Apmonia Therapeutics announces a new licensing agreement with SATT Nord to strengthen its portfolio of innovative peptides for oncology

On September 13, 2023 Apmonia Therapeutics, a biotechnology company developing new therapeutic strategies aimed at reprogramming the tumor microenvironment by targeting elements of the extracellular matrix, reported the signature of a new licensing agreement and the launch of a co-development program with SATT Nord (technology transfer office of universities in the "North of France) (Press release, SATT South-East, SEP 13, 2023, View Source [SID1234635095]). Apmonia Therapeutics has obtained exclusive worldwide rights on LBC peptides, now also referred as AP-04, a program currently in preclinical development with the potential to generate {first-in-class candidates for the treatment of various solid tumors, notably triple-negative breast cancer.

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AP-04 targets pro-cathepsin-D, a protein overexpressed in various cancers (breast, ovarian, lung, etc.), inhibiting its interaction with LRP-1 membrane receptor. Through this unique mechanism of action, ‘AP-04 blocks the effect of pro-cathepsin-D/LRP-1 interaction on fibroblast proliferation and its deleterious role in a tumoral context.

Initiated within a CNRS/University of Reims Champagne-Ardenne joint research unit (MEDyC), this program is the fruit of a co-development program lasting over a year between Apmonia Therapeutics {and SATT Nord, at the end of which a patent was filed. Apmonia Therapeutics and SATT Nord now plan ‘to consolidate and extend the preclinical proof-of-concept of AP-04 before its entry into regulatory development, a key step prior to the transition into clinical development.

"We are delighted with the development of Apmonia Therapeutics, since SATT Nord has already signed 4 first licensing agreement in 2019 with them, also with the relationship of trust, built over the long term, which is reflected in a co-development approach" says Fabrice Lefebvre, CEO of SATT Nord, adding, "We are delighted that a new asset resulting from academic research within the scope of SATT ‘Nord can now be valued and enter development with Apmonia Therapeutics, an industrial partner of choice for enhancing cutting-edge research on the extracellular matrix."

"This new asset strengthens and diversifies Apmonia Therapeutics’ intellectual property portfolio, It provides value in this portfolio," explains Claire Verschelde, partner at ICOSA and the company’s intellectual property consultant. "With a technology platform and several proprietary assets, including the most advanced on the eve of a first clinical trial, Apmonia Therapeutics has many assets in terms of intellectual property."

Entry into a Material Definitive Agreement

On September 12, 2023 Regen Biopharma, Inc. (the "Company") reported to have entered into a securities purchase agreement (the "Purchase Agreement") with Coventry Enterprises, LLC ("Coventry"), pursuant to which Coventry Enterprises purchased a 10% unsecured promissory Note (the "Note") from the Company in the principal amount of $175,000 of which $26,250 was retained by Coventry through an Original Issue Discount (Filing, 8-K, Regen BioPharma, SEP 12, 2023, View Source [SID1234635210]).

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The Note carries "Guaranteed Interest" on the principal amount at the rate of 10% per annum for the eighteen-month term of the Note for an aggregate Guaranteed Interest $26,250. The Principal Amount and the Guaranteed Interest shall be due and payable in seven equal monthly payments of $28,750 commencing on August 12, 2024 and continuing on the 12th day of each month thereafter until paid in full not later than March 12, 2025 (the "Maturity Date").

Upon an Event of Default (as such term is defined in the Note) the Note shall become convertible, in whole or in part, into shares of Common Stock at the option of the Holder at price per share equivalent to 90% of the lowest per-share trading price for the 20 Trading Days preceding a Conversion Date.

Upon the event that while this Note has been outstanding for four months, the Company consummates another financing transaction or if the Company has an effective Regulation A Offering Statement then the Investor may choose to convert any amount up to the entire balance of the note including guaranteed interest into shares at the same offering price as the aforementioned financing transaction or the Regulation A Offering..

The foregoing description of the abovementioned Purchase Agreement and Note are not complete and are qualified in their entirety by reference to the text of the abovementioned agreements , which are attached to this Current Report on Form 8-K as Exhibit 10.1 and 10.2 and incorporated in this Item 1.01 by reference.

On September 12, 2023 the Company entered into a common stock purchase agreement (the "Equity Line Agreement") with Coventry providing for an equity financing facility (the "Equity Line"). The Equity Line Agreement provides that upon the terms and subject to the conditions in the Equity Line Agreement, Coventry is committed to purchase up to Ten Million Dollars ($10,000,000) of shares of common stock, $0.0001 par value per share (the "Common Stock"), over the 36-month term of the Equity Line Agreement (the "Total Commitment").

Under the terms of the Equity Line Agreement, Coventry will not be obligated to purchase shares of Common Stock unless and until certain conditions are met, including but not limited to a Registration Statement on Form S-1 (the "Registration Statement") becoming effective which registers Coventry’s resale of any Common Stock purchased by Coventry under the Equity Line.

From time to time over the 36-month term of the Commitment Period ( as such term is defined in the Equity Line Agreement) the Company, in its sole discretion, may provide Coventry with a draw down notice (each, a "Draw Down Notice"), to purchase a specified number of shares of Common Stock (each, a "Draw Down Amount Requested"), subject to the limitations discussed below. The actual amount of proceeds the Company will receive pursuant to each Draw Down Notice (each, a "Draw Down Amount") is to be determined by multiplying the Draw Down Amount Requested by the applicable purchase price. The purchase price of each share of Common Stock equals 80% of the lowest trading price of the Common Stock during the ten business days prior to the Draw Down Notice date (the "Pricing Period").

The maximum number of shares of Common Stock requested to be purchased pursuant to any single Draw Down Notice cannot exceed the lesser of (i) 200% of the Average Daily Traded Value ( as such term is defined in the Equity Line Agreement) during the ten business days immediately preceding the Drawdown Notice Date or (ii) $250,000. The Company is prohibited from delivering a Draw Down Notice if the sale of shares of Common Stock pursuant to the Draw Down Notice would cause the Company to issue and sell to Coventry or Coventry to acquire or purchase an aggregate number of shares of Common Stock that would result in Coventry beneficially owning more than 4.99% of the issued and outstanding shares of Common Stock of the Company.

The Company is also required to issue Coventry 125,000 shares of its Common Stock. The Common Stock will be issued in reliance upon the exemptions from the registration requirements of the Securities Act of 1933, as amended, afforded the Company under Section 4(a)(2) promulgated thereunder.

Coventry has agreed that:

(a) for so long as the market price of the Company’s common stock is above $1.25 per share and

(b) the Company is in full compliance with all agreements entered into with Coventry and

(c) and the Company has not issued any common shares at a per share price below $1.50,

Coventry will agree to a leak out provision and will not sell more than 10,000 shares of the Commitment shares without permission from the Issuer.

In connection with the Equity Line Agreement the Company also entered into a Registration Rights Agreement, dated September 12, 2023 with Coventry (the "Registration Rights Agreement"), pursuant to which the Company agreed to register for resale under the Securities Act of 1933 shares issuable in accordance with the Equity Line Agreement as well as the aforementioned 125,000 common shares issued in connection with the Equity Line Agreement in a Registration Statement to be filed with the Securities and Exchange Commission.

It is intended that, in compliance with applicable SEC Compliance and Disclosure Interpretations, the total number of common shares to be registered in the initial Registration Statement shall total no more than one-third of the company’s public float at the time of execution of the Equity Line Agreement therefore the Company shall register 1,126,954 common shares. .

The foregoing description of the abovementioned Equity Line Agreement and Registration Rights Agreement are not complete and are qualified in their entirety by reference to the text of the abovementioned agreements , which are attached to this Current Report on Form 8-K as Exhibit 10.3 and 10.4 and incorporated in this Item 1.01 by reference.

Entry into a Material Definitive Agreement

On September 12, 2023, Rocket Pharmaceuticals, Inc. (the "Company") reported to have entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Leerink Partners LLC and Cowen and Company, LLC, as representatives of the several underwriters named in Schedule A thereto (collectively, the "Underwriters"), pursuant to which the Company agreed to issue and sell up to (i) 7,812,500 shares of common stock (the "Shares"), and (ii) pre-funded warrants (the "Pre-Funded Warrants") to purchase 3,126,955 shares of common stock (the "Offering") (Press release, Rocket Pharmaceuticals, SEP 12, 2023, View Source [SID1234635184]). In addition, the Company granted the Underwriters a 30-day option to purchase up to an additional 1,640,918 shares of its common stock (the "Option Shares").

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The Underwriters exercised their option to purchase the Option Shares in full, and the Offering closed on September 15, 2023.

The Shares and the Option Shares were sold in the Offering at the public offering price of $16.00 per share and were purchased by the Underwriters from the Company at a price of $15.04 per share. The Pre-Funded Warrants were sold at a public offering price of $15.99 per Pre-Funded Warrant, which represents the per share public offering price for the common stock less the $0.01 per share exercise price for each such Pre-Funded Warrant. Each Pre-Funded Warrant is exercisable as of September 15, 2023 until fully exercised, subject to an ownership limitation pursuant to the Underwriting Agreement.

The Offering was made pursuant to the Company’s effective registration statement on Form S-3 (Registration No. 333-253756), which was previously filed with the Securities and Exchange Commission under the Securities Act of 1933, as amended (the "Securities Act"), and declared effective on September 10, 2021.

The net proceeds from the Offering, after (i) giving effect to the Underwriters’ full exercise of their option to purchase the Option Shares and (ii) deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company, are expected to be approximately $188.9 million. The Company currently intends to use the net proceeds from the offering primarily to fund the further development of its pipeline of gene therapies for rare diseases, including the advancement of RP-A501 into a Phase 2 clinical trial and the continued clinical development of RP-A501, to accelerate the development of in-house manufacturing capabilities, and for general corporate purposes. The Company may also use a portion of the net proceeds to in-license, acquire or invest in complementary businesses or products. However, the Company currently has no agreements or commitments to complete any such transaction.

Pursuant to the Underwriting Agreement, the Company’s executive officers and directors, and certain other shareholders entered into agreements in substantially the form included as an exhibit to the Underwriting Agreement, providing for a 90-day "lock-up" period with respect to sales of the Company’s common stock, subject to certain exceptions.

The foregoing is a summary description of the Underwriting Agreement and is qualified in its entirety by the text of the Underwriting Agreement attached as Exhibit 1.1 to this Current Report on Form 8-K and incorporated herein by reference.

The form of Pre-Funded Warrant is filed as Exhibit 4.1 to this report and the description of the terms of the Pre-Funded Warrants is qualified in its entirety by reference to such exhibit.

A copy of the opinion of K&L Gates LLP relating to the validity of the Shares, the Option Shares and the Pre-Funded Warrants issued in the Offering is filed herewith as Exhibit 5.1.

Termination of Material Definitive Agreement

On September 12, 2023, Harpoon Therapeutics, Inc. (the "Company") received a Notice of Termination (the "Notice") from AbbVie Biotechnology Ltd ("AbbVie") terminating the Development and Option Agreement, dated November 20, 2019, by and between the Company and AbbVie (the "Agreement") (Filing, 8-K, Harpoon Therapeutics, SEP 12, 2023, View Source [SID1234635137]). AbbVie stated in the Notice that it will not exercise the exclusive license option under the Agreement, which granted AbbVie an option to a worldwide, exclusive license to the Company’s HPN217 program, which targets B cell maturation antigen. In accordance with the Agreement and the Notice and by mutual agreement of the Company and AbbVie, the termination of the Agreement will be effective on October 13, 2023. The aforementioned HPN217 program has been and will remain exclusively owned by the Company, and the Company plans to complete the ongoing Phase 1 clinical trial with data to support the next phase of development.

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Calidi Biotherapeutics to Present at Baird’s Global Healthcare Conference

On September 12, 2023 Calidi Biotherapeutics, Inc., (approved for listing on NYSE American under "CLDI"), a clinical-stage biotechnology company that is developing a new generation of targeted immunotherapies, reported that Allan Camaisa, CEO and Chairman of the Board, and Stephen Thesing, Chief Business Officer, will participate in a fireside chat at the upcoming Baird Global Healthcare Conference on Wednesday, September 13, 2023, at 7:55 a.m. ET (Press release, Calidi Biotherapeutics, SEP 12, 2023, View Source [SID1234635130]).

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