On June 9, 2022 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Global Select Market: DBVT), a clinical-stage biopharmaceutical company, reported an aggregate $194 million private investment in public equity (PIPE) financing (corresponding to €181 million on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022) from the sale of 32,855,669 ordinary shares, as well as pre-funded warrants to purchase up to 28,276,331 ordinary shares (Press release, DBV Technologies, JUN 9, 2022, View Source [SID1234615927]). The ordinary shares will be sold to the purchasers at a price per ordinary share of €3.00 (corresponding to $3.22), and the pre-funded warrants will be sold to the purchasers at a pre-funded price of €2.90 (corresponding to $3.11) per pre-funded warrant, which equals the per share price for the ordinary shares less the remaining €0.10 exercise price for each such pre-funded warrant. Gross proceeds from the PIPE financing total approximately $194 million (corresponding to €181 million), before deducting private placement expenses. The closing of the PIPE financing is subject to customary closing conditions and is expected to close on June 13, 2022.

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The ordinary shares, including the ordinary shares issuable upon exercise of the pre-funded warrants, have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the ordinary shares, including the ordinary shares underlying the pre-funded warrants.

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

Goldman Sachs Bank Europe SE and SVB Securities LLC acted as placement agents in the private placement.

Braidwell LP, funds advised by Baker Bros. Advisors LP and BpiFrance Participations SA, each a current shareholder of the Company, and Venrock Healthcare Capital Partners, have subscribed respectively an aggregate of $11 million, $38 million, $8 million and $30 million of ordinary shares. Braidwell LP, Baker Bros. Advisors LP and Venrock Healthcare Capital Partners have subscribed respectively an aggregate of $19 million, $41 million, $28 million of pre-funded warrants. Other investors in the private placement include Fairmount, RA Capital Management and Vivo Capital. The price of the ordinary shares and the price of the pre-funded warrants was equal to the average of the closing prices of the Company’s ordinary shares on Euronext Paris over the five (5) trading days prior to the launch of the global offering (i.e. June 8th, 7th, 6th, 3rd and 2nd), with a premium of 0.8%. The new ordinary shares and pre-funded warrants will be issued through a capital increase without shareholders’ pre-emptive rights by means of a reserved offering to specific categories of investors under the provision of Article L. 225-138 of the French Commercial Code and pursuant to the decisions of the Chief Executive Officer dated June 9, 2022 and the Company’s Board of Directors (Conseil d’Administration) dated June 8, 2022, in accordance with the delegations granted pursuant to resolution 18 adopted at the 2022 ordinary and extraordinary meeting of the Company’s shareholders (Assemblée Générale Mixte) held on May 12, 2022. The representatives of Baker Bros. Advisors LP and BpiFrance Participations SA to the Company’s Board of Directors (Conseil d’Administration) did not take part in the vote on the decisions at the meeting of the Board of Directors held on June 8, 2022.

Application will be made to list the new ordinary shares to be issued pursuant to the PIPE financing on the regulated market of Euronext Paris pursuant to a listing prospectus subject to the approval by the Autorité des Marchés Financiers ("AMF") and comprising (i) the 2021 universal registration document filed with the AMF on March 9, 2022 (document d’enregistrement universel 2021) under number D. 22-0081, as completed by an amendment to the 2021 universal registration document to be filed with the AMF on June 9, 2022 and (ii) a Securities Note (Note

d’opération), including (iii) a summary of the prospectus. Copies of the Company’s 2021 universal registration document, as amended, will be available free of charge at the Company’s head office located at 177-181 avenue Pierre Brossolette – 92120 Montrouge – France. The listing prospectus will be published on the AMF’s website at www.amf-france.org.

On June 9, 2022 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported the company has entered into an exclusive collaboration with Pint Pharma GmbH to register and promote ORLADEYO (berotralstat) in the pan-Latin America (LATAM) region (Press release, BioCryst Pharmaceuticals, JUN 9, 2022, View Source [SID1234615812]).

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"We are pleased to join forces with Pint Pharma to bring our oral, once-daily therapy to hereditary angioedema patients in LATAM who are in need of a new treatment option. Pint Pharma is the ideal partner for BioCryst based on the team’s deep experience in rare diseases that spans multiple aspects of commercialization and their established network across this important region," said Charlie Gayer, chief commercial officer of BioCryst.

"Our partnership with BioCryst is significant for Pint Pharma given the critical unmet need among HAE patients in LATAM who are seeking an innovative treatment option for this serious disease. ORLADEYO has successfully launched in multiple markets across the globe, and we are privileged to leverage our expertise to support BioCryst in introducing this prophylactic therapy to the region," said David Munoz, chief executive officer and co-founder of Pint Pharma.

Under the terms of the agreement, Pint Pharma will be responsible for obtaining and maintaining all marketing authorizations and for commercializing ORLADEYO in the pan-LATAM region.

Pint Pharma is an Austria-based pharmaceutical company that has extensive experience developing, registering and commercializing rare disease and specialty treatments throughout Latin America and Europe.

About ORLADEYO (berotralstat)
ORLADEYO (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.

U.S. Indication and Important Safety Information

INDICATION
ORLADEYO (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.

Limitations of use
The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation.

IMPORTANT SAFETY INFORMATION

An increase in QT prolongation was observed at dosages higher than the recommended 150 mg once-daily dosage and was concentration dependent.

The most common adverse reactions (≥10% and higher than placebo) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.

A reduced dosage of 110 mg taken orally once daily with food is recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) and in patients taking chronically administered P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine).

Berotralstat is a substrate of P-gp and BCRP. P-gp inducers (eg, rifampin, St. John’s wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. The use of P-gp inducers is not recommended with ORLADEYO.

ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 or CYP3A4, appropriate monitoring and dose titration is recommended. ORLADEYO at a dose of 300 mg is a P-gp inhibitor. Appropriate monitoring and dose titration is recommended for P-gp substrates (eg, digoxin) when coadministering with ORLADEYO.

The safety and effectiveness of ORLADEYO in pediatric patients <12 years of age have not been established.

There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production.

On June 9, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported that China’s National Medical Products Administration (NMPA) has approved Trodelvy (sacituzumab govitecan or SG) 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, JUN 9, 2022, View Source [SID1234615844]). This is the first drug that Everest has obtained New Drug Application (NDA) approval to launch in China. In May 2021, the NMPA accepted Everest’s NDA for Trodelvy with Priority Review designation.

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"We are extremely excited for Trodelvy’s NDA approval in China as Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate. This marks a significant milestone for Everest with our first drug approved in our home market, where we hope to continue to bring innovative therapies to people with urgent medical needs," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "We want to extend our gratitude to the NMPA and the Center for Drug Evaluation for the Priority Review and fast approval."

"The NMPA approval of Trodelvy will provide an important and new treatment option for Chinese women with metastatic triple-negative breast cancer – a very aggressive and challenging to treat form of the disease. We would like to thank the investigators and patients who participated in the clinical trials for making this possible," said Yang Shi, Chief Medical Officer for Oncology/Immunology at Everest Medicines. "We will continue to work with our partner, Gilead, to advance clinical research of Trodelvy across multiple tumor types as well as earlier lines of therapy."

In November 2021, Everest announced topline results from its Phase 2b EVER-132-001 study of Trodelvy in 80 people, which met its primary endpoint with a 38.8% overall response rate (ORR). The results were consistent with those from the global Phase 3 ASCENT study, thus showing similar efficacy and safety in the Chinese population.

"Patients with triple-negative breast cancer are in urgent need of new and effective treatment options. I have witnessed the introduction of sacituzumab govitecan (Trodelvy) into China, and led the registrational clinical study in the nation," said Professor Binghe Xu, academician of the Chinese Academy of Engineering and director of the National New Drug (Anti-Cancer) Clinical Research Centre who is the principal investigator of Trodelvy’s registrational study in China. "I am glad that sacituzumab govitecan has shown similar positive results in the domestic clinical study as those from the global trial. As a clinician, I hope that this new drug can reach patients as early as possible to save more lives."

"There is a significant unmet need among metastatic triple-negative breast cancer patients in China who are waiting eagerly for a better treatment option to extend their lives," said Kevin Guo, Chief Commercial Officer at Everest Medicines. "With the Trodelvy approval in China, we will rapidly expand our sales team to launch this novel product in the fourth quarter this year and bring it to as many hospitals and patients in China as possible."

In addition to mainland China and Singapore where Trodelvy has been approved, Everest is closely coordinating with regulatory bodies in South Korea, Taiwan and Hong Kong to review its applications for Trodelvy 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.

In December 2021, the Ministry of Food and Drug Safety (MFDS) of South Korea accepted a New Drug Application (NDA) for Trodelvy. Trodelvy was previously granted Fast Track Designation and Orphan Drug Designation in South Korea.
In December 2021, the Taiwan Food and Drug Administration accepted submission of NDA for Trodelvy. Trodelvy was previously granted Pediatric and Rare Severe Disease Priority Review Designation in Taiwan.
In January 2022, the Health Sciences Authority of Singapore approved the Company’s NDA for Trodelvy for the treatment of second-line and later-line metastatic TNBC.
In March 2022, an NDA was submitted to the Department of Health, the Hong Kong Special Administrative Region, China, for Trodelvy for the treatment of second-line metastatic TNBC.
Conference Call Information

A live conference call will be hosted on June 13, 2022 at 8:00 AM Beijing Time (June 12, 2022 at 8:00 PM U.S. Eastern Time).

The live webcast of the conference call will be available at View Source

To ask questions during the Q&A section, participants shall access the call by dialing the following numbers:

A replay will be available shortly after the call and can be accessed by visiting the Company’s website at View Source

About Triple-Negative Breast Cancer (TNBC)

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. 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 do not have estrogen and progesterone hormone receptors and have limited or no human epidermal growth factor receptor 2 (HER2) expression. Due to the nature of TNBC, effective treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.

About Trodelvy (Sacituzumab Govitecan)

Trodelvy is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment.

Trodelvy is approved in more than 35 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of 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. Trodelvy is also approved in the U.S. under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

Trodelvy is also being developed for potential investigational use in other TNBC and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, including hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer, metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize Trodelvy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, Trodelvy was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer and was also included in the updated 2022 Guidelines for Breast Cancer Diagnosis and Treatment of the Chinese Society of Clinical Oncology in April.

*The TRODELVY trademark is used under license from Gilead Sciences, Inc.

On June 9, 2022 Anaveon, a clinical-stage immuno-oncology company, reported that the U.S. Food and Drug Administration (FDA) has cleared the IND application for ANV419-101, a Phase I/II mono treatment dose confirmation and combination dose-finding, global study, in patients with advanced cutaneous melanoma (Press release, Anaveon, JUN 9, 2022, View Source [SID1234616639]).

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ANV419, a potent IL-2Rbg agonist, preferentially proliferates CD8 and NK cells over regulatory T cells. The safety profile seen to date will allow for the administration of doses inducing maximal pharmacodynamic effects. The most frequent drug related AEs seen in an ongoing trial include mild Grade 1 chills and low-grade fever a few hours after dosing, which resolved with antipyretic treatment.

"We are excited to bring ANV419 to patients who are most likely to benefit from a truly IL-2Rbg-selective high-dose IL-2 approach," said Christoph Bucher, Chief Medical Officer at Anaveon. "We look forward to expanding our clinical program to the US and maximizing the therapeutic potential of ANV419 for patients suffering from cancer."

About the Phase I/II Clinical Trial

The clinical trial is a Phase I/II multiple arm, open-label study in patients with unresectable or metastatic cutaneous melanoma. The study will be a sequential, multi-part clinical trial to evaluate the safety and efficacy of different monotherapy doses of ANV419, as well as in combination with anti-PD1 or anti-CTLA4. Up to 130 patients will be enrolled in the clinical trial.

On June 9, 2022 Forbion, a leading European life sciences venture capital firm, reported the first €470 million (USD 500 million) close of its Forbion Growth Opportunities Fund II ("Forbion Growth"), focused on investing in late-stage European life sciences companies, exceeding its €450 million target size (Press release, Forbion Capital Partners, JUN 9, 2022, View Source [SID1234615813]).

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This new Growth Opportunities Fund has attracted several new institutional investors, including pension funds PME and PMT, the Ewing Marion Kauffman Foundation and Reggeborgh, who join returning investors Pantheon, Wealth Management Partners and Eli Lilly and Company.

The second Forbion Growth Opportunities Fund will continue to invest in mostly European, later-stage biopharma companies, developing novel therapies for areas of high medical need. The Fund will target this market segment with three proven strategies: providing private growth capital for mature clinical development-stage assets, furnishing pre-IPO funding to companies pursuing a public listing in the near-term, and injecting capital and hands-on capabilities to under-valued public companies. In these financings, Forbion Growth Opportunities II aims to take leading positions with investment sizes of up to €70 million per deal. The team’s goal is to build a portfolio of 15 such investments in the most promising late-stage European life sciences companies.

Forbion expects to reach its €600 million hard cap, completing the raising of Forbion Growth Opportunities Fund II over the summer.

Sander Slootweg, Managing Partner and co-founder of Forbion said: "The European market for late stage, private life sciences investments is large and remains significantly underserved. The increase in the number of institutional investors committing to the Forbion Growth Opportunities Fund II is a testament to our successful track record in investing in late clinical stage life sciences companies. A recent example is the sale of Gyroscope Therapeutics to Novartis for a total consideration of $ 1.5 billion earlier this year, after a mere nine month hold period."

Dirk Kersten, General Partner, added: "In the past two years, we have successfully deployed Forbion Growth Opportunities Fund I, providing growth capital to a selected number of high-quality European life sciences companies. Forbion Growth has built the most experienced and sizeable team in Europe focusing on the late-stage segment, and is ready to continue investing in ambitious life sciences companies looking to accelerate their growth. We are therefore very excited to announce this substantial first close of Forbion Growth Opportunities Fund II, and look forward to the final close of the fund later this year."