On October 20, 2022 Inhibrx, Inc. (Nasdaq: INBX), a clinical-stage biopharmaceutical company dedicated to the development of therapeutics for oncology and rare diseases, reported it will be presenting at multiple upcoming scientific conferences (Press release, Inhibrx, OCT 20, 2022, View Source [SID1234622248]).

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American Conference on Pharmacometrics (ACoP)13th Annual Meeting
October 30th – November 2nd, 2022 – Aurora, Colorado

Title: PK/PD Characterization of INBRX-101, a Novel, Recombinant Alpha-1 Antitrypsin Fusion Protein, in Patients with Alpha-1 Antitrypsin Deficiency
Lead Author: Sharvari Bhagwat
Poster ID: T-009; Abstract ID: PMX436
Poster Presentation on Tuesday, November 1st, 2022 between 8:30 a.m. – 5:30 p.m. Eastern Time

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting
November 8th – 12th, 2022 – Boston, Massachusetts

Title: Development of a Molecular Targeted Cytokine that Specifically Expands Vg9Vd2 T-cells and Potentiates Anti-tumor Activity
Lead Author: Bryan Becklund, PhD
Abstract: 1077
Poster Presentation on Thursday, November 10th, 2022 from 9:00 a.m. – 9:00 p.m. Eastern Time and Friday, November 11th, 2022 from 9:00 a.m. – 8:30 p.m. Eastern Time

Connective Tissue Oncology Society (CTOS) 2022 Annual Meeting
November 16th – 19th, 2022 – Vancouver, BC, Canada

Title: Updated Efficacy and Safety of the Tetravalent Death Receptor 5 Agonist INBRX-109 in Patients with Chondrosarcoma: Data from the Phase 1 Expansion Cohorts
Lead Author: Sant P. Chawla, MD
Abstract: 2206531, Poster (P 043)
Vivek Subbiah, MD to Present Virtual Poster Presentation on Saturday, November 19th, 2022 from 4:36 p.m. – 4:44 p.m. Eastern Time

Title: INBRX-109 in Ewing Sarcoma: Preclinical Rationale for Initiation of a Phase 1 Chemotherapy Combination Expansion Cohort
Lead Author: Nehal J. Lakhani, MD, PhD
Abstract: 2206541, Poster (P 324)
Poster Walk and Reception on Thursday, November 17th, 2022 at 5:00 p.m. – 7:00 p.m. Eastern Time

Title: A Randomized, Placebo-Controlled Phase 2 Trial of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma
Lead Author: Robin Lewis L. Jones, MD
Abstract: 2206600, Poster (P 322)
Poster Walk and Reception on Thursday, November 17th, 2022 at 5:00 p.m. – 7:00 p.m. Eastern Time

The scientific posters will be accessible through a link on the investors’ section of Inhibrx’s website at View Source upon commencement of each respective presentation.

On October 20, 2022 Compass, Inc. (NYSE: COMP), a leading technology-enabled residential real estate brokerage, reported that its third quarter 2022 financial results will be released after market close on Thursday, November 10, 2022 (Press release, Compass Therapeutics, OCT 20, 2022, View Source [SID1234622247]). The company will host a conference call and webcast to discuss its results that afternoon at 5:00 p.m. ET / 2:00 p.m. PT.

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Call details are as follows:

The conference call will be accessible via the Internet on the Compass Investor Relations website, View Source

Please register in advance to access the live conference call: Compass, Inc. 3Q22 Earnings Conference Call.

An audio recording of the conference call will be available for replay shortly after the call’s completion for up to 90 days following the call. To access the replay and shareholder presentation, visit the Events and Presentations section of the Compass Investor Relations website.

On October 20, 2022 Akeso, Inc. (9926. HK) ("Akeso"), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology, reported that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for Ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy for treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR-mutated who failed to prior EGFR-TKI treatment (Press release, Akeso Biopharma, OCT 20, 2022, View Source [SID1234622246]).

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It is Ivonescimab’s second breakthrough therapy designation for lung cancer treatment, and NMPA granted the first one in September 2022 for the first-line treatment of NSCLC patients with positive PD-L1 expression.

Breakthrough Therapy Designation procedure in China is designed to expedite the development and review of innovative drugs with apparent clinical benefits. Chinese regulators will prioritize resources for communication, enhance guidance and facilitate drug development for those drugs included in the procedure of BTD. Drug candidates with BTD can be considered for conditional approval and priority review when submitting a New Drug Application (NDA).

Currently, two Phase III trials of Ivonescimab for major lung cancer indications are ongoing. Receiving the Breakthrough Therapy Designation will accelerate the clinical development and product launch process of Ivonescimab, also further demonstrating the clinical value-oriented drug development concept and innovation capability of Akeso.

About Ivonescimab(PD-1/VEGF, Ak112)

Ivonescimab is a first-in-class and the first to enter phase III clinical trial PD-1/VEGF bi-specific antibody independently developed by Akeso. Engineered with the company’s unique Tetrabody technology, Ivonescimab blocks PD-1 binding to PD-L1 and PD-L2, and blocks VEGF binding to VEGF receptors. PD-1 antibodies combined with VEGF-blocking agents have shown robust efficacy in various tumor types (including renal cell carcinoma, non-small cell lung cancer, and hepatocellular carcinoma). Given the co-expression of VEGF and PD-1 in the tumor microenvironment, Ivonescimab, as a single agent to block these two targets, may block these two pathways more effectively and enhance the antitumor activity, as compared to combination therapy.

Currently, Akeso is conducting a phase III clinical trial of AK112 monotherapy versus Pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression. In addition, a phase III clinical trial of AK112 plus chemotherapy versus chemotherapy in EGFR mutated advanced non-squamous NSCLC that failed in prior EGFR-TKI therapy is ongoing. AK112 has started multiple clinical trials for various stages of treatment of indications, including non-small cell lung cancer and small cell lung cancer.

On October 20, 2022 Biohaven Ltd. (NYSE: BHVN) ("Biohaven") reported the pricing of the public offering of 25,000,000 of its common shares, at a public offering price of $10.50 per common share (Press release, Biohaven Pharmaceutical, OCT 20, 2022, View Source [SID1234622245]). Biohaven has granted the underwriters a 30-day option to purchase up to an additional 3,750,000 common shares. The offering is expected to close on October 25, 2022, subject to the satisfaction of customary closing conditions. Biohaven intends to use the net proceeds received from the offering for general corporate purposes.

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J.P. Morgan, Cowen, SVB Securities and Piper Sandler are acting as joint book-running managers of the offering. Cantor and BTIG are acting as co-managers.

The offering will be made only by means of a prospectus. A copy of the prospectus relating to this offering, when available, may be obtained from the following sources: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at [email protected]; 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 by email at [email protected]; SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at [email protected]; or by accessing the U.S. Securities and Exchange Commission’s website at www.sec.gov.

A registration statement on Form S-1 relating to the securities has been filed with the Securities and Exchange Commission (the "SEC") and was declared effective by the SEC on October 20, 2022. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities, nor shall there be any sale of the securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the applicable securities laws of such state or jurisdiction.

On October 20, 2022 Median Technologies (Euronext Growth – ALMDT) (Paris:ALMDT), whose Board of Directors approved on October 18, 2022 the consolidated IFRS financial statements for the first half of 2022 after a limited review, reported its half-year results as well as revenues for the third quarter of 2022 (Press release, MEDIAN Technologies, OCT 20, 2022, View Source [SID1234622244]).

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Fredrik Brag, CEO and Founder of Median Technologies said:

"We are very pleased that in this uncertain economic environment, Median continues to deliver double digit growth of its revenues and backlog.
We can already observe the very strong impact of the launch of Imaging Lab in May 2022, which is generating significant traction with biopharma companies. Median is positioning itself to become the strategic partner to extract insights from medical images by applying AI solutions to better understand the mechanism of action of new drugs. Therefore, we are becoming the natural provider for clinical studies. With this strong and unique differentiator, we expect to see a clear impact on our iCRO order backlog in the coming months.
Our iBiopsy activities have also been very intense during the quarter with the formation of a first class clinical advisory board and our continued interaction with the FDA for our iBiopsy LCS CADe/CADx SaMD which is following its natural course. We still expect to start our pivotal study in the coming months. Furthermore, the European Union has announced that lung cancer screening1 will become one of the main priorities for the new cancer plan "Europe’s beating cancer plan", which should substantially increase our total addressable market in the coming years."

Further growth during Q3 2022

Third quarter revenues amounted to €6.0 million, representing a 13% increase compared to Q3 2021 revenues (€5.3 million). Revenues for the first three quarters of 2022 were €18.7 million, up 21% compared to the €15.4 million for the first three quarters of 2021. Revenues are entirely generated by the iCRO2 business, which provides imaging services to the biopharmaceutical industry worldwide for oncology clinical trials.

The order backlog3 was €62.5 million on September 30, 2022 , up €8.3 million compared to September 30, 2021 (€54.2 million, +15%).

Cash and cash equivalents totaled €25.9 million on September 30, 2022, including receipt of the 2021 research and innovation tax credit for €1.6 million, and benefiting from the collection of late payments from the second quarter by the Chinese subsidiary following the lockdown in the Shanghai region.

Financial information at June 30, 2022 (IFRS consolidated financial statements)

Median Technologies continued robust growth momentum during the first half of 2022 .

The Company continued the development program of its iBiopsy Lung Cancer Screening (LCS) CADe/CADx software as medical device (SaMD), which resulted in an increase of the cash flow deficit, partially offset by the additional margins generated by the growing iCRO business.

Working capital requirements deteriorated temporarily due to the closure of Chinese administration offices during the lockdown in Shanghai, which delayed the invoicing and collection process for trade receivables. On June 30, 2022, the Group estimated late payments of €2.5 million.

The operating loss reached (€11.0) million, representing an increase of €6.5 million relative to the year-earlier period, including €4.3 million due to the accounting under IFRS of free share allocations made in October 2021 for the Group’s employees and management (with no cash impact), and also due to the investments made for research and development work for the iBiopsy platform.

The increase in revenues and the margin generated by the iCRO business helped reduce the impact of investments in iBiopsy on operating result.

Financial result reached €2.4 million, due primarily to an IFRS accounting valuation adjustment (with no cash impact) of the equity warrants issued in favor of the EIB with the drawing of the first €15 million tranche of its loan in H1 2020. This valuation has been significantly impacted by changes in the share price since the issue of these warrants. Although it is recorded in the statement of financial position under financial instruments, no reimbursement will be made that could affect the Group’s cash in the future.