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Veracyte Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On May 7, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported the closing of its public offering of 6,325,000 shares of common stock, including 825,000 shares sold upon full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $23.25 per share (Press release, Veracyte, MAY 7, 2019, View Source [SID1234535885]). The net proceeds to Veracyte from the offering were approximately $137.9 million, after deducting underwriting discounts and commissions and estimated offering expenses.

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Morgan Stanley & Co. LLC and SVB Leerink LLC acted as lead book-running managers for the offering. William Blair acted as a book-running manager and BTIG and Janney Montgomery Scott acted as co-managers.

The public offering was made pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission on May 2, 2019. This offering was made solely by means of a prospectus supplement and accompanying prospectus relating to and describing the terms of the offering, copies of which may be obtained by contacting Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 01220, by email at [email protected] or by telephone at (800) 808-7525, ext. 6132.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Veracyte, Afirma, Percepta, Envisia, Know by Design, the Veracyte logo and the Afirma logo are trademarks of Veracyte, Inc.

Atara Biotherapeutics to Announce First Quarter 2019 Financial Results and Host Conference Call on Thursday, May 9, 2019

On May 7, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that its first quarter 2019 financial results will be released before the market opens on Thursday, May 9, 2019 (Press release, Atara Biotherapeutics, MAY 7, 2019, View Source [SID1234535884]). Following the release, the Company will host a live conference call and webcast at 8:30 a.m. EDT to discuss the Company’s financial results and recent operational highlights.

Analysts and investors can participate in the conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 1956289. A live audio webcast can be accessed by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company’s website for approximately 14 days following the live webcast.

Supernus Announces First Quarter 2019 Financial Results

On May 7, 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 financial results for the first quarter of 2019 and associated Company developments (Press release, Supernus, MAY 7, 2019, View Source [SID1234535883]).

Commercial Update

First quarter 2019 product prescriptions for Trokendi XR and Oxtellar XR, as reported by IQVIA, totaled 199,520, an 11.0% increase over the first quarter of 2018.

In the fourth quarter of 2018, wholesalers, distributors, and pharmacies increased their inventory holdings as compared to the prevailing inventory levels in the third quarter of 2018. As previously disclosed, the Company estimated that this caused net product sales to be approximately $10 million higher in the fourth quarter of 2018 than it would have been otherwise, had inventory levels remained consistent quarter to quarter.

This process was effectively reversed in the first quarter of 2019, with net product sales decreasing in the first quarter of 2019 by an estimated $10 million, as compared both to the prior year as well as the prior quarter.

In addition, net product sales were impacted by the growing prevalence of high deductible patient plans, their seasonal effect on first quarter prescription trends, and the seasonal increase in our use of copay assistance. Consequently, gross to net deductions were higher by approximately $4 million, as compared to the first quarter of 2018.

Progress of Product Pipeline

During its Investor Day held on April 16, 2019, the Company provided a product pipeline update as set forth below.

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

During March 2019, the Company announced data from the fourth and final Phase III study for SPN-812 (P304) that confirm positive results from the previous three Phase III studies on SPN-812, announced in December 2018.
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 10.5 months, which the Company believes 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 a pivotal Phase III program for the treatment of bipolar disorder in the fourth quarter of 2019.
Operating Expenses

Research and development expenses in the first quarter of 2019 were $15.4 million, as compared to $18.9 million in the same quarter last year. This decrease is due to the completion of the four Phase III clinical trials for SPN-812, three of which were completed in December 2018 and one completed in March 2019. The decrease was partially offset by the manufacture of validation and registration lots for SPN-812 to support the Company’s upcoming submission of its New Drug Application (NDA).

Selling, general and administrative expenses in the first quarter of 2019 were $41.0 million, as compared to $36.8 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.

Operating Earnings and Earnings Per Share

Operating earnings in the first quarter of 2019 were $25.4 million, compared to $31.4 million in the same quarter last year. The decrease in operating earnings was primarily due to decreased net product sales. Excluding the negative impact to net product sales from the aforementioned inventory drawdown in the first quarter, operating earnings would have been approximately $9.5 million higher than in 2018.

Net earnings (GAAP) in the first quarter of 2019 were $18.3 million, or $0.34 per diluted share, compared to $26.4 million, or $0.49 per diluted share, in the same period last year. In addition to the impact of lower operating earnings for the first quarter of 2019, net earnings (GAAP) were subject to a higher effective tax rate in the first quarter of 2019 relative to the first quarter of 2018. The tax rate in the first quarter of 2018 benefited from stock option exercises.

Weighted-average diluted common shares outstanding were approximately 54.0 million in the first quarter of 2019, as compared to approximately 53.8 million in the prior year period.

"Our financial results for the first quarter were adversely impacted by several factors, converging all at once: the fourth quarter 2018 inventory buildup impacting shipments in first quarter 2019: first quarter seasonal insurance plan dynamics putting pressure on prescription growth coupled with increased gross-to-net deductions through our copay assistance; and the increase in the effective tax rate compared to same period in 2018," said Jack Khattar, President and CEO of Supernus. "Aside from the effective tax rate, these one-time events are not expected to have a continuing effect in the subsequent quarters. We have already seen in the second quarter of 2019 a normalization of shipments and prescription trends"

Balance Sheet Highlights

As of March 31, 2019, the Company had $815.5 million in cash, cash equivalents, marketable securities, and long term marketable securities, compared to $774.8 million at December 31, 2018. This increase primarily reflects cash generated from operations in the first quarter of 2019.

Financial Guidance

For full year 2019, the Company reiterates its prior guidance for net product sales, research and development expenses, operating earnings, and effective tax rate as set forth below:

Net product sales in the range of $435 million to $455 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%
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, May 8, 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: 8139879
Conference Call Name: Supernus Pharmaceuticals First Quarter 2019 Earnings Conference Call
Following the live call, a replay will be available on the Company’s website, www.supernus.com, under "Investor Relations".

Iovance Biotherapeutics Reports First Quarter 2019 Financial Results and Provides Corporate Update

On May 7, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported first quarter 2019 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, MAY 7, 2019, View Source;p=RssLanding&cat=news&id=2397573 [SID1234535881]).

"We have made great progress in recent months in advancing TIL therapy toward commercialization. In April, we dosed the first patient in the pivotal study, Cohort 4 of the innovaTIL-01 melanoma trial, bringing us a step closer to our goal of filing for regulatory approval of lifileucel in 2020," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "We are pleased that three Iovance abstracts submitted to ASCO (Free ASCO Whitepaper) have been accepted, two of which include data updates from our fully enrolled Cohort 2 of our melanoma program and data from our ongoing LN-145 cervical study being presented for the first time in a medical conference at the 2019 meeting."

Recent Achievements and Upcoming Milestones

Clinical

In April 2019, the company announced that the first patient was dosed in Cohort 4 of the pivotal innovaTIL-01 study of lifileucel in metastatic melanoma.
New interim data from Cohort 2 of the innovaTIL-01 melanoma study and data from the ongoing innovaTIL-04 cervical cancer study will be presented on June 1, 2019 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.
The company closed the IOV-LUN-201 study and instead will add an additional arm to the IOV-COM-202 study, adapting clinical development plans to reflect advances in the treatment landscape for non-small cell lung cancer.
The protocol for innovaTIL-04, the Phase 2 study in cervical cancer, was amended to increase the sample size to 59 and to modify the primary endpoint of Objective Response Rate (ORR) to be determined by a Blinded Independent Review Committee (BIRC). The company made the changes in anticipation of a meeting with the U.S. Food and Drug Administration (FDA) planned for later this year to discuss the registration pathway for LN-145 in cervical cancer.
Regulatory

In February 2019, LN-145 received Fast Track designation from the FDA for the cervical cancer indication.
Research

In April 2019, persistence and biomarker data from Cohort 2 of the innovaTIL-01 study of lifileucel in the treatment of advanced melanoma were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. The presentation described results of an analysis of circulating T cells at 42 days post-infusion, highlighting the uniqueness of clonal profiles in TIL therapy in melanoma. The results support potential use of a polyclonal product such as Iovance bulk TIL in the treatment of melanoma and likely other cancers with high mutational load solid tumors.
Researchers at Iovance have generated data in collaboration with Roswell Park Cancer Center from the 22-day Gen 2 process of generating TIL from patient derived bladder cancer tumor tissue. An abstract describing the data has been accepted for presentation at the upcoming AACR (Free AACR Whitepaper) "Bladder Cancer: Transforming the Field" conference taking place May 18-21, 2019.
Corporate

In May 2019, the company opened a satellite office in Philadelphia, Pennsylvania. The office will house various functions including members of the Iovance legal and manufacturing teams.
First Quarter 2019 Financial Results

Net loss for the quarter ended March 31, 2019 was $37.0 million, or $0.30 per share, compared to net loss of $26.5 million, or $0.31 per share for the quarter ended March 31, 2018.

Research and development expenses were $30.9 million for the quarter ended March 31, 2019, an increase of $11.0 million, compared to $19.9 million for the same period ended March 31, 2018. The increase in research and development expenses was primarily attributable to an increase in the total number of patients in our clinical studies which in turn results in higher manufacturing and clinical study costs, technology transfer expenses and an increase in research and development headcount.

General and administrative expenses were $9.1 million for the quarter ended March 31, 2019, an increase of $2.1 million compared to $7.0 million for the same period ended March 31, 2018. The increase was primarily attributable to an increase in general and administrative headcount and higher stock based compensation.

Cash, Cash Equivalents and Short-term Investments

At March 31, 2019, the company held $440.0 million in cash, cash equivalents, and short-term investments compared to $468.5 million at December 31, 2018.

Webcast and Conference Call

Iovance will host a conference call and live audio webcast to discuss financial results and provide a corporate update today at 4:30 p.m. EDT.

To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 7393657. The live webcast can be accessed under "News & Events: Investor Calendar" in the Investors section of the Company’s website at www.iovance.com or at the link: View Source An archived webcast will be available in the Investors section of www.iovance.com for thirty days following the call.

Kura Oncology Reports First Quarter 2019 Financial Results and Highlights Upcoming Milestones

On May 7, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported first quarter 2019 financial results and highlighted upcoming milestones (Press release, Kura Oncology, MAY 7, 2019, View Source [SID1234535880]).

"We have made considerable progress over the past quarter, as we continue to execute against our first registration-directed trial for tipifarnib in patients with HRAS mutant squamous head and neck cancers," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Meanwhile, our elucidation of the CXCL12 pathway as a therapeutic target of tipifarnib, coupled with identification of associated farnesylated proteins, offers the potential to significantly expand the population of patients who may benefit from treatment with tipifarnib. Ultimately, we believe that CXCL12 pathway biomarkers could enable registrational strategies for tipifarnib in multiple hematologic and solid tumor indications."

"Now, we look forward to a series of important milestones," continued Dr. Wilson, "beginning with an update from our ongoing Phase 2 trial of tipifarnib in angioimmunoblastic T-cell lymphoma (AITL) and CXCL12-positive peripheral T-cell lymphoma (PTCL), which was accepted for oral presentation at both the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress and the International Conference on Malignant Lymphoma (ICML) next month. This will be followed by additional data from our ongoing Phase 2 trial of tipifarnib in HRAS mutant solid tumors, including head and neck squamous cell carcinoma (HNSCC) and other squamous cell carcinomas (SCCs), as well as an update from our ongoing Phase 2 trial in chronic myelomonocytic leukemia (CMML) later in the year."

Recent Highlights

Registration-directed trial of tipifarnib in HRAS mutant HNSCC – Kura’s global, multi-center, open-label, non-comparative registration-directed trial of tipifarnib continues on track. The clinical trial has two cohorts: A non-interventional screening and outcomes cohort (SEQ-HN) and a treatment cohort (AIM-HN). AIM-HN is designed to enroll at least 59 evaluable patients with HRAS mutant HNSCC who have received prior platinum-based therapy. AIM-HN initiated in November 2018 and is expected to take approximately two years to fully enroll.

Farnesylated proteins associated with CXCL12 expression – In April 2019, Kura reported new findings at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting suggesting that gene expression of the exclusively farnesylated proteins RHOE and PRICKLE2 is strongly associated with CXCL12 expression in bone marrow stroma. These findings provide key evidence supporting the inhibition of the CXCL12 pathway as a mechanism of action mediating the activity of tipifarnib and other farnesyl transferase inhibitors.

Potential expansion to other CXCL12+ lymphoma indications – Kura reported additional findings at AACR (Free AACR Whitepaper) identifying CXCL12 expression as a potential biomarker of clinical benefit in patients with diffuse large B-cell lymphoma (DLBCL) as well as mycosis fungoides, the most common form of cutaneous T-cell lymphoma (CTCL). The results were obtained from an analysis of a subset of samples from a previously conducted Phase 2 trial of tipifarnib in patients with relapsed and refractory lymphomas and are consistent with similar findings from the Company in other indications such as PTCL, acute myeloid leukemia (AML) and pancreatic cancer.

Emerging pipeline of clinical-stage drug candidates – Kura is advancing two additional pipeline programs: KO-947, a small molecule inhibitor of extracellular signal-related kinase (ERK), and KO-539, a potent and selective small molecule inhibitor of the menin-mixed lineage leukemia (menin-MLL) interaction. The Company continues to evaluate dosing regimens for KO-947 and anticipates having data from its Phase 1 clinical trial later this year. Meanwhile, the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for KO-539 and the Company is preparing to initiate a Phase 1 clinical trial in patients with relapsed or refractory AML in mid-2019.

Financial Results

Research and development expenses for the first quarter of 2019 were $10.4 million, compared to $11.6 million for the first quarter of 2018.

General and administrative expenses for the first quarter of 2019 were $4.6 million, compared to $3.4 million for the first quarter of 2018.

Net loss for the first quarter of 2019 was $13.9 million, compared to $14.6 million for the first quarter of 2018.

Cash, cash equivalents and short-term investments totaled $165.5 million as of March 31, 2019, compared with $179.0 million as of December 31, 2018.

Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2021.

Upcoming Milestones

Additional data from the ongoing Phase 2 trial of tipifarnib in PTCL, including duration of response data from the AITL cohort and additional data from the CXCL12-positive PTCL cohort, at EHA (Free EHA Whitepaper) and ICML in June 2019

Additional data on biomarkers associated with elevated CXCL12 expression at EHA (Free EHA Whitepaper) and ICML in June 2019

Additional data from the ongoing Phase 2 trial of tipifarnib in HRAS mutant solid tumors, including HNSCC and other SCCs, in the second half of 2019

Additional data from the ongoing Phase 2 trial of tipifarnib in CMML in 2019

Data from the Phase 1 dose-escalation trial of KO-947 in 2019

Initiation of the Phase 1 clinical trial of KO-539 in mid-2019

Conference Call and Webcast

Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, May 7, 2019, to discuss the financial results for the first quarter 2019 and provide a corporate update. The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers and entering the conference code: 4436235. A live webcast of the call will be available from the Investors and Media section of the Company’s website at www.kuraoncology.com, and will be archived there for 30 days.