On August 8, 2018 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) reported its financial results for the second quarter and the first six months 2018 ending June 30 (Press release, Epigenomics, AUG 8, 2018, View Source [SID1234528654]).

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!

"While we continue to pursue our objective of Medicare coverage for Epi proColon in the U.S., we are moving forward with our innovative liver cancer surveillance test", said Greg Hamilton, CEO of Epigenomics AG. "Based on the recently published excellent clinical data, this new blood-test could provide the next major opportunity for our company. Obtaining CE mark by year-end will be a key milestone for the product."

Q2/6M 2018 Financial Results

-Total Q2 2018 revenue increased to EUR 0.5 million (Q2 2017: EUR 0.2 million) and 6M 2018 revenue grew to EUR 0.8 million (6M 2017: EUR 0.5 million) due to higher revenue in the United States and license payments made by our partner in China.

-Product revenue in Q2 2018 increased by 65% to EUR 0.3 million (Q2 2017: EUR 0.2 million). In the six month period 2018, product revenue increased by 56% to EUR 0.4 million (6M 2017: EUR 0.2 million).

-Adjusted for non-cash expenses related to share-based payment expenses, EBITDA in Q2 2018 was at EUR -2.2 million (Q2 2017: EUR -3.4 million); adjusted EBITDA for 6M 2018 amounted to EUR -5.4 million (6M 2017: EUR -5.8 million). The lower EBITDA loss is mainly due to increased revenue and lower SG&A expenses.

-Net loss amounted to EUR 2.6 million in Q2 2018 compared to EUR 4.1 million in Q2 2017, and EUR 5.8 million for 6M 2018 (6M 2017: EUR 6.5 million). Net loss per share for Q2 2018 decreased to EUR 0.11 (Q2 2017: EUR 0.18) and for 6M 2018 to EUR 0.24 (6M 2017: EUR 0.28).

-Cash consumption (cash outflow from operating and investing activities) was EUR 4.2 million in 6M 2018 compared to EUR 4.7 million in 6M 2017.

-Liquid assets (including marketable securities) amounted to EUR 9.4 million at the reporting date (December 31, 2017: EUR 7million).

Operational highlights

-Centers for Medicare & Medicaid Services published preliminary rate for Epigenomics’ colorectal cancer screening test Epi proColon: The Centers for Medicare & Medicaid Services (CMS) published a preliminary reimbursement rate of $192 per Epi proColon test. Based on the proposed preliminary rate, CMS will determine the final rate. The publication of the final rate is expected in November 2018.

-Blood test shows promise in the detection of liver cancer: Results from two clinical studies published in EBioMedicine supported by Cell Press and The Lancet, demonstrated high accuracy of Epigenomics’ proprietary epigenetic circulating biomarker mSEPT9 in detecting liver cancer among patients with cirrhosis. In the studies, the mSEPT9 test exhibited higher diagnostic accuracy than the currently established diagnostic marker. A further independent, prospective clinical study with 440 patients was initiated.

-Liquid biopsy test for liver cancer detection to obtain CE mark: Epigenomics announced it’s plan to CE mark the mSEPT9 blood test by year-end 2018 as an aid in detecting liver cancer among patients with cirrhosis. In 2019, the Company also plans to initiate a prospective clinical trial in the U.S. for submission to the FDA. Additionally, Epigenomics is evaluating options to expedite CFDA approval in China. Epigenomics estimates the liver cirrhosis surveillance market to be in excess of 10 million tests per year making it more than a three billion Euro market opportunity globally.

Outlook 2018 confirmed

-The Company confirms the outlook for the financial year 2018 as provided in its Annual Report 2017.

-Overall, we expect that revenue will increase but will remain on low levels, ranging between EUR 2.0 million and EUR 4.0 million.

-We anticipate that EBITDA before share-based payment expenses will be in a range EUR -11.5 million and EUR -14.0 million in 2018.

Further Information

The interim report for the first six months 2018 can be downloaded from Epigenomics’ website at: View Source

Conference call for analysts and investors

The Company will host a conference call and webcast at 2.30 pm CET / 8.30 am EDT, today. The presentation can be followed on the Company’s website.

The dial-in numbers for the conference call are:

Germany: +49 30 232531428
UK: +44 1635 598060
USA: +1 516-269-8983

The webcast will be made available on: View Source;lang=en

An audio replay of the conference call will be provided on Epigenomics’ website subsequently.

On August 8, 2018 Nordic Nanovector ASA (OSE: NANO) reported its second quarter and first half 2018 results on Wednesday, 22 August 2018 (Press release, Nordic Nanovector, AUG 8, 2018, View Source [SID1234553496]).

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!

Second Quarter and First Half 2018 Results Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team in English will take place at 8:30 am CEST on 22 August at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: AKER

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentations/Interim Reports/2018 from 7:00 am CEST the same day.

Results presentation in Norwegian

A separate presentation of the results in Norwegian, to be hosted by Nordic Nanovector’s CFO, and its VP IR & Corporate Communications, will take place on Thursday, 23 August 2018 at 8:30 am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: VIPPETANGEN

To attend this meeting please email – [email protected]

The presentation will NOT be recorded as a webcast

On August 8, 2018 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported financial results for the fiscal quarter ended June 30, 2018 (Press release, Five Prime Therapeutics, AUG 8, 2018, View Source [SID1234528545]).

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 with the progress across our pipeline, including BMS’s ongoing randomized Phase 2 clinical trial to evaluate cabiralizumab and OPDIVO with and without chemotherapy as a second-line treatment in patients with advanced pancreatic cancer," said Aron Knickerbocker, chief executive officer of Five Prime Therapeutics. "We’ve also advanced bemarituzumab through the Phase 1 safety lead-in portion of the global FIGHT trial in gastric cancer and are on track to begin the Phase 3 portion of the trial before the end of the year. Additionally, we are pleased that the first clinical candidate from our immuno-oncology research collaboration with BMS, the TIM-3 antibody BMS-986258, is now in a Phase 1/2 trial investigating it as a single agent and in combination with OPDIVO. FPA150, our first-in-class B7-H4 antibody, is receiving strong interest from investigators and is progressing well in the Phase 1 trial."

Mr. Knickerbocker continued, "We are committed to making prudent clinical development decisions. Although we continue to observe efficacy in the PVNS Phase 2 trial, we have decided not to advance cabiralizumab into a pivotal trial in PVNS in 2019 because patients with this chronic, non-malignant disease demonstrate a lower tolerance for side effects, such as periorbital edema, relative to patients with cancer."

Second Quarter 2018 Business Highlights and Recent Developments

Clinical Pipeline:

Cabiralizumab (FPA008): An antibody that inhibits CSF1R and has been shown to block the activation and survival of macrophages.

Bristol-Myers Squibb Company (BMS) continues to advance a randomized Phase 2 clinical trial in patients with locally advanced or metastatic pancreatic cancer.
The Phase 2 clinical trial (NCT03336216) evaluates cabiralizumab and OPDIVO (nivolumab) with and without mFOLFOX6 or gemcitabine/Abraxane chemotherapy compared to chemotherapy alone as a second-line treatment in patients with advanced pancreatic cancer. The Phase 2 trial is expected to enroll approximately 160 patients from the United States, Europe, Japan and Taiwan.
Enrollment has closed and treatment continues in Five Prime’s Phase 1a/1b clinical trial of cabiralizumab and OPDIVO (nivolumab).
Five Prime and BMS are evaluating the safety, tolerability and preliminary efficacy of the immunotherapy combination of cabiralizumab with the PD-1 immune checkpoint inhibitor OPDIVO in advanced solid tumors, including in more than 70 patients with pancreatic cancer.
A poster titled "Pharmacodynamics (PD) and Genomic Profiling of Pts Treated with cabiralizumab (cabira) + nivolumab (NIVO) Provide Evidence of On-Target Tumor Immune Modulations and Support Future Clinical Applications" was presented and chosen for oral discussion at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 4.
Data suggest cabiralizumab in combination with nivolumab decreases immunosuppressive macrophages and increases CD8+ effector T-cells in the tumor microenvironment.
These data, together with preliminary clinical response data observed in patients with low tumor mutational burden, support further clinical development of cabiralizumab plus nivolumab in multiple indications, including pancreatic cancer.
Five Prime has decided not to advance cabiralizumab in pigmented villonodular synovitis (PVNS), a rare, locally aggressive, non-malignant tumor of the synovium, into a pivotal trial under the current dosing schedule.
Five Prime has been enrolling a second cohort in the Phase 2 portion of a Phase 1/2 clinical trial (NCT02471716) to evaluate dosing every 4-6 weeks instead of every 2 weeks to optimize the therapeutic index of cabiralizumab in PVNS.
Although Five Prime continues to observe efficacy in this second cohort, the frequency of dose interruptions and discontinuations suggests that the current dosing schedule is unlikely to be optimal for a pivotal trial in this chronic, non-fatal disease.
The company is considering alternative dosing schedules as there continues to be a high unmet need for patients with PVNS.
Apexigen, Inc. and Yale Cancer Center announced a clinical trial collaboration to evaluate APX005M (anti-CD40) in combination with cabiralizumab and OPDIVO. The phase 1/1b study (NCT03502330) is designed to identify a safe dose of APX005M to be added to cabiralizumab and OPDIVO. The expansion portion of the trial will study the triple drug combination in patients with melanoma, non-small cell lung cancer (NSCLC) or renal cell carcinoma (RCC) whose disease has progressed on a prior regimen containing a PD-1 or PD-L1 inhibitor without intervening therapy.
Bemarituzumab (FPA144): A first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immuno-therapy for tumors that overexpress FGFR2b.

Five Prime advanced through the Phase 1 safety lead-in portion (NCT03343301) of the Phase 1/3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) global registrational trial.
The company expects to initiate patient dosing in the randomized, controlled Phase 3 portion of the trial before the end of the year in the U.S., Europe and Asia, including China and South Korea, where the incidence of gastric cancer is high.
The trial will evaluate bemarituzumab in combination with the modified FOLFOX6 standard-of-care chemotherapy regimen (mFOLFOX6) versus placebo plus mFOLFOX6 in approximately 550 patients with advanced gastric or gastroesophageal junction cancer whose tumors overexpress FGFR2b.
Five Prime is using immunohistochemistry (IHC) and circulating tumor DNA (ctDNA) tests to identify the estimated 10% of patients with FGFR2b-overexpressing gastric cancer who would be eligible for the trial.
A poster titled "FIGHT: A Phase 3 Randomized, Double-Blind, Placebo Controlled Study Evaluating (Bemarituzumab) FPA144 and Modified FOLFOX6 (mFOLFOX6) in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer with a Dose Finding Phase 1 Lead-In" was presented at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting on June 3.
FPA150 (anti-B7-H4): A first-in-class antibody targeting B7-H4 designed to have two mechanisms of action: to block an inhibitory T-cell checkpoint pathway and to enhance killing of B7-H4 overexpressing tumors by ADCC. B7-H4 is frequently overexpressed in breast, ovarian, endometrial and bladder cancers.

Five Prime continues to dose patients with FPA150 monotherapy in solid tumors in the dose escalation phase of the Phase 1a/1b clinical trial.
Dose escalation will be followed by expansion in pre-specified cohorts of patients whose tumors have high B7-H4 expression levels, as measured by an IHC molecular diagnostic test. The initial targeted tumors for the expansion cohorts are breast, ovarian, endometrial and bladder cancers.
During the dose escalation, Five Prime will also open an exploratory cohort to investigate FPA150 monotherapy in patients with tumors that overexpress B7-H4.
BMS-986258 (anti-TIM-3): A fully-human monoclonal antibody targeting TIM-3 (T-cell immunoglobulin and mucin domain-3), an immune checkpoint receptor that is known to limit the duration and magnitude of T-cell responses.

In January 2018, BMS began a Phase 1/2 trial (NCT03446040), of BMS-986258, which is testing the antibody both as a single-agent and in combination with OPDIVO.
BMS-986258 is the first clinical candidate from BMS’s immuno-oncology research collaboration with Five Prime.
Preclinical Research and Development:

FPT155 (CD80-Fc): A first-in-class CD80 fusion protein that uses the binding interactions of soluble CD80 to (i) directly engage CD28 to further enhance its co-stimulatory T-cell activation activity without inducing super agonism, and (ii) block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T-cell activation in the tumor microenvironment.

Studies in preclinical models suggest FPT155 has the potential to be a potent T-cell co-stimulator with strong monotherapy antitumor activity and may have a synergistic effect when combined with anti-PD1 therapy.
Five Prime anticipates initiating a Phase 1 clinical trial of FPT155 in Australia in the fourth quarter of 2018.
Summary of Financial Results and Guidance:

Cash Position. Cash, cash equivalents and marketable securities totaled $352.8 million as of June 30, 2018, compared to $292.7 million as of December 31, 2017. The increase in cash, cash equivalents and marketable securities was primarily attributable to $107.6 million in net proceeds from the January 2018 public offering of common stock and $34.5 million in milestone and upfront payments Five Prime received from collaboration partners net of cash used by Five Prime in operations to advance its three clinical stage programs as well as preclinical research and development.
Revenue. Collaboration and license revenue for the second quarter of 2018 decreased by $0.2 million, or 3%, to $7.6 million from $7.8 million for the second quarter of 2017. This decrease was primarily due to decreased revenue recognized under the cabiralizumab collaboration agreement with BMS and the Fibrosis and CNS collaboration with UCB, offset by the collaboration and license revenue from our China collaboration with Zai Lab executed in December 2017.
R&D Expenses. Research and development expenses for the second quarter of 2018 decreased by $8.3 million, or 20%, to $33.4 million from $41.7 million in the second quarter of 2017. This decrease was primarily related to decreased spending on preclinical programs offset by an increase in clinical expenses to advance our development programs.
G&A Expenses. General and administrative expenses for the second quarter of 2018 increased by $0.4 million, or 4%, to $9.8 million from $9.4 million in the second quarter of 2017. This is primarily due to increased consulting and facility costs offset by reduced personnel costs, including stock-based compensation.
Net Loss. Net loss for the second quarter of 2018 was $34.1 million, or $0.99 per basic and diluted share, compared to a net loss of $44.3 million, or $1.58 per basic and diluted share, for the second quarter of 2017.
Shares Outstanding. Total shares outstanding were 34.5 million as of June 30, 2018.
Cash Guidance. Five Prime expects full-year 2018 net cash used in operating activities to be less than $135 million, which includes the previously mentioned milestone payments earned by Five Prime. Five Prime estimates ending 2018 with approximately $250 million in cash, cash equivalents and marketable securities.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 4194786. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

On August 8, 2018 Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) ("Foamix" or the "Company"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, reported its financial results for the second quarter and six months ended June 30, 2018 (Press release, Foamix, AUG 8, 2018, View Source [SID1234528609]).

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!

Clinical and Corporate Update:

The final patient was enrolled and dosed in the third Phase 3 study (FX2017-22) investigating FMX101, the Company’s minocycline foam 4%, in patients with moderate-to-severe acne.
Top-line results are expected in the third quarter of 2018.
The final patient has been enrolled and dosed in two Phase 3 clinical studies (FX2016-11 and FX2016-12) evaluating the safety and efficacy of FMX103, topical minocycline foam 1.5%, for the treatment of papulopustular rosacea.
Top-line results are expected early in the fourth quarter of 2018.
In April 2018, the Company raised net proceeds of approximately $16.1 million, through a direct registered offering of approximately 2.9 million shares at a price of $5.50 per share to OrbiMed Partners Master Fund Limited.
Cash & Investments
At June 30, 2018, the Company had $56.4 million in cash and investments compared to $76.4 million at December 31, 2017. During the second quarter, the Company raised net proceeds of $16.1 million, after deducting offering expenses, in a registered share offering with OrbiMed Partners Master Fund Limited. The Company believes that its existing cash and investments will be sufficient to fund operating expenses and capital expenditure requirements for the third Phase 3 clinical trial for FMX101 and NDA filing for FMX101, and for the two Phase 3 clinical trials for FMX103, which it expects to complete in 2019.

Financial Results for the Second Quarter Ended June 30, 2018
Revenues
Revenues for the second quarter of 2018 were $964,000 an increase of $166,000, or 20.8%, from $798,000 in the second quarter of 2017. The increase is due to an increase in royalty payments from Bayer for sales of Finacea Foam (azelaic acid 15%).

Operating Expenses
Research and Development Expenses
Research and development expenses for the second quarter were $16.8 million, a $2.9 million, or 20.9%, increase from $13.9 million in the second quarter of 2017. The increase in R&D expenses resulted primarily from an increase of $3.0 million in costs relating predominantly to FMX101 and FMX103 clinical trials, and an increase of $688,000 in payroll and payroll-related expenses including share-based compensation primarily due to an increase in headcount and salary raises, off-set by a decrease of $1.0 million in compensation to one of the Company’s co-founders in the second quarter of 2017.

Selling, General and Administrative Expenses
Selling, general and administrative expenses for the second quarter of 2018 were $2.9 million, a decrease of $542,000, or 15.5%, compared to $3.5 million in the second quarter of 2017. The decrease in selling, general and administrative expenses resulted primarily from a decrease of $1.2 million in compensation to one of the Company’s co-founders in the second quarter of 2017, off-set by an increase of $280,000 in payroll and other payroll-related expenses including share-based compensation mostly due to an increase in headcount and salary raises, an increase of $360,000 in advisory and professional fees and an increase of $150,000 in rent, maintenance and office expenses.

Net Loss
For the quarter ended June 30, 2018, the Company recorded a net loss of $18.6 million, or ($0.46) per share, basic and diluted, compared with a loss of $16.4 million or ($0.44) per share, basic and diluted, for the three months ended June 30, 2017.

Financial Results for the First Half Ended June 30, 2018
Revenues
Revenues for the six months ended June 30, 2018 were $1.9 million, an increase of $145,000, or 8.4%, from $1.7 million in the first six months of 2017. The increase is due to an increase in royalty payments from Bayer for sales of Finacea Foam.

Operating Expenses
Research and Development Expenses
Research and development expenses for the six months ended June 30, 2018 were $39.7 million, a $13.1 million, or 49.2%, increase from $26.6 million in the first six months of 2017. The increase in research and development expenses resulted primarily from an increase of $12.2 million in costs relating predominantly to FMX101 and FMX103 clinical trials and an increase of $1.5 million in payroll and payroll-related expenses including share-based compensation primarily due to a change in the measurement of share-based compensation expenses of a consultant and an increase in headcount and salary raises, off-set by a decrease of $1.2 million in compensation to one of the Company’s co-founders in the first half of 2017 and an increase of $383,000 in travel-related expenses.

Selling, General and Administrative Expenses
Selling, general and administrative expenses for the six months ended June 30, 2018 were $6.7 million, an increase of $437,000, or 6.9%, compared to $6.3 million in the same six month period of 2017. The increase in selling, general and administrative expenses resulted primarily from an increase of $1.5 million in payroll and payroll-related expenses including share-based compensation, mostly due to an increase in headcount, salary raises and accounting modification relating to share-based compensation expenses of a consultant, off-set by a decrease of $1.5 million in compensation to one of the Company’s co-founders in the first half of 2017; an increase of $526,000 in advisory and professional services expenses, off-set by a decrease of $112,000 in travel-related expenses.

Net Loss
For the six months ended June 30, 2018, the Company recorded a net loss of $44.6 million, or ($1.15) per share, basic and diluted, compared with a loss of $30.8 million, or ($0.82) per share, basic and diluted, for the six month ended June 30, 2017.

On August 8, 2018 Unum Therapeutics Inc. (NASDAQ:UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies based on its novel, universal Antibody-Coupled T cell Receptor (ACTR) technology platform, reported that management will present at two upcoming investor conferences (Press release, Unum Therapeutics, AUG 8, 2018, View Source [SID1234528768]):

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!

2018 Wedbush PacGrow Healthcare Conference on Wednesday, August 15, 2018 at 10:20 a.m. ET in New York, NY
Wells Fargo Securities 2018 Healthcare Conference on Thursday, September 6, 2018 at 10:55 a.m. ET in Boston, MA
Both presentations will be webcast live, and available for replay on the "Events" section of Unum’s investor relations webpage (investors.unumrx.com/events).