On August 8, 2018 Novavax, Inc. (Nasdaq: NVAX) reported its financial results and operational highlights for the second quarter and six months ended June 30, 2018 (Press release, Novavax, AUG 8, 2018, View Source [SID1234528543]).

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"In keeping with our stated 2018 objectives, Novavax reached two important milestones in the second quarter for our lead ResVax and NanoFlu programs," said Stanley C. Erck, Novavax President and CEO. "With ResVax, we achieved a critical enrollment goal in the Prepare trial, enabling us to reach agreement with the FDA to initiate a final efficacy analysis in the first quarter of 2019. This analysis will be used to support the future BLA and MAA in the U.S. and Europe, respectively."

"On the NanoFlu front," Mr. Erck continued, "the data published in The New England Journal of Medicine demonstrated that NanoFlu induced significantly improved immune response compared to the current leading high-dose influenza vaccine. We are on track to initiate a Phase 2 clinical trial of quadrivalent formulations of NanoFlu in the third quarter of this year. Pending successful Phase 2 data, based on discussions with the FDA, we anticipate initiating a Phase 3 immunogenicity clinical trial that may provide the basis of licensure via the FDA’s accelerated approval pathway."

Operational Highlights:

ResVax Program

In May 2018, Novavax’ Prepare trial reached enrollment of 4,636 pregnant women, at least 3,000 of whom received ResVax.

Novavax recently reached agreement with the FDA that the efficacy analysis to be conducted in the first quarter of 2019 will be the final analysis used to support the future biologics license application (BLA). This agreement was based on meeting the FDA’s minimum standards for evaluation of both the safety and efficacy of ResVax. We anticipate using the same data for filing a marketing authorization application (MAA) submission in Europe. The current and projected numbers of blinded primary endpoint cases provide Novavax with confidence that the trial is powered to make a statistically sound efficacy conclusion. Novavax expects to report on these data in the first quarter of 2019 and, assuming successful results, expects to submit the BLA and the MAA by the first quarter of 2020.
NanoFlu Program

In June 2018, The New England Journal of Medicine published a peer-reviewed letter to the editor detailing the positive results from Novavax’ Phase 1/2 clinical trial in older adults of NanoFlu compared to the leading licensed egg-based, high-dose influenza vaccine. Novavax had previously presented top-line results from this clinical trial at the World Vaccine Congress in April 2018.

In June 2018, the FDA acknowledged and agreed that the accelerated approval pathway for seasonal influenza vaccines could be available for NanoFlu.
Corporate

In April 2018, Novavax conducted a public offering of approximately 34.8 million shares of its common stock, resulting in net proceeds of $54 million.
Anticipated Events:

Final efficacy results of the Prepare trial are expected in the first quarter of 2019.

The Phase 2 clinical trial of quadrivalent formulations of NanoFlu is expected to begin in the third quarter of 2018.

Top-line data from the Phase 2 clinical trial of NanoFlu and End of Phase 2 meeting with the FDA are expected in the first quarter of 2019.
Financial Results for the Three and Six Months Ended June 30, 2018

Novavax reported a net loss of $44.5 million, or $0.12 per share, for the second quarter of 2018, compared to a net loss of $44.5 million, or $0.16 per share, for the second quarter of 2017. For the six months ended June 30, 2018, the net loss was $90.8 million, or $0.25 per share, compared to a net loss of $88.3 million, or $0.32 per share, for the same period in 2017.

Novavax revenue in the second quarter of 2018 was $10.8 million, compared to $6.7 million in the same period in 2017. This 60% increase was driven by higher revenue recorded under the Bill & Melinda Gates Foundation (BMGF) grant of $89 million as a result of increased enrollment in the Prepare trial and increased activities of Novavax AB, a wholly owned subsidiary of Novavax.

Research and development expenses increased 13% to $44.5 million in the second quarter of 2018, compared to $39.3 million for the same period in 2017. The increase was primarily due to increased development activities of ResVax.

General and administrative expenses decreased 8% to $8.2 million in the second quarter of 2018, compared to $8.9 million for the same period in 2017. The decrease was primarily due to lower employee-related costs.

Interest income (expense), net for the second quarter of 2018 was ($2.6) million, compared to ($3.0) million for the same period of 2017.

As of June 30, 2018, Novavax had $178.2 million in cash, cash equivalents, marketable securities and restricted cash, compared to $186.4 million as of December 31, 2017. Net cash used in operating activities for the second quarter of 2018 was $40.0 million, compared to $12.4 million for same period in 2017. The increase in cash usage was primarily due to the receipt of a $25 million payment under the BMGF grant in the six months ended June 30, 2017, whereas no payment was received in the same period of 2018 (however, we expect to receive a $15 million payment in the third quarter of 2018).

Conference Call

Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in number for the conference call is (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 5886748. A replay of the conference call will be available starting at 7:30 p.m. ET on August 8, 2018 until 7:30 pm ET on August 15, 2018. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 5886748.

A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "Investor Info"/"Events" tab on the Novavax website. A replay of the webcast will be available on the Novavax website until November 8, 2018.

About RSV in infants

RSV (respiratory syncytial virus) is the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. Estimated annual infections of 64 million and an estimated 160,000 deaths make it the second leading cause of death in children under one year of age. RSV results in a total global economic burden of $6.2 billion annually. In the U.S., RSV is the leading cause of hospitalization of infants. While RSV can impact all infants, babies under six months of age are among those at highest risk, as approximately 77% of all first-year RSV infections occur before six months. In the U.S., the total economic burden is $2.7 billion annually.

About ResVax

ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate. It is being developed to protect infants from RSV disease via maternal immunization and is the only RSV vaccine in a Phase 3 clinical trial for this indication. Protecting infants via maternal immunization has been shown to be effective against influenza, another respiratory virus, in prospective clinical studies. In addition, maternal immunization with tetanus and pertussis vaccines has been shown to be effective in preventing these diseases in infants. Maternal immunization may offer the best method of protection from RSV disease in infants through the first months of life.

Currently, ResVax is being evaluated in Prepare, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom have received the vaccine, and their infants. Prepare is supported by an $89.1 million grant from the Bill & Melinda Gates Foundation (BMGF).

About Influenza

Influenza is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death. Serious illness occurs not only in susceptible populations such as infants, young children and older adults, but also in the general population largely because of infection by continuously evolving strains of influenza which can evade the existing protective antibodies in humans. An estimated one million deaths globally each year are attributed to influenza.1 Current estimates for seasonal influenza vaccine growth in the top seven markets (U.S., Japan, France, Germany, Italy, Spain and UK), show a potential increase from approximately $3.2 billion in 2015 to $5.3 billion by 2025.2

About NanoFlu and Matrix-M

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes. Novavax expects to begin a Phase 2 for its quadrivalent NanoFlu clinical trial in the third quarter of 2018.

About Accelerated Approval

Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments. Such an approval will be based on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. For seasonal influenza vaccines, the hemagglutination inhibition (HAI) antibody response may be an acceptable surrogate marker of activity that is reasonably likely to predict clinical benefit. To be considered for accelerated approval, a BLA for a new seasonal influenza vaccine should include results from one or more well-controlled studies designed to meet immunogenicity endpoints and a commitment to conduct confirmatory post-marketing studies of clinical effectiveness in preventing influenza.

On August 8, 2018 Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported financial results for the second quarter ended June 30, 2018 and provided a corporate update (Press release, Selecta Biosciences, AUG 8, 2018, View Source [SID1234528542]).

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"The continued improvement in clinical activity observed in the expanded patient data set recently presented at the EULAR conference in June further demonstrates the benefit SEL-212 may provide to chronic severe gout patients and its potential ability to change the current treatment paradigm in these patients with high medical need," said Werner Cautreels, Ph.D., President and CEO of Selecta. "We look forward to presenting data from patients receiving five monthly doses of SEL-212 at the upcoming ACR meeting in October and expect to initiate the Phase 3 program for SEL-212 in the fourth quarter of this year. In addition, we plan to conduct a head-to-head clinical trial against Krystexxa in parallel with our Phase 3 program."

Recent Highlights and Anticipated Upcoming Milestones

Presented New Expansion Data from Ongoing Phase 2 Trial of SEL-212 at the European League Against Rheumatism (EULAR) 2018 in June: In June 2018, Selecta presented new expansion data from patients receiving SEL-212 for the treatment of chronic severe gout at EULAR 2018 in Amsterdam, the Netherlands. The data was from patients receiving three monthly doses of SEL-212, up to 0.15 mg/kg of SVP-Rapamycin in combination with 0.2 or 0.4 mg/kg of pegsiticase, followed by two monthly doses of pegsiticase alone. Approximately 80% of evaluable patients (n=27) had serum uric acid control below 6 mg/dl at week 12. In a separately conducted and designed study of the only FDA-approved uricase therapy, 44% of evaluable patients had serum uric acid control below 6 mg/dl at week 16.33% of the patient population represented by our EULAR data, and only 27% of all current patients in the SEL-212 Phase 2 trial, experienced gout flares during the first month after treatment with continued reduction of gout flare rates over months two to five. This reduced rate of gout flares appears to be substantially lower than the incidence of gout flares reported in clinical trials involving the current FDA-approved uricase and other uric acid lowering therapies.

Data from Cohorts Receiving Five Combination Doses in Ongoing Phase 2 Trial of SEL-212 to be Presented at the ACR Annual Meeting scheduled for October 19-24, 2018: The company expects to present data from new cohorts of patients in the ongoing Phase 2 trial who are receiving five monthly doses of SVP-Rapamycin in combination with pegsiticase at the upcoming ACR meeting scheduled for October 19-24, 2018. These patients are receiving SVP-Rapamycin doses ranging from 0.10 – 0.15mg/kg in combination with 0.2mg/kg of pegsiticase.

Active Preparations Underway for SEL-212 Phase 3 Clinical Program and Expected Initiation of Patient Enrollment in Fourth Quarter of 2018:Selecta is actively preparing for the start of a pivotal Phase 3 program for SEL-212, and plans to initiate patient enrollment in the fourth quarter of 2018 in a couple of clinical trial sites. The company expects to evaluate maintenance of serum uric acid control below 6 mg/dl at month three and month six as the primary clinical endpoint in two placebo-controlled clinical trials. The company’s end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) will define the company’s design for the Phase 3 program.

Active Preparations Underway for Head-to-Head Trial of SEL-212 Versus the Current FDA-Approved Uricase Therapy, Krystexxa: The company is actively preparing to start a head-to-head clinical trial of SEL-212 compared to the current FDA-approved uricase therapy, Krystexxa, which will be designed to have the potential to demonstrate superiority. Selecta plans to initiate this trial in parallel with the Phase 3 program and expects to report clinical data at both the three month and six month time points in 2019.

Patient Enrollment Ongoing for SEL-403 Phase 1 Trial for Mesothelioma: The company is actively dosing patients in an open-label dose-finding Phase 1 clinical trial of SEL-403, Selecta’s combination product candidate consisting of SVP-Rapamycin and LMB-100, for the treatment of patients with malignant pleural or peritoneal mesothelioma who have undergone at least one regimen of chemotherapy. The trial is being conducted in cooperation with the National Cancer Institute (NCI), part of the National Institutes of Health, and will evaluate the safety and tolerability of this treatment and provide data on pharmacokinetics, anti-drug antibody levels, as well as an objective response rate assessment. The company is also working with investigators at the NCI to potentially conduct a Phase 1 study of SEL-403 in patients with pancreatic cancer, and is further exploring additional studies in other cancers.

Preclinical Work Continues in Gene Therapy: Previously presented data from the 2017 annual meetings of the American Society of Gene & Cell Therapy and the European Society of Gene and Cell Therapy have provided evidence for the potential of SVP-Rapamycin to unlock the full potential of this novel modality. The company continues to engage in preclinical work focused on its proprietary product candidate for the treatment of methylmalonic acidemia, as well as in support of its collaboration with Spark Therapeutics.
Second Quarter 2018 Financial Results:

Revenue: For the second quarter of 2018, the company recognized no revenue, which compares to less than $0.1 million for the second quarter of 2017. The decline is the result of reduced revenue recognized from the company’s grants and collaborations.

Research and Development Expenses: Research and development expenses for the second quarter of 2018 were $14.4 million, which compares to $11.0 million for the second quarter of 2017. The increase is primarily the result of higher clinical costs related to the company’s Phase 2 trial of SEL-212, preparation for the start of the SEL-212 Phase 3 program and incremental headcount-related expenses.

General and Administrative Expenses: General and administrative expenses for the second quarter of 2018 were $4.4 million, which compares with $4.9 million for the second quarter of 2017. The reduction in costs is primarily the result of reduced patent related costs and contract license fees associated with collaborations.

Net Loss: For the second quarter of 2018, Selecta reported a net loss of $(18.8) million, or $(0.84) per share, compared to a net loss of $(16.0) million, or $(0.85) per share, for the same period in 2017.

Cash Position: Selecta had $66.2 million in cash, cash equivalents, short-term deposits and investments as of June 30, 2018, which compares with a balance of $83.1 million at March 31, 2018. Selecta expects that its cash, cash equivalents, short-term deposits and investments will be sufficient to fund the company’s operating expenses and capital expenditure requirements through the end of the third quarter of 2019. The current operating plan accounts for funding in preparation for the planned Phase 3 clinical trial for SEL-212 and initial patient enrollment into a couple of Phase 3 clinical trial sites, but the company will require an additional equity offering or other external sources of capital to expand enrollment in the Phase 3 trial and to conduct the planned head-to-head trial against Krystexxa.
Conference Call Reminder
Selecta management will host a conference call at 8:30 a.m. ET today to review the company’s second quarter financial results. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, View Source Individuals may also participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10122287.

On August 8, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies that harness the power of innate and adaptive immunity (NK and T cells), reported financial and operational results for the quarter ended June 30, 2018 (Press release, Affimed, AUG 8, 2018, View Source [SID1234528541]).

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"We are continuing to progress according to plan with all of our pipeline programs. For our most advanced program, AFM13, clinical development is on track and we are in ongoing discussions with clinical and regulatory experts to define future development paths," said Dr. Adi Hoess, Affimed’s CEO. "In addition, we are deepening our understanding of the cellular and molecular mechanisms underlying our engagers’ activation of innate immune cells for tumor cell killing, which is important for advancement and expansion of our pipeline."

Second Quarter Pipeline Progress

NK cell engager programs

AFM13 (CD30/CD16A)

Affimed reported interim data from its Phase 1b combination study of AFM13 with Merck’s Keytruda (pembrolizumab) in patients with relapsed/refractory Hodgkin lymphoma (r/r HL) at the 23rd Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm in June. The combination of AFM13 and pembrolizumab was well tolerated and showed encouraging response rates versus pembrolizumab monotherapy. Affimed plans to provide updated 3- and 6-month results at a scientific or medical conference in the fourth quarter of 2018.
Recruitment has been completed into an investigator-sponsored translational Phase 1b/2a study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation led by Columbia University. Data from this study suggest AFM13 single-agent activity in this additional indication. The investigators plan to provide results from this study at a scientific or medical conference in the fourth quarter of 2018.
Based on the promising data generated to date, Affimed is currently evaluating future clinical development plans for AFM13 and intends to initiate discussions with the U.S. Food and Drug Administration on potential expedited development paths for AFM13.
AFM24 (EGFR/CD16A)

Affimed presented data from its AFM24 program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting in Chicago in April. AFM24 is designed to treat patients with a variety of EGFR expressing solid tumors with the potential for better efficacy and safety as compared to current therapeutic anti-EGFR monoclonal antibodies that are associated with significant toxicities. Affimed anticipates completing IND-enabling studies by mid-2019.
AFM26 (BCMA/CD16A)

Affimed’s AFM26 program is progressing through preclinical development towards IND-enabling studies. Affimed intends to provide an update on this program at a scientific or medical conference in the fourth quarter of 2018.
NK cell engager opportunities

Affimed is exploring the combination of AFM13 with adoptive NK cell transfer in preclinical models to enhance efficacy in a collaboration with the MD Anderson Cancer Center (MDACC). In these experiments, MDACC is investigating an allogeneic NK cell product (cord blood derived and activated NK cells). MDACC and Affimed plan to report data on the combination at a scientific or medical conference in the fourth quarter of 2018.
Affimed continues investigating the cellular and molecular mechanisms of NK cells and macrophages by which CD16A-specific immune cell engaging antibodies eliminate tumor cells and expects to provide additional data at a scientific or medical conference in the fourth quarter of 2018.
Affimed continues to evaluate additional opportunities to harness innate and adaptive immunity in rational combinations. In June, Affimed entered into a preclinical research collaboration with Nektar Therapeutics whereby the two companies intend to investigate the approach of combining Affimed’s NK cell engagers with Nektar’s cytokine-based products NKTR-214 and NKTR-255 to potentially achieve deeper clinical responses.
T cell engager programs

AFM11 (CD19/CD3)

Affimed’s two clinical Phase 1 dose escalation trials with AFM11, a CD19/CD3-targeting tetravalent bispecific T cell engager, in patients with r/r acute lymphocytic leukemia (ALL) and with r/r non-Hodgkin lymphoma (NHL), are actively recruiting patients and dose escalation is ongoing. The ALL study is currently recruiting into the sixth dose cohort, and the NHL study is currently recruiting the fifth dose cohort. Affimed plans to provide an update on AFM11 at a scientific or medical conference in the fourth quarter of 2018.
AMV564 (CD33/CD3), developed by Amphivena

Amphivena Therapeutics, Inc. reported initial data from its first-in-human Phase 1 study evaluating AMV564, a T cell engager based on Affimed’s technology platform, in r/r acute myeloid leukemia (AML) at EHA (Free EHA Whitepaper) in June. The data demonstrate that AMV564 engages and activates T cells resulting in leukemic cytoreduction. Amphivena has also initiated a Phase 1 dose escalation study of AMV564 myelodysplastic syndrome (MDS). Affimed owns approximately 18.5% of Amphivena (fully diluted) and has recently participated in a convertible bridge financing of Amphivena.
Second Quarter Corporate Updates

In June, Mathieu Simon, M.D., a seasoned immuno-oncology expert, was appointed to Affimed’s Supervisory Board. Prior to joining Affimed, Dr. Simon served as Executive Vice President and Chief Operating Officer of Cellectis (Nasdaq: CLLS), a biopharmaceutical company developing CAR-T cell immunotherapies and was a member of the company’s Board of Directors. Dr. Simon is an advisor to the European Commission’s D.G. Research and Innovation and serves as Senior Strategic Advisor to Messier Maris Partners & Associates, an M&A advisory firm based in Paris, London and New York, and serves as a board member for several EU biotech companies.
Affimed strengthened its U.S. presence with the addition of Vatnak Vat-Ho, Vice President, Business Development and Gregory Gin, Head of Investor Relations. Vatnak was previously at Pfizer Inc. (NYSE: PFE) where he most recently served as Senior Director for Strategy, Business Development & Alliances where he was responsible for implementation of new business opportunities for Pfizer Oncology. Gregory has more than 20 years of experience in investor relations with biotechnology, specialty pharmaceutical and medical device companies in multiple therapeutic areas including oncology, and most recently served as Head of Investor Relations for Edge Therapeutics, Inc. (Nasdaq: EDGE).
In June, Affimed’s subsidiary AbCheck signed a three-year agreement with MolMed S.p.A. (MLMD.MI) for the development of T and NK cell-based CARs targeting novel tumor antigens. Under the agreement, AbCheck will use its proprietary discovery platform to select, optimize and deliver multiple human single-chain variable fragments, specifically recognizing each MolMed target candidate, thus delivering high-quality human antibodies suitable for clinical development by MolMed.
In June, Affimed held its Annual General Meeting of Shareholders. All matters voted on at the meeting were approved by the company’s shareholders.

Financial Highlights

(Figures for the second quarter and six months ended June 30, 2018 and 2017 represent unaudited figures)

Cash and cash equivalents totaled €47.4 million as of June 30, 2018 compared to €39.8 million as of December 31, 2017. The increase was primarily attributable to the net proceeds of €19.7 million from the public offering in February 2018, partially offset by Affimed’s operational expenses.

Net cash used in operating activities was €15.2 million for the six months ended June 30, 2018 compared to €13.1 million for the six months ended June 30, 2017. The increase was primarily related to higher cash expenditure for research and development (R&D) in connection with Affimed’s clinical development programs.

Revenue for the second quarter of 2018 was €0.2 million compared to €0.5 million for the second quarter of 2017. Revenue in the 2018 period was solely derived from AbCheck services while revenue in the 2017 period relates to Affimed’s former collaboration with Amphivena and AbCheck services.

R&D expenses for the second quarter of 2018 were €7.1 million compared to €5.4 million for the second quarter of 2017. The increase was primarily related to higher expenses for AFM13 and AFM11.

G&A expenses for the second quarter of 2018 were slightly higher at €2.2 million compared to €2.0 million for the second quarter of 2017.

Net loss for the second quarter of 2018 was nearly unchanged at €8.0 million, or €0.13 per common share, compared to a net loss of €7.9 million, or €0.18 per common share, for the second quarter of 2017. The increase in operating expenses was offset by finance income of €1.1 million in the second quarter of 2018, whereas finance costs of €1.2 million were shown in the second quarter of 2017.

Note on IFRS Reporting Standards

Affimed prepares and reports the consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles (GAAP) in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information

Affimed’s management will host a conference call to discuss the company’s financial results and recent corporate developments today at 8:30 a.m. ET. A webcast of the conference call can be accessed in the "Events" section on the "Investors & Media" page of the Affimed website at View Source A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived on the Affimed website for 30 days following the call.

On August 8, 2018 Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), a biopharmaceutical company focused on bringing innovative medicines to people with kidney disease, reported its financial results for the second quarter ended June 30, 2018 (Press release, Keryx Biopharmaceuticals, AUG 8, 2018, View Source [SID1234528540]). The company also reviewed its commercial progress with Auryxia and provided a general business update.

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"We are very pleased with the continued strong performance of Auryxia, which is a testament to the appreciation physicians have for the product profile and to the commitment and drive of our commercial and field-based teams," said Jodie Morrison, interim chief executive officer of Keryx Biopharmaceuticals. "On June 28th, we announced that Keryx had entered a definitive merger agreement with Akebia Therapeutics that will create a fully integrated company focused on the development and commercialization of therapeutics for patients with chronic kidney disease. We believe that the combined company will be well positioned to create significant shareholder value and accelerate growth beyond what either company would achieve separately."

Business Highlights

Net U.S. Auryxia product sales were $24.1 million in the second quarter of 2018, as compared to $14.1 million in the same quarter in 2017, representing growth of 71 percent.
Approximately 42,500 Auryxia prescriptions were reported in the second quarter of 2018, representing 8.4 million Auryxia tablets. This compares to approximately 21,100 prescriptions and 4.5 million Auryxia tablets in the second quarter of 2017.
The breadth and depth of physicians prescribing Auryxia continued to expand in the second quarter of 2018 compared to the same period in 2017, with approximately 50 percent more physicians writing Auryxia prescriptions and prescribers on average writing Auryxia for more of their patients.
On June 28, 2018, Keryx announced that it had entered a definitive merger agreement with Akebia Therapeutics, Inc. that is expected to close by the end of 2018, subject to shareholder approvals and customary closing conditions. If approved, Keryx shareholders would gain access to an innovative Phase 3 product candidate with the potential to compete in a complementary multi-billion-dollar market upon successful completion of its development program. Additionally, Keryx shareholders gain a seasoned executive with decades of experience in the renal field to lead the combined organization.
Second Quarter Ended June 30, 2018 Financial Results

"Revenue growth in the second quarter of 2018, as compared to the second quarter of 2017, was driven by significant increases in Auryxia prescription and tablet demand," said Scott Holmes, senior vice president and chief financial officer of Keryx Biopharmaceuticals. "Post the close of the second quarter we established an asset-based revolving credit facility with Silicon Valley Bank for up to $40 million. We believe this non-dilutive financing instrument will provide financial flexibility to our company as we continue to increase demand for Auryxia in both indications."

Total revenues for the quarter ended June 30, 2018 were $25.7 million, compared with $15.1 million during the same period in 2017. Total revenues for the second quarter of 2018 include $24.1 million in net U.S. Auryxia product sales, as compared to $14.1 million in the second quarter of 2017. Total revenues for the second quarter of 2018 also include $1.6 million in license revenue, as compared to $1.0 million during the same period in 2017.

Cost of goods sold for the quarter ended June 30, 2018 were $7.4 million, compared with $4.4 million during the same period in 2017.

Selling, general and administrative expenses for the quarter ended June 30, 2018 were $28.7 million, as compared to $25.0 million during the same period in 2017. Selling, general and administrative expenses for the quarter ended June 30, 2018 included $4.4 million in non-cash stock compensation expense, as compared to $3.2 million during the second quarter of 2017.

Research and development expenses for the quarter ended June 30, 2018 were $8.8 million, as compared to $9.0 million during the same period in 2017. Research and development expenses for the quarter ended June 30, 2018 included $0.6 million in non-cash stock compensation expense, as compared to $0.5 million during the same period in 2017.

Net loss for the quarter ended June 30, 2018 was $21.5 million, or $0.18 per share, as compared to a net loss of $86.5 million, or $0.77 per share, for the same period in 2017. Net loss for the quarter ended June 30, 2018 included $1.3 million in non-cash interest expense related to the amortization of a discount recognized in connection with the modification of the convertible senior notes. Net loss for the quarter ended June 30, 2017 included $63.0 million in non-cash charges related to the restructuring of our convertible debt.

Cash and cash equivalents as of June 30, 2018 totaled $49.5 million.

Conference Call Information
Keryx Biopharmaceuticals will host an investor conference call today, August 8, 2018, at 8:00 a.m. ET to discuss financial results for the second quarter of 2018. To participate in the conference call, please dial (888) 584-2172, (774) 264-7578 (international) and refer to conference ID: 9756999. The call will be webcast live with slides and accessible through the Investors section of the company’s website at www.keryx.com for a period of 15 days after the call.

About Auryxia (ferric citrate) tablets
Auryxia (ferric citrate) was approved by the U.S. Food and Drug Administration (FDA) on September 5, 2014 for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis and approved by the FDA on November 6, 2017 for the treatment of iron deficiency anemia in patients with chronic kidney disease not on dialysis. Auryxia tablets were designed to contain 210 mg of ferric iron, equivalent to 1 gram of ferric citrate, and offers convenient mealtime dosing. The starting dose of Auryxia for the treatment of hyperphosphatemia for patients on dialysis is six tablets per day (two per meal) and for the treatment of iron deficiency anemia in patients not on dialysis is three tablets per day (one per meal). For more information about Auryxia and the U.S. full prescribing information, please visit www.Auryxia.com.

IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA (ferric citrate)

CONTRAINDICATION

AURYXIA (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis.

WARNINGS AND PRECAUTIONS

Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy.
Risk of Overdosage in Children Due to Accidental Ingestion: Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children.
ADVERSE REACTIONS

Most common adverse reactions with AURYXIA were:

Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%)
Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%)
SPECIFIC POPULATIONS

Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman.
To report suspected adverse reactions, contact Keryx Biopharmaceuticals at 1-844-445-3799.

Please click here to view the Full Prescribing Information for Auryxia.

On August 8, 2018 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial and operating results for the six months ended June 30, 2018 (Press release, Trillium Therapeutics, AUG 8, 2018, View Source [SID1234528539]).

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"We are continuing to build upon the observed single-agent activity of TTI-621, our lead CD47 blocking agent, in T cell lymphoma patients, and are also now dosing patients with TTI-622, our second SIRPaFc decoy receptor," said Dr. Niclas Stiernholm, president and CEO of Trillium Therapeutics. "With two unique CD47-directed therapies in clinical testing, and strong support and enthusiasm from our clinical collaborators, we continue our role as a leader in the field of CD47 research."

2018 Second Quarter Highlights:

Based on clinical observations in the TTI-621 intravenous trial, the company has refined its monotherapy efforts to focus on T cell malignancies, specifically T cell lymphomas. Combination cohorts with rituximab and nivolumab continue to enroll. Patients with cutaneous T cell lymphoma and Sezary syndrome are being enrolled in the expansion phase of the intratumoral trial, receiving continued weekly injections. In both trials, new clinical investigators and sites with experience in the treatment of T cell lymphoma are being added.
The company initiated dosing in its two-part, multicenter, open-label, phase 1a/1b clinical trial of TTI-622 (SIRPaFc-IgG4), a checkpoint inhibitor of the innate immune system, in relapsed or refractory lymphoma or myeloma. In the phase 1a dose-escalation part, patients will be enrolled in sequential dose cohorts to receive TTI-622 once weekly to characterize safety, tolerability, pharmacokinetics, and to determine the maximum tolerated dose. In the phase 1b part, patients will be treated with TTI-622 in combination with rituximab, a proteasome inhibitor-containing regimen, or a PD-1 inhibitor.
Yaping Shou MD, PhD, joined Trillium as Chief Medical Officer. Dr. Shou has more than 18 years of industry experience spanning clinical development and translational medicine, with a strong focus in oncology. She most recently served as Executive Medical Director at Takeda Pharmaceuticals, where she also held several other clinical leadership positions over the past seven years.
Trillium entered into a Second Amended and Restated License Agreement with the licensors of the SIRPaFc technology and removed the sublicense revenue sharing provisions in return for a payment to the Licensors of $3.0 million in the form of 369,621 common shares. Trillium believes the amendments to the agreement provide the company with greater financial potential and flexibility in any future partnership discussions.
Second Quarter 2018 Financial Results:

As of June 30, 2018, Trillium had cash and cash equivalents and marketable securities, and working capital of $64.7 million and $53.4 million, respectively, compared to $81.8 million and $68.9 million, respectively at December 31, 2017. The decrease in cash and cash equivalents and marketable securities was due mainly to cash used in operations of $20.0 million, net of an unrealized foreign exchange gain of $3.0 million. The decrease in working capital was due mainly to cash used in operations, an increase to prepaid expenses, and a decrease to accounts payable and accrued liabilities due to clinical trial payments.

Net loss for the six months ended June 30, 2018 of $20.9 million was lower than the loss of $23.1 million for the six months ended June 30, 2017. The net loss was lower due mainly to a net foreign currency gain of $3.0 million for the six months ended June 30, 2018, compared to a net foreign currency loss of $2.6 million in the prior year period, and lower manufacturing costs, partially offset by higher clinical trial expenses and the expense relating to the amendment of the SIRPaFc license agreement.