On January 24, 2024 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that it has agreed to sell 1,376,813 shares of its common stock at a price of $17.25 per share, representing a premium of approximately 29% to Kura’s closing price on January 23, 2024, and pre-funded warrants to purchase 7,318,886 shares of its common stock at price per pre-funded warrant of $17.2499 to a select group of institutional and accredited healthcare specialist investors in an oversubscribed private placement (Press release, Kura Oncology, JAN 24, 2024, View Source [SID1234639450]). The pre-funded warrant exercise price is $0.0001 per share. Kura anticipates the gross proceeds from the private placement to be approximately $150 million, before deducting any offering-related expenses. The private placement is expected to close on or about January 26, 2024, subject to customary closing conditions.

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The financing includes participation from existing institutional investors, including EcoR1 Capital, an affiliate of Deerfield Management and Suvretta Capital. Leerink Partners acted as the sole placement agent for the private placement.

Kura intends to use the net proceeds from the proposed financing to fund research and development of its clinical-stage product candidates, other research programs, working capital and general corporate purposes. The proceeds from this financing, combined with current cash, cash equivalents and investments, are expected to fund current operations into 2027.

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Kura has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock issued in the private placement and the shares of common stock issuable upon the exercise of the pre-funded warrants issued in the private placement no later than the 30th day after the pricing of the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

Virtual Investor Event

Kura will host a virtual investor event featuring company management and investigators from the KOMET-007 trial of ziftomenib in combination with standards of care at 8:00 a.m. ET on Tuesday, January 30, 2024. The event will be webcast live and can be accessed on the Investors section of Kura’s website at www.kuraoncology.com. An archived replay will be available shortly after the conclusion of the live event.

On January 24, 2024 Amphista Therapeutics ("the Company" or "Amphista"), a leader in next generation targeted protein degradation (TPD) approaches, reported the achievement of two compelling new data sets with its next generation bifunctional degraders demonstrating in vivo efficacy and the ability to target and degrade proteins in the central nervous system (CNS) (Press release, Amphista Therapeutics, JAN 24, 2024, View Source [SID1234639449]).

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Amphista’s degraders, which leverage a novel protein degrading mechanism, with advantages beyond first generation cereblon or VHL-based approaches, have demonstrated:

Sustained degradation of target protein and anti-tumor efficacy: once daily oral dosing led to statistically significant reduction in tumor burden and survival advantage in multiple in vivo disease models.
Rapid degradation of target protein: significant levels of degradation were induced rapidly after dosing.
Highly selective degradation of target protein: statistically significant degradation of target protein vs >8000 other proteins, including closely related homologs, when dosed at 100x DC50.
Amphista also discloses significant progress in the advancement of its technology for the treatment of neurodegenerative diseases, a key focus of the Company. These data show:

Amphista degraders can be rationally designed to achieve CNS penetrance with examples achieved across multiple targets.
Rapid degradation of target protein achieved in the brain in vivo (dog and non-human primate, and in multiple brain regions) when dosed intravenously.
Louise Modis, Chief Scientific Officer of Amphista Therapeutics, said: "We are delighted by the progress we have made in advancing our pipeline and demonstrating the potential of our unique TPD technology. To our knowledge, this is the first time an orally delivered bifunctional non-cereblon / non-VHL-based protein degrader has shown efficacy in disease-relevant in vivo models. Combined with our progress in demonstrating in vivo degradation of targets within the CNS, we are extremely excited to have achieved these key preclinical development milestones and we look forward to providing additional updates across our pipeline throughout the year."

Beverley Carr, Interim Chief Executive Officer of Amphista Therapeutics, said: "The last six months have been transformative for Amphista and these new compelling in vivo data strengthen our belief that our technology has the potential to deliver differentiated protein degrader molecules with class-leading physicochemical properties, enabling us to target a wider tissue and indication scope than traditional protein degrader approaches. These data are testament to the strength of our scientific team and we are on track with our portfolio priorities, exploring the tremendous potential of our platform across multiple indications in CNS and oncology."

On January 24, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that it has received authorization from the Erasmus Medical Center ("Erasmus MC") Ethics Committee to open a European site for the ongoing Phase 2 study ("AMP-270") of Ampligen as a therapy for locally advanced pancreatic cancer (Press release, AIM ImmunoTech, JAN 24, 2024, View Source [SID1234639448]).

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"Approval from the governing ethics board is an important step toward enrolling subjects in the European arm of the AMP-270 clinical trial for locally advanced pancreatic cancer," stated Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC in the Netherlands. "Erasmus MC is tracking several cancer patients that we are hopeful will be enrolled in AMP-270."

AMP-270 is a randomized, open-label, controlled, parallel-arm clinical trial with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. AMP-270 is expected to enroll approximately 90 subjects in the United States and Europe.

For more information about AMP-270, please visit ClinicalTrials.gov and reference identifier NCT05494697.

On January 24, 2024 Abbott reported financial results for the fourth quarter ended Dec. 31, 2023 (Press release, Abbott, JAN 24, 2024, View Source [SID1234639447]).

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Fourth-quarter sales increased 1.5 percent on a reported basis, 2.1 percent on an organic basis, and 11.0 percent on an organic basis, excluding COVID-19 testing-related sales1.
Fourth-quarter GAAP diluted EPS of $0.91 and adjusted diluted EPS of $1.19, which excludes specified items.
Abbott issues full-year 2024 guidance for diluted EPS on a GAAP basis of $3.20 to $3.40 and full-year adjusted diluted EPS of $4.50 to $4.70.
Abbott projects full-year 2024 organic sales growth, excluding COVID-19 testing-related sales, to be in the range of 8.0% to 10.0%2.
In 2023, Abbott continued to recapture market share in the U.S. infant formula market. The company has now reclaimed its previous market-leading position, as measured on a volume basis.
In December, Abbott announced U.S. Food and Drug Administration (FDA) approval of its new laboratory automation system, GLP systems Track, to help laboratories optimize performance and safety to better meet the growing demand for diagnostic testing.
In January, Abbott announced that the first-in-human procedures were conducted using the company’s new Volt Pulsed Field Ablation (PFA) System to treat patients with heart rhythm disorders such as atrial fibrillation (AFib). These procedures were part of Abbott’s Volt CE Mark clinical study. Abbott anticipates approval for its U.S. clinical trial (IDE) for the Volt PFA System in the first half of 2024.
In January, Abbott announced that Tandem Diabetes Care’s t:slim X23 insulin pump is the first automated insulin delivery system in the U.S. to integrate with Abbott’s new FreeStyle Libre 2 Plus sensor.
"The strength and diversity of the Abbott portfolio drove our success in 2023," said Robert B. Ford, chairman and chief executive officer, Abbott. "We’re entering 2024 with a lot of positive momentum, and with our highly productive pipeline, we’re well-positioned for growth in 2024 and beyond."

FOURTH-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange, the impact of exiting the pediatric nutrition business in China, and the impact of the acquisition of Cardiovascular Systems, Inc. (CSI), 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 has shifted to an endemic state, resulting in significantly lower 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.

On January 23, 2024 Johnson & Johnson reported fourth quarter and Full-Year 2023 Results (Press release, Johnson & Johnson, JAN 23, 2024, View Source [SID1234639453]).

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