On November 14, 2023 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, reported financial results for the three and nine months ended September 30, 2023 and highlighted recent corporate updates (Press release, Heron Therapeutics, NOV 14, 2023, View Source [SID1234637626]).

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Craig Collard, Chief Executive Officer, commented, "In just six months of initiating our corporate restructuring plan, I am pleased to announce its near completion. The enhanced clarity in our sales projections and operational visibility brings optimism for our path to profitability. I am delighted to offer this quarterly update on our expectations for the fourth quarter and to unveil our 2024 guidance. Heron is now strategically positioned to deliver substantial value in the coming years, boasting a robust balance sheet, a dedicated management team, and a steadfast commitment to operational excellence."

Corporate Updates

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Guidance for 2023 and 2024:

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The Company is updating guidance for the remainder of 2023 and establishing guidance for the full year 2024 that reflects the growth potential of the product portfolio and the output of our continual operational improvements. Based on our current operational plan, we expect the Company to have sufficient capital to achieve profitability:

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Full-year 2023 net product sales are expected to be in the range of $123 million to $125 million.
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Full-year 2023 net product sales guidance for the oncology care franchise is being increased to a range of $104 million to $106 million from a prior range of $99 million to $103 million.
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EBITDA (excluding stock compensation) expected in the range of ($10 million) to ($6 million) in the fourth quarter of 2023.
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Full-year 2024 net product sales are expected to be in the range of $138 million to $158 million, with our oncology care franchise growing 3% to 5% in 2024 over 2023. and the acute care franchise growing in excess of 48% year-over-year.

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Full-year 2024 operating expenses (excluding stock compensation, depreciation and amortization) are expected to be in the range of $108 million to $116 million
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Full-year 2024 EBITDA (excluding stock compensation) expected to be in the range of ($22 million) to $3 million.
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Positive EBITDA (excluding stock compensation) is expected during the fourth quarter of 2024.
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Expected year-end 2023 cash, cash equivalents, and short-term investments to exceed $65 million with additional access to $25 million from our working capital facility.
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Gross margin is expected to improve from 41% in 2023 to 69% in 2024, and to over 75% in 2025 and beyond.

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Adjustments during Third Quarter 2023:

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Inventory write-offs during the quarter totaled $7.5 million as a reflection of our reforecast of the ZYNRELEF product launch. Had we not incurred the write-offs, gross profit for the quarter would have been $20.7 million, or a gross margin of approximately 66%. We do not currently anticipate additional inventory write-offs in the future.

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One-time expenses during the quarter were $4.1 million, consisting of reorganization costs and severance charges.

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Loss from operations was $24.9 million for the quarter. Excluding inventory write-offs and one-time expenses, loss from operations would have been $13.3 million.

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Financings:

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In July 2023, Heron completed a private placement equity financing with net proceeds from the sale of Company’s common stock and pre-funded warrants of $29.8 million.

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In August 2023, Heron entered into a working capital facility, providing for an aggregate gross principal amount of up to $50.0 million in working capital for the Company, subject to certain terms and conditions, with $24.4 million in net proceeds drawn at closing.

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Product Development: The Vial Access Needle ("VAN") program remains on track for a Prior Approval Supplement ("PAS") submission in early 2024 and an anticipated launch in the third quarter of 2024.

Acute Care Franchise

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Acute Care Franchise Net Product Sales: For the three and nine months ended September 30, 2023, acute care franchise net product sales were $4.7 million and $12.9 million, respectively, which increased from $2.7 million and $6.3 million, respectively, for the same periods in 2022.

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ZYNRELEF Net Product Sales and PDUFA Date:

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Net product sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three and nine months ended September 30, 2023 were $4.4 million and $12.0 million, respectively, which increased from $2.7 million and $6.3 million, respectively, for the same periods in 2022.

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The Prescription Drug User Fee Act ("PDUFA") action date for the supplemental New Drug Application ("sNDA") for the ZYNRELEF expanded label is on track for January 23, 2024.

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APONVIE Net Product Sales: Net product sales of APONVIE for the three and nine months ended September 30, 2023 were $0.3 million and $0.9 million, respectively, with no sales in the comparable prior year periods. APONVIE became commercially available in the U.S. on March 6, 2023.

Oncology Care Franchise

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Oncology Care Franchise Net Product Sales: For the three and nine months ended September 30, 2023, oncology care franchise net product sales were $26.7 million and $79.9 million, respectively, which increased from $23.9 million and $71.3 million, respectively, for the same periods in 2022.

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CINVANTI Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and nine months ended September 30, 2023 were $23.3 million and $70.6 million, respectively, which increased from $21.2 million and $64.2 million, respectively, for the same periods in 2022.

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CINVANTI ANDA Litigation: Heron had a favorable outcome at the Markman hearing in the pending Hatch-Waxman Abbreviated New Drug Application litigation against Fresenius Kabi to enforce our CINVANTI patents. We are pleased with the outcome and will continue to vigorously enforce and defend our patent portfolio.

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SUSTOL Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and nine months ended September 30, 2023 were $3.4 million and $9.3 million, respectively, which increased from $2.7 million and $7.1 million, respectively, for the same periods in 2022.

Conference Call and Webcast

Heron will host a conference call and webcast on November 14, 2023 at 4:30 p.m. ET. The conference call can be accessed by dialing (646) 307-1963 for domestic callers and (800) 715-9871 for international callers. Please provide the operator with the passcode 5940799 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron’s website for 60 days following the call.

On November 14, 2023 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 third quarter ended September 30, 2023 (Press release, HCW Biologics, NOV 14, 2023, View Source [SID1234637625]).

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A human data readout from the ongoing Phase 1 clinical trial to evaluate HCW9218 in patients with chemo-refractory/chemo-resistant solid tumors was presented at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC") by Melissa A. Geller, M.D., M.S., Professor and Division Director of Gynecologic Oncology in the Department of Obstetrics, Gynecology and Women’s Health at the University of Minnesota, who serves as a Principal Investigator of this trial, which is sponsored by the University of Minnesota.

Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, "We believe the findings we shared in the preliminary human data readout at SITC (Free SITC Whitepaper) provide support for future Phase 2 studies of HCW9218 in combination with chemotherapy and/or immune checkpoint inhibitors against solid tumors in patients with ovarian cancer. We are pleased to see the consistency of results in humans with those that we saw in our preclinical animal studies. Together, we believe these findings verify the balanced bifunctional activities of HCW9218 in stimulating effector immune cells and reducing TGF-β-mediated responses."

Business Highlights:

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The Company expects to complete the initial phase of both of its ongoing clinical studies in cancer indications in late 2023 or early 2024.
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Highlights of the human data readout from the Phase 1 clinical trial presented at SITC (Free SITC Whitepaper) include:

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HCW9218 was administered subcutaneously once every three weeks for up to six cycles at dose levels 0.25 mg/kg (DL1), 0.5 mg/kg (DL2), 0.8 mg/kg (DL3) or 1.2 mg/kg (DL4). The median number of cycles was three.

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87% (13/15) had >4 lines of prior therapy. Tumor types included: Ovarian (n=6), Colorectal (n=4), Rectal (n=3), and Liver (n=2).

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53% (8/15) patients treated with HCW9218 were evaluated in a post-treatment assessment, including biopsies and scanning. Tumor types included: Ovarian (n=3), Colorectal (n=3), Rectal (n= 1) and Liver (n=1).

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50% (4/8) patients evaluated in post-treatment assessments exhibited stable disease following HCW9218 treatment. Patients showed stable disease lasting over 6 months. Clinical benefit was observed from DL2, DL3 and DL4.

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66% (2/3) patients with ovarian cancer who underwent post-treatment assessments showed stable disease.

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HCW9218 significantly reduced blood levels of TGF-β in cancer patients in a dose-dependent manner, without causing treatment-emergent skin lesions and bleeding events previously reported with TGF-β antagonists in clinic.

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Based on the ability of HCW9218 to activate, expand and induce tumor trafficking of progenitor exhausted stem-like and transitory CD8+ T cells, HCW9218 treatment presents a promising approach to enhancing the antitumor activity of immune checkpoint inhibitors in patients with solid tumors.

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Repeated HCW9218 administration at up to the highest planned dose level was well tolerated by patients with chemotherapy-refractory advanced solid tumors, which has provided support for the Recommended Phase 2 Dose level for future Phase 2 studies of HCW9218.

Third Quarter 2023 Financial Results:

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Revenues: Revenues for the quarter ended September 30, 2022 and 2023 were $1.8 million and $853,102, respectively. Revenues for the nine months ended September 30, 2022 and 2023 were $5.4 million and $1.5 million, respectively. Revenues 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. The Company expects Wugen to limit its purchases for the remainder of 2023, due primarily to changes in its clinical development program and delays in ramping up its manufacturing process.

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Research and development (R&D) expenses: R&D expenses for the quarter ended September 30, 2022 and 2023 were $2.6 million and $1.7 million, respectively, a decrease of $981,352, or 37%. R&D expenses for the nine months ended September 30, 2022 and 2023 were $6.4 million and $5.5 million, respectively, a decrease of $868,434, or 14%. The change is primarily attributable to a decrease in preclinical expenses and manufacturing costs and an increase in costs associated with clinical trial activities. As of September 30, 2023, the Company anticipates it has the required supplies of its lead molecules, HCW9218 and HCW9302, in place to provide for planned clinical development activities for the next 20-24 months. In the three months ended September 30, 2023, costs were incurred primarily for master cell bank characterization for HCW9101H, a high-producing cell line of a key component of the manufacturing process for the Company’s proprietary molecules including those licensed to Wugen, as well as ancillary activities such as shipping, insurance and storage. During this period, all preclinical costs were incurred to complete IND-enabling activities for HCW9302. The Company expects to submit an IND application for permission to conduct a clinical trial to evaluate HCW9302 in an autoimmune disorder by the end of 2023.

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General and administrative (G&A) expenses: G&A expenses for the quarter ended September 30, 2022 and 2023 were $1.7 million and $3.6 million, respectively, an increase of $1.9 million, or 107%. G&A expenses for the nine months ended September 30, 2022 and 2023 were $5.3 million and $9.7 million, respectively, an increase of $4.4 million, or 83%. The increase was primarily attributable to increases in professional fees, which include legal fees associated with legal proceedings brought against the Company by Altor BioScience, LLC and NantCell, Inc., or Altor/NantCell, which is discussed further below.

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Net loss: Net loss for the quarter ended September 30, 2022 and 2023 was $3.9 million and $4.9 million, respectively, an increase of $1.0 million, or 26%. Net loss for the nine months ended September 30, 2022 and 2023 was $9.5 million and $14.3 million, respectively, an increase of $4.8 million, or 51%.

Financial Guidance

As of September 30, 2023, the Company held $11.2 million in cash and cash equivalents. In addition, the Company recognized prepaid expenses of $1.7 million, and a deposit for interest reserve of $5.3 million. The Company advanced $4.4 million toward its new lab and manufacturing facilities prior to drawing funds available under the 2023 Loan Agreement. With the current cash and cash equivalents and funds available to the Company under the 2023 Loan Agreement, including recouping the amounts advanced toward its new lab and manufacturing facilities, the Company believes it has adequate capital to fund operations and other commitments to the end of 2024.

On April 27, 2023, in connection with the Altor/NantCell matter, the U.S. District Court for the Southern District of Florida (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. 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 within the Company’s financial statements. In the year ahead, the Company expects to continue to incur legal expenses on its own behalf in connection with the legal proceedings brought against it by Altor/NantCell. Further, while legal expenses incurred by Dr. Wong in connection with the arbitration against him that was initiated by Altor/NantCell are covered through advancement of expenses from Altor/NantCell, under certain circumstances, the Company may be required to advance his legal fees. The Company incurred legal expenses on its own behalf in the period ended September 30, 2023, and it expects to continue to incur material costs and expenses in connection with defending itself in the foregoing legal matters through the end of 2023 and into 2024.

On November 14, 2023 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the third quarter ended September 30, 2023 and provided recent corporate updates (Press release, Galera Therapeutics, NOV 14, 2023, View Source [SID1234637624]).

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"Given the considerable time and investment required for additional clinical trials, we find it prudent to explore strategic options," said Mel Sorensen, M.D., Galera’s President and CEO. "We also made the difficult decision to discontinue our GRECO trials, which we believe is an appropriate step towards cash conservation and maximizing value for our shareholders. We extend our gratitude to all the patients, research teams, and dedicated employees who have contributed to the advances we have made."

Recent Corporate Updates

Radiotherapy-Induced Severe Oral Mucositis (SOM)

In August 2023, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for avasopasem manganese (avasopasem) for radiotherapy-induced SOM in patients with head and neck cancer (HNC) undergoing standard-of-care treatment. In the CRL, the FDA communicated that the data from the Phase 2b GT-201 and Phase 3 ROMAN trials were not sufficient for approval and that an additional clinical trial will be required for an NDA resubmission.
In September 2023, the Company held a Type A meeting with the FDA to understand the FDA’s rationale for its decision and discuss next steps to support an NDA resubmission.
In October 2023, the Company received official meeting minutes from the Type A meeting in which the FDA reiterated the need for an additional Phase 3 trial to support resubmission. The Company is exploring potential strategic alternatives, as it is not feasible to conduct an additional trial with the Company’s current resources.
Cisplatin-Related Chronic Kidney Disease (CKD)

In November 2023, the cisplatin-related CKD data from the Phase 3 ROMAN trial was presented at the American Society of Nephrology (ASN) Kidney Week 2023 meeting, which took place November 2-5 in Philadelphia, PA. The oral presentation, titled "Effects of Avasopasem On Rates of Cisplatin-Induced Acute Kidney Injury and Chronic Kidney Disease," described significant reduction in the incidence of CKD one year following treatment with cisplatin in the avasopasem arm, reducing CKD by 50% compared to placebo. This was a prospectively defined endpoint of the ROMAN trial, and the reduction was seen with both cisplatin dosing schedules and across all stages of CKD. The result paralleled improvements in preservation of kidney function across the entire population observed from three months through one year. Lower incidence of renal adverse events was also observed in the avasopasem arm compared to placebo during the treatment phase.
Locally Advanced Pancreatic Cancer (LAPC)

In October 2023, the Company decided to halt the Phase 2b GRECO-2 trial of rucosopasem manganese (rucosopasem) in patients with LAPC, following a futility analysis of the trial. The analysis indicated that the trial was unlikely to succeed as designed. GRECO-2 is a randomized, double-blind, placebo-controlled trial evaluating rucosopasem or placebo in combination with stereotactic body radiation therapy (SBRT) in patients with LAPC. Overall survival was the trial’s primary endpoint. The trial was designed to enroll 220 patients with final analysis at 120 events (deaths). The trial had enrolled 177 patients by the date of the decision to halt the trial, and the futility analysis was conducted based on 35 deaths with a data cutoff of October 9, 2023.
Non-Small Cell Lung Cancer (NSCLC)

In October 2023, the Company decided to halt the randomized, placebo-controlled Phase 1/2 GRECO-1 trial of rucosopasem in patients with NCSLC, following the futility analysis of the GRECO-2 trial.
In October 2023, a poster featuring rucosopasem preclinical data was presented at the 2023 American Society for Radiation Oncology (ASTRO) Annual Meeting, which took place October 1-3, 2023, in San Diego, CA. The poster, titled "Enhanced Peroxide Fluxes and Radiosensitization in Colorectal Tumors but Not Normal Enterocytes from the Combination of Superoxide Dismutase Mimetics and Pharmacological Ascorbate," noted that rucosopasem in combination with pharmacological ascorbate may sensitize tumors to clinically relevant radiotherapy doses while maintaining their normal tissue sparing effects.
General Corporate Updates

In connection with the CRL announcement in August 2023, the Company further announced a reduction in force, which reduced the Company’s workforce by 22 employees, or approximately 70%, as of August 9, 2023 ("Workforce Reduction"). The decision was based on cost-reduction initiatives intended to reduce operating expenses.
To maximize value for shareholders, the Company engaged Stifel, Nicolaus & Company, Inc. to undertake a comprehensive review of strategic alternatives for both the Company and its portfolio of dismutase mimetics. These strategic alternatives may include, but are not limited to, mergers, asset sales, divestiture, licensing arrangements, or other strategic transactions. If the Company is unable to undertake any strategic alternative, it may be required to cease operations. The Company has not set a timetable for completion of this evaluation process and does not intend to disclose further updates unless and until it is determined that further disclosure is appropriate or necessary.
Third Quarter 2023 Financial Highlights

Research and development expenses were $6.1 million in the third quarter of 2023, compared to $8.1 million for the same period in 2022. The decrease was primarily attributable to a decrease in avasopasem development costs and reduced personnel-related expenses due to the Workforce Reduction, partially offset by an increase in rucosopasem development costs.
General and administrative expenses were $5.0 million in the third quarter of 2023, compared to $4.9 million for the same period in 2022. The increase was primarily attributable to avasopasem commercial preparations and increased legal expenses, largely offset by reduced personnel-related expenses due to the Workforce Reduction and reduced insurance expense.
As a result of the Workforce Reduction, the Company incurred restructuring-related charges of $2.3 million in the third quarter of 2023, primarily consisting of severance payments, employee benefits and related costs.
Galera reported a net loss of $(15.1) million, or $(0.33) per share, for the third quarter of 2023, compared to a net loss of $(16.0) million, or $(0.60) per share, for the same period in 2022.
As of September 30, 2023, Galera had cash, cash equivalents and short-term investments of $28.4 million. Galera expects that its existing cash, cash equivalents and short-term investments, taking into account the discontinuation of the GRECO-1 and GRECO-2 trials, will enable Galera to fund its operating expenses and capital expenditure requirements into 2025.

On November 14, 2023 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, reported its financial results and recent corporate highlights for the third quarter ended September 30, 2023 (Press release, Fortress Biotech, NOV 14, 2023, View Source [SID1234637623]).

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "In the third quarter of 2023, Fortress and our partner companies and subsidiaries continued to advance our diverse portfolio of drug candidates. Our total consolidated net revenue this quarter was $34.8 million, which includes an upfront payment of $19 million that Journey Medical received upon entering into an exclusive license agreement with Maruho for commercialization of Qbrexza in additional territories in Asia. We’re looking forward to multiple significant near-term milestones, including potentially up to four New Drug Application ("NDA") and Biologics License Application ("BLA") submissions to the U.S. Food and Drug Administration ("FDA") between 2023 and 2025, one of which is a NDA for DFD-29 to treat rosacea around the end of this year. We are also anticipating the PDUFA goal date of January 3, 2024, for cosibelimab, our investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC")."

Recent Corporate Highlights2:

Marketed Dermatology Products

● Journey Medical Corporation (Nasdaq: DERM) ("Journey Medical"), our partner company, primarily focuses on selling and marketing of prescription dermatology products.
● In September 2023, Journey Medical entered into an exclusive license agreement with Maruho Co., Ltd. ("Maruho"), a Japanese company specializing in dermatology as well as Journey’s exclusive licensing partner that developed and is commercializing Qbrexza (Rapifort) in Japan. Under the terms of the Agreement, Journey Medical received a $19 million nonrefundable upfront payment
1 Includes CAEL-101, an asset in development at Caelum Biosciences (a former subsidiary now 100% owned by AstraZeneca’s Alexion) with respect to which Fortress remains eligible to receive substantial milestone payments.

2 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 which 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.

and granted Maruho an exclusive license to develop and commercialize Qbrexza (glycopyrronium tosylate hydrate) for the treatment of hyperhidrosis in South Korea, Taiwan, Hong Kong, Macau, Thailand, Indonesia, Malaysia, Philippines, Singapore, Vietnam, Brunei, Cambodia, Myanmar and Laos (the "Territory"). Maruho is responsible for all development and commercialization costs for the program throughout the Territory.
● Journey Medical’s total net revenues in the third quarter of 2023 were $34.5 million, an increase of $18.4 million, or 114%, compared to total net revenues of $16.1 million in the third quarter of 2022.
● Journey Medical’s total product net revenues were $15.3 million for the third quarter of 2023, compared to third quarter 2022 total product net revenues of $16.0 million.

Fortress, through its subsidiaries, partner companies and partners, has a broad and diverse pipeline of clinical-stage programs being evaluated in over 20 ongoing clinical trials. We look forward to potential filings of up to four NDA and BLA submissions from 2023 through 2025, including:

● DFD-29 – modified release oral minocycline for rosacea
● Cosibelimab – anti-PD-L1 antibody for solid tumors
● CUTX-101 – copper histidinate for Menkes disease
● CAEL-101 – light chain fibril-reactive monoclonal antibody for AL amyloidosis

We also expect to continue to advance our early-to-mid-clinical-stage candidates, some of which may begin pivotal trials during the next twelve to eighteen months, including:

● Dotinurad – urate transporter (URAT1) inhibitor for gout and hyperuricemia
● IV tramadol – intravenous small molecule for acute post-operative pain
● MB-106 – CD20-targeted CAR-T cell therapy for hematologic malignancies
● Triplex – multi-antigen, modified vaccinia Ankara-based (MVA) vaccine for cytomegalovirus (CMV)
● MB-117 – ex vivo lentiviral gene therapy for newborns with XSCID (X-linked severe combined immunodeficiency)
● MB-217 – ex vivo lentiviral gene therapy for previously transplanted children and young adults with XSCID
● AJ201 – Nrf1 and Nrf2 activator, androgen receptor degradation enhancer for spinal and bulbar muscular atrophy (SBMA), also known as Kennedy’s Disease
● BAER-101 – GABAA α2/3 positive allosteric modulator for refractory epilepsies
● MB-109 – IL13Rα2-targeted CAR-T cell therapy combined with HSV-1 oncolytic virus for recurrent glioblastoma and high-grade astrocytomas

General Corporate:

● In November 2023, Fortress raised approximately $10.0 million in gross proceeds in a public offering.
● In October 2023, Fortress effected a 1-for-15 reverse stock split of its issued and outstanding common stock to bring the Company into compliance with Nasdaq’s minimum bid price requirement for continued listing.

Financial Results:

● As of September 30, 2023, Fortress’ consolidated cash, cash equivalents and restricted cash totaled $74.7 million, compared to $89.2 million as of June 30, 2023, a decrease of $14.5 million during the quarter.
● Fortress’ consolidated cash, cash equivalents and restricted cash, totaling $74.7 million as of September 30, 2023, includes $37.7 million attributable to Fortress and private subsidiaries, $0.2
million attributable to Avenue, $1.8 million attributable to Checkpoint, $10.3 million attributable to Mustang Bio and $24.7 million attributable to Journey Medical.
● Subsequent to the end of the third quarter, in November 2023, Fortress raised approximately $10.0 million in gross proceeds in a public offering and Avenue raised approximately $5.0 million in gross proceeds in a public offering. In addition, in October 2023, Checkpoint raised approximately $11.1 million in gross proceeds from the exercise of warrants and Mustang Bio raised approximately $4.4 million in gross proceeds in a registered direct offering.
● Fortress’ consolidated net revenue totaled $34.8 million for the third quarter of 2023, which included $15.3 million in net product revenue generated from our marketed dermatology products. This compares to consolidated net revenue totaling $16.5 million for the third quarter of 2022, which included $16.0 million in net product revenue generated from our marketed dermatology products.
● Consolidated research and development expenses including license acquisitions were $20.3 million for the third quarter of 2023, compared to $29.9 million for the third quarter of 2022.
● Consolidated selling, general and administrative expenses were $21.7 million for the third quarter of 2023, compared to $30.1 million for the third quarter of 2022.
● Consolidated net loss attributable to common stockholders was $7.1 million, or $0.94 per share, for the third quarter of 2023, compared to consolidated net loss attributable to common stockholders of $24.5 million, or $4.11 per share for the third quarter of 2022.

On November 14, 2023 Eli Lilly and Company (NYSE: LLY) reported that it will attend the sixth annual Evercore ISI HealthCONx Conference on Nov. 28, 2023. Daniel Skovronsky, M.D., Ph.D., executive vice president, chief scientific and medical officer, and president of Lilly Research Laboratories, will participate in a fireside chat at 3:50 p.m., Eastern time (Press release, Eli Lilly, NOV 14, 2023, https://investor.lilly.com/news-releases/news-release-details/lilly-participate-evercore-isi-healthconx-conference-0 [SID1234637622]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.