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XBiotech Announces Dividend to Holders of Common Stock

On July 6, 2021 XBiotech Inc.’s (NASDAQ: XBIT) ("XBiotech") Board of Directors reported that it has declared an extraordinary cash dividend of approximately $2.50 per share, or up to an aggregate of $75 million, to holders of its common stock (Press release, XBiotech, JUL 6, 2021, View Source [SID1234584616]). This one-time, special dividend will be payable on July 23, 2021 to stockholders of record at the close of business on July 16, 2021.

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"XBiotech’s proven ability to develop highly valued drug candidates, revenue from contract operations, judicious deployment of operating capital, absence of debt, and very significant emerging opportunities in our pipeline, has created the balance sheet flexibility that enables us to provide shareholders this dividend," commented John Simard, chairman and CEO of XBiotech.

The Company cannot guarantee any future dividends. The declaration and payment of future dividends, if any, will be at the sole discretion of the Company’s Board of Directors based on its consideration of various factors, including the Company’s operating results, financial condition and anticipated capital requirements.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

Capital Increase in Genmab as a Result of Employee Warrant Exercise

On July 6, 2021 Genmab A/S (Nasdaq: GMAB) reported that it will increase its share capital by 47,974 shares as a consequence of the exercise of employee warrants (Press release, Genmab, JUL 6, 2021, View Source [SID1234584615]).

The increase is effected without any preemption rights for the existing shareholders of the company or others. The shares are subscribed in cash at the following price per share of nominally DKK 1:

Proceeds to the company are approximately DKK 42.04 million. The increase corresponds to approximately 0.07% of the company’s share capital.

The new shares are ordinary shares without any special rights and are freely transferable negotiable instruments. The new shares give rights to dividends and other rights in relation to the company as of subscription. The new shares will be listed on Nasdaq Copenhagen after registration with the Danish Business Authority. The capital increase is expected to be finalized shortly.

Pursuant to section 32 of the Danish Capital Markets Act No. 1767 of November 27, 2020, it is hereby announced, that the total nominal value of Genmab A/S’ share capital after the capital increase is DKK 65,668,714 which is made up of 65,668,714 shares of a nominal value of DKK 1 each, corresponding to 65,668,714 votes.

Celleron Therapeutics’ CXD101 shows promising clinical results in its China IND programme with partner Nuance Biotech

On July 6, 2021 Celleron Therapeutics, the UK-based company developing novel medicines for cancer patients, reported encouraging early clinical data from its Hong Kong Phase I study to develop CXD101 in patients suffering from peripheral T-cell lymphoma (PTCL), a rare type of blood cancer (Press release, Celleron, JUL 6, 2021, View Source [SID1234584614]).

Previously, a Phase I trial in multiple tumour types conducted in the UK demonstrated that CXD101 has an excellent safety profile. A promising signal for efficacy in multiple tumour types was observed, which led to the grant of EU Orphan Drug Designation in PTCL.

The current Phase I bridging study conducted in Hong Kong is evaluating the safety and pharmacokinetics in Chinese patients with a range of tumour types which have progressed despite multiple previous chemotherapy treatments. Together with the approved Chinese IND application, the current results open the way for the roll out of a Phase II clinical trial commencing late 2021. Preliminary imaging measurements of tumour size indicated that all patients in the first cohort showed a response, with one patient demonstrating a complete clinical response.

Professor David Kerr, Chief Medical Officer of Celleron Therapeutics, commented: "This is an important step forward in the development of CXD101 for Chinese patients. We know that the drug is clinically active in a range of haematological malignancies which are resistant to conventional chemotherapy from earlier studies conducted in the UK. Even at this early stage, the pattern of response appears to be similar in the Hong Kong study. These are important and encouraging results which endorse our Chinese drug development strategy".

Quest Diagnostics To Release Second Quarter 2021 Financial Results On July 22

On July 6, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report second quarter 2021 financial results on Thursday, July 22, 2021, before the market opens (Press release, Quest Diagnostics, JUL 6, 2021, View Source [SID1234584613]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "7895081." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-360-3307 for domestic callers or 203-369-0162 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on July 22, 2021 until midnight Eastern Time on August 5, 2021.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

Sirnaomics Receives FDA Approval of IND for Phase 1 Clinical Trial of Systemic RNAi Therapeutic STP707 for Solid Tumor Treatment

On July 6, 2021 Sirnaomics, Inc., a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that the company’s IND application for a systemic siRNA (small interfering RNA) drug candidate STP707 received the U.S. Food and Drug Administration (FDA) acknowledgment "Study May Proceed", in patients with advanced solid tumors (Press release, Sirnaomics, JUL 6, 2021, View Source [SID1234584612]). This "Phase 1 Multicenter, Open-Label, Dose Escalation Study and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of STP707 Administered Intravenously in Subjects with Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy" is expected to begin enrolling in coming months.

Sirnaomics’ lead product candidate, STP707, is an anti-cancer siRNA (small interfering RNA) therapeutic. It takes advantage of a dual-targeted inhibitory property and a proprietary polypeptide nanoparticle (PNP)-enhanced targeted delivery to solid tumors and metastatic tumors via systemic administration. Initial preclinical study has demonstrated that knocking down TGF-β1 and COX-2 gene expression simultaneously in tumor microenvironment increases active T cell infiltration. A further combination study demonstrated a synergistic antitumor activity between STP707 and PD-L1 antibody using a mouse orthotopic liver cancer model.

"The IND green light from the US FDA for Sirnaomics’ first IV oncology drug, STP 707, represents another major milestone for the company’s mission in discovery and development of novel siRNA therapeutics for unmet clinical needs. Sirnaomics’ drug target selection and tumor targeting delivery should support a high rate of success for novel anticancer siRNA therapeutics, which have been verified in our clinical and preclinical studies" said the Founder and CEO of the company, Dr. Patrick Y. Lu. "Sirnaomics is currently in a strong position to lead the RNAi community in the development of novel oncology therapeutics."

"This IND approval represents a sentinel moment for the company as we can now expand our therapeutic reach in IV administration. This will allow more opportunities to target critical diseases with high unmet clinical need," stated Chief Medical Officer, Michael Molyneaux M.D. "We expect that our rigorous oncology basket clinical study design will enable us to gain great insights into the impact of STP707 on multiple solid tumor types. Our IND enabling non-clinical studies with STP707 demonstrated an excellent safety profile as well as very good efficacy in multiple tumor types."

About STP707

STP707 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively, formulated in nanoparticles with a Histidine-Lysine Co-Polymer (HKP+H) peptide as the carrier. The specific carrier peptide is distinct from the carrier used in Sirnaomics’ STP705 product. Each individual siRNA was demonstrated to inhibit the expression of their target mRNAs, and combining the two siRNA’s produces a synergistic effect that diminishes pro-inflammatory factors. The drug substances in STP707 are two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively. Over-expressions of TGF-β1 and COX-2 have been well-characterized in playing key regulatory roles in tumorigenesis. In preclinical studies with STP707, intravenous (IV) delivery resulted in knock-down of TGF-β1 and COX-2 gene expressions in various organs including liver and lung. In addition, in preclinical models STP707 had antitumor activity in various solid tumor types.