NeoImmuneTech Receives Notice of Approval from the Korea Exchange for Initial Public Offering on the KOSDAQ

On December 30, 2020 NeoImmuneTech, Inc. (NIT), a clinical-stage T cell focused biopharmaceutical company, reported it has received notice of approval from the Korea Exchange (KRX) for its initial public offering (IPO) on the Korean Securities Dealers Automated Quotations (KOSDAQ) (Press release, NeoImmuneTech, DEC 30, 2020, View Source [SID1234573339]). NIT is planning to complete the IPO process in early 2021.

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NIT was established in 2014 and is headquartered in Rockville, Maryland, with offices in Pangyo, South Korea and a Research Institute in Pohang, South Korea. The company is led by the scientific founder and inventor of its lead drug candidate, NT-I7, and a strong executive team with rich industry experience. NIT is dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases.

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7. It is being studied in multiple clinical trials in solid tumors and infectious diseases (such as COVID-19), and as a vaccine adjuvant. Several of these studies are being conducted under clinical collaboration agreements with global industry leaders in immuno-oncology, including Roche, Bristol Myers Squibb, and Merck.

"This IPO opportunity would allow us to further enhance our competitiveness by expanding our already robust clinical program for NT-I7," said Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech. "We have full confidence in NT-I7’s potential to transform the treatment of cancer, as well as many other diseases where amplifying and improving the functionality of the T cells could provide greater clinical benefit."

CEL-SCI Reports Fiscal 2020 Financial Results and Clinical & Corporate Developments

On December 30, 2020 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2020, as well as key clinical and corporate developments (Press release, Cel-Sci, DEC 30, 2020, View Source [SID1234573338]).

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Clinical and Corporate Developments included:

During fiscal 2020, the Independent Data Monitoring Committee (IDMC) for the Company’s pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Injection) conducted an official review of the study data in October 2019 and April 2020, and recommended in each case that the trial continue until the appropriate number of events has occurred. CEL-SCI announced in early May 2020 that the study reached the targeted threshold of 298 events (deaths) required to conduct the data evaluation and the process of data lock commenced. In December 2020, the study entered its final stage of statistical analysis of all study data.
In preparation for potential marketing clearance, CEL-SCI began expanding and upgrading its dedicated cGMP facility in which it manufactures Multikine. The construction will double the facility’s capacity, accommodating two shifts for increased production of Multikine.
CEL-SCI initiated the development of an immunotherapy with the potential to treat COVID-19 using the Company’s patented LEAPS peptide technology and signed a collaboration agreement with the University of Georgia (UGA) Center for Vaccines and Immunology to develop its LEAPS COV-19 immunotherapy during fiscal 2020. Following the end of fiscal 2020, in December 2020, CEL-SCI announced that its LEAPS COV-19 peptides, delivered as a therapeutic treatment following SARS-CoV-2 virus challenge, achieved a 40% survival rate in human ACE2 transgenic mouse models as compared to 0% survival in the two control groups in studies conducted at UGA Center for Vaccines and Immunology.
The LEAPS platform technology was issued a patent from the European Patent Office titled "Method of Preparation and Composition of Peptide Constructs for Treatment of Rheumatoid Arthritis". In addition to the treatment of COVID-19, the LEAPS platform technology is being developed as a potential therapeutic vaccine for rheumatoid arthritis supported by grants from the U.S. National Institutes of Health (NIH).
CEL-SCI raised net proceeds of approximately $25.8 million during fiscal 2020 through the sale of common stock and the exercise of warrants and options. In December 2020, following the end of the 2020 fiscal year, CEL-SCI raised an additional $14.7 million.
"The aim of our Phase 3 pivotal study is to show that our immunotherapy Multikine can help head and neck cancer patients when administered right after diagnosis, before surgery, radio and chemotherapy have weakened the immune system. After a decade of running the world’s largest Phase 3 study in head and neck cancer, we are looking forward to hearing the final study results which will hopefully prove our concept. We are grateful to all the stakeholders who have patiently been on this long journey with us," stated CEL-SCI CEO, Geert Kersten.

"While Multikine in the treatment of head and neck cancer is our immediate focus and opportunity, based on Phase 3 results, we may evaluate Multikine for the treatment of other cancers, concurrent with advancing our LEAPS therapeutic vaccine platform in COVID-19 and rheumatoid arthritis," Kersten concluded.

CEL-SCI reported a net loss of $30.3 million in fiscal year 2020 versus a net loss of $22.1 million in fiscal year 2019. The increase in net loss was predominantly due to an increase in research and development expenses by approximately $5.2 million, or 41%, and an increase in general and administrative expenses by approximately $3.7 million, or 46%, compared to the year ended September 30, 2019.

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study CEL-SCI treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine* first, BEFORE they received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has received Orphan Drug designation from the FDA for the neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the study’s protocol, newly diagnosed patients with advanced primary squamous cell carcinoma of the head and neck were treated with the Multikine treatment regimen right after diagnosis and prior to receiving the Standard of Care (SOC), which involves surgery, radiation or concurrent radiochemotherapy. Multikine is designed to help the immune system "see" the tumor at a time when the immune system is still relatively intact and thereby thought to better be able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the body’s immune system prior to SOC to attack the cancer. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 events have occurred among the two main comparator groups. This study milestone occurred in late April 2020. The study is currently in the statistical analysis phase.

The Company’s LEAPS technology is being developed for rheumatoid arthritis and as a potential treatment for COVID-19 infection. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

The Company’s audited financial statements contained an audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to the Company’s ability to continue as a going concern.

Cyclacel Pharmaceuticals to Present at Biotech Showcase™ Digital 2021

On December 30, 2020 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that the Company will present at Biotech Showcase Digital 2021 (Press release, Cyclacel, DEC 30, 2020, View Source [SID1234573337]). The conference is taking place online between January 11-15 and will feature prerecorded sessions of company presentations. Spiro Rombotis, President & Chief Executive Officer, will provide an overview of the Company and progress in key programs.

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Cyclacel will host one-on-one meetings with investors and industry stakeholders during the event. Registered Biotech Showcase Digital 2021 attendees may request one-on-one meetings with Cyclacel through the partneringONE system.

A live webcast of the presentation will be available through the Company’s website: www.cyclacel.com. The webcast will be archived for 90 days.

Entry into a Material Definitive Agreement

On December 30, 2020, The Board of Directors (the "Board") of INmune Bio Inc., a Nevada corporation (the "Company"), approved and adopted a Rights Agreement, dated as of December 30, 2020 (the "Rights Agreement"), by and between the Company and VStock Transfer, LLC,, as rights agent. Pursuant to the Rights Agreement, the Board declared a dividend of one preferred share purchase right (each, a "Right") for each outstanding share of common stock, par value $0.001 per share, of the Company (each, a "Common Share" and, collectively, the "Common Shares") (Filing, 8-K, INmune Bio, DEC 30, 2020, View Source [SID1234573333]). The Rights are distributable to stockholders of record as of the close of business on January 11, 2021 (the "Record Date"). One Right also will be issued together with each Common Share issued by the Company after January 11, 2020, but before the Distribution Date (as defined below) (or the earlier redemption or expiration of the Rights) and, in certain circumstances, after the Distribution Date.

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Generally, the Rights Agreement works by causing substantial dilution to any person or group that acquires beneficial ownership of twenty percent (20%) or more of the Common Shares without the approval of the Board. As a result, the overall effect of the Rights Agreement and the issuance of the Rights may be to render more difficult or discourage a merger, tender or exchange offer or other business combination involving the Company that is not approved by the Board. The Rights Agreement is not intended to interfere with any merger, tender or exchange offer or other business combination approved by the Board. The Rights Agreement also does not prevent the Board from considering any offer that it considers to be in the best interest of its stockholders.

The following is a summary description of the Rights and material terms and conditions of the Rights Agreement. This summary is intended to provide a general description only, does not purport to be complete and is qualified in its entirety by reference to the complete text of the Rights Agreement, a copy of which is filed as Exhibit 4.1 to this Current Report on Form 8-K and incorporated herein by reference. All capitalized terms used but not defined herein shall have the meanings ascribed to such terms in the Rights Agreement.

The Rights

Subject to the terms, provisions and conditions of the Rights Agreement, if the Rights become exercisable, each Right would initially represent the right to purchase from the Company one one-thousandth of a share of a newly-designated series of preferred stock, Series A Junior Participating Preferred Stock, par value $0.001 per share, of the Company (each, a "Series A Preferred Share" and, collectively, the "Series A Preferred Shares"), at an exercise price of $300 per one one-thousandth of a Series A Preferred Share, subject to adjustment (the "Exercise Price"). If issued, each one one-thousandth of a Series A Preferred Share would give the stockholder approximately the same dividend, voting and liquidation rights as does one Common Share. However, prior to exercise, a Right does not give its holder any rights as a stockholder of the Company, including, without limitation, any dividend, voting or liquidation rights. A copy of the Certificate of Designation of Series A Junior Participating Preferred Stock (the "Series A Certificate of Designation") that the Company intends to file with the Secretary of State of the State of Nevada on December 30 2020 to designate the Series A Preferred Shares is filed as Exhibit 3.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Initial Exercisability

Initially, the Rights will not be exercisable, certificates will not be sent to stockholders and the Rights will automatically trade with the Common Shares. Until the Rights separate from the Common Shares and become exercisable (or the earlier redemption or expiration of the Rights), the Rights will be evidenced by Common Share certificates, Rights relating to any uncertificated Common Shares that are registered in book entry form will be represented by a notation in book entry on the records of the Company, and the surrender for transfer of any Common Shares will also constitute the transfer of the associated Rights.

Subject to certain exceptions specified in the Rights Agreement, the Rights will separate from the Common Shares and become exercisable following the earlier to occur of the tenth (10th) business day (or such later date as may be determined by the Board) after (i) the day on which a public announcement or filing with the Securities and Exchange Commission (the "SEC") is made indicating that a person has become an Acquiring Person (as defined below) or that discloses information that reveals the existence of an Acquiring Person (the "Shares Acquisition Date"), or (ii) the commencement by any person (other than certain exempted persons) of, or the first public announcement of the intent of any person (other than certain exempted persons) to commence, a tender or exchange offer by or on behalf of a person, the successful consummation of which would result in any person (other than certain exempted persons) becoming an Acquiring Person, irrespective of whether any shares are actually purchased or exchanged pursuant to such offer (the earlier of these dates is called the "Distribution Date").

After the Distribution Date, separate rights certificates will be issued and the Rights may be transferred other than in connection with the transfer of the underlying Common Shares unless and until the Board has determined to effect an exchange pursuant to the Rights Agreement (as described below).

Acquiring Person

Under the Rights Agreement, an Acquiring Person is any person who or that, together with all Affiliates and Associates (as defined in the Rights Agreement) of such person, from and after the first public announcement by the Company of the adoption of the Rights Agreement, is or becomes the beneficial owner of twenty percent (20%) or more of the Common Shares outstanding, subject to various exceptions. For purposes of the Rights Agreement, beneficial ownership is defined to include the ownership of derivative securities.

The Rights Agreement provides that an Acquiring Person does not include the Company, any subsidiary of the Company, any employee benefit plan of the Company or any subsidiary of the Company, or any person organized, appointed, or established to hold Common Shares pursuant to any employee benefit plan of the Company or for the purpose of funding any such plan.

The Rights Agreement also provides that the following persons shall not be deemed an Acquiring Person thereunder: (i) any person who becomes the beneficial owner of twenty percent (20%) or more of the shares of Common Stock of the Company then outstanding solely as a result of the initial grant or vesting of any options, warrants, rights or similar interests (including restricted shares and restricted stock units) by the Company to its directors, officers and employees pursuant to any employee benefit or stock ownership plan of the Company, or the acquisition of shares of Common Stock of the Company upon the exercise or conversion of any such securities so granted; (ii) any person who as the result of an acquisition of shares of Common Stock by the Company (or any subsidiary of the Company, or any person organized, appointed, established or holding shares of Common Stock of the Company for or pursuant to the terms of any such plan) that, by reducing the number of shares of Common Stock of the Company outstanding, increases the proportionate number of shares of Common Stock of the Company beneficially owned by such person to twenty percent (20%) or more of the Common Shares then outstanding; (iii) any person who or that became the beneficial owner of twenty percent (20%) or more of the Common Shares then outstanding as a result of the acquisition of Common Shares directly from the Company; or (iv) any person who or that would otherwise be an Acquiring Person who or that the Board determines had become such inadvertently (including, without limitation, because (A) such person was unaware that it beneficially owned a percentage of the Common Shares that would otherwise cause such person to be an "Acquiring Person," or (B) such person was aware of the extent of its beneficial ownership of Common Shares but had no actual knowledge of the consequences of such beneficial ownership under the Rights Agreement), and who or that thereafter within five (5) business days of being requested by the Company, reduces such person’s beneficial ownership to less than twenty percent (20%) of the Common Shares then outstanding.

Entry into a Material Definitive Agreement

On December 30, 2020, Lumos Pharma, Inc. (the "Company") reported that it entered into a Controlled Equity OfferingSM Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co., as agent (the "Agent"), pursuant to which the Company may offer and sell from time to time through the Agent up to $50.0 million of shares of the Company’s common stock, $0.01 par value (the "Shares") (Filing, 8-K, NewLink Genetics, DEC 30, 2020, View Source [SID1234573332]). The offering and sale of the Shares has been registered under the Securities Act of 1933, as amended (the "Securities Act"), pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-226366) (the "Registration Statement"), which was originally filed with the Securities and Exchange Commission ("SEC") on July 26, 2018 and declared effective by the SEC on July 22, 2019, the base prospectus contained within the Registration Statement, and a prospectus supplement that was filed with the SEC on December 30, 2020.

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Under the Sales Agreement, the Agent may sell the Shares by any method permitted by law and deemed to be an "at-the-market" offering as defined in Rule 415(a)(4) promulgated under the Securities Act, including sales made directly on or through The Nasdaq Global Market, on any other existing trading market for the Shares, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices and/or any other method permitted by law. The Company will notify the Agent of the number of Shares to be issued, the time period during which sales are requested to be made, any limitation on the number of Shares that may be sold in any one day and any minimum price below which sales may not be made. The Company intends to use the proceeds of the offering as described in the prospectus supplement.

The Sales Agreement contains customary representations, warranties and agreements by the Company, as well as indemnification and contribution obligations of the Company for certain liabilities under the Securities Act. Under the terms of the Sales Agreement, the Company will pay the Agent a commission of up to 3.0% of the gross sales price of the Shares sold through it under the Sales Agreement. In addition, the Company has agreed to reimburse certain expenses incurred by the Agent in connection with the offering.

The Company is not obligated to make any sales of the Shares under the Sales Agreement. The Sales Agreement may be terminated by the Agent or the Company at any time upon notice to the other party, as set forth in the Sales Agreement, or by the Agent at any time in certain circumstances, including the occurrence of a material and adverse change in the Company’s business or financial condition that makes it impractical or inadvisable to market the shares or to enforce contracts for the sale of the Shares.

The foregoing description of the material terms of the Sales Agreement is not intended to be complete and is qualified in its entirety by reference to the Sales Agreement, which is filed herewith as Exhibit 10.1 and incorporated herein by reference.

Wilson Sonsini Goodrich & Rosati P.C., counsel to the Company, has issued a legal opinion relating to the Shares. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of these securities 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.