On May 9, 2018 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the Phase III IMblaze370 study evaluating the combination of TECENTRIQ (atezolizumab) and COTELLIC (cobimetinib) did not meet its primary endpoint of overall survival (OS) compared to regorafenib (Press release, Genentech, MAY 9, 2018, View Source [SID1234526404]). The study evaluated the combination in people with difficult-to-treat, locally advanced or metastatic colorectal cancer (CRC) whose disease progressed or who were intolerant to at least two systemic chemotherapy regimens.

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More than 95 percent of patients in IMblaze370 have microsatellite stable (MSS) tumors and based on the available data, checkpoint inhibitors as monotherapy have not demonstrated clinically meaningful efficacy in MSS mCRC. The results from IMblaze370 were consistent with this prior monotherapy experience, showing that treatment with TECENTRIQ alone did not provide a meaningful clinical benefit compared to regorafenib in this patient population.

Safety for the combination of TECENTRIQ and COTELLIC appeared to be consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. The results from IMblaze370 will be further examined and presented at an upcoming medical meeting.

"While these results are not what we hoped for, we remain committed to applying our deep experience to develop medicines that will improve outcomes for people living with gastrointestinal cancers," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "In particular, we have a number of studies evaluating medicines in colorectal cancer that could play an important role in the treatment of people with this disease in the future."

Genentech has an extensive clinical trial development program for TECENTRIQ, with more than 50 studies ongoing, including multiple Phase III studies across lung, kidney, skin, breast, colorectal, prostate, ovarian, bladder, blood, liver and head and neck cancers. This includes studies evaluating TECENTRIQ both alone and in combination with other medicines.

About the IMblaze370 study

IMblaze370 is a Phase III, multi-center, open-label, three-arm, randomized study in people with difficult-to-treat locally advanced or metastatic colorectal cancer who have received at least two prior regimens of chemotherapy for metastatic disease. The study compares regorafenib, a standard of care therapy in this setting, to COTELLIC plus TECENTRIQ and TECENTRIQ monotherapy. The study enrolled 363 people who were randomized (2:1:1) to receive:

TECENTRIQ plus COTELLIC, or
TECENTRIQ, or
Regorafenib (control arm)
People in the combination arm received COTELLIC on days 1 to 21 plus TECENTRIQ on day 1 and day 15 in a 28-day cycle, until loss of clinical benefit. People in the monotherapy arm received TECENTRIQ on day 1 of each 21-day cycle, until loss of clinical benefit. People in the control arm received regorafenib on days 1 to 21 in a 28-day cycle, until loss of clinical benefit. The primary endpoint was overall survival. Key secondary endpoints include progression-free survival (PFS), overall response rate (ORR) and duration of response (DoR).

About colorectal cancer

According to the American Cancer Society, colorectal cancer (CRC) is the third most commonly diagnosed cancer in both men and women in the United States and the third leading cause of cancer deaths. In 2018, an estimated 97,000 people will be diagnosed with colorectal cancer and about 50,000 people are expected to die from the disease in the United States. If colorectal cancer spreads (metastasizes) to distant organs, such as the lungs or the liver, five-year survival is 14 percent.

About the TECENTRIQ (atezolizumab) and COTELLIC (cobimetinib) combination

Based on our pre-clinical data and Phase Ib data there was a strong scientific rationale to support the further investigation of TECENTRIQ and COTELLIC. The IMblaze370 data will be further examined in order to better understand the results and presented at an upcoming medical meeting. Genentech is continuing to investigate the TECENTRIQ and COTELLIC combination in other tumor types, including the IMspire150 and IMspire170 studies in melanoma.

About TECENTRIQ (atezolizumab)

TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1. TECENTRIQ is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the re-activation of T cells. TECENTRIQ may also affect normal cells.

About COTELLIC (cobimetinib)

COTELLIC is a prescription medicine used with Zelboraf for the treatment of people with a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal BRAF gene. COTELLIC is not used to treat melanoma with a normal BRAF gene. COTELLIC was discovered by Exelixis Inc. and was developed by Genentech in collaboration with Exelixis. COTELLIC is also being investigated in combination with several investigational medicines, including TECENTRIQ, in several tumor types such as non-small cell lung cancer, melanoma and colorectal cancer.

TECENTRIQ U.S. Indication (pronounced ‘tē-SEN-trik’)

TECENTRIQ is a prescription medicine used to treat:

a type of bladder and urinary tract cancer called urothelial carcinoma.

TECENTRIQ may be used when your bladder cancer:
has spread or cannot be removed by surgery, and
you are not able to take chemotherapy that contains a medicine called cisplatin, or
you have tried chemotherapy that contains platinum, and it did not work or is no longer working
The approval of TECENTRIQ in these patients is based on a study that measured response rate and duration of response. There is an ongoing study to confirm clinical benefit.

A type of lung cancer called non-small cell lung cancer (NSCLC).

TECENTRIQ may be used when your lung cancer:
has spread or grown, and
you have tried chemotherapy that contains platinum, and it did not work or is no longer working
If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.

It is not known if TECENTRIQ is safe and effective in children.

Important Safety Information

What is the most important information about TECENTRIQ?

TECENTRIQ can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life threatening and can lead to death.

Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.

TECENTRIQ can cause serious side effects, including:

Lung problems (pneumonitis) –signs and symptoms may include new or worsening cough, shortness of breath, and chest pain
Liver problems (hepatitis) –signs and symptoms of hepatitis may include yellowing of the skin or the whites of the eyes, severe nausea or vomiting, pain on the right side of the stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual
Intestinal problems (colitis) –signs and symptoms of colitis may include diarrhea (loose stools) or more bowel movements than usual, blood or mucous in the stools or dark, tarry, sticky stools, and severe stomach area (abdomen) pain or tenderness
Hormone gland problems (especially the thyroid, adrenal glands, pancreas, and pituitary) –signs and symptoms that the hormone glands are not working properly may include headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior (such as decreased sex drive, irritability, or forgetfulness), feeling cold, constipation, the voice gets deeper, urinating more often than usual, nausea or vomiting, and stomach area (abdomen) pain
Problems in other organs –signs and symptoms may include severe muscle weakness, numbness or tingling in hands or feet, confusion, blurry vision, double vision, or other vision problems, changes in mood or behavior, extreme sensitivity to light, neck stiffness, eye pain or redness, skin blisters or peeling, chest pain, irregular heartbeat, shortness of breath, or swelling of the ankles
Severe infections –signs and symptoms of infection may include fever, cough, flu-like symptoms, pain when urinating, and frequent urination or back pain
Severe infusion reactions –signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, swelling of the face or lips, dizziness, fever, feeling like passing out, and back or neck pain
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with TECENTRIQ if patients have severe side effects.

Before receiving TECENTRIQ, patients should tell their healthcare provider about all of their medical conditions, including if they:

have immune system problems (such as Crohn’s disease, ulcerative colitis, or lupus); have had an organ transplant; have lung or breathing problems; have liver problems; have a condition that affects the nervous system (such as myasthenia gravis or Guillain-Barre syndrome); or are being treated for an infection
are pregnant or plan to become pregnant. TECENTRIQ can harm an unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TECENTRIQ. If you are able to become pregnant:
your healthcare provider should do a pregnancy test before you start treatment with TECENTRIQ
You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of TECENTRIQ
are breastfeeding or plan to breastfeed. It is not known if TECENTRIQ passes into the breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of TECENTRIQ
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of TECENTRIQ in people with urothelial carcinoma include:

feeling tired
decreased appetite
nausea
constipation
urinary tract infection
diarrhea
fever
The most common side effects of TECENTRIQ in people with non-small cell lung cancer include:

feeling tired
decreased appetite
muscle pain
cough
shortness of breath
TECENTRIQ may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if you have concerns about fertility.

These are not all the possible side effects of TECENTRIQ. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects.

Report side effects to the FDA at 1-800-FDA-1088 or View Source Report side effect to Genentech at 1-888-835-2555.

Please visit View Source for the TECENTRIQ full Prescribing Information for additional Important Safety Information.

Cotellic U.S. Indication

Cotellic is a prescription medicine that is used with the medicine Zelboraf to treat a type of skin cancer called melanoma:

that has spread to other parts of the body or cannot be removed by surgery, and
that has a certain type of abnormal "BRAF" gene.
A patient’s healthcare provider will perform a test to make sure that Cotellic is right for the patient. It is not known if Cotellic is safe and effective in children under 18 years of age.

Important Safety Information

Before taking Cotellic, patients should tell their healthcare provider about all of their medical conditions, including if they:

have skin problems or history of skin problems, other than melanoma
have bleeding problems, any medical conditions and/or on any medications that increase the risk of bleeding
have heart problems
have eye problems
have liver problems
have muscle problems
are pregnant or plan to become pregnant. Cotellic can harm an unborn baby.
Females who are able to become pregnant should use effective birth control during treatment with Cotellic, and for two weeks after the final dose of Cotellic.
Patients should talk to their healthcare provider about birth control methods that may be right for them.
Patients should tell their healthcare provider right away if they become pregnant or think they are pregnant during treatment with Cotellic.
are breastfeeding or plan to breastfeed. It is not known if Cotellic passes into breast milk. Patients should not breastfeed during treatment with Cotellic and for two weeks after the final dose of Cotellic. Patients should talk to their healthcare provider about the best way to feed their baby during this time.
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Certain medicines may affect the blood levels of Cotellic.

Patients should know the medicines they take and keep a list of them to show their healthcare provider and pharmacist when they get a new medicine.

How should patients take Cotellic?

Patients should take Cotellic exactly as their healthcare provider tells them. Patients should not change their dose or stop taking Cotellic unless their healthcare provider tells them to.
Patients should take Cotellic one time a day for 21 days, followed by seven days off treatment, to complete a 28-day treatment cycle.
Patients can take Cotellic with or without food.
If a patient vomits after taking their dose of Cotellic, they should not take an additional dose.
If a patient misses a dose of Cotellic, they should take their next dose as scheduled.
What should patients avoid during treatment with Cotellic?

Patients should avoid sunlight during treatment with Cotellic. Cotellic can make a patient’s skin sensitive to sunlight. They may burn more easily and get severe sunburns. To help protect against sunburn:

When a patient goes outside, they should wear clothes that protect their skin, including their head, face, hands, arms and legs.
They should use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.
What are the possible side effects of Cotellic?

Cotellic may cause serious side effects, including:

Risk of new skin cancers. Cotellic may cause new skin cancers (cutaneous squamous cell carcinoma, keratoacanthoma or basal cell carcinoma).
Patients should check their skin regularly and tell their healthcare provider right away if they have any skin changes including:

new wart
skin sore or reddish bump that bleeds or does not heal
change in size or color of a mole
A patient’s healthcare provider should check the patient’s skin before they start taking Cotellic, and every two months during treatment with Cotellic. A patient’s healthcare provider may continue to check the patient’s skin for six months after the patient stops taking Cotellic.

A patient’s healthcare provider should also check for cancers that may not occur on the skin. Patients should tell their healthcare provider about any new symptoms that develop during treatment with Cotellic.

Bleeding problems. Cotellic can cause serious bleeding problems.
Patients should call their healthcare provider and get medical attention right away if they get any signs of bleeding, including:

red or black stools (looks like tar)
blood in their urine
headaches
cough up or vomit blood
stomach (abdominal) pain
unusual vaginal bleeding
dizziness or weakness

Heart problems . A patient’s healthcare provider should do tests before and during treatment to check the patient’s heart function. Patients should tell their healthcare provider if they get any of these signs and symptoms of heart problems:
persistent coughing or wheezing
shortness of breath
swelling of their ankles and feet
tiredness
increased heart rate
Severe rash. Patients should tell their healthcare provider right away if they get any of these symptoms:
a rash that covers a large area of their body
blisters
peeling skin
Eye problems. Patients should tell their healthcare provider right away if they get any of these symptoms:
blurred vision
partly missing vision or loss of vision
see halos
any other vision changes
A patient’s healthcare provider should check the patient’s eyes if the patient notices any of the symptoms above.

Liver problems. A patient’s healthcare provider should do blood tests to check the patient’s liver function before and during treatment. Patients should tell their healthcare provider right away if they get any of these symptoms:
yellowing of their skin or the white of their eyes
dark or brown (tea color) urine
nausea or vomiting
feeling tired or weak
loss of appetite
Muscle problems (rhabdomyolysis). Cotellic can cause muscle problems that can be severe. Treatment with Cotellic may increase the level of an enzyme in the blood called creatine phosphokinase (CPK) and may be a sign of muscle damage. A patient’s healthcare provider should do a blood test to check the patient’s levels of CPK before and during treatment. Patients should tell their healthcare provider right away if they get any of these symptoms:
muscle aches or pain
muscle spasms and weakness
dark, reddish urine
Skin sensitivity to sunlight (photosensitivity). Skin sensitivity to sunlight during treatment with Cotellic is common and can sometimes be severe. Patients should tell their healthcare provider if they get any of these symptoms:
red, painful, itchy skin that is hot to touch
sun rash
skin irritation
bumps or tiny papules
thickened, dry, wrinkled skin
See "What should patients avoid during treatment with Cotellic?" for information on protecting the skin during treatment with Cotellic.

The most common side effects of Cotellic include:

diarrhea
nausea
fever
vomiting
A patient’s healthcare provider will take blood tests during treatment with Cotellic. The most common changes to blood tests include:

increased blood levels of liver enzymes (GGT, ALT or AST)
increased blood level of enzyme from muscle (creatine phosphokinase)
decreased blood level of phosphate, sodium or potassium
increased blood level of liver or bone enzyme (alkaline phosphatase)
decreased blood level of a type of white blood cell (lymphocyte)
These are not all the possible side effects of Cotellic. Patients should call their doctor for medical advice about side effects. Patients may report side effects to FDA at (800) FDA-1088 or View Source Patients may also report side effects to Genentech at (888) 835-2555.

Please see Full Cotellic Prescribing Information and Patient Information for additional Important Safety Information at View Source

About Genentech in Personalized Cancer Immunotherapy

For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer. The goal of PCI is to provide each person with a treatment tailored to harness his or her own immune system to fight cancer. Genentech is studying more than 20 investigational medicines, 10 of which are in clinical trials. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visit View Source

On May 9, 2018 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, today reported first quarter 2018 financial results (Press release, CytomX Therapeutics, MAY 9, 2018, View Source [SID1234527066]).

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As of March 31, 2018, CytomX had cash, cash equivalents and short-term investments of $361.5 million.

"CytomX’s first quarter marked the continued execution across our clinical pipeline, our discovery stage programs and in our partnerships," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "We remain on track to share initial Probody clinical data at ASCO (Free ASCO Whitepaper) from PROCLAIM-CX-072, a broad-based study of our lead and wholly-owned anti-PD-L1 Probody therapeutic and we look forward to providing additional pipeline updates as the year progresses."

Business Highlights and Recent Developments

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

CX-072 is a Probody therapeutic targeting PD-L1, a clinically- and commercially-validated anti-cancer target.
Initial clinical data from the Phase 1/2 PROCLAIM-CX-072 program will be presented on Monday June 4, from 8:00 – 11:30 a.m. as part of the Developmental Therapeutics—Immunotherapy session at the ASCO (Free ASCO Whitepaper) Annual Meeting.
Abstract 3071 – Preliminary Results of the First-In-Human, Dose-Finding PROCLAIM-072 Trial of the PD-L1 Probody Therapeutic CX-072 as Monotherapy in Patients with Advanced Solid Tumors
Abstract 3072 – Preliminary Interim Results of the First-In-Human, Dose-Finding PROCLAIM-072 Trial of the PD-L1 Probody Therapeutic CX-072 in Combination with Ipilimumab in Patients with Advanced Solid Tumors
The data presented at the meeting will reflect a data cutoff approximately five months later than the abstract submission data cutoff, and therefore, will include longer term follow up as well data from additional patients.
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program

CX-2009 is a Probody drug conjugate (PDC) that targets CD166, an antigen that is broadly and highly expressed in many types of cancer.
Preliminary data from Part A of the PROCLAIM-CX-2009 Phase 1/2 clinical program is expected to be presented in the second half of 2018.
CX-2029 (CD71 Probody Drug Conjugate) Preclinical Program

CytomX, in collaboration with AbbVie, is advancing CX-2029, a CD71-directed PDC.
CytomX filed an Investigational New Drug (IND) application for CX-2029 in April 2018.
CytomX expects the initiation of clinical trials in the third quarter of 2018.
CX-188 (PD-1 Probody Therapeutic) Preclinical Program

CytomX is advancing CX-188, a PD-1-directed Probody therapeutic, through IND-enabling studies.
CytomX expects to file an IND application for CX-188 in the second half of 2018.
First Quarter 2018 Financial Results
Cash, cash equivalents and short-term investments totaled $361.5 million as of March 31, 2018, compared to $374.1 million as of December 31, 2017.

Revenue was $14.2 million for the three months ended March 31, 2018, compared to $11.7 million for the three months ended March 31, 2017. The increase was primarily attributable to an increase of $4.9 million relating to the recognition of $6.3 million of the upfront payment received from BMS in connection with an amendment of the Company’s Collaboration and License Agreement entered into in March 2017, offset by $1.2 million in revenue recognized resulting from a reduction in research terms during the three months ended March 31, 2017; an increase of $1.3 million resulting from a change in revenue recognition for the Company’s CD71 Agreement with AbbVie from the straight-line method under the prior revenue recognition standard to the percentage-of-completion method under the new revenue recognition standard, which the Company adopted on January 1, 2018; an increase of $1.3 million related to the Amgen Agreement, which the Company entered into at the end of September 2017; and an increase of $0.9 million resulting primarily from the recognition of the remaining upfront payments resulting from the termination of the Company’s agreement with Pfizer in March 2018. These increases were offset by a decrease of $5.8 million related to ImmunoGen due primarily to the recognition of $6.5 million upon delivery of a Development and Commercialization License to ImmunoGen during the three months ended March 31, 2017.

Research and development expenses increased $7.9 million during the three months ended March 31, 2018 compared to the corresponding period in 2017. The increase was attributable to an increase of $3.5 million in lab contracts and services, consulting expenses and clinical trial startup fees to advance CX-188 and CX-2029 through IND-enabling studies, an increase of $2.2 million in CX-072 resulting from increased clinical trial activities, and an increase of $2.0 million in personnel-related expenses due to an increase in headcount.

General and administrative expense increased $1.7 million during the three months ended March 31, 2018 compared to the corresponding period in 2017. The increase was attributable to an increase of $0.8 million in personnel-related expense due to an increase in headcount, an increase of $0.4 million in stock-based compensation resulting from an increase in headcount and an increase in the average price of the Company’s common stock and an increase of $0.4 million in consulting services primarily due to an increase in tax and accounting compliance activities.

On May 9, 2018 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported its financial results for the three months ended March 31, 2018 and provided a corporate update (Press release, Protalix, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348043 [SID1234526319]).

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"We continue to execute against our upcoming milestones, including the completion of enrollment in our phase III clinical trials of PRX-102 and exploring potential partnering opportunities for our clinical assets," said Moshe Manor, Protalix’s President and Chief Executive Officer. "We reported positive results for OPRX-106 in the first quarter of this year, which not only demonstrate the drug’s potential in the treatment of ulcerative colitis, but also highlight the potential of our ProCellEx platform technology to deliver biologics orally."

2018 First Quarter and Recent Clinical Highlights

Continued enrollment in the three Phase III trials, the BALANCE, BRIDGE and BRIGHT studies, for pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease at nearly 50 clinical trial sites worldwide.
Testing of blood samples from certain patients screened for the BALANCE study were analyzed for anti-drug antibody (ADA) presence and neutralizing activity, and the cross-reactivity and inhibition of such antibodies to PRX-102. A description of the data from the analysis has been accepted as a poster presentation scheduled on May 25, 2018 at the 55th ERA-EDTA Congress (European Renal Association – European Dialysis and Transplant Association) being held in Copenhagen, Denmark, May 24-27, 2018.
Reported positive top-line clinical results for the Company’s OPRX-106 phase IIa clinical trial in ulcerative colitis patients.
Oral presentation detailing the results from the Company’s phase IIa clinical trial of OPRX-106 for the treatment of ulcerative colitis accepted for the Digestive Disease Week (DDW) 2018 Annual Meeting in Washington, D.C., June 2-5, 2018.
The presentation at the DDW will include new clinical data and detailed per patient results further supporting the consistent effect in patients.
Financial Results for Three Months ended March 31, 2018

The Company reported a net loss of $9.4 million, or $0.06 per share, basic and diluted for the three-month period ended March 31, 2018 compared to a net loss of $8.4 million, or $0.07 per share, basic and diluted, excluding a one-time, non-cash charge of $52.3 million in connection with the remeasurement of a derivative, for the three-month period ended March 31, 2017.
The Company recorded total revenues of $4.6 million for the three-month period ended March 31, 2018, compared to $2.9 million for the same period of 2017. The increase is attributed mainly to increased sales of alfataliglicerase in Brazil.
Research and development expenses were $7.3 million for the three-month period ended March 31, 2018, compared to $6.0 million for the same period of 2017. The increase is mainly due to the advanced stages of the Company’s clinical trials of its drug candidates.
Selling, general and administrative expenses were $2.5 million for the three-month period ended March 31, 2018 and March 31, 2017.
As of March 31, 2018, the Company had $41.3 million of cash and cash equivalents.
Conference Call and Webcast Information

The Company will host a conference call on Wednesday, May 9, 2018, at 8:30 am ET to review the clinical, corporate and financial highlights.

To participate in the conference call, please dial the following numbers prior to the start of the call: United States: +1-844-358-6760; International: +1-478-219-0004. Conference ID number 8190507.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

On May 9, 2018 Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics, will present at the Bank of America Merrill Lynch 2018 Healthcare Conference on Wednesday, May 16, 2018, at 1:00 p.m. PDT at the Encore Hotel in Las Vegas, NV (Press release, Heron Therapeutics, MAY 9, 2018, View Source [SID1234526369]).

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A live webcast of this presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

On May 9, 2018 Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) reported financial results for the three months ended March 31, 2018 and provided a corporate update (Press release, Portola Pharmaceuticals, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348250 [SID1234526385]).

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"We achieved several major manufacturing and regulatory milestones this past year, including last week’s U.S. approval of Andexxa. We are now concentrating the Company’s efforts on the successful launch of Andexxa and Bevyxxa, which both have the potential to impact public health and become standards of care in the field of thrombosis," said Bill Lis, chief executive officer of Portola. "We are also encouraged by interim data for our next compound for hematologic cancers, cerdulatinib, which will be presented next month at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Together, these three compounds comprise a leading thrombosis and hematology portfolio, all with global rights."

Recent Achievements, Upcoming Events and Milestones

Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo] – antidote for the reversal of the Factor Xa inhibitors rivaroxaban and apixaban.

Andexxa received Accelerated Approval from the FDA on May 3, 2018 for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Earned an additional $100 million milestone payment from the Company’s royalty-based financing with Health Care Royalty Partners based on the FDA approval of Andexxa in May 2018.
Early Supply Program to launch in June with broader commercial launch anticipated in early 2019, upon FDA approval of the Generation 2 product.
Presented interim data from the ongoing Phase 3b/4 ANNEXA-4 study in a late-breaking clinical trial presentation at the American College of Cardiology’s 67th Annual Scientific Session & Expo (ACC.18). Enrollment on track for completion this summer.
Received a positive CHMP trend vote and working with regulatory authorities to address their accompanying request for additional data.
Built significant Generation 2 product inventory to meet broad demand upon regulatory approval in the U.S. and Europe.
Bevyxxa (betrixaban) – oral, once-daily Factor Xa inhibitor approved for extended prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.

Initiated U.S. commercial launch and continued to expand the field force and market access teams.
Additional results from the APEX trial published in the American Heart Journal and the American Journal of Medicine continue to highlight betrixaban’s effect on symptomatic VTE and VTE-related deaths.
Eight abstracts accepted at the upcoming International Society on Thrombosis and Haemostasis (ISTH) and European Society of Cardiology (ESC) meetings.
Cerdulatinib – an oral, dual-spleen tyrosine kinase (SYK) and janus kinase (JAK) inhibitor in development for the treatment of relapsed/refractory B-cell and other T-cell malignancies in patients who have failed multiple therapies.

Completed enrollment in two of four cohorts of the ongoing Phase 2a study evaluating the safety and efficacy of cerdulatinib in patients with relapsed/refractory B-cell and T-cell malignancies who have failed multiple therapies.
Interim results from the ongoing Phase 2a study accepted for presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Received initial feedback from the FDA on the potential regulatory pathway.
First Quarter 2018 Financial Results
Total revenue for the first quarter of 2018 was $6.6 million, compared with $5.1 million for the first quarter of 2017. This includes $6.0 million in collaboration and license revenue earned under Portola’s collaboration and license agreements with Bristol-Myers Squibb Company, Pfizer, Bayer Pharma, Janssen Pharmaceuticals and Daiichi Sankyo, as well as $0.6 million in product revenue from initial sales of Bevyxxa, which was launched in the U.S. in January 2018.

Total operating expenses for the first quarter of 2018 were $91.9 million, compared with $45.7 million for the same period in 2017. Total operating expenses for the first quarter of 2018 included $11.0 million in stock-based compensation expense, compared with $9.0 million for the same period in 2017.

Research and development expenses were $60.1 million for the first quarter of 2018, compared with $30.6 million for the first quarter of 2017. The increase is due to the second Generation 2 commercial manufacturing campaign. Selling, general and administrative expenses for the first quarter of 2018 were $31.5 million, compared with $15.0 million for the same period in 2017. The increase is due to the build-out of the field force and marketing spend for the Bevyxxa launch.

For the first quarter of 2018, Portola reported a net loss of $84.2 million, or $1.28 net loss per share, compared with a net loss of $41.7 million, or $0.74 net loss per share, for the same period in 2017. Shares used to compute net loss per share attributable to common stockholders were 65.5 million for the first quarter of 2018 compared with 56.7 million for the same period in 2017.

Cash, cash equivalents and investments at March 31, 2018 totaled $451.1 million, compared with cash, cash equivalents and investments of $534.2 million as of December 31, 2017.

Based on the FDA approval of Andexxa in May 2018, the Company earned an additional $100 million milestone payment from its royalty-based financing with Health Care Royalty Partners.

Conference Call Details
Portola will host a conference call today, Wednesday, May 9, 2018, at 4:30 p.m. ET, during which time management will provide first quarter 2018 financial results, updates on Andexxa, the U.S. launch of Bevyxxa and other matters. The live call can be accessed by phone by dialing (844) 452-6828 from the U.S. and Canada or 1 (765) 507-2588 internationally and using the passcode 7068059. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.