On August 5, 2019 Compugen Ltd. (Nasdaq: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported financial results for the second quarter ended June 30, 2019 (Press release, Compugen, AUG 5, 2019, View Source [SID1234538122]).

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"We continued the strong execution of our clinical program throughout the second quarter of 2019," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "This includes the important milestone of first patient dosed in the combination arm of our Phase 1 study of COM701 and Opdivo, which remains on-track to complete enrollment this year. Additionally, the COM701 monotherapy dose escalation arm is progressing, and we look forward to rapidly advancing to the monotherapy expansion cohort later this year accompanied by our targeted, biomarker driven approach. Finally, we are excited to advance our second internally developed asset, COM902, toward an IND filing later this year. These activities and the progress we are making highlight our ability and commitment to translate our computational discoveries into meaningful and exciting clinical cancer immunotherapy programs."

"After utilizing the ATM program together with the streamlined corporate structure implemented in March, we now have sufficient cash resources expected to fund operations through mid-2021. We will remain diligent in effectively using our capital to continue to execute on our pipeline programs and ensure our future growth," added Dr. Cohen-Dayag.

Recent Corporate Highlights

Dosed first patient in the combination arm of the Phase 1 study for COM701, combining escalating doses of COM701 with a fixed dose of Opdivo (nivolumab) in patients with advanced solid tumors. Combination arms of the study are conducted under the clinical collaboration agreement entered into with Bristol-Myers Squibb in October 2018.

Reported at a trial-in-progress poster presentation at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting in June that the sixth dose level patient cohort of COM701 monotherapy has been completed and that no dose-limiting toxicities were found. Clinical and laboratory assessment for safety and tolerability are ongoing for this and earlier dose level patient cohorts.

Awarded U.S. Patent No. 10,351,625 by the U.S. Patent and Trademark Office, which covers the method of use of COM701 in combination with any anti-PD-1 antibody.

Financial Results

R&D expenses for the second quarter ended June 30, 2019 were $4.9 million, compared with $8.0 million for the comparable period in 2018. The decrease in R&D expenses was primarily due to the decrease in preclinical activities related to COM902, most of which were done in 2018, and the cost reduction measures announced by the Company in the first quarter of 2019. This decrease was partially offset by an increase in R&D expenses associated with clinical-related activities for the COM701 Phase 1 trial, which began in the second half of 2018.

Taxes on Income for the second quarter of 2019 reflect a tax benefit of $0.7 million due to a refund of withholding taxes from previous years.

Net loss for the second quarter of 2019 was $6.0 million, or $0.10 per basic and diluted share, compared with a net loss of $10.2 million, or $0.19 per basic and diluted share, in the comparable period of 2018.

As of June 30, 2019, cash, cash related accounts, short-term and long-term bank deposits totaled $37.0 million, compared with $45.7 million at December 31, 2018. The Company has no debt.

During the three months ended June 30, 2019, the Company sold approximately 1.0 million ordinary shares under its "at-the-market" (ATM) facility pursuant to a sales agreement entered into with Cantor Fitzgerald & Co. in May 2018 for aggregate proceeds of approximately $3.8 million, net of commissions to Cantor and expenses related to the offering. Since June 30, 2019, the Company sold approximately 5.2 million ordinary shares under the ATM for aggregate proceeds of approximately $15.5 million, net of commissions to Cantor and expenses related to the offering.

The Company now believes that it has sufficient cash resources to fund its operations through mid-2021 and therefore decided to cancel its remaining ATM program.

Conference Call and Webcast Information
Compugen will hold a conference call to discuss its second quarter 2019 results today, August 5, 2019, at 8:30 AM ET. To access the live conference call by telephone, please dial 1-888-407-2553 from the U.S., or +972-3-918-0644 internationally. The conference call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On August 5, 2019 SFA Therapeutics, Inc. reported that the company has filed an FDA application requesting Orphan Drug Designation (ODD) for SFA001, the company’s novel microbiome-based treatment for human hepatocellular carcinoma (HCC) (Press release, SFA Therapeutics, AUG 5, 2019, View Source [SID1234538140]).

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"In seeking Orphan Drug Designation (ODD) for this patented new human-microbiome-based drug, we are asking FDA to grant special status to the treatment of the most prevalent form of liver cancer. ODD status would provide significant drug development and tax advantages as well as expanded market exclusivity," stated Ira Spector, PhD, SFA Therapeutics’ CEO. "These advantages would undoubtedly speed the drug’s availability for a disease that kills hundreds of thousands of patients annually world-wide and has a low survival rate."

While hepatocellular carcinoma afflicts 54,000 patients per year in the US (Cancer.net), the World Health Organization estimates the disease causes as many as 700,000 deaths per year globally –especially in China and other parts of Asia. SFA Therapeutics has already been granted two patents recognizing the uniqueness of SFA001 treatment. In validated transgenic HBX animal models, SFA001 has been shown to block the progression of hepatitis B to HCC and has been shown to treat HCC with a non-chemotoxic mechanism in two forms of human HCC.

On August 5, 2019 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the second quarter ended June 30, 2019 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, AUG 5, 2019, View Source [SID1234538164]).

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"Strong momentum is with us as we move closer to our goal of releasing topline data from no fewer than five clinical trials over the next 18 months," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "First and foremost, we look forward to announcing topline results from the pivotal ADVOCATE Phase III trial of avacopan in ANCA-associated vasculitis in the fourth quarter of this year. The ADVOCATE trial is based on a wealth of data from well controlled pharmacological and clinical studies, including the successful multi-center, placebo controlled CLEAR and CLASSIC Phase II clinical trials. That foundation provides the basis for optimism that avacopan will provide much needed relief for ANCA patients."

"Recently we reached another milestone by completing patient enrollment in our LUMINA 1 trial of our second drug candidate, CCX140, in patients with primary FSGS, and we expect to release topline data in the first half of the coming year."

"Rounding out the pipeline readout roster through the coming year, our clinical trials of avacopan in C3 glomerulopathy and hidradenitis suppurativa, along with our LUMINA 2 trial of CCX140 in patients with nephrotic proteinuria primary FSGS, are also enrolling well. We expect to release top line data from these three clinical trials during the course of 2020."

"We continue to execute on our 2019 goals, fortified by our strong financial position. In short, we have the people, the assets, and the experience to deliver real value to investors and patients alike, as I believe this important time in our history will now begin to reveal."

Recent Highlights

Remained on track for Q4 topline data from the ADVOCATE global Phase III trial of avacopan in 331 patients with ANCA-associated Vasculitis.

Completed patient screening in the Company’s LUMINA 1 Phase II randomized clinical trial of CCX140, an inhibitor of the chemokine receptor known as CCR2, in patients with sub-nephrotic primary Focal Segmental Glomerulosclerosis (FSGS), another rare kidney disease. The last patient is expected to be randomized in mid-August and top line data anticipated in the first half of 2020. The single-arm, open label LUMINA 2 study continues to enroll, evaluating CCX140 in patients with the rarer and more severe nephrotic proteinuria primary FSGS.

ACCOLADE Phase II clinical trial of avacopan in patients with the rare kidney disease C3 Glomerulopathy (C3G, a devastating and expensive kidney disease with no approved effective treatment), reached fifty percent in overall enrollment and nearly 100% in the first stratum of patients with high levels of activated complement in the blood.

Acceleration in site activation and patient enrollment in the Company’s AURORA Phase IIb clinical trial of avacopan for the treatment of the chronic disabling skin disease Hidradenitis Suppurativa (HS), with over 50% sites now activated and approximately 25% patients enrolled to date.

First Quarter 2019 Financial Results

Revenue was $7.2 million for the second quarter of 2019, compared to $15.0 million for the same period in 2018. Revenue is recognized based on the proportionate amount of costs incurred as a percentage of total budgeted costs to fulfill the performance obligations under the Company’s avacopan and CCX140 commercialization agreements with Vifor Pharma. The decrease from 2018 to 2019 was primarily due to a higher proportion of avacopan related costs relative to budgeted costs incurred in 2018.

Research and development expenses were $17.6 million for the second quarter of 2019, compared to $17.8 million for the same period in 2018. Expenses decreased in 2019 for the avacopan ADVOCATE Phase III pivotal trial as the study was fully enrolled in 2018, while Phase II clinical expenses increased primarily due to patient enrollment of the avacopan AURORA Phase II clinical trial in patients with HS and the two CCX140 LUMINA Phase II clinical trials in patients with FSGS.

General and administrative expenses were $5.6 million for the second quarter of 2019, compared to $4.7 million for the same period in 2018. The increase from 2018 to 2019 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, and higher professional fees.

Net loss for the second quarter of 2019 was $15.2 million, compared to $6.9 million for the same period in 2018.

Total shares outstanding at June 30, 2019 were approximately 58.2 million shares.

Cash, cash equivalents and investments totaled $223.1 million at June 30, 2019. The Company expects to utilize cash and investments in the range of $70.0 million to $80.0 million in 2019.

Conference Call and Webcast

The Company will host a conference call and webcast today, August 5, 2019 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 7548439. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.

On August 5, 2019 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 financial results for the three and six months ended June 30, 2019 and highlighted recent corporate updates (Press release, Heron Therapeutics, AUG 5, 2019, View Source [SID1234538123]).

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Recent Corporate Updates

Pain Management Franchise

Complete Response Letter Received from the FDA Regarding the NDA for HTX-011: A Complete Response Letter (CRL) was received from the U.S. Food and Drug Administration (FDA) on April 30, 2019 regarding the Company’s New Drug Application (NDA) for HTX-011 for postoperative pain management. The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional Chemistry, Manufacturing and Controls (CMC) and non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues, and there is no requirement for further clinical studies or data analyses.

95% of Postoperative Patients Remain Opioid-Free when HTX-011 Is Given with an Over-the-Counter Analgesic Regimen in Real-world Study in Hernia Repair Surgery: In May 2019, we announced the results of a multi-center postoperative pain management study in 93 patients that provides real-world evidence of opioid-free recovery in patients undergoing outpatient inguinal hernia repair surgery who received the investigational agent, HTX-011, together with a scheduled background regimen of generic over-the-counter (OTC) oral analgesics (acetaminophen and ibuprofen). Ninety-one percent (91%) of patients receiving HTX-011 with the OTC analgesic regimen were discharged without an opioid prescription, and none of these patients subsequently requested an opioid for postoperative pain.

Results of Phase 3 EPOCH 1 Study Published: In May 2019, the results from the pivotal Phase 3 EPOCH 1 bunionectomy study of HTX-011 were published by the Regional Anesthesia & Pain Medicine journal.

CINV Franchise

CINV 2019 Net Product Sales: For the three months ended June 30, 2019, chemotherapy-induced nausea and vomiting (CINV) franchise net product sales were $36.7 million, up 112% from the same period in 2018, and up 16% from the three months ended March 31, 2019. For the six months ended June 30, 2019, CINV franchise net product sales were $68.3 million, up 137% from the same period in 2018. Heron reaffirms full-year 2019 CINV franchise net product sales guidance of $115 million to $120 million.

CINVANTI Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and six months ended June 30, 2019 were $33.2 million and $61.2 million, respectively, compared to $11.2 million and $16.4 million, respectively, for the same periods in 2018.

SUSTOL Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and six months ended June 30, 2019 were $3.5 million and $7.1 million, respectively, compared to $6.1 million and $12.4 million for the same periods in 2018.

"We expect to meet with the FDA shortly to discuss our responses to the CRL for HTX-011, and we remain focused on resubmitting the NDA as soon as possible," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "Our CINV franchise continues to perform well, highlighted by strong net product sales in the second quarter."

Financial Results

Net product sales for the three and six months ended June 30, 2019 were $36.7 million and $68.3 million, respectively, compared to $17.3 million and $28.8 million, respectively, for the same periods in 2018.

Heron’s net loss for the three and six months ended June 30, 2019 was $50.2 million and $113.2 million, or $0.63 per share and $1.43 per share, respectively, compared to $38.7 million and $90.9 million, or $0.54 per share and $1.33 per share, respectively, for the same periods in 2018. Net loss for the three and six months ended June 30, 2019 included non-cash, stock-based compensation expense of $12.7 million and $30.6 million, respectively, compared to $7.8 million and $15.5 million, respectively, for the same periods in 2018.

As of June 30, 2019, Heron had cash, cash equivalents and short-term investments of $276.0 million, compared to $332.4 million as of December 31, 2018. Net cash used for operating activities for the six months ended June 30, 2019 was $72.1 million compared to $122.4 million for the same period in 2018. Heron expects to end the year with more than $190 million in cash, cash equivalents and short-term investments.

About HTX-011 for Postoperative Pain

HTX-011, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine solution in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the FDA in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted an NDA for HTX-011 to the FDA in October of 2018 and received Priority Review designation in December of 2018. A CRL was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to CMC and non-clinical information. No issues related to clinical efficacy or safety were noted. An MAA for HTX-011 was validated by the EMA in March 2019 for review under the Centralised Procedure.

About CINVANTI (aprepitant) injectable emulsion

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin, and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). CINVANTI is an IV formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist (RA). CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0 – 24 hours after chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy). CINVANTI is the only IV formulation of an NK1 RA indicated for the prevention of acute and delayed nausea and vomiting associated with HEC and nausea and vomiting associated with MEC that is free of polysorbate 80 or any other synthetic surfactant. The FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute infusion or a 2-minute injection.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL (granisetron) extended-release injection

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0 – 24 hours after chemotherapy) and delayed phase (24 – 120 hours after chemotherapy).

Please see full prescribing information at www.SUSTOL.com.

On August 5, 2019 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that it will report its second quarter 2019 financial results on Thursday, August 8, 2019 (Press release, Gossamer Bio, AUG 5, 2019, View Source [SID1234538141]).

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In connection with the earnings release, Gossamer’s management team will host a live conference call and webcast at 4:30 p.m. ET on Thursday, August 8, 2019, to discuss the Company’s financial results and provide a corporate update.

The live audio webcast may be accessed through the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source Alternatively, the conference call may be accessed through the following:

Conference ID: 1393207
Domestic Dial-in Number: (866) 221-1654
International Dial-in Number: (470) 495-9466
Live Webcast: View Source

A replay of the audio webcast will be available for 30 days on the Investors section of the Company’s website, www.gossamerbio.com.