased to zero from $2.9 million for three months ended March 31, 2016. Total operating expenses for the three months ended March 31, 2017 were $3.3 million compared to $7.4 million for the same period in 2016. Net loss for the three months ended March 31, 2017 was $3.3 million compared to $3.7 million for the same period in 2016.

As of May 15, 2017 OncoGenex had 30,087,485 shares outstanding.