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BIOLASE Announces Select Preliminary Third Quarter 2019 Financial Results And Date For Reporting Third Quarter 2019 Results

On October 21, 2019 BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, reported select unaudited preliminary financial results for the third quarter ended September 30, 2019 (Press release, Biolase Technology, OCT 21, 2019, View Source [SID1234542390]).

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Select Preliminary Third Quarter 2019 Unaudited Financial Results:

Revenue is expected to be in the range of $8.5 million to $8.8 million.
Loss from operations is expected to be in the range of ($4.8) million to ($5.2) million as the Company increased its allowance for doubtful accounts by approximately $1.1 million to fully reserve for payments still owed to it by its Chinese distributor.
Net loss is expected to be in the range of ($5.4) million to ($5.8) million.
Third quarter adjusted EBITDA is anticipated to be in the range of ($2.7) million to ($3.1) million. The Company continues to expect to be adjusted EBITDA break-even in the fourth quarter of 2019, which is historically the Company’s strongest quarter.
Estimates of financial results are inherently uncertain and subject to change, and actual results may differ materially due to the completion of management’s final review, final adjustments and other developments that may arise before the Company’s financial results for the quarter ended September 30, 2019 are finalized.

Non-GAAP Disclosure

In addition to the financial information prepared in conformity with generally accepted accounting principles in the U.S. ("GAAP"), this press release includes certain historical non-GAAP financial information. Management believes that these non-GAAP financial measures assist investors in making comparisons of period-to-period operating results and that, in some respects, these non-GAAP financial measures are more indicative of the Company’s ongoing core operating performance than their GAAP equivalents.

Adjusted EBITDA is defined as net loss before interest, taxes, depreciation and amortization, stock-based compensation and allowance for doubtful accounts. Management uses adjusted EBITDA in its evaluation of the Company’s core results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. Further, the non-GAAP financial measures presented by the Company may be different from similarly named non-GAAP financial measures used by other companies.

The Company’s outlook for fourth quarter of 2019 earnings is provided on a non-GAAP basis because certain reconciling items are dependent on future events that either cannot be controlled, such as interest rates, or reliably predicted, such as stock-based compensation. Any such reconciling items may be significant.

Conference Call Information
BIOLASE, Inc. will host a conference call on November 6, 2019 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss its financial 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.

Odonate Therapeutics Announces Completion of Enrollment in CONTESSA, a Phase 3 Study of Tesetaxel in Patients with Metastatic Breast Cancer

On October 21, 2019 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported the completion of enrollment in CONTESSA, a multinational, multicenter, randomized, Phase 3 study investigating tesetaxel as a potential treatment for patients with HER2 negative, hormone receptor positive metastatic breast cancer (Press release, Odonate Therapeutics, OCT 21, 2019, View Source;a-phase-3-study-of-tesetaxel-in-patients-with-metastatic-breast-cancer-4b01a676-a578-4c38-a3a8-f70cc4daa7aa [SID1234542388]). The Company expects to report top-line results from CONTESSA in the third quarter of 2020.

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

TRACON Pharmaceuticals Announces $15 Million Common Stock Purchase Agreement With Aspire Capital Fund, LLC

On October 21, 2019 TRACON Pharmaceuticals (Nasdaq:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration through our license to Santen Pharmaceutical Co. Ltd., and utilizing our product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that it has entered into a Common Stock Purchase Agreement of up to $15.0 million with Aspire Capital Fund, LLC ("Aspire Capital") (Press release, Tracon Pharmaceuticals, OCT 21, 2019, View Source [SID1234542387]). Aspire Capital has committed to purchase up to $15.0 million of shares of the Company’s common stock at TRACON’s request from time to time during a 30 month period beginning on the effective date of a registration statement related to the transaction and at prices based on the market price at the time of each sale. There are no warrants, derivatives, or other share classes associated with this agreement. Proceeds from the Agreement will be used to further advance the Company’s pipeline and product development platform, as well as general corporate purposes.

"We are pleased to enter into another transaction with Aspire Capital and believe that this agreement provides TRACON with the opportunity to access capital in an efficient manner," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "The financial flexibility provided by this transaction will further support our business development efforts as we continue to identify opportunities to leverage our product development platform through potential new partnerships with ex-U.S. companies that could benefit from our rapid and capital-efficient U.S. drug development and commercialization solution."

"We are very pleased to be expanding our investment in TRACON and to be continuing our long-term relationship with such an experienced and capable development team. Given the number of significant milestones anticipated in 2020 including data from ongoing clinical trials with DE-122, TRC253, and TJ004309, we firmly believe TRACON has the potential for considerable near-term value creation. Furthermore, TRACON has assembled and refined a highly efficient development platform which has already attracted a number of inimitable and potentially lucrative partnerships including those with Janssen and I-Mab. In particular, we feel the collaboration with I-Mab, which provides an opportunity to access an underappreciated, potentially best-in-class pipeline of bispecific antibodies, provides a strong foundation for similar, high-value ex-US partnerships in the future. We’re excited to see what’s next for TRACON and as a result, are thrilled to provide the company with added financial strength and flexibility as they continue their effort towards making meaningful therapeutic advances for patients with cancer and other diseases of high unmet need," said Steven G. Martin, Managing Member of Aspire Capital.

Under the terms of the Common Stock Purchase Agreement, TRACON will control the timing and amount of any further sale of shares of common stock to Aspire Capital. Aspire Capital has no right to require any sales by TRACON but is obligated to make purchases according to TRACON’s direction. There are no limitations on the use of proceeds, financial covenants or restrictions on future financings and there are no rights of first refusal, participation rights, penalties or liquidated damages in the purchase agreement. TRACON maintains the right to terminate the purchase agreement at any time, at its discretion, without any additional cost or penalty.

As consideration for Aspire Capital’s obligations under the Agreement, TRACON also issued 1,426,579 shares of common stock to Aspire Capital as a commitment fee. TRACON also entered into a Registration Rights Agreement with Aspire Capital in connection with its entry into the purchase agreement that requires TRACON to file a registration statement regarding the shares sold to Aspire Capital. Additional detail regarding the Common Stock Purchase Agreement and related Registration Rights Agreement is set forth in TRACON’s Current Report on Form 8-K, filed today with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Propanc Biopharma Illustrates Novel Mode of Action of PRP, Suppressing EMT Pathways and Metastasis in Cancer Patients

On October 21, 2019 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that the mode of action of the company’s lead product candidate, PRP, a formulation consisting of two proenzymes, has been elucidated by the company’s researchers, by suppressing pathways relating to the Epithelial to Mesenchymal Transition (EMT) and metastasis (Press release, Propanc, OCT 21, 2019, View Source [SID1234542386]). The EMT is a biological process by which cells become motile and invasive, but in cancer stem cells (CSCs), results in metastasis, a process whereby secondary tumors are formed often in remote distances from a primary tumor, causing the cancer to return and spread. Scientific data relating to these key findings were published in Scientific Reports, an online open access journal from the Publishers of Nature, entitled, "Pancreatic Proenzymes treatment suppresses BXPC-3 pancreatic Cancer Stem Cell subpopulation and impairs tumor engrafting."

"Our findings from our recently published paper confirms the mechanism of action of PRP, which may prove to be effective tool in the fight against metastatic cancer, the main cause of patient death for sufferers," said Dr Julian Kenyon, Propanc’s Chief Scientific Officer. "By targeting CSCs, PRP is targeting the fundamental mechanism by which cancer spreads, especially after exposure to chemo or radiation, because they are non-dividing cells and are therefore resistant to standard treatments. The mode of action of PRP is complex due to the biological nature of the proenzymes and its multiple modes of action. By defining how it works, it gives us confidence that this treatment method has potential implications in a clinical setting, for example, by reducing recurrence after drug treatment failures in cancer patients."

CSCs have been characterized as immortal cells that grow inside tumours and have a great tumour-initiating capacity. Disturbingly, CSCs have a capacity to remain dormant that make them radio- and chemo-resistant, whilst highly metastatic. As cancer treatment moves towards more personalised medicine targeting specific genes, proper therapies to target and treat specifically CSCs are needed for reducing recurrence after drug resistance failures.

Recently, an exhaustive scientific study with the company’s joint researchers proved that PRP dramatically impairs the maintenance of CSCs characteristics, eradicating these malignant cell populations, even under cell culture conditions that support their enrichment and growth.

The recent study addresses, in depth, the effect of PRP on the cellular mechanism characteristic of pancreatic CSCs. The modulation of hundreds of genes after treatment were analysed and proved the high impact that PRP has on the CSCs population. In fact, the treatment inhibited the expression of genes related to CSCs characteristics, which means that PRP was able to change the nature of these malignant cells toward a more differentiated and less dangerous cellular condition.

From a more detailed scientific perspective, PRP treatment regulates up to four pathways related to cancer spread and metastasis, such as TGFβ, Hippo, Wnt and Notch pathways. The cascade of reactions that PRP imposes on tumour cells, implies the disruption of the CSC characteristics, which reverses the malignant EMT process that leads to tumour invasion.

Furthermore, PRP downregulation of TGFβ-1, had implications in tumour engraftment. In vivo experiments using a nude mice model, in which tumours were induced by inoculation of pancreatic CSCs, showed that PRP impaired CSCs subpopulation activation, niche formation and tumour initiation. In others words, PRP treatment seems to have a preventive effect against cancer. CSCs that were inoculated after treatment with PRP did not find a "comfortable surrounding" where to nest, implying the anticancer potential of this novel drug.

"We continue to make significant progress with our scientific understanding and development of our lead product, PRP, as a targeted cancer stem cell therapy. The global metastatic cancer treatment market is predicted to reach nearly $100 Billion over the next 5-year period, and we believe PRP has the potential to impact the way we view and treat cancer, by minimizing the potential for its return and spread in patients. We have recently completed preclinical development and look forward to advancing PRP into clinical trials in the near future," said James Nathanielsz, Propanc’s Chief Executive Officer.

According to a new market intelligence report by BIS Research, titled "Global Metastatic Cancer Treatment Market – Analysis and Forecast, 2018-2025", the global metastatic cancer treatment market was estimated at $54.11 billion in 2017, and anticipated to reach $98.24 billion by 2025.

Alkermes Announces Clinical Collaboration With Fred Hutchinson Cancer Research Center for Novel Immuno-Oncology Drug Candidate ALKS 4230

On October 21, 2019 Alkermes plc (Nasdaq: ALKS) reported that it has entered into a clinical research collaboration with Fred Hutchinson Cancer Research Center (Fred Hutch) for ALKS 4230, Alkermes’ immuno-oncology drug candidate (Press release, Alkermes, OCT 21, 2019, View Source [SID1234542385]). ALKS 4230 is a novel, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex.

The planned phase 2 multi-site trial, ION-01, is designed to estimate the response rate to ALKS 4230 in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced or recurrent head and neck squamous cell cancer who did not achieve complete remission with an anti-PD-(L)1 antibody treatment. Secondary objectives include evaluation of the duration of response, progression-free survival, time to progression and overall survival of patients with advanced or recurrent head and neck squamous cell cancer receiving treatment with ALKS 4230 in combination with pembrolizumab. As an exploratory objective, the ION-01 study will assess the tumor microenvironment using paired tumor biopsies to evaluate potential predictive biomarkers for response to the addition of ALKS 4230. This multi-site study is designed to leverage the scientific, clinical and management resources of the Immune Oncology Network (ION), a network of foremost academic immunologists at top North American universities and cancer centers. The study is expected to initiate in the fourth quarter of 2019.

"We are honored to collaborate with Fred Hutch, given its commitment to improving outcomes and advancing care for people living with cancer," said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. "We’re encouraged by the profile emerging from the preclinical and initial clinical data for ALKS 4230 and are eager to explore whether this novel investigational drug may improve the therapeutic benefit of checkpoint inhibition with pembrolizumab, in patients with head and neck cancers. The ION-01 study, along with our ongoing ARTISTRY clinical development program, offers the opportunity to strengthen and advance our scientific and clinical understanding of ALKS 4230 and its potential role in treating cancer patients with high unmet needs."

About ALKS 4230
ALKS 4230 is a novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase 1/2 study in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. ARTISTRY-1 has three distinct stages: an ongoing monotherapy dose-escalation stage, a recently-initiated monotherapy expansion stage and an ongoing combination therapy stage with the PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with select advanced solid tumors. ARTISTRY-2 is an ongoing phase 1/2 study of ALKS 4230 administered subcutaneously as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. ARTISTRY-2 is designed to explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules.