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.

On August 6, 2020 Maverick Therapeutics, Inc., a private biopharmaceutical company pioneering conditionally active bispecific T cell targeted immunotherapies, reported the publication of a peer-reviewed article in mAbs, a leading journal focused on the science of antibody research and development. The article, titled "COBRA: a highly potent conditionally active T cell engager engineered for the treatment of solid tumors," establishes Maverick’s core platform in the context of the current T cell engager landscape as applied to solid tumors, and highlights Maverick’s technological advances in developing the next generation of conditionally active T cell engaging therapies for solid tumors. The article was published online in mAbs, Volume 12 Issue 1 and can be accessed at View Source

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"The publication marks an exciting achievement for our company as the first peer-reviewed article that substantiates the innovative science behind our COBRA platform and what sets it apart from other bispecific T cell engaging therapies," said Jim Scibetta, Chief Executive Officer, Maverick Therapeutics. "This new mechanism of action elegantly safeguards healthy tissue and creates a wide therapeutic window to more thoroughly eradicate tumors. It also establishes for Maverick a robust platform for fulfilling unmet needs in the treatment of solid tumors and advances our company’s vision to develop the next generation of safe and efficacious treatments to address a broad number of solid tumor cancers."

The COBRA therapeutic platform takes advantage of the tumor’s highly proteolytic microenvironment for T cell activation, allowing it to safely target solid tumors with highly specific and potent activity. The publication describes the current limitations of inherently active first-generation T cell engagers as applied to solid tumors and Maverick’s unique approach in bispecific antibody design to develop a solution.

"We are encouraged by the interest and quick-turn of this publication, which lays out the on-target off-tumor toxicity problem with current T cell engagers for the treatment of solid tumors and describes the rationale for creating protease-activated prodrugs as a solution," said Robert DuBridge, Ph.D., EVP, Research and Chief Technology Officer, Maverick Therapeutics. "I, along with the team at Maverick, look forward to further validating our novel COBRA platform as we prepare for upcoming clinical activity in 2021."

Maverick’s first-in-class COBRA programs, MVC-101 and MVC-280, have generated promising preclinical data designed to validate the COBRA mechanism of action and be predictive of translation to patients. Preclinical models for MVC-101 and MVC-280 indicate that these conditionally active molecules have a therapeutic index that is up to 100 times greater than that of an inherently active first-generation T cell engager. Maverick expects to initiate a Phase 1 trial of MVC-101 in Q1 2021 and MVC-280 in H2 2021.

About the COBRA Platform
Maverick Therapeutics’ COBRA platform is the most mature conditionally active bispecific T cell engaging platform designed to safely target a broad range of solid tumors with highly specific and potent activity while limiting on-target toxicities in normal tissues. By nature of its highly innovative design, the COBRA platform reflects a novel approach to T cell engaging immunotherapies where T cell activation and resulting cell killing only take place where it is needed – in tumors. This unique design delivers the long sought trifecta in cancer care; high specificity, high potency and reduced toxicity.

About MVC-101
Maverick Therapeutics’ lead program candidate, MVC-101, is a proprietary COBRA molecule designed to target the Epidermal Growth Factor Receptor (EGFR), a protein expressed on both malignant and healthy tissues. MVC-101 regressed established human tumors in several preclinical models. Exposures of MVC-101 at efficacious relative to tolerated doses in safety studies demonstrates an increased therapeutic index compared to standard T cell engagers. MVC-101 is designed to be a universal solution for patients with EGFR expressing solid tumor cancers. EGFR is expressed on a wide range of solid tumor cancers, including but not limited to colorectal, head & neck, renal, pancreatic, cervical and non small cell lung cancers. Maverick expects to initiate a Phase 1 trial in Q1 2021.

About MVC-280
Maverick Therapeutics’ second program candidate, MVC-280, is a proprietary COBRA molecule designed to target B7H3 (CD276). B7H3 is expressed in a broad range of malignant and healthy tissues, similar to EGFR. MVC-280 regressed established tumors in several preclinical models. It is cross-reactive to its target protein expressed on mouse tissues, creating an opportunity to measure both efficacy and relative safety in the same preclinical model and use that data to calculate a therapeutic index. MVC-280 is designed to be a universal solution for patients with B7H3 expressing solid tumor cancers. B7H3 is expressed on a wide range of solid tumor cancers, including but not limited to prostate, renal, triple negative breast, head & neck, ovarian and urothelial cancers. Maverick expects to initiate a Phase 1 trial in H2 2021.

On August 6, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended June 30, 2020 and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, AUG 6, 2020, View Source [SID1234563176]).

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"Despite the unforeseen challenges of recent months, our team at Syros has shown remarkable resiliency, continuing to execute with excellence as we advance our product candidates toward key data readouts and progress earlier-stage research," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We completed enrollment in our Phase 2 trial of SY-1425, opened a new combination cohort in treatment-resistant breast cancer patients in our Phase 1 trial of SY-5609, and presented new preclinical data on SY-5609 in colorectal cancer that further highlights CDK7 inhibition as a potentially transformative targeted approach for difficult-to-treat cancers.

Looking ahead, the second half of 2020 promises to be an exciting time for Syros, with planned data readouts for SY-1425 in two RARA-positive AML patient populations and the first clinical data from the Phase 1 trial of SY-5609 in select solid tumor patients. These data will provide valuable insights that will help inform next steps and, hopefully, bring us closer to our vision of building an enduring company with medicines that provide a profound benefit for patients."

Upcoming Milestones

SY-1425

Report potential proof-of-concept data in the fourth quarter of 2020 from the ongoing, fully enrolled Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory acute myeloid leukemia (AML) patients.
Report mature data in the fourth quarter of 2020 from the ongoing, fully-enrolled Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy.
SY-5609

Report initial safety, tolerability, pharmacokinetic and pharmacodynamic data in the fourth quarter of 2020 from the ongoing Phase 1 dose-escalation trial evaluating SY-5609 in patients with breast, colorectal, lung and ovarian cancers, as well as in patients with solid tumors of any histology that harbor Rb pathway alterations.
Report additional dose-escalation data, including clinical activity data, in mid-2021.
Preclinical Pipeline

Nominate next development candidate by the end of 2021.
Recent Pipeline Highlights

In June 2020, Syros initiated enrollment in a new Phase 1 trial cohort evaluating the safety of escalating doses of SY-5609 in combination with fulvestrant in HR-positive metastatic breast cancer patients who have progressed after treatment with a CDK4/6 inhibitor.
In May 2020, Syros presented new preclinical data for SY-5609 at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program (ASCO20). Data showed that SY-5609 inhibits tumor growth, including inducing sustained regressions, at well-tolerated doses in colorectal cancer models, supporting the inclusion of colorectal cancer patients in Syros’ ongoing Phase 1 trial. Also at ASCO (Free ASCO Whitepaper)20, Syros detailed the design of its ongoing Phase 1 trial of SY-5609.
Second Quarter 2020 Financial Results

Cash, cash equivalents and marketable securities as of June 30, 2020 were $108.7 million, compared with $91.4 million of cash, cash equivalents and marketable securities on December 31, 2019. This increase reflects the $20 million upfront payment received in connection with Syros’ entry into a collaboration with Global Blood Therapeutics, Inc. (GBT) in December 2019, the $20 million that Syros drew down from its senior secured loan facility with Oxford Finance, LLC in February 2020, and $12.3 million from the sale of common stock under Syros’ at-the-market sales facility in the first quarter.

For the second quarter of 2020, Syros reported a net loss of $17.2 million, or $0.38 per share, compared to a net loss of $19.5 million, or $0.47 per share, for the same period in 2019.

Revenues were $3.2 million for the second quarter of 2020, compare to $0.5 million for the same period in 2019. In the second quarter of 2020, $2.5 million in revenue was recognized under Syros’ collaboration with GBT and $0.7 million was recognized under its collaboration with Incyte Corporation (Incyte). All revenues recognized in the second quarter of 2019 were under Syros’ collaboration with Incyte.
Research and development (R&D) expenses were $14.8 million for the second quarter of 2020, as compared to $15.5 million for the same period in 2019. This decrease was primarily attributable to the deprioritization of SY-1365.
General and administrative (G&A) expenses were $5.1 million for the second quarter of 2020, as compared to $5.2 million for the same period in 2019.
Financial Guidance

Based on its current plans, Syros believes that its existing cash and cash equivalents will be sufficient to fund its planned operating expenses and capital expenditures requirements into 2022, beyond key milestones expected for both SY-1425 and SY-5609.

Conference Call and Webcast

Syros will host a conference call today at 8:30 a.m. ET to discuss these second quarter 2020 financial results and provide a corporate update.

To access the live conference call, please dial (866) 595-4538 (domestic) or (636) 812-6496 (international) and refer to conference ID 9542188. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the call.

On August 6, 2020 TAE Life Sciences (TLS), a biological-targeting radiation therapy company developing next-generation boron neutron capture therapy solutions (BNCT), reported that Bruce Bauer, Chief Executive Officer, will present a corporate overview at the Summer 2020 Private Company Showcase, hosted by Solebury Trout, on August 10, 2020 (Press release, TAE Life Sciences, AUG 6, 2020, View Source [SID1234563175]).

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Date: Monday, August 10, 2020
Time: 1:40 PM Eastern Time
Location: Virtual Webcast