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Entry into a Material Definitive Agreement

On July 8, 2021 (the "Amendment Effective Date"), Navidea Biopharmaceuticals, Inc. (the "Company") reported that it entered into an Amendment to Stock Purchase Agreement and Letter of Investment Intent (the "Amendment") with Keystone Capital Partners, LLC ("Investor") pursuant to which Investor agreed to purchase 22,077 shares of Series D Redeemable Convertible Preferred Stock ("Series D Preferred Stock") on or before July 9, 2021 at 5 p.m. Eastern Time for an aggregate purchase price of $2,207,700 (Filing, 8-K, Navidea Biopharmaceuticals, JUL 13, 2021, View Source [SID1234584812]). The Amendment amends that certain Stock Purchase Agreement and Letter of Investment Intent (the "Purchase Agreement") dated August 31, 2020 between the parties, pursuant to which Investor agreed to purchase 150,000 shares of Series D Preferred Stock for an aggregate purchase price of $15,000,000 before the end of the nine-month period following the date when the Company’s registration statement on Form S-1 filed pursuant to the Purchase Agreement was declared effective. Prior to the Amendment Effective Date, Investor had purchased 72,500 shares of Series D Preferred Stock pursuant to the Purchase Agreement, leaving a remaining balance of 77,500 shares of Series D Preferred Stock. After purchasing 22,077 of the remaining shares, Investor has no further right or obligation to purchase shares of Series D Preferred Stock pursuant to the Purchase Agreement. The Amendment also contains a customary mutual release provision.

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Moleculin Receives Approval to Extend Dose Escalation in Phase 1/2 European Clinical Trial Evaluating Annamycin for the Treatment of Acute Myeloid Leukemia

On July 13, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that it has received approval from the Bioethics Committee of the Medical University of Karol Marcinkiewicz in Poznań (Ethics Committee) as well as an allowance from the Polish Department of Registration of Medicinal Products (URPL) for a protocol amendment for its Phase 1/2 evaluating Annamycin for the treatment of subjects with acute myeloid leukemia (AML) that is refractory to or relapsed after induction therapy (Press release, Moleculin, JUL 13, 2021, View Source [SID1234584811]).

Annamycin is the Company’s next-generation anthracycline that has demonstrated a lack of cardiotoxicity in recently conducted human clinical trials for the treatment of AML. Additionally, Annamycin has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin. The Company believes that the use of Annamycin may not face the same usage limitations imposed on doxorubicin. Annamycin is currently in development for the treatment of AML and STS lung metastases.

"Based on the preliminary data seen demonstrating clinical benefit for patients receiving a full course of treatment in the 240 mg/m2 cohort and the recommendation from our medical advisors on the dose limiting toxicity criteria, we are pleased to have Ethics Committee approval and the allowance from the URPL to amend the protocol for future patients. This amendment will allow us to continue dose escalation in the Phase 1 portion of the trial and establish the maximum tolerated dose as we work toward the recommended dose for the Phase 2 portion of the study. Our team is committed to advancing this important clinical program forward and to potentially address the limitations with current treatment options for AML patients," commented Walter Klemp, Chairman and CEO of Moleculin.

The Phase 1/2 AML trial in Poland remains ongoing and is currently dosing patients at 240 mg/m2. Under the previous protocol transient elevated liver enzymes (AST and ALT) observed in two patients were considered a dose limiting toxicity (DLT), which investigators believe would inappropriately limit the potential for continued dose escalation. The amendment to the Annamycin clinical trial protocol allows for a change in the DLT criteria as it relates to transient grade 3 elevations and allows dosing of three additional patients in the 240 mg/m2 cohort. If no DLT (as defined by the new criteria) is experienced with these next three patients, the Company plans to escalate dosing in new cohorts by 30 mg/m2 instead of the 60 mg/m2 previously planned, and with a de-escalation of 15 mg/m2 at the DLT dose if future patients experience a DLT.

The results from the Phase 1 portion of the Company’s U.S. Phase 1/2 clinical trial of Annamycin for the treatment of AML met its primary endpoint and demonstrated a clean safety profile with no evidence of cardiotoxicity when delivered to patients at or below the lifetime maximum anthracycline dose established by the FDA. To date, an independent expert assessment of the absence of cardiotoxicity in the first 19 patients treated with Annamycin in both the Company’s U.S. and European Phase 1 clinical trials in which an independent expert concluded that he "does not see evidence of cardiotoxicity."

Moleculin Biotech expects to continue reporting cohort topline results from the ongoing Phase 1/2 study for treatment of AML and to report the study’s topline results in the second half of 2022. Annamycin has been granted Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML.

Bio-Techne To Host Conference Call On August 5, 2021 To Announce Fourth Quarter 2021 Financial Results

On July 13, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that management will host a conference call and webcast on Thursday, August 5, 2021, at 8:00 a.m. CDT to review fourth quarter 2021 financial results (Press release, Bio-Techne, JUL 13, 2021, https://investors.bio-techne.com/news/detail/259/bio-techne-to-host-conference-call-on-august-5-2021-to-announce-fourth-quarter-2021-financial-results [SID1234584807]).

Access to the discussion may be obtained as follows:

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 3330876.

The replay will be available from 11:00 a.m. CDT on Thursday, August 5, 2021 until 11:00 p.m. CDT on Sunday, September 5, 2021.

Mission Therapeutics to present at Solebury Trout, Venrock and Oppenheimer’s EU Summer Investor Tour

On July 13, 2021 Mission Therapeutics ("Mission"), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), reported that its CEO, Anker Lundemose, will be presenting at the 5th annual EU Investor Tour hosted by Solebury Trout, Venrock, and Oppenheimer on 13-14 July (Press release, Mission Therapeutics, JUL 13, 2021, View Source [SID1234584805]).

Anker will discuss the Company’s business strategy, technology, discovery platform and development programmes in a presentation to investors on Wednesday, 14 July at 10.15am ET / 3.15pm BST. The 30-minute presentation will be followed by a Q&A.

For individuals interested in attending the meeting, please contact the organisers for more information.

Genocea Doses First Patient in Phase 1/2a TiTAN Clinical Trial for GEN-011 Neoantigen-Targeted T cell Therapy

On July 13, 2021 Genocea Biosciences, Inc. (Nasdaq: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported the dosing of the first patient in its TiTAN study, a Phase 1/2a clinical trial testing its GEN-011 therapy. GEN-011 represents a new category of autologous solid tumor cell therapy: neoantigen-targeted peripheral T cells ("NPTs") (Press release, Genocea Biosciences, JUL 13, 2021, View Source [SID1234584804]).

"Dosing the first patient with GEN-011 represents an exciting milestone for Genocea and the field of neoantigen-targeted T cell therapy," said Thomas Davis, M.D., the company’s Chief Medical Officer. "We believe our GEN-011 therapy employs better targeting – using our ATLASTM platform to select optimal neoantigen targets that drive anti-tumor immune responses and avoid immunosuppressive InhibigensTM – and better T cells, derived from easily accessible peripheral blood as opposed to the tumor itself. We are grateful to the patients eager to participate in our trial, to our investigators, and to our colleagues here at Genocea for their great dedication to improve patients’ outcomes. We look forward to reporting top-line results from this study on a subset of patients late in the fourth quarter of 2021 or the first quarter of 2022."

About GEN-011
GEN-011 is a next-generation solid tumor therapy comprised of NPTs CD4+ and CD8+ which are specific for up to 30 antigens to limit tumor escape. NPTs have minimal bystander, non-tumor-specific cells, and are devoid of Inhibigen-specific cells which may be detrimental to clinical response.

About the GEN-011 TiTAN clinical trial
TiTAN is an open-label, multi-center Phase1/2a trial evaluating safety, tolerability, T cell persistence and proliferation and clinical efficacy. The TiTAN clinical trial is testing two dosing regimens, a repeated lower dose regimen of GEN-011 without lymphodepletion and a single high dose administration of GEN-011 after lymphodepletion. Both groups will receive interleukin-2 after GEN-011 dosing to maximize the tumor-killing potential of the infused cells. Initial data from the TiTAN trial is expected in late Q4 2021 or Q1 2022.