On April 3, 2020 Cellect Biotechnology Ltd. (Nasdaq: APOP), a developer of a novel stem cell production technology, reported operating and financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Cellect Biotechnology, APR 3, 2020, View Source [SID1234556132]).

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"We achieved a number of strategic priorities in 2019, including the IND approval to commence our first-ever trial in the U.S.," commented Dr. Shai Yarkoni, Chief Executive Officer. "We plan to begin enrolling patients for this trial and completing the trial in Israel when the COVID-19 pandemic is mitigated. While these near-term events are value-enhancers, I believe that our recently announced prospective partnership with Canndoc could be a game-changer for Cellect and change our growth trajectory. It has the potential to significantly enhance our short and long term business prospects and shareholder value. As a player in the fast-growing pain management market, we would anticipate significant revenue opportunities already this year."

Recent Strategic Development

As previously announced, on March 4, 2020, the Company entered into a commercial binding Letter Of Intent (LOI) with Canndoc Ltd, a leading pharma grade medical cannabis pioneer and a wholly owned subsidiary of publicly-traded Intercure Ltd. (TASE: INCR), to acquire from Canndoc all rights to the use and sell Canndoc products for the reduction of opioid usage, including accumulated data, as well as on-going and pipeline of clinical trials. This commercial arrangement is subject to negotiation and approval by each company’s board of directors and definitive agreements.

Additionally, the two companies signed a non-binding LOI for a full merger. Under preliminary details, Cellect will acquire from Intercure all of Canndoc outstanding shares, in exchange for additional Cellect ADRs to be in total ~95% (~93% on a fully diluted basis) of the merged company. The proposed merger is subject to independent valuation of both companies, fairness opinion by a third party, negotiation of a definitive agreement, approval of the agreement by the Company’s Board of Directors and shareholders, internal approvals by Canndoc and Intercure, and customary closing conditions, including the approval of the IMCA (Israeli Medical Cannabis Agency). Upon the closing of the merger, Cellect and Canndoc will aim to fulfill all of the requirements to ensure the Company’s ADRs and warrants continue trading on the Nasdaq Stock Market (Nasdaq) and, for this purpose, Intercure would commit to invest a cash sum of at least $3.0 million in any public offering that is undertaken by the Company, at a price of not less than $4.50 per ADR.

Based on the progress to date, the Company continues to expect the commercial and merger transactions will close in the second quarter of 2020.

Additional Operating Highlights:

The Phase 1/2 clinical trial in Israel has successfully recruited 11 of the 12 patients needed to complete the trial, and subject to COVID-19 and resumption of normal activities, , the Company anticipates recruiting the final patient and publishing top line results by the end of 2020.
Received all the necessary technology and regulatory approvals, including an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to evaluate the safety and tolerability of the ApoGraft technology for haploidentical bone marrow transplantations.
Prior to the delaying of the Cell & Gene Meeting on the Mediterranean and the International Congress on Autoimmunity due to the ongoing COVID-19 pandemic, the Company was selected to present data via oral presentations, further bolstering the Company’s peer-reviewed credentials and growing body of clinical evidence
Featured article highlighting the safety and tolerability of ApoGraft, Company’s novel stem cell selection technology was approved for publication in Bone Marrow Transplantation, a high quality, peer-reviewed journal published monthly by Nature Research and covering all aspects of clinical and bone marrow transplantation
Expanded intellectual property (IP) portfolio in multiple jurisdictions. The Company now has 65 patent applications worldwide, of which 33 are issued/allowed patents, and plans to continue expanding and protecting its global IP to create further barriers to entry
Strengthened the balance sheet through a registered direct offering of $7.0 million (February 2019) and a registered direct offering of $3.0 million (January 2020), totaling $10 million, before deducting fees and other offering expenses.
Clinical Progress Update:

Due to the ongoing COVID-19 pandemic, the Company is experiencing clinical disruption such as:

In Israel, the recruitment of patients in the final cohort for the Phase 1/2 clinical trial has been halted. Previously, the Company had anticipated completion of this trial in the second quarter of 2020.
– Published mid-study data from the first half of patients was positive. All patients transplanted using the ApoGraft process were engrafted and time to engraftment was not changed.
-To date, there have not been any safety concerns during the study and patient enrollment is continuing.
In the U.S., the Phase 1/2 clinical trial, which was scheduled to begin enrolling patients in the first half of 2020, is delayed as major academic centers have suspended trials not affiliated with COVID-19.
– The Company is collaborating with Washington University (WU) School of Medicine in St. Louis on the trial.
– A total of 18 patients are planned for the initial phase.
– Completed the technology transfer to WU’s facility enabling the study to initiate immediately after the COVID-19 pandemic is mitigated.
The Company continues to take all the necessary precautions advised by global health officials to ensure the health and safety of its employees and partners. The Company is unaware of any impact on employees from pandemic related exposure or illness and is continuing to perform in-house research, including in the opioid/pain management area.

Fourth Quarter and Full Year 2019 Financial Results:

Research and development (R&D) expenses for the fourth quarter and for the full year of 2019 were $0.74 million and $3.51 million respectively, compared to $1.17 million in the fourth quarter of 2018 and $3.91 million for the full year of 2018. The decrease in R&D expenses for the full year of 2019 as compared to the full year of 2018 resulted from the reduction in our research and development activities, as we decreased the number of our employees engaged in research and related activities.
General and administrative (G&A) expenses for the fourth quarter and for the full year of 2019 were $0.69 million and $2.95 million respectively, compared to $1.37 million in the fourth quarter of 2018 and $4.55 million for the full year of 2018. The decrease in G&A expenses for the full year of 2019 as compared to the full year of 2018 resulted from the reduction in management salaries and travel expenses
Finance expenses for the fourth quarter of 2019 were $0.33 million, and financial income was $1.60 million for the full year of 2019, compared to finance expenses of $1.45 million in the fourth quarter of 2018 and financial income of $2.64 million for the full year of 2018, respectively. The financial income in the full year of 2019 as compared to the financial income in the full year of 2018 is primarily due to the change in the fair value of the listed warrants granted in our U.S. initial public offering in 2016 and of the unregistered warrants granted in our registered direct offerings in 2019.
Total Comprehensive loss for the fourth quarter and for the full year of 2019 was $1.76 million and $4.86 million respectively, or $0.008 per share for the fourth quarter and $0.023 per share for the full year of 2019, respectively, compared to $1.09 million, or $0.008 per share, in the fourth quarter of 2018 and $5.82 million, or $0.045 per share, for the full year of 2018.
Balance Sheet Highlights:

Cash and cash equivalents totaled $5.24 million as of December 31, 2019, compared to $6.32 million on September 30, 2019, and $5.15 million on December 31, 2018. The change compared to December 31, 2018 was primarily due to the net proceeds of $5.8 million in a registered direct offering in February 2019, offset by ongoing operational expenses.
Subsequent to the end of the full year, on January 8, 2020, the Company raised $3.0 million through a registered direct offering, before deducting fees and other estimated offering expenses.
Shareholders’ equity totaled $4.29 million as of December 31, 2019, compared to $5.34 million on September 30, 2019, and $4.03 million on December 31, 2018.
For the convenience of the reader, the amounts have been translated from NIS into U.S. dollars, at the representative rate of exchange on December 31, 2019 (U.S. $1 = NIS 3.456).

On April 3, 2020 Haemonetics Corporation (NYSE: HAE) reported that the Company intends to publish fourth quarter and fiscal year 2020 financial results at 6:00 am EDT on Tuesday, May 5, 2020 (Press release, Haemonetics, APR 3, 2020, View Source [SID1234556131]). The Company will hold a conference call with investors and analysts to discuss results and answer questions at 8:00 am EDT on May 5, 2020.

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The call can be accessed with the following information:

U.S. / Canada toll free (877) 848-8880; International (716) 335-9512
Conference ID required for access: 7365511

A live webcast of the call can be accessed on Haemonetics’ investor relations website. Webcast Link: View Source

Webcast replay will be available from May 5, 2020 after 11:00 am EDT.

On April 3, 2020 Nevro Corp. ("Nevro") (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported that the underwriter of each of Nevro’s previously announced concurrent public offerings of (a) 1,625,000 shares of its common stock (the "common stock offering") and (b) $165,000,000 aggregate amount of its 2.75% convertible senior notes due 2025 (the "initial notes") (the "notes offering") has fully exercised its option to purchase an additional (a) 243,750 shares of Nevro’s common stock at a public offering price of $84.00 per share, less underwriting discounts and commissions, and (b) an additional $24,750,000 aggregate amount of notes (the "additional notes" and, collectively with the initial notes, the "notes"), less underwriting discounts and commissions (Press release, Nevro, APR 3, 2020, View Source [SID1234556130]). Following the full exercise of the underwriter’s option, Nevro anticipates selling an aggregate of 1,868,750 shares of its common stock, with total gross proceeds of approximately $157.0 million before deducting underwriting discounts and commissions and estimated offering expenses, and $189,750,000 aggregate amount of notes, before deducting underwriting discounts and commissions and estimated offering expenses. The offerings, including the common stock and additional notes that are part of the option exercise, are expected to close on April 6, 2020, subject to customary closing conditions.

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The notes will be senior, unsecured obligations of Nevro, and will bear interest at a rate of 2.75% per year. Interest will be payable semi-annually in arrears on April 1 and October 1 of each year, beginning on October 1, 2020. The notes will mature on April 1, 2025, unless earlier repurchased or converted. Nevro may not redeem the notes, and no sinking fund is provided for the notes. Holders of the notes will have the right to require Nevro to repurchase all or a portion of their notes upon the occurrence of a fundamental change (as defined in the indenture governing the notes) at a cash purchase price of 100% of their principal amount plus any accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

The notes may be converted at an initial conversion rate of 9.5238 shares of Nevro’s common stock per $1,000 principal amount of notes (which is equivalent to an initial conversion price of approximately $105.00 per share and represents a conversion premium of 25.0% to the public offering price of Nevro’s common stock in the common stock offering). Prior to the close of business on the business day immediately preceding October 1, 2024, the notes will be convertible at the option of the holders of the notes only upon the satisfaction of specified conditions and during certain periods. On or after October 1, 2024 until the close of business on the second scheduled trading day preceding the maturity date, the notes will be convertible at the option of the holders of notes at any time regardless of these conditions. Conversions of the notes will be settled in cash, shares of Nevro’s common stock or a combination thereof, at Nevro’s election.

In connection with the exercise of the underwriter’s option to purchase additional notes, Nevro entered into privately-negotiated convertible note hedge transactions with the underwriter and/or its affiliate and/or other financial institutions (the "option counterparties"). These transactions cover, subject to customary anti-dilution adjustments, the number of shares of Nevro’s common stock that will initially underlie the additional notes, and are expected generally to reduce the potential equity dilution, and/or offset any cash payments in excess of the principal amount due, as the case may be, upon conversion of the additional notes. Nevro entered into separate, privately-negotiated warrant transactions with the option counterparties at a higher strike price relating to the same number of shares of Nevro’s common stock, subject to customary anti-dilution adjustments, pursuant to which Nevro will sell warrants to the option counterparties. The warrants could have a dilutive effect on Nevro’s outstanding common stock to the extent that the price of Nevro’s common stock exceeds the strike price of those warrants. The strike price of the warrants will initially be $147.00 per share, which represents a premium of approximately 75% over the public offering price of Nevro’s common stock in the common stock offering, and is subject to certain adjustments under the terms of the warrant transactions.

Morgan Stanley is acting as bookrunning manager for the offerings.

Nevro has been advised that in connection with establishing their initial hedges of the convertible note hedge and warrant transactions, the option counterparties or their respective affiliates expect to enter into various derivative transactions with respect to Nevro’s common stock. This activity could increase (or reduce the size of any decrease in) the market price of Nevro’s common stock or the notes at that time. The option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Nevro’s common stock and/or purchasing or selling Nevro’s common stock or other securities of Nevro in secondary market transactions from time to time prior to maturity of the notes (and are likely to do so during any observation period related to a conversion of the notes).

The potential effect, if any, of these transactions and activities on the market price of Nevro’s common stock or the notes will depend in part on market conditions and cannot be ascertained at this time, but any of these activities could adversely affect the value of Nevro’s common stock, which could affect the ability to convert the notes, the value of the notes and the amount of cash, if any, and the number of and value of the shares of Nevro’s common stock, if any, holders would receive upon conversion of the notes.

Nevro intends to use a portion of the net proceeds from the sale of additional notes, together with the proceeds from the sale of additional warrants, to enter into additional convertible note hedge transactions with the option counterparties. Nevro expects to use the remainder of the net proceeds from the sale of additional shares of its common stock and the additional notes for general corporate purposes, including the repayment of its 1.75% Convertible Senior Notes due 2021 (the "existing convertible notes") at maturity and Nevro may use a portion of the remaining net proceeds to repurchase a portion of the existing convertible notes prior to their maturity.

A shelf registration statement on Form S-3 (including a base prospectus) relating to the common stock offering and the notes offering was automatically declared effective by the Securities and Exchange Commission ("SEC"). Preliminary prospectus supplements related to each of the common stock offering and the notes offering (together with such base prospectus, each a "prospectus"), have been filed with the SEC and are available on the SEC’s website located at www.sec.gov. Copies of the prospectus relating to the common stock offering and the notes offering may be obtained, when available, from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014.

On April 3, 2020 Medpace Holdings, Inc. (Nasdaq:MEDP) ("Medpace") reported that it will report its first quarter 2020 financial results after the market close on Tuesday, April 28, 2020 (Press release, Medpace, APR 3, 2020, View Source [SID1234556129]). The Company will host a conference call the following morning, Wednesday, April 29, 2020, at 9:00 a.m. ET to discuss these results.

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To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 5203559.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at investor.medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

A recording of the call will be available from 12:00 p.m. ET on Wednesday, April 29, 2020 until 12:00 p.m. ET on Wednesday, May 13, 2020. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 5203559.

On April 3, 2020 Horizon Discovery Group plc (LSE: HZD) ("Horizon", "the Company" or "the Group"), a global leader in the application of gene editing and gene modulation for cell line engineering, reported the addition of an arrayed CRISPR knockout screening service for primary human B cells to its cell-based screening services (Press release, Horizon Discovery, APR 3, 2020, View Source [SID1234556128]).

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Primary human cells, which are cells that are freshly isolated from donors, are known to be difficult to study in the lab. However, working with these cells brings scientists one step closer to healthy or diseased micro-environments, enabling them to better understand disease etiology and therapeutic mechanisms, and thereby advance drug discovery and development programs.

Horizon has already applied its gene editing and cell culture expertise to maintain the viability of primary human T cells to enable functional genomic screens and has been delivering data-rich information to customers working in drug discovery and development. The new B cell screening service, the first of its kind in the market, will enable researchers to identify genes that affect the function of B cells and examine how this impacts other immune cell types, particularly in infectious diseases, cancer, and auto-immune disorders, such as COVID-19, Burkitt’s lymphoma and multiple sclerosis respectively.

Terry Pizzie, CEO, Horizon Discovery said: "The interest in harnessing the immune system for effective therapies continues to grow, with the global cell therapy market predicted to reach $8.21bn by 2025*. Expanding our services to encompass screening of both primary T and B cells is another example of our commitment to apply decades of gene editing experience in support of drug discovery and development for the treatment of human disease."