On August 14, 2018 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) based on its Dolaflexin and other proprietary platforms, reported financial results and a business update for the second quarter ended June 30, 2018 (Press release, Mersana Therapeutics, AUG 14, 2018, View Source [SID1234529009]).

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"Our top priority is to resolve the partial clinical hold placed on our novel drug candidate XMT-1522 for HER2 expressing cancers, and to continue advancing XMT-1536 for solid tumors expressing NaPi2b," said Anna Protopapas, President and CEO of Mersana Therapeutics. "We have submitted our response to the FDA this week and are optimistic that, based on communications with the FDA, we are aligned on a path to lifting the hold."

Clinical Program Status of XMT-1522

As reported on July 19, 2018, the U.S. Food and Drug Administration (FDA) placed the Phase 1 study of XMT-1522 on partial clinical hold following a report to the FDA of a Grade 5 Serious Adverse Event (patient death) in dose level 7 of the XMT-1522 Phase 1 trial. The company continues to dose patients who had started treatment prior to the hold and continue to participate in the trial consistent with the protocol.

Clinical Update on XMT-1536

XMT-1536 is a first-in-class Dolaflexin ADC targeting NaPi2b, which is broadly expressed in epithelial ovarian cancer and non-squamous non-small cell lung cancer, as well as several other rare tumor types. The company continues to dose patients in its Phase 1 dose escalation study. Upon completing the dose escalation phase and selecting a recommended phase 2 dose (RP2D), the company will move into expansion studies in defined patient populations.

Other Recent Highlights and Updates

Further data on our Clinical Programs

·Presented interim dose escalation data on XMT-1522 in select cancers at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. These data showed that as of April 21, 2018, 22 patients had completed the dose limiting toxicity (DLT) evaluation period across 6 dose levels. As of that date, the treatment was well-tolerated, with most adverse events (AEs) for those patients being low grade and manageable; the most common treatment-related AEs were fatigue, nausea, vomiting,

anemia, and transient elevations of AST and ALT. As of the date of the ASCO (Free ASCO Whitepaper) disclosure, six patients had been dosed at dose level 7 (28.3 mg/m2), but only three had completed the first evaluation period. Of the thirteen patients enrolled at doses of 16 mg/m2 or greater at that time, including the three from dose level 7, eleven had stable disease (SD) or better, including one confirmed partial response (PR).

Discovery & Platform Progress

·The company has progressed its research on new payloads, platforms and new molecules and plans to present preclinical data at a major scientific meeting in the fourth quarter of 2018.

Upcoming 2018 Events

·The company will give a corporate presentation on August 15, 2018, at the 2018 Wedbush PacGrow Healthcare Conference in New York City.

·The company will give a corporate presentation at the H.C. Wainwright Healthcare Conference in New York City from September 4 to 6, 2018

·The company will give a corporate presentation on September 6, 2018, at the Baird Healthcare Conference in New York City

·The company will be presenting preclinical data on XMT-1536 at the IASLC World Conference on Lung Cancer in Toronto on September 25, 2018. Data will be presented demonstrating preferential expression of NaPi2b in lung adenocarcinoma, as determined using a new immunohistochemical reagent developed by the company, that can be used to detect NaPi2b expression in tissue samples.

Financial Results

·Cash, cash equivalents and marketable securities as of June 30, 2018, were $96.5 million, compared to $125.2 million as of December 31, 2017. The company expects that its cash, cash equivalents and marketable securities will enable it to fund its operating plan for at least the next twelve months.

·Collaboration revenue for the second quarter 2018 was approximately $4.2 million, compared to $3.7 million for the same period in 2017, primarily due to a $1.5 million milestone achieved during the three months ended June 30, 2018.

·Research and development expenses for the second quarter 2018 were approximately $12.6 million, compared to $10.6 million for the same period in 2017, driven primarily by an increase in employee-related costs due to increased headcount and clinical and in regulatory expenses due to the progress of XMT-1522 and XMT-1536.

· General and administrative expenses for the second quarter 2018 were approximately $4.2 million, compared to $2.2 million for the same period in 2017, driven primarily by increased employee-related expenses due to increase in headcount and increased consulting and professional fees.

· Net loss for the second quarter 2018 was $12.4 million, or $0.54 per share, compared to a net loss of $8.9 million, or $6.33 per share, for the same period in 2017. Weighted average common shares outstanding for the quarter ended June 30, 2018 were 22,966,314 and 1,412,308 for the quarter ended June 30, 2017.

Conference Call

Mersana Therapeutics will host a conference call and webcast at 8:00 am ET on August 15 to report financial results for the second quarter 2018 and provide certain business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 2895337. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

About Dolaflexin

The Dolaflexin platform is designed to increase the efficacy, safety, and tolerability of ADCs by overcoming key limitations of existing technologies based on direct conjugation of a payload molecule to an antibody. Dolaflexin consists of Fleximer, a biodegradable, highly biocompatible, water soluble polymer, to which are attached multiple molecules of Mersana’s proprietary auristatin drug payload using a linker specifically optimized for use with Mersana’s polymer. The high water-solubility of the Fleximer polymer compensates for the low solubility of the payload, surrounding the payload and protecting it from aggregation and maintaining stability in circulation. Multiple molecules of this Dolaflexin polymer-drug conjugate can then be attached to an antibody of choice, which significantly increases the payload capacity of the resulting ADC. This approach differs from most other ADC technologies that conjugate the payload directly to the antibody. Using its Dolaflexin platform, Mersana has been able to generate ADCs with a very high Drug-to-Antibody Ratio (DAR), between 12 to 15, while maintaining desirable pharmacokinetics and drug-like properties in animal models. This represents a three to four-fold increase in DAR relative to traditional ADC approaches. The Dolaflexin platform also incorporates DolaLock technology, an engineered controlled bystander effect. AF-HPA, the initial auristatin drug release product, is freely cell permeable and has bystander-killing capabilities. Intra-tumor metabolism then facilitates the conversion of AF-HPA to AF, which is non-cell permeable, highly potent, and "locked" into the tumor. This enhancement improves both the efficacy and tolerability of Mersana’s ADC candidates.

On August 14, 2018 Agilent Technologies, Inc. (NYSE: A) reported revenue of $1.20 billion for the third quarter ended July 31, 2018, up 8 percent year over year (up 6 percent on a core basis(1)) (Press release, Agilent, AUG 14, 2018, http://www.agilent.com/about/newsroom/presrel/2018/14aug-gp18051.html [SID1234529003]).

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Third-quarter GAAP net income was $236 million, or $0.73 per share. Last year’s third-quarter GAAP net income was $175 million, or $0.54 per share.

During the third quarter, Agilent had intangible amortization of $26 million, acquisition and integration costs of $7 million, transformational initiatives of $4 million, business exit and divestitures of $1 million, $20 million of step-up gain on our initial Lasergen investment, and $5 million in other costs. Excluding these items and a tax benefit of $42 million, Agilent reported third-quarter non-GAAP net income of $217 million, or $0.67 per share(2), up 14 percent year over year.

"The Agilent team continues to capitalize on healthy end markets and delivered another strong quarter," said Mike McMullen, Agilent CEO and president. "Both earnings and revenue growth, led by China and the global pharma and chemical & energy end markets, exceeded expectations. In addition, we achieved our 14th consecutive quarter of improving our year-over-year core operating margins."

"We put our strong balance sheet to work creating value for shareholders and customers," McMullen continued. "We repurchased $243 million in shares, paid $48 million in dividends, and invested $430 million in M&A."

Financial Highlights

Third-quarter revenue of $540 million from Agilent’s Life Sciences and Applied Markets Group (LSAG) grew 6 percent year over year (up 5 percent on a core basis(1)) with strength in the chemical & energy and pharma end markets. LSAG’s operating margin for the quarter was 22.9 percent.

Third-quarter revenue of $426 million from the Agilent CrossLab Group (ACG) grew 10 percent year over year (up 8 percent on a core basis(1)). Both services and consumables saw strong growth across all end markets and geographies. ACG’s operating margin for the quarter was 23.8 percent.

Third-quarter revenue of $237 million from Agilent’s Diagnostics and Genomics Group (DGG) grew 9 percent year over year (up 5 percent on a core basis(1)). Strength in genomics and China led the results. DGG’s operating margin for the quarter was 18.5 percent.

Agilent expects fourth-quarter 2018 revenue in the range of $1.24 billion to $1.26 billion. Fourth-quarter 2018 non-GAAP earnings are expected to be in the range of $0.72 to $0.74 per share(3).

For fiscal year 2018, Agilent expects revenue of $4.86 billion to $4.88 billion and non-GAAP earnings of $2.69 to $2.71 per share(3). The guidance is based on July 31, 2018 currency exchange rates.

Conference Call

Agilent’s management will present more details about its third-quarter fiscal 2018 financial results on a conference call with investors today at 1:30 p.m. (Pacific Time). This event will be webcast live in listen-only mode. Listeners may log on at www.investor.agilent.com and select "Q3 2018 Agilent Technologies Inc. Earnings Conference Call" in the "News & Events — Calendar of Events" section. The webcast will remain available on the company’s website for 90 days.

Additional information regarding financial results can be found at www.investor.agilent.com by selecting "Financial Results" in the "Financial Information" section.

A telephone replay of the conference call will be available at approximately August 14, 2018 at 4:30 PM (Pacific Time) after the call and through August 22 by dialing +1 855-859-2056 (or +1 404-537-3406 from outside the United States) and entering pass code 3179138.

The adjustment for taxes excludes tax benefits that management believes are not directly related to on-going operations and which are either isolated or cannot be expected to occur again with any regularity or predictability. For the three and nine months ended July 31, 2018, management uses a non-GAAP effective tax rate of 18.0%. In the same periods last year, management used a non-GAAP effective tax rate of 16.2% and 18.0%, respectively.
We provide non-GAAP net income and non-GAAP net income per share amounts in order to provide meaningful supplemental information regarding our operational performance and our prospects for the future. These supplemental measures exclude, among other things, charges related to amortization of intangibles, business exit and divestiture costs, transformational initiatives, acquisition and integration costs, pension settlement gain, gain on step acquisition of Lasergen, NASD site costs, special compliance costs, and adjustment for Tax Reform.
Business exit and divestiture costs include costs associated with business divestitures.
Transformational initiatives include expenses associated with targeted cost reduction activities such as manufacturing transfers including costs to move manufacturing due to new tariffs and tariff remediation actions, small site consolidations, legal entity and other business reorganizations, insourcing or outsourcing of activities. Such costs may include move and relocation costs, one-time termination benefits and other one-time reorganization costs. Included in this category are also expenses associated with company programs to transform our product lifecycle management (PLM) system, human resources and financial systems.
Acquisition and Integration costs include all incremental expenses incurred to effect a business combination. Such acquisition costs may include advisory, legal, accounting, valuation, and other professional or consulting fees. Such integration costs may include expenses directly related to integration of business and facility operations, the transfer of assets and intellectual property, information technology systems and infrastructure and other employee-related costs.
Pension settlement gain resulted from transfer of the substitutional portion of our Japanese pension plan to the government.
Gain on step acquisition of Lasergen resulted from the measurement at fair value of our equity interest held at the date of business combination.
NASD site costs include all the costs related to the expansion of our manufacturing of nucleic acid active pharmaceutical ingredients incurred prior to the commencement of commercial manufacturing.
Special compliance costs include costs associated with transforming our processes to implement new regulations such as the EU’s General Data Protection Regulation (GDPR), revenue recognition and certain tax reporting requirements.
Other includes certain legal costs and settlements in addition to other miscellaneous adjustments.
Adjustment for Tax Reform primarily consists of an estimated provision of $480 million for U.S. transition tax and correlative items on deemed repatriated earnings of non-U.S. subsidiaries and an estimated provision of $53 million associated with the decrease in the U.S. corporate tax rate from 35% to 21% and its impact on our U.S. deferred tax assets and liabilities. The taxes payable associated with the transition tax, net of tax attributes, on deemed repatriation of foreign earnings is approximately $440 million, payable over 8 years. The final impact of Tax Reform may differ materially from these estimates, due to, among other things, changes in interpretations, analysis and assumptions made, additional guidance that may be issued, and actions that we may undertake.
Our management uses non-GAAP measures to evaluate the performance of our core businesses, to estimate future core performance and to compensate employees. Since management finds this measure to be useful, we believe that our investors benefit from seeing our results "through the eyes" of management in addition to seeing our GAAP results. This information facilitates our management’s internal comparisons to our historical operating results as well as to the operating results of our competitors.
Our management recognizes that items such as amortization of intangibles can have a material impact on our cash flows and/or our net income. Our GAAP financial statements including our statement of cash flows portray those effects. Although we believe it is useful for investors to see core performance free of special items, investors should understand that the excluded items are actual expenses that may impact the cash available to us for other uses. To gain a complete picture of all effects on the company’s profit and loss from any and all events, management does (and investors should) rely upon the GAAP income statement. The non-GAAP numbers focus instead upon the core business of the company, which is only a subset, albeit a critical one, of the company’s performance.
Readers are reminded that non-GAAP numbers are merely a supplement to, and not a replacement for, GAAP financial measures. They should be read in conjunction with the GAAP financial measures. It should be noted as well that our non-GAAP information may be different from the non-GAAP information provided by other companies.
The preliminary non-GAAP net income and diluted EPS reconciliation is estimated based on our current information.

We compare the year-over-year change in revenue excluding the effect of recent acquisitions and divestitures and foreign currency rate fluctuations to assess the performance of our underlying business.
(a) The constant currency year-over-year growth percentage is calculated by recalculating all periods in the comparison period at the foreign currency exchange rates used for accounting during the last month of the current quarter, and then using those revised values to calculate the year-over-year percentage change.
(b) The dollar impact from the current quarter currency impact is equal to the total year-over-year dollar change less the constant currency year-over-year change.
The preliminary reconciliation of GAAP revenue adjusted for recent acquisitions and divestitures and impact of currency is estimated based on our current information.

On August 14, 2018 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or "the Company"), reported that it will conduct a conference call on Wednesday, August 15, 2018 at 9:00 AM ET to provide an update on the Pivotal Phase 3 SIERRA Trial (Study of Iomab-B in Elderly Relapsed/Refractory AML) of Iomab-B (Press release, Actinium Pharmaceuticals, AUG 14, 2018, View Source [SID1234528958]). Actinium recently announced that the SIERRA trial had reached twenty-five percent patient enrollment and that the independent Data Monitoring Committee (DMC) would conduct a formal analysis, which has now occurred. Post this event, members of Actinium’s management team are hosting this call to provide an update on the SIERRA trial.

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Conference Call Details

Date: Wednesday, August 15, 2018
Time: 9:00 AM ET
Registration Link: View Source
Toll-Free Dial-in: (855) 427-0225
Dial-in: (718) 865-8336
Conference ID: 4831

"Based on the DMC’s unanimous recommendation, we are pleased that the ongoing SIERRA trial will continue as planned," said Dr. Mark Berger, Chief Medical Officer of Actinium. "This is an important milestone for Iomab-B since it is the first formal safety evaluation of the trial. We note that no Iomab-B safety concerns were raised. With new insights from the data available from the trial thus far as well as feedback from the trial sites, we will make certain protocol revisions to further expand salvage regimens in the control arm. We’ll also be making it easier for patients on the Conventional Care arm who have disease progression to access Iomab-B treatment. In addition, we will be simplifying certain data collection requirements. These improvements coupled with our deeper understanding of referral patterns and other outreach efforts, are anticipated to enable the recently strengthened SIERRA clinical team to complete the trial as quickly as possible with the goal of bringing Iomab-B to a patient population with a significant unmet need."

Sandesh Seth, Actinium’s Chairman and CEO added, "Iomab-B is a very compelling drug candidate that has been studied in over 500 patients in multiple hematologic malignancies including AML, myelodysplastic syndrome, lymphoma and multiple myeloma and is intended to facilitate a potentially curative bone marrow transplant. Iomab-B was developed by the Fred Hutchinson Cancer Research Center in collaboration with the National Cancer Institute and has been studied extensively by leading bone marrow transplant physicians. We are incredibly proud of the pedigree of Iomab-B and motivated by its potential to address unmet medical needs as a targeted conditioning agent in multiple hematologic diseases. We believe that Iomab-B via the SIERRA trial can be the linchpin for developing the leading franchise in targeted conditioning with an emphasis on improving bone marrow transplant access and outcomes."

About Iomab-B

Iomab-B, Actinium’s lead targeted conditioning product candidate, is currently being studied in a 150-patient, multicenter pivotal Phase 3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. This pivotal Phase 3 study is called the SIERRA Trial (Study of Iomab-B in Elderly Relapsed/Refractory AML). Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B targets cells that express CD45, an antigen widely expressed in the hematopoietic system on all leukemic and lymphomic (white blood cells), bone marrow cells and cancer stem cells with the monoclonal antibody, BC8 or apamistamab, labeled with the radioisotope, iodine-131. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects that conventional treatments such as chemotherapy and radiation has on most healthy tissues while effectively killing the patient’s cancer and marrow cells potentially enabling more bone marrow transplants with better outcomes through targeted conditioning. In a Phase 2 clinical study in 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDS) age 50 and older, who typically would not be transplant candidates, were able to receive a transplant after being conditioned with Iomab-B and the study resulted in significantly improved transplant success and survival. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in almost 500 patients in a number of Phase 1 and Phase 2 clinical trials across a variety of blood cancer indications with promising results. The studies included patients with acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.

On August 14, 2018 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late stage clinical trials for the treatment of patients with urological diseases, reported financial results for the second quarter 2018 and recent corporate highlights (Press release, Sophiris Bio, AUG 14, 2018, View Source [SID1234528933]).

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"In the second quarter, we announced top-line interim safety and biopsy data following a single administration of topsalysin from our ongoing Phase 2b clinical trial in low to intermediate risk localized prostate cancer," said Randall E. Woods, president and CEO of Sophiris. "The 29% (10/35 patients) clinical response rate we observed was extremely encouraging and provides the foundation for the next stage of development. We and our scientific advisors believe the initial data support advancing topsalysin for the treatment of localized prostate cancer into potential registration trials, and we will continue to evaluate the merits of administering a second dose. Looking ahead for the rest of the year, we are continuing our manufacturing activities to ensure drug supply for potential Phase 3 trials, we plan to advance dialogue with the regulatory agencies around a potential Phase 3 trial design in patients with localized prostate cancer and, once available, we will evaluate safety and biopsy data from the patients who received a second administration of topsalysin."

Second Quarter Corporate Highlights:

Positive top-line interim results from Phase 2b trial in localized prostate cancer. On June 25, the Company announced top-line safety and six month follow-up biopsy data from 35 patients with pre-identified, clinically-significant localized prostate cancer that were treated with a single administration of topsalysin.

Safety analysis, following a single administration of topsalysin in this study indicates that, to date, topsalysin has been well-tolerated; no hypersensitivity reactions or other serious systemic reactions to study medication have been observed after a single administration.

Based on the six-month follow-up biopsy results, 29% of patients (10/35) demonstrated a clinical response. Of the 10 clinical responders in the Phase 2b trial, six patients experienced a complete ablation with no histological evidence of the targeted tumor remaining. In addition, 37% of patients (13/35) experienced a partial response, but the targeted lesion was still deemed clinically-significant based on the targeted biopsy.

Two additional patients have received six-month follow-up biopsies following their first administration of topsalysin. The Company expects to report updated data following receipt of the results of these biopsies.

Independent Data Monitoring Committee recommendation to continue clinical trial as planned. In May 2018, an Independent Data Monitoring Committee (IDMC) met to review the safety data from all 38 patients administered a single dose of topsalysin as well the safety data available from the first seven patients who received a second administration of topsalysin. At that time, the IDMC unanimously recommended the clinical trial continue without changes to the protocol.

Second administration completed in Phase 2b trial. The Phase 2b study was designed to include an option to re-treat patients who did not have any clinically-significant adverse events and who responded to the first administration of topsalysin but still had a targeted lesion remaining.

Eleven patients received a second administration of topsalysin in the Phase 2b clinical trial. The eleventh patient died on the same day he received a second administration of topsalysin. The death did not occur during the procedure. As a precaution, Sophiris elected to halt further re-administration and no additional patients have received a second administration of topsalysin in the Phase 2b clinical trial. The event is under active review.

The Company expects to have six month follow-up biopsy results and additional safety data from all patients who received a second administration of topsalysin in its ongoing Phase 2b trial in localized prostate cancer patients late in the fourth quarter of 2018.

Financial Results:

At June 30, 2018, the Company had cash, cash equivalents and securities available-for-sale of $18.5 million and working capital of $14.1 million. The Company expects that its cash and cash equivalents will be sufficient to fund its operations through June 2019, assuming no new clinical trials are initiated. The Company will require significant additional funding to advance topsalysin in clinical development. As of June 30, 2018, the outstanding principal balance of our term loan was $7 million on which the Company is currently making monthly interest only payments.

For the three months ended June 30, 2018

The Company reported a net loss of $6.1 million or ($0.20) per share for the three months ended June 30, 2018, compared to net income of $0.6 million or $0.02 per share for the three months ended June 30, 2017. The net income for the three months ended June 30, 2017 was driven by a non-cash gain related to the revaluation of the Company’s warrant liability. See an additional discussion below related to this item.

Research and development expenses

Research and development expenses were $3.6 million for the three months ended June 30, 2018, compared to $1.4 million for the three months ended June 30, 2017. The increase in research and development costs is primarily attributable to increases in the costs associated with manufacturing activities for topsalysin, and to a lesser extent, an increase in clinical costs associated with our Phase 2b clinical trial of topsalysin for the treatment of localized prostate cancer.

General and administrative expenses

General and administrative expenses were $1.1 million for the three months ended June 30, 2018, compared to $1.4 million for the three months ended June 30, 2017. The decrease in general and administrative expense is primarily due to decreases in non-cash stock-based compensation expense and consulting services.

Gain (loss) on revaluation of the warrant liability

Loss on revaluation of the warrant liability was $1.4 million for the three months ended June 30, 2018, compared to a gain of $3.3 million for the three months ended June 30, 2017. As these warrants may require the Company to pay the warrant holder cash under certain provisions of the warrant, the Company accounts for these warrants as a liability, and the Company is required to calculate the fair value of these warrants each reporting date. The non-cash loss reported for the three months ended June 30, 2018, is associated with a increase in the fair value of the Company’s warrant liability from March 31, 2018, to June 30, 2018, which is calculated using a Black-Scholes pricing model. Certain inputs utilized in the Company’s Black-Scholes fair value calculation may fluctuate in future periods based upon factors which are outside of the Company’s control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change to the fair value of the Company’s warrant liability, which could also result in a material non-cash gain or loss being reported in the Company’s consolidated statement of operations and comprehensive loss.

For the six months ended June 30, 2018

The Company reported a net loss of $9.4 million or ($0.31) per share for the six months ended June 30, 2018 compared to a net loss of $2.0 million or ($0.07) per share for the six months ended June 30, 2017.

Research and development expenses

Research and development expenses were $6.9 million for the six months ended June 30, 2018 compared to $2.6 million for the six months ended June 30, 2017. The increase in research and development costs is primarily attributable to increases in the costs associated with manufacturing activities for topsalysin, and to a lesser extent, an increase in clinical costs associated with our Phase 2b clinical trial of topsalysin for the treatment of localized prostate cancer.

General and administrative expenses

General and administrative expenses were $2.3 million for the six months ended June 30, 2018 compared to $2.7 million for the six months ended June 30, 2017. The decrease in general and administrative expense is primarily due to decreases in non-cash stock-based compensation expense and consulting services.

Gain (loss) on revaluation of the warrant liability

Loss on revaluation of the warrant liability was $10 thousand for the six months ended June 30, 2018 as compared to a gain of $3.2 million for the six months ended June 30, 2017. The non-cash loss reported for the six months ended June 30, 2018, is associated with an increase in the fair value of our warrant liability from December 31, 2017 to June 30, 2018.

On August 14, 2018 ProMIS Neurosciences, Inc. (TSX: PMN; OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the three and six months ended June 30, 2018 (Press release, ProMIS Neurosciences, AUG 14, 2018, View Source [SID1234528931]).

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"Over the first half of 2018, we focused on three key priorities to advance our business", stated ProMIS Executive Chairman, Eugene Williams. "First, to continue to push toward our goal of initiating the first clinical trial of PMN310 in the second half of 2019; second, to differentiate the oligomer selectivity of PMN310 as best in class profile for the treatment of Alzheimer’s disease (AD) versus other amyloid-beta directed therapies in development; and third, to expand our portfolio by developing therapeutic antibodies targeting toxic oligomers of alpha-synuclein for Parkinson’s disease (PD) and toxic aggregates of Tar-DNA binding protein (TDP43) for ALS. We are pleased to be on target to meet our objectives for the year and look forward to communicating our accomplishments."

Recent Corporate Highlights

On May 1, we announced completion of a private placement of 19,306,668 common share units at a price of $0.375 per unit, for gross proceeds of approximately $7,240,000. Each unit consisted of one common share and one-half of a common share purchase warrant. Each whole warrant is exercisable into one common share at a price of $0.48 per share for a 60-month exercise period, subject to earlier expiry on 30 days’ notice if, at any time after four months from closing, the 20-day volume-weighted average trading price of the Company’s common shares is greater than CDN$1.00. Net proceeds from the private placement will be used for working capital and general corporate purposes.
During the second quarter of 2018, we received proceeds of $1,550,204 related to the exercise of common stock warrants and stock options. The warrants were exercisable at $0.17, $0.20 and $0.30.
On April 10, we announced publication of a peer reviewed scientific paper describing a novel target on toxic oligomers of amyloid-beta in AD.
On June 12, we announced the initiation of producer cell line development for PMN310, our lead therapeutic antibody candidate for treatment of AD. Selexis, SA will carry out this critical first step in the manufacturing of antibody therapeutics using their proprietary Selexis SUREtechnology Platform.
On June 26, we announced that our unique discovery platform generated potential new antibody therapeutic candidates targeting toxic oligomers implicated in the development and progression of PD and ALS.
On June 28, we announced results of the Annual Meeting of Shareholders, whereby all of the resolutions announced in the Management Proxy Circular and placed before the Meeting were overwhelmingly approved by the shareholders.
Financial Results

Results of Operations – Three months ended June 30, 2018 and 2017

The net loss for the three months ended June 30, 2018 was $2,214,861, compared to a net loss of $1,903,396 for the three months ended June 30, 2017. The increased loss in the current period reflects the costs associated with operating the Company’s AD therapeutics program, increased contract research and consultant salaries and associated costs, supporting its patent portfolio and general corporate expenditures.

Research and development expenses for the three months ended June 30, 2018 were $1,531,075, as compared to $1,132,258 in the three months ended June 30, 2017. Costs were higher in the current period due to higher research program costs for the AD therapeutics program, recruiting expenses and higher costs to support its patent portfolio, offset by lower stock-based compensation.

General and administrative expenses for the three months ended June 30, 2018 were $683,786, as compared to $768,696 in the three months ended June 30, 2017. The decreased in expenditures in the current period reflect reduced investor relations expenses and foreign exchange expense, offset by higher consultant salaries and associated costs, other professional fees, and stock-based compensation.

Results of Operations – Six months ended June 30, 2018 and 2017

The net loss for the six months ended June 30, 2018 was $3,771,733, compared to a net loss of $3,275,599 for the six months ended June 30, 2017. The increased loss in the current period reflects the costs associated with operating the Company’s AD therapeutics program, increased contracted research and consultant salaries and associated costs, supporting its patent portfolio and general corporate expenditures.

Revenues for the six months ended June 30, 2018 and 2017 were nominal and relate to legacy technologies.

Research and development expenses for the six months ended June 30, 2018 were $2,229,082, as compared to $1,851,360 in the six months ended June 30, 2017. Costs are higher in the current period due to higher research program costs for the AD therapeutics program, recruiting expenses and higher costs to support its patent portfolio, offset by lower stock-based compensation.

General and administrative expenses for the six months ended June 30, 2018 were $1,542,656, as compared to $1,420,056 in the six months ended June 30, 2017. The increased expenditures in the current period reflect increased consultant salaries and associated costs and higher stock-based compensation, offset by foreign exchange gains.

Outlook

The Company plans to further advance its AD portfolio, with a focus on development of PMN310 for clinical trial initiation in the second half of 2019. Based on the highly selective binding of PMN310 to the toxic Aβ oligomers and lack of off-target binding to non-toxic forms of Aβ (monomer, plaque), the ProMIS AD program will continue to develop data further supporting potential best in class safety and efficacy versus other Aβ-directed therapies currently in development.

Finally, using its unique technology platform, we will advance work to identify and validate selective antibody therapies for the toxic oligomers of alpha synuclein in PD and TDP43 in ALS, with a view to partnering these assets.