Relay Therapeutics Reports First Quarter 2021 Financial Results

On May 13, 2021 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading edge computational and experimental technologies, reported first quarter 2021 financial results (Press release, Relay Therapeutics, MAY 13, 2021, View Source [SID1234579929]).

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"Since the start of 2021, we have been laser-focused on our mission for the year – execution. We continue to make progress on our clinical programs – RLY-1971, our SHP2 inhibitor partnered with Genentech, and RLY-4008, our FGFR2 inhibitor. Our PI3Kα mutant selective program is anticipated to enter IND enabling studies this year and we continue to advance our pipeline of precision oncology and genetic diseases programs," said Sanjiv Patel, M.D., president and chief executive officer. "We also made our first acquisition, ZebiAI, as we look to continually bolster our Dynamo platform and become a strategic partner of choice for emerging technologies."

Recent Corporate Highlights

Presented preclinical data for RLY-4008, a potent, selective and oral small molecule inhibitor of FGFR2, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021
Completed the IND transfer of RLY-1971 to Genentech, and Genentech remains on track for the start of a combination trial with their KRAS G12C inhibitor, GDC-6036, in 2021
Acquired ZebiAI, a pioneer in applying massive experimental DNA encoded library data sets to power machine learning for drug discovery (ML-DEL)
Strengthened clinical leadership with the appointments of Tara O’Meara as senior vice president of clinical development operations and Charles Ferté as global medical lead, RLY-4008
Expanded computational leadership with the addition of Patrick Riley as senior vice president of artificial intelligence
First Quarter 2021 Financial Results

Cash, Cash Equivalents and Investments: As of March 31, 2021, cash, cash equivalents and investments totaled approximately $726.1 million, compared to $678.1 million as of December 31, 2020. The Company expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2024. The increase in cash is primarily due to the receipt of Genentech’s $75 million upfront payment in the first quarter, partially offset by cash used to fund our operations.

R&D Expenses: Research and development expenses were $30.6 million for the first quarter of 2021, as compared to $21.7 million for the first quarter of 2020. This increase was primarily due to $5.5 million of additional employee related costs, including an increase in stock-based compensation of $3.3 million, $1.7 million related to increased clinical trial expenses associated with RLY-1971 and RLY-4008, and $1.3 million related to our pre-clinical candidates.

G&A Expenses: General and administrative expenses were $12.7 million for the first quarter of 2021, as compared to $4.8 million for the first quarter of 2020. This increase was primarily due to $6.2 million of increased personnel costs, including increased stock-based compensation of $5.0 million, to support our infrastructure and $1.7 million related to increases in other general and administrative expenses primarily attributed to an increase in insurance expense.

Net Loss: Net loss was $42.2 million for the first quarter of 2021, or a net loss per share of $0.47, as compared to a net loss of $24.9 million for the first quarter of 2020, or a net loss per share of $5.99.

ZAP Surgical and Swiss Neuro Radiosurgery Center (SNRC) Announce Imminent Installation of New Gyroscopic Radiosurgery Platform for Treating Brain Tumors

On May 13, 2021 ZAP Surgical Systems, Inc. reported the imminent installation of its advanced ZAP-X Gyroscopic Radiosurgery platform at the Swiss Neuro Radiosurgery Center (SNRC), an organization within the Swiss Clinical Neuroscience Institute (SCNSI) in Zurich, Switzerland (Press release, ZAP Surgical Systems, MAY 13, 2021, View Source [SID1234579963])

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Stereotactic radiosurgery (SRS) is a well-studied and effective treatment for many brain cancers including primary and metastatic brain tumors, as well as select intracranial functional and vascular disorders. Considered an alternative to surgery for these indications, SRS is a non-invasive outpatient procedure that often provides equivalent to superior outcomes, yet no surgical incision, and little to no recovery period.

The ZAP-X system is recognized for using gyroscopic motion to direct radiosurgical beams from a multitude of unique angles which precisely concentrate radiation to the tumor target, resulting in significantly less healthy brain tissue exposure than those of multi-purpose radiation delivery systems. This unique approach supports the clinical objective of protecting healthy brain tissue and neuro-cognitive function.

ZAP-X is also the first and only dedicated radiosurgery system to no longer require Cobalt-60 radioactive sources, thus eliminating the significant costs to license, secure and regularly replace live radioactive isotopes.

"The local core-team consisting of neurosurgeon Christoph Weber, MD, radiation oncologist Cristina Picardi, MD, and myself are looking forward to putting Switzerland’s first ZAP-X into operation," said Andreas Mack, PHD, founder and chief executive officer of SNRC.

"With an interdisciplinary focus on neuro-radiosurgical treatments, the project is a cooperative effort including the Klinik Hirslanden Institute for Radiotherapy, the Center for Endoscopic and Minimally Invasive Neurosurgery, namely Robert Reisch, MD, and Nikolai Hopf, MD, and the Center for Micro Neurosurgery, namely Ralf Kockro, MD," added Mack. "Additionally, SNRC is scientifically advised by the clinical team at the University Hospital of Basel, Department of Neurosurgery, namely Luigi Mariani, MD, Raphael Guzman, MD, and Ethan Taub, MD."

"ZAP Surgical is excited to partner with SNRC to bring world-class radiosurgery to Zurich and the surrounding communities," said Hakan Baraner, ZAP Surgical’s Senior Vice President for Europe, Middle East, and Africa. "We believe SNRC’s ZAP-X program will serve as an example to many other medical centers, both locally and globally."

SNRC estimates first patient treatments with ZAP-X will commence in the summer of 2021.

Celsius Holdings, Inc. Reports Record First Quarter 2021 Financial Results

On May 13, 2021 Celsius Holdings, Inc., (Nasdaq: CELH), maker of the leading global fitness drink, CELSIUS, reported financial results for the first quarter ended March 31, 2021 (Press release, Celsius Therapeutics, MAY 13, 2021, View Source [SID1234580033]). Management will host a conference call today at 10:00 a.m. Eastern Time to discuss the results with the investment community.

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To participate in the conference call, please call one of the following telephone numbers at least 10 minutes before the start of the call:

FY 2020 (Ended March 31, 2021) Full Year Financial Results

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Quarterly Statement 1st Quarter 2021

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