On August 6, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the second quarter ended June 30, 2019 (Press release, Curis, AUG 6, 2019, View Source [SID1234538187]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Today, we are excited to announce initial data from our ongoing Phase 1 study of CA-4948 in patients with non-Hodgkin lymphoma, demonstrating anti-cancer activity for CA-4948 with tumor reduction observed in multiple patients across multiple dose levels," said James Dentzer, President and Chief Executive Officer of Curis. "We are especially pleased to see such encouraging results, as we are still in the middle of the dose optimization phase of the study. As a result of this positive readout, we are announcing today our decision to advance CA-4948 into the clinic in a new study of patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). We look to provide more detailed guidance on the timing of that study later this year."

"I am very pleased with the initial data we are seeing in our ongoing Phase 1 trial of CA-4948," said Robert Martell, Head of R&D of Curis. "As we increase dosing, we have observed continued evidence of pharmacodynamic target inhibition with dose-proportional increases in pharmacokinetic exposure. With the caveats of small cohort sizes and low initial dosage levels, we found patients experienced anti-tumor activity at multiple doses, including two of the patients at the 200mg BID dose level. And, importantly, all of these findings have been observed at tolerable dose levels. We look forward to reporting additional data in this ongoing study at an upcoming medical conference."

Separately, ongoing clinical studies of fimepinostat and CA-170 remain on track to provide initial data, for both studies, later this year.

Second Quarter 2019 and Recent Operational Highlights

Precision oncology, fimepinostat (HDAC/PI3K inhibitor):

Curis has initiated a Phase 1 study of fimepinostat (a MYC suppressor) with venetoclax (a BCL-2 inhibitor) combination regimen in diffuse large B-cell lymphoma (DLBCL), including patients with double-hit/double-expressor (DH/DE) lymphoma, or High-Grade B-Cell Lymphoma (HGBL). In preclinical models, fimepinostat administered in combination with venetoclax resulted in an enhanced benefit relative to each agent alone.
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):

Today, Curis announced initial safety and efficacy data from its Phase 1 dose escalation study of CA-4948 in patients with non-Hodgkin lymphoma, including those with MYD88 alterations. As previously reported, the Phase 1 study of CA-4948 has advanced through five dose levels and is now being studied at exposures that resulted in anticancer efficacy in preclinical animal models. In the ongoing Phase 1 study, CA-4948 has demonstrated pharmacokinetic activity linearly-associated with dosing and clear signs of pharmacodynamic inhibition of the target. In addition, tumor burden reduction was observed in multiple patients across multiple dose levels with an acceptable safety profile. Treatment with CA-4948 at 200mg twice-daily (BID) is generally safe and well-tolerated, with no dose-limiting toxicities (DLTs) observed. The Company is currently enrolling patients in the study at 400mg BID and plans to continue dose escalation in the study to determine the optimal dose for clinical development.

Today, Curis announced that it will initiate a separate Phase 1 trial of CA-4948 in patients with AML and MDS. In June 2019, the Company highlighted a publication in Nature Cell Biology showing that a cancer-causing splicing variant of IRAK4 (IRAK4-L) is dominant in the majority of cases of AML and MDS. In addition, specific mutations of the U2AF1 splicing factor induce IRAK4-L, which has potential therapeutic targetability by CA-4948. The findings present the inhibition of IRAK4 as a potential treatment option for patients with myeloid malignancies expressing IRAK4-L and with U2AF1 mutations.
Immuno-oncology, CA-170 (VISTA / PDL1 antagonist; Aurigene collaboration):

Phase 1 study of CA-170 in mesothelioma patients (high VISTA expressors) is ongoing. The trial completed enrollment in May 2019.
Upcoming 2019 Milestones

Report update of initial safety and efficacy data from the Phase 1 dose escalation study of CA-4948 in patients with NHL at an upcoming medical conference.

Report initial safety data from the Phase 1 study of the combination of fimepinostat and venetoclax regimen in patients with R/R DLBCL, including patients with DH/DE lymphoma, or HGBL, in the second half of 2019.

Report initial efficacy data from the Phase 1 study of CA-170 in patients with mesothelioma in the second half of 2019.
Second Quarter 2019 Financial Results

Curis reported a net loss of $7.2 million, or $0.22 per share on both a basic and diluted basis for the second quarter of 2019, as compared to a net loss of $8.7 million, or $0.26 per share on both a basic and diluted basis for the same period in 2018. Curis reported a net loss of $17.1 million, or $0.52 per share, on both a basic and diluted basis for the six months ended June 30, 2019, as compared to a net loss of $19.4 million, or $0.59 per share on both a basic and diluted basis for the same period in 2018.

Revenues for the second quarter of 2019 were $2.1 million, as compared to $2.4 million for the same period in 2018. Revenues for the six months ended June 30, 2019 were $3.9 million, as compared to $4.8 million for the same period in 2018. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses were $8.2 million for the second quarter of 2019, as compared to $10.2 million for the same period in 2018. Operating expenses for the six months ended June 30, 2019 were $15.6 million, as compared to $22.6 million for the same period in 2018, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.1 million for both the second quarter of 2019 and 2018. Cost of royalty revenues for the six months ended June 30, 2019 were $0.2 million, as compared to $0.3 million for the same period in 2018.

Research and Development Expenses (R&D). R&D expenses were $5.6 million for the second quarter of 2019, as compared to $6.5 million for the same period in 2018. The decrease was primarily driven by lower employee related expenses partially offset by an overall increase in direct research and development expenses. R&D expenses were $9.7 million for the six months ended June 30, 2019 as compared to $14.7 million for the same period in 2018.

General and Administrative Expenses (G&A). G&A expenses were $2.5 million for the second quarter of 2019 as compared to $3.6 million for the same period in 2018. The decrease was primarily driven by lower personnel, legal services and stock-based compensation during the period. G&A expenses were $5.7 million for the six months ended June 30, 2019, as compared to $7.6 million for the same period in 2018.

Other Expenses. Net other expense for the second quarter 2019 was $1.1 million, as compared to $0.8 million for the same period in 2018. Net other expense for the second quarter 2019 primarily consisted of non-cash imputed interest expense related to future royalty payments, whereas in 2018 the expense related to interest accrued on Curis Royalty’s debt obligations. Other expense, net was $5.4 million and $1.6 million for the six months ended June 30, 2019 and 2018, respectively.

As of June 30, 2019, Curis’s cash, cash equivalents, marketable securities and investments totaled $35.3 million and there were approximately 33.2 million shares of common stock outstanding.

Conference Call Information

Curis management will host a conference call today, August 6, 2019, at 4:30 p.m. EDT, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. EDT. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

On August 6, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, reported that it will release its second quarter 2019 financial results before the market opens on Thursday, August 8, 2019 (Press release, Agenus, AUG 6, 2019, View Source [SID1234538185]). Agenus executives will host a conference call and webcast at 8:30 a.m. ET the same day.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

To access the live call, dial 1-844-492-3727 (U.S.) or 1-412-317-5118 (International) and ask to be joined into the Agenus call. The call will also be webcast and will be 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 until November 7, 2019.

On August 6, 2019 Cambrex Corporation (NYSE: CBM), the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, reported that second quarter 2019 financial results will be released on Friday, August 9, 2019 before the market opens (Press release, Cambrex, AUG 6, 2019, View Source [SID1234538184]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The Company will host a conference call to discuss the financial results.

Second Quarter 2019 Earnings Conference Call

When: Friday, August 9, 2019 at 8:30 a.m. Eastern Time

Dial-in: 1-888-220-8451 for U.S.
1-323-794-2588 for International
Passcode: 9175707

Dial-in Replay: 1-888-203-1112 for U.S.
1-719-457-0820 for International
Passcode: 9175707
Available through Friday, August 16, 2019

Webcast: www.cambrex.com

On August 6, 2019 Anchiano Therapeutics Ltd. (Nasdaq: ANCN) ("Anchiano"), a pivotal-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat cancer, reported financial results for its second quarter and six months ended June 30, 2019 (Press release, Anchiano Therapeutics, AUG 6, 2019, View Source [SID1234538183]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Key Developments and Recent Highlights

·Appointed Salar Roshan as the Head of Business Development to focus on leading Anchiano’s strategic initiatives.

·Delisted the company’s ordinary shares from trading on the Tel Aviv Stock Exchange (TASE). Anchiano’s American Depositary Shares, each representing five of its ordinary shares, continue to be traded on the Nasdaq under the ticker "ANCN."

Second Quarter 2019 Financial Results:

On June 30, 2019, Anchiano had total cash and cash equivalents of approximately $27 million, compared to approximately $7.5 million on December 31, 2018.

Research and development expenses for the second quarter of 2019 were approximately $2.6 million, compared to approximately $1.9 million for the second quarter of 2018. This increase was mainly due to an increase in clinical trial expenses and an increase in clinical manpower expenses.

General and administrative expenses for the second quarter of 2019 were approximately $1.9 million, compared to approximately $2.3 million for the second quarter of 2018. This decrease was mainly due to a decrease in share-based payment and issuance expenses, offset by increases in professional, consulting, rental, insurance and manpower expenses.

Financing income (expenses), net, for the second quarter of 2019 were approximately $2.8 million, compared to approximately $(0.8) million for the second quarter of 2018. This change was mainly due to changes in the fair value of derivative financial instruments.

Net loss for the second quarter of 2019 was approximately $1.8 million, or $0.05 per share, compared to approximately $5.3 million, or $0.55 per share in the second quarter of 2018.

Six Months Ended June 30, 2019 Financial Results:

Research and development expenses for the six months ended June 30, 2019 were approximately $6.7 million, compared to approximately $4.4 million for the same period in 2018. This increase was mainly due to an increase in clinical trial expenses, manufacturing expenses and an increase in clinical manpower expenses.

General and administrative expenses for the six months ended June 30, 2019 were approximately $3.1 million, similar to expenses of approximately $3.2 million for the same period in 2018. The decrease was mainly due to a decrease in share-based payment and issuance expenses, offset by increases in professional, consulting, rental, insurance and manpower expenses.

Financing expenses, net, in the six months ended June 30, 2019 were approximately $10.1 million, compared to approximately $0.9 million for the same period in 2018. This change was mainly due to changes in the fair value of derivative financial instruments.

Net loss for the six months ended June 30, 2019 was approximately $20.3 million, or $0.64 per share, compared to approximately $8.8 million, or $0.92 per share for the same period in 2018.

On August 6, 2019 XOMA Corporation (Nasdaq: XOMA), reported its second quarter 2019 royalty asset portfolio highlights and financial results (Press release, Xoma, AUG 6, 2019, View Source [SID1234538182]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"The second quarter began with our latest acquisition of rights to future milestones and royalties associated with five development-stage anti-thrombotic hematology assets from Aronora, Inc. Of the five assets, three are being developed under a collaboration with Bayer, a global leader in hematology therapeutics," stated Jim Neal, Chief Executive Officer at XOMA. "We believe we are well-positioned to continue executing on our royalty-aggregator strategy to create near- and long-term value for shareholders."

Second Quarter 2019 Updates About Partnered Assets in Development
"The quarter also was marked with three notable developments within XOMA’s portfolio of partnered assets. Novartis made two important iscalimab data presentations and began dosing patients in a gevokizumab oncology study. Sesen Bio announced its agreement with the U.S. Food and Drug Administration to move forward on a Biologics License Application for Vicinium," Mr. Neal added. "As well, we received notification that clinical programs are being launched for several additional assets to which XOMA holds a royalty interest."

Novartis and iscalimab
During a late-breaker session at the American Transplant Congress held in June, Novartis presented data on iscalimab (CFZ533) that showed 60% of iscalimab-treated transplant patients have normal kidney histology at least one year after transplant, compared with 0% with tacrolimus (current standard of care)1. Less than half of donated kidneys last 10 years, so durability is a significant unmet need for patients who are living with or waiting for a transplant2. More than 100,000 patients are on the U.S. kidney transplant waiting list with a chronic shortfall of donors3. Iscalimab could prove to be a valuable new option for these transplant patients.

Data from a separate iscalimab study were presented at the European Congress of Rheumatology 2019. The presentation, titled Subcutaneous Dosing of the Novel Anti-CD40 Antibody Iscalimab Achieves Target Drug Exposure and Clinical Efficacy in Primary Sjögren’s Syndrome; Results of a Phase IIa Randomized Open Label Two Arm Parallel Group Trial, concluded the study results further support the safety and efficacy of iscalimab in primary Sjögren’s syndrome and the suitability of subcutaneous dosing for future development. From a clinical point of view, the ability to treat patients with a subcutaneous formulation would help reduce the ever-increasing demands on infusion clinics.

Novartis and gevokizumab
Gevokizumab (VPM087), an anti-IL1β monoclonal antibody that XOMA discovered and initially developed, is now actively progressing in a Novartis oncology development program. Recently the first patient was dosed with gevokizumab in the dose-finding portion of a study in combination with standard of care anti-cancer therapies in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer, and metastatic renal cell carcinoma.

Sesen Bio, Inc.
Sesen Bio had a successful pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) regarding Vicinium for the treatment of patients with high-risk, Bacillus Calmette-Guérin unresponsive, non-muscle invasive bladder cancer. Sesen has stated it intends to begin filing its BLA in the fourth quarter of 2019.

Other partnered assets in development
Multiple clinical studies were initiated with assets for which XOMA holds a royalty interest. Takeda expanded its TAK-079 development program with a Phase 1 study to evaluate subcutaneous TAK-079 added to standard of care regimens in participants with newly diagnosed multiple myeloma. Molecular Templates announced the FDA accepted its Investigational New Drug application for TAK-169, an engineered toxin body targeting CD38. Molecular Templates and its partner, Takeda, expect to initiate an open-label Phase 1 dose escalation and expansion study in relapsed/refractory multiple myeloma patients. Rezolute, Inc., disclosed it has resumed its Phase 1 study for AB101 and dosed the first patient in the study’s second cohort. Aronora initiated a new study to evaluate the safety and efficacy of ProCase (AB002) in patients with end stage renal disease on chronic hemodialysis.

Additionally, AVEO Oncology announced positive results from the investigator-initiated Phase Ib Ficlatuzumab-Cytarabine Trial In Patients With Relapsed And Refractory Acute Myeloid Leukemia study. Data showed six of 12 patients who received ficlatuzumab and cytarabine at the maximally tolerated dose achieved a complete response. Study results were presented in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019.

Business Highlights
Acquired the rights to potential royalty payments and a portion of the potential milestone payments associated with five anti-thrombotic hematology assets from Aronora, Inc. Three of the assets are covered by a collaboration with Bayer, a global leader in hematology therapeutics. Two of the collaboration assets are in early to mid-stages of development and the third is a Phase 2 candidate that is subject to an option. The Company also agreed to acquire the rights to potential royalty payments and a portion of the potential upfront and milestone payments associated with two unpartnered hematology programs from Aronora. XOMA made a $6 million payment and will make an additional payment of up to $3 million to Aronora upon fulfillment of certain other conditions. In return, XOMA will receive, on average, low single-digit royalties on future sales of these five products and 10% of the milestones associated with each of the assets. In addition, the Company could pay Aronora sales-based milestones on each asset if XOMA’s royalty receipts related to each program exceed certain thresholds.

"From our legacy history with our phage display platform, we understand the value of a technology platform. It serves as an engine that can generate multiple product candidates, all of which have the potential to produce milestone and royalty revenues. During the second quarter, we added a second technology platform relationship to our royalty interest portfolio. Sonnet BioTherapeutics, Inc., has a platform and pipeline that were developed using XOMA’s phage display technology," concluded Mr. Neal. Sonnet has developed a Fully Human Albumin Binding platform focused on enhancing half-life and tumor targeting to enhance immune response to improve cancer survival. Its approach is unique in that their team is developing bi- and tri-functional therapies to stimulate and/or block immune-modulating targets. Sonnet believes its technology can activate and sustain an immune response selectively against the targeted tumor. XOMA will receive milestones and a low single-digit royalty on future commercial sales of any therapeutic product that utilizes licensed XOMA intellectual property.

Financial Results
XOMA recorded total revenues of $1.0 million for the second quarter of 2019, compared with $2.3 million recorded for the second quarter of 2018. The decrease for the three months ended June 30, 2019, as compared to the same period in 2018, was due primarily to $1.8 million recognized under the Company’s license agreement with Rezolute in the second quarter of 2018.

Research and development expenses were $0.7 million for the second quarter of 2019, compared to $0.4 million for the second quarter of 2018. The increase of $0.3 million for the three months ended June 30, 2019, compared to the same period of 2018, was primarily due to a $0.5 million pass-through license fee incurred based on the achievement of a development milestone by one of our partners, partially offset by a $0.1 million decrease in salary and related expenses.

General and administrative expenses were $4.9 million for the second quarter of 2019, compared to $4.4 million for the second quarter of 2018. The increase of $0.5 million for the three months ended June 30, 2019, as compared to the same period of 2018, was primarily due to increases of $0.3 million in stock-based compensation expenses and $0.2 million in legal and accounting expenses.

In the second quarter of 2019, XOMA recorded $0.4 million in total interest expense, as compared to $0.2 million in the corresponding period of 2018. The increase in interest expense compared with 2018 is primarily due to the outstanding Silicon Valley Bank (SVB) loan balance. In the second quarter, XOMA borrowed an additional $3.0 million under the SVB loan agreement, and as of June 30, 2019, a total of $10.5 million was outstanding.

Total other income, net was $1.1 million for the second quarter of 2019, compared to other expense of $1.2 million for the second quarter of 2018. During the three months ended June 30, 2019, the fair value of the long-term equity securities held by XOMA increased by $31,000. During the three months ended June 30, 2019, XOMA was party to four sublease agreements, compared with two sublease agreements for the same period in 2018, resulting in $0.8 million in sublease income during the second quarter of 2019 and $0.4 million in the corresponding period of 2018. In the second quarter of 2018, XOMA recognized $1.0 million of other income under the agreement with Ology Bioservices related to the disposition of XOMA’s biodefense business in March 2016; no further payments are due.

Net loss for the second quarter of 2019 was $4.1 million, compared to $1.9 million for the second quarter of 2018.

On June 30, 2019, XOMA had cash and cash equivalents of $42.3 million. The Company ended December 31, 2018, with cash and cash equivalents of $45.8 million. The Company’s current cash and cash equivalents are expected to be sufficient to fund its operations for multiple years.

Tom Burns, Chief Financial Officer of XOMA, commented, "XOMA congratulates Rezolute for its recent announcement that its investors have exercised their full combined $20 million option to purchase shares of Rezolute common stock. In conjunction with this, we recently received $2.9 million from Rezolute."