On May 12, 2023 Pulmatrix Inc (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 its first quarter financial results for 2023 and provided a corporate update on its development programs (Press release, Pulmatrix, MAY 12, 2023, View Source [SID1234631574]).

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Ted Raad, Chief Executive Officer of Pulmatrix commented, "Our focus in the first quarter was to advance both PUR1900 and PUR3100. We initiated patient dosing for the PUR1900 Phase 2b study in allergic bronchopulmonary aspergillosis (ABPA). This is an important milestone for PUR1900 which has the potential to be the first product approved for treatment of ABPA, a disease with high unmet need that affects more than 300,000 patients in the United States." Mr. Raad continued, "We also announced topline results for a Phase 1 study of PUR3100, our orally inhaled formulation of dihydroergotamine (DHE) being developed for the treatment of acute migraine. Based on these Phase 1 results, we are eager to advance PUR3100 into Phase 2 and plan to file an Investigational New Drug Application (IND) in mid-2023. We anticipate that PUR3100 will be Phase 2 ready by mid-year so that we are well positioned for potential partnership discussions. While we advance all of our programs clinically, we have been keenly focused on driving operational efficiencies and have extended our projected cash runway from second quarter 2024 into the fourth quarter of 2024."

First 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). 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 expects to report topline data from this study in mid-2024.
PUR3100

PUR3100 is under development as an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE for the acute treatment of migraine. On January 4, 2023, Pulmatrix announced PUR3100 was well-tolerated and there was 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. Pulmatrix plans to present the data at an appropriate upcoming scientific conference.
Based on the rapid systemic exposure in the therapeutic range and the improved side effect profile compared to IV dosing, Pulmatrix believes the PUR3100 formulation of DHE will be differentiated from other products approved or in development. Pulmatrix believes that PUR3100’s potential for convenient self-administration and a pharmacokinetic profile demonstrated in studies to date could address unmet needs for patients with acute migraine.
Pulmatrix plans to submit an IND in mid-2023 for a randomized, placebo-controlled, Phase 2 clinical study of PUR3100 in patients with acute migraine. The Phase 2 study would assess the safety and effectiveness of two dose levels of PUR3100, selected based on the initial Phase 1 clinical study. Initiation of the Phase 2 study is pending potential financing or partnership.
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 is expected to 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.
First Quarter 2023 Financial Results

Revenues increased $0.3 million to $1.5 million for the three months ended March 31, 2023 compared to $1.2 million for the three months ended March 31, 2022. The increase is related to the Company’s revenues recognized in accordance with the Cipla Agreement during the period.

Research and development expenses decreased $0.2 million to $3.9 million for the three months ended March 31, 2023 compared to $4.1 million for the three months ended March 31, 2022. The decrease was primarily due to decreased spend of $0.6 million in costs related to the Company’s PUR3100 program and $0.3 million in costs related to the Company’s PUR1800 program, partially offset by increased spend of $0.6 million in costs related to the Company’s PUR1900 program.

General and administrative expenses increased $0.2 million to $2.2 million for the three months ended March 31, 2023, as compared to $2.0 million for the three months ended March 31, 2022. The increase was primarily due to increased legal and professional services costs.

Pulmatrix’s total cash and cash equivalents balance as of March 31, 2023 was $30.8 million. The Company anticipates that its cash position is sufficient to fund operations into the fourth quarter of 2024.

On May 12, 2023 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers, reported that it will effect a one-for-ten reverse stock split of its authorized, issued and outstanding common stock (Press release, Xenetic Biosciences, MAY 12, 2023, View Source [SID1234631573]). Pursuant to the Certificate of Change filed with the Secretary of State of the State of Nevada, the reverse stock split will be effective at 12:01 a.m., Eastern Time, on May 15, 2023. Xenetic expects that upon the opening of trading on May 15, 2023, its common stock will trade on the Nasdaq Capital Market on a split-adjusted basis under the current trading symbol "XBIO" and the new CUSIP number 984015 602.

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No fractional shares will be issued as a result of the reverse stock split. Any fractional shares that would result from the reverse stock split will be rounded up to the nearest whole share.

Stockholders of record are not required to send in their current stock certificates or evidence of book-entry or other electronic positions for exchange. Following the effectiveness of the reverse stock split, each stock certificate and book-entry or other electronic position representing issued and outstanding shares of Xenetic’s common stock will be automatically adjusted. Those stockholders holding common stock in "street name" will receive instructions from their brokers if they need to take any action in connection with the reverse stock split. Stockholders should direct any questions concerning the reverse stock split to their broker or Xenetic’s transfer agent and registrar, Empire Stock Transfer, Inc., at [email protected].

On May 13, 2023 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that the abstract for the pivotal Phase 2 FELIX study of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) has been selected for an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2023 Congress, being held June 8 – 11, 2023, in Frankfurt (Press release, Autolus, MAY 12, 2023, View Source [SID1234631560]).

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EHA Oral Presentation:

Title: Safety and efficacy of Obecabtagene autoleucel (obe-cel, AUTO1), a fast-off rate CD19CAR in relapsed/refractory adult B-Cell acute lymphoblastic leukemia (r/r B-ALL): Topline results of the pivotal FELIX study

Session Title: Gene therapy and cellular immunotherapy – Clinical
Presentation ID: S262
Session date and time: Saturday, June 10, 2023, 11:00 – 11:15 EDT, 16:00 – 16:15 BST
Session room: Harmonie 1
Presenting Author: Dr. Claire Roddie, MD, PhD, FRCPath, Consultant Haematologist and Honorary Senior Lecturer, Cancer Institute, University College London (UCL)

On May 11, 2023 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the first quarter ended March 31, 2023 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, MAY 11, 2023, View Source [SID1234631503]).

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Chief Executive Officer John Valliant, Ph.D. commented, "In the first quarter, we further diversified our pipeline of alpha-emitting radiopharmaceuticals while progressing our multiple ongoing clinical programs. FPI-2265, our recently acquired small molecule-based radiopharmaceutical targeting prostate specific membrane antigen (PSMA) for the treatment of metastatic castration-resistant prostate cancer (mCRPC), holds the potential to be the first-to-market actinium-based PSMA agent to meet a significant and growing need for patients.

"Continuing our mission to build out a multi-asset portfolio, we received investigational new drug (IND) clearance from the FDA for FPI-2068, a bispecific antibody targeting EGFR-cMET, and the first candidate nominated under our broad collaboration agreement with AstraZeneca. We are also pleased that the first patient has been dosed in the Phase 1 study of FPI-2059 targeting neurotensin receptor 1 (NTSR1). These are both important milestones as we demonstrate the potential to develop novel targets for radiopharmaceuticals that reach beyond prostate and neuroendocrine cancers.

"In parallel with the progress across our pipeline, we are actively growing our actinium supply and manufacturing capabilities to ensure our ability to execute on our multiple clinical programs, most recently through our partnership with BWXT Medical and the recent opening of Fusion’s cGMP targeted alpha therapy (TAT) manufacturing facility," Dr. Valliant concluded.

Portfolio Update

FPI-2265

In February 2023, Fusion acquired an investigational new drug application (IND) for an ongoing Phase 2 clinical trial (the "TATCIST" trial) evaluating 225Ac-PSMA I&T, a small molecule targeting PSMA expressed in prostate cancers. The alpha-emitting radiopharmaceutical being evaluated in the TATCIST trial is now known as FPI-2265.

The TATCIST trial is designed to evaluate patients with mCRPC with progressive disease, including patients who are naïve to PSMA-targeted radiopharmaceuticals and those who have been pre-treated with 177Lu-based PSMA radiopharmaceuticals such as PLUVICTO. Fusion expects to report data on approximately 20 to 30 patients in the first quarter of 2024.

FPI-1434

In the Phase 1 trial, Fusion is exploring various dose levels of FPI-1434 as well as two dosing regimens: one with FPI-1434 alone ("hot only"), and another in which a small dose of cold antibody (naked IGF-1R antibody without the isotope) is administered prior to each dose of FPI-1434 ("cold/hot"). The Company anticipates reporting a clinical data update from the Phase 1 trial in a poster presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting on Tuesday, June 27th from 12:30 – 2:00pm CT, followed by a webcast investor presentation (details to be provided).

Fusion expects to report molecular imaging, safety, and pharmacokinetics (PK) for both the hot only and cold/hot dosing regimens. Previously reported results from the cold antibody sub-study (CASS), in conjunction with preclinical toxicity studies, demonstrated improved biodistribution with the cold/hot regimen, potentially leading to increased tumor absorbed dose compared to healthy tissues. As a result, Fusion has prioritized patient dosing with the cold/hot regimen. The Company expects to report the data across all dose escalation cohorts, including the first cohort (n=3) of the cold/hot regimen, which began after the hot only regimen and the completion of the CASS.

Chief Medical Officer Dmitri Bobilev, M.D. commented, "As the first industry study of its kind, the FPI-1434 Phase 1 clinical trial has produced key learnings about the development of antibody-based targeted alpha therapies. Given the encouraging safety, dosimetry and PK results suggesting an improved therapeutic index using the cold/hot administration, this method has become the preferred way of administration of FPI-1434 going forward. The study is currently enrolling patients in the second cohort of the cold/hot dose arm of the study."

FPI-2059

The Phase 1, non-randomized, open-label clinical trial of FPI-2059 in patients with solid tumors expressing NTSR1 is intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. Site initiation and patient screening is ongoing. Fusion plans to provide guidance on timelines for the FPI-2059 program following site activations and initial experience with patient screening and patient enrollment.

FPI-2068

In April 2023, Fusion announced U.S. Food and Drug Administration (FDA) clearance of IND applications for [225Ac]-FPI-2068 (FPI-2068) and corresponding imaging analogue [111In]-FPI-2107 (FPI-2107). Fusion is jointly developing FPI-2068 with AstraZeneca under the companies’ multi-asset collaboration agreement. FPI-2068 is a targeted alpha therapy (TAT) designed to deliver actinium-225 to various solid tumors that express EGFR and cMET. EGFR and cMET are both validated targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. Fusion plans to provide additional guidance on timelines for the FPI-2068 program following initial experience with patient screening to better predict the cadence of patient enrollment.

FPI-1966

Fusion announced that it is discontinuing the Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3. As part of a portfolio prioritization decision to focus resources on the Company’s lead program, FPI-2265, and assessment of the relative portfolio value contributions of our clinical assets, Fusion no longer plans to pursue development of FPI-1966.

Recent Updates

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In May, Fusion announced the opening of its state-of-the-art radiopharmaceutical manufacturing facility. The 27,000 square foot good manufacturing practice (GMP) compliant facility, which is located adjacent to the Company’s research and development labs, has clinical and commercial manufacturing scale capabilities designed to support the Company’s growing pipeline of targeted alpha therapies (TATs). The facility is expected to be fully operational in 2024.

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In April, Fusion announced the clearance of investigational new drug (IND) applications for [225Ac]-FPI-2068 (FPI-2068) and corresponding imaging analogue [111In]-FPI-2107 (FPI-2107) to the U.S. Food and Drug Administration (FDA).

Private Placement Financing

Fusion has agreed to sell an aggregate of approximately 4.8 million common shares to Federated Hermes Kaufmann Funds in a private placement in public equity financing (the "Offering"). The Offering is expected to result in gross proceeds to Fusion of approximately $20.0 million, before deducting offering expenses payable by Fusion.

Pursuant to the terms of the securities purchase agreement, at the closing of the Offering, Fusion will issue approximately 4.8 million of its common shares at a price of $4.18 per share. The closing of the Offering is subject to customary closing conditions and is expected to occur on or about May 15, 2023.

Upon the closing of the Offering, Fusion anticipates having sufficient cash, cash equivalents, and investments to fund its planned operating expenses and capital expenditure requirements into the second quarter of 2025.

The offer and sale of the foregoing shares are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"). The shares being issued in the private placement may not be offered or sold in the United States or Canada absent registration or pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws or pursuant to an exemption from the prospectus requirements of Canadian securities laws, as applicable. Fusion has agreed to file a registration statement with the Securities and Exchange Commission covering the resale of the shares acquired by the investors in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the shares under the resale registration statement will only be by means of a prospectus.

First Quarter 2023 Financial Results

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Cash and Investments: As of March 31, 2023, Fusion held cash, cash equivalents and investments of $221.2 million, compared to cash, cash equivalents and investments of $186.6 million as of December 31, 2022. The increase in cash, cash equivalents and investments was attributable to $60.0 million of gross proceeds received from a private placement financing that closed in February 2023.

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Collaboration Revenue: For the first quarter of 2023, Fusion recorded less than $0.1 million of revenue under the AstraZeneca collaboration agreement, compared to $0.6 million for the same period in 2022.

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R&D Expenses: Research and development expenses for the first quarter of 2023 were $15.9 million, compared to $12.7 million for the same period in 2022. The increase was primarily due to costs associated with the acquisition of the FPI-2265 Phase 2 clinical trial during the first quarter of 2023, as well as an increase in personnel-related costs.

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G&A Expenses: General and administrative expenses for the first quarter of 2023 were $9.0 million, compared to $8.4 million for the same period in 2022. The increase was primarily due to increased corporate and patent-related legal expenses, as well as an increase in personnel-related costs.

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Net Loss: For the first quarter of 2023, Fusion reported a net loss of $24.3 million, or $0.45 per share, compared with a net loss of $19.9 million, or $0.46 per share, for the same period in 2022.

On May 11, 2023 Merck KGaA reported its first quarter 2023 results (Press release, Merck KGaA, MAY 11, 2023, View Source [SID1234632868]).

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