On June 22, 2022, Applied Therapeutics, Inc. (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with SVB Securities LLC (the "Underwriter"), relating to the issuance and sale pursuant to an underwritten public offering (the "Offering") of 20,000,000 shares (the "Shares") of its common stock, par value $0.0001 per share (the "Common Stock"), 10,000,000 pre-funded warrants to purchase Common Stock in lieu of Shares (the "Pre-Funded Warrants") at an exercise price of $0.0001 per share, and accompanying warrants to purchase up to 30,000,000 shares of its Common Stock (the "Common Warrants" and together with the Pre-Funded Warrants, the "Warrants") at an exercise price of $1.00 per share (the Shares and Warrants together, the "Securities") (Filing, 8-K, Applied Therapeutics, JUN 22, 2022, View Source [SID1234616309]). Each share of Common Stock and accompanying Common Warrant was sold at a public offering price of $1.00, less underwriting discounts and commissions, and each Pre-Funded Warrant and accompanying Common Warrant was sold at a public offering price of $0.9999, less underwriting discounts and commissions, as described in the prospectus supplement, dated June 22, 2022, filed with the Securities and Exchange Commission on June 24, 2022. The Pre-Funded Warrants and the Common Warrants are immediately exercisable and will expire five years from the date of issuance. Holders may not exercise any Pre-Funded Warrants or Common Warrants that would cause the aggregate number of shares of Common Stock beneficially owned by the holder to exceed 9.99% of the Company’s outstanding Common Stock immediately after exercise. Holders of the Warrants (together with affiliates) who immediately prior to the issue date beneficially own more than 9.99% of outstanding Common Stock may not exercise any portion of their Pre-Funded Warrants or Common Warrants if the holder (together with affiliates) would beneficially own more than 19.99% of the Company’s outstanding Common Stock after exercise. The Warrants are subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock and also upon any distributions for no consideration of assets to the Company’s stockholders. In the event of certain corporate transactions, the holders of the Warrants will be entitled to receive, upon exercise of the Warrants, the kind and amount of securities, cash or other property that the holders would have received had they exercised the Warrants immediately prior to such transaction. The Warrants do not entitle the holders thereof to any voting rights or any of the other rights or privileges to which holders of Common Stock are entitled. The Company intends to use the net proceeds from this Offering for general corporate purposes. General corporate purposes may include research and development costs, including the conduct of clinical trials and process development and manufacturing of the Company’s product candidates, expansion of the Company’s research and development capabilities, working capital and capital expenditures. Entities affiliated with Alexandria Venture Investments, LLC, which, as of March 31, 2022, owned 13.1% of the Company’s outstanding Common Stock, purchased 3,500,000 shares and 1,500,000 Pre-Funded Warrants in the Offering.

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The Offering closed on June 27, 2022.

On June 22, 2022 OCTALFA reported that its subsidiary ORPHELIA Pharma, the French biopharmaceutical company dedicated to the development and commercialization of orphan medicines for the treatment of rare and pediatric diseases, has included the first patient in the KIMOZO French Early Access Program for the treatment of relapsed or refractory neuroblastoma (Press release, ORPHELIA Pharma, JUN 22, 2022, View Source;utm_medium=rss&utm_campaign=octalfa-announces-the-inclusion-of-the-first-patient-in-the-french-early-access-program-granted-to-its-subsidiary-orphelia-pharma-for-the-use-of-kimozo-40-mg-ml-temozolomide-oral-suspension-in [SID1234616508]).

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KIMOZO 40 mg/ml (oral suspension of temozolomide) was granted an early access pre-marketing authorization (Autorisation d’Accès Précoce, AAP) in France on March 31st, 2022 by the Haute Autorité de Santé (HAS) for the treatment of relapsed or refractory neuroblastoma in patients aged 1 to 6 years as well as patients unable to swallow temozolomide capsules.

The goal of Early Access Programs in France is to accelerate access to innovative drugs before or after Market Authorization is granted once all conditions specified in Article L.5121-12 of the French Public Health Code (Code de la Santé Publique) are met:

No appropriate treatment exists;
The treatment’s implementation cannot be postponed;
The efficacy and safety of these drugs are strongly presumed based on therapeutic trials;
These drugs are considered to be innovative, particularly when compared to a possible clinically-relevant comparator.
Full details of the early access program can be found at the Haute Autorité de Santé and the ANSM websites.

About KIMOZO 40 mg/ml

KIMOZO 40 mg/ml is a liquid, taste-masked and ready-to-use oral formulation of temozolomide developed to treat rare pediatric cancers.

In France, KIMOZO has been granted an Early Access Program, to be used as monotherapy or in combination with irinotecan or topotecan in the treatment of pediatric patients aged 1 to 6 years and in patients with incapacity to swallow capsules of temozolomide and who suffer from:

refractory high-risk neuroblastoma or presenting an insufficient response to induction chemotherapy;
relapsed high-risk neuroblastoma after at least a partial response to induction chemotherapy followed by myeloablative therapy and stem cell transplantation.
KIMOZO was developed by ORPHELIA Pharma in collaboration with Gustave Roussy.

On June 22, 2022 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported that Tanya Urbach, Board Chair, Antonio Migliarese, Chief Financial Officer and Interim President, Scott Kelly, Chief Medical Officer and Head of Business Development, and Christopher Recknor, M.D., Senior Director of Research & Development, will host an investment community webcast to provide a quarterly Company update on Thursday, June 30, 2022 (Press release, CytoDyn, JUN 22, 2022, View Source [SID1234616173]).

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Following the update, questions submitted prior to the webcast as directed below will be addressed to the extent appropriate.

This is a livestream presentation. Participants are encouraged to login early prior to the start of the event. The replay will be available approximately 60 minutes after the conclusion of the webcast and can be accessed via the above link until July 30, 2022.

On June 22, 2022 Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for EP0031, a next generation selective RET inhibitor (SRI) (Press release, Ellipses Pharma, JUN 22, 2022, View Source [SID1234616189]).

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Developed in partnership with Sichuan Kelun-Biotech Pharmaceutical Co., Ltd (Kelun-Biotech), EP0031 (known as A400 when in conjunction with Kelun-Biotech’s ongoing regional development) is a next generation SRI under development for the treatment of RET-altered cancers, with the first trials to focus on thyroid and non-small cell lung cancer. Kelun-Biotech has already commenced a clinical trial of EP0031 (A400) in China, which is progressing rapidly towards the dose expansion stage.

Approval of the IND is a significant step in the initiation of a global, modular Phase 1/2 trial to evaluate the safety, tolerability and efficacy of EP0031 in patients with advanced RET-altered cancers including patients who have not received prior treatment with first generation SRIs. The trial will include sites across the US and Europe and the first patient is anticipated to enter the dose escalation part of the trial in Q3 2022. Further regulatory submissions in the UK and EU are anticipated shortly to support the initiation of the trial in countries outside of the US.

Dr Rajan Jethwa, Chief Executive Officer & Founder of Ellipses, commented:
"EP0031 offers the potential for a promising new treatment option that seeks to address some of the issues with first generation SRIs. Next generation SRIs offer the potential to expand the armamentarium against RET-driven cancers and further improve patient outcomes. This IND marks another important step for Ellipses. Our strategy is to advance the most promising cancer treatments to the clinic as soon as possible, and the clearance of this IND will allow us to rapidly move forward with our planned clinical trial of EP0031."

ENDS

About EP0031 (A400)
EP0031 is a potent next generation SRI with broad activity against common RET fusions and mutations, including solvent front resistance mutations. Therefore, EP0031 (A400) may overcome resistance mechanisms to first generation SRIs. In preclinical studies, EP0031 (A400) demonstrated favourable inhibitory activity against key RET kinases in-vitro and in-vivo. EP0031 (A400) also demonstrated good penetration of the blood brain barrier in animal models. An IND application for EP0031 (A400) was approved by China’s National Medicinal Products Administration (NMPA) in June 2021 and a Phase 1/2 trial is ongoing in China. In March 2021, Kelun-Biotech granted Ellipses an exclusive license for EP0031 (A400) in certain territories including the US and Europe, with Kelun-Biotech retaining certain rights in Greater China and part of the Asia-Pacific region.

On June 22, 2022 Angiex, developer of Nuclear-Delivered Antibody-Drug Conjugate (ND-ADC) therapies for solid cancers, reported that has appointed Marty J. Duvall as chief executive officer and member of its board of directors (Press release, Angiex, JUN 22, 2022, View Source [SID1234616158]).

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Duvall brings extensive global oncology drug development and commercialization experiences from executive leadership roles in both large pharmaceutical and biotech companies. At companies that include Aventis, Merck, MGI, and ARIAD, he built successful oncology companies with a footprint across the US, Europe, and Asia. With an oncology focus over the last three decades, Duvall has helped launch and drive many successful therapeutics that have benefited patients with a wide range of cancers, including breast, lung, prostate, gastric, head and neck, brain, melanoma, myelodysplastic syndrome, leukemia, and multiple myeloma.

Angiex Founder and President, Paul Jaminet, said, "Marty joins the Angiex team at the perfect time to help drive our company forward. Together with our scientific team of leading experts in angiogenesis, vascular biology, antibody-drug conjugate chemistry, and oncology, Marty will help fully realize the promise of our transformative biology and ND-ADC technology."

"I couldn’t be more excited to join Angiex at this stage in the company’s young history. We have the opportunity to do something special here as we build on the exciting clinical results of the antibody-drug conjugate class," said Marty J. Duvall. "Our pre-clinical data is impressive, our potential to improve efficacy and therapeutic margin compared to traditional ADCs is clear, and we are now moving AGX101, our lead ND-ADC product, into clinical development."

Iain Dukes, executive chairman of Angiex and venture partner of Orbimed Advisors, said, "Bringing in an executive of Marty’s caliber is an important step for Angiex. AGX101and future drugs built on Angiex’s platform have the potential to transform the way cancer is treated, and Marty has the experience help make that happen."