On November 6, 2019 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three months ended September 30, 2019 (Press release, Athersys, NOV 6, 2019, View Source [SID1234550442]).

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Highlights of the third quarter of 2019 and recent events include:

Steady advancement of both MultiStem ischemic stroke clinical trials, including the HEALIOS K.K. ("Healios") TREASURE study in Japan and in our Phase 3 registrational study MASTERS-2;

Continued support for the Healios’ acute respiratory distress syndrome ("ARDS") trial, the ONE-BRIDGE study in Japan, which continues to have steady enrollment;

Completion of one-year follow up assessments for our ARDS trial, the MUST-ARDS study, and initiation of planning for subsequent ARDS trial;

Advanced preparations for planned Phase 2 trauma clinical study;

Progressed planning for commercial readiness with our manufacturing process, technical transfer operations and future manufacturing plans;

Engaged in partnering discussions with companies interested in MultiStem commercialization rights in Europe and other regions;

MultiStem recognized in the first ESOT Leonardo Da Vinci Research Innovation Award received by Emily R. Thompson from the University of Newcastle for her work using MultiStem in human kidney transplant research;

Entered in new equity facility that will replace the current facility, providing us with access of up to $100 million to support operational and other initiatives over the next several years;

Recognized revenues of negative $0.4 million and net loss of $12.0 million, or $0.08 net loss per share, for the quarter ended September 30, 2019; and

Ended the 2019 third quarter with $40.4 million of cash and cash equivalents.

"We continue to make steady progress in our ongoing clinical programs, maintaining our focus on the critical care indications where our prior clinical results and extensive preclinical data suggest there is an excellent opportunity for MultiStem to address substantial areas of unmet medical need. Each of the indications we are focused on represent significant market opportunities, where current standard of care is limited, cost of care is high, and the disability burden and the quality of life impact on the patient and family is substantial," commented Dr. Gil Van Bokkelen, Chairman & CEO of Athersys. "We believe that MultiStem can help address substantial gaps and limitations in current standard of care, meaningfully improving clinical outcomes for patients, and delivering substantial value to the healthcare system.

"We are also heavily focused on strategic partnering activities in Europe and other geographies of interest, while we also pursue other strategic opportunities that have the potential to add value and strengthen our balance sheet. We are focused on preparing for commercialization in the future and maintaining a strong financial position while we pursue these initiatives," concluded Dr. Van Bokkelen.

Third Quarter Results
Our revenues are generally derived from license fees, manufacturing-related activities for Healios, other contract revenue from our collaborations and grant revenue. Revenues were negative $0.4 million for the three months ended September 30, 2019 compared to $2.3 million for the three months ended September 30, 2018, which were primarily related to our collaboration with Healios. In the third quarter of 2019, we determined that the estimated variable transaction price of product supply decreased due to a reduction in the underlying cost per dose that occurred during the quarter. This reduction exceeded the amount of revenue generated during the quarter. Royalty revenue ceased late in 2018 upon a licensee’s decision to discontinue distribution of the licensed product.
Research and development expenses decreased to $8.9 million for the three months ended September 30, 2019 from $9.5 million for the comparable period in 2018. The $0.6 million net decrease is associated with decreases in clinical trial and manufacturing process development costs of $1.1 million and license fees of $0.2 million, with such decreases partially offset by increases in personnel costs of $0.2 million, outside services of $0.2 million, stock compensation costs of $0.2 million, and consulting costs of $0.1 million. Included in our clinical expenses are costs associated with providing manufacturing services to Healios, which are invoiced to Healios in accordance with our collaboration agreements.
General and administrative expenses increased to $3.0 million for the three months ended September 30, 2019 from $2.6 million in the comparable period in 2018. The $0.4 million increase was due primarily to increased legal and professional fees, outside services and stock compensation costs compared to the same period last year.
Net loss for the third quarter of 2019 was $12.0 million compared to a net loss of $9.7 million in the third quarter of 2018. The difference reflects the above variances, as well as an increase in other income.
During the nine months ended September 30, 2019, net cash used in operating activities was $25.2 million compared to $8.8 million in the nine months ended September 30, 2018, with 2018 being impacted by proceeds from the Healios collaboration expansion. At September 30, 2019, we had $40.4 million in cash and cash equivalents, compared to $51.1 million at December 31, 2018.

Conference Call
Gil Van Bokkelen, Chairman and Chief Executive Officer, Laura Campbell, Senior Vice President of Finance, and Karen Hunady, Director of Corporate Communications and Investor Relations will host a conference call today to review the results as follows:
Date

November 6, 2019
Time

4:30 p.m. (Eastern Time)
Telephone access: U.S. and Canada

(877) 396-3286
Telephone access: International

(647) 689-5528
Access code

4183148
Live webcast

www.athersys.com, under the Investors/Events section

We encourage shareholders to listen using the webcast link and to use the phone line if you intend to ask a question. A replay will be available on the webcast at www.athersys.com under the Investors section approximately two hours after the call has ended. Shareholders may also call in for on-demand listening shortly after the completion of the call until 11:59 PM Eastern Time on November 13, 2019 by dialing (800) 585-8367 or (416) 621-4642 and entering Encore passcode 4183148.

On November 6, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data for its approved and investigational medicines across a range of blood diseases will be presented at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from 7 – 10 December 2019, in Orlando, Florida, US (Press release, Hoffmann-La Roche, NOV 6, 2019, View Source [SID1234550459]). Ten Roche medicines will be featured in more than 70 abstracts and 21 oral presentations. These data feature results in 15 blood diseases across numerous molecular targets and combinations, as well as different clinical endpoints that Roche is exploring.

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"We are proud to present a broad range of data at ASH (Free ASH Whitepaper) this year, and of the progress and commitment these data represent," said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. "We believe that our science-driven approach to therapeutic development will continue to provide new options for people with aggressive blood cancers and rare blood diseases."

Key data presentations in non-Hodgkin lymphoma (NHL)
Roche will present data for two CD20-CD3 T-cell engaging bispecific antibodies in NHL (mosunetuzumab and CD20-TCB), including a Plenary Session discussing the phase I/Ib GO29781 study results of mosunetuzumab in people with poor prognosis NHL, which includes those who have had prior chimeric antigen receptor T-cell therapy. The Plenary Session highlights the top six abstracts submitted to the meeting, as determined by the ASH (Free ASH Whitepaper) Program Committee. Additionally, Roche will present new preliminary data evaluating CD20-TCB in combination with other Roche medicines.

Follow-up data on the pivotal phase Ib/II GO29365 study, investigating Polivy (polatuzumab vedotin), a first-in-class antibody drug conjugate, in combination with MabThera/Rituxan (rituximab) and bendamustine in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) will also be presented. This study was the basis of Polivy’s accelerated approval by the US Food and Drug Administration in June 2019 for people with R/R DLBCL who have received at least two prior therapies, and has been submitted to other health authorities around the world for approval consideration.

Key data presentations in chronic lymphocytic leukaemia (CLL), acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS)
Additionally, Roche will be sharing results from three studies of Venclexta/Venclyxto (venetoclax) representing chemotherapy-free treatment options for certain people with leukaemia. Further long-term follow-up data from the pivotal phase III MURANO study in CLL will be presented, as well as an updated analysis from the pivotal phase III CLL14 study with progression-free survival as the primary endpoint and minimal residual disease as a secondary endpoint, confirming the potential of Venclexta/Venclyxto as a fixed-duration treatment option. Results of the investigational medicine idasanutlin, an oral MDM2 inhibitor, in combination with Venclexta/Venclyxto in elderly patients with R/R AML will be shared. Additionally, new data will be presented for Venclexta/Venclyxto as a first-line treatment in MDS, a rare form of blood cancer that affects the bone marrow. Venclexta/Venclyxto is being developed by AbbVie and Roche.

Key data presentations in rare non-malignant blood conditions
Finally, data for rare blood conditions, including haemophilia A and paroxysmal nocturnal haemoglobinuria (PNH) will be presented. New analyses from the phase III HAVEN 3 study of Hemlibra (emicizumab) in people with haemophilia A without factor VIII inhibitors will be presented. The analyses include data on the positive effect of Hemlibra on joint health, as well as additional data on the use of on-demand factor VIII replacement therapy to treat breakthrough bleeding in people receiving Hemlibra prophylaxis in the HAVEN 3 study compared to factor VIII prophylaxis in a non-interventional study. Roche is also sharing phase I/II data from the COMPOSER study, which assessed the investigational medicine crovalimab in people with PNH, a life-threatening disease where red blood cells are destroyed by the body’s immune system. Crovalimab, a novel humanised anti-C5 monoclonal antibody designed to block the complement system, which plays a key role in PNH, was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed by Roche.

Key abstracts featuring Roche medicines that will be presented at ASH (Free ASH Whitepaper) can be found in the table below.

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Polivy (polatuzumab vedotin), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes idasanutlin, a small molecule which inhibits the interaction of MDM2 with p53; T-cell engaging bispecific antibodies targeting both CD20 and CD3; Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

On November 6, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that an abstract related to the Company’s lead drug candidate, tipifarnib, has been accepted for oral presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held from December 7-10, 2019 in Orlando (Press release, Kura Oncology, NOV 6, 2019, View Source [SID1234550476]). The following abstract was published today and is now available on the ASH (Free ASH Whitepaper) website at www.hematology.org.

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Proof of Concept for Tipifarnib in Relapsed or Refractory Angioimmunoblastic T-Cell Lymphoma (AITL) and CXCL12+ Peripheral T-Cell Lymphoma (PTCL): Preliminary Results from an Open-Label, Phase 2 Study (Abstract # 468)
Session Name: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Novel Therapies in Peripheral T-cell Lymphomas
Session Date: Sunday, December 8, 2019
Session Time: 12:00 p.m. – 1:30 p.m. ET
Presentation Time: 1:15 pm ET
Room: Orange County Convention Center, Valencia D (W415D)

A copy of the presentation will be available on Kura’s website at www.kuraoncology.com following presentation at the meeting.

On November 6, 2019 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the use in medically supervised settings, reported that management will be presenting at the Credit Suisse 28th Annual Healthcare Conference to be held November 11 – 13 (Press release, AcelRx Pharmaceuticals, NOV 6, 2019, View Source [SID1234550499]). AcelRx management will provide an overview of the business and company updates during the live presentation and will be available for one-on-one meetings with investors.

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Details of the event are as follows:

Credit Suisse 28th Annual Healthcare Conference
Date: Wednesday, November 13, 2019
Location: The Phoenician, Scottsdale, AZ
Presentation Time: 9:10 am local time (11:10 a.m. ET)

The conference will be webcast live and can be accessed through the Investors page at www.acelrx.com. For those not available to listen to the live broadcast, a replay will be archived for 90 days and available through the Investors page on www.acelrx.com.

On November 6, 2019 BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, reported net revenue of $8.6 million for the third quarter ended September 30, 2019 (Press release, Biolase Technology, NOV 6, 2019, View Source [SID1234550518]).

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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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Third Quarter and Recent Operating and Financial Highlights

The Company’s Inaugural Advancing Dentistry Symposium attracted over 250 professionals in the dental field, providing an opportunity for collaboration and immersive education around technologies and techniques that are advancing dentistry
During the symposium, a first-of-its-kind landmark study by the McGuire Institute on the clinical efficacy of Waterlase-assisted treatment of periodontitis versus open-flap gum surgery was previewed
Waterlase dental lasers received clearance in the U.S. and Canada for crown and veneer removal
Increased financial flexibility and working capital with new credit facility and bolstered balance sheet with $8.5 million equity offering
"Despite being a transition year for BIOLASE as we migrate from an R&D centric company to a full-scale commercial operation, we are progressing as expected, and I am pleased with the team’s overall performance," commented Todd Norbe, President and Chief Executive Officer. "We recently achieved a significant regulatory milestone in the U.S. and Canada as our Waterlase dental lasers received clearance for crown and veneer removal, and we successfully hosted our inaugural two-day Advancing Dentistry symposium with over 250 dental professionals in attendance. At the event, Dr. Donald Clem previewed a first-of-its-kind landmark study by the McGuire Institute on the clinical efficacy of Waterlase-assisted treatment of periodontitis versus traditional open-flap gum surgery. We expect the six-month interim data will be published by the end of 2019 and anticipate the full study data will be published in a scientific journal during the first half of 2020. I continue to believe we have developed the best product to advance dentistry and believe this data will be a positive catalyst for our business. Our focus now is on expanding the reach of this great technology."

2019 Third Quarter Financial Results

Net revenue for the third quarter of 2019 was $8.6 million, in-line with the Company’s previously disclosed revenue estimate, compared to net revenue of $10.9 million for the third quarter of 2018. U.S. laser revenue was $2.3 million for the third quarter of 2019 compared to U.S. laser revenue of $3.8 million for the third quarter of 2018, due to the U.S. sales force realignment announced last quarter. U.S. consumables and other revenue for the third quarter of 2019, which consists of revenue from consumable products such as disposable tips, decreased 5.8% compared to the third quarter of 2018. Outside the U.S., laser revenue declined to $2.8 million for the third quarter of 2019 compared to $3.3 million for the third quarter of 2018, primarily due to generating an order backlog from international distributors as we continue to seek more favorable pricing and payment terms.

Gross margin for the third quarter of 2019 was 34% compared to 36% for the third quarter of 2018. The lower gross margin reflects the impact of fixed costs on lower net revenues, partially offset by operating cost efficiencies. Total operating expenses were $7.9 million for the third quarter of 2019 compared to $8.5 million for the third quarter of 2018, a decrease of $0.6 million despite an increase in provision for bad debt relating to our former distributor in China. Operating loss for the third quarter of 2019, was $4.9 million, compared to an operating loss of $4.5 million for the third quarter of 2018, a decrease of $0.4 million year over year. As previously announced, the net loss for the third quarter of 2019 was $5.5 million, or $0.25 per share compared to a net loss of $4.7 million, or $0.23 per share for the third quarter of 2018.

The Reconciliation of GAAP Net Loss to Adjusted EBITDA at the end of this news release provides the details of the Company’s non-GAAP disclosures and the reconciliation of GAAP net loss and net loss per share to the Company’s Adjusted EBITDA and Adjusted EBITDA per share.

The Adjusted EBITDA for the third quarter of 2019 was $2.7 million, or $0.12 per share compared with Adjusted EBITDA of $3.7 million, or $0.18 per share for the third quarter of 2018.

Cash, cash equivalents, and restricted cash totaled $2.4 million as of September 30, 2019.

Subsequent to the end of the third quarter, on October 29, 2019, the Company completed an $8.5 million public offering of common stock and a private placement of convertible preferred stock, strengthening its balance sheet. On October 31, 2019, the Company secured a $3.0 million revolving line of credit from Pacific Mercantile Bank, the wholly-owned subsidiary of Pacific Mercantile Bancorp, increasing the Company’s financial flexibility and for working capital purposes.

"The new line of credit and recently completed equity offering are significant developments for BIOLASE as they significantly improve our working capital, strengthen our balance sheet and allow us to enter 2020 in a far stronger position," added John Beaver, Executive Vice President and Chief Financial Officer. "We now have the financial flexibility and resources to execute our business plan to return to sustainable, profitable revenue growth and we remain committed to achieving adjusted EBITDA break-even in the current fourth quarter."

Conference Call Information

BIOLASE, Inc. will host a conference call today at 4:30 p.m. Eastern Time to discuss its operating results for the third quarter ended September 30, 2019, and to answer questions. For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 800-458-4148. For international participants outside the U.S./Canada, the dial-in number is 323-794-2093. For all callers, refer to the Conference ID 9068935. To access the live webcast, visit the Investor Relations section of the BIOLASE website at www.biolase.com and see "Investor Events".

An audio archive of the webcast will be available for 30 days on the Investor Relations section of the BIOLASE website.