On August 1, 2018 Cell Medica (or ‘the Company’), a leader in the development, manufacture and marketing of personalised cellular immunotherapeutics for the treatment of cancer, reported that it has appointed Chris Nowers as Chief Executive Officer and Executive Director (Press release, Cell Medica, AUG 1, 2018, https://cellmedica.com/press-releases/cell-medica-appoints-new-ceo-drive-car-tcr-clinical-development-commercialisation/ [SID1234528417]). His appointment follows founder Gregg Sando’s decision to step down as Chief Executive Officer and Director of the Company and is effective 1 August 2018.

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Mr Nowers joins Cell Medica from the cancer immunotherapy company Kite Pharma (Kite), where he was Head of Europe and responsible for the full commercialisation of the CAR-T therapy axicabtagene ciloleucel. At Kite he built the European organisation from the ground up and, post the $12 Bn acquisition by Gilead Sciences in 2017, was subsequently responsible for the continued expansion of the Kite organisation within the Europe, Middle East and Africa structure. Previous to his role at Kite, he has had a career spanning more than 25 years in the biopharma industry. He has held a number of senior leadership roles that included CEO of Avantogen Oncology, General Management roles at Amgen, and senior global and regional commercial leadership roles at Bristol-Myers Squibb (BMS). Whilst at BMS, he built and led teams that delivered the successful launches of the checkpoint inhibitors ipilimumab and nivolumab.

Mr Sando, a pioneer in the field of cellular immunotherapy, established Cell Medica in 2006 and led the company’s transition into the CAR-T technology space. The upcoming initiation of clinical trials investigating CAR-modified cell therapy products will mark an important new chapter in the Company’s development. He will assist over the coming months in transitioning to new senior leadership.

Annalisa Jenkins, Chair of Cell Medica, commented:

"We would like to thank Gregg for his vision and commitment over the last 12 years, which has led to Cell Medica becoming a leader in cellular immunotherapy for cancer. He has built an experienced international team with the capability to build on existing research partnerships and develop the internal pipeline to maximise shareholder value.

"We are pleased to welcome Chris as Cell Medica’s new CEO. His experience in the commercialisation of oncology programmes is an excellent fit for the Company’s ambitions as we progress towards realising our goals of delivering compelling new cellular immunotherapies for the treatment of cancer patients."

Gregg Sando commented:

"It has been a great experience founding Cell Medica and leading a team of dedicated colleagues and research collaborators who have been working together to transform the treatment of cancer through cell-based immunotherapy. The Company is well positioned for an exciting future and it is now time to transition to new leadership who will take our products and technology through clinical development and commercialisation. My thanks and appreciation to the extended Cell Medica team and partners, past and present."

Chris Nowers commented:

"Cell Medica has an exciting array of technologies that will help unlock the potential of personalised cellular immunotherapies for both blood cancers and solid tumours. I look forward to working with the Company’s talented executive and scientific teams to take these promising treatments to patients through clinical development."

On August 1, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $102.9 million and completed approximately 215,000 Cologuard tests during the quarter ended June 30, 2018 (Press release, Exact Sciences, AUG 1, 2018, View Source [SID1234528655]). Second-quarter 2018 revenue and Cologuard test volume grew by 78 percent and 59 percent, respectively, from the same period of 2017.

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"We are excited about the continued growth of our physician ordering base, as well as their increasing Cologuard utilization, which led to a record quarter for revenue, volume and gross profit," said Kevin Conroy, chairman and CEO of Exact Sciences. "We are optimistic about the company’s future, including the opportunity to expand Cologuard’s label to reach even more people in the 45 to 49 age group, given the American Cancer Society’s recent guideline update."

Second-Quarter 2018 Financial Results

For the three-month period ended June 30, 2018, as compared to the same period of 2017 (where applicable):

· Revenue was $102.9 million, an increase of 78 percent, and test volume was 215,000, an increase of 59 percent

· Average recognized revenue per test was $479, an improvement of 12 percent

· Average cost per test was $125, an improvement of 6 percent

· Gross margin was 74 percent, an increase of 510 basis points

· Operating expenses were $108.7 million, an increase of 53 percent

· Net loss was $36.4 million or $0.30 per share, compared to $30.8 million or $0.27 per share

· Non-cash interest expense related to convertible debt was $6.7 million, or $0.05 per share

· Cash utilization was $45.3 million, compared to $43.9 million

· Cash, cash equivalents and marketable securities were $1.2 billion at the end of the quarter

· More than 10,000 healthcare providers ordered their first Cologuard test during the second quarter, and nearly 121,000 have ordered since the test was launched

2018 Outlook

· The company continues to anticipate revenue of $420-$430 million for 2018

The company’s guidance for revenue is a forward-looking statement. It is subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets. There can be no assurance the company will meet these financial projections. See the cautionary information about forward-looking statements in the "Safe Harbor Statement" section of this press release.

Second-Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Wednesday, Aug. 1, 2018, at 5 p.m. ET to discuss second-quarter 2018 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 877-201-0168 and international callers should dial +1-647-788-4901.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 4260268. The webcast, conference call and replay are open to all interested parties.

About Cologuard

Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2014) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy.

Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

On July 31, 2018 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported that it will report its second quarter 2018 financial and operating results after the close of U.S. financial markets on Tuesday, August 7, 2018 (Press release, Alder Biopharmaceuticals, JUL 31, 2018, http://investor.alderbio.com/news-releases/news-release-details/alder-biopharmaceuticalsr-host-conference-call-discuss-second-0 [SID1234528026]). Alder management will host a conference call and live audio webcast with accompanying slides to discuss the results and provide a general business update at 5:00 p.m. ET the same day.

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The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers and providing conference ID number 9588479. The webcast and accompanying slides can be accessed from the Events & Presentations page of the Investors section of Alder’s website at www.alderbio.com and will be available for replay following the call for at least 30 days.

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).

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"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]).

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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.