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.

On December 10, 2020 Ambrx Inc., a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code, reported a clinical update on their lead program ARX788, a homogeneous and highly stable, site-specific antibody drug conjugate (ADC) targeting HER2 positive cancers (Press release, Ambrx, DEC 10, 2020, View Source [SID1234572609]).

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"As presented at the 2020 San Antonio Breast Cancer Symposium, ARX788 Phase 1 studies demonstrated promising antitumor activity in heavily pre-treated cancer patients at the recommended Phase 2 dose," said Joy Yan, MD, PhD, Ambrx Chief Medical Officer.

• ORR of 74% (14/19) and DCR of 100% in the 1.5 mg/kg cohort of the Phase 1 HER2-positive breast cancer trial in China
• ORR of 67% (2/3) and DCR of 100% in the 1.5 mg/kg cohort of Phase 1 HER2-positive pan tumor trial in U.S. and Australia
• mDOR or mPFS at the 1.5 mg/kg dose have not been reached.
• ARX788 was well-tolerated, with most adverse events being mild or moderate, and were manageable.

Patients who failed prior Kadcyla (T-DM1) or Enhertu (DS-8201a) achieved clinical responses, as assessed by RECIST v1.1 in the ACE-Pan Tumor-01 (ARX788-1711) trial, which enrolled patients with HER2 expressing cancers including breast cancer, gastric/gastroesophageal junction adenocarcinoma, non-small cell lung cancer, bladder, colorectal, biliary track, and salivary gland cancers in US and Australia.

"The randomized controlled Phase 2/3 HER2-positive breast cancer pivotal trial in China has treated 22 subjects as of December 5th, 2020 and continues to quickly enroll patients," said Dr. Xichun Hu, the leading PI of the ongoing ARX788 Phase 1 and Phase 2/3 trials in China.
"We remain on track to open multiple global ARX788 registrational studies next year, with the first study in HER2-positive breast cancer patients who failed prior T-DM1, T-DXd, or tucatinib-containing regimens starting in early 2021. These global registrational studies are designed to obtain BLA and sBLA in HER2 positive breast cancer, HER2 positive gastric cancer, HER2-low breast cancer, and other HER2-expressing or HER2-mutated solid tumors," said Dr. Yan.

About ARX788
ARX788 is a homogeneous and highly stable antibody drug conjugate (ADC) targeting the HER2 receptor. ARX788 is a Precision Biologic ADC that consists of two cytotoxic payloads site-specifically conjugated to a Herceptin (trastuzumab) based antibody. ARX788 was designed for maximum performance in the preclinical setting by optimizing the number, position and chemical bonds that conjugate the cytotoxic AS269 payload to the antibody. AS269 is a proprietary tubulin inhibitor specifically designed to form a highly stable covalent bond with our synthetic amino acids, a fundamental step in the creation of a Precision ADC. Ambrx is developing and commercializing ARX788 with its partner NovoCodex.

On December 10, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported the pricing of an underwritten public offering of 3,333,335 shares of its common stock at a price to the public of $9.00 per share (Press release, Avid Bioservices, DEC 10, 2020, View Source [SID1234572608]). The gross proceeds from this offering are expected to be approximately $30 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Avid Bioservices, Inc. The offering is expected to close on or about December 14, 2020, subject to customary closing conditions. Avid Bioservices, Inc. has also granted the underwriters a 30-day option to purchase from it up to an additional 500,000 shares of common stock at the public offering price, less underwriting discounts and commissions. Avid Bioservices, Inc. intends to use the net proceeds from the offering primarily for the expansion of its manufacturing capabilities and any remainder for general corporate purposes.

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RBC Capital Markets is acting as sole book-running manager for the offering. Craig-Hallum Capital Group and Stephens Inc. are acting as co-managers for the offering.

The shares described above are being offered by Avid Bioservices, Inc. pursuant to a shelf registration statement on Form S-3 previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the offering has also been filed with the SEC and is available on the SEC’s website at View Source Copies of the preliminary prospectus supplement and accompanying base prospectus relating to this offering may be obtained from RBC Capital Markets, LLC, Attn: Equity Capital Markets, 200 Vesey Street, New York, NY 10281, by telephone at 877-822-4089 or by email at [email protected], Craig-Hallum Capital Group LLC, Attn: Equity Capital Markets, 222 South Ninth Street, Suite 350, Minneapolis, MN 55402, by telephone at (612) 334-6300 or by e-mail at [email protected] or from Stephens Inc., Attn: Equity Syndicate, 111 Center Street, Little Rock, AR 72201, by telephone at (501) 377-2000 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any offer, sale or solicitation of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful.