On June 1, 2020 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported the completion of an underwritten public offering of 22,044,447 shares of its common stock, including 3,333,334 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares, and of pre-funded warrants to purchase up to an aggregate of 3,511,111 shares of common stock (Press release, BioCryst Pharmaceuticals, JUN 1, 2020, View Source [SID1234560722]). The gross proceeds from this offering to BioCryst, including from the shares sold pursuant to the underwriters’ option to purchase additional shares, were approximately $115 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by BioCryst.

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BioCryst expects to use the net proceeds of this offering for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory, pre-launch and commercial activities for the prophylactic berotralstat (BCX7353) program in the United States and European Union; advancement of the worldwide development, manufacturing, regulatory and clinical activities for BCX9930 for complement-mediated diseases; post-approval commitments for RAPIVAB/ALPIVAB; and capital expenditures and other general working capital needs.

J.P. Morgan and Piper Sandler acted as joint book-running managers for the offering. H.C. Wainwright & Co. and JMP Securities acted as lead managers for the offering.

A shelf registration statement on Form S-3 relating to the shares of common stock described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission (SEC). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

This offering was made by means of a prospectus supplement and related prospectus. A prospectus supplement relating to the offering has been filed with the SEC and is available on its website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 1-866-803-9204 or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by email at [email protected].

On June 1, 2020 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported the preliminary results of the Phase 1a clinical study (NCT03875157) of the recombinant fully human anti-programmed bispecific antibody IBI318 against programmed death receptor 1 (PD-1) and programmed death ligand 1 (PD-L1) in patients with advanced tumors at the 56th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract # 3062, Poster #126, 8:00 AM – 11:00 AM, U.S. Central Time, Friday, May 29, 2020) (Press release, Innovent Biologics, JUN 1, 2020, View Source [SID1234560739]).

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The NCT03875157 study presented at the ASCO (Free ASCO Whitepaper) annual meeting was a Phase 1 clinical study conducted in China to evaluate the safety, tolerability and anti-tumor activity of IBI318 in subjects with advanced tumors. The main clinical data include:

As of January 10, 2020, a total of 15 subjects had enrolled in the 1a dose escalation phase, and the dose exploration phase of 600 mg Q2W is currently ongoing. A total of 11 subjects experienced treatment-related adverse events (TRAEs) and the most common TRAEs were pyrexia (20.0%, G1/2) and infusion reactions (20.0%, G1/2). There were no Grade 3 or higher TRAEs. One subject had a Grade 2 immune-related arthritis at a dose of 300 mg.
Twelve subjects had at least 1 tumor assessment, and 9 subjects received IBI318 treatment at doses of 10 mg and above, with 3 subjects experiencing an objective response.
Professor Ruihua Xu, the leader of the study and President of Zhongshan Cancer Prevention and Control Center, said: "Immunotherapy is entering into the era of bispecific antibodies from monoclonal antibodies. The preliminary results from NCT03875157 study show that IBI318, a first-in-class bispecific antibody, has an acceptable safety profile. We are hopeful to see positive results from the following studies to help more patients in need. "

About IBI318 (Anti-PD-1/PD-L1 Bispecific Antibody)

IBI318 is an innovative recombinant fully human IgG1 bispecific antibody that restores T cell activation and anti-tumor function by blocking PD-1 and PD-L1/PD-L2 signaling pathways, and blocking PD-L1 binding CD80 signaling pathway. IBI318 is expected to improve anti-tumor activity and efficacy by bridging PD-1-expressing T cells and PD-L1-expressing tumor cells through its bispecific ability to form an immune synapse between the two.

On June 1, 2020 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the first quarter ended March 31, 2020, and provided a business update on recent corporate and clinical developments (Press release, Protalix, JUN 1, 2020, View Source [SID1234558782]). The Company’s management will discuss the financial results and provide a clinical, corporate and financial highlights on a conference call and live webcast scheduled for Monday, June 1, 2020 at 8:30 am Eastern Daylight Time (EDT).

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"The first quarter of 2020 has most certainly been transformational for Protalix, despite the COVID-19 pandemic that affected the global markets," said Dror Bashan, Protalix’s President and Chief Executive Officer. "I am proud to say that despite the pandemic, Protalix was able to keep the company running smoothly and adapt quickly to the changing environment."

"During the quarter, we were able to close a $43.7 million private placement," he continued. "Furthermore, the topline results from the completion of our Phase III BRIDGE study and the subsequent BLA submission for PRX-102 announced in May prove that Protalix has actually gained momentum by leaning into this unprecedented challenge. I am convinced now more than ever that our team is positioned for long-term success and look forward to continuing our momentum through the rest of this year and into 2021."

Conference Call and Webcast Information

The Company will host a conference call on Monday, June 1, 2020, at 8:30 am, Eastern Daylight Time, to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

First Quarter 2020 and Recent Business Highlights

Clinical and Regulatory Advancements

·On May 28, 2020, the Company and its development and collaboration partner, Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A., or Chiesi, announced the submission on May 27, 2020 of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa, or PRX-102, for the treatment of adult patients with Fabry disease via the FDA’s Accelerated Approval pathway. PRX-102 was granted Fast Track designation by the FDA in January 2018. Upon the BLA approval, if approved, the Company will be eligible to receive a milestone payment from Chiesi.

·On May 11, 2020, the Company announced positive topline results following the completion of its Phase III BRIDGE clinical trial of PRX-102 for the treatment of Fabry disease. The Phase III BRIDGE clinical trial, a 12-month open-label, single arm switch-over study evaluating the safety and efficacy of PRX-102, 1 mg/kg infused every two weeks, met its main objectives for safety and efficacy, and topline analysis indicated substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in patients switched from agalsidase alfa to PRX-102.

·On February 6, 2020, Protalix and Chiesi announced the receipt of an agreement letter from the FDA for the Initial Pediatric Study Plan (iPSP) for PRX-102 for the treatment of Fabry disease, outlining an agreed-upon approach to address the needs of pediatric Fabry patients.

Corporate & Financial Developments

·On March 16, 2020, the Company announced that it has agreed to conduct a feasibility study with Kirin Holdings Company, Limited, or Kirin, to evaluate the production of a novel complex protein utilizing ProCellEx. The Company received a non-refundable payment of $1.0 million and Kirin will provide research funding for the Company’s scientists to conduct cell line engineering and protein expression studies on the target protein.

·On March 12, 2020, the Company entered into securities purchase agreements with certain existing and new institutional and other accredited investors in a private placement. Pursuant to such agreements, the Company issued and sold to the purchasers an aggregate of approximately 17.6 million unregistered shares of its common stock at a price per share of $2.485, or aggregate net committed proceeds equal to approximately $41.3 million. Each share of the Company’s common stock issued in the transaction was accompanied by a warrant to purchase an additional share of common stock at an exercise price equal to $2.36.

Financial Results

For the three months ended March 31, 2020, compared to the three months ended March 31, 2019

·The Company recorded revenues from selling goods of $5.0 million during the three months ended March 31, 2020, an increase of $1.5 million, or 43%, compared to revenues of $3.5 million for the same period of 2019. The increase resulted primarily from an increase of $0.8 million in sales of drug product to Brazil as well as an increase of $0.7 million in sales of drug substance to Pfizer Inc.

·Revenues from license and R&D services for the three months ended March 31, 2020, were $16.6 million, an increase of $9.7 million, or 140%, compared to revenues of $6.9 million for the same period of 2019. Revenues from the license agreements represent the revenues recognized in connection with previously announced agreements with Chiesi. The increase is primarily due to revenues recognized in connection with the progress of the Company’s clinical trial that have been performed, and with revenues recognized in connection with an updated costs estimation throughout the trials until completion in the amount of $6.7 million.

·Cost of goods sold was $3.4 million for the three months ended March 31, 2020, an increase of $1.4 million, or 68%, from cost of goods sold of $2.0 million for the same period of 2019. The increase is primarily due to an increase in sales of goods.

·Research and development expenses were $10.3 million for the three months ended March 31, 2020, a decrease of $1.4 million, or 12%, compared to $11.7 million of research and development expenses for the same period of 2019. The decrease was primarily due to a decrease in costs related to manufacturing of our drug in development.

·Selling, general and administrative expenses were $3.2 million for the three months ended March 31, 2020, an increase of $1.0 million, or 43%, compared to $2.2 million for the same period of 2019. The increase resulted primarily from a $0.6 million increase in compensation related costs and a $0.2 million increase in professional fees.

·Net income for the three months ended March 31, 2020 was $1.7 million, or $0.10 per share, basic and diluted, compared to a net loss of $7.3 million, or $0.50 per share, basic and diluted, for the same period of 2019.

On June 1, 2020 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the "Company") reported that Peter Greenleaf, President and Chief Executive Officer of Aurinia, will participate in a fireside chat during the 2020 Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 3:30 p.m. EDT (Press release, Aurinia Pharmaceuticals, JUN 1, 2020, View Source [SID1234560723]).

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In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

On June 1, 2020 Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, reported to share a poster presentation of interim data from the ongoing phase II study of paxalisib (formerly GDC-0084) in glioblastoma, the most common and most aggressive form of primary brain cancer (Press release, Kazia Therapeutics, JUN 1, 2020, View Source [SID1234560740]). Top-line data from this interim analysis was previously announced to ASX on 7 April 2020.

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Key Points

Analysis of Stage 1 of the study (n=9) shows median overall survival (OS) of 17.7 months. This compares very favourably with temozolomide, the existing standard of care, which has a reported median OS of 12.7 months in this patient population
Progression-free survival (PFS) in Stage 1 was 8.4 months, which represents a clinically material advantage over the 5.3 months associated with temozolomide
The longest-treated patient remains on therapy and progression-free some 19 months after diagnosis
Safety profile is consistent with prior clinical experience. Rash, mucositis, and hyperglycemia are the most common toxicities, and 60mg, once daily, orally, was confirmed as the maximum tolerated dose (MTD)
Professor Patrick Wen from Dana-Farber Cancer Institute, who was the lead author on the poster presentation, commented, "These are encouraging early signals. We anticipate paxalisib will move into a pivotal study later this year and look forward to reviewing further data as it emerges."

Kazia CEO, Dr James Garner, added, "We are pleased to be able to share these extremely promising data with clinicians and partners, albeit in the novel forum of a virtual academic meeting. As we have previously said, the gold standard for any new cancer drug is the ability to extend life, and we are seeing evidence from this study that paxalisib may achieve this very challenging goal. We expect to begin recruitment to the international GBM AGILE pivotal study in the second half of this year. In the meantime, we expect several further data read-outs over the next two quarters."

Summary of Paxalisib Data in Comparison to Temozolomide (existing standard of care)

Temozolomide
(FDA-approved treatment)

Paxalisib

(Stage 1 of Phase II Study)

Progression-Free Survival (PFS)

Measures ability of a drug to slow
growth of a tumour

5.3 months

8.4 months

Overall Survival (OS)

Measures ability of a drug to
prolong life

12.7 months

17.7 months

ASCO Conference

The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting is one of the premier scientific conferences in the world for research and treatment of cancer. It is typically attended by more than 30,000 clinicians, researchers, industry executives, and patient advocates. In 2020, the meeting is being conducted in a virtual format due to the ongoing COVID-19 pandemic.

The Kazia data is presented in Abstract 2550 (NCT03522298). In addition to Kazia’s paxalisib poster, abstracts are being presented by the Global Coalition for Adaptive Research on the GBM AGILE clinical trial (Abstract TPS2579; NCT03970447), and by the Alliance for Clinical Trials in Oncology on their genomically-guided study in brain metastases (Abstract TPS2573; NCT03994796), in which paxalisib is one of three participating drug candidates.

The Kazia poster is available for download via the Kazia website at View Source

Background

The reported overall survival (OS) figure of 17.7 months represents a strong signal of clinical efficacy. The existing, FDA-approved standard of care, temozolomide, is associated with an OS of 12.7 months in this patient population[1]. Comparison between different studies is always imprecise, but the magnitude of the numerical difference provides powerful evidence that treatment with paxalisib may extend life in this patient group.

The reported progression-free survival (PFS) figure of 8.4 months compares favourably with the PFS of 5.3 months that is associated with temozolomide in this patient population. In April 2020, Kazia reported an interim analysis showing a PFS of 8.5 months in the overall study population (n=30). This poster only reports the first stage of the study (n=9), and the figure in this part of the study was 8.4 months.

Before losing patent protection, temozolomide achieved peak sales in excess of US$ 1 billion per annum, which provides an indication of the commercial opportunity associated with a new treatment for glioblastoma.

The Kazia study is being conducted in newly-diagnosed glioblastoma patients, following surgery and radiotherapy. Only those patients with an unmethylated MGMT promotor have been recruited. This genetic marker renders patients effectively resistant to temozolomide and is present in approximately two-thirds of patients.

Thirty patients were enrolled to this study, comprising 9 in Stage 1 , and 21 in Stage 2. Data reported here are provisional figures from Stage 1 (for OS) and from the entire study population (for PFS), but may change as ongoing patients proceed through the study. The study has been conducted at leading centers of excellence in the United States.

The safety of paxalisib remained broadly consistent with prior experience, with hyperglycaemia (raised blood sugar), oral mucositis (mouth ulcers), and low-grade rash among the most common drug-related toxicities.

In addition to this phase II study in glioblastoma, four other studies are underway with paxalisib in different forms of brain cancer, and it is anticipated that several of these will provide initial efficacy data during CY 2020.

Investors are referred to Kazia’s announcement of 7 April 2020 for further discussion of these results.

Next Steps

The phase II study remains ongoing, with approximately half of the total enrolled patient population still receiving drug at the time of analysis and a number of additional patients still in follow-up. Kazia expects to complete the study in 1H CY2021.

Kazia had previously had an abstract accepted the AACR (Free AACR Whitepaper) Annual Meeting, which had originally been scheduled for April 2020. This meeting has now been rescheduled to several virtual meetings, and Kazia will present a poster at the ‘AACR Virtual Annual Meeting II’ on 22-24 June 2020.