Entry into a Material Definitive Agreement

On July 26, 2024, Aileron Therapeutics, Inc., a Delaware corporation (the "Company"), reported to have entered into an Equity Distribution Agreement (the "Agreement") with Citizens JMP Securities, LLC, as agent and/or principal (the "Agent"), pursuant to which the Company may offer and sell shares of its common stock, $0.001 par value per share, from time to time up to amounts to be determined through or to the Agent (the "Offering") (Filing, 8-K, Aileron Therapeutics, JUL 26, 2024, View Source [SID1234645102]). The Company filed a prospectus supplement with the Securities and Exchange Commission (the "SEC") to register shares of common stock having an aggregate offering price of up to $50,000,000 (the "Shares") in connection with the Offering (the "Prospectus Supplement") under the Company’s existing shelf Registration Statement on Form S-3 (File No. 333-265470) filed with the SEC on June 8, 2022, which became effective on June 16, 2022 (as it may be amended or supplemented, the "Registration Statement").

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Upon delivery of a placement notice to the Agent and subject to the terms and conditions of the Agreement, the Agent may sell the Shares in sales deemed to be "at the market offerings" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including sales made directly on or through the Nasdaq Capital Market.

The Company or the Agent may suspend or terminate the offering of Shares upon notice to the other party, subject to certain conditions. The Agent is not required to sell any specific amount of Shares, but will act as sales agent using commercially reasonable efforts consistent with its normal sales and trading practices and applicable state and federal law, rules and regulations and the rules of The Nasdaq Stock Market LLC.

The Company has agreed to pay the Agent commissions for its services of acting as agent of 3.0% of the gross proceeds from the sale of the Shares pursuant to the Agreement. The Company has also agreed to provide the Agent with customary indemnification and contribution rights with respect to certain liabilities.

A copy of the Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the material terms of the Agreement is qualified in its entirety by reference to such exhibit.

Wilmer Cutler Pickering Hale and Dorr LLP, counsel to the Company, has issued a legal opinion relating to the Shares. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

The Shares will be sold pursuant to the Registration Statement, and offerings of the Shares will be made only by means of the Prospectus Supplement. This Current Report on Form 8-K shall not constitute an offer to sell or solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such state or jurisdiction.

The RT2831 project of Regenecore officially obtained IND approval by FDA

On July 25, 2024 Nanjing RegeneCore Biotech reported the RT2831 project has officially obtained Investigational New Drug Application (IND) approval by FDA, USA (Press release, Nanjing RegeneCore Biotech, JUL 25, 2024, View Source [SID1234649773]). This is another major breakthrough for the Regenecore team in the field of tumor treatment after autoimmune diseases, and also the second IND approval for nanobody drugs obtained by the Regenecore team.

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Regenecore will continue to increase research and development investment, promote the RT2831 project to achieve more positive results in clinical research, and bring more blessings to cancer patients. At the same time, We will actively explore more innovative drugs and continue to move forward firmly on the path of "maintaining human health with excellent drugs".

H1 and Q2 2024 Results

On July 25, 2024 AstraZeneca the company reported its first half 2024 results (Presentation, AstraZeneca, JUL 25, 2024, View Source [SID1234647221]).

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Roche sales increase by 5% (CER) in first half of 2024; strong growth in second quarter – full-year earnings outlook raised

On July 25, 2024 Hoffmann-La Roche reported its sales increase by 5% (CER) in first half of 2024; strong growth in second quarter – full-year earnings outlook raised (Presentation, Hoffmann-La Roche, JUL 25, 2024, View Source [SID1234646007]).

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Ipsen delivers strong results in the first half of 2024, progresses on launches and upgrades its full-year guidance

On July 25, 2024 Ipsen, a global specialty-care biopharmaceutical company, reported its financial results for the first half of 2024 (Press release, Ipsen, JUL 25, 2024, View Source [SID1234645314]).

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Business highlights
» U.S. regulatory approvals and launches of Onivyde (irinotecan) in first-line pancreatic cancer and Iqirvo (elafibranor) in second-line primary biliary cholangitis, respectively
» In-licensing of tovorafenib outside the U.S.: an attractive addition to our Oncology pipeline
» Multiple early-stage external-innovation transactions across Oncology and Neuroscience

Financial highlights
» Total-sales growth of 9.5% at CER1 , or 8.0% as reported, driven by the performances of Cabometyx (cabozantinib) and Dysport (abobotulinumtoxinA), as well as contributions from Bylvay (odevixibat) and Onivyde
» Core operating margin of 32.4%, a decline of 1.6% points, driven mainly by enhanced R&D investment. An unchanged IFRS operating margin of 19.2%
» Upgraded 2024 financial guidance: total-sales growth greater than 7.0% at CER1 (prior guidance: greater than 6.0% at CER1 ); core operating margin greater than 30.0% of total sales (prior guidance: around 30%)