ImmunoCellular Therapeutics Provides Corporate Update and Reports Second Quarter 2018 Financial Results

On August 13, 2018 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE American: IMUC), a biotechnology company developing immunotherapies for the treatment of cancer based on its Stem-to-T-Cell research program, reported financial results for the second quarter ended June 30, 2018 (Press release, ImmunoCellular Therapeutics, AUG 13, 2018, View Source [SID1234529109]).

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Corporate Update

Stem-to-T-Cell Research Program: As previously disclosed, the Company through its research was able to verify a successful transfer of the selected T cell receptor genetic material into human hematopoietic stem cells. The Company is currently producing the transfected human hematopoietic stem cells that are intended for use in performing preclinical experiments. In this preclinical testing, the transfected human hematopoietic stem cells will be injected into animals and the maturation of the stem cells and integration into bone marrow will be monitored. The Company’s academic collaboration has progressed and a manuscript intended for publication in a scientific journal describing the results of that work is being prepared.

Strategic Alternatives Exploration: The Company has been actively engaged in a broad range of conversations with potential strategic partners to explore strategic alternatives, 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. These conversations have included the exchange of detailed information to determine the potential for an alignment of programs and strategies, as well as possible options for continuing to fund operation. The Company plans to continue this exploratory process with the assistance of its external strategic financial advisor, but cannot guarantee that any actions will be taken as a direct result of this review.

Clinical-Stage Programs: The ICT-107 (phase 3-ready for glioblastoma), ICT-121 (phase 1 completed for recurrent glioblastoma) and ICT-140 (phase 1/2-ready for ovarian cancer), are patient-specific dendritic cell-based immunotherapies targeting solid tumors. The Company continues to pursue opportunities for partnerships, licensing or sale of these anticancer assets.

Litigation Settlement: The Company reached a tentative, mutually acceptable agreement to settle the class action suit. The tentative agreement, which is subject to final documentation and Court approval, provides in part for a settlement payment of $1.15 million in exchange for mutual releases and the dismissal of all claims against the Company and its officers and directors in connection with the securities class action suit. The $1.15 million settlement payment will be fully funded by the Company’s insurance carrier.

Liquidity and Capital Resources: The Company has implemented an aggressive plan to reduce expenditures while remaining actively focused on operations and executing on key initiatives. As a result, the second quarter operating loss was reduced by 97%, or $11.0 million, to $307,090, compared to the second quarter of 2017. Working capital at the end of the second quarter was $3.4 million and the Company had cash of $2.9 million and no debt, as of June 30, 2018.

Anthony J. Gringeri, PhD, President and Chief Executive Officer commented: "During the second quarter and the first half of 2018, we continued to make significant progress on our strategies to advance our Stem-to-T-Cell program and explore strategic alternatives while also implementing actions to reduce our operating expenses to strengthen the financial condition of the company. Additionally, we are actively engaged with our strategic financial advisor to explore strategic opportunities for enhancing shareholder value. This remains a top priority for the ImmunoCellular management team and the board of directors."

Continued Dr. Gringeri: "We believe our Stem-to-T-Cell research program has the potential to be a game-changing treatment for cancer by utilizing the patient’s immune system to fight cancer. In April we were able to verify successful transfer of the selected T cell receptor genetic material into human hematopoietic stem cells. This milestone represents an important step in validating the Stem-to-T-Cell approach and is a key component of the proof-of-concept work for this technology which lays the groundwork for undertaking planning for preclinical testing. We are producing the transfected human hematopoietic stem cells that will be used for the preclinical phase of this program."

"We have streamlined our operations to manage our business in a fiscally responsible manner. Looking forward, we plan to remain focused on advancing our Stem-to-T-Cell research program, pursuing partnering, licensing or sale of our clinical-stage dendritic cell-based immunotherapy programs and enhancing shareholder value," concluded Dr. Gringeri.

Second Quarter 2018 Financial Results

For the quarter ended June 30, 2018, ImmunoCellular incurred a net loss of $306,704, or $(0.01) per basic and diluted share, compared to a net loss of $4.1 million or $(1.14) per basic and diluted share, for the quarter ended June 30, 2017. The decrease in the net loss is primarily due to the suspension of the ICT-107 phase 3 trial in June of 2017 and reductions in the Company’s other research and development programs along with reductions in general and administrative expenses.

Research and development expenses for the three months ended June 30, 2018 were $58,981 compared to $10,353,601 in the same period in 2017. During the quarter ended June 30, 2018, the Company’s trial related expenses were primarily limited to costs associated with its Stem-to-T-cell program. During the quarter ended June 30, 2017, the Company wrote off remaining supply inventories and expensed costs associated to wind down the phase 3 trial of ICT-107.

General and administrative expenses for the three months ended June 30, 2018 and 2017 were $670,203 and $988,266 respectively. This decrease was primarily due to reductions in compensation expense, professional fees, the number of members of the board of directors, board member compensation and the downsizing of corporate offices.

ImmunoCellular reported $3.8 million of cash used in operations during the six months period ended June 30, 2018, compared to $9.5 million in the same period in 2017. No warrants were exercised during 2018; accordingly, there were no financing proceeds. As of June 30, 2018, the Company had working capital of $3,427,092, compared to working capital of $4,647,903 as of December 31, 2017. The Company had no long-term debt obligations, no capital lease obligations, or other similar long-term liabilities, as of June 30, 2018, and the Company had approximately $2.9 million of cash and 41.9 million shares of common stock outstanding.

In light of ongoing research and exploratory strategic activities, ImmunoCellular is not holding a conference call to discuss second quarter 2018 financial results at this time. The Company plans to provide relevant updates at an appropriate time in the future.

Forty Seven Inc. Reports Second Quarter 2018 Financial Results and Recent Business Highlights

On August 13, 2018 Forty Seven Inc. (NASDAQ:FTSV), a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, reported financial results and provided a business update for the second quarter ended June 30, 2018 (Press release, Forty Seven, AUG 13, 2018, View Source [SID1234528979]).

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"The second quarter was a period of significant growth for Forty Seven, marked by our maturation into a publicly-traded company and the presentation of preliminary data from three clinical trials of 5F9, our leading monoclonal antibody against CD47," said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of Forty Seven, Inc. "Based on our early clinical experience with 5F9, we believe that harnessing macrophages in the fight against cancer may offer patients with difficult-to-treat solid and hematological tumors a new therapeutic option, with potential both as a single agent and in combination with approved tumor targeting antibodies and checkpoint inhibitors. We look forward to advancing our six ongoing studies of 5F9 toward multiple data readouts in 2019 and to broadening our investigative reach with the initiation of new trials, which we believe will allow us to fully explore 5F9’s potential across a range of tumor types and treatment modalities."

Second Quarter and Recent Business Highlights:

Pipeline:

In June 2018, Forty Seven presented preliminary data from three separate clinical trials evaluating 5F9 in patients with solid and hematological tumors. In these trials, 5F9 was safe and generally well-tolerated at all doses, with on-target anemia successfully mitigated by Forty Seven’s proprietary priming and maintenance dose regimen:

At the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois, Forty Seven presented proof-of-concept data from the first 22 patients in an ongoing Phase 1/2b trial evaluating 5F9 in combination with rituximab in patients with relapsed/refractory non-Hodgkin lymphoma (r/r NHL), including diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Forty Seven subsequently shared updated data from 30 patients in this trial, which showed an objective response rate of 47% and a complete response rate of 33%. Median duration of response was not reached with over six and eight months median follow-up in DLBCL and FL, respectively.

Also at ASCO (Free ASCO Whitepaper), Forty Seven presented data from a Phase 1 pharmacokinetic and pharmacodynamic trial of single-agent 5F9 in patients with advanced solid tumors. Data demonstrated preliminary evidence of anti-tumor activity, including two confirmed partial responses in patients with ovarian cancer.

At the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, Sweden, Forty Seven presented preliminary data from an ongoing Phase 1 clinical trial of monotherapy 5F9 in patients with relapsed/refractory acute myeloid leukemia. The data showed encouraging biologic activity, which supports continued evaluation of 5F9 in combination studies with azacitidine and atezolizumab.

O: 650-352-4150 F: 650-618-2308 W: fortyseveninc.com A: 1490 O’Brien Drive, Suite A, Menlo Park, CA 94025, United States

In June 2018, Forty Seven and its partner, Merck KGaA, dosed the first patient in a Phase 1b clinical trial evaluating 5F9 in combination with avelumab, Merck KGaA’s PD-L1 checkpoint inhibitor. The open-label, multicenter trial is designed to determine safety, tolerability and anti-tumor activity of the combination of 5F9 and avelumab in patients with ovarian cancer.

In May 2018, Forty Seven announced that the U.S. Food and Drug Administration granted two Fast Track designations to 5F9 for the treatment of r/r DLBCL and FL, two forms of B-cell NHL.

Corporate:

In July 2018, Forty Seven signed a settlement and license agreement with Synthon Biopharmaceuticals B.V., resolving the ongoing patent litigation and granting Forty Seven a sublicense that covers 5F9 for the treatment of cancer in combination with other antibodies. Under the terms of the agreement, Forty Seven will pay Synthon an aggregate of up to approximately $47 million, comprising an upfront payment upon grant of the sublicense and subsequent payments upon the achievement of future regulatory and commercial milestones, which comprise the significant majority of the aggregate payments. In addition, Forty Seven will pay Synthon an annual license fee and a royalty of a tiered, low single digit percentage on net sales of any approved licensed products.

In July 2018, Forty Seven closed its initial public offering of 8,090,250 shares of common stock at a price to the public of $16.00 per share, which includes the exercise in full by the underwriters of their option to purchase additional shares of common stock. The aggregate net proceeds to Forty Seven from the offering were $116.3 million.

In June 2018, Forty Seven entered into an asset purchase agreement with BliNK Biomedical SAS, through which the Company acquired all assets related to BliNK’s research and development program for antibodies directed against CD47. These assets consist of an anti-CD47 monoclonal antibody for potential use in non-oncology indications, in addition to certain patents and patent applications.

In April 2018, Forty Seven announced the appointment of Ian T. Clark to its board of directors.

In April 2018, Forty Seven announced the appointment of Ann D. Rhoads as chief financial officer.

Second Quarter 2018 Financial Results:

Cash Position: As of June 30, 2018, cash, cash equivalents and short-term investments were $58.0 million, as compared to $88.1 million as of December 31, 2017. Cash and cash equivalents as of June 30, 2018 do not include the proceeds from the Company’s initial public offering of common stock, which closed in July 2018. The Company expects that the proceeds from its initial public offering, together with its cash, cash equivalents and short-term investments as of June 30, 2018, will fund operating expenses and capital expenditure requirements into 2020.

R&D Expenses: R&D expenses were $13.6 million for the second quarter ended June 30, 2018, as compared to $9.2 million for the same period in 2017. This increase was primarily due to continued advancement of the Company’s current clinical programs and the expansion of the Company’s preclinical and discovery efforts, partially offset by the receipt of $1.4 million in grant funding recognized under the Company’s grants from the California Institute of Regenerative Medicine and the Leukemia & Lymphoma Society

G&A Expenses: G&A expenses were $3.4 million for the second quarter ended June 30, 2018, as compared to $1.7 million for the same period in 2017. This increase was primarily due to increased personnel costs and expenses incurred in preparation for the Company’s initial public offering.

Net Loss: Net loss was $16.7 million for the second quarter ended June 30, 2018, or $2.52 per basic and diluted share, as compared to a net loss of $10.8 million, or $1.68 per basic and diluted share, for the same period in 2017.

Checkpoint Therapeutics Announces Clinical Data on EGFR Inhibitor CK-101 Selected for Late-Breaking Oral Presentation at IASLC 19th World Conference on Lung Cancer

On August 13, 2018 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported that preliminary safety and efficacy data from a Phase 1/2 clinical trial of CK101 (also known as RX518), a third-generation epidermal growth factor receptor ("EGFR")
tyrosine kinase inhibitor ("TKI") being evaluated in advanced non-small cell lung cancer, has been selected for a late-breaking oral presentation at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer, to be held September 23-26, 2018, in Toronto (Press release, Checkpoint Therapeutics, AUG 13, 2018, View Source [SID1234528977]).

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"We are thrilled to announce that preliminary data from the Phase 1/2 trial of our novel thirdgeneration EGFR inhibitor has been selected for a late-breaking oral presentation at the World Conference on Lung Cancer. This marks the first clinical data to be reported by Checkpoint, an important clinical and corporate milestone," said James F. Oliviero, President and Chief Executive Officer of Checkpoint Therapeutics. "Third-generation EGFR inhibitors are highly selective and have the potential to demonstrate improved safety and tolerability versus earlier-generation
therapies. There is currently only one third-generation EGFR inhibitor approved and we believe CK-101 could be second to market potentially with a differentiated safety profile."
Details of the presentation are as follows:

Title: CK-101 (RX518), a Third Generation Mutant-Selective Inhibitor of EGFR in NSCLC: Results of an Ongoing Phase I/II Trial
Date: Monday, Sept. 24, 2018
Session: Novel Therapies in ROS1, HER2 and EGFR
Presenter: Melissa L. Johnson, M.D., Associate Director, Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, PLLC, Nashville, Tenn.
The full abstract will be posted on the conference website on Wednesday, Sept. 5, 2018, at 5 p.m. ET. For additional information, please visit: View Source Checkpoint holds an exclusive worldwide license (except with respect to certain Asian countries) to CK‐101, which it acquired from NeuPharma, Inc. in 2015.

About CK-101
CK-101 (also known as RX518) is an oral, third-generation, irreversible kinase inhibitor against selective mutations in the EGFR gene. Activating mutations in the tyrosine kinase domain of EGFR, such as L858R and exon 19 deletion, are found in approximately 20 percent of patients with advanced non-small cell lung cancer ("NSCLC").
Compared to chemotherapy, first-generation EGFR inhibitors significantly improved objective response rate and progression-free survival in previously untreated NSCLC patients carrying EGFR mutations. However, tumor progression could develop due to resistance mutations, often within months of treatment with first-generation EGFR inhibitors. The EGFR T790M "gatekeeper" mutation is the most common resistance mutation found in patients treated with first-generation EGFR inhibitors. The mutation decreases the affinity of first-generation inhibitors to EGFR kinase domain, rendering the drugs ineffective. Second-generation EGFR inhibitors have improved
potency against the T790M mutation, but have not provided meaningful benefits in NSCLC patients due to toxicity from also inhibiting wild-type EGFR. Third-generation EGFR inhibitors are designed to be highly selective against both EGFR-TKI-sensitizing and resistance mutations, with minimal activity on wild-type EGFR, thereby improving tolerability and safety profiles. Checkpoint Therapeutics is developing CK-101 for the treatment of NSCLC patients carrying the
susceptible EGFR mutations. These include the EGFR T790M mutation in second-line NSCLC patients, as well as the EGFR L858R and exon 19 deletion mutations in first-line NSCLC patients.

SBP Provides a Business Update and Files Report for Q2 2018

On August 13, 2018 Sun BioPharma, Inc. (OTCQB:SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases,reported financial results for the quarter ended June 30, 2018 (Press release, Sun BioPharma, AUG 13, 2018, View Source [SID1234528948]).

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Front-Line Combination PDA Study
The Company’s newest trial, a Phase 1a/1b combination of SBP-101 to be administered with gemcitabine and nab-paclitaxel in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (PDA), enrolled the first patients on June 13, 2018. Patients were enrolled at the Adelaide Cancer Centre in Adelaide, Australia under the direction of Associate Professor Dusan Kotasek and at the University of Florida Health Cancer Center in Gainesville,
Florida under the direction of Thomas J. George, MD, F.A.C.P. The Phase 1a portion of this study will treat up to 18 PDA patients in three cohorts in order to determine a recommended dose of SBP-101 to be given in combination with standard treatment. The Phase 1b portion will be an expansion at the recommended dose of SBP-101 and will guide SBP-101’s subsequent development for patients with PDA. This multi-center, front-line study has 3 sites in Australia, The Austin Health Cancer Trials Centre in Melbourne, The Adelaide Cancer Centre in Adelaide, The Blacktown Cancer and Haematology Centre in Sydney and one site in the United States, The University of Florida Health Cancer Center in Gainesville, Florida.

Suzanne Gagnon, MD, Chief Medical Officer for Sun BioPharma, Inc. commented, "The Company and our investigators are excited to have begun this first cohort of patients in the Phase 1a portion of this study. The clinics are enthusiastic about utilizing SBP-101 in front-line combination for previously untreated patients with metastatic PDA. We all will be closely monitoring these patients as they move through the protocol for this study."
Partial Close of Private Placement of Common Stock and Warrants During the quarter ended June 30, 2018 the Company entered into Securities Purchase Agreements (the "2018 Purchase Agreements") with accredited purchasers. The previously announced closing on May 16, 2018 totaled $1.0 million. Total common stock issued in this Private Placement was 216,000 shares with warrants to purchase up to an aggregate of 216,000
additional shares.

David B. Kaysen, President and CEO commented, "This private placement, managed by the Company, when completed, will provide the capital necessary to continue the first phase of our new combination trial for SBP-101. We anticipate early results from this first portion of the trial by early fourth quarter of 2018 depending on rate of patient enrollment. We are excited to take SBP-101 into the next stage of the clinical development process."
Financial Results for the Three and Six Months ending June 30, 2018

Operating Results
General and administrative ("G&A") expenses increased 34.3% to $654,000 in the second quarter of 2018 up from $487,000 in the second quarter of 2017. G&A decreased 24.5% to 1.3 million in the six months ended June 30, 2018, down from $1.7 million in the six months ended June 30, 2017. The increase in the second quarter is due primarily to an increase in stock compensation expense. The decrease in the six months ended June 30, 2018 is due primarily to lower salary expense associated with the waiver of contingent payments which occurred in February of 2018.
Our research and development ("R&D") expenses decreased 34.5% to $442,000 in the second
quarter of 2018 down from $675,000 in the second quarter of 2017. R&D decreased 27.8% to 1.0
million in the six months ended June 30, 2018, down from $1.4 million in the six months ended
June 30, 2017. The decrease for both the quarter and the six months ended June 30, 2018 was
due primarily to decreased salary expense associated with fewer employees and modest
spending on the Company’s new clinical study which just began dosing patients in the current
quarter.

Other net expense was $1.5 million and $364,000 for the three months ended June 30, 2018 and 2017, respectively. Other expense in the current quarter was primarily interest expense on the Company’s convertible notes payable, including the write-off of the outstanding debt discount on May 16, 2018 when the notes were converted to common stock and warrants per the original terms of the notes. Other expense in the quarter ended June 30, 2017 was prima Balance Sheet and Cash Flow

Total cash was $0.9 million as of June 30, 2018, compared to $152,000 as of December 31, 2017. Total current assets were $1.5 million and $767,000 as of June 30, 2018, and December 31, 2017, respectively. Thisincrease in cash is the result of our sale of equity securities in the 2018 Purchase Agreements totaling $2.3 million for the six months ended June 30, 2018 partially offset by the use of cash to fund operations. Current liabilities decreased to $1.4 million as of June 30, 2018, compared to $4.2 million as of December 31, 2017. The decrease in current liabilities resulted primarily from the conversion of the Company’s convertible notes payable, totaling approximately $3.3 million in principal and accrued interest, for common stock and warrants and from the waiver of contingent payment obligations of $1.1 million.

Net cash used in operating activities was $1.6 million in the six-months ended June 30, 2018, compared to $2.4 million in the same period of the prior year. The net cash used in each of these periods primarily reflects the net loss for these periods and was partially offset by the effects of changes in operating assets and liabilities. In the six months ended June 30, 2017, the net loss is also offset by non-cash charges recorded for the loss on induced debt conversion and sharebased compensation.

About SBP-101
SBP-101 is a first-in-class, proprietary, polyamine compound designed to exert therapeutic effects in a mechanism specific to the pancreas. Sun BioPharma originally licensed SBP-101 from the University of Florida Research Foundation in 2011. The molecule has been shown to be highly effective in preclinical studies of human pancreatic cancer models, demonstrating superior activity to existing FDA-approved chemotherapy agents. Combination therapy potential has also been shown for pancreatic cancer. SBP-101 is expected to differ from current pancreatic cancer
therapies in that it specifically targets the exocrine pancreas and has shown efficacy against primary and metastatic disease in animal models of human pancreatic cancer. Therefore management believes that SBP-101 may effectively treat both primary and metastatic pancreatic cancer, while leaving the insulin-producing islet cells and non-pancreatic tissue unharmed. The safety and metabolic profile demonstrated in our first-in-human safety study further supports
evaluation of the potential for additive or synergistic effects in combination with current standard pancreatic cancer treatment.

Unum Therapeutics Reports Second Quarter 2018 Financial Results and Provides Business Update

On August 13, 2018 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies based on its novel, universal Antibody-Coupled T cell Receptor (ACTR) technology platform, reported financial results and provided a corporate update for the second quarter ended June 30, 2018 and recent activities (Press release, Unum Therapeutics, AUG 13, 2018, View Source [SID1234528937]).

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"In our first full quarter as a public company, we made significant progress in developing our proprietary, universal ACTR technology platform and advancing our pipeline of cellular immunotherapies through clinical development," said Chuck Wilson, CEO of Unum. "We continue to evaluate ACTR T cell potential in combination with different tumor-targeting antibodies in three ongoing multicenter Phase I trials. We expect to report preliminary data from these trials late this year. In addition, we are particularly pleased to announce that our investigational new drug (IND) application for ACTR T cells in combination with trastuzumab for the treatment of patients with HER2+ advanced cancers is now active and we are preparing to initiate a multi-center Phase I trial, ATTCK-34-01, by the end of 2018. This represents our first solid tumor product candidate based on our universal ACTR technology."

Recent Highlights

Cohort Expansion Phase of ATTCK-20-2 Phase I trial is Underway: During the quarter, Unum initiated the cohort expansion phase of the ATTCK-20-2 trial evaluating safety and anti-lymphoma activity of ACTR087 at the preliminary recommended phase 2 dose level used in combination with rituximab in patients with CD20+ relapsed or refractory (r/r) NHL. Unum expects to have updated data, including preliminary data from the cohort expansion part of the ATTCK-20-2 trial, by the end of 2018 and to report these at that time or in early 2019.

In addition, Unum has now filed a protocol amendment to the ATTCK-20-2 trial to explore ACTR087 in combination with an alternative rituximab dosing regimen from what has been studied to date. Preclinical studies have shown that the level of ACTR T cell activity depends upon the amount of the co-administered antibody. As such, ACTR087 safety and anti-tumor activity in combination with rituximab in CD20+ r/r NHL may be even further optimized by an alternative rituximab regimen. Testing of the alternative regimen will be incorporated into the expansion cohort of the study, which is already underway.
Continued Patient Enrollment and Dosing in ATTCK-20-03 Phase I trial: Unum continued to enroll and dose patients in ATTCK-20-03, a Phase I, multi-center, open-label clinical trial evaluating the safety, tolerability, and anti-lymphoma activity of ACTR707 used in combination with rituximab in patients with CD20+ r/r NHL. The Company expects to report preliminary data from the trial in the fourth quarter of 2018.

Continued Patient Enrollment and Dosing in ATTCK-17-01 Phase I trial: Unum continued to enroll and dose patients in ATTCK-17-01, a Phase I, multi-center, open-label clinical trial designed to test the safety, tolerability, and anti-myeloma activity of ACTR087 used in combination with SEA-BCMA in patients with r/r multiple myeloma. This is the first clinical trial under our collaboration with Seattle Genetics. Unum expects to report preliminary data from this study in the fourth quarter of 2018.

Active IND for First Solid Tumor ACTR Product Candidate:Unum announced that the IND for ACTR T cells used in combination with trastuzumab for the treatment of patients with HER2+ advanced cancers is now active and the Company expects to initiate clinical development for this product candidate by end of 2018.

Presented Pre-Clinical Data on ACTR Platform at American Society of Hematology (ASH) (Free ASH Whitepaper) Summit (ASH) (Free ASH Whitepaper) On Emerging Immunotherapies for Hematological Diseases: In July, Unum presented pre-clinical data on its proprietary ACTR T cells used in combination with daratumumab, a CD38-specific antibody. The Company is particularly interested in the potential benefit that CD38-targeted ACTR T cells can provide for patients with hematological malignancies, including acute myeloid leukemia and multiple myeloma. These data support Unum’s development of ACTR T cells in patients with these diseases, and against a highly-validated tumor target for which other T cell therapies have seen significant challenges.
Second Quarter 2018 Financial Results

Collaboration Revenue: Collaboration revenue recognized during the second quarter ended June 30, 2018 and 2017, of $1.7 million and $2.1 million, respectively, reflects the recognition of a portion of the $25.0 million upfront payment received from Seattle Genetics under Unum’s collaboration agreement as well as reimbursements of research and development costs by Seattle Genetics. Effective January 1, 2018, Unum adopted the new revenue recognition standard, ASC 606, which changed the manner in which the Company recognizes revenue from this collaboration agreement compared to the prior year period.

R&D Expenses: Research and development expenses were $9.1 million for the second quarter ended June 30, 2018, compared to $7.1 million for the same period last year. The increase reflects higher clinical trial costs for the active Phase I clinical trials, as well as increased personnel-related costs, materials and facility-related costs related to scaling manufacturing processes, and increased consultant costs. This was partially offset primarily by a decrease in consulting and manufacturing costs incurred for the Phase I clinical trial of ACTR087 in combination with rituximab as there was no production activity in the second quarter of 2018.

G&A Expenses: General and administrative expenses for the second quarter ended June 30, 2018, were $2.0 million, compared to $1.0 million for the same period last year. The increase is primarily due to expenses around operating as a public company and higher personnel related costs.

Net Loss: Net loss attributable to common stockholders was $9.0 million, or $0.31 per share, for the second quarter ended June 30, 2018, and $5.9 million, or $0.58 per share, for the same period last year.

Cash, Cash Equivalents and Marketable Securities: As of June 30, 2018, Unum had cash, cash equivalents, and marketable securities of $94.4 million, which includes approximately $63.9 million in net proceeds from the IPO and $5.0 million from the concurrent private placement. The Company believes that its existing cash, cash equivalents, and marketable securities, will fund operating expenses and capital expenditure requirements through at least December 2019, without considering $15.0 million in available borrowings under its loan and security agreement.