On August 13, 2018 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), reported financial results for the fiscal 2018 third quarter ended June 30, 2018 (Press release, Applied DNA Sciences, AUG 13, 2018, View Source [SID1234529276]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Commenting on Applied DNA’s results for the fiscal third quarter, Dr. James A. Hayward, president and CEO, stated, "Results for the quarter did not fulfill our expectations for recognized revenue due to the shipping of an initial cotton DNA order under extended payment terms. Nonetheless, our performance stands out for the progress we have made in driving commercial adoption of our DNA taggant platform through large commercial-scale feasibility activities:

·in pharmaceuticals, together with Colorcon we performed a larger scale production run for solid oral dosage form tagging;
·in leather, we are nearing the completion of a commercial-scale tagging and testing trial following the completion of the feasibility program supported by several global brands and supply chain stakeholders,
·and in cannabis, we designed, built and publicly unveiled our cannabis tracking system (CTS), a major milestone under our TheraCann agreement which will power seed-to-sale legal cannabis tracking.

In addition to these activities under existing development contracts, we signed new agreements with large marquee companies, UL and Everledger, that we expect will broaden our access to new markets and increase our value proposition to customers. Concurrently, business in our biopharma research and manufacturing offerings has been gaining promising momentum."

Continued, Dr. Hayward, "As global supply chains move to address growing business imperatives centered on supply chain traceability, transparency and trust, we are expanding our opportunities for revenue by seeding markets with partners that recognize the value proposition of our taggant technology. With momentum growing globally for the legalization of cannabis and supply chain participants seeking regulatory compliance, our launch of the industry’s first seed-to-sale cannabis tagging system with TheraCann is timely. Our partner Everledger, endorses our view that the linkage of digital blockchain-enabled transactions with a forensic physical goods identifier increases the value of the platform to global ecosystems. That identifier is our DNA taggant.

"We also reached new milestones in biotherapeutic contract research and contract manufacturing of linear DNA, with multiple firms throughout Europe and the US. We believe that our ability to deliver large-scale PCR-based DNA production for DNA/RNA vaccines, gene therapies, adoptive cell therapies and diagnostics, may eliminate the risks associated with current plasmid- and virus-based genetic methods. With these milestones, we demonstrate the potential to replace plasmid production methods and viral vectors, potentially opening large, high-value markets that will bring the benefits of our technology to patients.

Concluded Hayward, "Applied DNA sits at the nexus between global supply chains and market forces dictating the need for increased transparency and responsible procurement. With our taggant technology platform proven at scale, a foundation of recurring revenues, new commercial agreements that open previously untapped markets, we are well positioned to leverage tailwinds in the marketplace to deliver sustainable growth to our shareholders."

Fiscal Third Quarter Financial Results:

·Revenues decreased 43% for the third quarter of fiscal 2018 to $1.0 million, compared with $1.8 million reported in the third quarter of fiscal 2017, and remained flat as compared to revenues for the fiscal second quarter ended March 31, 2018. The year-over-year decrease in revenues is primarily attributable to shipments relating to the initial order of $1.2 million in our cotton vertical for the upcoming ginning season being recorded in deferred revenue at June 30, 2018 due to extended payment terms. This decrease was offset by an increase in revenues from feasibility pilots in pharmaceutical and cannabis industries.
·Deferred revenue increased to $2.3 million as of June 30, 2018 as compared to $352 thousand at September 30, 2017. The reason for this increase is due to the initial cotton order of $1.2 million noted above as well as fees paid for a variety of contracts that include specific milestones and therefore were not able to be fully recognized as revenue during the quarter ended June 30, 2018.
·Total operating expenses were $3.6 million, compared with $4.2 million in the prior year’s quarter, a decrease of approximately 13%. The decrease in year-over-year total operating expenses is primarily attributable to a decrease in stock-based compensation expense of $328 thousand and bad debt expense of $343 thousand.
·Net loss for the quarter ended June 30, 2017 was $2.9 million, or $0.10 per share, compared with a net loss of $2.6 million, or $0.10 per share for the same period in the prior fiscal year and a net loss of $2.1 million, or $0.07 per share for the first fiscal quarter ended March 31, 2018.
·Excluding non-cash expenses, Adjusted EBITDA for the quarter ended June 30, 2018 was negative $2.5 million, compared to negative Adjusted EBITDA of $1.5 million for the same quarter last fiscal year and negative Adjusted EBITDA of $2.3 million in the prior fiscal quarter. See below for information regarding non-GAAP measures.

Nine-Month Financial Highlights:

·Revenues for the first nine months of fiscal 2018 totaled $2.7 million, a decrease of 25% from $3.6 million from the same period in the prior fiscal year. The decrease in revenues was due to the deferral of approximately $1.2 million for product shipped for the marking of cotton with extended payment terms during the quarter ended June 30, 2018.
·Operating expenses for the nine months ended June 30, 2018 decreased by $2.8 million or 22% for the same period last fiscal year. The decrease is primarily attributable to a decrease in stock-based compensation, offset by an increase in R&D due to the government contract award.
·Net loss for the nine months ended June 30, 2018 was $8.2 million or $0.28 per share, compared with a net loss of $10 million or $0.38 per share for the nine months ended June 30, 2017.
·Excluding non-cash expenses and interest, Adjusted EBITDA for the nine months ended June 30, 2018 was a negative $7.6 million as compared to a negative $6.6 million for the same period in the prior fiscal year. See below for information regarding non-GAAP measures.

Recent Operational Highlights:

·On August 2, Applied DNA announced that it has reached new milestones in therapeutic contract research and contract manufacturing of Polymerase Chain Reaction (PCR)-produced linear DNA. PCR is a well-proven technique of DNA amplification that holds the potential to replace plasmid production methods and viral vectors in nucleic acid based therapeutics.

·On July 31, the Company announced the signing of a MOU with Everledger to build a CertainT Blockchain platform for high-end product markets. The molecular tag, test and track platform provides physical identity and traceability for Everledger’s digital platform with the leather supply chain as the first target market.

·On July 24, the Company announced that, in conjunction with TheraCann International, it will launch the cannabis industry’s first DNA based cannabis tagging system (CTS) using Applied DNA’s CertainT platform of tag, test and track. The device is designed to rapidly molecularly tag cannabis plants in commercial harvests of any scale.

·On July 17, Applied DNA announced the shipment of a $1.2 million order in its fiscal 2018 third quarter to tag cotton in the upcoming 2018/2019 ginning season. The order for the Company’s SigNature T platform technology will be used to tag, test and track three US cotton varietals, Pima, Acala and Delta. Revenues were deferred until payment is due.

·On July 10, the Company announced a strategic partnership with UL. The commercial agreement aims to expand product authentication and traceability solutions throughout the product supply chain.

·On May 8, Applied DNA announced that Louis Dreyfus Company (LDC) has installed Applied DNA Sciences’ SigNature T cotton traceability system at its Moree gin in Australia to tag, test and track pure HomeGrown Australian cotton.

Fiscal Third Quarter 2018 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal third quarter-end 2018 results on Monday, August 13, 2018 at 4:30 PM ET. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, due to the large number of expected participants, not all questions may be answered.

To Participate:

·Participant Toll Free: 1-844-887-9402
·Participant Toll: 1-412-317-6798
·Please ask to be joined to the Applied DNA Sciences call

Live webcast: View Source

Replay (available 1 hour following the conclusion of the live call through August 14, 2018):

·Participant Toll Free: 1-877-344-7529
·Participant Toll: 1-412-317-0088
·Participant Passcode: 10122259
·Webcast replay: View Source

Information about Non-GAAP Financial Measures

As used herein, "GAAP" refers to accounting principles generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a numerical measure of a company’s historical or future performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial measure for internal financial and operational decision making purposes and as a means to evaluate period-to-period comparisons of the performance and results of operations of our core business. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our business by excluding non-cash expenses that may not be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making.

"EBITDA"- is defined as earnings (loss) before interest expense, income tax expense and depreciation and amortization expense.

"Adjusted EBITDA"- is defined as EBITDA adjusted to exclude (i) stock-based compensation and (ii) other non-cash expenses.

On August 13, 2018 Sutro Biopharma, Inc.,and TheLeukemia & Lymphoma Society , or LLS, reported that they are partnering to develop STRO-001, Sutro’s CD74-targeting antibody-drug conjugate, to treat relapsed and/or refractory multiple myeloma and non-Hodgkin’s lymphoma (Press release, Sutro Biopharma, AUG 13, 2018, View Source [SID1234529232]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CD74 is a protein highly expressed in B-cell malignancies such as myeloma and lymphoma.

LLS has agreed to contribute clinical development funding for STRO-001 — Sutro’s first internally-developed product candidate — through its Therapy Acceleration Program, which forges collaborations with biotechnology companies to help bring innovative therapies to patients faster.

Sutro intends to use the funding for a Phase 1 study, initiated in April of this year, to evaluate STRO-001 for treating multiple myeloma, diffuse large B-cell lymphoma, mantle cell lymphoma andindolent lymphomas, such asfollicular lymphoma.

The clinical trial is currently open and enrolling patients at City of Hope Comprehensive Cancer Center, Duarte, CA; Medical College of Wisconsin, Milwaukee; Texas Oncology, Austin; Rocky Mountain Cancer Centers, Aurora, CO; and Virginia Cancer Specialists in Fairfax. Sutro plans to add more sites later this year.

The study’s primary outcome measures are safety and tolerability of STRO-001 in dose escalation, and preliminary anti-tumor activity in dose expansion. This is the first clinical trial on a product candidate created with cell-free protein synthesis.

Sutro is obligated to make payments to The Leukemia & Lymphoma Society based on pre-specified late-stage clinical development, regulatory and commercialization milestones.

Financial terms of the partnership have not been disclosed.

"LLS is committed to advancing therapies to address critical unmet need," said Lee Greenberger, Ph.D., LLS chief scientific officer. "New options for therapies are vital for patients with non-Hodgkin’s lymphoma and myeloma who do not respond to available treatments. Sutro’s approach offers a promising option for these patients."

Sutro CEO Bill Newell said: "Despite treatment advances, many multiple myeloma and non-Hodgkin’s lymphoma patients have treatment-resistant disease or continue to suffer relapses, and their physicians have limited options, underscoring the need fornovel targeted therapies.

"Our collaboration with The Leukemia & Lymphoma Society will facilitate expansion of clinical research on STRO-001 for patients with progressive disease following standard of care therapies."

Added Dr. Arturo Molina, a medical oncologist and Sutro’s chief medical officer: "It’s difficult to find well-tolerated treatments that effectively target tumors in relapsed and refractory lymphoma and multiple myeloma. This partnership will enable us to examine if STRO-001 can be a potent new option for targeting these tumors."

Preclinical research findings presented by Sutro at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s 2017 annual meeting and at other scientific meetings last year highlighted the specificity of STRO-001’s anti-CD74 antibody component, the high prevalence of CD74 expression in myeloma and lymphoma tumor samples, STRO-001’s potent in vitrocytotoxicity in multiple B-cell tumor cell lines and its anti-tumor activity in multiple myeloma and lymphoma xenograft models.

Sutro’s Proprietary Cell-Free Platform

STRO-001 was developed with Sutro’s XpressCFTMand XpressCF+TM proprietary cell-free protein synthesis and site-specific conjugation platforms, which enable rapid evaluation of a wide variety of protein structures and design and manufacturing of a highly-optimized single molecular species, rather than the usual mixture of imprecisely conjugated antibodies that comprise an antibody drug conjugate made by conventional cell-based manufacturing.

This cell-free technology should allow Sutro to move optimized proteins seamlessly through every stage of development — from discovery through commercial-stage production, without needing to generate individual cell lines for protein production.

Sutro’s manufacturing center in San Carlos, California, is built to maximize the speed and efficiency of protein production and is the first and only current cGMP-compliant, scalable cell-free manufacturing facility.

Added Dr. Trevor Hallam, Sutro’s chief scientific officer: "With XpressCF+TM, we incorporate non-natural amino acids into specific positions on the generated antibody for site-specific conjugation of cytotoxins with a linker and warhead to enable consistent, stable, pinpoint placement of STRO-001’s toxic payload. This leads to highly efficient delivery of the cytotoxin to tumor cells. By contrast, earlier generations of ADCs can have unpredictable pharmacologic properties, resulting in the potential for sub-optimal stability, compromised efficacy and poor tolerability for patients."

On August 13, 2018 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN) ("Diffusion" or "the Company"), a clinical-stage biotechnology company focused on improving patient outcomes in unmet medical needs using its novel small molecule trans sodium crocetinate (TSC), reported its financial results for the three months ended June 30, 2018 and provides a business update (Press release, Diffusion Pharmaceuticals, AUG 13, 2018, View Source [SID1234529170]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Commenting on the second quarter, David Kalergis, Chairman and Chief Executive Officer, said, "We have continued to screen and enroll patients with inoperable glioblastoma multiforme (GBM) into our INTACT Phase 3 pivotal trial. Following the dose escalation run-in portion, this planned 236-patient study will enroll half the patients in the treatment arm consisting of standard-of-care radiation and chemotherapy plus TSC, and half in the control arm, which is standard-of-care alone. We designed INTACT based on our Phase 2 study that demonstrated a nearly four-fold increase in overall survival at two years in inoperable GBM patients."

Mr. Kalergis continued, "During the quarter, U.S. Patent 9,950,067 issued relating to methods of treating cancer using bipolar trans carotenoids including TSC. European patent 2575487 was validated for oral formulations of bipolar trans carotenoids and includes novel compositions in tablet, pill or capsule form. Further, US Patent 10,016,384, also relating to oral formulations of bipolar trans carotenoids, issued on July 10, 2018. We believe TSC holds great promise in treating a number of diseases in addition to cancer and are pleased to be able to protect a patient-friendly oral formulation suitable for more chronic uses. Our intellectual property protection further supports the value of TSC as we discuss partnership opportunities in various indications and geographies."

Diffusion is continuing preparations for a Phase 2 randomized, double-blind, placebo-controlled trial with TSC in acute stroke in cooperation with UCLA and the University of Virginia, and is in discussions with potential partners. Financing permitting, we expect to begin enrolling patients in early 2019 with data in about 18 months thereafter. The study calls for the administration of TSC by specially-trained Emergency Medical Technicians to ambulance-transported patients within two hours of the onset of a suspected acute stroke. In-ambulance administration could overcome the current severe timing delay in administering therapy to stroke victims, serving a market of up to 800,000 patients a year who suffer acute stroke.

Financial Results for the Three Months Ended June 30, 2018

We had cash and cash equivalents of $12.9 million as of June 30, 2018. We believe that our cash and cash equivalents will enable us to fund our obligated operating expenses and capital expenditure requirements into September 2019.

We recognized $1.4 million in research and development expenses during the three months ended June 30, 2018, compared with $1.2 million during the three months ended June 30, 2017. The increase was mainly attributable to a $0.8 million increase in expenses related to our Phase 3 GBM trial, offset by a $0.6 million decrease in expense associated with manufacturing costs.

General and administrative expenses for the three months ended June 30, 2018 were $1.7 million, compared with $1.8 million for the three months ended June 30, 2017. The decrease in general and administrative expense was primarily due to a $0.3 million decrease in professional fees, partially offset by an increase in salary and wages expense of $0.2 million.

Net cash used in operating activities for the first half of 2018 was $5.8 million, compared with $6.2 million during the same period in the prior year.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.