On August 16, 2018 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the second quarter ended June 30, 2018 and provided a corporate update (Press release, VBL Therapeutics, AUG 16, 2018, View Source [SID1234528950]).

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"VBL is well capitalized, with more than $58 million in cash, which will enable us to continue the development of VB-111 in ovarian cancer, and to advance our innovative pipeline, including our exciting VB-600 platform targeting MOSPD2, for more than the next three years," said Dror Harats M.D., Chief Executive Officer of VBL Therapeutics.

"We continue to have high conviction in the promise of VB-111 and are focused on executing the ongoing Phase 3 OVAL trial, evaluating VB-111 in platinum-resistant ovarian cancer. We plan to conduct an interim efficacy analysis of this trial in the fourth quarter of 2019."

"We are excited about our MOSPD2 platform and are very encouraged by the emerging data which highlights the potential of this novel target in the treatment of both cancer and inflammatory disease such as multiple sclerosis. Our goal is to file the first IND from this program by year-end 2019," continued Prof. Harats.

VBL will present more data on MOSPD2 at the European Committee for Treatment and Research in Multiple Sclerosis (or ECTRIMS) conference on October 11th in Berlin.

Second Quarter and Recent Corporate Highlights:

Closed a $15.5 million registered direct offering, which will enable the Company to continue the development of VB-111 in ovarian cancer, and to advance the pipeline, including the VB-600 platform targeting MOSPD2, for the next three years.

Continued to treat patients in the ongoing Phase 3 OVAL trial, evaluating VB-111 in platinum-resistant ovarian cancer. An efficacy interim readout is expected to occur in the fourth quarter of 2019.

Conducted analyses of the VB-111 Phase 3 GLOBE trial in recurrent glioblastoma (rGBM). We are particularly investigating the possibility that the treatment regimen of the GLOBE trial, which was performed under a pre-agreed Special Protocol Assessment (SPA), may have impaired the activity of VB-111. Our analyses have not revealed any other risk factor that can explain the difference in outcome compared with the prior Phase 2 trial. The Company plans to present additional data on GLOBE at the Society for Neuro-Oncology, or SNO meeting, in November 2018.
Presented positive new data on the Company’s MOSPD2 platform technology in oncology and inflammation in international conferences, and published a paper highlighting MOSPD2 as a potential new target for therapy of solid tumors such as breast cancer.

° Presented a late-breaking study demonstrating a novel bi-specific antibody that induces immune-cell mediated killing of cancer cells through binding to a tumor membrane receptor, MOSPD2, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 annual meeting.

° Presented data on the role of MOSPD2 in oncology and inflammation at the 2018 BIO international convention. VBL research has shown that knocking out the MOSPD2 gene in mice can protect the animals from developing certain inflammatory diseases. The Company has generated antibodies that block immune cell migration and show efficacy in a model of multiple sclerosis.

° A paper published in the International Journal of Cancerfeatured VBL data showing that MOSPD2 can play a major role in breast cancer cell migration and metastasis, and that targeting MOSPD2 may be a viable therapeutic strategy to prevent the spreading of breast cancer cells. VBL’s data indicate that knock-out of MOSPD2 in tumor cells may reduce metastasis by up to 95% in certain settings.

° VBL is developing the VB-600-MOSPD2 platform of biologic drug candidates for oncology and inflammatory indications. The Company plans to file the first IND in this program by year-end 2019.
Second Quarter Ended June 30, 2018 Financial Results:

Revenues: revenues related to our collaboration in Japan in the amount of $0.2 million were recognized in the period.

Cash Position: Cash, cash equivalents and short-term bank deposits at June 30, 2018, were $58.5 million. Working capital at June 30 was $54.7 million. The Company estimates that, based on current projections, the current cash, cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements for more than 3 years.

R&D Expenses: Research and development expenses for the quarter ended June 30, 2018, were approximately $2.9 million, compared to approximately $3.2 million in the comparable period in 2017. R&D expenses are shown net of grants from the Israel Innovation Authority (IIA).

G&A Expenses: General and administrative expenses for the quarter ended June 30, 2018 were $1.2 million, compared to $1.9 million for the comparable period in 2017.

Comprehensive Loss: The Company reported a comprehensive loss for second quarter ended June 30, 2018 of $4.1 million, or ($0.13) per share, compared to a net loss of $4.9 million, or ($0.18) per share in second quarter ended June 30, 2017.

Conference Call:

Thursday, August 16th @ 8:30am Eastern Time
US Domestic: 877-222-6394
International: 703-925-2702
Conference ID: 3572709
Webcast: View Source

Replays, Available through August 30, 2018
US Domestic: 855-859-2056
International: 404-537-3406
Conference ID: 3572709

On August 16, 2018 Synthorx, Inc., a biotechnology company using a first-of-its-kind Expanded Genetic Alphabet platform to discover and develop innovative protein therapeutics for cancer, autoimmune disorders and other serious diseases, reported the appointment of Joseph Leveque, M.D., as chief medical officer (Press release, Synthorx, AUG 16, 2018, View Source [SID1234528935]). Dr. Leveque brings over 20 years of biotechnology management and therapeutic development experience to Synthorx, with a particular focus on immuno-oncology (IO).

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"Dr. Leveque joins us with a deep-rooted knowledge of the immuno-oncology space, notably with his experience at ARMO BioSciences leading the pivotal Phase 3 trials of the company’s lead IO drug candidate, as well as his involvement in the development and commercialization of Opdivo, Yervoy, and Bavencio, during his time at Bristol-Myers Squibb and Merck KGaA," said Laura Shawver, Ph.D., chief executive officer of Synthorx. "Dr. Leveque is an invaluable addition to our leadership team as we advance our Synthorin cytokine pipeline, including moving our IL-2 Synthorins into clinical trials, where we expect to demonstrate proof of clinical activity in our initial studies in oncology and autoimmune indications."

Dr. Leveque joins Synthorx from his previous role as chief medical officer of ARMO BioSciences, a late-stage immuno-oncology company that was acquired by Eli Lilly in May 2018. Prior to this, he was chief medical officer of EMD Serono, the North American subsidiary of Merck KGaA and the vice president and head of U.S. medical oncology at Bristol-Myers Squibb, where he was involved in the development and commercialization of the first generation of immuno-oncology therapeutics. Before his role at Bristol-Myers Squibb, Dr. Leveque was the vice president of medical and scientific affairs at Onyx Pharmaceuticals. Earlier in his career, he served as vice president of medical and scientific affairs at Cephalon Oncology and as medical director at Amgen, where he worked on several therapeutic programs for solid tumor and hematological malignancies.

Dr. Leveque earned a Medical Doctorate from The University of Texas School of Medicine in Houston, TX and completed his post-graduate medical training in internal medicine at the Cedars-Sinai Medical Center, a teaching affiliate of the University of California, Los Angeles (UCLA). In addition, Dr. Leveque holds a Master of Business Administration from the Wharton School of the University of Pennsylvania.

On August 15, 2018 Crescendo Biologics Ltd (Crescendo), the developer of targeted T-cell engagers, reported that it has achieved another technical milestone in its collaboration with Takeda Pharmaceutical Company Limited (Takeda) (Press release, Crescendo Biologics, AUG 15, 2018, View Source [SID1234528994]).

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Crescendo’s global, strategic, multi-target collaboration and license agreement with Takeda was announced in October 2016. Under this agreement, Crescendo’s proprietary transgenic platform and engineering expertise is used to identify and configure Humabody-based therapeutics against certain targets selected by Takeda.

This milestone, for an undisclosed amount, marks the successful delivery of another highly diverse panel of functional Humabody leads against the second of Takeda’s selected targets. The achievement of an equivalent milestone related to the first of Takeda’s selected targets was announced in April 2018.

Dr Peter Pack, CEO of Crescendo, commented:

"Crescendo has once again demonstrated its ability to deliver, ahead of schedule, a diverse selection of functional Humabody molecules meeting the stringent specifications outlined in the collaboration agreement.

"Our highly productive relationship draws together Takeda’s deep oncology experience with Crescendo’s expertise in developing optimally configured Humabodies. Together we are fast progressing towards our goal of developing next generation, highly modular and multi-functional biologics against cancer. This is another important step forward for Crescendo and further validates the power of our innovative technology."

On August 15, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported its financial results for the quarter ended June 30, 2018 (Press release, Delcath Systems, AUG 15, 2018, View Source;p=RssLanding&cat=news&id=2363736 [SID1234528978]).

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Highlights from the second quarter of 2018 and recent weeks include:

Amendment of the Company’s ongoing Phase 3 clinical trial in ocular melanoma liver metastases to a non-randomized, single-arm trial
Initiation of a $50 million rights offering
Revenue from European sales for the quarter of approximately $0.9 million;
100th CHEMOSAT treatment performed at Leiden University Medical Center;
Inclusion of CHEMOSAT in the German national treatment guidelines for liver metastases from melanoma.
Announcement that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 FOCUS clinical trial has again recommended that the study continue without modification;
Initiation of the ALIGN registration trial for the treatment of Intrahepatic Cholangiocarcinoma (ICC);
CHEMOSAT featured in main stage training presentation at European Conference on Interventional Oncology;
Management Commentary

"During our second quarter we continued to advance the major elements of our Clinical Development Program while taking steps to resolve the cash constraints and other restrictions that have impeded our ability to operate in recent weeks," said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. "These efforts culminated with the announcements we made in July of the protocol amendment to our ongoing FOCUS Phase 3 trial in ocular melanoma liver metastases to permit a non-randomized single-arm study, and our $50 million rights offering. These are highly significant developments for Delcath, and together provide both a path toward an application for FDA approval and the necessary financing to achieve it."

"Revenues for the second quarter of 2018 were approximately $0.9 million, an increase of nearly 50% over approximately $0.6 million in the prior year quarter. During the quarter, we announced CHEMOSAT was included in the German national treatment guidelines for ocular melanoma liver metastases, and that our third European commercial treatment center achieved the 100-treatment milestone. To date centers in Europe have completed over 600 CHEMOSAT treatments. CHEMOSAT was also featured in a main state presentation at the ECIO annual meeting, demonstrating the continued interest in the European research community in PHP therapy’s potential.

"Regarding our FOCUS Phase 3 Trial, in addition to the protocol amendment we announced in May that the independent Data Safety Monitoring Board (DSMB) has completed another review of safety data for treated patients in the trial and again recommended that the study continue without safety related modification. Safety data for the amended trial will be pooled with all patients treated with Melphalan/HDS under the prior protocol.

"During the second quarter, we announced the initiation of our registration trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with intrahepatic cholangiocarcinoma (ICC). Called The ALIGN Trial, this trial will seek to enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe. The trial is being conducted under a Special Protocol Assessment (SPA) agreement reached with the U.S. Food and Drug Administration (FDA) in March 2017. The ALIGN Trial is based on a strong efficacy signal observed in the ICC tumor type through our commercial experience with CHEMOSAT in Europe. We are leveraging our existing network of trial sites from our FOCUS Phase 3 trial to rollout the trial protocol as efficiently as possible and have 3 centers open for patient enrollment to date. In this orphan population where there exists a huge unmet need, this trial provides us with a second pathway to commercial drug approval in the United States, and if successful we believe will be an important value driver for the Company.

"Though the recent months have been difficult we have taken significant steps to reduce our time to NDA submission, advance our clinical and commercial programs, and obtain the financial resources required to realize PHP therapy’s potential and return value to our shareholders," concluded Dr. Simpson.

Second Quarter 2018 Financial Results

Revenue for the three months ended June 30, 2018 was $0.9 million, up from $0.6 million for the prior year period driven by the establishment of reimbursement coverage of CHEMOSAT procedures in Germany. Selling, general and administrative expenses were approximately $2.6 million compared to $2.5 million in the prior year quarter, a slight increase related to decreased production and adjustments to overhead allocations. Research and development expenses for the current quarter increased to $4.1 million from $2.5 million in the prior year quarter, driven by increased costs associated primarily due to the ongoing accrual of the Company’s Phase 3 FOCUS trial. Total operating expenses for the current quarter were $6.7 million compared with $5.1 million in the prior year quarter.

The Company recorded net loss for the three months ended June 30, 2018, of $6.7 million, an increase of $4.7 million, or 242.6%, compared to a net loss of $1.9 million for the same period in 2017. This increase in net loss is primarily due to a $6.7 million decrease in interest expense primarily related to the amortization of debt discounts related to convertible notes that were fully satisfied in 2017, and a $2.6 million increase in the change in the fair value of the warrant liability, both non-cash items. Additionally, there was a $1.7 million increase in operating expenses primarily related to increased investment in our clinical trial initiatives.

Balance Sheet Highlights
At June 30, 2018, the Company had cash and cash equivalents totaling $1.3 million, as compared to cash and cash equivalents totaling $4.0 million at December 31, 2017 and $1.8 million at June 30, 2017. During the six months ended June 30, 2018 and June 30, 2017, the Company used $9.3 million and $8.1 million respectively, of cash in its operating activities. The Company believes that its capital resources are adequate to fund its operating activities through August 2018.

On June 4, 2018, the Company entered into a Securities Purchase Agreement (the "SPA") with an institutional investor pursuant to which the Company issued $3.3 million in principal face amount of senior secured convertible notes of the Company (the "Notes") and related Series D Warrants (the "Series D Warrants") to purchase additional shares of the Company’s common stock ("Common Stock"). $3.3 million of the Notes were issued for cash proceeds of $2.4 million with an original issue discount in the amount of $1.1 million.

On July 20, 2018, the Company entered into a Securities Purchase Agreement with another institutional investor for the remaining Notes and Warrants in proportionate amounts to those issued in the June 4, 2018 transaction which is discussed in Note 7, in a transaction exempt from registration pursuant to Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder, and received gross proceeds of $1,600,000.

Rights Offering & Bridge Financing

On July 16, 2018 the Company filed a registration statement on Form S-1 with the SEC for a rights offering for up to 28,571,429 shares of common stock at the subscription price of $1.75 per share. The subscription period this rights offering began on Tuesday, August 7, 2018 upon declaration of effectiveness of its registration statement on Form S-1 by the SEC.

On August 15, 2018 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies1, reported that Merck, known as MSD outside the United States and Canada, initiated a Phase I clinical trial of an undisclosed antibody candidate discovered by Agenus, under the two companies license and research collaboration (Press release, Agenus, AUG 15, 2018, View Source [SID1234528898]). Based on this milestone and under the terms of the agreement, Agenus received a $4 million milestone payment and is entitled to receive up to an additional $95 million in success milestones from Merck.

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"We continue to deliver on all milestones with our existing partners." said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "This is yet another validation of our antibody discovery platform and expertise in the field and adds to our successes in delivering first in class discoveries to patients. Notably, besides this, we also have two other partnered programs advancing to the clinic this year, each triggering additional milestone payments to Agenus."

This milestone is the second under the collaboration, originally announced in April 2014. According to the terms of the agreement, Merck is responsible for all product development expenses for the antibody candidate, and Agenus is eligible to receive up to an additional $95 million in milestone payments, as well as royalties on worldwide product sales.