Array BioPharma to Report Financial Results for the Third Quarter of Fiscal 2019 on May 7, 2019

On April 30, 2019 Array BioPharma Inc. (Nasdaq: ARRY) reported that it will report financial results for the third quarter of fiscal 2019 and hold a conference call to discuss those results on Tuesday, May 7, 2019 at 9:00 am ET (Press release, Array BioPharma, APR 30, 2019, View Source [SID1234535482]).

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Date:

Tuesday, May 7, 2019

Time:

9:00 a.m. Eastern Time

Toll-Free:

(844) 464-3927

Toll:

(765) 507-2598

Pass Code:

3638409

Webcast, including Replay and Conference Call Slides:

View Source

Theravance Biopharma to Report First Quarter 2019 Financial Results on May 7

On April 30, 2019 Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") reported that it will release financial results for the period ended March 31, 2019 and provide a business update after market close on Tuesday, May 7, 2019 (Press release, Theravance, APR 30, 2019, View Source [SID1234535481]).

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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

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An accompanying conference call will be held at 5:00 pm ET on May 7, 2019. To participate in the live call by telephone, please dial (855) 296-9648 from the US, or (920) 663-6266 for international callers, using the confirmation code 9890346. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investor Relations section, Presentations and Events. Please go to the website 15 minutes prior to the start of the call to register, download, and install any necessary audio software.

A replay of the conference call will be available on Theravance Biopharma’s website for 30 days through June 6, 2019. An audio replay will also be available through 8:00 pm ET on May 14, 2019 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 9890346.

Synthetic Biologics to Report 2019 First Quarter Operational Highlights and Financial Results on May 8, 2019

On April 30, 2019 Synthetic Biologics, Inc. (NYSE American: SYN), a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, reported that the Company intends to release its operational highlights and financial results for the quarter ended March 31, 2019 on Wednesday, May 8, 2019, and to host a conference call the same day at 4:30 p.m. ET (Press release, Synthetic Biologics, APR 30, 2019, View Source [SID1234535480]). The dial-in information for the call is as follows:

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U.S. (toll free): 1-888-347-5280
International: +1 412-902-4280

Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archived replay of the call will be available for approximately ninety (90) days at the same URL, View Source beginning approximately one hour after the call’s conclusion.

Cellular Biomedicine Group Reports First Quarter 2019 Results and Highlights Operational Progress

On April 30, 2019 Cellular Biomedicine Group, Inc. (Nasdaq: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported its financial results and business highlights for the first quarter ended March 31, 2019 (Press release, Cellular Biomedicine Group, APR 30, 2019, View Source [SID1234535479]).

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"Early in 2019, we achieved the first of many milestones anticipated for this year in support of our immuno-oncology platform, as we initiated patient recruitment for our Phase I trial of anti-BCMA CAR-T therapy targeting multiple myeloma in China. We are also on track with the technology transfer from the strategic licensing and collaboration agreement that we signed during the 2018 third quarter with a global leader in CAR-T cell therapy for patients in China," commented Tony Liu, Chief Executive Officer of CBMG. "In addition to the AFP-TCR and TIL solid tumor platform, in 2019 we plan to initiate clinical development for CAR-T programs for CD22, CD20 and NKG2D for hematological cancers, and AFP TCR-T for metastatic HCC. Also during the first quarter, significant progress was made with our Stem Cell Platform as our IND application for AlloJoin for KOA became the first stem cell drug application to be approved by China’s CDE for a Phase II KOA clinical trial since the new Regulation’s release*. Our broad clinical development programs and investments into our in-house research, manufacturing capabilities and our CMC platform remain a key part of our strategy to realize the potential of CAR-T cell therapies for patients suffering from various cancers."

* China NMPA (formerly CFDA) clarified Cell Therapy Regulations in December 2017 (the "Regulation") whereby all cell therapies are being treated as drug NDA/IND.

First Quarter 2019 Financial Performance

Cash Position: Cash position as of March 31, 2019 was $62 million (including restricted cash) compared to $52.8 million as of December 31, 2018;
Net Cash Used in Operating Activities: Net cash used in operating activities for the first quarter of 2019 was $7.9 million, compared to $5.6 million for the same period in 2018, a 41% increase;
G&A Expenses: General and administrative expenses for the first quarter of 2019 were $3.4 million compared to $3.2 million for the same period in 2018, an 8% increase;
R&D Expenses: Research and development expenses for the first quarter of 2019 were $6.0 million, compared to $5.3 million for the same period a year ago, a 13% increase. The increase was primarily due the increased spending in the growth of our pipeline in both liquid tumor and solid tumor development;
Net Loss: Net loss allocable to common stock holders was $9.3 million, compared to $8.5 million for the same period in 2018, a 10% increase.
In January 2019, China Merchants Bank granted the Company a credit up to RMB 100 million (approximately $14.7 million) via revolving and/or one-time credit lines, which period runs until December 30, 2019. As of March 31, 2019, $6.1 million had been drawn down under this banking facility.
Conference Call and Webcast Information

The Company will host a conference call and webcast with the investment community on Wednesday, May 1st at 8:30 a.m. Eastern Time / 8:30 p.m. China Standard Time featuring remarks by Tony Liu, Executive Director, CEO and CFO of CBMG.

Live Call:

Toll-Free: 1-877-423-9813

International: 1-201-689-8573

Webcast:

View Source

Replay:

Toll-Free: 1-844-512-2921

International: 1-412-317-6671

Conference ID: 13690103

(Available approximately two hours after the completion of the live call until 11:59 p.m. ET on May 15, 2019)

Pulse Biosciences Quarterly Investor Conference Call

On April 30, 2019 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company"), a novel bioelectric medicine company bringing to market its proprietary CellFX System, reported recent corporate developments and financial results for the quarter ended March 31, 2019 (Press release, Pulse Biosciences, APR 30, 2019, View Source [SID1234535477]).

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Recent Corporate Developments

Pre-market Notification (510(k)) submitted to the U.S. Food and Drug Administration (FDA) for its proprietary CellFX System seeking clearance for commercial use in common dermatologic procedures to remove general benign lesions including Sebaceous Hyperplasia, a common but difficult-to-treat facial lesion and Seborrheic Keratosis, a common benign pigmented lesion. This afternoon we received an additional information ("AI") letter request from FDA, and the FDA among other things is questioning the adequacy of the predicate device provided in the 510(k). Responding to this request will add time and require additional testing, inclusive of clinical trials. In consideration of the above we are presently evaluating an alternative approach, the De Novo process approach, which would also likely require additional time, testing and clinical studies. At the end of the day the De Novo approach may be in the best interest of Pulse Biosciences. We will update on this important matter no later than the upcoming Annual Meeting of Stockholders scheduled for May 16, 2019.
Mitchell Levinson, a well-seasoned entrepreneur and executive in the aesthetic procedure market, appointed to the Board of Directors.
Podium presentations by key opinion leaders in aesthetic dermatology speaking to the novel mechanism of action of the CellFX System and the positive results from our clinical studies in Sebaceous Hyperplasia and Common Warts at the American Academy of Dermatology Annual Meeting and the American Society for Laser Medicine and Surgery Annual Conference.
Continued progress in active feasibility studies including Common Warts, Back Acne and Basal Cell Carcinoma.
"At Pulse Biosciences we remain focused on commercializing our CellFX System in aesthetic dermatology and we are pleased with our progress towards this goal in Q1," said Darrin Uecker, Pulse Biosciences’ President and Chief Executive Officer.

Financial Highlights

Cash, cash equivalents, and investments totaled $52.8 million at March 31, 2019, compared to $59.6 million at December 31, 2018. Cash use totaled $6.8 million for the first quarter of 2019 compared to cash use of $6.4 million for the fourth quarter of 2018, and $4.7 million for the first quarter of 2018.

Operating expenses for the three-month period ended March 31, 2019 was $10.4 million, compared to $8.7 million for the three-month period ended March 31, 2018. The operating expenses for the three-month period ended March 31, 2019 included non-cash stock-based compensation of $2.4 million, compared to non-cash stock-based compensation of $3.4 million for the three-month period ended March 31, 2018.

Net Loss for the three-month period ended March 31, 2019 totaled $10.1 million, compared to $8.7 million for the three-month period ended March 31, 2018.

Conference Call Details

Pulse Biosciences will host an investor call on April 30, 2019, at 1:30 p.m. PDT / 4:30 p.m. EDT. The telephone dial-in number for the call is (844) 494-0190 (U.S. toll-free) or (508) 637-5580 (international) using Conference ID 3466369. Listeners will also be able to access the call via webcast available on the Investors section of the Company’s website at www.PulseBiosciences.com.