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."

On September 10, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that members of management will present virtually at the H.C. Wainwright & Co. 22nd Annual Global Investment Conference on September 14th and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22nd (Press release, Moleculin, SEP 10, 2020, View Source [SID1234564930]).

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

H.C. Wainwright 22nd Annual Global Investment Conference:
Date: Monday, September 14th, 2020
Time: 5:00 PM ET
Link: View Source

Oppenheimer Fall Healthcare Life Sciences & MedTech Summit:
Date: Tuesday, September 22nd, 2020
Time: 10:00 AM ET
Link: View Source

Replays of the presentations will be available on the Company’s website for 90 days following the event. Members of management will hold 1-on-1 virtual investor meetings at the conferences. Investors attending the conferences virtually who are interested in meeting with Company management should contact their H.C Wainwright and Oppenheimer representatives.

On September 10, 2020 Casma Therapeutics, Inc., a biotechnology company harnessing autophagy and the lysosome to design powerful new medicines, reported the completion of a $50 million Series B financing (Press release, Casma Therapeutics, SEP 10, 2020, View Source [SID1234564966]).

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The financing, led by The Column Group (TCG), adds new investors Eventide Asset Management, LLC and Schroder Adveq, as well as other undisclosed institutional investors. Existing investor Third Rock Ventures also participated in the Series B. In connection with the financing, Millie Ray, Ph.D., from The Column Group, will join Casma’s Board of Directors. Finny Kuruvilla, M.D., Ph.D., chief investment officer of Eventide Asset Management, LLC will become a board observer.

The proceeds from the financing will allow Casma to advance their TRPML1 agonist program into development for muscular dystrophy, as well as continue to develop the Company’s Autophagy Degrader Platform (ADP). TRPML1 regulates the repair of the plasma membrane of muscle cells following damage, addressing the core pathology in multiple forms of muscular dystrophy. ADP is a novel approach for the degradation of multiple disease-causing targets. The autophagy system is able to degrade disease targets substantially larger and more diverse than those that rely on E3 ligase-based or proteasomal degradation approaches.

"We are very excited to welcome TCG, Eventide Asset Management, LLC and Schroder Adveq as investors in Casma. We believe our investors’ strong focus on science, combined with their established position in the life sciences ecosystem, will aid us in continuing to forge ahead as pioneers in this novel area of biology," said Keith Dionne, Ph.D., chief executive officer of Casma Therapeutics. "We look forward to the insight and leadership Drs. Ray and Kuruvilla will bring to Casma’s board."

"TCG has been interested in the power of harnessing the autophagy-lysosomal pathway for some time and we are excited to help Casma advance multiple therapies toward the clinic and ultimately, the marketplace. I am looking forward to working with the Casma team on leveraging this powerful technology to create novel therapies for multiple unmet medical needs," said Dr. Ray.

On September 10, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported its financial outlook for full year 2020 (Press release, Quest Diagnostics, SEP 10, 2020, View Source [SID1234564982]).

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Since the company reported its financial performance for the second quarter of 2020 on July 23, 2020, organic testing volumes in its base business (excluding COVID-19 molecular and antibody testing and the impact of acquisitions), continued to recover faster than anticipated through the end of August. Organic base testing volumes declined high single digits in July and mid-to-high single digits in August on a percentage basis versus the prior year. COVID-19 molecular and antibody testing volumes remain consistent with the company’s previous outlook.

Updated Outlook for Full Year 2020

Net revenues increase
The company is scheduled to participate in the Wells Fargo Virtual Healthcare Conference today at 1:20 p.m. Eastern Time. The presentation will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. During the discussion, the company’s management plans to discuss its current perspective on the impact of the COVID-19 pandemic.

Management continues to believe that the COVID-19 pandemic’s impact on its future operating results, cash flows and/or financial condition will be primarily driven by a number of factors beyond the company’s knowledge and control, including: the pandemic’s severity and duration; the pandemic’s impact on the U.S. healthcare system and the U.S. economy; and the timing, scope and effectiveness of federal, state and local governmental responses to the pandemic.

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, certain financial impacts resulting from the COVID-19 pandemic, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, a gain on the remeasurement of an equity interest, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts; and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional table attached below includes a reconciliation of non-GAAP adjusted measures to GAAP measures.

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.