On February 28, 2019 Flow Pharma Inc., a San Francisco Bay Area biotechnology company focused on personalized vaccine development, reported that it has selected BGI Americas Inc. to provide the sequencing services required for all FlowVax neoantigen-based personalized therapeutic cancer vaccines under development by Flow Pharma (Press release, Flow Pharma, FEB 28, 2019, View Source [SID1234554003]).

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The first two Flow Pharma products under development are FlowVax HPV for the treatment of cervical cancer and FlowVax BreastCA for the treatment of breast cancer. FlowVax Breast CA will be a personalized therapeutic vaccine requiring patient-specific gene sequencing.

"The exciting new area of personalized therapeutic cancer vaccines requires rapid, accurate genomic and transcriptomic sequencing. BGI Americas is unique in providing next generation sequencing services using its own unique DNBseq sequencing technology based on combinatorial probe-anchor synthesis (cPAS), linear isothermal rolling-circle replication and DNA nanoball (DNB) technology," said Victor Zhang, Ph.D., CEO of BGI Americas. "BGI has a strong track record supporting the therapeutic and biomarker development of top biopharma and biotech companies. Our DNBseq technology has been validated by leading academic centers and industry users and will deliver strong value in our collaboration with Flow Pharma."

"In order to make a personalized therapeutic cancer vaccine, you have to know the genomic information of the patient’s tumor as well as that of the patient. Speed and accuracy are both critical. Once we have these gene sequences, we can use AI-augmented bioinformatics tools to quickly identify tumor targets for T-cell attack and then rapidly load these targets into a FlowVax vaccine customized for that particular patient." Said Lu Wang, Ph.D., Flow Pharma bioinformatics team leader

"We have spent a decade developing the FlowVax vaccine platform. FlowVax is optimized to simultaneously deliver multiple unmodified peptide targets for killer T-cell attack. Each of the chemical components used in the FlowVax platform are currently part of an FDA approved vaccine or pharmaceutical, simplifying our regulatory pathway," said Charles Herst, Ph.D., Flow Pharma chief science officer. "Personalized FlowVax therapeutic vaccines can be manufactured quickly and efficiently, keeping the cost down and getting the therapy in the hands of treating physicians soon after the diagnosis is made, for maximum efficacy."

"We believe that BGI’s DNBseq NGS platform is the best in class for the rigorous requirements of personalized therapeutic cancer vaccine development. The fact that BGI Americas provides professional and competitive genomic sequencing services along with experience and knowledge in supporting drug development, allows us to become a full-stack company in the space without the time and expense required to bring gene sequencing technology in-house," said Reid Rubsamen, M.D., CEO of Flow Pharma.

On February 28, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) reported financial results for the fourth quarter and full year of 2018 and its outlook for 2019 (Press release, Pacira Pharmaceuticals, FEB 28, 2019, View Source;p=RssLanding&cat=news&id=2389460 [SID1234533797]).

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2018 Financial Highlights

Fourth quarter EXPAREL net product sales of $94.4 million

Full year EXPAREL net product sales of $331.1 million

Fourth quarter GAAP net income of $8.3 million or $0.20 per diluted share

Fourth quarter non-GAAP net income of $19.8 million or $0.47 per diluted share

Full year GAAP net loss of $0.5 million or $0.01 per basic and diluted share

Full year non-GAAP net income of $43.5 million or $1.04 per diluted share
"Pacira had a landmark 2018 with record revenues underscoring the growing marketplace adoption of EXPAREL as a fundamental component of opioid-sparing pain management protocols at influential academic centers and also the success of our brachial plexus nerve block launch," said Dave Stack, chairman and chief executive officer of Pacira. "There is great enthusiasm among a growing number of anesthesiologists who are using regional nerve blocks and field blocks to revolutionize postsurgical pain management and improve patient outcomes. We are also seeing robust growth in new accounts driven primarily by ambulatory, plastic, and oral surgery centers seeking to differentiate their practices by providing patients with an effective, long-acting non-opioid option for managing postsurgical pain. Finally, our significant partnership with Johnson and Johnson continues to drive uptake with EXPAREL being integrated across its world class educational platforms and comprehensive offering of orthopedic procedural solutions. Altogether this strong growth trajectory provides us with a solid operating foundation to support the strategic expansion of our commercial and clinical offering within the non-opioid pain management and regenerative health space."

"This substantial momentum has continued into 2019 and we plan to build on our success by executing on multiple growth opportunities, including expanding the role of EXPAREL as a catalyst for shifting inpatient procedures to the ambulatory setting, and building out our differentiated non-opioid portfolio with innovative products that address the need for improving patients’ journeys along the neural pain pathway. We believe this strategy provides the greatest opportunities to build value in both the near- and long-term," concluded Mr. Stack.

Recent Highlights

EXPAREL manufacturing capacity expansion to meet growing demand. In February 2019, Pacira announced that commercial production of EXPAREL is now underway at a custom suite in Swindon, UK created under the company’s partnership with Thermo Fisher Scientific Pharma Services (formerly Patheon UK Limited). This suite was designed to mirror the company’s existing facility at the Pacira Science Center Campus in San Diego, CA and is expected to double the company’s manufacturing capacity. Through the partnership, the companies are developing a second dedicated suite that is expected to enable another doubling of EXPAREL manufacturing capacity in approximately two years.

Phase 4 EXPAREL study achieves statistically significant reductions in opioid consumption and pain scores in C-Section patients. In January 2019, Pacira announced that its Phase 4 study of EXPAREL in patients undergoing Cesarean section (C-section) achieved its primary endpoint with a statistically significant reduction in total postsurgical opioid consumption through 72 hours (P<0.05). EXPAREL also achieved statistical significance for reduction in pain intensity scores through 72 hours (P<0.05). The full study results will be submitted for publication in peer-reviewed medical literature later this year.

Centers for Medicare and Medicaid Services establish new reimbursement for EXPAREL. In November 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a policy to provide separate Medicare reimbursement for EXPAREL when administered in ambulatory surgical centers (ASCs) through establishment of the product-specific billing code of C9290. This code, which provides payment for EXPAREL at $1.22 per milligram, sets national Medicare reimbursement rates for EXPAREL administered in ASCs. In addition, the American Dental Association published a CDT code (D9613) to report infiltration of a sustained-release therapeutic drug in oral surgery procedures. Both codes became effective on January 1, 2019.

New data show EXPAREL significantly reduces opioid use, hospital length of stay and total hospitalization costs following TKA. In November 2018, Pacira announced new data were published in The Journal of Medical Economics on the use of EXPAREL to manage postsurgical pain following total knee arthroplasty (TKA). The findings showed that patients receiving EXPAREL had a significant reduction in opioid use, hospital length of stay (LOS), and total hospitalization costs compared to TKA patients who did not receive EXPAREL. Patients receiving EXPAREL also had increased likelihood to be discharged home rather than a skilled nursing facility.
Fourth Quarter 2018 Financial Results

EXPAREL net product sales were $94.4 million in the fourth quarter of 2018, a 20% increase over the $78.7 million reported for the fourth quarter of 2017.

Total revenues were $95.1 million in the fourth quarter of 2018, a 20% increase over the $79.1 million reported for the fourth quarter of 2017.

Total operating expenses were $82.9 million in the fourth quarter of 2018, compared to $70.6 million in the fourth quarter of 2017.

GAAP net income was $8.3 million, or $0.20 per share (basic and diluted) in the fourth quarter of 2018, compared to GAAP net income of $4.6 million, or $0.11 per share (basic and diluted), in the fourth quarter of 2017.

Non-GAAP net income was $19.8 million, or $0.48 per share (basic) and $0.47 per share (diluted), in the fourth quarter of 2018, compared to non-GAAP net income of $16.0 million, or $0.39 per share (basic) and $0.38 per share (diluted), in the fourth quarter of 2017.

Pacira had 41.1 million basic weighted average shares of common stock outstanding in the fourth quarter of 2018.

Pacira had 42.2 million diluted weighted average shares of common stock outstanding in the fourth quarter of 2018.
Full-Year 2018 Financial Results

EXPAREL net product sales were $331.1 million in 2018, a 17% increase over the $282.9 million reported in 2017.

Total revenues were $337.3 million in 2018, an 18% increase over the $286.6 million reported in 2017.

Total operating expenses were $321.4 million in 2018, compared to $311.6 million in 2017.

GAAP net loss was $0.5 million, or $0.01 per share (basic and diluted) in 2018, compared to a GAAP net loss of $42.6 million, or $1.07 per share (basic and diluted) in 2017.

Non-GAAP net income was $43.5 million, or $1.06 per share (basic) and $1.04 per share (diluted), in 2018, compared to non-GAAP net income of $8.6 million, or $0.22 per share (basic) and $0.21 per share (diluted), in 2017.

Pacira ended 2018 with cash, cash equivalents, short-term and long-term investments ("cash") of $409.3 million.

Pacira had 40.9 million basic weighted average shares of common stock outstanding in 2018.

For non-GAAP measures, Pacira had 41.9 million diluted weighted average shares of common stock outstanding in 2018.
2019 Outlook

Pacira announces its full year 2019 financial guidance as follows. Pacira expects:

EXPAREL net product sales of $400 million to $410 million.

Non-GAAP gross margins of 75% to 76%.

Non-GAAP research and development (R&D) expense of $60 million to $70 million.

Non-GAAP selling, general and administrative (SG&A) expense of $165 million to $175 million.

Stock-based compensation of $30 million to $35 million.
See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2019 Financial Guidance" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Thursday, February 28, 2019, at 8:30 a.m. ET. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 6050757.

A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 6050757. The replay of the call will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income (loss), non-GAAP net income (loss) per share, non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D) expense and non-GAAP selling, general and administrative (SG&A) expense, because such measures exclude milestone revenue, stock-based compensation, amortization of debt discount, loss on early extinguishment of debt, exit costs related to the discontinuation of DepoCyt(e) production and loss on an unexercised investment purchase option.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D expense and SG&A expense outlook for 2019 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and the company’s future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, and a reconciliation of our GAAP to non-GAAP 2019 financial guidance for gross margins, R&D expense and SG&A expense.

on February 28, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer, reported updated interim results from its ongoing Phase 2 study investigating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced non-small cell lung cancer (NSCLC) (Press release, Heat Biologics, FEB 28, 2019, View Source [SID1234533839]). The results were presented today at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium by Daniel Morgensztern, M.D., Associate Professor of Medicine and Director of Thoracic Oncology, Washington University School of Medicine, and Lead Investigator in the trial. Data were presented on both Cohort A and Cohort B of the trial. Cohort A enrolls only previously treated patients who have never received a checkpoint inhibitor (CPI), while Cohort B enrolls patients who received a minimum of 4 months of treatment with a CPI as part of their prior therapy, but subsequently had documented progressive disease.

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"The treatment landscape for NSCLC has fundamentally changed as the number of patients who receive first line checkpoint inhibitor therapy is rapidly increasing," said COL(ret) George E Peoples, MD, FACS, Heat’s Chief Medical Advisor. "The preliminary data from our Cohort B is increasingly relevant and potentially exciting as it suggests that the addition of HS-110 to nivolumab may restore anti-tumor activity in patients whose disease has progressed after treatment with a CPI."

Jeff Hutchins, Ph.D., Chief Scientific and Operating Officer of Heat said, "The observed response rates and durability of disease stabilization support our mechanistic hypothesis that the broad, T-cell mediated immune response activated by HS-110 may improve patient survival when administered in combination with a CPI. The Cohort B data suggest that HS-110 may improve clinical outcomes for patients who have lost the benefit of treatment with a checkpoint inhibitor. We look forward to completing enrollment in this trial in Q2 and releasing additional results later this year as the data matures."

Highlights for both cohorts are presented below:

Cohort B (patients who progressed after ≥ 4 months of prior treatment with a checkpoint inhibitor)

Of first 20 patients enrolled in this cohort:

Partial response (PR) in 3 patients (15%) per RECIST 1.1 and 4 patients (20%) per investigator assessment

Disease control rate (DCR) of 55%

The 3 RECIST 1.1 PR patients had documented progression on CPI monotherapy immediately preceding study entry

Median progression free survival (mPFS) was 2.7 months (95% CI; 1.8 – 4.0 months)

Cohort A (patients who have never received a CPI prior to study entry)

Of 42 patients enrolled by the cutoff date:

PR in 9 patients (21%) per RECIST 1.1

DCR of 50%

Median overall survival not yet reached (60% still alive with a median follow-up of 14.4 months)

Responses and disease stabilization are durable and long-lasting

Subgroup analyses, predefined in the clinical protocol, were performed for levels of tumor-infiltrating lymphocytes (CD8+ TILs) present in tumors at baseline. A survival benefit [hazard ratio (HR) = 0.39] was observed in patients with levels CD8+ TIL <10% (i.e. "cold" tumors), a population that typically responds poorly to checkpoint inhibitors. The treatment benefit appeared to be independent of PD-L1 status (HR = 0.85)

Immune reactivity to HS-110 was measured via ELISPOT assay (high vs. low compared to median) on patient peripheral blood mononuclear cells obtained before and during treatment with a median overall survival benefit of 6.2 months in the high ELISPOT group

Overall survival was significantly higher in patients that experienced at least one dermal injection site reaction to HS-110 at any time during study treatment, supporting HS-110’s mechanism of action (HR = 0.15 [95% CI: 0.05-0.45], p=0.0001)

For both cohorts, treatment with HS-110 in combination with nivolumab was well tolerated, with no additional toxicities beyond those observed with single agent CPI therapy.

Importantly, data from Cohort B suggest that HS-110 in combination with nivolumab reduced tumor burden in patients whose disease progressed after treatment with a checkpoint inhibitor at any time prior to study entry. Additionally, the deepest responses were observed in three patients whose last treatment immediately preceding enrollment was checkpoint inhibitor monotherapy.

Also of interest is the data regarding overall survival (OS) in patients with low CD8+ TIL (tumor infiltrating lymphocytes) at baseline. Protocol-defined subgroup analysis of patients categorized as ‘high’ or low’ TIL, based on levels of CD8+ cells present in the stroma of their tumor tissue at baseline, demonstrate a survival advantage for the ‘low TIL’ group as compared to the ‘high TIL’ group (not reached vs. 13.8 months; HR = 0.39 [95% CI; 0.06-2.31]. These data are very encouraging as prior studies with nivolumab alone suggest that "cold" tumor patients with lower levels of baseline CD8+ TILs have lower response rates compared to "hot" tumor patients with high levels of CD8+ TILs1.

Trial results are summarized in the company’s updated corporate presentation, along with the official ASCO (Free ASCO Whitepaper)-SITC poster.

Trial Design

The Phase 2 trial is designed to evaluate the safety and efficacy of HS-110 combined with an immune checkpoint inhibitor for the treatment of advanced non-small cell lung cancer. Patients receive weekly HS-110 (1 x 107 cells) administered as 5 intradermal 0.1 mL injections for 18 weeks in combination with bi-weekly nivolumab 240 mg IV administered until confirmed disease progression or unacceptable toxicity, whichever occurs first. The primary endpoint is objective response rate (ORR); secondary endpoints include overall survival (OS), progression-free survival (PFS), disease control rate (DCR) and duration of response (DOR). Exploratory endpoints include correlation of clinical outcomes to baseline CD8+ TILs, PD-L1 expression, peripheral blood tumor mutation burden and ELISPOT analysis.

For further details about the trial and the results presented at ASCO (Free ASCO Whitepaper)-SITC, refer to Heat Bio’s updated corporate presentation, which can be found on the Investors tab of the corporate website View Source

On February 28, 2019 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported financial results for the fourth quarter and full-year ended December 31, 2018 (Press release, G1 Therapeutics, FEB 28, 2019, View Source [SID1234533798]). The company also highlighted 2018 operational results and upcoming 2019 milestones.

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"Data from four randomized Phase 2 trials showed the benefits of trilaciclib across different indications, lines of therapy and chemotherapy regimens," said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. "We have scheduled meetings with U.S. and European regulatory authorities in the first half of 2019 to discuss the totality of data and next steps for the development of trilaciclib. We will provide an update on these meetings in the second quarter."

"We made substantial progress across our three clinical-stage product candidates in 2018. We reported positive results from all four Phase 2 trilaciclib trials, presented proof-of-concept data on lerociclib in breast cancer, initiated a trial of lerociclib in non-small cell lung cancer, and brought our oral selective estrogen receptor degrader G1T48 into the clinic," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "These accomplishments will drive a number of important clinical and regulatory milestones in 2019 in the advancement of our pipeline."

Corporate Highlights

Reported positive multi-lineage myelopreservation data from three randomized, double-blind, placebo-controlled Phase 2 trials of trilaciclib in small cell lung cancer (SCLC): In the fourth quarter, the company presented additional data from its Phase 2 trial of trilaciclib in combination with chemotherapy in first-line SCLC at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, and reported preliminary data from Phase 2 trials in first-line SCLC in combination with chemotherapy/Tecentriq (atezolizumab) and second/third-line SCLC in combination with chemotherapy. In these trials, patients receiving trilaciclib showed statistically significant improvements in duration and occurrence of severe neutropenia (primary endpoints) and clinically meaningful reductions in G-CSF administrations and red blood cell transfusions. Treatment was well tolerated and the safety profile of trilaciclib was consistent across the three trials.

Presented preliminary improved progression-free survival data from randomized Phase 2 trial of trilaciclib in combination with chemotherapy in patients with metastatic triple-negative breast cancer (mTNBC): In December, the company presented data from its Phase 2 trial of trilaciclib in patients with mTNBC at the 2018 San Antonio Breast Cancer Symposium. Preliminary median progression-free survival (PFS) was 5.4 months in the chemotherapy arm, 8.8 months in the chemotherapy and trilaciclib (dosed the day of chemotherapy) arm (hazard ratio 0.52, p=0.0669), and 7.3 months in the chemotherapy and trilaciclib (dosed the day prior to and day of chemotherapy) arm (hazard ratio 0.49; p=0.0546). A combined analysis of trilaciclib-treated patients showed PFS of 5.4 months for the chemotherapy arm and 7.9 months for chemotherapy and trilaciclib (hazard ratio 0.50, p=0.0189). Patients on trilaciclib received more chemotherapy cycles than those in the control arm. The safety profile of trilaciclib was consistent with previously reported trials; no trilaciclib-related serious adverse events were reported.

Anticipated Milestones for 2019

Meet with U.S. and European regulatory authorities in the first half of 2019 and announce the next steps for trilaciclib development in the second quarter of 2019.

Initiate additional randomized trials for trilaciclib in the second half of 2019, pending feedback from regulatory authorities.

Report additional data from all four randomized Phase 2 trilaciclib clinical trials.

Present additional data from the Phase 1b clinical trial of lerociclib/Faslodex (fulvestrant) in ER+, HER2- breast cancer in the second half of 2019.

Present preliminary dose-escalation data from the Phase 1b clinical trial of lerociclib/Tagrisso (osimertinib) in non-small cell lung cancer in the second half of 2019.

Present preliminary dose-escalation data from the Phase 1 clinical trial of G1T48, an oral selective estrogen receptor degrader (SERD), in ER+ breast cancer in the second half of 2019.

Fourth Quarter and Full-Year 2018 Financial Highlights

Cash Position: Cash, cash equivalents and short-term investments totaled $369.3 million as of December 31, 2018, compared to $390.5 million as of September 30, 2018, and $103.8 million as of December 31, 2017.

Operating Expenses: Operating expenses were $26.1 million for the fourth quarter of 2018, compared to $17.3 million for the fourth quarter of 2017. GAAP operating expenses include stock-based compensation expense of $3.3 million for the fourth quarter of 2018, compared to $1.0 million for the fourth quarter of 2017. Operating expenses for the full-year 2018 were $89.3 million, compared to $61.0 million for the prior year. Stock-based compensation expense for the full-year 2018 was $10.2 million, compared to $3.4 million for the prior year.

Research and Development Expenses: Research and development (R&D) expenses for the fourth quarter of 2018 were $19.1 million, compared to $15.1 million for the fourth quarter of 2017. The increase in expense was due to an increase in clinical program costs, drug manufacturing costs to support clinical programs, external research studies and personnel costs due to additional headcount. R&D expenses for the full-year 2018 were $70.7 million, compared to $53.9 million for the prior year.

General and Administrative Expenses: General and administrative (G&A) expenses for the fourth quarter of 2018 were $7.0 million, compared to $2.2 million for the fourth quarter of 2017. The increase in expense was largely due to an increase in professional fees and personnel-related costs. G&A expenses for the full-year 2018 were $18.6 million, compared to $7.1 million for the prior year.

Net Loss: G1 reported a net loss of $24.1 million for the fourth quarter of 2018, compared to $17.0 million for the fourth quarter of 2017. Net loss for the full-year 2018 was $85.3 million, compared to a net loss of $60.1 million for the prior year.

Webcast and Conference Call

The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a financial update for the fourth quarter and full-year of 2018. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 2698949. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

Clinical program updates will be provided at the Investor Day 2019 meeting on March 6.

On February 28, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will release its fourth quarter 2018 financial results on Thursday, March 7, after the close of the U.S. financial markets (Press release, Syndax, FEB 28, 2019, View Source [SID1234533815]).

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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 on Thursday, March 7, to discuss the Company’s financial results and provide a general business update.

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: 8252397
Domestic Dial-in Number: (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.