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Fate Therapeutics Reports Second Quarter 2017 Financial Results

On August 14, 2017 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported business highlights and financial results for the second quarter ended June 30, 2017 (Filing, 8-K, Fate Therapeutics, AUG 14, 2017, View Source [SID1234520243]).

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"Clinical momentum across our first-in-class cellular immunotherapy programs continues to accelerate. The first subject was treated with FATE-NK100 in VOYAGE for AML, and we look forward to opening two additional clinical trials of FATE-NK100 for the treatment of multiple advanced solid tumor types including in combination with monoclonal antibody therapy," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "Our productive discussions with the FDA continue regarding the advancement of our proprietary iPSC-derived cancer immunotherapy pipeline toward first-in-human studies. We currently remain on-track to file, in the first quarter of 2018, an investigational new drug application with the FDA for FT500i, a first-of-kind natural killer cell product candidate derived from a master pluripotent cell line. We are also prepared to initiate enrollment in the Phase 2 efficacy stage of PROTECT next month. Six subjects received ProTmune and we have convened the study’s data monitoring committee to review the Phase 1 data."

Recent Highlights & Program Updates

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Convened PROTECT Data Monitoring Committee for ProTmune Phase 1 Review. The first six subjects in the Phase 1 safety stage of PROTECT received ProTmune, the Company’s next-generation cell graft for the prevention of acute graft-versus-host disease. The Company has convened the study’s data monitoring committee to seek its recommendation regarding the initiation of the Phase 2 efficacy stage. Following the committee’s Phase 1 data review, Fate Therapeutics plans to begin enrolling the randomized, controlled and blinded Phase 2 efficacy stage of PROTECT in adult subjects with hematologic malignancies undergoing matched unrelated donor transplant during the third quarter of 2017.

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First Subject Treated with FATE-NK100 in VOYAGE for AML. The Company’s first-in-class adaptive memory natural killer (NK) cell product candidate, FATE-NK100, was administered to the first subject in VOYAGE, an open-label dose-escalation clinical trial for the treatment of refractory or relapsed acute myelogenous leukemia (AML). VOYAGE is evaluating the safety and the in vivo persistence at Day 7 and Day 14 of a single intravenous infusion of FATE-NK100. The anti-tumor activity of FATE-NK100 as measured by rates of complete response at 42 days post-infusion and clearance of minimal residual disease is also being assessed.

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IND Cleared by FDA for FATE-NK100 in Ovarian Cancer. The U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application of FATE-NK100 for the treatment of women with ovarian cancer resistant to, or recurrent on, platinum-based treatment. The study is designed to evaluate the safety and determine the maximum dose of a single infusion of FATE-NK100 when administered directly into the peritoneum in an outpatient setting. Intraperitoneal delivery of NK cells is a novel strategy intended to promote co-localization with tumor cells and maximize NK cell persistence. Other study endpoints include objective response rate at 28 days post-infusion and progression-free and overall survival.

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IND Cleared by FDA for FATE-NK100 in Advanced Solid Tumors. In May 2017, the FDA cleared the Company’s IND application for the clinical investigation of FATE-NK100, including in combination with monoclonal antibody therapy, in subjects with advanced solid tumor malignancies. The Company is preparing to enroll the DIMENSION study, which is designed to evaluate the safety and anti-tumor activity of FATE-NK100 in the outpatient setting across three treatment arms: as monotherapy for small cell lung cancer and hepatocellular carcinoma; in combination with trastuzumab for advanced HER2+ breast and gastric cancers; and in combination with cetuximab for advanced EGFR1+ colorectal and head and neck cancers.

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Showcased First-of-Kind NK Cell Cancer Immunotherapy Pipeline at 2017 ISSCR. In June 2017, Fate Therapeutics, along with its collaborators, presented new preclinical data on the Company’s proprietary induced pluripotent stem cell (iPSC) platform and its iPSC-derived cancer immunotherapy candidates at the 2017 Annual Meeting of the International Society for Stem Cell Research (ISSCR). The Company expects to file an IND with the FDA during the first quarter of 2018 for FT500i, a first-of-kind iPSC-derived NK cell product candidate for the treatment of advanced solid tumors including in combination with checkpoint inhibitors. The session also featured the Company’s second iPSC-derived NK cell product candidate FT516i, which is derived from a master engineered pluripotent cell line expressing a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor.

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Extended Cash Runway through Loan Amendment. In July 2017, Fate Therapeutics amended its loan agreement with Silicon Valley Bank pursuant to which the Company repaid its existing debt obligations in full and entered into a new $15.0 million term loan. Cash proceeds to the Company after repayment of its existing debt obligations were $7.5 million. Under the new term loan, only payments of interest are owed through January 1, 2019, after which time the Company will repay principal plus interest in 30 monthly installments.

Second Quarter 2017 Financial Results

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Cash & Short-term Investment Position: Cash, cash equivalents and short-term investments as of June 30, 2017 were $71.0 million compared to $92.1 million as of December 31, 2016. The decrease was primarily driven by the Company’s use of cash to fund operating activities and to service principal and interest obligations under its loan agreement with Silicon Valley Bank. This balance as of June 30, 2017 did not include $7.5 million in cash proceeds received by the Company in July 2017 in connection with the amendment of its loan agreement with Silicon Valley Bank.

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Total Revenue: Revenue was $1.0 million for the second quarter of 2017 and as well as for the comparable period in 2016. All revenue was derived from the Company’s research collaboration and license agreement with Juno Therapeutics.

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Total Operating Expenses: Total operating expenses were $10.6 million for the second quarter of 2017 compared to $9.0 million for the comparable period in 2016. Operating expenses for the second quarter of 2017 included $1.0 million of stock compensation expense, compared to $0.8 million for the comparable period in 2016.

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R&D Expenses: Research and development expenses were $7.9 million for the second quarter of 2017 compared to $6.8 million for the comparable period in 2016. The increase in R&D expenses was primarily related to an increase in third-party service provider fees to support the clinical development of ProTmune and FATE-NK100 and the preclinical advancement of the Company’s off-the-shelf iPSC-derived cellular immunotherapy programs, and in facilities costs associated with the expansion of the Company’s laboratory space.

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G&A Expenses: General and administrative expenses were $2.7 million for the second quarter of 2017 compared to $2.2 million for the comparable period in 2016. The increase in G&A expenses was primarily related to an increase in intellectual property-related expenses.

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Shares Outstanding: Common shares outstanding as of June 30, 2017 and December 31, 2016 were 41.4 million. Preferred shares outstanding as of June 30, 2017 and December 31, 2016 were 2.82 million, each of which is convertible into five shares of common stock. All preferred shares outstanding are from the Company’s sale and issuance of non-voting Class A convertible preferred stock to Redmile Group, LLC in November 2016.

ImmunoCellular Therapeutics Announces Second Quarter 2017 Financial Results

On August 14, 2017 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported financial results for the second quarter 2017 (Press release, ImmunoCellular Therapeutics, AUG 14, 2017, View Source [SID1234520235]).

For the quarter ended June 30, 2017, ImmunoCellular incurred a net loss of $3.6 million, or $1.02 per basic and diluted share, compared to a net loss of $5.3 million, or $2.30 per basic and diluted share, for the quarter ended June 30, 2016.

For the quarter ended June 30, 2017, research and development expenses were $10.4 million compared to $4.4 million during the quarter ended June 30, 2016. The increase reflects additional patients enrolled in the Company’s phase 3 trial of ICT-107. The Company suspended this trial in June, and wrote off approximately $2.3 million of trial-related supplies and accrued approximately $3 million of expenses to wind down the trial.

During the quarter ended June 30, 2017, ImmunoCellular also recorded a credit of $7.7 million to account for the forgiveness of debt related to the CIRM award. This represents $5.5 million of funds advanced by CIRM for the phase 3 ICT-107 trial and the reversal of $2.2 million of accrued interest.

For the six months ended June 30, 2017, the Company incurred a net loss of $9.4 million, or $2.66 per basic and dilution share, compared to a loss of $11.0 million, or $4.76 per basic and diluted share during the same period in the prior year.

For the six months ended June 30, 2017, research and development expenses were $15.0 million compared to $9.2 million during the six months ended June 30, 2016. The increase reflects additional patients enrolled in the Company’s phase 3 trial of ICT-107 and the write-off of $2.3 million of trial related supplies and the accrual of approximately $3.0 million of expenses to wind down the trial.

The Company used $9.5 million of cash in operations for the six months ended June 30, 2017, compared to $11.2 million for the six months ended June 30, 2016. During the six months ended June 30, 2017, the Company reduced its vendor payments to conserve cash. As a result, accounts payable increased by $2.8 million. With the termination of the phase 3 trial of ICT-107, the Company expects future cash needs will decrease.

During the six months ended June 30, 2017, the Company incurred $3.6 million of non-cash expenses consisting of $30,000 of depreciation and $300,000 of stock based compensation and $2.4 million write-off of trial related supplies and $900,000 of accrued interest on the CIRM award. The Company also recorded non-cash credits of $8.3 million consisting of $7.7 million forgiveness of debt and $550,000 related to the revaluation of warrant derivatives. During the six months ended June 30, 2016, the Company incurred $1.1 million of non-cash expenses consisting of $500,000 of accrued interest on the CIRM award, $40,000 of depreciation, $30,000 of financing expenses and $500,000 of stock based compensation. The Company also recorded a non-cash credit of $900,000 related to the revaluation of warrant derivatives. As of June 30, 2017, the Company had $1.8 million of cash and 3.6 million shares of common stock issued and outstanding.

During the second quarter, the Company announced the wind down of the phase 3 registration trial of ICT-107 in newly diagnosed glioblastoma, while also seeking collaborative relationships relative to its pipeline of clinical-stage dendritic cell-based programs. The Company is focusing on financing and strategic alternatives for its immuno-oncology research and development pipeline and technology platform, which may include a potential merger, consolidation, reorganization or other business combination, as well as the sale of the Company or the Company’s assets.

As previously disclosed, in June, ImmunoCellular received a Deficiency Letter indicating that the Company is not in compliance with the stockholder’s equity requirement of the NYSE MKT Company Guide. As required, the Company submitted a plan to the NYSE MKT advising of actions it plans to undertake, to regain compliance with the continued listing standards by December 23, 2018. The Company is awaiting response from the NYSE MKT to its plan, elements of which included financing and restructuring of operations. If the Company’s plan is not accepted or if the Company fails to regain compliance by December 23, 2018, the NYSE MKT may commence delisting procedures.

In July 2017, ImmunoCellular completed the first tranche of a financing that provided $5 million in gross proceeds from the sale of convertible preferred stock, with the potential to secure an additional $9 million in funding from the exercise of warrants in the financing transaction over the next 12 months. Any additional proceeds in excess of the initial $5 million are dependent on the exercise of the warrants. Proceeds from the financing are being used to move forward with a restructuring plan focused on winding down ICT-107 activities and advancing early-stage research programs while continuing to seek partnership opportunities for development-stage assets.

Heat Biologics Inc. Reports Second Quarter 2017 Results

On August 14, 2017 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company focused on developing immuno-oncology therapies to activate a patient’s immune response against cancer, reported financial and clinical updates for the second quarter ending June 30, 2017 (Press release, Heat Biologics, AUG 14, 2017, View Source [SID1234520233]).

CASI PHARMACEUTICALS REPORTS SECOND QUARTER 2017 FINANCIAL RESULTS

On August 14, 2017 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, reported financial results for the three and six months ended June 30, 2017 (Filing, Q2, CASI Pharmaceuticals, 2017, AUG 14, 2017, View Source [SID1234520226]).

As of June 30, 2017, CASI had cash and cash equivalents of approximately $23.4 million.

CASI reported a net loss for the second quarter of 2017 of ($2.4 million), or ($0.04) per share. This compares to a net loss of ($3.3 million), or ($0.08) per share, for the same period last year. For the six months ended June 30, 2017, the Company reported a net loss of ($4.1 million), or ($0.07) per share, compared to a net loss of ($5.1 million), or ($0.12) per share, for the same period in 2016. The smaller net loss for the three and six month periods in 2017 can be attributed to a decrease in non-cash compensation expense associated with the timing of stock option issuances, offset by an increase in costs related to the China Food and Drug Administration (CFDA) regulatory process of our in-licensed U.S. Food and Drug Administration (FDA) approved assets from Spectrum Pharmaceuticals.

Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, stated, "We continue to effectively manage our expenses and are pleased to end the quarter with a strong cash position. For the balance of 2017, we will continue to advance MARQIBO, ZEVALIN and EVOMELA closer towards marketing approval in China, evaluate our maturing clinical data and determine the next steps for ENMD-2076, while at the same time continue our business development activities to further expand our pipeline."

Asterias Biotherapeutics Reports Second Quarter Financial Results and Reviews Recent Clinical Progress and Corporate Developments

On August 14, 2017 Asterias Biotherapeutics, Inc. (NYSE MKT:AST), a biotechnology company pioneering the field of regenerative medicine, reported financial and operational results for the quarter ended June 30, 2017, as well as recent corporate progress (Press release, BioTime, AUG 14, 2017, View Source [SID1234520224]).

"We made significant progress during the second quarter and in recent months in our two lead development programs: our AST-OPC1 program in spinal cord injury and our AST-VAC2 cancer immunotherapy program in non-small cell lung cancer," said Mike Mulroy, President and Chief Executive Officer of Asterias. "We reported encouraging data from our SCiStar study that shows meaningful improvements in arm, hand, and finger function in patients with severe cervical spinal cord injuries. Importantly, these improvements have been sustained—and in some cases further improved—at nine months following administration of AST-OPC1. In our cancer immunotherapy program, we recently completed a major step toward advancing AST-VAC2 into the clinic. In particular, together with our research partner Cancer Research UK, we successfully completed the production of the first cGMP clinical grade lot of AST-VAC2. This lot of AST-VAC2 provides the initial clinical trial material for patients enrolling in the upcoming clinical study evaluating AST-VAC2 in non-small cell lung cancer. Lastly, we continue to be mindful of our cost structure as we advance our programs and make adjustments to our operating expenses where appropriate."

2017 Upcoming Milestones

In late third quarter or early fourth quarter of 2017, Asterias will report 12-month data from the AIS-A 10 million cell cohort in the SCiStar Phase 1/2a clinical study of AST-OPC1 in complete cervical spinal cord injury.
Asterias expects to complete patient enrollment with a total of between 25-30 subjects in the SCiStar study by the end of 2017.
In the second half of 2017, Asterias expects to have all necessary regulatory clearances to commence the first clinical study of the company’s cancer immunotherapy product candidate AST-VAC2 in non-small cell lung cancer.
By the end of 2017, Asterias expects to have up to three sites opened and patient enrollment initiated in the AST-VAC2 clinical study.
Second Quarter 2017 and Recent Key Achievements

During the second quarter, the company continued to provide promising updates on recovery of arm, hand and finger function for patients that have been administered AST-OPC1:

Reported nine-month data from the AIS-A 10 million cell cohort that showed improvements in arm, hand, and finger function observed at three months and six months following administration of AST-OPC1 were confirmed and in some patients further increased at nine months. The results suggest a meaningful and favorable improvement to date in recovery of arm, hand, and finger function in patients treated with the 10 million cell dose of AST-OPC1 compared to the level of expected rates of spontaneous recovery based on historical control data of a closely matched patient population.
Reported new MRI data from the SCiStar study that indicates AST-OPC1 cells have durably engrafted in patients post-implantation, and have the potential to prevent lesion cavity formation, possibly reducing spinal cord tissue deterioration after spinal cord injury.
Lucas Lindner of Eden, Wisconsin, a former quadriplegic patient who has regained functional use of his fingers, hands, and lower arms after receiving 10 million cells of AST-OPC1 in the SCiStar study, threw out the ceremonial first pitch at a Major League Baseball game on August 13, 2017.
Management executed well to drive forward the AST-OPC1 program, particularly as it relates to enrollment, and will be providing additional data readouts for a growing number of patients in early 2018:

Completed enrollment and dosing in the AIS-B 10 million cell and AIS-A 20 million cell cohorts of the SCiStar study in July. The company has completed enrollment and dosing in four of the five planned cohorts in this study.
Enrollment and dosing of the fifth patient in the AIS-A 20 million cell cohort triggered the final $1.5 million grant payment from the California Institute for Regenerative Medicine (CIRM) under the existing $14.3 million Strategic Partnerships Award grant awarded to Asterias. Asterias expects to receive this grant payment in the third quarter of 2017.
Enrolled and dosed first patient in fifth and final cohort in the SCiStar study. Twenty-two patients have been administered AST-OPC1 in the SCiStar study and twenty-seven patients have been administered AST-OPC1 after including patients from a previous Phase 1 safety trial.
The FDA accepted the company’s amendment to the clinical research protocol for the SCiStar study. The amendment expands the eligibility criteria to include patients with a C-4 spinal cord injury and extends the dosing window to allow for administration of AST-OPC1 at up to 42 days post-injury.
Opened two additional clinical sites for the SCiStar study, providing additional geographical reach and previous experience with spinal cord injury trials. Asterias now has eight clinical sites throughout the country enrolling patients in the study.
Management is making progress related to its cancer immunotherapy programs as its AST-VAC2 program gets closer to entering the clinic:

Published positive AST-VAC1 Phase 2 clinical data in Acute Myeloid Leukemia in ‘Cancer,’ a leading peer-reviewed journal of the American Cancer Society.
Cancer Research UK, supported by Asterias technical personnel, successfully completed the manufacture of the first cGMP (current Good Manufacturing Practice) clinical grade lot of AST-VAC2, which met all release specifications. This lot will provide initial clinical trial material for patients enrolling in the upcoming Phase 1/2a study evaluating AST-VAC2 in non-small cell lung cancer.
Financial Results

Cash and cash equivalents as of June 30, 2017 were $11.9 million, while available-for-sale securities were $13.1 million. The combined total of cash, cash equivalents, and available-for-sale securities totaled $25.0 million.

Total revenues were $0.3 million for the second quarter. Revenues were comprised of grant income as well as royalty revenues on product sales by licensees. Research and development expenses were $7.0 million in the second quarter, with the primary driver being expenses associated with the company’s AST-OPC1 program. General and administrative expenses were $1.8 million in the second quarter.

Net loss was $8.7 million, or $0.18 per share, for the second quarter. For the quarter ended June 30, 2017, net cash used in operating activities was $7.0 million and net cash provided from financing activities was $0.9 million.