On May 14, 2024 Lumos Pharma, Inc., a clinical stage biopharmaceutical company focused on therapeutics for rare diseases, reported the outcome from its End-of-Phase 2 meeting with the FDA, provided a clinical programs update, and reported financial results for the quarter ended March 31, 2024 (Press release, Lumos Pharma, MAY 15, 2024, View Source [SID1234643324]).

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"We are pleased to announce that, earlier this quarter, we had a very productive End-of-Phase 2 meeting with the FDA," said Rick Hawkins, Chairman and CEO of Lumos Pharma. "In this review, the FDA recognized LUM-201’s unique mechanism as a growth hormone secretagogue and acknowledged the use of a placebo-controlled clinical trial design as an appropriate option for a LUM-201 Phase 3 trial. Based on the FDA’s feedback, we plan to move forward with a proposal for a single Phase 3 study that will be a double-blinded, placebo-controlled clinical trial with a 2:1 randomization in approximately 150 patients. We expect to finalize design details with the FDA in the third quarter and to be in position to initiate this trial before the end of this year."

"In addition to our encouraging engagement with the FDA, we are also very pleased to share updated data from our Phase 2 OraGrowtH trials. These data continue to show that LUM-201 produces a significant increase in growth from baseline in annualized height velocity (AHV) at 6 and 12 months in per protocol analysis. Combined data also suggest durable benefit out to 24 months."

"We believe these developments have positioned us to advance LUM-201 toward both a Phase 3 registrational trial and potential approval of LUM-201 as the first oral therapeutic for moderate pediatric growth hormone deficiency," Rick Hawkins concluded.

Recent Highlights

•End of Phase 2 Meeting Held with FDA
◦FDA indicated that a placebo-controlled trial design is an appropriate option for a Phase 3 trial for LUM-201. We believe this reflects FDA’s recognition of unique qualities of LUM-201’s mechanism of action as a growth hormone secretagogue.
◦Proposal for a Phase 3 trial to include a 12-month double-blinded, placebo-controlled design with 2:1 randomization, ~150 patients with the placebo-controlled portion of the study lasting six months, which we believe will improve the likelihood of success when compared to a non-inferiority study.
◦Planning is ongoing, and the Company expects to initiate a Phase 3 trial of LUM-201 in Q4 2024, subject to FDA approval.
•Updated LUM-201 Data from Combined OraGrowtH210 and OraGrowtH212 Trials

Exhibit 99.1

◦Additional data continue to show durable LUM-201 treatment effect to 12 and 24 months.
◦Full 12-month data from OraGrowtH210 demonstrated LUM-201 produces significant increase in growth from baseline with AHVs of 8.2 cm/yr (N=22) and 7.6 cm/yr (N=21) at 6 and 12 months, respectively, at the 1.6 mg/kg dose vs. 4.7 cm/yr baseline growth (N=13).*
◦Full 12-month data from OraGrowtH210 continued to show durable effect to 12 months for all LUM-201 cohorts and 1.6 mg/kg/day as optimal dose to advance to Phase 3.
◦Updated combined data from OraGrowtH210 and OraGrowtH212 trials continued to demonstrate LUM-201 AHV durable to 24 months with per protocol-24M (N=12) AHV of 8.1 cm/yr and 7.3 cm/yr at 12 and 24 months, respectively .
◦More moderate year-2 decline in AHV of 9.9% for LUM-201 compared to year-2 decline in AHV of 19.7% observed in historical rhGH benchmarks likely due to LUM-201 restoration of GH and IGF-1 to normal levels via amplification of physiologic pulsatile secretion of growth hormone within the natural endocrine feedback loop.
◦Investigational safety profile continues to be favorable.
•Data from Phase 2 OraGrowtH210 and OraGrowtH212 Trials Presented at Medical Meetings in US and Europe
◦Pediatric Endocrinology Society (PES)
◦10th International Congress of the Growth Hormone Research Society (GRS)
◦European Congress of Endocrinology (ECE)
◦Data presented at these medical conferences demonstrate that by augmenting the natural pulsatile secretion of growth hormone LUM-201 produces comparable growth to injectable rhGH with significantly less exposure to circulating growth hormone.
•Additional Data from Phase 2 OraGrowtH Trials to be Presented in Q2 2024
◦Full 12-Month OraGrowtH212 data, additional analyses of OraGrowtH210 data, and updated combined 24-month data to be presented in Q2 2024
◦Two abstracts accepted for poster presentation at the Endocrine Society (ENDO) Annual Meeting

*Baseline AHV data were not required for enrollment; baseline data available for N=13 subjects.

Financial Results for Quarter Ended March 31, 2024

Cash Position – Lumos Pharma ended the quarter on March 31, 2024, with cash, cash equivalents, and short-term investments totaling $23.2 million, as compared to $36.1 million on December 31, 2023. Cash on hand is expected to support operations through Q3 2024, which is inclusive of Phase 3 planning and preparatory activities.

R&D Expenses – Research and development expenses for the quarter ended March 31, 2024 were $7.2 million, an increase of $2.9 million compared to the same period in 2023, primarily due to increases of $2.0 million in licensing expense, $0.8 million in clinical trial expenses and $0.2 million in consulting expenses, offset by a decrease of $0.1 million in personnel-related expenses.

G&A Expenses – General and administrative expenses for the quarter ended March 31, 2024 were $3.8 million, a decrease of $0.6 million compared to the same period in 2023, primarily due to decreases of $0.4 million in licensing expenses, $0.1 million in travel expenses, $0.1 million in consulting expenses and $0.1 million in other expenses, offset by an increase of $0.1 million in personnel-related expenses.

Net Loss – The net loss for the quarter ended March 31, 2024, was $10.4 million compared to a net loss of $7.3 million for the same period in 2023.

On May 15, 2024 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies in oncology that address cancer immune resistance, reported financial results for the three months ended March 31, 2024 and provided a corporate update (Press release, Kineta, MAY 15, 2024, View Source;utm_medium=rss&utm_campaign=kineta-reports-first-quarter-2024-financial-results-and-provides-update-on-its-ongoing-phase-1-2-vista-101-clinical-trial-and-corporate-activities [SID1234643323]).

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In February 2024, the Company announced a significant corporate restructuring to substantially reduce expenses and preserve cash. The restructuring included a significant workforce reduction and the suspension of enrollment of new patients in its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 in patients with advanced solid tumors. Patients currently enrolled in the trial will be permitted to continue to participate. The Company announced the restructuring as a result of certain investors indicating that they would not fulfill their April 2024 funding obligation in the previously disclosed private placement financing. In connection with the restructuring, the Company announced that it is exploring strategic alternatives to maximize stockholder value.

"The Company announced additional clinical updates on the progress of the KVA12123 monotherapy and combination therapy results during the first quarter of 2024. We continue to be pleased with these early clinical results as well as the accompanying biomarkers and immune cell data sets. We look forward to sharing additional clinical updates in the second quarter and we will continue to explore strategic alternatives," said Craig Philips, President of Kineta.

RECENT CORPORATE HIGHLIGHTS

Phase 1/2 VISTA-101 Trial of KVA12123 in Patients with Solid Cancer Tumors (clinical data was announced in March 2024)

Efficacy

Announced positive KVA12123 monotherapy safety data from its ongoing Phase 1/2 VISTA-101 clinical trial in patients with advanced solid tumors.
Monotherapy Dose Escalation (3 – 300 mg KVA12123 Q2W)
Of 21 patients enrolled, 12 received at least one baseline and one follow up scan.
Best overall response (BOR) in nine of 12 patients is currently stable disease among patients with at least one follow-up scan with a mean duration of 15 weeks.
One patient with non-small cell lung cancer that failed six prior lines of therapy, including checkpoint inhibitor (CPI) therapy, has experienced a stable disease lasting 28 weeks.
Nine participants remain on-treatment.
Combination Therapy Dose Escalation (30-100 mg KVA12123 Q2W, 400 mg pembrolizumab Q6W).
Of nine patients enrolled, three received at least one baseline and one follow-up scan.
BOR in 2 of 3 patients with at least one follow up scan is:
Stable disease in one CPI-failure renal cell carcinoma patient with a 24% reduction in target lesions.
Partial response in one patient with a PD-L1 negative mucoepidermoid carcinoma and a 54% reduction in target lesions and a complete response in non-target lesions.
Eight patients remain on treatment.
Biomarkers

Dose-dependent induction of on-target pro-inflammatory cytokines and chemokines.
Dose-dependent increases in non-classical monocytes, CD4+ and CD8+ T cells, and NK cells.
Safety

No dose limiting toxicities (DLTs) observed in any patient at any dose level.
No evidence of cytokine release syndrome in any patient at any dose level.
Conference Presentations

Co-organized the 3rd Annual VISTA Symposium, with Hummingbird Bioscience and Dartmouth Giesel School of Medicine, held virtually on March 27, 2024.
Presented clinical and preclinical data on VISTA blocking KVA12123 at the Keystone Symposia of Cancer Immunotherapy: Beyond Immune Checkpoint Blockade and Overcoming Resistance.
Presented new preclinical data on KVA12123 in acute myeloid leukemia (AML) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Blood Cancer Discovery Symposium.
ANTICIPATED FUTURE MILESTONES

Additional KVA12123 monotherapy safety and efficacy data in Q2 2024.
Additional KVA12123 and pembrolizumab combination therapy data in Q2 2024.
FIRST QUARTER 2024 FINANCIAL HIGHLIGHTS

Cash position: As of March 31, 2024, cash was $1.8 million, compared to $5.8 million as of December 31, 2023. The decrease was primarily due to cash used for clinical trial development of KVA12123 as well as general corporate purposes. As of March 31, 2024, we had $1.8 million in cash, and there is substantial doubt about our ability to continue as a going concern. In April 2024, we received a cash investment of $500,000 from an existing investor in connection with settlement of claims relating to the prior failure to fund by certain investors in the private placement. We are pursuing litigation against the other two larger investors who did not fund. Based on our current operating plans, we do not have sufficient cash and cash equivalents to fund our operating expenses and capital expenditures for at least the next 12 months from the filing date of our Quarterly Report on Form 10-Q for the three months ended March 31, 2024, which we expect to file on May 15, 2024, and there is substantial doubt about our ability to continue as a going concern.
Revenues: Total revenues were zero for the three months ended March 31, 2024 and $281,000 for the three months ended March 31, 2023. Revenues in 2023 were primarily due to providing research services provided under the Merck Neuromuscular License Agreement, which we completed in June 2023.
Research and development (R&D) expense: R&D expenses were $2.7 million for the three months ended March 31, 2024 and $2.8 million for the three months ended March 31, 2023. The decrease in R&D expenses was primarily due to lower facilities allocations expense as we transitioned to clinical trials in 2023 and ceased using our laboratory space, partially offset by higher activities for KVA12123, our lead product candidate, and CD27 licensing expense.
General and administrative expense: General and administrative expenses were $3.7 million for the three months ended March 31, 2024 and $3.9 million for the three months ended March 31, 2023. The decrease was primarily due to a decrease in personnel costs of $538,000 and other administrative expenses of $328,000, partially offset by an increase in professional services of $441,000 and higher facilities allocation of $181,000.
Net loss: Net loss was $10.2 million, or $0.89 per basic and diluted share, for the three months ended March 31, 2024 compared to a net loss of $6.5 million, or $0.77 per basic and diluted share, for the three months ended March 31, 2023.

On May 15, 2024 IMUNON, a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, reported that an abstract describing a Phase 2 study with IMNN-001 plus bevacizumab (Avastin) and neoadjuvant chemotherapy in advanced epithelial ovarian cancer patients has been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, to be held in Chicago from May 31st to June 4th (Press release, IMUNON, MAY 15, 2024, View Source [SID1234643322]).

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The abstract, titled "A phase II study evaluating the effect of IMNN-001 on second-look laparoscopy when administered in combination with bevacizumab and neoadjuvant chemotherapy in patients newly diagnosed with advanced epithelial ovarian cancer," will be presented on June 3rd at the Gynecologic Cancer session between 9:00 a.m. and 12:00 p.m. CT by lead investigator Amir A Jazaeri, M.D., Professor of Gynecological Oncology & Reproductive Medicine at The University of Texas MD Anderson Cancer Center. The study is actively recruiting patients in the U.S.

Abstract #: TPS5633
Poster Board #: 498a
Session Title: Gynecologic Cancer
Location: Hall A

"This study, substantially funded by Break Through Cancer, and with MD Anderson as the leading clinical site, is a pivotal part of IMUNON’s IL-12 gene therapy development for women with ovarian cancer. The combination with bevacizumab makes a lot of sense as we have observed synergies in pre-clinical experiments. We hope to complete enrollment of this study quickly to answer this important clinical question," said Dr. Sebastien Hazard, IMUNON’ chief medical officer.

On May 15, 2024 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, reported financial results and recent business highlights for its first quarter ended March 31, 2024 (Press release, HCW Biologics, MAY 15, 2024, View Source [SID1234643321]).

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Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, "We reached an important clinical development milestone in the first quarter of 2024. Enrollment was completed in two ongoing clinical trials to evaluate HCW9218 in solid tumors. We are encouraged by the number of patients with evidence of stable disease, even though it is difficult of generalize from Phase 1 and Phase 1b results. We are following our strategy to participate in fully randomized Phase 2 clinical trials in difficult-to-treat cancer indications, working with leading clinical sites. Using this strategy, we believe we can cost effectively evaluate HCW9218 as a single arm in a larger study. We intend to advance our cancer studies in ovarian and pancreatic cancer, while seeking to opportunistically participate in other cancer trials that have strong sponsors with financial support."

He added, "With the recommended Phase 2 dose established in our early studies, we plan to expand into age-related indications in skin diseases and conditions associated with senescence. These studies will be designed as investigative studies, and we anticipate that it will be quicker to see human data read outs from this type of indication than would be possible in a cancer study. We are interested to see the aesthetic effects with the deep wrinkles and senile lentigo, perhaps as secondary endpoints."

Business Highlights

•
The Company raised $6.1 million to date in 2024, from private placement of common stock and issuance of senior secured notes.
•
Management financing plans are to raise a bridge financing through the issuance of up to an aggregate of $10.0 million of Secured Notes, of which $3.6 million have been issued to date in 2024. If we succeed, we expect the bridge financing will enable the Company to continue with its clinical development plans, until such time as it can complete planned business development transactions such as license for non-core assets and capital raising transactions.
•
The Phase 1 clinical trial to evaluate HCW9218 in solid tumors and the Phase 1b clinical trial to evaluate HCW9218 in pancreatic cancer were completed in February 2024. The studies met the primary objective to determine a recommended Phase 2 dose ("RP2D").
•
In February 2024, we entered into an agreement with University of Pittsburgh Medical Center ("UPMC") to conduct an Investigator-sponsored Phase 2 clinical trial to evaluate HCW9218 in patients with metastatic advanced stage ovarian cancer in combination with neoadjuvant chemotherapy. Patient enrollment is expected to begin in the second half of 2024.
•
We are preparing an IND application to evaluate our IL-2 based product candidate designed to activate and expand Treg cells, HCW9302, in an autoimmune disease, which we plan to submit in the third quarter of 2024.

First Quarter 2024 Financial Results
Revenues: Revenues for the first quarters ended March 31, 2023 and 2024 were $41,883 and $1.1 million, respectively. Revenues in both periods were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. The licensed molecules are one of the inputs for manufacturing Wugen’s products. In 2023, revenues were negatively impacted by changes in Wugen’s clinical development program. In addition, Wugen suffered delays in ramping up its manufacturing process which also limited purchases of molecules licensed by the Company in 2023.
•
Research and development (R&D) expenses: R&D expenses for the first quarters ended March 31, 2023 and 2024 were $2.3 million and $2.1 million, respectively. The $132,529 decrease, or 6%, resulted primarily from a decline in preclinical expenses, partially offset by an increase in manufacturing and material costs. Manufacturing costs increased in three-month period ended March 31, 2024 because the Company replenished supply of a high-expressing cell line of HCW9101. Preclinical expenses declined primarily due to a change in the preclinical activities in March 31, 2024 versus the comparable period one year earlier. In the three-month period ended March 31, 2023, preclinical costs were incurred for setup costs for toxicology studies and other IND-enabling studies to prepare an IND application to obtain permission from the FDA to evaluate HCW9302 in an autoimmune indication. In the three-month period ended March 31, 2024, costs were incurred for supplemental research studies required for this IND application. Clinical trial expenses were incurred in the three-month period ended March 31, 2023 related to two ongoing clinical studies to evaluate HCW9218 in chemo-refractory / chemo-resistant solid tumors, including a Phase 1 study in patients with various types of solid tumors and a Phase 1b study in pancreatic cancer.
•
General and administrative (G&A) expenses: G&A expenses for the first quarters ended March 31, 2023 and 2024 were $3.1 million and $6.0 million, respectively, a $2.9 million increase, or 94%. The increase was primarily attributable to an increase in legal expenses related to the Altor/NantCell matter. See further discussion of the Altor/NantCell arbitration in "Financial Guidance."
•
Net loss: Net loss for the three-month periods ended March 31, 2023 and 2024 was $5.1 million and $7.5 million, respectively.

Financial Guidance

As of March 31, 2024, the Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the issuance date of the condensed financial statements, without additional funding or financial support. After giving consideration to the elements of the Company’s financing plan that were probable to occur within a year of the date of issuance, the Company concluded that substantial doubt was not alleviated in its going concern analysis.

Management has made some reductions in costs, but in order to continue the clinical development for the Company’s lead product candidates, the Company must maintain a core group of scientists. The Company continues to pursue a plan to obtain bridge financing through the issuance of up to $10.0 million in Secured Notes, $3.6 million of which have been issued to date in 2024. The Company anticipates that this bridge financing, if fully subscribed, will allow the Company to reach such time as it can execute plans for business development transactions such as licenses for non-core assets and capital-raising transactions, although there can be no assurance of this outcome for many reasons, including the uncertainties regarding the Company’s ongoing arbitration proceedings with Altor/NantCell, as described below. In addition to the bridge financing in the form of the issuance of additional Secured Notes, other potential near-term financing plans may include cooperative agreements for clinical trials and third-party collaboration funding. If the Company is not successful in raising additional capital, management has the intent and ability to revise its business plan and reduce costs. If such revisions are insufficient, the Company may have to curtail or cease operations.

On December 23, 2022, Claimants Altor and NantCell ("Altor/NantCell") filed a complaint against the Company in the U.S. District Court for the Southern District of Florida (the "Court"), alleging claims of misappropriation of trade secrets, tortious interference with contractual relations, inducement of breach of fiduciary duty, and specific performance/injunction for assignment of patents and patent applications, among other claims. That same day, Altor/NantCell also initiated an arbitration against the Company’s CEO and Founder, Dr. Wong, based on nearly identical allegations and alleging breach of contract, breach of fiduciary duty, and fraudulent concealment, among other claims. The Company moved to compel arbitration and the parties ultimately stipulated to the same. On April 27, 2023, in connection with the Altor/NantCell matter, the Court approved the parties’ stipulation and ordered the parties to arbitration. On May 1, 2023, Altor/NantCell filed a demand against the Company before JAMS. On May 3, 2023, Altor/NantCell dismissed the federal court action without prejudice and the Court ordered the case dismissed without prejudice and closed the case. Altor/NantCell’s proceeding against the Company is now proceeding in arbitration before JAMS and is consolidated with the arbitration Altor/NantCell initiated against Dr. Wong. The arbitration hearing scheduled to begin on May 20, 2024. In addition, on March 26, 2024, Altor/NantCell filed a complaint (the "Complaint") against the Company in the Chancery Court of the State of Delaware for the contribution of legal fees and expenses advanced to Dr. Wong in connection with the arbitration discussed above. Prior to the filing of the Complaint, Altor/NantCell had previously sought advancement from the Company and the Company agreed to advance 50% of Dr. Wong’s legal fees going forward from December 2023. On January 8, 2024, Altor/NantCell reserved their right to pursue contribution against the Company for 50% of the amount Altor/NantCell sent for advancement of expenses for Dr. Wong. In the Complaint, Altor/NantCell seek 50% of the fees they have already advanced to Dr. Wong, a declaration that the Company has an obligation to contribute 50% of the advancement of Dr. Wong’s expenses including 50% of Dr. Wong’s expenses incurred in connection with the arbitration through final resolution of the matter, and costs and fees in bringing this action. Although adverse decisions (or settlements) may occur in arbitration, it is not possible to reasonably estimate the possible loss or range of loss, if any, associated therewith at this time. As such, no accrual for these matters has been recorded

On May 15, 2024 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, reported financial results and recent corporate highlights for the first quarter ended March 31, 2024 (Press release, Fortress Biotech, MAY 15, 2024, View Source [SID1234643320]).

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "We achieved first quarter year-over-year product revenue growth of 7%, which was driven by greater than 20% year-over-year growth in our flagship products, Qbrexza and Accutane. In the first quarter of 2024, the U.S. Food and Drug Administration ("FDA") accepted the New Drug Application ("NDA") filing for DFD-29 and set a Prescription Drug User Fee Act ("PDUFA") goal date of November 4, 2024. If approved, DFD-29 has the potential to be the only oral, systemic therapy to address inflammatory lesions and erythema (redness) from rosacea, differentiating it as a potential best-in-class solution for the millions of patients suffering from rosacea. We also dosed the first patient in a multi-center Phase 2 study for Triplex for control of cytomegalovirus ("CMV") in patients undergoing liver transplantation and received grant funding from the National Institutes of Health ("NIH") to further advance cell and gene therapy candidates for the potential treatment of adults living with HIV and children with Menkes disease. Looking ahead, our expansive portfolio of development-stage programs across multiple areas, including oncology, dermatology, and rare diseases, holds the potential for up to three NDA and Biologics License Application ("BLA") regulatory approvals within the next 12 months and potentially a fourth BLA filing as early as 2025. Additionally, we anticipate multiple data readouts this year, including topline data from the Phase 1b/2a clinical trial of AJ201 to treat spinal and bulbar muscular atrophy ("SBMA"), data from the Phase 1b clinical trial of dotinurad for the treatment of gout and hyperuricemia and topline Phase 2 clinical data of Triplex, a CMV vaccine for adults co-infected with HIV and CMV. This sustained progress underscores the strength of Fortress’ business model, centered on acquiring and advancing assets that address unmet medical needs and enhance long-term value for shareholders through product revenues, equity holdings and royalties."

Recent Corporate Highlights1:

Regulatory Milestones and Updates

· In March 2024, the FDA accepted the NDA for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) and set a PDUFA goal date of November 4, 2024. We submitted the NDA to the FDA seeking approval for DFD-29 for the treatment of inflammatory lesions and erythema of rosacea in adults in January 2024. Both double blinded, randomized controlled DFD-29 Phase 3 clinical trials achieved their co-primary and all secondary endpoints with subjects completing the 16-week treatment with no significant safety issues. DFD-29 demonstrated statistical superiority compared to both Oracea capsules and placebo for Investigator’s Global Assessment (IGA) treatment success and the reduction in the total inflammatory lesion count in both clinical trials. Additionally, DFD-29 showed significantly superior reduction in Clinicians Erythema Assessment compared to placebo in both of the Phase 3 clinical trials. DFD-29 is currently in development at our partner company, Journey Medical Corporation (Nasdaq: DERM) ("Journey Medical").
· The CUTX-101 rolling NDA submission is ongoing and is expected to be completed by our partner, Sentynl Therapeutics, Inc. in 2024. Cyprium, our subsidiary company that developed CUTX-101, will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101.
· We submitted a BLA to the FDA for cosibelimab, our investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation, in January 2023. In December 2023, the FDA issued a complete response letter ("CRL") for the cosibelimab BLA. The CRL solely cited findings that arose during a multi-sponsor inspection of a third-party contract manufacturing organization as approvability issues to address in a resubmission. The CRL did not state any concerns about the clinical data package, safety or labeling for the approvability of cosibelimab. We intend to seek to address the feedback in a potential BLA resubmission, which is currently targeted for mid-year. Cosibelimab is currently in development at our partner company, Checkpoint Therapeutics, Inc. (Nasdaq: CKPT) ("Checkpoint").
· Based on its public statements, AstraZeneca plc has estimated that it expects the FDA to accept its BLA submission of CAEL-101 (anselamimab) to treat AL amyloidosis for review as early as 2025.

Clinical Updates

· The Phase 2 clinical trial of Triplex, a CMV vaccine, for adults co-infected with HIV and CMV is now fully enrolled with topline data anticipated in the fourth quarter of 2024. The study aims to show that vaccination with Triplex can safely elicit a CMV-specific immune response and reduce asymptomatic CMV replication in a population of people with HIV on suppressive antiretroviral therapy. The study will also evaluate whether this intervention might reduce chronic inflammation and immune activation, as compared to placebo, and thus, potentially reduce related mortality and morbidity.
· In May 2024, we announced that the first patient was dosed in a multi-center, placebo-controlled, randomized Phase 2 study of Triplex for control of CMV in patients undergoing liver transplantation. The trial is funded by a grant from the NIH’s National Institute of Allergy and Infectious Diseases of the (NIH/NIAID) that could provide over $20 million in non-dilutive funding. Triplex is currently in development at our subsidiary company, Helocyte, Inc.
· A Phase 1b clinical trial in patients with gout and hyperuricemia is ongoing in the U.S. to confirm the comparability of U.S. patients’ response to dotinurad (urate transporter (URAT1) inhibitor) with data generated in Japan, and to assess drug-drug interactions, if any, with allopurinol. We expect to announce data from this trial in mid-2024. Dotinurad is currently in development at our subsidiary company, Urica Therapeutics, Inc. ("Urica").

Commercial Product Updates

· Journey Medical’s total revenues for the first quarter ended March 31, 2024 were $13.0 million, an increase of $0.8 million, or 7%, compared to total net revenues of $12.2 million for the first quarter ended March 31, 2023.

1 The development programs depicted in this press release include product candidates in development at Fortress, at Fortress’ private subsidiaries (referred to herein as "subsidiaries"), at Fortress’ public subsidiaries (referred to herein as "partner companies") and at entities with whom one of the foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment obligation (such entities referred to herein as "partners"). The words "we", "us" and "our" may refer to Fortress individually, to one or more of our subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context.

General Corporate:

· In January 2024, Fortress raised gross proceeds of approximately $11.0 million in a registered direct offering priced at-the-market under Nasdaq rules.
· In January 2024, Checkpoint raised gross proceeds of approximately $14.0 million in a registered direct offering, and Avenue raised approximately $5.0 million gross proceeds from warrant exercise transactions.

Financial Results:

· As of March 31, 2024, Fortress’ consolidated cash, cash equivalents and restricted cash totaled $85.8 million, compared to $83.4 million as of December 31, 2023, an increase of $2.5 million during the quarter.
· Fortress’ consolidated cash, cash equivalents and restricted cash, totaling $85.8 million as of March 31, 2024, includes $45.6 million attributable to Fortress and the private subsidiaries, $3.2 million attributable to Avenue, $11.2 million attributable to Checkpoint, $1.7 million attributable to Mustang Bio and $24.1 million attributable to Journey Medical.
o Fortress’ consolidated cash, cash equivalents and restricted cash, totaled $83.4 million as of December 31, 2023, which included $42.2 million attributable to Fortress and private subsidiaries, $1.8 million attributable to Avenue, $4.9 million attributable to Checkpoint, $7.0 million attributable to Mustang Bio and $27.4 million attributable to Journey Medical.
· Subsequent to the end of the first quarter, in May 2024, Avenue raised approximately $4.4 million in gross proceeds from warrant exercise transactions and Mustang raised approximately $4.0 million in gross proceeds from a public offering of common stock and warrants.
· Fortress’ consolidated net revenue totaled $13.0 million for the first quarter ended March 31, 2024, all of which was generated from our marketed dermatology products. This compares to consolidated revenue totaling $12.4 million for the first quarter of 2023, which included $12.2 million in revenue generated from our marketed dermatology products.
· Consolidated research and development expenses including license acquisitions totaled $24.8 million for the first quarter ended March 31, 2024, compared to $39.5 million for the first quarter ended March 31, 2023.
· Consolidated selling, general and administrative costs were $17.9 million for the first quarter ended March 31, 2024, compared to $25.3 million for the first quarter ended March 31, 2023.
· Consolidated net loss attributable to common stockholders was $(17.7) million, or $(1.03) per share, for the first quarter ended March 31, 2024, compared to net loss attributable to common stockholders of $(23.5) million, or $(3.47) per share for the first quarter ended March 31, 2023.
· All share and per share information has been retroactively adjusted to give effect to the Company’s October 2023 1-for-15 reverse stock split for all periods presented, unless otherwise indicated.