On August 6, 2020 CANbridge Pharmaceuticals Inc., a biopharmaceutical company developing innovative drug candidates to treat underserved medical conditions, reported that it has received marketing approval from the Taiwan Food and Drug Administration for NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy (Press release, CANbridge Life Sciences, AUG 6, 2020, View Source [SID1234563185]). NERLYNX was approved in Hong Kong in 2019 and in mainland China earlier this year. CANbridge acquired the exclusive NERLYNX development and commercial rights from Puma Biotechnology, Inc. for Greater China in 2018.

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About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

On August 6, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported second quarter 2020 financial results (Press release, Oncternal Therapeutics, AUG 6, 2020, View Source [SID1234563184]).

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"We are extremely pleased by the progress achieved in our development programs and the enthusiasm that we have received from the medical community," said James Breitmeyer, M.D., Ph.D., President and CEO, Oncternal. "We are expecting additional data read-outs in our clinical trials in patients with MCL and Ewing sarcoma in the second half of this year, which we believe could be transformative for our company."

Recent Highlights

In May 2020, a data update from the ongoing Phase 1/2 clinical trial of cirmtuzumab in combination with ibrutinib was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Annual Meeting, showing a 58% complete response (CR) rate and 83% overall best objective response rate (ORR) for patients with relapsed/refractory MCL. The one patient who relapsed following prior CD19 CAR-T therapy achieved a CR on this study. Of the four patients who relapsed following a prior regimen that included ibrutinib, all four responded on this study, with two CRs and two partial responses. The combination of cirmtuzumab plus ibrutinib has been well tolerated, with adverse events consistent with those reported for ibrutinib treatment alone. Cirmtuzumab is an investigational, potentially first-in-class humanized monoclonal antibody that binds with high affinity to a biologically important epitope on ROR1 (Receptor-tyrosine kinase-like Orphan Receptor 1).
In June 2020, based on encouraging data presented at ASCO (Free ASCO Whitepaper) 2020, we announced an increased focus on our cirmtuzumab ROR1 antibody program for patients with MCL. We are amending the ongoing Phase 1/2 study clinical trial of cirmtuzumab with ibrutinib to increase enrollment of patients with MCL in the Phase 2 expansion cohort to at least 20 patients and to allow enrollment of patients with a broader range of prior ibrutinib treatments. We have requested a meeting with the U.S. Food and Drug Administration (FDA) to seek guidance on a potential accelerated approval pathway for cirmtuzumab plus ibrutinib in patients with relapsed/refractory MCL.
In June 2020, we announced that the FDA granted the company orphan drug designations of cirmtuzumab for treatment of MCL and for treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma.
In July 2020, we hosted a virtual scientific presentation on the current treatment landscape of MCL, along with a discussion of the cirmtuzumab MCL clinical dataset, with Dr. Michael Wang, professor of Lymphoma & Myeloma at The University of Texas MD Anderson Cancer Center.
Enrollment has accelerated in the expansion cohort of our ongoing, open-label, multicenter Phase 1 clinical trial of TK216 for patients with relapsed/refractory Ewing sarcoma, despite the COVID-19 pandemic, following our announcement in April 2020 of an interim clinical data update, including deep responses in two patients. We now anticipate announcing clinical data for 12 to 16 patients dosed in this expansion cohort in the fourth quarter of 2020, above our previous guidance of data for 7 to 12 patients. TK216 is an investigational, potentially first-in-class targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins.
In May and July 2020, we announced an aggregate of $11.2 million in gross proceeds from registered direct offerings priced at-the-market under Nasdaq rules.
Expected Upcoming Milestones

TK216 (ETS inhibitor) program
Clinical data for 12 to 16 patients with Ewing sarcoma treated in the Phase 1 expansion cohort to be presented at a scientific conference – in the fourth quarter of 2020
Potential Investigational New Drug Application (IND)-supporting data in additional ETS-driven tumors to be available – in the second half of 2020
Cirmtuzumab (ROR1 antibody) program
Clinical data update for patients with MCL treated with cirmtuzumab plus ibrutinib in the ongoing Phase 1/2 study to be presented at a scientific conference – in the fourth quarter of 2020
Clinical data update for patients with CLL treated with cirmtuzumab plus ibrutinib in the ongoing Phase 1/2 study to be presented at a scientific conference – in the fourth quarter of 2020
Clinical data update for patients with HER2-negative breast cancer in the ongoing Phase 1b study to be presented at a scientific conference – in the first half of 2021
Potential IND-supporting data in additional ROR1 expressing tumors to be available – in the second half of 2020
ROR1 CAR-T program
First-in-human dosing in China – in 2021
Second Quarter 2020 Financial Results

Our grant revenue was $0.6 million for the second quarter ended June 30, 2020. Our grant revenue is derived from a sub-award under a grant from CIRM to UC San Diego, which was awarded to advance our Phase 1/2 clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with MCL or CLL.

Our total operating expenses for the second quarter ended June 30, 2020 were $6.2 million. Research and development expenses for the quarter totaled $3.8 million, and general and administrative expenses for the quarter totaled $2.3 million. Net loss for the second quarter was $5.5 million, or a loss of $0.34 per share, basic and diluted.

As of June 30, 2020, we had $16.6 million in cash and cash equivalents. In addition, on July 21, 2020, we completed a registered direct offering priced at-the-market under Nasdaq rules, with gross proceeds of $6.2 million, before deducting placement agent’s fees and other estimated offering expenses. We believe our current funds will be sufficient to fund our operations into the second quarter of 2021. Following the offering, we had 19.9 million shares of common stock outstanding.

Management Webcast

As previously announced, Oncternal will host a webcast today, August 6, 2020, at 5:00 p.m. ET (2:00 p.m. PT). The live webcast will be available online and may be accessed from the "Investors" page of the company website at View Source A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

On August 6, 2020 Quanterix Corporation (Nasdaq: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported that it has commenced an underwritten public offering of its common stock (Press release, Quanterix, AUG 6, 2020, View Source [SID1234563183]). In connection with the offering, Quanterix intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock at the public offering price less the underwriting discounts and commissions. All of the shares in the offering will be sold by Quanterix. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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SVB Leerink and Cowen are acting as joint bookrunning managers for the offering. Canaccord Genuity is acting as co-manager for the offering.

The public offering will be made pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at View Source The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained, when available, from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at (800) 808-7525, ext. 6218 or by email at [email protected], or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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

On August 6, 2020 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported financial results and business highlights for the third quarter of fiscal 2020, ended June 30, 2020 (Press release, Twist Bioscience, AUG 6, 2020, View Source [SID1234563182]).

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"We posted a strong quarter of revenue growth for both synthetic biology and next generation sequencing (NGS) along with solid orders and a robust pipeline of opportunities across our silicon-based technology platform," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "Our disruptive platform combined with our unique business model continues to enable us to expand our footprint among our existing markets, extend our reach through biopharma partnerships and concurrently respond to pressing market needs including demand for COVID-19 related products."

FISCAL 2020 THIRD QUARTER FINANCIAL RESULTS

Orders: Total orders received for the third quarter of fiscal 2020 were $24.7 million, compared to $18.1 million for the same period of fiscal 2019.
Revenue: Total revenues were $21.2 million for the third quarter of fiscal 2020 compared to $13.6 million for the same period of fiscal 2019.
Cost of Revenues: Cost of revenues for the third quarter of fiscal 2020 was $16.5 million compared to $11.4 million for the same period of fiscal 2019.
Research and Development Expenses: Research and development expenses for the third quarter of fiscal 2020 were $10.4 million compared to $9.0 million for the same period of fiscal 2019.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the third quarter of fiscal 2020 were $22.5 million compared to $21.3 million for the same period of fiscal 2019.
Net Loss: Net loss for the third quarter of fiscal 2020 was $28.2 million, or $0.67 per share, compared to $27.9 million, or $0.92 per share, for the third quarter of fiscal 2019.
Cash Position: As of June 30, 2020, the company had $311.8 million in cash, cash equivalents and short term investments.
"During the fiscal third quarter of 2020, we delivered another quarter of sequential growth and we continued to prove out our platform, tapping into new revenue opportunities," commented Jim Thorburn, CFO of Twist. "We expanded our customer base, booked solid orders and concluded a successful financing, ending the quarter with $311.8 million in cash and short-term investments, well positioned to deliver growth in this challenging environment."

Fiscal Third Quarter 2020 and Recent Highlights

Shipped products to 1,377 customers in the third quarter of fiscal 2020, versus 834 in the same period of fiscal 2019.
Continued to support customers in the fight against COVID-19 including Vanderbilt University Medical Center (VUMC), who published positive preclinical results using potently neutralizing antibodies as a potential therapy to prevent and treat COVID-19.
Expanded infectious disease product line with the addition of:
The Twist Respiratory Virus Research Panel, a robust next-generation sequencing (NGS) approach to detecting a wide range of respiratory diseases including SARS-CoV-2, the virus that causes COVID-19, several other coronaviruses, influenzas, rhinoviruses and respiratory syncytial virus.
Synthetic controls for the environmental testing, assay development, verification, and ongoing validation of diagnostic tests for a broad range of common respiratory diseases including SARS-CoV-2.
Announced a partnership with Takeda Pharmaceutical Company Limited (Takeda) for access to Twist Biopharma’s proprietary phage display libraries for the discovery, validation and optimization of antibodies in Takeda’s pipeline of biologics for oncology, rare diseases, neuroscience and gastroenterology.
Announced an agreement with Invetx, a pioneer in protein-based therapeutics for animal health, for the engineering and optimization of novel antibodies for the treatment of serious diseases in dogs and cats.
Announced a partnership with Seismic Bio for the discovery and optimization of antibodies to high-value immuno-oncology targets.
In fiscal 2020, have signed nine revenue-generating partnership related to Twist Biopharma, a division of Twist Bioscience; six of the partnerships include milestones and/or royalties.
Launched two new SARS-CoV-2 antibody panels: the Twist anti-SARS-CoV-2 S1 Antibody Panel and the Twist Human anti-ACE2 Antibody Panel, to expedite research for COVID-19.
Advanced our DNA data storage technology, setting the stage for commercialization of a platform that we expect will be cost competitive with current commercial data storage methods.
Completed an offering of approximately 3.48 million shares of our common stock at a price of $33.00 per share raising approximately $107.5 million in proceeds, net of estimated offering expenses.
Appointed Erin Smith as senior vice president of government affairs and public policy.
COVID-19 Considerations

During the three months ended June 30, 2020, financial results of the Company were not significantly affected by the COVID-19 outbreak. However, the extent to which the COVID-19 outbreak affects Twist’s future financial results and operations is subject to a high degree of uncertainty and will depend on future developments, including the duration, spread and treatment of the outbreak domestically and abroad.

Conference Call Information

The company plans to hold a conference call and live audio webcast for analysts and investors today at 4:30 p.m. Eastern Time to discuss its financial results and provide an update on the company’s business. The call can be accessed by dialing (866) 688-0947 (domestic) or (409) 217-8781 (international) and refer to the conference ID 4462599. A telephonic replay of the conference call will be available beginning approximately four hours after the call through August 13, 2020 and may be accessed by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international). The replay conference ID is 4462599. The webcast replay will be available for two weeks.

Given the circumstances globally, it is recommended to dial-in at most 15 to 20 minutes prior to the call start to reduce waiting times. If a participant will be listen-only, they are encouraged to listen via the webcast on Twist’s investor page.

On August 6, 2020 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, reported that Cleveland Clinic has joined GRAIL’s PATHFINDER Study, a prospective, multi-center clinical study that is evaluating the implementation of Galleri, an investigational multi-cancer early detection blood test, into clinical practice for the first time (Press release, Grail, AUG 6, 2020, View Source [SID1234563179]).

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Today, the majority of cancers are found too late when outcomes are often fatal, because most deadly cancers have no available screening tests. Current recommended screenings are critical, but they cover only four cancers and screen for a single cancer at a time. In fact, cancers responsible for nearly 71% of cancer deaths have no recommended early detection screening.

"We believe multi-cancer early detection has the potential to address a tremendous unmet need and reduce the cancer burden worldwide," said Joshua Ofman, MD, MSHS, Chief Medical Officer and External Affairs at GRAIL. "We are honored to partner with Cleveland Clinic and our other PATHFINDER Study partners in this endeavor, and are grateful to all the participants across the U.S. who are helping to bring this potentially transformative technology to patients, providers, and communities."

Data from GRAIL’s foundational Circulating Cell-free Genome Atlas (CCGA) Study demonstrated an earlier version of Galleri could detect more than 50 cancers across all stages — over 45 of which don’t have early cancer screening today — with a very low false positive rate of less than 1%, through a single blood draw. The PATHFINDER Study is an important step on the path to commercialization by allowing GRAIL to evaluate how Galleri can effectively be implemented in clinical practice.

Cleveland Clinic joins initial PATHFINDER health system partners that include Dana-Farber Cancer Institute, Intermountain Healthcare, Mayo Clinic, Oregon Health & Science University, and Sutter Health.

The PATHFINDER Study is conducted under an investigational device exemption (IDE) application approved by the Food and Drug Administration (FDA) to evaluate GRAIL’s multi-cancer early detection test. GRAIL believes that its IDE application is the first approved by the FDA for a return-of-results study involving a multi-cancer next-generation sequencing-based blood test.

About the PATHFINDER Study

The PATHFINDER Study is evaluating the implementation of GRAIL’s investigational multi-cancer early detection test in clinical practice, and marks the first time Galleri will be used to return results to people. PATHFINDER will enroll approximately 6,200 participants across several health systems and is sponsored by GRAIL.

GRAIL’s test is not yet available for use outside of this investigational study. It is not meant to replace the cancer screening tests healthcare providers may recommend, such as colonoscopy or mammography. For more information, visit www.grail.com/clinical-studies/pathfinder-study.