Swiss biotechs in dispute with regulators

Pharvaris develops drug candidates for a rare and potentially life-threatening genetic condition called hereditary angioedema (HAE) and related indications. On Monday the Zug-based company announced that the U.S. Food and Drug Administration (FDA) verbally informed Pharvaris that, based on its review of nonclinical data, the agency is placing a clinical hold on the clinical trials of PHA121 in the U.S. under two Pharvaris Investigational New Drug (IND) applications for the treatment of HAE. The FDA indicated it will provide a formal clinical hold letter to Pharvaris in approximately 30 days. The company plans to provide additional updates following interactions with the FDA. Shares of the Nasdaq-listed company plunged by around 40% in the wake of the announcement.

“We are fully committed to working closely with the FDA to address the agency’s concerns,” said Berndt Modig, chief executive officer of Pharvaris. “Pharvaris remains dedicated to providing new therapeutic choices for the treatment of HAE and is working diligently to bring PHA121 to people living with HAE.”

ObsEva faces de-listing from Nasdaq

ObsEva SA, a biopharmaceutical company developing novel therapies to improve women’s reproductive health, announced that on August 19, 2022 it received a notification letter from The Nasdaq Stock Market (“Nasdaq”) advising the Company that it was not in compliance with Listing Rule 5450(b)(1)(A) requiring companies listed on the Nasdaq Global Select Market  to maintain a minimum of $10,000,000 in stockholders’ equity for continued listing. 

The notification letter from Nasdaq was based on the Company’s Form 6-K dated August 17, 2022, disclosing financial information for the period ended June 30, 2022, which reported shareholders’ equity of ($2,103,000).  Under Nasdaq rules the Company would normally have 45 calendar days to submit a plan to regain compliance. However, Nasdaq has determined to shorten the response time for the Company to submit its plan pursuant to its discretionary authority set forth in Listing Rule 5101. The Company has until August 29, 2022 to submit a plan to regain compliance, and the Company intends to submit a plan by such date.

If the plan is accepted, which there can be no assurance, the Company may be granted an extension of up to 180 calendar days from August 19, 2022 to regain compliance with this particular rule.  If Nasdaq determines that the Company’s plan is not sufficient to achieve and sustain compliance, it may provide written notice to the Company that its securities will be subject to delisting.  At that time, the Company may appeal the delisting determination to a Nasdaq Hearings Panel. In addition to Nasdaq ObsEva is listed at the Swiss Stock Exchange.

SIX sanction proposal against Evolva 

SIX Exchange Regulation AG (SER) has concluded that the 2019 and 2020 IFRS annual financial statements of Evolva Holding SA contain material misstatements. For this reason SER has submitted a request for a sanction to the Sanctions Commission against Evolva Holding SA on 22 August 2022. The alleged deficiencies refer to the goodwill impairment tests used for the 2019 and 2020 IFRS annual financial statements as well as the related disclosures.

Evolva is convinced that key allegations do not uphold and that potential deficiencies do not have a material impact. Evolva CEO Christian Wichert, who has joined the company in February this year, comments: “While the primary focus of the new leadership team is on leveraging the ongoing positive business momentum, boosting commercial performance and bringing Evolva to the next level, we are also committed to transparency and closing with the past. Thus, we are fully collaborating with SER and continuously strengthening our internal processes and rules.”

(Press release / SK)