On May 10, 2018 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 first quarter ended March 31, 2018 (Press release, Fate Therapeutics, MAY 10, 2018, View Source [SID1234526478]).

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"We have generated a strong package of preclinical safety, efficacy and manufacturing data for FT500, and expect to submit an IND application for this first-of-kind NK cell product in the second quarter of 2018. We look forward to continuing our productive interactions with the FDA to pioneer the use of clonal master iPSC lines for the renewable production and clinical use of universal, off-the-shelf cellular immunotherapies for cancer," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "In addition, we are encouraged by the initial clinical data emerging from our two donor-derived cell therapy programs. We have observed safety, persistence and anti-tumor activity with NK100 in initial Phase 1 dose escalation against solid and liquid tumors. Additionally, no events of cancer relapse have been reported in our Phase 1 PROTECT study of ProTmune, and new immune reconstitution data from these subjects support the potential of ProTmune to fight against infections and residual disease."

Clinical Programs – Highlights & Updates

Reported New ProTmune Clinical Data Showing No Events of Cancer Relapse. In March, the Company presented additional Phase 1 PROTECT data from seven subjects administered ProTmune, the Company’s next-generation hematopoietic cell graft for patients with hematologic malignancies. As of a February 26, 2018 data cut-off, with a median time on study of 228 days, no serious adverse events related to ProTmune and no events of cancer relapse had been reported by investigators. The Company also presented immune reconstitution data, which indicate that the T- and NK cell compartments of ProTmune are functional and capable of fighting against infections and cancer. The randomized, controlled and double-blinded Phase 2 PROTECT study is currently open for enrollment at 15 U.S. centers.
Advancing FATE-NK100 in Multiple Phase 1 Studies. In February, the first subject was administered NK100, the Company’s first-in-class, donor-derived adaptive memory natural killer (NK) cell cancer immunotherapy, in the DIMENSION study. This ongoing Phase 1 clinical trial is assessing the safety and efficacy of NK100 when administered as a monotherapy and in combination with trastuzumab or cetuximab, two FDA-approved monoclonal antibodies that are widely used today to treat various solid tumor malignancies. Additionally, initial clinical data from the first two subjects administered NK100 in the ongoing Phase 1 APOLLO study for recurrent ovarian cancer were presented at the Innate Killer Summit in March and showed no dose-limiting toxicities. The Day 28 response evaluation for Subject 2 showed stable disease with evidence of tumor reduction.
Universal Off-the-Shelf Cancer Immunotherapy Preclinical Programs – Highlights & Updates

Completed Key Activities to Support FT500 IND Submission. The Company remains on track to submit in the second quarter of 2018 an Investigational New Drug (IND) application for FT500, a universal, off-the-shelf NK cell product manufactured from a clonal master induced pluripotent stem cell (iPSC) line. A preclinical in vivo GLP toxicity and tumorigenicity study in animals demonstrated that FT500 was well tolerated. There were no mortality events in any FT500-treated cohorts and no adverse clinical observations related to FT500. Additionally, FT500 produced from multiple clinical-scale manufacturing runs met pre-established specifications for identity, purity and potency as set forth in the Company’s pre-IND meeting with the FDA. The Company plans to clinically investigate FT500 in combination with FDA-approved checkpoint inhibitors as a rescue therapy.
Secured $4M from CIRM to Advance FT516 into a First-in-Human Clinical Trial. The award from the California Institute for Regenerative Medicine (CIRM) is being used to support ongoing IND-enabling activities. FT516 is a universal, off-the-shelf NK cell product manufactured from a clonal master iPSC line engineered to uniformly express a high-affinity, non-cleavable CD16 Fc receptor. Since CD16 is able to bind the Fc region of tumor-targeted antibodies, FT516 can be combined with FDA-approved monoclonal antibody therapies to target a broad spectrum of tumor-associated antigens. The Company has shown in preclinical studies that FT516 exhibits potent and persistent anti-tumor activity in vitro and in vivo against multiple tumor types, including in combination with monoclonal antibody therapies that target CD20, HER2 and EGFR.
Presented Dual-targeted Anti-tumor Activity of FT819 for Antigen Escape. The Company presented breakthrough preclinical data demonstrating the dual-targeted anti-tumor activity of FT819, a universal, off-the-shelf CAR19 T-cell product, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April. FT819 exhibited a target-specific T-cell response in vitro when challenged with CD19-positive tumor cells and displayed robust production of effector cytokines and cytolytic proteins. In addition, FT819 elicited antibody-dependent cell-mediated cytotoxicity in vitro against CD19-negative, CD20-positive tumor cells when combined with rituximab, a monoclonal antibody targeting CD20. The Company is developing FT819, which is derived from a clonal master iPSC line engineered to completely eliminate the T-cell receptor, insert a chimeric antigen receptor (CAR) targeting CD19 into the T-cell receptor (TRAC) locus and express CD16 to mitigate antigen escape, under its exclusive iPSC-derived T-cell collaboration with Memorial Sloan Kettering Cancer Center led by Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering.
First Quarter 2018 Financial Results

Cash & Short-term Investment Position: Cash, cash equivalents and short-term investments as of March 31, 2018 were $88.6 million compared to $100.9 million as of December 31, 2017. The decrease was primarily driven by the Company’s use of cash to fund operating activities.
Total Revenue: Revenue was $1.0 million for the first quarter of 2018 as well as for the same period in 2017. All revenue was derived from the Company’s research collaboration and license agreement with Juno Therapeutics.
R&D Expenses: Research and development expenses were $11.5 million for the first quarter of 2018, compared to $8.0 million for the same period in 2017. The increase in R&D expenses was primarily attributable to an increase in third-party service provider fees related to the clinical development and manufacture of ProTmune and FATE-NK100 and to IND-enabling activities for FT500, as well as an increase in equipment and materials associated with the preclinical development of the Company’s iPSC-derived cancer immunotherapy programs and in employee compensation associated with growth in headcount.
G&A Expenses: General and administrative expenses were $3.6 million for the first quarter of 2018, compared to $3.0 million for the same period in 2017. The increase in G&A expenses was primarily attributable to an increase in stock-based compensation expense and in intellectual property costs.
Shares Outstanding: Common shares outstanding were 52.9 million as of March 31, 2018 and 52.6 million as of December 31, 2017. Preferred shares outstanding as of March 31, 2018 and December 31, 2017 were 2.8 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.
Today’s Conference Call and Webcast

The Company will conduct a conference call today, Thursday, May 10th, 2018 at 5:00 p.m. ET to review financial and operating results for the quarter ended March 31, 2018. In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 5592629. The live webcast can be accessed under "Events & Presentations" in the Investors & Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

About FATE-NK100

FATE-NK100 is an investigational, first-in-class, allogeneic donor-derived natural killer (NK) cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of activated NK cells expressing the maturation marker CD57. Higher frequencies of CD57+ NK cells in the peripheral blood or tumor microenvironment in cancer patients have been linked to better clinical outcomes. In August 2017, non-clinical data describing the unique properties and anti-tumor activity of FATE-NK100 were published by Cancer Research (doi:10.1158/0008-5472.CAN-17-0799), a peer-reviewed journal of the American Association of Cancer Research. Three clinical trials of FATE-NK100 are currently being conducted: VOYAGE for the treatment of refractory or relapsed acute myelogenous leukemia; APOLLO for the treatment of recurrent ovarian cancer; and DIMENSION for the treatment of advanced solid tumors, including in combination with monoclonal antibody therapy.

About ProTmune

ProTmune is an investigational next-generation hematopoietic cell graft for the prevention of acute graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT). ProTmune is manufactured by pharmacologically modulating a donor-sourced, mobilized peripheral blood graft ex vivo with two small molecules (FT1050 and FT4145) to decrease the incidence and severity of acute GvHD while maintaining the anti-leukemia activity of the graft. ProTmune has been granted Orphan Drug and Fast Track Designations by the U.S. Food and Drug Administration, and Orphan Medicinal Product Designation by the European Commission. ProTmune is currently being investigated in a randomized, controlled and double-blinded Phase 2 clinical trial in adult subjects with hematologic malignancies undergoing matched unrelated donor HCT.

About Fate Therapeutics’ iPSC Product Platform

The Company’s proprietary iPSC product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event, and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for consistently and repeatedly manufacturing homogeneous cell products in quantities that support the treatment of many thousands of patients in an off-the-shelf manner. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 90 issued patents and 100 pending patent applications

On May 10, 2018 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, reported financial results for the first quarter ended March 31, 2018 and provided a pipeline update (Press release, Regulus, MAY 10, 2018, View Source [SID1234526494]).

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"We are very pleased with the progress being made on advancing our pipeline, including the recent initiation of the multiple ascending dose (MAD) study for RGLS4326; the advancement of two new pre-clinical programs in important areas of unmet need; and the continued advancement of the RG-012 program," said Jay Hagan, President and Chief Executive Officer of Regulus. "These two new pre-clinical programs represent attractive areas of development for Regulus beyond our two chronic kidney disease programs."

Pipeline Update

RGLS4326 for autosomal dominant polycystic kidney disease (ADPKD): As previously announced, a Phase 1 MAD study was recently initiated in healthy volunteers. This trial was initiated based on data from the ongoing Phase 1 single ascending dose (SAD) trial, in which RGLS4326 has been determined to be well tolerated to date. The Phase 1 SAD study has completed dose escalation and continues in the planned follow-up phase, which is on-track for completion in the second half of 2018. Data from both studies will provide pharmacokinetics and safety data in advance of the Phase 2 proof-of-concept (POC) study estimated for initiation in the second half of 2019.

Pre-clinical programs: Based on robust human in vitro data and murine in vivo data, the Company announced today it is advancing programs in Hepatitis B virus and immunology (targets undisclosed).

RG-012 for Alport syndrome: The Phase 2 HERA study is ongoing and data from the Phase 1 renal biopsy study is anticipated by year-end 2018.

Financial Results

Cash Position: As of March 31, 2018, Regulus had cash, cash equivalents and short-term investments of $45.1 million.

Research and Development (R&D) Expenses: R&D expenses were $11.8 million for the quarter ended March 31, 2018, compared to $15.8 million for the quarter ended March 31, 2017. The decrease was primarily the result of a reduction in personnel-related costs subsequent to our May 2017 corporate restructuring and the wind-down of clinical activities related to the RG-101 program.

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General and Administrative (G&A) Expenses: G&A expenses were $3.8 million for the quarter ended March 31, 2018, compared to $4.0 million for the quarter ended March 31, 2017.

Revenue: Revenue was less than $0.1 million for the quarters ended March 31, 2018 and 2017.

Net Loss: Net loss was $16.0 million, or $0.15 per share (basic and diluted), for the quarter ended March 31, 2018, compared to a net loss of $20.0 million, or $0.38 per share (basic and diluted), for the quarter ended March 31, 2017.

Conference Call Details

Regulus will host a conference call and webcast today at 5:00 p.m. Eastern Time to discuss first quarter financial results and provide a general business update. A live webcast of the call will be available online at www.regulusrx.com. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 8993969. To access the replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), conference ID 8993969. The webcast and telephone replay will be archived on the company’s website following the call

On May 10, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, reported that management will attend the following conferences (Press release, Aclaris Therapeutics, MAY 10, 2018, View Source [SID1234526461]):

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Management will host investor meetings during the Bank of America Merrill Lynch’s 2018 Healthcare Conference in Las Vegas, NV on Wednesday, May 16, 2018.

Dr. Neal Walker, President and Chief Executive Officer, will present at the Jefferies 2018 Healthcare Conference in New York, NY on Tuesday, June 5, 2018 at 1:30 PM EST. Management will also host investor meetings on Tuesday, June 5, 2018.

Dr. Neal Walker, President and Chief Executive Officer, will present at the William Blair 38th Annual Growth Stock Conference in Chicago, IL on Wednesday, June 13, 2018at 11:20 AM CT. Management will also host investor meetings on Wednesday, June 13, 2018.

Management will participate on panels and host investor meetings during the 2018 Cantor Dermatology & Aesthetics Summit in New York, NY on Tuesday, June 19, 2018.

Management will participate on a panel and host investor meetings during the 2018 JMP Securities Life Sciences Conference in New York, NY on Wednesday, June 20, 2018.
A live webcast of the Jefferies 2018 Healthcare Conference presentation and the William Blair 38th Annual Growth Stock Conference presentation may be accessed through the Company’s web site, www.aclaristx.com, on the ‘Events and Presentations’ section. An archived version of the presentation will be available for 30 days.

On May 10, 2018 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, reported financial results and recent corporate highlights for the first quarter ended March 31, 2018 (Press release, Fortress Biotech, MAY 10, 2018, View Source [SID1234526479]).

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "We have made significant advancements in the four years since we created and implemented our unique and efficient business model to benefit all stakeholders. The centralization of a number of critical corporate and R&D functions at Fortress allows our subsidiaries, or "Fortress Companies," to leverage internal synergies and minimize costs, so they can focus on getting drugs into the hands of people who need them. Our focus on continuing to build value through our strong business development engine and R&D team has led to the launch of nine development-stage subsidiaries, one specialty dermatology subsidiary and the in-licensing of more than 25 development-stage therapies since January 2014. The long-term success of our subsidiaries benefits Fortress through modest royalties on sales and annual and event-driven equity grants."

Dr. Rosenwald added, "By offering investment opportunities to finance specific Fortress Companies, we enable investors to select more concentrated exposure in innovative therapeutic areas, like CAR-T therapy and checkpoint inhibitors. We have done just that in the 18 months since we completed a successful tender offer for the majority of shares in National Holdings Corporation. This unique relationship enables us to offer National Holdings’ clients the opportunity to invest in drug candidates across a range of developmental stages and therapeutic areas. We are pleased with our synergistic collaboration with National Holdings and the significant progress National Holdings has made in the past 18 months to transform its firm culture."

Accomplishments since launch of Fortress business model in January 2014:

Research and development

Established 9 development-stage Fortress Companies in areas including CAR-T therapy, checkpoint inhibitors, gene therapy, rare diseases and pain management

Established Journey Medical Corporation, a specialty dermatology company with four marketed products (Targadox, Ceracade, Triderm and Luxamend) and a contract sales and marketing operation of more than 30 professionals

In-licensed more than 25 development-stage programs across multiple therapeutic areas, which are currently in development at Fortress and the Fortress Companies

Established a 27,000 sq. foot CAR-T processing facility at UMass Medicine Science Park in Worcester, Massachusetts, to manufacture Mustang Bio’s CAR-T therapies

Corporate

Established a business development / search and evaluate team, and expanded headcount to approximately 20 employees

Built a corporate operations team (finance, accounting, legal, investor relations and human resources) of 15 employees and expanded manufacturing, quality, regulatory, clinical and R&D staff to 34 employees

Financial Results:

As of March 31, 2018, Fortress’ consolidated cash, cash equivalents, short-term investments (certificates of deposit), cash deposits with clearing organizations and restricted cash totaled $179.4 million, compared to $168.3 million as of December 31, 2017, an increase of $11.1 million for the quarter.

Net revenue totaled $55.4 million for the first quarter of 2018, compared to $44.7 million for the first quarter of 2017. Total revenue as of March 31, 2018, includes $5.9 million of Fortress revenue and $49.5 million of revenue from National Holdings. Total revenue as of March 31, 2017, included $2.8 million of Fortress revenue and $41.9 million of revenue from National Holdings.

Research and development expenses were $25.0 million for the first quarter of 2018, of which $22.8 million was related to Fortress Companies. This compares to $7.1 million for the first quarter of 2017, of which $5.4 million was related to Fortress Companies. Non-cash, stock-based compensation expenses included in research and development were $2.3 million for the first quarter of 2018, compared to $0.8 million for the first quarter of 2017.

Research and development expenses from license acquisitions totaled $0.1 million for the first quarter of 2018, compared to $1.3 million for the first quarter of 2017.

General and administrative expenses were $13.5 million for the first quarter of 2018, of which $8.4 million was related to Fortress Companies. This compares to $10.3 million for the first quarter of 2017, of which $6.7 million was related to Fortress Companies. Non-cash, stock-based compensation expenses included in general and administrative expenses were $2.5 million for the first quarter of 2018, compared to $2.1 million for the first quarter of 2017.

National Holdings’ operating expenses totaled $50.8 million for the first quarter of 2018, compared to $43.1 million for the first quarter of 2017.

Net loss attributable to common stockholders was $21.0 million, or $0.49 per share, for the first quarter of 2018, compared to a net loss attributable to common stockholders of $12.0 million, or $0.30 per share, for the first quarter of 2017.

Recent Fortress and Fortress Company Highlights:

Aevitas Therapeutics, Inc.

In January 2018, Aevitas entered into a sponsored research agreement with the laboratory of Guangping Gao, Ph.D., at the University of Massachusetts Medical School to evaluate construct optimization for Aevitas’ AAV gene therapy treatment for complement-mediated diseases.

Avenue Therapeutics, Inc.

In March 2018, Avenue received Notices of Allowance from the U.S. Patent and Trademark Office ("USPTO") for three patent applications covering methods of administration for IV tramadol. Issuance of these patents is expected in the second quarter of 2018.

In April 2018, Avenue completed enrollment in its Phase 3, multicenter, randomized, double-blind, three-arm clinical trial evaluating the efficacy and safety of IV tramadol 50 mg and 25 mg versus placebo for the treatment of moderate to moderately severe pain in patients following bunionectomy surgery. Avenue expects to report topline data in the second quarter of 2018.

Caelum Biosciences, Inc.

In March 2018, a new analysis of data from the Phase 1b trial of Caelum’s CAEL-101 (mAb 11-1F4) for the treatment of relapsed or refractory amyloid light chain ("AL") amyloidosis was presented at the 16th International Symposium on Amyloidosis. The data demonstrated a correlation between a sustained decrease in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels and an improvement in global longitudinal strain ("GLS") following CAEL-101 treatment in patients with cardiac AL amyloidosis.

Checkpoint Therapeutics, Inc.

In March 2018, Checkpoint completed an underwritten public offering that raised net proceeds of $20.8 million.

Also in March 2018, Checkpoint completed the dose escalation portion of the ongoing Phase 1 trial of CK-301, a fully human anti-PD-L1 antibody, in selected recurrent or metastatic cancers, and initiated the first dose expansion cohort, which is evaluating an 800 mg dose of CK-301 administered every two weeks.

In April 2018, Checkpoint presented preclinical data on BET inhibitor CK-103 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. CK-103 demonstrated combinatorial effects in an in vivo model with anti-PD-1 antibodies, which may support the development of CK-103 as an anti-cancer agent alone and in combination with Checkpoint’s anti-PD-L1 antibody CK-301.

Mustang Bio, Inc.

In March 2018, Mustang announced that Sadik Kassim, Ph.D., was appointed Chief Scientific Officer, and Knut Niss, Ph.D., was named Chief Technology Officer.

National Holdings Corporation:

Fortress acquired approximately 57% of National Holdings Corporation ("National Holdings") in September 2016.
Accomplishments since closing the tender include:

Established new client-focused leadership team at National Holdings and at its wholly-owned operating companies National Securities Corporation and National Asset Management, Inc.;
Invested in new technology infrastructure geared toward risk management and improved client performance; and
Continued to increase revenues, particularly in investment banking, as described in its Q1 10-Q, filed February 14, 2018

On May 10, 2018 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported that Aoife Brennan, M.B., B.Ch., has accepted the position of Interim President and Chief Executive Officer of Synlogic, effective immediately (Press release, Synlogic, MAY 10, 2018, View Source [SID1234526495]).

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This appointment follows the resignation of Jose Carlos Gutiérrez-Ramos, Ph.D., as Synlogic’s President and Chief Executive Officer and a member of its board of directors. Dr. Gutiérrez-Ramos will serve in an advisory capacity as needed.

"On behalf of the entire board I would like to thank JC for his contributions to Synlogic, particularly in transitioning the Company from a research organization to a publicly traded, clinical-stage company, and we wish him well in his future endeavors," said Peter Barrett, chairman of Synlogic’s board of directors. "Aoife has done a remarkable job advancing our development efforts, and our board has complete confidence in her ability to lead the company on an interim basis as we conduct our search for a permanent CEO to drive the next stage of Synlogic’s growth. To aid in this transition, I will assume the role of Executive Chairman of the Board and will support Aoife as we continue to execute on Synlogic’s strategic priorities and advance the Company’s research, preclinical activities and ongoing clinical trials, which remain on track per the Company’s prior guidance."

"JC leaves us with a strong, well-funded organization, compelling science and clinical programs, and a world-class team. We greatly appreciate his efforts to bring Synlogic from discovery to a clinical development company and his guidance as a mentor and leader," said Dr. Brennan. "I look forward to working with the leadership team and our board to continue to advance our mission to develop novel living medicines that will change the lives of patients with serious and life-threatening diseases."