On December 10, 2020 XOMA Corporation (Nasdaq: XOMA) ("XOMA" or the "Company") reported it has commenced an underwritten registered public offering of shares of its Series A Cumulative Perpetual Preferred Stock, with liquidation preference of $25.00 per share (the "Preferred Stock") (Press release, Xoma, DEC 10, 2020, View Source [SID1234572615]). The Company expects to grant the underwriters a 30-day option to purchase additional shares of the Preferred Stock in connection with the offering.

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The Company expects to use the net proceeds of this offering to fund the segregated dividend account and the remaining net proceeds for general corporate purposes, including funding future acquisitions of milestone and royalty rights associated with drug development programs with third-party funding.

B. Riley Securities, Inc., Ladenburg Thalmann & Co. Inc., National Securities Corporation, and William Blair & Company are acting as joint book-runners for this offering. Aegis Capital Corp., Boenning & Scattergood, Inc., and Northland Capital Markets are acting as co-managers.

The offering of these securities is being made pursuant to an effective shelf registration statement on Form S-3, which was initially filed with the Securities and Exchange Commission (the "SEC") on March 7, 2018, and declared effective by the SEC on April 5, 2018. The offering will be made only by means of a prospectus and prospectus supplement. A copy of the prospectus and prospectus supplement relating to these securities may be obtained, when available, from the website of the SEC at View Source or by contacting: B. Riley Securities, Inc., 1300 17th Street North, Suite 1300, Arlington, Virginia 22209, Attn: Prospectus Department, Email: [email protected], Telephone: (703) 312-9580.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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.

On December 10, 2020 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported enrollment and apheresis of the first patient in the Phase 1/2 clinical trial for BPX-603 in patients with tumors that express human epidermal growth factor 2 (HER2) (Press release, Bellicum Pharmaceuticals, DEC 10, 2020, View Source [SID1234572614]). BPX-603 is Bellicum’s first dual switch GoCAR-T product candidate that incorporates the company’s iMC activation and CaspaCIDe safety switch technologies.

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"Initiation of this Phase 1/2 dose escalation clinical trial for BPX-603 denotes an important achievement for Bellicum and represents our second GoCAR-T program to enter the clinic," stated Rick Fair, President and CEO. "This program may provide further validation of our technology’s ability to enhance both the efficacy and safety of immune cell therapy against solid tumors. We are excited to advance this potentially life-saving treatment approach into the clinic."

BPX-603 Phase 1/2 Clinical Trial Design

This Phase 1/2, open-label, multicenter, non-randomized study will investigate the safety, tolerability, and clinical activity of HER2-specific dual-switch CAR-T cells, BPX-603, administered with rimiducid. The trial will enroll patients with previously treated, locally advanced or metastatic solid tumors with HER2 amplification or overexpression. The initial dose escalation phase of the trial is designed to evaluate safety and identify the Phase 2 dose of BPX-603 administered with rimiducid at a fixed dose of 0.4 mg/kg per infusion. The Phase 2 portion of the trial will assess the safety, pharmacodynamics, and clinical activity of BPX-603 in various HER2+ solid tumors. Tumor types that may be studied include gastric, breast, ovarian, endometrial, and colorectal.

About BPX-603

HER2 is a validated antigen for cancer therapies and academic CAR-T cell clinical studies have shown evidence of modest antitumor activity. BPX-603 was designed to improve upon these efforts, primarily through incorporation of the inducible co-activation domain MyD88/CD40, or "iMC". MC signaling is believed to boost effector cell proliferation and survival, enhance functional persistence by resisting exhaustion and the suppressive tumor microenvironment, and stimulate the cancer patient’s own immune system. Additionally, Bellicum’s dual-switch technology—which enables the clinician to either activate or eliminate GoCAR-T cells with the administration of small molecules—is designed to enhance real-time control of both efficacy and safety.

On December 10, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that CEO, Gil Beyen, will present at the JMP Securities Hematology Summit Tuesday December 15th at 1:30pm EST /06:30pm GMT /7:30pm CET (Press release, ERYtech Pharma, DEC 10, 2020, View Source [SID1234572612]). The format will be a "fireside chat" discussion hosted by JMP Securities’ Reni Benjamin.

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On December 10, 2020 Biodesix, Inc. a leading data-driven diagnostic solutions company with a focus in lung disease, reported financial and operating results for the third quarter ended September 30, 2020 and provided a corporate update (Press release, Biodesix, DEC 10, 2020, View Source [SID1234572611]).

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Third Quarter 2020 and Recent Highlights

Generated record quarterly revenue of $9.2 million for the third quarter ended September 30, 2020.
Completed initial public offering (IPO) that raised net proceeds of approximately $63 million after deducting offering costs, underwriting discounts and commissions.
Announced a strategic partnership with the Big Ten Conference whereby Biodesix is conducting ddPCR COVID-19 validation testing and managing the onsite testing of rapid antigen SARS-CoV-2 testing for all student-athletes and staff personnel involved in close contact sports competition.
Published an extended analysis of data from the company’s Nodify XL2 lung nodule test in the American College of Chest Physicians (CHEST) Journal. The data demonstrate that all nodules in the study group that were established as benign after one year remained benign after two years, the guideline-recommended surveillance period to radiologically confirm a benign diagnosis.
Presented data from three studies at the American College of Chest Physicians (CHEST 2020) Annual Meeting highlighting the clinical value of the company’s Nodify XL2 and Nodify CDT lung nodule risk assessment tests.
"We recently achieved a very significant milestone with our IPO and transition to a public company," stated Scott Hutton, Chief Executive Officer of Biodesix. "With the proceeds from the offering, we plan to continue to market our suite of commercially available diagnostic tests, including our Biodesix Lung Reflex and Nodify Lung testing strategies, in addition to our COVID-19 testing, while also investing in the discovery, development, and validation of innovative new tests leveraging our proprietary AI-driven discovery platform.

"We continue to monitor the COVID-19 pandemic carefully in light of the recent surge in case counts around the country, and we are pleased to be able to play an important part in the fight against this dangerous virus through our WorkSafe testing program. To this point, our lung disease-focused core business continues to perform well even while healthcare facilities devote time and resources to combat COVID-19 and travel restrictions affect our commercial efforts. We believe this is a testament to the valuable clinical information that our tests provide along critical points of the lung disease care continuum," concluded Mr. Hutton.

Financial Results

Revenue. Revenue for the three months ended September 30, 2020 was $9.2 million, as compared to $3.9 million for the comparable period in 2019, an increase of 133%. This increase was due to $5.5 million of revenue from our two COVID-19 diagnostic tests, partially offset by a modest decline in our non-COVID-19 diagnostic test volumes of $0.7 million as health care practitioners, including pulmonologists, were increasingly diverted to pandemic-related care. In addition, company sales efforts continued to be impacted by travel and other COVID-19 pandemic related restrictions. Revenue for the nine months ended September 30, 2020 was $18.5 million, as compared to $16.3 million for the comparable period in 2019, an increase of 14%.

Direct costs and expenses. Direct costs and expenses for the three months ended September 30, 2020 were $3.9 million, as compared to $1.5 million for the comparable period of 2019, an increase of 159%. Direct costs and expenses for the nine months ended September 30, 2020 were $7.3 million compared to $4.2 million for the nine months ended September 30, 2019, an increase of 73%. The increase in costs were primarily driven by the release of the company’s Nodify CDT test and its COVID-19 testing program in 2020.

Research and development. Research and development expenses for the three months ended September 30, 2020 were $2.7 million, as compared to $2.4 million for the comparable period in 2019, an increase of 15%. Research and development expenses for the nine months ended September 30, 2020 were $7.7 million, as compared to $8.0 million for the comparable period in 2019, a decrease of 3%.

Sales, marketing, general and administrative. Sales, marketing, general and administrative expenses for the three months ended September 30, 2020 were $7.9 million, as compared to $8.2 million for the comparable period in 2019, a decrease of 4%. Sales, marketing, general and administrative expenses for the nine months ended September 30, 2020 were $22.8 million, as compared to $24.1 million for the comparable period in 2019, a decrease of 5%. The decrease was driven by reductions in travel and related expenses as the COVID-19 pandemic reduced or eliminated the travel and related expenses.

Operating loss. Operating loss for the three months ended September 30, 2020 was $6.2 million, as compared to an operating loss of $9.0 million for the comparable period in 2019, a decrease of 31%. Operating loss for the nine months ended September 30, 2020 was $20.3 million, as compared to an operating loss of $23.2 million for the comparable period in 2019, a decrease of 13%. The decrease was due in part to higher revenue in the third quarter of 2020 as compared to the third quarter of 2019.

Net loss. Net loss for the three months ended September 30, 2020 was $8.9 million, as compared to $9.6 million for the comparable period in 2019, a decrease of 8%. Net loss for the nine months ended September 30, 2020 was $26.8 million, as compared to $24.2 million for the comparable period in 2019, an increase of 11%.

Cash and cash equivalents. As of September 30, 2020, the company held cash and cash equivalents of $6.3 million, as compared to $5.3 million as of December 31, 2019. Subsequent to the end of the third quarter, the company completed a successful initial public offering that raised net proceeds of approximately $63 million. As a result of the completion of the initial public offering, the company estimates that it has sufficient cash resources to meet its cash obligations through at least the next 12 months.

On December 10, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported the selection of three abstracts for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, taking place virtually on January 15 – 17, 2021 (Press release, Zymeworks, DEC 10, 2020, View Source [SID1234572610]).

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The presentations highlight updated clinical data for the HER2-targeted bispecific antibody, zanidatamab, in HER2-expressing gastroesophageal adenocarcinoma (both as monotherapy and in combination with chemotherapy) and in HER2-expressing/amplified biliary tract cancer (as monotherapy). Zymeworks is currently recruiting globally in a pivotal clinical trial in patients with HER2-amplified biliary tract cancer for which a "trial in progress" poster will also be presented during the meeting.

Oral Presentation Session

Title: Zanidatamab (ZW25) in HER2-expressing gastroesophageal adenocarcinoma (GEA):

Results from a phase I study

Lead Author: Funda Meric-Bernstam, MD, UT MD Anderson Cancer Center, TX

Abstract: 164

Rapid Abstract Session: Esophageal and Gastric Cancer

Date and Time: January 15, 2021 at 11:30 am – 12:15 pm ET

Poster Presentations

The poster presentations will be available on Friday, January 15 at 8:00 am ET on the conference website as well as the Zymeworks website.

Title: Zanidatamab (ZW25) in HER2-positive biliary tract cancers (BTCs): Results from a phase I study.

Lead Author: Funda Meric-Bernstam, MD, UT MD Anderson Cancer Center, TX

Abstract: 299

Poster Session: Hepatobiliary Cancer

Title: A phase IIb, open-label, single-arm study of zanidatamab (ZW25) monotherapy in subjects with advanced or metastatic HER2-amplified biliary tract cancers (BTCs).

Lead Author: Shubham Pant, MD, UT MD Anderson Cancer Center, TX

Abstract: TPS352

Trials in Progress Poster Session: Hepatobiliary Cancer

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade,

increased binding, and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and registration-enabling clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as monotherapy for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations for the treatment of biliary tract, gastric and ovarian cancers, as well as Orphan Drug designation for the treatment of gastric cancer from the European Medicines Agency.