On November 4, 2021 IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) ("IntelGenx"), a leader in pharmaceutical films, reported that it will release its third quarter 2021 financial results after market close on Thursday, November 11, 2021 (Press release, IntelGenx, NOV 4, 2021, View Source [SID1234594602]).

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An accompanying conference call will be hosted by Dr. Horst G. Zerbe, Chief Executive Officer, and Mr. Andre Godin, President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:

Third Quarter 2021 Results Conference Call Details:

Date: Thursday, November 11, 2021

Time: 4:30 p.m. ET

Live Call: 1-888-506-0058 (Canada and the United States)
1-973-528-0135 (International)

Access Code: 995615
The call will also be broadcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.

On November 4, 2021 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated therapeutics, reported third quarter 2021 financial results and provided a business update (Press release, CytomX Therapeutics, NOV 4, 2021, View Source [SID1234594601]).

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"With intense focus on execution, the CytomX team made significant progress with clinical site initiation and patient enrollment during the past quarter. As a result, we remain on track to announce initial data by year end from our ongoing Phase 2 expansion study evaluating CX-2029 in defined cancer types," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "We also remain on track for initial data from the praluzatamab ravtansine Phase 2 breast cancer clinical program in 2022. In addition, we are expanding the reach of our versatile platform with anticipated fourth quarter IND filing for our first conditionally activated T-cell bispecific antibody, CX-904, and with the presentation at SITC (Free SITC Whitepaper) 2021 of our emerging drug discovery work in the field of conditional cytokines," added Dr. McCarthy.

Third Quarter Business Highlights and Recent Developments

Clinical site activation and patient enrollment for the ongoing Phase 2 study of CytomX’s wholly owned conditional antibody-drug conjugate (ADC), praluzatamab ravtansine (CX-2009), made substantial progress, including opening additional sites in U.S., Europe, and Asia, as well as partnering with patient advocacy groups to encourage enrollment from underrepresented populations. Praluzatamab ravtansine is currently being evaluated in a Phase 2 study as monotherapy in patients with human epidermal growth factor receptor 2-non-amplified breast cancer and, in combination with pacmilimab (CX-072), in patients with triple-negative breast cancer. Initial data from this study is on track for 2022.
Patient enrollment into the expansion cohorts continued for the Phase 2 study of CX-2029, evaluating the CD71-directed conditionally activated ADC co-developed by CytomX and AbbVie in four cancer indications: squamous non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal and gastro-esophageal junction cancers, and diffuse large B-cell lymphoma. Initial data from this study is on track for the fourth quarter of 2021.
BMS-986249, a Probody version of ipilimumab, continued to be studied by Bristol Myers Squibb, CytomX’s collaboration partner, in combination with nivolumab, the anti-PD-1 antibody, across four different advanced malignancies: melanoma, hepatocellular carcinoma, castration-resistant prostate cancer, and triple-negative breast cancer. Bristol Myers Squibb is also evaluating BMS-986288, a Probody version of non-fucosylated ipilimumab, as monotherapy or in combination with nivolumab, in a Phase 1 study.
CytomX expects to submit an investigational new drug application for CX-904 to the U.S. Food and Drug Administration in late 2021. CX-904 is a conditionally activated T-cell-engaging bispecific antibody candidate against the epidermal growth factor receptor on tumor cells and CD3 on T cells and is partnered with Amgen.
A CytomX abstract highlighting company progress in the field of conditionally active cytokines has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting (SITC 2021), which will be held from November 12-14, 2021 at the Walter E. Washington Convention Center, Washington, DC. This presentation will detail the preclinical characterization and improved therapeutic index of a masked interferon alpha-2b (IFN-a2b) leveraging CytomX proprietary conditional activation technologies.
CytomX published a preclinical study in Cancer Immunology Research showing that systemic administration of conditionally activated anti-programmed cell death ligand 1 (anti-PD-L1) and anti-programmed cell death protein 1 (anti-PD-1) antibodies to tumor-bearing mice elicited antitumor activity similar to that of traditional PD-1/PD-L1-targeted antibodies, but with reduced systemic immune-mediated toxicity. These data provide further preclinical rationale to support the ongoing development of pacmilimab (CX-072), currently in a Phase 2 study in combination with praluzatamab ravtansine in patients with TNBC. The preclinical article can be accessed at View Source
CytomX appointed Alan Ashworth, Ph.D., FRS, a world-renowned expert in cancer research and a global leader in cancer therapy development, to its board of directors.
Third Quarter 2021 Financial Results
Cash, cash equivalents, and investments totaled $336 million as of September 30, 2021, compared to $316 million as of December 31, 2020.

Revenue was $18 million for the three months ended September 30, 2021, relatively flat when compared to the corresponding period in 2020.

Research and development expenses increased $5 million during the three months ended September 30, 2021 to $29 million compared to the corresponding period in 2020. The increase was driven mainly by personnel, clinical trial, and consulting and contract service expenses primarily related to praluzatamab ravtansine and CX-2029.

General and administrative expenses increased $2.5 million during the three months ended September 30, 2021 to $11 million compared to the corresponding period in 2020. The increase was attributable to personnel related and recruiting expenses as well as professional services.

Conference Call & Webcast
CytomX management will host a conference call and a simultaneous webcast today at 5:00 p.m. ET (2:00 p.m. PT) to discuss the financial results and provide a business update. To join the conference call, please dial (877) 809-6037 (domestic) or (615) 247-0221 (international) and reference the conference ID 3886792. A live webcast of the call can be accessed at the Events and Presentations page of CytomX’s website at View Source An archived replay of the webcast will be available on the Company’s website until November 11, 2021.

On November 4, 2021 Merus N.V. (Nasdaq: MRUS) ("Merus", the "Company," "we" and "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the launch of a proposed underwritten public offering of its common shares (the "Offer Shares") (Press release, Merus, NOV 4, 2021, View Source [SID1234594600]). All of the common shares are being offered by Merus. In addition, Merus expects to grant the underwriters a 30-day option to purchase an additional 15% of the Offer Shares (the "Option Shares" and together with the Offer Shares, the "Shares"). The offering is subject to market conditions and other closing conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Merus intends to use the net proceeds from the offering to advance the clinical development of its product candidates, for preclinical research and technology development, and for working capital and general corporate purposes.

Jefferies LLC and SVB Leerink LLC are acting as joint book-running managers for the offering. Kempen & Co is acting as lead manager for the offering. H.C. Wainwright & Co. and Roth Capital Partners are acting as co-managers for the offering.

The offering will be made pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission ("SEC") on May 7, 2021 and was effective upon filing. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, which, for the avoidance of doubt, will not constitute a "prospectus" for the purposes of (i) Regulation (EU) 2017/1129 (the "Prospectus Regulation") and has not been reviewed by any competent authority in any member state in the European Economic Area (the "EEA") and (ii) the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the "UK Prospectus Regulation") and has not been reviewed by the Financial Conduct Authority in the United Kingdom. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by phone at (877) 821-7388, or by email at [email protected] or SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

This press release is an advertisement and not a prospectus within the meaning of either the Prospectus Regulation or the UK Prospectus Regulation.

EEA:

In relation to each member state of the EEA (each, a "Relevant State"), no Shares have been offered or will be offered pursuant to the offering to the public in that Relevant State, other than:

to any legal entity which is a qualified investor as defined under Article 2 of the Prospectus Regulation;
to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the Prospectus Regulation), subject to obtaining the prior consent of the underwriters for any such offer; and
in any other circumstances falling within Article 1(4) of the Prospectus Regulation,
provided that no such offer of the Shares shall require us or any of our representatives to publish a prospectus pursuant to Article 3 of the Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the Prospectus Regulation and each person who initially acquires any Shares or to whom any offer is made will be deemed to have represented, acknowledged and agreed to and with each of the representatives and us that it is a "qualified investor" as defined in the Prospectus Regulation.

For the purposes of the above, the expression an "offer of shares to the public" in relation to any Shares in any Relevant State means the communication in any form and by means of sufficient information on the terms of the offer and the Shares to be offered so as to enable an investor to decide to purchase Shares.

United Kingdom:

No Shares have been offered or will be offered pursuant to this offering to the public in the United Kingdom prior to the publication of a prospectus in relation to the Shares which has been approved by the Financial Conduct Authority, except that the Shares may be offered to the public in the United Kingdom at any time:

a) to any legal entity which is a qualified investor as defined under Article 2 of the UK Prospectus Regulation;

b) to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the UK Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; or

c) in any other circumstances falling within Section 86 of the Financial Services and Markets Act 2000 (the "FSMA")

provided that no such offer of the Shares shall require us or any of our representatives to publish a prospectus pursuant to Section 85 of the FSMA or supplement a prospectus pursuant to Article 23 of the UK Prospectus Regulation.

For the purposes of this provision, the expression an "offer to the public" in relation to the Shares in the United Kingdom means the communication in any form and by any means of sufficient information on the terms of the offer and any Shares to be offered so as to enable an investor to decide to purchase or subscribe for any Shares.

In addition, in the United Kingdom, the transaction to which this press release relates will only be available to, and will be engaged in only with persons who are "qualified investors" (as defined in the UK Prospectus Regulation) (i) who have professional experience in matters relating to investments falling within Article 19(5) of the FSMA (Financial Promotion) Order 2005, as amended (the Order), and/or (ii) who are high net worth entities (or persons to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). In the United Kingdom, the securities referred to herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with relevant persons. Any person in the United Kingdom who is not a relevant person should not act or rely on this communication or any of its contents.

On November 4, 2021 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise, reported financial results for the third quarter and first nine months of 2021 (Press release, Prothena, NOV 4, 2021, View Source [SID1234594599]). In addition, the Company provided business highlights and updated 2021 financial guidance.

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"Prothena made significant progress across our portfolio in the third quarter. We presented scientific findings highlighting two of our potentially best-in-class Alzheimer’s disease programs and advanced our ongoing confirmatory Phase 3 trial of birtamimab in Mayo Stage IV patients with AL amyloidosis. Additionally, we announced the acquisition of our ATTR amyloidosis program by Novo Nordisk and executed the U.S. license agreement for our anti-tau targeting clinical candidate, PRX005, with Bristol Myers Squibb. Our strategic collaborations have continued to deliver value, contributing $140 million in partner payments this quarter," said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. "As we look ahead, we will continue to focus on driving meaningful growth across our broad portfolio to deliver transformational treatments for patients."

Third Quarter and Recent Business Highlights:

Birtamimab, a potential best-in-class amyloid depleter treatment for AL amyloidosis, is an investigational humanized monoclonal antibody designed to directly neutralize soluble toxic aggregates and promote clearance of amyloid that causes organ dysfunction and failure

Confirmatory Phase 3 AFFIRM-AL study of birtamimab in Mayo Stage IV patients with AL amyloidosis is ongoing (NCT#04973137)
PRX004, a potential first-in-class treatment for ATTR amyloidosis, is a humanized monoclonal antibody designed to deplete the pathogenic, non-native forms of the TTR protein, and is being developed by Novo Nordisk for the treatment of ATTR cardiomyopathy

Announced Novo Nordisk acquisition of ATTR amyloidosis business; Prothena is eligible to receive a total aggregate of up to $1.23 billion
Received $60 million upfront payment from Novo Nordisk to date
PRX005, a potential best-in-class treatment for Alzheimer’s disease (AD), is an investigational antibody that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in diseases including AD, frontotemporal dementia (FTD), progressive supranuclear palsy (PSP), chronic traumatic encephalopathy (CTE), and other tauopathies. PRX005 is part of the global neuroscience research and development collaboration with Bristol Myers Squibb

Received $80 million option payment from Bristol Myers Squibb for execution of U.S. license agreement
PRX012, a potential best-in-class treatment for AD, is an investigational high-potency monoclonal antibody targeting a key epitope at the N-terminus of amyloid beta (Aβ)

Presented preclinical results at the Alzheimer’s Association International Conference 2021 (AAIC) demonstrating that PRX012 significantly cleared both pyroglutamate-modified and -unmodified Aβ plaque in post-mortem brain tissue of late-stage AD patients
Dual Aβ-tau vaccine, a potential first-in-class prevention and treatment for AD, is a dual-target vaccine targeting key epitopes within the Aβ and tau proteins to promote amyloid clearance and blockade of pathogenic tau

AAIC presentation showcased preclinical data demonstrating that Prothena’s dual Aβ-tau vaccine generated appropriate and balanced antibody titers promoting both phagocytosis of Aβ plaque and blockade of tau transmission in vitro
Corporate

In October, the Company announced two executive appointments to support its transition to a fully integrated biotechnology company. Chief Financial Officer Tran Nguyen was appointed to the additional and newly created role of Chief Strategy Officer and Brandon Smith was appointed the role of Chief Operating Officer.
Key Upcoming Milestones:

PRX004

$40 million near-term clinical milestone payment from Novo Nordisk
PRX005

Potential $55 million option payment from Bristol Myers Squibb for global rights at the end of the ongoing Phase 1 study
PRX012

Investigational New Drug Application (IND) expected 1Q 2022
Dual Aβ-Tau vaccine

IND expected 2023
Upcoming Investor Conferences

Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:

Stifel 2021 Virtual Healthcare Conference, November 16, 2021, at 2:00 PM ET
Jefferies London Healthcare Conference, on demand presentations available starting November 18, 2021, at 8:00 AM GMT/3:00 AM ET
Piper Sandler 33rd Annual Healthcare Conference, on demand presentations available starting November 22 at 10:00 AM ET
Third Quarter and First Nine Months of 2021 Financial Results and Updated 2021 Financial Guidance

For the third quarter and first nine months of 2021, Prothena reported a net income of $109.2 million and $100.2 million, respectively, as compared to a net loss of $30.6 million and $80.4 million for the third quarter and first nine months of 2020, respectively. Net income per share on a diluted basis for the third quarter of 2021 and first nine months of 2021, was $2.13 and $2.12, respectively, as compared to net loss per share of $0.77 and $2.02 for the third quarter and first nine months of 2020, respectively.

Prothena reported total revenue of $139.2 million and $199.4 million for the third quarter and first nine months of 2021, respectively. Revenue for the third quarter included collaboration revenue of $78.5 million from Bristol Meyer Squibb for the option exercise and US license for PRX005 and intellectual property revenue of $60.7 million from the sale of the intellectual property and related rights to the Company’s ATTR amyloidosis business and pipeline to Novo Nordisk. In addition to third quarter 2021 revenue, the first nine months revenue included collaboration revenue of $60 million in clinical milestone payment from Roche for dosing of first patient in the global Phase 2b PADOVA study for prasinezumab and license revenue from Roche. This compares to total revenue of $0.2 million and $0.5 million for the third quarter and first nine months of 2020, primarily from collaboration revenue from Roche.

Research and development (R&D) expenses totaled $18.0 million and $60.2 million for the third quarter and first nine months of 2021, respectively, as compared to $21.6 million and $54.1 million for the third quarter and first nine months of 2020, respectively. The decrease in R&D expense for the third quarter, compared to the same period in the prior year was primarily due to lower manufacturing costs primarily related to PRX005 and birtamimab programs, lower collaboration expenses related to the prasinezumab program with Roche as a result of the cost share opt-out exercised in May 2021; offset in part by higher personnel related expenses and higher clinical trial expenses primarily related to birtamimab AFFIRM-AL trial and PRX005 program. The increase for the first nine months of 2021, compared to the same period the prior year was primarily due to higher personnel expenses, higher clinical trial expense primarily related to birtamimab AFFIRM-AL trial and PRX005 program (offset in part by lower PRX004 clinical trial expense) and higher R&D consulting expenses; offset in part by lower collaboration expenses related to the prasinezumab program with Roche as a result of the cost share opt-out exercised in May 202l and lower manufacturing expenses primary related to PRX005 and birtamimab programs.

R&D expenses included non-cash share-based compensation expense of $2.5 million and $6.6 million for the third quarter and first nine months of 2021, respectively, as compared to $2.1 million and $6.2 million for the third quarter and first nine months of 2020, respectively.

General and administrative (G&A) expenses totaled $12.0 million and $34.1 million for the third quarter and first nine months of 2021, respectively, as compared to $9.4 million and $28.8 million for the third quarter and first nine months of 2020, respectively. The increase in G&A expenses for the third quarter and first nine months of 2021 compared to the same period in the prior year was primarily related to higher personnel expense, higher legal expenses, higher consulting and higher expense for our director and officer insurance premium. G&A expenses included non-cash share-based compensation expense of $3.6 million and $11.1 million for the third quarter and first nine months of 2021, respectively, as compared to $3.5 million and $10.6 million for the third quarter and first nine months of 2020, respectively.

Total non-cash share-based compensation expense was $6.1 million and $17.8 million for the third quarter and first nine months of 2021, respectively, as compared to $5.6 million and $16.8 million for the third quarter and first nine months of 2020.

As of September 30, 2021, Prothena had $601.5 million in cash, cash equivalents and restricted cash and no debt.

As of October 28, 2021, Prothena had approximately 46.6 million ordinary shares outstanding.

The Company continues to expect the full year 2021 net cash provided by operating and investing activities to be $85 to $95 million. The Company is updating its projected year end cash balance to approximately $575 million in cash, cash equivalents and restricted cash (midpoint) (versus prior guidance of $491 million) to include net financing proceeds received in the third quarter of 2021. The estimated full year 2021 net cash provided by operating and investing activities is primarily driven by an estimated net income of $50 to $60 million, which includes an estimated $25 million of non-cash share-based compensation expense.

On November 4, 2021 NantHealth, Inc. (NASDAQ-GS: NH), a leading provider of enterprise solutions that help businesses transform complex data into actionable insights, reported that the company will participate at the 2021 Jefferies London Healthcare Conference (Press release, NantHealth, NOV 4, 2021, View Source [SID1234594598]).

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Management plans to host virtual one-on-one and small group meetings with institutional investors on November 18 and 19, 2021. For additional information or to schedule a meeting with NantHealth management, please contact your Jefferies representative.