On September 30, 2023 BroadenBio reported that it has received approvals from CDE and FDA in September 2023, for the Investigational New Drug (IND) Application of conducting clinical trials on advanced solid tumors of BB3008 (Press release, BroadenBio, SEP 30, 2023, View Source [SID1234640205]).

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Hematopoietic progenitor kinase 1 (HPK1), also known as MAP4K1, is a serine/threonine kinase mainly expressed in immune cells (T cells, B cells, dendritic cells, macrophages, and etc.). HPK1 is a key negative feedback regulator of the T cell receptor (TCR) signaling pathway. As an important intracellular immune checkpoint, HPK1 inhibits the proliferation and functions of T cells and B cells, and also inhibits the antigen presentation by dendritic cells (DCs). Clinical studies have observed upregulation of HPK1 levels in various tumor tissues such as leukemia, bladder cancer, breast cancer, and colon cancer. HPK1 inhibition can restore the immunology functions in tumor microenvironment and enhance T cell-mediated anti-tumor immune effects. Therefore, HPK1 is a potential target for immuno-oncology therapy.

BB3008 is a highly selective small molecule inhibitor of HPK1 with novel molecular structure developed independently by BroadenBio. BB3008 significantly activates T cell activity in vitro, shows pronounced tumor growth inhibition both as monotherapy and in combination with PD-1 inhibitors, and has excellent pharmacokinetics properties and controllable safety. The preclinical study of BB3008 was been published as "Late-Breaking Research" at the 2023 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). BB3008, as monotherapy or in combination, will be used to overcome the immune suppressive tumor microenvironment and treat malignant solid tumors in clinical trials.

On September 29, 2023 Molecure S.A., a clinical stage biotechnology company developing first-in-class small molecule drug candidates that directly modulate unexplored protein and RNA targets to treat multiple incurable diseases reported first half results for the period ended 30 June 2023 (Press release, Molecure, SEP 29, 2023, View Source [SID1234640060]). The full report in Polish can be found here.

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Marcin Szumowski, CEO and President of the Management Board of Molecure said "Many events of this year were crucial for further development of Molecure. In June, we announced the updated strategy for 2023-2025, the implementation of which will enable us to continue building the company’s value. In a very difficult market for biotech, attracting investor interest leading to high oversubscription in our secondary public offering was clearly a great accomplishment in our quest to build a clinical stage biotechnology company able to change the fate of patients. This year we have made excellent progress developing our first in class product portfolio and have achieved key milestones throughout this year including dosing the first cancer patient in our Phase 1 study with OATD-02, and receiving FDA approval to proceed with clinical trials in the US for OATD-01.

Bringing two of our most advanced programs to patients opened a new and exciting chapter for Molecure. I would like to thank our shareholders for their trust and the entire Molecure team for their dedication and unwavering commitment to improving the lives of patients. We eagerly await the initial read outs from our clinical trials and look forward to achieving further milestones in the development of our balanced pipeline, which we hope will ultimately lead to commercial success through strategic partnership agreements."

Investor Presentation

The Company’s first half results presentation for investors will be held on October 3, 2023 at 2:00 PM (CET) in an online meeting. Link View Source

The meeting will be conducted mainly in Polish and partly in English with simultaneous translation. It is expected to last approximately 90 minutes.

Commercial & Operational Highlights in H1 and post-period

Significant progress made on OATD-02, an oral, potent and selective first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer
First patient dosed in March 2023 in Phase I clinical trial to assess safety, tolerability and preliminary efficacy of OATD-02 in patients with advanced and/or metastatic solid tumors
lnitial clinical data expected at the end of 2023
Publication in Molecular Cancer Therapeutics, a journal of the American Association of Cancer Research, entitled "Arginase 1/2 inhibitor OATD-02: from discovery to first-in-man setup in cancer immunotherapy". Link here
In June, the publication of an update to the Strategy for the years 2023-2025. The Company’s primary strategic objectives in the areas of R&D and business development are:
– Continuation of the intensive clinical development of two key projects: completion of the Phase II study for OATD-01 in sarcoidosis and completion of the Phase I clinical trial for OATD-02 involving oncology patients, with the potential for expanding into additional indications and combination therapies,

– Further advancement of early-stage preclinical projects, including the identification of 1-2 lead compounds (candidates for preclinical development) and the initiation of another program into the clinical trial phase,

– Acceleration of the development of a groundbreaking small molecule drug platform targeting mRNA, including achieving in vitro Proof of Concept (PoC) and selecting lead molecules.

– Enhancement of the drug discovery processes efficiency (by reducing time and costs and mitigating the risk of failure) through investments in machine learning technology and generative artificial intelligence (GenAI),

– Execution of at least 1 high value partnering agreement for at least one project in the clinical phase, as well as the establishment of a series of commercial collaborations, including profit-sharing arrangements, for programs in earlier stages of development,

The total investment expenditure to achieve the goals outlined in the Strategy for the period from mid-2023 to the end of 2025 has been estimated at approximately PLN 250 m.

In July, Molecure successfully raised, through a Secondary Public Offering, gross proceeds of approximately PLN50m (USD12m) from existing shareholders,
– These proceeds and expected grant awards will be used to fund and build Molecure’s first in class sustainable pipeline of breakthrough therapies through significant value inflection points including completion of the Phase II study for OATD-01 in sarcoidosis and completion of the Phase I clinical trial for OATD-02 in oncology patients, with the possibility of expansion into additional indications and combination therapies.

We continue to make excellent progress with OATD-01:
– In July Molecure, received US FDA Investigational New Drug (IND) approval for OATD-01 which will allow the company to conduct Phase II clinical trials in the US. The planned Phase II proof-of-concept study will be the first to treat patients suffering from pulmonary sarcoidosis and is expected to start in the fourth quarter 2023.

– Molecure has also submitted applications to the EMA and UK MHRA to initiate a Phase II clinical trial in the European Union and Norway and the UK respectively.

Molecure has signed an agreement with Simbec-Orion, a leading global Clinical Research Organisation which will conduct the clinical trial on behalf of Molecure. The Phase II trial will be conducted in the US and several European Union Countries and enroll approximately 90 patients with active pulmonary sarcoidosis.

Key organizational changes to drive the Company through its next phase of growth and clinical development

Samson Fung, Chief Medical Officer appointed to the Company’s Management Board to support the clinical development of OATD-01 and OATD-02
Zbigniew Zasłona, promoted to Chief Scientific Officer from his former position as VP Research Biology. Dr. Zasłona, remains on Molecure’s Management Board

First Half Financial Highlights

Operating income of PLN1.0 million, in line with 1H 2022.
Operating expenses totaled PLN10.9 million, an increase of PLN2.2 million. This was mainly due to increasing research costs as the company’s pipeline advances, higher salaries and costs of external services.
Net loss for the first six months of the year totaled PLN7.4 million vs net loss of PLN7.1 million in 1H 2022.
As of June 30, 2023, Molecure had cash of nearly PLN 50million (US$11.5 million).
As of the publication date of the 1H 2023 report (September 29), the Company’s cash position amounted to approximately 85 million PLN, taking into account the funds raised from the recently finalized public offering (US$19.5 million).
US$/PLN exchange rate 4.35 as of 30 June 2023.

On September 29, 2023 Veru Inc. (the "Company") reported that the company entered into an Amendment to Asset Purchase Agreement (the "Amendment ") with Blue Water Biotech Inc. f/k/a Blue Water Vaccines Inc. (the "Purchaser") (Filing, 8-K, Veru, SEP 29, 2023, View Source [SID1234635571]). The Amendment amends the Asset Purchase Agreement, dated as of April 19, 2023 (the "Asset Purchase Agreement"), between the Company and the Purchaser by providing that the promissory note for the $4 million installment of the purchase price due September 30, 2023, will be deemed paid and fully satisfied upon (1) the payment to the Company of the sum of $1,000,000 in immediately available funds on September 29, 2023, and (2) the issuance to the Company by October 3, 2023 of 3,000 shares of Series A Convertible Preferred Stock (the "Series A Preferred Stock") of the Purchaser. The Company received such $1,000,000 payment on September 29, 2023.

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The terms of the Series A Purchaser Preferred Stock are governed by a Certificate of Designations filed with the Delaware Secretary of State by the Purchaser on September 29, 2023. Pursuant to the Certificate of Designations, each share of Series A Preferred Stock is convertible by the Company at any time and from time to time from and after one year from the date of issuance of the Series A Preferred Stock into that number of shares of the Purchaser’s common stock determined by dividing the Stated Value of $1,000 per share by the Conversion Price of $0.5254 per share, subject to adjustment as provided in the Certificate of Designations. The Series A Preferred Stock issued to the Company is initially convertible into an aggregate of approximately 5,709,935 shares of the Purchaser’s common stock, subject to certain shareholder approval limitations specified in the Certificate of Designations. The Purchaser has agreed in the Amendment to use commercially reasonable efforts to obtain such shareholder approval by December 31, 2023. The Series A Preferred Stock is entitled to share ratably in any dividends paid on the Purchaser’s common stock (on an as-if-converted-to-common-stock basis), has no voting rights except as to certain significant matters specified in the Certificate of Designations, and has a liquidation preference equal to the Stated Value of $1,000 per share plus any accrued but unpaid dividends thereon. The Series A Preferred Stock is redeemable in whole or in part at the Purchaser’s option at any time. The Purchaser also agreed to include the shares of common stock issuable upon conversion of the Series A Preferred Stock in the next resale registration statement filed with the Securities and Exchange Commission.

There can be no assurance as to (1) whether and when the Company will receive the future installment payments of purchase price or sales milestone payments under the Asset Purchase Agreement and the extent of the risk of a future default by the Purchaser in performing its payment obligations, (2) the ability of the Purchaser to obtain the requisite approval of its shareholders to the conversion of all of the shares of Series A Preferred Stock, and (3) whether and when the Company will be able to receive any cash proceeds from the Series A Preferred Stock, whether from sales of shares of the Purchaser’s common stock issuable upon conversion of the Series A Preferred Stock or otherwise, and the amount of any such cash proceeds.

The description of the Amendment (including the Certificate of Designations) set forth herein is qualified in its entirety by reference to the full text of the Amendment (including the Certificate of Designations), a copy of which is attached as Exhibit 10.1 hereto and incorporated by reference herein.

On September 29, 2023 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, reported that it has granted equity awards on September 29, 2023 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 24 individuals hired by Sarepta in September 2023 (Press release, Sarepta Therapeutics, SEP 29, 2023, View Source [SID1234635555]). The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

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The employees received, in the aggregate, options to purchase 16,575 shares of Sarepta’s common stock, and in the aggregate 8,575 restricted stock units ("RSUs"). The options have an exercise price of $121.22 per share, which is equal to the closing price of Sarepta’s common stock on September 29, 2023 (the "Grant Date"). One-fourth of the shares underlying each employee’s option will vest on the one-year anniversary of the Grant Date and thereafter 1/48th of the shares underlying each employee’s option will vest monthly, such that the shares underlying the option granted to each employee will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to each such employee’s continued employment with Sarepta on such vesting dates.

One-fourth of the RSUs will vest yearly on each anniversary of the Grant Date, such that the RSUs granted to each employee will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to each such employee’s continued employment with Sarepta on such vesting date.

On September 29, 2023 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported that it granted inducement awards on September 29, 2023 (Press release, Adicet Bio, SEP 29, 2023, View Source [SID1234635554]).

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Four individuals were hired by Adicet in September 2023. In the aggregate, Adicet granted new hires non-qualified stock options to purchase 32,200 shares of Adicet’s common stock with an exercise price of $1.37 per share, the closing price of Adicet’s common stock as reported by Nasdaq on September 29, 2023. One-fourth of the shares underlying each employee’s option will vest on the one-year anniversary of each recipient’s start date and thereafter the remaining three-fourths of the shares underlying each employee’s option will vest in thirty-six substantially equal monthly installments, such that the shares underlying the option granted to each employee will be fully vested on the fourth anniversary of the recipient’s start date, in each case, subject to each such employee’s continued employment with Adicet on such vesting dates.

All of the above-described awards were granted outside of Adicet’s stockholder-approved equity incentive plans pursuant to Adicet’s 2022 Inducement Plan (the Inducement Plan), which was adopted by the board of directors in January 2022 and subsequently amended in January 2023. The awards were authorized by the compensation committee of the board of directors, which is comprised solely of independent directors, as a material inducement to the employees entering into employment with Adicet in accordance with Nasdaq Listing Rule 5635(c)(4).