On August 03, 2016 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy for treatment of cancer, reported that it has received notice from the U.S. Food and Drug administration that a partial clinical hold has been placed on its planned pivotal study of NY-ESO SPEAR T-cell therapy in myxoid round cell liposarcoma (MRCLS) (Press release, Adaptimmune, AUG 3, 2016, View Source;p=RssLanding&cat=news&id=2192667 [SID:1234514215]). This trial is not yet active at any investigational sites, and has not recruited any patients. This notification of partial clinical hold does not apply to any other Adaptimmune study.

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The FDA notification is not based on safety concerns. In its correspondence, the FDA requested additional CMC information and answers to certain trial design questions prior to the trial start. Adaptimmune intends to provide a full response to the FDA shortly.

"Adaptimmune is running a number of different studies with its NY-ESO program and continues to enroll patients in synovial sarcoma, ovarian, and lung cancer trials in the U.S.," said James Noble, Adaptimmune CEO. "We have been in dialogue with the FDA since achieving breakthrough status earlier this year and this partial clinical hold requires a number of questions to be answered before we can start a new MRCLS trial intended to be used for registration purposes. We will be providing a full response to the FDA shortly and will update the markets when we have further news to report."

The company will discuss this notice of partial clinical hold during its conference call to discuss the second quarter ended June 30, 2016, scheduled for 8:00 a.m. Eastern Time (1:00 p.m. BST) on Monday August 8, 2016.

On August 3, 2016 Geron Corporation (Nasdaq:GERN) reported financial results for the three and six months ended June 30, 2016 and recent events (Press release, Geron, AUG 3, 2016, View Source;p=irol-newsArticle&ID=2192600 [SID:1234514221]).

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For the second quarter of 2016, the company reported a net loss of $8.6 million, or $0.05 per share, compared to $9.4 million, or $0.06 per share, for the comparable 2015 period. Net loss for the first six months of 2016 was $17.5 million, or $0.11 per share, compared to $18.7 million, or $0.12 per share, for the comparable 2015 period. The company ended the second quarter of 2016 with $136.4 million in cash and investments and has not incurred any impairment charges on its marketable securities portfolio.

Revenues for the three and six months ended June 30, 2016 were $211,000 and $960,000, respectively, compared to $251,000 and $788,000 for the comparable 2015 periods. Revenues for the three and six month periods ending June 30, 2016 and 2015 included royalty and license fee revenues under various non-imetelstat license agreements.

Total operating expenses for the three and six months ended June 30, 2016 were $9.1 million and $18.9 million, respectively, compared to $9.7 million and $19.7 million for the comparable 2015 periods. Research and development expenses for the three and six months ended June 30, 2016 were $4.6 million and $9.6 million, respectively, compared to $4.8 million and $9.8 million for the comparable 2015 periods. General and administrative expenses for the three and six months ended June 30, 2016 were $4.5 million and $9.3 million, respectively, compared to $4.0 million and $8.6 million for the comparable 2015 periods. Operating expenses for the three and six months ended June 30, 2015 also included restructuring charges of $941,000 and $1.3 million, respectively, in connection with the company’s organizational resizing announced in March 2015.

The decrease in research and development expenses for the three and six month periods ending June 30, 2016, compared to the same periods in 2015, primarily reflects the net result of reduced personnel-related costs resulting from the March 2015 organizational resizing and lower costs for the manufacturing of imetelstat drug product, partially offset by higher costs for the company’s proportionate share of clinical development expenses under the imetelstat collaboration with Janssen Biotech, Inc. (Janssen). The company expects research and development expenses to increase during the remainder of the year as the clinical development of imetelstat continues in collaboration with Janssen. The increase in general and administrative expenses for the three and six month periods ending June 30, 2016, compared to the same periods in 2015, primarily reflects higher non-cash stock-based compensation expense and increased allocation of facilities and other overhead costs to general and administrative activities.

Interest and other income for the three and six months ended June 30, 2016 was $293,000 and $549,000, respectively, compared to $145,000 and $294,000 for the comparable 2015 periods. The increase in interest and other income for the three and six month periods ending June 30, 2016, compared to the same periods in 2015, primarily reflects higher yields on the company’s marketable securities portfolio.

Recent Company Events

In July 2016, three U.S. patents related to imetelstat were issued by the U.S. Patent and Trademark Office. U.S. 9,375,485 has claims covering the use of telomerase inhibitor compounds, including imetelstat, for alleviating at least one symptom of myelofibrosis or myelodysplastic syndromes, including chronic myelomonocytic leukemia, and is expected to remain in force until at least March 2033. U.S. 9,388,415 and U.S. 9,388,416 have claims covering methods for using imetelstat to inhibit the activity of telomerase and using imetelstat to inhibit cancer cell proliferation, as well as methods for using imetelstat to treat cancer, and are expected to remain in force until at least September 2024. These patents are related to Geron’s existing imetelstat composition of matter patent U.S. 7,494,982, which issued in 2009 and is expected to remain in force until at least December 2025. Further extension of patent terms may be available for regulatory review periods.

Geron’s portfolio of patents related to imetelstat and related products whose mechanism of action is telomerase inhibition have been licensed to Janssen under an exclusive worldwide license and collaboration agreement for all human disorders or medical conditions.

On August 3, 2016 XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, reported recent achievements and financial results for the second quarter ended June 30, 2016 (Press release, Xoma, AUG 3, 2016, View Source [SID:1234514339]).

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"The second quarter of 2016 marked our full transition to a solely endocrine-focused business as we have concluded all biodefense and Servier activities. During the quarter, we strategically focused on two antibody programs that are addressing areas of significant unmet medical need in endocrinology and that could create significant value for XOMA," said John Varian, Chief Executive Officer of XOMA. "First, we continued to advance our Phase 2 proof-of-concept study of XOMA 358 in the United States and EU in patients with hypoglycemia due to congenital hyperinsulinism. We also initiated a Phase 2 proof-of-concept study of XOMA 358 in patients who experience severe hypoglycemia following gastric bypass surgery. We remain on track to provide an update on our clinical experience with this first-in-class compound later this summer."

"Additionally, we advanced our second endocrine-focused asset into mid-stage clinical development with the initiation of a Phase 2 proof-of-concept study of XOMA 213 to confirm its ability to curtail prolactin signaling. This monoclonal antibody could be an important therapeutic option for people with prolactinomas, benign tumors of the pituitary gland, who do not respond to or are intolerant to current standard of care medications."

Recent Achievements

Received Orphan Drug Designation in the European Union for XOMA 358 for the treatment of congenital hyperinsulinism, a rare genetic disorder in which the insulin cells of the pancreas (beta cells) secrete inappropriate and excessive insulin
Initiated XOMA 358 proof-of-concept study in patients with hypoglycemia post gastric bypass surgery, representing the second rare hypoglycemic indication in which this first-in-class insulin receptor antibody is being studied
Initiated an open-label, mechanism of action, single-dose, multi-center Phase 2 proof-of-concept study of XOMA 213
Second Quarter 2016 Financial Results
XOMA recorded total revenues of $0.4 million for the three months ended June 30, 2016, compared with $2.5 million during the corresponding period of 2015. The decrease in second quarter 2016 revenues was due primarily to decreased revenues from the National Institute of Allergy and Infectious Diseases (NIAID) and Servier due to the Company’s decision to eliminate its non-endocrine assets. Going forward, revenues are expected to result from potential new transactions or payments under existing contracts.

Research and development (R&D) expenses for the second quarter of 2016 were $13.7 million, compared with $19.7 million in the corresponding 2015 period. The decrease was due primarily to a $3.9 million reduction in salaries and related expenses, a $1.2 million reduction in clinical trial costs, and a $0.9 million reduction in outside consulting fees due to the termination of the Servier Phase 3 program, partially offset by an increase of over $2.0 million in manufacturing costs related to the production of XOMA 358 material for the use in future clinical trials.

Selling, general and administrative expenses (SG&A) were $4.8 million for the three months ended June 30, 2016, compared with $5.1 million incurred during the same period in 2015, reflecting reduced salary and related personnel costs following the Company’s restructuring activities that were initiated in the third quarter of 2015.

For the second quarter ended June 30, 2016, XOMA had a net loss of $15.2 million, compared with a net loss of $23.8 million in the quarter ended June 30, 2015. The net losses in the three months ended June 30, 2016 and 2015, included a $3.3 million gain and $0.2 million loss, respectively, in non-cash revaluations of contingent warrant liabilities, resulting primarily from fluctuations in XOMA’s stock price. Excluding those revaluations, the net loss for the three months ended June 30, 2016, was $18.5 million, compared with a net loss of $23.6 million for the same reporting period in 2015.

On June 30, 2016, XOMA had cash and cash equivalents of $33.9 million compared with $65.8 million at December 31, 2015.

The Company expects its available capital will be sufficient to fund operations through at least the first quarter of 2017.

About XOMA 358
Insulin is the major physiologic hormone for controlling blood glucose levels. Abnormal increases in insulin secretion can lead to profound hypoglycemia (low blood sugar), a state that can result in significant morbidities, including brain damage, seizures and epilepsy. XOMA, leveraging its scientific expertise in allosteric monoclonal antibodies, developed the XMet platform, consisting of separate classes of selective insulin receptor modulators (SIRMs) that could have a major effect on treating patients with abnormal metabolic states. XOMA 358 binds selectively to insulin receptors and attenuates insulin action.

XOMA 358 is being investigated as a novel treatment for non-drug-induced, endogenous hyperinsulinemic hypoglycemia, as well as hypoglycemia after bariatric surgery and other related disorders. XOMA recently initiated Phase 2 development activities for XOMA 358. One Phase 2 study is being conducted in patients with congenital hyperinsulinism at The Children’s Hospital in Philadelphia (CHOP) and the Great Ormond Street Hospital (GOSH) in London. A second multi-center Phase 2 study is being conducted in patients who experience hypoglycemia post gastric bypass surgery. A therapy that safely and effectively mitigates insulin-induced hypoglycemia has the potential to address a significant unmet therapeutic need for certain rare medical conditions associated with hyperinsulinism. More information on the XOMA 358 clinical trial may be found at www.clinicaltrials.gov and www.clinicaltrialsregister.eu.

About Congenital Hyperinsulinismi, ii, iii, iv
Congenital Hyperinsulinism (CHI) is a genetic disorder in which the insulin cells of the pancreas (beta cells) secrete inappropriate and excessive insulin. Ordinarily, beta cells secrete just enough insulin to keep blood sugar in the normal range. In people with CHI, the secretion of insulin is not properly regulated, causing excess insulin secretion and frequent episodes of low blood sugar (hypoglycemia). In infants and young children, these episodes are characterized by a lack of energy (lethargy), irritability or difficulty feeding. Repeated episodes of low blood sugar increase the risk for serious complications, such as breathing difficulties, seizures, intellectual disability, vision loss, brain damage, coma, and possibly death. About 60 percent of infants with CHI experience a hypoglycemic episode within the first month of life. Other affected children develop hypoglycemia by early childhood. Current treatments for CHI are limited to medical therapy and surgical removal of part or all of the pancreas (pancreatectomy).

About Hypoglycemia Post Gastric Bypass Surgery
As the number of gastric bypass surgeries to treat severe obesity has increased, so too has the awareness that this population may experience postprandial hypoglycemia (low blood glucose following a meal) with symptoms developing months or years following the gastric bypass surgery. Postprandial hypoglycemia occurs with a range of severity in post-gastric bypass patients. The mild end of the spectrum may be managed largely through diet modification. The most severe forms are more prevalent in patients who underwent a Roux-en-Y procedure, and result in severe refractory postprandial hyperinsulinemic hypoglycemia with neuroglycopenic symptoms (altered mental status, loss of consciousness, seizures) that cannot be managed through diet modification. If currently available pharmacologic agents do not resolve the condition, these patients are treated with either a partial pancreatectomy or reversal of the gastric bypass.

About XOMA 213
XOMA 213 (formerly LFA 102) is a monoclonal antibody that neutralizes prolactin-induced signaling. Prolactin is a protein that in normal post-partum females enables the production of milk. XOMA 213 is being developed for diseases of hyperprolactinemia — specifically, prolactinomas, benign tumors of the pituitary gland that have serious medical consequences, particularly sexual dysfunction, infertility and osteoporosis. Prolactinomas also can lead to anti-psychotic-induced hyperprolactinemia, a side effect seen in patients treated with commonly used antipsychotics, antidepressants, and pain medications. Ten to twenty percent of patients do not respond to or are intolerant of current standard of care medications.

On August 03, 2016 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported financial results for the second quarter ended June 30, 2016 (Press release, Loxo Oncology, AUG 3, 2016, View Source [SID:1234514192]). Loxo Oncology will not be conducting a conference call in conjunction with this earnings release.

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"We had a productive second quarter," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "In April, we provided an important durability update for our adult Phase 1 LOXO-101 trial at AACR (Free AACR Whitepaper), and published our first pediatric response to LOXO-101 in a peer-reviewed journal. In May, we added new investors with a follow-on financing. In June, we presented data on our pediatric formulation and development plans to an FDA advisory committee, in a public forum. And just after the close of the quarter, we secured Breakthrough Therapy Designation for LOXO-101 from the FDA."

Recent Highlights

LOXO-101 Received Breakthrough Therapy Designation: In July, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to LOXO-101 "for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments."
LOXO-101 Selected for FDA Pediatric Advisory Committee Meeting: In June, Loxo Oncology participated in a meeting of the FDA’s Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The purpose of the meeting was to improve and encourage the development of oncology and hematology drugs for pediatric use. A replay of that presentation is available. Loxo Oncology also submitted a briefing package in advance of this meeting, which is publicly available.
Strengthened Balance Sheet: Loxo Oncology raised $41.4 million in gross proceeds in an equity financing in May 2016. Loxo Oncology’s cash, cash equivalents and investments are expected to be sufficient to fund operations into late 2018.
LOXO-101 Update at AACR (Free AACR Whitepaper) and Pediatric Case Report: In April, investigators provided an update of the Phase 1 adult trial of LOXO-101, highlighting patients with TRK fusion cancers. Of note from the presentation, all responding patients remained in response, all had shown evidence of tumor regression, and five of six patients had achieved a confirmed partial response (PR) by standard RECIST criteria. Importantly, five of these six patients were treated at or below the recommended Phase 2 dose. Separately, investigators also published a peer-reviewed case report of the first pediatric patient treated with a liquid formulation of LOXO-101 in the setting of infantile fibrosarcoma. The patient achieved a confirmed partial response and began again to achieve appropriate developmental milestones.
Upcoming Milestones

Loxo Oncology continues to make significant progress across its drug development pipeline. Upcoming milestones are expected to include:

Continued enrollment of the LOXO-101 NAVIGATE Phase 2 global, multi-center, single-arm, open-label basket trial in adult patients with solid tumors that harbor a TRK fusion. Loxo Oncology plans to provide an enrollment update in the second half of 2016.
Initiation of a Phase 1 study of a selective RET inhibitor in late 2016/ early 2017.
Initiation of a Phase 1 study of next-generation TRK inhibitor LOXO-195, addressing previously treated patients with acquired resistance, in 2017. Loxo Oncology may provide access to LOXO-195 for emergency investigational use prior to 2017 if medically necessary, requested by a treating clinician, and authorized by the appropriate regulatory authorities. LOXO-195 is designed to retain potency against a common resistance mutation that has been described in two separate patients who have progressed on a competitor’s TRK inhibitor.
Second Quarter 2016 Financial Results

As of June 30, 2016, Loxo Oncology had aggregate cash, cash equivalents and investments of $171.7 million, compared to $153.9 million as of December 31, 2015.

Loxo Oncology continues to expect cash burn of $48 to $52 million in 2016. Based on the current operating plan, the company believes existing capital resources will be sufficient to fund anticipated operations into late 2018.

Research and development expenses were $12.3 million for the second quarter of 2016 compared to $5.7 million for the second quarter of 2015. This increase was primarily due to expanded clinical development activities for LOXO-101, as well as additional expenses related to the preclinical pipeline. Loxo Oncology also recognized research and development-related stock-based compensation expense of $0.2 million during the second quarter of 2016, compared to $0.9 million for the second quarter of 2015.

Research and development expenses were $20.7 million for the six months ended June 30, 2016, compared to $9.5 million for the six months ended June 30, 2015. This increase was primarily due to expanded clinical development activities for LOXO-101, as well as additional expenses related to the preclinical pipeline. Loxo Oncology also recognized research and development-related stock-based compensation expense of $0.5 million during the six months ended June 30, 2016, compared to $1.3 million for the six months ended June 30, 2015.

General and administrative expenses were $3.8 million for the second quarter of 2016 compared to $2.4 million for the second quarter of 2015. This increase was primarily attributable to employment costs and professional fees. Loxo Oncology also recognized general and administrative-related stock-based compensation expense of $1.1 million during the second quarter 2016, compared to $0.8 million for the second quarter 2015.

General and administrative expenses were $7.2 million for the six months ended June 30, 2016, compared to $4.8 million for the six months ended June 30, 2015. This increase was primarily attributable to employment costs and professional fees. Loxo Oncology also recognized general and administrative-related stock-based compensation expense of $2.1 million during the six months ended June 30, 2016, compared to $1.3 million for the six months ended June 30, 2015.

Net loss was $15.9 million and $27.5 million for the three and six months ended June 30, 2016, respectively, compared to $8.1 million and $14.2 million for the three and six months ended June 30, 2015, respectively.

About LOXO-101
LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in the NAVIGATE global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions and the SCOUT Phase 1 trial in pediatric patients including infantile fibrosarcoma. LOXO-101 has been granted Breakthrough Therapy Designation by the U.S. FDA. For additional information about the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com.

On August 3, 2016 Vitae Pharmaceuticals, Inc. (NASDAQ:VTAE), a clinical-stage biotechnology company, reported its operating and financial results for the quarter ended June 30, 2016 (Press release, Vitae Pharmaceuticals, AUG 3, 2016, View Source;p=irol-newsArticle&ID=2192602 [SID:1234514222]).

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Jeff Hatfield, President and Chief Executive Officer of Vitae, commented, "During the quarter, we made significant progress towards the completion of two key milestones for Vitae. First, we are on track to report top-line results for the ongoing Phase 2a proof-of-concept study for VTP-38543, our wholly owned, potential first-in-class LXRβ selective agonist being developed for atopic dermatitis, in the fourth quarter of 2016. Second, we continue to finalize plans for the next clinical trial, expected to initiate in the fourth quarter of 2016, of VTP-43742, our wholly owned, first-in-class RORyt inhibitor, in psoriasis patients. Previously, VTP-43742 demonstrated results that validated RORyt as a therapeutic target for psoriasis and VTP-43742 as a potentially paradigm-changing therapeutic."

Quarterly and Recent Highlights

Pipeline Updates:

VTP-38543 in Atopic Dermatitis

Continued enrollment in its Phase 2a proof-of-concept clinical trial of VTP-38543 in atopic dermatitis. This four-week, randomized, double-blind, placebo-controlled Phase 2a trial will assess the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of multiple ascending topical doses of VTP-38543 in approximately 100 adult patients with mild to moderate atopic dermatitis. Vitae expects to report top-line efficacy results in the fourth quarter of 2016.
VTP-43742 in Autoimmune Disorders

Continued preparations for an upcoming Phase 2 clinical trial of VTP-43742 in psoriasis patients. Vitae plans to advance VTP-43742 into a 16-week Phase 2 trial in the fourth quarter of 2016 with the objectives of: (1) assessing the 16-week efficacy of VTP-43742 in moderate to severe psoriasis patients; (2) assessing the safety of the product candidate in a larger population and over a longer treatment period; and (3) positioning VTP-43742 to begin pivotal trials as soon as practicable after the completion of the Phase 2 clinical trial, if successful. Vitae expects to report top-line data from this trial in the second half of 2017.
VTP-45489 in Autoimmune Disorders

Vitae is advancing VTP-45489, its second RORyt inhibitor, into the clinic. Vitae expects to initiate a Phase 1 single ascending dose clinical trial in normal healthy volunteers during the third quarter of 2016.
New Contour Program

Animal proof-of-principle achieved in a new target program. Initial lead candidate selected to advance into preclinical development.
Corporate Update:

Appointed Carole Sable, M.D., as Chief Medical Officer. Dr. Sable will oversee the clinical development of Vitae’s pipeline, including VTP-43742 and VTP-38543. Dr. Sable brings to Vitae more than 20 years of diverse clinical development and executive management experience, having been involved in all phases of clinical research.

Appointed Daniel M. Junius to Vitae’s Board of Directors. Mr. Junius recently retired as President and Chief Executive Officer of ImmunoGen, Inc. and brings both executive and prior board experience to Vitae’s Board of Directors.
Financial Results:

Operating Expense. Total operating expenses for the second quarter of 2016 were $10.5 million, compared with $10.0 million for the second quarter of 2015.
Research and development expenses were $7.9 million for the second quarter of 2016, compared with $7.8 million for the second quarter of 2015. The slight increase was largely attributable to expenses related to preclinical programs, the atopic dermatitis program, discovery efforts, stock-based compensation and compensation expense, partially offset by reduced manufacturing expenses resulting from the timing of development activities for the RORyt program.
General and administrative expenses were $2.7 million for the second quarter of 2016, compared with $2.3 million for the second quarter of 2015. The increase was primarily due to an increase in legal fees, patent related expenses, stock-based compensation expense and compensation expenses.

Net Loss. Vitae reported a net loss of $10.4 million, or $0.36 per diluted share, for the second quarter of 2016, compared with a net loss of $9.8 million, or $0.45 per diluted share, for the second quarter of 2015. The increase in net loss was primarily due to the increase in general and administrative expenses.

Cash Position. As of June 30, 2016, Vitae had $77.4 million in cash, cash equivalents and marketable securities, compared with $59.4 million as of December 31, 2015. The increase in cash position was primarily a result of the completion of a follow-on public offering in March 2016, partially offset by cash outflows used in operating activities. Based on its current business plan, Vitae believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its projected operating requirements into the second half of 2018.
Expected Upcoming Events

VTP-38543 in Atopic Dermatitis – Top-line proof-of-concept results from a Phase 2a clinical trial in mild to moderate atopic dermatitis patients in the fourth quarter of 2016.

VTP-43742 in Autoimmune Disorders – Initiation of a 16-week Phase 2 trial in the fourth quarter of 2016.

VTP-45489 in Autoimmune Disorders – Initiation of a Phase 1 single ascending dose trial in the third quarter of 2016.