On September 16, 2022 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported that it will effect a 1-for-14 reverse stock split of its outstanding common stock (Press release, Sonnet BioTherapeutics, SEP 16, 2022, View Source [SID1234619615]). This will be effective for trading purposes as of the commencement of trading on Monday, September 19, 2022.

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The reverse stock split is intended to increase the per share trading price of Sonnet’s common stock to satisfy the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market (Rule 5550(a)(2)). Sonnet’s common stock will continue to trade on The Nasdaq Capital Market under the symbol "SONN" and under a new CUSIP number, 83548R204. As a result of the reverse stock split, every fourteen pre-split shares of common stock outstanding will become one share of common stock. The par value of the Company’s common stock will remain unchanged at $0.0001 per share after the reverse stock split. The reverse stock split will not change the authorized number of shares of the Company’s common stock. The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse stock split results in some stockholders owning a fractional share. No fractional shares will be issued in connection with the reverse split. Stockholders who would otherwise be entitled to receive a fractional share will instead receive a cash payment based on the average closing price of the Company’s common stock on the five (5) consecutive days leading up to the effective date of the reverse split. The reverse split will also apply to common stock issuable upon the exercise of Sonnet’s outstanding warrants and stock options, with a proportionate adjustment to the exercise prices thereof, and under the Company’s equity incentive plans.

The reverse stock split will reduce the number of shares of common stock issued and outstanding from approximately 69.6 million to approximately 5.0 million.

On September 15, 2022, the stockholders of the Company approved the reverse stock split and gave the Company’s board of directors discretionary authority to select a ratio for the split ranging from 1-for-2 to 1-for-40. The board of directors approved the reverse stock split at a ratio of 1-for-14 on September 15, 2022.

Securities Transfer Corporation is acting as the exchange agent and transfer agent for the reverse stock split. Stockholders holding their shares in book-entry form or in brokerage accounts need not take any action in connection with the reverse stock split. Beneficial holders are encouraged to contact their bank, broker or custodian with any procedural questions.

On September 16, 2022 Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, reported that the company has withdrawn the Marketing Authorization Application (MAA) for the company’s Herceptin Biosimilar, HD201(Tuznue), submitted to the European Medicines Agency (EMA) (Press release, Prestige BioPharma, SEP 16, 2022, View Source [SID1234619613]). The company will reapply to EMA for the MAA with supplementation of data and analysis.

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On May 23, the company requested re-examination on the MAA for the HD201, after receiving a negative opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on May 19. Despite the evidence of the analytical comparability and biological similarity proven through clinical trials of HD201, CHMP delivered a negative opinion due to disparity in the range of acceptance for the criteria of analytical comparability between the clinical testing batch and commercial production batch of HD201.

During re-examination, it was reported that the newly assigned main rapporteur suggested a positive opinion. Nonetheless, it couldn’t overturn CHMP’s range of acceptance for the criteria of analytical comparability. Based on long-term marketing strategy, the company decided to voluntarily withdraw its application and plans to reapply after supplementing data through additional tests and analysis to meet CHMP’s criteria of analytical comparability.

Prestige Biopharma’s HD201 is a proposed biosimilar to Roche’s Herceptin (trastuzumab) and can be prescribed for the treatment of HER2 positive breast and metastatic gastric cancer. Trastuzumab targets human epidermal growth factor 2 (HER2). In some types of cancer cells, HER2 is overexpressed and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.

Currently, the MAA for HD201 is under review by Health Canada and Korea Ministry of Food and Drug Safety and will be submitted to the US Food and Drug Administration (FDA) by the end of this year. At the same time, Prestige Biopharma plans to focus on the reapplication process of the MAA to EMA for HD201 and prepare for the global market entry based on partnerships with global biopharmaceuticals.
The internal and external expert advisory panel of Prestige Biopharma stated: "The company’s confidence is based on the excellent pharmaceutical quality of HD201 proven through clinical studies and multiple analysis. Through the re-examination, we received positive opinion by the main rapporteur, which is encouraging. We will do our best to obtain approval for HD201 in US and Europe without any doubt and provide patients with better access to treatments."

On September 16, 2022 NH TherAguix ("NHT"), reported the arrival of Dr. Olivier de Beaumont as Chief Medical Officer from September 2022. – Sept. 09, 2022 (Press release, NH TherAguix, SEP 16, 2022, View Source [SID1234619612]).

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On September 16, 2022 ADC Therapeutics SA (NYSE: ADCT) and Swedish Orphan Biovitrum AB (Sobi) reported the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorization of ZYNLONTA (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Press release, ADC Therapeutics, SEP 16, 2022, View Source [SID1234619608]). The positive opinion from the CHMP is now referred to the European Commission for an approval decision.

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Earlier this year, ADC Therapeutics announced an exclusive license agreement with Sobi to develop and commercialize ZYNLONTA for all hematologic and solid tumor indications in Europe and select international territories.

The opinion is based on data from LOTIS-2, a large (n=145) Phase 2 multinational, single-arm clinical trial of ZYNLONTA for the treatment of adult patients with relapsed or refractory DLBCL following two or more prior lines of systemic therapy. In April 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval of ZYNLONTA as the first CD19-targeted antibody drug conjugate (ADC) as a single-agent treatment for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. In September 2021, the European Commission granted Orphan Drug Designation to ZYNLONTA for the treatment of DLBCL.

ADC Therapeutics has an exclusive license agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications in Japan. In addition, Overland ADCT BioPharma, a joint venture formed by Overland Pharmaceuticals and ADC Therapeutics, is working to develop and commercialize ZYNLONTA in greater China and Singapore. Overland ADCT BioPharma is now conducting a registrational pivotal Phase 2 clinical trial of ZYNLONTA in relapsed or refractory DLBCL in China.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On September 16, 2022 Servier reported that it has launched an initiative with California Life Sciences Association (CLSA) to support an early-stage life sciences company developing innovative approaches in the therapeutic areas developed by the Group: oncology; auto-immune diseases ; genetically driven neurodegenerative and movement disorders (Press release, Servier, SEP 16, 2022, View Source [SID1234619606])

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"This collaboration offers a great opportunity for California-based innovators and disruptors in earlier stages to get on the radar of a potential licensing or exit partner by applying to this call," said Sibylle Hauser, executive director of Innovation Services at CLS.

"Our partnerships’ philosophy is about accessing innovative new therapeutic solutions to meet patient needs," said Christophe Thurieau, executive director of Servier Research. "Starting a collaboration with California Life Sciences, a leading life science organization in the US, is definitely inspiring. Networked innovation without barriers is crucial for serving patients’ unmet needs even more effectively and rapidly. Agile methods to accelerate R&D programs are based on synergies and teamwork."

Among the 23 applications, Servier has awarded the Servier FAST Discovery Award to F5 Therapeutics. This start up sets up a technological platform to develop First-in-Class small molecules for the treatment of diseases with high unmet medical need notably in oncology and immunology.

Beyond supporting innovation, this initiative is also the opportunity for Servier, to reinforce its interaction with innovative players in the US and more specifically on the West coast and to set up long term relationships with F5 Therapeutics to boost innovation for the benefit of patients.

*Servier favors open collaboration to accelerate the development of therapeutic solutions for the benefit of patients. Convinced that work and ongoing dialogue between healthcare players is the best framework for rapid innovation focused on patients’ needs, Servier continues to expand and diversify its network of R&D partners.