On November 4, 2021 Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious rare diseases, reported its third quarter 2021 financial results and provided a business update (Press release, Eiger Biopharmaceuticals, NOV 4, 2021, View Source [SID1234594620]).

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"The recent completion of enrollment in our Phase 3 HDV D-LIVR study of Lonafarnib-based regimens sets up pivotal topline data by the end of 2022," said David Cory, President and CEO. "Additionally, our Phase 3 HDV LIMT-2 study of Peginterferon Lambda is now activating sites and screening patients. Eiger is focused on the development of treatments and a cure for HDV. We are positioned to be a leader in this space with two first-in-class therapies for HDV, offering hope for the over 12 million patients around the globe with this devastating disease."

Program Updates and Upcoming Milestones

HDV Platform

Lonafarnib for HDV

First-in-class prenylation inhibitor and only oral agent in development
D-LIVR, largest Phase 3 global study conducted in HDV
Fully enrolled with over 400 patients
Opportunity for approval of two Lonafarnib-based regimens:
All-oral and combination with peginterferon alfa
Pivotal topline data planned by end of 2022
Peginterferon Lambda for HDV

Well-tolerated interferon administered as a weekly subcutaneous injection
LIMT-2 (N=150), pivotal study of Peginterferon Lambda monotherapy
Now activating sites and screening patients
Avexitide for Rare Metabolic Disorders

Phase 3 studies for post-bariatric hypoglycemia and congenital hyperinsulinism could begin as early as 2022
Zokinvy for Progeria and Processing-Deficient Progeroid Laminopathies

MAA is under EMA review, with an opinion from the Committee for Medicinal Products for Human Use (CHMP) expected around end of 2021
Cohort ATU program (Temporary Use Authorization) approved in France
First ATU shipment completed
Peginterferon Lambda for COVID-19

Phase 3 TOGETHER study enrolling patients across clinical sites in Brazil
DSMB interim futility analysis (n=453) recommended study continuation
Next interim futility data analysis by end of 2021
Positive data could support emergency use authorization package
Corporate

Appointed Erik Atkisson General Counsel and Chief Compliance Officer
Cash and investments of $120.4 million at the end of third quarter 2021 expected to fund planned operations into fourth quarter 2023
Third Quarter Financial Results

Net revenues from Zokinvy product sales were $3.0 million for third quarter 2021, as compared to $2.1 million for second quarter 2021. The increase was primarily driven by modestly higher inventory on-hand at the specialty pharmacy. The company commercially launched Zokinvy in the U.S. in January 2021 and has reported September year-to-date net sales of $8.8 million.

Cost of Sales were $0.3 million for third quarter 2021 and is related to certain costs associated with Zokinvy that were incurred after FDA approval.

Research and Development expenses were $18.1 million for third quarter 2021, as compared to $9.8 million for the same period in 2020. The increase was primarily due to clinical trial related expenses, including contract manufacturing and headcount related expenses, including stock-based compensation expense.

Selling, General and Administrative expenses were $6.5 million for the third quarter of 2021, as compared to $5.0 million for the same period in 2020. The increase was primarily due to outside consulting and advisory services and headcount related expenses, including stock-based compensation expense.

Total operating expenses include non-cash expenses of $3.0 million for the third quarter of 2021, as compared to $1.9 million for the same period in 2020.

Eiger reported a third quarter 2021 net loss of $22.2 million, or $0.65 on a per share basis. This compares to a net loss of $15.7 million, or $0.52 on a per share basis, for the third quarter of 2020.

Cash, cash equivalents, and investments as of September 30, 2021, totaled $120.4 million compared to $139.8 million as of June 30, 2021.

As of September 30, 2021, the company had 33,975,800 common shares outstanding.

Conference Call
At 4:30 PM Eastern Time today, November 4, 2021, Eiger will host a conference call to discuss its financial results and provide a business update. The live and replayed webcast of the call will be available through the company’s website at www.eigerbio.com. To participate in the live call by phone, dial (844) 743-2495 (U.S.) or (661) 378-9529 (International) and enter conference ID 9874006. The webcast will be archived and available for replay for at least 90 days after the event.

On November 4, 2021 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the third quarter ended September 30, 2021 (Press release, ViewRay, NOV 4, 2021, View Source [SID1234594618]).

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Third Quarter 2021 Highlights

Received seven new orders for MRIdian systems totaling $39.4 million, compared to four new orders totaling $23.4 million in the third quarter of 2020. Total orders for the nine months ended September 30, 2021 represent a 24% growth over total orders for the twelve months ended December 31, 2020.
Total backlog increased to $295.1 million as of September 30, 2021, compared to $238.9 million as of September 30, 2020.
Total revenue of $19.2 million primarily from three revenue units, compared to $10.1 million primarily from one revenue unit in the third quarter of 2020.
Cash usage in the third quarter of 2021 was approximately $17.0 million compared to approximately $16.0 million in the third quarter of 2020.
Cash and cash equivalents were $149.9 million as of September 30, 2021.
"Performance continues to be strong and momentum in our clinical and innovation pipelines are evident." said Scott Drake, President and CEO. "We had a great showing at ASTRO. Data presented by Dr. Michael Chuong on 148 inoperable pancreatic cancer patients with MRIdian SMART displayed 26 month median survival compared to 12-15 months typically seen in patients receiving chemotherapy and standard radiation therapy. Our technical lead should be extended with multiple enhancements pending with the FDA. The future is bright for patients treated on MRIdian."

Three Months Ended September 30, 2021 Financial Results

Total revenue for the three months ended September 30, 2021 was $19.2 million compared to $10.1 million for the same period last year.

Total gross profit (loss) for the three months ended September 30, 2021 was $1.9 million, compared to $(1.1) million for the same period last year.

Total operating expenses for the three months ended September 30, 2021 were $25.2 million, compared to $23.9 million for the same period last year.

Net loss for the three months ended September 30, 2021 was $25.3 million, or $0.15 per share, compared to $28.1 million, or $0.19 per share, for the same period last year.

ViewRay had total cash and cash equivalents of $149.9 million at September 30, 2021.

Nine Months Ended September 30, 2021 Financial Results:

Total revenue for the nine months ended September 30, 2021 was $49.7 million compared to $38.6 million for the same period last year.

Total gross profit (loss) for the nine months ended September 30, 2021 was $0.5 million, compared to $(4.2) million for the same period last year.

Total operating expenses for the nine months ended September 30, 2021 were $75.0 million, compared to $76.4 million for the same period last year.

Net loss for the nine months ended September 30, 2021 was $83.0 million, or $0.51 per share, compared to $81.8 million, or $0.55 per share, for the same period last year.

Financial Guidance

The Company reiterated its 2021 guidance of total revenue in the range of $63 million to $73 million, and total cash usage to be in the range of $58 million to $68 million.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Thursday, November 4, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The confirmation number is 5970168. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available for seven days after the call. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 5970168.

On November 4, 2021 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical Company focused on oncology, reported an oral presentation and three poster presentations at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, which is being held December 11-14, 2021 in Atlanta, GA, and virtually (Press release, BioLineRx, NOV 4, 2021, View Source [SID1234594379]).

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The oral presentation will elaborate on the successful results of the Company’s GENESIS Phase 3 pivotal trial. The study showed highly significant and clinically meaningful results supporting the use of Motixafortide on top of G-CSF for mobilization of stem cells for subsequent collection and transplantation in patients with multiple myeloma. In addition, the poster presentations will show that extended inhibition of the CXCR4 receptor by Motixafortide results in the mobilization of high numbers of stem cells, including specific sub-populations, which were correlated with reduced time to engraftment when infused in high numbers.

The Company is also presenting findings from in-vivo and in-vitro pre-clinical studies demonstrating that Motixafortide acts as an immunomodulator by affecting the biology of regulatory T cells (Tregs), supporting biomarker findings from the Company’s COMBAT Phase 2 study in pancreatic cancer patients.

"We are very pleased with the breadth of our oral and poster presentations at this year’s ASH (Free ASH Whitepaper) meeting, which reflect the versatility of Motixafortide as the potential backbone of promising new treatments for both hematological and solid tumor cancers," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Of particular note is the oral presentation on the outstanding results from our GENESIS Phase 3 pivotal study in stem cell mobilization demonstrating that Motixafortide effectively mobilizes a high number of cells enabling ~90% of patients to undergo transplantation following a single administration of Motixafortide and a single apheresis session. In addition, the high number of cells mobilized by Motixafortide enables infusion of an optimal number of cells, which could result in faster time to engraftment, and also allows for cryopreservation for future transplantation(s). These results, together with our recently completed successful pharmacoeconomic study, strongly support our view that Motixafortide on top of G-CSF can become the new standard of care in SCM, if approved, to the benefit of patients and payers alike. We look forward to submitting an NDA in the first half of next year, as previously communicated."

Further details of the presentations are provided below.

Oral Presentation

Title: Motixafortide (BL-8040) and G-CSF Versus Placebo and G-CSF to Mobilize Hematopoietic Stem Cells for Autologous Stem Cell Transplantation in Patients with Multiple Myeloma: The GENESIS Trial

Date: Sunday, December 12, 2021

Time: 12:00 PM

Location: Georgia World Congress Center, Hall A1

This oral presentation describes the GENESIS Phase 3 pivotal trial design, endpoints and results. The GENESIS study was a double blind, placebo controlled, multicenter trial, in which 122 patients were randomized (2:1) to receive either Motixafortide + G-CSF or placebo + G-CSF for stem cell mobilization prior to stem cell transplant in multiple myeloma patients. Total CD34+ cells/kg were analyzed on site to determine if patients mobilized to the goal and all samples were subsequently sent for assessment by a central laboratory. The number of CD34+ cells infused was determined independently by each investigator according to local practice.

The study concluded that a single administration of Motixafortide on top of G-CSF significantly increased the proportion of patients mobilizing ≥6×106 CD34+ cells/kg for stem cell transplantation (92.5%) vs G-CSF alone (26.2%) in up to two apheresis days (p<0.0001), while enabling 88.8% to collect ≥6×106 CD34+ cells/kg in just one apheresis day (vs 9.5% with G-CSF alone; p<0.0001). In addition, the median number of hematopoietic stem cells mobilized in one apheresis day with Motixafortide + G-CSF was 10.8×106 CD34+cells/kg vs 2.1×106 CD34+ cells/kg with G-CSF alone.

Poster Presentations

Title: Autologous Hematopoietic Cell Transplantation with Higher Doses of CD34+ Cells and Specific CD34+ Subsets Mobilized with Motixafortide and/or G-CSF is Associated with Rapid Engraftment – A Post-hoc Analysis of the GENESIS Trial

Date: Sunday, December 12, 2021

Time: 6:00 PM – 8:00 PM

The CD34+ hematopoietic stem and progenitor cell (HSPC) dose infused during stem cell transplantation remains one of the most reliable clinical parameters to predict quality of engraftment. A minimum stem cell dose of 2-2.5×106 CD34+ cells/kg is considered necessary for reliable engraftment, while optimal doses of 5-6×106 CD34+ cells/kg are associated with faster engraftment, as well as fewer transfusions, infections, and antibiotic days.

An analysis was performed using pooled data from all patients in the GENESIS trial to evaluate time to engraftment based on the total number of CD34+ cells/kg infused, as well as specific numbers of CD34+ cell sub-populations infused.

The addition of Motixafortide to G-CSF enabled significantly more CD34+ cells to be collected in one apheresis (median 10.8×106 CD34+ cells/kg) compared to G-CSF alone (2.1×106 CD34+ cells/kg), as well as 3.5-5.6 fold higher numbers of hematopoietic stem cells (HSCs), multipotent progenitors (MPPs), common myeloid progenitors (CMPs) and granulocyte and macrophage progenitors (GMPs) (all p-values <0.0004). A dose response was observed with a significant correlation between faster time to engraftment and infusion of higher number of total CD34+ HSPC doses (≥6×106 CD34+ cells/kg) and combined HSC, MPP, CMP and GMP subsets. The high number of CD34+ cells/kg mobilized with Motixafortide on top of G-CSF enables the potential infusion of ≥6×106 CD34+ cells/kg, as well as cryopreservation of cells for later use.

Title: Immunophenotypic and Single-Cell Transcriptional Profiling of CD34+ Hematopoietic Stem and Progenitor Cells Mobilized with Motixafortide (BL-8040) and G-CSF Versus Plerixafor and GCSF Versus Placebo and G-CSF: A Correlative Study of the GENESIS Trial

Date: Monday, December 13, 2021

Time: 6:00 PM – 8:00 PM

CD34 expression remains the most common immunophenotypic cell surface marker defining human hematopoietic stem and progenitor cells (HSPCs). The addition of CXCR4 inhibitors to G-CSF has increased mobilization of CD34+ HSPCs for stem cell transplantation; yet the effect of CXCR4 inhibition, with or without G-CSF, on mobilization of specific immunophenotypic and transcriptional CD34+ HSPC subsets is not well-characterized.

Motixafortide is a novel cyclic peptide CXCR4 inhibitor with a low receptor-off rate and extended in vivo action when compared to plerixafor. GENESIS Phase 3 trial patients were prospectively randomized (2:1) to receive either Motixafortide + G-CSF or placebo + G-CSF for HSPC mobilization. Demographically similar multiple myeloma patients undergoing mobilization with plerixafor + G-CSF prior to stem cell transplant were prospectively enrolled in a separate tissue banking protocol.

Extended CXCR4 inhibition with Motixafortide + G-CSF mobilized significantly higher numbers of combined CD34+ HSCs, MPPs and CMPs compared to plerixafor + G-CSF or G-CSF alone (p<0.05). Additionally, Motixafortide + G-CSF mobilized a 10.5 fold higher number of immunophenotypically primitive CD34+ HSCs capable of broad multilineage hematopoietic reconstitution compared to G-CSF alone (p<0.0001) and similar numbers compared to plerixafor + G-CSF. Furthermore, lack of CXCR4 inhibition resulted in mobilization of more-differentiated HCSs, whereas extended CXCR4 inhibition with Motixafortide + G-CSF (but not plerixafor + G-CSF) mobilized a unique MPP-III subset expressing genes specifically related to leukocyte differentiation.

Title: The High Affinity CXCR4 Inhibitor, BL-8040, Impairs the Infiltration, Migration, Viability and Differentiation of Regulatory T Cells

Date: Sunday, December 12, 2021

Time: 6:00 PM – 8:00 PM

This poster describes results of pre-clinical in-vivo and in-vitro studies demonstrating that Motixafortide potentially acts as an immunomodulator by affecting the biology of regulatory T cells. Motixafortide reduced the amount of infiltrating Tregs into the tumors, impaired the migration of Tregs toward CXCL12 and induced Tregs cell death. Furthermore, Motixafortide was found to inhibit the differentiation of naïve CD4 T cells toward Tregs.

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 pricing of an underwritten public offering of 3,859,650 common shares, at a public offering price of $28.50 per share (the "Offer Shares") (Press release, Merus, NOV 4, 2021, View Source [SID1234594603]). Merus also granted the underwriters a 30-day option to purchase up to an additional 578,947 common shares (the "Option Shares" and together with the Offer Shares, the "Shares"). The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses and excluding the underwriters’ option to purchase the Option Shares, are approximately $110.0 million. All of the shares in the offering are to be sold by Merus.

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The offering is expected to close on or about November 9, 2021, subject to customary closing conditions.

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 is being 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 to the prospectus describing the terms of the offering was filed with the SEC on November 4, 2021, and a final prospectus supplement will be filed with the SEC. Copies of the final 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 Company’s 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 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.