On August 3, 2022 Quanterix Corporation (NASDAQ: QTRX), a company expanding the limits of exploration with ultrasensitive biomarker detection, reported that President and Chief Executive Officer Masoud Toloue will present at the Canaccord Genuity 42nd Annual Growth Conference on Wednesday, August 10, 2022 at 1:30 p.m. ET in Boston, MA (Press release, Quanterix, AUG 3, 2022, View Source [SID1234617418]). Toloue will also host one-on-one and group meetings with institutional investors that day.

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A live webcast of the conversation will be available on the Investors section of the Quanterix website at View Source Replays of the webcast will be available on the Quanterix website for 90 days following the conference.

On August 3, 2022 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the quarter ended June 30, 2022 and provides a business update (Press release, INmune Bio, AUG 3, 2022, View Source [SID1234617515]).

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Q2 2022 and Recent Corporate Highlights

DN-TNF Platform Highlights (XPro and INB03):

Dosed the first patient in the Phase II trial using XPro (XPro1595) to treat patients with mild Alzheimer’s Disease (AD) in April. The primary endpoint will examine cognition using the Early AD/MCI Alzheimer’s Cognitive Composite (EMACC). Multiple secondary endpoints of cognition will also be measured, including CDR-SB, ADAS-COG13 and other endpoints. Data is anticipated in the second half of 2023.
FDA review of Chemistry Manufacturing and Controls (CMC) associated with a recently placed clinical hold on XPro1595 AD trials is ongoing. The Company is addressing the FDA’s manufacturing procedure query to alleviate the current hold and start the US trials sites for XPro1595 in AD as a soon as possible. While trials in the United States are on hold, INmune continues to enroll and open additional treatment sites in Australia.
INmune completed the manufacture of new doses of XPro during the quarter, enough to supply all Phase 2 programs and continue the expansion of our pre-clinical research in new disease targets for XPro therapy.
The Company presented data demonstrating XPro promotes remyelination in white matter in rodent models of Multiple Sclerosis at European Conference on Neuroinflammation.
INB03 – presented data at the AACR (Free AACR Whitepaper) Conference and HER2+ Targeted Therapy Summit showing INB03’s ability to reverse Mucin 4 (MUC4) expression, a negative predictor of treatment success, in HER2 breast cancer cell line (JIMIT-1) to re-establish sensitivity to trastuzumab and tyrosine kinase inhibitors.
Patent issued for use of XPro for central nervous systems diseases: "METHODS OF TREATING NEUROLOGICAL DISEASES," a patent directed to use of Dominant Negative Tumor Necrosis Factor variants, such as the Company’s XPro, by peripheral administration for crossing the blood-brain barrier and treating diseases of the Central Nervous System. This patent provides protection for XPro treatment in CNS diseases to 2033 with possible patent term extension of up to five additional years if requested by the Company and approved by the USPTO under 35 U.S.C. 156.
INKmune Platform:

The Company continues to monitor the high-risk myelodysplastic syndrome (MDS) cancer patient and the two compassionate use acute myeloid leukemia (AML) patients who have been treated with INKmune in a Phase 1 open label dose escalation trial.
Two weeks ago, a young patient with refractory AML after failed BMT was treated with INKmune. She received three doses of INKmune without side effects. We will be monitoring her progress closely. She is another patient with a high level of disease burden.
Received national registration for the INKmune MDS trial in the UK which allows for patients from any hospital to be enrolled in the trial at Southampton University Hospital. Additionally, the Company will be expanding its INKmune MDS trial into the EU with a new site in Athens, Greece.
Expanded ongoing INKmune treatment in MDS Phase 1 trial to include patients with AML. The Company has recently treated a new patient with AML on a compassionate basis who failed the inclusion criteria for AML patients in the trial.
Upcoming Milestones:

Initiate Xpro Phase 2 program for AD02 (mild AD) and AD03 (mild cognitive impairment) in US patients once clinical hold is lifted.
Initiate XPro Phase 2 program for treatment resistant depression (TRD), funded in part by a $2.9 million NIH grant, once clinical hold is lifted.
Initiate INKmune Phase I program in a solid tumor in 1H 2023.
Additional open-label Phase 1 trial data of INKmune in high-risk MDS/AML by 1H 2023.
Report top-line data from Phase 2 trial of Xpro in AD03 patients in 2H 2023.
Report top-line data from Phase 2 trial of XPro in AD02 patients in late 2023 or early 2024.
Report pre-clinical INKmune data in at least two new solid tumor indications, renal cell carcinoma and nasopharyngeal carcinoma.
"In April, we announced the dosing of our first patient treated with XPro1595 in the treatment of neuroinflammation as a cause of mild Alzheimer’s disease (AD) in Phase II clinical trial, AD02," stated RJ Tesi, M.D., CEO of INmune Bio. "The trial is a blinded, randomized, placebo-controlled multicenter study in Australia, in Canada and in the United States. Although the trial in the United States is currently on hold pending conclusion of the FDA’s manufacturing inquiry, we continue to enroll patients in Australia where the trial is proceeding as planned. Additionally, our plan to launch additional blinded, randomized, placebo-controlled Phase II trials in patients with mild cognitive impairment (MCI) and TRD will occur after the clinical hold is lifted.

"Our INKmune platform continues to make positive strides. We are actively expanding the INKmune program towards the treatment of solid tumors. INKmune primed NK cells have unique biologic characteristics that should make the therapy effective in solid tumors," concluded Dr. Tesi.

Financial Results for the Quarter Ended June 30, 2022:

Net loss attributable to common stockholders for the quarter ended June 30, 2022 was approximately $6.8 million, compared to approximately $6.7 million for the quarter ended June 30, 2021.

Research and development expense totaled approximately $4.2 million for the recent quarter compared to approximately $4.5 million during the quarter ended June 30, 2021.

General and administrative expense was approximately $2.2 million for the quarter compared to approximately $2.1 million during the quarter ended June 30, 2021.

Other expense was approximately $0.5 million for the quarter ended June 30, 2022 compared to approximately $ 0.1 million during the quarter ended June 30, 2021.

As of June 30, 2022, the Company had cash and cash equivalents of approximately $61.2 million.

As of August 3, 2022, the Company had approximately 17.9 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

Date: August 3, 2022
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-877-407-0784
Participant Dial-in (international): 1-201-689-8560
Conference ID: 13728540

A live audio webcast of the call can be accessed using this link: View Source

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 10, 2022 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13728540.

About XPro

XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

About INKmune

INKmune is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals akin to treatment with at least three cytokines in combination. INKmune is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma, ovarian cancer, breast cancer.

On August 3, 2022 Ipsen (Euronext: IPN; ADR: IPSEY) reported that the Phase III RESILIENT trial did not meet its primary endpoint of overall survival (OS) compared to topotecan (Press release, Ipsen, AUG 3, 2022, View Source [SID1234617336]). The trial is evaluating Onivyde (irinotecan liposomal injection) versus topotecan in patients with small cell lung cancer (SCLC), who have progressed on or after platinum-based first-line therapy treatment. RESILIENT is a Phase III trial conducted in two parts; the first part read out in 2020 confirming the safety, dosing and efficacy of Onivyde; part two is evaluating the efficacy of Onivyde versus topotecan. Detailed results from the RESILIENT trial will be presented at an upcoming medical conference.

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The analysis concluded that the primary endpoint OS was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate (ORR) in favor of Onivyde was observed. The safety and tolerability of Onivyde was consistent with its already-known safety profile, and no new safety concerns emerged. The clinical study results will be communicated with the regulatory agency.

Howard Mayer, M.D., Executive Vice President, Head of Research and Development at Ipsen, said:

"While the results from the analysis of the RESILIENT trial have not demonstrated an overall survival benefit with Onivyde in patients in second-line small cell lung cancer, we will now work with our teams to analyze the data further before decisions regarding next steps are made. These data confirm the complexities associated with treating small cell lung cancer. We wish to thank the patients, their families and healthcare teams for their participation in this clinical trial."

Onivyde is currently approved in most major markets including the U.S., Europe and Asia in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Onivyde is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas. Ipsen will continue to explore the potential of Onivyde in other areas, and the final data readout of the NAPOLI-3 Phase III trial in first-line pancreatic ductal adenocarcinoma is expected in H2 2022.

About RESILIENT

RESILIENT is a randomized, open-label Phase III trial of Onivyde (irinotecan liposome injection) versus topotecan in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy. The trial is being conducted in two parts:

Part 1: Open-label dose-finding trial of Onivyde. 30 patients were enrolled.
Part 1 Primary endpoints:
Describe the safety and tolerability of Onivyde monotherapy administered every 2 weeks
Determine the optimal Onivyde monotherapy dose for Part 2 of this trial
Part 2: A randomized, efficacy study of Onviyde versus intravenous (IV) topotecan. Approximately 450 patients were enrolled in part 2.
Part 2 objectives: To compare overall survival (OS) following treatment with Onivyde with OS following treatment with IV topotecan
The primary outcome measure is OS. Secondary outcome measures include progression-free survival, objective response rate, quality of life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-C30/LC13) dyspnea scale, quality of life assessment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) cough scale, incidence of treatment-emergent adverse events, serious adverse events and laboratory abnormalities. Safety analyses (adverse events and laboratory analyses) will be performed using the safety population, defined as all patients receiving any trial medicine.

About Onivyde (irinotecan liposome injection)

Ipsen has exclusive commercialization rights for the current and potential future indications for Onivyde in the U.S. Servier, an independent international pharmaceutical company with a strong international presence in 150 countries, is responsible for the commercialization of Onivyde outside of the U.S. and Taiwan. PharmaEngine is a commercial stage oncology company headquartered in Taipei and is responsible for the commercialization of Onivyde in Taiwan.

Indication – U.S.

Onivyde is approved by the U.S. FDA in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Limitation of use: Onivyde is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.

IMPORTANT SAFETY INFORMATION – U.S.

BOXED WARNINGS: SEVERE NEUTROPENIA and SEVERE DIARRHEA

Fatal neutropenic sepsis occurred in 0.8% of patients receiving Onivyde. Severe or life-threatening neutropenic fever or sepsis occurred in 3% and severe or life-threatening neutropenia occurred in 20% of patients receiving Onivyde in combination with 5-FU and LV. Withhold Onivyde for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment.

Severe diarrhea occurred in 13% of patients receiving Onivyde in combination with 5-FU/LV. Do not administer Onivyde to patients with bowel obstruction. Withhold Onivyde for diarrhea of Grade 2–4 severity. Administer loperamide for late diarrhea of any severity. Administer atropine, if not contraindicated, for early diarrhea of any severity.

CONTRAINDICATION

Onivyde is contraindicated in patients who have experienced a severe hypersensitivity reaction to Onivyde or irinotecan hydrochloride.

Warnings and precautions

Severe neutropenia: see boxed WARNING. In patients receiving Onivyde/5-FU/LV, the incidence of Grade 3/4 neutropenia was higher among Asian (18/33 [55%]) vs White patients (13/73 [18%]). Neutropenic fever/neutropenic sepsis was reported in 6% of Asian vs 1% of White patients

Severe diarrhea: see boxed WARNING. Severe and life-threatening late-onset (onset >24 hours after chemotherapy [9%]) and early-onset diarrhea (onset ≤24 hours after chemotherapy [3%], sometimes with other symptoms of cholinergic reaction) were observed

Interstitial lung disease (ILD): Irinotecan HCl can cause severe and fatal ILD. Withhold Onivyde patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation. Discontinue Onivyde in patients with a confirmed diagnosis of ILD

Severe hypersensitivity reactions: Irinotecan HCl can cause severe hypersensitivity reactions, including anaphylactic reactions. Permanently discontinue Onivyde in patients who experience a severe hypersensitivity reaction

Embryo-fetal toxicity: Onivyde can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during and for 1 month after Onivyde treatment

Adverse reactions

The most common adverse reactions (≥20%) were diarrhea (59%), fatigue/asthenia (56%), vomiting (52%), nausea (51%), decreased appetite (44%), stomatitis (32%), and pyrexia (23%)
The most common Grade 3/4 adverse reactions (≥10%) were diarrhea (13%), fatigue/asthenia (21%), and vomiting (11%)
Adverse reactions led to permanent discontinuation of Onivyde in 11% of patients receiving Onivyde/5- FU/LV; The most frequent adverse reactions resulting in discontinuation of Onivyde were diarrhea, vomiting, and sepsis
Dose reductions of Onivyde for adverse reactions occurred in 33% of patients receiving Onivyde/5 FU/LV; the most frequent adverse reactions requiring dose reductions were neutropenia, diarrhea, nausea, and anemia
Onivyde was withheld or delayed for adverse reactions in 62% of patients receiving Onivyde/5-FU/LV; the most frequent adverse reactions requiring interruption or delays were neutropenia, diarrhea, fatigue, vomiting, and thrombocytopenia
The most common laboratory abnormalities (≥20%) were anemia (97%), lymphopenia (81%), neutropenia (52%), increased ALT (51%), hypoalbuminemia (43%), thrombocytopenia (41%), hypomagnesemia (35%), hypokalemia (32%), hypocalcemia (32%), hypophosphatemia (29%), and hyponatremia (27%)

Drug Interactions

Avoid the use of strong CYP3A4 inducers, if possible, and substitute non-enzyme inducing therapies ≥2 weeks prior to initiation of Onivyde
Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if possible, and discontinue strong CYP3A4 inhibitors ≥1 week prior to starting therapy

Special Populations

Pregnancy and Reproductive Potential: See WARNINGS & PRECAUTIONS. Advise males with female partners of reproductive potential to use condoms during and for 4 months after Onivyde treatment
Lactation: Advise nursing women not to breastfeed during and for 1 month after Onivyde treatment
Please see full U.S. Prescribing Information including Boxed WARNING for Onivyde.

On August 3, 2022 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the second quarter of 2022 (Press release, Charles River Laboratories, AUG 3, 2022, View Source [SID1234617366]). For the quarter, revenue was $973.1 million, an increase of 6.4% from $914.6 million in the second quarter of 2021.

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Acquisitions contributed 2.3% to consolidated second-quarter revenue growth. The divestitures of the Research Models and Services operations in Japan (RMS Japan) and CDMO site in Sweden (CDMO Sweden) in October 2021 reduced reported revenue growth by 2.0%. The impact of foreign currency translation reduced reported revenue growth by 3.4%. Excluding the effect of these items, organic revenue growth of 9.5% was driven primarily by the Discovery and Safety Assessment (DSA) and Research Models and Services (RMS) business segments.

On a GAAP basis, second-quarter net income attributable to common shareholders was $109.3 million, an increase of 23.6% from net income of $88.4 million for the same period in 2021. Second-quarter diluted earnings per share on a GAAP basis were $2.13, an increase of 23.8% from $1.72 for the second quarter of 2021. The increases in GAAP net income and earnings per share were primarily driven by higher revenue and acquisition-related adjustments. In addition, GAAP net income and earnings per share included a loss from the Company’s venture capital and other strategic investments of $0.14 per share in the second quarter of 2022, compared to a gain of $0.14 per share for the same period in 2021. The Company’s venture capital and other strategic investment performance has been excluded from non-GAAP results.

On a non-GAAP basis, net income was $141.9 million for the second quarter of 2022, an increase of 6.0% from $133.8 million for the same period in 2021. Second‑quarter diluted earnings per share on a non-GAAP basis were $2.77, an increase of 6.1% from $2.61 per share for the second quarter of 2021. The non-GAAP net income and earnings per share increases were driven primarily by higher revenue and operating margin improvement, partially offset by higher interest expense and tax rate.

James C. Foster, Chairman, President and Chief Executive Officer, said, "Our second-quarter financial results reflect the sustained trends that continue to support our business, particularly our DSA and RMS business segments for which demand continues to be strong and the performance remains consistent with our initial outlook for the year. Safety Assessment continues to benefit from a growing backlog that is well above the prior-year level and solid booking activity, which support the anticipated DSA growth acceleration in the second half of the year."

"However, these robust trends were offset by headwinds from our CDMO business, as well as unfavorable changes in foreign exchange and interest rates, which have significantly intensified over the past two months. We have revised our financial outlook for 2022 to account for these escalating headwinds, resulting in lower revenue growth and earnings per share guidance for the year," Mr. Foster concluded.

Second-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $186.4 million in the second quarter of 2022, an increase of 5.5% from $176.7 million in the second quarter of 2021. Organic revenue growth of 8.5% was primarily driven by research model services, particularly the Insourcing Solutions (IS) and Genetically Engineered Models and Services (GEMS) business. Revenue growth for research models in North America and China also contributed. Revenue in China increased in the second quarter, but was negatively impacted by COVID-related restrictions that affected client order activity.

In the second quarter of 2022, the RMS segment’s GAAP operating margin decreased to 21.2% from 24.1% in the second quarter of 2021, and on a non-GAAP basis, the operating margin decreased to 24.9% from 27.4%. The GAAP and non-GAAP operating margin decreases were driven primarily by the COVID-related revenue impact in China.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $591.9 million in the second quarter of 2022, an increase of 9.6% from $540.1 million in the second quarter of 2021. Organic revenue growth of 12.9% was driven by strong demand and price increases in the Safety Assessment and Discovery Services businesses.

In the second quarter of 2022, the DSA segment’s GAAP operating margin increased to 21.8% from 19.4% in the second quarter of 2021, and on a non-GAAP basis, the operating margin increased to 25.3% from 23.5%. The GAAP and non-GAAP operating margin increases were driven primarily by operating leverage from higher revenue in both the Discovery Services and Safety Assessment businesses.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $194.8 million in the second quarter of 2022, a decrease of 1.5% from $197.8 million in the second quarter of 2021. Organic revenue growth of 1.0% reflected higher revenue in the Biologics Testing and Microbial Solutions businesses, which was effectively offset by a revenue decline in the CDMO business.

In the second quarter of 2022, the Manufacturing segment’s GAAP operating margin increased to 32.1% from 28.7% in the second quarter of 2021. The GAAP operating margin in the second quarter benefitted from acquisition-related adjustments associated with last year’s Cognate and Vigene CDMO transactions. On a non-GAAP basis, the operating margin decreased to 28.6% from 33.2% in the second quarter of 2021, primarily as a result of the CDMO business.

Reduces 2022 Guidance

The Company is reducing its 2022 financial guidance, due primarily to headwinds associated with the CDMO business, foreign exchange due to the strengthening U.S. dollar, and interest expense due to the rising interest rate environment.

Reported revenue growth guidance is being reduced by 450 basis points to reflect unfavorable movements in foreign currency translation, as well as a lower revenue growth rate in the Manufacturing segment, driven principally by the CDMO business.

Organic revenue growth guidance for 2022 is being reduced by 250 basis points, also driven largely by the CDMO business. The Company continues to expect the organic revenue growth rates for the DSA and RMS segments will be in line with the initial outlooks for the year.

The Company is also reducing GAAP and non-GAAP earnings per share guidance primarily to reflect the headwinds from the CDMO business and foreign exchange, as well as higher interest expense. These factors will be partially offset by discretionary cost controls.

The Company’s updated guidance for revenue growth, earnings per share, and cash flow is as follows:

Footnotes to Guidance Table:

(1) Organic revenue growth is defined as reported revenue growth adjusted for completed acquisitions and divestitures, the 53rd week in 2022, and foreign currency translation.
(2) These adjustments are related to the evaluation and integration of acquisitions and divestitures, and primarily include transaction, advisory, certain third-party integration costs, and certain costs associated with acquisition-related efficiency initiatives, offset by adjustments related to contingent consideration and certain indirect tax liabilities.
(3) Venture capital and other strategic investment performance only includes recognized gains or losses. The Company does not forecast the future performance of these investments.
(4) These items primarily relate to charges associated with U.S. and international tax legislation that necessitated changes to the Company’s international financing structure; certain third-party legal costs related to (a) environmental litigation related to the Microbial Solutions business and (b) responses to a U.S. government industry-wide supply chain management inquiry applicable to our Safety Assessment business; and severance and other costs related to the Company’s efficiency initiatives.

Webcast

Charles River has scheduled a live webcast on Wednesday, August 3rd, at 9:30 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website.

Non-GAAP Reconciliations

The Company reports non-GAAP results in this press release, which exclude often-one-time charges and other items that are outside of normal operations. A reconciliation of GAAP to non-GAAP results is provided in the schedules at the end of this press release.

On August 3, 2022 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [("Merrimack" or the "Company")] reported that Ipsen, SA ("Ipsen") has issued its primary analysis of the results of its Phase 3 trial of Onivyde (irinotecan liposomal injection) as a treatment of second line small cell lung cancer (SCLC) (Press release, Merrimack, AUG 3, 2022, View Source [SID1234617382]). The press release indicates that the "the primary endpoint OS was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate (ORR) in favor of Onivyde was observed. The safety and tolerability of Onivyde was consistent with its already-known safety profile, and no new safety concerns emerged. The clinical study results will be communicated with the regulatory agency." Ipsen indicated in its update that it will analyze the data further before making decisions about next steps.

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"We will continue to monitor updates from Ipsen regarding the SCLC program," said Gary Crocker, Chairman and CEO of Merrimack Pharmaceuticals. "Ipsen also reported in its recent H1 2022 financial results update provided on July 29, 2022, that it expects to publicly report its top line data from its continuing Phase 3 study of Onivyde in first line pancreatic ductal adenocarcinoma before the end of 2022.