On August 7, 2018 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial results for the second quarter ended June 30, 2018 and provided a business update (Press release, Radius, AUG 7, 2018, View Source [SID1234528669]).

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"We are very pleased to report our continued progress in increasing the U.S. anabolic osteoporosis market share for TYMLOS and remain on track to meet our market share guidance for the year. We are also excited to see continued growth in the U.S. anabolic market since the launch of TYMLOS. Bone building anabolic therapies can offer significant benefits to high risk osteoporosis patients and are increasingly recommended by KOLs for use in this large and under-served patient population," said Jesper Hoeiland, President and Chief Executive Officer of Radius.

"We are on track to deliver on our key milestones and advance our clinical pipeline forward," Mr. Hoeiland concluded.

TYMLOS (abaloparatide) injection

Second quarter 2018 sales of TYMLOS in the U.S. were $22.6 million, an increase of 56% from the first quarter of 2018. TYMLOS prescriptions accounted for on average 19% of the total U.S. anabolic osteoporosis market (based on Patient Months on Therapy, TRx PMOT) and reached 34% of new anabolic patient starts (based on New Patients to Brand, NBRx PMOT).

TYMLOS U.S. market access increased to approximately 265 million covered lives. This represents 95% coverage in Commercial and Medicaid/All Other; and 44% coverage in Medicare Part D for a total of 88% of the U.S. insured population. In Commercial, the access has led to a monthly growth in total prescriptions of 257% in June 2018 compared to December 2017.
In June 2018, the U.S. Food and Drug Administration (FDA) approved a labeling supplement for TYMLOS to revise the needle length in the Instructions for Use from 8 mm to 5 to 8 mm. The Company believes health care providers, specialty pharmacies, and patients may prefer a shorter needle size for injectable products like TYMLOS.
Radius maintains its guidance for TYMLOS to capture on average 19-21% of the U.S. anabolic osteoporosis market in 2018. Based on the continued growth trajectory of the anabolic market since TYMLOS launched in May 2017, Radius now expects the U.S. anabolic market to grow at 7-9% in volume versus 2017.
Pipeline Highlights

Abaloparatide-Transdermal Patch (abaloparatide-patch)

At its Osteoporosis Investor Day event on June 8th, Radius presented further analyses of clinical and modelling data from its abaloparatide-patch program that support the Company’s Phase 3 trial’s primary objective of achieving BMD (bone mineral density) non-inferiority to abaloparatide-SC. Radius is on track with its preparation for the Phase 3 trial and expects to start the study in mid-2019.
Abaloparatide – Subcutaneous (SC)

Publication of ACTIVExtend Phase 3 data
In May 2018, results from the ACTIVExtend Study were published in The Journal of Clinical Endocrinology & Metabolism (JCEM). The significant reduction in the incidence of fractures seen from treatment with TYMLOS for 18 months in the ACTIVE Phase 3 Study was maintained in patients who received follow-up alendronate therapy for two years. At the 43-month timepoint, the previous TYMLOS-treated patients had a significant 84 percent relative risk reduction (p<0.0001) in vertebral fractures and a 39% risk reduction in nonvertebral fractures (p=0.038). The Company submitted a labeling supplement to the FDA in connection with the ACTIVExtend results in December 2017.
Histomorphometry Study
In July 2018, Radius initiated a bone histomorphometry study, which will enroll approximately 25 postmenopausal women with osteoporosis to evaluate the early effects of TYMLOS on tissue-based bone remodeling and structural indices. The study is designed to help understand and differentiate early effects of TYMLOS on bone formation and structure.

CHMP Opinion
In July 2018, Radius announced that, following a re-examination procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency had communicated a negative trend vote for the Company’s MAA for abaloparatide-SC for the treatment of osteoporosis in postmenopausal women at increased risk for fracture. On July 27, 2018, the CHMP communicated that it maintained its negative opinion on the MAA at its formal final vote. Radius will continue its efforts to make abaloparatide-SC available outside the U.S., via its collaboration with Teijin Limited in Japan and in other markets through partnership agreements.
Elacestrant (RAD1901)

Based on EMA and FDA feedback, Radius currently intends to conduct a single, randomized, comparator controlled Phase 3 trial of elacestrant as a third-line monotherapy in approximately 300 patients with ER positive/HER2 negative advanced/metastatic breast cancer. Depending on the results, this study is expected to support applications for global marketing approvals for elacestrant. Patients in the study would be randomized to receive either elacestrant or an investigator’s choice of an approved hormonal agent and the primary endpoint of the study will be progression-free survival (PFS). Start-up activities for the randomized study are well underway and Radius will provide further study details when the Phase 3 trial is initiated, which the Company expects will be in the second half of 2018.
RAD140

Patient enrollment is ongoing in the Phase 1 study evaluating the safety and maximum tolerated dose of RAD140, a nonsteroidal selective androgen receptor modulator (SARM), in patients with hormone receptor-positive, locally advanced or metastatic breast cancer. The Company expects to provide an update on the RAD140 development program by the end of 2018.
Anticipated Upcoming Milestones

Elacestrant
Initiate a Phase 3 clinical trial as third-line monotherapy in advanced/metastatic ER-positive/HER2-negative breast cancer patients in the second half of 2018.
Collaboration agreement for elacestrant combination therapy
RAD140
Continue enrollment in the Phase 1 study and provide a program update by the end of 2018

Abaloparatide
Enter into a partnership for the potential commercialization of abaloparatide-SC outside the U.S. and Japan
Expected Radius Presentations at Upcoming Conferences in Q3 2018

On September 12-14, the Company will present and host one-on-one meetings at the Morgan Stanley 16th Annual Global Healthcare Conference in New York, NY.
Second Quarter 2018 Financial Results

Three Months Ended June 30, 2018

For the three months ended June 30, 2018, Radius reported a net loss of $68.9 million, or $1.52 per share, compared to a net loss of $68.4 million, or $1.58 per share, for the three months ended June 30, 2017.

For the three months ended June 30, 2018, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, non-cash interest obligations under debt obligations, litigation related payments, and amortization of intangible assets, was $45.1 million, or $0.99 per share, compared to non-GAAP adjusted net loss of $57.0 million, or $1.31 per share, for the three months ended June 30, 2017.

For the three months ended June 30, 2018, TYMLOS net product revenues were $22.6 million compared to approximately $1.0 million for the three months ended June 30, 2017.

Radius made a $10.8 million payment to Ipsen in the second quarter pursuant to a final decision in arbitration proceedings with Ipsen, which is reflected in other operating expenses.

Research and development expense for the three months ended June 30, 2018, was $26.3 million compared to $19.7 million for the three months ended June 30, 2017, an increase of $6.7 million, or 34%. This increase was primarily driven by a $4.2 million increase in elacestrant project costs, a $1.4 million increase in abaloparatide-patch project costs, a $1.0 million increase in RAD140 project costs, a $0.4 million increase in abaloparatide-SC project costs, a $0.4 million increase in other project related expenses, and restructuring charges of $0.8 million related to the closure of the Company’s New Jersey office. These increases were partially offset by a $0.9 million decrease in personnel related spending.

For the three months ended June 30, 2018, selling, general and administrative expense was $48.6 million compared to $50.1 million for the three months ended June 30, 2017, a decrease of $1.5 million, or 3%. This decrease was primarily the result of decreases of $1.2 million and $0.8 million in compensation and travel related expenses. These decreases were partially offset by restructuring charges of $0.6 million related to the re-allocation of commercial resources.

Six Months Ended June 30, 2018

For the six months ended June 30, 2018, Radius reported a net loss of $130.4 million, or $2.89 per share, compared to a net loss of $125.4 million, or $2.90 per share, for the six months ended June 30, 2017.

For the six months ended June 30, 2018, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, non-cash interest obligations under debt obligations, litigation related payments, and amortization of intangible assets, was $95.6 million, or $2.12 per share, compared to non-GAAP adjusted net loss of $104.8 million, or $2.42 per share, for the six months ended June 30, 2017.

For the six months ended June 30, 2018, TYMLOS net product revenues were $37.2 million compared to approximately $1.0 million for the six months ended June 30, 2017.

Research and development expense for the six months ended June 30, 2018, was $49.2 million compared to $39.2 million for the six months ended June 30, 2017, an increase of $10.0 million, or 26%. This increase was primarily driven by a $4.8 million increase in elacestrant project costs, a $2.9 million increase in abaloparatide-SC project costs, a $1.5 million increase in abaloparatide-patch project costs, a $1.3 million increase in RAD140 project costs, and restructuring charges of $0.8 million related to the closure of the Company’s New Jersey office. These increases were partially offset by a $0.5 million decrease in other project related expenses.

Selling, general, and administrative expense for the six months ended June 30, 2018, was $96.6 million compared to $88.2 million for the six months ended June 30, 2017, an increase of $8.4 million, or 10%. This increase was primarily the result of increases of $5.4 million and $1.8 million in compensation and travel related expenses, respectively. These increases were partially offset by restructuring charges of $0.6 million related to the re-allocation of commercial resources.

As of June 30, 2018, Radius had $318.5 million in cash, cash equivalents, restricted cash, marketable securities and investments. Based upon our cash, cash equivalents, marketable securities and investments balance as of June 30, 2018, we believe that, prior to the consideration of proceeds from partnering and/or collaboration activities, we have sufficient capital to fund our development plans, U.S. commercial and other operational activities for not less than twelve months from the date of this press release.

In connection with today’s reporting of Second Quarter Financial Results, Radius will host a conference call and live audio webcast at 8:00 a.m. ET today, August 7, 2018, to discuss the commercial outlook for TYMLOS, review the financial results and provide a Company update.

Conference Call Information:
Date: Tuesday, August 7, 2018
Time: 8:00 a.m. ET
Domestic Dial-in Number: (866) 323-7965
International Dial-in Number: (346) 406-0961
Conference ID: 2768066
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available from August 7, 2018 at 11:00 a.m. ET and will be archived on the Company’s website for 90 days. To access the replay, dial (855) 859-2056 for U.S. or (404) 537-3406 for International, using conference ID number 2768066.

A live audio webcast of the call can be accessed from the Investors section of the Company’s website, www.radiuspharm.com. The full text of the announcement and financial results will also be available on the Company’s website.

Use of Non-GAAP Financial Measures
To supplement our condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (GAAP), we use the following non-GAAP financial measures: non-GAAP adjusted net loss and non-GAAP net loss per share. These non-GAAP financial measures exclude certain amounts or expenses from the corresponding financial measures determined in accordance with GAAP. Management believes this non-GAAP information is useful for investors, taken in conjunction with Radius’ GAAP financial statements, because it provides greater transparency regarding Radius’ operating performance. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Radius’ operating results as reported under GAAP, not in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures for the three and six months ended June 30, 2017 and 2018 are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

On August 7, 2018 Vical Incorporated (Nasdaq:VICL) reported financial results for the three months ended June 30, 2018 (Press release, Vical, AUG 7, 2018, View Source [SID1234528485]). Net loss for the second quarter of 2018 was $4.9 million, or $0.22 per share, compared with a net loss of $3.3 million, or $0.30 per share, for the second quarter of 2017. Revenues for the second quarter of 2018 were $0.7 million, compared with revenues of $3.4 million for the second quarter of 2017, reflecting a decline in revenues from Astellas Pharma Inc. for services performed under ASP0113 collaborative agreements.

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Vical recently announced plans to explore a range of strategic options to enhance shareholder value. The company retained MTS Health Partners, L.P. to assist in the strategic review process. There is no set timetable for the review process and there can be no assurance that the process will result in a transaction.

Vical had cash and investments of $54.3 million at June 30, 2018. The Company’s cash burn for the second quarter of 2018 was $4.0 million, which was consistent with the Company’s full year 2018 guidance of between $20 million and $24 million. The Company anticipates ending 2018 with a minimum of $40 million, which, in the absence of a strategic transaction, Vical believes to be sufficient to fund operations through the announcement of top-line data from its Phase 2 clinical trial of VL-2397, expected in 2020.

Program updates include:

VL-2397 Antifungal Candidate

The multinational Phase 2 registration trial comparing VL‑2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant is ongoing (ClinicalTrials.gov Identifier: NCT03327727). Vical expects to conduct the trial in approximately 40 major cancer and transplantation centers in North America, Europe and Asia. The FDA has advised that VL‑2397 would be eligible for a Limited Use Indication (LUI) approval for the treatment of invasive aspergillosis for patients with limited treatment options. The FDA has also granted Vical Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designations for VL‑2397 for the treatment of invasive aspergillosis. VL-2397 has a novel mechanism of antifungal action and could be the first therapeutic in a new class of antifungals.
VR-CHB01 Hepatitis B Virus (HBV) Therapeutic Candidate

The Company is pursuing preclinical development of a novel treatment for chronic HBV infection based on its DNA and lipid-delivery technologies. The initial aim of this program will be to demonstrate proof of concept for inhibiting HBV infection in an in vivo model. The Company expects to complete the initial stage of preclinical development in the fourth quarter of 2018.

On August 7, 2018 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results for the second quarter ended June 30, 2018. In addition, the Company provided a clinical and business update (Press release, Syndax, AUG 7, 2018, View Source [SID1234528501]). As of June 30, 2018, Syndax had $98.4 million in cash, cash equivalents and short-term investments.

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"We made great progress across multiple programs during the first half of this year, including presentation of data from all three cohorts of ENCORE 601 and completion of target enrollment in ENCORE 602 and 603. We also initiated the first combination trial for the SNDX-6352 program, which will evaluate its safety in combination with durvalumab (IMFINZI)," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "We continue to expect the progression free survival results from E2112, our ongoing Phase 3 trial of entinostat plus exemestane in HR+, HER2- breast cancer, later this quarter, and the third prespecified interim analysis of overall survival in November. We also anticipate sharing next steps for the entinostat-KEYTRUDA (pembrolizumab) combination program in both non-small cell lung cancer and melanoma by the end of the year."

The Company also announced today that it plans to initiate a Phase 1 trial of its monoclonal antibody inhibitor of Colony-Stimulating Factor 1 Receptor (CSF-1R), SNDX-6352, in patients with chronic graft versus host disease (cGVHD). Enrollment in this trial is anticipated to begin by the end of the year, with initial data expected in the second half of 2019.

"We are excited to begin the evaluation of SNDX-6352 as a treatment for cGVHD, a novel clinical path for a CSF1-R inhibitor," said Michael L. Meyers, M.D., Ph.D., Chief Medical Officer of Syndax. "Preclinical findings support that CSF-1R inhibition may serve as an effective approach for treating this debilitating, often deadly side effect of allogenic hematopoietic stem cell transplantation. We look forward to learning more about the potential of SNDX-6352 in this indication."

Pipeline Updates

The Phase 3 registration trial of entinostat plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer, E2112, is 98% enrolled as of the end of July. ECOG-ACRIN Cancer Research Group, the trial sponsor, had notified the Company that the Data Safety Monitoring Committee (DSMC) completed the final progression free survival (PFS) analysis in November 2017. The trial is proceeding as planned, and Syndax continues to anticipate that enrollment will be complete in the third quarter of 2018, at which time the result of the PFS analysis will be released to the Company. In addition, interim overall survival (OS) analyses are scheduled to occur every May and November. Two interim OS analyses have already occurred, with the next analysis expected this November.

The Company presented data from a subset of PD-(L)1 refractory non-small cell lung cancer (NSCLC) patients enrolled in the expanded Phase 2 ENCORE 601 cohort (n = 57) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June. Updated data from all patients (n = 76) enrolled in this cohort will be presented at the World Conference on Lung Cancer Meeting in Toronto next month, including updated results from the Company’s biomarker analyses. The Company expects to communicate its development plans for entinostat in this indication in the fourth quarter.

The Company presented data from a subset of PD-1 refractory melanoma patients enrolled in the expanded Phase 2 ENCORE 601 cohort (n = 34) at the ASCO (Free ASCO Whitepaper) Annual Meeting in June. Updated results from the full cohort (n = 55) are expected by the end of this year, at which time the Company will make a decision on registration plans for entinostat in this indication.

Enrollment in the expanded stage 1 ENCORE 601 cohort of patients with microsatellite stable colorectal cancer (MSS-CRC, n = 37) is expected to complete in the third quarter. A decision on whether to continue to the second stage of this cohort is expected in the first half of 2019.

Target enrollment in both the Phase 2 portion of ENCORE 602, the Phase 1b/2 clinical trial evaluating the combination of entinostat plus Genentech’s PD-L1 inhibitor, atezolizumab (TECENTRIQ), in patients with triple negative breast cancer, and the Phase 2 portion of ENCORE 603, evaluating entinostat in combination with Pfizer/Merck KGaA’s PD-L1 inhibitor, avelumab (BAVENCIO), in patients with ovarian cancer, is complete. Topline results from each study are anticipated in the first half of 2019.

ENCORE 606, the Phase 1b/2 trial evaluating entinostat in combination with NKTR-214, Nektar’s CD122-biased agonist, is expected to begin enrolling patients in the first half of 2019.

Dosing of patients with solid tumors in the Phase 1/1b trial evaluating the safety of SNDX-6352 continues as planned. Testing of SNDX-6352 in combination with durvalumab (IMFINZI), AstraZeneca’s human monoclonal antibody directed against PD-L1, was recently initiated, and dosing of patients with SNDX-6352 as a monotherapy is ongoing. The Company anticipates identifying the recommended Phase 2 dose and schedule for SNDX-6352 monotherapy and in combination with durvalumab in the first half of 2019.

The Company expects to commence enrollment in a Phase 1 dose escalation trial of SNDX-6352 in patients with cGVHD by the end of the year. The objectives of this trial are to evaluate the safety and preliminary efficacy of SNDX-6352 in cGVHD and to identify a recommended Phase 2 dose and schedule. Initial results are anticipated in the second half of 2019.

Development of the Company’s portfolio of Menin-Mixed Lineage Leukemia (MLLr) inhibitors is ongoing. The Company continues to expect clinical trials to initiate in the first half of 2019.
Second Quarter 2018 Financial Results

As of June 30, 2018, Syndax had cash, cash equivalents and short-term investments of $98.4 million and 22,705,794 shares issued and outstanding.

On June 18, 2018, the Company signed an exchange agreement with Biotechnology Value Fund and certain affiliated funds ("BVF") under which BVF exchanged 2,000,000 shares of common stock for 2,000,000 Warrant Shares. BVF can exercise the Warrant Shares at an exercise price per share equal to $0.0001 per share. The warrant is issued for a period of 20 years.

In the third quarter of 2018, through August 6th, the Company sold 633,231 shares of its common stock with net proceeds of approximately $4.4 million pursuant to its at-the-market arrangement.

Second quarter 2018 research and development expenses increased to $14.9 million from $9.9 million for the comparable period in the prior year. The increases were primarily due to increased activities in manufacturing for SNDX-6352, increased development activities for the Menin-MLLr and ENCORE 602 programs partially offset by completion of pharmacology trials and lower program cost for E2112. Employee compensation increased due to increased headcount.

General and administrative expenses totaled $4.5 million during the second quarter of 2018, compared to $4.3 million for the comparable period in the prior year. The increase in general and administrative expenses was primarily due to increased pre-commercialization activities and increased patent related legal expenses.

For the three months ended June 30, 2018, Syndax reported a net loss attributable to common stockholders of $18.4 million or $0.74 per share compared to $13.6 million or $0.70 per share for the comparable prior year period.

Financial Guidance

Today the Company provided operating expense guidance for the third quarter and full year 2018. For the third quarter and full year 2018, research and development expenses are expected to be $14 to $16 million and $59 to $62 million, respectively, and total operating expenses are expected to be $18 to $20 million and $77 to $81 million, respectively. Total operating expenses for 2018 are expected to include approximately $6 million of non-cash stock compensation expense.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Tuesday, August 7, 2018.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 4980058
Domestic Dial-in Number: 1- 855-251-6663
International Dial-in Number: 281-542-4259
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.

On August 7, 2018 Protagonist Therapeutics, Inc. (Nasdaq:PTGX) reported its financial results for the second quarter ended June 30, 2018 (Press release, Protagonist, AUG 7, 2018, View Source;p=RssLanding&cat=news&id=2362550 [SID1234528527]).

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"Protagonist continues to advance well-differentiated therapeutic candidates discovered through its novel peptide technology platform," commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "We very recently reported results from a comprehensive review of the data from the Phase 2 PROPEL study of PTG-100 for the treatment of moderate to severe active ulcerative colitis. We are pleased to conclude that this drug candidate showed signals of clinical efficacy, has no safety concerns, and warrants further clinical development for potential treatment of ulcerative colitis. We are planning to discuss next steps in the clinical development of PTG-100 with the U.S. Food and Drug Administration (FDA) and other global regulatory authorities in the second half of this year. We are glad to report on the continued progress of the clinical development of PTG-200 in collaboration with our partner Janssen for potential treatment of Crohn’s disease. In addition, we look forward to initiating an open label Phase 2 study in beta-thalassemia patients in the fourth quarter of 2018 with PTG-300, our product candidate for rare blood disorders."

Product Development Update:

PTG-100

In March 2018, Protagonist had announced discontinuation of the Phase 2 PROPEL study following a planned interim analysis conducted by an independent Data Monitoring Committee. The interim data had revealed an unusually high placebo rate of clinical remission (24 percent, approximately four times higher than historical norms for similar UC studies) that led to a futility decision and discontinuation of the trial. A re-read of the endoscopies by the subcontractor of the contract research organization (CRO) and a subsequent fully blinded re-read of the endoscopies by an independent third party, Robarts Clinical Trials, confirmed that a subset of the initial endoscopy reads provided by the CRO were in error. If the re-read of endoscopy results had been utilized for the interim futility analysis, the trial would have continued. Based on this entire analysis, the Company plans to discuss the next steps in advancing the clinical development of PTG-100 with the FDA and other global regulatory authorities in the second half of 2018.
PTG-200

In the fourth quarter of 2018, Protagonist expects a U.S. IND filing by its partner Janssen Biotech that will support the initiation of a global Phase 2 study of PTG-200, an oral, gut-restricted interleukin-23 receptor antagonist peptide in Crohn’s disease patients. This IND filing would trigger a milestone payment from Janssen of $25 million under the existing exclusive license and collaboration agreement between Janssen and Protagonist.
PTG-300

The results of a Phase 1 study in healthy volunteers and supportive pre-clinical data for PTG-300, an injectable hepcidin mimetic peptide, were the subject of oral presentations in June 2018 at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper).
Protagonist completed discussions with U.S. and global regulatory agencies and filed a U.S. IND in the second quarter of 2018. The Company plans other global regulatory submissions to support the initiation of a global Phase 2 trial in patients with beta-thalassemia in the fourth quarter of 2018.
Preclinical Programs

The Company presented data related to preclinical product candidates, oral peptide agonists targeting the delta/mu opioid receptors, in a podium presentation at the Digestive Diseases Week conference in June 2018.
Corporate Update – Financing:

Protagonist recently announced the completion of an equity financing with investors including BVF Partners L.P. and their affiliates for gross proceeds of $22 million. Proceeds from the financing will be used to advance development of drug candidate PTG-100.
Financial Results

Protagonist reported a net loss of $8.7 million and $16.3 million, respectively, for the second quarter and first six months of 2018, as compared to a net loss of $15.0 million and $29.1 million, respectively, for the same periods of 2017. The decrease in net loss for both the second quarter and year-to-date periods was driven primarily by license and collaboration revenue recognized during the first and second quarters of 2018, partially offset by increased research and development (R&D) and general and administrative (G&A) expenses. The net loss for the second quarter and first six months of 2018 includes non-cash stock-based compensation of $1.6 million and $2.8 million, respectively, as compared to $1.0 million and $1.8 million, respectively, for the same periods of 2017.

License and collaboration revenue was $11.7 million and $22.5 million for the second quarter and first six months of 2018, respectively, and consisted of revenue from activities performed under the Janssen Collaboration Agreement. Protagonist did not recognize any license and collaboration revenue for the second quarter or first six months of 2017.

R&D expenses for the second quarter and first six months of 2018 were $17.7 million and $33.1 million, respectively, as compared to $12.0 million and $23.3 million, respectively, for the same periods of 2017. The increases in R&D expenses were primarily due to costs related to contract manufacturing and the preparation for and conduct of clinical trials for our product candidates. R&D expenses for the quarter also included an increase in salaries and employee-related expenses due to an increase in R&D personnel.

G&A expenses for the second quarter and first six months of 2018 were $3.2 million and $6.8 million, respectively, as compared to $3.1 million and $6.1 million, respectively, for the same periods of 2017. The increases in G&A expenses were primarily due to increases in salaries and employee-related expenses primarily due to an increase in headcount to support the growth of our operations, partially offset by a decrease in legal expenses.

Protagonist ended the second quarter with $125.2 million in cash, cash equivalents and investments. With the financing announced yesterday, the company expects to have sufficient financial resources to fund operations to mid-2020.

On August 7, 2018 Stony Brook University, iCell Gene Therapeutics, and the University of Louisville, have received Food and Drug Administration (FDA) clearance for an Investigational New Drug (IND) for the treatment of relapsed and refractory T-cell leukemia and lymphoma (Press release, Stony Brook University, AUG 7, 2018, View Source [SID1234528670]). The approach is the first to use chimeric antigen receptor engineered T-cells directed against the target protein CD4 (CD4CAR). Together, Stony Brook University, the University of Louisville, and iCell Gene Therapeutics expect the first in-human Phase I clinical trial to begin accruing patients before the end of 2018.

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"We are excited to partner with the University of Louisville and iCell Gene Therapeutics to offer this innovative first-in-human CAR T cell immunotherapy clinical trial for patients who are suffering from these extremely difficult to treat T cell lymphomas and leukemias," said Huda Salman, MD, Principal Investigator for the IND and an oncologist at Stony Brook University Cancer Center. "CD4CAR T cells may prove to be a promising and novel therapy in this setting."

"The development of this trial using CD4 as a target is the first of what we expect to be many CAR T-based clinical trials available to our patients over time," said Yusuf Hannun, MD, Director of the Stony Brook University Cancer Center. "The pending trial is an example of the type of bench-to-bedside research that is building up at Stony Brook due to the growing expertise and collaborative research environment we are creating and new opportunities that will emerge upon the opening of our Medical and Research Translation (MART) Building."

William Tse, MD, FACP, Chief of the Blood and Marrow Transplantation at the University of Louisville School of Medicine, is the Co-PI of the CD4CAR clinical trial at University of Louisville site.

About CD4CAR

CD4CAR is a novel development for the treatment of CD4+ T-cell malignancies. The CD4-redirected chimeric antigen receptor (CAR) T-cells are engineered to express an anti-CD4scFV antibody domain. CD4CAR has received Orphan Drug Designation by the FDA for Peripheral T cell Leukemia (PTCL) in 2016. Over the past few years, CAR T-cell therapy has proven its efficacy in clinical trials for various types of leukemia, lymphoma, and myeloma. CAR T-cell therapy is a type of adoptive immunotherapy. A CAR-engineered T-cell is genetically modified to express a protein on its surface with the capability to bind to a target protein on another cell. The CD4CAR is manufactured from the patient’s own cells to target CD4 expressed on tumor cells. Once these cells are infused back into a patient’s body through an IV, they multiply and attack tumor cells efficiently throughout the body.

About T-cell leukemias and lymphomas

Although there are clinical development programs ongoing with CAR T-cells for B-cell hematological malignancies, CD4 positive T-cell malignancies (T-cell lymphomas (TCLs) and T–cell acute lymphoblastic leukemia (T-ALLs)), have not been targeted by a CAR therapy in a human trial. TCLs account for 15–20 % of all non-Hodgkin’s lymphomas (NHLs), while T-ALLs affect about 25% of ALLs in adults. These malignant entities are significantly more difficult to treat in comparison to B-cell malignancies. Furthermore, T-cell malignancies almost exclusively have poorer outcomes with few exceptions, lower response rates, shorter times of disease control and survival. As a result, the standard of care for T-cell malignancies is not well-established and the only potential curative approach is allogeneic blood and marrow transplant (BMT) for which patients need to achieve complete disease control and to have suitable marrow donors. This leaves many patients with no curative options.