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PULSE BIOSCIENCES, INC. ANNOUNCES RECORD DATE, SUBSCRIPTION PRICING,
AND EXPIRATION DATE FOR RIGHTS OFFERING AND EFFECTIVENESS OF ITS
REGISTRATION STATEMENT

On November 8, 2018 Pulse Biosciences, Inc. (Nasdaq: PLSE) ("Pulse Biosciences" or the "Company"), a novel medical therapy company bringing to market its proprietary CellFX Nano-Pulse Stimulation (NPS) platform, reported that it has set key dates and pricing structure for its previously announced rights offering of $45,000,000 of its common stock (Press release, Pulse Biosciences, NOV 8, 2018, View Source [SID1234531168]).

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Pulse Biosciences intends to issue non-transferable subscription rights to purchase shares of its common stock to common stockholders as of 5:00 p.m. Eastern Time on Monday November 19, 2018 (the "Record Date"). Any person who purchases shares prior to the Record Date will be deemed a holder of record with respect to those shares only if the transaction has settled by the Record Date. The standard settlement cycle in the United States is currently the trade date plus two business days. Investors wishing to participate in the Company’s offering are encouraged to contact their broker-dealer to ensure the settlement of transactions prior to the Record Date.

Following the Record Date, the Company intends to mail to stockholders of record on the Record Date a prospectus and related documents for use in exercising subscription rights. The subscription rights will expire and have no value if they are not exercised prior to 5:00 p.m. Eastern Time on Thursday December 6, 2018 (the "Expiration Date").

Pursuant to the rights offering, Pulse Biosciences is distributing, at no charge to the holders of its common stock, non-transferable subscription rights to purchase up to $45,000,000 of shares of its common stock at a subscription price per share equal to the lesser of (i) $13.33 per share, the closing price on November 7, 2018 (the "Initial Price") or (ii) the volume weighted average price (the "Alternate Price") of the Company’s common stock as calculated for the five-trading day period through and including the Expiration Date.

Stockholders wishing to exercise subscription rights must timely pay $13.33 per share, the Initial Price, for the number of shares of common stock they wish to acquire. If the Alternate Price is lower than the Initial Price on the Expiration Date, any excess subscription amounts paid by a subscribing holder will be applied towards the purchase of additional shares in the rights offering. Stockholders who fully exercise their basic subscription rights will be entitled to subscribe for additional shares that are not purchased by other stockholders, on a pro rata basis and subject to availability and ownership limitations.

Stockholders may exercise their subscription rights by delivering documentation of their subscription and payment in the manner specified in the prospectus relating to the rights offering. Beneficial stockholders (i.e. stockholders whose shares are in a brokerage account), should exercise their subscription rights as indicated in the instructions provided by their broker-dealer. Procedures and dates set-forth by broker-dealers may differ from those in offering documents. Investors wishing to participate in the Company’s offering are encouraged to contact their broker-dealer for further information.

Questions about the rights offering and requests for copies of the prospectus relating to the rights offering may be directed to Broadridge Corporate Issuer Solutions, Inc., the Company’s information and subscription agent for the rights offering, after the Record Date by calling (888) 789-8409 (toll-free) or by emailing [email protected].

PharmaMar announces that Zepsyre® (lurbinectedin) shows noteworthy clinical activity in metastatic breast cancer with mutations in BRCA 1/2

On November 8, 2018 Zepsyre (lurbinectedin), from PharmaMar (MSE:PHM), reported noteworthy clinical activity in patients with metastatic breast cancer that have mutations in the BRCA 1 and/or BRCA 2 genes (Press release, PharmaMar, NOV 8, 2018, View Source [SID1234531166]). This is the conclusion contained in the "The Lancet Oncology" and the "Journal of Clinical Oncology", in their September and November issues, respectively; both having published the positive results of PharmaMar’s phase II trial.

This trial intended to assess the clinical activity of lurbinectedin in patients affected by metastatic breast cancer in BRCA 1 and/or BRCA 2 gene mutations. It is important to highlight that in the patients with BRCA2 mutations, the confirmed overall response rate (ORR) was observed to be 61%, the median progression-free survival (PFS) was observed to be 5.9 months and the median overall survival (OS) was observed to be 26.6 months.

In the prior, untreated PARP population, the confirmed ORR was 72%, this being the highest reported figure in this tumor setting so far. The 54 breast cancer patients with mutations in the BRCA 1 and/or BRCA 2 genes
included in the trial were recruited from 11 research centers in the United States and Spain.

"Lurbinectedin is a selective inhibitor of active transcription of protein-coding genes," explained by Judith Balmaña (Vall d’Hebron Institute of Oncology) in The Lancet Oncology. "In this phase II trial, it showed a notable efficacy in patients with metastatic breast cancer and a germline BRCA1/2 mutation."

Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction

Tocagen Reports Third Quarter 2018 Financial and Business Results

On November 8, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported financial results and business highlights for the third quarter ended September 30, 2018 (Press release, Tocagen, NOV 8, 2018, View Source;p=RssLanding&cat=news&id=2376312 [SID1234531164]).

"We conclude the eventful third quarter of 2018 having met important milestones, including early completion of enrollment and the first interim analysis of our ongoing Phase 3 Toca 5 trial. We’ve also further improved our balance sheet to advance our lead program and execute against our goals," said Marty Duvall, chief executive officer of Tocagen. "With the planned second interim and final analyses for Toca 5 anticipated in 2019, we are preparing for a potential rolling BLA submission and planning for commercial launch."

Third Quarter 2018 and Recent Highlights

First interim analysis of Toca 5 Phase 3 trial: In August 2018, Tocagen announced the Toca 5 pivotal Phase 3 trial evaluating Toca 511 (vocimagene amiretrorepvec) & Toca FC (extended-release flucytosine) in patients with recurrent high grade glioma (rHGG) will continue without modification following a pre-planned first interim analysis of data. An Independent Data Monitoring Committee completed its analysis at 50% of events occurring in the trial and recommended the trial continue without modification. Tocagen estimates the second interim analysis, at 75% of events in the trial, will occur in the first half of 2019 and that the final analysis will occur by the end of 2019.
Completed Toca 5 enrollment: In September 2018, Tocagen completed the planned enrollment of 380 patients in the ongoing Toca 5 Phase 3 trial approximately three months ahead of schedule.
Received milestone payment from ApolloBio: Completing the Toca 5 enrollment triggered a milestone payment of $2 million from ApolloBio, Tocagen’s licensee of Toca 511 & Toca FC within the greater China region.
Initiated commercial organization buildout: In September 2018, Mohamed Ladha joined Tocagen as vice president, head of commercial. Mr. Ladha will build, oversee and execute the global commercial strategies for Tocagen’s oncology products upon regulatory approval in the United States and other key markets.
Presented Toca 6 data: Tocagen presented new clinical data on Toca 511 & Toca FC in advanced solid tumors at the International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in late September. Data showed favorable safety, vector deposition in "hot" and "cold" tumors and immune changes consistent with preclinical and clinical observations. Based on these data, Tocagen is now planning future safety and efficacy trials in select tumor types.
Publication of Toca 511 & Toca FC data: In October 2018, two peer-reviewed clinical data manuscripts appeared in print related to Toca 511 & Toca FC in rHGG. Data published by Timothy F. Cloughesy and co-authors in Neuro-Oncology demonstrated multiyear durable responses observed in rHGG patients treated in a Toca 511 & Toca FC Phase 1 trial. Data published by Daniel J. Hogan and co-authors in Clinical Cancer Research demonstrated Toca 511 & Toca FC treatment was not associated with concerning integration sites and clonal expansion. These manuscripts first published online May 12, 2018 and June 26, 2018, respectively.
Third Quarter 2018 Financial Results

License Revenue: License revenue was $18.0 million for the quarter ended September 30, 2018, compared to less than $0.1 million for the quarter ended September 30, 2017. The 2018 revenue was associated with a $16.0 million upfront payment recognized under Tocagen’s license agreement with ApolloBio and a $2.0 million development milestone earned upon completion of enrollment in the Toca 5 clinical study.

Research and Development (R&D) Expenses: R&D expenses were $12.3 million for the quarter ended September 30, 2018, compared to $7.6 million for the quarter ended September 30, 2017. The increase in R&D expenses in 2018 was primarily driven by higher costs to support the expanded Toca 5 Phase 3 clinical study and manufacturing activities related to Toca 511.

General and Administrative (G&A) Expenses: G&A expenses were $4.3 million for the quarter ended September 30, 2018, compared to $2.2 million for the quarter ended September 30, 2017. The increase in G&A expenses was primarily due to foreign non-income tax expense of approximately $1 million paid under Tocagen’s license agreement with ApolloBio and an increase in non-cash stock-based compensation expense.

Net Loss: Net loss was $0.4 million, or $0.02 per common share (basic and diluted), for the quarter ended September 30, 2018, compared to a net loss of $10.0 million, or $0.50 per common share (basic and diluted), for the quarter ended September 30, 2017. The reduction in net loss in 2018 was due to $18.0 million in revenue recognized under Tocagen’s license agreement with ApolloBio. Tocagen recognized $1.5 million in income taxes for the quarter ended September 30, 2018 related to the license agreement with ApolloBio. The 2018 calculation is based on 20.0 million average common shares outstanding for the third quarter of 2018, compared to 19.8 million average shares outstanding for the third quarter of 2017.

2018 Nine-Month Results

License Revenue: License revenue was $18.0 million for the nine months ended September 30, 2018, compared to less than $0.1 million for the nine months ended September 30, 2017. The 2018 revenue was associated with a $16.0 million upfront payment recognized under Tocagen’s license agreement with ApolloBio and a $2.0 million development milestone earned upon completion of enrollment in the Toca 5 clinical study.

R&D Expenses: R&D expenses were $35.5 million for the nine months ended September 30, 2018 compared to $20.8 million for the nine months ended September 30, 2017. Similar to the third quarter results, the R&D expenses primarily reflect increased costs to support the expanded Toca 5 Phase 3 clinical study, manufacturing activities related to Toca 511 & Toca FC and personnel and related costs due to increased headcount.

G&A Expenses: G&A expenses were $9.3 million for the nine months ended September 30, 2018 compared to $6.2 million for the nine months ended September 30, 2017. Similar to the third quarter results, the G&A expenses primarily reflect the foreign non-income tax expense paid under Tocagen’s license agreement with ApolloBio and an increase in non-cash stock-based compensation expense.

Net Loss: Net loss for the nine months ended September 30, 2018 was $29.4 million, or $1.47 per common share (basic and diluted), compared to a net loss of $28.1 million, or $2.19 per common share (basic and diluted), for the nine months ended September 30, 2017. This calculation is based on 19.9 million average common shares outstanding for the nine months ended September 30, 2018, compared to 12.8 million average shares outstanding for the same period in 2017.

Cash Position and Guidance
Cash, cash equivalents and marketable securities were $79.8 million at September 30, 2018 compared to $88.7 million at December 31, 2017. Tocagen refined its annual cash burn guidance and estimates the total cash used in 2018 to fund operations and capital expenditures will be approximately $50 million, resulting in a year-end cash balance of approximately $70 million, up from approximately $40 million implied in guidance provided in January 2018.

About Toca 511 & Toca FC
Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511, and an investigational small molecule, Toca FC. Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, only infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.

Thermo Fisher Scientific Declares Quarterly Dividend

On November 8, 2018 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that its Board of Directors has declared a quarterly cash dividend of $0.17 per common share, payable on January 15, 2019, to shareholders of record as of December 17, 2018 (Press release, Thermo Fisher Scientific, NOV 8, 2018, View Source [SID1234531163]).

AnaptysBio Announces Third Quarter 2018 Financial Results and Provides
Pipeline Updates

On November 8, 2018 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, reported operating results for the third quarter ended September 30, 2018 and provided pipeline updates (Press release, AnaptysBio, NOV 8, 2018, View Source [SID1234531162]).

"We continued to advance the clinical development of our wholly-owned etokimab and ANB019 programs for severe inflammatory disease indications during the third quarter of 2018," said Hamza Suria, president and chief executive officer of AnaptysBio. "Top-line data from our etokimab Phase 2a trial in severe adult eosinophilic asthma patients demonstrated rapid and sustained improvement in Forced Exhaled Volume In One Second versus placebo, with corresponding reduction in blood eosinophil levels. We look forward to further advancement of our wholly-owned pipeline with four additional readouts from ongoing clinical trials of etokimab and ANB019 during 2019."

Etokimab (ANB020 Anti-IL-33 Program)
•
In September, the Company announced positive topline proof-of-concept data for etokimab, its investigational anti-IL-33 therapeutic antibody, in an ongoing single dose Phase 2a clinical trial in adult patients with severe eosinophilic asthma. Patients administered with etokimab rapidly improved their Forced Exhaled Volume In One Second, or FEV1, which is a measure of lung function, with an eight percent FEV1 improvement over placebo at Day 2. FEV1 improvement was sustained through Day 64, with an 11 percent increase over placebo. Blood eosinophil reduction was sustained through the interim analysis period, with a 31 percent reduction at Day 2 and a 46 percent reduction at Day 64 over placebo, which was consistent with FEV1 improvement observed in this trial. Etokimab was generally well tolerated in all patients and no serious adverse events were reported as of this interim analysis. This Phase 2a trial is currently ongoing and the company plans to report full data from this trial at a medical conference in 2019 following trial completion. AnaptysBio plans to continue development of etokimab in eosinophilic asthma with a multi-dose Phase 2b randomized, double-blinded, placebo-controlled trial, which is expected to be initiated in 2019.
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The Company is enrolling a Phase 2b randomized, double-blinded, placebo-controlled, multi-dose study in 300 adult patients with moderate-to-severe atopic dermatitis, also referred to as the ATLAS clinical trial, to assess different dose levels and dosing frequencies of subcutaneously-administered etokimab for a 16-week treatment period followed by an eight-week monitoring period, with data expected in the second half of 2019.
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The Company has cleared an IND and initiated a randomized, placebo-controlled Phase 2 trial, also referred to as the ECLIPSE trial, in approximately 100 adult patients with chronic rhinosinusitis with nasal polyps. Patients will be treated with two multi-dosing frequencies of subcutaneous-administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy, for a treatment period of 16 weeks followed by an eight-week monitoring period. The Company anticipates top-line data from the ECLIPSE trial will be available in the second half of 2019.

ANB019 (Anti-IL-36 Receptor Program)
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AnaptysBio has initiated a 10-patient, single arm, open-label Phase 2 trial of ANB019 in generalized pustular psoriasis, or GPP, also known as the GALLOP trial, and top-line data are anticipated in mid-2019.

All patients will be treated with an intravenous loading dose of ANB019 upon enrollment, followed by subcutaneously-administered monthly doses of ANB019 for a treatment period of up to 16 weeks post enrollment and followed by an eight-week monitoring period.
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AnaptysBio has cleared an IND with the FDA and has initiated a randomized, placebo-controlled 50-patient multi-dose Phase 2 trial in palmoplantar pustulosis, or PPP, also known as the POPLAR trial, where top line data are anticipated in the second half of 2019. Patients will be treated with a (i) a subcutaneously-administered loading dose of ANB019 upon enrollment, followed by subcutaneously-administered monthly doses of ANB019, or (ii) placebo, each for a treatment period of 16 weeks post enrollment and followed an eight-week monitoring period.
Corporate Highlights
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On September 28, 2018, the Company completed an underwritten public offering of 2,530,000 shares of common stock at a price to the public of $94.46, which included the exercise by the underwriters of their option to purchase an additional 330,000 shares of common stock. AnaptysBio, received net proceeds from the offering of $227.5 million, after deducting underwriting discounts and commissions.
Third Quarter Financial Results
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Cash, cash equivalents and investments totaled $512.4 million as of September 30, 2018 compared to $324.3 million as of December 31, 2017, for an increase of $188.1 million. The increase primarily relates to net proceeds received by the Company of $227.5 million from the public offering, offset by operating cash outflow for clinical and manufacturing related expenses, as well as personnel costs.
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Collaboration revenue was $5.0 million for the three and nine months ended September 30, 2018, related to a milestone for the first Phase 3 trial of TSR-042 by TESARO compared to no revenue and $7.0 million for two TESARO milestones for the three and nine months ended September 30, 2017, respectively.
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Research and development expenses were $17.9 million for the three months ended September 30, 2018, as compared to $6.7 million for the three months ended September 30, 2017. The increase was primarily due to continued advancement of the Company’s etokimab and ANB019 clinical programs and additional personnel-related expenses including share based compensation during the three months ended September 30, 2018.
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General and administrative expenses were $4.0 million for the three months ended September 30, 2018, as compared to $2.4 million for the three months ended September 30, 2017. The increase was primarily attributable to additional personnel-related expenses, including share based compensation, to support the Company’s growth.

Financial Guidance
AnaptysBio expects that its cash, cash equivalents and investments will fund its current operating plan at least through the end of 2020.
About Etokimab
Etokimab, previously referred to as ANB020, is an antibody that potently binds and inhibits the activity of interleukin-33, or IL-33, a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, which AnaptysBio believes is broadly applicable to the treatment of atopic inflammatory disorders, such as atopic dermatitis, eosinophilic asthma, chronic rhinosinusitis with nasal polyps, or CRSwNP, and potentially other allergic conditions. Following completion of a healthy volunteer Phase 1 trial of etokimab, AnaptysBio continued clinical development of etokimab into a Phase 2a trial for moderate-to-severe adult atopic dermatitis and a placebo-controlled Phase 2a trial in severe adult eosinophilic asthma patients. AnaptysBio is enrolling its ATLAS trial, a randomized, double-blinded, placebo-controlled multi-dose Phase 2b clinical trial of etokimab in 300 moderate-to-severe adult atopic dermatitis patients where data is anticipated in the second half of 2019. The company has also initiated its ECLIPSE trial, a randomized, double-blinded, placebo-

controlled Phase 2 trial of etokimab in approximately 100 adult patients with CRSwNP with data anticipated in the second half of 2019. AnaptysBio also plans to initiate a randomized, double-blinded, placebo-controlled, multi-dose Phase 2b trial of etokimab in patients with eosinophilic asthma in 2019.
About ANB019
ANB019 is an antibody that inhibits the function of the interleukin-36-receptor, or IL-36R, which AnaptysBio plans to initially develop as a potential first-in-class therapy for patients suffering from generalized pustular psoriasis, or GPP and palmoplantar pustulosis, or PPP. AnaptysBio conducted a Phase 1 clinical trial in healthy volunteers, where 54 subjects are dosed with ANB019 and 18 are dosed with placebo in single and multi-dose cohorts at various subcutaneous and intravenously administered dose levels. In May 2018, AnaptysBio presented data from this Phase 1 clinical trial, which demonstrated favorable safety, pharmacokinetics and pharmacodynamic properties that support advancement of ANB019 into Phase 2 studies. AnaptysBio is enrolling its GALLOP trial, a Phase 2 study of ANB019 in GPP where data is anticipated in the second quarter of 2019, and have initiated its POPLAR trial, a Phase 2 study in PPP where data is anticipated in the second half of 2019.