On May 10, 2018 FORMA Therapeutics (FORMA), a fully-integrated research and development biotechnology company, reported an abstract featuring the company’s selective, small molecule IDH1m inhibitor, FT-2102, has been selected for an oral presentation at the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held from June 1-5, 2018 in Chicago, Illinois (Press release, Forma Therapeutics, MAY 10, 2018, View Source [SID1234526429]). Details on the presentation are included below.

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Date and Time: Monday, June 4, 2018, 4:30 PM – 6:00 PM

Session Title: Targeted Therapy in Leukemia

Session Type: Oral Abstract Session Title: A phase 1 dose escalation study of the IDH1m inhibitor, FT-2102, in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Abstract No.: 7009

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.

1

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 9, 2018 Pain Therapeutics, Inc. (Nasdaq:PTIE), a drug development company, reported financial results for the first quarter ended March 31, 2018 (Press release, Pain Therapeutics, MAY 9, 2018, View Source [SID1234526317]). Net loss was $2.2 million, or $0.33 per share. This compared to a net loss of $2.7 million, or $0.42 per share, for the same period in the prior year. Cash and cash equivalents were $10.7 million as of March 31, 2018.

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"FDA’s acceptance of the NDA filing for REMOXY ER in Q1 2018 is a milestone," said Remi Barbier, Chairman, President & CEO. "Our focus is now on REMOXY ER’s potential to receive marketing clearance later this year. As part of this focus, we are preparing a strategic and thorough presentation of our key data for an upcoming FDA Advisory Committee Meeting for REMOXY ER, scheduled for June 26th in Washington, DC. We also continue to maintain tight fiscal discipline, and to advance our early-stage programs with non-dilutive funding."

Financial Highlights for First Quarter 2018

Net loss for the quarter was $2.2 million, or a net loss per share of $0.33. This compared to a net loss of $2.7 million, or $0.42 per share, for the same period in the prior year, representing a 19% decrease.

Cash and cash equivalents were $10.7 million. This compared to $10.5 million in the prior quarter, representing a 2% increase. Cash and cash equivalents for the quarter includes $1.9 million of net proceeds raised through issuance of shares of our common stock under a Capital on DemandTM program with JonesTrading Institutional Services LLC.

We have no debt.

We believe existing capital resources are sufficient to meet our projected operating requirements for at least the next 12 months.

We received $0.4 million in research grant funding from the National Institutes of Health, recorded as a reduction in research and development expenses (R&D).

R&D expenses were $1.1 million. This compared to $1.4 million for the same period in the prior year, representing a 23% decrease. R&D expenses included non-cash stock related compensation costs of $0.4 million, versus $0.3 million for the same period in the prior year.

General and administrative (G&A) expenses were $1.1 million. This compared to $1.4 million for the same period in the prior year, representing a 20% decrease. G&A expenses included non-cash stock-related compensation costs of $0.5 million, versus $0.5 million for the same period in the prior year.

About REMOXY ER (extended-release oxycodone capsules CII)

REMOXY ER is in registration with the US Food and Drug Administration (FDA) as a new type of abuse-deterrent, twice-daily, capsule gel formulation of oral oxycodone, a strong opioid drug. REMOXY ER has physical/chemical properties intended to deter abuse and still provide 12 hours of steady pain relief when properly prescribed by physician and used appropriately by patients.

Studies were extensive. The clinical efficacy of REMOXY ER was established in a Phase III study conducted under a Special Protocol Assessment. In total, over 2,400 subjects were exposed to REMOXY ER in 30 clinical studies. 9,000 unique data points were generated from 11 lab studies. The assessment of REMOXY ER’s abuse deterrence is supported by data from FDA Category 1 (lab), Category 2 (pharmacokinetic) and Category 3 (human abuse potential) studies. In addition, in November 2017 the Company and FDA held a pre-NDA meeting to confirm the sufficiency of data included in the REMOXY ER NDA resubmission.

REMOXY ER has a thick, sticky, high viscosity, hydrophobic, gel formulation that abusers cannot cut, grate or divide into smaller discrete particle sizes. The gel formulation resists syringe-ability, injection, and rapid extraction in ingestible solvents. REMOXY ER’s high viscosity and adhesive properties also cause it to stick to tools and equipment used for abuse. When exposed to heat, REMOXY ER releases an irritant to the eyes and lungs. REMOXY ER resists dose-dumping when challenged by alcohol and common physical and chemical manipulations.

We are requesting marketing approval of REMOXY ER as an analgesic drug with properties that can be expected to deter against injection, snorting and inhalation/smoking routes of abuse.

REMOXY ER intends to address the public health epidemic related to prescription opioids by advancing the science of abuse deterrence, providing an additional treatment option for physicians and patients, and increasing the range of available abuse deterrent technologies.

About Opioid Abuse
Opioid drugs such as oxycodone are an important treatment option for patients with severe chronic pain. However, oxycodone abuse and diversion remain serious, persistent problems. Opioid overdose deaths exceeded 64,000 in 2016, according to the Center for Disease Control (CDC). For over a decade, Pain Therapeutics has pioneered Abuse-Deterrent Formulations (ADFs) to help in the fight against prescription drug abuse. ADFs attempt to raise the bar on prescription drug abuse by making it more difficult, longer or aversive to tamper with long-acting opioid formulations, recognizing that no drug can be made abuse-proof.

Our Pipeline of Drug Assets also Includes:
FENROCK (transdermal fentanyl patch system) – This is a proprietary, abuse-deterrent skin patch for severe pain. FENROCK is an early-stage program, substantially funded by a research grant award from National Institute on Drug Abuse (NIDA).

PTI-125 – This proprietary, small molecule drug candidate is aimed at the treatment of Alzheimer’s disease. PTI-125 is a Phase I clinical-stage program, substantially funded by a research grant award from the National Institutes of Health (NIH).

PTI-125DX – This is a proprietary blood-based test to detect Alzheimer’s disease. PTI-125DX is an early-stage program, substantially funded by a research grant award from the NIH

On May 9, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported The Lancet Oncology publication of data on 30 patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) treated with 177Lu-PSMA-617 (Press release, Endocyte, MAY 9, 2018, View Source [SID1234526367]). Preliminary results of this open-label phase 2 investigator-initiated trial were previously announced at the 2017 ESMO (Free ESMO Whitepaper) Congress and presented by Professor Michael Hofman of the Peter MacCallum Cancer Centre (Melbourne, Australia).

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"This more detailed publication was consistent with or improved from the summary results presented at ESMO (Free ESMO Whitepaper) last fall," said Mike Sherman, president and CEO of Endocyte. "The response rates demonstrated to date are encouraging, especially since no agent has been proven to improve survival in this heavily pre-treated patient population. We look forward to beginning enrollment in our global phase 3 VISION trial of 177Lu-PSMA-617 this quarter."

Mr. Sherman continued, "We also look forward to Professor Hofman presenting additional updates at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June, with new data from the trial’s expansion to 50 patients. Given the expected immaturity of survival data in the additional 20 patients, our focus will be on the PSA and RECIST response rates."

Updated Data Disclosed in The Lancet Oncology

The journal article published today in The Lancet Oncology reviews the design and results to date of the original 30 patients from this phase 2 trial. This publication provides a more comprehensive summary than previously disclosed of patient characteristics, treatment regimen and more mature outcome data, including updated Kaplan-Meier curves estimating overall survival and PSA progression-free survival (PFS) as well as a swimmer’s plot of the 30 patients.

This study evaluated a heavily pre-treated patient population, 87% of which had received > 1 line of prior chemotherapy (80% docetaxel and 47% cabazitaxel) and 83% received prior abiraterone acetate and/or enzalutamide.

Observations in this study include a PSA reduction of at least 50% from baseline (PSA50) in 57% of patients, a PSA reduction of at least 80% from baseline (PSA80) in 43% of patients and a PSA reduction of > 96% in 20% of patients who were identified as ‘exceptional responders’. Regarding disease progression and survival, a median PSA PFS of 7.6 months and a median overall survival (OS) of 13.5 months were observed. Both the median PSA PFS and the median OS reflect improved outcomes versus the 6.3 months and 12.7 months for each endpoint, respectively, previously presented at the 2017 ESMO (Free ESMO Whitepaper) Congress.

Notably, patients with a PSA50 response had median PSA PFS of 9.9 months and median OS of 17.0 months compared to PSA PFS of 4.1 months and median OS of 9.9 months for those who did not achieve a PSA50 response. Additionally, clinically meaningful improvements in quality of life measures were observed.

17 patients (57%) had prostate cancer working group 2 (PCWG2) RECIST 1.1 evaluable nodal or visceral target lesions following CT scan at baseline. Confirmed objective responses were seen in 14 (82%) of these 17 patients, including complete and partial response rates of 29% and 53%, respectively. This response rate is greater than the 71% PCWG2 RECIST 1.1 objective response rate previously reported.

177Lu-PSMA-617 was well tolerated, with no significant dose-limiting toxicities observed. The most common treatment-related toxicity was Grade 1 xerostomia (dry mouth) seen in 87% of patients, which is higher than previously reported (63%), but generally didn’t require any intervention. The occurrence of treatment-related Grade 3-4 hematologic toxicity was low and comparable to the largest retrospective published cohort.1

The paper is available online at the following link: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30198-0/supplemental

Website Information

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.