Kinnate Biopharma Inc. Announces Acquisition of Ownership Stake from Series A Investors of the China Joint Venture, Kinnjiu Biopharma Inc., and Initiation of Phase 1 Clinical Trial for Exarafenib (KIN-2787) in People’s Republic of China

On February 21, 2023 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported that it has acquired ownership stake of Kinnjiu Biopharma Inc. ("Kinnjiu") previously held by the Series A investors using a combination of Kinnate shares and cash (Press release, Kinnate Biopharma, FEB 21, 2023, View Source [SID1234627465]). Kinnate retains Kinnjiu’s cash, intellectual property and other assets, including key personnel and the legal entity structure. The transaction does not impact Kinnate’s cash runway, with current cash, cash equivalents and investments expected to fund current operations into mid-2024. The company also announced that KN-8701, a Phase 1 clinical trial evaluating its pan-RAF inhibitor, exarafenib, was initiated in the People’s Republic of China (PRC), with trial sites now open in PRC and Taiwan.

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Nima Farzan, chief executive officer, Kinnate Biopharma Inc., commented, "We believe retaining the Kinnjiu structure will enable Kinnate to continue to invest in innovation and clinical development of its kinase inhibitors in the People’s Republic of China, Hong Kong, Macau and Taiwan. We are pleased with the progress to date across our programs, including initiating our Phase 1 clinical trial for exarafenib in the region, with sites now open in People’s Republic of China and Taiwan, and initiating the Phase 1 trial for KIN-3248, our pan-FGFR inhibitor, in Taiwan. We plan to continue advancing our novel targeted oncology pipeline globally."

Transaction Background and Terms

Kinnjiu was formed in 2021 as part of Kinnate’s joint venture to develop and commercialize its most advanced kinase inhibitors in the PRC, Hong Kong, Macau and Taiwan. In the transaction, Kinnate purchased all issued and outstanding Series A preferred shares of Kinnjiu from funds affiliated with OrbiMed and Foresite Capital Management for $24 million, using a combination of cash and shares of common stock of Kinnate. The transaction was approved by the independent directors of Kinnate.

KN-8701 Clinical Trial Background

KN-8701 is an ongoing, global Phase 1 clinical trial (NCT04913285) evaluating exarafenib in patients with advanced solid tumors harboring BRAF Class I, II and III alterations, and/or who have NRAS mutant melanoma. The trial is enrolling patients at more than 30 sites across the globe. KN-8701 contains a two-part dose escalation: in Part A1, exarafenib is being evaluated as a monotherapy across BRAF alterations and tumor types and Part A2 is evaluating exarafenib in combination with binimetinib, a MEK inhibitor. Part B, dose expansion, will evaluate exarafenib at a selected dose in cancers driven by BRAF Class II or Class III alterations.

VolitionRx Limited Announces Proposed Underwritten Public Offering of Common Stock

On February 21, 2023 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition" or the "Company"), a multi-national epigenetics company, reported that it has commenced an underwritten public offering of shares of its common stock. In addition, Volition intends to grant the underwriter a 30-day option to purchase up to an additional 15% of the number of shares of common stock offered in the offering at the public offering price, less underwriting discounts and commissions (Press release, VolitionRX, FEB 21, 2023, View Source [SID1234627469]). All of the shares of common stock in the offering are being offered by Volition. The final terms of the proposed offering will depend on market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Volition intends to use the net proceeds from the offering for research and continued product development, clinical studies, product commercialization, working capital and other general corporate purposes, including potential strategic acquisitions.
Newbridge Securities Corporation is acting as the sole book-running manager of the offering.

The securities are being offered by Volition pursuant to a "shelf" registration statement on Form S-3 (File No. 333-259783) previously filed with the Securities and Exchange Commission (the "SEC") on September 24, 2021, as amended on November 4, 2021, and declared effective by the SEC on November 8, 2021. The offering is being made only by means of a prospectus supplement and an accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that the Company may file with the SEC. A preliminary prospectus supplement and an accompanying base prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. The final prospectus supplement relating to the offering will be filed with the SEC and will also be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement, the final prospectus supplement and the accompanying base prospectus relating to the offering can also be obtained, when available, from Newbridge Securities Corporation, Attn: Equity Syndicate Department, 1200 North Federal Highway, Suite 400, Boca Raton, FL 33432, by email at [email protected], or by telephone at (877) 447-9625.

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 sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Entry into a Material Definitive Agreement.

On February 21, 2023 Propanc Biopharma, Inc. (the "Company"), reported that it has entered into a securities purchase agreement (the "Purchase Agreement") with ONE44 Capital LLC ("ONE44"), pursuant to which ONE44 purchased a convertible promissory note (the "Note") from the Company in the aggregate principal amount of $111,111, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of ONE44 (Filing, 8-K, Propanc, FEB 21, 2023, View Source [SID1234627467]). The transaction contemplated by the Purchase Agreement closed on February 16, 2023. The Company intends to use the net proceeds ($100,000) from the Note for general working capital purposes. The Note contains an original issue discount amount of $11,111.

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The maturity date of the Note is February 14, 2024 (the "Maturity Date"). The Note bears interest at a rate of 10% per annum. Interest is payable only in shares of Company’s common stock (the "Common Stock") and is due and payable only contemporaneously with a payment of principal, whether at the Maturity Date or upon acceleration or by prepayment, as described below. ONE44 is entitled, at its option, at any time after the six-month anniversary of the Note, to convert all or any amount of the principal face amount of this Note then outstanding into shares of Common Stock at a per-share price equal to 60% of the lowest trading price of the Common Stock, as reported by the OTC Markets Group (if the shares of the Common Stock are then quoted thereon) or by any securities exchange upon which the Common Stock is then listed, for the ten prior trading days including the day upon which a Notice of Conversion is received by the Company. In the event the Company experiences a DTC "Chill" on its shares, the conversion price shall then be decreased to 50% instead of 60% while that "Chill" is in effect. Notwithstanding the foregoing, ONE44 shall be restricted from effecting a conversion if such conversion, along with other shares of Common Stock then beneficially owned by ONE44 and its affiliates, exceeds 4.99% of the outstanding shares of Common Stock (which may be increased up to 9.9% of the outstanding shares of Common Stock upon 60 days’ prior written notice by ONE44 to the Company).

The Company may prepay the principal of the Note and accrued interest until 180 days from the issuance date (August 13, 2023). If the Note is prepaid within 60 days of the issuance date (April 15, 2023), then the prepayment premium shall be 120% of the face amount plus any accrued interest. If the Note is prepaid after 60 days from the issuance date, but less than 120 days from the issuance date (June 14, 2023), then the prepayment premium shall be 130% of the face amount plus any accrued interest. If the Note is prepaid after 120 days from the issuance date, up to 180 days from the issuance date (August 13, 2023), then the prepayment premium shall be 135% of the face amount plus any accrued interest. So long as the Note is outstanding, the Company covenants not to, without prior written consent from ONE44, sell, lease or otherwise dispose of all or substantially all of its assets outside the ordinary course of business which would render the Company a "shell company" as such term is defined in Rule 144.

Other than as described above, the Note contains certain events of default, including failure to issue shares timely upon receipt of a notice of conversion, as well as certain customary events of default, including, among others, breach of covenants, representations, or warranties, insolvency, bankruptcy, liquidation, and failure by the Company to pay the principal and interest due under the Note. Upon the occurrence and during the continuation of certain events of default, the Note will accrue an annual interest rate of 24% or, if such rate is usurious or not permitted by current law, then at the highest rate of interest permitted by law.

The Note was issued, and any shares of Common Stock to be issued pursuant to any conversion of the Note shall be issued, in a private placement in reliance upon an exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.

The foregoing descriptions of the Note and the Purchase Agreement do not purport to be complete and each is qualified in its entirety by reference to the full text of the Note and the Purchase Agreement, which are filed as Exhibits 4.20 and 10.41, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

PDX Pharma awarded two-year $1.87M phase II SBIR grant from the National Cancer Institute (NCI) for the development of ARAC-02, a novel lung cancer treatment

On February 21, 2023 PDX Pharma reported that it has been awarded a phase II SBIR grant of $1.87M for 2 years from the National Cancer Institute (NCI) focusing on the development of a new nano-immunotherapy ARAC-02 (Antigen Release Agent and Checkpoint Inhibitor) for lung cancer treatment (Press release, PDX Pharmaceuticals, FEB 21, 2023, View Source [SID1234627466]). ARAC-02 – nanoparticle co-delivering a PD-L1 antibody, a polo-like kinase 1 (PLK1) inhibitor, and an immune-stimulant CpG – provides effective antitumor immune response via CD8+ T cell activities. The original grant application of ARAC-02 had high merit and received a rare perfect score from the NIH. We met all phase I SBIR milestones on formulation optimization and initial efficacy and safety studies in cells and in mice, which leads to phase II SBIR grant awarded for ARAC-02’s evaluation in multiple lung cancer models. Many cancers including lung cancer depend on PLK1 for cell division and growth, and PLK1 inhibition by ARAC-02 will lead to cell death. After PLK1 inhibition, ARAC-02 transiently upregulates PD-L1 expression, rendering the cancer (which may originally have low PD-L1 expression and are not eligible for immune checkpoint inhibitors, ICIs) more sensitive to PD-L1 antibody serving as the ICI and cancer homing agent on ARAC-02. We also show that CpG on ARAC-02, which recruits and activates antigen-presenting cells, enhance CD8+ T cell population and activities. Our current data suggest that ARAC-02 will have broad efficacy in lung and other cancer types (e.g., breast, liver, and pancreatic cancer) regardless of mutational status. ARAC-02 is anticipated to reach clinical trials next year. Data on first gen ARAC (without CpG) was published in Nature Communications in 2022. A US patent (US11224573B2) on the ARAC technology was also issued in Jan, 2022.

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Entry into a Material Definitive Agreement

On February 21, 2023 iBio CDMO LLC, a wholly owned subsidiary of iBio, Inc. (the "Company") and Woodforest National Bank ("Woodforest") reported that it has entered into the Second Amendment to the Credit Agreement that was entered into on November 1, 2021, as amended (the "Credit Agreement"), which amendment, among other things, added a milestone that had to be met by a specified date, the failure of which would be an event of default (Filing, 8-K, iBioPharma, FEB 21, 2023, View Source [SID1234627464]). In addition, on February 9, 2023, the Company, as guarantor, entered into the Second Amendment to the Guaranty, which was executed on November 1, 2021, as amended (the "Guaranty"), which amendment, among other things, allows the Company to account for all amounts owed to it by Fraunhofer USA Inc. ("Fraunhofer") as part of its legal settlement with them (the "Fraunhofer Settlement Funds") in determining whether the Company is in compliance with the Liquidity Covenant (as defined in the Credit Agreement, which currently is a requirement that the Company maintain $7,500,000 in unrestricted cash) until a specified period dependent upon the occurrence of a specific milestone in the Credit Agreement.

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On February 20, 2023, iBio CDMO LLC entered into the Third Amendment to the Credit Agreement, which removed the added milestone specified in the Second Amendment, the failure of which would be an event of default. In addition, the Guaranty was amended to allow the Company until February 28, 2023, to account for the Fraunhofer Settlement Funds in determining whether the Company is in compliance with the Liquidity Covenant without being dependent upon a specified milestone. In addition, the Company agreed that each time it consummates an at-the-market issuance of Equity Interests (as defined within the Credit Agreement), no later than five (5) days following such issuance of Equity Interests, it will (a) pay to Woodforest in immediately available cash funds, without setoff or counterclaim of any kind, forty percent (40%) of the Net Proceeds (as defined within the Credit Agreement) received by the Company for such issuance of Equity Interests; provided, any such payment would cease upon payment obligations in full and (b) provide Woodforest with a detailed accounting of each such issuance of Equity Interests.

As a result of the payment of $2,1000,00 we received related to the Auction Sale Agreement we entered into on February 10, 2023, with Holland Industrial Group, together with Federal Equipment Company and Capital Recovery Group, LLC, we are currently in compliance with the Liquidity Covenant without including the Fraunhofer Settlement Funds in such calculation. However, based on current estimates, without additional funds, we do not anticipate being in compliance with the covenant on February 28, 2023 if we are unable to include the Fraunhofer Settlement Funds in such calculation. If the Company is unable to increase its unrestricted cash by February 28, 2023, and fails to meet the Liquidity Covenant, it would be in default of the terms of the Credit Agreement and the Guaranty and another amendment to the Credit Agreement and Guaranty may be necessary. The Company and Woodforest continue to be in discussions regarding a potential default and potential amendment to the Credit Agreement to rectify any such default.

The descriptions of the Third Amendment to the Credit Agreement and the Third Amendment to the Guaranty do not purport to be complete and are qualified in their entirety by reference to the Third Amendment to the Credit Agreement and the Third Amendment to the Guaranty, copies of which are filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.