On March 23, 2021 Universal Diagnostics (UDX), an in-vitro diagnostics company developing minimally-invasive, blood-based solutions for detecting cancer early, reported that it has started a prospective, multi-center observational study in the US for its investigational advanced adenoma (precursor lesions) and colorectal cancer (CRC) detection blood test (Press release, Universal Diagnostics, MAR 23, 2021, View Source [SID1234577045]). UDX is performing this study to evaluate the performance of a preliminary panel of biomarkers for detecting colorectal cancer and advanced adenomas in the US population and to provide supporting data for the development of the final assay.

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The study, called USOPTIVAL, has been designed to collect blood samples and clinical data from 1,100 subjects, aged 45-84, who have a suspected advanced adenoma or have newly diagnosed with CRC scheduled for resection surgery. A second cohort of subjects who are at average-risk of CRC and are scheduled for routine colonoscopy examination will also be included. This prospective study will be performed at approximately 17 clinical sites. Further details about USOPTIVAL can be found here.

"The start of USOPTIVAL is our first in the US, so is an important milestone in the development of our blood test for adenomas and early-stage colorectal cancer. In addition, the study will enable us to build our clinical/medical network in preparation of our pivotal clinical study later," said Juan Martínez-Barea, Co-Founder and President of Universal Diagnostics. "USOPTIVAL is scheduled to be completed by the end of 2021, enabling us to conduct the pivotal study of our CRC/AA test."

About the Colorectal Cancer and Advanced Adenoma Test

UDX’s first product is a simple, non-invasive and accurate blood-based screening test that allows early-stage colorectal cancer detection and cancer prevention through advanced adenoma detection. Using profiling of DNA methylation changes in large number of tissue and plasma samples using next-generation sequencing (NGS) approach, UDX has identified and quantified a proprietary panel of biomarkers that has been combined into targeted assays that have shown 77% sensitivity for colorectal cancer, 62.5% sensitivity of adenomas and 88-90% specificity and tissue of origin accuracy across different verification studies.

On March 23, 2021 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported its financial results for the year ended December 31, 2020 (Press release, AC Immune, MAR 23, 2021, View Source [SID1234577010]). The Company also provided an overview of its execution strategy and anticipated clinical and preclinical milestones for 2021, as well as the strong progress being made across its broad portfolio of therapeutic and diagnostic product candidates.

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Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "We began 2021 with strong momentum based on the effective execution of our multi-pronged clinical development growth strategy. This is exemplified by our anti-pTau vaccine, which recently demonstrated highly potent immune responses against pathological Tau and remarkable safety in patients with early Alzheimer’s disease (AD). We are also creating future value by accelerating development of our proprietary, first-in-class candidates addressing novel targets in neurodegeneration, such as our promising alpha-synuclein PET tracer, which will generate initial clinical results this year, and our highly valued programs targeting the NLRP3 inflammasome. Our strong track record shows that expanding our efforts to advance these key early-stage programs may lead to multiple future opportunities for strategic partnership as well as in-house clinical development for select indications. In parallel, we continue to collaborate with our global partners to advance our later-stage clinical programs toward key inflection points. Looking forward in 2021, we expect to build upon our successes and continue innovating as a leader in precision medicine for neurodegenerative disease."

2020 and Q1 2021 Research & Development Highlights

Clinical Pipeline advancement

Reported promising interim Phase 1b/2a results for ACI-35.030, a novel anti-phospho-Tau (pTau) vaccine candidate showing strong safety and high titers of antigen-specific antibodies in 100% of older patients with early AD. The study is currently enrolling patients into the highest dose group, with further clinical readouts expected this year.
Advanced next-generation alpha-synuclein positron emission tomography (PET) tracer candidate, ACI-12589, into a first-in-human clinical study, with an expected data readout in Q3 2021
Reported topline Phase 2 results for semorinemab, the Company’s investigational monoclonal anti-Tau antibody candidate for the treatment of prodromal to mild AD, partnered with Genentech, a member of the Roche Group. These represent the first-ever Phase 2 results for an anti-Tau antibody therapeutic in AD. Primary completion of the second Phase 2 study in moderate AD patients is expected in Q2 2021.
Completed a Phase 1 clinical study in healthy volunteers for ACI-3024, an oral small molecule Morphomer Tau aggregation inhibitor, which achieved target brain exposure. The Companies have decided to pursue other promising Tau Morphomer candidates from AC Immune’s research platform for potential clinical development in AD. ACI-3024 will be further evaluated for efficacy in models of rare Tauopathies.
Partnership milestone payments and grants

Received a CHF 10 million milestone payment from Eli Lilly and Company related to ACI-3024
Amended the collaboration agreement with Lilly for Tau Morphomers to include a new CHF 60 million Phase 2 milestone payment, which increased the total potential deal value by CHF 40 million to CHF 1.86 billion
Received multiple prestigious and highly competitive grants in 2020 focused on acceleration of the Company’s proprietary and potentially game-changing diagnostic programs
Won Ken Griffin Alpha-synuclein Imaging Competition from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and is able to receive together with its clinical partner USD 3.2 million (CHF 3.1 million) to support AC Immune’s alpha-synuclein-PET tracers
Awarded a EUR 1.45 million grant to support the partnership between AC Immune and the EU Joint Programme – Neurodegenerative Disease Research (JPND) ImageTDP-43 Consortium to advance its first-in-class TAR DNA-binding protein 43 (TDP-43) PET tracers
Awarded a USD 600,000 grant from Target ALS to develop novel immuno-assays to detect pathological TDP-43 in cerebrospinal fluid (CSF) and blood based on AC Immune’s SupraAntigen-derived anti-TDP-43 antibodies
Strengthening of Management and Board

Appointed Prof. Johannes R. Streffer, former UCB Biopharma Head of Translational Neuroscience, to the new role of Chief Medical Officer
Welcomed Prof. Carl H. June, world authority on immune tolerance and adoptive immunotherapy, to the Company’s Board of Directors
Appointed renowned Neurologist with a specific focus in the emerging field of Down syndrome (DS)-related Alzheimer’s disease, Dr. Juan Fortea to AC Immune’s Clinical Advisory Board
Future Value Creation

Reported key advancements for several therapeutic programs targeting the NLRP3 inflammasome, including small molecule inhibitors, which showed the first evidence of in vivo activity in a model of peripheral inflammation, as well as high-affinity monoclonal antibodies that bind extracellular components of the (NOD)-like receptor protein 3 (NLRP3) pathway and inhibit inflammasome-mediated immune response in vitro
Identified and characterized the first biologically active small molecule Morphomer alpha-synuclein aggregation inhibitors, which significantly decreased alpha-synuclein aggregate formation in cellular assays by interfering with the fibrillation process
Strengthened strategic partnership with WuXi Biologics to accelerate advancement of TDP-43 antibody into clinical development for NeuroOrphan indications
2021 execution strategy to maximize value creation

AC Immune’s execution strategy is focused on three key initiatives, which support the Company’s overarching goal of enabling precision medicine for neurodegenerative diseases:

The Company plans to accelerate the development of its late-stage therapies in AD in collaboration with its strategic partners, including its novel pTau vaccine with Janssen Pharmaceuticals Inc., which continues to show great promise.
AC Immune is sharpening its strategic focus on non-AD indications with high unmet need. Currently this includes its anti-Abeta vaccine in people with DS, as well as its therapeutic and diagnostic candidates targeting TDP-43 and alpha-synuclein, where the Company may focus in-house efforts on select NeuroOrphan indications while seeking potential partnerships for larger indications like LATE (limbic-predominant age-related TDP-43 encephalopathy) and Parkinson’s disease (PD). Furthermore, AC Immune’s NLRP3 inflammasome-targeted programs have broad applicability both within central nervous system (CNS) and non-CNS indications.
The Company plans to accelerate advancement of its diagnostic candidates to late-stage development, as continued leadership in precision medicine is a key differentiator for AC Immune. These candidates include its Tau, alpha-synuclein, and TDP-43 PET tracers, which potentially enable earlier disease diagnosis, improved clinical trial outcomes and additional revenue generation for the Company.
Anticipated 2021 milestones
Clinical Milestones

ACI-35.030 anti-pTau vaccine: reported Phase 1b/2a in AD interim results in Q1 (second highest dose); further Phase 1b/2a interim analysis in Q4 (highest dose)
JACI-35.054 alternative anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2 (low dose)
Alpha-synuclein imaging agent: advanced third-generation candidate to first-in-human clinical study in Q1; readout expected in Q3
ACI-24 anti-Abeta vaccine in DS: reported Phase 1b top line results in Q1; to present further study results at the Alzheimer’s Association International Conference 2021 in Q2
ACI-24 in AD: reported Phase 2, 12-month interim analysis in Q1; 18-month interim analysis in Q2
Semorinemab anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in moderate AD in Q2
ACI-3024 small molecule Morphomer Tau aggregation inhibitor: select NeuroOrphan indication for further development in Q2
ACI-24 in DS: submit investigational new drug (IND) application for optimized vaccine formulation in Q4
Preclinical Milestones

Alpha-synuclein small molecule inhibitor: identified first biologically active small molecule in Q1; start in vivo proof-of-concept studies in Q3
TDP-43 imaging agent: initiate investigational new drug (IND)-enabling studies in Q3
Morphomer NLRP3-ASC: report in vivo proof-of-concept results in a non-CNS disease model and begin in vivo proof-of-concept studies with validated candidate in CNS in Q4
Anti NLRP3-ASC antibody: begin in vivo proof-of-concept studies in Q4
Anti-TDP-43 antibody: initiate IND-enabling toxicology studies in Q4
TDP-43 biofluid diagnostic: establish validation-ready assay in Q4
Therapeutic and Diagnostic Pipeline Overview

AC Immune also provided a comprehensive overview highlighting strong progress across its clinical and preclinical development pipeline. This supplemental material can be viewed and downloaded in the investor section of the Company’s website.

Analysis of Financial Statements for the year ended December 31, 2020

Cash Position: The Company had a total cash balance of CHF 225.9 million, comprised of CHF 160.9 million in cash and cash equivalents and CHF 65 million in short-term financial assets. This compares to a total cash balance of CHF 288.6 million as of December 31, 2019. The decrease of CHF 62.7 million is principally due to continued investments in our R&D pipeline. The total shareholders’ equity position decreased to CHF 215.5 million from CHF 272.4 million as of the prior year. The Company’s cash balance provides enough capital resources to progress through at least Q1 2024 without potential incoming milestone payments.
Contract Revenues: Contract revenues for the year ended December 31, 2020 totaled CHF 15.4 million compared to CHF 110.5 million in 2019, representing a CHF 95 million decrease. The Company recognized a CHF 10 million milestone and CHF 4.3 million for research and development activities in 2020 from its Lilly agreement compared to CHF 103.1 million for an upfront payment and milestone and CHF 2.6 million for research and development activities in 2019.
R&D Expenditures: R&D expenses increased by CHF 9.1 million for the year ended December 31, 2020.
Discovery and preclinical expenses: The Company increased expenditures across a variety of its discovery and preclinical programs. These include investments to advance the second generation of our ACI-24 for Down Syndrome project, the initiation of IND-enabling studies of our anti-TDP-43 antibody project and various other investments across our alpha-synuclein and neuroinflammation programs.
Clinical expenses: The Company also increased expenditures across multiple Clinical programs. These include investments to prepare a follow-on trial for our Abeta vaccine for Down Syndrome project, additional enrollment costs for the Phase 1b/2a study for ACI-35.030 and a full year of clinical activities to complete the Phase 1 of our Morphomer Tau asset in partnership with Lilly.
Salary- and benefit-related costs: The Company’s salary- and benefit-related costs increased by CHF 2.7 million, primarily due to the addition of 13 FTEs, annualization of 2019 hires and increases in share-based compensation.
G&A Expenditures: For the year ended December 31, 2020, G&A increased by CHF 2.5 million to 18.6 million. Of this increase, CHF 1.7 million is due to salary- and benefit-related costs, primarily due to the addition of 3 FTEs, annualization of 2019 hires and increases in share-based compensation. Additionally, the Company incurred a CHF 0.8 million increase in other G&A expenses, predominantly associated with depreciation expense, insurance and professional fees
IFRS Income/(Loss) for the Period: The Company reported a net loss after taxes of CHF 61.9 million for the year ended December 31, 2020, compared with net income of CHF 45.4 million for 2019
2021 Financial Guidance

For the full year 2021, the Company expects its total cash burn to range between CHF 65 million ‒75 million.

On March 23, 2021 PhoreMost Ltd., the UK-based biopharmaceutical company dedicated to ‘Drugging the Undruggable’ disease targets, reported it has completed an oversubscribed £33m ($46m) Series B investment round (Press release, PhoreMost, MAR 23, 2021, View Source [SID1234577046]). The round was led by BGF, the UK’s most active growth economy investor, and included new investors XtalPi Inc., Astellas Venture Management, Trend Investment Group, and o2h ventures. Existing investors Parkwalk Advisors, Morningside Ventures, and Jonathan Milner also contributed.
The funding will be used to progress PhoreMost’s preclinical ‘Allosteric PLK1’ collaboration with Sentinel Oncology into the clinic in 2022. The programme is initially targeted towards Glioma. PhoreMost will also progress multiple additional internal first-in-class drug discovery programmes across both oncology and ageing therapeutic indications.

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PhoreMost’s SITESEEKER platform can identify the best new therapeutic targets for any chosen disease setting, and rapidly identify how to develop novel drugs to these targets. This has the potential to significantly increase the diversity of novel treatments for cancer and other unmet diseases. Significantly, PhoreMost has recently deployed SITESEEKER towards the identification of novel E3-ligands, the progression of which has the potential to be highly disruptive within the important new targeted protein degradation therapeutic modality space.

Following the investment round, Dr Catherine Beech will assume the Chair of PhoreMost’s Board of Directors, succeeding Dr Jonathan Milner who will stay on the Board as an NED. Catherine joined PhoreMost as Non-Executive Director in February 2020. Also joining the Board are Tim Rea, investor at BGF, Alan Jiang, Chief Strategy Officer of XtalPi, and Neil Pegg representing Morningside Ventures.

PhoreMost raised £11M ($15M) in a series A round in 2018, after which the Company expanded its SITESEEKER capabilities in both target discovery and drug discovery.

Dr Chris Torrance CEO, PhoreMost, commented: "We are thrilled to include this exceptional group of investors in PhoreMost’s Series B funding round. We are grateful for the continued support of existing investors and are delighted to welcome BGF, alongside strategic investors XtalPi with whom we have a highly valued ongoing research collaboration, and Astellas Venture Management.

PhoreMost is at an incredibly exciting phase of development, having made tremendous progress since the Series A funding. Our lead ‘Allosteric PLK1’ asset is well positioned for clinical entry and our SITESEEKER platform has made valuable discoveries within the targeted protein degradation, oncology and ageing fields. This funding now positions PhoreMost well to prosecute asset development across these high value therapeutic areas.

I would like to thank the PhoreMost team and all of our partner organisations for helping us to achieve such excellent progress toward realising our important mission. I also welcome Catherine Beech to the PhoreMost Chair and thank our outgoing Chair Jonathan Milner for his exceptional stewardship over the past five years."

Tim Rea, investor, BGF, said: "The team at BGF has been actively engaged in expanding our support for life sciences companies in the UK and we are excited to join the PhoreMost team on the next phase of their journey. The Company’s SITESEEKER technology is highly differentiated, addressing an important market need in the identification of novel drug sites within targets previously considered undruggable. We have been consistently impressed with the strong and experienced management team, and we believe PhoreMost is now in an ideal position to capitalise on the potential of its lead asset and innovative pipeline."

Dr Catherine Beech, Chair, PhoreMost, said: "Since joining PhoreMost’s Board I have continued to be impressed by the progress the Company has made, both in terms of its own internal programmes as well as with a range of strategic collaborations. I am honoured to be appointed as Chair and look forward to working even more closely with Chris and the team during this exciting time for PhoreMost."

Dr Alan Jiang, CSO of XtalPi, said: "XtalPi and PhoreMost share the same goal of addressing bottleneck challenges in biopharmaceutical research with innovative technologies. We are excited to support PhoreMost in fulfilling its mission and further strengthen the collaboration between our platforms with complementary capabilities. PhoreMost’s expertise in identifying and validating valuable novel targets, combined with XtalPi’s advantage in using AI to discover and design drug molecules for challenging biding sites, will allow us to generate pipeline assets more efficiently, particularly in underserved therapeutic areas, to the ultimate benefit of patients with few or no treatment options."

Alastair Kilgour, Chief Investment Officer, Parkwalk Advisors, said: "PhoreMost’s technology has the potential to significantly increase the diversity of novel therapeutics for cancer and other unmet diseases, where treatment options are currently severely limited, and therefore improve the lives of millions suffering with untreated conditions. Since our original investment we have been impressed by the whole PhoreMost team, who have gone from strength to strength. It made perfect sense for us to follow on that original investment and help them accelerate, grow, and continue to meet this important challenge."

On March 23, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported that its Board of Directors has initiated a process to carry out a fully secured rights issue of units, consisting of new shares and warrants with pre-emptive subscription rights for the Company’s existing shareholders (the "Rights Issue") (Press release, Allarity Therapeutics, MAR 23, 2021, View Source [SID1234577064]). Upon full subscription in the Rights Issue, the Company will initially receive gross proceeds of approximately SEK 100 million. In the event that all warrants are exercised, the Company will receive additional gross proceeds of approximately SEK 200 million. The proceeds from the Rights Issue will strengthen the Company’s financial position and enable it to continue executing its strategy focused on the Company’s three high-priority programs. The Board of Directors also announces that it intends to convene the Annual General Meeting on 15 April 2021 in order to secure shareholder approval of the necessary authorizations to the Board of Directors for the proposed Rights Issue. Notice of the Annual General Meeting will be published through a separate press release.

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Summary of the proposed Rights Issue

The Rights Issue is subject to and will require shareholder approval to authorize the Board of Directors to resolve and implement the necessary changes to the Company’s Articles of Association, including the necessary authorizations to increase the share capital.
The Company has obtained a combination of subscription undertakings and guarantee commitments amounting to in aggregate approximately SEK 101 million, corresponding to approximately 100 percent of the Rights Issue, including undertakings from the Company’s largest shareholder.
Provided that the shareholders approve the necessary authorizations, the Board of Directors intends to resolve and finally approve the Rights Issue on or around 16 April 2021.
The proceeds from the Rights Issue will strengthen the Company’s financial position and enable it to continue executing its strategy focused on the Company’s three high-priority programs.
Each share held in the Company on the record date 7 May 2021 will entitle the shareholder to subscription of one (1) Unit Right. Two (2) Unit Rights confers the right to subscribe one (1) Unit.
One (1) Unit consists of one (1) newly issued share and one (1) warrant (series TO 3) in the Company. The Rights Issue consists of a maximum of 119,520,759 Units.
The subscription price per Unit is SEK 0.85.
Each warrant issued in the Rights Issue is intended to confer the right to subscribe for one (1) share against cash payment of SEK 1.70. The warrants may be exercised in a period of up to 24 months following the Rights Issue.
Proceeds from the Rights Issue will be approximately SEK 100 million before costs. The costs are estimated to approximately SEK 6 million excluding fees to underwriters. The underwriters’ fees are estimated to be approximately SEK 10 million. All fees will be paid in Units.
If all warrants issued in connection with the Rights Issue are exercised, the Company will receive an additional amount of approximately SEK 200 million.
Allarity’s CEO, Steve Carchedi, stated, "Allarity is now at a stage where we are fully focused on delivering clinical and commercial progress of our three high-priority projects, and the potential value inflection points for all of these projects may soon start to appear on our horizon, within this year and the next. This situation creates the right moment for our Company to present a highly competitive investment case to both our current and new shareholders."

Leon Sass, CEO of Sass & Larsen ApS, the Company’s largest shareholder, noted, "I am pleased to observe the progress the Company has made since the end of 2019, including the work toward possible COVID-19 treatment. Based on this performance, I am excited about the future and continuing to support the Company on its path to revolutionize cancer treatments for the benefit of patients across the world."

Background and reasons for the proposed Rights Issue

Allarity Therapeutics is a leading clinical-stage cancer therapeutics company realizing the promise of personalized cancer care by advancing three priority drug programs, dovitinib, stenoparib, and IXEMPRA together with their DRP companion diagnostics.

The Company expects to file its first New Drug Application (NDA) for dovitinib with the U.S. FDA within 2021, thereby initiating the final phase of preparations before a potential U.S. market approval. The company has previously received feedback from a pre-NDA meeting with the FDA, regarding possible approval for dovitinib used to treat renal cell carcinoma (RCC). In parallel, the Company is working on submitting a Pre-Market Approval (PMA) application with the U.S. FDA for use of the DRP companion diagnostic for dovitinib. FDA approval of this NDA and PMA would be the first time a DRP + drug combination has reached the cancer market, and would be a milestone for event for the Company and its DRP platform technology. Allarity holds global, exclusive rights to dovitinib.

Secondly, the Company is currently conducting a DRP-guided Phase 2 clinical trial to evaluate IXEMPRA for the treatment of third-line metastatic breast cancer. The Company’s protocol plans for an enrollment target of 60 IXEMPRA DRP-selected patients. Numerous trial sites are planned in Europe, including Belgium, England, Denmark, Finland, Poland and Germany. By using DRP for patient selection, Allarity aims to provide a superior clinical benefit to patients receiving IXEMPRA, as compared to historical clinical data from breast cancer patients treated with IXEMPRA but not selected with DRP. Allarity holds exclusive European option rights to IXEMPRA, which is already approved by the FDA for the treatment of metastatic breast cancer and is currently marketed by R-PHARM U.S.

Thirdly, the Company is currently advancing a Phase 2 trial of stenoparib for the treatment of advanced ovarian cancer at the Dana-Farber Cancer Institute (Boston, MA U.S.A.) using a DRP companion diagnostic to guide patient enrollment and improve therapeutic outcome. In addition, stenoparib has shown in vitro anti-viral activity against Coronavirus in pre-clinical studies and is now further being pre-clinical tested for its anti-viral properties against the British and South African variants of Coronavirus.

Oncology drug development requires capital, and the Company operates within a range of scenarios of how the Company may be funding its journey towards commercialization in the years ahead, beyond the capitalization plans published in this announcement. Such options include commercial partnering possibilities, listing on an exchange in the US, as many of the Company’s peers are listed on Nasdaq in the US, and on an ongoing basis applying for non-dilutive government funding.

That being said, given the advanced stage of all three high-priority programs, the Company has now reached a stage in its evolution where a significant capital raise is prudent.

Use of Issue Proceeds

The Rights Issue is expected to provide a substantial improvement in the Company’s financial position and to enable the further advancement of its three high-priority programs: IXEMPRA, dovitinib, and stenoparib, by rendering proceeds of approximately SEK 100 million before transaction costs.

Given the Company’s planned roadmap, it expects the net proceeds from the Rights Issue, together with existing liquidity and estimated future cash flows, to be sufficient to fund the Company until 1 February 2022 or possibly longer.

The estimation is based on assumptions about future costs of filing expenses of a New Drug Application and of maintaining two Phase 2 clinical trials in accordance with the Company’s expectations. Deviations from said assumptions with regards to cost levels and timing could have an effect on the Company’s financial position, including the runway the Rights Issue will provide for the company.

In the event that all warrants of this new series TO 3 are exercised for subscription of shares, the Company will receive additional issue proceeds of a maximum of approximately SEK 200 million before issue costs. The additional net proceeds from warrant series TO 3 are intended to be used to further strengthen the Company’s priority programs as noted in Use of Issue Proceeds above.

The Company will discontinue the use of convertible notes as a source of financing of its operations. The Company will meet its short-term financial obligations, until the Rights Issue has been completed, by utilizing a bridge-loan financing facility of SEK 25 million from investors participating in the underwriting consortium, which will be repaid with proceeds from the Rights Issue.

Terms and additional information about the Rights Issue

According to the proposed terms, the right to subscribe for Units with pre-emptive rights shall vest with those who on the record date of 7 May 2021 are registered as shareholders in the Company, whereby holding one (1) existing share in the Company entitles the shareholder to one (1) Unit Right. Two Unit Rights will entitle to subscription of one (1) Unit. One (1) Unit consists of one (1) newly issued share and one (1) warrant (series TO 3) in the Company.

The Units are issued at a subscription price of SEK 0.85 per Unit. In total, a maximum of 119,520,759 Units will be issued through the Rights Issue, corresponding to an amount of approximately SEK 100 million before transaction costs related to the Rights Issue.

The subscription period is expected to commence on 11 May 2021 and end on 21 May 2021, with a right for the Board of Directors to prolong the subscription period.

Subscription for Units without subscription rights will take place during the same time period, and in the event not all Units are subscribed for by use of subscription rights in accordance with the above, the Board of Directors shall, within the limit of the maximum amount of the Rights Issue, decide on allotment of Units subscribed for without subscription rights. First, such allotment shall be made to those who have subscribed for Units with subscription rights, regardless of whether they were shareholders on the record date or not, pro rata in relation to the number of Units subscribed for through exercise of subscription rights and, insofar this cannot be done, by drawing lots. Secondly, allotment shall be made to those who have subscribed for Units without subscription rights, pro rata in relation to the number of Units subscribed for and, insofar this cannot be done, by drawing lots. Thirdly, allotment shall be made to those who have entered into so-called top guarantee undertakings, in relation to such guarantee undertakings. Fourthly, allotment shall be made to those who have entered into so-called bottom guarantee undertakings, in relation to such guarantee undertakings.

Trading in Unit Rights is expected to take place on Nasdaq First North Growth Market from and including 11 May 2021 to and including 21 May 2021, provided that the necessary authorizations to the Board of Directors are adopted by the general meeting and an EU growth prospectus is approved by the Danish Financial Supervisory Authority.

Complete terms and conditions for the Rights Issue, information about the subscription undertakings and guarantee commitments and other information about the Company will be provided in the EU growth prospectus to be released before the commencement of the subscription period.

Preliminary timetable for the Rights Issue

15 April 2021: Annual General Meeting.
4 May 2021: Publication of the EU growth prospectus.
5 May 2021: Last day of trading in the share, including the right to receive subscription rights.
6 May 2021: First day of trading in the share, excluding the right to receive subscription rights.
7 May 2021: Record date for participation in the Rights Issue, i.e. holders of shares who are registered in the share register maintained by Euroclear Sweden AB on this date will receive subscription rights for participation in the Rights Issue with preferential right.
11 May – 21 May 2021: Trading in subscription rights.
11 May – 25 May 2021: Subscription period.
26 May 2021: Expected day for publication of the outcome of the Rights
Subscription undertakings and guarantee commitments

The Rights Issue is fully covered by subscription undertakings and guarantee commitments by the largest shareholder and external underwriters, representing 100% percent of the Rights Issue.

The subscription and guarantee commitments are not secured through bank guarantees, restricted funds, pledged assets or similar arrangements. Consequently, there is a risk that one or more parties will not fulfil their respective commitments.

Shares and dilution

Through the Rights Issue, and payments in Units related to issue costs and fees to Underwriters, the Company’s share capital will increase by up to a maximum of DKK 5,976,037.95 to DKK 17,928,113.90. Existing shareholders that do not participate in the Rights Issue will be diluted by a maximum of 37.52% but will have the possibility to gain economic compensation for the dilution effect by selling their subscription rights.

In the event that the Rights Issue and the warrants series TO 3 are both exercised in full, the share capital of the Company will increase from DKK 11,952,075.95 to DKK 23,904,151.85 and the total number of shares will increase from 239,041,519 shares to 478,083,037 shares. The dilution effect will amount to a maximum of 54.56%.

General meeting

The Annual General Meeting (AGM) to be held on 15 April 2021 determine whether shareholders approve of the Board of Directors’ resolution on the Rights Issue and issue of warrants series TO 3 as stated above. The Board of Directors has also resolved to propose amendments to the Company’s Articles of Association regarding changing the limits on the number of shares and share capital in order to enable the Rights Issue.

Advisors

Aalto Capital AB is the sole global coordinator and bookrunner in connection with the Rights Issue and Hagberg & Aneborn Fondkommission AB the issuing agent. Mazanti-Andersen Advokatpartnerselskab is legal advisor to the Company.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug specific DRP to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP is based on messenger RNA from the patient’s biopsies. DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.

On March 23, 2021 CorMedix Inc. (NASDAQ: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that it will report its financial results for the fourth quarter and year ended December 31, 2020, after the market close on Tuesday, March 30, and will host a corporate update conference call at 4:30pm ET (Press release, CorMedix, MAR 23, 2021, View Source [SID1234577011]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Tuesday, March 30TH @ 4:30pm ET
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13715664
Webcast: Webcast Link