Shattuck Labs Announces Closing of Upsized Initial Public Offering and Exercise in Full of the Underwriters’ Option to Purchase Additional Shares

On October 14, 2020 Shattuck Labs, Inc. ("Shattuck"), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of cancer and autoimmune disease, reported the closing of its upsized initial public offering of 13,664,704 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase up to 1,782,352 additional shares of common stock, at a public offering price of $17.00 per share (Press release, Shattuck Labs, OCT 14, 2020, View Source [SID1234568492]). The aggregate gross proceeds to Shattuck from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Shattuck, were approximately $232.3 million. All of the shares in the offering were offered by Shattuck. The shares began trading on The Nasdaq Global Select Market on October 9, 2020 under the ticker symbol "STTK."

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Citigroup, Cowen, and Evercore ISI acted as joint book-running managers for the offering. Needham & Company acted as lead manager for the offering.

The registration statements relating to these securities became effective on October 8, 2020. The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by telephone at (800) 831-9146; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attention: Prospectus Department, by telephone at (833) 297-2926; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Xencor to Present Data from the Phase 1 Study of XmAb®20717 and Three Research Programs at the SITC Annual Meeting

On October 14, 2020 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, reported four poster presentations at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held virtually November 9-14, 2020 (Press release, Xencor, OCT 14, 2020, View Source [SID1234568491]).

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The presentations will include updated results from the ongoing Phase 1 dose-escalation and expansion study of XmAb20717, a PD-1 x CTLA-4 bispecific antibody, in patients with advanced solid tumors. While dose-escalation continues, planned expansion cohorts have enrolled patients with melanoma, non-small cell lung cancer, renal cell carcinoma, prostate cancer, and other cancers without approved checkpoint therapies. New data from three preclinical-stage programs, including the IL-12-Fc cytokine program, the CD28 bispecific antibody platform, and the PD-1 x TGFβR2 bispecific antibody program, will also be presented.

Presentation Details

Abstract 648, "Preliminary safety, pharmacokinetics/pharmacodynamics, and antitumor activity of XmAb20717, a PD-1 x CTLA-4 bispecific antibody, in patients with advanced solid tumors"
Abstract 564, "Potency-reduced and extended half-life IL-12 heterodimeric Fc-fusions exhibit strong anti-tumor activity with potentially improved therapeutic index compared to native IL-12 agents"
Abstract 697, "Tumor-targeted CD28 costimulatory bispecific antibodies enhance T cell activation in solid tumors"
Abstract 714, "PD-1 x TGFβR2 bispecifics selectively block TGFβR2 on PD1-positive T cells, promote T cell activation, and elicit an anti-tumor response in solid tumors"
Posters will be available to registrants of the SITC (Free SITC Whitepaper) Annual Meeting in the Virtual Poster Hall between 9:00 a.m. and 5:00 p.m. ET on each day from November 11-14, 2020. Posters will be archived under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com.

About XmAb20717

XmAb20717 is a bispecific antibody that simultaneously targets immune checkpoint receptors PD-1 and CTLA-4 and is designed to promote tumor-selective T-cell activation. Xencor’s XmAb bispecific Fc domain serves as the scaffold for these two antigen binding domains and confers long circulating half-life, stability and ease of manufacture. XmAb bispecific Fc domains have been engineered to eliminate Fc gamma receptor (FcγR) binding, with the intent to prevent activation and/or depletion of T cells via engagement by FcγR-expressing cells. XmAb20717 is being evaluated in an ongoing Phase 1 study, which is enrolling patients with advanced solid tumors to expansion cohorts and additional dose-escalation cohorts.

Veracyte Announces Two Presentations to Be Shared at CHEST Annual Meeting 2020

On October 14, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported that an oral presentation will be given at the CHEST Annual Meeting 2020 reinforcing the foundational technology behind its noninvasive nasal swab test to identify lung cancer risk in patients with lung nodules (Press release, Veracyte, OCT 14, 2020, View Source [SID1234568490]). The meeting, hosted by the American College of Chest Physicians, is being held virtually October 18-21, 2020.

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"We are on track to introduce our first-of-its-kind noninvasive nasal swab test for early lung cancer diagnosis in the second half of 2021, which we believe is going to transform how lung cancer is evaluated," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "The data being presented at CHEST further confirm our use of ‘field of injury’ technology to detect genomic signals associated with lung cancer – in this case, to distinguish current from former smokers – using patient samples from the nose, compared to the main lung airway. We look forward to unveiling early data regarding our nasal swab test and our expanding lung cancer portfolio at a ‘Research & Development Day’ event before the end of the year."

Lung cancer is the leading cause of cancer deaths, killing nearly 160,000 Americans each year – more than the next three leading cancers combined. Lung nodules are typically the first sign of lung cancer; however, determining which lung nodules are cancerous and which are benign is often challenging, which can lead to unnecessary invasive procedures or delayed treatment.

The CHEST Annual Meeting will also feature early data suggesting the potential to use radiologic data to further augment genomics in the diagnosis of interstitial lung diseases (ILDs), including idiopathic pulmonary fibrosis (IPF), the disease area addressed by Veracyte’s Envisia Genomic Classifier.

The following oral presentation and e-Poster are available to conference registrants as follows:

Title:

Distinguishing current versus former smokers using whole transcriptome RNAseq of bronchial and nasal airway epithelium (oral presentation)

Presenter:

Carla R. Lamb, M.D., Lahey Hospital & Medical Center

Oral Presentation:

Recorded presentation and live Q&A

Timing:

Sunday, Oct. 18, 2020

1:45 p.m.-2:45 p.m. (Central Time)

Title:

Relationship between Envisia Genomic Classifier (EGC) and an HRCT-derived fibrotic index from data-driven texture analysis (DTA) on 50 ILD patients

Presenter:

Stephen M. Humphries, Ph.D., National Jewish Health

e-Poster:

# P0961

Timing:

Available throughout the conference

NOXXON Secures Expanded Capacity and Improved Conversion Conditions for Convertible Bonds From Atlas

On October 14, 2020 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported the amendment of its flexible convertible bond agreement with Atlas Special Opportunities, LLC (ASO), which was disclosed on April 23, 2020, in order to expand its capacity and improve the conversion conditions (Press release, NOXXON, OCT 14, 2020, View Source [SID1234568489]).

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Ten additional tranches of € 475,000 nominal value each have been added to the convertible bond facility which brings the total nominal capacity to € 18.95 million, of which € 16.23 million remain unissued by NOXXON. The conversion price for conversion of outstanding convertible bonds to shares shall now be the 5-day volume weighted average price ("VWAP") of the company’s shares directly preceding the date of conversion. The issuance of the convertible bonds remains at NOXXON’s entire discretion.

"These changes provide additional capacity for financing on an as-needed basis and improve the conditions of conversion. We are pleased to have such support and commitment from Atlas as this vehicle continues to provide a significant level of financial security for NOXXON’s business plans into 2022," said Aram Mangasarian, CEO of NOXXON. "We have been working with external experts on development plans for our ongoing clinical trials in both pancreatic and brain cancer and look forward to communicating them to our shareholders."

NOXXON will draw-down two additional € 475,000 tranches of convertible bonds following the closure of the amended agreement.

The amended characteristics, terms, conditions and dilutive potential of the financing may be found in the Annex to this press release. Further information on the transaction may be found in the April 23, 2020 press release announcing the agreement.

Median Technologies Announces its H1 2020 Results

On October 14, 2020 Median Technologies (Paris:ALMDT), The Imaging Phenomics Company, reported its results for the first half of 2020 (Press release, MEDIAN Technologies, OCT 14, 2020, View Source [SID1234568488]). On October 12, 2020, the Board of Directors of Median Technologies approved the consolidated financial statements for the first six months of 2020.

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Strong revenue growth, accelerated investments and initial promising results for iBiopsy

For the first half of 2020, Median Technologies recorded revenue of €5.9m, an increase of 47.9% compared with the first half of 2019. This figure was entirely attributable to the iCRO business unit1, which provides imaging solutions and services for clinical trials in oncology. The iBiopsy platform is currently in the R&D stage and is not yet generating revenue.

Median increased its investment in the development and validation of its imaging phenomics platform iBiopsy during the first-half 2020. The company also signed its first partnership with the Assistance Publique – Hôpitaux de Paris, AP-HP, structured iBiopsy around three clinical development plans and launched the first phases of clinical validation. During H1, Median announced promising results on a preliminary study to evaluate the risk of tumor recurrence in patients with hepatocellular carcinoma (HCC).

As of June 30, 2020, the iCRO business unit’s order intake worldwide was well ahead of the forecasts issued for the first half period, despite the health crisis caused by the Covid-19 outbreak. At the end of H1 2020, the order backlog2 stood at €53.6m, an exceptional increase of 40% relative to the order backlog as of December 31, 2019. During the first half, order intake included phase III studies sponsored by major pharma companies in Europe, and further strengthened the order backlog. To date, the backlog includes 28 phase III trials, which represents a substantial increase since 2019 and testifies to the relevance of Median’s offering and the quality of its imaging services. Considering this order backlog, Median has total confidence in revenue it stands to generate over the coming quarters.

Summary financial information (consolidated financial statements under IFRS)

The increase in personnel expenses in H1 2020, compared to the same 2019 period, stemmed from new recruitments for the iBiopsy business unit following the release of the first tranche of the European Investment Bank (EIB) loan, as well as the increase in headcount for the iCRO business unit, in line with the sharp growth in order intake. Overall, the company’s average headcount stood at 117 people in H1 2020, up 36% from 86 people in H1 2019. Meanwhile, the rise in external charges was primarily due to the increased use of consulting radiologists (due to the number of trials underway) to provide medical image reading services for the iCRO activity.

As a result of these items, Median recorded an operating loss of €4.5m in H1 2020, compared with a loss of €4.2m in H1 2019. Consolidated net income came to -€4.6 million compared with -€4.2million as of June 30, 2019.

As of June 30, 2020, cash and cash equivalents were €19.4m. This figure includes a received payment of €15m, as part of the first instalment of the €35m loan granted by the EIB. As a reminder, this loan is aimed at accelerating investment in Median’s innovation program for the iBiopsy imaging phenomics platform. Cash and cash equivalents also include a €1.4m Research Tax Credit.

During the first half of 2020, excluding impacts from the first tranche of the EIB loan and the Research Tax Credit, Median spent €4.6m in cash, with a burn rate of €3.7m in the first quarter, dropping to €0.9m in the second quarter

Events after the reporting period and Company outlook

The iCRO business performance indicators for Q3, 2020 will be published on October 20. The iCRO business unit is expected to continue generating positive momentum worldwide. Meanwhile, the development plan for imaging phenomics platform iBiopsy is moving forward in line with expectations. Since closing its H1 2020 accounts, the company has issued initial promising results on the use of the iBiopsy technology in the context of evaluating cancer patient response to immuno-oncology drugs.

"The results obtained are much better than our initial forecast for the first half of this year, and the second quarter of 2020 marked our seventh consecutive quarter of revenue growth," said Fredrik Brag, Median co-founder and CEO. "The business strategy implemented in 2019, focusing on key pharma accounts and strengthening our relationships with existing clients, has yielded huge rewards. Our order intake hit an all-time high for the first six months of the year. We are now entering a period of high transformation of our order backlog in revenues. Meanwhile, we are pushing ahead with our iBiopsy clinical and technological validations, in line with our clinical development plans, starting with small patient cohorts and moving on to larger cohorts. This approach will continue to take shape thanks to clinical partnerships, such as the one signed in March with AP-HP."