Market Newsdesk

MONTREAL, May 01, 2023 (GLOBE NEWSWIRE) — CN (TSX: CNR) (NYSE: CNI) announced today that Unifor has ratified its collective agreements with the Company. The collective agreements cover approximately 3,000 CN employees working in various departments such as Mechanical, Intermodal, Facility Management, and in clerical positions in Canada.

“We are pleased that Unifor members have ratified these agreements. Despite the diverse crafts represented by this union, we have been successful in improving alignment on our path forward to deliver better and safer service.”
               — Tracy Robinson, President and Chief Executive Officer, CN

About CN

CN is a world-class transportation leader and trade-enabler. Essential to the economy, to the customers, and to the communities it serves, CN safely transports more than 300 million tons of natural resources, manufactured products, and finished goods throughout North America every year. CN’s network connects Canada’s Eastern and Western coasts with the U.S. South through a 18,600-mile rail network, CN and its affiliates have been contributing to community prosperity and sustainable trade since 1919. CN is committed to programs supporting social responsibility and environmental stewardship.

Contacts



:

Media	Investment Community
Jonathan Abecassis	Stacy Alderson
Senior Manager	Interim Assistant Vice-President
Media Relations	Investor Relations
(438) 455-3692	(514) 399-0052
[email protected]	[email protected]

FIREFLY-1 clinical abstract selected for oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

Leadership team strengthened with executive appointments in clinical development and commercialization

Pre-New Drug Application (NDA) meeting held April 19, 2023 with U.S. Food and Drug Administration (FDA) for tovorafenib (DAY101) for relapsed or progressive pediatric low-grade glioma (pLGG)

Company to host conference call on June 4

^th

at 6:00 PM CT

BRISBANE, Calif., May 01, 2023 (GLOBE NEWSWIRE) — Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its first quarter 2023 financial results and highlighted recent corporate achievements.

“We are excited about our upcoming milestones, including the opportunity to share new clinical data from the FIREFLY-1 trial in an oral presentation at ASCO,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “We are also thrilled to announce the appointment of two industry veterans to Day One’s executive leadership team. Lauren Merendino will join as Chief Commercial Officer and Dr. Raphaël Rousseau will join as Chief Medical Officer. Paired with the promotion of our co-founder Dr. Samuel Blackman to Head of Research and Development, these key appointments will help shape our future and contribute to long-term value creation for the company.”

Program Highlights

• On April 26, 2023, Day One announced new clinical data from the ongoing, open-label, pivotal Phase 2 FIREFLY-1 trial evaluating the investigational agent tovorafenib in relapsed or progressive pLGG will be presented on June 4, 2023, as an oral presentation at the 2023 ASCO Annual Meeting. An ASCO abstract scheduled for release on May 25, 2023 will include topline data from FIREFLY-1 as of September 28, 2022, while new detailed clinical data will be highlighted at the June 4, 2023 oral presentation.
• Two additional posters will be presented on June 5, 2023 in the ASCO Pediatric Oncology session. These include a trial-in-progress poster for the FIREFLY-2 study and a poster describing a healthcare resource utilization study conducted for pLGG patients.
• On April 19, 2023, Day One held a pre-NDA meeting with the FDA for tovorafenib for the treatment of patients with relapsed or progressive pLGG. The company remains in position to initiate the submission of the NDA as early as the second quarter of 2023.
• On April 20, 2023, Day One presented a poster titled “Clinical Activity of the Type II pan-RAF Inhibitor Tovorafenib in BRAF-fusion Melanoma” at the 19^th European Association of Dermato-Oncology (EADO) Congress demonstrating initial antitumor activity in relapsed/refractory adult BRAF-fusion in the ongoing FIRELIGHT-1 study (NCT04985604).
• In March 2023, Day One dosed the first patient in its pivotal Phase 3 FIREFLY-2/LOGGIC clinical trial evaluating tovorafenib as a frontline therapy for patients newly diagnosed with pLGG.

• Patient enrollment continues in the Phase 1b/2 FIRELIGHT-1 trials evaluating tovorafenib as a monotherapy and as a combination with the company’s investigational MEK inhibitor, pimasertib, in adults and adolescents with relapsed, progressive, or refractory solid tumors harboring MAPK pathway aberrations.

Corporate Highlights and Upcoming Milestones

• Samuel C. Blackman, MD, PhD, co-founder and former Chief Medical Officer (CMO), has been promoted to Head of Research and Development. In this role, he will lead the direction of Day One’s overall scientific research and development strategy. Dr. Blackman co-founded Day One and has served as CMO since November 2018. Under his leadership, the company has advanced its lead product candidate tovorafenib into a Phase 2 registrational trial in relapsed or progressive pLGG, a Phase 3 frontline trial in newly diagnosed pLGG and expanded development into evaluating tovorafenib as a monotherapy and as a combination with the investigational MEK inhibitor, pimasertib.

• Lauren Merendino, MBA, will lead Day One’s commercial organization as Chief Commercial Officer (CCO) and will focus on finalizing preparations for the commercial launch of tovorafenib and bringing commercial perspective to key company decisions. Ms. Merendino has over 25 years of commercial experience, building and leading commercial teams through multiple product launches, including both oncology and pediatric rare diseases. Most recently, she was the CCO at Myovant Sciences where she oversaw the successful launch of 2 products across 3 indications in less than 2 years. Previously, she was the VP of Neurological Rare Diseases at Genentech where she led a cross-functional team to launch a new treatment for spinal muscular atrophy, a pediatric rare disease, where the product ultimately became a new standard of care.

• Raphaël Rousseau, MD, PhD, is appointed Chief Medical Officer (CMO) and will focus on executing and expanding Day One’s clinical development programs. Dr. Rousseau was previously the CMO at Neogene Therapeutics and Gritstone Bio. Dr. Rousseau has more than 25 years of global oncology drug development experience and specifically, pediatric oncology clinical trial design. During his long tenure at Roche and Genentech, Dr. Rousseau built a team solely dedicated to developing innovative treatments for children with cancer, led or co-led the pediatric development and registration of bevacizumab, rituximab and capecitabine, and initiated the pediatric development of cobimetinib and atezolizumab in close collaboration with European and North American academic pediatric oncology consortiums.

Fourth Quarter and Full Year 2022 Financial Highlights

• Cash Position: Cash, cash equivalents and short-term investments totaled $318.2 million on March 31, 2023. Based on Day One’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations into 2025.

• R&D Expenses: Research and development expenses were $27.8 million for the first quarter of 2023 compared to $15.0 million for the first quarter of 2022. The increase was primarily due to additional employee compensation costs, as well as clinical trial and pre-commercial manufacturing activities related to Day One’s lead product candidate, tovorafenib.

• G&A Expenses: General and administrative expenses were $18.0 million for the first quarter of 2023 compared to $12.7 million for the first quarter of 2022. The increase was primarily due to additional employee compensation costs, an ongoing commercial buildout, and professional service expenses to support company growth.

• Net Loss: Net loss totaled $42.4 million for the first quarter of 2023 with non-cash stock compensation expense of $9.4 million, compared to $27.7 million for the first quarter of 2022 with non-cash stock compensation expense of $6.2 million.

Upcoming Events

• Day One will present two posters at the 2023 American Society of Pediatric Oncology/Hematology (ASPHO) Conference May 10-13, 2023, focused on the pLGG burden of illness and healthcare utilization data.
• 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, June 2-6, 2023
  • To join the Company’s conference call and webcast on Sunday, June 4, 2023, at 6:00 PM CT, participants can access the conference call live via webcast from the Investors & Media page of Day One’s website.

• Goldman Sachs 44^th Annual Global Healthcare Conference, June 12-15, 2023
• Clinical data from the FIREFLY-1 study have been accepted as an oral presentation at the Society for Neuro-Oncology (SNO) 7th Biennial Pediatric Neuro-Oncology Research Conference from June 23-24, 2023.

About Tovorafenib

Tovorafenib is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which is being investigated in primary brain tumors or brain metastases of solid tumors. Tovorafenib has been studied in over 325 patients to date. Currently tovorafenib is under evaluation in a pivotal Phase 2 clinical trial (FIREFLY-1) among pediatric, adolescent and young adult patients with relapsed or progressive pLGG, which is an area of considerable unmet need with no approved therapies for the vast majority of patients. Tovorafenib is also being evaluated alone or as a combination therapy for adolescent and adult patient populations with relapsed or progressive solid tumors with MAPK pathway aberrations (FIRELIGHT-1).

Tovorafenib has been granted Breakthrough Therapy and Rare Pediatric Disease designations by the U.S. Food and Drug Administration (FDA) for the treatment of patients with pLGG harboring an activating RAF alteration. Tovorafenib (DAY101) has also received Orphan Drug designation from the FDA for the treatment of malignant glioma, and from the European Commission (EC) for the treatment of glioma.

About Day One Biopharmaceuticals

Day One Biopharmaceuticals is a clinical-stage biopharmaceutical company that believes when it comes to pediatric cancer, we can do better. We put kids first and are developing targeted therapies that deliver to their needs. Day One was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. The Company’s name was inspired by “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan. Day One aims to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One.

Day One partners with leading clinical oncologists, families, and scientists to identify, acquire, and develop important emerging cancer treatments. The Company’s lead product candidate, tovorafenib, is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor. The Company’s pipeline also includes pimasertib, an investigational, oral, highly-selective small molecule inhibitor of mitogen‐activated protein kinases 1 and 2 (MEK-1/-2). Day One is based in Brisbane. For more information, please visit www.dayonebio.com or find the company on LinkedIn or Twitter.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Day One’s plans to develop cancer therapies, expectations from current clinical trials, the execution of the Phase 2 and Phase 3 clinical trial for tovorafenib as designed, any expectations about safety, efficacy, timing and ability to complete clinical trials, release data results and to obtain regulatory approvals for tovorafenib and other candidates in development, and the ability of tovorafenib to treat pLGG or related indications.

Statements including words such as “believe,” “plan,” “continue,” “expect,” “will,” “develop,” “signal,” “potential,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements.

Forward-looking statements are subject to risks and uncertainties that may cause Day One’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including Day One’s ability to develop, obtain regulatory approval for or commercialize any product candidate, Day One’s ability to protect intellectual property, the potential impact of global business or macroeconomic conditions, including as a result of the COVID-19 pandemic, inflation and rising interest rates and the sufficiency of Day One’s cash, cash equivalents and investments to fund its operations. These forward-looking statements speak only as of the date hereof and Day One specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

Day One Biopharmaceuticals, Inc.

Consolidated Statements of Operations

(unaudited)

(In thousands)

		Three Months Ended March 31,
			2023				2022
Operating expenses:
Research and development		$	27,828			$	15,003
General and administrative			18,027				12,745
Total operating expenses			45,855				27,748
Loss from operations			(45,855	)			(27,748	)
Investment income, net			3,466				2
Other income (expense), net			(4	)			(1	)
Net loss attributable to common stockholders			(42,393	)			(27,747	)
Net loss per share, basic and diluted		$	(0.59	)		$	(0.48	)
Weighted-average number of common shares used in computing net loss per share, basic and diluted			71,972,888				58,382,444

Day One Biopharmaceuticals, Inc.

Selected Consolidated Balance Sheet Data

(unaudited)

(In thousands)

		March 31, 2023				December 31, 2022
Cash, cash equivalents and short-term investments		$	318,179			$	342,269
Total assets			323,563				349,062
Total liabilities			23,148				17,023
Accumulated deficit			(312,061	)			(269,668	)
Total stockholders’ equity			300,415				332,039

DAY ONE MEDIA
Laura Cooper, Head of Communications
[email protected]

DAY ONE INVESTORS
LifeSci Advisors, PJ Kelleher
[email protected]

LATHAM, N.Y., May 01, 2023 (GLOBE NEWSWIRE) — Plug Power Inc. (NASDAQ: PLUG), a leading provider of turnkey hydrogen solutions for the global green hydrogen economy, unveiled a new high-power stationary fuel cell system for charging commercial electric vehicle (EV) fleets.

Operators deploying commercial electric vehicles face many obstacles, from grid power capacity restrictions to clean power requirements to long waits for grid infrastructure upgrades and installations. As many operators are delaying or forgoing EV adoption due to these challenges, Plug provides operators with a new solution: a clean hydrogen-powered fuel cell system that cost effectively charges EV fleets, getting zero-emission EV vehicles deployed to meet fleet operator’s sustainability and operational goals

“As EV adoption increases dramatically over the next few years and electricity demand strains the grid, our new high-power fuel cell system will be a game changer for the EV industry,” said Jose Luis Crespo, General Manager of Applications and Global Accounts for Plug. “Customers are approaching Plug for hydrogen power generation options, and we expect this offering to be one of the largest applications for stationary use this year.”

Plug has significant interest in this new solution from EV fleet owners such as delivery van fleets, rental car companies with battery EVs, and telecom providers with fleets of maintenance vehicles, as well as public charging networks and EV charger manufacturers.

Plug’s standard 18,000-gallon liquid hydrogen tank combined with its new megawatt-scale PEM fuel cell solution can provide over 60 megawatt hours (MWh) of instantaneous energy – enough to charge more than 600 EVs.

To learn more about this latest offering, visit Plug from May 1-4, at the Advanced Clean Transportation (ACT) Expo in booth #6611, where a 3D model of the fuel cell, hydrogen dispenser with simulated refueling, and fuel cell-powered HYVIA delivery van will be on display.

About Plug

Plug is building an end-to-end green hydrogen ecosystem, from production, storage and delivery to energy generation, to help its customers meet their business goals and decarbonize the economy. In creating the first commercially viable market for hydrogen fuel cell technology, the company has deployed more than 60,000 fuel cell systems and over 180 fueling stations, more than anyone else in the world, and is the largest buyer of liquid hydrogen. With plans to build and operate a green hydrogen highway across North America and Europe, Plug is building a state-of-the-art Gigafactory to produce electrolyzers and fuel cells and multiple green hydrogen production plants that will yield 500 tons of liquid green hydrogen daily by 2025. Plug will deliver its green hydrogen solutions directly to its customers and through joint venture partners into multiple environments, including material handling, e-mobility, power generation, and industrial applications. For more information, visit www.plugpower.com.

Plug Safe Harbor Statement

This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve significant risks and uncertainties about Plug Power Inc. (“PLUG”), including but not limited to statements about: the dramatic increase in EV adoption over the next few years; anticipated interest in Plug’s new high-power fuel cell system from EV fleet owners, as well as public charging networks and EV charger manufacturers. Such statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in these statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of PLUG in general, see PLUG’s public filings with the Securities and Exchange Commission (the “SEC”), including the “Risk Factors” section of PLUG’s Annual Report on Form 10-K for the year ended December 31, 2022 and any subsequent filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements are made as of the date hereof, and PLUG undertakes no obligation to update such statements as a result of new information.

MEDIA CONTACT

Caitlin Coffee
Allison+Partners
[email protected]

SHELTON, Conn., May 01, 2023 (GLOBE NEWSWIRE) — Acme United Corporation (NYSE American: ACU) today announced that the company will present at the Sidoti Micro Cap Virtual Conference on Wednesday, May 10, 2023 at 10:00 AM Eastern Time.

Acme United’s Chairman and Chief Executive Officer Walter Johnsen will also meet one-on-one with institutional investors on Wednesday, May 10 and Thursday, May 11, 2023.

A webcast of Acme United’s presentation and supporting material will be available in the Investor Relations section of the company’s website at: https://acmeunited.gcs-web.com/.

To obtain additional information about Acme United’s participation in the Sidoti Micro Cap Virtual Conference, please contact Sidoti & Company.  

About Acme United

ACME UNITED CORPORATION is a leading worldwide supplier of innovative safety solutions and cutting technology to the school, home, office, hardware, sporting goods and industrial markets. Its leading brands include First Aid Only®, First Aid Central®, PhysiciansCare®, Spill Magic®, Westcott®, Clauss®, Camillus®, Cuda®, DMT®,Med-Nap and Safety Made. For more information, visit www.acmeunited.com.

CONTACT:		Paul G. Driscoll		Acme United Corporation		1 Waterview Drive		Shelton, CT 06484
				Phone: (203) 254-6060		FAX: (203) 254-6521

 

SAN DIEGO, May 01, 2023 (GLOBE NEWSWIRE) — Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced the appointment of Ariella Kelman, MD, as Chief Medical Officer. Dr. Kelman has a proven track record of leading global biopharmaceutical development, clinical trials, and regulatory strategies.

“Dr. Kelman is an outstanding addition to our team as we progress our programs into later stages of development and prepare to enter the clinic with the BT-600 program, which is designed to deliver our unique formulation of tofacitinib to the colon using our proprietary GItrac™ technology,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “Her leadership and experience will be invaluable as we continue our mission to develop needle-free delivery technologies that improve patients’ lives.”

“I’m thrilled to join Biora and help shape the future of therapeutic delivery,” said Dr. Kelman. “As a physician and a drug developer, I see the tremendous potential of Biora’s NaviCap™ and BioJet™ platforms to transform care and improve patient outcomes, beginning with inflammatory bowel disease. I’m looking forward to rapidly advancing the NaviCap platform into the clinic.”

Before joining Biora Therapeutics, Dr. Kelman led clinical development at Human Immunology Biosciences, a clinical-stage company focused on drug discovery and development for immune-mediated conditions. Prior to that, she spent 15 years at Genentech/Roche where she led clinical development programs for several new medicines for adults and children with inflammatory autoimmune diseases and subsequently served as global head of bioethics for Roche. Previously, Dr. Kelman served for ten years as an attending physician in the Division of Immunology and Rheumatology at Stanford University Hospital. Dr. Kelman holds an MD from Tel Aviv University. She completed her residency in internal medicine at Kaiser Hospitals in Los Angeles and Santa Clara and completed fellowships in rheumatology and clinical research at Stanford University Hospital.

About the NaviCap™ Targeted Oral Delivery Platform and BT-600


Biora’s NaviCap targeted oral therapeutics platform
 utilizes a novel approach that could improve IBD patient outcomes by enabling delivery of therapeutics directly to the site of disease, increasing therapeutic levels in tissue while reducing systemic uptake. For the 1.8 million patients in the United States who suffer from inflammatory bowel disease (IBD), existing therapeutics offer less than ideal efficacy, likely because of the challenges with safely achieving sufficient drug levels in the affected tissues. Research has shown that targeted delivery of therapeutics has the potential to improve patient outcomes in IBD. 

The NaviCap platform uses an ingestible device designed for targeted delivery of therapeutics to improve treatment of IBD. Once swallowed, Biora’s GItrac™ autolocation technology enables the device to autonomously identify targeted locations in the GI tract and release a therapeutic dose of up to 500µl. 

Biora’s BT-600 program consists of a unique, liquid formulation of tofacitinib delivered to the colon via the NaviCap device, for the treatment of ulcerative colitis. Studies in healthy volunteers have demonstrated accurate localization and delivery in a fasted state and demonstrated the device’s ability to function in both fasted and fed states, making it potentially the first ingestible therapeutic delivery device that does not require fasting or other food restriction for use. A device function study in participants with active ulcerative colitis (UC) also demonstrated successful device performance in active UC patients. The company plans to submit an Investigational New Drug (IND) application to begin a Phase 1 study with its BT-600 program to evaluate drug concentration in tissue and plasma. 

About Biora Therapeutics

Biora Therapeutics is the biotech company that is reimagining therapeutic delivery. By creating innovative smart pills designed for targeted drug delivery to the GI tract, and systemic, needle-free delivery of biotherapeutics, the company is developing therapies to improve patients’ lives.

Biora is focused on development of two therapeutics platforms: the NaviCap™ targeted oral delivery platform, which is designed to improve outcomes for patients with inflammatory bowel disease through treatment at the site of disease in the gastrointestinal tract, and the BioJet™ systemic oral delivery platform, which is designed to replace injection for better management of chronic diseases through needle-free, oral delivery of large molecules.

For more information, visit bioratherapeutics.com or follow the company on LinkedIn or Twitter.

Notice of Issuance of Inducement Grants

Biora Therapeutics also announced the grant of inducement awards to Dr. Kelman pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. In connection with commencement of employment, Dr. Kelman will be granted two inducement awards consisting of: (i) a stock option award to purchase up to 35,000 shares of Biora Therapeutics common stock, and (ii) a restricted stock unit award representing the right to receive up to 35,000 shares of Biora Therapeutics common stock. The grants will be made on June 15, 2023, and both awards will vest over approximately four years from the grant date. The exercise price of the stock option will equal the closing price of the Company’s common stock on June 14, 2023, the last trading day prior to the date of the grant. The awards were granted as an inducement material to Dr. Kelman’s employment pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

Safe Harbor Statement or Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the progress and future expectations and goals of our research and development and clinical efforts, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan,” “target,” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, our ability to innovate in the field of therapeutics, our ability to make future filings and initiate clinical trials on expected timelines or at all, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding opportunities with current or future pharmaceutical collaborators, our ability to raise sufficient capital to achieve our business objectives, the ongoing COVID-19 pandemic, and those risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC and other subsequent documents, including Quarterly Reports, that we file with the SEC.

Biora Therapeutics expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

Investor Contact

Chuck Padala
Managing Director, LifeSci Advisors
[email protected]
(646) 627-8390

Media Contact

[email protected]

• O
  ver 1,244 Alzheimer’s patients now enrolled in Phase 3 studies of simufilam.
• Completion of patient enrollment for Phase 3 program still expected Q4 2023.
• $187.5 Million Cash and Cash Equivalents at March 31, 2023.
  

AUSTIN, Texas, May 01, 2023 (GLOBE NEWSWIRE) — Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced financial results for the first quarter ended March 31, 2023. Net loss was $24.3 million, or $0.58 per share, compared to a net loss of $17.5 million, or $0.44 per share, for the same period in 2022. Net cash used in operations was $13.3 million during the first quarter of 2023. New guidance for net cash use in first half 2023 is expected to be $30 to $40 million, which is revised downward from our previous guidance of $45 to $50 million, due primarily to the timing of certain clinical payment obligations.

Cassava Sciences is evaluating its lead drug candidate, simufilam, in people with Alzheimer’s disease. Over 1,244 patients with mild-to-moderate Alzheimer’s disease are now enrolled in our Phase 3 program of simufilam, up from over 1,000 enrolled patients as of February 28, 2023. The target enrollment is approximately 1,750 patients.

“In Q1 2023, we announced results of a one-year, open-label Phase 2 safety study of simufilam in over 200 patients with Alzheimer’s disease,” said Remi Barbier, President & CEO. “The dataset for this study shows long-term safety for simufilam. Notably, the data also show differences in changes in ADAS-Cog scores in mild and moderate subgroups. We believe this is an encouraging result, as it clearly shows an improvement in ADAS-Cog over 1 year in mild patients taking simufilam that is well outside the expected range of historical placebo decline from numerous other studies.”

Mr. Barbier continued, “Looking forward, our top priority is to complete patient enrollment for our Phase 3 program. We also look forward to announcing science updates, including completion of patient dosing for our Cognition Maintenance Study. In this randomized, placebo-controlled study, over 100 patients with mild-to-moderate Alzheimer’s who completed at least one year of open-label treatment with simufilam are subsequently randomized to placebo or simufilam for six months. This is known as a randomized, withdrawal study design. While complex, I think this study design may yield interesting clinical data in Q3. Separately, in Q2 we expect to announce new evidential data for the biological activity of simufilam on filamin A protein.”

Financial Results for First Quarter 2023

• At March 31, 2023, cash and cash equivalents were $187.5 million, with no debt.
• Net loss was $24.3 million, or $0.58 per share. This compares to a net loss of $17.5 million, or $0.44 per share, for the same period in 2022. Net loss increased due primarily to increases in the rate of patient enrollment and associated costs to conduct the Phase 3 clinical program, as well as other studies with simufilam.
• Net cash used in operations was $13.3 million during the first quarter of 2023.
• Net cash use in operations for the first half 2023 is now expected to be $30 to $40 million, compared to previous guidance of $45 to $50 million due primarily to the timing of certain payment obligations for studies of simufilam.
• Research and development (R&D) expenses were $22.1 million. This compared to $14.9 million for the same period in 2022. R&D expenses increased due primarily to increasing patient enrollment and costs to conduct the Phase 3 clinical program, as well as other studies with simufilam.
• General and administrative (G&A) expenses were $4.4 million. This compared to $2.9 million for the same period in 2022. G&A expenses increased due primarily to increased activities and expenses related to legal services.

About Cassava Sciences’ Phase 3 Program
We are conducting a Phase 3 clinical evaluation of simufilam in people with Alzheimer’s disease dementia. This program consists of two on-going, randomized, double-blind, placebo-controlled studies. Both Phase 3 studies have received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration. The Phase 3 program is recruiting a total of approximately 1,750 patients with mild-to-moderate Alzheimer’s disease who also meet other study eligibility criteria. Our Phase 3 studies are actively recruiting Alzheimer’s patients in over 100 clinical sites in the United States, Canada, Puerto Rico, South Korea and Australia. For detailed information about Cassava Sciences’ Phase 3 program, please visit the website for ClinicalTrials.gov: https://ClinicalTrials.gov/ct2/show/NCT04994483?term=simufilam&draw=2&rank=3

About Simufilam
Simufilam is a novel drug candidate designed to treat and slow the progression of Alzheimer’s disease. Simufilam binds tightly to an altered conformation of the filamin A protein (FLNA) that is present in the brain of the Alzheimer’s patient and is critical to the toxicity of Aβ42. Simufilam is wholly owned by Cassava Sciences, without royalty or payment obligation to any third party.

About Cassava Sciences, Inc.
Cassava Sciences is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. Our novel science is based on stabilizing—but not removing—a critical protein in the brain. Our product candidates have not been approved by any regulatory authority, and their safety, efficacy or other desirable attributes have not been established. For more information, please visit our website: https://www.CassavaSciences.com

For More Information Contact:

Eric Schoen, Chief Financial Officer
(512) 501-2450
[email protected]

Cautionary Note Regarding Forward-Looking Statements:

This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that may include but are not limited to: our strategy and plans; the size and scope of our pivotal Phase 3 trial and its likelihood of success; the interpretation of clinical data generated in our open-label study; the timing of clinical results of the Cognition Maintenance Study; the treatment of Alzheimer’s disease dementia; the status of current and future clinical studies with simufilam, including anticipated patient enrollment goals in 2023 for our Phase 3 studies; the safety or efficacy of simufilam in patients; the release of evidential data by a third-party related to the biological activity of simufilam; the use of mass spectrometry as an alternative method of detection for SavaDx or the timing of new data release for SavaDx; expected cash use in future periods; verbal commentaries made by our employees; and potential benefits, if any, of the our product candidates. These statements may be identified by words such as “may,” “anticipate,” “believe,” “could,” “expect,” “forecast,” “intend,” “plan,” “possible,” “potential,” and other words and terms of similar meaning.

Simufilam and SavaDx are investigational product candidates. They are not approved by any regulatory authority and their safety, efficacy or other desirable attributes have not been established in patients. All clinical data from our open-label study are inherently exploratory in nature and, as with all open-label data, should be interpreted with caution. Data results from our open-label study does not constitute, and should not be interpreted as, clinical evidence of therapeutic safety or benefit for simufilam.

Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Clinical results and analyses of our open-label study should not be relied upon as predictive of Phase 3 studies or any other study. Our clinical results from earlier-stage clinical trials may not be indicative of full results or results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish.

Such statements are based largely on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct or complete clinical studies on expected timelines, to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates, any unanticipated impacts of inflation on our business operations, and including those described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, and future reports to be filed with the SEC.
The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement.
In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this news release. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC’s website at


www.sec.gov


.

– Financial Tables Follow –

CASSAVA SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
	Three months ended March 31,
	2023				2022
Operating expenses
Research and development, net of grant reimbursement	$	22,120			$	14,906
General and administrative		4,392				2,915
Total operating expenses		26,512				17,821
Operating loss		(26,512	)			(17,821	)
Interest income		2,051				31
Other income, net		190				263
Net loss	$	(24,271	)		$	(17,527	)
Net loss per share, basic and diluted	$	(0.58	)		$	(0.44	)
Weighted-average shares used in computing net loss per share, basic and diluted		41,739				39,962
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
	March 31, 2023				December 31, 2022
Assets
Current assets
Cash and cash equivalents	$	187,467			$	201,015
Prepaid expenses and other current assets		7,532				10,211
Total current assets		194,999				211,226
Property and equipment, net		22,609				22,864
Operating lease right-of-use assets		—				122
Intangible assets, net		503				622
Total assets	$	218,111			$	234,834
Liabilities and stockholders’ equity
Current liabilities
Accounts payable and accrued expenses	$	8,242			$	4,017
Accrued development expense		5,276				2,280
Accrued compensation and benefits		212				170
Operating lease liabilities, current		—				104
Other accrued liabilities		179				492
Total current liabilities		13,909				7,063
Operating lease liabilities, non-current		—				35
Other non- current liabilities		197				197
Total liabilities		14,106				7,295
Stockholders’ equity
Common Stock and additional paid-in-capital		511,828				511,091
Accumulated deficit		(307,823	)			(283,552	)
Total stockholders’ equity		204,005				227,539
Total liabilities and stockholders’ equity	$	218,111			$	234,834

 

BEIJING, May 01, 2023 (GLOBE NEWSWIRE) — Chindata Group Holdings Limited (“Chindata Group” or the “Company”) (Nasdaq: CD), a leading carrier-neutral hyperscale data center solution provider in Asia-Pacific emerging markets, today announced that it has filed its annual report on Form 20-F for the fiscal year ended December 31, 2022 with the Securities and Exchange Commission on April 28, 2023 US Eastern Time. The annual report can be accessed on the Company’s investor relations website at https://investor.chindatagroup.com/.

The Company will provide a hard copy of its annual report containing the audited consolidated financial statements, free of charge, to its shareholders and ADS holders upon request. Requests should be submitted to [email protected].

About Chindata Group

Chindata Group is a leading carrier-neutral hyperscale data center solution provider in Asia-Pacific emerging markets and a first mover in building next-generation hyperscale data centers in China, India and Southeast Asia markets, focusing on the whole life cycle of facility planning, investment, design, construction and operation of ecosystem infrastructure in the IT industry. Chindata Group provides its clients with business solutions in major countries and regions in Asia-Pacific emerging markets, including asset-heavy ecosystem chain services such as industrial bases, data centers, network and IT value-added services.

Chindata Group operates two sub-brands: “Chindata” and “Bridge Data Centres”. Chindata operates hyper-density IT cluster infrastructure in the Greater Beijing Area, the Yangtze River Delta Area and the Greater Bay Area, the three key economic areas in China, and has become the engine of the regional digital economies. Bridge Data Centres, with its top international development and operation talents in the industry, owns fast deployable data center clusters in Malaysia and India, and seeks business opportunities in other Asia-Pacific emerging markets.

For Enquiries, Please Contact:

Chindata IR Team
[email protected]