On February 28, 2019 Personalis, Inc., a leader in advanced genomics for precision oncology, reported that they are scheduled to present at the upcoming World Immunotherapy Congress USA, which is part of the Festival of Biologics USA, in San Diego on Tuesday, March 5, 2019 at 2:20 PM, PST (Press release, Personalis, FEB 28, 2019, View Source [SID1234533834]).

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The presentation, entitled "Comprehensive Immunogenomics for Biomarker Discovery from a Single Sample," will introduce Personalis’ new universal cancer immunogenomics platform, ImmunoID NeXT, and will discuss how this platform can be used to overcome the challenges facing immuno-oncology translational and clinical researchers to ultimately enable the development of safer, more effective precision oncology therapeutics and combinations.

ImmunoID NeXT is the first and only platform to provide comprehensive analysis of both a tumor and its microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology; consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Kedar Hastak, PhD, Field Application Scientist.

on February 28, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company dedicated to developing medicines for patients with B-cell mediated diseases, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, TG Therapeutics, FEB 28, 2019, View Source [SID1234533858]). The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. TG Therapeutics intends to grant the underwriter a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering. Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering.

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In addition, the Company announced that it has entered into a debt financing agreement for up to $60.0 million with Hercules Capital, Inc. (NYSE: HTGC), a leader in customizing debt financing for companies in the life sciences and technology-related markets. The first advance of $30.0 million was funded at closing. Two additional advances of $10.0 million may be drawn at the Company’s option, subject to certain clinical trial milestones, and the fourth advance of $10.0 million, is available through December 15, 2020 subject to the approval of Hercules.

The loan will mature on March 1, 2022. Payments under the loan are interest-only for a period of 18 months, followed by equal monthly installments of principal and interest thereafter. The interest-only period may be extended to 24 months contingent upon the Company achieving certain clinical development or fundraising milestones. In connection with the debt financing, the Company issued Hercules a warrant to purchase up to 147,058 of its common shares at an exercise price of $4.08 per share.

Further information with respect to the debt financing agreement with Hercules will be contained in a Current Report to be filed on Form 8-K by the Company with the Securities and Exchange Commission (the "SEC").

TG Therapeutics intends to use the net proceeds of the public offering and the debt facility to fund the ongoing development of ublituximab and umbralisib, for research and development activities and for general corporate purposes.

The public offering of common stock is being made pursuant to a shelf registration statement previously filed with the SEC on May 26, 2017 and declared effective by the SEC on June 13, 2017. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus related to the offering has been filed with the SEC and is available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus, when available, may also be obtained from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or 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 jurisdiction.

On February 28, 2019 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported the U.S. Food and Drug Administration (FDA) has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for subcutaneous (under the skin) injection for the treatment of certain people with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease (Press release, Genentech, FEB 28, 2019, View Source [SID1234533835]). This new treatment includes the same monoclonal antibody as intravenous Herceptin (trastuzumab) in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under the skin. Herceptin Hylecta is a ready-to-use formulation that can be administered in two to five minutes, compared to 30 to 90 minutes for intravenous Herceptin.

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"Over the past 20 years, Herceptin has significantly advanced treatment of HER2-positive breast cancer," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "The approval of Herceptin Hylecta gives physicians and patients in the United States a new option to select treatment based on individual needs and preferences."

The FDA approval is based on results from three clinical studies in HER2-positive early breast cancer:

The Phase III HannaH study compared neoadjuvant (before surgery) and adjuvant (after surgery) Herceptin Hylecta to intravenous Herceptin, both in combination with chemotherapy. Subcutaneous administration of Herceptin Hylecta resulted in non-inferior levels of trastuzumab in the blood (pharmacokinetics) and non-inferior clinical efficacy (pathological complete response rate; pCR) compared to intravenous Herceptin.
The Phase III SafeHER study of adjuvant Herceptin Hylecta identified no new safety signals, with safety and tolerability consistent with the known safety profiles of intravenous Herceptin and Herceptin Hylecta.
The PrefHER patient preference study of adjuvant Herceptin Hylecta followed by intravenous Herceptin, or the reverse sequence, found the majority (86 percent) of people preferred Herceptin Hylecta over intravenous Herceptin.
The most common side effects in people receiving Herceptin Hylecta for early breast cancer were feeling tired, joint pain, diarrhea, injection site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough and pain in extremity.

For those who qualify, Genentech offers patient assistance programs for people prescribed Herceptin Hylecta by their doctor through Genentech Access Solutions. Please contact Genentech Access Solutions at (866) 422-2377 or visit View Source for more information.

HannaH, SafeHER and PrefHER study results

HannaH
Herceptin Hylecta Intravenous Herceptin
pCR (absence of invasive cancer cells in the breast) 45.4% (118/260)
95% CI 39.2%-51.7%

40.7% (107/263)
95% CI 34.7%-46.9%

Mean level of trastuzumab in the blood (Ctrough) before dosing eighth cycle 78.7 mcg/mL 57.8 mcg/mL
Geometric mean ratio 1.3 (90% CI 1.2-1.4)
Most common adverse events (AEs; ≥10%)
Hair loss, nausea, administration-related reactions, feeling tired, decreased neutrophil count, diarrhea, rash, upper respiratory tract infection, vomiting, mouth blisters or sores, muscle pain, decreased appetite, constipation, radiation skin injury, damage to the nerves (numbness, tingling, pain in the hands/feet), joint pain, headache, flushing, fever, cough, low levels of red blood cells, difficulty breathing, incision site pain, low levels of white blood cells and, mucosal inflammation

SafeHER
Herceptin Hylecta
n=1,864

Safety No new safety signals for Herceptin Hylecta were identified. Safety and tolerability were consistent with the known safety profiles of intravenous Herceptin and Herceptin Hylecta.
Most common AEs (≥10%)
Administration-related reactions, feeling tired, diarrhea, injection site reaction, weakness, joint pain, rash, muscle pain, nausea, damage to the nerves (numbness, tingling, pain in the hands/feet), headache, swelling, flushing, fever, cough and pain in extremity

PrefHER
Herceptin Hylecta followed by intravenous Herceptin (n=121) or intravenous Herceptin followed by Herceptin Hylecta (n=119)
Patient preference 86% of people preferred Herceptin Hylecta, 13% preferred intravenous Herceptin, 1% had no preference
Reasons for preference The most common reason for preferring Herceptin Hylecta was time savings (179/231). The most common reason for preferring intravenous Herceptin was fewer local injection reactions.
About HER2-positive breast cancer

Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, approximately 271,000 people in the United States will be diagnosed with breast cancer, and more than 42,000 will die from the disease in 2019. Breast cancer is not one, but many diseases based on the biology of each tumor. In HER2-positive breast cancer, there is excess HER2 protein on the surface of tumor cells. Approximately 15-20 percent of breast cancers are HER2-positive based on the result of a diagnostic test.

About Herceptin Hylecta

Herceptin Hylecta (subcutaneous Herceptin) is a combination of trastuzumab and Halozyme Therapeutics’ Enhanze drug delivery technology. Trastuzumab is the same monoclonal antibody in intravenous Herceptin that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. Herceptin is designed to block HER2 signaling that is believed to play a role in tumor growth and survival. Binding of Herceptin to HER2 may also signal the body’s immune system to destroy the cancer cells. Halozyme’s Enhanze technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronan, a glycosaminoglycan or chain of natural sugars in the body, to aid in the dispersion and absorption of other injected therapeutic drugs.

Herceptin Hylecta Indication Statements

Adjuvant Breast Cancer

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) is approved for the treatment of adults with early stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2-positive) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin Hylecta can be used in several different ways:

As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as "AC→TH."
With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as "TCH."
Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy).
Patients are selected for therapy based on an FDA-approved test for trastuzumab.

*High risk is defined as ER/PR-positive with one of the following features: tumor size greater than 2 cm, age less than 35 years, or tumor grade 2 or 3.

Metastatic Breast Cancer

Herceptin Hylecta has two approved uses in adults with metastatic breast cancer:

Herceptin Hylecta in combination with the chemotherapy drug paclitaxel is approved for the first-line treatment of Human Epidermal growth factor Receptor 2-positive (HER2-positive) metastatic breast cancer.
Herceptin Hylecta alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease.
Patients are selected for therapy based on an FDA-approved test for trastuzumab.

Important Safety Information

Possible serious side effects with Herceptin Hylecta

Not all people have serious side effects, but side effects with Herceptin Hylecta therapy are common.

Although some people may have a life-threatening side effect, most do not.

A patient’s doctor will stop treatment if any serious side effects occur.

Herceptin Hylecta is not for everyone. A patient should be sure to contact their doctor if they are experiencing any of the following:

HEART PROBLEMS

These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both Herceptin Hylecta and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. A patient’s doctor will check for signs of heart problems before, during, and after treatment with Herceptin Hylecta.

Patients should contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than five pounds in 24 hours, dizziness or loss of consciousness.

SEVERE LUNG PROBLEMS, including:

Severe shortness of breath
Scarring of the lungs
Fluid in or around the lungs
Weakening of the valve between the heart and the lungs
Not enough oxygen in the body
Swelling of the lungs
A patient’s doctor may check for signs of severe lung problems when he or she examines the patient.

These signs usually happen within 24 hours after receiving Herceptin Hylecta.

A PATIENT SHOULD BE SURE TO CONTACT THEIR DOCTOR IF THEY:

ARE A WOMAN WHO COULD BECOME PREGNANT, OR MAY BE PREGNANT

Herceptin Hylecta may result in the death of an unborn baby or birth defects. Contraception should be used while receiving Herceptin Hylecta and for seven months after a patient’s last dose of Herceptin Hylecta. If a patient is or becomes pregnant while receiving Herceptin Hylecta or within seven months after their last dose of Herceptin Hylecta, the patient is encouraged to report Herceptin Hylecta exposure to Genentech at (888) 835-2555.

Have LOW WHITE BLOOD CELL COUNTS

Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving intravenous trastuzumab plus chemotherapy than in patients receiving chemotherapy alone.

A patient’s doctor may check for signs of low white blood cell counts when he or she examines the patient.

Experience HYPERSENSITIVITY AND ADMINISTRATION-RELATED REACTIONS, which have been reported with Herceptin Hylecta. Serious and fatal reactions have been reported after treatment with intravenous trastuzumab products. A patient’s doctor will monitor them for signs of these reactions. Patients should contact their healthcare provider immediately if they experience any symptoms of hypersensitivity and administration-related reactions, including dizziness, nausea, chills, fever, vomiting, diarrhea, hives, swelling under the skin, breathing problems or chest pain.

SIDE EFFECTS SEEN MOST OFTEN

The most common side effects seen in treatment of adjuvant breast cancer with Herceptin Hylecta were tiredness, joint pain, diarrhea, injection site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough and pain in extremity.

The most common side effects seen in treatment of metastatic breast cancer (based on intravenous trastuzumab) are fever, chills, headache, infection, congestive heart failure, insomnia, cough and rash.

A patient should contact their doctor immediately if they have any of the side effects listed above.

Patients are encouraged to report side effects to Genentech and the FDA. Report side effects to the FDA at (800) FDA-1088 or View Source Report side effects to Genentech at (888) 835-2555.

Please see the Herceptin Hylecta full Prescribing Information for additional Important Safety Information, including most serious side effects.

Herceptin Indication Statements

Adjuvant Breast Cancer

Herceptin is approved for the treatment of early stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2-positive) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin can be used in several different ways:

As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as "AC→TH."
With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as "TCH."
Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin) based therapy (a type of chemotherapy).
Patients are selected for therapy based on an FDA-approved test for Herceptin.

*High risk is defined as ER/PR-positive with one of the following features: tumor size greater than 2 cm, age less than 35 years, or tumor grade 2 or 3.

Metastatic Breast Cancer

Herceptin has two approved uses in metastatic breast cancer:

Herceptin in combination with the chemotherapy drug paclitaxel is approved for the first-line treatment of Human Epidermal growth factor Receptor 2-positive (HER2-positive) metastatic breast cancer.
Herceptin alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease.
Patients are selected for therapy based on an FDA-approved test for Herceptin.

Important Safety Information

Possible serious side effects with Herceptin

Not all people have serious side effects, but side effects with Herceptin therapy are common.

Although some people may have a life-threatening side effect, most do not.

A patient’s doctor will stop treatment if any serious side effects occur.

Herceptin is not for everyone. A patient should be sure to contact their doctor if they are experiencing any of the following:

HEART PROBLEMS

These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. A patient’s doctor will check for signs of heart problems before, during and after treatment with Herceptin.

INFUSION REACTIONS, including:

Fever and chills
Feeling sick to your stomach (nausea)
Throwing up (vomiting)
Pain (in some cases at tumor sites)
Headache
Dizziness
Shortness of breath
These signs usually happen within 24 hours after receiving Herceptin.

A patient should be sure to contact their doctor if they:

Are a woman who could become pregnant, or may be pregnant

Herceptin may result in the death of an unborn baby or birth defects. Contraception should be used while receiving Herceptin and for seven months after a patient’s last dose of Herceptin. If a patient is or becomes pregnant while receiving Herceptin or within seven months after their last dose of Herceptin, the patient should immediately report Herceptin exposure to Genentech at (888) 835-2555.

Have any signs of SEVERE LUNG PROBLEMS, including:

Severe shortness of breath
Fluid in or around the lungs
Weakening of the valve between the heart and the lungs
Not enough oxygen in the body
Swelling of the lungs
Scarring of the lungs
A patient’s doctor may check for signs of severe lung problems when he or she examines the patient.

Have LOW WHITE BLOOD CELL COUNTS

Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving Herceptin plus chemotherapy than in patients receiving chemotherapy alone.

A patient’s doctor may check for signs of low white blood cell counts when he or she examines the patient.

Side effects seen most often with Herceptin

Some patients receiving Herceptin for breast cancer had the following side effects:

Fever
Feeling sick to your stomach (nausea)
Throwing up (vomiting)
Infusion reactions
Diarrhea
Infections
Increased cough
Headache
Feeling tired
Shortness of breath
Rash
Low white and red blood cell counts
Muscle pain
A patient should contact their doctor immediately if they have any of the side effects listed above.

Patients are encouraged to report side effects to Genentech and the FDA. Report side effects to the FDA at (800) FDA-1088 or View Source Report side effects to Genentech at (888) 835-2555.

Please see the Herceptin full Prescribing Information for additional Important Safety Information, including most serious side effects, at View Source

About Genentech in breast cancer

Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have substantially improved outcomes for HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including triple-negative and hormone receptor-positive.

On February 28, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, reported financial results for the fourth quarter and full year ended December 31, 2018 and provided an overview of the Company’s recent developments (Press release, UroGen Pharma, FEB 28, 2019, View Source;p=RssLanding&cat=news&id=2389450 [SID1234533766]).

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"Our clinical and corporate execution in 2018 places UroGen in a position of strength as we prepare to potentially deliver UGN-101 as the first approved therapy for patients with low-grade upper tract urothelial cancer (LG UTUC)," said Liz Barrett, President and Chief Executive Officer of UroGen. "With this solid foundation, we remain intensely focused on finalizing our rolling New Drug Application (NDA) and accelerating commercial preparation to ensure a successful launch upon approval with seamless adoption of UGN-101. We believe UGN-101 is just the beginning of what may be possible with our proprietary RTGel technology platform."

"LG UTUC represents a clinical challenge as the current treatment of surgical intervention can put patients at risk for the well-known complications associated with repetitive surgical procedures and potential kidney removal," said Mark P. Schoenberg, M.D., Chief Medical Officer of UroGen. "If approved, UGN-101 could be a true breakthrough for patients by providing an option to avoid the risks and downstream consequences associated with surgery while arming urologists in general practice with a simple-to-use, kidney sparing approach to the management of their patient’s disease."

Recent Highlights

UGN-101 Clinical Development:

In the fourth quarter, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for UGN-101 (mitomycin gel) for instillation, an investigational mitomycin formulation for the non-surgical treatment of patients with LG UTUC.

In January 2019, the Company announced positive topline results from the pivotal Phase 3 OLYMPUS clinical trial of UGN-101, in which 57 percent of patients achieved a complete response (CR) rate at their primary disease evaluation (PDE, or the primary endpoint) which was conducted four to six weeks after completion of UGN-101 treatment.

Pipeline Advancement:

The Company continues to enroll patients as part of its Phase 2b OPTIMA II clinical trial of UGN-102 (mitomycin gel) for intravesical instillation as a potential first-line chemoablation agent in the treatment of intermediate risk patients with low-grade non-muscle invasive bladder cancer (LG NMIBC) at risk for recurrence.

Corporate Developments:

UroGen strengthened its leadership team with the appointment of Liz Barrett as President and Chief Executive Officer. Ms. Barrett has over 30 years of industry experience spanning multiple areas including oncology, specialty care, surgical franchises, and consumer marketing in multiple geographic regions, most recently serving as CEO of Novartis Oncology and as a member of the Executive Committee of Novartis.

The Company enhanced its financial position with the completion of a successful public offering of ordinary shares in January 2019, resulting in net proceeds of approximately $162 million. These proceeds leave the company well-capitalized to execute on upcoming milestones, including preparation for potential commercialization of UGN-101, continued clinical development of our second product candidate (UGN-102), and advancement of our pipeline.

Upcoming Milestones:

UGN-101: UroGen remains on track to complete its rolling NDA for UGN-101 in 2H 2019 and is planning for potential approval in 1H 2020. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.

The company continues to build out its commercial infrastructure and focus on scientific awareness to support adoption and seamless integration of UGN-101 into the urologist practice following potential regulatory approval.

UGN-102: The Company intends to report initial data from the OPTIMA II trial of UGN-102 in 2019.

Similar to UGN-101, UGN-102 has the potential to transform the treatment paradigm for patients with LG NMIBC, as there are currently no drugs approved by the FDA as first-line treatment for LG NMIBC.

UGN-102 represents a substantial opportunity in UroGen’s pipeline with the potential to initially address up to approximately 80,000 patients for whom repetitive surgical resection via Transurethral Resection of Bladder Tumor (TURBT) remains the standard of care.

BotuGel: Allergan continues to enroll patients in its Phase 2 trial of BotuGel, UroGen’s RTGel in combination with BOTOX1, for the treatment of overactive bladder. Phase 2 data is expected in 2019.

Fourth Quarter and Full Year 2018 Financial Results; 2019 Guidance

As of December 31, 2018, cash, cash equivalents, and short-term investments totaled $101.3 million. In addition, the Company raised net proceeds of approximately $162 million from an underwritten public offering in January 2019. Based on anticipated activities, the current cash balance is projected to carry the company for the next 24-36 months.

Research and development expenses for the year ended December 31, 2018 were $36.9 million, including non-cash share-based compensation expense of $12.0 million. Research and development expenses for the three months ended December 31, 2018 were $11.5 million, including non-cash share-based compensation expense of $3.0 million.

General and administrative expenses for the year ended December 31, 2018 were $39.6 million, including non-cash share-based compensation expense of $18.6 million. General and administrative expenses for the three months ended December 31, 2018 were $12.6 million, including non-cash share-based compensation expense of $5.9 million.

The Company reported a net loss of $75.7 million, or basic and diluted net loss per ordinary share of $4.80, for the year ended December 31, 2018. The Company reported a net loss of $23.7

BOTOX is a proprietary trademark of Allergan Pharmaceuticals

million, or basic and diluted net loss per ordinary share of $1.46, for the three months ended December 31, 2018.

The Company anticipates a net loss in the range of $100 to $115 million for 2019, which is expected to include non-cash stock-based compensation expense in the range of $24 to $27 million subject to market conditions. The projected change in net loss for 2019 versus 2018 is expected to be largely attributable to the buildout of commercial infrastructure in anticipation of the potential launch of UGN-101. The Company has 20.4 million ordinary shares outstanding post the closing of our most recent financing in January.

Conference Call & Webcast Information

Members of UroGen’s management team will host a live conference call and webcast today at 8:30 am Eastern Time to review the Company’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 771-4371 (U.S.) or (847) 585-4405 (International) to listen to the live conference call. The conference ID number for the live call will be 48205742. An archive of the webcast will be available for two weeks on the Company’s website.

On February 28, 2019 Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported financial results for the three-month period and year ended December 31, 2018 (Press release, Spectrum Pharmaceuticals, FEB 28, 2019, View Source [SID1234533836]).

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"2018 was a very productive year for Spectrum in which our two promising pipeline products significantly progressed in clinical development," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "We begin 2019 with great momentum after meeting the enrollment target for the first cohort in our pivotal poziotinib study and submitting the BLA for ROLONTIS to the FDA at the end of 2018. In 2019, we are laser-focused on continuing to develop our two late-stage products, poziotinib and ROLONTIS, and looking for new opportunities that build upon these assets."

Pipeline update:

Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations:

Enrollment in the EGFR, previously treated NSCLC cohort (cohort 1) in the ZENITH20 trial was completed; topline results are expected in Q4 2019.
Enrollment in the HER2, previously treated NSCLC cohort (cohort 2) in the ZENITH20 trial is expected to be completed in Q4 2019.
Initiation of pan-tumor and combination trials expected to be in H2 2019.
ROLONTIS (eflapegrastim), a novel long-acting GCSF:

Spectrum submitted the BLA with the FDA in late December 2018. Due to the government shutdown, the file was officially received on January 28, 2019.
Pipeline update continued:

Spectrum has begun launch readiness activities including inventory build and commercial preparedness.
Data from the Phase 3 study (RECOVER) was presented in a poster session at the San Antonio Breast Cancer Symposium in December 2018. The RECOVER study was the second pivotal trial to meet all primary and secondary endpoints and demonstrated comparable safety and tolerability profiles to pegfilgrastim.
2019 Guidance

Assuming the previously announced divestiture transaction closes in March, we expect 2019 SG&A costs to decrease by approximately 30 percent relative to 2018. We expect 2019 R&D costs to increase nominally as reduced spending on the legacy assets is offset by the increased spending on pre-commercial supply and tech transfer activities for ROLONTIS and poziotinib. With the increase of cash from the sale of our commercial assets, we expect our cash balance to be sufficient to fund operations for at least three years.

Three-Month Period Ended December 31, 2018 (All numbers are approximate)

GAAP Results

Total product sales were $28.0 million in the fourth quarter of 2018. Product sales in the fourth quarter included: FOLOTYN (pralatrexate injection) net sales of $12.2 million, EVOMELA (melphalan) for injection net sales of $7.5 million, BELEODAQ (belinostat) for injection net sales of $3.7 million, ZEVALIN (ibritumomab tiuxetan) net sales of $0.9 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $2.3 million, KHAPZORY (levoleucovorin) net sales of $0.9 million, and FUSILEV (levoleucovorin) net sales of $0.4 million.

Spectrum recorded net loss of $49.2 million, or $0.47 per basic and diluted share in the three-month period ended December 31, 2018, compared to net loss of $28.6 million, or $0.29 per basic and diluted share in the comparable period in 2017. Total research and development expenses were $34.5 million in the quarter, as compared to $22.1 million in the same period in 2017. Selling, general and administrative expenses were $23.3 million in the quarter, compared to $29.2 million in the same period in 2017.

The company ended the quarter with cash, cash equivalents and marketable securities of $204 million.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $32.1 million, or $0.30 per basic and diluted share in the three-month period ended December 31, 2018, compared to non-GAAP net loss of $22.8 million, or $0.23 per basic and diluted share in the comparable period in 2017. Non-GAAP research and development expenses were $33.6 million, as compared to $21.3 million in the same period of 2017. Non-GAAP selling, general and administrative expenses were $19.9 million, as compared to $19.1 million in the same period in 2017.

Twelve-Month Period Ended December 31, 2018 (All numbers are approximate)

GAAP Results

Total product sales were $104.5 million for the twelve months ended December 31, 2018. Total product sales decreased 10.1% from $116.2 million in the same period of 2017.

Product sales in 2018 included: FOLOTYN (pralatrexate injection) net sales of $48.0 million, EVOMELA (melphalan) for injection net sales of $28.3 million, BELEODAQ (belinostat) for injection net sales of $12.3 million, ZEVALIN (ibritumomab tiuxetan) net sales of $7.0 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $5.5 million, KHAPZORY (levoleucovorin) net sales of $0.9 million, and FUSILEV (levoleucovorin) net sales of $2.4 million. Spectrum recorded net loss of $120.0 million, or $1.16 per basic and diluted share in the twelve-month period ended December 31, 2018, compared to net loss of $91.2 million, or $1.07 per basic and diluted share in the comparable period in 2017. Total research and development expenses were $95.0 million for the year, as compared to $65.9 million in the same period in 2017. Selling, general and administrative expenses were $90.7 million for the year, compared to $84.3 million in the same period in 2017.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $86.8 million, or $0.84 per basic and diluted share in the twelve-month period ended December 31, 2018, compared to non-GAAP net loss of $52.1 million, or $0.61 per basic and diluted share in the comparable period in 2017. Non-GAAP research and development expenses were $91.0 million, as compared to $63.4 million in the same period of 2017. Non-GAAP selling, general and administrative expenses were $76.5 million, as compared to $65.4 million in the same period in 2017.

Conference Call

Thursday, February 28, 2019 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 2797623

International: (973) 796-5077, Conference ID# 2797623

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: View Source on February 28, 2019 at 4:30 p.m. Eastern/1:30 p.m. Pacific.