Histogen Announces Closing of $4.5 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules

On November 16, 2020 Histogen Inc. (Nasdaq: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported the closing of its previously announced registered direct offering for the issuance and sale of 2,522,784 shares of its common stock, at a purchase price of $1.78375 per share (Press release, Conatus Pharmaceuticals, NOV 16, 2020, View Source [SID1234571139]). Histogen has also issued to investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 1,892,088 shares of its common stock. The offering was priced at-the-market under Nasdaq rules.

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

The warrants have an exercise price of $ 1.70 per share, are exercisable immediately and will expire five and one-half years from the date of issuance.

The gross proceeds from this offering were approximately $4.5 million, before deducting placement agent’s fees and other offering expenses. Histogen intends to use the net proceeds from this offering for working capital and general corporate purposes, including expenses related to the clinical development of its products for its CCM, hECM and HSC programs, further research and development, capital expenditures and general and administrative expenses.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) were offered by Histogen pursuant to a "shelf" registration statement on Form S-3 (File No. 333-248074) previously filed with the Securities and Exchange Commission (the "SEC") on August 17, 2020 and declared effective by the SEC on August 26, 2020. The offering of the shares of common stock only was made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock was filed with the SEC and is available on the SEC’s website at View Source Electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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

NeoImmuneTech Receives U.S. FDA IND Clearance for Phase 2 Study of NT-I7 (efineptakin alfa) in combination with PD-L1 checkpoint inhibitor in First-line Non-small Cell Lung Cancer

On November 16, 2020 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for the combination of its lead drug candidate, NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), and atezolizumab (Tecentriq) for the treatment of patients with previously untreated, PD-L1-expressing, locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, NeoImmuneTech, NOV 16, 2020, View Source [SID1234571159]). This IND clearance allows NeoImmuneTech (NIT) to initiate a multicenter Phase 2 study evaluating the anti-tumor efficacy and safety of NT-I7 in combination with atezolizumab as a first-line (1L) treatment for NSCLC.

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NSCLC accounts for 80-85% of all cases of lung cancer, which is the most commonly diagnosed cancer worldwide, with an estimated 2.1 million new cases in 2018 globally. It is also the leading cause of cancer death in most countries, with an estimated 1.76 million lung cancer deaths occurred in 2018 worldwide. Atezolizumab monotherapy has been approved as 1L treatment for metastatic NSCLC patients with high PD-L1 expression, while the combinations of atezolizumab with chemotherapies and with or without bevacizumab (Avastin) have been approved for 1L treatment of metastatic non-squamous NSCLC regardless of PD-L1 expression.

"There is a clear need for new chemo-free treatment options for patients with NSCLC, and we are pleased to combine our NT-I7 with one of the field’s leading cancer therapeutics as a potential treatment for 1L NSCLC," said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NIT. "NT-I7 has the potential to address multiple immune resistance mechanisms; therefore, we believe that adding NT-I7 to atezolizumab may provide clinical benefit to NSCLC patients with lower level of PD-L1 expression as well as increase the depth and breadth of the response to single-agent atezolizumab."

Se Hwan Yang, Ph.D., President and Chief Executive Officer of NIT, added "NT-I7’s unique ability to amplify and increase the functionality of T cells and exhibition of favorable safety profile make it an excellent combination partner with atezolizumab. Based on strong scientific rationale and preclinical data, we anticipate that this chemo-free combination therapy could significantly improve clinical outcomes for NSCLC patients who do not benefit from or cannot tolerate currently available treatments."

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

Q BioMed’s Uttroside-B Receives U.S. Patent in Treatment of Liver Cancer

On November 16, 2020 Q BioMed Inc. (OTCQB: QBIO), reported that it has received a patent from the U.S. Patent and Trademark Office for its Uttrocide-B molecule (Press release, Q BioMed, NOV 16, 2020, View Source [SID1234571182]). The Patent is titled "Uttroside-B and Derivatives Thereof as Therapeutics for Hepatocellular Carcinoma". Q BioMed has the exclusive rights to the technology through an agreement with the Rajiv Gandhi Centre for Biotechnology, an Autonomous Institute under the Department of Biotechnology, Government of India and the Oklahoma Medical Research Foundation. The Method Of Use patent covers the use of a novel pharmaceutical for the treatment of hepatocellular carcinoma. International and additional U.S. claims are currently under prosecution for the technology which addresses a severe unmet need for a safe and effective drug to treat hepatocellular carcinoma (HCC), the most common form of liver cancer.

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"This patent allowance in the U.S. comes at an opportune time as we are scaling up manufacturing and preparing Uttroside-B for an investigational new drug (IND) application with the U.S. FDA. Upon the FDA’s clearance, we anticipate initiating proof of concept studies by the end of next year," stated Q BioMed CEO Denis Corin.

Uttroside-B has shown ten times the potency against HCC as compared to the current standard of care drug in early pre-clinical investigation. Currently, there are only two approved first-line therapies for HCC. Challenges with current treatments include patients becoming resistant to the specific drugs, adverse side effects, and high costs. An estimated 700,000 people are diagnosed with HCC each year, with the global market for liver cancer drugs expected to grow to $3.9 billion by 2027.

Entry into a Material Definitive Agreement

On November 16, 2020, Medgenics Medical Israel Ltd. ("Medgenics"), a subsidiary of Cerecor Inc. (the "Company"), reported that it entered into a sixth amendment to that certain Sponsored Research Agreement, dated as of November 12, 2014, by and between Medgenics and Children’s Hospital of Philadelphia ("CHOP") (as amended, the "SRA") and a sixth amendment to that certain License Agreement, dated as of November 12, 2014, by and between Medgenics and CHOP (as amended, the "License Agreement"), which modified the term of the SRA and certain of Medgenics’ exclusive rights under the License Agreement (collectively, the "Amendments") (Filing, 8-K, Cerecor, NOV 16, 2020, View Source [SID1234573111]). Pursuant to the amended SRA, the term of the SRA is extended to January 15, 2021, and may be extended for additional terms ending on each of June 30, 2021, 2022 and 2023, if the Company provides written notice to CHOP of such extension, and a commitment to fund at set amounts, by January 15, 2021 (for the January 16, 2021 to June 30, 2021 term), March 30, 2021 (for the July 1, 2021 to June 30, 2022 term) and March 20, 2022 (for the July 1, 2022 to June 30, 2023 term). Pursuant to the amended License Agreement, the Company has the option to extend the term during which it is granted certain exclusive rights under the License Agreement to match the then-current term of the SRA. In addition, the License Agreement was amended to adjust the field in which Medgenics has exclusive rights and clarify payment obligations of Medgenics to CHOP in respect of the Company’s anti-LIGHT monoclonal antibody, CERC-002. Pursuant to the terms of the Amendments, the Company is obligated to pay to CHOP (i) $125,000 within ten days of entry into the Amendments, (ii) $1,500,000 for sponsored research during each of the periods July 1, 2020 through January 15, 2021 and January 15, 2021 through June 30, 2021, (iii) $3,000,000 for each of the periods July 1, 2021 through June 30, 2022 and July 1, 2022 through June 30, 2023 and (iv) $125,000 under the License Agreement each time that the Company exercises its extension option.

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Nick Staples appointed as interim CEO and Jon Moore as NED

On November 16, 2020 Avvinity Therapeutics Limited ("Avvinity"), an immuno-oncology company developing Alphamer immunotherapies for solid and haematological cancers, reported the appointments of Nick Staples as interim CEO and Jon Moore as Non-Executive Director (Press release, Avvinity Therapeutics, NOV 16, 2020, View Source [SID1234571107]).

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Avvinity’s proprietary Alphamer immunotherapy platform harnesses a novel and powerful immune adaptation found in certain primates (including humans) to selectively kill cancer cells. Having recently attracted early stage funding from LifeArc and the UK Government’s Future Fund, the company is set to deliver key in vivo studies for its novel EGFR targeted Alphamer program, ahead of a planned Series A fundraise in 2021.

As interim CEO, Dr Nick Staples brings strong biotech leadership experience gained over 20 years in private and public life science companies and the capital markets. Nick has a proven track record in all aspects of corporate development, having raised over £150 million in private and public fundraises to date and successfully completed a number of M&A and partnering transactions, start-ups and joint ventures.

Previously, Nick was CEO at Locate Bio where he was responsible for leading a new cell and gene therapy strategy. He also served as CBO at Artios Pharma, a leading DDR oncology company which he helped establish as a venture backed spin out from CRUK, and CBO at TopiVert Pharma, a clinical stage biotech company. Earlier in his career, Nick held senior corporate and business development roles at Vectura plc, SSL International plc and Protherics plc.

Nick Staples, interim CEO said: "I am excited to be joining Avvinity at this crucial time, with forthcoming in vivo results enabling a Series A fundraise in 2021 to progress its lead program to the clinic".

Dr Jon Moore was a co-founder of Avvinity Therapeutics and he has been with the company since its foundation. Jon is currently an Operating Partner at Advent Life Sciences, having previously served as CSO of Horizon Discovery plc and as Head of Biology at Vernalis plc.

Jon Moore, Non-Executive Director said: "Having been part of the Avvinity journey since its inception, I am tremendously excited at the prospect of using Alphamers as novel immunotherapeutics to treat cancers, and also potentially in other diseases in conjunction with partners."

Nick Higgins, Chairman said: "I am delighted that Nick has joined Avvinity as its interim CEO and similarly that Jon will be continuing to support the company as a non-executive director. The company has made tremendous progress over the last 18 months and we are looking forward to receiving key in vivo data for our novel EGFR-targeted Alphamer immunotherapy in the coming months."