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.

On November 4, 2021 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported its financial and operating results for the third quarter ended September 30, 2021 (Press release, AEterna Zentaris, NOV 4, 2021, View Source;id=215914&p=2209892&I=1206939-c7Z3G6f3m8 [SID1234594595]). The Company also provided an update on progress in its pre-clinical and clinical development programs.

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"Since January 2021, we have made a concerted effort to not only advance our clinical-stage program but to expand our development pipeline. We have delivered on that goal and are pleased with the progress made to date. The leadership and expertise we have established at Aeterna Zentaris, now coupled with a diversified portfolio of assets with the potential to address areas of significant medical need, has created an exciting time in the Company’s evolution and multiple potential avenues for value creation. We are diligently working to execute on the advancement of all our clinical and pre-clinical programs and are poised to continue building momentum and value in the near and long term," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna.

Recent Highlights:

Entered into an additional exclusive license with the Julius-Maximilians-University of Wuerzburg (the "University of Wuerzburg") for early pre-clinical development of AIM Biologics for the potential treatment of Parkinson’s disease.
Exercised its option under the agreement with the University of Wuerzburg to expand application of oral vaccine platform to second indication, chlamydia.
Pre-Clinical and Clinical Programs Update:

Diagnostics Development Pipeline

Macimorelin Diagnostic: Ghrelin agonist in development for diagnostic use in childhood-onset growth hormone deficiency ("CGHD")

Aeterna is currently conducting its pivotal Phase 3 safety and efficacy study AEZS-130-P02 (the "DETECT-trial") evaluating macimorelin for the diagnosis of CGHD. Children and adolescents from two to less than 18 years of age with suspected growth hormone deficiency are to be included. The study is expected to include approximately 100 subjects worldwide, with at least 40 subjects in pre-pubertal and 40 subjects in pubertal status. Macimorelin growth hormone stimulation test ("GHST") will be performed twice for repeatability data and two standard GHSTs will be used as controls: arginine (i.v.) and clonidine (p.o.). On April 22, 2021, the U.S. FDA Investigational New Drug Application associated with this clinical trial became active. The first clinical sites in the U.S. are open for patient recruitment. In the EU and rest of world countries, clinical trial approval procedures and site initiation activities are ongoing.

Next Steps

Conduct and complete the DETECT-trial.
Therapeutics and Vaccine Development Pipeline

AIM Biologicals: Targeted, highly specific autoimmunity modifying therapeutics for the potential treatment of neuromyelitis optica spectrum disorder ("NMOSD") and Parkinson’s disease (PD)

In January 2021, Aeterna entered into an exclusive patent license and research agreement with the University of Wuerzburg, Germany, for worldwide rights to develop, manufacture and commercialize AIM Biologicals for the potential treatment of NMOSD. Additionally, the Company has engaged Prof. Dr. Joerg Wischhusen of the University of Wuerzburg as well as neuro-immunologist Dr. Michael Levy (MGH/Boston) as consultants, who will provide scientific support and advice in the field of inflammatory CNS disorders, autoimmune diseases of the nervous system, and NMOSD.

In September 2021, the Company entered into an additional exclusive license with the University of Wuerzburg for early pre-clinical development for the potential treatment of Parkinson’s disease.

Next Steps – NMOSD

Conduct in-vitro and in-vivo assessments to select an AIM Biologicals-based development candidate.
Manufacturing process development for selected candidate.
Next Steps – Parkinson’s Disease

Design and produce antigen-specific AIM Biologics molecules for the potential treatment of Parkinson’s disease.
Conduct in-vitro and in-vivo assessments in relevant Parkinson’s disease models.
Macimorelin Therapeutic: Ghrelin agonist in development for the treatment of ALS (Lou Gehrig’s disease)

In January 2021, the Company entered into a material transfer agreement with the University of Queensland, Australia, to provide macimorelin for the conduct of pre-clinical and subsequent clinical studies evaluating macimorelin as a potential therapeutic for the treatment of ALS (Lou Gehrig’s disease). The University of Queensland researchers have filed for supportive grants and aim to conduct pre-clinical studies in multiple pre-clinical models to demonstrate the therapeutic reach of macimorelin on disease progression and disease-specific pathology. They also plan to conduct a subsequent investigator initiated clinical trial given positive pre-clinical results.

Macimorelin, a ghrelin agonist, is an orally active small molecule that stimulates the secretion of growth hormone from the pituitary gland. Acting via this mechanism, it is believed that macimorelin may slow the progression of certain neurodegenerative diseases like ALS.

Next Steps

Work with the University of Queensland to conduct proof-of-concept studies with macimorelin in disease-specific animal models.
Assess alternative formulations.
Formalize pre-clinical development plan.
Delayed Clearance Parathyroid Hormone ("DC-PTH") Fusion Polypeptides: Potential treatment for primary hypoparathyroidism

In March 2021, Aeterna entered into an exclusive patent and know-how license agreement and research agreement with The University of Sheffield, United Kingdom, for the intellectual property relating to DC-PTH fusion polypeptides with delayed clearance for all human uses. In consultation with The University of Sheffield, Aeterna has selected AEZS-150 as the lead candidate in its DC-PTH program. AEZS-150 is being developed with the goal of providing a potential new treatment option of primary hypoparathyroidism in adults.

Next Steps

Work with The University of Sheffield to conduct in depth characterization of development candidate (in-vitro and in-vivo).
Develop manufacturing process.
Formalized pre-clinical development of AEZS-150 in preparation for a potential IND filing for conducting the first in-human clinical study.
Vaccine Platform: Potential orally active, live-attenuated bacterial vaccine with application across multiple coronavirus types, including COVID-19 (SARS-CoV-2) and chlamydia

In February 2021, Aeterna entered into an exclusive option agreement with the University of Wuerzburg to evaluate a pre-clinical, potential COVID-19 vaccine developed at the University of Wuerzburg. In March 2021, the Company exercised its option and entered into a license agreement where the Company was granted an exclusive, world-wide, license to certain patent applications and know-how owned by the University of Wuerzburg to research and develop, manufacture, and sell a potential COVID-19 vaccine. The Company’s vaccine platform is currently undergoing pre-clinical studies for the prevention of coronavirus diseases, including COVID-19 (SARS-CoV-2) with the planned start of clinical development targeted for H1 2023.

In September 2021, the Company exercised its option under the agreement with the University of Wuerzburg on a then undisclosed field, now known to be chlamydia. Chlamydia trachomatis is a sexually transmitted bacterium infecting over 130 million subjects annually. Asymptomatic disease can spread to the reproductive tract eventually inducing infertility, miscarriage, or ectopic pregnancy, which is a life-threatening condition. Ocular infections can lead to inclusion conjunctivitis or trachoma, which is the primary source of visual impairment or infectious blindness.

Additionally, the Company has entered into a Research Agreement under which the Company has engaged the University of Wuerzburg on a fee-for-service basis to conduct supplementary research activities and pre-clinical development studies on the potential vaccines, the results of which will be included within the scope of the license agreements. Additionally, Prof. Dr. Thomas Rudel of the University of Wuerzburg was engaged by the Company in September 2021 as a scientific consultant to support development of the salmonella-based vaccine platform for the coronavirus and chlamydia vaccines.

Next Steps – Coronavirus Vaccine

Evaluate administration route, dose and immunization scheme.
In-vivo immunology experiments with antigen variant candidates in relevant mice models.
Conduct virus challenge experiments in immunized transgenic animals.
Start manufacturing process assessment / development.
Conduct pre-clinical safety and toxicology assessment.
Next Steps – Chlamydia Vaccine

Design and prepare candidate vaccine strains.
Evaluate administration route, dose and immunization scheme.
In-vivo immunology experiments with candidate strains in relevant mouse models.
Summary of Third Quarter 2021 Financial Results

All amounts in this press release are in U.S. dollars unless otherwise noted.

Financing and Warrant Exercises

During the period between January 1, 2021, and September 30, 2021, holders have exercised certain of our outstanding warrants to purchase 35,011,187 of the Company’s common shares for gross proceeds of approximately $20.0 million. On October 1, 2021, the Company received notice of exercise of 100,000 warrants at $0.45 per common share for the issuance of 100,000 common shares of the Company; such exercise was completed on October 4, 2021.

Cash and cash equivalents

The Company had $68.0 million in cash and cash equivalents at September 30, 2021 (June 30, 2021 – $69.9 million).

Results of operations for the three-month period ended September 30, 2021

For the three-month period ended September 30, 2021, the Company reported a consolidated net loss of $1.7 million, or $0.01 loss per common share (basic), as compared with a consolidated net loss of $1.1 million, or $0.02 loss per common share (basic) for the three-month period ended September 30, 2020. The $0.6 million increase in net loss is primarily from an increase in total operating expenses of $0.6 million and a decline in net finance income of $0.5 million, partially offset by an increase of $0.5 million in total revenue.

Revenues

Total revenue for the three-month period ended September 30, 2021, was $0.6 million as compared with $0.1 million for the same period in 2020, representing an increase of $0.5 million. 2021 revenue was comprised of $0.52 million in licensing revenue (2020 – $0.02 million), $0.06 million in supply chain revenue (2020 – $0.09 million) and $0.02 million in royalty income (2020 – $0.02 million).
Operating expenses

The Company’s total operating expenses for the three-month period ended September 30, 2021, were $2.4 million as compared with $1.9 million for the same period in 2020, representing an increase of $0.5 million. This increase arose primarily from a $0.4 million increase in research and development costs and an increase of $0.1 million in selling expenses. This increase in total operating expenses was primarily due to the impact of the initiation of research and development projects as announced in the first quarter of 2021.
Net finance income

Net finance income for the three-month period ended September 30, 2021, was $0.1 million as compared with net finance income of $0.6 million for the same period in 2020, representing a decrease in net finance income of $0.5 million. This was primarily due to the $0.8 million decrease in the change in fair value of the warrant liability and a $0.1 million decline in the gain from changes in foreign currency exchange rates partially offset by a $0.4 million reduction in other finance costs.
Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the third quarter of 2021, as well as the Company’s unaudited consolidated interim financial statements as of September 30, 2021, will be available on the Company’s website (www.zentaris.com) in the Investors section or at the Company’s profile at www.sedar.com and www.sec.gov.

On November 4, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), reported third quarter and year-to-date 2021 financial results and corporate updates (Press release, Iovance Biotherapeutics, NOV 4, 2021, View Source [SID1234594594]).

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Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "During 2021, we have continued to report long-term clinical data demonstrating the durability of one-time treatment with lifileucel in metastatic melanoma while broadening the potential for TIL cell therapy to address more patients in additional indications and treatment settings. We look forward to highlighting our TIL cell therapy platform at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting. Our top priority remains our ongoing work to address feedback from the U.S. Food and Drug Administration (FDA) regarding the potency assays for lifileucel to support our planned biologics license application (BLA) submission. We remain increasingly confident in the broad potential for TIL as the next class of paradigm-shifting therapy for cancer patients with significant unmet need."

Third Quarter 2021 Highlights and Recent Corporate Updates

Regulatory

Potency assays for lifileucel: Following FDA feedback regarding the potency assays for lifileucel, Iovance has continued ongoing work developing and validating its potency assays and has engaged in discussions with the FDA during the second half of 2021. The anticipated BLA submission for lifileucel continues to be planned for the first half of 2022. Resolution of the potency assay for lifileucel in melanoma is also a key step towards our regulatory plans in other indications.
U.S. FDA Fast Track designation for lifileucel in combination with pembrolizumab in metastatic melanoma: The FDA granted Fast Track designation for lifileucel in combination with pembrolizumab for the treatment of metastatic melanoma based on the unmet medical need and potential advantages for this combination over available care. Fast Track designation allows for potential Accelerated Approval and Priority Review as well as more frequent interactions with the FDA.
Clinical

TIL therapy in combination with pembrolizumab in advanced solid tumor cancers: Iovance is investigating TIL in combination with pembrolizumab in earlier treatment settings in metastatic melanoma, cervical cancer, non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinoma (HNSCC) patients who are naïve to therapy with immune checkpoint inhibitors (ICI). Data for certain indications for TIL in combination with pembrolizumab will be highlighted in an oral presentation at the upcoming SITC (Free SITC Whitepaper) annual meeting. Early clinical data previously presented in metastatic melanoma (ASCO 2021) and HNSCC (SITC 2020) suggest that the response rate for TIL in combination with pembrolizumab may be increased in patients who are ICI-naïve.
TIL therapy in NSCLC:
LN-145 clinical data in metastatic NSCLC (mNSCLC): Detailed results from Cohort 3B in the IOV-COM-202 study will be highlighted in a poster presentation at the SITC (Free SITC Whitepaper) annual meeting. As previously reported, clinical data for LN-145 showed a 21.4% overall response rate (ORR) and 64.3% disease control rate in heavily pretreated mNSCLC patients who received one or more prior systemic therapies, including anti-PD-1 therapy.
LN-145 in second-line mNSCLC: Enrollment is ongoing and more than 20 clinical sites are activated in the U.S. and Canada for the IOV-LUN-202 study of LN-145 in patients with mNSCLC.
Research

Iovance continues to advance the next generation of TIL and related therapies and technologies. Late preclinical programs in investigational new drug (IND)-enabling studies include a novel IL-2 analog (IOV-3001) as well as a genetically modified TIL (IOV-4001). IOV-4001 leverages TALEN technology licensed from Cellectis S.A. to inactivate PD-1 expression by the TIL product.
Iovance and the National Institutes of Health (NIH) extended their Cooperative Research and Development Agreement (CRADA) through August 2024. The CRADA focuses on emerging areas of translational and clinical research for TIL therapies.
Manufacturing

TIL manufacturing success: To date, more than 500 patients have been dosed with Iovance TIL products with more than a 90 percent manufacturing success rate.
Iovance Cell Therapy Center (iCTC): Clinical manufacturing of TIL commenced at the iCTC in September of 2021. Commercial manufacturing remains on track to commence with a potential regulatory approval. The iCTC achieved LEED Gold Certification through the U.S. Green Building Council (USGBC).
Corporate

Cash position of $660.8 million at September 30, 2021 is expected to be sufficient well into 2023.
A strong organization of more than 300 employees with an average of more than 3.5 years of cell therapy experience is in place to advance research, development, manufacturing, and commercial launch preparations.
Iovance continues to expand its intellectual property portfolio and currently owns more than 30 granted or allowed U.S. and international patents for TIL compositions and methods of treatment and manufacturing in a broad range of cancers. Iovance’s Gen 2 patent rights are expected to provide exclusivity through 2038. Iovance’s portfolio also includes patent applications and granted patents directed towards Gen 3 manufacturing, selected TIL products, stable and transient genetic TIL modifications, tumor digest and fragment compositions and methods (including cryopreservation), and combinations of checkpoint inhibitors and TIL products.
Third Quarter and Year-to-Date 2021 Financial Results

Iovance has $660.8 million in cash, cash equivalents, investments and restricted cash at September 30, 2021 compared to $635.0 million at December 31, 2020. The cash position is expected to be sufficient to fund current and planned operations well into 2023.

Jean-Marc Bellemin, Chief Financial Officer, stated, "With the continued strength of our balance sheet and focused investment on pipeline development and launch preparations, we are well positioned to execute our operating plan with no immediate need to raise additional capital. Following completion of the iCTC, we have also concluded our initial $85 million investment in constructing the facility."

Net loss for the third quarter ended September 30, 2021, was $86.1 million, or $0.55 per share, compared to a net loss of $58.6 million, or $0.40 per share, for the third quarter ended September 30, 2020. Net loss for the nine months ended September 30, 2021, was $242.9 million, or $1.60 per share, compared to a net loss of $191.2 million, or $1.41 per share, for the same period ended September 30, 2020.

Research and development expenses were $65.4 million for the third quarter ended September 30, 2021, an increase of $22.3 million compared to $43.1 million for the third quarter ended September 30, 2020. Research and development expenses were $183.4 million for the nine months ended September 30, 2021, an increase of $34.1 million compared to $149.3 million for the same period ended September 30, 2020.

The increase in research and development expenses in the third quarter 2021 over the prior year period was primarily attributable to an increase in costs associated with growth of the internal research and development team and increases in clinical trial costs and iCTC facility related costs. The increase in research and development expenses in the first nine months of 2021 over the prior year period was primarily attributable to growth of the internal research and development team and an increase in iCTC facility related costs.

General and administrative expenses were $20.9 million for the third quarter ended September 30, 2021, an increase of $5.0 million compared to $15.9 million for the third quarter ended September 30, 2020. General and administrative expenses were $59.8 million for the nine months ended September 30, 2021, an increase of $15.7 million compared to $44.1 million for the same period ended September 30, 2020.

The increases in general and administrative expenses in the third quarter and first nine months of 2021 compared to the prior year periods were primarily attributable to growth of the internal general and administrative team and higher stock-based compensation expenses.

Webcast and Conference Call

Iovance will host a conference call today at 4:30 p.m. ET to discuss the third quarter 2021 financial results and corporate updates. The conference call dial-in numbers are 1-(844) 646-4465 (domestic) or 1-(615) 247-0257 (international) and the access code is 7286232. The live webcast can be accessed in the Investors section of the company’s website at View Source The archived webcast will be available for a year in the Investors section at www.iovance.com.