On August 10, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported a business update and highlighted its financial results for the quarter ended June 30, 2023 (Press release, Sellas Life Sciences, AUG 10, 2023, View Source [SID1234634213]).

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"We are pleased with the solid progress across our clinical programs in the first half of the year. We expect to complete enrollment in our Phase 3 REGAL study of galinpepimut-S (GPS) in the second half of this year. In addition to our REGAL study, following a strong safety and efficacy profile for SLS009, our CDK9 inhibitor, as a monotherapy in acute myeloid leukemia (AML) in our Phase 1 study, we are particularly excited about the commencement of the Phase 2a study of SLS009 in combination with azacitidine and venetoclax in relapsed and refractory AML, for which we expect topline data in the fourth quarter of 2023," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "The focus of our clinical programs is to potentially deliver treatments to impact the lives of patients with AML, from tackling active disease to prolonging patients’ lives in the maintenance setting, and we look forward to our upcoming milestones across the AML treatment landscape."

Pipeline Update:

Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic

Phase 3 REGAL study in AML:

The interim analysis of the ongoing REGAL global Phase 3 registrational clinical trial of GPS in patients with AML who have achieved complete remission following second-line salvage therapy (CR2 patients) is expected in late 2023 or early 2024.

In April, the Independent Data Monitoring Committee (IDMC) recommended that REGAL continue as planned, following a routine, prespecified risk-benefit assessment of unblinded data from the study. The next routine IDMC meeting is scheduled for the third quarter of 2023.

A trial in progress poster titled "A randomized, open-label study of the efficacy and safety of galinpepimut-S (GPS) maintenance monotherapy compared to investigator’s choice of best available therapy (BAT) in patients with acute myeloid leukemia (AML) who have achieved complete remission (CR) after second-line salvage therapy" was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.

Phase 1/2 Study in combination with pembrolizumab (Keytruda) in ovarian cancer:

SELLAS plans to present final data at the International Gynecologic Cancer Society Annual Meeting in November 2023.The topline data showed clinical benefit of GPS and anti-PD-1 pembrolizumab combination therapy in WT1 positive relapsed or refractory platinum resistant advanced metastatic ovarian cancer patients.

Phase 1 Study in combination with nivolumab (Opdivo) in MPM:

SELLAS reported topline data from the investigator sponsored open-label Phase 1 trial for GPS combination therapy with checkpoint inhibitor nivolumab (Opdivo) for treatment of malignant pleural mesothelioma (MPM) in patients who were either refractory to or relapsed after at least one line of the standard of care therapy. Safety and efficacy endpoints were met with clinical activity and increased survival observed. Additional immune response data is expected in the fourth quarter of 2023.

SLS009: highly selective CDK9 inhibitor

Phase 1 clinical trial in relapsed/refractory (r/r) hematological malignancies:

The safety evaluation stage of the Phase 1 dose escalation clinical trial of SLS009 was completed for the highest dose cohort of AML patients who relapsed after or were refractory to available antileukemic therapies. No further dose escalations are planned in the AML group, while dose escalation continues in the lymphoma group with the addition of 75 mg and 100 mg once-a-week dose cohorts. The 100 mg cohort is planned to likely be the highest dose level for the lymphoma group. Observed clinical activity in the lymphoma group will be announced after the last dose level is complete and is expected during the third quarter of 2023.

SELLAS reported positive topline data in the second quarter of 2023 for the AML cohort as a monotherapy which supported advancement to a Phase 2a trial in AML with SLS009 in combination with azacitidine and venetoclax (aza/ven).

Phase 2a clinical trial in AML:

A Phase 2a trial was initiated studying SLS009 combination treatment with aza/ven in r/r AML patients who did not respond or stopped responding to venetoclax-based therapies. The Phase 2a clinical trial is an open label, single arm, multi-center study that is designed to evaluate safety, tolerability, and efficacy at two dose levels of SLS009. The first patients were dosed in June and topline data are expected in the fourth quarter of 2023.

Hosted a virtual expert panel discussion:

SELLAS hosted a virtual expert panel discussion on SLS009 in AML in May featuring hematology-oncology specialists Tapan Kadia, MD (The University of Texas MD Anderson Cancer Center), Joshua Zeidner, MD (University of North Carolina Lineberger Comprehensive Cancer Center), and Omer Jamy, MD (O’Neal Comprehensive Cancer Center at the University of Alabama) who discussed the treatment landscape for AML and the potential for SLS009 to address unmet medical needs for patients with relapsed and/or refractory AML. A replay of the event is available on SELLAS’ website.

Corporate Updates:

SELLAS expects to receive milestone payments totaling $13.0 million from 3D Medicines by the end of the third quarter of 2023.

Financial Results for the Second Quarter 2023:

R&D Expenses: Research and development expenses for the second quarter of 2023 were $5.9 million, compared to $5.5 million for the same period in 2022. Research and development expenses for the first half of 2023 were $13.1 million, compared to $10.1 million for the same period in 2022.The increase was primarily due to an increase in clinical trial expenses related to the ongoing Phase 3 REGAL clinical trial of GPS in AML patients and the ongoing Phase 2a and Phase 1 clinical trials of SLS009 in hematological malignancies, increased clinical and regulatory consulting, and personnel-related expenses due to increased headcount.

G&A Expenses: General and administrative expenses for the second quarter of 2023 were $3.1 million, as compared to $3.1 million for the same period in 2022. General and administrative expenses for the first half of 2023 were $7.2 million, as compared to $6.1 million for the same period in 2022. The increase was primarily due to personnel-related expenses due to increased headcount.

Acquired In-Process Research and Development: There was no acquired in-process research and development for the first half of 2023 and second quarter of 2022. Acquired in-process research and development was $10.0 million for the first half of 2022, resulting from the in-licensing of SLS009.

Net Loss: Net loss was $8.8 million for the second quarter of 2023, or a basic and diluted loss per share of $0.31, compared to a net loss of $8.4 million for the same period in 2022, or a basic and diluted loss per share of $0.41. Net loss was $19.9 million for the first half of 2023, or a basic and diluted loss per share of $0.77, compared to a net loss of $25.2 million for the same period in 2022, or a basic and diluted loss per share of $1.39.

Cash Position: As of June 30, 2023, cash and cash equivalents totaled approximately $13.8 million.

Keytruda is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and is not a trademark of SELLAS. Opdivo is a registered trademark of Bristol-Myers Squibb Company, New York, NY, USA and is not a trademark of SELLAS. The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products.

On August 10, 2023 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, reported financial results for the three and six months ended June 30, 2023 and provided a business update (Press release, Salarius Pharmaceuticals, AUG 10, 2023, View Source [SID1234634212]).

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Financial and Business Highlights

•Cash and cash equivalents were $11.5 million as of June 30, 2023, compared with $12.1 million as of December 31, 2022
•Net loss for the second quarter of 2023 was $3.9 million, or $1.43 per share, compared with net loss for the second quarter of 2022 of $4.7 million, or $2.20 per share, reflecting lower spending on seclidemstat and lower general and administrative expenses
•Raised gross proceeds of $6.0 million from a private placement of common stock and warrants, and an additional $1.7 million from an At the Market facility
•Announced plans to explore strategic alternatives and implement measures to extend resources

"While the second quarter and recent weeks were highlighted by significant advancements in both of our development programs, after a review of each program’s future funding needs and the current financial markets, the Board of Directors has made the difficult decision to limit further drug development while we explore strategic alternatives for Salarius," said David Arthur, president and chief executive officer of Salarius Pharmaceuticals.

"It was an exceptionally difficult decision to initiate our cost-savings plans and explore strategic alternatives in light of the promising early seclidemstat Ewing sarcoma clinical data, seclidemstat hematological clinical data and the recent FDA clearance to begin the SP-3164 Phase 1 trial. Unfortunately, we believe the current public financial markets make it extremely challenging to raise sufficient capital to continue meaningful clinical development activities on our own," concluded Mr. Arthur.

The Company is conducting a comprehensive review of strategic alternatives focused on maximizing shareholder value including, but not limited to, an acquisition, merger, reverse merger, divestiture of assets, licensing or other strategic transactions involving the Company. However, there is no set timetable for this process and there can be no assurance that this process will result in the Company pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms. If the Company is unable to complete a transaction it may be necessary to seek other alternatives for restructuring and resolving its liabilities, including an orderly wind-down. Salarius does not expect to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the Board of Directors has concluded that disclosure is appropriate or legally required.

In connection with the evaluation of strategic alternatives and in order to extend its resources, Salarius is implementing a cost-savings plan that includes a reduction in workforce by over 50% of its positions, with remaining employees focusing primarily on limited drug-development activities, completing the U.S. Food and Drug Administration (FDA) process to determine the clinical trial registration

requirements for the seclidemstat Ewing sarcoma program and supporting the exploration of strategic alternatives.

Second Quarter Financial Results

Research and development expenses declined to $2.4 million for the second quarter of 2023 from $2.9 million for the second quarter of 2022, primarily due to lower spending on seclidemstat offset by higher spending on SP-3164. Spending associated with seclidemstat and SP-3164 for the second quarter of 2023 was $1.1 million and $1.3 million, respectively, compared with $2.1 million and $0.8 million, respectively, for the second quarter of 2022. General and administrative expenses were $1.6 million for the second quarter of 2023, compared with $1.8 million for the second quarter of 2022, with the decline due to lower annual shareholder meeting expenses and overall compensation and benefit costs.

Year-to-Date Financial Results

Research and development expenses declined to $6.1 million for the first half of 2023 from $7.4 million for the prior-year period, primarily due to lower spending on seclidemstat offset by higher spending on SP-3164. Spending associated with seclidemstat and SP-3164 for the first half of 2023 was $2.4 million and $3.7 million, respectively, compared with $4.4 million and $3.0 million, respectively, for the prior-year period.

Net cash used for operating activities during the first half of 2023 was $7.6 million, an increase of $0.4 million from the same period a year ago. The increase is primarily due to a decrease in accounts payable.

As of June 30, 2023, Salarius had cash, cash equivalents and restricted cash of $11.5 million, compared with $12.1 million as of December 31, 2022. Current cash and cash equivalents are expected to fund the company’s planned operations through the fourth quarter of 2023 and enable the evaluation and implementation of strategic alternatives.

Seclidemstat Highlights

•The FDA removed its partial clinical hold on Salarius’ Phase 1/2 trial evaluating seclidemstat in combination with topotecan and cyclophosphamide as a potential treatment for patients with Ewing sarcoma
•The Company initiated the process with the FDA to determine the clinical trial registration requirements for the seclidemstat Ewing sarcoma program
•Previously reported interim data showed a 60% confirmed disease control rate and 7.4 months median time to tumor progression for first-relapse Ewing sarcoma patients, with no disease progression observed in either first- or second-relapse patients who achieved confirmed disease control
•The Company continues to monitor patients in the Ewing sarcoma trial and plans to release updated survival data in the coming months
•The FDA previously granted seclidemstat Fast Track, Orphan Drug and Rare Pediatric Disease designations for Ewing sarcoma
•University of Texas MD Anderson Cancer Center (MDACC) is working to restart their investigator initiated Phase 1/2 study with seclidemstat in combination with azacytidine in patients with myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML)
•Researchers at MDACC previously reported interim clinical trial results in patients who relapsed or progressed after hypomethylating agent therapy. Of eight evaluable patients, four (50%) had an objective response. These researchers reported a 90% probability of patient survival for 11 months in patients receiving seclidemstat plus azacitidine versus an expected survival of four to six months

SP-3164 Highlights

•On July 11, 2023 Salarius announced that the FDA had cleared the IND application to treat relapsed/refractory non-Hodgkin lymphoma patients with SP-3164.
•Presented NHL preclinical data at the European Hematology Association (EHA) (Free EHA Whitepaper) 2023 Hybrid Congress in June that showed:
oPotent degradation of Ikaros and Aiolos (I/A) in peripheral blood mononuclear cells (PBMC) within 2 hours of dosing, which increased in a dose- and time-dependent manner over 24 hours
oSP-3164 does not negatively impact PBMC at clinically relevant concentrations up to 96 hours post-treatment
oIn addition to having direct antitumor effects, SP-3164 also induces an anticancer immunomodulatory effect as demonstrated through the induction of cytokine secretion in human T cells following treatment
•Presented two abstracts at the AACR (Free AACR Whitepaper) Annual Meeting in April:
oOne presentation demonstrated the robust protein degradation effects of SP-3164 and its anticancer activity in NHL animal models as well as SP-3164’s compelling antitumor activity in animal models of follicular lymphoma, a type of NHL, as a single agent and in combination with venetoclax (Venclexta) or tazemetostat (Tazverik)
oThe other presentation demonstrated SP-3164’s compelling anticancer activity in cell lines and animal models of multiple myeloma. In animal models, SP-3164 demonstrated superior single-agent activity compared with the approved agents lenalidomide (Revlimid) and pomalidomide (Pomalyst), and the combination of SP-3164 and bortezomib (Velcade) was shown to be superior to the combination of pomalidomide and bortezomib.

On August 10, 2023 Rain Oncology Inc. (NasdaqGS: RAIN), (Rain), reported financial results for the second quarter ended June 30, 2023, and provides a corporate update (Press release, Rain Oncology, AUG 10, 2023, View Source [SID1234634211]).

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"Rain has been aggressively pursuing a multitude of opportunities as we seek to leverage our clinical execution capabilities and strong cash position to add value to our stockholders", said Avanish Vellanki, co-founder and chief executive officer of Rain. "Our efforts are focused on licensing or acquiring differentiated clinical-stage programs, as well as avenues to partner with companies utilizing proprietary technology that may help develop drug candidates entering the clinic. We are very excited about the progress we’ve made and recognize that it is important to act expeditiously. We will provide an update publicly on these endeavors at the appropriate time."

Second Quarter 2023 Corporate Highlights and Key Research and Development (R&D) Updates

● Corporate Activities
o Commenced review of opportunities to maximize stockholder value inclusive of the opportunity to acquire new precision oncology assets and/or novel technology platforms
o Reduced headcount to approximately 25 full-time employees, maintaining key personnel to execute on earlier-stage clinical programs and wind down the MANTRA and MANTRA-2 trials for milademetan
o Reduced cash burn through various cost saving initiatives, including headcount reduction, to extend runway through end of 2026, in the absence of a corporate transaction and further financing

● Phase 3 Dedifferentiated Liposarcoma (DD LPS) Trial (MANTRA)
o Submitted abstracts to upcoming medical conferences; anticipate presentations in 4Q23

● Phase 2 Basket Trial (MANTRA-2) of Milademetan for MDM2-Amplified Advanced Solid Tumors
o Suspended enrollment in May 2023 and trial expected to be discontinued in 4Q23
o Submitted abstract to upcoming medical conference; anticipate presentation in 4Q23

Second Quarter 2023 Financial Results

For the three and six months ended June 30, 2023, Rain reported a net loss of $22.1 million and $42.5 million, respectively, as compared to a net loss of $17.6 million and $35.0 million for the same periods in 2022, respectively.

Research and development (R&D) expenses were $15.0 million and $31.7 million for the three and six months ended June 30, 2023, respectively, as compared to $14.3 million and $27.8 million for the same periods in 2022, respectively. The increases were primarily driven by the clinical trial costs for our Phase 3 trial in DD LPS (MANTRA) and Phase 2 tumor-agnostic basket trial (MANTRA-2), as well as personnel costs. Non-cash stock-based compensation expenses included in R&D expenses were approximately $0.5 million and $1.7 million in the three and six months ended June 30, 2023, respectively, as compared to $1.2 million and $2.1 million in the same periods in 2022, respectively.

General and administrative (G&A) expenses were $5.4 million and $10.5 million for the three and six months ended June 30, 2023, respectively, as compared to $3.5 million and $7.4 million for the same periods in 2022, respectively. The increases were primarily due to higher costs associated with launch preparation in anticipation to commercially launch milademetan in LPS, personnel, legal, outside consulting, and accounting and audit fees. Non-cash stock-based compensation expense included in G&A expenses were approximately $0.3 million and $0.7 million for the three and six months ended June 30, 2023, as compared to $0.2 million and $0.6 million for the three and six months ended June 30, 2022.

In May 2023, the Company announced a reduction in its workforce in connection with the reprioritization of the Company’s clinical strategy designed to optimize Company resources. The Company recorded restructuring charges of $2.8 million in the statements of operations for the three and six months ended June 30, 2023, comprised of $2.8 million cash severance, bonus and related employee benefits and taxes of affected employees, as well as $37,000 of stock-based compensation expense related to option modification.

Total non-cash stock-based compensation expenses were approximately $0.8 million and $2.4 million for the three and six months ended June 30, 2023, respectively, as compared to $1.4 million and $2.7 million for the same periods in 2022, respectively.

As of June 30, 2023, Rain had $86.3 million in cash, cash equivalents and short-term investments. Rain anticipates that its quarter-end cash position will provide runway into year-end 2026.

As of June 30, 2023, Rain had approximately 36.4 million shares of common stock outstanding.

Second Quarter 2023 Results Conference Call and Webcast Details

The management of Rain Oncology will host a conference call and webcast for the investment community today, August 10, 2023 at 2:00 pm PT (5:00 pm ET). A live webcast may be accessed here:

View Source;tp_key=7933f8175f. The conference call can be accessed by dialing (888) 886-7786 (domestic) or (416) 764-8658 (international). The passcode for the conference call is 29873479.

Replay of the call will be available by visiting the "Events" section of the Rain website after the conclusion of the presentation and will be archived on the Rain website for 30 days.

On August 10, 2023 Quince Therapeutics, Inc. (Nasdaq: QNCX), a biotechnology company focused on acquiring, developing, and commercializing innovative therapeutics that transform patients’ lives, reported that Dirk Thye, M.D., the company’s Chief Executive Officer, will present at the Sidoti Virtual Investor Conference on Thursday, August 17, 2023, at 3:15 p.m. Eastern Time (12:15 p.m. Pacific Time) (Press release, Quince Therapeutics, AUG 10, 2023, View Source [SID1234634210]).

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A live webcast of the investor presentation will be accessible on the Events page under the News & Events heading of Quince’s Investor Relations website at ir.quincetx.com. An archive of the webcast will be available shortly following the end of the live event.

On August 10, 2023 Pulmatrix (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system disease using its patented iSPERSE technology, reported second quarter financial results for 2023 and provided a corporate update on its development programs (Press release, Pulmatrix, AUG 10, 2023, View Source [SID1234634209]).

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Ted Raad, Chief Executive Officer of Pulmatrix commented, "With our first quarter initiation of the PUR1900 Phase 2b study in allergic bronchopulmonary aspergillosis, or ABPA, our focus for the second quarter was both to continue our work on the PUR1900 trial as well as to file an Investigational New Drug Application, or IND, for a Phase 2 trial for PUR3100 for the treatment of acute migraine, which we achieved in June 2023. We anticipate starting the PUR3100 trial once appropriate financing or partnerships have been arranged. While we advance all of our programs clinically, we have focused on driving operational efficiencies and have extended our projected cash runway into the first quarter of 2025."

Second Quarter 2023 and Recent Program and Corporate Highlights

PUR1900

PUR1900 is currently in a Phase 2 trial for the treatment of ABPA in patients with asthma (). In February 2023, Pulmatrix began dosing patients for its proof-of-concept Phase 2b study of PUR1900 (itraconazole, administered as a dry powder for inhalation using iSPERSE). This Phase 2b trial is a randomized, double-blind, multi-center, placebo-controlled study to evaluate PUR1900’s efficacy and safety. The multi-center study is being conducted in the United States, United Kingdom, Australia and France. Endpoints include safety, tolerability, and potential efficacy outcomes to identify potential registrational endpoints in adult patients with asthma and ABPA. Pulmatrix anticipates topline data from this study in the third quarter of 2024.
PUR3100

The Company submitted an IND to the United States Food and Drug Administration for PUR3100 in June 2023. PUR3100 is under development as an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE for the acute treatment of migraine. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine. The Company is pursuing potential partnership opportunities.
Data from the Phase 1 study, completed last year, was presented at the American Headache Society 65th Annual Meeting in June 2023. Results showed a lower incidence of nausea, and no vomiting was observed in PUR3100 dose groups compared to intravenously (IV) administered DHE. The study also showed that PUR3100 achieved peak exposures in the targeted therapeutic range and time to maximum concentration occurred at five minutes after dosing at all dosing levels.
PUR1800

In February 2023, Pulmatrix presented complete results from a Phase 1b study of PUR1800 for acute exacerbations of chronic obstructive pulmonary disease (AECOPD). The topline data was initially announced in March 2022, at the American Academy of Allergy, Asthma & Immunology annual conference. The completed data analysis will inform the study design of a potential Phase 2 study in patients with AECOPD. Pulmatrix plans to pursue partnership opportunities to advance PUR1800 into a potential Phase 2 clinical trial.
Second Quarter 2023 Financial Results

Revenues increased $0.5 million to $1.8 million for the three months ended June 30, 2023 compared to $1.3 million for the three months ended June 30, 2022. The increase is related to the Company’s revenues recognized in accordance with the Cipla Agreement for PUR1900 during the period.

Research and development expenses decreased approximately $0.2 million to $4.2 million for the three months ended June 30, 2023 compared to $4.3 million for the three months ended June 30, 2022. The decrease was primarily due to decreased spend of $0.8 million in costs related to the Company’s PUR3100 program and $0.1 million in costs related to the Company’s PUR1800 program, partially offset by increases in spending of $0.5 million in costs related to the Company’s PUR1900 program and $0.2 million of employment and operating costs.

General and administrative expenses increased $0.1 million to $1.7 million for the three months ended June 30, 2023, compared to $1.6 million for the three months ended June 30, 2022. The increase was primarily due to increased professional services costs.

Pulmatrix’s total cash and cash equivalents balance as of June 30, 2023 was $25.8 million. The Company anticipates that its cash position, based on operational efficiencies and prioritization of spending, is sufficient to fund its operations into the first quarter of 2025.