On June 10, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar") and Adgero Biopharmaceuticals Holdings, Inc. ("Adgero") reported the companies have entered into a definitive merger agreement pursuant to which DelMar, a biopharmaceutical company focused on the development of new solid tumor cancer therapies, will acquire Adgero, a privately held biopharmaceutical company focused on the development of its late stage photodynamic therapy platform for the treatment of serious cutaneous oncology indications (Press release, DelMar Pharmaceuticals, JUN 10, 2020, View Source [SID1234560963]). In an all-equity transaction, Adgero stockholders will receive shares of DelMar common stock for shares of Adgero common stock.

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Upon completion of the merger, current DelMar and Adgero stockholders will own 50.5% and 49.5% of the total voting power of the combined company, respectively, exclusive of securities to be issued in a financing to occur prior to the merger closing, as well as compensation payable in connection with the merger and the financing. Subject to stockholder approval of both companies and other closing conditions, the transaction is expected to close in the third quarter of 2020, at which time DelMar is expected to change its name to Kintara Therapeutics, Inc. and trade on Nasdaq under the new ticker symbol "KTRA."

This combination brings together DelMar’s first-in-class, DNA-targeting chemotherapeutic with proven anti-cancer activities with Adgero’s photodynamic therapy platform. The combined company expects to benefit from complementary capabilities along with greater financial resources and flexibility to engage in a wide range of research and development activities that the companies believe will ultimately result in the creation of sustainable long-term growth.

"The acquisition of Adgero by DelMar positions the combined company for long-term corporate growth and increased shareholder value by bringing together DelMar’s oncology therapeutic candidate, VAL-083, and Adgero’s REM-001 photodynamic therapy with a lead indication in CMBC," commented Saiid Zarrabian, President and Chief Executive Officer of DelMar. "This acquisition is the result of an extensive search for a suitable oncology therapy and provides the combined company with a diversified, late-stage oncology pipeline. During the next 12-18 months, we expect to achieve significant clinical milestones, driven by a seasoned leadership team that will bolster our oncology drug development expertise."

Mr. Zarrabian continued, "The clinical data from Adgero’s REM-001 has demonstrated significant anti-tumor efficacy to date, with 80% complete responses reported across four studies in CMBC, and we believe it will be a valuable late-stage pipeline complement to DelMar’s VAL-083 as we prepare for the GBM AGILE registration study."

John Liatos, interim Chief Executive Officer and Chief Financial Officer of Adgero, added, "This combination provides us with the opportunity to not only deepen our pipeline but also strengthen our oncology drug development expertise and capabilities. Furthermore, our enthusiasm to merge with DelMar was reinforced by the Global Coalition for Adaptive Research’s (GCAR) invitation to include VAL-083 in its GBM AGILE pivotal study for the treatment of newly-diagnosed and recurrent GBM. This is an important milestone with the potential to greatly reduce VAL-083’s development timeline and speaks to the potential of VAL-083 given that only a limited number of drug candidates will be invited to participate in the study. On our end, we are tremendously proud of the progress we have accomplished to date, and through this combination we look forward to creating a highly focused oncology company that can develop new therapies to help physicians and patients combat cancers where current treatment options are limited."

Strategic Rationale for the Merger:

Creates a diversified, late-stage oncology company with two Phase 3-ready products that target rare, unmet medical needs in oncology;
Combined robust development efforts to date with an estimated $300 million invested in the development of DelMar’s VAL-083 and Adgero’s REM-001, both of which have demonstrated anti-tumor activity in clinical trials and possess a large patient safety database;
Potential future pipeline expansion opportunities with an existing Orphan designation and an approved IND in ovarian cancer, and existing Orphan designations in basal cell carcinoma nevus syndrome and hemodialysis grafts; and
Bolstered oncology drug development expertise by the combination of DelMar and Adgero leadership is instrumental for the further clinical development of VAL-083 and REM-001.
Anticipated Late-stage Clinical Milestones Over the Next 12-18 Months*:

Report at various oncology meetings, including the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II being held June 22-24, 2020;
Top-line results from VAL-083’s Phase 2 study in newly-diagnosed GBM;
Top-line results from VAL-083’s Phase 2 study conducted at the MD Andersen Cancer Center in recurrent GBM;
Top-line results from VAL-083’s Phase 2 study conducted at the MD Andersen Cancer Center in adjuvant GBM;
Initiation of patient enrollment into the VAL-083 arm of the Global Coalition for Adaptive Research’s GBM AGILE registrational study in newly-diagnosed and recurrent GBM patients; and
REM-001 confirmatory trial results in CMBC
*(subject to financing proceeds available to the combined company)

Organizational Structure

Following the close of the transaction, Saiid Zarrabian, DelMar’s President and Chief Executive Officer, will continue to serve as President and Chief Executive Officer, John Liatos, Adgero’s interim Chief Executive Officer and Chief Financial Officer, will serve as Senior Vice President, Business Development, Scott Praill, DelMar’s Chief Financial Officer, and Dennis Brown, DelMar’s Chief Scientific Officer, will each continue to serve in their respective capacities, and Steve Rychnovsky, Adgero’s Vice President, Operations and Product Development will serve as Vice President, Research and Development.

The combined Company’s Board of Directors will consist of seven directors, four of which will be designated by DelMar, two of which will be nominated by Adgero and approved by DelMar, and the remaining Director will be mutually agreed upon by DelMar and Adgero.

Merger Process Overview and Financial Rationale

Each outstanding share of Adgero common stock will be converted into shares of DelMar common stock at an exchange ratio such that current DelMar and Adgero stockholders will own 50.5% and 49.5% of the total voting power of the combined company, respectively (the "Exchange Ratio"), upon completion of the merger and exclusive of (i) securities to be issued in a financing to occur prior to the merger closing and (ii) compensation payable in connection with the merger and the financing. Each of the 1,470,092 outstanding warrants to purchase Adgero’s common stock will be exchanged for a warrant to purchase DelMar common stock as calculated based on the Exchange Ratio, resulting in a total of 2,299,036 additional DelMar warrants outstanding. Each outstanding Adgero stock option, whether vested or unvested, that has not been exercised will be cancelled for no consideration as it is anticipated that none of the options will be in-the money at the time of the merger.

The transaction has been unanimously approved by the Boards of Directors of DelMar and Adgero. The transaction is subject to customary closing conditions, including, among others, approval by the stockholders of each company, the closing on a minimum $10 million financing, and DelMar’s continued listing on the Nasdaq Capital Market, and is expected to close in third quarter of 2020. Additionally, the transaction has the support from each of the directors and executive officers of DelMar and Adgero.

Lowenstein Sandler LLP acted as external legal counsel to DelMar and Ladenburg Thalmann & Co. Inc. provided a fairness opinion to DelMar. Gracin & Marlow, LLP acted as external legal counsel to Adgero.

On June 10, 2020 Ryvu Therapeutics (WSE: RVU) reported its first quarter 2020 financial results and provided a corporate update (Press release, Ryvu Therapeutics, JUN 10, 2020, View Source [SID1234560981]).

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"Q1 2020 was an exciting and eventful time for Ryvu. We have managed to achieve several important milestones including clinical ones, such as the successful completion of Phase I for SEL24/MEN1703 in acute myeloid leukemia, as well as the receipt of an Orphan Drug Designation for SEL120 for the treatment of AML patients," commented Pawel Przewiezlikowski, Chief Executive Officer of Ryvu.

"We have also secured additional non-dilutive grant financing to support the development of our synthetic lethality program. Together with very good data from our early pipeline projects, it allows us to successfully continue our mission to discover and develop drugs that will improve the lives of cancer patients and their families," adds Przewiezlikowski.

Recent Achievements

On February 26, Ryvu signed a grant agreement for the development of targeted oncology therapies based on the synthetic lethality concept. This grant provides Ryvu with almost $8.3 million of non-dilutive financing to discover, develop and select a clinical candidate targeting cancers which had been considered in the past as largely undruggable using rational approaches. Total net value of the project amounts to $14.0 million and the anticipated project duration is until December 2023.
On March 5, 2020 Menarini Group announced the successful completion of Phase I clinical study of SEL24/MEN1703 in Acute Myeloid Leukemia, which entitled Ryvu to receive a $1.96 million milestone payment. The full data from the study will be presented as a poster "Results of the dose escalation part of DIAMOND trial (CLI24-001): First-in-human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia" during the Virtual 25th EHA (Free EHA Whitepaper) Congress taking place June 11-21.

Throughout the dose escalation part, SEL24/MEN1703 showed an acceptable safety profile up to the recommended dose established at 125 mg/day (14 days ON – 7 days OFF in 21-days cycles). Initial evidence of single agent efficacy was observed with 1 CR and 1 CRi in elderly patients who had exhausted standard therapeutic options. Cohort Expansion study planned in relapsed/refractory AML patients in the United States and Europe including Poland will further investigate the single agent activity and the safety profile of SEL24/MEN1703.
On March 25, 2020 the U.S. Food and Drug Administration (FDA) granted an orphan drug designation (ODD) to Ryvu’s SEL120, for the treatment of patients with acute myeloid leukemia (AML).
Important milestones in 2020, before the report date

On April 16, Galapagos NV (Euronext &NASDAQ: GLPG) and Ryvu Therapeutics S.A. (WSE: RVU) announced a collaboration focused on the discovery and development of novel small molecule drugs in inflammation. The collaboration is based on a novel target identified by Ryvu. Ryvu will contribute its biology and chemistry platform as well as related intellectual property to the program. During the joint research collaboration, Ryvu is responsible for early drug discovery and Galapagos will be responsible for all further development of the program.
On June 2, Ryvu obtained the occupancy permits for its newly built R&D Center for Innovative Drugs, meaning it has completed the construction of the facility. The Company plans to move to the new headquarters by the end of June 2020.
On June 3, NodThera, Ryvu spin-off company, secured £44.5million ($54.5million) Series B financing. NodThera was founded by Epidarex Capital and Ryvu in 2016 based on world class research on NLRP3 inflammasome conducted at Ryvu (at that time Selvita) in 2012 -2016. The company focused on the development of inflammasome inhibitors has already raised over £80.8 million (over $100 million) in three funding series. After the full completion of Series B capital increase, Ryvu will own 4.8% in NodThera.
On June 4, Ryvu signed a grant agreement for the development of targeted immuno-oncology therapy, which provides Ryvu with almost $5.6 million of non-dilutive financing to discover, develop and select a clinical candidate targeting cancers which had been considered in the past as largely undruggable using rational approaches. Total net value of the project amounts to over $8.9 million and the anticipated project duration is until December 2023.
In Q1 2020, Ryvu Therapeutics participated and presented at several investor conferences, including Solebury Trout Investor Access during JP Morgan 2020, Solebury Trout Virtual Investor Conference, BIO-Europe Spring 2020 and 32nd Annual ROTH Conference.

Ryvu First Quarter 2020, Financial Results

In the past quarter, Ryvu Therapeutics noted a 56% increase in its revenues, up to PLN 13.6 million ($3.5 million). Revenues from partnering contracts have increased from PLN 1.1 million ($0.3 million) in Q1 2019, up to PLN 7.8 million ($2.0 million) in Q1 2020.

Operational costs related in majority to the research and development expenditures, remain at a stable level and amounted to PLN 18.6 million ($4.7 million), as compared to PLN 18.4 million ($4.9 million) in same quarter last year. Operational loss has decreased and amounted to PLN 5.0 million ($1.3 million), compared to PLN 9.7 million ($2.6 million) in 1Q 2019.

On June 5, 2020, Ryvu Therapeutics held PLN 48.2 million ($11.6 million) in cash, cash equivalents, and short-term investments.

On June 10, 2020 Lantern Pharma Inc. (the "Company"), a clinical stage biotechnology company, focused on leveraging artificial intelligence ("A.I."), machine learning and genomic data to streamline the drug development process and to identify the patients that will benefit from its targeted oncology therapies, reported the pricing of its initial public offering of 1,750,000 shares of its common stock at a public offering price of $15.00 per share, for gross proceeds of $26,250,000, before deducting underwriting discounts, commissions and offering expenses (Press release, Lantern Pharma, JUN 10, 2020, View Source;utm_medium=rss&utm_campaign=lantern-pharma-announces-pricing-of-initial-public-offering [SID1234561214]). In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 262,500 shares of common stock at the initial public offering price, less the underwriting discount, to cover over-allotments.

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The shares are expected to begin trading on the Nasdaq Capital Market on June 11, 2020 under the ticker symbol "LTRN." The offering is expected to close on June 15, 2020, subject to satisfaction of customary closing conditions.

ThinkEquity, a division of Fordham Financial Management, Inc. is acting as sole book-running manager for the offering. Colliers Securities LLC and Paulson Investment Company, LLC are acting as co-managers for the offering.

A registration statement on Form S-1 (File No. 333-237714) relating to the shares was filed with the Securities and Exchange Commission ("SEC") and became effective on June 10, 2020. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at [email protected].

On June 9, 2020 City of Hope scientists reported that it will showcase research at the AACR (Free AACR Whitepaper) Virtual Annual Meeting II that could one day lead to real-time diagnostic imaging and leading-edge genomic profiling that improve health outcomes for cancer patients, and much more (Press release, City of Hope, JUN 9, 2020, View Source [SID1234560930]).

"Innovative cancer immunotherapy and lifesaving precision medicine are areas City of Hope has doubled down on. In the years to come, we expect to yield research results that could be developed into therapies and practices that transform the delivery of cancer care," said Michael Caligiuri, M.D., president of City of Hope National Medical Center, former American Association for Cancer Research (AACR) (Free AACR Whitepaper) president and the Deana and Steve Campbell Physician-in-Chief Distinguished Chair.

AACR’s second virtual session will take place from June 22-24. More than 61,000 people from 140 countries registered to attend the first virtual session in April. The multidisciplinary meeting program will highlight the best cancer science and medicine in the world.

Using imaging biomarkers to deliver personalized care
Radiomic prediction of survival in recurrent high-grade glioma patients treated with CAR T-cell therapy
City of Hope physician-scientists are developing accurate theranostics (therapy + diagnostics) to deliver precision medicine in cancer care. Ammar Chaudhry, M.D., a diagnostic radiologist at City of Hope, and colleagues used machine learning models to compare the "survival prediction performance" of patients who have a type of brain tumor called high-grade glioma. Having accurate survival prediction performance equips doctors with the data necessary to determine the best treatment options for each patient. Physician-scientists performed baseline imaging, surgically removed the brain cancer and then delivered CAR T cell therapy. Using machine learning, the researchers found that labeling tumor voxels (3D pixels) as non-enhancing tumor (NET) was significantly more accurate at predicting prognosis than using other labeling methods. Further research is needed to make this model more robust.

Precision medicine: Full DNA and RNA genome profiling of all cancer patients
Identifying the genomic correlates of clinical benefit (CB) from immunotherapies (IO) and vascular endothelial growth factor-tyrosine kinase inhibitors (VEGF-TKI) in metastatic renal cell carcinoma (mRCC)
City of Hope is working toward profiling the genomes of all patients to provide the most effective, personalized treatment. Sumanta Pal, M.D., co-director of City of Hope’s Kidney Cancer Program, led a study that looked at tumor-specific alterations resulting from specific cancer treatments. Using a proprietary tool that analyzes all DNA-coding regions, the City of Hope researchers found that having an abundance of mutations at the very end of certain RNA (known as telomeres or TERT promoter mutations) may be a biomarker that predicts immunotherapy will not work for a patient. Understanding how useful certain treatments will be for a specific patient can help physicians weed out ineffective treatments so that time and money can be spent on treatments that have a chance of bringing the patient into remission. Because the sample size was 58 patients, this research warrants further investigation with larger prospective cohorts.

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On June 9, 2020 UbiVac, Inc. (www.ubivac.com) reported it has entered into a clinical trial collaboration with Bristol Myers Squibb (NYSE:BMY) to evaluate the safety, tolerability, and preliminary efficacy of UbiVac’s investigational product, DPV-001, a first-in-class cancer vaccine that exploits autophagy, in combination with Bristol Myers Squibb’s anti-OX40 (BMS-986178) combined with sequenced administration of the programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo (nivolumab) (Press release, UbiVac, JUN 9, 2020, View Source [SID1234560946]). The Phase 1b multicenter trial will test the hypothesis that combination immunotherapy with the DPV-001 cancer vaccine and anti-OX40 will augment anticancer immunity in patients with advanced triple negative breast cancer.

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Triple Negative Breast Cancer is negative for estrogen receptors, progesterone receptors and HER2 receptors, and therefore treatment options are limited. This type of breast cancer tends to metastasize frequently, and occur in younger patients (less than 50 years of age) and those with the inherited BRCA1 mutation.

This is the first clinical trial to combine a cancer vaccine (DPV-001), that educates the immune system to destroy cancer cells, with a T cell agonist, Bristol Myers Squibb’s anti-OX40 (BMS-986178), that amplifies immune system activity. Patients also will receive anti-programmed death 1 immune checkpoint therapy, Bristol Myers Squibb’s Opdivo, which takes the brakes off the immune system.

"UbiVac is thrilled to be working with Bristol Myers Squibb, a world leader in immuno-oncology, to research this innovative cancer vaccine therapy, combined with anti-OX40 and checkpoint blockade, and evaluate whether this treatment boosts anticancer immunity in patients with advanced Triple Negative Breast Cancer," said Bernard A. Fox, PhD., President and CEO of UbiVac and the Harder Family Chair for Cancer Research at the Earle A. Chiles Research Institute and Providence Cancer Institute. The trial will be led by David Page, MD, at Providence Portland Medical Center and enroll patients in Portland and at other centers in the U.S. "I am excited to lead this first-in-human trial, which builds on 25 years of immunotherapy research from the Earle A. Chiles Research Institute," said Dr. Page. "We believe that cutting-edge immunotherapy combinations have the potential to induce long-lasting anticancer immunity and translate into clinical responses in patients with triple negative breast cancer."

About UbiVac’s Innovative Cancer Vaccine Technology

The lead biologic, DRibble Platform Vaccine 001, DPV-001, is a dendritic cell-targeted microvesicle containing short-lived proteins that are thought to represent the dominant HLA-presented epitopes on the surface of cancer cells. These microvesicles are packaged with multiple TLR and NOD agonists, together with 15 DAMPs and chaperones. The microvesicle vaccine also contains more than 100 proteins that are overexpressed by the average triple negative breast cancer and as many as 1700 altered peptide ligands that can augment immunity against cancer antigens. Together this formulation drives B cells, CD4 and CD8 T cells as well as innate components of the host’s immune system to mediate anticancer function.

In preclinical models this vaccine can convert tumors that are considered "cold" because they lack immune cells into tumors that are "hot" with cancer killer cells. This is important as many human tumors are thought to be unresponsive to immunotherapy because they lack immune cells capable of recognizing their cancer and are considered to be "cold" tumors. "Based on these data we believe UbiVac’s DRibble platform vaccine technology combined with anti-OX40 will light a fire in the immune system of patients with cold tumors, turning them into hot tumors that will be more responsive to checkpoint blockade," Hong-Ming Hu, PhD, CSO at UbiVac, said.