On August 7, 2018 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported record financial results for the second quarter of 2018 and related Company developments (Press release, Supernus, AUG 7, 2018, View Source [SID1234528934]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Progress of Product Pipeline

SPN-812 — Novel non-stimulant for the treatment of ADHD

·The program consists of four three-arm, placebo-controlled trials: P301 and P302 trials in patients 6-11 years old, and P303 and P304 trials in adolescent patients.

·Enrollment is complete in the P301 trial, with data expected in the fourth quarter of 2018.

The remaining three trials are at approximately 89% enrollment, with data expected in the first quarter of 2019.

·Roll-over from the four Phase III trials to the open label extension study is approximately 90%.

SPN-810 — Treatment of Impulsive Aggression in patients with ADHD

· Enrollment in the Phase III pediatric trials, P301 and P302, is approximately 91% and 77%, respectively.

· The Company anticipates having data from P301 by the first quarter of 2019 and data from P302 by mid-2019.

· Roll-over from the two Phase III trials to the open label extension study continues at approximately 90%.

·Patient screening has been initiated in the Phase III trial treating adolescents.

Oxtellar XR —Treatment of Bipolar Disorder

The Company is planning to initiate pivotal Phase III studies for treatment of bipolar disorder in the second half of 2019.

"As we enter the second half of 2018, we remain focused on the successful completion of our clinical programs and look forward to providing top-line data from the first Phase III trial for SPN-812 in the fourth quarter of 2018," said Jack Khattar.

Operating Expenses

Research and development expenses in the second quarter of 2018 were $20.0 million, as compared to $10.8 million in the same quarter last year. The increase was due primarily to the initiation of the four Phase III clinical trials for SPN-812 in the second half of 2017 and to a lesser extent, the open-label extension trials for SPN-812 and SPN-810.

Selling, general and administrative expenses in the second quarter of 2018 were $40.1 million, as compared to $35.1 million in the same quarter last year. The increase was due to the expansion of the salesforce by 40 salespeople, which were fully deployed in the fourth quarter of 2017; marketing programs to support the Company’s commercial products; and an increase in share-based compensation.

Operating Earnings and Earnings Per Share

Operating earnings in the second quarter of 2018 were $35.7 million, a 37.0% increase over $26.1 million in the same period the prior year. The improvement in operating earnings was primarily due to increased net product sales, partially offset by increased operating expenses.

GAAP net earnings in the second quarter of 2018 were $30.7 million, as compared to $17.4 million in the same period last year. In addition to higher operating income, GAAP net earnings for the second quarter of 2018 benefited from the reduction in the statutory U.S. federal income tax rate and from stock option exercises.

GAAP diluted earnings per share (EPS) were $0.57 in the second quarter of 2018, compared to $0.32 in the second quarter of 2017. Net interest expense and non-cash deferred financing costs associated with the sale of $402.5 million of convertible senior notes in March 2018 had the effect of reducing GAAP net earnings by approximately $4.3 million, or $0.08 per diluted share, in the second quarter of 2018.

Weighted-average diluted common shares outstanding were approximately 54.2 million in the second quarter of 2018, as compared to approximately 53.2 million in the second quarter of 2017.

As of June 30, 2018, the Company had $677.7 million in cash, cash equivalents, marketable securities and long term marketable securities, as compared to $273.7 million at December 31, 2017. This increase reflects net proceeds of $364.9 million from the issuance of convertible senior notes and warrants, partially offset by purchases of convertible note hedges in March 2018, as well as increased cash from operations in the six months ended June 30, 2018.

Financial Guidance

For full year 2018, the Company is updating its prior guidance as set forth below:

Net product sales in the range of $385 million to $400 million, compared to the previously expected range of $375 million to $400 million.

·Research and development expenses of approximately $80 million.

·Operating earnings in the range of $130 million to $140 million, compared to the previously expected range of $125 million to $135 million. The Company continues to expect approximately $7 million of licensing and non-cash royalty revenue.

· The Company expects an effective tax rate of approximately 23% to 25% for the third and fourth quarters of 2018.

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, August 8, 2018. An accompanying webcast also will be provided.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in:

(877) 288-1043

International dial-in:

(970) 315-0267

Conference ID:

7484048

Conference Call Name:

Supernus Pharmaceuticals Second Quarter 2018 Earnings Conference Call

On August 7, 2018 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on our Probody therapeutic technology platform, reported that it will present at the 2018 Wedbush PacGrow Healthcare Conference. Debanjan Ray, chief financial officer, will present a corporate overview on August 14, 2018, at 9:45 a.m. ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live audio webcast of the presentation will be available through the Investors and News section of CytomX’s website. An archived replay will be available for 90 days following the event.

On August 7, 2018 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage pharmaceutical company focused on discovering and developing small molecule drugs that target novel and critical metabolic pathways in tumor and cancer-fighting immune cells, reported its financial results for the second quarter ended June 30, 2018 (Press release, Calithera Biosciences, AUG 7, 2018, View Source [SID1234528513]). As of June 30, 2018, cash, cash equivalents and investments totaled $152.2 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the second quarter we continued to execute our clinical development plans for our glutaminase inhibitor and arginase inhibitor programs, while deepening our pipeline with two novel programs entering clinical development," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We have advanced CB-280, a novel arginase inhibitor into development for the treatment of cystic fibrosis and we announced today our next oncometabolism drug candidate, CB-708, an orally bioavailable small molecule CD73 inhibitor."

Second Quarter 2018 and Recent Highlights

Enrolling Two Randomized Phase 2 Combination Trials of CB-839 in Combination for the Treatment of Renal Cell Carcinoma. The ENTRATA trial, a randomized double-blind placebo-controlled study of late line patients, is enrolling approximately 66 patients to receive either everolimus and CB-839 or everolimus alone. It is now expected to enroll by the fourth quarter of 2018, or early 2019. CANTATA is a randomized double-blind placebo-controlled trial comparing advanced patients treated with cabozantinib and CB-839 to patients treated with cabozantinib alone. This trial will enroll approximately 300 clear cell renal cell carcinoma patients who have previously received one or two prior lines of therapy. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CB-839 in combination with cabozantinib for the treatment of this patient population. The trial opened in 2018 and is expected to take approximately two years to reach the primary endpoint analysis.

Presented Results of CB-839 in Combination with Capecitabine at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). A Phase 1 Investigator sponsored clinical trial of CB-839 plus capecitabine was presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).1 In patients with late-line colorectal cancer that had progressed on at least one prior fluoropyrimidine-containing regimen, the median PFS was 26 weeks for patients with PIK3CA mutated cancer (n=7) and 16 weeks for patients with PIK3CA wild-type cancer (n=5,p=0.058). The Phase 2 portion of this study in patients with PIK3CA mutant colorectal cancer is ongoing.

Evaluating CB-839 in Combination with Paclitaxel in Triple Negative Breast Cancer (TNBC). A Phase 2 trial evaluating CB-839 with paclitaxel in TNBC patients is ongoing. Four single arm, open label, cohorts of African American and non-African American patients are being treated in both the early and late stage settings. The primary endpoint of this trial is objective response rate and a number of predictive biomarkers are being assessed. Based on our preliminary Phase 2 clinical trial results and recent changes in the competitive landscape of TNBC, we do not plan to pursue further development of CB-839 plus paclitaxel in TNBC at this time.

Enrolling INCB001158 Clinical Trials. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with solid tumors both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with Incyte.

Advanced Arginase Inhibitor CB-280 for the Treatment of Cystic Fibrosis. Arginase has been proposed to be critical in the pathology of cystic fibrosis by impairing production of nitric oxide. CB-280 is an orally administered small molecule inhibitor of arginase. An investigational new drug (IND) application for CB-280 with the U.S. FDA is planned for the first half of 2019.

Selected CD73 Small Molecule Inhibitor to Enter Clinical Development in 2019. The enzyme CD73 is an oncometabolism target that plays a critical role in the process of ATP conversion to adenosine. An IND application for CB-708, an orally administered small molecule inhibitor of CD73, is planned in 2019.

R&D Day Planned on October 5, 2018 in New York City. The meeting will focus on the Company’s research and development programs, including CB-280 and CB-708. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website.

Selected Second Quarter 2018 Financial Results

Cash, cash equivalents and investments totaled $152.2 million at June 30, 2018.

Revenue was $17.1 million for the three months ended June 30, 2018, compared with $7.3 million for the same period in the prior year. In the second quarter of 2018, the Company completed the manufacturing services and technology transfer under its collaboration and license agreement with Incyte, which satisfied the performance obligation under ASC 606 and as a result all remaining deferred revenue was recognized.

Research and development expenses were $17.3 million for the three months ended June 30, 2018, compared with $10.1 million for the same period in the prior year. The increase of $7.2 million was due to an increase in the CB-839 program, including for the Phase 2 CANTATA trial which opened in 2018, an increase in the INCB001158 program, including Incyte’s co-funding of development costs, an increase in the CB-280 program, including to support the IND application, as well as investment in early stage research.

General and administrative expenses were $3.5 million for the three months ended June 30, 2018, compared with $2.8 million for the same period in the prior year. The increase of $0.7 million was primarily due to increases in personnel-related costs.

Net loss from operations for the three months ended June 30, 2018 was $3.1 million, or $0.09 per share.

Conference Call Information

Calithera will host an update conference call today, August 7th at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time. The call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international), and referring to conference ID 2057667. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On August 7, 2018 Teneobio, Inc., a next generation multi-specific antibody therapeutics company, and Poseida Therapeutics, Inc., a San Diego-based clinical-stage company translating best-in-class gene engineering technologies into lifesaving cell therapies, reported a new research collaboration and licensing agreement to develop novel CAR-T therapies using Teneobio’s heavy chain only domain antibodies (UniDabs) (Press release, TeneoBio, AUG 7, 2018, View Source [SID1234558319]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Poseida will apply UniDab binders, which demonstrate significant advantages over traditional single chain variable antibody fragment (scFv) binders, to the development of its next generation CAR-T therapies.

The new collaboration follows a commercial license agreement between the companies that was announced in May of 2017. Under the terms of the new agreement, Teneobio will generate multiple UniDab product candidates using its proprietary UniRat transgenic human antibody ‘heavy-chain only’ rodent platform and its state-of-the-art sequence-based discovery engine, TeneoSeek. Poseida will have exclusive global licensing rights for the clinical development and commercialization of specific UniDabs for CAR-T therapies.

Teneobio Inc. will receive an upfront payment and is eligible to receive future research, development and regulatory milestone payments per UniDab candidate, with total potential earnings of over $250 million for CAR-T therapies developed by Poseida. Teneobio would also receive royalties on worldwide net sales of each CAR-T therapy.

"We are delighted to partner with Poseida and to help create the next generation of cell therapies," said Roland Buelow, CEO of Teneobio. "Domain antibodies have been clinically validated as excellent targeting moieties in CAR-T cells. They confer robust in vivo specificity and efficacy. They are smaller in size, have greater humanicity, and superior developability relative to standard scFv’s. The use of UniDabs as binders in CAR-T products is predicted to result in a lack of tonic signaling and lower immunogenicity, thus solving some of the problems of the first-generation, scFv-based CAR-T therapies."

Eric Ostertag, CEO of Poseida, noted, "Teneobio’s UniDab binders are an ideal match for Poseida’s novel and industry-leading CAR-T platform technologies. Poseida has demonstrated that UniDabs can be engineered to serve as binding molecules for our CAR-T therapeutics and oftentimes may function better than other binders for use in CAR-T products."

"We are pleased to expand our existing partnership with Poseida, whose cutting-edge genetic engineering tools combined with our targeting UniDab candidates will enable the development of the next generation of superior CAR-T therapies to treat cancer. We believe that UniDabs provide differentiated advantages from other targeting moieties, and that their utility and reach will extend beyond antibody therapeutics to novel transformational cell therapy treatments," added Omid Vafa, CBO of Teneobio.

On August 7, 2018 Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX), a clinical stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin (TTR) amyloidosis (ATTR), reported its financial results for the quarter ended June 30, 2018 and provided an update on the Company’s recent achievements (Press release, Eidos Therapeutics, AUG 7, 2018, View Source [SID1234576275]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With the proceeds from our IPO and Series B financing, we are well positioned to continue the momentum of developing AG10 as a disease-modifying therapy for ATTR," said Neil Kumar, PhD, chief executive officer of Eidos. "Specifically, we plan to complete our ongoing Phase 2 trial in ATTR-CM patients by the end of 2018 and initiate Phase 3 studies in ATTR-CM and ATTR-PN patients in 2019."

Recent Achievements and Upcoming Milestones

Initiated and completed enrollment in the ongoing Phase 2 trial in ATTR-CM patients.
Completed Series B preferred stock financing raising $64 million.
Completed initial public offering, with total gross proceeds of $122.2 million including exercise of underwriters’ option to purchase additional shares, from the sale of 7.2 million shares of common stock.
Complete data from Phase 1 study of AG10 in healthy volunteers to be presented at poster presentation at Heart Failure Society of America 22nd Annual Scientific Meeting (September 15-18).
Top-line results from ongoing Phase 2 study of AG10 in symptomatic ATTR-CM patients to be announced by the end of 2018.
Financial Results for the Second Quarter 2018

Cash and cash equivalents totaled $176.7 million at June 30, 2018 compared with $5.5 million at December 31, 2017, reflecting the $112.2 million of net proceeds from our initial public offering in June 2018 and $64.0 million related to the Series B preferred stock financing.

Research and development expenses were $7.4 million for the second quarter of 2018, compared to $1.3 million for the same period of 2017, an increase of $6.1 million. The increase was primarily due to increased expenses for contract consultants, contract manufacturing and other activities for AG10 clinical trials and increases in headcount and related salaries and expenses.

General and administrative expenses were $1.9 million for the second quarter of 2018 compared to $0.5 million for the same period in 2017, an increase of $1.4 million. The increase was primarily due to increased salaries and employee-related expenses and increases in professional fees and services in connection with becoming a public company.

Net loss for the quarter ended June 30, 2018 was $10.6 million or $1.38 per common share, compared to a net loss of $1.7 million or $0.49 per common share for the same period in 2017.

About AG10

AG10 is an orally-administered small molecule designed to potently stabilize tetrameric transthyretin, or TTR, thereby halting at its outset the series of molecular events that give rise to amyloidosis, or ATTR. AG10 is currently being examined in a Phase 2 clinical trial in patients with ATTR cardiomyopathy. Top-line results from this trial are expected to be reported by the end of 2018.

AG10 was designed to mimic a naturally-occurring variant of the TTR gene (T119M) that is considered a "rescue mutation" because it has been shown to prevent ATTR in individuals carrying pathogenic, or disease-causing, mutations in the TTR gene. To our knowledge, AG10 is the only TTR stabilizer in development that has been observed to mimic the "super-stabilizing" properties of this rescue mutation.