On July 31, 2018 Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies (RCTs) that may offer rapid-onset pain relief and restored function, reported the appointment of E. Lynne Kelley, M.D., FACS as its Chief Medical Officer (Press release, Histogenics, JUL 31, 2018, View Source;p=RssLanding&cat=news&id=2360905 [SID1234528656]). Dr. Kelley brings more than 20 years of executive management and surgical experience in medical affairs, clinical operations, regulatory affairs and product development to Histogenics. Dr. Kelley will join Histogenics’ executive team and assume responsibility for leading medical affairs strategy and building out the department in anticipation of NeoCart’s potential commercial launch. Dr. Kelley will also work with the team on preparing the anticipated Biologics License Application (BLA) for NeoCart and spearheading related discussions with the United States Food and Drug Administration (FDA).

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!

"Lynne’s experience as a surgeon, medical affairs executive and educator across a wide variety of therapeutic areas and indications will be critical for Histogenics as we prepare for our top-line data, potential BLA submission and FDA review of NeoCart," stated Adam Gridley, President and Chief Executive Officer of Histogenics. "We are pleased to have Lynne join us at this exciting time to educate our customers and patients about the benefits of our novel restorative cell therapy platform through training, medical education and collaboration with our future commercial team. In addition, she will be working closely with our team to help drive additional product development initiatives, such as future trials in the U.S. and internationally."

Dr. Kelley is a board certified general and vascular surgeon having received her medical degree from Dartmouth Medical School and completed her Residency in General Surgery at Dartmouth Hitchcock Medical Center. During her training she was awarded an NIH-sponsored basic science research grant at Harvard Medical School. She completed a Fellowship in Vascular Surgery at Harvard Medical School, Massachusetts General Hospital and was awarded the Marco Polo Fellowship providing advance training in Endovascular Surgery at the University Paris Hospital, Henri Mondor. Dr. Kelley also received a B.A. in Biology from Boston University. Prior to Histogenics, Dr. Kelley held various medical affairs roles within the industry including: Chief Medical Officer at Senseonics, World Wide Vice President of Medical Affairs at Becton Dickinson & Company Medical Surgical Systems Division, Vice President and Medical Director at Kimberly Clark, and Medical Director at Boston Scientific Corporation’s (Boston Scientific) Peripheral Interventions and Vascular Surgery division. Prior to her work at Boston Scientific, Dr. Kelley was an assistant professor of vascular surgery and radiology at Yale University.

"I am thrilled to join the talented, cutting edge team at Histogenics. The potential of NeoCart in restoring function and thus improving the lives of patients with debilitating joint pain is extraordinary," shared Dr. Kelley. "I look forward to collaborating with the physician community globally to bring this exciting therapy to our patients."

In connection with the hiring of Dr. Kelley, the Compensation Committee of Histogenics’ Board of Directors approved a grant to Dr. Kelley of a stock option to purchase 200,000 shares of Histogenics’ common stock. The option was granted pursuant to the Nasdaq inducement grant exception as a component of Dr. Kelley’s employment compensation, and was granted as an inducement material to her acceptance of employment with Histogenics in accordance with Nasdaq Listing Rule 5635(c)(4). The option will have an exercise price equal to the closing price of Histogenics’ common stock on July 31, 2018. The option has a ten year term and vests with respect to 25% of the shares of common stock underlying the option on the one year anniversary of Dr. Kelley’s first day of employment with Histogenics and with respect to the remaining shares in equal monthly installments over the following 36 months, subject to Dr. Kelley’s continued service with Histogenics through the applicable vesting dates.

On July 31, 2018 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that the Company will host a conference call and live webcast on Tuesday, August 7, 2018 at 5:00 p.m. EDT to report its second quarter 2018 financial results and provide a corporate update (Press release, Bellicum Pharmaceuticals, JUL 31, 2018, View Source [SID1234527971]).

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!

To access the call, participants should dial 877-407-3103 (U.S. domestic) and 201-493-6791 (international) at least 10 minutes prior to the start of the call. The event will be webcast live and can also be accessed in the Events & Presentations section of bellicum.com. An archived version of the webcast will be available for replay in the Investors & Media section of the Bellicum website for at least two weeks following the call.

On July 31, 2018 Geron Corporation (Nasdaq: GERN) reported financial results for the three and six months ended June 30, 2018 (Press release, Geron, JUL 31, 2018, View Source [SID1234528419]).

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!

Second Quarter and Year to Date 2018 Results

For the second quarter of 2018, the Company reported a net loss of $6.9 million, or $0.04 per share, compared to $6.4 million, or $0.04 per share, for the comparable 2017 period. Net loss for the first six months of 2018 was $14.1 million, or $0.08 per share, compared to $13.6 million, or $0.09 per share, for the comparable 2017 period.

Revenues for the three and six months ended June 30, 2018 were $208,000 and $526,000, respectively, compared to $174,000 and $711,000 for the comparable 2017 periods. Revenues for the three and six months ended June 30, 2018 and 2017 included royalty and license fee revenues under various non-imetelstat license agreements. The Company adopted the new revenue recognition accounting standard as of January 1, 2018 using the modified retrospective transition method. Financial results for the three and six months ended June 30, 2018 are presented under the new accounting standard, but prior period amounts have not been adjusted and continue to be reported under accounting standards used historically. Therefore, there is a lack of comparability to the prior periods presented. As a result, the decrease in revenues for the six months ended June 30, 2018, compared to the same period in 2017, reflects not only a reduction in the number of active non-imetelstat license agreements and decreased product sales from licensees, but also a change in the method accounting. However, the Company does not expect the adoption of the new revenue recognition accounting standard to have a material impact to its financial statements on an ongoing basis.

Total operating expenses for the three and six months ended June 30, 2018 were $7.4 million and $15.2 million, respectively, compared to $6.9 million and $14.9 million for the comparable 2017 periods. Research and development expenses for the three and six months ended June 30, 2018 were $3.2 million and $5.6 million, respectively, compared to $2.5 million and $5.9 million for the comparable 2017 periods. The changes in research and development expenses for the three and six months ended June 30, 2018, compared to the same periods in 2017, primarily reflect the variation in costs for our proportionate share of clinical development expenses under the imetelstat collaboration with Janssen Biotech, Inc. (Janssen). General and administrative expenses for the three and six months ended June 30, 2018 were $4.2 million and $9.6 million, respectively, compared to $4.4 million and $9.1 million for the comparable 2017 periods. The overall increase in general and administrative expenses for the six months ended June 30, 2018, compared to the same period in 2017, primarily reflects the net result of higher legal and consulting costs, partially offset by lower stock-based compensation expense.

Interest and other income for the three and six months ended June 30, 2018 was $717,000 and $1.1 million, respectively, compared to $346,000 and $678,000 for the comparable 2017 periods. The increase in interest and other income for the three and six months ended June 30, 2018, compared to the same periods in 2017, primarily reflects higher yields on the company’s increased marketable securities portfolio.

The Company ended the second quarter of 2018 with $181.4 million in cash and marketable securities. Since December 2017, the Company has raised cumulative net cash proceeds of approximately $87 million from the sales of an aggregate of 23,892,415 shares of common stock under At Market Issuance Sales Agreements (Sales Agreements) after deducting sales commissions and offering expenses payable by Geron. The Company expects these net cash proceeds to provide additional capital structure flexibility under different scenarios. If Janssen elects to continue the collaboration, the funds can potentially support the future shared development of imetelstat and Geron’s business development efforts to diversify its business through in-licensing or acquisitions. If Janssen elects to discontinue the collaboration, and Geron chooses to continue development of imetelstat, the funds can support future development costs, including potentially the start of the Phase 3 portion of IMerge.
Company Events

"We still expect Janssen’s decision whether to continue imetelstat development by the end of the third quarter," said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer. "During the second quarter, we strengthened our balance sheet and made progress on our plans to address either scenario resulting from Janssen’s decision. Therefore, we are confident in our ability to manage our business effectively going forward."

IMbark Status

IMbark is a Phase 2 trial in patients with Intermediate-2 or High Risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a JAK inhibitor. In March 2018, Janssen officially closed the trial to new patient enrollment. In the second quarter of 2018, Janssen initiated a protocol-specified primary analysis of IMbark, which includes an assessment of overall survival. The Company expects that following completion of the protocol-specified primary analysis, Janssen will notify Geron whether it elects to maintain the license rights and continue the development of imetelstat in any indication (the Continuation Decision). Geron expects Janssen to inform the Company of its decision by the end of the third quarter of 2018.

IMerge Status

IMerge is a two-part clinical trial evaluating imetelstat in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent, or ESA. The primary efficacy endpoint is the rate of red blood cell transfusion independence lasting at least 8 weeks. Part 1 is a Phase 2, open-label, single-arm trial of imetelstat, and Part 2 is designed to be a Phase 3, randomized, controlled trial. Part 2 has not yet begun.

On June 17, 2018, updated data from the original Part 1 of IMerge was presented at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) held in Stockholm, Sweden. The oral presentation described data as of May 2018 from the first 32 patients enrolled in Part 1 of IMerge with a median follow-up of 95 weeks. These data showed that among the 32 red blood cell transfusion-dependent MDS patients enrolled in Part 1, a subset of 13 patients, who had not received prior treatment with either a hypomethylating agent or lenalidomide and were non-del(5q), exhibited an increased rate and durability of transfusion independence compared to the overall trial population.

The slide presentation from the EHA (Free EHA Whitepaper) conference is available on Geron’s website at www.geron.com/r-d/publications.

Based on preliminary data from Part 1 of IMerge, Janssen expanded new patient enrollment in Part 1 and enrolled approximately 25 additional patients who are naïve to lenalidomide and HMA treatment and are non-del(5q) to increase the experience and evaluate the benefit-risk profile of imetelstat in this refined target patient population. In November 2017, the first patient was dosed in the expanded Part 1 of IMerge and enrollment was completed in February 2018.

Conference Call and Webcast

Geron will host a conference call to discuss second quarter financial results and recent events at 4:30 p.m. ET on Tuesday, July 31, 2018.

Participants may access the conference call live via telephone by dialing domestically +1 (877) 303-9139 or internationally +1 (760) 536-5195. The passcode is 9464589. A live, listen-only webcast will also be available through on the Company’s website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company’s website for 30 days.

On July 31, 2018 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that Christopher Haqq, M.D., Ph.D., the Company’s Executive Vice President of Research and Development and Chief Scientific Officer, will participate in a panel discussion at the Canaccord Genuity 38th Annual Growth Conference on Thursday, August 9, 2018 at 12:00 p.m. EDT (Press release, Atara Biotherapeutics, JUL 31, 2018, View Source [SID1234528633]). The conference will be held at the InterContinental Boston Hotel in Boston, MA.

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!

A live audio webcast of the panel discussion will be available by visiting the Investors section of the Atara website. An archived replay of the webcast will be available on the Company’s website for 14 days following the panel discussion.

On July 31, 2018 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Tuesday, August 7, 2018 to report its second quarter 2018 financial results and provide a corporate update (Press release, Syros Pharmaceuticals, JUL 31, 2018, View Source [SID1234528354]).

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!

To access the live conference call, please dial 866-595-4538 (domestic) or 636-812-6496 (international), and refer to conference ID 8675009. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.