On August 9, 2018 Dova Pharmaceuticals, Inc. (NASDAQ: DOVA), a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for rare diseases where there is a high unmet need, reported its operating and financial results for the second quarter ended June 30, 2018 (Press release, Dova Pharmaceuticals, AUG 9, 2018, View Source [SID1234528822]).

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"In the second quarter, we achieved our most significant milestone in Dova’s corporate history with the approval and launch of DOPTELET in the United States" said Alex C. Sapir, President and Chief Executive Officer of Dova. "We are pleased with the feedback we are hearing from physicians both in terms of how the drug is performing clinically, as well as the reimbursement support their patients are receiving through DOVA1SOURCE. This has translated to a high level of payer approval, as over 80% of referrals have been approved. In addition, we remain well-positioned financially, with approximately $135M in cash and equivalents to fund the operational success of the company for the foreseeable future."

DOPTLET Launch Highlights

·On May 21st, DOPTELET was approved by the U.S. Food and Drug Administration (FDA) for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. DOPTELET was launched in the United States on June 4th.

·A total of 148 health care professionals have prescribed DOPTELET to their patients since launch with an increasing number using DOPTELET for multiple patients within their practice.

· For prescriptions that have completed the adjudication process with payers, the Company has seen greater than 80% of those prescriptions approved by the payer with an average approval time of 6.9 days.

·The Company has made significant progress in its outreach efforts to target prescribers having reached 62% of top hepatologists an average of 3.1 times since launch.

· Pivotal Phase 3 data for DOPTELET were published in Gastroenterology (View Source). The data were also highlighted at several key global scientific conferences including Digestive Disease Week (DDW) 2018, the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), and the 64th International Society on Thrombosis and Haemostasis (ISTH).

Other Important Highlights for the Quarter

·On April 27th, the Company submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for DOPTELET for the treatment of thrombocytopenia in adult patients with CLD who are scheduled to undergo a procedure. The EMA has granted a Standard Review Assessment with a targeted decision date of July 2019.

· A supplemental New Drug Application (sNDA) for the treatment of patients with chronic immune thrombocytopenia (ITP) who have had an inadequate response to a previous treatment remains on track for submission to the FDA in the third quarter of 2018.

· The Company has initiated a Phase 3 clinical trial for the treatment of patients with chemotherapy-induced thrombocytopenia (CIT).

· The Company repaid, in full, the secured promissory note that was issued to Eisai on March 31, 2016 of $31.1 million. The Company refinanced a portion of the note by entering into a Loan and Security Agreement with Silicon Valley Bank (SVB) for $20.0 million on April 17, 2018. The loan matures on April 17, 2021 unless a specified revenue milestone is achieved in which case the maturity date will be extended to April 17, 2022.

·Nancy J. Wysenski, an industry veteran with over 30 years of commercial and sales leadership, joined the Company’s Board of Directors. As the former Chief Commercial Officer at Vertex, she was responsible for launching Incivek, a treatment for hepatitis C, which is considered by many to be the most successful drug launch in U.S. history.

Dova will provide an update and additional details on DOPTELET’s launch activities during today’s call as well as at its upcoming Investor and Analyst Day scheduled for September 20, 2018 in New York City, New York. To RSVP for this event, please email John Woolford at [email protected].

Second Quarter and Financial Results

Dova reported a net loss of $20.0 million for the second quarter of 2018, compared to a net loss of $5.5 million for the same period in 2017.

For the second quarter of 2018, Dova reported net product sales from DOPTELET of $2.0 million. The Company recognizes revenue using the sell-in methodology when products are delivered to its specialty pharmacy partners. The majority of net sales recognized in the quarter were related to the initial stocking of DOPTELET at the specialty pharmacies. In addition, in March 2018, Dova entered into an exclusive distribution agreement with Shanghai Fosun Pharmaceutical Industrial

Development Co., Ltd., (Fosun Pharma Industrial). Dova received a $5.0 million upfront payment from Fosun Pharma Industrial of which $2.6 million was recognized as revenue during the second quarter of 2018. There were no product sales or other revenue in the second quarter of 2017.

Cost of product sales for the second quarter were $0.5 million, of which approximately $0.3 million consisted of a one-time stock-based compensation charge.

Research and development expenses were $4.5 million in the second quarter of 2018, compared to $3.3 million for the same period in 2017. The increase was primarily due to the initiation of Phase 3 clinical trials to evaluate DOPTELET for patients with thrombocytopenia undergoing surgery regardless of disease etiology and chemotherapy-induced thrombocytopenia.

Selling, general and administrative expenses were $18.6 million in the second quarter of 2018, compared to $1.9 million for the same period in 2017. The increase was primarily due to building Dova’s commercial infrastructure to support the launch of DOPTELET, increased corporate infrastructure, and additional costs associated with operating as a public company.

As of June 30, 2018, Dova had $134.7 million in cash and equivalents compared to $94.8 million as of December 31, 2017.

Company to Host Conference Call

Dova will host a conference call today, August 9, 2018 at 4:30 p.m. ET to discuss second quarter 2018 financial results and recent operational highlights. A question-and-answer session will follow Dova’s remarks.

To participate on the live call, please dial 866-550-8145 (domestic) or +1-430-775-1344 (international) and provide the conference ID 9093837 five to 10 minutes before the start of the call.

A live audio webcast of the call will also be available via the "Investor Relations" page of the Dova website, www.dova.com. Please log on through Dova’s website approximately 10 minutes before the scheduled start time. A replay of the webcast will be archived on Dova’s website for 90 days following the call.

Indication and Important Safety Information

INDICATION

DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists. In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-emergent event of portal vein thrombosis in a patient (n=1/430) with chronic liver disease and thrombocytopenia treated with DOPTELET.

Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).

DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.

CONTRAINDICATIONS:

None

ADVERSE REACTIONS

Most common adverse reactions (> 3%) were: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.

Please see full Prescribing Information for DOPTELET (avatrombopag) www.doptelet.com

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 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported a business update and financial results for the second quarter ended June 30, 2018 (Press release, Leap Therapeutics, AUG 8, 2018, View Source [SID1234528560]).

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"Over the past few months, we have seen patients in the studies of both of our antibody programs experience clinical responses in combination with checkpoint inhibitors, including in patients who would not be expected to respond to checkpoint inhibitors alone. We look forward to continuing to read out data throughout the second half of 2018 from these ongoing clinical trials, including from our study evaluating DKN-01 in combination with KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer at the European Society for Molecular Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting in October," commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. "In addition, we recently announced a TRX518 collaboration with Pfizer and EMD Serono to add to our existing DKN-01 collaborations with Merck and Roche."

Recent Highlights

Since the end of the first quarter, we have made substantial progress with the development of our product candidates:

· Presented clinical results from our study evaluating DKN-01 in combination with KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer.

· Combination has been well tolerated with no dose limiting toxicity.

· In the high-dose DKN-01 cohort of dose escalation, two of four evaluable patients naïve to anti-PD-1/PD-L1 therapy have had a partial response, with two other evaluable patients having a best response of stable disease.

· Both of the responding patients have a tumor phenotype which is typically less responsive to anti-PD-1 therapy.

· Currently enrolling expansion cohorts in patients who are naïve to anti-PD-1/PD-L1 therapy and patients who are refractory to anti-PD-1/PD-L1 therapy.

· The treatment-naïve cohort has passed the Simon Stage 2 threshold.

· Enrollment of the full study is expected during the first quarter of 2019.

· Additional data from this study will be presented at the ESMO (Free ESMO Whitepaper) 2018 Annual Meeting in October.

· Announced a collaboration agreement with Pfizer and Merck KGaA, Darmstadt, Germany to evaluate TRX518 in combination with BAVENCIO (avelumab) and cyclophosphamide chemotherapy.

· Under the terms of the collaboration, we will be conducting a Phase I/II clinical trial in advanced solid tumors including expansion populations in patients with relapsed/refractory ovarian, breast, and prostate cancers.

· The study is expected to begin enrolling patients in the first quarter of 2019.

· Presented initial data from our clinical trial evaluating TRX518 in combination with gemcitabine chemotherapy or in combination with KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab).

· The first two patients treated with the higher dose of TRX518 in combination with KEYTRUDA have experienced clinical benefit after the end of two cycles of therapy.

· Esophageal squamous cell carcinoma patient demonstrated a partial response with a 36% reduction in tumor volume.

· Ocular melanoma patient experienced stable disease with a 23% reduction in tumor volume.

· Seven patients have been treated with the lower dose of TRX518 in combination with OPDIVO.

· Urothelial carcinoma patient who had progressed while on KEYTRUDA has had a partial response with a 39% reduction in tumor volume after the end of two cycles.

· Four other patients experienced progressive disease, one patient was non-evaluable, and one patient has not yet had any on treatment disease evaluation.

·Enrollment continues in the dose escalation phase for both the KEYTRUDA and OPDIVO combinations and in the dose expansion phase for the gemcitabine combination.

Selected Second Quarter 2018 Financial Results

Net loss was $7.4 million for the second quarter of 2018, compared to $6.9 million for the same period in 2017.

Research and development expenses were $4.2 million for the second quarter 2018, compared to $4.9 million for same period in 2017. The decrease of $0.7 million was primarily due to a decrease of $0.4 million in manufacturing costs related to clinical trial material, a decrease of $0.2 million in clinical trial costs and a decrease of $0.2 million in consulting fees associated with research and development activities. These decreases were partially offset by an increase of $0.1 million in stock based compensation expense.

General and administrative expenses were $2.6 million for the second quarter 2018, compared to $2.1 million for the same period in 2017. The increase of $0.5 million in general and administrative expenses was primarily due to a $0.4 million increase in legal, audit and consulting fees associated with corporate and business development activities and an increase of $0.1 million of stock based compensation expense.

Cash, cash equivalents and marketable securities totaled $30.5 million at June 30, 2018. Research and development incentive receivables totaled $1.8 million. The Company believes that its current cash and cash equivalents and the anticipated receipt of the research and development incentive receivable will be sufficient to fund the Company’s operating expenses into the fourth quarter of 2019.

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 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported its financial results for the second quarter ended June 30, 2018 and provided an update on its programs (Press release, Synlogic, AUG 8, 2018, View Source [SID1234528561]).

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"Synlogic’s recent progress, including initiation of two clinical trials and multiple presentations of preclinical data, highlight the potential of Synthetic Biotic medicines across a range of diseases," said Aoife Brennan, M.B., B.Ch., Synlogic’s interim president and chief executive officer and chief medical officer. "In the second half of 2018, we look to continue this momentum as we advance our clinical pipeline, with data expected from phase 1/2 clinical trials of our two lead programs, SYNB1020 in patients with hyperammonemia due to cirrhosis and SYNB1618 in healthy volunteers. In addition, we look forward to advancing our first immuno-oncology program into IND-enabling studies for the treatment of cancer."

Recent Highlights
Pipeline

Presentation of preclinical data highlighting potential of Synthetic Biotic medicines in immuno-oncology (IO) at the annual meeting of the Federation of Clinical Immunology Societies (FOCIS 2018), including the platform’s broad capabilities to generate candidates that secrete or consume immunologically relevant compounds for the potential treatment of cancer and inflammation. Data presented in two sessions demonstrate that intratumorally injected E. coli Nissle was able to colonize and persist in the tumor, and that multiple functions can be engineered into a single bacterial strain. These properties support the continued development of Synthetic Biotic immunotherapies for the treatment of solid tumors, particularly "cold" tumors that may be resistant to current immunotherapies due to their lack of infiltrating immune cells or a highly immunosuppressive tumor microenvironment. Synlogic plans to advance its first immuno-oncology program into IND-enabling studies in the fourth quarter of 2018.
Presentation of preclinical data supporting continued development of SYNB1618 for the treatment of Phenylketonuria (PKU) in a plenary session at the annual meeting of the American Society for Microbiology (ASM Microbe 2018). The data demonstrate, in a mouse model of PKU and healthy non-human primates, that orally administered SYNB1618 can result in significant decreases in blood phenylalanine levels and dose-responsive pharmacokinetics. Synlogic is currently evaluating SYNB1618 in a Phase 1/2a clinical trial for the management of PKU and expects to report interim data from healthy volunteers before the end of 2018 and full data that includes cohorts of patients with PKU in 2019.
Presentation of new preclinical data highlighting beneficial activity of SYNB1020 in animal model of liver disease at Digestive Disease Week (DDW 2018). The data demonstrate that, in addition to lowering systemic levels of ammonia, administration of SYNB1020 resulted in reduced indicators of liver damage, providing additional support for its continued development for the potential treatment of liver disease. SYNB1020 is currently being evaluated in a Phase 1b/2a clinical trial in patients with elevated ammonia due to cirrhosis, with topline data expected at the end of 2018.
Corporate

Strengthened balance sheet: As of June 30, 2018, Synlogic had cash, cash equivalents, and short-term investments of $143.2 million which includes $28.9 million in net proceeds generated by a registered direct offering completed in April 2018.
Addition to Russell 3000 Index following its annual reconstitution, providing Synlogic increased visibility and exposure to institutional investors.
Second Quarter 2018 Financial Results
For the three months ended June 30, 2018, Synlogic reported a consolidated net loss of $14.6 million, or $0.59 per share, compared to a consolidated net loss of $9.4 million, or $4.70 per share, for the corresponding period in 2017.

Research and development expenses were $10.9 million for the three months ended June 30, 2018 compared to $8.5 million for the corresponding period in 2017. The increase was primarily due to an increase in expenses associated with Synlogic’s SYNB1618 program including its ongoing Phase 1/2a clinical trial, an increase in compensation and other employee-related expenses associated with increased headcount, partially offset by one-time equity-based and patent-related charges of $2.1 million associated with Synlogic’s MIT-BU license agreement.

General and administrative expenses for the three months ended June 30, 2018 were $4.7 million compared to $3.0 million for the corresponding period in 2017. The increase was primarily due to an increase of $1.2 million in compensation costs associated with the separation of Synlogic’s former chief executive officer, as well as compensation and other employee-related expenses associated with increased headcount.

Revenues were $0.3 million for the three months ended June 30, 2018, compared to $2.1 million for the corresponding period in 2017. Revenue for both periods was associated with Synlogic’s collaboration with AbbVie to develop Synthetic Biotic medicines for the treatment of irritable bowel disease (IBD). The decrease in revenue was primarily the result of a milestone achieved and recognized during the three months ended June 30, 2017.

Six-months Results
For the six months ended June 30, 2018, the consolidated net loss was $25.8 million, or $1.14 per share, compared to a consolidated net loss of $16.8 million, or $9.20 per share, for the corresponding period in 2017.

Total operating expenses were $27.6 million for the six months ended June 30, 2018, compared to $19.1 million for the corresponding period in 2017. The increase in operating expenses was primarily due to compensation-related expenses associated with increased headcount, increased external costs associated with development of Synlogic’s Synthetic Biotic programs including process and formulation development, pre-clinical and clinical studies as well as increased general and administrative expenses as a consequence of becoming a public company.