On May 8, 2019 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported financial results for the three months ended March 31, 2019 and provided a corporate update (Press release, Portola Pharmaceuticals, MAY 8, 2019, View Source [SID1234535924]).

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"Our first quarter results continue to reflect strong demand for Andexxa, as well as focused execution on our commercial launch. The full commercial U.S. launch of Andexxa is off to a great start, and with approval of Ondexxya in Europe, we now have another long-term growth catalyst and the ability to impact thousands of additional patient lives," said Scott Garland, Portola’s president and chief executive officer. "Additionally, we continue to make progress with cerdulatinib and look forward to further defining the safety and efficacy profile, along with that of Andexxa, in a number of scientific presentations anticipated in Q2."

Quarter Ending March 31, 2019

Total revenues for the first quarter of 2019 were $22.2 million, compared with $6.6 million for the first quarter of 2018. This includes $20.3 million in net product revenues from Andexxa sales, $77 thousand in revenues from Bevyxxa sales and $1.8 million in collaboration and license revenues. Please see the tables at the end of this press release for a detailed breakdown of revenues.

Net loss attributable to Portola, according to generally accepted accounting principles in the U.S. (GAAP), was $78.2 million for the first quarter of 2019, or $1.17 net loss per share, compared with a net loss of $84.2 million, or $1.28 net loss per share, for the same period in 2018. This includes the effect of two charges taken in the first quarter related to the FDA approval for the Company’s Gen 2 manufacturing process. The first is a $5.8 million charge associated with the valuation of the Company equity that will be issued to Lonza, our Andexxa Gen 2 manufacturer ("manufacturing site charge"), and the second is a $3.9 million charge associated with the Andexxa Gen 1 product as hospitals transition to the Gen 2 product ("Gen 1 supply charge").

Non-GAAP net loss for the first quarter of 2019 was $68.4 million, or a non-GAAP basic and diluted loss per share of $1.02. Non-GAAP net loss and net loss per share have been adjusted to remove the manufacturing site charge and the Gen 1 supply charge. Please see the reconciliation of GAAP to non-GAAP financial measures at the end of this release for more details.

Cash, cash equivalents and investments at March 31, 2019 totaled $322.8 million, compared with $317.0 million as of December 31, 2018. In March, the Company entered into a $125 million loan agreement and received an initial tranche of $62.5 million, with the balance available at Portola’s option in the third quarter, subject to certain conditions, extending our cash runway to the end of 2020.

Total operating expenses for the first quarter of 2019 were $95.8 million, compared with $91.9 million for the same period in 2018. The increase was driven by the timing of launch activities in the U.S., the build-out of the Company’s field force and launch preparations in Europe.

Non-GAAP total operating expenses, which excludes the two charges outlined above, were $86.0 million for the first quarter of 2019. Please see the reconciliation of GAAP to non-GAAP financial measures table at the end of this release for more details.

Stock-based compensation expense for the first quarter of 2019 was $17.9 million, compared with $11.0 million for the same period in 2018. This year-over-year increase was driven primarily by the equity issued for the manufacturing site charge.

Cost of Sales (COS) for the first quarter of 2019 were $7.2 million, compared to $336 thousand for the same period in 2018. The increase was driven by the launch of Andexxa and the Gen 1 supply charge.

Research and development (R&D) expenses were $35.6 million for the first quarter of 2019, compared with $60.1 million for the first quarter of 2018. The decrease was driven primarily by the manufacturing costs for Andexxa Gen 2 being capitalized and no longer flowing through R&D.

Selling, general and administrative (SG&A) expenses for the first quarter of 2019 were $53.0 million, compared with $31.5 million for the same period in 2018. The increase was driven by the expansion of the Company’s field force, commercial activities to support the launch of Andexxa and launch preparations in Europe.

Recent Achievements and Events

Received European Commission approval of Ondexxya and hired Head of Europe to build a team to support planned commercial activity.

Received C-code from The Centers for Medicare & Medicaid Services, allowing hospitals an additional reimbursement pathway for Andexxa.

Submitted additional data to the U.S. Food and Drug Administration on the proposed dose for cerdulatinib.

Announced the retirements of Portola co-founder Charles Homcy, M.D. from the Board of Directors, and John Curnutte, M.D., Ph.D., Executive Vice President of Research and Development.

Upcoming Milestones

Staged launch of Ondexxya in a select group of high-potential European countries where Factor Xa use is among the highest.

Present new data on:

The impact of Andexxa on patients with an intracranial hemorrhage at the European Stroke Organization Conference in Milan in May.

The question of whether PCCs have clinical activity in the reversal of direct FXa inhibitors at the International Society of Thrombosis and Hematology meeting in Melbourne.

The safety and efficacy of cerdulatinib in relapsed/refractory follicular lymphoma, either alone or in combination with rituximab.

Initiate discussions with the FDA on a number of potential label expansion opportunities including the addition of the ANNEXA-4 efficacy data, the inclusion of edoxaban and enoxaparin, and the potential initiation of a study in urgent surgery.

Conference Call Details

Portola will host a conference call today, Wednesday, May 8, 2019, at 8:30 a.m. ET, during which time management will discuss the first quarter 2019 financial results, updates on the U.S. launch of Andexxa, launch preparations in Europe and other matters. The live call can be accessed by phone by dialing (844) 452-6828 from the U.S. and Canada or 1 (765) 507-2588 internationally and using the passcode 1684446. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.

Use of Non-GAAP Financial Measures

This press release and the reconciliation table included herein include non-GAAP net loss, non-GAAP basic and diluted loss per share and non-GAAP operating expenses. The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding the company’s financial condition and results of operations. When viewed in conjunction with GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those that the Company uses as a basis for evaluating performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation of GAAP to non-GAAP financial measures is provided in the accompanying table entitled "Reconciliation of GAAP to Non-GAAP Financial Measures."

On May 8, 2019 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, reported its financial results for the first quarter of 2019, and provided an update on its clinical development and commercial programs (Press release, Aclaris Therapeutics, MAY 8, 2019, View Source [SID1234535940]).

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Highlights:

Aclaris submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for ATI-450, an oral MK2 inhibitor, for the treatment of rheumatoid arthritis (RA) in April 2019. It would be Aclaris’ first internally-developed novel compound to enter the clinical phase of development and its first inflammatory indication adjacent to dermatology. Aclaris expects to begin a Phase 1 clinical trial of ATI-450, an investigational compound, in the second half of 2019.

In April 2019, Aclaris completed enrollment of more than 1,000 patients across two Phase 3 pivotal clinical trials (THWART-1 and THWART-2) investigating A-101 45% Topical Solution, an investigational drug, for the treatment of common warts, and expects to complete enrollment of Aclaris’ open-label safety extension trial (WART-303) evaluating the long-term safety of A-101 45% Topical Solution during the second quarter of 2019.

During the first quarter of 2019, total net revenues were $5.0 million, which included net sales of RHOFADE (oxymetazoline hydrochloride) cream, 1% of $3.7 million, building on the positive momentum from December 2018.

In April 2019, the United States Patent and Trademark Office issued U.S. Patent No. 10,265,258 covering methods of treating alopecia areata (AA) using ruxolitinib or isotopic forms of ruxolitinib. The claims in this issued patent cover the use of an effective amount of isotopic forms of ruxolitinib, such as deuterated ruxolitinib, to treat AA. This patent is exclusively licensed to Aclaris. This represents the continued expansion of the IP estate with numerous claims directed against ruxolitinib, baricitinib, tofacitinib and decernotinib.

o advance with multiple data read outs expected during the course of the year across both our Phase 2 and Phase 3 clinical programs. Additionally, we are excited to move ATI-450, our first internally generated asset, into the clinic in the second half of this year. Our drug discovery engine continues to be productive and we look forward to developing small molecule therapeutics for many inflammatory conditions that need new treatment approaches. Finally, we are pleased with the reception to the relaunch and continued growth of RHOFADE through the first quarter," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.

Clinical Pipeline Update:

A-101 45% Topical Solution:

Aclaris’ THWART-1 and THWART-2 trials, investigating A-101 45% Topical Solution for the treatment of common warts, are progressing as planned. Aclaris has completed enrollment of more than 1,000 patients across these two trials, and topline data for both trials are expected in the second half of 2019.

An open-label safety extension trial (WART-303) evaluating the long-term safety of A-101 45% Topical Solution for the treatment of common warts is also ongoing and Aclaris expects enrollment to be completed during the second quarter of 2019.

If the results of these trials are positive, NDA submission is expected in the first half of 2020.

JAK Inhibitor Trials:

Aclaris has completed enrollment in all of the following JAK inhibitor trials:

AA-201 Topical – This ongoing Phase 2 randomized, double-blinded, parallel-group, vehicle-controlled trial is evaluating the safety, efficacy and dose response of two concentrations of ATI-502, a topical JAK1/3 inhibitor, on the regrowth of hair in 129 patients with AA. Data are expected during the second quarter of 2019 and if the results from this trial are positive, Aclaris’ next steps may include holding an end of Phase 2 meeting with the FDA, and initiating a Phase 3 trial of ATI-502 as a topical treatment for AA in the first half of 2020.

AGA-201 Topical – This ongoing Phase 2 open-label clinical trial is evaluating the safety and efficacy of ATI-502, a topical JAK1/3 inhibitor, on the regrowth of hair in 31 patients with androgenetic alopecia (AGA), also known as male/female pattern hair loss. 6-month data are expected during the second quarter of 2019 and 12-month data are

expected in the fourth quarter of 2019. If the results from this trial are positive, Aclaris expects to initiate an additional Phase 2 trial of ATI-502 for the topical treatment of AGA in the first half of 2020.

VITI-201 Topical – This ongoing Phase 2 open-label clinical trial is evaluating the safety and efficacy of ATI-502, a topical JAK1/3 inhibitor, on the repigmentation of facial skin in 34 patients with vitiligo. 6-month interim data are expected in mid-2019 and 12-month data are expected in the fourth quarter of 2019.

AD-201 Topical – This ongoing Phase 2 open-label clinical trial is evaluating the safety and efficacy of ATI-502, a topical JAK1/3 inhibitor, in 22 adult patients with moderate-to-severe atopic dermatitis (AD). Data are expected in mid-2019.

AUAT-201 Oral – This ongoing randomized, double-blinded, parallel-group, placebo-controlled trial is evaluating the safety, efficacy and dose response of three concentrations of ATI-501, an oral JAK 1/3 inhibitor, on the regrowth of hair in 87 patients with AA. Data are expected in the second half of 2019.

ATI-450 (MK2 Inhibitor) – In April, Aclaris submitted an IND for ATI-450 for the treatment of RA. Aclaris expects to initiate a Single Ascending Dose / Multiple Ascending Dose Phase 1 trial in approximately 80 patients in the second half of 2019. If the IND is allowed by the FDA, Aclaris expects to initiate a Phase 1 trial in the second half of 2019. If Aclaris successfully completes the Phase 1 trial, Aclaris expects to advance ATI-450 into Phase 2 trials in patients with rheumatoid arthritis and an additional inflammatory indication.

Commercial Update:

Based on IQVIA Xponent data for the rolling 4-week period ended April 19, 2019 compared to the rolling 4-week period ended January 25, 2019, the average weekly RHOFADE prescriptions have increased by 20%, the average number of unique RHOFADE prescribers has increased by 18% and the average number of RHOFADE prescriptions per HCP has increased by 3%.

Total prescriptions for RHOFADE were 11% higher in March 2019 as compared to February 2019, according to the IQVIA Monthly National Prescription Audit data.

RHOFADE is currently covered for 85% of commercially-insured lives and 52% of commercially-insured lives have unrestricted access, according to Managed Markets Insight & Technology data.

Aclaris received approval to market ESKATA (hydrogen peroxide) cutaneous solution, 685 mg for the treatment in adults of seborrheic keratoses that are not pedunculated and have up to a maximum diameter of 15 mm each under the brand name ESKATA in Finland, Iceland, Netherlands, Norway, Belgium and Czech Republic, and under the brand name ESKERIELE in the United Kingdom, Germany and France. Aclaris is seeking a commercial partner or partners to market the medicine as an aesthetic skin treatment in various European countries.

Financial Highlights:

Liquidity and Capital Resources

As of March 31, 2019, Aclaris had aggregate cash, cash equivalents and marketable securities of $136.8 million compared to $168.0 million as of December 31, 2018. The $31.2 million decrease during the quarter ended March 31, 2019 included:

Net loss of $37.6 million, $0.8 million of net cash used in working capital, and $0.3 million in property and equipment purchases. These uses were offset by $4.9 million of non-cash stock-based compensation expense and $2.2 million of non-cash depreciation and amortization expense.

Aclaris anticipates that its cash, cash equivalents and marketable securities as of March 31, 2019 will be sufficient to fund its operations into the fourth quarter of 2020, without giving effect to any potential new business development transactions or financing activities.

First Quarter 2019 Financial Results

Net loss was $37.6 million for the first quarter of 2019, compared to $30.2 million for the first quarter of 2018.

Net revenues were $5.0 million for the quarter ended March 31, 2019, which consisted of $3.7 million of net RHOFADE sales, $0.1 million of net ESKATA sales and $1.3 million of contract research revenues. This compared to total revenue of $1.1 million for the quarter ended March 31, 2018, all of which was contract research revenues. Cost of revenues (excluding amortization) was $2.8 million for the quarter ended March 31, 2019, compared to $1.0 million for the quarter ended March 31, 2018. Amortization of definite-lived intangibles was $1.7 million for the quarter ended March 31, 2019 and related to RHOFADE intellectual property acquired in November 2018.

Total operating expenses for the first quarter of 2019 were $37.9 million, compared to $31.1 million for the first quarter of 2018.

Research and development expenses were $19.9 million for the first quarter of 2019, compared to $13.6 million for the first quarter of 2018. The increase of $6.3 million was mainly the result of the continued advancement of Aclaris’ JAK inhibitor and common wart programs, as multiple Phase 2 trials of ATI-501 and ATI-502 and Phase 3 trials of A-101 45% Topical Solution were ongoing in the first quarter of 2019, as well as the increased headcount to support these programs. There was also an increase in preclinical work for ATI-450, Aclaris’ MK2 inhibitor, as the company prepared to file its IND in April 2019.

Sales and marketing expenses were $9.8 million for the first quarter of 2019, compared to $11.2 million for the first quarter of 2018. The decrease of $1.4 million was primarily the result of decreases in direct marketing and professional fees, as well as other commercial and personnel expenses that were incurred in the first quarter of 2018 to support the commercialization and launch of ESKATA in May 2018.

General and administrative expenses were $8.2 million for the first quarter of 2019, compared to $6.3 million for the first quarter of 2018. The increase was driven by headcount increases, professional and legal fees related to the RHOFADE acquisition in November 2018, costs incurred under a transition services agreement with Allergan related to RHOFADE, as well as increased medical affairs activities.

2019 Financial Outlook

Aclaris reiterated its 2019 expected GAAP research and development (R&D) expenses to be in the range of $61 to $64 million, including estimated stock-based compensation of $7 million. This expense guidance for R&D in 2019 contemplates the completion of Aclaris’ Phase 2 clinical trials in AA, open-label trials in AGA, vitiligo and AD, and two pivotal Phase 3 trials in common warts, as well as the further advancement of Aclaris’ preclinical pipeline compounds, including ATI-450 and ATI-1777.

Aclaris reiterated 2019 expected GAAP sales and marketing (S&M) expenses to be in the range of $37 to $40 million, including estimated stock-based compensation of $4 million. This expense guidance for S&M in 2019 contemplates all sales force costs and the selling and marketing initiatives to support Aclaris’ marketed products.

Aclaris reiterated 2019 expected GAAP general and administrative (G&A) expenses to be in the range of $29 to $31 million, including estimated stock-based compensation of $10 million. This expense guidance for G&A in 2019 contemplates additional medical affairs, legal and compliance activities to support Aclaris’ marketed products.

Company to Host Conference Call

Management will conduct a conference call at 5:00 PM ET today to discuss Aclaris’ financial results and provide a general business update. The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

On May 8, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported its results for the first quarter and provided an update on the company’s recent activities (Press release, Five Prime Therapeutics, MAY 8, 2019, View Source [SID1234535957]).

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The company also provided an update on the Phase 3 FIGHT trial testing bemarituzumab in combination with mFOLFOX6 in patients with gastric (GC) or gastroesophageal junction (GEJ) cancer that overexpresses FGFR2b.

"We and our partners have made steady progress advancing all five clinical programs in our pipeline, and we are swiftly responding to new information from the Phase 3 FIGHT trial," said Aron Knickerbocker, Chief Executive Officer of Five Prime Therapeutics. "In light of biomarker screening results from the FIGHT trial, we have made the decision to conduct an early futility analysis, which we expect to occur in the first half of 2020. We believe this is both clinically and fiscally responsible."

First Quarter 2019 Business Highlights and Milestones

Clinical Pipeline:

Bemarituzumab (FPA144) is a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immunotherapy for tumors that overexpress FGFR2b.

Based on the FIGHT trial design, patients are being selected for enrollment by: (a) tissue IHC testing (FGFR2b protein overexpression), (b) blood ctDNA testing (FGFR2 gene amplification), or (c) both IHC and ctDNA testing, as data support that patients with tumors meeting criteria in any of the three biomarker categories may benefit from the addition of bemarituzumab to front-line chemotherapy.
The FIGHT trial marks the first time that FGFR2b protein overexpression has been measured on a large scale in front-line patients with advanced gastric and GEJ cancers. Greater than 30% of patients screened have tested positive for FGFR2b overexpression by IHC alone, which is significantly higher than expected. The company expected 10% of patients to test positive by either IHC and/or ctDNA tests in the FIGHT trial. Also, the company expected that patients who tested positive for FGFR2b overexpression by IHC alone would represent a minority of the patients enrolled in the FIGHT trial, but these patients represent the vast majority of biomarker positive patients in the FIGHT trial.
Because the composition of the enrolled patient population differs from the company’s expectations, Five Prime plans to conduct an early futility analysis.
FPA150 (anti-B7-H4) is a first-in-class anti-B7-H4 antibody designed to target tumor cells by blocking B7-H4 from sending an inhibitory signal to CD8 T cells and by enhancing killing of B7-H4 overexpressing tumors through ADCC. B7-H4 is frequently overexpressed in breast, ovarian and endometrial cancers.

The company initiated dosing in the Phase 1b monotherapy expansion portion of the Phase 1a/1b trial in February 2019. The company expects to initiate dosing in May 2019 in a safety lead-in evaluating FPA150 in combination with Keytruda (pembrolizumab) in patients with advanced ovarian cancer that overexpresses B7-H4.
The abstract titled "Phase 1a/1b study of first-in-class B7-H4 antibody, FPA150, as monotherapy in patients with advanced solid tumors" was accepted for a poster presentation at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Preliminary safety data from the Phase 1a/1b trial will be presented.
Additional safety data along with preliminary efficacy data from the Phase 1b monotherapy expansion cohorts are expected to be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress.
FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion protein that uses the binding interactions of soluble CD80 to directly engage CD28 to enhance its co-stimulatory T cell activity without inducing super agonism and to block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T cell activation in the tumor microenvironment.

The company presented preclinical data regarding FPT155 during the New Drugs on the Horizon Oral Session at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
The company expects to present data from the Phase 1a dose escalation portion of the ongoing Phase 1a/1b trial at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2019.
Cabiralizumab (FPA008) is an antibody that inhibits CSF1R and has been shown to block the activation and survival of tumor-associated macrophages.

A Phase 2 trial testing the combination of cabiralizumab with Opdivo (nivolumab) with and without chemotherapy in approximately 160 patients with locally advanced or metastatic pancreatic cancer that has progressed during or after one line of chemotherapy is ongoing at sites in the U.S., Canada, Europe, Japan, Korea and Taiwan.
BMS-986258 (anti-TIM-3) is a fully-human monoclonal antibody targeting TIM-3 (T cell immunoglobulin and mucin domain-3), an immune checkpoint receptor that may limit the duration and magnitude of T cell responses. This is the first clinical candidate from the discovery collaboration between Five Prime and BMS that includes targets in three immune checkpoint pathways.

The Phase 1/2 clinical trial continues to progress.
Corporate Highlights

In January 2019, the company announced a corporate restructuring to focus resources on clinical development and late-stage research programs, primarily eliminating positions in research, pathology and manufacturing.
Summary of Financial Results and Guidance:

Cash Position: Cash, cash equivalents and marketable securities totaled $237.0 million as of March 31, 2019, compared to $270.1 million as of December 31, 2018. The decrease in cash, cash equivalents and marketable securities was primarily attributed to quarterly operating expenses that exceeded quarterly revenues.

Revenue: Collaboration and license revenue for the first quarter of 2019 decreased by $27.1 million, or 84%, to $5.3 million from $32.5 million for the first quarter of 2018. This decrease was primarily related to the $25.0 million milestone earned in the first quarter of 2018 relating to the dosing of the first patient in the BMS Phase 2 clinical trial of cabiralizumab in combination with Opdivo with and without chemotherapy.

R&D Expenses: Research and development expenses for the first quarter of 2019 decreased by $11.8 million, or 27%, to $31.8 million from $43.6 million for first quarter of 2018. This decrease was primarily related to companion diagnostic expense incurred in the first quarter of 2018, with no corresponding expense in the first quarter of 2019 and lower compensation costs, and lower clinical trial expenses that were partially offset by higher manufacturing costs related to the FPA150 program.

G&A Expenses: General and administrative expenses for both the first quarters of 2019 and 2018 were $10.5 million.

Net Loss: Net loss for the first quarter of 2019 was $35.4 million, or ($1.02) per basic and diluted share, compared to a net loss of $20.4 million, or ($0.63) per basic and diluted share, for the first quarter of 2018.

Shares Outstanding: Total shares outstanding were 34,838,684 as of March 31, 2019.

Cash Guidance: Five Prime expects full-year 2019 net cash used in operating activities to be between $117 and $122 million and estimates ending 2019 with cash, cash equivalents and marketable securities between $148 and $153 million.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 9689855. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

About the FIGHT Trial

The Phase 3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) trial is a double-blind randomized and controlled study evaluating 15 mg/kg of bemarituzumab or placebo given every two weeks combined with modified FOLFOX6 (mFOLFOX6) chemotherapy in patients with GC or GEJ cancer whose tumors overexpress FGFR2b. The primary endpoint is overall survival (OS), with key secondary endpoints being progression-free survival (PFS), objective response rate (ORR), safety and pharmacokinetic (PK) parameters.

The Phase 3 FIGHT trial is the first prospective FGFR2b-specific front-line gastric study that is evaluating bemarituzumab and mFOLFOX6 in advanced GC and GEJ cancer across clinical trial sites in Asia, the US, and Europe. Zai Lab and Five Prime have a strategic development collaboration under which Zai Lab will manage the Phase 3 portion of the FIGHT trial in China.

Unmet Need in Gastric Cancer (GC) and Gastroesophageal Junction (GEJ) cancer

Gastric cancer, including GEJ cancer, is the fifth most common cancer worldwide and third leading cause of cancer death. Gastric cancer is the second most common cancer in China.

Current first-line chemotherapy treatment delays progression by approximately six months compared to best supportive care, but median OS remains poor with literature-reported ranges of approximately 10 to 11 months and PFS of approximately six months. The presence of FGFR2b overexpression is present in patients with GC/GEJ and is associated with a worse prognosis. Few treatment options following progression are available after first-line chemotherapy, and a significant unmet need remains in the treatment of GC/GEJ worldwide.

Five Prime has partnered with two companion diagnostics companies to identify FGFR2b overexpression using an immunohistochemistry (IHC) test and FGFR2 gene amplification using circulating tumor DNA (ctDNA) analysis. Five Prime is using both assays to select patients for the FIGHT trial.

About Bemarituzumab

Bemarituzumab is a first-in-class, isoform-selective, humanized monoclonal antibody in clinical development as a targeted immunotherapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family. Bemarituzumab blocks FGFs 7, 10 and 22 from binding to FGFR2b, and has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells. Clinical results to date suggest that the specificity of bemarituzumab avoids the dose-limiting toxicities that have been seen with less selective pan-FGFR tyrosine kinase inhibitors that act on multiple FGFRs, including FGFR2.

On May 8, 2019 Adimab, LLC, the global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, reported that it has entered into an agreement to transfer the Adimab Platform to Takeda Pharmaceuticals (Takeda) for the discovery and optimization of antibody- and non-antibody-based protein therapeutics (Press release, Adimab, MAY 8, 2019, View Source [SID1234535974]). This technology transfer expands an ongoing collaboration between the two companies that was initiated in 2016.

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The Adimab transfer will provide Takeda with technology licenses at multiple research sites for discovery and optimization of novel modalities across therapeutic areas. This engineering solution provides Takeda the internal capability to engineer different complex molecules as part of its ongoing pipeline diversification strategy in biologics and other modalities.

"Takeda is building a world-class network of capabilities and partnerships to deliver the best therapeutics to address the unmet needs of specific patient populations," said Takeda’s Head of Global Biologics Research, Robert Mabry. "Adimab’s antibody discovery platform will help us diversify our pipeline beyond small molecules, expand our modalities for monoclonal antibody therapeutics, and advance other mechanisms of action enabled by antibody binders, including cell therapies, cytotoxic payloads, immunomodulatory payloads and others."

"For the past three years, we’ve been initiating approximately 35 programs per year internally; this typically involves discovery, optimization and often bispecifics, including using our proprietary CD3 antibodies," said Tillman Gerngross, Chief Executive Officer and Co-Founder at Adimab. "The Adimab Platform can be broadly applied to Takeda’s growing biologics pipeline, across many different modalities, so we’re excited to provide Takeda with the capability to advance its protein-based therapeutic efforts."

"Of the 280-plus Adimab programs initiated to date, almost one-third have come from our Platform Transfer partners, and we see the enablement of more external users as an active area of growth," added Guy Van Meter, Chief Business Officer at Adimab.

Under the terms of the agreement, Takeda will have exclusive access to unique human antibody libraries and will receive a license to the Adimab Platform for use in all therapeutic areas without any target restrictions. Takeda has also secured options to receive continued improvements to the Adimab Platform, including access to new antibody libraries. Adimab will receive an undisclosed upfront fee, future payments upon achievement of specified preclinical and clinical milestones, and royalties on therapeutic products.

On May 8, 2019 EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, reported financial results for the first quarter ended March 31, 2019, and highlighted recent corporate developments (Press release, pSivida, MAY 8, 2019, View Source [SID1234535925]).

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"The initial launches of our two commercial ocular products, DEXYCUTM and YUTIQTM, have generated a strong initial reception by treating physicians and patients, which we will look to leverage to drive sales growth in the coming quarters," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "We are now a fully-integrated, commercial-stage specialty ophthalmology company and are very pleased with the early momentum we are seeing for our two new innovative ocular products, each of which have significant market potential. We are also optimistic that we are well-positioned financially to execute on our goals following the addition of a new credit facility in February with CRG and the recent equity offering that we completed in April to support our operations through to positive cash flow in 2020."

Recent Highlights

YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye was made commercially available on February 4, 2019. YUTIQ received a preliminary recommendation from the Centers for Medicare & Medicaid Services (CMS) for a specific J-code through the Healthcare Common Procedure Coding System (HCPCS).

Ten Key Account Managers (KAMs) are dedicated to calling predominantly uveitis specialists across the U.S.

Since the February launch, approximately 95% of the top decile uveitis specialists have been visited by 10 KAMs.

Since launch, over 100 YUTIQ orders have been shipped for use in patients.

Over 300 benefit investigations have been received.

YUTIQ has been included in 9 academic formularies and is pending inclusion for an additional 11.

As of April 30, our market access initiatives have resulted in over 93% of commercial lives covered, over 75% of Medicare Advantage lives covered and 95% of Medicare Fee-For-Service lives covered.

DEXYCU (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following cataract surgery was made commercially available on March 12, 2019.

34 KAMs dedicated to the promotion of DEXYCU have focused on a phased launch program to ensure proper physician training for the preparation, application and administration of DEXYCU.

Since launch, nearly 200 surgeons in more than 150 ambulatory surgical centers (ASCs) have completed the training/certification program and are now able to purchase DEXYCU.

Since launch, over 1,200 patients have been injected with DEXYCU via the Company’s sampling program.

Since launch, over 2,000 medical professionals and office staff have been called on to discuss DEXYCU.

As of April 30, our market access initiatives have resulted in over 90% of commercial lives covered, over 75% of Medicare Advantage lives covered and 100% of Medicare Fee-For-Service lives covered.

At the 2019 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Vancouver, British Columbia, 36-month efficacy and safety data supporting YUTIQ was presented in an oral session entitled, "Treatment of Non-infectious Uveitis that Affects the Posterior Segment with a Single Intravitreal Fluocinolone Acetonide Insert (FAi) – 3-year Results." The 36-month follow up data of the Phase 3 clinical trial of YUTIQ showed a 56.3% recurrence rate of uveitis eye flares, significantly lower than eyes treated with sham (92.9%). The p-value was <0.001. 19.5% of YUTIQ treated eyes needed the assistance of adjunctive intraocular/periocular injection medication for uveitic inflammation compared to 69.0% for sham treated eyes. 34.5% of YUTIQ treated eyes needed the assistance of an adjunctive systemic steroid or immunosuppressant compared to 50.0% for sham treated eyes. Intraocular pressure (IOP) lowering drops were used in 42% of YUTIQ treated eyes and 33% of sham treated eyes with IOP lowering surgeries performed in 6% of YUTIQ treated eyes and 12% of sham treated eyes. Safety and side effects were consistent with those reported for previous analyses of earlier timepoints. These durable 36-month results continue to reinforce the potential of YUTIQ as a long-acting treatment option for patients suffering from this chronic disease.

At the 2019 American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Annual Meeting in San Diego, California, data supporting DEXYCU was presented in a paper session entitled, "Effect of Dexamethasone Intraocular Suspension 9% on IOP after Cataract Surgery: Results of Two Phase 3 Studies." An analysis of the IOP data from two Phase 3 studies of DEXYCU showed that the IOP effect of DEXYCU was comparable to short-term topically administered prednisolone acetate or placebo in cataract surgery patients. Mean IOP was only slightly elevated, to approximately 19 and 18 mmHg at postoperative Day 1 in the DEXYCU and prednisolone acetate arms, respectively, and it returned to baseline in both arms by Day 3. The proportion of patients at each measured IOP category in both studies were similar between the DEXYCU and control group cohorts. These data further support DEXYCU’s safety profile for the treatment of post-operative inflammation.

On April 1, 2019, the Company completed a public offering of 10,526,500 shares of its common stock at a public offering price of $1.90 per share. The net proceeds of the offering to the Company were approximately $18.6 million.

During April 2019, the Company exercised its option to draw an additional $15.0 million under the CRG Loan Agreement and paid a $15.0 million development milestone that was due to the former Icon security holders following the first commercial sale of DEXYCU. At April 30, 2019, the Company had $56.9 million of cash and cash equivalents.

Review of First Quarter Results Ended March 31, 2019

For the three months ended March 31, 2019, total net revenue was $2.0 million compared to $928,000 for the three months ended March 31, 2018. Net revenue from DEXYCU was $684,000, and for YUTIQ net revenue was $543,000. Neither of these products had net revenue in the corresponding quarter in 2018. Net revenue from royalties and collaborations for the three months ended March 31, 2019 totaled $785,000 compared to $928,000 in the corresponding quarter in 2018.

Operating expenses for the three months ended March 31, 2019 increased to $16.7 million from $5.6 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, professional services, stock-based compensation and amortization of the DEXYCU intangible asset. Non-operating expense, net, for the three months ended March 31, 2019 totaled $4.6 million and consisted of $777,000 of net interest expense and $3.8M from the loss on extinguishment of debt related to the pay off of the SWK term loan. Net loss for the three months ended March 31, 2019 was $19.2 million, or $0.20 per share, compared to a net loss of $7.0 million, or $0.15 per share, for the prior year quarter.

Cash and cash equivalents at March 31, 2019 totaled $43.4 million compared to $45.3 million at December 31, 2018. At April 30, 2019, the total amount outstanding under the CRG debt facility was $50 million and cash and cash equivalents as of that date were $56.9 million.

Financial Outlook

Early sales of YUTIQ and DEXYCU have been encouraging, and the Company is optimistic that existing cash and cash equivalents at April 30, 2019, and cash inflows from anticipated YUTIQ and DEXYCU product sales, will be sufficient to fund the Company’s current and planned operations through to the generation of positive cash flow in 2020.

Conference Call Information

EyePoint will host a conference call today, Wednesday, May 8, 2019, at 8:30 AM ET to discuss the results for the first quarter ended March 31 and recent operational developments. To access the conference call, please dial (877) 312-7507 from the U.S. and Canada or (631) 813-4828 (international) at least 10 minutes prior to the start time and refer to conference ID 1192368. A live webcast will be available on the Investor Relations section of the corporate website at View Source A replay of the webcast will also be available on the corporate website.