Entry into a Material Definitive Agreement.

on June 24, 2021, Prothena Corporation plc ("Prothena") reported that Bristol Myers Squibb ("BMS") exercised its option under the terms of the ongoing global neuroscience research and development collaboration (the "Master Collaboration Agreement") to enter into an exclusive U.S. license for PRX005 (Filing, 8-K, Prothena, AUG 3, 2021, View Source [SID1234585612]).

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On July 30, 2021, Prothena entered into a U.S. License Agreement (the "Tau U.S. License Agreement") granting BMS the exclusive license to develop, manufacture and commercialize antibody products in the United States targeting Tau ("Tau Collaboration Products") for any and all uses or purposes with respect to any human or animal disease, disorder or condition.

The Tau U.S. License Agreement includes an upfront payment to Prothena of $80 million. Prothena will be eligible to receive regulatory and sales milestones up to $465 million upon achievement of certain developmental events, including regulatory approval, of a Tau Collaboration Product, and on BMS achieving certain annual net sales thresholds in the United States. Prothena also will be eligible to receive tiered royalties on net sales of Tau Collaboration Products, ranging from high single digit to high teen percentages, on a weighted average basis depending on the achieving of certain net sales thresholds. Such exercise fees, milestones and royalty payments are subject to certain reductions as specified in the Tau U.S. License Agreement.

Prothena is running the Phase 1 clinical study for PRX005. Pursuant to the terms of the Master Collaboration Agreement, BMS may elect to exercise its option to enter into an exclusive global license for PRX005 ("Tau Global Rights") following delivery of the Phase 1 clinical study results. If BMS exercises its Tau Global Rights, BMS would be obligated to pay an additional exercise fee of $55 million. The Tau Global Rights would then replace the regulatory and sales milestones under the Tau U.S. License Agreement, and would increase from $465 million to $562.5 million. The tiered royalties on net sales would remain the same.

Under the Tau U.S. License Agreement, BMS will continue to pay royalties on a product-by-product and country-by-country basis, until the latest of (i) expiration of certain patents covering the Tau Collaboration Products and (ii) an agreed period of time after the first commercial sale of the Tau Collaboration Products in the United States (the "Royalty Term").

The term of the Tau U.S. License Agreement will continue on a product-by-product and country-by-country basis until the expiration of all Royalty Terms with respect to all Tau Collaboration Products. Either party is entitled to terminate the Tau U.S. License Agreement for material breach, bankruptcy or safety reasons. Prothena is entitled to terminate the Tau U.S. License Agreement for a failure by BMS to exercise due diligence with respect to its global rights for the Tau Collaboration Products under the Master Collaboration Agreement, and for certain patent challenges by BMS. The Tau U.S. License Agreement imposes certain post-termination rights and obligations on the parties, which vary based on the reasons giving rise to the termination.

Additionally, under the Master Collaboration Agreement, BMS has options to Prothena’s programs to develop and commercialize antibodies targeting TDP-43 and an undisclosed target. For each such program, BMS may elect to exercise its option to exclusively license rights both in the U.S. and on a global basis. The exercise fees for the remaining programs are, in the aggregate, up to $270 million, and the regulatory and sales milestones are, in the aggregate, up to $1.125 billion.

The foregoing description of the Tau U.S. License Agreement is not a complete description thereof, and is qualified in its entirety by reference to the actual agreement that will be filed with the Securities and Exchange Commission as an exhibit to Prothena’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2021.

The foregoing description of the Master Collaboration Agreement is not a complete description thereof, and is qualified in its entirety by reference to the actual agreement that is filed with the Securities and Exchange Commission as Exhibit 10.8 to Prothena’s Annual Report on Form 10-K filed February 26, 2021.

Orion Corporation signs European wide marketing and distribution agreement with Marinus Pharmaceuticals for ganaxolone

On August 3, 2021 Orion Corporation ("Orion") reported that it has signed a European wide marketing and distribution agreement with Marinus Pharmaceuticals, Inc. ("Marinus") for ganaxolone, a GABAA receptor modulator being investigated in multiple rare seizure disorders (Press release, Orion , AUG 3, 2021, View Source [SID1234585627]).

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Under the terms of the agreement, Orion will have the right to sell and market ganaxolone in Europe. Orion has made an upfront payment of EUR 25 million to Marinus as a signing fee. Marinus is also eligible to receive tiered royalty ranging from low double-digits to low twenties on Orion’s future sales. In addition, Marinus is eligible to receive milestone payments upon achievement of certain development and commercialisation milestones.

Marinus will be the marketing authorisation holder and responsible for current and future clinical trials of ganaxolone. Orion will be responsible for market access in all 30 countries comprising the European Economic Area (EEA) as well as in the United Kingdom and Switzerland.

In September 2020, Marinus reported positive phase III data from a study that evaluated orally administered ganaxolone for the treatment of seizures in children and young adults with Cyclin-dependent Kinase-like 5 (CDKL5) deficiency disorder (CDD). Based on the study results, Marinus submitted a new drug application (NDA) to the United States Food and Drug Administration (FDA) for ganaxolone in CDD and expects to file a marketing authorisation application (MAA) with the European Medicines Agency (EMA) later this year. Both agencies have granted orphan drug designation to ganaxolone for the treatment of CDD.

In addition to CDD, orally administered ganaxolone is being investigated for the treatment of seizures associated with tuberous sclerosis complex (TSC) and intravenously administered ganaxolone is being investigated for the treatment of seizures associated with refractory status epilepticus (RSE). Marinus is also looking into additional indications and patient populations that could benefit from ganaxolone.

Satu Ahomäki, SVP Commercial Operations of Orion Corporation said: "We are pleased to be the partner of choice for Marinus in Europe. What we have seen so far with ganaxolone is encouraging and signifies an ongoing commitment to the rare epilepsy communities. I look forward to these efforts to advance effective medicines for these disorders. Ganaxolone could be a promising treatment option for patients suffering from rare epilepsies."

"Orion has a strong presence across Europe in rare neurological disorders, brings an extensive commercial infrastructure and is an ideal partner to introduce ganaxolone in Europe," said Scott Braunstein, M.D., Chief Executive Officer of Marinus. "This collaboration not only serves as an important step in our global development strategy for ganaxolone, it also represents the confidence Orion has in its potential. I believe that the collaboration allows both parties to share in the long term success of ganaxolone."

BostonGene Announces Publication in Blood Cancer Journal

On August 3, 2021 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported a publication in Blood Cancer Journal, a peer-reviewed journal that focuses on hematologic malignancies and related disorders (Press release, BostonGene, AUG 3, 2021, View Source [SID1234585644]). The manuscript "Lack of intrafollicular memory CD4+ T cells is predictive of early clinical failure in newly diagnosed follicular lymphoma" underscores the role of intrafollicular CD4 expression to independently predict treatment outcomes of high-risk follicular lymphoma (FL) patients.

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"We’re proud to support Mayo Clinic in its mission to predict treatment outcomes for patients with newly diagnosed follicular lymphoma"

Early event-free status (EFS) at 12 and 24 months are good indicators of subsequent prolonged survival and lengthy life expectancy in FL. However, an unmet need remains to predict early EFS at diagnosis to better treat patients with optimal therapeutics. This discovery and validation study evaluated the tumor microenvironment (TME) determinants of early failure in patients with newly diagnosed FL and integrated the results into the Follicular Lymphoma International Prognostic Index (FLIPI), the clinically-driven scoring system of survival in FL. This research study analyzed the prevalence of T-cell subsets and macrophages in the pretreatment biopsy specimens of newly diagnosed patients with FL who were prospectively enrolled in the Molecular Epidemiology Resource (MER) cohort at Mayo Clinic and the University of Iowa. To support this work, BostonGene conducted comprehensive analysis of Co-Detection by Indexing (CODEX) multiplex immunofluorescence data generated by the Villasboas Lab at Mayo Clinic to characterize intratumoral immunophenotypes. The study revealed that insufficient intrafollicular CD4 expression was the main predictor of early failure, leading to the development of a novel bio-clinical risk model (called BioFLIPI), where lack of CD4 intrafollicular expression moved patients up one FLIPI risk group, ultimately improving the identification of patients at risk for early failure at diagnosis.

"Leveraging BostonGene’s analytical capacity to explore the ultrahigh plex CODEX imaging datasets generated in our laboratory furthered our understanding of the composition and spatial distribution of immune cells within the TME," said J. C. Villasboas, MD at Mayo Clinic. "These key insights are critical to improving clinical outcomes for FL patients."

This work is the result of the research collaboration between Mayo Clinic and BostonGene to uncover key tumor characteristics that can be exploited to develop personalized therapies for lymphoma patients.

"We’re proud to support Mayo Clinic in its mission to predict treatment outcomes for patients with newly diagnosed follicular lymphoma," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "With our combined transformational technologies, we have a significant opportunity to identify patients with the highest risk of early failure and personalize treatment."

Aptose Reports Results for the Second Quarter 2021

On August 3, 2021 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated agents that target the underlying mechanisms of cancer, reported financial results for the three months ended June 30, 2021 and provided a corporate update (Press release, Aptose Biosciences, AUG 3, 2021, View Source [SID1234585668]).

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The net loss for the quarter ended June 30, 2021 was $13.5 million ($0.15 per share) compared with $15.8 million ($0.21 per share) for the quarter ended June 30, 2020. The net loss for the six months ended June 30, 2021 was $29.7 million ($0.33 per share), compared with $27.3 million ($0.36 per share) for the six months ended June 30, 2020. Total cash and cash equivalents and investments as of June 30, 2021 were $103.3 million. Based on current operations, Aptose expects that cash on hand and available capital provide the Company with sufficient resources to fund all planned Company operations including research and development into the first half of 2023.

"The progress we are seeing in our Phase 1 a/b clinical trials with luxeptinib in very challenging patient populations with AML and B-cell malignancies is especially encouraging," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "As we have begun to observe dose-dependent anti-tumor activity, we plan to continue dose escalation for extended duration to treat as many patients as possible on these higher dose levels and tackle these increasingly refractory patient populations."

Key Corporate Highlights

Luxeptinib Phase 1 a/b Clinical Study in AML – Luxeptinib is currently being evaluated in a Phase 1 a/b dose escalation clinical study in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML). In concurrence with participation at the EHA (Free EHA Whitepaper)2021 Virtual Congress (EHA) (Free EHA Whitepaper) in June, Aptose reported encouraging anti-leukemic activity in multiple patients, including a durable MRD-negative complete response in a FLT3-ITD AML patient who had relapsed after two allogeneic stem cell transplants, multiple lines of chemotherapy, and prior FLT3 inhibitor therapy. Aptose has completed the 450 and 600 mg dose levels, with some patients remaining on treatment at those levels, and has fully enrolled the 750 mg dose cohort. More information is available at www.clinicaltrials.gov (NCT04477291).

Luxeptinib Phase 1 a/b Clinical Study in B-cell Malignancies – In parallel with the trial in AML patients, luxeptinib is being evaluated in a Phase 1 a/b dose escalation clinical study in patients with B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphomas (NHL), who have failed or are intolerant to two or more lines of established therapies, including drugs such as ibrutinib, rituximab and venetoclax or for whom no other treatment options are available. Thus far, luxeptinib has been well-tolerated in patients treated at 150mg, 300mg, 450mg and 600mg BID over multiple cycles. Of the evaluable patients at these dose levels, two-thirds of them experienced various reductions of lesion size or IgM measurements compared to baseline, demonstrating measurable anti-tumor activity. Patients now are being treated at the fifth dose level of 750mg BID, which is fully enrolled. More information is available at www.clinicaltrials.gov (NCT03893682).

APTO-253 Phase 1 a/b Clinical Study in AML and MDS – As a direct inhibitor of MYC transcription, APTO-253 represents a novel approach for targeting MYC, an oncogene estimated to contribute to the majority of all human cancers, including hematologic malignancies. Given this mode of action, Aptose is expanding the target patient population to include those with relapsed or refractory B-cell malignancies characterized by chromosomal translocations involving the MYC locus. These include Burkitt’s lymphoma, double- or triple-hit diffuse large B-cell lymphomas, and other aggressive lymphomas with MYC translocations.

In the ongoing Phase 1a/b study in patients with relapsed or refractory AML and high-risk myelodysplastic syndrome (MDS), APTO-253 has been well-tolerated in five dose cohorts ranging from 20 – 150 mg/m2 over multiple cycles. Thus far, there is no evidence of drug-related adverse events, including no myelosuppression. Aptose currently is treating patients in the sixth dose cohort at 210 mg/m2 and several subsequent dose escalations are anticipated. More information is available at www.clinicaltrials.gov (NCT02267863).
RESULTS OF OPERATIONS

A summary of the results of operations for the three-month and six-month periods ended June 30, 2021 and 2020 is presented below:

The net loss for the three-month period ended June 30, 2021 decreased by $2.3 million to $13.5 million as compared with $15.8 million for the comparable period in 2020. The net loss for the six-month period ended June 30, 2021 increased by $2.4 million to $29.7 million as compared with $27.3 million for the comparable period in 2020. Components of the net loss are presented below:

Research and Development
The research and development expenses for the three-month and six-month periods ended June 30, 2021 and 2020 were as follows:

Research and development expenses increased by $3.0 million to $9.8 million for the three-month period ended June 30, 2021, as compared with $6.9 million for the comparative period in 2020. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for luxeptinib increased by approximately $1.97 million, mostly as a result of higher manufacturing costs, including costs to scale up manufacturing and research costs associated with optimizing the formulation and higher costs related to the luxeptinib AML trial, for which we received an IND allowance in June 2020.

Program costs for APTO-253 increased by approximately $263 thousand, mostly as a result of higher manufacturing costs.

Personnel-related expenses increased by $668 thousand, mostly related to new positions hired to support our clinical trials and manufacturing activities.

Stock-based compensation increased by approximately $65 thousand in the three months ended June 30, 2021, compared with the three months ended June 30, 2020, mostly related to higher total compensation expense in the current period on options issued in the first half of 2021.
Research and development expenses increased by $5.3 million to $18.1 million for the six-month period ended June 30, 2021, as compared with $12.8 million for the comparative period in 2020. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for luxeptinib increased by approximately $3.0 million, mostly as a result of higher manufacturing costs, including costs to scale up manufacturing and research costs associated with optimizing the formulation and higher costs related to the luxeptinib AML trial, for which we received an IND allowance in June 2020.

Program costs for APTO-253 increased by approximately $474 thousand, mostly as a result of higher manufacturing costs.

Personnel-related expenses increased by $1.2 million, mostly related to new positions hired to support our clinical trials and manufacturing activities.

Stock-based compensation increased by approximately $643 thousand in the six months ended June 30, 2021, compared with the six months ended June 30, 2020, mostly related to higher total compensation expense in the current period on options issued in the first half of 2021.
General and Administrative
The general and administrative expenses for the three-month and six-month periods ended June 30, 2021 and 2020 were as follows:

General and administrative expenses for the three-month period ended June 30, 2021 were $3.7 million, as compared with $9.0 million for the comparative period in 2020, a decrease of approximately $5.4 million. The decrease was primarily as a result of the following:

General and administrative expenses, other than stock-based compensation and depreciation of equipment, increased by approximately $242 thousand in the three months ended June 30, 2020, primarily as a result of higher insurance costs, professional costs and investor relations advisory costs offset by lower personnel related costs and lower office administrative costs.

Stock-based compensation decreased by approximately $5.6 million in the three months ended June 30, 2021 as compared with the three months ended June 30, 2020, mostly as a result of a lower number of options granted in the six month period ended June 30, 2021 as compared with the six month period ended June 30, 2020, that those options granted in the current period had a lower grant date fair value, and that in the comparative period the Company had issued restricted share units (RSUs) that had fully vested by the end of the comparative period. No RSUs were granted in the current period.
General and administrative expenses for the six-month period ended June 30, 2021 were $11.7 million as compared with $14.9 million for the comparative period, a decrease of approximately $3.2 million. The decrease was primarily a result of the following:

General and administrative expenses, other than share-based compensation and depreciation of equipment, increased by approximately $702 thousand in the six months ended June 30, 2021, primarily as a result of higher insurance costs, higher professional costs, higher investor relations advisory costs offset by lower office administrative costs and lower travel expenses.

Stock-based compensation decreased by approximately $3.9 million in the six months ended June 30, 2021, compared with the six months ended June 30, 2020. Stock-based compensation decreased by approximately $5.6 million mostly as a result of a lower number of options granted in the six-month period ended June 30, 2021 as compared with the six month period ended June 30, 2020, that those options granted in the current period had a lower grant date fair value, and that in the comparative period the Company had issued RSUs that had fully vested by the end of the comparative period. This decrease was offset by increased compensation of approximately $1.7 million, mostly related to the modification of option agreements of one officer as part of a separation and release agreement. Vested options of 1,679,169 with exercise prices ranging from $1.03 to $7.44 were allowed to continue to be exercisable for an additional twelve-month period, and also 504,833 options that would have expired unvested, were allowed to continue to vest for a twelve-month period. As there was no service requirement, the Company recorded $945 thousand and $663 thousand additional compensation in the current period related to these modifications for the vested and unvested options, respectively.
Conference Call and Webcast

Aptose will host a conference call to discuss results for the quarter ended June 30, 2021 today, Tuesday, August 3, 2021 at 5:00 PM ET. Participants can access the conference call by dialing 1-844-882-7834 (North American toll-free number) and 1-574-990-9707 (international/toll number) and using conference ID # 7272387. The conference call can be accessed here and will also be available through a link on the Investor Relations section of Aptose’s website at View Source An archived version of the webcast along with a transcript will be available on the Company’s website for 30 days. An audio replay of the webcast will be available approximately two hours after the conclusion of the call for seven days by dialing 1-855-859-2056 (toll free number) and 1-404-537-3406 (international/toll number), using the conference ID # 7272387.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended June 30, 2021 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

X4 Pharmaceuticals Announces Key Enrollment Milestone Achievements in Ongoing Mavorixafor Clinical Trials and Reports Second Quarter Financial Results

On August 3, 2021 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel therapies targeting diseases of the immune system resulting from dysfunction of the CXCR4 pathway, reported financial results for the second quarter and six months ended June 30, 2021 (Press release, X4 Pharmaceuticals, AUG 3, 2021, View Source [SID1234585702]). The company also announced key enrollment milestone achievements for its lead product candidate, mavorixafor, a novel, oral small molecule currently being evaluated in a Phase 3 clinical trial (4WHIM) for patients with WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome and in two Phase 1b clinical trials for patients with Waldenström’s macroglobulinemia and Severe Congenital Neutropenia (SCN) and chronic neutropenia disorders, respectively.

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"We are very encouraged by the strong interest from both the physicians and patients participating in our mavorixafor clinical programs," said Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals. "With enrollment nearly complete in the 52-week placebo-controlled Phase 3 trial in WHIM syndrome, our initial indication for mavorixafor, and continued supportive data coming from our ongoing open-label Phase 2 trial in WHIM, we are starting to ramp up our pre-commercial planning, as we now look forward to Phase 3 top-line data in the fourth quarter of 2022. In addition, we are making strong progress in our ongoing Phase 1b clinical trial in Waldenström’s and intend to announce preliminary high-dose data along with certain response measures from this trial in the fourth quarter of 2021 that we believe will build on the low- and mid-dose data we presented at EHA (Free EHA Whitepaper) this past June. Lastly, as enrollment continues in our ongoing Phase 1b trial in SCN, from which we expect the first data in the fourth quarter of 2021, we are exploring the potential broader use of mavorixafor across the larger chronic neutropenia landscape. We look forward to reporting on our continued progress with mavorixafor, presenting additional clinical, pre-clinical and prevalence data, and providing a variety of company updates later this year."

Mavorixafor Clinical Trial Updates

Phase 3 Trial in WHIM Syndrome (4WHIM):
The company reported that it has surpassed the 18-patient minimum enrollment needed for primary endpoint analyses, determination of clinical benefit, and U.S. regulatory filing (if supported by the Phase 3 data), having enrolled 23 patients to date in its ongoing Phase 3 trial in WHIM syndrome. Enrollment will be completed in the third quarter of 2021, allowing the remaining identified patients to complete screening and potential enrollment. Top-line data are expected to be announced in the fourth quarter of 2022.
The 4WHIM Phase 3 trial is a global, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the safety and efficacy of mavorixafor in 18-28 genetically confirmed WHIM patients over the course of a 52-week study with open-label extension. The primary endpoint for the trial will compare the level of circulating neutrophils relative to a clinically meaningful threshold in response to treatment with mavorixafor versus placebo over 24-hour periods. Secondary endpoints will assess infection rates, wart burden, markers of immune system function, and quality of life, among others.
The company is planning to announce new data from the open-label extension of its ongoing Phase 2 clinical trial, as well as an update on patient prevalence, and new data from research into the genetics of WHIM that will detail new insights into genotype/phenotype correlations and the identification of a new WHIM variant.
Phase 1b Trial in Waldenström’s Macroglobulinemia (WM):
The company also announced today that it has surpassed enrollment of the minimum 12 patients (Cohorts A and B) required to determine optimal dosing of mavorixafor in combination with ibrutinib in the ongoing Phase 1b clinical trial. The company is continuing enrollment in the optional Cohort C (up to an additional 6 patients).
This ongoing Phase 1b, open-label, multicenter, single-arm study examines intra-patient dose escalation, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of mavorixafor (200 mg, 400 mg, and 600 mg) in combination with ibrutinib (420 mg), both delivered orally once daily, in patients with Waldenström’s macroglobulinemia and confirmed MYD88 and CXCR4 mutations. Patients are followed for adverse events and change from baseline in IgM and hemoglobin, PK, and PD (including peripheral white blood cell counts), in addition to clinical response.
The company remains on track to announce additional dosing, efficacy, safety, and clinical response data from the ongoing trial in the fourth quarter of 2021, including patient data at the highest planned mavorixafor dose of 600 mg.
Phase 1b Trial in Severe Congenital Neutropenia (SCN):
Enrollment continues in this clinical trial, with initial data anticipated in the fourth quarter of 2021. The company expects that the initial data from this trial, in combination with additional data emerging from prior and ongoing studies that show chronic, sustained white blood cell increases across a number of patient groups treated with mavorixafor, will support the company’s exploration of opportunities for mavorixafor use across larger chronic neutropenic populations and more broadly in cellular immunodeficiencies.
Second Quarter Highlights and Upcoming Events

EHA 2021: In June, the company announced the presentation of positive data from its ongoing Phase 1b clinical trial of mavorixafor in combination with ibrutinib in Waldenström’s macroglobulinemia. Data showed robust decreases in serum IgM at low- and mid-doses of mavorixafor, suggesting best-in-class potential for this combination treatment; meaningful increases in hemoglobin levels suggested reduction in cancer burden in the bone marrow; and at 6 months, patients achieved median IgM level reductions of 60%-75%, with one patient achieving normal IgM; two of four patients (50%) had >50% reduction in serum IgM from baseline. The poster is available here; slides from the company’s associated analyst event are available here.
X4 management will be participating in the following upcoming investor conferences:
Canaccord Genuity Growth Conference – taking place virtually August 10-12, 2021
Citi Annual BioPharma Conference– taking place virtually September 8-10, 2021
Oppenheimer Fall Healthcare Life Science & Med Tech Summit – taking place virtually September 20-23, 2021
Cantor Fitzgerald Healthcare Conference – taking place virtually September 27-30, 2021
Second Quarter 2021 Financial Results

Cash, Cash Equivalents & Restricted Cash: X4 had $96.5 million in cash, cash equivalents, and restricted cash as of June 30, 2021. The company expects that its cash and cash equivalents will fund company operations into the fourth quarter of 2022.
Research and Development Expenses were $13.2 million for the second quarter ended June 30, 2021, as compared to $9.3 million for the comparable period in 2020. R&D expenses include $0.8 million and $0.5 million of certain non-cash expenses for the quarters ended June 30, 2021 and 2020, respectively.
General and Administrative Expenses were $5.8 million for the second quarter ended June 30, 2021, as compared to $5.3 million for the comparable period in 2020. G&A expenses include $1.0 million and $0.7 million of certain non-cash expenses for the quarters ended June 30, 2021 and 2020, respectively.
Net Loss: X4 reported a net loss of $19.6 million for the quarter ended June 30, 2021, as compared to a net loss of $15.1 million for the comparable period in 2020. Net losses include $1.8 million and $1.2 million of certain non-cash expenses for the quarters ended June 30, 2021 and 2020, respectively.
Conference Call and Webcast
X4 will host a conference call and webcast today at 8:30 a.m. ET to discuss these financial results and business highlights. The conference call can be accessed by dialing (866) 721-7655 from the United States or (409) 216-0009 internationally, followed by the conference ID: 2236266. The live webcast can be accessed on the investor relations section of X4 Pharmaceuticals’ website at www.x4pharma.com. Following the completion of the call, a webcast replay of the conference call will be available on the company website.