Generex Biotechnology Corp., of Miramar, Fla., said it acquired an additional 38% of Olaregen Therapeutix Inc., of New York, for total ownership of approximately 99% through a cashless exchange of Generex stock (OTCQB:GNBT) at $2.50 per share. Olaregen is a regenerative medicine company focused on the development, manufacturing and commercialization of products that fill unmet needs in the wound care market, including Excellagen (flowable dermal matrix), a topically applied product for dermal wounds and other indications that also may serve as an enabling delivery platform for pluripotent stem cells, antimicrobial agents, small-molecule drugs, DNA-based biologics, conditioned cell media and peptides. Generex also said it made the final payment of $138,000 to a noteholder that, together with a payment of $900,000 on Aug. 16, cleared more than $1 million in debt from its books as its application to up-list to Nasdaq is processed. Additionally, Generex said it is preparing the merger documents for Nugenerex Immuno-Oncology, the publicly traded spinout that will house assets from the acquisition of Kiromic Inc. and from Generex subsidiary Antigen Express Inc., which is developing the Erbb2 tyrosine kinase receptor modulator AE-37 in combination with checkpoint inhibitors to treat triple-negative breast cancer. Generex said it plans to disclose additional details in an 8-K filing with the SEC. On Monday, Generex shares gained 15 cents to close at $2.20.

Jaguar Health Inc., of San Francisco, said positive top-line results were achieved in a preclinical pharmacological study of crofelemer in diarrhea induced in healthy dogs by maximally tolerated doses of a specific tyrosine kinase inhibitor (TKI), showing that combined crofelemer groups demonstrated superior benefit for responders (p=0.01). Data are expected to provide additional scientific rationale and support use of the drug in providing symptomatic relief of noninfectious diarrhea in humans receiving TKI and/or other targeted cancer therapy-containing regimens in future trials.

Mateon Therapeutics Inc., of Agoura Hills, Calif., said it reached agreement to merge with privately held Pointr Data Inc., of Santa Clara, Calif., to create a publicly traded artificial intelligence (AI)-driven immuno-oncology company with a pipeline of TGF-beta immunotherapies targeting late-stage cancers such as gliomas, pancreatic cancer and melanoma. The agreement calls for Pointr to merge into and become a wholly owned subsidiary of Mateon in exchange for holders of Pointr common stock to receive $15 million in Mateon common shares (OTCQB:MATN), calculated at 18 cents per share. Pointr shareholders also will be entitled to two additional tranches of $7.5 million apiece in Mateon common shares, based on the separate achievement of proof-of-concept data and of a licensing deal for AI-based assets with a minimum of $100 million in lifetime licensing fees, of which at least $10 million are received by the company. Value of the additional Mateon shares will be based on the market price at the time of payment, subject to a minimum of 18 cents per share. The merger's close is conditioned on Mateon raising at least $10 million in an equity financing or $5 million in a commercial agreement and on the company's agreement to grant a license allowing Pointr's former shareholders to use elements of the AI technology in fields outside pharmaceutical development. Earlier this year, Mateon completed a merger with Oncotelic Inc., gaining lead compound OT-101 (trabedersen), a phosphorothioate TGF beta 2-specific antisense oligodeoxynucleotide. On Monday, Mateon's shares gained 3.5 cents to close at 25.5 cents. (See BioWorld, April 26, 2019.)

Motif Bio plc, of London, said it will use the suite of preclinical services at the National Institute of Allergy and Infectious Diseases (NIAID), an agency of the NIH, through JMI Laboratories, to evaluate iclaprim against Listeria monocytogenes, a gram-positive bacteria causing food-borne, life-threatening infections. The study, which will be funded by NIAID, follows earlier in vitro testing in which iclaprim was shown to be ≥32-fold more potent than standard-of-care ampicillin and demonstrated consistent extracellular and intracellular activity against L. monocytogenes. In February, the FDA issued a complete response letter requesting additional liver toxicity data in the company's NDA for iclaprim to treat acute bacterial skin and skin structure infections caused by gram-positive pathogens. (See BioWorld, Feb. 15, 2019.)

Oncology Pharma Inc., of San Francisco, said it signed a letter of intent with Kalos Therapeutics Inc., of Phoenix, covering global licensing and co-development of Kalos' lead candidate, KTH-222, a MAP kinase inhibitor, as a monotherapy and/or in combination with Nanosmart Pharmaceuticals Inc.'s targeted antinuclear antibody-conjugated liposomal doxorubicin delivery system, for which Oncology Pharma holds an exclusive global license. Financial terms were not disclosed.

Siamab Therapeutics Inc., of Newton, Mass., said it entered an agreement valued at up to $202 million with an undisclosed, large commercial-stage biopharmaceutical company under which the latter will develop and commercialize antibody-based products targeting a tumor-associated carbohydrate antigen (TACA) identified by Siamab's TACA discovery platform. Under the terms, Siamab will receive a multimillion-dollar initial payment and is eligible to receive additional payments when specific milestones are achieved. No additional terms are being disclosed.

Spherix Inc., of New York, issued a letter encouraging its shareholders to vote in favor of the acquisition of CBM Biopharma Inc., also of New York, during a special meeting set for Sept. 5. Spherix said its board intends to propose at the meeting a special dividend of 100,000 shares of stock, valued at approximately $500,000, from its stake in Hoth Therapeutics Inc., of New York, acquired in 2017, contingent on obtaining the necessary votes for the CBM acquisition.

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