On June 22, 2021 Race Oncology Limited ("Race") reported that it has executed an agreement with The Sheba Fund for Health Services and Research, Chaim Sheba Medical Center to commence a Phase 1b/2 trial in relapsed/refractory Acute Myeloid Leukaemia (R/R AML) (Press release, Race Oncology, JUN 22, 2021, View Source [SID1234584209]). This investigator-led trial will be supervised by Professor Arnon Nagler, who was the Principal Investigator on the Phase 2 investigator-initiated trial which reported an impressive 40% response rate as a single agent in R/R AML (ASX Announcement: 16 June 2020).

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This Phase 1b/2 trial will use Bisantrene in a novel three drug combination which in preclinical studies showed superior efficacy in AML cells (ASX Announcement: 10 May 2021). The trial has received human ethics approval and the first patient is expected to be treated in quarter 3 CY 2021.

The trial will run in parallel with a separate Australian Phase 2 trial in patients with extramedullary AML that is expected to begin treating patients in Q4 CY 2021 (ASX Announcement: 2 June 2021).

Both trials form key components of Race’s ‘3 Pillar’ strategy announced at the 2020 AGM (ASX Announcement: 30 November 2020).

Relapsed or Refractory Acute Myeloid Leukemia
Primary refractory or relapsed acute myeloid leukemia is associated with poor prognosis and remains a major therapeutic challenge. Primary refractory AML is defined by the absence of complete remission (CR), manifested by blast count of ≥5% in bone marrow after one or two cycles of intense induction chemotherapy.

Up to 30% of adults with newly diagnosed AML fail to achieve CR after two courses of intensive chemotherapy.

Even when CR is achieved through intense chemotherapy, approximately half of the younger and 80% of the older patients relapse. In both clinical situations, refractory and/or relapsed AML, active disease remains a major therapeutic challenge despite recent advances.

"Relapsed and refractory Acute Myeloid Leukaemia remains a significant challenge for patients and although there have been therapeutic advances in recent years, clinical outcomes are often suboptimal. This trial follows on from the Bisantrene monotherapy study sponsored by the Sheba Medical Centre, which reported promising results last year. In this new trial, we’re using a combination approach as identified by MD Anderson’s Professor Borje Andersson and published recently in the Journal of Clinical and Experimental Oncology. We hope to see that this combination approach will provide synergistic therapeutic benefit and enable patient dosing at lower levels than where either drug is used on its own."

Chaim Sheba Professor Arnon Nagler
Clinical Trial Design
An open-label, Phase 1b/2 study of intravenous FluCloXan ( Fludarabine, Clofarabine, Bisantrene dihydrochloride (Xan)) in cohorts of adult patients with R/R AML using a Simon’s 2-stage design: a Phase 1b lead-in dose escalation stage to establish the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of FluCloXan and a Phase 2 expansion stage to determine efficacy and confirm safety of the FluCloXan regimen at the RP2D in up to 17 subjects.

Phase 1b, Dose-Escalation (Lead-in Stage)
A two-cohort dose escalation schema using a 3 + 3 design will be employed.

Cohort 1 will enroll three subjects to receive the FluCloXan regimen for four consecutive days. If no dose limiting toxicities (DLTs) have occurred in the first three subjects by day 30 of their first cycle of treatment, then dose escalation to Cohort 2 will occur.

Phase 2, Expansion (Efficacy Stage)
Up to 17 subjects will be enrolled into a Phase 2 expansion efficacy cohort using a 2-stage Simon design. Initially, 9 subjects will be enrolled and treated with the recommended dose of FluCloXan regimen determined in Stage 1. If no subject responds according to the response criteria outlined in the European Leukemia Net (ELN) guidelines, in the first 9 subjects, the study will be terminated for futility. If at least one subject shows a response, 8 more subjects will be enrolled and treated. If three or more of subjects treated in Stage 2 respond, the null hypothesis can be rejected.

Efficacy assessments will be based on bone marrow examination at a minimum of two time points on Day 21 and on Day 30. A further bone marrow examination may be performed on Day 42 at the investigator’s discretion, based on the patient’s disease and performance status and/or on peripheral blood hematology results during the treatment course and between Day 21 to 42.

Treatment will be terminated upon any sign of progressive/recurrent disease and/or referral for starting pre-transplant conditioning therapy for (allogeneic) stem cell transplantation.

Subjects who do not progress or experience any dose limiting toxicities may receive a second course of treatment for the same duration as in their first cycle.

All subjects will be actively followed up every three months for a further 12 months following completion of Cycle 1 for disease free survival (DFS) and overall survival (OS).

While the focus of this trial is not aimed at targeting FTO driven cancers, the FTO expression status will be examined for each patient as part of an exploratory trial endpoint.

"We are delighted to be extending our successful collaboration with Prof Nagler and the team at Chaim Sheba using this novel combination approach for relapsed or refractory Acute Myeloid Leukaemia which remains an area of high unmet medical need. This study is an important part of our AML development plan for Bisantrene."

Race CMO Dr David Fuller
Indicative Costs and Timelines
The trial is expected to take 36 to 40 months to complete with full patient recruitment over approximately 18 months. Treatment of the first patient is targeted for Q3 CY 2021, subject to patient recruitment. Given its open-label status, Race expects that data will be reported at interim points throughout the trial.

Race will pay Chaim Sheba a maximum fee of USD $668,739 over the study’s life. Payments will be made to Chaim Sheba throughout the study upon reaching key milestones with the final trial cost dependent on the number of patients recruited and other operational variables.

"This study builds on our Pillar 3 ambitions to see Bisantrene’s historical safety and efficacy in AML demonstrated with superior drug combinations that may benefit patients who remain challenged by initial treatment failures. We hope to see the study confirming Bisantrene’s continued application as a differentiated chemotherapeutic with contemporary clinical relevance."

Race CEO & MD Phillip Lynch
Clinical Trial Summary
Study Title An Open-label, Phase 1b/2, Two-stage, Study of Xantrene (Bisantrene) in combination with Fludarabine and Clofarabine as Salvage Therapy for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
Phase of Development Phase 1b/2
Active Ingredient Bisantrene dihydrochloride, Fludarabine, Clofarabine (FluCloXan)
Study Description Phase 1b/2 study of FluCloXan, in cohorts of adult patients with R/R AML using a 2-stage design: a Phase 1b lead-in dose escalation stage to establish the MTD or RP2D of FluCloXan and a Phase 2 expansion stage to determine efficacy and confirm safety of the FluCloXan regimen at the RP2D.
Principal Investigator Professor Arnon Nagler
Sponsor Race Oncology
Indication/population Adult men and women 18 to 65 years of age with relapsed and/ or refractory Acute Myeloid Leukemia (R/R AML) without central nervous extramedullary disease.
Number of Subjects Phase 1b: up to 12 patients in the dose determining phase
Phase 2: up to 17 patients in the expansion phase
Study Period 36 – 40 months
Study Design A two-cohort dose escalation schema using a standard 3 + 3 design will be employed followed by an expansion phase at the RP2D. As the patient population is considered relapsed and/or refractory to existing treatments, a comparator arm will not be used.
Statistical methods Simon 2 stage
End Points Primary
Phase 1b Dose Escalation: number of subjects experiencing a DLT in each cohort Phase 2 Expansion: Overall Response Rate (ORR) defined as the proportion of subjects with CR and CRi between Day 30 to Day 42 Secondary: Transplant/allo-HSCT rates (for transplant/allo-HSCT-eligible subjects); Combined CR and CRi and PR response rate; Morphologic leukemia-free state (MLFS); Partial remission (PR); Stable disease (SD); Progressive disease (PD); Relapse; Disease free survival (DFS); Overall survival (OS); Time to next treatment (for transplant/allo-HSCT-ineligible subjects); Molecular mutations including FTO overexpression status
Participating Centres 1 – Chaim Sheba Medical Center, Tel Hashomer, Israel
Start Date First patient in: Q3 CY2021
End Date Last patient In (anticipated): Q3 CY2023
Q&A
Will this trial support orphan drug registration of Bisantrene under the FDA 505(b)(2) pathway?
No. This trial uses an optimised drug combination discovered by the MD Anderson Cancer Center under a preclinical research project sponsored by Race Oncology. While this trial will not be used for FDA registration of Bisantrene, it will potentially provide oncologists with data on an optimal drug combination to use in the clinic.

Does this trial target FTO in AML patients?
No. While the trial is not FTO directed, the FTO expression status of the patients cancers in the trial will be determined to see if response correlates with FTO expression levels.

When can shareholders expect progress updates on the trial?
Q3 2021. The trial has received human ethics approval and Trialog has drug ready to supply in Israel. Prof Nagler’s team is highly skilled in treating AML and has recent experience using Bisantrene in AML patients. It is Race’s expectation that the first patient should be treated in the near future subject to recruitment. The Company will be updating our shareholders on progress at key points in the trial.

Why is this trial being run in Israel and not Australia or the USA?
AML has become a very competitive area to recruit patients as many companies are pursuing development of new drugs and treatments for R/R AML. It would not be possible to recruit patients for this combination treatment in Australia before 2024/25 because of competing trials. Prof Nagler’s personal experience using Bisantrene provides Race with a unique opportunity to run this trial now.

Will this trial be treating patients with extramedullary AML?
Yes. While the recently announced Australian AML trial will be exclusive to extramedullary AML patients, this trial will be open to all R/R AML patients including those with the extramedullary form of the disease. The only exception is those with CNS involvement as Bisantrene is not currently thought to cross into the brain and so would be likely be unsuitable for this patient population.

On June 22, 2021 ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ("GSK"), with Pfizer Inc. and Shionogi Limited as shareholders, and Halozyme Therapeutics, Inc. (Nasdaq: HALO) reported a global collaboration and license agreement that gives exclusive access to Halozyme’s ENHANZE drug delivery technology, recombinant human hyaluronidase PH20 enzyme (rHuPH20), for specific targets used in the treatment and prevention of HIV (Press release, Halozyme, JUN 22, 2021, View Source [SID1234584205]).

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Under the terms of the agreement, ViiV Healthcare will make an upfront payment of $40 million to Halozyme for the exclusive license to four HIV small and large molecule targets and is obligated to make potential future payments of up to $175 million in development and commercial milestones per target, subject to achievement of specified development and commercial milestones, including certain specified sales milestones. Halozyme will also be entitled to receive mid-single digit royalties on sales of commercialised medicines using the technology.

The PH20 enzyme breaks down a substance called hyaluronan (HA) that is found in the body’s subcutaneous space (under the skin) that acts as a barrier to the flow of fluid. By breaking down HA locally at the injection site and temporarily removing that barrier, large amounts of fluid can be injected into the subcutaneous space and dispersed. This facilitates the rapid delivery of large volume fluids by subcutaneous injection, potentially reducing the treatment burden of injectable drugs and providing optimised treatment options to patients. The HA is restored under the skin via normal processes within 24-48 hours.

Halozyme’s technology provides ViiV Healthcare with more opportunities to develop ultra-long acting medicines (dosing intervals of three months or longer) with its long-acting portfolio and pipeline products. Plans are underway to initiate the first experiments with the technology by the end of 2021 for investigational, long-acting cabotegravir for prevention of HIV, which is currently administered every two months.

"Many people living with HIV and those vulnerable to HIV tell us that for a variety of reasons, taking medicine every day is a challenge, and we have listened to them," said Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare. "We believe long-acting medicines are the future of HIV therapies and will help address these unmet needs. Our collaboration with Halozyme will keep us at the forefront of developing additional, innovative new options for HIV treatment and prevention as we work towards reducing the burden of HIV treatment."

"We are excited to partner with ViiV Healthcare to create new delivery options for innovative medicines for HIV," said Helen Torley, M.B. Ch. B., M.R.C.P., president and chief executive officer, Halozyme. "This collaboration demonstrates the potential value of our technology to facilitate rapid, large volume subcutaneous injections of not only more traditional medicines but also long-acting injectables, including small molecules, which in turn may further extend dosing intervals for people taking medicines for the treatment and prevention of HIV."

The license gives ViiV exclusive use of Halozyme’s proprietary rHuPH20 technology for four, specific HIV medicine targets that will expand opportunities for development of nearly all of ViiV’s pipeline assets. These assets are integrase inhibitors, reverse transcriptase inhibitors limited to nucleoside reverse transcriptase inhibitors (NRTI) and nucleoside reverse transcriptase translocation inhibitors (NRTTIs), capsid inhibitors and broadly neutralising monoclonal antibodies (bNAbs), that bind to the gp120 CD4 binding site.

Halozyme has licensed its technology to 11 pharmaceutical and biotechnology companies, for potential use in oncology, autoimmune disease, rare disease and infectious disease with products currently approved in oncology and immune deficiency indications. In addition, Halozyme currently has a Cooperative Research and Development Agreement with the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center in the US, which includes a bNAb, N6LS, that ViiV Healthcare licensed from the National Institutes of Health in 2019.

On June 22, 2021 AstraZeneca and MSD reported that its Koselugo (selumetinib) has been granted conditional approval in the European Union (EU) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged three years and above (Press release, AstraZeneca, JUN 22, 2021, View Source [SID1234584201]).

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NF1 is a debilitating genetic condition affecting one in 3,000 individuals worldwide.1,2 In 30-50% of people with NF1, tumours develop on the nerve sheaths (plexiform neurofibromas) and can cause clinical issues such as disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment and bladder or bowel dysfunction.3-7

The approval by the European Commission was based on positive results from the SPRINT Stratum 1 Phase II trial sponsored by the National Institute of Health’s National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP). This trial showed Koselugo reduced the size of inoperable tumours in children, reducing pain and improving quality of life.7,8 This is the first approval of a medicine for NF1 PN in the EU and follows the positive recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency in April 2021. Safety and efficacy data from the SPRINT Phase II trial with longer follow up will be provided as one of the conditions of approval.

Brigitte C. Widemann, MD, Principal Investigator of the SPRINT trial and Chief, NCI Pediatric Oncology Branch, said: "For children with neurofibromatosis type 1, plexiform neurofibromas can grow and develop so significantly that, in some cases, it becomes debilitating. In the SPRINT trial, selumetinib shrank NF1-associated PNs in 66% of patients and showed clinically meaningful improvements in PN-related symptoms."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "As the first medicine approved in the EU for patients with neurofibromatosis type 1, Koselugo has the potential to transform the way plexiform neurofibromas are managed and treated. The SPRINT data showed that Koselugo not only shrank tumours in some children, but also reduced pain and improved their quality of life. This significant milestone was made possible thanks to our research partners, the National Cancer Institute, the Neurofibromatosis Therapeutic Acceleration Program, the Children’s Tumor Foundation, the patient community and every child, parent and doctor involved in the clinical trial."

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: "Before this approval, surgery was the only treatment option for children in the EU with neurofibromatosis type 1 plexiform neurofibromas. This approval marks a significant step forward in addressing the debilitating impact of these tumours."

The SPRINT Stratum 1 Phase II trial showed Koselugo demonstrated an objective response rate (ORR) of 66% (33 of 50 patients, confirmed partial response) in paediatric patients with NF1 PN when treated with Koselugo as twice-daily oral monotherapy.8 ORR is defined as the percentage of patients with confirmed complete (disappearance of PN) or partial response (at least 20% reduction in tumour volume).8 Results were published in The New England Journal of Medicine.7

Koselugo is approved in the US and several other countries for the treatment of paediatric patients with NF1 and symptomatic, inoperable PN. Further regulatory submissions are underway. Clinical trials of Koselugo in adult patients with NF1 PN, including an alternative age-appropriate formulation for paediatric patients, are scheduled to begin this year.

NF1
NF1 is caused by a spontaneous or inherited mutation in the NF1 gene and is associated with many symptoms, including soft lumps on and under the skin (cutaneous neurofibromas) and skin pigmentation (so-called ‘café au lait’ spots). In 30-50% of people, tumours develop on the nerve sheaths.1,3,9,10 These PN can cause clinical issues such as pain, motor dysfunction, airway dysfunction, bladder/bowel dysfunction and disfigurement, as well as having the potential to transform into malignant peripheral nerve sheath tumours.4-7,10 PN begin developing during early childhood, with varying degrees of severity, and can reduce life expectancy by eight to 15 years.3,6,11,12

SPRINT
The SPRINT Stratum 1 Phase II trial was designed to evaluate the objective response rate and impact on patient-reported and functional outcomes in paediatric patients with NF1-related inoperable PNs treated with selumetinib monotherapy.7 This trial sponsored by NCI CTEP was conducted under a Cooperative Research and Development Agreement between NCI and AstraZeneca with additional support from Neurofibromatosis Therapeutic Acceleration Program (NTAP).

Koselugo
Koselugo (selumetinib) is an inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2).8 MEK1/2 proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway. Both MEK and ERK are critical components of the RAS-regulated RAF-MEK-ERK pathway, which is often activated in different types of cancers.13

Koselugo received US FDA Breakthrough Therapy Designation in April 2019, Rare Pediatric Disease Designation in December 2019 and US Orphan Drug Designation in February 2018. Further orphan designations have been granted in the EU, Japan, Russia, Switzerland, South Korea, Taiwan and Australia.

AstraZeneca and MSD strategic oncology collaboration
In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor, and Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On June 21, 2021Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, ("Transgene" or the "Company") reported the launch of a capital increase through the issuance of ordinary shares, with a waiver of preferential subscription rights, via a private placement in the context of an accelerated bookbuilding for an amount of approximately 32 million euros (the "Capital Increase") (Press release, Transgene, JUN 21, 2021, View Source [SID1234621818]).

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The 32-million euros Capital Increase could be increased to approximately 20% of Transgene’s share capital resulting in the issuance of a maximum of 16,768,266 new ordinary shares. The Offering is exclusively directed at certain qualified and institutional investors located in and outside of France. This transaction will benefit from the support of the Company’s historical shareholders. It will extend the Company’s financial visibility until the fourth quarter of 2023.

Funds will be directly used by descending order of strategic priority:
• circa €25m for the finalisation of clinical studies and the obtention of data with TG4001, TG4050, BT-001 and TG6002;
• circa €4m to launch the clinical development of new oncolytic viruses based on the Invir.IO platform and currently undergoing preclinical evaluation;
• for the remainder, to finance, together with operational products of the Company, R&D and operational costs, as well as current cash consumption.

MAIN TERMS OF THE CAPITAL INCREASE The Capital Increase consists of a private placement pursuant to Articles L. 225-136 of the French Commercial Code and L. 411-2 1° of the French Monetary and Financial Code. The transaction will be carried out with a waiver of preferential subscription rights, pursuant to the delegation of authority granted to the Board of Directors under the 22nd resolution of the Combined General Shareholders’ Meeting of May 27, 2020. The offering is reserved in the European Economic Area (including in France), to "qualified investors", as that term is defined in Article 2(e) of Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017 as amended (the "Prospectus Regulation"), in the United States of America to "Qualified Institutional Buyers" in accordance with Rule 144A under the U.S. Securities Act of 1933 (the "Securities Act") and outside the United States of America to "institutional investors", in accordance with Regulation S of the Securities Act.

SHAREHOLDERS’ SUBSCRIPTION AND LOCK-UP AGREEMENTS Institut Mérieux, which currently holds 99.5% through its subsidiary TSGH, 60% of the company’s share capital indicated that they intend to place an order of 25 million euros. Furthermore, SITAM Belgium (previously Dassault Belgique Aviation), which hold 4.9% of the company’s share capital, have indicated that they intend to subscribe for new ordinary shares in the Capital Increase in order to maintain their current level of participation in the Company. The total amount of these two orders represent up to approximately 80% of the Offering. Orders of TSGH and SITAM Belgium will be placed "at any price" in order not to interfere with the pricing of the Capital Increase. The press release announcing the results of the Capital Increase will set out the shareholding resulting from the transaction.

This renewed support is a sign of Transgene’s historical shareholders continued confidence in the Company’s strategy and cutting-edge technologies, against a background of the strong interest shown by clinicians in the Company’s highly innovative drug candidates. Independent board members of the Company were called upon to vote on the transaction, and unanimously approved both the principle of the Capital Increase and its terms. Ms Flory, for TSGH, et Mr Habert, for SITAM Belgique, did not take part to the board meeting. TGSH and SITAM Belgique have agreed with the Global Coordinators for the contemplated transaction that they will not sell or transfer its shares of Transgene for a period ending 90 days after the settlement and delivery of the Capital Increase, subject to the usual exceptions. In connection with the Capital Increase, the Company will enter into a lock-up agreement with the Global Coordinators for a period ending 90 days after the settlement and delivery of the Capital Increase, subject to customary exceptions. The Capital increase is the subject of a placing agreement entered into by the Company and the Global Coordinators on June 21, 2021.

The placing agreement may be terminated by the Global Coordinators at any time up to (and including) the settlement date of the Capital Increase which is expected to take place on June 24, 2021, subject to certain customary conditions. Not for release, publication or distribution, directly or indirectly, in or into the United States of America, Canada, Australia or Japan Page 3/5 C1-Public Natixis INDICATIVE TIMETABLE The private placement will be carried out via an accelerated bookbuilding that will determine the number of ordinary shares to be issued and their subscription price. The accelerated bookbuilding process will begin immediately and should be concluded before the opening of the markets on June 22, 2021, subject to acceleration. Transgene will announce the subscription price as well as the number of ordinary shares to be issued in a further press release at the latest on June 22, 2021 and as soon as practicable after the closure of the bookbuilding process. Settlement of the new ordinary shares to be issued in the context of the Capital Increase as well as their admission of the new shares to trading on Euronext Paris are expected to occur on June 24, 2021. The new shares will bear current dividend rights and will be admitted for trading on the regulated market on Euronext Paris under ISIN code: FR0005175080 – TNG. INFORMATION AVAILABLE TO THE PUBLIC The Capital Increase will not be subject to a prospectus approved by the French Financial Market Authority (the "AMF").

Detailed information on Transgene, including its business, results, prospects and related risk factors are described in the Company’s universal registration document filed with the AMF on April 1st, 2021 under number D.21-0248 (the "Universal Registration Document"), which is available together with other regulated information and all press releases of the Company, on Transgene’s website (www.transgene.fr).

Transgene draws the attention of the public to:
• The risk factors presented in the Universal Registration Document ; the materialization of any or all of these risks is likely to have a detrimental effect on the activity, financial situation, or the results of Transgene or on its ability to achieve its objectives.
• The main risks associated with the Capital Increase are the following: o the market price of the Company shares may fluctuate and fall below the subscription price of the new shares
; o due to stock market fluctuations, the volatility and liquidity of the Company shares may vary significantly; o the sale of Company shares may occur on the secondary market, after the capital increase, and have a negative impact on the Company share price
; o regarding the use of the expected proceeds of the issuance within the context of the Capital Increase, the Company has room for maneuver as to the use of the funds raised and could use them in a way that the shareholders may not adhere to or that would not increase the value of their investment in the short term; and o a new market-based call by the Company, after the Capital Increase, could result in further dilution for the investors.

On June 21, 2021 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported that CEO Robert Cobuzzi, Jr., Ph.D., will present via webcast at the Life Sciences Investor Forum being held on June 24, 2021 (Press release, Diffusion Pharmaceuticals, JUN 21, 2021, View Source [SID1234586811]).

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Details of Diffusion’s presentation are as follows:

Event: Life Sciences Investor Forum
Date: Thursday, June 24, 2021
Time: 11:30 a.m., EDT
Link: View Source
During the presentation, Dr. Cobuzzi will discuss Diffusion Pharmaceuticals’ business strategy, which focuses on developing Trans Sodium Crocetinate to treat a variety of diseases driven by hypoxemia.

Company Highlights:

Completed enrollment and dosing in the TCOM 200-301 study in March 2021
Announced data from the COVID-19 100-303 study in February 2021
Raised $34.5 million in financing in February 2021.
This will be a live presentation. If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event.

About Life Sciences Investor Forum:

Life Sciences Investor Forum is the leading proprietary investor conference series that provides an interactive forum for Life Sciences companies to meet with and present directly to investors.

A real-time solution for investor engagement, Life Sciences Investor Forum is powered by Intrado Digital Media and specifically designed for more efficient investor access. Replicating the look and feel of on-site investor conferences, Life Sciences Investor Forum combines leading-edge conferencing and investor communications capabilities with a comprehensive global investor audience network.