On May 2, 2019 Evelo Biosciences, Inc. (Nasdaq: EVLO) ("Evelo"), a clinical stage biotechnology company developing oral biologics that act on cells in the small intestine with striking therapeutic effects throughout the body, reported financial results and provided a business update for the first quarter of 2019 (Press release, Evelo Biosciences, MAY 2, 2019, View Source [SID1234535675]).

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"We continue to progress therapies targeting cells in the small intestine to drive systemic effects to treat major diseases. We look forward to clinical data from our first inflammatory disease trial of EDP1066 in healthy volunteers and psoriasis patients early in the third quarter and in atopic dermatitis patients shortly thereafter," said Simba Gill, Ph.D., chief executive officer of Evelo. "In addition, we have discovered novel formulations of monoclonal microbials which significantly improve potency in preclinical models. In parallel with completion of the current patient cohorts, we are advancing a novel formulation into our ongoing clinical studies, providing us with the opportunity for additional clinical readouts in the near term."

Business Highlights:

Platform Discovery: Novel Formulations with Increased Potency

Evelo has discovered a new formulation that enhances the pharmacological potency of monoclonal microbials by up to 30-fold in preclinical in vivo models.

This proprietary formulation enhances the probability of translating preclinical effects into patients and can be commercialized cost effectively.

Evelo plans to introduce this formulation into ongoing and new clinical trials beginning in the second half of 2019 across multiple monoclonal microbials.

Evelo continues to invest in enhanced forms and formulations of oral biologics.

Ongoing Clinical Studies and Anticipated Milestones

Inflammation:

EDP1066 – Phase 1b

Healthy volunteers and psoriasis patients – Evelo expects to complete dosing this quarter and to report initial clinical data early in the third quarter of 2019.

Atopic dermatitis patients – Following the recent addition of a new cohort of patients, Evelo expects to report initial clinical data in the third quarter of 2019.

New formulation – Evelo expects to report initial clinical data from cohorts of psoriasis and atopic dermatitis patients during the fourth quarter of 2019 and the first quarter of 2020, respectively.

EDP1815 – Phase 1b

Evelo completed dosing of EDP1815 in two dose-ascending healthy volunteer cohorts. Based on the data reviewed by the trial’s safety committee, the trial proceeded as planned into patients.

Following the addition of a new formulation into the trial, Evelo expects to report initial clinical data from psoriasis and atopic dermatitis patients in early 2020.

Anticipated Additional Studies

Evelo expects to continue to conduct immuno-pharmacology studies in healthy volunteers with EDP1066 and EDP1815 to explore additional doses and formulations.

Subject to data from ongoing trials, Evelo expects to initiate clinical trials in additional inflammatory disease indications in the second half of 2019.

Oncology:

EDP1503 – Phase 1/2

Evelo is conducting a Phase 1/2 clinical trial of EDP1503 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in microsatellite stable colorectal cancer, triple-negative breast cancer, and patients with other tumor types that have relapsed on prior PD-1/L1 inhibitor treatment. Initial clinical data is expected in the first half of 2020.

EDP1503 – Phase 2a

The University of Chicago is conducting a Phase 2a investigator-sponsored clinical trial of EDP1503 in combination with KEYTRUDA in naive melanoma patients and melanoma patients who have relapsed on prior PD-1/L1 inhibitor treatment. Initial clinical data expected in second half of 2020.

First Quarter 2019 Financial Results

Cash Position: As of March 31, 2019, cash, cash equivalents and investments were $129.4 million, as compared to cash and cash equivalents of $147.9 million as of December 31, 2018. This decrease was due to cash used to fund operating activities and capital expenditures for the first quarter of 2019. Evelo expects that its cash, cash equivalents and investments will enable it to fund its planned operating expenses and capital expenditure requirements into the second half of 2020.

Research and Development Expenses: R&D expenses were $15.7 million for the three months ended March 31, 2019, compared to $7.1 million for the three months ended March 31, 2018. The increase of $8.6 million was due primarily to increases in costs related to Evelo’s inflammation and oncology clinical development programs, and research platform expenses, as well as increased personnel costs.

General and Administrative Expenses: G&A expenses were $5.1 million for the three months ended March 31, 2019, compared to $3.3 million for the three months ended March 31, 2018. The increase of $1.8 million was due primarily to increased general and administrative personnel costs, professional and consulting fees, and facility expenses supporting Evelo’s growing R&D organization and public company infrastructure.

Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $20.3 million for the three months ended March 31, 2019, or $(0.64) per basic and diluted share, as compared to a net loss attributable to common stockholders of $12.9 million for the three months ended March 31, 2018, or $(3.29) per basic and diluted share.

Conference Call
Evelo will host a conference call and webcast today at 8:30a.m. ET. To access the call please dial (866) 795-3242 (domestic) and (409) 937-8909 (international) and provide the passcode 1838168. A live webcast of the call will be available on the Investors sections of the Evelo website at www.evelobio.com. The archived webcast will be available approximately two hours after the conference call and will be available for 30 days following the call.

On May 2, 2019 Novavax, Inc., (Nasdaq: NVAX) reported its financial results and operational highlights for the first quarter ended March 31, 2019 (Press release, Novavax, MAY 2, 2019, View Source [SID1234535701]).

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First Quarter 2019 and Subsequent Operational Highlights

ResVax Program

In February 2019, Novavax announced top-line data from the Prepare trial, which was designed to determine the efficacy of ResVax against medically significant respiratory syncytial virus (RSV)-positive lower respiratory tract infection (LRTI) in infants. ResVax is the first RSV vaccine to demonstrate efficacy in infants.

In April 2019, Novavax presented additional results at the World Vaccine Congress in Washington, D.C. from the Prepare trial of ResVax. Although the Prepare trial results did not meet the pre-specified primary efficacy endpoint, it demonstrated efficacy against RSV LRTI hospitalizations, a pre-specified secondary endpoint. RSV LRTI hospitalization is not only an important indication of the severity of RSV disease in infants, it also reflects a significant economic burden to global health systems.
NanoFlu Program

In January 2019, Novavax announced positive top-line results of its Phase 2 clinical trial of NanoFlu comparing various quadrivalent formulations, with or without Novavax’ Matrix-M adjuvant, with two U.S.-licensed influenza vaccines in older adults. These results show that NanoFlu with Matrix-M generated enhanced immune responses compared to the unadjuvanted formulation, and importantly, showed superior hemagglutination inhibition antibody (HAI) responses against wild-type A(H3N2) viruses, including drifted strains, when compared to Fluzone High-Dose, the leading flu vaccine in older adults.
Key Upcoming Events

Meet with the FDA, European regulatory agencies, and potentially other national regulatory agencies during the second and third quarters, to assess opportunities for submission of marketing applications for ResVax.
Reach agreement with the FDA during the third quarter of 2019 on a proposed Phase 3 clinical trial design for NanoFlu utilizing accelerated approval criteria for licensure.
Present ResVax Phase 3 clinical trial data at the 37th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID) on May 7, 2019.
Financial Results for the First Quarter Ended March 31, 2019

Novavax reported a net loss of $43.2 million, or $0.11 per share, for the first quarter of 2019, compared to a net loss of $46.4 million, or $0.14 per share, for the first quarter of 2018.

Novavax revenue in the first quarter of 2019 was $4.0 million, compared to $9.7 million in the same period in 2018. This 59% decrease was driven by the completion of enrollment of the Prepare trial in the second quarter of 2018.

Research and development expenses decreased 20% to $35.5 million in the first quarter of 2019, compared to $44.5 million for the same period in 2018. This decrease was primarily due to decreased development activities, including lower clinical trial costs, of ResVax.

General and administrative expenses were flat at $8.7 million in the first quarter of 2019, compared to the same period of 2018.

Interest income (expense), net was ($3.0) million in the first quarter of 2019, compared to ($2.9) million for the same period of 2018.

As of March 31, 2019, Novavax had $108.7 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 quarter of 2019 was $50.6 million, compared to $66.1 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 5394082. A replay of the conference call will be available starting at 7:30 p.m. ET on May 2, 2019 until 7:30 p.m. ET on May 9, 2019. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 5394082.

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 August 2, 2019.

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. Estimated annual hospitalizations are 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. In February 2019, Novavax announced top-line data from Prepare, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom have received the vaccine, and their infants. Prepare is supported by an $89.1 million grant from the Bill & Melinda Gates Foundation (BMGF).

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 2012-13 season to $5.3 billion by the 2021-22 season.

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 protein amino acid sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which is potent and well- stimulates both high quality and durable antibody responses as well as multifunctional CD4 and CD8 T-cell responses. In January 2019, Novavax announced positive top-line data from its Phase 2 clinical trial in older adults of quadrivalent formulations of NanoFlu in 1,375 healthy older adults across clinical sites in the U.S.

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.

On May 2, 2019 Medigene AG (FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported that Dr. Maja Buerdek, Director Cellular Tools, gave an oral presentation on in vitro assays to evaluate potential TCR-mediated toxicity against neuronal cells at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting in Washington, DC (Press release, MediGene, MAY 2, 2019, View Source [SID1234535565]).

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Before TCR-transgenic T cells (TCR-Ts) enter clinical studies for adoptive immunotherapy of cancer, they need to be systematically tested for possible toxic effects against healthy tissues. Toxicity can be due either to on-target/off-tumor or off-target recognition by TCR-Ts.

Medigene has developed physiologically relevant 2-dimensional and 3-dimensional in vitro models to assess potential TCR-T-mediated toxicities against a variety of healthy tissues, whereby neuronal toxicity represents a special case due to paucity of non-malignant cell lines and fresh brain tissue samples. Therefore, assessments for neurotoxicity were made using inhibitory GABA neurons and astrocytes derived from induced pluripotent stem cells (iPSCs). Neither neuronal cell type was found to express PRAME antigen as determined by direct qPCR studies in vitro. Furthermore, extensive in silico data of PRAME RNA and protein expression as well as in vitro studies of RNA in a specialized panel of 24 brain tissues failed to detect PRAME expression. Thereby, these cell types theoretically should not represent direct targets for PRAME-specific TCR-Ts through on-target/off-tumor recognition since they lack specific endogenous PRAME expression. Nevertheless, neuronal cells could potentially still be recognized via PRAME-specific TCR-Ts due to off-target toxicity, based on TCR cross-reactivity for an undefined target.

Importantly, cell surface expression of HLA-A2 on neurons, a precondition for recognition by HLA-A2-restricted PRAME-specific TCR-Ts, could only be measured after treatment with interferon gamma, mimicking a pro-inflammatory environment. Therefore, to demonstrate general susceptibility to recognition and killing via TCR-Ts, and to directly assess both on target/off-tumor and off-target toxicity, the neuronal cells were pre-treated with interferon gamma and loaded exogenously with PRAME peptide and then tested with PRAME-specific TCR-Ts. The neuronal cells were recognized and killed, demonstrating that specific recognition could be detected in this 2D assay system. Importantly, non-peptide-loaded neuronal cells survived in the presence of PRAME-specific TCR-Ts in 2D co-cultures assaying for specific cytokine release and killing. Thus, both cell types were not found to be susceptible to on-target/off-tumor toxicity, as predicted, nor were they susceptible to off-target toxicity.

Since neuronal cells could show different characteristics in vivo based on tissue-like structures, 3D neuro-spheroids were generated and utilized in co-culture assays with PRAME-specific TCR-Ts. The results confirmed those described for the 2D system, whereby 3D neuro-spheroids were not killed by the PRAME-specific TCR-Ts, whereas exogenous loading of 3D neuro-spheroids with PRAME peptide led to an efficient killing of the neurons by the PRAME-specific TCR-Ts.

Dr Maja Buerdek, Director Cellular Tools at Medigene, commented: "Medigene has added these new functional in vitro assays for evaluation of TCR-T toxicity against neuronal cells to enlarge our extensive preclinical toolbox that allows for systematic assessment of TCR-T specificity, safety and pre-clinical efficacy in vitro. The PRAME-specific TCR-Ts analyzed in these studies showed a favorable safety pattern against both iPSC-derived astrocytes and GABA neurons in vitro using 2D and 3D co-culture models."

On May 2, 2019 Seres Therapeutics, Inc. (Nasdaq: MCRB) ("Seres" or the "Company") reported first quarter 2019 financial results and provided business updates (Press release, Seres Therapeutics, MAY 2, 2019, View Source [SID1234535581]).

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"In recent months, Seres has made significant corporate and clinical progress to concentrate our resources on our highest priority therapeutic candidates with the goal of rapidly achieving key pipeline milestones. This has included the appointment of new leadership, pipeline focusing and prioritization, streamlining of costs, initiation of two clinical studies and the initiation of an oncology-focused collaboration with AstraZeneca," said Eric D. Shaff, President and Chief Executive Officer at Seres. "As part of this strategy, we are announcing today the modification of our ongoing SER-109 Phase 3 ECOSPOR III study in patients with recurrent C. difficile infection. We believe this modification meaningfully accelerates the expected timing for top-line data readout while maintaining a high level of scientific and statistical rigor. We remain enthusiastic about the potential for SER-109, which is supported by compelling clinical and mechanistic evidence."

"With our corporate strategy clearly defined, we look forward to a data-rich 2020 with four significant milestones expected: SER-287 Phase 2b readout in mild-to-moderate ulcerative colitis; SER-109 Phase 3 readout in recurrent C. difficile infection; SER-401 Phase 1b readout in metastatic melanoma; and advancing our rationally-designed, fermented SER-301 preclinical program to clinical development for ulcerative colitis. We are also excited to expand the development of new microbiome-based therapeutic approaches for cancer through our recent collaboration with AstraZeneca," concluded Mr. Shaff.

Program Updates and Corporate Highlights

SER-287 Phase 2b ECO-RESET study in ulcerative colitis: SER-287 is an oral, donor-derived microbiome therapeutic candidate designed to normalize the gastrointestinal microbiome of individuals with ulcerative colitis. In April 2019, Seres obtained U.S. Food & Drug Administration ("FDA") Fast Track designation for SER-287 for the induction and maintenance of clinical remission of adult subjects with active mild-to-moderate ulcerative colitis. Seres continues to enroll the SER-287 Phase 2b ECO-RESET induction study in patients with active mild-to-moderate ulcerative colitis. The development of SER-287 is supported by a successful Phase 1b study conducted in 58 patients with active mild-to-moderate ulcerative colitis that demonstrated a beneficial impact on clinical remission and endoscopic improvement, various markers of SER-287 biological activity, including SER-287 microbiome engraftment, as well as detection of metabolomic markers and biopsy transcriptional signals correlating with the clinical results. Preliminary data from the study also showed that those patients who achieved clinical remission did not experience a disease flare in the 26-week period following study initiation. In the SER-287 Phase 1b study, the safety profile for SER-287 was comparable with that of placebo with no imbalance of adverse events and no drug-related serious adverse events.

The SER-287 Phase 2b ECO-RESET study was initiated in December 2018 and is expected to enroll approximately 201 patients with mild-to-moderate ulcerative colitis. Based on FDA feedback, Seres expects that with positive Phase 2b study results, the study could serve as one of two pivotal trials to enable a SER-287 Biologics License Application (BLA) submission.

Seres expects to complete enrollment of the SER-287 Phase 2b ECO-RESET study by mid-2020 and report top-line data in the third quarter of 2020.
SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109 is an oral, donor-derived microbiome therapeutic candidate designed to restore the depleted, or dysbiotic, gastrointestinal microbiome of patients with recurrent C. difficile infection. Seres has been enrolling a 320 patient, placebo-controlled SER-109 Phase 3 study, ECOSPOR III, in patients with recurrent C. difficile infection. All patients enrolled in ECOSPOR III were required to test positive for C. difficile cytotoxin to ensure enrollment of only patients with an active C. difficile infection.

The original 320 patient ECOSPOR III trial was designed to evaluate SER-109 efficacy, a comprehensive safety database, and to serve as a single pivotal study supporting BLA submission. Consistent with the Company’s strategy to obtain rigorous, near-term clinical data, the Company has implemented a revised ECOSPOR III study design that reduces the size of the study to 188 patients. The new size and powering calculations are informed by prior SER-109 study results, published C. difficile infection trial data utilizing cytotoxin testing and preliminary blinded and open label C. difficile infection recurrence rate data from the ongoing ECOSPOR III study. Seres has informed the FDA regarding the ECOSPOR III study modification and plans to further discuss options to expedite the SER-109 development path toward potential BLA submission.

In prior communications with the FDA regarding a potential reduction in ECOSPOR III study size, the agency indicated that if the statistical significance of the outcome of the study is insufficient to support BLA submission, the Company could be required to obtain additional confirmatory evidence of efficacy, such as a second Phase 3 study. Reducing the study size would likely require additional patient exposure to further establish safety. The Company believes that this study revision is designed to provide rigorous efficacy data. Furthermore, based on the safety results observed in all of its microbiome therapeutics clinical trials to date, the Company expects to be able to work with FDA to satisfy additional safety data requirements, if needed.

As of April 30, 2019, ECOSPOR III had enrolled 135 patients. Seres expects to complete enrollment of SER-109 ECOSPOR III by the end of 2019 and report top-line data in early 2020.
SER-401 Phase 1b in metastatic melanoma: SER-401 is an oral microbiome therapeutic candidate comprising a bacterial signature similar to that observed in checkpoint inhibitor immunotherapy responders. The ongoing Phase 1b study, supported by The University of Texas MD Anderson Cancer Center and the Parker Institute for Cancer Immunotherapy, will evaluate the potential for SER-401 to augment response to nivolumab, an approved anti-PD-1 checkpoint inhibitor therapy, and will assess a variety of biological measures of response.

Seres expects to obtain SER-401 Phase 1b preliminary study results in 2020.
SER-301 preclinical candidate: Seres also continues to advance its rationally-designed, fermented microbiome drug discovery and development capabilities. These efforts are focused on advancing SER-301, a preclinical therapeutic candidate for ulcerative colitis, into clinical development. The Company is entitled to a $10 million milestone payment associated with the initiation of SER-301 clinical development from its ongoing collaboration with Nestlé Health Science.

Seres expects to file an Investigational New Drug (IND) application and initiate clinical development for SER-301 in early 2020.
Microbiome immuno-oncology focused collaboration with AstraZeneca: In March 2019, Seres announced a collaboration with MedImmune LLC, a wholly owned subsidiary of AstraZeneca Inc. ("AstraZeneca") to focus on advancing the mechanistic understanding of the microbiome in augmenting the efficacy of cancer immunotherapy, including potential combination with SER-401. Under the terms of the collaboration, AstraZeneca has agreed to provide Seres with $20 million in three equal installments. In addition, AstraZeneca has agreed to reimburse Seres for research activity related to the collaboration. Seres maintains rights to oncology-targeted microbiome therapeutic candidates, and AstraZeneca has obtained the exclusive option to negotiate for exclusive rights to those programs and other inventions arising out of the collaboration.
Implemented key leadership changes: In January 2019, Seres announced the appointment of Eric D. Shaff as President and Chief Executive Officer. Mr. Shaff, who was Chief Operating and Financial Officer, succeeded Roger J. Pomerantz, M.D., who continues as Chair of Seres’ Board of Directors. Matthew Henn, Ph.D., previously Executive Vice President and Head of Discovery and Microbiome R&D, was appointed Chief Scientific Officer. In February 2019, Seres took action to lower corporate expenses and reduced its full-time workforce by approximately 30%.
Financial Results
Seres reported a net loss of $24.3 million for the first quarter of 2019, as compared to a net loss of $27.9 million for the same period in 2018. The first quarter net loss was driven primarily by clinical and development expenses, personnel expenses and ongoing development of the Company’s microbiome therapeutics platform. The first quarter net loss figure was inclusive of $7.3 million in recognized revenue associated primarily with the Company’s collaboration with Nestlé Health Science.

Research and development expenses for the first quarter of 2019 were $22.9 million, as compared to $23.5 million for the same period in 2018. The research and development expense was primarily related to Seres’ microbiome therapeutics platform, the clinical development of SER-109 and SER-287, as well as the Company’s immuno-oncology efforts.

General and administrative expenses for the first quarter of 2019 were $7.5 million, as compared to $8.8 million for the same period in 2018. General and administrative expenses were primarily due to headcount, professional fees and facility costs.

During the first quarter of 2019 Seres recognized $1.5 million in restructuring expenses related to the corporate changes discussed earlier.

Seres ended the first quarter with approximately $53.6 million in cash and cash equivalents compared with $85.8 million at December 31, 2018. In April 2019 and following the close of the first quarter of 2019, the Company received the first of three $6.7 million annual installment payments due under the terms of the collaboration with AstraZeneca.

Based on the Company’s current operating plan, cash resources are expected to fund operating expenses and capital expenditure requirements, excluding net cash flows from future business development activities or potential incoming milestone payments, into the fourth quarter of 2019.

Conference Call Information
Seres’ management will host a conference call today, May 2, 2019, at 8:30 a.m. ET. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 3368968. To join the live webcast, please visit the "Investors and Media" section of the Seres website at www.serestherapeutics.com.

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.

On May 2, 2019 Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported its financial results for the first quarter ended March 31, 2019 (Press release, Alder Biopharmaceuticals, MAY 2, 2019, View Source [SID1234535702]).

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"The recent acceptance by the U.S. Food and Drug Administration (FDA) of our Biologics License Application (BLA) for eptinezumab was another major milestone for Alder and moves us one step closer to making the first quarterly infusion prevention therapy available to the millions of patients debilitated by episodic and chronic migraine," said Bob Azelby, Alder’s president and chief executive officer. "We are in a strong position as we continue to prepare to commercialize eptinezumab in the first quarter of 2020, by building commercial inventory and expanding our commercial infrastructure. Additionally, in pursuit of Alder’s mission to forever change migraine treatment, we are excited to announce today that we plan to initiate a Phase 3 clinical trial of eptinezumab for the acute treatment of migraine in the second half of 2019."

First Quarter 2019 Highlights

On April 22, 2019, Alder announced its BLA submission for eptinezumab, the company’s investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide (CGRP) and lead commercial candidate, was accepted by the FDA. The FDA has set the Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2020. The BLA includes, and is supported by, positive data from Alder’s PROMISE 1 and PROMISE 2 Phase 3 clinical trials, open-label safety study, pharmacokinetic (PK) comparability study and chemistry, manufacturing, and controls (CMC) data packages.
In April, Alder announced the appointment of Nadia Dac as chief commercial officer. Ms. Dac brings more than two decades of U.S. and global commercial experience in neurology with both large and small publicly traded biopharmaceutical companies, with extensive expertise across all commercial functions including marketing, market access and promotion, sales, pipeline management, business development and partnerships. She joins Alder from AbbVie, where she served as vice president of global specialty commercial development.
In March, Alder closed an underwritten public offering and concurrent private placement in which the company received net proceeds of $159.3 million (which included the exercise of an over-allotment option granted to the underwriters in the public offering).
In January, Alder announced the appointment of Dr. Paul Streck, M.D. as chief medical officer. He brings more than 25 years of experience in drug development, regulatory and medical affairs leadership across both large and small publicly traded biopharmaceutical companies. Dr. Streck previously served as chief medical officer at Insmed Incorporated, where he played an instrumental role as a member of the executive leadership team and successfully led the Arikayce regulatory filing, approval and launch.
In January, an amendment to Alder’s contract manufacturing agreement with Sandoz GmbH for the production of eptinezumab became effective. Pursuant to this amendment, Sandoz will manufacture and supply guaranteed quantities of eptinezumab drug substance for a five year term, running through 2023. Alder anticipates the guaranteed quantities will be sufficient to supply U.S. and ex-U.S. markets beyond 2023, if eptinezumab is approved.
Upcoming Anticipated Milestones

Alder plans to initiate a Phase 3 clinical trial evaluating eptinezumab as a treatment for acute migraine in the second half of 2019. The trial will seek to leverage eptinezumab’s 100% bioavailability and rapid onset of prevention demonstrated in clinical testing, with the objective of securing an indication for the acute treatment of migraine and positioning eptinezumab as the only anti-CGRP monoclonal antibody for the treatment and prevention of migraine, if approved for these indications.
Alder remains on track for the potential commercial launch of eptinezumab in the first quarter of 2020, and continues to advance its manufacturing and commercial readiness activities in anticipation of launch. Currently, Alder is advancing its supply chain, building commercial inventory, continuing to build out its commercial and operational infrastructure, and executing against other key pre-launch initiatives.
Alder continues to advance its pre-clinical candidate, ALD1910, a monoclonal antibody targeting PACAP-38 (pituitary adenylate cyclase-activating peptide-38). ALD1910 is currently undergoing Investigational New Drug (IND)-enabling preclinical studies and Alder expects to initiate a first in-human clinical study by the end of 2019.
First Quarter 2019 Financial Results

As of March 31, 2019, Alder had $498.5 million in cash, cash equivalents, investments and restricted cash, compared to $412.4 million as of December 31, 2018.
Research and development expenses for the first quarter ended March 31, 2019 totaled $69.6 million, compared to $74.0 million for the same period in 2018. The year-over-year decrease was primarily due to lower clinical trial costs, partially offset by expenses related to securing manufacturing capacity and the initial build of commercial inventory in preparation for the launch of eptinezumab.
General and administrative expenses for the first quarter ended March 31, 2019 totaled $44.5 million, compared to $11.6 million for the same period in 2018. The year-over-year increase reflects a $26 million loss contingency provision relating to a dispute over a contract we terminated for breach by the other party, as well as Alder’s continued ramp-up of the commercial organization and infrastructure required for the anticipated commercialization of eptinezumab.
Net loss applicable to common stockholders for the first quarter ended March 31, 2019 totaled $119.2 million, or $1.63 per share, compared to net loss of $117.6 million, or $1.73 per share on a fully-diluted basis, for the same period in 2018.
Financial Outlook

Alder continues to expect that full-year 2019 net cash used in operating activities and purchases of property and equipment will be in the range of $285 to $315 million. The majority of the spend is focused on ensuring that Alder is prepared for the potential launch of eptinezumab in the first quarter of 2020, including advancing eptinezumab’s supply chain, building commercial inventory, continuing to build out Alder’s commercial footprint and other pre-launch market readiness activities.

Alder believes its available cash, cash equivalents, investments and restricted cash will be sufficient to meet its projected operating requirements through the anticipated launch of eptinezumab and into the latter part of 2020.

Conference Call and Webcast
Alder will host a conference call today at 5:00 p.m. ET to discuss these financial results and recent corporate highlights. The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers, and providing conference ID number 8162289. The webcast will be broadcast live and can be accessed from the Events & Presentations page in the Investors section of Alder’s website at www.alderbio.com. The accompanying slides are available now at the Events & Presentations page in the Investors section of Alder’s website at www.alderbio.com. The webcast will be available for replay following the call for at least 30 days.