CytoDyn Announces Leadership Transition Plan to Support Regulatory Approval and Commercialization of Leronlimab

On January 25, 2022 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported a leadership transition plan (Press release, CytoDyn, JAN 25, 2022, View Source [SID1234607497]). Effective immediately, Antonio Migliarese, currently CytoDyn’s Chief Financial Officer, has been appointed interim President. The Board of Directors terminated the employment of Nader Z. Pourhassan, Ph.D., as President and CEO of the Company and he is no longer a member of the Board of Directors, effective January 24, 2022. The rest of CytoDyn’s executive team is continuing with the Company and is united in their commitment to advance the Company’s objectives.

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A committee of three Board members has been appointed to initiate the search for a new permanent CEO, with a focus on identifying a candidate possessing the requisite pharmaceutical industry experience to enhance the Company’s efforts to achieve regulatory approval and commercialization of leronlimab. Mr. Migliarese will also continue in his role as CFO of the Company during this interim period.

Scott A. Kelly, M.D, Chairman of the Board and Chief Medical Officer of CytoDyn, stated, "Now is the right time for the next phase of CytoDyn’s evolution, as we focus on continuing the clinical progress of leronlimab and ultimately securing regulatory approval and commercialization. Our Board is fully focused on identifying the best possible candidate to lead the Company forward, and we are focusing our search on finding an individual with the appropriate experience and skillsets to maximize the potential of leronlimab for patients, partners, and shareholders. In addition, in an effort to enhance the Board’s independence, I have elected to step down as Chairman of the Board but will remain on the Board of Directors. The Board has elected Tanya Durkee Urbach, an independent director who has experience in corporate governance, corporate finance, business growth and securities litigation, compliance and regulatory issues, as Chairman of the Board. We thank Dr. Pourhassan for his vision and passion for developing leronlimab into a platform molecule with the potential for multiple therapeutic indications."

CytoDyn will keep shareholders and stakeholders informed on the Company’s progress in implementing its leadership transition plan as and when appropriate.

Johnson & Johnson Reports Q4 and Full-Year 2021 Results

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Sigyn Therapeutics to Present at the Bullseye Small Cap Virtual Investor Conference

On January 25, 2022 Sigyn Therapeutics, Inc. (OTC Markets:"SIGY"), a medical technology company focused on the treatment of pathogen-related conditions that precipitate sepsis, reported that its Chairman and CEO, Jim Joyce, will give a corporate presentation at the upcoming Bullseye Small Cap Virtual Investor Conference to be held on January 27th and 28th, 2022 (Press release, Sigyn Therapeutics, JAN 25, 2022, View Source [SID1234607420]).

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Mr. Joyce’s presentation is scheduled to begin at 3:30 pm eastern on January 27th, 2022. To virtually attend, register at:

View Source

Sigyn management will also be available for online 1×1 meetings with the members of the investment community. To schedule a meeting please visit: View Source or email [email protected].

Mr. Joyce’s presentation will include an update on Sigyn Therapy, a multi-function blood purification technology being advanced to treat a broad-spectrum of pathogen related conditions that precipitate sepsis.

Additional information on Sigyn Therapy, including recent media coverage, can be accessed through the links below:

January 11, 2022 – "Sigyn Therapeutics: Calming and Preventing the Cytokine Storm"

View Source

January 17, 2022 – "A Perfect Storm of Superbugs"

View Source

January 20, 2022 – "How COVID-19 Has Spurred a Shift to Broad-Spectrum Countermeasures Against Viruses"

View Source

Merus Appoints Shannon Campbell as Chief Commercial Officer and Regains Worldwide Rights to MCLA-145

On January 25, 2022 – Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the appointment of Shannon Campbell as Executive Vice President & Chief Commercial Officer (Press release, Merus, JAN 25, 2022, View Source [SID1234607410]). Ms. Campbell is an accomplished healthcare leader with demonstrated success leading commercial businesses across a range of specialty markets, including oncology.

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"Shannon will be instrumental in advancing Merus’ mission to become a commercial-stage company, further advancing the strategy for our lead clinical program, zenocutuzumab for neuregulin 1 fusion cancer and developing our commercial approach for our pipeline of innovative multispecific antibody product candidates," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "Her leadership and depth of experience in launching products, managing partnerships, and delivering sustained performance in highly competitive oncology markets will be a great asset to our organization."

Ms. Campbell will join Merus as Executive Vice President & Chief Commercial Officer in February to lead the commercial strategy for the most advanced clinical candidate, zenocutuzumab (Zeno), as well as Merus’ robust pipeline of multispecific product candidates in development. This includes petosemtamab (MCLA-158), currently under investigation in second-line head and neck squamous cell carcinoma; MCLA-145, under investigation for solid tumors; and MCLA-129, under investigation for patients with lung and other solid tumors, particularly those that do not respond to EGFR inhibitors. Merus holds global rights to all four clinical candidates, apart from MCLA-129, for which Merus licensed to Betta Pharmaceuticals the exclusive right to develop and commercialize in China.

Ms. Campbell brings over 25 years of pharmaceutical commercialization experience and joins Merus from Novartis Pharmaceuticals, where she led Novartis’s U.S. Oncology Solid Tumor Franchise and was responsible for a broad portfolio of therapies in oncology and rare diseases. Prior to Novartis, Ms. Campbell was with Bayer HealthCare Pharmaceuticals, where she was instrumental in helping to build, launch and lead Bayer’s U.S. Oncology business.

"I am excited to join Merus at this pivotal time," said Ms. Campbell. "The Merus pipeline of clinical-stage assets has the potential to offer meaningful benefit to patients, and I look forward to building and leading the commercial strategy for these programs."

Merus also announced today that Incyte (Nasdaq: INCY) has elected to opt-out of its ex-U.S. development of MCLA-145, restoring full global rights to Merus. MCLA-145 is currently enrolling a global, phase 1, open-label, single-agent clinical trial evaluating MCLA-145 in patients with solid tumors. The trial consists of a dose escalation phase, followed by a planned dose expansion phase. Merus is also planning to evaluate the combination of MCLA-145 with a PD-1 blocking antibody.

"Regaining worldwide rights to MCLA-145 opens up new possibilities for Merus," said Dr. Lundberg. "We remain committed to continuing the development of MCLA-145 to explore the potential of this compound as monotherapy, as well as in combination, to address the high unmet medical need for patients with solid tumors. We look forward to the further progress and continued success of our other joint projects in research and development with Incyte under this collaboration."

Under the terms of a 2017 Collaboration and License Agreement ("Agreement") between Merus and Incyte, Incyte received ex-U.S. rights to MCLA-145. Incyte’s opt-out of ex-U.S. rights to MCLA-145 provides Merus the exclusive right to develop and commercialize potential MCLA-145 products globally. As part of the Agreement, Incyte will continue to support the program for a limited time while ex-U.S. activities are transitioned to Merus, and Incyte will also retain a right to a residual royalty of up to 4% on sales of future commercialization of MCLA-145, if approved.

Additionally, per the Agreement, the parties will continue to collaborate on the development and commercialization of up to ten bispecific or monospecific antibody programs. Merus also has the option to co-fund development of product candidates arising from two programs. For any program for which Merus exercises its co-development option, Merus would be responsible for 35 percent of global development costs in exchange for a 50 percent share of U.S. profits and losses and tiered royalties ranging from 6 to 10 percent on ex-U.S. sales by Incyte for these programs. Merus also has the right to elect to provide up to 50 percent of detailing activities for product candidates arising from one of these programs in the U.S.

Checkpoint Therapeutics to Participate in the B. Riley Securities’ Virtual Oncology Conference

On January 25, 2022 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that James Oliviero, President and Chief Executive Officer, will participate in a fireside chat hosted by Justin Walsh, Equity Research Analyst (Biotechnology), at the B. Riley Securities’ Virtual Oncology Conference, taking place on Thursday, January 27, 2022, at 11:00 a.m. EST (Press release, Checkpoint Therapeutics, JAN 25, 2022, View Source [SID1234607409]). Checkpoint management will also participate in one-on-one meetings during the conference.

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A live webcast of the fireside chat will be available on the IR Calendar page under News & Events, located within the Investors section of Checkpoint’s website, View Source, for approximately 30 days following the meeting.