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DEFENCE’S SUCCESSFULL STUDY ON THE ACCUVAC-PT007 VACCINE TARGETING CERVICAL CANCER

On November 23, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immuneoncology vaccines and drug delivery technologies, reported the successful completion of its Good Laboratory Practice ("GLP") studies on the AccuVAC-PT007 vaccine candidate specifically designed to target cervical cancer (Press release, Defence Therapeutics, NOV 23, 2022, View Source [SID1234626256]). GLP studies conducted on rodents demonstrate a full spectrum of safety and tolerability with no signs of complications.

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Cervical cancer normally occurs when epithelial cells of the cervix are infected with the human papillomavirus (HPV), one of the most common sexually transmitted disease. Although HPV infections can resorb, infections escaping the immune system ultimately led to genital warts leading to advanced cancers that are hardly treated with standard of care. Currently, vaccination targeting HPV directly can protect from cervical cancer. However commercially available vaccines (containing a mix of 9 HPV-derived L1 proteins) are not designed to protect from all HPV subtypes and the vaccine on the market cannot be used to treat pre-established cervical cancer. Defence focused on this "gap" by engineering AccuVAC-PT007, a protein-based vaccine containing a single oncoprotein (E7) linked to AccumTM for enhanced antigen presentation by the immune system. This vaccine can not only be used to protect from HPV (prophylactic use), but it is the only experimental vaccine capable of curing established cervical cancer when combined to immune-checkpoint inhibitors. The AccuVac may be a solution.

Using the AccumTM platform, Defence developed the AccuVAC-PT007, a protein-based vaccine targeting the E7 oncoprotein of the HPV virus. AccuVAC-PT007 was previously shown to provide complete protection against cervical cancer (prophylactic vaccination) as shown in our press release dated on May 17, 2022. These ground-breaking observations led to the testing of AccuVAC-PT007 as a treatment with pre-established cervical cancer (therapeutic vaccination). Pre-clinical studies conducted on rodents, as reported in our press release dated on June 27, 2022, showed that the co-delivery of AccuVAC-PT007 with several immune-checkpoint blockers (antiPD-1, anti-CTLA4 or anti-CD47) lead to potent control of tumor growth with a more pronounced effect observed with anti-CD47, one of the latest immune-checkpoint blockers undergoing clinical development.

"The successful completion of the GLP studies clearly demonstrate the safety and tolerability profile of our AccuVAC-PT007 vaccine. With only one oncoprotein (E7) linked to our AccumTM, we would significantly reduce the manufacturing cost and more importantly our vaccine would have the capacity to cure established cervical cancer. It is another strong example of Defence’s AccumTM technology versatility. And it also shows how dedicated we are in developing efficiently vaccines to eradicate tumors. Our AccuVAC-PT007 vaccine is now ready for a Phase I Clinical Trial or partnership/licence with a Pharma", adds Mr. Plouffe, the CEO of Defence Therapeutics.

Besides cervical cancer, HPV can cause cancer of the vulva, vagina, penis, or anus. It can also cause cancer in the back of the throat (called oropharyngeal cancer) and can include the base of the tongue and tonsils. In addition, patients with weak immune systems may be unable to fight off a given HPV infection, which brings forward another important ailment with unmet medical needs. This is an opportunity for the AccuVAC-PT007 that Defence has developed.

Cervical cancer has a high mortality rate (nearly 50%), which can be reduced by diagnosis and prevention. A report from 360ResearchReports projected that the global Cervical Cancer Treatment market size is expected to expand at a CAGR of 4.8% during the forecast period, reaching USD 11 Billion by 2027.

Entry into a Material Definitive Agreement

On November 23, 2022, Eterna Therapeutics Inc., a Delaware corporation (the "Company"), reported that entered into a Securities Purchase Agreement (the "Purchase Agreement") with certain investors (the "Purchasers") providing for the private placement (the "Private Placement") to the Purchasers of an aggregate of 2,184,950 units (collectively, the "Units"), each Unit consisting of (i) one share of the Company’s common stock, par value $0.005 per share ("Common Stock") and (ii) two warrants, each exercisable to purchase one share of Common Stock at an exercise price of $3.28 per share (the "Warrants"), for an aggregate purchase price of approximately $7.7 million, consisting of $3.53 per Unit (inclusive of $0.125 per Warrant) (Filing, 8-K, Brooklyn ImmunoTherapeutics, NOV 23, 2022, View Source [SID1234624421]). Pursuant to the Purchase Agreement, the parties thereto have agreed that the offering of the Units will close on December 2, 2022, subject to satisfaction of customary closing conditions (the "Closing").

Upon issuance at Closing, each Warrant will become exercisable six months following the date of Closing, will expire five-and-one-half years following such date, and will be subject to customary adjustments. The Warrants purchased by certain of the Purchasers may contain a provision pursuant to which such Warrants may not be exercised if the aggregate number of shares of Common Stock beneficially owned by the holder thereof would exceed 4.99% immediately after exercise thereof, subject to increase to 9.99% at the option of the holder.

Mr. Charles Cherington, Chairman of the Company’s Board of Directors, and Mr. Nicholas Singer, a director of the Company, participated in the Private Placement on the same terms and subject to the same conditions as all other Purchasers.

The Company intends to use the net proceeds from the Private Placement for general working capital purposes.

The securities to be issued to the Purchasers under the Purchase Agreement were offered in reliance on an exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and Rule 506 of Regulation D promulgated thereunder. The Company relied on this exemption from registration based in part on representations made by the Purchasers, including that each Purchaser is an "accredited investor", as defined in Rule 501(a) promulgated under the Securities Act.

The offer and sale of the securities pursuant to the Purchase Agreement have not been registered under the Securities Act or any state securities laws. The securities may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Neither this Current Report on Form 8-K, nor the exhibits attached hereto, is an offer to sell or the solicitation of an offer to buy the securities described herein or therein.

Pursuant to the Purchase Agreement, the Company and the Purchasers have also agreed to enter into a Registration Rights Agreement at the Closing, pursuant to which the Company will agree to prepare and file a registration statement on Form S-3 with the Securities and Exchange Commission no later than 30 days following the date on which the Company becomes eligible to use Form S-3 to register the resale of the shares of Common Stock included in the Units and the shares of Common Stock issuable upon exercise of the Warrants.

The foregoing description of the Purchase Agreement is only a summary and is qualified in its entirety by reference to the full text of such agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference herein.

Molecular Templates, Inc. to Present Fireside Chats at Two Upcoming Investor Conferences: Evercore ISI’s 5th Annual HealthCONx Conference and Piper Sandler’s 34th Annual Healthcare Conference

On November 23, 2022 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported that CEO, Eric Poma, Ph.D., will present a virtual fireside chat at Evercore ISI’s 5th Annual HealthCONx conference which will take place November 29 – December 1, 2022, and an in-person fireside chat with an analyst Q&A portion at Piper Sandler’s 34th Annual Healthcare Conference in New York, NY which will take place November 29 – December 1, 2022 (Press release, Molecular Templates, NOV 23, 2022, View Source [SID1234624416]). Highlighting positive incremental data, the chats will comprise a review of the de-immunized next-generation ETB scaffold and programs. One-on-one meetings may be scheduled with banking representatives of Evercore ISI or Piper Sandler, respectively, or directly with Molecular Templates.

Evercore ISI 5th Annual HealthCONx Conference

Piper Sandler 34th Annual Healthcare Conference

Kiniksa Pharmaceuticals to Present at Evercore ISI 5th Annual HealthCONx Conference

On November 23, 2022 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) reported that management will participate in a fireside chat at the Evercore ISI 5th Annual HealthCONx Conference on Wednesday, November 30, 2022 at 10:05 a.m. Eastern Time (Press release, Kiniksa Pharmaceuticals, NOV 23, 2022, View Source [SID1234624415]).

A live webcast of Kiniksa’s presentation will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.

Vivoryon Therapeutics AnnouncesSuccessful Listing of 2,054,796 Shares

On November 23, 2022 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) ("Vivoryon" and hereinafter the "Company"), a clinical stage company focused on the discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, reported that it has successfully completed the listing of 2,054,796 shares issued pursuant to its private placement announced on September 30, 2022 (Press release, Vivoryon Therapeutics, NOV 23, 2022, View Source [SID1234624412]). The private placement was supported by Vivoryon’s longstanding investor Claus Christiansen as well as a platform controlled by affiliates of Kohlberg Kravis Roberts & Co. L.P. ("KKR"), a leading global investment firm, as new investor to the Company (the "Investors").

Vivoryon is pioneering a unique therapeutic approach to overcoming the challenges in Alzheimer’s disease ("AD") drug development. The Company has demonstrated evidence of the disease modifying capabilities of its lead candidate varoglutamstat, currently in Phase 2 clinical studies in Europe and the U.S.. Underscoring the unique potential of varoglutamstat in mono- and combination therapy settings in AD, data generated to date show the potential for cognitive improvement and a beneficial safety profile at doses of high target engagement.

As previously announced, the Investors agreed to invest an amount of EUR 15.0 million in the Company by purchasing 2,054,796 new ordinary shares at an offering price of EUR 7.30 per share by means of a capital increase from the Company. The new shares issued at the time of the offering represented 9.3% of Vivoryon’s issued share capital immediately prior to completion of the offering and were issued from the Company’s authorized capital under exclusion of the existing shareholders’ pre-emptive rights. As a consequence, the Company’s issued share capital increased to EUR 24,105,278.00.The Company, with support of Van Lanschot Kempen N.V., has now successfully applied for the admission of these new shares to collective safe custody with Nederlands Centraal Instituut voor Giraal Effectenverkeer B.V., trading as Euroclear Nederland as well as to trading on Euronext Amsterdam (the "Listing").

For the Listing, an EU Recovery prospectus has been prepared in accordance with, Article 14a of the Prospectus Regulation (as amended by the Regulation (EU) 2021/337 of the European Parliament and of the Council of 16 February 2021).

In addition, as previously announced, the Investors have the option to purchase, in aggregate, up to another 2,054,796 shares during a period ending twelve months after the date of the approval of the EU Recovery prospectus or three months after the achievement date of a defined clinical milestone, whichever is later, at a price of EUR 7.30 per share.