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 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform reported that it has entered into a research collaboration with the Karolinska Institutet in Stockholm, Sweden (Press release, RXi Pharmaceuticals, AUG 15, 2018, View Source [SID1234528886]). This collaboration will explore RXi’s sd-rxRNA compounds against targets involved in T cell and NK cell differentiation and/or in the immune cell tumor-induced stress response with the aim of producing anti-tumor adoptive cell therapy grafts with improved functionality and persistence.

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This work will expand on the recently published results from the Kiessling group demonstrating that an sd-rxRNA targeting PD-1 can enhance TIL antitumor activity against melanoma cells in vitro, further showing that ex vivo treatment with the sd-rxRNA compounds was easily incorporated into a clinically relevant rapid expansion protocol for TILs.1

Dr. Gerrit Dispersyn, Chief Development Officer of RXi Pharmaceuticals, stated: "We are pleased to expand our collaboration with Dr. Kiessling’s group, to further harness their expertise in oncology and to expand on the successful research they have previously done with our sd-rxRNA technology platform in immuno-oncology. The combination of their prior results and the anticipated research results from this new collaboration are critical elements for a rapid advancement of sd-rxRNA immuno-oncology therapeutics into the clinic, further supported by our prior clinical experience with sd-rxRNA in other indications."

Rolf Kiessling, MD, PhD, Senior Professor in Experimental Oncology at the Karolinska Institutet, Senior Chief Physician at the Oncology clinic at the Karolinska University Hospital and member of RXi’s Scientific Advisory Board stated: "Our results to date provide direct clinical relevance for the use of sd-rxRNA technology to improve ACT. In this collaboration, we look forward to exploring using sd-rxRNA to modulate targets outside of checkpoints to improve efficacy of immune effector cells such as T cells and NK cells."

Immunotherapy of cancer has become increasingly important in clinical practice over the recent decade. By activating the patient’s immune system, immunotherapy treatments have shown remarkable promise in extending the lifespan of previously untreatable cancer patients. Adoptive cell therapy is an emerging immunotherapy approach which uses immune cells, such as T-lymphocytes or NK cells that are isolated from the patient or retrieved from allogeneic immune cell banks, and then expanded and in some cases processed to express tumor-binding receptors.

A new and important step in this ex-vivo processing of the immune cells is in development where self-delivering RNAi compounds (sd-rxRNA) are used to eliminate the expression of immunosuppressive receptors or proteins from the therapeutic immune cells, thereby making them less sensitive to tumor resistance mechanisms and improving their ability to destroy tumor cells. In this way, sd-rxRNA therapeutic compounds can be used to weaponize therapeutic immune cells to attack cancer and ultimately provide patients battling terminal cancers with a powerful new treatment option that goes beyond current treatment modalities.

About RXi Pharmaceuticals

RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company developing the next generation of immuno-oncology therapeutics based on its self-delivering RNAi (sd-rxRNA) therapeutic platform. The Company’s discovery and research efforts are focused on developing sd-rxRNA therapeutic compounds to be used with an Adoptive Cell Transfer (ACT) approach. This process uses immune cells, such as T-lymphocytes that are isolated from the patient or retrieved from allogeneic immune cell banks, and then expanded and in some cases processed to express tumor-binding receptors. Our approach introduces a new and important step in ex-vivo processing of the immune cells where sd-rxRNA is used to eliminate the expression of immunosuppressive receptors or proteins from the therapeutic immune cells, making them less sensitive to tumor resistance mechanisms and thus improving their ability to destroy the tumor cells. Essentially, we aim to maximize the power of our sd-rxRNA therapeutic compounds by weaponizing therapeutic immune effector cells to attack cancer and ultimately provide patients battling terminal cancers with a powerful new treatment option that goes beyond current treatment modalities.

On August 15, 2018 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported financial results for the quarter ended June 30, 2018 (Press release, Sellas Life Sciences, AUG 15, 2018, View Source [SID1234528887]).

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"During the second quarter of 2018 we made significant progress in laying the foundation for executing on our clinical programs by closing the second tranche of our sale of Series A Preferred Stock and warrants and commencing the process for a follow-on equity offering. We are pleased to have closed that equity financing last month which, together with the proceeds from the sale of the preferred stock and warrants, provides us with funding to begin to advance our pipeline of novel cancer immunotherapies, focusing first on galinpepimut-S (GPS)," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We plan to initiate our Phase 1/2 basket trial of GPS in combination with Keytruda in a number of indications by the end of the third quarter with the first patient in during the fourth quarter and are actively finalizing our clinical plan for a Phase 3 study of GPS in patients with acute myeloid leukemia. Looking ahead, we are also excited to present our Phase 2b data of Herceptin +/- NeuVax in an oral presentation at the 2018 Annual Meeting of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in late October as well as optimizing our regulatory strategy for NeuVax with U.S. and European regulatory authorities and exploring strategic partnering alternatives around NeuVax," continued Dr. Stergiou.

Second Quarter 2018 and Recent Business Highlights

In July 2018, SELLAS completed an underwritten public offering of common stock and pre-funded warrants, together with accompanying common stock warrants, for aggregate net proceeds of approximately $21.6 million, after deducting underwriting discounts, commissions and offering expenses.
In July 2018, SELLAS announced that data on the adjuvant treatment of women with triple-negative breast cancer (TNBC) with the combination of trastuzumab (Herceptin) +/- NeuVax from a Phase 2b independent investigator-sponsored trial (IST) will be presented at the 2018 ESMO (Free ESMO Whitepaper) Annual Meeting October 19-23 in Munich, Germany.
In July 2018, SELLAS announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to GPS for the treatment of multiple myeloma (MM).
In June 2018, SELLAS presented interim data from an open-label Phase 1 IST of GPS in combination with nivolumab in patients with Wilms Tumor 1 (WT1)+ ovarian cancer in second or third remission after salvage chemotherapy at the 2018 annual meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Exploratory efficacy interim data showed that GPS, when combined with a PD-1 inhibitor, demonstrated a progression-free survival rate of 64% at one year in an intent to treat group of 11 evaluable patients with WT1+ ovarian cancer in second or greater remission. Among patients who received at least three doses of GPS in combination with nivolumab, PFS at one year was 70% (7/10). The historical rates with best standard treatment do not exceed 50% in this disease setting.
In June 2018, SELLAS announced that the Phase 2b independent IST of Herceptin +/- NeuVax in HER2 1+/2+ breast cancer patients achieved its key clinical development objectives and was being discontinued, based in part on the recommendation of the independent Data Safety Monitoring Board to further develop the NeuVax + Herceptin combination for patients with TNBC.
In June 2018, the Company was issued U.S. Patent No. 9,993,538 which is a method of use patent that is part of the patent portfolio for the GALE-301 and GALE-302 folate binding protein derived peptides. The method claims cover a dosing regimen to induce an immune response against a tumor expressing folate receptor alpha (FR-alpha) using the GALE-301 peptide (peptide of FR-alpha epitope E39) and the GALE-302 peptide booster (peptide of FR-alpha epitope E39’). The patent will expire on May 31, 2036 and provides further patent protection on the initial GALE-302 patent family, which expires in 2022.
In May 2018, SELLAS announced that the FDA granted orphan drug designation to GPS for the treatment of MM.
In May 2018, SELLAS completed the second tranche of its $10.7 million private placement transaction.
In April 2018, SELLAS appointed Gene Mack as Chief Financial Officer and Treasurer.
Second Quarter 2018 Financial Results

For accounting purposes, SELLAS Life Sciences Group Ltd., a private Bermuda exempted company (SELLAS Ltd.), is considered to have acquired the Company (which was formerly known as Galena Biopharma, Inc. (Galena)) in the business combination between SELLAS Ltd. and Galena (the Merger); therefore, upon the Merger, the financial statements of Galena became those of SELLAS Ltd. and the results reported are those of SELLAS Ltd. reflecting the acquisition of Galena as of December 29, 2017.

Cash Position: As of June 30, 2018, cash and cash equivalents were $1.3 million, compared to $2.3 million as of December 31, 2017. Net cash used in operating activities was $11.7 million for the first half of 2018, partially offset by $8.9 million of net cash provided by financing activities. On July 16, 2018, SELLAS completed an underwritten public offering of common stock and pre-funded warrants, together with accompanying common stock warrants, for aggregate net proceeds of approximately $21.6 million, after deducting underwriting discounts, commissions and offering expenses.

R&D Expenses: Research and development expenses were $1.6 million for the second quarter of 2018, as compared to $1.8 million for the second quarter of 2017. The decrease was primarily attributable to a decrease in licensing fees, partially offset by a severance charge and an increase in clinical and regulatory consulting services. Research and development expenses for the six months ended June 30, 2018 were $3.4 million, as compared to $4.0 million for the same period in 2017. The decrease was primarily attributable to a decrease in licensing fees.

G&A Expenses: General and administrative expenses were $4.9 million for the second quarter of 2018, as compared to $3.8 million for the second quarter of 2017. The increase was primarily driven by an increase in legal fees related to ongoing litigation and other legal matters related to Galena’s business and operations, personnel related expenses and an increase in insurance premiums. These increases were partially offset by a decrease in stock-based compensation expense. General and administrative expenses for the first half of 2018 were $8.8 million, as compared to $6.1 for the six months ended June 30, 2017. The increase during the period was primarily related to legal and advisory fees associated with the Merger with Galena and ongoing litigation and other legal matters related to Galena’s business and operations.

Net Loss: Net loss attributable to common stockholders was $8.5 million for the second quarter of 2018, or a basic and diluted loss per share attributable to common stockholders of $1.26, as compared to a net loss attributable to common stockholders of $5.9 million for the second quarter of 2017, or a basic and diluted loss per share attributable to common stockholders of $4.50. Net loss attributable to common stockholders was $18.5 million for the six months ended June 30, 2018, or a basic and diluted loss per share attributable to common stockholders of $2.89, as compared to a net loss attributable to common stockholders of $10.5 million for the prior period, or a basic and diluted loss per share attributable to common stockholders of $8.14.

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 14, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the second quarter ended June 30, 2018 (Press release, Heat Biologics, AUG 14, 2018, View Source [SID1234528875]).

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Jeff Wolf, Heat’s CEO, commented, "Earlier this year we reported positive interim results from our Phase 2 trial investigating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced non-small cell lung cancer (NSCLC). Since then, we have continued to execute on our clinical plan and remain on track to report additional interim Phase 2 data in the fourth quarter of 2018 and to complete trial enrollment in Q2 2019."

"In addition to our Phase 2 HS-110 program, we look forward to filing our Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for our ComPACT trial in the fourth quarter of 2018. Our ComPACT therapy combines T-cell activators and co-stimulators within a single treatment, simplifying combination immunotherapy while providing superior immune activation and reduced treatment costs."

"Finally, we look forward to filing our second Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for PTX-35, a novel co-stimulatory monoclonal antibody, in the first quarter of 2019. Each of our therapies is designed to enhance the response rate for patients least likely to respond to checkpoint inhibitors through a combination treatment that enhances the immune defense mechanisms."

"Importantly, we completed a capital raise of $20.7 million in the second quarter of 2018. In addition, we have subsequently generated an additional $4.8 million through the exercise of warrants. These funds, combined with the additional $6.9 million in CPRIT grant funds for PTX-35, which we expect to receive in the third quarter of this year, should provide us sufficient capital to advance our clinical programs and achieve a number of major milestones through the end of 2019."

Second Quarter 2018 Corporate Highlights

On April 18, 2018, Heat Biologics released guidance regarding major upcoming milestones through Q3, 2019.
On May 7, 2018, Heat Biologics announced the closing of $20.7 million public offering.
Second Quarter 2018 Financial Results

Recognized $1.1 million of grant revenue for qualified expenditures under the CPRIT grant.
Research and development expenses increased approximately 59.1% to $3.5 million for the quarter ended June 30, 2018 compared to $2.2 million for the quarter ended June 30, 2017. The $1.3 million increase is due in part to PTX expenses, as the Company began pre-clinical development of PTX-35 and PTX-15 against TNFRSF25 for testing in patients.
General and administrative expense decreased approximately 12.5% to $1.4 million for the quarter ended June 30, 2018 compared to $1.6 million for the quarter ended June 30, 2017. The $0.2 million decrease is primarily attributable to the acquisition costs of the Pelican subsidiary during the three months ended June 30, 2017.
Net loss attributable to Heat Biologics was approximately $4.1 million, or ($0.27) per basic and diluted share for the quarter ended June 30, 2018 compared to a net loss of approximately $3.2 million, or ($0.91) per basic and diluted share for the quarter ended June 30, 2017.
As of June 30, 2018, the Company had approximately $24.7 million in cash and cash equivalents.