On May 9, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies1, provided corporate updates and reported financial results for the first quarter of 2019 (Press release, Agenus, MAY 9, 2019, View Source [SID1234536002]).

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"2019 is off to a strong start. We have made significant progress towards our efforts to bring transformative treatments to cancer patients." said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "In the first quarter of this year, we have strengthened our balance sheet, accelerated enrollment in our BLA path trials, and started a new clinical trial with our second generation CTLA4."

Achievements
Strengthened balance sheet
Closed on our collaboration with Gilead, which included $120M upfront, $30M equity investment and up to $1.7B in potential additional fees and milestone payments plus royalties
Received $7.5 million from Gilead as milestone payment for IND acceptance of AGEN1423 (now GS-1423), by the FDA
Enrollment in lead trials progressing; On track for BLA in 2020
Ongoing trials in cervical cancer are designed to support BLA via accelerated pathway
We plan to expand PD-1 development in additional indications through novel funding mechanisms
Enrollment proceeding in next-gen CTLA-4 trial
Started first-in-human trial with our next-gen CTLA4.
Enrollment advancing, and combinations and data expected this year
Advanced new discoveries, towards the clinic
First-in-class bispecific licensed to Gilead, GS-1423 IND accepted by the FDA
On track to file an IND for a CD137 agonist and an off-the shelf phosphorylated neoantigen vaccine
QS-21 Updates
Sales of Shingrix, containing our QS-21 Stimulon, continue to increase; GSK projects 2019 sales will exceed $1.3Bn and pledged $100M investment to expand production of its adjuvant system
A large-scale trial with QS-21 containing Mosquirix vaccine against malaria, began in Africa
AgenTus Cell Therapy Business:
2019 INDs are on track
Partnership and private financing discussions are underway
First Quarter 2019 Financial Results

We ended the first quarter of 2019 with a cash balance of $158 million as compared to $53 million at December 31, 2018.

For the first quarter ended March 31, 2019, we reported net income of $17 million or $0.14 per share compared to a net loss for same period in 2018 of $54 million, or $0.53 per share. In the first quarter we recognized revenue of $80 million which includes revenue from our transaction with Gilead and non-cash royalties earned.

Conference Call, Webcast and Prepared Statement Information

Date: Thursday, May 9, 2019
Time: 8:30 a.m. ET
Domestic Dial-in Number: (866) 682-6100
International Dial-in Number: (862) 298-0702
Conference ID: Agenus

Live Webcast: accessible from the Company’s website at View Source or with this link View Source

A replay will be available on the Company’s website approximately two hours after the call and will remain available for 90 days.

On May 9, 2019 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company," "We" or "Sophiris"), a biopharmaceutical company developing topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, reported financial results for the first quarter of 2019 (Press release, Sophiris Bio, MAY 9, 2019, View Source [SID1234536042]).

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"We continue to have dialog with the European Medicines Agency (EMA) regarding the design for a potential Phase 3 clinical trial, which we developed with input from our scientific advisory board for the treatment of localized prostate cancer," said Randall E. Woods, president and CEO of Sophiris. "We anticipate obtaining formal scientific advice from the EMA before the end of the second quarter and look forward to taking the next step in the clinical development of topsalysin for the focal treatment of localized prostate cancer before the end of the year. We have cash runway to continue operations into September and believe that the ideal funding option for a potential registration Phase 3 clinical trial will either be a potential development partnership or other strategic transaction."

Financial Results:

At March 31, 2019, the Company had cash, cash equivalents and securities available-for-sale of $9.0 million and working capital of $4.7 million. The Company expects that its cash and cash equivalents and securities available-for-sale will be sufficient to fund its operations through September 2019, assuming no new clinical trials are initiated and the Company continues operating as a going concern. The Company will require significant funding to advance topsalysin in clinical development. As of March 31, 2019, the outstanding principal balance of the Company’s term loan was $7.0 million. The Company began making principal payments on its term loan in April 2019.

The Company reported a net loss of $2.4 million or ($0.08) per share for the three months ended March 31, 2019, compared to net loss of $3.3 million or ($0.11) per share for the three months ended March 31, 2018.

Research and development expenses

Research and development expenses were $1.6 million for the three months ended March 31, 2019, compared to $3.3 million for the three months ended March 31, 2018. The decrease in research and development costs is primarily attributable to decreases in the costs associated with manufacturing activities for topsalysin, and to a lesser extent, a decrease in clinical costs associated with our Phase 2b clinical trial of topsalysin for localized prostate cancer. Included in the research and development costs for the three months ended March 31, 2019, were costs associated with the completion of a fill finish campaign at commercial scale which produced drug product for future clinical trials. Analysis for release of this recently filled drug product is underway.

General and administrative expenses

General and administrative expenses were $1.3 million for the three months ended March 31, 2019, compared to $1.2 million for the three months ended March 31, 2018.

Gain on revaluation of the warrant liability

Gain on revaluation of the warrant liability was $0.6 million for the three months ended March 31, 2019, compared to $1.4 million for the three months ended March 31, 2018. As the Company’s warrants may require the Company to pay the warrant holder cash under certain provisions of the warrant, the Company accounts for the warrants as a liability, and the Company is required to calculate the fair value of these warrants each reporting date. Certain inputs utilized in the Company’s Black-Scholes fair value calculation may fluctuate in future periods based upon factors which are outside of the Company’s control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change to the fair value of the Company’s warrant liability, which could also result in a material non-cash gain or loss being reported in the Company’s consolidated statement of operations and comprehensive loss.

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On May 9, 2019 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported financial results for the first quarter of 2019 (Press release, Immunomedics, MAY 9, 2019, View Source [SID1234536076]). Please refer to the Company’s Quarterly Report on Form 10-Q for more details on the Company’s financial results.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We have made meaningful progress in all business areas during the past three months. Significantly, we have received clarity from the FDA on the CRL and plan to resubmit the BLA in early fourth quarter of 2019. In the meantime, our salesforce is working closely with Janssen Biotech Inc. to co-promote Balversa, allowing our team to further build on its extensive experience in the oncology community. To enhance shareholder value and to continue on our path to becoming a global biopharmaceutical company, we are partnering with China-based Everest Medicines to develop and commercialize sacituzumab govitecan in Greater China, the world’s fastest growing pharmaceutical market. Finally, we have launched the registrational Phase 3 TROPICS-02 study in late-line HR+/HER2 metastatic breast cancer to potentially address a large unmet market," said Behzad Aghazadeh, Executive Chairman of Immunomedics.

The randomized global TROPICS-02 study is expected to enroll approximately 400 patients with hormonal receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2–) metastatic breast cancer (mBC) who have failed at least two prior chemotherapy regimens for metastatic disease. Patients are randomized to receive either sacituzumab govitecan or physician’s choice of eribulin, capecitabine, gemcitabine or vinorelbine.

The primary endpoint will be progression-free survival with overall survival serving as secondary endpoint. The protocol also allows for an interim analysis of overall response rate (ORR) and duration of response (DoR), the results of which could support a potential accelerated approval submission.

Recent Company Highlights

Phase 2 data with sacituzumab govitecan in metastatic triple-negative breast cancer (mTNBC) were published in the New England Journal of Medicine.1

The Company’s sales force is co-promoting Balversa (erdafitinib) in the U.S. with Janssen Biotech Inc. until the end of March 2020. Should sacituzumab govitecan be approved for mTNBC in the U.S. before that time, Immunomedics is only required to support Balversa in second position detail.

The Company entered into an exclusive license agreement with Everest Medicines, the largest single-asset in-licensing deal for regional China to-date, to support development, registration, and commercialization of sacituzumab govitecan for key cancer indications in Greater China, South Korea and certain Southeast Asian countries. The Company will receive a $65 million upfront payment and an additional $60 million based on the FDA approval of sacituzumab govitecan in mTNBC in the U.S., and has the potential to receive an additional $710 million, if certain milestones are achieved.

The Company met with the FDA to discuss issues raised in the Complete Response Letter (CRL) it received in January 2019. After receiving clarity from the regulatory agency, the Company plans to resubmit its Biologics License Application in early fourth quarter of 2019 seeking the approval of sacituzumab govitecan for the treatment of patients with mTNBC who have received two prior therapies for metastatic disease.

A registrational Phase 3 TROPICS-02 study of sacituzumab govitecan was launched in late-line HR+/HER2‒ mBC. This study could support a potential accelerated approval submission with interim results of ORR and DoR.
Results for the First Quarter of 2019
The Company had no revenues for the three months ended March 31, 2019, due primarily to the discontinued sale of LeukoScan during the quarter ended March 31, 2018 in order for the Company to focus on its ADC business. Revenues in the comparable quarter ended March 31, 2018, were approximately $0.5 million.

Total costs and expenses were $79.6 million for the three months ended March 31, 2019, compared to $38.1 million for the comparable quarter ended March 31, 2018, due primarily to a $29.3 million increase in research and development expenses, a $6.7 million increase in general and administrative expenses, and a $5.5 million increase in sales and marketing expenses. Most of these increases were attributable to activities related to preparations for the potential approval and commercial launch of sacituzumab govitecan for patients with at least two prior lines of treatment for metastatic TNBC in the United States, and to expanded clinical development of sacituzumab govitecan into other indications.

The Company had no non-cash income or expense for the three months ending March 31, 2019, compared to a $9.8 million non-cash gain for the comparable quarter ended March 31, 2018, due to a decrease in the fair value of outstanding warrants. There were no warrants outstanding as of March 31, 2019.

Interest expense was $10.0 million for the three months ended March 31, 2019, compared to $10.9 million for the comparable quarter March 31, 2018. The decrease was due primarily to changes in the fair value of our debt balances as a result of the agreement with RPI Finance Trust.

Net loss attributable to stockholders was $87.3 million, or $0.46 per share, for the three months ended March 31, 2019, compared to $35.5 million, or $0.21 per share, for the comparable quarter ended March 31, 2018.

As of March 31, 2019, the Company had $442.7 million in cash, cash equivalents, and marketable securities, which it believes is adequate to support its clinical development plan for sacituzumab govitecan; further build its clinical and manufacturing infrastructure and fund its operations through 2020.

Conference Call
The Company will host a conference call and live audio webcast today at 8:00 a.m. Eastern Time to discuss first quarter 2019 financial results and provide a corporate update. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 5357619. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.

Reference

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On May 9, 2019 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported the launch of a generic version of Tarceva1 (erlotinib) tablets, 100 and 150 mg, in the U.S (Press release, Teva, MAY 9, 2019, View Source [SID1234536093]).

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Erlotinib Tablets are a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Erlotinib Tablets are also indicated for first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine.

"The launch of generic Tarceva tablets marks an important addition to our offering of oncology products," said Brendan O’Grady, EVP and Head of North America Commercial.

With nearly 500 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in eight generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

Tarceva tablets have annual sales of $202 million in the U.S., according to IQVIA data as of February 2019.

About Erlotinib Tablets

Erlotinib Tablets are indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Limitations of use: Safety and efficacy of Erlotinib Tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. Erlotinib Tablets are not recommended for use in combination with platinum-based chemotherapy.

Erlotinib Tablets in combination with gemcitabine are indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

IMPORTANT SAFETY INFORMATION

Cases of serious interstitial lung disease, including fatal cases, can occur with erlotinib treatment. Hepatorenal syndrome, severe acute renal failure including fatal cases, and renal insufficiency can occur with erlotinib treatment. Renal failure may arise from exacerbation of underlying baseline hepatic impairment or severe dehydration. Hepatic failure and hepatorenal syndrome, including fatal cases, can occur with erlotinib treatment in patients with normal hepatic function; the risk of hepatic toxicity is increased in patients with baseline hepatic impairment.

Gastrointestinal perforation, including fatal cases, can occur with erlotinib treatment. Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease may be at increased risk of perforation. Bullous, blistering and exfoliative skin conditions, including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal, can occur with erlotinib treatment. The risk of cerebrovascular accident is increased in patients with pancreatic cancer. The risk of microangiopathic hemolytic anemia is increased in patients with pancreatic cancer.

Decreased tear production, abnormal eyelash growth, keratoconjunctivitis sicca or keratitis can occur with erlotinib treatment and can lead to corneal perforation or ulceration. Severe and fatal hemorrhage associated with International Normalized Ratio (INR) elevations can occur when erlotinib and warfarin are administered concurrently. Based on animal data and its mechanism of action, erlotinib can cause fetal harm when administered to a pregnant woman.

The most common adverse reactions (≥ 20%) with erlotinib from a pooled analysis in patients with NSCLC across all approved lines of therapy, with and without EGFR mutations, and in patients with pancreatic cancer were rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, and vomiting.

For more information, please see accompanying Full Prescribing Information. A copy may be requested from Teva U.S. Medical Information at 888-TEVA-USA (888-838-2872), [email protected], or Teva’s Public Relations or Investor Relations contacts.