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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, reported financial results for the second quarter and six months ended June 30, 2018 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, CASI Pharmaceuticals, AUG 14, 2018, View Source [SID1234528921]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, commented, "Our financial results for the second quarter of 2018 are in line with our expectations. We have made tremendous progress since the start of 2018 and remain committed to working with the relevant regulatory authorities and our strategic partners in the U.S. and in China to provide high quality, life-saving medications to patients. We will continue to advance our current product portfolio while evaluating additional opportunities to add further medicines to our pipeline."

Second Quarter and Recent Business Highlights

China FDA (CFDA) import drug registration priority review of EVOMELA in progress – On April 26, 2018, the Center for Drug Evaluation (CDE) of the China FDA held a Clinical Advisory Committee (the "Advisory Committee") meeting to review the EVOMELA application. CASI has recently received a series of standard questions from the CFDA related to EVOMELA drug product production which usually reflect the final stage of CFDA assessment before approval based on the Import Drug Approval registration pathway. CASI is working with Spectrum Pharmaceuticals and its vendors from whom EVOMELA is in-licensed to address the questions and submit the requested documents.

Preparation continues for EVOMELA’s commercial launch in China – CASI is building an in-house marketing and sales team with key members in place. The team is led by Thomas Zhang who has a 20-year track record of commercialization of multiple anti-cancer drugs in China for companies such as Roche and Johnson & Johnson.

CFDA review in progress for MARQIBO and ZEVALIN – CASI continues to work with the CFDA on advancing MARQIBO’s import drug clinical trial application and anticipates that the regulatory agency will complete its review within the next four to six months. The import drug clinical trial application for ZEVALIN is also in process with CFDA. The ZEVALIN antibody kit and the radioactive Yttrium-90 component of the application require separate submissions of which both are currently under technical review by the CDE of CFDA and the quality confirmatory testing by National Institute for Food and Drug Control (NIFDC) of CFDA as part of the regulatory review process.

Company enters into strategic manufacturing agreement – In June 2018, CASI entered into a strategic and long-term contracting manufacturing agreement for the manufacturing of entecavir and cilostazol. The partnership will support CASI’s plan to market and sell both products in China, U.S. and worldwide markets. Entecavir and cilostazol are part of the 29 abbreviated new drug applications (ANDAs) that were acquired from Sandoz in January 2018.

CASI added to Russell 2000, 3000 and Microcap Indexes – In July 2018, CASI announced that the company has been added to the Russell 2000, 3000 and Microcap Indexes.

Second Quarter and First Half 2018 Financial Results

Cash Position: As of June 30, 2018, CASI had cash and cash equivalents of $66.2 million compared to $49.9 million as of March 31, 2018. This increase primarily reflects the remaining gross proceeds of $20.7 million received in April 2018 related to CASI’s $50 million private placement announced in March 2018, partially offset by costs related to operating expenses during the quarter.

R&D Expenses: Research and development (R&D) expenses for the three and six months ended June 30, 2018, were $1.7 million and $3.4 million, respectively, compared to $1.7 million and $2.8 million for the same periods in 2017. The increase in R&D expenses primarily reflects personnel costs associated with the technology transfer activities and regulatory support associated with the recently acquired ANDA portfolio, offset by a decrease in costs related to the timing of the CFDA regulatory process of CASI’s in-licensed U.S. FDA approved assets from Spectrum Pharmaceuticals.

G&A Expenses: General and administrative (G&A) expenses for the three and six months ended June 30, 2018, were $4.0 million and $5.3 million, respectively, compared to $0.7 million and $1.3 million for the same periods in 2017. The increase in G&A over the prior year is primarily attributed to non-cash stock-based compensation expense for the stock options issued to the Company’s Executive Chairman and an increase in salary, benefits and recruitment expense in China, largely related to sales and marketing efforts to prepare for the anticipated launch of the Company’s first commercial product in China, as well as other G&A functions. There were also increased costs associated with business development related to exploratory acquisition activities, investor and public relations activities, and an increase in legal and other professional services fees during the 2018 period. G&A expenses include non-cash stock-based compensation of $1.5 million and $1.6 million for the three and six months ended June 30, 2018, respectively, compared to $0.1 million and $0.2 million in the respective periods in 2017.

Net Loss: The Company reported a net loss attributable to common shareholders for the three and six months ended June 30, 2018 of ($5.9) million, or ($0.07) per share, and ($9.5) million, or ($0.12) per share, respectively, compared to ($2.4) million, or ($0.04) per share, and ($4.1) million, or ($0.07) per share for the same periods in 2017. The larger net loss is primarily due to the non-cash stock-based compensation expense for stock options issued to the Company’s Executive Chairman, costs associated with the technology transfer activities and regulatory support for our ANDA portfolio, the write-off of approximately $0.7 million in January 2018 due to acquired in-process R&D primarily related to ANDAs not approved by the FDA, and increased costs associated with G&A functions, including employment costs for sales and marketing efforts, increased business development and investor relations activities, as well as other professional service fees.

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, can be found at www.casipharmaceuticals.com.

On August 14, 2018 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported financial and operating results for the second quarter ended June 30, 2018 as well as an update on its strategic direction and key organizational initiatives (Press release, Cancer Genetics, AUG 14, 2018, View Source [SID1234528920]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

John A. Roberts, Chief Executive Officer of Cancer Genetics said, "During the second quarter of 2018, we made significant advances in reorienting the company and are continuing to take the necessary steps to increase the efficiency of our overall business portfolio and accelerate our path to profitability.

"We are making good progress in consolidating the operations of our West Coast molecular profiling laboratory and moving these capabilities to our facilities in New Jersey and North Carolina. We believe that the consolidation of the Los Angeles facility will reduce our operating expenses, making a positive contribution towards our cost structure consistent with our growth and transformation strategy for 2018 and beyond."

Mr. Roberts added, "To supplement our efforts aimed at growing our biopharma business, we strengthened our management team with the appointment of Michael McCartney as the company’s Chief Commercial Officer. Michael will be responsible for overseeing our commercial strategy and leading the Company’s business development initiatives. To that end, I am particularly pleased with the recent developments in our biopharma channel strategy with an increased velocity of project work with our channel partner firms. We have a solid, collaborative foundation stemming from previous partnership agreements signed in 2016, and have recently begun expanding the scope of our work with these partners."

Mr. Roberts concluded, "On the financial front, we recently completed a convertible note financing and raised $2.5 million to support the execution of our 2018 transformation and strategic plan to reorganize our business and position the company for future growth. Further, our engagement with Raymond James as a financial advisor in evaluating strategic options continues to progress, as we have been engaged in discussions regarding several potential transactions and hope to make an announcement concerning these developments in the near future. Overall, we are committed to executing on our growth strategy and remain focused on making CGI a premier company in the precision oncology arena."

SECOND QUARTER 2018 AND RECENT OPERATIONAL HIGHLIGHTS

Strengthened leadership team with appointment of Michael McCartney as Chief Commercial Officer.
Completed sale of wholly-owned subsidiary BioServe Biotechnologies (India) Private Limited to REPROCELL for $1.9 million in April 2018.
Raised $2.5 million through a convertible note financing in July 2018.
Progressed the consolidation of the West Coast molecular profiling laboratory and relocation of most of these activities to New Jersey and North Carolina laboratories, as part of 2018 transformation strategy. The consolidation of this facility is currently expected to be complete by the end of the third quarter, and reduce operating expenses by over $4 million annually once completed.
SECOND QUARTER 2018 FINANCIAL RESULTS

The Company reported total revenue of $7.0 million for the second quarter of 2018 compared to revenue of $6.6 million in second quarter of 2017, an increase of 7% or $0.4million.

Biopharma services revenue totaled $3.6 million in the second quarter, compared to $3.3 million during the second quarter 2017. Biopharma projects are dependent on the timing, size and duration of our contracts with pharmaceutical and biotech companies and clinical research organizations, and can fluctuate in comparable periods. The Company increased the number of clinical studies and trials it is supporting to 342, up from 170 in Q2 2017. The Company’s booking-to-billing ratio for Q2 2018 was 2.5.

​Clinical Services revenue decreased by approximately $1 million in the second quarter of 2018 compared to the same period in 2017, from $3.1 million to $2.1 million.

The Company’s Discovery Services contributed $1.3 million in revenue for the second quarter of 2018 driven by our acquisition of vivoPharm in August of 2017. This represents an increase of approximately $1.0 million as compared to $0.3 million in revenue for the second quarter of 2017.

Gross profit margin was 31% or $2.2 million in Q2 2018, compared to 39% or $2.6 million in the second quarter 2017.

Total operating expenses for the second quarter of 2018 were approximately $7.4 million, an increase of 30% compared to $5.7 million during the second quarter of 2017, principally due to restructuring costs of $0.7 million, an increase in our professional fees of $0.5 million related to recent financing and M&A activities, an increase in our bad debt expense of $0.2 million, and an increase in our selling expenses of $0.1 million.

Net loss was $3.6 million or $0.13 per share for the second quarter of 2018, compared to a net loss of $2.8 million or $0.16 per share for the second quarter of 2017.

Cash and cash equivalents as of June 30, 2018 totaled $1.6 million, compared to $4.0 million as of March 31, 2018. In July 2018, the Company closed a convertible note financing generating net proceeds of approximately $2.5 million.

As announced previously, the Company engaged Raymond James & Associates, Inc. as a financial advisor to assist with evaluating options for the Company’s strategic direction. These options may include raising additional capital, the acquisition of another company and / or complementary assets, the sale of the Company, or another type of strategic partnership.

CONFERENCE CALL & WEBCAST
Tuesday, August 14, 2018, 8:30 a.m. Eastern Time
Domestic: 800-289-0438
International: 323-794-2423
Conference ID: 1766530
Webcast: View Source
Replay – Available through August 28, 2018
Domestic: 844-512-2921
International: 412-317-6671
Conference ID: 1766530

On August 14, 2018 Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported its financial results and business highlights for the three and six months ended June 30, 2018 (Press release, Athenex, AUG 14, 2018, View Source;p=RssLanding&cat=news&id=2363558 [SID1234528919]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The second quarter was marked by notable achievements across clinical, operational and financial fronts," stated Dr. Johnson Lau, Chief Executive Officer of Athenex. "We announced positive Phase 3 data with our lead Src Kinase inhibitor KX2-391 in actinic keratosis and, together with our commercial partner Almirall, we are now planning regulatory submissions in the major markets. We continue to seek opportunities to expand our oncology pipeline and announced, in July, the licensing of two very exciting technologies, an immunotherapy platform based on T-cell receptor-engineered T cells or TCR-T, and a metabolic based oncology candidate."

Dr. Lau continued, "Our commercial business continues to perform well and grow, with both Athenex Pharmaceutical Division and Athenex Pharma Solutions launching new products. We also continue to invest in our global supply chain platform, with the goal of having the right infrastructure in place in advance of commercializing our Oncology Innovation Products."

Second Quarter 2018 and Recent Business Highlights:

Second quarter revenue increased to $11.6 million as compared to $4.6 million in the same period last year.
Clinical Platforms:

Announced positive data from two Phase 3 studies of KX2-391 in actinic keratosis (AK). Each study achieved the primary endpoint of 100% clearance of AK lesions in patients following treatment, at high statistical significance (p<0.0001).
Received Orphan Drug Designation from the US FDA for Oraxol in angiosarcoma, a rare form of malignant blood vessel cancer
Presented Phase 1 data evaluating the safety, tolerability, pharmacokinetics and activity of Oraxol in patients with advanced malignancies, and a bioavailability study of oral paclitaxel and HM30181 compared with weekly intravenous (IV) paclitaxel in patients with advanced solid tumors, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.
Commercial Business:

Launched 5 new products and 12 new SKUs during the second quarter.
Athenex Pharmaceutical Division ("APD") currently markets 21 products in the U.S. with 36 SKUs.
Athenex Pharma Solutions ("APS"), our 503(b) facility, currently markets 5 products with 27 SKUs.
Business Development and Strategic Highlights:

Received a strategic investment of $100 million from Perceptive Advisors
Establishing a joint venture with Xiangxue Life Sciences for the research, development, and commercialization of T-cell Receptor-Engineered T Cells (TCR-T), a next generation cancer immunotherapy technology.
In-licensed worldwide rights to pegylated genetically modified human arginase from Avalon Polytom (HK) Limited.
Strengthened Company leadership and Board with the appointments of Timothy Cook as Senior Vice President of Global Commercial Oncology; Christina Wang as Vice President of Clinical Operations and Corporate Development, Asia Pacific; and Benson Tsang to the Board of Directors.
Second Quarter 2018 Financial Results:

Revenue for the second quarter ended June 30, 2018 was $11.6 million as compared to $4.6 million in the same period last year. The increase was primarily attributable to a $5.2 million increase in specialty products sold through the Company’s Commercial Platform, a $1.4 million increase in API and medical device sales, and $0.6 million in sales of its 503B products. This increase was offset by decreases in contract manufacturing revenue of $0.1 million and a decrease in grant revenue of $0.1 million.

Cost of sales for the second quarter ended June 30, 2018 totaled $9.4 million, as compared to $4.1 million for the three months ended June 30, 2017. This was primarily due to the increase of $4.1 million cost of sales from the recently launched specialty products and $1.2 million cost of sales from 503B and API products

R&D expenses for the second quarter ended June 30, 2018 were $26.6 million, an increase of $9.0 million from a year ago. The increase was primarily due to an increase in clinical operations and included a $6.5 million increase in clinical trial costs related to the progression of the Phase 3 trials of KX-01 Ointment and Oraxol.

SG&A expenses for the second quarter ended June 30, 2018 were $12.8 million, a decrease of $0.8 million compared to $13.6 million in the same period last year. The decrease was primarily due to a decrease in employee compensation of $2.8 million from stock-based compensation incurred in the prior year in connection with the Company’s IPO, offset by a $1.9 million increase in other office expenses and professional fees for legal, consulting, and audit services related to operating as a public company.

Net loss for the second quarter ended June 30, 2018 was $36.9 million, or $0.58 per diluted share, compared to a net loss of $38.6 million, or $0.88 per diluted share, in the same period last year.

Cash, cash equivalents and short-term investments were $80.7 million at June 30, 2018, compared to $51 million at December 31, 2017. The company remains focused on using its cash position to fund development of the clinical pipeline, as well as working capital costs associated with the commercial platform and general corporate purposes.

In July 2018, Athenex closed a privately placed debt and equity financing deal with Perceptive Advisors, LLC for gross proceeds of $100.0 million and aggregate net proceeds of $97.1 million, net of fees and offering expenses. The Company entered into a 5-year senior secured loan for $50.0 million of this financing and issued 2,679,528 shares of its common stock at a purchase price of $18.66 per share for the remaining $50.0 million. The Company is required to make monthly interest-only payments with a bullet payment of the principal at maturity. In connection with the loan agreement, the Company also granted Perceptive a warrant for the purchase 425,000 shares of common stock at a purchase price of $18.66 per share.

In July 2018, Athenex executed a subscription agreement to establish, operate, and manage a limited liability company, Axis Therapeutics Limited, based in Hong Kong. This joint venture will be owned 55% by the Company and 45% by Xiangxue Life Sciences. The Company will make a capital contribution of $30.0 million to the joint venture. Subsequently, Axis Therapeutics Limited entered into a license agreement with the minority partner to license its TCR-T immunotherapy technology to develop and commercialize products for oncology indications. The Company will make an upfront payment for this license in the form of a $5.0 million issuance of its common stock.

First Half 2018 Financial Results

Revenue for the six months ended June 30, 2018 was $49.4 million compared to $9.2 million in the same six month period of last year. The increase was primarily attributable to $25.0 million of upfront license fees related to the collaboration agreement with Almirall, S.A. and a $13.8 million increase in specialty products sold through the Company’s Commercial Platform.

Cost of sales for the six months ended June 30, 2018 was $20.8 million, as compared to $7.0 million for the six months ended June 30, 2017. This was primarily due to the increase of $11.3 million cost of sales from the recently launched specialty products and $2.5 million cost of sales from 503B and API products.

R&D expenses for the first six months of 2018 were $47.9 million, an increase of $3.9 million from the $44.0 million from the year ago period. This was primarily due to an increase in clinical operations and included a $13.4 million increase in clinical trial costs related to the progression of the Phase 3 trials of KX-01 Ointment and Oraxol.

SG&A expenses were $25.9 million, an increase of $2.5 million compared to $23.4 million in the same period last year. This increase was primarily due to a $3.3 million increase of other office expenses and professional fees for legal, consulting, and audit services related to operating as a public company.

Net loss for the six months ended June 30, 2018 was $44.2 million, or $0.71 per diluted share, compared to a net loss of $79.6 million, or $1.89 per diluted share, for the six months ended June 30, 2017.

Outlook and Upcoming Milestones:

The Company is reaffirming its full year 2018 revenue guidance in the range of $100 million to $125 million, inclusive of licensing-fee revenue from Almirall.

Clinical Platforms:

A second interim analysis by the Data and Safety Monitoring Board (DSMB) for the ongoing Phase 3 trial of Oraxol in metastatic breast cancer is expected in September
IND filing for Oral Eribulin is planned for Q4-2018
Corporate Updates:

Construction on the Dunkirk facility is expected to be complete by the first quarter of 2019.
Conference Call and Webcast Information:

The Company will host a conference call and audio webcast on Tuesday, August 14, 2018 at 9:00 a.m. Eastern Time. To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13682063.

A replay of the call will be accessible two hours after its completion through August 21 by dialing 844-512-2921 (in the U.S.) or 412-317-6671 (outside the U.S.) and entering passcode 13682063. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at www.athenex.com.