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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BIO-PATH HOLDINGS REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS

On August 15, 2023 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the second quarter ended June 30, 2023 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, AUG 15, 2023, View Source [SID1234634418]).

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"Our clinical progress this quarter was highlighted by the compelling interim results from Stage 2 of our Phase 2 study of prexigebersen as a treatment for acute myeloid leukemia, a blood cancer for which there are limited treatment options and for which the prognosis is grave," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "The data showed prexigebersen demonstrated meaningful clinical improvement with a tolerable safety profile in these high-risk patients. On the strength of these data, we now plan to file for regulatory designations that may accelerate the pathway for bringing this potentially life-expanding therapy to patients battling this deadly hematologic cancer."

"We continue to advance our robust clinical development program across a number of important programs that leverage our innovative DNAbilize platform technology to deliver RNAi nanoparticle therapeutics directly to cancer cells. We are forging a new path in DNA-powered medicine that we believe will give patients a fighting chance to beat these difficult to treat cancers," continued Mr. Nielsen.

Recent Corporate Highlights

• Announced Positive Results from Interim Analysis of Phase 2 Clinical Trial of Prexigebersen in Acute Myeloid Leukemia. In August, Bio-Path reported positive interim data from Stage 2 of the Company’s Phase 2 study of prexigebersen in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML). Prexigebersen continues to be well-tolerated and has now shown compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, which exceed outcomes with combination treatment of decitabine and venetoclax. Financial Results for the Second Quarter Ended June 30, 2023

• The Company reported a net loss of $4.2 million, or $0.53 per share, for the three months ended June 30, 2023, compared to a net loss of $3.0 million, or $0.42 per share, for the three months ended June 30, 2022.

• Research and development expense for the three months ended June 30, 2023 increased to $3.1 million, compared to $1.9 million for the three months ended June 30, 2022 primarily due to manufacturing expenses related to drug product releases during the second quarter of 2023 and increased patient enrollment related to our Phase 2 clinical trial for prexigebersen in AML.

• General and administrative expense for both the three months ended June 30, 2023 and June 30, 2022 was $1.2 million.
• As of June 30, 2023, the Company had cash of $3.4 million, compared to $10.4 million as of December 31, 2022. Net cash used in operating activities for the six months ended June 30, 2023 was $6.9 million compared to $6.7 million for the comparable period in 2022.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these second quarter 2023 financial results and to provide a general update on the Company. To access the conference call please dial (833) 630-1956 (domestic) or (412) 317-1837 (international). A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

AIM ImmunoTech Reports Second Quarter Financial Results and Provides Clinical Pipeline Update

On August 15, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported its financial results for the second quarter 2023 and provided a business update (Press release, AIM ImmunoTech, AUG 15, 2023, View Source [SID1234634417]). As previously announced, the Company will host a conference call and audio webcast on Tuesday, August 15, 2023, at 8:30 AM ET (details below).

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"Over the course of the second quarter, our team continued to deliver on our timelines and made significant progress advancing Ampligen through our active human clinical studies in multiple indications. We continue to be encouraged by the growing body of positive and consistent data and believe Ampligen has the potential to be a meaningful treatment option across a number of high-value indications," commented Thomas K. Equels, Chief Executive Officer of AIM. "Our operational execution remains supported by a strong cash position, and we are steadfast in our mission to advance the clinical development of our oncology pipeline, with pancreatic cancer as our lead development program. Looking ahead to the remainder of the year, we believe we are well-positioned to achieve a number of value-driving milestones."

Recent Highlights

Ampligen identified as one of two potential therapeutics possessing modest to high potential for the treatment of post-COVID conditions out of 22 identified on-going randomized clinical trials in recent peer-reviewed publication.
Received updated data from Early Access Program (EAP) at Erasmus Medical Center which bolsters previously published data indicating that treatment with Ampligen following FOLFIRINOX was associated with improved survival rates in pancreatic cancer patients compared to matched controls of patients who did not receive Ampligen.
Commenced and completed full enrollment in the Company’s Phase 2 study evaluating Ampligen as a potential therapeutic for people with post-COVID conditions (AMP-518).
Announced the publication of pre-clinical data that suggests Ampligen has the potential to act directly on tumor cells to reduce tumor cell growth in pancreatic cancer patients with sufficient tumor levels of TLR-3, suggesting a potential biomarker to identify patients who may respond to Ampligen. The anti-tumor analysis was published in the peer-reviewed journal American Journal of Cancer Research in the paper "Rintatolimod: A potential treatment in patients with pancreatic cancer expressing Toll-like receptor 3."
Received the required approvals from the Netherlands for Erasmus Medical Center ("Erasmus MC") to begin a Phase 1b/2 study under the previously announced external sponsored collaborative clinical research agreement with AstraZeneca and Erasmus MC.
Announced the opening of an additional clinical trial site at University of Nebraska for Phase 2 study of Ampligen for the treatment of pancreatic cancer (AMP-270).
Granted patent No. 2022/01079, titled "Compositions and Methods Useful for Ebola Virus Infection" by the South African Patent and Trademark Office (CIPC).
Ampligen Expected Upcoming Pipeline Milestones

Q3 2023

Locally Advanced Pancreatic Cancer: Enroll and dose first patient in Phase 2 study
Advanced Recurrent Ovarian Cancer: Announce protocol-planned interim results
Q4 2023

Metastatic Pancreatic Cancer: Enroll and dose first patient in Phase 1b/2 study evaluating Ampligen in combination with AstraZeneca’s Imfinzi (durvalumab)
Summary of Financial Highlights for Second Quarter 2023

As of June 30, 2023, AIM reported cash, cash equivalents and marketable securities of $28.4 million. Based on management’s current expectation, the Company’s cash runway is expected to fund operations through multiple key milestones through the end of 2024.
Research and development expenses for the three months ended June 30, 2023 were $3.0 million, compared to $2.5 million for the same period in 2022.
General and administrative expenses were $2.6 million for the three months ended June 30, 2023, compared to $2.2 million for the same period 2022.
The net loss from operations for the three months ended June 30, 2023 was $4.9 million, or $0.10 per share, compared to $4.9 million, or $0.10 per share, for the three months ended June 30, 2022.
Please refer to the full 10-Q for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host a quarterly conference call and live audio webcast to discuss the operational and financial results on August 15, 2023, at 8:30 AM ET.

The call will be hosted by members of AIM, CEO Thomas K. Equels and Scientific Officer Christopher McAleer, PhD. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The live webcast will be accessible on the Events page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.