On May 15, 2018 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported financial results for the first quarter ended March 31, 2018 (Press release, AmpliPhi Biosciences, MAY 15, 2018, View Source [SID1234526634]).

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"From the ongoing expanded access program, we are gathering initial evidence of safety and efficacy of AB-SA01 and AB-PA01 in patients with serious and life-threatening infections," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "We continue to target a meeting with the FDA in mid-2018 to define a path forward to regulatory approval, with the potential for us to initiate a Phase 2 or registrational clinical study as early as the fourth quarter of 2018."

Recent Business Highlights

Announced positive topline results for the initial seven patients treated with AB-SA01 or AB-PA01 under the ongoing single-patient expanded access program. Six of the seven patients (86%) achieved treatment success (physician’s assessment), defined as complete resolution or significant improvement of baseline signs and symptoms. All patients were severely ill with life-threatening infections and unresponsive to antibiotics at the time of treatment. Treatment was well tolerated in all patients, with over 500 doses administered intravenously or by inhalation.
Announced the presentation at the International Society of Heart and Lung Transplant Annual Meeting in April 2018, describing the case of a lung transplant recipient suffering from recurrent episodes of multidrug-resistant Pseudomonas aeruginosa pneumonia who received treatment with bacteriophage therapeutics, including AB-PA01. The patient clinically responded to bacteriophage and antibiotic therapy with resolution of pneumonia and improved respiratory status.
Signed a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans Affairs and a collaboration with the Western Sydney Local Health District and the Westmead Institute for Medical Research covering expanded access to AB-SA01 and AB-PA01 for patients with serious and life-threatening infections unresponsive to antibiotics.
Completed a public offering of 4,000,000 shares of common stock in January 2018, at a price to the public of $1.00 per share, for gross proceeds of $4.0 million and a registered direct offering of common stock in March 2018, at a price of $1.10 per share, for gross proceeds of $3.0 million.
First Quarter 2018 Financial Results

Research and development (R&D) expenses for the first quarter of 2018 and for the first quarter of 2017 were $1.5 million.
General and administrative (G&A) expenses were $1.6 million for the first quarter of 2018 compared to $1.9 million for the first quarter of 2017. The decrease was primarily due to lower legal and professional fees as well as a decrease in non-cash stock-based compensation.
Net cash used in operating activities for the three months ended March 31, 2018 was $3.5 million compared to $3.3 million for the three months ended March 31, 2017.
Cash and cash equivalents as of March 31, 2018 totaled $8.2 million.
As of May 15, 2018, there were 16.5 million shares of common stock outstanding.
Conference Call and Webcast

AmpliPhi will hold a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time). The conference call dial-in number is (866) 652-5200 for domestic callers and (412) 317-6060 for international callers, and the passcode is 10120002. A live webcast of the call will be available on the Investor Relations section of www.ampliphibio.com.

A recording of the call will be available for 48 hours beginning approximately two hours after the completion of the call by dialing (877) 344-7529 for domestic callers and (412) 317-0088 for international callers. Please use passcode 10120002 to access the recording. A webcast replay will be available on the Investor Relations section of www.ampliphibio.com for 30 days, beginning approximately two hours after the completion of the call.

On May 15, 2018 Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, reported results for its third quarter ended March 31, 2018 (Press release, Palatin Technologies, MAY 15, 2018, View Source [SID1234526652]).

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Recent Highlights
Bremelanotide – Under development for Hypoactive Sexual Desire Disorder ("HSDD"):

March 2018 – our exclusive North American licensee for bremelanotide, AMAG Pharmaceuticals, Inc. ("AMAG"), submitted a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for bremelanotide for the treatment of HSDD in premenopausal women.

If approved, bremelanotide would become the first and only as desired pharmacologic option in the U.S. indicated for the treatment of HSDD in premenopausal women.

"The submission of this NDA represents a significant milestone for the bremelanotide clinical program and our efforts to develop a treatment for HSDD," said Carl Spana, Ph.D., CEO and President of Palatin Technologies.

Melanocortin Receptor 1 Agonists ("MC1r") – under development for inflammatory bowel diseases and ocular indications:

May 2018 – Presented positive preclinical MC1r agonist data at TIDES: Oligonucleotide and Peptide Therapeutics 2018 Meeting.

April 2018 – Presented preclinical oral formulation data on PL-8177, an investigational MC1r agonist for Inflammatory Bowel Diseases at the 2018 Keystone Symposia on "The Resolution of Inflammation in Health and Disease."

Phase 1 First-in-Human clinical study of PL-8177 is in progress and on schedule for top line data in the third quarter of calendar year 2018.

Third Quarter Fiscal 2018 Financial Results
Palatin reported a net loss of $(0.7) million, or $(0.00) per basic and diluted share, for the quarter ended March 31, 2018, compared to a net loss of $(3.6) million, or $(0.02) per basic and diluted share, for the same period in 2017.

The difference in financial results between the three months ended March 31, 2018 and 2017 was mainly attributable to the decrease in total operating expenses of $4.3 million that is offset by a decrease of $1.8 million of recognized revenue during the 2018 period pursuant to our license agreement with AMAG.

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Revenue
For the quarter ended March 31, 2018, Palatin recognized $9.0 million in license and contract revenue compared to $10.8 million in the same period in 2017. For both periods, 100% of the revenue Palatin recognized was related to our license agreement with AMAG. As of March 31, 2018, and June 30, 2017, there was $0.6 million and $35.1 million, respectively, of current deferred revenue on the consolidated balance sheet related to this transaction.

Operating Expenses
Total operating expenses for the quarter ended March 31, 2018 were $9.5 million compared to $13.8 million for the same period in 2017. The decrease in operating expenses was mainly attributable to professional services rendered in connection with our license agreement with AMAG, which closed in February 2017, and secondarily to the decrease in development expenses of bremelanotide for HSDD as we continue our progress with our bremelanotide program.

Other Income/Expense
Total other income/expense, net was $0.2 million for the quarter ended March 31, 2018 compared to $0.6 million for the same period in 2017. Total other income/expense, net for both periods consisted primarily of interest expense related to Palatin’s venture debt.

Income Tax
Palatin licensed bremelanotide to Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. ("Fosun") for the People’s Republic of China, Taiwan, Hong Kong and Macau, and to Kwangdong Pharmaceutical Co. Ltd. ("Kwangdong") for the Republic of Korea. Pursuant to the license agreements with Fosun and Kwangdong, $500,000 and $82,500, respectively, was withheld in accordance with tax withholding requirements in China and the Republic of Korea, respectively, and will be recorded as an expense during the fiscal year ending June 30, 2018. For the quarter ended March 31, 2018, Palatin recorded an income tax benefit of $18,746 related to those withholding amounts utilizing an estimated effective annual income tax rate applied to the loss for the quarter and the remaining balance of $275,111 was included in prepaid expenses and other current assets at March 31, 2018. Any potential credit to be received by Palatin on its United States tax returns is currently offset by Palatin’s valuation allowance.

Cash Position
Palatin’s cash, and cash equivalents were $25.7 million as of March 31, 2018, compared to cash, cash equivalents, accounts receivable and investments of $55.6 million at June 30, 2017. Current liabilities were $13.6 million, net of current deferred revenue of $0.6 million, as of March 31, 2018, compared to $19.9 million, net of deferred revenue of $35.1 million, as of June 30, 2017.

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In April 2018, Palatin entered into an equity distribution agreement ("at-the-market program") with Canaccord Genuity LLC, pursuant to which Palatin may, from time to time, sell shares of its common stock at market prices. Palatin has no obligation to sell any shares under this agreement and may, at any time, suspend solicitation and offers under this agreement.

Palatin believes that existing capital resources, together with proceeds from sales of common stock in its at-the-market program (if any), will be sufficient to fund our planned operations through at least June 30, 2019.

CONFERENCE CALL / WEBCAST
Palatin will host a conference call and webcast on May 15, 2018 at 11:00 a.m. Eastern Time to discuss the results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-800-263-0877 (domestic) or 1-323-794-2094 (international), conference ID 1551025. The webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (domestic) or 1-719-457-0820 (international), passcode 1551025. The webcast and telephone replay will be available through May 22, 2018.

On May 15, 2018 Vaxart, Inc. (Nasdaq: VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, reported financial results for the first quarter ended March 31, 2018 and provided a corporate update (Press release, Aviragen Therapeutics, MAY 15, 2018, View Source [SID1234526635]).

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"Since the start of this year, we have made considerable progress advancing our business objectives and progressing our oral vaccine candidates as well as teslexivir for the treatment of condyloma caused by HPV," said Wouter Latour, chief executive officer of Vaxart. "Moreover, with the addition of Dr. David Taylor as our new chief medical officer, we are exceedingly well positioned to execute on the clinical strategy for our oral vaccines. We look forward to continued progress in 2018, with important clinical milestones coming up, including the reporting of topline results from the teslexivir Phase 2 trial in June and the initiation of the norovirus vaccine clinical studies later this year."

First Quarter 2018 and Recent Highlights:

Corporate:

On February 13, 2018, Vaxart closed its merger with publicly traded Aviragen Therapeutics, Inc. The combined public entity is now named Vaxart, Inc., and is traded on the Nasdaq Capital market under the ticker symbol "VXRT." The operations of Aviragen Therapeutics are included in the financial statements from the date of the merger forward.

On April 20, 2018, Vaxart announced it received notification from Daiichi Sankyo Co., Ltd, that sales of Inavir, a single dose product licensed in Japan to prevent or treat influenza infection, exceeded ¥20 billion in the royalty year ending March 31, 2018, triggering a $5 million milestone payment to Vaxart that will be paid in the second quarter of 2018.

On April 19, 2018, Vaxart announced the appointment of Brant Biehn as Senior Vice President, Commercial Operations. Mr. Biehn brings over 27 years of commercial planning, market development and sales experience in the pharmaceutical industry.

On May 1, 2018, Vaxart announced the appointment of David Taylor, M.D., as Chief Medical Officer. Dr. Taylor brings over 35 years of experience in medical research, drug and vaccine development and clinical trial management for government organizations, non-profits, academia and both private and public healthcare companies.

First Quarter 2018 Financial Results:

Vaxart ended the quarter with cash, cash equivalents and short-term investments of $17.5 million compared to $3.0 million at December 31, 2017. The increase was due to cash received from Aviragen upon consummation of the reverse merger on February 13, 2018, offset by cash used in operations.

Revenue for the quarter was $1.5 million compared to $2.3 million in the first quarter of 2017. Revenue from the contract with HHS BARDA decreased $1.7 million as activities are winding down. Royalty revenue from sales of Relenza and Inavir, which were acquired in the merger, amounted to $0.9 million since the date of the merger. Most of the quarter’s royalty revenue, including the $5 million Inavir milestone, was earned prior to the merger and is reflected as $11.1 million in accounts receivable as of March 31, 2018.

Research and development expenses were $3.4 million for the quarter compared to $3.9 million for the first quarter of 2017. The decrease was primarily due to reduced activity under Vaxart’s contract with HHS BARDA, offset by clinical expenses relating to Aviragen’s operations since the date of the merger.

General and administrative expenses were $2.0 million for the first quarter of 2018, compared to $0.7 million for the first quarter of 2017. The increase was primarily due to the additional costs of being a public company, merger-related costs and the overlap of personnel during the transition of operations following the merger.

The excess of the estimated fair value of net assets acquired over the consideration paid for Aviragen resulted in a bargain purchase gain, which is included in the statement of operations. This is a non-cash item..

"Since the start of this year, we have made considerable progress advancing our business objectives and progressing our oral vaccine candidates as well as teslexivir for the treatment of condyloma caused by HPV," said Wouter Latour, chief executive officer of Vaxart. "Moreover, with the addition of Dr. David Taylor as our new chief medical officer, we are exceedingly well positioned to execute on the clinical strategy for our oral vaccines. We look forward to continued progress in 2018, with important clinical milestones coming up, including the reporting of topline results from the teslexivir Phase 2 trial in June and the initiation of the norovirus vaccine clinical studies later this year."

First Quarter 2018 and Recent Highlights:

Corporate:

On February 13, 2018, Vaxart closed its merger with publicly traded Aviragen Therapeutics, Inc. The combined public entity is now named Vaxart, Inc., and is traded on the Nasdaq Capital market under the ticker symbol "VXRT." The operations of Aviragen Therapeutics are included in the financial statements from the date of the merger forward.

On April 20, 2018, Vaxart announced it received notification from Daiichi Sankyo Co., Ltd, that sales of Inavir, a single dose product licensed in Japan to prevent or treat influenza infection, exceeded ¥20 billion in the royalty year ending March 31, 2018, triggering a $5 million milestone payment to Vaxart that will be paid in the second quarter of 2018.

On April 19, 2018, Vaxart announced the appointment of Brant Biehn as Senior Vice President, Commercial Operations. Mr. Biehn brings over 27 years of commercial planning, market development and sales experience in the pharmaceutical industry.

On May 1, 2018, Vaxart announced the appointment of David Taylor, M.D., as Chief Medical Officer. Dr. Taylor brings over 35 years of experience in medical research, drug and vaccine development and clinical trial management for government organizations, non-profits, academia and both private and public healthcare companies.

First Quarter 2018 Financial Results:

Vaxart ended the quarter with cash, cash equivalents and short-term investments of $17.5 million compared to $3.0 million at December 31, 2017. The increase was due to cash received from Aviragen upon consummation of the reverse merger on February 13, 2018, offset by cash used in operations.

Revenue for the quarter was $1.5 million compared to $2.3 million in the first quarter of 2017. Revenue from the contract with HHS BARDA decreased $1.7 million as activities are winding down. Royalty revenue from sales of Relenza and Inavir, which were acquired in the merger, amounted to $0.9 million since the date of the merger. Most of the quarter’s royalty revenue, including the $5 million Inavir milestone, was earned prior to the merger and is reflected as $11.1 million in accounts receivable as of March 31, 2018.

Research and development expenses were $3.4 million for the quarter compared to $3.9 million for the first quarter of 2017. The decrease was primarily due to reduced activity under Vaxart’s contract with HHS BARDA, offset by clinical expenses relating to Aviragen’s operations since the date of the merger.

General and administrative expenses were $2.0 million for the first quarter of 2018, compared to $0.7 million for the first quarter of 2017. The increase was primarily due to the additional costs of being a public company, merger-related costs and the overlap of personnel during the transition of operations following the merger.

The excess of the estimated fair value of net assets acquired over the consideration paid for Aviragen resulted in a bargain purchase gain, which is included in the statement of operations. This is a non-cash item.

On May 15, 2018 Personalis, Inc., a provider of advanced genomic sequencing and analytics for immuno-oncology, reported that the State Intellectual Property Office of China has issued patent ZL 2013 8 00748247 for the ACE© Technology Platform (Press release, Personalis, MAY 15, 2018, View Source [SID1234526653]). This is the latest patent issued to Personalis for ACE Technology, following US Patent approval in 2013, and UK Patent approval in 2016. This proprietary technology includes systems and methods for the comprehensive and accurate genomic analysis of tumors, and forms the basis of all Personalis products, including ACE ImmunoID.

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ACE Technology overcomes limitations associated with conventional exome and transcriptome sequencing assays to provide increased assay sensitivity and deeper, more uniform coverage of notoriously difficult-to-sequence genomic regions (Patwardhan et al., Genome Med. 2015; 7:71). The technology improves processes from nucleic acid extraction, to sample preparation and sequencing, to alignment and variant discovery analysis. This allows for the accurate and precise capture of genetic variants including single nucleotide variants and indels from DNA, as well as fusions from RNA.

For immuno-oncology applications such as biomarker discovery and neoantigen identification, Personalis developed its leading immunogenomics platform, ACE ImmunoID, with ACE Technology at its core for enhanced sequencing and analytical performance. ACE ImmunoID uses augmented whole exome and transcriptome assays to provide comprehensive genomic profiling of the tumor, its microenvironment, and tumor-specific neoantigens to help biopharmaceutical companies develop personalized cancer immunotherapies.

"Since its inception, Personalis has recognized the international potential of our advanced genomics technology," said Personalis CEO, John West. "We established our first foreign subsidiary in 2013 and have now served customers in seventeen countries. In parallel with this, we have built a broadly international intellectual property base and are now gratified to see it expanding further with this issuance in China."

On May 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 first quarter 2018 (Press release, Athenex, MAY 14, 2018, View Source;p=RssLanding&cat=news&id=2348822 [SID1234526557]).

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Dr. Johnson Lau, Athenex’s Chief Executive Officer, stated, "Our strong performance in the first quarter of 2018 reflects the continued positive momentum generated by our clinical programs and commercial efforts in our first year as a public company. In addition to the positive feedback from the FDA on the Phase III Clinical Study design for Oraxol, our rapid patient recruitment rate for our KX2-391 Ointment Phase III clinical trials is encouraging and puts us on track to announce topline data for these studies in the third quarter of 2018. Additionally, our landmark strategic partnership with Almirall and our commercial platform allowed us to generate record revenues during the first quarter, thus reinforcing our confidence in achieving our revenue guidance for 2018."

Dr. Lau continued, "In addition to these first quarter highlights, we recently announced the FDA has granted us Orphan Drug Designation for Oraxol for the treatment of angiosarcoma, a rare form of malignant blood vessel cancer. This further validates the strategy for the development of Oraxol and is a testament to the quality of our global team. As we move in to the balance of 2018, we are very excited by the multitude of growth opportunities across our platform and look forward to achieving the milestones in our business that will create value for all of our stakeholders."

First Quarter 2018 and Recent Business Highlights:

Clinical Platforms:

Orascovery:
Received Orphan Drug Designation from the US FDA for Oraxol in angiosarcoma, a rare form of malignant blood vessel cancer
Met and exceeded enrollment target for Oraxol Phase III Clinical Trial in metastatic breast cancer and announced positive feedback from the FDA regarding the trial design;
Obtained IND approval for Oraxol from the Chinese FDA to begin clinical trials in China;
Completed the first cohort of patients in its Phase 1b clinical trial of Oraxol (oral paclitaxel) plus CYRAMZA (ramucirumab) in gastric cancer patients who failed previous chemotherapies;

Src Kinase Inhibition
Completed patient enrollment for both Phase III clinical studies of KX2-391 Ointment for actinic keratosis indications months ahead of schedule; and
Phase II clinical study data for KX2-391 Ointment for the treatment of actinic keratosis was presented at the American Academy of Dermatology Annual Meeting (abstract ID 6134).
Commercial Business:

Launched 8 new products during the first quarter;
Athenex Pharmaceutical Division ("APD") currently markets 19 products in the U.S. with 32 SKUs; and
Athenex Pharma Solutions ("APS"), our 503(b) outsourced facility, currently markets 5 products with 23 SKUs.
First Quarter 2018 Financial Results:

Revenue for the three months ended March 31, 2018 was $37.8 million, an increase of $33.2 million, as compared to $4.6 million for the three months ended March 31, 2017. The increase was primarily attributable to $25.0 million in upfront license fees related to the collaboration agreement with Almirall, S.A., $8.6 million specialty products sold through our Commercial Platform, and $0.4 million in the sales of our 503B products. This was offset by decreases in other out-licensing fees of $0.5 million, contract manufacturing revenue of $0.2 million and API and medical device sales of $0.1 million.

Cost of product sales for the three months ended March 31, 2018 totaled $11.3 million, an increase of $8.5 million, as compared to $2.8 million for the three months ended March 31, 2017. This was primarily due to the increase of $7.2 million cost of product sales from the recently launched specialty products and $1.3 million cost of product sales from 503B and API products. The decrease in gross profit was primarily due to the impact of the costs incurred for the scale-up of production for new products in our 503B outsourcing facility.

Research and development expenses for the three months ended March 31, 2018 totaled $21.3 million, a decrease of $5.1 million, as compared to $26.4 million for the three months ended March 31, 2017. This was primarily due to $14.4 million decreased of drug licensing fees to Hanmi and Gland and offset by $6.9 million increase of clinical study costs for Phase III trials of Oraxol and KX-01 Ointment, $1.0 million increase of compensation expenses, $0.9 million increase of product development and supplies related to 503B products and $0.5 million increase in preclinical studies and API R&D expenses.

Selling, general and administrative expenses for the three months ended March 31, 2018, totaled $13.1 million, an increase of $3.3 million, as compared to $9.8 million for the three months ended March 31, 2017. The increase was primarily due to a $1.4 million increase of compensation expenses, $1.4 million increase of office expenses and professional fees and a $0.5 million increase of sales and marketing costs related to the launch of our proprietary products.

For the three months ended March 31, 2018, the Company incurred a net loss of $7.3 million compared to a net loss of $41.0 million a year ago.

Cash and cash equivalents and short-term investments totaled $106.5 million as of March 31, 2018, compared to $51.0 million as of December 31, 2017. This increase was due to an underwritten public offering of 4,765,000 shares of common stock in the first quarter of 2018, pursuant to which the Company raised net proceeds of $68.1 million, net of underwriting discounts, commissions and offering expenses and an upfront license fee payment of $30 million from Almirall. The Company believes that its existing cash and cash equivalents and short-term investments will be sufficient to fund current operating plans through approximately early-2019.

Outlook and Upcoming Milestones:

Clinical Platforms:

The enrollment of patients for Oraxol Phase III Clinical Trial is on target for the Company to be able to conduct a second interim analysis in the Oraxol KX-ORAX-001 Phase III clinical trial in the third quarter of 2018.
Expect topline data for Phase III KX2-391 Ointment studies to be available in the third quarter of 2018.

Commercial Business:

Full-year 2018 revenue in the range of $100 million to $125 million, inclusive of licensing-fee revenue associated with the partnership agreement with Almirall.
Corporate Updates:

Expect Dunkirk facility construction to be completed by the first quarter of 2019.
Conference Call and Webcast Information:

The Company will host a conference call and audio webcast on Monday, May 14, 2018 at 9:00 a.m. Eastern Time. To participate in the call, dial (855) 227-0567 (domestic) or (612) 979-9912 (international) fifteen minutes before the conference call begins and reference the conference passcode 9093904. A replay will be available approximately one hour after the recording through Monday, May 21, 2018 and can be accessed by dialing (855) 859-2056. 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. An archive will be available at this website until June 14, 2018.