IN8bio to Present at the H.C. Wainwright Immune Cell Engager Virtual Conference

On August 15, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported that William Ho, CEO and co-founder, will participate in a fireside chat at the H.C. Wainwright Immune Cell Engager Virtual Conference on Thursday, August 17, 2023 at 2:00 pm ET (Press release, In8bio, AUG 15, 2023, View Source [SID1234634423]).

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The H.C. Wainwright presentation will be available live and as a replay on IN8bio’s website at https://bit.ly/3F1WEaQ.

Gritstone bio and Genevant Sciences Announce Option and License Agreement

On August 15, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, and Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust and expansive lipid nanoparticle (LNP) patent portfolio, reported an agreement pursuant to which Gritstone bio, Inc. will have a multi-year option for a non-exclusive license under Genevant’s LNP technology on a pathogen-by-pathogen basis to develop and commercialize self-amplifying RNA (samRNA) vaccines (Press release, Gritstone Bio, AUG 15, 2023, View Source [SID1234634422]).

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"Our previous collaborations with Genevant have demonstrated the powerful potential of combining the strengths of two technology leaders, and we are pleased to expand our relationship with this new agreement," said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone bio. "With the established complementarity between our samRNA technology and Genevant’s LNP technology, evident in clinical datasets in both oncology and infectious disease, we are now even better positioned to capitalize on the emergence of RNA vaccines and therapeutics to address a broader array of infectious diseases."

"The key role that LNP technology has played and can continue to play in the emergence of important medical advances has been a focus of Genevant scientists for over two decades," said Pete Lutwyche, Ph.D., President and Chief Executive Officer, Genevant Sciences Corporation. "As leaders in the field, we are thrilled to build upon our relationship with Gritstone to pursue new and better approaches to combat infectious disease."

Under the terms of the agreement, Genevant is eligible to receive from Gritstone option maintenance and exercise fees in the single digit millions, up to $136 million in contingent milestone payments per product, subject to increase for multi-pathogen products and in other specified circumstances, and royalties ranging from the mid to high single digits on future product sales. If Gritstone outlicenses an applicable infectious disease program, in lieu of certain of these payments, Genevant may be entitled to a percentage of amounts that Gritstone receives from its sublicensee.

Curium announces achievement of co-primary endpoints in phase 2 of its phase 1/2 SOLAR clinical trial imaging men with histologically-proven prostate cancer using copper Cu 64 PSMA I&T

On August 15, 2023 Curium, a world leader in nuclear medicine, reported the positive results of the multi-center, open-label, Phase 2 SOLAR study of Copper Cu 64 PSMA I&T in patients with histologically-proven metastatic prostate cancer (Press release, Curium, AUG 15, 2023, View Source [SID1234634421]). The study has met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate. The purpose of this study was to evaluate the safety, biodistribution, and image quality of Copper Cu 64 PSMA I&T to detect metastatic prostate cancer using PET/CT imaging. The SOLAR Phase 2 study was conducted in the U.S. and included a group of 26 patients with metastatic prostate cancer.

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Michael Patterson, CEO – North America at Curium commented, "The milestone announced today demonstrates Curium’s global commitment to driving innovations in prostate cancer diagnosis and treatment, and is extremely encouraging for prostate cancer patients. Our proven ability to reliably manufacture and distribute Cu-64 diagnostic agents throughout the U.S. means that we are well positioned for the upcoming Phase 3 trials to ultimately improve the lives of patients."

Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented, "We are very pleased to report that our Copper Cu 64 PSMA I&T product for PET/CT imaging in the detection of recurrent prostate cancer has met the co-primary endpoints. Consistent with our mission to redefine the experience of cancer through our trusted legacy in nuclear medicine, we are encouraged by the readouts of the SOLAR Phase 2 clinical trial. Our goal is to accelerate the Copper Cu 64 PSMA I&T Phase 3 clinical development and move forward with pivotal Phase 3 clinical trials in biochemical recurrence and initial staging setting in metastatic prostate cancer in early 2024."

Prostate cancer is the second most common cancer after skin cancer among men in the United States. There will be an estimated 288,000 new cases of prostate cancer in 2023.

For more information about the SOLAR trial: View Source

To contact Curium’s SOLAR clinical trial team: [email protected]

Cardinal Health Reports Fourth Quarter and Full Year Results for Fiscal Year 2023 at High End of Investor Day Guidance

On August 15, 2023 Cardinal Health (NYSE: CAH) reported fourth quarter fiscal year 2023 revenues of $53.5 billion, an increase of 13% from the fourth quarter of last year. GAAP operating earnings were $137 million, primarily due to a non-cash, pre-tax goodwill impairment charge of $368 million in the Medical segment, which reflects the financial update provided at Investor Day (Press release, Cardinal Health, AUG 15, 2023, View Source [SID1234634420]). GAAP diluted loss per share was $0.25, primarily due to this impairment, net of tax effects. Non-GAAP operating earnings increased 24% to $560 million, driven by increases in Medical and Pharmaceutical segment profit. Non-GAAP diluted earnings per share (EPS) increased 48% to $1.55 in the quarter, reflecting the increase in non-GAAP operating earnings, lower interest and other expense and a lower share count, partially offset by a higher non-GAAP effective tax rate.

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Fiscal year 2023 revenues were $205.0 billion, a 13% increase from fiscal year 2022. GAAP operating earnings were $727 million, due to cumulative non-cash, pre-tax goodwill impairment charges of $1.2 billion in the Medical segment. GAAP diluted EPS were $1.00, primarily due to these impairments, net of tax effects. Non-GAAP operating earnings increased 3% to $2.1 billion, driven by an increase in Pharmaceutical segment profit, partially offset by a decrease in Medical segment profit. Non-GAAP diluted EPS increased 14% to $5.79 for the year, an all-time high, reflecting the increase in non-GAAP operating earnings, lower interest and other expense and a lower share count.

"Fiscal 2023 was an inflection point for Cardinal Health, with improved performance, strong execution and notable progress against both our short and long-term plans," said Jason Hollar, CEO of Cardinal Health. "We are pleased with the strong finish to the year, including robust cash flow generation, continued strong growth in the Pharmaceutical segment and significant improvement in the Medical segment, driven by execution of our Medical Improvement Plan. We enter the new fiscal year with momentum and are raising our previously communicated fiscal year 2024 EPS guidance."

Q4 and full year FY23 summary

Q4 FY23

Q4 FY22

Y/Y

FY23

FY22

Y/Y

Revenue

$53.5 billion

$47.1 billion

13 %

$205.0 billion

$181.4 billion

13 %

Operating earnings/(loss)

$137 million

$36 million

N.M.

$727 million

$(596) million

N.M.

Non-GAAP operating earnings

$560 million

$450 million

24 %

$2.1 billion

$2.0 billion

3 %

Net earnings/(loss) attributable to Cardinal Health, Inc.

$(64) million

$138 million

N.M.

$261 million

$(933) million

N.M.

Non-GAAP net earnings attributable to Cardinal Health, Inc.

$397 million

$289 million

37 %

$1.5 billion

$1.4 billion

7 %

Effective Tax Rate3

154.3 %

575.3 %

58.9 %

(21.2) %

Non-GAAP Effective Tax Rate

27.4 %

25.4 %

22.8 %

22.1 %

Diluted EPS attributable to Cardinal Health, Inc.

$(0.25)

$0.50

N.M.

$1.00

$(3.35)

N.M.

Non-GAAP diluted EPS attributable to Cardinal Health, Inc.

$1.55

$1.05

48 %

$5.79

$5.06

14 %

Segment results

Pharmaceutical segment

Q4 FY23

Q4 FY22

Y/Y

FY23

FY22

Y/Y

Revenue

$49.7 billion

$43.3 billion

15 %

$190.0 billion

$165.5 billion

15 %

Segment profit

$504 million

$451 million

12 %

$2.0 billion

$1.8 billion

13 %

Fourth-quarter revenue for the Pharmaceutical segment increased 15% to $49.7 billion, driven by brand and specialty pharmaceutical sales growth from existing customers.

Pharmaceutical segment profit increased 12% to $504 million in the fourth quarter, primarily driven by positive generics program performance.

Medical segment

Q4 FY23

Q4 FY22

Y/Y

FY23

FY22

Y/Y

Revenue

$3.8 billion

$3.8 billion

— %

$15.0 billion

$15.9 billion

(5) %

Segment profit

$82 million

$(16) million

N.M.

$111 million

$216 million

(49) %

Fourth-quarter revenue for the Medical segment was flat at $3.8 billion. This reflects a decrease in Products and Distribution sales related to lower PPE volumes and pricing, partially offset by inflationary impacts, including mitigation initiatives. This decrease within Products and Distribution was offset by growth in at-Home Solutions.

Medical segment profit increased to $82 million in the fourth quarter, driven by an improvement in net inflationary impacts, including mitigation initiatives, and normalization of PPE margins.

Fiscal year 2024 outlook1,4

The company raised its fiscal year 2024 outlook for non-GAAP earnings per share by $0.05 to $6.50 to $6.75 from the preliminary outlook previously communicated at the company’s Investor Day5, which primarily reflects increased expectations for Pharmaceutical segment profit. The company reiterated its fiscal year 2024 Pharmaceutical segment profit outlook for 4% to 6% growth on higher ending fiscal year 2023 Pharmaceutical segment profit. The company also increased its fiscal year 2024 Pharmaceutical revenue outlook, driven by continued growth of GLP-1 medications, which do not meaningfully contribute to segment profit. Additionally, the company narrowed its range for diluted weighted average shares outstanding. The company reiterated its expectations for all other fiscal year 2024 outlook items:

Non-GAAP earnings per share

$6.50 – $6.75

Pharmaceutical segment:

Revenue

10% to 12% growth

Segment profit

4% to 6% growth

Medical segment:

Revenue

~3% growth

Segment profit

~$400M

Interest and other

$110M – $130M

Non-GAAP effective tax rate

23.0% – 25.0%

Diluted weighted average shares outstanding

250M – 253M

Share repurchases

~$500M

Capital Expenditures

~$500M

Non-GAAP adjusted free cash flow

~$2.0B

Recent highlights

Cardinal Health hosted an Investor Day on June 8th, 2023 where management detailed the company’s growth strategies, highlighted plans for value creation and provided compelling long-term targets.
Cardinal Health completed its business and portfolio review of the Pharmaceutical segment, which included the launch of the new Navista Network supporting community oncologists, the announcement to retain and invest in Nuclear & Precision Health Solutions and the merger of its Outcomes business into Transaction Data Systems.
Cardinal Health announced a new agreement with TrakCel to offer an integrated cell and gene therapy software solution to help biopharma companies track cell therapies through multiple stages of development and commercialization.
Cardinal Health hosted its 31st annual Retail Business Conference, bringing together nearly 4,500 attendees from across the country to celebrate the critical role its independent pharmacy customers play in caring for their communities and highlight the company’s innovations and commitment to its customers.
Cardinal Health announced plans to build a new distribution center in the Greenville, South Carolina, area, to support its at-Home Solutions business.
Cardinal Health was named one of the 2023 Best Companies for Multicultural Women by Seramount.
Cardinal Health Board of Directors approved a quarterly dividend of $0.5006 per share.
Upcoming webcasted investor events

Morgan Stanley 21st Annual Global Healthcare Conference at 9:30am ET, September 12, 2023
Baird 2023 Global Healthcare Conference at 8:30am ET, September 13, 2023
Webcast

Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss fourth quarter and full year results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until August 14, 2024.

BIO-TECHNE TO PRESENT AT THE UBS MEDTECH, TOOLS AND GENOMICS SUMMIT 2023

On August 15, 2023 Bio-Techne Corporation (NASDAQ: TECH) reported that Jim Hippel, Executive Vice President and Chief Financial Officer, will present at the UBS MedTech, Tools and Genomics Summit 2023 on Thursday, August 17, 2023, at 10:00 a.m. PDT (Press release, Bio-Techne, AUG 15, 2023, View Source [SID1234634419]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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