Moderna to Report Third Quarter 2019 Financial Results on Wednesday, November 6th, 2019

On October 22, 2019 Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported that it will host a live conference call and webcast at 8:00 a.m. ET on Wednesday, November 6, 2019 to report its third quarter 2019 financial results and provide a corporate update (Press release, Moderna Therapeutics, OCT 22, 2019, View Source [SID1234542416]).

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To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international), and refer to conference ID 6287715. A webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website at View Source The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for 30 days following the call.

Oragenics, Inc. to Present at the BIO Investor Forum

On October 22, 2019 Oragenics, Inc. (NYSE American:OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis (OM), reported it will be presenting at the BIO Investor Forum in San Francisco (Press release, Oragenics, OCT 22, 2019, View Source [SID1234542415]).

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The company will present to investors on October 23, 2019, at 2:30 PM ET in the Yorkshire Room of Westin St. Francis in San Francisco. The BIO Investor Forum will be held October 22-23, 2019.

Further details of the company’s financial filings can be found by accessing the United States Securities and Exchange Commission website at www.sec.gov.

About AG013

AG013, which has been granted Fast Track designation with the U.S. Food and Drug Administration and orphan drug status in Europe, is an ActoBiotics therapeutic candidate formulated to deliver the therapeutic molecule Trefoil Factor 1 to the mucosal tissues in the oral cavity in a convenient oral rinsing solution. Trefoil Factors are a class of peptides involved in the protection of gastrointestinal tissues against mucosal damage and play an important role in subsequent repair. The compound was designed by the company’s strategic partner, ActoBio Therapeutics, Inc., a wholly-owned subsidiary of Intrexon Corporation (NYSE: XON).

About Lantibiotics

Lantibiotics are a class of antibiotic compounds with novel mechanism of action, prized for their ability to overcome antibiotic-resistant infections. With resistant strains on the rise, particularly healthcare-acquired infections (HAI), the need for these potent lantibiotic agents is critical. Oragenics is pursuing the commercial-scale production of a lantibiotic for use as an antimicrobial.

TLC Reports Third Quarter 2019 Financial Results and Provides Business Update

On October 22, 2019 TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need in pain management, ophthalmology and oncology, reported financial results for the third quarter ended September 30, 2019, and provided a business update (Press release, Taiwan Liposome Company, OCT 22, 2019, View Source [SID1234542414]).

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"The third quarter of 2019 showed continued significant progress for TLC, as we kicked off the Phase III clinical trial of TLC599 for osteoarthritis knee pain," said George Yeh, President of TLC. "We are hopeful that results from this pivotal trial will support a New Drug Application (NDA) submission for TLC599 with the US Food and Drug Administration (FDA). We also continue to advance our broad pipeline, with last patient enrollment of the Phase II clinical trial of TLC590 for the treatment of postsurgical pain expected in the first half of 2020. In addition, the timely addition of Dr. Vincent Chang to our team as Vice President of Manufacturing and Development reflects our investment towards ensuring that we have the best quality supply for our clinical trials and are well-positioned to move forward for potential commercial launches."

Clinical Pipeline Update and Upcoming Milestones

Initiation of Phase III pivotal clinical trial of TLC599 osteoarthritis knee. The multi-center, randomized, double-blind, placebo- and active comparator-controlled study, "EXCELLENCE", will treat about 500 patients at 40-50 sites in the United States and Australia to evaluate the safety and efficacy of single and repeated doses of TLC599 for up to 52 weeks.

Potential cartilage-protecting effects of TLC599 will be presented in a poster at 2019 ACR/ARP Annual Meeting in Atlanta, GA, on November 12, 2019. Magnetic resonance imaging (MRI) evaluation suggests slowing of cartilage damage and potential chondroprotection in osteoarthritis of the knee.

E-poster presentation at ANESTHESIOLOGY 2019 showed TLC590 for the management of postsurgical pain to yield more immediate and longer lasting pain relief than ropivacaine in hernia repair surgery. A publication in the International Journal of Nanomedicine details the ten-fold half-life of TLC590 and its prolonged analgesic effect compared to ropivacaine in preclinical studies. A Phase II, randomized, double-blind, comparator- and placebo-controlled clinical trial to evaluate the safety, pharmacokinetics and efficacy of TLC590 following bunionectomy is ongoing; enrollment of the last patient is expected to take place in the first half of 2020.

Poster presentation at ESMO (Free ESMO Whitepaper) 2019 demonstrated the potential of TLC178 (liposomal vinorelbine) to treat sarcomas with decreased dosing frequency and reduced toxicity. In preclinical studies, TLC178 exhibited more anti-tumor activity than a) doxorubicin in the soft tissue sarcoma model and b) both non-liposomal vinorelbine (VNB) and VNB + cyclophosphamide in the rhabdomyosarcoma model, and showed an improved pharmacokinetic profile and five-fold accumulation at the tumor site compared to VNB. An ongoing Phase I/II dose escalation clinical trial in adults has recruited 33 patients thus far. 
Corporate Highlights

Appointment of new Vice President of Manufacturing Development. Vincent Chang, PhD, has a deep experience in process development, project management and quality assurance attained from over 35 years at Abbott, Roche, GlaxoSmithKline and Bayer. Dr. Chang will guide the Company in affairs related to the chemistry, manufacturing and controls of its product candidates.

Provided updates at Baird Global Healthcare Conference and Janney Healthcare Conference; discussed TLC’s pain programs at BTIG Pain Management Forumamong a panel of experts and key opinion leaders as to the potential benefits of TLC599 and TLC590 as non-opioid treatments for pain.

Expanded global intellectual property protection to 140 patents, with 63 patents granted and 77 applications worldwide as of September 30, 2019.
Third Quarter 2019 Financial Results

Operating revenue for the third quarter of fiscal 2019 was NT$18.8 million (US$0.6 million), a 23.3% increase compared to NT$15.3 million (US$0.5 million) in the third quarter of fiscal 2018. Operating expenses for the third quarter of fiscal 2019 was NT$198.1 million (US$6.4 million), a 9.5% decrease compared to NT$218.9 million (US$7.2 million) in the third quarter of fiscal 2018. Net loss for the third quarter of fiscal 2019 was NT$178.4 million (US$5.7 million), compared to a loss of NT$196.0 million (US$6.4 million) in the third quarter of 2018, or a net loss of NT$2.80(US$0.09) per share for the third quarter of fiscal 2019, compared to a net loss of NT$3.52(US$0.12) per share for the third quarter of fiscal 2018.

The Company’s cash and cash equivalents and time deposits with maturity over three months (which are classified as "current financial assets at amortized cost" in the Company’s consolidated financial statements) were NT$1,007.5 million (US$32.5 million) as of September 30, 2019, compared to NT$1,114.6 million (US$36.4 million) as of December 31, 2018.

Veracyte Announces Third Quarter 2019 Financial Results and Business Progress

On October 22, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported financial results and business progress for the third quarter ended September 30, 2019. For the third quarter of 2019, revenue was $31.0 million, an increase of 32% over the third quarter of 2018 (Press release, Veracyte, OCT 22, 2019, View Source [SID1234542412]). Net cash used in operating activities in the third quarter of 2019 was $1.6 million, an improvement of 13% compared with the third quarter of 2018.

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"We had a solid third quarter in which we continued to drive volume and revenue growth across our products and grew biopharmaceutical services revenue through key milestone achievements," said Bonnie H. Anderson, chairman and chief executive officer of Veracyte. "We are particularly excited by the new, preliminary data for our noninvasive nasal swab test for early lung cancer detection, which we believe has significant potential to improve care among the millions of patients with suspicious lung nodules detected each year. Importantly, as we grow our business and advance our pipeline, we remain on track to achieve our goal of reaching cashflow breakeven status before the end of the year."

Third Quarter 2019 Financial Results

For the third quarter of 2019 as compared with the third quarter of 2018:

Revenue was $31.0 million, an increase of 32%; excluding $4.3 million of biopharmaceutical services revenue, revenue was $26.7 million, an increase of 15%.
Gross Margin was 71%, an increase of six percentage points; excluding biopharmaceutical services revenue, gross margin was 66%, an increase of two percentage points.
Operating Expenses, Excluding Cost of Revenue were $23.6 million, an increase of 21%.
Net Loss was $0.7 million, an improvement of 84%.
Net Loss Per Share was $0.02, an improvement of 83%.
Net Cash Used in Operating Activities was $1.6 million, an improvement of 13%.
Cash and Cash Equivalents were $195.7 million at September 30, 2019.
For the nine-month period ended September 30, 2019, as compared with the prior year period of 2018:

Revenue was $90.6 million, an increase of 37%; excluding $11.8 million of biopharmaceutical services revenue, revenue was $78.8 million, an increase of 20%.
Gross Margin was 71%, an increase of eight percentage points; excluding biopharmaceutical services revenue, gross margin was 66%, an increase of three percentage points.
Operating Expenses, Excluding Cost of Revenue were $71.2 million, an increase of 17%.
Net Loss was $5.1 million, an improvement of 74%.
Net Loss Per Share was $0.11, an improvement of 80%.
Net Cash Used in Operating Activities was $5.0 million, an improvement of 59%.
Third Quarter 2019 and Recent Business Highlights

Commercial Growth and Reimbursement Expansion:

Grew total genomic test volume in the third quarter of 2019 to 9,941, an increase of 24% over the third quarter of 2018.
– Increased Percepta Genomic Sequencing Classifier (GSC) volume to 793 tests, an increase of 112% compared to the third quarter of 2018.

– Expanded Envisia Genomic Classifier volume to 223 tests, a Q3 2019 growth sequentially over Q2 2019 of 72%.

– Grew Afirma test volume to 8,925 tests, an increase of 17%, compared to the third quarter of last year.

Strengthened Library of Clinical Evidence:

Published a clinical and analytical validation paper in Frontiers in Endocrinology demonstrating the Afirma Xpression Atlas’s ability to help inform surgery and treatment decisions in patients with thyroid nodules deemed suspicious for cancer by the Afirma Genomic Sequencing Classifier. A separate paper published in Thyroid reinforced the test’s potential value in clinical practice.
Five studies are being presented at the annual meeting of the American College of Chest Physicians (CHEST 2019), including:
– Three abstracts showing that the Envisia classifier enhances physicians’ ability to confidently distinguish idiopathic pulmonary fibrosis from other interstitial lung diseases when used with high-resolution CT imaging.

– Two abstracts demonstrating the clinical validity and utility, respectively, of the Percepta classifier in lung cancer diagnosis when bronchoscopy findings are inconclusive.

Advanced Pipeline:

Presented data at CHEST 2019 demonstrating the ability of the company’s preliminary nasal swab test to enable early lung cancer detection and diagnosis. The findings show that the test can accurately classify lung cancer risk in patients with lung nodules so that they may be directed to prompt diagnosis and treatment or may be monitored noninvasively.
Updated 2019 Financial Outlook

Veracyte is re-affirming its 2019 annual revenue guidance of $119 million to $122 million and net cash used in operating activities of $2 million to $4 million.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast to discuss its financial results and provide a general business update at 5:00 p.m. Eastern time today.

The conference call will be webcast live from the company’s website and will be available via the following link: View Source webcast should be accessed 10 minutes prior to the conference call start time.

A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call can be accessed as follows:

U.S./Canada participant dial-in number (toll-free):

(855) 541-0980

International participant dial-in number:

(970) 315-0440

Conference I.D.:

8767084

TRILLIUM THERAPEUTICS ANNOUNCES CORPORATE RESTRUCTURING AND PROVIDES CD47 PROGRAM UPDATE

On October 22, 2019 Trillium Therapeutics Inc. (Trillium, ‘the company") (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported corporate restructuring to extend the company’s cash runway and to focus on critical value-creating activities (Press release, Trillium Therapeutics, OCT 22, 2019, View Source [SID1234542411]). The company also provided an update on its clinical development and research programs.

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"Since assuming the CEO role a month ago, my immediate focus has been on conducting an in-depth review of our strategic priorities and ongoing programs, as well as our available resources", said Jan Skvarka, President and Chief Executive Officer of the company. "Building on our strong scientific foundation, the goal of this restructuring is to create a leaner, more clinical development-centric organization and extend our cash runway. The near-term focus will be on the clinical development of intravenously administered TTI-621, our anti-CD47 product candidate that has shown promising preliminary evidence of activity in a number of hematologic malignancies. Unfortunately the restructuring will impact many highly talented and dedicated employees. Trillium would not exist without their contributions, for which we will always be deeply grateful."

Corporate Restructuring

Under the restructuring program, staff will be reduced by 40%, from 43 to 26 active employees, with immediate effect. The company will discontinue its discovery research activities to focus on clinical development and seek a partner for further development of its preclinical STING agonist program. Further cost savings will be achieved through operational efficiencies.

These savings are expected to reduce cash outlay from approximately CDN$10 million per quarter in the first half of 2019 to approximately CDN$4-7 million per quarter in 2020. The company currently expects to have cash and cash equivalents of approximately CDN$36 million at the end of the third quarter of 2019.

CD47 Program Update

The ongoing dose escalation trial of intravenously administered TTI-621 is on track and remains the key strategic priority going forward. The 0.7 mg/kg dose cohort in this study has been completed and no dose-limiting toxicities have been identified. Enrollment in the 1.0 mg/kg cohort is beginning. The goal of this trial is to identify a recommended phase 2 dose to enable additional studies in both cutaneous T-cell lymphoma (CTCL) and other hematologic malignancy indications with high unmet medical need.

In September, the company met with the U.S. Food and Drug Administration (FDA) which provided guidance on the intratumoral use of TTI-621 for the treatment of early-stage CTCL, including aspects of a potential registration study. The company is evaluating this guidance and considering options going forward, given current resource constraints. The ongoing phase 1b intratumoral trial, which provided the data set for the FDA interaction and informed the guidance, will now be closed.