On May 4, 2021 Cerus Corporation (Nasdaq: CERS) reported financial results for the first quarter ended March 31, 2021 (Press release, Cerus, MAY 4, 2021, View Source [SID1234579071]).

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Recent developments and highlights include:

First quarter 2021 total revenue of $29.6 million, reflecting a 20% increase over the prior year period. Total revenue was composed of (in millions, except %):

Increasing 2021 annual product revenue guidance range to $110 million to $114 million (from prior guidance of $106 million to $110 million), representing an approximately 20% to 24% increase over full year 2020 reported product revenue.
Multiple blood center partners have completed validation efforts and are now manufacturing INTERCEPT Fibrinogen Complex, with inventory ready for release to hospital customers.
The Centers for Medicare and Medicaid Services (CMS) published the Fiscal Year 2022 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule, which recommended that Intercept Fibrinogen Complex be eligible for incremental payment via a New Technology Add-On Payment (NTAP) when performed in the hospital inpatient setting.
Third module (CMC Data) submitted for CE Mark for INTERCEPT red blood cells. Fourth and final module (Manufacturing) submission anticipated by end of Q2:21.
Cash, cash equivalents, and short-term investments of $132 million at March 31, 2021.
"On the heels of our strong 2020 performance, product revenue in the first quarter of $23.4 million exceeded our expectations," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "As our U.S. customers continue to prepare for compliance with FDA’s guidance around the bacterial safety of platelets, demand for the INTERCEPT Blood System continues to build. The momentum we have in the U.S. market in particular gives us confidence that 2021 will be another year of strong growth for Cerus and we are increasing our full year product revenue guidance accordingly."

Revenue

Product revenue during the first quarter of 2021 was $23.4 million, compared to $18.6 million during the same period in 2020. Product revenue growth during the quarter benefited from increased demand for INTERCEPT platelet products in the U.S., led by adoption from the top five blood center networks in the country.

First quarter government contract revenue was $6.2 million, compared to $6.0 million during the same period in 2020. First quarter government contract revenue is primarily comprised of funding from the Biomedical Advanced Research and Development Authority (BARDA) agreement for the development of the INTERCEPT Blood System for Red Cells. The total potential value of the current BARDA agreement is $214 million, with $72.7 million cumulatively invoiced to BARDA through March 31, 2021.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins

Gross margins on product revenue during the first quarter of 2021 were 52.5% compared to 55.3% for the first quarter of 2020. The decrease in gross margin was tied to increased sales to our U.S. customers, who typically use our single dose platelet kits, which carry a less favorable gross margin contribution compared to our double dose kits, which are used more broadly outside of the U.S.

Operating Expenses

Total operating expenses for the first quarter of 2021 were $34.9 million compared to $31.7 million for the same period of the prior year.

Selling, general, and administrative (SG&A) expenses for the first quarter of 2021 totaled $19.2 million, compared to $15.9 million for the first quarter of 2020. The year-over-year increase in SG&A expenses was tied to incremental expenses associated with the launch of our INTERCEPT Fibrinogen Complex product as well as increased non-cash stock-based compensation expense.

Research and development (R&D) expenses for the first quarter of 2021 were $15.7 million, compared to $15.8 million for the first quarter of 2020. The Company continues to expect to incur costs associated with the development and testing of a new generation of INTERCEPT devices and disposable kits as well as the clinical development and pursuit of regulatory approval for the red blood cell system, among others.

Net Loss

Net loss for the first quarter of 2021 was $17.5 million, or $0.10 per basic and diluted share, compared to a net loss of $16.5 million, or $0.10 per basic and diluted share, for the first quarter of 2020. Non-cash stock-based compensation was higher by approximately $1.6 million during the first quarter of 2021 compared to the prior year period, contributing to the slightly higher net loss.

Balance Sheet

At March 31, 2021, the Company had cash, cash equivalents and short-term investments of $131.7 million, compared to $133.6 million at December 31, 2020.

Despite continued increased investments in inventory to meet customer demand, cash used for operations during Q1 2021 was narrower at $18.0 million compared to $19.8 million used during the prior year period. Offsetting this lower use were $15 million in term loan draws and $1.4 million in incremental draws from its revolving line of credit. At March 31, 2021, the Company had approximately $54.6 million in outstanding term loan debt and $9.9 million of borrowings under its revolving loan credit agreement, compared to $39.6 million in outstanding term loan debt and $8.5 million of borrowings under its revolving loan credit agreement at December 31, 2020.

Increasing 2021 Product Revenue Guidance

The Company now expects 2021 product revenue to be in the range of $110 million to $114 million, as compared to the prior range of $106 million to $110 million. The revised guidance range represents approximately 20% to 24% growth compared to 2020 reported product revenue.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 8668508. The replay will be available approximately three hours after the call through May 18, 2021.

On May 4, 2021 Incyte (Nasdaq: INCY) reported 2021 first quarter financial results, and provides a status update on the Company’s development portfolio (Press release, Incyte, MAY 4, 2021, View Source [SID1234579097]).

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"In the first quarter, we continued to make significant progress in our strategy to drive growth and diversification. While Jakafi (ruxolitinib) net sales were affected by typical seasonal effects and softer patient demand growth due to the ongoing pandemic, we remain confident in our full-year outlook. We are already seeing a return of new patient starts to pre-COVID levels and are excited for the potential launch in steroid-refractory chronic graft-versus-host disease (GVHD) later this year. The launches of Monjuvi (tafasitamab) and Pemazyre (pemigatinib) continue to progress with good uptake by both academic and community physicians," stated Hervé Hoppenot, Chief Executive Officer, Incyte. "We expect an exciting year ahead for Incyte with the potential for multiple approvals, including ruxolitinib cream in atopic dermatitis, and several regulatory filings, notably parsaclisib in NHL and ruxolitinib cream in vitiligo. We are also initiating pivotal trials across key development programs for both tafasitamab and LIMBER this year."

Portfolio Update

MPNs and GVHD – key highlights

Ruxolitinib in GVHD: The supplemental New Drug Application (sNDA) seeking approval of ruxolitinib for the treatment of steroid-refractory chronic GVHD has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA); the Prescription Drug User Fee Act (PDUFA) date is June 22, 2021. The application for approval was based on the successful randomized REACH3 trial comparing ruxolitinib with best available therapy (BAT).

LIMBER: Our Leadership In MPNs BEyond Ruxolitinib (LIMBER) development program continues to progress with once daily (QD) ruxolitinib in stability testing, and multiple ongoing and planned combination trials with ruxolitinib on track. Both monotherapy trials of INCB57643 (BET) and INCB00928 (ALK2) are ongoing, and combination trials of both agents with ruxolitinib in patients with myelofibrosis (MF) are expected to initiate later this year. Two Phase 3 trials of ruxolitinib in combination with parsaclisib as a first-line therapy for patients with MF (LIMBER-313) and as a therapy for MF patients with a suboptimal response to ruxolitinib monotherapy (LIMBER-304) are ongoing.

Indication and status

Once-a-day ruxolitinib
(JAK1/JAK2)

Myelofibrosis, polycythemia vera & GVHD: clinical pharmacology studies

ruxolitinib + parsaclisib
(JAK1/JAK2 + PI3Kδ)

Myelofibrosis: Phase 3 (first-line therapy) (LIMBER-313)

Myelofibrosis: Phase 3 (suboptimal responders to ruxolitinib) (LIMBER-304)

ruxolitinib + INCB57643
(JAK1/JAK2 + BET)

Myelofibrosis: Phase 2 in preparation

ruxolitinib + INCB00928
(JAK1/JAK2 + ALK2)

Myelofibrosis: Phase 2 in preparation

itacitinib
(JAK1)

Myelofibrosis: Phase 2 (low platelets)

ruxolitinib + CK08041
(JAK1/JAK2 + CB-Tregs)

Myelofibrosis: PoC in preparation

ruxolitinib
(JAK1/JAK2)

Steroid-refractory chronic GVHD2: sNDA under Priority Review

itacitinib
(JAK1)

Treatment-naïve chronic GVHD: Phase 3 (GRAVITAS-309)

Development collaboration with Cellenkos, Inc.
Clinical development of ruxolitinib in GVHD conducted in collaboration with Novartis
Other Hematology/Oncology – key highlights

Tafasitamab: Incyte and MorphoSys strategy to evaluate tafasitamab as a backbone therapy in multiple combinations for the treatment of various B-cell malignancies is underway. The Phase 3 inMIND trial, evaluating tafasitamab in combination with lenalidomide plus rituximab (R2) versus R2 in patients with follicular lymphoma and marginal zone lymphoma is ongoing. Preparations are underway for the Phase 3 frontMIND trial evaluating tafasitamab plus lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP alone as a first-line treatment for patients with newly diagnosed diffuse-large B-cell lymphoma (DLBCL). A proof of concept trial evaluating tafasitamab plus parsaclisib (topMIND) is expected to start later this year and a second proof of concept trial with tafasitamab plus lenalidomide in addition to plamotamab is expected to start later this year or early next.

Pemigatinib: In March, Pemazyre (pemigatinib) was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy. Additionally, the European Commission (EC) approved Pemazyre for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. The upcoming launches in Europe and Japan along with the continued launch in the U.S., signifies the first internally discovered product to be globally commercialized by Incyte. The Phase 2 tumor agnostic study of pemigatinib is ongoing and continues to enroll well.

Retifanlimab: In March, the Marketing Authorization Application (MAA) seeking approval of retifanlimab in squamous cell carcinoma of the anal canal (SCAC) was validated by the European Medicines Agency (EMA). This follows the Biologics License Application (BLA) acceptance by the FDA for the same indication earlier this year.

Indication and status

pemigatinib
(FGFR1/2/3)

CCA: Phase 2 (FIGHT-202), Phase 3 (FIGHT-302)

8p11 MPN: Phase 2 (FIGHT-203)

Tumor agnostic: Phase 2 (FIGHT-207)

tafasitamab

(CD19)1

r/r DLBCL: Phase 2 (L-MIND); Phase 3 (B-MIND); MAA under review

1L DLBCL: Phase 1b (firstMIND); Phase 3 (frontMIND) in preparation

r/r FL and r/r MZL: Phase 3 (inMIND)

r/r B-cell malignancies: PoC (topMIND) with parsaclisib (PI3Kδ) in preparation

r/r B-cell malignancies: PoC with lenalidomide and plamotamab in preparation2

parsaclisib
(PI3Kδ)

r/r FL: Phase 2 (CITADEL-203)

r/r MZL: Phase 2 (CITADEL-204)

r/r MCL: Phase 2 (CITADEL-205)
r/r FL and r/r MZL: Phase 3 (CITADEL-302) in preparation
1L MCL: Phase 3 (CITADEL-310) in preparation

retifanlimab
(PD-1)3

SCAC: Phase 2 (POD1UM-202); Phase 3 (POD1UM-303); BLA and MAA under review

MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204)

Merkel cell carcinoma: Phase 2 (POD1UM-201)

NSCLC: Phase 3 (POD1UM-304)

CCA = cholangiocarcinoma; DLBCL = diffuse large B-cell lymphoma; SCAC = squamous cell anal carcinoma; FL = follicular lymphoma; MZL = marginal zone lymphoma; MCL = mantle cell lymphoma

Development of tafasitamab in collaboration with MorphoSys
Clinical collaboration with MorphoSys and Xencor, Inc. to investigate the combination of tafasitamab plus lenalidomide in combination with Xencor’s CD20xCD3 XmAb bispecific antibody, plamotamab.
retifanlimab licensed from MacroGenics
Inflammation and Autoimmunity (IAI) – key highlights

Dermatology

Ruxolitinib cream: The NDA seeking approval of ruxolitinib cream for the treatment of atopic dermatitis (AD) has been accepted for Priority Review by the FDA and the PDUFA date has been set for June 21, 2021. The application is supported by data from the Phase 3 TRuE-AD clinical trial program – pooled results presented last month at the American Academy of Dermatology (AAD) virtual conference provided additional context regarding the impact of ruxolitinib cream on itch relief as well as sleep disturbance and sleep impairment.

Also at AAD, Incyte presented 104-week data from the Phase 2 program evaluating ruxolitinib cream in patients with vitiligo. Results showed patients on ruxolitinib cream achieved continued efficacy through 104 weeks, with a longer duration of treatment being associated with greater levels of repigmentation. Incyte also presented additional follow-up data which demonstrated a potential for maintenance of repigmentation after discontinuation of therapy (following two years of treatment with ruxolitinib cream). The two Phase 3 trials in the TRuE-V program are ongoing with results expected in Q2’21.

INCB54707: In March, Incyte initiated a Phase 2 trial evaluating INCB54707 in vitiligo. A Phase 2 trial in hidradenitis suppurativa remains ongoing.

Indication and status

ruxolitinib cream
(JAK1/JAK2)

Atopic dermatitis: NDA under Priority Review

Vitiligo: Phase 3 (TRuE-V1, TRuE-V2; recruitment complete in both trials)

INCB54707
(JAK1)

Hidradenitis suppurativa: Phase 2b

Vitiligo: Phase 2

parsaclisib
(PI3Kδ)

Autoimmune hemolytic anemia: Phase 2

INCB00928
(ALK2)

Fibrodysplasia ossificans progressiva: Phase 2 in preparation

Discovery and early development – key highlights

INCB106385/INCA00186: At AACR (Free AACR Whitepaper), Incyte shared clinical and pre-clinical data from INCB106385, our novel A2A/A2B adenosine receptor antagonist, and INCA00186, our novel CD73 monoclonal antibody—both of which highlight our ongoing efforts targeting the adenosine pathway. Incyte also presented preclinical data for our triplet combination with retifanlimab, highlighting one of our strategies to overcome adenosine mediated PD-1 suppression.

Modality

Candidates

Small molecules

INCB01158 (ARG)1, INCB81776 (AXL/MER), epacadostat (IDO1), INCB86550 (PD-L1), INCB106385 (A2A/A2B)

Monoclonal antibodies2

INCAGN1876 (GITR), INCAGN2385 (LAG-3), INCAGN1949 (OX40), INCAGN2390 (TIM-3), INCA00186 (CD73)

Bispecific antibodies

MCLA-145 (PD-L1xCD137)3

INCB01158 development in collaboration with Calithera
Discovery collaboration with Agenus
MCLA-145 development in collaboration with Merus
Partnered – key highlights

Baricitinib: In April, Incyte and Lilly announced the FDA extended the review period for the sNDA for baricitinib for the treatment of moderate to severe atopic dermatitis by three months to allow time for additional data analyses. The PDUFA action date is now expected in early Q3.

In March, Incyte and Lilly announced positive results from BRAVE-AA2 evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA), an autoimmune disorder that can cause unpredictable hair loss on the scalp, face and other areas of the body. In April, positive results from a second Phase 3 study, BRAVE-AA1, were announced, with data consistent with the findings from BRAVE-AA2. Lilly plans to submit an sNDA to the FDA for baricitinib in AA in the second half of 2021. There are currently no FDA-approved therapies for AA, highlighting the potential for baricitinib to address a significant unmet medical need.

Indication and status

baricitinib
(JAK1/JAK2)1

Atopic dermatitis: Phase 3 (BREEZE-AD); approved in EU and Japan; sNDA under review

Severe alopecia areata: Phase 3 (BRAVE-AA1, BRAVE-AA2)

Systemic lupus erythematosus: Phase 3 (BRAVE I, BRAVE II)

capmatinib
(MET)2

NSCLC (with MET exon 14 skipping mutations): Approved as Tabrecta in U.S. and Japan

Worldwide rights to baricitinib licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU and Japan for certain patients with atopic dermatitis
Worldwide rights to capmatinib licensed to Novartis
Potential therapies for patients with COVID-19

Ruxolitinib: In March, Incyte announced results from the Phase 3 DEVENT study assessing ruxolitinib plus standard of care (SoC) versus SoC in patients on mechanical ventilation with COVID-19 associated Acute Respiratory Disease Syndrome (ARDS). While results indicate a trend towards improvement in mortality in the overall study population, statistical significance was not reached in the primary endpoint (mortality due to any cause through Day 29). In the U.S. study population (91% of total study participants), however, there was a clinically and statistically significant improvement in mortality in each of the 5mg and 15mg ruxolitinib arms versus placebo.

Baricitinib: In April, Incyte and Lilly announced the primary endpoint in the Phase 3 COV-BARRIER study evaluating baricitinib in hospitalized COVID-19 patients – difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28) – was not met. There was, however, a 38% reduction in mortality by Day 28 in patients treated with baricitinib in addition to SoC. Lilly will share these data with regulatory authorities in the U.S., European Union and other geographies to evaluate next steps.

2021 First Quarter Financial Results

The financial measures presented in this press release for the three months ended March 31, 2021 and 2020 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.

Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.

Financial Highlights

Product and Royalty Revenues Product and royalty revenues for the quarter ended March 31, 2021 increased 6% over the prior year comparative period as a result of increases in Jakafi net product revenues, the launch of Pemazyre and higher product royalty revenues from Jakavi and Olumiant. The year-over-year growth rate in Jakafi net product revenues was impacted by a decline in new patient starts due to the COVID-19 pandemic, and higher patient demand and channel inventory stocking in the prior year comparative period, due to concerns over potential COVID-19 related supply disruptions.

1. Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation.
2. Non-GAAP research and development expenses exclude the cost of stock-based compensation.
3. Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation and a legal reserve.
4. Non-GAAP change in fair value of acquisition-related contingent consideration is null.

Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended March 31, 2021 decreased 72% and 74%, respectively, compared to the same period in 2020, primarily due to upfront consideration of $805 million related to our collaborative agreement with MorphoSys incurred during the quarter ended March 31, 2020. Excluding the impact of upfront consideration and milestones, research and development expense for the quarter ended March 31, 2021 increased approximately 5% compared to the same period in 2020 reflecting costs to support the continued progression of our pipeline of programs.

Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended March 31, 2021 increased 38% and 26%, respectively, compared to the same period in 2020, primarily due to expenses related to the establishment of our dermatology commercial organization and activities to support the potential launch of ruxolitinib cream for the treatment of atopic dermatitis, a $13 million reserve related to a settlement in principle in connection with the 2018 civil investigative demand from the U.S. Department of Justice, and the timing of certain expenses. Excluding the impact of the legal reserve, GAAP selling, general and administrative expenses for the quarter ended March 31, 2021 increased approximately 26% compared to the same period in 2020.

Other Financial Information

Operating income (loss) GAAP and Non-GAAP operating income (loss) for the quarter ended March 31, 2021 increased compared to the same period in 2020 primarily due to the decrease in upfront consideration and milestones related to our collaborative agreements and the growth in product and royalty revenues.

Cash, cash equivalents and marketable securities position As of March 31, 2021 and December 31, 2020, cash, cash equivalents and marketable securities totaled $2.0 billion and $1.8 billion, respectively.

2021 Financial Guidance

The Company has reaffirmed its full year 2021 financial guidance, as detailed below. Guidance does not include revenue from any potential new product launches. However, GAAP and Non-GAAP selling, general and administrative expense guidance for 2021 includes costs to support the potential launches of ruxolitinib cream as a treatment for atopic dermatitis in the U.S., pemigatinib as a treatment for cholangiocarcinoma in the EU and Japan, and tafasitamab as a treatment for DLBCL in the EU. The 2021 financial guidance does not include the impact of any potential future strategic transactions.

Unchanged

1. Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation.
2. Adjusted to exclude the estimated cost of stock-based compensation.
3. Adjusted to exclude the estimated cost of stock-based compensation and a legal reserve.

Conference Call and Webcast Information

Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13718346.

If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13718346.

The conference call will also be webcast live and can be accessed at investor.incyte.com.

On May 4, 2021 Seres Therapeutics, Inc., (Nasdaq: MCRB), a leading microbiome company developing a novel class of multifunctional bacterial therapeutics designed to functionally interact with host cells and tissues to treat disease, reported first quarter 2021 financial results and provided business updates (Press release, Seres Therapeutics, MAY 4, 2021, View Source [SID1234579113]).

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"We continue to make steady progress across our broad microbiome pipeline and we look forward to an eventful remainder of the year with important clinical milestones," said Eric Shaff, President and Chief Executive Officer of Seres. "Our SER-287 ECO-RESET Phase 2b study in mild-to-moderate ulcerative colitis patients is fully enrolled and we anticipate topline clinical results in mid-year. Following successful SER-109 Phase 3 pivotal results in patients with recurrent C. difficile infection, we continue to enroll an open label study to expand our safety database. We are very pleased with the pace of study enrollment and we anticipate achieving target enrollment during the third quarter of 2021. Completion of the required SER-109 safety database will support a Biologics License Application (BLA) filing, and potentially pave the way for SER-109 to become the first-ever FDA-approved microbiome therapeutic."

Program and Corporate Updates

SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109, an investigational oral, live microbiome therapeutic, achieved a high rate of sustained clinical response in Seres’ Phase 3 clinical trial in patients with recurrent C. difficile infection (CDI).

In August 2020, Seres announced positive topline interim results from the SER-109 Phase 3 study, ECOSPOR III. The Phase 3 study (ClinicalTrials.gov identifier: NCT03183128) was a multicenter, randomized, placebo-controlled study that enrolled 182 patients with multiply recurrent CDI. Patients were randomized 1:1 to receive either SER-109 or placebo after standard of care antibiotic treatment. Study results demonstrated that ECOSPOR III achieved the study’s primary endpoint at eight weeks and demonstrated a sustained clinical response rate of approximately 88% at eight weeks post-treatment. SER-109 resulted in a 27% absolute reduction of recurrence of CDI compared to placebo at eight weeks post-treatment, which is a relative risk reduction of 68%. SER-109 was well tolerated, with no treatment-related serious adverse events (SAEs) observed in the active arm and an adverse event profile comparable to placebo. In addition, subsequent 24-week end-of-study data indicate that the clinical effect of SER-109 is durable.

Following the topline Phase 3 study results, the FDA reaffirmed its prior position regarding the efficacy requirements to support a SER-109 BLA submission, which were exceeded by the positive SER-109 ECOSPOR III study results, as well as its prior position that the safety database should be at least 300 subjects. Seres believes that ECOSPOR III will be a single pivotal efficacy study supporting product registration and expects to reach target enrollment for the safety database study in the third quarter of 2021.

In January 2021, Seres presented Phase 3 microbiome and metabolomic endpoint data at the Keystone Symposium, which provide mechanistic support for the SER-109 efficacy observed. The study data demonstrate that SER-109 bacterial species rapidly engraft into the gastrointestinal tract; engraftment was observed as early as one week post-treatment and was durable through eight weeks, confirming the biological activity of SER-109. SER-109 administration was also observed to rapidly shifted the gastrointestinal metabolic landscape, including a significant decrease in primary bile acids and an increase in secondary bile acids, providing a mechanistic basis for inhibition of C. difficile spore germination and vegetative growth.

Seres is conducting an ongoing SER-109 open-label study in patients with recurrent CDI (ClinicalTrials.gov identifier: NCT03183128), which also admits patients with a single recurrence of CDI, to expand the SER-109 safety database. The SER-109 open label study is being enrolled at more than 100 sites across the U.S. and Canada, representing a substantial increase over those that recruited subjects into the SER-109 Phase 3 ECOSPOR III study. Additional information is available at serescdiffstudy.com.

Seres continues to execute activities necessary to enable a SER-109 BLA submission. The Company is completing supportive market assessment work, including primary research with physicians and payers, and pricing and reimbursement analyses. Seres continues to hire, train, and deploy a medical science liaison team in order to increase market education efforts. The Company believes that a substantial commercial opportunity exists for SER-109. The recurrent CDI population includes approximately 170,000 patients in the U.S.

SER-287 Phase 2b ECO-RESET study in ulcerative colitis (UC): SER-287, an oral microbiome therapeutic candidate consisting of a bacterial consortium, is designed to restructure the gastrointestinal microbiome and reduce inflammation in individuals with UC. Seres has obtained FDA Fast Track designation for SER-287 in active mild-to-moderate ulcerative colitis. SER-287 targets restructuring the microbiome to reduce proinflammatory activity and modulate UC-relevant inflammatory pathways, potentially providing a much-needed non-immunosuppressive treatment option to patients suffering from ulcerative colitis. SER-287 has the potential to be used as both a monotherapy and in combination with other approved agents.

The SER-287 Phase 2b ECO-RESET study is a randomized, placebo-controlled, three-arm induction trial that has enrolled 203 patients with active mild-to-moderate ulcerative colitis who have had inadequate response or loss of response on prior therapy. In arm A, patients receive a short course of vancomycin preconditioning followed by ten weeks of the same daily regimen used in the arm of the Phase 1b trial that showed the highest clinical remission rate. In arm B, patients receive vancomycin preconditioning followed by two weeks of the SER-287 daily regimen as in the first arm, followed by eight weeks of a lower dose of SER-287. In arm C, patients receive placebo. The study’s primary endpoint is the proportion of patients achieving clinical remission at ten weeks. The study will assess endoscopic improvement as a secondary endpoint, as well as a range of microbiome and metabolomic measures.

Seres has completed enrollment in the SER-287 Phase 2b ECO-RESET induction study in patients with active mild-to-moderate ulcerative colitis and expects to report topline clinical study results in mid-2021, with additional microbiome biomarker data becoming available in H2 2021.

Publication of SER-287 Phase 1b study results: Data from a Phase 1b study demonstrated that SER-287 administration was associated with high rates of clinical remission, endoscopic improvement, modulation of the gastrointestinal microbiome, and a favorable tolerability profile. The paper, titled "A Phase 1b Safety Study of SER-287, a Spore-Based Microbiome Therapeutic, For Active Mild-To-Moderate Ulcerative Colitis," was published as the highlighted cover article in the January 2021 print edition of the leading journal Gastroenterology.

SER-301 Phase 1b study in adults with mild-to-moderate ulcerative colitis: Seres is enrolling its Phase 1b study for SER-301, an investigational oral, rationally-designed, cultivated microbiome therapeutic, and study enrollment is ongoing. SER-301 is being evaluated in a Phase 1b study in adults with mild-to-moderate ulcerative colitis. The study is being conducted in Australia and New Zealand and is designed to enroll approximately 65 subjects. The study objectives are to evaluate drug safety and pharmacokinetics and to evaluate clinical remission and other measures of efficacy as secondary endpoints.

The consortia of bacteria in SER-301 is designed to modify the microbiome and microbe-associated metabolites in the gastrointestinal tract and modulate pathways linked to gastrointestinal inflammation and epithelial barrier integrity in patients with ulcerative colitis. SER-301 was designed using Seres’ reverse translation discovery and development platforms. The design incorporated learnings from the SER-287 Phase 1b study related to the bacterial species and the microbiome functional signatures associated with clinical efficacy. Additionally, the design incorporated insights on the engraftment dynamics of different bacteria and also the association of specific bacteria with the modulation of inflammatory and immune pathways in human subjects that have been observed across our broader clinical portfolio and confirmed using our nonclinical human-cell based assays and in vivo models.

In December 2020, Seres received a $10 million milestone payment associated with the Phase 1b SER-301 clinical study initiation from Nestlé, the Company’s ex-North American collaborative partner for this program.

SER-155 Phase 1b clinical study activities: SER-155 is an investigational oral, rationally-designed, cultivated microbiome therapeutic designed to reduce the incidence of gastrointestinal infections, bacteremia, and graft versus host disease (GvHD) in immunocompromised patients, including patients receiving allogeneic hematopoietic stem cell transplantation. SER-155 is a consortium of bacterial species selected using microbiome biomarker data and from human clinical data and nonclinical human cell-based assays and in vivo disease models. The composition aims to decrease infection and translocation of antibiotic-resistant bacteria in the gastrointestinal tract and modulate host immune responses to decrease GvHD.

The SER-155 program is supported by a CARB-X grant. Seres continues to advance SER-155 toward a Phase 1b clinical study initiation in collaboration with Memorial Sloan Kettering Cancer Center.

SER-401 program update: Seres, in collaboration with study partners, The Parker Institute for Cancer Immunotherapy and The University of Texas MD Anderson Cancer Center, had announced the voluntary discontinuation of further enrollment in the Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention (MCGRAW) study evaluating the safety and drug activity of SER-401 or fecal microbiota transplant (FMT) in combination with nivolumab in patients with metastatic melanoma. Seres has deprioritized further development of SER-401, and will prioritize rationally-designed, cultivated leads designed using the Company’s reverse translational platforms and learnings from the SER-401 trial. Future oncology programs aim to modulate host immunity/inflammation to improve response and tolerability of cancer drugs.

Upcoming investor event: Seres plans to hold a webcast and conference call on June 21, 2021 with a focus on the Company’s efforts to develop microbiome therapeutics for ulcerative colitis and the substantial opportunity for safe, effective alternative therapeutics for the over 700,000 individuals (U.S. estimate) suffering from UC. The event will include discussion of the ongoing SER-287 Phase 2b study, and SER-301 Phase 1b study. The Company anticipates topline SER-287 Phase 2b study clinical results in mid-2021, and additional microbiome biomarker data in H2 2021. Further details will be provided closer to the event.

Financial Results

Seres reported a net loss of $35.5 million for the first quarter of 2021, as compared with a net loss of $19.9 million for the same period in 2020. 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.

Research and development expenses for the first quarter of 2021 were $29.3 million, compared with $21.7 million for the same period in 2020. The research and development expenses were primarily related to Seres’ late stage SER-109 and SER-287 clinical development programs.

General and administrative expenses for the first quarter of 2021 were $11.7 million, compared with $6.1 million for the same period in 2020. General and administrative expenses were primarily due to headcount, professional fees and facility costs.

Seres ended the first quarter of 2021 with approximately $272.5 million in cash, cash equivalents and short and long-term investments.

Conference Call Information

Seres’ management will host a conference call today, May 4, 2021, 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 9967338. To join the live webcast, please visit the "Investors and News" 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 4, 2021 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported that it will release first quarter 2021 financial results and Company update after the market closes on Tuesday, May 11, 2021 (Press release, Cumberland Pharmaceuticals, MAY 4, 2021, View Source [SID1234579130]). A conference call and live internet webcast will be held on Tuesday, May 11, 2021, at 4:30 p.m. Eastern Time to discuss the results.

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To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 7973325. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

On May 4, 2021 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a biotech innovator and biologics contract manufacturing organization, reported that it has successfully resolved its lawsuit with Fraunhofer USA, Inc. ("Fraunhofer USA") (Press release, iBioPharma, MAY 4, 2021, View Source [SID1234585482]). The parties’ settlement confirms iBio’s ownership of certain intellectual property related to plant-based biopharmaceutical production. As part of the settlement, iBio granted Fraunhofer USA a fully paid-up license to use the recombinant protein manufacturing technologies that were the subject of litigation.

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Tom Isett, Chairman and CEO of iBio, said, "We are pleased to see this matter resolved and to receive compensation for the use our intellectual property. iBio remains committed to relentlessly innovating in the area of plant-made biologics, while respecting fair competition and protecting our IP. As a result, this settlement gives assurance to our licensees and clients that they can continue to depend upon us to develop and enhance our FastPharming Technologies to provide them with the speed, scalability, and eco-friendly advantages of plant-based biologics development and manufacturing from iBio."

The Settlement concludes the lawsuit that began in March 2015 in the Delaware Court of Chancery. In addition to an initial payment at signing which will cover iBio’s significant legal fees and expenses, Fraunhofer USA will make additional cash payments to iBio in March 2022 and March 2023. Certain details of the settlement are confidential.