On December 20, 2021 Avecho Biotechnology Limited (ASX:AVE) has reported it has entered into a licensing and supply agreement with Medterra Pharma – one of the most successful CBD companies in the United States – to develop and commercialise Avecho’s soft-gel CBD capsule for the treatment of arthritis (Press release, Phosphagenics, DEC 20, 2021, View Source [SID1234597431]).

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Arthritis represents a promising opportunity for development, with the osteoarthritis therapeutics market projected to reach US$11 billion by 2025. Medterra scientists have already demonstrated the therapeutic potential of CBD for arthritis in preclinical models, and a six-week human study using the soft-gel for pain reduction in patients with osteoarthritis of the knee is scheduled for early next year.

This partnership is a strategic move for our Company. We know that our product has wide-ranging potential for a number of indications, and our ambition is to secure FDA approval for our proprietary CBD soft-gel product. By working in partnership with a reputable, well-resourced partner, this allows us to pursue regulatory approval in the US in parallel to our current efforts to register our product for sleep indications with the TGA in Australia.

On December 20, 2021 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematological cancers, reported the completion of a US$25 million long-term debt facility led by Horizon Technology Finance Corporation (Nasdaq: HRZN) ("Horizon") (Press release, IMV, DEC 20, 2021, View Source [SID1234597450]). IMV has drawn down US$15 million with an additional US$10 million to be made available upon achievement of a pre-set milestone.

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"This partnership with Horizon complements our recent US$25 million equity offering and strengthens our runway and flexibility as we continue to advance MVP-S and DPX-SurMAGE through their next set of clinical and regulatory milestones. We will also be able to continue exploring the versatility of our DPX technology platform," said Pierre Labbe, Chief Financial Officer of IMV. "Throughout this investment process, the Horizon team demonstrated understanding of both our business and the science."

"We are excited to support IMV’s efforts at such a pivotal time for the Company," said Gerald A. Michaud, President of Horizon. "This financing is in line with our strategy of investing in innovative life sciences and healthcare companies whose success will help to improve outcomes for patients and enhance public health more broadly."

US$15 million of the US$25 million facility was funded upon closing, of which CAD$4.5 million will be used to pay off IMV’s existing term loan with the government of Nova Scotia. The additional US$10 million available under the facility will be accessible upon IMV achieving a predetermined milestone. Proceeds from the facility will be used to support the ongoing clinical development of key investigational product candidates within IMV’s pipeline and for general working capital purposes.

In connection with this debt financing, IMV has agreed to issue Horizon warrants (the "Loan Warrants") to purchase up to 568,180 common shares of the Company (the "Shares") at an exercise price of US$1.32

per Share until December 17, 2031. 454,544 Loan Warrants have been issued on December 17, 2021, and the balance of 113,636 Loan Warrants is expected to be issued upon drawdown of the additional US$10 million available under the facility will be accessible upon IMV achieving a predetermined milestone. The Loan Warrants and the Shares issuable upon exercise thereof will be subject to a statutory hold period of four months following the issuance of the Loan Warrants in accordance with applicable securities laws. For the purpose of Toronto Stock Exchange ("TSX") approval, the Company is relying on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as NASDAQ, provided that the transaction is being completed in compliance with the requirements of such other recognized exchange.

The securities offered have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as such term is defined in Regulation S under the U.S. Securities Act) absent registration under the U.S. Securities Act and all applicable state securities laws, or compliance with an exemption from such registration requirements. This press release shall 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.

On December 20, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported the closing of its previously announced underwritten public offering of 3,802,144 shares of its common stock, which includes the exercise in full of the underwriters’ option to purchase 645,000 additional shares, and to certain investors, pre-funded warrants to purchase 1,142,856 shares of its common stock at an exercise price of $0.0001 (Press release, Syndax, DEC 20, 2021, View Source [SID1234597475]). The public offering price of each share of common stock was $17.50 and the public offering price of each pre-funded warrant was $17.4999 per underlying share, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant. The gross proceeds to Syndax from this offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $86.5 million.

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Goldman Sachs & Co. LLC and Cowen acted as joint book-running managers for the offering. BTIG acted as lead manager for the offering. B. Riley Securities acted as co-manager for the offering.

The shares were offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the website of the SEC at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs and Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at [email protected], or by phone at (833) 297-2926.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus, which are a part of the effective registration statement.

On December 20, 2021 Pfizer reported is to enter the medical cannabis industry betting on a promising cannabinoid-based bowel disease treatment (Press release, Biosortia Pharmaceuticals, DEC 20, 2021, View Source [SID1234607738]).

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Last week, American multinational pharmaceutical and biotechnology corporation Pfizer signed an agreement with the clinical-stage company Arena Pharmaceuticals for a total equity value of around $6.7 billion.

Under the agreement terms, Pfizer acquires all shares for $100 per share in an all-cash transaction. Moreover, the press release reads that the proposed transaction will be subject to customary closing conditions, including receipt of regulatory approvals and approval by Arena’s stockholders.

Arena Pharmaceuticals is a biotech company with one pipeline dedicated to cannabinoid-type therapeutics. The core of its cannabis operation consists of Olorinab (APD371), an investigational, oral, full agonist of the cannabinoid type 2 receptor (CB2), which aims to treat patients with diseases affecting the stomach and intestine. As Arena’s website states, Olorinab is an investigational drug and is not currently approved for use by any health authority.

Arena’s team is developing this cannabinoid-based drug with an initial focus on visceral pain associated with gastrointestinal disorders. Arena’s website reads that this compound, through its selectivity for CB2 versus CB1, is under investigation for pain relief without psychoactive adverse effects.

CB1 and CB2 receptors bind to the endocannabinoid system, a complex cell-signaling system. These receptors are present throughout the human body. Endocannabinoids, such as THC and CBD, can bind to both receptors to signal that the endocannabinoid system needs to take action. However, the effects depend on the endocannabinoid receptor and the cannabinoid’s interaction with the receptor.

"The proposed acquisition of Arena complements our capabilities and expertise in Inflammation and Immunology, a Pfizer innovation engine developing potential therapies for patients with debilitating immuno-inflammatory diseases with a need for more effective treatment options," said in the press release Mike Gladstone, Global President of Inflammation & Immunology at Pfizer.

Amit D. Munshi, President and Chief Executive Officer (CEO) of Arena, said that Pfizer’s capabilities would accelerate Arena’s mission to deliver essential medicines to patients and believes this transaction represents the best next step for both patients and shareholders.

"We’re delighted to announce Pfizer’s proposed acquisition of Arena, recognizing Arena’s potentially best in class S1P molecule and our contribution to addressing unmet needs in immune-mediated inflammatory diseases," he said.

Arena’s portfolio also includes other non-cannabinoid drug pipelines, focusing on developing innovative potential therapies to treat several immuno-inflammatory diseases.

By acquiring Arena, Pfizer enters the medical cannabis industry and joins other Big Pharma companies in the cannabis space.

Big pharmaceutical companies have entered the market through several operations in the past years.

Canadian research and development (R&D) company Avicanna became a resident company at Jonhson & Johnson’s JLabs in Toronto in 2017.

One year later, Canadian Tilray went global through an agreement with Swiss pharmaceutical company Novartis AG to develop and distribute its medical cannabis products in legal jurisdictions worldwide.

In May 2021, global biopharmaceutical company Jazz Pharmaceutical completed the acquisition of GW Pharmaceuticals, the developer of Epidiolex, the first FDA-authorized CBD medicine for treating children with Lennox-Gastaut and Dravet syndromes.

Like Big Tobacco companies, Big Pharma’s interest in the medical cannabis industry grows with the space’s fast-evolving cannabinoids industry. R&D on cannabinoids is achieving exciting results in the treatment application. For this reason, it is expected to see further involvement of pharmaceutical companies in the medical cannabis industry in the following years.

On December 20, 2021 Aptose Biosciences Inc. ("Aptose") (NASDAQ: APTO, TSX: APS) reported its decision to discontinue further clinical development of APTO-253 (Press release, Aptose Biosciences, DEC 20, 2021, View Source [SID1234597451]). The decision follows prioritization of the company’s other more advanced pipeline candidates, as well as an internal review of the product profile and performance to date of APTO-253, including a clinical hold placed by the U.S. Food & Drug Administration.

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"We plan to enter the new year 2022 focused exclusively on the swift development of our kinome inhibitors HM43239 and luxeptinib, both of which recently have demonstrated encouraging clinical activity in challenging hematologic malignancies," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "APTO-253 remains an interesting product that has demonstrated MYC repression, which creates optionality across the wider oncology spectrum. Moving forward, we plan to explore available strategic alternatives for this compound."