On November 14, 2018 Agilent Technologies Inc. (NYSE: A) reported it has completed the acquisition of ACEA Biosciences Inc. (ACEA), a developer of cutting-edge cell analysis tools, for $250 million in cash (Press release, Agilent, NOV 14, 2018, View Source [SID1234531314]). This acquisition brings together two pioneers in cellular function and metabolism measurements focused on real-time, live cell analyses.

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!

ACEA has developed two ground-breaking platforms that are complementary to Agilent’s current portfolio. The ACEA xCELLigence RTCA technology is a unique impedance platform for label-free, real-time cellular function measurements used in immuno-oncology, pre-clinical drug discovery and development, as well as in basic academic research. This technology is complemented by the introduction in recent years of the NovoCyte and NovoCyte Quanteon portfolio of high performance bench top flow cytometry systems.

ACEA also markets a clinical configuration of the NovoCyte platform, currently commercialized in China. This provides a unique opportunity in combination with Agilent’s Reagent Partnership business within Agilent’s Diagnostics and Genomics Group which provides reagents for flow cytometry.

"The Agilent and ACEA teams are united by a common goal to provide the most innovative high-performance solutions for cell analysis," said Todd Christian, Vice President & General Manager of Agilent’s Cell Analysis Division. "We are excited for the opportunities we have as a newly combined team to provide the most advanced tools for scientists performing cell analysis workflows."

ACEA is Agilent’s second acquisition this year in the cell analysis space. In January, Agilent acquired Luxcel Biosciences, a developer of real-time fluorescence plate-reader based in vitro cell assay kits. Cell analysis is a key area of strategic focus for Agilent.

ACEA was founded in 2002 and has its headquarters in San Diego and a large manufacturing and R&D footprint in Hangzhou, China. More than 2,500 ACEA instruments have been placed globally and have been used in more than 1,800 peer-reviewed publications.

On November 14, 2018 Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage biopharmaceutical company developing innovative therapies to improve outcomes in cancers that are difficult to treat, reported that Douglas J. Swirsky, who has served as Rexahn’s president and chief financial officer since January 2018, has been named the company’s president and chief executive officer and appointed to the company’s board of directors effective immediately (Press release, Rexahn, NOV 14, 2018, View Source [SID1234531477]). Peter D. Suzdak, Ph.D., chief executive officer, has departed the company and resigned as a member of its board of directors.

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!

"On behalf of the board and everyone at Rexahn, I want to thank Peter Suzdak for his contributions to the company over the past six years," said Peter Brandt, chairman of the board of directors. "The board is confident that Doug has the experience and creativity to deliver on the promise of Rexahn’s innovative pipeline and lead the company forward through substantial value-creating milestones."

"I am excited about the future of Rexahn and believe significant opportunities exist to transform Rexahn into an industry-leading, cancer-focused company. I look forward to working with the board, the executive team and all stakeholders to achieve this goal," said Mr. Swirsky.

Prior to joining Rexahn, Mr. Swirsky was CEO and a director of GenVec, Inc., a publicly traded biotechnology company, a position he held from 2013 through the sale of the company in 2017. He also served as GenVec’s CFO from 2006 until he assumed the role of CEO in 2013. Prior to joining GenVec, Mr. Swirsky was a managing director and the head of life sciences investment banking at Stifel Nicolaus from 2005 to 2006 and held investment banking positions at Legg Mason from 2002 until Stifel Financial’s acquisition of the Legg Mason Capital Markets business in 2005. He has also previously held investment banking positions at UBS, PaineWebber and Morgan Stanley. Mr. Swirsky currently serves on the board of directors of Fibrocell Science, Inc., Cellectar Biosciences, Inc. and Pernix Therapeutics Holdings, Inc. He is a certified public accountant and a CFA charter holder. He received his B.S. in Business Administration from Boston University and his M.B.A. from the Kellogg School of Management at Northwestern University.

Mr. Swirsky will also continue to serve as the company’s principal financial officer.

On November 14, 2018 On November 9, 2018, Adhera Therapeutics, Inc. (the "Company") entered into Subscription Agreements (the "Purchase Agreements") with certain accredited investors and conducted a closing pursuant to which the Company sold 73 shares of the Company’s Series F convertible preferred stock, par value of $0.01 per share (the "Preferred Stock"), at a purchase price of $5,000 per share of Preferred Stock (Filing, 8-K, Marina Biotech, NOV 14, 2018, View Source [SID1234531299]). Each share of Preferred Stock is initially convertible into shares of the Company’s common stock, par value $0.006 per share (the "Common Stock"), at a conversion price of $0.50 per share of Common Stock. In addition, each investor received a 5-year warrant (the "Warrants", and collectively with the Preferred Stock, the "Securities", and the offering of the Securities, the "Private Placement") to purchase 0.75 shares of Common Stock for each share of Common Stock issuable upon the conversion of the Preferred Stock purchased by such investor at an exercise price equal to $0.55 per share of Common Stock, subject to adjustment thereunder.

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 Company received total net proceeds of approximately $0.31 million from the issuance of the Securities described above, after deducting placement agent fees and estimated expenses payable by the Company associated with such closing. The Company intends to use the proceeds of the Private Placement to fund its commercial operations relating to the sale and promotion of the Company’s Prestalia product and the potential acquisition of additional commercial assets. Prestalia is a single-pill fixed dose combination of perindopril arginine, an angiotensin-converting-enzyme inhibitor, and amlodipine besylate, a calcium channel blocker, which has been approved by the U.S. Food and Drug Administration and is actively marketed in the U.S.

The Securities were being offered and sold in a private placement pursuant to exemptions from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), afforded by Section 4(a)(2) and Rule 506(b) of Regulation D promulgated thereunder. To the extent that any shares of Common Stock are issued in connection with the conversion of the Preferred Stock or the exercise of the Warrants, the Common Stock may not be offered, transferred or sold in the United States absent registration or the availability of an applicable exemption from the registration requirements of the Securities Act.

The rights, preferences and privileges of the Preferred Stock are set forth in a Certificate of Designation of Preferences, Rights and Limitations of the Series F Convertible Preferred Stock of Adhera Therapeutics, Inc. (the "Certificate of Designation") that was filed with the Secretary of State of the State of Delaware on July 11, 2018. The Certificate of Designation was filed as Exhibit 3.1 to the Current Report on Form 8-K that the Company filed with the Securities and Exchange Commission on July 16, 2018 (the "July 8-K"), and the rights, preferences and privileges of the Preferred Stock were summarized in the July 8-K. The form of Warrant that was issued at the Closing was filed as Exhibit 4.1 to the July 8-K, and the terms and provisions thereof were summarized in the July 8-K.

The foregoing summaries of the material terms and provisions of the Certificate of Designation and the form of Warrant are not complete and are qualified in their entirety by reference to the full text thereof, copies of each of which are filed herewith as Exhibits 3.1 and 4.1, respectively, and incorporated by reference herein.

On November 14, 2018 Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported it initiated patient dosing in a Phase 1 clinical trial of FPT155, a first-in-class CD80 fusion protein (Press release, Five Prime Therapeutics, NOV 14, 2018, View Source [SID1234531315]). The trial was initiated in Australia.

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!

"We are pleased to initiate patient dosing for FPT155, our first-in-class CD80-Fc fusion protein, which is engineered to activate T cells through multiple pathways," said Helen Collins, M.D., Senior Vice President and Chief Medical Officer of Five Prime. "In vivo, FPT155 demonstrates strong single-agent activity in multiple preclinical models, including some that are generally resistant to immune-modulating therapy. We look forward to testing FPT155 in the clinic to see if it has the potential to improve outcomes across multiple tumor indications where new treatment options are needed."

"FPT155 is further evidence of Five Prime executing on the strategy of leveraging our IND engine as a source of competitive advantage in developing first-in-class agents that have the potential to demonstrate single-agent activity or activity in tumors that typically do not respond to checkpoint inhibitors," said Aron Knickerbocker, Chief Executive Officer of Five Prime Therapeutics. "Beyond FPT155, this strategy can be seen across our robust pipeline, including with cabiralizumab, bemarituzumab and FPA150. These drug candidates target or engage multiple cells in the tumor microenvironment, including tumor cells, effector T cells, macrophages and NK cells."

The Phase 1a/1b open-label, multicenter, dose escalation, dose exploration and dose expansion study will evaluate the safety and tolerability of FPT155 in patients with advanced solid tumors. The Phase 1a dose escalation portion of the trial will characterize the safety and pharmacokinetic (PK)/pharmacodynamic (PD) profile of FPT155 and will identify a recommended dose for the Phase 1b portion of the trial. During the dose escalation, Five Prime will also open an exploratory cohort to investigate FPT155 monotherapy in select tumor types with high unmet need. The Phase 1b portion of the trial is intended to further characterize the safety, PK/PD profile, and preliminary efficacy of FPT155.

About FPT155

FPT155 is a first-in-class CD80 fusion protein that (i) directly engages CD28 to enhance its co-stimulatory T-cell activation activity without inducing super agonism, and (ii) blocks CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T-cell activation in the tumor microenvironment. FPT155 has also demonstrated its ability to retain anti-tumor activity independent of its engagement with CTLA-4, suggesting a differentiated mechanism of action from CTLA-4-blocking antibodies. Studies in preclinical models suggest FPT155 has the potential to be a potent T-cell co-stimulator with strong monotherapy anti-tumor activity.

On November 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 nine-months ended September 30, 2018 (Press release, Athenex, NOV 14, 2018, View Source;p=RssLanding&cat=news&id=2377084 [SID1234531432]).

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!

"We achieved continued positive momentum at Athenex in the third quarter in our strategy to build a global biopharmaceutical business and to create more effective, safer and tolerable treatments for cancer patients," stated Dr. Johnson Lau, Chief Executive Officer of Athenex. "Our Phase III Oraxol program reached an important milestone with the second positive DSMB review in September and we remain on track to complete enrollment and report data from this study in 2019. We also continue to make progress with other drug candidates in our Orascovery platform, with Oratecan and Oradoxel ready to advance to Phase II studies. The addition of the cellular immunotherapy and biologic platforms have expanded our oncology-focused product pipeline. For KX2-391, the most advanced candidate in our Src kinase program, we are working with our partner Almirall on developing a commercial plan for this product."

Third Quarter 2018 and Recent Business Highlights:

Clinical Platforms:

Announced that the Data and Safety Monitoring Board (DSMB) overseeing the Company’s ongoing randomized, controlled Phase III trial of Oraxol in metastatic breast cancer recommended unanimously that the study continue as planned. The DSMB also congratulated the Company on the rapid patient recruitment and promising results achieved.

Presented updated encouraging efficacy and safety data of Oraxol in the treatment of metastatic breast cancer patients who had failed previous chemotherapies in a pharmacokinetics (PK) and Phase II study conducted in Taiwan at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Munich, Germany.

Announced acceptance of an Investigational New Drug (IND) application for Eribulin ORA, Athenex’s oral version of Eribulin. Initiation of clinical trials is currently planned for the first half of 2019. This is the eighth US IND allowance that Athenex has obtained.

Identified suitable dosing regimens of Oratecan and Oradoxel for advancement into Phase II studies, based on recent PK data.

Announced positive results from pilot studies conducted in China by Xiangxue Life Sciences in end-stage cancer patients who were treated with T-cell receptor affinity enhancing specific T-cell therapy (TAEST), a form of cancer immunotherapy. Axis Therapeutics Limited, a joint venture between Athenex and Xiangxue Life Sciences established in September 2018, owns the worldwide (excluding China) rights to research, develop and commercialize T-cell receptor-engineered T cells (TCR-T), including TAEST technology.

Announced positive data from two Phase III pivotal efficacy studies of KX2-391 in the treatment of actinic keratosis (AK).
Commercial Business

Developed detailed launch plans for Oraxol and KX2-391.

Athenex Pharmaceutical Division ("APD") currently markets a total of 25 products with 48 SKUs and is planning to launch 2 new products before year end with 4 additional new SKUs.

Athenex Pharma Solutions ("APS") currently markets 6 products in total with 16 SKUs.
Corporate and Strategic Highlights:

Promoted Mr. Randoll Sze to Chief Financial Officer.

Announced a strategic realignment of joint projects between Athenex and its collaborative partner, Hanmi Pharmaceutical.
Third Quarter 2018 Financial Results:

Revenue for the three months ended September 30, 2018 was $18.4 million, an increase of $4.4 million, or 32%, as compared to $14.0 million for the three months ended September 30, 2017. The increase was primarily attributable to an increase in licensing revenue of $5.0 million, a $1.0 million increase in sales of the Company’s 503B products, and a $0.8 million increase in medical device sales. This was offset by decreases in API sales of $1.7 million, contract manufacturing revenue of $0.2 million, grant revenue of $0.2 million, and other product sales of $0.2 million.

Cost of sales for the three months ended September 30, 2018 totaled $12.0 million, an increase of $3.9 million, or 48%, as compared to $8.1 million for the three months ended September 30, 2017. This was primarily due to the increase of $1.9 million cost of sales from the recently launched specialty products and $2.0 million cost of sales from 503B and API products. The increase in gross profit was primarily due to the licensing revenue in the current year.

Research and development expenses for the three months ended September 30, 2018 totaled $51.2 million, an increase of $39.3 million, or 329%, as compared to $11.9 million for the three months ended September 30, 2017. This was primarily due to an increase in licensing fees and clinical expenses. In particular, there was a $29.5 million non-cash license fee related to the purchase of TCR-T in connection with the establishment of Axis Therapeutics, of which $24.5 million related to the fair value of the IPR&D and $5.0 million related to the Company’s common stock issued to Xiangxue Life Sciences.

SG&A expenses for the three months ended September 30, 2018 totaled $11.5 million, an increase of $1.1 million, or 11%, as compared to $10.4 million for the three months ended September 30, 2017. This was primarily due to an increase in professional fees of $0.9 million from legal fees incurred in conjunction with the launch of 503B products and an increase in employee compensation of $0.5 million, offset by a decrease of $0.3 million in selling and marketing expenses related to the launch of specialty products.

Net loss attributable to Athenex for the third quarter ended September 30, 2018 was $46.2 million, or ($0.70) per diluted share, compared to a net loss of $23.3 million, or ($0.41) per diluted share, in the same period last year. Excluding the non-cash license fee of $24.5 million, the net loss attributable to Athenex for the third quarter ended September 30, 2018 was $21.6 million.

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.

Cash, cash equivalents and short-term investments were $141.4 million at September 30, 2018, compared to $51.0 million at December 31, 2017. Based on the current operating plan, the Company expects that its cash, cash equivalents and short-term investments as of September 30, 2018, together with cash to be generated from operating activities, will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2019.

Nine Months Ended September 30, 2018 Financial Results:

Revenue for the nine months ended September 30, 2018 was $67.8 million, an increase of $44.7 million, or 193%, as compared to $23.2 million for the nine months ended September 30, 2017. The increase was primarily attributable to $30.0 million in upfront license fees, a $13.7 million increase in specialty products sold through the Company’s Commercial Platform, a $2.0 million increase in sales of 503B products, and a $0.4 million increase in API and medical device sales.

Cost of sales for the nine months ended September 30, 2018 totaled $32.7 million, an increase of $17.6 million, or 117%, as compared to $15.1 million for the nine months ended September 30, 2017. This was primarily due to the increase of $13.2 million cost of sales from the specialty products and $4.4 million cost of sales from 503B and API products.

Research and development expenses for the nine months ended September 30, 2018 totaled $99.1 million, an increase of $43.1 million, or 77%, as compared to $55.9 million for the nine months ended September 30, 2017. This was primarily due to an increase in licensing fees and clinical expenses. In particular, there was a $29.5 million non-cash license fee related to the purchase of TCR-T in connection with the establishment of Axis Therapeutics, of which $24.5 million related to the fair value of the IPR&D and $5.0 million related to the Company’s common stock issued to Xiangxue Life Sciences.

SG&A expenses for the nine months ended September 30, 2018 totaled $37.4 million, an increase of $3.6 million, or 11%, as compared to $33.8 million for the nine months ended September 30, 2017. This was primarily due to an increase in costs related to operating as a public company.

Net loss attributable to Athenex for the nine months ended September 30, 2018 was $90.3 million, or ($1.42) per diluted share, compared to a net loss of $102.9 million, or ($2.18) per diluted share, for the nine months ended September 30, 2017. Excluding the non-cash license fee of $24.5 million, the net loss attributable to Athenex for the nine months ended September 30, 2018 was $65.8 million.

Outlook and Upcoming Milestones:

Due to the timing of a collaborative payment from a partner, the Company currently expects its full year 2018 revenue to be in the lower end of the guidance range of $100 million to $125 million, inclusive of licensing-fee revenue. The operational business is on track and the Company expects to receive the collaborative payment in the first half of 2019.

Clinical Platforms:

12 month follow-up data from KX2-391 Phase III studies for the treatment of AK are expected in the second quarter of 2019.
Oraxol Phase III clinical trial in metastatic breast cancer is expected to complete target enrollment by the end of 2018, with top line data expected in mid-2019.
Oratecan and Oradoxel Phase II studies are expected to initiate in the first half of 2019.
Expect to file INDs for TCR-T candidates and Pegtomarginase by mid-2019.
Corporate Updates:

The Company will be hosting a Research and Development Day for the investment community on December 17, 2018 to provide an update on its major clinical programs.
The exterior of the Dunkirk facility is expected to be completed by the first half of 2019. The facility is expected to be completed by the end of 2019 and operational in mid-2020.
Construction of the Chongqing API plant is expected to be completed by the end of 2018, with completion of the facility expected by mid-2019.
Construction of the Chongqing dosage plant is expected to break ground in the first half of 2019.
Conference Call and Webcast Information:

The Company will host a conference call and live audio webcast today, Wednesday, November 14, 2018 at 8:00 a.m. Eastern Time to discuss the financial results and provide a business update.

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 13683946.

To join the webcast, click on View Source

A replay of the call will be accessible two hours after its completion through November 21 by dialing 844-512-2921 (in the U.S.) or 412-317-6671 (outside the U.S.) and entering passcode 13683946. The live conference call and replay can also be accessed via audio webcast on the Investor Relations section of the Company’s website, located at www.athenex.com.