PDL BioPharma to Complete Spin-Off of LENSAR, Inc. on October 1, 2020

On September 10, 2020 PDL BioPharma, Inc. ("PDL" or the "Company") (Nasdaq: PDLI) reported that its Board of Directors has approved the separation of LENSAR, Inc. ("LENSAR"), a majority owned subsidiary of PDL, from PDL in the form of a dividend involving the distribution of all outstanding shares of LENSAR common stock owned by PDL to holders of PDL common stock (Press release, PDL BioPharma, SEP 10, 2020, View Source [SID1234565158]). Under the terms of the distribution:

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LENSAR common stock is expected to be distributed on October 1, 2020 to PDL stockholders of record as of 5:00 p.m. Eastern Time on September 22, 2020, the record date for the distribution.
PDL stockholders will receive 0.075879 shares of LENSAR common stock for every one share of PDL common stock held by such holders (after giving effect to a one-for-nine reverse split of LENSAR’s common stock effected on September 9, 2020).
"The decision by the PDL Board of Directors to spin off LENSAR is the result of the comprehensive strategic process conducted in partnership with our financial advisors at SVB Leerink," commented Dominique Monnet, PDL’s President and Chief Executive Officer. "We are excited about LENSAR’s growth potential as an innovation leader in cataract surgery and its opportunities as a well-capitalized, publicly traded company."

"PDL has been an incredibly supportive parent to LENSAR at a critical time during the execution of our growth strategy," said Nicholas T. Curtis, LENSAR’s Chief Executive Officer. "We believe the decision to fund the development of our GEN2 device ALLY will prove to have long-term impact on the way cataract surgery is thought of and performed globally. We are excited to move forward and take the company to the next level as an independent company with the aspiration of becoming the technology leader in both the premium and conventional cataract surgery markets."

Immediately after the distribution is completed, LENSAR will be an independent, publicly traded company, and "regular-way" trading of LENSAR’s common stock will begin the first trading day after the completion of the distribution. The LENSAR stock is expected to be listed on the Nasdaq Capital Market ("Nasdaq") under the symbol "LNSR."

SVB Leerink is serving as financial advisor to PDL in connection with the spin-off of LENSAR.

Distribution of LENSAR Shares to PDL Stockholders

As stated above, PDL stockholders of record as of 5:00 p.m., Eastern time on September 22, 2020 (the "record date") will be entitled to receive 0.075879 shares of LENSAR common stock for every one share of PDL common stock held by such holders.

No action is required by PDL stockholders to receive the shares of LENSAR common stock in the distribution. PDL stockholders will not be required to pay for the LENSAR shares or to surrender any shares of PDL stock. The distribution will be made in book-entry form.

Fractional shares of LENSAR common stock will not be distributed. Fractional shares of LENSAR common stock that would otherwise be distributed to PDL stockholders will be aggregated and sold in the public market by the transfer agent. The aggregate net proceeds of these sales will be distributed ratably as cash payments to the stockholders who would otherwise have received fractional interests. PDL stockholders should consult their tax advisors with respect to U.S. federal, state, local and non-U.S. tax consequences of the distribution.

Trading of PDL and LENSAR Common Stock

There is currently no market for LENSAR’s common stock. LENSAR expects its common stock to begin trading on a "when-issued" basis shortly before the September 22, 2020 record date under the ticker "[LNSRV]." "When-issued" trading of LENSAR common stock will continue until the distribution occurs. LENSAR "when-issued" trades will settle after the distribution date with newly issued shares of LENSAR.

Beginning shortly before the September 22, 2020 record date and continuing through the distribution date, it is expected that there will be two ways to trade PDL common stock – either with or without the right to receive shares of LENSAR common stock in the distribution. Stockholders who sell their shares of PDL common stock in the "regular-way" market (that is, the normal trading market on the Nasdaq Stock Market LLC under the symbol "PDLI") after the record date and on or prior to the distribution date will be selling their right to receive shares of LENSAR common stock in connection with the distribution. It is anticipated that stockholders may also trade their shares of PDL common stock ex-distribution (that is, without the right to receive the shares of LENSAR common stock in the distribution) during that period under the symbol "[PDLIV]."

Investors are encouraged to consult with their financial advisers regarding the specific implications of buying or selling PDL or LENSAR common stock prior to the distribution date.

The completion of the distribution is subject to the satisfaction or waiver of a number of conditions, including, among the others described in the Information Statement included in the Form 10 filed by LENSAR, the declaration by the SEC of the effectiveness of the Form 10, the LENSAR common stock being accepted for listing on the Nasdaq exchange and final approval by the PDL Board of Directors that the distribution remains in the best interest of PDL and its stockholders and that the distribution is still advisable.

Conference Call and Webcast

Dominique Monnet, PDL’s President and CEO, and Nick Curtis, LENSAR’s CEO, will hold a joint conference call to discuss this announcement and provide a business update on LENSAR at 4:30 p.m. Eastern time today, Thursday, September 10, 2020. Slides to accompany the conference call will be available in the Investor Relations section of View Source." target="_blank" title="View Source." rel="nofollow">View Source

To access the live conference call via phone, please dial 866-777-2509 from the United States or 412-317-5413 internationally. The conference ID is 10147821. A telephone replay will be available for one week beginning approximately one hour after the completion of the call and can be accessed by dialing 877-344-7529 from the U.S., 855-669-9658 from Canada or 412-317-0088 internationally. The replay passcode is 10147821.

To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of View Source and select "Events & Presentations."

Zai Lab Announces NMPA Approval of ZEJULA® (Niraparib) for First-Line Maintenance Treatment of Ovarian Cancer in China

On September 10, 2020 Zai Lab Limited (NASDAQ: ZLAB), an innovative commercial stage biopharmaceutical company, reported that the China National Medical Products Administration (NMPA) has approved its supplemental New Drug Application (sNDA) for ZEJULA (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy (Press release, Zai Laboratory, SEP 10, 2020, View Source [SID1234564931]).

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"We believe ZEJULA is a potential best-in-class PARP inhibitor. It is the first and only PARP inhibitor approved anywhere globally, including in China as monotherapy for all-comer patients in the first-line and recurrent maintenance treatment settings," said Dr. Samantha Du, Founder, Chairwoman and Chief Executive Officer of Zai Lab. "The NMPA’s rapid approval of our sNDA for ZEJULA underscores the unmet medical needs it serves and further enables Zai Lab to make a meaningful impact on the way ovarian cancer is treated in China."

"The approval of ZEJULA for the first-line maintenance treatment setting represents an opportunity to fundamentally change how women with ovarian cancer will be treated in China and a new standard of care for these patients," said Dr. Lingying Wu, Director of the Department of Gynecologic Oncology of the Cancer Hospital of China Academy of Medical Sciences. "In addition to its compelling efficacy data as monotherapy for all-comer patients, ZEJULA also has the convenience of once-daily dosing, excellent safety profile and attractive pharmacokinetic properties, including its ability to cross the blood brain barrier."

ZEJULA’s sNDA for the first-line maintenance treatment setting was accepted by the NMPA in March 2020, and was granted priority review status in April 2020.

About Ovarian Cancer

Ovarian cancer is one of the most common gynecologic cancers in China with approximately 52,000 newly diagnosed cases and 23,000 deaths in China per year. While platinum-based

chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women. Effective treatment options for patients with platinum-sensitive recurrent ovarian cancer remain limited. New agents that prolong the duration of response following platinum-based treatment and delay the inevitable relapse of ovarian cancer will benefit patients with ovarian cancer in China.

About ZEJULA (Niraparib)

ZEJULA (niraparib) is indicated as monotherapy for the maintenance treatment of adult patients with advanced and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first and second-line platinum-based chemotherapy.

The PRIMA study conducted by Zai Lab’s partner GlaxoSmithKline plc (GSK) demonstrated significant progression-free survival (PFS) improvement when given as monotherapy in women with first-line platinum responsive ovarian cancer, resulting in a 38% reduction in the risk of disease progression or death in the overall study population. Clinically meaningful reduction in risk of disease progression or death was further demonstrated with hazard ratios (HRs) of 0.40, 0.43 and 0.68 for BRCA mutant, HRD positive and HRD negative tumors, respectively. This study showed ZEJULA as the first PARP inhibitor to significantly improve PFS in this setting, regardless of biomarker status.

Zai Lab has several studies ongoing or completed in Chinese patients with ovarian cancer:

In November 2019, Zai Lab completed patient enrollment of its self-sponsored Phase III PRIME study evaluating ZEJULA as a first-line maintenance therapy in ovarian cancer patients who are in a complete or partial response to first-line platinum-based chemotherapy.

In May 2020, Zai Lab announced positive top-line results from its self-sponsored Phase III NORA study of ZEJULA as maintenance therapy for Chinese patients with platinum-sensitive, recurrent ovarian cancer. The full results from the NORA study will be presented at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2020 Virtual Congress on September 19, 2020.

In August 2020, the first patient was dosed in the registrational bridging trial for late-line ovarian cancer treatment.

Zai Lab also conducted a Phase I pharmacokinetic (PK) study of ZEJULA in Chinese patients with ovarian cancer.

ZEJULA is also being evaluated in China in a Phase Ib dose escalation and expansion clinical study, in combination with tebotelimab (PD-1 x LAG-3 DART molecule) for the treatment of patients with advanced or metastatic gastric cancer who failed prior treatment.

Zai Lab has a collaboration, development and license agreement with GSK for the development and commercialization of ZEJULA in Mainland China, Hong Kong and Macau.

Important Safety Information

The most common side effects for patients taking ZEJULA include heart not beating regularly, nausea, constipation, vomiting, pain in the stomach area, mouth sores, diarrhea, indigestion or heartburn, dry mouth, tiredness, loss of appetite, urinary tract infection, shortness of breath,

cough, rash, changes in liver function or other blood tests, pain in your joints, muscles, and back, headache, dizziness, change in the way food tastes, trouble sleeping, anxiety, sore throat and changes in the amount or color of your urine. Other potential serious side effects include bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of blood cancer called Acute Myeloid Leukemia (AML), symptoms of low blood cell counts (which can be a sign of serious bone marrow problems) and high blood pressures. Patients should take a few medical tests before they are treated with ZEJULA. Healthcare providers should periodically monitor their patients’ blood cell counts and blood pressures.

Bio-Path Holdings to Present at the H.C. Wainwright 22nd Annual Global Investment Conference

On September 10, 2020 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that Peter H. Nielsen, Chief Executive Officer, will present a corporate overview at the upcoming virtual H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday, September 16, 2020 at 11:30 a.m. ET (Press release, Bio-Path Holdings, SEP 10, 2020, View Source [SID1234564950]).

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A live webcast of the presentation can be accessed under "Events" in the Media section of the Company’s website at www.biopathholdings.com.

MiNA Therapeutics Secures £23 Million Series A Financing to Advance First-in-Class Activating RNA-Based Therapeutics

On September 10, 2020 MiNA Therapeutics, the pioneer in RNA activation therapeutics, reported the completion of a £23 million ($30 million) Series A equity financing led by aMoon, Israel’s largest healthtech and life sciences venture fund, with participation from existing investors (Press release, MiNA Therapeutics, SEP 10, 2020, View Source [SID1234564967]). The proceeds from the financing will be used to advance MiNA’s pipeline of proprietary, first-in-class, small activating RNA ("saRNA") therapeutics, and to support the continued clinical development of MiNA’s lead candidate, MTL-CEBPA, as a combination treatment in cancer. As part of the Series A financing, Dr. Gur Roshwalb, M.D., M.B.A., Managing Director at aMoon, has joined the Board of Directors at MiNA Therapeutics. MTS Securities, LLC acted as the exclusive placement agent in connection with the financing.

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"Since the inception of MiNA Therapeutics, we have been focused on advancing the Company by validating our innovative therapeutic approach in patients and establishing strategic collaborations with leading academic institutions and industry partners," said Robert Habib, CEO of MiNA Therapeutics. "This financing represents an important step in our evolution that will not only fund our continued clinical development in patients with cancer but will also enable us to further explore the potential of our pioneering approach in therapeutic areas beyond oncology. We are grateful for the support from our existing investors and are honoured to welcome aMoon to MiNA."

"To date, MiNA’s innovative small activating RNA therapeutic approach has demonstrated the potential to modulate previously undruggable targets in difficult-to-treat indications such as liver cancer," said Dr. Gur Roshwalb, Managing Director at aMoon. "We strongly believe in the potential of this new class of medicines and look forward to collaborating with the team at MiNA to support the continued growth of this technology platform."

saRNA medicines have the potential to transform the therapeutic landscape of cancer and other severe metabolic and genetic diseases. MiNA’s lead candidate, MTL-CEBPA, is a first-in-class therapy that reduces immune suppression in the tumour microenvironment. MTL-CEBPA has been studied in clinical trials in more than 70 patients with advanced liver cancer, demonstrating unprecedented initial results. Used in combination with the standard primary cancer treatment drug, sorafenib, MTL-CEBPA improved the rate, duration and depth of response when compared to data independently reported from third-party studies with single agent sorafenib therapy. The additional funding will enable MiNA Therapeutics to conduct a Phase 2 study of MTL-CEBPA in combination with sorafenib in patients with advanced liver cancer and TIMEPOINT, an ongoing Phase I/Ib study of MTL-CEBPA in combination with pembrolizumab in patients with advanced solid tumour malignancies. Additionally, the proceeds will fund research activities to advance a pipeline of novel small activating RNA therapies for the treatment of cancer, metabolic and genetic diseases.

Universal Health Services, Inc. Announces Offering Of Senior Secured Notes

On September 10, 2020 Universal Health Services, Inc. (NYSE: UHS) reported an offering of senior secured notes due 2030 (the "Notes") (Press release, Universal Health Services, SEP 10, 2020, View Source [SID1234564983]). The Company intends to use the net proceeds of the offering, together with cash on hand, to redeem all of the outstanding $700 million aggregate principal amount of its 4.750% Senior Secured Notes due 2022 (the "Existing 2022 Notes") on September 28, 2020, to pay accrued and unpaid interest on the Existing 2022 Notes to but excluding the date of redemption, to pay transaction expenses and for general corporate purposes.

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The Notes have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law and, unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable state securities laws. The Notes will be offered only to persons reasonably believed to be qualified institutional buyers under Rule 144A of the Securities Act and outside the United States under Regulation S of the Securities Act.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the Notes in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any offers of the Notes will be made only by means of a private offering memorandum. This notice is being issued pursuant to and in accordance with Rule 135(c) under the Securities Act.

Certain statements in this release may constitute forward-looking statements and are subject to various risks and uncertainties as discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not obligated to update these forward-looking statements even if the Company’s assessment of these risks and uncertainties changes.

Universal Health Services, Inc. ("UHS") is one of the nation’s largest providers of hospital and healthcare services. Through its subsidiaries, UHS operates acute care hospitals, behavioral health facilities, outpatient facilities and ambulatory care access points located throughout the United States, Puerto Rico and the United Kingdom.