On August 6, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will be presenting at the following investor conference during August and invited investors to participate by webcast (Press release, Exact Sciences, AUG 6, 2018, View Source [SID1234528468]).

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!

Canaccord Genuity 38th Annual Growth Conference, Boston
Presentation on Wednesday, Aug. 8, 2018, at 1 p.m. EDT

The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

On August 6, 2018 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported the completion of an underwritten public offering of 10,454,546 shares of its common stock, including 1,363,636 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares (Press release, BioCryst Pharmaceuticalsa, AUG 6, 2018, View Source [SID1234528782]). The gross proceeds from this offering to BioCryst, including from the shares sold pursuant to the underwriters’ option to purchase additional shares, were approximately $57.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by BioCryst. BioCryst expects to use the net proceeds of this offering for general corporate purposes, which may include, but are not limited to, funding worldwide development, manufacturing, regulatory and commercial activities for the prophylactic and acute BCX7353 programs, focusing primarily on the United States, European Union and Japan; the advancement of development activities of our fibrodysplasia ossificans progressiva ("FOP") and other preclinical rare disease program; post-approval commitments for RAPIVAB/ALPIVAB; and capital expenditures and general working capital needs.

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!

J.P. Morgan and Jefferies acted as joint book-running managers for the offering. JMP Securities acted as lead manager for the offering.

A shelf registration statement on Form S-3 relating to the shares of common stock described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC"). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

This offering was made by means of a prospectus supplement and related prospectus. A prospectus supplement relating to the offering has been filed with the SEC and is available on its website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone: 1-866-803-9204 or from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected].

On August 6, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported its second quarter and six months ended June 30, 2018 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, AUG 6, 2018, View Source;p=irol-newsArticle&ID=2362261 [SID1234528449]).

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 dosing of the first patient with lifileucel in Europe for the treatment of metastatic melanoma marked an important milestone for Iovance and our global development plans as we continue our mission to develop TIL therapy as a treatment option for cancer patients. In line with expansion of the TIL platform, we are initiating investigation of TIL therapy in several new indications with high unmet need, as part of our collaboration with MD Anderson," said Dr. Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "We continue to advance our four company-sponsored trials and intend to provide an update regarding our melanoma program later this year."

Recent Achievements

Manufacturing

Initiated manufacturing at Lonza, Netherlands in support of the melanoma and cervical clinical sites in Europe.
Clinical

Enrollment in the global Phase 2 metastatic melanoma study, C-144-01, continues and in June 2018, the company announced that it dosed the first patient with LN-144 (lifileucel) in Europe at a clinical trial site in the United Kingdom.
As part of a collaboration program, Iovance and MD Anderson Cancer Center (MDACC) initiated two new Phase 2 clinical studies. The first, 2017-0672 (NCT03449108), is studying LN-145 manufactured by Iovance using the company’s Gen 2 manufacturing process to treat patients with soft tissue sarcoma, osteosarcoma and platinum resistant ovarian cancer. The study is active and enrolling patients. The second study is expected to be activated before the end of 2018 and will use TIL manufactured by MDACC.
Iovance has expanded to over 70 clinical sites for its four company-sponsored studies.
Regulatory

As of the end of July 2018, Iovance has activated sites for its two clinical trials being conducted in Europe in five countries including the Netherlands, France, Hungary, Spain and the United Kingdom.
In early May 2018, the company was granted orphan-drug designation from the U.S. Food and Drug Administration (FDA) for autologous tumor infiltrating lymphocytes for the treatment of cervical cancer with a tumor size of greater than 2 cm in diameter.
Research

Iovance entered into a Research Collaboration Agreement with Roswell Park Cancer Institute for a pre-clinical collaboration to explore the potential for TIL therapy in bladder and other cancers.
Second Quarter 2018 Financial Results

Net loss for the second quarter ended June 30, 2018 was $30.7 million, or $0.34 per share, compared to net loss of $23.4 million, or $0.37 per share for the same period ended June 30, 2017.

Research and development expenses were $24.6 million for the second quarter ended June 30, 2018, an increase of $6.0 million compared to $18.6 million for the second quarter ended June 30, 2017. The increase in research and development expenses was primarily attributable to a $2.8 million increase in payroll and related expenses, including stock-based compensation expenses, due to a higher number of full time employees and dedicated consultants as we expanded our research efforts and clinical development programs. In addition, a $4.5 million increase occurred due to clinical trial costs because of higher patient enrollment and the number of clinical sites in the clinical trial of lifileucel, for the treatment of metastatic melanoma, and the ongoing clinical trials of LN-145 for the treatment of cervical, head and neck and lung cancers. These increases were partially offset by a $1.0 million decrease in manufacturing costs due to higher costs in 2017 related to technical transfer activities.

General and administrative expenses were $6.8 million for the quarter ended June 30, 2018, an increase of $1.9 million compared to $4.9 million for the second quarter ended June 30, 2017. The increase was primarily attributable to a $1.6 million increase in payroll and related expenses, including stock-based compensation expenses, due to an increase in head count and higher stock prices during the quarter, and a $0.3 million increase in professional service and legal expenses.

Six Months Ended June 30, 2018 Financial Results

Net loss for the six months ended June 30, 2018 was $ 57.2 million, or $0.65 per share, compared to net loss of $44.1 million, or $0.71 per share for the same period ended June 30, 2017.

Research and development expenses were $44.5 million for the six months ended June 30, 2018, an increase of $10.3 million compared to $34.2 million for the same period ended June 30, 2017. The increase in research and development expenses was primarily attributable to a $5.7 million increase in payroll and related expenses, including stock-based compensation expenses, primarily due to a higher number of full time employees and higher stock prices in 2018, and additional outside services contracted to perform research and development activities on our behalf, and a $7.0 million increase in costs related to our clinical trials as we expanded our clinical development programs into additional indications and added clinical trial sites in Europe. These increases were partially offset by a $2.0 million decrease in manufacturing costs due to higher costs in 2017 related to technical transfer activities.

General and administrative expenses were $13.8 million for the six months ended June 30, 2018, an increase of $3.6 million compared to $10.2 million for the same period ended June 30, 2017. The increase was primarily attributable to a $2.7 million increase in payroll and related expenses, including stock-based compensation expenses, due to a higher number of full time employees and higher stock prices in 2018, and a $0.5 million increase in legal expenses.

At June 30, 2018, the company held $276.1 million in cash, cash equivalents, and short-term investments compared to $297.1 million at March 31, 2018. During the second quarter the company used $24.0 million for operating activities. The company anticipates that the year-end balance of cash, cash equivalents and short-term investments may be between $190 to $210 million.

Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m. ET to discuss these second quarter and six months ended June 30, 2018 results and provide a corporate update. The conference call dial-in numbers are: 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID for the call is 5177499. The live webcast can be accessed under "News & Events" in the "Investors" section of the company’s website at View Source or you may use the link: View Source

A replay of the call will be available from August 6, 2018 at 7:30 p.m. ET to August 13, 2018 at 8:30 p.m. ET. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The reference access code is 5177499. The archived webcast will be available for thirty days in the Investors section of Iovance Biotherapeutics’ website at View Source

On August 6, 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 that the company will host a conference call and live audio webcast on Monday, August 13, 2018 at 5:00 p.m. ET to discuss financial results for the second quarter of 2018 (Press release, Unum Therapeutics, AUG 6, 2018, View Sourcenews-releases/news-release-details/unum-therapeutics-host-second-quarter-2018-financial-results" target="_blank" title="View Sourcenews-releases/news-release-details/unum-therapeutics-host-second-quarter-2018-financial-results" rel="nofollow">View Source [SID1234528469]). Unum management will also provide an update on the Company’s recent progress and upcoming milestones.

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!

Participants may access the conference call by dialing 866-300-3411 (domestic) or 636-812-6658 (international) and refer to conference ID number 2367857. To join the live webcast, please visit the investor relations section of the Unum Therapeutics website at View Source at least 10 minutes before the event begins.

A webcast replay will be available at the same location on the Unum Therapeutics website beginning approximately two hours after the event, and will be archived for 90 days.

On August 6, 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 second quarter ended June 30, 2018 (Press release, Fate Therapeutics, AUG 6, 2018, View Source [SID1234528450]).

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!

"Our submission to the FDA of an IND application for FT500, a universal, off-the-shelf NK cell cancer immunotherapy derived from a master iPSC line, is a significant milestone for the Company and the field of cell therapy," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We are excited to be working with the FDA to allow the first U.S. clinical investigation of an iPSC-derived cell therapy and usher in a new era enabling the development, manufacture and delivery of off-the-shelf cell products for the treatment of cancer. I am very pleased with our execution over the first six months of 2018 across the business, as we have also accelerated enrollment in our Phase 2 PROTECT study of ProTmune and expanded our clinical investigation of NK100 to a second leading cancer research center."

Clinical Programs

Treated 20th Subject in Phase 2 PROTECT Study of ProTmune. During the second quarter of 2018, 14 subjects were treated in the randomized, controlled and double-blinded Phase 2 PROTECT study, which is intended to enroll a total of 60 adult subjects with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). Subjects in the Phase 2 PROTECT study are being randomized, in a 1:1 ratio, to receive either ProTmune, the Company’s next-generation hematopoietic cell graft, or a conventional matched unrelated donor cell graft. The Company has submitted an abstract to present clinical data from the seven subjects that were administered ProTmune in the Phase 1 stage of PROTECT, including data on a key secondary endpoint assessing freedom from chronic graft-versus-host disease (GvHD), cancer relapse and death at 1-year following HCT, at the 2018 ASH (Free ASH Whitepaper) Annual Meeting.
Expanded Enrollment of FATE-NK100 Dimension Study to Baylor University Medical Center. The Company has now enrolled subjects in the Phase 1 DIMENSION study at two of the nation’s leading cancer research centers, Baylor Charles A. Sammons Cancer Center in Dallas and the Masonic Cancer Center, University of Minnesota. The DIMENSION study 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. Three Phase 1 clinical trials of NK100 are currently being conducted in subjects with advanced liquid and solid tumors, and the Company plans to present additional clinical data for NK100 in the second half of 2018.
Universal Off-the-Shelf Cancer Immunotherapy Preclinical Pipeline

Submitted First-of-Kind IND Application to FDA for FT500. Within the last thirty days, the Company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for FT500, a universal, off-the-shelf NK cell product. FT500 is the first product candidate emerging from the Company’s industry-leading induced pluripotent stem cell (iPSC) product platform, which uses clonal master iPSC lines as a renewable source for producing off-the-shelf cellular immunotherapies. The Company plans to clinically investigate FT500 in combination with FDA-approved checkpoint inhibitors as a rescue therapy.
Gained Rights to Novel CAR Constructs and CRISPR Gene-Editing from MSK. In May, the Company expanded its existing license agreement with Memorial Sloan Kettering Cancer Center (MSK) to further enable the development of off-the-shelf CAR T-cell immunotherapies, including the Company’s universal, off-the-shelf CAR19 T-cell product candidate FT819. The newly-licensed portfolio of intellectual property covers certain patents and patent applications relating to novel chimeric antigen receptor (CAR) constructs and off-the-shelf CAR T cells, including the use of CRISPR and other innovative technologies for their production. In connection with amending the license agreement, Fate Therapeutics paid an upfront fee of $500,000 and issued 500,000 shares of the Company’s common stock valued at $4.8 million to MSK, and MSK returned its entire interest in Tfinity Therapeutics, Inc. to the Company.
Organization

Promoted Bob Valamehr, Ph.D. to Chief Development Officer. Dr. Valamehr joined Fate Therapeutics in 2009 and oversees the Company’s iPSC product platform, including the development of the Company’s off-the-shelf NK cell and T-cell cancer immunotherapy pipeline. He is first author on the Company’s 2014 seminal publication in Stem Cell Reports describing the Company’s ground-breaking approach to the footprint-free generation, clonal selection and master cell banking of human iPSCs (View Source).
Appointed Michael Lee to Board of Directors. Mr. Lee is co-founder of and has served as a portfolio manager at Redmile Group, LLC, a health care-focused investment firm based in San Francisco and New York, since 2007.
Second Quarter 2018 Financial Results

Cash & Short-term Investment Position: Cash, cash equivalents and short-term investments as of June 30, 2018 were $78.0 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 second 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 $16.8 million for the second quarter of 2018, compared to $7.9 million for the same period in 2017. In the second quarter of 2018, the Company incurred a one-time $5.3 million expense associated with the in-license of additional intellectual property from MSK. The remaining increase in R&D expenses was primarily attributable to an increase in expenses associated with the clinical development of FATE-NK100 and with regulatory and manufacturing activities to support the submission of the FT500 IND application.
G&A Expenses: General and administrative expenses were $3.8 million for the second quarter of 2018, compared to $2.7 million for the same period in 2017. The increase in G&A expenses was primarily attributable to an increase in employee compensation associated with growth in headcount and in intellectual property-related expenses.
Shares Outstanding: Common shares outstanding were 53.4 million as of June 30, 2018 and 52.6 million as of December 31, 2017. Preferred shares outstanding as of June 30, 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, Monday, August 6th, 2018 at 5:00 p.m. ET to review financial and operating results for the quarter ended June 30, 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 2383816. 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 patients in an off-the-shelf manner. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 pending patent applications.