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Deutsche Bank Increases Prime Lending Rate to 8.00%

Deutsche Bank Increases Prime Lending Rate to 8.00%

NEW YORK–(BUSINESS WIRE)–
Deutsche Bank today announced that its New York Branch, Deutsche Bank New York (DBNY), and its affiliate Deutsche Bank Trust Company Americas (DBTCA) have increased their prime lending from 7.75% to 8.00% effective tomorrow, March 23, 2023.

About Deutsche Bank

Deutsche Bank provides commercial and investment banking, retail banking, transaction banking and asset and wealth management products and services to corporations, governments, institutional investors, small and medium-sized businesses, and private individuals. Deutsche Bank is Germany’s leading bank, with a strong position in Europe and a significant presence in the Americas and Asia Pacific.

This release contains forward-looking statements. Forward-looking statements are statements that are not historical facts; they include statements about our beliefs and expectations and the assumptions underlying them. These statements are based on plans, estimates and projections as they are currently available to the management of Deutsche Bank. Forward-looking statements therefore speak only as of the date they are made, and we undertake no obligation to update publicly any of them in light of new information or future events.

By their very nature, forward-looking statements involve risks and uncertainties. A number of important factors could therefore cause actual results to differ materially from those contained in any forward-looking statement. Such factors include the conditions in the financial markets in Germany, in Europe, in the United States and elsewhere from which we derive a substantial portion of our revenues and in which we hold a substantial portion of our assets, the development of asset prices and market volatility, potential defaults of borrowers or trading counterparties, the implementation of our strategic initiatives, the reliability of our risk management policies, procedures and methods, and other risks referenced in our filings with the U.S. Securities and Exchange Commission. Such factors are described in detail in our SEC Form 20-F of 11 March 2016 under the heading “Risk Factors”. Copies of this document are readily available upon request or can be downloaded from www.db.com/ir.

Deutsche Bank

Dylan Riddle

[email protected]

212-250-4982

Press and Media Relations

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Banking Professional Services Finance

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CN Files its Management Information Circular

MONTREAL, March 22, 2023 (GLOBE NEWSWIRE) — CN (TSX: CNR) (NYSE: CNI) today filed its Management Information Circular (Proxy) and announced that the 2023 Annual General Meeting will take place virtually on April 25, 2023.

Board Nominees

The Proxy includes the nomination of candidates for the Board of Directors. Nine of the 11 nominees were elected at previous AGMs. Two nominee directors, Michel Letellier and Al Monaco, are standing for election for their first time.
  
Mr. Letellier, 58, is the President and Chief Executive Officer of Montreal headquartered Innergex Renewable Energy Inc., one of the largest Canadian independent renewable power producers with operations in Canada, the United States, France and Chile. Mr. Letellier has extensive North American business experience, and he has been a driving force in the renewable energy industry with Innergex since 1997 and as President and Chief Executive Officer since 2007. Previously, Mr. Letellier was responsible for the development and operation of hydroelectric projects for Boralex Inc. Mr. Letellier’s extensive business and strategic experience, sustainability leadership and record of entrepreneurship, combined with financial acumen and a track record of business accomplishments, make him an exceptional member of the Board. Mr. Letellier is an experienced director having served on public and private boards since 2012 and has served on CN’s board since October 1, 2022.

Mr. Monaco, 63, a new nominee, was until his retirement on January 1, 2023, the President and Chief Executive Officer of Enbridge Inc. (“Enbridge”), an energy infrastructure company. Appointed as President, Chief Executive Officer and a Director of Enbridge in 2012, Mr. Monaco led Enbridge through a period of transformational growth combined with an intensified focus on safety, reliability and environmental protection that has positioned it as North America’s leading diversified energy delivery company. Mr. Monaco brings decades-long experience overseeing a large, complex, federally regulated and geographically diverse organization, including the operations and management of capital intensive long-linear infrastructure, the deployment of operating technology, as well as sustainability and strategic planning. This experience will provide CN with invaluable insight into executive leadership, safety and reliability, customer experience, corporate governance, finance, mergers and acquisitions, strategic planning, investor relations, ESG, people and talent management, government, regulatory and public policy and a global experience and perspective.

“We are pleased to put forward these two outstanding nominees. Michel has been a tremendous asset since joining our board in October. His financial acumen and successful track record in business, not only in Quebec but globally, have provided valuable insight. Al is a well-known Canadian businessman with a deep knowledge of energy and complex infrastructure, like CN’s network. The combined experience and expertise of Michel and Al make them exceptional additions to our Board.”

  • Shauneen Bruder, Chair of the Board of CN.

Annual General Meeting

CN will hold its 2023 annual general meeting of shareholders on April 25, 2023 at 10:00 a.m. (Eastern Daylight Time). The meeting will be conducted via live webcast. This format embraces the latest webcast meeting technology to provide easy access and live communication for our shareholders. Shareholders will be able to participate in the meeting and submit questions for consideration. The audio webcast of the meeting will be available at www.virtualshareholdermeeting.com/CNI2023.

The company’s Management Information Circular and Notice of Annual Meeting of Shareholders, its 2022 Annual Report, and the 2022 Annual Information Form and Form 40-F are available in the Investors’ section of CN’s website. Meeting materials are being mailed to shareholders and will include their control number and instructions on how to vote their shares and access the webcast the day of the meeting. Instructions will also be posted on the Investors’ section of CN’s website.

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. As the only railroad connecting 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 Paul Butcher
Senior Manager Vice-President
Media Relations Investor Relations
438-455-3692
[email protected]		 (514) 399-0052
[email protected]



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U.S. Bank Increases Prime Lending Rate to 8.00 Percent

U.S. Bank Increases Prime Lending Rate to 8.00 Percent

MINNEAPOLIS–(BUSINESS WIRE)–
U.S. Bancorp (NYSE: USB) announced it has increased its prime lending rate to 8.00 percent from 7.75 percent, at all U.S. Bank locations. The reference rate at all Union Bank locations will also increase to 8.00 percent from 7.75 percent. These changes are effective tomorrow, March 23, 2023.

About U.S. Bancorp:

U.S. Bancorp, with approximately 77,000 employees and $675 billion in assets as of December 31, 2022, is the parent company of U.S. Bank National Association. The Minneapolis-based company serves millions of customers locally, nationally and globally through a diversified mix of businesses: Consumer and Business Banking; Payment Services; Corporate & Commercial Banking; and Wealth Management and Investment Services. Union Bank, consisting primarily of retail banking branches on the West Coast, joined U.S. Bancorp in 2022. The company has been recognized for its approach to digital innovation, social responsibility, and customer service, including being named one of the 2022 World’s Most Ethical Companies and Fortune’s most admired superregional bank. Learn more at usbank.com/about.

Investor contact:

George Andersen, Director of Investor Relations, U.S. Bancorp Investor Relations – 612.303.3620; [email protected]

Media contact:

Jeff Shelman, U.S. Bancorp Public Affairs and Communications – 612.303.9933; [email protected]

KEYWORDS: United States North America Minnesota

INDUSTRY KEYWORDS: Banking Professional Services Finance

MEDIA:

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Tempest Reports Year End 2022 Financial Results and Provides Business Update

  • Positive monotherapy and combination therapy data from Phase 1 trial of first clinical program, TPST-1120, announced in an oral presentation at ASCO 2022
  • TPST-1120 randomized combination study in first-line HCC patients with partner Roche is fully enrolled, with initial data expected in the first half of 2023
  • New data on TPST-1120 biomarker and proprietary small molecule TREX1 inhibitor accepted for presentation at AACR 2023
  • TPST-1495 Phase 1 monotherapy and combination dose escalation and optimization ongoing, with initial data release planned by mid 2023

BRISBANE, Calif., March 22, 2023 (GLOBE NEWSWIRE) — Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, today reported financial results for the year ended December 31, 2022 and provided a corporate update.

“2022 featured significant milestones for the company, including our first clinical proof of concept data, which was recognized in an oral presentation at ASCO,” said Stephen Brady, chief executive officer of Tempest. “We were pleased to see TPST-1120 confer clinical benefit to patients, including a 30% ORR at the two highest doses in patients who had not responded to checkpoint inhibitors or who had cancer that doesn’t traditionally respond to immunotherapy. We look forward to data this year from our randomized global study with Roche in first-line liver cancer patients, as well as our second clinical program, TPST-1495, where we’ve observed disease control in late-stage cancer patients, as well as data from our exciting preclinical program targeting TREX1 in the STING pathway. 2023 is shaping up to be a data-rich year for Tempest.”

2022 Accomplishments

  • TPST-1120 (clinical PPARα antagonist): (i) completed Phase 1 clinical study investigating TPST-1120, as a monotherapy and in combination with an anti-PD1 therapy, nivolumab, and selected recommended Phase 2 dose (“RP2D”); (ii) announced positive results including RECIST responses from the Phase 1 study in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting; (iii) presented data showing pharmacodynamic and predictive biomarkers associated with responses in cancer patients from the Phase 1 study at the 2022 Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting; and (iv) continued enrollment in first-line, randomized global Phase 1b/2 study in patients with hepatocellular carcinoma (HCC), under a collaboration with F. Hoffmann La Roche.  
  • TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) completed enrollment in a Phase 1 study evaluating monotherapy dose and schedule optimization; (ii) continued enrollment of a study evaluating combination dose and schedule optimization with the anti-PD-1 checkpoint inhibitor, pembrolizumab; and (iii) presented preclinical data showing the superiority of targeting EP2 and EP4 together in comparison to other prostaglandin pathway approaches at both the American Association for Cancer Research (AACR) Annual Meeting 2022 and SITC 2022.
  • TREX1 Inhibitor (preclinical tumor-selective STING pathway activator): presented the first preclinical anti-tumor results with proprietary small molecule TREX1 inhibitor at AACR 2022.
  • Expansion of Patent Portfolio: the U.S. Patent and Trademark Office issued a patent covering methods of treatment for our therapeutic product candidate, TPST-1495.

Planned Near-Term Milestones

  • TPST-1120 (clinical PPARα antagonist): we expect to (i) present new data showing an association of RECIST responses and biomarker changes at AACR 2023; and (ii) report objective response data from up to 40 HCC patients in each arm in the first-line randomized study in the first half of 2023.
  • TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): we plan to disclose data from (i) the Phase 1 dose escalation and schedule optimization trial studying monotherapy and combination therapy with an anti-PD1 therapy, pembrolizumab, by mid-2023, and (ii) a separate combination arm at the two highest TPST-1495 doses in patients with advanced endometrial cancer in 2024.
  • TREX1
    Inhibitor (preclinical tumor-selective STING pathway activator): we expect to present new preclinical anti-tumor results at AACR 2023 with new proprietary small molecule series TREX1 inhibitors generated through insights resulting from human TREX1-inhibitor co-crystal structures.

Financial Results

Year End 2022

  • Tempest ended the year with $31.2 million in cash and cash equivalents, compared to $51.8 million on December 31, 2021. The decrease was primarily due to cash used in operations of $31.1 million, as well as $4.7 million repayment of principal on our loan, offset by net proceeds from the issuance of common stock of $8.9 million and pre-funded warrants of $7.3 million.
  • Net loss and net loss per share for the year were $35.7 million and $3.09, respectively, compared to $28.3 million and $7.47, respectively, for the same period in 2021.
  • Research and development expenses for the year were $22.5 million compared to $17.2 million for the same period in 2021. The $5.3 million increase was primarily attributable to expanded research and development efforts and higher compensation expenses due to an increase in employee headcount.
  • General and administrative expenses for the year were 2022 were $12.1 million compared to $9.8 million for the same period in 2021. The increase of $2.3 million was primarily due to professional and consulting fees and insurance expense.
  • Based on current cash position and operating plan, Tempest expects to have sufficient resources to fund operations through the second quarter of 2024.

About Tempest Therapeutics

Tempest Therapeutics is a clinical-stage oncology company advancing small molecules that combine both tumor-targeted and immune-mediated mechanisms with the potential to treat a wide range of tumors. The company has a diverse portfolio of novel programs ranging from early research to investigation in a randomized global study in first-line cancer patients. The company’s two novel clinical programs, TPST-1120 and TPST-1495, target PPARα and EP2/EP4, respectively, and are advancing through trials designed to study the agents as monotherapies and in combination with approved agents. Tempest is also developing an orally available inhibitor of TREX1, a target that controls activation of the cGAS/STING pathway. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company’s website at www.tempesttx.com.

Forward-Looking Statements

This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the “Securities Act”)) concerning Tempest Therapeutics, Inc.. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest Therapeutics, as well as assumptions made by, and information currently available to, management of Tempest Therapeutics. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “could”, “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions. All statements that are not historical facts are forward-looking statements, including any statements regarding: the design, initiation, progress, timing, scope and results of clinical trials; anticipated therapeutic benefit and regulatory development of Tempest Therapeutic’s product candidates; the Company’s ability to deliver on value-creating milestones; the Company’s guidance regarding cash runway, as well as our operational plans. Forward-looking statements are based on information available to Tempest Therapeutics as of the date hereof and are not guarantees of future performance. Any factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied are discussed in greater detail in the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 and other documents filed by the Company from time to time with the Securities and Exchange Commission. Except as required by applicable law, Tempest Therapeutics undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest Therapeutics’ views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Tempest Therapeutics.

TEMPEST THERAPEUTICS, INC.  
Consolidated Balance Sheets  
(in thousands)  
         
  December 31, 2022 December 31, 2021  
Assets        
Current assets        
Cash and cash equivalents $ 31,230     $ 51,829    
Insurance recovery of legal settlement   450       15,000    
Prepaid expenses and other current assets   1,270       2,134    
Total current assets   32,950       68,963    
         
Property and equipment, net   1,060       1,113    
Operating lease right-of-use assets   11,650       3,051    
Other noncurrent assets   429       111    
         
Total assets $ 46,089     $ 73,238    
         
Liabilities and Stockholders’ Equity        
Current liabilities        
Accounts payable $ 1,108     $ 991    
Accrued legal settlement   450       15,000    
Accrued expenses and other   2,961       1,589    
Current operating lease liabilities   1,413       1,442    
Accrued compensation   1,248       912    
Interest payable   97       92    
Total current liabilities   7,277       20,026    
         
Loan payable, net   10,371       15,069    
Operating lease liabilities   10,330       2,026    
Total liabilities   27,978       37,121    
         
Stockholders’ equity        
Common stock   11       7    
Additional paid-in capital   153,872       136,173    
Accumulated deficit   (135,772 )     (100,063 )  
Total stockholders’ equity   18,111       36,117    
Total liabilities and stockholders’ equity $ 46,089     $ 73,238    
         
TEMPEST THERAPEUTICS, INC.  
Consolidated Statements of Operations  
(in thousands except per share amounts)  
           
           
    Twelve months ended   Twelve months ended  
    December 31, 2022   December 31, 2021  
Expenses:          
Research and development   $ 22,527     $ 17,166    
General and administrative     12,113       9,820    
           
Total expenses     34,640       26,986    
           
Operating loss     (34,640 )     (26,986 )  
           
Other income (expense), net:      
Interest expense     (1,618 )     (1,282 )  
Interest and other income, net     549       (34 )  
           
Net loss   $ (35,709 )   $ (28,302 )  
Net loss per share   $ (3.09 )   $ (7.47 )  
           

Investor Contacts:

Sylvia Wheeler
Wheelhouse Life Science Advisors
[email protected]

Aljanae Reynolds
Wheelhouse Life Science Advisors
[email protected]

1 If approved by the FDA

 



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Northern Trust Raises Prime Rate

Northern Trust Raises Prime Rate

CHICAGO–(BUSINESS WIRE)–
Northern Trust has increased its prime rate from 7.75% to 8.00%, effective Thursday, March 23, 2023.

About Northern Trust

Northern Trust Corporation (Nasdaq: NTRS) is a leading provider of wealth management, asset servicing, asset management and banking to corporations, institutions, affluent families and individuals. Founded in Chicago in 1889, Northern Trust has a global presence with offices in 25 U.S. states and Washington, D.C., and across 23 locations in Canada, Europe, the Middle East and the Asia-Pacific region. As of December 31, 2022, Northern Trust had assets under custody/administration of US$13.6 trillion, and assets under management of US$1.2 trillion. For more than 130 years, Northern Trust has earned distinction as an industry leader for exceptional service, financial expertise, integrity and innovation. Visit us on northerntrust.com. Follow us on Twitter @NorthernTrust or Northern Trust Corporation on LinkedIn.

Northern Trust Corporation, Head Office: 50 South La Salle Street, Chicago, Illinois 60603 U.S.A., incorporated with limited liability in the U.S. Global legal and regulatory information can be found at https://www.northerntrust.com/terms-and-conditions.

Media Contact:

Doug Holt

Northern Trust

(312) 557-1571

[email protected]

http://www.northerntrust.com

KEYWORDS: United States North America Illinois

INDUSTRY KEYWORDS: Banking Asset Management Professional Services Finance

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Cidara Therapeutics and Melinta Therapeutics Announce FDA Approval ofREZZAYO™ (rezafungin for injection) for the Treatment of Candidemia and Invasive Candidiasis

Cidara Therapeutics and Melinta Therapeutics Announce FDA Approval ofREZZAYO™ (rezafungin for injection) for the Treatment of Candidemia and Invasive Candidiasis

– REZZAYO is a novel, once-weekly, next-generation echinocandin indicated for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options –

– REZZAYO is the first new FDA-approved echinocandin in over a decade –

SAN DIEGO & PARSIPPANY, N.J.–(BUSINESS WIRE)–Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Melinta Therapeutics, LLC today announced that the U.S. Food and Drug Administration (FDA) approved REZZAYO™ (rezafungin for injection) for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade.

“The FDA approval of REZZAYO represents a significant milestone for Cidara, and for patients confronted with difficult-to-treat and often deadly candidemia and invasive candidiasis,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “I am extremely proud of all of the Cidara employees who collectively advanced REZZAYO from preclinical development to NDA approval and am grateful to the many patients and healthcare teams who have participated in the clinical studies.”

George Thompson, M.D., principal investigator in the ReSTORE trial and professor of clinical medicine at the University of California, Davis, School of Medicine, added, “The FDA approval of REZZAYO is tremendous news for those of us who have been hoping for a new option to treat our patients with these deadly fungal infections. Based on the totality of clinical data generated, REZZAYO has the potential to simplify the management of invasive candidiasis and enhance the continuity of echinocandin care.”

The FDA approval of once-weekly REZZAYO was based on clinical data from Cidara’s global ReSTORE Phase 3 trial and supported by the STRIVE Phase 2 clinical trial and extensive non-clinical development program. In clinical studies, REZZAYO, dosed once-weekly, met the FDA and EMA primary endpoints, demonstrating statistical non-inferiority versus caspofungin, a current once-daily standard of care. In addition, overall rates of adverse events and serious adverse events were comparable in patients receiving REZZAYO and caspofungin, while rates of adverse events leading to study drug discontinuation were also similar for REZZAYO and caspofungin. Based on Qualified Infectious Disease Product (QIDP) designation, REZZAYO was approved under Priority Review.

Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, added, “We are thrilled that the FDA has approved REZZAYO, and are firmly committed to offering this innovative therapy to address unmet medical needs and simplify the treatment for patients suffering from invasive Candida infections. We intend to leverage our expansive commercial infrastructure and experience launching anti-infective drugs into acute care settings. We are working closely with Cidara and anticipate bringing REZZAYO, a differentiated once-weekly treatment to patients, this summer.”

Last year, Melinta announced that it had acquired the exclusive rights to commercialize REZZAYO in the U.S. from Cidara. Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma in all other geographies. The European Medicines Agency (EMA) accepted the marketing authorization application (MAA) for rezafungin in August 2022 and it is currently under review.

About REZZAYO™ (rezafungin for injection)

REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism.

INDICATIONS AND USE

REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.

REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

IMPORTANT SAFETY INFORMATION

REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

REZZAYOmay cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.

REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.

Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy.

Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com.

About Cidara Therapeutics

Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of new approaches aimed at transforming existing treatment and prevention paradigms leveraging drug-Fc conjugates (DFCs) targeting viral and oncological diseases from Cidara’s proprietary Cloudbreak® platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

About Melinta Therapeutics

Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our commercial portfolio currently includes the newly approved REZZAYO (rezafungin for injection), in addition to six commercial-stage products: Baxdela® (delafloxacin), Kimyrsa® (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), TOPROL-XL® (metoprolol succinate) and Vabomere® (meropenem and vaborbactam).

With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. For additional information, including product and respective important safety information, please visit our website.

TOPROL-XL® is a registered trademark of the AstraZeneca group of companies.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether REZZAYO will be commercially available for patients during summer 2023, whether REZZAYO, if available, will be prescribed by physicians or will represent an important treatment option for patients with serious fungal infections. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as delays in action by regulatory authorities due to limitations on inspections and other COVID-19-related effects, and impacts of the COVID-19 pandemic or other obstacles on the enrollment of patients or other aspects of rezafungin development. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

Investor Contact:

Brian Ritchie

LifeSci Advisors

(212) 915-2578

[email protected]

Media Contact:

Veronica Eames

LifeSci Communications

646-970-4682

[email protected]

Melinta Contact:

Susan Blum

908-617-1300

[email protected]

KEYWORDS: California New Jersey United States North America

INDUSTRY KEYWORDS: Surgery Infectious Diseases FDA Hospitals Clinical Trials Biotechnology Other Health Health Pharmaceutical

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Golden Minerals Reports Full Year 2022 Results

Golden Minerals Reports Full Year 2022 Results

GOLDEN, Colo.–(BUSINESS WIRE)–
Golden Minerals Company (“Golden Minerals,” “Golden” or the “Company”) (NYSE-A: AUMN and TSX: AUMN) has today released financial results and a business summary for the full fiscal year ending December 31, 2022. (All figures are in approximate U.S. dollars.)

Business Summary

  • At the Rodeo mine, 2022 payable production was 11,982 ounces (“oz.”) gold in doré and 52,179 oz. silver, with average realized sales prices of $1,805/oz. gold and $21.93/oz. silver. Total cash costs per payable gold oz.1 were $1,362, while plant recovery for gold averaged 74.7% for the full year 2022.
  • At the Velardeña Properties, the Company continued to evaluate modified mine plans and mining techniques. Work studies are designed to address dilution issues encountered in the first half of 2022 and include new test work on automated ore sorting, which shows potential to allow for upgrading mined material by rejecting waste rock after crushing. The results of these studies are expected in mid-2023.
  • At the district-scale Yoquivo silver-gold project, the Company has reported the first ever mineral resource estimate for the project.
  • The Company completed second and third drill programs at the Sarita Este gold-silver prospect in Salta, Argentina, and released results that point toward a potentially economic shallow oxidized gold system.

Financial Summary

  • Revenue of $23.3 million related to the sale of metals from the Company’s Rodeo mine in 2022, vs. $25.6 million in 2021.
  • Net operating margin (defined as revenue from the sale of metals less cost of metals sold) of $5.7 million related to Rodeo mine operations in 2022 vs. $12.3M in 2021.
  • $4.0 million cash and equivalents balance as of December 31, 2022, compared to $12.2 million on December 31, 2021.
  • Zero debt as of December 31, 2022, unchanged from December 31, 2021.
  • Exploration expenses of $9.6 million in 2022 vs. $5.3 million in 2021.
  • Net loss of $9.9 million or $0.06 per share in 2022 compared to a net loss of $2.1 million or $0.01 per share in 2021.

2022 Cash Inflows and Expenditures

Cash inflows during 2022 totaled $7.9 million and included:

  • $5.7 million of net operating margin from the Rodeo operation;
  • $1.0 million from the exercise of outstanding warrants;
  • $0.8 million, net of fees from the sale of common stock under the ATM Program; and
  • $0.4 million related to changes in working capital.

2022 expenditures totaled $16.1 million and included the following:

  • $9.6 million in exploration expenditures, including $4.3 million of exploration and mining activities at Rodeo, Yoquivo, Sarita Este and other properties, $1.8 million for expanding a tailings facility at Velardeña and $1.5 million to support the potential restart of Velardeña;
  • $1.4 million in care and maintenance costs at the Velardeña Properties;
  • $0.6 million in exploration and evaluation activities, care and maintenance and property holding costs at the El Quevar project, net of reimbursements from Barrick; and
  • $4.5 million in G&A expenses, including costs for employee compensation, directors’ fees, professional fees, insurance and other costs.

Capital Resources and 2023 Financial Outlook

Forecasted expenditures during the 12 months ending December 31, 2023, apart from Rodeo cost of metals sold which is already included in the forecast of net operating margin shown below, total approximately $8.5 million, which is $7.6 million lower than the $16.1 million in expenditures incurred during 2022. These forecasted expenditures include: (i) exploration expenses of $2.6 million, (ii) Velardeña care and maintenance costs of $1.2 million, (iii) El Quevar spending (net of Barrick reimbursements) of $0.8 million, and (iv) administrative expense of $3.9 million. The actual amount of cash expenditures that the Company incurs during the 12-month period ending December 31, 2023 may vary significantly from the amounts specified above and will depend on a number of factors, including variations in the anticipated care and maintenance costs at the Velardeña Properties or at El Quevar, and costs for continued exploration, project assessment, and advancement of the Company’s other exploration properties.

The Company does not currently have sufficient resources to meet its expected cash needs during the year ending December 31, 2023. On December 31, 2022, Golden had cash resources of approximately $4.0 million. The forecasted net operating margin from the Rodeo Property during the current year is expected to be between a loss of $0.5 million and a positive margin of $0.5 million. Net operating margin is defined as revenue from the sale of metals less the cost of metals sold, which includes the full Torreon office G&A costs and project costs. The estimate assumes average gold and silver prices per ounce during the period of $1,800 and $20.00, respectively. The actual amount that the Company receives in net operating margin from Rodeo during the period may vary significantly from the amounts specified above due to, among other things: (i) unanticipated variations in grade, (ii) unexpected challenges associated with the Company’s proposed mining plan, (iii) decreases in commodity prices below those used in calculating the estimates shown above, (iv) variations in expected recoveries, (v) increases in operating costs above those used in calculating the estimates shown above, or (vi) interruptions in mining at Rodeo.

To meet its liquidity needs during the year, Golden Minerals plans to sell non-core assets and seek equity financing, including through the use of its at-the-market (ATM) program or otherwise. The combined amount of cash needed to be raised from asset sales, the ATM program, or other equity raises to cover forecast expenditures during the 12 months ended December 31, 2023, is between $4.5 million and $5.5 million.

On February 28, 2023, the Company’s aggregate cash and cash equivalents totaled approximately $1.8 million. In the absence of sufficient asset sales, equity financing or other external funding, the Company’s cash balance is expected to be depleted in the second quarter of 2023.

Annual Report on Form 10-K

The Company’s consolidated audited financial statements and management’s discussion and analysis, as well as other important disclosures, may be found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. This Form 10-K is available on the Company’s website at Golden Minerals Company – SEC Filings. It has also been filed with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov./edgar.shtml and with the Canadian securities regulatory authorities on SEDAR at www.sedar.com.

Footnotes

1 Cash cost per payable gold ounce is a non-GAAP financial measure. “Total cash costs, net of by-product credits, per payable gold ounce,” includes all direct and indirect operating cash costs associated with the physical activities that would generate doré products for sale to customers, including mining to gain access to mineral resources, mining of mineral resources and waste, milling, third-party related treatment, refining and transportation costs, on-site administrative costs and royalties. Total cash costs do not include depreciation, depletion, amortization, exploration expenditures, reclamation and remediation costs, sustaining capital, financing costs, income taxes, or corporate general and administrative costs not directly or indirectly related to the Rodeo project. By-product credits include revenues from silver contained in the products sold to customers during the period. “Total cash costs, net of by-product credits” are divided by the number of payable gold ounces produced by the plant for the period to arrive at “Total cash costs, net of by-product credits, per payable gold ounce.”

About Golden Minerals

Golden Minerals is a gold and silver producer based in Golden, Colorado. The Company is primarily focused on producing gold and silver from its Rodeo Mine, advancing its Velardeña and Yoquivo properties in Mexico and, through partner-funded exploration, its El Quevar silver property in Argentina, as well as acquiring and advancing selected mining properties in Mexico, Nevada and Argentina.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and applicable Canadian securities legislation, including statements regarding the Company’s liquidity forecast for 2023, plans to sell non-core assets and seek equity financing in the near term and the amount of proceeds needed to cover forecasted expenditures; the Company’s expectations regarding the depletion of its cash balance in the second quarter of 2023; and the timing for completion of work studies designed to address dilution issues at theVelardeña Properties. These statements are subject to risks and uncertainties, including the timing, duration and overall impact of the COVID-19 pandemic, including the potential future re-suspension of non-essential activities in Mexico, including mining; increases in costs and declines in general economic conditions; changes in political conditions, in tax, royalty, environmental and other laws in the United States, Mexico or Argentina and other market conditions; and fluctuations in silver and gold prices. Golden Minerals assumes no obligation to update this information. Additional risks relating to Golden Minerals may be found in the periodic and current reports filed with the SEC by Golden Minerals, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.

For additional information, please visit http://www.goldenminerals.com/.

Golden Minerals Company

Karen Winkler, Director of Investor Relations

(303) 839-5060

KEYWORDS: Colorado United States North America

INDUSTRY KEYWORDS: Communications Natural Resources Mining/Minerals Public Relations/Investor Relations

MEDIA:

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Cidara Therapeutics and Melinta Therapeutics Announce FDA Approval of REZZAYO™ (rezafungin for injection) for the Treatment of Candidemia and Invasive Candidiasis

– REZZAYO is a novel, once-weekly, next-generation echinocandin indicated for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options –

– REZZAYO is the first new FDA-approved echinocandin in over a decade –

SAN DIEGO and PARSIPPANY, N.J., March 22, 2023 (GLOBE NEWSWIRE) — Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Melinta Therapeutics, LLC today announced that the U.S. Food and Drug Administration (FDA) approved REZZAYO™ (rezafungin for injection) for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade.

“The FDA approval of REZZAYO represents a significant milestone for Cidara, and for patients confronted with difficult-to-treat and often deadly candidemia and invasive candidiasis,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “I am extremely proud of all of the Cidara employees who collectively advanced REZZAYO from preclinical development to NDA approval and am grateful to the many patients and healthcare teams who have participated in the clinical studies.”

George Thompson, M.D., principal investigator in the ReSTORE trial and professor of clinical medicine at the University of California, Davis, School of Medicine, added, “The FDA approval of REZZAYO is tremendous news for those of us who have been hoping for a new option to treat our patients with these deadly fungal infections. Based on the totality of clinical data generated, REZZAYO has the potential to simplify the management of invasive candidiasis and enhance the continuity of echinocandin care.”

The FDA approval of once-weekly REZZAYO was based on clinical data from Cidara’s global ReSTORE Phase 3 trial and supported by the STRIVE Phase 2 clinical trial and extensive non-clinical development program. In clinical studies, REZZAYO, dosed once-weekly, met the FDA and EMA primary endpoints, demonstrating statistical non-inferiority versus caspofungin, a current once-daily standard of care. In addition, overall rates of adverse events and serious adverse events were comparable in patients receiving REZZAYO and caspofungin, while rates of adverse events leading to study drug discontinuation were also similar for REZZAYO and caspofungin. Based on Qualified Infectious Disease Product (QIDP) designation, REZZAYO was approved under Priority Review.

Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, added, “We are thrilled that the FDA has approved REZZAYO, and are firmly committed to offering this innovative therapy to address unmet medical needs and simplify the treatment for patients suffering from invasive Candida infections. We intend to leverage our expansive commercial infrastructure and experience launching anti-infective drugs into acute care settings. We are working closely with Cidara and anticipate bringing REZZAYO, a differentiated once-weekly treatment to patients, this summer.”

Last year, Melinta announced that it had acquired the exclusive rights to commercialize REZZAYO in the U.S. from Cidara. Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma in all other geographies. The European Medicines Agency (EMA) accepted the marketing authorization application (MAA) for rezafungin in August 2022 and it is currently under review.

About REZZAYO™
 (rezafungin for injection)

REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism.

INDICATIONS AND USE

REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.

REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

IMPORTANT SAFETY INFORMATION

REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.

REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.

Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy.

Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com.

About Cidara Therapeutics

Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of new approaches aimed at transforming existing treatment and prevention paradigms leveraging drug-Fc conjugates (DFCs) targeting viral and oncological diseases from Cidara’s proprietary Cloudbreak® platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

About Melinta Therapeutics

Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our commercial portfolio currently includes the newly approved REZZAYO (rezafungin for injection), in addition to six commercial-stage products: Baxdela® (delafloxacin), Kimyrsa® (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), TOPROL-XL® (metoprolol succinate) and Vabomere® (meropenem and vaborbactam).

With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. For additional information, including product and respective important safety information, please visit our website.

TOPROL-XL® is a registered trademark of the AstraZeneca group of companies.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether REZZAYO will be commercially available for patients during summer 2023, whether REZZAYO, if available, will be prescribed by physicians or will represent an important treatment option for patients with serious fungal infections. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as delays in action by regulatory authorities due to limitations on inspections and other COVID-19-related effects, and impacts of the COVID-19 pandemic or other obstacles on the enrollment of patients or other aspects of rezafungin development. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

Investor Contact:

Brian Ritchie
LifeSci Advisors
(212) 915-2578
[email protected]

Media Contact:

Veronica Eames
LifeSci Communications
646-970-4682
[email protected]

Melinta Contact:

Susan Blum
908-617-1300
[email protected]



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Citizens Financial Group Announces Prime Rate Change

Citizens Financial Group Announces Prime Rate Change

PROVIDENCE, R.I.–(BUSINESS WIRE)–
Citizens Financial Group, Inc. (NYSE: CFG) announced today that Citizens Bank, N.A. has raised its prime lending rate to 8.00 percent from 7.75 percent, effective Thursday, March 23, 2023.

About Citizens Financial Group, Inc.

Citizens Financial Group, Inc. is one of the nation’s oldest and largest financial institutions, with $226.7 billion in assets as of December 31, 2022. Headquartered in Providence, Rhode Island, Citizens offers a broad range of retail and commercial banking products and services to individuals, small businesses, middle-market companies, large corporations and institutions. Citizens helps its customers reach their potential by listening to them and by understanding their needs in order to offer tailored advice, ideas and solutions. In Consumer Banking, Citizens provides an integrated experience that includes mobile and online banking, a full-service customer contact center and the convenience of approximately 3,400 ATMs and approximately 1,100 branches in 14 states and the District of Columbia. Consumer Banking products and services include a full range of banking, lending, savings, wealth management and small business offerings. In Commercial Banking, Citizens offers a broad complement of financial products and solutions, including lending and leasing, deposit and treasury management services, foreign exchange, interest rate and commodity risk management solutions, as well as loan syndication, corporate finance, merger and acquisition, and debt and equity capital markets capabilities. More information is available at www.citizensbank.com or visit us on Twitter, LinkedIn or Facebook.

Frank Quaratiello

617.543.9810

[email protected]

KEYWORDS: United States North America Rhode Island

INDUSTRY KEYWORDS: Banking Professional Services Finance

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Senti Bio Reports Fourth Quarter and Full Year 2022 Financial Results and Reviews Recent Highlights

– SENTI-202 on track to submit an Investigational New Drug (IND) application in second half of 2023 for treatment of CD33 and/or FLT3 expressing hematologic malignancies including AML and MDS –

– Preclinical data from multiple Gene Circuit enhanced CAR NK programs to be presented at American Association for Cancer Research (AACR) Annual Meeting in April 2023 –

– Cash, cash equivalents, and short-term investments of $98.6 million as of December 31, 2022; continue to expect cash runway through at least 1Q 2024 –

SOUTH SAN FRANCISCO, Calif., March 22, 2023 (GLOBE NEWSWIRE) — Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a biotechnology company innovating next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the fourth quarter and full year ended December 31, 2022.

“2022 was a year of important progress for Senti in developing Gene Circuit enhanced next-generation cell therapies that are designed to precisely target cancer cells and overcome the complex tumor environment in oncology. We advanced our product candidates towards clinical development by selecting the lead development candidate in our SENTI-202 program, and expanded our manufacturing capabilities with the ongoing build out of our cGMP facility,” said Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio. “Importantly, in 2022 we became a public company and are well positioned in 2023 to continue to be at the forefront of the synthetic biology field as we prepare to submit our first IND application for SENTI-202, continue to advance our pipeline programs, and establish robust clinical-scale manufacturing of CAR NK cells. Furthermore, our ongoing collaboration efforts to develop next-generation cell and gene therapies in areas outside of oncology with Spark Therapeutics and BlueRock Therapeutics underscore our continued leadership position in Gene Circuits.”

Recent CAR-NK Cell Oncology Pipeline and Gene Circuit Platform Highlights:

  • Announced strategic plan to focus research and development efforts on lead oncology candidate SENTI-202 for the treatment CD33 and/or FLT3 expressing hematologic malignancies including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), to continue to advance SENTI-401 through preclinical studies to target colorectal cancer and other CEA-positive solid tumors, and to pursue strategic geographic partnerships for clinical development of SENTI-301A for liver cancer, of which there is high prevalence in Asian territories.
  • Presented SENTI-202 preclinical data at the American Society of Hematology (ASH) meeting in December 2022 highlighting the use of Logic Gating Gene Circuits to target and eliminate AML cells while sparing healthy hematopoietic stem cells (HSCs). The in vitro and in vivo data demonstrated the ability of SENTI-202 to broadly kill primary leukemic blasts and leukemic stem cells, as well as relevant AML cell lines, while concurrently protecting healthy human HSCs.
  • Initiated IND-enabling studies for SENTI-202 to support a planned Phase 1 trial with submission of an IND application to the FDA anticipated in the second half of 2023.
  • Initiated process and analytical technology transfer to Senti Bio’s Alameda current good manufacturing practice (cGMP) facility to support clinical-scale manufacturing for the company’s CAR NK cell development candidates.
  • Announced presentation of three abstracts highlighting preclinical data from the company’s Gene Circuit CAR NK cell oncology pipeline including SENTI-202, the calibrated release IL-15 Gene Circuit technology, and SENTI-301A, at the AACR Annual Meeting taking place April 14-19, 2023, in Orlando, Florida.
  • Presented preclinical proof-of-concept data from the SENTI-401 CAR NK cell therapy development program at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2022 that showed robust anti-cancer functionality of Logic Gated, Multi-Armed CAR NK cells against a variety of colorectal cancer (CRC) models, including durable activity in vivo; Senti Bio is continuing to advance the SENTI-401 program through preclinical studies intended to support development candidate selection.
  • Achieved discovery-stage objectives supporting continued advancement of next-generation Smart Sensor cell-type and cell-state specific promoters for various non-oncology indications in collaboration with Spark Therapeutics, and advanced a Regulator Dial Gene Circuit designed to enable small molecule-controlled release of cytokines/ “safety switches” in collaboration with BlueRock Therapeutics.

Fourth Quarter and Full Year 2022 Financial Results

  • Cash, Cash Equivalents and Short-term Investments: As of December 31, 2022, Senti Bio held cash, cash equivalents and short-term investments of $98.6 million, which the Company believes is sufficient to fund operations through at least the first quarter of 2024.
  • R&D Expenses: Research & development expenses were $9.2 million for the quarter ended December 31, 2022, compared to $6.4 million for the same period in 2021. Research and development expenses for the year ended December 31, 2022 were $34.1 million, compared to $22.0 million in 2021. The increase includes an additional $2.7 million in non-cash stock-based compensation expense.
  • G&A Expenses: General and administrative expenses were $10.9 million for the fourth quarter of 2022, compared to $5.3 million for the same period in 2021. General and administrative expenses for the year ended December 31, 2022 were $40.8 million, compared to $21.3 million in 2021. The increase includes an additional $11.4 million in non-cash stock-based compensation expense.
  • Net Loss: Net loss was $18.2 million, or $0.42 per basic and diluted share, for the quarter ended December 31, 2022. Net loss for the year ended December 31, 2022, was $58.2 million, or $2.23 per share, compared to a net loss of $55.3 million, or $19.00 per share, in 2021.
  • CapEx: Capital expenditures were $8.5 million for the quarter ended December 31, 2022, primarily driven by the GMP manufacturing facility buildout and related equipment purchases.

About Senti Bio

Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases using novel and unprecedented approaches. To accomplish this, we are building a synthetic biology platform that may enable us to program next-generation cell and gene therapies with what we refer to as Gene Circuits. These novel and proprietary Gene Circuits are designed to reprogram cells with biological logic to sense inputs, compute decisions and respond to their cellular environments. We aim to design Gene Circuits to improve the intelligence of cell and gene therapies in order to enhance their therapeutic effectiveness, precision, and durability against a broad range of diseases that conventional medicines do not readily address.

Our synthetic biology platform utilizes off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cells, outfitted with Gene Circuit technologies, to target particularly challenging liquid and solid tumor oncology indications. Our lead product candidate is SENTI-202 for the treatment of CD33 and/or FLT3 expressing hematologic malignancies, such as acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Additionally, our SENTI-401 program is being designed for the treatment of colorectal cancer (CRC) and other CEA-positive cancers. We have also demonstrated in preclinical studies the potential breadth of our Gene Circuits in other modalities, including T cells, adeno-associated viruses (AAVs) and induced pluripotent stem cells (iPSCs), and diseases outside of oncology; and we have executed partnerships with Spark Therapeutics and BlueRock Therapeutics to advance these capabilities.

Forward-Looking Statements

This press release and document contain certain statements that are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally are identified by the words “believe,” “could,” “predict,” “continue,” “ongoing,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” “forecast,” “seek,” “target” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations of Senti Bio’s management and assumptions, whether or not identified in this document, and, as a result, are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of financial and cash runway and the sufficiency of such cash runway, Senti Bio’s ability to continue to advance its pipeline of preclinical programs and product candidates, Senti Bio’s research and development activities, the generation and release of additional preclinical data, commencement of IND-enabling studies and the timing of submission of IND filings, plans for a Phase 1 clinical trial, and GMP manufacturing start up activities, as well as statements about the potential attributes and benefits of Senti Bio’s product candidates and platform technology and the continuation of its collaborations with Spark Therapeutics and BlueRock Therapeutics. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Senti Bio. Many factors could cause actual future results to differ materially from the forward-looking statements in this document, including but not limited to: (i) Senti Bio’s ability to implement business plans, forecasts and other expectations, (ii) changes in domestic and foreign business, market, financial, political and legal conditions, (iii) changes in the competitive and highly regulated industries in which Senti Bio operates, variations in operating performance across competitors, changes in laws and regulations affecting Senti Bio’s business, (iv) the ability to implement business plans, forecasts and other expectations, (v) the risk of downturns and a changing regulatory landscape in Senti Bio’s highly competitive industry, (vi) risks relating to the uncertainty of any projected financial information with respect to Senti Bio, (vii) risks related to uncertainty in the timing or results of Senti Bio’s preclinical studies, IND filings, and GMP manufacturing startup activities, (viii) Senti Bio’s dependence on third parties in connection with preclinical and IND-enabling studies, IND filings, and GMP manufacturing buildout and startup activities, (ix) risks related to delays and other impacts from macroeconomic and geopolitical events, including changing conditions from the COVID-19 pandemic, increasing rates of inflation and rising interest rates on business operations, and (x) the success of any future research and development efforts by Senti Bio. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Senti Bio’s Quarterly Report on Form 10-Q, filed with the SEC on November 10, 2022, and other documents filed by Senti Bio from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements in this document. There may be additional risks that Senti Bio does not presently know, or that Senti Bio currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements in this document. Forward-looking statements speak only as of the date they are made. Senti Bio anticipates that subsequent events and developments may cause Senti Bio’s assessments to change. Except as required by law, Senti Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.

Availability of Other Information About Senti Biosciences, Inc.

For more information, please visit the Senti Bio website at https://www.sentibio.com or follow Senti Bio on Linkedin (Senti Biosciences). Investors and others should note that we communicate with our investors and the public using our company website (www.sentibio.com), including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on social media. The information that we post on our website or on social media could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Find more information at sentibio.com
Follow us on Linkedin: Senti Biosciences

Senti Biosciences, Inc.

Unaudited Selected Consolidated Balance Sheet Data

(in thousands)

    December 31,   December 31,
    2022     2021  
         
Cash and cash equivalents   $ 57,621   $ 56,034  
Short-term investments     40,942     —  
Restricted cash     3,366     3,257  
Property and equipment, net     56,136     12,368  
Operating lease right-of-use assets     18,418     20,708  
Total assets     180,792     96,702  
Total liabilities     53,529     36,326  
Redeemable convertible preferred stock     —     171,833  
Total stockholders’ equity (deficit)     127,263     (111,457 )
               



Senti Biosciences, Inc.

Unaudited Consolidated Statements of Operations

(in thousands, except share and per share data)

    Three Months Ended   Year Ended
    December 31,   December 31,
      2022       2021       2022       2021  
                 
Total revenue   $ 59     $ 793     $ 4,286     $ 2,761  
Operating expenses:                
Research and development     9,163       6,409       34,067       21,957  
General and administrative     10,912       5,269       40,848       21,250  
Total operating expenses     20,075       11,678       74,915       43,207  
Loss from operations     (20,016 )     (10,885 )     (70,629 )     (40,446 )
Total other income (expense), net     1,806       (19 )     12,419       (14,873 )
Net loss     (18,210 )     (10,904 )     (58,210 )     (55,319 )
Other comprehensive loss     1       —       1       —  
Comprehensive loss   $ (18,209 )   $ (10,904 )   $ (58,209 )   $ (55,319 )
                 
Net loss per share, basic and diluted   $ (0.42 )   $ (3.69 )   $ (2.23 )   $ (19.00 )
Weighted-average shares outstanding, basic and diluted     43,823,607       2,955,009       26,110,785       2,912,275   



Contact Senti Bio:
[email protected]

Media:
Kelli Perkins
[email protected]