On May 17, 2021 Orion Biotech Opportunities Corp. (the "Company") reported the closing of its initial public offering ("IPO") of 20,000,000 units at a price of $10.00 per unit, resulting in total gross proceeds of $200,000,000 (Press release, Orion Biotechnology, MAY 17, 2021, View Source [SID1234580232]). The Company’s units began trading on The Nasdaq Capital Market (the "Nasdaq") under the symbol "ORIAU" on May 13, 2021.

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Each unit consists of one of the Company’s Class A ordinary shares and one-fifth of one redeemable warrant, with each whole warrant entitling the holder thereof to purchase one Class A ordinary share at a price of $11.50 per share. Once the securities comprising the units begin separate trading, the Class A ordinary shares and warrants are expected to be listed on the Nasdaq under the symbols "ORIA" and "ORIAW," respectively.

Orion Biotech Opportunities Corp. is a newly incorporated special purpose acquisition company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization, or similar business combination with a target in a growth-oriented sector, including technology and media.

Cantor Fitzgerald & Co. acted as the sole book-running manager for the offering. The Company has granted the underwriter a 45-day option to purchase up to 3,000,000 additional units to cover over-allotments, if any.

The offering was made by means of a prospectus, copies of which may be obtained, when available, from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 5th Floor New York, New York 10022; Email: [email protected].

A registration statement relating to these securities has been declared effective by the U.S. Securities and Exchange Commission (the "SEC") on May 12, 2021. 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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

A registration statement relating to these securities has been declared effective by the U.S. Securities and Exchange Commission (the "SEC") on March 24, 2021. 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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 17, 2021 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported that it is postponing its previously announced investor conference call scheduled to be held on Monday, May 17, 2021, at 2 p.m. Pacific Time (Press release, Adamis Pharmaceuticals, MAY 17, 2021, View Source [SID1234580214]). The company filed a Form 12b-25 with the Securities and Exchange Commission today in order to extend the due date of its Quarterly Report on Form 10-Q for the three months ended March 31, 2021, by five calendar days as permitted by Rule 12b-25 under the Securities Exchange Act of 1934, and is postponing the investor call in light of that filing delay. The company will announce a new date and time for a rescheduled investor call.

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On May 17, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported its financial results for the three months ended March 31, 2021 and provided a business update (Press release, Sonnet BioTherapeutics, MAY 17, 2021, View Source [SID1234580194]).

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"Over the course of the quarter, we have made several advancements across our pipeline products, most notably of which are the completion of non-human primate (NHP) toxicology study of SON-080 and the completion of a repeat dose study of SON-1010 in NHPs," commented Pankaj Mohan, Ph.D., Founder and CEO. "Additionally, we were thrilled to have our abstract detailing data from our NHP study of SON-1010 accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting."

FY 2021 Second Quarter and Recent Corporate Updates

Sonnet provided the following updates on its lead pipeline assets:

The Company successfully completed multiple NHP GLP toxicology studies with SON-1010 (FHAB-IL12) and is generating data to prepare an IND submission to initiate clinical studies in the second half of 2021.

Regarding SON-080, the Company intends to file a US IND to initiate a Phase 1b/2a pilot-scale efficacy study in the Chemotherapy-Induced Peripheral Neuropathy (CIPN) indication during the second half of 2021. Additionally, as part of the recently announced partnership with New Life Therapeutics, the companies intend to file an ex-US IND equivalent for a Phase 1b/2a pilot-scale efficacy study in Diabetic Peripheral Neuropathy (DPN) during the second half of 2021. Going forward, Sonnet will exclusively refer to the low-dose IL-6 programs, namely CIPN and DPN, using the SON-080 designation, the latter of which had previously been known as the SON-081 program.

The Company’s first bispecific candidate, SON-1210 (IL-FHAB-IL15), is undergoing cell line and process development activities. Sonnet expects completion of NHP studies in the second half of this year with an IND submission during the first half of 2022.

Sonnet has manufactured bi-specific preclinical constructs of SON-2014 (GMcSF-FHAB-IL18), as well as IL18-FHAB-IL12 and IL12-FHAB-GMcSF that are being evaluated for in vivo efficacy, biomarker profiles and fluorescence-activated cell sorting (FACS) assessment in single dose and multi-dose preclinical studies. The Company intends to initiate commercial cell line development necessary for future clinical studies, with an IND submission for SON-2014 targeted for the second half of 2022.

Sonnet has added key senior management hires of Richard Kenney, M.D. as Chief Medical Officer and Manuel Dafonseca as Head of Clinical Operations, as the Company prepares to advance its FHAB platform into its first clinical study.

"During the quarter, we were able to successfully draw from our at-the-market sales agreement with BTIG and bring in over $10 million of capital to the Company", commented Jay Cross, CFO. "This additional funding will enable us to continue driving our R&D activities forward and furthers our goal of bringing much need therapeutic advancements to patients."

FY 2021 Second Quarter Ended March 31, 2021 Financial Results

●As of March 31, 2021, Sonnet had $6.7 million cash on hand.
●As previously announced, on February 5, 2021, Sonnet entered into an at-the-market sales agreement with BTIG, LLC, for an aggregate offering of up to $15.9 million. Through March 31, 2021, the Company sold an aggregate of 4,021,561 shares for net proceeds of $10.2 million to Sonnet. The company has not sold shares though this facility since March 12, 2021.
●Research and development expenses were $3.8 million for the three months ended March 31, 2021, compared to $1.3 million for the three months ended March 31, 2020. The increase of $2.5 million was primarily due to increased expenditures for the development of the cell line for IL12-FHAB and IL12-FHAB-IL15

General and administrative expenses were $2.2 million for the three months ended March 31, 2021, compared to $1.3 million for the three months ended March 31, 2020. The increase of $1.0 million was primarily due to an increase in insurance expense of related to directors and officer’s insurance, and in increase in payroll and share-based compensation expense to support our expanded operations.

On May 17, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported the receipt of $4.5 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2020 (Press release, PDS Biotechnology, MAY 17, 2021, View Source [SID1234580192]).

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"We are pleased to receive an allocation from the New Jersey NOL program," said Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. "The funding will be beneficial to us as we continue to efficiently utilize our resources to advance our immuno-oncology pipeline through development."

The NOL program enables qualified, unprofitable NJ-based technology or biotechnology companies with fewer than 225 U.S. employees (including parent company and all subsidiaries) to sell a percentage of net operating losses and research and development (R&D) tax credits to unrelated profitable corporations. This allows qualifying technology and biotechnology companies with NOLs to turn their tax losses and credits into cash proceeds to fund growth and operations, including research and development or other allowable expenditures. PDS Biotech is one of 49 early-stage companies to share in approximately $54.5 million of tax credit transfers approved by NJEDA for the 2020 period.

On May 17, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products in Greater China and other parts of Asia, reported that the China National Medical Products Administration (NMPA) has accepted for review its Biologics License Application for sacituzumab govitecan-hziy (SG), an investigational therapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease (Press release, Everest Medicines, MAY 17, 2021, View Source [SID1234580175]).

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"This aggressive and difficult-to-treat disease has historically had very limited treatment options, with overall survival remaining unchanged among patients for nearly two decades," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "The outstanding and robust efficacy and safety results from the global Phase 3 ASCENT study demonstrate SG is an important potential new treatment option for people in China with metastatic TNBC."

"We are excited to achieve this important milestone as we work to advance access to this first-of-its-kind therapy for patients with metastatic TNBC in China and the Asia Pacific region. The speed at which this milestone is achieved is a testament to our steadfast commitment to accelerating global pharmaceutical innovation in diseases with critical unmet needs," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines.

Under the trade name Trodelvy, the U.S. Food and Drug Administration previously granted accelerated approval to SG in April 2020 and full approval in April 2021 for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.

The Ministry of Food and Drug Safety in South Korea has also recently granted Fast Track Designation and Orphan Drug Designation to SG for the treatment of metastatic TNBC. In addition, Everest announced in January 2021 that it submitted a New Drug Application to the Health Sciences Authority of Singapore for SG for the treatment of patients with metastatic TNBC who have received at least two prior therapies for metastatic disease. That application is currently under review.

About Triple-Negative Breast Cancer

Triple-negative breast cancer (TNBC) is a highly aggressive disease and accounts for approximately 15% of all breast cancer types worldwide. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells lack sufficient estrogen, progesterone or HER2 receptor expression to benefit from the use of hormonal or HER2-directed therapy. Overall survival among patients with this form of breast cancer has not changed in the past 20 years, which highlights the need for advances in therapeutic options for these patients.

About Sacituzumab Govitecan-hziy

Sacituzumab govitecan-hziy (SG) is a first-in-class antibody and topoisomerase inhibitor conjugate directed at TROP-2, a protein frequently expressed in multiple types of epithelial cancers. SG is approved in the United States under the trade name Trodelvy. The U.S. approval was supported by data from the Phase 3 ASCENT study, which demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival or PFS), extending median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001). SG also extended median overall survival (OS) to 11.8 months vs. 6.9 months (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001), representing a 49% reduction in the risk of death.

The most frequent Grade ≥3 adverse reactions for SG compared to single-agent chemotherapy in the study were neutropenia (52% vs. 34%), diarrhea (11% vs. 1%), leukopenia (11% vs. 6%) and anemia (9% vs. 6%). Adverse reactions leading to treatment discontinuation occurred in 5% of patients receiving SG. The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, SG was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.