Entry into a Material Definitive Agreement

On May 8, 2020, Advaxis, Inc. (the "Company") reported that it entered into a Sales Agreement (the "Sales Agreement") with A.G.P./Alliance Global Partners, as sales agent ("A.G.P."), pursuant to which the Company may offer and sell (the "Offering"), from time to time, at its option, through or to A.G.P., up to an aggregate of $40,000,000 of shares of the Company’s common stock, $0.001 par value per share (the "Shares") (Filing, 8-K, Advaxis, MAY 8, 2020, View Source [SID1234557380]). Any Shares to be offered and sold under the Sales Agreement will be issued and sold pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-226988), filed with the Securities and Exchange Commission (the "SEC") on August, 23, 2018, and declared effective on August 30, 2018 (the "Registration Statement") and the prospectus supplement relating to the Offering, dated May 8, 2020, that will be filed with the SEC, by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or if specified by the Company, by any other method permitted by law, including, but not limited to, in negotiated and block transactions.

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Subject to the terms of the Sales Agreement, A.G.P. will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company cannot provide any assurances that it will issue any Shares pursuant to the Sales Agreement. The Company will pay A.G.P. a commission at a fixed rate of 3.0% of the gross proceeds from each sale of the Shares under the Sales Agreement. The Company will also reimburse A.G.P. for certain expenses incurred in connection with the Sales Agreement and agreed to provide A.G.P. with customary indemnification rights with respect to certain liabilities, including liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended.

The Sales Agreement will terminate upon the earliest of (a) the sale of the maximum number or amount of the Shares permitted to be sold under the Sales Agreement, (b) the termination of the Sales Agreement by either of the parties thereto, and (c) the expiration of the Registration Statement on the third anniversary of the Registration Statement’s initial effective date.

The Company currently intends to use any net proceeds from the Offering to fund its continued research and development initiatives in connection with expanding its product pipeline including, but not limited to, investment in its ADXS-HOT program and for general corporate purposes.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement, which is attached hereto as Exhibit 1.1 and incorporated by reference herein.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there be any offer, solicitation or sale of the Shares in any state or country in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or country.

Celsion Corporation to Hold First Quarter 2020 Financial Results Conference Call on Friday, May 15, 2020

On May 8, 2020 Celsion Corporation (NASDAQ: CLSN) reported that the Company will host a conference call to discuss financial results for the first quarter ended March 31, 2020 and provide an update on its development programs for ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin and GEN-1, an IL-12 DNA plasmid vector formulated into a nanoparticle with a non-viral delivery system at 11:00 a.m. EDT on Friday, May 15, 2020 (Press release, Celsion, MAY 8, 2020, View Source [SID1234557414]).

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To participate in the call, interested parties may dial 1-800-367-2403 (Toll-Free/North America) or 1-334-777-6978 (International/Toll) and ask for the Celsion Corporation First Quarter 2020 Earnings Call (Conference Code: 6901311) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com. The call will be archived for replay on Monday, May 18, 2020 and will remain available until June 1, 2020. The replay can be accessed at 1-719-457-0820 or 1-888-203-1112 using Conference ID: 6901311. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. EDT Friday, May 15, 2020.

Personalis Reports First Quarter 2020 Financial Results

On May 7, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported financial results for the first quarter ended March 31, 2020 (Press release, Personalis, MAY 7, 2020, View Source [SID1234557264]).

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First Quarter Highlights

Reported record revenues of $19.2 million in the first quarter of 2020 versus $14.1 million in the first quarter of 2019, an increase of 36%

A total of 26 customers have placed orders for NeXT as of March 31, 2020, with 7 of those customers placing their orders in the first quarter of 2020

Received a new order outside of oncology to deliver neoantigen prediction, which will leverage the Company’s proprietary technology platform

"I’m proud to say that we were able to report record revenues once again this quarter, in spite of the initial impact from the COVID-19 pandemic, and continued to see strong ordering levels from both our existing and new customers," said John West, Chief Executive Officer. "Also, while our laboratory operations have been scaled down due to the COVID-19 shelter-in-place orders, and will be at least through May, we feel well-positioned to work through our VA MVP samples and also service our biopharma customers when they are able to send us their samples."

First Quarter 2020 Financial Results

Revenues were $19.2 million in the three months ended March 31, 2020, up 36% from $14.1 million in the same period of the prior year. First quarter revenue growth was driven by an increase in volume for testing and analytical services provided to the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP). In the first quarter, the VA MVP accounted for $14.8 million, or 77%, of revenues and the remaining $4.4 million, or 23%, was from biopharmaceutical and all other customers.

Gross margin was 21.1% for the three months ended March 31, 2020, compared with 28.3% in the same period of the prior year.

Operating expenses were $13.7 million for the three months ended March 31, 2020, compared with $9.4 million in the same period of the prior year.

Net loss was $9.1 million for the three months ended March 31, 2020 and net loss per share was $0.29 based on a weighted-average basic and diluted share count of 31.3 million, compared with a net loss of $5.7 million and a net loss per share of $1.84 on a weighted-average basic and diluted share count of 3.1 million in the same period of the prior year.

Cash, cash equivalents, and short-term investments were $120.0 million as of March 31, 2020.

Outlook and COVID-19

Due to uncertainty surrounding the COVID-19 pandemic, Personalis will not provide an outlook for fiscal 2020 at this time, and will plan to give an update during its second quarter earnings announcement and press release, to the extent practicable, based on available information at that time.

Webcast and Conference Call Information

Personalis will host a conference call to discuss the first quarter financial results after market close on Thursday, May 7, 2020 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using conference ID: 9370329. The live webinar can be accessed at View Source

PDL BioPharma Reports 2020 First Quarter Financial Results

On May 7, 2020 PDL BioPharma, Inc. ("PDL" or "the Company") (Nasdaq: PDLI) reported financial results for the three months ended March 31, 2020 and provides a business update (Press release, PDL BioPharma, MAY 7, 2020, View Source [SID1234557280]):

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In March 2020, the Company announced that its Board of Directors (the "Board") approved a Plan of Complete Liquidation and passed a resolution to seek stockholder approval at its next Annual Meeting of Stockholders to dissolve the Company under Delaware state law in the event the Board concludes that the whole Company sale process is unlikely to maximize the value that can be returned to the stockholders. The Company has not set a definitive timeline to file for dissolution and intends to pursue its monetization strategy in a disciplined and cost-effective manner seeking to maximize returns to stockholders. The Company recognizes, however, that accelerating the timeline, while continuing to seek to optimize asset value, could increase returns to stockholders due to reduced general and administrative ("G&A") expenses as well as potentially providing faster returns to stockholders. While the Company cannot provide a definitive timeline for the liquidation process, it has been targeting the end of 2020 for completing the monetization of its key assets. However, the Company recognizes that the duration and extent of the public health issues related to the COVID-19 pandemic make it possible, and perhaps probable, that the timing may be delayed. As announced previously, the Company has engaged financial advisors and initiated processes either to sell these assets separately or to transact the Company as a whole.

"We continue to execute on the strategy of monetizing our assets to unlock the full value of the company for our stockholders," said Dominique Monnet, president and CEO of PDL. "Our plan is to follow a disciplined approach with a focus on maximizing net proceeds. We remain confident in the high quality of our assets, and we believe that they are attractive acquisition targets.

"Earlier this week we announced Board of Director approval for a distribution of all of PDL’s shares of Evofem Biosciences common stock via a special one-time dividend to PDL stockholders as our first distribution under the Plan of Complete Liquidation," he added "We previously stated the ambitious goal of completing the monetization of our key assets by the end of 2020. While we are encouraged by our progress, we recognize that the impact of the COVID-19 pandemic on our assets and the businesses of potential buyers of those assets could cause some delays, which makes it possible, and perhaps probable, that the timing of the sale or sales may be delayed. Again, our intent is to pursue monetization in a disciplined and cost-effective manner and to distribute the net proceeds to stockholders in a tax-efficient manner in the form of share repurchases and dividends, or by other means."

Discontinued Operations Classified as Assets Held for Sale

As a result of these decisions and the actions put in place in the first quarter of 2020, at March 31, 2020 the assets held for sale and discontinued operations criteria were met for the Company’s royalty assets and for Noden Pharma, its pharmaceutical segment. The royalty assets are a component of the Income Generating Assets segment.

During the period in which a component meets the assets held for sale and discontinued operations criteria, an entity must present the assets and liabilities of the discontinued operation separately in the asset and liability sections of the balance sheet for the current and comparative reporting periods. The prior period balance sheet is reclassified for the held for sale items. For statements of operations, the current and prior periods report the results of operations of the component in discontinued operations. While the current period and prior period are presented herein on a comparative basis in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), the presentation has changed from the reporting of GAAP financial results in our fourth quarter 2019 earnings release.

First Quarter Financial Highlights

Total revenues were $6.0 million, consisting primarily of LENSAR product revenue.

LENSAR revenues were $6.0 million, a decrease of 11% over the prior-year period, with procedure volume declining 6%.

Net cash from all royalty rights was $13.6 million, up 8% from $12.6 million for the prior-year period.

U.S. market share for branded Tekturna and the authorized generic of Tekturna of approximately 68% at March 31, 2020 declined from 73% as of December 31, 2019.

GAAP net loss was $31.7 million. Non-GAAP net loss was $6.7 million. A reconciliation of GAAP to non-GAAP financial results can be found in Table 4 at the end of this news release.

Revenue Highlights

Total revenues for the first quarter of 2020 were $6.0 million and consisted primarily of LENSAR product revenue.

Product revenue from LENSAR was $6.0 million, an 11% decrease from the first quarter of 2019. LENSAR procedure volume for the first quarter of 2020 declined 6% from the prior-year period, primarily due to lower system sales and procedures driven by the negative impact of the COVID-19 pandemic and the associated deferral of elective medical procedures, primarily in South Korea and China. While LENSAR U.S. operating results for the first quarter of 2020 were not impacted as significantly by the COVID-19 pandemic, beginning in late March and into the second quarter of 2020 the pandemic resulted in the cancellation of practically all elective cataract surgeries. LENSAR operating results are expected to improve as elective medical procedures gradually open throughout the remainder of 2020.

Operating Expense Highlights

Operating expenses from continuing operations of the Company include G&A expenses for corporate overhead as these costs have historically not been allocated to individual segments.

Operating expenses for the first quarter of 2020 were $37.9 million, a $23.0 million increase from the first quarter of 2019. The increase was primarily a result of an acceleration of equity awards and the accrual for cash severance and retention payments under our wind-down retention plan totaling $18.7 million, and for increased professional service costs. The vesting of equity awards was accelerated when the Board approved a Plan of Complete Liquidation in February 2020 as this action constituted a change in control.

There were decreases in cost of product revenue and sales and marketing expenses in our Medical Devices segment due to a decline in revenue, while G&A and research and development expenses reflected modest increases.

Net loss from continuing operations for the first quarter of 2020 was $31.8 million, a $23.3 million increase from the first quarter of 2019.

Discontinued Operations Highlights

Discontinued operations consist of the following items:

Net royalty revenues from acquired royalty rights, which include cash royalties received and a change in fair value of the royalty rights assets, were $9.4 million compared with $12.3 million in the prior-year period. The decrease is primarily related to the anticipated decrease in fair value of the royalty rights for the Type 2 diabetes products acquired from Assertio Therapeutics. PDL received $13.6 million in net cash from all its royalty rights in the first quarter of 2020, up from $12.6 million in the prior-year period. See Table 3 for a rollforward of royalty assets for the first quarter of 2020 compared with the comparable period in 2019.

The asset held for sale classification requires the Company to record the estimated cost to sell the asset as a deduction to the carrying value of the asset. In the first quarter of 2020, the Company recorded $6.0 million as the estimated cost to sell the royalty assets.

Product revenue from Noden was $15.0 million compared with $20.0 million in the prior-year period. Revenues for the U.S. and the rest of the world were $3.9 million and $11.1 million, respectively, compared with $12.2 million and $7.8 million, respectively, in the prior-year period. The decline in U.S. revenue is primarily a result of the launch of an authorized generic of Tekturna as well as the launch of a third-party generic form of aliskiren in March 2019. U.S. market share for branded Tekturna and authorized generic of Tekturna of approximately 68% declined from the market share of 73% as of December 31, 2019.

In the first quarter of 2020, the Company recorded $1.9 million as the estimated cost to sell Noden.

Net loss from discontinued operations for the first quarter of 2020 was $0.2 million, a $15.3 million decrease from the first quarter of 2019. The decrease was primarily due to the estimated cost to sell the assets classified as held for sale of $7.9 million and the write down of Noden to reflect fair value upon its reclassification as an asset held for sale.

Other Financial Highlights

As of March 31, 2020, the Company’s investment in Evofem had a market value of $82.6 million, a decrease of $13.8 million from December 31, 2019. The Company acquired its investment in Evofem in two tranches in the second quarter of 2019, for a total of $60.0 million.

On a GAAP basis, the net loss attributable to PDL’s stockholders for the first quarter of 2020 was $31.7 million, or $0.26 per share, compared with GAAP net income attributable to PDL’s stockholders of $6.7 million, or $0.05 per diluted share, for the prior-year period. Non-GAAP net loss attributable to PDL’s stockholders was $6.7 million for the first quarter of 2020, compared with non-GAAP net income of $11.9 million for the first quarter of 2019.

PDL had cash and cash equivalents from continuing operations of $125.5 million as of March 31, 2020, compared with $169.0 million as of December 31, 2019.

The $43.5 million reduction was primarily the result of common stock repurchases of $19.2 million, the net cash used for the repurchase of convertible debt of $18.0 million and net cash used in operations of $14.6 million. This reduction was partially offset by the proceeds from royalty rights of $13.6 million.

Stock Repurchase Programs

In January 2020, PDL began repurchasing shares of its common stock in the open market pursuant to the
10b5-1 program entered into in December 2019. In the first quarter of 2020, the Company acquired 6.3 million shares for $20.3 million, at an average cost of $3.20 per share, including commissions.

Under this same program, in the first quarter of 2020, the Company also repurchased $15.9 million par value of convertible notes.

As of April 30, 2020, the Company had approximately 116.5 million shares of common stock outstanding.

Conference Call and Webcast

PDL will hold a conference call to discuss financial results and provide a business update at 4:30 p.m. Eastern time today. Slides to accompany the conference call will be available in the Investor Relations section of View Source

To access the live conference call via phone, please dial 844-535-4071 from the U.S. and Canada or 706-679-2458 internationally. The conference ID is 7238226. 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 855-859-2056 from the U.S. and Canada or 404-537-3406 internationally. The replay passcode is 7238226.

Sesen Bio Reports Positive Interactions with EMA on Regulatory Pathway for Vicinium®

On May 7, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that the Company has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the regulatory pathway for Vicinium in Europe (Press release, Sesen Bio, MAY 7, 2020, View Source [SID1234557296]). The Company’s lead program, Vicinium, also known as VB4-845, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In December 2019, the Company initiated the BLA submission for Vicinium to the United States Food and Drug Administration (FDA) under Rolling Review.

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"We are very pleased to have received positive guidance from the CHMP on the regulatory approval pathway for Vicinium," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We strongly believe that Vicinium is a highly differentiated product candidate that is well positioned to address the considerable unmet need in NMIBC. This encouraging progress reinforces our confidence in bringing Vicinium to market in Europe, which represents a tremendous opportunity for the company. We will continue working collaboratively with the EMA to move Vicinium through the approval process as expeditiously as possible."

Key Elements of CHMP Scientific Advice

The CHMP agreed that the Company’s nonclinical, clinical pharmacology and safety database are all sufficient to support a marketing authorization application (MAA). Furthermore, additional clinical trials were not requested by the CHMP in support of the MAA submission for Vicinium.
The CHMP agreed that due to the well-known impact of cystectomy on morbidity and quality of life of patients, a new local treatment that enables patients to avoid radical cystectomy would be meaningful, especially for patients who are contraindicated for cystectomy.
The CHMP provided guidance on additional data analyses they expect to be included in the MAA, and the Company is confident that these can be fully addressed with the completed Phase 3 dataset.
Based on the guidance received, the Company expects to submit the MAA for Vicinium to the EMA in early 2021, with potential approval anticipated in early 2022.
The Company expects to receive Scientific Advice from the CHMP on the Chemistry, Manufacturing and Controls (CMC) program for Vicinium at a later date.
The Company believes there is a significant commercial opportunity in Europe and projects European peak sales to be substantially greater than US peak sales, driven by the significantly higher incidence rates and strong pricing benchmarks in the region.

About Vicinium

Vicinium, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicinium promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.