On August 1, 2018 VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that it will host a conference call and live audio webcast on Thursday, August 16 at 8:30am Eastern Time to report second quarter ended June 30, 2018 financial results (Press release, VBL Therapeutics, AUG 1, 2018, View Source [SID1234528290]).

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Thursday, August 16th @ 8:30am Eastern Time
US Domestic: 877-222-6394
International: 703-925-2702
Conference ID: 3572709
Webcast: View Source

Replays, Available through August 30, 2018
US Domestic: 855-859-2056
International: 404-537-3406
Conference ID: 3572709

On August 1, 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 that it plans to issue its second quarter 2018 financial results before the open of the U.S. financial markets on Wednesday, August 08, 2018 (Press release, Selecta Biosciences, AUG 1, 2018, View Source [SID1234528289]).

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At 8.30 a.m. ET that day, Selecta Biosciences will host a conference call via live webcast to discuss these 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 1, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that it will host a second quarter 2018 investor call on Thursday, August 9, 2018 at 8:00 AM (EDT) to discuss financial results and provide a corporate update (Press release, Pieris Pharmaceuticals, AUG 1, 2018, View Source [SID1234528288]).

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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

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To access the call, participants may dial 877-407-8920 (US & Canada) or 412-902-1010 (International) at least 10 minutes prior to the start of the call.

An archived replay of the call will be available for 30 days by dialing 877-660-6853 (Toll Free US & Canada) or 201-612-7415 (International) and providing the Conference ID #13661472.

On August 1, 2018 Ophthotech Corporation (Nasdaq:OPHT) reported financial and operating results for the second quarter ended June 30, 2018 and provided a business update (Press release, Ophthotech, AUG 1, 2018, View Source [SID1234528287]).

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"During the first half of the year, we continued implementing our strategy to broaden and advance our ophthalmic portfolio as we enter the emerging field of gene therapy by securing collaborations with three leading academic institutions, and continued advancing our therapeutic portfolio with Zimura," stated Glenn P. Sblendorio, Chief Executive Officer and President of Ophthotech. "Looking ahead to the remainder of 2018, we expect to report data for our Phase 2a clinical trial for Zimura combination therapy with anti-VEGF in wet-age related macular degeneration (AMD), complete recruitment for our Phase 2b clinical trial for Zimura monotherapy in geographic atrophy secondary to dry AMD and potentially enter into new opportunities to further expand our portfolio in both therapeutics and gene therapies for retinal diseases."

First Half 2018: Key Highlights

Zimura Complement Factor C5 Inhibitor Program

In April 2018, the Company completed patient recruitment in its randomized, dose-ranging, open-label, uncontrolled, multi-center Phase 2a clinical trial of Zimura (avacincaptad pegol) in combination with the anti-vascular endothelial growth factor (anti-VEGF) agent Lucentis (ranibizumab) in patients with wet age-related macular degeneration (AMD) who have not been previously treated with anti-VEGF therapies. This trial is designed to assess the safety of Zimura combination therapy at different dosages and to detect a potential efficacy signal. Data will be evaluated at month six and initial top-line data is expected to be available by the end of 2018.
Patient recruitment for the Company’s ongoing randomized, double-masked, sham controlled, multi-center Phase 2b clinical trial of Zimura for the treatment of geographic atrophy secondary to dry AMD is on track. The Company expects to complete recruitment in the third quarter of this year with initial top-line data expected to be available during the second half of 2019.
In January 2018, the Company started enrolling patients in a Phase 2b randomized, double-masked, sham-controlled, multi-center clinical trial assessing the efficacy and safety of Zimura in patients with autosomal recessive Stargardt disease (STGD1). Initial top-line data is expected to be available in 2020.
Gene Therapy Programs

The Company has initiated an innovative gene therapy program focused on applying novel gene therapy technology to discover and develop new therapies for ocular diseases.
In June 2018, the Company entered into an exclusive global license agreement with the University of Florida Research Foundation, Incorporated and the Trustees of the University of Pennsylvania (Penn) for rights to develop and commercialize a novel adeno-associated virus gene therapy product candidate for the treatment of rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP), an orphan monogenic disease. The construct for the RHO-adRP product candidate combines a transgene expressing a highly efficient novel short hairpin RNA (shRNA) designed to target and knock-down endogenous rhodopsin (RHO) in a mutation-independent manner with a human RHO replacement transgene made resistant to RNA interference, in a single adeno-associated viral (AAV 2/5) vector. Ophthotech and Penn have also entered into a master sponsored research agreement, facilitated by the Penn Center for Innovation, pursuant to which Ophthotech and Penn plan to conduct natural history studies in RHO-adRP patients and additional preclinical studies. In parallel with the sponsored research, Ophthotech plans to commence IND-enabling activities. Based on current timelines and subject to regulatory review, Ophthotech expects to initiate a Phase 1/2 clinical trial in RHO-adRP in 2020.
In February 2018, the Company entered into a series of sponsored research agreements with the University of Massachusetts Medical School (UMMS) and its Horae Gene Therapy Center to utilize their next generation "minigene" therapy approach for the potential treatment of orphan degenerative retinal diseases such as Leber Congenital Amaurosis (LCA) type 10 due to CEP290 mutations (the most common type of LCA), and autosomal recessive Stargardt disease (STGD1) due to ABCA4 mutations. Further, the Company and UMMS are also evaluating novel gene delivery methods to target retinal diseases. UMMS has granted Ophthotech an option to obtain an exclusive license to any patent or patent applications that result from this research.
2018 Operational Update

As of June 30, 2018, the Company had $146 million in cash and cash equivalents. The Company estimates that its year end 2018 cash and cash equivalents will range between $112 million and $117 million based on its current 2018 business plan and planned capital expenditures. This estimate includes continuation of the Company’s development programs for Zimura and RHO-adRP gene therapy product candidate and the continuation of the Company’s collaborative gene therapy research programs as currently planned.

This estimate does not reflect any additional expenditures resulting from the potential in-licensing or acquisition of additional product candidates or technologies or associated development that the Company may pursue.

2018 Financial Highlights

Revenues: The Company did not have any collaboration revenue for the quarter and six months ended June 30, 2018, compared to $1.7 million and $3.3 million for the same periods in 2017. Collaboration revenue decreased due to the completion of the Company’s deliverables under its previous licensing and commercialization agreement with Novartis Pharma AG and the recognition of all associated deferred revenue during the third quarter of 2017.
R&D Expenses: Research and development expenses were $8.5 million for the quarter ended June 30, 2018, compared to $15.7 million for the same period in 2017. For the six months ended June 30, 2018, research and development expenses were $16.2 million compared to $47.6 million for 2017. As the Company pursues its ongoing and planned Zimura and gene therapy development programs, research and development expenses decreased primarily due to decreases in expenses related to the discontinuation of the Company’s FovistaPhase 3 clinical program and decreases in costs associated with the Company’s 2017 reduction in personnel program.
G&A Expenses: General and administrative expenses were $6.3 million for the quarter ended June 30, 2018, compared to $8.6 million for the same period in 2017. For the six months ended June 30, 2018, general and administrative expenses were $12.0 million compared to $21.7 million for 2017. General and administrative expenses decreased primarily due to decreases in costs to support the Company’s operations and infrastructure and decreases in costs associated with its 2017 reduction in personnel program, which includes facilities lease termination expenses incurred during the first quarter of 2017.
Net Loss: The Company reported a net loss for the quarter ended June 30, 2018 of $13.2 million, or ($0.37) per diluted share, compared to a net loss of $22.2 million, or ($0.62) per diluted share, for the same period in 2017. For the six months ended June 30, 2018, the Company reported a net loss of $26.3 million, or ($0.73) per diluted share, compared to a net loss of $65.3 million, or ($1.82) per diluted share, for the same period in 2017.
Conference Call/Web Cast Information

Ophthotech will host a conference call/webcast to discuss the Company’s financial and operating results and provide a business update. The call is scheduled for August 1, 2018 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 800-458-4121 (USA) or 323-794-2597 (International), passcode 3698278. A live, listen-only audio webcast of the conference call can be accessed on the Investor Relations section of the Ophthotech website at: www.ophthotech.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA Toll Free), passcode 3698278.

On August 1, 2018 ArQule, Inc. (Nasdaq: ARQL) reported its financial results for the second quarter of 2018 (Press release, ArQule, AUG 1, 2018, View Source [SID1234528286]).

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For the quarter ended June 30, 2018, the Company reported net income of $5,156,000 or $0.05 per diluted share, compared with a net loss of $7,201,000 or $0.10 per basic share, for the second quarter of 2017. For the six-month period ended June 30, 2018, the Company reported a net loss of $1,376,000 or $0.02 per basic share, compared with a net loss of $14,777,000 or $0.21 per basic share, for the six-month period ended June 30, 2017.

As of June 30, 2018, the Company had a total of approximately $46,075,000 in cash, equivalents and marketable securities.

Key Highlights

In July 2018, the Company raised approximately $70 million of gross proceeds in a public offering of common stock. Net proceeds will be used to fund its core clinical programs and for general corporate purposes
ARQ 531, our potent and reversible BTK inhibitor, demonstrated good oral bioavailability, pharmacokinetics and early signs of activity in data presented at the European Hematological Association (EHA) (Free EHA Whitepaper) in June 2018. The Phase 1 portion of the Phase 1a/b trial continues to recruit on schedule, and we plan to present additional data at a major congress later in 2018
A comprehensive preclinical publication on ARQ 531 has been accepted in a major scientific journal
We and our academic collaborators at Memorial Sloan Kettering have initiated an expansion cohort for miransertib in combination with anastrazole in patients with endometrial cancer, and are targeting to enroll up to 40 patients in this cohort
We and our scientific collaborators have compiled a foundational clinical data set from miransertib in rare diseases that we plan to present at the American Society of Human Genetics (ASHG) Annual Meeting in October
"We were gratified by the high level of interest and quality of investors that participated in our recent public offering," said Paolo Pucci, Chief Executive Officer of ArQule. "Our core clinical programs continue to progress, and the capital we received in the upsized offering significantly enhances our ability to expand our plans and to sustain them over a longer period of time."

Brian Schwartz, M.D., Head of Research and Development and Chief Medical Officer of ArQule said, "We are pleased with the continued progress of our clinical programs in oncology and rare diseases. Data recently presented at EHA (Free EHA Whitepaper) on ARQ 531, our reversible BTK inhibitor, have further validated the potential of this promising drug candidate, and we are now planning for the next data releases in the second part of the year."

Revenues and Expenses

Revenues for the quarter ended June 30, 2018, were $13,706,000 compared with revenues of zero for the quarter ended June 30, 2017. Research and development revenue in the quarter ended June 30, 2018 consisted of $13,706,000 from our April 2018 Basilea licensing agreement.

Revenues for the six months ended June 30, 2018, were $17,844,000 compared with revenues of zero for the six months ended June 30, 2017. Research and development revenue in the six months ended June 30, 2018 consisted of $13,706,000 from our April 2018 Basilea licensing agreement, $3,000,000 from our February 2018 Roivant licensing agreement and $1,138,000 from our October 2017 non-exclusive license agreement for certain library compounds.

Research and development expense in the second quarter of 2018 was $6,787,000 compared with $4,983,000 for the second quarter of 2017. Research and development expense increased $1.8 million in the second quarter of 2018 primarily due to higher outsourced preclinical, clinical and product development costs.

Research and development expense in the six-months ended June 30, 2018 was $12,599,000 compared with $10,177,000 in the six months ended June 30, 2017. The $2.4 million increase in research and development expense in the six months ended June 30, 2018 was primarily due to higher outsourced preclinical, clinical and product development costs.

General and administrative expense was $2,234,000 in the second quarter of 2018 compared with $1,866,000 in the second quarter 2017. The $0.4 million increase in general and administrative expense in the three months ended June 30, 2018 was primarily due to increased professional fees.

General and administrative expense was $4,585,000 in the six months ended June 30, 2018 compared with $3,940,000 in the six months ended June 30, 2017. The $0.6 million increase in general and administrative expense in the six months ended June 30, 2018 was primarily due to increased professional fees and labor related costs.

2018 Updated Financial Guidance

As a result of the July 2018 stock offering and the prior conversion of our preferred stock into 8,370,000 shares of common stock, we have updated our 2018 guidance. For 2018, ArQule now expects revenue to range between $21 and $23 million. Net use of cash is expected to range between $28 and $30 million for the year. Net loss is expected to range between $10 and $14 million, and net loss per share to range between $(0.10) and $(0.14) for the year. ArQule expects to end 2018 with between $100 and $102 million in cash and marketable securities.

Conference Call and Webcast

ArQule will hold its second quarter 2018 financial results call today, August 1, 2018 at 9:00 a.m. ET. The live webcast can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events & Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investor and Media" section of our website, www.arqule.com, under "Events & Presentations."