On November 7, 2019 Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, reported its financial results and operational highlights for the third quarter and nine months ended September 30, 2019 (Press release, Novavax, NOV 7, 2019, View Source [SID1234550757]).

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"The recent initiation of our pivotal NanoFlu Phase 3 clinical trial in older adults represents an important milestone toward gaining approval for our novel vaccine candidate," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Enrollment in the trial is complete and we are well positioned to deliver top-line clinical trial data in the first quarter of 2020. For ResVax, discussions with potential partners and other stakeholders are ongoing to determine the best path forward to protect vulnerable infants against RSV, for which there is currently no vaccine."

Third Quarter 2019 and Subsequent Operational Highlights

NanoFlu Program

·Novavax initiated a pivotal Phase 3 clinical trial for NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate, and completed enrollment of 2,652 healthy older adults across 19 U.S. clinical sites. The primary objective of the randomized, observer-blinded, active-controlled trial is to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains and safety compared against a licensed vaccine, Fluzone Quadrivalent.

·Top-line results from this Phase 3 clinical trial are expected in the first quarter of 2020 and would support a subsequent U.S. biologics license application (BLA) and licensure of NanoFlu using the U.S. Food and Drug Administration’s (FDA) accelerated approval pathway.

·On September 19, 2019, a Presidential Executive Order was issued that mandates the modernization of influenza vaccines for the benefit of U.S. national security and public health. This Executive Order reinforces the strategic value of the NanoFlu program in particular because, as a non-egg based vaccine formulated using recombinant nanoparticle technology and combined with a safe and potent adjuvant, NanoFlu has all the characteristics of the better influenza vaccine mandated by the Order. The full Executive Order is available here.

ResVax Program

·The FDA and the European Medicines Agency (EMA) have both recommended that Novavax conduct an additional Phase 3 clinical trial to confirm the efficacy of ResVax. Novavax is in continuing discussions with both global regulatory authorities and with potential partners to explore the opportunity to bring ResVax to market globally.

·Novavax presented additional efficacy and safety findings from the program at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual meeting in August and at the World Vaccine Congress – Europe last week. The presentations included new observations based on the recently completed analyses of the 1-year safety data, including a 56.9% (95% CI 34.5, 71.7%) reduction in the incidence of serious adverse events (SAEs) diagnosed as pneumonia, with confirmation by chest x-ray, that extended through the first year of life.

Ebola Program

·The Journal of Infectious Diseases published a peer-reviewed manuscript detailing the positive results from Novavax’ Phase 1 clinical trial in healthy adults of the Ebola virus glycoprotein vaccine candidate. Additional details of the manuscript are available here.

Corporate

·Novavax and Catalent Biologics closed the transaction under which Catalent purchased Novavax’ manufacturing equipment and related assets for approximately $18 million, assumed the property leases to two Novavax product development and manufacturing facilities and hired approximately 100 of Novavax’ manufacturing and quality employees. In addition, Catalent has begun to provide process development and manufacturing services for specified Novavax programs.

Financial Results for the Three and Nine Months Ended September 30, 2019

Share and per share data have been restated to reflect the reverse stock split that was completed in May 2019.

Novavax reported a net loss of $18.0 million, or $0.74 per share, for the third quarter of 2019, compared to a net loss of $44.6 million, or $2.33 per share, for the third quarter of 2018. For the nine months ended September 30, 2019, the net loss was $100.9 million, or $4.43 per share, compared to a net loss of $135.4 million, or $7.42 per share, for the same period in 2018. The 2019 net losses include a gain of $9.0 million recorded as a result of the Catalent transaction.

Novavax revenue in the third quarter of 2019 was $2.5 million, compared to $7.7 million in the same period in 2018. This 68% decrease was driven by the completion of enrollment of participants in the Prepare trial in the second quarter of 2018.

Research and development expenses decreased 55% to $18.6 million in the third quarter of 2019, compared to $41.3 million in the same period in 2018. This decrease was primarily due to decreased development activities of ResVax, lower employee-related costs and other cost savings due to the Catalent transaction.

General and administrative expenses slightly decreased to $7.9 million in the third quarter of 2019, compared to $8.3 million for the same period in 2018.

Interest income (expense), net for the third quarter of 2019 was ($3.1) million, compared to ($2.7) million for the same period of 2018.

As of September 30, 2019, Novavax had $75.9 million in cash, cash equivalents, marketable securities and restricted cash, compared to $103.9 million as of December 31, 2018. Net cash used in operating activities for the first nine months of 2019 was $112.9 million, compared to $139.6 million for same period in 2018.

Conference Call

Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 5956098. A replay of the conference call will be available starting at 7:30 p.m. ET on November 7, 2019 until 7:30 p.m. ET on November 14, 2019. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 5956098.

A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "Investor Info"/"Events" tab on the Novavax website. A replay of the webcast will be available on the Novavax website until February 7, 2020.

About Influenza

Influenza is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death. Serious illness occurs not only in susceptible populations such as infants, young children and older adults, but also in the general population largely because of infection by continuously evolving strains of influenza which can evade the existing protective antibodies in humans. An estimated one million deaths globally each year are attributed to influenza. Current estimates for seasonal influenza vaccine growth in the top seven markets (U.S., Japan, France, Germany, Italy, Spain and UK), show a potential increase from approximately $3.2 billion in 2015 to $5.3 billion by 2025.

About NanoFlu and Matrix-M

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes.

About Accelerated Approval

Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments. Such an approval will be based on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. For seasonal influenza vaccines, the hemagglutination inhibition (HAI) antibody response may be an acceptable surrogate marker of activity that is reasonably likely to predict clinical benefit. To be considered for accelerated approval, a biologics license application for a new seasonal influenza vaccine should include results from one or more well-controlled studies designed to meet immunogenicity endpoints and a commitment to conduct confirmatory post-marketing studies of clinical effectiveness in preventing influenza.

About RSV in Infants

Globally, RSV (respiratory syncytial virus) is the leading viral cause of severe lower respiratory tract disease in infants and young children. It is the second leading cause of death in children under one year of age. Estimated annual hospitalizations of 1.4 million and an estimated 27,300 in-hospital deaths were due to RSV acute lower respiratory infection in children under six months of age. RSV results in a total global economic burden of $6.2 billion annually.

In the U.S., RSV is the leading cause of hospitalization of infants, with estimated annual hospitalizations of up to 76,000. While RSV can impact all infants, babies under six months of age are among those at highest risk, as approximately 77% of all first-year RSV infections occur before six months. In the U.S., the total economic burden is $2.7 billion annually.

About ResVax

ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate as an adjuvant. It is being developed to protect infants from RSV disease via maternal immunization, which may offer the best method of protection from RSV disease in infants through the first months of life. ResVax is being evaluated in Prepare, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom received the vaccine, and their infants. Prepare is supported by an $89.1 million grant from the Bill & Melinda Gates Foundation (BMGF).

On November 7, 2019 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported its financial results for the quarter ended September 30, 2019 (Press release, ERYtech Pharma, NOV 7, 2019, View Source [SID1234550750]).

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"Our lead program, TRYbeCA1, the Phase 3 trial in pancreatic cancer, is progressing on plan and recently reached two important milestones," said Gil Beyen, CEO of ERYTECH. "A planned safety review by an independent data monitoring committee of the first 150 patients in the study revealed no safety concerns, and the study was opened for patient enrollment in the United States. Our new production facility in Princeton is ready to produce the batches for the U.S. patients in the trial."

Recent Business Highlights

Patient enrollment is on track in TRYbeCA1, the pivotal Phase 3 trial evaluating ERYTECH’s lead product candidate eryaspase in second-line metastatic pancreatic cancer. Clinical trial authorizations have been obtained in all twelve participating countries, eleven countries in Europe plus the United States, and the trial is actively enrolling patients in close to 50 clinical sites in Europe.

TRYbeCA1 was opened for patient enrollment in the United States last week, and the first of a total of approximately 30 planned U.S. sites were activated.

The newly established U.S. manufacturing facility in Princeton, N.J. is ready to produce clinical batches, and will supply eryaspase for the U.S. patients in the TRYbeCA1 trial.

Separately, also last week, the independent data monitoring committee (IDMC) reviewed the safety data of the first 150 patients enrolled and treated in the TRYbeCA1 trials. No safety issues were identified and the IDMC recommended to continue the trial as planned.

Q3 2019 Financial Results

Key financial figures for the first nine months of 2019 compared with the same period of the previous year are summarized below:

Net loss for the first nine months of 2019 was €43.3 million, up €13.6 million (+46%) as compared to the same period in 2018, with a €13.2 million increase (+39%) in operating loss and a €0.4 million decrease in financial income. The €13.2 million increase in operating loss was attributable to the €11.3 million increase in preclinical and clinical development expenses, mostly related to expenses incurred related to the Company’s Phase 3 clinical trial in pancreatic cancer, the €3.2 million increase in G&A expenses, of which €1.9 million related to the launch readiness of the Company’s additional manufacturing capacity, and the €1.2 million increase in operating income, of which €0.9 million upfront payment from the license agreement with SQZ Biotechnologies.

As of September 30, 2019, ERYTECH had cash and cash equivalents totaling €81.9 million (approximately $89.2 million), compared with €134.4 million on December 31, 2018 and €94.5 million at the end of June 2019. The €52.4 million decrease in cash position in the first nine months of 2019 was the result of a €55.6 million net cash utilization, comprised of a €36.7 million net cash utilization in operating activities, €19.3 million used for investing activities and €0.4 million of cash generation in financing activities, while the appreciation in the period of the U.S. dollar against the euro led to a €3.2 million favorable currency exchange impact. After a peak in capital expenditure disbursements in the first quarter of 2019 related to the expansion of the manufacturing facilities in Lyon and in Princeton, cash utilization has slowed in the second and third quarter. The Company’s cash position at the end of September remains in line with the earlier guidance of sufficient cash resources to fund operations until the end of 2020.

Key News Flow and Milestones Expected Over the Next 12 Months

First U.S. patients randomized in TRYbeCA1, the Phase 3 clinical trial in second-line metastatic pancreatic cancer (Q4 2019)

Initiation of investigator sponsored Phase 1 trial in first-line metastatic pancreatic cancer (H1 2020)

Interim results of investigator sponsored Phase 2 trial in second-line acute lymphoblastic leukemia(H1 2020)

Interim (superiority) analysis in TRYbeCA1 (Q3 2020)

Q3 2019 Conference Call Details

ERYTECH management will hold a conference call and webcast on Friday, November 8th, 2019 at 02:30pm CET / 08:30am ET on the business highlights and financial results for the third quarter of 2019. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.

The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 7394954#

USA/Canada: +1 (833) 818-6807

France: +33 1 70 80 71 53

International Dial-In Number: +1 (409) 350-3501

United-Kingdom: +44 2031070289

The webcast can be followed live online via the link: View Source

An archived replay of the call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 7394954#.

An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com

Financial Calendar

Next quarterly financial updates:

Business Update and Financial Highlights for the 4th Quarter and Full Year of 2019: March 16, 2020 (after U.S. market close), followed by a conference call and webcast on March 17, 2020 (2:30pm CET/8:30am ET)

Business Update and Financial Highlights for the 1st Quarter of 2020: May 6, 2020 (after U.S. market close), followed by a conference call and webcast on May 7, 2020 (2:30pm CET/8:30am ET)

Business Update and Financial Highlights for the 2nd Quarter of 2020: September 21, 2020 (after U.S. market close), followed by a conference call and webcast on September 22, 2020 (2:30pm CET/8:30am ET)

Business Update and Financial Highlights for the 3rd Quarter of 2020: November 5, 2020 (after U.S. market close), followed by a conference call and webcast on November 6, 2020 (2:30pm CET/8:30am ET)

ERYTECH will Present at the Following Upcoming Investor Conferences:

Jefferies Healthcare Conference, November 20-21, London

◾Salon Actionaria, November 22, Paris

ODDO Investor Conference, January 9, Lyon

LifeSci Advisors Corporate Access Event, January 13-14, San Francisco

About TRYbeCA1

TRYbeCA1 is a randomized, controlled Phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer. The trial is planned to enroll approximately 500 patients at approximately 100 clinical sites in Europe and the United States. Eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab-paclitaxel or an irinotecan-based regimen) or chemotherapy alone. The primary endpoint of TRYbeCA1 is overall survival. An interim superiority analysis will be conducted when approximately two-thirds of the events will have occurred.

On November 7, 2019 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO) reported that it has priced an underwritten public offering of 8,250,000 shares of common stock at a price to the public of $31.00 per share, before underwriting discounts, which would result in aggregate gross proceeds of approximately $256 million (Press release, Agios Pharmaceuticals, NOV 7, 2019, View Source [SID1234550724]). All of the shares in the offering are to be sold by Agios. Agios has also granted the underwriters a 30-day option to purchase up to 1,237,500 shares of common stock sold in the public offering on the same terms and conditions. Closing of the offering is expected to occur on or November 12, 2019, subject to customary closing conditions.

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J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering.

The shares are being offered by Agios pursuant to an automatically effective shelf registration statement that has been filed with the Securities and Exchange Commission ("SEC"). The offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to, and describing the terms of, the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov.

The final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, can be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 866-803-9204; Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, 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.

On November 7, 2019 AbbVie Inc. (NYSE:ABBV) ("AbbVie") reported that the requisite number of consents have been received to adopt certain proposed amendments (the "Amendments") with respect to all outstanding notes of certain series issued by Allergan Finance, LLC ("Allergan Finance"), Allergan, Inc. ("Allergan Inc"), Allergan Sales, LLC ("Allergan Sales") and Allergan Funding SCS ("Allergan Funding" and, together with Allergan Finance, Allergan Inc and Allergan Sales, "Allergan") (Press release, AbbVie, NOV 7, 2019, View Source [SID1234550723]). The results are based on (i) early tenders in the offers to exchange (each an Exchange Offer" and, collectively, the "Exchange Offers") any and all Allergan Notes (as defined below) for new notes to be issued by AbbVie (the "AbbVie Notes") and (ii) early delivery of consents in the related consent solicitations (each, a "Consent Solicitation" and, collectively, the "Consent Solicitations") being made by AbbVie on behalf of Allergan to adopt the Amendments to each of the indentures (each, an "Allergan Indenture") governing the Allergan Notes.

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The applicable Allergan obligors have executed a supplemental indenture with respect to each Allergan Indenture implementing the Amendments. The Amendments will become operative only upon settlement of the Exchange Offers. The settlement date is expected to occur promptly after the Expiration Date (as defined below), which is expected to be on or about the closing date of AbbVie’s previously announced proposed acquisition of Allergan (the "Acquisition").

As of 5:00 p.m., New York City time, on November 7, 2019 (the "Early Participation Date"), the principal amounts of Allergan Notes set forth in the table below were validly tendered and not validly withdrawn (and consents thereby validly given and not validly revoked). For each $1,000 principal amount of Allergan USD Notes (as defined below) or €1,000 principal amount of Allergan Euro Notes (as defined below) validly tendered and not validly withdrawn at or prior to the Early Participation Date, eligible holders will be eligible to receive an early participation payment of $1.00 or €1.00, as applicable, in cash (the "Early Participation Payment"). The Early Participation Payment will be paid on the settlement date for the Exchange Offers to the noteholder of record on the Early Participation Date, even if such noteholder is no longer the noteholder of record of such Allergan Notes on the settlement date. In addition, for each $1,000 principal amount of Allergan USD Notes or €1,000 principal amount of Allergan Euro Notes validly tendered and not validly withdrawn prior to the Expiration Date, eligible holders will be eligible to receive $1,000 principal amount of the AbbVie USD Notes of the applicable series or €1,000 principal amount of the AbbVie Euro Notes of the applicable series, as applicable (the "Exchange Consideration"). The total consideration consists of (a) the Exchange Consideration plus (b) the Early Participation Payment (collectively, the "Total Consideration").

After the Early Participation Date, tendered Allergan Notes may be withdrawn. However, to be eligible to receive the Exchange Consideration component of the Total Consideration, such withdrawn Allergan Notes must be validly re-tendered and not validly withdrawn at or prior to the Expiration Date. A valid withdrawal of the tendered Allergan Notes will not be deemed a revocation of the related consents and such consents will continue to be deemed delivered.

The Exchange Offers and Consent Solicitations are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement, dated October 25, 2019, and the related letter of transmittal (collectively, the "Offering Documents"), and are conditioned upon the closing of the Acquisition, which condition may not be waived by AbbVie, and certain other conditions that may be waived by AbbVie.

Each Exchange Offer will expire at 11:59 p.m., New York City time, on November 22, 2019 (as the same may be extended, the "Expiration Date"), unless terminated. Each Consent Solicitation expired at the Early Participation Date. The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and the Expiration Date of each of the Exchange Offers is expected to be extended to occur on or about the closing date of the Acquisition, which is expected to occur in early 2020. As a result, the Expiration Date may be extended one or more times. AbbVie currently anticipates providing notice of any such extension in advance of the Expiration Date.

In this news release, references to the "Allergan Euro Notes" collectively refer to (i) the Floating Rate Notes due 2020 issued by Allergan Funding, (ii) the 0.500% Senior Notes due 2021 issued by Allergan Funding, (iii) the 1.500% Senior Notes due 2023 issued by Allergan Funding, (iv) the 1.250% Senior Notes due 2024 issued by Allergan Funding, (v) the 2.625% Senior Notes due 2028 issued by Allergan Funding and (vi) the 2.125% Senior Notes due 2029 issued by Allergan Funding. References to the "Allergan USD Notes" collectively refer to (i) the 3.375% Senior Notes due 2020 issued by Allergan Inc, (ii) the 4.875% Senior Notes due 2021 issued by Allergan Sales, (iii) the 5.000% Senior Notes due 2021 issued by Allergan Sales, (iv) the 3.450% Senior Notes due 2022 issued by Allergan Funding, (v) the 3.250% Senior Notes due 2022 issued by Allergan Finance, (vi) the 2.800% Senior Notes due 2023 issued by Allergan Inc, (vii) the 3.850% Senior Notes due 2024 issued by Allergan Funding, (viii) the 3.800% Senior Notes due 2025 issued by Allergan Funding, (ix) the 4.550% Senior Notes due 2035 issued by Allergan Funding, (x) the 4.625% Senior Notes due 2042 issued by Allergan Finance, (xi) the 4.850% Senior Notes due 2044 issued by Allergan Funding and (xii) the 4.750% senior notes due 2045 issued by Allergan Funding. The Allergan USD Notes and the Allergan Euro Notes are referred to herein collectively as the "Allergan Notes."

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of Allergan Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" as defined in Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), or not a "U.S. person" and outside the United States within the meaning of Regulation S under the Securities Act. The complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the Offering Documents, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470-3900 (U.S. toll-free) or (212) 430-3774 (banks and brokers). The eligibility form is available electronically at: View Source Holders of Allergan Notes that are not eligible holders will not be able to receive such documents, but AbbVie will make alternative arrangements available, subject to applicable law. Such holders should contact Global Bondholder Services Corporation to receive information about arrangements available to them.

This news release does not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, or the solicitation of tenders or consents with respect to, any security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful. The Exchange Offers and Consent Solicitations are being made solely pursuant to the Offering Documents and only to such persons and in such jurisdictions as are permitted under applicable law.

The AbbVie Notes offered in the Exchange Offers have not been registered under the Securities Act or any state securities laws. Therefore, the AbbVie Notes may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and any applicable state securities laws.

On November 7, 2019 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases, reported financial results for the quarter ended September 30, 2019 (Press release, Aldeyra Therapeutics, NOV 7, 2019, View Source [SID1234550722]). In addition, the company updated investors on anticipated clinical milestones.

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"Aldeyra continued to make significant progress during the quarter in advancing our immunology platform toward the goal of reducing the burden of disease and helping patients lead healthier lives," said Aldeyra President and CEO Todd C. Brady, M.D., Ph.D. "We have reached agreement with the U.S. Food and Drug Administration (FDA) on the primary endpoint for our pivotal INVIGORATE Phase 3 clinical trial of reproxalap in allergic conjunctivitis. In addition, this quarter we expect to complete Part 1 of our adaptive RENEW Phase 3 clinical trial of reproxalap in dry eye disease, and initiate the first part of our adaptive GUARD Phase 3 clinical trial in proliferative vitreoretinopathy, representing the expansion of our ocular program from the front of the eye to the retina."

Clinical Milestone Updates

Dry Eye Disease: Part 1 of Adaptive RENEW Phase 3 Clinical Trial Scheduled for Completion in the Fourth Quarter of 2019. Part 1 of the two-part adaptive RENEW Phase 3 dry eye disease clinical trial of topical ocular reproxalap, the company’s lead reactive aldehyde species (RASP) inhibitor, is scheduled for completion in the fourth quarter of 2019, at which point Aldeyra plans to announce the endpoints, dosing regimen, and sample size planned for Part 2 of the trial. Dry eye disease affects more than 34 million adults in the U.S., and physicians and patients generally regard current therapeutic options as inadequate.

Allergic Conjunctivitis: INVIGORATE Phase 3 Clinical Trial Scheduled to Initiate in the First Half of 2020. Aldeyra recently released expanded data from the completed allergen chamber clinical methods trial of topical ocular reproxalap and announced the design of the INVIGORATE Phase 3 clinical trial, which is expected to initiate in the first half of 2020. The primary endpoint of INVIGORATE is statistical significance versus vehicle in ocular itch (0-4 scale) at a majority of 11 time points between 110 and 210 minutes after chamber entry. In October, the company presented the results of the ALLEVIATE Phase 3 clinical trial in allergic conjunctivitis at the American Academy of Ophthalmology Annual Meeting in San Francisco. ALLEVIATE met the primary endpoint of reduction of ocular itch versus vehicle following conjunctival allergen challenge. Of the estimated 100 million allergic conjunctivitis sufferers in the U.S., up to 30 million do not respond adequately to, or are dissatisfied with, antihistamines.

Proliferative Vitreoretinopathy: Part 1 of the Adaptive GUARD Phase 3 Clinical Trial Scheduled to Initiate in the Fourth Quarter of 2019. Patient enrollment in Part 1 of the adaptive GUARD Phase 3 Clinical Trial of ADX-2191 is expected to begin in the fourth quarter of 2019. GUARD will compare recurrence rates across patients treated with ADX-2191 or standard of care following surgical repair of retinal detachment due to proliferative vitreoretinopathy (PVR). In September, the FDA granted fast track designation to ADX-2191 for the prevention of PVR, a rare inflammatory disorder of the retina that leads to severe retinal scarring and blindness. There is no approved therapy for PVR. More than 50% of PVR cases result in severe uncorrectable vision loss, and 76% of patients suffer from at least moderate uncorrectable vision loss.

Systemic Autoimmune Disease: ADX-629 Phase 1 Clinical Trial Initiated. Patient enrollment is underway in the Phase 1 clinical trial of ADX-629, a novel orally administered RASP inhibitor in development for the treatment of systemic autoimmune disease and potentially other serious medical conditions.

Post-transplant Lymphoproliferative Syndrome: Phase 2 Clinical Trial of ADX-1612 Scheduled to Initiate in the Fourth Quarter of 2019. The Phase 2 clinical trial of ADX-1612, Aldeyra’s lead chaperome inhibitor, is slated to start in the fourth quarter of 2019 in patients with post-transplant lymphoproliferative syndrome, a rare and potentially fatal immunological disease that can occur following solid organ transplant.

Outlook

"We expect our clinical momentum to accelerate as we move through the fourth quarter of this year and into 2020," Dr. Brady said. "We believe that reproxalap has the potential to be the next novel entrant in dry eye disease and allergic conjunctivitis, part of a spectrum of conditions estimated to affect more than four in ten Americans. Our ocular programs represent the initial step of our mission to develop therapies for a broad category of systemic immune-mediated diseases."

Quarter Ended September 30, 2019 Financial Review

For the quarter ended September 30, 2019, Aldeyra reported a net loss of approximately $18.7 million, compared with a net loss of approximately $10.8 million for the quarter ended September 30, 2018. Basic and diluted net loss per share was $0.69 for the quarter ended September 30, 2019, compared with $0.52 per share for the same period in 2018. Losses resulted from the costs of research and development programs, as well as from general and administrative expenses.

Research and development expenses were $16.2 million for the quarter ended September 30, 2019, compared with $7.9 million for the same period in 2018. The increase of $8.3 million is primarily related to an increase in clinical and preclinical development and manufacturing costs; an increase in personnel costs; and non-cash compensation costs related to a portion of upfront acquisition consideration that is subject to vesting based on continued service.

General and administrative expenses were $2.8 million for the quarter ended September 30, 2019, compared with $3.1 million for the quarter ended September 30, 2018. The decrease of $0.3 million is primarily related to lower consulting costs.

For the quarter ended September 30, 2019, total operating expenses were approximately $19.0 million, compared with total operating expenses of approximately $10.9 million for the same period in 2018.

As of September 30, 2019, cash, cash equivalents, and marketable securities were $76.2 million, which includes $15.0 million drawn from the company’s debt facility in September 2019.

Conference Call & Webcast Information

Aldeyra will host a conference call today at 8:00 a.m. ET to discuss its third-quarter financial results and provide a corporate update. The dial-in numbers are 1-866-211-4098 for domestic callers and 1-647-689-6613 for international callers. The conference ID number for the live call will be 9487086.

A live webcast of the conference call will also be available on the Investors Relations section of the Aldeyra Therapeutics website at View Source After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for one year.