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Laekna Therapeutics Raises $61 Million in Series D financing

On May 18, 2022 Laekna Therapeutics ("Laekna"), a clinical-stage global biotechnology company dedicated to developing next generation medicines to treat cancer and liver diseases, reported that it has raised $61 million in Series D financing led by CS Capital with support from Worldstar, and Infinity Capital (Press release, Laekna Therapeutics, MAY 18, 2022, View Source [SID1234614835]). Yanchuang Capital as the existing investor continued to support the company with additional funding.

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Laekna’s robust infrastructure has enabled the rapid development of 14 innovative drug candidates. The company has initiated six clinical programs, three of which are multi-regional clinical trials (including one pivotal trial) to address urgent, unmet medical needs in the standard of care-resistant cancers.

In the four rounds of financing to date, Laekna has been supported by leading healthcare-focused institutional investment firms. In addition to CS Capital, most recently, SCGC led the company’s $61 Series C financing in October 2020, after GP Healthcare Capital and OrbiMed Healthcare Fund Management led the Series B and Series A financing rounds, respectively.

Proceeds from the Series D financing will be used to accelerate the clinical development of Laekna’s two core product candidates, AKT kinase inhibitor afuresertib (LAE002) and the world’s first clinical-stage CYP17/CYP11B2 dual inhibitor (LAE001). Both product candidates cover three differentiated key mechanisms, namely targeted therapy, hormonal therapy, and immuno-oncology therapy. Laekna’s most advanced clinical trial is an open-label, randomized, multi-regional Phase 2 PROFECTA-II clinical trial of afuresertib, the world’s first registration-directed clinical trial of an AKT kinase inhibitor to treat platinum-resistant ovarian cancer.

"As Laekna celebrates its fifth anniversary in April, I would like to thank our new and existing investors. Over the past five years, it has been our honor to be recognized and supported by all of our partners. I believe that the time has come for Laekna as we work together with like-minded partners towards a better future," said Dr. Chris Lu, Chairman and CEO of Laekna. "We have arrived at a critical stage, and we understand that drug discovery and development is a long and often arduous journey. We remain committed to our vision to cure for a better future."

CS Capital life science investment team said, "The global biopharmaceutical industry is booming and has a myriad of thriving players. We decided to invest in Laekna as its R&D pipeline, innovation capabilities and management team deeply impressed us. We will work together with Laekna to help it become a partner and a leader in the industry to benefit patients worldwide."

Cytovia Therapeutics to Present In Vivo Multiple Myeloma Data of its CD38-Targeting Flex-NK™ Cell Engager at EHA 2022 Congress

On May 18, 2022 Cytovia Therapeutics, LLC ("Cytovia Therapeutics"), a global biotechnology company focused on harnessing the power of natural killer (NK) cells to fight cancer through multispecific antibodies and stem cell engineering, reported that it will be presenting at the the Annual European Hematology Association (EHA) (Free EHA Whitepaper)’s (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress, taking place June 9 – 12, 2022 at the Messe Wien Exhibition and Congress Center in Vienna, Austria, and online (Press release, Cytovia Therapeutics, MAY 18, 2022, View Source [SID1234614834]).

The abstract was released on May 12, 2022. The e-poster presentation will be published on the virtual congress platform on Friday, June 10.

Details of Cytovia’s poster presentation:
Title: NOVEL MULTIFUNCTIONAL TETRAVALENT CD38 NKP46 FLEX-NK ENGAGERS ACTIVELY TARGET AND KILL MULTIPLE MYELOMA CELLS
Session Title: Poster session
Session date and time: Friday, June 10, 2022 – 16:30 – 17:45 CEST
Final Abstract Code: P842
Presenting Author: Jean Christophe Bories
Summary: CYT-338 is a tetravalent IgG1-like multifunctional NK cell engager antibody with a novel FLEX-linker that simultaneously binds CD38-expressing cells and NK cells via the activation receptor NKp46. The in vitro and in vivo activity of CYT-338 was studied in myeloma models. CYT-338 showed specific dose-dependent binding to CD38 expressing MM cells with ~ 2-fold higher mean fluorescence intensity than daratumumab. Epitope mapping studies suggest binding of CYT-338 to a CD38 epitope distinct from daratumumab. CYT-338 showed greater dose dependent NK cell redirected cytolysis, degranulation, and cytokine production against MM1S cells compared to daratumumab. CYT-338 combined with peripheral blood NK cells inhibited tumor growth in a MM1S-NSG mouse model. CYT-338 showed minimal immune subset depletion, NK cell fratricide, and cytokine release compared to daratumumab in human PBMCs in-vitro. These results suggest that the CYT-338 engager has a favorable NK cell engager profile for targeting CD38-expressing multiple myeloma distinct from daratumumab.

Bavarian Nordic – Transactions in Connection with Share Buy-Back Program and Termination of Share Buy-Back Program

On May 18, 2022 Bavarian Nordic A/S (OMX: BAVA) reported that the share buy-back program, which was announced and initiated on May 9, 2022, has now been terminated, as the intended number of shares under the program has been repurchased (Press release, Bavarian Nordic, MAY 18, 2022, View Source [SID1234614823]). The program was executed in accordance with the provisions of Regulation (EU) No. 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse and supplementing Regulation (EU) 2016/1052 of 8 March 2016, which together constitute the Safe Harbour Regulation. The purpose of the program was to meet the Company’s obligations arising from the share-based incentive program for the Board of Directors and Executive Management.

Under the program Bavarian Nordic A/S has bought back 71,562 shares, cf. the table below:

Transaction date Number of shares Average purchase price, DKK Transaction Value, DKK

The details for each transaction made under the share repurchase program have been attached to this announcement.

With the transactions stated above, Bavarian Nordic A/S owns a total of 146,330 own shares, corresponding to 0.21% of the share capital. The total amount of shares in the company is 70,472,935 including treasury shares.

Citius Pharmaceuticals to Present at the H.C. Wainwright Global Investment Conference on May 24, 2022

On May 18, 2022 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, reported that it will present at the H.C. Wainwright Global Investment Conference being held May 23-26, 2022 (Press release, Citius Pharmaceuticals, MAY 18, 2022, https://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-present-at-the-hc-wainwright-global-investment-conference-on-may-24-2022-301549451.html [SID1234614833]). Leonard Mazur, Chairman and CEO of Citius, will discuss the Company’s recent business developments and upcoming milestones.

Interested parties may schedule 1-on-1 meetings with Citius management by registering through the event platform or contacting the Company’s investor relations team.

Ryvu Therapeutics Reports First Quarter 2022 Financial Results and Provides Corporate Update

On May 18, 2022 Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported financial results for the first quarter of 2022 and provided a corporate update (Press release, Ryvu Therapeutics, MAY 18, 2022, View Source [SID1234614832]).

"As we prepare for several important milestones across our clinical-stage programs in 2022, we continue to execute on our mission to develop innovative new medicines that will improve the lives of cancer patients," said Pawel Przewiezlikowski, CEO of Ryvu Therapeutics. "We look forward to presenting preclinical and clinical data on the novel CDK8/19 inhibitor, RVU120, and on SEL24 (MEN1703) at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) and at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. These early-stage clinical readouts will provide Ryvu with valuable, data-driven insights that will help us optimize the clinical development strategy for our lead pipeline assets."

FIRST QUARTER 2021 AND RECENT HIGHLIGHTS

Posters Presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting: Data were presented from the RVU120 Trial-In-Progress in patients with relapsed/refractory metastatic or advanced solid tumor and in vitro and in vivo data demonstrating RVU120 efficacy against hormone-independent breast cancer. Additionally, a novel MTA-cooperative PRMT5 inhibitor as a targeted therapeutic for MTAP deleted cancer was presented.

Appointment of Hendrik Nogai, M.D. as Chief Medical Officer: Dr. Nogai brings 10 years of practice in the treatment of hematological and solid tumor malignancies and 17 years of industry experience in clinical development. Dr. Nogai leads medical, clinical, and regulatory functions to accelerate the development of the company’s pipeline.

Upcoming clinical and corporate milestones

RVU120

· Clinical update from the Phase 1b dose-escalation study of RVU120 in patients with AML or high-risk myelodysplastic syndromes (HR-MDS) and preclinical data describing in vitro and in vivo effects of RVU120 treatment in DNMT3a and NPM1-mutated AML Patient-Derived Cells (PDCs) to be announced as poster presentations at the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) Congress.

· Update from on Phase 1/2 trial of RVU120 in patients with relapsed/refractory (r/r) metastatic or advanced solid tumors to be announced as an abstract book entry at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting: Phase 1/2 clinical trial is an open-label, single-agent study assessing the safety, tolerability and preliminary efficacy of RVU120 in dose-escalation cohorts in patients with r/r metastatic or advanced solid tumors.

SEL24 (MEN1703)

· Program update from Phase 1/2 DIAMOND-01 trial of SEL24 (MEN1703), a first-in-class dual PIM/FLT3 kinase inhibitor, in patients with IDH1/2-mutated acute myeloid leukemia (AML) will be presented at ASCO (Free ASCO Whitepaper) by Ryvu’s partner Menarini Group. Phase 1/2 DIAMOND-01 trial evaluates the single-agent clinical activity of SEL24 (MEN1703) in patients with AML.

· Interim data from the Phase 1/2 study of SEL24 (MEN1703) in patients with IDH1/2-Mutated AML will also be presented by Menarini at the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) Congress.

Synthetic lethality

· Ongoing hit-to-lead optimization of the most advanced program PRMT5 with in vivo POC expected in H2 2022

· Novel targets identification

First Quarter 2022 Financial Update

Cash Position – Cash and cash equivalents totaled $15.5M at the end of the first quarter of 2022, compared to $20.5M at the end of the fourth quarter of 2021.

Operating costs, excluding the non-cash cost of valuation of the Incentive Program ($2M), for the quarter ended March 31, 2022, amounted to $6.2M and related primarily to research and development expenditures, while the operating costs without Incentive Program for the quarter ended March 31, 2021, amounted to $5.8M.

Net Loss Attributable to Common Shareholders – Net loss attributable to common shareholders excluding the non-cash cost of valuation of the Incentive Program was $4.4M for the quarter ended March 31, 2022, as compared to a net loss of $3.6M for the quarter ended March 31, 2021.