On August 6, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, reported financial results for the second quarter ended June 30, 2019 and provided a review of recent business and clinical highlights (Press release, Xencor, AUG 6, 2019, View Source [SID1234538188]).

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"Over the last two years, Xencor has initiated six Phase 1 clinical studies evaluating XmAb bispecific antibodies—both T cell engagers and tumor microenvironment (TME) activators—in patients with many types of advanced cancers, and we have also entered into strategic collaborations to advance select programs with our partners," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "We anticipate several initial data presentations from these programs in the second half of 2019 and first half of 2020, and our strong financial position supports our broad pipeline and research into novel antibodies and cytokines engineered with XmAb bispecific technologies."

Dr. Dahiyat added, "In the second quarter, we reopened the Phase 1 study of XmAb14045 to enrollment, and patients have since begun treatment under the amended protocol. We also advanced our second and third TME activating bispecific antibodies into Phase 1 clinical studies. TME bispecific antibodies are designed with tuned dual checkpoint or checkpoint-agonist mechanisms to generate anti-tumor immune responses in a targeted manner. Finally, we continued to strengthen our senior leadership with appointments in business development and regulatory affairs."

Recent Business and Clinical Highlights and Anticipated Upcoming Milestones

CD3 Bispecific Antibodies: Xencor’s initial bispecific antibody programs are tumor-targeted antibodies that contain both a tumor antigen binding domain and a cytotoxic T-cell binding domain (CD3). These bispecific antibodies activate T cells for highly potent and targeted killing of malignant cells.

XmAb14045 (CD123 x CD3): Clinical sites participating in the Phase 1 study in patients with relapsed/refectory acute myeloid leukemia have resumed enrollment, and in early July the first patient was dosed under the study’s amended protocol. Amendments to the protocol included guidance on the monitoring and clinical management of cytokine release syndrome.
XmAb13676 (CD20 x CD3): A Phase 1 dose-escalation study began dosing patients with B-cell malignancies in February 2017. Enrollment in dose-escalation cohorts is ongoing, and initial data are expected in the fourth quarter of 2019.
XmAb18087 (SSTR2 x CD3): A Phase 1 dose-escalation study began dosing patients with neuroendocrine tumors or gastrointestinal stromal tumors in February 2018. Enrollment in dose-escalation cohorts is ongoing, and initial data are expected in the first half of 2020.
Tumor Microenvironment (TME) Activating Bispecific Antibodies: Xencor’s bispecific pipeline includes a suite of TME activators that engage multiple, different targets, such as T-cell checkpoint or agonist receptors. Xencor’s TME activators are designed to promote tumor-selective T-cell activation.

XmAb20717 (PD-1 x CTLA-4):A Phase 1 dose-escalation study in patients with advanced solid tumors began dosing patients in July 2018. Enrollment in dose-escalation cohorts is ongoing, and initial data are expected in the first half of 2020.
XmAb22841 (CTLA-4 x LAG-3): In May 2019, the first patient was dosed in a Phase 1 study evaluating XmAb22841 as a monotherapy and in combination with pembrolizumab in patients with select advanced solid tumors.
XmAb23104 (PD-1 x ICOS):In May 2019, the first patient was dosed in a Phase 1 study in patients with select advanced solid tumors.
Cytokines: Xencor uses its bispecific Fc domain and Xtend technology to engineer cytokines, which are immune signaling proteins, that have potency tuned to improve therapeutic index and have longer half-life.

XmAb24306 (IL15/IL15Rα-Fc fusion protein): The Company will support Genentech’s efforts to submit an IND application for this candidate, which is anticipated in the second half of 2019.
Partnered XmAb Programs: Xencor has eight licensing partnerships for XmAb technology. The most advanced program where the Company has licensed its technology is Alexion’s Ultomiris, which has received marketing authorizations for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) in the U.S. (December 2018), Japan (June 2019) and Europe (July 2019).

Corporate: In June 2019, Xencor announced the planned October 31, 2019 retirement of Paul Foster, M.D., Chief Medical Officer. As the Company searches for Dr. Foster’s successor, Xencor strengthened its senior management team in the second quarter with the appointments of Jeremy Grunstein, Ph.D., as vice president, business development, and Kirk Rosemark, as vice president, regulatory affairs and quality assurance.

Ultomiris is a registered trademark of Alexion Pharmaceuticals, Inc.

Second Quarter Ended June 30, 2019 Financial Results

Cash, cash equivalents and marketable securities totaled $626.1 million as of June 30, 2019, compared to $530.5 million at December 31, 2018. The increase reflects upfront proceeds of $135 million received in the first half of 2019 from the Genentech and Astellas collaborations, offset by cash used to fund operating activities in the first six months of 2019.

Total revenue for the second quarter ended June 30, 2019 was $19.5 million, which was primarily revenue recognized under the Astellas collaboration and a milestone and royalties earned from Alexion. Total revenue for the six months ended June 30, 2019 was $131.4 million and includes revenue earned from the Genentech and Astellas collaborations and the milestone and royalty revenue from Alexion. No revenue was reported for the same periods in 2018.

Research and development expenses for the second quarter of 2019 were $33.3 million, compared to $23.3 million for the same period in 2018. Total research and development expenses for the six months ended June 30, 2019 were $61.5 million, compared to $49.4 million for the same period in 2018. The increased research and development spending for the three and six months ended June 30, 2019 reflects increased stock-based compensation expense and additional spending on Xencor’s CD3 bispecific antibody and cytokine development candidates and technologies.

General and administrative expenses for the second quarter of 2019 were $5.8 million, compared to $5.0 million for the same period in 2018. Total general and administrative expenses for the six months ended June 30, 2019 were $11.3 million, compared to $9.5 million for the same period in 2018. The increased general and administrative spending for the three and six months ended June 30, 2019 reflects additional spending on intellectual property including patents and licensing and additional expenses related to personnel and professional services.

Non-cash, stock-based compensation expense for the six months ended June 30, 2019 was $15.2 million, compared to $9.4 million for the same period in 2018.

Net loss for the second quarter ended June 30, 2019 was $16.0 million, or $(0.28) on a fully diluted per share basis, compared to a net loss of $25.9 million, or $(0.46) on a fully diluted per share basis, for the same period in 2018. For the six months ended June 30, 2019, net income was $64.0 million, or $1.10 on a fully diluted per share basis, compared to a net loss of $55.4 million, or $(1.07) on a fully diluted per share basis, for the same period in 2018. The lower net loss reported for the three months ended June 30, 2019 over the same period in 2018 is primarily due to revenue from our Astellas and Alexion collaborations in 2019. The net income reported for the six months ended June 30, 2019 over the net loss reported for the same period in 2018 is primarily due to revenue recognized from our Genentech collaboration.

The total shares outstanding were 56,529,398 as of June 30, 2019, compared to 55,821,310 as of June 30, 2018.

Financial Guidance

Based on current operating plans, Xencor expects to have cash to fund research and development programs and operations beyond 2024. Xencor expects to end 2019 with between $575 million and $600 million in cash, cash equivalents and marketable securities.

Conference Call and Webcast

Xencor will host a conference call today at 4:30 p.m. ET (1:30 p.m. PT) to discuss these second quarter 2019 financial results and provide a corporate update. The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers and referencing conference ID number 1597118. A live webcast of the conference call will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. The webcast will be archived on the company website for 30 days.

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]).

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"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.

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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]).

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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]).

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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.