Entry into a Material Definitive Agreement

On December 11, 2020, Seelos Therapeutics, Inc. (the "Company") reported that it entered into a Securities Purchase Agreement (the "Securities Purchase Agreement") with Lind Global Asset Management II, LLC (the "Investor") pursuant to which, among other things, on December 11, 2020, the Company issued and sold to the Investor, in a private placement transaction (the "Private Placement"), in exchange for the payment by the Investor of $10,000,000, (1) a convertible promissory note (the "Note") in an aggregate principal amount of $12,000,000 (the "Principal Amount"), which will bear no interest and mature on December 11, 2022 (the "Maturity Date"), and (2) 975,000 shares (the "Closing Shares") of common stock of the Company, par value $0.001 per share ("Common Stock") (Filing, 8-K, Apricus Biosciences, DEC 11, 2020, View Source [SID1234572982]).

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At any time following June 11, 2021, and from time to time before the Maturity Date, the Investor shall have the option to convert any portion of the then-outstanding Principal Amount of the Note into shares of Common Stock at a price per share of $1.60, subject to adjustment for stock splits, reverse stock splits, stock dividends and similar transactions (the "Conversion Price"). Prior to June 11, 2021, the Company shall have the right to prepay up to sixty-six and two-thirds percent (662/3%) of the then-outstanding Principal Amount of the Note with no penalty. On or after July 11, 2021, the Company shall have the right to prepay up to the then-outstanding Principal Amount of the Note with no penalty; however, if the Company exercises such prepayment right, the Investor will have the option to convert up to thirty-three and one-third percent (331/3%) of the amount that the Company elects to prepay at the Conversion Price.

The Company intends to use the proceeds from the Private Placement for general corporate purposes and to advance the development of its product candidates.

Subject to certain exceptions, the Company will be required to direct proceeds from any subsequent debt financings (including subordinated debt, convertible debt or mandatorily redeemable preferred stock but other than purchase money debt or capital lease obligations or other indebtedness incurred in the ordinary course of business) to repay the Note, unless waived by the Investor in advance.

Beginning on June 9, 2021, the Note will amortize in eighteen monthly installments equal to the quotient of (i) the then-outstanding Principal Amount of the Note, divided by (ii) the number of months remaining until the Maturity Date. All amortization payments shall be payable solely in cash, plus a 2% premium.

In conjunction with the Securities Purchase Agreement and the Note, on December 11, 2020, the Company and the Investor entered into a security agreement (the "Security Agreement"), which provides the Investor with a first priority lien on the Company’s assets and properties.

Until December 11, 2021, the Investor will, subject to certain exceptions, have the right to participate for up to 10% of any Common Stock equity financing of the Company.

The Securities Purchase Agreement contains customary representations and warranties of the Company and the Investor. In addition, the Note contains restrictive covenants and event of default provisions that are customary for transactions of this type.

The foregoing summaries of the Securities Purchase Agreement, the Note and the Security Agreement do not purport to be complete and are qualified in their entirety by reference to the copies of the Securities Purchase Agreement and Form of Note filed herewith as Exhibits 10.1, 4.1 and 10.2, respectively.

The representations, warranties and covenants contained in the Securities Purchase Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to the Securities Purchase Agreement, and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Securities Purchase Agreement is incorporated herein by reference only to provide investors with information regarding the terms of the Securities Purchase Agreement, and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the Securities and Exchange Commission (the "SEC").

Entry into a Material Definitive Agreement

On December 11, 2020, vTv Therapeutics LLC ("vTv LLC"), a controlled subsidiary of vTv Therapeutics Inc., reported that it entered into a License Agreement with Anteris Bio, Inc. ("Anteris") (the "Anteris License Agreement"), under which Anteris obtained a worldwide, exclusive and sublicensable license to develop and commercialize vTv LLC’s Nrf2 activator, HPP971 (Filing, 8-K, vTv Therapeutics, DEC 11, 2020, View Source [SID1234572873]).

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Under the terms of the Anteris License Agreement, Anteris will pay vTv LLC an initial license fee of $2.0 million. vTv LLC is eligible to receive additional potential development, regulatory, and sales-based milestone payments totaling up to $151 million. Anteris is also obligated to pay vTv royalty payments at a double digit rate based on annual net sales of licensed products. Such royalties will be payable on a licensed product-by-licensed product basis until the latest of expiration of the licensed patents covering a licensed product in a country, expiration of data exclusivity rights for a licensed product in a country, or a specified number of years after the first commercial sale of a licensed product in a country. In addition, vTv LLC received a minority ownership interest in Anteris.

Under the terms of the Anteris License Agreement, Anteris will be responsible for the development and commercialization of the licensed products, at its cost, and is required to use commercially reasonable efforts with respect to such development and commercialization efforts.

The Anteris License Agreement, unless terminated earlier, will continue until expiration of all royalty obligations of Anteris to vTv LLC. Either party may terminate the Anteris License Agreement for the other party’s uncured material breach. Anteris may terminate the Anteris License Agreement at will upon prior written notice. Either party may terminate the Anteris License Agreement for the other party’s insolvency.

The description of the Anteris License Agreement contained herein does not purport to be complete and is qualified in its entirety by reference to the Anteris License Agreement, a copy of which will be filed as an exhibit to the vTv Therapeutics Inc. Annual Report on Form 10-K for the year ending December 31, 2020.

Midatech Pharma PLC (“Midatech” or the “Company”) MTX110 Programmes to be Presented at The International Symposium on Pediatric Neuro-Oncology, Karuizawa, Japan (ISPNO 2020)

On December 11, 2020 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), an R&D biotechnology company focused on improving the bio‐delivery and biodistribution of medicines, reported that its University collaborators will be presenting three sets of research findings on MTX110 at The International Symposium on Pediatric Neuro‐Oncology on 13‐16 December 2020 in Karuizawa, Japan (to be held online this year) (Press release, Midatech Pharma, DEC 11, 2020, View Source [SID1234572861]). The first two presentations, by Columbia University Medical Center and University of Texas Health Center at Houston, are being presented for the first time. The third presentation, by the Pacific Pediatric Neuro‐Oncology Consortium, was also presented at last months’ Society of Neuro‐Oncology (SNO2020)
conference. Abstract details and links to the posters are provided below:

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A Phase I Study Examining the Feasibility of Intermittent Convection‐Enhanced Delivery (CED) of MTX110 for the Treatment of Children with Newly Diagnosed Diffuse Intrinsic Midline Gliomas (ABSTRACT DDEL‐07, Page iii284*) ‐ Lead Author: Dr Stergios Zacharoulis MD, Columbia University Medical Center, New York, USA. In the study:

Patients are receiving continuous CED infusions of MTX110 for 48 hours on two cycles separated by 5 to 7 days;
3 patients have been treated so far at 30 microM;
No Serious Adverse Events;
Toxicity: Grade II diplopia (1) Grade I sensation (n=1), headache Grade II (n=2); and
1 patient progressed 8 months post treatment

The presentation may be found at: View Source;phase‐i‐study‐examining‐the‐feasibility‐ofintermittent‐ convection‐enhanced‐delivery‐ced‐of‐mtx110‐for‐the‐treatment‐of‐childr/b4b8cf89e6‐ 1607680894/mtx110‐203_dipg_trial_‐dr_stergio_zacharoulis.pdf

High Dose MTX110 (Soluble Panobinostat) Safely Administered into the Fourth Ventricle in a Non‐Human Primate Model (ABSTRACT DDEL‐09, Page iii285*) ‐ Lead Author: Dr David Sandberg MD, McGovern Medical School, University of Texas Health Center at Houston, Houston, Texas, USA. Conclusions of the presentation are:

Fourth ventricle catheters were successfully instilled to enable locoregional infusion of MTX110;
MTX110 was well‐tolerated, with no evidence of toxicity;
Drug levels in the CNS reached a therapeutic range; and
The data support the safety of administration of MTX110 via the fourth ventricle
Clinical trial in recurrent medulloblastoma patients is ongoing (NCT04315064)

The presentation may be found at: View Source;dose‐mtx110‐soluble‐panobinostat‐safelyadministered‐ into‐the‐fourth‐ventricle‐in‐a‐non‐human‐primate‐model/df48e55757‐ 1607683538/mtx110_preclinical_safety_‐dr_david_sandberg.pdf

PNOC015: An Open Label Single Arm Phase I/II Study of MTX110 Delivered by Convection‐Enhanced Delivery (CED) in Patients with Diffuse Intrinsic Pontine Glioma (DIPG) Previously Treated with External Beam Radiation Therapy (ABSTRACT EPCT‐12, Page iii306*) Lead Author: Dr Sabine Mueller, Pacific Pediatric Neuro‐Oncology Consortium

The presentation may be found at: View Source;an‐open‐label‐single‐arm‐study‐of‐mtx110‐ delivered‐by‐convection‐enhanced‐delivery‐ced‐in‐patients‐with‐diffuse‐intrins/ee47f281a6‐1607683490/mtx110‐ 201_dipg_trial_‐dr_sabine_mueller.pdf

* Abstracts from the 19th International Symposium on Pediatric Neuro‐Oncology (ISPNO 2020), December 13‐16, 2020.
Neuro‐Oncology, Volume 22, Supplement 3 may be found at:
View Source

Commenting, Steve Damment, EVP R&D of Midatech, said: "These presentations by Midatech’s University collaborators
provide useful data points for our MTX110 programmes; the Columbia study in DIPG uses an implantable and
programmable pump to infuse drug without the need for repeated surgery, unlike the system deployed in the UCSF study
we recently reported; and, the Texas pre‐clinical safety study demonstrates the feasibility of fourth ventricle infusion, the
method of administration for our ongoing Phase I pilot study in recurrent medulloblastoma patients."

About MTX110

MTX110 is a water‐soluble form of panobinostat free base, achieved through complexation with hydroxypropyl‐β‐ cyclodextrin (HPBCD), that enables convection‐enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumour. Panobinostat is a hydroxamic acid and acts as a non‐selective histone deacetylase inhibitor (panHDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak) is not suitable for treatment of brain cancers owing to poor blood‐brain barrier penetration and inadequate brain drug concentrations. Based on favourable translational science data, MTX110 is being evaluated clinically as a treatment for DIPG (NCT03566199, NCT04264143) and recurrent medulloblastoma (NCT04315064), and preclinically for treatment of glioblastoma (SNO 2020 Abstract TMOD‐27). MTX110 is delivered directly into and around the patient’s tumour via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood‐brain barrier. This technique exposes the tumour to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG tumour cells in in vitro and in vivo models, and in a key study it was the most promising of 83 anticance

V2ACT Therapeutics™, LLC Announces FDA Clearance of an IND Application to proceed with a Phase 1/2a Study of V2ACT for the Treatment of Pancreatic Cancer

On December 11, 2020 V2ACT Therapeutics, LLC reported that the Company has obtained permission from the U.S. Food and Drug Administration (FDA) on an Investigational New Drug (IND) application and may proceed with the clinical investigation of V2ACT in a Phase 1/2a trial for the treatment of newly diagnosed surgically-resectable pancreatic cancer patients (Press release, V2ACT Therapeutics, DEC 11, 2020, View Source [SID1234572777]).

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"We are pleased the FDA cleared the IND for V2ACT for the treatment of pancreatic cancer within the initial 30-day review period," said Thomas Zindrick, J.D., President and CEO of V2ACT Therapeutics. "There is a serious unmet medical need for safer, more effective treatments to address this devastating disease and we believe that V2ACT has the potential to help patients in their fight."

"It is generally accepted there is no effective monotherapy for the treatment of pancreatic cancer, a devastating disease," said Gary Wood, Chief Science Officer of V2ACT Therapeutics. "V2ACT provides complementary immunotherapies in a unique process designed to transform non-immunoreactive pancreatic cancer into an immunoreactive ‘hot spot’ with cancer neoantigen-specific T cell infiltration and cancer cell killing. Therefore, V2ACT has the potential to effectively treat any type of cancer, even those considered to be resistant to immunotherapy."

Medivir strengthens its business development possibilities through a renegotiated agreement with TetraLogic regarding birinapant

On December 11, 2020 Medivir AB (Nasdaq Stockholm: MVIR) announced today that Medivir AB ("Medivir" or "the Company") has renegotiated its agreement with TetraLogic Pharmaceuticals Corporation ("TetraLogic") regarding financial obligations for birinapant, a SMAC mimetic, for the treatment of solid cancer tumors (Press release, Medivir, DEC 11, 2020, View Source [SID1234572709]). The purpose of the new agreement is to create improved business development opportunities.

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Medivir acquired birinapant from TetraLogic in 2016. The original agreement between Medivir and TetraLogic included milestone payments with predetermined amounts as well as royalty obligations to TetraLogic if and when Medivir develops, markets or out-licenses birinapant further. The original agreement has been dissolved and renegotiated so that the compensation Medivir is obliged to pay in a potential future transaction is now based solely on the distribution of actual future revenues to Medivir.

"It is very satisfying that we have now dissolved the previous agreement and negotiated a new agreement which is entirely based on the distribution of potential future revenues. This aligns and benefits both parties as the new agreement creates significantly improved conditions for a potential out-licensing or sale in our continued business development efforts with birinapant," says Yilmaz Mahshid, CEO Medivir AB.

Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.40 CET on 11 December, 2020.

About birinapant
Birinapant is being developed to enhance responses, and extend survival, of patients with solid tumors where existing treatments do not provide sufficient survival benefit, or where patients no longer have treatment options. Based on its unique design and mechanism, birinapant has the potential to enhance patients’ responses in combination with other treatments.