On February 26, 2019 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported record financial results for the fourth quarter and full year 2018 and associated Company developments (Press release, Supernus, FEB 26, 2019, View Source [SID1234533734]).

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Commercial Update

Fourth quarter 2018 product prescriptions for Trokendi XR and Oxtellar XR, as reported by IQVIA, totaled 209,901, a 16.7% increase over the fourth quarter of 2017. Full year 2018 product prescriptions for Trokendi XR and Oxtellar XR, as reported by IQVIA, totaled 786,411, a 29.1% increase over full year 2017.

"We reported another year of strong operating results in 2018, driven by continued double-digit prescription growth for both Trokendi XR and Oxtellar XR," said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "In addition, we recently reached a key milestone by launching Oxtellar XR, in January 2019, with an expanded indication to include monotherapy for partial seizures, which could be a meaningful long term growth opportunity."

Progress of Product Pipeline

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

· During December 2018, the Company announced positive topline results from the two pediatric Phase III trials (P301 and P303) and from the first adolescent Phase III trial (P302). All three trials met the primary endpoint with robust statistical significance. Topline data from the second and final adolescent Phase III trial (P304) are expected by the end of the first quarter of 2019.

· The Company continues to expect to submit a New Drug Application (NDA) for SPN-812 in the second half of 2019, and to launch it, pending U.S. Food and Drug Administration (FDA) approval, in the second half of 2020.

·A Phase III program in adult patients is anticipated to start in the second half of 2019.

SPN-810 — Novel treatment of Impulsive Aggression in patients with ADHD

· Enrollment in the Phase III trials (P301 and P302) continues with data from both trials expected in the second half of 2019.

· The Company continues to expect to submit an NDA for SPN-810 in the second half of 2020, and to launch it, pending FDA approval, in the second half of 2021.

· Enrollment in the Open Label Extension (OLE) study continues at 90% or higher. On average, a patient in the OLE study remains on SPN-810 treatment for approximately 10 months, which we believe is an encouraging sign of the tolerability and efficacy of SPN-810.

· Patient dosing continues in the Phase III trial (P503) in adolescent patients.

SPN-604 — Novel treatment of bipolar disorder

· The Company expects to start pivotal Phase III studies for the treatment of bipolar disorder in the second half of 2019.

"We made significant progress in 2018 advancing our late-stage programs through clinical development, including announcing positive topline results from three Phase III trials for SPN-812 for treatment of ADHD," said Jack Khattar. "We are focused in 2019 on submitting the NDA for SPN-812 and completing the Phase III trials for SPN-810, moving us closer to our goal of

delivering, in the next several years, two novel products, both addressing billion-dollar market opportunities. In addition, we look forward to starting another Phase III program this year, with SPN-604 for the treatment of bipolar disorder."

Operating Expenses

Fourth Quarter

Research and development expenses in the fourth quarter of 2018 were $29.8 million, as compared to $16.2 million in the same quarter last year. This increase was primarily due to the one-time upfront expense of approximately $14 million in the fourth quarter of 2018 for the acquisition of Biscayne Neurotherapeutics, Inc. (Biscayne).

Selling, general and administrative expenses in the fourth quarter of 2018 were $42.1 million, as compared to $33.8 million in the same quarter last year. This increase was primarily due to the development and production of promotional materials and marketing programs associated with the launch of the monotherapy indication for Oxtellar XR, and an increase in share-based compensation expense.

Full Year

Research and development expenses for the full year 2018 were $89.2 million, as compared to $49.6 million for 2017. This increase was primarily due to the initiation of the four Phase III clinical trials for SPN-812 in the second half of 2017, the OLE trials for SPN-812 and SPN-810, and the one-time upfront expense of approximately $14 million for the acquisition of Biscayne.

Selling, general and administrative expenses for full year 2018 were $159.9 million, as compared to $137.9 million in 2017. This increase was primarily due to the expansion of the salesforce by 40 salespeople, who were fully deployed in the fourth quarter of 2017, increased marketing spend to support Trokendi XR, as well as the factors impacting the fourth quarter as described above.

Operating Earnings and Earnings Per Share

Operating earnings in the fourth quarter of 2018 were $39.9 million, a 16% increase over $34.3 million in the same period the prior year. Operating earnings in full year 2018 were $144.4 million, a 45.1% increase over $99.5 million in 2017. The improvement in operating earnings in both periods was primarily due to increased net product sales, offset by the aforementioned one-time upfront expense of approximately $14 million for the acquisition of Biscayne.

Net earnings (GAAP) in the fourth quarter of 2018 were $25.9 million, or $0.48 per diluted share, an increase of 85% on diluted share amount, as compared to $13.7 million, or $0.26 per diluted share, in the same period last year. Net earnings (GAAP) were $111.0 million in 2018, or $2.05 per diluted share, an increase of 90% on diluted share amount, as compared to $57.3 million, or $1.08 per diluted share, in 2017. In addition to higher operating income for the fourth quarter and full year 2018, net earnings (GAAP) benefited from the reduction in the statutory U.S. Federal income tax rate and, to a lesser extent, from stock option exercises. The reduction in income tax rate had an unfavorable impact of $9.7 million in both the fourth quarter and full year 2017.

Weighted-average diluted common shares outstanding were approximately 54.1 million in the fourth quarter and full year 2018, as compared to approximately 53.5 million and 53.3 million in each of the respective prior year periods.

Balance Sheet Highlights

As of December 31, 2018, the Company had $774.8 million in cash, cash equivalents, marketable securities, and long term marketable securities, 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 in March 2018, partially offset by purchases of convertible note hedges, the aforementioned one-time upfront payment of $15 million for the acquisition of Biscayne, and increased cash from operations in 2018.

Financial Guidance

For full year 2019, the Company estimates net product sales, research and development expenses, operating earnings, and an effective tax rate as set forth below. This guidance assumes that the short-term higher levels of wholesaler and pharmacy channel inventory experienced in the fourth quarter of 2018 will revert to historical levels in 2019.

· Net product sales in the range of $435 million to $455 million. Guidance reflects the Company’s expectation that wholesaler and pharmacy channel inventory levels will revert to historical 2018 levels, thereby affecting 2019 net product sales by approximately $10 million.

· Research and development expenses in the range of $70 million to $80 million.

· Operating earnings in the range of $160 million to $180 million.

· Effective tax rate of approximately 23% to 25%.

Investor Day

The Company is pleased to announce that it will hold an Investor Day in New York City on April 16, 2019. The management team plans to provide an overview of the Company including a detailed discussion on its clinical programs and an assessment of the associated market opportunities.

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Senior Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, February 27, 2019. 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:

2170478

Conference Call Name:

Supernus Pharmaceuticals Fourth Quarter and Full Year 2018 Earnings Conference Call

Following the live call, a replay will be available on the Company’s website, www.supernus.com, under "Investor Relations".

On February 26, 2019 Gracell Biotechnologies, Co., Ltd. ("Gracell") reported the completion of its $85 million series B funding today (Press release, Gracell Biotechnologies, FEB 26, 2019, View Source [SID1234539454]). The financing was led by Temasek with Lilly Asia Ventures, Kington Capital, King Star Capital and Chengdu Miaoji also participated in the round. This new funding will enable Gracell to enter clinical trials with several of its next generation immune cell gene therapy candidates.

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Founded by Dr. Wei (William) Cao in 2017, Gracell is an innovative biomedical company focusing on the development of next generation immune cell gene therapies. Dr. Cao was previously co-founder and CEO of a Nasdaq-listed cell therapy company. Gracell was initially supported by series A financing from 6 Dimensions shortly after its establishment.

Gracell says it is committed to developing high-quality, low-cost cellular gene therapies and solving many of the technical difficulties in the cellular gene therapy field, including complex manufacture, lack of off-the-shelf products, and short duration efficacy. To implement its vision, Gracell believes it has gathered one of the top teams in the industry from China and the U.S.

To date, Gracell has completed pre-clinical development of a series of low-cost CAR-T products and entered clinical research through Institutional Review Board (IRB) studies. Other products under development include CAR-T cell products developed on the company’s FasT(TM) CAR technology, Dual-CAR technology, Off-the-shelf CAR-T products, and CAR-T products for the treatment of refractory solid tumors.

On February 26, 2019 Kleo Pharmaceuticals Inc., a unique immuno-oncology company developing next-generation bispecific compounds designed to emulate or enhance the activity of biologics, reported that its Chief Executive Officer Douglas J. Manion, M.D., FRCP(C), will present at the 16th Annual BIO Asia International Conference, to be held March 5-6, 2019, at the Grand Hyatt Tokyo in Tokyo, Japan (Press release, Kleo Pharmaceuticals, FEB 26, 2019, View Source [SID1234533675]).

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Dr. Manion will present an overview of Kleo’s development strategy for its pipeline of small molecule and synthetic peptide compounds that function similar to highly complex biologics, while offering multiple potential advantages. The overview will also outline Kleo’s key value drivers including the three proprietary technology platforms that drive in-house drug development and partnership opportunities, the multiple in-house and collaborative channels through which it is building its immuno-oncology pipeline, and its discovery collaboration with PeptiDream.

Kleo is well-funded to achieve multiple preclinical and early clinical milestones following the November 2018 closing of an oversubscribed $21 million Series B financing to advance its first clinical candidates through IND-enabling studies and into the clinic in 2020.

Details of Kleo’s presentation are as follows:

Event: 16th Annual BIO Asia International Conference

Date: Tuesday, March 6th, 2019

Time: 8:45 AM JST

Location: Grand Hyatt Tokyo, Drawing Room, 2nd floor

On February 26, 2019 OPKO Health, Inc. (NASDAQ: OPK) reported its operating and financial results for the three and twelve months ended December 31, 2018 as well as provide guidance on expected revenues and operating expenses for the first quarter 2019 after the close of the U.S. financial markets on Wednesday, February 27, 2019 (Press release, Opko Health, FEB 26, 2019, View Source [SID1234533691]).

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OPKO’s senior management will provide a business update and discuss its financial results in a live conference call and audio webcast beginning at 4:30 p.m. Eastern time on Wednesday, February 27, 2019.

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 on Wednesday, February 27, 2019. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN: 866-634-2258
INTERNATIONAL DIAL-IN: 330-863-3454
PASSCODE: 4254518
WEBCAST: View Source
For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately 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 4254518. The replay can be accessed for a period of time on OPKO’s website at View Source.

On February 26, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported that it will provide a comprehensive update to the company’s clinical-stage pipeline at its 2019 Research and Development Day in New York City (Press release, CytomX Therapeutics, FEB 26, 2019, View Source [SID1234533709]).

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Members of the CytomX management team including Sean McCarthy, D.Phil. president, chief executive officer and chairman; Rachel Humphrey, M.D, chief medical officer and Michael Kavanaugh, M.D., chief scientific officer and head of research and non-clinical development, will lead presentations beginning at 8:00 a.m. EST. Alex Spira, M.D., Ph.D., FACP, Director, Virginia Cancer Specialists Research Institute, Assistant Professor, Johns Hopkins School of Medicine and Medical Director, US Oncology Lung Program will discuss his views on industry trends as well as his experiences as a clinical trial investigator for PROCLAIM-CX-072 and PROCLAIM-CX-2009.

"Our inaugural R&D Day will showcase the tremendous progress CytomX has made in building a pipeline of novel anti-cancer agents with our highly innovative Probody technology platform," said Sean McCarthy, D. Phil, president, chief executive officer and chairman of CytomX Therapeutics. "Several years ago, we set out to reimagine and reinvent therapeutic antibodies so we could make a big difference for cancer patients. The emerging clinical data from our two lead programs support the utility of our Probody technology in achieving this vision and sets us on a path to building the long-term, integrated biotechnology company we have always envisaged."

2019 Research and Development Day Program Highlights

CX-072 Anti-PD-L1 Probody Therapeutic Monotherapy: Continues to Demonstrate Favorable Safety and Durable Anti-Cancer Activity with Encouraging Early Snapshot of Data from Expansion Cohorts in Select Tumor Types at 10 mg/kg:

CX-072 is a wholly owned Probody therapeutic targeting programmed cell death ligand 1 (PD-L1). The Company’s PROCLAIM-CX-072 Monotherapy dose escalation (Parts A and A2) trial is complete without a maximum tolerated dose (MTD) having been reached. Of 24 efficacy evaluable patients with generally weakly immunogenic tumors and treated with doses greater than or equal to 3 mg/kg of CX-072, 12 (50%) demonstrated tumor shrinkage including four partial responses; one confirmed partial response (ongoing), 2 unconfirmed partial responses who are off study and one unconfirmed partial response (ongoing with confirmation scan pending). CX-072 as monotherapy was generally well tolerated in the study.

CytomX selected 10 mg/kg as the dose for its expansion cohorts (Part D). This dose was chosen because it was estimated to achieve a greater than 98% receptor occupancy of PD-L1 expressed on the tumor, demonstrated a favorable safety profile, and demonstrated evidence of biological activity. Pharmacokinetic exposure at the 10 mg/kg dose was sustained above the target level regardless of anti-drug antibody (ADA) status (8 of 13 evaluated patients were positive, 4 were negative, and one had unknown status as of December 2018).

Today, the company will present preliminary data from the Company’s PROCLAIM-CX-072 Part Devaluating CX-072 at 10 mg/kg in patients with triple negative breast cancer (TNBC), undifferentiated pleomorphic sarcoma (UPS), cutaneous squamous cell carcinoma (cSCC) and anal squamous cell carcinoma (SCC) as of a February 6, 2019 data cutoff. Additional cohort expansions in Merkel cell carcinoma, cancers with high tumor mutational burden (hTMB), thymic cancer and small bowel adenocarcinoma are underway. For the TNBC, UPS, SCC and cSCC cohorts, preliminary data from 34 efficacy evaluable patients, showed a preliminary pattern of anti-cancer activity generally consistent with historical data for other PD inhibitors. Of 50 patients evaluable for safety in the four cancers tested as of the data cutoff date, CX-072 as monotherapy was generally well tolerated, with 2 (4%) patients experiencing a Grade 3/4 treatment-related adverse events (TRAE), 2 (4%) patients experiencing a Grade 3/4 immune-related adverse events (irAE) and no discontinuation for treatment-related toxicity. These data compare favorably to historical controls where the rate of Grade 3/4 TRAEs in patients receiving PD-pathway inhibitors and TRAEs leading to discontinuation are 15% and 8%, respectively. Today’s featured speaker, Dr. Spira, will review a case study of a patient from PROCLAIM-CX-072.

CX-072 anti-PD-L1 Probody Therapeutic in Combination with YERVOY (ipilimumab) Continues to Demonstrate Durable Anti-Cancer Activity and a Favorable Safety Profile:

The Company’s PROCLAIM-CX-072 combination dose escalation of CX-072 with ipilimumab (Part B1) is complete with the MTD defined as the combination of 3 mg/kg of ipilimumab and 10 mg/kg of CX-072. Of 19 patients evaluable for efficacy, four (21%) patients experienced confirmed responses as of the February 6, 2019 data cutoff. Three of the four confirmed responses remained on drug as of the data cutoff, including one confirmed complete response (82 weeks) and 2 confirmed partial responses (59 and 64 weeks). Of 27 patients treated with CX-072 in combination with ipilimumab, all with the full ipilimumab dose of 3 mg/kg or above, the combination was generally well tolerated. As of the February 6, 2019 data cutoff, 7 (26%) patients reported a Grade 3/4 TRAE and 3 (11.1%) patients reported a Grade 3/4 irAE. No patients experienced a Grade 3/4 irAE in the 3 mg/kg ipilimumab plus 10 mg/kg of CX-072 arm. These data generally compare favorably with historical controls where the rate of Grade 3/4 treatment-related adverse events in patients receiving a low dose of nivolumab (1 mg/kg) and full dose ipilimumab (3 mg/kg) was reported to be 55%.1

CX-2009, a First-In-Class CD166 Targeting Probody Drug Conjugate, Demonstrates Anti-Cancer Activity Across a Range of Doses and Tumor Types and an Encouraging Safety Profile

CX-2009 is a wholly owned Probody drug conjugate (PDC) that targets CD166, an antigen that is broadly and highly expressed in many types of cancer. CX-2009 is conjugated with the DM4 payload, a clinically-validated toxin licensed from ImmunoGen, Inc.

The Company’s PROCLAIM-CX-2009 dose escalation trial is complete. Patients with breast, castration-resistant prostate, cholangiocarcinoma, endometrial, head and neck, non-small cell lung and ovarian cancers were enrolled with the study comprised of two parts (Part A – unselected patients; Part A2 – patients selected for high CD166 levels). During dose escalation, 76 patients were treated at doses ranging from 0.25 to 10 mg/kg of CX-2009 every 3 weeks. The MTD was not reached. As of the February 6, 2019 data cutoff date, preliminary data from 46 efficacy evaluable patients demonstrated evidence of anti-cancer activity observed at doses of greater than or equal to 4 mg/kg. Tumor shrinkage was observed in 16 (34.8%) patients in multiple tumor types with 5 unconfirmed partial responses (2 each in ovarian and breast cancers and one in head and neck cancer). Of note, comparable levels of anti-cancer activity was observed in patients who were PD-pathway inhibitor naive or resistant, respectively.

CX-2009 was generally well tolerated in the trial with 23 (30.3%) patients experiencing a Grade 3/4 TRAE. The most common adverse event observed was ocular toxicity, an anticipated toxicity associated with the DM4 payload. Other Grade 3/4 TRAEs included liver function test abnormalities, gastrointestinal disorders and nervous system disorders. Currently, dose optimization is underway to further to inform dose selection. Ocular toxicity prophylaxis has been introduced to this dose optimization phase. Dr. Spira, will also review a case study of a patient from PROCLAIM-CX-2009.

"These preliminary data from our ongoing PROCLAIM program provide additional proof of concept for both CX-072 and CX-2009, as well as the Probody platform itself," said Rachel Humphrey, M.D, chief medical officer of CytomX Therapeutics. "CX-072 continues to behave as designed with a safety profile as monotherapy and in combination that has the potential for meaningful differentiation from other PD-pathway inhibitors, while maintaining the expected efficacy for the class. As additional data emerge from the ongoing clinical program, we will be further defining the utility of this agent in the rapidly evolving oncology landscape."

Continued Dr. Humphrey, "Our CX-2009 data shows the ability of our technology to potentially address an entirely new class of highly expressed tumor antigens, with the opportunity to make otherwise undruggable targets available to patients with a wide variety of cancers."

The Next Wave of Innovation

Dr. Michael Kavanaugh will present an update on the broad potential of the Probody platform across a range of therapeutic antibody formats including Probody Drug Conjugates and the application of Probody technology to the emerging modality of T-Cell engaging Bispecific Antibodies (Probody TCBs). Regarding PDCs, Dr. Kavanaugh will describe the company’s strategy for PDC target selection and validation. Regarding Probody TCBs, Dr. Kavanaugh will outline the potential of Probody technology to enable the expansion of the TCB modality to the treatment of solid tumors. Ongoing work aimed at the further optimization of the company’s innovative Probody technology platform will also be presented.

Anticipated 2019 Milestones

PROCLAIM-CX-072 (PD-L1 Probody Therapeutic)

Additional data from monotherapy expansions in selected tumor types at 10 mg/kg arm (Part D).
Initiation of expansion studies of combination with ipilimumab in selected tumor types.
Preliminary data from the combination arm with Zelboraf (vemurafenib) in patients with V600E BRAF-positive melanoma (Part C).
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate)

Additional safety and efficacy data from the monotherapy dose escalation arm (Parts A and A2).
Initiation of an expansion cohort(s) in selected tumor types at a selected dose.
CytomX reported that due to a recent program and portfolio prioritization, the company has decided to indefinitely postpone the clinical trials of CX-188, a PD-1 Probody. The Company may elect to initiate clinical trials of CX-188 in the future.

Bristol-Myers Squibb (BMS) Collaboration Update

As part of our strategic oncology collaboration, BMS has advanced BMS-986249, a CTLA-4 Probody therapeutic, into an ongoing Phase 1/2 clinical trial. BMS has stated that they anticipate preliminary data from this trial in 2019.
In January 2019, BMS provided CytomX notification of termination for three collaboration discovery targets due to portfolio reprioritization. The termination of these targets does not affect other ongoing collaboration discovery and development activities that include BMS-986249.
CytomX 2019 Research and Development Day Webcast

CytomX will host its 2019 Research and Development Day this morning from 8:00 a.m. – 11:30 a.m. ET in New York, NY. The event will be webcast live under the "Investors & News" section of the CytomX website at View Source Please connect to the webcast several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. An archived webcast replay will be available on the Company’s website for 90 days following the event.

FY 2018 Financial Results Conference Call and Webcast

CytomX will report full-year 2018 financial results tomorrow, Wednesday, February 27, 2019, after the close of U.S. markets. Following the announcement, the Company will host a conference call beginning at 5:00 p.m. ET to discuss its results. Participants may access the live audio webcast of the teleconference from the "Investors & News" section of CytomX’s website. An archived replay of the webcast will be available on CytomX’s website until March 6, 2019. The live audio of the conference call can also be accessed by telephone by dialing either (877) 809-6037 (United States and Canada) or (615) 247-0221 (international) and referencing the conference ID 3748238. An archived webcast replay will be available on the Company’s website from February 27, 2019, until March 6, 2019.