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Entry into a Material Definitive Agreement

On December 16, 2022, Humanigen, Inc. (the "Company"), and Catalent Pharma Solutions, LLC ("Catalent") reported that it has entered into a Settlement Agreement (the "Settlement Agreement") resolving certain previously reported disputes between the Company and Catalent that had arisen under the Multiple Facility Clinical Supply and Services Agreement (the "MSA") dated July 31, 2020, by and between Catalent and the Company, pursuant to which Catalent had agreed to perform certain services relating to the manufacturing of lenzilumab, the Company’s lead product candidate (Filing, 8-K, Humanigen, DEC 16, 2022, View Source [SID1234625539]).

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Pursuant to the Settlement Agreement, the Company agreed to make a one-time payment of $12 million (the "Settlement Payment") to Catalent in full satisfaction of all of the Company’s payment obligations under the MSA for products and prior services, as well as cancellation fees Catalent claimed to be owed. In consideration of its receipt of the Settlement Payment, which the Company made on December 22, 2022, Catalent waived and released Catalent’s rights to pursue all payments, claims, or invoices for such products and services and cancellation fees, as well as for some limited additional work to be performed by Catalent, quantified at approximately $23.5 million in the aggregate.

The terms and conditions of the MSA generally will remain in full force and effect with respect to any ongoing activities and additional work to be performed by Catalent.

The foregoing description of the material terms of the Settlement Agreement does not purport to be complete and is qualified in its entirety by reference to the Settlement Agreement, to be filed with the Securities and Exchange Commission as an exhibit to the Company’s 2022 Annual Report on Form 10-K.

Purchase Agreement Amendment

On December 16, 2022, Midatech Pharma PLC (the "Company") and a certain institutional investor (the "Investor") entered into a first amendment (the "Purchase Agreement Amendment") to the securities purchase agreement (the "Purchase Agreement"), dated as of December 13, 2022, by and between the Company and the Investor (Filing, 6-K, Midatech Pharma, DEC 19, 2022, View Source [SID1234625408]). Pursuant to the Purchase Agreement Amendment, the Company and the Investor agreed (i) to increase the exercise price of the Series A warrants and Series B warrants that are expected to be issued to the Investor at the second closing provided for therein (the "Second Closing") to $1.10; (ii) to change the purchase price of the Company’s American Depositary Shares expected to be issued to the Investor at the Second Closing to the lesser of (x) $1.00 or (y) 20-Day VWAP (as defined in the Purchase Agreement Amendment) minus 10.0%; (iii) that the Company may terminate the Purchase Agreement and the Registration Rights Agreement, dated as of December 13, 2022, by and between the Company and the Investor, if the 20-Day WVAP on the proposed date of the Second Closing is less than $1.00; and (iv) that the Investor shall not execute any short sales of the Company’s securities prior to the occurrence of the Second Closing.

In addition, on December 18, 2022, the Company and Bioasis Technologies Inc. ("Bioasis") entered into a first amendment (the "Arrangement Agreement Amendment") to the arrangement agreement (the "Arrangement Agreement"), dated as of December 13, 2022, by and between the Company and Bioasis. Pursuant to the Arrangement Agreement Amendment, the Company and Bioasis agreed that (i) the loan to Bioasis shall now be made in three tranches of $250,000 payable on each of December 19, 2022, January 3, 2023 and February 6, 2023 as opposed to one payment of the loan in full; and (ii) provide the Company the sole discretion to seek shareholder consent to the proposed cancellation of the Company’s ordinary shares to trading on AIM, a market of the London Stock Exchange.

The foregoing descriptions of the Purchase Agreement Amendment and Arrangement Agreement Amendment are not complete and are qualified in their entirety by reference to the full text of the form of Purchase Agreement Amendment and the Arrangement Agreement Amendment, which are filed as Exhibits 10.1 and 10.2, respectively, to this Report on Form 6-K and are incorporated by reference herein.

On December 19, 2022, the Company issued a press release announcing the closing of its previously announced registered direct offering and the amendments to the Purchase Agreement and Arrangement Agreement. A copy of such press release is attached as Exhibit 99.1 hereto and is incorporated herein by reference.

Zhejiang Doer Biotechnology Co., Ltd. Announces a Clinical Trial Collaboration with Merck to Evaluate the Clinical Efficacy of DR30303 in Combination with KEYTRUDA® (Pembrolizumab) in Patients with Gastric/GEJ Cancer

On December 16, 2022 Zhejiang Daoer Biotechnology Co., Ltd. A clinical-stage biopharmaceutical company developing innovative biotherapeutics, reported that a clinical trial collaboration agreement with Merck & Co. A clinical trial of combination therapy with Merck’s PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with gastric or gastroesophageal junction cancer (Press release, Doer Biologics, DEC 16, 2022, View Source [SID1234625370]).

According to the agreement, Daoer Bio will conduct clinical trials based on the clinical protocol agreed and finalized by both parties to evaluate the combination of DR30303 and KEYTRUDA in the treatment of Claudin18.2 positive, locally advanced unresectable or metastatic gastric cancer or gastroesophageal junction cancer (GC/ GEJ) patient safety and efficacy.

Dr. Huang Yanshan, founder and CEO of Doer Bio, said: "DR30303 is a humanized anti-Claudin18.2 single domain antibody Fc fusion protein developed by Doer Bio based on its proprietary SMART-VHHBody platform ( VHH-Fc). We believe that DR30303 exhibits strong affinity and highly selective binding to Claudin18.2, while enhancing antibody-dependent cellular cytotoxicity (ADCC) activity, and has a low risk of immunogenicity. Its small The molecular weight of DR30303 may allow DR30303 to penetrate into solid tumors faster and deeper. We believe that DR30303 may be a potential best-in-class anti-Claud in 18.2 antibody." Dr. Yong Liang, Chief Operating Officer of Doyle Bio, commented on this DAO: "DR30303 has demonstrated a favorable safety profile in ongoing monotherapy trials and an encouraging anti-tumor signal in patients with Claudin18.2-positive solid tumors. We are very excited to be exploring DR30303 with KEYTRUDA combination therapy for Claudin18.2-positive gastric cancer or gastroesophageal junction cancer (GC/GEJ) patients."

KEYTRUDA is a registered trademark owned by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Lowe, NJ, USA.

About DR30303

DR30303 is a humanized anti-Claudin18.2 single domain antibody Fc fusion protein (VHH-Fc) developed by Doyle Bio based on its proprietary SMART-VHHBody platform. Due to its tumor specificity and abnormally high expression in gastric and pancreatic cancers, Claudin18.2 is an attractive target for cancer therapy. DR30303 showed strong and highly selective binding to the Claudin18.2 target, enhanced antibody-dependent cellular cytotoxicity (ADCC) activity by engineering its Fc, and algorithm-based T cell epitope prediction showed its have a lower risk of immunogenicity. Preclinical studies have shown that DR30303 has shown strong anti-tumor activity and good pharmacokinetics when administered alone or in combination with chemotherapy drugs or PD-1 inhibitors in various mouse tumor models academic characteristics.

Personalis Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On December 16, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that the Compensation Committee of its Board of Directors granted, between the dates of December 5, 2022 and December 16, 2022, non-qualified stock options to purchase an aggregate of 35,000 shares of its common stock and restricted stock units (RSUs) covering an aggregate of 42,100 shares of its common stock to three new employees under Personalis’ 2020 Inducement Plan (Press release, Personalis, DEC 16, 2022, View Source [SID1234625368]).

The 2020 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee, or non-employee director, of Personalis, as an inducement material to such individual’s entering into employment with Personalis, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. Personalis is making this announcement as required by Nasdaq rules.

The inducement stock options have an exercise price of $2.83 per share, which is equal to the closing price of Personalis’ common stock on the date of grant, December 5, 2022, and will vest over four years, with 25% of the shares vesting on the first anniversary of the grant date and 1/48th of the remaining shares vesting monthly thereafter, subject to continued service through each applicable vesting date. The RSUs will vest over four years, with 25% of the shares vesting one year after the grant date and an additional 25% of the shares vesting annually thereafter, subject to continued service through each applicable vesting date. The options and RSUs are subject to the terms and conditions of Personalis’ 2020 Inducement Plan, and the terms and conditions of the applicable award agreement covering each grant.

Humanetics Corporation Presents at the MedInvest Oncology Investor Conference

On December 16, 2022 Humanetics Corporation, a clinical-stage pharmaceutical company focused on novel products to improve outcomes for patients with cancer, reported that it presented at the MedInvest Oncology Investor Conference in New York City on December 15, 2022 (Press release, Humanetics, DEC 16, 2022, View Source [SID1234625363]).

At the conference, Ronald Zenk, President and Chief Executive Officer at Humanetics, delivered a corporate overview and details on the company’s lead drug candidate, BIO 300. BIO 300 is a new class of drug focused on improving outcomes in cancer patients who receive first-line radiotherapy with or without concurrent chemotherapy. These patients suffer from myriad unintended side effects, which can reduce the efficacy of treatment and/or result in serious toxicities. BIO 300 acts to protect normal tissues, improving therapeutic outcomes.

BIO 300 is currently being evaluated in phase 2 clinical trials to prevent normal tissue injury resulting from cancer radiotherapy and to reduce lung damage in COVID-19 long haul patients. It is self-administered by patients in these trials as an oral liquid nanosuspension. BIO 300 also shows potential to minimize radiation damage in normal tissues without impacting the effectiveness of the radiation therapy against the tumor. BIO 300 was the recent subject of an early stage trial in non-small cell lung cancer patients undergoing chemoradiotherapy and was found to be safe, with results pointing to positive clinical outcomes.

Humanetics licensed BIO 300 from the United States Department of Defense (DOD), where it was discovered as a potent radioprotectant for warfighters on the battlefield. Its use in cancer patients is highly aligned with its military use, as it serves in both cases to protect normal tissues from radiation damage.