On March 23, 2022 / BullFrog AI Holdings, Inc., a biopharmaceutical company focused on applying its proprietary Artificial Intelligence/Machine Learning platform to improve drug development and shorten clinical trial timelines, reported that it has entered into an exclusive license agreement with Johns Hopkins University for use of its novel formulation of mebendazole in treating cancer (Press release, Bullfrog AI, MAR 23, 2022, View Source [SID1234635364]).

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Under the terms of the agreement, BullFrog AI was granted an exclusive worldwide license to manufacture and use a novel formulation of mebendazole developed at the Johns Hopkins University (JHU) School of Medicine for treatment of cancer. This formulation is enriched in a polymorph of the drug which shows improved bioavailability, is particularly effective in crossing the blood-brain barrier, and has shown potent antitumor activity in multiple animal models of different cancers. In addition, it has been evaluated in a Phase I clinical trial in patients with high-grade gliomas (NCT01729260). The trial, an open-label dose-escalation study, enrolled 24 patients and demonstrated long-term safety and acceptable toxicity of mebendazole with adjuvant temozolomide in this population.

"We are excited to enter into this agreement with Johns Hopkins University for exclusive use of this unique formulation of mebendazole to treat cancer," said Vin Singh, Founder and CEO of BullFrog AI. "We look forward to pursuing development of this drug with Dr. Greg Riggins, Professor of Neurosurgery and Oncology at Johns Hopkins University and scientific advisor to BullFrog AI, for treatment of several devastating cancers. This drug enters our expanding pipeline as BF-222, and we will be engaging with the FDA in conversations about our clinical development plan in the near future. We are confident that bfLEAP, our proprietary AI/Machine Learning platform, provides us with an essential tool that we can leverage to efficiently develop this and other drugs that are being added to our pipeline to address unmet medical needs."

"Our Phase I clinical trial in patients with newly diagnosed high-grade gliomas showed that this novel formulation of Mebendazole is safe to use in combination with adjuvant temozolomide and provided valuable information regarding dosing," said Greg Riggins, MD, PhD. "I look forward to working with the team at BullFrog AI to pursue development of BF-222 for treating cancer."

On March 23, 2022 Cyclica Inc. ("Cyclica"), a neo-biotech with the vision to advance the most robust and sustainable drug discovery pipeline, and Arctoris Ltd. ("Arctoris"), a tech-enabled biopharma company that combines its unique automation with computational approaches to progress drug discovery, reported that they have agreed to expand their partnership to progress drug discovery programs for novel neurodegenerative targets with a focus on Alzheimer’s disease (Press release, Arctoris, MAR 23, 2022, View Source;utm_medium=rss&utm_campaign=cyclica-and-arctoris-to-expand-partnership-to-advance-drug-discovery-programs-for-alzheimers-disease [SID1234612706]). This planned expansion of the partnership follows the results from an initial engagement that yielded positive results for targets related to both oncology and neurodegenerative disease.

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"Cyclica’s platform and capabilities in combination with the biological assay development of Arctoris will enable us to yield meaningful results and advance research development for patients suffering from Alzheimers and other neurodegenerative diseases. The potential of combining our two specialities is very promising and we are extremely optimistic about the impact this partnership is expected to have on patients" shares Naheed Kurji, Co-Founder, President and CEO of Cyclica.

Dr. Martin-Immanuel Bittner, MD DPhil FRSA, CEO of Arctoris, comments by sharing, "Our joint drug discovery program focuses on dual specificity inhibitors – a very promising yet also challenging modality. Cyclica is one of the leaders in this space, leveraging their structure-based and AI-directed molecule design for polypharmacology, while at Arctoris we have built a particular expertise in complex mechanistic enzymology and advanced cell-based models in neurodegeneration. This is a highly synergistic partnership, and I am excited about what we can achieve together for patients around the world in an indication area in dire need of new and better treatment options."

Cyclica and Arctoris have long-term plans for their partnership as discussions are already underway about tackling additional therapeutic targets.

On March 23, 2022 Ube Industries, Ltd. (hereinafter referred to as "Ube Industries"; Headquarters: Yamaguchi Prefecture; President: Masato Izumihara) is pleased to announce that it has signed a license agreement with Kirilys Therapeutics, Inc. (hereinafter referred to as "Kirilys"; Headquarters: San Francisco, California, U.S.; Executive Chairman: BT Slingsby), a company founded by venture capital firm Catalys Pacific, to grant an exclusive worldwide license to Kirilys for the CDK7 inhibitor, KRLS-017, discovered by Ube Industries (Press release, Ube Industries, MAR 23, 2022, View Source [SID1234611012]).

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KRLS-017 is a reversible small molecule inhibitor of Cyclin Dependent Kinase 7 (CDK7). CDK7 has been implicated as a key regulator of both transcriptional addiction and cell cycle dysregulation in tumors and therefore represents an attractive target for therapeutic intervention across a broad range of solid tumors and hematologic malignancies.
In preclinical studies, KRLS-017 demonstrated best-in-class potency, selectivity, and anti-tumor efficacy along with very favorable properties for an oral drug and thus is expected to make a great contribution for the treatment of diseases with high unmet medical needs as an antitumor drug.

Under this license, Kirilys acquires the rights to the future development, manufacture, and marketing of KRLS-017.

Yoichi Funayama, Executive Officer and General Manager of the Pharmaceutical Business Division of Ube Industries, said, "We are working on drug discovery every day to provide more options for the treatment of diseases with high unmet medical needs. One of the fields with high unmet medical needs is that of antitumor drugs, and we have high hopes that KRLS-017 can contribute as one of the new treatment options in this area. We believe that the involvement of Kirilys, founded by members with a high level of expertise and abundant experience in antitumor drug development, in the development of KRLS-017 will further raise the possibility to achieve our purpose."

BT Slingsby, Executive Chairman of Kirilys and Managing Partner of Catalys Pacific said, "We founded Kirilys to promote the development of therapeutics that combine innovative science in precision oncology with excellent drug discovery from Japan. KRLS-017 holds significant potential for worldwide patients with cancers who have limited treatment options. We look forward to developing KRLS-017 with the well experienced Kirilys team together.

On March 23, 2022 Histogen Inc. (NASDAQ: HSTO), a clinical-stage company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported that it has entered into a securities purchase agreement with certain institutional investors to purchase 2,500 shares of Series A redeemable convertible preferred stock and 2,500 shares of Series B redeemable convertible preferred stock (Press release, Conatus Pharmaceuticals, MAR 23, 2022, View Source [SID1234610984]). Each share of Series A and Series B preferred stock has a purchase price of $952.38, representing an original issue discount of approximately 5% of the $1,000 stated value of each share. Each share of Series A and Series B preferred stock is convertible into shares of Histogen’s common stock at an initial conversion price of $1.00 per share. Shares of the Series A and Series B preferred stock are convertible at the option of the holder at any time following the Company’s receipt of stockholder approval for an amendment to the Company’s certificate of incorporation that allows the Company to effectuate a reverse stock split of the Company’s common stock. Histogen will be permitted to compel conversion of the Series A and Series B preferred stock after the fulfillment of certain conditions and subject to certain limitations. Total net proceeds from the offerings, before deducting the placement agent’s fees and other estimated offering expenses, is approximately $4.75 million.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The Series A and Series B preferred stock permit the holders thereof to vote together with the holders of the Company’s common stock on a proposal to effect a reverse stock split of the Company’s common stock at an annual or special meeting of Company stockholders. The Series A preferred stock permits the holder to vote on such proposal on an as-converted to common stock basis based on the minimum price under Nasdaq rules on the issuance date. The Series B preferred stock permits the holder to cast 30,000 votes per share of Series B preferred stock on such proposal. The Series A and Series B preferred stock will not be permitted to vote on any other matter. The holders of the Series A and B preferred stock agreed not to transfer their shares of preferred stock until after the stockholder meeting. The holders of the Series A preferred stock agreed to vote their shares on the reverse stock split proposal and the holders of the Series B preferred stock agreed to vote their shares on such proposal in the same proportions as the shares of common stock and Series A preferred stock are voted on such proposal. The holders of the Series A and Series B preferred stock have the right to require the Company to redeem their shares of preferred stock for cash at 105% of the stated value of such shares commencing after the earlier of the Company’s stockholders’ approval of the reverse stock split and 90 days after the closing of the issuances of the Series A and Series B preferred stock and until 120 days after such closing.

The closing of the offering is expected to occur on or about March 25, 2022, subject to the satisfaction of customary closing conditions. Additional information regarding the securities described above and the terms of the offering are included in a Current Report on Form 8-K to be filed with the United States Securities and Exchange Commission ("SEC").

To the extent Series A or B preferred stock is converted or otherwise not redeemed after 120 days from closing, the Company will use such net proceeds from this offering for working capital and general corporate purposes.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Under an agreement with the investors, the Company agreed to file an initial registration statement with the Securities and Exchange Commission (the "SEC") covering the resale of the shares of common stock issuable upon conversion of the preferred stock no later than July 20, 2022, and to use commercially reasonable efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than September 18, 2022 (or October 18, 2022, in the event of a "full review" of the registration statement by the SEC).

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

On March 23, 2022 Arcadia Biosciences, Inc. (Nasdaq: RKDA), a producer and marketer of innovative, plant-based health and wellness products, reported that it will release its 2021 fourth-quarter and full-year financial and business results after market close on March 30, 2022 (Press release, Arcadia Biosciences, MAR 23, 2022, View Source [SID1234610939]).

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The company has scheduled a conference call for 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss fourth-quarter and year-end results and the year’s key strategic achievements. Interested participants can join the conference call using the following numbers:

A live webcast of the conference call will be available on the Investors section of Arcadia’s website at www.arcadiabio.com. Following completion of the call, a recorded replay will be available on the company’s investor website.