On April 19, 2023, AIM Immunotech Inc. (the "Company") reported to have entered into an Equity Distribution Agreement (the "Distribution Agreement"), with Maxim Group LLC ("Maxim"), pursuant to which the Company may sell from time to time, shares of its common stock, $0.001 par value per share, having an aggregate offering price of up to $8.5 million (the "Shares") through Maxim, as agent (the "Offering") (Press release, AIM ImmunoTech, APR 19, 2023, View Source [SID1234630295]). On April 19, 2023, the Company filed a prospectus supplement with the Securities and Exchange Commission (the "SEC") in connection with the Offering (the "Prospectus Supplement") under its existing Registration Statement on Form S-3 (File No 333-262280), which became effective on February 4, 2023 (the "Registration Statement"), related to the sale of Shares having an aggregate offering price of up to $100 million.

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Subject to the terms and conditions of the Distribution Agreement, Maxim will use its commercially reasonable efforts to sell the Shares from time to time, based on the Company’s instructions. Under the Distribution Agreement, Maxim may sell the Shares by any method permitted by law deemed to be an "at-the-market" offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including, without limitation, sales made directly on the NYSE American.

The Company has no obligation to sell any of the Shares, and may at any time suspend offers under the Distribution Agreement. The Offering will terminate upon the earlier of (i) the sale of Shares under the Distribution Agreement having an aggregate offering price of $8.5 million, 24 months from the date of the Distribution Agreement or the termination of the Distribution Agreement by either the Company or Maxim upon the provision of fifteen (15) days written notice. In addition, sales of Shares under the Offering shall not exceed $8.5 million, unless and until the Company files an amended or new Prospectus Supplement.

Under the terms of the Distribution Agreement, Maxim will be entitled to a transaction fee at a fixed rate of 3.0% of the gross sales price of Shares sold under the Distribution Agreement. The Company will also reimburse Maxim for certain expenses incurred in connection with the Distribution Agreement, and has agreed to provide indemnification and contribution to Maxim with respect to certain liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended.

The Company intends to use the net proceeds from the sale of Shares for working capital and general corporate purposes.

The foregoing description of the Distribution Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Distribution Agreement, a copy of which is filed hereto as Exhibit 10.1. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there by any offer, solicitation or sale of the Shares in any state or country in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or country.

The Distribution Agreement and the above description have been included to provide investors and security holders with information regarding the terms of the Distribution Agreement. They are not intended to provide any other factual information about the Company or its subsidiaries, affiliates or stockholders. The representations, warranties and covenants contained in the Distribution Agreement were made only for purposes of the Distribution Agreement and as of specific dates; were solely for the benefit of the parties to the Distribution Agreement; and may be subject to limitations agreed upon by the parties, including being qualified by confidential disclosures made by each contracting party to the other for the purposes of allocating contractual risk between them that differ from those applicable to investors. Investors should not rely on the representations, warranties and covenants or any description thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries, affiliates, businesses or stockholders. Moreover, information concerning the subject matter of the representations, warranties and covenants may change after the date of the Distribution Agreement, which subsequent information may or may not be fully reflected in public disclosures or statements by the Company. Accordingly, investors should read the representations and warranties in the Distribution Agreement not in isolation but only in conjunction with the other information about the Company and its subsidiaries that the Company includes in reports, statements and other filings made with the SEC.

Silverman Shin & Byrne PLLC, counsel to the Company, has issued a legal opinion relating to the Shares. A copy of this legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

Any Shares offered and sold in the Offering will be issued pursuant to the Company’s Registration Statement, the prospectus and the Prospectus Supplement relating to the Offering.

On April 19, 2023 Abbott (NYSE: ABT) reported financial results for the first quarter ended March 31, 2023 (Press release, Abbott, APR 19, 2023, View Source [SID1234630294]).

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First-quarter GAAP diluted EPS of $0.75 and adjusted diluted EPS of $1.03, which excludes specified items.
Projected full-year 2023 diluted EPS from continuing operations on a GAAP basis of $3.05 to $3.25 remains unchanged.

Projected full-year adjusted EPS from continuing operations of $4.30 to $4.50 remains unchanged and now reflects an increased outlook for the underlying base business offset by a lower forecasted earnings contribution from COVID-19 testing-related sales.

Abbott now projects full-year 2023 organic sales growth, excluding COVID-19 testing-related sales1, of at least high single-digits2 and COVID-19 testing-related sales of approximately $1.5 billion.

In January, Abbott announced U.S. Food and Drug Administration (FDA) approval of Navitor, its second-generation transcatheter aortic valve implantation system, for people with severe aortic stenosis who are at high risk for surgery.
In March, data was presented at the American College of Cardiology Scientific Sessions showing Abbott’s TriClip system was superior to current medical therapy in treating patients with severe tricuspid regurgitation, or a leaky tricuspid heart valve.
In March, Abbott’s market-leading FreeStyle Libre continuous glucose monitoring system received U.S. FDA clearance for integration with automated insulin delivery systems. Abbott is partnering with leading insulin pump manufacturers to integrate their systems with FreeStyle Libre 2 and FreeStyle Libre 3 as soon as possible.
"Our first-quarter results reflect a very strong start to the year," said Robert B. Ford, chairman and chief executive officer, Abbott. "Growth in our underlying base businesses accelerated, including particularly strong results in Medical Devices, Established Pharmaceuticals and Nutrition."

FIRST-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange, as well as the impact of exiting the pediatric nutrition business in China, is an appropriate way for investors to best understand the core underlying performance of the business.

Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand underlying base business performance as the COVID-19 pandemic shifts to an endemic state, resulting in significantly lower expected demand for COVID-19 tests.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Total Company

Reported Sales

Sales 1Q23 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

3,928

812

1,335

—

1,778

International

5,819

1,155

1,353

1,189

2,122

Total reported

9,747

1,967

2,688

1,189

3,900

% Change vs. 1Q22

U.S.

(20.4)

19.9

(50.8)

n/a

15.1

International

(16.4)

(5.1)

(46.9)

3.7

3.5

Total reported

(18.1)

3.8

(48.9)

3.7

8.5

Organic Sales

% Change vs. 1Q22

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

Reported

(18.1)

3.8

(48.9)

3.7

8.5

Impact of foreign exchange

(3.3)

(3.9)

(1.8)

(7.4)

(3.9)

Impact of business exit

(0.3)

(2.6)

—

—

—

Organic

(14.5)

10.3

(47.1)

11.1

12.4

Impact of COVID-19 testing sales3

(24.5)

—

(51.5)

—

—

Organic excluding COVID-19 tests

10.0

10.3

4.4

11.1

12.4

U.S.

12.6

19.9

0.3

n/a

15.1

International

8.6

4.8

6.8

11.1

10.4

n/a = Not Applicable.

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

Nutrition

Reported Sales

Sales 1Q23 ($ in millions)

Total

Pediatric

Adult

U.S.

812

459

353

International

1,155

465

690

Total reported

1,967

924

1,043

% Change vs. 1Q22

U.S.

19.9

36.1

3.9

International

(5.1)

(8.6)

(2.6)

Total reported

3.8

9.2

(0.5)

Organic Sales

% Change vs. 1Q22

Total

Pediatric

Adult

Reported

3.8

9.2

(0.5)

Impact of foreign exchange

(3.9)

(2.8)

(4.7)

Impact of business exit

(2.6)

(6.4)

—

Organic

10.3

18.4

4.2

U.S.

19.9

36.1

3.9

International

4.8

5.3

4.4

Worldwide Nutrition sales increased 3.8 percent on a reported basis and 10.3 percent on an organic basis in the first quarter. Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

In Pediatric Nutrition, global sales increased 9.2 percent on a reported basis and 18.4 percent on an organic basis. In the U.S., sales growth of 36.1 percent includes the impact of lower sales in the first quarter of the prior year due to a voluntary recall of certain infant formula products. Following a temporary manufacturing stoppage of these products, Abbott subsequently restarted production last year and continues to make good progress recovering market share in this business.

In Adult Nutrition, global sales decreased 0.5 percent on a reported basis and increased 4.2 percent on an organic basis, which was led by strong global growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand.

Diagnostics

Reported Sales

Sales 1Q23 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics *

U.S.

1,335

289

47

93

906

International

1,353

893

100

41

319

Total reported

2,688

1,182

147

134

1,225

% Change vs. 1Q22

U.S.

(50.8)

7.7

(72.7)

2.9

(58.4)

International

(46.9)

(2.5)

(59.7)

9.2

(76.3)

Total reported

(48.9)

(0.2)

(65.0)

4.7

(65.3)

Organic Sales

% Change vs. 1Q22

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics *

Reported

(48.9)

(0.2)

(65.0)

4.7

(65.3)

Impact of foreign exchange

(1.8)

(5.3)

(1.0)

(1.0)

(0.8)

Organic

(47.1)

5.1

(64.0)

5.7

(64.5)

Impact of COVID-19 testing sales3

(51.5)

(2.0)

(39.2)

—

(72.5)

Organic excluding COVID-19 tests

4.4

7.1

(24.8)

5.7

8.0

U.S.

0.3

9.0

(36.7)

2.9

(0.9)

International

6.8

6.5

(18.9)

12.7

23.2

*The Acelis Connected Health business was internally transferred from Rapid Diagnostics to Heart Failure on January 1, 2023. As a result, $29 million of sales for the first quarter of 2022 were moved from Rapid Diagnostics to Heart Failure.

As expected, Diagnostics sales growth in the first quarter was negatively impacted by year-over-year declines in COVID-19 testing-related sales3. Worldwide COVID-19 testing sales were $730 million in the first quarter of 2023 compared to $3.304 billion in the first quarter of the prior year.

Excluding COVID-19 testing-related sales, global Diagnostics sales increased 0.2 percent on a reported basis and increased 4.4 percent on an organic basis. Organic sales growth, excluding COVID-19 testing-related sales, was led by Core Laboratory, Point of Care and Rapid Diagnostics. In Molecular Diagnostics, growth was negatively impacted by lower demand for seasonal respiratory testing compared to significantly higher-than-usual demand in the first quarter of the prior year.

Established Pharmaceuticals

Reported Sales

Sales 1Q23 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

1,189

912

277

Total reported

1,189

912

277

% Change vs. 1Q22

U.S.

n/a

n/a

n/a

International

3.7

0.7

15.0

Total reported

3.7

0.7

15.0

Organic Sales

% Change vs. 1Q22

Total

Key Emerging
Markets

Other

Reported

3.7

0.7

15.0

Impact of foreign exchange

(7.4)

(7.6)

(6.8)

Organic

11.1

8.3

21.8

U.S.

n/a

n/a

n/a

International

11.1

8.3

21.8

Established Pharmaceuticals sales increased 3.7 percent on a reported basis and 11.1 percent on an organic basis in the first quarter.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 0.7 percent on a reported basis and 8.3 percent on an organic basis, led by growth in Brazil, China and Southeast Asia, and across several therapeutic areas, including cardiometabolic, respiratory and central nervous system/pain management.

Medical Devices

Reported Sales

Sales 1Q23 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure *

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

1,778

260

238

218

218

210

155

479

International

2,122

267

267

63

399

251

41

834

Total reported

3,900

527

505

281

617

461

196

1,313

% Change vs. 1Q22

U.S.

15.1

4.4

10.0

11.3

4.8

10.5

8.4

39.7

International

3.5

(3.2)

(1.0)

16.6

(2.7)

13.7

13.5

6.5

Total reported

8.5

0.4

3.9

12.4

(0.2)

12.2

9.4

16.6

Organic Sales

% Change vs. 1Q22

Total

Rhythm
Management

Electro-

physiology

Heart
Failure *

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

Reported

8.5

0.4

3.9

12.4

(0.2)

12.2

9.4

16.6

Impact of foreign exchange

(3.9)

(3.6)

(4.9)

(1.2)

(4.1)

(4.2)

(1.8)

(4.4)

Organic

12.4

4.0

8.8

13.6

3.9

16.4

11.2

21.0

U.S.

15.1

4.4

10.0

11.3

4.8

10.5

8.4

39.7

International

10.4

3.7

7.8

22.3

3.4

21.4

22.5

12.9

*The Acelis Connected Health business was internally transferred from Rapid Diagnostics to Heart Failure on January 1, 2023. As a result, $29 million of sales for the first quarter of 2022 were moved from Rapid Diagnostics to Heart Failure.

Worldwide Medical Devices sales increased 8.5 percent on a reported basis and 12.4 percent on an organic basis in the first quarter, including double-digit organic sales growth in both the U.S. and internationally.

Sales growth was led by double-digit organic growth in Diabetes Care, Structural Heart, Heart Failure and Neuromodulation. Several recently launched products and new indications contributed to the strong performance, including Amplatzer Amulet, Navitor, TriClip, Aveir and CardioMEMS.

In Electrophysiology, internationally, sales grew double-digits on a reported basis and high-teens on an organic basis in Europe, which was partially offset by soft market conditions in China during the first several weeks of the first quarter.

In Diabetes Care, FreeStyle Libre sales were $1.2 billion, which included U.S. growth of approximately 50 percent.

ABBOTT’S EARNINGS-PER-SHARE GUIDANCE
Abbott projects full-year 2023 diluted earnings per share from continuing operations under GAAP of $3.05 to $3.25. Abbott forecasts specified items for the full-year 2023 of $1.25 per share primarily related to intangible amortization, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $4.30 to $4.50 for the full-year 2023.

ABBOTT DECLARES 397TH CONSECUTIVE QUARTERLY DIVIDEND
On February 17, 2023, the board of directors of Abbott declared the company’s quarterly dividend of $0.51 per share. Abbott’s cash dividend is payable May 15, 2023, to shareholders of record at the close of business on April 14, 2023.

Abbott has increased its dividend payout for 51 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On April 19, 2023 Amplia Therapeutics reported that dosing of the first patient in Cohort 3 of the Company’s ongoing Phase 1b/2a ACCENT clinical trial of FAK inhibitor AMP945 in pancreatic cancer has begun (Press release, Amplia Therapeutics, APR 19, 2023, View Source;[email protected] [SID1234630265]).

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Cohort 3 will consist of three patients receiving an increased dose of AMP945 after the safety committee’s recent assessment that the AMP945 dose used in Cohort 2 was safe and well-tolerated. In the ACCENT trial, AMP945 is dosed orally (as a capsule) in the lead-up to, and between, standardised weekly dosing of gemcitabine and nab-paclitaxel chemotherapy.

Amplia CEO and Managing Director, Dr Chris Burns, commented: "We are very pleased with the recent progress in the ACCENT trial and moving rapidly to Cohort 3 is the next step in identifying a safe and effective dose to take forward to the Phase 2 stage of the trial. We are extremely grateful to the clinical trial sites for their hard work in progressing the trial so quickly, and to the patients and their loved ones for agreeing to take part in this trial."

About the ACCENT Trial
The protocol for the ACCENT trial is entitled "A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients".

The trial is to be conducted in two stages. The first stage of the trial (Phase 1b) is an open-label study to select an optimal dose of AMP945 by assessing the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AMP945 when dosed in combination with gemcitabine and nab-paclitaxel in first-line patients with advanced pancreatic cancer.

The second stage of the trial (Phase 2a) is also a single-arm, open-label study and is designed to determine the impact of AMP945 in combination with gemcitabine and nab-paclitaxel on patient outcomes. The primary endpoint of the Phase 2a trial is the Objective Response Rate (ORR) of patients to treatment. Further endpoints will assess efficacy by other means as well as safety and tolerability.

More information about the ACCENT trial, including a list of participating sites, can be found via our website and at ClinicalTrials.gov under the identifier NCT05355298. The Company will provide further updates on the trial as recruitment proceeds.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On April 18, 2023 Integra Therapeutics reported the company has been awarded a €335,000 non-refundable grant through the Spanish Ministry of Science and Innovation Neotec programme, managed by the Centre for the Development of Industrial Technology (CDTI) (Press release, Integra Therapeutics, APR 18, 2023, View Source [SID1234654533]).

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Neotec is a highly competitive programme that aims to foster technology and innovation for the development of companies based in Spain. In the 2022 call, the programme awarded grants to 135 projects. In this regard, it is significant that the Integra Therapeutics research project was among the top 20 because it highlights the company’s solid business model and the importance of developing more precise and effective advanced therapies for patients and the healthcare systems.

The grant will allow the company to continue the implementation of its FiCAT gene-writing platform for viral-free in vivo delivery to liver cells for gene therapy and generation of proof of concept data on its first therapeutic product, which will run until 2024.

The company will also reinforce its R&D team, hiring two senior scientists with a strong background protein engineering and bioinformàtics, respectively. Integra Therapeutics currently has a team of 13 highly qualified professionals at its headquarters in the Barcelona Biomedical Research Park (PRBB).

In addition to the grant, Integra Therapeutics will be able to take part in a training programme on Entrepreneurship, Innovation and Sustainability at the Georgia Institute of Technology in Atlanta (USA).

Integra Therapeutics is a global leader in creating next-generation gene-writing tools to make advanced therapies safer and more effective. Since it was established in 2020, the company has secured €8 million in venture capital (AdBio Partners, Columbus Venture Partners, Invivo Capital and Takeda Ventures) and through various competitive programmes of the European Union, Spanish Government and Government of Catalonia.

On April 18, 2023 Incurix, a company that develops anticancer drugs targeting transcription factors, reported the first pipeline clinical data (Approval number NCC2016-0208) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) held in April (Press release, Incurix, APR 18, 2023, View Source;idx=91&page=1&code=news [SID1234643574]).

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The AACR (Free AACR Whitepaper) is one of the largest conferences in the world, with participation from leading pharmaceutical and bio companies worldwide, and presentation is confirmed through selection by the organizers.

The research results to be presented were obtained through collaborative research with the National Cancer Center’s clinical research team.

Myc is a well-known factor that is overexpressed not only in solid tumors but also in blood cancers and is infamous for its role as a switch that promotes tumors. The activation of Myc in cancer leads to rapid resistance and progression to tumor promotion, making it a popular target in cancer treatment.

Incurix is developing a new anticancer drug designed to interfere with the Myc/Max complex’s approach to DNA binding sequences E-Box in cancer cells. At this conference, Incurix presented indication-related clinical data on the groundbreaking potential of a novel anticancer drug, ICX-101, targeting Myc, which is highly expressed in progressive lung cancer patients.

We confirmed the potential for ICX-101 to control cancer in connection with indications related to the high expression of myc in more than 100 clinical samples from about 80 lung cancer patients. They analyzed the myc expression rates for four types of lung cancer tissues (ADC, SQCC, NSCLC, SCLC) and confirmed the correlation between myc expression and tumor genes (ALK, BRAF, EGFR, MET).

We also confirmed the association of overall survival rates with the high level of myc expression. Furthermore, we showed the response rate to ICX-101 treatment using a patient-derived lung cancer cell model based on the level of myc expression.

ICX-101 showed a significant concentration-dependent inhibitory effect in vitro when administered to non-small cell lung cancer (NSCLC) overexpressing myc, and showed more than 50% improvement in anticancer effect compared to the positive control group in the final time zone. It is a drug that has been shown to have a clear inhibitory effect in direct analysis methods of interaction with Myc protein.

We confirmed the potential of ICX-101 as an effective targeted therapy for lung cancer and expect that it will become a critical treatment option for lung cancer patients who overexpress myc. ICX-101 can also be applied to various solid tumors and blood cancers, and a combination treatment strategy is also possible.

Dr. Jeong, the CEO of Incurix, stated, "We plan to strengthen our foundation for global market expansion by presenting our accumulated data at overseas academic conferences. We also plan to release data on other anti-cancer drug candidates early on to create an opportunity to promote the potential excellence of our pipeline externally."