On December 15, 2020 Acacia Pharma Group plc ("Acacia Pharma", the "Group" or the "Company") (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures or cancer chemotherapy, reported an amendment to the terms of its investment agreement with Cosmo Technologies Ltd, a wholly-owned subsidiary of Cosmo Pharmaceuticals N.V. ("Cosmo") dated 10 January 2020 ("Investment Agreement") (Press release, Acacia Pharma, DEC 15, 2020, View Source [SID1234572844]).

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Under the Investment Agreement, Cosmo would have become eligible to receive a €5 million payment from the Company payable in new ordinary shares in the Company ("New Ordinary Shares") conditional upon the first commercial sale of the BYFAVO product in the United States ("BYFAVO First Commercial Sale").

On 14 December 2020, the Company and Cosmo entered into an amendment agreement (the "Amendment Agreement") pursuant to which the Company and Cosmo agreed that, in exchange for Cosmo prioritising the packaging and labelling production run for BYFAVO for supply in the US, the Company shall make the €5 million payment in advance of BYFAVO First Commercial Sale and by no later than 31 December 2020 (subject to the terms of the Investment Agreement, generally).

BYFAVO was approved by the US Food and Drug Administration (FDA) on 2 July 2020 for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. It received its Schedule IV designation from the US Drug Enforcement Administration (DEA) on 5 October 2020.

DEA scheduling requirements between July and October this year delayed the final approval and finalization of the BYFAVO label, leading Acacia Pharma to request Cosmo to prioritize the BYFAVO processing schedule during a time when its facility would typically be closed. The agreement to amend the timing for this payment was reached in consideration for Cosmo modifying its production schedule and expediting its packaging and labelling production for BYFAVO.

Acacia Pharma is preparing to launch BYFAVO in the US as soon as possible in the coming weeks.

"We are very excited to be able to bring BYFAVO to the US market," commented Mike Bolinder, Acacia Pharma’s CEO. "We are grateful to Cosmo for their flexibility and enthusiastic support to help us expedite the supply of BYFAVO into the US supply chain. We look forward to confirming the launch of BYFAVO in the coming weeks as it becomes available to physicians and their patients in the US."

Payment will be settled by the Company issuing new ordinary shares in the share capital of the Company (the "New Ordinary Shares") to Cosmo, at an issue price of €2.381 (being the 15-day volume weighted average price of the Company’s shares prior to the date of the Amendment Agreement). Listing and admission to trading of the New Ordinary Shares on Euronext Brussels remains, in accordance with the Investment Agreement, conditional upon the necessary regulatory approvals being obtained from the FCA and the Belgian FSMA. A further announcement will be made once approval has been obtained and admission of the New Ordinary Shares to trading on the regulated market of Euronext Brussels has become effective.

The New Ordinary Shares will rank pari passu in all respects with the Company’s existing ordinary shares in issue.

Following the issue of the New Ordinary Shares, the Company’s total issued share capital will comprise 89,597,951 ordinary shares with one voting right per share. The Company does not hold any ordinary shares in treasury. Therefore the total number of voting rights in the Company will be 89,597,951.

Following the issue of the New Ordinary Shares to Cosmo, Cosmo will hold 19,600,098 ordinary shares in the Company, representing a shareholding of 21.88% of the Company’s issued ordinary share capital.

On December 15, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported it has expanded its long-term strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson1 (Press release, Veracyte, DEC 15, 2020, View Source [SID1234572864]). The collaboration will include a focus on the NOBLE trial, a 9,000-patient, prospective, multicenter clinical study designed to distinguish genomic and other differences in lung cancer development and progression among patients with lung nodules detected by CT imaging.

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As Veracyte plans for the 2021 launch of the first noninvasive nasal swab test to guide the work-up of patients with potentially cancerous lung nodules, this new study will position the company to develop future tests that benefit broader patient populations, including nonsmokers and those with pre-cancerous changes who are likely to develop lung cancer.

"We are pleased to expand upon our collaboration in our goal of reducing lung cancer deaths," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "The NOBLE trial will provide a robust biorepository of genomic, clinical and outcome data, which we plan to translate into future tests that can help diagnose lung cancer at its earliest stages. It will also further our ability to address a nearly $40 billion global lung cancer market that is now more accessible to Veracyte through our own distributed testing platform, which enables advanced genomic testing to be performed locally by laboratories worldwide."

The NOBLE trial is a prospective, multicenter study involving up to 50 sites globally. It is anticipated to enroll 9,000 individuals with lung nodules detected through CT imaging either via lung cancer screening or incidentally and will include patients who are benign at initial nodule diagnosis but who subsequently develop lung cancer. Researchers will collect nasal-swab, longitudinal blood and other samples, as well as imaging and clinical information at enrollment and at multiple points throughout the study. Patients will be followed according to current guidelines for three years or until a lung cancer diagnosis.

"We are proud to participate in the NOBLE trial," said Kim Rieger-Christ, Ph.D., chief scientific officer and director of translational research at Lahey Hospital & Medical Center and the study’s principal investigator. "We believe this study will shed important new light on the natural progression of lung cancer and, more importantly, may enable development of new tests and treatments that will help physicians provide better care for patients and ultimately save more lives."

In January 2019, Veracyte announced a long-term strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable. The collaboration has focused on accelerating two key lung cancer programs for Veracyte: the commercialization of its Percepta Genomic Sequencing Classifier on the company’s RNA whole-transcriptome sequencing platform, which was achieved in June 2019, and the development of the first noninvasive nasal swab test for early lung cancer detection.

About Lung Cancer

Lung cancer is the deadliest cancer globally, killing more than 1.75 million people worldwide each year, according to the World Health Organization. Early detection is key, with a five-year survival rate of nearly 60 percent when the cancer is found early, compared to six percent when it is found at a later stage, according to the American Lung Association. Lung nodules are typically the first sign of lung cancer. While the vast majority of lung nodules ultimately prove to be benign, physicians currently lack clear diagnostic tools to determine which patients have cancer and which do not. This can lead to unnecessary invasive biopsies, which are costly and risky, as well as to delayed diagnosis and treatment.

On December 15, 2020 NANOBIOTIX (Paris:NANO) (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported the initial closing of its previously announced initial public offering on the Nasdaq Global Select Market by way of a capital increase of 7,300,000 new ordinary shares (the "New Shares"), consisting of a public offering of 5,445,000 ordinary shares in the form of American Depositary Shares ("ADSs"), each representing the right to receive one ordinary share, in the United States (the "U.S. Offering") and a concurrent offering of 1,855,000 ordinary shares in certain jurisdictions outside of the United States to certain investors (the "European Offering" and together with the U.S. Offering, the "Global Offering") (Press release, Nanobiotix, DEC 15, 2020, View Source [SID1234572882]). In addition, the underwriters for the Global Offering have exercised in full their option to purchase 1,095,000 additional ADSs at the same public offering price of $13.50 per ADS, with the closing for such additional ADSs expected to occur on December 18, 2020.

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Following the additional closing, the total number of ordinary shares issued amounts to 8,395,000, including 6,540,000 in the form of ADSs, bringing the gross proceeds of the Global Offering to approximately $113.3 million (€93.5 million1) and the aggregate net proceeds to Nanobiotix, after deducting underwriting commissions and estimated offering expenses payable by Nanobiotix, will be approximately $100.4 million(€82.8 million)2. All of the securities sold in the Global Offering were offered by Nanobiotix.

The Company intends to apply the net proceeds from the option to purchase additional ADSs on a pro rata basis to the use of proceeds identified with respect to the base offering. The Company believes that the net proceeds from the Global Offering, including the net proceeds from the option to purchase additional ADSs, together with its cash and cash equivalents, will be sufficient to fund its operations through the middle of the second quarter of 2023.

Nanobiotix’s ordinary shares are listed on the regulated market of Euronext in Paris under the ticker symbol "NANO". Nanobiotix’s ADSs began trading on the Nasdaq Global Select Market on December 11, 2020 under the ticker symbol "NBTX".

Jefferies LLC acted as global coordinator and joint book-running manager for the Global Offering, and Evercore Group, L.L.C. and UBS Securities LLC acted as joint book-running managers for the U.S. Offering. Gilbert Dupont acted as manager for the European Offering.

In accordance with Article 6 of delegated regulation EU 2016/1052 of March 8, 2016, Jefferies LLC, acting as the stabilizing agent on its own behalf and on behalf of the other underwriters, reported that no stabilization activities had been carried out. The period during which stabilization activities could be carried out is now closed.

The Global Offering was made only by means of a prospectus. A copy of the prospectus relating to the Global Offering was filed with the U.S. Securities and Exchange Commission and may be obtained from Jefferies LLC, 520 Madison Avenue New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; or from Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at 888-474-0200, or by email at [email protected]; or from UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, New York 10019, or by telephone at 888-827-7275, or by email at [email protected].

A registration statement relating to these securities has been filed with, and declared effective by, the U.S. Securities and Exchange Commission. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

On December 15, 2020 The Board of Directors of Alligator Bioscience AB (publ) ("Alligator" or the "Company") reported that based on the authorization from the Annual General Meeting on May 5, 2020, resolved to carry out a rights issue of shares with preferential rights for the Company’s existing shareholders of approximately SEK 86 million (the "Rights Issue") (Press release, Alligator Bioscience, DEC 15, 2020, View Source [SID1234572846]). The Company has received subscription undertakings from existing shareholders, including Stena AB, AP4, board members and Per Norlén, CEO. In total, subscription undertakings amount to approximately SEK 12.6 million, corresponding to approximately 15 percent of the Rights Issue. In addition, the Company has procured guarantee commitments of approximately SEK 73 million, which secures the Rights Issue to 100 percent. The guarantee commitments consist of a so-called top guarantee and a bottom guarantee. In addition to its subscription undertaking, the existing shareholder Roxette Photo NV will guarantee SEK 8.2 million of the top guarantee free of charge. Alligator will use the issue proceeds from the Rights Issue to start and run Phase II studies for mitazalimab as well as complete Phase I studies and begin work on Phase II studies for ATOR-1017. Due to the Rights Issue, the Board has resolved that the Company’s Year-End Report for 2020 will be published on February 26, 2021 instead of February 11, 2021.

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Background for and purpose of the Rights Issue
Alligator is active in the phases of drug development that range from idea and early research to clinical phase II studies in patients. This includes, among other things, identifying new points of attack for drugs, developing and optimizing new drug candidates, evaluating preclinical efficacy and safety, and finally confirming clinical studies on cancer patients.

Alligator’s clinical development portfolio consists of the drug candidates ATOR-1015, ATOR-1017, ALG.APV-527 and mitazalimab as well as the drug concept Neo-X-Prime, all intended for the treatment of disseminated cancer. During 2020, the Company has generated important data that will move the Company forward in the continued development of the clinical project portfolio.

The Phase I study with ATOR-1017 advanced faster than the Company expected and already in August 2020, interim data were presented that showed a good safety profile at clinically relevant dose levels. Dose evaluation will continue at higher dose levels and the Company expects to be able to present safety data and possible efficacy data in the spring of 2021, with the planned start of clinical phase II in the second half of 2021. Alligator has also shown strong Proof of Mechanism data for mitazalimab, Alligator’s most advanced immunology candidate. With a solid data package from two Phase I clinical trials with over 100 patients, the next step is to start a Phase II clinical trial.

Alligator is now focusing its resources on ATOR-1017 and mitazalimab and believes that both programs have first-in-class potential and can begin Phase II studies in 2021.

To ensure continued successful development in accordance with the Company’s business plan and strategy, Alligator has decided to carry out the Rights Issue of approximately SEK 86 million before issue costs, which are expected to amount to approximately SEK 10 million (of which costs for guarantee commitments amount to approximately SEK 4 million). Thus, the net proceeds from the Rights Issue are expected to amount to approximately SEK 76 million. The expected net proceeds from the Rights Issue will, in the following order of priority and with an approximate proportion indicated in parentheses, be used for:

1. Initiate and conduct phase II studies of mitazalimab (50%)

2. Complete phase I study and start work on phase II study for ATOR-1017 (50%)

Comment from Alligator’s CEO, Per Norlén
" The upcoming capital injection enables us to initiate both the mitazalimab Phase II study in pancreatic cancer as well as to advance ATOR-1017 into the planned Phase II study, with gastric cancer as a prioritized indication. The five-year survival rate for pancreatic cancer is today below ten percent. We have good faith in that mitazalimab can alter this, given the data at hand and the external validation of CD40 in patient studies. The ongoing safety study with ATOR-1017 confirms the drug candidate’s favorable properties and we have reached the expected therapeutic dose levels. We are now preparing to bring this candidate into the next phase of development, i. e clinical efficacy studies." – Per Norlén, CEO

The Rights Issue in summary
The Board has today, with the support of the authorization from the Annual General Meeting on May 5, 2020, resolved to carry out a Rights Issue. The Rights Issue shall be carried out on the following main terms:

Issue volume: The Rights Issue will amount to a maximum of 14,277,723 shares. Through the Rights Issue Alligator will initially receive approximately SEK 86 million before deductions of costs related to the Rights Issue.

Record date: The record date at Euroclear Sweden AB for determining which shareholders have the right to receive subscription rights falls on January 5, 2021. The last day for trading in the Company’s share, including the right to receive subscription rights, falls on December 30, 2020. First day for trading in the Company’s share excluding the right to receive subscription rights falls on January 4, 2021.

Subscription rights: The Rights Issue shall take place with priority for those who are registered as shareholders in the Company on the record date. One (1) existing share in the Company entitles to one (1) subscription right. Five (5) subscription rights entitle to subscribe for one (1) share. Subscription rights which are not exercised in the subscription period will be invalid and have no value

Trading in subscription rights: Trading in subscription rights takes place on Nasdaq Stockholm during the period from January 11 to January 25, 2021.

Subscription period: Subscription of shares shall take place during the period from and including January 11, 2021 to and including January 25, 2021. The Board has the right to extend the subscription period.

Subscription price: SEK 6.0 per share. No commission will be charged.

Trading in BTA: Trading in a paid subscription share (Sw. "BTA") takes place on Nasdaq Stockholm from January 11, 2021 until the Rights Issue is registered with the Swedish Companies Registration Office.

Allocation: If not all shares are subscribed for on the basis of subscription rights, the remaining shares shall be allotted within the framework of the maximum amount of the Rights Issue: firstly, to those who have subscribed for shares on the basis of subscription rights (regardless of whether they were shareholders on the record date or not) and who have registered an interest in subscribing for shares without the support of subscription rights and in the event that allotment cannot be made in full, allotment takes place pro rata in relation to the number of subscription rights that each of those who have expressed an interest in subscribing for shares without the support of subscription rights used for subscription of shares; secondly, to those who has subscribed for subscription of shares without the support of subscription rights and in the event that allotment to these cannot take place in full, allotment shall be made pro rata in relation to the number of shares that the subscriber has fully subscribed for; and thirdly, to those who have provided issue guarantees regarding subscription of shares, in proportion to such guarantee commitments. To the extent that allotment at any stage according to the above cannot take place pro rata, allotment shall be made by drawing lots.

Subscription undertakings and guarantee commitments
Alligator has received subscription undertakings from the Company’s existing shareholders, including Stena AB, Fjärde AP-fonden, board members and Per Norlén, CEO. In total, received subscription undertakings amount to approximately SEK 12.6 million, corresponding to approximately 15 percent of the Rights Issue. In addition, the Company has procured guarantee commitments in the form of a so-called bottom guarantee of approximately SEK 60.2 million, corresponding to approximately 70 percent of the Rights Issue, and a so-called top guarantee of approximately SEK 12.8 million, corresponding to approximately 15 percent of the Rights Issue. In addition to its subscription undertaking, the existing shareholder Roxette Photo NV will guarantee SEK 8.2 million of the top guarantee free of charge. The bottom-up guarantee ensures, provided that at least the corresponding subscription undertakings are subscribed for, that approximately 85 percent of the Rights Issue is subscribed for and paid for. The top guarantee ensures, provided that the subscription takes place at least corresponding to the subscription undertakings and the bottom guarantee, that 100 percent of the Rights Issue is covered by subscription undertakings and guarantee commitments.

Preliminary timeline

• December 30, 2020 – Last day of trading incl. preferential rights

•January 4, 2021 – First day of trading excl. preferential rights

•January 4, 2021 – Estimated publication of prospectus

•January 5, 2021 – Record date

• January 11 – January 21, 2021 – Trading in rights

•January 11 – January 25, 2021 – Subscription period

• January 11, 2021 – Until the Rights Issue is registered at the Swedish Companies Registration Office – Trading in paid subscription share (Sw. "BTA")

•January 28, 2021 – Estimated publication of outcome of Rights Issue

Number of shares and share capital
Upon full subscription in the Rights Issue, the number of shares in the Company will increase by 14,277,723 shares, from 71,388,615 to 85,666,338 and the share capital will increase by a maximum of SEK 5,711,089.20, from SEK 28,555,446 to SEK 34,266,535.20. The dilution effect for shareholders who chooses not to participate in the Rights issue will amounts to a maximum of approximately 16.67 percent of the share capital and votes, based on the number of shares and votes in the Company upon full subscription in the Rights Issue.

Prospectus
Full terms and conditions for the Rights Issue, as well as other information on the Company and information about subscription undertakings and guarantee commitments will be presented in the prospectus which the Company expects to publish on or about January 4, 2021 (the "Prospectus").

Investor meetings
Invitation to investor meetings will be sent out separately and will also be presented on Alligator and Redeye’s respective websites.

Postponing the Year-End Report for 2020
Due to the Rights Issue, the Board has resolved that the Company’s Year-End Report for 2020 will be published on February 26, 2021 instead of February 11, 2021.

Advisers
Redeye AB acts as financial adviser, Setterwalls Advokatbyrå AB acts as legal adviser and Aktieinvest FK AB acts as the issuing agent in the Rights Issue.

This information is information that Alligator Bioscience AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 08:00 a.m. CET on December 15, 2020.

On December 15, 2020 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) reported the closing of a second tranche under its April 7, 2020, securities purchase agreement (the "Purchase Agreement"), resulting in aggregate proceeds of up to $20.7 million in common stock and warrant investment by funds affiliated with an institutional investor (Press release, Idera Pharmaceuticals, DEC 15, 2020, View Source [SID1234572865]). Pursuant to the Purchase Agreement, under the second tranche Idera sold 2,747,252 shares of common stock (or common stock equivalents), together with accompanying warrants to purchase 1,373,626 shares of common stock, for aggregate gross proceeds of $5.0 million. The placement is exempt from the registration requirements of the Securities Act of 1933, as amended.

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"We believe this funding and other financial arrangements we have in place reflect optimism in the significant commercial opportunity for tilsotolimod, the most advanced TLR9 agonist therapy in development, to address the unmet medical need for patients living with anti-PD-1 refractory advanced melanoma and other difficult to treat tumor types," stated Vincent Milano, Chief Executive Officer of Idera. "It also provides us the potential cash runway to help make tilsotolimod, if approved, available to those patients."

The Company plans to use the $10.0 million in cash proceeds from the first and second tranches of this private placement to fund the completion of the ongoing ILLUMINATE-301 clinical trial and potential NDA filing of its lead product, tilsotolimod, for the treatment of anti-PD-1 refractory metastatic melanoma, and for general corporate purposes. The Company plans to use the subsequent proceeds of up to $10.7 million, if associated warrants are exercised, to fund the potential commercial launch of tilsotolimod, as well as the ongoing ILLUMINATE-206 trial exploring tilsotolimod in tumor types beyond melanoma and general corporate purposes.

The shares of common stock (or common stock equivalents) and warrants sold in the private placement have not been registered under the Securities Act of 1933, as amended, or under any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

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

About Tilsotolimod (IMO-2125)

Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate (Type-I IFN, antigen presentation) and adaptive (T cells) immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint inhibitors. For more information on tilsotolimod trials, please visit www.ClinicalTrials.gov.