Zoetis Announces Appointment of Glenn David as Group President and Wetteny Joseph as Executive Vice President and Chief Financial Officer

Zoetis Announces Appointment of Glenn David as Group President and Wetteny Joseph as Executive Vice President and Chief Financial Officer

PARSIPPANY, N.J.–(BUSINESS WIRE)–
Zoetis Inc. (NYSE:ZTS) today announced leadership changes that will accelerate its long-term growth strategy in key markets and add new talent to its executive team. Glenn David, Executive Vice President and Chief Financial Officer (CFO) for Zoetis, has been named Executive Vice President and Group President, overseeing International Operations and other business units, effective June 1, 2021. In addition, the company announced Wetteny Joseph will join Zoetis as Executive Vice President and Chief Financial Officer, reporting to CEO Kristin Peck, and assume responsibility for the oversight of the company’s financial management, planning, and business development group, effective June 1, 2021.

“Glenn’s record of success at Zoetis, plus his deep knowledge of our operations and the animal health industry, make him the ideal leader to drive Zoetis’ next phase of global growth in international markets, aquaculture, biodevices and pet insurance,” said Chief Executive Officer Kristin Peck. “As CFO for the last five years and a leader in animal health for a decade, Glenn has been a champion for building our business. He has played a pivotal role in supporting our recent product launches, scrutinizing new business opportunities, and investing in global expansion initiatives. We are very excited by the strong leadership qualities and experience Glenn will bring to this role.”

“The Board and I are also excited to welcome Wetteny, a proven leader in healthcare whose global experience and results-driven approach will help ensure that Zoetis continues its strong growth trajectory,” said Peck. “Wetteny has impeccable CFO credentials from his years at Catalent, and he has built world-class Finance organizations and strong relationships with the investment community. I am confident that he will continue to enhance the reputation Zoetis has built for our market performance, value creation and leadership in animal health.”

As GroupPresident, David will oversee Zoetis’ international operations, including China and Brazil, two of the company’s largest and fastest-growing markets. He will also be responsible for the company’s aquaculture business (PHARMAQ), Global BioDevices, and Pumpkin Pet Insurance.

“I am very proud of what we have accomplished at Zoetis over the last eight years, and I see even greater opportunities ahead with an innovative portfolio that is addressing critical needs and defining new standards of care for animals,” said David. “I am excited to take on a more customer-facing role leading our commercial teams, and I look forward to helping accelerate our long-term growth in international markets, where we see untapped opportunities for our products and services.”

As CFO, Joseph will report directly to Chief Executive Officer Kristin Peck and become part of the Zoetis Executive Team. He brings with him valuable financial expertise and deep experience in the healthcare industry from 13 years at Catalent, a global leader in pharmaceuticals, biologics and consumer health products. During his career, he has worked across diverse and complex businesses, leading finance functions and business units, and managing relationships with stakeholders from customers to investors.

“I am delighted with the tremendous opportunity to join a world leading company like Zoetis,” said Joseph. “Zoetis has been delivering sustainable revenue and earnings growth since its launch, while also introducing innovative new products for customers. I look forward to bringing my skills and experience to Zoetis and building on that strong track record of performance with Kristin and the team.”

About Glenn David

Since becoming CFO in 2016, David, age 49, has supported the company’s ability to consistently grow revenue faster than the market and grow adjusted net income faster than revenue. He has supported the company’s investments in future growth through sound business development and capital allocation strategies. He has maintained a well-capitalized and financially disciplined business, creating significant value for shareholders. Earlier in his career, David served as Senior Vice President of Finance Operations for Zoetis during its Initial Public Offering in 2013. Before the Zoetis IPO, David served in various financial roles at Pfizer, including Vice President of Global Finance for Pfizer Animal Health and Vice President of Finance for the U.S. Primary Care franchise.

About Wetteny Joseph

Joseph, age 49, has served as Senior Vice President and Chief Financial Officer of Catalent since 2018. He joined Catalent in 2008 as Vice President and Corporate Controller and held various senior finance roles until October 2015, when he was named President, Clinical Supply Services, one of the company’s principal business units. Before joining Catalent, Joseph held a variety of senior financial positions at the industrial distribution company HD Supply including CFO for its $1.2 billion plumbing and HVAC business unit. He also served as Corporate Controller at Hughes Supply, a Fortune 500, NYSE-listed company that was acquired by Home Depot and became part of HD Supply. In his early career, Mr. Joseph spent six years at PricewaterhouseCoopers as an auditor and strategic financial advisor across a variety of industries.

About Zoetis

As the world’s leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After nearly 70 years innovating ways to predict, prevent, detect, and treat animal illness, Zoetis continues to stand by those raising and caring for animals worldwide – from livestock farmers to veterinarians and pet owners. The company’s leading portfolio and pipeline of medicines, vaccines, diagnostics, and technologies make a difference in over 100 countries. In 2020, Zoetis generated revenue of $6.7 billion with ~11,300 employees. For more, visit www.zoetis.com.

DISCLOSURE NOTICES

Forward-Looking Statements: This press release contains forward-looking statements, which reflect the current views of Zoetis with respect to business plans or prospects and other future events. These statements are not guarantees of future performance or actions. Forward-looking statements are subject to risks and uncertainties. If one or more of these risks or uncertainties materialize, or if management’s underlying assumptions prove to be incorrect, actual results may differ materially from those contemplated by a forward-looking statement. Forward-looking statements speak only as of the date on which they are made. Zoetis expressly disclaims any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. A further list and description of risks, uncertainties and other matters can befound in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, including in the sections thereof captioned “Forward-Looking Statements and Factors That May Affect Future Results” and “Item 1A. Risk Factors,” in our Quarterly Reports on Form 10-Q and in our Current Reports on Form 8-K. Such risks and uncertainties may be amplified by the COVID-19 pandemic and its potential impact on the global economy and our business. These filings and subsequent filings are available online at www.sec.gov, www.zoetis.com, or on request from Zoetis.

ZTS-IR

ZTS-COR

Media Contacts:

Bill Price

1-973-443-2742 (o)

[email protected]

Kristen Seely

1-973-443-2777 (o)

[email protected]

Investor Contacts:

Steve Frank

1-973-822-7141 (o)

[email protected]

Keith Gaub

1-973-822-7154 (o)

[email protected]

KEYWORDS: New Jersey United States North America

INDUSTRY KEYWORDS: Professional Services Health Genetics Insurance Biotechnology Veterinary

MEDIA:

Logo
Logo

Applied Therapeutics Reports First Quarter 2021 Financial Results

Phase 2 pilot study of AT-007 initiated in patients with SORD Deficiency

NDA submission for AT-007 in Galactosemia expected no later than Q3 2021; commercial preparations ongoing

Completion of enrollment in ARISE-HF Phase 3 global registrational study of AT-001 in Diabetic Cardiomyopathy on track for mid-2021

Ended 1Q21 with a strong balance sheet of $148.1 in cash and cash equivalents and short-term investments

NEW YORK, May 11, 2021 (GLOBE NEWSWIRE) — Applied Therapeutics, Inc. (Nasdaq: APLT) (“Applied Therapeutics” or the “Company”), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today reported financial results for the first quarter ended March 31, 2021.

“In the first quarter we continued to progress our late stage programs towards commercialization in Galactosemia and Diabetic Cardiomyopathy, while advancing our additional rare disease programs in SORD and PMM2-CDG,” said Shoshana Shendelman, PhD, Founder, CEO and Chair of the Board of Applied Therapeutics. “We are looking forward to our planned NDA submission in Galactosemia in the third quarter of this year, and continue to focus on our primary objective – bringing drugs to patients in desperate need of treatment.”

Recent Highlights

  • Initiated Phase 2 Study of AT-007 in Patients with SORD Deficiency. The Phase 2 pilot study of AT-007 in patients with Sorbitol Dehydrogenase Deficiency (SORD Deficiency), a progressive, debilitating hereditary neuropathy that affects peripheral nerves and motor neurons, has been initiated. Preclinical findings demonstrate that AT-007 has the potential to be the first disease-modifying therapy for SORD, targeting the underlying cause of disease.
  • Presented Data on Galactosemia Disease Progression at the 2021 Annual Clinical Genetics Meeting of the American College of Medical Genetics and Genomics. In April 2021, the Company presented data featuring a cross-sectional analysis of nineteen pediatric patients with Classic Galactosemia, providing meaningful insight on the progressive worsening of the central nervous system phenotype with age.
  • Hosted Virtual Rare Disease Forum. In March 2021, the Company hosted a virtual forum highlighting its AT-007 development programs in Galactosemia, SORD Deficiency, and PMM2-CDG. A replay of the presentation, which featured several rare disease key opinion leaders, is available at https://www.appliedtherapeutics.com/presentations-and-publications/.
  • Announced Restart of Pediatric Galactosemia Study. In February 2021, the Company announced that the FDA lifted the clinical hold on the AT-007 ACTION-Galactosemia Kids pediatric clinical study, and the study resumed immediately. Applied Therapeutics worked closely with FDA to modify the trial, with the shared goal of ensuring that all patients have the opportunity to receive clinical benefit, and remains on target to submit an NDA no later than Q3 2021.

  • Closed Approximately $75 million Public Offering. In February 2021, the Company completed an underwritten public offering of 3,450,000 shares of its common stock, including the exercise in full of the underwriters’ option to purchase 450,000 additional shares of common stock at a price of $23.00 per share, resulting in aggregate net proceeds of approximately $74.4 million.

Financial Results

  • Cash and cash equivalents and short-term investments totaled $148.1 million as of March 31, 2021, compared with $96.8 million at December 31, 2020.

  • Research and development expenses for the three months ended March 31, 2021 were $14.4 million, compared to $7.3 million for the three months ended March 31, 2020. The increase of $7.2 million was primarily related to an increase in clinical and pre-clinical expense of $1.3 million, related to the progression of the AT-007 ACTION-Galactosemia adult extension study, the AT-007 ACTION-Galactosemia Kids pediatric registrational study and the AT-001 Phase 3 ARISE-HF clinical study; an increase in drug manufacturing and formulation costs of $5.2 million related to the progression of the manufacturing campaigns and the completion and release of AT-001 and AT-007 drug product batches; an increase in personnel expenses of $0.3 million due to the increase in headcount in support of our clinical program pipeline; an increase in stock-based compensation of $0.2 million due to new stock option and restricted stock unit grants; and an increase in regulatory and other expenses of $0.2 million relating to an increase in clinical consulting fees during the three months ended March 31, 2021.

  • General and administrative expenses were $9.8 million for the three months ended March 31, 2021, compared to $5.2 million for the three months ended March 31, 2020. The increase of approximately $4.6 million was primarily related to an increase of $1.9 million related to the establishment of a commercial department; an increase in stock-based compensation of $1.5 million and increase in personnel expenses of $0.9 million related to an increase in headcount; an increase of $0.2 million related to increased insurance costs; an increase of $0.4 million in other expenses relating to increased costs of rent and other office expenses; and a $0.4 million decrease in legal and professional fees due to lower external legal fees.
  • Net loss for the first quarter of 2021 was $24.2 million, or $1.00 per basic and diluted common share, compared to a net loss of $12.4 million, or $0.59 per basic and diluted common share, for the first quarter 2020.

About Applied Therapeutics

Applied Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need. The Company’s lead drug candidate, AT-007, is a novel central nervous system penetrant aldose reductase inhibitor (ARI) for the treatment of Galactosemia, a rare pediatric metabolic disease. The Company initiated a pivotal Phase 1/2 clinical trial in June 2019, read out positive top-line biomarker data in adult Galactosemia patients in January 2020 and announced full data from the trial in April 2020. A pediatric Galactosemia study commenced in June 2020. The Company is also developing AT-001, a novel potent ARI that is being developed for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart. The Company initiated a Phase 3 registrational study in DbCM in September 2019. The preclinical pipeline also includes AT-003, an ARI designed to cross through the back of the eye when dosed orally, for the treatment of diabetic retinopathy, as well as novel dual PI3k inhibitors in preclinical development for orphan oncology indications.

Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the timing of our NDA submission for potential approval of AT-007, which will include data from the ACTION-Galactosemia Kids trial and the 90-day safety data in adults with Galactosemia, (ii) the timing of our rare disease franchise expansion programs in SORD Deficiency and PMM2-CDG, (iii) the timing of the initiation and completion of our clinical trials, (iv) the likelihood that data from our clinical trials will support future development of our product candidates and (v) the likelihood of obtaining regulatory approval of our product candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved.

Such risks and uncertainties include, without limitation, (i) our plans to develop and commercialize our product candidates, (ii) the initiation, timing, progress and results of our current and future preclinical studies and clinical trials and our research and development programs, (iii) our ability to take advantage of expedited regulatory pathways for any of our product candidates, (iv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing, (v) our ability to successfully acquire or license additional product candidates on reasonable terms, (vi) our ability to maintain and establish collaborations or obtain additional funding, (vii) our ability to obtain regulatory approval of our current and future product candidates, (viii) our expectations regarding the potential market size and the rate and degree of market acceptance of such product candidates, (ix) our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources, (x) the implementation of our business model and strategic plans for our business and product candidates, (xi) our intellectual property position and the duration of our patent rights, (xii) developments or disputes concerning our intellectual property or other proprietary rights, (xiii) our expectations regarding government and third-party payor coverage and reimbursement, (xiv) our ability to compete in the markets we serve, (xv) the impact of government laws and regulations and liabilities thereunder, (xvi) developments relating to our competitors and our industry, (xvii) the impact of the COVID-19 pandemic on the timing and progress of our ongoing clinical trials and our business in general and (xviii) other factors that may impact our financial results. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. Factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Contacts

Investors:

Maghan Meyers or Brendan Burns
(212) 600-1902 or
[email protected]

Media:

[email protected]


Applied Therapeutics, Inc.

Statement of Operations

(in thousands, except share and per share data)

(Unaudited)

               
    Three Months Ended  
    March 31,   
    2021     2020    
OPERATING EXPENSES:              
Research and development   $ 14,448     $ 7,271    
General and administrative     9,751       5,196    
Total operating expenses     24,199       12,467    
LOSS FROM OPERATIONS     (24,199 )     (12,467 )  
OTHER INCOME (EXPENSE), NET:              
Interest income (expense), net     76       122    
Other income (expense)     (56 )     (24 )  
Total other income (expense), net     20       98    
Net loss   $ (24,179 )   $ (12,369 )  
Net loss attributable to common stockholders—basic and diluted   $ (24,179 )   $ (12,369 )  
Net loss per share attributable to common stockholders—basic and diluted   $ (1.00 )   $ (0.59 )  
Weighted-average common stock outstanding—basic and diluted     24,135,735       20,840,658    
                   

Applied Therapeutics, Inc.

Balance Sheet

(in thousands, except share and per share data)

               
    As of   As of  
    March 31,    December 31,  
    2021     2020    
    (Unaudited)      
ASSETS              
CURRENT ASSETS:                
Cash and cash equivalents   $ 84,067     $ 57,466    
Investments     63,992       39,363    
Prepaid expenses and other current assets     6,347       5,764    
Total current assets     154,406       102,593    
Operating lease right-of-use asset     1,612       1,712    
Security deposits and leasehold improvements     201       201    
TOTAL ASSETS   $ 156,219     $ 104,506    
LIABILITIES AND STOCKHOLDERS’ EQUITY               
CURRENT LIABILITIES:               
Current portion of operating lease liabilities   $ 415     $ 406    
Accounts payable     3,475       640    
Accrued expenses and other current liabilities     15,884       20,189    
Total current liabilities     19,774       21,235    
NONCURRENT LIABILITIES:              
Noncurrent portion of operating lease liabilities     1,224       1,332    
Total noncurrent liabilities     1,224       1,332    
Total liabilities     20,998       22,567    
STOCKHOLDERS’ EQUITY:                
Common stock, $0.0001 par value; 100,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 26,010,465 shares and 22,493,661 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively     3       2    
Additional paid-in capital     320,282       242,780    
Accumulated other comprehensive loss     (154 )     (112 )  
Accumulated deficit     (184,910 )     (160,731 )  
Total stockholders’ equity     135,221       81,939    
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY   $ 156,219     $ 104,506    
                   



Tap to Ride! Monterey-Salinas Transit Becomes 1st in California to Offer Riders the Ability to Tap to Pay with Visa

Tap to Ride! Monterey-Salinas Transit Becomes 1st in California to Offer Riders the Ability to Tap to Pay with Visa

As part of a statewide initiative to improve and simplify the transit experience, riders who tap to pay will be guaranteed best fares for the trips they take

SAN FRANCISCO–(BUSINESS WIRE)–
Today, in collaboration with Visa, Caltrans, Cybersource, Littlepay, and SC Soft, Monterey-Salinas Transit (MST) became the first transit agency in California to offer bus riders a contactless payment option. As cities begin to reopen, public transportation will play a critical role in recovery, and contactless payments can help provide a safe and easy experience for riders and transit operators seeking limited physical touchpoints and interactions. MST riders can now simply tap their contactless credit, debit, prepaid card or payment-enabled device on readers in MST buses for an easy and secure way to travel, without needing to purchase or load a separate transit card or handle cash while boarding.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210511005504/en/

(Graphic: Business Wire)

(Graphic: Business Wire)

Visa research shows that enabling tap to pay on transit systems like these can be good for economic recovery, bringing more than a 15% lift in transactions from merchants in surrounding neighborhoods1. MST is the fifth transit agency in the U.S. to accept tap to pay for fares, following Chicago, Miami, New York and Portland, OR. MST is also the first public transit system in the country that is located outside of a large urban area to introduce tap to pay fares – demonstrating contactless payments as a good fit for any size agency looking to enhance the customer experience.

“Visa recognizes the importance of expanding eligibility and access to fare payment options that meet the needs of a diverse set of transit riders,” said Brian Cole, SVP and head of North America product, Visa. “This effort with MST and Caltrans illustrates how open, contactless payments can support innovative and equitable fare policies to benefit riders and transit operators across the state.”

MST riders who tap will benefit from “fare capping” ensuring riders won’t pay more than $10.00 per day—as long as they pay with the same card or mobile wallet throughout the day. The tap to pay option on MST’s entire bus fleet is the first contactless payment demonstration of the California Integrated Travel Project (Cal-ITP), a Caltrans-led initiative to make travel simpler and more cost-effective for the 40 million California residents, served by 300-plus transit agencies, who collectively take approximately 1.3 billion2 passenger trips annually.

“We are committed to serving all of our riders and delivering new methods of ease and convenience,” said Carl Sedoryk, general manager and CEO, Monterey-Salinas Transit. “The availability of a contactless fare payment system means increased flexibility, and we are thrilled to be collaborating with Visa and Caltrans to bring the enhanced convenience and safety benefits of tap to pay to our community.”

Bringing the MST Demonstration to Life

Cybersource, a Visa solution, Littlepay, a transit-focused payments platform, and SC Soft, a transit ticketing and Automated Fare Collection specialist, have been critical in bringing the MST demonstration to life. Cybersource’s platform is powering the fast-to-market deployment of contactless solutions in the mass transit space, providing a full suite of payment and fraud management tools and an extensive network of partners and acquirers. Cybersource offers brand agnostic transit compliant processing solutions and enables easier implementation of digital payments for operators, while helping protect against fraud. Littlepay provides mass transit transaction processing, including the ability to cap fares and guarantee the best-value fare for frequent riders. SC Soft is a system integrator specializing in ticketing & Automated Fare Collection solutions for transit agencies around the world.

“Cybersource looks forward to supporting Cal-ITP partners to improve transit access within communities throughout the state,” said Fernando Souza, Vice President, Cybersource. “There is a great sense of urgency among transit operators to adopt these solutions and we are committed to powering secure, seamless contactless solutions in a world where no contact, touchless experiences are here to stay.”

“Removing barriers to transit ridership underscores what Cal-ITP is all about, and the launch of this contactless payment demonstration represents a significant step toward a simpler and more equitable public transit system throughout California,” said Caltrans Director Toks Omishakin.

Adoption of contactless payments continues to grow in the U.S. as more consumers realize they can pay for the things they need with a simple and secure tap. In the US, one in 10 face to face Visa transactions are now done with a tap, more than a 2x increase since the beginning of the pandemic, showcasing increased consumer preference for fast, touch-free payment experiences.

About Visa Inc.

Visa Inc. (NYSE: V) is the world’s leader in digital payments. Our mission is to connect the world through the most innovative, reliable, and secure payment network – enabling individuals, businesses and economies to thrive. Our advanced global processing network, VisaNet, provides secure and reliable payments around the world and is capable of handling more than 65,000 transaction messages a second. The company’s relentless focus on innovation is a catalyst for the rapid growth of connected commerce on any device, and a driving force behind the dream of a cashless future for everyone, everywhere. As the world moves from analog to digital, Visa is applying our brand, products, people, network and scale to reshape the future of commerce. For more information, visit About Visa, Visa’s Blog and @VisaNews.

__________

1Visa Q2 FY21 Earnings Transcript

2Caltrans, FY2018-2019

Visa

Tierney Deggelman

650 418 0352

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Public Transport Mobile/Wireless Technology Security Transport Software Networks Internet Hardware Data Management

MEDIA:

Photo
Photo
(Graphic: Business Wire)

Achilles Therapeutics Reports First Quarter 2021 Financial Results and Recent Business Highlights

– Reported first clinical data from the CHIRON and THETIS trials and received recommendation from the Independent Data Safety Monitoring Committee to continue trials as planned –

– Completed initial public offering of ADSs raising $175.5 million in gross proceeds –        

LONDON, May 11, 2021 (GLOBE NEWSWIRE) — Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, today announced its financial results for the first quarter ended March 31, 2021 and recent business highlights.

“Achilles made significant progress in the first quarter of 2021. We reported the first clinical data from our ongoing CHIRON and THETIS trials evaluating our precision TIL cNeT therapy in patients with non-small cell lung cancer and melanoma, respectively, and priced our successful US initial public offering on Nasdaq, which closed just after quarter-end,” said Dr Iraj Ali, Chief Executive Officer of Achilles. “We continue to enroll and dose patients and have opened our first clinical sites in the US and EU. This year, we expect to report interim data from a total of ten patients that have received cNeT monotherapy across the CHIRON and THETIS trials and will also begin enrolling patients to receive higher dose cNeT. In addition, we will open Cohort B in the THETIS study to evaluate the addition of a PD-1 inhibitor to our cNeT therapy.”

Business Highlights

  • Received a recommendation from the Independent Data Safety Monitoring Committee to continue the ongoing Phase I/IIa CHIRON and THETIS trials as planned
  • Announced initial clinical data from the first six patients dosed with the Company’s cNeT therapy showing encouraging evidence of cNeT engraftment, an overall tolerability profile similar to that of standard TIL products, stable disease in four out of the six patients, and one patient with tumor lesion reduction
  • Presented data at the American Association of Cancer Research (AACR) annual meeting detailing the Company’s comprehensive translational research program and insights into the in vivo dynamics of cNeT post-dosing, and the potential to develop a potency-based release assay
  • Strengthened the Board of Directors and Scientific Advisory Board with the additions of Julie O’Neill and Markwin Velders, Ph.D., respectively, and continued to build the team in the UK & US, including key appointments across manufacturing, supply chain and clinical operations, bio-processing and intellectual property
  • Received a Horizon 2020 grant as part of the Neoantigen Consortium, with the aim of developing a tool to predict neoantigen immunogenicity.

Financial Highlights

  • IPO: Priced an initial public offering of 9,750,000 ADRs at a public offering price of $18.00 per share for gross proceeds of $175.5 million. The IPO closed on April 6, 2021, after the quarter end.
  • Cash and cash equivalents: Cash and cash equivalents were $159.3 million as of March 31, 2021 as compared to $177.8 million as of December 31, 2020, not including $160.6 million in net proceeds from the IPO which closed on April 6, 2021. The Company anticipates that its existing cash and cash equivalents plus the IPO proceeds are sufficient to fund its planned operations into the second half of 2023, including full funding of the ongoing Phase I/IIa CHIRON and THETIS clinical trials.
  • Operating Expenses: Operating Expenses were $13.7 million for the quarter ended March 31, 2021, which included $8.9 million in Research & Development, and General and Administrative expenses of $4.8 million.
  • Net loss: Net loss attributable to ordinary shareholders was $13.8 million for the quarter ended March 31, 2021 and the basic and diluted net loss per ordinary share was $8.38 for the quarter ended March 31, 2021.

Upcoming Events

  • Iraj Ali, Chief Executive Officer, will participate in a fireside chat at the BofA Securities 2021 Virtual Healthcare Conference at on Thursday, May 13, 2021, at 9:30 a.m. ET / 2:30 p.m. BST.
  • A poster detailing abstract TPS9138 entitled, An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Clonal Neoantigen Reactive T cells in Patients with Advanced Non-Small Cell Lung Cancer (CHIRON), will be presented at the 2021 ASCO Annual Meeting taking place virtually from June 4-9, 2021. Full abstracts will be released on May 19, 2021 at ASCO.org.

About Achilles Therapeutics

Achilles is a clinical-stage biopharmaceutical company developing precision T cell therapies targeting clonal neoantigens: protein markers unique to the individual that are expressed on the surface of every cancer cell. The Company has two ongoing Phase I/IIa trials, the CHIRON trial in patients with advanced non-small cell lung cancer (NSCLC) and the THETIS trial in patients with recurrent or metastatic melanoma. Achilles uses DNA sequencing data from each patient, together with its proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient, and then develop precision T cell-based product candidates specifically targeting those clonal neoantigens.

Forward-Looking Statements

This press release contains express or implied forward-looking statements that are based on our management’s belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

Further information:

Lee M. Stern – VP, IR & External Communications

+1 (332) 373-2634
[email protected]

Consilium Strategic Communications

Mary-Jane Elliott, Sukaina Virji, Melissa Gardiner
+44 (0) 203 709 5000
[email protected]

ACHILLES THERAPEUTICS PLC

Condensed Consolidated Balance
Sheets
(Unaudited)

(in thousands, except share and per share amounts)

(expressed in U.S. Dollars, unless otherwise stated)

    March 31,     December 31,  
    2021     2020  
ASSETS                
Current assets:                
Cash and cash equivalents   $ 159,262     $ 177,849  
Prepaid expenses and other current assets     14,058       9,948  
Total current assets     173,320       187,797  
Non-current assets:                
Property and equipment, net     15,479       13,369  
Operating lease right of use assets     14,155       14,740  
Deferred tax assets     4       4  
Other assets     3,145       3,008  
Total non-current assets     32,783       31,121  
TOTAL ASSETS   $ 206,103     $ 218,918  
LIABILITIES AND SHAREHOLDERS’ EQUITY                
Current liabilities:                
Accounts payable   $ 1,787     $ 6,314  
Income taxes payable     19       7  
Accrued expenses and other liabilities     8,646       6,590  
Operating lease liabilities-current     4,610       3,712  
Total current liabilities     15,062       16,623  
Non-current liabilities:                
Operating lease liabilities-non-current     11,329       12,271  
Other long-term liability     659       652  
Total non-current liabilities     11,988       12,923  
Total liabilities     27,050       29,546  
Commitments and contingencies (Note 11)                
Shareholders’ equity:                
Ordinary shares, £0.001 par value; 30,853,489 and 4,389,920 shares
authorized, issued and outstanding at March 31, 2021 and December
31, 2020, respectively
    6       6  
Deferred shares, £0.001 par value; 109,058 and 30,521 shares issued and
outstanding as of March 31, 2021 and December 31, 2020, respectively
           
Convertible preferred shares, £0.001 par value; no shares authorized,
issued and outstanding as of March 31, 2021;104,854,673 shares
authorized, issued and outstanding at December 31, 2020
    134       134  
Additional paid in capital     236,305       234,922  
Accumulated other comprehensive income     14,385       12,322  
Accumulated deficit     (71,777 )     (58,012 )
Total shareholders’ equity     179,053       189,372  
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY   $ 206,103     $ 218,918  
                 

ACHILLES THERAPEUTICS PLC

Condensed Consolidated Statements
of
Operations
and
Comprehensive
Loss
(Unaudited)

(in thousands, except share and per share amounts)

    Three Months Ended March 31,  
    2021     2020  
OPERATING EXPENSES:                
Research and development   $ 8,876     $ 3,830  
General and administrative     4,832       1,736  
Total operating expenses     13,708       5,566  
Loss from operations     (13,708 )     (5,566 )
OTHER INCOME (EXPENSE), NET:                
Other income (expense)     (45 )     352  
Total other income (expense), net     (45 )     352  
Loss before provision for income taxes     (13,753 )     (5,214 )
Provision for income taxes     (12 )      
Net loss     (13,765 )     (5,214 )
Other comprehensive income:                
Foreign exchange translation adjustment     2,063       (6,510 )
Comprehensive loss   $ (11,702 )   $ (11,724 )
Net loss per share attributable to ordinary shareholders—basic and diluted   $ (8.38 )   $ (6.13 )
Weighted average ordinary shares outstanding—basic and diluted     1,641,938       850,377  
                 



Intel Launches New 11th Gen Core for Mobile

Intel Launches New 11th Gen Core for Mobile

Intel delivers industry-leading mobile performance with 11th Gen Intel Core mobile H-series and Intel Xeon W-11000 series.

SANTA CLARA, Calif.–(BUSINESS WIRE)–What’s New: The new 11th Generation Intel® Core™ H-series mobile processors (code-named “Tiger Lake-H”) launched worldwide today, led by the flagship Intel® Core™ i9-11980HK — the “World’s Best Gaming Laptop Processor.”1 The Intel Core i9-11980HK delivers the highest-performance2 in laptops for gaming, content creators and business professionals reaching speeds of up to 5.0 gigahertz (GHz).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210511005460/en/

11th Gen Intel Core H-series mobile processors, based on 10nm SuperFin process technology and reaching speeds of up to 5.0GHz, deliver industry-leading mobile performance with up to eight cores and 16 threads -- and PCIe Gen 4 support, a first for any H-series laptop. The 11th Gen Intel Core H-series mobile processors (code-named "Tiger Lake-H") launched worldwide on May 11, 2021. (Credit: Intel Corporation)

11th Gen Intel Core H-series mobile processors, based on 10nm SuperFin process technology and reaching speeds of up to 5.0GHz, deliver industry-leading mobile performance with up to eight cores and 16 threads — and PCIe Gen 4 support, a first for any H-series laptop. The 11th Gen Intel Core H-series mobile processors (code-named “Tiger Lake-H”) launched worldwide on May 11, 2021. (Credit: Intel Corporation)

“11th Gen Intel Core H-series processors take mobile gaming, content creation and commercial workstation systems to new heights. These new H-series processors are an exciting extension of our 11th Gen mobile family with double-digit single core and multi-core performance improvements, leading gameplay, direct attached storage and 20 PCIe 4.0 lanes for true enthusiast-level platform bandwidth. 11th Gen H-series is the industry’s most performant mobile processor that empowers users to game, create and connect with leadership performance at any enthusiast form factor.”

–Chris Walker, Intel corporate vice president and general manager of the Mobile Client Platforms Group

About Desktop-Caliber Gaming Performance on Mobile: With new 11th Gen Intel Core H-series processors, Intel leverages deep expertise in advanced processor design and PC gaming to bring the world’s best gaming laptop processors1 to gamers around the globe.

Extending the performance momentum established by the 11th Gen Intel Core H35 series, the 11th Gen Intel H-series processors, based on 10 nanometer SuperFin process technology, feature up to 8 cores and 16 threads, with single and dual-core turbo performance up to 5.0GHz. Additionally, the central processing unit (CPU) can directly access high-speed GDDR6 memory attached to the graphics card, enabling gamers to experience higher framerates with lower latency, and load large textures faster. The mobile processor offers 2.5 times the total PCIe bandwidth to the CPU compared with the 10th Gen H-series processors, and three times the total PCIe bandwidth compared with other industry processors.

About This Bleeding-Edge Platform: 11th Gen Intel Core H-series mobile processors empower creators and business professionals to execute tasks faster, from anywhere, thanks to best-in-class components and connectivity 3. With 20 lanes of PCIe Gen 4 — a first for any laptop — the processor offers 4k HDR/Dolby Vision video streaming, rich configurations with fast storage, hybrid Intel® Optane™ storage for high performance and capacity, 6GHz Intel® Killer™ Wi-Fi 6E (Gig+) support, and Thunderbolt™ 4 with up to 40 gigabytes (GBs) per second for faster connections.

New platform features also include:

  • 20 PCIe Gen 4.0 lanes with Intel® Rapid Storage Technology bootable in Raid 0 — and up to 44 total PCIe lanes that include 24 PCIe Gen 3.0 lanes from a dedicated platform controller hub.
  • Memory support up to DDR4-3200.
  • Thunderbolt™ 4 with transfer speeds up to 40Gbps.
  • Discrete Intel® Killer™ Wi-Fi 6E (Gig+).
  • Dual Embedded Display Port integrated for power optimized companion display.

Today’s launch also introduces new Intel vPro® H-series processors — led by the eight-core and 16-thread Intel® Core™ i9-11950H — and Intel® Xeon® W-11000 series mobile processors. Built on the 11th Gen Intel vPro® platform, the unrivaled business-class PC platform delivers comprehensive hardware-based security4 and breakthrough performance, as well as powerful computing experiences for professional users such as engineers, data scientists, content creators and financial analysts who need to tackle multi-threaded, performance intensive applications at their desk, or on the go. The new 11th Gen Intel® Core™ vPro® H-series processors and Xeon W-11000 series mobile processors unveiled today and, when combined with the new Intel Core vPro platform, offer:

  • Xeon + Error Correcting Code (ECC) memory.
  • Intel® Hardware Shield​ — available exclusively on the Intel® vPro® platform, as delivered by 11th Gen Intel® Core™ vPro® mobile processors5, provides the world’s most comprehensive hardware-based security for business, and the industry’s first and only silicon-enabled artificial intelligence threat detection to help stop ransomware and cryptomining attacks for Windows-based systems.5 It is also equipped with Intel® Control-flow Enforcement Technology, a ground-breaking technology to help shut down an entire class of attacks that long evaded software-only solutions.6
  • Intel® Total Memory Encryption.
  • Intel® Active Management Technology.
  • Intel® Deep Learning Boost​.

About the Diversity of Designs with Broad Availability: 11th Gen Intel Core Mobile H-series and Intel® Xeon® W-11000 series processors will power more than 80 enthusiast laptop designs across consumer, commercial and workstation segments this year. With more than one million 11th Gen H-series processors shipped to Intel partners worldwide by launch, whether it’s for high-refresh gaming, robust content creation or mobile workstations, no one offers people more choices and availability when it comes to mobile computing.

More Context: 11th Gen Intel Core H-series Demos (Video) | Introducing 11th Gen Intel Core H-Series Processors (Product Brief) | 11th Gen Intel Core H-Series & Xeon Mobile Processors (Media Presentation) | The Unrivaled Intel vPro Platform (Platform Brief)

About Intel

Intel (Nasdaq: INTC) is an industry leader, creating world-changing technology that enables global progress and enriches lives. Inspired by Moore’s Law, we continuously work to advance the design and manufacturing of semiconductors to help address our customers’ greatest challenges. By embedding intelligence in the cloud, network, edge and every kind of computing device, we unleash the potential of data to transform business and society for the better. To learn more about Intel’s innovations, go to newsroom.intel.com and intel.com.

1 As measured by frames per second on similarly configured systems with 11th Gen Intel® Core™ i9-11980HK, Intel® Core™ i9-10980HK, or Ryzen 9 5900HX processors. Product prices may vary. Results: 11th Gen Intel® Core™ i9-11980HK scored higher on the majority of the 29 game titles tested. See www.intel.com/11thgenmobile for details.

2 Estimated based on Intel internal measurements of SPECint_rate_base2017 (1-copy) of an Intel® Core™ i9-11980HK-based internal reference platform versus estimated measurements on AMD Ryzen™ 9 5900HX, Intel® Core™ i9-10980HK and Intel® Core™ i7-11375H processors. See www.intel.com/11thgenmobile for details.

3 Subject to regional spectrum allocation; not available in all markets. Visit www.intel.com/PerformanceIndex (connectivity) for details.

4 Learn more at www.intel.com/11thgenvpro. No product or component can be absolutely secure.

5 In Windows-based PCs, based on unique features and IOActive testing (commissioned by Intel; as of April 2021) comparing Intel® Hardware Shield security capabilities with corresponding technologies in AMD Ryzen™ Pro-based systems. Visit www.intel.com/11thgenvpro for details. No product or component can be absolutely secure.Results may vary.

6 Intel® Control-flow Enforcement Technology (Intel® CET) is designed to help protect against jump/call-oriented programming (JOP/COP) attack methods and return-oriented programming (ROP) attack methods, malware known as memory safety issues and which comprise over half of ZDI-disclosed vulnerabilities. Visit www.intel.com/11thgenvpro for details. No product or component can be absolutely secure. Results may vary.

Additional Disclaimers:

Performance results are based on testing as of dates shown in configurations and may not reflect all publicly available updates. Performance varies by use, configuration and other factors. Learn more at www.Intel.com/PerformanceIndex.

Your costs and results may vary.

Certain features available on select SKUs only. Please check OEM website for specific device details.

Intel contributes to the development of benchmarks by participating in, sponsoring, and/or contributing technical support to various benchmarking groups, including the BenchmarkXPRT Development Community administered by Principled Technologies.

Intel technologies may require enabled hardware, software or service activation.

Altering clock frequency or voltage may void any product warranties and reduce stability, security, performance, and life of the processor and other components. Check with system and component manufacturers for details.

© Intel Corporation. Intel, the Intel logo and other Intel marks are trademarks of Intel Corporation or its subsidiaries. Other names and brands may be claimed as the property of others.

Andrew Evangelista

1-408-765-5022

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Software Networks Internet Hardware Data Management Consumer Electronics Technology Semiconductor

MEDIA:

Logo
Logo
Photo
Photo
11th Gen Intel Core H-series mobile processors, based on 10nm SuperFin process technology and reaching speeds of up to 5.0GHz, deliver industry-leading mobile performance with up to eight cores and 16 threads — and PCIe Gen 4 support, a first for any H-series laptop. The 11th Gen Intel Core H-series mobile processors (code-named “Tiger Lake-H”) launched worldwide on May 11, 2021. (Credit: Intel Corporation)
Photo
Photo
11th Gen Intel Core H-series mobile processors (code-named “Tiger Lake-H”) launched worldwide on May 11, 2021, led by the flagship Intel Core i9-11980HK. Based on 10nm SuperFin process technology and reaching speeds of up to 5.0GHz, the Intel Core i9-11980HK delivers the highest-performance in laptops for gaming, content creators and business professionals. (Credit: Intel Corporation)
Photo
Photo
11th Gen Intel Core H-series mobile processors, based on 10nm SuperFin process technology and reaching speeds of up to 5.0GHz, deliver industry-leading mobile performance with up to eight cores and 16 threads — and PCIe Gen 4 support, a first for any H-series laptop. The 11th Gen Intel Core H-series mobile processors (code-named “Tiger Lake-H”) launched worldwide on May 11, 2021. (Credit: Intel Corporation)

REPEAT – Minera Salar Blanco, Agrees Strategic Alliance with Mitsui for the Development of Maricunga and Future Developments in Chile

VANCOUVER, British Columbia, May 11, 2021 (GLOBE NEWSWIRE) — Bearing Lithium Corp. (“Bearing” or the “Company”) (TSX Venture: BRZ) (OTCQB:BLILF) is pleased to provide an update as announced by Minera Salar Blanco (“MSB”).

__________________________________________________________________________________        

The Alliance includes off-take, funding rights and further strategic collaboration for new lithium developments in Chile.

_______________________________________________________________________________                

MSB is pleased to announce that it has entered into a non-binding Memorandum of Understanding (the “MOU”) with the Japanese conglomerate Mitsui & Co., Ltd., (“Mitsui”) to set up a strategic alliance to advance the development of the Maricunga project (the “Project”).

The MOU intends to create a partnership of the Project. The MOU also addresses the development of the Chilean lithium industry, by partnering to introduce other leading edge efficient and environmentally friendly technologies for processing.

The strategic alliance includes potential off-take and funding rights for the Stage One of the Project; potential participation, off-take and funding rights for future expansions of the Project, and further strategic collaboration for new developments in Chile, based on new technology related to direct lithium extraction (the “DLE”) currently being studied and tested.

In particular, the parties aim to achieve the following goals as a result of such strategic alliance:

  • Off-Take Rights – Mitsui will have the right to purchase up to 15,000 tonnes annually of high purity lithium carbonate battery grade production from the Stage One of the Project for 10 years, extendable for 2 consecutive 5 years periods. The parties will agree on a price structure and terms of the off-take in a later stage, in order to be sufficiently bankable to support’s MSB’s debt funding requirements.

    The parties will leverage Mitsui’s considerable global logistics and battery materials marketing expertise on the distribution of the products.

  • Right to Participate in Funding of Maricunga’s Stage One – Mitsui will have the right to participate directly in the funding of the Stage One of the Project. The parties will consider an optimized funding structure through a combination of equity-like and debt-like options.

  • Participation in Future Expansions, Off-Take and Funding Rights – Subject to the parties agreeing to a financing proposal where Mitsui provides a relevant portion of the necessary funding of the capital expenditures required for the future expansion of the Project, Mitsui will have the first option for an off-take agreement to purchase a relevant portion of the future production of the expansion.

    MSB will use its best efforts to utilize new technology related to the DLE currently being studied and tested by Mitsui’s technical partners.

  • Further Strategic Collaboration – MSB will collaborate with Mitsui for the development of other lithium related businesses in the country by introducing efficient and environmentally friendly processing technologies. In this context, MSB will commit to collaborate with Mitsui and its technical partner to facilitate the development and testing of the DLE technology at the Maricunga Salar, and provide a broader platform for the promotion of this technology.

Terms and details of the definitive agreements will be finalised after completion of all necessary due diligence and transaction structuring and subject to each party’s internal approval.

Minera Salar Blanco’s Chief Executive Officer, Cristobal Garcia-Huidobro, commented:

“We are incredibly pleased to have reached a mutually beneficial MOU with Mitsui. The MOU is comprehensive, and it sets a framework for the Stage One of the Project development to proceed with the backing of a world-renowned partner. We look forward to finalising the definitive agreements with Mitsui and working with them on mutually beneficial lithium projects and positive outcomes for the Chilean lithium industry.


About Minera Salar Blanco (MSB)

MSB is the owner of a lithium and potash project in Chile’s III Region, at the Maricunga Salar, which is in a very advance stage of development, having received its environmental approval on February 4th, 2020 by the Chilean authorities (Resolution #94) and with its definitive feasibility study released in January 2019, now being updated. The Project is in its first stage denominated the “Stage One” with a nameplate capacity of 15,000 annual tonnes of high purity lithium carbonate (the “Products”) over a 20-year mine life. It also provides significant future expansion potential from subsequent stages to be developed over the other part of the mining concessions owned by MSB.


About Mitsui & Co. Ltd

Mitsui & Co., Ltd (8031: JP) is a global trading and investment company with a diversified business portfolio that spans approximately 64 countries in Asia, Europe, North, Central & South America, The Middle East, Africa and Oceania.

Mitsui has over 5,600 employees and deploys talent around the globe to identify, develop, and grow businesses in collaboration with a global network of trusted partners. Mitsui has built a strong and diverse core business portfolio covering the Mineral and Metal Resources, Energy, Machinery and Infrastructure, and Chemicals industries.

About Bearing Lithium Corp.

Bearing Lithium Corp. is a lithium-focused mineral exploration and development company. Its primary asset is a 17.35% interest in the Maricunga Lithium Brine Project in Chile. The Maricunga Project represents one of the highest-grade lithium brine salars globally and the only pre-production project in Chile. Over $US 60 million has been invested in the Maricunga Project. All Project Expenditures through to the delivery of a Definitive Feasibility Study in January 2019 have been fully funded by the 51% earn-in joint-venture partner, Lithium Power International.

ON BEHALF OF THE BEARING LITHIUM BOARD


Signed “Gil Playford”


Gil Playford, Chairman
[email protected]

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.


Cautionary Statements Regarding Forward Looking Information

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward-looking statements.

Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved.. Actual future results may differ materially. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors, both known and unknown, could cause actual results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements and the parties have made assumptions and estimates based on or related to many of these factors. Readers should not place undue reliance on the forward-looking statements and information contained in this news release concerning these times. Except as required by law, the Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.



OncoResponse Appoints Chris Russell as Chief Financial Officer

SEATTLE, May 11, 2021 (GLOBE NEWSWIRE) — OncoResponse, a biotechnology company harnessing the power of the human immune system to identify and develop novel monoclonal antibodies to immunosuppressive myeloid targets for cancer immunotherapy, today announced the appointment of Chris Russell as Chief Financial Officer. Mr. Russell previously served as financial advisor to OncoResponse and now joins the Company’s senior leadership.

“We are thrilled to have Chris join our strong team to help us oversee our path to IPO and the public markets,” said Clifford Stocks, Chief Executive Officer of OncoResponse. “Chris has a diverse background with experience across several functions. He will be a great asset to our company as we expand and advance our pipeline of cancer immunotherapies into the clinic.”

Mr. Russell brings to OncoResponse over 30 years of experience as a growth company executive and entrepreneur. He served as President of Oracle Corp.’s online division, where he launched their on-demand offerings, now a multi-billion-dollar business. Mr. Russell has also helped lead and grow numerous successful new companies and products. He was on the team who conceived and funded ArcSight, which completed a successful IPO and was acquired by HP for $1.5 billion. He led product and marketing at WageWorks, who completed an IPO and was later acquired by HealthEquity for $2 billion. As founding COO, he helped fund and grow TrustArc, the leader in internet data privacy. Earlier in his career, Mr. Russell was a strategy consultant at Booz Allen and an auditor and CPA at both EY and PwC.

Mr. Russell holds a degree in Accounting from the University of Washington and an M.B.A with honors from the University of Chicago, Booth Graduate School of Business.

“I’m pleased to join OncoResponse at this exciting point in their growth,” said Mr. Russell. “The Company has developed important insights into new ways to combat cancer and is now advancing those discoveries into clinical therapies with wonderful potential to improve the lives of patients and their families. I am delighted to join their talented team and contribute to the financial and operational performance of the Company.”

ABOUT ONCORESPONSE

OncoResponse, Inc., an immuno-oncology focused biotech company, in a broad strategic alliance with MD Anderson Cancer Center uses a proprietary B-cell technology platform to mine the immune system of cancer patients who have responded to cancer immunotherapy to discover novel targets and antibodies, and develop therapeutic monoclonal antibodies to treat cancer.  OncoResponse has several antibodies directed at modulating immunosuppression of the tumor microenvironment in pre-clinical development and a CD163 targeting antibody entering clinical studies summer 2021.  OncoResponse, Inc. is a privately held company backed by investment from MD Anderson Cancer Center, Rivervest Venture Partners, Redmile Group, Magnetar Group, Yonjin Venture, Bering Capital, ARCH Venture Partners, Helsinn Investment Fund, Canaan Partners, GreatPoint Ventures, Takeda Ventures, Buchang Pharma, Alexandria Real Estate Equities and William Marsh Rice University.  For more information please visit:  www.oncoresponseinc.com

INVESTOR CONTACT:

John Graziano
Solebury Trout
+1 646-378-2942
[email protected]



Taysha Gene Therapies Reports First Quarter 2021 Financial Results and Provides a Corporate Update

Taysha Gene Therapies Reports First Quarter 2021 Financial Results and Provides a Corporate Update

TSHA-120 program demonstrated clear arrest of disease progression and long-term durability at therapeutic dose levels in patients with giant axonal neuropathy (GAN); Expects clinical data from highest dose cohort in second half of 2021 and regulatory feedback from agencies by year-end 2021

Expects to have five programs in Phase 1/2 trials in the second half of 2021, including GAN, GM2 gangliosidosis, CLN1 disease, Rett syndrome and SURF1-associated Leigh syndrome

Positive preclinical data for TSHA-102 in Rett syndrome provided quantitative evidence of miRARE’s ability to exhibit genotype-dependent regulation of MECP2 gene expression across different brain regions in both wild type and knockout mouse models of Rett syndrome; Results published in Brain

Treatment with TSHA-102 resulted in a statistically significant survival extension by 56% in 4-5 week-old knockout Rett mice with meaningful accumulated disease, a more translatable model of the disorder in humans

New data for multiple preclinical programs, including tauopathies, SLC13A5 deficiency, SLC6A1 haploinsufficiency, Angelman disease, Adult Polyglucosan Body Disease (APBD), Lafora disease, and GM2 AB variant, highlighted Taysha’s next wave of novel gene therapies that have the potential to impact meaningful patient populations

Plans for IND/CTA submission from one of the following programs by year-end 2021: SLC13A5 deficiency, APBD, Lafora disease, GM2 AB variant and SLC6A1 haploinsufficiency

Advancing development of multiple preclinical programs, including tauopathies and Angelman syndrome

Virtual Research and Development Day on June 28-29, 2021 to feature Key Opinion Leaders and highlight progress across pipeline

Conference call and webcast today at 8:00 AM Eastern Time

DALLAS–(BUSINESS WIRE)–
Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric, pivotal-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS) in both rare and large patient populations, today reported financial results for the first quarter ended March 31, 2021 and provided a corporate update.

“Our team has ushered in the new year with a continued focus on achieving our corporate objectives and creating value for patients and shareholders,” said RA Session II, President, Founder and CEO of Taysha. “Our recent acquisition of TSHA-120 for GAN immediately transformed Taysha into a pivotal-stage gene therapy company. Based on the compelling clinical and preclinical data package generated to date for this promising product candidate, we intend to engage with regulatory agencies to discuss a pathway to approval and look forward to providing clinical and regulatory updates in the second half of 2021 and by year-end 2021, respectively. We are also extremely pleased to share newly published preclinical data for TSHA-102 in Rett syndrome that provided, for the first time, quantitative evidence of miRARE’s ability to show genotype-dependent regulation of MECP2 gene expression across different regions of the brain in wild type and knockout mouse models. Rett syndrome is an incredibly difficult disease to treat with gene replacement therapy given the challenges of safely regulating the degree of MECP2 expression from the MECP2 gene and we are encouraged that miRARE has achieved this regulation on a cell-by-cell basis without associated toxicities. The built-in self-regulatory feedback loop mechanism is a culmination of approximately 14 years of research and holds great potential for the treatment of what we now consider a reversible disease. Importantly, TSHA-102-treated knockout Rett mice with meaningful disease accumulation experienced a statistically significant survival extension by 56%, which we believe is a more translatable model of the disorder in humans. We believe these data validate our novel approach to treating Rett syndrome, help de-risk the clinical program and support advancement of TSHA-102 into a Phase 1/2 trial by year-end. With these and other recent value-creating achievements, we are even more confident in our outlook for the full year.”

Suyash Prasad, MBBS, M.Sc., MRCP, MRCPCH, FFPM, Chief Medical Officer and Head of Research and Development of Taysha, said, “We expect a steady flow of near-term clinical, regulatory and preclinical catalysts for the remainder of 2021. We anticipate having five programs in Phase 1/2 trials and an additional six programs in IND/CTA-enabling studies by year-end 2021. For the remainder of 2021, we expect data from the highest dose cohort from the ongoing TSHA-120 trial for GAN, a regulatory update on the GAN program, first-in-human Phase 1/2 clinical data from the Queen’s University trial of TSHA-101 in GM2 gangliosidosis and the initiation of Phase 1/2 trials in GM2 gangliosidosis in the U.S., CLN1 disease, Rett syndrome and SURF1-associated Leigh syndrome. For our preclinical programs, we expect to submit an IND/CTA for one of six programs in IND/CTA-enabling studies by year-end 2021. Moreover, we will continue to make advancements on payload design and on the miRARE, mini-gene and vagus nerve redosing platforms, which are expected to drive further innovation. We look forward to providing additional updates at our two-day R&D Day event in June and throughout the year.”

Recent Corporate Highlights

  • Published new preclinical data for TSHA-102 in Rett syndrome in Brain journal

    • Preclinical data provided quantitative evidence of miRARE’s ability to exhibit genotype-dependent regulation of MECP2 gene expression across different brain regions in both wild type and knockout mouse models of Rett syndrome
    • TSHA-102 resulted in a statistically significant survival extension by 56%, whereas unregulated constructs did not extend survival significantly in the validated MECP2 knockout Rett mouse model
    • Benefit in 4-5 week-old TSHA-102-treated knockout Rett mice with meaningful accumulated disease should be a more translatable model to humans
    • In the pons and midbrain, miRARE inhibited mean expression in a genotype-dependent manner, as indicated by significantly fewer myc(+) cells observed in wild type mice than knockout mice (p<0.05), thereby demonstrating MECP2 levels within normal physiological parameters
    • These quantitative data, for the first time, demonstrated miRARE’s ability to regulate gene expression on a cell-by-cell basis, highlighting its potential application in numerous diseases that require controlled gene expression
  • Acquired exclusive worldwide rights to TSHA-120, a clinical-stage AAV9 gene therapy program for the treatment of GAN

    • Human proof-of-concept data for TSHA-120 demonstrated clear arrest of disease progression and long-term durability at therapeutic dose levels in patients with GAN
    • To date, 14 patients have been dosed with one of four dose levels of TSHA-120. TSHA-120 has demonstrated a dose-response relationship with arrest of disease progression at the second-highest dose level (1.8×1014 total vector genomes [vg]) at one-year post-treatment, affecting a statistically significant 8-point improvement on the MFM32 score
    • Six of these patients treated at therapeutic dose levels have shown sustained dose-dependent improvements in MFM32 scores for more than three years
    • Bayesian analyses confirmed nearly 100% probability of clinically meaningful slowing of disease in patients dosed at 1.8×1014 total vg compared to natural history
    • Long-term results demonstrated that treatment with TSHA-120 at multiple dose levels was well-tolerated with no severe drug-related adverse events
  • Reported new preclinical data for TSHA-113 for tauopathies, TSHA-105 for SLC13A5 deficiency, TSHA-103 for SLC6A1 haploinsufficiency, TSHA-106 for Angelman syndrome, TSHA-112 for APBD, TSHA-111-LAFORIN and TSHA-111-MALIN for Lafora disease, and TSHA-119 for GM2 AB variant that support advancement into clinical testing

    • TSHA-113 significantly reduced tau mRNA and protein levels in mouse models of human tauopathies via cerebral spinal fluid (CSF) delivery
    • TSHA-105 significantly reduced plasma citrate levels, normalized EEG brain activity, and reduced the number of seizures and seizure susceptibility in SLC13A5 knockout mice
    • TSHA-103 improved nesting and EEG activity in the SLC6A1 knockout mouse model and reduced spike train activity in SLC6A1 knockout and heterozygous mouse models
    • TSHA-106 increased UBE3A expression through shRNA-mediated knockdown of UBE3A-ATS in in vitro cell lines across 26 distinct shRNA candidates for the treatment of Angelman disease
    • TSHA-112 generated significant reductions in GYS1 protein, abnormal glycogen accumulation and polyglucosan bodies in the APBD knockout mouse model
    • TSHA-111-LAFORIN and TSHA-111-MALIN achieved effective knockdown of GYS1 expression and insoluble glycogen and decreased Lafora body formation in laforin and malin mouse models
    • TSHA-119 caused a dose-dependent reduction of GM2 accumulation at 20 weeks in GM2A knockout mice
  • Announced presentations of preclinical data for TSHA-104 in SURF1-associated Leigh syndrome and TSHA-105 in SLC13A5 deficiency at the 24th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT)

    • TSHA-104 increased COX1 activity in brain and muscle and restored elevation of blood lactate on exhaustive exercise in a dose-dependent manner in SURF1 knockout mice
    • TSHA-105 significantly reduced plasma citrate levels, normalized EEG brain activity, and reduced the number of seizures and seizure susceptibility in SLC13A5 knockout mice
  • Initiated construction of its internal 187,000-square-foot current Good Manufacturing Practices (cGMP) manufacturing facility in Durham, North Carolina, that will include multiple production suites designed to have a total capacity of 2,000 liters for preclinical, clinical, and commercial production of Taysha’s gene therapy pipeline; facility will include development, analytical, manufacturing and quality control testing capability for its broad portfolio of gene therapies
  • Established collaboration with Yale University, a key addition to partnerships with Cleveland Clinic and UTSW, to advance next-generation mini-gene payloads for AAV gene therapies for the treatment of genetic epilepsies and neurodevelopmental disorders
  • Grew company from 80 to approximately 120 employees between February and April 2021
  • Announced a two-day virtual R&D Day on June 28th and June 29th to feature Key Opinion Leaders and highlight progress across the pipeline

First Quarter 2021 Financial Highlights

Research and Development (R&D) Expenses: R&D expenses were $23.9 million for the first quarter ended March 31, 2021, compared to $5.5 million for the first quarter ended March 31, 2020. The increase was primarily related to the company’s development programs, as a result of increased manufacturing-related spend, clinical and preclinical activities, and headcount.

General and Administrative (G&A) Expenses: G&A expenses were $8.2 million for the first quarter ended March 31, 2021, compared to less than $0.1 million for the first quarter ended March 31, 2020. The increase was primarily due to an increase in personnel costs resulting from increased headcount, professional services fees, and other corporate-related expenses.

Net loss: Net loss for the first quarter ended March 31, 2021 was $32.0 million, or $0.87 per share, as compared to a net loss of $5.4 million, or $0.50 per share, for the first quarter ended March 31, 2020.

Cash and cash equivalents: As of March 31, 2021, Taysha had $228.7 million in cash and cash equivalents, which is expected to support planned operations into 2023.

Anticipated Milestones by Program

TSHA-120 for giant axonal neuropathy (GAN): an intrathecally dosed AAV9 gene therapy currently being evaluated in a clinical trial for the treatment of GAN, a rare inherited genetic disorder that affects both the central and peripheral nervous systems and is caused by loss-of-function mutations in the gene coding for gigaxonin

  • Report clinical data for TSHA-120 from the 3.5×1014 total vg dose cohort in the second half of 2021
  • Engage with major regulatory agencies to discuss the approval pathway and provide a regulatory update by year-end 2021

TSHA-101 for GM2 gangliosidosis: the first bicistronic gene therapy in clinical development designed to deliver two genes – HEXA and HEXB, comprising the alpha and beta sub-units of Beta Hexoseaminidase A, intrathecally for the treatment of GM2 gangliosidosis, also called Tay-Sachs or Sandhoff disease

  • Report preliminary Phase 1/2 safety and biomarker data (Queen’s University trial) in the second half of 2021
  • Submit an Investigational New Drug (IND) application in the U.S. in the second half of 2021
  • Initiate Phase 1/2 clinical trial in the U.S. in the second half of 2021

TSHA-118 in CLN1: a self-complementary AAV9 viral vector designed to express a human codon-optimized CLN1 transgene to potentially treat CLN1, a rapidly progressing rare lysosomal storage disease with no approved treatments

  • Maintain current open IND
  • Initiate a Phase 1/2 clinical trial in the second half of 2021
  • Report biomarker data in the first half of 2022

TSHA-102 in Rett syndrome: a self-complementary AAV9 gene therapy in development for a severe neurodevelopmental disorder, designed to deliver MECP2, as well as a novel miRARE platform that regulates transgene expression on a cell-by-cell basis

  • Submit IND/CTA filing in the second half of 2021
  • Initiate Phase 1/2 clinical trial by year-end 2021
  • Report clinical data by year-end 2022

TSHA-104 in SURF1-associated Leigh syndrome: a self-complementary AAV9 viral vector with a transgene encoding the human SURF1 protein to potentially treat SURF1-associated Leigh syndrome, a monogenic mitochondrial disorder with no approved treatments

  • Submit IND/CTA filing in the second half of 2021
  • Initiate Phase 1/2 trial by year-end 2021
  • Report biomarker data in the first half of 2022

Pipeline programs in IND/CTA-enabling studies

  • Submit an IND/CTA filing for one of six programs in 2021: TSHA-105 in SLC13A5 deficiency, TSHA-111-LAFORIN and TSHA-111-MALIN in two forms of Lafora disease, TSHA-112 in APBD, TSHA-119 in GM2 AB variant and TSHA-103 in SLC6A1 haploinsufficiency disorder

Discovery programs

  • Advance four new undisclosed programs focused on neurodevelopmental disorders, genetic epilepsies and neurodegenerative diseases into preclinical development in 2021

Next-generation technology platform

  • Continue development efforts focused on regulated transgene expression with expansion of miRARE platform into additional CNS diseases
  • Initiate confirmatory preclinical studies for the vagus nerve redosing platform in canines
  • Advance mini-gene discovery program in genetic forms of epilepsy and neurodevelopmental disorders
  • Continue discovery and development efforts around next-generation capsids

Anticipated Corporate Milestones in 2021

  • Continue construction of internal cGMP facility in 2021
  • Complete buildout of Dallas headquarters in Q2 2021
  • Expand employee base from approximately 120 (as of April 30, 2021) to approximately 150 by year-end 2021

Conference Call and Webcast Information

Taysha management will hold a conference call and webcast today at 8:00 am ET / 7:00 am CT to review its financial and operating results and to provide a corporate update. The dial-in number for the conference call is 855-327-6837 (U.S./Canada) or 631-891-4304 (international). The conference ID for all callers is 10014460. The live webcast and replay may be accessed by visiting Taysha’s website at https://ir.tayshagtx.com/news-events/events-presentations. An archived version of the webcast will be available on the website for 30 days.

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our team’s proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platform—an engine for potential new cures—with a goal of dramatically improving patients’ lives. More information is available at www.tayshagtx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning the potential of our product candidates, including our preclinical product candidates, to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed, the potential market opportunity for these product candidates, our corporate growth plans and our plans to establish a commercial-scale cGMP manufacturing facility to provide preclinical, clinical and commercial supply. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission (“SEC”) filings, including in our Annual Report on Form 10-K for the full-year ended December 31, 2020, which is available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

Taysha Gene Therapies, Inc.

Consolidated Statements of Operations

(in thousands, except share and per share data)

(Unaudited)

 

 

 

 

 

 

 

For the Three Months

Ended March 31, 2021

 

For the Three Months

Ended March 31, 2020

Operating expenses:
Research and development

$

23,854

 

$

5,514

 

General and administrative

 

8,236

 

 

70

 

Total operating expenses

 

32,090

 

 

5,584

 

Loss from operations

 

(32,090

)

 

(5,584

)

Other income (expense):
Change in fair value of preferred stock tranche liability

 

 

 

180

 

Interest income

 

66

 

 

 

Interest expense

 

 

 

(27

)

Total other income, net

 

66

 

 

153

 

Net loss

$

(32,024

)

$

(5,431

)

Net loss per common share, basic and diluted

$

(0.87

)

$

(0.50

)

Weighted average common shares outstanding, basic and diluted

 

36,992,377

 

 

10,894,999

 

 

Taysha Gene Therapies, Inc.

Consolidated Balance Sheet Data

(in thousands)

(Unaudited)

 

 

 

 

 

 

 

March 31,

 

December 31,

 

 

2021

 

2020

Cash and cash equivalents

$

228,684

$

251,253

Total assets

$

242,829

$

258,881

Total liabilities

$

19,957

$

7,579

Total stockholders’ equity

$

222,872

$

251,302

 

Company Contact:

Kimberly Lee, D.O.

SVP, Corporate Communications and Investor Relations

Taysha Gene Therapies

[email protected]

Media Contact:

Carolyn Hawley

Canale Communications

[email protected]

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: Biotechnology Health Genetics Pharmaceutical Clinical Trials

MEDIA:

Logo
Logo

The Hillman Group Announces Record First Quarter 2021 Results

CINCINNATI, May 11, 2021 (GLOBE NEWSWIRE) — The Hillman Companies, Inc. (NYSE-AMEX: HLM.PR) (the “Company” or “Hillman”) reported today record financial results for the first quarter ended March 27, 2021.

First Quarter 2021 Results

  • Strong net sales growth of 15.4% to $341.3 million as compared to prior year quarter net sales of $295.8 million
  • Net loss was $9.0 million compared to a prior year quarter net loss of $14.8 million
  • Adjusted EBITDA1 increased 15.2% to $47.8 million compared to $41.5 million in the prior year quarter

Doug Cahill, Chairman and Chief Executive Officer, stated “We are very pleased with our first quarter performance, with double-digit sales and profit growth reflecting the strong demand for hardware and home improvement products. This performance demonstrates the strength of the Hillman operating model and all-around exceptional execution by our in-store sales and service and supply chain teams that truly differentiates us in the market place.”

Mr. Cahill continued, “Looking ahead, we are encouraged by the continued strong trends we are seeing at our retail partners in our flagship Hardware Solutions business driven by sustained high levels of repair and remodel activity in the US and Canada. Likewise, we are pleased to see our high margin Robotics and Digital Solutions business quickly rebounding to pre-pandemic levels. Thankfully for all, vaccines have rolled out more quickly and the pandemic has receded faster than anticipated. In turn, demand in Protective Solutions has returned to normalized pre-pandemic levels sooner than expected and we are working together with our retail partners to transition away from pandemic specific PPE products. Fortunately, the remainder of our businesses is running ahead of our expectations and we are optimistic that this will endure. We will continue to focus on driving growth and investing both organically and through accretive M&A for long-term profitable growth and value creation.”

(1) Adjusted EBITDA is a non-GAAP financial measure. Refer to the “Non-GAAP Financial Measures” section of this press release for additional information as well as reconciliations between the company’s GAAP and non-GAAP financial results.

Liquidity and Capital Resources
At the end of the first quarter 2021, the Company had $13.9 million of cash and had $1,594.9 million of total debt outstanding, and $104.1 million of availability under its revolving credit facility.

In March 2021 the Company successfully completed the syndication of $1.185 billion in new term loan commitments in a four times oversubscribed transaction. The term loans will be used in connection with and contingent upon the Company’s planned merger with Landcadia Holdings III, Inc. (“Landcadia III”), a publicly-traded special purpose acquisition company, to repay all existing outstanding indebtedness. In addition, the financing includes a $250 million, five-year asset-based revolving credit facility, also contingent on closing of the merger with Landcadia III. Through the merger, refinancing and related transactions, the Company will simplify its capital structure and substantially lower expected total cash interest costs.

Planned Merger with Landcadia III

On January 25, 2021, Hillman and Landcadia III announced that they entered into a definitive merger agreement that will result in Hillman becoming a publicly listed company. Upon the closing of the transaction, which is expected to occur in the second quarter of 2021, the combined company will be named Hillman Solutions Corp. and remain listed on Nasdaq under the new ticker symbol “HLMN.”

Conference Call and Webcast
The Company will host a conference call to discuss the financial results for the first quarter ended March 27, 2021 on Tuesday, May 11, 2021, at 8:30 am Eastern time. Participants may join the call by dialing 1-(855)-327-6837 a few minutes before the call start time. A live audio webcast of the conference call will also be available in a listen-only mode on the Investor Info page of the Company’s website, which is located at www.hillmangroup.com. Participants who want to access the webcast should visit the company’s website about five minutes before the call. The archived webcast will be available for replay on the Company’s website after the call.

About Hillman

Founded in 1964 and headquartered in Cincinnati, Ohio, Hillman is a leading North American provider of complete hardware solutions, delivered with industry best customer service to over 40,000 locations. Hillman designs innovative product and merchandising solutions for complex categories that deliver an outstanding customer experience to home improvement centers, mass merchants, national and regional hardware stores, pet supply stores, and OEM & Industrial customers. Leveraging a world-class distribution and sales network, Hillman delivers a “small business” experience with “big business” efficiency. For more information on Hillman, visit www.hillmangroup.com.   

Landcadia Holdings III, Inc.

Landcadia III is a blank check company whose business purpose is to effect a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses. Landcadia III’s sponsors are TJF, LLC, which is wholly-owned by Mr. Fertitta, and Jefferies Financial Group Inc. Landcadia III’s management team is led by Mr. Fertitta, its Chief Executive Officer and Co-Chairman of its Board of Directors and the sole shareholder, Chairman and Chief Executive Officer of Fertitta Entertainment, Inc., and Mr. Handler, Landcadia III’s President, other Co-Chairman of its Board of Directors and the Chief Executive Officer of Jefferies Financial Group Inc. Landcadia III raised $500,000,000 in its initial public offering in October 2020 and is listed on Nasdaq under the ticker symbol “LCY.”

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. The Company’s and Landcadia III’s actual results may differ from their expectations, estimates and projections and consequently, you should not rely on these forward looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s and Landcadia III’s expectations with respect to future performance and anticipated financial impacts of the proposed business combination, the satisfaction of the closing conditions to the proposed transaction and the timing of the completion of the proposed transaction. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside the Company’s and Landcadia III’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: (1) the risk that the proposed business combination disrupts the Company’s current plans and operations; (2) the ability to recognize the anticipated benefits of the proposed business combination, which may be affected by, among other things, competition, the ability of the Company to grow and manage growth profitably and retain its key employees; (3) costs related to the proposed business combination; (4) changes in applicable laws or regulations; (5) the possibility that Landcadia III or the Company may be adversely affected by other economic, business, and/or competitive factors; (6) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; (7) the outcome of any legal proceedings that may be instituted against Landcadia III or the Company following the announcement of the merger agreement; (8) the inability to complete the proposed business combination, including due to failure to obtain approval of the stockholders of Landcadia III or Hillman, certain regulatory approvals or satisfy other conditions to closing in the merger agreement; (9) the impact of COVID-19 on the Company’s business and/or the ability of the parties to complete the proposed business combination; (10) the inability to obtain or maintain the listing of the combined company’s shares of common stock on Nasdaq following the proposed transaction; or (11) other risks and uncertainties indicated from time to time in the registration statement containing the proxy statement/prospectus relating to the proposed business combination, including those under “Risk Factors” therein, and in Landcadia III’s or the Company’s other filings with the SEC. The foregoing list of factors is not exclusive, and readers should also refer to those risks that will be included under the header “Risk Factors” in the registration statement on Form S-4 filed by Landcadia III with the SEC and those included under the header “Risk Factors” in Landcadia III’s Annual Report on Form 10-K/A. Readers are cautioned not to place undue reliance upon any forward-looking statements in this press release, which speak only as of the date made. Landcadia III and the Company do not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements in this press release to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

Participants in the Solicitation

Landcadia III and Hillman and their respective directors and officers may be deemed participants in the solicitation of proxies of Landcadia III’s stockholders in connection with the proposed business combination. A list of the names of Landcadia III’s directors and executive officers and a description of their interests in Landcadia III is contained in Landcadia III’s Annual Report on Form 10-K/A for the year ended December 31, 2020, which was filed with the SEC and is available free of charge at the SEC’s web site at www.sec.gov. Information about the Company’s directors and executive officers is available in Hillman’s Annual Report on Form 10-K for the year ended December 26, 2020 and certain of its Current Reports on Form 8-K.

Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies to Landcadia III stockholders in connection with the proposed business combination is set forth in the registration statement on Form S-4 containing the proxy statement / prospectus for the business combination. Additional information regarding the interests of participants in the solicitation of proxies in connection with the proposed business combination is included in the proxy statement that Landcadia III filed with the SEC, including Jefferies Financial Group Inc.’s and/or its affiliate’s various roles in the transaction. You should keep in mind that the interest of participants in such solicitation of proxies may have financial interests that are different from the interests of the other participants. These documents can be obtained free of charge from the sources indicated above.

Additional Information

In connection with the proposed business combination between the Company and Landcadia Holdings III, Inc. (Nasdaq: LCY) (“Landcadia III”), Landcadia III filed a registration statement on Form S-4 with the Securities and Exchange Commission (the “SEC”), which includes a proxy statement/prospectus, that will be both the proxy statement to be distributed to holders of Landcadia III’s common stock in connection with its solicitation of proxies for the vote by Landcadia III’s stockholders with respect to the proposed business combination and other matters as may be described in the registration statement, as well as the prospectus relating to the offer and sale of the securities to be issued in the business combination. After the registration statement is declared effective, Landcadia III will mail a definitive proxy statement/prospectus and other relevant documents to its stockholders. This document does not contain all the information that should be considered concerning the proposed business combination and is not intended to form the basis of any investment decision or any other decision in respect of the business combination. Landcadia III’s stockholders, the Company’s stockholders and other interested persons are advised to read the preliminary proxy statement/prospectus included in the registration statement and, when available, the amendments thereto and the definitive proxy statement/prospectus and other documents filed in connection with the proposed business combination, as these materials will contain important information about the Company, Landcadia III and the business combination. When available, the definitive proxy statement/prospectus and other relevant materials for the proposed business combination will be mailed to stockholders of Landcadia III as of a record date to be established for voting on the proposed business combination. Landcadia III’s stockholders and the Company’s stockholders will also be able to obtain copies of the preliminary proxy statement, the definitive proxy statement and other documents filed with the SEC, without charge, once available, at the SEC’s website at www.sec.gov, or by directing a request to: Landcadia Holdings III, Inc., 1510 West Loop South, Houston, Texas 77027, Attention: General Counsel, (713) 850-1010.

No Offer or Solicitation

This press release shall not constitute a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed transaction. This press release shall also not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Contacts

Investor Relations

Rodny Nacier / Brad Cray
[email protected]
(513) 826-5495

Public Relations

Phil Denning / Doug Donsky
[email protected]

THE HILLMAN COMPANIES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)

(dollars in thousands, except per share amounts)

  March 27,

2021
  December 26,

2020
ASSETS      
Current assets:      
Cash and cash equivalents $ 13,912       $ 21,520    
Accounts receivable, net of allowances of $2,271 ($2,395 – 2020) 136,742       121,228    
Inventories, net 459,740       391,679    
Other current assets 12,093       19,280    
Total current assets 622,487       553,707    
Property and equipment, net of accumulated depreciation of $251,082 ($236,031 – 2020) 175,321       182,674    
Goodwill 816,678       816,200    
Other intangibles, net of accumulated amortization of $306,509 ($291,434 – 2020) 811,496       825,966    
Operating lease right of use assets 77,479       76,820    
Deferred tax assets 3,650       2,075    
Other assets 12,522       11,176    
Total assets $ 2,519,633       $ 2,468,618    
LIABILITIES AND STOCKHOLDERS’ EQUITY      
Current liabilities:      
Accounts payable $ 220,323       $ 201,461    
Current portion of debt and capital leases 11,442       11,481    
Current portion of operating lease liabilities 11,528       12,168    
Accrued expenses:      
Salaries and wages 34,070       29,800    
Pricing allowances 3,788       6,422    
Income and other taxes 4,381       5,986    
Interest 8,138       12,988    
Other accrued expenses 30,499       31,605    
Total current liabilities 324,169       311,911    
Long term debt 1,581,458       1,535,508    
Deferred tax liabilities 151,693       156,118    
Operating lease liabilities 70,419       68,934    
Other non-current liabilities 30,420       31,560    
Total liabilities $ 2,158,159       $ 2,104,031    
Commitments and contingencies (Note 5)      
Stockholders’ Equity:      
Preferred stock, $0.01 par, 5,000 shares authorized, none issued or outstanding at March 27, 2021 and December 26, 2020          
Common stock, $0.01 par, 5,000 shares authorized, issued and outstanding at March 27, 2021 and December 26, 2020          
Additional paid-in capital 569,208       565,824    
Accumulated deficit (180,819 )     (171,849 )  
Accumulated other comprehensive loss (26,915 )     (29,388 )  
Total stockholders’ equity 361,474       364,587    
Total liabilities and stockholders’ equity $ 2,519,633       $ 2,468,618    
                   





THE HILLMAN COMPANIES, INC. AND SUBSIDIARIES


CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited)

(dollars in thousands)

  Thirteen Weeks
Ended


March 27, 2021
  Thirteen Weeks
Ended


March 28, 2020
Net sales $ 341,281       $ 295,836    
Cost of sales (exclusive of depreciation and amortization shown separately below) 201,298       166,411    
Selling, general and administrative expenses 103,179       89,753    
Depreciation 16,341       17,517    
Amortization 14,909       14,848    
Management fees to related party 126       125    
Other income (352 )     (2,264 )  
Income from operations 5,780       9,446    
Interest expense, net 19,019       23,180    
Interest expense on junior subordinated debentures 3,152       3,152    
(Gain) loss on mark-to-market adjustment of interest rate swap (673 )     2,250    
Investment income on trust common securities (95 )     (95 )  
Loss before income taxes (15,623 )     (19,041 )  
Income tax (benefit) (6,653 )     (4,237 )  
Net loss $ (8,970 )     $ (14,804 )  
Net loss from above $ (8,970 )     $ (14,804 )  
Other comprehensive income (loss):      
Foreign currency translation adjustments 2,473       (11,213 )  
Total other comprehensive income (loss) 2,473       (11,213 )  
Comprehensive loss $ (6,497 )     $ (26,017 )  
                   





THE HILLMAN COMPANIES, INC. AND SUBSIDIARIES


CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)

(dollars in thousands)

  Thirteen Weeks
Ended


March 27, 2021
  Thirteen Weeks
Ended


March 28, 2020
Cash flows from operating activities:      
Net loss $ (8,970 )     $ (14,804 )  
Adjustments to reconcile net loss to net cash provided by operating activities:      
Depreciation and amortization 31,250       32,365    
Deferred income taxes (5,955 )     (3,861 )  
Deferred financing and original issue discount amortization 904       943    
Stock-based compensation expense 1,741       1,145    
Change in fair value of contingent consideration       (4,400 )  
Other non-cash interest and change in value of interest rate swap (673 )     2,250    
Changes in operating items:      
Accounts receivable (15,155 )     (26,384 )  
Inventories (55,407 )     1,527    
Other assets (5,405 )     (1,768 )  
Accounts payable 18,485       1,072    
Other accrued liabilities (6,204 )     (5,726 )  
Net cash used by operating activities (45,389 )     (17,641 )  
Cash flows from investing activities:      
Acquisition of business, net of cash received       (800 )  
Capital expenditures (9,077 )     (15,404 )  
Net cash used in investing activities (9,077 )     (16,204 )  
Cash flows from financing activities:      
Repayments of senior term loans (2,652 )     (2,652 )  
Borrowings on revolving credit loans 62,000       46,500    
Repayments of revolving credit loans (14,000 )     (12,000 )  
Principal payments under finance and capitalized lease obligations (227 )     (206 )  
Proceeds from exercise of stock options 1,643          
Net cash provided by financing activities 46,764       31,642    
Effect of exchange rate changes on cash 94       (610 )  
Net decrease in cash and cash equivalents (7,608 )     (2,813 )  
Cash and cash equivalents at beginning of period 21,520       19,973    
Cash and cash equivalents at end of period $ 13,912       $ 17,160    
Supplemental disclosure of cash flow information:      
Interest paid on junior subordinated debentures, net $ 3,057       $ 4,077    
Interest paid 22,156       26,841    
Income taxes, net of refunds 8       (18 )  
               


Non-GAAP Financial Measures

Adjusted EBITDA is a non-GAAP financial measure and is the primary basis used to measure the operational strength and performance of our businesses as well as to assist in the evaluation of underlying trends in our businesses. This measure eliminates the significant level of noncash depreciation and amortization expense that results from the capital-intensive nature of our businesses and from intangible assets recognized in business combinations. It is also unaffected by our capital and tax structures, as our management excludes these results when evaluating our operating performance. Our management and Board of Directors use this financial measure to evaluate our consolidated operating performance and the operating performance of our operating segments and to allocate resources and capital to our operating segments. Additionally, we believe that Adjusted EBITDA is useful to investors because it is one of the bases for comparing our operating performance with that of other companies in our industries, although our measure of Adjusted EBITDA may not be directly comparable to similar measures used by other companies.

The following table presents a reconciliation of Net loss, the most directly comparable financial measures under GAAP, to Adjusted EBITDA for the periods presented:

  Thirteen Weeks Ended

March 27, 2021
  Thirteen Weeks Ended

March 28, 2020
Net loss $ (8,970 )     $ (14,804 )  
Income tax benefit (6,653 )     (4,237 )  
Interest expense, net 19,019       23,180    
Interest expense on junior subordinated debentures 3,152       3,152    
Investment income on trust common securities (95 )     (95 )  
Depreciation 16,341       17,517    
Amortization 14,909       14,848    
Mark-to-market adjustment on interest rate swaps (673 )     2,250    
EBITDA $ 37,030       $ 41,811    
       
Stock compensation expense 1,741       1,145    
Management fees 126       125    
Restructuring (1) 109       1,730    
Litigation expense (2) 3,960       781    
Acquisition and integration expense (3) 4,840       329    
Change in fair value of contingent consideration       (4,400 )  
Adjusted EBITDA $ 47,806       $ 41,521    
                   

(1) Restructuring includes restructuring costs associated with restructuring in our Canada segment announced in 2018, including facility consolidation, severance, sale of property and equipment, and charges relating to exiting certain lines of business. Also included is restructuring in our United Stated business announced in 2019, including severance related to management realignment and the integration of sales and operating functions. Finally, includes consulting and other costs associated with streamlining our manufacturing and distribution operations.
(2) Litigation expense includes legal fees associated with our ongoing litigation with KeyMe, Inc..
(3) Acquisition and integration expense includes professional fees, non-recurring bonuses, and other costs related to the pending merger along with historical acquisitions.



908 Devices Launches New Aerosol Module for Handheld MX908

908 Devices Launches New Aerosol Module for Handheld MX908

New Features Enable Detection of Aerosols and New Synthetic Drug Targets; Remote Bluetooth App Enables Rapid Data Sharing

BOSTON–(BUSINESS WIRE)–908 Devices (NASDAQ:MASS), a pioneer of purpose-built handheld and desktop mass spec devices for chemical and biomolecular analysis, today announced updates to its MX908 handheld mass spec device including a first-of-its-kind aerosol module to detect and identify aerosolized chemical threats; added targets allowing responders to recognize additional priority drug substances; and activation of a Bluetooth capability to export reports and device history to Android devices. These added capabilities address gaps in responders’ workflows and speed chemical detection at the point-of-need for multiple missions.

The Aero:Detect and identify toxic aerosols and vapor threats

The MX908 with Aero enables real-time monitoring for aerosolized threats, including aerosolized chemical warfare agents, fourth-generation agents, pharmaceutical-based agents, opioids and more. Within seconds, the MX908 provides immediate actionable results to guide response protocols for responders, including chemical and hazmat teams, law enforcement, and international customs agents – ensuring that whenever a responder encounters a highly toxic and unknown threat, they are empowered to move forward with fast and intelligent remediation.

“This industry-first capability fills a critical gap by allowing for the simultaneous monitoring, detection and identification of both vapor and aerosol hazards,” said John Kenneweg, Vice President, Government Sales, 908 Devices. “Aerosolized threats have unique physical properties and behavior that make it difficult for legacy detectors to identify them. The MX908 keeps response teams ahead of the latest chemical warfare threats, such as Novichoks, pharmaceutical based agents, opioid analogs and more – meeting a pressing and evolving need that no other device can today.”

Added Targets: Robust library for users identifying trace levels of controlled substances

As part of 908 Devices’ continued investment in expanding MX908’s threat detection capabilities, the handheld device can now detect and identify a broader range of cathinones and cannabinoids as well as select phenylethylamines. In the United States Drug Enforcement Administration’s annual report, National Drug Threat Assessment, the agency reported synthetic cannabinoids and cathinones are amongst the most commonly abused substances in the United States with new variants often introduced and increasing in prevalence. These additions to the MX908 target list are pivotal for responders identifying these substances in local communities and at crime scenes related to drug smuggling, transportation and/or distribution.

New Bluetooth Capability: Quickly and easily disseminate important information to those who need it

The new Bluetooth capability allows responders to facilitate data transfer and accelerate support in the field through a more seamless user experience. By pairing with the Remote application on an Android device, MX908 now provides a more rapid and efficient workflow for sharing results and accessing technical support from 908 Devices. In-app access to user documentation and training videos ensures responders in the field have the reference tools they need, in the palm of their hands.

“This enhancement enables responders to streamline their workflows and function with interoperability at their point-of-need,” said Maura Fitzpatrick, Vice President of Product Management and Marketing, 908 Devices. “Field teams can now download the MX908’s results faster and disseminate information to their teams with an easy data transfer. This allows for improved responder safety and expedited incident responses with reliable, accurate, and speedy chemical detection.”

The MX908 identifies a wide spectrum of substances, including solids, liquids and vapors, and now aerosols at trace level – and is a critical analytical tool for chemical, explosive, priority drug and hazmat operations. These updates come on the heels of the company’s announcement of a $25 million multi-year deal with U.S. Army.

To learn more about 908 Devices, please visit: https://908devices.com/.

About 908 Devices

908 Devices (NASDAQ:MASS) is democratizing laboratory mass spectrometry with its simple handheld and desktop devices, addressing critical-to-life applications. The Company’s devices are used at the point-of-need to interrogate unknown and invisible materials and provide quick, actionable answers to directly address some of the most critical problems in life sciences research, bioprocessing, pharma / biopharma, forensics, and adjacent markets. The Company is headquartered in the heart of Boston, where it designs and manufactures innovative products that bring together the power of mass spectrometry, microfluidic separations, software automation, and machine learning.

908 Devices

Emily Fang

PAN Communications for 908 Devices

[email protected]

Carrie Mendivil, [email protected]

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Chemicals/Plastics Health Technology Other Technology Manufacturing Pharmaceutical

MEDIA:

Logo
Logo