ORYZON strengthens patent portfolio for iadademstat and vafidemstat with new Decisions to Grant

On September 16, 2025 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, reported that it continues to expand its patent portfolio for iadademstat and vafidemstat, Oryzon’s clinical-stage LSD1 inhibitors for oncology and central nervous system (CNS) disorders, following new Decisions to Grant from the Australian and European patent offices (Press release, Oryzon, SEP 16, 2025, View Source;utm_medium=email&utm_campaign=NdP.27+2025-09-16+IP+additional+decision+grant+ENG778 [SID1234655986]).

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The Australian Patent Office has issued a Decision to Grant for Oryzon’s patent application AU2020249493, titled "Combinations of iadademstat for cancer therapy". The allowed claims cover combinations of iadademstat with PD1 or PD-L1 inhibitors for the treatment of cancer, including small cell lung cancer (SCLC). A Decision to Grant is an official communication from a national patent office indicating that a patent application has met all requirements for issuance as a patent. Once formally granted, this Australian patent will remain in force until at least 2040, not including any potential patent term extensions. A corresponding patent has also been granted in Russia, and applications are pending in Europe, the United States, Japan, China, and other countries.

Iadademstat is currently being evaluated in combination with PD-L1 inhibitors (atezolizumab or durvalumab) in first line SCLC patients with extensive disease in a Phase I/II trial conducted and sponsored by the U.S. National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) with Oryzon. More than 30 sites accross the U.S. participate in the trial, including leading institutions such as Memorial Sloan Kettering Cancer Center, Johns Hopkins, City of Hope, Yale University and the University of Chicago, among others.

Oryzon has also received a Decision to Grant from the European Patent Office for its patent application EP24205125.8, titled "Vafidemstat for treating behavior alterations". The allowed claims cover the use of vafidemstat for the treatment of aggressiveness and social withdrawal associated with CNS diseases. Among the allowed claims, there are claims specifically aimed at the treatment of aggressiveness associated with Borderline Personality Disorder (BPD), Autism Spectrum Disorder (ASD), Alzheimer’s disease and other conditions, as well as claims directed to treating social withdrawal associated with diseases such as schizophrenia or ASD. Once formally granted, this European patent will remain in force until at least 2038, not including any potential patent term extensions. Additional patents in this family have already been granted or allowed in Europe, Australia, Canada, Hong Kong, Israel, South Korea, Malaysia, the Philippines, and Russia, with applications pending in other countries.

Vafidemstat is in advanced clinical development for the treatment of aggression in psychiatric disorders, with an upcoming Phase III trial in aggression in BPD (protocol submitted), and a Phase II trial in aggression in ASD patients under preparation. In addition, a Phase II trial is ongoing in schizophrenia, with a focus on negative symptoms. One of the most prominent negative symptoms of schizophrenia is social withdrawal.

"These new patent grants strengthen Oryzon’s global IP position by protecting key therapeutic indications under clinical development for iadademstat and vafidemstat, thereby extending the commercial life for both compounds", said Neus Virgili, Oryzon’s Chief IP Officer.

Corporate presentation

On September 15, 2025 Purple biotech presented its corporate presentation (Presentation, Purple Biotech, SEP 15, 2025, View Source [SID1234656002]).

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Defence Therapeutics Completes Fully Subscribed Debenture Units Financing Of $2,000,000

On September 15, 2025 Defence Therapeutics Inc. ("Defence" or the "Company"), a leading biotechnology company specialized in drug delivery technologies, reported the closing of its previously announced non-brokered private placement of debenture units (the "Units") at a price of $1,000 per Unit for aggregate gross proceeds of $2,000,000 (the "Offering") (Press release, Defence Therapeutics, SEP 15, 2025, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-completes-fully-subscribed-debenture-units-financing-of-2000000 [SID1234655997]). Each Unit consisted of (i) one $1,000 principal amount 8.0% convertible debenture (a "Debenture"), and (ii) 1,666 common share purchase warrants (the "Warrants"). Further to the previous announcement on August 22, 2025, the Company has obtained the approval from the Canadian Securities Exchange to upsize the Offering from the aggregate proceeds of $1,200,000 to $2,000,000.

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The Debentures bear interest at a rate of 8.0% per annum and mature on September 15, 2027, subject to early redemption by the Company. The Debentures are unsecured and rank pari passu in right of payment of principal and interest with all the existing and future unsecured indebtedness of the Company. The principal amount of each Debenture is convertible at the option of the holder into common shares in the capital of the Company (each, a "Share") at the conversion price of $0.60 per Share (the "Conversion Price"). The accrued interest of the Debentures will be paid annually in Shares at the Conversion Price or in cash at the Company’s election.

Each Warrant is exercisable to acquire one Share (a "Warrant Share") at an exercise price of $0.75 per Warrant Share on or before September 15, 2027.

In connection with the Offering, the Company paid aggregate cash finder’s fees totalling $160,000 and issued 266,667 finder’s warrants (the "Finder’s Warrants") to qualified arm’s length finders. Each Finder’s Warrant is exercisable into one Share (a "Finder’s Warrant Share") at an exercise price of $0.75 per Finder’s Warrant Share on or before September 15, 2027.

The Company intends to use the net proceeds of the Offering to advance its science programs and for general working capital. All securities issued in connection with the Offering are subject to a statutory hold period of four months plus a day from their date of issue in accordance with applicable securities legislation.

The securities being referred to in this news release have not been, nor will they be, registered under the United States (U.S.) Securities Act of 1933, as amended, and may not be offered or sold in the U.S. or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from the registration requirements. This news release does not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

Entry Into a Material Definitive Agreement

On September 15, 2025, BullFrog AI Holdings, Inc. (the "Company") reported to have entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement"), with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which Lincoln Park committed to purchase up to $10.0 million of the Company’s common stock, par value $0.00001 per share (the "Common Stock"), subject to certain limitations and satisfaction of the conditions set forth in the Purchase Agreement (Filing, 8-K, Bullfrog AI, SEP 15, 2025, View Source [SID1234655993]).

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Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $10.0 million of the Company’s Common Stock (the "Purchase Shares"). Such sales of Common Stock by the Company, if any, will be subject to certain limitations set forth in the Purchase Agreement, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on the date that the conditions to Lincoln Park’s purchase obligation set forth in the Purchase Agreement are satisfied, including that a registration statement covering the resale by Lincoln Park of shares of Common Stock that have been and may be issued to Lincoln Park under the Purchase Agreement, which the Company agreed to file with the U.S. Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC (the date on which all of such conditions are satisfied, the "Commencement Date").

From and after the Commencement Date, provided the last closing sale price of Common Stock is not below $0.50 at or immediately prior to the time of sale, the Company may, by written notice, direct Lincoln Park to purchase up to 30,000 shares of our Common Stock, which amount may be increased depending on the last closing sale price of Common Stock at or immediately prior to the time of sale, subject to a maximum commitment of $500,000 on such business day (or the purchase date) at a purchase price per share that will be determined in accordance with the Purchase Agreement at the time the Company delivers such written notice to Lincoln Park (a "Regular Purchase"). The purchase price per share for each Regular Purchase will be based on prevailing market prices of the Common Stock at or prior to the time of sale as computed in accordance with the terms set forth in the Purchase Agreement. There are no upper limits on the price per share that Lincoln Park must pay for shares of Common Stock under the Purchase Agreement.

If the Company directs Lincoln Park to purchase the maximum number of shares of Common Stock that the Company may sell in a Regular Purchase, then in addition to such Regular Purchase, and subject to certain conditions and limitations in the Purchase Agreement, the Company may direct Lincoln Park to purchase additional shares of Common Stock in an "accelerated purchase" (each, an "Accelerated Purchase") and an "additional accelerated purchase" (each, an "Additional Accelerated Purchase") (including multiple Additional Accelerated Purchases on the same trading day) as provided in the Purchase Agreement. The purchase price per share for each Accelerated Purchase and Additional Accelerated Purchase will be based on market prices of the Common Stock on the applicable purchase date for such Accelerated Purchases and such Additional Accelerated Purchases.

The Company will control the timing and amount of any sales of Common Stock to Lincoln Park pursuant to the Purchase Agreement. Lincoln Park has no right to require the Company to sell any shares of Common Stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to certain conditions set forth in the Purchase Agreement.

Actual sales of shares of Common Stock to Lincoln Park will depend on a variety of factors to be determined by the Company from time to time, including, among others, general market conditions, the trading price of the Company’s Common Stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to Lincoln Park. The Company expects that any proceeds received by the Company from such sales to Lincoln Park will be used for working capital, capital expenditures and general corporate purposes.

In the case of Regular Purchases, Accelerated Purchases and Additional Accelerated Purchases, the purchase price per share will be equitably adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction occurring during the business days used to compute the purchase price.

The aggregate number of shares that the Company can sell to Lincoln Park under the Purchase Agreement may in no case exceed 2,048,936 shares (subject to adjustment as described above) of the Common Stock (which is equal to 19.99% of the shares of the Common Stock outstanding immediately prior to the execution of the Purchase Agreement) (the "Exchange Cap"), unless (i) stockholder approval is obtained to issue Purchase Shares above the Exchange Cap, or (ii) at the time the Company has issued shares of Common Stock equal to the Exchange Cap and at all times thereafter, the average price per share of Common Stock for all shares of Common Stock sold by the Company to Lincoln Park under the Purchase Agreement equals or exceeds $1.4053 per share (which represents the lower of (A) the official closing price of our Common Stock on Nasdaq on the trading day immediately preceding the date of the Purchase Agreement and (B) the average official closing price of our Common Stock on Nasdaq for the five consecutive trading days ending on the trading day immediately preceding the date of the Purchase Agreement, in each case as adjusted under applicable Nasdaq rules to take into account the issuance of shares of Common Stock to Lincoln Park for non-cash consideration as payment of the commitment fee described below so that the Exchange Cap limitation would not apply to issuances and sales of Common Stock under the Purchase Agreement pursuant to the rules and regulations of Nasdaq).

In all cases, the Purchase Agreement also prohibits the Company from directing Lincoln Park to purchase any shares of Common Stock if those shares, when aggregated with all other shares of Common Stock then beneficially owned by Lincoln Park (as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder), would result in Lincoln Park beneficially owning more than 4.99% of the then total outstanding shares of Common Stock.

There are no restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement or Registration Rights Agreement, except the Company is prohibited (with certain specified exceptions set forth in the Purchase Agreement) from effecting or entering into an agreement to effect an "equity line of credit" or other substantially similar offering whereby an investor is irrevocably bound to purchase securities over a period of time from the Company at a price based on the market price of the Common Stock at the time of each such purchase. Lincoln Park has agreed not to engage in or effect, directly or indirectly, for its own principal account or for the principal account of any of its affiliates, any short sales of the Common Stock or hedging transaction that establishes a net short position in the Common Stock during the term of the Purchase Agreement.

Pursuant to the terms of the Purchase Agreement, the Company will issue 147,682 shares of Common Stock (the "Commitment Shares") to Lincoln Park as consideration for its commitment to purchase shares of Common Stock under the Purchase Agreement.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and indemnification obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time with one business day notice, at no cost or penalty. Following the Commencement Date, if any "Suspension Event", as defined in the Purchase Agreement, occurs, Lincoln Park does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any regular or other purchase of shares by Lincoln Park, until such Suspension Event is cured.

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are summaries and are qualified in their entirety by reference to the full texts of the Purchase Agreement and Registration Rights Agreement, which are filed as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K and incorporated herein by reference. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting parties.

This current report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any shares of common stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Biocytogen Announces ADC Innovator Tubulis Has Signed Global Exclusive License Agreement for Single Antibody

On September 15, 2025 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, reported that ADC therapeutics developer, Tubulis has exercised an exclusive license for the global development and commercialization of a fully human antibody developed by Biocytogen (Press release, Biocytogen, SEP 15, 2025, View Source [SID1234655985]). The antibody will be applied in a novel ADC candidate proprietary to Tubulis. It is part of a previously signed research collaboration and option agreement to discover and advance antibody components for the development and commercialization of ADC products based on Biocytogen’s antibody discovery engine.

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The antibody was generated using Biocytogen’s proprietary RenMice platform and features high affinity, low immunogenicity, and favorable developability. Tubulis will apply its proprietary linker and payload technologies to develop innovative ADC therapies based on this antibody, aiming to address areas of high unmet clinical need in cancer treatment.

Dr. Yuelei Shen, President and CEO of Biocytogen, said, "We are very pleased that Tubulis has exercised its option, which reflects the international competitiveness and translational potential of our fully human antibody discovery platform. We look forward to seeing this antibody advance through Tubulis’ powerful ADC development engine and into clinical development to benefit patients around the world."

Jonas Helma-Smets, PhD, CSO and co-founder of Tubulis, stated: "Our goal is to drive innovation in ADC development and deliver uniquely positioned ADC therapeutics that can improve treatment outcomes to patients with solid tumors. The R&D collaboration with Biocytogen has yielded an antibody candidate that we believe fits well with our ADC technology platforms and that may support us in the development of a novel therapeutic candidate."

Under the terms of the agreement, Biocytogen will receive an upfront payment and is eligible for certain development, regulatory, and commercial milestone payments, and single-digit royalties on net sales.