On May 8, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ: OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported first quarter 2018 financial results and provided a corporate update (Press release, OncoMed, MAY 8, 2018, View Source [SID1234526253]). As of March 31, 2018, cash, cash equivalents, and short-term investments totaled $88.4 million.

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"The Company is encouraged by ongoing clinical progress on its two most advanced immuno-oncology programs, anti-TIGIT and GITRL-Fc, and preclinical data on these programs were recently highlighted in multiple poster presentations at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. We also continue to dose patients in two Phase 1b studies of navicixizumab, our anti-DLL4/VEGF bispecific antibody. We look forward to delivering on numerous near-term catalysts, including the initiation of the Phase 1b portion of the anti-TIGIT study in combination with anti-PD1 in the second quarter of this year, the publication of the navicixizumab Phase 1a manuscript and the presentation of the navicixizumab Phase 1b ovarian cancer data in the second half of 2018, and the planned presentation of the anti-TIGIT Phase 1a data in the fourth quarter of 2018," stated John Lewicki, Ph.D., President and CEO of OncoMed.

Pipeline Highlights

Anti-TIGIT (OMP-313M32)

OncoMed plans to initiate dosing of the Phase 1b portion of its Phase 1a/b anti-TIGIT (OMP-313M32) trial, in combination with anti-PD1, in the second quarter of 2018. The Phase 1b portion of the open-label clinical trial is designed to assess the safety, tolerability, preliminary efficacy, and pharmacodynamic biomarkers of escalating doses of OMP-313M32 in combination with anti-PD1 for the treatment of patients with solid tumors who have progressed after prior treatment with anti-PD1 or anti-PD-L1.

OncoMed continues enrollment in the Phase 1a single-agent study of anti-TIGIT in patients with advanced or metastatic solid tumors. The Phase 1a study is designed to assess safety and tolerability of escalating doses of anti-TIGIT. Biomarkers will be assessed in this study which includes a single-agent dose expansion cohort.

The company currently expects to present data from the Phase 1a portion of the Phase 1a/b study in the fourth quarter of 2018.

Navicixizumab (anti-DLL4/VEGF bispecific; OMP-305B83)

Enrollment continues in two Phase 1b multi-center, open-label, dose escalation and expansion studies of OncoMed’s anti-DLL4/VEGF bispecific antibody in combination with standard-of-care chemotherapies: one in patients with platinum-resistant ovarian cancer who have failed more than two prior therapies or prior bevacizumab and a second in patients with 2nd line metastatic colorectal cancer.

To date, OncoMed has enrolled approximately 100 patients across the Phase 1a and Phase 1b trials of navicixizumab.

The Phase 1a data are expected to be published in the second half of 2018, and interim data from the ongoing Phase 1b ovarian cancer study are also expected to be reported in the second half of 2018.

GITRL-Fc (OMP-336B11)

Robust enrollment continues in the Phase 1a single-agent study of its wholly-owned GITRL-Fc in patients with advanced or metastatic solid tumors. GITRL-Fc is a fusion protein with an Fc-linked fully human trimer ligand and is designed to activate the co-stimulatory receptor GITR (glucocorticoid-induced tumor necrosis factor receptor-related protein) to enhance T-cell modulated immune responses. The Phase 1a study is designed to assess safety and tolerability of escalating doses.

The Phase 1a data are expected to be presented in 2019.

New product discovery

OncoMed continues to make strong progress in its pursuit of novel immune-oncology agents, including emerging opportunities from the TNF superfamily of ligands, using the company’s proprietary linkerless fully human trimer technology.

First Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments totaled $88.4 million as of March 31, 2018, compared to $103.1 million as of December 31, 2017.

Revenues were $7.8 million for the first quarter of 2018, an increase of $1.6 million, compared to $6.2 million for the same period in 2017. The change in revenue was due to the effect of the adoption of the new revenue recognition standard in the first quarter of 2018. For further discussion regarding our adoption of the new revenue recognition standard and its effects, see page 12 of our Quarterly Report on Form 10-Q for the first quarter ended March 31, 2018, filed with the Securities and Exchange Commission on May 8, 2018.

Research and development (R&D) expenses were $8.4 million for the first quarter of 2018, a decrease of $15.6 million, compared to $24.0 million for the same period in 2017. The decrease in R&D expenses was due to decreases in clinical development costs and reduced headcount following the restructuring actions in April 2017.

General and administrative (G&A) expenses were $5.4 million for the first quarter of 2018, an increase of $0.4 million, compared to $5.0 million for the same period in 2017. The increase in G&A expenses was primarily due to an increase in personnel cost, including retention bonus and severance expenses in the first quarter of 2018, offset by a decrease in headcount as a result of restructuring actions in April 2017.

Net loss for the first quarter of 2018 was $5.6 million ($0.15 per share), compared to $22.6 million ($0.61 per share) for the same period of 2017. The change in year-over-year net loss was primarily due to lower operating expenses in the first quarter of 2018.

2018 Financial Guidance

OncoMed’s current cash is estimated to be sufficient to fund operations through at least the third quarter of 2019, without taking into account future potential milestone or opt-in payments from its partners. OncoMed estimates 2018 operating cash burn to be approximately $55 million, before considering potential milestone or opt-in payments.

On May 8, 2018 Sangamo Therapeutics, Inc. (NASDAQ: SGMO) reported first quarter 2018 financial results and recent accomplishments (Press release, Sangamo Therapeutics, MAY 8, 2018, View Source [SID1234526271]).

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"This is an exciting time for Sangamo; we expect potential clinical data readouts from 7 studies in 2018 and 2019, beginning in late summer of this year with anticipated data from our hemophilia A gene therapy and MPS II genome editing programs," said Sandy Macrae, CEO of Sangamo. "In order to realize the potential of our platform technologies, we recently raised additional capital to strengthen our balance sheet. This funding will allow us to retain and invest in valuable programs for development and potential commercialization, particularly in select therapeutic areas including inherited metabolic diseases, rare CNS disorders, and immunology."

Recent Highlights

Corporate

Strengthened balance sheet with public offering of common stock raising net proceeds of approximately $216 million

Established global collaboration and license agreement with Kite, a Gilead Company, for the development of next-generation cell therapies for oncology

Clinical

Treated the fourth patient in the SB-525 Phase 1/2 Alta Study for hemophilia A

Treated the fourth patient in the SB-913 Phase 1/2 CHAMPIONS Study for MPS II

Received Clinical Trial Authorization (CTA) from the MHRA of the U.K. for enrollment of subjects in the ongoing Phase 1/2 clinical trial of SB-FIX for hemophilia B. The CTA allows enrollment of adolescent patients, ages 12-17, once preliminary safety and efficacy have been demonstrated in adults

Awarded an $8 million grant from the California Institute of Regenerative Medicine (CIRM) to evaluate ST-400, a gene-edited cell therapy candidate, for the treatment of transfusion-dependent beta-thalassemia. ST-400 is being developed in collaboration with Bioverativ, a Sanofi Company

After demonstrating safety at the first dose cohort in the SB-913 MPS II clinical trial, amended Phase 1/2 study protocol for SB-318 MPS I trial to begin enrolling patients directly into the second dose cohort

Research

Publication of preclinical murine study data from MPS II in vivo genome editing program in the April 2018 issue of Molecular Therapy

Sangamo scientists or collaborators will deliver three oral and four poster presentations during the 21st Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) being held in Chicago, IL from May 16-19, 2018

First Quarter 2018 Financial Results

For the first quarter ended March 31, 2018, Sangamo reported a consolidated net loss of $20.2 million, or $0.23 per share, compared to a net loss of $16.6 million, or $0.23 per share, for the same period in 2017. As of March 31, 2018, the Company had cash, cash equivalents, marketable securities and interest receivable of $234.9 million. This balance does not include the $150 million upfront payment from the collaboration agreement with Kite, effective April 5th, or the approximately $216 million in net proceeds from the recent public offering of Sangamo’s common stock, which closed on April 30th.

Revenues for the first quarter ended March 31, 2018 were $12.6 million, compared to $3.4 million for the same period in 2017. The increase in revenues was primarily related to the hemophilia A collaboration and license agreement with Pfizer. First quarter 2018 revenues were primarily generated from Sangamo’s collaboration agreements with Pfizer and Bioverativ.

Total operating expenses for the first quarter ended March 31, 2018 were $33.6 million, compared to $20.2 million for the same period in 2017. Research and development expenses were $23.5 million for the first quarter of 2018, compared to $12.9 million for the same period in 2017. The increase was primarily due to clinical and manufacturing expenses in support of current clinical studies and investment in dedicated manufacturing capacity. General and administrative expenses were $10.1 million for the first quarter ended March 31, 2018, compared to $7.3 million for the same period in 2017. The increase was primarily due to salaries and related costs and other professional fees in support of overall Company growth.

Financial Guidance for 2018

The Company updates guidance as follows:

Operating Expenses: Sangamo expects that operating expenses will be in the range of $140 million to $150 million for year-end 2018, including non-cash stock-based compensation expense.

Cash and Investments: Sangamo expects a year-end 2018 balance of cash, cash equivalents, marketable securities and interest receivable of at least $485 million. This anticipated cash balance is inclusive of research funding from existing collaborators and recent financings, but exclusive of funds arising from any additional new collaborations or partnerships or other sources of capital.

Conference Call

Sangamo will host a conference call today, May 8, 2018, at 8:00 a.m. ET, which will be open to the public. The call will also be webcast live and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.

The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 1194369. For those unable to listen in at the designated time, a conference call replay will be available for one week following the conference call, from approximately 11:00 a.m. ET on May 8, 2018 to 11:00 a.m. ET on May 15, 2018. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 1194369.

On May 8, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) (Press release, Genmab, MAY 8, 2018, View Source [SID1234526185]). The supplemental Biologics License Application (sBLA) for this indication was submitted by Genmab’s licensing partner, Janssen Biotech, Inc., in November 2017. The U.S. FDA subsequently granted priority review to the sBLA, with a Prescription Drug User Fee Act (PDUFA) target date of May 21, 2018. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"With this label expansion, DARZALEX becomes the first antibody therapeutic to be approved for patients with newly diagnosed multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "This is an important step forward as it provides an additional treatment option to patients who are newly diagnosed with multiple myeloma."

The approval was based on data from the Phase III ALCYONE study that showed a reduction of the risk of disease progression or death by 50 percent (Hazard Ratio [HR] = 0.50; 95 percent CI [0.38-0.65], p<0.0001) in patients with newly diagnosed multiple myeloma ineligible for ASCT when daratumumab is combined with VMP. The safety of DARZALEX combination therapy was consistent with the known safety profiles of DARZALEX monotherapy and of therapy with bortezomib, melphalan and prednisone, respectively. This data was presented as a Late-Breaking Abstract at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine in December, 2017.

About the ALCYONE study
This Phase III study (NCT02195479) is a randomized, open-label, multicenter study that included 706 newly diagnosed patients with multiple myeloma who are ineligible for ASCT. Patients were randomized to receive 9 cycles of either VMP [bortezomib (a proteasome inhibitor), melphalan (an alkylating chemotherapeutic agent) and prednisone (a corticosteroid)] combined with daratumumab, or VMP alone. In the daratumumab treatment arm, patients received 16 mg/kg of daratumumab once weekly for six weeks (cycle 1; 1 cycle = 42 days), once every three weeks from cycles 2 to 9, and once every 4 weeks from cycle 9 until disease progression. The primary endpoint of the study is progression free survival (PFS).

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 30,770 new patients are expected to be diagnosed with multiple myeloma and approximately 12,770 people are expected to die from the disease in the U.S. in 2018.3 Globally, it was estimated that 124,225 people would be diagnosed and 87,084 would die from the disease in 2015.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,7,8,9,10

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and frontline multiple myeloma settings and in amyloidosis. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases, such as NKT-cell lymphoma, myelodysplastic syndromes, B and T-ALL and selected solid tumors. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.

On May 8, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology, and immunology, reported financial results for the first quarter 2018 and provided an update on its clinical development and commercial programs (Press release, Aclaris Therapeutics, MAY 8, 2018, View Source [SID1234526222]).

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"The first quarter of 2018 was a busy one as we prepared for the launch of ESKATA (hydrogen peroxide) Topical Solution, 40% (w/w), the first and only FDA-approved topical treatment for raised seborrheic keratosis (SK). We held the ESKATA Launch Meeting last week, and ESKATA is now officially available for physicians and their patients," said Brett Fair, Chief Commercial Officer of Aclaris.

Commercial Update:

Successful rollout and implementation of the ESKATA Early Experience Initiative (EEI).

Program expanded to over 700 accounts to accommodate market demand for ESKATA.

Ongoing in-service programs to support successful training and product integration.

Positive initial ESKATA feedback from EEI program captured in physician and patient post-application surveys.

Aclaris sales force successful in generating a significant number of ESKATA pre-orders from targeted accounts ahead of official launch meeting.

Commenced health care provider (HCP) order processing and shipping the week of April 23, 2018.

ESKATA Launch Campaign Highlights:

ESKATA Launch Meeting held April 30 – May 4, 2018; Unveiled New ESKATA Campaign; sales force trained on new tools and resources to support a successful ESKATA launch.

ESKATA Consumer website (www.eskata.com) launched May 1, 2018; includes "Find A Doctor" resource for patients seeking ESKATA treatment.

ESKATA HCP website (www.eskatahcp.com) updated with new campaign and downloadable tools/resources for offices.

ESKATA Peer-to-peer Speaker Programs beginning in May 2018.
"In March, we announced positive results from the 3-month follow-up portion of the WART-203 Phase 2 clinical trial of A-101 45% Topical Solution (A-101 45%) for the treatment of common warts (verruca vulgaris). We are also advancing our topical Janus kinase (JAK) inhibitor programs, with results from multiple Phase 2 trials expected this year. As our early-stage pipeline compounds advance towards the clinic, we continue to progress towards our goal of becoming a vertically integrated, commercial-stage biopharmaceutical company with a robust clinical-stage pipeline and drug discovery engine," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.

Clinical Pipeline Update:

A-101 45% Topical Solution

In March 2018, announced positive results from the 3-month, post-treatment, follow-up evaluation period of the twice-weekly placebo-controlled Phase 2 trial (WART-203) of A-101 45% Topical Solution (A-101 45%), an investigational new drug consisting of a proprietary high-concentration stabilized hydrogen peroxide topical solution being developed as a prescription treatment for common warts (verruca vulgaris).

Over the 3-month post-treatment follow-up period, clinically and statistically significant greater improvements in common wart reduction and clearance vs. placebo were observed among subjects treated with A-101 45%.

Scheduled an End of Phase 2 meeting with the FDA for mid-2018, and plan to initiate two pivotal Phase 3 trials in the second half of 2018.
JAK Inhibitor Candidates

AA-202 Topical – an ongoing Phase 2 clinical trial of ATI-502 for the topical treatment of alopecia areata (AA). This trial will evaluate the pharmacokinetics, pharmacodynamics and safety of ATI-502 compared with placebo in 12 patients with AA. This randomized, double-blind clinical trial is being conducted at two investigational centers within the United States, and topline data are expected in the first half of 2018. After completing the 28-day portion of the trial, patients will then enter a 6-month open label extension during which all patients will receive drug.

AUATB-201 Topical – an ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of AA. This trial will evaluate the effect of ATI-502 on the regrowth of eyebrows in up to 24 patients with AA. This trial is being conducted at two investigational centers in Sydney and Melbourne, Australia, and topline qualitative data are expected mid-2018.

AA-201 Topical – an ongoing Phase 2 dose ranging trial of ATI-502 for the topical treatment of AA. This trial will evaluate the effect of two concentrations of ATI-502 on the regrowth of hair in a randomized, double-blinded, parallel-group, vehicle-controlled trial in up to 120 patients with AA. This trial is being conducted in the United States and data are expected by year end 2018.

VITI-201 Topical – an ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of vitiligo. This trial will evaluate the effect of ATI-502 on the repigmentation of facial skin in up to 24 patients with vitiligo and data are expected in the first half of 2019.

AGA-201 Topical – an ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of androgenetic alopecia (AGA), also known as male/female pattern hair loss. This trial will evaluate the effect of ATI-502 on the regrowth of hair in up to 24 patients with AGA and data are expected in first half of 2019.

AUAT-201 Oral – a planned Phase 2 dose ranging trial of ATI-501, an oral JAK inhibitor for the treatment of AA, which is anticipated to begin in the first half of 2018. This trial will evaluate the effect of two concentrations of ATI-501 on the regrowth of hair in a randomized, double-blinded, parallel-group, vehicle-controlled trial in 120 to 160 patients with AA. This trial will be conducted in the United States and data are expected in mid-2019.
ATI-450 (MK-2 Inhibitor)

Investigational New Drug application on track for submission to the FDA in mid-2019.
Recent Corporate Highlights

Exclusively licensed the Canadian rights to commercialize A-101 40% Topical Solution for the treatment of raised seborrheic keratoses to Cipher Pharmaceuticals.

Appointed Bryan Reasons as a director and Chairman of the Audit Committee.
Financial Highlights

Liquidity and Capital Resources

As of March 31, 2018, Aclaris had aggregate cash, cash equivalents and marketable securities of $187.0 million compared to $208.9 million as of December 31, 2017. The $21.9 million decrease during the quarter ended March 31, 2018 included:

Net loss of $30.2 million, offset by $5.4 million of non-cash stock-based compensation expense, depreciation and amortization, $2.1 million of net cash provided by changes in operating assets and liabilities, and $0.9 million for a non-cash expense associated with an increase in the fair value of a contingent consideration liability.

$0.3 million of cash used for purchases of property and equipment.

$0.4 million in cash proceeds from the exercise of employee stock options.
Aclaris anticipates that its cash, cash equivalents and marketable securities as of March 31, 2018 will be sufficient to fund its operations into the second half of 2019, without giving effect to any potential new business development transactions or financing activities.

First Quarter 2018 Financial Results

Net loss was $30.2 million for the first quarter of 2018, compared to $12.6 million for the first quarter of 2017.

Revenue of $1.1 million and cost of revenue of $1.0 million for the first quarter of 2018 related to Aclaris’s contract research business acquired in August 2017.

Total operating expenses for the first quarter of 2018 were $31.1 million, compared to $12.9 million for the first quarter of 2017.
Research and development expenses were $13.6 million for the first quarter of 2018, compared to $7.8 million for the first quarter of 2017. The increase of $5.8 million was primarily attributable to a $2.7 million increase in expenses related to the preclinical and clinical development of Aclaris’s JAK inhibitor portfolio, a $1.3 million increase in medical affairs activities and early-stage drug discovery, a $0.9 million increase in fair value of the contingent consideration liability, a $0.8 million increase in Aclaris’s A-101 45% topical solution program as Phase 2 clinical trials were initiated in June 2017, and a $0.6 million increase in personnel-related expenses, including stock-based compensation, due to increased headcount. These increases were partially offset by a $0.5 million decrease in ESKATA development expenses in the first quarter of 2018.

Sales and marketing expenses were $11.2 million for the first quarter of 2018, compared to $1.4 million for the first quarter of 2017. The $9.8 million increase is mainly due to increases in direct marketing and professional fees, as well as other sales and marketing expenses of $5.8 million, in preparation for the commercial launch of ESKATA in the second quarter of 2018. Personnel expenses, including stock-based compensation, increased by $4.0 million as Aclaris completed the hiring of its field sales force in the first quarter of 2018.

General and administrative expenses were $6.3 million for the first quarter of 2018, compared to $3.7 million for the first quarter of 2017. The increase of $2.6 million was primarily attributable to $1.6 million in higher personnel-related expenses, including stock-based compensation, due to increased headcount, a $0.4 million increase in professional and legal fees, and a $0.5 million increase in facility, support and other general and administrative expenses.
2018 Financial Outlook

Aclaris reiterated its expected 2018 GAAP research and development (R&D) expenses to be in the range of $67 to $75 million, including estimated stock-based compensation of $9 million. The anticipated increase in R&D expenses in 2018 is mainly due to the planned execution of Phase 2 clinical trials in AA, AGA, and vitiligo, two planned pivotal Phase 3 trials in common warts, and the development of our early stage pipeline compounds.

Aclaris reiterated its expected 2018 GAAP selling, general and administrative (SG&A) expenses to be in the range of $80 to $86 million, including estimated stock-based compensation of $14 million. The anticipated increase in SG&A expenses in 2018 is primarily the result of the deployment of Aclaris’s new sales force in January 2018 and the additional selling, marketing and consumer initiatives to support the commercial launch of ESKATA.
Company to Host Conference Call
Management will conduct a conference call at 5:00 P.M. ET today to discuss Aclaris’ financial results and provide a general business update. The conference will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 7386579 prior to the start of the call

On May 8, 2018 OPKO Health, Inc. (NASDAQ: OPK) reported financial results and business highlights for the three months ended March 31, 2018 (Press release, Opko Health, MAY 8, 2018, View Source [SID1234526238]).

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Financial Highlights

Consolidated revenues for the three months ended March 31, 2018 were $254.9 million compared with $266.4 million for the comparable period of 2017.

Revenue from services were $211.3 million for the three months ended March 31, 2018 compared with $228.6 million for the comparable 2017 period. While not directly comparable, this represents a marked improvement from the most recently completed quarter ended December 31, 2017.

Revenue from products included $3.7 million of revenue from RAYALDEE during the first quarter of 2018. Revenues from RAYALDEE were deferred during the initial launch period so there is no prior-year comparison.
During the three months ended March 31, 2018, operating expenses included investment in commercial activities supporting the launch of RAYALDEE of $7.3 million and continued investment in our pharmaceutical pipeline, with R&D expense increasing $6.3 million to $32.9 million compared with $26.6 million for the 2017 period.

Net loss of $43.1 million or $0.08 per share during the three months ended March 31, 2018 compares with a net loss of $34.5 million or $0.06 per share for the comparable period of 2017

Cash, cash equivalents and marketable securities were $99.9 million as of March 31, 2018.

"We are pleased to report steady sequential-quarter growth for RAYALDEE and 4Kscore, as well as improvement in our lab business from Q4 of last year," said Phillip Frost, Chairman and Chief Executive Officer of OPKO Health. "The improved first quarter results were in line with our expectations, starting 2018 positively coming off challenging fourth quarter 2017 results. These factors, taken together, reflect progress across the breadth of our commercial and laboratory services."

Business Highlights

RAYALDEE total prescriptions reported by IMS for Q1 2018 increased 730% compared with Q1 2017 and 38% compared with Q4 2017: As of May 1, 2018, more than 79% of patients had access to RAYALDEE under their insurance plans.

4Kscore utilization in Q1 2018 increased 13% compared with Q1 2017: Five abstracts of studies further demonstrating the utility of the 4Kscore test in the management of prostate cancer are to be presented at the American Urological Association meeting May 18-21.

Appointed Geoff Monk as General Manager, BioReference Laboratories: Mr. Monk is well prepared to lead BRL with more than 20 years of management experience in the diagnostic laboratory business. Mr. Monk was previously Managing Director of the New York and New Jersey unit of Quest Diagnostics.

Advanced the Phase 2b trial for our SARM (selective androgen receptor modulator) to treat benign prostatic hyperplasia (BPH): Enrollment is ongoing in this dose-ranging study for our orally administered SARM. This medicine is expected to improve the symptoms of BPH by reducing prostate size and, on the basis of data from a previous trial in 350 men, increase muscle mass and bone strength and decrease body fat. BPH affects approximately 50 million men in the U.S.

Initiated a Phase 2b clinical trial for OPK88003, our once-weekly oxyntomodulin dual GLP1-Glucagon agonist to treat type 2 diabetes and obesity: In a previous Phase 2 trial in 420 overweight patients with type 2 diabetes, the drug was shown to be safe and effective. The current trial is to study a new dosing schedule to achieve even greater weight loss.

Premarket Approval (PMA) application for Claros point-of-care PSA test under review by FDA: OPKO has submitted a PMA for a PSA test utilizing the Claros 1 immunoassay analyzer, a novel diagnostic instrument that can provide rapid, quantitative blood test results in 10 minutes in the physician’s office with only a finger stick drop of whole blood. A second product utilizing the Claros platform to measure testosterone is advancing toward a 510(k) submission to the FDA later this year.

Global and Japanese Phase 3 registration trials for hGH-CTP in pediatric growth hormone deficient children are continuing to enroll patients: The global pediatric study compares a single weekly administration with daily injections of a currently marketed growth hormone product. The global and Japanese pediatric studies utilize the pen device and formulation that will be launched commercially upon approval. The pediatric segment represents more than 80% of the market for treatment of hGH deficiency.

Initiation of three additional Phase 2 clinical trials are anticipated in 2018:

RAYALDEE line extension in dialysis patients with secondary hyperparathyroidism (SHPT): Together with our partners, Vifor Fresenius and Japan Tobacco, OPKO is developing RAYALDEE for Stage 5 chronic kidney disease (CKD) patients with SHPT undergoing dialysis and anticipates initiating a global Phase 2 trial during Q3 of this year.

OPKO’s NK-1 antagonist to treat pruritus (itching) in Stage 5 CKD patients undergoing dialysis: An Investigational New Drug application was submitted to the FDA and plans are being finalized to begin a single-dose Phase 2a trial in dialysis patients to treat severe itching. Approximately 50% of renal dialysis patients experience pruritus.

OPKO’s AntagoNAT oligonucleotide OPK88001 to treat Dravet’s syndrome: Three clinical research centers in the United States are expected to participate in this first-in-human trial of OPKO’s AntagoNAT to treat Dravet’s syndrome.
Conference Call & Webcast Information

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time today. The conference call dial-in and webcast information is as follows:

WHEN: Tuesday, May 8, 2018 at 4:30 p.m. Eastern time.
DOMESTIC DIAL-IN: 866-634-2258
INTERNATIONAL DIAL-IN : 330-863-3454
PASSCODE: 5976529
WEBCAST: View Source

For those unable to participate in the live conference call or webcast, a replay will be available beginning May 8, 2018 two hours after the close of the conference call. To access the replay, dial (855) 859-2056 or (404) 537-3406. The replay passcode is: 5976529. The replay can be accessed for a period of time on OPKO’s website at View Source.